Terra Sigillata

I just had a chance to check in on a triad of posts by Prof Janet Stemwedel at Adventures in Ethics and Science (1, 2, 3) on the ethical issues of the conduct of studies, particularly clinical trials, supported by the US NIH’s National Center for Complementary and Alternative Medicine (NCCAM).

For background, NCCAM was originally established for political, not scientific reasons, as the NIH Office of Alternative Medicine in October 1991. It received a token budget of $2 million at the time. They still only get $120-ish million; modest by NIH standards as compared, say, with the 2007 NCI budget of about $4.8 billion. But that $120-125 million is pretty significant in that it could fund about 60 independent researchers and their laboratory groups for five full years.

How was alternative medicine defined then? Primarily as folk and cultural modalities not incorporated into conventional Western medicine but used and promoted for disease treatment or prevention without statistically-defined efficacy and safety. The net was cast very wide, from “energy therapies” that defy the basic tenets of physics to herbal medicines that have given rise to 25% of prescription medicines.

Hence, CAM is not one modality. It is a term used to describe a wide spectrum of health-promoting approaches that have not been evaluated previously under rigorous, controlled basic or clinical science standards.

CAM is a terrible term. It is NOT medicine. Modalities proven to work are medicine. Modalities that don’t work are not medicine. There is no complement to medicine. Medicine is medicine. There is no integrative medicine, either. Medicine already takes advantage of all modalities: surgical, pharmacological, radiological, physical, psychological, nutritional – if a clear benefit can be offered to a patient that outweighs the risk.

So-called integrative medicine gurus have adopted proven, preventive medicine techniques – diet, exercise, meditation, yoga – and have used them 1) to justify that “CAM” works and 2) that the efficacy of these approaches justifies study and implementation of approaches that have absolutely no scientific basis.

Oh yeah, often with substantive personal financial benefit.

I must admit to having a dog in this fight. I have spent 23 years investigating the molecular action of chemicals derived from plants, fungi, and bacteria for their anticancer or cancer preventive activity. Some of these agents came from folk remedies, others came from pure compounds isolated from random plant sources because of the recognized chemical diversity of secondary metabolites produced by plants. Yet what I do is not of interest to NCCAM. I think it is, and well should be, but I have had no success convincing reviewers that what my lab and collaborators do will be informative to those studying the natural products side of untested herbal medicines.

Yet our nation’s health agency separates the evaluation of biomedical research proposals across over more than 110 topical areas. NCCAM instead is charged with evaluating research proposal investigating dozens of potential therapies across dozens of therapeutic settings. And that’s without even getting into the basic science foundations that might underlie the mechanism(s) of any potentially useful therapies. One could find an NCCAM grant application reviewed on reiki therapy for depression followed immediately by an application, say, studying a naturally-occurring plant product that inhibits the function of the hypoxia-induced transcription factor, HIF-1α, in cancer.

I must also make another disclosure: my laboratory has never received funding from NCCAM, although my collaborators and I have attempted repeatedly. Rather than write off NCCAM, though, I have offered instead to serve as a NCCAM grant reviewer and resolved to be part of the solution rather than whine about the problem (Review panel rosters are a matter of public record on the NIH website; while one can never be sure which reviewers were assigned one’s grant, an investigator is provided with the roster of all those assembled at the meeting).

NCCAM is, sadly, still a political entity and if my colleagues and I don’t agree to serve as scientific reviewers, we are likely to be substituted by individuals with lesser rigor and credentials. So, while it is in existence, I will continue to be part of it when called upon. Not telling tales out of school, I have provided strongly positive evaluations of a very small number grant applications for investigators and their projects that have been fantastic successes and published in top-tier peer-reviewed journals. Not many folks talk about this, but like some study section members I have followed the careers of basic and clinical investigators to whom I have given excellent scores to their research proposals. I am incredibly proud that I have served the scientific community by rigorously evaluating research proposals submitted to NCCAM.

However, these projects represent less than 5% of the projects I have reviewed for the agency. (No surprise since only 10-19% of NIH extramural projects are being funded these days.).

As a scientist, I share the proposal set forth others that NCCAM is really not necessary as an NIH entity. Untested therapies, and the basic science underlying their potential therapeutic efficacy, might be better evaluated by institutes or centers (ICs) of NIH dedicated to specific pathophysiological areas.

As far as I know, NCI is the only IC that has established an alternative medicine evaluation center that focuses on untested modalities for the broad area of cancer. The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) has a budget to support some intramural and extramural projects on therapies that may be of benefit to cancer patients.

In my very first blog post, I tried to note the diversity of rationale and application of so-called complementary therapies while invoking two of my science blogging mentors: Orac and the former-Dr Free-Ride, now Prof Janet Stemwedel. I have had the honor of knowing them both personally and respect both of their views in this area of the ethical and medical issues surrounding federal support of scientifically-valid, conceptually-possible, and absolutely implausible so-called alternative therapies. (A lively discussion currently ensues between them on studies supported by NCCAM.).

From 15 December 2005 at the old blog:

The polarizing quality of alternative medicine among academic health and life scientists is exemplified by the other extreme in the blogosphere: hucksters using blogs to sell supplements, services, books, etc. with dubious and often irrational claims of cures while feeding the conspiracy theorists with the idea that cures are out there that “they” don’t want you to know.

There are few folks in the middle ground. Orac Knows at Respectful Insolence and Doctor Free-Ride at Adventures in Ethics and Science often take on alternative medical claims in a thoughtful, balanced, respectful manner that is based in fact. But what I see missing in many blog threads, however, is 1) a distinction between the relative validity of each of the alternative modalities and 2) an honest appreciation for what the natural world has lent to modern medicine, healthcare and wellness.

I have to admit: it’s fun to look back at what one wrote more than three years ago.

Janet is correct to question how we evaluate therapies outside the realm of conventional belief; Orac is correct to criticize the existence of a political entity dedicated to prove things that are unlikely to be useful (based upon current basic science tenets).

The common thread here is that the discussion between Orac and Janet is being conducted by people trained in the scientific method: Orac is a MD, PhD, and Janet holds two PhDs, one of which is in physical chemistry. Neither is a finanically-driven woo-peddler or an anti-natural product person (as a breast oncologist, 55% of the drugs Orac’s patients are given are naturally-derived).

Where I worry is when such discussions are held amongst patients and those trying to make a buck out of their misery and uncertainty.

Comments

  1. #1 anjou
    March 18, 2009

    “Where I worry is when such discussions are held amongst patients and those trying to make a buck out of their misery and uncertainty.”

    Amen, and Thanks– anjou

  2. #2 Name Withheld
    March 18, 2009

    Great post, and I totally agree with this as you’ve laid it out. But the on the ground reality in at least one CAM center (funded as described) is not as bad as one might think.

    I recently served on, essentially, an oral exam for an undergraduate trained in one of these programs. I had not previously worked with this student, but I could not resist what I felt was a professional urge (as a scientist) to bring the whole thing into question, while at the same time not being mean to an undergrad whom I’ve never met before (and thus had no basis to calibrate an interaction that might be critical).

    So, I asked the most obvious question one asks in such a situation.

    “Give me one or more good examples of something that you and those with whom you were working at the beginning of your studies (which had been six years earlier) thought might be true that subsequence research has has disproved.”

    And the answer was (relatively) satisfying:

    “We used to think that each treatment (and she named a number of “alternative” treatment thingies) was ideal for a different disease or condition. This is now clearly not true. There is no one treatment for any one condition. Instead, anything we do seems to serve to reduce stress, which is helpful.”

    Not a bad answer. And yes, on further probing, she gets that stress can be defined in certain physiological terms and so on.

  3. #3 Chemgeek
    March 19, 2009

    I’ve always wished the NCCAM was actually the NCECAM where the “E” stands for “the Evaluation of.” Let’s study these things in legitimate, science-based, controlled ways (without causing harm, of course). If something works, great. Let’s exploit it. If it doesn’t (and there will be a lot in this category), throw it out. As it stands now, the NCCAM is political, it is pandering and it is dangerous.

  4. #4 Karl Schwartz
    March 19, 2009

    Thanks, Abel

    What’s in a name, right?

    * National Center for Preventive Medicine … yes

    * National Center for Unproven Medicine … Nonsense

    * National Center for Unproven Medicine Integrated into Standard Practice? … Nonsense

    * NCI Natural Products Division … As you know, we have that and it makes perfect sense

  5. #5 JCastron
    March 19, 2009

    It is obvious where you are coming from but please write the upwards of 300,000 people annually,that die, are maimed, and suffer needlessly under the guise of ‘Medicine’.

    We’ll start with Vioxx and leap to Thalidomide with millions, not thousands, but millions of poor souls suffering under the charlatan Oncological/medical field. Hucksters in CAM? You betcha! Hucksters in your favorite term? Medicne? Legions more than in CAM/Alternative carte.

    What we did not mention, was the millions suffering needless surgery, surgery admitted by your own to be unnecessary.

    Where have you been except for being beneath the AIG hucksters? JC

  6. #6 Gopal Pandey
    March 19, 2009

    A self taught science student have “practiced” homeopathy for family and friends successfully for some 15 years. I have had unbelievable results e.g. have cured, yes cured Non-hodgkins lymphoma, hypertension, hyper-acidity; shingles and latest believe it not diabetes. One remedy works for one patient and it will not work for another for the same condition. So the question of blind trials for the blind does not arise.

    I don’t belong to any association or trade group that may have an axe to grind.

  7. #7 Joe
    March 19, 2009

    Posted by: Gopal Pandey | March 19, 2009 12:22 PM wrote “A self taught science student …” I fear your teacher was incompetent.

    I have had unbelievable results …” Yes, I am sure you have. Your testimonial cannot be believed as support for homeopathy.

    You need to find a better teacher, try http://www.quackwatch.org and http://www.skepdic.com

  8. #8 Calli Arcale
    March 19, 2009

    It is obvious where you are coming from but please write the upwards of 300,000 people annually,that die, are maimed, and suffer needlessly under the guise of ‘Medicine’.

    So, because treating disease is serious business, with lots of money at stake and the powerful temptation to hide inconvenient side effects…..

    …you think we should abandon mainstream medicine, the only medicine that’s actually regulated at all, and just go with the “just trust us, it works, and if it doesn’t it’s not our fault because we didn’t really tell you it works” folks who peddle CAM remedies?

    If anything, the Vioxx scandal is evidence that entities like the FDA are desperately needed. It was science that brought that to light. Outside of mainstream medicine, science is rarely seen, and the frauds and failures go blissfully about their work, often unaware of the human toll. Breast cancer patients seen by naturopaths, who finally seek medical care only to be told that it is now too late. Children suffering death or disability due to preventable diseases because someone convinced them not to vaccinate. Weight-obsessed women who are humored by fringe specialists who give them ephedra, drink coffee, go running, and fall down dead from a heart attack. People getting expensive and dangerous chelation therapy to ward off heart attacks, which, since most of them are not really at risk, never occur, making the treatment appear beneficial even though multiple clinical trials years ago proved it ineffective.

    Don’t trust anybody selling remedies. Don’t trust Wyeth, and don’t trust Pilgrim’s Pride either. The main difference between the two is that only one of them has a watchdog looking over its shoulder, ready to bite if it plays too fast and loose with the data and people get hurt.

    Vioxx caused real harm, and the manufacturer got into serious trouble. Why don’t the promoters of chelation get into similar trouble, despite having far less evidence on their side, and several actual deaths at their doorstep? Because they’re CAM, that’s why, and people give them a pass because of it.

  9. #9 antipodean
    March 19, 2009

    Abel Said “(CAM)It is a term used to describe a wide spectrum of health-promoting approaches that have not been evaluated previously under rigorous, controlled basic or clinical science standards.”

    I think this is partially correct. But I think it too narrow a definition.

    Firstly, I wouldn’t call them health-promoting until they had actually been evaluated and shown to promote health.

    Secondly, CAM also includes a great many modalities that either have been tested properly and been found ineffective or havn’t been tested properly because they cannot possibly work under the established physical laws of the universe (i.e. are utterly improbable). In some cases, such as homeopathy, both statements are true.

    I wish Abel’s definition was operationally descriptive. But unfortunately this stuff continues despite any evidence against it and in spite of absolutely no evidence for it. It’s wishful thinking, huckerism and religion. Not medical science.

  10. #10 antipodean
    March 19, 2009

    Horrible last paragraph. I’ll try again.

    I wish Abel’s definition was operationally descriptive. But unfortunately the worst stuff continues to be welcomed under the umbrella of CAM- and this is despite all the evidence against it and in spite of absolutely no evidence for it. It’s wishful thinking, hucksterism and religion. Not medical science.

  11. #11 Tristan
    March 20, 2009

    I have had unbelievable results e.g. have cured, yes cured Non-hodgkins lymphoma, hypertension, hyper-acidity; shingles and latest believe it not diabetes.

    Yeah. I’m going to go with… not.

  12. #12 Jack Coupal, Ph.D.
    March 21, 2009

    It’s understandable that practitioners of tradional medical sciences are enraged at complementary and alternative medicine.

    The people who have benefited from CAM, when the traditional medical sciences have been unsuccessful – or less than successful – in helping such people, will continue their advocacy for CAM.

    It may be soothing to our ego to bash CAM, but until we in traditional medicine address the legitimate wants and needs of CAM advocates, we will be on the losing side.

  13. #13 Joe
    March 21, 2009

    Jack Coupal, Ph.D. | March 21, 2009 9:14 AM wrote “The people who have benefited from CAM …”

    Who, aside from the purveyors who profit from CAM, has benefited?

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