The president of Consumers Union, Jim Guest, testified that improvements are needed to prevent future disasters like Vioxx and called for a rule requiring that at least 90% of the members who decide whether a drug should be approved be free of conflicts of interest.
Dr. Steven Nissen, of the Cleveland Clinic, who has served on advisory panels, testified to "a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety" and called the Senate reform bill a "major step forward."
"I served on a 2001 Advisory Panel that recommended a warning label for Vioxx," he told the Senators, "but it took 14 months before the FDA could secure agreement from the company to accept a weakly written warning."
Dr. Nissen also said improvements "in the Advisory Committee process will help to ensure that FDA consultants are less likely to be influenced by financial conflicts of interest."
In 2005, a law was passed that required panel members to make full disclosure of all financial ties to Big Pharma. However, after reviewing the disclosure forms submitted, the FDA is still permitted to grant waivers that allow experts to sit on panels even if they have financial ties to a drug company.
On April 21, 2006, the Boston Globe discussed the practical effects of the law since it was enacted and quoted FDA critics as saying "the new transparency has changed little, and scientists who have conflicts of interest can still guide FDA decision making."
In less than 6 months, the Globe determined, close to 100 waivers had been granted.
Congressman Hinchey is the author of an amendment to the spending bill that funds the FDA, which would ban waivers. "Plain and simple," he says, "if a doctor or scientist has a personal, financial stake in a drug they should not be allowed to sit on an FDA advisory panel and determine whether that drug is safe."
In response to the FDA's renewed push to maintain its ability to grant waivers, on July 24, 2006, Rep Hinchey released a statement stating, "The FDA continues to demonstrate a lack of commitment to ensuring that all of its advisory panels are filled with members who have no conflicts of interest with the drug or device being reviewed."
"Saying that there are not enough potential advisory panel members available without conflicts, as the FDA argues, is an empty claim," he said.
Most disturbing, he said is that the FDA denies only 1% of the waivers requested. "When the FDA is handing out waivers 99 percent of the time," he states, "it is a clear sign that the system is broken."
No doubt in attempt subdue the hornet's brought on by the investigations into the approval of Ketek based on fraudulent studies, in late July 2006, the FDA announced a series of changes it plans to make in the methods used to evaluate clinical trials.
One would require a company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial. As it is now, drugs companies are trusted to remove unreliable data and are not required to report any fraudulent activity to the FDA until they actually submit the new drug application.
The agency also says it plans to clarify which adverse events must be reported to the review boards that monitor the studies and standardize the forms used to collect information and revise the rules on how patients may qualify to participate in clinical trials.
The new FDA commissioner was confirmed on December 7, 2006, but critics say the agency is incapable of change under the Bush regime. Rep. Hinchey released a statement stating: "Unfortunately, the Senate's confirmation of Dr. Andrew von Eschenbach represents anything but a fresh start for one of the most troubled agencies in the federal government."
"I have not seen anything substantive from Dr. von Eschenbach," he stated, "to make me believe that the mismanagement, misplaced priorities, and ineptitude of the agency's leadership will change during his tenure."
who don't have some stock in big pharmaceutical companies in their portfolios.
Of course they don't know what's in their portfolios, because they are in escrow or behind a firewall, like Dick Cheney's Halliburton profits, so they don't actually have a conflict of interest.
So when they don't overhaul the FDA it will just be a coincidence, see?
And if they pretend to try to overhaul the FDA, and Bush vetoes their efforts, it won't be because they refused to impeach him, it will be Ralph Nader's fault. If he and his damned consumer-safety anti-corporate agenda hadn't been on the ballot in 2000 and 2004, the Democrats could have put their efforts into opposing Bush, instead of having to spend millions to oppose Nader. Not that they would have, but theoretically they could have.
The FDA isn't feeling any heat. Only an arrogant, selfish, airhead like Nader would try to prevent them from approving drugs that kill people. The Democrats and their Republican colleagues are much too bipartisan to do anything like that.
--Mark
by
Mark E. Smith (21 articles, 29 quicklinks, 76 diaries, 972 comments)
on Thursday, January 18, 2007 at 7:15:13 AM
Maybe the FDA isn't feeling the heat and legislators' financial portfolios are always going to be more important to them than public safety. But if the legislators are aware of the public demand that the FDA be reformed or dismantled, this public dissatisfaction is not going to go away. If such dissatisfaction is not enough heat then maybe the discontent has to be larger and more in the face of the legislators through stepped up alternative media exposure. It seems only logical to be cynical about this but increasingly broad public dissatisfaction with the FDA cannot be ignored indefinitely and legislators will at some point be called to account because they will finally come to find out they have been on the wrong side of the issue all along. If something is extremely oppressive to the public, it cannot remain in place forever. That is just a basic of human existence.
by
larrybone (0 articles, 0 quicklinks, 0 diaries, 9 comments)
on Friday, January 19, 2007 at 10:45:54 AM
Conflicts of interest are always a problem, and the first step in dealing with them is to declare conflcts openly. Ms. Pringle, do you have any interests or associations with law firms that handle litigation in the area of drugs, vaccines, etc.?
by
Heraldblog (0 articles, 0 quicklinks, 0 diaries, 25 comments)
on Friday, January 19, 2007 at 7:20:09 AM
I have no hidden conflicts of interest. I clearly state at the bottom of the article that a law firm sponsored a series of litigation articles.
If the insinuation is that I somehow have the ability to instigate or influence investigations of the FDA its ridiculous. But I do have the ability to follow up on the investigations and report on their findings.
I have nothing but praise for any law firm that will take on cases from American citizens who would not stand a chance of going up against the corrupt pharmaceuticl industry if left on their own.
If the mainstream press was not bought off by industry advertising dollars, which amounts to the same as bribes or blackmail to not publish studies, reports or warnings on pharmaceutical industry, and was doing its job of adequately warning the public about dangerous products and our corrupt regulatory agencies, a journalist like me would not have to find alternative ways to educate the public.
Cheers,
Evie
by
Evelyn Pringle (188 articles, 0 quicklinks, 0 diaries, 10 comments)
on Friday, January 19, 2007 at 10:40:39 AM
