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
Stephen 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, Georgetown 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 David 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. Hilary
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, Robert 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 James
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-Davis, 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, Robert 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 David 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]."
