If we were in the business of selling
garlic, the following sentence could land Viable Herbal Solutions in a heap of
trouble: "Garlic reduces cholesterol."
The statement is true! But no
Company that sells garlic is allowed to tout its proven health
benefits.
Welcome to the Alice-in-Wonderland world
of the Food and Drug Administration (FDA), a topsy-turvy realm where the agency
responsible for protecting the nation's health winds up threatening it. "The
FDA knows little, if anything, about medicinal herbs," explains Varro Tyler,
Ph.D., the Lilly Distinguished Professor of Pharmacognosy (natural product
pharmacy) at Purdue University. "As far as the public health is concerned, FDA
regulations governing medicinal herbs do more harm than
good."
The above claim is not a lie: Garlic does
reduce cholesterol. Earlier this year, the Journal of the Royal College of
Physicians of London, a prestigious medical journal, analyzed 16 studies to
conclude that, compared with people who took placebos, garlic users showed an
average cholesterol reduction of 12 percent. A similar review of other studies
last year in the Annals of Internal Medicine showed that eating just one clove
of garlic a day reduced cholesterol levels an average of 9
percent.
Few Americans understand garlic's value,
but they should. A high cholesterol level is a significant risk factor for
heart attack, the nation's leading killer. Heart attacks now hit 1.5 million
Americans a year. Studies suggest that garlic might help prevent up to 360,000
of them - or 30,000 a month - an astonishing benefit for any present day
therapy.
And garlic costs only pennies per clove.
It requires no prescription, adds zing to low-fat diets, and causes no side
effects (unless you're offended by garlic breath, in which case, another
medicinal herb, parsley, can minimize it).
Doctors increasingly recommend a low-fat
diet for cholesterol control. But instead of garlic, physicians promote
prescription drugs like Cholestyramine (Questran). Cholestyramine is effective,
but it costs $1 to $2 a day, requires regular professional monitoring that adds
to its cost, and may cause side effects, notably constipation, vomiting, loss
of appetite, bleeding, and vitamin deficiencies. In addition, animal research
hints that Cholestyramine might accelerate tumor growth.
What we have here is a public-health
no-brainer. Some people with super-elevated cholesterol levels might still need
a synthetic drug like Cholestyramine, but everyone with high cholesterol should
be encouraged to eat at least one clove of garlic a day.
Unfortunately, if
growers or marketers attached this information to bags of their aromatic bulbs,
the FDA could confiscate their garlic. Ditto if they reprinted it in a pamphlet
and mailed it to consumers or supermarket produce buyers.
Why? Because under FDA regulations, using
garlic to reduce cholesterol makes the culinary herb a "drug." To the FDA, the
assertion that "garlic reduces cholesterol" constitutes a "new drug claim." The
FDA has never approved this claim, and it is a violation of FDA regulations to
make un-approved claims on drug labels or promotional
materials.
U.S. drug regulations made their first
modern appearance in 1906, when "The Jungle," Upton Sinclair's indictment of
the meat-packing industry, convinced a grossed-out Congress to pass the Food
and Drug Act. The law created what is now the FDA, but it gave the agency no
enforcement authority. The Food, Drug, and Cosmetic Act of 1938 rectified that,
giving the FDA the authority to set, and enforce, drug safety
standards.
The FDA remained pretty laid-back until
1961, when about 8,000 babies worldwide were born with malformed arms and legs.
Investigators quickly found the cause - a thalidomide, an over-the-counter
sedative sold in several European countries. The thalidomide scandal spurred
the U.S. Congress in 1962 to direct the FDA to require safety and effectiveness
testing for new drugs.
Those standards were so rigid that they
threatened not only herbs, but also hundreds of over-the-counter (OTC)
pharmaceuticals. To address this issue, the FDA appointed panels of physicians,
pharmacists, and pharmacologists to write monographs determining if drugs
already on shelves were safe and effective. The OTC Review Panels mainly
examined data submitted by manufacturers and other concerned citizens. The OTC
monographs, which are being finalized now, incorporated hundreds of drugs, and
some medicinal herbs, including the active ingredients in many OTC laxatives
(senna, psyllium seed, and cascara sagrada) and a few decongestants (peppermint
oil and eucalyptus oil). But the approved herbs represented only a tiny
fraction of the hundreds of botanical medicines with extensive historical and
clinical evidence of safety and efficacy.
Despite America's long history of using
herbs, herbalism had almost died between the 1930s and the 1960s, the victim of
antibiotics' miraculous effectiveness. Only since the mid-1970s have Americans
become skeptical enough of high-tech pharmacology to fuel today's modest Herbal
Renaissance.
At the time of the OTC review, however,
the resurrection of herbal medicine had barely begun. The herb companies that
did exist in the 1970s and early 1980s, when the review panels did most of
their work, were run by mom-and-pop herbalists who sold medicinal teas at local
health food stores. While these people knew the review was taking place, for
the most part they lacked either the money or the political 'will' to
participate.
When they did organize, it was already
too late. "We would have tried to submit data to several OTC Review Panels,"
says Lynda Sadler, president of Traditional Medicinals, an herb company in
Sebastopol, Calif. "But the public comment period was already over, and that
was that."
Having missed the review process, herbal
missionaries now have to file a New Drug Application (NDA). Today's major drug
companies claim that this process costs $230 million per drug
approval.
The FDA contests that figure, saying that
drug companies add in the cost of testing drugs that fail the approval process.
So let's assume that the approval process costs less than half of what the drug
companies claim…..say only $100 million. And let's pick “garlic”
to push, since persuasive studies already exist showing that garlic reduces
cholesterol; therefore we can assume that an herb marketer wouldn't have to
finance much, if any, new research. So the NDA process for garlic could
conceivably cost as little as 1 percent of the $100 million figure, or $1
million…..an amount that a large herb company or garlic grower might be
able to afford.
But here's the catch: When a drug company
wins approval for a new drug, it also gets a patent with exclusive rights to
market that drug. "But who in their right mind would spend $1 million on a new
drug application for garlic?" asks James Duke, Ph.D., a senior botanist at the
U.S. Department of Agriculture. "They could never recoup the investment,
because they could never hold exclusive rights to an herb that anyone can grow
and use themselves."
In 1990, Congress passed the Nutritional
Labeling and Education Act (NLEA), allowing foods, including vitamins and
herbs, to carry approved health claims. So far, the FDA has allowed claims that
fiber helps prevent certain cancers, that calcium prevents osteoporosis, and
that folic acid helps prevent spinal birth defects.
The FDA claims to be
"very open" to NLEA petitions for medicinal herbs. But Loren Israelsen, a Utah
attorney specializing in natural-product regulation, says that the NLEA
regulations make it "difficult, if not impossible, for herbal products to win
approval."
And, unfortunately, an NLEA petition
poses the same sticking point as an NDA: No herb company will pay for the
approval when it can't win the exclusive marketing rights that will allow it to
recoup its investment.
Germany, on the other hand, has a much
different drug-approval process…..one that's considerably more open to
herbal medicines. Like the FDA, Germany requires pre-approval testing for all
new synthetic pharmaceuticals. But it does not hold herbs to so high a
standard.
In 1978, the former West Germany's
FDA-equivalent agency began to study the enormous scientific literature on
medicinal herbs. Over the last 15 years, the agency has published 285
monographs that Tyler calls "probably the best information available today on
[herbs]." Today, an estimated 70 percent of German physicians routinely
prescribe herbal medicines, with their cost generally covered by German
government health insurance. At a German pharmacy, right next to brands like
Sominex and Nytol, you will find OTC herbal sedatives containing
valerian.
Canada has a similar process. In Canada,
medicinal herbs fall under the regulatory authority of the Health Protection
Branch (HPB). In 1986, recognizing the increasing popularity of herbal
medicines, the HPB created a new drug category, now officially termed
"Traditional Herbal Medicines." They have yet to approve many herbal claims.
"But at least," says Mark Blumenthal, executive director of the American
Botanical Council, a nonprofit that sponsors herb research, "Canada is moving
in the direction of allowing herbal medical claims."
Herbalists wish the United States would
adopt a similar system. But mention Germany, and FDA officials cringe: "Most of
the thalidomide babies were born in Germany," says FDA Public Affairs
Specialist Janet McDonald. "The Germans let drugs on the market with much less
pre-approval testing than we insist on. When problems develop, as they often
do, they withdraw them."
German drug-approval standards may not be
as strict as ours, but the results have been quite similar. In fact, from 1976
through 1985, more than half of the new prescription drugs approved by the FDA
(102 of 198) were later found to cause unanticipated reactions serious enough
to warrant re-labeling or withdrawal.
The current state of medicinal herb
regulations leaves most U.S. consumers confused, and misled, about how herbs
might help, or harm, them. In an effort to get information, some consumers turn
to medicinal herb guides ("herbals"), but many contain inaccuracies, and few
mention possible side effects or discourage use by pregnant
women.
Others turn to health food store
personnel, who may not know much - at least according to the FDA. Last year,
the agency asked staffs at 129 health food stores to recommend natural
therapies for a variety of ailments. Employees at 120 of the stores made
recommendations the FDA considered improper. But health food store personnel
are not responsible for safeguarding the public health; the FDA is. And the
main reason that health food store personnel don't know as much as they should
is that the FDA prohibits informative labeling of medicinal herbs.
The World Health Organization estimates
that 80 percent of the world's population currently uses herbal medicines. More
than one-third of Americans now use non-mainstream approaches to meet at least
some of their medicinal needs….and that number is growing. American health
care costs have soared, and the Clinton administration has identified drug
industry profits as a significant part of the problem.
Today seems like a perfect time for the
FDA to move forward into our medical past.
It's time to rethink the
regulation of herbal medicines…..just as Germany has done, and as Canada
is doing. The FDA should create a "traditional herbal medicines" category, and
appoint experts to draft monographs on the effectiveness, safety, cautions, and
labeling of herbs. Just as they are free to take vitamins and mineral
supplements, Americans should also be able to choose what they take for such
conditions as motion sickness, indigestion, anxiety, insomnia, immune
deficiency, nicotine addiction, and urinary tract infection.
