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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

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