Tailor Made Compounding: Fraudulent Drug Claims (2020)

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. 

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.

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.

VitaLifeMD: Encouraging Use of Untested Coronavirus Treatments (2020)

            In the midst of the coronavirus pandemic, as fears are heightened and illness is spreading rapidly,  VitaLifeMD in Los Angeles claimed to have the miracle COVID-19 treatment that consumers were desperate for. VitaLifeMD asserted on social media that they had “one of the best ways to prevent and fight COVID-19”: a drug known as thymosin alpha-1, and began prescribing it to patients (Dreisbach). Within the claims, they were providing falsified information to consumers, declaring that thymosin alpha-1 was FDA approved and an effective treatment for COVID-19, when in fact there is only one FDA approved treatment for COVID-19, Remdesivir, and the FDA has not declared that thymosin alpha-1 is an effective treatment for COVID-19 (Dreisbach)(Harvard Health Publishing). From an Individualist perspective, VitaLifeMD was unethical as they obtained profits through illegal activity, providing misleading marketing to consumers and making false claims regarding the FDA. Utilitarians would agree, as in the long-run, use of thymosin alpha-1 as a preventive measure against COVID-19, rather than social distancing or wearing masks, potentially exposes more individuals to the coronavirus through a false sense of security, and therefore decreases the happiness of a larger amount of people. A Kantian would declare this act unethical as there was disregard for the rationality of consumers through the use of false claims. From a Virtue Theorist’s perspective, VitaLifeMD lacked the virtues of courage, honesty, temperance, justice, and prudence through the encouragement of thymosin alpha-1, therefore acting unethically in this case. VitaLifeMD needs to direct their efforts to ensuring that consumers are their number one priority, providing them with safe, reliable, transparent, and innovative ways to enhance their health. I believe new policies and staff would support VitaLifeMD as they will continue to grow as a company and develop long lasting relationships with consumers. 

ETHICS CASE CONTROVERSY

            As the new year progressed, the United States was faced with a newfound issue: what to do to control an unprecedented virus that is claiming the lives of hundreds every day. The first confirmed case of the novel Coronavirus in the United States arrived in January 2020. Just two months later, March 2020 reflected a time of great fear, as the Coronavirus was exploding at a rapid pace, filling up hospitals, and destroying families. This surge of cases provoked President Donald Trump to declare a National Emergency as the World Health Organization announced COVID-19 as a pandemic (AJMC Staff). With the lack of information known about COVID-19 and the novelty of the virus, there was no treatment, vaccine, or preventive measure in place when the Coronavirus changed the way of life for individuals across the world. To this day, clinical trials are still taking place. However, there is no approved vaccine and Remdesivir remains the only FDA approved treatment (Harvard Health Publishing). 

Tweet about Thymosin Alpha-1 by VitaLifeMD.

            While COVID-19 continued to disrupt families and spread through communities, the need for a trustworthy treatment and cure was being sought out by individuals seeking relief. Quickly, VitaLifeMD, owned by Dominique Fradin-Read in Los Angeles, claimed to have “one of the best ways to prevent and fight COVID-19”: a drug known as thymosin alpha-1 (Dreisbach). Fradin-Read is a well-respected individual in the wellness community, specializing in vitality medicine, “a personalized, integrative approach to health, beauty, and wellness” (VitaLifeMD). The individuals in these wellness communities “are not specialized in infectious diseases but rather focus on plastic surgery or promote ‘wellness’, ‘anti-aging’, and ‘regenerative medicine’” (Dreisbach). Nevertheless, to connect with consumers, VitaLifeMD relies on the use of social media, Instagram, Twitter, and Facebook, and used the platforms to provide Americans with their treatment discovery. An NPR investigation revealed that VitaLifeMD claimed to “have an ‘FDA approved’ medicine that worked like ‘magic’” (Dreisbach). Tom Dreisbach declared, “if patients followed [the] advice, including getting regular injections of this drug, [Fradin-Read] said ‘maybe the virus will not be that hard to fight’” (Dreisbach). These claims can be considered to be misleading and a way that VitaLifeMD is putting individuals at risk, as “the drug, thymosin alpha-1, has never been approved by the Food and Drug Administration for any condition, nor has it been proven safe or effective for treating COVID-19” (Dreisbach). As a result of this newfound investigation, it has been revealed that VitaLifeMD is but one of at least "30" medical practices and/or compounding pharmacies in the United States who have been making false claims about this "treatment" on the Internet (Dreisbach).  It has been exposed by NPR that multiple companies have prescribed thymosin alpha-1 to at least “100 patients” with out-of-pocket costs nearly “$400” for a one-month supply (Dreisbach). 

            VitaLifeMD believes that this drug is safe and useful, as Fradin-Read herself has not noticed any adverse side effects among the patients who have taken it so far (Dreisbach). While thymosin alpha-1 has been studied as a potential treatment for other diseases, the drug has been granted “orphan drug designation”, and the FDA “has never granted thymosin alpha-1 approval for treating any condition” (Dreisbach). Due to the lack of FDA approval, the drug is unable to be sold as a commercial product. VitaLifeMD has been utilizing compounding pharmacies, including Tailor Made Compounding, of which are not subject to the same regulations as typical pharmacies (Gavura). These compounding pharmacies are allowed to manufacture “drug products not otherwise commercially available” and many of these products are not tested by the FDA for safety or quality standards (Gavura). Tom Dreisbach emphasizes, “experts say the claims about thymosin alpha-1 show how some doctors can misuse patient’s trust to help create a market for drugs that haven’t been proven to work” (Dreisbach). As a result, the FDA and FTC have been getting involved with these false claims about COVID-19 treatments.

            Since March 2020, VitaLifeMD has made multiple social media posts regarding thymosin alpha-1. In one instance, VitaLifeMD was hosting an Instagram Live video where they explained their discovery, thymosin alpha-1, from Tailor Made Compounding. While promoting the drug to consumers on this video, they referred to Tailor Made Compounding as “one of the best pharmacies” (Dreisbach). VitaLifeMD began posting on Facebook, Instagram, and Twitter about thymosin alpha-1, claiming it to be “one of the best ways to prevent and fight COVID-19” (Dreisbach). As mentioned earlier, on these platforms, they declared that she had an “FDA-approved” medicine that she believed worked like “magic” (Dreisbach). Nevertheless, the FDA has not given thymosin alpha-1 any approval.

            It has been discovered that the company that VitaLifeMD obtained the thymosin alpha-1 treatment from, Tailor Made Compounding, has been subject to FDA investigations and during these investigations, it was revealed that this company was operating under questionable standards. Dreisbach recalls, “the FDA told [Tailor Made Compounding] its inspectors had found ‘serious deficiencies in [their] practices for producing sterile drug products, which put patients at risk’" (Dreisbach). Moreover, directly related to thymosin alpha-1, Tailor Made Compounding had a “’sterility failure’ with a batch of thymosin alpha-1” in 2018 as well as failure to perform the necessary testing required to be able to accurately label the products they were selling (Dreisbach). 

                 

Timeline of COVID-19 events, featuring VitaLifeMD.

            There has been a rise in scam COVID-19 treatments, such as thymosin alpha-1, being offered to consumers as trials continue for a definitive treatment and vaccine. The Federal Trade Commission and Federal Drug Administration have been under intense pressure trying to make consumers aware of the potentially fraudulent activity they could be subject to. The FTC and FDA have made announcements about ways consumers can stay safe as “some people and companies are trying to profit from this pandemic by selling unproven and illegally marketed products that make false claims, such as being effective against the coronavirus” (FDA). They have been targeting companies making these claims and have been issuing notices for them to stop their claims immediately, as they are not allowed to falsely claim that a drug is FDA approved. The FTC is continuously monitoring social media as well as online marketplaces for these fraudulent products (Tressler). As of now, VitaLifeMD has not been contacted, which has sparked controversies as officials question how many companies are behaving in similar ways. As of October 2020, Congressman Raja Krishnamoorthi “is calling for the FDA and Federal Trade Commission to take action against one prominent doctor who has marketed the drug: Dr. Dominique Fradin-Read of Los Angeles” (Dreisbach). 

            Following the NPR investigation, Fradin-Read acknowledged that it was “inaccurate to describe thymosin alpha-1 as ‘FDA approved’” (Dreisbach). However, she declared, “I use thymosin alpha myself and have even given it to people who have serious issues, even my mom when she was fighting cancer”, citing research suggesting positive effects of using thymosin alpha-1 (Dreisbach). 

STAKEHOLDERS

During this unprecedented time, as individuals are desperate for solidified answers regarding COVID-19, treatments, and vaccines, there is heavy interaction between consumers and medical professionals for concrete answers. In this event, where consumers were being encouraged to use an unconfirmed treatment for COVID-19, many stakeholders are affected. To begin, Dominique Fradin-Read and VitaLifeMD are prominent stakeholders as they were promoting thymosin alpha-1 as one of the "best" treatments for COVID-19 to patients and making a profit. She was giving her medical recommendation to them on ways that they can protect themselves against the coronavirus, even though they were not approved by the FDA as treatments, and utilizing social media to stretch her influence to more individuals. Another influential stakeholder is Tailor Made Compounding. Tailor Made Compounding is one of the reasons that VitaLifeMD and multiple other practices were able to get thymosin alpha-1. It was their production efforts and continuous supply, resulting in business for them, that allowed these companies to provide thymosin alpha-1 to their consumers.

 The most obvious stakeholder is the consumers utilizing thymosin alpha-1. It has been noted in the NPR investigation that around 100 known patients were prescribed thymosin alpha-1 by one doctor, with VitaLifeMD's numbers unknown (Dreisbach). They were following medical recommendations to use this drug as a treatment for COVID-19, listening to claims that it was “FDA approved” and one of the “best” options available (Dreisbach). As a result, they may have changed their adherence to CDC guidelines and relied on the drug for guaranteed protection from the coronavirus. Another stakeholder is the general public and these individual’s families. By these consumers using thymosin alpha-1, their reliance on the drug as a cure and preventive measure may have made them less willing to follow CDC guidelines, including social distancing and wearing masks, putting the general public and their families at a greater risk for catching the virus. 

The FDA has been playing an active role in monitoring the safety of consumers during the pandemic.

            Lastly, another main stakeholder is the federal government agencies. The FTC and FDA are under great pressure to keep these items off the market and protect consumers from fraudulent business activities, all while monitoring the development of actual appropriate treatments and vaccines for the coronavirus. This situation takes away from their commitment to finding actual treatments and vaccines as they have to spend time placing more preventive measures for consumers to protect them from being a victim to a false claim by businesses or individuals.

INDIVIDUALISM

            Coming from an Individualistic perspective, encouraging the use of an unproven coronavirus treatment would be unethical. 

Milton Friedman believed that businesses need to maximize their profits to the best of their ability, but make sure that all business actions are done within the law (Salazar, 17-18). In this situation, the laws in place in the United States and the government agencies that exist, restrict what businesses are allowed to do. VitaLifeMD was advertising and promoting the use of thymosin alpha-1 to consumers. It was noted in the NPR investigation that thymosin alpha-1 costs around $400 for a one-month supply (Dreisbach). VitaLifeMD was reminding consumers on social media platforms about the benefits that using thymosin alpha-1 brings, such as a treatment for the coronavirus, resulting in more consumers purchasing the product, and therefore increasing profits. NPR reports at least 100 individuals were purchasing thymosin alpha-1 from wellness doctors to help protect them from COVID-19 (Dreisbach). If Milton Friedman believed that it was okay to break the law, then this would be seen as a great act to increase profits for VitaLifeMD.

            However, one of the main ways that VitaLifeMD encouraged use and therefore convinced people to buy the drug was related to the statements of thymosin alpha-1 being “FDA approved” (Dreisbach). While the FDA has granted thymosin alpha-1 “orphan drug designation”, they have never given approval for the drug to treat any condition (Dreisbach). A business cannot market products with false claims or misleading information to consumers. According to the FDA, “the FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 diagnostic, prevention, and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unauthorized products with false or misleading claims” (FDA). Regarding VitaLifeMD’s claims about thymosin alpha-1 being “FDA approved”, Congressman Krishnamoorthi declares, “such false claims appear to be illegal and ought to be subject to strict enforcement by FDA and FTC” (Dreisbach). By VitaLifeMD making these claims, the FTC and FDA are responsible to get involved, as it is illegal and puts consumers at risk. Furthermore, the company that VitaLifeMD was receiving drugs from had their own share of violations. As an example, Tailor Made Compounding was failing to complete the necessary testing required to be able to accurately label the products they were selling, suggesting that the products on the market may not even be the products they claim (Dreisbach).

UTILITARIANISM

            Utilitarianism is an ethical theory that analyzes the consequences of actions on the individuals involved. It is focused on the principle of utility, the idea that happiness should be impartially maximized for all individuals, while considering the long-term effects (Desjardins, 32). As stated by Joseph Desjardins in An Introduction to Business Ethics, “Utilitarianism is typically identified as the policy of ‘maximizing the overall good’ or, in a slightly different version, of producing ‘the greatest good for the greatest number’” (Desjardins, 29). This ultimately means that happiness is intrinsically valuable so individuals need to act in ways that promote that overall happiness in the long run. When evaluating this case, a Utilitarian would find the promotion of an unproven coronavirus treatment as unethical.

            When looking at the short-run, a Utilitarian might believe that VitaLifeMD was acting ethically. VitaLifeMD was providing consumers with thymosin alpha-1 as it was believed that it boosted immune systems and worked well to prevent and treat COVID-19 (Dreisbach). Fradin-Read even recalled, “I use thymosin alpha myself and have even given it to people who have serious issues, even my mom when she was fighting cancer” (Dreisbach). Furthermore, it was mentioned that the patients of VitaLifeMD who received the thymosin alpha-1 had not had any severe or adverse reactions from the treatments they had received so far (Dreisbach). As a result, these individuals were not being directly harmed by their use of thymosin alpha-1 since they did not suffer severe side effects. These individuals, VitaLifeMD included, are having their happiness maximized as they now feel safer from COVID-19. Also, the company is able to generate more profit, which a Utilitarian would consider to be increasing happiness further for VitaLifeMD.

            However, when evaluating the long-term effects of this unproven coronavirus treatment, a Utilitarian would find the treatment unethical. To begin, Dominique Fradin-Read is not specialized in infectious diseases and is considered to be a wellness doctor (Dreisbach). The drug they were encouraging, thymosin alpha-1, has not received FDA approval for any treatment which prevents it from being available through regular pharmaceutical companies. VitaLifeMD also obtained their supply of thymosin alpha-1 from Tailor Made Compounding, a compounding pharmacy with documented evidence of “sterility failure” of thymosin alpha-1 and a record of failing to perform “identity testing” to accurately label the drugs they are selling (Dreisbach). So, when VitaLifeMD prescribes thymosin alpha-1 to the patients, it might not even contain the correct raw materials the company claims, as these compounding pharmacies’ products “are not tested for quality or safety by the FDA” (Gavura). Furthermore, the drug has not been verified as safe or successful for treating the coronavirus and the only studies they provide as evidence in support of this drug are early studies from China (Dreisbach). Therefore, VitaLifeMD’s patients may have been injecting an unknown substance into their body, with side effects that are not completely documented, and may have side effects appear in the future. 

            In addition, as these individuals begin to listen to VitaLifeMD's claims about thymosin alpha-1 being beneficial for preventing and treating the coronavirus, they may begin to disregard other safety requirements in place for the coronavirus. As an example, these individuals may use thymosin alpha-1 instead of wearing masks or social distancing. Wearing masks and maintaining a 6-foot distance from others have been recommended by the CDC as a way to effectively prevent the spread of the coronavirus (CDC). By not adhering to guidelines in place, they are not only putting themselves at higher risk for catching the virus, they are putting others at a higher risk of being infected by them, accompanied with a false mindset that they are safe because of their thymosin alpha-1 use. As a result, the long-term effects would be potentially exposing more individuals to the coronavirus and therefore decreasing the happiness of a larger amount of people.

KANTIANISM

            Kantianism, a product of Immanuel Kant, places constraints on actions as well as motivations. Within Kantianism, the Formula of Humanity states, “act in such a way that you treat humanity, whether in your own person or in the person of another, always at the same time as an end and never simply as a means” (Salazar, 9). Ultimately, this declares that individuals should never be treated as a mere means as they all have rationality within them, which Kant believes is intrinsically valuable. As a result, in the case of promoting individuals to inject an untested coronavirus treatment, a Kantian would declare this act unethical. 

VitaLifeMD was making false claims about thymosin alpha-1. They posted on multiple social media platforms that thymosin alpha-1 had “FDA approval” and was one of the “best” ways to prevent and treat the coronavirus (Dreisbach). The FDA had never approved thymosin alpha-1 for any treatments. In fact, there is no vaccine to prevent COVID-19 and only Remdesivir is FDA approved for the treatment of COVID-19 (Harvard Health Publishing). VitaLifeMD’s claims can be considered to be untrue and deceitful. They were convincing consumers to believe that thymosin alpha-1 was the miracle drug they needed to be safe from the coronavirus with information that was not verified and, in some cases, completely untrue.  Consumers were desperate for a cure for this virus and they believed a medical professional was telling them the truth, however this was not the case. A false FDA claim is an example of VitaLifeMD lying to the consumer. As a result of this lying and false advertising, the consumers were unable to make informed and rational decisions, taking away their rationality, which is unethical according to a Kantian (Salazar, 17). When assessing the motivation behind this case, it is impermissible and immoral to provide this treatment to individuals knowing they are unable to give their rational consent and being unaware of potential long-term side effects of prescribing this treatment.

            According to Kant, in addition to rationality, one must be logical (Salazar, 6). Regarding Kant’s Formula of Universal Law, it would have been helpful in the case of VitaLifeMD to consider this: “Everyone will make false claims that their coronavirus treatment is FDA approved in order to expand their company’s reputation and make more money.” When evaluating this statement, it is important to consider that if everyone is making false claims about the FDA and approved coronavirus treatments, the FDA will know you are making these claims and prevent you from doing so. They will know which treatments are approved and which treatments are falsely claiming approval, and prevent the business from making those claims. This would result in everyone not being able to make these claims and therefore not making an additional profit from the claims. There is a contradiction in everyone completing this maxim so it is impermissible to act on.

VIRTUE THEORY

            Virtue theory is a unique ethical theory in the sense that it examines different character traits in order to determine if someone is acting ethically. Heather Salazar emphasizes this when she says, “Act so as to embody a variety of virtuous or good character traits and so as to avoid vicious or bad character traits” (Salazar, 22). Traits that aid in growth and fulfilment are virtues, while traits that are inhibiting to one’s growth and fulfilment are vices (Salazar, 23). Five virtues of business include courage, honesty, temperance, justice, and prudence (Salazar, slides 4-6). VitaLifeMD lacked the main virtues of business when prescribing thymosin alpha-1.

            For courage, a virtue theorist looks for companies/individuals taking risks and being able to stand for what is right (Salazar, slide 6). VitaLifeMD did not act courageously by providing thymosin alpha-1 to patients. VitaLifeMD did take a risk by offering thymosin alpha-1 to patients under false claims that it was FDA approved and was a good way for them to prevent COVID-19. However, when Fradin-Read was questioned by NPR, she acknowledged that it was wrong to claim thymosin alpha-1 was “FDA approved”, yet she still believes that it is appropriate to use the drug, citing research from China (Dreisbach). What takes away VitaLifeMD’s courage is that VitaLifeMD did not stand for what is right. They defended their use of the drug for the coronavirus which ultimately is “unlawful because such claims are not supported by competent and reliable scientific evidence” (Dreisbach).

            A Virtue Theorist would argue that VitaLifeMD violated the virtue of honesty by providing consumers with false claims to mislead them into purchasing the product. It is widely known that there is one FDA approved treatment available for COVID-19 and that there is no current vaccine. VitaLifeMD claimed that thymosin alpha-1 was “FDA approved” and the “best” treatment for the coronavirus, attempting to manipulate consumers into believing that they have some sort of miracle treatment available to them (Dreisbach). By providing this false information and making false claims on social media platforms, VitaLifeMD did not act honestly.

            When it comes to the virtue of temperance, the business should have “reasonable expectations and desires” which VitaLifeMD lacked (Salazar, slide 6). VitaLifeMD was making false claims involving a government agency and marketing unproven products to consumers, all while knowing that there are no vaccines for COVID-19, that people are desperate for a cure, and that only one treatment is FDA approved as of now. They did not consider the potential consequences of claiming that a product was FDA approved when in reality, it was not. Additionally, they had to utilize compounding pharmacies rather than regular pharmacies, with limited safety measures in place, in order to get this product, since it lacks the requirements to be sold commercially. Ultimately, these expectations were unrealistic and hazardous as they put the lives of consumers at risk for profit.

             Justice requires a company to have quality products and fair practices (Salazar, slide 6). VitaLifeMD does not satisfy the virtue of justice as they utilized products that were potentially hazardous to consumers. Tailor Made Compounding, VitaLifeMD’s thymosin alpha-1 supplier, has had known instances in which their thymosin alpha-1 products were unsterile and potentially mislabeled (Dreisbach). This is public knowledge, yet they continued to prescribe thymosin alpha-1 to patients while making false claims about their effectiveness in order to get a profit.

            Lastly, when it comes to prudence, a business needs to make the right decisions to consider the future potential consequences of completing the action (Salazar, slide 4). Therefore, the encouragement of the injection of thymosin alpha-1 was completed with a lack of prudence on VitaLifeMD’s part, as they did not consider the potential risks of making false claims about products on the success of her business in the long run.

JUSTIFIED ETHICS EVALUATION

            In my opinion, VitaLifeMD’s actions were unethical. If VitaLifeMD had approached consumers during the pandemic in a different way and with different tactics, this entire situation could have been prevented. As mentioned earlier, Dominque Fradin-Read is not a specialist in infectious diseases and works within the wellness industry. I believe she is well-qualified to provide advice on ways to boost one’s immune system and keep themselves healthy. However, she may not be qualified to tell individuals that a drug is FDA approved when it isn’t, and effective to prevent/treat the coronavirus when there is no proven evidence. Companies across the United States specializing in infectious diseases have been working tirelessly to find treatments that are actually effective and are working toward FDA approval, so VitaLifeMD making these claims takes away from the work they are doing and distracts consumers from the end goal.

VitaLifeMD promoting Thymosin Alpha-1 on social media.

            There is nothing wrong with promoting the use of drugs to boost one’s immune system, as long as they truly do what they are said to do and are safe for consumers to use. In the case of VitaLifeMD, it is  unethical of them to purchase and sell thymosin alpha-1 from Tailor Made Compounding due to the lack of safety precautions within that company, putting consumers at higher risks. Additionally, since thymosin alpha-1 is not FDA approved, it is wrong of VitaLifeMD to make claims online suggesting health benefits to consumers without scientific evidence to support it. It would’ve been different if VitaLifeMD told the world they had great ways for people to boost their immune systems and strengthen their ability to fight COVID-19 as a supplement to social distancing and mask usage. They potentially jeopardized the lives of hundreds by giving them a false sense of security during a pandemic and providing them justification to let their guard down.

COMPANY ACTION PLAN

            VitaLifeMD is just one of a few major companies being attacked for encouraging the use of unproven coronavirus treatments to patients. VitaLifeMD was promoting the use of thymosin alpha-1 and falsely claiming it to be an FDA approved treatment, claiming benefits that are not scientifically backed to be in support of treating the coronavirus (Dreisbach). Fradin-Read was contacted by NPR as part of their investigation and admitted that it was “inaccurate to describe thymosin alpha-1 as ‘FDA approved’”(Dreisbach). The product is not currently listed anywhere on VitaLifeMD’s website. Additionally, VitaLifeMD removed all social media posts related to thymosin alpha-1. VitaLifeMD is not against the use of the drug, citing studies where thymosin alpha-1 has been used as a treatment (Dreisbach). The FDA and FTC have begun taking action against companies making these false claims and selling these products to consumers. As of October, Congressman Raja Krishnamoorthi is calling for direct action of the FDA and FTC against VitaLifeMD (Dreisbach).

            Currently reflected on VitaLifeMD’s website is the statement: “We believe every patient can achieve happy and healthy longevity through the continuation of a proper health education and an integrative, personalized medical approach” (VitaLifeMD). To guide VitaLifeMD on their path to successful profits in the future and ultimately achieve high rates of customer satisfaction and safety, a mission statement I recommend is: “We believe every patient can achieve happy and healthy longevity through the continuation of transparent and honest health education and an integrative and trustworthy medical approach” (VitaLifeMD). As the main issue that VitaLifeMD struggled with was related to the basis of trust and transparency, I feel that their mission statement needs to include those phrases to reassure consumers that the health instructions they are given when they talk to individuals at VitaLifeMD are credible and completely debriefed. Consumers need to be able to make their own education decisions and rely on their doctors to provide them with the correct information to do so. Therefore, it is not enough to provide patients a “proper health education”, one needs to provide patients with a “transparent and honest health education” fueled by trustworthy advocates (VitaLifeMD). When one goes to the doctors, they need to be able to rely on the information they are given so trust and transparency will be fundamental aspects of Fradin-Read’s practice. This mission statement will act as a regular reminder of ethical behavior and reiterates the idea to VitaLifeMD that without consumers, the company wouldn’t exist, so it is essential to ensure that unethical behavior is prevented.

            A few core values that are relevant to the company include customer safety, accountability, trust, and innovation. Customer safety will be the core value of VitaLifeMD as customers come to them, lacking medical knowledge, for their professional advice and guidance. VitaLifeMD is responsible to provide patients with products with documented evidence that they are safe. When it comes to choosing the suppliers of products, VitaLifeMD needs to go out of their way to ensure they choose reputable suppliers to ensure that their patients are provided the best possible products. For accountability, VitaLifeMD needs to own up to any mistakes that are made. All companies will make mistakes throughout the course of their time. It is essential that when mistakes are made, such as false claims of drugs being FDA approved, VitaLifeMD acknowledges any and all wrongdoing and provides measures for customers to receive reparations. Trust is essential in business to develop relationships with the customers. Especially in the medical field, it is vital that patients are provided accurate and transparent information so they are able to make educated decisions, particularly information regarding any potential side effects or studies conducted on the product involved. Lastly, in the wellness industry there are always newfound discoveries that can enhance one’s health. VitaLifeMD will pride itself in innovation and finding new ways to support patients, while making sure that all innovative ideas are safe for consumer use and free of false information. By following these values, it will be hard to divert from ethical behaviors as they are embedded in trust and doing what is right, ultimately setting up VitaLifeMD to conduct business in an ethical fashion.

            To ensure productivity in the future and prevent situations such as this one from occurring again, there needs to be adjustments to the systems at VitaLifeMD, including additional staff members and new policies. In order to provide a system of checks and balances in the workplace, I feel that it is necessary for Fradin-Read to have another influential figure around. I recommend that she hires an individual who acts as a supervisor to not only herself, but the other individuals with the company. This individual would be a second set of eyes to Fradin-Read when making decisions and would ensure that the company follows their core values through setting goals, monitoring customer feedback, and continuously checking safety standards. This also takes some work off of Fradin-Read’s plate as she would have another individual ensuring that the processes and procedures in place are appropriate and being followed by the company. At times, it is necessary for even the owners of a company to have someone providing them authoritative guidance and I believe it would fuel ethical behavior. Fradin-Read, her supervisor, and all employees will be required to meet on a weekly basis to cover business initiatives and will be required to complete ethics-based training once a month. If everyone is familiar with the business model and they are forced to discuss it every week, the likelihood of someone acting unethically would decrease.

            It would also be increasingly beneficial to hire a well-qualified individual responsible for supply management. If someone was in charge of evaluating the products that need to be ordered and choosing which companies to order products from, it would be highly unlikely that a situation such as this one would occur again. Their sole job would be choosing reputable companies with no known safety violations as well as researching products to ensure that all information known can and will be provided to consumers. They will make sure that companies such as Tailor Made Compounding are not providing the products to the company.

Another essential hire will require an investment in social media experts. These individuals will be the ones responsible for all information being posted online and will be vital in the rebranding of the company. From here on out, they would be responsible to verify that all information posted online is credible, reliable, and backed with data. A new policy in place that they would need to follow would be that any information posted about a product on social media. needs to have a hyperlink leading consumers back to their website so they can access all vital information regarding side effects, clinical trials, effectiveness, etc. This may seem unnecessary and tedious, but it would prevent the company from engaging in unethical behavior as consumers will be able to evaluate the information given and conduct their own research as well.

In order to give VitaLifeMD a refreshed view in the eyes of consumers, remarketing is necessary. To remarket the company, VitaLifeMD will continue to utilize social media platforms to engage with consumers and reduce any potential fears they have regarding the company. Ads will promote the new hires and their roles, new policies, and focus on customer safety initiatives. It is essential that they portray a company founded on trust and transparency within these posts and this begins with addressing the issue at hand. If the company doesn't publicly acknowledge that they were promoting thymosin alpha-1 as FDA approved and a great option for fighting the coronavirus, they may never be able to regain that trust again. Once the issue is addressed, and a formal apology is posted, all future social media posts will be backed with verified information that consumers can read. Social media is a great way to connect with potential consumers so a revised social media approach will contribute to more awareness from consumers and drive consumers to the website, increasing profits.

While my plan will take considerable time, money, and energy to be implemented, it will allow for VitaLifeMD to continue business and grow in the future. VitaLifeMD has great potential and can eventually expand their reach across the United States with their new social media approach. This plan will promote business products and productivity for VitaLifeMD as consumers will have more faith in the company and be provided with all required information to make informed decisions and then purchase products. As the consumers develop trust, their likeliness to purchase products and recommend them to others increases, furthering profits even more. When looking to the mission statement, the new policies in place will contribute to a company even more focused on consumers than before. All guidance provided to patients will be transparent and honest, ensuring that deceptive practices are gone and that patients will be improving their wellbeing, making VitaLifeMD the go-to company for many consumers’ wellness needs. They will be putting the customer’s health first and ensuring that they are accountable, trusted, and always looking for safe and innovative ways for advances in the health industry to continually provide consumers with the health benefits they desire. With additional checks and balances, employees with specialized positions, and recurrent ethical trainings fueling ethical behavior, VitaLifeMD will once again be providing consumers with the safe products they desire.

Danielle O

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