Alt Med and Nutritional Supplements In the Crosshairs

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Alt Med and Nutritional Supplements In the Crosshairs

The Institute of Medicine Releases New Report on Complementary and

Alternative Medicine

Reporting and Commentary By Barry Chowka

©2005 By Barry Chowka

1-18-5

If the Institute of Medicine (IOM) has its way, alternative therapies

will soon be subjected to more rigorous government regulation and

oversight. Complementary alternative medicine (CAM) and alternative

therapies will have to be proven to work according to allopathic

medical models. The result, of course, will be that they will be less

widely available, and they will be more expensive. The IOM also wants

the federal law exempting nutritional supplements from being treated

like prescription drugs to be changed so that, in the future,

vitamins and herbal supplements will have to be proven safe and

effective according to conventional criteria before they can be sold

to the public. Much like the situation now facing consumers in

Western Europe and Canada, supplements, especially in their current

high concentration or mega-dose form, will be severely restricted,

unavailable in many cases, and prohibitively expensive.

On January 12, the Institute of Medicine, part of the sprawling quasi-

government National Academy of Sciences (NAS), released a 300-plus

page report, Complementary and Alternative Medicine in the United

States, that advances and expands the ongoing mainstream critique of

alternative medicine. The IOM and NAS are the highest level and most

prestigious science and medical public policy think tanks that advise

the U.S. government. Their membership is made up of several thousand

conventional experts mostly drawn from academia. Annually, the NAS,

which was formed in the 1860s during the Civil War, issues over 350

book-length reports on a wide variety of subjects. [see note 1 below]

NAS and IOM reports are generally accorded the highest credibility by

the mainstream media and science and medical Establishments. Many of

the NAS and IOM reports are soon forgotten but some, touching on hot

button issues, are widely read and extremely influential as they

serve as the basis for changes in public policy and legislation in

the U.S. Congress.

Cause for extreme concern

Anyone interested in alternative medicine, in particular freedom of

medical choice without unnecessary government interference, should be

concerned about the IOM's Complementary and Alternative Medicine in

the United States.

The titles of the many mainstream news stories generated by the

report point to some disturbing implications, for example: " Popular

remedies need closer study, report urges " ; " Tougher rules urged for

dietary supplements " ; " Report Calls for Tougher Oversight of

Alternative Medicine. "

The IOM CAM report took two years to research and write, with the

process overseen by an elite panel of mostly conventional medical

authorities. A number of alt med " leaders " contributed to it. The IOM

report follows earlier, similar, years-long studies by other official

agencies, including the Office of Alternative Medicine (1995), the

White House Commission on Complementary and Alternative Medicine

Policy or WHCCAMP (2002), and the Office of Technology Assessment

(1990). All of these earlier efforts explored similar, if not quite

identical, themes. There have also been scores, if not hundreds or

even thousands, of similar studies and articles published in the

medical and scientific literature during the past 10-15 years. (On

January 14, a search of keywords " alternative medicine " at the

National Library of Medicine's PubMed returned over 96,000 abstracts

of studies published in the MEDLINE-indexed scientific literature.)

The IOM's 2005 CAM report apparently pleased E. Straus, M.D.,

director of the National Center for Complementary and Alternative

Medicine, the National Institutes of Health entity that originally

commissioned the IOM CAM study. According to a statement by Straus,

requiring the same research standards [for supplements and CAM

therapies that conventional therapies supposedly have to meet, as the

IOM recommends] " will further the scientific investigation of this

new field, increase its legitimacy as a research area and ultimately

improve public health. "

Targeting nutritional supplements

In its new CAM report, the IOM singled out dietary supplements as

culprits worthy of expanded federal regulation and control. (This

follows up on a 2004 IOM report [see below].) In the face of massive

evidence to the contrary, the 2005 IOM report expressed concern about

the quality of herbal and nutritional supplements, asserting ''there

is little product reliability. " The IOM recommended that Congress

take steps to require improved quality control of supplements and to

provide incentives to study the efficacy [emphasis added] of

supplements, as well. ''Reliable and standardized products are

needed, " Stuart Bondurant, M.D., Interim Executive Vice President and

Executive Dean, town University Medical Center and the chair of

the committee that prepared the IOM CAM report, said at a press

briefing on January 12. Bondurant also mentioned " evidence based

medicine " in his opening statement. (As noted in an article on

December 15, 2004, a new study by the Citizens' Council on Health

Care (CCHC) in Minnesota criticizes evidence based medicine.

According to CCHC report author Twila Brase, R.N., " Evidence-based

medicine [EBM] is an attack on the patient-doctor relationship. EBM

is not individualized care. It is group-think medicine. . .Control

over medical decisions is being shifted from doctors to data

crunchers; from professionals at the bedside to bureaucrats in big

offices. . .The public should not be fooled by the nifty-sounding

names. Evidence-based medicine is managed care masquerading as

science. " )

The only critical response to the IOM CAM report that could be found

online on January 14 was by Annette Dickinson, Ph.D., president of

the Council for Responsible Nutrition (CRN), a dietary supplement

industry trade association. She said in a statement: " The [iOM]

dietary supplement chapter is an unwarranted hatchet job. "

In fact, a powerful new campaign to marshall public and government

support for regulating alt med is being developed by anti-alt med

forces (or at least by players who are not sympathetic to primary

alternative medicine) with the complicity of many in the CAM

community itself. This effort entails the allegation that

supplements, especially herbs, have unknown synergistic effects when

taken with prescription drugs and that these " herb-drug interactions "

might possibly harm patients. Further, it is claimed that many if not

most of the scores of millions of Americans who regularly use

supplements and herbs do not tell their doctors what they are doing.

The solution, according to the IOM and others in sync with this way

of thinking (including, perhaps surprisingly, many licensed

naturopaths), is to make nutritional supplements and herbs

prescription-only, or at least government-approved, items.

The IOM CAM report also urges that the federal government require

that complementary and alternative medical therapies, including

herbal remedies and acupuncture, meet the same standards of

effectiveness as conventional medical treatments, before they are

allowed to be used clinically. This scenario is exactly opposite to

the way alt med has evolved and grown to this point.

In light of the widely reported failures of the Food and Drug

Administration (FDA), the leading government agency that oversees and

regulates conventional drugs and medical treatments, to do its job

(witness the recent recall of the prescription pain drug Vioxx,

alleged to have caused more than 100,000 deaths and serious injuries

despite being approved by the FDA) [see note 2 below], the

recommendations of the IOM CAM report seem ludicrous in the extreme.

Yet, incredibly, they are championed not only by conventional medical

experts but by many leaders in the alt med field (some of whom

contributed to the IOM CAM report).

Joe Pizzorno, N.D., one of the most visible proponents of

naturopathic medicine and widely acknowledged as one of the leaders

of alternative medicine, a founder and past president of Bastyr

University in Bothell, WA (which has received millions of dollars of

federal research grants), for example, commented at a March 26, 2001

WHCCAMP meeting in Washington, D.C. that nutritional supplement

companies should be taxed in order to give the FDA more power to

regulate the supplement industry.

Many licensed naturopaths in both the U.S. and Canada have recently

been contributing, wittingly or otherwise, to the effort by

conventional medicine to shift health care options away from low cost

self-care and personal freedom and responsibility on the part of the

patient-consumer (such as in choosing and obtaining nutritional and

herbal supplements) to the licensed health care professional. For a

discussion of this disturbing trend, see the 2003 article " Are

Naturopaths Targeting Health Food Stores? "

Coincidence or ...?

The issuance of the IOM CAM report at this time is not an isolated

event. Among other coordinated developments, there are efforts

underway in Congress, particularly among Democrats, to overturn the

1994 law (the Dietary Supplement Health Education Act or DSHEA) that

has continued to exempt nutritional supplements from being treated

like drugs.

As the Institute for Health Freedom reported in its January e-mail

newsletter, " The National Heart, Lung, and Blood Institute (NHLBI)

announced (on January 10!) that it will hold a conference January 13

and 14, 2005 to evaluate the risks of interactions between dietary

supplements and prescription blood-thinning medications. The NHLBI

notes that up to 52 percent of the population reports using dietary

supplements and that four million Americans use blood-thinning

medications. "

Another study by researchers at Harvard including Eisenberg,

M.D. (who was also a member of the IOM panel that wrote the CAM

report), supporting the IOM's recommendations, was also published on

January 12 in the journal Alternative Therapies in Health and

Medicine. According to an article in USA Today, that study " found

that about 35% of Americans have used some form of alternative

medicine. Dr. Tindle, lead author of that report, said such

widespread use shows the necessity of studying the safety, efficacy

and cost-effectiveness of these approaches. The biggest change was an

increase in use of herbal supplements over the five years, the study

said. Both the Harvard and IOM reports cited a failure of a majority

of consumers using supplements to tell their doctors. 'This is

especially critical as more becomes known about the adverse effects

associated with individual dietary supplements as well as their

interactions with prescription drugs,' said Harvard's Tindle. "

Alternative medicine is being blamed for its success. More people are

using alternative therapies, truly adverse reports of patient harm

are miniscule, but leaders of conventional medicine insist that alt

med needs to be regulated.

One study that purports to establish potential harm was published on

December 15, 2004 in the Journal of the American Medical Association

(JAMA). The study is " Heavy Metal Content of Ayurvedic Herbal

Medicine Products " and one of its authors is Eisenberg. The JAMA

study asserts that one in five Ayurvedic medical products sold in

Boston-area South Asian grocery stores contains a potentially harmful

level of lead, mercury or arsenic. According to an article published

by India New England on January 1, the study's lead author, B.

Saper, M.D., M.P.H., director of integrative medicine at the Boston

University School of Medicine, and his study co-authors " are calling

on U.S. Congress to reform regulations of Ayurvedic medicines so the

products are tested for safety. " Eisenberg, director of the Harvard

Medical School Division of Research and Education in Complementary

and Integrative Medical Therapies, is quoted as saying: " In order to

investigate the efficacy of commonly used dietary supplements -

including Ayurvedic remedies - we need to test high-quality

standardized products free of contaminants and dangerous toxins. This

study reminds us of the need for regulatory reform involving dietary

supplements used by the American public. " But the India New England

article noted, " Ayurvedic textbooks describe a therapeutic role for

heavy metals such as mercury and lead. 'It's possible that some of

these products, perhaps those with concentrations of metals that are

extremely high, may have had metals intentionally included,' [saper]

said. "

One wonders, too, if it was a coincidence that on the evening of

January 12, the same day the IOM CAM report was released, the lead

story on CBS TV's 60 Minutes (Wednesday) (a segment titled " A

Prescription for Death? " ) bashed Shortt, M.D., described as " a

physician on the cutting edge of alternative treatments. "

A looming deadline

In e-mail and Web alerts, Citizens for Health notes:

" FDA is reviewing portions of DSHEA, the Dietary Supplement Health

Education Act. The agency may propose new and overly burdensome

regulations that could restrict your access to new dietary

ingredients and dietary supplements that were not on the market prior

to 1994 when DSHEA was passed.

Recall that 2.5 million concerned consumers contacted Congress

between 1992 and 1994 to support DSHEA and assure access to their

supplements. In response to the overwhelming consumer support,

Congress passed DSHEA and deliberately created new and different

regulations for dietary supplements. Congress enacted DSHEA to stop

the FDA from treating dietary supplements like food additives or

drugs and to protect consumer's rights to purchase these products.

We need to make our voices heard once again!

The deadline is February 1, 2005. Send YOUR Letter [to the FDA] NOW. "

The IOM 2004 Report

On April 1, 2004, the Institute of Medicine released a 370-page

report titled Dietary Supplements: A Framework for Evaluating Safety.

Commissioned by the FDA, it was the result of three years' worth of

work by a list of experts in the field and, like the IOM's January

12, 2005 CAM report, it received extensive national media coverage

attention.

The 2004 IOM report, in plain English (according to the headline of

one press account), says the " FDA Can Pull Supplements Without

Proof. " Another story highlights the report's conclusions: 'The Food

and Drug Administration doesn't need direct evidence of human harm

before taking steps to curb sales of a dietary supplement. . .Data

from animals, test-tube studies, even similar products can

suffice. . .The report promises to bolster new FDA efforts to crack

down on risky supplements -- and challenges long-held assumptions

that the agency must prove an ingredient unsafe before pulling it off

the market. "

Among its many recommendations, the 2004 report calls on the Congress

to increase funding for the FDA to oversee the supplement industry,

including requiring manufacturers to report customers' side effects

to the FDA. To do that, manufacturers would have to establish toll-

free hot lines and publish the contact information on supplement

bottle labels.

Even more problematic and expensive for the industry would be a new

requirement that manufacturers would need to provide the FDA with all

information about a supplement before it is marketed. That data would

include animal studies, laboratory tests, and other scientific

information including data about products similar to the new

supplement.

The chairwoman of the committee that wrote the 2004 IOM report,

Barbara O. Schneeman, a professor of nutrition at the University of

California-, was quoted widely in the media in support of the

study and of the need for regulation. In a reverse of the usual

revolving door in which a top bureaucrat goes from a job in a federal

agency to one in a related industry, less than two weeks after the

2004 report was published, Schneeman was appointed to head the FDA's

Office of Nutritional Products, Labeling and Dietary Supplements. The

office is a component of the FDA's Center for Food Safety and Applied

Nutrition.

The Bigger Picture

The freedom of citizens and consumers in countries of the European

Union (EU) and the United Kingdom to buy and use nutritional

supplements is under siege and that may soon be the case in the

United States. According to the Alliance for Natural Health or ANH

(UK) and other consumer interest groups, " proposals for EU, US and

Codex regulation could destroy natural healthcare. "

In a presentation (downloadable in MS Word format) at the American

College for Advancement in Medicine (ACAM) Conference, in San Diego

last November, Verkerk Ph.D., the ANH's executive director,

said: " Many argue that the period between 2004-6 is likely to be the

most critical yet faced by the natural products industry with regard

to regulation. Regulation has the potential to more or less

emasculate the innovative sector of the natural products industry. "

According to a message on the Internet,

" In August 2005 everything in Europe is about to change due to the EU

Food Supplements Directive (FSD). Banned items will include natural

vitamins such as mixed tocopherols (natural vitamin E), carotenoids

and b-12 methylcobalamin, all forms of sulphur, boron, vanadium,

silicon and most trace elements, the most readily absorbed and safest

forms of calcium, magnesium, zinc, selenium, chromium and molybdenum.

It will severely limit the doses of vitamins and will remove all high-

dose products from the market. It will include future restrictions on

nutrients such as fatty acids, amino acids, enzymes, probiotics,

phytonutrients, etc. The directive will dramatically limit future

innovation in the supplements industry, and seriously impact retail

outlets, complementary practitioners and consumers who choose to take

responsibility for their own health and let food be their medicine. "

In light of the news detailed above and other developments,

alternative medicine as we know it is in serious jeopardy.

Increasingly, according to a harmonized chorus of conventional and

CAM mouthpieces, united by mutual self-interest, ego, and the search

for power and economic advantage, alt med is being presented as

dangerous, and people and policy makers are being warned that

alternative therapies, and especially nutritional and herbal

supplements, require major new study (on top of the thousands of

studies already being funded by the NCCAM) as well as drastic new

federal regulation, oversight, and control. People are being told, in

effect, that they are too stupid to take responsibility for their own

health and to make informed decisions without the aid of the federal

government or a licensed medical or health specialist ( " CAM " or

conventional). It seems safe to say at this point, Caveat emptor

or " alt med consumer beware. "

Notes

1. The National Academy of Sciences 2003 Annual Report to Congress

provides interesting insights into its work. In the health area, as

they conduct research and mobilize support for conventional

approaches to vaccinations, mass screening of the population, drugs

for HIV/AIDS, etc., the NAS and IOM show themselves to be the

ultimate politically correct arbiters of national science and medical

thinking.

2. On January 2, 2005, the Financial Times reported that

Graham, the FDA employee who blew the whistle on Vioxx (which

resulted in its being taken off the market by its manufacturer last

September), " has vowed to publish research [in the UK medical journal

The Lancet] that suggests up to 139,000 Americans have died or have

been seriously injured as a result of taking the drug [Vioxx]. "

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