Patients Deserve More Information On Potentially Faulty Devices – Maisel
A leading expert on medical device safety wants Congress to compel FDA and manufacturers to provide more consumer protections for patients with implanted devices.
"The welfare of medical device recipients must become a higher priority for the FDA and manufacturers, and it is increasingly apparent that such a change will require Congressional action," William Maisel, M.D., argues in an editorial in the March 6 New England Journal of Medicine.
Maisel is the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and a faculty member at Harvard Medical School. He has published several studies on device safety and physicians' responses to FDA recalls. Maisel is also a past chairman of FDA's Circulatory System Devices advisory panel and currently serves on CMS' Medicare Evidence Development and Coverage Advisory Committee.
"Remarkably, we have consumer protections for airline passengers, cable-television customers, and cellular-telephone users, but few for patients who receive life-sustaining medical devices," Maisel observes. "Only with well-defined, specific consumer protections for such patients can we hope to minimize adverse health consequences and avoid costly recalls."
"Meanwhile, manufacturers have an inherent financial conflict of interest when addressing device-safety issues and have stronger legal obligations to their shareholders than to the patients who use their products. This imbalance must be corrected."
In 2006, Maisel played a key role in the development of guidelines on safety alerts for implantable defibrillators and pacemakers. The effort was led by the Heart Rhythm Society and FDA with input from manufacturers, physicians and patient advocates (1"The Gray Sheet" Oct. 2, 2006, p. 3).
However, despite that landmark collaboration, the issue of implant safety "has not gone away and it's not going to go away," Maisel told "The Gray Sheet" in a March 4 interview. Therefore, the same type of stakeholder cooperation that led to the creation of the 2006 guidelines on pacemaker and ICD recalls needs to be applied at "the higher level" - for all implanted devices.
"Real World" Informed Consent Policy
FDA regulations protect patients enrolled in clinical studies, but there is no equivalent protection for patients receiving devices outside of clinical trials, Maisel observes in the editorial.
Outside of clinical trials, "that process of balanced and informed consent doesn't take place as well as it might," he told "The Gray Sheet."
FDA should have a formal informed consent policy for device implants outside of clinical trials comparable to the agency's human subject protection rules that govern clinical investigations, Maisel said.
He also argues that the patient's point of view is not adequately represented in the FDA premarket approval process or its deliberations with manufacturers about postmarket monitoring. Therefore, there is "a failure, at times, to have a balanced review," Maisel said.
FDA could balance manufacturers' and patients' interests by ensuring that every approved device is evaluated by a reviewer specifically tasked with advocating patients' interests, he told "The Gray Sheet." The agency could also open a Consumer Protection Office, Maisel suggested.
Patients Should Be Allowed To Choose - Maisel
"Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure," Maisel says in the NEJM editorial. He alleges that, in addition to Medtronic, St. Jude and Guidant (now part of Boston Scientific) "have knowingly marketed potentially defective arrhythmia devices unbeknownst to the public."
He also cites the House Energy and Commerce Committee's inquiry into why Johnson & Johnson/Cordis was permitted to continue selling its Cypher drug-eluting stents and other vascular devices after it received a warning letter in 2004 citing manufacturing quality violations at six facilities making the devices (2"The Gray Sheet" Aug. 20, 2007, p. 3).
Often, a company will continue marketing "a flawed product" while FDA reviews the firm's amended product design and manufacturing plan intended to fix the problem, he explains in the editorial.
"Field actions can take many months, even after a company knows about the issue. That delay troubles me," Maisel said in the interview. He argues that FDA and manufacturers should be required to disclose when FDA is reviewing a manufacturer's application to change an approved device.
Maisel acknowledges that no device is ever going to be 100% flawless and that companies should be rewarded for identifying and correcting problems. But even if the risk is small, patients have the right to know about any potential malfunctions or problems that are known to FDA or the manufacturer, he maintains.
For example, in March 2007, Medtronic notified physicians of "a limited number" of doctors who had reported a higher-than-expected rate of fractures with the company's Sprint Fidelis implantable defibrillator lead (3"The Gray Sheet" Oct. 22, 2007, p. 3).
At the time, Medtronic maintained the fracture rate was "in line with other Medtronic leads" because a 100-patient postmarket study showed that the fracture rate was 1.1%. Maisel says in the editorial that the postmarket study was "grossly underpowered to detect even a moderate fracture rate in the Fidelis as compared with its predecessors."
In May 2007, Medtronic submitted an application to FDA to modify Fidelis to reduce the fracture risk. Even after the modification was approved two months later, the older version of the device remained in hospital inventories and continued to be implanted.
The company pulled the devices from hospital shelves in October 2007 when a review of 25,000 patients showed the 30-month fracture rate of the pre-modification Sprint Fidelis was 2.3%.
Maisel speculates that some of the patients who received a Sprint Fidelis lead between the first warning of a problem in March 2007 and the recall in October probably would have chosen not to have the lead implanted if they had known about the alert sent to physicians or Medtronic's plans to modify the device.
"Our culture is about self-determination ... and deciding for oneself," Maisel said in the interview. Unfortunately, "the system right now doesn't allow for patients who want more information."
A recent editorial in the Wall Street Journal quotes Medtronic CEO Bill Hawkins asserting "that society's tolerance for any risks associated with medical technology is nearing zero."
Maisel counters Hawkins' contention in the NEJM editorial. "Society is not intolerant of all risk - just unnecessary, undisclosed and preventable risk."
Maisel also disputes the Journal's claim that the biggest danger with many device recalls is that the public will "overreact" to a safety alert and that "politicians and trial lawyers" are putting patients at greater risk by pushing for product withdrawals in response to even modest health risks.
"But isn't that exactly the point," Maisel retorts. "That when given information about reliability, some patients will choose not to have the device implanted?"
"The solution is to educate patients, inform them about benefits and risks, and allow them to make their decision in consultation with their physician and family - a process called informed consent," he argues. "The failure to publicly disclose adverse event information about device safety subverts this process."
Physicians must also take on greater responsibility for informing their patients about emerging device safety issues. Maisel advocates compelling manufacturers to reimburse physicians for the time they spend with a patient discussing a device that is subject to recall, even if the company determines that no action is medically necessary at that time.
CMS is considering shifting the costs of physician visits related to product recalls from Medicare to manufacturers (4"The Gray Sheet" May 28, 2007, p. 13).
Doctors should also be forthcoming with their patients about any financial ties to device manufacturers or other conflicts of interests, Maisel noted.
- Reed Miller (re.miller@elsevier.com)
