Wells Pharmacy Network is a compounding pharmacy that specializes in wellness, anti-aging, weight management, urology, sexual health, thyroid and adrenal health, and veterinary compounding solutions. They claim that “patient safety is [their] priority and [their] commitment to the quality of the preparations [they] compound is the most important thing [they] do each and every day” [11]. Looking into the history of the Wells Pharmacy Network, one would see that this a very far-fetched claim. They have had several scandals in the past decade including unsanitary conditions, misbranded drugs, recalled products, and several FTC violations. The most recent wrongdoing of the compounding pharmacy is Quad Immune. Quad Immune is “a combination of 4 products clinically demonstrated effects on the immune system” [6]. Wells Pharmacy Network has advertised Quad Immune as a treatment for COVID19. This sounds all well and good until you find out that their big ticket item, Thymosin alpha 1 “has not been approved by FDA, nor has it been proven safe or effective for treating COVID-19” [5].
This case will be looked at through the four different ethical lenses, Individualism, Utilitarianism, Kantianism, and Virtue Theory. According to Individualism, the actions were unethical as they broke the FTC. Then a utilitarian would argue that more harm was done in the case than maximizing happiness. A Kantian will argue that the company’s actions were impermissible because they were not loyal or honest to their patients. And according to Virtue Theory, this case is unethical because Wells Pharmacy Network did not satisfy any of the four characteristics: courage, honesty, temperance, and justice. Based on these ethical theories, I would suggest that the company needs to fix all of the problems they have had over the past several years to repair their image and their relationship with their patients.
Company Background:
In the summer of 2012, Franck's Compounding Lab of Franck's Pharmacy in Ocala, Florida was closed in the wake of The Centers for Disease Control and Prevention (CDC) warning “urging physicians not to use sterile products made by Franck's Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy” [4]. The drug that was giving patients fungal infections in their eyes was called Brilliant Blue G, or BBG, which was never approved by the FDA. “Investigations by numerous state, county and federal health agencies concluded that Franck’s BBG was adulterated and not sterile and that the defendants had violated numerous federal rules and regulations” [7]. “The FDA investigators observed numerous instances of unsanitary and inappropriate practices by compounding technicians who left and re-entered clean rooms without changing lab coats, who were touching non-sterile items while wearing their sterile gloves and then returned to compounding activities” [7]. This was the last of many scandals from Franck’s Pharmacy.
The connection from Wells Pharmacy Network to Franck’s Pharmacy is that “Franck’s Compounding Lab, which was one of the largest compounding labs in the country, was bought by Wells Pharmacy Network” [4]. Wells Pharmacy Network inherited these problems while knowing about them. Obviously problems would arise from this. For example, from the summer of 2013 to the summer of 2014, the FDA conducted their scheduled inspections of the Wells Pharmacy Network compounding facilities. During these investigations the FDA found many violations like “serious deficiencies in [their] practices for producing sterile drug products, which could lead to contamination of the products, which put patients at risk,” “invalid prescriptions for individually-identified patients for a portion of the drug products you produce,” [9] and many others.
Two years later in 2016, a major recall of 616 recently produced products at the time. The recall was prompted by another concern about sterility from the FDA. The FDA did not force the recall meaning Wells Pharmacy made the call themselves. In the recall announcement The compounding lab claimed that "no vial or portion of any lot of these medications has been found to be nonsterile" [3] and gave the excuse that their facilities were “undergoing an expansion and enhancement and the FDA would have preferred that we stop production during construction” [3]. Some of the dots do not connect because why would a compounding pharmacy still be producing drugs in areas of construction in the first place. In addition, why would the company recall products that they have claimed to not be nonsterile. It seems as though they are trying to cover their tracks by being misleading in their recall.
COVID19 Scandal:
After all of these scandals and more, Wells Pharmacy Network had their most recent scandal involved with the COVID19 pandemic. Wells is known for wellness, anti-aging, weight management, urology, sexual health, thyroid and adrenal health, and veterinary compounded pharmaceuticals. So it seems like viruses like influenza and SARS are not in their field of research, or expertise. It's odd to see them develop a treatment/cure for COVID19 right in time for the summer of 2020, right when the US was months into a quarantine/lockdown because of the COVID19 pandemic.
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| Image from Wells Pharmacy Network website. |
This is when Wells Pharmacy came out with their brand new product called Quad Immune. Quad Immune was announced by a doctor that did not even work on developing the product. This doctor is Dr. Gordon Crozier, “a board-certified physician, speaker, lecturer, and best-selling author” [6]. For the online webinar announcement for the product, Dr. Crozier discussed “that there has never been a better time to optimize you and your patient’s immune system.” [6]. No better time to advertise a “treatment” for a virus, than during a worldwide pandemic. Quad Immune consists of the four drugs, “Thymosin alpha 1, Zinc, Vitamin D, and Vitamin B Complex with Vitamin C. Quad Immune supports the human immune response against viral infections, and Thymosin alpha 1 has been shown in studies to help regulate pro-inflammatory cytokine storms” [6]. Wells Pharmacy Network’s product catalog for 2020 explains the four substances included in the Quad Immune package.
Image from the official 2020 catelog.
The Thymosin Alpha 1 (TA1) injection is the main drug in Quad Immune. The catalog states “studies have demonstrated improvements in immune system cell subsets and the potential of TA1 for the treatment of a range of diseases. Thus, Thymosin Alpha 1, due to the immune stimulating effects exhibited by TA1, may have utility for the treatment of age or disease related immune suppression” [11]. The biggest problem with these claims about the TA1 injection is that it has never been approved by the FDA to treat any illness, disease, or virus. On the bottom of the Thymosin Alpha 1 injection page to the catalog the fine print says that “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” [11], meaning that everything they have claimed about the injection has not even been proven. So in the official catalog, they are advertising unapproved information that could be very harmful. 
The thymosin alpha-1 injection.
If one were to look into thymosin alpha 1, they would find the several side effects that can happen even if someone uses the injection as instructed. Thymosin alpha 1’s generic brand name is Zadaxin. Zadaxin has been prescribed to patients in order to treat hepatitis B. These same patients have experienced common side effects such as “redness and discomfort at the injection site, muscle atrophy, multiple joint aches and pains, and swelling and rash of the hand” [8]. Along with the studies showing thymosin alpha 1 improving the immune system’s functions, there is also a mechanism of the injection that has done the opposite. In some studies, the drug has shown to have “a feed-back dampening effect on the immune system, leading to increases in regulatory T cells and a decrease in the production of inflammatory cytokines” [10]. From the several studies testing the injection, there is not much certainty in what its true functions are. This is why the drug has yet to be approved by the FDA.
Wells Pharmacy Network was not the only company making these claims about TA1. There were “more than 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” [2] including Wells Pharmacy Network. The majority of these 30 companies promoting thymosin alpha-1 as a treatment for COVID19 “do not specialize in infectious diseases, but rather focus on plastic surgery or promote ‘wellness,’ ‘anti-aging’ and ‘regenerative’ medicine” [5] just like Wells. It seems like these companies are making claims that they are not qualified enough to make. The problems with this widespread advertisement all across the country during a worldwide pandemic is that every one of their patients are worried and anxious about the coronavirus and will most likely try anything to keep themselves safe. They will put their trust into these companies that look like they know what they are talking about and be manipulated to purchase some drug that could possibly harm them. It also“can make it even more difficult for patients to figure out whom or what to believe, especially if the information is coming from doctors” [2]. On top of putting their health at risk, buying thymosin alpha 1 could also put their wallets at risk since ‘the cost of the drug can run up to $400 for a month's supply, all out of pocket” [2]. Social media has made advertising a lot easier as well for these companies. In April 2020, Wells Pharmacy Network “promoted thymosin alpha-1 on Facebook along with the hashtags "#coronavirus" and "#covid" [2] in order to reach a wider audience and make more money off of their misinformation.
Because thymosin alpha-1 is not approved by the FDA, it's “unavailable through pharmaceutical companies in the U.S. Instead, it's reaching consumers through an alternative source: compounding pharmacies” [2]. A compounding pharmacy creates custom medications from base ingredients for patients. Rather than providing a pre-mixed formula, the compounding pharmacist begins with base drugs, combining and preparing them to fit the individual patient's needs. Compounding comes with its own problems, however. Even though the base ingredients are from the FDA they do “not test or evaluate drugs made in those pharmacies. So even though those drugs may be legally prescribed, they are never considered FDA approved" [2]. “The medications used in compounding formulas, when broken down, are virtually identical from a chemical perspective. The only real difference is that compounding pharmacies combine the ingredients in-house to meet the individual patient’s needs” [1]. According to many experts in the field, compounding pharmacies are “largely unregulated” [7] and frequently run into scandals like these.
Ethical Theory Analysis:
Stakeholders:
The main stakeholders in this case are the patients and employees of Wells Pharmacy Network, the FDA and FTC and Wells Pharmacy Network as a whole. The patients are the ones who are getting put in harm's way so they are the ones who have the most to lose in this terrible situation. Next is the employees and Wells Pharmacy Network itself because if this scandal gets really big, they could lose money, customers, and/or their jobs. And lastly the FDA and FTC need to be worried about this situation and other situations like this because the health and safety of the patients and the responsibility of keeping compounding companies like Wells Pharmacy Network in check is all on their shoulders. If they drop the ball like this more they could lose reliability.
Individualism:
The theory of individualism states that the only goal a business has is to maximize their profits for themselves and their shareholders, but to do it within the law. The only direct goal of any business is to profit, but there's still an obligation to be lawful in their practices.
Wells Pharmacy Network was trying to make themselves look better by saying they had the drug that would make one immune to the coronavirus. They were hoping they could make a profit off of this misinformation, and probably did so, but this was an illegal action. These kinds of actions violate the Federal Trade Commission Act, also known as the FTC Act. Under this Act, the FTC is empowered to prevent unfair methods or practices that affect commerce; seek monetary relief and other relief to consumers that were harmed or injured; enforce rules against acts or practices that are unfair or deceptive, and establish requirements designed to prevent such acts or practices; conduct investigations relating to the organization, business, practices, and management of entities engaged in any type of commerce; and make reports and legislative recommendations to Congress and the public [FTC Act]. Wells Pharmacy Network Violated this act by using misinformation about the TA1 injection to promote its sale. This action is deceitful and unfair to the customers and patients of the compounding pharmacy, so Wells has broken this fundamental law of the FTC. This is an unethical and impermissible action in an individualism sense even if they were trying to maximize their profits from the drug.
Utilitarianism:
In utilitarian theory, an action is deemed ethical if it promotes happiness to the maximum number of people. Happiness is the only thing that has intrinsic value and should be brought out to all stakeholders and doing so impartially for the long run. On the other hand, if an action does not bring the most amount of happiness or even harms any of the stakeholders, it is considered impermissible to a utilitarian.
Wells pharmacy was probably very happy that they could fool a few customers into buying the immunity from covid, making themselves a little bit of money in the short run, but in the long run the customers are going to be unhappy with them when they find out it was all just a ruse. So in the long run, this scandal could cause Wells Pharmacy Network to lose business or even get shut down for good. The worst part of the compounding pharmacy’s actions is that it put the recipients of the TA1 injection at risk. Several studies have shown no definitive pros to using thymosin alpha-1 but have shown some side effects that could ultimately hurt the person taking the drug. To a utilitarian, if anyone is being harmed from an action, that action is deemed impermissible.
Kantianism:
Kant’s theory says that it is wrong for one to manipulate and exploit people for their own advantage. The basic principles of Kantianism are to act rationally, to help others make rational decisions, to respect people, to be driven by one’s own goodwill, and to do the right thing because it is right. According to Kant, if an action follows these principles, that action is considered permissible. The test that is used to see if an action is permissible or impermissible is called the Categorical Imperative. The Categorical Imperative is based on the Formula of Humanity which states that it is wrong to use people as a mere means to get what you want out of them because it exploits them.
. Wells Pharmacy Network’s actions during the COVID19 pandemic would fail the Categorical Imperative test. They manipulated their customers with lies to make them buy a phony coronavirus treatment. They found out a way to “misuse patients' trust to help create a market for drugs that haven't been proven to work” [2]. These deceitful actions from the compounding company use the patients as a mere means to make a little extra cash during a tough time. Overall, Wells used their patients as objects in order to get what they wanted out of them, money.
Virtue Theory:
Virtue Theory focuses on four main virtues that include courage, honesty, temperance, and justice. Having courage means one will take risks and stand up for what is morally right. Being honest is agreeing to be truthful with everything one does in their life. Temperance is having self-control in any situation where one wants to do something that could be morally wrong. Justice defines what is lawfully right and fair in life. All four of these virtues must be met in order to be a virtuous or ethical person.
We can apply virtue theory to Wells Pharmacy Network to see if they are ethical in their practices or not. The company was courageous in one way by taking a risk to promote an unapproved drug to the public, but this was a risk taken in the wrong direction. Since they did not stand up for what is morally right in this situation by not acknowledging they had done something morally wrong and also not trying to initiate a plan to undo this wrongdoing, Wells Pharmacy Network cannot be considered courageous. The most obvious problem with the compounding pharmacy is that they were never honest with their patients, the FDA and FTC, nor with themselves. They purposely lied to try to make a profit. The pharmacy had no temperance in this situation since they couldn’t stop themselves from being unethical and manipulative just to make a quick buck. They saw an easy opportunity to take advantage of their patients and they couldn’t stay away. Lastly, they do not demonstrate the characteristic of justice since they were not lawful or fair in their practices during the pandemic. They violated the FTC Act which breaks the law, and they used their customers’ insecurities about the pandemic against them which was unfair. So according to virtue theory, Wells Pharmacy Network has none of the four virtues needed to be ethical, therefore they are not.
Justified Ethics Evaluation:
In my opinion, Wells Pharmacy Network should not be in business anymore. They have received too many second chances for some reason after all of the problems they have caused over the past decade. They began prescribing thymosin alpha-1 early on in the pandemic to give people something that they can do so that they felt like they weren't helpless. But in the long run they were potentially putting their own patients at harm. I think promoting thymosin alpha-1 as a coronavirus treatment was unlawful and unethical because those such claims were not supported by reliable scientific evidence. The whole point of putting a drug on the market is that there are several good, reliable, and respected scientific studies proving that the drug really helps to treat or cure some medical condition or illness. Peoples’ health, wellbeing, and safety are on the line, and that should not be put on the back burner just to make more money. That is just not right.
On top of this, I believe there are several problems with compounding pharmacies, from the non-FDA approved drugs, to the several safety hazards and unsanitary conditions. I think compounding facilities should not be trusted since almost every company of this kind has a history that is very similar to Wells’. Something just doesn’t feel right to me that ingredients get put together by people other than those working for the FDA. I think there needs to be a lot more regulation in this field for the health and safety of everyone.
Action Plan:
There are many steps Wells Pharmacy Network needs to take if they even want to get close to repairing their image. The pure number of scandals they have alone makes them look bad. I think a good start for Wells could be to follow the law entirely, so no cutting corners or loopholes. That type of behavior from professionals is unexceptable. Another big thing they need to work on is being completely transparent and honest with their patients. They state on their website that patient safety is their number one priority, but that could not be further from the truth.
A new mission statement for the company should be “We vow to keep our patients safe, happy, and healthy by using the most reliable and trustworthy science around.” This statement is much less vague than the mission statement they have now, which is an improvement in itself. The new statement also ensures that there will be no manipulation or unfairness, and that all of the patients will be in good hands.
Wells Pharmacy Network could also follow some core values in order to become more ethically efficient in their actions. Their new core values should involve authenticity, patient safety, responsibility, and intelligence. The company really needs to work on being authentic and honest because that has been their biggest struggle during their several scandals. Being honest will be challenging for them because of all of the easy loopholes that come with being a compounding pharmacy. In my opinion focusing on patient safety is the most important thing for them to do. If they keep putting the public in harm's way, they could get shut down for good. If they want to be taken seriously from this point on, they will need to be responsible and act like real professionals. And finally, Wells Pharmacy Network needs to be more intelligent when making decisions. If they do not, the state of the company could be destroyed. Changes in policies, like a new mission statement and four core values need to take place if Wells wants to have any kind of future as a successful company.
A good thing for the company could be finding completely new management and other higher positions like CEO. The new employment should be from the same field but should also be known for being trustworthy to patients. Wells needs to rethink their marketing strategy as well. Using the marketing tools they have now makes them break the laws enforced by the FTC. They have to stop using deceitful and unfair misinformation when marketing their products. If Wells follows a plan similar to this, they could mend up their relationship with their patients and possibly become more successful and make even more of a profit off of doing good instead of doing bad.
Resources:
[1] Apothecary, Archway. “3 Differences Between Compounding & Retail Pharmacies.” Archway Apothecary, 28 Aug. 2019, archwayapothecary.com/3-differences-between-compounding-retail-pharmacies/.
[2] 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.
[3] Goldschmidt, Debra. “Wells Pharmacy Network Recalls Hundreds of Products.” CNN, Cable News Network, 22 Sept. 2016, www.cnn.com/2016/09/22/health/wells-pharmacy-network-recall/index.html.
[4] Indest III, George F. “Are You Facing Allegations Against Your Medical License?” The Health Law Firm, 22 Aug. 2012, www.thehealthlawfirm.com/blog/posts/franck-s-pharmacy-closes-its-doors-compounding-lab-becomes-wells-pharmacy-network.html.
[5] Krishnamoorthi, Raja. “To FDA and FTC Re Thymosin Alpha-1.” Received by The Honorable Dr. Stephen M. Hahn and The Honorable Joseph Simons, Oversight.house, Subcommittee on Economic and Consumer Policy , 28 Oct. 2020, oversight.house.gov/sites/democrats.oversight.house.gov/files/2020-10-28.RK%20to%20FDA%20and%20FTC%20re%20Thymosin%20Alpha-1.pdf.
[6] Pantoja, Eduardo. “Wells Pharmacy Network Is Proud to Host a Webinar with Dr. Crozier on Quad Immune.” Wells Pharmacy Network, 24 July 2020, www.wellsrx.com/webinar-quadimmune/.
[7] Reynolds, Matt. “Compounding Pharmacy's Drug: Accused of Blinding Patients.” CNS, 11 Mar. 2013, www.courthousenews.com/compounding-pharmacys-drug-accused-of-blinding-patients/.
[8] “Side Effects of Zadaxin (Thymalfasin), Warnings, Uses.” RxList, RxList, 3 Mar. 2009, www.rxlist.com/zadaxin-side-effects-drug-center.htm.
[9] Turcovski, Susan M. “Warning Letter FLA-15-07.” Received by Benjamin H. David, President, CEO of Wells Pharmacy Network, Web.archive, 10 Nov. 2014, web.archive.org/web/20170406034011/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423242.htm.
[10] Tuthill, Cynthia W, and Robert S King. “Thymosin Alpha 1–A Peptide Immune Modulator with a Broad Range of Clinical Applications.” Journal of Clinical and Experimental Pharmacology, 2013, doi: 10.4172/2161-1459.1000133.
[11] Wells Pharmacy Network. Product Catalog, Wells Pharmacy Network, 2020, irp-cdn.multiscreensite.com/1571d9a1/files/uploaded/Catalog2020-V2.pdf.
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