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Jensen on CIRM; Klein on Clinical Trials

Posted by Jesse Reynolds on November 12th, 2007

The premier observer of the California stem cell research agency, David Jensen of the California Stem Cell Report, has published an in-depth review of the California Institute for Regenerative Medicine. Noting the third anniversary of the passage of Proposition 71 in Sunday's Sacramento Bee, he highlighted a number of points that we at the Center have consistently argued: unfulfilled promises, conflicts of interests, lack of transparency, and the "polarizing" nature of CIRM board chair Robert Klein:

But by other standards, including its own strategic plan, the institute doesn't measure up. The money is not flowing as fast as called for. Rosy campaign promises of cures and an economic boom still await fulfillment. Built-in conflicts of interests pervade the institute's activities. A penchant for closed-door grant reviews and secrecy screens much of the institute's most important decisions from public view. And, more than once, calls have arisen for the resignation of its chairman, Robert Klein, a man who triggers both admiration and animosity....

The institute, however, is controlled by men and women accustomed to operating outside of the public eye with few of the restraints that even local school board members face. Many come from the culture of science, where the motto sometimes seems to be: "Trust us. We are the experts."

But given the built-in conflicts at the agency, more sunshine is needed - if only to help avoid a scandal that could set back stem cell research efforts nationally and cast a pall over this creative governmental experiment.

As part of his research for the retrospective, Jensen posted in his blog a statement from Robert Klein, California's "stem cell czar." In it, Klein argues that "the board and the agency need to launch a major public information program, including a specific focus on the upcoming human embryonic stem cell clinical trials."

He's probably referring to the announcements by the two leading private embryonic stem cell research firms, Geron and Advanced Cell Technology, which recently touted their plans to move forward with trials next year.

Klein should be careful to hang too much on the statements of Geron and ACT. The former has been giving us the "clinical trials next year" line for four years running. And the latter has a history of exaggerating its achievements, likely in order to maintain investment.

Nano-particles in sunscreen: Donít get burned

Posted by Marcy Darnovsky on November 8th, 2007

Some sunscreens currently on drugstore shelves contain nano-particles. But you'd never know, because they're not labeled. And no government agency has reviewed them to see whether they're safe.

Instead, the US Food and Drug Administration has relied on manufacturers' assurances that there's no problem with smearing the nano-containing creams all over the skin - despite concerns that nano-particles may be able to penetrate the skin and cause damage once inside the body.

The International Center for Technology Assessment has launched a campaign to gather and submit public comments to the FDA by November 26. Take a look at the information and it's compiled and the comment form it provides.

Stem Cell Research in New Jersey: The Beginning of the End of Hype?

Posted by Jesse Reynolds on November 7th, 2007

Yesterday, New Jersey became the third state in four years to present its voters a ballot question on embryonic stem cell research. But unlike the citizens of California and Missouri, those of the Garden State rejected theirs, which proposed $450 million in bonds to expand the existing state funding program. Most analyses in the media assert that it was rejected for fiscal, not moral, reasons. Though the evidence remains inconclusive, if this is true, it is noteworthy.

Unlike those of the other two states, the New Jersey ballot question [PDF] originated in the state Legislature and consequently mobilized less on-the-ground support. For example, the website of the state's Citizens Coalition for Cures barely mentions the ballot question.

Furthermore, the public debate - both pro and con - focused much more on the economics than in the previous debates. The state debt, which now stands at $33.5 billion, has been a top issue in recent years. Plus New Jersey is already in the stem cell business. The legislature has already allocated $150 million to construct stem cell research facilities, and allocated another $10 million for research grants.

What's more, New Jersey voters have been historically friendly to ballot initiatives. This one, and one other on the same ballot, became the first to fail in seventeen years. That other was an anti-tax measure, which also would have increased the public debt.

Finally, polls have indicated that state residents support a woman's right to terminate a pregnancy by a 2 to 1 margin. Thus, factors other than the moral status of the embryo must have greatly contributed to the 53% vote against Public Question 2.

Three years ago, in California, the economic cost of the $3 billion Proposition 71 was merely a minor part of the public debate, overshadowed by the promises from the state's top researchers of treatments and the now-prerequisite images of hopeful children in wheelchairs. Missouri's ballot initiative of last year didn't set aside any public funds; it merely enshrined the legality of the work in the state constitution. Despite the efforts of the advocates there to shift debate to purported economic benefits, the issue remained a moral one to most voters, particularly opponents. Missouri's Amendment 2 barely succeeded only after an enormously expensive campaign by its supporters. Also that year, congressional candidates who were vocally supportive of embryonic stem cell research did not fare particularly better than Democrats as a whole. Perhaps the sheen and hype of imminent cures is beginning to wear off of embryonic stem cell research.

Conflicts of Interest at the National Academies' Committee on Conflicts of Interest

Posted by Jesse Reynolds on November 6th, 2007

The National Academies, a set of four nonprofit organizations closely affiliated with the federal government, are held in high regard and often touted as providing the "gold standard" in objective scientific advice. But critics such as the Integrity in Science project of the Center for Science in the Public Interest assert that conflicts of interest are a major problem on the Academies' advisory committees. For example, a 2006 CSPI report [PDF] concluded that "Nearly one out of every five scientists appointed to an NAS panel has direct financial ties to companies or industry groups with a direct stake in the outcome of that study."

So perhaps it shouldn't have been too surprising that when the Institute of Medicine, one of the Academies, established a panel of experts to create guidelines for managing conflicts of interest in all aspects of medicine (education, practice, and research), a sizable portion had conflicts of interest. These conflicted members were provided waivers, which are given out with regularity and apparent ease. In response to criticisms such as those from CSPI, the IOM merely added two members, albeit two experienced in critiquing conflicts of interest in medicine. 

Irony? Tragedy? Farce?

The committee wraps up its first two-day meeting today.

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