A group of federal scientists complained to the Obama transition team last month about widespread managerial misconduct in a division of the Food and Drug Administration. The letter was on the FDA’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. A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a Congressional official. The letter read:
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. 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. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
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. Thus far, the FDA has refused to publicly respond to the letter, but did say the agency was working to address the concerns. In their letter the FDA insiders 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.
This letter must be taken seriously by the Obama Administration. It’s a shocking indictment of an agency whose duty is to protect the American people on safety and health issues. Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner for the agency who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. These FDA scientists had 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.
It was pointed out in the letter that since 2006 FDA experts have recommended five times against approving the devices without better clinical evidence. 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. The letter said that 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 Obama Administration and Congress can’t ignore these warnings from inside the FDA. The agency must be repaired and made capable of doing its mandated duty to the public.
Source: Associated Press
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.