Isn’t it interesting that a group of federal scientists are complaining to the Obama transition team of widespread leadership misconduct, in a division of the Food and Drug Administration.
The purpose of this complaint was to inform them that the scientific review process for medical devices at the FDA has been altered and misrepresented by current FDA managers, thereby placing the American people at risk.
The center is responsible for medical devices ranging from stents and breast implants to MRI’s and other imaging equipment. The concerns of the nine scientists who wrote to the transition team repeat 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.
The FDA dissidents indicated that agency managers use intimidation to inhibit scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which possibly 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. 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 notice, 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 said in response that 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 this report the group picked out mammography computer-aided detection devices as an example of a technology that should not have continued. The devices were supposed to improve breast cancer discovery, but instead studies show they were connected with false alarms that led to excessive and 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. Even so the 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.
Has it reached where the BUCK stops? Can we look for more progress in this area? One way to get rid of rats is to exterminate them. We can only hope. 12 to 20 years ago we have had the most corrupt people in our highest offices. This is where the problem needs to be addressed and weed out that kind of corruption. If the head is sick, then the whole body suffers.
Have you ever been attacked by a mad hornet, or a nest of them? That’s how I feel about this situation, mad as hell. Our leadership has a stench that reaches into the heavens. However as I have been researching the various products of TriVita I am finding that there are some good things happening in the field of alternative health care and is headed for confrontation with such activity that is going on in the FDA. All I can say is right at this time you can’t trust anything that is coming out of the FDA. Beware!
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