Medical Devices & FDA Approval: FDA Scientists Report Widespread Corruption
Federal scientists issued a complaint to the Obama transition team about widespread managerial misconduct within the Food and Drug Administration. This letter was actually on the FDA’s Center for Devices and Radiological Health letterhead; this Center is responsible for medical devices that range from breast implants, to imaging machinery, to MRI’s to heart stents. A copy of the letter, with redacted scientists’ names, was provided to the Associated Press by a Congressional official. It reads:
The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been distorted and corrupted by the current FDA managers, which places the American people at risk. These managers have incompatible, irrelevant and discordant scientific and clinical expertise in devices and have ignored serious safety and effectiveness concerns of other FDA experts. Managers have also ordered, coerced and intimidated FDA experts to modify scientific evaluations, recommendations and conclusions that are in violation of laws, rules and regulations; they have also accepted clinical and technical data that is not scientifically sounds. Currently, there is an atmosphere of fear at the FDA where honest employees fear dishonest employees—not the other way around.
These concerns from the nine scientists who wrote the transition team echo similar complaints to those or the FDA’s drug review division a few years ago, during the safety situation involving the painkiller known as Vioxx. So far, the FDA has not publicly responded to the letter, but the agency did say they were working to address the concerns. In their letter, the FDA insiders alleged that the agency managers used intimidation in order to stop scientific debate, which led to the approval of medical devices with questionable effectiveness and safety.
This letter has to be taken seriously by the Obama Administration, because it is a shocking indictment of an agency whose duty it is to protect Americans when it comes to safety and health issues. Senior Republican and Democratic lawmakers are urging the President to appoint an FDA commissioner who will shake up the agency and restore the confidence of its medical experts and working-level scientists. These scientists had previously taken their concerns to Congress, finding support from House members. In the letter, the group singled out mammography computer-aided detection devices as a prime example of a technology that should have never gone forward. These devices were supposed to improve breast cancer detection, but studies instead showed that they were linked to false alarms that eventually led to unnecessary breast biopsies.
It was also pointed out in this letter that since 2006, FDA experts have recommended 5 times against approving devices without receiving better clinical evidence. In March of last year, an outside panel of advisers supported some of the concerns of the FDA’s in-house scientists; nevertheless, FDA managers overruled these objections and ordered approval. The letter said that top FDA managers committed the most outrageous misconduct by ordering, coercing and intimidating agency physicians and scientists to recommend approval, and then retaliating when these same physicians and scientists would not go along. The Obama Administration and Congress simply cannot ignore these warnings from inside the FDA; the agency must be repaired and restored to its public duty.