June 22, 2005
Patients must also be smart consumers
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
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 U.S. 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 U.S. 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 contends
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,
here are some recommendations:
- Ask questions. Get second opinions.
- Demand current information that confirms the quality
and reliability of any treatments, including technologies,
- Utilize this toll-free hot line, (888) 463-6332,
which will connect you with the FDA. The FDA also can
be reached online at www.fda.gov/comments.html,
where the agency 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: www.fda.gov/cdrh/consumer/
Forward additional health hotline suggestions directly
to us at email@example.com so we might pass along
helpful resources and strengthen the integrity of health-care
delivery. Restoring confidence in health care's integrity
is a must.
Letter to the Editor, published November 8,
When the Tylenol scare occurred years back, McNeil
Labs stepped up, admitted the problem, pulled the product
off the shelf and quickly communicated with customers.
The result was that Tylenol customers continued to
hold the company in high esteem and sales increased rather
This process was based on responsible management with
a high regard for its customers as well as its own profitabilsity.
This proved that integrity matters.
I happened to see the June 22 "Integrity Matters" by
Jim Bracher. A reader asked a pertinent question: "What
can I do to make sure I don't die because of a faulty
product?" I was wondering the same thing.
The concept of integrity has its roots in the relationship
one has with family, friends and, yes, especially with
customers. Integrity does matter. It is the cornerstone
of trust. Will I trust a new device from Guidant, if
one is offered?
I am the CEO of a Strategy Consulting firm that deals
with corporate growth and profitability. I advise companies
on how to be "customer centric" as a balance
to internal financial/operational issues, as well as
being the not-so- proud owner of an implanted Guidant
Your publication should be commended for printing Bracher's
Pete Bogda, CEO, ABA Consulting Inc.