Monday, April 3, 2017

Statins: A Justified Injustice

Pfizer Statins:  A Justified Injustice (2015/2016)

Based on a paper by Spencer Goodman
Summary by Spencer Goodman

Pfizer's blockbuster drug Lipitor
Lipitor, the best-selling drug in the history of pharmaceuticals, is the blockbuster that almost wasn’t.  When it was in development, the cholesterol-lowering medicine was viewed as an after-thought.  By the time Lipitor went on sale in early 1997, it was the fifth drug in a class called statins that lower LDL or bad cholesterol. The class already included three blockbusters, drugs with sales of $1 billion a year or more.  Being that it was a late addition to a staked group of statin-based drugs it seemed as if Lipitor would not be a success.  But a 1996 study showed Lipitor reduced bad cholesterol dramatically more than the other statins, from the very start of treatment and even more so over time. A striking graph of those results helped Lipitor sales representatives turn it into the world’s best-selling drug ever, with more than $125 billion in sales over 14 1/2 years (Johnson).

Statins are prescribed in order to lower the cholesterol of the patient, but a recent controversy stated that they were harmful for the patients’ health.  It was then found out by a more recent medical study that statins are not in fact harmful to the patients well-being.  The risks of taking statin based drugs are outweighed heavily by the benefits.  Initially an international team of scientists reviewed 19 previous studies, involving 68,000 people (Independent), and said they found no link between high levels of LDL cholesterol, the so-called “bad cholesterol”, and heart disease in the over-60s.  Too much weight had been placed upon unreliable evidence from observational studies, while the results from randomized drugs trials, which are reliable, had not been properly acknowledged.  The review found that side-effects can include developing muscle pain, diabetes or a hemorrhagic stroke, but suggestions that statins cause other conditions, such as memory loss, cataracts, kidney injury, liver disease, sleep disturbance, aggression or erectile dysfunction, are not accurate.


Cartoon showing negative patient reactions to being prescribed Lipitor
Stakeholders are any person, organization, animal, etc... that is effected by the company's actions.  For one to truly understand the effectiveness of false data when it comes to being a stakeholder, they have to put themselves in the stakeholders position.  Stakeholders potentially have millions of dollars invested in a company and whether the company succeeds could be the reason the stakeholders family has food on the table.  When the news broke that statin-based drugs could be damaging to a persons health many stakeholders were affected.  Pfizer stockholders withdrew a large portion of their stock fearing that the drug would be called off the shelves.  But more importantly those who were prescribed Lipitor stopped taking the medication.  It has been researched that over 200,000 patients stopped taking their prescribed statin-based drugs after the data was released (Gasse).  This could have resulted in many patients with bad cholesterol suffering from complications because they were not taking their medications.  The doctors who prescribe such statins are also considered stakeholders 


Individualism is egoism (selfishness) plus rights-based constraints.  Friedman's Individualism discusses the idea of a businesses only goal is to generate profit, the only obligation of the businessperson is to maximize profit for the stockholder within constraints of the law.  Under Friedman's Individualism Pfizer made the correct choice by not taking Lipitor off the shelf because this would have resulted in a loss in profit.  There were no legal ramifications by leaving the product available for purchase and there was no action made by the Food Drug Administration (FDA).  This shows that Pfizer was individualistic and ethically sound in this scenario when handling the false data reports.  The scientist who were behind the research that led to hundreds of thousands of patients not taking their prescriptions could be viewed as unethical.  This is due to the scientist potentially releasing this data for personal gain although the data was false.  


Pfizer headquarters in Conn., USA
Utilitarianism is the search for what makes things good in ethics.  It is the search for intrinsic value within an ethical case.  The desire to be happy is basic and requires no further justification.  Utilitarianism attempts to maximize happiness in yourself and others (Salazar).  If happiness is valuable, there is no difference morally speaking between two people's happiness.  Pfizer attempted to regain the happiness of it's patients by urging them to continue to take their medications, but the power of negative publicity was too much.  Patients still refused to finish the rest of their prescriptions in order to maintain a lower cholesterol.  The scientist released the data did not have others happiness involved in making the decision to falsify data that could lead to heart complications for those who were prescribed statin-based drugs.  Pfizer made it a mission to uphold their stakeholders happiness and attempt to rid the corrupted data that could cost thousands of people their lives.  There was no selfishness in Pfizer's argument that their statin drug had negative side effects, they were correct and stood by what they believed in making them ethically correct in utilitarian means.  In the end there was more happiness because of a new study that found Lipitor and other statin-based drugs did not have extremely harmful side effects. 


Kantianism makes sure that everyone is knowledgeable during an ethical situation.  Stakeholders and the public must know all the details that occur throughout the case.  Acting rationally is a business's bread and butter when it comes to Kant.  Businesses should not consider themselves exempt from rules and must respect people and their individual needs.  Pfizer sought to do what is right because they knew they were right.  Pfizer was not going to let a false study ruin their chance of making people's lives better and increasing the chances of a healthy life for their consumers.  Pfizer wanted to treat people how they themselves wanted to be treated.  The formula of humanity states that one should "act in such a way that you treat humanity....".  This formula comes down to an organization not dehumanizing someone.  As soon as a company does this they are unethical from a Kantian perspective,  Pfizer did not treat people as a mean in order to gain profit.  Pfizer treated it's consumers as an end because they wanted to help them for their own sake, they wanted to help treat their condition.  Pfizer did not with hold any information and stood beside it's statin-based drug because they knew it was beneficial to humanity.  

Virtue Theory:

Pfizer CEO Ian Read

Virtue theory was developed by Aristotle. “All of the character traits that we say belong to people can be virtues or the opposite of virtues, which are called vices” (Salazar 23).  The four virtues in business are courage, honesty, temperance, and justice.  Pfizer displayed all of these during the statin controversy.  It took courage to leave Lipitor available for purchase and for Pfizer to convince physicians to continue to prescribe it.  Pfizer was honest and stood by their product knowledge.  There was no falsifying data observations.  Pfizer maintained temperance by not lashing out at the doctors who conducted the study that produced false data.  They acted in a calm manner and supported their stakeholders and themselves by issuing the public in a professional voice.  There was justice for Pfizer in the long run as this data was proven to be incorrect and statin-based drugs were very effective and had the ability to save lives.  

Action Plan:

Pfizer dealt with the statin controversy in an effective and professional manner.  They continued to sell their product which showed confidence and that they truly cared about the customers well-being.  Pfizer should continue this customer appreciation in other products as well to explore creative marketing projects that relate to the importance of humanity.  Designing products to show the public that Pfizer treats humans the way they should be treated could have a long-lasting impact on Pfizer's brand image.  Stakeholders would be satisfied with the caring nature of Pfizer's new marketing plan and continue to support the organization.  

Justified Ethics Evaluation:

All in all, the statin controversey caused much distress in company's that provided statin-based drugs to consumers.  Pfizer was forced to react to an unexpected products that had been a huge success in the past.  The organization did everything to ensure their blockbuster drug was safe for consumption and earned the trust of physicians and their patients.   

References Cited:

Köhler, O., Gasse, C., Petersen, L., Ingstrup, K. G., Nierenberg, A. A., Mors, O., & Østergaard, S. D. (2016). The effect of concomitant treatment with SSRIs and statins: A population-based study. The American Journal Of Psychiatry, 173(8), 807-815. doi:10.1176/appi.ajp.2016.15040463

Ling, Q., & Tejada-Simon, M. V. (2016). Statins and the brain: New perspective for old drugs. Progress In Neuro-Psychopharmacology & Biological Psychiatry, 6680-86. doi:10.1016/j.pnpbp.2015.11.013

Gitsels, L. A., Kulinskaya, E., & Steel, N. (2016). Survival Benefits of Statins for Primary Prevention: A Cohort Study. Plos ONE, 11(11), 1-14. doi:10.1371/journal.pone.0166847

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