FDA Scientists to Obama: Overhaul Agency

Yesterday, 9 FDA scientists sent a letter to Obama's transition team, pleading with the President-Elect to restructure the "fundamentally broken" agency, reports today's WSJ. The scientists allege that FDA managers "ordered, intimidated and coerced" the scientists to manipulate data during product reviews, particularly within the Center for Devices and Radiological Health (CDRH). The letter's authors were not reported.

A similar letter was sent in October to the House Energy and Commerce Committee, but yesterday's correspondence is more detailed, writes the WSJ, describing allegations like the "threat of disciplinary action against scientists who dissent from management." The letter also specifies that past CDRH approvals of certain computer-aided detection devices for mammography were not supported by scientific evidence, writes the WSJ.

The following excerpts from the scientists' October letter likely indicate the nature of their complaints in yesterday's correspondence:

Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).

Managers at CDRH with no scientific or medical expertise [redacted] devices, or any clinical experience in the practice of medicine [redacted] have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements. To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law. Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects. These same managers have knowingly avoided and failed to properly document the basis of their decisions in official Agency records.

Under the banner of regulatory "precedent," managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions, that are not scientifically proven and clinically validated. 

The letter goes on to describe the scientists' complaint to FDA Commissioner Andrew von Eschenbach in May 2008, which led to an investigation with William McConagha, Assistant Commissioner for Integrity and Accountability. The investigation culminated in a September meeting among FDA scientists, representatives from the Commissioner's office, and the CDRH Director, Daniel Schultz.

The meeting prompted Schultz to conduct his own investigation of CDRH. But Schultz concluded, according to the letter, that the "FDA physicians and scientists need to 'move forward,' thus allowing managers to avoid and evade any accountability and without taking any curative or disciplinary actions whatsoever." Schultz is also alleged to have allowed the continuation of management reprisals against FDA reviewers, including threats of job loss and "illegal and improper employee performance evaluations." 

Schultz, a medical doctor, is a career FDA officer who was appointed CDRH Director in 2004. Donna-Bea Tillman, PhD, is Director of the ODE.

01/13/09 update: In yesterday's NYT, Gardiner Harris reveals that an FDA supervisor overruled FDA scientists and approved iCAD's SecondLook Digital Computer-Aided Detection System for Mammography, after receiving a phone call from former Connecticut congressman Christopher Shays. (FDA approval info here.) The device is used in conjunction with screening equipment made by Fujifilm Medical Systems, which is based in Stamford, CT, the center of Shay's former district.

Harris's article was evidently prompted by FDA documents, which were recently provided to the NYT. In e-mails, FDA scientists claimed that a supervisor forced them to change their reviews of iCAD's breast-imaging device, despite the fact that "iCAD never tested the device by the intended users (ie, radiologists) under the intended conditions of use." An FDA review indicated that the iCAD device was associated with unacceptable false-negative and false-positive rates, which resulted in missed cancers or unnecessary surgery and even radiation therapy. In response, iCAD's CEO told the paper, "We have done all the appropriate testing to get the product approved." 

For his part, Shay claimed that he called an FDA supervisor 1 year ago "only to demand that the agency make a final decision, not that it approve the product." A spokesperson for Fujifilm admitted to the NYT that the company requested local congressional support to "get clarification on the FDA process."

In his article, Harris also cites the arguably inappropriate, abbreviated FDA review of complex, novel devices at the behest of FDA managers. One such example is the FDA review of AngioCT from Shina Systems.