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Editorials

Supplement Study In AMA Journal Shows Bias And Misunderstanding
12 August 2001
by Wyn Snow, Managing Editor

I. INTRODUCTION

A recently published article in the Archives of Internal Medicine (AoIM) suggests that consumers in the US are of mixed opinion regarding the use and benefits of dietary supplements. Entitled "Americans' Views on the Use and Regulation of Dietary Supplements," the article appeared in the 26 March 2001 issue. AoIM is published by the American Medical Association, the leading professional society for physicians in the US.

The article uses survey data developed in association with the Kaiser Family Foundation and National Public Radio to show consumers are confused about the current regulatory status of supplements. Based on their findings, the article states consumers seek heightened government regulation as a means to increased purity and safety for newly introduced supplements.

Of particular concern to the authors, who in the main are associated with the Harvard School of Public Health and Harvard's Kennedy School of Government, is the potential for medical complications when consumers, for whatever reason, do not reveal their use of supplements to physicians while being treated for a variety of medical conditions.

Misunderstanding of supplement regulation

We believe a number of suppositions made by the authors based on survey findings show a troubling misunderstanding of supplement regulation. Among those who crafted and analyzed the two opinion surveys appearing in the article there appears to be a lack of knowledge of supplements and their use. Given the presence of these misperceptions in the article and the fact that AoIM is peer reviewed, one can assume the authors' bias and lack of knowledge is shared by those who reviewed the article prior to publication.

"The authors don't have a clue about the FDA's role in regulating supplements."
-- Dr. Shari Lieberman (see full text of her comments)

 

Just as troubling is the presence of the article in an American Medical Association-sponsored publication. Given the historic rejection by physicians of botanicals and supplements for preventative and therapeutic purposes, it would seem any article published under the imprimatur of the American Medical Association (AMA) should observe the most rigorous technique, taking special care to guard against negative predisposition and structural bias.

This is particularly so given the almost total lack of training in nutrition and supplementation techniques in American medical schools on one hand and a virtual stampede on the part of consumers to the use of supplements, on the other.

Overall bias of perspective

While there were some minor glitches in data reporting (see sidebar describing inaccuracies in data reporting), the article as a whole shows a more subtle kind of bias. Questions were framed and presented from a perspective that views vitamins and minerals as fundamentally different from other kinds of dietary supplements. This bias led to survey responses that cannot be relied upon as accurate information describing the opinions of adult Americans concerning all dietary supplements.

We do not believe this was done with an intent to mislead. The difficulty lies in the way survey questions were designed and administered. Author bias, always a concern, was clearly evident in this case. As scientists and healers, doctors need to understand a wide range of points of view, regardless of whether they agree with those views or not.

Less ambiguous is the need to rationalize the current state and federal regulatory framework surrounding supplements. Physicians in particular are especially aware of supplement risks. People experiencing side effects and adverse interactions resulting from inappropriate supplement use show up in their offices, clinics, and hospitals.

Doctors are less likely to see supplement success stories unless a patient explicitly says, "This supplement is really working for me!" Also, bogus advertisements touting supplements for weight loss, muscle gain, hair regrowth, and breast enhancement -- all of which sound too good to be true and all using products described as natural -- bombard the public from radio stations and TV infomercials.

More stringent regulation seen as an easy fix

In such an environment, it is easy to gain the impression that most non-nutrient supplements are modern versions of snake oil. Equally easy is the temptation to solve the problem of specious and misleading advertising claims with the easy fix of more stringent regulation. But regulatory regimes are fraught with complexity and unforeseen consequences. We believe calls for further supplement regulation are in fact a misguided effort to achieve laudable goals through inappropriate methodology. When considered in their various aspects, such concerns as doctor-patient communication, undocumented or unrealistic benefit claims, toxic reactions and others are all susceptible to rational solutions -- such as continuing education, databases, and Quackwatch programs.

In practice, such an approach requires planning and education as well as the active enforcement of current law. But with the cooperation of supplement manufacturers, medical practitioners and support from Congress for funding enforcement of laws already on the books (such as the Dietary Supplement Health and Education Act), the scenario laid out by the authors of "Americans' Views on the Use and Regulation of Dietary Supplements" can be put into its proper perspective. In practice, we believe the development of quality standards, a trend with increasing support among makers and users of supplements, holds great promise for supplement consumers and health practitioners alike.

"The FDA doesn't need more power to regulate, they need to focus on what they're supposed to do."
-- Dr. Shari Lieberman (see full text of her comments)

 

II. ABOUT THE SURVEYS

A critique of the two surveys follows, accompanied by a description of the potential consequences of more stringent regulation as opposed to the benefits of the alternative solution of enhanced quality standards.

Inaccurate use of the term dietary supplement

The opinion surveys in "Americans' Views on the Use and Regulation of Dietary Supplements" used the term dietary supplement in a way that is not wholly accurate. This has serious implications both for the results of the surveys and for conclusions based on those results.

The authors of the article say almost half (48%) of American adults take "some type of nonprescription vitamin, dietary, or mineral supplement regularly." However, only one in six (16%-18%) regularly use "dietary supplements, like echinacea, ginseng, amino acids, or over-the-counter hormones." Similarly, the two surveys at the center of the article's main argument defined regular users as people who "regularly use products, such as echinacea, ginseng, over-the-counter hormones, or amino acids."

By excluding vitamins and minerals from their definition of dietary supplements, the surveys removed almost one-third (30%) of their respondents from the category of regular user. In all likelihood, this definition created a bias in the respondents' minds, which in turn may well have affected the results and invalidated either some or all of the researchers' conclusions.

Impact on survey results

The survey's regular users of vitamins and/or minerals may well have responded differently if these nutrients had been included in the definition of supplement. Respondents are especially likely to have given different answers to the questions "How important is access to supplements?" and "Are supplements good for health and well-being?" The percentages of regular users, sometimes users and nonusers who answered "yes" undoubtedly would have been quite different.

By asking the question about supplement use in this way, the surveys also establish a meaning to the term supplement that is inaccurate insofar as legal and regulatory definitions are concerned. As a result, opinions expressed about "supplements" are not relevant to the current regulatory environment. This is like asking people about apples and then applying these opinions to discussions about oranges.

A better design would be to ask respondents which supplements they use and how often. Data from such a survey can be analyzed in a wider context and would produce more accurate and relevant results.

Another means of generating more accurate information would have been to ask each question again for each kind of supplement: vitamins/minerals/nutrients, botanicals, sports nutrition, and so on. Americans may believe that some kinds of supplements are more adequately tested, less likely to cause harm, more truthfully advertised, and less in need of increased regulation than other types.

Supplements called "mostly untested and unregulated products"

The authors of the article consistently characterize supplements as "mostly untested and unregulated products" -- which is untrue on both counts.

All supplements are regulated under the provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA), which established supplements as a category distinct from drugs (both prescription and over-the-counter), and also distinct from both foods and food additives.

DSHEA was passed to protect supplements from the opinion of the federal Food and Drug Administration (FDA) that supplements are essentially drugs and should undergo extensive pre-market testing to prove their absolute safety and absolute efficacy before they can be marketed. Prior to the passage of DSHEA, the FDA was raiding the offices of doctors and supplement manufacturers and seizing supplements that they claimed to be "mislabeled drugs."

The effect of such action, especially in the face of sensational media coverage, was to create a high level of anxiety among users of supplements. Members of the medical community were subjected to federal charges and otherwise held up to ridicule. Notably, dietary supplements and those who make and use them were cast in a negative light. In the midst of much pontificating of the "doctor knows best" variety, the age-old use of supplements (botanicals) and more recent use of vitamins and minerals in concentrated form came under sharp attack. This context informed the thinking that resulted in passage of DSHEA.

About supplement regulation

In contrast to the pre-market regulatory environment used for drugs and some food additives, DSHEA established a post-market framework for supplements. Supplement companies are still required to have evidence that their products are both safe and effective for the purposes claimed in their marketing claims and literature. However, they are not required to present this evidence to the FDA and gain the FDA's permission before placing products on the market. Instead, the FDA has full authority to remove unsafe products from the market. The FDA has stated in Congressional hearings that in fact they have enough authority to do so. Companies are also required to be truthful in their advertising, and the Federal Trade Commission (FTC) has full authority to stop companies from making false claims.

In a pamphlet for patients about herbs and anesthesia, the American Society of Anesthesiologists states, "The government regulates herbal medicines in the same way that it regulates food and nutritional supplements, but herbal products do not undergo the same strict research requirements as prescription drugs or over-the-counter medications (like aspirin)."

The authors of the article may believe that supplements are inadequately regulated (which is a valid political opinion), but stating that supplements are unregulated gives inaccurate and misleading information to their colleagues and the public.

About supplement testing

Concerning testing, according to the PubMed database maintained by the National Library of Medicine, more than one million research studies have been performed concerning the sixty-nine most popular supplements (see sidebar tabulating citations of published research). Almost half of this research was conducted on minerals; another third was conducted on vitamins and amino acids. Even though botanicals and substances like shark cartilage are much less extensively researched than these nutrients, the ten botanicals listed in a sidebar accompanying this article appear in 9,707 articles in the PubMed database. Even many controversial supplements have received substantial scientific attention: creatine showed 29,355 studies; glucosamine 13,281; melatonin 8,803; DHEA 6,850.

The authors of the article may believe that these studies are flawed in various ways or that more research is needed, but to call these supplements untested again gives inaccurate and misleading information to medical practitioners and their patients. There are vastly more research studies on most supplements than the number typically conducted to get FDA approval of a new drug!

Survey called for simplistic answers

Questions on the survey asked for simplistic yes/no answers -- which does not allow for more complex and realistic responses.

On the question "Are supplements good for health and well-being?", 173 people volunteered "some are, some are not," which was not among the official answers but happens to be the most accurate one. On this question, 52% of all respondents said "yes", 17% said "no", another 17% said "some are, some are not", and 14% said they don't know.

Two more questions where the most accurate answer is "some are, some are not" were: "Are supplements adequately tested?" and "Advertising for supplements is not true, or generally true?"

Responses to "How often are people harmed by supplements?" were grouped into "often or sometimes", "rarely or never", and "do not know". The terms often and sometimes are both vague terms that mean quite different things to different people. Even the term rarely can reflect a range of meanings. More to the point, the survey might have asked respondents to estimate or guess how many people are harmed by supplements in the course of a year.

Supplement users said to ignore scientific evidence

One result that clearly surprised (and possibly alarmed) the authors of the article is that two-thirds (66%) of supplement users would continue to use "the supplement they use most often" even if the FDA said the supplement is not effective. The researchers characterize this result as "regular users believe strongly in the usefulness of various dietary supplements irrespective of the scientific evidence."

"Authors used the term belief as if there were no research demonstrating the benefits of supplements. In fact, there are hundreds, sometimes thousands of studies . . ."
-- Dr. Shari Lieberman (see full text of her comments)

 

First, we note the obvious in pointing out that "scientific evidence" and "FDA says" are not the same thing. The FDA takes a very conservative view of how much scientific evidence is enough to prove efficacy; supplement users are more likely than nonusers to be aware of this conservative stance. While this conservatism is appropriate for a government agency (we wouldn't want the FDA to jump on and off the bandwagon with every "bleeding edge" research report), individual citizens are freer to draw their own conclusions.

Next, we would suggest a different interpretation -- that people who experience positive results from supplement use are most interested in a particular kind of scientific evidence: the case study. They have asked, "Does this supplement work for me (and/or family members and close personal friends)?" And for the supplement(s) they use most often, these people appear to have gotten an answer that satisfies them: Yes, it works for me.

Indeed, doctors are aware that people vary significantly in their body chemistry, enough to respond differently to various drugs, supplements and other treatments. Thus, doctors are vitally interested in a similar case study: "Does the treatment I prescribed work for my patient?"

Physicians are unlikely to ask this question about supplements because the curricula of most American medical and public health schools offer little or no training in supplementation. Indeed, subsequent to the Flexner reform of American medical education prior to World War I, American medical education with a few notable exceptions has focused exclusively on the allopathic medical model and divorced itself entirely from non-European, non-Western academic medical training.

We do not challenge the manifold benefits of modern medicine. However, given the extreme reliance of American medical training on the German model that Flexner relied upon so closely, future authors of studies like "Americans' Views on the Use and Regulation of Dietary Supplements," might consider including other healing protocols and perspectives in their surveys.

The question of what constitutes rigorous scientific evidence for European, Eastern and contemporary "alternative, complementary or integrative" medicine is certainly a valid subject for academic debate. However, it is unlikely that consumer preferences in supplementation are driven entirely by false advertising claims of charlatans or "fountain of youth cure-alls" in popular magazines. Perhaps the authors of the study in question might more profitably explore the sources of opinion that led Americans to spend over $16 billion dollars in 2000 on supplementation.

Confusion about government regulation

In a section devoted to regulation, the authors of the article say many Americans are "confused" about the government's regulatory role in supplements -- and state that 53% are "aware that supplements are not regulated." However, the authors are themselves among this 53% who mistakenly believe that supplements are not regulated! This finding strongly suggests a need for better education of the public and of medical professionals about existing supplement regulation.

The second question in this section -- "Allow new dietary supplements to be sold only if they have been tested by the FDA" -- says nothing about undesirable consequences that would result from requiring supplements to undergo pre-market screening. Consider another survey question: "How much more money would you be willing to pay for supplements so they can be tested by the FDA?" with possible answers of nothing additional, twice as much, four times as much, and more. One could imagine responses running parallel to the 81% "favor", 14% "oppose", and 5% "do not know" reported for allowing new supplements to be sold only after gaining FDA approval.

Another minor aspect of regulation not mentioned in this question is that the FDA does not do any testing itself. It reviews research performed by private companies, and licenses private laboratories to conduct testing.

The third question -- "Remove dietary supplements from the market if the FDA shows that they are unsafe" -- is a moot point for any discussion of regulation. Under DSHEA, the FDA already has this authority.

Ensuring safety, purity, and truth in advertising

This section of the article resembles jokes about "When did you stop beating your wife?" Of course Americans want to make sure supplements are not harmful. Of course Americans want to make sure supplements are pure and doses are consistent. Of course Americans want to make sure advertising claims are true. A better question is: Can more stringent regulation achieve these goals -- or is there a better and more cost effective way to achieve these ends?

Consider the consequences of requiring new supplements to go through the same kind of FDA approval process that is required for drugs before they can be marketed:

1. The cost of researching new supplements would skyrocket, innovation would come to a crashing halt, and prices of new supplements would be exorbitant.

Drugs are required to show both absolute proof of safety and absolute proof of efficacy, a process that takes hundreds of millions of dollars and years of research for each new drug that is approved. If new supplements are held to these same standards, the cost of development would be similar to that of a new drug. The FDA has written extensive guidelines for approving botanical supplements as drugs (only drugs are allowed to use health claims in their marketing). These guidelines use essentially the same criteria as those for pharmaceutical drugs. The authors of the article suggest that new supplements should also be held to the same criteria as pharmaceuticals.

Makers of pharmaceuticals are able to recoup the costs of drug research because their products are unique, often synthetic substances that can be patented. However, most supplements are derived from plants, animals, and other natural products in ways that cannot be patented, making it difficult if not impossible to support the expenses of pharmaceutical-scale research.

Also, requiring absolute proof of both safety and efficacy is appropriate for drugs, where the toxic dose is usually quite close to the therapeutic dose and where side effects are common and often dangerous. One wants to be very sure a dangerous substance is effective before using it to treat patients.

However, supplements generally have a much wider range of safe dosages, as well as fewer and less dangerous side effects. For this reason, the European medical community -- often held up as a regulatory model for Americans to follow -- also requires botanical products to have absolute proof of safety, but only relative proof of efficacy -- a standard that is easier for supplements to meet.

2. Sending every new supplement through an FDA pre-approval process would create a logjam of delay.

The FDA has stated that it does not have the financial resources to investigate all questionable supplements, which are a small fraction of the supplement market. Imagine these same sparse resources applied to reviewing all new supplement applications. The FDA already receives criticism for the delays involved in bringing promising new drugs to market -- an area with vastly greater funding than supplements. Useful supplements would sit in the pipeline for decades, gathering dust.

The current, post-market regulatory process is a more efficient use of the FDA's funds for supplements. It allows the FDA to focus its attention where it is needed most: on products whose safety or efficacy is questionable.

A post-market regulatory system does have its drawbacks. It is vulnerable to fraud and quackery in ways that a pre-market regulatory environment is not. However, the goals of safety, purity, and truth in advertising can be achieved in a post-market environment. Two elements are key: education and quality standards.

"Knowledge is the best prescription"

Dr. C. Everett Koop's often-quoted words that "knowledge is the best prescription" are as applicable to supplements as they are to other health concerns. When buyer beware is the watchword, consumers need to know how to choose wisely.

There are several simple actions that consumers can take to investigate product quality and protect themselves from the most blatant varieties of fraud. However, the biochemical complexities of supplements and their actions in the body generally mean that recommendations about supplements are most competently made by health professionals, rather than by vaguely worded structure/function claims on supplement labels or advice from health-food-store employees.

Indeed, Dr. Alan Gaby (MD), a teacher of medical nutrition at Bastyr University, says, "Patients want to get good advice from their doctors about supplements. Doctors who practice nutritional therapy will have patients lined up at the door wanting to see them."

Education of consumers and health care professionals is one important foundation of a robust post-market regulatory environment. Having solid quality standards is equally essential. Several organizations are currently developing a variety of quality-certification programs; by creating quality seals and other means of distinguishing product quality, these initiatives will make it easier to drive most kinds of shoddy products out of the marketplace.

III. DEEPER IMPLICATIONS OF REGULATION

The issue of supplement regulation could be debated from the comfort of plush armchairs except for the context in which it takes place: Americans pay a disproportionate price for health. Medical professionals, pharmaceutical producers and health insurance providers assure us that we are getting top value for our dollars -- but the question remains: Why are Americans paying such an expensive premium for health?

Economic considerations

Consider the price of computer chips in the open marketplace: Technological advances combined with plentiful supplies have caused prices to fall dramatically even as capacity and performance have risen just as dramatically. The technological complexities of making better computer chips are no less challenging than those of understanding the bioactivity of nutritional and botanical supplements. Could similar advances in improved medical care at reduced cost be achieved through the same kind of open-market-based regulatory framework? This is the basic premise of DSHEA: that such advances are possible.

Social and governmental implications

Indeed, a deeper question is what kind of society we want to have. American culture and government are founded on the concept of freedom. Our most precious documents establish the rights to govern ourselves, to speak freely, to worship as we choose, and a host of other rights under the umbrella of life, liberty and the pursuit of happiness. Are consumers not entitled under this same umbrella to pursue a variety of options for health and wellness? Is it possible that a marketplace driven by patient needs would develop better, more cost-effective alternatives?

Our freedoms are restricted only insofar as it is necessary to protect public safety and establish appropriate rules of interaction. While the pharmaceutical regulatory structure is touted as necessary to protect public health, it also forms a gateway that places price floors under a specific class of commodity: pharmaceutical drugs. While we all benefit from the fact that these drugs are protected by patents, we also suffer from the exorbitant prices that result. Generic alternatives do not become available until a patent expires, although other patented drugs similar to the original often appear before the original patent expires, some of them more effective and at a lower price.

Underlying cultural premise

There is a fundamental philosophical difference between the provider-centered view that health is a product that patients buy from a health practitioner and the patient-centered view that health is a state of being that people achieve through their own actions. The provider-centered view is equivalent to saying, "It's okay if you buy a Chevy but not okay to go down to the auto parts store and get a carburetor and install it yourself; you might get it wrong and go too fast and wind up driving off a cliff."

Indeed, the global medical community has many views of what a "health parts store" consists of and what kinds of "carburetors" are available and appropriate. Surely Americans are entitled to benefit from the best knowledge available through a wide variety of resources, especially since this country is rapidly becoming a hegemony of minorities with medical traditions that are thousands of years old. Practitioners within these traditions are highly experienced in using the very botanical medicines that are regarded as so controversial by Western allopathic practitioners.

Ironically, Western medical practitioners used similar botanical medicines well into the 20th century and many of our "modern" pharmaceutical drugs are based on botanicals. At the same time, many of these same Western medical practitioners whisper to their patients, "By the way, you should probably take a multivitamin every day; I do."

Basic nature of medical care

The issue of how we approach supplement regulation goes to the core concept of what constitutes medical care. Medicine can be viewed as a nurturing and supportive process between practitioner and patient -- rather than an isolated collection of technological knowledge that a practitioner uses to "cure" a patient, much as a mechanic "fixes" an automobile.

The former, interactive view suggests four components to medical practice: healing trauma, curing infectious disease, alleviating chronic health conditions, and achieving wellness (as a positive state rather than an absence of negative states). The Western allopathic approach has done magnificently well in the first two: healing trauma and curing infectious disease, but performs poorly on the second two.

Sadly, Americans are saddled with chronic health problems, from heart disease and obesity to diabetes and cancer. Millions are plagued with alcoholism and drug addiction, allergies and asthma, arthritis, back pain, chronic fatigue syndrome, osteoporosis -- the list goes on and on. Many of these conditions do not respond well to Western allopathic approaches, while other traditions are more successful with chronic problems and basic wellness. This situation suggests why Americans are turning to alternative medical practices with such enthusiasm.

Public forum and debate concerning supplement regulation

Basically, in health care just as in shoes, one size does not fit all. Patients respond differently not only to a variety of drugs, but also to a variety of treatments and basic protocols. Any discussion of supplement regulation needs to take all these factors into account and address the most fundamental question of all: What are the most cost-effective methods of providing effective, appropriate healthcare that meets the needs of the widely diverse American population?

Developing good answers to this question means that all parties to this debate need to understand the actual regulatory framework. Fixing a problem requires that we understand its real nature and causes, not what we imagine those causes to be. Physicians would unanimously agree that diagnosis is the first step, and that successful treatment depends upon making sure the diagnosis is an accurate one. For articles about supplement regulation just as for heart disease and diabetes and cancer, there is simply no room for bias and misunderstanding.

Sources

American Society of Anesthesiologists. "What You Should Know About Herbal Use and Anesthesia." Park Ridge IL, American Society of Anesthesiologists, 1999.

Robert J. Blendon ScD, Catherine M. DesRoches DrPH, John M. Benson MS, Mollyann Brodie PhD, Drew E. Altman PhD. "Americans' Views on the Use and Regulation of Dietary Supplements." Archives of Internal Medicine, Vol 161, No 6, 26 March 2001, pages 805-810.

Food and Drug Administration. Guidance for Industry: Botanical Drug Products (Draft Guidance). Center for Drug Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services, August 2000.end-of-story

 

 

 

   
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