TUESDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug
Administration (FDA) is not doing its job of properly monitoring
the safety of medical devices, the authors of a new report
The FDA has the authority to approve both drugs and medical
devices, but the investigators believe that the division
responsible for device approval and safety is lax in both its
initial approval of devices and its ongoing monitoring of related
"The agency often misses problematic devices," contends lead author Shannon Brownlee, an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.
The report is published in the Nov. 3 online edition of the
In their article, Brownlee and New York-based medical
investigative journalist Jeanne Lenzer focus on the FDA's approval
and follow-up of a device that prevents or reduces seizures in
patients with epilepsy who don't respond to drug treatment.
This apparatus, called a vagus nerve stimulator (VNS) is made by
Texas-based Cyberonics. The VNS, which is implanted under the skin,
works by sending electrical impulses to stimulate the vagus nerve
in the neck.
The FDA approved the device in 1997 and some 60,000 patients
around the world are using it, according to the manufacturer. In
2005, the FDA also okayed the device as a treatment for
medication-resistant depression. There are some 5,000 people who
use VNS to treat depression, Cyberonics says.
Brownlee and Lenzer's concern: That during the 13 years the
device has been on the market there have been 900 FDA-reported
deaths of people using the device to control their epilepsy.
The question of whether any of these deaths were due to the
device remains unanswered, however, even though Cyberonics did
conduct the post-marketing study the FDA requested at the time of
approval. However, the FDA did
not require the study to report the cause of death for
individuals using the device, Brownlee and Lenzer said.
FDA spokeswoman Karen Riley said the agency is engaged in an
ongoing effort to improve overall medical device safety monitoring.
"We have an initiative underway to strengthen post-market
monitoring," she said.
But Brownlee believes the story of the VNS device to be just one
example of the FDA's failure to monitor the safety of medical
devices before and after they are out in the marketplace. For
example, she pointed out that less than one-third of devices
approved under FDA's pre-market approval process had ever been
evaluated in a randomized trial.
And she said that it was physicians, not the FDA, who spotted
serious problems with certain implanted defibrillators, for
example. "It was physicians keeping their own database that alerted
the company to the problem," Brownlee said.
Moreover, she believes the agency is not capable of detecting
potentially unsafe devices through its own harms database. Brownlee
cited a finding that many post-approval studies are either not
done, or conducted so poorly "as to be meaningless."
According to the
BMJ, the FDA referred Brownlee and Lenzer to five post-approval studies that they said established the device's safety. However, Brownlee said these studies do not prove the device was not the cause of deaths, since none contained mortality data.
Brownlee also said that when the device was approved for
depression it was over the objection of FDA's own panel of
scientists. And, according to Brownlee, the company has suggested
that VNS may be useful for a wide range of other ailments,
including obesity, stroke and traumatic brain injury, and has
patented the device for these potential therapies.
According to Brownlee, the FDA will only improve when it gets
more staff, better funding, more authority and more outside experts
to objectively evaluate device safety.
The new findings come on the heels of a recent embarrassment for
the agency: In October, the FDA apologized for mistakenly approving
the Menaflex knee implant over objections from its own scientists.
In its announcement, the FDA admitted it caved to political
pressure from New Jersey senators and a congressman. The FDA has
now taken steps to rescind that approval.
"I have sympathy for the FDA, which is understaffed and underfunded in many areas," Brownlee said. "But there is no question that this agency had been captured by the very industries that it is supposed to regulate," she said.
Defending the VNS, Cyberonics chief financial officer Greg
Browne said that "none of the approximately 900 deaths reported to
the FDA were attributed to VNS therapy."
"Available data demonstrate that all-cause mortality rates for VNS therapy patients are less than half the rates in the comparable non-VNS epilepsy patient population," he added.
Dr. Jerry Avorn, professor of medicine at Harvard Medical School
and author of an accompanying journal editorial, agreed with the
article's authors that, "until recently the part of FDA that
approves devices has been run in a much more loose manner than the
part of FDA that approves drugs."
While the FDA has started to deal with some of these problems,
"it's still more of a wild west environment than the drug side of
FDA," he added.
The agency needs to look harder at the standards it uses when
approving new devices, and should revamp its surveillance systems
to spot people who have received faulty devices, he added.
"All government regulation is not a bad thing," Avorn said. "It can sometime be life-saving," he said.
For more information on the FDA and medical devices, visit the
U.S. Food and Drug Administration.
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