FDA Slammed Over Heart Device TrialsDec 30, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) has been criticized by two prominent medical journals over how it approves cardiovascular medical devices, says the Wall Street Journal. The journals accused the FDA of releasing some devices to market based on inadequate test results that are “open to bias,” said the Journal.
The Journal of the American Medical Association (JAMA) said many of these devices receive approval to release after jut one study, said the Journal, which noted that medications generally undergo a variety of tests. Although cardiac devices do receive the strictest of FDA review processes, the study published in JAMA points out that these processes are not as stringent as drug review standards, said the Journal. "The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can," the researchers said, quoted the Journal.
The other study, which appears in the American Journal of Therapeutics, had, as one of its authors, a medical reviewer from the agency’s cardiovascular device division, said the Journal. In that study, the researchers found that studies presented to obtain cardiovascular device approval "frequently lack important details," said the Journal, citing the paper. One such important detail was found to be who conducts research, added the Journal.
We recently wrote that even though medical device recalls have increased in recent years, the FDA has not devised an effective process for notifying the public about dangerous devices. According to an earlier Associated Press (AP) report, lack of such a process has put patients in danger. For instance, in 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, of those, 100 were deemed Class I, the FDA’s most serious recall, which is issued when there is a “reasonable probability of adverse health consequences or death.” Finding these recalled devices is no easy task, particularly after they have been implanted into someone’s body, such as in cardiovascular devices.
Acting FDA device division director Jeffrey Shuren admitted to cardiovascular clinical trial issues, reported the Journal.
Both studies involved researchers reviewing some 80 cardiovascular devices approved from 2000 through 2007 said the Journal. JAMA looked at University of California, San Francisco research that reviewed public FDA summaries of device safety and efficacy, said the Journal. William Maisel from Boston’s Beth Israel Deaconess Medical Center and who was a part of the study discussed in the American Journal of Therapeutics, said data unreliability was critical to “why we have been pushing the FDA to raise its clinical trial standards for medical devices," quoted the Journal.
We have written that many patients implanted with heart devices are not aware of recent recalls of the implantable devices and do not understand the dangers they might face. Recent recalls of implanted defibrillators have forced some patients to have them removed. In some, malfunctions led to additional cardiac procedures or complications and even death.
A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When the wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition in which pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.