Monday, April 3, 2017

AbbVie: Improper Marketing of AndroGel Led to Thousands of Lawsuits (2014)

Company Background
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.
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.


            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.     

            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 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 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.

Miller, Emily. "Testosterone Products - Gels, Injections and Patches." DrugWatch. N.p., 13 Mar. 2014. Web. 03 Apr. 2017.
"AndroGel Lawsuit." Saiontz & Kirk, P.A. – 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.

No comments:

Post a Comment