1 Boring Old Man

National Physicians Group Protests FDA Attempts to Allow Industry Influence
POGO
By PAUL THACKER
August 11, 2011

The uproar over attempts to loosen conflict of interest rules at the FDA has prompted a response from the National Physicians Alliance (NPA), a collection of doctors who advocate for patients and public health. Unlike most physician professional societies, The NPA does not accept funding from pharmaceutical or medical device companies. In a letter to FDA Commissioner Margaret Hamburg they wrote:

^{Unavoidable bias is introduced by reliance on industry-affiliated experts and has contributed to patient harms and scandals, such as FDA panelists with industry influence advising on decisions surrounding Vioxx. For this reason, we strongly encourage you to reconsider any loosening of conflict of interest rules for FDA advisers.}

To buttress their case, the NPA points to a study published last year by Mayo Clinic researcher Amy Wang in the British Medical Journal which found industry bias in researchers who were funded by pharmaceutical companies.In an accompanying opinion piece, BMJ Editor Fiona Godlee wrote:

^{Articles that gave a favourable view on the risks were significantly more likely to have authors with financial ties to the manufacturers of [diabetes drugs] in general, and [Avandia] in particular, than those with unfavourable views. The significant association persisted across a range of different methods of analysis.}

Godlee also took to task the FDA office headed by Janet Woodcock, which approved first Avandia and then sought to keep the drug on the market over objections of safety offices inside FDA.

^{People are now suggesting that the decision on whether to remove a drug from the market should not be made by the same people who approved the drug in the first place. I agree. What we urgently need is independent post-marketing surveillance.}

The pushback against the FDA is getting more and more forceful, and has not escaped the notice of Politico or the British Medical Journal.  As we mentioned in the past, the whole affair seems to be orchestrated by FDA’s Janet Woodcock, who appears to be ignoring facts, in favor of rewarding her friends in industry…

Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off
Healthcare Renewal
by Roy Poses
August 8, 2011

Weakening FDA Conflict of Interest Rules

As reported by Reuters,

^{U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts. Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.}

This was not purely an initiative of legislators, but was egged on by a top FDA administrator

^{The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants. ‘We have had difficulty in recruiting highly qualified people. And we’ve had delays in having panels because of this,’ Dr. Janet Woodcock, head of the FDA’s drugs center, told a House of Representatives hearing earlier this month. The result is that 23 percent of FDA advisory panels have vacancies, more than double the agency’s stated goal, according to the FDA’s quarterly report at the end of May.}

The rationale was that those paid by drug and device companies are the most expert:

^{The FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist’s view, partly inspired by the scandal with Merck’s pain reliever Vioxx. Ten of the 32 panelists advising the FDA on the drug consulted for drugmakers. Nine of the 10 recommended putting the drug back on the market after it was pulled in 2004 over concerns about heart risk.}

^{The restrictions go too far, say lawmakers who want the FDA to approve more new medicines, in part because they promote American jobs. ‘No longer can we deny experts simply because they have ties to industry,‘ said Georgia Representative Phil Gingrey during a House of Representative hearing on FDA funding last month. The committee’s chairman, Fred Upton from Michigan, called the conflict of interest rules ‘rigid and unrealistic.’}

^{Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules. Biogen Idec CEO George Scangos said the guidelines ‘exclude a lot of people who would be the best qualified.’}

Of course, the drug and device companies have been touting their paid "key opinion leaders" as the best and the brightest for a long time. There is plenty of evidence, however, that they are mainly those whom those companies find the most compliant, and in many cases, those who are willing to be stealth marketers on those companies’ payrolls.  "Key opinion leaders" supported by commercial grant funding may seem like experts to academic medical institutions’ leadership who now value outside funding more than teaching and research excellence.

Furthermore, as reported by Politco, the Project on Government Oversight, a watchdog group, chastised FDA leadership for exaggerating the difficulty of finding unconflicted experts, concluding in their letter to the FDA Commissioner, "to gain the public trust, we must ensure that the FDA relies on the best available information for its policies, rather than personal opinions and biases."  So far, government officials seem to be more worried about the opinions of corporate leaders than the public trust…