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Editorials

MSNBC Report On Supplements Is Biased And Factually Inaccurate
18 April 2001
by Wyn Snow, Managing Editor

The MSNBC news story entitled "Unsafe supplements?" authored by NBC News correspondent Robert Hager that appeared on MSNBC.com on April 10th is overflowing with questionable points, some of them factually inaccurate, and is therefore misleading. Detailed commentary on specific points follows below.

Story claims public health is endangered -- but FDA has authority to act

The overall thrust and conclusion of the MSNBC story is that public health is being endangered by "lack of industry oversight" and that more regulation is needed. Yet the FDA does have the authority to remove dangerous products from the marketplace. For example, the FDA has tried on several occasions to prove that ephedra is dangerous and should be removed from the market, yet has not succeeded in proving its case. Indeed, at least one senior official within the FDA has testified before Congress that the agency has sufficient authority to act, if such action is warranted.

With 150 million Americans taking supplements, I suggest their interests are better served by calls for increased funding of research so that supplement use is based on science rather than anecdotal evidence bandied about by both pro- and anti-supplement points of view. In this respect the MSNBC article seems more like the representation of a third-party point of view than carefully researched reportage.

Relative dangers of supplements and pharmaceutical drugs

In writing about the supposed dangers of supplements -- whose safety record remains to be seriously challenged -- the media ignores the real pink elephant in the middle of the room. The pharmaceutical industry is highly regulated and has plenty of government oversight. Companies are required to have absolute proof of efficacy and absolute proof of safety before a product can be brought to market, through research that costs upwards of $250 million per product. Yet despite such "absolute proof of safety and efficacy," approximately 100,000 Americans die each year from properly prescribed pharmaceutical drugs.

I understand that allopathic medicine and pharmaceutical research have revolutionized trauma and clinical care in our time. I also understand that errors and unforeseen consequences are side effects of a medical practice serving the entire nation. But I am compelled to note that if the vast majority of American adults are consuming supplements (see Kaiser Family Foundation data), then elementary logic infers that our government, our universities, and news organizations such as MSNBC should recognize the opportunities as well as the risks contained in this fact.

What potential for gains in personal health and wellness, in quality of life and economic productivity are contained in enhanced nutrition and supplementation? What are the implications of a healthier America for an economic environment in which medical costs are cannibalizing an ever-growing portion of the total economy? What benefits might accrue from stimulating use of scientifically proven supplementation regimens among consumers who are apparently already convinced that supplements are beneficial?

Real issue is social values reflected in allocation of research funding

The real issue is not one of regulation or stirring up fear and anxiety in the public arena. Consider: What social values are reflected in an NIH budget that allocates to supplements substantially less than 1% of the amount expended annually for medical and health research?


Commentary

FDA not informed of adverse reactions -- by state poison control centers

The story said, "The government doesn't hear about the vast majority of health problems associated with dietary supplements, according to an unpublished report from the inspector general of the Department of Health and Human Services."

The Inspector General's report demonstrates that government's right hand isn't talking to government's left hand -- in particular that state Poison Control Centers aren't communicating with the federal Food and Drug Administration.

Even though the story merely reports on and quotes the Inspector General's report, it neglects to point out that communication channels can easily be established through administrative procedures -- and thereby provide whatever information is appropriate to protecting public health. Such administrative procedures would be easy to establish even in states where poison control centers are private rather than public.

FDA unable to determine ingredients in products -- but ingredients must be listed on product label

The MSNBC story states that the FDA "was unable to determine the ingredients in 32 percent of the products mentioned in adverse event reports."

Did they read the label? According to the FDA's own regulation, as of March 23, 1999 dietary supplement products must include an information panel titled "Supplement Facts"; all ingredients in the product must be declared in the ingredient statement or within the "Supplement Facts" panel.

In fact, "Supplements have been required to state their ingredients for decades," according to Roy Upton, Executive Director of the American Herbal Pharmacopoeia. "Supplements have always been regulated as foods, which are required to list ingredients in descending order of predominance." The Dietary Supplement Health and Education Act (DSHEA) of 1994 established dietary supplements as a new category distinct from both foods and drugs.

Poison control centers receive 13,000 reports of reactions to supplements

The MSNBC story says "in a recent year when the FDA received 470 reports of bad reactions to dietary supplements, the nation's poison control clinics actually treated 13,000."

How accurate are these 13,000 case reports? The poison control center in Massachusetts states that of the 24 poison-related deaths in 1997, "citation of a drug or chemical does not necessarily imply that these agents were the cause of death." This statement suggests that reports to poison control centers may be just as anecdotal, unverified, and vulnerable to errors as the FDA adverse event reports, which are also vulnerable to fraud because they are anonymous.

Also, even if these 13,000 reports of adverse reactions are indeed accurate, this represents less than one-hundreth of one percent of the 150 million Americans taking supplements, or approximately one person out of 11,536 -- which can reasonably be interpreted as evidence of an excellent safety record of supplements.

Anonymous experts characterize botanical supplements as having dangerous side effects

In the MSNBC story, anonymous experts say that "ephedra may cause blood pressure problems and strokes, ginkgo biloba can lead to excessive bleeding, while St. John's wort may block the effectiveness of anti-viral drugs."

Who are these experts? It is not surprising that botanical products have side effects. So do all OTC drugs, including aspirin. Indeed, some of these so-called side effects can be beneficial.

According to Roy Upton of the American Herbal Pharmacopoeia, "The fact that ginkgo thins the blood may justify its use in preventing stroke (as aspirin is used), but in addition (unlike aspirin) perhaps memory will be enhanced and it will provide antioxidant benefits. With St. John's wort enhancing cytochrome P-450 activity, this may mean it can be used to enhance the body's detoxification of potentially toxic drugs, and that the dosage can simply be increased accordingly when used with other medications."

Interactions and side effects of this kind are what label warnings, pharmacopoeias and desk references are for. There are many references accessible to consumers for a universe of supplement products. And appropriate warnings, as previously noted, can be as close as the label on supplement bottles.

Experts disagree about dangers of ephedra

The MSNBC story states "Research on ephedra that was commissioned by the FDA concluded that the supplement poses risks that far outweigh any benefits it might have. Results were published last November in The New England Journal of Medicine."

This NEJM article (published in December, not November) was not new research; instead it analyzed the unreliable and unverified anecdotal reports collected by the FDA. This is not unbiased research, nor do all experts agree with the NEJM article's conclusions.

According to Grover M. Hutchins, MD (an anatomical pathologist and paid consultant to the Ephedra Education Council), his analysis of 22 reports from the same FDA data in which death occurred indicates that these data "showed no consistent clinical or pathological features of the reported adverse events and showed that ephedrine-type alkaloids were not likely to have been causative or contributing factors in the deaths. ... With an adequate explanation of the reported adverse events, the implication of ephedrine-type alkaloids in deaths from a wide variety of conditions that occur in the general population is no more than idle speculation." (Source is correspondence published in the NEJM; the NEJM study's authors then rebut Hutchins' rebuttal; the two letters make interesting reading about the medical meaning of the term "cause of death.")

Center for Science in the Public Interest makes erroneous claim

In the MSNBC story, Bruce Silverglade (of the Center for Science in the Public Interest) says, "Right now consumers are playing a game of Russian roulette because no one is sorting out products that work from those that don't."

This is factually untrue from two points of view: both efficacy research and testing.

A number of supplement manufacturers do conduct efficacy research. Also, two agencies in the federal Department of Health and Human Services (DHHS) are cofunding efficacy research: the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, formerly the Office for Alternative Medicine. We reported on NCCAM research last June. Also, the Office of Dietary Supplements has created a database of research about dietary supplements -- IBIDS -- which now contains more than 400,000 unique bibliographic records about dietary supplements from 1986 to the present.

Concerning testing of products to determine "which work," ConsumerLab.com compares products with formulations shown to be effective in clinical trials, and several other organizations are developing third-party testing and certification programs. We have described ConsumerLab's work, NSF International's nascent certification program, and keep a page that lists ConsumerLab's currently available test results.

Double-blind, placebo-controlled research characterized as "industry-financed"

The MSNBC story also says that "While the FDA has received claims of 70 deaths among ephedra users, an industry-financed study turned up no problems."

By characterizing Dr. Carol Boozer's study as "industry-financed," the story implies that the FDA's reports are more accurate or reliable. Instead, the FDA reports are anecdotal at best -- while Boozer's study is an example of "the gold standard" of research: a randomized, double-blind, placebo-controlled clinical trial. This is exactly the kind of research that Bruce Silverglade, who is quoted in the MSNBC article, says isn't being done. Also, virtually all pharmaceutical research is "industry financed," yet no one denigrates this research on those grounds.

While several herbal companies contributed funding to Dr. Boozer's study, the funding was indirect; the money went through Science Toxicology and Technology, an independent consulting firm of physicians and toxicologists based in San Francisco that funded her research. This is not unlike charitable contributions being distributed by United Way, or a consortium of herbal companies underwriting the tasks and expenses of the Institute for Nutraceutical Advancement, which develops rigorous testing methods for botanical products.

Researcher's credentials minimalized

The MSNBC story quotes Dr. Boozer accurately as saying, "The bottom line is that in our studies we found that there were no real health consequences, significant health consequences, to individuals that were taking these products," and give her affiliation with the New York Obesity Research Center.

However, the story neglects to mention that the New York Obesity Research Center is further affiliated with Columbia Medical School, an organization with some prestige and a solid reputation.

According to the same NEJM article mentioned above, 12 million people took ephedra in 1999. Dr. Boozer points out that whenever 12 million people do the same thing (such as get haircuts, drink water, take aspirin, or drive to work), some will get heart attacks, high blood pressure, or strokes -- and some will die for reasons both directly and indirectly associated with the activities in which they are engaged.

Do we then conclude that haircuts, water, aspirin or driving to work caused the heart attacks, high blood pressure, strokes and death? No! To distinguish between coincidental and causative connections, we have only one fully accurate tool: the randomized, double-blind, placebo-controlled clinical trial. According to Dr. Boozer, five of her 167 study subjects developed high blood pressure (and were therefore dropped from the six-month-long study). Three were in the placebo group and two in the experimental (ephedra) group.

Inspector General's recommendation is irrelevant to solving problem

The MSNBC story concludes with three recommendations from the report from the inspector general of the Department of Health and Human Services. One of those recommendations is that "ingredients in supplements should be standardized to guard against contamination."

However, standardization is irrelevant to the issue of contamination, as any herbalist can tell you. Contamination is caused by poor manufacturing practices -- things like incomplete cleaning of machines and not testing raw materials. The FDA will soon be issuing a final regulation on good manufacturing practice (GMP) standards that all supplement manufacturers will be required to meet; the National Nutritional Foods Association (NNFA) already has a GMP inspection and certification program in place, complete with a seal that companies can place on their labels.

Also, Roy Upton of the American Herbal Pharmacopoeia points out that dietary supplements are already required to be both safe and pure (free of pathogenic contaminants) under the FDA's current GMP standards for foods. The FDA's new GMP standards for dietary supplements will be more stringent than those for foods largely because the procedures for processing supplements are more complex and in some ways more technically challenging than those for foods.end-of-story

 

 

 

   
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