Survey: Genetic Counseling Leads Some Patients to Cheaper BRCA Tests

Excerpt from GenomeWeb:

When patients seeking BRCA testing are counseled by certified genetic healthcare providers (GHP) they may be more likely to receive cheaper testing procedures, thereby avoiding expensive comprehensive sequencing tests, according to a new study.

The research, conducted by investigators at the Moffitt Cancer Center and published yesterday in Genetics in Medicine, found that patients seeking to find out their BRCA1 and BRCA2 status who met with GHPs, or genetic counselors and geneticists, also were more likely to recall having pre-test counseling that fit into nationally recommended guidelines.

"Our results suggest that genetic healthcare providers are less likely to order more expensive comprehensive genetic testing, when less expensive testing may be appropriate," lead study author Deborah Cragun, a post-doctoral fellow at Moffitt, said in a statement.

To read the full article please visit: http://www.genomeweb.com//clinical-genomics/survey-genetic-counseling-leads-some-patients-cheaper-brca-tests Read more!

The Truth about Public Genetic Databases

The vast majority (95%) of individuals pursuing BRCA testing receive one of two types of results: 1) negative results with no mutation or variant found or 2) a BRCA mutation detected. Both should be interpreted carefully by a certified genetic counselor in the context of that patient’s personal/family history.

However ~3-5% of individuals pursuing BRCA testing will learn that they carry a BRCA “variant of uncertain significance” or VUS, whose significance is not yet known. One commercial testing laboratory, that recently lost its patents on the BRCA1 and BRCA2 genes, has found new ways to leverage its product, including describing its variant classification and private database as “vastly superior” and a major differentiator among its competitors (1). Their newest claims call public databases into question (2). Upon recent return to their website, they have taken this page and video down. However, we aim to clarify this discussion.

This commercial laboratory has raised concerns about the “quality control” and “oversight” of public databases and the “safety and well-being of patients.”

This laboratory claims that its contributions to public databases stopped due to concerns over database curation, matching data formats and patient safety. However, several reports have emerged that this change in philosophy had more to do with hoarding trade secrets than patient care (3,4). Recently, executives at this laboratory acknowledged that their “competitors reliance on public databases with high VUS and error rates will further restrict patient access to life-saving medicine (5).” This statement was made in the context of PARP inhibitor eligibility.

Other laboratories, clinicians, scientist and patients have recognized that patients, clinicians and researchers will benefit from pooling of such mutation and variant data and have created or contributed to the Free the Data movement (http://www.free-the-data.org). With recognition of the greater good created from shared information, some patients have begun to request that their testing be performed only at a laboratory that shares their data. Data-sharing has become a selling point for laboratories competing for BRCA testing. As this movement gains greater attention and traction, creating public genetic databases that feature proper curation of data, transparency on how variant classification decisions are made, and open forums for discussion will be critical. Read more on this topic here: Choosing a BRCA Genetic Testing Laboratory: A Patient-Centric and Ethical Call to Action for Clinicians and Payer.

This lab also reports that they plan to publish a comparison showing wide disparities of over 2,000 variants in BRCA1 and BRCA2 among 5 public databases with their proprietary database. We look forward to an open discussion of their data but realize that this will likely be a one-sided conversation as it has been for many years. The few recent publications from this laboratory lack analytic algorithms and underlying sequence details that are necessary to validate and interpret their data independently (6–10). This is in contrast with national recommendations to include such data for validation (11, 12). For many years, this laboratory has had access to public databases and researchers work while not contributing anything themselves nor allowing access to their internal data. This relationship has created an inequity that relates to basic scientific and medical information. Cook-Deegan and colleagues concluded that this dynamic “changes the policy context, prompting a debate about keeping clinically relevant data proprietary when that secrecy makes independent verification of its medical significance impossible (3).”

In addition, ethical questions have been raised regarding this labs refusal to disclose mutation/variant classification information on genes that were initially discovered as a result of a large, international research collaboration, funded by government grants and then kept under lock-and-key by patents that have now been invalidated (1, 13-16).

It appears that the ultimate goal of retaining such data as a trade secret is to extend the life of their patents and continue to reap the financial windfall from their long held monopoly.

For more on this topic visit: http://www.ajmc.com/publications/evidence-based-oncology/2014/May-2014/Choosing-a-BRCA-Genetic-Testing-Laboratory-A-Patient-Centric-and-Ethical-Call-to-Action-for-Clinicians-and-Payers

References:
1. Pollack A. Despite gene patent victory, Myriad Genetics faces challenges. The New York Times. http://www.nytimes.com/2011/08/25/business/despite-gene-patent-victory-myriad-genetics-faces-challenges.html?pagewanted=all&module=Search&mabReward=relbias%3Ar Published August 24, 2011.

2. Myriad Pro “Public Variant Database Considerations” https://myriadpro.com/public-variant-database-considerations/?utm_source=hs_email&utm_medium=email&utm_content=13160318&_hsenc=p2ANqtz-9Hy2EyKDKSdFjrPHm_KZ_dJNRO5NUp-qg34AZtg2pobHjD5YCI0hHXqRurLUdsv0yUXd_UmiBS2e6V0NMzflCT8ptK3ds1rKIZcCTTQmTGYQpyWPI&_hsmi=13160318 Accessed June 13, 2014

3. Cook-Deegan R, Conley JM, Evans JP, Vorhaus D. The next controversy in genetic testing: clinical data as trade secrets. Eur J Hum Genet. 2013;21:585-588.

4. Ray T. In tackling the VUS challenge, are public databases the solution or a liability for labs? Pharmacogenomics Reporter. http://www.genomeweb.com/clinical-genomics/tackling-vuschallenge-are-public-databases-solution-or-liabilitylabs. Published February 12, 2014. Accessed February 27, 2014.

5. Seeking Alpha. Myriad Genetics’ (MYGN) CEO Peter Meldrum on Q3 2014 Results - Earnings Call Transcript. http://seekingalpha.com/article/2196503-myriad-genetics-mygn-ceopeter-meldrum-on-q3-2014-results-earningscall-transcript?page=3. Published May 6, 2014. Accessed May 7, 2014.

6. Easton DF, Deffenbaugh AM, Pruss D et al: A systematic genetic assessment of 1,433 sequence variants of unknown clinical significance in the BRCA1 and BRCA2 breast cancer-predisposition genes. Am J Hum Genet 2007; 81: 873–883.

7. Eisenbraun A, Wenstrup R, Hellerstedt B et al: Hereditary breast and ovarian cancer testing: integration and outcomes within community oncology practices. Commun Oncol 2010; 7: 75–81.

8. Hall MJ, Reid JE, Burbidge LA et al: BRCA1 and BRCA2 mutations in women of different ethnicities undergoing testing for hereditary breast-ovarian cancer. Cancer 2009; 115: 2222–2233.

9. Saam JBL, Bowles K, Roa B et al: Decline in rate of BRCA1/2 variants of uncertain significance: 2002-2008. 27th Annual Education Conference of the National Society of Genetic Counselors. Los Angeles, CA 2008.

10. Wu K, Hinson SR, Ohashi A et al: Functional evaluation and cancer risk assessment of BRCA2 unclassified variants. Cancer Res 2005; 65: 417–426.

11. Micheel CM, Nass SJ, Omenn GS (eds Evolution of Translational Omics: Lessons Learned and the Path Forward. National Academies Press, 2012.

12. National Research Council: Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences. Washington, DC: National Academies Press, 2003.

13. Matloff E1, Caplan A. Direct to confusion: lessons learned from marketing BRCA testing. Am J Bioeth. 2008;8(6):5-8.

14. Williams-Jones, B. 2006. Be ready against cancer, now: direct-to-consumer advertising for genetic testing. New Genetics and Society, 25(1): 89–107.

15. Hall, J., Lee, M., Newman, B., Morrow, J. E., Anderson, L. A. and Huey, B. 1990. Linkage of early-onset familial breast cancer to chromosome 17q21. Science, 250(4988): 1684–1689.

16. Wooster, R., Neuhausen, S., Mangion, J., Quirk, Y., Ford, D. and Collins, N. 1994. Localization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12-13. Science, 265(5181): 2088–2090.

Read more!

Don’t Deny our Active Military Life-Saving Genetic Services

TRICARE, the insurance carrier of our active military and their families, ceased to cover more than 100 laboratory-based tests last year, including genetic tests for most hereditary cancer syndromes (excluding BRCA). This decision places TRICARE out-of-step with other government programs and commercial health insurance. Genetic Alliance is asking organizations to join in support to petition members of the House and Senate Armed Services Committees to restore coverage for these important, life-saving tests.

To show your support, go to http://www.geneticalliance.org/tricare-sign to sign their letter by Sunday, June 15.
Read more!

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.

References:

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.

9.  Taylor A. (2012) The Advisory Board Company: Oncology Roundtable. Accessed at: http://www.advisory.com/research/oncology-roundtable/oncology-rounds/2012/05/outsourcing-genetic-counseling-to-meet-2012-coc-standards

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, et.al (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

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Article Concluding the Majority of Breast Surgeons Provide Adequate Genetic Counseling Demonstrates the Opposite

An original article published online in the Annals of Surgical Oncology (Ann Surg Oncol DOI 10.1245/s10434-014-3711-9) is noteworthy for many reasons.

• This article is entitled, ‘Can Breast Surgeons Provide Breast Cancer Genetic Testing?’, and yet the methods used cannot adequately answer this question. The authors surveyed breast surgeons requesting a ‘self-assessment of skills and experience’. This methodology is flawed, to say the least, and it is difficult to believe that such an article would be published in a peer-reviewed journal in 2014.

• Fewer than 35% of those surveyed responded, with a possible selection bias toward those surgeons most interested and educated in genetic testing. And yet only half (51.6%) report that they both feel confident in their ability to provide appropriate pre- and post-BRCA test counseling and do so as a standard practice.

• Only 63% of respondents standardly obtain a 3-generation pedigree for their patient’s family history of cancer, a requirement by NCCN Guidelines as part of the breast and/or ovarian cancer risk assessment.1 This omission of a critical element of genetic counseling makes it impossible for the clinician to perform a risk assessment, order the correct genetic test, and could result in patients being denied coverage for testing.1 Such errors have been shown to result in patients having inappropriate prophylactic surgeries, inappropriate surveillance and even increased mortality, nationally.2,3,4

• This study includes no measures of knowledge, training, or education of the respondents. There is a vast body of literature showing that physicians do not have the time, education or knowledge to provide these services.5-22

• The authors conclude from their findings that “the majority of breast surgeons report appropriate practices related to assessing genetic risk, obtaining testing, interpreting the results, and providing counseling and related clinical services.” However, this study actually does not provide any data regarding how often breast surgeons interpret test results accurately, make appropriate screening and risk reduction recommendations based on test results, or provide “related clinical services”.

• Disturbingly, the authors declare no conflict of interest. Yet, at least one of the authors has worked as a speaker for Myriad Genetics Laboratory in 2014. Such conflicts of interest in choosing laboratories and influencing policy has been a subject of recent debate.23


1. NCCN Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 1.2014. www.nccn.org. Accessed May 23, 2014.

2. Brierley KL, Campfield D, Ducaine W, et al. Errors in delivery of cancer genetics services: implications for practice. Connecticut Medicine. 2010;74:413-423.

3. Brierley KL,Blouch E, Cogswell W, et al. Adverse events in cancer genetic testing: medical, ethical, legal, and financial implications. The Cancer Journal. 2012;18(4):303-309.

4. Bensend TA, Veach PM, Niendorf KB. What's the Harm? Genetic Counselor Perceptions of Adverse Effects of Genetics Service Provision by Non-Genetics Professionals. Journal of Genetic Counseling. Feb 2014;23(1):48-63.

5. Emery J, Watson E, Rose P, Andermann A. A systematic review of the literature exploring the role of primary care in genetic services. Fam Pract 1999; 16:426-445.

6. Greendale K and Pyeritz RE. Empowering primary care health professionals in medical genetics: How soon? How fast? How far? Am J Med Genet 2001;106:223-232.

7. Wilkins-Haug L, Hill L, et al. Gynecologists’ training, knowledge, and experiences in genetics: A survey. Obstet Gynecol 2000;95:421-424.

8. Wilkins-Haug L, Erickson K, et al. Obstetrician-Gynecologists’ opinions and attitudes on the role of Suchard MA, Yudkin P, Sinsheimer JS. Are general practitioners willing and able to provide genetic services for common diseases? J Genet Couns 1999;8:301-311.

9. Suchard MA, Yudkin P, Sinsheimer JS. Are general practitioners willing and able to provide genetic services for common diseases? J Genet Couns 1999;8:301-311.

10. Watson EK et al. The ‘new genetics’ and primary care: GP’s views on their role and their educational needs. Fam Pract 1999;16:420-425.

11. Fry A, Campbell H, Gudmundsdottir H, Rush R, Porteous M, Gorman D, Cull A. GP’s views on their role in cancer genetic counseling services and current practice. Fam Pract 1999; 16:486-474.

12. Suther S and Goodson P. Barriers to the provision of genetic services by primary care physicians: A systematic review of the literature. Genetics in Medicine 2003; 5(2):70-76.

13. Wilkins-Haug L, Erickson K, et al. Obstetrician-Gynecologists’ opinions and attitudes on the role of genetics in women’s health. J Womens Health Gend Based Med 2000;9:873-979.

14. Wideroff L et al. Physician use of genetic testing for cancer susceptibility: Results of a national survey. Cancer Epidemiology, Biomarkers, and Prevention 2003; 12:295-303.

15. Burke W et al. Genetic assessment of breast cancer risk in primary care practice. American Journal of Medical Genetics Part A 2009; 149A: 349-356.

16. Brandt R et al. Cancer genetics evaluation: Barriers to and improvements for referral. Genetic Testing 2008; 12(1): 9-12.

17. Wood ME, Stockdale A, and Flynn BS. Interviews with primary care physicians regarding taking and interpreting the cancer family history. Family Practice 2008; 25:334-340.

18. Chorley W and MacDermot K. Who should talk to patients with cancer about genetics? BMJ 1997; 314(7078):441.

19. Demmer LA et al. Knowledge of ethical standards in genetic testing amoung medical students, residents, and practicing physicians. JAMA 2000; 284:2595-2596.

20. Giardiello FM et al. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. The New England Journal of Medicine 1997; 336(12):823-827.

21. Plon SE, Cooper HP, Parks B, et al. Genetic testing and cancer risk management recommendations by physicians for at-risk relatives. Genet Med. Feb 2011;13(2):148-154.

22. Bellcross C, Kolor K, Goddard K, et al. Awareness and utilization of BRCA1/2 testing among U.S. primary care physicians. American Journal of Preventive Medicine. Jan 2011;40(1):61-66.

23. Matloff ET, Barnett RE, Nussbaum R. Choosing a BRCA genetic testing laboratory: a patient-centric and ethical call to action for clinicians and payers. American Journal of Managed Care. 2014;20 (Special Issue 7): SP229. Read more!

Geneticists on Both Coasts Issue “Call to Action” On Need to Share DNA Data

In the new issue of Evidence-Based Oncology, Ellen T. Matloff, MS, CGC, and Rachel E. Barnett, MS, CGC, of the Yale Cancer Center and Robert Nussbaum, MD, of UC San Francisco write that efforts by some genetic testing laboratories to grab market share in the lucrative BRCA testing market may put patients at risk, while violating ethical standards issued by the American Medical Association.

Geneticists from both coasts have issued a “call to action” over what they say are unethical actions by some genetic testing laboratories, which seek to gain or retain market share among patients trying to understand their cancer risk.

Ellen T. Matloff, MS, CGC, and Rachel E. Barnett, MS, CGC, of Yale Cancer Genetic Counseling at the Yale Cancer Center, and Robert Nussbaum, MD, of the University of California at San Francisco, are authors of a commentary appearing in the May-June 2014 issue of Evidence-Based Oncology, a news publication of The American Journal of Managed Care.

Their commentary, “Choosing a BRCA Genetic Testing Laboratory: A Patient-Centric and Ethical Call to Action for Clinicians and Payers,” decries what they say are efforts by some doctors to steer patients to laboratories, or even “demand” that tests by done by a certain lab. “In several instances it was discovered that these clinicians were either paid consultants for such laboratories, or received speaking fees or research funding from those entities,” the authors write.

This comes nearly a year after the U.S. Supreme Court, in a June 13, 2013, ruling, stripped away Myriad Genetics Inc.’s long-held patent protection for BRCA1 and BRCA2 testing. For years, Myriad held a monopoly on testing for patients’ risk of having breast or ovarian cancer, or, for men, of passing along those risks to daughters.

Matloff has said previously that the ruling, coupled with Angelina Jolie’s announcement that she had both breasts removed due to BRCA risk, caused interest in genetic testing to soar. The ruling set off competition in the genetic testing market, with a resulting drop in prices.

Since that time, however, the authors say that Myriad has moved to retain market share in two ways: first, the company continues its decade-long practice of not sharing patients’ DNA sequences with public research databases; and, second, company officials have made statements questioning the integrity of public databases, while telling investors that the quality of its privately held DNA data represents an edge over competitors.

The authors quote Myriad’s recent third-quarter investment call, which included the statement, regarding the cancer therapy PARP inhibitors, “Our competitors’ reliance on public databases with high VUS and error rates will further restrict patient access to this life-saving medicine.”

VUS, or variant of unknown significance, is a mutation in the BRCA1 or BRCA2 gene that may or may not result in cancer, and for which further study is needed. Mature data sets with more patients’ DNA sequences are less likely to report a VUS for which cancer risk has later been determined. However, the authors assert that Myriad is overstating its superiority. In reality, they write, Myriad’s reported 3% variant rate is only slightly lower than other labs – Ambry Genetics’ rate of 4.4% is cited – so the vast majority of patients would be unaffected.

Matloff told Evidence-Based Oncology that Myriad’s decision to withhold 11 years’ worth of BRCA testing data, a period in which it had market monopoly, means that patients who are tested elsewhere may not learn their true risk level, and could be denied life-saving cancer treatment as a result.

Matloff and her co-authors write that this decision runs afoul of an AMA resolution that considers unethical any decision to use “patents, trade secrets … or other means to limit the availability of medical procedures.”

The authors and others in the field have argued that withholding DNA data from public use is wrong for the following reasons:

-It puts patients at risk.
-It denies use of the data for public benefit, even though many tests that allowed the gathering of DNA were paid for by Medicare or Medicaid.
-It risks ongoing market concentration of certain genetic tests, which will keep prices high for patients, insurers, employers, and taxpayers. Conversely, the authors write, “sharing of genetic data will benefit patient care and clinical research, which may lead to lower healthcare costs for all.”

The authors write that broadening access to DNA data “is particularly relevant for publicly funded insurers that could create incentives or make data sharing a stipulation of coverage.”

The commentary appears in Evidence-Based Oncology with two related stories: a look at efforts to reform the reimbursement system for molecular diagnostic testing, which includes Myriad’s assertion of “rights” to intellectual property; and a portrait of GenBank, the public data-sharing initiative of the National Institutes of Health (NIH).

Click here to see the original press release on PRWeb

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Choosing a BRCA Genetic Testing Laboratory: A Patient-Centric and Ethical Call to Action for Clinicians and Payers

Genetic testing laboratories are using aggressive and manipulative tactics to capture market share in the BRCA testing market. Clinicians and payers are encouraged to utilize patient-centric criteria, including open access to data, to make decisions about genetic testing laboratories.

The past 12 months in the world of cancer genetic counseling have been more notable, perhaps, than the past 12 years combined. In May 2013, Hollywood icon Angelina Jolie went public with her BRCA1+ status, thrusting the field of cancer genetic testing and counseling into the spotlight and increasing referral rates to clinics by as much as 40% (E. T. Matloff, MS, oral communication, July 2013).1 One month later, the US Supreme Court unanimously ruled against the validity of patents that lay claim to genomic DNA in Association for Molecular Pathology v Myriad Genetics, Inc.2 Within hours, multiple laboratories began offering more comprehensive genetic testing for the hereditary breast and ovarian cancer genes BRCA1 and BRCA2, and at half the cost. The battle for the multi-million-dollar BRCA testing market had begun.

This battle has resulted in some genetic counseling centers reporting that referring clinicians have begun to request, or demand, that their patients’ BRCA testing be sent to a particular laboratory. In several instances it was discovered that these clinicians were either paid consultants for such laboratories, or received speaking fees or research funding from those entities.

This is clearly a conflict of interest in violation of a physician’s ethical obligations “to regard responsibility to the patient as paramount” and to discharge their “responsibility to participate in activities contributing to the improvement of the community and the betterment of public health.”3 Concerns about such manipulative tactics led us to develop a position statement stipulating that decisions about which genetic testing laboratories to use should focus on test quality, turnaround time, cost, and whether or not the laboratory shares its data in public databases (Table 1).

Without its patent-protected monopoly, Myriad now appears to be relying on trade secrets to maintain its share of the BRCA market.4,5 The “trade secrets” are actually a database of BRCA variants of uncertain significance (VUS) derived from the thousands of patient tests they have performed over the past decade.5 The company once contributed its data to a public database maintained by the National Institutes of Health, but ceased doing so in 2004.4 Several Myriad scientists and executives have stated that the public variant databases are not properly curated and that contributing to such resources would cause more harm than good; however, by at least 1 account, Myriad disclosed that it made its decision to stop sharing data for the purpose of retaining data as a trade secret.4,6



In Myriad’s Q3 Earnings Call Transcript of May 6, 2014, the company publicly acknowledged that in the context of PARP inhibitors, “Our competitors’ reliance on public databases with high VUS and error rates will further restrict patient access to this life-saving medicine.”7 The decision to hoard patient VUS data, even while recognizing that this decision will restrict patient access to lifesaving treatment, is incongruent with the American Medical Association’s (AMA’s) policy on Genome Analysis and Variant Identification (Table 2) and is considered unethical behavior according to the AMA’s Resolution E-9.095 on “the use of patents, trade secrets…or other means to limit the availability of medical procedures.”8,9

Although variant classification is important, few BRCA tests result in a variant of uncertain significance (ie, 4.4% at Ambry Genetics10). Myriad itself reports a 3% overall variant rate, slightly lower than other labs’ and presumably attributable to the superior testing experience enabled by its patents.11 Therefore, the vast majority of patients (~95%) are not impacted by a variant of uncertain significance, although the company describes its information as “vastly superior” and leverages variant classification ability as a major differentiator.5

Other laboratories offering BRCA testing have teamed with clinicians, scientists, and patients to expand the pool of publicly available genetic information for the betterment of clinical care and research as part of the Free the Data movement (http://www.free-the-data.org). This movement recognizes that patients, clinicians, scientists, and insurers could all benefit from pooling such information.

It has gained traction in patient communities, and some patients now request that their genetic testing be sent to laboratories that share data. Many of these competing laboratories are advertising their data-sharing policies as a way to gain market share. As this movement progresses, creating public genetic databases that feature proper curation of data, transparency on how variant classification decisions are made, and open forums for discussion will be critical.

With the growing number of laboratories offering testing, insurers are beginning to contract with particular laboratories for BRCA testing, designating certain laboratories as their in-network providers.12 Before negotiating such partnerships, payers and regulators have the opportunity to choose to partner only with high-quality laboratories that pledge to share all past, present, and future data in public databases.

As Cook-Deegan et al write, “National health systems and insurers, regulators, researchers, providers, and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing.”3 This is particularly relevant for publicly funded insurers that could create incentives or make data sharing a stipulation for coverage.4,13

Our patients deserve for decisions regarding where their genetic testing is performed to be unbiased, free of conflict, and based upon considerations unrelated to the clinician’s self-interest. Moreover, sharing of genetic data will benefit patient care and clinical research, which may lead to lower healthcare costs for all moving forward. The choice to use only laboratories that are committed to quality, efficiency, and facilitating progress for all through sharing of data represents an important opportunity as our healthcare system evolves.


Ellen T. Matloff and Rachel E. Barnett: Yale Cancer Genetic Counseling, Yale Cancer Center, Yale School of Medicine. Robert Nussbaum, MD: Division of Medical Genetics, University of California, San Francisco School of Medicine.
References

1. Jolie A. My medical choice. The New York Times. http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html/?_r=0. Published May 14, 2013.

2. Supreme Court of the United States. Association for Molecular Pathology v Myriad Genetics, 2013 WL 2631062 (June 13, 2013).

3. American Medical Association. Principles of medical ethics. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/codemedical-ethics/principles-medical-ethics.page. Accessed May 7, 2014.

4. Cook-Deegan R, Conley JM, Evans JP, Vorhaus D. The next controversy in genetic testing:clinical data as trade secrets. Eur J Hum Genet. 2013;21:585-588.

5. Pollack A. Despite gene patent victory, Myriad Genetics faces challenges. The New York Times. http://www.nytimes.com/2011/08/25/business/despite-gene-patent-victory-myriad-geneticsfaces-challenges.html?pagewanted=all&_r=0. Published August 24, 2011.

6. Ray T. In tackling the VUS challenge, are public databases the solution or a liability for labs? Pharmacogenomics Reporter. http://www.genomeweb.com/clinical-genomics/tackling-vuschallenge-are-public-databases-solution-or-liabilitylabs. Published February 12, 2014. Accessed February 27, 2014.

7. Seeking Alpha. Myriad Genetics’ (MYGN) CEO Peter Meldrum on Q3 2014 Results - Earnings Call Transcript. http://seekingalpha.com/article/2196503-myriad-genetics-mygn-ceopeter-meldrum-on-q3-2014-results-earningscall-transcript?page=3. Published May 6, 2014. Accessed May 7, 2014.

8. American Medical Association. D-460.971 Genome analysis and variant identification policy statement. www.ama-assn.org. Published June 2013. Accessed May 2, 2014.

9. American Medical Association. Amendment to Opinion E-9.095 Trademarks, patents, copyrights, and other legal restrictions on medical procedures.www.ama.assn.org. Published November 2007. Accessed May 6, 2014.

10. Ambry Genetics. BRCA 1/2 Test Information Fact Sheet. http://www.ambrygen.com/tests/brca1-and-brca2. Accessed May 6, 2014.

11. Eggington JM, Burbidge L, Copeland K, et al. Current variant of uncertain significance rates in BRCA1, BRCA2, and Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM) testing. Poster presented at the European Society of Human Genetics (ESHG) Congress 2012.

12. National Society of Genetic Counselors. Cancer Special Interest Group listserv postings. www.nsgc.org. May 2 and May 5, 2014.

13. News Briefs. Genetics in Medicine. 2014; 16(5):357-358.

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Genetic Testing Lab Position Statement

To show your support of this position statement, please send an e-mail with your intent, and affiliation to danielle.bonadies@yale.edu

Since the patents on the BRCA1 and BRCA2 genes (associated with hereditary breast and ovarian cancer) were overturned in mid-2013, the options for BRCA testing have exploded. Many laboratories are offering comprehensive, quality testing at ~50% of the previous cost. This competitive marketplace has many benefits to patients, providers and researchers, but we have also seen some laboratories beginning to use manipulative tactics to secure their profits in this volatile field. Genetic counseling centers have reported receiving pressure from clinicians to use specific laboratories for testing, learning that these clinicians are receiving financial incentives or hefty speaker's fees from these laboratories. The conflict of interest is clear. We have reports of other laboratories threatening to siphon-off referring clinicians if their laboratory isn’t used.

Below please find the full text on a “Genetic Testing Lab Position Statement” that pledges we, the ordering clinicians, will continue to make laboratory and testing choices based on what is in the best interest of our patients and will not be swayed by political, personal or financial gain.

This is also an opportune time for patient organizations, clinical organizations and insurers to show their support of laboratories that will fully share past, current and future data in open databases that serve research and patient care.

Please pass this on to your family, friends, colleagues, patients and contacts within your networks.

Genetic Testing Position Statement

Cancer Genetic Counseling Program Yale School of Medicine/Yale Cancer Center

New Haven, CT February 2014

With the emergence of new testing technologies and the 2013 Supreme Court decision banning gene patenting, the available cancer genetic testing options and the laboratories offering testing have expanded exponentially and are likely to continue to do so. As providers we have a responsibility to our patients to make the best decisions regarding which laboratory to use and which tests are most appropriate based on what is best for the patients. Our decisions will not be swayed by political, personal and/or financial gain.

Whenever possible (1), we will choose a laboratory based on these four criteria:

1. Quality: Is the test being offered accurate and comprehensive compared to what else is on the market?

2. Time: How long will the patient have to wait for his or her test results?

3. Cost: Will our patient’s insurance carrier cover this test at this laboratory?

4. Open Access: Has this facility pledged to Free The Data? Whenever possible we will choose laboratories that have pledged to make all of their past, present, and future gene data publicly available in order to allow this important information to be freely accessible to all clinicians and researchers, to further the advancement of medical knowledge and to best serve patient care. We will not support laboratories that hoard data.

To avoid any real or perceived conflicts of interest, we will not accept gifts (including trips, speaking stipends, stock options), funding, personal or financial support from testing laboratories. We pledge to update our laboratory choices over time as these choices evolve, choosing the best option for our patients and clinical research.

As clinicians, insurance plans, patient groups, and professional organizations nationwide begin to decide which laboratories to use in this quickly evolving marketplace, we ask that they join us in this pledge.

1. Laboratory choices must sometimes be based on insurance plan regulations, test availability, or the lab’s previous experience with a rare familial mutation.


 Genetic Testing Lab Position Statement.pdf -


Position Statement Signed By:


Clinicians:

Ellen T. Matloff, MS, CGC, Yale Cancer Genetic Counseling

Danielle C. Bonadies, MS, CGC Yale Cancer Genetic Counseling

Karina L. Brierley, MS, CGC, Yale Cancer Genetic Counseling

Rachel E. Barnett, MS CGC, Yale Cancer Genetic Counseling

Niki Lovick, MS CGC, Yale Cancer Genetic Counseling

Michelle Ernst, MS CGC, Yale Cancer Genetic Counseling

Jennifer Doherty, MS, CGC, Yale Cancer Genetic Counseling

Amanda Lamb, ScM, CGC, Maine Medical Center

Nisha Isaac, MS, CGC, University of Maryland St. Joseph Medical Center

Sayaka Hashimoto, MS, LGC, Nationwide Children's Hospital and Ohio State University

Kristin DePrince Mattie, MS, MD Anderson Cancer Center at Cooper

Cathleen McCann, MS, CGC, Sarasota Memorial Healthcare System

Paul B. Dorsey, MS, Legacy Genetic Services

Catie Beattie, MS, CGC, Casey Eye Institute

Peggy Cottrell, MS, CGC, Regional Cancer Center

Jessica Adsit, MS, CGC, Legacy Center for Maternal Fetal Medicine

Amie M. Blanco, MS, LCGC, UCSF Cancer Risk Program

Carrie Fagerstrom, MS, CGC, Randall Children's Hospital at Legacy Emanuel

Melanie Hardy, MS, CGC, Henrico Doctors’ Hospital

Allen E. Bale, MD, DNA Diagnostic Lab, Yale University

Robert Pilarski, MS, LGC; MSW, LSW, Ohio State University Cancer Genetics Program

Christina Dupre, MS, CGC, New England Ob/Gyn Associates

Lauren Ryan, MS, LCGC, UCSF Cancer Risk Program

Meagan Farmer, MS, CGC, University of Alabama at Birmingham

Robert Cook-Deegan, MD, Institute for Genome Sciences & Policy and Sanford School of Public Policy at Duke University

Carol Guthrie, MD Spokane Breast Center, Columbia Medical Associates

James P. Evans MD, PhD, Bryson Distinguished Professor of Genetics & Medicine, Editor-in-Chief; Genetics in Medicine, University of North Carolina at Chapel Hill

Robert Nussbaum, MD, Division of Medical Genetics, University of California, San Francisco

Erin Ash, MS, CGC, Bennett Cancer Center of Stamford Hospital

Cristina Ruiz, MS, CGC, Advocate Center for Breast Care,Oak Lawn, IL

Kelli Mayfarth, MS, CGC Health-Quest Hospital System, New York

Tricia Z. Page, MS, CGC, JScreen at Emory University

Kory Jasperson, MS CGC, Huntsman Cancer Institute

Cécile Skrzynia, MS, CGC,Cancer and Adult Genetic Counseling, UNC Chapel Hill

Kim Brussow, MS, LCGC,Good Samaritan Hospital

Jessica Chowns, MS, CGC, Parkview Health

Melissa Dempsey, MS,Parkview Health

Kathy Christiansen, RN, BSN, OCN,Cancer Prevention and Hereditary Cancer Risk Program, Methodist Estabrook Cancer Center

Marjan Champine, MS, LCGC, Huntsman Cancer Institute

Shawnia Ryan, MS, CGC, Providence Genetics Clinic

Lindsay Conant, MS, LCGC,Oregon Health Science University

Shelly Levin, MS, LCGC, Kaiser Permanente Medical Group

Amy K Krie,MD, Medical Oncologist, Clinical Director Avera Breast Program

Brittany Burnett, MS, LCGC, Sharp Healthcare, San Diego, CA


Community Members and Advocacy Groups:

Genetic Alliance

Kirsten Dooley, Yale Cancer Genetic Counseling

Lisa M Guzzardi, BRCA Advanced, Facebook Group

Marly Canuck Wietzke, Vancouver, BC, Canada

Nicki Boscia Durlester, Founder, Beyond the Pink Moon, Facebook Group

Pamela Morris Watt, CT

Tracy Dunbrook, CT

Cathy Corman, MA

Katie Behr, CT

Andrea Downing, Activist, Patient Advocate

Amy Byer Shainman, The BRCA Responder, BRCA Health Advocate, Co-Administrator of The BRCA Sisterhood on Facebook

Victoria Costello, Genetic Counseling Graduate Student, Sarah Lawrence

Leslie Kellman, NY

Marlene Kuma Gutierrez, CA

Rochelle Bernold, CT

Emily Kelley, Community Manager, Young Previvors Facebook Page

Teri Smieja, Co-author of Letters to Doctors, The BRCA/HBOC edition, Co-creator BRCA Sisterhood Facebook Group.

RaeAnn Kragenbring, Genetic Counseling Graduate Student, Sarah Lawrence

Mary Carpenter

Katherine Lambertson, Fellow, Genetic Alliance

Robin Baslaw, CT

Kate Berges, CT

Jessica DiGiovanna, Genetic Counselling Graduate Student, Mount Sinai

Peter Grudberg, CT

Terry Stoller, CT

Jill Holdren

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After 23andMe, Another Personal Genetics Firm Is Charged with False Advertising

Original post by Dina Fine Maron on Scientific American, 1/11/14

It sounded like a miracle of science and convenience: swab your cheek and drop the saliva sample in the mailbox and GeneLink Biosciences, a personal genetics company, would analyze your DNA and send back nutritional supplements customized to your personal genome. The regimen, the company promised, was good for diabetes, heart disease, arthritis, insomnia and other ailments. The Federal Trade Commission (FTC), however, thought it sounded like false advertising and brought a lawsuit against the company, charging its claims were misleading and not founded in sound science.

The case is the latest in the continuing controversy over personal DNA testing services. Two months ago the U.S. Food and Drug Administration warned 23andMe to stop selling its personal genetics testing kits because the company failed to prove its tests worked and the agency worried about the public health consequences of inaccurate results. The GeneLink case, the FTC’s first against a personal genomics company, could serve as a shot across the bow to other similar businesses. Under the terms of a proposed settlement announced on January 7, Orlando, Fla.–based GeneLink agreed to stop making unsubstantiated health claims. The settlement, which would only take place after a 30-day public comment period and a final decision from the FTC, would keep GeneLink and its former subsidiary, foru International, from making any future claims that their products can impact the course of disease unless such claims are supported by two double-blind, randomized control trials—the gold standard of medicine. A violation of that agreement could lead to fines.

“What we’re alleging is that [GeneLink’s] claims got ahead of the science,” says Carolyn Hann, a lead attorney on the case for the FTC’s Bureau of Consumer Protection. “By taking action against GeneLink and foru we were trying to indicate to this industry we were aware of the claims being made and we wanted the industry to understand where we stand on these issues,” she says. The FTC could not comment on whether other cases against genetic companies are in the offing. Although the commission opened investigations into two other genetic firms in the past, both cases were closed before action was taken, in part because the outfits were no longer going to market their products in the U.S.

GeneLink and its former subsidiary, now an independent company, had claimed that they were sending cheek swab samples to a third-party laboratory for analysis of genetic variations called single nucleotide polymorphisms (or SNPs). The companies claimed they could examine specific SNPs that affect nutritional health and aging and then offer personalized nutritional supplements and skin health products. “Any claims at all that one can look at those SNPs or other SNPs and make any meaningful recommendations for nutrition, cosmetics or anything along those lines are just entirely unfounded and entirely without any scientific merit,” says geneticist James Evans, editor in chief of the journal of the American College of Medical Genetics and Genomics.

The heart of the controversy was GeneLink’s claims that its custom-blended supplements could help compensate for aging or mitigate health issues such as heart disease and arthritis.

Under this lawsuit the FTC also charged that GeneLink failed to adequately protect consumer’s personal data, including contact information, Social Security and credit card numbers, and genetic data. According to FTC documents, GeneLink and foru had obtained genetic information from nearly 30,000 consumers since 2008. The proposed agreements would force the firms to set up comprehensive information security programs to protect such consumer data in the future and to assign at least one employee at each company to oversee that program. The corporations would also be required to receive initial regular external audits to check that the information is secure. The FTC cannot file criminal charges, only civil suits.

Click here to see the original post from Scientific American

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U.S. Preventive Services Task Force Finds Benefit in Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer for Small Group of High-Risk Women

WASHINGTON, D.C. – December 24, 2013 – The U.S. Preventive Services Task Force (Task Force) today published its final recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women. The Task Force recommends that women with family members who have had breast, ovarian, tubal, or peritoneal cancer talk with a health care professional to learn if their history might put them at risk for carrying a BRCA mutation. Women who screen positive should receive genetic counseling and, if indicated after counseling, BRCA testing. Additionally, for the vast majority of American women (90 percent), who do not have a family history associated with an increased risk for the inherited mutations, the Task Force continues to recommend against genetic counseling and testing.

One important step in preventing BRCA-related cancer is helping women understand their risk. Mutations in the BRCA1 and BRCA2 genes, which are present in 0.2 to 0.3 percent of women, are just one of many factors that can increase a woman’s risk for developing breast and ovarian cancer. Women with these potentially harmful mutations can have up to a five times greater chance of developing breast cancer, and BRCA mutations can also increase a woman’s lifetime risk for ovarian cancer to as high as 40 percent.

“Too many American women and families are faced with the challenge of dealing with cancer diagnosis and treatment. We have great hope in the science of genomics to improve screening practices and even prevent some cancers,” says Task Force chair Virginia Moyer, M.D., M.P.H. “At this point, the evidence shows that most American women will not benefit from genetic counseling or the test for gene mutations in BRCA1 and BRCA2. For women who have a family history that might be associated with an increased risk for these mutations, we found that some may benefit from in-depth genetic counseling that thoroughly reviews their family history and, if indicated and after weighing the pros and cons of BRCA testing, receiving the test.”

Current tests work best for women at a high risk for developing cancer, but the test alone does not always provide a definitive answer. There are some harms of testing; results are often inconclusive and many women could be burdened with the uncertainty of whether they are—or are not—at an increased risk for cancer. Inconclusive genetic testing leads many women to choose to take powerful medications or undergo major surgery to reduce their risk for developing cancer. Unfortunately, most will not benefit from these interventions and may needlessly suffer great harm, especially because they were never at increased risk to begin with. Therefore, the Task Force continues to recommend against routine genetic counseling and BRCA testing in women without a strong family history of cancer.

“Evidence still shows that there are serious, negative consequences that could result from testing women who are at low risk for BRCA mutations. The BRCA test works best for women who have reviewed their family history of breast or ovarian cancer and the pros and cons of the screening test with a trained professional,” says Dr. Moyer. “We hope further research will improve the ways genomic science can help women and their doctors understand their risk for cancer.”

The Task Force’s final recommendation statement is published online in Annals of Internal Medicine, as well as on the Task Force Web site at www.uspreventiveservicestaskforce.org. A fact sheet that explains the recommendation statement in plain language is also available. A draft version of this recommendation was available for public comment in April 2013.

The Task Force is an independent, volunteer panel of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications.

Contact: Ana Fullmer at Newsroom@USPSTF.net / (202) 350-6668

Click here to read the original bulletin by The U.S. Preventive Services Task Force
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CMS Cuts Reimbursement for BRCA1/2 Testing by 49 Percent; Analyst Downgrades Myriad Shares

Original post on GenomeWeb, 12/30/13

NEW YORK (GenomeWeb News) – The Centers for Medicare and Medicaid Services updated its reimbursement level for BRACA testing at $1,438 for 2014, a slash of nearly 49 percent from a previous level of $2,795.

As a result, investment bank Mizuho Securities today downgraded its rating on Myriad Genetics' shares to Hold from Buy and cut the price target on the company's stock to $24 from $36.

In morning trading on the Nasdaq on Monday, shares of Myriad fell 16 percent to $20.18.

In a document filed with the US Securities and Exchange Commission today, Myriad said CMS posted a National Limit Amount of $1,438.14 for CPT code 81211, which covers a test for the full sequencing of the BRCA1 and 2 genes, and for CPT code 81214, which covers a full sequencing of only the BRCA1 gene. No payment rate was set for CPT code 81216, which covers a test for the full sequencing of the BRCA2 gene.

The payment rates for 81211 and 81214 become effective "on or after" Jan. 1, 2014, CMS said.

CMS has opened a public comment period through Jan. 27, 2014, "[a]s the public has not had the opportunity to provide comment on the new NLA for 81211," Myriad said, adding it plans "to address a number of both substantive and process concerns" during the comment period.

"It is unclear why CMS has not valued the BRCA 2 gene in the 81211 code," the Salt Lake City-based company said. "It is also unclear how CMS arrived at the 81211 payment rate within the requirements of the federal gapfill regulations."

In September CMS posted an NLA for Myriad's BRACAnalysis test of $1,449 for the remainder of 2013, suggesting that that rate would last into 2014. Two Medicare contractors, however, quickly said that they had committed an error in setting the $1,449 figure.

In its new BRCA1/2 NLA document posted on Friday, CMS cited the decision by the US Supreme Court in June that invalidated certain claims on patents covering the BRCA1/2 genes held by Myriad. Before the SCOTUS decision, Myriad was the only laboratory offering BRCA testing, but since the judgment a number of firms, including Quest Diagnostics, Laboratory Corporation of America, and BioReference Laboratories' GeneDx business, have launched their own tests.

Medicare's Administrative Contractors (MAC) have received pricing data from the labs offering BRCA testing, and "[b]ased on the new information, the MACs submitted pricing information for CPT code 81211 that resulted in an NLA of $1,438.14," CMS said.

"At present, it is our understanding laboratories are offering the CPT code 81211 test for prices that range from approximately $900 to $2,900. As CPT code 81214 is similar to CPT code 81211, the additional comment period will apply to both CPT codes 81211 and 81214," CMS added.

Mizuho analyst Peter Lawson today downgraded Myriad's shares following the reimbursement cut, saying that although Medicare accounts for only 10 percent of Myriad's BRCA revenues, "CMS pricing has increased the fear that private payors may also cut pricing."

While the reimbursement rate may increase after the public comment period, "we are cautious on that outcome," Lawson said.

Leerink Swann analyst Dan Leonard added that even if BRCA testing reimbursement is increased, any increase will not take effect until after April 1, 2014. "[T]hus, the lower payment rate for 81211 will occur at least through" March 31, 2014, he said in a research note.

He maintained a Market Perform rating on Myriad's shares with a $25 price target.

Click here to see the original post on GenomeWeb

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Class Action Law Suit Filed Against 23andMe

Original post on Forbes by Dan Munro, 12/2/13

That didn’t take long. Quite literally about 5 days from the date of the FDA’s warning letter to 23andMe (11/22) and the filing of a class action law suit in the Southern District Court of California (11/27).

While the merits of the legal case are best suited for legal interpretation and debate, the damage to the marketing of general purpose Personal Genome Services (by 23andMe or any other company) could be significant. As stated in the filing:

“NATURE OF THE ACTION”

1. This proposed class action alleges that 23andMe, Inc. (“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS for its advertised uses.

2. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless.

3. Despite Defendant’s failure to receive marketing authorization or approval from the Food and Drug Administration (“FDA”), Defendant has slowly increased its list of indications for the PGS, and initiated new marketing campaigns, including television advertisements in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”).

It’s that second bullet point that’s at the very heart of the FDA filing and subsequent debate. Are the test results “meaningless?” Absent the scientific rigor of an FDA process – how do we as consumers know?

In light of all the recent publicity, several stories have also surfaced that call into question that exact point.

“The point is that if I cannot trust 23andMe to tell me much of value about my risk factor for Celiac, or my ability to digest dairy products or coffee, or to get my son’s results right, can I trust it for anything? What should I do if it tells me that I am at higher risk of developing Alzheimer’s or lung cancer? The answer is … not lose any sleep about it.” Bernard Munos – Forbes Contributor – 11/29/2013 (23andMe: A Fumbling Gene In It’s Corporate DNA)

“I sent a support request to 23andMe including my research and conclusions (this would be called a “bug report” in software engineering). After a few days of waiting, 23andMe confirmed the bug and apologized. So the bug was not inside of me, but in the algorithm. An algorithm can be fixed easily, unlike my genetic code.” Lukas F. Hartmann – 11/26/2013 (Why 23andMe Might Have The FDA Worried: It Wrongly Told Me I Might Die Young)

The controversy extends further back too. This was filed in April of 2011:

My suggestion is that unless you have a specific reason behind your motivation, don’t bother with genetic testing services, especially if you’re not of European ancestry and you’re under the age of 30. I can see how it may be useful as a preemptive measure for people with a family history of a debilitating disease, or for people who are seeking out long-lost relatives. But for the rest of us, the money is probably better spent towards a gym membership, more fruits and vegetables and health/life insurance. And not having to worry for the rest of your life about something that may or may not happen to you? That’s priceless. Elly Hart – Night Editor, Allure Media (Why 23andMe Genetic Testing Is A Waste of Time and Money)

Ms. Hart also points out a legal dilemma that has yet to be tested. The Genetic Information Nondiscrimination Act (GINA – 2008 here) specifically prohibits the use of genetic information in health insurance and employment. GINA has no such applicability to Disability or Life Insurance as noted by this repetitive 23andMe disclaimer: “GINA does not cover life or disability insurance providers” (8 occurrences here).

All of which is why the FDA was correct in issuing their warning. It’s one thing to believe in the false hopes and misleading promises of dietary supplements. It’s something else entirely when an email arrives warning you of a serious health condition or genetic risk lurking in your DNA. For anything beyond ancestral curiosity, personal genetic data definitely needs the full rigor of scientific review and accuracy.

Click here to see the original article on Forbes.com


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Ask Well: Genetic Testing for Breast Cancer

Original post by Roni Caryn Rabyn, NYTimes, 11/27/13

Some Israeli doctors want Israel to conduct a national screening campaign to test all Jewish Israeli women of Ashkenazi descent for harmful genetic mutations that heighten the risk of breast and ovarian cancer. The debate is detailed in the article, “In Israel, a Push to Screen for Cancer Gene Leaves Many Conflicted.”

Most American Jews are Ashkenazi, meaning their families originated in Eastern and Central Europe and they may be wondering if they should seek genetic testing.

Here are answers to some questions about genetic testing for the three common harmful mutations in the BRCA1 and BRCA2 genes.

Q: I’m an Ashkenazi Jewish woman. Should I be tested for the mutations in the BRCA1 and BRCA2 genes?
A: If you have been diagnosed with breast or ovarian cancer or have a family history of breast or ovarian cancer, you may want to be tested for one of the mutations in the BRCA1 and BRCA2 genes that are common among Ashkenazi Jews. Knowing your carrier status may help you evaluate your future risk and can be useful information for other family members. If you have cancer, the information can help shape treatment and alert you to other risks (such as a heightened risk for ovarian cancer if you have breast cancer).

While some Israeli doctors want to expand testing and make it routine, general practice in the United States has not encouraged genetic testing for individuals who are cancer-free and don’t have a family history.

But for Ashkenazi Jews, the bar for genetic testing is not as high as for the general population, said Dr. Susan M. Domchek, executive director of the Basser Research Center for BRCA at the University of Pennsylvania’s Abramson Cancer Center.

“If you’re Jewish, we have a low threshold for testing,” Dr. Domchek said. “If you have an aunt who had breast cancer at 51 and you want testing, that’s O.K.”

Keep in mind that the odds of testing positive are fairly low — only one in 40 Ashkenazi Jews, or 2.5 percent, carry the mutation. That is higher than the rate in the general population, in which fewer than 1 percent carry these mutations, but it means you have a 97.5 percent chance of testing negative.

Remember that a family history includes relatives on both sides of the family, including your father’s side.

“People ignore the father’s side of the family, and they shouldn’t,” said Dr. Domchek. “Women will come to us and say there’s no family history, but actually the dad was Ashkenazi Jewish and the dad’s mother had breast cancer at 40 – that’s a significant family history.”

Q: What if I don’t know much about my family history?
A: Many Ashkenazi Jews have limited information about their family because they lost relatives in the Holocaust. Others come from small families that don’t provide a lot of clues, and families everywhere become estranged and keep secrets. One reason Israeli doctors want to do broad-based screening of Ashkenazi Jewish women is so that individuals are not dependent on family members for information.

Nevertheless, Dr. Domchek emphasized that there is still some uncertainty about what it means if a woman tests positive for a mutation and no one in her family has had cancer. Research is trying to resolve questions about what the risk is in these cases. “It’s a challenge to give an individualized risk assessment,” she said.

If you are concerned because you have limited information about your family, genetic counseling may help clarify whether you should pursue testing.

Q: What does the test consist of? How much does it cost? Will insurance cover it?
A: The genetic test is a blood test, often accompanied by genetic counseling. Testing for the three specific BRCA1 and BRCA2 mutations common among Ashkenazi Jews generally costs between $300 and $500 for all three. Insurance coverage varies and may be more likely to pick up the cost if the individual has a clear family history of breast or ovarian cancer. Genetic testing of men who do not have cancer is generally not covered, Dr. Domchek said.

Q: What does a positive result mean?
A: A woman who tests positive for a mutation will be given a range of risk for developing breast cancer and ovarian cancer during her lifetime that takes her family history into account, but assessing individual risk is a challenge, Dr. Domchek said. “If the only history is a mother who developed breast cancer at 55 and the mother has four sisters and no one else has cancer of any sort,” then the woman’s risk will be deemed lower than if several of her aunts have cancer, she explained.

While about 12 percent of women in the general population will develop breast cancer at some point in their lives, 55 percent to 65 percent of women with a harmful BRCA1 mutation and around 45 percent of those with a harmful BRCA2 mutation will develop breast cancer by age 70, according to the National Cancer Institute. While about 1.4 percent of women in the general population will develop ovarian cancer, some 39 percent of carriers of a harmful BRCA1 mutation and 11 percent to 17 percent of carriers of a harmful BRCA2 mutation will develop ovarian cancer by age 70.

Q: What factors should I weigh when considering prophylactic surgery?
A: Choosing prophylactic surgery is a difficult and highly personal decision. Many doctors emphasize the importance of removing the ovaries, because the mutations increase the risk of ovarian cancer, which is harder than breast cancer to detect at an early stage. Israeli physicians urge women to undergo ovary removal as soon as they have had their children, preferably by the age of 40. Removing the ovaries also reduces the risk of breast cancer considerably.

The choice of whether to have a prophylactic double mastectomy is complex. Close monitoring and surveillance of the breasts with frequent magnetic resonance imaging scans and clinical breast exams is another option, doctors say. Over time, however, doctors say many women tire of the constant checkups, especially if they are called back for frequent biopsies and some eventually opt for mastectomies as a result.

Both oophorectomy and mastectomy are difficult operations that have serious side effects. Breast reconstruction often leads to infections and other complications and many women are disappointed by the look and feel of their new breasts. Removing the ovaries robs women of important hormones and plunges them into menopause overnight, leading to hot flashes, reduced sex drive and heightened risks of heart disease and bone loss. Hormone replacement treatment or other medication is often required.

Click here to read the original post from the NYTimes Read more!

Genetic Testing Should Adhere to Medical, Not Business, Ethics: FDA's Regulation of 23andMe Is a Welcome Move for Consumers

Original post by Karuna Jaggar on HuffPost Business, 12/1/13

This week the Food and Drug Administration (FDA) issued a warning letter to the direct-to-consumer genetic testing company 23andMe, demanding that it immediately stop marketing and selling its DNA testing service until it receives approval from the agency tasked with regulating medical tests and devices. In what has widely been called a "scathing" letter, the FDA said that 23andMe had failed to show that "the firm has analytically or clinically validated the [23andMe Saliva Collection Kit and Personal Genome Service] for its intended uses" and expresses concern "about the public health consequences of inaccurate results from the P.G.S. device."

It sounds temptingly light-hearted to find out about the percentage of genes you share with a Neanderthal, your earwax type, or why you love Brussels sprouts while others can't stand them. But 23andMe's test doesn't stop there. It claims to provide health reports on some 254 diseases and conditions. Some of the information the company provides, based on the saliva you send them, includes how your body may metabolizes certain pharmaceutical drugs, an individual's carrier status, and risk of disease such as Parkinson's, schizophrenia, sudden cardiac arrest, scoliosis, and Amyotrophic Lateral Sclerosis (ALS). Hardly light-hearted and recreational given the potentially life-altering implications of such information.

Genetic testing is complex and raises a wide range of medical, ethical, and scientific issues. And no one knows this better than the families who have cancer-linked mutations on the BRCA1 or BRCA2 genes, commonly known as the "breast cancer genes." Some mutations of the BRCA genes are known to increase people's risk of breast, ovarian, and other cancers. Other mutations of the BRCA genes don't increase people's risk of these cancers. And we haven't yet learned what some other rare BRCA mutations mean for a person's future risk of disease.

Until this summer, one company, Myriad Genetics, held an exclusive patent on the human BRCA genes. This monopoly meant that Myriad offered the only commercially available test for BRCA mutations, the test was expensive, you could not get a second opinion, and Myriad held exclusive rights to develop new tests and targeted therapies related to the BRCA genes.

When Breast Cancer Action joined a group of geneticists, researchers, physicians, and women with family histories of breast and ovarian cancer to file suit in 2009 with the ACLU against Myriad Genetics, not only were we challenging one company's right to patent the human BRCA1&2 genes, we were taking a stand to ensure that more women had access to potentially life-saving information about their inherited risk of cancer. An additional benefit of ending Myriad's monopoly is that new companies could offer new and better tests, utilizing advances in technology. During the years when Myriad held an exclusive monopoly on the human BRCA genes, rapid technological advances meant that the cost of genetic sequencing dropped dramatically, yet Myriad doubled the cost of their BRCA test over this same time frame. And indeed, the very day that the U.S. Supreme Court ruled in our favor in June, approximately half a dozen companies announced they would begin offering BRCA testing for a fraction of the cost.

Some people have drawn a link between the BRCA case and 23andMe's test by applauding direct-to-consumer companies for making people's genetic data accessible to them for just a couple of hundred dollars. And there are those who argue that the FDA's move to block one direct-to-consumer company's genetic testing is a move to block people's right to discover their own genetic information. Yet, the truth is that these companies, including 23andMe, go beyond genetic sequencing by offering interpretation of your test results. And this is where some of the most complex ethical, medical and scientific issues emerge--in understanding what our genes mean.

The truth is that we still understand very little about how our genes interact with our environment, and our individual choices, to impact our health. Despite the many advances in genomics, we still don't understand much about genomics at a most basic level. Even some of the most well-studied genes, such as the BRCA 1 & 2 genes discussed above, don't tell a person if she'll get cancer. After all, some women with these mutations never get cancer, and we don't know why.

Most genes are not nearly so well understood as the BRCA genes. We simply don't have the scientific evidence to know what mutations of most genes mean. Yet, direct-to-consumer companies like 23andMe are willing to make interpretive claims about some of these genes, despite the high risk of false positives and false negatives.

The FDA is asking 23andMe to demonstrate that its medical service is analytically and clinically validated. Validation includes both the analysis of people's saliva samples to conduct genetic sequencing and also the interpretation of these results to predict future risk of disease. While there are standard protocols followed by most labs that enable them to conduct DNA analysis, a number of studies have demonstrated that different clinical validation methods of different direct-to-consumer companies means that the same person can get different results from two different labs. A person may be told by one lab that they are at increased risk for disease and the same person may be told by another lab they are at below average risk of the same disease.

This problem of inadequately validated claims of clinical significance cannot simply be solved by saying these tests, like those offered by 23andMe, are for entertainment purposes only. 23andMe is making bold claims about a person's medical future, risk of disease, and responses to particular drugs. And the basis of 23andMe's claims, these predictions, must be subjected to rigorous scrutiny, peer review, and yes, FDA regulation.

While no one company should hold a monopoly on genetic testing, we also can't assume that every new test is a good test. All genetic testing should be properly validated to ensure the methods of testing and interpretation fulfill the intended purpose and provide meaningful and accurate information. Medical data ought to be shared with open-access databases for the benefit of scientific and medical advances. Testing should be accompanied, both before and after testing, with independent genetic counseling. And corporate marketing practices should not overpromise the benefit of genetic testing or drum up people's fear of disease.

Arguably, the primary compensation that consumers give to companies like 23andMe is access to their genetic and family histories. With nearly half a million people having given 23andMe their DNA and their family history, we must address issues of privatization of genetic material. Indeed, others have addressed the fact that 23andMe has used its vase database of genetic and family history to get a patent on "gamete donor selection based on genetic calculations". We need not focus on the controversy about "designer babies" which ensued, to see that 23andMe is using its customers' biodata and familial information to launch new business products, again with vast moral, medical, and scientific implications.

The key lessons we learned from Myriad monopoly on the "breast cancer genes" are not only that genetic testing is fraught with moral and medical complexity but also that, as a medical service, genetic testing must adhere to medical rather than business ethics. Public health and patient protection should come before company profit. And this week the FDA has taken a welcome stand to protect public health by insisting that what is clearly a medical service be regulated as such. While we continue, as a society, to sort out how to use genetic information to best serve the public's health, I am glad to see this move to regulate genetic testing according to medical rather than business ethics.

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Here’s why the FDA is targeting 23andMe

Original story on medcitynews.com by Christina Farr, 11/26/13

Monday morning, federal regulators issued an enforcement action against 23andMe, a popular Silicon Valley-based genetic testing startup.

Community forums and news sites across the web exploded with debate, with most people rallying to 23andMe’s defense. The company’s ample support-base claims that the Food and Drug Administration is over-regulating, and is stifling innovation.

However, the majority of geneticists and medical professionals I’ve spoke with have sided with the Food and Drug Administration, arguing that many patients require genetic counseling after receiving DNA test results that point to a high risk of cancer and other life-threatening conditions.

One San Francisco-based neurologist, who asked to remain anonymous, told me that some of her healthiest patients — all 23andMe customers — have begun demanding unnecessary and expensive MRI tests for Alzheimer’s Disease. “23andMe’s test is creating chaos with people in their 20s and 30s,” she said. “They generate havoc and walk away.”

Indeed, in the event that this divisive case reaches the California courts, it may have far-reaching implications for the genetics industry and beyond.

23andMe: How it works

Google-backed 23andMe is among the first to market and sell an affordable DNA test directly to consumers rather than to care providers. The company is backed by Google and run by Anne Wojcicki, the soon to be ex-wife of the Google cofounder Sergey Brin.

On its website, 23andMe claims that it is “saving lives” by delivering clinical insights, such as your risk of developing breast cancer or Parkinson’s Disease. The company says in its marketing materials that it will provide “health reports on 254 diseases and conditions.”

23andMe also sends you information about your ancestral history and frequently describes this process in ads and blog posts as “empowering” and “fun.”

That’s all well and good, but the FDA is contending that 23andMe’s method of amassing DNA — its Saliva Collection Kit and Personal Genome Service (PGS) – is a class III medical device under the Federal Food, Drug, and Cosmetic Act. The device has not obtained proper regulatory clearance and is therefore misbranded under the law.

In its letter, originally issued on Friday, the FDA explains that the kit falls under the medical device category, as consumers could act on the results as a diagnosis — not just a prediction of risk. Regulators are concerned that a false positive from a 23andMe test could result in unnecessary surgery and that false negatives could lead to patients being less aggressive about screening for various health conditions.

The agency may have decided to take public action now, given that 23andme has begun testing various mutations of genes that indicate a woman might have a high risk of getting breast or ovarian cancer. A false positive on that test could cause a woman to undergo a needless mastectomy. And a growing number of women are requesting this test after hearing the news about Angelina Jolie’s surgery.

23andMe has 15 days to provide specific actions to address the issues raised by the FDA. At the time of this report, kits were still for sale on the company’s website.

Taking a stand

23andMe may choose to comply with the FDA, or it may argue that its PGS is not a medical device at all.

Lauren Fifield, a senior health policy expert predicts that the company will take a stand. “My gut tells me that the company isn’t challenging process but is instead challenging the very regulatory definition of what it is to be a device,” said Fifield, who works closely with startups, the FDA, and other federal health agencies in her role at Practice Fusion.

“What remains to be seen is whether the company and tech industry can convince the government that safety can be increased, or at least balanced, by innovation rather than set at odds,” she added.

23andMe is well funded, with an in-house legal counsel and policy team. The company has not responded to a request for an interview from any news publication, presumably as it convenes to determine a course of action.

In response to requests for information, 23andMe issued the following statement.

"We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

Note the use of the term “expectations” rather than rules or requirements, which suggests that 23andMe is not convinced by the FDA’s arguments.

The FDA, meanwhile, made clear in dealings with the media that it is taking a hard line. This letter was not delivered out of the blue. The agency says 23andMe has dragged its feet despite “14 face-to-face or teleconference meetings, hundreds of email exchanges, and dozens of written communications” since 2009.

“Companies that receive warning letters have the opportunity to address the violations,” explained Erica Jefferson, a spokesperson with the FDA, in an interview with VentureBeat. “If the violations are not addressed to the satisfaction of the FDA, further actions may be warranted, including seizure or civil money penalties.”

It’s all about the messaging

This case is still developing, but one crucial lesson for health entrepreneurs is that the FDA pays a great deal of attention to messaging.

This rule of thumb doesn’t just apply to genetic testing. The FDA recently clamped down on a mobile medical app called uChek, pointing out that the company’s marketing was misleading. The agency is more inclined to take action if an app promises to deliver an alternative to a doctor’s visit.

To the agency’s credit, developers have found it far easier to avoid federal oversight. For reference, the FDA recently released its final guidance on how it intends to regulate mobile medical apps.

In this particular case, the FDA may have taken issue with 23andMe’s aggressive marketing tactics. The company recently hired a former Gilt Groupe exec as its president; since then, it has been advertising its test to consumers on social media and various television networks.

Consumers may not understand that the test is serious — not just a bit of fun — and that the results can indicate incurable or life threatening disease.

“When I started Navigenics (a 23andMe rival that was acquired by Life Technologies for an unspecified sum), we spent an enormous amount of time communicating shades of grey — and we did all this alongside regular meetings with the FDA,” said human geneticist and entrepreneur Dietrich Stephan in an interview.

“Engaging the FDA as a partner to bring the most robust and safe new type of test to market is “diagnostics 101,” he added.

Stephan told me about a family friend who ordered a 23andMe test on a whim. His mother felt compelled to take the test, after discovering that her son carried a genetic variant called BRCA, which indicates a high risk of breast and ovarian cancer. After the mother received a positive result, she ordered a double mastectomy despite protestations from friends and family.

Indeed, physicians I interviewed stressed that patients should not order a DNA test without regard to the consequences. Dr. Malcolm Thaler, a primary care provider at One Medical, said he would prefer to have a conversation with a patient before they order a test “to put the results in context” and explain the numbers in detail.

In the short term, we may seen 23andMe under pressure to more readily link consumers with genetic counselors and adapt its marketing campaigns to reflect the life-changing and potentially very serious nature of the results.

Is this a landmark case?

The crux of the issue is that the FDA is still determining how it will regulate innovative health applications from Silicon Valley and other technology hubs. Health policy experts, like Practice Fusion‘s Fifield, believe this has the potential to be a “landmark case” if it goes to court.

Already, the public warning letter will serve as an important example and model for other startups.

“I’ll be watching how this case plays out,” said Heather Heine, an M.D. and founder of an early stage biotech company called Talking20. Heine doesn’t have such immense resources at her disposal as 23andMe to hire expensive consultants.

So Heine will keep a close eye on how 23andMe responds as she brings her company’s low-cost biomarker testing kit to market. “23andMe has the resources to push this envelope,” she said. “These resources allow them to be front-runners.”

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F.D.A. Demands a Halt to a DNA Test Kit’s Marketing

Original article by Andrew Pollack, NYTimes, 11/25/13

In a crackdown on genetic testing offered directly to consumers, the Food and Drug Administration is demanding that 23andMe immediately cease marketing its main DNA service until it receives marketing clearance from the agency.

In a warning letter issued Friday and posted on the F.D.A.'s website Monday, the F.D.A. said that the company had failed to provide adequate evidence that its Personal Genome Service provided accurate results.

“F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter. “The main purpose of compliance with F.D.A.'s regulatory requirements is to ensure the tests work.”

23andMe, which is backed by Google and run by Anne Wojcicki, wife of the Google co-founder Sergey Brin, is perhaps the best known of the personal genome testing companies. Its service, which has been used by about half a million people, tells consumers whether they might be at a higher or lower risk of developing various diseases, among other things.

Whether such tests require F.D.A. approval and whether doctors must be involved in ordering such tests have been the subject of debate. 23andMe has long held that consumers are entitled to the information on their own DNA, though it has also been talking to the F.D.A. about how its tests could receive regulatory approval.

Ms. Wojcicki did not immediately respond to an email seeking comment and her company, which is based in Mountain View, Calif., had not yet responded on its website Monday morning.

The F.D.A. warning letter said the agency considered the Personal Genome Service a medical device that required approval.

The letter noted that 23andMe did apply for approval for some uses of the test in 2012. However, it said, the company did not provide the additional information requested by the agency, so the agency considered the applications to have been withdrawn.

The letter accused 23andMe of dragging its feet despite “14 face-to-face or teleconference meetings, hundreds of email exchanges and dozens of written communications” since 2009.

“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the P.G.S. for its intended uses, which have expanded from the uses that the firm identified in its submissions.”

The letter added, “Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the P.G.S.'s uses and consumer base without obtaining marketing authorization from F.D.A.”

What seems to have raised the most concern from the agency is 23andMe’s expansion into offering tests for mutations of genes that indicate a woman might have an extraordinarily high risk of getting breast or ovarian cancer. The F.D.A. said a false positive on that test could cause a woman to undergo a needless mastectomy.

The agency also seemed concerned about 23andMe’s expansion into testing of genetic variants to help predict people’s responses to drugs such as warfarin, a blood-thinning medication.

23andMe now sells its service, which also offers ancestry information, for $99. It is aiming to grow to 1 million customers by early next year. Part of its business plan is to use the information on its customers to perform biomedical research, such as finding genetic causes of diseases.

The F.D.A. first sent letters to 23andMe and some of its competitors in 2010, saying that regulatory approval would be required for the tests. Following that, some of the other companies stopped offering tests directly to consumers.

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