23andMe provides personalized
DNA results that are interpreted to provide information about ancestry and
health risks for various diseases. Because the results provided by 23andMe
border on medical information, the FDA has been working closely with the
company since 2009 to ensure that their marketing and analysis were accurate
and in accordance with federal regulations. However, in May of 2013 23andMe ceased
communications with the FDA and simultaneously ramped up marketing of their
Personal Genome Service (PGS) for providing “health reports on 254 diseases and
conditions.” In retaliation, the FDA sent a letter
to 23andMe on Nov 22 warning them to stop marketing their PGS without approval
or face harsh regulatory actions. This letter sparked a public debate about how
much regulation should be imposed on this new technology, which was the focus
of our discussion on Wednesday.
The question at the heart of the debate is: do individuals
have the right to access their own genetic information (and interpretations of
it) without medical (and hence FDA) oversight?
The laissez-faire argument is that individuals have the right to know their genetics, and governmental paternalism should not restrict that access over fears that certain individuals might react negatively to their DNA interpretations. For instance, a woman might find out she is slightly predisposed to breast cancer and get an unnecessary radical mastectomy (for which it might be challenging to find a doctor that would perform this procedure solely based on the 23andMe PGS, anyways). These scenarios shouldn’t prevent more responsible people from obtaining it. To their credit, 23andMe is very open about allowing people to access more information regarding their personalized interpretations. Curious users can find detailed explanations and links to scientific studies if they care to investigate.
The laissez-faire argument is that individuals have the right to know their genetics, and governmental paternalism should not restrict that access over fears that certain individuals might react negatively to their DNA interpretations. For instance, a woman might find out she is slightly predisposed to breast cancer and get an unnecessary radical mastectomy (for which it might be challenging to find a doctor that would perform this procedure solely based on the 23andMe PGS, anyways). These scenarios shouldn’t prevent more responsible people from obtaining it. To their credit, 23andMe is very open about allowing people to access more information regarding their personalized interpretations. Curious users can find detailed explanations and links to scientific studies if they care to investigate.
Those in favor of regulation argue that the accuracy of the
PGS needs to be verified. They caution that faulty tests could cause
unnecessary worry and lead to increased healthcare expenditure to verify or
refute the result. The FDA states that most of the intended uses for PGS are
consistent with uses that regularly require approval by the FDA. The rationale
in favor of regulation is that a company marketing its genetic test as health
information should be required to demonstrate the information is correct and
reliable. More debates arise from this point about what is correct and reliable
and who should determine it. 23andMe insists that the FDA needs to set clear
guidelines on this technology before it is feasible for them to comply.
That, in essence, was the purpose of the ongoing
communication between the FDA and 23andMe. To many people, it appeared strange
that 23andMe all of a sudden ceased talks with the FDA. Some have hypothesized
that it was a marketing ploy, and one that seems to have worked thanks to
extensive media coverage. While it is too soon to determine their motive for
severing communication, currently 23andMe has resumed talks with the FDA and halted
their health-related genetic reports (ancestry is still available). The CEO Anne Wojcicki commented that their “goal is to work cooperatively
with the FDA... to make sure
consumers have direct access to health information in the near future.”
It will be
interesting to watch this process unfold. In the future personal genetic tests
will become more popular as our knowledge of human genetic variation and
disease grows, so the regulation of 23andMe will be crucial to set the standard
for other companies offering this service.
What do you think
about the FDA regulating 23andMe? Comments are welcome.
For additional
reading, see:
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