April 24, 2013 By Steven E. Greer, MD
In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff’s lawyer, Stephen Kohn.
One month later, a senior FDA official who was named as a defendant in the lawsuit above, William Maisel, MD, PhD (a former Harvard cardiologist), was a arrested in a Maryland suburb on five counts relating to soliciting a prostitute. The story was not reported well in the national press and the fate of Dr. Maisel at the FDA had been unknown.
On April 23rd, 2013, the FDA issued an email announcement from Dr. Maisel, still employed at the agency, about an upcoming conference call on medical devices. We asked the FDA for a comment, whether he was disciplined for his arrest, etc. The FDA replied, “As you may know, we have a long-standing policy of not discussing personal or personnel matters. Dr. Maisel is still employed by FDA.”
We investigated the Maryland criminal court records and learned that Dr. Maisel pleaded guilty to one of the prostitution charges, received a $200 fine, and agreed to probation. The other charges were dropped.
The FDA’s medical device division, CDRH, has long been plagued by industry bias and corruption. In 2009, the CDRH Director under President Bush, Daniel Schultz, was forced to resign after numerous allegations that he ignored the recommendations of FDA medical officers and approved devices against their recommendations. Jeffrey Shuren, MD, the new leader of CDRH, initially tried to implement tough standards for medical device testing. After industry lobbyist pushback and strong congressional support for the medical device industry, he quickly made a 180 degree turn and loosened approval standards by allowing many devices to still be approved under the 510K pathway without clinical trials.
It was under Dr. Shuren that Dr. Maisel was hired from Harvard. At Beth Israel in Boston, Dr. Maisel had formed a medical device industry watchdog institute in response to the numerous recalls and safety problems related to ICDs. After receiving the cushy government job at the FDA, Dr. Maisel softened his tone and has made no public attempt to improve the MAUDE database or require clinical trials for implanted medical devices, such as orthopedic implants.