Pfizer: Blood Pressure Medication Recalled due to exceeding allowable level of Cancer-Causing Impurities (March 2022)

Case Controversy

Pfizer is an extremely recognizable company, founded in 1849 by Charles Pfizer and his cousin Charles Erhart. Pfizer was most recently in the news during the COVID-19 epidemic, as it was one of 3 major medical companies to formulate a vaccine against the virus. In March 2022, however, Pfizer issued a voluntary recall of several lots of different blood pressure medication including Accuretic (quinapril HCl/hydrochlorothiazide) tablets as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide). Greenstone, a wholly owned subsidiary of Pfizer, produces several other generics of other medications for Pfizer.

Accuretic, as well as its corresponding authorized genetics distributed by Greenstone, is a set of medications used to treat high blood pressure, or hypertension. Currently, it is unknown whether it is safe or effective in children under the age of 18, however, high blood pressure is typically a result of a long-term diet high in fats, salt, and/or cholesterol. Although high blood pressure can be genetic, it is unlikely to require medication at age 18 or earlier. Its empirical formula is C25H30N2O5  and its structural formula is as seen in Figure 1.

The March 2022 recall was issued for a total of 6 Accuretic tablet lots consisting of 3 different configurations (10/12.5 mg, 20/12.5 mg, and 20/25 mg) as well as one lot of quinapril and hydrochlorothiazide tablets (20/25 mg) and four lots of quinapril HCl/ hydrochlorothiazide tablets consisting of 2 configurations (20/12.5 mg and 20/25 mg). These medications were distributed between November 2019 to March 2022 and were set to expire between April 2022 and August 2024. Pfizer provided the affected lot numbers as well as the NDC’s, expiration dates, and configurations for each of the affected medications on their website.

The company released a statement on their website stating that they are issuing a volunteer recall of these specific lots of medications at “the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level”. Nitrosamines are an impurity caused by the chemical reactions of nitrites or nitrates with specific amines. Nitrosamines are not an impurity that is specific to medications. They are found within everyday consumer products including processed meats, alcoholic beverages, cosmetics, and cigarette smoke, meaning everyone is subjected to some level of nitrosamine intake. These impurities are known to lead to an increased risk in cancer if they are ingested above the acceptable daily intake level for long periods of time. Equivalently, the FDA also claims that someone ingesting medication daily at or below the acceptable daily intake level for 70 years is not expected to have any increase in cancer risk. Interestingly the FDA website states that medications found to have nitrosamine levels above the acceptable daily intake level are “recommend[ed] these drugs be recalled by the manufacturer as appropriate”, however, it is not mandatory.

When the recall was first issued, the FDA released a statement stating that “to date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.” This makes sense, as the effects of nitrosamines are not proven to have any imminent threat to life, as cancers typically develop over time due to extended over-intake. In addition, Pfizer also pointed out that their hypertension medication has a “safety profile that has been established over 20 years of marketing authorization and through a robust clinical program.” Interestingly, the FDA advises patients that are currently taking prescription medications with potential nitrosamine impurities to continue taking their medication and contact their health provider about potential concerns and other treatment options. As of the date of the initial statement release, the source of the impurities is unknown, however the agency is said to be working on determining the source and claims they will “keep the public informed”.

Stakeholders

The stakeholders in this particular case would include the Manufacturers, Current Patients, Doctor’s prescribing these medications, Future Shareholders, Future Patients, and the General Public. The future success of the company is dictated by the actions they take based on the guidelines the Food and Drug Administration provides them. Pfizer’s actions also dictate what the manufacturers of these drugs will do. The current patients who need these blood pressure medications may or may not be affected depending on if they have been on if they have been taking the medication long-term or not. The doctors who are prescribing these medications to their patients are affected by this recall because now they have to consult with all of their patients and figure out what treatment to give them now. The future shareholders are affected because what the FDA’s testing and analysis on these medications and the classification that organization gives for the drugs can alter the future value of the company’s stock once the results of the recall are released. Future patients are affected because of the medications being off the market, patients will have to seek prescriptions from other brands. The general public is affected because Pfizer’s medications are distributed all across the nation. 

Individualism

According to Dr. Salazar, a professor of philosophy at Western New England University, under Individualism, business actions should maximize profits for the owners of a business but do so within the law.  Dr. Salazar also states that, “Both versions of this theory are grounded in the responsibility of a business to its owner or owners, whether they are individual people or the stockholders of a publicly-traded company”. So, an individualist would say that Pfizer recalling their blood pressure medication is not the most ethically beneficial. In Pfizer’s case, profit was not maximized for the owner which we can see when doing further analysis of the stakeholders as the following:

Manufactures: The manufactures will negatively impact the profit for the owners of the company. Because of the recall, the manufacturers of these blood pressure medications are forced to stop making these drugs. They cannot do anything until the company receives guidelines from the FDA. Therefore, none of the blood pressure medications will be able to be sold on the market and be able to make any profit off of these prescription drugs.

Current Patients: The current patients will negatively impact the profit for the owners of the company. Because of the recall, the current patients will stop taking these medications and seek a different treatment with their healthcare provider. Therefore, the company will have to lose all of their customers that purchase and consume these medications. Therefore, the owner of the company will lose money.

The Doctors: The doctors prescribing these medications to their patients will negatively impact the profit for the owners of the company. Now that these medications are being recalled and are off the market, doctors will now consult with their patients and prescribe a different treatment. Therefore, the owner of the company will lose money.

Future Shareholders: Future shareholders who want to invest in a company will also negatively affect future profits for the owner of the company. Because of the recall and the blood pressure medication being off the market, customers will lose money and there is no certainty that these blood pressure medications from Pfizer will go back in the market.  This will decrease the value of the company and its stock price which will not attract investors.

Future Patients: The future patients will negatively impact the future profit for the owners of the company. Because the company had to recall their blood pressure medication, future patients will be prescribed blood pressure medications from different companies by their healthcare provider.

The General Public:  The general public will negatively impact the profit for the owners of the company. The general public expects pharmaceutical companies like Pfizer to come out with prescription drugs that are safe to consume. The general public will have a hard time trusting the company which will not help the owner make money.

It is obvious that Pfizer’s recall of their blood pressure medications was not ethical in an individualist’s perspective and that profit was not maximized for the company. The company has done recalls in the past and had to take certain drugs off the market, and they followed the guidelines set by the FDA. Therefore, the next step that Pfizer takes when it comes to their blood pressure medication will depend on what the FDA’s testing and analysis on these medications and the classification that organization gives for the drugs.

Utilitarianism

The main ideas surrounding utilitarianism focus on maximizing happiness and well-being equally for all parties involved.  The theory of utilitarianism states that actions are right insofar as they produce happiness but wrong if they promote unhappiness.  The theory also includes the idea that happiness and pleasure are the only thing that truly has intrinsic value.  In terms of the case controversy under the scope of utilitarianism, Pfizer attempted to maximize happiness for all parties involved and well-being equally.  Unfortunately, due to the lack of information provided by Pfizer as to when they became aware of these potentially harmful findings, it cannot be said for sure whether or not they have partaken in unethical practices. However, Pfizer voluntarily recalled their own medication; despite the negative effects it could have on the corporation financially and its reputation.  They included information on why the blood pressure medication was being recalled so as to inform both the public and patients prescribed the drug.  They also provided contact information and instructions on how to return the recalled lots and receive reimbursement for their costs.  Despite being a major pharma corporation, they put the happiness and well-being of their patients at the forefront by voluntarily recalling their medication, providing the proper information, and assuring patients of reimbursements.  They also maximize their own happiness and well-being by getting ahead of the recall and maintaining their reputation and status.  Pfizer is not financially responsible for the repercussions of taking the medication as they informed their patients and voluntarily recalling their drug before there were any cases reported.  Since the adverse effects of taking the medication are not immediate but rather occur after having large doses over an extended period of time, reporting their findings before anything bad had happened maximizes the happiness of both the corporation and patient. The stakeholders involved are affected under the scope of utilitarianism ethics as follows: 

Pfizer Manufacturers/Employees:  Pfizer voluntarily recalled their high blood pressure medication, Accuretic, because the levels of nitrosamines present were above the acceptable daily intake (ADI).  Both the manufacturers and employees of Pfizer are maximizing their happiness this way as they allow themselves to have a clear conscience as there have been no reported cases of detrimental impacts from the medication to patients.  They also maintain their company’s reputation by voluntarily recalling the drug rather than leaving it on the market to maximize profits which creates good will with their patients.  The information provided by Pfizer in regards to disposal of the affected lots and reimbursement for the patients fosters a sense of trust between the pharmaceutical corporation and its patients, in turn maximizing the happiness of Pfizer as they do not lose customers. The employees and manufacturers will also be working towards fixing the problem and ensuring it does not happen in the future, which will create more profit in the long run, ultimately maximizing their happiness.

Pfizer shareholders:  With the voluntary recall of the blood pressure medication, Pfizer shareholders are reassured that Pfizer is not financially liable for any adverse effects, and therefore maintains a positive reputation and avoids potential lawsuits which could be greatly detrimental to the company’s stock price.  By voluntarily recalling the medication and providing information and outlets to current patients, the stock price should not waiver as the company has numerous different streams of revenue not directly related to the recall and conveys that they hold the shareholders’ and consumers’ happiness at the highest regard.  This maximizes the happiness of the shareholders as the company maintains a good reputation and their social consciousness will be appealing to potential future investors which will have a positive impact on the stock price.

Doctors/Pharmacists:   The voluntary recall of the blood pressure medication by Pfizer also maximizes the happiness of doctors and pharmacists as they clear the conscience of guilt that would be had by continuing to prescribe and sell potentially tainted lots.  Due to the recall, there will be more interaction between patients and their doctors/pharmacists which will promote more business.  Doctors will meet more with patients to discuss alternative routes for medication which creates more profit and pharmacists will be selling more blood pressure medications which promotes more business, conclusively maximizing their happiness.

Patients:  Current patients of the high blood pressure medication are perhaps the most affected by this situation as they must find out whether or not they hold any of the tainted lots of the medication.  According to a study conducted by the analytics company IQVIA, there were approximately 1,300 patients using Accuretic in 2020 and another 192,000 users of the generic forms. However, they are reassured by the fact that there have been no reported cases of adverse effects and the information that these effects only occur after an extended period of use in high doses.  By Pfizer voluntarily recalling its medication, the patient is made aware of the problem and takes comfort in knowing the corporation holds its patients health in the highest regard.  Pfizer also provides information for the patient to determine whether or not they have an affected lot of the medication and urges them to contact their medical provider with any questions.  By doing this, the patients’ happiness is maximized as they are given the knowledge voluntarily and are promised reimbursement for any tainted lot as well.

It is clear that Pfizer’s voluntary recall of their blood pressure medication was an ethical act under utilitarianism made to maximize the happiness of all parties involved.  By recalling the medication voluntarily, Pfizer ensures a sense of trust between them, their shareholders, doctors/pharmacists, and their patients by a way of honesty and transparency.  They also provide avenues and reassurances for all parties which aims to maximize the happiness of each.

Kantianism

Pfizer voluntarily recalled their blood pressure medication due to the potential cancer-causing impurities. This way of handling the situation from a Kantian point of view was most definitely the most ethically beneficial for almost everyone involved. The center of Kantian ethics is based on goodwill. Goodwill is defined as the “rationality which chooses to do what is right for the reason it is good” (Salazar 4). In addition, an important aspect of Kantian ethics is Kant’s formulation of humanity. The formulation of humanity can be described as requiring humans “never to treat others merely as a means to an end, but always as ends in themselves.” This means that a business's customers are not used in achieving a particular “end” but rather treated as an end in themselves. The Kantian ethical view also entails acting with respect to all autonomous human beings. This means doing what’s morally right by the people you serve and doing it for the right intentions. In addition, Kantian ethics is reliant on the duty to do right while respecting a person’s moral rights. In this case, Pfizer acted with the duty to protect the well being of its customers while respecting their right to contact their doctor if they would like to change their medication or treatment plan. In Pfizer’s case, all of the stakeholder’s health and safety were prioritized and the well being of the customers were maximized. Ethically, each stakeholder was affected as follows:

High Blood Pressure Patients: The group of people most directly benefiting from the recall are the patients suffering from hypertension. The company issued the recall due to the well being of the patients. As the FDA’s website states, the company is recommended, but not obligated, to recall medications exceeding the acceptable daily intake levels. By Pfizer voluntarily recalling the medication shows they have acted with the goodwill of the consumer in mind, directly demonstrating what Kantian ethics is all about.

Pfizer Shareholders: Due to Pfizer’s immediate response with the thought of the customer in mind, Pfizer shareholders should benefit. Stocks should hold steady with the public knowing that the company always has the best interest of the consumer in mind. These holders indirectly benefit from Pfizer’s handling of the situation as any company who has the best interest of the consumer automatically becomes more attractive for current and future investors.

Doctors: Medical personnel can also indirectly benefit from the situation as they will have an influx of customers needing a new prescription of the contaminated drug. More business is always a good thing for anyone who is getting paid for it.

Manufacturers/Employees: These employees benefit most nearly in a similar way as the doctors. They get an influx in more work as they must continue to closely monitor the Pfizer distribution operation. They also have more work to try to find the source of the impurities themselves. This will help to ensure similar problems in the future do not occur. Due to the employees getting more work and paying even closer attention, it also improves the wellbeing of future hypertension patients as it is less likely that impure medications from Pfizer will make it out of distribution.

It is clear that Pfizer acted in the goodwill of the consumer, which, in turn, benefited all the stakeholders either directly or indirectly. Acting in the goodwill of the customer aligns concurrently with the Kantian ethical point of view. Pfizer acted swiftly and morally right which benefited everyone involved.

Virtue Theory

Looking at this case from the ethical beliefs within the Virtue Theory, Pfizer acted in an ethically correct way by recalling their contaminated products. The Virtue Theory was developed in the 4th century BC by Aristotle, a well known philosopher of the time and still to this day. This theory consisted of 4 important characteristics: courage, self-control/temperance, honesty, and fairness. Aristotle developed this theory to help his followers distinguish right from wrong. Virtue is attained by setting your eyes on a purpose and doing what is morally right to achieve that purpose. All 4 main characteristics of virtue theory are displayed with respect to each stakeholder. Each stakeholder is affected as follows:

High Blood Pressure Patients: The patients taking the medicine directly benefit from this recall. Pfizer was honest with the patients by informing them about the bad medicine they were taking. They were also courageous by issuing the recall as they did it regardless of the backlash they may receive from their patients. By giving the patients the option to change their medicine, they acted with fairness in mind. It is not fair to force someone to do something they may not want. Since they did not do that, they acted in the fairness of the consumer. Overall, all 4 characteristics of Virtue theory were displayed due to the fact that the company managed to issue the recall without causing much dysfunction. They issued the recall and managed self control by not releasing an excess amount of unneeded details.

Pfizer Shareholders: Pfizer shareholders more than likely will not be directly affected by the recall. Since the company was honest with its customers, they are improving their reputation. With an improved reputation, more people may begin to invest in the company. In turn, the price of the company may increase, directly benefiting the shareholders.

Doctors: The Doctors will directly benefit due to more customers looking to switch their medicine out or even to switch their medicine from the Pfizer company due to the impurities found inside. This will result in more business for the doctors, possibly causing a little stress but also causing an increase in sales from their end.

Manufacturers/Employees:

Action Plan

Nitrosamines found in these blood pressure medications are known carcinogens. Nitrosamines are also found in cured and grilled meats, dairy products, vegetables, and water. It is extremely difficult to completely avoid consuming nitrosamines when they are found everywhere. So, there is no immediate risk in taking these blood pressure medications. That means that using these medications for an extended period of time that high risk of cancer is a concern because of the long-term exposure to nitrosamine. This is not safe for patients who take blood pressure medications, like Accuretic. The company could change the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged, but there is still a possibility that as foods and drugs are processed in the body, nitrosamines can also be formed. The current issue here is that Pfizer should think about switching up their production method and not risk the health and safety of the patients who take these medication.

Authors:

        Kyle Dias

        Safia Muftic

        Maxwell Tavitian

References

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Center for Drug Evaluation and Research. “Information about Nitrosamine Impurities in Medications.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications

Center for Drug Evaluation and Research. “Pfizer Voluntary Nationwide Recall of Lots of Accuretic (Quinapril Hcl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril Hcl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content.” U.S. Food and Drug Administration, FDA, 22 Mar. 2022, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretic-quinapril-hclhydrochlorothiazide-quinapril-and.

“Drug Approval Package.” Accuretic (Quinapril HCI/Hydrochlorothiazide) NDA# 20-125, 31 May 2001, https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20125_Accuretic.cfm.

Dunleavy, Kevin. “In a Busy Month, Pfizer Extends Recall of Blood Pressure Meds to the UK.” Fierce Pharma, 29 Mar. 2022, https://www.fiercepharma.com/pharma/pfizer-extends-its-pull-back-blood-pressure-meds-uk-busy-month-recalls.

“FDA Announces Recall of Hypertension Medications Due to Potential Cancer Risk.” Cardiovascular Business, 8 Apr. 2022, https://www.cardiovascularbusiness.com/topics/heart-health/fda-recall-pfizer-hypertension-cancer-risk#:~:text=The%20FDA%20has%20announced%20that,an%20elevated%20risk%20of%20cancer

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“Nitrosamines.” Nitrosamines - an Overview | ScienceDirect Topics, https://www.sciencedirect.com/topics/neuroscience/nitrosamines

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

    For the past few decades, The United States of America has been plagued with an opioid epidemic. Purdue Pharma, the makers of OxyContin, have been known to be greatly contributing to this epidemic, if not causing it entirely. Recently, the company has been charged with several criminal charges, as well as made to pay billions of dollars in fines. As a part of the settlement that was reached, the Sackler family, who has owned the company since the 1950’s, will lose ownership of Purdue Pharma, as it is turned into a public benefit company. 

     All ethical theories would find several issues with the actions of Purdue Pharma. From an individualistic perspective, their actions were those of a typical business trying to maximize profit, however several violations of the law make their actions impermissible.  A utilitarian would also see several issues with this situation, as the biggest concern of utilitarianism is maximizing happiness for all. As will be outlined in this paper, not a single individual in this situation ended up with what one would consider to be happiness. From a Kantian perspective, several actions of Purdue Pharma are considered impermissible, particularly using people as a means to some end goal, as well as practicing manipulation of consumers. Finally, virtue theorist would find concern in the fact that almost all no virtuous traits were carried out by Purdue Pharma, but rather they practiced vices such as greed, dishonestly, and manipulation. 

    Although Purdue Pharma made several unethical mistakes in the marketing and distribution of OxyContin, there are things that can and should be done to fix this problem. By taking responsibility and showing that they have a desire to help those that they harmed, Purdue Pharma has the potential to improve their public image and regain the trust of Americans. 

Ethics Case Controversy 

 

Purdue Pharma's OxyContin, the meditation that has 
caused millions of deaths and led to the downfall
of the company. 

    Throughout the past couple of decades, the opioid crisis has become characteristic of the United States of America, and Purdue Pharma is being held responsible for creating it. The company has had to admit to “enabling the supply of drugs without legitimate medical purpose” (BBC), meaning that their only concern was selling their medication with no regard to whether it was done properly and safely or not. Recently, Purdue Pharma has been undergoing a federal investigation on the basis of lack of care involved in distributing OxyContin.  This has led to an $8.3 billion settlement to be reached. The settlement emphasizes that “for more than two decades, there has been a widespread problem of overprescribing, diverting, and abusing pain medication in America, while drug manufactures such as Purdue profited from this issue and failed to take responsibility or action” (Rowland). As part of this settlement, the Sackler Family, which has owned Purdue Pharma since the 1950’s, will not only lose ownership of their company, but will admit to “three felony counts for defrauding the federal government by misleading regulators about its efforts to restrict overprescribing of the drug and to violating anti-kickback laws by paying doctors to write more OxyContin prescriptions” (Williams).  A prime example of their wrongdoing was in 2012, when “members of the Sackler family demanded that company executives come up with a plan to generate greater revenue in response to slumping sales. A new marketing plan, called ‘Evolve to Excellence’ was created. This plan involved more intensified marketing of OxyContin to extreme, high-volume prescribers who were already writing ‘25 times as many OxyContin scripts’ as their peers.” (Rowland). While the company agreed to pay huge fines because of this as well as admit criminal liability, the family that owns the company, as well as executives within the company, claim that they "acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail” (Rowland). 

    This investigation has been ongoing for a substantial amount of time, however a settlement was just now reached due to the presidential election, but some are saying that it was far too rushed, and feel as if Purdue Pharma should have suffered more consequences for their actions. The Justice Department was pushed to settle a large number of outstanding cases involving major corporations, as “Administrations often seek to resolve significant cases as they near the possible end of their time in office, and with Election Day drawing near, the Trump administration has pushed to finalize a number of such matters this month” (Rowland). Massachusetts attorney Maura Healy stated that she believes that the Justice Department has failed, because “justice, in this case, requires exposing the truth and holding the perpetrators accountable, not rushing a settlement to beat an election” (Rowland). 

 

    The substantial amount of money that will be paid in this settlement will be used to redress past wrongdoings, as well as provide new resources for treatment and care of those impacted by OxyContin. Furthermore, Purdue Pharma will be turned into a Public Benefit Company, “meaning it will be governed by a trust that has to balance the trust’s interests against those of the American public and public health” (Balsamo). This comes as a relief to many, as the Sackler family has evidently caused an abundance of problems for the American public, and thus, they will no longer have control of their company. 

Timeline of Events 

 

Stakeholders

    There are countless stakeholders in this situation, including people who currently suffer or have previously suffered from addiction to OxyContin, the family and friends of people facing this addiction, the Sackler family, and the American population in general. People who have faced addiction to OxyContin largely have Purdue Pharma to blame, because if the medication was marketed and distributed properly, it’s likely that they would not have had a problem with it at all. Brooke Feldman, who is in recovery from opioid use disorder, stated that she “is glad to see Purdue admit wrongdoing. She said the company has acted for years as a ‘drug cartel’” (Balsamo). Many people who have faced addiction have lost a lot from this situation, including their jobs, relationships with family and friends, and some even losing their lives, which makes them one of the primary stakeholders in this situation. 

Protesters stage a "die-in" inside Harvard's
Arthur M. Sackler Museum to protest the Sackler's
involvement in the opioid crisis.

    Furthermore, families who are impacted by a member suffering abuse of the drug are also stakeholders, as many have lost someone they love due to the company’s wrongdoings. Ed Bisch, “who lost his 18-year-old son to an overdose nearly 20 years ago, said he wants to see people associated from Purdue prosecuted and was glad that the Sackler family wasn’t granted immunity” (Balsamo). Along with millions of others, Bisch blames the company and the family for the millions of deaths that have occurred, and has noted that “If it was sold for severe pain only from the beginning, none of this would have happened…but they got greedy” (Balsamo). 

    The Sackler family and other top executives are stakeholders because not only were they the decision makers in this case, but they also lost billions of dollars, as well as their company. Since they were the ones who chose to market their product aggressively, bribe medical professionals, and not take precautions to ensure the use of their product was safe and controlled, they ultimately made the decisions that made their company suffer. Because of that, and because they are also at a loss, they are considered stakeholders in this situation as well.

    Lastly, the American public are stakeholders in this situation as well. On top of having to be careful not to abuse OxyContin if they get prescribed it, Americans also have to watch people that they know and care about suffer from addiction. Many people, even if they are in severe pain, do not even want to get OxyContin prescribed to them because of how addictive it is. Since many have to live in fear, as well as watch many Americans suffer from OxyContin addiction, the general American public can be considered stakeholders in this situation as well. 

 

Individualism

    From an Individualistic perspective, there is wrongdoing involved with Purdue Pharma’s actions in the marketing and lack of responsibility in distributing OxyContin. Individualism, the theory created by Milton Friedman, emphasizes that “business actions should maximize profits for the owners of a business, but do so within the law” (Salazar 17). The aggressive marketing of OxyContin would not be seen as unethical from an Individualistic point of view, but rather beneficial to the company. The problem, however, is that Purdue Pharma used unlawful tactics in order to market their product. Purdue admitted to not only “violating federal anti-kickback laws by paying doctors to induce them to write more prescriptions, but also that it “impeded the Drug Enforcement Administration by falsely representing that it had maintained an effective program to avoid drug diversion and by reporting misleading information to the agency to boost the company’s manufacturing quotas” (Balsamo). Because they have violated several laws in order to make profit, this is not permissible under individualism. 

 

    Aside from the illegal aspect, the goal of their marketing was simply to maximize profit, which is the overall goal of Individualism. Since this theory is more so about the business and business owners rather than the consumers, there is nothing wrong with causing millions of addictions and deaths, according to Individualism. As long as the business is actively trying to maximize their profit, and doing so within the law, it is seen as permissible. 

 

    Although “Friedman held that it is the aim and the responsibility of businesses to maximize their

profits” (Salazar 18), Purdue Pharma was still in the wrong from an Individualistic point of view. Although consumers were undoubtedly harmed, that does not matter in and Individualistic sense, unless the law is broken. Since the marketing was not done within the law, however, this is not permissible under Individualism. 

Utilitarianism

    

    Utilitarianism emphasizes ‘maximizing the overall good’ or, in a slightly different version, of producing ‘the greatest good for the greatest number’. Acts that accomplish this aim are good; those that do not are bad” (Desjardins 29). This essentially means that the main goal is to maximize the happiness of everybody involved. 

    When Purdue Pharma was first beginning to sell OxyContin, their actions may have been seen as permissible under Utilitarianism. The Sackler family, as well as top executives in the company, were profiting off of selling this drug, which evidently causes happiness for them. Doctors were under the impression that the timed-release formula was meant to decrease the likelihood of addiction, so having a drug that reduced pain, while also having non-addictive properties, was seen as a great thing in the medical industry. Consumers, who had been dealing with severe pain before, were given a medication that worked well for reducing pain, which in turn made them happy. 

 

    Later on, however, almost everyone was hurt by this situation, meaning that it was shown to be unethical by Utilitarians. Consumers began facing addiction or even death due to OxyContin, meaning that family members were losing loved ones because of this drug. People who suffered from addiction were clearly not happy, and the risk of losing one’s life did not cause happiness either. Purdue Pharma was faced with incredibly large fines, as well as having to give up their business, meaning that he happiness from making profit did not last, and they ended up becoming unhappy as well. Since “business actions should aim to maximize the happiness in the long run for all conscious beings that are affected by the business action” (Salazar 17), and nobody remained happy in the long run, it becomes evident that the actions of Purdue Pharma were not permissible under Utilitarianism. Since almost everyone suffered in the long run and nobody came out of this situation with happiness, it can be seen that these actions are not beneficial to any of the stakeholders. This emphasizes that ultimately, the actions of Purdue Pharma were unethical by a Utilitarian point of view. 

 

Kantianism

    According the The Case Manual, the ethical rule of 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 17). Furthermore, according to Kant, “…ethics requires us to treat all people as ends and never only as means.” (Desjardins 38).  Purdue Pharma undoubtedly violated this, as they were using consumers as a means to the end goal of profit. The company did not care that people were becoming addicted to this medication at astounding rates, leading to millions of deaths across America, but rather they used this to their advantage, enabling them to sell more drugs and in turn, make more profit. 

    Although this situation is seen as ethically wrong in both Utilitarianism and Kantianism, it is wrong for different reasons. One of the key differences in the ethical theories 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). This essentially means that just because an action can produce good results, the action cannot be done based on only the outcome. Having Good Will, in this case, means that “…people

have good intentions and use good reasoning to come to conclusions that will 

make their good intentions effective” (Salazar 21). In the case of Purdue Pharma, it becomes clear that their intentions were only good for themselves, and not the consumers. They knowingly harmed millions of people in order to increase revenue, which ultimately benefitted only the Sackler family and top executives at the company. 

 

    One of the most concerning violations of Kantianism is one of the most important aspects of the theory, which emphasizes that the “fundamental ethical duty is to treat people with respect, to treat them as equally capable of living an autonomous life” (Desjardins 38). By continuing to aggressively market a drug that was known to be extremely addictive, Purdue Pharma was taking away people’s autonomy. Causing people to become dependent on a drug is one of the most clear-cut ways to manipulate people, as well as take away their autonomy. Once consumers become addicted, they keep needing more, which means that Purdue Pharma was making more and more profit off of people’s suffering. Because of this, it is evident that this case is extremely impermissible under Kantianism. 

 

Virtue Theory

    Similarly to Individualism, Utilitarianism, and Kantianism, the actions of Purdue Pharma would be seen as unethical by a virtue theorist. Virtue Theory, rather than focusing on individual actions, focuses on the character of individuals. The main objective of this 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 17), and it is evident that Purdue Pharma did not do that. 

 

    According to The Case Manual, “A few vices that have been severely detrimental to otherwise savvy and innovative business people are greed, dishonesty, and selfishness” (Salazar 23), and Purdue Pharma has demonstrated all of these. The company showed greed when they went to extreme measures to have their product become more popular. By convincing doctors to prescribe OxyContin more frequently, as well as going so far as to violate the law in order to make more profit, they have shown that they care more about profit than the health and wellbeing of consumers. Furthermore, dishonestly in this situation is rampant. On top of “defrauding the federal government by misleading regulators about its efforts to restrict overprescribing of the drug” (Williams), they have also lied about the dangers of the drug and its addictive properties, putting millions of people at risk. In terms of selfishness, Purdue has put gaining profit above the health of their consumers. They have expressed a selfish need for even more revenue than they already have, and rather than attempting to resolve the problem that they caused, they contributed to it even more. 

 

    Virtue theory values “Character Traits that Promote Wellness or Flourishing of Individuals within a Society.” (Salazar 22), and it is clear that Purdue Pharma does not promote wellness, but rather neglects it in an attempt to maximize profit. Because they marketed their product so aggressively and promoted the over-prescription of the drug, they were not promoting the flourishing of individuals within society, but rather the downfall. Because of all of the vices they have shown, as well as lack of virtuous characteristics, it is evident that a virtue theorist would view the actions committed by Purdue Pharma to be completely unethical. 

Justified Ethics Evaluation 

            In my opinion, Purdue Pharma’s actions were completely unethical. Not only did they harm millions and millions of people for the sole purpose of making profit, but they also did nothing to stop the epidemic that they created, but rather contributed to it even more. They were well aware that people had become extremely addicted to OxyContin, however, they continued to aggressively market the product, as well as bribe doctors to prescribe it abundantly. By implementing things such as “intensified marketing of OxyContin to extreme, high-volume prescribers who were already writing ’25 times as many OxyContin scripts’ as their peers.” (Rowland), Purdue Pharma put the health and safety of consumers at risk for the sole purpose of increased profit. Furthermore, they broke the law to do these things, by “defrauding the federal government by misleading regulators about its efforts to restrict overprescribing of the drug and to violating anti-kickback laws by paying doctors to write more OxyContin prescriptions” (Williams). Because of this, it is clear that Purdue Pharma made several ethical mistakes, which shows an abundance of negligence within the company. Not putting consumers first, but rather putting their lives at risk, is not ethical, and therefore Purdue Pharma acted completely unethical in this situation. 

 

Company Action Plan 

    It is evident that Purdue Pharma’s actions harmed millions of Americans. Because of this, there are several steps that must be involved in order to correct their wrongdoing. 

    First and foremost, the family and executives within the company need to accept their wrongdoing and admit to creating and contributing to the opioid epidemic. The family claims that they “acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail” (Rowland). This is evidently not true, and one of the first priorities when it comes to getting forgiveness from the general public is to admit that they did something wrong. Acknowledging their mistakes is the least that they can begin with doing. By doing this, they will show the American public, as well as those who have faced consequences from OxyContin, that they acknowledge their mistake and know that it was wrong of them.  

     As of now, Purdue is set to transform into a Public Benefit Company. One of the main purposes of this is “to ensure funding is devoted to advanced treatment programs” (Rowland), but also to ensure that the Sackler family will lose control of their company. Because of this, it will be impossible for the Sackler family to change the way they market and distribute OxyContin, since they will no longer have any part in it.

    One of the most important and potentially helpful things that the Sackler family can do to is donate money to families and communities that have been heavily impacted by the opioid crisis.  This is already a part of the settlement, since members of the Sackler family have already expressed a desire to “direct substantial funding to communities in need, rather than to years of legal proceedings…members of the Sackler family have expressed ‘deep compassion for people who suffer from opioid addiction and abuse and hope the proposal will be implemented as swiftly as possible to help address their critical needs’”(Williams). Despite the fact that this is already outlined in the settlement, it could be very beneficial for the Sackler family to donate some of their own personal money. This would not only improve the company’s public image, but it would show Americans that the family truly does care about how many people they have harmed, and are willing to give up part of the profit that they fought so hard for in order to help. 

    If the company wants to be able to remain profitable or be able to increase their profits, they would need to improve their public image and make sure that they are staying within the law. The Sackler family, however, will no longer have the ability to profit from the sale of OxyContin, since they no longer own the company. The Public Benefit company, however, must ensure that they are doing better than the Sackler’s in terms of marketing, distribution, and not violating the trust of the federal government and the American people. 

     Some of the values that need to be prioritized are trust, compassion, customer well-being, and honesty. Trust needs to be prioritized because it is one of the most important aspects of running a business. After the controversy, many Americans do not trust Purdue Pharma, and therefore the new company that will remain manufacturing OxyContin will need to regain this trust. The new company, as well as the Sackler family, needs to show compassion.  It was one of the main things that has been lacking for decades, and ensuring that businesses care about the people that they are supplying to is important, and it helps build trust. After all of the company has done, they need to show compassion and prove to Americans that they have learned from their mistakes. Customer well-being is the most important of all of these values. Because they are pharmaceutical company, that should be their first priority, however it wasn’t while the Sackler family owned it. The new Public Benefit Company, as well as the Sackler family, even after losing their company, need to show that they do care about the well-being of their customers. If that does not happen, then the company will not be able to flourish, and the Sackler family will remain in bad view from the public. Lastly, honesty is important in any business, but pharmaceutical companies especially. Pharmaceuticals have the power to kill people, create addictions, and cause many adverse effects. Companies need to be honest with not only their customers, but the government as well. It needs to be apparent to customers that the company has the well-being of customers as the first priority, and will not practice dishonesty to deceive customers for the purpose of profit. 

 

     If the Sackler family follows these steps of publicly apologizing, donating money to families and communities that were impacted from OxyContin, and keeping their values aligned, the company has a chance of greatly improving their public image, and potentially gaining the trust of Americans back again. Although it will be hard for them to be completely forgiven, taking steps towards this goal is important. If the family and the company do nothing, then they will be seen as even worse than they already are. 

     It is apparent that Purdue Pharma has made mistakes in the marketing and distribution of their product, OxyContin, that are considered to be extremely unethical. Not only did the company break several laws and lie to the federal government, but they also knowingly contributed to the opioid epidemic that has been controlling America for decades. Many, if not all, of Purdue Pharma’s actions were done for the sole purpose of increasing profits to extremely high amounts, however, they prioritized this over the lives of consumers. When looking at the situation from an Individualistic approach, almost everything is permissible, except for the fact that they broke the law. The ethical theory essentially states that businesses can do whatever needs to be done in order to maximize profit, as long as it is within the law. Because of that, it is obvious that this is impermissible under Individualism. In the sense of Utilitarianism, it is obvious that not everybody is happy in this situation. Not only are there millions of Americans suffering from addiction to OxyContin, but also family members and members of the community are drastically affected from that as well. Furthermore, the Sackler family ended up losing their company and having to pay billions of fines, so they are evidently not happy either. When preparing an analysis from a Kantian perspective, it becomes apparent that this is also impermissible, Purdue Pharma used customers as a means for increasing profits, and harmed them in the process. Lastly, a virtue theorist would also disagree with these actions. They are not practicing virtues that make businesses and people flourish, but they are instead practicing vices such as greed and dishonestly that harm people. Despite the fact that Purdue Pharma made a huge mistake and harmed the American people, there are steps that they can take to make things right. By taking full responsibility for their actions, as well as showing that they regret what they did by making monetary donations to those who have been affected, Purdue Pharma and the Sackler family has the ability to repair their public image, as well as potentially gain the forgiveness and trust of the American people. 

 

                                                                                                           Julianne Hess

 

 

 

 

 

References

 

Balsamo, Michael, and Geoff Mulvihill. “OxyContin Maker Purdue Pharma to Plead to 3 Criminal Charges.” AP NEWS, Associated Press, 21 Oct. 2020, apnews.com/article/virus-outbreak-business-criminal-investigations-opioids-epidemics-5f0679ffee14577b1696a94b64abc9c2.

DesJardins, Joseph R. An Introduction to Business Ethics. McGraw-Hill/Irwin, 2014. 

Ofgang, Erik. “Purdue Pharma and OxyContin: A Timeline.” Connecticut Magazine, 24 Oct. 2019, www.connecticutmag.com/health-and-science/purdue-pharma-and-oxycontin-a-timeline/article_e140534a-f50f-11e9-96ab-8bb2725250e0.html.

“OxyContin Maker Purdue Pharma to Plead Guilty to 3 Criminal Charges.” CBS News, CBS Interactive, 21 Oct. 2020, www.cbsnews.com/news/oxycontin-maker-purdue-pharma-to-plead-guilty-3-criminal-charges-ap/.

Rowland, Christopher, and Meryl Kornfield. “Purdue Pharma Agrees to Plead Guilty to Federal Criminal Charges in Settlement over Opioid Crisis.” The Washington Post, WP Company, 22 Oct. 2020, www.washingtonpost.com/national-security/2020/10/21/purdue-pharma-charges/.

Salazar, Heather. The Case Manual . 

Sherman, Natalie. “Purdue Pharma to Plead Guilty in $8bn Opioid Settlement.” BBC News, BBC, 21 Oct. 2020, www.bbc.com/news/business-54636002. 

Williams, Pete. “OxyContin Maker Purdue Pharma Pleads Guilty to Federal Criminal Charges.” NBCNews.com, NBCUniversal News Group, 22 Oct. 2020, www.nbcnews.com/news/us-news/oxycontin-drugmaker-purdue-pharma-pleads-guilty-federal-criminal-charges-n1244155.