By Sheldon Krimsky

The marketing of genetic tests to consumers is following a path similar to direct-to-consumer marketing of prescription drugs. And while there are good reasons for the Food and Drug Administration to rescind the rule on prescription drug advertising, there are greater risks to consumers in DTC marketing of genetic tests.

Here are some reasons. First, drug companies cannot advertise drugs that have not been approved by the FDA. Recently, it was reported that Allergan, the maker of Botox, agreed to pay $600 million to settle charges that it illegally advertised the drug for unapproved uses. Genetic tests, however, do not have to be federally approved or validated. The tests may or may not do what the companies claim they can do. Consumers have no recourse. 

Second, most physicians are not familiar with the validation criteria, sensitivity, or reliability of genetic tests. They depend upon the interpretation by the company. If people take prescription drugs—whether or not they are marketed DTC—which turn out either ineffective or produce an adverse effect, they can discuss it with their doctor. There are often substitutes that can be used, and adverse effects can be reported to the FDA and to the company.

Genetic tests, on the other hand, are often patented. There are rarely second opinions or the possibility of retests by another company. The test for the breast cancer mutations BRCA1 and BRCA2 was for years controlled by one company, Myriad Genetics. The successful initial lawsuit by the American Civil Liberties Union challenged the patent on BRCA, and the appeal will determine whether other companies can use the DNA sequences of BRCA mutations for their own tests.

Third, it is easy for DTC advertisers of genetic tests to overstate the significance of the test result, particularly those tests for which reliability has not been certified and standardization has not been set by a professional genetics association. Consumers of DTC genetic tests are on their own in what they purchase (caveat emptor) and what they read about the product claims (caveat lector). 

Fourth, in many cases DTC genetic tests create "needs" based on fears and false hopes. While a mutation may have some meaning in the context of a person's lifestyle, past history, or family health, the range of reliable interpretation and uncertainty associated with the consequences of having those mutations can be quite large. These tests circumvent genetic counselors who can advise people about whether they need such a test. Without the help of a trained genetic counselor, DTC genetic tests may induce severe psychological stress.

Finally, consumers cannot be certain about what happens to the information collected by genetic testing companies or whether that information can come back to haunt them. For example, if consumers who engage in DTC genetic testing are ever involved in litigation—say in a disability claim—they can be cross-examined about the test, however poor its reliability or the likelihood of it yielding a false positive result.


Sheldon Krimsky is Chair of the Board of Directors and a founder of the Council for Responsible Genetics. He is a Professor of Urban and Environmental Policy and Planning at Tufts University.

Search: GeneWatch
The Council for Responsible Genetics’ Genetic Privacy Manual: Understanding the Threats- Understanding Your Rights will be a comprehensive, electronic source of information for the consumer on these issues.
View Project
Genetic Testing, Privacy and Discrimination
View Project