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Goozner on the FDA and the Declaration of Helsinki

Posted by Osagie Obasogie on May 15th, 2008

Over at, Merrill Goozner describes what may be a significant yet silent step backwards in protecting human research subjects: an FDA decision to no longer adhere to aspects of the Declaration of Helsinki that require clinical trial participants in control groups to receive best available care.

Goozner describes the FDA’s new rule as only requiring drug companies to follow good clinical practice, meaning that control group subjects are only entitled to the standard care they would otherwise receive in their locale. Goozner argues that this can have a significant impact on the growing number of clinical trials outsourced to the developing world. He notes:

What will this mean for the concept of "informed consent" in a poor country? Imagine for a moment that you live on $2 a day in, say, Zimbabwe, and have high blood pressure. Since the disease isn't life-threatening, you skip buying the available anti-hypertensives being sold in the village pharmacy because you can't afford them and none are on the national formulary. Hence, there is no local standard of care.

Now say you learn while visiting the village clinic that an international pharmaceutical company is recruiting patients for a clinical trial testing a new anti-hypertensive drug. If you join the trial, you may only get the placebo. But there's a 50-50 chance you will get the new drug, which hasn't been proven yet, but might work.

Are there risks associated with taking this new drug? Well, so far, none that the doctors think are serious enough to cancel the trial. But it says right on the form that something may turn up in the clinical trial in which you are being asked to participate. You sign up. After all, a 50-50 chance of getting a drug that has a good chance of working (the drug industry wouldn't be here testing it if it didn't, right?) is better than no drug at all. And how much risk could there be, anyway?

Is that really non-coerced, informed consent?

[Update: There has still been no coverage of this development in the mainstream media, but Sonia Shah discusses it over at The Shah is the author of The Body Hunters: Testing New Drugs on the World's Poorest Patients.

See also bronxdoc's post at The Social Medicine Portal.]

Media Coverage of Genetically Modified Embryos

Posted by Jesse Reynolds on May 13th, 2008

Here is a roundup of some of the media coverage from the weekend's revelation that scientists have created a genetically modified human embryo:

The Times (UK) revealed the development on Sunday. Dr. David King of Human Genetics Alert said, “This is the first step on the road that will lead to the nightmare of designer babies and a new eugenics. The HFEA is right to say that the creation and legalisation of GM embryos raises ‘large ethical and public interest issues’ but neglects to mention that these have not been debated at all.”

The Associated Press carried a piece, "Genetically modified human embryo stirs criticism," late yesterday, which has been picked up by at least 150 news websites, quoting CGS's Marcy Darnovsky.

Today, the New York Times ran an article with a similar title, "Engineering by Scientists on Embryo Stirs Criticism," also quoting Darnovsky: "It’s an important ethical boundary that scientists have been observing. These scientists, on their own, decided to step over that boundary with no public discussion."

The Press Association (UK) distributed a video clip of Human Genetics Alert's David King (caution: clip is followed by a noisy advertisement):

Much of this was kicked off from a press release by Human Genetics Alert [PDF]. For more information, see HGA's brief [PDF]. CGS will be publishing more commentary on the first genetically modified human embryo soon.

Previously on Biopolitical Times:

Robert Winston on the UK's fertility bill

Posted by Jesse Reynolds on May 13th, 2008

Lord Winston
Robert Winston

Assisted reproduction pioneer Lord Robert Winston had some surprising words about the UK's controversial bill to overhaul its oversight of the reproduction industry and stem cell research. Two of the most controversial planks, for which there will be  conscience, are those regarding cytoplasmic animal-human hybrid embryos for stem cell research, and the selection of "savior siblings" through preimplantation genetic diagnosis. The Telegraph reported:

As for the Bill itself, [Winston] has an unexpectedly maverick approach. On human-animal hybrids, one of the most controversial issues, he says: "I'm really worried about saying this to you, because I know I shall get stick from my colleagues.

"But if the hybrid embryo thing doesn't go through, it in no way shakes the body of science. It's not [about] embryos that can survive, or viable monsters. Nothing like that.

"It's a nice adjunct; a useful extra. But if we don't have that resource, it won't fundamentally alter the science of stem cell biology."

Lord Winston has grave reservations about another disputed clause. "I'm very unhappy about 'saviour siblings'."

His concern is that children selected to provide treatment for a sick brother or sister may be put under undue pressure to give bone marrow or organs.

So it wouldn't break his heart if the measure was voted down? "Absolutely not," he says. 

Previously on Biopolitical Times:

Nature on California's "Cronyism"

Posted by Jesse Reynolds on May 9th, 2008

In a recent issue, the editors of Nature - among the most gung-ho supporters of stem cell research - caution against the "cronyism" and "inherent problems" at the California stem cell research agency. The editorial says:

Several episodes over the past year have highlighted an inherent problem with the CIRM's structure: the board that distributes its funding is stacked with representatives from the universities that benefit most from those disbursements. The CIRM has enacted rules to try to limit the conflicts of interest posed by this arrangement. They don't go far enough. At one meeting in January, for instance, CIRM board members from institutions that had applied for a facilities grant voted to deny one....

As the patient advocates grow into their roles as full partners, and with help from well-intentioned lawmakers such as Kuehl, the CIRM must be coaxed into serving its most important constituency — the taxpayers of California. The roles themselves are not unusual in the world of governance, but here the stakes are exceptionally high.

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