Report On Supplements Is Biased And Factually Inaccurate
Wyn Snow, Managing Editor
MSNBC news story entitled "Unsafe supplements?" authored
by NBC News correspondent Robert Hager that appeared on MSNBC.com
on April 10th is overflowing with questionable points, some of them
factually inaccurate, and is therefore misleading. Detailed commentary
on specific points follows below.
claims public health is endangered -- but FDA has authority to act
overall thrust and conclusion of the MSNBC story is that public
health is being endangered by "lack of industry oversight" and that
more regulation is needed. Yet the FDA does have the authority to
remove dangerous products from the marketplace. For example, the
FDA has tried on several occasions to prove that ephedra is dangerous
and should be removed from the market, yet has not succeeded in
proving its case. Indeed, at least one senior official within the
FDA has testified before Congress that the agency has sufficient
authority to act, if such action is warranted.
150 million Americans taking supplements, I suggest their interests
are better served by calls for increased funding of research so
that supplement use is based on science rather than anecdotal evidence
bandied about by both pro- and anti-supplement points of view. In
this respect the MSNBC article seems more like the representation
of a third-party point of view than carefully researched reportage.
dangers of supplements and pharmaceutical drugs
writing about the supposed dangers of supplements -- whose safety
record remains to be seriously challenged -- the media ignores the
real pink elephant in the middle of the room. The pharmaceutical
industry is highly regulated and has plenty of government oversight.
Companies are required to have absolute proof of efficacy and absolute
proof of safety before a product can be brought to market, through
research that costs upwards of $250 million per product. Yet despite
such "absolute proof of safety and efficacy," approximately 100,000
Americans die each year from properly prescribed pharmaceutical
understand that allopathic medicine and pharmaceutical research
have revolutionized trauma and clinical care in our time. I also
understand that errors and unforeseen consequences are side effects
of a medical practice serving the entire nation. But I am compelled
to note that if the vast majority of American adults are consuming
supplements (see Kaiser Family Foundation data), then elementary
logic infers that our government, our universities, and news organizations
such as MSNBC should recognize the opportunities as well as the
risks contained in this fact.
potential for gains in personal health and wellness, in quality
of life and economic productivity are contained in enhanced nutrition
and supplementation? What are the implications of a healthier America
for an economic environment in which medical costs are cannibalizing
an ever-growing portion of the total economy? What benefits might
accrue from stimulating use of scientifically proven supplementation
regimens among consumers who are apparently already convinced that
supplements are beneficial?
issue is social values reflected in allocation of research funding
real issue is not one of regulation or stirring up fear and anxiety
in the public arena. Consider: What social values are reflected
in an NIH budget that allocates to supplements substantially less
than 1% of the amount expended annually for medical and health research?
not informed of adverse reactions -- by state poison control centers
story said, "The government doesn't hear about the vast majority
of health problems associated with dietary supplements, according
to an unpublished report from the inspector general of the Department
of Health and Human Services."
Inspector General's report demonstrates that government's right
hand isn't talking to government's left hand -- in particular
that state Poison Control Centers aren't communicating with the
federal Food and Drug Administration.
though the story merely reports on and quotes the Inspector General's
report, it neglects to point out that communication channels can
easily be established through administrative procedures -- and
thereby provide whatever information is appropriate to protecting
public health. Such administrative procedures would be easy to
establish even in states where poison control centers are private
rather than public.
unable to determine ingredients in products -- but ingredients must
be listed on product label
MSNBC story states that the FDA "was unable to determine the ingredients
in 32 percent of the products mentioned in adverse event reports."
they read the label? According to the FDA's own regulation, as
of March 23, 1999 dietary supplement products must include an
information panel titled
"Supplement Facts"; all ingredients in the product must be declared
in the ingredient statement or within the "Supplement Facts" panel.
fact, "Supplements have been required to state their ingredients
for decades," according to Roy Upton, Executive Director
of the American Herbal Pharmacopoeia. "Supplements have always
been regulated as foods, which are required to list ingredients
in descending order of predominance." The Dietary Supplement
Health and Education Act (DSHEA) of 1994 established dietary supplements
as a new category distinct from both foods and drugs.
control centers receive 13,000 reports of reactions to supplements
MSNBC story says "in a recent year when the FDA received 470 reports
of bad reactions to dietary supplements, the nation's poison control
clinics actually treated 13,000."
accurate are these 13,000 case reports? The
poison control center in Massachusetts states that of the 24 poison-related
deaths in 1997, "citation of a drug or chemical does not
necessarily imply that these agents were the cause of death."
This statement suggests that reports to poison control centers
may be just as anecdotal, unverified, and vulnerable to errors
FDA adverse event reports, which
are also vulnerable to fraud because they are anonymous.
even if these 13,000 reports of adverse reactions are indeed accurate,
this represents less than one-hundreth of one percent of the 150
million Americans taking supplements, or approximately one person
out of 11,536 -- which can reasonably be interpreted as evidence
of an excellent safety record of supplements.
experts characterize botanical supplements as having dangerous side
the MSNBC story, anonymous experts say that "ephedra may cause blood
pressure problems and strokes, ginkgo biloba can lead to excessive
bleeding, while St. John's wort may block the effectiveness of anti-viral
are these experts? It is not surprising that botanical products
have side effects. So do all OTC drugs, including aspirin. Indeed,
some of these so-called side effects can be beneficial.
to Roy Upton of the American Herbal Pharmacopoeia, "The fact
that ginkgo thins the blood may justify its use in preventing
stroke (as aspirin is used), but in addition (unlike aspirin)
perhaps memory will be enhanced and it will provide antioxidant
benefits. With St. John's wort enhancing cytochrome P-450 activity,
this may mean it can be used to enhance the body's detoxification
of potentially toxic drugs, and that the dosage can simply be
increased accordingly when used with other medications."
and side effects of this kind are what label warnings, pharmacopoeias
and desk references are for. There are many references accessible
to consumers for a universe of supplement products. And appropriate
warnings, as previously noted, can be as close as the label on
disagree about dangers of ephedra
MSNBC story states "Research on ephedra that was commissioned by
the FDA concluded that the supplement poses risks that far outweigh
any benefits it might have. Results were published last November
in The New England Journal of Medicine."
NEJM article (published in December, not November) was not new
research; instead it analyzed the unreliable and unverified anecdotal
reports collected by the FDA. This is not unbiased research, nor
do all experts agree with the NEJM article's conclusions.
to Grover M. Hutchins, MD (an anatomical pathologist and paid
consultant to the Ephedra Education Council), his analysis of
22 reports from the same FDA data in which death occurred indicates
that these data "showed no consistent clinical or pathological
features of the reported adverse events and showed that ephedrine-type
alkaloids were not likely to have been causative or contributing
factors in the deaths. ... With an adequate explanation of the
reported adverse events, the implication of ephedrine-type alkaloids
in deaths from a wide variety of conditions that occur in the
general population is no more than idle speculation." (Source
published in the NEJM; the NEJM study's authors then rebut Hutchins'
rebuttal; the two letters make interesting reading about the medical
meaning of the term "cause of death.")
for Science in the Public Interest makes erroneous claim
the MSNBC story, Bruce Silverglade (of the Center for Science in
the Public Interest) says, "Right now consumers are playing a game
of Russian roulette because no one is sorting out products that
work from those that don't."
is factually untrue from two points of view: both efficacy research
number of supplement manufacturers do conduct efficacy research.
Also, two agencies in the federal Department of Health and Human
Services (DHHS) are cofunding efficacy research: the Office of
Dietary Supplements and the National Center for Complementary
and Alternative Medicine, formerly the Office for Alternative
Medicine. We reported on NCCAM
research last June. Also, the Office of Dietary Supplements
has created a database of research about dietary supplements --
IBIDS -- which now contains
more than 400,000 unique bibliographic records about dietary supplements
from 1986 to the present.
testing of products to determine "which work," ConsumerLab.com
compares products with formulations shown to be effective in clinical
trials, and several other organizations are developing third-party
testing and certification programs. We have described ConsumerLab's
work, NSF International's nascent certification
program, and keep a page that lists ConsumerLab's currently
placebo-controlled research characterized as "industry-financed"
MSNBC story also says that "While the FDA has received claims of
70 deaths among ephedra users, an industry-financed study turned
up no problems."
characterizing Dr. Carol Boozer's study as "industry-financed,"
the story implies that the FDA's reports are more accurate or
reliable. Instead, the FDA reports are anecdotal at best -- while
Boozer's study is an example of "the gold standard" of research:
a randomized, double-blind, placebo-controlled clinical trial.
This is exactly the kind of research that Bruce Silverglade, who
is quoted in the MSNBC article, says isn't being done. Also, virtually
all pharmaceutical research is "industry financed," yet no one
denigrates this research on those grounds.
several herbal companies contributed funding to Dr. Boozer's study,
the funding was indirect; the money went through Science Toxicology
and Technology, an independent consulting firm of physicians and
toxicologists based in San Francisco that funded her research.
This is not unlike charitable contributions being distributed
by United Way, or a consortium of herbal companies underwriting
the tasks and expenses of the Institute for Nutraceutical Advancement,
which develops rigorous testing methods for botanical products.
MSNBC story quotes Dr. Boozer accurately as saying, "The bottom
line is that in our studies we found that there were no real health
consequences, significant health consequences, to individuals that
were taking these products," and give her affiliation with the New
York Obesity Research Center.
the story neglects to mention that the New York Obesity Research
Center is further affiliated with Columbia Medical School, an
organization with some prestige and a solid reputation.
to the same NEJM article mentioned above, 12 million people took
ephedra in 1999. Dr. Boozer points out that whenever 12 million
people do the same thing (such as get haircuts, drink water, take
aspirin, or drive to work), some will get heart attacks, high
blood pressure, or strokes -- and some will die for reasons both
directly and indirectly associated with the activities in which
they are engaged.
we then conclude that haircuts, water, aspirin or driving to work
caused the heart attacks, high blood pressure, strokes and death?
No! To distinguish between coincidental and causative connections,
we have only one fully accurate tool: the randomized, double-blind,
placebo-controlled clinical trial. According to Dr. Boozer, five
of her 167 study subjects developed high blood pressure (and were
therefore dropped from the six-month-long study). Three were in
the placebo group and two in the experimental (ephedra) group.
General's recommendation is irrelevant to solving problem
MSNBC story concludes with three recommendations from the report
from the inspector general of the Department of Health and Human
Services. One of those recommendations is that "ingredients in supplements
should be standardized to guard against contamination."
standardization is irrelevant to the issue of contamination, as
any herbalist can tell you. Contamination is caused by poor manufacturing
practices -- things like incomplete cleaning of machines and not
testing raw materials. The FDA will soon be issuing a final regulation
on good manufacturing practice (GMP) standards that all supplement
manufacturers will be required to meet; the National Nutritional
Foods Association (NNFA) already has a GMP
inspection and certification program in place, complete with
a seal that companies can place on their labels.
Roy Upton of the American Herbal Pharmacopoeia points out that
dietary supplements are already required to be both safe and pure
(free of pathogenic contaminants) under the FDA's current GMP
standards for foods. The FDA's new GMP standards for dietary supplements
will be more stringent than those for foods largely because the
procedures for processing supplements are more complex and in
some ways more technically challenging than those for foods.