Friday, January 9, 2009
FDA scientists complain again
I have been arguing for years that the FDA is a troubled agency with very little credibility to say the least. Today, the Chicago Daily Law Bulletin reports of another statement by FDA scientists alerting of problems within the agency. For a report on the previous one see here. The CDLB article states: "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, on the letterhead of the agency's Center for Devices and Radiological Health. 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. 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 within the agency." The PopTort Blog has a comment on this topic here.