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Where Are We Going?

Where is it all headed? Medicine on another threshold. Allow me to present several previously unconnected news articles that illuminate the serious problem we face in today’s increasingly scientifically rootless world.

Who are scientific medicine’s friends; on whom can we rely for support of reason and common sense, unbiased approaches to funding, unbiased efficacy evaluation, fair law enforcement, and a return to the logical world of decades ago? The private insurance industry is taking it in the gut, while Pharma receives the repeated jabs. Corrupt administrations run off with hundreds of millions, inadequately punished for the degree of misbehavior. Academicians, no longer squeaky clean, unwilling to keep house on big-money grant recipients while tolerating massive private consulting fees. Schools infiltrated by mindless relativism satisfy the lowest academic levels despite the revolutionary changes in biology and massive knowledge base new MDs have to apply.

Just in 2 weeks a number of seemingly unrelated developments in the news got one to thinkin’, …there aren’t any to trust anymore. The government agencies are just as bad. Start with the FDA. Steve Barrett’s Consumer Health Digest Quackwatch.com has been trying to reassess the status of one or more quackery proponents and practitioners. One of his routes is the examination of FDA records of enforcement and warning letters to violators. From CHD of 3/11/08:

FDA “hides” old warning letters. The FDA Web site has made several changes that greatly decrease the visibility of warning letters about products and safety violations. Letters issued before January 2007 have been moved into a new directory so that all incoming links to them from other sites have been broken. This directory is also coded so that search engines cannot index its contents. Searching for warning letters on the FDA site is difficult because (a) the newer and older letters have to be searched separately, (b) the search page for pre-2007 pages in not easy to find. (c) letters are moved to the archive folder at irregular intervals, and (d) many of the older letters are in PDF format, which means that they will be found only if the searcher uses specific keywords. The agency as become extremely slow in responding to Freedom of Information Act requests. In August 2005, Dr. Barrett asked for a document related to a warning letter. If one exists, finding it would take only a few minutes. Barrett’s Congressman has asked twice for the document, and FDA staff members have phoned Barrett four times during the past year to find out whether he still wants it. But it still has not come. Bloomberg News has reported that in May 2007, the agency had 20,365 unfilled requests, including 1,924 that were more than three years old and that the the number of workers filling requests has been cut even though the backlog had been steadily rising. [Blum J.
It took Steve Barrett a year to get his requested information. Is this under-funding, incompetence, or intentional indifference to public exposure of misdeeds? FDA people have complained of under-funding and staffing since the DSHEA Act of 1994. Sen. Hatch maintains FDA has enough. The system seems poorly organized – to say the least. Last week I received this article from the AHIP Solutions SmartBrief , a health insurance industry newsletter, titled 
Senate seeks $375 million more for FDA:

The Senate passed a budget resolution Friday that includes an additional $375 million for the FDA ‘to close the glaring gaps in food and drug safety,’ said Sen. Edward Kennedy, D-Mass., who pressed for the new funding. The proposed 20% increase might face opposition from critics, including Rep. Rosa DeLauro, D-Conn., who says the FDA “doesn’t have the infrastructure to carry out its mission.

The summary was of this New York Times article. It was more complete and brought in party politics, with a threat of a veto of any bill increasing FDA appropriation. How come? GW may not have any direct interest in the matter, but Senators Hatch and Harkin, who control NIH and FDA funding, certainly do. One can only speculate on the pressures – they do and do not cross party lines. The article also reviewed the proposed stationing of FDA reps in various Chinese cities to monitor the impure and adulterated pharmaceutical precursors originating there (30-50 percent of US products.) How do they plan to monitor or analyze the massive trade in products with 10-20 offices in China?

Then I received this note from Carl Bartecchi, MD of the U. of Colorado about this deal, the request for Federal funding of acupuncture and homeopathy studies on war injuries. It’s getting really bad, said Dr. Bartecchi, who had also seen an article in the Hawaiian paper in August 25, 2002: The article headed: “Pentagon should consider alternative battlefield medicine” by Pat Linton and Dr. Wayne B. Jonas. Dr. Bartecchi reported the article to the former Air Force Surgeon General, who said that he didn’t know anything about it but would look into it. But the matter was apparently dropped.

Jonas, former Director of the National Center for Complementary/ Alternative Medicine and his sponsor, Samueli Institute have already received two separate grants from the Army and Air Force, each for $1 – 2 million. Samueli is the ultra-wealthy “CAM” support foundation funding the UC Irvine “CAM” group and its research. Samuelis are the people who developed the broadband.

The NCCAM and other NIH people have exceeded the $1 billion mark for research, now fund school training programs also, as their former employees are feeding and sucking from every government supported agency they can, sometimes via “earmarks.”

Then Consumer Health Digest reported on the policy of the American College of Physicians supporting the “Single Payer” proposal for funding all US medical care (other than Medicare and Medicaid.) That would be a Federal administered fund, supposedly privately administered locally. Every month or so I receive requests from ACP national office to write congress people not to REDUCE Medicare allowances for physicians. I have not seen an ACP attempt to reconcile these two opposing policies. Government plans have been compared to lobster traps – easy in, but hard to get out of. Ever see a tax supported plan that was not controlled by some governmental force?

As bad as the present private insurance system is, with lax laws and worse enforcement, does anyone around have experience dealing with the two Federal Medical systems now in place? Is any physician truly satisfied? Private docs out here do not see Medicaid patients and have left the Medicare system by hundreds to thousands. Reimbursement is below expense for Medicaid and barely equal to expense for Medi-Care. Raise hands those who can see a Federally funded single payer plan working better than the British, Canadian, or US Fed systems. Could it work if the system were as under-funded as much as FDA with equivalent lax enforcement of rip-off artists?

And finally, pseudoscience medicine will at last meet rational medicine on the field of economics as all players will be treated as professional equals, and “alternative” methods will be reimbursed while “cost-ineffective” scientific methods will not be because there is a voting bloc for the former.

Rational scientific physicians, as hard as it will be to find them, will no longer be in charge. It’s happened already in EBM, as physiology and rationality have given way to RCTs, and their reviews as Kim Atwood has pointed out. And it is happening in med school faculties and teaching, as we all have noted. Anyone got a solution (greater than 60X?)

WS

Posted in: Politics and Regulation, Science and Medicine, Vaccines

Leave a Comment (28) ↓

28 thoughts on “Where Are We Going?

  1. james gaulte says:

    On the other hand, EMRs, quality team work and the ACP’s ( in partnership with United Health Group) “medical Home” will fix pretty much everything under the benevolent wing of a federally managed single payer.

  2. Harriet Hall says:

    As a retired Air Force physician, I’d like to go on record as sayiing I am appalled and ashamed of the organization I belonged to for 20 years. It is hard to even believe that the USAF now has a CAM consultant to the Surgeon General, is supporting the teaching of acupuncture to its physicians, and is considering acupuncture for use on the battlefield.

    I used to know the current Air Force Surgeon General: we were stationed together at F. E. Warren Air Force Base in Wyoming in the early 80s. He had a discarded, non-functioning blood pressure machine that he would pump up (nothing would happen) and he would say “I just tested that on my give-a-shit meter and it registered zero.” Apparently he has applied the same test to the question of scientific rigor.

  3. apteryx says:

    Will you be more outraged if they use acupuncture in military hospitals and it doesn’t relieve soldiers’ pain … or if it DOES?

  4. apteryx – clearly you just don’t understand what we are all about, which means you are not paying attention.

    What is outrageous is using a medical modality that has extremely low plausibility and that the evidence strongly shows does not work. What is worse is what this says about the system – decisions are being made not based upon the science but on ideology and politics.

    To suggest, as your question blatantly does, that we are defending an ideology and are immune to evidence is itself outrageous, given how painstakingly we have publicly documented our position.

  5. Harriet Hall says:

    It WILL relieve the soldiers’ pain. So will any quack remedy and any placebo. We can predict about a 35% placebo response from any ineffective treatment. Placebos are unethical. And they are nowhere near as effective as real pain meds.

  6. apteryx says:

    Steven – I don’t doubt that you sincerely believe acupuncture “can’t work,” but it is not quite true to say that the evidence “strongly shows” it does not, since there are many studies in its favor.

    Harriet – Not all placebos are created equal. A sugar pill labeled “aspirin” will provide a certain limited amount of placebo pain relief. The strength of the placebo effect will depend on the details of treatment. It’s not just “35% no matter what.” An identical aspirin tablet will provide a similar amount of placebo pain relief plus biochemical pain relief, so it will be superior. If acupuncture is “only a placebo,” yet provides impressive relief of certain symptoms in both clinical studies and real life, it may be an above-average placebo. Supposing that acupuncture (“purely placebo”) relieved a patient’s chronic pain just as well as taking an aspirin (placebo plus chemistry), how could the former be unethical and the latter not so, based solely upon their different mechanisms of action? In fact, you could argue that since the placebo effect does not cause bleeding ulcers, it would be unethical not to prefer the acupuncture. If the patient experiences pain relief, why should he care exactly which neurotransmitters are responsible for it?

    (Yes, that presupposes that the acupuncture will provide relief. Maybe it will not, and then patients as well as doctors will not take long to reject it. Your paradigm will only be threatened if people like the results well enough to keep using it.)

  7. BlazingDragon says:

    Why the dissing of a federalized health plan? Want to keep wasting 20% of costs on administration, instead of about 5%? We have no use for the other 15% of the money (except for profit, of course).

    The problems you refer to about federalized health care refer to incompetent administration of the plan, not an inherent flaw in the plan itself. A system where a lot of money is needed for profit and people are given a financial incentive to NOT run tests is no better, and may be worse. Please argue for or against federalized health care on the merits, not on cheap, stupid, and incorrect attacks.

    Check out Ezra Klein’s blog (http://www.prospect.org/csnc/blogs/ezraklein) if you want real arguments for some sort of national healthcare plan.

  8. daedalus2u says:

    The experience is not that useless treatments are quickly rejected. The experience is that they are retained so long as the quacks continue to profit from them. Many quacks don’t even do follow up. They have no idea if their treatments are actually working or not, and presumably don’t care. So long as the military pays for placebo treatments of pain, there will be no shortage of quacks willing to provide it.

    Battle field injuries are not (usually) treated with aspirin but with opiates. In any trial, opiates will work hands down better than placebos. In the appropriate dose, opiates will relieve pain in virtually all patients.

    Acupuncture won’t relieve pain as effectively as opiates. You can make up a fantasy hypothetical, but that is just a fantasy. There are safe and extremely effective meds capable of relieving pain. What exactly is the reason to substitute acupuncture? Other than lobbying by acupuncture and CAM advocates?

    I recently looked at the Declaration of Helsinki, the rules that govern all human experimentation. Use of acupuncture in the relief of battle field pain has to be looked at as experimental. Is the battle field the best place to do research like this?

    http://www.wma.net/e/policy/b3.htm

    It is really quite shameful that experimenting on injured soldiers like this is being considered. People injured on the battlefield do exhibit a stronger placebo effect than people with similar civilian injuries. This is one of the first places where the placebo effect was first noticed. It too much less opiates to treat pain in survivors of battlefield injuries than in civilians with similar severity trauma. The explanation was that simply surviving the battle was such a relief that pain was not a big deal.

  9. apteryx says:

    The military’s interest in CAM has been distorted to give the impression that a soldier who is lying in the street with his leg just blown off is going to be getting acupuncture instead of opiates. Wholly false. He will and should get opiates (fine drugs developed through ethnobotanical knowledge), as should civilian victims of severe pain, who are often denied similar treatment.

    However, the VA treats many veterans who have chronic pain, either from injuries or physical stresses of their military service, or from conditions that may or may not be related to their service history, such as arthritis. These people are not likely to be prescribed opiates for their entire lives. Multiple trials have shown, for example, that acupuncture relieves arthritic knee pain. There are also promising reports of use of acupuncture to treat phantom limb pain, in case reports providing enough relief to enable a patient to wear a prosthesis. The military cares about one thing: whether something works. They don’t care how it works, or whether you believe it should work, or whether you are offended by how you believe it works. Good for them.

  10. mjranum says:

    apteryx writes:
    I don’t doubt that you sincerely believe acupuncture “can’t work,” but it is not quite true to say that the evidence “strongly shows” it does not, since there are many studies in its favor.

    Then you’re either ignorant or you’re being intellectually dishonest.

    What many studies have shown is that the effectiveness of accupuncture is equal to the effectiveness of a placebo.

    That’s another way of saying “it doesn’t work.” Now – either you know that and were choosing your words carefully – which makes you a liar by omission, or you don’t. Which would make you just another ignoramus. Either way, that’s gotta suck.

    mjr.

  11. mjranum says:

    apteryx writes:
    Multiple trials have shown, for example, that acupuncture relieves arthritic knee pain. There are also promising reports of use of acupuncture to treat phantom limb pain, in case reports providing enough relief to enable a patient to wear a prosthesis.

    That’s not the same thing as showing that accupuncture “works.” To show that accupuncture works, you’d need studies showing that it is more effective than a placebo – or prayer – or fake accupuncture.

    Again, placebos and prayer probably help treat phantom limb pain – but there is a difference between “help” and “works.” What’s scandalous is that there are real scientists actually working to really solve the problems of phantom limb pain (and making progress) while people waste their time on voodoo like accupuncture. By the way, if you’re interested in phantom limb pain, you might find Vilayanur Ramachandran’s TED talk as fascinating and inspirational as I do:
    http://www.ted.com/index.php/talks/view/id/184

    I was recently stuck in an airport departure lounge near some suckers who had just made a pilgrimage to Lourdes and were all fired up about the amazing healing they felt. I nearly died trying to stifle my laughter when the lady who had just been talking about how much better her hips felt had to call for special boarding with a wheelchair because she couldn’t walk…

    You’re blatting about what is, basically, faith-healing and it’s the 21st century. It’s ultra-credulous mindsets like yours that we must overcome.

  12. drval says:

    As the US population ages, and the costs of caring for our citizens skyrocket, it seems to me that whomever the payers are (government, health insurers, patients), they’ll need to apply scarce resources to treatments that actually work. We can’t afford to waste time and money on woo, and if the Pay for Performance movement has its way, all the more motivation to direct patients to effective therapies. Is there no hope, Dr. Sampson, for truth to trump snake oil? Perhaps unscientific therapies are the fat that will be lost during the upcoming lean times?

  13. Harriet Hall says:

    apteryx said, “Your paradigm will only be threatened if people like the results well enough to keep using it.”

    How did apteryx get such a distorted idea of what our paradigm is? Anyone who has been reading this blog knows that our paradigm is the scientific paradigm and that we will gladly follow good evidence wherever it leads.

    If there were good evidence for acupuncture, I’d support it and I’d use it myself. There isn’t. All the evidence to date is compatible with the hypothesis that acupuncture is nothing but an elaborate plalcebo system. Read Bausell’s Snake Oil Science.

  14. Ted Powell says:

    “…people waste their time on voodoo like accupuncture.”
    Ummm… In voodoo, isn’t sticking in pins supposed to have the opposite (i.e. harmful) effect?
    (Sorry, couldn’t resist it.)

  15. pmoran says:

    “To suggest, as your question blatantly does, that we are defending an ideology and are immune to evidence is itself outrageous, given how painstakingly we have publicly documented our position.”

    I think I understand what Apteryx means. There are “givens” in the usual skeptical position which are never challenged and biases that we are reluctant to acknowledge.

    This blog has so far mainly supplied evidence that the SBM “gold standard” of the RCT often works rather indifferently in practice to separate “effective” from “ineffective” methods. This applies whether they are conventional or CAM. RCTs seem to only work in the long run for the mainstream because of the sheer volume of clinical study.

    So how are we to draw any line with “alternatives”? The standard we hoped to apply has collapsed on us, and we don’t think most of them are worthy of research resources anyway. I suggest that there is no chance in Hades of selling to a scientifically unconcerned public the idea that if you want to know what medicines are worth using, go and ask a skeptic. Yet that is essentially what you are asking of them when you want to emphasise plausibility. It may be correct logically and scientifically and worth exploring as another facet of science, but it revolves around the same kind of arguments that have failed to be very influential in debates about “alternatives” in recent decades.

    Worse, we have not yet established what working AS placebo means for medical practice. The science — repeat, the science — shows that placebo has no effect on objective disease states in general, but it definitely does allow the possibility of worthwhile symptomatic benefits, with small-to-moderate mean effects being found even in the placebo-unfavourable environment of the typical clinical trial (Hrobjartsson et AL and others).

    It is also plausible that placebo treatments would have quite potent effects under some circumstances, given the known suggestibility of mankind and several possible mechanisms of action. Do we include plausibility in our judgements when it fits in with what we want to believe, but ignore it when it might sway matters the other way?

    Obviously there are purposes for which the use of placebo medicines is ridiculous, such acupuncture on the battle field. That is because it is difficult to think of any situation where there are not obviously better conventional treatments. But what if the Medic has run out of morphine and decides to offer some version of acupuncture for whatever placebo benefits it may offer while awaiting evacuation? It may well not help much, but give me a reason why that should be condemned, especially if evidence of additional endorphin release were confirmed. (I agree that there will be better things to spend resources on — more morphine? )

    We hate it when “alternative” supporters characterise mainstream medicine by our occasional faults and our worst results. Yet we constantly try to exploit the dangerous and ridiculous extremes of “alternative” belief and practice to prop up what may yet prove to be a hopelessly quixotic crusade against the very existence of such methods. And it doesn’t seem to be working. We might as well just make sure that what information we have is available and wait for the pendulum to swing back naturally, as it will one day.

    I accept that CAM is mostly unscientific crap (except for some herbs, but even they need work), but we have not yet excluded the possibility that these placebo medicines are helping people cope with some kinds of condition, mostly ones where the doctor’s evidence-based cupboard is rather bare, already emptied out, or considered too powerful or risky for the job. Who are we to begrudge this?

    The sky-is-falling atmosphere of some recent posts also hints that science is such a fragile human endeavour that it may collapse if prescientific nonsense is permitted to sit alongside it. That is another rather extreme view. Again, the *scientific* evidence is that nearly all the “alternative”-using public also use conventional methods. This suggests some level of discrimination and good sense even in these good folk. The assumption that nearly everyone else is gullible or stupid and needs firm guidance about alternatives is wrong. That is our observational bias — we skeptics are so sensitive to and so much more commonly exposed to the extremes of CAM as to not be prepared to see any good in it ever, at all, under any cricumstances. That is what Apteryx may be alluding to.

    I think our message may be slanted towards the wrong aspects of the science, those bits that interest and concern us, while the people we wish to influence are chewing their legs off to get away from lengthy expositions that they can scarcely follow. We should make up our minds about the placebo and, if appropriate, give credit where credit is due –i.e. allowing that placebo medicines may have their place at least by patient choice at this point in the evolution of medicine and society, but strongly emphasising that they should not be relied upon as the sole answer to major illnesses. That message may be simpler and easier to sell than outright rejection and is as consistent with the facts as anything so far presented here.

    Note that I am not necessarily promoting the conscious use of placebos by medicos as a matter of policy, so please do not go off on that tangent. I am trying to understand why things have worked out the way they have and how we can best limit the *medical* harm that CAM can undoubtedly do. The science will look after itself, in my view.

    But I am prepared to be persuaded otherwise.

  16. Harriet Hall says:

    Pmoran makes an excellent point. I have no objection to using any unproven treatment as long as it doesn’t endanger the patient’s health. What I object to is misrepresenting the science.

    If you say acupuncture is definitely proven to work by good science, you’re lying.

    If you say acupuncture is not supported by convincing scientific evidence, but some people have thought it helped them, that is honest and leaves the door open for patients to try it if they so choose – and to get the potential placebo effect without alienating them or driving them away from conventional medicine.

    I don’t think it is ethical to prescribe unproven treatments, but it is ethical to support your patients who choose to use them.

  17. David Gorski says:

    The military’s interest in CAM has been distorted to give the impression that a soldier who is lying in the street with his leg just blown off is going to be getting acupuncture instead of opiates. Wholly false. He will and should get opiates (fine drugs developed through ethnobotanical knowledge), as should civilian victims of severe pain, who are often denied similar treatment.

    If that’s the case, then why did Col. Niemtzow dub his brand of acupuncture “battlefield acupuncture“? That’s either really dumb marketing, or he intends that it be used on the battlefield someday.

  18. qetzal says:

    pmoran commented:

    This blog has so far mainly supplied evidence that the SBM “gold standard” of the RCT often works rather indifferently in practice to separate “effective” from “ineffective” methods. This applies whether they are conventional or CAM. RCTs seem to only work in the long run for the mainstream because of the sheer volume of clinical study.

    So how are we to draw any line with “alternatives”?

    Let’s not forget what else this blog has championed – that scientific considerations can be added to available clinical data to decide whether an ‘alternative’ medicine is at all plausible.

    For instance, it’s plausible to propose that herbal medicines might work. We certainly know lots of phytochemicals that are pharmacologically active.

    In contrast, it’s not plausible to propose that various ‘energy therapies’ like therapeutic touch could be effective. There’s no scientific basis to propose the existence of ‘life energy.’ (Right, pec?). Ditto homeopathy.

    I think that’s an excellent way to draw some very clean lines.

  19. weing says:

    I find it curious that it is unethical for us to prescribe a placebo pill, but OK for CAM quacks to prescribe acupuncture and homeopathic treatments.

  20. apteryx says:

    pmoran wrote:

    “That is our observational bias — we skeptics are so sensitive to and so much more commonly exposed to the extremes of CAM as to not be prepared to see any good in it ever, at all, under any cricumstances. That is what Apteryx may be alluding to.”

    Yep! Once traditional medicine is lumped with homeopathy and crystal healing under “CAM,” I cannot really blame someone who gets on the web, sees a bunch of ads for bogus energy machines and cancer cures, and says “This is all a lot of crap!” However, that’s the same attitude, in reverse, as is held by the person who sees oncologists selling chemo drugs for profit to people dying of cancers not responsive to chemo, and responds by condemning all “allopathy” as a scam. These labels obscure the fact that there’s a broad range of practices in each group, some well validated, some not well validated but probably often effective, some garbage.

    People who take extreme positions deprive themselves of the benefits available to more broad-minded consumers (e.g., Harriet, if you ever have a sore elbow, acupucture might help – but if so, you’ll never know). I just heard a great story from a person who had been working in a health food store and had someone come in saying that he thought he had appendicitis and wanted her to recommend an herb for it, because he didn’t like doctors! (She told him to get in her car and she’d drive him to the hospital.)

  21. Skeptical Cat says:

    Harriet, if you ever have a sore elbow, acupucture might help – but if so, you’ll never know

    But the thing is apteryx, that even if you go get some acupuncture and even if you feel better afterwords, you still do not know whether or not it works.

    Medicine is not something that can be decided at the level of the individual consumer.

  22. apteryx says:

    Do you mean to say that individual consumers shouldn’t be able to make their own decisions? Or just that an individual consumer can’t by his own experience alone determine “whether or not something works” via biochemical mechanisms? I’ll completely agree with the latter. But that inevitable ignorance would not stop me from purchasing either a Western medical treatment or acupuncture. Clinical trials, along with the experience of many other human beings, show that acupuncture relieves a number of painful conditions. I do not care whether it’s a neurologically active treatment, or a super-placebo. All I care about is that my pain is relieved. What’s so wrong with that?

  23. pmoran says:

    Apteryx ; ” Yep! Once traditional medicine is lumped with homeopathy and crystal healing under “CAM,” I cannot really blame someone who gets on the web, sees a bunch of ads for bogus energy machines and cancer cures, and says “This is all a lot of crap!” However, that’s the same attitude, in reverse, as is held by the person who sees oncologists selling chemo drugs for profit to people dying of cancers not responsive to chemo, and responds by condemning all “allopathy” as a scam. These labels obscure the fact that there’s a broad range of practices in each group, some well validated, some not well validated but probably often effective, some garbage. ”

    Yes there is such an overlap, although I think you and I would disagree as to how many and which alternative methods are well validated as working “better than placebo” (something that should ALWAYS be specified if that is what we mean, when we use the word “works”).

    Remember that homeopathy has quite a few positive studies, but I believe they are due to the static and artefact that plagues clinical studies especially with subjective complaints . This is a special problem with theatrical and difficult-to-blind methods such as acupuncture, which you seem to favour. Acupuncture studies could easily be influenced by a little off-handedness when sham acupuncture is applied, or an unguarded “that will make you better” when real acupuncture is performed.

    Acupuncture repels the skeptic because of its associations with Chinese superstitions and the extreme implausibility of the proposition that needles at special spots in the body is going to have unique “healing” power. Yet its inevitable placebo activity may be supplemented by the enforced relaxation while the treatment is applied and counterriitant amd distractant activity. We should go for the most economical explanation of its popularity.

  24. daedalus2u says:

    apteryx makes a valid point, if all he wants is pain relief, then if treatment xyz relieves his pain, he doesn’t care what the mechanism is. Which treatment to choose depends on the individual’s trade-off of therapeutic effects vs. side effects.

    Side effects are not only physical but can be psychological. Some people choose to reject EBM because it conflicts with their religious belief that disease is caused by evil spirits, sin and lack of following the correct religious practices. For such people, EBM has the potential side effect (if it does work), of damaging their faith. Such people may decide they would rather be sick in their delusional world than well with their delusions shattered.

    Some people try to cover both bases and use both EBM and woo. They get to maintain their belief in woo while getting the benefits of EBM. They can then deceive themselves that it was really the woo that cured them, or that the EBM actually works via the mechanisms they ascribe to woo.

    It is not unreasonable that skeptics would not want to try non-science based treatments. The only known mechanism is via the placebo effect and even if they do have effects mediated through the placebo effect, the placebo effect is best “saved” for when it is really needed and used additively with EBM based treatments, not wasted by being used by itself.

    I think the potential for psychological side effects has not been much thought of by EBM and CAM practitioners. If the theoretical explanation is non-physiologic and not reality based, and if the treatment “works”, then the patient has the risk of adopting that non-physiologic non-reality based world view. This is one of the risks that all CAM based treatments should have to disclose to those being treated by those CAM based treatments. That there is no generally accepted theoretical explanation consistent with physiology that provides a basis for why this treatment would work, and that if it does work the patient has the risk of believing in non-physiologic and non-reality based treatments.

    If a proposed treatment doesn’t have a known basis in physiology that is known to be common in humans, then any attempt to use it really as to be thought of as experimental. Any successful outcome must be thought of as an anecdote. If I am sick and need some treatment, I really don’t want to do an experiment with an n of 1 on myself. I would like to try something that has a basis in physiology or has been shown to work in RCTs.

    There are an infinite number of potential treatments that have no basis in physiology known to be common in humans. Plenty of them are “scientific sounding” yet have no basis in physiology, the use of stem cells to treat autism for example. There is no evidence that autism is caused by a lack of stem cells any where and no evidence to suggest that stem cells have the possibility to improve it.

    The use of chemotherapy on cancers that are known to be unresponsive to chemotherapy is the same as any other treatment that has no basis in physiology. It is just as much quackery as is homeopathy.
    As I see it there are only two methods for obtaining science based medical treatments.

    1. Known physiology via known mechanisms, known to be important in humans.

    2. Unknown physiology but shown to work in well run RCTs.

    Most surgical treatments are probably #1. Surgically removing a tumor has known physiology behind it. Exercise, proper diet, stress reduction are too. Any unique case can only be treated based on physiological principles that are not unique. Most psychopharmacology is #2. The mechanisms are mostly unknown.

    One way to deal with CAM is to cut off its funding. Insurance doesn’t pay for “experimental” treatments. If a treatment isn’t based on known physiology, or doesn’t have RCTs behind it, then it is “experimental.” Experimental subjects are not expected to pay for being experimented on, and the Declaration of Helsinki requires that humans that are the subjects of experiments to be treated a certain way. The Declaration of Helsinki reflects the “standard of care” by all medical professionals all over the world. It isn’t just an FDA viewpoint.

  25. pmoran says:

    There are ways of reconciling Apteryx’s “the customer is always right” viewpoint with the skeptic’s insistence that personal medical experiences are a poor guide to the intrinsic worth of medical treatments. One is talking apples and the other oranges.

    One aspect is the rarely considered point that in medical science adequacy of evidence always carries with it an unspoken “for this particular practical purpose”. In the absence of other evidence as to which treatments have intrinsic efficacy, or the sophistication needed to evaluate what evidence is available (sometimes still ending up with uncertainty), it is absolutely rational to use a treatment that was associated with a satisfactory outcome last time. What else can you do? It is even rational to try treatments on miniscule evidence if there is nothing known to work better or everything else has been tried. In medicine context is everything and there are millions of possible ones, differing as chalk and cheese.

    Another is to point out that medicine as a profession, and even health care payers, are burdened with overarching responsibilitis that do not apply to individual patients. The patient is thus quite entitled to use dubious treatments if at their own expense and risk and no one can control what beliefs they may then personally attach to them. But, as Harriet has recently pointed out, they should be prepared for an argument if they then proceed to make unjustified scientific claims and promote treatments to others on insufficient basis.

    Another is to point out that if placebo reactions exist the patient is *always* right in the limited sense that absolutely any kind of therapeutic activity, no matter how weird, is going to be of symptomatic benefit to some patients, even sometimes providing an environment that may help terminate some kinds of illness.

  26. RationalEyes says:

    I disagree with a central tenet of pmoran’s initial comment (#2221).

    pmoran states that it is an extreme view that science “may collapse if prescientific nonsense is permitted to sit alongside it”. My experience as a practicing pediatrician is that the seemingly benign nature of a parent giving her child homeopathy as a “complimentary” treatment for their child’s asthma, or osteopathic manipulations for their ear infections is much more dangerous than it might at first appear. It is not the danger from the actual treatment (although, of course, that is possible in some instances), but it is the irrational, antiscientific thinking underlying the decision making that I am concerned with. It is often these same parents who refuse to vaccinate their children, or who favor some random vaccination schedule they discovered on the internet. These dangerous decisions stem from the same lack of understanding of the scientific method, and of the scientific framework upon which so much of what we as physicians do, as does the use of “placebo-based” CAM therapies. It is this increasingly prevalent use of non-scientific rationales in medical decision making that I fear threatens the practical potential of scientific advancement.

    It may seem harmless to simply acquiesce to the irrational use of CAM therapies by our patients, but the fine line between the use of placebos as complimentary therapies, and dangerous decision making regarding something as important as vaccinations, I fear, has already been crossed.

  27. pmoran says:

    Well, I am not sure that there is any necessary connection between the use of placebo medicines and antivaccination activity, but I must ask you whether it is extraordinarily irrational for the public to be concerned about risks from vaccines? One of the reasons for their concerns is the medical profession’s sometimes lofty dismissal of them. We supply non-transparent ex cathedra pronouncements from in-house bodies saying that “there is no evidence that — ” when what the public wants to see is dlear data showing that populations receiving modern vaccine schedules are not damaged in any way when compared to the non-vaccinated. I know is it not easy to get such data.

    We stretch the trust of a generally risk-averse public whenever we don’t take such concerns very seriously. They suspect that even if there were occasional serious risks from vaccines to some individuals we would still encourage the public to have them.

    Everything you say has some validity. However, if we have indeed already “crossed a line”, it does suggest that what we have been doing so far, interpreted by the public as the intention to deprive them of valued medical options, is not working very well.

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