Healthy Skepticism Library item: 2444

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Publication type: news

Regulating a Faulty Heart Device
New York Times 2005 Sep 13
http://www.nytimes.com/glogin?URI=http://www.nytimes.com/2005/09/13/opinion/13tue2.html&OQ=nQ3DTopQ252FOpinionQ252FEditorialsQ2520andQ2520Op-EdQ252FEditorials&OP=2af836d3Q2FQ255ulQ25gjUTQ5Djj8Q7CQ25Q7Ccc)Q25c2Q25Q3EQ2AQ25jQ5EQ7BQ3FQ7BjQ3FQ25Q3EQ2A8,uQ7CqQ518GY

Keywords:
Guidant defibrillator FDA

Notes:

Ralph Faggotter’s Comments: This article provides further evidence of the FDA’s tendency to favour industry over public safety.

Full text:

Regulating a Faulty Heart Device – New York Times

September 13, 2005
Regulating a Faulty Heart Device
The deplorable story of how a medical-device company sat on information about a
flawed heart defibrillator while a hapless recipient died has now engulfed the
Food and Drug Administration as complicit in the silence. A report by Barry
Meier in The Times yesterday revealed that the agency received a report from the
manufacturer detailing the flaws months before the F.D.A. issued a safety alert
on the devices. By the time the agency acted, a college student relying on the
implanted defibrillator to shock any erratic heart beats back to normal had died
while mountain biking. His unit had short-circuited, just as the same model did
earlier in about two dozen other patients.
What is disturbing is how long it took the company, the Guidant Corporation, and
the regulators to get a meaningful warning to doctors and patients. The company
is required to submit an annual report to the F.D.A. that includes data on how
often, and why, its devices fail. As it turned out, the company waited until
mid-February of this year to submit a report that covered the year from June 1,
2003, to May 31, 2004. The eight-month lag seems intolerably long for devices
that can mean life or death. In previous years, Guidant had submitted reports
within three months of the period covered.
The report revealed that 10 of the problematic devices suffered short circuits
during the year. This was surely information of potentially great importance to
doctors and patients. The student mountain biker died in March. Neither he nor
his doctors were aware of the short-circuiting problem.
The regulators also appeared lethargic. The F.D.A. has a policy of reviewing the
annual reports within 90 days, but it is unclear whether the regulators read
Guidant’s report by mid-May. There is no indication that the agency took any
action in response to it. Only when The Times was about to publish an article on
the flawed devices in late May did the company issue an alert to doctors,
followed in June by an alert from the F.D.A.
The agency’s excuse for not making the failure data public right away is too
feeble to withstand scrutiny. Although F.D.A. officials have sometimes claimed
that the annual reports are proprietary documents that must be kept
confidential, they now acknowledge that the failure data itself is not
confidential. The problem, they say, is that the failure data is included in a
report that contains other proprietary information. It would be an inefficient
use of time and resources, the agency says, to plow through hundreds of annual
filings to determine what information could be released and what had to be kept
confidential.
If that is the only problem, the solution is simple: require the companies to
submit the failure data separately in a form that can be released immediately.