Company
Background
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| AbbVie Company Logo |
AbbVie is the
company that creates and sells AndroGel.
AbbVie officially become its own company on January 1, 2013 when it
separated from Abbot Laboratories. As a
result from the split, AbbVie would be functioning as a research based
pharmaceutical manufacturer. AbbVie
currently has over 28,000 employees located all over the world that work to
come up with new methodologies to addressing today’s health problems. They target specific, difficult to cure,
diseases and are always looking to produce products that go beyond treating the
illness. AbbVie presently markets more
than 30 products that are approved by the U.S. Food and Drug Administration
(FDA).
One
of their most successful and well known products is AndroGel. AndroGel is a topical treatment for men that
have low testosterone as a medical condition, not as a result from ageing. AndroGel uses the same testosterone that is
found in the human body which is why it is able to increase the testosterone
levels in men after it is absorb through the skin. Common side effects of this drug are
increased prostate, acne, and skin irritation.
However, AndroGel can also increase the risk of stroke, heart attack,
and prostate cancer. As well as liver
and kidney problems. The drug is also
able to transfer easily when there is skin to skin contact.
Ethical
Case Controversy
Over the past few
years, there have been more than 4,000 men who have filed testosterone lawsuits
against AndroGel and other similar products.
Most of the claims that have been filed are for product liability where men
have suffered heart complications including heart attacks, blood clots,
strokes, and even death. The lawsuits
state that AbbVie failed to inform customers about these risks.
As
stated before, AndroGel is one of the most used prescription testosterone drugs
on the market. It is mostly given to men
whose bodies are not able to produce an adequate amount of testosterone. This medication was approved by the FDA in
2000 for the use by men who had been diagnosed with hypogonadism. Hypogonadism is the reduction or absence of
testosterone in the body due to injury or disease. However, AndroGel has not only been
prescribed for hypogonadism. It has been
used to treat the condition known as Low-T, low testosterone. As all men age, their bodies tend to produce
less testosterone naturally. This
decline can be more drastic in some people and may cause symptoms such as loss
of muscle mass, irritability, and lowered libido. Although AndroGel is designed to improve this
condition, the lawsuits contend that the drug is not necessary and that Low-T
is not even a real condition. They say
the condition is often used incorrectly and interchangeably with hypogonadism. The lawsuits allege that the emergence of the
Low-T diagnosis is the result of disease mongering. Disease mongering is when a drug company
exaggerates the concern over a non-existent condition in which they have a way
to treat or cure. According to this
allegation, Low-T is just a normal part of the aging process and drugs like
AndroGel are a result of drug companies trying to sell more testosterone
products.
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| AndroGel Add |
The
use of AndroGel as a testosterone replacement treatment has increased intensely
in the past few years due to direct to consumer advertising and other campaigns
that were intended to create a market for treatment of Low-T, by describing
complications that are experienced by all men at certain points in their
lives. Men were encouraged to pursue
prescriptions if they experienced a lessened sex drive, sadness, weight gain,
and tiredness. Ron Johnson, a lawyer for
one of the plaintiffs, said that “testosterone drugs were heavily marketed for
a condition that the FDA hasn’t even recognized as a disease, let alone
approved any product to treat.” He later
went on to say that he also had never seen a company make up a fake disease
before. Since testosterone is only FDA
approved to treat hypogonadism, AbbVie threatened healthy men by marketing
AndroGel beyond that use. AbbVie spent
about $76 million on direct to consumer advertising for AndroGel in 2012, and
$68 million in 2013. One of the
plaintiffs in the lawsuit said that “there were a lot of commercials on at the
time about looking younger, feeling younger, and yeah, that was a partial
reason I went to see the doctor. When I
thought I could just rub this gel on myself and have all this vitality, it
seemed like a no-brainer. I was all in.”
The ads were telling the people what they wanted to hear, they could be
young again by simply rubbing a gel on themselves. However, AbbVie misled its potential users by
relaying positive information through the press, including testimonials from
retired professional athletes, while downplaying known adverse and serious
health risks (Drugwatch). Many
plaintiffs do not recall the advertisements they saw warning them about the
possible side effects at the time.
According to a study in the Journal of Clinical Endocrinology &
Metabolism, many men received AndroGel lacking any real medical necessity for
the prescription.
Stakeholders
The stakeholders in this AndroGel
case are the customers, the customer’s families, hospitals, AbbVie, and the
other testosterone medication companies.
The customers are the biggest stakeholders in this case because they are
the ones being physically affected by the product. AndroGel has or can cause customers to have
heart attacks, strokes, blood clots, and even pass away. This affects the customer’s families and
hospitals greatly. This puts extra
stress on the families when one of their loved one suffers a traumatic health
related condition. Family members may
have to commit a good portion of their lives to helping the injured family
member do simple, everyday activities, if their condition is severe. This also affects the hospitals because they
have to figure what the cause of the heart attack, stroke, blood clot, and
possible death were. This case impacts
AbbVie and its employees immensely. When
a product causes customers to have severe health problems it always hurts the
company’s image and can cause them to lose customers and potential
customers. It hurts other testosterone
medication companies for the same reason.
It scares away customers because they do not want to end up with the
same medical problems that these people have experienced because they used a
testosterone medication.
Individualism
According to Milton
Friedman, whose view is often referred to as Classical Individualism, the only
goal of a business is to maximize profits for the owners of a company within
the constraint of the law. From this
perspective, an Individualist would say that AbbVie followed this theory
because their main objective was to make a profit off of selling the AndroGel
medication. But, the main controversy
regarding Individualism is whether or not AbbVie marketed AndroGel within the
guidelines of the law. The FDA approved the use of AndroGel to treat men who
had hypogonadism. However, the drug was
being marketed to treat men who had Low-T.
The FDA hadn’t acknowledged that Low-T was a disease and had not
approved any products to treat it. Under
the rules of Individualism, AbbVie acted unethically. By marketing AndroGel as a treatment for a
disease it was not approved to treat, AbbVie was not operating within the
constraint of the law even though they were looking to maximize profits.
Utilitarianism
Utilitarianism
says to maximize happiness in yourself and others. Happiness and pleasure are the only things of
intrinsic value according to Utilitarianism.
Utilitarians are concerned about the long term costs and benefits of
actions in all affected parties (Salazar).
The stakeholders that were most directly affected were the consumers
that have filed lawsuits against AbbVie.
The benefit of them using AndroGel was to make them feel younger and
more energized again. But, the cost was
that using AndroGel caused them to suffer heart attacks, strokes, or blood
clots. The second stakeholders are the
consumer’s families. They were affected
by how AndroGel affected their loved one.
They were not happy when their family member suffered a heart attack,
stroke, or blood clot as a result of using the drug and taking on all of those
medical bills. The third stakeholders
that were affected is AbbVie. They
benefited from selling AndroGel and making a profit. However, thousands of lawsuits are going to
cost the company to lose a lot of money.
Ultimately, a Utilitarian would say that AbbVie did not act
ethically. In the long run, AbbVie did
not maximize the happiness in everyone that was affected by the use of
AndroGel. |
| AndroGel cream |
Kantianism
Kantianism focuses
on rationality and Good Will. It says
that it is wrong to manipulate and exploit people for one’s own advantage. The four basic principles of Kantianism are
act rationally, allow and help people to make rational decisions, respect
people and their individual needs and differences, and be motivated by Good
Will, seek to do what is right because it is right. To test if an action is impermissible or permissible,
Kantians use the Categorical Imperative.
The main formula used in the Categorical Imperative is the Formula of
Humanity. The Formula of Humanity says
that it is wrong to use people as a means to get what you want (Salazar). According to this theory, Kantians would say
that AbbVie did not act ethically because they failed to meet the basic
principle of allowing and helping people to make rational decisions. When marketing AndroGel, AbbVie did not warn
the customers about possible side effects such as heart attacks, stroke, blood
clots, and possible death. Without this
information, customers were not able to make rational decisions while
purchasing AndroGel. If they had known
about these serious side effects, then they would have been able to make a rational
decision.
Virtue
Theory
Virtue Theory is
about a person’s character and assesses if a person is virtuous or not. A virtue is the characteristics that allow
people to function properly. The four
main virtues are courage, honesty, temperance, and justice. Examining AbbVie’s case from Virtue Theory, AbbVie
was acting courageous. They created a
drug to try and help solve a problem that many men face as they get older. However, they were not honest. They did not tell the customers about the
potential serious side effects while marketing AndroGel. The third virtue is temperance, or self-control. AbbVie did not have self-control when
marketing AndroGel. They used aggressive
direct to consumer marketing techniques in order to grow the market for
testosterone drugs. The final virtue is
justice, or fairness. AbbVie was not
fair to its customers because they did not warn them about the possible side effects
associated with using AndroGel. So,
according to Virtue Theory, AbbVie did not act ethically.
Justified
Ethics Evaluation
In my opinion, I
think that AbbVie did not act ethically in this case. They did not give their customers enough
information to make an informed purchasing decision. I feel that if the customers had known that they
could suffer a heart attack, stroke, or blood clot by taking AndroGel, then
they would not have purchased it in the first place.
Sources
Miller,
Emily. "Testosterone Products - Gels, Injections and Patches." DrugWatch.
N.p., 13 Mar. 2014. Web. 03 Apr. 2017.
"AndroGel
Lawsuit." Saiontz & Kirk, P.A. – YouHaveALawyer.com. N.p.,
n.d. Web. 03 Apr. 2017.
Boumis,
Robert J. "Low-T Drug Lawyers Allege Obstruction by AbbVie." Top
Class Actions. N.p., 11 Feb. 2016. Web. 03 Apr. 2017
Weintraub,
Arlene. "What's Next For The Thousands Of Angry Men Suing Over
Testosterone?" Forbes. Forbes Magazine, 01 June 2015. Web. 03
Apr. 2017.
Solvay
Pharmaceuticals. AndroGel ® (testosterone Gel) 1% CIII (n.d.):
n. pag. FDA. 23 June 2009. Web.
Salazar,
Heather. "The Business Ethics Case Manual." The Authoritative
Step-by-Step Guide to Understanding and Improving the Ethics of Any Business
(2014): n. pag. Web.
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