- So, the U.S. Food and Drug Administration has decided
to protect the public by banning the sale of ephedra. Their splashy press
conference created the frenzied impression that the dietary supplement
is the cause of massive numbers of serious health problems, including strokes,
seizures, heart attacks and deaths. Consumers were advised to stop using
this product immediately. FDA Commissioner Mark B. McClellan pointedly
noted that the FDA has the evidence to prevail in a court of law, in case
any of those scofflaw ephedra supporters want to fight about it. And Dr
Sidney Wolfe, Director of the Public Citizen’s Health Research
Group, released an inexplicably vitriolic statement condemning the FDA
for not enacting the ban sooner.
-
- Yikes! How have so many Chinese survived 4000 years of
ephedra use? Is ephedra a poison?
-
- After careful investigation the answer seems to be, well,
no.
-
- The FDA commissioned a study by the respected and independent
RAND Corporation to investigate some of the effects of the ancient botanical,
which in the past was used annually by an estimated 13 million Americans,
in 3 billion doses, for asthma, weight loss, and athletic endurance. Millions
of taxpayer dollars later, RAND scientists were able to link ephedra adversely
with a heightened risk for insomnia, anxiety, hyperactivity, nausea and
heart palpitations. The higher the dose, the more likely the side effects.
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- Just like coffee.
-
- That's pretty much it. To an astonishing degree, the
FDA's own supporting documents provide evidence against ephedra that is
at best ambivalent, uncertain and weak. Maybe they thought no one would
read them. Incredibly, there is nothing in the major ephedra study completed
by the RAND Corporation (http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-bkg0003-ref-07-01-index.htm),
nothing in the FDA's own white paper (http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html)
or press release (http://www.hhs.gov/news/press/2003pres/20031230.html),
both of which were based on the RAND report, that actually steps over the
line and claims that ephedra causes the serious health consequences that
would warrant a retail death sentence.
-
- The RAND report notes that adverse health effects due
to ephedra are 'rare outcomes'; that the non-scientific anecdotal case
reports against ephedra are based on 'insufficient documentation'; that
the link between ephedra and serious health risk 'cannot be assumed or
proven'; and that the most likely health effects, ones they call 'sentinel
events', have '[no proven] cause and effect relationship'. They take a
small, cautious leap and say that if those sentinel events were proven
to have been caused by ephedra, the possible risk of serious health consequences
could be 1 in 1000 users, a safety margin that aspirin manufacturers might
envy.
-
- What about those 155 deaths that the news media alleged
repeatedly were caused by ephedra? The RAND scientists found a possible
two, about the same as I found with an internet search for deaths caused
by caffeine. The widely reported death of Baltimore Orioles pitching prospect
Steve Bechler, described again and again by the press as the result of
ephedra use, was actually caused by a heat stroke. You wouldn’t
know that, though, if you skipped the fine print.
-
- To their everlasting credit and with uncompromising clarity,
the RAND scientists refused to cave and give the FDA the justification
that it clearly sought to ban the sale of ephedra. Not that it mattered,
of course. The RAND report must have been déjà vu for the
FDA, because, according to their white paper, they were told essentially
the same thing in a report from the General Accounting Office in 1997.
That report temporarily derailed the FDA's relentless drive to restrict
access to ephedra. This time, apparently, they decided that they couldn't
continue to let facts stand in their way.
-
- The question is: why was it so important to the FDA to
regulate a seemingly innocuous dietary supplement that the truth became
irrelevant?
-
- The active ingredient in ephedra, ephedrine, remains
legally available in dozens of over the counter cold and flu remedies used
by millions of Americans. Those very profitable products are made by big
pharmaceutical companies while supplement manufacturers are generally small
fry who rarely make the kind of political contributions that would put
them on the Bush administration's radar screen. Once a substance is regulated
and becomes available only by prescription the price goes up enough for
Big Pharma to profitably step in. Was the possibility of benefiting friends
one of the FDA's reasons for making war against ephedra?
-
- The FDA has a long and unsuccessful history of attempting
to regulate the dietary supplement industry. Past attempts have resulted
in a deluge of protests from users who want the FDA to leave them alone.
This time the FDA saw an opening and acted fast, with more regulation and
control surely on the horizon. They decreed a shortened period for public
comment, instituted a public relations blitzkrieg, and used data so mushy
that even they can't realistically believe it would prevail in an impartial
court of law. Support from a complicit and unquestioning media was a foregone
conclusion. Plus, the cost to contest the ban might well be prohibitive
for the small businesses involved in the diet supplement industry, so it
would most likely remain intact. Were the low political risk and high probability
of success parts of the FDA's strategic plan?
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- And then there is the general impotence of the FDA on
important questions of food and drug safety. The onslaught of genetically
modified and untested organisms in the U.S. food supply, the frightening
number of deaths from food poisoning every year, and, worst of all, the
staggering death rate from properly prescribed and used prescription drugs
- we can safely assume that none of these would be the first choice of
dedicated FDA professionals. Those problems, however, involve intractable
political constituencies over which the FDA is currently powerless. Not
so with the food supplement industry. Was ephedra just a target of opportunity?
-
- Whatever the reasons for the Bush Administration's ban,
evidence that it was harmful to the public was not one of them. The FDA
banned ephedra because it could. What's next?
-
- Dr. Sidney Wolfe also used the RAND report to justify
his graceless and backhanded support of the FDA's action. Maybe his cavalier
dismissal was an example of physicians'; characteristic disdain for non-pharmaceuticals.
Or maybe he just didn't bother to read it.
-
- Sandy Jewell is a statistician and public health researcher.
She can be reached at jolyjuly@earthlink.net.
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