Wednesday, November 25, 2015

Johnson & Johnson-Risperdal: Manipulation and Deceit for Profits(2015)

Case Study
Johnson & Johnson(J&J) has been one of the most trusted brands in the world for a very long time and its name has come to be synonymous with quality. Going back over 100 years families have trusted J&J products in their households to do everything from washing their hair to relieving their pain. Since its inception in 1886 Johnson & Johnson has created a great number of products and services, and has even branched out to the pharmaceutical industry. The pharmaceutical company they own is called Janssen Pharmaceutica, and much of this controversy will result from their practices within the Janssen branch of the company, which is a subsidiary company within the J&J corporate structure(Pollack1)

Risperdal 2mg tablets
Ethics Case Controversy
In 1986 J&J's biggest money making drug Haldol was coming off of patent, which meant that it would soon be undercut by generic versions and they would be losing the enormous profit the drug had brought them. So the company set out to find a new blockbuster drug which could be under patent for years to come and came up with a drug they named Risperdal. This new drug was extremely powerful, physically addictive, and had a litany of side effects, however it was very effective in treating severe psychotic episodes in patients with bad mental conditions. Risperdal would gain limited FDA approval in 1993, but only for severe psychotic disorders. This approval meant that for J&J the drug was legally only marketable to about .05% of the population, which greatly limited its ability to make money. The corporate executives at the company had visions of selling the drug to 5-10% of the population, and through their actions they made it clear they were going to do whatever they could to make this vision a reality. 
Effects Risperdal had on children in early trials

Effects on children in early trials:
J&J conducted a great deal of studies to learn about the effects of the drug and to figure out just how bad the side effects were; the results of this research would be horrifying. The research concluded that Risperdal caused Gynecomastia (growth of female breasts on boys) in over 5% of cases. It also found that the drug causes early death in a great deal of elderly patients. Instead of releasing this information to the public J&J kept it secret and ignored the results. This is an enormous violation of the ethical honor system that existed between pharmaceutical companies and the FDA(Brill). They would apply to the FDA in 1995 and 1996 asking for the label approval to be expanded to include adolescent and elderly patients, and the FDA would subsequently deny their applications multiple times. 

J&J still held on to the belief that they could turn Risperdal into a blockbuster drug, despite the warnings of researchers. They had a problem though and the FDA wasn't budging on the label expansion requests. So they set out to create a massive marketing program to advertise to doctors for off-label use of the drug. Off-label use is when a drug is used for a condition other than what the FDA approved it for, and this use is completely at the discretion of each individual patients doctor. The advertising rules for off label use are much stricter and advertising directly to patients is against the law(Bioworld). In 1998 J&J set up an "ElderCare Center" staffed by 83 people to cater towards marketing the drug to the elderly care centers for off label use. J&J wanted to make Risperdal a household name used by people all over the country, for conditions as simple as ADHD or aggressive behavior in the elderly. They marketed the drug as a treatment for young children that wouldn't behave and set up marketing teams to convince pediatricians the drug was a good option for their patients. One of the advertising sets they gave to nursing homes read "Hostile on the outside, fragile on the inside"(Pollack). At one point the FDA even steps in a rejects promotional material that J&J had intended to distribute. They do all of this knowing full well the high likelihood of negative effects that the drug has, especially on the most vulnerable patient demographics: adolescents and elderly.

By the time that 2007 rolled around Risperdal sales had reached over $3 Billion a year and they had successfully expanded their market to include millions of adolescents and elderly patients(Brill). The drug was a Blockbuster just like the company had imagined. Only problem was that their were tons of cases all over the country where people had experienced severe side effects from the drug and their were long lasting damages they had sustained from the drug. From extreme breast growth in boys, endocrine system damage, and kidney and liver damage, to Elderly patients dying of heart and liver problems, the drug had caused a great deal of damage. Johnson and Johnson had succeed in their aggressive marketing strategy, but they had violated many laws and ethical codes in the process. In 2012 after hundreds of lawsuits across the country Johnson & Johnson would settle with the government for $2.2 Billion dollars. "As part of the settlement, Johnson & Johnson has agreed to plead guilty to a criminal misdemeanor, acknowledging that it improperly marketed Risperdal to older adults for unapproved uses"(Reuters). The drug had made the company a great deal of money, but they had irreversibly damaged the lives of thousands of people, and we will never know the true extent of the damage they caused.

Eric H. Holder Jr., the United States attorney general,
 said the company put at risk the
 health of vulnerable members of society(Reuters)
One of the biggest stakeholders in this controversy is the Johnson & Johnson and the J&J brand. This is a company that had a stelar reputation for over a hundred years and has responded very effectively to past controversies. So much of what makes the J&J brand so attractive to consumers is that they feel like they can trust it and feel safe using those products for their family. This breaches that trust and can really hurt the public perception of the company and they will be feeling the effects of this controversy for years to come. Another huge stakeholder is the American people. J&J is a publicly traded company, meaning that anybody is able to buy stock in the company. Due to its past success J&J stock is considered a "Blue Chip" stock and is part of just about every Americans retirement portfolio; so when the fines and settlements came down a great deal of americans were left paying part of the price through their stock in the company. Lastly, and most sadly, are the patients who took Risperdal at the encouragement of their doctors who were being aggressively marketed to by J&J. These patients often ended up suffering from Diabetes, Gynecomastia, weight gain, and even seizures (Brill2) due to taking the medication.

Individualism is moral stance that emphasizes the worth of the individual. It places an emphasis on the person over that of the establishment or the broad overall well being of the total population. From this perspective a person should do what is best for them and what maximizes their potential and what gets them the best result. This concept disregards the needs of others or what is best for them
Analyzing this case from the individualism approach is somewhat difficult due to the great differences between the stakeholders in the case. If we start by taking the perspective of the executives at the company they actually took a very individualistic outlook throughout the situation. They did what was best for their profits and for their career progress, they disregarded the negative effects that their action would have on many other people and the overall effects on society. However from the perspective of a patient taking the medication, they had their worth disregarded, and had a net negative effect on their health from this situation. Many of them will be suffering for a very long time to come and they can certainly say they were wronged ethically.

Using this approach to judge the actions of Johnson & Johnson and its executives/decision makers, we can clearly see that what they did was extremely unethical and subtracted from the greater good. The numerous health effects that resulted from the off label use of Risperdal will have effects on people for years to come, and many elderly have already lost their lives to this drug. The actions of Johnson & Johnson broke the inherent trust that had been built up for over 100 years between the company and the people. In the future potentially lifesaving medication will be less likely to be approved by the FDA because of the abuse of the system J&J committed. Doctors will be less likely to believe a company when they tell them a certain drug can greatly improve a person’s quality of life. From the utilitarian perspective everyone involved from the decision maker side acted extremely unethically and showed a complete disregard for the overall greater good of the people, and showed that they were completely willing to put profits ahead of ethics.

Virtue Theory
Looking at this situation under this ethical theory is interesting because of the stakeholders involved, and because we don’t know for sure what their motivations always were. There seems to be a time where the intention of the decision makers was to help people, and for a long time the company fostered the virtues of caring and self-control in the face of profits. It seems like the corporate culture at J&J took a turn for the worse around the time they introduced Risperdal, and from there they continued to reward executives for finding new ways to sell more the drug in the face of damaging study results. Through their actions they showed that they had changed to value character vices such as Selfishness, Greed, Callousness, and over the top competitiveness.

Kantian ethics places great emphasis on a persons intentions- and the morality of an act is determined by the intentions that were behind it. The intentions of many of the stakeholders in this case were not ethically sound, in fact they were very morally reprehensible to say the least. For many of the employees of Johnson & Johnson and the subsidiary Jansenn Pharmaceuticals they made the conscious decision to value making money and meeting sales goals over trying to help people with their drug. Their intentions were unethical, and therefore there acts were unethical.

Justified Ethics Evaluation
In my opinion the actions of the decision makers at Johnson & Johnson are despicable, they show an unrivaled amount of callousness and selfishness and truly represent the worst that corporate America has to offer. Out of all the ethical theories presented it is very hard to find any logic where the actions of these people were ethical or acceptable. The truth is that these people made a conscious decision to put profits and their own individual success over the health and well being of millions of people all around the world. It should also be mentioned that this is completely contrary to their own moral “Credo” code of conduct(Our Company1). Not only did they not tell the truth about Risperdal, they purposefully concealed the truth knowing full well what the consequences would be. They knew from the dozens of studies they had commissioned that Risperdal was not safe for the Elderly; that it caused heart attacks and stroke and had a high rate of early death. They also knew from these studies that Risperdal was not safe for Adolescents; that it caused boys to grow female breasts (One 13 year old developed 46DD breasts)(Brill3) they knew that it caused Diabetes and endocrine problems, and a litany of other issues. Yet none of them took any steps to slow down their aggressive doctor marketing schemes or their misleading advertising in which they were spending millions of dollars to distribute across the country. 
The "Credo" located at the entrance of J&J main offices

I believe that what should have happened is that after the first study was presented to them that showed the 5% chance of Gynecomastia and high risk for diabetes they should have completely halted sales to adolescents and stopped marketing to pediatricians until further studies could be completed. If they had done what they were supposed to do according to their own ethics "Credo" code, and put the patient first, then they would have never tried to get elderly or young children to take the drug in first place. The warnings from the FDA should have been the first warning sign and the company should have listened when they were told not to market to adolescents and to elderly.

Works Cited
Brill, Steven. "The Credo Company." The Huffington Post. Web. 22 Oct. 2015.
DesJardins, Joseph R. An Introduction to Business Ethics. 3rd ed. New York, NY: McGraw-Hill                                    .         Higher Education, 2009. Print.
"Johnson & Johnson to Pay $2.2 Billion to End U.S. Drug Probes." Reuters. Thomson Reuters,                     .         4 Nov. 2013.Web. 20 Oct. 2015.
"Our Company." Our Credo Values. Johnson & Johnson. Web. 20 Oct. 2015.
"Off-label Use: The Fine Line Between Illegal Promotion and Useful Information." BioWorld.    .         Web. 26 Nov. 2015.

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