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Goozner and the Integrity in Science Project on Conflicts at the FDA

Posted by Jesse Reynolds on December 3rd, 2007

Like the National Academies, the Food and Drug Administration recently reviewed its conflict of interest policies. And once again, the Integrity in Science Project at the Center for Science in the Public Interest offered a useful take on the findings:

When the original 2001 Vioxx study appeared in the New England Journal of Medicine, its industry-funded authors dismissed data showing the drug raised the risk of heart attack by suggesting the comparison drug in the trial had been cardio-protective. Last month, the Food and Drug Administration did something similar with a study [PDF] of conflicts of interest on its advisory committees. The agency's press release said it would be difficult to create advisory committees free from conflicts of interest. The study, which cost taxpayers $60,000, according to, also claimed the advisors granted conflict-of-interest waivers had greater expertise than those without conflicts serving on the committees.

In fact, a Center for Science in the Public Interest reanalysis of the data contained in the report revealed that the FDA and the report should have drawn the opposite conclusions. The report examined four committees created during 2006 that granted 17 waivers. It took just 88 person-hours to identify 30 independent experts with all the expertise needed to fill those slots. Each of the 30 affirmatively declared in the medical literature that they had no conflicts of interest. Moreover, the expertise of those potential candidates, according to the report's own methodology, was greater than either the conflicted or unconflicted experts chosen to serve on the committees.

In a letter [Word Doc] sent today to Commissioner Andrew von Eschenbach, a coalition of consumer groups called on the FDA to reopen consideration of an agency proposal made last March that would forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts. "While the FDA's proposed guidance doesn't go far enough, this study shows that those barred or restricted under its limited provisions could be easily replaced," said Merrill Goozner, director of CSPI's Integrity in Science Project. Recently passed legislation only requires the agency to reduce total waivers by 20 percent over the next five years, which is well short of the total ban on conflicts of interest sought by consumer groups.

Merrill not only directs the project but has written a widely-praised book on the costs of drug development, and maintains his own blog, Gooznews. Both come recommended.

Defensive Ideologues Dig In

Posted by Jesse Reynolds on November 30th, 2007

Isaac Newton, responsible for some other great scientific advances in human history

In the wake of last week's development of patient-specific, pluripotent stem cell lines, I've read much pontification and punditry. Some is thoughtful, plenty is glib, and the occasional nugget is simply ridiculous. Here are three examples of the latter, all from entrenched embryonic stem cell research ideologues - with financial interests in the field - who are resorting to defensive posturing.

Leading the pack is Michael Werner, lobbyist for the Biotechnology Industry Organization, who laments that these "scientific discoveries are being politicized." Yet his job is to do precisely that: He spins scientific developments in ways that encourage politicians and other policy makers to enact policies friendly towards the industry that signs his paycheck.

Next up is Geron CEO Thomas Okarma, who said: "Most of the people who are doing this work and make the claim that this is going to change the therapeutic field really know nothing about cell therapy." This sentence clearly points to the actual researchers who developed the new techniques, including James Thomson. So to Okarma, whose repeated promises of clinical trials for embryonic stem cell therapies make them seem as imminent as Chinese Democracy, the very scientist who first isolated human embryonic stem cells "really know[s] nothing about cell therapy?"

Finally, in an attempt to downplay the new methods of deriving stem cells without embryos, Okarma's BFF Hans Keirstead said that embryonic stem cells (i.e., the type on which he holds patents) are "are the greatest single scientific advance in human history." I'll let that statement speak for itself. (HT to Wesley Smith on Keirstead)

DNA Dieting? It was only a matter of time.....

Posted by Jamie Brooks on November 28th, 2007

(Click on Image)

The United States is dealing with skyrocketing obesity rates at the same time we are becoming obsessed with thinness. This has created a market for Americans to be inundated with diet advertisements for quick fixes promising weight loss.

It was only a matter of time before biotechnology would promise people that it could help them get their sexy back while capitalizing on the multi-million dollar diet industry. Enter GenoTrim™, the "world's first DNA-customized nutritional supplement for optimal weight."

GenoTrim™ advertises that for $495 you can take the GenoTrim™ DNA test. This, it claims, will detect your genetic imbalances by analyzing what it calls the "sweet tooth gene," "nervous eating gene," "fat regulator gene," "new cell gene" and the "obesity risk gene." Then, for $99 dollars a month, you can buy a supply of genetically-guided nutritional supplements customized uniquely for you.

The asterisk mark following these statements should come as no surprise. The caveat: "The supplement is most effective when working in conjunction with a reasonable diet and exercise plan…These statements have not been evaluated by the U.S. Food and Drug Administration."

Personalized medicine sounds like a promising approach, but it is still too early to gauge how useful it will be. And, due to the fact millions of genetic variations may exist, identifying them all, and having an accurate understanding of how genes interact with one another may make the fruits of genetic medicine more distant than its proponents would like to admit. Nevertheless, the GenoTrim™ service has already launched, with an expected $70 million in sales over the next five years.

Obesity is certainly a health risk. But as the medical industry and the media increasingly embrace genetic explanations for almost every health condition, will the age-old adage of eating less and exercising more find itself in smaller and smaller print until it finally vanishes?



Biopolitical Times at One (plus) Year

Posted by on November 27th, 2007

This blog has reached - and slightly passed - its first birthday. To mark the occasion, each of us "regulars" chose our favorite posts written by the others. If you have some favorites from our first year, let us know in the comments.

by Jesse Reynolds
July 20th and August 3rd, 2007

Geron, the leading private firm trying to commercialize human embryonic stem cell products, has stated that clinical trials will occur "next year" - for the fourth year in a row.

by Jesse Reynolds
May 24th, 2007

A recent article on potential economic benefits from California's $3 billion investment in stem cell research relies on the over-the-top - yet widely-cited - scenarios spun in an economic analysis that was funded by the campaign to establish the state program . Not only that, the recent claim and the PR piece it cites share an author.

by Osagie K. Obasogie
May 18th, 2007

Judging from CNN's recent episode of "Paula Zahn Now," eugenics isn't the only pseudoscience threatening to make a comeback. CNN's Senior Medical Correspondent Dr. Sanjay Gupta took things to a whole new level.

Cloning human beings? The "inevitability" power play

by Marcy Darnovsky
February 22nd, 2007

It's one thing to hear about the "inevitability" of human reproductive cloning from kooks. But from the editors of Nature?

by Osagie K. Obasogie
November 20th, 2006

Last week's Nova had an intriguing segment on members of a rural Muslim Turkish family that, strangely enough, walk on their hands and feet. What's fascinating, however, is not simply that they are quadrupeds, but how some evolutionary geneticists are using this family to put forth theories on the genetic cause of human bipedality, or our ability to walk upright.

by Marcy Darnovsky
October 26th, 2006

This week's stem cell ads reach new lows of emotional manipulation in an already degraded debate. And with the help of YouTube, they're reaching stratospheric new heights in political influence.

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