Challenge to Michael Nierenberg, Medical Director of Navigenics
Michael Nierenberg, Medical Director of Navigenics comments on “Absence of “High Penetrance” in SNP Genomic Services” regarding my statement “existing SNP genomic services just aren’t that useful.” (comment appended below)
Rather than entertain an “ongoing discussion” about “preferences” and confidence, this debate about Navigenic’s efficacy can be immediately resolved with a simple concrete response to the following challenge:
Dr. Nierenberg, as a physician, what action would you almost certainly prescribe given a Navigenics test result which you would almost certainly not prescribe without that information?
Assume no bound on cost. Please remember that you must also defend why you would almost certainly not prescribe the given action without the genomic information if cost were no issue. For example, any non-invasive screening test would be a bad example because one could reasonably prescribe the test to all cost-insensitive patients without genomic testing.
Additionally, you may respond with an economic argument. As of 2008, state an approximate dollar amount savings for what healthcare spending and by what savings mechanism (e.g. insurance reimbursement, state provider). State as an expected net present value savings per average American greater than the cost of the net present value cost of a Navigenics test ($2500 + $250 each year for life). If you respond with an economic argument, you must respond with a falsifiable savings hypothesis specific enough to be tested by real patients.
Please respond within one month, though sooner would be better considering Navigenics has been for sale to consumers for several months as a cost-insensitive service for improved healthcare efficacy, and I thus hope Navigenics has a long list of excellent responses to this efficacy challenge already prepared.
To be fair, I will meet this challenge immediately for BRCA testing.
Cost-Insensitive Efficacy Challenge: BRCA
Test: BRCA 1&2 genomic test by Myriad
Physician Advocate: Dr. Barbara Ward, surgical oncologist at Yale-New Haven
Action: prophylactic bilateral mastectomy (the removal of both breasts before evidence of cancer)
Positive Clinical Precedence: Jessica Queller. In fact, she wrote a book about it which she discusses at Helix: Jessica Queller and “Pretty is What Changes” [audio]
Physician Testimonial:
Dr. Barbara Ward: “In terms of managing hereditary [breast cancer], I have to say as surgeon, I believe very much in prophylactic surgery. I look forward to the day that we’ll look back and say ‘can you actually believe that we did mastectomies for [BRCA] gene carriers?’ but at this point in time it is the best that we can offer.” Source at Helix [audio]
Why Action is not prescribed without genomic information: Action is removing a woman’s healthy breasts
Other relevant qualified action: testing for family, oophorectomy, fertility counseling
I am unable to make an additional economic argument that meets my challenge criteria.
Thank you for your comment, Dr. Nierenberg, and we anticipate your response. I understand you and your team at Navigenics are genomic enthusiasts, but Navigenics markets itself as a genomic test held to a high medical standards of efficacy that other genomic tests are not. I and others simply are yet unconvinced regarding that advertised usefulness. Please help better inform us.
Appendix
Dr. Michael Nierenberg’s original comment [source]:
Mr. Andrew Yates offers the following comment in Absence of “High Penetrance” in SNP Genomic Services about espousing the uselessness of genetic testing by companies such as Navigenics:
“The reality is that except for a few enthusiasts (like anyone in the DNA Network, including myself), existing SNP genomic services just aren’t that useful. It’s not useful to know that one has a 7% lifetime risk rather than a 5%. I need to know risks of about 40% and higher.”
In response to Mr. Andrew Yates I offer the following information about lifetime risk assessments offered by Navigenics (http://www.navigenics.com).
On the Navigenics HealthCompass six conditions have a lifetime risk potential that exceeds 35% (Five conditions exceed 40%). Since some conditions are less common in the population, it is useful to also consider relative risk, as opposed to absolute risk.
Half of all 23 conditions reported have a relative risk (compared to the average genetic risk in the general population) greater than 2; seven conditions, greater than 3; and three conditions greater than 4. For comparison, this level of relative risk is in line with other well-accepted, commonly used risk factors such as positive family history and environmental risk factors (high lipids, age at menopause etc.)
I hope this clarifies things for Mr. Yates who can now feel better about being an enthusiast.
I would also ask Mr. Yates to reconsider his statement about why Navigenics is not doing BRCA testing. Patent considerations aside, it is of import only in about 5% of breast cancer cases (those with “extreme” positive family histories and early age of onset). The contribution of BRCA1/2 mutations in sporadic breast cancers has not been determined conclusively. Our preference is truly to offer a test that is applicable to the majority of individuals. We are cognizant that in a minority of people BRCA testing is important and have addressed this issue on our web site in several places. We realize that no test is complete in and of itself; otherwise people would have heart surgery based only on a treadmill. So, I would ask Mr. Yates to please give us credit for more than trying to get around patent considerations. We are enthusiasts as well.
Think Gene at Technorati
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