This Just In…
FDA Admits Failure to Protect Public
By Gabe Pressman
NBCNewYork.com
Updated 11:18 a.m. ET Jan. 13, 2009
A government watchdog has confirmed what some of us have suspected for some time.
The Food and Drug Administration has done virtually nothing to monitor the conflicts of interests of doctors who do clinical trials of drugs and medical devices used on human subjects. This is disgraceful.
The physicians who conduct these trials are supposed to help decide whether or not a drug is effective in treating people. And now the inspector general of the Health and Human Services Department has concluded the FDA is falling down on the job. Indeed, the Times reports, FDA officials have told investigators that monitoring such conflicts of interest is not worth the trouble.
Dr. Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, deplores the FDA’s failure.
“Doctors who have close financial ties to the pharmaceutical industry should not be conducting clinical trials of these drugs,†Dr. Kassirer told me. “And, if you look at the committees responsible for approving drugs, you’ll find that many have such ties.â€
Clearly, for doctors to have a financial interest in the very companies that manufacture the drugs they’re testing violates any standard of fairness or objectivity. Recently, there have been revelations of such conflicts of interest — some involving professors at major universities. Such relationships can hardly inspire public confidence in medicine.
Kassirer said many doctors have high moral standards and it is certainly possible to assemble an impartial jury of physicians for any drug test. So why, so often, do physicians with built in conflicts get selected to conduct such trials?
A spokeswoman for the FDA said that agency opposed scrutinizing doctors’ financial conflicts before trials because they represented just one possible source of bias. Does that mean there have to be at least two sources of bias before the government decides to protect us? On the face of it, that seems ridiculous.
The Obama administration should take a hard look at the ethics of the government agencies and doctors who test drugs for us.
January 14th, 2009 at 10:26 am
Well, I am not entirely surprised.. Then again, because of what I do for a living, I am fairly close to things…(and sometimes have a slightly different view on things due to that too).
I really cannot take the stance that ‘The FDA’ as a whole are the bad guys. I know many FDA reviewers (the guys and gals in the trenches) personally, and they are by and large good people that want to do their job and that take their responsibilities very VERY seriously.
BUT, there are a lot of rotten apples at the top. Political appointees, career government people that forgot a long time ago WHY exactly they joined The Agency, etc. etc.
Here’s another article that may give some perspective. Folks in the FDA trenches ARE speaking up.. but they are being shut down by their management.
[and for full disclosure. I feel exactly the same way about the average Joe or Jane at the CDC or at the NIH. I know folks there too, who would never purposely do ANYTHING that could harm another person..]
Last updated January 8, 2009 3:22 p.m. PT
FDA scientists complain to Obama of ‘corruption’
By RICARDO ALONSO-ZALDIVAR
ASSOCIATED PRESS WRITER WASHINGTON —
In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration. “The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead. The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery.
The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx. The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”
A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official. “Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.
FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”
Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes – which is the agency’s reputation. The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House. In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies. Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval. Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.
A spokeswoman said the Obama transition team had no comment.