Full article reprinted from "The Gray Sheet" - December 1, 2008
Find out how Harvard cardiologist William Maisel has been an important moderating voice during some of the device industry's most controversial moments in recent years.
Full article reprinted from "The Gray Sheet" - December 1, 2008
"For several years, I have felt that there was a need for some organization that would provide the public or consumers with unbiased, industry-independent, easily understandable information about medical devices," Maisel said in a Nov. 20 interview with "The Gray Sheet."
He quietly founded the Medical Device Safety Institute last year at Beth Israel Deaconess Medical Center in Boston where he is an electrophysiologist. Since that time, he and colleagues have conducted several studies and are raising money with the hopes of becoming a resource for confused patients and providers.
"These issues are never black and white. There are only shades of gray," Maisel explained. "[But] the way FDA and industry treat them is black and white. Rarely do we hear anything about it and then you cross some threshold and suddenly it becomes a recall. And then what happens is rumors start flying ... and patients and physicians hear about these things and they are kind of left in the dark [about] what they should do.
"I envision our organization trying to fill some of that vacuum."
ICD, Stent Issues Pointed To Bigger Problem
Maisel played a lead role in the 2005-2006 collaboration between doctors, device makers and FDA in creating guidelines on safety alerts to patients and doctors for implantable defibrillators and pacemakers. The guidelines were deemed necessary after manufacturers, most prominently Guidant, were criticized for being too slow and ambiguous in alerting the public to malfunction risks (1"The Gray Sheet" Oct. 2, 2006, p. 3).
Since then, Maisel says he has realized that that effort was just the tip of the iceberg. He believes the entire industry and device regulators should be doing more to get understandable product risk information to patients and doctors sooner.
The critical importance of risk communication was underlined in 2006 with the release of data suggesting drug-eluting stents posed a higher risk for late-stent thrombosis than bare-metal stents.
Maisel chaired an FDA panel meeting to discuss drug-eluting stent safety in December of 2006. The panelists ultimately agreed drug-eluting stents were safe for their labeled indications, but called for substantial data collection for other indications (2"The Gray Sheet" Dec. 11, 2006, p. 5).
The panel meeting was "useful," Maisel said. "But it was slow going. And even when that was all completed, it was basically up to the media to decipher what happened and inform the public about it."
"There were millions of patients who had these stents in place but were not getting a straight answer." Maisel's safety institute is "interested in providing accurate information and trying to direct it towards the consumer," he said.
Institute Aspires To Be Data Source, Watchdog
The institute will collect data and publicly communicate results on areas where Maisel and his colleagues believe industry is not putting enough emphasis.
The institute has already conducted and publicized results of three studies since its founding. The first, published in January in the American Journal of Therapeutics, tracked off-label use of biliary stents to treat peripheral vascular disease from 2003 to 2006, concluding that such off-label use was increasing and that most biliary stent adverse events resulted from the off-label application.
This is an area where CDRH was already focused in pursuing manufacturers for off-label marketing. But since Maisel's report, which was covered by the New York Times, the Department of Justice has initiated investigations on this issue (3"The Gray Sheet" Aug. 4, 2008, In Brief).
Maisel does not claim that the institute's study caused the investigation or any other specific developments, but he suggests it is an example of being part of a "groundswell of activity that moves the field in the right direction."
The other two studies reported by institute scientists investigated the potential for wireless interference, either intentional or not, with pacemakers or implantable cardioverter defibrillators.
In one analysis, widely reported in March, the researchers demonstrated that they could wirelessly reprogram an ICD to disable the defibrillator or to deliver an unnecessary shock without authorization. They also were able to retrieve personal patient information from the device (4"The Gray Sheet" March 24, 2008, p. 5).
Last month at the American Heart Association meeting in New Orleans, Maisel and colleagues reported that magnets contained in headphones commonly used with portable digital music players like the iPod can interfere with pacemaker and ICD functioning if placed within an inch of the device.
Beyond its own studies, the institute also hopes to evolve into a device safety data watchdog group, "where we decipher some of the information already out there and try to issue observations, based on fact, based on data, based on evidence, to help out patients and physicians in areas where there may be controversy," Maisel said.
Mission Goes Beyond Cardiac, Includes Advocacy
The next steps for the organization will partially depend on funding, the cardiologist acknowledges. The institute gets its support from philanthropic donations and non-industry grants, Maisel explains.
He says the institute's leadership plans to expand activity beyond cardiology devices, which have been the focus so far. "I think it will be across the board.... We are sort of walking before we run."
Another function for the institute as stated on its Web site (www.medicaldevicesafety.org) is to "advocate for policies that improve medical device safety."
Since the founding of the group, Maisel has been very public and direct about his views, ruffling feathers in industry and at CDRH in the process.
He published a critical editorial in the New England Journal of Medicine in March calling on FDA and manufacturers to make the welfare of medical device recipients a higher priority and for Congress to increase consumer protections for patients with implanted devices (6"The Gray Sheet" March 10, 2008, p. 3).
In May, he testified before the House Committee on Oversight and Government Reform on the need for "additional consumer safeguards" beyond initial FDA device approval. The hearing was called by Rep. Henry Waxman, D-Calif., to question the practice of FDA pre-emption of state liability lawsuits.
Despite these critiques, Maisel stresses that he has no qualms with how companies are developing new technology and does not want to use the institute to impede new products' path to the market. His focus instead is on how well firms prepare for inevitable post-market problems.
"For me, the issue is not about 'safe or unsafe,' the issue is about communication and handling of information received about adverse events and device malfunctions."
Referring to the high fracture rates associated with Medtronic's Sprint Fidelis ICD leads that caused the firm to pull the product off the market last year, Maisel said, "It is not surprising that one company's defibrillator lead might have a higher fracture rate. Those things are going to happen and that is inevitable.
"The issue is how careful we are looking for these things or how well we predict where the trouble might arise.... When you are putting a potentially life-sustaining product out to hundreds of thousands of people in the case of a lead or millions in the case of the stent, it is predictable that you are going to want to know how the device is performing. I just think we need to do a better job of anticipating which products are going to need better data collected."
- David Filmore
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