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NCRHI News, September/October 1998

Volume 21, Issue #5

THE TEACHING OF ALTERNATIVE MEDICINE
IN U.S. MEDICAL SCHOOLS

A survey of US medical schools conducted in January, 1997, found that 75 schools reported offering elective courses in complementary or alternative medicine or including these topics in required courses. Of 123 courses among these schools, 68% were stand-alone electives, 31% were part of required courses, and 1% was part of an elective. Departments of family medicine or internal medicine were the most common homes for such courses (31% & 11% respectively). Not all give academic credit for such course work. The key finding was the diversity found among the courses for content, format, and requirements. This again demonstrates the chaos the alternative medicine issue has created within standard medicine. The authors note that the nature of the courses were frequently determined by the interests and familiarity of the course directors and availability of local practitioners willing to participate with lectures or demonstrations.

The authors say that students have had "an enormous influence" on the development of such courses but provide no data on this. Recommendations call for more uniformity in course offerings and that such courses: (1) focus on critical thinking and a critical reading of the literature; (2) identify content and express clear learning objectives; (3) include an experiential component; (4) promote a willingness to communicate professionally with alternative practitioners; (5) teach students to talk to patients about alternative therapies.
[Wetzel MS, Eisenberg DM, Kaptchuk TJ, "Courses involving complementary and alternative medicine in US medical schools," JAMA , 1998;280:784-7]

Comment. The report was typical of what we have come to expect from Eisenberg and associates, part survey and part propaganda. The propaganda began with a misstatement of Eisenberg's 1993 study, to wit: "We have known for several years that approximately 1 in 3 adults uses chiropractic, acupuncture, homeopathy, or one of many other treatment modalities." According to the cited data 7% used chiropractic services, and less than 1% used acupuncture or homeopathic services. It gets worse! Authors say: "Reasons cited for the trend toward the use of alternative therapies includes dissatisfaction with conventional health care that is ineffectual, too expensive, or too focused on curing disease rather than maintaining good health." Their list is supported by citing an opinionated editorial addressing frustrations of overworked medical students, end of life care issues, and some others that had nothing whatever to do with why people are using alternative medicine. The authors don't even seem to be up-todate on the topic for which they are best known! The reasons for modest increases in the use of alternative medicine was addressed by the Landmark Report described in the MarApr, NCAHF Newsletter . The increases were most likely due to the enormous amount of positive publicity alternative medicine has received, coupled with aggressive marketing. We have not seen evidence that people are turning to alternative medicine because of dissatisfaction with standard medicine for being "ineffectual, too expensive (Ed. it is, of course), or too focused upon curing disease rather than maintaining good health."

Such generalizations smack of demagoguery (ie, "popular prejudices and false claims to gain power" [influence]). There have been few instances in modern times where the "self-fulfilling prophecy" concept has more clearly manifested itself than in the false statement seen in Eisenberg's 1993 conclusion that "the frequency of use of unconventional therapy in the United States is far higher than previously reported." It wasn't, and a simple review of the studies they cited will prove it. This report adds fuel to the illusion that standard medicine is impressed with the value of alternatives. The most saving feature is the authors' recommendation that courses focus on critical thinking and evidence-based strategies to distinguish useful from useless interventions.

QUALITY CONTROL STILL A PROBLEM WITH HERBALS

The Los Angeles Times commissioned an analysis of ten brands of St. John's wort. Three were found to have no more thanhalf the potency listed on the label, and another four had less than 90% of the labeled amount. One of the lowest scoring products, with about 20% of the labeled potency, was from Sundown Herbals, a division of Rexall, the nation's #1 distributor of dietary supplements. The other two lowest scorers were from Pure Source and Futurebiotics. [Associated Press , 8/31/98]

DO CHIROPRACTORS HAVE TO TELL THE TRUTH
IN PATIENT EDUCATION BROCHURES?

In January, 1995, the Federal Trade Commission ordered Tedd Koren, DC, president of Koren Publications, Inc, to substantiate numerous claims made in Koren's chiropractic brochures. Included were the claims that chiro care: is more effective than Ritalin; can increase IQ; confers increased resistance to common childhood diseases (measles, mumps, chicken pox); is more effective for symptoms common in neurological dysfunctions syndrome; provides relief for gynecological problems, and more. Koren's attorneys negotiated a less aggressive set of claims which were also rejected by the FTC in 1997. Koren is crying "foul" because the FTC requires scientific evidence to back up medical claims. Koren believes that "scientific evidence" is tantamount to "allopathic medical evidence." He whines that "the FTC could do what the AMA could not" (could they possibly mean exposing chiropractic as a fake?). Koren is trying to raise $500,000 immediately from other chiros to pay his attorneys $400 an hour to fight for his right to make claims of health benefit without having to meet established standards of veracity. Koren doesn't grasp the fact that the scientific method is not the property of the medical establishment. Chiropractors are free to be as scientific as they wish. John Triano, DC, takes Koren to task for his folly. Triano notes that Koren's claims do not even have supportive evidence in the chiropractic literature. All that Koren has is his ideology. No matter. Koren is going to attack the FTC. Well, why not. Attacking law enforcement worked for OJ. Koren is right about one thing. If the FTC starts looking into alternative medical claims, many cases of false advertising and labeling will emerge and it will be hell to pay. An FBI agent once told William Jarvis that quackery is easily prosecutedas wire or mail fraud. It's just that most of the time the law has more serious problems to deal with. Koren's situation is discussed in the Sept 21 Dynamic Chiropractic.

MAINSTREAM DRUG COMPANIES MARKETING HERBAL REMEDIES

It has been a dirty little secret that some herbal remedy producers were owned by mainstream drug companies, but now well-known manufacturers are coming out with herbal remedies under their own names. According to the September issue of the Pharmacist's Letter we'll soon see Centrum Herbals and One-ADay herbals. Centrum will have a new line of single herbals such as saw palmetto, St. John's wort, echinacea, etc., and One-A-Day will have seven vitamin and herbal combinations. One-ADay Cold Season contains echinacea, vitamin C, and zinc; the Cholesterol formula contains garlic, soy, and vitamin E; Tension and Mood contains St. John's wort, kava, and B vitamins. A new multivitamin product called Radiance is a multivitamin with added ginseng, garlic, chromium picolinate, CoEnzyme Q10, pycnogenol, red wine and green tea extracts. The Pharmacist's Letter says that these products should not merely be passed off as mere herbal promotions. It cautions readers that the ingredients found in such products might interfere with other medications or adversely affect people's medical conditions. People also need to know that herbal combinations may have unpredictable consequences since little is known about interactions.

BURZYNSKI PROBE FINDS UNFLATTERING PICTURE

An in-depth investigation by U.S. News & World Report (Oct 5, 1998:28-35) took the glow off of the positive report issued by the Burzynski Research Institute (BRI) in May (see May-June, NCAHF Newsletter , p.2). According to the report, the Cancer Letter , a newsletter for doctors, researchers, and patients, found the BRI report badly wanting. "Among their conclusions: Burzynski's protocols, or trials, are poorly designed, making data impossible to interpret. 'They have all the trappings of protocols,' Howard Ozer, director of the Allegheny Cancer Center in Philadelphia, told U.S. News , 'but they cannot be analyzed statistically.' They also noted that many patients withdrew from the study, even though Burzynski reported that they were responding to treatment. 'People usually keep taking medicine that's working,' says Peter Eisenberg, a Marin County oncologist, 'unless the side effects outweigh the benefit'." Burzynski has always claimed that there were no adverse side-effects, but the U.S. News report says otherwise."

According to the FDA's analysis of the data, the therapy contributed to the deaths of at least seven people through its most common side effect, hypernatremia—a potentially lifethreatening condition associated with high levels of sodium in the therapy. The FDA reported that 65% of Burzynski's patients had hypernatremia." The case reports in U.S. News reveal a pattern of behavior on the part of Burzynski that seemed apparent in the CBS 48 Hours on-site probe aired on or about March 5, 1997. Burzynski told patients that their tumors were "breaking up" or "dissolving." Adverse symptoms (disorientation, high fevers, constant thirst) were interpreted as positive evidence that the tumor was breaking up. One young woman, Andrea Walsh, RN, was told this on Sept 29, 1997, but died within hours. The families of some former patients are suing BRI, but it is using the defense they signed informed consent forms before entering into treatment. Such a defense conjures up the specter of what would happen if provisions of the so-called Access to Medical Treatment Act become law. It is not difficult to get hopeful cancer patients to sign consent forms. Such is not a free-will act, but one of desperation.

Comment. Burzynski resides in a fortress made up of a cadre of surviving patients, and the consent forms signed by others in order to avoid conducting the tests necessary to determine the value of his therapy. The National Cancer Institute offered BRI free testing but was unable to obtain his cooperation. His fortress will remain formidable unless patient advocate groups demand that Burzynski be required to play by the same rules adhered to by legitimate cancer treatment programs. It is revealing that his chief advocates in Congress argue for some kind of a two-track system rather than a level playing field for everyone.However, to assuage the patients who are convinced they are being helped, the government should operate some kind of a tightly controlled humanitarian program to provide patients with what they believe to be life-saving medicines.

FDA GUIDELINES ON DIETARY SUPPLEMENTS

The Sept-Oct FDA Consumer contains "An FDA Guide to Dietary Supplements" which provides some background information on the 1994 Dietary Supplements Health & Education Act and FDA's current rules of regulation. The article contains some useful information on the hazards of some dietary supplements, but for those familiar with the dietary supplement marketplace, the article is far too complacent. The FDA undoubtedly fears the ability of the industry to influence congress to further gut the Food, Drug & Cosmetic Act. Such fear is justified given the willingness of the health food and supplement industries to mount Big Lie campaigns and to influence congress with political contributions. We sympathize, but still criticize FDA for not pointing out the failings of the new system. The FDA's breakdown in principle was obvious when the article finished by stating that "consumers need to be discriminating. FDA and industry have important roles to play, but consumers must take responsibility too."

It is not clear how consumers can be reasonably expected to know when real dangers exist. How are consumers to know when ingredients are adulterated, contaminated or counterfeited? How are consumers to know how to properly apply dietary supplements such as potent herbal remedies when inadequate information is provided on labels? Why does the FDA tell consumers to check with their physicians when it knows, or ought to know, that no information exists regarding food and drug interactions or on the effects of long term use (even poison control centers cannot supply needed information). How can consumers possibly know when poor, rather than good, manufacturing practices have been applied? The article suggested writing to manufacturers on this. Right! The letter might read: "Dear Mr. Fox, Is it now safe to go into the henhouse? Signed, Mr. Chicken." Given the poor self-policing record of the dietary supplement industry, we areamazed at such naivety. It is fundamental to consumer protection that regulation is needed under circumstances in which buyers are unable to protect themselves. The FDA statement reflects the recommendations of the Commission on Dietary Supplements which sided with industry's "blame the victim" position of having consumers bear responsibility for harm caused by supplement misuse.

NEJM STRONGLY CRITICAL OF
UNREGULATED ALTERNATIVE REMEDIES

The fallout from the ill-conceived 1994 Dietary Supplements Health & Education Act (DSHEA) has finally hit the fan at the New England Journal of Medicine . An editorial, "Alternative medicine--the risks of untested and unregulated remedies" (Sept 17, 1998) is a splendid statement on the dismal state of affairs that DSHEA created, and pleads "for the scientific community to stop giving alternative medicine a free ride." The editorial rightly states that "There cannot be two kinds of medicineconventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a medicine has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments."

Comment. The NEJM is no longer "politically correct," but it is definitely correct in making the issues crystal clear.

CONTAMINANT RESPONSIBLE FOR EMS
DETECTED IN HEALTH FOOD SUPPLEMENT

Mayo Clinic researchers said that they had found a possibly harmful chemical contaminating tryptophan, a supplement sold in health food stores to promote sleep and as a diet aid. The contaminant, known as peak-X has been linked to the potentially deadly eosinophilia myalgia syndrome (EMS). [Natural HealthLineR for 9/1/98]

DR. WEIL'S POPULARITY FINALLY EXPLAINED

Andrew Weil, MD, has become the poster boy for nonstandard medicine. Even Time magazine saw fit to put him on its cover. We could never quite figure out why Weil was so prominent. His books are trite [1], his idea of spontaneous healing sophomoric [2] and his notion of "integrative medicine" nothing but a renaming of eclecticism [3] Finally, Dr. Anthony Daniels provides the most believable explanation that we have seen in "Books, arts & manners to heal the hollow soul," National Review , 7/6/98. Daniels writes: "Dr. Weil's finest argument is not evidence, it is his appearance: could any MD with so Tolstoyan a beard and so simple a mode of dress fail to have achieved enlightenment? In the Gucci-Armani culture, dressing with studied carelessness and indifference is a sign of profundity." Those Canon commercials were right—"Image is everything!"

Notes: [1] See Dr. John Renner's critique of Weil's 8 Weeks To Optimum Health entitled: "What happened to evidence on the road to wellness?" Sci Rev Alt Med 1997;1(1):36-7. [2] The idea of body self-healing is as old as Hippocrates (400 BCE). [3] Weil proposes to "integrate the best of alternative, complementary, and regular medicine in a single system." Such is merely a new name for eclectic ie, "A sect or school which professes to select what is best from all systems of medicine." (Dorland's Illustrated Medical Dictionary) . This idea wins approval as a laudable goal, but offers no new solution on how to judge which medical practices are "best." Determining the value of a medical procedure still has to be done scientifically. Physicians are willing to accept any practice that can be proven to be of clinical value. They are open-minded to new methods, but not empty-minded. They are mindful of how clinicians have been fooled in the past by promising medical procedures that turned out to be useless--or even harmful--when subjected to randomized, double-blind clinical trials. Responsible practitioners demand hard evidence of safety and efficacy before they are willing to use a procedure on their patients.

STRONG EMOTION DISPLAYED AT HEARINGS
ON ACCESS TO ALTERNATIVES

Alternativists have been clamoring for Congress to pass a federal "medical freedom" law that would legitimize "alternative" health care. The so-called "Access to Medical Treatment Act" has been reintroduced in every session of congress since 1994. The bill is unlikely to pass this session, but it will surely be back again and again. The title is misleading because it suggests that people unable to obtain healthcare would be helped by it. In reality, the law would protect renegade practitioners from sanctions by licensing boards when they fail to meet established standards of conduct.

A more fitting title would be "the Medical Maverick Protection Act." On Feb 4&12, 1998, the House Committee on Government Reform and Oversight, chaired by Dan Burton (R-Ind), held hearings on the 1998 House version, HR746 (the Senate version is S578). Its report, Patient Access to Alternative Treatments: Beyond the FDA , (Serial No.105-103) is available from the U.S. Government Printing Office, or from one's Congressional Representative. The gist of the law is that any person would have the right to be treated by whatever treatment he or she desires, so long as: (1) The treatment is provided by a properly licensed practitioner, under the limits of the practitioner's license, who has examined the patient. (2) There is no evidence that the treatment would be a danger to the patient. (3) The patient has been informed of the contents of the treatment, and any possible side effects, including a written statement that says, "This treatment has not been certified safe and effective by the Federal Government, anyone who uses it does so at their own risk." (4) There have been no advertising claims made regarding the efficacy of the treatment. (5) The patient has signed a statement that they have been informed of all of the above.

The bill is wrongheaded because having a license to practice a form of health care in the United States is no guarantee that the practitioner is competent or trustworthy. Every state licenses nonscientific chiropractors; a dozen states license naturopaths; three license homeopaths; and a dozen have medical freedom laws that exempt renegade doctors from accountability in a way similar to that proposed by HR746. The bill invites patients to be guinea pigs for practitioners with a history of making no serious effort to track for harm. Responsible medicine observes the ancient dictum, "primarily, do no harm," which does not presume safety when there is no information.

It is not clear whether "advertising" is limited to clear promotions by the caregiver, or if it includes "hidden advertising" (eg, health misinformation in health food magazines, health books, infomercials, cassette tapes, videos, oral sales pitches by health hucksters, etc.) done under the guise of patient education. Numbers 3 and 5 provide medical renegades with an "I told you so!" defense. The same defense that has enabled the tobacco industry to escape accountability for killing millions of Americans.

The hearing generated more heat than light.

Eighteen people testified. Ten were cancer patients. Five of these were patients of Stanislaw Burzynski spitting venom at the FDA for prosecuting him. None actually spoke directly about HR746, but mostly just told their personal stories. All who had suffered from a lifethreatening disease had been emotionally shattered by the experience and seemed incapable of logic and constructive comments on how the needs of desperate people could be met without stripping consumers of reasonable protection from charlatans, hucksters, and deluded medical messiahs. Some others who testified were shameless promoters of unproven medicine themselves. Several politicians spoke in favor of the bill, mostly from their own limited personal experience with little attention to what the far-reaching effects of such legislation would be.

A State Senator from Georgia, who is a Burzynski disciple, proudly announced that he had gotten a law passed that was patterned after Congressman Peter DeFazio's "Alternative Access to Medical Treatment Act." In Georgia, a medical renegade now has to meet only two simple requirements: that he actually discusses orally with the patient the potential side-effects and what the outcome is, and he gets a written statement from the patient that he can practice alternative medicine without fear of the State Medical Examiners harassing him.

Rep. DeFazio also testified. DeFazio is fond of the German "two-track system." Someone even had arranged to have a German physician there to testify onbehalf of the idea. Peter Matthiessen, MD, is Head of the Dept of Medical Theory that monitors medicine and complementary medicine at the University of Witten/Herdecke. Matthiessen said that German legislators "did not take upon themselves the role of judging the adequacy of science, but spoke in support of existing pluralism in medicine." He believes that the value has been that a dialogue was quickly established that allowed them to distinguish between valuable and promising therapies and fraudulent ones. He commended the committee for developing a bill that would do the same in the USA. Matthiessen apparently did not realize that HR746 would not do that. Nor did he provide information on which methods were "valuable and promising," or how this had been determined. For details on why Germany is not a place that responsible people would want to emulate regarding unproven medicine see "A mothering ground of quackery" (NCAHF Newsletter , Nov-Dec, 1996), which shows that the region has historically been the worst on earth for spawning quackery.

It is possible that Germany's current extreme tolerance for medical pluralism is a reaction to its sad history of racial intolerance. If so, its new tolerance is misguided. Tolerance is a virtue when it comes religion, race, and politics, but not science. The ongoing function of science is to ferret out error. Scientific tolerance is limited to its openness to new ideas which is conditional. Theories must be testable, sound protocols must be followed, and results must be repeatable. Medical claims must be proved before they can be recommended for general use. Germany's medical pluralism has not led to a significant discovery. Further, the financial incentive for testing is greatly reduced when unproven treatments are allowed into the marketplace. Failure would lead to withdrawal, success would lead to imitation. The business decision would be to remain exclusive.

Sound reasoning made a showing.

The single exception to the parade of emotionally-distressed patients, proponents, and politicos was Thomas J. Moore, Senior Fellow, Health Policy Institute, George Washington University. Moore spoke directly to the impact of the bill under consideration. He noted that in this age of media hype it is quite plausible that millions of Americans could be persuaded to take a pill every day to prevent cancer, especially if it included a natural substance or vitamin. He pointed out that, even with its current tough standards, the FDA sometimes approves bad drugs (eg, fen-phen debacle). He also posed the following scenario:

Suppose you are dying of cancer, and I offer you this ghoulish shell game. In one of my hands, I have hidden a treatment that might save your life. In the other hand is a quack treatment that's probably going to make you so sick that you can't get out of bed; it will actually shorten your remaining days of life. And I'm giving you a free choice here; pick the hand that want; go ahead. Pick. Do some research. Check me out and see which hand you would like to choose. This is not a meaningful choice. Without extensive drug testing, we just can't tell which hand holds the dangerous poison, and which conceals the life-saving drug. I want people to have choices too, but they should be real choices involving scientific data. ...I agree with the testimony that there are important alternative therapies that are falling through the cracks of our system as we have designed it today, but I don't think the answer is to repeal the safeguards that are so important to public health.

In his conclusion, Moore stated that "the central issue before the committee today is not access to treatment, but assuring that the proper and necessary drug testing is conducted to insure that both mainstream medical therapies and alternative medicines help rather than harm people."

The strongest statement on behalf of reason was in the form of a letter from Rep. Edolphus Towns (D-NY). Towns stated that he was "a bit amazed about today's hearing topic of access to medical treatments 'beyond the FDA.'" Towns stated, "I am here today because this hearing is intended to encourage the use of experimental therapies on gravely ill people. Apparently, this committee is having a memory lapse or enjoys self-contradiction." Towns cited eleven hearings held earlier in the 105th Session of Congress that addressed the resistance of the Veteran's Administration and Department of Defense to accept the validity of socalled "Gulf War Syndrome." He wrote:

We reached one major unequivocal conclusion: the use of unapproved or investigational drugs should not have been allowed in a setting that prevented oversight, evaluation, and monitoring. In unanimously passing that report, this full committee shared that conclusion. Mr. Chairman, I believe that you voted in support of that report. Yet here we are today encouraging the use of unapproved, investigational therapies in settings that are without the appropriate oversight, evaluation, and monitoring. Now some will say that I am unsympathetic and have no compassion for the sick. Nothing could be further from the truth. Let's be clear. The FDA generally approves the applications of any patient who wants to use an investigational drug where the doctor agrees to conduct the proper evaluation. I know that a sick patient may be desperate and willing to try anything. I know that it is not fashionable, but I believe that the government has a duty to safeguard the best interests of its citizens, in sickness and health. There are some things that we simply cannot allow the free market to decide and the safety of potentially dangerous drugs is one of them.

Towns concluded his remarks by stating that "this hearing does not add to the discussion of health care in America. Today we walk ground previously trod by others and leave no meaningful impression."

Two Track System?

These hearings suggest that the basis for a two-track system would have to be emotion versus reason , or, accountability versus no accountability . A similar double standard already exists for the retailing of nonprescription medications as regular medicines are held to scientific standards while homeopathics, herbal remedies, and other dietary supplements are not. This outrageous situation is finally being challenged as people are becoming aware of the facts. The bottom line is that the sacred American equality principle is incompatible with a two-track system. Business people bring health products and services to the marketplace deserve a level playing field in which they may compete, and consumers (both sick and well) deserve equal protection under the law.


Newsletter contents copyright 1998, National Council Against Health Fraud, Inc.
Items may be reprinted without permission if suitable credit is given.

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