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NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?

Francis Collins “gets it” about as well as Josephine Briggs

We here at SBM have written frequently and copiously about the National Center for Complemnatary and Alternative Medicine, a.k.a. NCCAM, a.k.a. the Barad-dûr to SBM’s Minas Tirith. OK, I exaggerate. Just a bit. NCCAM director Josephine Briggs is a real scientist, and I have no doubt that she wants to make NCCAM more scientifically rigorous than it has been in the past. Unfortunately, the recent five year strategic plan she developed, along with her reaction to having met with Steve Novella, Kimball Atwood, and me in 2010, leads me to believe that she either doesn’t understand or refuses to acknowledge the problem at the very core of NCCAM: namely, that it is charged with studying treatment modalities that are inherently unscientific, being as they are based on prescientific or demonstrably incorrect understandings of human physiology and disease. “Rebranding” CAM as “harnessing the power of the placebo effect” will only go so far in putting lipstick on that pig, and trying to emphasize natural products begs the question of why a separate “CAM” institute is needed to do pharmacognosy research.

Be that as it may, NCCAM is a political, not a scientific, construct, because CAM is an ideological, not a scientific, construct. There is nothing tying together the disparate “disciplines,” treatments, and woo lumped together under the rubric of CAM/IM other than that they either (1) have not been scientifically demonstrated to have efficacy; (2) have been demonstrated not to have efficacy; or (3) are diet and exercise or other interventions that should fall under the purview of SBM but have been co-opted by CAM/IM believers along with the woo because they are modalities that have proven health benefits and including them along with all the pseudoscience makes the pseudoscience seem more plausible. It’s not for nothing that I frequently refer to diet, nutrition, and pharmacognosy as the “Trojan horses” of CAM. These modalities have more than a modicum of plausibility (although it should be pointed out that the way they are represented by CAM often does not, vastly overselling the benefits or fusing science-based recommendations with pseudoscience). “Energy healing,” acupuncture, reiki, the vast majority of TCM, Ayurveda, and many other modalities that fall under the CAM umbrella do not, and that is the problem.

Unfortunately, it’s quite obvious that Collins does not “get” this. Although he changed the title of his talk from the original title of “Faith, Spirituality and Science in Oncology,” the actual talk he gave, entitled “Seeking Out the Most Effective Interventions for Cancer Prevention and Treatment,” still falls hook, line, and sinker for one of the favorite arguments of CAM proponents, the argumentum ad populum (i.e., appeal to popularity):

“Many new frontiers exist in integrative medicine,” NIH Director Francis Collins, MD, PhD, stated in his keynote address at the Eighth International Conference of the Society for Integrative Oncology (SIO) in Cleveland. “The evidence is overwhelming that these approaches are being used by many individuals in the United States, including those with cancer,” he said. “For wellness, immune function, and pain-related symptoms, there is a significant increase in interest among cancer survivors compared to other people who use complementary and alternative medicine.”

Survey data show that over a lifetime, complementary and alternative medicine (CAM) is used by “65% of cancer survivors vs 53% of noncancer respondents,” he said. When questioned about motivations to use CAM, cancer survivors “are more likely to be using this because they are unhappy that medical treatments have not helped them or because it has been recommended by the provider,” he noted.

As Steve Novella has pointed out, the appeal to popularity is the most ubiquitous argument used in CAM apologetics. In brief, it argues that, because CAM is seemingly popular, there must be something to it and we should study it. If you look at the figures, on the surface Collins’ figures appear to be correct. However, such figures are hugely inflated by inclusion of things like massage, vitamins and supplements, yoga, and prayer. That’s how studies of tai chi in fibromyalgia, for instance, make it into the New England Journal of Medicine labeled as “CAM” when in fact they are merely studies that demonstrate that gentle exercise appears to be helpful in alleviating fibromyalgia symptoms. As Steve also pointed out, most hard-core CAM modalities are actually used by a very small percentage of the population, with most falling in single digit percentages. For example, acupuncture use is around 6.5%; Ayurveda, 0.6%; chelation therapy, 0.3%; energy healing, 1.7%; naturopathy, 1.5%; and homeopathy, 3.7%. These are hardly impressive numbers. In addition, these numbers are not significantly different from numbers reported 10 or 20 years ago – belying the claim that CAM use is increasing. In any case, the number I usually see for the percentage of cancer patients reporting having used CAM is less than 50%. I don’t know where Collins got his figure of 65%.

In fact, while looking for the source of Collins’ information, I found this recent meta-analysis that, while claiming to find that CAM usage among cancer patients is increasing, still only estimated it at 40% in American patients, way lower than the 65% claimed by Dr. Collins. It’s actually a fairly maddening study in that the definition of CAM therapies for purposes of inclusion in the various studies is not listed in the paper. Rather, it’s listed in an online supplement mentioned in the paper that I couldn’t find. In any case, particularly interesting to me was this passage in the discussion:

Surveys that restricted CAM use to certain categories or treatments yielded lower prevalence estimates than surveys that did not. This is exemplified by the study from Abu Realh et al,120 who confined their definition of CAM use to mind-body approaches, counseling, and attendance to self-help groups and found that 12% of respondents were “CAM users.” Accordingly, studies with broad definitions of CAM use tended to inflate estimates: for example, many of the included surveys with very high usage rates had integrated prayer and exercise defined as CAM, and the usage rate would have been approximately halved if these therapies had not been included. We planned to systematically address the question of how different definitions for the term CAM would influence the results in surveys. However, this was not feasible because authors seldom stated how they defined CAM for the purpose of their study. Moreover, even in studies from the same country, in which the same type of definition was used, the CAM treatments included varied substantially.

It’s a shame that Dr. Collins apparently either doesn’t recognize such distinctions or was too unconcerned to look more in depth into whether claims of CAM use in cancer patients by CAM advocates are accurate. They are, as Steve and I have pointed out, hugely inflated by the inclusion of modalities that aren’t really medicine (prayer, for instance) or through the inclusion of of modalities that are arguably not CAM, such as vitamin use (which might or might not be science-based depending upon the specific use), exercise, and nutrition. Even sensationalistic news coverage comes up with lower estimates than Collins did. Next up on Collins’ hit parade is a citation of a study from M. D. Anderson Cancer Center that reports that 52% of cancer patients are using CAM during phase I trials, but that 23% don’t disclose that information to trialists. This is indeed a disturbing figure, but it is not a justification for NCCAM, a specialty known as “integrative oncology,” or CAM itself. Rather, it’s a figure that tells us that we should do more research in drug interactions with natural products, something that could easily be done under the auspices of non-CAM funding mechanisms in the NIH.

In fact, I find this whole line of argument confusing. Collins went on to proclaim how the goals of NCCAM are “very much aligned” with those of the SIO and then used the following as his examples:

“We need to do this research, not only to find out what works, but to find out what interventions actually may be harmful,” no matter how unlikely that may seem, Dr. Collins commented. For example, he pointed to the story of beta-carotene in cancer prevention. In the 1980s, epidemiologic evidence suggested that beta-carotene might decrease lung cancer risk. Double-blind clinical trials were initiated, and in the 1990s, those trials showed that “not only is beta-carotene not protective, it actually increased lung cancer risk—16% in one study and 28% in another—and so the studies were halted.” A follow-up study in 2004 corroborated those results.

This is, of course, a massive straw man coupled with a non sequitur. No one seriously argues that scientists shouldn’t try to find out what works and what doesn’t. In addition, the examples Collins cites are not in any way “alternative,” “integrative,” or “complementary.” Beta-carotene is a chemical found in some foods that can act as a drug or nutrient. There was preliminary epidemiological evidence suggesting that beta-carotene might decrease the risk of lung cancer. Scientists then did what scientists do: They performed randomized, double-blind clinical trials to test the hypothesis, which seemed plausible when the trials were initiated. Unfortunately, the results of these clinical trials turned out not to be what had been anticipated; not only did beta-carotene not prevent lung cancer, but it increased the risk of dying of lung cancer in smokers. How this relates to “CAM” or “IM” is tenuous at best. This is SBM at work. The same is true of the other example cited by Collins, that of vitamin E and selenium as preventatives for prostate cancer that, when tested in randomized clinical trials, actually slightly increased the risk of prostate cancer. So, while I agree with Collins that “That’s the kind of data we need if we are going to be giving rational recommendations to patients and providers about how to practice better prevention and treatment,” I disagree that such studies are in fact “integrative” or “alternative” or “complementary” or whatever CAM proponents like to call such supplementation these days. They are, in fact, SBM. Beta-carotene and the vitamin E/selenium combination are simply proposed therapies that had a modicum of plausibility to them as a preventative strategy for different cancers that failed when tested in rigorous randomized clinical trials. This happens all the time in SBM; it’s why we do clinical trials.

In essence, whether he knows it or not, Collins has fallen for the old “bait and switch” of CAM/IM, just as NCCAM director Josephine Briggs has.

“Personalized” medicine and CAM

I’ve written many times before about how CAM co-opts the idea of “personalized medicine” for itself when in fact what “personalized medicine” means in CAM tends to involve practitioners “making it up as they go along” and the co-opting of the term as a strategy to attack evidence-based medicine as being “one size fits all.” Some, such as Dr. Stanislaw Burzynski, co-opt the term as a science-y-sounding way to make his very own “make it up as you go along” mish-mash of targeted cancer therapies, antineoplastons, and chemotherapy sound as though he knows what he’s doing.

Collins, disappointingly, buys into this frame. Whether he does this knowingly or unknowingly, I don’t know. (I suspect the latter.) First, he touts NIH initiatives, such as the Cancer Genome Atlas, a project that will sequence the genomes of many cancers and try to draw conclusions about the genetic abnormalities that drive cancer growth and determine responsiveness to various therapies. It’s an ambitious (and risky) project that has almost nothing to do with CAM, although CAM proponents have tried to claim such projects as their own, the most hilariously off-base example being so-called Ayurvedomics. This is a strategy that appears to be echoed in one of the talks given at the SIO conference by Jeffrey A. Dusek, PhD, entitled, “Mind-Body Strategies and Epigenetics.” In any case, Collins points out how “big numbers” are needed to be able to draw any useful correlations and understandings of patterns of genetic derangements in various cancers. No doubt this is true, but it is also irrelevant to CAM, as is this example he cites:

As “a dramatic example” of the new targeted, personalized approach to cancer treatment, Dr. Collins described the case of a woman, a nonsmoker who was diagnosed with very aggressive, stage IV non–small cell lung cancer in both lungs about 4 years ago. Following standard chemotherapy, she participated in a clinical trial with crizotinib (Xalkori). Prominent lung metastases shown on x-ray in July 2009 “were essentially gone by November 2009,” Dr. Collins reported. “So she has had a dramatic response, and she continues to do extremely well,” he added.

“Of course this drug doesn’t work for everybody with this kind of lung cancer. So what’s the difference? It depends on whether the particular cancer has a fusion involving the ALK gene,” Dr. Collins explained. “Crizotinib was not developed with that particular target in mind, but it turned out after the fact that this was going to be a very responsive situation.” The success of crizotinib when used in a targeted personalized approach led to its approval by the FDA several months ago. Yet the drug may not have been approved if it “had been tried on thousands of people with lung cancer without having stratified them by the specific molecular findings,” Dr. Collins said.

Triumphs such as these are promising harbingers of a potential new age of personalized medicine and illustrate the potential power of such approaches. They do not, however, illustrate anything about CAM. Neither does the other example cited, that of a promising new approach of modulating the immune system to stimulate a patient’s own cells to attack cancer cells in chronic lymphocytic leukemia. This sort of science-based immunotherapy is related to claims of “boosting the immune system” promoted by CAM aficionados only by coincidence or in the way that the germ theory of disease as understood today is related to miasma theory from 200 years ago. Yet Collins seems to think that these promising avenues in the science-based treatment of cancer are somehow related to “integrative oncology.” In fact, he falls for the “bait and switch” even harder:

“We also have great excitement about a new era in therapeutics based on natural remedies,” Dr. Collins said. The NCI has an ongoing program looking for anticancer activity in extracts from plants, marine invertebrates, and microbes. “We are also seeking opportunities by looking at traditional medicines, many of them from China, for how we can decrease the side effects of treatment.”

All of which is pharmacognosy, not “CAM,” As David Kroll pointed out not too long ago:

But pharmacognosy – the study of natural products – is *not* alternative medicine. It is, in fact, the basis for at least 25% of our prescription drugs and up to 60% of some classes of over-the-counter drugs.

And:

What worries me more is how pharmacognosy is approached by NCCAM and how damaging their supported studies can be in leading us to dismiss potentially useful botanical medicines. In attempting to show political supporters the benefits of alternative medicines, NCCAM seems to spend a disproportionate share of their appropriation on expensive clinical trials. My concern has been that clinical trials are warranted when sufficient basic science has been conducted. However, the rush to clinical trials has instead led to multiple clinical trials failures.

The problem, of course, is that NCCAM and “integrative oncology” are not about pharmacognosy, other than “rebranding” it and fusing it with pseudoscience. They are about magical thinking and what Harriet Hall likes to call tooth fairy science. Dr. Briggs might have brought more scientific rigor and a more true pharmacognosy-like approach to NCCAM for the moment, but she will not be NCCAM director forever. One day she will retire or move on. When that happens, the institutional inertia will likely cause NCCAM to revert to its old ways.

What Francis Collins doesn’t know about “integrative oncology”

One of the reasons that quackademic medicine can flourish is that respected scientists like Francis Collins do not understand what it is about. That’s because in general they are unaware of what “integrative medicine” is all about, and many quackademics are quite good at cloaking their woo in convincing-sounding scientific language. Certainly, they have donned the language of evidence-based medicine and of “patient-centered” care like the proverbial cloak of invisibility in the Harry Potter novels and movies to hide the pseudoscience, as Kimball Atwood so eloquently described and I reiterated in my open letter to Dr. Collins and my post entitled “Integrative” oncology: Trojan horse, quackademic medicine, or both? I won’t retread old ground other than to point out that “integrative” oncology in reality means “integrating” quackery and pseudoscience into science-based medicine. I will, however, take a look at the agenda for the SIO meeting at which Collins was the keynote speaker.

A brief perusal of the SIO meeting program reveals a few tidbits, in no particular order, some with and some without my comment:

  1. Gillian Flower; Kieran Cooley; Dugald Seely. Adjunctive cancer care at the Canadian College of Naturopathic Medicine: A prospective, longitudinal, observational cohort study. One notes that “naturopathic oncology” includes homeopathy and a variety of other forms of quackery. Too bad the abstract is not online. In any case, one notes that the lead author Gillian Flower offers acupuncture, high dose intravenous vitamin therapy, acupuncture, and bogus “electrodermal testing” in her practice.
  2. Garrett Sullivan; Qi Chen; Ping Chen; Julia Chapman; Mark Levine; Jeanne Drisko. Prospective randomized phase I/IIa pilot trial to assess safety and benefit administering high-dose intravenous ascorbate in combination with chemotherapy in newly diagnosed advanced stage III or Stage IV ovarian cancer. That’s high dose intravenous vitamin C, people.
  3. Lucille Marchand, Diana Wilkie, Jun Mao, Kimberly Fleisher (Discussant: William Collinge). Moderated panel 6. Massage and Energy Therapy Research.
  4. Alejandro Chaoul; Kelly Bieger; Tenzin Rinpoche; Amy Spelman; Christina Meyers; Deborah Fry; Ideen Zeinali; Banu Arun; Janna Taylor. Tibetan Sound Meditation Improves Cognitive Dysfunction, Mental Health, and Spirituality in Women with Breast Cancer.
  5. Barrie Cassileth; Amy Matecki; K. Simon Yeung; Carmencita Mercado-Poe; Marci Coleton; Lisa Bailey; James Lozada; Martha Tracy; Gary Cecchi. Safety of Acupuncture for Upper Extremity Lymphedema in Breast Cancer Patients: Lessons from two major Medical Centers. Define “safety.” As a surgeon who sees a fair number of patients with lymphedema due to breast cancer surgery, the thought of sticking needles into the lymphedematous limb causes me to shudder, given how prone limbs with lymphedema are to infection and how—shall we say?—unconcerned about sterile technique most acupuncturists are. (Just ask Mark Crislip if you don’t believe me.)

I could go on, given that there is a lot more there, but I’ll wind up with my favorite session of all, one that I might have actually been interested in attending. Yes, I’m talking about the Integrative Tumor Board. For those of you not familiar with what a tumor board is, it’s a meeting where all the relevant specialties are together in one room to discuss the cases of individual cancer patients in order to formulate the best evidence-based treatment plan that the multidisciplinary team can come up with. Of course, this tumor board has a bit…laxer definition of “specialty.” This tumor board includes two medical oncologists (one of whom is the medical director of the M.D. Anderson Integrative Medicine Center), an MD/acupuncturist, a naturopath from Bastyr university, a nutritionist from Nutritional Solutions (now there’s an idea for a future post!) and a nurse who is interested in “mind-body” medicine. One notes that there are no surgeons, no radiation oncologists, and no genetics counselors, most of whom tend to be on tumor boards, depending upon the tumor type. One wonders what sorts of cases this tumor board discussed and what recommendations its members gave for the cases chosen to be presented.

It’s extremely disappointing that Dr. Collins agreed to appear as the keynote speaker for the SIO conference, but it’s even more disappointing that, instead of using his forum to challenge the SIO to abandon pseudoscience, he instead fell right into their frame of co-opting science-based modalities as being somehow “alternative.” He even bragged about how much support the NIH has given to such research, pointing out that the Office of Cancer Complementary and Alternative Medicine (which has the unfortunate acronym OCCAM) in the National Cancer Institute has a budget even larger than that of NCCAM and saying:

While NCCAM is an important focus of efforts at NIH, other institutes within NIH also have initiatives in complementary and alternative medicine, Dr. Collins noted. “The NCI has the largest one by far,” he said, and “the budget for CAM in the NCI is actually slightly larger than the entire budget of NCCAM. The total investment that NIH makes in complementary and alternative medicine research in 1 year is about a half-billion dollars. I wish it was more, but I wish everything we are doing in biomedical research could be more,” he said.

As I’ve said before, I wish it were less, as in zero, and all the money wasted on pseudoscience or putting a pseudoscience spin on what should be SBM distributed to the rest of the NIH. There is nothing that NCCAM or OCCAM does that requires a special, dedicated office or center in the NIH. Unfortunately, Collins uses the dire funding situation of the NIH to make the wrong argument about CAM research funding:

“The opportunities for medical research have never been greater than they are right now, and yet the threat to the support of biomedical research has—in the memories of anybody who is currently working in the field—never been greater either,” Dr. Collins stated. He noted that in fiscal year 2011, “for only the second time in 40 years, the NIH budget sustained a real cut.” If the failure of the Joint Select Committee on Deficit Reduction (the so-called supercommittee) to cut $1.2 trillion from the budget results in sequestering of discretionary budgets, “a dramatic downturn in support for biomedical research” could occur in fiscal year 2013, Dr. Collins said.

We now know, of course, that the supercommittee did fail to come to an agreement and that sequestering of discretionary budgets is all but assured in 2013. To me that’s all the more reason that waste such as NCCAM and OCCAM should be rooted out of the NIH, in order to make the best possible use of the remaining funds. Look at it this way. Only the top 7% of new research grant applications to the NCI are currently being funded, down from the top 16% back when I got my R01 in 2005, with no improvement in sight. In some NIH institutes, I’ve been told, it’s only the top 5% being funded. Meanwhile, investigators used to have two opportunities to revise and resubmit rejected proposals; now they can only revise and resubmit once. When funding gets this tight, there are lots of innovative projects, chock full of good science, that don’t make the cut and don’t get funded. I fully agree with Dr. Collins that the case for funding medical research has never been stronger and that the threat to the NIH has never been greater. At least 20 years ago, which was the last time funding was so tight, there appeared to be hope that an end was in sight. Not so today.

I realize that Dr. Collins was tailoring his address to his audience. I also realize that Collins is not just a scientist and administrator, but a politician. He has to be to have become director of the NIH and to have held all the other prominent leadership positions he has held during his career. Even so, it’s hard not to come to the conclusion that, like so many physicians and scientists, he just doesn’t “get” the problem of CAM and pseudoscience infiltrating medicine. At least, I hope that’s the case. What would be worse is if he either didn’t care or supported it.

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (37) ↓

37 thoughts on “NIH Director Francis Collins doesn’t understand the problem with CAM

  1. DrRobert says:

    *Bow’s down before Dr. Gorski*

  2. cervantes says:

    I’m not sure why you would exclude prayer from the definition of CAM. Christian faith healing is by far the most common non-scientific healing method that Americans report using, and I don’t see why it somehow doesn’t count the same way as Reiki or guided imagery or Ayurveda counts. The evidence base is the same and so is the plausibility.

    Oh yeah, one more thing – Francis Collins believes in it. That may be a good part of the explanation for this unfortunate flirtation.

  3. nybgrus says:

    I would argue it should be removed from the “definition” of CAM because the vast majority of Americans are religious. So they prayer regardless of the root reason for it. It is just something they do anyway and when they or a family member gets sick they just change the words they think to themselves.

    Reiki is something sought out as a therapeutic intervention, and not done every day anyways in the lives of millions of people for things like winning football games or finding lost car keys.

    So for that reason it illegitamately inflates the metric in question – how many people actually seek out and use “CAM.”

  4. rork says:

    Over-the-top. Did Collins support any particular CAM modalities?
    My optimistic take:
    I think and hope Collins is trying to corral the herd with carrots. If we can’t cut off the money, at least we can improve what kinds of projects get funded as “CAM”. Study of plant products for example, or these vitamin trials. Rather than pointing out it’s not CAM according to someone’s definition, why not make more of so-called CAM funding be spent on such useful science? The (underhanded) goal would be to gut CAM research of things actually CAM – only the words would remain, and we will have changed their definition. In the science of the possible, that might be what is possible.
    His views of evolution and religion may be crazy, but I won’t conclude Collins has drunk the Kool-aid of CAM, yet. I can change my mind though.

  5. David Gorski says:

    Collins didn’t have to support any particular CAM modalities, nor is that what I was arguing. Nor did I argue that he has drunk the Kool Aid of CAM. That is a bit of a straw man argument, from where I’m standing. Collins simply appears not to understand the issues involved or not to care. He appears to be, at the very least, a shruggie who buys into the CAM framing of its treatments (for instance his whole spiel on cancer genomics and “personalized medicine”). To me, this is a disturbing trait in an NIH director.

  6. Eugenie Mielczarek says:

    Many CAM studies ignore the basic laws of physics and chemistry but amazingly almost always report some weak positive outcome for the protocol-which justifies further funding. Obviously what is being recorded is either bad data or a placebo effect. The last thing we need are managed health research funds to test the basic laws of science.
    Jean Mielczarek

  7. Scott says:

    @ nybgrus:

    Certainly that calls for considering the intent, rather than excluding it entirely? Prayer as a normal religious activity wouldn’t count, prayer which is intended to bring about healing would.

  8. nybgrus says:

    @scott:

    Sure. But it isn’t. And that is much tougher to quantify.

    Plus, I would still argue that just changing your internal monologue isn’t a “CAM seeking behavior.” However, going to a faith healer or a Christian “science” healing room would.

  9. cervantes says:

    The only difference between praying for healing and Reiki is that Christian prayer is widely accepted and many people consider it offensive to question it. We still call it CAM when people buy homeopathic products over the counter or follow dietary protocols they read about somewhere — you don’t have to go to a practitioner for it to count. Why is prayer any different again?

    At the same time, lots of people do put money in the pockets of charlatans at healing services. It’s very big business.

  10. DrRobert says:

    Pray healing? Speak of the devil, I happen to have some studies handy:

    In 2000, a systematic review examined the data on the efficacy of any form of “distant healing” (prayer, mental healing, Therapeutic Touch, or spiritual healing) as treatment for any medical condition. The review found no high quality evidence to support the use of “distant healing” for the treatment of any medical condition. (Astin 2000)

    In 2001, a study investigated the efficacy of spiritual healing for the treatment of chronic pain. One hundred and twenty patients suffering from chronic pain, predominantly of neuropathic and nociceptive origin resistant to conventional treatments, were recruited from a Pain Management Clinic. The trial had two parts: face-to-face healing or simulated face-to-face healing for 30 min per week for 8 weeks (part I); and distant healing or no healing for 30 min per week for 8 weeks (part II). There were no statistically significant differences between healing and control groups in either part. In fact, the patients receiving no healing in part II had greater healing than those receiving distance healing. It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients. (Abbot 2001)

    In 2003, an update to the 2000 systematic review of “distant healing” was performed due to several rigorous new studies having been performed. The reviewers found that the majority of the rigorous trials do not to support the hypothesis that distant healing has specific therapeutic effects. The review concluded that “distant healing” has no effect beyond placebo. (Ernst 2003)

    In 2006, a multi-center randomized trial (Benson 2006) assessed the effectiveness of receiving prayer on patients’ recovery after coronary artery bypass graft (CABG) surgery. Specifically, it was evaluated whether receiving intercessory prayer or being certain of receiving intercessory prayer was associated with greater recovery.

    Patients were assigned to 1 of 3 groups. The first group received prayer after being informed that they may or may not receive prayer. The second group did not receive prayer after also being informed they may or may not receive prayer. The third group received prayer after being informed they would receive prayer. Prayer was provided for 14 days, starting the night before undergoing CABG.

    In the 2 groups uncertain about receiving intercessory prayer, complications occurred in 52% of patients who received intercessory prayer versus 51% of those who did not. Complications occurred in 59% of patients certain of receiving intercessory prayer compared with the 52% of those uncertain of receiving intercessory prayer.

    The finding that people who were certain they received prayer had more complications than those who weren’t was statistically significant. Strangely, the authors of this study downplayed this finding. The study found no beneficial effect of receiving prayer in patients undergoing CABG.

    The study concluded:

    Intercessory prayer itself had no effect on complication-free recovery from CABG, but certainty of receiving intercessory prayer was associated with a higher incidence of complications.

    In 2007, a systematic review examined the effectiveness of prayer as an additional intervention for those with health problems already receiving standard medical care. Any randomized trial of personal, focused, committed and organised intercessory prayer with those interceding holding some belief that they are praying to a God were included. The reviewers found no evidence that prayer is an effective supplemental intervention for any health condition. The review noted that in one larger study patients who were aware they were receiving prayer had significantly more post operative complications than those not receiving prayer and those uncertain if they were receiving prayer. (Roberts 2007)

    In 1998, a review examined 172 cases of death among children from 1975 to 1995 who were treated by faith healers instead of conventional medicine. The review found, that of these 172 deaths, 140 of the children would have had a 90% survival rate if treated by conventional medicine. 18 more had expected survival rates of greater than 50%. All but 3 of the remaining children would likely have had some benefit from clinical help. (Asser 1998)

    In 2004, a study noted that over 200 children have died in the U.S. of treatable illnesses as a result of their parents relying on spiritual healing rather than conventional medical treatment. (Hickey 2004)

  11. Janet Camp says:

    Has Collins been sent a copy of this post? If he’s just a shruggie, then it’s worth it to attempt to persuade him to come off the fence onto the side of reason.

  12. Jann Bellamy says:

    At least part of CAM’s “popularity” must necessarily derive from the fact that people using it think it is effective. Otherwise, why would they bother? This illusion of effectiveness is based on claims made by sellers of CAM products and practices which are either out and out fabrications (e.g., “you are suffering from vertebral subluxations”) or misleading (e.g., “supports immune function”). It is obvious that if one is allowed to sell a product or therapy based on false or misleading claims of effectiveness one will have a distinct advantage over others who must abide by the strictures of science, that is, those who practice science-based medicine. This is for the same reason that Bernie Madoff appeared, for many years, to be more successful than other investment advisors with his Ponzi scheme – he wasn’t playing by the rules. Fortunately, he finally got caught because Ponzi schemes are illegal. Unfortunately, making false and misleading claims has been legalized in selling CAM. Yet, I have never seen a CAM proponent or apologist discuss this very obvious aspect of CAM’s popularity. While it might be understandable that those who are profiting from selling CAM (e.g., hospitals and cancer treatment centers) might not want to bring attention to these unappetizing facts, I have never been able to understand why really smart people like Dr. Collins are not able to make this connection to CAM’s supposed popularity.

  13. Scott says:

    @ Jann:

    Another side of that same coin is why the common “health freedom” argument made to support CAM is bogus. Usually we’re talking about not letting purveyors of woo make false claims in order to sell their tripe. Not restricting choice.

    Also interesting is the number of people who will object to suggestions that they not be allowed to lie, on the grounds that it will destroy their business. The more self-aware might notice that they’re basically admitting that spreading false information is a requirement for them to get customers.

  14. nybgrus says:

    Also interesting is the number of people who will object to suggestions that they not be allowed to lie, on the grounds that it will destroy their business. The more self-aware might notice that they’re basically admitting that spreading false information is a requirement for them to get customers.

    I find it completely analogous to any other regulated industry – car manufacture for example.

    Would consumers find it acceptable to have a DSHEA type law for the cars they buy? Would they complain that their “car freedom” has been limited by demanding that certain minimum (science based) engineering and safety standards are met and that the advertisements for various cars are not misleading as to the extent and veracity of their claims? Would people be fine with being sold an ’86 Honda Civic with a Ferrari chassis bolted to the outside at Ferrari prices?

    Yet that is exactly what they accept when it comes to CAM.

  15. nybgrus says:

    Why is prayer any different again?

    As I said above, the fundamental difference I see is that people pray for everything. People don’t get homeopathy for everything.

    I agree it is a fine line, but if the exact same “act” can just as easily be about finding your car keys as health claims then I can only see it muddying the waters in terms of the central claim.

    But that is why going to a faith healing center, or claiming that you are actively seeking health interventions via prayer is different than just ending up in the ER and praying you don’t die, which is what I think many of the highly inflated CAM usage studies tend to include.

    In other words in the morning on my way out thinking “God help me find me keys so I can be on time to work!” is not fundamentally different than 60 minutes later being in a car wreck and thinking “God please help me make it through this and be OK!”

    However, getting pneumonia and thinking “God will cure me, I don’t need a hospital, I need my church” would certainly fall under the “CAM” umbrella, IMO.

  16. pmoran says:

    the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that was finally shown to result in a median survival only one-third of that due to standard-of-care chemotherapy, at the cost of interfering with providing good palliative care to patients.

    There is no evidence that the Gonzales method affects cancer, and it is indeed very arduous for the patient. Nevertheless, we should try and keep our science tight.

    That was NOT a properly randomized study, and as I have pointed out previously, there was strongly suggestive internal evidence of sicker patients within the Gonzales group (50% mortality within about 4 months vs only 5% in the chemotherapy arm). Gonzales claimed that he was being sent sicker patients than the original study design allowed for, and it is likely that this true, through patients misrepresenting their performance status so as to qualify for his treatment free of charge.

    (Randomization had failed abysmally, because nearly all patients preferred Gonzales to chemotherapy.)

  17. Sastra says:

    Color me unsurprised. When Francis Collins was appointed to head the NIH there were a lot of complaints and warnings coming from the gnu atheists: Collins was notorious for trying to merge science and religion in friendly fashion in interviews, websites (Biologos) and books (Belief: Readings on the reasons for faith.) His thinking on the intersection of faith and science had a clear apologetic purpose and was “a jumble of intellectual contradictions.” The concern was that Collins would sooner or later try to use the office as a platform for promoting faith — Christian evangelism or some other form of supernaturalism.

    Is that what’s going on? I don’t know. Collins may not be aware of what he’s doing — and it may be impossible to get him to realize what he’s doing — because he may already be comfortably used to fuzzing the borders of science and religion in his own mind. The director of the NIH is also a popular Christian apologist. He may have changed the title of his talk — but it was apparently still about faith, spirituality, and science. Reaching out to other ways of knowing.

    I see CAM using the same rule book as “spirituality.” Both have strong motivation to co-opt perfectly non-controversial scientific or humanist aspects (pharmacognosy/exercize or values/ feelings of awe) in order to establish themselves as legitimate and significant. After which, sneak in the woo. Or, perhaps, woo sneaks in.

  18. David Gorski says:

    We’ve discussed the Gonzalez study in great detail before.

    First, Kimball:

    http://www.sciencebasedmedicine.org/index.php/gonzalez-regimen-for-cancer-of-the-pancreas-even-worse-than-we-thought-part-i-results/

    http://www.sciencebasedmedicine.org/index.php/gonzalez-regimen-for-cancer-of-the-pancreas-even-worse-than-we-thought-part-ii-loose-ends/

    And me:

    http://www.sciencebasedmedicine.org/index.php/tom-harkin-nccam-health-care-reform-and-a-worse-than-useless-cancer-therapy/

    Quote:

    But it’s even worse than that. Not only was the median survival of patients in the Gonzalez therapy group worse than it was for the standard chemotherapy group, it was three times worse. At one year, 56% of the chemotherapy patients were alive; only 16% of the Gonzalez protocol patients were. But it’s still even worse than that for the Gonzalez therapy. Not only did Gonzalez therapy patients do worse than those receiving standard therapy, but they did worse than the “average” pancreatic cancer patient as determined by the survival curve derived from data from the SEER Database. The most likely reason to explain such a result is that the Gonzalez therapy is not just inferior to gemcitabine but is probably completely biologically inactive against pancreatic cancer. What we are looking when we examine the survival curve for the Gonzalez protocol group is, most likely, indistinguishable from a survival curve of untreated pancreatic cancer…

    While my alter-ego took on Gonzalez’s complaints about the trial:

    http://scienceblogs.com/insolence/2009/09/nicholas_gonzalez_response_to_the_failed.php

  19. pmoran says:

    I am quite sure I have read all that, David , but I still think you are wrong to be exaggerating the significance of the numbers.

    The Gonzales group actually performed considerably worse than even the patients in the SEER data, even though the latter would include “all comers”, while the former were supposed to comprise patients chosen for the likelihood that they would live long enough to complete a meaningful program of either treatment. They should not be dropping like flies in the early months.

    It is a small point, but one that we skeptics would unquestionably go to town on if the position was reversed. The starkly different early trends in the survival graphs cannot be reasonably interpreted any way other than that the groups are not comparable.

    Those interested should look at the survival graph here —

    http://www.sciencebasedmedicine.org/index.php/tom-harkin-nccam-health-care-reform-and-a-worse-than-useless-cancer-therapy/

  20. David Gorski says:

    The conclusion of the study was as clear as day, whether you compared the groups to SEER data or to the Gonzalez group. The very best spin that can be put on it is that the Gonzalez therapy did nothing to alter the natural history of pancreatic cancer; at worst it was harmful to patients. Also, from the study itself, the patients were matched as reasonably as possible, given that the study became open label, “patient’s choice”:

    There were no statistically significant differences at the time of enrollment in age, sex, weight, ECOG performance status, stage of disease, pathology, quality of life, or CA19-9. Bilirubin and albumen were significantly higher in the chemotherapy group, but all values were clinically within normal limits and met eligibility criteria.

    Was the randomization as good as it should have been? Most likely not, but given that a good randomization failed because patients didn’t want to be randomized to chemotherapy it’s hard to see how the situation could be improved. Is it possible there might have been some selection bias? Yes, particularly given that the survival of the treated group was better than expected, although one notes that this also coincides with the addition of gemcitabine to pancreatic cancer therapy, which was probably not reflected in SEER data because gemcitabine is relatively new and SEER data is usually a few years behind the times. However, the reasons for that have been discussed extensively. Was that selection bias enough to make the Gonzalez therapy look any better than no treatment at all? No, as far as I can tell, it was not. As for “exaggerating the significance,” geez, Peter. How? How did I “exaggerate the significance”? I simply stated the conclusion of the study and linked to a more detailed explanation written when the study came out. Another thing to remember is that the SEER database looks at survival of all comers, which means, here in the U.S., that the vast majority of the patients included in the database received treatment of some kind. If a treatment (like the Gonzalez protocol) has no effect whatsoever on the natural history of the disease, then we would expect the survival of patients treated with it to be worse than the SEER database curve. How much worse, I can’t say for sure (probably not a lot worse in the case of pancreatic cancer, admittedly, given how crappy our treatments for advanced disease are). However, the curve in the paper doesn’t strike me as being glaringly outside of what one might expect comparing no treatment with SEER data in that the Gonzalez patients did slightly worse than SEER data.

    In any case, the Gonzalez trial was one of the most unethical studies I’ve ever seen and resulted in the unnecessary suffering of patients. The therapy had no prior plausibility. Of all the things in this article that I expected to be attacked over, this was the thing I least expected: Being criticized about a minor point of the post used to illustrate the unethical nature of certain CAM trials because I didn’t write a treatise about the Gonzalez therapy discussing all the nuances of the results. That’s what links to detailed explanations are for! If the wording of one sentence bothers you so, perhaps I’ll just change it in order to neutralize your picking on minor points, keep the link, and not mention survivals at all. Would that satisfy your need for purity? On second thought, I decided to change the text, not because I think it was wrong, deceptive, or not representative of the results of the trial, but rather to neutralize complaint so that perhaps now you will focus on the actual message of my post.

    I’m sorry if I sound annoyed or defensive, but I am annoyed, as I’ve become quite exasperated with your CAM apologetics over the last two or three years and therefore much less patient than I used to be. In any case, I stand by my previous analyses of the Gonzalez trial.

  21. You’d think that if the NCI/OCCAM & NCCAM were really science based, they would be somewhat embarrassed by the hard core woo of sCAM, much like the skeptical community is embarrassed by the “skeptical” 911 truthers, etc that tend to confuse paranoid conspiracy thinking for skepticism.

    Francis Collins firmly embraces the woo by attending an SIO meeting (as the keynote speaker, no less) that features a program such as the one listed above, and makes statements like the ones he did that show he doesn’t really get it when it comes to sCAM.

    The truth is that in general, sCAM modalities and philosophies do not come from a science based approach or origin, and the attempted application of science is a post hoc process based on the a priori assumption that there is a there there. As long as they continue to put the cart before the horse, they’re doing it wrong.

  22. Rork:
    “Rather than pointing out it’s not CAM according to someone’s definition, why not make more of so-called CAM funding be spent on such useful science? The (underhanded) goal would be to gut CAM research of things actually CAM – only the words would remain, and we will have changed their definition.”

    Because what is likely to happen, is the exact opposite. Including a vast cornucopia under the vast umbrella of CAM (to use a mixed metaphor) lends credibility to everything under that umbrella; that’s exactly why sCAM proponents inflate the usage figures by including modalities like message, diet, nutrition, and natural products in CAM usage figure.

  23. pmoran says:

    I’m sorry if I sound annoyed or defensive, but I am annoyed, as I’ve become quite exasperated with your CAM apologetics over the last two or three years and therefore much less patient than I used to be.

    How is anything I have said “CAM apologetics”?

    I am probably more conscious than you of the exquisite sensitivity of some of our readership to any indication of undue bias against CAM methods, or of excessive drug company allegiance, or of exaggeration of the benefits of conventional medicine. This is on top of genuine concern that we are applying consistent standards of science.

    Your bald statement that the Gonzales “finally” shows chemotherapy to produce 2/3 better survival from inoperable pancreatic cancer at (some unspecified) end point is risky on all counts. It will look to some like a blatant chemotherapy commercial, when the its results are hardly spectacular with this condition. No chemotherapy patient lived longer than 40 months and only 50% survived twelve months.

    When translated into actual numbers it seems 16 patients died within four months in the Gonzales arm and only one in the chemotherapy arm. Are you still satisfied that the groups are as comparable as the authors state?

    .

  24. pmoran “There is no evidence that the Gonzales method affects cancer, and it is indeed very arduous for the patient. Nevertheless, we should try and keep our science tight.
    That was NOT a properly randomized study, and as I have pointed out previously, there was strongly suggestive internal evidence of sicker patients within the Gonzales group (50% mortality within about 4 months vs only 5% in the chemotherapy arm). Gonzales claimed that he was being sent sicker patients than the original study design allowed for, and it is likely that this true, through patients misrepresenting their performance status so as to qualify for his treatment free of charge.”

    Be careful pmoran, you may let actual information and a nuanced understanding get in the way of the message.

  25. David Gorski says:

    Peter, you seem to be missing my point last point (or intentionally ignoring it), which is that the Gonzalez patients did pretty close to exactly as poorly as I would have expected of untreated patients with advanced pancreatic cancer. So, yes, I would not be in the least bit surprised if in a group of untreated patients with advanced pancreatic cancer died early at a much higher rate, particularly given the lack of adequate palliative care in the Gonzalez arm. In any case, let’s reiterate. At enrollment, there were no clinically significant differences between the groups. From the study, one more time:

    There were no statistically significant differences at the time of enrollment in age, sex, weight, ECOG performance status, stage of disease, pathology, quality of life, or CA19-9. Bilirubin and albumen were significantly higher in the chemotherapy group, but all values were clinically within normal limits and met eligibility criteria.

    And yet again:

    At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P< .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P <.01).

    In other words, there isn’t good a priori evidence that the two groups weren’t comparable. So, yes. Yes, I still do think they were roughly comparable. You can disagree all you like, but you haven’t convinced me, and neither has Nicholas Gonzalez, whose arguments you repeat rather closely.

    As for your taking umbrage at my referring to your “CAM apologetics,” I’m sorry, but I’m calling it like I see it. Your language is steeped in CAM apologetics, just in this post. A few examples: “Look like a blatant chemotherapy commercial,” “undue bias against CAM methods,” “excessive drug company allegiance” (really, Peter, that one borders on the pharma shill gambit and it’s evidence that you apparently haven’t read my posts on pharma and device manufacturers’ misdeeds), or “exaggeration of the benefits of conventional medicine.” Tell ya what. Since it’s me doing the writing and I’ll be the one who takes the flack for whatever I write, why don’t you just let me worry about how my words are perceived. I get the message. You’re oh-so-concerned that I’m too “strident” and that I’m somehow hurting the cause. You’ve also just managed to infer that I’m hopelessly biased, a chemotherapy cheerleader, and allied with the drug companies. Yes, I get the message.

  26. pmoran says:

    You can disagree all you like, but you haven’t convinced me, and neither has Nicholas Gonzalez, whose arguments you repeat rather closely.

    Again the attempt to deflect reasonable scientific argument by associating me with “them”. You are oh-so-aware of the ad hominem and the other ploys of CAM, while being oblivious to your own.

    Also, my first words in this exchange were “There is no evidence that the Gonzales method affects cancer — ” but now I am being portrayed as one of the enemy?

    I actually pointed this anomaly out the instant these results were published and long before Gonzales reinforced MY suspicions.

    Do you know of any other chemotherapy study with pancreatic cancer that has shown a 10X benefit for chemotherapy over ANY period? Yet this is what your “this is what happens to untreated patients” theory requires this study to be demonstrating at four months. It probably IS “what happens to untreated patients” but in a group which is almost certainly contaminated with sicker patients than in the chemotherapy group, making your stark comparisons untrustworthy.

    Nor is it likely that, unless the patients were more feeble than expected to start with, the Gonzales method actually reduced the survival in these patients to this degree.

    And what do you think I am expecting of you? I am expecting normally cautious scientific interpretations of the type that you now profess to be making.

    And we should be worrying more about how our rhetoric looks to the unconverted, the unconvinced, and the uncertain. They have to be sure that they are being provided with information they can trust. They will pick up on subtleties that the usual SBM supporter will not.

  27. David Gorski says:

    Also, my first words in this exchange were “There is no evidence that the Gonzales method affects cancer — ” but now I am being portrayed as one of the enemy?

    Not the enemy (although I’m glad you recognize that a quack like Gonzalez is the enemy.) As someone who is falling for the frame of the enemy. I actually did that intentionally to try to shock you into seeing what you were doing, but apparently shock therapy failed. Mea culpa.

    Perhaps you don’t realize how having a doctor like yourself unwittingly promoting the same framing of his therapy and using the same sorts of language as Gonzalez and his supporters looks to the unconvinced. It sounds as though there might be something to the Gonzalez therapy and that perhaps Gonzalez has a point. After all, you say in one sentence that there’s no evidence that Gonzalez’s protocol works, and then you proceed to spend a lot of verbiage trying to rubbish the very study that shows it didn’t work!

    Hey, I know! We need another trial!

    And what do you think I am expecting of you? I am expecting normally cautious scientific interpretations of the type that you now profess to be making.

    Which is exactly what I provided in the link and in stating the finding of the trial, if only you had bothered to click on it:

    http://www.sciencebasedmedicine.org/index.php/tom-harkin-nccam-health-care-reform-and-a-worse-than-useless-cancer-therapy/

    I continue to stand by every word.

    It also occurs to me that there is an aspect to this study that I didn’t emphasize enough. One potential explanation for the difference in survival between the Gonzalez group and the chemotherapy group is that there were sicker patients in the Gonzalez group, as you have repeated ad nauseam. However, there is another possible explanation. At the beginning of the study, the two groups didn’t differ significantly in the clinical parameters adjusted above, suggesting that they were in fact fairly comparable groups. The only evidence you can present suggesting that they weren’t comparable is a high early death rate in the Gonzalez group, and you attribute this to there somehow being sicker patients in the Gonzalez group. But what if the Gonzalez protocol were worse than simply ineffective? What if it were actively harmful? What if it actually hastened the deaths of patients with pancreatic cancer in this trial? That’s certainly not an implausible explanation for the result. Given that the two groups were reasonably well-matched going in to the trial, in fact I’d argue that that explanation is at least as likely, if not considerably more likely, than your explanation. Yet, you did not even consider it as a possibility.

    Where’s your “normally cautious scientific interpretations of the type that you now profess to be making”? You leap to the conclusion that Gonzalez’s patients were sicker based solely on one piece of evidence and don’t even consider alternate possibilities.

  28. pmoran says:

    Now you are not even reading what I say. Of course I had considered the possibility of the Gonzales treatment being actively harmful. Indeed the post that you were last responding to contained this sentence —

    Nor is it likely that, unless the patients were more feeble than expected to start with, the Gonzales method actually reduced the survival in these patients to this degree.

    On my own web site I described this study as “disastrous for the Gonzales method”. There are ways of conveying the implications of the study without going beyond what a small, explicitly non-randomized study can reliably tell us.

    .As I have said, it is a small point, trivial in the grand scheme of things, but others will be quoting this site, and yet others will looking to exploit trivial inconsistencies in how we apply science to clinical studies.

  29. David Gorski says:

    Alright, I missed that. Mea culpa again, but I’m getting tired of answering the same criticism over and over again from you. Admittedly, I skimmed your last response, because I was in a hurry and because it was basically the same ol’ same ol’. I apologize; it was careless, and I was annoyed by your invocation of, in essence, the pharma shill gambit, as I pointed out above.

    However, that being said, I still disagree. You might have considered the possibility that the Gonzalez therapy caused harm, but your basis for rejecting that possibility is unclear. In essence, you blithely dismissed it with a wave of your hand as “unlikely.” Yet there was nothing in the groups that indicated a significant difference in severity of disease, ECOG performance status, or anything else. Moreover, the Gonzalez protocol involves taking up to 150 supplement pills a day, switching to a bizarre diet that involves juicing, meat extracts, and a variety of other things, plus twice a day coffee enemas. Seriously, it is not implausible that twice a day coffee enemas alone could weaken a patient with advanced cancer, particularly when coupled with such a bizarre diet and so many supplements. I don’t consider it unlikely or implausible at all that such a regimen might have hastened the demise of pancreatic cancer patients.

    I’m also curious why, if this all is such a “small point, trivial in the grand scheme of things,” you’ve spent so much verbiage attacking me about it. Your actions belie your words. It is quite obvious to me that you don’t consider this point trivial at all. If you did, you wouldn’t have taken so much time and effort to castigate me for what you seem to think are my sins against science. In fact, you completely hijacked the thread over what you refer to as a “trivial” point while completely ignoring the main thrust of the post.

  30. pmoran says:

    I’m also curious why, if this all is such a “small point, trivial in the grand scheme of things,” you’ve spent so much verbiage attacking me about it.

    I have made the same comment when other authors have discussed this study here. Others can decide who chose to bring my perceived personal failings into the discussion.

  31. nybgrus says:

    And we should be worrying more about how our rhetoric looks to the unconverted, the unconvinced, and the uncertain. They have to be sure that they are being provided with information they can trust. They will pick up on subtleties that the usual SBM supporter will not…. As I have said, it is a small point, trivial in the grand scheme of things, but others will be quoting this site, and yet others will looking to exploit trivial inconsistencies in how we apply science to clinical studies.

    And the dogged discussion of minutiae simply for the pure pedantry of it is a better tack? To be so clamped down as to refuse to reasonably extrapolate anything that isn’t certain enough by… well… I actually have a lot of trouble figuring out what criteria you actually use. Certainly not consistent criteria, anyway. And definitely not consistent language.

  32. David Gorski says:

    Indeed they can, which is fine with me. After all, none of this changes the fact that this thread was completely derailed based on what you yourself characterize as a “trivial” point in the “grand scheme of things” directed at what was a single sentence in my original opening paragraph.

  33. pmoran says:

    (To recap the scientific issues —

    There is no question whatsoever that if the study was showing the Gonzales method to be superior or equivalent we would be grumbling away about this not being properly randomized study, and we would have examined the data closely enough to pick up this excessive early mortality.

    We would also not accept as conclusive the statement that there was “no statistically significant difference” between any of the measures comparing these two small non-randomised groups. Unconscious bias in the researchers or patients misrepresenting their status could produce small non-significant differences in some of the parameters, adding up to a poorer overall prognosis for a condition that can have a very rapidly downhill clinical course once decline commences.)

    But why bother, if the end is much the same? Gee, I don’t know. I thought one of the objectives of this blog was to refine interpretation of clinical studies. Perhaps the reason this anomaly stood out for me alone is that there was a very similar one undermining linus Pauling’s studies on Hoffer’s megavitamain-treated cancer patients showing much better survival for his treatment in purportedly similar groups of patients.

    It is something to look out for in this kind of study.

    We have also set ourselves up as guardians of scientific truths. It is not clear that this permits much looseness within our own claims.

    I am not even saying that my view is absolutely correct, merely that there are reasons for caution as to what precisely the the study is showing for Gaonzales relative to the other groups.

    Cancer patients themselves would be more interested in knowing that no patient in either group lived beyond 40 months and no patient in the Gonzales group seems to have gone into remission (otherwise we would have heard).

  34. David Gorski says:

    I actually have a lot of trouble figuring out what criteria you actually use. Certainly not consistent criteria, anyway. And definitely not consistent language.

    I think you’ve nailed down a point. Peter has basically perseverated relentlessly about this issue; it’s clearly very, very important to him. Now, I’ll admit as much as anyone that his criticism took me by surprise. Of all the things I expected this article to be criticized about (and there were several), a quickie line in the introduction about the disaster that is the Gonzalez trial wasn’t one of them. I was even more surprised by the vociferousness of the criticism, which basically painted me as dogmatic, close-minded, and, worst of all, a sloppy scientist. Then came the CAM-friendly language: “Look like a blatant chemotherapy commercial,” “undue bias against CAM methods,” “excessive drug company allegiance,” or “exaggeration of the benefits of conventional medicine.” The last one really puzzled me, given that I have repeatedly pointed out elsewhere how modest the benefits are due to pretty much every chemotherapy regimen we have for pancreatic cancer, and the cracks about a “blatant chemotherapy commercial” and “drug company allegiance” struck me as a not-so-thinly disguised pharma shill gambit, which, I admit, ticked me off a bit. It’s the sort of language Peter has used time and time again on this blog, too, which perhaps added to its potential to annoy.

    Now, I’ll take my portion of the blame. A thread can’t be hijacked by minutiae like this if other participants allow it, and I was in essence the only other participant. So it’s my fault as well. If I had simply said, “We’re going to have to agree to disagree on this point” and let it drop, then that would have been that. So that’s what I’m going to do now. Better late than never, although it’s probably too late to salvage any fruitful discussion about the actual point of this post from this thread.

  35. pmoran says:

    David, this exchange escalated because you initially failed to respond to my admitted “small point”, merely condescendingly directing me to material that I was already very familiar with. So I sent another post simply restating my case.

    You only then responded directly, but with expressed “annoyance” and an entirely inappropriate and irrelevant reference to my supposed past “CAM apologetics”. Was I supposed to take that silently?

    So yes, you are entirely personally responsible for the supposed hijacking of this thread.

  36. pmoran says:

    I was even more surprised by the vociferousness of the criticism, which basically painted me as dogmatic, close-minded, and, worst of all, a sloppy scientist. Then came the CAM-friendly language: “Look like a blatant chemotherapy commercial,” “undue bias against CAM methods,” “excessive drug company allegiance,” or “exaggeration of the benefits of conventional medicine.”

    You know, David, you are as full of ploys and ad hominem as those you frequently accuse of the same. One of yours is to frame selected comments in as unfavourable a light as they could possibly be interpreted.

    I am compelled to invite everyone to read my comments and see if David’s account of them rings true.

    It was explicit with the above phrases that I was referring to the public perceptions of those with heightened sensitivity to certain matters.

    That is what we have to counter. We are in the business of trying to regain public trust. All our “opponents” have to do is to keep on sustainiing doubt. They have pateint desperation on their side.

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