Tailor Made Compounding is a company who has always worked in categories like anti-aging, sleep solutions, and aesthetic dermatology - until recently. With the hysteria of COVID-19 providing an opportunity for pharmaceutical companies to profit significantly from any progression in vaccines or treatments, Tailor Made Compounding seized the opportunity. However, the way they took advantage of this opportunity was nowhere near ethical. For one, their research and compounding never had to do with infectious diseases and for them to take something on like this was well beyond their reach. They made claims that their compounding was a safe and FDA approved treatment for COVID-19 when the FDA had never approved their treatment and it was never proved to actually have any success in treating the virus. Many laws protect the general public from money-hungry companies like this but it took some time and probing from the subcommittee of Economic and Consumer Policy and outrage across the country for there to be an official investigation done by the FDA and FBI. As a result of this investigation, CEO of Tailor Made Jeremy Delk was sentenced to 10 years and the company was required to pay a maximum fine of $250,000. Because of Tailor Made’s actions many people went about their lives thinking they were immune to COVID-19 when in fact they could have been the most dangerous people to be in contact with since they were likely taking significantly less precautions to stay safe and/or stop the spread of the virus.
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| COVID-19 |
When it comes to ethical theories, the theory of Individualism argues that any company/person should be able to maximize their profits as much as they want as long as it is within the bound of the law. Because making claims that the FDA had approved of the treatment and making unsupported claims about the drug in general are highly illegal, an Individualist would be against Tailor Made Compounding and would agree with punishing the company. A Utilitarian perspective aims for maximum amounts of happiness for everyone. Because these people are having to pay significant amounts of money for something that is not actually working or keeping them safe, it does not make them happy and their amounts of unhappiness significantly outweigh the few people at the top of Tailor Compounding who are profiting. A Kantian theorist would say that everyone should be treated as ends in themselves and not just means to an end. Because Tailor Made Compounding lied and manipulated these people to profit off of them, a Kantian would think Tailor Made was acting unethically. And finally from an analysis of the vices and virtues of the company - Tailor Made Compounding exhibited vices such as greed and dishonesty and lacked in critical values such as compassion and caring. In moving forward, the company will have to do some heavy damage control including an outright apology to the public for their misleading treatment advertising and should make sure to hire someone at the top of the company that has strong values of anti-corruption and anti-corporate greed.
The Case:
As the coronavirus continues to spread across the United States it endangers the lives of millions. Alongside that the paranoia and fear of catching it is on the minds of most Americans as they proceed in their daily lives as cautiously as possible. It is not a surprise that the people of America are extremely susceptible to the tricks and follies that are bound to be pulled by unethical companies that are attempting to profit off of the uncertainty of the virus. Web of Wellness Doctors leaped at this opportunity, Tailor Made Compounding being one of, “30 medical practices and compounding pharmacies across more than a dozen states that have made unproven claims about this drug on their websites and on social media.” (Dreisbach) The cost of these drugs can run up and around $400 for only a month’s supply - all of which comes completely out of pocket. While representatives from VitaLifeMD have made claims regarding potential treatments, Tailor Made has made far more explicit claims for thymosin alpha-1 as a COVID-19 treatment. In early March a company leader from Tailor Made, Ryan Smith, created a presentation where, “He told a group of health care providers that Tailor Made Compounding had several drugs that they could "sort of market to your patients" during the pandemic [and] repeated the falsehood that thymosin alpha-1 is "FDA approved," and he recommended the drug to his audience as a treatment for Lyme disease, "general anti-aging," as well as the coronavirus.” (Dreisbach) Tailor Made Compounding took advantage of the citizens of the United States of America who are fearing for their lives in the midst of a global pandemic. Tailor Made lied to their clients and endangered their lives by giving them a false sense of security.
In a letter from the subcommittee on Economic and Consumer Policy, they inquire about the efforts being made by the FDA and the FTC in regards to the sale, distribution, and prescription of the drug thymosin alpha-1 for treating COVID-19. They explain that the efforts done so far, just warning companies that their actions are unlawful, is not enough. It explains that these companies aren’t even experts in infectious diseases, instead they often deal with benign treatments such as plastic surgery or even anti-aging medicine. Creating a cure to a pandemic that is crippling nations all across the world, does not really seem like it is in their alley of expertise. On June 30th these warnings went out to companies but this subcommittee argues that is not enough. There are many dangers in permitting companies to proceed in offering thymosin alpha-1 to people as a treatment for COVID including: “People who take them and assume they are protected risk infecting others. Beyond that, scam sales of this product present significant economic harm to consumers.” (House Committee) So clearly not only is this an obvious abuse of power to charge people exorbitant amounts of money for something that is not even FDA approved, it also makes people feel like they are immune to COVID which can cause people to not be as cautious as they should be. Specifically, Tailor Made received a warning from the FDA for unsafe production processes on April 1, 2020. However, warning letters carry no penalty and there is nothing being done to actually stop these companies from carrying on these dangerous practices. The Subcommittee ends the letter demanding that the FDA and FTC enforce existing laws to eliminate the sale, distribution, and prescription of the drug thymosin alpha-1 for treating COVID-19 and to open an investigation into this malpractice.
Fortunately for the people of the world, Tailor Made Compounding faced the scales of justice and lost. On October 29th, “Tailor Made Compounding LLC (TMC) pleaded guilty to one count of distributing unapproved new drugs throughout the United States, from October 25, 2018 through April 1, 2020, before the U.S. District Judge Gregory F. Van Tatenhove. Specifically, TMC pleaded guilty to unlawful distribution of selective androgen receptor modulators (“SARMS”) and other substances that the FDA had not approved for distribution in the United States.” (“Nicholasville Compounding…”) Clearly after the investigation and demands put forth by the Subcommittee of Economic and Consumer Policy, serious action was taken and Tailor Made Compounding faced their consequences. The United States Attorney for the Eastern District of Kentucky is quoted explaining that it is of paramount importance to make sure that companies follow all FDA requirements. He writes that, “When pharmacies intentionally evade the FDA requirements, they are placing their own interests above those of the patients they are supposed to be serving. The community deserves better, and I commend the work of our law enforcement partners in their diligent efforts to protect the public and disrupt this criminal conduct.” (“Nicholasville Compounding…”) He then goes on to explain that while compounding drugs are important to fulfill the needs of patients for whom normal drugs don’t work, it is still important to make sure that these drugs are fitting the important criteria necessary to ensure the safety of those that are consuming the drugs and are not taking advantage of people who are entrusting these companies literally with their lives. Delk faces up to 10 years in prison and a maximum fine of $250,000 for his actions in allowing Tailor Made to continue as they were. One can hope that this case and the punishments received from the unlawful actions, will set an example for those who are thinking of following down the same path and will discourage them from endangering the public in this way.
These false claims also endanger the consumers in another very real way. In an article by the FDA they express a lot of concern regarding how these fraudulent claims are actually affecting the safety of people, “The FDA is particularly concerned that these deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. It’s likely that the products do not do what they claim, and the ingredients in them could cause adverse effects and could interact with, and potentially interfere with, essential medications.” (Commissioner) So not only are these fraudulent claims taking advantage of a consumer through profiting off of something that it doesn’t actually do, these medications could really hurt the people they are giving them to through reactions to the medication.
There has been progress since these fraudulent claims in finding a treatment for COVID-19 that is actually FDA approved. Bamlanivimab was approved by the FDA through an issuance of an emergency use authorization which skips some of the stringent time requirements usually necessary for certain drugs approvals. They detail that they recognize that they think it is worth using these treatments without knowing all the side effects and long term effects since they are using it on people who will likely die without any treatment at all. Dr. Prince writes, “they also have to fall into a category of risk that’s been identified as placing them at a higher risk for hospitalization and bad outcomes like death.” (Briar) The interesting part of this which definitely makes it more ethical and differentiates these practices from those of Tailor Made Compounding is that they are not charging the patients for the medication - so it is all free. Selection of patients is done after a review of patients symptoms and circumstances, much unlike Tailor Made who just sold it to whoever could afford the steep prices.
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| Bamlanivimab |
Stakeholders:
The stakeholders in this case are the Tailor Made executives, the CEO of Tailor Made - Jeremy Delk, the American public, shareholders, and Tailor Made employees. The two most important ones that are truly emphasized in this case and in its ethical analysis are Jeremy Delk and the American Public. Jeremy Delk held a large stake in this because he stood to gain a lot of money from his actions. The American Public had a lot to gain in the sense of safety but in reality lost a lot in this situation by being lied to.
Individualism:
When it comes to being the devil’s advocate, an Individualist would likely play the best actor in that role. They argue that individuals and companies are well within their rights to act as they please and maximize their profits to any extent as long as it is within the bounds of the law. In other words, things may seem morally wrong but as long as the actions aren’t breaking any laws then an Individualist would say it is totally okay for them to be doing the immoral action. This one looks at situations in black and white and there really isn’t a gray area like there is in other ethical theories. Either the actions are legal or they aren’t and that determines the verdict of whether it is okay or not. So it is very telling to know that an individualist would argue that Tailor Made Compounding’s actions were unethical. Lying about FDA approval is a federal crime. There are many laws that regulate the selling of drugs and TMC broke several of these laws which makes them unethical according to an individualist.
Utilitarianism:
A Utilitarian on the other hand gets a little more complicated in the sense that there are more factors and people to consider when analyzing whether a situation is ethical or not. From a Utilitarian perspective, they seek to maximize happiness as much as possible. So even though one person might be happy that is not enough if there are 20 other people who are very unhappy. Therefore in this instance, a utilitarian would argue that Tailor Made Compounding was acting unethically. This is because though Jeremy Delk and his executive board would profit significantly from the sale of this alleged COVID treatment/drug, the unhappiness of their customers and the American public as a whole would greatly outweigh their happiness. If someone has to pay $400 for a drug that doesn’t even work, they would immediately be extremely unhappy for wasting their money. On the next level, this lie that it works puts them in great danger since they start to assume they are immune and not taking the precautions that they should be to keep safe. This can lead to their own death, death of loved ones, and death to anyone they encounter. The unhappiness that comes from death most definitely outweighs the happiness of a few people at the top of Tailor Made Compounding who profit from the sales of this false COVID treatment.
Kantianism:
A Kantian ultimately believes that everyone should be treated as ends in of themselves and should not be used as means for the ends of someone else. This means not manipulated, or lying to anyone in order to achieve a personal goal. In this sense a Kantian would also think that the actions of Tailor Made Compounding were unethical since Jeremy Delk and his company lied to people when they said that this drug treated COVID and was approved by the FDA when both claims were very wrong and unsupported. Jeremy Delk used the American public and endangered them in order to make as much money as possible.
Virtue Theory:
The great Greek Philosopher Aristotle brought forward Virtue Theory which analyzed the characteristics of individuals rather than looking at a general situation. It considers values like courage, honesty, leadership, compassion, integrity, and more. It also considers the vices that one might hold like greed and selfishness. In these actions, Tailor Made Compounding displayed vices such as greed and selfishness and lacked key virtues such as honesty, compassion and integrity. They lied to their customers and were not honest, they were not compassionate since they first of all charged such high prices and second endangered their lives with these false claims. They were simply greedy and wanted to make as much money as possible without considering how everyone else would be affected.
Justified Evaluation:
After looking at all of the ethical theories and research, they all come to the consensus that Tailor Made Compounding acted unethically in the selling and marketing of their drugs that they claimed could treat COVID-19. I agree with this consensus. I think it is extremely wrong of Tailor Made to take advantage of the people of the world who anxiously await good news of a vaccine or treatment so that they can stop living in fear of catching this infectious disease or even passing it along to a loved one. It is so wrong to play on the little hope that the people of the world have just to make extra money. While people are losing their jobs and homes because of this pandemic, Tailor Made Compounding made these horrible claims that they had a treatment for the virus just to make so much more money. Instead of being grateful for holding onto the income they already had, they had to take advantage of the little money and hope that Americans are left with today. What Tailor Made Compounding did was so wrong on so many levels and it is without a doubt that I say the actions they did deserve the most severe punishment possible.
Action Plan:
At this point the only thing that Tailor Made Compounding can do is apologize for their actions and start fresh. They should immediately hold a press conference of some sort to apologize to the American people for lying to them and taking advantage of their hope. Perhaps they can justify their actions by saying they too strongly had hope for the compounding drugs and simply got ahead of themselves in the process. They could say that they truly believed they could help the American public go back to normal just as they so desperately want to. They would have to admit complete fault and recognize that they were very wrong. One thing I strongly believe they have to do is repay those individuals who bought the drugs and even pay them reparations for any harm they brought to their families or friends since they thought they were safe. If they want to remain profitable it will be important to explain that their intentions were pure and that they simply were so eager to help everyone that they got caught up and couldn’t wait for any approval. This can be done through the aforementioned recommendations.
Julia S.
References:
Briar, Chelsea. “Revolutionary New COVID-19 Treatment Arrives in Madison County.” Local News 8, 13 Nov. 2020, localnews8.com/news/local-news/2020/11/13/revolutionary-new-covid-19-treatment-now-in-madison-county/.
Commissioner, Office of the. “There Are No FDA-Approved Drugs or Vaccines to Treat COVID-19.” U.S. Food and Drug Administration, FDA, www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments.
Dreisbach, Tom. “Web Of 'Wellness' Doctors Promote Injections Of Unproven Coronavirus Treatment.” NPR, NPR, 1 Oct. 2020, www.npr.org/2020/10/01/914433778/web-of-wellness-doctors-promote-injections-of-unproven-coronavirus-treatment
House Committee on Oversight and Reform, oversight.house.gov/ .https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2020-10-28.RK%20to%20FDA%20and%20FTC%20re%20Thymosin%20Alpha-1.pdf
“Nicholasville Compounding Pharmacy and Its Owner Plead Guilty to Unlawful Distribution of Prescription Drugs.” The United States Department of Justice, 29 Oct. 2020, www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution.
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