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Huyết thanh bí ẩn chữa Ebola
06 Aug, 2014
Huyết thanh thử nghiệm 'bí ẩn' đã được dùng cho hai bệnh nhân người Mỹ đầu tiên - bác sĩ Kent Brantly và người đồng sự, Nancy Writebol, ngày càng có nhiều báo cáo về sự hồi phục 'kỳ diệu' của hai người này, trước đây chưa hề được thử nghiệm trên người, mà mới chỉ có triển vọng ở những thí nghiệm nhỏ với khỉ.
Các nhân viên y tế nói rằng, thuốc chữa Ebola không khó, nhưng các công ty dược phẩm không thấy bất kì lợi ích kinh tế nào để đầu tư vì số nạn nhân "ít ỏi" của các con virus này là những người dân nghèo châu Phi.
Rõ ràng, các công ty dược phẩm sẽ không đầu tư hàng triệu USD để một loại thuốc vượt qua được các thử nghiệm của Cục quản lý Thực phẩm và Dược phẩm Mỹ (FDA) cho một bệnh chỉ khiến vài nghìn người tử vong kể từ khi được phát hiện từ năm 1976 đến nay.
Tuy nhiên, vẫn có người thấy lý luận đơn thuần kinh tế này không chấp nhận được. Giáo sư John Ashton, gọi đây là "phá sản đạo đức" của các công ty dược phẩm vì lợi nhuận. (Tuy nhiên, lập luận kinh tế này cũng áp dụng với các công ty xe hơi, các công ty không thể cho không xe ôtô cho những người nghèo được, và có ai gọi họ là "phá sản đạo đức" đâu?)
Có ít nhất 2 giải pháp cho vấn đề này đó là trợ cấp (bảo đảm lợi nhuận đầu tư của các công ty dược phẩm bằng tiền thuế của người dân), hoặc trao giải thưởng, hoặc gỡ bỏ các quy định phức tạp của FDA...
Bài trước: Tự tin là chính tôi
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The Telegraph reports:
The two American doctors who have caught Ebola have been treated with a new “secret serum” which could potentially save their lives.
…A source close to the Atlanta hospital, where Dr Brantly is being treated, told CNN: “Within an hour of receiving the medication, Brantly’s condition was nearly reversed. His breathing improved; the rash over his trunk faded away.”
One of his doctors reportedly described the events as “miraculous.”
…Dr Writebol was also administrated with the drug, which was transported to Liberia in a special sub-zero container. She showed a less remarkable recovery, but is hoped to travel to the US on Tuesday to continue her treatment.
According to CNN, the drug was developed by the biotech firm Mapp Biopharmaceutical, based in California. The patients were told that this treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.
…health workers said drugs that could fight Ebola are not particularly complicated but pharmaceutical firms see no economic reason to invest in making them because the virus’ few victims are poor Africans.
Of course, pharmaceutical firms are not going to invest millions in getting a drug through FDA trials for a disease that has only killed a few thousand people since being discovered in 1976. Nevertheless, some people find this simple logic difficult to accept.
Prof John Ashton, Britain’s leading public health doctor, termed the “moral bankruptcy” of profit-driven drugs developers.
The logic of profit-driven drug developers is no different than the logic of profit driving automobile manufactures. It isn’t profitable to make cars for people who can’t afford them but the auto firms are rarely called morally bankrupt for not giving cars away to the poor. Moreover, it’s not at all obvious why the burden of producing unprofitable drugs should fall on the drug manufacturers. To the extent that there is an ethical case for developing drugs for the poor it’s a burden that falls on all of us.
As Eric Crampton notes there are at least two possible solutions. Either ensure at taxpayer expense a return on investment by subsidizing, offering prizes (as I suggested in Launching) or publicly investing in orphan drugs or
…ease up the FDA trials for drugs in this kind of category. Does it really make sense to mandate placebo trials for drugs hitting diseases with 60% fatality rates? We are condemning people to a very high risk of death for the sake of ensuring that there aren’t drug side effects and that the drugs are more effective than placebos (pretty easy to tell quickly where the fatality rate is otherwise 60%!).
Tags: health
Everyone: *Panic!*
Scientists: Freak out about climate change.
Everyone: LOL! Pass me some coal.
Via @emmkaff on Twitter.
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Yo is a smartphone app. MelaFind is a medical device. Yo sends one meaningless message: “Yo!” MelaFind tells you: “biopsy this and don’t biopsy that.” MelaFind saves lives. Yo does not. Guess which firm found it easier to put their product in consumers hands? Oy.
In “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind. When Dr. Gulfo joined the firm as president and CEO in 2004, the company’s brilliant team of scientists had spent many years and tens of millions of dollars to develop MelaFind, a “camera with a brain”—optical technology that would scan potential melanomas in multiple spectra and then, using sophisticated algorithms and large datasets, diagnose which were most likely to be cancerous.
MELA Sciences conducts an extensive clinical trial according to a protocol agreed on by the FDA and all looks good. After the clinical trial is completed, however, the FDA backs away from the protocol and comes out against MelaFind.
…The title of Dr. Gulfo’s book is “Innovation Breakdown” but “Innovator’s Breakdown” might have been more apt. The letter sent the author into survival mode. He battled the FDA, calmed investors, and defended against the lawsuit all while trying to keep the company afloat. Under stress, Dr. Gulfo’s health began to decline: He lost 29 pounds, his hair began to fall out, and the pain in his gut became so intense he needed an endoscopy. When his wife begged him to quit, he refused. They turned into roommates. “We were nothing more than cordial. I basically shut my wife out of my life,” he writes.
…The climax to this medical thriller comes when, in “the greatest 15 minutes of [his] life,” Dr. Gulfo delivers an impassioned speech, à la “Twelve Angry Men,” to the FDA’s advisory committee. The committee voted for approval, 8 to 7, and, perhaps with the congressional hearing in mind, the FDA approved MelaFind in September 2011.
It was a major triumph for the company, but Dr. Gulfo was beat. He retired from the company in June 2013—just in time to save his marriage.
Yet remarkably, given his experience, Mr. Gulfo writes that he still believes in a strong FDA. He argues in the book that better “leadership” and a few tweaks to existing rules can fix the problem. He’s wrong.
Compare MelaFind’s experience in the U.S. with its reception in Europe: MelaFind was submitted for marketing approval in Europe in May 2011. It was approved just five months later. One key reason for Europe’s efficient approval process is that European governments don’t review medical devices directly. Instead they certify independent “notified bodies” that specialize and compete to review new products. The European system works more quickly than the U.S. system, and there is no evidence that it results in reduced patient safety. Rather than tweak the current system, why doesn’t the U.S. just adopt the European model and call it a day? Our health and our economy would be better off for it.
Google’s Sergey Brin recently said that he didn’t want to be a health entrepreneur because “It’s just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.” Mr. Brin won’t find anything in Dr. Gulfo’s book to persuade him otherwise. Until we get our regulatory system in order, expect a lot more Yo’s and not enough life-saving innovations.
[img]https://i.chzbgr.com/maxW500/8284627200/h31638981/[/img]
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Ebola plush toys have been selling so fast in response to this year’s outbreak that a Connecticut manufacturer, Giantmicrobes Inc., can’t keep them in stock.
The company, which was founded a decade ago, makes stuffed toys based on the appearance of microbes like Ebola, Chicken pox, bed bugs, and even non-harmful microscopic organisms things like brain and red blood cells.
The items are meant to be educational tools for young children, Laura Sullivan, vice president of operations, told CBS News.