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United States Senate Special Committee on Aging

Hearing on Swindlers, Hucksters and Snake Oil Salesmen:
The Hype and Hope of Marketing Anti-Aging Products to Seniors
September 10, 2001

A Written Response to the Statement of the Honorable Dan Burton (R-IN),
Chairman, House Committee on Government Reform

By Timothy N. Gorski, M.D., F.A.C.O.G.
Assistant Clinical Professor, University of North Texas Health Science Center
President, Dallas/Fort Worth Council Against Health Fraud
Board Member, National Council Against Health Fraud
Associate Editor, Scientific Review of Alternative Medicine


Introduction

The Honorable Congressman Dan Burton's forceful objections to the Senate Special Committee's hearing and his accusations directed at me and my testimony are serious and deserve a response. I appreciate the opportunity of doing so, though it is without benefit of a paid research staff. In addition, I am under considerable pressure of time while caring for my patients in my full-time practice of obstetrics and gynecology as well as meeting my family obligations. Although I prefer to be brief, the nature of these objections limits that intention.

The Nature and Purpose of the Hearing

To begin with, Chairman Breaux and the Senate Special Committee on Aging are to be commended, not condemned, for considering the very serious problem of fraud in the dietary supplement industry and, in particular, its impact on older Americans. This problem has received very little attention since the 1984 Pepper Report [1], and it is absolutely clear that current law and enforcement resources have been and remain insufficient to address it.

Senator Breaux made it very clear in his opening remarks that the focus of the hearing was on the "bad actors" in the multibillion dollar dietary supplement industry. The activities of Mr. A. Glenn Braswell were considered in detail and it was brought out that current penalties for fraud in this business are insufficient to stop or deter it. Mr. Braswell and Mr. Tepper, appearing under subpoena, repeatedly exercised their Fifth Amendment privileges. Additional witnesses, including myself, presented evidence, including many examples, showing that Mr. Braswell's misbehavior is far from unique and must be considered in its context to be understood.

It was clearly and emphatically not the purpose of the hearing to indiscriminately discount the benefit of all vitamin, mineral or other supplementation of the diet or to condemn all manufacturers of such products. No evidence was presented that would argue for such a conclusion. Nor was the purpose of the hearing to take issue with well-established facts concerning the health benefits of diet, exercise, or the use of vitamin and mineral supplementation generally or in the management of specific health problems. On the contrary, evidence was presented by myself showing that perpetrators of fraud take advantage of the deliberate blurring of distinctions between the rational and the irrational engaged in by advocates of the latter.

It was also not the purpose of the hearing to consider the many ways in which the nation's medical care system as a whole might be improved, or even what improvement might consist of. But the Honorable Congressman Burton took the opportunity to assert that, "Many of our nation's seniors are subjected to treatments in 'conventional medicine' that are not necessary, cost more and are more dangerous than equally effective alternatives."

There are simply no facts to support this claim. As I pointed out in my testimony, there is widespread recognition and a wealth of examples to prove that the standards of medical science -- falsely labeled "conventional," and sometimes "traditional" or "orthodox" -- are in continual flux in response to evidence. Treatments of any kind that are clearly shown to be superior have always quickly supplanted previous methods without need of legislative mandates. This is the essence of scientific progress.

Congressman Burton expresses outrage that I would question the conclusions of a report "published after peer-review in the prestigious New England Journal of Medicine." Yet it is a fact that the findings of the article in question [2] have been systematically misrepresented by its lead author and by other advocates of irrational and aberrant methods including the NCCAM. The facts related to this deception have been documented in another peer-reviewed journal [3]. This is the way of science. The literature is not sacred scripture, but dialogue in which facts are presented, considered, critiqued, and conclusions reached, rejected or modified. But this process should be governed by facts and reason and not by political, ideological or emotional considerations.

DSHEA [Dietary Supplement and Health Education Act]

Several witnesses identified the 1994 DSHEA legislation, however well-intended it may have been at the time, as a principal contributor to the problem of fraud in the dietary supplement industry. This assessment has also been made by others [4-8], including former FDA Commissioner David Kessler [9] and the editors of The New England Journal of Medicine [10].

As the FDA's own website advises consumers, "there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products." [11] The FDA cannot take action against supplements that are worthless or merely suspected of being harmful, as it can -- and has -- in the case of both prescription and over-the-counter medications. Evidence presented at the hearing showed that the FDA has been unable to remove even dangerous supplements from the marketplace, not even ephedrine products which have injured thousands of people. When enforcement actions are taken, the FDA has no authority to inflict financial penalties, so that perpetrators of fraud bear no net financial cost from their predations. There is not even a requirement that the FDA be notified about the sale of a "dietary supplement" or of the identity and whereabouts of its manufacturer and promoters.

In essence, the provisions of DSHEA established an enormous and unprecedented "honor system" for substances promoted as having drug benefits. Evidence presented at the hearing -- which represented merely a small sampling -- showed that many in the industry are simply not honorable. Nor will the promulgation of good manufacturing practices adequately address the problem. So great has the problem become that polling data now show that "a majority of Americans surveyed supported the following: to require that the Food and Drug Administration review the safety of new dietary supplements prior to their sale; to provide increased authority to remove from sale those products shown to be unsafe; and to increase government regulation to ensure that advertising claims about the health benefits of dietary supplements are true." [12]

Evidence was presented at the hearing that the FTC has stepped up its enforcement actions in the regulatory vacuum created by DHSEA. This it has been able to do by relying on its authority to take action against advertising that lacks a competent scientific basis. But Congressman Burton would remove even this means of recourse against fraud in the dietary supplement industry. In the 106th Congress he introduced the so-called "Dietary Supplement Fairness in Labeling and Advertising Act," H.R. 3305, which would have amended the Federal Trade Commission Act in order to render the FTC as ineffectual as the FDA. [13]

I am very grateful that the Honorable Congressman Burton raised the matter of red yeast rice as an alternative to prescription "statin" drugs. This is yet another excellent example of how DSHEA has corrupted the law and, with it, the understanding of Americans with respect to products promoted as having health benefits. For on the one hand was the "drug" lovastatin, sold under the trade name Mevacor®, which the FDA requires be proven safe and effective for its intended purpose before marketing. On the other hand was the "dietary supplement" lovastatin, sold under the trade name Cholestin® (since reformulated), which was not subject to such strictures. Both contained the same active ingredient possessing the same pharmacologic activity and therefore the same potential for beneficial as well as adverse effects. If the "drug" is not safe without its use being prescribed and monitored by a physician, why should the "dietary supplement" be so considered? And if the "dietary supplement" is safe to use without medical supervision, why not the "drug" as well?

The same potential for confusion and contradiction exists whenever a substance is found to exist naturally somewhere in the universe and, at the same time, happens to be a prescription medication. Because of the fact that many medications are derived from animal or botanical sources, this situation can be expected to arise frequently. Another current example is that of vinpocetine, sold in Europe as a prescription drug to treat dementia at the same time it is promoted in the US -- probably fraudulently [14] -- as a dietary supplement to improve memory and concentration. Congressman Burton laments the fact that the FDA eventually won its case in the matter of Cholestin®, but the fact is that if cerivastatin could be found in a plant extract, it could be marketed as a dietary supplement under DSHEA.

UNTHSC Clinical Faculty Appointment

In addressing the Honorable Congressman Burton's personal attack on me, I would like to begin by thanking his staff for discovering an oversight concerning my clinical faculty appointment to the University of North Texas Health Science Center (UNTHSC). Unfortunately, a proper investigation was not conducted with the result that the accusations of intentional misrepresentation or concealed wrongdoing of any kind is absolutely and utterly false, offensive and represents a grotesque smear of both myself and UNTHSC.

The facts are very simple. In late 1987 I joined the medical staff of the Dallas-Fort Worth Medical Center in Grand Prairie, Texas, a teaching hospital utilized by what was then the Texas College of Osteopathic Medicine, later renamed UNTHSC. As a consequence, and much to my satisfaction, I was thereafter continuously involved with the teaching and training of medical students and resident physicians of UNTHSC.

In 1991, without my having taken action of any kind, I was notified that I had been appointed to the assistant clinical faculty of the school's department of Obstetrics and Gynecology. Though unasked for, I was gratified at this simple recognition of the many freely volunteered unpaid hours of effort that I devoted towards educating future physicians. Other members of the medical staff at the hospital were undoubtedly so recognized as well. But as to those details I have no information. In any case, I continued to have direct involvement with the medical education program at the hospital, including the evaluation of medical students and house staff performance until the hospital's closure on November 7, 2000 as a result of federal budget cuts.

At no time did I receive any request from UNTHSC for any credentials verification, a function that was, in any case, carried out routinely by the hospital's medical staff office. Had I received such a request I would have been glad to comply with it. It is outrageous for anyone to assert the contrary: that I could not or would not. It is perhaps even more concerning that it would be assumed that an institution as outstanding and reputable as the UNTHSC would permit uncredentialed or unqualified individuals to teach and supervise its medical students and residents in the difficult, complex, and, at times, hazardous discipline of Obstetrics and Gynecology. I am justly proud of my association with UNTHSC and take spirited exception to its being unjustly slurred.

I am in receipt of a letter dated October 10, 2001, from Ronald R. Blanck, DO, President of UNTHSC, a copy of which I have forwarded to the US Senate Special Committee on Aging. Dr. Blanck stated:

I have learned that we did appoint you as clinical faculty in 1991, and it was never rescinded. Although you were in an inactive status since 1995, your position as Clinical Assistant Professor in the Department of OB/GYN remains valid. You have received a letter from the Acting Chairman of the Department of OB/GYN, Dr. Gary Meyer, requesting additional information so we may update our files and continue your appointment. But, I repeat since you received no notification of termination, and in fact none was sent, your appointment at the health science center remains in force.

I hope this lays to rest any and all doubts in this matter.

Office Of Alternative Medicine (OAM) / National Center for
Complementary and Alternative Medicine (NCCAM)

I did not address the very different and much larger subject of the problems with the OAM/NCCAM in my testimony. My intention was only to put the subject of fraud in the dietary supplement industry into context and to highlight how far government policies of the last decade have departed from the findings of the 1984 Pepper report. But as Congressman Burton characterizes my criticisms of the OAM/NCCAM and the White House Commission on Alternative and Complementary Medicine Policy (WHCCAMP) as unfair or reckless attacks on careful and discerning scientists of world-class abilities and renown, it is necessary for me to cite additional facts to show that this is very far from the truth.

The OAM/NCCAM is widely considered "the brainchild of Iowa Senator Tom Harkin," a creature of politics inspired by his personal experience with the use of bee pollen for hayfever symptoms. It was never established that there was any "unmet research need" to be met. Given the fact that funds available for medical research are limited, the most important consideration is to address the most pressing problems and to do so in a way that maximizes the likelihood of useful results. These principles have not been followed at the OAM/NCCAM. Numerous professional scientists, many of whom have earned legitimate stature for their work, have objected on just these grounds [16].

The NCCAM is the only division of the NIH that is oriented toward a particular class of therapeutic methods, as vague and confused a concept as "CAM" may be. As such, it is the only center that is oriented primarily to the needs, desires and inclinations of practitioners -- whether of acupuncture, homeopathy, "energy medicine" or some other belief system -- instead of the needs, problems and circumstances of patients. Wallace Sampson, MD, Editor of the Scientific Review of Alternative Medicine and Clinical Professor of Medicine at Stanford University who taught a course there on "alternative medicine" for 22 years, has called the NCCAM "a full employment program for pseudoscientists and poor quality physicians." [17] Funding decisions at the NCCAM reflect these assessments, as I will shortly show.

There is no doubt that the NIH did not welcome the imposition on it of the OAM in November of 1991. But the response among advocates of unproven, disproven and irrational medical claims and methods was euphoric. The first acting director of the office was Stephen C. Groft, D.Pharm, whose "friendliness towards the initiative was palpable" according to one enthusiastic advocate [18]. But the peculiar political pedigree of the OAM soon led to problems when this advocate and others on the OAM's Ad Hoc Advisory Committee "were never consulted" about the appointment of its first director, Joseph Jacobs MD. To them he seemed "too conventional in his medical orientation" and, worse, had no proven track record of practicing or promoting aberrant methods [19].

Within a year of his appointment, Dr. Jacobs was called before a special review hearing by Senator Harkin. At this meeting on June 24, 1993, Senator Harkin's friend Berkley Bedell spoke for unhappy advocates, complaining that all the OAM had to do was to conduct "field studies" consisting of compiling anecdotal reports. "When it was Jacobs' turn to testify," according to a report in Science magazine, Senator Harkin "raked him over the coals" and made it clear that the purpose of OAM was to "investigate and validate" irrational and aberrant therapies. Jacobs was quoted as saying that he considered these marching orders "very naïve" as well as "professionally insulting." The article observed that CAM advocates were "eager to have the imprimatur of an NIH review" but "may not want the rigor." Dr. Jacobs responded by saying that "As a taxpayer, I wouldn't trust what comes out of my office under a system like that." [20]

After announcing his resignation but before actually leaving, Dr. Jacobs was faced with an additional demand in January of 1994 to put four "alternative medicine" activists, hand-picked by Senator Harkin, on an OAM advisory panel. According to one account the lawmaker threatened to hold up the entire NIH budget until the individuals were added [21]. These were:

Wayne Jonas MD assumed leadership at the OAM in July of 1995, almost a year after the departure of Dr. Jacobs. Dr. Jonas is a homeopath, a believer in a discredited 18th Century mystical prescientific theory of medicine that asserts the truth of preposterous "laws." One of these, "The Law of Similars," from which homeopathy takes its name, asserts that substances that cause certain symptoms are effective in treating those same symptoms. Another, "The Law of Infinitesimals," states that diluting a substance makes it more potent. Thus, homeopathic "medicine" consists of substances diluted to fantastic proportions, to the point where no molecules of the substance remain.

Dr. Jonas was enamored of homeopathy as a medical student at the Bowman Gray School of Medicine in North Carolina. After suggesting that a patient with severe pneumonia be treated with homeopathy, his supervisors asked him to repeat his rotation in medicine. But even as a medical student Dr. Jonas was impervious to reason. As OAM Director he told an interviewer that "Just as the discovery of infectious agents revolutionized our ability to care for many diseases at the turn of the century, the discovery of what happens when a homeopathic preparation is made and how it impacts the body might revolutionize our understanding of chemistry, biology and medicine." [29]

Dr Jonas co-authored a book on homeopathy in which he makes it clear that he is certain of its effectiveness but is only doubtful about its mechanism. The pattern of nonexistent molecules "must be stored in some way in the diluted water/alcohol mixture" he wrote, suggesting that all manner of occult energies, imaginary "biophotons" or New Age quantum effects could be involved [30]. Of late, Dr. Jonas has become frustrated with homeopathy research, perhaps because of the obvious truth in one medical scientist's observation that such research is nothing more than "a game of chance between two placebos." [31] Dr. Jonas has suggested that validating homeopathy "may require a theory that incorporates subjective variables," [32] which is to say, how the thoughts of patients, doctors, and perhaps their next-door neighbors might influence the effects of a homeopathic remedy. This is in line with mystical beliefs in "nonlocal effects" caused by "intentionality," or, in other words, psychic powers.

This is also entirely consistent with Dr. Jonas' new position on the Scientific Advisory Committee of the paranormalism-oriented Institute for Noetic Sciences (IONS). According to IONS, Dr. Jonas "envisions the development of protocols using gene-array procedures to examine possible genetic expression arising from CAM signals in distant healing." He considers it wrongheaded and obsolete that "the current view of the body is grounded in molecular biology." He prefers to think that "bodily parts [can] communicate over long distances almost instantaneously" by means of "nonlocal characteristics in the biological process, with widely separated parts interacting in ways that don't have obvious physical carriers." [33]

In June of 2001 Dr. Jonas was on the Program Committee of a conference in San Diego touting the reality of UFO's, paranormalism, Qigong, Orgone Energy and other pseudoscientific claims [34]. His preoccupation with aberrant methods appears to be thoroughly ideological if not religious. At one of the hearings of the WHCCAMP, of which he is an appointed member, he stated: " a number of groups are now getting into this field from the orthodox community, because there has been some money available. How can we go about sorting through which ones are truly going to capture the spirit of whole person health or how many are looking really at the bottom line, which is getting redder and redder by the year?" [35]

Dr. Jonas left the OAM at the end of 1998 some two months after its conversion to the NCCAM. By that time many eminent and accomplished scientists had called for its defunding, including former presidential science advisor D. Allan Bromley [36-38]. Especially shameful was the allocation about that time of $1.4 million to the work of Nicholas Gonzalez and his bizarre coffee enema and psychic hair analysis cancer treatments. Even Barrie Cassileth, PhD, Chief of the Integrative Medicine Service at Sloan-Kettering Cancer Center, called Gonzalez' claims and methods "voodoo magic silly Not scientific. Worse than not scientific. This is pure ridiculousness." [39]

When Stephen Strauss MD became director of the NCCAM in October of 1999, many supposed that matters could hardly get any worse. Indeed, Dr. Straus' reputation was such that some dared to hope for improvement. But the new director quickly began defending the funding devoted to the work of Dr. Gonzalez [40].

It is true that under Dr. Strauss the NCCAM has also undertaken large-scale multi-center research trials on Saint John's Wort, Ginkgo and glucosamine, the results of which will likely be trustworthy. Sadly, these are unlikely to be clinically useful for reasons that I pointed out in my testimony at the September 10 hearing. Indeed, after almost ten years and hundreds of millions of taxpayer dollars spent, nothing has yet come out of the OAM/NCCAM that has been shown to be clinically important. Even a definitive study to determine the effectiveness of the bee pollen that Senator Tom Harkin believes cured his hayfever has not been undertaken.

But Dr. Strauss' leadership at the NCCAM is disturbing for other reasons. There is clear evidence either that he lacks scientific judgment or that ideological advocates remain firmly in control at the NCCAM. It may be a contributing factor that, as a virologist, he has no expertise in evaluating aberrant and irrational medical methods. Among dozens of smaller NCCAM research grants, for example, have been many that are wasteful, inappropriate and utterly bizarre. In 2000, for example, three grants were awarded for obvious paranormalism research into "psychic powers," euphemistically called "distant healing" or "transfer of neural energy" from one person to another:

Elisabeth Targ MD, who with the first two of these grant awards scooped up nearly $1.5 million of taxpayer dollars, is head of the Complementary Medicine Research Institute of California Pacifica Medical Center in San Francisco. She is a third generation psychic believer continuing a long tradition of pursuing absurd and discredited paranormal claims. This is a tradition distinguished chiefly by fraud and self-deception [44,45]. Her father, Russell Targ, earned notoriety in the 1970's for bilking the U.S. Department of Defense on promises that "remote viewers" could be trained to provide on-site details of Russian military facilities by visiting them "psychically." According to her father, Elisabeth was trained on a psychic power teaching machine as a young girl and was able to predict the winners of horse races and presidential elections [46]. Distinguished science writer Martin Gardner recently provided additional details about the Targs, their eccentric beliefs and NCCAM funding of them [47].

Janet Quinn, RN PhD, a Therapeutic Touch (TT) practitioner and a former student of TT's founder Dolores Krieger, is a paid consultant to Dr. Targ on the AIDS work and is recruiting additional TT practitioners to act as a "control group" against the main group of psi-powered "healers." $500 honorariums are being paid to perform this "work" with a total of $20,834 allocated for it through the February 28th, 2001 budget period. TT is a mystical "healing" method, the premise of which was falsified by an elementary school science project [48]. The most recent exploits of its founder, Dolores Krieger, are of "doing healing at distance" of those killed in the September 11 attacks on the World Trade Center, "calling upon the help of the angels of compassion to help the person through the terror of dying so suddenly and so horribly. working together with whatever beneficent forces I think of or who present themselves at this time." [49]

Understandably worried about the reaction of more sensible people to her NCCAM-funded studies, Dr. Targ has announced her determination to either get positive results or leave the door open to wasting more of the taxpayers' dollars on her work with psychic powers. At a parapsychology conference entitled "Subtle Energies and Uncharted Realms of the Mind," at the New Age oriented Esalen Institute in July 2000, it was reported that:

Targ discussed the difficulties of doing a clinical research study on distant healing. Since the mainstream medical community is highly skeptical of Targ's research, she must be meticulous at every step in the process. In addition, she must also guard against showing a negative result, because the mainstream will take those results and attempt to discredit what Targ is trying to show. [50]

Current NCCAM advisor Marilyn Schlitz, PhD, and former NCCAM advisor Beverly Rubik, as well as Dr. Targ's father Russell were among the other featured speakers at the event [51].

Dr Strauss is fully aware of and supportive of these grants to Dr. Targ. In his annual director's report given at a February 5, 2001 NCCAM Advisory Committee meeting, Dr. Straus said:

Dr. Targ at the California Pacific Medical Center is studying distance healing for glioblastoma, trying to move this research forward from small trials. The study has 150 patients in a double blind RCT in which healers pray for patient recovery. Endpoints include symptoms and functional status. [52]

The third grant was awarded to one of the NCCAM's own advisory board members, Leanna J. Standish: 1-R21-AT-287-1, Transfer of Neural Energy Between Human Subjects, Bastyr University. Bastyr University is an official NCCAM research center. Its website indicates that Dr. Standish, who is the school's research co-director, is joined in her psychic investigations by fellow NCCAM advisor Marilyn Schlitz PhD. [53].

Dr. Schlitz is also on the board of IONS and directs its research programs [54]. With IONS Fellow Dr. Targ, Dr. Schlitz has been conducting her own psi research at California Pacific Medical Center [55]. In addition, Dr. Schlitz is herself 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 MI [56].

Standish, a "naturopathic doctor," is, in turn, listed as a co-researcher with Dr. Targ on grant #1-R01-AT-485-1. Another NCCAM advisor, Michael F. Cantwell MD, works with Dr. Targ as lead physician in the Health and Healing Clinic at California Pacific Medical Center. Dr. Cantwell was to be the Principal Investigator for a proposed study of Russian psychics healing children with Cerebral Palsy sponsored by the Monterey Institute for the Study of Alternative Healing Arts which the United Cerebral Palsy Research and Educational Foundation declined to fund [57].

These activities, and doubtless others obscured with more pedestrian titles, fly in the face of an exhaustive study of parapsychology by the National Research Council (NRC) conducted in the late 1980's and early 1990's. The NRC concluded that there is "no scientific justification from research conducted over a period of 130 years for the existence of parapsychological phenomena." [58] Although clearly supported by Dr. Strauss, it is only fair to say that the NCCAM's interest in parapsychological research had begun earlier. These forays into mysticism disguised as science were suggested in a report issued by the OAM's Mind-Body Panel when it was cochaired by paranormalist Larry Dossey MD, Jungian "transpersonal psychologist" Jeanne Achterberg and James S. Gordon MD who is now Chair of the White House Commission on Complementary and Alternative Medicine Policy. This report falsely asserted that:

There exist many published reports of experiments in which persons were able to influence a variety of cellular and other biological systems through mental means. The target systems for these investigations have included bacteria, yeast, fungi, mobile algae, plants, protozoa, larvae, insects, chicks, mice, rats, gerbils, cats, and dogs, as well as cellular preparations (blood cells, neurons, cancer cells) and enzyme activities. In human "target persons," eye movements, muscular movements, electrodermal activity, plethysmographic activity, respiration, and brain rhythms have been affected through direct mental influence. [59]

All of this alleged evidence was considered and rejected by the NRC's review. Yet it is continually pointed to by dishonest promoters of paranormalism.

But it may very well be that Dr. Strauss, in his heart of hearts, would agree that these and many other NCCAM-funded activities are absurd and unscientific. It may very well be that, as one journalist wrote last year:

[P]rinciples aside, Straus also has to follow the mandate of Congress - and some of its, well, less-than-scientific members. NCCAM is stuck funding a 5-year, $1.4 million trial of an unusual protocol designed to treat terminal pancreatic cancer by physician Nicolas Gonzalez. The so-called Gonzalez Protocol -- a hodgepodge of pancreatic enzymes, coffee enemas, and up to 150 dietary supplements a day -- caught the attention of Representative Dan Burton (R-IN), who in 1998 encouraged the National Cancer Institute (NCI) to study it. Even though Straus considers the evidence just an "aggregate of interesting anecdotes," he defends the trial -- albeit lukewarmly. "I'm more comfortable and find it easier to approach and fund things that already make a lot more sense to me," he admits. "But the mandate here is ... to be willing to take more risks for things that are novel." [60]

Yet the sad fact remains that these "things that are novel," especially when they are given the imprimatur of the NIH, ultimately put the public at risk for the kinds of harm that I outlined in my testimony on September 10. Perhaps the most egregious example is that of Dr. Gonzalez, who had already been found guilty of medical malpractice and ordered to pay more than $2 million in 1997. Another case was then underway involving a death in which Dr. Gonzalez was ultimately found guilty again -- in April of 2000 -- and ordered to pay $282,000 to the husband of a woman who died under his care [61]. Yet at the urging of Congressman Burton, the NCCAM ignored these considerations and made the preposterous decision that there was good reason to suppose that Gonzalez's methods had merit. Indeed, it is exceedingly puzzling that Congressman Burton trusts American citizens to make their own medical choices when he cannot trust the professional judgments of NIH and NCI research scientists.

White House Commission on Alternative and
Complementary Medicine Policy (WHCCAMP)

The situation with respect to the WHCCAMP is even worse. Established by President Clinton on March 7th of 2000 by Executive Order 13147 and subsequently amended, the group is charged with providing a report "on legislative and administrative recommendations for assuring that public policy maximizes the benefits to Americans of complementary and alternative medicine." The commission's report is due in March of 2002, but there is little doubt that it will recommend expanded federal spending and other policy initiatives to foster irrational and aberrant methods.

The WHCCAMP Chair is James S. Gordon, MD, a Georgetown University psychiatrist who has said that he found "a whole other system of medicine operating under completely different laws" in the1960's when he began studying traditional Chinese medicine. Then, while receiving his training in psychiatry, Dr. Gordon said, he decided that schizophrenia and other disorders "did not seem like diseases to me [but] instead like different ways of being." It was at this time that he became a student of the radical British psychiatrist R. D. Laing whose "Insanity is Sanity" philosophy achieved great popularity in the 1960s drug counterculture [62]. Dr. Gordon appears to have become enamored of these ideas at the very time that Kingsley Hall, Laing's London "therapeutic community" in which the mentally ill and their therapists lived together and -- among other things -- indulged in LSD, was forced to close under a cloud of scandal and public complaint [63]. His thinking distorted by long-term LSD use [64], Laing himself went on to become involved in "Primal Scream" and "rebirthing psychodrama" [65] of the kind that killed a young girl in Colorado in May of 2000 and sent two therapists to jail [66].

Dr. Gordon was a follower of the late Bhagwan Shree Rajneesh, the Indian mystic who amassed wealth and influence enough to take over the small town of Antelope, Oregon in the 1980's before being deported by the authorities for fraud. Dr. Gordon wrote a sympathetic book about the cult, The Golden Guru, in which he offered excuses for the Bhagwan's erratic behavior and the violence connected with the cult. Dr. Gordon also describes his own "rebirthing" experience at the hands of one of the Bhagwan's therapists [67]. In 1984, some followers of the Bhagwan cult were involved in deliberate poisonings of hundreds of people in Oregon [68].

In recent years, Dr. Gordon has been a collaborator of parapsychologists and Jungian mystics within the Transpersonal Psychology movement [69]. He has also become a leading advocate of alien abduction therapy and research, serving on the Scientific Advisory Board of the Program for Extraordinary Experience Research (PEER), an organization established explicitly by Harvard psychiatrist John Mack, MD, to research alien abductions [70].

Inexplicably, Dr. Gordon also involved himself in the Oklahoma bombing trial of Terry Nichols. As a psychiatrist for the defense, he submitted a letter to the court stating that Nichols was not violent and should not receive a long prison term. Dr. Gordon's opinion was apparently based entirely on letters received from Nichols [71].

Dr. Gordon is a fellow of the John E. Fetzer Institute, which funded the dishonest 1993 report published in The New England Journal of Medicine by David Eisenberg and others that claimed that a third of Americans were using "alternative" methods by including such categories as relaxation, imagery, massage, commercial weight loss and self-help groups. One of Gordon's many books, Manifesto For A New Medicine, is in the millenarian genre of others that predict the transformation of medical care along New Age lines.

In 1994, Dr. Gordon was appointed the very first chairman of the Office of Alternative Medicine's Program Advisory Council and was a co-director of OAM's Mind-Body Panel. Through his Center for Mind-Body Medicine, which has also been funded by the Fetzer Institute, Dr. Gordon has organized a series of Comprehensive Cancer Care Conferences that have gathered together dozens of questionable practitioners as an effective lobbying force for aberrant cancer care [72].

Dr. Gordon has previous experience as a Presidential advisor, having directed a nationwide study of alternative mental health services for President Carter's Commission on Mental Health in the 1970s. In his brief 1978 report, in addition to noncontroversial mental health programs such as rape support and runaway programs, Gordon recommends the spiritual midwifery practices of "The Farm," a psychedelic commune, reiterates his support for R. D. Laing's and Carl Jung's theory of psychosis as creativity (R. D. Laing is directly quoted referring to schizophrenia as "a voyage into self of a potentially revolutionary nature") and offers praise for the then budding holistic medicine industry [73].

Other members of the White House Commission include Dr. Jonas, whose exploits have already been considered and:

The appointment of the last three members of the commission appears to be a cynical attempt to enlist the support of racial minorities in the cause of legitimizing irrational and aberrant medical claims and practices. This should be seen in the context of the ideological beliefs of other commission members, including its Chair, in the notion that science is little more than a tool of cultural domination and oppression. It is a shameful attempt to dissuade groups that are in the greatest need of accessible and equitable medical treatment to be satisfied, instead, with something less than the standards of science and reason. That this recurrent theme in the "alternative medicine" movement could appeal to a cynical interest in cost-saving at the expense of the lives and health of the nation's elderly is particularly worrisome [130]..Former Colorado Governor Richard Lamm's assertion that Americans have "a duty to die and get out of the way with all of our machines and artificial hearts and everything else like that" is not one with which all Americans disagree [131].

Completely absent from the WHCCAMP are any individuals whose concern is primarily for sound science, evidence-based medicine, and the protection of the public from health fraud. It is all the more surprising given the ready availability of many individuals who have established reputations as scholars of the subject of unproven, disproven and irrational methods often subsumed under the heading of "alternative" and "complementary" medicine.

That the commission was created for the purpose of advocacy is also shown by the fact that its Executive Director and Secretary are also ideological proponents of "alternative medicine." The former is Stephen C. Groft, who began as the acting director of OAM at its inception. The commission's Executive Secretary, Michele Chang, is a massage therapist who has worked for Senator Tom Harkin and says that she "help[ed] with the conception of this Commission." At the WHCCAMP's first meeting she expressed her belief that there is a "need to consider hearing from people who are practicing CAM modalities in secret" but who "are afraid that they are going to be closed down once the authorities become involved." [132]

Conclusion

The objections of the Honorable Congressman Burton to the nature and substance of the September 10 hearing of the Senate Special Committee on Aging are misplaced, misinformed, and unfair. All of those who spoke at the hearing, with the exception of Mr. Braswell and Mr. Tepper, were plainly interested in drawing the distinction between health-related claims that are based in facts and reason and those that clearly are not. This is the very same standard that was applied in the 1984 Pepper Report and from which current government policies have strayed dangerously. Not only are there serious problems with DSHEA but these problems exist in a context of political institutions such as the NCCAM and the WHCCAMP that are at best tolerant of quackery and at worst tend to directly or indirectly promote it. The controversy over these and related issues is not fundamentally one between personalities or philosophies but between reason and unreason in the sphere of the marketplace for health-related products and services.

I wish to acknowledge and thank consumer activist E. Patrick Curry, for his collaboration on previous presentation of some of the material included in this response [133].

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  17. Sampson, WI, personal communication.
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  21. "NIH OAM Director Resigns; Herbert Calls For Investigation Of Appointees," NCAHF News 1994 Sept/Oct available online at http://www.ncahf.org/nl/1994/9-10.html
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  24. Ralph W. Moss, Ph.D., Brooklyn, N.Y. posted at http://www.ralphmoss.com/nytimes1.html; 10/1/2001
  25. "Notes From Ann's Diary -- A Talk Given in 1996" at http://store.yahoo.com/annieappleseedproject/andiarofhers.html
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  35. At a hearing on Monday, December 4, 2000 (Afternoon Session) Hubert H. Humphrey Building, Room 800 200 Independence Avenue, SW Washington, D.C., posted at http://www.whccamp.hhs.gov/meetings/transcript_12_4_00_afternoon.html
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  39. ABC News 20/20 program "Controversial Cancer Treatment," June 16, 2000 available online at http://more.abcnews.go.com/onair/2020/2020_000616_cancer_feature.html
  40. http://nccam.nih.gov/ne/occam-testimony.html
  41. This is the correct spelling of Dr. Targ's first name. It is misspelled "Elizabeth" on the NCCAM website at http://nccam.nih.gov/research/grants/rfb/combined_fy00.htm
  42. Grant Cost Spreadsheets obtained from NCCAM by an FOIA request in late 2000.
  43. Ibid.
  44. Cromer, Alan, "Pathological Science: An Update," chapter in Kendrick Frazier, Encounters With the Paranormal, Prometheus Press, Amherst, NY, 1998
  45. Gilovich, Thomas, "Belief In ESP," chapter 10 in How We Know What Isn't So, Free Press, New York 1991.
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  47. Gardner, Martin, "Distant Healing and Elisabeth Targ", Skeptical Inquirer, March/April 2001; 12-14. Available online at http://www.csicop.org/si/2001-03/fringe-watcher.html
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  52. NCCAM Meeting Minutes, February 6, 2001 available online at http://nccam.nih.gov/an/advisory/naccam/minutes_new/minutes_0201.html
  53. http://www.bastyr.edu/research/projects
  54. http://www.ions.org/ions/about/board.asp
  55. http://www.cpmc.org/services/ihh/about/cmriprojects.html
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  57. http://www.whps.com/misaha/cantwell.html
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  59. Available online at http://www.naturalhealthvillage.com/reports/rpt2oam/mindbody.htm
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  61. Maull, Samuel "Coffee Enema Doctor Sentenced," Associated Press, April 20, 2000.
  62. Interview with Barry Chowka published in Nutrition Science News, September. 1996 http://www.naturalhealthvillage.com/newsletter/15july00/interview.htm
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  65. Ibid, pp. 125-131
  66. Articles on this rebirthing death are located at http://denver.rockymountainnews.com/candace/
  67. Gordon, James S., The Golden Guru, Lexington, Mass; The Stephen Greene Press; 1987. Notable passages from The Golden Guru: (a) Dr. Gordon describes his own "rebirthing" in Chapter 3 "Surrender to Bhagwan." pp 86-89. At the hands of a naked female therapist, Dr. Gordon recounted "a replay of my descent through the birth canal" leaving him "flailing on the mat, squalling like a newborn," feeling "gratitude and love, not so general now as in groups, but focused on Rajneesh, on his generosity." (b) On pages 84-86, Dr. Gordon defends the use of violent psychotherapies short of killing, which did happen at the Rajneesh's commune in India. He writes that he is "not against fighting in groups" and that the Rajneesh's followers "believed that the violent confrontations -- even their own bad bruises and broken limbs -- had been a small and necessary price to pay for the freedom they now felt from past traumas and inhibitions, for the perspective they had gained on their own sadism and masochism." (c) On page 114, Dr. Gordon defends the Rajneesh' s collection of 93 Rolls Royces at the Oregon commune. "In displaying his wealth so conspicuously, in ignoring accusations of selfishness," writes Dr. Gordon, "Rajneesh was mocking the preconceptions of his New World audience, who -- particularly the Christians -- tended to associate spirituality with poverty, modesty, charity." (d) On page 148, Dr. Gordon defends the Rajneesh's recruitment and exploitation of the homeless and mentally ill, saying that the guru's "program, in spite of its inequities and exploitativeness, does seem a great improvement over what these men have been offered in city and state mental hospitals and shelters. Those who stay are functioning, useful members of a loving community. They seem to have a real opportunity to change." (e) In his concluding paragraphs on page 245, Dr. Gordon writes exults in Rajneesh's "vision of a loving, cooperative community dedicated to the creation of new men and women living in harmony with their own nature and the natural world. For me, it is not finally a question of agreeing or disagreeing with Rajneesh, of praising or condemning him or his sannyasins. It is, rather, a matter of learning from him and them, of appreciating his remarkable talents and gifts and recognizing his perverse uses of them, of seeing myself in him and his sannyasins, of using his extraordinary story and strange, as yet unfinished journey as a mirror for my own."
  68. Torok TJ, Tauxe RV, Wise RP, Livengood JR, Sokolow R, Mauvais S, Birkness KA, Skeels MR, Horan JM, Foster LR., "A large community outbreak of salmonellosis caused by intentional contamination of restaurant salad bars." JAMA 1997 Aug 6;278(5):389-95.
  69. He is listed as a plenary speaker at a 1999 "Life After Death" conference of parapsychologists and mystics at http://www.pathwaysminneapolis.org/lifedeath.html. He has also appeared at conferences of followers of the noted "orgone energy" pseudo-psychologist Wilhelm Reich http://members.aol.com/mannionabc/ and has advocated that resources be devoted to researching "orgone accumulators."
  70. Dr. John Mack's PEER website can be viewed at http://www.peer-mack.org/learnmore.html
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  72. The Quackwatch website lists Gordon's book on these conferences, Comprehensive Cancer Care (James S. Gordon, MD, and Sharon Curtin, 2000) on its list of non-recommended Cancer information books at http://www.quackwatch.com/00AboutQuackwatch/altseek.html
  73. Alternative Services: A Special Study (Final Report to The President's Commission on Mental Health of the Special Study on Alternative Mental Health Services, James S. Gordon, Director)), in Task Panel Reports Submitted to the President's Commission on Mental Health, President's Commission on Mental Health, Volume II, Appendix. 1978.
  74. http://atc.utmb.edu/altmed/books.htm
  75. http://atc.utmb.edu/altmed/
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  80. http://www.eastwestqi.com/html/dr__chow.html
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  88. http://www.worldchiropracticalliance.org
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  106. http://www.ayurvedaonline.com/advisors.html
  107. http://www.rationalradio.com/e006.html
  108. http://www.med.cornell.edu/gradschool/fac/fins.html
  109. http://www.whccamp.hhs.gov/meetings/transcript_01_23_01_part2.html
  110. http://www.americanspecialtyhp.com/
  111. http://www.acupuncturetoday.com/archives/2000/oct/10clinton.html
  112. http://www.tai.edu/index.html
  113. http://www.tai.edu/press_releases.html#whouse
  114. http://www.whccamp.hhs.gov/meetings/transcript_070201v2p1.html
  115. http://www.fihm.com/
  116. http://www.quackwatch.com/12Web/rosenthal.html
  117. Kolata, Gina "At Dinner With Dean Ornish -- A Promoter of Programs To Foster Heart Health," The New York Times December 29,1998 available online at http://members.aol.com/annullas/newstory/nytimes.htm
  118. Ibid.
  119. http://www.insight-books.com/new/0062502522.html
  120. http://www.twbookmark.com/books/20/0446673358/
  121. http://www.cmbm.org/
  122. http://www.whccamp.hhs.gov/meetings/transcript_000713_content.html
  123. http://newsun.com/fair.html
  124. http://www.cmbm.org/conferences/ccc98/transcripts/fair.html
  125. http://www.tomsofmaine.com/
  126. http://www.saltwater.org
  127. http://208.5.178.253/products/wellnsextract.htm
  128. http://www.nihb.org/home/profiles.htm#Traditional Medicine
  129. http://www.rehabpub.com/departments/42001/2.asp
  130. "Would 'Alternative Medicine' Save Health Care $$$?" NCAHF Newsletter 1993 May/June 16(3):1 available online at http://www.ncahf.org/nl/1993/5-6.html
  131. http://www-hsc.usc.edu/~mbernste/ethics.dutytodie.html
  132. http://www.whccamp.hhs.gov/meetings/transcript_000713_content.html
  133. Gorski T, Curry EP, "White House Commission Stacked against Science," Scientific Review of Alternative Medicine 2001;5(1):7-8.

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