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Nature Biotech reports CGS skepticism about IRBs-for-hire

Posted by Marcy Darnovsky on February 5th, 2008

Jolee Mohr

Here's a belated pointer to an article published last September in Nature Biotech. "Death in gene therapy trial raises questions about private IRBs" opens with concerns raised by Biopolitical Times' own Osagie Obasogie, in an op-ed about Jolee Mohr's summer 2007 death in a gene transfer trial for rheumatoid arthritis sponsored by the biotech company Targeted Genetics:

[T]he institutional review board [IRB] charged with ensuring that the trials were conducted ethically is a for-profit enterprise also on Targeted Genetics' payroll. When a review board is being paid by the company that it is supposed to oversee, incentives often lean the wrong way: toward helping industry profit and away from patient safety. Such practices are common in today's clinical trials, and they put people's lives in danger. With so much money in play and so little enforceable oversight, corners may be cut more often than we'd like to think.
The FDA allowed the trial to resume in late November, saying that the gene transfer product was not responsible for Mohr's death. But a few days later, the NIH committee responsible for overseeing gene transfer tests reached a different conclusion, refusing to rule out the experiment as a factor.

We'll probably never know for sure. But as Osagie pointed out in his op-ed, "[T]his isn't simply about regulatory failure. It's also about how profit motives embedded in the clinical trial process can undermine patient safety."

Those who don't know (recent) history

Posted by Jesse Reynolds on January 31st, 2008

Daniel Sulmasy

While I was away from my desk last week, a member of the ethics committee of New York's stem cell research program accused the new $600 million agency of ignoring the committee's recommendations and "steam-rolling" ethics in the process. Granted, this committee member, Daniel Sulmasy, is an opponent of embryonic stem cell research and likely has an ax to grind. But in his op-ed, he claims that the committee, realizing that there was pressure to get funds out the door as soon as possible, unanimously recommended that grants go only to noncontroversial research for a few months, allowing the committee the time to draw up research standards. But the Empire State Stem Cell Board rejected this, worried that it would "send the wrong message to scientists." Sulmasy concludes:

This precipitous funding decision sends the wrong message - namely, that the discussion of research ethics should never encumber scientists' work. That's a dangerous premise for any society to hold. Was a six-month delay to allow ethical review really too much to ask? It's preposterous to propose that this would've had a "chilling effect" on science.

New York citizens deserve a serious ethical review of how $600 million of taxpayer money will be spent on a potentially valuable but extraordinarily controversial field of research. If the ethics committee had been permitted to do its job seriously, the whole nation might have benefited from a rigorous, public, dispassionate debate of the weighty ethical issues at stake.
Not surprisingly, the governor was able to hold a press conference, touting the first round of $14.5 million in funding.

These developments have an element of déjà vu. At the first full meeting of the nascent California stem cell research program in January 2005, board chair Robert Klein announced his intention to get funds out the door by May. We and other public-interest advocates pointed out the lack not only of research standards, but also of intellectual property policies and any resemblance of a strategic plan. Fortunately, in California's case, a mix of our advice and circumstance prevailed, and policies were in place before the first research grants were awarded in February 2007.

Unfortunately, the leaders of the New York program seem to have not learned lessons from the California experience.

Genetic Information as Fashionable Fetish

Posted by Jesse Reynolds on January 31st, 2008

Davos, Switzerland

The blog of T Magazine, the New York Times' publication on "fashion, design, food, and travel," reports that, at the World Economic Forum:

this year's must-have Davos accessory is a personal DNA map, which provides the ultimate knowledge of personal style by determining just what traits you may or may not possess - from cancer to attached earlobes to what? A weakness for cashmere?
Yes, genome scans offered by the well-connected 23andMe are now a fashionable fetish among the world's elite. The blogger concludes:
The thought of what's gone on at Davos - mapping the genome of hundreds of the world's most powerful people all in one week - raises a number of questions: Will connected comparisons reveal a greed gene? Is there a causal link between teaching economics and baldness? Never mind the legal, moral, ethical, risk and privacy implications; mixing science with genomics with social networks will likely provide an information cocktail too potent to ignore.
Update: 23andMe apparently distributed one thousand free kits to the world's elite at the Davos gathering - a wise marketing tool, indeed.

The New Republic Asks Whether Baseball is Already Losing the Next Doping Battle

Posted by Osagie Obasogie on January 29th, 2008

Senator George Mitchell's 20 month investigation and subsequent report on the use of steroids, HGH, and other performance enhancers in baseball has rocked the sport to its knees. The proverbial asterisks no longer belongs solely to Barry Bonds, as fan favorites such as Miguel Tejada and Roger Clemens are also on the long list of players who are suspected of cheating their way to the top. But the folks over at The New Republic blog have shifted the focus of baseball's scrutiny from past to future by asking whether the sport is already losing the next big doping battle. In addition to the medical exemption loophole and the growth of HGH use in the absence of any tests to detect it, TNR takes a good look at gene doping, noting

This is the most speculative, but far-reaching, cheating strategy on the horizon: the possibility of using gene therapy to improve athletic performance. It's certainly unrealistic to expect baseball to have any well-defined strategy yet for dealin­g with it, but when Rep. Mark Souder (R-Ind.) asked [Major League Baseball Commissioner Bud] Selig about it, Selig seemed not to understand what Souder was talking about. He asked Souder to repeat the question three times, and then gave a brief, generic answer about baseball having hired the best anti-doping doctors in the country. This doesn't inspire much confidence that baseball will be ahead of the curve.

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