In reporting on the recent March 8-9 meeting of the MCG Panel of the FDA's advisory committee, I find it problematic that I have no recording or minutes of the meeting. Of the five W's of reporting, I am missing the vital Who and hoW components. So, I was taken by surprise yesterday as I was working on my call to nursing organizations to submit comments to federal docket FDA-2011-N-006 in support of patients' rights to view their own genetic information. It turns out the American Nurses' Association has already weighed in on this matter by sending Ann Maradiegue of George Mason University to testify before the panel on March 8th. The ANA has endorsed her testimony, which is available in PDF format from NursingWorld.org.
In reading Dr. Maradiegue's testimony, I was struck by how much she seems to stay "on message." It leads one to speculate that, as Dan Vorhaus and Daniel MacArthur have suggested, the outcome of the MCGP meeting was pretty much a forgone conclusion. For a fact-finding meeting, Dr. Maradiegue presents little transparency of the assumptions and reasoning underlying her testimony, while the research she presents tells us only that the industry is currently unregulated, which everyone knows. She presents no evidence in support of her implied preference for a "routed through a clinician" standard of regulation. The meeting, indeed, appears to have been an exercise in consensus-building rather than fact-finding.
Speaking as a nurse, I cannot endorse or agree with Dr. Maradiegue's testimony. She and the ANA claim to speak for all nurses on this matter. She told the MCGP that, in her testimony, she would inform them "what the nursing profession’s perspective is on the regulation of genetic tests, including Direct to Consumer genetic testing." However, she did not. If she had, her talk would have included statistics on professional opinion research conducted by the ANA. Instead, she has simply reiterated the opinions of select members of the ANA leadership. As the ANA does not license nurses or count them all as members, this is not the "nursing profession's perspective".
Therefore, I feel obliged to send Dr. Maradiegue and the ANA the following open letter critiqueing their statements and asking them to revise their position.
Ann Maradiegue, PhD
School of Nursing
George Mason University
Dear Dr. Maradiegue:
As a nurse, I would like you to know how strongly I disagree with your March 8 testimony for the FDA on direct-to-consumer genetic testing and encourage you and the ANA to submit new comments on federal docket FDA-2011-N-0066.
In the coming era of cheap gene sequencing, access to and control of personal genomic data will--and should be--seen as a human right. Your testimony implied that health care professionals should be a protected category of Americans with an exclusive right to order and receive the results of genetic tests. As you must be aware, when whole genome sequencing becomes affordable in the near future, this standard of regulation must result in a denial of access to fundamental information about Americans' personal histories and relationships to our species and its development.
Moreover, your implicit suggestion that health care providers' interpretive abilities keep patients safe is disingenuous in multiple ways. First, as Bloss, Schork, and Topol (2011) demonstrated, the available evidence shows no harm to consumers in DTC genetic testing. Second, as you well know, neither APNs nor MDs receive education that specially qualifies them to interpret genetic data. Third, your comments presuppose genetic testing in the context of acutely or chronically ill patients when the FDA is considering regulation of all genetic testing. Fourth, your comments present a false dichotomy between an unregulated industry and clinician control of access to genetic data when a range of regulatory rules are possible that would not restrict Americans' access to their own personal genomes.
That genetic testing interpretation is complex and uncertain is due to the fact that genomewide profiling of the type offered in DTC testing is not diagnostic but reflective of risk, risk that is also found in lifestyle choices about exercise, substance use, and nutrition. In these other areas, knowledge of risk (and even advice about risk reduction) is openly available to patients without clinician intervention. Nurses should support a regulatory scheme that would promote testing accuracy but make information about genetic risks as available to Americans as information about lifestyle risks.
Your testimony puts you and the ANA, in the words of former President Clinton, "on the wrong side of history." Rather than leading change and advancing health, your testimony promotes social and technological stagnation that will send innovative industries overseas. Rather than promoting patient rights, your testimony acts as a handmaiden to the American Medical Association's docket comments and their misguided guild mentality toward the future of medicine. This guild mentality is reflected in your call for federal funds to educate nurses about genetics when you could have easily called for federal funds to improve science education and increase public knowledge of genetics.
I call on you to revise your position on DTC genetic testing. Your testimony's implicit support for the AMA's recommendation of a "routed through a clinician" regulatory standard can be undone by an explicit statement that this standard should be rejected. The FDA has re-opened its comment period for federal docket FDA-2011-N-0066. I encourage you and the ANA to submit comments in support of DTC regulation that would ensure the accuracy of consumer genetic tests while maintaining free and open access to their own genomes for all Americans.
Thank you for your attention.
[Updated March 15, 2011: Dr. Maradiegue responded to my e-mail by asking for my full name and "background information." While this is reasonable in polite society, it is also what someone would do if they intended to silence you by exerting professional pressure. No accusations here, but we must say "c'est la vie" and leave it at that...]
Bloss, C., Schork, N., & Topol, E. (2011). Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk New England Journal of Medicine, 364 (6), 524-534 DOI: 10.1056/NEJMoa1011893