Tuesday, December 15, 2020

Web of ‘Wellness’ Doctors Promote Injection of Unproven Coronavirus Treatment: Lindgren Functional Medicine (2019-2020)

 Controversy

Lindgren Functional Medicine is a medical practice in Green Bay, Wisconsin that focuses only on functional medicine. Functional medicine is “patient centered, and takes the approach of treating the whole person - taking the time to understand what has triggered the condition, eliminate those elements, and allow healing to begin from within” and “treats chronic conditions and imbalances within the body usually glossed over by conventional medical approach”[Lindgren.Health]. In doing this, the doctors solely focus on personalized, focused care where they gather information to determine root causes of whatever sickness they may be faced with. Ultimately by doing this, these doctors can draw up a healthy living plan that would address the basic physical needs such as nutrition, sleep, and exercise, as well as mental and emotional [Cleveland Clinic]. Dr. Kristen Lindgren runs her own practice, along with her associate Ivy Leasum. At Lindgren Functional Medicine they mainly focus on and specialize in the areas of womens and mens health and aging, sexual health, digestive health, adrenal rebalancing, and weight optimization. They use procedures such as stem cell therapy, bioidentical hormone therapy, hormone pellet therapy, and more. This type of medical approach appeals to many different types of people, including people who do not like taking prescription drugs, people with chronic diseases such as diabetes, heart diseases, and cancer who would like a more natural approach, temporary illnesses such as a virus or bacterial infections, and patients who have tried everything else and have become hopeless. There are multiple people under scrutiny in the case at hand, however our focus is Dr. Lindgren and her practice. Right now we are in a global pandemic which is affecting every single person's daily life. This illness is called the Coronavirus-19, “COVID-19 is caused by a coronavirus called SARS-CoV-2. Older adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness” [CDC COVID Data Tracker].Currently in the United States (within the past seven days), there have been “11,465,017 total cases, 48.8 cases in the past seven days (per every 100k), and 249,436 total deaths” [CDC COVID Data Tracker]. This shows that the virus is dangerous, contagious, and deadly. And since this virus is quite literally brand new, it has never been researched since this past year. So, unlike the flu or a bacterial infection, there was no way of knowing what it was, how it fully affected the body, or even how to treat it. Since this illness was killing people left and right, people were desperate for any type of preventative treatment. This is where the dilemma of Lindgren Functional Medicine comes in. A number of web ‘wellness’ doctors, including Dr. Lindgren, were posting on social media, including instagram and facebook, about how getting regular injections of the drugs called thymosin-alpha 1. This drug thymosin-alpha 1 is “Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness” [ClinicalTrials]. Although Lindgren had stated in her video that “the drug had not yet been studied as a treatment for COVID-19 and that she characterized the drug as one way to support the immune system”[Dreisbach, T.]. However, it was being advertised as “FDA Approved” and how it would make the virus easier to fight off by other web wellness programs such as Fradin-Read. On the other hand, there have been clinical trials with thymosin alpha-1 and the elderly with the prevention of COVID-19. In these clinical trials they have found that “a course of Ta1 administered to individuals at high risk for COVID-19 infection (hemodialysis patients 60 years and older) will reduce the rate of COVID-19 infection and severity of infection with COVID-19, compared to untreated individuals in the same hemodialysis units with comparable risk” [ClinicalTrials]. Although this is just a clinical trial, there still is some scientific evidence that this drug does potentially have the ability to have some preventative effect on coronavirus-19. The Federal Trade Commision and the FDA warned three companies that promoting thymosin alpha-1 as a coronavirus treatment is "unlawful" because such claims are "not supported by competent and reliable scientific evidence," and demanded they remove those claims within 48 hours [Dreisbach, T.]. These notifications to the companies are often just warnings to take these commercials and postings down, and once they are taken down there is nothing else these agencies do except to take note of the infraction. However, the FDA and FTC can also take individuals to court if the warnings are not taken seriously and/or legal actions have to be taken. Dr. Lindgren followed the FDA’s request and took down their post relating to thymosin-alpha-1 and her youtube video had its privacy settings turned on. In an interview Lindgren had reported that she was not worried about the authorities or the FDA in any way. So, the only repercussions Lindgren Functional Medicine had was that they had to take their posts claiming coronavirus treatment down, or set it to private.                                                                                              


NPR Investigation: Web Of 'Wellness' Doctors Push Unproven COVID-19  Treatment : NPR

Stakeholders

A stakeholder is a person with an interest or concern in something, especially a business. The stakeholders in this case would be Dr. Lindgren, Lindgren Functional Medicine, and the independent pharmacy companies that sell thymosin alpha-1 to other functional medicine practices. The people affected would be Ivy Leasum and all of the patients that they treat at the medical practice.                            

Individualism 

According to Individualist Theory, a business is acting within ethical standards when it makes a profit for its stockholders or focuses on their interests, but doing so while pertaining to the laws of society and respecting human rights. Lindgren Functional Medicine, Dr. Lindgren’s practice seems to be a decently successful practice with strong and personal bonds with each and every one of their patients. However, Lindgren did break the law when commercializing, posting on social media, and false marketing about thymosin alpha-1 being used as treatment for the coronavirus-19 illness. Another part of this dilemma that might be a problem, is the thymosin alpha-1 in itself is not a drug approved by the FDA. So, the question arises, is it morally/ethically wrong to prescribe a drug injection of a drug that is not yet approved by the FDA at a private practice. There is not enough evidence to show if Lindgren informed her patients on if this drug was approved by the FDA or not. 

Utilitarianism 

According to Utilitarianism, an action is deemed ethical if it promotes all-around happiness to all parties affected. Happiness is the only thing of intrinsic value in the minds of Utilitarians. Technically, that was Lindgren’s goal ; to make everyone as happy as possible during a time of panic. People were looking for a treatment for the illness spreading across America, and Lindgren Functional Medicine practice was claiming to have an injection that would make the virus ‘easier to fight off’. So, in turn even though the Lindgren Functional Medical practice was deceiving their patients, they did it to make them happy. On the other hand, if one of her patients were to contract COVID-19, and say suffer very bad symptoms or even face death, her patients would no longer be happy. They would probably feel distraught at the fact that their doctor lied to them, and it would probably turn out to be a negative effect for the medical practice. A utilitarian would look at this case and say it is unethical. Even though happiness would be maximized by giving people a drug they thought would prevent the illness, their happiness was not maximized for everyone when the truth came out and there was no verified scientific proof on the drug being used to prevent coronavirus, and the drug not being FDA approved. 

Kantianism 

Kantianism is based on the values that ethical activity is only possible when the acting party conducts themselves rationally in the goings-on of society. A business entity should never consider itself exempt from the rules. There is not enough information on the case to tell if Dr. Lindgren was telling her patients that thymosin alpha-1 was not FDA approved and there was no credible research suggesting that this drug could help to treat COVID-19 in any way, preventative or therapeutic. Dr. Lindgren was using her patients as a means to an end. She saw the pandemic as an opportunity to profit off of her patients. By commercializing and advertising thymosin alpha-1 as a COVID-19 type of treatment, she was drawing in her patients and using them to profit.  Under the Kantiansim view, it would be seen as unethical because she was using her patients to profit off of, not knowing truthfully if this drug would prevent them from getting the disease that is spreading across the nation.  

Virtue Theory 

Virtue Theory is based on four virtue characteristics. If a business entity acts in a way that fits the four characteristics, it is, therefore, acting ethically. The four virtue characteristics are courage, honesty, temperance, and justice. The courage characteristic represents an entity's willingness to take chances, and to stand up for what is right. The honesty characteristic represents an entity's willingness to be truthful with the public and all other parties involved with and affected by the business activity. Temperance represents the ability of the entity to set realistic expectations and justice represents hard work and fair practice. Lindgren Functional Medicine upholds none of these four characteristics. Lindgren did not act with courage and stand up for what was right when she lied to her patients through false advertising about a drug that was not even approved by the FDA. Lindgren did not act with honesty either when they lied, and when they did not add another post stating that their statements were false. They continued on and let people believe what they previously saw posted. Lindgren also did not act with temperance because they were not being fair to their patients, not being fully open or truthful. And lastly, there was no justice made to their patients that is known to the public.

Action Plan 

There are several different ways that Lindgren Functional Medicine can be ethical. Firstly, They should own up to their patients, that what they claimed was false, however Dr. Lindgren believed that it could possibly help the body fight off the virus due to the research supporting thymosin alpha-1. Next, the person in charge of social media should be reprimanded or replaced so that an incident of false claims does not repeat itself. The company can remain profitable and gain revenue by changing their marketing tactics. Instead of the illegal post they made, they can advertise different treatments that can help the body heal, recover, and fight off other illnesses similar to the coronavirus-19, as well as adding a warning onto any treatment that might not yet be approved by the FDA. This way, she can increase her profit and revenue by continuing to treat her patients at the same time by remaining ethical and fully and truthfully inform them on what they are getting. 


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