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Yet More Meddling at CIRM

Posted by Jesse Reynolds on December 7th, 2007


New revelations of improper interference in grant applications by board members of the California stem cell agency surfaced today. The San Francisco Chronicle reports that four members of the California Institute for Regenerative Medicine (CIRM) board, who are also deans of medical schools in the state, have written letters of support for recent grant applications from researchers at their own institutions. This appears to violate Proposition 71, which prohibits board members from trying to influence applications from their institutions.

Coupled with recent news that one such inherently-conflicted board member tried to salvage a rejected grant to his institution - at the suggestion of board chair and Proposition 71 author Robert Klein - this suggests a board culture that does not take conflicts of interest seriously. The picture seems even sharper in light of CIRM board members' personal financial interests in companies that are invested in stem cell research, documented in a CGS report in April 2005.

The current situation developed after applicants for CIRM grants were instructed to obtain letters of support from their department chairs or deans, without mentioning that conflict-of-interest considerations would rule out letters from deans who are also CIRM board members. But these board members, who are executives at heavyweight institutions - UCSF, UCLA, UCS­D, and USC - should know better. It would have been a simple matter for them to refer the applicants to assistant deans or department chairs.

Both in this case and in the one involving Robert Klein and board member John Reed, CIRM staff should be praised for catching and rejecting the inappropriate interference.

Credit or blame aside, this meddling is symptomatic of the deep flaws of Proposition 71, which created CIRM. It mandates that the CIRM board be dominated by high-ranking representatives of the institutions vying to maximize their slice of the public funding pie. These developments should stimulate the California legislature to alter the law to reform the board structure, and more.­

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The New York Times’ New Hitman

Posted by Osagie Obasogie on December 5th, 2007


John Tierney has been writing for the New York Times for quite a while. But his most recent beat has entailed covering science and technology, where he has drunken the biohype kool-aid that's apparently on tap at the Times' watercooler.

Tierney's most recent example of reporting while intoxicated can be seen in his article on religion and cloning, where he not so subtly suggests that only Western religious zealots find fault with the idea of cloning human beings. His proof? The Far East. If people in Asia (who are largely non-Christian) don't have a problem with reproductive or research cloning, then, as Tierney's shoddy armchair sociology leads him to conclude, religion must be the key variable. And, the argument goes, since religion is by definition irrational, so too is any opposition to cloning a human. Tierney lays out his full manifesto in a blog post on the Times' website entitled "Who's Afraid of Soulless Scientism?"

This strawman argument pitting religion and science as irredeemably feuding entities both overestimates religion's role in how people think about reproductive cloning and underestimates the very real social harms that may come from it. One need not resort to a belief in God to think that human cloning is a bad idea.

First, any effort to clone a person is nothing short of unethical human experimentation. Reproductive cloning in animals typically leads to scores of stillborn and deformed clones before a viable one is born. And their surrogates often don't fare much better. Subjecting humans to this would be barbaric. Second, like research cloning, reproductive cloning relies heavily upon women's eggs and endangers those who undergo egg extraction - a painful and dangerous endeavor that has lead to serious complications and even some deaths. Third, reproductive cloning doesn't serve any reasonable medical purpose. Cloning a dead or living person might intrigue some, but this twisted fantasy is certainly outweighed by other dangers.

Thus, the problem isn't necessarily that science might lack a soul. It's that advocates like Tierney often lead it to lack decency.





Stem cell cheerleading and hand-wringing at The New York Times

Posted by Marcy Darnovsky on December 4th, 2007


A few weeks ago, the New York Times provided a chunk of its front page to an enthusiastic news article that, in the words of bioethicist Erik Parens, “gave free advertising to three companies that already are or soon will be hawking whole-genome scans” – procedures that experts have described as a waste of money at best. Parens’ pointed remarks are titled, “It’s Time for the Times to Cut the Gene Hype.”

The Times has another biotech hype problem, too, this one on its editorial page, where over-the-top stem cell fervor long ago left thoughtful assessment behind.

In recent years, the nation's newspaper of record has made a habit of jumping in with a cheerleading editorial just about every time an embryonic stem cell researcher sneezes – a total of 58 editorials focused on stem cells since the summer of 2001.

But last month’s announcement that ordinary skin cells can be transformed into human pluripotent stem cells seemed to leave the Times editors at a loss for words. Nearly two weeks later – during which time dozens of other editorials, columns and commentaries appeared in news outlets around the world – a party line had developed, and a Times editorial toed it.

The editors expended most of their energies on Bush-bashing – a tempting pastime, to be sure – and making the case for continued research on IVF embryos – a point with which even many Republicans agree. The editorial was also saturated with the assumption that cloning-based stem cell research is still necessary, and that regulating stem cell research is not.

These are dubious assertions, but in keeping with the Times editors’ stem cell drumbeat.

Times editorials routinely conflate the distinction between stem cells derived from IVF embryos slated for discard – that is, all currently existing embryonic stem cells – and the so-far unsuccessful efforts to get stem cells from cloned human embryos – efforts that raise a number of non-embryo-related concerns, including the fact that they require thousands of women’s eggs.

When the Times editors do mention eggs, their tone shifts from cheerleading to hand-wringing. In September, for example, Biopolitical Times noted their lament about the “distressingly few women willing to donate their eggs for experiments at the frontiers of this promising science.” The editors consistently ignore or downplay the risks of egg extraction for women. In this Sunday’s piece, they refer to the need for “large quantity of human eggs” as “the vexing problem.”

The Times’ final thought in Sunday's editorial is the hope that “the next president will quickly jettison all restrictions on stem cell research.” All restrictions? Do they really want no rules at all? Based on a perusal of New York Times stem cell editorials from 1998-2007 – see this compiled list – that sorry conclusion seems inescapable.





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 FedSpending.org, 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.





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