Misinformed Outrage Over FDA Letter to 23andMe

Tonight, I read an excellent post on the website KevinMD* supporting the FDA's recent action against 23andME. 23andME offers broad genetic testing to the public.** The comments that followed raged that it was ridiculous for the FDA to regulate the tests as a 'device' since the tests are not a device and that the FDA was interfering with patient freedom by outlawing these tests. Not so fast. As a doctor and occasional lawyer, let me explain why the commenters are thoroughly misguided.

First, 23andMe can still market the tests.** They have simply barred the company from making bogus interpretations and unsubstantiated claims about what the tests can do. For why that matters, see the post on KevinMD.*

Second, the tests are a 'device' in this context. Sometimes, lawmakers and regulators use common words as shorthand for specialized concepts. The shorthand is spelled out within a particular law or regulation for use in that context only. Common usage is not relevant. As the FDA says in its letter, and as 23andMe surely knew, "this product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."***

23andMe claimed that their tests were the ' “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer.' The FDA offered them the opportunity to substantiate these claims. They ignored the offer. Theirs is exactly the sort of behavior the FDA was founded to regulate.

So please, disagree with the law if you like, but read before you rage.


[PLEASE MAKE ALL COMMENTS WITHIN THE BLOG. NOT EVERYONE HAS FACEBOOK.]

* (http://www.kevinmd.com/blog/2013/12/23andme-providing-data-physicians-manage.html) 

** (https://www.23andme.com/ancestry-only-notice/?redirect=Od5SRaMng_bubQswwbkFyONDrnQDavEBPlg5nNjo754=) 

***(http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm)

Too Much Information: Medicine and National Security

This is not a very 'Tumoriffic!' update. My health is fine right now. This is about current events. It is not an exhaustive or radical post, just an analogy that occurred to me as I considered doing a particular test on a patient.

*******************************************************************************

There is such a thing as too much information--too much of the wrong kind of information, or information too dearly bought. This is true in medicine, and I believe it is true in national security.

Beginning in the late 1800's, burgeoning technology granted us more and more power to image and measure the body as never before. The number of screening tests ballooned. One might assume that the that early detection--more information--would automatically lead to fewer deaths and less misery. That is not always the case.

Similarly, technology has granted our government power to monitor private individuals as never before. The advocates for this technology believe that it will automatically lead to fewer deaths and less misery.* I am skeptical. I think it is human nature to overestimate benefits and underestimate risks of new technologies in all fields. National security should learn from medicine.

Sometimes, information can lead us down destructive paths. We used to test every middle-aged man's PSA instead of limiting the test to those at high risk. Unfortunately, most men with a high PSA did not have prostate cancer, most prostate cancers would not grow fast enough to impact lives, and treatments were (an are) risky. For every 1,000 we tested, we terrified over a 100 with a 'positive result.' The resulting biopsies and treatment left 29 of those men impotent and 18 in diapers. They gave two men heart attacks, and one man a blood clot in his lung. One man may have died due to the treatment, and one man might have lived longer. (http://www.cancer.gov/cancertopics/factsheet/detection/PSA) The PSA test gave us more information, but we did not know what to do with it.

In medicine, we gloried over the supposed prostate cancer deaths averted and did not see the harms. In national security, they tout the terrorist plots foiled, but, inevitably, innocents are harmed. (e.g., http://www.portlandcopwatch.org/PPR34/PJTTF34.html, and http://www.humanrightsfirst.org/our-work/refugee-protection/refugees-falsely-accused-of-terrorism/page/2/)

Sometimes, the very act of gathering information is harmful. For at least 70 years after the invention of the x-ray, doctors routinely x-rayed pregnant women to image the fetus and evaluate the pelvis to plan delivery. As first publicized by British physician Alice Stewart in 1958, this could increase the child's risk of cancer by a factor of ten.  The x-ray may have prevented some delivery complications, but it caused millions of cancers. (http://www.ratical.org/radiation/KillingOurOwn/KOO6.html) The NSA's inquiries are showing harms much more quickly. (e.g., http://www.reuters.com/article/2013/11/13/us-usa-security-hearing-idUSBRE9AC0S720131113, http://legalinsurrection.com/2013/11/lavabit-founder-i-had-effectively-lost-the-ability-to-control-my-own-network/, and https://www.aclu.org/blog/national-security/you-may-have-nothing-hide-you-still-have-something-fear)

These are but a few examples. In national security as in medicine, technology has given us powers once only attributed to gods. It is natural to want to use them to try to prevent all of the disease or evil in the world. Sometimes, however, the prevention is worse than the disease.


* Note that I am not going into questions of motives. Instead, I am taking as a given that most in the medical profession want to heal, and most in national security want to protect.

A Non-Heroic Act

This is from a comment I originally posted on at http://www.kevinmd.com/blog/2013/06/ehrs-talk-work.html.

Recently, a patient who was away on vacation paged me with very worrying symptoms. I told her to go immediately to the nearest emergency room. I then printed out and faxed an automatic face sheet containing her diagnoses, medications, adverse drug reactions, and most recent vitals and labs. Next, I called the emergency room to which she was headed and briefed the attending physician. This physician later informed my patient that my 'remarkable' handoff was part of what saved her life.

This should not have been a 'remarkable' handoff. My electronic medical record system should have sent most of the relevant information automatically and instantaneously even had I not been near a fax machine and had not had immediate access to the medical record and a printer.

In every other aspect of society, your privacy is for sale to anyone who wants to violate it. Only in medicine, where effective information exchange done in your own interest can save your life, is privacy protected so jealously. Medical information 'siloing' (maintaining medical record systems that do not talk to each other) creates endless administrative costs, delays, redundancies, and avoidable errors. This means everything from visit notes to radiology, current and previous med lists, adverse drug reactions, diagnoses, other providers' contact information, patient contact information and next of kin. Don't think communication of this information is important? How well do you think a hospital would work if, every time a new doctor walked into your room, they had to gather and record all of your information from scratch? How much extra time and money would they burn gathering old facts? How much more likely would you be to die? If it makes no sense within a hospital, it makes no sense between hospitals.

Sophisticated patients can mitigate this somewhat by keeping their own copy of important health history, but if you have had a serious illness, your history quickly becomes immensely complicated. It is hard for even a medical professional to always know what parts will be important. This is nothing compared to the challenge for patients who are just not sophisticated in the ways of medicine or computers or for the people who tend to be the sickest--those who are demented or otherwise intellectually or psychiatrically impaired.

Getting my patient's information to that ER physician was no heroic act. It was doable because I happened to be in a location where the information was easily accessible, and I had the time and means to transmit it. But, unfortunately, such handoffs are not common. They should be.