Thursday, May 29, 2014

Don’t Do It, AMA

The American Medical Association (AMA) will soon be voting on a statement opposing the utilization of genetic testing services solely by providers who specialize in genetics (e.g. geneticists, genetic counselors) and in support of genetic testing by any provider regardless of specialty, education, or certification. The serious negative ethical, legal, financial and medical implications of this approach have been well documented (1-7). In addition, several of the statements in the proposal are inaccurate:

Proposed Statement: “Certified clinical genetic counselors and medical geneticists are in severe shortage in many areas of the country.”
Response: This is not accurate. There are many board certified geneticists practicing in the United States – many of whom have outreach clinics covering large geographic areas.  For patients without a local genetic counselor, access is no longer an issue because there are now internet, phone and satellite based telemedicine services available for genetic counseling (8,9).

Proposed Statement: “Physicians treating patients who may be suspected of genetic susceptibility to cancer are well educated as to the indications for and implications of such genetic testing.”
Response: Multiple studies spanning more than a decade have shown that the majority of physicians do not have the education, training or certification to take on this detailed and ever-evolving subspecialty (6,7,10-27).  Evidence continues to mount that the majority of physicians order either too much, or incorrect, testing in even straightforward cases (5-7). Serious, life-threatening errors have resulted from clinicians without proper training and credentials practicing generic counseling and testing (1-3).  Medical malpractice claims have been filed against such clinicians, and the number of lawsuits these clinicians will face is likely to inflate as genetic technology becomes increasingly complex (28). 

Proposed Statement: “The requirement for an independent specialist may interfere with the timing and coordination of care.”
Response: Genetic counseling centers routinely reserve appointments for urgent patients for surgical or radiation decision-making immediately, without delaying such treatment.   High standards for thorough genetic counseling, informed consent, proper ordering and accurate result interpretation will be paramount in harnessing the benefits of genetic testing and correctly incorporating this information into a patient’s medical management. 

Proposed Statement: “The ultimate decision on the medical necessity for genetic testing should be within the realm of the treating physician and his or her patient.”
Response: With an average of 20-22 minutes scheduled per patient (29), it is both unrealistic and unfair to expect the already overburdened clinician to take on the complex role of cancer genetic counseling and testing.  A more efficient approach is for the clinician to choose which patients need genetic counseling and to refer them to a certified genetic counselor. In addition, patients do not expect their clinicians to be experts in genetics, but to play a key role in referring them for these genetic services (30). 

We ask the AMA to consider these facts when voting on this upcoming proposal,that places both physicians and patients at risk.


1.  Brierley, KL, et al (2012). Cancer Journal, 18:303-309.
2.  Brierley, KL, et al. (2010). Connecticut Medicine, 74(7):413-423.
3.  Bensend TA, et al (2014) Journal of Genetic Counseling. 23(1):48-63.
4.  UnitedHealth (2012) working paper 7.  UnitedHealth Center for Health Reform and Modernization.
5.  Value of Genetic Counselors in the Laboratory (2011). Lab Document. ARUP
6.  Plon SE, et al. (2011) Genet Med. 13(2):148-154.
7.  Bellcross C, et al. (2011) American Journal of Preventive Medicine, 40(1):61-66.
8.  Hilgart, J et al. (2012) Gen in Med:14(9):765–776.
10. Emery J, et al. (1999). Fam Pract, 16:426-445.
11. Wilkins-Haug L, et al. (2000). Obstet Gynecol, 95:421-424.
12. Wilkins-Haug L, et al(1999). J Genet Couns, 8:301-311.
13. Suchard MA, (1999). J Genet Couns, 8:301-311.
14. Watson EK et al. (1999). Fam Pract, 16:420-425.
15. Fry A, et al. (1999).  Fam Pract, 16:486-474.
16. Suther S and Goodson P. (2003). Genetics in Medicine, 5(2):70-76.
17. Wideroff L et al. (2003) Cancer Epidemiology, Biomarkers, and Prevention, 12:295-303.
18. Burke W et al. (2009). American Journal of Medical Genetics, 149A: 349-356.
19. Brandt R et al. (2008). Genetic Testing, 12(1): 9-12.
20. Wood ME, et al. (2008). Family Practice, 25:334-340.
21. Chorley W and MacDermot K. (1997). BMJ, 314(7078):441.
22. Demmer LA et al (2000). JAMA, 284:2595-2596.
23. Giardiello FM et al. (1997). The New England Journal of Medicine, 336(12):823-827.
24. Wilkins-Haug L, et al. (2000). Obstet Gynecol, 95:421-424.
25. Greendale K and Pyeritz RE. (2001). Am J Med Genet, 106:223-232.
26. Baars MJ, et al. (2005) Genetics in Medicine,  7(9):605-610.
27. Wideroff, L., et al.   (2005). Journal of Medical Genetics, 42(10):749-755.
28. Lindor RA and Marchant GE. (2011) ASCO Annual Meeting; Chicago, Illinois. Abstract #6073.
29. Weeks WB, Wallace AE. (2003) Arch Intern Med. 163(8):944-8.
30.  Miller FA,  et al. (2010) Family Practice, 27:563–569