FDA May Relax Conflict of Interest Rules on Adviosry Panels

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

FDA May Relax Conflict of Interest Rules on Adviosry Panels

PostPosted by DCNGA » Wed Sep 28, 2011 11:36 am

The FDA is not on the consumer's side. They are there to placate and make it easier for device makers to get their products to market more quickly with less oversight. Senator AL Franken has an initative afoot to relax the rules. Write your Congressmen/women and Senators to stop this dangerous initiative.

This is why cosmetic devices are pushed through more quickly. The FDA does not have the time nor the desire to protect those like ourselves as cosmetic medical devices are not a high priority for the FDA. Get 'em in, get 'em approved, get 'em on the market mentality is harming all of us.

An FDA move to relax conflict-of-interest rules governing advisory panels is meeting with heated opposition from watchdog groups and medical societies.

FDA commissioner Margaret Hamburg recently told Public Citizen that the agency may loosen a three-year-old policy aimed at keeping industry-funded physicians off FDA advisory panels because the resulting vacancies are gumming up the approvals process.

An FDA spokesperson told MM&M: “The new conflict of interest rules have, in some cases, made it more difficult for FDA to find expert advisors. In most cases, FDA has been successful in finding experts to meet our needs. However, in a few cases it has been necessary to delay holding advisory committee meetings in order to allow more time to contact and screen more experts for consideration or to begin the screening process with many more experts. This increases the work requirement for advisory committee preparation.”

As of March, 23% of the agency's advisory committee seats – 138 of them – were vacant.

FDA CDER director Dr. Janet Woodcock said at a conference in May: “There is no doubt it is difficult finding highly experienced people who do not have conflicts.”

Bull, said the Project on Government Oversight (POGO), arguing that the number of conflict-of-interest waivers granted FDA advisory members has never exceeded 5% and that the percentage of seats vacant is falling, having sunk from 30% in 2009.

“These rules do create an additional hurdle, but that is exactly the point,” said POGO head Danielle Brian in a letter to Dr. Hamburg. “We want expert advice that is as free as possible from the influence of industry.”

Like POGO, the National Physicians Alliance pointed to lists of conflict-free physicians.

“We understand and decry the increasing entanglement of many researchers and clinicians with industry and understand that finding reviewers without conflicts can be a challenge,” said National Physicians Alliance president Valerie Arkoosh, MD, who noted that almost half of the cardiologists who develop clinical practice guidelines for the American College of Cardiology and the American Heart Association do not have conflicts of interest.

In the FDA's corner on the topic is House Energy and Commerce Committee chair Rep. Fred Upton (R-MI), who said in July: “The rigid and unrealistic conflict of interest provision has prevented FDA and its advisory committees from utilizing some of science's best minds and left advisory committee slots unfilled,” and suggested that the rules have slowed approvals.

Another voice in favor of relaxing the rules is that of Peter Pitts, an industry PR man and generally pro-industry think tanker who, as FDA associate commissioner, was in charge of advisory committee oversight, in which role he had final say on what would-be panelists with conflicts made the cut and were granted conflict of interest waivers.

“Many did not,” wrote Pitts, “but those who did received their waivers because FDA professional career staff made a strong case that these people weren't just important to the advisory committee but critical. And we should all pay attention to the nomenclature. It's not about ‘conflict of interest' – it's about (as HHS Secretary Sebelius correctly says) ‘interest.' And having an ‘interest' is not necessarily a bad thing as long as you're transparent about it.”

“If we allow FDA adcomms to become the realm of the second best and the almost brightest,” continued Pitts, “What have we done to the advancement of America's health?”
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA May Relax Rules on Conflict of Interest on Adviosry

PostPosted by DCNGA » Wed Sep 28, 2011 11:42 am

The FDA is a sham:

FDA may loosen confict-of-interest rules, commissioner suggests
By Susan Perry | Published Mon, Aug 8 2011 9:46 am

Concern is growing over comments U.S. Food and Drug Administration Commissioner Margaret Hamburg made recently about loosening the FDA’s conflict-of-interest rules for who can serve on its expert advisory panels.

Margaret HamburgThese are the experts who advise the FDA about which drugs and medical devices should be approved — and which ones should be pulled off the market when evidence suggests the products are unsafe and/or ineffective.

Since 2008, experts with financial conflicts of $50,000 or more are barred by FDA rules from participating on the agency’s 50 or so expert panels. Waivers are sometimes issued, but only if strict guidelines are followed.

Hamburg now appears to want to weaken those rules. She says her agency is struggling to fill the FDA’s advisory panels with knowledgeable experts who are free of financial conflicts of interest.

Balderdash (or words to that effect), say health-care watchdogs.

An existing list
One of those watchdogs is Minnesota’s own Gary Schwitzer, a former University of Minnesota journalism professor and current publisher of the website HealthNewsReview. Last week, Schwitzer sent a letter to Hamburg in which he referred the commissioner to a list of “industry-independent experts” that he posts on his website for journalists to use.

He suggests that Hamburg try those experts if she's having trouble filling the slots on her advisory panels.

The list was initially put together in 2008 by two journalists, Jeanne Lenzer and Shannon Brownlee (now acting director of the New America Foundation Health Policy Program). Both women co-signed Schwitzer's letter to Hamburg.

“The list includes some of the most renowned researchers, epidemiologists, and specialists in the world,” the letter states. “… We are revising the list and updating it with the most recent contact information and new members. We will gladly forward the new list to you as soon as possible. Given the recent scandals involving industry influence on clinical guideline writers, FDA advisors and academic researchers and clinicians, we hope you will reconsider the necessity of loosening conflict of interest rules for FDA advisors.”

Courtesy of HNR
Dr. Gary SchwitzerThe nonprofit Project on Government Oversight also sent a letter to Hamburg last week in which it pointed out that it’s still possible to find highly qualified experts who are free of industry ties:

“According to a federally funded study of 2914 academics published in Health Affairs and presented at Georgetown University in June, almost half of U.S. academic researchers have no relationship with industry. Around one-third of these researchers are full professors. Furthermore, a study published in the Archives of Internal Medicine surveyed hundreds of experts who helped create clinical care guidelines published by the American College of Cardiology and the American Hearth Association. Forty-four percent of those participants had no financial conflicts.”

Pressure from politicians
The FDA has been under mounting political pressure to speed up its review process for new drugs and medical devices. As noted by Bloomberg News, “Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers.”

But Republicans aren’t the only ones in Congress who are pushing for a faster review process. Earlier this summer, Minnesota’s entire Congressional delegation sent a letter to Hamburg stating that they were “very concerned” about the slow speed of the Investigational Device Exemption (IDE) review process.

Minnesota is, of course, home to several of the largest medical device companies in the world.

But, as Brownlee noted on the New American Foundation website last week, “where’s the evidence that conflict of interest rules are delaying truly effective drugs from reaching patients?”

The danger to consumers, she pointed out, comes when conflict-of-interest rules are too weak, as past FDA history has shown.

“To take just one ready example,” she wrote, “in 2005 an FDA advisory panel voted to keep painkillers Vioxx, Bextra, and Celebrex on the market, despite mounting evidence that Bextra and Vioxx significantly increased patients’ risk of heart attack, stroke and death. Ten of the 32 members of that panel had financial ties to manufacturers. Out of 30 votes cast by those ten, 28 were in favor of keeping the three drugs on the market.”

“Loosening conflict-of-interest rules at the FDA seems particularly wrongheaded in the wake of recent scandals involving researchers and physicians whose industry ties appear to have biased their judgment,” Brownlee added. “Last month, three Harvard psychiatrists were sanctioned for violating their university’s conflict-of-interest policies. The most prominent of the trio, Joseph Biederman, is widely credited with promoting the use of powerful drugs known as atypical antipsychotics in children. These drugs have turned out to have devastating side effects for many patients. Biederman earned an estimated $1.6 million in consulting fees from the drugs’ makers between 2000 and 2007, but failed to report the income to Harvard as required.”
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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