The Ongoing Problem with the National Center for Complementary and Alternative

In spite of statements to the contrary by its director, the NCCAM continues to fund and promote pseudoscience. Political pressures and the Centers charter would seem to make this inevitable. Ethics and the public interest are compromised. KIMBALL C. ATWOOD IV, M.D.

he National Center for Complementary and Alternative Medicine (NCCAM) was established in T1998, seven years after the creation of its predecessor, the Office of Alternative Medicine (OAM). The OAM had been formed not because of any medical or scientific need, but because Iowa senator Tom Harkin and former Iowa represen- tative Berkeley Bedell believed in implausible health claims as a result of their own experiences. Bedell thought that "Naessens Serum" had cured his prostate cancer and that cow colostrum had cured his Lyme disease (Jarvis 1996). He rec- ommended "alternative medicine" to his friend Harkin, who subsequently came to believe that bee pollen had cured his hay fever (Marshall 1994).

SKEPTICAL INQUIRER Seplember/October 2003 23 Political wrangling, but little science, marked the history of diis adulteration was discovered, the NCCAM had been spon- the organization throughout the 1990s (Gorski 2001). soring four studies of PC-SPES. The studies had been justified Although the OAM was officially a part of the National by preliminary data suggesting that PC-SPES may be effective Institutes of Health (NIH), it was managed more by for the treatment of prostate cancer. That effect, however, has "Harkinites" than by scientists (Marshall 1994; Satel and now been explained by the presence of diethylstilbestrol and Taranto 1996). Science magazine recounted a 1993 congres- indomethacin (Sovak et al. 2002). Nevertheless, after a brief sional hearing held by Harkin, with Bedell as a witness: pause the NCCAM intends to resume three of die studies "because of die promising data from the early studies of PC NIH, Bedell said, should hire staffers to locate anyone who claims to have a successful therapy, search the files, a n d "just sim- SPES" (NCCAM Web site 2002a). ply find out whether what he claims is correct," Straus warned of "some herbal . . . that interfere wirJi the metabolism of drugs used to treat cancer or AIDS" [Subsequent to the hearing] Bedell brushed aside questions about how his field studies could be designed to avoid bias. This is a (Straus 2002). By this he meant, mainly, St. John's wort. But technical detail, Bedell said, and "I'm not a scientist." But he St. John's wort has for years been recommended as a treatment insisted at the hearing—and still insists—that field s t u d i e s can be for the HIV by the naturopathic Bastyr University AIDS done quickly and easily, without fancy statistics or double- Research Center, funded by die OAM/NCCAM since 1994 blinded controls (Marshall 1994). (BUARC Web site 2002). The Bastyr Web site does not men- tion die danger of mixing St. John's wort with HIV protease inhibitors, although that Political wrangling, but little science, fact had been known since 2000 (Piscitelli marked the history of the organization et al. 2000). How many people carrying the HIV may have developed AIDS or relapses throughout the 1990s. Although the OAM because of such promotion is a mystery, but was officially a part of the National Institutes there is no indication that anyone at Bastyr or the NCCAM is wondering. of Health (NIH), it was managed more The director of the Bastyr University by politicians than by scientists. AIDS Research Center is naturopath Leanna Standish. She was a member of the NCCAM advisory council from The creation of the NCCAM as an "NIH Center" in 1998, 1999-2001. She is the Principal Investigator of an NCCAM- followed by the appointment of Stephen Straus as its director sponsored clinical trial to study "Gallic in hyperlipidcmia in 1999, marked a noticeable change. Straus is the first direc- caused by HAART [highly active anti-retroviral therapyl." But tor of the OAM/NCCAM to have legitimate qualifications as garlic is another substance that reduces blood levels of lifesav- a biomedical scientist. He promised "to explore CAM healing ing HAART agents (Piscitelli et al. 2002), a fact that is men- practices in the context of rigorous science, to educate and tioned in neither the NCCAM nor the Bastyr descriptions of train CAM researchers and to disseminate authoritative infor- the trial. mation about CAM to the public" (Straus 1999). Three years Standish is the lead author of a chapter in the major text- later he felt confident enough to tell The Scientist, regarding book of naturopathy that recommends more than 100 "thera- scientific opinions of die NCCAM, "I think there's very little peutic suggestions" for HIV infection and its complications skepticism left" (Russo and Maher 2002). (Standish et al. 1999). The authors state that these treatments This article argues that in spite of Dr. Straus's convictions, constitute "comprehensive care that is concordant with several the NCCAM continues to be committed more to pseudo- naturopathic principles" and that the program is being studied science and CAM advocacy than to rigorous science. "through a three-year cooperative agreement grant with the NIH's Office of Alternative Medicine" (now the NCCAM). In Pointless Research and Dangerous Promotions addition to St. John's wort and garlic, some of the recom- Director Straus, referring to NCCAM-sponsored research, mended treatments are "acupuncture detoxification auricular recendy wrote, "Some people believe diat any such undertaking program," whole-body hyperthermia, "adrenal glandular," is a pointless exercise" (Straus 2002). That is correct, and some homeopathy, "cranioelectrical stimulation," digestive enzymes, of the reasons for this were evident in his short article. He noted and colloidal silver, a toxic heavy metal that the FDA has that the herbal mixture PC-SPES was recendy found to be adul- declared useless for any medicinal purpose. terated by prescription drugs. He did not mention that when The audiors offer numerous references to support the use of diese methods, but all are inadequate or irrelevant. The cita- Dr. Atwood is an anesthesiologist at the Newton-Wellesley tion for colloidal silver, for example, is a report of its use as a Hospital in Newton, Massachusetts. He is Assistant Clinical preservative. The authors admit, near die end of their twenty- Professor at the Tufts University School of Medicine and page chapter, that proof of their assertions is lacking. Contributing Editor of the Scientific Review of Alternative Nevertheless, on the first page they have promised diat die Medicine. E-mail: [email protected]. program "should guide die physician is assisting patients in

2 4 September/October 2003 SKEPTICAL INQUIRER optimizing their health, slowing disease progression, improv- "Biofield," according to an OAM publication, is defined as "'a ing quality of life, and possibly improving immune function." massless field' dial: (a) is not necessarily electromagnetic, (b) surrounds and permeates living bodies, (c) affects die body, and Implausible Claims and Unacknowledged (d) possibly is related to qV (Raso 1997). According to the Scientific Fraud NCCAM Web site, "This Center facilitates and integrates According to the Bastyr Web site, die NCCAM also sponsors research on die effects of low energy fields. The research is a study of "Distant Healing Therapy in HIV/AIDS." focused on developing standardized bioassays (cellular biology) Investigators include Standish and the late Elisabeth Targ, pre- and psychophysiological and biophysical markers of biofield viously the subject of a SKEPTICAL INQUIRER column by effects, and on die application of the markers developed to mea- Martin Gardner (March/April 2001). "Distant Healing" in sure outcomes in die recovery of surgical patients." diis case means that anonymous people pray, from a distance, for patients who are unaware of it. The study is to "extend pre- The NCCAM funds Elisabeth Targ's distant liminary work," by which is meant Targ's healing studies, presumably 1998 study, famous in CAM circles (Sicher et al. 1998). The NCCAM also funds justified by her 1998 study. another of Targ's distant healing studies, That study, however, has now been presumably also justified by her 1998 study. That study, however, has now been revealed revealed as a scientific fraud. as a scientific fraud (Bronson 2002). At the time of this writing neither the Bastyr Web site nor the NCCAM has acknowledged this, and the The center's Principal Investigator is psychologist Gary NCCAM apparently has no plans to discontinue the now- Schwartz, a colleague of alternative medicine guru Andrew baseless current studies. Weil at the University of Arizona. Schwartz has published a Anodier of Standish's studies, sponsored by the NCCAM, book in which he claims to have shown scientifically diat "con- is "Transfer of Neural Energy." It proposes to find "that visu- sciousness continues after ally evoked potentials generated in one human brain (Subject death" and that mediums, A) by photostimulation can generate a correlated EEG signal in the brain of another human subject (Subject B) who is located at a distance (14.5 meters) and is not visually stim- ulated" (BURP 2003). In other words, it hypothesizes the recurrent paranor- mal claims of thought transmis- sion and "," both of which are implausible and never demonstrated despite thousands of attempts (Kurtz 1985). Standish was an original member ot the recently formed Institute of Medicine (IOM) panel on "Use of Complementary and Alternative Medicine by the American Public,' sponsored by a $1 million grant from the NCCAM (IOM Web site 2003). This panel will not consider die validity of CAM claims, but seems intended to pro- vide justification for the NCCAM's con- tinued existence.

Research Centers, More Implausible Claims, and "Integrative Medicine" Centers The NCCAM funds several "research centers," among which is Bastyr University. Another is the Center for Frontier Medicine in Biofield Science.

SKEPTICAL INQUIRER Stptember/October 2003 25 (CAM Director 2001). Straus himself acknowledged this in including John Edward, can communicate with the dead a recent interview: "people at major universities . . . become (Schwartz 2002). A recent SI critique of Schwartz's methods stunned thinking that we should be an easy take" (Russo found them to be flawed in the most elementary of ways, such and Maher 2002). Some in academic medicine are undoubt- diat no competent scientist could take his conclusions seri- edly afraid that criticism of the NCCAM might displease ously (Hyman 2003). Sen. Harkin who, as Chairman and/or Ranking Member of Another NCCAM-sponsored research center will study "the the Labor, Health and Human Services, and Education effect of Therapeutic Touch on bone metabolism and on fibrob- Appropriations Subcommittee, can influence the budget of last biology,... on bone metabolism in postmenopausal women the entire NIH. This could explain why, according to with wrist fractures and ... the effect of healing touch on Straus, "our sister institutes have picked up" several grant immune function in advanced cervical cancer" (NCCAM proposals that the NCCAM was unable to fund (Russo and Web site 2002b). Therapeutic Touch consists of the waving of Maher 2002). hands several inches from a patient. Its putative basis is a manip- Straus opined that this must mean that the proposals ulate "human energy field" that can be detected by practition- weren't "crap," but that is not the only possible explanation. A companion piece to this article shows, in the case of Rep. Dan Burton and the National Heart, Lung, and Blood Institute, how a powerful ideologue can dictate the research agenda of an NIH affiliate Much of the research agenda of the NCCAM (Atwood 2003). There are also precedents is either so implausible as to not warrant for Sen. Harkin using his position to wres- spending public monies or has already tle control of medical research away from scientists. In 1994, according to the been disproved in other settings. National Council Against Health Fraud, resigning OAM Director Joseph Jacobs "complained that Sen. Harkin was holding the entire NIH budget hostage" until Jacobs placed three of Harkin's choices, ers but not by any scientific instrument (Atwood 2002b). In among them Berkeley Bedell, on the OAM advisory panel experiments, however, Therapeutic Touch practitioners have (NCAHF 1994). At the 1993 hearing reported by Science, failed to detect the "energy field" when denied visual cues (Rosa "Bedell ... complained that the NCI wasn't moving fast et al. 1998). enough to validate antineoplaston therapy. Harkin responded Much of the rest of die research agenda of the NCCAM, that he would 'get their attention real fast. I have been around such as "cranial osteopathy" for otitis media, "In Vitro here eighteen years, and I have figured out how to use die Investigation of Distant Qi Gong," "Gonzalez Therapy" for purse strings'" (Marshall 1994). cancer of the pancreas (coffee enemas, pancreatic enzymes, All of this has resulted in the establishment of a cadre of hundreds of daily "dietary supplement" pills, and hair analy- academics who have come to rely on NCCAM funds or who ses), magnets for various purposes, acupuncture for diarrhea in otherwise defend the NCCAM's existence, with little regard HIV patients, and oral shark cartilage for cancer, is either so for the scientific issues raised here. Thus many physicians who implausible as to not warrant spending public monies or has have not taken die time to consider CAM (and many mem- already been disproved in other settings. Some trials appear to bers of the public) are led to believe that CAM claims are likely employ more than one method in the same study group, to be valid and that the NCCAM project is a noble one. ensuring that even if an effect exists there will be no way to tell what caused it (NCCAM Web site 2003). Human Studies Ethics and CAM A few of the trials and research centers seem, on their face, Clinical trials of CAM methods pose particular ethical prob- to be legitimate. Examples of these are die Glucosamine/ lems. Drawing from the primary ethics literature of the past Chondroitin Arthritis Intervention Trial and die NCCAM's fifty years, Ezekiel Emanuel and colleagues have proposed own Division of Intramural Research. seven universal criteria for determining if a human study is Several grants go to medical schools for die purpose of ethical: value, scientific validity, fair subject selection, favor- establishing "integrative medicine" centers, which begs the able risk-benefit ratio, independent review by unaffiliated question of why this should be done in the absence of evidence individuals, informed consent, and respect for enrolled sub- diat "integrative medicine" works. jects (Emanuel et al. 2000). All criteria must be met in order to make such research ethical. Cynicism and Fear Highly implausible or impossible methods, such as home- Some academic physicians view the NCCAM cynically, as opathy, craniosacral therapy, "psychic (distant) healing," simply another opportunity to get scarce grant money Therapeutic Touch, EDTA chelation for atherosclerosis, die

2 6 Seplember/Octobef 2003 SKEPTICAL INQUIRER chiropractic "subluxation theory" and many other CAM lated to the purposes of the research, be the primary basis for claims are what Emanuel and colleagues refer to as "trifling determining the groups and individuals that will be recruited hypotheses." Human studies of such methods are, a priori, and enrolled" (Emanuel et al. 2000). unethical, quite apart from any political impetus to conduct The Office for Human Research Protections recently cited them. This is both because of the exploitation of subjects for Columbia University for failure to describe serious risks on the questions that lack "scientific or clinical value" and because such research is a waste of resources: "Comparing relative value is integral to determinations of funding priorities when allocating limited funds among alternative research propos- Human studies of such methods als" (Emanuel et al. 2000). In particular, one might add, if those funds are public. are, a priori, unethical, quite apart from Thus the current federal allocation of any political impetus to conduct them. $110 million per year for the NCCAM might be weighed against the $5 million This is both because of the exploitation per year allocated for research on spinal of subjects for questions that lack muscular atrophy, a devastating child- hood disease that some scientists believe "scientific or clinical value" and because would be on the verge of a therapeutic such research is a waste of resources. breakthrough but for want of adequate funding (Cohen 2002). These ethical arguments are not refuted by the contention that a significant fraction of the population may wish such studies to be done, or even by the argument that demonstrating such consent form of its "Gonzalez" protocol for cancer of the pan- methods ineffective will benefit society. These are the usual creas, funded by the NCCAM (OHRP 2002). The study pro- arguments favoring the existence of the NCCAM and CAM poses to compare the arduous "Gonzalez" method, which is research programs in academic medicine, and are often made devoid of biological rationale, to gemcitabine, an agent even by skeptics. But such contentions arc irrelevant to the eth- acknowledged by the investigators to effect "a slight prolonga- ical issues and as such are expressly discouraged, as a basis for die tion of life and a significant improvement in . . . quality of Institutional Review Board (IRB) approval of NIH-sponsored life." Nevertheless, a letter from Columbia to prospective sub- study proposals, by the Code of Federal Regulations (CFR jects states, "it is not known at the present time which treat- 2001): "The IRB should not consider possible long-range ment approach is best [sic] overall" (Chabot 1999). The claim effects of applying knowledge gained in the research (for exam- of clinical equipoise, or uncertainty in the expert medical com- ple, the possible effects of the research on public policy) as munity over which treatment is superior—necessary to render among those research risks that fall within the purview of its a comparison trial ethical—is not supported by the facts responsibility" (CFR §46.111). (Freedman 1987). Nor does the virtual certainty that some subjects would The proposed Trial to Assess Chelation Therapy in CAD use an implausible therapy, even in the absence of a clinical will likely violate several ethical requirements, including lack trial, render such a trial ethical: "the IRB should consider of scientific validity, lack of value, biased subject selection, and only those risks and benefits that may result from the unfavorable risk-benefit ratio. It will be unlikely to recruit sub- research" (as distinguished from risks and benefits of thera- jects—other than those already predisposed to such treat- pies subjects would receive even if not participating in the ment—unless it presents dishonest consent information research) (CFR §46.116). (Atwood 2003). Plausibility also figures in informed consent language and subject selection. How many subjects who are not wedded to Advisory Councils "alternative medicine" would be likely to join a study that There are two councils charged with advising the director of independent reviewers rate as unlikely to yield any useful the NCCAM on matters related to research funding and clin- results, or in which the risks are stated to outweigh the poten- ical trials: the National Advisory Council for Complementary tial benefits? Are informed consents for such studies honest? In and Alternative Medicine (NACCAM) and the Cancer at least one case cited in the following paragraph, the answer is Advisory Panel for Complementary and Alternative Medicine "no." Nor may subjects who prefer "alternative" methods be (CAPCAM). It might be expected that the membership of preferentially chosen for such research even if they seek this, these councils reflects the Center's professed commitment to because "fair subject selection requires that the scientific goals the rigorous, skeptical inquiry of "complementary and alterna- of the study, not vulnerability, privilege, or other factors unre- tive" methods. The director, however, has no formal role in

SKEPTICAL INQUIRER September/October 2003 27 selecting the council members. The members of the NAC- Perhaps the strangest part of the press conference consisted CAM are appointed by the Secretary for Health and Human of brief statements by individual members of the editorial Services, with these stipulations: "Of the eighteen appointed review board of what they saw as the most important issues members, twelve shall be selected from among the leading rep- for the Office of Alternative Medicine. One insisted that the number-one health problem in the United States is resentatives ... of die health and scientific disciplines in the magnesium deficiency; another was convinced that the area of complementary and alternative medicine. Nine of the expanded use of acupuncture could revolutionize medicine; twelve shall include practitioners licensed in one or more of and so it went around the table, with each touting his or her die major systems with which the Center is involved" preferred therapy. But there was no sense of conflict or (NCCAM Charter 2000). The members of the CAPCAM are rivalry. As each spoke, the others would nod in agreement. appointed by the director of the NIH, but widi the require- The purpose of the OAM, I began to realize, was to demon- ment that "of the fifteen members, eleven shall be nonfederal," strate that these disparate therapies all work. It was my first including the Chair, and "nonfederal members will be selected glimpse of what holds alternative medicine together: there is based on their knowledge and expertise in the fields of com- no internal dissent in a community that feels itself besieged plementary and alternative therapeutic cancer treatments" from the outside. (CAPCAM Charter 2002). Conflicts of Interest Thus it can be predicted that the councils will be biased, prima facie, in favor of the very methods diat die Center is Many NCCAM grant recipients have conflicts of intetest charged to submit to skeptical scrutiny. An examination of the regarding the Center. Several grant recipients are or have been rosters of the two councils supports this prediction. Among members of the NCCAM Advisory Council or the Cancer the NACCAM members in the past three years were Standish Advisory Panel. Several members of the "Expert Panel to and two other naturopaths. In 2000 one of them, Anna Assess NCCAM Research Centers," including the Chairman, Macintosh, recommended "Gerson Therapy" for cancer and are either grant recipients or are affiliated with institutions that multiple sclerosis (NCNM Web site 2000). This is a regimen receive NCCAM grants (Expert Panel 2002). Several members of "detoxification" with coffee enemas and a diet including of the recently formed IOM panel on "Use of Complementary huge quantities of juices made from fruits, vegetables, and raw and Alternative Medicine by the American Public," itself spon- calf's liver. The National Cancer Institute had evaluated sored by the NCCAM, are recipients of NCCAM grants Gerson's claims in 1947 and again in 1959, and found them (IOM Web site 2003). No member of that panel has demon- to be baseless (Barrett and Herbert 2001). strated expertise in the rigorous evaluation of CAM methods. The third naturopath on the NACCAM is Konrad Kail, Conclusion who explains "patient-centered care" this way: "If I see a patient who has pain in his arms because his neck is out of Straus has written that the NCCAM "was created to foster and alignment, I explain to them that we can do spinal adjust- build a research enterprise that subjects complementary and ments, acupuncture, homeopathy, or we can do all three. Then alternative medicine to open-minded, hypodiesis-driven investi- I wait for their [sic] choice" (Morton and Morton 1997). gation" (Straus 2002). That is inaccurate. The NCCAM was cre- Another recent member of the NACCAM is Marilyn J. ated by a few advocates who believed in implausible or disproved Schlitz, reported by skeptic Dr. Tim Gorski to be "an astral health claims, including laetrile, and who felt that the scientific voyager 'remote viewer' who was praised by Russell Targ for "establishment" was unfairly suppressing rhem (Gorski 2001; having 'achieved the greatest statistical significance of any Atwood 2002a; Sampson 2002). As such, the Center's role has remote-viewing experiment so far conducted' in exploring been more one of advocacy than of science. Calls for its abolition tourist sites in Rome from her home in Detroit, Michigan" have been reasoned and comprehensive (Stalker 1995; Science (Gorski 2001). Schlitz is a co-investigator with Standish in the 1997; Halperin 1998; Sampson 2002). aforementioned "transfer of neural energy" study. After more than ten years and $200 million, OAM/ O n die CAPCAM still sits Ralph Moss, one of the original NCCAM-sponsored research has not demonstrated efficacy for "Harkinites." His Cancer Chronicles newsletter has suggested any CAM method, nor has the Center informed die public diat that homeopathy and other implausible treatments can cure any method is useless (Green 2001). It continues to fund and cancer (Moss 1995). He has also accused the Mayo clinic of promote pseudoscience. It continues to be influenced by power- being "fraudulent" (Moss 1993) because of its study diat ful ideologues. demonstrated the ineffectiveness of laetrile (Moertel et al. The problem with so-called Complementary and Alternative 1982). This exposes the fallacy of the social usefulness of stud- Medicine, in a nutshell, is that it is an assortment of implausible, ies that disprove sectarian methods. dishonest, expensive, and sometimes dangerous claims that are In considering the rosters of the two councils, one is exuberandy promoted to a scientifically naive public. The reminded of physicist Robert Park's account of a 1995 Senate NCCAM, so far, has not been part of the solution. press conference announcing the release of Alternative Acknowledgments Medicine: Expanding Medical Horizons, the report of a work- shop sponsored by the Office of Alternative Medicine (OAM The author is indebted to Wallace Sampson and Elizabeth Woecknet workshop 1992). The press conference was hosted by Sen. for invaluable discussions and for tips on hard-to-find sources related Harkin. According to Park (2000): to the content of this article.

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