HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, January 21, 2008

Regulating Genetic Tests or Not

The New York Times reported last week on a federal panel, Secretary’s Advisory Committee on Genetics, Health and Society, which submitted a report demonstrating its concerns over the increasing use of genetic tests without the appropriate regulation and oversight.  The Times article states,

The science of genetic tests is marching ahead and so are efforts to sell them directly to consumers who are willing to send in a check and a bit of saliva to learn whether they are at risk for a disease.  What is not keeping up is regulation and oversight, according to a federal advisory panel. The panel concluded that a growing number of the tests are being marketed with claims that are unproved, ambiguous, false or misleading.


Millions of people have already taken the tests, a relatively new tool that even many doctors have yet to master. Test results can provide information to help prevent, detect and treat hundreds of conditions including cancer, heart disease, diabetes, cystic fibrosis and blood disorders.  The results can lead to momentous decisions. For example, women with a family history of breast cancer rely on them in deciding whether to have surgery to remove breasts or ovaries as a preventive measure.

With use of the tests growing at an explosive rate, the panel concluded that patients could be harmed. In most cases, the tests do not pose a direct physical risk; but, the panel said, if a test is inaccurate, patients may be given risky, unnecessary treatments or denied treatments that would be highly beneficial.   In addition, the panel said, most doctors lack the training and expertise needed to interpret genetic tests, and many are unfamiliar with professional guidelines for their use. Although professional societies play an important role in making sure their members get up-to-date information, the panel said, “they cannot keep up with the pace of development of genetic tests.”

The panel went on to discuss some of the regulatory morass that is supposed to helping approve and oversee these genetic tests.  It doesn't make one feel overly comfortable.

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