The purpose of this exercise is to get you to think about the ethical issues involved in "direct to consumer genetics," that is, people paying for their own genotyping. There are dozens of companies that offer such services, and for concreteness we will use one of the better known, 23andMe, in our example.
23andMe offers screening for nearly 90 genetic markers related to health and disease. New markers are added regularly, as the science progresses. The company suggests that there are risks that should be considered in using their services.
In this exercise, we are going to pretend that a new marker for Alzheimer's disease has been discovered, that the company added it to its list of preliminary research findings, and that one of their clients discovered s/he has the risk allele.
Each student will be assigned to a potentially relevant role:
- A scientist who discovered the genetic marker, and who is aware of the uncertainties around such markers.
- A client, who found out that s/he has the risk allele, and now regrets giving consent for tests that weren't on the original list of markers.
- A representative of the 23andMe company, trying to make the business work.
- The client's spouse (or adult child).
- The client's physician, who doesn't have direct access to this result.
- An insurance company representative; the client has applied to buy a large disability insurance policy.
- The client's employer, who is considering putting the client in charge of an important long term project, and has asked if there is any reason that shouldn't happen.
- A hacker who has broken into the 23andMe database, and is trying to take advantage of the ill-gotten access.
- A prosecutor looking to enforce the Genetic Information Non-discrimination Act
We will use this exercise to look at several interesting issues in direct to consumer genetics from multiple viewpoints:
- What are the risks to the subject and others of genetic tests marketed directly to consumers?
- What is the responsibility of the discoverer to the people and institutions that might be affected by the discovery?
- Who is entitled to know or act on the information about a genetic marker?
- When is consent for genetic testing given, and under what circumstances can that consent be retracted?
- What is the proper role of profit and markets in genetics?
- How does direct to consumer genetics interact with clinical care?
- What is the proper government role?
Here is some useful background information:
- A recent review of the genetics of Alzheimer's Disease.
- The National Library of Medicine's Genetics Home Reference on direct to consumer genetic testing.
- A personal narrative about the 23 and me service in the New York Times.
- There is (sort of) a genetic test for Alzheimer's that just came to market. It's the only genetic information that James Watson kept secret when his genome was sequenced.
- Federal Trade Commission advice on direct to consumer genetics.
- The American Society of Human Genetics statement on direct to consumer testing in the US.
- A Centers for Disease Control survey of consumers and providers of direct to consumer genetic testing.
- Two articles from the June issue of he American Journal of Bioethics on the topic, Ask Your Doctor If This Genetic Test is Right For You, and Direct to Confusion.
- Summary of an NIH workshop on direct to consumer genetic tests.
- A legal analysis of regulating direct to consumer genetic tests.
- The American Medical Association's new position opposing direct to consumer genetic testing (text) and a recent editorial
- A news story about the California legal issues direct to consumer genetics companies had.
- A concern that accurate genetic tests combined with GINA-like non-discrimination requirements will lead to the downfall of the private health insurance industry.
- The modest amount of financial information available about 23 and Me, which is a privately held company. Here's a news story with a little more information. Note that bioinformaticians Russ Altman, Serafim Batzoglou, and Daphne Koller are on the scientific advisory board.
