Showing posts with label vaccine. Show all posts
Showing posts with label vaccine. Show all posts

Sunday, December 12, 2021

Dr. Joseph Mercola Shares Disinformation on COVID-19 Vaccines (2020-2021)

 

Doctor Joseph Mercola 


Ethics Case Controversy


        Mercola has been under a lot of heat within the past year as he continues to fearmonger the people during times of uncertainty. Along with the COVID-19 vaccines, Doctor Mercola has publicly shared his opinions on being against all vaccines. Mercola has been the top funder of the National Vaccine Information Center “which has been the forefront of a movement that has led some parents to forgo or delay immunizing their children against vaccine-preventable diseases” (Satija). Doctor Mercola says he donated 2.9 million dollars to the center as he believes in their anti-vaccination mission. It also helps that their mission aligns with his company’s agenda to focus on alternative remedies such as supplements and vitamins rather than scientifically proven medicine. Doctor Mercola has stopped seeing patients to focus on his business selling these alternative forms of treatment to illnesses. Doctor Mercola is profiting off of the anti-vaccination groups.

    With all of the disinformation spreading due to Doctor Mercola, Mercola was named by the Center of Countering Digital Hate as the top spot in the “disinformation dozen”.  The disinformation dozen is a group made up of twelve people that range from physicians, anti-vaccinators, and those who promote alternative medication who have been spreading false information about COVID-19 online. A Facebook analysis showed that this disinformation dozen was the cause of 73% of almost 700,000 anti-COVID-19 vaccination posts. Out of this group, Mercola has been the most far-reaching spreader of disinformation. With it being known that some medically licensed professionals are speaking out against COVID-19, the “Federation of State Medical Boards issued a statement making it clear that doctors who generate and spread COVID-19 misinformation could be subject to disciplinary action, including having their licenses suspended or revoked… such unethical or unprofessional conduct may prompt their respective Board to take action that could put their certification at risk” (Knight). Though it is known that Doctor Mercola is spreading this false information about COVID-19, no action has been taken against him at this time.

    When in need of medical advice, the public is advised to seek out doctors for their medical professional guidance. However, during the COVID-19 pandemic, it was questioned whether all doctors were giving sound medical advice. Doctor Mercola, an osteopathic physician, has been sharing disinformation on the COVID-19 vaccines which would stray some away from taking a vaccination approach to the virus. Doctor Mercola “declared that coronavirus vaccines were ‘a medical fraud’ and said the injections did not prevent infections, provide immunity or stop transmission of the disease” (Frenkel).            Doctor Mercola has been known for spreading false information mainly through different social media platforms such as Facebook, Instagram, Twitter, and YouTube, and has published over 600 articles on these different platforms. These articles rather than bluntly stating Mercola’s opinions, ask questions about the safety of vaccines and use easily refuted studies as evidence. These different social media companies have responded by flagging the false claimed posts as well as taking some down that goes against the community guidelines of COVID-19. Other than that, there have been no real consequences for Doctor Mercola’s actions. Doctor Mercola makes sure his articles that he publishes about COVID-19 are available to all by translating them to multiple different languages which maximize his potential audience. Rather than focusing on the accepted studies about COVID-19 which are in favor of the vaccine, Mercola is focused on turning people away from vaccines and pushing unapproved and unproven products. For instance, on April 9, 2021, Doctor Mercola shared in a YouTube video that “inhaling hydrogen peroxide through a nebulizer could prevent or cure COVID-19” (Knight).

    Along with the use of hydrogen peroxide, Doctor Mercola promotes different natural supplements, vitamins, and diets, which are sold by his company, to cure and prevent COVID-19. On Mercola’s website, Mercola sells Liposomal Vitamin C, Liposomal Vitamin D3, and Quercetin and Pterostilbene which he claims will mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The Food and Drug Administration sent a warning letter to Mercola about the misbranding of his products in relation to COVID-19 and how these unapproved products were in violation of the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration advised Mercola to take immediate action to address the violations that were stated in the letter and to review his website, products, and other promotional materials to not misbrand anything about COVID-19.




Stakeholders


The stakeholders in this specific case would be Doctor Joseph Mercola, other doctors and researchers in the medical field, anti-vaccinators, social media platforms, shareholders of these platforms, and the general public. Everything that happened in this specific case stemmed from the actions of Doctor Joseph Mercola. All of his actions affect his reputation; therefore, he is affected in this case. Along with Doctor Mercola, other doctors and researchers are affected by this case as well. Though Doctor Mercola is affecting his own reputation with his actions, he also is a representative of the professional medical field, and his actions will reflect on other doctors and medical professionals. Those who are a part of anti-vaccination groups are affected by Mercola’s actions in this case as they are normally unrepresented in the medical field and with the “disinformation dozen” and more specifically Doctor Mercola, there is more representation of this group. Social media platforms are affected as this is where Doctor Mercola is spreading a majority of his information. The shareholders of these platforms are affected as the way the social media platforms handle the situation can alter the future value of the company’s stock. The general public is affected because the vaccines are readily available for everyone and therefore the people are having to decide whether to listen to Doctor Mercola and not get the vaccine or to not listen to him. Further analysis of the stakeholders is later discussed in the utilitarianism portion.


Individualism


An individualist would view the case of Dr. Mercola spreading misinformation and unproven medical treatments for Covid-19 is ethically permissible, but not morally okay. Under individualism, the only goal of a business is to profit, so the only obligation that the businessperson has is to maximize profit for their owner and stockholders within the law of the land (Salazar 17). Dr. Mercola has sold books and natural medication to maximize profit and he does it within the law, when related to the Covid-19 case. The only unlawful action he committed in the past was selling tanning beds named Vitality and D-lite for $1,200 to $4,000 to reduce cancer. But since Dr. Mercola’s health claims about the tanning beds were false advertising, he had to pay $2.95 million in refunds to customers. Currently regarding to the Covid-19 case, Dr. Mercola has not sold any product that is against the law. Dr. Mercola’s net worth derived largely from his books and treatments and has grown to in excess of $100 million (Frenkel).

Doctor Mercola's book about COVID-19 

Dr. Mercola has maximized profits from selling his book, The Truth about Covid-19 and selling supplements that he said would cure Covid-19. The profits from sales do not only satisfy Dr. Mercola’s business expectation, but also his stockholders as he gives back some of that money as a thank you for investing into his company. In Dr. Mercola’s defense many businesspeople such as magazine publishers spread “fake news” to get the public’s attention to buy their product, which maximizes profit. It is clear that Dr. Mercola and other anti-vaccinates actions were ethical under the individualist’s view since he maximizes profit while doing it under the law. But although it is ethical, it is not morally right. The misinformation being spread about the Covid-19 vaccine is creating confusion and anxiety for people who are thinking about being vaccinated. At the end of the day the disinformation is “playing with people’s lives” as it did to someone important to me.


Utilitarianism


A utilitarian would view Doctor Mercola spreading disinformation about COVID-19 vaccines as unethical. Under utilitarianism, businesses should aim to maximize long-term happiness in their actions for all conscious beings that are affected by the action (Salazar 19). According to Salazar, “long-range perspective can help businesses avoid short-sighted thinking that often boosts profits momentarily but leads to a quick demise” (Salazar 20). In The Case Manual, Salazar also states that utilitarianism “is used to analyze the costs and benefits of a particular course of action” (Salazar 19). In this specific case regarding Doctor Mercola sharing disinformation on COVID-19 vaccines, happiness was not maximized for the majority of the stakeholders which is as follows:

Doctor Joseph Mercola: Doctor Joseph Mercola will ultimately be positively impacted in this situation. With the case being strictly revolved around him profiting off of spreading misinformation and misbranding his products, Doctor Mercola will be happy. Although Doctor Mercola is happy during the time of the pandemic that his message is being spread and listened to, this is only a short-term effect of happiness.

Other Doctors and Researchers in the Medical Field: The case based on Doctor Mercola negatively impacts other doctors and researchers in the medical field. With Mercola spreading around false information against the COVID-19 vaccine, it looks like the medical community is not a united front during this time of confusion and discredits the community. Mercola’s actions do not maximize happiness for the other doctors and researchers as they now have to do “damage control” to inform patients who are misinformed that Mercola has been using studies that have been easily refuted and disregarded as evidence. The majority of the medical community aggress with the science behind vaccines and Mercola’s actions are not maximizing their happiness.

Social Media Platforms: Social media platforms are negatively impacted by these false informed posts and videos made by Doctor Joseph Mercola. These posts go against COVID-19 community guidelines of these platforms which is negative towards the companies. In order to fix these issues, the social media platforms have begun flagging and taking down COVID-19 posts that have incorrect or false information. With this going on, Doctor Mercola began taking down some of his own posts, but that did not stop some of his other posts from coming down, but him originally posting these types of posts does not maximize the happiness of these platforms.

Shareholders of the Social Media Sites: The shareholders of the social media platforms used by Doctor Mercola to share his false information are benefited. The shareholders are benefited in this specific case because the platforms have taken a stance against COVID-19 false informed posts and will either flag them or take the posts down. With the social media platforms taking this stance, it benefits the shareholders as this will likely increase the stock price and make the shareholder more profit.

General Public: Overall, the public is negatively impacted by Doctor Mercola’s actions. Although the anti-vaccinators are benefited as they have representation in the medical community and can use Mercola’s articles as their own evidence, the general public will be negatively impacted. It is no surprise that the COVID-19 pandemic has been a wide-range state of confusion as there has not been a pandemic like this in our lifetimes. Information came out as it was found as there was no previous information regarding this virus affecting humans. COVID-19 transmission has been a large risk as there have been many deaths due to the virus as patients are immunocompromised, unvaccinated, or for other reasons. By Mercola misbranding his own products and trying to turn the public away from getting the vaccine, he is putting his own happiness before everyone else’s which is against utilitarian views.

Overall, stakeholders are not benefiting from the specific case at hand. With this case not benefiting the majority and not maximizing the long-term happiness of the majority of stakeholders, the actions of Doctor Joseph Mercola are unethical and morally wrong.


Kantianism


It is unequivocally clear that Dr. Mercola and many of the other Disinformation Dozen are using the American People as a mere means to achieve an end. Most of these spreaders of false information all have one similar goal, and that is to do whatever is necessary to increase their popularity and prestige as well as their financial interests. And how is it they are doing this? By using humans as a mere means. These actions, a Kantian would argue, are morally impermissible. It is the view of a Kantian that one must act consistently with one’s own rules while never considering oneself exempt, where it is imperative that one must follow the Formula of Humanity: never treat another human as a mere means but rather as an end. Whether one is acting in a morally permissible manner, is determined through the categorical imperative. The Categorical Imperative is what enables an individual to determine whether he is acting rationally, where if one is acting rationally, they are subsequently acting in a morally permissible manner. According to these rules, Dr. Mercola’s actions are morally impermissible. It can be determined that Mercola did in fact treat his readers as a mere means by one criterion alone, he lied to them. The act of lying to an individual is to treat them with contempt while assuming that they are not worthy of the truth. As a doctor, Mercola must have known that his conclusions were false, regardless he still published these articles in hopes that it would spark a reaction to bring him popularity. In his book he states that the “vaccine alters your genetic coding” (Frenkel), this is him lying, this is him using people as a mere means. Now that we can see he blatantly used humans a mere means we must look for the end to which he used these people. By publishing these fallacies, he provoked a paranoid audience, encouraging people to rapidly purchase the book, placing him on the New York Times best-selling list (Frenkel). The prestige and honor of publishing a book that makes it to this list was his goal, the ends in this scenario. By lying to people, he became an even more well-known doctor; this is the epitome of what Kant would deem morally impermissible.


Virtue Theory 


The virtue theory is based on Aristotle functionalism and it says that we should base goodness upon what a thing's purpose and characteristics are. Everything has a purpose, and we have to figure out what that thing's purpose is to determine if that thing is good at meeting its purpose. We should be functioning well and living out our purpose in order to live a good happy life. To achieve this, we need to be exercising our rationality, meaning we also need to get along in society. Not only should we be rational in ourselves but rational when it comes to living together as human beings in a society. What enables us to survive and thrive and allows us to properly function are our virtues and our character traits. Some of these virtues applied though the case of Dr. Mercola are:

Courage: According to vaccine activists what Dr. Mercola displayed was instead a vice, an act of cowardness. To be courageous is to stand up for what is right, but in their eyes, he is on the wrong side of the controversy. They would argue that he is uncredible and is too afraid to face the truth that the vaccine is safe because it would go against all his past claims about how vaccines are a fraud. On the other hand, anti-vaxxers would argue the opposite. They would champion him on his courage to say what many ought not to dare say in this kind of political climate. He put his opinion out there for others to read even though it may cost him his platform, therefore he is standing up for his beliefs and what they believe to be right.

Honesty: Dr. Mercola never sources the information he states in his articles, and rather he comes up with these baseless claims himself or repeats the many different conspiracies on the internet regarding the Covid and the effectiveness of masks. There has been an abundance of factual researched evidence that both the vaccine and masks are effective and safe, which the majority of trustworthy doctors agree with. Therefore, in no way is Mercola displaying the virtue of honesty.

Temperance/Self-Control: There is no balance in Dr. Mercola’s messages. He will call the vaccine anything but safe and will continuously push the many conspiracies that he happens to come across. He wants people to buy his alternatives to the vaccine, meaning it is likely he will never admit that vaccines are effective. Where there is more talk about Mercola’s supplements there is more opportunity to make money, so Mercola has ended up publishing over 600 articles that then get reshared thousands of times. Due to his excessive amounts of posts that only convey his opinion, he lacks temperance or self-control.

Justice/Fairness: None of Dr. Mercola’s supplements are approved by the FDA and he has gotten in trouble many times in the past with the administration for selling them. Without FDA approval his supplements can be considered a non-quality product which isn’t fair to consumers. Along with not selling good quality products, he doesn’t consider any perspective other than his own, often making false claims against reputable sources. Even in the context of masks which are very much proven to stop the spread of Covid, he continues to claim that they do not work. Without providing his consumers with a clear approval that justifies him selling his own goods and not respecting other viewpoints on the matter, Mercola does not have the virtue of justice or fairness. 

Action Plan

Dr. Mercola has shared many disinformation articles on Facebook  

Dr. Mercola's actions are a danger to society’s well-being that immediately need to be addressed. His anti Covid vaccine rhetoric that he spreads across his website and various platforms has scared many people away from getting the life-saving vaccine. Instead he continues to push the narrative that the supplements he sells on his website are proven to do a better job at curing and treating Covid than the vaccine. While many people are growing frustrated with social media sites' crackdown on Covid disinformation, there are some steps Mercola could take to stay within the guidelines of social media sites and the food and drug administration. If Mercola wishes to notify others of information regarding the vaccine then he should only base his scientific conclusions on reliable research. Many of the posts that get taken down by social media sites are the posts that contain unreliable research that Mercola made up himself. This change will allow him to still voice his opinion and make profits without getting his posts taken down. From society’s perspective, citing reliable information may disclose that Mercola now has a weaker argument against the vaccine, meaning people who were once scared of the vaccine may be more open to receiving it. Any product that isn’t FDA approved to treat or cure Covid-19 should not be marketed as if they are able to on Mercola’s website. This ensures that Mercola is staying within FDA guidelines and isn’t harming people with falsely advertising his products. To ensure that society can find more reliable information regarding the Covid-19 vaccine, all social media platforms need to do their part in eliminating misinformation about Covid-19. Dr. Mercola should also limit his information to only his website and books. This will allow CDC and other reliable sources' proven facts about Covid-19 to have more of an impact on social media sites, which will lead to more reassurance to those considering the vaccine. These changes to Dr. Mercola’s actions will not only help his company operate ethically but also save more lives. Need two other ideas. Perhaps stop posting on social media sites altogether and just on his website where he will have less of a reach? Only put this information in books so it isn't spreading like rapid first.

Doctor Mercola’s website should have a mission statement to provide supplements for health related issues that are accurately promoted in a safe and efficient way. This mission statement will help guide Dr. Mercola’s business into creating more accurate and reassuring information about the Covid-19 vaccine that will save lives. The mission statement aims to have society’s health best interest where Dr. Mercola’s mission was to provide and sell unproven treatments that would misled the public to generate profit. 

Mercola should hold honesty, reliability, fairness, and profitability as values in his business as well as in his actions. Mercola should be honest about the way he brands his products as they will still be profitable whether he is misbranding them or not. He should also be reliable as a doctor to give truthful and relevant information about the pandemic. Though he has strong opinions on the COVID-19 vaccine, due to his medical title he should be sharing information that is widely backed up by science rather than information that only benefits his personal company. He should be a reliable source of information. Mercola should value fairness as he goes about his business. He should be fair to the many stakeholders in this case by providing accurately branded products, and be a reliable source of information. He should be a fair businessman. Along with valuing honesty, reliability, and fairness, Mercola should value his profits. Although it can be argued that is what he is doing at the moment, he should focus on the profits of products that are properly advertised and branded that do not give off a false interpretation of outcomes. By focusing on the profits of his accurately branded products, Mercola can effectively evaluate the response of his products and implement products that will satisfy the market's needs. 

It is imperative to ensure that ethical productivity is maintained and an individual's ethics are frequently monitored. In order to certify that these matters never occur again, individuals on elevated social platforms must always be under ethical scrutiny. The individualist argues that, so long as an individual is acting in a manner consistent with the law towards the maximization of his profits, then his actions are ultimately legal. This concept is what allowed Dr. Mercola’s false claims to temporarily prevail, as through this viewpoint he was acting rationally. In order to combat this, one must look to policy; a red flag arises, when viewing this case under the knowledge that his actions were legal. If a more proactive legislative action was taken, this could have been prevented. The only way an individual would ultimately deem his actions wrong, is if the act is illegal. If laws are written concurrently with some of these ethical theories, then actions such as Mercola’s spread of misinformation may have been stopped. 

Another productive means of monitoring Dr. Mercola’s ethics to have prevented the situation, is through Kantianism. As stated prior, a Kantian would deem Mercola’s actions as morally impermissible right at the start, as he was acting inconsistently with the Law of Humanity. If individuals acted immediately after acknowledging the doctors unethical actions, the situation could have been eased. As these ethical foundations are so effective in preventing adversity, employers should incorporate these concepts into the training and schools should insert the content into the curriculum. For when the majority of individuals in a society are aware of ethical productivity and the monitoring of ethics, individuals will be able to deem actions on their moral permissibility, and subsequently act to prevent further harm. 

The plan outlined above established a way for Dr. Mercola to promote his business profits and productivity, while keeping the public safe. Having an overview of issues that have occurred during Mercola’s business, allowed us to create steps that will help his business run ethically. Establishing a mission statement for Mercola’s business will guide his business to maximize products and productivity. Not only does the mission statement promote business profits and productivity but it portrays the true intentions of a business. The mission statement will guide Mercola and his business to find strategies to fulfill consumer needs and have the consumer’s best interest in mind. For Mercola to run his business ethically with no issues, his business should promote values such as honesty, reliability, fairness, and profitability. These values will guide Mercola’s business to function more ethically, which will eliminate any issues from occurring in the future.
 

Authored By: Carlie Smith, Naomi Golasinski, Alexandria Morris, and Sean Alvord

 

References

Casado, Laura. “This Natural Health Doctor Has Published over 600 Articles Claiming Coronavirus Vaccines Are a Fraud - He's Part of the 'Disinformation Dozen' Responsible for the Vast Majority of Covid-19 Misinformation on Facebook.” Business Insider. Business Insider, July 25, 2021. https://www.businessinsider.com/mercola-doctor-disinformation-dozen-anti-covid-vaccination-2021-7.

Center for Food Safety and Applied Nutrition. “Mercola.com, LLC - 607133 - 02/18/2021.” U.S. Food and Drug Administration. FDA, February 18, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercolacom-llc-607133-02182021.

“Facebook - Latest News, Pictures & Video - Mirror Online.” mirror. Accessed December 12, 2021. https://www.mirror.co.uk/all-about/facebook. 

Frenkel, Sheera. “The Most Influential Spreader of Coronavirus Misinformation Online.” The New York Times. The New York Times, July 24, 2021. https://www.nytimes.com/2021/07/24/technology/joseph-mercola-coronavirus-misinformation-online.html?fbclid=IwAR1i7ukiXsWB9Ks1M0VTaXks6Jmftk5wx6RK7moCtfDBWAZWL51_GMKhnEU.

Knight, Victoria. “Doctors Spreading COVID-19 Misinformation Have Not Been Penalized.” Time. Time, September 20, 2021. https://time.com/6099700/covid-doctors-misinformation/.

“One of the Most Influential Voices in Vaccine Misinformation Is a Doctor.” NPR. NPR, August 8, 2021. https://www.npr.org/2021/08/08/1025845675/one-of-the-most-influential-voices-in-vaccine-misinformation-is-a-doctor.

Salazar, H. The Business Ethics Case Manual. n.d.

Satija, Neena, and Lena H. Sun. “A Major Funder of the Anti-Vaccine Movement Has Made Millions Selling Natural Health Products.” The Washington Post. WP Company, December 23, 2019. https://www.washingtonpost.com/investigations/2019/10/15/fdc01078-c29c-11e9-b5e4-54aa56d5b7ce_story.html.







Monday, November 30, 2020

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.