Monday, November 23, 2020

Purdue Pharma Pleads Guilty to Criminal Charges Regarding OxyContin (2020)

Abstract

            Purdue Pharma is a pharmaceutical corporation known for the creation and production of one of the most used, and prescribed opioids, OxyContin.

Throughout the past few decades, the opioid crisis has been fueled by drugs such as OxyContin, Fentanyl, and Hydrocodone. Recently, Purdue Pharmaceuticals has been in the media for the multitude of lawsuits and court cases against them regarding their contribution to the opioid crisis, and their failure to inform medical professionals the effect that OxyContin could have on a consumer. Over the past few year there have been lawsuits in 49 of the 50 states, in Washington D.C, and other U.S territories against Purdue Pharma and their actions, and contributions to the opioid crisis.

This paper will take the actions from Purdue Pharma, and evaluate them using the ethical theories, Individualism, Utilitarianism, Kantianism, and Virtue Theory. According to Individualism, Purdue Pharma acted ethically because they acted within the law and made a profit for their company. When looking at Utilitarianism, Purdue Pharma did not act ethically because in the end, not everybody was happy with the outcome of the decisions of the company. Using Kantianism to evaluate Purdue Pharma, they acted unethically because it seemed as if they were using the customers as an end, not a mere means, just to make a profit. Lastly, according to Virtue Theory Purdue Pharma acted unethically because they were not honest or transparent in their actions.

Opioid Crisis Background

            In the early 1990’s, the Opioid Epidemic, otherwise known as the Opioid Crisis, began. Pharmaceutical Companies such as Purdue Pharmaceuticals, Mallinckrodt Pharmaceuticals, and Amneal Pharmaceuticals started to produce synthetic drugs for pain relief. Oxycodone (Purdue Pharmaceuticals), Hydrocodone (Mallinckrodt Pharmaceuticals), Tramadol (Amneal Pharmaceuticals), and Fentanyl, which was produced by Dr. Paul Janssen of Belgium, are the most prescribed and used opioids that the Food and Drug Administration (FDA) has approved (Medline Plus). Heroin is also a commonly used opioid, however it is not approved by the FDA, and is currently an illegal substance.

OxyContin, created by Purdue Pharma in 1996

Patients are prescribed opioids for pain after a surgery, or an injury. Originally pharmaceutical companies assured doctors that it would be challenging to become addicted or misuse opioids, however as they became more popular people started to develop tolerances, and addictions. According to the National Institute on Drug Abuse, it is shown that “roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.” Once it became apparent that opioids were harmful, and addictive, doctors started to have conventions, and large meetings talking about the dangers and effects that opioids have on the human body. It is estimated that approximately 4 to 6 percent of people who misuse prescription opioids transition to using heroin, and about 80% of people who use heroin first misused prescription opioids (National Institute on Drug Abuse).

Purdue Pharmaceuticals Background

            Purdue Pharmaceuticals was founded in 1892 by John Purdue Gray, and George Frederick Bingham. This company is based out of Stamford, CT. In 1952, Purdue Pharma was sold to Raymond and Mortimer Sackler who took the business to Yonkers, New York. Currently Purdue Pharmaceuticals is owned by the Sackler Family.

            In the 1990’s, Purdue Pharmaceuticals introduced OxyContin, which is one of the most used, and prescribed opioids. Purdue Pharma’s target market was aimed at not only cancer patients, but all patients with chronic pain. Between the years of 1996 and 2004, Purdue Pharmaceuticals held over 40 national pain-management conferences for medical professionals to show the dangers of opioids (Zee, 2009). When OxyContin originally hit the market, the risk of addiction was misrepresented, and overlooked.

Purdue Pharma Headquarters in Stamford, CT

The Case Controversy

            When OxyContin was first produced, the real risks that it had to a person’s psychological health had not been fully disclosed to medical professionals. The risks of dependence, and addiction were overlooked, and not completely disclosed to the public.

            Over the past few decades, since OxyContin has been released to the public, it has been one of the main contributors to the Opioid crisis, which has claimed over 450,000 lives from the years of 1999 to 2018 (Centers for Disease Control and Prevention). The biggest problem that involved Purdue Pharmaceuticals, and the opioid crisis is that they did not warn or educate the medical providers about addiction or dependence once it first hit the market. Starting in 1996, and going until 2004, Purdue Pharma has held many conferences, and conventions expressing the risks and dangers of OxyContin.

            Purdue Pharmaceuticals was being sued in 49 states, Washington D.C., and various U.S. territories for a total of $2.15 trillion due to its role in the opioid crisis (Adams, 2020). In 2019, Purdue Pharmaceuticals filed for bankruptcy as part of a settlement with 24 states, and the District of Columbia (Hill, 2019). In 2019 Purdue Pharma reached a $270 million settlement in a lawsuit filed by Oklahoma, that claimed OxyContin contributed to thousands of deaths.

            Purdue Pharma plead guilty to federal criminal charges, including defrauding health agencies, and violating anti-kickback laws, for its role in igniting the opioid crisis, and agreed to pay $8 billion in settlements, and dissolve the company. Purdue Pharma as a corporation does not have $8 billion to pay the settlements so the company was said to dissolve, and the assets will be used to create a new public benefit company (Isidore, 2020). The Sackler family was also made to pay $225 million as a civil settlement, which is just a small portion of their $13 billion net worth. It is important to note that a large portion of their $13 billion net worth was generated from OxyContin sales (Hoffman and Benner, 2020).

Stakeholders

            The stakeholders in this controversy are the employees of Purdue Pharma, the Sackler Family, the medical doctors who prescribed OxyContin, the Board of Directors at Purdue Pharma, the sales team, and anybody who has a share in the company.

The Sackler Family, owners of Purdue Pharma


           
For starters, the Board of Directors, the CEO, Craig Landau, and the Owners, the Sackler Family are all involved in this controversy. Everyone played a role in the company, meaning they are all involved in the marketing, and sales of OxyContin. The sales and marketing team for Purdue Pharma also is to blame because they were the ones pushing the sales, and producing the marketing for OxyContin, when they were not giving the public the correct information about the product. In addition to the marketing team, anybody who was hired by Purdue Pharma was affected, because they could lose their jobs. The doctors, hospitals, and medical professionals who were prescribing OxyContin were also marketing the drugs.

Individualism

            Milton Friedman, Nobel-Prize winning economist says, "it is the aim and responsibility of businesses to maximize their profits" (Salazar 17). Friedman also explains that a business should not attempt to be socially responsible, and should not spend money on resources, employees, and donations to other charities because in turn that is stealing from the owners of the company. Since Purdue Pharma did everything in their power to maximize profits, there would be no actions that would be deemed unethical, therefore being permissible under individualism.

            While Purdue Pharma did everything in their power to maximize the profits of the company and maximize the profits for the stakeholders, when included aggressive marketing tactics. Purdue Pharma "violated anti-kickback laws by paying doctors, through a speaking program, to induce them to write more prescriptions for the company's opioids and for using electronic health records software to influence the prescription of pain medication" (Balsamo). While it may be viewed that Purdue Pharma acted ethically according to the individualism theory, they acted outside of the law meaning Purdue Pharma's actions are not permissible using the theory of individualism.

In order for a company's actions to be viewed ethical under individualism they must being doing everything in their power to maximize profits for the company while staying within the law. While Purdue Pharma did everything they could to maximize profits, they went against laws when marketing, meaning their actions are not permissible under the individualism theory.

Utilitarianism

Utilitarianism theory explains that "businesses should aim to maximize the happiness in the long run for all conscious beings that are affected by the business action"(Salazar 19). When OxyContin first hit the market in the 1990's, Purdue Pharma's actions would have been viewed as permissible under the Utilitarianism theory. At that time, doctors were thrilled to have a drug that would reduce pain, while having a lower likelihood of addiction. Consumers were thrilled because there was finally a solution to their chronic and severe pain. Lastly, the Sackler Family, and executives of Purdue Pharma were happy because they were making a huge profit off the sales of OxyContin. After years of OxyContin being on the market, thousands of people were affected by the drug. Consumer started to become dependent and addicted to OxyContin, leading to thousands of deaths. People were becoming addicted, and losing their lives, ultimately not being happy. Doctors were seeing the effects that the opioid had on their patients, and were disappointed in the outcome. Lastly, Purdue Pharma was not satisfied because they had a multitude of lawsuits against them, ultimately having to pay millions in fines.

Essentially the main goal of Utilitarianism is the maximize happiness in everybody involved, and in this case, nobody remained happy in the end result, meaning that Purdue Pharma's actions were not permissible by a utilitarian view. Looking at the entire case from start to finish, looking at deaths, lawsuits, settlements, and addiction nobody ended up happy. 

Kantianism

            Kantianism is to "always act in ways that respect and honor individuals and their choices. Don't lie, cheat, manipulate, or harm others to get your way. Rather, use informed and rational consent from all parties"(Salazar 20). In addition, Kantianism uses the formula of humanity, stating that everybody should be treated as an end, not a mere means. In the end, Purdue Pharma violated the formula of humanity when they used the consumers as a mere means to get a profit from their OxyContin sales. To Purdue Pharma it did not matter that people were becoming addicted, overdosing, or dying because they were making a profit, and the more they sold, the more of a profit they would make.

            The difference between Utilitarianism and Kantianism is that "Utilitarianism is concerned only with consequences of an action and Kantianism does not make decisions based on consequences, but rather on what Kant calls the 'Good Will'"(Salazar 21). Good Will is when "people have good intentions and use good reasoning to come to conclusions that make their good intentions effective"(Salazar 21). Clearly Purdue Pharma had only their best interest in their intentions, and were only working on the fact that they would make a profit, and that they would benefit for themselves. Purdue Pharma harmed thousands of people just to make a profit, which in the long run only had the top executives benefit from the payout.

            Kantianism explains that you must not lie, cheat or manipulate others to get your desired outcome. When Purdue Pharma marketed OxyContin they took away people's ability to think rationally. When people became dependent on the drug they were immediately manipulated. With this the consumers needed more and more OxyContin which in turn gave Purdue Pharma a larger profit. With that being said, Purdue Pharma's actions are impermissible under Kantianism because they manipulated consumers while also using them as a mere means.

Virtue Theory

           Virtue Theory is to "act so as to embody a variety of virtuous or good character traits and so as to avoid vicious or bad character traits" (Salazar 22). Clearly Purdue Pharma did not act based on good character traits and did not do whatever they could to avoid having poor character. Virtue Theory evaluates "virtues or the opposite of virtues, which are called 'vices.' Courage, honesty, wisdom, justice, prudence, temperance, intelligence, insight, are, compassion, leadership and teamwork are just a few of the many virtues that can help business people....a few vices that have been severely detrimental to overwise savvy and innovative business people are greed, dishonesty, and selfishness" (Salazar 23). 

    Purdue Pharma demonstrated actions that correspond with the detrimental vices. To start, the Sackler Family, and the top executives were so greedy and money hungry that they did whatever they wanted, harmed whoever, and went against their moral values to make money and to make a profit. In addition to greed, they were selfish and only looked after themselves when producing OxyContin. Their selfishness stems from their greed, in them wanting to have more money in their pockets, and fueling a problem that could be resolved if they acted ethically. They were also dishonest with the consumers and doctors when first marketing OxyContin. Purdue Pharma lied about the dangers of taking the drug, and the possible consequences that could come from consuming the opioid. Purdue Pharma's actions are impermissible by Virtue Theory because they went against all the good virtues, and acted on bad or poor characteristics

Justified Ethics Evaluation

            In my opinion Purdue Pharmaceuticals actions were unethical and morally incorrect. Purdue Pharma could have avoided most of the problems that were caused if they were upfront and direct about the effects that OxyContin had on the consumer. Rather than being transparent, Purdue Pharma was focused on the sales and marketing of the new opioid.

            Purdue Pharma, and the scientists creating the drugs had to be aware of the side effects, the risks, and the dangers of prescribing the drug, however they overlooked it, and did not properly explain the risks to doctors and medical professionals. Purdue Pharma should have known that the safety of the consumers was at risk, and with knowing that they should have taken the proper actions to either revise the drug to make it less harmful to the consumers, or properly educate the medical professionals who are marketing and prescribing this opioid.

            When OxyContin started to become the biggest factor in the opioid crisis, Purdue Pharma failed to recall OxyContin from the market, or do anything to alter the chemical makeup of the substance. Instead of finding a solution to OxyContin fueling the opioid crisis, Purdue Pharma stood by, and in the long run, it ended up harming them, as they had to pay billions of dollars in settlements, and file for bankruptcy.

            Overall, Purdue Pharmaceuticals did not do what an ethically driven corporation would have done. A company that practices basic morals and ethics would find a proper solution to keep the wellbeing of the consumers at first hand. Purdue Pharmaceuticals did not operate on an ethically driven basis because they were not looking out for everybody who could have been affected by the marketing of OxyContin.

Action Plan

Throughout the past decades the opioid crisis has been a prominent problem in United States. Pharmaceutical companies created opioids with the idea in mind that they would be helping patients deal with paid after injuries, or surgeries, rather people started to become dependent and addicted to the substances.

While it might not have been easy, or economically feasible at the time, Purdue Pharma could have recalled OxyContin because it was destructive to public health, and could have either found a better alternative to OxyContin, or could have changed the chemical makeup of the substance to make it less addictive or mind-altering. In addition to recalling the opioid, Purdue Pharma could have had better marketing tactics, and provided more clear and concise information regarding the dangers of taking OxyContin.

Purdue Pharma as a corporation needs to have a mission statement to demonstrate and explain their values, and beliefs as a company. An example of a mission statement would be, while excelling in the pursuit of new medicines, compassionate, and the safety of our customers is at the forefront of our decisions.

In addition to the mission statement the company should have a set of core values and beliefs in which their corporation revolves around. Some values may include the physical and mental safety of the customer, transparency, honesty, innovation, and compassion. The biggest value should be the safety, both mentally and physically of the customer. If the majority of the customer base is not responding to the drug as desired, and it is harmful to their health, ethically Purdue Pharma should do something to help, considering they produced the product in the first place. Along with safety, compassion and willingness to care are values that should be upheld by Purdue Pharma. The corporation should be honest with the public about the product they are marketing, and fully transparent in not only the marketing process, but also in the research and development process. Lastly, innovation is a key value considering Purdue Pharma creates, innovates, and produces.

To ensure ethical productivity, and prevent unethical behavior, it would be in Purdue Pharma’s best interest to start by recalling OxyContin and making in unavailable to all consumers. In addition, Purdue Pharma should consult a panel of doctors, researchers, and medical professionals while they develop new drugs to, they are safe for the consumer. Lastly, there should be intensified trainings with new and current employees going over the dangers of drugs use, and how they can help the community.

One solution is that Purdue Pharma should hire different doctors and researchers who would belong to the company. This will ensure that they are always available to give their input and are able to evaluate the new drugs that are being introduced to the market. This will also allow the company to become aware of the risks, and dangers that consumers could endure when taking any drug. In addition to hiring doctors and researchers, Purdue Pharma should also fire people on the marketing team who did not act with full transparency when advertising the product, while also firing any executive board member, or scientist who had a hand in creating the opioid, knew the dangers of it, and failed to say anything to the public.

It would be in the best interest of Purdue Pharma to fully disclose the side effects and problems that occur or can occur when taking the drug, and make sure that it is clear enough for the general public to understand. The marketing team should not use any technical jargon, or medical terms that could be confusing for the consumers to understand and interpret.

This proposed plan will benefit Purdue Pharma, and increase not only productivity and profits for a variety of reasons. First, acknowledging your mistake, and taking the proper action to correct it will instill more trust from the consumers in you. With this, the company will be more profitable because people will want to invest and purchase the product that Purdue Pharma is creating. The proposed plan conforms to the mission statement and values because it is keeping the safety of the consumers at hand, which is the most important idea, while also acting ethically and socially responsible for their actions in the present and in the future.

Nicole Bourgeois

References

Adams, K. (2020, August 18). 49 states file $2.15 trillion opioid epidemic lawsuit against Purdue Pharma: Purdue Pharma is being sued for $2.15 trillion by 49 states, Washington, D.C., and various U.S. territories for its role in the opioid crisis, according to CNN. Retrieved November 23, 2020, from https://www.beckershospitalreview.com/opioids/49-states-file-2-15-trillion-opioid-epidemic-lawsuit-against-purdue.html

Michael Balsamo and Geoff Mulvihill, T. (2020, October 21). U.S. Officials: OxyContin Maker To Plead Guilty To 3 Criminal Charges. Retrieved December 17, 2020, from https://www.wbur.org/commonhealth/2020/10/21/purdue-pharma-guilty-please-opioid-epidemic

Center for Disease Control (CDC). (2020, March 19). Opioid Overdose: Understanding the Epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html

Joseph, A. (2019, September 16). Purdue Pharma filed for bankruptcy. What happens with lawsuits it faces? Retrieved November 23, 2020, from https://www.statnews.com/2019/09/16/if-purdue-pharma-declares-bankruptcy-what-would-it-mean-for-lawsuits-against-the-opioid-manufacturer/

Purdue Pharmaceuticals. (2019, May 28). Purpose Statement and Values. Retrieved November, from https://www.purduepharma.com/about/ethics-and-compliance/purpose-statement-values/

Salazar, Heather. The Business Ethics Case Manual. n.d.

Shraddha Chakradhar @scchak and Casey Ross @caseymross, Chakradhar, S., Ross, C., Chakradhar Reporter, A., & Chakradhar Reporter, S. (2019, December 30). The history of OxyContin told through Purdue Pharma documents. Retrieved November 23, 2020, from https://www.statnews.com/2019/12/03/oxycontin-history-told-through-purdue-pharma-documents/

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