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The Ongoing Problem with the National Center for Complementary and Alternative Medicine

Article

Kimball C. Atwood

Volume 27.5, September / October 2003

In spite of statements to the contrary by its director, the NCCAM continues to fund and promote pseudoscience. Political pressures and the Center’s charter would seem to make this inevitable. Ethics and the public interest are compromised.

The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998, 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 representative 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 recommended “alternative medicine” to his friend Harkin, who subsequently came to believe that bee pollen had cured his hay fever (Marshall 1994).

Political wrangling, but little science, marked the history of the organization throughout the 1990s (Gorski 2001). Although the OAM was officially a part of the National Institutes of Health (NIH), it was managed more by “Harkinites” than by scientists (Marshall 1994; Satel and Taranto 1996). Science magazine recounted a 1993 congressional hearing held by Harkin, with Bedell as a witness:

NIH, Bedell said, should hire staffers to locate anyone who claims to have a successful therapy, search the files, and “just simply find out whether what he claims is correct.”

[Subsequent to the hearing] Bedell brushed aside questions about how his field studies could be designed to avoid bias. This is a technical detail, Bedell said, and “I'm not a scientist.” But he insisted at the hearing—and still insists—that field studies can be done quickly and easily, without fancy statistics or double-blinded controls (Marshall 1994).

The creation of the NCCAM as an “NIH Center” in 1998, followed by the appointment of Stephen Straus as its director in 1999, marked a noticeable change. Straus is the first director of the OAM/NCCAM to have legitimate qualifications as a biomedical scientist. He promised “to explore CAM healing practices in the context of rigorous science, to educate and train CAM researchers and to disseminate authoritative information about CAM to the public” (Straus 1999). Three years later he felt confident enough to tell The Scientist, regarding scientific opinions of the NCCAM, “I think there’s very little skepticism left” (Russo and Maher 2002).

This article argues that in spite of Dr. Straus’s convictions, the NCCAM continues to be committed more to pseudoscience and CAM advocacy than to rigorous science.

Pointless Research and Dangerous Promotions

Director Straus, referring to NCCAM-sponsored research, recently wrote, "Some people believe that any such undertaking is a pointless exercise” (Straus 2002). That is correct, and some of the reasons for this were evident in his short article. He noted that the herbal mixture PC-SPES was recently found to be adulterated by prescription drugs. He did not mention that when this adulteration was discovered, the NCCAM had been sponsoring four studies of PC-SPES. The studies had been justified by preliminary data suggesting that PC-SPES may be effective for the treatment of prostate cancer. That effect, however, has now been explained by the presence of diethylstilbestrol and indomethacin (Sovak et al. 2002). Nevertheless, after a brief pause the NCCAM intends to resume three of the studies “because of the promising data from the early studies of PC SPES” (NCCAM Web site 2002a).

Straus warned of “some herbal medicines . . . that interfere with the metabolism of drugs used to treat cancer or AIDS” (Straus 2002). By this he meant, mainly, St. John’s wort. But St. John’s wort has for years been recommended as a treatment for the HIV by the naturopathic Bastyr University AIDS Research Center, funded by the OAM/NCCAM since 1994 (BUARC Web site 2002). The Bastyr Web site does not mention the danger of mixing St. John’s wort with HIV protease inhibitors, although that fact had been known since 2000 (Piscitelli et al. 2000). How many people carrying the HIV may have developed AIDS or relapses because of such promotion is a mystery, but there is no indication that anyone at Bastyr or the NCCAM is wondering.

The director of the Bastyr University AIDS Research Center is naturopath Leanna Standish. She was a member of the NCCAM advisory council from 1999-2001. She is the Principal Investigator of an NCCAM-sponsored clinical trial to study “Garlic in hyperlipidemia caused by HAART [highly active anti-retroviral therapy].” But garlic is another substance that reduces blood levels of lifesaving HAART agents (Piscitelli et al. 2002), a fact that is mentioned in neither the NCCAM nor the Bastyr descriptions of the trial.

Standish is the lead author of a chapter in the major textbook of naturopathy that recommends more than 100 “therapeutic suggestions” for HIV infection and its complications (Standish et al. 1999). The authors state that these treatments constitute “comprehensive care that is concordant with several naturopathic principles” and that the program is being studied “through a three-year cooperative agreement grant with the NIH’s Office of Alternative Medicine” (now the NCCAM). In addition to St. John’s wort and garlic, some of the recommended treatments are "acupuncture detoxification auricular program,” whole-body hyperthermia, "adrenal glandular,” homeopathy, “cranioelectrical stimulation,” digestive enzymes, and colloidal silver, a toxic heavy metal that the FDA has declared useless for any medicinal purpose.

The authors offer numerous references to support the use of these methods, but all are inadequate or irrelevant. The citation for colloidal silver, for example, is a report of its use as a preservative. The authors admit, near the end of their twenty-page chapter, that proof of their assertions is lacking. Nevertheless, on the first page they have promised that the program “should guide the physician is assisting patients in optimizing their health, slowing disease progression, improving quality of life, and possibly improving immune function.”

Implausible Claims and Unacknowledged Scientific Fraud

According to the Bastyr Web site, the NCCAM also sponsors a study of "Distant Healing Therapy in HIV/AIDS.” Investigators include Standish and the late Elisabeth Targ, previously the subject of a Skeptical Inquirer column by Martin Gardner (March/April 2001). “Distant Healing” in this case means that anonymous people pray, from a distance, for patients who are unaware of it. The study is to “extend preliminary work,” by which is meant Targ’s 1998 study, famous in CAM circles (Sicher et al. 1998). The NCCAM also funds another of Targ’s distant healing studies, presumably also justified by her 1998 study. That study, however, has now been revealed 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 NCCAM apparently has no plans to discontinue the now-baseless current studies.

Another of Standish’s studies, sponsored by the NCCAM, is “Transfer of Neural Energy.” It proposes to find “that visually evoked potentials generated in one human brain (Subject 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 stimulated” (BURP 2003). In other words, it hypothesizes the recurrent paranormal claims of thought transmission and “remote viewing,” both of which are implausible and never demonstrated despite thousands of attempts (Kurtz 1985).

Standish was an original member of 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 the validity of CAM claims, but seems intended to provide justification for the NCCAM’s continued 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. “Biofield,” according to an OAM publication, is defined as “`a massless field' that: (a) is not necessarily electromagnetic, (b) surrounds and permeates living bodies, (c) affects the body, and (d) possibly is related to qi” (Raso 1997). According to the NCCAM Web site, "This Center facilitates and integrates research on the effects of low energy fields. The research is focused on developing standardized bioassays (cellular biology) and psychophysiological and biophysical markers of biofield effects, and on the application of the markers developed to measure outcomes in the recovery of surgical patients.”

The center’s Principal Investigator is psychologist Gary Schwartz, a colleague of alternative medicine guru Andrew Weil at the University of Arizona. Schwartz has published a book in which he claims to have shown scientifically that “consciousness continues after death” and that mediums, including John Edward, can communicate with the dead (Schwartz 2002). A recent SI critique of Schwartz’s methods found them to be flawed in the most elementary of ways, such that no competent scientist could take his conclusions seriously (Hyman 2003).

Another NCCAM-sponsored research center will study “the effect of Therapeutic Touch on bone metabolism and on fibroblast biology, . . . on bone metabolism in postmenopausal women with wrist fractures and . . . the effect of healing touch on immune function in advanced cervical cancer” (NCCAM Web site 2002b). Therapeutic Touch consists of the waving of hands several inches from a patient. Its putative basis is a manipulable “human energy field” that can be detected by practitioners but not by any scientific instrument (Atwood 2002b). In experiments, however, Therapeutic Touch practitioners have failed to detect the “energy field” when denied visual cues (Rosa et al. 1998).

Much of the rest of the research agenda of the NCCAM, such as “cranial osteopathy” for otitis media, “In Vitro Investigation of Distant Qi Gong,” “Gonzalez Therapy” for cancer of the pancreas (coffee enemas, pancreatic enzymes, hundreds of daily “dietary supplement” pills, and hair analyses), magnets for various purposes, acupuncture for diarrhea in HIV patients, and oral shark cartilage for cancer, is either so implausible as to not warrant spending public monies or has already been disproved in other settings. Some trials appear to employ more than one method in the same study group, ensuring that even if an effect exists there will be no way to tell what caused it (NCCAM Web site 2003).

A few of the trials and research centers seem, on their face, to be legitimate. Examples of these are the Glucosamine/Chondroitin Arthritis Intervention Trial and the NCCAM’s own Division of Intramural Research.

Several grants go to medical schools for the purpose of establishing "integrative medicine” centers, which begs the question of why this should be done in the absence of evidence that “integrative medicine” works.

Cynicism and Fear

Some academic physicians view the NCCAM cynically, as simply another opportunity to get scarce grant money (CAM Director 2001). Straus himself acknowledged this in a recent interview: “people at major universities . . . become stunned thinking that we should be an easy take” (Russo and Maher 2002). Some in academic medicine are undoubtedly afraid that criticism of the NCCAM might displease Sen. Harkin who, as Chairman and/or Ranking Member of the Labor, Health and Human Services, and Education Appropriations Subcommittee, can influence the budget of the entire NIH. This could explain why, according to Straus, “our sister institutes have picked up” several grant proposals that the NCCAM was unable to fund (Russo and Maher 2002).

Straus opined that this must mean that the proposals 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 (Atwood 2003). There are also precedents for Sen. Harkin using his position to wrestle control of medical research away from scientists. In 1994, according to the 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, among them Berkeley Bedell, on the OAM advisory panel (NCAHF 1994). At the 1993 hearing reported by Science, “Bedell . . . complained that the NCI wasn't moving fast enough to validate antineoplaston therapy. Harkin responded that he would `get their attention real fast. I have been around here eighteen years, and I have figured out how to use the purse strings'” (Marshall 1994).

All of this has resulted in the establishment of a cadre of academics who have come to rely on NCCAM funds or who otherwise defend the NCCAM’s existence, with little regard for the scientific issues raised here. Thus many physicians who have not taken the time to consider CAM (and many members of the public) are led to believe that CAM claims are likely to be valid and that the NCCAM project is a noble one.

Human Studies Ethics and CAM

Clinical trials of CAM methods pose particular ethical problems. Drawing from the primary ethics literature of the past fifty years, Ezekiel Emanuel and colleagues have proposed seven universal criteria for determining if a human study is ethical: value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review by unaffiliated individuals, informed consent, and respect for enrolled subjects (Emanuel et al. 2000). All criteria must be met in order to make such research ethical.

Highly implausible or impossible methods, such as homeopathy, craniosacral therapy, “psychic (distant) healing,” Therapeutic Touch, EDTA chelation for atherosclerosis, the chiropractic “subluxation theory” and many other CAM claims are what Emanuel and colleagues refer to as “trifling hypotheses.” Human studies of such methods are, a priori, unethical, quite apart from any political impetus to conduct them. This is both because of the exploitation of subjects for 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 proposals” (Emanuel et al. 2000). In particular, one might add, if those funds are public. Thus the current federal allocation of $110 million per year for the NCCAM might be weighed against the $5 million per year allocated for research on spinal muscular atrophy, a devastating childhood disease that some scientists believe would be on the verge of a therapeutic 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 methods ineffective will benefit society. These are the usual arguments favoring the existence of the NCCAM and CAM research programs in academic medicine, and are often made even by skeptics. But such contentions are irrelevant to the ethical issues and as such are expressly discouraged, as a basis for the Institutional Review Board (IRB) approval of NIH-sponsored study proposals, by the Code of Federal Regulations (CFR 2001): “The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility” (CFR §46.111).

Nor does the virtual certainty that some subjects would use an implausible therapy, even in the absence of a clinical trial, render such a trial ethical: “the IRB should consider only those risks and benefits that may result from the research” (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research) (CFR §46.116).

Plausibility also figures in informed consent language and subject selection. How many subjects who are not wedded to “alternative medicine” would be likely to join a study that independent reviewers rate as unlikely to yield any useful results, or in which the risks are stated to outweigh the potential benefits? Are informed consents for such studies honest? In at least one case cited in the following paragraph, the answer is “no.” Nor may subjects who prefer “alternative” methods be preferentially chosen for such research even if they seek this, because “fair subject selection requires that the scientific goals of the study, not vulnerability, privilege, or other factors unrelated to the purposes of the research, be the primary basis for determining the groups and individuals that will be recruited and enrolled” (Emanuel et al. 2000).

The Office for Human Research Protections recently cited Columbia University for failure to describe serious risks on the consent form of its “Gonzalez” protocol for cancer of the pancreas, funded by the NCCAM (OHRP 2002). The study proposes to compare the arduous “Gonzalez” method, which is devoid of biological rationale, to gemcitabine, an agent acknowledged by the investigators to effect “a slight prolongation of life and a significant improvement in . . . quality of life.” Nevertheless, a letter from Columbia to prospective subjects states, “it is not known at the present time which treatment approach is best [sic] overall” (Chabot 1999). The claim of clinical equipoise, or uncertainty in the expert medical community over which treatment is superior—necessary to render a comparison trial ethical—is not supported by the facts (Freedman 1987).

The proposed Trial to Assess Chelation Therapy in CAD will likely violate several ethical requirements, including lack of scientific validity, lack of value, biased subject selection, and unfavorable risk-benefit ratio. It will be unlikely to recruit subjects—other than those already predisposed to such treatment—unless it presents dishonest consent information (Atwood 2003).

Advisory Councils

There are two councils charged with advising the director of the NCCAM on matters related to research funding and clinical trials: the National Advisory Council for Complementary and Alternative Medicine (NACCAM) and the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM). It might be expected that the membership of these councils reflects the Center’s professed commitment to the rigorous, skeptical inquiry of “complementary and alternative” methods. The director, however, has no formal role in selecting the council members. The members of the NACCAM are appointed by the Secretary for Health and Human Services, with these stipulations: “Of the eighteen appointed members, twelve shall be selected from among the leading representatives . . . of the health and scientific disciplines in the area of complementary and alternative medicine. Nine of the twelve shall include practitioners licensed in one or more of the major systems with which the Center is involved” (NCCAM Charter 2000). The members of the CAPCAM are appointed by the director of the NIH, but with the requirement that "of the fifteen members, eleven shall be nonfederal,” including the Chair, and “nonfederal members will be selected based on their knowledge and expertise in the fields of complementary and alternative therapeutic cancer treatments” (CAPCAM Charter 2002).

Thus it can be predicted that the councils will be biased, prima facie, in favor of the very methods that the Center is charged to submit to skeptical scrutiny. An examination of the rosters of the two councils supports this prediction. Among the NACCAM members in the past three years were Standish and two other naturopaths. In 2000 one of them, Anna MacIntosh, recommended “Gerson Therapy” for cancer and multiple sclerosis (NCNM Web site 2000). This is a regimen of “detoxification” with coffee enemas and a diet including huge quantities of juices made from fruits, vegetables, and raw calf’s liver. The National Cancer Institute had evaluated Gerson’s claims in 1947 and again in 1959, and found them to be baseless (Barrett and Herbert 2001).

The third naturopath on the NACCAM is Konrad Kail, who explains "patient-centered care” this way: “If I see a patient who has pain in his arms because his neck is out of alignment, I explain to them that we can do spinal adjustments, acupuncture, homeopathy, or we can do all three. Then I wait for their [sic] choice” (Morton and Morton 1997).

Another recent member of the NACCAM is Marilyn J. Schlitz, reported by skeptic Dr. Tim Gorski to be “an astral voyager `remote viewer' who was praised by Russell Targ for having `achieved the greatest statistical significance of any remote-viewing experiment so far conducted' in exploring tourist sites in Rome from her home in Detroit, Michigan” (Gorski 2001). Schlitz is a co-investigator with Standish in the aforementioned “transfer of neural energy” study.

On the CAPCAM still sits Ralph Moss, one of the original “Harkinites.” His Cancer Chronicles newsletter has suggested that homeopathy and other implausible treatments can cure cancer (Moss 1995). He has also accused the Mayo clinic of being “fraudulent” (Moss 1993) because of its study that demonstrated the ineffectiveness of laetrile (Moertel et al. 1982). This exposes the fallacy of the social usefulness of studies that disprove sectarian methods.

In considering the rosters of the two councils, one is reminded of physicist Robert Park’s account of a 1995 Senate press conference announcing the release of Alternative Medicine: Expanding Medical Horizons, the report of a workshop sponsored by the Office of Alternative Medicine (OAM workshop 1992). The press conference was hosted by Sen. Harkin. According to Park (2000):

Perhaps the strangest part of the press conference consisted of brief statements by individual members of the editorial review board of what they saw as the most important issues for the Office of Alternative Medicine. One insisted that the number-one health problem in the United States is magnesium deficiency; another was convinced that the expanded use of acupuncture could revolutionize medicine; and so it went around the table, with each touting his or her preferred therapy. But there was no sense of conflict or rivalry. As each spoke, the others would nod in agreement. The purpose of the OAM, I began to realize, was to demonstrate that these disparate therapies all work. It was my first glimpse of what holds alternative medicine together: there is no internal dissent in a community that feels itself besieged from the outside.

Conflicts of Interest

Many NCCAM grant recipients have conflicts of interest regarding the Center. Several grant recipients are or have been members of the NCCAM Advisory Council or the Cancer Advisory Panel. Several members of the "Expert Panel to Assess NCCAM Research Centers,” including the Chairman, are either grant recipients or are affiliated with institutions that receive NCCAM grants (Expert Panel 2002). Several members of the recently formed IOM panel on “Use of Complementary and Alternative Medicine by the American Public,” itself sponsored by the NCCAM, are recipients of NCCAM grants (IOM Web site 2003). No member of that panel has demonstrated expertise in the rigorous evaluation of CAM methods.

Conclusion

Straus has written that the NCCAM “was created to foster and build a research enterprise that subjects complementary and alternative medicine to open-minded, hypothesis-driven investigation” (Straus 2002). That is inaccurate. The NCCAM was created by a few advocates who believed in implausible or disproved health claims, including laetrile, and who felt that the scientific “establishment” was unfairly suppressing them (Gorski 2001; Atwood 2002a; Sampson 2002). As such, the Center’s role has been more one of advocacy than of science. Calls for its abolition have been reasoned and comprehensive (Stalker 1995; Science 1997; Halperin 1998; Sampson 2002).

After more than ten years and $200 million, OAM/NCCAM-sponsored research has not demonstrated efficacy for any CAM method, nor has the Center informed the public that any method is useless (Green 2001). It continues to fund and promote pseudoscience. It continues to be influenced by powerful ideologues.

The problem with so-called Complementary and Alternative Medicine, in a nutshell, is that it is an assortment of implausible, dishonest, expensive, and sometimes dangerous claims that are exuberantly promoted to a scientifically naïve public. The NCCAM, so far, has not been part of the solution.

Acknowledgments

The author is indebted to Wallace Sampson and Elizabeth Woeckner for invaluable discussions and for tips on hard-to-find sources related to the content of this article.

References

Kimball C. Atwood

Kimball C. Atwood IV, M.D. is an anesthesiologist at the Newton-Wellesley Hospital in Newton, Massachusetts. He is Assistant Clinical Professor at the Tufts University School of Medicine and Contributing Editor of the Scientific Review of Alternative Medicine. E-mail: katwood@partners.org.