February 24, 2011
Daniel MacArthur On Freedom Of Genetic Info And Paternalism
the American Medical Association's vile letter calling for a revocation of consumer rights to get their own genetic tests (really FuturePundit, stop holding back and tell your readers what you really think), Daniel MacArthur says the letter shows how the AMA struggles valiantly to keep medical paternalism alive.
In other words, the AMA is seeking to maintain its members’ traditional monopoly over the interpretation of genetic information – and they expect regulators to act as their enforcers, beating down the upstart DTC genomics companies who have wandered onto their sacred turf.
This is, of course, an absurd, desperate demand. If doctors think that people should consult them about their genomes, they shouldn’t run crying to the regulators to provide the necessary force; instead,
they need to convince the public that a medical consultation adds genuine value to their genomic information. Unfortunately for the AMA, right now it’s far from clear that this is true: in many cases, DTC genomics customers are far better equipped to interpret their results than their doctors are.
Hey other bloggers: You too should be reacting to this outrage from the AMA. Reihan, Glenn I'm talking to you. Bureaucrats in the FDA are looking for cover such as this AMA letter to justify what they already want to do: crack down on direct-to-consumer (DTC) genetic testing. A crackdown on genetic testing might also open the door to a larger crackdown on DTC medical testing. Beat the drums against this.
The explosion of genetic and other information about the human body is so huge that single human minds can not be expected to get anywhere near mastering it. A general physician needs to know so many things about diseases, symptoms, diagnostic techniques, and treatments that it is ridiculous to suppose they can become experts on interpreting genetic information. It is a case of much more than
one bridge too far. Interpretation will be best done by using web sites (commercial or otherwise) that specialize in the field. Get your data. Then pay for competing interpretations or go for free interpretations. Keep the government out of it.
Razib Khan also takes a dim view of the AMA's pretensions.
Razib says you are what you are whether you know it or not and he sees marginal increases in self knowledge as tasty.
Over the past six months I’ve gotten really into analyzing genotypes of friends & family. Sometimes I talk about this excitedly, and people worry about the “risks.” When I ask what risks they’re worried about, usually people offer the vague and content-free fear of “what you could find out.” First,
if you have family information, that’s usually much more powerful than the “disease risk” estimates that these firms are giving you. In 99% of the cases, if that’s your primary concern it’s not worth the money. Second, if you’re terrified about what ancestry inference might tell you, probably you should see a shrink. You are what you are, and you’ve always been what you are. As a matter of common sense psychology, on the margin a change in self knowledge can have a big effect, but usually it is just informational icing on the cake.
Naturally, this brings to mind
John Prine and Dear Abby.
The trend in the U.S. toward reducing personal rights/choices seems unstoppable.
This is just one more item to add to the growing list of what is forbidden.
Looks like authoritarian enlightened bureaucrats are now always entitled to interfere in the lives of the benighted.
Then, too, a guild has to protect its income sources.
I'm no fan of regulation for its own sake, but I'm not sure I see how demanding to have certified professionals involved in the process of discovering medical information is nothing but bad.
For starters, it occurs to me to wonder about confidentiality issues. If the provider of a genetic test is not himself a certified medical practitioner, for example, does that mean that the genetic information is not legally covered by patient-doctor confidentiality, since the testee is not the company's "patient" in either a legal or medical sense? Would it be easier to get access by warrant to the records of a DTC genetic tester who wasn't part of the AMA? Does the decision to get a DTC test constitute by definition a waiver of medical privacy? Regulation can work to keep the government out of your business as well as pulling it into it.
Secondly, while the few customers right now investing time and money to get their genomes tested may know enough not to need a physician's involvement, they are the "early adopters", the people with the time, money and interest not to need support or assistance. As genetic testing becomes cheaper and more widespread, the customers who need more help in understanding the tests' information will sharply increase at the same time the private companies who see opportunities for profit in cost-cutting and deficient service will increase. And the level of harm that could be done with a misunderstood or incorrect genetic profile is a lot more than typically happens with a misunderstood or fraudulent diet. I can appreciate the AMA wanting to act to prevent that rather than waiting to have to clean it up.
Of course the AMA is acting to protect what it sees as its members' prerogatives and authority; that's what professional associations do, and it's neither outrageous nor immoral in itself. But to suggest that the vast majority of actual practicing medical professionals are attempting to "horn in" on patient decisions purely out of self-protective guildsman paranoia does a big disservice to most of them, I think. Given that even today, a distressing number of private vendors claim (without justification) to be able to give you better info or more effective medicines than the medical establishment (we call those vendors "quacks"), it's hard to blame the AMA for reacting defensively.
As a followup, this is the part of the AMA letter that neither this post nor WIRED quoted:
"A 2010 report issued by the Government Accountability Office (GAO) included startling findings from an undercover audit of commercial entities offering genetic testing, including inconsistent and conflicting test results, invalid scientific claims, and, in a clear violation of rules governing who may practice medicine, unqualified company employees providing misleading and inaccurate diagnostic information concerning a customer’s genetic test results. These finding underscore the importance of regulatory standards by which these commercial entities should be required to abide. ...A recent study (Bloss et al., 2011, NEJM) found that consumers who shared the results of DTC genetic tests with their physicians were more likely to pursue healthier behavior, such as lowering fat intake and increasing the intensity of exercise."
I appreciate the value of
caveat emptor, the resentment of paternalism and of interference with access to private information, but caveat emptor is far less appealing when health and lives are at stake, and ensuring the accuracy of information is always going to involve some involvement in disseminating it.
It seems that if medical testing is less regulated, many cheaper solutions will become available. The Government can still be useful by certifying WHICH tests are more reliable, but deregulation would dramatically reduce the prices as competition is encouraged.
Similarly, the annual incomes of doctors is astronomical because medical schools intentionally accept a lot less students than the pool of qualified candidates.
Parts of the country with more doctors per capita also have higher overal medical expenses per capita. Medical costs aren't susceptible to simple solutions like increasing the supply.
'to suggest that the vast majority of actual practicing medical professionals are attempting to "horn in" on patient decisions purely out of self-protective guildsman paranoia...'
But that isn't how it works. You are right - most doctors, perhaps even the vast majority, would probably not care one way or the other about this issue. But the AMA is not some sort of representative of the will and opinions of the median doctor; it's staffed by people who do care about these turf issues and who will act to defend doctors' financial interests aggressively.
You write like you are a medical doctor. Maybe you are even an AMA official.
What are people going to do with their genetic information that is going to hurt them? Do get specific. How are lives at stake?
GAO: "rules governing who may practice medicine": I will rephrase: "Rules restricting anyone besides doctors from interpreting health data". Really, I think if we apply that rule consistently then most books and blogs that write about nutrition, diet, exercise programs, and the like are breaking the law.
I remember that, decades ago, Americans complained that social security numbers would be used as personal identifiers by business and government. Politicians assured us that they would remain confidential.
The deceit seems quaint now.
"For starters, it occurs to me to wonder about confidentiality issues. If the provider of a genetic test is not himself a certified medical practitioner, for example, does that mean that the genetic information is not legally covered by patient-doctor confidentiality, since the testee is not the company's "patient" in either a legal or medical sense?"
It seems to me this is a false concern: Genetic testing is not, typically, actually done by one's physician. It's done by third party laboratories, which are simply contractors for the doctor, not in an actual doctor/patient relationship with the person being tested. So, to the extent this issue exists with direct provision of medical testing, it exists already. How can cutting out the middle man INCREASE privacy concerns?
I'll give an example from my own life: I had prostate cancer, I'm now subject to routine PSA tests, quarterly. I have to lose time from work twice a quarter for them: Once to get the blood drawn, and once to have the doctor tell me the number. Where is the sense in this? Why shouldn't I get the PSA test done outside working hours, at a pharmacy, for instance? Why shouldn't the results be phoned to me? Do you think a PSA test is harder to interpret than, say, blood pressure? Or do you think those coin operated blood pressure cuffs should be outlawed?
Yes, the confidentiality issue is a stretch. The AMA did
not write a letter arguing for the right of patients to protect their own DNA data. The AMA wrote a letter demanding that patients be forced to go thru professional gatekeepers to get their DNA tested or sequenced.
Go ahead 5 years and it will become common for babies to get full DNA sequencing at birth. At that point what purpose does this gatekeeper function serve? Parents will have the full sequence for their entire baby's life.
Sorry, Randall, but Stephen J writes likes he has no clue about the confidentiality of medical information. Whether or not the testing lab sends the genetic tests through a doctor or not, the information transmitted would be covered under HIPAA which imposes draconian fines and penalties on any involved parties who do not ensure that the confidentiality of the tests is maintained. Of course - and this was the real purpose behind HIPAA - the government insists that it has a "right" to this "confidential" information. Aside from HIPAA issues, the testing company has, in its own best financial interest, an interest in keeping results confidential so that people will not avoid using this service. As a physician, I am opposed to the paternalistic approach of both the AMA and the government in insisting that people go through a middle man (a doctor) for many medical services such as this. This would include pharmaceuticals, lab testing, and many other diagnostic and treatment modalities. The fact is many physicians, particularly primary care physicians more than 5 years out of training, know much less that people think about the current state of the art treatment for many conditions and with the advent of the internet as a source of information (some good and some bad), people have access to information that many doctors are too lazy or too busy to delve into. That's not to say that some people will miseducate themselves, but I'm opposed to some idiot in the government demanding that the government protect me from myself. Let me make find my own facts and make my own decisions rather than have some government licensed babysitter do it for me. After all, the government doesn't insist that a licensed auto mechanic change my oil, so why should they impose what amounts to a monopoly on US citizens when it comes to health care?
"What are people going to do with their genetic information that is going to hurt them?"
-Worry (disproportionately) about getting cancer or some other disease every single day for the rest of their lives.
-Make fairly significant decisions about having children (or not having them), including having permanent sterilization or in extreme cases aborting unborn children, as one example.
-Request or subject themselves to additional unnecessary, expensive, and potentially risky medical testing in an attempt to screen themselves for specific diseases they think their genetic profile increases their risk for.
-Scare the crap out of close blood relations by inappropriately (and/or incorrectly) raising the possiblity of increased genetic disease risk.
-Create evidence of misplaced paternity (that could have all sort of unforeseen consequences).
Note that I am actually a physician and board-certified in laboratory medicine, so I do know a little bit about this. I've actually seen a few of these things happen firsthand, in particular a. and c. in individuals who have had genetic testing done by their oncologist or at their own discretion, and I am familiar with incidents where d and e have happened. I wouldn't at all be surprised to hear about a happening either.
The point is that genetic testing is fraught with all sort of ethical and practical issues, and in many cases interpreting the results probably should be left up to professionals.
In general, individuals are not able to order any lab test they like from any provider they like and interpret the results themselves, and I see genetic testing as effectively analogous. You can make a libertarian argument that perhaps individuals should be able to simply order any medical test they like on anyone (genetic or otherwise) and interpret the results themselves, or pay anyone to do so, but that's a different issue and a different discussion.
>>After all, the government doesn't insist that a licensed auto mechanic change my oil, so why should they impose what amounts to a monopoly on US citizens when it comes to health care?
In many States, there are all sorts of non-licensed medical "professionals" you can visit if you like (massage therapists, acupuncturists, witch doctors, etc). There are also different "levels" of health care professionals who might treat you (eg board certified MDs, trained non board-certified MDs, MDs in training, PAs, nurse practitioners, chiropractors, etc). Who do you want doing your brain surgery?
More to the point, who do you want to decide who should be able to call themselves a "surgeon" and do surgery? Anyone? How about a veterinarian?
Complicating this issue, historically there have been any number of medical quacks happy to prey on individual healthcare ignorance, and if we return to a system of no mandatory regulation of medical professionals (which I suppose is what you're suggesting) they'll be a LOT more of them.
I am a physician and I am outraged by this AMA recommendation. I am not and will never become an AMA member. I emailed Dr Michael Maves of the AMA to let him know my opinion of his opinion and his insular organization. You might want to email him, at
While I agree with you, please don't make the mistake of conflating the AMA with doctors. They represent less than 18% of physicians. As a medical student, I'll never join them in my entire career, and there are many who feel this way. Also, they lost a lot of membership recently for their stance on Obamacare. Basically, the AMA is now just a lobby organization that, while pretending to represent doctors, actually makes most of its money from their government enforced monopoly on medicare pay codes, which all hospitals must use, even if they don't use medicare, since all the insurance companies use the AMA pay codes.
I blame one-dimensional libertarians for their tendency to view all government as the same, when the benefits of a divide-and-conquer strategy seem so manifest. It seems state governments could assert control over these matters and take the "federal" government to court when it tries to interfere. Assertion of control need not be a matter of prohibition; rather, it could be a matter of permissiveness. Perhaps some states can make themselves the go-to states for direct-to-consumer medical tests within their borders, much as Nevada makes itself a haven for far less wholesome practices.