Saturday, April 20, 2013

Hoffman-La Roche, Accutane: Goodbye Severe Acne, Hello Hideous Side Effects (2009)

By: Elise Gaudreau (2013)

Hoffman-La Roche, Inc. (referred to as Roche) is an international pharmaceutical company. It was founded in 1896 by Fritz Hoffman-La Roche, a 28 year old entrepreneur. His goal, a goal upheld by the company today, was to invent and produce new superior drugs and to distribute them internationally. In 1982, Roche introduced a prescription drug to the public unlike anything they had ever seen before. The drug they put on the market was FDA approved Accutane (also known as isotretinoin). This medication was to aid those who suffered from severe acne, finally offering a solution to a seemingly endless battle. To many patients, this was like a miracle, because they’d given up seeking treatment after seeing little to no results. The drug treats severe cystic acne, which is incredibly painful and causes scarring. It promised long lasting results, and 80% of patients saw complete reduction of their acne. For individuals who suffer this condition, this truly is a sensational drug, or so it would seem...

Within a year, a report surfaced that a baby was born with malformations due to fetal exposure of Accutane. In 1983, the FDA required the company to send out two “Dear Doctor letters”. The FDA requires drug manufacturers to send out these letters if a drug label is incomplete in listing the extent and severity of possible side effects. Within the years of 1984 to 1988, the FDA required Roche to produce seven more of these letters. Side effects that were discovered ranged from inflammatory bowel disease, Crohn’s Disease, ulcerative colitis, suicidal tendencies, and birth defects. A patient treated with Accutane actually had to have one of his organs removed due to such extreme damage! After 37 suicides and hundreds of hospitalizations were linked to prescription Accutane, it was labeled the 4th highest drug with adverse reactions. Following decades of reports of such severe adverse side effects, the FDA issued a black-box warning and Roche recalled Accutane in 2009. This drug is still available by prescription, if the case of acne is severe enough. 

Stakeholders included in this case are Hoffman-La Roche, patients taking Accutane, babies born with birth defects due to fetal Accutane exposure, families of patients taking Accutane, doctors prescribing Accutane, people working in factories manufacturing and producing Accutane, supplementary doctors that patients have had to seek care from, and lawyers of Accutane lawsuits. According to the four major theories including Individualism, Utilitarianism, Kantianism and Virtue Theory, Hoffman-La Roche's actions were mostly ethical. 

The ethical theory of Individualism focuses on egoism and rights-based constraints. Milton Friedman’s (1912-2006) theory of Individualism focused on maximizing profits for the organization, so long as their actions are within the boundaries of the law, such actions are ethical. According to Friedman’s theory of Individualism the company focused on maximizing their profits by providing Accutane. In doing so, Hoffman-La Roche remained within the boundaries of the law and so their actions were ethical.

Utilitarianism focuses on maximizing the greatest good for the greatest number. In considering this theory, one must consider the stakeholders involved in this case. The stakeholders include the company itself, Hoffman-La Roche, Inc., the patients taking Accutane, children born with birth defects due to fetal exposure of Accutane, families of patients taking Accutane, the doctors prescribing Accutane, people working in factories producing Accutane, supplementary doctors that patients have had to seek care due to damages from Accutane, lawyers involved in Accutane lawsuits, etc. When Roche first made this drug available, there is no question of their good intentions. This is to say that they were trying to introduce a drug to a population which suffers a terrible condition, and wanted to produce the greatest good for an immense amount of people. 
However, their ethics failed them when they failed to pull this drug off the market years before they did. Although the success rates of this drug are very high, what good is clear skin with the hideous side effects

of Crohn’s disease, ulcerative colitis, and suicidal tendencies? Due to the fact that so many people suffered these same adverse side effects, this does not do the greatest good to the greatest number of people. This displays the greed of the company, and how it exploited a vulnerable population. Forty-two percent of children exposed to Accutane during fetal development were born with birth defects including missing ears, cleft palate, and facial dysmophism. Furthermore, patients were forced to seek care from other doctors due to side effects like psychiatric disorders and gastrointestinal complications. Many patients have sued for these reasons and received massive settlements. For example, Andrew McCarrell, an Accutane patient who suffered damage so badly he needed five surgeries and the removal of his colon, received $25.16 million from Hoffman- La Roche. It is for all these reasons that the actions of Hoffman-La Roche are unethical according to Utilitarianism. This organization’s actions did not produce the greatest good for the greatest number; in fact, it caused severe damage for its own financial gain.

Another major ethical theory is Kantianism, from the ideas of Immanuel Kant (1724-1804). These concepts focus on rational, logical and consistent actions motivated by Good Will. Kant also operates under the Formula of Universal Law, that in order to be rational, one must be logical and to be logical one must be consistent. Inconsistency is illogical and therefore irrational and unethical. Applying this theory to Roche, it can be argued the organization's actions are ethical. This company’s mission is to provide innovative drugs that will solve any and all ailments that we face throughout our lives. By providing Accutane,
Roche’s actions were consistent with their founding mission statement which is still their goal today. By being consistent with their mission statement, one would argue that Roche’s actions to provide such a potent drug as Accutane was logical. Therefore, in acting in a consistent and logical manner, Roche’s actions in keeping Accutane on the market for as long as they did were rational actions, because they align with the organization’s mission. Following a rational, logical, and consistent course of action, Hoffman-La Roche uses the Formula of Universal Law in their organization’s practices. Therefore, their actions are ethical according to Kant.

Virtue Theory is the last major ethical theory to be discussed. This theory focuses on four main virtues of character: Courage, Honesty, Temperance/Self Control, and Justice/Fairness. Expanding on these virtues and applying them to business, Courage is risk-taking, Honesty is used throughout the organizational world, Temperance is having sensible expectations and desires, and Justice can be shown with hard work, quality products, ideas, and practices. Hoffman-La Roche took too large of a risk at the expense of their patients, therefore, the courageous acts are too rash. They were honest about the side effects but only after they occurred to the detriment of too many patients and malformed babies were born. Therefore, omitting information in this case is considered dishonest. Hoffman-La Roche had superior control since Accutane became available and people became aware of the dangerous side effects. The organization remained composed, yet still held high expectations and
desires that the drug would be successful- and it was! Hoffman-La Roche is an organization that has a virtue of Justice, although Accutane is a questionable product. The idea behind the drug was phenomenal, and no one can dispute that. In addition, they followed fair practices to pay the damages to patients who had suffered significantly. They also worked hard to keep issuing warnings to patients and the public as they continued finding out new information regarding side effects. Therefore, Roche is not entirely ethical or unethical. They are a company with virtues of Justice and Temperance, but are lacking virtues of Courage and Honesty.

As a fair solution to the problem, Hoffman-La Roche should consider paying damages to those who have suffered. However, the time frame on these claims will be from 1982 to 2009. Also, Hoffman-La Roche will only pay damages for "major side effects" such as Crohn’s disease, ulcerative colitis, Inflammatory Bowel disease, birth defects, and unfounded suicidal/depressive tendencies. "Unfounded" means the patient had no history prior to taking the drug.

Hoffman-La Roche also has the option to sell Accutane again to a select few, with the contingency that they are not liable for the side effects. To achieve this, they would have to have an agreement with the patient that they understand the risk they are taking and are doing it with the knowledge that they cannot hold the company responsible for any damages. To avoid future problems, the medical professionals as well as the public must be warned of the dangers of this drug. It should be reserved for severe cases only as a last resort. If there are any warning signs of side effects during treatment, patients should terminate treatment immediately. Although Roche cannot completely protect customers from potential side effects, doctors can screen better. To better ensure customer safety, those who prescribe

Accutane will be required to request extensive amounts of information from any prospective patient regarding physical and psychiatric history, as a precautionary measure. They will also be required to get full details regarding the individual’s gastrointestinal history and health. In addition, female prospective patients will be required to provide negative pregnancy tests prior to and during treatment, as further precaution. The purpose of this is not to be invasive, but rather, in an aggressive pursuit to protect a developing fetus from this powerful medication. Doctors prescribing Accutane must disclose all the potential side effects of Accutane. By putting Accutane back on the market with such a contingency, adding screenings, and better educating everyone involved including patients and doctors, the Hoffman-La Roche will avoid problems in the future and still make a profit with Accutane.

—DesJardins, Joseph R. An Introduction to Business Ethics. 4th ed. New York: McGraw-Hill, 2011. Print.
—Roche USA. Hoffmann- La Roche Inc., n.d. Web. 1 Apr. 2013. <>.
—Roche - Milestones. F. Hoffmann-La Roche Ltd, n.d. Web. 01 Apr. 2013. <>.
—Salazar, Heather. Business Ethics Lectures. WNEU. Spring 2013.
—Salazar, Heather. "Kantian Business Ethics." Business in Ethical Focus. N.p.: Broadview, 2008.
—"What Is Accutane? Its Uses and Interactions." Accutane. Drugwatch, 19 Mar. 2013. Web. 01 Apr. 2013. <>.

1 comment: