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September 1998 marks the zenith and the decline of alternative medicine. I say zenith because it is the focus of the current New England Journal Of Medicine. But it marks the decline for the same reason. After years of increasing popularity, we are now witnessing the first major counter-attack against alternative medicine by the orthodox medical establishment. The New England Journal, September 17, 1998 features six articles with a common theme: alternative medicine is unscientific, unregulated, and dangerous. Herbal therapies in particular are singled out and the editors call for increased FDA regulation and revision of the 1994 DSHEA (Dietary Supplement Health and Education Act), which permits natural products companies to label and describe what their products actually do. In case you haven't noticed, products now carry suggestive names, such as "sleep," "brain," "immune," and etc. Up until 1994 this was illegal and products were seized by the FDA for making claims.

The most poignant of the six articles is a letter to the editor by doctors from Canada voicing their concerns about alternative therapies for the treatment of childhood cancer. Their two cases illustrate the difficult choices parents face when there is no definitive cure but conventional treatment is likely to be unpleasant and debilitating and the alternative is not. In the first of these cases, a 15 year old boy with Hodgkins Disease elected to try an herbal combination containing astragalus, colostrum, and whey, rather than chemotherapy. The manufacturer promotes its possible benefits against chronic fatigue, cancers, AIDS, and hepatitis C, but not Hodgkin's Disease. Nevertheless, from April until August the patient took the herbal therapy. During that 4 month period his Hodgkins unfortunately worsened a degree, from stage IIA to IIB, and now requires more intensive therapy. Whether the delay affected his long-term prognosis is not yet known. 

The second case concerns a 9 year old female child after brain surgery for neuroectodermal tumor. The three year survival after chemotherapy and radiotherapy is said to be over 50 percent. Nevertheless the parents chose to treat their daughter with shark cartilage instead. Four months later the tumor had progressed and the patient died (time interval not specified). The authors conclude that there is "...a responsibility to educate the public not only about the great benefits of evidence-based medicine but, in addition, about the risks of using therapies for which any evidence of safety is lacking." 

Is it possible that parents are unable to appreciate the risks inherent in alternative therapies? Many patients don't really appreciate the risks or statistics relative to conventional treatments either. In Barrie Cassileth's research, comparing outcomes at an alternative cancer clinic in San Diego with the oncology service at University of Pennsylvania, there was no significant statistical difference in survival or quality of life outcome between approaches.[i] Of course, it is unwise to draw conclusions from just two cases, as in these two cases from Alberta Children's Hospital. I trust that these physicians are not calling for the removal of alternative treatments, for in the mind of a patient, loss of choice is almost as stressful and unhealthy as loss of hope.

The lead article in the Journal describes PC-SPES, a Chinese herbal combination containing:

1. Chrysanthemum, which contains labile methyl groups

2. Isatis (contains an indole antibiotic indigo blue dye)

3. Licorice (an adrenal hormone adaptogen)

4. Ganoderma lucidum (an immune-stimulating mushroom)

5. Panax pseudo-ginseng (contains ginenosides, not sterols)

6. Saw palmetto (inhibits testosterone and DHT production in prostate cells)

7. Scutellaria (antibiotic and inhibits cell-mediated allergy and inflammation,

8. Rabdosia rubescens (Rich in estrogenic sterols, I presume. Not in my books).  

This patented product was investigated and found to contain powerful estrogenic hormones, with effects at 1 to 200 dilution that are identical to 1 nM of estrogen[ii]. More to the point, eight prostate cancer patients taking the product had dramatic lowering of testosterone and PSA test results. The authors also found that PC-SPES inhibited prostate tumor cells and breast tumor cells in cell culture. 

Based on this research, one might consider this article to be a good advertisement for herbal medicine; however to counter that impression the abstract ends with the conclusion: "The use of this unregulated mixture of herbs may confound the results of standard or experimental therapies and may produce clinically significant adverse effects." The New York Times review of the subject features a horrendously distorted headline: "Articles Question Safety of Dietary Supplements. Use can endanger lives of ailing people." The New York Times certainly got that message. On the other hand, as a practicing physician I am in agreement with the Hippocratic principle: "First, do no harm." Product safety is a primary issue. To my mind, the immediate question is, why, after almost a century of regulatory experience, is the FDA failing at its job of ensuring food and drug safety?

For example, in this same issue of the Journal a case of product contamination was published by a team from the FDA Center for Food Safety and Applied Nutrition.[iii]The patient became ill soon after using an "internal cleansing" product in 1997. She was hospitalized with a serious cardiac arrhythmia (heart block) after 5 days on a regimen containing 14 herbs plus colostrom, digestive enzymes (amylase and cellulase), bentonite (an absorbent clay), a variety of probiotic lactobacillus organisms in an inert starch medium (FOS), and psyllium husk powder. Psyllium is made from the seeds of plantain (plantago ovale), and it is a popular remedy for constipation at the supermarket and pharmacy as well as at the health food store. 

After a day the patient was overcome by lethargy, nausea and vomiting. Undaunted, she continued the treatment for a few days longer, until the onset of irregular heartbeats and hot flashes sent her to the emergency room. The alert medical staff made the correct diagnosis, the patient recovered in 5 or 6 days more, and the FDA tracked the product all the way to Germany, the source of almost 3 tons of plantain shipped to the US in the previous two years. Samples were tested in Germany and found to contain cardiac glycosides, related to the active ingredients in digitalis, a common heart drug. Originally digitalis was found in the herb, foxglove, but other herbs also contain these molecules, including the common oleander, which beautifies the highway medians and the landscape of California. 

The FDA team tracked the plantain within this country to over 150 retailers. Recalls were conducted 13 times from manufacturers and distributors, and eight distributors received warning letters from FDA. Press releases were posted at the FDA Web site. Nevertheless, only one other case was located, this one considerably milder, but the products ingested by the two patients had been produced by a single manufacturer and had the same lot numbers. Does this raise the question that the contamination might have occurred in the United States and at this manufacturing plant?

Another question is whether the contaminated plantain was part of the 14 herbs in the end-product, or was it in the psyllium. Did the bulk plantain from Germany contain other herbs, such as foxglove, squill, and oleander. Perhaps one or more of these grew in the same fields with plantain and were harvested with it. Or was the digitalis in the processing equipment and left behind as residue due to failure to clean the mixers from one product run to the next. I have inspected a few manufacturing plants and this doesn't seem likely. Finally, is this case report a rare example or is it a common hazard?

I don't know the answers to these questions, and I think it is unfair to our patients and other consumers to leave them unanswered. Many people truly depend on plantain as a source of food fiber and a remedy for constipation. I think doctors should know more about these things. If governmental and medical authorities elect to publish such case reports, it would be appreciated if they would also share enough information so that we can judge the long-range probability of repeat accidents. In the absence of such knowledge, the prudent patient will avoid psyllium altogether and the wise physician will not prescribe it. The quality of medical practice and general health is likely to suffer if such ignorance and fear are all that we have to guide us. 

The FDA team almost certainly knows this; so why are these facts not included in the report. The information must have come out of the investigation. Instead the report concludes with a political message, one with which I agree only in part. Namely, that the FDA should be concerned with safety issues relative to dietary supplements. This is so fundamental an issue, so primary to the FDA mandate, that I doubt any significant legal objection would or could be mounted against a program to improve safety in supplements program by FDA. Contamination and poisoning issues in particular are just plain common sense. The American people want to be protected against food poisoning and product contamination. 

A letter to the editor appeared in this same issue, authored by Richard Ko, of the California Department of Health, Food and Drug Branch, and titled "Adulterants in Asian Patent Medicines." Dr. Ko analyzed 260 Asian patent medicines and found 32 percent contained pharmaceuticals or heavy metals. Twenty four products (almost 10%) contained lead (10 to 319 mcg per gram); Thirty six (14%) contained arsenic (20 to 114,000 mcg per gram); Thirty five contained mercury (22 to 5000 mcg per gram). The official limit is well below 30 mcg for all of these toxic metals. Clearly there is a problem now and sporadic reports have been appearing years. The problem has been recognized. Why hasn't FDA taken the initiative to solve it before now? Why does this very convincing summary of a major research documentation of the extent of contamination appear only as a short letter to the editor? Why has FDA not already convinced overseas producers, including those in China and India, to clean up their act and purify their product? Please don't blame "alternative" medicine! Put the blame where it belongs.

The FDA is already mandated to protect us. Why are we thinking of expanding their mandate when they are not keeping up with their present responsibilities. Better to bring this out in the open and find out why companies are asked to spend hundreds of millions to prove a drug works, while much less attention is focused on safety. Wouldn't it be smarter to let the doctors, patients, and researchers determine if products work?! That would make it possible for FDA to put safety first, not only relative to contamination, but also in the important issue of pharmaceutical adverse effects.

For example, in 1996 alone, over a hundred thousand patients died from adverse reactions to FDA-approved drugs in America's hostpials.[iv] The total number of adverse reactions is estimated at over 2 million per year. And these tragedies are all AFTER FDA approval! We need to reconsider the purpose of FDA and get our priorities straight: safety first, efficacy second. That's really what needs to be discussed. We don't expect drugs to cure, only to help. But we do expect our foods and our drugs to be safe and not to make us worse.

The need for regulation of food and drug products is dramatically evident in another case report, this one by Dr. Y. Beigel[v]and colleagues from Israel, who describe a 42 year old businessman with a complaint of abdominal pain and anemia, which was ultimately diagnosed as lead poisoning. The source of metallic lead was traced to a health product from India, an herbal treatment for diabetes. The patient took 8 tablets a day, each containing 10 mg of lead, for about 3 months before entering the hospital. His total lead intake may have been as high as 4 thousand milligrams. The article ended with a question: "Could the diagnosis have been made earlier, and some of the elaborate tests avoided?" The authors answer that patients do not consider herbal medications to be drugs and almost 3 out of 4 patients do not inform their physicians. So doctors even in Israel do have trouble with diagnosis when it comes to natural health products. 

I am sure that an orthomolecular physician would have gotten the diagnosis much sooner, because the typical initial work-up of a nutrition physician includes a mineral panel, including lead, mercury, cadmium, arsenic, thallium, and lithium testing. I have diagnosed otherwise obscure cases of all of these toxic metals over the years because of my routine practice of testing for them as part of an extensive mineral panel that includes both toxic and physiologic (healthful) minerals, such as calcium, magnesium, zinc, copper, manganese, selenium, chromium, molybdenum, vanadium, boron, and sulfur. The physiologic minerals offer valuable clues about one's nutritional and metabolic health status. These can be studied in whole blood, red blood cells, urine, and hair. No one source is complete or trustworthy and experience and good clinical judgment are important. In my opinion, the quality of medical practice is much enhanced by the use of such testing.

However, the editors of the New England Journal take a different stance in their editorial: "Alternative Medicine--The risks of untested and unregulated remedies. (page 839-41. "What sets alternative medicine apart, in our view, is that it has not been scientifically tested and its advocates largely deny the need for such testing." "It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine--conventional 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…Alternative treatments should be subjected to scientific testing no less rigorous than that that required for conventional treatments."

I agree with that conclusion; however, who is to do the testing? Who is to pay for it? Clinical research is expensive. When the California legislature allocated about $150,000 for a study of vitamin therapy at Napa State Hospital in 1978, the human subjects committee objected on the grounds that the money was insufficient to mount a serious study with credible conclusions. In my role as psychiatric consultant to the project I was close enough to the treatment ward to know that patients were improving on vitamin therapy and that the average requirement for psychotropic medication was cut in half; but I did not have access to the data analysis until years later, and we were forbidden to publish!

According to the editorial by Drs. Marcia Angell and Jerome Kassirer, "Of all forms of alternative treatment, the most common is herbal medicine." The citation for this conclusion is a New York Times article by Jane Brody, the Times nutrition editor. As is often the case, I disagree with her opinions. In this case, I would wager that diet therapies are more common than herbal treatments--but they have been erased from the picture of alternative medicine. In fact, Jane Brody contributed to that blackout in 1981 by condemning orthomolecular medicine as quackery.  

Meantime, it is painfully clear that without a scientific foundation, alternative medicine will be subjected to criticism, attack, over-regulation, and eventual decline into degradation. The public will lose confidence in herbalism, imagery, massage, and chiropractic as mainstream medicine fights back with lots of new drugs and machines, claiming exclusive rights to a new generation of physical electronic and electro-magnetic therapies. The history of human progress favors the path of technology, regulated by authority.

What I am getting at is that Linus Pauling and Orthomolecular Medicine were the first wave of nutrition medicine to make a serious impact on the medical establishment because of our link to basic science. As a result Pauling, a Nobel laureate in chemistry, was ridiculed. And orthomolecular medicine was branded as quackery in bold print in the New York Times in 1981 by the very same Jane Brody who now tells us that herbalism is the core of alternative medicine. Orthomolecular Medicine has been wished out of existence by the very people who need it most--the medical establishment: medical schools, medical boards, and everyone on the medical-hospital health team.

The paradox is that nutrition, the most neglected part of "alternative" medicine, is also the most scientific. Orthomolecular nutrition is based on principles of physiology, biochemistry, and clinical medicine and is supported by many scientific studies. There are literally thousands of research and clinical research papers on the medical use of nutrients. While there are not yet enough controlled studies to pin down the details of diagnosis, prognosis, and treatment sufficient to establish orthomolecular nutrition as the predominant strategy in medical practice, there is little doubt in my mind that we are headed in that direction. Contrary to the opinion of the editors of the New England Journal, the orthomolecular physicians are eager to cooperate with research studies. However there are few in private practice with the time or money to support assistants, statisticians, and other personnel for research in the setting of the private medical office. Furthermore, critics are likely to attack such studies as unethical if they involve the payment of a fee at the same time that the doctor is writing up the results for publication. The fact is that medical research has become institutionalized. The medical establishment has to raise the money and do research in their clinics, clinics which now compete directly with private practice for patients and income.

Despite the fact that nutrition medicine is in its infancy, the weight of clinical experience in the past 60 years is favorable and convincing. Many studies support the use of vitamin C, vitamin E, magnesium, omega-3 fatty acids, folic acid, B12, B6, zinc, chronium, selenium, vanadium, niacin, riboflavin, biotin, carnitine, lipoic acid, glutamine, glucosamine, RNA, carnosine, histidine, threonine, tryptophan, tyrosine, branched chain aminos, arginine, to name a few nutrients that have been demonstrably effective against one or more medical conditions. And that does not mention the established value of a large number of herbs, singly or in combination: ginkgo, ginseng, eleuthrococcus, glycyrrhiza, ginger, garlic, oleuprein, anthocyanidins,--the list goes on and on. And that does not include essential oils, and special foods, such as shark cartilage, thymus, and organ meats (a Nobel prize was given to Minot and Murphy for curing pernicious anemia with daily meals of liver!). 

In fact, there would be no "alternative medicine" if there were not first an orthomolecular foundation created by a handful of dedicated physicians in the 1970s and 1980s. The title, 'alternative,' provides safe-haven because until now it has been tolerated by medical boards. This is not the time to attack vitamins, minerals, and herbs. It is a time to respect our physicians who incorporate these modalities into medical practice. Without these orthomolecular physicians, the public have no choice. My patients vent their frustrations and tell me that they resent the lack of nutrition knowledge of M.D. physicians. Instead they are seeking the counsel of acupuncturists, chiropractors and nutritionists.

Yes, it is time to promote studies to spell out the limits--and the dangers--of alternative practices. The support should come from the government and from philanthropic foundations. The Society for Orthomolecular Health Medicine, of which I am president, is a tax-exempt, educational institution, engaging hundreds of physicians and other health professionals in a multi-disciplinary educational and research effort. We would be grateful for research funding to sponsor much-needed nutrition research in almost every area of medical practice. Some studies can't be done in the laboratory as well as in the clinic; and they can't be done as well by graduate students and professors. There is a place for clinical research and it is important to respect this traditional function of the physician. We in orthomolecular medicine are trying to provide advances in health care that are sometimes labeled "alternative." Nutrition is not an alternative, it is essential to health and therefore to good medical practice.

© 2011 Richard A. Kunin, M.D.

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[i] Cassileth BR, Lusk EJ, Guerry D, et al. Survival and quality of life among patients receiving unproven as compared with conventional cancer therapy. N Engl J Med 1991;324:1180-5.

[ii] DiPaola RS, Zhang H, Lambert GH et al. Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. N Engl J Med 1998;339:785-91.

[iii] Slifman NR, Obermeyer WR, Aloi BK et al. Contamination of botanical dietary supplements by digitalis lanata. 1998, N Engl J Med, 339:806-811.

[iv] Xx xx: Incidence of adverse drug reactions in hospitalized patients. 1998, JAMA, xx-xx. (4/15/98)

[v] Beigel Y, Ostfeld I, Schoenfeld N. A leading question. N Engl J Med, 1998, 339:827-890.

 

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