Drug and medical device industry launches push to weaken FDA oversight

With the Obama administration hobbled by a Republican-led Congress, the pharmaceutical and medical device industry seems to have launched a concerted push to roll back regulatory initiatives designed to protect consumers from unproven or unsafe drugs and medical devices. I’ve already written about the industry pressure that led to weakened NIH rules governing conflicts of interest here, but now deputies for the industry have trained their sights on regulatory actions taken by the Food and Drug Administration (FDA).

Here are two case examples. First: the effort by venture capitalists and their Congressional lackeys to further weaken the FDA’s already feeble approval process for new medical devices. As the New York Times reported this week, venture capitalists have intensified their lobbying in Congress in an effort to speed up the approval of new medical devices. This push, with millions of dollars going into the campaign coffers of friendly Congressmen and political action committees aimed at easing regulatory oversight, comes at the very time when press reports have shown that the FDA failed to adequately monitor medical devices that turned out to be harmful to patients, such as metal to metal hip replacements, spinal fusion products and some heart stents. As I’ve blogged about before, the FDA needs to beef up its oversight of new medical devices, not weaken it further.

The second case example involves a “working paper” that has been circulating about the impact of the FDA’s black box warnings that call attention to the increased rate of suicidal thoughts and behaviors among young patients taking antidepressants. The FDA imposed those black box warnings in late 2004 after discovering data in clinical trials done by the antidepressant makers themselves, which showed an increased risk of suicidality. (As I revealed in Side Effects, the drug makers hid this dangerous side effect from doctors and consumers for years, causing untold harm to thousands of children and young people).

The drug industry and its handmaidens in the psychiatry profession have tried for years to argue that the black box warnings led to an uptick in suicide rates among adolescents, a claim that has been thorough debunked by me and many others — see here, here and here. Yet this week, Pharmalot wrote about a working paper from an institution called the National Bureau on Economic Research that not only perpetuated this falsehood but also tried to link the black box warnings to poorer academic performance in depressed teenage girls who weren’t taking antidepressants.

But just what is the National Bureau on Economic Research and who funds it? As psychiatrist-blogger Mickey Nardo (1boringold man) noted this week, the head of the National Bureau on Economic Research until recently was none other than Martin Feldstein, a Harvard professor who has been on the board of Eli Lilly (the maker of several antidepressants) for years. In 2010 alone, Feldstein, who stepped down as head of NBER in 2008 and is still a research associate there, earned $301,000 from sitting on Eli Lilly’s board, according to this Forbes article.

According to Nardo’s research, the Bureau has received generous funding from Eli Lilly and other drug makers. Most recently, Karen Horn, another Eli Lilly board member and chair of its compensation committee, joined the board of NBER, as this article shows.

In addition, two of the authors of the NBER working paper – Susan Busch and Ellen Meara — have received grant funding from Eli Lilly for their research.

I guess we can’t fault the drug industry for trying to spin coverage and sell products. My question is: why do media outlets, like Reason magazine, which was the first to report on the results of this un-peer-reviewed and obviously biased working paper, keep falling prey to industry propaganda?

 

This entry was posted in antidepressants, conflicts of interest, FDA, medical devices, suicide rates and tagged , , , , , . Bookmark the permalink.

2 Responses to Drug and medical device industry launches push to weaken FDA oversight

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  2. Brad says:

    According to Wikipedia, NBER prides itself on publishing unbiased working papers. It’s pretty clear this one is biased.
    Economists are pretty familiar with journalists quoting working papers as authoritative. The most recent example was one by Munnell et al in the Boston Federal Reserve Bulletin. It reported discrimination in mortgage lending and may have led to the subprime crisis (Gretchen Morgenson & Joshua Rosner, Reckless Endangerment).
    Although NBER receives funding from drug companies, most of its funding comes from government grants. Also, they’re nonprofit or tax-exempt. So, any charge that they are functioning as mouthpieces for pharmaceutical companies, you would think, should be taken seriously by all concerned.

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