Wednesday, September 11, 2013

Has Myriad Learned Their Lesson?

Several papers have demonstrated that most physicians do not have the time or knowledge to offer their own genetic counseling to patients. There are documented cases of patients being harmed by these practices (1,2) and physicians who have subsequently been sued for mismanaging these patients (3). Over the past 15 years, Myriad Genetics has directly targeted clinicians with little to no background in genetics and encouraged them to offer their own genetic testing, without counseling by a trained and certified professional (1,2,4). Myriad has been widely criticized for this and other practices that have contributed to adverse events for patients and lawsuits for clinicians. Has Myriad learned their lesson? Or do they continue to put both clinicians and patients at risk? The evidence below suggests the latter.

1. PracticeAdvisor
Myriad recently released PracticeAdvisor, an e-learning program aimed at training general physicians and their staff on how to "implement a simple and effective hereditary cancer risk assessment protocol… to achieve the cancer risk assessment standard of care". Myriad’s PracticeAdvisor attempts to convey that genetic testing is a simple and straightforward process and fails to capture several key aspects of the genetic counseling process, contributing to the belief that anybody can order a “simple” genetic test and provide the patient with a “simple” answer.

2. Targeting Mammography Technicians
Recent emails circulating in the field indicate that Myriad plans to target mammography technicians as appropriate providers to order BRCA1/2 testing. These technicians likely have even less training in genetics than the physicians and nurses Myriad has targeted in the past. This is once again dangerous both for patients, who risk undergoing unnecessary surveillance and surgery or having false reassurance that their cancer risk is not elevated, as well as mammography technicians who could face legal action if the testing, results and/or management are not handled correctly.

3. Panel Testing
Myriad is now offering ‘panel’ testing that includes many genes as part of a single test, including several rare genes (5). If mistakes were made when Myriad was offering genetic testing for BRCA1 and BRCA2 alone, imagine what will happen when physicians and/or mammo techs begin to order and interpret these complex panels. The genes included in Myriad’s panel testing may not have a clear course of action and could present a challenge for even the most seasoned genetics expert.

4. Patent Debate
Now that the SCOTUS has made it illegal to hold a patent on human genes, the market has burst wide open to allow companies other than Myriad Genetics to offer more comprehensive testing for BRCA1/2 at more affordable prices. While this is in the best interest of the patient and will allow greater access to care for a larger number of patients, Myriad has been suing these companies (6) in what appears to be an attempt to bully them into backing down from offering the test and/or drain their financial resources.

Some studies have shown that up to 30-40% of genetic tests are being ordered in error and are costing insurers millions in unnecessary healthcare dollars (7). To avoid such gross losses, some insurance providers are now joining in the fight to shift away from the practice of non-genetics specialists ordering genetic tests. For example, Cigna has just developed a Genetic Testing and Counseling Program that will require its customers to undergo genetic counseling by a certified genetic counselor or medical geneticist prior to having genetic testing (8). This program was developed in direct response to the high cost and adverse outcomes associated with genetic testing by non-genetics specialists.

So, has Myriad learned their lesson? It appears that the answer is no, and they continue to encourage non-genetics specialists to take on the increasingly challenging role of ordering and interpreting genetic tests, at the risk of both the patients and the well-meaning clinicians they recruit.

Niki Lovick, MS & Michelle Ernst, MS

1. Brierley, K.L., Blouch, E., Cogswell, W., Homer, J.P., Pencarinha, D., Stanislaw, C.L., Matloff, E.T. (2012). Adverse Events in Cancer Genetic Testing: Medical, Ethical, Legal, and Financial Implications. Cancer Journal, 18:303-309.

2. Brierley, K.L., Campfield, D., Ducaine, W., Dohany, L., Donenberg, T., Shannon, K., Schwartz, R., Matloff, E.T. (2010). Errors in delivery of cancer genetics services: implications for practice. Connecticut Medicine, 74(7):413-423.

3. Lindor. R.A.,Marchant, G.E., O’Connor, S.D. (2011). A review of medical malpractice claims related to clinical genetic testing. Journal of Clinical Oncology, 29(15_suppl): abstract 6073.

4. Matloff, E.T., Caplan, A. (2008).Direct to Confusion: Lessors Learned from Marketing BRCA Testing. The American Journal of Bioethics, 8(6):5-8.

5. Myriad Genetics. “Myriad Genetics Launches myRisk ™ Hereditary Cancer Panel.” Myriad Press Release. 5 Sep. 2013. Web. 6 Sep. 2013. <>

6. Noonan, K.E. “Myriad Genetics Files Law Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes.” Patent Docs. 9 Jul. 2013. Web. 6. Sep. 2013. <>

7. White-paper-1-value-of-GCs-in-lab.pdf">Miller, C.E., Krautscheid, P., Baldwin, E.E., LaGrave, D., Openshaw, A., Hart, K., Tvrdik, T. “Value of Genetic Counselors in the Laboratory.” ARUP Laboratories. Mar. 2011. Web. 3 Sep. 2013. <>

8. National Society of Genetic Counselors. “Genetic Counseling Program Gives Cigna Customers Increased Access to Genetic Counselors.” NSGC. 23 Jul. 2013. Web. 30 Aug. 2013. <>