Patients must also be smart consumers
Published in Jim Bracher's Integrity
Matters newspaper column on June 22, 2005
How can Guidant Health Systems remain in business while
delivering pacemakers that kill people? What can I do
to make sure I don't die because of a faulty product?
Guidant has a history of irresponsible leadership and
inconsistent product quality. This column addressed their
malfeasance in July, 2003 when I wrote: Greed,
whether for power or money (or both), is at the heart
of this problem. Compromising health and life cannot
be tolerated. Fortunately, such reckless endangerment
seems to be the exception. Most manufacturers and, especially
the ones associated with health care, test and monitor
each product to guarantee both quality and safety. Our
society safeguards us with many agencies responsible
for testing products that affect our lives. Organizations
that we have created and support test, on our behalf,
what we drive, wear, eat and utilize in all aspects of
our lives, specifically in areas related to health care.
These processes are overwhelmingly effective.
Problems with Guidant's popular heart defibrillator
have led federal regulators to start an inquiry into
whether the company violated a corporate integrity agreement
it signed in 2003. Indianapolis-based Guidant had signed
the integrity agreement after a former Guidant, subsidiary,
Endovascular Technologies Inc., pleaded guilty to 10
felonies and paid $92.4 million to settle criminal and
civil charges in a case involving a device meant to treat
abdominal aortic aneurysms. The Justice Department contended
that Guidant covered up thousands of Ancure incidents
in which the delivery system of the device had malfunctioned,
including 12 deaths.
More recently, Guidant reported yet another malfunction
to the Food and Drug Administration, but it did not inform
patients and doctors for three years until physicians
at Abbott Northwestern Hospital in Minneapolis, publicly
questioned the company's conduct. Guidant maintains that
the device is highly reliable. Under federal law, a company
must report any incident to the FDA in which its medical
device might have caused or contributed to a death or
serious injury, or if the malfunction is likely to recur.
Guidant's reputation erodes confidence in the integrity
of health care. This cannot be allowed.
So, before accepting potentially-risky health treatment
- Ask questions. Get second opinions.
- Demand current information that confirms the quality
and reliability of any treatments, including technologies,
- Utilize this toll-free hotline: 888-463-6332; which
will connect you with the Food and Drug Administration.
The FDA can also be reached online at: http://www.fda.gov/comments.html.
The FDA addresses many concerns about technology, toxicology
and health safety.
- Research current news regarding issues related to
medical devices and radiological health. Learn what
products and services are working well and which ones
are causing problems: http://www.fda.gov/cdrh/consumer/
Forward additional health hotline suggestions directly
to us - (email@example.com
- so that we might pass along helpful resources and strengthen
the integrity of health care delivery. Restoring
confidence in health care's integrity is a must.
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