Commercial genetic testing companies are aggressively targeting doctor’s offices and encouraging them to order testing without counseling from a genetics expert. The testing companies argue that their sales forces are “providing doctors with the tools they need to do counseling in-house”(1). However, few doctors have extensive training in genetics, and are thus limited in their ability to interpret complex test results. Few clinicians have the infrastructure in their office to provide long-term follow-up for patients who carry a mutation, coordination of testing for family members, and methods of re-contacting patients when new laboratory techniques and additional testing become available. In addition, the testing companies are not educating doctors about other hereditary cancer syndromes and other genetic tests that may be offered by other testing companies, and, therefore, may be providing unbalanced and biased information to physicians.
Testing companies are also claiming that there are too few genetic counselors to provide genetic counseling services; thus, doctors should provide this service directly to their patients. They also argue that referring to an outside genetic counseling center delays testing and cancer treatment. However, there are many genetic counselors in the Northeast, including Connecticut, and accommodations are made for urgent cases so as to prevent delay in treatment. There are also options for accessing genetic counseling by certified providers through phone- and/or internet-based telemedicine services.
These marketing tools have lead to an increasing number of claims nationwide that patients are receiving “either too little or the wrong information about their genetic risk of developing cancer from companies marketing the tests” says, Sue Friedman, director of Facing Our Risk of Cancer Empowered (FORCE)(2). This has also led, in some cases, to unnecessary surgery, anxiety, and misuse of insurance money (Yale Cancer Genetic Counseling, unpublished data).
It is recommended that anyone having an adverse effect as a result of marketing genetic testing to physicians report it to the FDA(3). To do so, please go to https://www.accessdata.fda.gov/scripts/medwatch/ and complete the FDA MedWatch online voluntary reporting form. If you would like to report an adverse event but remain anonymous, please contact FORCE (http://www.facingourrisk.org). If you have questions about what to report or how to fill out the form, please contact Sharon Kapsch (sharon.kapsch@fda.hhs.gov) at the FDA Center for Devices and Radiological Health.
We recommend that all patients considering genetic testing be offered genetic counseling by a genetics expert prior to having their blood drawn for testing. To find a cancer genetic counselor in your area go to www.nsgc.org.
References:
1. Myriad Avoids Genetic Counseling ‘Bottleneck” for BRCA Testing By Helping Docs Do It Themselves. Pharmacogenomics Reporter, September 23, 2009.
2. More Patients Experience Inadequate Genetic Testing, Advocacy Official Says. Pharmacogenomics Reporter, January 14, 2009.
3. Patient Group Urges HHS Panel to Push for Oversight of DX Firm’s Genetic Test Marketing Practices. Pharmacogenomics Reporter, October 13, 2009.
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