23andMe: Sharing Genetic Data with Pharmaceuticals (2018)

23andMe: Sharing Genetic Data with Pharmaceuticals (2018)

Case Description

23andMe was founded by Ane Wojcicki, Linda Avey, and Paul Cusenza in 2006. The company was founded to provide genetic testing and interpretation to customers. This information includes ancestry and genetic information about one's self. 23andMe developed an autosmal DNA testing kit that was named "Invention of the Year" by Time magazine in 2008. This technology is now the standard testing kit for the industry among major competitors and 23andMe itself. The company now offers two products, one for just ancestral DNA analysis, and a
second (more expensive) product that offers both ancestry and genetic information to the consumer. By spitting in the provided test tube, 23andMe can provide over 125 health reports as well as providing information for 11 genetic diseases based on genetic mutations. The 11 genetic diseases that 23andMe can provide information on if one is at risk have been approved by the FDA over a several year period and may expand to include more over time.

When one purchases a testing kit from 23andMe, the individual has a choice to make. This choice is whether or not to consent to participation in 23andMe's research study. This consent can be changed at a later date through the company's website through a simple opt-in / opt-out tool. However, it can take up to 30 days for this change to take full effect and one's genetic information is removed from any research studies. For the 5 million individuals as of July 2018, 80% of these users have given consent to be included in research studies. When one is involved in this study, their information is de-identified and included in the summarized report that 23andMe will share with any partners involved in the study. From here, individuals can be contacted by either 23andMe or a partnered institution or business to see if that individual is interested in being recruited for a medical study. To date, 23andMe has published over 100 scientific papers that have advanced the medical community. 

The partnerships that 23andMe have formed involve both medical institutions such as Massachusetts General Hospital and pharmaceutical companies. Outcry has arisen by customers over the partnerships with pharmaceutical companies. The first major pharmaceutical company to partner with 23andMe was Pfizer. Pfizer is a U.S. pharmaceutical giant announced their partnership with 23andMe on January 12, 2015. This partnership, like GSK, was to advance medical research through collaboration that uses 23andMe’s extensive database. This collaboration has allowed Pfizer to speed up recruitment process on several studies. Pfizer was able to recruit a total of 15,000 individuals for two research studies: 5,000 for Lupus disease, 10,000 for Invasive Meningococcal Disease. The second major company that has partnered with 23andMe to utilize their extensive genetic database is Lundbeck. This Danish company is collaborating with 23andMe to recruit 25,000 participants for research between genetics, cognition, and psychiatric disorders. Within a span of 3 months after this partnership, Lundbeck was able to recruit the 15,000 individuals for a Major Depressive Disorder study as well as another 10,000 individuals for Bipolar Disorder (BPD). The third company, GSK, is the cause of much of the outcries about 23andMe's partnerships. In 2012, GSK pleaded guilty for promoting drugs for unapproved uses, failure to report safety data, and kickbacks to physicians in the United States that amounted to a $3 billion settlement. The company has since then made strides to gain back trust and respect within the industry. In 2018, GSK and 23andMe announced a four year collaboration (optional 5th year, funding split 50/50). This partnership is largely to further research GSK's research in the LRRK2 gene variant that causes Parkinson's in 1% of diagnosed Parkinson's cases. The ability to speed up research time in an industry where 9 out of 10 drugs never receive FDA approval can save companies a tremendous deal of money and can give new hope to those afflicted by genetic diseases.

Stakeholders

There are various stakeholders in this case. 23andMe is the center of the controversy, as well as any company or institution that 23andMe has partnered with. Those who have used 23andMe and have chosen opt-in are directly affected as well as those consumers who did not realize they had given consent within part of the terms and conditions that the consumer agreed to. The populace as a whole is a stakeholder in this case because 23andMe's partnerships have dramatically sped up the research process and has increased the likelihood of novel treatments being created and used within ones lifetime. Those who are suffering from genetic diseases, and those who are affected from one having such disease have great interest in this case and the scientific findings resulting from 23andMe's actions.

Individualism

23andMe according to Individualism acted rightly. Individualism states that a business’s obligations are to maximize profits within the rules of the game (within the law). Milton Friedman argues that the company should “use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition, without deception of fraud” (DesJardins, 54). The first measure of whether or not 23andMe acted according to Individualism is if the company is maximizing profits. 23andMe fulfills this criteria as the company is utilizing all of the company resources in order to maximize profit. Patrick Chung, a 23andMe Board Member, discussed in an interview with FastCompany that 23andMe once it has formed an extensive enough database, the company is able to use that database to become the "Google of personalized health care". To do anything but use the extensive database that was provided to the company through individuals would be in violation of both Individualism and the company's own goals. The second measure of Individualism is whether or not the company violated any laws while maximizing profits. The company sidestepped the need for laws regarding genetics (very few and outdated) by asking for customers to choose whether to consent or not to participating in research studies. The individual is able to change their mind at any point and within 30 days their effects will take full effect. Participation in anything past being simply a customer is completely optional. Therefore, 23andMe is acting according to Individualism as it simultaneously maximizes profits and follows the laws that are currently in place.

Utilitarianism
23andMe according to Utilitarianism acted rightly. Utilitarianism states that a business should maximize happiness in all stakeholders. To do this one should choose the best action among alternatives that gives the best consequences to involved parties both now and in the future. So, we must evaluate to see if 23andMe's actions resulted in the best consequences for all involved. 23andMe is maximizing their own happiness in this case as the company can follow their plans to advance medical research and profit from the sharing of genetic information through partnerships. The partners in this case are now able to use 23andMe’s genetic database and are able to greatly speed up early research phases of treatments in the pursuit of future profits. Customers regardless of their consent decision receive the information they desired to learn from the testing kit. Those who agree to participate in research studies now have the opportunity to speed up medical findings about their respective diseases and are given hope that from this, novel therapies and medications can be developed. The last major shareholder is the general public. The general public can greatly benefit from 23andMe’s actions without consequence as any medical findings or therapies developed will benefit any individual suffering from the disease(s) that are being studied.

Kantianism
23andMe according to Kant acted morally permissible. Kantianism is founded on the principles of good will and respecting others. In other words, one should act in a way that they treat humanity, whether them self or others, as an end and not just a means (formula of humanity). 23andMe respects customers by going beyond what is legally required and protect their valued and sensitive information with high security including encryption. The company also tries to be as transparent as possible in their processes to show that there is a reason to participate and that it is safe. Information that is shared with other companies are de-identified and presented in a summarized format that tells the partnered institute about the individual or group. Then from here, individuals can be contacted for recruitment in scientific studies and if the individual agrees it is up to them to share their information. The company goes above what is required to do because the customer and the resource the customer brings is valued by the company. The maxim for 23andMe would be: 23andMe will ensure that customer data is secure, and the company is transparent in order to maintain the trust of customers so that the company is able to continue medical research. Therefore, 23andMe's actions are both morally permissible and for the right reasons.

Virtue Theory
23andMe according to the Virtue Theory acted rightly. Virtue ethics seeks a detailed description of character traits that would culminate in a good and full life. Traits that allow for good functionality are virtues and traits that prevent functionality are vices. The traits that allow for good functionality help one to live what is a considered a good and full life according to Virtue Theory. There are four main virtues for this theory consisting of: courage, honesty, temperance, and justice. Courage virtue does not necessarily apply to this case. 23andMe displays honesty by not deceiving their customers by explicitly stating what the company will and will not do with the data provided by consenting customers. The company also displays temperance by maintaining control over their actions. There is no requirement stating that 23andMe has to put the high levels of security and protections in place, but the company has opted to do so anyways. 23andMe displays justice by implementing fair policies for the company and research studies. There is not a mandate to treat this information fairly as the laws in place are severely outdated and do not cover a significant portion of 23andMe’s and other competitor’s practices. From this we can see that 23andMe acted in accordance to three of the four virtues (Courage not applying) and has high functionality which should result in a good business.

Justified Ethics Evaluation

In my opinion, 23andMe is acting rightly in this case, but they are challenging the typical business model for both medical companies and business companies. 23andMe is a blend between a consumer’s product-based company and a research company and there are people who believe these entities should be separated. For now though, the company has shown remarkable and unrequired effort to protect the rights of consumers, especially those who are a part of the research studies. Also, the company has stated since its early days that the main goal of the company is to utilize the genetic database that is compiled to become the google of personalized health care. The meaning of this is to use the database that is conducted to perform analysis to find potentially new medical findings that will drive the company forward. It is difficult to find any major wrongdoings in the company. My only critiques on the company and its actions are that the company walks a fine line between a business and a research company as well as having some policies that are vague, are not clear in wording, or are outdated.

Action Plan
23andMe has acted rightly according to the ethical theories used. While their actions and motivations have warranted a pass for the company, the company struggles with conveying their information concisely rather than the information being spread out across the company’s platforms. The company can take steps to strengthen their ethical position and potentially increase profits.

The first step that the company can take is to remove the 30-day period before an opt-out is fully registered and active in the system. The consumer should be in control of whether or not their genetic data is used in any way. The company should also consider adding clarity to the consent waiver form and opt-out ability. There appears to be confusion from the customers on how to opt-out. Additionally, the company should begin a marketing campaign highlighting the company’s partnerships with medical institutions and research findings. Finally, the company should consider asking congress to update genetic information protection laws in order to remain the industry leader for information security. 

The company should also strive to live by an updated set of core values. These core values should be transparency, honesty, customer safety, integrity, respect. People who consent to 23andMe using their genetic information for research studies should have no reason to fear that the company may misuse or take advantage of the provided information for the sole benefit of the company.

This pan will promote profits and strengthen the ethics of the company. The company will benefit from the marketing campaign that highlights the good resulting from the company's actions will diverting attention away from customer fears that could slow the company. Trust has been damaged in this case because the uninformed public typically only hears the negative of actions rather than the positives. The opportunity to regain trust from a marketing campaign as well as a revamp of company policies should put the company is a position to move forward in both an ethical and profitable way.

Dan Cushing

References:

“23andMe Announces Collaboration with Pfizer Inc. to Conduct Genetic Research Through 23andMe's Research Platform.” 23andMe Media Center, mediacenter.23andme.com/press-releases/23andme-pfizer-research-platform/.

“23andMe Now Enrolling for A New Genetic Study on Depression and Bipolar Disorder.” 23andMe Blog, 2 Aug. 2017, blog.23andme.com/23andme-research/23andme-launches-new-genetic-study-depression-bipolar-disorder/.

“Choose Region and Then Country.” Trastorno Bipolar I, www.lundbeck.com/global/about-us/features/2017/flying-start-to-huge-depression-genetics-study.

Ducharme, Jamie. “23andMe's GlaxoSmithKline Partership Raises Privacy Concerns.” Time, Time, 26 July 2018, time.com/5349896/23andme-glaxo-smith-kline/.

GSK and 23andMe sign agreement to leverage genetic insights for the development of novel medicines. (2018, July 25). Retrieved from https://www.gsk.com/en-gb/media/press-releases/gsk-and-23andme-sign-agreement-to-leverage-genetic-insights-for-the-development-of-novel-medicines/

Herper, Matthew. “Surprise! With $60 Million Genentech Deal, 23andMe Has A Business Plan.” Forbes, Forbes Magazine, 6 Jan. 2015, www.forbes.com/sites/matthewherper/2015/01/06/surprise-with-60-million-genentech-deal-23andme-has-a-business-plan/#77eb1f422be9.

Herper, Matthew. “23andMe Gets $300 Million Boost From GlaxoSmithKline To Develop New Drugs.” Forbes, Forbes Magazine, 25 July 2018, www.forbes.com/sites/matthewherper/2018/07/25/23andme-gets-300-million-boost-from-glaxo-to-develop-new-drugs/#44904c8c3213.

Tirrell, Meg. “GlaxoSmithKline Strikes $300 Million Deal with 23andMe for Genetics-Driven Drug Research.” CNBC, CNBC, 25 July 2018, www.cnbc.com/2018/07/24/glaxosmithkline-23andme-team-up-on-genetics-driven-drug-research.html.