Beth Israel cardiologist to head new Science Council at CDRH

Dr. William Maisel, a cardiologist at Boston’s Beth Israel Deaconess Medical Center, will chair the Center for Devices and Radiological Health’s new Center Science Council according to CDRH director Dr. Jeff Shuren.

The new Council will guide the agency in science based decision making.

The announcement was made earlier today in a conference call scheduled to discuss proposed changes to the Food & Drug Administrations’ 510(k) approval process.

Shuren said during the call that this group will serve as a "standing body," responsible for overseeing science-based decision making across CDRH, provide regular audits decisions made by the agency and assess program performance.

Maisel, an associate professor at Harvard Medical School, also serves as the founder and director of the Medical Device Safety Institute at BIDMC and is well known in FDA circles.

Dr. Maisel has been publicly very critical of the FDA and CDRH recently, even though he has consulted for the agency and is a former member of it Circulatory System Medical Device Advisory Panel.

At the annual Heart Rhythm Society conference in May 2009 where Maisel chaired a panel on defibrillator leads, Maisel told the Wall Street Journal that “All the stakeholders agree that we need to do a better job.”

“There needs to be formal post-market surveillance for every model of lead," he said, "not just waiting for something to happen, but to actively provide surveillance for every model.”

The Heart Rhythm Society, which issued heart lead recommendations at the conference, said manufacturers and the Food & Drug Administration need to cooperate in creating a post-market surveillance program for the devices.

Maisel co-authored an article published in the Journal of the American Medical Association based on an FDA-sponsored study that looked at the scientific quality of the clinical trials submitted to the FDA between 2000 and 2007.

The researchers found "that submitted studies frequently lack important details, including information about subjects and study end point definitions."

“It is important that the FDA and manufacturers do things differently,’’ Maisel told the New York Times when commenting on the article.

In June 2009 medical professionals went to Washington and told Congress that the FDA’s medical device approval process should be beefed up to better protect consumers, and Maisel was among them.

Medical experts ranging from physicians to the health Government Accounting Office spoke during the Congressional hearings, according to news reports.

Medical device monolith Medtronic Inc. came under especially intense scrutiny at the hearing, due to the recall of 21,000 of its Kappa and Sigma series implantable pacemakers (Medtronic estimates more than 1.7 million have been implanted in patients worldwide) and the death of at least 18 patients after its now-recalled Sprint Fidelis defibrillator leads fractured.

Maisel, said such recalls raise questions about the FDA’s ability to swiftly identify safety problems.

“Additional consumer safeguards are needed. Only by demanding more thorough, scientific device evaluations can the FDA hope to reestablish consumer confidence in its ability to protect the public’s health,” Maisel told the Congressional panel, adding that the agency is too reliant on the device industry’s ability to police itself.

Overall, Maisel seems driven by patient safety.

Maisel and Tadayoshi Kohno of the University of Washington in Seattle, compared the current state of medical device security to the pharmaceutical supply chain in the early ’80s in the April 2 issue of the New England Journal of Medicine. Citing the 1982 cyanide poisoning of Tylenol, which killed seven people, Maisel and Kohno wrote that medical devices "like the drug supply of a generation ago, face a security vulnerability that must be addressed through regulatory and scientific actions."

"We think medical device security should be improved before there is a widespread incident, rather than waiting for the incident to occur and then acting," Maisel wrote in an e-mail to MedPage Today. "It is very difficult to add on security after the fact."

Maisel also appears to be a pragmatist in his view of healthcare policy.

“The medical community drives care in the direction of beneficial treatment," Maisel said last April. “There is an unrealistic expectation of Americans in general that they are entitled to every therapy, regardless of how expensive it is,” he adds. “That just isn’t realistic. It wasn’t realistic before the economic downturn, and it isn’t now.” Maisel did not believe that British-style rationing of care in the U.S. is very unlikely to occur, even in the face of a worsening economy.

Commenting on the $1 billion from the American Recovery and Reinvestment Act is earmarked for comparative effectiveness research, Maisel said “I think there is an opportunity to improve patient care and improve patient cost. That’s why I think the stimulus bill is so important,” Maisel said, adding that research results could begin to emerge within 18 to 36 months.

“The device product life cycle is very short and I think, with the research money getting out there very quickly, we could see studies develop very soon,” he said.