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Whistleblowers and the F.D.A.

The U.S. Food and Drug Administration oversees everything from cosmetic labeling to vaccination purity and efficiency.  Included in the F.D.A.’s purview is the research and approval of medical devices, like vaginal mesh, the subject of this week’s story. At issue is the process by which many medical devices, based on similar products already on the market, are cleared for use. Critics say that the process isn’t rigorous enough. Proponents say that adding levels of scrutiny will slow down much-needed medical devices getting to those who need them.

In recent years there has been discord within the F.D.A. over device review process, leading to allegations of whistleblower intimidation. In 2012, a group of agency scientists alleged the agency took actions against them, according to the New York Times because “of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.”

The group claimed the agency was effectively “spying” on them through a system of e-mail surveillance, beginning in 2009. The Washington Post reported that the F.D.A. warned employees of the monitoring of communications and documents sent or stored through their system. The employees alleged “the government violated their constitutional privacy rights by gazing into personal e-mail accounts for the purpose of monitoring activity that they say was lawful.” U.S. Senator Charles Grassley (R-IA) has called for an investigation into the matter.

The crux of the debate over the process was discord over the depth of research and documentation needed to adequately determine the safety of new technology. Dr. Robert Smith, the ‘crusader‘ of the scientists who charged the F.D.A. with spying, believed his work was stymied by the agency. Dr. Smith purportedly circumnavigated what he perceived to be complicated ethics issues by voicing his concerns directly  to parties outside the F.D.A. “Dr. Smith repeatedly approached lawmakers, sending out batches of late-night e-mails with huge files attached to demonstrate the F.D.A.’s dysfunction. Some Congressional staff members thought the F.D.A. might be punishing him for raising complaints. But others found his confrontational tactics so off-putting that they chose not to work with him.”

However, some say the F.D.A. is not necessarily faltering on their responsibility, but that simply a true difference of opinion between how much is “too much” regulation exists. Forbes reported that a “split between various factions, with a minority of junior scientists determined to push an ultra-aggressive regulation strategy even after higher level science reviews consider but reject their input” exists at the agency.

In the specific case about Dr. Smith, some concerned with the approvals he has blocked in his tenure at the agency find his criteria for approval prohibitive. In a study undertaken by another doctor, Etta Pisano, devices rejected by Smith were determined to be safe. Dr. Pisano told the Wall Street Journal, “He began putting in obstacles to approval that were unreasonable. Because of Dr. Smith, new machines didn’t get on the market.”

Complicating the general regulatory process further is the advent of mobile medical devices, a topic Congress has taken up just this week. A release about the hearings called them, a “Health Information Technologies” series, “to discuss the critical role of technology in the health care industry and how federal regulations and taxes could impact patients, hinder innovation, and increase costs for consumers.”

As with many government regulatory processes, the cost of keeping up with evolving technology and advances can be difficult and cost-restrictive. The Chief Medical and Chief Science Officer for West Health Institute stated in the hearing, “I think it’s quite challenging for the FDA, for many reasons, to stay as current as possible on those things which are simply just emerging.” The  dialogue around safety research and technological advances continues.