Every year, the largest increase in the
U.S. gross national product is in the medical sector.
It's been estimated that $600 billion could be trimmed yearly
from our $1.3 trillion medical bill if we were to eliminate al
unnecessary, overused, unproved, and dangerous
procedures. We have 100 million what I call
"medical refugees" in this country- people who have
given their absolute trust, faith, and life savings to the
orthodox approach, only to find that this route has failed
them. In recent years these people have begun to look
elsewhere for answers-resulting in big medicine, the
pharmaceutical establishment, and their allies in big
government all joining forces to protect their own interests.
These threatened groups engage in fear-mongering before
Congress to get legislation that would sic state medical
boards on alternative therapies, let dietitians control the
dispensing of nutritional advice, and keep the public from
having freedom of choice by turning as many nutrients as
possible into prescription drugs. This is what the future will
bring unless we take action.
Not far into the twenty-first century you
may be saying so long to your St. John’s Wort, goodbye to
your ginkgo biloba. These and many other supplements may
become things of the past, at least as reasonably priced
over-the-counter items.
Picture the following scenario: It’s
winter, in a year just past the start of the new millennium.
You’ve been pushing yourself a little too hard, and you feel
a cold coming on. You decide to get some
vitamin-C-plus-bioflavonoid tablets; this particular
supplement also contains selenium and has helped you keep cold
symptoms at bay many times in the past. Taking some now seems
like a prudent thing to do. So you pick up the phone and call
your doctor to make an appointment. When you finally get
through and can talk to a human, you are told that the
doctor-your primary-care physician- is really busy, and so are
all his associates in the HMO, but luckily they can squeeze
you in two days. Two days later your cold is already hitting
full force, and it’s snowing heavily, but you figure, what
the heck, the supplements may still help. So you decide to go
ahead and get them. After bundling yourself into the car, you
drive several miles past the local drugstore to the doctor’s
office. There, after languishing for an hour and a half in the
crowded waiting room, you see the doctor for a cursory
four-minute examination, during which you blood pressure’s a
little high because you’re nervous about getting the
tablets. But your powers of persuasion are good-you explain
how many times the C-plus-bioflavonoid supplements have worked
for you in the past- and the doctor’s a nice guy anyway.
Triumphant, you leave the office tightly clutching your little
white script.
"Yes!" you say to yourself.
"I’ve done it! I’ve got my prescription!"
In the car again you drive over icy roads
the several miles homeward, stopping at the drugstore. You
give the prescription to the pharmacist, who, like the doctor,
is swamped with work. You’re stuck cooling your heels in the
store aisles for a good 20 minutes until the pharmacist has a
chance to fill the prescription and you can pay for it. Once
you’re home, the feeling of triumph you had in the
doctor’s office has faded somewhat. It’s been a long day,
full of waiting. At the end of it, you had to pay what seemed
like a small fortune to get a few tablets. Plus by now your
cold really has you in the its grip. You think back fondly to
the days when you could stroll down to the drugstore anytime,
pick whatever vitamin, mineral, herb, or other nutritional
supplement you wanted right off the shelf, and pay a
reasonable amount of it.
"Ah for the good old days," you
say to yourself, "the days before Codex Alimentarius got
its way"
Codex Alimentarius, which means "food
code" in Latin, is the name of a United Nations
commission that operates as part of the World Health
Organization. The Codex Alimentarius Commission’s mandate is
to set international standards for trade in all kind of food
products. Its concerns include raw-and processed-food
standards, pesticide and other contaminant levels, nutritional
content, and labeling. Codex also is concerned with global
trade rules for health supplements, and it is what the
commission is aiming to do in this field that is really scary.
First, the Codex Alimentarius Commission
wants to establish a world guideline saying that no dietary
supplement can be sold for preventive or therapeutic purposes.
Actually, in the U.S. we already have a labeling constraint to
this effect: The Dietary Supplement Health and Education Act
of 1994 prohibits claims on supplement labels that relate to
treatment or prevention of disease other than classic
nutrient-deficiency diseases, like scurvy. That’s why our
vitamin bottles don’t tell us much about what their contents
are good for-they’re not allowed to.
Second, the Codex-Alimentarius Commission
wants to limit over-the-counter sales of dietary supplements
to those of low or R.D.A. dosage, the kind that prevent
deficiency diseases but not chronic diseases like cancer.
Dietary supplements of higher potency-the dosages that work to
fortify the immune system and stave off aging and chronic
disease-would become pharmaceuticals. You would have to get
them from a pharmacist.
Today, many of the newly popular
supplements, such as those being taken for their
immune-enhancing powers, have never been assigned a
recommended daily allowance. These R.D.A.-less substances,
such as bioflavonoids, selenium, chromium, and coenzyme Q10,
also would be classified, according to the Codex scheme, as
drugs, meaning you’d need a prescription to get any of them.
And there’s more on the Codex agenda. The group wants all
new supplements to have to be approved by the commission
before becoming available. Without approval there’d be no
legal sale anywhere. That’s another aspect of what the Codex
Alimentarius Commission wants to do- it wants to make its
guidelines universal. The General Agreement on Tariffs and
Trade that the U.S. and other nations have signed contains an
escape clause on regulations that allows us to set our own
standards. But Codex wants to eliminate that clause and force
Americans into the commission’s restrictive system. It
speaks in terms of governments "harmonizing" their
rules so that everyone in the world sticks to the same
standards. "Harmonizing" their rules so that
everyone in the world sticks to the same standards.
"Harmonization" might be a nice concept if you were
talking about the whole abiding by some minimum standards on
democracy, decent wages, human rights.
Unfortunately, in this case the harmonized standards will mean
nothing less than the loss of our capacity to maintain and
care for our own bodies in the ways we judge best. We’d be
losing the ability to educate ourselves on how to enhance
health and then act on what we’ve learned. The gainer in all
this would be the medical establishment, particularly the
large pharmaceutical companies. What it boils down to is that
there’d be a medical monopoly controlling our very body
chemistry.
Sometimes threats to our freedom remain in
the shadows until it’s too late. That may turn out to be the
case with the Codex Alimentarius Commission, which certainly
has not been a household term in America. Our media seem to
have been asleep at the wheel when it comes to reporting on
this outfit.
The Coded Alimentarius Commission, composed
of member governments, exists under the joint auspices of the
UN’s World Health Organization and Food and Agriculture
Organization as part of a food-standards program. The
commission meets in Rome or Geneva every two years, with
smaller get-togethers in various locales all over the world at
other times. While it is concerned with protecting the health
of consumers, it’s also a trade group, and of the
international organizations that send delegates to Codex, more
that 90 percent represent large multinational corporations.
Codex is not an organization in which the
American public- or any other country’s public, for that
matter- is given a voice. Although there’s a one-nation,
one-vote rule, those representing their respective countries
are unelected bureaucrats. There is no system of
accountability where- by these bureaucrats would have to face
the citizens whose lives their decisions affect. The Life
Extension Foundation, a watchdog group that has taken the
trouble to look into the goings-on at Codex meetings, gives
details on the group’s workings:
"The Codex Alimentarius Commission as
an international body makes little or no provision for the
minimum requirements of representative governance. For
example, Codex Committee chairmanships can and have remained
vested in the hands of a particular nation-state for decades
at a time, with no mechanism for either rotation of
chairmanships or accountability for the acts or particular
nations as the chair of a particular committee. Many nations
have retained chairmanships in an uninterrupted fashion for
the last 30 or more years."
The watchdog organization goes on to
explain that "committee chair nations wield considerable
power under the Codex system, since a chair nation is
responsible not only for the costs associated with the
assumption of that role but also for the shepherding of
committee recommendations throughout the Codex process. The
Codex process contains no meaningful system of accountability
for acts of chair nations or mechanism for containment or
review of the considerable powers wielded by chair nations.
The Life Extension Foundation also points
out that meaningful consumer representation at Codex is
virtually nil. And it has this to say about the U.S.
delegation to the organization: "Within the United States
delegation, the voting delegate is assisted by a group of
nonvoting delegates who are selected by either the Department
of Agriculture and/or the Food and Drug Administration under
an ill-defined and unregulated system in which the agencies
openly represent vested commercial interests or commercial
interests thinly disguised as consumer groups, with nor
requirement that genuine consumer or public interest be
represented at all."
"Consumers
took a hit in their wallet,"
said Attorney General Reno,
"so that these co-conspirators could reap
hundreds of millions of dollars."
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The Codex story gets even more interesting
when you find out who’s behind the proposed new rules. The
proposals were originally put forth by
the German delegation to the commission, a
panel sponsored by three giant drug companies- Hoechst, Bayer,
and BASF. These are none other than the daughter companies
formed after World War II when Nazi Germany’s notorious I.G.
Farben cartel was disbanded. (In May of this year, two federal
class-action lawsuits were filed against Bayer AG, Hoechst AG,
and Schering AG, charging these German companies with
participating in Nazi medical experiments, some of which were
under the direction of Dr. Joseph Mengele.) As the Life
Extension Foundation points out, it is such companies that are
now the firmest supporters of the proposals that would so
drastically curtail our healthcare freedoms.
(Earlier this year BASF and the Swiss drug
company La Roche Holding AG pleaded guilty to the largest
antitrust conspiracy to fix vitamin prices uncovered to date.
They agreed to pay fines of $500 million and $225 million,
respectively, for raising and fixing vitamin prices and
allocating their volume of sales and market shares. "Day
by day," Attorney General Janet Reno said,
"consumers took a hit in their wallet so that these
co-conspirators could reap hundreds of millions of dollars in
additional revenue.")
It’s instructive to look at the
supplement situation in Germany today; one can get an
indication of the way things would go if the Codex proposals
are adopted. In germane, until 1996, one could buy, freely,
500mg vitamin-C tablets, the way you can here. Now the highest
dosage generally available to Germans is 200 mg; anything
higher is sold through pharmacists only- at extremely high
prices. Likewise, generally available vitamin E capsules go up
to 45 I.U. only, and B1 is limited to 2.4 mg.
Other countries also provide a preview
of what may be ahead for the U.S. In Norway, all supplements
that exceed R.D.A. levels are considered drugs. Examples of
cutoff potency levels are 200 mg of vitamin C, 2.4 mg of B1,
2.8 mg of B2, 4.2 mg of B6, and 32 mg of niacin. Many natural
substances are available in Norway only through the very
costly prescription route, if they’re available at all. A
black market in supplements has emerged. In England, it
recently took the objections of a large consumer lobby to
defeat a measure before Parliament that would have banned
vitamin B6 beyond the less-than-therapeutic dosage of ten mg.
And in Europe as a whole, the European Economic Community has
said that if an herb is medicinal or affects physiological
function in any way, it is a medicine and should be sold as a
drug.
Closer to home, in Canada, herbs with
medicinal effects- this is, any herb for which claims are made
that it improves health- are classified as drugs. The
supplements tryptophan and L-carnitine, once available in
Canadian health-food stores for $14 per 100 capsules, are now
available only by prescription- for $120 to $190. In the U.S.,
what’s happened with tryptophan may be indicative of our
future direction. In 1990, after a batch of the amino acid
turned out to have been contaminated, the F.D.A. banned sales
of tryptophan completely. But the substance is now available
by prescription at highly inflated prices. If Americans do not
take notice of the worldwide trend toward medicalization of
nutrient, many of the supplements that we now take for granted
we will not be able to take at all.
The medicalization of nutritional
supplements might not be such a bad thing if the
medical/pharmaceutical complex were in the habit of working in
the public’s best interest. But anyone who thinks that this
is the case is being naïve. You don’t have to look further
than that bastion of the establishment The New York Times
to see how pharmaceutical companies team up with physicians in
the latest kind of pharmaceutical sleaze.
The results of a ten-moth Times
investigation, reported on May 16 of this year, show that
there’s a widespread conflict of interest when doctors
recruit patients for clinical trials of experimental drugs.
When a doctor gets a patient to enroll in a clinical trial,
chances are good that that doctor is paid a hefty free-from
about $1,000 to more than $4000- for each enlistee. A
physician can significantly augment his income if he or she
aggressively recruits patients into testing programs. The
problem, of course, is that with the monetary incentive
doctors are tempted to fudge on the requirements and
restrictions as to who can safely participate in the study.
And, as the Times story revealed, this happens all too
frequently. Doctors overlook contraindications to a
patient’s taking a particular drug. Or they enroll people in
a trial who have no need for a drug at all. The power gap
between doctor and patient is so great that most patients are
going to agree to whatever the doctor suggests without
question. Plus most patients hearing a recommendation to enter
a clinical trial have no idea that money is changing hands
practically as the doctor speaks.
This didn’t used to be the way things
worked in the pharmaceutical-research field. As recently as
the 1980s, testing of drugs was done largely by university
doctors, with no monetary incentive for patient recruitment.
But in the past decade, with the rise of managed care and its
power to curtail the price drug companies can charge per
prescription, the companies realized that the way to pump
profits back up was to come out with new
"blockbuster" medicines at a faster rate than
previously. To quicken the pace of clinical testing they came
up with the newest twist on fee-splitting- this scheme of
paying doctors incentives include not just a per-person fee,
but rewards for recruiting a certain number of subjects within
a specified time, as well as "coauthorship" of
trial-result articles that are in fact written not by the
doctors, but by drug-company or research-company ghostwriters.
Research companies are another new
development. It used to be that pharmaceutical companies
guided their own research. Now they’re outsourcing it to new
firms that have sprung up ready to take care of every aspect
of research, from designing studies to finding doctors who
will participate to writing papers to submitting documentation
to F.D.A. Unfortunately, the whole process seems shot through
with shoddiness. Beyond the ethical question of doctors being
offered incentives to recruit patients is the reality that
many doctors chosen by the research firms to do recruiting
should not have been selected because they’re not
specialists in the field for which they’re testing
medicines. This seems not to worry the research companies,
which aren’t picky about the experience of the doctors who
are handing out unproved medicines. The name of the game these
days is speed in turning out new drugs- not expertise in
helping patients.
The result of such shady dealings by the
pharmaceutical industry is not just its enrichment to the tune
of several billion dollars. Much more serious is the sometimes
life-or-death risk these practices pose for patients. And so
the question becomes, is our F.D.A., which is supposed to be
looking out for our lives, really doing so? The search for an
answer leads to some troubling facts.
Consider, for instance, that of 198 new
drugs introduced from 1976 to 1985, more than half caused
unexpected side effects and had to be withdrawn or relabeled.
Or consider a 1998 study reported in the Journal of
American Medical Association. Serious adverse drug
reactions were found to occur in almost seven percent of
hospitalized patients. These were not errors of dosage or
noncompliance with instructions, but simply bad reactions to
the drugs. Such reactions the JAMA authors revealed,
were between the fourth-and sixth-leading causes of death.
Or look at specific drugs that the F.D.A.
has approved. In 1997 the diet drugs fenfluramine and
dexfenfluramine were pulled from the market after they were
linked to serious irreversible heart problems- and to deaths
– when they were used with another drug, phentermine. This
so-called fen-phen combination had been a widely advertised
and prescribed drug duo used by people trying to lose weight,
people who never suspected their hearts could be seriously
damaged in the process. The billion-dollar-lawsuit aftermath
of this tragedy is only beginning to be felt. Other popular
medications approved by the F.D.A. include those called
nonsteroidal anti-inflammatory drugs, used to treat, among
other conditions, arthritis. According to Stanford University
researcher Dr. G. Singh, writing in the American Journal of
Medicine, "Conservative calculations estimate the
approximately 107,000 patients are hospitalized annually for
nonsteroidal anti-inflammatory drug (NSAID)-related
gastrointestinal complications, and at least 16,500
NSAID-related deaths occur each year among arthritis patients
alone.
A drug that has been much touted of late is
tamoxifen, which recently gained F.D.A. approval to be used as
a breast-cancer preventive by healthy women deemed at high
risk for the disease. While tamoxifen has been used to prevent
recurrence of breast cancer in those who have already had the
disease, okaying its use by healthy women is troubling for a
number of reasons.
For one thing, there’s the question of
who’s really at high risk. The computer models used to
determine risk are often little more than informed guesswork
(for example, according to the Los Angeles Times,
"the National Cancer Institute computer model that most
doctors use to assess risk does not take genetics into
account, nor the ages at which close relatives contracted the
disease"). The reason this is such a critical point is
that the women placed in this category are now being
encouraged to take a drug that is not a benign substance. Tamoxifen
carries with it a number of risks, just one of which is that
it can cause endometrial, or uterine, cancer.
Giving cancer patients a drug with risk
attached is understandable. But encouraging healthy
individuals to take a carcinogenic substance is ethically
questionable, to say the least. Recently, Judy Norsigian of
the Boston Women’s Health Collective was quoted as saying
such practices were "disease substitution, not disease
prevention." And yet the F.D.A. approved the drug for use
by the healthy. It should be noted that in doing so it opened
up a market worth billions of dollars annually.
"The
F.D.A. seems to relish conducting storm trooper -
like raids on small business selling supplements
that the agency has problems with."
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Having sweetening power is allowed in their
marketing. So you have the phenomenon of F.D.A. compliance
officers getting after the Stevita Company, of Arlington,
Texas, to destroy "offending" cookbooks and other
literature, and of attempting to regulate Internet Websites
dealing with the herb. James Kirkland, author of the book Cooking
With Stevia, has made the point that his book is illegal,
while a volume called the Anarchist’s Cook-book,
which tells how to construct homemade bombs, is not. The
situation would be humorous if it were not so serious.
A situation that is definitely not humorous
involves folic acid. The U.S. Public Health Service was
imploring childbearing-age women to take folic acid to prevent
birth defects for two years before the F.D.A. finally approved
the labeling claim. Folic acid, taken before and during
pregnancy, has been shown to prevent babies from born with
spina bifida, a condition that causes partial to full
paralysis, permanent deformity, an shortened life span. It’s
been estimated that during the two years the F.D.A. dragged
its feet on allowing claims to this effect, more than 3,500
children were born with spina bifida- a tragedy that could
have been prevented had their mothers taken folic acid.
In another area, many people today are
trying to lower their cholesterol levels, and you would think
that a safe way to help do this would be welcomed by the
F.D.A. But one of the over-the-counter herbal products that
the F.D.A. A. has been trying to declare an illegal drug is
Cholestin, which is made from kind of Chinese rice fermented
with red yeast and is used as a cholesterol-lowering agent.
The F.D.A. recently impounded ten tons of the red yeast rice,
but a court ruled that the manufacturer could continue making
Cholestin while legal wrangling goes on. Cholestin is a
natural supplement based on a 2,000-year-old Chinese product.
The problem seems to be that it threatens the more expensive-
and riskier – prescription cholesterol reducers.
The F.D.A. seems to relish conducting raids
on small business selling supplements that the agency has
problems with. Their storm trooper-like tactics, while not
widely publicized, have not been appreciated by those
affected. One example: In October 1990, according to the National
Review, "an F.D.A. sting operation led t a raid on
[the home and business of Kenneth Scott, the owner of a small
Oregon vitamin company] by 11 armed federal marshals, nine
F.D.A. agents, and a horde of local and state police
officers." What was Scott’s crime? He was mailing
reprints of an article from Omni magazine to customers
who requested them. Because the F.D.A. did not approve of what
the article reported about an ingredient in one of Scott’s
products, it told Scott that it considered his mailing the
article as "labeling." Scott eventually decided that
he didn’t have the time and money to fight the feds and cut
a deal with them.
Another example from 1990: Solid Gold Pet
Foods, a California store that sold holistic pet-food
products, was raided by the F.D.A. and its owner imprisoned
for 114 days, because, according to the Washington Times,
"a judge ruled that claims concerning her natural pet
food were unsubstantiated." The newspaper went on to
report that she "was released only after President Bush
revised legislation on food labeling."
Another example also involves a California
company, this one called Nutricology. In 1991 it was raided by
the F.D.A., which seized the firm’s bank accounts and shut
it down for two weeks, charging its principals with wire
fraud, mail fraud, and selling unapproved drugs, unsafe food
additives, and misbranded drugs. Armed agents conducted an
exhaustive search of the company’s office and warehouse. In
1991 a federal judge denied the F.D.A.’s request for a
preliminary injunction, and so did an appeals court to which
the agency turned. In 1993, the F.D.A.’s motion for summary judgment
was denied, and the company is still thriving.
Although in some cases there is vindication
for health-food businesses, in many instances of F.D.A. raids
the small-business people involved are totally intimidated and
ruined. As Nutricology president Stephen A. Levine said when
his company was under attack, "The F.D.A. will wipe out
our entire industry if we left them."
The flip side of all the bad news about
F.D.A. shenanigans and about risky new drugs is an avalanche
of good news about the healing powers of natural supplements.
That’s what makes the impending Codex actions to restrict
our access to the so excruciatingly ill timed. Let’s look at
just a few of the encouraging studies.
First, have you heard about the Linxian
trials? Probably not. Linxian is an area in China. The trials
there had nothing to do with court cases, but with a joint
effort by the U.S. National Cancer Institute and the Chinese
Academy of Medical Sciences to see if daily ingestion of
vitamin/mineral supplements would reduce cancer incidence and
mortality. Results of the experimental trials, which involved
more than 30,000 people, showed that a beta-carotene/vitamin
E/selenium combination had a significant preventive effect for
stomach and esophageal cancer, and for stroke as well.
Another study, in another area, involved
multivitamin supplements and H.I.V.-infected women. Reported
in 1998 in the British medical journal The Lancet, this
study showed that multivitamins improved pregnancy outcomes
for these women significantly reducing rates of fetal death,
as well as low birth weight and other problems for the babies.
What’s more, the low-cost vitamins improved the women’s
T-cell counts, a sign that their immune systems had benefited.
Studies on fish oil have been noteworthy in
the medical literature lately. For instance, in a 1997 study,
fish oil, compared to a placebo, lowered the number of
"cardiac events" in a group of patients with
suspected heart attack. Another study, published the same
year, in the Journal of the National Medical Association,
involved fish oil and garlic. This seemingly lowly combo did
great things when taken as a supplement for a month. Unlike a
placebo, which did nothing, the supplement lowered total
cholesterol 11 percent, triglycerides 34 percent, and
low-density lipoprotein ten percent. Things went swimmingly
for fish supplements in still another study, reported in the
journal Cancer in 1998. In that one, the omega-3
polyunsaturated fatty acids of fish oil were shown to lengthen
survival time of cancer patients.
In human health, this is a time of
opportunity, and of challenge. Information about the benefits
of vitamins, minerals, herbs, and other natural supplements is
growing daily. We have an opportunity to make our lives
healthier and longer by putting this new knowledge to use.
Indeed, many Americans are already doing so, as indicated by
the latest estimate that 100 million of us are taking vitamins
on a regular basis. And Americans in record numbers are
seeking out complementary approaches to medical care, be they
nutritional counseling, chiropractic, acupuncture,
stress-management techniques, or other avenues to health. When
I travel the country on lecture tours, I get a sense that the
people are hungry for ways to go beyond what the medical
establishment has to offer.
This is not to say that the traditional
medical establishment has nothing of value to offer. It has
brought us many lifesaving innovations, including emergency
and post-trauma care and, yes, drugs. Antibiotics, for
instance, have been miracle medicines, and it’s not the
fault of the developers of antibiotics that they’ve been so
overprescribed that antibiotic-resistant bacterial strains
have now developed. The problem with mainstream medicine is
that it hasn’t been good at dealing with the chronic
conditions plaguing us today, such as cancer, heart disease,
arthritis, and depression, The magic-bullet approach that
orthodox medicine is geared to just doesn’t work with these
– because, first, magic bullets tend to have side effects,
and, second, to really make a dent in these chronic
conditions, you have to make lifestyle changes.
That’s what the challenge we face today is about. We
finally want to make lifestyle changes. We finally want to
give natural supplements a real try because we’re learning
more about what they can do. But there are forces now that are
trying to prevent us from freely choosing these alternatives.
Our challenge is to educate ourselves about those who would
lay siege to our freedom of choice, and then figure out how to
counter them.