Respectful Insolence

I’ve lamented time and time again just how much money the National Center for Complementary and Alternative Medicine (NCCAM) wastes on basic research and clinical trials of modalities that are, from a scientific viewpoint, so highly implausible that the chances of finding a clinically useful or relevant–or even a consistent statistically significant–effect (for example, homeopathy or reiki) or on therapies for which there is already abundant negative evidence (chelation therapy, for example) are vanishingly small. In this fifth year of a flat or declining NIH budget and of scientists facing the most unfavorable paylines for getting funded since the early 1990s, it strikes me as utterly irresponsible to be devoting over $120 million a year to mostly badly designed studies to test if woo works.

Sadly, what I didn’t know until fairly recently is that NCCAM isn’t the only source of NIH money going to fund woo. There is in fact an Institute in the NIH that actually spends more money studying woo than NCCAM. Indeed, in FY 2007, it spend $121,932,765 million on CAM-related research, funding 461 projects in the form of grants, cooperative agreements, supplements or contracts, compared to the $121,400,000 spent by NCCAM. Really, it’s true, and its CAM portfolio represents 2.5% of its total budget. So what is this Institute funding lots of “complementary and alternative medicine” (CAM)? Can you guess? I’ll be happy to tell you.

It’s the National Cancer Institute. Alright, I’m sure virtually everybody figured out the answer based on the title of this post, but I had to generate some suspense somehow, didn’t I? In any case, ensconced deeply in the NCI, there is an office known as the Office of Cancer Complementary and Alternative Medicine (OCCAM). Even though I was disappointed to learn this, I nonetheless looked at the highlights of OCCAM-funded research and then at OCCAM’s entire research portfolio for last year, including 151 open clinical trials and 145 closed trials. Although my overall gestalt was that it looked a lot like the usual list of CAM trials funded by NCCAM, there were several trials immediately visible that weren’t obviously CAM trials by their titles, and there were plenty of trials of nutritional supplements or dietary manipulations on cancer development or treatment, showing once again how CAM has somehow managed to appropriate the scientifically legitimate area of nutrition and diet research as somehow being “alternative.” Actually, I don’t mind this sort of research so much, as long as it’s testing hypotheses that are supported by sound basic science and preclinical data. I just resent that somehow such research is now considered “CAM” when nutritional research has long been a major area of “conventional research.” Ditto the study of natural products and herbs with useful pharmacological activity, an area of research in pharmacology since time immemorial. There’s no scientific rationale why such studies should be segregated away as “alternative”; they could and should be evaluated just like any other scientific study, and, even worse, segregating them into the CAM ghetto devalues them and by association with the woo also being funded under the rubric of “CAM” makes them look like woo too.

Unfortunately, there also appears to be a fair amount of woo in the OCCAM portfolio, such as studies of healing touch and reiki–at the Cleveland Clinic, yet!–in cancer patients. Worst of all, OCCAM is funding a trial of homeopathy! This trial happens to be at the Oklahoma University Cancer Institute, which suggests to me that I may have to add OU to my Academic Woo Aggregator at its next (long overdue) update. It’s all very depressing, especially because, as I peruse the list of open trials today and compare it to the list of closed trials, I get the distinct impression that the open trials include more woo, implying to me that OCCAM is getting less scientifically rigorous in what it is willing to fund. On the other hand, somehow in the closed trials are a whole bunch of trials of antineoplastons, a highly improbable and dubious therapy; so maybe my impression is wrong. I must say, however, that my confidence in the scientific rigor of the entire OCCAM enterprise was not boosted by my encounter with an OCCAM representative at the AACR Meeting three weeks ago that I never blogged about. Suffice it to say that he went on about “royal herbs” and couldn’t provide a good rationale why anyone should conclude that impure mixtures of compounds would be more effective or reliable than pharmaceuticals. When he started going on about “emperor” herbs and “assistant” herbs, I couldn’t take it anymore.

Be that as it may, no matter how much money OCCAM throws at CAM studies, CAM advocates are not happy. Oh, no, they’re not happy at all. It’s not enough, you see! Indeed, published at that repository of all medical crankery and quackery, NaturalNews.com, recently appeared an article entitled Analysis: Virtually Zero Alternative Cancer Research Occurring. The article cites an “analysis” done for a non-peer-reviewed newsletter called CancerWire published by Michael Horwin, MA, JD. Now, you’re probably wondering how this analysis can conclude that there is “virtually zero alternative cancer research” going on, given that I just showed hundreds of billions of dollars a year worth of alternative cancer research being funded by OCCAM. Easy. Just complain that it’s not the right kind of CAM research that’s being funded:

The authors found that of the 7,080 clinical trials for cancer currently ongoing, over 3,000 are focused on chemotherapy — a treatment that already has over 50 years of research to its credit with relatively little practical return on investment. Of the remaining trials, over 2,000 were focused on more advanced biological treatments such as anti-angiogenesis drugs, which work to cut off the blood supply to tumors.

In all, only 123 of the trials deal with any type of alternative or complementary treatment. “These 123 represent only 1.7% of the total and included trials of various foods, herbs and modalities such as: soy, ginger, Valerian, Curcumin, acupuncture, Reiki, meditation, garlic, Green tea, and Tai Chi,” the authors state. An optimist might find comfort in the fact that the number at least reached the triple digits, but closer analysis reveals an even less tolerable situation.

“The overwhelming majority of these trials examined questions that did not focus on whether these approaches alone improved survivability from cancer,” the authors report. What this means is that the treatments were actually being evaluated not as treatments, but as adjunctive therapies to improve the rate and intensity of symptoms among those patients already undergoing conventional therapy.

In other words, because the vast majority of these clinical trials did not test alternative therapies alone against cancer to see if they show objective evidence of anti-tumor activity that can lead to tumor shrinkage and measurable increases in survival, Adam Miller is unhappy. Of course there’s a very good reason why these therapies are not being tested alone, and it’s simple ethics. It is highly unethical to perform a trial in which one arm receives a treatment that the investigators doing the study do not have a strong reason to believe to be effective. Indeed, in cancer trials at least, even new drugs that investigators have good reason to anticipate to be effective are usually not tested alone in anything other than phase 1 trials. Instead, usually they are tested in addition to the standard of care or in addition to a known effective treatment regimen. The reason is that many new drugs that have made it through the preclinical gauntlet of basic science experimentation, testing in animal models, and safety testing in phase 1 trials still fail to demonstrate objective evidence of efficacy in phase 2 or phase 3 trials. Consequently, it is considered unethical to expose cancer patients to the risk that the new drug they are taking will turn out to be a dud without a “back up” of getting a treatment known to be effective. Imagine now subjecting one group of cancer patients in a clinical study to various forms of woo without standard of care therapy or even known effective therapy. It’s obvious to me how unethical that would be, and it would be equally obvious to any clinical researcher worth a damn. Moreover, even if the researcher conducting such a study really, really believed that the “alternative” therapy being tested could cure cancer (thus making the trial ethical to him), any Institutional Review Board worth a damn evaluating the study for approval would shoot it down. Finally, did it ever occur to Miller that testing a drug in combination with another known effective drug is looking for an effect over and above that of the effective drug, indicating additivity of the effects of the two drugs and an independent therapeutic effect of the “add-on” drug while making sure that patients in all treatment groups get effective therapy? There’s more to clinical trial design than just the science, but does Miller or Horwin understand that?

Nope.

Of course, it’s very clear where Horwin is coming from by taking a look at his newsletter. He begins lamenting the “conventional” paradigm in cancer treatment, which he characterizes thusly:

Cancer is caused by personal choices, genetics and acts of God. Scientists around the country are making important discoveries that are getting us closer to a cure every day, but more money and research is needed. When it comes, a cure for cancer will come from a large pharmaceutical company. Only a deeply researched expensive drug can cure cancer. Anyone who is serious about alternative or nutrition-based therapies is ill advised, a multi-level marketer, or a quack. Alternative therapies are ineffective, unproven or disproven and a waste of money.

Ah, yes, the typical altie straw man characterization of how scientific medicine approaches cancer. At least Horwin spared us the usual “cut, burn, and poison” refrain about the dreaded “conventional” or “allopathic” medcine that we typically hear from Mike Adams, Whale.to, and their ilk. However he does then next launch into a glowing story about Dr. Andrew Ivy, the doctor who pushed the dubious cancer therapy known as Krebiozen back in the 1950s and 1960s. Basically, Krebiozen was claimed to be a hormone isolated from horse blood, and injections of this concoction were claimed to cause dramatic tumor shrinkages and even remissions. Naturally, Horwin sees the lack of acceptance as “orthodox” medicine “suppressing” a cure, and even goes so far to claim:

Today, Drs. Ivy’s insights may be better appreciated. In the last 20 years, mainstream science may have caught up with the insights of this physician. According to a leading medical treatise, “Animal studies have conclusively shown that the immune system can recognize and eliminate malignant tumors in vivo.”(14) In recent years, billions of dollars have been invested in isolating and synthesizing interleukin, interferon, and other cytokines-all natural immune-related substances which can kill or arrest cancer and that are found in the blood of mammals including horses and man.

What any of this has to do with a dubious substance isolated from horse blood is not explained. What is explained at Quackwatch is just how improbable Dr. Ivy’s claims were and how incompetent and bogus his Foundation’s clinical research was, for example:

In 1962, California physician decided from what he had seen and read that krebiozen research was not a bona fide clinical investigation. He wrote to ask for krebiozen for a patient who had had a bilateral pneumonectomy. Bilateral pneumonectomy (the removal of both lungs) is incompatible with life. No questions were asked, however, and krebiozen was sent with the usual request for $9.50 a vial. When the physician didn’t pay, he received rebillings at monthly intervals. When he reported this to the FDA, further investigation followed.

In March, 1963 another physician wrote deliberately stating his patient had had a bilateral total pneumonectomy, the unambiguous removal of both lungs. This is inconsistent with life and with common sense, but the Krebiozen Research Foundation, whose principal scientific consultant, Dr. Ivy, is a distinguished physiologist, sent 8 ampules of krebiozen and a bill for $76.

And, most tellingly:

Samples of krebiozen were reluctantly provided on two occasions to the National Cancer Institute, and on one occasion to the FDA in the form of dry powder. In September, 1961, the material was labeled as pure krebiozen, and this identification was confirmed and reiterated as late as March, 1963. All three samples, on analysis by the FDA, consultants from several universities, and by studies at the National Cancer Institute proved to be creatine monohydrate, a normal constituent of muscle and a common laboratory compound purchasable for $.30 a gram, approximately $10 for a 1-ounce bottle.

As you might expect, the Krebiozen Research Foundation had an answer for this set of observations, too. They implied that the FDA had misinterpreted the data and overlooked the important facts –that the creatine monohydrate was just a contaminant in what had previously been labeled pure krebiozen, and that trace quantities of real krebiozen were there.

The very fact that Horwin would cite Dr. Ivy as a victim of orthodoxy run amok “suppressing” cures shows that he is credulous in the extreme. This leads him to lament this:

…if one includes Dr. Burzynski’s antineoplaston studies, a total of 27 clinical trials out of 7,080, less than half of one percent are focused on alternative and complementary therapies as a stand alone treatment to assess survival. If one considers the Burzynski trials as a separate category, then only 3 of 7,080 or .04% are focused on this question.

These numbers speak volumes. Alternative therapies represent a small minority of cancer clinical trials and only a smaller number of these are focused on whether they are viable treatments. While there were 3,198 chemotherapy trials, a treatment that has been experimented with for over fifty years, less than 30 trials were focused on natural approaches. This analysis suggests what many observers have been reporting for some time that alternative therapies – stand alone natural cancer treatments have been co-opted into the conventional paradigm. They are no longer seen as potentially powerful treatments in their own right, but rather “add-ons” to ameliorate the side effects or improve the quality of life for patients who receive the toxic conventional treatments.

From my perspective, barring compelling evidence to persuade me otherwise, that is actually entirely appropriate, both scientifically and ethically. Indeed, believe it or not, I find Horwin’s complaint about CAM research in cancer to be somewhat heartening. It suggests to me that the infiltration of woo into the NCI is still fairly low. That doesn’t mean it isn’t troublesome, though. For one thing, the approximately $122 million that the NIH spends a year on CAM research could easily fund 50 to 75 clinical trials or R01 grants studying hypotheses that are based in plausible science and thus far more likely to produce a concrete benefit to cancer patients in terms of improvements in treatment efficacy and/or symptom relief than spending that money on modalities that are at best of dubious plausibility and at worst as improbable as homeopathy. That’s a lot of lost opportunity, but as a total percentage it’s perhaps not as bad as I had feared. Even so, even if the funding as a percentage of total trials by the NCI is small considerable damage to scientific medicine can be done. By funding utterly implausible and not better than placebo modalities like homeopathy, healing touch, and reiki, even if it’s only a handful of trials, the NCI gives such woo as reiki, therapeutic touch, and even homeopathy an undeserved patina of scientific respectability. Worse, it tends to encourage medical schools, which are hurting now as they chase after an ever-shrinking pool of NIH grant money, to chase after CAM dollars by doing such research, perhaps even joining the list of centers of quackademic medicine in my Academic Woo Aggregator.

Comments

  1. #1 Catherina
    May 6, 2008

    You may want to distribute copies of “Trick or Treatment” by Simon Singh and Edzard Ernst amongst the decision makers at NCI, so they get a basic grasp of placebo effects and how to test alternative “medicine”.

    http://www.amazon.co.uk/Trick-Treatment-Alternative-Medicine-Trial/dp/0593061292

  2. #2 Niobe
    May 6, 2008

    OCCAM? That can’t be an unintentional acronym. Is it self referential irony?

  3. #3 madder
    May 6, 2008

    @Niobe:

    OCCAM? That can’t be an unintentional acronym. Is it self referential irony?

    Note that they used the popular misspelling of Ockham’s name. Yes, it’s self-referential irony, but mixed with the utterly appropriate decision to use the popular misconception in place of reality.

  4. #4 Becca
    May 6, 2008

    1) Miller’s quote kinda frightens me- either he has no idea about ethics, or how clinical trials are actually run, or he’s really creepy.
    2) I can understand your frustration, but you seem to basically *define* “complementary and alternative medicine” as woo/hogwash/worthless. If it’s scientifically reasonable, it can’t be an alternative to science right? Well, many things are scientifically reasonable, but are still *alternatives to how we currently treat things*. Most cancer research has not, historically, focused on chemoprevention, but that is a huge buzzword now… and I doubt that would have come about had it not been for the way CAM is viewed.
    I can see why it bugs you this stuff gets millions of dollars (and we are all suffering from the sad state of the decreasing NIH budget), but I wonder if you are really focusing on the *resultsĀ° of this research.
    We’ve already seen one way it might influence cancer research, and I think that’s for the better. Another effect research into CAM might have is that at least some of the people who are desperate to try it will do so in the context of clinical trials- where if there are effects (for good or ill) they are more likely to be noticed. Finally, it really does the public image of scientists good to be able to point to X Y and Z trials and say “well, look, it doesn’t work” than to have us percieved as sticking our fingers in our ears and saying “lalala-can’t hear you… UNSCIENTIFIC!”.

  5. #5 Prometheus
    May 6, 2008

    Becca makes an interesting point, that there is a need to test – even if only to refute – “CAM” treatments for cancer. In an ideal world – where there was unlimited funding for research – it would be reasonable to research all of the popular “CAM” treatments for cancer (or other disorders).

    However, this is not an ideal world and funding is not unlimited. I don’t do cancer research, but I am a potential future “customer” for cancer therapies (as are we all). As such, I would prefer to see the research money and effort directed to treatments that are likely to be effective.

    Granted, this may “cut out” some unlikely treatments that are actually effective, but I doubt that “healing touch”, reiki, antineoplastons and other extremely-low probability modalities will ever be shown to be more effective than placebo. And when I get cancer, I want my treatment to be much better than placebo.

    As for homeopathy – it is placebo! Any money or effort directed toward researching homeopathy – as a treatment for anything – is wasted by definition.

    I think that the focus needs to be shifted from the fringe practitioners who want some “science” to back up what they’re already doing (and won’t stop doing it even if the data shows that it doesn’t work) to the patients (and future patients) who need safe and effective treatments. If you focus on the patients, it makes much more sense to put the research money and effort into those treatments that are most likely to benefit the patients, not the fringe practitioners.

    Prometheus

  6. #6 wfjag
    May 6, 2008

    Prometheus wrote:

    “Becca makes an interesting point, that there is a need to test – even if only to refute – “CAM” treatments for cancer.”

    The trouble with that, is that you’d have to try a CAM treatment alone, or several CAM treatments together, while forgoing conventional treatments that have established track records. That’s very similar to what was done in the Tuskegee syphilis study. Although there weren’t effective treatments for syphilis in some of its stages when the study began, by 1972 when the study was terminated, treatments had been developed over the years, but not provided to the subjects. Reputable researchers don’t engage in that type of human experimentation.

    That’s one of the problems, Prometheus, that being ethical causes you. Now, if the particular types of cancers that the CAM proponents proclaim that their various treatments will cure could be induced in those proponents, I guess we could ask those proponents for volunteers for CAM only treatment studies.

  7. #7 Orac
    May 6, 2008

    Prometheus nailed it. It’s a matter of prioritization. I’m not at all opposed to testing improbable claims scientifically, but with limited research dollars we must prioritize better which ones get tested first. When it comes to developing better medical treatments, hypotheses and therapies that are based on very, very improbable scientific “theory” and thus incredibly unlikely to work based just on what we know about basic science should be at the back of the line for research dollars; they’re the kind of thing we test if we have extra money. What should get priority are projects based on a plausible scientific principle or, if the scientific principle is somewhat “out there,” on very compelling preclinical data.

    Moreover, implausible modalities that have been studied many times and found not to work better than placebo (homeopathy, chelation therapy for coronary artery disease, reiki, etc.) do not need to be tested again and again, but that’s what happens all too often because negative studies aren’t believed. Admittedly, this is also true when it comes to studies of “conventional” therapies, but to a much lesser extent than CAM. Unlike CAM advocates, science-based medicine practitioners will abandon a therapy sometimes even after one large, well-designed study showing it to be worthless or harmful. Not so CAM practitioners, who will cling to their favored modality endlessly. No matter how many negative studies are done, they will ask for another one. After a while, as the negative evidence piles up, it become unethical to subject patients to ineffective remedies in “just one more study.”

  8. #8 factician
    May 6, 2008

    In my field, to get a faculty position, you have to demonstrate that you *already* have federal funding – prior to getting a job. 2008 looks to be one of the bleakest years on record for young researchers. To get funding in my field, you have to have preliminary data suggesting that what you are proposing could possibly work. That said, it is hideously difficult to get a faculty position.

    It makes me more than a little bit angry to know that if I were dishonest or incompetent, that I would have an easier time getting money applying to the NCCAM.

  9. #9 DLC
    May 6, 2008

    If CAM (Craptacular Alternative to Medicine?) is so all-fired popular, where are the private research dollars ?
    I know of at least two charitable foundations which fund research on a grand scale. Is there no private foundation for CAM Research ? Federal Grant dollars should not be wasted on this stuff, not while there’s one good, quality science-based project to fund.

  10. #10 Prometheus
    May 6, 2008

    WFJAG has yet another good point: the ethics of “CAM” research.

    Since I pretty much discount all of the “cancer cures THEY don’t want you to know about”-type “CAM” treatments for cancer (and other ailments), I hadn’t even considered that someone might try one of them in place of a real treatment on a potentially curable (or even treatable) cancer. I guess that shows where my head is!

    But WFJAG is absolutely correct! It would be completely unethical to do a study of, for instance, green tea as a sole treatment for stage I breast cancer. Even if the subjects consisted solely of women who refused surgery and chemotherapy (although green tea could be thought of as a type of chemotherapy), it would probably be unethical.

    However, I can’t think of any ethical objections to a trial of green tea (again, “for instance”) in addition to the current best practice for stage I breast cancer. In fact, a study like that could be done at very little cost with a clinical population at any major cancer center or university hospital.

    Which only serves to “beg the question”: “Why hasn’t it been done already?”

    I don’t mean “Why hasn’t ‘the government’ paid for a study of green tea?”; I mean “Why haven’t the people promoting green tea (or homeopathy or Tai Chi or accupuncture or….) as an adjunctive therapy already done the study on their own?” They have a serious financial (and philosophical) incentive to do said study and the cost of at least a pilot study isn’t going to kill their profit margin.

    So why are they moping and whining about how “the government” isn’t studying their particular brand of woo (excuse me, “CAM”)? I can think of two possible reasons:

    [1] They are so unfamiliar with the methods of science that they don’t know how to do a simple pilot study with proper controls.

    [2] They are afraid of what a proper study would show about their bread-and-butter practice(s).

    The usual excuse proferred is “I don’t have the time to gather data from my busy practice – I’m saving lives here!” In reality, many (most?) haven’t even looked a their own “data”.

    Anecdote alert! I once asked a “practitioner” what their success rate was for a specific “therapy” and the answer I got was, “I’ve treated over 600 patients and 100% of them have improved!”. Amazing.

    Prometheus

  11. #11 pec
    May 6, 2008

    The standard treatments do not work for advanced cancer. Why is it unethical to deprive patients of treatments that don’t work?

    The standard treatments are credited with curing early cancer, but we have no idea if they ever do. Most early cancer would never progress, and earlier diagnosis automatically results in longer survival times.

    A toxic drug may slow the growth of tumors, but that’s only because it poisons the entire body and slows the growth and reproduction of all cells. The drug may kill cancer cells and shrink tumors, temporarily, only because it is lethal to life in general.

    Progress in cancer research is mostly, or entirely, an illusion. Refusing to change course and explore alternatives results from close-minded stubbornness and unwillingness to face facts.

    Most cancer researchers are mainstream, barking up the wrong trees for decades, and this would continue for all eternity if you had your way. You know you are not succeeding, but you jealously guard your funding sources, ridiculing and snarling at anything you don’t understand.

    Do you see any insanity in your behavior? You know that overdiagnosis and lead-time bias may account for most or all of the supposedly increasing cure rates. You know that advanced cancer is still as hopeless as ever. Yet you have the nerve to laugh at all alternatives, simply because you don’t understand them.

    Most of the alternatives will probably fail also. That is the way science, and life in general, works — most ideas are bad and are weeded out. But you want your bad ideas to prevail forever, and you want to deprive alternative ideas from ever being tested.

    You are not a scientist.

  12. #12 Marcus Ranum
    May 7, 2008

    Screw it. Maybe Reiki, Homeopathy, and Accupuncture and whatnot should be promoted as general treatments for whatever ails. That way the idiots who fall for it will die off faster.

    Has anyone ever measured the lifecycle cost of a person? Is it cheaper for society to let stupid people die of curable diseases at an early age rather than trying to keep them alive so that they can die of something really expensive like Alzheimer’s?

    I’m really serious about this. As medical costs continue to spiral upwards, maybe the best way to deal with aging populations is to have faith healers pat them on the head and give them some colored sugar water in a context where the hospitals have no liability and plausible deniability.

  13. #13 Marcus Ranum
    May 7, 2008

    pec writes:
    Yet you have the nerve to laugh at all alternatives, simply because you don’t understand them.

    A lot of the time, alternatives are laughed at because they don’t present anything like a theory for how they might possibly work. It’s not sufficient to say ‘you should try this! patients say it works!’ when the underlying theory of how a “cure” operates is based on some as-yet unmeasured property of some as-yet undiscovered form of energy, qi, vibration, or whatever. Absent a credible hypothesis of action, you’re basically left with a placebo or pure random luck.

    The more precisely an alternate remedy explains its theory of activity, the more easily it can be assessed for whether or not it’s even likely to work. Take homeopathy as an example: we have the theory of dilutions, and the initial form of that theory failed when considered in light of our understanding of how molecules and liquids work. There is literally no need to test it, because the basic premise of how it works is B.S. Of course the practitioners can make up more theories (“water memory”) but those also fail based on our understanding of physics. Until our understanding of physics is proved wrong, there’s no need to test homeopathy further. You need to either overthrow physics as we understand it, or I guarantee you you’re measuring the power of autosuggestion.

    I am absolutely sure that if someone could propose a test for how to measure the energy field generated by a Reiki practitioner, and that test held water vis-a-vis other facts we know about physical reality, then someone would be willing to test it. Again, the problem is that the theory offered by the alternative remedy doesn’t have any possible path of action other than autosuggestion.

    That _is_ science. Saying “scientists don’t know everything, therefore you should take things you know won’t work seriously” is complete bullshit. Science is not afraid of things we don’t know. But if you want a remedy you’re proposing to be taken seriously, you’ve got to have at least a theory for how it might work above and beyond hand-waving, anecdote, or vivid imagination.

  14. #14 wfjag
    May 7, 2008

    Thank you for the kind comment Prometheus.

    Pec: Your comment doesn’t indicate that you are a scientist. You wrote:

    “The standard treatments do not work for advanced cancer. Why is it unethical to deprive patients of treatments that don’t work?”

    That statement is untrue, in all respects.

    First, although many (if not most) of the standard treatments are not especially effective for advanced cancers (Plural deliberate. I’ll let Orac address the issue that all cancers are not alike, and there are treatments for some cancers even if in Stage III, since he’s the cancer researcher), the standard treatments are still often effective in slowing the progress of the particular cancer the treatments are for. So, the standard treatments frequently extend life, even if there is no “cure.”

    Second, there are spontaneous remissions.

    Third, and related, by slowing the course of the disease, the patient at least has some chance of a spontaneous remission or the developement of a new treatment or refinement of an existing treatment that will further slow the disease or cure it.

    Fourth, most States recognize “lost opportunity” as a wrongful death cause of action. Equating small chance with no chance is a way to become one of the 4% of physicians who are the subject of over 50% of the med mal claims. Referring a patient (or even standing by silently) to a treatment that doesn’t work is another way of equating small chance with no chance.

    Fifth, providing a “treatment” that doesn’t work is fraud.

    Finally, both legally and ethically, deciding to provide a treatment that doesn’t work isn’t a choice available to a physician. A physician can refer the patent to other specialists for second (and third, fourth, etc.) opinions. The physician should, also, recommend (strongly) that the patient discuss his/her case with an attorney (for executing an extraordinary care directive so that the patient decides that the plug should be pulled — or when it’s time to check out of the hospital and go home to die with some dignity, and to review the patient’s health care insurance and government programs coverages — since the patient may decide that bankrupting his/her family isn’t desired), and his/her family, and his/her spirtual advisor, and a mental health professional. But, in the end, the decision has to be made by the patient based on informed consent. Yes, a physician will have patients who are grasping at straws — and the physician, along with the other advisors, have an obligation to explain that desperate people are more likely to be defrauded, and explain the applicable science and medicine and consequences of a decision that the patient may consider making. The purpose of all the advisors is so that the patient makes his/her decision after being fully informed.

    Providing “treatments” that have no basis, other than someone said, that someone heard, that someone believes, that someone may have read, that maybe, might and perhaps it could be effective, is human experimentation. I know of no reputable scientist or physician who does that, and no ethical code that condones it.

  15. #15 Abel Pharmboy
    May 8, 2008

    Sorry to get to this so late but I wanted to weigh in as a strong critic of NCCAM but a supporter of NCI’s OCCAM in that the latter is much more committed to real science and issues of cancer patients being preyed upon by unscrupulous marketers. I would argue that each NIH Institute would best have a division like OCCAM to focus on the most widely used alternative therapies within each disease area and dismantle NCCAM.

    @factician, contrary to what you might think, NCCAM funding is not easy money at all. Looking at the NIH IC rankings for FY2007, overall funding success % (not percentiles, which are much lower) is barely 11% for NCCAM while it is about twice that for NCI, NIDDK, etc. In fact, many superb investigators are quite surprised when their NCCAM-directed grants get shitcanned.

    Back to OCCAM, I just received their annual report which notes that 80.3% of their funding goes toward the study of CAM therapies considered “nutritional therapeutic” or “pharmacological and biological treatments.” But as Orac and others point out, these are essentially experimental therapeutic medical modalities and NOT CAM under my pharmacologic definition. People who define themselves as CAM practitioners have co-opted what we consider experimental medicine (natural products, herbal supplements) or legitimate areas of health and medicine like nutrition, perhaps because these are the only CAM areas with a possibility of proving effective. Orac’s gem is well-worth repeating in this context:

    There’s no scientific rationale why such studies should be segregated away as “alternative”; they could and should be evaluated just like any other scientific study, and, worse segregating them into the CAM ghetto devalues them and, by association with the woo also being funded under the rubric of “CAM,” makes them look like woo too. [emphasis mine]

    However, I’ll still be critical of OCCAM where it is warranted, such as Orac’s experience with a representative carrying on with non-scientific terminology of what sounds like the simple study of pharmacological additivity/synergy. Not so sure of the source of funding of the “homeopathy” study Orac points out – it is listed on the NCI website but a CRISP database search fails to pull out the PI or product – by the way, Traumeel is not homeopathic; instead it is a dilute herbal extract mixture from plants with in vitro data supporting anti-inflammatory activity; at least one study published in 2002 in Cancer indicates that this product has some activity in relieving the mucositis/stomatitis associated with chemotherapy.

    I am certainly suffering like everyone else with NIH funding percentiles of 10-15 but I can justify that the more conceptually comprehensible of what is characterized as CAM is worthy of study, if for nothing else that to provide docs and allied health professionals with fuel to inform patients what works and what doesn’t. But as we’ve seen, and Orac points out, negative trials and preclinical studies do not dissuade CAM advocates from continuing to espouse their own Lost Cause. We can at least use facts to combat that stance.

  16. #16 Natalie
    May 8, 2008

    “Most early cancer would never progress, and earlier diagnosis automatically results in longer survival times.”

    Citation, please?

  17. #17 pec
    May 8, 2008

    “Citation, please?”

    The problems are well known and you can find articles in pubmed.

  18. #18 Wallace Sampson
    May 9, 2008

    It’s one thing to express opinion, another to misstate facts. Pec states that only early cancers are cured and that [many? Most” all?] of those are due to stage migration – lead time bias and other gliches in data collection and statistics. The latter – various biases – is true, but explains only part of the data. The rest is true curing and prolongation as shown by survival curves. “Alternatives”, complementaries, and folkway methods do not cure or prolong life.
    Same is true for advanced cancers – many cures, many more extensions of life. Pec seems to know where the bias reports are in Pubmed, but not where the cures and prolonged survival data are, reports of which far outnumber those of biases.

    Wiswal
    demonseu

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