Internasional

Depkes: Vaksin Meningitis tak Berenzim Babi

http://www.republika.co.id/koran/14/48813/Depkes_Vaksin_Meningitis_tak_Berenzim_Babi

Depkes: Vaksin Meningitis tak Berenzim Babi

Kamis, 07 Mei 2009 pukul 22:45:00

MEDAN — Departemen Kesehatan RI melalui Dirjen Pengendalian Penyakit dan Penyehatan Lingkungan (P2PL), Prof dr Tjandra Yoga Adhitama, memastikan bahwa vaksin meningitis yang disuntikkan kepada jamaah haji dan umrah tidak mengandung bahan dari babi. Untuk itu, para calon jamaah haji atau umrah diminta agar tak ragu dengan suntik meningitis yang dilakukan Depkes.

“Kepastian tidak adanya kandungan babi ini merupakan penjelasan resmi dari Depkes RI bahwa vaksin meningitis untuk calon jamaah haji dan umrah tidak mengandung bahan dari babi,” ujar Kepala Dinas Kesehatan Sumatra Utara, dr Candra Syafei SpOG, yang mengutip surat resmi dari Depkes tersebut, kemarin (6/5).

Dalam surat tertanggal 4 Mei 2009 yang dikeluarkan melalui Pusat Komunikasi Publik Depkes RI itu, Dirjen P2PL menyatakan, vaksin yang digunakan calon jamaah haji dan umrah Indonesia adalah vaksin meningitis Mencevax ACWY. Dalam proses pembuatannya, vaksin ini menggunakan kultur media yang bebas binatang, termasuk bebas dari >material bovine (sapi) dan porcine (babi).

“Jadi, vaksin meningitis yang digunakan jamaah haji dan umrah tidak mengandung unsur babi,” ujar Candra yang mengutip pernyataan Dirjen P2PL dalam surat tersebut. Bahkan, lanjut Candra, dalam surat tersebut, Depkes RI menyatakan, vaksin itu juga digunakan jamaah haji dari Arab Saudi, Iran, Nigeria, Yaman, Malaysia, Filipina, Singapura, Pakistan, Bangladesh, Ghana, India, Kazakstan, Kuwait, Lebanon, dan lain-lain.

Candra menambahkan, Pemerintah Arab Saudi mewajibkan setiap jamaah haji atau umrah divaksin meningitis agar terhindar dari penyakit radang selaput otak. Menurut dia, gejala klinis penyakit itu adalah demam (panas tinggi) mendadak, nyeri kepala, mual, muntah, ketahanan fisik melemah, dan kemerahan di kulit. Pada keadaan lanjut, kesadaran menurun sampai koma serta terjadi pendarahan.

“Berkumpulnya populasi dalam jumlah besar dari berbagai negara di Arab Saudi, seperti pada musim haji, berpotensi terhadap penyebaran kuman dan penyakit. Karena itu, pemberian vaksinasi merupakan upaya yang penting dalam memberi perlindungan kesehatan jamaah haji,” ujar Candra.

Penjelasan Depkes itu berbeda dengan hasil temuan Majelis Ulama Indonesia (MUI) dan LPPOM MUI Sumatra Selatan. Berdasarkan hasil penelitian dengan melibatkan Universitas Sriwijaya, LPPOM MUI Sumsel menemukan adanya kandungan enzim <I>porchin<I> dalam vaksin meningitis untuk jamaah haji dan umrah.

Direktur LPPOM MUI Pusat, Muhamad Nadratuzzaman Hosen, juga sempat mengatakan, kasus vaksin meningitis mengandung enzim babi ini merupakan kasus lama. ”Departemen Kesehatan juga tahu, tapi hanya didiamkan. Banyak vaksin yang mengandung enzim babi, bukan vaksin meningitis saja,” ungkapnya.  nin/hri

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Enzim Babi di Vaksin Meningitis Haji

http://www.republika.co.id/berita/46193/Enzim_Babi_di_Vaksin_Meningitis_Haji

Enzim Babi di Vaksin Meningitis HajiBy Republika Newsroom
Jumat, 24 April 2009 pukul 17:13:00

PALEMBANG — Majelis Ulama Indonesia Sumatera Selatan (MUI Sumsel) memperingatkan agar pemerintah mengganti vaksin meningitis yang digunakan untuk calon jemaah haji atau umrah karena vaksin tersebut diduga mengandung enzim dari babi.

Ketua MUI Sumsel KH Sodikun, Jum’at (24/4) mengatakan, Lembaga Pengkajian Pangan Obat-obatan dan Kosmetika Majelis Ulama Indonesia (LPPOM MUI) Sumsel telah melakukan penelitian dengan melibatkan pakar dari Fakultas Kedokteran Universitas Sriwijaya (Unsri)  ditemukan bahwa vaksin antiradang otak (antimeningitis) untuk calon jemaah haji tersebut menggunakan enzim porchin dari binatang babi.

“MUI Sumsel melakukan penelitian tersebut setelah sekitar tiga bulan lalu mendapat laporan tentang adanya kandungan enzim babi tersebut. Lalu LPPOM MUI dengan dipimpin ketuanya Prof Nasruddin Iljas melakukan penelitian dengan melibatkan pakar dari Unsri diantaranya Prof. T. Kamaludin Direktur Program Pasca Sarjana Unsri,” kata Sodikun memaparkan

“Hasilnya ditemukan adanya kandungan enzim porchin yang berasal dari binatang babi,” ujar Sodikun menambahkan.

Temuan tersebut menurut Sodikun sudah disampaikan kepada pemerintah dan MUI Pusat agar ditindaklanjuti.

“Kami meminta pemerintah segera mengganti vaksin yang digunakan sekarang dengan vaksin yang halal dan bebas darin enzim binatang yang diharamkan tersebut,” ujar Sodikin.

“Sampai sekarang permintaan kami tidak mendapat tanggapan. Melalui informasi yang kami sampaikan lewat media massa, MUI Sumsel berharap Menteri Agama segera tanggap,” imbuhnya.

Sebelumnya, Prof Nasruddin Iljas Ketua LPPOM MUI Sumsel menjelaskan, negara lain seperti Malaysia telah menggunakan vaksin meningitis yang halal dari sapi.

“Jadi sudah seharusnya pemerintah pusat, khususnya Departemen Agama segera mencari alternatif pengganti vaksin meningitis yang tidak mengandung binatang babi.”

Nasruddin mengatakan, jika produk makanan, obat-obatan serta kosmetik mengandung bahan yang tidak halal maka akan menghambat bahkan menyebabkan ibadah umat Islam sia-sia. “Ini harus menjadi perhatian. Apalagi sekarang marak beredar makanan yang berasal dari daging babi,” tambahnya.

Terhadap para jemaah haji yang telah menggunakan vaksin meningitis yang mengandung enzim babi tersebut, Ketua MUI Sumsel menjelaskan, masuknya zat haram ke dalam tubuh para calon jemaah haji  itu berakibat menghalangi kemabruran hajinya. Sebab syarat mabrurnya haji, selain bersih secara jiwa, para jamaah haji juga harus bersih secara raga.

“Kalau tubuh kita kemasukan zat yang diharamkan maka dapat menghalangi terkabulnya doa. Tapi bagi mereka yang tidak tahu bisa dimaafkan, yang berdosa adalah orang yang mengambil kebijakan dan mengetahui hal itu tapi tetap dilaksanakan,” tegasnya./oed/itz

CEGAH PENYAKIT DEGENERATIF DENGAN GANGGANG

CEGAH PENYAKIT DEGENERATIF DENGAN GANGGANG
By Republika Newsroom
Rabu, 23 Juli 2008 pukul 15:20:00

Cegah Penyakit Degeneratif dengan Ganggang

Penyakit degeneratif (penuaan dini), baik kronis maupun tidak, selama ini sering dijumpai menimpa masyarakat modern. Ini akibat sebagian orang tidak merawat tubuh dengan baik dan pola hidup yang tidak sehat. Misalnya, kebiasaan merokok, minum-minuman beralkohol, kurang olah raga, kurang istirahat, stres, makan kurang proporsional, dan pencemaran lingkungan.

Tak ada obat medis yang bisa menyembuhkan penyakit ini secara ilmiah. Namun, penyakit degeneratif nyatanya bisa diminimalisasi dengan Cryptomonadales, sejenis ganggang yang hidup di air tawar bersih dan memiliki kandungan nutrisi lengkap untuk membantu meregenerasi sel-sel yang telah rusak.

Ganggang (algae) Cryptomonadales ditemukan oleh Wang Shun Tee, seorang dosen biodemikal dan guru besar di Ping Tung Technology University Taiwan. Ia telah melakukan riset selama 30 tahun sebelum akhirnya menemukan ganggang tersebut. ”Cryptomonadales adalah ganggang berbentuk elips yang merupakan produk baru yang dikembangkan melalui proses bioteknologi,” ungkap Wang Shun Tee.

Menurut Wang Shun Tee, Cryptomonadales adalah spesies dengan mutu terbaik dari jenis Chlorella sorokiniana. Cryptomonadales, lanjut dia, adalah ganggang (algae) berbentuk elips yang merupakan produk baru hasil penelitian dan pengembangan dari dua jenis ganggang unggul, yakni Chlorella dan Spirulina.

Dia mengaku mengembangbiakkan sendiri Cyptomonadales dengan prosedur, perawatan, dan seleksi yang sangat ketat. ”Cryptomonadales tumbuh sangat cepat, bibit yang stabil, dengan membran sel yang tipis, dan mengandung Cryptomonadales Growth Factor (CGF) yang tinggi, vitamin, dan elemen-elemen langka lainnya,” jelasnya.Cryptomonadales, kata Wang, memerlukan energi solar untuk membawa proses fotosintesis. Artinya, hanya memerlukan udara, air, dan matahari.

Penambahan produksi dari Cryptomonadales di setiap generasi, lanjut dia, dari satu sel dapat menjadi empat dalam waktu 24 jam. ”Perkembangannya cepat sekali dibanding buah atau sayuran yang butuh empat hingga enam bulan untuk panen. Dengan populasi penduduk di dunia yang terus bertambah, ini bakal membantu karena produksinya cepat,” tegasnya.

Wang yang juga direktur utama Chlorella International kemudian mendapat dukungan penuh Departemen Kesehatan Taiwan melalui serangkaian penelitian yang diketuai Prof Ih-Jen Su PhD, alumnus Harvard Medical School USA, serta Dr Chun Chian Yu dari Departemen Mikrobiologi dan Imunologi, dan Prof Shi Dan Jan dari Departemen Bioteknologi, Cheng Kung University, Taiwan. Dari riset itu lahirlah tablet, bubuk, dan ekstrak cairan Cryptomonadales yang sangat cepat diserap tubuh. Selain itu, dalam riset medis juga telah membuktikan bahwa Cryptomonadales mengandung konsentrasi yang tinggi dari asam lemak tak jenuh berkualitas tinggi dan aktivator PPAR (Peroxisome Proliferator Activated Receptors, Micro Lipid Activating Receptor, atau Chlorella Lipid Substance). `’Cryptomonadales juga mengandung konsentrasi protein, karbohidrat, dan asam lemak tak jenuh yang tinggi,” ujar Wang. (eye/rin)

Vaksin dari Janin Bayi

http://www.halalguide.info/content/view/803/

Vaksin dari Janin Bayi

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Wednesday, 31 January 2007

ImageHalalGuide–Penggunaan janin bayi yang sengaja digugurkan ini bukan merupakan suat hal yang dirahasiakan publik. Sel line janin yang biasa digunakan untuk keperluan vaksin biasanya diambil dari bagian tubuh seperti paru-paru, kulit, otot, ginjal, hati, thyroid, thymus, dan hati yang diperoleh dari aborsi janin.

Vaksin untuk cacar air, hepatitis A, dan MMR diperoleh dengan menggunakan fetal cell line yang diaborsi, MRC-5, dan WI-38. Vaksin yang mengandung MRC-5 dan WI-38 adalah beberapa vaksin yang mengandung cell line lipoid manusia.

Tabel di bawah ini menunjukkan jenis vaksin yang diperoleh dari praktik aborsi:

Penyakit

Vaksin

Produsen

Sel Line (human fetal)

Polio

Poliovax

Aventis-Pasteur

MRC-5

Measles Mumps Rubella

MMR II

Merck & Co

RA273 & WI38

Meales-Rubella

Biavax II

Merck & Co

RA273 & WI38

Rubella Only

MR-VAX

Merck & Co

RA273 & WI38

Rabies

Imovax

Aventis-Pasteur

MRC-5

Hepatitis A

Hivrax

Vagta

Glaxo Smith Kline

Merck & Co

MRC-5

Hepatitis A-B combo

Twinnix

Glaxo Smith Kline

MRC-5

Chickenpox

Varixax

Merck & Co

WI 38 & MRC-5

Smallpox

Acambix 1000

Acambis

MRC-5

Ebola

Unknown

Merck & Co

PER C6

HIV

Unknown

Merck & Co

PER C6

Sepsis

Xigris

Eli Lilley

HEK 293

Influenza

Unknown

Medimmune

PER C6

Sumber Jurnal Halal LPPOM MUI

Penanganan Flu Burung Ala Thailand

http://www.bainfokomsumut.go.id/open.php?id=10&db=h5n1

Senin, 24 Jul 2006

Penanganan Flu Burung Ala Thailand

alam sebuah simposium internasional tentang penanganan dan pencegahan merebaknya flu burung, yang digelar di Jakarta pada 13-14 Juli 2006, turut hadir pakar dari beberapa negara tetangga, termasuk dari Thailand.

Somsak Pakpinyo, seorang sarjana S3 Universitas Chulalongkorn, berbicara sebagai wakil dari Thailand dan mempresentasikan kebijakan negerinya menangani flu burung.

Hal yang menarik dari pemaparan Somsak adalah kebijakan Thailand yang melarang penggunaan metode vaksinasi unggas dan ayam ternak dalam upaya pencegahan penyebaran flu burung.

Somsak menyebutkan bahwa Pemerintah Thailand tidak menggunakan metode vaksinasi sebagai upaya pencegahan penyebaran flu burung dalam industri peternakan, sejak awal penyakit itu beredar di negeri itu.

Bagaimana dengan Indonesia?

Tri Satya Naipospos, dari Komisi Nasional Flu Burung, menyebutkan bahwa Indonesia justru menerapkan kebijakan vaksinasi sebagai pelengkap metode biosecurity yang ditempatkan sebagai lini terdepan.

Strategi Thailand

Selama Januari 2004 hingga Januari 2005, industri peternakan Thailand terganggu virus flu burung. Virus yang bersirkulasi pada saat itu dikategorikan sebagai Avian Influenza jenis H5N1 yang patogenik.

Penanganan pun dilakukan secara serius, terlihat dari reaksi cepat perdana menteri dan departemen-departemen terkait yang menyusun strategi nasional.

Sebagai “panglima” pencegahan merebaknya virus, kata Somsak, Departemen Pengembangan Pangan bertanggungjawab dalam hal pengendalian virus di sektor peternakan, termasuk ternak ayam, ayam piaraan di kandang-kandang belakang rumah, bebek, dan angsa.

“Setelah mempertimbangkan keuntungan dan kerugian vaksinasi AI, pemerintah berkeputusan untuk melarang vaksinasi dalam industri peternakan,” kata dia.

Memang, vaksinasi merupakan salah satu cara untuk menangkal penyebaran virus AI. Organisasi Pertanian Dunia (FAO) menyarankannya sebagai pendamping biosecurity, pendidikan pengenalan AI, dan kesadaran masyarakat.

Selain berfungsi untuk menekan penyebaran virus, terbukti metode vaksinasi “ampuh” mengendalikan epidemi flu burung di Cina.

Namun vaksinasi AI tidak menyelesaikan masalah. Vaksinasi merugikan sektor ekonomi karena bertentangan dengan regulasi IOE dan Uni Eropa karena satu persen dari hewan yang divaksinasi dapat tetap menularkan virus tanpa menunjukkan gejala-gejala klinis.

Itu sebabnya vaksinasi disebut-sebut menghadirkan “pembunuh diam-diam”, karena daya tahan virus justru meningkat, mutasi bisa terjadi setiap waktu, dan hanya 20-50 persen vaksin burung yang beredar di pasar yang membawa anti-bodi H5N1.

“Strategi kedua yang diterapkan di negeri Gajah Putih adalah pemantauan aktif secara klinis terhadap industri peternakan,” kata Somsak.

Sistem pemantauan di Thailand menyebutkan bahwa kriteria suspek kasus AI adalah bila kematian unggas mencapai 10 persen atau lebih dan 40 persen dalam tiga hari.

Pemusnahan dilakukan dalam radius 5 km dari titik kasus penyebaran, dengan harga ganti rugi minimal 70 persen harga pasar.

“Tapi untuk ayam petarung, tidak langsung dimusnahkan tapi diungsikan ke tempat lain untuk kemudian diamati lebih cermat,” ujar dia.

Khusus tentang uang ganti-rugi, Pemerintah Thailand menetapkan angka 70 persen dari harga pasar adalah angka yang dianggap cukup masuk akal karena setelah isu flu burung merebak, daya beli masyarakat terhadap panganan unggas menurun drastis, termasuk daging dan telur ayam.

Pemusnahan massal terhadap unggas yang terpapar dan dicurigai terpapar flu burung pun dilakukan dalam tempo tak lebih dari 24 jam sejak hasil uji klinis menunjukkan adanya penularan virus tersebut.

Dalam hal reaksi terhadap penularan antar-ternak, sistem pengawasan sangat lekat terhadap pergerakan hewan dari satu tempat ke tempat lain.

“Strategi ini diterapkan oleh polisi, petugas pangan, peternak, dan rumah jagal. Kerja sama di antara mereka adalah kunci keberhasilan pemantauan virus,” masih kata Somsak.

Strategi Thailand juga terletak di tindakan pencegahan. Peternakan unggas ditingkatkan standarnya, sesuai dengan biosecurity, tingkat higienitas, dan pengawasan dokter hewan.

Di Thailand, terdapat sekitar 50 ribu peternakan unggas, terdiri atas yang kecil dan besar. Pemerintah tentu tidak mampu menyelidiki tiap peternakan, itu sebabnya peran perguruan tinggi seperti Universitas Chulalongkorn dapat sangat membantu.

Biaya Pemusnahan

Dalam kesempatan yang sama, Tri Satya menyebutkan bahwa Pemerintah Indonesia menjadikan vaksinasi sebagai metode penanganan setelah menghitung biaya pemusnahan massal hewan yang ditengarai terpapar virus sangatlah besar.

“Dana penanganan flu burung saja sampai saat ini belum ada yang cair, kita sangat kekurangan dana memerangi flu burung,” kata dia.

Thailand, menurut Tri Satya, sangat peduli terhadap penanganan flu burung karena industri peternakan di dalam negeri memang sangat rentan — berbeda dengan Indonesia.

“Pangsa pasar produk peternakan unggas Thailand 60 persennya adalah untuk negeri-negeri Eropa, yang peraturannya melarang ternak tervaksin. Sementara di Indonesia, industri peternakan hanya memenuhi kebutuhan dalam negeri yang sudah sangat besar,” kata dia.

Di lain pihak, pilihan vaksinasi kurang disukai oleh kalangan pecinta unggas.

Sekretaris Umum Pelestari Burung Indonesia, Endang Budi Utami, menyebutkan bahwa biaya penanganan flu burung dengan cara vaksinasi jauh lebih mahal daripada pemusnahan (stamping-out).

“Pertama, vaksinasi tidak bisa digunakan hanya satu kali, melainkan berkali-kali dan harus terus dilakukan selama hewan itu hidup,” kata perempuan yang akrab disapa Emi tersebut.

Alasan kedua adalah vaksinasi sulit dilakukan terhadap burung-burung liar dan besar, sementara banyak koleksi para pecinta burung yang berupa burung liar dan berukuran besar.

“Saya juga yakin bahwa vaksinasi itu tidak dapat membunuh semua virus di dalam tubuh hewan, ada saja yang tersisa dan ini justru membawa celaka nantinya karena virus bisa lebih mutan,” jelasnya.

Pilihan stamping-out seperti tindakan Thailand atau vaksinasi adalah hal yang sama-sama mengandung resiko. Namun ibarat membeli mobil baru, setiap orang dapat saja dihadapkan dengan pilihan membelinya dengan cara kredit atau tunai.

Membeli tunai memang terasa berat di awal, namun mobil dibawa pulang tanpa rasa tergelayut utang.

Sementara membeli dengan cara berutang, sama-sama membawa pulang mobil baru, namun yang satu ini harus ditambah dengan cicilan serta kewajiban membayar bunga — yang pada akhirnya dapat membuat harga mobil nyaris setara dengan dua mobil baru bila dibeli tunai.

Pemerintah Indonesia bisa jadi kesulitan bila harus menyediakan sejumlah uang tunai yang besar pada metode stamping-out, namun hampir dapat dipastikan semua virus berakhir di situ.

Metode vaksinasi memungkinkan pengendalian penyebaran virus, tetapi tak ada jaminan virus berhenti berkembang sehingga bukan tidak mungkin biaya ekonomi pada masa mendatang bisa jauh lebih mahal daripada stamping-out. (Ant)

Vaksin BCG menyebabkan penyakit dan kematian pada bayi HIV-positif Oleh: The Kaiser Daily HIV/AIDS Report

http://spiritia.or.id/news/bacanews.php?nwno=0511

Vaksin BCG menyebabkan penyakit dan kematian pada bayi HIV-positif
Oleh: The Kaiser Daily HIV/AIDS Report

Tgl. laporan: 6 November 2007

Vaksin BCG, yang ditujukan untuk mencegah tuberkulosis (TB) pada anak di negara berkembang, dapat menyebabkan penyakit dan kematian di antara beberapa bayi HIV-positif. Hal ini dikatakan para peneliti dalam surat kabar Los Angeles Times. Temuan ini tercakup dalam laporan tentang koepidemi HIV/TB yang diterbitkan oleh Forum for Collaborative HIV Research pada 1 November 2007. Laporan ini mengatakan bahwa “manfaat yang berpotensi mencegah TB berat” pada bayi HIV-positif adalah “risiko terkait lebih kecil dibandingkan dengan penggunaan vaksin BCG.”

WHO menyarankan agar semua bayi yang sehat harus menerima vaksin BCG segera setelah lahir. Tetapi, lembaga ini mengeluarkan laporan pada Mei 2007, yang mengubah pendapatnya karena bukti menunjukkan bahwa bayi HIV-positif lebih berisiko mengembangkan penyakit BCG. Vaksin BCG berdasarkan pada rangkaian bakteri penyebab TB yang dilemahkan, yang ditemukan pada ternak. Banyak bayi yang menerima vaksin BCG ini adalah HIV-positif saat lahir dan oleh karena itu mempunyai sistem kekebalan tubuh yang lemah. Hal ini mengakibatkan mereka rentan terhadap penyakit BCG, yang disebabkan oleh bakteri sapi ini yang ada pada vaksin.

Sebuah penelitian menemukan bahwa vaksin tersebut memiliki 75% tingkat mortalitas di antara anak dengan penyakit BCG dan 70% anak tersebut adalah HIV-positif. Hal ini dikatakan oleh Mark Cotton – rekan penulis laporan forum dan para peneliti HIV/AIDS di Universitas Stellenbosch Afrika Selatan.

Menurut Cotton, diperkirakan 400 dari setiap 100.000 bayi HIV-positif di provinsi Western Cape, Afrika Selatan menjadi sakit akibat vaksin BCG, dan belum diketahui seberapa besar masalah ini di seluruh Afrika.

Inilah Produk yang Mengandung Melamin di Indonesia!

Inilah Produk yang Mengandung Melamin di Indonesia!
Inilah produk-produk yang mengandung susu asal Cina, dan positif terdapat campuran melamin didalamnya.

Sabtu, 27 September 2008 | 13:58 WIB

Laporan wartawan Kompas.com Inggried Dwi Wedhaswary

JAKARTA, SABTU — Departemen Kesehatan mengeluarkan rilis terbaru terhadap hasil pemeriksaan produk asal China yang mengandung susu dan diindikasi tercampur melamin. Dari 19 produk impor asal China yang mengandung susu, hanya ditemukan enam produk yang terdapat di sarana distribusi/pasar di Indonesia.

Keenam produk tersebut adalah;

– Guozhen (susu bubuk full cream, dipasarkan lewat MLM)

– Oreo Wafer Stick (hanya yang buatan China. Produk buatan Indonesia aman),

– M & M’s (kembang gula, bungkus kuning dan bungkus coklat),

– Snickers (biskuit),

– White Rabbit (kembang gula, kemasan merah & hijau)

Soybean Drink with Milk (kemasan hijau dan kuning, termasuk Soyspring Instant Milk Cereal dan Soyspring Instant Peanut Milk).

Lima produk pertama, terdaftar di Badan POM. Akan tetapi, satu produk terakhir, yaitu Soybean Drink, merupakan produk impor ilegal.

Dalam jumpa pers di Gedung Departemen Kesehatan, Sabtu (27/9) siang, Menteri Kesehatan Siti Fadilah Supari memaparkan, keseluruhan sampel produk impor asal China ditemukan positif mengandung melamin dengan kadar melamin berkisar 8,51 mg per kg (ppm) sampai 945,86 mg per kg (ppm).

“Terhadap produk yang mengandung melamin tersebut akan segera dilakukan pemusnahan,” kata Siti.

Di luar enam produk itu, ada 16 produk lain asal China yang tidak ditemukan di pasar. Produk itu adalah Jinwei Yougoo, Meiji Indoeskrim Gold Monas, Oreo Chocolate Sandwich Cookie, Dove Choc, Merry X-Mas (kembang gula), Penguin (kembang gula), Nestle Nesvita Materna (makanan ibu hamil dan menyusui) dan Nestle Milkmaid (selai susu).

Masyarakat yang menemukan produk-produk diatas di pasaran diminta melaporkan ke Unit Layanan Pengaduan Konsumen (ULPK) Badan POM dengan telepon (021) 4263333/32199000 atau SMS ke 081511997772.

Strategi Kaum Pagan Menuju The New World Order

Strategi Kaum Pagan Menuju The New World Order

http://www.eramuslim.com/berita/tahukah-anda/strategi-kaum-pagan-menuju-the-new-world-order-bag-6.htm

Kamis, 18 Sep 2008 08:19 Kini tutuplah mata kita, dan begitu kita buka kembali, hilangkan semua persepsi dan paradigma yang ada. Kita akan bisa melihat dengan jelas jika kini berbagai upaya menghabisi ras manusia tengah terjadi di depan dan sekeliling kita.

Berbagai penyakit baru terus bermunculan menghinggapi manusia dan parahnya belum ditemukan obat yang paten yang mampu menyembuhkan secara total, seperti halnya virus HIV, dan juga Virus H5N1 dalam kasus Flu Burung. Kita tentu ingat, setiap kali ada korban meninggal akibat virus ini, media massa baik cetak maupun elektronik senantiasa menyebutnya sebagai ‘Suspect Flu Burung’ alias baru diduga, bukan dipastikan.

Di lain sisi, obat-obatan kimiawi yang diproduksi oleh dunia medis dan direkomendir oleh para dokter ternyata juga tidak bebas dari efek samping. Obat untuk sesuatu penyakit ternyata jika digunakan secara kontinyu akan menimbulkan penyakit lain. Penyakit utama yang diderita pun bisa jadi bertambah kuat dan sebab itu membutuhkan dosis dari obat yang sama yang lebih besar lagi agar penyakit atau virus atau kuman yang lebih kuat bisa dibasmi.

Parahnya, aneka bahan konsumsi manusia yang berasal dari alam pun ternyata dewasa ini sudah jauh dari nilai sehat. Sayuran dan buah-buahan misalnya, dalam perawatannya selalu disemprot dengan herbisida atau insektisida yang tidak aman bagi manusia. Belum lagi zat pengawet yang biasa diberikan kepada sayuran dan buah-buahan impor agar lebih tahan lama dan tidak mudah busuk, juga menambah daftar zat kimia berbahaya yang dipastikan akan ikut masuk ke dalam tubuh manusia jika dikonsumsi. Lama-kelamaan, zat-zat yang jumlahnya mungkin sangat kecil ini, bisa menjadi besar karena mengendap di dalam tubuh dan menjadi bibit penyakit.

Satu contoh, seorang perempuan yang sejak muda sering mengkonsumsi mie instan atau penganan pabrik yang mengandung Mono Sodium Glutamat (MSG) alias bahan penyedap atau penguat rasa yang lazim ditambahkan ke dalam banyak sekali penganan produk pabrik, lima sampai sepuluh tahun ke depan pasti akan tumbuh kista di dalam tubuhnya yang bisa jadi bertambah ganas menjadi tumor. Banyak sekali kasus ini di dunia dan juga di Indonesia.

Ironisnya, penggunaan MSG oleh media massa malah dipromosikan secara besar-besaran sebagai zat yang mampu mendongkrak rasa dan kenikmatan sebuah makanan, namun tidak dipaparkan secara jujur efek samping membahayakan bagi tubuh manusia. Berbagai penelitian dari dunia medis tentang bahaya MSG pun tidak disosialisasikan secara massal. Akibatnya, hanya orang-orang tertentu yang care terhadap kesehatan-lah yang berusaha sekuat tenaga menghindari penggunaan zat aditif tersebut. Sedangkan kalangan bawah yang tertutup akses informasi (karena buku atau pendidikan mahal harganya), dan kelompok ini jauh lebih besar kuantitasnya, tidak mengetahui akan bahaya tersebut dan terus-menertus mengkonsumsi penganan yang tidak sehat tersebut. Akibatnya, berbagai penyakit mereka derita dan biasanya kematian selalu menjadi akhir dari cerita mereka karena untuk berobat ke dokter pun mereka tidak memiliki cukup uang.

Satu contoh lagi tentang zat aditif. Tahukah Anda jika setiap ayam goreng yang disajikan oleh berbagai resto fasfood ternama dunia merupakan ayam yang dari telur hingga dewasa dan dipotong, masa hidupnya tidak sampai dua bulan? Ayam tersebut besar dengan cepat disebabkan suntikan hormon yang diberikan secara berkala dengan jumlah yang besar. Hormon tersebut tidaklah hilang tatkala ayam tersebut digoreng. Hormon itu tetap ada dan masuk ke dalam perut kita saat kita menyantapnya. Inilah penjelasan mengapa anak-anak remaja sekarang banyak yang menderita obesitas dan berbagai macam penyakit. Jika masih ragu, tontonlah film semi dokumenter yang cukup menghibur berjudul ‘Super Size Me’ yang disutradarai Morgan Spurlock dari AS.

Coba sekarang tutup mata kita, dan begitu kita buka kembali, hilangkan semua persepsi dan paradigma yang ada. Kita akan bisa melihat dengan jelas jika sekarang ini berbagai upaya menghabisi ras manusia tengah terjadi di depan dan sekeliling kita, lewat peperangan, propaganda media massa, hegemoni ekonomi, penyakit, konflik, makanan, dan bahkan obat-obatan. Apakah ini berjalan dengan sendirinya? Tentu sangat naif jika kita mengira demikian.

Fluoride

Zat kimia ini secara umum dipersepsikan orang sebagai zat ampuh untuk memperkuat tulang gigi. Sebab itu, zat ini banyak disisipkan di dalam pasta gigi. Bahkan 66% cadangan air minum warga AS telah dicampuri zat ini secara sengaja. Benarkah fluoride berguna?

Jawaban yang ada mungkin akan mengejutkan kita semua. Fluoride telah diteliti banyak pakar kesehatan dan ternyata ditegaskan mengandung bahan berbahaya bagi tubuh. Antara lain bisa menyebabkan kanker tulang, oestoporosis, masalah persendian, turunnya kadar testoteron dan estrogen, dan sanggup mengkorosi lapisan enamel gigi. Bahkan dikatakan jika fluoride lebih merusak gigi ketimbang garam.

Sekarang, pergilah ke toko atau super market yang ada. Carilah racun tikus. Dan lihatlah, apa bahan utama pembuat racun tikus? Yakni Sodium Fluoride. Ini adalah zat kimia ionik yang paling beracun setelah Potasium Dikromat. Saat ini, perusahaan-perusahaan besar yang bergerak dalam bisnis air minum dalam kemasan diketahui telah memasukkan fluoride ke dalam produk air minum dalam kemasan mereka. Hal ini dilakukan tanpa membubuhkan keterangan sedikit pun dalam label kemasannya.

Dunia medis juga telah mengetahui jika fluoride juga digunakan sebagai obat anti depresan, yang menghilangkan agresifitas dan motivasi manusia, termasuk menurunkan hasrat untuk berkembang-biak. “Fluoride memang tidak memiliki faktor yang menguntungkan secara biologis, ” tegas Dr. Rima Laibaow dari Natural Solutions Foundation.

MPOWER dan Rokok

IPTEK
MPOWER dan Rokok
Rabu, 3 September 2008 | 03:00 WIB

IRWAN JULIANTO

Tanggal 12 Mei 1994, sebuah paket berisi 4.000 halaman dokumen internal rahasia industri rokok tiba di kantor Prof Stanton Glantz di Institut Pengkajian Kebijakan Kesehatan Departemen Kedokteran Universitas California, San Francisco. Pengirimnya anonim.

Dokumen yang dikirim itu ternyata amat mengejutkan karena membeberkan aktivitas dan kebohongan publik perusahaan rokok Brown & Williamson, anak perusahaan British American Tobacco (BAT). Tahun 1996, Prof Glantz dan timnya memublikasikan buku The Cigarette Papers, yang menawarkan intipan lewat lubang kunci bagaimana industri rokok bekerja. Buku ini tidak hanya mengubah secara mendasar persepsi masyarakat Amerika Serikat tentang industri rokok dan bagaimana mengubah kebijakan publik untuk meregulasi dan melitigasi industri rokok.

Pada dekade 1980-an industri rokok sudah terpojok ketika Surgeon General dijabat C Everett Koop pada 1981-1989, yang dengan laporannya Nicotine Addiction (1988) menyatakan nikotin adalah bahan aktif yang menimbulkan kecanduan mirip heroin dan kokain. Koop makin membuat industri rokok kelabakan dengan tudingan ”perokok pasif” yang disebabkan asap lingkungan tembakau (environmental tobacco smoke/ETS) terancam kanker paru.

Menurut Koop dalam pengantar buku The Cigarette Papers, buku itu memastikan bahwa para ilmuwan dan eksekutif perusahaan rokok B&W dan BAT sejak awal 1960-an sudah tahu sifat dan efek biologis nikotin, bahkan mengeksploitasinya untuk membuat para perokok makin kecanduan. ”Buku ini adalah senjata vital untuk perang melawan rokok,” tulisnya.

Indonesia patut malu

Bagai gelindingan bola salju, dokumen-dokumen rahasia B&W dan enam perusahaan rokok AS lainnya tahun 1998 diperintahkan oleh pengadilan untuk diungkapkan kepada umum. Demikian Mardiyah Chamim, wartawati Tempo dalam buku Kemunafikan dan Mitos di Balik Kedigdayaan-Penelusuran Dokumen Industri Rokok (2007). Di antaranya terdapat memo internal PT BAT Indonesia tentang upaya melobi pejabat, legislator, ilmuwan, hingga wartawan.

Acara ”Media Briefing on Smoking Issues” bulan September 1992 di Nusa Dua, Bali, yang dihadiri wartawan Asia Pasifik adalah salah satu contoh kegiatan untuk menyatakan bahwa rokok tidak seberbahaya yang digembar-gemborkan media AS. Liputan Kompas (13/9/1992) berjudul ”Industri Rokok Mulai Lancarkan Kampanye Tandingan” dipelintir dengan terjemahan ”Cigarette Industries Begin to Launch Equal Campaign” dilaporkan dalam salah satu memo laporan Humas BAT Indonesia kepada markas besarnya. Jika tak hati-hati membaca dokumen semacam ini, bisa ditafsirkan bahwa semua wartawan sudah ”terbeli” oleh industri rokok.

Liputan Kompas (31/8) tentang kehidupan petani tembakau di Temanggung yang mempersoalkan upaya Komnas Perlindungan Anak meminta MUI mengeluarkan fatwa haram bagi rokok juga telah disalahpahami sebagai tidak mendukung kampanye antirokok. Seorang guru besar ilmu politik yang belakangan menjadi aktivis antirokok mengirimkan >small 2<sms>small 0< ke mana- mana karena liputan Kompas itu.

Ada lagi beberapa LSM, termasuk YLKI, yang melakukan litigasi kepada Presiden dan DPR yang hingga kini belum menandatangani dan meratifikasi Kerangka Kerja Konvensi Pengendalian Tembakau (Framework Convention on Tobacco Control/FCTC), padahal 168 negara lain sudah melakukannya. FCTC yang disepakati dalam Dewan Kesehatan Dunia (WHA) tahun 2003 merupakan traktat internasional pengendalian tembakau.

Pada masa pemerintahan Presiden Megawati Soekarnoputri, Menkes Achmad Sujudi berkali-kali mengusulkan agar Indonesia mendukung FCTC, tetapi ditentang oleh menteri-menteri yang membidangi pertanian, tenaga kerja, industri, dan keuangan. Tak jelas bagaimana upaya Menkes Siti Fadilah Supari empat tahun terakhir, tetapi yang jelas Indonesia patut malu karena dinilai dunia tidak serius mengendalikan rokok sehingga posisinya sejajar dengan negara-negara gurem, seperti Andorra, Eritrea, dan Guinea Bissau.

Padahal, Dirjen WHO Margaret Chan dalam buku WHO Report on the Global Tobacco Epidemic, 2008 mengingatkan, pada abad ke-20, epidemi tembakau telah membunuh 100 juta penduduk dunia dan pada abad ke-21 ini jika tak ada upaya serius dapat membunuh 1 miliar orang! Tahun ini diperkirakan ada 5,4 juta kematian akibat rokok, lebih banyak dibandingkan gabungan kematian akibat TBC, HIV/AIDS, dan malaria. Menurut Suwarta Kosen (2007), biaya kesehatan akibat rokok yang dikeluarkan Indonesia pada tahun 2006 sebesar 18,1 miliar dollar AS atau sekitar 5,1 kali pendapatan negara dari cukai tembakau pada tahun yang sama.

Sayang sekali, kegiatan kampanye antirokok di Indonesia berjalan sendiri-sendiri dan tidak terkoordinasi/bersinergi. Seyogianya pemerintah dan masyarakat menggunakan strategi pengendalian dampak tembakau yang dilancarkan WHO tahun ini, yaitu enam kebijakan disingkat MPOWER: (M)onitor penggunaan tembakau dan kebijakan pencegahannya; (P)erlindungan terhadap asap rokok; (O)ptimalkan dukungan untuk berhenti merokok; (W)aspadakan masyarakat akan bahaya tembakau; (E)liminasi iklan, promosi dan sponsor rokok; (R)aih kenaikan cukai rokok.

Pengendalian epidemi akibat merokok memang tak cukup hanya dengan upaya mengharamkan rokok yang malah kontroversial dan tak produktif. Iklan rokok harus ditandingi dengan iklan layanan masyarakat dan ”gerilya media” yang cerdas dengan biaya murah, yang terbukti efektif, seperti dilakukan Tony Schwartz di AS. Juga tak cukup dengan desakan kenaikan cukai rokok atau perda larangan merokok di tempat umum, yang di Jakarta ternyata cuma jadi ”macan kertas”.

Enam Orang Tewas Setelah Diberi Antibodi

Enam Orang Tewas Setelah Diberi Antibodi
Senin, 2 Juni 2008 – 13:04 wib
Ahmad Dani – Okezone

BEIJING – Enam orang dilaporkan tewas setelah disuntik antibodi di sebuah rumah sakit Universitas di China. Kasus terakhir yang sama, korban tewas akibat kesalahan dari obat-obatan tersebut.

“Enam orang tewas antara 22 hingga 28 Mei setelah diberikan antibodi berupa imunisasi globulin,” kata, Yu, jurubicara di RS Universitas Nanchang di Provinsi Jiangxi, seperti dikutip Associated Press, Senin (2/6/2008).

Pihak rumah sakit mengaku akan meminta pertanggungjawaban dari produsen obat tersebut. Namun sayang, mereka menolak untuk memberitahukan siapa produsen obat yang mengakibatkan enam orang tewas itu.

Sementara itu Jurubicara Badan Pengawas Obat dan Makanan, Huang Fu membenarkan ada enam orang yang tewas tersebut. Tapi, saat ini pihaknya sedang melakukan investigasi dan membawa contoh obat untuk dilakukan penelitian.

Glubolin adalah antibodi yang diberikan untuk melawan penyakit seperti Hepatitis A dan gigitan anjing seperti rabies. (ahm)

Boom! Autisme Terus Meningkat

Boom! Autisme Terus Meningkat

http://www.kompas.com/read/xml/2008/06/08/1739470/boom.autisme.terus.meningkat

Minggu, 8 Juni 2008 | 17:39 WIB

Oleh : Elok Dyah Messwati dan Evy Rachmawati

PERKEMBANGAN autisme yang terjadi sekarang ini kian mengkhawatirkan. Mulai dari tahun 1990-an, terjadi boom autisme. Anak-anak yang mengalami gangguan autistik makin bertambah dari tahun ke tahun.

Di Amerika Serikat saat ini perbandingan antara anak normal dan autis 1:150, di Inggris 1:100, sementara Indonesia belum punya data tentang itu. Belum pernah ada survei mengenai data anak autis di Indonesia, kata Ketua Yayasan Autisme Indonesia dr Melly Budhiman SpKJ saat diskusi mengenai autisme di harian Kompas, 5 Mei 2008.

Melly Budhiman memaparkan, autisme adalah suatu gangguan neurobiologis yang terjadi pada anak di bawah umur 3 tahun. Gejala yang tampak adalah gangguan dalam bidang perkembangan: perkembangan interaksi dua arah, perkembangan interaksi timbal balik, dan perkembangan perilaku.

Autisme bisa terjadi kepada siapa saja, tidak mengenal etnis, bangsa, keadaan sosial ekonomi, dan keadaan intelektualitas orangtua. Perbandingan antara anak laki-laki dan perempuan yang mengalami gangguan autistik adalah 4:1. Kecerdasan anak-anak autis sangat bervariasi, dari yang sangat cerdas sampai yang sangat kurang cerdas.

”Jadi kalau dulu dikatakan kalau anak autis pasti anak-anak cerdas itu tidak benar, atau anak autis itu kebanyakan retardasi mental itu juga tidak benar,” kata Melly Budhiman.

Diagnosa ditegakkan secara murni secara klinis tanpa dengan alat pemeriksaan atau bantuan apa pun. ”Jadi kalau kita mendiagnosa anak autis murni secara klinis dengan anamnese, dengan tanya jawab itu harus sangat cermat: mulai dari kehamilan, kelahiran, dan masa kecilnya,” kata Melly Budhiman.

Sebelum 3 tahun

Untuk bisa melakukan diagnosa yang tepat, tentu saja dibutuhkan ketajaman dan pengalaman klinis. Harus benar-benar diperhatikan kriteria diagnostik yang sudah disepakati oleh Badan Kesehatan Dunia (WHO). Jadi untuk mendiagnosa autis itu sudah ada kriterianya.

”Apakah ada gangguan dalam bidang komunikasi, interaksi, juga perilaku. Kriterianya sebenarnya sudah jelas,” tegas Melly Budhiman.

Menurut Melly Budhiman, diagnosa itu harus sudah ditegakkan sebelum anak mencapai usia tiga tahun. Sering kali orangtua datang ke dokter dan dokter menyatakan sebaiknya menunggu hingga usia anak sudah tiga tahun, itu artinya sudah terlambat.

Sebelum tiga tahun diagnosa sudah harus ditegakkan. Deteksi dari permulaan gejala sudah bisa dilakukan jauh sebelum umur tiga tahun. Ada anak yang sudah menunjukkan gejala autisme sejak lahir, tetapi ada anak yang sudah berkembang secara normal namun kemudian berhenti berkembang, kehilangan kepandaian yang telah dicapainya dan timbul gejala-gejala autisme.

”Bila terdeteksi adanya gejala autisme pada umur berapa pun, mulailah dengan melakukan interaksi yang intensif dan pantau terus anak tersebut setiap bulan. Misalkan enam bulan, kok, anak ini tidak mau menatap mata, umur tujuh bulan juga harus terus dipantau,” kata Melly Budhiman.

Dalam hal ini semua pemeriksaan adalah untuk mencari kemungkinan pencetus. Jika si ibu waktu hamil mengalami rubela, maka sebaiknya dilakukan city scan MRI, mencarinya ke arah otak apakah ada kelainan. Jika seandainya waktu lahir si anak terlilit tali pusar sehingga kekurangan O2, bisa dilakukan MRI dan kemudian EEG.

”Jika ibu menyatakan kalau setelah divaksinasi, kondisi si anak kemudian makin mundur, kita cari apakah anak ini keracunan merkuri. Darahnya harus diperiksa untuk mencari tahu berapa kadar logam berat, logam merkuri, diperiksa rambutnya, apakah merkurinya sudah lama menumpuk di tubuh dan tidak bisa keluar, misalnya,” papar Melly Budhiman.

Setelah anak terdiagnosa, langkah berikutnya adalah melakukan assessment yang dilakukan oleh satu tim psikolog, speech therapist untuk menentukan kemampuan si anak sebenarnya di bidang apa.

”Misalnya speech-nya terbelakang, tetapi keseimbangannya bagus, bisa lari, bisa lompat. Jadi lebih penting ke speech therapy. Jika perilakunya enggak karuan, maka diberi terapi perilaku,” kata Melly Budhiman.

Terapi okupasi juga bisa diberikan untuk melatih motorik halus. ”Anak-anak ini biasanya tenaganya kuat. Jika memukul orang bisa keras sekali, tetapi kalau disuruh memegang pensil tidak bisa, maka dia perlu terapi okupasi,” kata Melly Budhiman. Yang terpenting penanganan terpadu harus diberikan kepada anak-anak autis ini.

Kecurigaan pada vaksin

Sejauh ini, belum diketahui pasti penyebab autisme. Namun, faktor genetik berperan penting pada tercetusnya gejala. Bila tidak ada kelemahan genetik, kemungkinan gejala-gejala autisme tidak tercetus. Konsep baru mengatakan, gejala autisme timbul akibat racun-racun dari lingkungan yang tidak bisa dibersihkan lantaran anak memiliki kelemahan genetik.

”Faktor pemicu autisme itu banyak, tidak mungkin satu pemicu saja. Selain keracunan logam berat, anak-anak penyandang autisme biasanya juga mengalami alergi, kondisi pencernaannya juga jelek,” kata Melly. Ada kecurigaan, salah satu faktor pencetus autisme adalah logam berat merkuri.

Di Palangkaraya, misalnya, ada pusat terapi autisme yang muridnya berjumlah hampir 200 anak. Padahal, jumlah penduduknya hanya sekitar 250.000 jiwa. Jadi, prevalensi autisme di daerah itu satu per 250 penduduk. Setelah ditelusuri, warga setempat sehari-hari mengonsumsi ikan dari Sungai Kahayan, padahal sungai itu jadi lokasi pertambangan liar emas sekaligus pembuangan merkurinya.

Repotnya, menurut Melly, banyak vaksin yang beredar di pasaran mengandung merkuri. Satu suntikan vaksin dari luar negeri biasanya merkuri yang dikandung 25 mikrogram. Bahkan, ada vaksin yang kandungan merkurinya lebih dari itu. ”Keterkaitan vaksin sebagai pencetus autisme masih jadi perdebatan di dunia internasional. Ini tentunya perlu penelitian lebih lanjut,” ujarnya.

Saat ini seorang anak hanya boleh menerima merkuri 0,1 mikrogram per kilogram berat badan. Jadi, anak Indonesia yang rata-rata memiliki bobot lahir 2,5-3 kilogram hanya boleh menerima 0,3 mikrogram. Akan tetapi, kenyataannya, sebagian bayi diimunisasi dengan vaksin yang mengandung merkuri sebanyak 25 mikrogram. ”Sekarang ada vaksin yang bebas merkuri, tapi harganya mahal,” kata Melly.

Terkait dengan isu bahwa vaksin MMR merupakan salah satu faktor pencetus terjadinya autisme pada anak, Menteri Kesehatan Siti Fadilah tidak bersedia berkomentar mengenai masalah itu. ”Ini masih perlu pengkajian lebih mendalam lagi. Kami perlu mengecek apakah memang benar vaksin itu terkait dengan autis,” katanya menambahkan.

Dukungan pemerintah

Sejauh ini, pemerintah dinilai kurang memberi perhatian terhadap masalah autisme yang kian merebak di sejumlah daerah. Pelayanan terapi bagi penyandang autisme masih sangat terbatas dan biayanya relatif mahal sehingga sulit dijangkau para orangtua dari anak penyandang autisme.

Banyak orangtua yang kesulitan membesarkan dan memberikan terapi terbaik bagi anak mereka yang menyandang autisme. Jika tidak dideteksi dan diterapi dengan tepat sejak dini, gangguan perkembangan itu akan membuat anak-anak penyandang autisme itu tidak bisa mandiri, sulit berkomunikasi dan berkarya di lingkungan masyarakat.

Pada kesempatan terpisah, Siti Fadilah menegaskan, pemerintah mendukung layanan kesehatan bagi anak-anak yang menyandang autisme. Salah satunya dengan memberi penyuluhan dan menyediakan pelayanan kesehatan dasar di puskesmas-puskesmas. Selain itu, pemerintah akan mengalokasikan dana untuk penanganan anak-anak berkebutuhan khusus termasuk autisme.

Namun diakui, penanganan kesehatan bagi para penyandang autisma masih belum jadi prioritas pembangunan bidang kesehatan. ”Indonesia masih disibukkan dengan pengendalian penyakit menular. Penanganan autisma masih belum jadi prioritas utama,” kata Kepala Pusat Komunikasi Publik Depkes Lily S Sulistyowati.

Sejauh ini, pemerintah belum mampu menyediakan pusat-pusat terapi bagi penyandang autisma. Tempat-tempat pelayanan terapi masih dikelola pihak swasta dengan biaya cukup mahal. Padahal, sebagian besar penyandang autisma butuh sejumlah terapi untuk mengatasi gangguan perkembangan, terutama kemampuan komunikasi.

Mengingat meningkatnya angka kasus autisma di Indonesia dalam beberapa tahun terakhir ini, Sekretaris Jenderal Depkes Sjafii Ahmad menyatakan, Depkes berencana mendirikan Pusat Inteligensia yang menangani masalah terkait gangguan inteligensia dan perkembangan termasuk autisma. ”Nantinya, pusat inteligensia juga akan didirikan di tiap provinsi,” ujarnya.

Tentunya, janji pemerintah untuk lebih serius menangani masalah autisme ditunggu realisasinya. Bagaimanapun, para penyandang autisme merupakan anak-anak bangsa yang ikut menentukan masa depan Indonesia. Jangan sampai mereka kelak jadi generasi yang hilang.

Menkes Jamin Vaksin Indonesia Halal Digunakan

http://www.eramuslim.com/berita/nas/8504125543-menkes-jamin-vaksi-indonesia-halal-digunakan.htm
Menkes Jamin Vaksin Indonesia Halal Digunakan

Minggu, 4 Mei 08 14:19 WIB

Menteri Kesehatan (Menkes) Siti Fadilah Supari menjamin kehalalan vaksin yang beredar di Indonesia. Menurutnya ada dugaan asing melakukan upaya pelemahan industri farmasi dalam negeri dengan menghembuskan isu vaksin haram digunakan.

“Masyarakat tidak perlu khawatir, saya jamin kehalalan vaksin yang beredar di Indonesia karena dibuat oleh Pabrik Farmasi dalam negeri Bio Farma, ” ujar Menteri Kesehatan dalam acara bedah buku karyanya: Tangan Tuhan di Balik Virus Flu Burung di Serang Banten.

Indonesia sendiri, lanjut Menkes, merupakan pasar yang menggiurkan. Namun, di sisi lain Indonesia, sebagian besar juga sudah bisa menyediakan dan memproduksi vaksin sendiri dan tidak tergantung pada negara barat yang maju.

“Hanya tiga negara berpenduduk Islam di dunia ini yang bisa memproduksi vaksin sendiri, yaitu Iran, Malaysia dan Indonesia, ” katanya.

Karena itu, menurut Siti Fadilah, ada negara atau perseorangan yang tidak suka Indonesia mampu memproduksi vaksin sendiri. Selain karena latar belakang motif ekonomi juga dikarenakan motif ideologis. “Salah satunya isu kehalalan vaksin, karena ada dugaan negara lain tidak ingin melihat kita maju, ” kata Menkes.

Yang menjadi keprihatinan Menkes, ada salah satu negara di Timur Tengah yang kurang mendukung program vaksin halal hasil riset dan produksi buatan pabrik dari negara-negara Islam.

“Kami kecewa, negara Islam paling kaya sendiri yang malah membeli vaksin dari Amerika Serikat, dan kurang mendukung upaya memajukan vaksin halal, ” kata Menkes RI yang masuk dalam anggota Menkes negara-negara OKI itu.

Sentimen persaingan bisnis dan motif ideologis dalam hal ini WHO juga disampaikan Ketua Medical Emergency for Rescue Committe (Mer-C) Joserizal Jurnalis. “Biofarma pernah didiskreditkan oleh WHO hanya karena BUMN ini menguasai pasar yang sangat besar, ” kata Jose.

Lebih jauh ia menilai Arab Saudi kurang peka terhadap isu kebersamaan dan ideologis di balik bisnis vaksin ini. Hal itu terbukti dari kewajiban masyarakat seluruh dunia menyuntikkan vaksin meningitis sebelum menunaikan ibadah haji.

“Dan anehnya Arab Saudi membeli vaksin meningitis tersebut dari Amerika Serikat, ” ujarnya. (novel)

Ramai-Ramai Gugat Vaksinasi

http://hidayatullah.com/index.php?option=com_content&task=view&id=6830&Itemid=1

Ramai-Ramai Gugat Vaksinasi
Selasa, 13 Mei 2008
Ibu-Ibu Amerika Gugat Vaksinasi karena dianggap Berbahan Pengawet Thimerosal, Dituding Sebabkan Autisme

Hidayatullah.com–Pemberian vaksin kepada anak-anak yang bertujuan meningkatkan kekebalan tubuh malah dirasa bermasalah. Itulah yang kini terjadi pada ibu-ibu di Amerika Serikat (AS). Mereka merasa bahwa vaksin dengan bahan pengawet thimerosal yang diberikan kepada anak-anak mereka telah memicu sindrom autisme.

Thimerosal adalah senyawa organomerkuri. Di AS, thimerosal biasa digunakan untuk antiseptik dan antifugal. Kandungan merkuri thimerosal bisa mencapai 49 persen.

Ibu-ibu yang merasa dirugikan kemarin mengajukan gugatan ke pengadilan. Pengacara mereka berusaha menunjukkan bahwa bahan pengawet yang menggunakan merkuri dapat memicu gejala autisme.

Sebagai bukti nyata, seorang anak laki-laki dari Portland, Oregon, akan menjalani serangkaian tes untuk membuktikan hal itu. Pengacaranya menyatakan bahwa bocah tersebut sebelum divaksinasi dalam kondisi sehat, bahagia, dan normal.

Tapi setelah divaksinasi dengan thimerosal, kondisinya mengalami kemunduran. Jika hal itu terbukti benar, ratusan keluarga tersebut akan mendapatkan uang kompensasi.

Secara keseluruhan, hampir 4.900 keluarga telah mengajukan klaim ke Pengadilan Federal AS (pengadilan yang menangani klaim melawan pemerintah AS, Red). Mereka menyatakan bahwa vaksin tersebut menyebabkan autisme dan masalah-masalah saraf pada anak-anak mereka.

Pengacara dari keluarga yang mengajukan gugatan menyatakan bahwa mereka akan menunjukkan bukti bahwa suntikan vaksin yang mengandung thimerosal menyebabkan endapan merkuri di otak. Zat merkuri tersebut telah membangkitkan sel otak tertentu yang memicu autisme sehingga anak cenderung acuh.

“Di beberapa anak, ada cukup merkuri untuk membuat pola neuroinflammatory kronis yang dapat memicu penyakit autisme regresif,” ujar Mike Williams, salah seorang pengacara para ibu tersebut.

Badan ahli khusus dari pengadilan telah menginstruksi penggugat untuk melakukan tes untuk membuktikan teori penyebab autisme tersebut. Mereka juga menunjuk tiga ahli untuk menangani kasus itu.

Tiga kasus di kategori pertama pernah didengar dan diajukan tahun lalu, namun sampai saat ini belum ada keputusannya. Kasus yang disidangkan kemarin difokuskan pada teori kedua tentang penyebab autisme.

Teori tersebut menyatakan bahwa thimerosal yang terdapat dalam vaksin menyebabkan autisme. Para pengacara keluarga itu berharap bisa meyakinkan para ahli bahwa thimerosal menyebabkan peradangan yang memicu autisme regresif.

Namun, banyak di antara anggota komunitas medis merasa skeptis terhadap klaim tersebut. Mereka takut klaim itu akan mengakibatkan beberapa orang tidak melakukan vaksinasi atas anak-anaknya.

“Yang saya sayangkan adalah orang-orang yang antivaksin akan beralih dari satu hipotesis ke hipotesis berikutnya tanpa menengok kasus di belakangnya,” ujar Dr Paul Offit, direktur pusat pendidikan vaksinasi di rumah sakit anak Philadelphia.

Sebenarnya, beberapa tahun belakangan thimerosal telah dihilangkan dari standar vaksinasi anak-anak, kecuali dalam vaksin flu yang tidak dikemas dalam satu dosis. Pusat pengendalian penyakit AS (Centers for Disease Control/CDC) menyatakan bahwa vaksin flu yang mengandung thimerosal hanya tersedia dalam jumlah yang terbatas.

Pada 2004, institut obat-obatan di AS telah mengadakan penelitian tentang penggunaan thimerosal dalam vaksin. Berdasar penelitian tersebut, tidak ada bukti-bukti nyata yang menunjukkan bahwa penggunaan thimerosal dapat memicu autisme pada anak-anak.

Meski demikian, ratusan keluarga yang menuntut mempunyai pendapat berbeda. Berdasar pengalaman, anak-anak mereka menderita gejala autisme setelah pemberian vaksin dengan thimerosal tersebut.
Website yang dirilis pengadilan menunjukkan bahwa lebih dari 12.500 klaim telah diajukan sejak program vaksinasi dengan thimerosal pada 1987. Dari keseluruhan klaim tersebut, 5.300 klaim adalah kasus autisme dan lebih dari USD 1,7 miliar (Rp 15,7 triliun) telah dibayarkan. Website itu juga menyatakan bahwa saat ini lebih dari USD 2,7 miliar (Rp 24,94 triliun) dana yang berasal dari pajak pertambahan nilai telah disediakan untuk meng-cover jika terjadi masalah dalam program vaksinasi. [ap/cha/berbagai sumber/www.hidayatullah.com

Karima Burns: Cintaku kepada Islam tertambat di Istana Al-Hambra

http://hidayatullah.com/index.php?option=com_content&task=view&id=6819&Itemid=1

Karima Burns: Cintaku kepada Islam tertambat di Istana Al-Hambra

Sabtu, 10 Mei 2008

Ketika membuka Al-Quran perasaan yang hadir persis seperti orang yang baru saja menemukan kembali anggota keluarganya yang telah lama hilang

Hidayatullah.com–Karima Kristie Burns, MH, ND nama lengkapnya. Karima (39) dikenal sebagai perempuan dengan banyak bakat. Ya sebagai editor, penulis, guru, dan juga pakar herbalis. Di dunia herbalis dia sangat dikenal lewat konsultasi online di website Herb’n Muslim yang dikelolanya sejak 1994. Sejak masuk Islam, dia membuka usaha Herb’n Muslim yang dikenal dengan teknik penyembuhan alami dan islami. Dia juga telah menulis lebih dari 120 artikel kesehatan yang bisa didownload via websitenya itu. Karima menghabiskan separuh hidupnya di Midwest, Iowa (AS), tempat dia dibesarkan. Dan separuhnya lagi di kawasan Timur Tengah (Mesir dan Arab Saudi).

Karima mulai tertarik dengan metode penyembuhan alami justru ketika berupaya menyembuhkan dirinya sendiri yang mengidap penyakit asma, alergi, mudah panik, depresi, dan beberapa penyakit bagian dalam lainnya. Kala itu dia mencoba dengan terapi alami dan bantuan tumbuh-tumbuhan. Dia berkeliling hingga ke Mesir guna mencari berbagai informasi berkenaan penyembuhan tradisional. Dari kegigihannya itu, dia bahkan berhasil memperoleh gelar formal master of herbalist dan doktor bidang naturopathic tahun 1996 dari Trinity College di Dublin, Irlandia. Naturopathic adalah teknik pengobatan alamiah yang meresepkan herbal untuk para pasiennya. Namun tak banyak yang tahu, ketertarikan Karima kepada Islam justru ketika berkunjung ke Spanyol. Dia mengaku terkagum-kagum dengan tulisan Arab di Istana Al-Hambra di kota Granada. Istana itu sendiri dulunya bekas mesjid hingga bekas kaligrafinya masih ada. Berikut penuturan Karima yang disadur dari beberapa sumber.

***

Kenal Islam di Spanyol

Karima Burns awalnya adalah seorang mahasiswi program sarjana studi kawasan Arab di Universitas Iowa, AS. Karima mengaku Islam hadir di hatinya berawal dari membaca rangkaian tulisan ayat suci Al-Quran dalam rangka penyelesaian tugas kuliahnya. Dan dia tak kuasa menghindar dari bisikan hati itu.

Ceritanya, satu ketika dia dan teman-temannya mengadakan studi tur ke Granada, Spanyol. Granada merupakan salah satu bekas kawasan yang pernah dikuasai Islam selama hampir tujuh abad. Kala itu dia sedang duduk-duduk di Istana Al-Hambra. Istana itu dulunya adalah mesjid. Karima takjub melihat jejeran tulisan di dinding gedung tua itu. Baginya itulah tulisan terindah yang pernah dia lihat.

“Bahasa apa itu?” tanyanya pada salah seorang turis Spanyol. ”Bahasa Arab,” sahut turis lokal itu. Hari berikutnya, tatkala pemandu wisata menanyakan buku panduan dalam bahasa apa yang dia inginkan, Karima menjawab spontan bahasa Arab.

“Apa, bahasa Arab? Anda bisa bahasa Arab?” tanya si pemandu terkejut.

“Tidak, tapi tolong berikan juga yang dalam bahasa Inggris,” sahut Karima.

Di akhir tour tas Karima penuh dengan buku-buku petunjuk wisata dari tiap-tiap kota yang dia singgahi di seluruh Spanyol. Dan semuanya dalam bahasa Arab!

“Tas travel saya sudah terlalu penuh hingga saya bermaksud membuang beberapa potong pakaian dan beberapa barang lainnya agar tasnya bisa muat. Namun, untuk buku-buku bahasa Arab rasanya berat untuk ditinggalkan. Buku-buku itu ibarat emas bagi saya. Saya sering membolak-balik halamannya tiap malam. Kata per kata-nya saya amati dengan seksama. Huruf-hurufnya juga unik, beda dengan huruf latin biasa. Saya membayangkan andainya saja bisa menulis dengan huruf yang demikian indah itu. Waktu itu saya punya pikiran pasti akan sangat berharga jika bisa mengetahui bahasa Arab ini. Saya pun berniat dalam hati untuk belajar bahasa ini. Ya satu saat nanti kala kembali ke kampus di musim gugur,” tukas Karima.

Mencari jawaban

“Ketika itu ada sekitar dua bulan saya meninggalkan keluarga di Iowa untuk mengikuti tour sepanjang kawasan Eropa ini. Sendirian pula. Kala itu usia saya baru 16. Makanya saya kepingin jalan-jalan dulu sembari “melihat dunia”. Itu alasan yang saya katakan pada keluarga dan kawan-kawan. Tapi sebenarnya saya sedang mencari jawaban atas konsep Kristen yang sudah lama saya pendam. Saya meninggalkan gereja (baca: Kristen -red) persis beberapa bulan sebelum berangkat ke Eropa dan belum bisa menentukan pilihan (agama) lain. Saya merasa belum mendapatkan apapun dengan apa yang telah saya pelajari selama ini. Sampai kini pun belum mendapatkan alternatif-alternatif lain,” ungkapnya.

“Tempat dimana saya dibesarkan, yakni Midwest, sebenarnya sangat cocok buat saya. Misalnya hal keyakian, tidak ada yang perlu dipusingkan disana. Mau jadi bagian dari gereja silahkan. Tidak, ya juga ndak masalah. Tapi karena itu pula saya tidak punya gambaran agama lain yang bisa dijadikan alternatif. Makanya ketika ada waktu keliling Eropa saya berharap bisa berjumpa dengan “sesuatu” yang lain itu,” imbuhnya.

“Di gereja tempat kami tinggal, kami hanya boleh melakukan ibadah untuk Yesus dan menyandarkan segala sesuatu padanya agar bisa menyampaikan pesan kepada Tuhan. Secara intuitif saya merasakan bahwa ada sesuatu yang salah dengan dogma itu,” kata dia.

“Saya kala itu dengan patuh pergi ke gereja tiap hari minggu dan sangat serius dengan apa yang saya pelajari tentang kejujuran, murah hati dan saling berkasih sayang. Tapi ada yang bikin saya bingung tatkala melihat jamaag gereja. Sikap mereka tampak begitu beda selama satu hari itu. Apakah Cuma sehari dalam sepekan bersikap jujur, murah hati dan kasih sayang? Apakah mereka cuma bahagia di hari minggu saja? Aku mencari-cari di beberapa buku panduan, namun tak menemukan apa-apa. Ada hal tentang 10 perintah Tuhan yang meliputi hal-hal yang sudah nyata sekali seperti larangan membunuh, mencuri dan berbohong. Uniknya, orang-orang ke gereja seperti tak ada etiket. Misalnya, sejauh yang saya tahu, banyak yang pakai rok mini ke gereja. Ironisnya lagi, ada juga dari mereka pergi ke sekolah minggu hanya karena ada cowok ganteng disana,” tukas Karima.

Kitab Bibel aneka versi

Satu hari Karima berkunjung ke rumah salah seorang dosennya. Disana dia melihat beberapa kitab Bibel tersusun rapi di rak lemari si dosen. “Saya tanya apa itu. Dosennya menjawab bahwa itu kitab Bibel dalam berbagai versi. Saya sebenarnya tak mau mengganggunya dengan pertanyaan seputar Bibel dalam aneka versi itu. Tapi makin dipendam makin sangat mengganggu pikiran. Saya beranikan diri mengamati beberapa dari Bibel itu. Saya terkejut. Memang ada yang benar-benar beda satu versi dengan versi lainnya. Bahkan ada beberapa bab yang tidak sama dengan Bibel kepunyaan saya. Kala itu saya benar-benar bingung. Bahkan mulai timbul perasaan bimbang,” katanya-

Ikut kelas bahasa Arab

Selepas tur Eropa Karima kembali ke kampus dengan perasaan kecewa sebab tak menemukan jawaban yang diharapkannya. Akan tetapi dengan keinginan yang begitu besar akan sebuah bahasa, Karima mengaku tertarik untuk mempelajari bahasa Arab. “Ironis ya, mendapat secercah jawaban yang saya cari-cari justru di dinding istana Al Hambra. Setelah pulang dari Spanyol, butuh dua tahun bagi saya untuk merealisasikan semua itu (masuk Islam-red),” ujarnya.

“Hal pertama sekali yang saya lakukan kala aktif kembali di kampus adalah mendaftar kelas bahasa Arab. Saya amati tampaknya kelas itu tidak begitu diminati. Entah kenapa. Buktinya peserta yang mendaftar cuma tiga. Saya dan dua mahasiswa lainnya. Tapi saya tak ambil pusing,” kata dia. Karima pun langsung tenggelam dengan pelajaran bahasa Arab. Rasa ingin tahunya sangat tinggi, hingga sang dosen takjub melihatnya.

“Saya kerjakan tugas-tugas yang diberikan dengan pulpen khusus untuk menulis huruf kaligrafi. Bahkan seringkali saya pinjam buku-buku dalam bahasa Arab dari dosen hanya untuk melihat huruf-huruf Arab yang ada dalam buku itu. Memasuki tahun kedua di universitas, saya putuskan untuk memilih bidang Studi Timur Tengah. Jadi dengan begitu bisa fokus pada satu kawasan saja. Nah di salah satu mata kuliahnya adalah belajar Al-Quran. Saya gembira bukan main,” aku Karima mengenang.

Kagum dengan Al-Quran

“Satu malam saya buka Al-Quran untuk mengerjakan PR. Heran campur takjub. Makin saya baca makin terasa nikmat. Sulit untuk berhenti membacanya. Persis seperti seseorang baru mendapatkan sebuah novel baru. Ketika itu saya bergumam dalam hati; wow menarik sekali. Inilah yang selama ini saya cari-cari. Semuanya ada dalam Al-Quran. Semua penjelasan betul-betul menarik. Saya sungguh kagum, kitab suci ini menguraikan semua yang juga saya percayai dan saya cari-cari jawabannya selama bertahun-tahun. Sangat jelas disebutkan bahwa hanya ada satu Tuhan yang patut disembah, yakni Allah. Tidak seperti di Kristen, satu dalam tiga,” imbuhnya.

Hari berikutnya Karima kembali ke ruang kelas untuk menanyakan siapa gerangan pengarang kitab itu. Karima melihat ada sebuah nama tertulis di halaman depan Al-Quran itu. “Awalnya saya menyangka itu nama pengarangnya. Misalnya seperti kitab Gospel yang dikarang oleh St. Luke atau kitab-kitab dalam agama lain yang pernah saya pelajari sebelumnya,” kata dia.

Salah seorang dosen Karima yang beragama Kristen memberitahu bahwa itu bukan nama pengarangnya. “Ternyata itu adalah nama penerjemahnya. Masih menurut dosen itu, dia mengutip pernyataan penganut Islam, bahwa tak ada seorang pun yang mampu menulis kitab suci itu. Quran, kata orang Islam, merupakan perkataan Allah dan tidak berubah dari pertama diturunkan hingga saat ini. Al-Quran dibaca dan dihafal banyak orang. Wow…tak perlu saya katakana bagaimana gembiranya hati saya. Makin terpesona dan takjub. Setelah penjelasan itu saya tambah tertarik, bukan hanya mempelajari bahasa Arab, tapi juga mempelajari Islam. Hingga timbul keinginan pergi ke Timur Tengah,” katanya sumringah.

Masuk Islam

Di tahun terakhir kuliah akhirnya Karima mendapat kesempatan mengunjungi Mesir. Salah satu tempat favorit yang ingin dia lihat di sana adalah mesjid. “Saya merasakan seolah-olah sudah jadi bagian dari mereka. Berada di dalam mesjid, keagungan Allah semakin nyata. Dan, seperti biasanya, saya sangat menikmati rangkaian tulisan kaligrafi yang ada di dinding mesjid itu,” kata dia.

Satu hari seorang teman menanyakan kenapa tidak masuk Islam saja kalau memang sudah sangat tertarik. “Tapi saya sudah jadi seorang muslim,” kata Karima. Si teman terkejut mendengar jawaban itu. Tak cuma dia, bahkan Karima sendiri terkejut dengan jawaban spontan yang keluar dari bibirnya. “Tapi kemudian saya sadari hal itu logis dan normal. Islam telah merasuk dalam jiwa saya dan selalu memberikan perasaan lain. Begtupun pernyataan teman saya itu ada benarnya. Kenapa saya tidak masuk Islam saja?” tanya Karima pada dirinya sendiri. Temannya menyarankan agar lebih resmi (masuk Islam) sebaiknya pergi ke mesjid saja dan menyatakan keislaman di hadapan jamaah di sana sebagai saksinya.

“Tanpa menunggu lama saya ikuti sarannya. Ringkas saja, Alhamdulillah, akhirnya saya pun bersyahadat. Pihak mesjid lalu memberikan selembar sertifikat resmi selepas bersyahadat. Tapi sertifikat itu tak penting dan hanya saya simpan dilemari. Sama seperti dokumen-dokumen lain seperti asuransi, ijazah dan lainnya. Tak ada niat menggantung kertas itu di dinding rumah sebagai bukti telah ber-Islam. Bagi saya yang penting sudah jadi seorang muslim,” akunya.

“Kini saya habiskan waktu hanya untuk mempelajari Al-Quran. Ketika membuka Al-Quran perasaan yang hadir persis seperti orang yang baru saja menemukan kembali anggota keluarganya yang telah lama hilang,” ungkap Karima. Di rumahnya Karima tak lupa menggantung foto Istana Al Hambra, tempat dimana dia pertama kali melihat tulisan Arab yang membuat dirinya takjub dan jatuh cinta dengan Al-Quran. Kini, disamping mengelola praktek penyembuhan alaminya dia juga aktif menulis. Ada lebih dari 120 artikel yang telah dia tulis. Umumnya bertema kesehatan. Tulisannya yang terkenal antara lain The “Yoga” of Islamic Prayer, Vetegarian Muslim, dan banyak lainnya lagi. Begitulah. [Zulkarnain Jalil/dari berbagai sumber/www.hidayatullah.com]

Kutipan terjemahan tulisan dr Tom Heller, mewakili para orang tua dan dokter atau praktisi autisme:

http://puterakembara.org/rm/mmr.shtml

01/22/2002

Kutipan terjemahan tulisan dr Tom Heller, mewakili para orang tua dan dokter atau praktisi autisme:

Salah satu tugas saya sehari hari sebagai seorang praktisi atau dokter di Inggris adalah memberikan imunisasi pada bayi dan balita. Tapi belakangan ini saya semakin tidak yakin ketika memberikan vaksinasi kombinasi MMR dan berpikir apakah saya juga harus memberikan vaksinasi ini pada anak-anak saya jika mereka ada pada usia semuda itu.

Sulit bagi saya untuk merasa yakin bahwa vaksin itu aman seperti yang di-umumkan pemerintah. Semakin keras suara para ahli saya merasa semakin ragu akan kebenarannya. Situs Departemen Kesehatan memberikan banyak bukti dan links mengenai vaksin ini hanya menghasilkan satu isu baru yaitu vaksin MMR mempunyai efek samping yang buruk.

Penggunaan bukti klinis secara tidak lengkap juga dikumandangkan oleh para ahli lainnya. Seperti pada Elliman dan Bedford yang menyerang metode riset yang digunakan oleh orang orang yang prihatin terhadap efek samping vaksin MMR. Pada saat yang sama, mereka malah tidak memperhatikan akan bahaya yang terjadi dengan hasil riset yang menyimpulkan bahwa vaksin MMR aman dipakai.

Program NHS mengkhususkan diri dalam memberikan pelayanan dan pengobatan pada masyarakat luas. Tetapi dengan alasan tertentu, ketika mencoba untuk mendiskusikan mengenai masalah vaksinasi MMR, kelihatan sangat dibatasi. Para orang tua menjadi cemas. Dan mereka yang mempunyai anak penyandang autisme menjadi semakin kuatir karena merasa kemungkinan keadaan ini disebabkab oleh vaksinasi.

Sekelompok orang tua lain merasa yakin akan hubungan antara vaksin MMR dan anak mereka dan telah membentuk kelompok dan organisasi untuk meloby. Di Inggris, organisasi ini dikenal dengan nama JABS, Justice, Awareness and Basic support. Ketika beberapa hasil observasi yang dilakukan oleh keluarga yang terkena dampak buruk vaksinasi kemudian di-kategorikan sebagai insiden terisolir, mungkinkah hasil observasi seperti ini dapat dijadikan bukti?

Saya tidak sendirian dalam keprihatinan dan mungkin kebingungan mengenai pemberian vaksinasi MMR. Beberapa penelitian mengenai pemberian vaksinasi MMR dosis kedua telah dilakukan di daerah north Wales dengan hasil menunjukkan hanya 45% profesional yang terdiri dari 54% praktisi atau dokter umum setuju untuk memberikan dosis kedua MMR pada anak. Namun hal ini tidak berpengaruh banyak terhadap jumlah anak yang di-vaksinasi MMR yang secara nasional pada tahun 1994 dan 1995 hanya turun dari 91% ke 88%. Pada tahun 1998 – 1999 dibeberapa daerah terlihat hanya 75%
Saat ini, tidaklah mudah untuk mempertanyakan hal ini pada pemerintah. Contohnya, Andrew Wakefield, penanggung jawab dari beberapa riset yang mempertanyakan mengenai pengembangan vaksin MMR telah di-vonis melakukan penyalah gunaan etika profesional. Mungkin pilihan yang paling mudah adalah dengan menundukkan kepala anda dan tidak membicarakan isu ini.

Kutipan terjemahan tulisan dr Dick Heller, mewakili pemerintah:

Para orang tua sering tidak akurat dalam mengidentifikasikan penyebab dari penyakit mereka. Anekdot atau cerita mengada ada dari seseorang tidak akan dapat berbuat banyak selain hanya menghasilkan sebuah hipotesis yang memerlukan penyelidikan lebih lanjut secara klinis. Keprihatinan publik terjadi akibat ketidak mampuan untuk mengerti dan meng-ekspresikan bukti-bukti klinis. Yang kita dapati saat ini adalah hipotesis yang berdasarkan anekdot tanpa bukti klinis. Adapun bukti bukti lemah yang ada tidak dapat menunjang hipotesis.

Membandingkan resiko autisme dan resiko pemberian vaksinasi pada anak

Sangat sulit untuk mengerti, mengukur dan mengekspresikan resiko. Angka angka menunjukkan bahwa tiap 100 000 anak terdapat 91 penyandang gangguan spektrum autisme. Jika 15% dari anak-anak ini menjadi penyandang autisme sebagai akibat di-vaksinasi MMR maka sebanyak 7326 anak harus divaksinasi untuk dapat satu anak penyandang autisme. Berapa banyak kasus penyakit mumps , measles dan rubella akan timbul jika anak tidak di-vaksinasi MMR? Bagaimana rate komplikasi ? Sayang sekali, kami tidak mempunyai sistim intelejen yang canggih untuk menyelidiki efek dari perubahan pemberian imunisasi terhadap kesehatan masyarakat. Namun kami tahu bahwa untuk measles saja angka kematian 1 – 2 dari tiap 1000 orang yang terinfeksi di Amerika Serikat dan 1 dari 1000 akan terkena encephalitis beberapa diantaranya akan terkena kerusakan otak permanen. Jika semua anak yang tidak divaksinasi terjangkit measles maka rate komplikasi menyebutkan bahwa penyetopan vaksinasi akan sangat berbahaya – jauh lebih berbahaya dari pada usaha pencegahan insiden timbulnya gangguan autisme.

Dalam memerangi penyakit menular umum seperti yang disarankan oleh pemerintah untuk mendapatkan vaksinasi akan sulit untuk dapat diatasi jika tingkat pemberian imunisasi di suatu komunitas turun dibawah level kritis. Mereka yang bertanggung jawab terhadap kesehatan publik akan mempunyai kepentingan yang sah untuk meningkatkan pemberian vaksinasi.

Secara umum dapat saya katakan tidak terdapat bukti bahwa vaksin MMR dapat menyebabkan autisme dan tidak terdapat cukup bukti pula untuk mengatakan bahwa vaksin MMR tidak menyebabkan autisme. Saya percaya bahwa dengan menyetop vaksinasi pada anak atas dasar hipotesa yang tidak lengkap akan sangat berbahaya

Kutipan tulisan Stephen Pattison menanggapi tulisan dr Tom Heller dan dr Dick Heller:

Beberapa kaum moralis akan berkata bahwa Tom Heller sedang dalam keadaan emosional tapi menurut saya keadaan gundah ini adalah bagian dari tanggung jawab moral. Tom Heller mengaplikasikan apa yang disebut the golden rule untuk menentukan apa yang benar dan apa yang salah ketika ia mengatakan “apakah saya juga harus memberikan vaksinasi ini pada anak-anak saya pada usia semuda itu”. Ia juga menyuarakan pendapat pemerintah dengan mengatakan bahwa pemberian vaksinasi MMR itu aman. Dan juga bagaimana keraguannya semakin tinggi yang mana bertolak belakang dengan kebanyakan ahli.

Pertanyaannya adalah bagaimana rekan kerja Tom Heller, para dokter umum dan masyarakat awam, dengan segala keterbatasan pengetahuan-nya dapat mengambil manfaat dan dapat hidup dengan kenyataan yang ada tanpa harus mengabaikan pentingnya kesehatan masyarakat?

Walaupun ilmuwan dan peneliti hidup dalam paradigma rasional dan serba korelatif sedangkan masyarakat awam termasuk dokter mempunyai pandangan yang lebih kompleks sehingga dilihat dari kaca mata kaum rasional, pengetahuan komposit masyarakat awam sering terlihat sebagai suatu yang tidak rasional dan suatu yang gaib sehingga harus di-buang dan dihilangkan.

Anda tidak dapat membatasi pengetahuan orang lain bahkan ketika anda sendiri ragu akan kemampuan ilmu pengetahuannya. Membuat keputusan untuk tidak memberikan vaksinasi adalah suatu dilema moral bagi orang tua dan ini haruslah dihormati. Melecehkan dilema moral orang lain tidak akan dapat menyelesaikan masalah. Kini telah terjadi krisis kepercayaan terhadap penilaian teknis vaksinasi MMR dan juga krisis untuk dapat saling menghargai. Perlu dibuat suatu keputusan untuk mendapatkan bukti-bukti yang dapat dipertanggung jawabkan demi untuk menegakkan kenyataan yang sebenarnya. Untuk melaksanakan ini pihak ilmuwan agar tidak menanggapi ketakutan dan kekuatiran sebagai bentuk ketidak pedulian dan kemudian berusaha menghancurkannya dengan menggunakan instrumen rasional mereka.

Dalam hal ini telah terjadi ketidak seimbangan antara resiko dan kekuasaan. Pihak pemerintah menentukan strategi risk management untuk menghadapi penyakit mumps, measles dan rubella. Sedangkan para dokter dan orang tua sebagai pelaksana strategi ini harus menghadapi segala konsekuensinya. Isu vaksinasi MMR ini sempat membuat kami prihatin akan etika klinis dan pelayanan publik yang responsif dan berguna. Kami akan mencoba untuk mencari bentuk ideal dari bukti-bukti klinis yang dapat diterima baik oleh masyarakat maupun oleh individu yang menggangap hal tersebut sensitif.

Kutipan tanggapan dr Tom Heller mengenai tulisan Stephen Pattison:

Saya merasa telah menjalani suatu proses yang mirip dengan apa yang dialami para orang tua pada saat mereka memutuskan untuk memberikan vaksinasi pada anak mereka. Saya akan terus mencari untuk dapat mengerti mengenai hal ini. Tentunya, saya sangat menghargai pendapat pihak penguasa yang menyimpulkan bahwa MMR adalah aman untuk diberikan pada anak, akan tetapi keragu raguan tetap melekat pada saya seperti juga ada pada banyak orang lain.

Kesimpulan akhir saya adalah : ” Penolakan haruslah tetap menjadi pilihan yang dapat diterima di alam demokrasi yang bebas. Budaya berpendapat terkecuali yang berhubungan dengan agama dan filsafat haruslah tetap dilestarikan. Hal yang paling sulit adalah menciptakan keseimbangan antara hak suatu negara untuk mengontrol penyakit menular dan hak individual serta masyarakat awam untuk memilih.

Referensi:
FEAT Daily Newsletter dan British Medical Journal online
How Safe is MMR Vaccine – Tom Heller, general practioner, School of Health and Social Welfare at the Open University, Milton Keynes UK
Validity of Evidence – Professor of Public Health. Evidence for Population Health Unit, School of Epidemiology and Health Sciences, Medical School, University of Manchester, UK
Dealing with Uncertainty – Stephen Pattison, Head Department of Religious and Theological Studies, Cardiff University.

——————————————————————————
Puterakembara menyajikan terjemahan tulisan ini adalah sehubungan dengan pertanyaan dari salah satu orang tua mengenai vaksinasi MMR. Kami berusaha untuk memberikan informasi secara netral dan se-akurat mungkin. Puterakembara tidak bertanggung jawab atas isi artikel maupun kesalahan dalam menterjemahkan artikel tersebut kedalam bahasa Indonesia.

Artikel diatas hanya dapat digunakan sebagai informasi atau sekedar untuk menambah pengetahuan. Informasi yang ada dalam artikel ini tidak dapat digunakan untuk menggantikan advis dokter atau pengobatan dan terapi yang hanya dapat dilakukan oleh dokter ahli / praktisi profesional di-bidang imunisasi ataupun kelainan spektrum autisme.

Review Buku: Yang Orangtua Harus Tahu tentang Vaksinasi pada Anak

http://www.setiabudi.name/archives/359

Review Buku: Yang Orangtua Harus Tahu tentang Vaksinasi pada Anak
December 18th 2007, on Kesehatan, Ulasan Buku

Buku berjudul Yang Orangtua Harus Tahu tentang Vaksinasi pada Anak ini adalah saduran dari buku berjudul What Your Doctor May Not Tell You About Children’s Vaccinations karangan Stephanie Cave, M.D., F.A.A.F.P bersama Deborah Mitchell.

Diterbitkan dengan ISBN 979-22-349-4 yang diterbitkan pertama kali oleh PT. Gramedia Pustaka Utama cetakan pertamanya pada tahun 2003.

Buku yang sangat memukau saya karena menyajikan banyak informasi mengejutkan tentang vaksinasi yang tidak pernah ditemukan di media informasi apapun.

Selama ini setiap informasi yang kita terima mengenai vaksinasi adalah suatu hal yang harus dilakukan dan memiliki dampak nol persen terhadap kesehatan manusia.

Padahal sebagaimana tertulis dalam lembaran pertama buku ini disebutkan sebagai berikut, “Dalam hal vaksinasi anak, mencegah mungkin tidak lebih baik daripada menyembuhkan”.

Ditutup dengan kalimat berikutnya, “Jangan ambil resiko untuk kesehatan anak Anda! Pelajari lebih lanjut tentang vaksinasi yang ada pada masa kini dengan… ORANG TUA HARUS TENTANG VAKSINASI ANAK”.

Mengapa hal tersebut menjadi penting?

Karena sebagai orang tua, tentunya kita mengharapkan hal terbaik yang dapat kita berikan kepada seluruh anak kita. Hal tersebut hanya dapat diwujudkan jika dan hanya jika kita memiliki informasi yang memadai mengenai apapun yang ingin kita persembahkan kepada mereka.

Fakta-fakta mengejutkan tentang kandungan merkuri yang digunakan dalam sebagian besar vaksin anak saat ini baru salah satu contoh mengerikan tentang vaksin yang harus Anda ketahui.

Berikut ini adalah beberapa hal yang mungkin tidak Anda ketahui tentang vaksin:

1. Beberapa vaksin mengandung racun seperti air raksa (merkuri), almunium dan formalin
2. Di tahun 1998, Pemerintah Perancis menghentikan program vaksinasi berbasis sekolah yang memberikan vaksin Hepatitis B kepada anak-anak usia sekolah karena kasus multiple-sklerosis telah dikaitkan dengan vaksin tersebut dan lebih dari 600 kasus imunitas dan persyarafan telah dilaporkan.
3. Beberapa vaksin dibuat menggunakan bahan yang berasal dari jaringan manusia dari janin yang digugurkan.
4. Kebanyakan negara mewajibkan bahwa saat anak berusia 5 tahun, ia sudah harus menerima 33 dosis dari 10 vaksin.
5. Para dokter hanya melaporkan kurang dari 10 persen kejadian buruk yang berkaitan dengan vaksinasi dan/atau sesudah vaksinasi.

Selain itu salah satu isu keamanan yang menurut buku ini sering diabaikan adalah bahan-bahan tambahan yang terdapat dalam vaksin sebagai berikut:

1. Alumunium

Logam ini ditambahkan ke dalam vaksin dalam bentuk gel atau garam sebagai pendorong terbentuknya antibodi. Alumunium telah dikenal sebagai penyebab kejang, penyakit alzheimer, kerusakan otak dan dimensia (pikun). Logam ini biasanya digunakan pada vaksin-vaksin DPT, DaPT dan Hepatitis B.
2. Benzetonium Khlorida

Benzetonium adalah bahan pengawet dan belum dievaluasi keamanannya untuk dikonsumsi oleh manusia. Biasa digunakan sebagai campuran vaksin anthrax terutama diberikan kepada para personil militer.
3. Etilen Glikol

Biasa digunakan sebagai bahan utama produk antibeku dan digunakan sebagai pengawet vaksin DaPT, polio, Hib dan Hepatitis B.
4. Formaldehid

Bahan kimia yang terkenal sebagai zat karsinogenik (penyebab kanker) yang biasanya digunakan dalam proses pengawetan mayat, fungisida/insektisida, bahan peledak dan pewarna kain.

Selain beracun, menurut Sir Graham S. Wilson pengarang buku The Hazards of Immunization formalin tidak mamadai sebagai pembunuh kuman sehingga maksud penggunaannya sebagai penonaktif kuman dalam vaksin menjadi tidak berfungsi dengan baik.

Akibatnya adalah kuman yang seharusnya dilemahkan dalam vaksin tersebut malah menguat dan menginfeksi penggunanya.
5. Gelatin

Bahan yang dikenal sebagai alergen (bahan pemicu alergi) ini banyak ditemukan dalam vaksin cacar air atau MMR. Bagi kaum Muslim, gelatin menimbulkan isu tambahan karena biasanya bahan dasarnya berasal dari babi.
6. Glutamat

Bahan yang digunakan dalam vaksin sebagai penstabil terhadap panas, cahaya dan kondisi lingkungan lainnya. Bahan ini banyak dikenal sebagai penyebab reaksi buruk kesehatan dan ditemukan pada vaksin varicella.
7. Neomisin

Antibiotik ini digunakan untuk mencegah pertumbuhan kuman di dalam biakan vaksin. Neomisin menyebabkan reaksi alergi pada beberapa orang dan sering ditemukan dalam vaksin MMR dan polio.
8. Fenol

Bahan yang berbahan dasar tar batu bara yang biasanya digunakan dalam produksi bahan pewarna non makanan, pembasmi kuman, plastik, bahan pengawet dan germisida.

Pada dosis tertentu, bahan ini sangat beracun dan lebih bersifat membahayakan daripada merangsang sistem kekebalan tubuh sehingga menjadi berlawanan dengan tujuan utama pembuatan vaksin.

Fenol digunakan untuk pembuatan beberapa vaksin termasuk vaksin tifoid.
9. Streptomisin

Antibiotik ini dikenal menyebabkan reaksi alergi pada beberapa orang dan biasa ditemukan dalam vaksin polio.
10. Timerosal/Merkuri

Bahan yang sangat beracun yang selama beberapa puluh tahun digunakan pada hampir seluruh vaksin yang ada di pasaran. Padahal timerosal/merkuri adalah salah satu bahan kimia yang bertanggung jawab atas tragedi Minamata di Jepang yang menyebabkan lahirnya bayi-bayi yang cacat fisik dan mentalnya.

Berikut ini adalah beberapa kerusakan yang disebabkan keracunan merkuri:

1. Otak bayi masih mengalami perkembangan yang cepat dan merkuri bisa merusak sel otak secara menetap.
2. Sistem kekebalan tubuh bayi masih belum berkembang secara penuh sehingga bayi tidak mempunyai kemampuan melawan serangan benda asing (bakteri, virus dan racun lingkungan) secara benar.
3. Kemampuan tubuh bayi untuk membuang racun dari tubuhnya melalui hati belum berkembang sepenuhnya sehingga zat-zat berbahaya cenderung menetap di dalam tubuhnya seperti merkuri, formalin dan alumunium.
4. Penghambat darah-otak (selaput yang berada di antara darah yang beredar di tubuh dengan otak yang berfungsi bahan-bahan berbahaya mencapai otak) belum mampu menghalangi racun yang bisa merusak otak.
5. Gejala keracunan merkuri yang paling umum antara lain adalah:
* Perubahan suasana hati dan kepribadian, termasuk mudah marah dan malu
* Hilangnya sensasi dan masalah penglihatan serius
* Ketulian dan kecenderungan kesulitan berkomunikasi karenanya
* Kelemahan otot dan tidak adanya koordinasi tubuh yang baik
* Hilangnya/lemahnya ingatan
* Tremor/gemetaran

Belum lagi fakta-fakta yang disajikan dalam buku ini yang mengkaitkan vaksinasi yang berbahaya dengan meningkatnya kasus-kasus autisme saat ini.

Dimana kasus autisme ini ternyata memiliki kemiripan dengan gejala-gejala keracunan merkuri yang banyak digunakan dalam vaksin.

Hal yang menarik lainnya untuk kita di Indonesia yang sedang gencar-gencarnya melakukan vaksinasi polio melalui mulut (oral/dimakan) adalah fakta bahwa sejak tahun 2000 Sentra Pengendalian Penyakit Amerika Serikat sudah menghentikan vaksin oral dan digantikan dengan suntikan.

Mengapa? Karena vaksinasi polio oral terbukti menimbulkan sampai 10 kasus polio per tahun dan dituding menyebabkan gangguan serius pada sistem pencernaan terutama penyumbatan usus!

Lantas mengapa informasi-informasi tersebut cenderung tidak pernah terpublikasikan secara luas?

Alasannya tentu saja sederhana sekali: UANG.

Bisnis produksi dan penjualan vaksin bernilai milyaran dollar Amerika Serikat per tahun! Selain itu banyak sekali bukti-bukti yang kemudian dibungkam menelusuri bahwa penyakit-penyakit saat ini seperti HIV/AIDS, DBD (demam berdarah), flu burung, dsb adalah senjata biologi yang sengaja dikembangkan yang kemudian dilepaskan ke komunitas sehingga mendorong kebutuhan akan obat dan vaksin penyakit-penyakit tersebut.

Saya dan isteri pun akhirnya sepakat untuk tidak memvaksinasi puteri kami. Hal ini kami lakukan setelah berkonsultasi dengan banyak ahli kesehatan (kedokteran, kimia klinis, teknologi kesehatan, dsb).

Apalagi ternyata teman-teman kami yang menjadi atau sedang kuliah menjadi dokter di Eropa secara terang-terangan menyatakan “vaksinasi adalah fiksi seperti cerita manusia mendarat di bulan..”

Muslims urged to refuse ‘un-Islamic’ vaccinations

http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/muslims-urged-to-refuse-unislamic-vaccinations-434027.html

Muslims urged to refuse ‘un-Islamic’ vaccinations
By Ruth Elkins
Sunday, 28 January 2007

A leading Islamic doctor is urging British Muslims not to vaccinate their children against diseases such as measles, mumps, and rubella because they contain substances making them unlawful for Muslims to take.

Dr Abdul Majid Katme, head of the Islamic Medical Association, says almost all vaccines contain un-Islamic “haram” derivatives of animal or human tissue, and that Muslim parents are better off letting childrens’ immune systems develop on their own.

Dr Katme, an NHS psychiatrist, said: “If you breastfeed your child for two years – as the Koran says – and you eat Koranic food like olives and black seed, and you do ablution each time you pray, then you will have a strong defence system.”

The Department of Health and the British Medical Association have criticised Dr Katme, saying his suggestions are likely to increase infection rates of children in Muslim communities. Other Muslim groups have also condemned the suggestion.

Muslim urged to shun ‘unholy’ vaccines

http://www.sherdog.net/forums/showthread.php?t=502697

The Sunday Times January 28, 2007

Muslim urged to shun ‘unholy’ vaccines
Abul Taher
A MUSLIM doctors’ leader has provoked an outcry by urging British Muslims not to vaccinate their children against diseases such as measles, mumps and rubella because it is “un-Islamic”.

Dr Abdul Majid Katme, head of the Islamic Medical Association, is telling Muslims that almost all vaccines contain products derived from animal and human tissue, which make them “haram”, or unlawful for Muslims to take.
Islam permits only the consumption of halal products, where the animal has had its throat cut and bled to death while God’s name is invoked.

Islam also forbids the eating of any pig meat, which Katme says is another reason why vaccines should be avoided, as some contain or have been made using pork-based gelatine.

His warning has been criticised by the Department of Health and the British Medical Association, who said Katme risked increasing infections ranging from flu and measles to polio and diphtheria in Muslim communities.

Katme, a psychiatrist who has worked in the National Health Service for 15 years, wields influence as the head of one of only two national Islamic medical organisations as well as being a member of the Muslim Council of Britain. Moderate Muslims are concerned at the potential impact because other Islamic doctors will have to confirm vaccines are derived from animal and human products.

There is already evidence of lower than average vaccination rates in Muslim areas, reducing the prospect of the “herd immunity” needed to curb infectious diseases such as measles, mumps and rubella.
Katme’s appeal reflects a global movement by some hardline Islamic leaders who are telling followers torefuse vaccines from the West.

In Nigeria, Afghanistan, Pakistan and parts of India, Muslims have refused to be immunised against polio after being told that the vaccines contain products that the West has deliberately added to make the recipients infertile.

Katme said he was bringing the message to Britain after analysing the products used for the manufacture of the vaccines. He claimed that Muslims must allow their children to develop their own immune system naturally rather than rely on vaccines.

He argued that leading “Islamically healthy lives” would be enough to ward off illnesses and diseases.

“You see, God created us perfect and with a very strong defence system. If you breast-feed your child for two years — as the Koran says — and you eat Koranic food like olives and black seed, and you do ablution each time you pray, then you will have a strong defence system,” he said.

“Many vaccines, especially those given to children, are full of haram substances — human parts, gelatine from pork, alcohol, animal/monkey parts, all coming from the West who do not have knowledge of halal or haram. It is forbidden in Islam to have any of these haram substances in our bodies.”

Katme singled out vaccines such as MMR as ones to avoid, despite doctors saying that they are essential to keep a baby healthy. Others included those for diphtheria, tetanus, acellular pertussis and meningitis.

Dr Shuja Shafi, a spokesman for the health and medical committee of the Muslim Council of Britain, said: “In terms of ingredients in vaccines, there are so many things that are probably haram, but in the absence of an alternative we are allowed to take it for the sake of our health.”

http://www.timesonline.co.uk/article…570067,00.html

Imunisasi Hepatitis A di Cina Memakan Korban

http://www.liputan6.com/luarnegeri/?id=104329

28/06/2005 18:00 Kesehatan
Imunisasi Hepatitis A di Cina Memakan Korban


Liputan6.com, Anhui: Imunisasi hepatitis A mengakibatkan sekitar 216 anak masuk rumah sakit. Salah seorang di antaranya tewas. Warga dari sebuah desa di Provinsi Anhui, Cina, ini menderita sakit kepala dan sesak napas pascavaksinasi hepatitis A, baru-baru ini. Sebagian besar vaksin itu didapatkan tim dokter dari seorang pedagang gelap yang sampai sekarang masih belum diketahui keberadaannya.

Biro Administrasi Obat-obatan setempat menduga, vaksin yang diberikan kepada anak-anak itu telah tercemar dan rusak. Sebab, temperaturnya tidak dijaga dalam perjalanan. Di samping itu, polisi menemukan indikasi korupsi biaya vaksinasi. Sebanyak 2.500 anak di 19 sekolah dipungut biaya empat kali lebih mahal dari seharusnya.

Sejauh ini, para dokter diduga terlibat dengan ikut menikmati bonus dari keuntungan yang dihasilkan. Polisi juga menemukan, beberapa dokter sebenarnya tidak memenuhi kualifikasi sebagai tenaga medis.(TNA/Nlg)

Cara Siti Fadilah Lawan Flu Burung

http://www.gatra.com/artikel.php?id=112817
Cara Siti Fadilah Lawan Flu Burung

Tamiflu Produksi Roche; Diborong (AP Photo/Ed Wray)Usaha keras tim medis Rumah Sakit Persahabatan, Jakarta Timur, tidak sia-sia. Lewat perawatan dan pengobatan intensif, selama kurang lebih satu bulan, Sania, 38 tahun, dan putrinya, Dewi Nurmiati, 14 tahun, dinyatakan sembuh dari penyakit flu burung, Kamis dua pekan lalu. Sebelumnya, dua warga Kampung Godang, Kalideres, Jakarta Barat, itu tergolek lemah di ruang perawatan isolasi pasien flu burung.

Ketua tim penanggulangan flu burung Rumah Sakit (RS) Persahabatan, Dokter Mukhtar Ikhsan, mengatakan bahwa mulanya pasien mengeluh sakit dengan gejala batuk-batuk dan gatal di tenggorokan yang disertai demam tinggi. Obat pereda flu yang diminum pada 24 Januari lalu tidak membuat penyakit itu menyingkir. Lalu pasien dibawa ke RS Persahabatan.

Di rumah sakit yang ditunjuk pemerintah sebagai rumah sakit rujukan bagi penderita flu burung itu, dokter mendiagnosis, pasien diduga terserang virus berkode H5N1 atau sering pula disebut virus avian influenza. Yakni virus yang penularannya melalui unggas.

Untuk memperkuat diagnosis, darah pasien yang sudah dinyatakan suspect flu burung tadi diperiksa. Hasilnya, positif mengandung H5N1. Selanjutnya perawatan dan pengobatan dilakukan. Termasuk memasang ventilator atau alat bantu pernapasan. Berangsur-angsur kondisi pasien membaik. Kini ibu dan anak itu bisa menjalani aktivitas sehari-hari. “Hasil pemeriksaan tes darah di laboratorium selama tiga hari berturut-turut menunjukkan, darah pasien negatif H5N1,” ujar Mukhtar.

Boleh dibilang, Sania dan Dewi sungguh beruntung. Mengacu pada data yang dikeluarkan Posko Flu Burung, Direktorat Jenderal Pengendalian Penyakit dan Penyehatan Lingkungan, Departemen Kesehatan (Ditjen P3L Depkes) pada 3 Februari lalu, di seantero Nusantara tercatat sebanyak 126 pasien yang dinyatakan positif flu burung. Usai dilakukan perawatan dan pengobatan, hanya 13 pasien atau kurang dari 10% yang berhasil sembuh. Selebihnya, 103 pasien atau hampir 90% dari total jumlah pasien meregang nyawa (lihat tabel).

Meski korban virus flu burung terus berjatuhan, ironisnya sampai saat ini belum ada obat mujarab yang sangup merontokkan virus mematikan itu. Memang ada obat Tamiflu atau oseltamivir untuk jenis generiknya. Tapi antivirus itu hanya berfungsi menekan perkembangan virus. Tamiflu akan efektif jika virus belum menyebar terlalu luas ke tubuh pasien. Atau sekurang-kurangnya 40 jam setelah pasien mengalami gejala terkena virus flu burung, seperti demam tinggi dan sesak napas.

Pencarian obat penawar virus flu burung ternyata telah lama menjadi perhatian serius pemerintah, khususnya Menteri Kesehatan, Siti Fadilah Supari. Sejak awal serangan virus flu burung di Indonesia terdeteksi, hingga merenggut korban jiwa Iwan Siswara pada Juli 2005, Siti Fadilah bertindak cepat. Langkah pertama yang dilakukan adalah mencegah penyebaran virus flu burung pada unggas. Ratusan unggas, seperti ayam, bebek, dan burung, yang diduga terjangkit virus flu burung, dimusnahkan dengan cara dibakar.

Langkah berikutnya, untuk menghadapi ancaman pandemi flu burung, Indonesia membutuhkan cadangan Tamiflu sedikitnya 10% dari jumlah penduduk yang mencapai 220 juta jiwa. Sehingga, kalau dihitung-hitung, pemerintah harus punya stok Tamiflu sebanyak 22 juta tablet.

Pemerintah pun menyiapkan dana sekitar Rp 200 milyar untuk membeli Tamiflu. Namun memenuhi kebutuhan sebanyak itu tidak mudah. Perusahaan farmasi, Roche, selaku produsen yang memegang hak paten Tamiflu, sedang kebanjiran pesanan.

Perusahaan farmasi yang berpusat di Swiss itu tidak hanya menerima pesanan dari Indonesia. Pesanan masuk dari hampir semua negara, tidak terkecuali Amerika Serikat. Negara adidaya yang belum punya kasus flu burung itu justru memborong Tamiflu dalam jumlah besar. Alasannya, buat stockpiling.

Gagal memesan ke Roche, Siti Fadilah tidak kehabisan akal. Ahli jantung dan pembuluh darah ini memerintahkan anak buahnya mencari Tamiflu hingga ke India. Negeri Mahatma Gandhi ini memiliki lisensi dari Roche untuk memproduksi oseltamivir, yakni tipe generiknya Tamiflu. Selain itu, Menter Kesehatan (Menkes) juga memerintahkan Indofarma menjadi pengimpor Tamiflu. Nantinya, perusahaan farmasi pelat merah ini diharapkan dapat segera memproduksi oseltamivir.

Penunjukan BUMN farmasi sebagai produsen obat flu burung itu diakui Indofarma. Menurut Direktur Produksi Indofarma, Yuliarti R. Merati, sejak 2005 Depkes menunjuk Indofarma untuk memproduksi oseltamivir. Namun baru mulai berproduksi berdasarkan pesanan Depkes pada 2006. “Hanya saja, pada 2007 belum ada pesanan lagi,” ujarnya.

Penat di benak Siti Fadilah belum mau beranjak. Selain masalah keterbatasan Tamiflu, perempuan kelahiran Solo, Jawa Tengah, itu dihadapkan pada persoalan ketidaktransparan sharing virus. Berdalih ada peraturan GISN (Global Influenza Surveillance Network), Indonesia diwajibkan menyerahkan sampel spesimen virus H5N1 ke Organisasi Kesehatan Dunia (WHO). Sampel itu dikirim ke laboratorium milik WHO CC (WHO-Collaborating Center) di Hong Kong.

Anehnya, meski virus berasal dari Indonesia, sebagai negara pemilik virus, Indonesia tidak pernah diberitahu tentang nasib virus tersebut. Apakah digunakan untuk penelitian pembuatan vaksin atau untuk penelitian pengembangan senjata biologis? Sejak terjadinya serangan flu burung, Indonesia telah mengirim 58 sampel virus. Namun, pada 20 Desember 2006, Siti Fadilah mengeluarkan kebijakan penghentian pengiriman sampel spesimen virus H5N1 ke WHO.

Keganjilan-keganjilan tadi mengusik nurani Siti Fadilah. Melalui buku berjudul Saatnya Dunia Berubah!, Menkes secara gamblang mengungkap suara kepedihan hatinya atas ketidakadlilan negara kaya dan WHO dalam kasus flu burung.

Soal pengiriman virus flu burung, misalnya, ia mendesak diberlakukannya MTA (material transfer agreement) atau kesepakatan pengiriman sampel virus. Isi MTA, antara lain, jika virus akan digunakan untuk keperluan komersial seperti pembuatan vaksin, negara pengirim harus ikut dilibatkan. Jika virus akan digunakan untuk pengembangan senjata biologis, negara pemilik virus punya hak veto untuk menolak.

Usulan Siti Fadilah itu dipicu fakta, virus H5N1 dari Indonesia yang dikirim ke laboratorium WHO CC, Hong Kong, ternyata diboyong ke Los Alamos National Laboratory di New Mexico, Amerika Serikat. Lab ini pernah digunakan untuk mengembangkan senjata biologis, antara lain bom atom yang diledakkan di Hiroshima dan Nagasaki, Jepang.

Lab yang berada di bawah Kementerian Energi Amerika Serikat itu diduga telah membuat data sequencing DNA virus H5N1 asal Indonesia. Diyakini, Los Alomos juga telah membuat seed virus yang lazim digunakan sebagai bahan baku pembuatan vaksin antivirus.

Buku yang dicetak dalam dua bahasa, Indonesia dan Inggris, itu sontak membuat gerah WHO dan Amerika Serikat. Melalui media Australia, The Age, pejabat WHO yang berwenang menangani flu burung, David Heymann, membantah tulisan Siti Fadilah yang dianggap memojokkan WHO itu. “Saya tidak mengerti, mengapa mereka (Los Alamos) akan membuat virus sebagai senjata biologis. (Virus) itu tidak menular dari manusia ke manusia,” kata Heymann.

Pemerintahan Bush ikut angkat bicara. Seperti dikutip The Age, juru bicara Departemen Luar Negeri Amerika Serikat, Susan Stahl, membantah tuduhan bahwa Los Alamos menyimpan virus flu burung asal Indonesia. “Laboratorium (Los Alamos) itu tidak memiliki virus flu burung dari Indonesia atau negara lainnya,” ujar Stahl.

Siti Fadilah Supari tetap pada pendiriannya. Menurut Siti Fadilah, apa yang ditulis dalam bukunya adalah fakta, bukan rekayasa, apalagi kebohongan. “Yang terjadi, orang yang berbohong malah bisa diterima. Ketika ada orang yang bicara apa adanya, justru dibenci,” kata Siti Fadilah kepada Syamsul Hidayat dari Gatra.

Jangan heran, Siti Fadilah melanjutkan, jika akhirnya orang berbohong hanya karena ingin dipuji banyak orang. “Biarlah mereka (WHO dan Amerika) tidak senang terhadap saya. Yang penting saya jujur, ngomong apa adanya,” ujar peraih gelar doktor dari Fakultas Kedokteran Universitas Indonesia itu.

Sujud Dwi Pratisto dan Aries Kelana
[Kesehatan, Gatra Nomor 17 Beredar Kamis, 6 Maret 2008]

Vaccine controversy – wikipedia

Vaccine controversy – wikipedia

http://en.wikipedia.org/wiki/Vaccine_controversy

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A vaccine controversy is a dispute over the morality, ethics, effectiveness, or safety of vaccination. Medical opinion is that the benefits of preventing suffering and death from infectious diseases greatly outweigh the risks of adverse effects following immunization.[1][2] Some vaccination critics say that vaccines are ineffective against disease[3], that vaccine safety studies are inadequate, or raise other objections.[2][3] Some religious groups oppose vaccination as a matter of doctrine,[4] and some political groups oppose mandatory vaccination on the grounds of individual liberty.[5]

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[edit] Arguments for

Rubella fell sharply when immunization was introduced. CDC

Rubella fell sharply when immunization was introduced. CDC

A number of arguments regarding the benefits of mass vaccination have been advanced:

[edit] Life-saving

Mass vaccination campaigns were essential components of strategies that led to the eradication of smallpox, which once killed as many as every seventh child in Europe,[6] and the near-eradication of polio.[7] As a more modest example, incidence of invasive disease with Haemophilus influenzae, a major cause of bacterial meningitis and other serious disease in children, has decreased by over 99% in the U.S. since the introduction of a vaccine in 1988.[8]

[edit] Cost

Vaccines are a cost-effective and preventive way of promoting health, compared to the treatment of acute or chronic disease. In the U.S. during the year 2001, routine childhood immunizations against seven diseases were estimated to save over $40 billion per birth-year cohort in overall health care and social costs, and the societal benefit-cost ratio for these vaccinations was estimated to be 16.5.[9]

[edit] Population health

Incomplete vaccine coverage increases the risk of disease for the entire population, including those who have been vaccinated. One study found that doubling the number of unvaccinated individuals would increase the risk of measles in vaccinated children anywhere from 5–30%.[10] A second study provided evidence that the risk of measles and pertussis increased in vaccinated children proportionally to the number of unvaccinated individuals among them, again highlighting the evident efficacy of widespread vaccine coverage for public health.[11]

[edit] Events following reductions in vaccination

In several countries since 1960, reductions in the use of some vaccines were followed by increases in the diseases’ morbidity and mortality.

Stockholm, smallpox (1873–74)

An anti-vaccination campaign motivated by religious objections, by concerns about effectiveness, and by concerns about individual rights, led to the vaccination rate in Stockholm dropping to just over 40%, compared to about 90% elsewhere in Sweden. A major smallpox epidemic then started in 1873. It led to a rise in vaccine uptake and an end of the epidemic.[12]

UK, DPT (1970s–80s)

A 1974 report ascribed 36 reactions to whooping cough (pertussis) vaccine, a prominent public-health academic claimed that the vaccine was only marginally effective and questioned whether its benefits outweigh its risks, and extended television and press coverage caused a scare. Vaccine uptake in the UK decreased from 81% to 31% and pertussis epidemics followed, leading to deaths of some children. Mainstream medical opinion continued to support the effectiveness and safety of the vaccine; public confidence was restored after the publication of a national reassessment of vaccine efficacy. Vaccine uptake then increased to levels above 90% and disease incidence declined dramatically.[13]

Sweden, pertussis (1979–96)

In the vaccination moratorium period that occurred when Sweden suspended vaccination against whooping cough (pertussis) from 1979 to 1996, 60% of the country’s children contracted the potentially fatal disease before the age of ten years; close medical monitoring kept the death rate from whooping cough at about one per year.[14] Pertussis continues to be a major health problem in developing countries, where mass vaccination is not practiced; the World Health Organization estimates it caused 294,000 deaths in 2002.[15]

Netherlands, measles (1999–2000)

An outbreak at a religious community and school in The Netherlands illustrates the effect of measles in an unvaccinated population.[16] The population in the several provinces affected had a high level of immunization with the exception of one of the religious denominations who traditionally do not accept vaccination. The three measles-related deaths and 68 hospitalizations that occurred among 2961 cases in the Netherlands demonstrate that measles can be severe and may result in death even in industrialized countries.

Ireland, measles (2000)

From late 1999 until the summer of 2000, there was a measles outbreak in North Dublin, Ireland. At the time, the national immunization level had fallen below 80%, and in part of North Dublin the level was around 60%. There were more than 100 hospital admissions from over 300 cases. Three children died and several more were gravely ill, some requiring mechanical ventilation to recover.[17][18]

Nigeria, polio, measles, diphtheria (2001 onward)

In the early 2000s, conservative religious leaders in northern Nigeria, suspicious of Western medicine, advised their followers to not have their children vaccinated with oral polio vaccine. The boycott was endorsed by the governor of Kano State, and immunization was suspended for several months. Subsequently, polio reappeared in a dozen formerly polio-free neighbors of Nigeria, and genetic tests showed the virus was the same one that originated in northern Nigeria: Nigeria had become a net exporter of polio virus to its African neighbors. People in the northern states were also reported to be wary of other vaccinations, and Nigeria reported over 20,000 measles cases and nearly 600 deaths from measles from January through March 2005.[19] In 2006 Nigeria accounted for over half of all new polio cases worldwide.[20] Outbreaks continued thereafter; for example, at least 200 children died in a late-2007 measles outbreak in Borno State.[21]

Indiana, measles (2005)

A 2005 measles outbreak in Indiana was due to children whose parents had refused to have them vaccinated.[22] Most cases of pediatric tetanus in the U.S. occur in children whose parents objected to their vaccination.[23]

[edit] Arguments against

Since the inception of vaccination in the late 18th century, opponents have argued that vaccines do not work, that they are dangerous, that individuals should rely on personal hygiene instead, or that mandatory vaccinations violate individual rights or religious principles.[5]

[edit] Effectiveness

Some vaccine critics claim that there have never been any benefits to public health from vaccination.[24][25] They argue that all the reduction of communicable diseases which were rampant in conditions where overcrowding, poor sanitation, almost non-existent hygiene and a yearly period of very restricted diet existed, are reduced because of changes in conditions excepting vaccination.[25] As discussed below, the philosophies of some alternative medicine practitioners are incompatible with the idea that vaccines are effective.[26]

Children who survive diseases like diphtheria develop a natural immunity that lasts longer than immunity developed via vaccination. Even though the overall mortality rate is much lower with vaccination, the percentage of adults protected against the disease may also be lower.[27] Vaccination critics argue that for diseases like diphtheria the extra risk to older or weaker adults may outweigh the benefit of lowering the mortality rate among the general population.[3]

[edit] Safety

Few deny the vast improvements vaccination has made to public health; a more common concern is their safety.[28] All vaccines may cause side effects, and immunization safety is a real concern. Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of saving children from tragic outcomes of common diseases.[1] Critics point out that lack of evidence of harm is not the same as evidence of safety.[3]

[edit] Auto-immune disorders

If individual or multiple vaccinations were to “weaken the immune system”, as some vaccine critics contend, then one would expect an increase in hospitalizations for other infections following immunization. A large epidemiological study, involving all 805,206 children born in Denmark between 1990 and 2001, found no evidence that multiple-antigen vaccines, nor the increasing number of vaccinations given to children, led to a higher rate of infections.[29]

A 2006 study of health data from the Canadian province of Ontario (where influenza vaccines have been free since 2000), found a correlation between receiving a vaccination and developing Guillain-Barré syndrome (GBS) in individuals, but no increase of GBS in the general population corresponding to vaccination popularity. The authors concluded, “individuals who receive the influenza vaccine should be advised of the potential risk for GBS”.[30]

[edit] Aluminum

Aluminum compounds are used in many vaccines as immunologic adjuvants, to stimulate the immune system and increase the response of the vaccine. Although these vaccines can elicit redness, itching, and low-grade fever,[31] and aluminum as such is considered neurotoxic for humans, its use in vaccines has not been associated with serious adverse events.[32] In some cases aluminum-containing vaccines are associated with macrophagic myofasciitis (MMF), localized microscopic lesions containing aluminum salts that persist up to 8 years. However, recent case-controlled studies have found no specific clinical symptoms in individuals with biopsies showing MMF, and there is no evidence that aluminum-containing vaccines are a serious health risk or justify changes to immunization practice.[32]

[edit] Thiomersal

The organic mercury content of thiomersal in child vaccines has been alleged to contribute to autism, and thousands of parents in the United States have pursued legal compensation from a federal fund.[33]

In July 1999, the Centers for Disease Control (CDC) and the American Academy of Pediatrics (AAP) asked vaccine makers to remove thiomersal from vaccines as quickly as possible, and thiomersal has been phased out of most U.S. and European vaccines.[34] However, the 2004 Institute of Medicine (IOM) panel favoured rejecting any causal relationship between thiomersal-containing vaccines and autism.[35] The CDC and the AAP followed the precautionary principle, which assumes that there is no harm in exercising caution even if it later turns out to be unwarranted, but their 1999 action sparked confusion and controversy that has diverted attention and resources away from efforts to determine the causes of autism.[34] The current scientific consensus is that there is no convincing scientific evidence that thiomersal causes or helps cause autism.[36]

[edit] MMR vaccine

In the UK, the MMR vaccine was the subject of controversy after publication of a 1998 paper by Andrew Wakefield, et al., reporting a study of 12 children mostly with autism spectrum disorders with onset soon after administration of the vaccine.[37] During a 1998 press conference, Wakefield suggested that giving children the vaccines in three separate doses would be safer than a single vaccination. This suggestion was not supported by the paper, and several subsequent peer-reviewed studies have failed to show any association between the vaccine and autism.[38] Wakefield has been heavily criticized on scientific grounds and for triggering a decline in vaccination rates,[39] as well as on ethical grounds for the way the research was conducted.[40]

In 2004 the MMR-and-autism interpretation of the paper was formally retracted by 10 of Wakefield’s 12 co-authors.[41] The CDC,[42] the IOM of the National Academy of Sciences,[43] and the UK National Health Service[44] have all concluded that there is no evidence of a link between the MMR vaccine and autism. A systematic review by the Cochrane Library concluded that there is no credible link between the MMR vaccine and autism, that MMR has prevented diseases that still carry a heavy burden of death and complications, that the lack of confidence in MMR has damaged public health, and that design and reporting of safety outcomes in MMR vaccine studies are largely inadequate.[2]

[edit] Prenatal infection

There is evidence that schizophrenia is associated with prenatal exposure to rubella, influenza, and toxoplasmosis infection. For example, one study found a seven-fold increased risk of schizophrenia when mothers were exposed to influenza in the first trimester of gestation. This may have public health implications, as strategies for preventing infection include vaccination, antibiotics, and simple hygiene.[45] When weighing the benefits of protecting the woman and fetus from influenza against the potential risk of vaccine-induced antibodies that could conceivably contribute to schizophrenia, influenza vaccination for women of reproductive age still makes sense, but it is not known whether vaccination during pregnancy helps or harms.[46] The CDC’s Advisory Committee on Immunization Practices, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians all recommend routine flu shots for pregnant women, for several reasons:[47]

  • their risk for serious influenza-related medical complications during the last two trimesters;
  • their greater rates for flu-related hospitalizations compared to nonpregnant women;
  • the possible transfer of maternal anti-influenza antibodies to children, protecting the children from the flu; and
  • several studies that found no harm to pregnant women or their children from the vaccinations.

Despite this recommendation, only 16% of healthy pregnant U.S. women surveyed in 2005 had been vaccinated against the flu.[47]

[edit] Individual liberty

Further information: Vaccination policy

Compulsory vaccination policies have provoked opposition at various times from people who say that governments should not infringe on the freedom of an individual to choose medications, even if the choice increases the risk of disease to others.[5][48] If a vaccination program successfully reduces the disease threat, it may reduce the perceived risk of disease enough so that an individual’s optimal strategy is to refuse vaccination at coverage levels below those optimal for the community.[49] If many exemptions are granted to mandatory vaccination rules, the resulting free rider problem may cause loss of herd immunity, substantially increasing risks even to vaccinated individuals.[50]

[edit] Religion

Vaccination has been opposed on religious grounds ever since it was introduced, even when vaccination is not compulsory. Early Christian opponents argued that if God had decreed that someone should die of smallpox, it would be a sin to thwart God’s will via vaccination.[4] Opposition continues to the present day, on various grounds. For example, the Family Research Council, a conservative U.S. Christian group, opposes mandatory vaccination for diseases typically spread via sexual contact, arguing that the possibility of disease deters sexual promiscuity.[51] Many governments allow parents to opt out of their children’s otherwise-mandatory vaccinations for religious reasons; some parents falsely claim religious beliefs to get vaccination exemptions.[52]

[edit] Alternative medicine

Many forms of alternative medicine are based on philosophies that oppose vaccination and have practitioners who voice their opposition. These include anthroposophy, some elements of the chiropractic community, non-medically trained homoeopaths, and naturopaths.[26]

Historically, chiropractic strongly opposed vaccination based on its belief that all diseases were traceable to causes in the spine, and therefore could not be affected by vaccines; Daniel D. Palmer, the founder of chiropractic, wrote, “It is the very height of absurdity to strive to ‘protect’ any person from smallpox or any other malady by inoculating them with a filthy animal poison.”[53] Vaccination remains controversial within chiropractic. The American Chiropractic Association and the International Chiropractic Association support individual exemptions to compulsory vaccination laws, and a 1995 survey of U.S. chiropractors found that about a third believed there was no scientific proof that immunization prevents disease.[54] The Canadian Chiropractic Association supports vaccination; however, surveys in Canada in 2000 and 2002 found that only 40% of chiropractors supported vaccination, and that over a quarter opposed it and advised patients against vaccinating themselves or their children.[53] Although most chiropractic writings on vaccination focus on its negative aspects,[53] antivaccination sentiment is espoused by what appears to be a minority of chiropractors.[54]

Several surveys have shown that some practitioners of homeopathy, particularly lay homeopaths, advise patients against vaccination.[55] For example, a survey of registered homeopaths in Austria found that only 28% considered immunization to be an important preventive measure, and 83% of homeopaths surveyed in Sydney, Australia did not recommend vaccination.[26] Many practitioners of naturopathy also oppose vaccination.[26]

[edit] Dispute resolution

Main article: Vaccine court

The U.S. Vaccine Injury Compensation Program (VICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death. It was established after a scare in the 1980s over the DPT vaccine: even though claims of side effects were later generally discredited, large jury awards had been given to some claimants of DPT vaccine injuries, and most DPT vaccine makers had ceased production. Claims against vaccine manufacturers must be heard first in the vaccine court.[33] By 2008 the fund had paid out 2,114 awards totaling $1.7 billion.[56] Thousand of autism-related claims are pending before the court, and have not yet been resolved.[33]

[edit] History of anti-vaccinationism

Portrait of Jenner

Portrait of Jenner

After the work of Edward Jenner, vaccination became widespread in the United Kingdom in the early 1800s.[57] Variolation, which had preceded vaccination, was banned in 1840 because of its greater risks. Public policy and successive Vaccination Acts first encouraged vaccination and then made it mandatory, with the highest penalty for refusal being a prison sentence. This was a significant change in the relationship between the British state and its citizens, and there was a public backlash. Initially this was focused against compulsory vaccination, and later included arguments that vaccination was dangerous and ineffective.

In the 19th century, the city of Leicester in the UK achieved a high level of isolation of smallpox cases and great reduction in spread compared to other areas. The mainstay of Leicester’s approach to conquering smallpox was to decline vaccination and put their public funds into sanitary improvements.[58][59] Bigg’s account of the public health procedures in Leicester, presented as evidence to the Royal Commission, refers to erysipelas, an infection of the superficial tissues which was a complication of any surgical procedure.

In the U.S., President Thomas Jefferson took a close interest in vaccination, alongside Dr. Waterhouse, chief physician at Boston. Jefferson encouraged the development of ways to transport vaccine material through the Southern states, which included measures to avoid damage by heat, a leading cause of ineffective batches. Smallpox outbreaks were contained by the latter half of the 19th century, a development widely attributed to vaccination of a large portion of the population.[60] Vaccination rates fell after this decline in smallpox cases, and the disease again became epidemic in the 1870s (see smallpox).

Anti-vaccination activity increased again in the U.S. in the late 19th century. After a visit to New York in 1879 by William Tebb, a prominent British anti-vaccinationist, the Anti-Vaccination Society of America was founded. The New England Anti-Compulsory Vaccination League was formed in 1882, and the Anti-Vaccination League of New York City in 1885.

The first arguments against vaccination were theological.[4] Some anti-vaccinationists still base their stance against vaccination with reference to the Bible.[61] In the early 19th century, the anti-vaccination movement drew members from across a wide range of society; more recently, it has been reduced to a predominantly middle-class phenomenon.[62] Arguments made against the safety and effectiveness of vaccines in the 21st century are similar to those of the early anti-vaccinationists.[5]

[edit] References

  1. ^ a b Bonhoeffer J, Heininger U (2007). “Adverse events following immunization: perception and evidence”. Curr Opin Infect Dis 20 (3): 237–46. doi:10.1097/QCO.0b013e32811ebfb0. PMID 17471032.
  2. ^ a b c Demicheli V, Jefferson T, Rivetti A, Price D (2005). “Vaccines for measles, mumps and rubella in children”. Cochrane Database Syst Rev 19 (4). doi:10.1002/14651858.CD004407.pub2. PMID 16235361. Lay summaryCochrane press release (PDF) (200510-19).
  3. ^ a b c d Halvorsen R (2007). The Truth about Vaccines. Gibson Square. ISBN 9781903933923.
  4. ^ a b c White AD (1896). “Theological opposition to inoculation, vaccination, and the use of anæsthetics“, A History of the Warfare of Science with Theology in Christendom. New York: Appleton. Retrieved on 200708-17.
  5. ^ a b c d Wolfe R, Sharp L (2002). “Anti-vaccinationists past and present“. BMJ 325 (7361): 430–2. doi:10.1136/bmj.325.7361.430. PMID 12193361.
  6. ^ Fenner F, Henderson DA, Arita I, Ježek Z, Ladnyi, ID (1988). Smallpox and its Eradication (PDF), Geneva: World Health Organization. ISBN 92-4-156110-6. Retrieved on 200709-04.
  7. ^ Sutter RW, Maher C (2006). “Mass vaccination campaigns for polio eradication: an essential strategy for success”. Curr Top Microbiol Immunol 304: 195–220. PMID 16989271.
  8. ^ Centers for Disease Control and Prevention (CDC) (2002). “Progress toward elimination of Haemophilus influenzae type b invasive disease among infants and children—United States, 1998–2000“. MMWR Morb Mortal Wkly Rep 51 (11): 234–7. PMID 11925021.
  9. ^ Zhou F, Santoli J, Messonnier ML et al. (2005). “Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001“. Arch Pediatr Adolesc Med 159 (12): 1136–44. PMID 16330737.
  10. ^ Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, Chen RT (1999). “Health consequences of religious and philosophical exemptions from immunization laws: individual and societal risk of measles”. JAMA 282 (1): 47–53. PMID 10404911.
  11. ^ Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE (2000). “Individual and community risks of measles and pertussis associated with personal exemptions to immunization”. JAMA 284 (24): 3145–50. PMID 11135778.
  12. ^ Nelson MC, Rogers J (1992). “The right to die? Anti-vaccination activity and the 1874 smallpox epidemic in Stockholm”. Soc Hist Med 5 (3): 369–88. PMID 11645870.
  13. ^ Gangarosa EJ, Galazka AM, Wolfe CR et al. (1998). “Impact of anti-vaccine movements on pertussis control: the untold story”. Lancet 351 (9099): 356–61. doi:10.1016/S0140-6736(97)04334-1. PMID 9652634.
  14. ^ Allen A (2002). “Bucking the herd“. The Atlantic 290 (2): 40–2. Retrieved on 200711-07.
  15. ^ Centers for Disease Control and Prevention (2007). “Pertussis“, in Atkinson W, Hamborsky J, McIntyre L, Wolfe S: Epidemiology and Prevention of Vaccine-Preventable Diseases. Washington, DC: Public Health Foundation.
  16. ^ Centers for Disease Control and Prevention (2000). “Measles outbreak—Netherlands, April 1999–January 2000“. MMWR Morb Mortal Wkly Rep 49 (14): 299–303. PMID 10825086.
  17. ^Measles outbreak feared“, BBC News, 30 May 2000. Retrieved on 200711-23.
  18. ^ McBrien J, Murphy J, Gill D, Cronin M, O’Donovan C, Cafferkey M (2003). “Measles outbreak in Dublin, 2000”. Pediatr Infect Dis J 22 (7): 580–4. PMID 12867830.
  19. ^ Clements CJ, Greenough P, Schull D (2006). “How vaccine safety can become political – the example of polio in Nigeria” (PDF). Curr Drug Saf 1 (1): 117–9.
  20. ^ Wild poliovirus 2000–2008 (PDF). Global Polio Eradication Initiative (200802-05). Retrieved on 200802-11.
  21. ^‘Hundreds’ dead in measles outbreak“, IRIN, 200712-14. Retrieved on 200802-10.
  22. ^ Parker A, Staggs W, Dayan G et al. (2006). “Implications of a 2005 measles outbreak in Indiana for sustained elimination of measles in the United States”. N Engl J Med 355 (5): 447–55. PMID 16885548.
  23. ^ Fair E, Murphy TV, Golaz A, Wharton M (2002). “Philosophic objection to vaccination as a risk for tetanus among children younger than 15 years“. Pediatrics 109 (1): e2. PMID 11773570.
  24. ^ Dr. med. Gerhard Buchwald (Ref: The Vaccination Nonsense. ISBN 3-8334-2508-3 page 108. Asserts that vaccination has never provided any benefit.
  25. ^ a b Morrell, Peter (October 13, 2000). eLetters: Vaccination: the wider picture?. Canadian Medical Association Journal. Retrieved on 200711-23.
  26. ^ a b c d Ernst E (2001). “Rise in popularity of complementary and alternative medicine: reasons and consequences for vaccination”. Vaccine 20 (Suppl 1): S89–93. doi:10.1016/S0264-410X(01)00290-0. PMID 11587822.
  27. ^ Galazka AM, Robertson SE (1995). “Diphtheria: changing patterns in the developing world and the industrialized world”. Eur J Epidemiol 11 (1): 107–17. PMID 7489768.
  28. ^ The Lancet Infectious Diseases (2007). “Tackling negative perceptions towards vaccination”. Lancet Infect Dis 7 (4): 235. doi:10.1016/S1473-3099(07)70057-9. PMID 17376373.
  29. ^ Hviid A, Wohlfahrt J, Stellfeld M, Melbye M (2005). “Childhood vaccination and nontargeted infectious disease hospitalization”. JAMA 294 (6): 699–705. PMID 16091572.
  30. ^ Juurlink DN, Stukel TA, Kwong J, et al (2006). “Guillain-Barré syndrome after influenza vaccination in adults: a population-based study”. Arch. Intern. Med. 166 (20): 2217–21. doi:10.1001/archinte.166.20.2217. PMID 17101939.
  31. ^ Baylor NW, Egan W, Richman P (2002). “Aluminum salts in vaccines—US perspective”. Vaccine 20 (Suppl 3): S18–23. doi:10.1016/S0264-410X(02)00166-4. Corrigendum (2002). Vaccine 20 (27–8): 3428. doi:10.1016/S0264-410X(02)00307-9 PMID 12184360.
  32. ^ a b François G, Duclos P, Margolis H et al. (2005). “Vaccine safety controversies and the future of vaccination programs”. Pediatr Infect Dis J 24 (11): 953–61. PMID 16282928.
  33. ^ a b c Sugarman SD (2007). “Cases in vaccine court—legal battles over vaccines and autism“. N Engl J Med 357 (13): 1275–7. PMID 17898095.
  34. ^ a b Offit PA (2007). “Thimerosal and vaccines—a cautionary tale“. N Engl J Med 357 (13): 1278–9.
  35. ^ Immunization Safety Review Committee (2004). Immunization Safety Review: Vaccines and Autism. The National Academies Press. ISBN 0-309-09237-X.
  36. ^ Doja A, Roberts W (2006). “Immunizations and autism: a review of the literature”. Can J Neurol Sci 33 (4): 341–6. PMID 17168158.
  37. ^ Wakefield A, Murch S, Anthony A et al. (1998). “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children“. Lancet 351 (9103): 637–41. doi:10.1016/S0140-6736(97)11096-0. PMID 9500320. Retrieved on 200709-05.
  38. ^ National Health Service (2004). MMR: myths and truths. Retrieved on 200709-03.
  39. ^Doctors issue plea over MMR jab“, BBC News, 200606-26. Retrieved on 200711-23.
  40. ^MMR scare doctor ‘paid children’“, BBC News, 200707-16. Retrieved on 200711-23.
  41. ^ Murch SH, Anthony A, Casson DH et al. (2004). “Retraction of an interpretation”. Lancet 363 (9411): 750. doi:10.1016/S0140-6736(04)15715-2. PMID 15016483.
  42. ^ Autism and Vaccines Theory, from the U.S. Centers for Disease Control. Accessed June 13, 2007.
  43. ^ Immunization Safety Review: Vaccines and Autism. From the Institute of Medicine of the National Academy of Sciences. Report dated May 17, 2004; accessed June 13, 2007.
  44. ^ MMR Fact Sheet, from the United Kingdom National Health Service. Accessed June 13, 2007.
  45. ^ Brown AS (2006). “Prenatal infection as a risk factor for schizophrenia“. Schizophr Bull 32 (2): 200–2. doi:10.1093/schbul/sbj052. PMID 16469941.
  46. ^ Arehart-Treichel J (2007). “Schizophrenia risk factor found in maternal blood“. Psychiatr News 42 (3): 22.
  47. ^ a b Fiore AE, Shay DK, Haber P et al. (2007). “Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007“. MMWR Recomm Rep 56 (RR-6): 1-54.
  48. ^ Colgrove J, Bayer R (2005). “Manifold restraints: liberty, public health, and the legacy of Jacobson v Massachusetts“. Am J Public Health 95 (4): 571–6. doi:10.2105/AJPH.2004.055145. PMID 15798111.
  49. ^ Fine PE, Clarkson JA (1986). “Individual versus public priorities in the determination of optimal vaccination policies”. Am J Epidemiol 124 (6): 1012–20. PMID 3096132.
  50. ^ May T, Silverman RD (2005). “Free-riding, fairness and the rights of minority groups in exemption from mandatory childhood vaccination” (PDF). Hum Vaccin (1): 12–5. PMID 17038833.
  51. ^ Fortson D. “Moral majority take on GSK and Merck over cancer drugs“, The Independent, 200606-11. Retrieved on 200611-02.
  52. ^ LeBlanc S. “Parents use religion to avoid vaccines“, USA Today, 200710-17. Retrieved on 200711-24.
  53. ^ a b c Busse JW, Morgan L, Campbell JB (2005). “Chiropractic antivaccination arguments”. J Manipulative Physiol Ther 28 (5): 367–73. doi:10.1016/j.jmpt.2005.04.011. PMID 15965414.
  54. ^ a b Campbell JB, Busse JW, Injeyan HS (2000). “Chiropractors and vaccination: a historical perspective“. Pediatrics 105 (4): e43. PMID 10742364.
  55. ^ Schmidt K, Ernst E (2003). “MMR vaccination advice over the Internet”. Vaccine 21 (11-12): 1044-7. PMID 12559777.
  56. ^ National Vaccine Injury Compensation Program statistics reports. Health Resources and Services Administration (200801-08). Retrieved on 200801-22.
  57. ^ Ellner P (1998). “Smallpox: gone but not forgotten.”. Infection 26 (5): 263–9. PMID 9795781.
  58. ^ Eddy TP (1992). “The Leicester anti-vaccination movement”. Lancet 340 (8830): 1298. PMID 1359363.
  59. ^ Fourth and other reports of the Royal Commission into smallpox and Leicester 1871 et seq
  60. ^ (U.S.) Center for Disease Control
  61. ^ Vaccination – A Crime Against Humanity. The Associated Jehovah’s Witnesses for Reform on Blood. Retrieved on 200611-02.
  62. ^ Fitzpatrick M (2005). “The anti-vaccination movement in England, 1853–1907”. J R Soc Med 98 (8): 384–5.

[edit] Further reading

Anti-vaccinationist publications
  • 1884 Compulsory Vaccination in England by William Tebb
  • 1885 The Story of a Great Delusion by William White
  • 1898 Vaccination A Delusion by Alfred Russel Wallace
  • 1936 The Case Against Vaccination by M. Beddow Bayly M.R.C.S., L.R.C.P.
  • 1951 The Truth About Vaccination and Immunization by Lily Loat
  • 1957 The Poisoned Needle by Eleanor McBean
  • 1990 Universal Immunization: Miracle or Masterful Mirage by Dr. Raymond Obomsawin
  • 1993 Vaccination: 100 years of orthodox research shows that vaccines represent an assault on the immune system by Viera Scheibner. ISBN 0-646-15124-X
  • 2000 Behavioural Problems in Childhood by Viera Scheibner. ISBN 0-9578007-0-3

[edit] External links

Nigella sativa – Wikipedia

Nigella sativa

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Nigella sativa
Nigella sativa (left) and Nigella damascena (right)

Nigella sativa (left) and Nigella damascena (right)
Scientific classification
Kingdom: Plantae
Division: Magnoliophyta
Class: Magnoliopsida
Order: Ranunculales
Family: Ranunculaceae
Genus: Nigella
Species: N. sativa
Binomial name
Nigella sativa
L.

Nigella sativa is an annual flowering plant, native to southwest Asia. It grows to 20–30 cm tall, with finely divided, linear (but not thread-like) leaves. The flowers are delicate, and usually coloured pale blue and white, with 5–10 petals. The fruit is a large and inflated capsule composed of 3–7 united follicles, each containing numerous seeds. The seed is used as a spice.

Nigella sativa seed

Nigella sativa seed

In English, Nigella sativa seed is variously called fennel flower, nutmeg flower, Roman coriander, blackseed, black caraway, or black onion seed. Other names used, sometimes misleadingly, are onion seed and black sesame, both of which are similar-looking but unrelated. The seeds are frequently referred to as black cumin (as in Bengali কালো জিরা kalo jira), but this is also used for a different spice, Bunium persicum. The scientific name is a derivative of Latin niger “black”.[1] An older English name gith is now used for the corncockle. In English-speaking countries with large immigrant populations, it is also variously known as kalonji (Hindi कलौंजी kalauṃjī or कलोंजी kaloṃjī), kezah Hebrew קצח), chernushka (Russian), çörek otu (Turkish), habbat albarakah (Arabic حبه البركة ḥabbatu l-barakah “seed of blessing”) or siyah daneh (Persian سیاه‌دانه siyâh dâne).

A commercial pack of kalonji

A commercial pack of kalonji

This potpourri of vernacular names for this plant reflects that its widespread use as a spice is relatively new in the English speaking world[citation needed], and largely associated with immigrants from areas where it is well known. Increasing use is likely to result in one of the names winning out, hopefully one which is unambiguous.

Nigella sativa has a pungent bitter taste and a faint smell of strawberries. It is used primarily in candies and liquors. The variety of naan bread called Peshawari naan is as a rule topped with kalonji seeds. In herbal medicine, Nigella sativa has hypertensive, carminative, and anthelminthic properties[citation needed]. They are eaten by elephants to aid digestion.[citation needed]

Contents

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[edit] Historical accounts

According to Zohary and Hopf, archeological evidence about the earliest cultivation of N. sativa “is still scanty”, but they report that N. sativa seeds have been found in several sites from ancient Egypt, including Tutenkhamen‘s tomb.[1] Although its exact role in Egyptian culture is unknown, it is known that items entombed with a pharaoh were carefully selected to assist him in the after life.

The earliest written reference to N. sativa is thought to be in the book of Isaiah in the Old Testament where the reaping of nigella and wheat is contrasted (Isaiah 28: 25, 27). Easton’s Bible dictionary states that the Hebrew word ketsah refers to without doubt to N. sativa (although not all translations are in agreement). According to Zohary and Hopf, N. sativa “was another traditional condiment of the Old World during classical times; and its black seeds were extensively used to flavour food.”[1]

[edit] Use in folk medicine

Nigella sativa has been used for medicinal purposes for centuries, both as a herb and pressed into oil, in Asia, Middle East, and Africa. It has been traditionally used for a variety of conditions and treatments related to respiratory health, stomach and intestinal health, kidney and liver function, circulatory and immune system support, and for general well-being.

In Islam, it is regarded as one of the greatest forms of healing medicine available. Prophet Muhammad once stated that the black seed can heal every disease—except death—as recounted in the following hadith:

Narrated Khalid bin Sa’d:We went out and Ghalib bin Abjar was accompanying us. He fell ill on the way and when we arrived at Medina he was still sick. Ibn Abi ‘Atiq came to visit him andsaid to us, “Treat him with black cumin. Take five or seven seeds and crush them (mix the powder with oil) and drop the resulting mixture into both nostrils, for ‘Aisha has narrated to me that she heard the Prophet saying, ‘This black cumin is healing for all diseases except As-Sam.’ ‘Aisha said, ‘What is As-Sam?’ He said, ‘Death.’ ” (Bukhari)

Ibn Sina, most famous for his volumes called The Canon of Medicine, refers to nigella as the seed that stimulates the body’s energy and helps recovery from fatigue and dispiritedness. It is also included in the list of natural drugs of ‘Tibb-e-Nabavi’, or “Medicine of the Prophet (Muhammad)”, according to the tradition “hold onto the use of the black seeds for in it is healing for all diseases except death” (Sahih Bukhari vol. 7 book 71 # 592).

In the Unani Tibb system of medicine, N. sativa is regarded as a valuable remedy for a number of diseases.

The seeds have been traditionally used in the Middle East and Southeast Asian countries to treat ailments including asthma, bronchitis, rheumatism and related inflammatory diseases, to increase milk production in nursing mothers, to promote digestion and to fight parasitic infections. Its oil has been used to treat skin conditions such as eczema and boils and to treat cold symptoms. Its many uses have earned nigella the Arabic approbation ‘Habbatul barakah’, meaning the seed of blessing.

[edit] Scientific studies

Black cumin oil contains nigellone, which protects guinea pigs from histamine-induced bronchial spasms[citation needed] (perhaps explaining its use to relieve the symptoms of asthma, bronchitis, and coughing).

The presence of an anti-tumor sterol, beta sitosterol, lends credence to its traditional use to treat abscesses and tumors of the abdomen, eyes, and liver.[2]

[edit] As an anti-parasitic

Anticestodal effect of N. sativa seeds was studied in children naturally infected with the respective worm. A single oral administration of 40 mg/kg of N. sativa seeds and equivalent amount of its ethanolic extract were effective in reducing the egg count in the faeces, with a comparable effect to niclosamide. The crude extracts also did not produce any adverse side effects from all the doses tested.[3]

In 1998, Korshom et al. investigated the anti-trematodal activity of N.sativa seeds against a ruminant fluke (Paramphistomum) in sheep.[4] The methanol extract (1 ml/kg) and powder (200 mg/kg) showed high efficacy, comparable to Hapadex (netobimin, 20 mg/kg). (NOTE: methanol is transformed in the body to formaldehyde, and such raw extracts would not be used in a formulated product.)

In 2005, Azza et al. studied the anti-schistosomicidal properties of aqueous extract of N. sativa seeds against Schistosoma mansoni miracidia, cercariae, and the adult worms in vitro. It showed strong biocidal effects against all stages of the parasite and also inhibited egg-laying of adult female worms. [5]

In 2007, Abdulelah and Zainal-Abidin investigated the anti-malarial activities of different extracts of N.sativa seeds against P. berghei. Results indicated strong biocidal effects against the parasite.[6][7]

[edit] See also

[edit] References

  1. ^ a b (2000) Domestication of plants in the Old World, 3, Oxford University Press, p. 206. ISBN 0198503563.
  2. ^ Look for sterols at http://glycoscience.org/glycoscience/linksPage/links.html Click on the 4th listing for the GlycoScience link. (Link is dead of 2008-1-12)
  3. ^ Akhtar, M.S. & Rifaat, S. 1991. Field trial of Saussurea lappa roots against nematodes and Nigella sativa seeds against cestodes in children. Journal of the Pakistan Medical Association 41: 185–187.
  4. ^ Korshom M., Moghney, A.A. & Mandour, A. 1998. Biochemical and parasitological evaluation of Nigella sativa against ruminant fluke (Paramphistomum) in sheep as compared with trematocide “Hapadex”. Assiut. Vaternary Med. J. 39 (78): 238–244.
  5. ^ Azza, M. M., Nadia, M. M. & Sohair, S. M. 2005. Sativa seeds against Schistosoma mansoni different stages. Mem. Inst. Oswaldo. Cruz. Rio de Janeiro 100(2): 205–211.
  6. ^ Abdulelah H.A.A. & Zainal-Abidin B.A.H. 2007. In vivo anti-malarial tests of Nigella sativa (black seed) different extracts. American Journal of Pharmacology and Toxicology 2 (2): 46-50, 2007.
  7. ^ Abdulelah H.A.A. & Zainal-Abidin B.A.H. 2007. Curative and prophylactic anti-malarial activities of Nigella sativa (black seed) in mice. Malaysian Journal of Medical Sciences 14: 209.

[edit] External links

EFEK SPIRULINA (Ganggang Biru Hijau) PADA KEKEBALAN

EFEK SPIRULINA (Ganggang Biru Hijau) PADA KEKEBALAN

http://www.blue-green-algae.org/blue-green-algae.html

Thus, multiple studies on whole blue-green-algae in humans, mice, rats, cats, and chickens have demonstrated an effect on phagocytosis, NK cell function, and inflamma­tion. Some differences exist in the data, including the mild reduction of phagocytic activity in humans after algae con­sumption, in contrast to the increase of phagocytosis among bronchoalveolar macrophages. The cell types and experimental set-ups vary, and further studies are needed to estab­lish the exact biochemical mechanisms involved.

EFFECTS OF BLUE-GREEN ALGAE ON SPECIFIC IMMUNITY
Hayashi et al7 examined the effect of an algae-supple-mented diet on the ability to build a specific immune response

Table 2. Immuno-Modulatory and Anti-Inflammatory Effects of Whole Blue-Green Algae

Algae Species

Introduced as:

Test Species

Effects Reference
Spirulina sp. Food Human Reversal of tobacco-induced oral cancer Mathew et al, 1995
Food Mouse Proportional reduction of IgE, increase of IgA Hayashi et al, 1998
Food Mouse Increased phagocytic activity Increased spleen cell proliferation Increased antibody production Hayashi et al, 1994
Food Chicken Increased phagocytic activity Increased NK cell-mediated anti-tumor activity Increased antibody production Qureshi et al, 1996
Extract

In vitro, cat

Increased phagocytic activity

Qureshi & Ali, 1996

IP injection Rat Inhibition of mast cells Decrease in local allergic reaction Decrease in serum histamine levels Reduced allergy-induced mortality Kim et al, 1998 Yang et al, 1997
Aphanizomenon flos-aquae Food Human Increased transient recruitment of NK cells into tissue Increased mobilization of T and B cells into blood Mild modulation of PMN-mediated phagocytic response Jensen et al, 2000
Food Rat Decreased serum levels of arachidonic acid Kushak et al, 2000
Food Rat Source of linolenic acid (omega-3) Increased serum levels of EPA and DHA Kushak et al, 2000
Extract

In vitro, rat

Activation of macrophages (NF-kappaB, cytokines) Pasco, in press

to sheep red blood cells. After immunizing mice (either once to measure the primary response or twice for the secondary response), they found that mice fed with the algae-supple-mented diet showed increased numbers of splenic IgM anti-body-producing cells when compared to control animals. Interestingly, this finding only held true for the primary immune response, as the IgG antibody production in the sec­ondary immune response was hardly affected. In experiments involving chickens, there were no differences observed in anti-sheep red blood cell antibodies during primary responses, while antibody titers for the secondary response in algae-fed chickens were augmented compared to control animals.8 The differences may reflect the anatomical differences between the rodent and chicken immune systems.

Hayashi et al10 examined other antibody classes such as IgA and IgE in the context of mice orally immunized with a crude shrimp extract. They found that whereby both IgA (intestinal) and IgE (in serum) levels increased with antigen challenge, only IgA levels showed a greater enhancement in secretion with concurrent treatment with Spirulina extract (five-week feeding regimen).10 From this study they con­cluded that bluegreen algae does not seem to induce or enhance food allergic IgE-dependent reactions.  Furthermore, they suggest that when ingested along with or before a poten­tial antigenic threat, bluegreen algae may enhance IgA anti- body levels to protect against food allergies.

Along the same lines, further studies have suggested that blue-green algae may inhibit mast cell-mediated type I aller­gic reactions and even the anaphylactic reaction in rats.11,12 By injecting a blue-green algae extract intraperitoneally (100-1000mg/g body weight) one hour prior to an allergic challenge, mortality induced by the anaphylactic compound 48/80 was decreased, local allergic reaction activated by anti­dinitrophenyl (anti-DNP) IgE was inhibited, and serum hist­amine levels were decreased. In vitro experiments from this group provided similar results.

The effects of blue-green-algae on IgE-production and allergic reactions are encouraging, and warrant further studies in humans.

EFFECTS OF BLUE-GREEN ALGAE ON LEUKOCYTE TRAFFICKING
Much attention with regards to dietary modulation of the immune system has been given to stimulating activity of various immune cell types such as the phagocytic activity of macrophages, or the tumoricidal activity of natural killer cells. However, immune cell trafficking and the recruitment of immune cells from the systemic circulation are of equal importance. A recent study by Jensen et al5 involving

Table 3. Bio-modulatory Effects of Purified Compounds from Blue-Green Algae

Species Compound Effects References
All blue-green algae C-Phycocyanin Anti-inflammatory (reduces leukotriene B4) Free radical scavenger Selective inhibition of COX-2 Reduced tissue damage in acetic acid-induced colitis Hepatoprotective effect Romay 1999 Bhat & Madyastha 2000 Reddy et al, 2000 Gonzalez et al, 1999 Vadiraja et al, 1998
Spirulina Calcium Spirulan (Ca-Sp) Selectively inhibits penetration of virus into host cell (Herpex Simplex, human cytomegalovirus, measles, mumps, Influenza A, HIV-1) Hayashi et al, 1996
Reduces lung metastasis of melanoma cells by inhibition of tumor cell invasion of basal membrane Mishima et al, 1998
Cyanovirin-N Irreversible inactivation of several strains of HIV (inhibited cell-to-cell and virus-to-cell fusion) Boyd, 1997

Extracellular products

Promotion of lactic acid bacteria growth in vitro Parada et al, 1998
Aphanizomenon flos aquae Unknown Polysaccharide Induces apoptosis in some human tumor cell lines Stimulate the macrophage activity Jensen, msp in prep Pasco et al, in press.
Lyngbya lagerheimii Phormidium tenue Sulfolipid Inhibits syncytium formation upon HIV infection Gustafson et al, 1989
Phormidium tenue

Digalactosyl diacylglycerols

Inhibition of chemically induced skin tumors Tokuda et al, 1996

humans demonstrated that the blue-green alga Aphanizomenon flos-aquae was able to trigger within two hours the migra­tion of nearly 40% of the circulating natural killer cells. This effect was significantly more pronounced in long-term consumers than in naïve subjects. In the same study, Aphanizomenon flos-aquae was also shown to stimulate the mobilization of T and B lymphocytes. This effect appeared cell-type specific since no changes were observed on poly­morph nucleated cells.

ANTI-INFLAMMATORY PROPERTIES OF BLUE­GREEN ALGAE
Blue-green algae in general contain a significant amount of carotenoids, namely beta carotene, lycopene, and lutein, providing it with good antioxidant properties. By their quenching action on reactive oxygen species, antioxi­dants carry intrinsic anti-inflammatory properties. However, blue green algae also contains specific anti­inflammatory properties as a result of their high phyco­cyanin content. Phycocyanin is a photoharvesting pigment that provides the intense blue color in blue green algae. It can constitute up to 15% of the dry weight of a blue green algae harvest. C-phycocyanin is a free radical scavenger,26 and has significant hepatoprotective effects.27 Phycocyanin was shown to inhibit inflammation in mouse ears28 and pre-tory effect seemed to be a result of phycocyanin to inhibit the formation of leukotriene B4, an inflammatory metabo­lite of arachidonic acid.28

In a study performed in rats, the blue-green algae Aphanizomenon flos-aquae was also shown to decrease the plasma level of arachidonic acid.30 Aphanizomenon flos­aquae contains significant amounts of the omega-3 alpha-linolenic acid. Omega-3 fatty acids have been shown to inhibit the formation of inflammatory prostaglandins and arachidonate metabolites. Since Spirulina contains signifi­cant amounts of omega-6 gamma-linolenic acid, the anti­inflammatory properties of Spirulina must be due to differ­ent biochemical pathways.

ANTI-VIRAL EFFECTS
As part of its program aimed at discovering new anti­tumor and anti-viral agents in natural sources, the National Cancer Institute isolated extracts of blue-green algae (Lyngbya lagerheimii and Phormidium tenue) that were found to protect human lymphoblastoid T cells from the cytopathic effect of HIV infection.  Upon further investigation, a new class of HIV inhibitory compounds called the sulfonic acid-containing glycolipids were isolated; the pure compounds were found to be strikingly active against the HIV virus in the p24 viral protein and syncytium formation assays.13 Since this discovery, there has been further investigation into other species of blue-green algae for compounds with anti-viral properties. Some compounds worthy of mention include a protein called cyanovirin-N which appears to irreversibly inactivate diverse strains of the HIV virus and to inhibit cell-to-cell and virus-to-cell fusion.14 Other studies using a water-soluble extract of blue-green algae have found a novel sulfat­ed polysaccharide, calcium spirulan (Ca-SP), to be an antivi­ral agent. This compound appears to selectively inhibit the penetration of enveloped viruses (Herpes simplex, human cytomegalovirus, measles virus, mumps virus, influenza A virus, and HIV-1) into host cells, thereby preventing replica-tion.15-17 A review of anti-HIV activity of extracts from blue-green algae has been recently published.18

ANTI-CANCER EFFECTS
An early study on bluegreen algae’s cancer-preventive properties in humans was performed on tobacco-induced oral leukoplakia.19 Mathew et al found that oral supplemen­tation with Spirulina fusiformis resulted in complete regres­sion of 57% of subjects with homogenous leukoplakia. After discontinuation of Spirulina supplementation, almost half of the complete responders developed recurrent lesions.

In other studies, extracts of bluegreen algae have been used to treat cancer in animal models. In one model, inges­tion of an extract of Spirulina and Dunaliella was shown to inhibit chemically-induced carcinogenesis in hamster buc­cal pouches.20,21 Earlier studies often attributed the anti­cancer effect of algae to its content in carotenoids since beta-carotene has been shown to have an effect similar to that of algae extract. A more recent study, however, showed that the sulfated polysaccharide mentioned above, Ca-SP, appears to inhibit tumor invasion and metastasis.22 Both the in vitro and in vivo effects of Ca-SP suggest that the intra­venous administration of Ca-SP reduces the lung metastasis of melanoma cells by inhibiting the tumor invasion of the basement membrane. A water-based extract of Aphanizomenon flos aquae containing high concentrations of phycocyanin inhibited the in vitro growth of one out of four tumor cell lines tested, indicating that at least some tumor cell types may be directly sensitive to killing by phycocyanin (Jensen et al, manuscript in preparation). Another fresh-water blue-green algae, Phormidium tenue, contains several diacyl­glycerol compounds which effectively inhibited chemical-ly-induced skin tumors in mice.23 In addition, Spirulina was shown to have a modulatory effect on hepatic carcinogen metabolizing enzymes.24

Of major interest to ongoing research in inflammation as well as breast cancer is the finding that C-phycocyanin selectively inhibits COX-2, but has no effect on COX-1.25 The COX enzymes are involved in prostaglandin synthesis. Since COX-2 is over-expressed in many breast cancer cells, and inhibition of COX-2 leads to a markedly reduced tumor growth and blocks angiogenesis, the finding that phyco­cyanin specifically interferes with this pathway holds promise.

BLUE-GREEN ALGAE AS A BIOMODULATOR
Besides their effects on the immune system, blue-green algae have also been reported to modulate other systems and improve metabolism. In the past few years increasing attention has been given to the study of the therapeutic effects of blue-green algae. The anecdotal claims for such effects are numer­ous. Although there is limited data from controlled animal or clinical studies, such claims include improvement in condition of Alzheimer’s patients, overall enhancement of immune response, improvement in fibromyalgia, control of hyperten­sion, alleviation of depression and chronic fatigue, increased stamina, healing of internal and external lesions, increased mental acuity, and general improvement in overall well-being. This last section will review the scientific evidence supporting the therapeutic effects of blue-green algae.

EFFECTS ON METABOLISM
Several reports from different labs have shown that cer­tain species of blue-green algae have cholesterol-lowering effects in animal and human models.  In feeding experiments in rats, two studies have reported that the elevation in total cholesterol, LDL, and VLDL cholesterol in serum caused by cholesterol feeding was reduced when the high cholesterol diet was supplemented with 16% and 5% blue-green algae, respectively.31,32 In addition, Kato found that adipohepatosis induced by a high fat and high cholesterol diet was cured rapidly when the diet was supplemented with algae.31 Investigations into the mechanism of this phenomenon led to the finding that the algae-fed group showed a statistically sig­nificant increase in the activity of lipoprotein lipase, a key enzyme in the metabolism of triglyceride-rich lipoproteins.33

The hypocholesterolemic effect of blue green algae was also observed in humans in a study conducted on 30 patients with mild hyperlipidemia and mild hypertension.34 Patients took 4.2 grams of algae or placebo per day, and were observed for two months. At the end of the study, patients taking the algae showed a significant reduction of LDL-cho-lesterol (p<0.05) compared to the control group. LDL cho­lesterol increased back to baseline levels after administration of the algae was discontinued. In addition to lowering LDL cholesterol levels, the atherogenic index (a measure of fat deposition in arteries) declined significantly after four weeks of algae consumption.

In a recent study by Kushak et al, rats were fed the blue-green alga Aphanizomenon flos-aquae and total cholesterol level was monitored. After 43 days, cholesterol levels were significantly decreased when compared to the control group.30 Although Aphanizomenon flos-aquae contains a significant amount of the omega-3 polyunsaturated linolenic

Table 4. Biomodulatory Effects of Whole Blue-Green Algae on Metabolism

Algae Species Introduced as

Test Species

Effects Reference Effects
Aphanizomenon Food Rat Reduction of cholesterol Kushak et al, 2000 Reduction of cholesterol
Food Rat Reduction of blood glucose levels Drapeau et al, 2001 Reduction of blood glucose levels
Food Human Modulation of brain activity (EEG) Walker & Valencia, 1999 Modulation of brain activity (EEG)
Spirulina Food Human Reduced body weight Becker et al, 1986 Reduced body weight
Food Rat Reduction of cholesterol Kato et al, 1984 Reduction of cholesterol
Food Rat Increased activity of lipase Iwata et al, 1990 Increased activity of lipase
Food Rat Reduced glucose levels Takai et al, 1991 Reduced glucose levels
Food Rat Inhibition of maltase and sucrase Kushak et al, 1999 Inhibition of maltase and sucrase
Food Mouse Modulation of carcinogen metabolic enzymes Mittal et al, 1999 Modulation of carcinogen metabolic enzymes
Food Mouse Modulation of lead toxicity Shastri et al, 1999 Modulation of lead toxicity
Food Rat

Increased iron status during pregnancy and lactation

Kapoor & Mehta, 1998

Increased iron status during pregnancy and lactation

Nostoc Food Rat Reduction of cholesterol Hori et al, 1994 Reduction of cholesterol

acid, the effect on cholesterol levels seemed unrelated to the lipid content of the diets. Kushak et al30 proposed that the hypocholesterolemic effect of Aphanizomenon flos-aquae may be due to its chlorophyll content which was shown to stimulate liver function and decrease blood cholesterol.35

In a double-blind crossover study involving human patients, supplementing the diets of obese outpatients with 2.8 grams of bluegreen algae three times daily over a four week period resulted in a statistically significant reduction of body weight.36 In a study measuring the effect of bluegreen algae on glucose levels in diabetic rats, the water-soluble fraction was found to be effective in lowering the serum glucose level at fasting, while the water insoluble fraction suppressed glu­cose levels at glucose loading.37 In another study investigating the effect of the blue-green alga Aphanizomenon flos-aquae on rat intestinal mucosal digestive enzymes, it was observed that this alga specifically inhibited the activity of maltase and sucrase in a dose-dependent manner.38 Furthermore, this decrease in enzymatic activity was accompanied by a dose-dependent decrease in blood glucose.

The overall conclusion is that blue-green algae may have benefits on lipid and sugar metabolism, as well as liver function. Further human studies are needed to address the feasibility of using blue-green algae in conjunction with cholesterol-lowering medication.

OTHER EFFECTS OF BLUE GREEN ALGAE
Other research studies on blue green algae consumption deserve mention. Many reports exist in the literature on its antimicrobial effects.  The secretion of anti-microbial sub­stances is an important part of the competition for ecological niches in the natural environment. However, an interesting caveat exists. In one study, Spirulina was cultured in vitro, and the extracellular medium was shown to stimulate the growth of lactic acid bacteria.39 If the growth-promoting sub-stance(s) exist in sufficient amounts intracellularly, blue green algae may play a role in vivo by supporting friendly gut bacteria. This leads to other facets of health including gut health and nutrient absorption. On that note, consumption of Spirulina was shown to support the iron status and hemoglo­bin of rats during pregnancy and lactation.40 Spirulina fusiformis had a significant protective effect against lead-induced toxicity in rats.41 Finally, a report by Valencia et al has presented evidence that Aphanizomenon flos-aquae accelerates recovery from mild traumatic brain injury.42

CONCLUSION AND SUMMARY
Research results based on the numerous isolated com­pounds from blue green algae warrant the exploration of using whole algae as conjunctive therapy due to the possible synergistic effects of many phytochemicals within the whole algae. The emergence of composite algae supple­ments in contrast to single algae supplements may also yield further anti-inflammatory, immune-boosting, and metabolic benefits. A significant body of data suggests that blue green algae immunoenhancing properties could be useful in the adjunct treatment of various diseases involving 1) sup­pressed or exhausted immune system, and 2) inappropriate immune response including allergies, autoimmune diseases, and chronic inflammatory conditions. The data presented also suggests that blue green algae could be useful as an adjunct in the treatment of cancer and AIDS, and calls for the design of controlled human clinical studies.

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Winter 2001 Vol. 3, No. 4  JANA  28

HAK PATEN: KEGUNAAN NIGELLA SATIVA (HABBATUS SAUDA) UNTUK MENINGKATKAN FUNGSI IMUN (KEKEBALAN TUBUH)

HAK PATEN:
KEGUNAAN NIGELLA SATIVA (HABBATUS  SAUDA) UNTUK MENINGKATKAN FUNGSI IMUN (KEKEBALAN TUBUH)
Use of Nigella sativa to increase immune function

Document Type and Number:
United States Patent 5482711

Abstract:
A pharmaceutical composition containing an extract of the plant Nigella sativa is disclosed for treating cancer, preventing the side effects of anticancer chemotherapy, and for increasing the immune function in humans.

Inventors:
Medenica, Rajko D. (One Ocean Point, Port Royal Plantation, Hilton Head Island, SC, 29928)
Application Number:
08/111631
Filing Date:
08/25/1993
Publication Date:
01/09/1996
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Referenced by:
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Primary Class:
424/776
Other Classes:
514/885, 424/725
International Classes:
A61K39/39; A61P35/00; A61K35/78
Field of Search:
424/195.1, 514/885
US Patent References:
4687761    August, 1987    Liu    514/26    Pharmaceutical composition for increasing immunity and decreasing side effects of anticancer chemotherapy
4945115    July, 1990    Liu    514/731    Process for preparing ferulic acid
Other References:
Elkadi et al. 71st Annual Meeting of the Federation of American Societies for Experimental Biology Washington D.C. Mar. 29-Apr. 2, 1987, 46(4), 1222.
Elkadi et al. Arch AIDS Res 1 (2-3), pp. 232-233, 1987.
Dey, K. L., and Bahadur, R., 1984, Indigenous Drugs of India, International Book Distributors, Dehradun, India.
Kirtikar, K. R., and Basu, B. D., 1987, Indian Medicinal Plants, vol. I, International Book Distributors, Dehradun, India.
Nadkarni, K. M., 1976, “Crocus sativus, Nigella sativa,” Indian Materia Medica, vol. I, K. M. Nadkarni (ed), Bombay Popular Prakashan, Bombay, India.
Agarwal, R.; Kharya, M.D. and Shrivastava, R., 1979, “Antimicrobial Anthelmintic Activites of the Essential Oil of Nigella Sativa Linn.,” Indian J. Exp. Biol. 17:1264-5.
Akhtar, M. S. and Riffat, S., 1991, “Field Trial of Saussurea Lappa Roots Against Nematoides and Nigella Sativa Seeds Against Cestodes in Children,” J.P.M.A. 41(8):185-7.
al-Awadi, F. M.; Khatter, M. A. and Gumaa, K. A., 1985, “On the Mechanism of the Hypoglycaemic Effect of a Plant Extract,” Diabetologia 28:432-4.
al-Awadi, F.; Fatania, H. and Shamte, U., 1991, “The Effect of a Plant’s Mixture Extract on Liver Gluconeogenesis in Streptozotocin Induced Diabetic Rats,” Diabetes Res. (Scotland) 18(4):163-8.
Aruna, K. and Sivaramakrishnan, V. M., 1990, “Plant Products as Protective Agents Against Cancer,” Indian J. Exp. Biol. 28(11):1008-11.
Aruna, K. and Sivaramakrishnan, V. M., 1992, “Anticarcinogenic Effects of Some Indian Plant Products,” Fd. Chem. Toxic. (England) 30(11) :953-6.
Bitterman, W. A.; Farhadian, H.; Abu Samra, C.; Lerner, D.; Amoun, H.; Krapf, D. and Makov, U. E., 1991, “Environmental and Nutritional Factors Significantly Associated with Cancer of the Urinary Tract among Different Ethnic Groups,” Urol. Clin. North Am. 18(3):501-8.
Datta, A. K.; Biswas, A. K. and Ghosh, P. D., 1983, “Chromosomal Variations in Callus Tissues of Two Species of Nigella,” The Nucleus 26(3):173-7.
Elkadi, A. and Kandil, O., 1987, “The Black Seed Nigella Sativa and Immunity: Its Effects on Human Cell Subsets,” Fed.Proc. 45(4):1222.
Finter, N. B., 1969, “Dye Uptake Methods for Assessing Viral Cytopathogenicity and Their Application to Interferon Assays,” J. Gen. Virol. 5:419-427.
Kumar, B. H. and Thakur, S. S., 1989, “Effect of Certain Non-Edible Seed Oils on Growth Regulation in Dysdercus Similis (F),” J. Anim. Morphol. Physiol. 36(2) pp. 209-218.
Medenica, R.; Alonso, K.; Huschart, T. and Tyler, K., 1990, “Tumor Tissue Culture for Determining Efficient Drug for Intra-Arterial, Intra-Hepatic Chemotherapy of Colon Carcinoma Liver Metastasis,” Abstract presented at Conference on Combining BRM with Cytotoxic in the Treatment of Cancer.
Merkel, D. E., Dressler, L. G. and McGuire, W. L., 1987, “Flow Cytometry Cellular DNA Contents and Prognosis in Human Malignancy,” J. Clin. Oncol., 5:1690-1703.
Metcalf, D., 1984, Clonal Culture of Hematopoietic Cells, Elsevier/North American Biomedical Press.
Metcalf, D., 1985, “The Granulocyte-Macrophage Colony-Stimulating Factors,” Science 229:16-22.
Nair, S. C.; Salomi, M. J.; Panikkar, B. and Pannikar, K. R., 1991, “Modulatory Effects of Crocus Sativus and Nigella Sativa Extracts on Cisplatin-Induced Toxicity in Mice,” J. Ethnopharmocol 31(1): 75-83.
Salmon, S. E.; Hamburger, A. W.; Soehnlein, B.; Durie, B. G.; Alberts, D. S. and Moon, T. E., 1978, “Quantitation of Differential Sensitivity of Human-Tumor Stem Cells to Anticancer Drugs,” N. Eng. J. Med. 298:1321-7.
Salomi, N. J.; Nair, S. C.; Jayawardhanan, K. K.; Varghese, C. D. and Panikkar, K. R., 1992, “Anititumour Principles from Nigella Sativa Seeds,” Cancer Lett. 63(1):41-6.
Salomi, M. J.; Nair, S. C. and Panikkar, K. R., 1991, “Inhibitory Effects of Nigella Sativa and Saffron (Crocus Sativus) on Chemical Carcinogenesis in Mice,” Nutr. Cancer 16(1): 67-72.
Sayed, M. D., “Traditional Medicine in Health Care,” 1980, J. Ethnopharmocol. 2(1): 19-22.
Shayeb, N. A. and Mabrouk, S. S., 1984, “Utilization of Some Edible and Medicinal Plants to Inhibit Aflatoxin Formation,” Nutrition Reports International 29(2): 273-289.
Siddiqui, M. B.; Alam, M. M.; Husain, W. and Sharma, G. K., 1988, “Ethno-medical Study of Plants Used for Terminating Pregnancy,” Fitoterapia LIX(3): 250-2.
Srivastava, K. C., 1989, “Extracts from Two Frequently Consumed Spices-Cumin (Cuminum cyminum) and Turmeric (Curcuma Longa)-Inhibit Platelet Aggregation and Alter Eicosanoid Biosynthesis in Human Blood Platelets,” Prostaglandins Leukot Essent Fatty Acids 37(1): 57-64.
Tennekoon, K. H.; Jeevathayaparan, S.; Kurukulasooriya, A. P. and Karunanayake, E. H., 1991, “Possible Hepatotoxicity of Nigella sativa Seeds and Dregea Volubilis Leaves,” J. Ethnopharmocol. 31(3): 283-9.
Vihan, V. S. and Panwar, H. S., 1987, “Galactopoietic Effect of Nigella Sativa (H-Kalonji) in Clinical Cases of Agalactia in Goats.” Indian Vet. J. 64:347-9.
Von Hoff, D. D.; Cowan, J.; Harris, G. and Reisdorf, G., 1981, “Human Tumor Cloning: Feasibility and Clinical Correlations,” Cancer Chemother. Pharmacol. 6:265-271.
Primary Examiner:
Robinson, Douglas W.
Assistant Examiner:
Lee, Howard C.
Attorney, Agent or Firm:
DeWitt Ross & Stevens
Claims:
I claim:

1. A method for activating immune competent cells in humans in order to increase the immune function in humans, the immune competent cells being selected from the group consisting of CD19, HLADR, NKCD3-/CD56+ and CD38, the method comprising administering to humans an effective dose of an extract from Nigella sativa at a concentration which is effective to activate the immune competent cells by reducing the presence of interferon inhibitor factor or lymphokine inhibitor factor.

2. The method of claim 1 wherein the effective dose is between about 20 and about 40 grams of the extract per day.

3. The method of claim 1 wherein the effective dose is about 30 grams of the extract per day.

4. A method for increasing antibody producing B cells in humans, the B cells having minor antigen binding sites, comprising administering to humans an effective dose of an extract from Nigella sativa, at a concentration which is effective to free the tumor antigen binding sites on the B cells thereby increasing the antibody producing B cells.

5. The method of claim 4 wherein the effective dose is between about 20 and about 40 grams of extract per day.

6. The method of claim 4 wherein the effective dose is about 30 grams of extract per day.

Description:

FIELD OF THE INVENTION

The present invention is generally directed to the fields of medicine and pharmacology, and specifically directed to using the plant seed extract of Nigella sativa Linn (N. sativa) in the treatment of cancer, viral diseases, protection from side effects of chemotherapy and growth factor for bone marrow in hematopoiesis.

CITED REFERENCES

A full bibliographic citation of the references cited in this application can be found in the section preceding the claims.

DESCRIPTION OF THE PRIOR ART

A variety of herbal and plant extracts or preparations are available today for treating any number of diseases affecting the human body. Some preparations have been known for literally thousands of years while others are just being discovered to have curative effects. Effective plant extracts are highly desired as a “natural” way to treat a disease. It is believed that natural preparations will not have as much of an adverse effect on the body as synthetic preparations.

One of the primary targets for treatment is cancer. Anticancer remedies are available today which are effective in killing cancer cells. However, many of these medicaments also damage or kill off normal cells or have other serious side effects. It is therefore vitally important to develop an anticancer program which is specific for the cancerous growth in a body, but which is not toxic to the rest of the body system. Ideally, the program will include treatment using natural plant extracts. As used in this disclosure, the term “body” or “patient” can include any warm-blooded mammal, but is specifically intended to refer to the human body.

The medicinal properties of various spices and herbs in general is known (Srivastava, 1989). U.S. Pat. No. 4,986,895 to Grossman et al. is directed to use of water-soluble plant extracts in the treatment of virus skin infections. U.S. Pat. No. 5,178,865 to Ho et al. is directed to the use of Chinese herbal extracts in the treatment of HIV related disease in vitro. A total of 56 herbal extracts were screened for anti-HIV activity using in vitro techniques.

Aruna (1990) also describes the use of spices, leafy vegetables and condiments having diverse medicinal properties. Products of 20 spices or leafy vegetables were screened for anti-carcinogenic activity using induction of glutathione-S-transferase. One of the plants utilized was Cuminum cyminum Linn (C. cyminum), also known as cumin. All of the spices and leafy vegetables were tolerated well and no toxic effects were seen.

Bitterman et al. (1991) disclose a study that was performed on a population of 964 adult patients, of which 28% suffered from malignant diseases of the urinary tract and 72% from a wide spectrum of the nine neurologic diseases. The results conclude that the use of C. cyminum in the diet may contribute to the prevention of diseases mediated by peroxidation of lipids.

Aruna and Sivaramakrishnan (1992) reported on anticarcinogenic properties of some spices. Cumin seeds (C. cyminum Linn) were studied. Cumin seed significantly inhibited some carcinogenesis.

Another plant extract from the plant N. sativa has shown a wide range of medical use. N. sativa is an annual herb belonging to family Ranunculaceae. Other species of Nigella include Nigela arvensis and Nigella damascena. Induction of callus cultures indicates considerable chromosomal variations in callus tissues between the different species of Nigella (Datta, et al. 1983).

N. sativa is characterized by an erect branched stem and alternate finely divided, feathery, grayish-green leaves. The bluish-white, star-shaped flowers are terminal and solitary. Petals are absent. The fruit is a globose capsule with small, black, rough seeds. The plant is cultivated in India, Bangladesh, Turkey, Middle-east and the Mediterranean basin mainly for its seeds or “black cumin” which is almost entirely used for edible and medical purposes, such as spices and for treatment of various diseases.

The ripe seeds of N. sativa, also known as Kalajira or Kalaonji, are known to have a wide range of medicinal uses (Kirtikar et al. 1982, and Chopra et al. 1982). The constituents of the seeds include saponin, an essential oil, a bitter compound (nigellone) and tanners. These substances have been shown to have diuretic (Nadkarni 1976), cholagogic and antispasmodic (Tennekoon, et al. 1991), carminative (Shayeb and Mabrouk, 1984), galactogogic (Vihan 1987), antibacterial (Hassan, et al. 1989), antifungal (Agarwal, et al 1979), anthelminthic (Akhtar 1991) and emmenagogic (Siddiqui et al. 1988) properties. al-Awadi, et al. (1985) have demonstrated an antidiabetic effect of N. sativa plant extract.

N. sativa has been reported to be used in Egyptian folk medicine as a diuretic and carminative (Sayed 1980). The oil is used in the treatment of asthma, respiratory oppression and coughs. The active principle, nigellone, has been isolated from the volatile oil fraction and is reported to be useful in the treatment of bronchial asthma.

The petroleum ether extract of the seeds at 1000-62.5 parts per million (ppm) concentrations was found to have the same activities as growth regulating juvenile hormone when tested against the fifth instar larvae of Dysdercus similis (Kumar et al. 1987).

al-Awadi et al. (1981) is directed to the study of the effect of a plant’s mixture extract containing N. sativa on liver gluconeogenesis. The researchers report that non-insulin dependent diabetes mellitus is treated in Kuwait by a plant mixture extract, which contains N. sativa. In this study, a powdered mixture of equal portions of N. sativa, Linn, Commiphora myrrh, Eng, Ferula Asafoetida, Linn, Aloe vera, Linn, and olibanum was boiled in distilled water for 10 minutes. Diabetic animals were given a daily dose by gastric intubation. The results indicate that the anti-diabetic action of the plant’s extract is at least partly mediated through decreased liver gluconeogenesis.

Elkadi and Kandil (1987) are directed to N. sativa and its effect on human T-cells. N. sativa was tested in volunteers with a low helper T-cell to suppressor T-cell ratio. The results indicated an increase in the helper T-cell population in the experimental group. Further, the helper T-cell to suppressor T-cell ratio increased while the ratio within the control groups remain the same.

Nair et al. (1991) investigated the effects of N. sativa as potential protective agents against cisplatin-induced toxicity in mice. Some protective effects were shown by the use of N. sativa extracts.

Salomi, N. J., et al. (1992) studied N. sativa seeds containing certain fatty acids for antitumor activities against Ehrlich ascites carcinoma (EAC), Dalton’s lymphonia ascites (DLA) and Sarcoma-180 (S-180) cells. The paper presents the results of in vitro and in-vivo antitumor experiments. The active antitumor principle was isolated. It was found that the active principle was cytotoxic for EAC cells, KB cells and lymphocytes.

Salomi et al. (1991) reported the effect of the active principle isolated from N. sativa in inhibiting chemically induced skin carcinogenesis. Intraperitoneal administration of N. sativa extract was shown to prevent the incidents of soft tissues sarcomas and reduced tumor diameters in treated groups.

Metcalf (1984, 1985) reported the inhibitory effects of N. sativa on chemical carcinogenesis in mice. However, there was no evidence in these papers of the destruction of human tumor cells.

SUMMARY OF THE INVENTION

The present invention provides an anticancer remedy and treatment which has, as its active ingredient, the extract of the plant N. sativa. When used properly, the medicament of the present invention is useful in treating cancer, preventing toxicity of anticancer drugs in human body and in increasing immune function.

The present invention is specifically directed to a pharmaceutical composition for the treatment of cancer comprising a pharmaceutical preparation consisting essentially of an extract from Nigella sativa, at a concentration which is effective to destroy cancer cells in a patient.

Additionally, the present invention is directed to a pharmaceutical composition for the treatment of the side effects of anticancer therapy consisting essentially of an extract from Nigella sativa, at a concentration of the extract which is effective to reduce the side effects of anticancer therapy.

The present invention is also directed to a method for treating humans suffering from the side effects of anticancer chemotherapy using the extract of Nigella sativa, comprising administering to humans effective doses of the composition described above.

Further, the present invention is directed to a method for increasing the immune function in humans comprising administering to humans effective doses of an extract from Nigella sativa, at a concentration of the extract which is effective to increase the immune function.

The present invention is also directed to a method for protecting the normal cells from cytopathic effects of virus, comprising administering to humans effective doses of an extract from Nigella sativa, at a concentration of the extract which is effective to protect against the cytopathic effects of the virus.

The present invention is still further directed to a method for increasing antibody producing B cells, comprising administering to humans an extract from Nigella sativa, at a concentration which is effective to increase the antibody-producing B cells.

The present invention is also directed to a process for inhibiting tumor cells without affecting normal or nontumor cells in a patient comprising administering to a patient an extract from Nigella sativa, at a concentration which is effective to inhibit the tumor cells without affecting nontumor cells.

The present invention is also directed to a method for stimulating bone marrow formation in humans comprising administering to humans effective doses of an extract from Nigella sativa, at a concentration of the extract which is effective to stimulate bone marrow formation.

In general, N. sativa extract helps stimulate bone marrow cells, protects the normal cells from cytopathic effects of virus, destroys tumor cells and increases antibody producing B cells. It protects the bone marrow against chemotherapy and at the same time, can act as an anticancer agent. All these factors makes N. sativa seed extract an ideal candidate to be used as vaccine for cancer prevention and cure.

N. sativa plant extract is more effective than standard chemotherapeutic anti-cancer drugs. N. sativa extract stimulates bone marrow cells, protects the normal cells from cytopathic effects of virus, destroys tumor cells and increases antibody producing B cells. Further, it protects the bone marrow against chemotherapy and can act as an anti-cancer agent.

N. sativa plant extract also has been found to help restore immune competent cells in immunosuppressed cancer patients and to overstimulate bone marrow formation in normal individuals.

N. sativa extract helps free tumor antigen binding sites on B cells. The administration of the N. sativa extract, rather than the increase of the immune competent cell number, has been found to help free tumor antigen binding sites on B cells, thereby elevating the CD19 and associated cell population. When the antigen binding site on the immunoglobulin molecule on the surface of B cells is free because of N. sativa treatment, it binds to the tumor associated antigen thereby generating an immune response against the antigen.

Protection of Human Amniotic “WISH” cells from cytopathic effects of vesicular stomatitis virus (VSV) was also observed upon administration of N. sativa plant extract. Additionally, the serum interferon level is found to increase; and, hence, the plant extract of N. sativa has interferon-like antiviral activity. This is an example of interferon level increasing in the circulation, preventing viral diseases and, in addition, possibly curing viral diseases.

N. sativa promotes anti-tumor activity. Data from pharmacosensitivity screening indicates anti-tumor activity of N. sativa plant extract mainly against melanoma and colon cancer types. N. sativa plant extract destroys tumor cells and leaves normal cells alone, possibly because of its ability to bind to cell surface asialofeutin (lectin) in diseased cells, which causes aggregation and clumping of tumor cells. It also blocks enzymes and inappropriate gene products involved in nucleic acid synthesis and metabolism.

Further objects, features and advantages of the invention will be apparent from the following detailed description when taken in conjunction with the accompanying drawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph illustrating the elevation in CD19, HLADR, NK CD3-/CD56+ and CD38 populations of peripheral blood cells from cancer patients upon incubation with N. sativa extract over a 18 hour period at 37° C. in 5% CO 2 incubator as shown in Experiment 2.

FIG. 2 is a graph illustrating the percent protection of 3.5×10 4 WISH cells from the cytopathic effects (CPE) of vesicular stomatitis virus (VSV) by serial dilutions of N. sativa extract as described in Experiment 3.

DETAILED DESCRIPTION OF THE INVENTION

Definitions:

The following definitions will be used for the present application:

B cells: B cells or B lymphocytes secrete proteins/antibodies that protect the human body against infections.

CD3: Cluster Differentiation 3. These are the antibodies which indicate Activated T lymphocytes which are used by the body for its protection against foreign harmful germs.

CD19: Cluster Differentiation 19. These are antibodies which help detect B lymphocytes. Elevation in CD19 indicates an elevation in B lymphocytes and vice versa.

CD56: Cluster Differentiation 56 are antibodies which inhibit Natural Killer target cell interactions in certain systems.

G-CSF: Granulocyte-Colony Stimulating Factor

GM-CSF: Granulocyte Macrophage-Colony Stimulating Factor.

HLADR: Human Leukocyte antigen DR. DR designates a genetic locus or the antigen of the major histocompatibility complex corresponding to the locus. An increase in HLADR indicates an elevation in immunological parameters against the disease.

NK: Natural Killer cells. NK is an indication to detect the Natural Killer cells.

NKCD3-/CD56+: Natural Killer Cluster Differentiation 3-/Cluster Differentiation 56+.

Preparation of N. sativa Extract:

The process for preparing the N. sativa extract comprises grinding the seeds and separating the extract of the N. sativa with appropriate solvents such as alcohol or water, removing lipids by extraction with ether or petroleum ether, crystallization or chromatographic fractionation and then mixing its components in the desired proportion. The N. sativa extract can then be prepared in 3 forms–oil, fluid and crystal–by processes known to the art. The preferred process for the preparation of N. sativa extract is described in Experiment 1.

Administration:

The extract of N. sativa may be administered by itself or in admixture with an appropriate excipient or carrier. The preparation may be administered to the patient by enteral, such as oral or rectal, and parenteral, such as intraperitoneal, intramuscular, intravenous or subcutaneous route. The preparation may also be administered in combination with supplements, such as antiviral agents, immune modulators, antibodies, other chemotherapeutic agents, or combinations thereof. The preparation may additionally be administered in dosage form, such as by capsules, tablets, suppositories or the like.

Dosages:

N. sativa has been found to be most effective when administered at a dosage of 30 g per day, with an effective range of 20-40 g per day.

N. sativa extract is also known to confer protection of human amniotic “WISH” cells against cytopathic effects of vesicular stomatitis virus (VSV). The plant extract at a dilution of 1:1000 when incubated with 3.5×10 4 WISH cells for 18 to 24 hours at 37° centigrade gave maximum protection.

Theoretically, a patient weighing 70 kg has about 7×10 13 cells in its body and N. sativa will be useful at a dosage between about 20 and 40 g per day and preferably about 30 g per day to protect against viral attack in virus endemic areas.

The invention is further illustrated by the following experiments and tests but not limited by the following experiments:

EXPERIMENTS

To evaluate the usefulness of N. sativa for cancer treatment, the activity of the N. sativa extract was measured on bone marrow and peripheral white blood cells. In vitro antiviral antitumor and growth factor like activity were also measured.

N. sativa extract was incubated with bone marrow cells to determine the growth of the cells. The results were compared with that of bone marrow growth factors and biological response modifiers (GM-CSF, G-CSF, erythropoietin, interferon, IL-2, and STS). Mouse connective cells and human amnion or “WISH” cells were also assayed.

The following calculations were used in the examples:

Calculation of Percent Elevation: ##EQU1## in which R T is the average cell count of the experimental well with extract/growth factors, R C is the average background cell count with control, R MAX is the average maximum elevation without extract/growth factor.

Calculation of Percent Inhibition: ##EQU2## in which R T is the average cell count of the experimental well with extract/Abrin control, R C is the average background cell count with control, R MAX is the average maximum inhibition without extract/Abrin control.

Following are descriptions of some procedures used in the experiments. Universal safety precautions, known to the art, must be observed when handling all biological materials.

Procedure 1

Flow Cytometry Direct Immunofluorescence Staining

Automated Flow Cytometry (FC) provides an efficient, sensitive and quantitative method to analyze cell populations, sub-populations, and their components in suspension. Cells express and shed surface antigens throughout their life indicating their classification, stage of maturation, activation state and disease state. Monoclonal antibodies (mABs) have been developed that specifically bind these surface antigens. Established clinical applications are in leukemia and lymphoma diagnosis, T-cell subset analysis, monitoring transplant rejection, monitoring the effects of chemotherapeutic agents on different cell types and measuring cellular activation.

Whole blood, bone marrow or cellular suspension is first treated with a red blood cell lysing solution, washed, and then mixed with a labeled mAB against a specific membrane antigen. The direct staining procedure is then followed by analysis with the FACSCAN Immunocytometry Systems flow cytometer (FACSCAN Users’ Guide, Becton Dickinson).

All specimens are generally labeled with the following information: 1) Patient name; 2) Date drawn; 3) Time drawn; 4) Phlebotomist’s initials; and 5) Panel number. Patient specimens are identified by the nurse or phlebotomist generally by checking the wristband to verify the name of the patient. A unique tracking number is assigned to each individual specimen to assure proper specimen tracking.

Peripheral Blood is aseptically collected in an appropriate container such as a lavender top (EDTA anti-coagulant) vacutainer tube and delivered at room temperature preferably within 48 hours. The minimum amount required is approximately 2 ml whole blood per panel ordered. The optimum amount required is approximately 3 ml whole blood per panel ordered

The bone marrow (BM) specimen is aseptically collected in a container such as a lavender top (EDTA) vacutainer tube and transported at room temperature within 48 hours. The minimum amount required is approximately 2 ml of BM specimen per panel ordered. The optimum amount is approximately 3 ml of BM specimen per panel ordered.

Solid tumors include those from the breast, lymph node, colon, ovarian, lung, and skin. Reference is made to the HTCA Pharmacosensitivity Procedure (Procedure 5, infra.) for a description of the procedures. The tumor should be delivered at room temperature within 48 hours of extraction. The minimum amount required is approximately 2 ml of cells at a concentration of 1×10 6 /ml per panel ordered. The optimum amount is approximately 3 ml of cells at a concentration of 1×10 6 /ml per panel ordered.

Materials:

The materials required are as follows:

EDTA Vacutainer Blood Collection Tubes

12×75 mm plastic test tubes

Serofuge

FACSCAN Flow Cytometer

Micropipettes (20 ul and 100 ul)

Micropipet Tips

Repeater Pipet

Small Beakers

Gauze Squares

Monoclonal Antibodies

Lysing Solution

PBS

0.5% p-Formaldehyde

Transport Media

50 ml Conical Tubes

Repeater Pipet Tips

Safety Shield

Sorvall TR6000 centrifuge

Coulter Cytotrol control cells

Reagents:

The reagents are prepared as follows:

A. Monoclonal antibodies–see package inserts for proper reconstitution and storage of various mABs. For Coulter mABs, reconstitute according to package insert and then make a 1:2 dilution in sterile water and place in an appropriate container.

B. Lysing solution–(Becton-Dickinson order #92-0002). To prepare 1× working solution, add 10 ml 10× lysing stock solution to 90 ml distilled water. Mix well. Store at room temperature. Discard after one week.

C. Phosphate Buffered Saline (PBS) without Ca++ and Mg++ (Gibco order #310-4190AJ)

D. 0.5% Paraformaldehyde. Dissolve 2.5 g paraformaldehyde (Baker S-898-7) in 500 ml of 1× PBS without Ca++ or Mg++.

E. Coulter Cytotrol control cells. Reconstitute Cytotrol control cells according to manufacturers’ package insert. These cells must be prepared fresh daily.

Quality Control:

A leukogate and a negative control tube must be run for each patient. Tubes for Cytotrol control cells should be included for each mAB used that day.

Procedure:

Label test tubes with patient name and appropriate mAB. Using a micropipet, to each tube add 20 ul of the appropriate antibody. Using a micropipet, to each tube add 100 ul of the patient whole blood. Vortex each tube. Incubate the tubes at room temperature for 15 minutes. Using the repeater pipet (set on 4) add 2 ml of 1× lysing solution to each tube. Incubate the tubes at room temperature for 10 minutes. Centrifuge tubes in serofuge set on high for 3 minutes or in Sorvall TR6000 for 5 minutes at 3000 RPM. Pour off supernatant in waste beaker, being careful not to splash. Blot top of tube on gauze square. Vortex each tube to break pellet (use safety shield). Using repeater pipet (set on 4) add 1 ml of 1× PBS to each tube and vortex each tube (use safety shield). Centrifuge tubes in a serofuge set on high for 3 minutes .or in Sorvall TR6000 for 5 minutes at 3000 RPM. Pour off supernatant in waste beaker being careful not to splash. Blot top of tube on gauze square. Vortex tubes to break pellet (use safety shield). Using repeater pipet (set on 2) add 0.5 ml of 0.5% paraformaldehyde. Vortex. Keep tubes covered with parafilm and in the refrigerator until ready for flow cytometric analysis.

Specimen Analysis:

Analyze each tube on the FACSCAN flow cytometer using Simulset software for surface marker evaluation. (Refer to FACSCAN Users’ Guide and Simulset Software Manual.) Use the complete blood count (CBC) information (be sure CBC was drawn same date and time as FC sample) to enter the total white blood count and % lymphocytes.

Procedure 2

Colony Forming Cells

In order to be able to calculate the potency of the bone marrow, the stem cell assay is performed. Information on the status of Colony Forming Units (CFU) before therapy is performed is obtained. This will allow one to precisely define the medication according to the possible toxicities developed. Also, this will allow the prediction of the toxicity of the medication. The character of CFU when stem cells are treated with different medications will help determine predominance of development of cell lines. It has been demonstrated that interferon prolongs myelopoietic differentiation; therefore, the number of CFU will increase. This will demonstrate efficiency of interferon on bone marrow recovery and confirm the protective activity of interferon to the bone marrow.

With different hemopoietic growth factors, CFU development for the different cell lines can be directed.

Specimen Requirements, Collection and Handling:

Specimen Requirements: Bone marrow sufficient to yield a minimum of 4.0 ml and an optimum of 5.0 ml mononuclear cells at a concentration of 1.0×10 6 cells/ml.

Bone Marrow collection procedure: Prepare 4-6 50 ml Falcon tubes containing 20 ml of tissue transport media. Transport the media in the cooler with frozen ice chips to the procedure. A mask, gloves and gown must be worn during the procedure. Inject 2500 units of preservative-free heparin into the media tubes using sterile technique. This must be done no earlier then 15 minutes before obtaining the bone marrow specimen. Mix well. When bone marrow is handed to the technologist in a syringe, carefully inject into the media tubes, rinsing with media twice. Discard syringe in the Sharps container. Cap tube and mix well. Label the specimen with the following: 1) Patient’s full name; 2) Date specimen was received; 3) Time specimen was received; and 4) Initials of technologist who obtained the specimen. Place in cooler with ice chips for transportation.

Materials:

The following materials are necessary:

Ficoll-Hypaque

Capped Test Tubes [Sterile] 15 ml

Falcon Tubes-50 ml

Sterile Laminar Flow Hood with UV Light

Centrifuge

Sterile Disposable Pipettes

1.0 ml

5.0 ml

10.0 ml

25.0 ml

RPMI 1640 [1×]

Iscove’s Modified Dulbecco’s Medium [1×]

Fetal Bovine Serum

Penicillin/Streptomycin

L-Glutamine [100×]

Trace Elements [100×]

2-Mercaptoethanol

Insulin Transferrin-Sodium Selenite Media Supplement (ITS)

Glass Test Tubes 12×75 ml

Trypan Blue Stain (0.4%)

Hemocytometer With Cover Slips

Microscopes (Light, Inverted)

Tissue Culture Flasks-25 CM 2

Somatostatin-50 μg/ml (Sandoz-Sandostatin)

Interferon-3×10 6 U/ml (Roferon A-Hoffman LaRoche)

Interleukin-2 (Boehringer Mannheim GMBH Cat #799068)

GM-CSF (Amgen Cat #13050)

G-CSF (Amgen Cat #10050)

Epogen (Amgen Cat #06050)

PIXY 321 (Immunex)

CO 2 Incubator

Hand Counter

Ice Chips

Media and Reagent Preparation:

After preparation of each media, the final product is labeled with the following: 1) Name of Product; 2) Preparation Date; 3) Expiration Date; 4) Storage Recommendations; and 5) Technologist’s Initials. 10% RPMI 1640 (1×) G,G Fortified:
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 (1X) with L-Glutamine
50.0 ml Fetal Bovine Serum (Qualified, Heat
Inactivated)
5.0 ml L-Glutamine (100X), 200 mM
1.5 ml Penicillin/Streptomycin
2.0 ml Trace Element Mix (100X),
Lyophilized
0.5 ml 2-Mercaptoethanol
5.0 ml ITS Media Supplement, Lophilized,
Gamma-Irradiated
______________________________________

All components are combined under a sterile laminar flow hood, and sterilized by filtration using a 0.22 micron membrane filter with a 60 micron prefilter. The prepared media is labeled and stored at 2°-10° C.

IMDM/RMPI 1640 [1×] (Tissue Transport Media):
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 [1X]
500.0 ml IMDM [1X]
100.0 ml FBS
5.0 ml Penicillin/Streptomycin
10.0 ml L-Glutamine (100X)
5.0 ml Trace Element Mix (100X)
5.0 ml Nonessential Amino Acids
(100X)
0.5 ml MEM Vitamins
0.5 ml 2-Mercaptoethanol
5.0 ml ITS
______________________________________

All components are combined under a sterile laminar flow hood, and sterilized by filtration using a 0.22 micron membrane filter with a 60 micron prefilter. The prepared media is labeled and stored at 2°-10° C.

Interferon:

Use 1 vial of Roferon A Interferon available from Hoffmann-LaRoche Inc. (3,000,000 U). Take 1 ml Interferon and add 39 ml of RPMI(1×) media to yield a concentration of 75,000 U/ml. Make 40 1 ml aliquots of this dilution and freeze. For the Colony Forming Assay use 1 ml of the 75,000 U/ml Interferon for each 25 cm 2 flask containing 4.0 ml of media and 0.5 ml of cells.

Interleukin-2:

Thaw interleukin-2 and take 5 ml of interleukin-2 containing 200 units per ml. Immediately freeze remaining interleukin-2 into 5 ml aliquots. Add 5 ml of RPMI(1×) media to 5 ml of interleukin-2 containing 200 units per ml to obtain a concentration of 100 units/ml. To 10 tubes containing 9 ml of the media, add 1 ml of interleukin-2 at a concentration of 100 units/ml to obtain a concentration of 10 units/ml. These aliquots are stable for 30 days at 4°-8° C. For colony forming assay, use 0.5 ml (or 5 units) for each 25 cm 2 flask containing 4.5 ml of medium and 0.5 ml of cells.

Somatostatin:

Somatostatin is available in single vials containing 50 μg/ml and 100 μg/ml from Sandoz Ltd. Store at 4°-8° C. For the Colony Forming Assay, use 1.0 ml of STS containing 50 μ/ml for each 25 cm 2 flask containing 4.0 ml of media and 0.5 ml of cells. This procedure is written for 50 μg/ml vials. If 100 μg/ml vials are used, use 0.5 ml of Somatostatin and 4.5 ml of media for a 25 cm 2 flask.

GM-CSF:

Dilute 250 ul of GM-CSF containing 50,000 units in 50 ml of media to obtain 1000 units/ml. Prepare aliquots of 5 ml each containing 5,000 units in sterile tubes with caps. Label each aliquot: GM-CSF–5,000 units (1,000 units/ml). Close nine of these aliquots with sterile adhesive and store at 4° C. Aliquot #10, containing 1,000 units/ml (total 5,000 units), will be used as follows: Pipet one ml into each of 5 sterile tubes. Add 19 ml of media to obtain 50 units/ml. (Each tube will contain a total of 1,000 units). Label each of these aliquots: GM-CSF–50 units/ml (total 1,000 units). Close 4 of these aliquots with sterile adhesive and store at 4° C. Aliquot #5 will be marked “IN USE” and stored at 4° C. For colony forming assay, use 50 ul (or 2.5 units) for 25 cm 2 flask containing 5.0 ml of medium and 0.5 ml of cells.

G-CSF:

Dilute 125 ul of G-CSF, containing 60,000 units in 50 ml of media to obtain 1200 units/ml. Prepare aliquots of 5 ml each containing 6,000 units in sterile tubes with caps. Label each aliquot: G-CSF–6,000 units (1,200 units/ml). Add the date. Close 9 of these aliquots with sterile adhesive and store at 4° C. Aliquot #10 containing 5 ml of 1,200 units/ml (total 6,000 units), will be used as follows: Pipet one ml into each of 5 sterile tubes. Add 19 ml of media to obtain 60 units/ml (each tube will contain a total of 1,200 units). Label each of these aliquots: G-CSF–60 units/ml (total 1,200 units). Add the date. Close 4 of these aliquots with sterile adhesive and store at 4° C. Aliquot #5 will be marked “IN USE” and stored at 4° C. For colony forming assay, use 50 μl (or 3 units) for each 25 cm 2 flask containing 5.0 ml of media and 0.5 ml of cells.

Epogen:

To one ml of epogen containing 2,000 units, add 19 ml of media to yield 20 ml of 2,000 units or 100 units/ml. Aliquot 2 ml into each of 10 cryovials. Label as follows: Epogen–100 units/ml and date. Store at 4°-8° C. For colony forming assay, use 50 μl (or 5 units) for each 25 cm 2 flask containing 5.0 ml of medium and 0.5 ml of cells.

PIXY 321-GM-CSF/IL-3:

Using 15 ml sterile capped tubes, dilute 1 ml of Pixy 321 (be sure to quantitatively transfer by rinsing vials) with 9 ml of 10% BSA and mix well. This will yield a neutralizing effect of 1.0×10 6 units/ml. Aliquot 1.0 ml of this solution of 1×10 6 units/ml into each of 9 cryovials. Label each vial with: name, concentration and expiration date. Store at -70° C. To the remaining 1 ml of 1.0×10 6 units/ml, add 9 ml of 10% BSA and mix well. This will yield a neutralizing effect of 1.0×10 5 units/ml. Aliquot 1.0 ml of this solution of 1×10 5 units/ml into each of 9 cryovials. Label each vial with: name, concentration and expiration date. Store at -70° C. To the remaining 1 ml of 1.0×10 5 units/ml, add 9 ml of 10% BSA and mix well. This will yield a neutralizing effect of 1.0×10 4 units/ml. Aliquot 1.0 ml of this solution of 1×10 4 units/ml into each of 9 cryovials. Label each with: name, concentration, and expiration date. Store at 70° C. To the remaining 1 ml of 1.0×10 4 units/ml, add 9 ml of 10% BSA and mfx well. This will yield a neutralizing effect of 1.0×10 3 units/ml. Aliquot 1.0 ml of this solution into each of 10 cryovials. Label each with: name, “Working Pixy,” concentration, and expiration date. Store at -70° C. One vial may be thawed and stored at 4° C. for use in the assay. Take 1 ml aliquot of 1.0×10 3 units/ml out of the -70° C. freezer and thaw. This will be marked “in use” and stored at 4° C. For Colony Forming Assay, use 50 μL (or 2.5 units) for 25 cm 2 flask.

PROCEDURE

Sample Processing:

Using a sterile pipet, dispense 20-25 ml of histopaque into the appropriate number of capped sterile 50 ml conical tubes. Using another sterile pipet, gently layer the bone marrow at a 45° C. angle onto the histopaque using a 1:1 ratio of histopaque to specimen. Centrifuge at 1600 RPM for 20 minutes in refrigerated centrifuge at 4° C. (brake on 2). Remove and discard the supernatant. Remove the cell interface and place in RPMI(1×) in a pre-labeled tube. Wash cells twice with RPMI(1×) media and centrifuge at 1600 RPM for 5 minutes with a brake of 2. Remove and discard the supernatant. Resuspend the cell pellet in 5 ml of RPMI(1×) medium.

Perform cell count:

In a 12×75 ml glass tube, combine:

0.1 ml of well-mixed cell suspension

0.2 ml of 0.4% Trypan Blue stain

0.7 ml of media

This is a 1:10 dilution.

Mix well and charge one chamber of the hemocytometer with the cell suspension. Under the light microscope, count the viable cells (those which have not absorbed the Trypan Blue) in the four corner 1 mm 2 squares. Count the total number of cells (stained and unstained) in the four corner 1 mm 2 squares.

Calculation for Cell Concentration:

1. Perform the viable cell count using the following equation: Average number of viable cells per square×dilution factor×hemacytometer factor =cells/ml

Sample calculation: 20 Cells (average # of viable cells per square)×10 4 ×10 (dilution factor)=2×10 6 cells/ml.

2. Determine the % viability using the following formula: Viable cell count×100=% viability total cell count

3. Adjust volume to amount needed for the appropriate cell concentration for the assay (this assay requires 1×10 6 cells/ml) using the following formula: (V 1 C 1 =V 2 C 2 )

For example:

V 1 =10 ml V 2 =?

C 1 =2×10 6 cells/mlC 2 =1×10 6 cells/ml ##EQU3## 10 ml×2×10 6 cells/ml=V 2 1×10 6 cells/ml

20 ml=V 2

20 ml-10 ml=10 ml

Ten ml of media must be added to have a volume of 1×10 6 cells/ml.

4. Prepare the flasks: label eight 25 cm 2 liquid tissue culture flasks with the following information: 1) Patient name; 2) Tracking number; 3) Date; 4) Growth Factor or BRM.

5. To each of the 25 cm 2 flasks, add bone marrow cells (BMC), growth factor or biological response modifier (BRM), and media according to Table 1:
TABLE 1
______________________________________
Growth Factor BMC BRM Media
______________________________________

BMC + M 0.5 ml — 5.0 ml
(Control)
BMC + IFN + M 0.5 ml 1.0 ml 4.0 ml
BMC + IL2 + M 0.5 ml 0.5 ml 4.5 ml
BMC + STS + M 0.5 ml 1.0 ml 4.0 ml
BMC + GM-CSF + M
0.5 ml 50 μl
5.0 ml
BMC + G-CSF + M 0.5 ml 50 μl
5.0 ml
BMC + EPO + M 0.5 ml 50 μl
5.0 ml
BMC + PIXY + M 0.5 ml 50 μl
5.0 ml
______________________________________

NOTE: The final volume in all flasks will be 5.5 ml.

NOTE: The final volume in all flasks will be 5.5 ml.

6. Incubate the flasks in the 37° C. and 5% CO 2 incubator. The flasks are to be read and fed as needed, taking care to treat each flask in the assay the same.

Reading and Reporting Results:

At days 7, 14 and 21, scan each of the flasks of the colony forming assay for colonies under the inverted microscope. A colony is defined as 40 or more cells adhering to the bottom of the flask. Floating colonies are not to be counted. Scan the entire flask and report the total number of colonies counted for each flask on the colony forming assay report form.

If no growth is seen at the end of 21 days, report as “No Growth” and hold the flasks for an additional 7 days. Flasks may be discarded after the final report is reviewed by the Medical Director.

Procedure 3

Immunomodulatory Testing

The prediction of clinical or in vitro response to cancer therapy and the corresponding determination of optimum patient treatment through the use of in vitro assays has been the goal of many investigators. The immunomodulatory assay is a procedure to determine how the patient will react to certain biological response modifiers in vitro. It is a necessary addition to other forms of testing in that it can determine if a patient’s serum naturally contains the factors which are able to suppress or activate the growth of tumor cells.

In this procedure, the patient’s serum, and/or WBC’s, is combined with various biological response modifiers (BRM) and co-cultured with a tumor cell line. The percentage of stimulation or percentage of inhibition of the tumor cell growth is determined. This information enables the oncologist to determine appropriate and customized treatment for each patient.

SPECIMEN REQUIREMENTS AND COLLECTION

Label all specimens with patient name, date drawn, time drawn, and phlebotomist’s initial. A unique tracking number will be assigned to each individual specimen to assure proper specimen tracking.

Requirements:

1. Whole blood (WB)–10 ml

2. Serum–3 ml

3. Bone Marrow (BM)–one BM aspiration in 25 ml of transport media. The optimum amount is 3 ml at 1×10 6 cells per ml.

4. Plasmapheresis specimen–3 ml

Both a whole blood specimen and a serum specimen are required for complete immunomodulatory evaluation. However, in the event that only one of the two specimens (WB or serum) is available, partial immunomodulatory testing may be performed.

Collection, Processing, and Handling:

The patient will be properly identified by the nurse or phlebotomist (i.e., check wristband, verify patient name).

Specimens will be aseptically collected by the nurse or a phlebotomist. Gloves and lab coat must be worn while drawing or handling the specimen and “universal precautions” must be observed.

1. Whole Blood

a. Collection–Add 2500 units of preservative free heparin (Calciparine) to a 10 ml red top vacutainer tube. Perform venipuncture and draw the patient’s blood into tube. Label all tubes with patient’s name, date and time collected. Invert several times to mix anticoagulant. Refrigerate tube until ready for separation of the mononuclear layer by the density gradient procedure (Reference is made to Procedure 4, infra., at part B-2).

Minimum amount whole blood=7 ml

Optimum amount whole blood=10 ml

b. Unacceptable Specimens–Clotted specimens, grossly hemolyzed specimens, or frozen specimens are unacceptable.

c. Rejection of Specimens–When any criteria are not met, the unacceptable specimens may be tested if necessary.

2. Serum

a. Collection–Use a red top vacutainer tube to perform venipuncture and draw 10 ml of the patient’s blood into the tube. Centrifuge the serum specimen at 2000 RPM for 10 minutes at 25° C. Refrigerate tube until testing. Aseptically draw off serum and place in a separate tube.

Minimum amount serum=3 ml

Optimum amount serum=5 ml

b. Unacceptable Specimens–Specimens with excessive fibrin clotting are unacceptable.

c. Rejection of Specimens–When any criteria are not met, the unacceptable specimens may be tested if necessary.

3. Plasmapheresis

a. Collection–Add 2500 units of preservative free heparin (Calciparine) to a 10 ml red top vacutainer tube. Draw from the plasma collection container at the beginning of the plasmapheresis procedure. Label tube #1. Refrigerate until testing. Minimum amount of plasma=3 ml

Optimum amount of plasma=5 ml

b. Unacceptable Specimens–Specimens with excessive fibrin clotting are unacceptable.

c. Rejection of Specimens–When any criteria are not met, the unacceptable specimens may be tested if necessary.

4. Bone Marrow

a. Collection–Not more than 15 minutes prior to the BM procedure, add 2500 units of Calciparine per 25 ml of tissue transport media using aseptic techniques. Using aseptic techniques, quickly add the BM specimens to the transport tube and mix well. Refrigerate the tube until ready for separation of the mononuclear layer by the density gradient procedure (see part IV, section B-2).

b. Unacceptable Specimens–Grossly clotted specimens, grossly hemolyzed specimens, or frozen specimens are unacceptable.

c. Rejection of Specimens–When any criteria are not met, the unacceptable specimens may be tested if necessary.

MATERIALS:

The following materials are required for this procedure:

Laminar Flow Hood

Bacto-Agar

Balance

Weighing Paper

Weighing Tools

Capped Bottles (Sterile) (-250 ml, -500 ml)

Distilled Water (Sterile)

Microwave Oven

Autoclave

RPMI 1640 Media

Gentamicin

Disposable Pipettes (Sterile) (-1 ml, -2 ml, -5 ml, -10 ml, -25 ml)

Glutamine

Trace Elements

2-Mercaptoethanol with Dulbecco’s PBS

ITS Solution

Fetal Bovine Serum

Test Tubes (Capped) (-5 ml, -10 ml)

Petri Dishes (Sterile) (Regular 100×15 mm,

Gridded 35 mm)

Falcon Tubes

Conical Tube (Sterile-Plastic)

Trypan Blue Stain (0.4.about.)

Hemocytometer with Cover Slips

Microscopes (Tissue Culture Inverted Microscope, Light Microscope)

pH Paper (Narrow Spectrum)

Graduated Cylinders (50 ml, 100 ml)

Histopaque-1077

Water Bath

Suction Pipetter

Refrigerated Centrifuge

CO 2 Incubator

Biological Response Modifiers (Recombinant Interferon Alpha 2a, Recombinant Interleukin-2, mAB to Interferon Alpha)

Vortex Mixer

Refrigerator (2-8 C.)

Hand Counter

Sharps Container

Pasteur Pipettes

Dropper Bulbs

-70° C. Freezer

Precise Surface Disinfectant

Micro Glassware Disinfectant/Cleanser

Beaker (250 ml)

Betadine Disinfecting Solution

Syringes (1 cc) (Sterile)

Needles (Various Gauges)

Vacutainer Tubes (Red Tops and “Tiger Tops”)

MEDIA AND REAGENT PREPARATION

Prepare Agar:

Lower layer (2.5% working solution): Weigh out 2.50 gm of Bacto-Agar and place in a 100 ml capped bottle. Add 100 ml distilled water. Swirl gently to mix.

Upper layer (1.5% working solution): Weigh out 1.50 gm of Bacto-Agar and place in a 100 ml capped bottle. Add 100 ml distilled water. Swirl gently to mix. Place both bottles in the microwave with caps loosened. Microwave for 60 seconds at full power, mixing every 20 seconds. Avoid boiling. The agar will appear clear when ready. If solution boils over, do not use it. Re-make the agar solution. Loosely tape cap with autoclave indicator tape and autoclave both solutions for 20 minutes at 22 psi and 250°-270° F. Place both bottles in the water bath under the hood. This bath must be kept at 45°-50° C. at all times. The agar should cool down to 50° C. before use. Swirl agar to mix well before using.

Prepare Media:

After preparation of each media, label the final product with the following: 1) Name of Product; 2) Preparation Date; 3) Expiration Date; 4) Storage Recommendations; 5) Technologist’s Initials

10% RPMI 1640 (1×) G,G fortified:
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 (1X) with L-Glutamine
50.0 ml Fetal Bovine Serum, Qualified, Heat
Inactivated
5.0 ml L-Glutamine (100X) 200 mM
2.5 ml Penicillin/Streptomycin
2.0 ml Trace Element Mix (100X), Lyophilized
0.5 ml 2-Mercaptoethanol
5.0 ml Insulin-Transferrin-Sodium Selenite, Media
Supplement, Lyophilized, Gamma-Irradiated
______________________________________

Combine all components under a sterile laminar flow hood. Sterilize by filtration using a 0.22 micron cellulose acetate membrane filter with a 60 micron prefilter. Store the prepared media at 2°-10° C.

10% RPMI 1640 (2×) G,G Fortified:
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 (2X) Powdered Cell Culture Medium
with L-Glutamine (Reconstitute one powder
pack with a total of 500.0 ml of sterile
distilled water)
50.0 ml Fetal Bovine Serum, Qualified, Heat
Inactivated
5.0 ml L-Glutamine (100X) 200 mM
2.5 ml Penicillin/Streptomycin
2.0 ml Trace Element Mix (100X), Lyophilized
0.5 ml 2-Mercaptoethanol
5.0 ml Insulin-Transferrin-Sodium Selenite, Media
Supplement, Lyophilized, Gamma-Irradiated
______________________________________

Under a sterile laminar flow hood, measure out 450 ml of sterile distilled water and place in a sterile 500 ml reagent bottle. Add the powdered medium to the water with gentle stirring. Rinse out the inside of the package to remove all traces of powder. Add 1.0 g of NaHCO 3 per 500 ml of medium. Dilute with sterile distilled water to 500 ml. Adjust the pH of the preparation to 0.2-0.3 below the desired final working pH (pH units will usually rise 0.1-0.3 upon filtration); use of 1N NaOH or 1N HCl is recommended. After the pH has been adjusted, keep the container closed until the medium is filtered. Sterilize immediately by membrane filtration using a 0.22 micron cellulose acetate membrane filter with a 60 micron prefilter. Store the prepared media at 2°-10° C.

Prepare Lower Layer Stock Media:
______________________________________
125 ml Fetal Bovine Serum 125 ml 2 × G, G Fortified Solution 250 ml 1 × G, G Fortified Solution
______________________________________

Mix, label, and store at 2-10° C.

Prepare Upper Layer Stock Media:
______________________________________
150 ml Fetal Bovine Serum 150 ml 2 × G, G Fortified Solution 150 ml 1 × G, G Fortified Solution
______________________________________

Preparation of Drugs:

Prepare a working concentration for the drugs to be tested. All drug dilutions are made with RPMI 1640 1× G,G Fortified.

To prepare IFN Alpha-2a in a 10 ml capped tube, mix 0.1 ml Roferon (3,000,000 units/ml) with 9.9 ml 1× G,G, Media. Label tube with name of drug, preparation date, expiration date (1 week from the day of preparation), concentration (30,000 u/ml) and technician’s initials.

To prepare IL-2 in 10 ml capped tube: Remove working stock aliquot of IL-2 (10 units/ml) from refrigerator. If the aliquot is not available in refrigerator, follow the IL-2 aliquot procedure found in the aliquot procedure book. The stock tubes are kept in the -48° C. freezer. The dosage for testing will be 0.1 ml, which will equal 1 unit of interleukin-2. Therefore, 1 unit of interleukin-2 will be tested in the immunomodulatory procedure. Interleukin-2, in this media, can be maintained for 30 days at 2°-8° C.

To prepare LI-8-ABIFN (mAB to IFN alpha 2A) in a 10 ml capped tube, remove working aliquot (neutralizing effect of 1000 units/ml from freezer). The dosage will be 0.1 ml in the assay to achieve a concentration of 100 units of neutralizing ABIFN.

PROCEDURE:

Lower Layer (2.5% agar):

Use lower layer stock media and dispense 8 ml of stock media into the appropriate number of sterile 15 ml tubes with caps. (Approximately 8 plates can be made from 1 tube.) Keep capped at room temperature until needed to prepare lower layer plates or store capped overnight at 2°-8° C. for use the following day. Warm to room temperature before use. When ready to prepare the lower layer plates work quickly to prevent premature solidification of the agar. Using a sterile 10 ml pipet draw up 2.0 ml of the 2.5% agar mixture. Dispense the 2.0 ml into one of the 15.0 ml plastic tubes containing 8 ml of lower layer media, and mix twice by drawing up and dispensing into the tube. Draw up 9.0 ml of the mixture and dispense 1.0 ml into each 35 mm gridded plate. Swirl to cover the bottom of the plate. Take care to prevent bubbles. Prepare only 8 plates at a time so that the agar does not solidify before it is plated. Allow plates to sit undisturbed on a flat surface until the agar has solidified. Discard any plates with uneven agar distribution. Store plates at room temperature for same day use or overnight in a 37° C. CO 2 incubator for use the following day.

Preparing the Cells Lines:

Generally, L929 cells are used in the assay, but colon, prostate, breast or ovarian cells may also be used.

For L929 cells, microscopically examine the liquid culture flasks of the desired cell line and determine by confluency which flasks to use. Remove supernatant with pipet and discard. Add 5 ml Trypsin. Expose to cell layer and remove 2 ml. Incubate flasks with Trypsin for minute. Hit flask with the palm of your hand to knock cells off. Add 7 ml of L929 cell media to stop reaction. Transfer cells to a sterile 50 ml conical tube, add more media (to bring to 20 ml). Centrifuge tube 1600 RPM for 5 minutes with brake on 2. Remove supernatant and resuspend pellet in L929 cell media. Centrifuge cells at 1600 RPM for 5 minutes with brake on 2. Remove supernatant, resuspend pellet in appropriate media.

Preparing the Patient Cells (from whole blood with Calciparine, or BM Specimen with Calciparine):

Into an appropriate size (depends on sample volume) capped plastic tubes labeled with each patient’s name, dispense the appropriate volume of histopague (use equal amounts of histopaque to equal amounts of whole blood, i.e., if a whole blood tube containing 8 ml of blood is received, dispense 4 ml of histopaque and 4 ml of whole blood into each of two 15 ml capped tubes. If 75 ml of BM is received, dispense approximately 18.75 of histopaque and 18.75 of BM into four 50 ml conical tubes. Layer in the whole blood very slowly at a 45° C. angle on the histopaque. Centrifuge at 1600 RPM for 20 minutes in centrifuge at 4° C., brake on 2. Remove and discard the supernatant. Remove the cell interface and place in a separate tube containing 10.about. RPMI 1× G,G media. Dilute the cells with media quickly because the histopaque is very toxic to the cells if left on them for extended periods of time. Wash cells twice with 10.about. RPMI 1× G,G media. Centrifuge at 1600 RPM for 5 minutes with the brake on 2. Remove and discard the supernatant. Resuspend the cell pellet in 5 ml RPMI 1× G,G media.

PERFORM CELL COUNT:

In a 12×75 ml glass tube, combine: 0.7 Media; 0.2; Trypan Blue; and 0.1 Cell Suspension. This is a 1:10 Dilution. Mix well. Charge one chamber of the hemocytometer with the cell suspension. Under the light microscope, count the live cells (those which have not absorbed Trypan Blue) in the 4 corner 1 mm 2 squares. The concentration of cell lines and patient cells for the IM assay will be as follows (cells per ml):

L-Cells5×10 5

Colon1×10 5

Prostate5×10 4

Breast5×10 4

Ovarian2×10 4

Patient1×10 6

Count the total number of cells (stained and unstained) in the 4 corner 1 mm 2 squares.

CALCULATION FOR CELL COUNT:

Use the following cell count formula: Cells per ml=average # cells×dilution factor×hemocytometer factor.

EXAMPLE CALCULATION:

Patient cells are brought up in 10 ml of media. 0.1 ml of cells are added to 0.2 ml of Trypan Blue and 0.7 ml of media. 4-1 mm 2 squares were counted and cell count=80 cells. 20 cells (80 cells 4-1 mm 2 squares=average # of cells)×10 (dilution factor)×10 4 =2×10 6 cells/ml.

Calculate % viability using the following formula: % of viable cells×100=% viability total # of cells

Adjust volume to amount needed for the appropriate cell concentration for the assay: (V 1 C 1 =V 2 C 2 )

V 1 =10 ml V 2 =?

C 1 =2×10 6 cells/ml C 2 =1×10 6 cells/ml ##EQU4## 20 ml=V 2 20 ml-10 ml=10 ml

Ten ml of media must be added to have a volume of 1×10 6 cells/ml.

Label the appropriate number of plates with the following information: 1) Specimen number; 2) Patient name; 3) Name of BRM; 4) Setup date.

Preparing Upper Layer:

Label and arrange 15 ml sterile capped tubes for each control, patient serum, patient whole blood sample, that you need in a test tube rack according to Table 2 (infra.). Be sure to include a cell control, and a control for each BRM to be tested. The cell control should contain everything the others contain except for BRM. A separate set of control tubes must be set up for each cell line assayed (colon, L cell, prostate). Dispense the upper layer stock media into each tube, then add appropriate amounts of BRM, ABIFN, cell line and serum or patient whole blood. See Table 2 as follows:
TABLE 2
________________________________________________________ __________________
FOLLOW THIS TABLE FOR UPPER LAYER VOLUMES (ALL IN ml): PTWBC UPPER OR L AGAR TOTAL LAYER BRM ABIFN SERUM CELLS 1.5% VOLUME
________________________________________________________ __________________

CELL 2.1 — — — 0.3 0.6 3.0 ml
CONTROL
IFN 2.0 0.1 — — 0.3 0.6 3.0 ml
CONTROL
IL2 2.0 0.1 — — 0.3 0.6 3.0 ml
CONTROL
ABIFN
CONTROL 2.0 — 0.1 — 0.3 0.6 3.0 ml
PT. SERUM
1.9 — — 0.2 0.3 0.6 3.0 ml
PT. SERUM/
1.8 — 0.1 0.2 0.3 0.6 3.0 ml
ABIFN
PT. SERUM/
1.8 0.1 — 0.2 0.3 0.6 3.0 ml
IFN
PT. SERUM/
1.8 0.1 — 0.2 0.3 0.6 3.0 ml
IL2
PT. WBC 1.9 — — 0.2 0.3 0.6 3.0 ml
PT. WBC/
1.7 — — 0.2 0.3 0.6 3.0 ml
SERUM 0.2
PT. WBC/
1.6 — 0.1 0.2 0.3 0.6 3.0 ml
SERUM/ABIF 0.2
PT. WBC/
1.8 0.1 — 0.2 0.3 0.6 3.0 ml
IFN
PT. WBC/
1.6 0.1 — 0.2 0.3 0.6 3.0 ml
IFN/SERUM 0.2
PT. WBC/
1.8 0.1 — 0.2 0.3 0.6 3.0 ml
IL-2
PT. WBC/
1.6 0.1 — 0.2 0.3 0.6 3.0 ml
IL-2/SERUM 0.2
________________________________________________________ __________________

Add all components except agar to the appropriate tube. For the following, one tube should be finished before moving on to the next. With a 2.0 ml pipet, draw up 0.6 ml of 1.5% agar. Dispense the agar into the tubes one at a time, starting with tube #1. Mix by aspirating and dispensing twice. Draw up 2.2 ml of solution and dispense 1.0 ml into each gridded petri plate (on top of the other layer) taking care not to produce bubbles in the agar. Gently swirl plate to allow for even distribution. Allow agar to solidify, and then add distilled water (approximately 0.5 ml) to humidity plate and place in large labeled petri plate. Repeat steps 5-7 for each plate to be set up. Incubate the cultures at 37° C. in a humid, 5% CO 2 -enriched atmosphere.

REPORTING RESULTS:

Reading semi-solid culture plates:

Read the plates after 7 days as follows: Scan the plate for colonies and aggregates. If they are present, count all the squares to obtain the number of aggregates and colonies in the plate (aggregates=4-20 cells per cluster) (colony is >20 cells per cluster). If no colonies or aggregates are present, count all individual cells (cell line and patient’s WBC’s) in 4 squares and take the average. Multiply the average by 15×13.36 (15=# of square in the center row) (13.36=area of the plate). Plates may be read at 5, 6 or 8 days. Record all data in scientific notation on the report form.

Procedure 4

Human Interferon Assay

Interferons are cytokines that have the ability to inhibit the growth of viruses and to protect infected cells against viral cytopathic effects. The immunoregulatory functions of interferons such as the increase in natural killer (NK) lymphocyte activity, the increase in histocompatibility antigens, the activation of monocyte/macrophages, and B-cell function have also proven to be of clinical importance. The first natural interferon was discovered by Isaac and Linderman in 1975, and recombinant interferon alpha 2 was registered by the FDA in 1986 ushering in a new phase of biotherapy. The goal of this assay is to determine the level of interferon in international units/ml in patient’s serum. Potency of the human interferon of serum samples and controls will be determined using WISH cells challenged with Vesicular Stomatitis Virus measuring the cytopathic effect.

SPECIMEN REQUIREMENTS, COLLECTION AND HANDLING

Specimens are labeled with the following information: 1) Patient name; 2) Date drawn; 3) Time drawn; 4) Phlebotomist’s initials; 5) Test name.

Serum-Amount required: Optimum=3.0 ml Minimum=1.0 ml

The specimen must be aseptically collected in a “tiger” top vacutainer tube, allowed to clot, then centrifuged at room temperature for 10 minutes at 2000 rpm. The serum should be poured over into a sterile plastic tube, capped, appropriately labeled, and stored frozen until the assay is performed.

Plasmapheresis–Amount required: Optimum=3.0 ml Minimum=1.0 ml

The specimen must be collected using sterile technique into a 10 ml red top vacutainer tube from the plasma bag obtained during the plasmapheresis procedure. Add 2500 units of calciparine to the 10 ml red top vacutainer tube containing the plasmapheresis sample and mix well. In addition to the information required above, the specimen should be labeled with the bag number from which it was obtained, i.e. #1, #2, etc. The specimen must be poured over into a sterile plastic tube, capped, appropriately labeled, and stored frozen until the assay is performed.

EQUIPMENT:

The following equipment is needed for this procedure:

Sterile laminar flow hood with ultra-violet light

Freezer -70° C.

Refrigerator 2°-8° C.

Autoclave

Analytical balance

Refrigerated centrifuge

CO 2 incubator

Spectrophotometer (Bio-Rad 96-well plate reader with 540 nm filter)

96-well microtiter plates–sterile flat bottom with covers Falcon 3872

Pipet aid

Micropipettes

Costar octapettes–50 ul, 100 ul, & 200 ul

Wheaton multi-channel pipet–50-200 ul range

MLA-40 ul

Sterile disposable:

Pipettes (1 ml, 5 ml, 10 ml, and 25 ml)

Pipet tips Wheaton 851247

Plastic troughs

Gauze

Cryovials

50 ml conical tubes with caps

Test tubes

Culture flasks (75 cm and 150 cm)

Kimtex wipers

Biohazardous waste can and bags

Stainless steel pan with cover

MATERIALS:

The following materials are needed for this procedure:

Basal Medium Eagle 1× (BME), 500 ml Gibco Cat. No. 320-1010AJ

Fetal Bovine Serum, 100 ml Hyclone Cat. No.

A-1111-D

L-Glutamine, Cat. No. 320-5030AG

Hepes Buffer Solution (1M), 100 ml Gibco Cat. No. 380-5630AG

Penicillin/Streptomycin

WISH cells (Human Amnion) ATCC 25-CCL

Vesicular Stomatitis Virus ATCC

Human Interferon (alpha) Reference NIAID Cat. No. Ga23-902-530

Gamma Interferon control

Neutral red dye Sigma No. N-2880

Phosphate buffered saline (PBS)

PBS without Ca++ and Mg++, Ph 7.4 Gibco

Cat. No. 310-4190AJ

PBS with Ca++ and Mg++, Ph 6.8 Gibco

Cat. No. 310-4040AJ

Glacial acetic acid Sigma Cat. No. A-6283

Distilled water

Ethyl Alcohol Aldrich Cat. No. 18,738-0

Patient sera

One-Stroke Environ Calgon Vestal No. 539708

Trypsin-EDTA 1×, 100 ml Gibco Cat. No. 610-520OAG

Trypan Blue Gibco 6305250AG

REAGENT PREPARATION:

All media must be filtered for sterility, labeled with name, preparation and expiration dates, storage information, and technician’s initials. Prepared media is stable for three months at 2°-8° C.

BME with 15% FBS:

Add 75 ml of FBS, 5.0 ml Pen/Strep 10 ml glutamine, and 5 ml hepes to a 500 ml bottle of BME. (For feeding WISH cells.)

BME with 10% FBS:

Add 50 ml of fetal bovine serum, 2.5 ml Pen/Strep, 10 ml glutamine, and 5 ml hepes to a 500 ml bottle of BME.

BME with 2% FBS:

Add 10 ml of FBS, 2.5 ml Pen/Strep, 10 ml glutamine, and 5 ml hepes to a 500 ml bottle of BME.

Vesicular Stomatitis Virus (VSV):

Prepare two 150 cm 2 culture flasks of WISH cells. Discard the media when the cells become confluent. Wash once with fresh BME with 2% FBS. Dilute a VSV stock preparation 1000 times with BME with 2% FBS. Inoculate 8-10 ml per flask of the 1:1000 VSV into each WISH cell flask such that it covers the entire cell layer. Incubate the flasks for 1 hour at 37° C. in a 5% CO2 incubator. Add 15 ml of the BME with 2% FBS to each flask and incubate at 37° C. in a 5% CO2 incubator for 1-3 days or until cell layers show nearly complete viral cytopathic effect (CPE). Harvest the culture fluid and clarify by centrifugation at 3000 RPM for 20 minutes at 4° C. Aliquot the virus containing supernatant into 10 ml tubes and store at -70° C. This virus stock usually contains 1×10 9 plaque-forming units/ml when its infectivity is quantitated in WISH cells. Dilute one 10 ml stock VSV tube 1:10 with BME with 2% FBS to yield a working VSV of 1×10 8 plaque forming units/ml. Aliquot 1 ml of working VSV into cryovials and store at -70° C. Dilutions of 1:100, 1:200, and 1:300 of working VSV should be made and inoculated onto confluent WISH cells in a 96-well plate to determine the dilution that yields nearly 100% CPE in 24-48 hours.

Human Alpha Interferon (National Institute of Health: catalog #Ga23-902-530):

Reconstitute with 1.0 ml of sterile distilled water being careful to avoid any loss of material in the neck of the ampule. Dilute to a concentration of 105 IU/ml of interferon with BME with 2% FBS (no Pen/Strep and no hepes). Aliquot 200 ul into cryovials and store in -70° C. freezer. The aliquots are stable for two years at this temperature.

Neutral Red Dye:

Prepare 0.1% stock solution of Neutral Red Dye by adding 500 mg of red dye powder to 500 ml of distilled water. Mix with magnetic stir bar at room temperature for 1 hour. Autoclave for 10 minutes at 15 psi. Cool. Label and store stock Neutral Red Dye in a brown bottle and refrigerate. Staining Solution–prepare a 15% staining solution by adding 85 ml PBS with Ca + + and MG + + (Ph 6.85) to 15 ml stock Neutral Red Dye.

Eluting Solution:

To 1 ml glacial acetic acid add 49 ml distilled water and 50 ml 100% ethanol. Label and store in glass capped bottle at room temperature.

Gamma Interferon Control:

Obtain Actimmune (3.0×10 6 units/ml). Dilute 0.05 ml (50 ul) of Actimmune with 49.95 ml of BME with 2% FBS and mix well to obtain a concentration of 3000 units/ml. Aliquot 10 ml into each of 5 sterile capped tubes and label with “stock IFN gamma,” 3000 units/ml, preparation and expiration dates. (Stable for 2 years at -70° C.). Dilute 1 ml of stock IFN gamma with 9.0 ml of BME with 2% BME for a working concentration of 300 units/ml. Aliquot 200 ul of this concentration into cryovials, label, and store at -40° C. (Stable for 2 years.). Run in parallel with current control to obtain range prior to putting into use.

PROCEDURE:

Day One:

Generate a worksheet from the interferon data base for 24 samples. Number the worksheet with #1 as the reference, patient samples #2-#25, the gamma control #26, and the alpha control #27. Retrieve the patient samples, interferon reference and controls from the freezer. Verify samples with the worksheet. Label nine sterile 96-well microtiter plates with sample numbers (run in duplicate), plate number and date. Two 150 cm 2 flasks of confluent WISH cells are harvested and washed by the liquid culture technician. The tube of cells is labeled with the name of the cells, the passage number, date, and technician’s initials. Note: The passage of WISH cells should be less than P250. Before this passage is reached, cells of younger passage should be retrieved from liquid nitrogen and started in liquid culture.

Perform the cell count in the following manner: in a 12×75 ml tube, combine 0.5 ml of WISH cells and 0.5 ml of 0.4% Trypan Blue (1:2 dilution). Mix well and charge the hemacytometer chamber. Under the light microscope, count the viable WISH cells in the four corner 1 mm 2 squares and divide by 4 to obtain the average for 1 square. Count the total number of cells in the four corner 1 mm 2 squares and divide by 4 to obtain the average for 1 square. Determine the % viability by dividing the viable cell count by the total cell count and multiplying by 100. Record the % viability on the cell count worksheet.

Determine the number of cells/ml by using the following equation: Avg. # of viable cells/square×dilution factor×hemacytometer factor=cells/ml

Dilute the WISH cells to 3.5×10 5 cells/ml according to the following formula: V 1 C 1 =V 2 C 2

For example:

Volume 1 =40 ml Concentration 1 =2.0×10 6

Volume 2 =? Concentration 2 =3.5×10 5 ##EQU5## V 2 =229 ml

Add 189 ml of BME with 10% FBS to the original volume of 40 ml to obtain 3.5×10 5 cells/ml. Set aside diluted WISH cells until ready to be added to the microtiter plates. Using sterile techniques, add 100 ul of 10% BME to each well (including blanks) of the 96-well microtiter plates. To the wells in column #1, B-G, add an additional 60 ul of 10% BME. To well positions B1 and C1 of plate #1 (each sample will be run in duplicate) add 40 ul of the reference. To well positions D1 and E1 add 40 ul of patient serum. To each successive pair of wells, add 40 ul of the appropriate patient serum. In addition to the patient samples, set up a gamma interferon control and an alpha interferon control (reference) on the last plate of the assay. Make serial dilutions with the 100 ul octapet from column 1 to column 10 and rows B-G by mixing up and down several times, then carrying 100 ul to the next column through the 10th column. Discard the remaining 100 ul from the 10th column. Add 100 ul of the 3.5×10 5 cells/ml WISH cell suspension to all wells except blank wells in rows A and H. Designate column 11 as cell control and column 12 as viral control on each plate. Incubate plates 18-24 hours at 37° C. at 5% CO 2 . Lay out the stainless steel pan containing OneStroke Environ, diapers and gauze squares in hood with white light overnight.

Day Two:

Check plates under the inverted microscope for confluency. Check for toxicity of patient sera (black edges). Using sterile techniques, dump the media from the plates into the stainless steel pan containing OneStroke Environ, blot on gauze. Wash the cells by adding 100 ul of BME with 2% FBS to all the wells except the blank wells, dump, and blot. Add 50 ul of 2% BME to column 11. Add 100 ul of 2% BME to all wells (including blanks). Add 50 ul VSV (in a concentration that yields 90% CPE in the viral control in 24-48 hours) to all the sample wells in columns 1-10 and column 12. Incubate 24-48 hours at 37° C. with 5% CO 2 .

Day Three:

Check plates under the microscope for 90-100% CPE in the viral control. Look for 50% CPE in the reference and samples. The 50% CPE should fall between columns 4 and 6 for the reference. Incubate plates until this is achieved. Place the stainless steel pan containing One-Stroke Environ along with Kimtex wipers sufficient for blotting the plates under the hood. Dump plates and blot. Add 100 ul of 15% neutral red dye to all the sample wells. Incubate at 37° C. with 5% CO 2 for 45 minutes. Dump plates and blot. Rinse with 200 ul PBS at pH 6.85. Dump and blot. Plates may be left to dry inverted on Kimtex wipers on a tray for several days before eluting. Elute by adding 100 ul of the eluting solution to each sample well.

Read on the microplate reader with a 540 nm filter. Select Microman from the menu to access the Microplate Manager program. Under Analysis, select Multiple Readings.

Select:

Single Wavelength

540 nm

Mixing duration–5 seconds

Reading per plate–1

Number of plates–9

Filename–date (i.e., 0722)

Remove cover of microtiter plate #1 and place in the reader. Select Start. After all the plates have been read, print the raw data reports as follows: Under file, select Open and Lotus Results. Arrow down to filename, or type in the file name and plate number. Select Open. If message appears “Save current results . . . ,” say NO. When Raw Data Report appears on the screen, under File, select Print. Select Raw Data Report and OK. Under file select Close. Repeat for each plate to be printed.

RESULTS:

A. Average the optical density (O.D.) values for the cell controls (column 11) and viral controls (column 12).

B. Average the O.D. values for the duplicates of the patients and reference samples–i.e. average B & C for each column 1-10, average D & E for each column 1-10, etc.

C. To determine the O.D. at 50%: ##EQU6##

D. To enter the O.D. values and their corresponding IFN dilutions:

1. Enter the 1st average O.D., press X-Y

2. Enter corresponding 1st IFN dilution, press LOG, then Ε+

3. Enter the 2nd average O.D., press X-Y

4. Enter corresponding 2nd IFN dilution, press LOG, then Ε+

5. Enter the 3rd average O.D., press X-Y

6. Enter corresponding 3rd IFN dilution, press LOG, then Ε+

E. To determine the correlation coefficient (r):

1.Press 2nd, then CORR (÷)

2. The correlation coefficient (r) should be -1.0±0.1.

3. Enter O.D. 50%, press 2nd, then y’ (x)

F. To convert the titer (log 10) to units/ml, press INV, then LOG

G. To clear data, press 2nd, then STO, then CE/C

H. To convert IFN units/ml to International Reference Units/ml:

1. IFN units/ml of Reference=Factor Int’l Ref. Units/ml of Reference

2. Sample IFN units/ml=Sample titer (IRU/ml) Factor

Procedure 5

Human Tumor Colony-Forming Chemosensitivity Assay

(Pharmacosensitivity)

The Human Tumor Colony Assay (HTCA: clonogenic or tumor stem cell assay) is an in vitro culture system employing semi-solid medium support originally described by Salmon and Hamburger, et al. Using HTCA, the growth and chemosensitivity of clonogenic tumor cells present in fresh biopsy specimens of human tumors can be investigated. Since this technique was first described, there has been a marked increase in the direct study of human tumors in vitro. Excellent evidence has been obtained which establishes that colonies grown in HTCA are comprised of tumor cells and that clonogenic cells within tumor colonies have the property of self-renewal (the defining property of a tumor stem cell). Chemosensitivity testing with specific agents in HTCA has documented striking degrees of heterogeneity in drug sensitivity from patient to patient, even for tumors of the same histopathology. Clinical correlations have been made between in vitro chemosensitivity and the response of patients with metastatic cancer to chemotherapy. In a series of trials, HTCA has had a 71% true-positive rate and a 91.about. true-positive rate for predicting the drug sensitivity and resistance, respectively, of cancer patients to specific chemotherapeutic agents. The assay thus appears to be a prognostic factor which identifies chemosensitive patients and which may allow some individualization of chemotherapy.

Tumor specimens, either from solid tumor masses, malignant ascites, or bone marrow are mechanically disaggregated into a suspension which is as close to a “single-cell suspension.about.as possible. These cells along with chemotherapeutic agents, biological response modifiers, and hormones are suspended in an agar-containing culture medium and then layered or “plated” onto a semi-solid underlayer. The underlayer prevents normal human fibroblasts, a major tumor stromal component, from adhering to the culture dish bottom and forming colonies which might be confused with colonies of tumor-cell origin. After 7 days, 14 days, and 21 days of incubation in a humid, CO2-enriched atmosphere at 37° C., colonies (greater than 20 cells) and aggregates (4-20 cells) are counted. A negative control and a positive control are set up for each tumor. From this data the effect of each specific drug on the tumor can be determined.

SPECIMEN REQUIREMENTS, COLLECTION AND HANDLING:

This assay may be performed on the following specimen types:

Solid tumors obtained during surgery or biopsy

Bone marrow aspirates and biopsies

Ascites

Pleural fluids

Thoracentesis fluids

The sample should be sufficient to yield an optimum of 20 ml of 1.0×10 6 viable cells/ml. A minimum of 12 ml of 1.0×10 6 viable cells/ml is acceptable. All specimens should be labeled with patient name, collection date, tumor type, and initials of technician.

MATERIALS:

The following materials are needed for this procedure:

Laminar Flow Hood

Bacto-Agar

Analytical Balance

Weighing Paper

Weighing Tools

Sterile Capped Bottles (100 ml, 250 ml, 500 ml; and 1,000

Distilled Water

Microwave Oven

Autoclave

RPMI 1640 Media (1× and 2×)

HCL (1N)

Sodium Bicarbonate

Penicillin/Streptomycin

Disposable Pipettes (sterile) (1 ml; 2 ml; 5 ml; 10 ml, 25 ml)

Select-A-Pette Pipetter (1 ml)

Select-A-Pette Tips (sterile)

Eppendorf Pipettes

Eppendorf Combitips (sterile) (2.5 ml; 5.0 ml; 12.5 ml)

Glutamine

Trace Elements

2-Mercaptoethanol With Dulbecco’s PBS

ITS Solution

Fetal Bovine Serum

Test Tubes (12×75 Glass-disposable; 15 ml Capped-sterile and disposable)

Petri Dishes (sterile) (Routine-100×15 mm; Gridded Plates-35×10 mm)

Sterile Capped 50 ml Conical Tubes (Falcon)

Homogenizer

Trypan Blue Stain (0.4.about.)

Hemocytometer With Cover Slips

Microscopes (Inverted; Light)

Hand Tally Counter

Ph Paper (narrow spectrum)

Graduated Cylinders (50 ml and 100 ml)

Histopaque-1077

Water Bath

Pipet Suction Aide

Refrigerated Centrifuge

Liquid Culture Flasks (25 cm 2 )

CO 2 Incubator

Chemotherapeutic Drugs

Biological Response Modifiers

Hormones

Vortex Mixer

Refrigerator (2°-10° C.)

Scalpel (disposable and sterile)

Sharps Container Pasteur Pipettes 53/4″ (disposable)

Dropper Bulbs

-70° C. Freezer

Precise Surface Disinfectant

70% Alcohol In Squeeze Bottle

Contrad Glassware Disinfectant/Cleanser

Thermometer (-20° C.-120° C.)

Beaker (500 ml)

Betadine Disinfecting Solution

Syringes (disposable and sterile) (1 cc; 10 cc)

Needles (various gauges)

MEDIA AND REAGENT PREPARATION:

Agar:

Lower layer=2.5% working solution: Measure out 2.5 gm of Bacto-Agar and place in a 100 ml capped bottle. Add 100 ml distilled water. Swirl gently to mix.

Upper layer=1.5% working solution: Measure out 1.50 gm of Bacto-Agar and place in a 100 ml capped bottle. Add 100 ml distilled water. Swirl gently to mix.

Place both bottles in the microwave with caps loosened. Microwave for 60 seconds at full power, mixing every 20 seconds. Avoid boiling. The agar will appear clear when ready. If the solutions boil over, do not use, remake the agar. Place a piece of autoclave tape on each of the loosely capped bottles and autoclave the solutions for 20 minutes at 22 psi. Place both bottles in the water bath under the hood. THIS BATH MUST BE KEPT AT 45°-50° C. AT ALL TIMES. The agar should cool down to 50° C. before use. Swirl agar to mix well before using. After preparation of each media, label the final product according to procedures previously described.

MEDIA:

10% RPMI 1640 (1×):
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 (1X) with L-Glutamine
50.0 ml Fetal Bovine Serum, Qualified, Heat
Inactivated
5.0 ml L-Glutamine (100X) 200 mM
1.5 ml Penicillin/Streptomycin
2.0 ml Trace Element Mix (100X) Lyophilized
0.5 ml 2-Mercaptoethanol
5.0 ml Insulin-Transferrin-Sodium Selenite
Media Supplement, Lophilized, Gamma-
Irradiated
______________________________________

Combine all components under a sterile laminar flow hood. Sterilize by filtration using a 0.22 micron membrane filter with a 60 micron prefilter. Label and store the prepared media at 2°-10° C.

10% RMPI 1640 (2×) G,G Fortified:
______________________________________
AMOUNT COMPONENT
______________________________________

500.0 ml RPMI 1640 (2X) Powdered Cell Culture
Medium With L-Glutamine (Reconstitute
one powder pack with a total of 500.0 ml
of sterile DISTILLED WATER)
50.0 ml Fetal Bovine Serum, Qualified, Heat
Inactivated
5.0 ml L-Glutamine (100X) 200 mM
2.5 ml Penicillin/Streptomycin
2.0 ml Trace Element Mix (100X) Lyophilized
0.5 ml 2-Mercaptoethanol
5.0 ml Insulin-Transferrin-Sodium Selenite
Media Supplement; Lophilized; Gamma-
Irradiated
______________________________________

Under a sterile laminar flow hood, measure out 450 ml of sterile distilled water and place in a sterile 500 ml reagent bottle. Add the powdered medium to the water with gentle stirring. Rinse out the inside of the package to remove all traces of powder. Add 1.0 G OF NaHCO 3 per. 500 ml of medium. Dilute with sterile DH 2 O to 500 ml volume. Adjust the pH of the preparation to 0.2-0.3 below the desired final working pH of 7.2 (pH units will usually rise 0.1-0.3 upon filtration); use of 1N NaOH or 1N HCl is recommended. After the Ph has been adjusted, keep the container closed until the medium is filtered. Sterilize immediately by membrane filtration using a 0.22 micron membrane filter with a 60 micron prefilter (positive pressure is recommended). Label and store the prepared media at 2°-10° C.

Lower Layer Stock Media:

125 mlFetal Bovine Serum

125 ml2×G,G Fortified Solution

250 ml1×G,G Fortified Solution

Mix, label, and store at 2°-10° C.

Upper Layer Stock Media:

150 mlFetal Bovine Serum

150 ml2×G,G Fortified Solution

150 ml1×G,G Fortified Solution

Mix, label, and store at 2°-10° C.

Preparation of Drugs:

Working aliquots of each drug, hormone, and biological response modifier are prepared every two weeks according to the aliquot procedure. The working aliquots are stored at 4° C. and are ready for use.

PROCEDURE:

Prepare the Lower Layer Tubes:

Pipet 8 ml of lower layer stock media into 15 ml sterile capped tubes. (NOTE: Determine the number of plates needed by multiplying the number of drugs on the testing panel ×2. One lower layer tube yields approximately 8 lower layer plates.) Keep capped at room temperature until needed to prepare lower layer plates or store capped overnight at 28° C. for use the following day. Be sure to warm to room temperature before use.

Plate the lower layer plates as follows (WORK QUICKLY TO PREVENT PREMATURE SOLIDIFICATION OF THE AGAR): With a sterile 10 ml pipet, draw up 2.0 ml of the 2.5% agar mixture. Dispense the 2.0 ml of agar into one of the 15.0 ml plastic tubes containing 8 ml of lower layer media and mix twice by drawing up and dispensing into the tube. Draw up 9.0 ml of the mixture and dispense 1.0 ml into each of eight sterile 35 mm gridded plates. Swirl to cover the bottom of the plate. Take care to prevent bubbles. Allow plates to sit undisturbed on a flat surface until the agar has solidified. Discard any plates with uneven agar distribution. Store plates at room temperature for same day use or store overnight ln a 37° C. CO2 incubator for use the following day.

Prepare the Cell Suspension:

Solid tumor: In a sterile petri dish, using sterile scalpel and forceps, cut the tumor specimen into pea-size portions. Save the original transport media for centrifugation. Place the specimen in a glass conical tube that has a matched loose-fitting homogenizer. Add 5.0 ml of transport media. Gently homogenize the tumor pieces a small portion at a time and transfer the cell suspension to a sterile 50 ml conical tube. When all of the tumor has been homogenized, mix well and then allow cell suspension to settle, undisturbed, for one minute (this will allow clumps of tissue to settle out). Pipet the supernatant into a sterile tube, dilute with RPMI 1× with 10% FBS and centrifuge at 1600 RPM for 5 minutes. Remove the supernatant, resuspend the cells in RPMI 1× with 10% FBS, and perform cell count and viability.

Liquid tumor (ascites, bone marrow, etc.): Using a sterile pipet, dispense 20-25 ml of histopaque into the appropriate number of capped sterile 50 ml conical tubes. Using another sterile pipet, gently layer the ascites, bone marrow or cell suspension at a 45° C. angle onto the histopaque using a 1:1 ratio of histopaque to specimen. Centrifuge at 1600 RPM for 20 minutes in the refrigerated centrifuge at 4° C. (brake on 2). Remove and discard the supernatant. Remove the cell interface and place in RPMI (1×) GG fortified in a pre-labeled tube. DILUTE THE CELLS WITH THE MEDIA QUICKLY BECAUSE THE HISTOPAQUE IS VERY TOXIC TO THE CELLS IF LEFT ON THEM FOR EXTENDED PERIODS OF TIME. Wash cells twice with RPMI 1640 (1×) media and centrifuge at 1600 RPM for 5 minutes with a brake of 2. Remove and discard the supernatant. Resuspend the cell pellet in 5 ml of RPMI 1× medium.

Perform Cell Count:

In a 12×75 ml glass tube, combine:

0.1 ml of well-mixed cell suspension

0.2 ml of 0.4% Trypan Blue stain

0.7 ml of media

This is a 1:10 Dilution.

Mix well and charge one chamber of the hemocytometer with the cell suspension. Under the light microscope, count the viable tumor cells (those which have not absorbed the Trypan Blue) in the four corner 1 mm 2 squares. Count the total number of tumor cells (stained and unstained) in the four corner 1 mm 2 squares.

Calculation for Cell Concentration:

Perform the viable cell count using the following equation: Average # of viable cells per square×dilution factor×hemacytometer factor

Sample calculation: 20 Cells (average # of viable cells per square)×10 4 ×10 (dilution factor)=2×10 6 cells/ml.

Determine the % viability using the following formula: ##EQU7##

Adjust volume to amount needed for the appropriate cell concentration for the assay (this assay requires 1×10 6 cells/ml) using the following formula: (V 1 C 1 =V 2 C 2 )

For example:

V 1 =10 ml V 2 =?

C 1 =2×10 6 cells/ml C 2 =1×10 6 cells/ml ##EQU8## 20ml=V 2 20 ml-10 ml=10 ml

Ten ml of media are needed to have a volume of 1×10 6 cells/ml.

Prepare Upper Layer Tubes:

Pull and arrange the prepared drugs that are to be tested against the tumor cells. Label the appropriate number of 15 ml capped tubes with the names of the drugs. Arrange the tubes in a test tube rack. Use the Table 3 as follows for upper layer volumes (all in ml):
TABLE 1
______________________________________
UPPER LAYER AGAR MEDIA CELLS DRUGS 1.5%
______________________________________

CONTROL 2.1 0.3 — 0.6
ABRIN 1.8 0.3 0.3 0.6
DRUG #1 1.8 0.3 0.3 0.6
DRUG #2 1.8 0.3 0.3 0.6
DRUG #3 1.8 0.3 0.3 0.6
______________________________________

Add all components except agar to the appropriate tubes. For the following steps, one tube should be finished before moving on to the next. With a 2.0 ml pipet, draw up 0.6 ml of 1.5% agar. Dispense the agar into the tube, one at a time, starting with tube #1. Mix by aspirating and dispensing twice. Draw up 2.2 ml of the solution and dispense 1.0 ml into each of two gridded plates (on top of the other layer) taking care not to produce bubbles in the agar. Gently swirl plate to allow even distribution. Allow agar to solidify undisturbed, and then add approximately 0.5 ml of distilled water to a third “half plate” in the large petri dish labeled with the corresponding drug. Repeat steps 5-7 for each drug to be tested. Incubate the cultures at 37° C. in a humid, 5% CO 2 enriched atmosphere.

Liquid Culture:

With the remaining cell suspension liquid cultures as follows: Label two 25 cm 2 liquid culture flasks. Add RPMI 1640 1× Fortified plus FBS and cell suspension to the flasks as follows:
______________________________________
MEDIA CELLS
______________________________________

25 cm 2 4.0 ml 0.5-1.0 ml
______________________________________

Incubate the cultures at 37° C. in a humid, 5% CO 2 enriched atmosphere. Leave the caps loose for CO 2 exchange.

DNA Analysis:

If requested by the physician, save at least 1 ml for DNA. (NOTE: The cells do not need to be alive for DNA testing.) Label the tube with the patient name, date, specimen type, and tracking number and place in the DNA beaker in the refrigerator.

Liquid Nitrogen:

Prepare a minimum of 2 cryovials for long-term storage in liquid nitrogen according to the freezing protocol.

Immunomodulation:

If requested by the physician, save at least 2.0 ml for the assay and store refrigerated until the IM assay is performed.

Reporting Results:

Within 24 hours after setting up the pharmacosensitivity, read the cell control and abrin plates under the inverted scope. Scan the plates in entirety. Count any clumps of cells and record as a background count on the worksheet. Always scan the entire plate for colonies and aggregates using a hand tally counter to record the number of each. If no colonies or aggregates are present, count the number of cells in four squares. Divide by 4 to obtain the average number of cells in one square, multiply by 15, then by 13.36 to obtain the number of cells in the entire 35 mm plate. Use scientific notation to report the colonies, aggregates and/or cells for any number greater than 3 digits. Representative colonies, aggregates, and/or cells must be photomicrographed and logged in the log book prior to discarding plates. Verify that controls fall within expected range. If not, document in the comment section and notify the Supervisor immediately. Do not discard the assay; it may be accepted at the discretion of the Medical Director.

Experiment 1

Activity of N. sativa on bone marrow cells

Preparation of N. sativa:

1. Dried seeds are finely ground, and 5 grams (5 g) of the powder is extracted with 95% ethanol 3 times, by soxhlet extraction. A Wheaton soxhlet extraction apparatus consists of 3 parts: the bottom part is the flask in which the 95% ethanol is heated; the middle portion is the extractor; and the top the Allihn condenser, in which there is an inlet and outlet for running cold water through the condenser. Dried N. sativa seed powder is packed in filter paper and placed in the extractor.

2. The pooled extracts are evaporated under reduced pressure to a known volume of 10 ml and loaded onto a silica gel (Keiselgel 60: Fluka) column and eluted with 95% methanol/water (9:1). In the column, silica gel suspended in methanol/water is layered on sand. N. sativa extract is added on top of the silica gel, followed by the eluting solvent.

3. The active fraction (as indicated by brown color) is collected and separated by preparing thin layer chromatography (TLC). On commercially available chromatography plates, a band of N. sativa active compound is spotted and run in a TLC jar using chloroform as the solvent system.

4. The active spot at the solvent front is removed, eluted with methanol (overnight), and evaporated under reduced pressure to render the product alcohol free.

5. The extract is then available as a soluble solution and is then stored at 2° C.

The approximate content of the active compound in the seed in 2.2% (w/w).

Calculation of active compound in N. sativa extract proceeded as follows: the active compound present in seed extract is 2.2% w/w. One gram of seeds was added to 10 ml assay media. Therefore, active compound added was 22 mg/ml media. Finally 40 μl from this was taken for assay. Hence, the active compound actually added was 88 μg. This was further diluted 1:10, 1:100 and 1:1000 to have a working concentration of 8.8 μg, 880 ng and 88 ng respectively.

Colony Forming Unit Assay

Specimen: Bone marrow sufficient to yield an optimum of 5.0 ml mononuclear cells at a concentration of 1.0×10 6 cells/ml was collected.

Assay: The assay was performed according to a modified process Metcalf (1984, 1985), which is incorporated herein by reference. The process is described in detail above in Procedure 2. To each 25 cm 2 flask, 1×10 6 bone marrow cells are added, and incubated at 37° C. with 5% CO 2 and 100 μl of N. sativa plant extract.

Immunofluorescence Staining of Cells: The peripheral blood cells were collected aseptically. For every panel of analysis 3.0 ml whole blood was needed. The assay was conducted according to processes disclosed in and partially modified from Karen (1989) and Merkel et al. (1987), which are incorporated herein by reference. The process is described in detail above in Procedure 1.

The N. sativa plant extract was incubated with peripheral blood cells from cancer patients over an 18 hour period at 37° C. in a 5% CO 2 incubator. Gates for the antibodies CD3, CD19, HLADR, LAK CD3+/CD56+, NK CD3-/CD56+, CD38, CD37, and CD33 surface markers were set on a Becton Dickinson FacScan serial No. 81326. These antibodies are designed to assist in the characteristics of the types of cells. The cluster designation (CD) is used to group two or more mABs that have statistically similar expression on normal and neoplastic cells and cell lines, as well as similar recognition of the same antigen or binding site (epitope). While mABs in a CD group usually define different epitopes on the same antigen, some CD groups, primarily non-lymphoid clusters, contain mABs that do not bind to the same antigen.

The results obtained from Experiment 1 were compared with that of bone marrow growth factors and biological response modifiers namely GM-CSF, G-CSF, erythropoietin, interferon, IL-2 and STS.

At days 7, 14 and 21, each flask was scanned under a Reichart Jung Biostar inverted microscope. A colony is defined as 40 or more cells adhering to the bottom of the flask.

The colony forming cell unit (CFU) assay on 1×10 6 bone marrow cells obtained from 2 cancer patients was performed with and without incubation with 100 μl of N. sativa plant extract.

Results: The colony forming cell unit assay on 1×10 6 bone marrow cells post 15 days incubation with 100 μl of plant extract showed a 600% elevation. This elevation was 125% after 21 days of incubation. Among the different growth factors/biological response modifiers, IL-2 and GM-CSF gave the maximum elevation of 120 and 115% after incubation with bone marrow cells for 15 days. There was not much detection of CFU elevation post 21-day incubation with growth factor/biological response modifiers. Interferon showed marginal elevation after a 15-day incubation, but negligible detectable response after 21 days.

N. sativa plant extract helps restore the immune competent cells in immunosuppressed cancer patients. The colony forming cell unit assay indicates increase in CFU count when bone marrow cells from cancer patients were incubated with N. sativa plant extract as well as with different growth factors indicating that N. sativa plant extracts mimic the potential application of these several growth factors. Even though the plant extract was used without dissolving, it had no toxic effects against human bone marrow cells. Hence, N. sativa plant extract helps restore the immune competent cells in immunosupressed cancer patients and over-stimulates bone marrow in normal individuals.

Experiment 2

Correlation Between Elevation in Immune Competent Cells/Hematopoiesis and
N. sativa Extract

Immunomodulatory Testing

Immunomodulatory testing evaluates the activity of patients’ sera and white blood cells in relation to interferon, interleukin and lymphokine demonstrating the presence of interferon inhibitor factor and lymphokine inhibitor factor in the experimental procedure. A detailed description of immunomodulatory testing is found above in Procedure 3.

To test for possible correlation between elevation in immune competent cells/hematopoiesis and N. sativa extract, the various surface markers of immune competent cells were analyzed by automated flow cytometry as described above in Procedure 3.

The results indicate an elevation in CD19, HLADR, NK CD3-/CD56+ and CD38 population. There was not much alteration in CD3, CD37 and CD33 surface marker index. A proliferation of connective tissue `L` cells was observed upon incubation with cancer patient serum and N. sativa extract at 37° centigrade in 5% CO 2 incubator for 7 days.

Cell Line: The mouse connective tissue L929 cells were obtained from the ATCC and grown in MEM medium (GIBCO) with 20% fetal equine serum (BioWhittaker) as described above.

Assay: The assay was conducted according to the process described in Medenica, et al. (1990), which is incorporated herein by reference. Proliferation of 5×10 5 `L` cells/ml was checked on a double layer agar procedure in which lower 1.5% agar layer media contained 125 ml FBS, 125 ml 2× G.G. fortified solution and 250 ml 1× G.G. fortified solution. The upper layer stock media contained 150 ml FBS, 150 ml 2× G.G. fortified solution and 150 ml 1× G.G. fortified solution. To 2.0 ml of upper layer, 0.1 ml of N. sativa extract, 0.3 ml of `L` cells and 0.6 ml of 1.5% agar was added to make a total volume 3.0 ml. Growth of `L` cells were analyzed under an inverted microscope type Reichert Jung biostar post incubation at 37° centigrade and 5% CO 2 after 7 days.

The results are illustrated in Table 4 as follows:
TABLE 4
______________________________________
CELL % INCUBATION MIXTURE NUMBER ELEVATION
______________________________________

`L` CELLS & MEDIA 2.0 × 10 4
0
`L` CELLS & IFN & MEDIA
2.7 × 10 4
35
`L` CELLS & IL-2 & MEDIA
2.3 × 10 4
15
`L` CELLS & SERUM & PLANT
4.7 × 10 4
135
EXTRACT
`L` CELLS & WBC & PLANT
7.4 × 10 4
270
EXTRACT
______________________________________

Connective tissue `L` cells at a concentration of 5×10 5 were incubated with IFN, IL-2 or plant extract at 37° C. in a humid 5% CO 2 incubator for 7 days. The SD of the data was <10%.

Results: Peripheral blood cells from cancer patients upon incubation with N. sativa extract over an 18-hour period at 37° C. in 5% CO 2 incubator showed elevation in CD19, HLADR, NK CD3-/CD56+ and CD38 populations as shown in FIG. 1. CD19 surface marker index showed an elevation of 90% as compared to control, while HLADR, NKCD3-/CD56+ and CD38 population showed elevations of 44, 38 and 5% respectively. There was not much alteration in the CD3 population.

N. sativa extract, rather than the increase in immune competent cell number, helped free tumor antigen binding sites on B cells, thereby elevating the CD19 and associated cell population. Data from flow cytometric analysis indicates elevation in CD19, HLADR, NK CD3-/CD56+ and CD38 population. There was not much alteration in CD3, CD37 and CD33 surface marker index. This data clearly indicates proliferation in immune competent cells, mainly the humoral response against tumor antigens. Thus, the extract, rather than the increase in immune competent cell number, helps free tumor antigen binding sites on B cells, thereby elevating the CD19 and associated cell population.

Connective tissue `L` cells at a concentration of 5×10 5 upon incubation with N. sativa plant extract and patient serum/white blood cells showed elevation in cell number. `L` cells when incubated with media alone was 2.0×10 4 , which increased to 4.7×10 4 and to 7.4×10 4 upon incubation with cancer patient serum and plant extract and cancer patient white blood cells and plant extract, respectively. This indicated an elevation of 135 and 270% respectively as shown in Table 4 (supra.) On the other hand, interferon and interleukin-2 gave marginal elevations of 35 and 15% only upon incubation with 5×10 5 `L` cells in an ideally same environment as that of N. sativa plant extract.

Immunomodulatory evaluation indicates enhanced proliferation of the connective tissue `L` cells in presence of N. sativa extract than in its absence, thereby indicating positive immunomodulatory effect of the extract. Similar results were also obtained with patient white blood cells.

Data indicates presence of an interferon inhibitor factor (IIF) in cancer patient serum due to which there is no proliferation of the `L` cells when they were incubated with patient serum alone. IIF and lymphokine inhibitor factor (LIF) in patient serum get suppressed post treatment with N. sativa plant extract, thereby exhibiting enhanced proliferation of `L` cells. The IIF cannot be identified with antibodies against interferon.

IIF is a factor which does not allow the production of autologous (self) interferon in the human body. When the inducer initiates the production of interferon, the human body produces another protein which neutralizes the possibility for production of interferon. LIF includes all factors that suppress cytokine activity, including interferons.

The increased stimulation of connective cells by the reduction of IIF and LIF allows the human body to produce its own interferon, which then interferes with controlling connective tissue cell production. For this reason, N. sativa has potential use in connective tissue diseases such as rheumatoid arthritis, lupus and autoimmune diseases.

Experiment 3

Cytopathic Effects of Vesicular Stomatitis Virus

Cell Line: The human amnion or “WISH” cells were obtained from the American Type Cell Culture facility (ATCC) and grown in Basal Eagle Medium (BEM) (GIBCO) with 15% fetal bovine serum.

Virus: Vesicular stomatitis virus (VSV) was obtained from the ATCC. The VSV stock solution was diluted 1000× with BEM containing 2% fetal bovine serum (FBS).

Assay: The assay was conducted as described above in Procedure 4. For determining the amount of protection conferred to the “WISH” cells by N. sativa plant extract, complete viral cytopathic effect (CPE) was calculated by inoculating 8-10 ml per flask of the 1:1000 VSV into each WISH cell flask (containing 3.5×10 5 cells/ml) such that it covered the entire cell layer. The flasks were incubated for 1 hour at 37° C. in a 5% CO 2 incubator. Fifteen ml of the BMEM with 2% FBS were added to each flask and incubated at 37° C. in a 5% CO 2 incubator for 1-3 days or until cell layer showed complete viral cytopathic effect (CPE). N. sativa plant extract was serially diluted in a 96-well polystyrene plate. To 40 μl of the extract was added 100 μl of the 3.5×10 5 cells/ml “WISH” cell suspension and the plates were incubated for approximately 18-24 hours at 37° C. at 5% CO 2 . In the control wells, no extract was added. Next day (after 18-24 hours) the plates were observed under Nikon TMS microscope for confluency. Fifty μl VSV were added (in a concentration to yield 100% CPE), and Incubated 24-48 hours at 37° C. with 5% CO 2 .

The next day, the plates were observed under a Nikon TMS microscope for 100% CPE in the viral control wells. Once satisfied, the plates were dumped and blotted. One hundred μl of 15% neutral red dye were added to all wells. The wells were incubated at 37° C. in 5% CO 2 incubator for 45 minutes. The plates were dumped, blotted and rinsed with 200 μl PBS at pH 6.85. The plates were again dumped and blotted. The cells were eluted by adding 100 μl of the eluting solution to each well. The plates were read on Bio-Rad Model 3550 microplate reader.

The concentration of vesicular stomatitis virus (VSV) producing 100% cytopathic effect (CPE) of human amniotic “WISH” cells was first determined, which was 1×10 5 plaque forming units. Optimum protection to WISH cells conferred by N. sativa extract was then calculated by serially diluting N. sativa extract and adding in between WISH cells and VSV.

Results: The results depicted in FIG. 2 indicate protection of “WISH” cells in the order of 25 and 65% upon incubation with 1:10 and 1:100 diluted N. sativa plant extract. There was no noticeable cytopathic effect when N. sativa was added at a dilution of 1:1000. Approximate active compound concentrations were calculated according to materials and methods. Serum interferon levels were measured after plant extract administration according a modified procedure of Finter (1969).

Protection of Human Amniotic “WISH” cells from cytopathic effects of vesicular stomatitis virus (VSV) was observed upon administration of 1:1000 diluted N. sativa plant extract. This had an active compound concentration of 88 ng. At a lower dilution, there was some effect. Theoretically, a patient weighing 70 kg has about 7×10 13 cells in its body and N. sativa will be useful in the dosage of 20-40 g to protect against viral attack in virus endemic areas. Upon administration of the extract, the serum interferon level is found to increase and hence N. sativa has interferon-like antiviral activity. The extract possibly blocks all receptor sites on “WISH” cells which are essential for attachment of the virus to cell membrane.

Experiment 4

Pharmacosensitivity Assay

The tumor specimens can be of 2 types: solid tumor and liquid tumor.

Solid tumor: 2 grams of tumor specimen were excised, cut into pea size portions and gently homogenized in a Potter-Elvehjam homogenizer with 10% FBS, centrifuged at 1600 rpm for 20 minutes in a Mistral 3000i refrigerated centrifuge at 4° C. Cells were finally suspended in media RPMI 1640 with 10% FBS into a fine suspension.

Liquid tumor: The specimen was collected from the ascitic fluid of cancer patients. The ascitic fluid was gently layered on a histopaque using a 1:1 ratio of the histopaque to specimen, and centrifuged at 1600 rpm for 20 minutes in a Mistral 3000i refrigerated centrifuge at 4° C. Cells were finally suspended in RPMI with 10% FBS.

Assay: The assay was performed according to the modified processes of Von Hoff, et al. (1981) and Salmon, et al. (1978), which are incorporated herein by reference, as described above in Procedure 5. Tumoricidal activity of N. sativa was checked on a double agar layer. The lower layer of warm 2.5% Bacto-agar working solution was poured into 35 mm grid petri dishes. The plates were then allowed to sit undisturbed on a flat surface until the agar solidified. To 2.1 ml of the upper layer media containing 150 ml FBS, 150 ml 2× G.G. fortified solution and 150 ml 1× G.G. fortified solution, 0.3 ml of the tumor cells and 0.6 ml of the 1.5% agar were added.

The upper layer was carefully layered on top of the lower layer in the 35 mm grid petri dish. Tumor specimens grown without the extract and with `Abrin` were used as controls. Tumor cell growth in the presence of the plant extract was monitored 7, 14 and 21 days post incubation at 37° C. and 5% CO 2 , at which time the cells were counted under a Reichert-Jung biostar inverted microscope. Cells from tumor specimens [8.2×10 4 ] were grown with media/Abrin plant extract on a double agar layer and incubated for 7, 14 and 21 days at 37° C. in a humid 5% CO 2 incubator. The results are shown on Table 5 as follows:
TABLE 5
______________________________________
INCU- BATION INCUBATION TIME MIX- % % % TURE 7 days Inh 14 days Inh 21 days Inh
______________________________________

TUMOR 8.2 × 10 4
0 10.0 × 10 4
0 10.5 × 10 4
0
CELL &
MEDIA
TUMOR 8.1 × 10 4
1.2 9.8 × 10 4
2.0 10.3 × 10 4
1.9
CELL &
ABRIN
TUMOR 5.3 × 10 4
35.0 5.4 × 10 4
46.0 5.5 × 10 4
48.0
CELL &
EX-
TRACT
______________________________________

The SD of the data was <10%. Percentage of inhibition was calculated as described in Materials & Methods.

The results are analyzed on the basis of pharmacosensitivity assay in which tumor cell growth was monitored. Seven, 14 and 21 days post incubation with plant extract indicated tumoricidal activity. Hence, N. sativa extract possessed a multifaceted toxic-free cure for cancer.

Results: Tumor specimens (2 grams) either from solid tumor masses or malignant ascites were mechanically homogenized into a suspension containing 8.2×10 4 cells. Incubation of tumor cells at 37° C. in a humid 5% CO 2 incubator for 7, 14 and 21 days with N. sativa plant extract indicated a percent inhibition of 35, 46 and 48, respectively. Incubation with Abrin in an ideally similar condition did not exhibit any noticeable inhibition.

N. sativa promotes anti-tumor activity. Data from pharmacosensitivity screening indicates anti-tumor activity of N. sativa plant extract, as cell growth in culture was inhibited anywhere between 25-90%. In vitro tumor study report, using rapid screen for early pharmacosensitivity screening, in which cells were incubated with N. sativa plant extract for 2 hours, gave similar results. Hence, the extract indicates anti-tumor function mainly against melanoma and colon cancer types. N. sativa plant extract destroys tumor cells and leaves normal cells alone, possibly because of its ability to bind to cell surface asialofeutin (lectin) in diseased cells, which causes aggregation and clumping of tumor cells. It also blocks enzymes and inappropriate gene products involved in nucleic acid synthesis and metabolism.

It is understood that the invention is not confined to the particular construction and arrangement herein described, but embraces such modified forms thereof as come within the scope of the claims following the bibliographic citations.

BIBLIOGRAPHY

Agarwal, R., Kharya, M. D., and Shrivastava, R., 1979, “Antimicrobial anthelmintic activities of the essential oil of Nigella sativa Linn,” Indian J. Exp. Biol. 17, 1264.

Akhtar, M. S.; Riffat, S., 1991, “Field Trial of Saussurea Lappa Roots Against Nematodes and Nigella Sativa Seeds Against Cestodes in Children,” JPMA J Pak Med Assoc 41(8)185-7.

al-Awadi, F. M., Khattar, M. A. and Gumaa, K. A., 1985, “On the Mechanism of the Hypoglycemic Effect of a Plant Extract,” Diabetologia 28, 432-434.

al-Awadi, F.; Fatania, H.; Shamte, U., 1991, “The Effect of a Plant’s Mixture Extract on Liver Gluconeogenesis in Streptozotocin Induced Diabetic Rats,” Diabetes Res (Scotland) 18(4):163-8.

Aruna, K.; Sivaramakrishnan, V. M., 1990, “Plant Products as Protective Agents Against Cancer,” Indian J Exp Biol 28(11):1008-11.

Aruna, K.; Sivaramakrishnan, V. M., 1992, “Anticarcinogenic Effects of Some Indian Plant Products,” Food Chem Toxicol (England) 30(11)953-6.

Bitterman, W. A.; Farhadian, H.; Abu Samra, C.; Lerner, D.; Amoun, H.; Krapf, D;. Makov, U. E., 1991, “Environmental and Nutritional Factors Significantly Associated with Cancer of the Urinary Tract among Different Ethnic Groups,” Urol Clin North Am 18(3)501-8.

Chopra, R. N., Chopra, I. C., Handa, K. L., and Kapur, L. D., 1982, Indigenous Drugs of India, Academic Publishers; Calcutta, India.

Datta, A. K., Biswas, A. K. and Ghosh, P. D., 1983, “Chromosomal variations in callus tissues of two species of Nigella sativa, L.,” The nucleus 26(3) 173-177.

Elkadi, A ; Kandil, O., 1987, “The Black Seed Nigella sativa and Immunity Its Effects on Human Cell Subsets,” Fed Proc 45(4)1222.

Finter, N. B., 1969, “Dye Uptake Methods for Assessing Viral Cytopathogenicity and Their Application to Interferon Assays, ” J. Gen. Virol. 5, 419-427.

Karen, D. F., 1989, “Flow Cytometry in Clinical Diagnosis,” American Society of Clinical Pathology (press).

Kirtikar, K. R. and Basu, B. D., 1982, Indian Medicinal Plants, Vol. I, Bishen Singh and Mahendra Pal Singh, eds., Dehra Dun, India.

Kumar, B. H. and Thakur, S. S., 1989, “Effect of Certain Non-edible Seed Oils on Growth Regulation in Disdercus Similis (F), J. Anim. Morphol. Physiol. 36(2) pp. 209-218.

Medenica, R., Alonso, K., Huschart, T. and Tyler, K., 1990, “Tumor Tissue Culture for Determining Efficient Drug for Intra-Arterial, Intra-Hepatic Chemotherapy and Interferon of Colon Carcinoma Liver Metastasis,” Abstract presented at Conference on Combining BRM with Cytotoxic in the Treatment of Cancer.

Merkel, D. E., Dressier, L. G. and McGuire, W. L., 1987, “Flow Cytometry Cellular DNA Contents and Prognosis in Human Malignancy,” J. of Clinical Oncology, 5, 1690-1703.

Metcalf, D., 1984, Clonal Culture of Hematopoietic Cells, Elsevier/North American Biomedical Press.

Metcalf, D., 1985, “The Granulocyte Macrophage Colony Stimulating Factors,” Science 229, 16-22.

Nadkarni, K. M., 1976, “Crocus sativus, Nigella sativa,” Indian Materia Medica, K. M. Nadkarni (ed) Bombay, India; Popular Prakashan, Vol 1, pg. 386-411.

Nair, S. C.; Salomi, M. J.; Panikkar, B.; Pannikar, K. R., 1991, “Modulatory Effects of Crocus sativus and Nigella sativa Extracts on Cisplatin-Induced Toxicity in Mice,” J Ethnopharmocol 31(1): 75-83.

Salmon, S. E., Hamburger, A. W., Soehnlein, B., 1978, “Quantitation of Differential Sensitivity of Human Tumor Stem Cells to Anticancer Drugs, , ” N. Eng. J. Med. 298, 1321-1327.

Salomi, N. J.; Nair, S. C.; Jayawardhanan, K. K.; Varghese, C. D.; Panikkar, K. R., 1992, “Anititumour Principles from Nigella sativa Seeds,” Cancer Lett 63(1):41-6.

Salomi, M. J.; Nair, S. C.; Panikkar, K. R., 1991, “Inhibitory Effects of Nigella sativa and Saffron (Crocus Sativus) on Chemical Carcinogenesis in Mice,” Nutr Cancer 16(1):67-72.

Sayed, M. D., “Traditional Medicine in Health Care,” 1980, J Ethnopharmocol 2(1):19-22.

Shayeb, N. A. and Mabrouk, S. S., 1984, “Utilization of Some Edible and Medicinal Plants to Inhibit Aflatoxin Formation,” Nutrition Reports International 29(2).

Siddiqui, M. B., Alam, M. M., Husain, W. and Sharma, G. K., 1988, “Ethno-medical Study of Plants used for Terminating Pregnancy,” Fitoterapia V. LIX, no. 3, 250.

Salmon, S. E.; Hamburger, A. W.; Soehnlein, B.; et al., 1978, “Quantitation of differential sensitivity of human tumor stem cells to anticancer drugs,” N Engl J Med 298:1321-1327.

Srivastava, K. C., 1989, “Extracts from Two Frequently Consumed Spices–Cumin (Cuminum cyminum) and Turmeric (Curcuma Longa)–Inhibit Platelet Aggregation and Alter Eicosanoid Biosynthesis in Human Blood Platelets,” Prostaglandins Leukot Essent Fatty Acids 37(1)57-64.

Tennekoon, K. H.; Jeevathayaparan, S.; Kurukulasooriya, A. P.; Karunayake, E. H., 1991, “Possible Hepatotoxicity of Nigella sativa Seeds and Dregea Volubilis Leaves,” J Ethnopharmocol 31(3):283-9.

Vihan, V. S. and Panwar, H. S., 1987, “Galactopoietic Effect of Nigella sativa (H-Kalonji) in Clinical Cases of Agalactia in Goats, ” Indian Vet. J. 64, 347-349.

Von Hoff, D. D., Cowan, J., Harris, J. and Reisdorf, G., 1981, “Human Tumor Cloning: Feasibility and Clinical Correlations,” Cancer Chemother. Pharmacol. 6, 265-271.

WHO Nilai Vaksinasi Massal Anti H5N1 Tak Diperlukan

22/12/2007 00:39 WIB

22/12/2007 00:39 WIB

WHO Nilai Vaksinasi Massal Anti H5N1 Tak Diperlukan
Indra Subagja – detikcom

Jenewa – Badan Kesehatan Dunia PBB (WHO) menyatakan pemberian vaksin secara massal dalam kampanye melawan flu burung tidak diperlukan. Ini karena belum terbuktinya wabah flu burung menjadi pandemic.”Belum ada bukti yang menunjukan kalau kita harus melakukan vaksinasi terhadap seluruh populasi, karena belum diketahui apa sebenarnya yang menyebabkan pandemic,” kata Asisten Direktur Jenderal WHO David Heyman seperti dikutip dari AFP, Jumat (21/12/2007).Virus H5N1, yang telah menyebabkan 209 kematian sejak 2003 lalu, adalah bukan satu-satunya jenis virus yang bisa menyebarkan pandemic. Tetapi ada jenis lainnya seperti H5, H7, atau H9 yang hampir sejenis.Heyman menjelaskan banyak negara yang menyebarkan kampanye vaksinasi masal sebagai upaya perlawanan dan perlindungan dari serangan virus flu burung. Namun hal itu justru sebaliknya, seperti contoh ketika terjadi vaksinasi wabah flu di AS pada 1976 lalu, justru memberikan efek lain.”Pemberian vaksinasi justru akan memberikan kekebalan yang lebih rendah melawan virus dan justru akan memudahkan terjadi pandemic, ini sebagai efek dari pemberian vaksin itu,” tandas Heyman.( ndr )WHO Nilai Vaksinasi Massal Anti H5N1 Tak Diperlukan
Indra Subagja – detikcom

Jenewa – Badan Kesehatan Dunia PBB (WHO) menyatakan pemberian vaksin secara massal dalam kampanye melawan flu burung tidak diperlukan. Ini karena belum terbuktinya wabah flu burung menjadi pandemic.”Belum ada bukti yang menunjukan kalau kita harus melakukan vaksinasi terhadap seluruh populasi, karena belum diketahui apa sebenarnya yang menyebabkan pandemic,” kata Asisten Direktur Jenderal WHO David Heyman seperti dikutip dari AFP, Jumat (21/12/2007).Virus H5N1, yang telah menyebabkan 209 kematian sejak 2003 lalu, adalah bukan satu-satunya jenis virus yang bisa menyebarkan pandemic. Tetapi ada jenis lainnya seperti H5, H7, atau H9 yang hampir sejenis.Heyman menjelaskan banyak negara yang menyebarkan kampanye vaksinasi masal sebagai upaya perlawanan dan perlindungan dari serangan virus flu burung. Namun hal itu justru sebaliknya, seperti contoh ketika terjadi vaksinasi wabah flu di AS pada 1976 lalu, justru memberikan efek lain.”Pemberian vaksinasi justru akan memberikan kekebalan yang lebih rendah melawan virus dan justru akan memudahkan terjadi pandemic, ini sebagai efek dari pemberian vaksin itu,” tandas Heyman.( ndr )

Imunisasi polio

http://www.bbc.co.uk/indonesian/forum/story/2005/08/050826_polioungkapan.shtmlImunisasi polio



Pemerintah bekerjasama dengan UNICEF dan WHO tanggal 30 Agustus mengadakan pekan imunisasi nasional polio untuk 24 juta anak di seluruh Indonesia.

Menurut data UNICEF penyebaran kasus polio di Indonesia paling tinggi di dunia dan sangat rentan sebagai tempat penyebaran polio padahal tahun 1995, Indonesia telah dinyatakan bebas polio.

Dalam program imunisasi di beberapa daerah seperti Jakarta dan Banten bulan lalu, jumlah anak yang divaksin menurun sekitar satu juta orang dibandingkan dalam vaksinasi putaran sebelumnya, setelah beredar berbagai rumor miring, misalnya vaksin polio tidak halal dan vaksin bisa menyebabkan kematin.

Pemerintah berulangkali menegaskan rumor tersebut tidak benar dan sejumlah ulama sekarang menyatakan vaksin polio halal.

Apa yang seharusnya dilakukan orang tua dalam pekan imunisasi nasional polio ini?

Bagaimana pendapat anda tentang imunisasi polio dan kekhawatiran sebagian orang tentang keamanan vaksin?

Selain imunisasi, langkah-langkah apa yang perlu dilakukan masyarakat sendiri untuk mencegah polio?

Ramaikan Ungkapan Pendapat BBC London dengan mengirimkan komentar anda melalui situs BBCindonesia dot com lalu klik ungkapan pendapat dan isi kolom yang disediakan, atau melalui email indonesian@bbc.co.uk. Tolong sertakan nomer telpon anda kalau ada.

Anda bisa pula menelpon kami di nomer bebas pulsa 0800 140 1228 yang kami buka setiap Selasa dan Jumat malam pukul 18.30 dan 20.30 Waktu Indonesia Barat.

Menkes Kesal OKI Tidak Menerima Vaksin Berlabel Halal

15/06/07 16:26

http://www.antara.co.id/arc/2007/6/15/menkes-kesal-oki-tidak-menerima-vaksin-berlabel-halal/

Menkes Kesal OKI Tidak Menerima Vaksin Berlabel Halal

Kuala Lumpur (ANTARA News) – Menteri Kesehatan RI, DR dr Siti Fadillah Supari, menyatakan bahwa sangat kecewa dengan hasil pertemuan para menteri kesehatan negara anggota Organisasi Konperensi Islam (OKI), karena tidak menerima usulan Indonesia agar ada label halal dalam peredaran vaksin di negara anggotanya.

“Ironis, para menteri kesehatan negara-negara Islam bersidang, tetapi menolak usulan Indonesia agar negara-negara OKI perlu memberikan label halal dalam vaksin yang beredar di lingkungan OKI. Lalu apa gunanya ada pertemuan para menteri kesehatan OKI?,” kata Siti Fadilah, di tengah-tengah pertemuan menteri kesehatan OKI, di Kuala Lumpur, Jumat.

Menurut dia, Indonesia telah berhasil membuat vaksin halal, dan oleh karena itu dibutuhkan dukungan negara-negara Islam untuk membelinya, tetapi malah ditolak.

“Jika mengklaim sebagai negara Islam, janganlah sembarangan membeli vaksin. Belilah vaksin berlabel halal. Negara Islam belilah vaksin halal yang diproduksi negara Islam, tetapi malah ditolak, katanya nanti malah membuat isu menyeramkan,” katanya.

Menkes juga kecewa dengan pertemuan para menteri kesehatan OKI yang tidak mengutuk perang di Irak, Afghanistan, dan Palestina, di mana upaya meningkatkan kesehatan masyarakat terhambat akibat perang.

“Hari ini anak-anak diberi vaksin folio besoknya sudah meninggal kena bom. Belum dikasih vaksin, anak-anak sudah meninggal kena bom. Bagaimana negara-negara Islam berupaya meningkatkan kesehatan umat Islam tetapi tidak membahas masalah perang yang dihadapi negara-negara Islam saat ini,” katanya.

Ia juga mengemukakan bahwa masalah kesehatan yang minim pada negara Islam bukan hanya masalah ekonomi, tetapi juga politik, karena banyak anak-anak meninggal dunia karena kurang gizi akibat peperangan, tekanan politik internasional, dan politik, misalnya di negara-negara Islam Afrika, Irak, dan Iran yang akan diancam embargo ekonomi karena ingin mengembangkan nuklir untuk kepentingan umat.

“Harus diakui angka kematian bayi, angka kematian ibu di negara-negara muslim lebih tinggi dibandingkan negara-negara non-muslim, tetapi mereka meninggal bukan karena kesehatan, bukan hanya kekurangan gizi, tetapi banyak juga yang meninggal karena terkena bom,” ujarnya.

Menurut dia, hasil pertemuan para Menkes OKI yang pertama ini dan diselenggarakan Kuala Lumpur Malaysia kurang menggigit.

RI Kecewa Tak Ditanggapi WHO

http://www.jawapos.com/index.php?act=detail_c&id=311806

Jumat, 09 Nov 2007,
RI Kecewa Tak Ditanggapi WHO

Kasus 58 Varian Virus Flu Burung
JAKARTA – Departemen Kesehatan kembali kecewa terhadap sikap Badan Kesehatan Dunia (WHO) yang tidak mengembalikan 58 varian virus H5N1 milik Indonesia. Alasan WHO, setiap virus yang sudah dikirim tidak bisa dikembalikan lagi ke negara yang bersangkutan.

“Jadi, negara pengirim seakan tidak memiliki hak atas virus tersebut,” ujar Menkes Siti Fadilah Supari usai jumpa pers Hari Kesehatan Nasional (HKN) ke-43 bertema Rakyat Sehat, Negara Kuat di gedung Depkes, Jl HR Rasuna Said, Kuningan, kemarin.

Menurut Siti, sejak Agustus lalu Depkes melayangkan surat kepada WHO untuk meminta kembali virus flu burung tersebut. Namun, tidak ada satu pun balasan dari WHO. “Kami mengirimkan 58 seed virus ke WHO dan meminta dikirim kembali ke Indonesia, tapi tidak pernah mendapat jawaban. Ini merampas, bukan menyandera lagi,” ujar Siti.

Virus yang dikirimkan Indonesia (dan beberapa negara berkembang) ke WHO, saat ini dengan mudah berpindah tangan ke institusi riset di beberapa negara adidaya. Mereka mengambil virus dengan gratis dan diteliti untuk pembuatan vaksin. Produk itu lalu dijual ke negara-negara pemilik virus dengan harga mahal.

Siti mengingatkan pengalaman Indonesia di masa lampau. Kata dia, WHO pernah meminta seluruh virus cacar Indonesia yang saat itu memiliki varian terganas yang ditemukan saat penjajahan Belanda.

“Saat itu tiba-tiba WHO mengumumkan seluruh dunia tidak boleh mempunyai virus cacar. Sampai-sampai laboratorium Biofarma (BUMN farmasi) yang punya virus cacar dirusak dan tempat virus itu dihancurkan,” kisah Siti.

Anehnya, secara mengejutkan, pada 4 hingga 5 tahun kemudian, Amerika Serikat tiba-tiba berhasil menemukan vaksin virus cacar dan meminta dunia membeli vaksin darinya. “Kalau tidak membeli, saat itu (ditakuti) ada senjata biologis virus cacar sebagai ancaman. Akibatnya, kita terseok-seok karena harga vaksinasinya mahal,” katanya.

Belajar dari pengalaman tersebut, Siti tidak mau hal itu dialami Indonesia lagi. Siti menilai mekanisme sharing sampel tersebut tidak adil dan harus diperbaiki. Menurut dia, mekanisme pengiriman virus itu seharusnya diimbangi timbal balik penyerahan vaksin kepada negara pemilik virus.

“Kalau Indonesia memiliki, Indonesia bisa meneliti virus itu untuk pengembangan vaksin, alat diagnostik, maupun antibodi,” ujarnya.

Menurut Siti, mekanisme seperti yang dilakukan WHO ini tidak adil. Virus itu milik bangsa. Tidak seorang pun yang memaksa harus diserahkan kalau memang menyusahkan negara kita. “Apa pun protokolnya, kita adalah negara yang berdaulat,” lanjutnya. (bay)

Diimunisasi, Ratusan Sakit

http://suaramerdeka.com/harian/0707/03/inta.htm

LINTAS JAGAT
Poros Persatuan Anti-AS

ASSALOUYEH – Presiden Iran dan Venezuela Senin kemarin memperkuat “poros persatuan” di antara kedua negara itu untuk melawan Amerika Serikat. Persatuan itu diwujudkan dengan kesepakatan pembangunan bersama pabrik petrokimia.

Presiden Hugo Chavez dan Presiden Mahmoud Ahmadinejad juga menandatangani beberapa kesepakatan lain untuk memperluas kerja sama ekonomi, mulai dari pembangunan pabrik makanan di Venezuela hingga pendirian perusahaan minyak.

“Kedua negara akan bersatu untuk mengalahkan imperalisme Amerika,” kata Chavez saat jumpa pers di sela-sela kunjungan resmi ke Republik Islam Iran.”Ketika saya tiba di Iran, Washington jengkel,” kata dia.

Kedua presiden sebelumnya menghadiri upacara peletakan batu pertama pembangunan pabrik metanol berkapasitas produksi 1,65 ton setahun di pantai Teluk, Iran.

“Iran dan Venezuela adalah poros persatuan,” demikian tertulis pada poster-poster resmi di dekat lokasi pabrik di Kota Assalouyeh. Pada poster itu, diperlihatkan kedua pemimpin sedang berjabat tangan sambil berangkulan.

Ahmadinejad menyebut peristiwa itu sebagai langkah maju mempererat persaudaraan dua negara revolusioner itu.(rtr-gn-25)

Diimunisasi, Ratusan Sakit

ISLAMABAD – Lebih dari 500 orang, termasuk anak-anak, dirawat di klinik-klinik dan rumah sakit setelah menjalani program imunisasi di Provinsi Perbatasan Baratlaut Pakistan.

Mereka jatuh sakit setelah mendapat vaksin anti-TBC dan kolera. Imunisasi itu diberikan para pegawai pemerintah kepada penduduk yang tinggal di daerah Regi di Peshawar, ibu kota provinsi tersebut.

“Empat anak saya tidak sadarkan diri tak lama setelah pemberian vaksin itu,” kata Mohammad Arshad kepada surat kabar setempat.

Aparat setempat menghentikan sementara pekerjaan sambilan pegawai kesehatan yang melakukan imunisasi terhadap penduduk di Regi dan membentuk sebuah tim untuk menyelidiki peristiwa itu.

Program vaksinasi itu, yang dilakukan setelah hujan dan banjir di provinsi yang berbatasan dengan Afghanistan itu, juga dihentikan sampai penyelidikan tersebut selesai.(ant-25)

Rushdie Ceraikan Istri

NEW YORK – Penulis Inggris Salman Rushdie dan istrinya Padma Lakshmi akan bercerai. Juru bicara Lakshmi mengemukakan hal itu Senin kemarin. Kabar perceraian itu hanya berselang dua minggu setelah Rushdie menerima gelar bangsawan yang kontroversial dari Kerajaan Inggris.

Rushdie (60) mendapat kecaman luas karena novelnya Ayat-ayat Setan. Dia menikahi Lakshmi, mantan model kelahiran 1970 di India, pada tahun 2004. Lakshmi adalah istri keempat dan pasangan itu tidak dikaruniai anak.

“Salman Rushdie akan menceraikan istrinya karena Lakshmi berniat mengakhiri pernikahan itu,” kata juru bicara Jin Auh.(rtr-25)