Quack Watch 2 by munificent Blog entry

Blog: Quantum Intelligensia
by munificent

Quack Watch 2

Well apparently CAM alt med's had a favorable report, and quack watch took offense..And I noticed conflict of interests were sited in many instances- well, it's nice to know both CAM and traditional medicine can share in the same charges..and then the bit about the natural supplement act weakening the FDA (Is this bad?)

Date: 8/14/2005 4:09:56 PM ( 19 y ) ... viewed 1739 times

Institute of Medicine Committee
Issues Irresponsible "CAM" Report
Stephen Barrett, M.D.
The Institute of Medicine (IOM) has published a 350-page report [1] assembled by a committee dominated by advocates of "complementary and alternative medicine." The committee—which I refer to below as the "CAM Committee"—recommends amending the 1994 Dietary Supplement Health and Education Act to enable greater public protection against misleading claims made for dietary supplements, but nearly all of its other recommendations are poorly reasoned. Neither the IOM nor the parent organization, the National Academy of Sciences, has endorsed the report.

The National Center for Complementary and Alternative Medicine (NCCAM), which provided funding for the report, limited who could be on the "CAM" Committee by barring all persons whom the project administrators perceived as critics of irrational “CAM” practices. These critics, including me, were also excluded from presenting meaningful testimony to the "CAM" Committee or participating in prepublication review of the report. Yet neither NCCAM nor IOM cared one bit that many of the "CAM" committee members have economic and/or occupational conflicts of interest or strong commitments to irrational "CAM" ideology [2]. Some have also served on an NCCAM council or received an NCCAM research grant.

Like the White House Commission on Complementary and Alternative Medicine Policy [3], the "CAM" Committee fails to specify what methods it is talking about and fails to note that "CAM" is a marketing term rather than a definable set of methods. Its report states that CAM practices are widespread and increasing in use, but some of the data it cites are misleading. The report begins by stating that "total visits to CAM providers each year now exceeding those to primary-care physicians" and that "annual out-of pocket costs for CAM that are estimated to exceed $27 billion." These figures were published in a 1993 report by David Eisenberg, M.D. and are unfounded. Contrary to these estimates, Eisenberg inflated his results by misrepresenting established methods as "unconventional." [4] That survey and other surveys actually show that only about 10% of the population visit an “alternative” practitioner in one year, and that fewer than 1% visit acupuncturists, homeopaths, or naturopaths. Most visits are to chiropractors, many of whom treat patients far more often than is needed. During the past ten years, the use of dietary supplements and herbs has increased, but most of that increase has been due to the 1994 Dietary Supplement Health and Education Act (DSHEA), which weakened FDA regulation and relaxed rules against false advertising [5].

The "CAM" Committee report makes sweeping generalizations and attempts to set an agenda for widespread adoption of "CAM" research and teaching. Neither is justified. Despite spending more than $500 million over more than a decade on such research, the NCCAM has not produced one study that validates any “CAM” practice as safe or meaningfully effective for treating any illness or condition [6]. Nor is there any reason to believe that the teaching envisioned by the committee will provide science-based information to its recipients.

One-Sided Statements
The CAM Committee report contains many other statements that display its bias. Here are some examples, each of which is followed by my bracketed comments.

"Decisions about the use of specific CAM therapies should primarily depend on whether they have been shown to be safe and effective. But this is easier said than done, as there are extremes of belief about what counts as evidence. For some individuals, evidence limited to their own experience or knowledge is all that is necessary as proof that a CAM therapy is successful; for others, no amount of evidence is sufficient. This report will please neither of those extremes." [This statement insinuates that that people who criticize"CAM" practices or claims are closed-minded extremists. This is a "straw man" propaganda tactic. I would be very surprised if anyone on the "CAM" Committee could name a single person who fits its description of a closed-minded critic or provide a single good example of a safe and effective treatment that has been excluded from standard care because of ideological preference.]

"There are unproven ideas of all kinds, stemming from CAM and conventional medicine alike, and the committee believes that the same principles and standards of evidence should apply regardless of a treatment's origin. Study results may then move useful therapies from unproven ideas into evidence-based practice." [This statement falsely implies that "CAM" methods are sufficiently promising that our society should greatly increase the resources it focuses on these methods. I do not believe that is true. This statement also implies that "CAM" methods and scientific methods are equally promising. It also implies that not enough research has been done. On the contrary, there have been hundreds of trials and many systematic reviews of acupuncture and homeopathy, far more than needed to determine whether or not they are useful. There is wide agreement among specialists in bioethics, research design, and regulatory affairs about what constitutes evidence, how to gather it, and how to evaluate it. The fanciful notion about "extremists" is raised because scientific and ethical guidelines significantly impede the "CAM" agenda, which is for all intents and purposes, allergic to regulation and oversight.]

"A therapy should not be excluded from consideration because it does not meet anyone particular criterion—say, biological plausibility." [This statement refers to research funding. The "CAM" Committee lists nine factors to consider when deciding which research proposals should receive priority. The list includes biological plausibility, potential for benefit, and preliminary supporting evidence. This list, however, does not include whether or not previous research is promising or consistently negative. I believe that biological implausibility plus lack of evidence of efficacy should be enough to bar government funding of studies for the purpose of establishing effectiveness. The NCCAM has funded many studies of methods that had neither a plausible rationale nor supporting evidence. Despite using the listed criteria for over ten years, the NCCAM has yet to conclude that any "CAM" method should either be be adopted or abandoned. Moreover, I don't know of any instance where a research outcome caused an ineffective "CAM" method to disappear. Why didn't the IOM's "CAM" Committee comment on these problems? And why didn't it identify any methods that, based on current knowledge, should be discarded?]

"Tools are also needed to aid conventional practitioners' decisionmaking about offering or recommending CAM, where patients might be referred, and what organizational structures are most appropriate for the delivery of integrated care. The committee believes that the overarching rubric for guiding the development of these tools should be the goal of providing comprehensive care that is safe, effective, interdisciplinary, and collaborative; is based on the best scientific evidence available; recognizes the importance of compassion and caring; and encourages patients to share in the choices of therapeutic options. [This falsely implies that a large numbers of "CAM" methods can be integrated. That makes as much sense as saying that astronomers should collaborate with astrologers. Note carefully that the IOM Committee doesn't say much about what methods should be integrated—and it says nothing about which ones should not. Why didn't the committee recommend steering patients away from irrational methods?]

"Studies show that patients frequently do not limit themselves to a single modality of care—they do not see CAM and conventional medicine as being mutually exclusive—and this pattern will probably continue and may even expand as evidence of therapies' effectiveness accumulates. Therefore it is important to understand how CAM and conventional medical treatments (and providers) interact with each other and to study models of how the two kinds of treatments can be provided in coordinated ways. In that spirit, there is an urgent need for health systems research that focuses on identifying the elements of these integrative-medicine models, their outcomes, and whether they are cost-effective when compared to conventional practice." [This statement implies that popularity (marketing success) is related to effectiveness. It's far more likely that use is related to misleading publicity. Note that the "CAM" Committee says little about what methods should be integrated—and it says nothing about which ones should not.]

Self-Serving Recommendations
The "CAM" Committee report contains recommendations in bold-faced type scattered throughout its Executive Summary. For ease of reading, I have distilled them into 13 items to which I respond:

The same principles and standards of evidence of treatment effectiveness apply to all treatments, whether currently labeled as conventional medicine or CAM. The committee further states that implementing this recommendation requires that "investigators use and develop as necessary, common methods, measures, and standards for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies." [I disagree. Methods that could work only if the laws of chemistry and physics are rescinded should require extraordinary evidence. These include homeopathy, therapeutic touch, electrodermal testing, and other approaches that postulate the existence of nonmaterial energies.]

The U.S. Congress and federal agencies should amend the Dietary Supplement Health and Education Act of 1994 and the current regulatory scheme for dietary supplements, with emphasis on strengthening quality control; labeling; enforcement against misleading claims; research into how consumers use supplements; incentives for privately funded research; and consumer protection against "all possible hazards." [I agree with this recommendation but would add that herbal products are not dietary supplements and should be regulated differently.]

The NIH and other public agencies provide the support necessary to develop and implement (a) a surveillance system that collects data on patterns of use of CAM and conventional medicine; (b) practice-based research networks; and (c) CAM research centers to facilitate the work of the networks by analyzing information from national surveys, identifying important questions, designing studies, coordinating data collection and analysis, and providing training in research and other areas. [I disagree. No such system should be set up before it is clear what "CAM" practices, if any, are worth studying and what practical use the data would have.]

The NIH and other public agencies should provide the support necessary to include CAM-relevant questions in federally funded health surveys such as the National Health Interview Survey, the Nurses health Study, and the Framingham Heart Study. [I am skeptical. Quite a bit is already known. More surveys would enable "CAM" proponents to create news events, but whether the data would serve any useful purpose is unclear. Moreover, the number of "CAM" claims is countless and keeps expanding as promoters dream up new ways to sell their wares.]

The NIH and other public agencies should provide the support necessary to assess the changes in prevalence, patterns, perceptions, and costs of therapy use (both CAM and conventional). [I disagree. As noted in the above paragraph, more survey data would enable "CAM" proponents to create news events, but whether the data would serve any useful purpose is unclear.]

The NIH and other public and private agencies sponsor research to compare outcomes and costs of combinations of CAM and conventional medical treatments and models that deliver such care. [I wonder what methods the "CAM" Committee thinks should be studied in this way. Combining effective and ineffective methods will raise costs without increasing effectiveness.]

The Secretary of the U.S. Department of Health and Human Services and the Secretary of the U.S. Department of Veterans Affairs should support research on "integrated care delivery," as well as the development of a research infrastructure within such organizations and clinical training programs to expand the number of providers able to work in integrated care. [This falsely implies that enough value already exists for our government to make large investments that support "CAM" practices.]

Health profession schools should incorporate sufficient information about CAM into the standard curriculum at the undergraduate, graduate, and postgraduate levels to enable licensed professionals to competently advise their patients about CAM. [This might be useful if the teachings were sure to be science-based and sufficiently critical. But surveys cited later in this report suggest that most "CAM" instruction in medical schools today promotes irrational methods. The "CAM" committee doesn't appear to have considered whether medical school curricula are already overcrowded with information that is more important than "CAM" information.]

Federal and state agencies, and private and corporate foundations, alone and in partnership, should create models in research training for CAM practitioners. [This recommendation falsely implies that "CAM" is fertile territory for effective methods that just need to be discovered. However, the more money that is wasted chasing "CAM" clouds, the less will be available for pursuing promising science-based methods. No cadre of researchers for “CAM” methods is needed. If "CAM" methods were truly promising, researchers would flock to studying them. Before creating more "research models," it would be appropriate to determine whether they would lead to anything useful. This also implies that many "CAM" practitioners and practices have a great deal to offer the scientific community if given a chance. I doubt that this is true. Many of them have sufficient bias that they cannot conduct responsible research. Moreover, training support should be based on qualifications and not whether of not someone is identified as a "CAM" practitioner.]

National professional organizations for all CAM disciplines should ensure the presence of training standards and develop practice guidelines. Health care professional licensing boards and accrediting and certifying agencies (for both CAM and conventional medicine) should set competency standards in the appropriate use of both conventional medicine and CAM therapies, consistent with practitioners' scope of practice and standards of referral across health professions. [What planet does the "CAM" committee live on? It is not possible to establish useful guidelines for useless practices. It is not possible to set competency standards for quack practices. It is ludicrous to think that pseudoscientific practitioners can create valid guidelines. Moreover, is very little evidence that "CAM" guidelines would have much effect on patient care. The only guidelines I know of are chiropractic. One set, which is relatively sensible, has some good points but fails to criticize nearly everything that chiropractors do wrong. Some insurance companies have found it useful in stopping payment for certain practices, but no effect on patient care has been demonstrated. Another set is delusion-based, has zero value for patients, and is being used to try to force insurance companies to pay for irrational treatment.]

A user-friendly authoritative Website on CAM modalities should be created. [This begs the question of who would operate such a site and whether a government or government-funded agency would be permitted to criticize quack "CAM" methods if it wished to do so. Despite two years of work and considerable funding, the "CAM" Committee report doesn't identify a single "CAM" practice that should be suspect. At present, Quackwatch provides lots of "user friendly authoritative" information on "CAM" modalities. Yet the IOM officials in charge of producing this report would not permit me to participate in a meaningful way in its preparation. Moreover, for more than 10 years, many federal agencies have (a)referred questioners to organizations that provide misinformation and (b) refused to recommend organizations that provide high-quality information on "CAM" topics.]

The National Institutes of Health and other public or private agencies should sponsor quantitative and qualitative research to examine (a) the social and cultural dimensions of illness experiences, health care-seeking processes and preferences, and practitioner-patient interactions; (b) how often patients and providers adhere to treatment instructions and guidelines; (c) the effects of CAM on wellness and disease-prevention; (d) how the American public accesses and evaluates information about CAM modalities; and (e) adverse events associated with CAM therapies and interactions between CAM and conventional treatments. [A good place to start would be to investigate the harm done by the widespread recommendations by chiropractors and naturopaths who oppose vaccination.]

The National Library of Medicine and other federal agencies should develop criteria to assess the quality and reliability of information about CAM. [Those criteria already exist. They are part of scientific methodology. Furthermore, the National Library of Medicine is not trustworthy. Its MEDLINE database includes least 30 journal that advocate bogus “CAM” claims but excludes the one journal that specializes in the scientific analysis of bogus claims.]

Brazen Conclusions
The Executive Summary of the "CAM" Committee report concludes:

We are in the midst of an exciting time of discovery, when evidence based approaches to health bring opportunities for incorporating the best from all sources of care, be they conventional medicine or CAM. Our challenge is to keep an open mind and to regard each treatment possibility with an appropriate degree of skepticism. Only then will we be able to ensure that we are making informed and reasoned decisions.

I disagree. We are in the Golden Age of Quackery. The big discoveries in recent years have been (a) how clinical trial methods can be misused and manipulated, (b) how whole populations can be tricked, (c) how research dollars can be wasted, and (d) how the medical scientific establishment can be corrupted by grant money. The "CAM" Committee has utterly failed in its mission. Instead of advocating the bedrock principle that priorities for human experimentation should be based on plausibility, it proposes to change the rules of science. Our society's real challenge is to support only promising approaches and become open to discarding irrational ones.

In response to the report, NCCAM's director (Stephen E. Strauss, M.D.) issued a news release that is even more brazen than the report itself. He stated:

The IOM report speaks to a set of principles that apply not only to CAM but to all research. This is an achievement that has now elevated the discussion of CAM beyond the advocacy and skepticism that has long hampered the evolution of CAM science. The conclusion that CAM research should be held to the same rigorous standards as conventional medicine will further the scientific investigation of this new field, increase its legitimacy as a research area, and ultimately improve the public health. . . .

It is particularly gratifying that the IOM findings and recommendations mirror the advice that NCCAM independently accrued over the past year in its extensive strategic planning process to formalize its research agenda for the years 2005-2009. Issues common both to NCCAM’s new plan and the IOM report include the resolution to ensure rigor in CAM studies, to increase the emphasis on health services research, and to consider the ethical, legal, and social implications of CAM research and integrated medicine. Drawing upon the added insights and knowledge that the IOM report provides, NCCAM and its sister research institutes and agencies will continue our efforts to establish the safety and efficacy of CAM practices while upholding the highest standards of science [7].

Gratifying? I can see why Dr. Strauss thinks that. If the "CAM" Committee report is implemented, the biggest financial recipient is likely to be his agency, which funded the report and helped ensure that its conclusions were precisely what he wanted.

Acknowledgement
Robert S. Baratz, MD, DDS, PhD; Timothy N. Gorski, MD; William M. London, EdD, MPH; Wallace I. Sampson, MD; and Elizabeth Woeckner contributed to this analysis.

References
Committee on the Use of Complementary and Alternative Medicine by the American Public. Complementary and Alternative Medicine (CAM) in the United States. Washington, DC: National Academies Press, 2005.
Barrett S. Some Notes on the Institute of Medicine's Panel on "Complementary and Alternative Medicine." Quackwatch, April 30, 2003.
Barrett S and others. Analysis of the reports of the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). Quackwatch, June 14, 2002.
Gorski TN. The Eisenberg data: Flawed and deceptive. Quackwatch, March 16, 2002.
Barrett S. How the Dietary Supplement Health and Education Act of 1994 weakened the FDA. Quackwatch, May 18, 2002.
Sampson WI. Why the National Center for Complementary and Alternative Medicine (NCCAM) should be defunded. Quackwatch, Dec 10, 2002.
Statement by Stephen E. Straus, M.D., Director of NCCAM, in response to Institute of Medicine Report on CAM Use in the United States. NIH press release, Jan 12, 2005.
The article was revised on January 13, 2005.