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Avandia: Legal and Ethical Issues
November 15, 2010
PHI 300, Section 2
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In the pharmaceutical field, GlaxoSmithKline (GSK) has been a leader in
developing drugs for treatment and prevention of diseases. One of GSK’s major products
is the drug Avandia, which has been under scrutiny by the FDA for the past few years.
”Avandia, a blockbuster drug used to treat type 2 diabetes, is at risk of being pulled by
American safety regulators because of ongoing concerns over its connection to heart
attacks” (Drummond, 2010, para 1). I will argue that GSK knew of the harmful side
effects and risks associated with Avandia, and the company continued to market and
distribute the medication to increase company profit.
Avandia is the trade name for Rosiglitazone Maleate, an anti-diabetic drug which
is part of the Thiazolidinediones classification. Avandia decreases glucose levels by
increasing target cell response to insulin in Type 2 diabetes. It improves tissue sensitivity
to insulin, thus reducing cell resistance. It also suppresses hepatic glucose production.
Avandia works best in conjunction with diet in the treatment of Type 2 diabetes. The
drug is often combined with metformin, another oral anti-diabetic drug (Pearson Nurse’s
Drug Guide, 2010).
The major pharmaceutical company GlaxoSmithKline (GSK) has experienced a
drop in profits in the third quarter due to several factors. One factor includes cautious
health care spending which is related to the new U.S. heath care reform and European
price cuts. The second factor is decreased use of the drug Avandia by consumers because
of the restrictions to this drug and concern over the risk of heart attacks. GSK also
disclosed in its report that the company has been subpoenaed by U.S. officials concerning
their drug Avandia. The basis of the inquiry is concern for the way GSK has been
marketing and developing Avandia (Whalen, 2010). Since 2007 there have been many
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cases of heart attack and strokes associated with patients who were taking Avandia. The
Food and Drug Administration (FDA) has required GSK to put more warnings of the
drug’s risks on the bottle. The FDA also conducted a study where they discovered that a
person who takes Avandia is 43% more at risk for a heart attack. GSK stood strong by its
product though. They conducted an internal study and the results were,” The drug works,
and the benefits outweigh the risks” (Drummond, 2010, para 6). The controversy about
Avandia has hurt GSK’s profits due to legal cases. Since the public has been made aware
of the risks of Avandia, GSK has experienced about 13,000 legal challenges. The
company also had to pay over sixty million dollars to settle these cases. Earlier this year a
Senate Finance Committee report suggested GSK knew about the increased risk of
cardiac problems associated with Avandia, and had this information for several years.
The company also minimized the importance of the information to physicians who had
concerns about the medication and were still prescribing the drug (Whalen, 2010).
There are many reasons why GSK is ethically wrong in the decisions they are
making with Avandia. The key issue that GSK has in this case is that they were aware of
the health risks associated with taking Avandia. The most devastating fact is that they
might have known about the health risks when Avandia was first introduced over eleven
years ago. As mentioned previously, GSK knowingly understated the risks associated
with Avandia. Therefore many physicians continued to prescribe the medication to their
Type 2 diabetic patients. Avandia proved to be a drug that was beneficial to diabetics for
glucose control and it has been widely used with good results. This current information
about the risks of cardiac events is a major setback for both patients and physicians who
found the drug to be effective. GSK has a moral responsibility to disclose to the public all
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the information from their studies of Avandia. They broke their responsibility to their
consumers by downplaying vital information. The company should have been
forthcoming when they first learned about the possible risks; instead, the information was
only revealed when the FDA prompted them to reveal the facts and put additional
warning labels on Avandia medication bottles. According to an article in the New York
Times, Dr. David Graham, a drug safety officer at the FDA, “called for withdrawing the
drug and estimated that its toxic effects on the heart had caused up to 205,000 heart
attacks and strokes, some fatal, from 1999 to 2006. For every month Avandia is sold, Dr.
Graham said, 1,600 to 2,200 patients will suffer more of those problems” (Harris, 2007).
Trust is a major component in the relationship between the consumer and the
product. Patients rely on their physicians to prescribe the best drug for their illness, and
physicians rely on the drug company to develop and supply a safe drug. There has been a
major breakdown in this connection from consumer to physician to manufacturer. It
seems that GSK was only concerned for making a profit. It is morally wrong for a
company to only be concerned about the “bottom line” when a person’s life can be
jeopardized by using a medication without full disclosure of risks.
In defense of GSK, they have been a leader in research and development for
diabetes medication. Avandia has proven to be effective in treatment of Type 2 diabetes.
The question now is should people stop taking the drug completely? Are the benefits
greater than the risks? The FDA recently voted to allow Avandia to stay on the market in
America with specific restrictions. These restrictions ensure that physicians and patients
are aware of the complications that could develop with taking Avandia. The drug will be
available to new patients only if other diabetic drugs were unsuccessful in controlling
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blood glucose levels. New patients taking Avandia will have to sign a consent form
which acknowledges the possible risks (Salahi, 2010).
Drug companies and the FDA cannot be blamed for everything. “Since diabetics
are already predisposed to heart risks it is extremely difficult to tell which heart attacks
are drug-related and which are simply caused by the disease” (Perrone, 2010). It is hard
to tell which patients had these heart complications while taking Avandia. The general
public is quick to blame the medicine for the problem that occurs without actually
looking into the situation fully. GSK also has an obligation to make profits by marketing
and selling their product. The company has a duty to the shareholders to make as much
money possible to increase the price of the company’s stock. To ensure this happens,
GSK has to protect their product from being removed from the market.
In conclusion, the defenses for GSK are not plausible. The company should have
been upfront with everyone from the beginning. It does not make it right to be forced to
put restrictions on the drug years after it was introduced on the market. GSK also should
have implemented consent forms to new patients taking Avandia from early on. The
health of these diabetes patients should have been their number one concern. Patients rely
on drug manufacturers to provide them a drug that will increase their health, not make it
worse. GSK was mainly focused on making money at any costs. Most big businesses will
defend the fact that they need to make money to keep the shareholders happy. A business
cannot put a price on someone’s life. That is exactly what GSK did in the Avandia case.
They were only looking out for their best interest.
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References
Drummond, K. (2010) All about Avandia: 6 things to know about the controversial
diabetes drug. Retrieved on November 12, 2010, from
http://www.aolnews.com/article/avandia-key-questions-about-the-controversialdiabetes-drug-answered/19551984
Harris, G. (2007). Diabetes drug backed, but with warnings. Retrieved on November 13,
2010 from
http://www.nytimes.com/2007/07/31/health/31drug.html?_r=1&ref=avandiadrug
Perrone, M. (2010). FDA panel votes to keep Avandia on the market. Retrieved on
November 13, 2010 from http://www.msnbc.msn.com/id/38240727/ns/healthdiabetes/
Salahi, L. (2010). Avandia stays, but only for some diabetes patients. Retrieved on
November 13, 2010 from http://abcnews.go.com/Health/DiabetesNews/fdarestricts-avandia-patients/story?id=11709403
Whalen, J (2010, October 22). Glaxo Subpoenaed on Avandia in U.S. The Wall Street
Journal, pp. B4.
Wilson, B., Shannon, M., and Shields, K. (2010). Pearson Nurse’s Drug Guide 2010.
Upper Saddle River, NJ: Pearson Education, Inc.