Aegis Compliance & Ethics Center, LLP
The Ethics Surrounding Commercial Genetic Testing
While the increasing popularity of commercial genetic testing may excite some, many ethical concerns arise from the powerful information contained in genetics. Such concerns stem from apprehension over patient privacy, asymmetric information in the insurance market, as well as discrimination and regulation of these tests. While many possible risk exists, the market continues to lack regulation.
Today, a common misconception remains that researchers will keep genetic test results private. One might point to the Health Insurance Portability and Accountability Act (“HIPAA”) as a safeguard to ensure such privacy. However, the reality proves the opposite. HIPPA does not prevent companies from both sharing and selling patient data if the information becomes “scrubbed” of any identifying information. However, even the co-founder of 23&Me (a company named for the number of chromosomes in a human cell) has pointed out that “It’s a fallacy to think that genomic data can be fully anonymized.”
While the general population may remain content with having their “anonymized” genetic information out in the world, many have found that due to the unique nature of DNA, researchers can easily re-identify the information. In 2013, a study conducted at Harvard re-identified between 84% and 97% of a sample of genetic volunteers using public record information such as gender, postal code and date of birth. The ease of re-identifying genetic information demonstrates the misunderstanding surrounding private genetic testing.
Knowledge is Power
While privacy of genetic information concerns the public, the insurance industry expresses fear over the increased asymmetric information flooding the market. Asymmetric information arises when one side of a market (i.e. consumers) has information the other side lacks (i.e. insurance companies). When a consumer has access to their personal genetic information, they may know that they possess an increased risk for developing certain disease types, such as an aggressive cancer. In many cases, an insurance applicant does not disclose this information and can purchase a life insurance policy or even critical illness coverage, thus leading to adverse selection.
All signs indicate disruption in the insurance market, prompting increased premiums or simply wiping the market altogether. However, some argue that genetic testing could become a positive force in the insurance market, especially testing that helps identify early signs of many diseases which keeps consumers healthy. However, many suspect that the current knowledge must further develop in order to know that taking a certain medication will stop a disease that a person has the potential to develop.
In 2008, Congress passed the Genetic Information Nondiscrimination Act (“GINA”) to prevent health insurers from requiring genetic information to make decisions regarding health insurance eligibly and premiums. However, this past March a House committee took steps to eliminate GINA’s protections. Specifically, with the HR 1313 bill, an employer could require genetic information as part of a ‘workplace wellness’ program. An employee could face a penalty if they choose not to participate.
Thought to aid in making employees healthier and reduce health care related costs, the scientific community, as well as many ethicists, largely dispute this claim. Arthur Caplan, the director of New York University’s Division of Medical Ethics argues, “There’s this notion that somehow we could give you a genetic test and find out your risk factors and control them or monitor them, that’s science that isn’t here yet.”
Status of the Unregulated Market
The many inaccuracies of identifying genetics adds to how potentially harmful these seemly innocent tests can be. A recent study showed that when given a gene, various labs report different answers when identifying the same gene variant over 20% of the time. While the FDA proposed regulatory guidelines in 2015 highlighting the possible dangers that can result from commercial genetic testing, the institution withdrew their proposed regulatory guidelines soon after. The current administration has yet to put any in place.
While many regulatory gaps still exist and the science continues to develop, the public must evaluate their individual options to see if genetic testing pros outweigh the cons.