DTC, FDA, regulation, etc.

By Razib Khan | March 12, 2011 2:41 pm

It’s been a few days since my post on the FDA DTC hearings was linked around the blogosphere, and generated some incredibly well informed discussion. There are plenty of reactions, but there are two which I want to point to specifically. First, Mary Carmichael at Wild Type, who takes a stance more in keeping with my own. And second, Mike the Mad Biologist, who tends to be more sympathetic to the idea that regulation of DTC medical results are necessary. Over the past few days I’ve received some feedback from medical professionals too expressing worry about total laissez-faire.

In regards to Mike’s post, I will admit that I am not totally disinclined toward paternalism. I’m not a libertarian, though my sympathies in that direction are often clear. When it comes to major public health issues the wisdom gained by the professionals through experience and the scientific method needs to be determinative in terms of public policy. But I simply do not see the misinformation inadvertently fostered by DTC personal genomics as in the same kind of category as anti-vaccination paranoia or the results from HIV tests. The medical inferences one makes are generally weak to non-existent in effect and relevance. Second, the arguments for paternalism strike me as very weak in the context of other issues in the broader society. We live in a world of fad diets, agricultural subsidies, and esoteric supplements. Mike wonders about the concern about “freedom” when it comes to one’s own genome in light of major violations of civil liberty in our time, but I wonder about the focus on the down sides of DTC personal genomics when there are much bigger health issues looming on the horizon. DTC personal genomics is powerful primarily in the domain of ancestry. The medical relevance is marginal (right now).

Second, there is the bigger issue of health care and medicine in our society. There are background assumptions at work in my argument which I didn’t flesh out. Individuals vary in knowledge and intelligence. My friends who are doctors admit privately that treatment varies a great deal based on how much the patient is willing to, or capable of, being a partner in treatment and diagnosis. The current crop of DTC personal genomics users are generally well educated and motivated. The later crops are going to be barely able to multiply. That’s a problem. How to distinguish the two? Those of us who aren’t stupid, and know as much, or more, in particular details as medical doctors or genetic counselors are a small minority, but we’re obviously loud, motivated, and are willing to become well mobilized. A quick “genetic competency test” perhaps could serve as a filter, dividing the unwashed from the enlightened.

And yet something else looming in the background right now is the way medicine is practiced in the world today is changing, and has to change. I accept the proposition that from Galen to the 20th century medical doctors generally caused more harm than benefit (much of it due to the fact that they spread disease amongst their patients). Modern medicine is exceptional in that it actually works on a biophysical level. But a lot of the “low hanging fruit” has been picked, and due to the nature of medical research much of the “cutting edge consensus” is wrong. Medicine, like many fields, has been subject to information overload, and I’m skeptical of the ability of any human to keep up. The practice of medicine needs to be augmented by computational analytic tools, as well as a deeper understanding of the natural distortions which occur because of the nature of funding and the institutional framework of biomedical research in the United States, which exhibits an unfortunate trend toward careerism. Add on top of it the political, legal, and ethical variables, and medicine is a tangle which is far more than just applied human biology.

Licensing regimes, and the shift of physicians from being shamans and therapists, and surgeons from being butchers, is a product of a particular time and place, to protect patients from frauds as well as safeguard the legitimacy of a nascent profession. In the current discussion about DTC personal genomics the idea of ‘genetic counselors’ has cropped up repeatedly, which makes sense. The treatment of an individual needs to be chopped up into appropriate specialties, already evident in the need for highly specific medical subfields. The professional system which produces M.D.’s will probably have to change to adapt to the times, as motivated patients will (like me) will have access to enough real-time information to understand that doctors are not omniscient, and need a great deal of complementation to maximize the fruit of the most up-to-date research. Are we going to force the software engineers who write the complementary diagnostic AIs to get an M.D.? Concretely, I’d say the marginal return on public health of a more competent and intelligent doctor is going to decrease because of the “cloud” nature of information which you’ll have access to, especially with the rise of movements such as quantified self. Over the long term what we really need to increase human well being are materials scientists and entrepeneurs who produce innovation which drives economic growth, not more encyclopedic physicians, clever quantitative financial engineers, and eloquent lawyers. So there you go, from narrow specific focus to the big picture. I know that many technologists and scientists who have had the same visceral reaction have some of the same  implicit presuppositions about the nature of progress and the way to maximize human well being. Some have characterized my previous post a call to “war.” But my impulse was driven by the perception that this is just one battle in the never ending struggle to keep the Malthusian world at bay through gains in economic productivity and efficiency.

MORE ABOUT: Personal genomics

Comments (17)

  1. Bhetti

    As a medical student in the profession in the UK and having witnessed healthcare from many angles, I don’t fully trust doctors to make decisions that are in my best interests, nor necessarily the ones that’re informed. They’re human beings with very human personalities. As an aside: The implications are particularly ominous should the UK take the same attitude as the US, given that our healthcare system is fully nationalised (which naturally engenders doctors who are less patient-choice oriented).

    Genetic information about ourselves should be freely available. Its our responsibility as free-willed individuals with capacity to make our own decisions whilst seeking out appropriate information to make them. Basically if we come to any harm conceivably because we did not consult a doctor, that’s our problem. That a doctor would know anything useful we couldn’t find out ourselves is questionable.

    That the companies themselves might be subject to minimal ethical truth-telling regulations is reasonable, though how enforceable or feasible any restrictions on this field might make this irrelevant.

  2. Quite frankly, I trust the software more than my doctor, or indeed any doctor. We’re not talking about surgery here, we’re talking about low-confidence health risks and possible drug interactions. The pharmacist already depends on the software.

    Now if I could get robots who I could be sure would really wash their hands before they touched me, I’d trust them more than doctors and nurses, too.

  3. Razib,
    According to Dan Vorhaus, the FDA has re-opened its period for comments and is also scheduling town hall meetings on this topic. Since you seem to the #1 link hub for this issue, you might want to devote a whole new post to these new opportunities for input.

  4. Updated list of FDA and Congressional mailing addresses, links, etc:


  5. You probably forgot an “http://” in your link to Mike.

  6. MB

    I have come late to this discussion but I like your blog post very much.

    I am wondering if there has been much discussion of DTC as a resource allocation issue? I came to bioinformatics with a background in managed care. My (admittedly somewhat knee jerk) reaction to data I saw it that it appears that physicians are becoming involved in the process whether they like it or not because patients are coming to them after they get the tests to ask them questions about their results. This is leading to some additional testing too. And that requires some spending of health care dollars to pay for that. That might be a big expense or a trivial expense. I don’t know if there is enough data yet to figure that out.

    If I were still in managed care, I would see this as a spending health care dollars on something without strong evidence that it improves patient health. That in itself is something I would consider a negative outcome, completely outside of any possibility of error or misinterpretation.

    I expect that the AMA is seeing DTC in this light. Increasingly, the physician role in the U.S. is to both provide care but also be a financial gatekeeper who rations care so that money is prioritized. Americans don’t like that, but that is the reality.

    I can think of several reasons why I would expect that regulation would be a more conservative approach financially. It would, for example, give physicians the option to always recommend the same company for the tests. Using the same company is cheaper because a physician can read the results more quickly without spending the time to educate himself on what the test means, and that also reduces errors.

    It appears that physician education is going to be necessary under regulation or not. I expect regulation would shift the cost burden of physician education ont0 the DTCs. If a DTC wanted their test to be “prescribed” they would have to spend money on marketing their tests to the physicians, which would include education (like the model of pharmaceutical drug reps).

    The physician could also, of course, talk the patient out of getting the tests in the first place.

    But that’s just an off the cuff analysis. I think it would be quite hard to work out a reasonable projection on that given that most variables are unknown, and you’d have to see how well the insurance companies could manage coverage of these expenses. Sometimes it’s cost-effective for them to provide coverage of things that don’t improve health – like gym memberships – because it attracts healthy patients. That can actually lower rates on some plans, though not overall health spending. Though I suspect covering DTC would attract every hypochondriac in town.

    Anyway, sorry this is so long and full of speculation but I’d be interested to hear your thoughts.

  7. omar

    Its a bit of a stretch to say that the AMA is interested in limiting costs or that regulation is intended to limit costs.
    The AMA may even be interested in increasing costs insofar as those costs consist of payments to doctors in private practice (still the AMA’s main member base). It is interested in limiting costs where those are paid to other professionals and interest groups, not doctors.
    Some people in the AMA may indeed by interested in cost control because they are taking the long view and realize that uncontrolled inflation of medical costs will rebound on doctors when cost-cutting is done in response to fiscal emergency. But even then, the AMA is not likely to focus on physician costs. All of this is to be expected. Bankers cartels are not interested in cutting financial industry profits, why should the doctor’s “union” be interested in cutting physician profits?
    The rational way to limit healthcare costs would be to do one of two things: either national healthcare with a single payor system. OR complete free market. Neither option has too much support legislative support right now. But yes, in a National healthcare system, testing may indeed be regulated to limit costs. And in a completely free-market system, it will naturally be left unregulated. In the present hodge-podge system, regulation of testing will generally increase costs (and is frequently intended as a way of creating new costs..it is not even intended as a cost-cutting system). FDA regulation is not generally a way to ration care (even surreptitiously)..though such regulation may be attempted within managed care organizations or by state and national payors.

  8. MB

    -Some people in the AMA may indeed by interested in cost control because they are taking the long view and realize that uncontrolled inflation of medical costs will rebound on doctors when cost-cutting is done in response to fiscal emergency.

    I think the rebound you are describing already happened when managed care came in, Omar.

    I don’t know how much people know about this, so forgive me if I am stating the obvious:

    Some primary care doctors have contracts where they are paid a fixed amount to care for each patients and then all of the costs that the patient incurs during the year come out of that pot. So, for instance, a doctor might get $2000 if you sign up with him as your PCP for the year and then if you incur $300 in medical expenses it comes out of that $2000 pot. So if you have a DTC test that leads you to think you need a $300 follow up test, he will lose $300 if he lets you have that test.

    The system is supposed to work where the doctor would say no if the test is not medically necessary. In practice, doctors hate doing this. So they are left in a difficult spot, where they either take a financial hit or they have to upset a patient. I can see where a doc would be mad if this was occurring because the patient took a DTC test from a for profit company, and it is not particularly medically useful.

    Not every contract works as directly as this, but I think that under managed care most contracts have some sort of financial incentive where the doctor has to control costs.

    For the AMA, I think, if they can avoid this situation by complaining about safety then that is a better place to fight the cost battle than in the doctor’s office.

    I am not as cynical as you are about doctor’s motivations, though. I did not find that doctors were particularly motivated by money. If they were, I think we would have done better on our contracts.

    Also, I think we do have a moral obligation to keep insurance rates down. When rich people have tests they don’t need, insurance rates go up and then poor people can’t afford insurance.

    This is about where I used to work. I don’t know if you’re interested in risk contracting but it explains some of this better than I did:


    I think the comments referred to us as sleazy bean counters. Meh. No one wants to be told they can’t have stuff.

  9. Alan Redd

    I have concerns with respect to MDs paternal control of my genetic information. The majority of them do not understand genetics and statistics; I don’t believe that MDs get proper training in genetics, and statistics. Many MDs are not curious–they have not been trained to think like scientific researchers (although there are MD PhDs who have better training).

    Have you ever had an MD interpret the basic blood-work tests that you get at a physical? MDs generally ignore them, unless you are about to lose your liver (even then you will not get an interpretation). Have you ever visited an MD and given them a scientific paper? Many MDs don’t read the science. Have you ever asked an MD about the toxicological side effects of the drugs they prescribe? MDs prescribe pills and they often don’t understand how they damage people or how to fix people when they are damaged.

    I believe the ~fourth leading cause of death in this country is from prescription medicines. Read the book “Bitter Pills: inside the hazardous world of legal drugs” by Stephen Fried—you might be terrified, appropriately, when you swallow the pills prescribed by your MDs. http://www.stephenfried.com/bitter-pills/bitterpillsbook.html. We need to focus the conversation on the lack of safety from this system not from DTC.

    What if DTC told us why some people die and suffer from pills MDs prescribe? This would cut into the profits of the drug industry. MDs would lose authority and law suits. The FDA is a pawn of the drug industry–much of the FDA budget comes straight from industry. Some FDA personnel worked in industry. Many MDs get money from industry (http://projects.propublica.org/docdollars/). Is this FDA panel a pawn of the AMA or of the drug industry or both? Is this “regulation” or is it a money grab? It is not about safety, in my opinion.

    Has anyone researched the disclosures of the people pushing this?

  10. omar

    MB, what you say about managed care is true, but if a PATIENT goes and gets a test on his own, that is not coming out of the managed care pot. It would come out of the managed care pot if the doctor ordered it and the HMO paid for it.
    About doctors and money, well, they are no more money-minded that most other professions, but keep in mind that it is very easy to believe something when your income depends on it (and vice versa). We, as humans, are not good judges of when we may be fooling ourselves.

  11. MB

    Yeah, I’m not being clear. Sorry.

    I am not talking about the cost of the DTC tests. Those are paid out of pocket by the consumer. I am talking about the other costs generated when a person gets a DTC test.

    If you look here, in the Kauffman data there seems to be some other costs associated with the DTC tests:


    “Three in 10 study participants indicated that they had shared their results with a doctor or had gotten a follow-up test, and another 18% said that they intended to do so at a future date.”

    So I am talking about the costs of 1) The time spent between the doctor and the patient to discuss that test and 2) the cost of the follow-up tests.

    I don’t know where that money is coming from but I suspect it is coming out of the managed care pool. I don’t know how much it is either. If it’s a once in a lifetime expense it might be trivial.

    But if it’s coming out of the managed care pool it’s coming out of the physician’s pocket and they’re not going to like that.

  12. MB

    Sorry, part of that is going to be totally confusing too.

    The contracts are really convoluted and the primary care physician often doesn’t really make much money off of seeing his own patients because he’s paid a fixed amount for each patient. That’s why 1) is often an expense for the physician rather than income.

    It might be income, it depends on the contract.

    Sorry, it’s very complicated!!!


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About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at http://www.razib.com


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