Last week I received the news release below that Steve Zeitzew, an orthopedic surgeon at VA Hospital Los Angeles and UCLA, sent to the Healthfraud list. It was sent to me by our colleague Liz Woeckner, President of the nonprofit research protection advocacy organization Citizens for Responsible Care in Research (CIRCARE) http://www.circare.org/
Ms. Woeckner sent it on with a cryptic comment, wondering if this action was a quid pro quo for the Chinese granting less than a dozen FDA “inspection stations” in Chinese cities. The latter is supposed to be an attempt to control the impurities and adulterants of Chinese herbal products.
But before proceeding, read for yourselves:
Monday, June 16, 2008 Contact: HHS Press Office
HHS Secretary and Chinese Minister of Health Sign Memorandum of Understanding on Traditional Chinese Medicine Research .
HHS Secretary Mike Leavitt today signed a memorandum of understanding with Chinese Vice Minister of Health Wang Guoqiang to foster collaboration between scientists in both countries in research on integrative and traditional Chinese medicine. The signing marks the opening of a two-day traditional Chinese medicine Research Roundtable at the National Institutes of Health (NIH). The roundtable features scientific presentations by researchers from China and the United States. Topics include the synthesis of Western medicine and traditional Chinese medicine, criteria for evaluating traditional Chinese medicine practices, and the application of modern scientific tools such as proteomics (the study of proteins) to the study of traditional Chinese medicine. “Many Americans incorporate alternative medical practices into their personal health care and are interested in the potential of a variety of traditional Chinese medicine approaches,” Secretary Leavitt said. “This project will advance our understanding of when and how to appropriately integrate traditional Chinese medicine with Western medical approaches to improve the health of the American and Chinese people.” The memorandum of understanding and the establishment of the international collaboration will aid in furthering scientific research on traditional Chinese medicine. Participants in the roundtable include a delegation from the Chinese State Administration on Traditional Chinese Medicine, academics from U.S. universities, and scientists and researchers from NIH, Indian Health Service and the Food and Drug Administration (FDA). Thirty-six percent of Americans use some form of complementary and alternative medicine (CAM), according to the 2002 National Health Interview Survey. In the United States, traditional Chinese medicine is an alternative medical system that is considered a part of complementary and alternative medicine. Integrative medicine combines mainstream medical practices with alternative medical practices. Traditional Chinese medicine involves numerous practices including acupuncture, tai chi, and herbal therapies. In 2007, NIH’s National Center for Complementary and Alternative Medicine (NCCAM) supported nearly $20 million in research on traditional Chinese medicine practices. Secretary Leavitt was joined at the signing by FDA Commissioner Andrew von Eschenbach, M.D., and NCCAM Director Josephine P. Briggs, M.D. The roundtable, which was coordinated by NCCAM, National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine and the Fogarty International Center, is being held in advance of the Fourth Session of the United States-China Strategic Economic Dialogue, which began today in Annapolis, Md.
The “Science” and Ethics of “Natural Medicines” (and Nutrition) cont.
This is the continuation of a discussion concerning the explicit claim of “naturopathic physicians”* to being experts in the use of “natural medicines,” defined as “medicines of mineral, animal and botanical origin.” Last week’s post established that the cult has chosen to profit from the “retail selling of medications,” as evidenced by the relevant Position Paper of the American Association of Naturopathic Physicians (AANP) and by that organization’s having made a deal with a drug company to make profits for both itself and its members.
The Position Paper observes that such selling “could be construed as a conflict of interest on the part of the physician.” That is true, if embarrassingly understated: anyone representing himself as a physician, who both recommends and sells the same medications for a profit, has conflicting interests. The conflict undermines his claim to offering responsible advice regarding those medications, and as such is a breach of medical ethics.
The AANP’s deal with MotherNature.com was even worse: by promoting such peddling in a formal, institutional fashion, NDs and their national organization went beyond the already widespread problem of practitioners hawking drugs. It is unclear whether the deal still exists, by the way: MotherNature.com was a victim of the “dot com” bust of a few years ago. It has since been resurrected, but a quick perusal of its new website fails to reveal the old AANP relationship. Nevertheless, I have seen no evidence to suggest that the AANP has changed its view of that sort of deal.
Are NDs Truly “Learned Intermediaries” in the Use of “Natural Medicines?”
This entry discusses the other part of the claim of expertise: that, aside from their conflicting interests, NDs have real knowledge of “natural medicines.” It will become clear during the discussion that the purported naturopathic expertise in nutrition—another standard claim—is also under review. I will include or cite abundant evidence for my assertions, because I’ve found that a predictable response of representatives of the highest levels of “naturopathic medicine” is to flatly deny them. I apologize again for including excerpts from previously published material.
The “Science” and Ethics of “Natural Medicines”
This and the next entry in the current “Naturopathic Medicine” series* deal with the cult’s claim of expertise in “natural medicines” or “natural remedies.” These include herbs (“botanicals”), glandular extracts, vitamins, and minerals. A large fraction of the Textbook of Natural Medicine (TNM), “the most thoroughly researched and carefully referenced text on natural medicine,” is devoted to these agents. They are keys to the practice of naturopathy and to a core claim of “naturopathic physicians” that legislators tend to swallow: that NDs offer something that most MDs do not.
During the deliberations of the Massachusetts Special Commission, NDs produced Dr. Alan Trachtenberg, a fresh-faced ingenue who had briefly been Acting Director of the federal Office of Alternative Medicine, to testify on their behalf. He suggested to the Commission that naturopaths could be the “learned intermediaries” that the public needed to help make sense of the myriad “natural remedies” that became freely available in the wake of the Dietary and Supplement Health and Education Act of 1994 (DSHEA). This is from his written testimony:
Another advantage of state licensure, is that the holder of a professional license who provides or recommends a product, then becomes responsible for the quality and safety of a product. In an unregulated marketplace, such a learned intermediary can be invaluable to the consumer. Since naturopaths do often provide dietary supplements and herbal products directly to their patients, it is vital that they have an enforceable code of professional ethics. Such a code of ethics becomes enforceable with State licensure.
It is also beneficial for the patient to have a practitioner who knows enough about biochemistry, physiology, pharmacology, and physical diagnosis to adequately assess a patient’s clinical response to a product. These products are essentially complicated but unregulated drug mixtures. My understanding is that licensable naturopathic doctors have all taken these courses during their four years of training and passed standardized exams that test their mastery. There is no such quality assurance for the other kind of naturopathic practitioner.
Instead of relying on Dr. Trachtenberg’s “understanding,” let’s submit his two assertions—that of a “code of ethics” and that of “mastery” of the topic of “natural medicines”—to real scrutiny. In doing so I confess that I have plagiarized, to some extent, pieces that I’ve written elsewhere.
In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.
The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.
This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.
The story of Airborne – a popular supplement marketed as an “herbal health formula that boosts your immune system to help your body combat germs” – is representative of what is wrong with the supplement industry and how it is regulated in the US. Recently the company that sells Airborne – Airborne Health, Inc – agreed to pay $23.3 million to refund consumers who purchased the product (if they have proof of purchase). This was to settle a class-action law suit brought by the Center for Science in the Public Interest (CSPI) and others claiming false advertising. In the settlement the company did not admit any wrongdoing. While this can be viewed as a minor victory for science-based medicine, it actually highlights the many deficiencies in the system.
For background, Airborne was launched in 1999 as a supplement designed to ward off the common cold. It has been extremely successful, due largely to its slick packaging, a clever slogan that it was developed by a school teacher, and promotion by Oprah Winfrey. The Airborne brand of products has expanded, including pixie powder for children, Airborne seasonal, Airborne Jr., Airborne on-the-go, and others. Advertising urged users to take Airborne at the first sign of a cold or as a preventive treatment if about to enter a germ-filled area, like an airplane. They also cited a “scientific” study that demonstrated Airborne is effective.
One of the most successful propaganda campaigns within health care in the last few decades has been the re-branding of nutrition as “alternative” or out of the mainstream of scientific medicine. I have marveled at how successful this campaign has been, despite all the historical evidence to the contrary. I suppose this is partly a manifestation of the public’s short-term memory, but it also seems to reflect basic psychology.
There is evidence that most ancient cultures recognized the importance of diet in health. The Greeks recognized both the benefits of a varied diet and the negative health consequences of obesity, for example. But knowledge of nutrition was limited to these broad observations and was mixed with superstition and cultural beliefs.
The science of nutrition probably dates back to 1614 when scurvy (the disease that results from vitamin C deficiency) was first recognized as a dietary deficiency, one that could be cured by eating fresh fruits and vegetables. In 1747 Lind conducted what might be the first clinical trial – systematically comparing various diets for the treatment of scurvy and finding that citrus fruits were the key to treatment.
When I recently wrote about glucosamine, I discussed the evidence up through the New England Journal of Medicine study of 2006, which I thought was a pretty definitive study showing that neither glucosamine, chondroitin or a combination of the two was more effective than placebo. Subsequent studies have continued to fuel the controversy. One 2007 study showed that glucosamine sulfate was better than placebo for knee osteoarthritis. Another 2007 study showed that glucosamine HCl and chondroitin, with or without exercise, were no better than placebo for knee osteoarthritis. Sources like the Natural Medicines Comprehensive Database believe the evidence favors glucosamine sulfate but not glucosamine hydrochloride.
A new study was published 19 February 2008 in the prestigious Annals of Internal Medicine. It is arguably the best study to date, and may shed some light on the controversy. Carried out in the Netherlands in a primary care setting, it studied 222 patients with hip osteoarthritis over a 2 year period. Half the patients took glucosamine sulfate 1500 mg a day; half took a placebo. They concluded that glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis. (more…)
The core principle of science-based medicine is that health care decisions should be based upon our best current scientific evidence and understanding. When applied to the regulation of health products this means that health claims should first be required to meet some reasonable threshold of scientific evidence before they are allowed. Admittedly this is not a purely scientific question but the application of scientific knowledge to an essentially political question – the balance of protection vs freedom.
Regardless of where one thinks this balance should be, I think most would agree that is it a problem if the public generally wants more protection than it is getting, or believes it is currently getting more protection than it is. A Harris poll from 2002 indicates that the majority of Americans believe that companies cannot make health claims about supplements unless they have been proven scientifically and approved by the FDA, when in fact this is not the case. The Dietary Supplement Health and Education Act of 1994 (DSHEA), largely through the efforts of Senator Orin Hatch from Utah, removed supplements from the control of the FDA and specifically allowed for so-called structure function claims to be made about products without any burden of proof. Most Americans are not aware of this fact.
A new study by lead author Shelly Gray and published in the latest issue of the Journal for the American Geriatric Society, found no effect from taking Vitamin C or E, either alone or in combination, on the risk of dementia or Alzheimer’s disease after 5.5 years. Vitamins C and E were chosen because they both have significant antioxidant activity, and so this study was partly to test the hypothesis that oxidative stress causes or contributes to dementia.
The science behind the role of oxidative stress in aging and neurodegenerative disorders and the modulation of oxidative stress by nutritional antioxidants is complex and has not yielded many confident therapeutic recommendations. And yet, by contrast, antioxidants are sold to the public with dramatic health claims as if they were well established. It is common for marketing hype to out pace scientific reality, especially when the science is complex and preliminary so that there is as yet no firm scientific consensus.
For background, oxidative stress refers to the production in the cells of the body of certain oxygen-based compounds, collectively called reactive oxygen species (ROS), that are highly reactive. Some of these compounds are simply waste products of cell metabolism. Others serve a useful purpose, such as nitric oxide that is used in neurotransmission. What these ROS compounds have in common is that they react with proteins, DNA, and other cell components and cause damage.
Glucosamine and chondroitin, used separately or together, are among the more popular diet supplements. They are used widely for osteoarthritis, especially of the knee, and have been better studied than most other diet supplements. But do they really work?
The journal of my medical specialty, American Family Physician, recently published an article about the use of dietary supplements in osteoarthritis. They gave a “B” evidence rating to both glucosamine and chondroitin. This means there is inconsistent or limited-quality patient-oriented evidence. They recommended the use of glucosamine sulfate, saying, “Overall, the evidence supports the use of glucosamine sulfate for modestly reducing osteoarthritis symptoms and possibly slowing disease progression.” They did not exactly recommend chondroitin, although they said it “may provide modest benefit for some patients.”
I remain skeptical. And so does R. Barker Bausell, who devoted several pages of his book Snake Oil Science to an analysis of the research on glucosamine and chondroitin. (more…)