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.
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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.
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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”.
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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.
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References
“Accuretic (Quinapril Hcl/Hydrochlorothiazide): Uses, Dosage, Side Effects, Interactions, Warning.” RxList, RxList, 1 Sept. 2021, https://www.rxlist.com/accuretic-drug.htm
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
FDA's role in drug recalls. (n.d.). Retrieved April 15, 2022, from https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls
“History of Pfizer.” Pfizer, https://www.pfizer.com/about/history
Holcombe, M. (2022, March 24). Blood pressure medication recalled over cancer risk concerns. Retrieved April 12, 2022, from https://www.cnn.com/2022/03/23/health/pfizer-blood-pressure-medication-recall-wellness/index.html
Jewett, Christina. “Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk.” The New York Times, The New York Times, 23 Mar. 2022, https://www.nytimes.com/2022/03/23/health/pfizer-recall-blood-pressure-drug-cancer.html.
Lee, Bruce Y. “Pfizer Recalling 3 Blood Pressure Medication Types Due to Cancer Concerns, FDA Says.” Forbes, Forbes Magazine, 14 Apr. 2022, https://www.forbes.com/sites/brucelee/2022/03/26/pfizer-recalling-3-blood-pressure-medication-types-due-to-cancer-concerns-fda-says/?sh=183003ba5811.
Lou, Nicole. “Another Class of Antihypertensive Recalled.” Medical News, MedpageToday, 25 Mar. 2022, https://www.medpagetoday.com/publichealthpolicy/publichealth/97883.
Newsy. “Pfizer Recalls 3 Blood Pressure Drugs Due to Cancer Risk.” WFTS, WFTS, 23 Mar. 2022, https://www.abcactionnews.com/news/national/pfizer-recalls-3-blood-pressure-drugs-due-to-cancer-risk.
“Nitrosamines.” Nitrosamines - an Overview | ScienceDirect Topics, https://www.sciencedirect.com/topics/neuroscience/nitrosamines
“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.” Pfizer, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntary-nationwide-recall-lots-accuretictm
Romo, Vanessa. “Pfizer Launches a Recall of Blood Pressure Drugs Due to a Potential Carcinogen.” NPR, NPR, 22 Mar. 2022, https://www.npr.org/2022/03/22/1088075045/pfizer-blood-pressure-recall-carcinogen
Salazar, Heather. Kantian Business Ethics. N.d.
Salazar, H. The Business Ethics Case Manual. N.d.
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