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Diagnosis: Corruption
by
Bill Sardi
by Bill Sardi
The
Federal branches of government responsible for protecting and promoting
public health are in a state of moral collapse. The recent recall
of the anti-inflammatory drug Vioxx, with the revelation that the
continued use of the drug long after the Food & drug Administration
and its manufacturer knew it doubled the risk of heart attacks and
may have caused 30,000 or so avoidable deaths, is only a small picture
of what is going on inside federal health agencies today.
The
annual Federal budget is around $2.294 trillion. About
$800 billion of that is defense spending (about half of that figure
is hidden and doesn’t appear on the budget pie charts) For comparison,
the combined 2004 budgets for three federal health organizations,
the National Institutes of Health ($28.5 billion), the Centers for
Disease Control ($4.8 billion), and Food & Drug Administration
($1.7 billion, including $300 million in user fees from pharmaceutical
companies), represent a relatively small portion of the Federal
annual spending. But more money won’t fix what’s wrong with Federal
health agencies. In fact, it is money that has corrupted these once
respected public agencies.
Here’s
what these agencies claim they are doing for you.

According
to the above chart, research in the prevention and treatment of
cardiovascular disease, supported by the National Institutes of
Health, has helped to save over 800,000 lives annually. Elias Zerhouni,
MD, Director, National Institutes of Health (NIH), in his April
8, 2003 presentation before the 108th Congress to support
2004 budget requests, said: "We supported research that
led to strategies as simple and inexpensive as taking aspirin to
prevent heart disease and stroke"…. and "we also
continue to evaluate the best therapeutic strategies in medical
practice" including cholesterol-lowering trials and other
studies that "showed that hypertension can be effectively
managed with an initial choice of an inexpensive drug."
What Dr. Dr. Zerhouni was talking about was a report issued in 1993
showing that an inexpensive diuretic (water pill) can significantly
reduce the risk of stroke and death from high blood pressure.
But
there is a problem with Dr. Zerhouni’s claims. Diuretics were recommended
in practice guidelines, but numerous studies indicate physicians
largely ignored the advice to use diuretics as first-line treatment
for high blood pressure. The NIH-sponsored studies didn’t significantly
change the percentage of patients receiving diuretics. [Am J Med113:528,
2002; Clin Therapy 24:145162, 2002; Value Health 6:1828,
2003] Norwegian health authorities claim the NIH-sponsored studies
were "unfit as a basis for general guidelines in the treatment
of high blood pressure in Norway." [Tidsskr Nor Laegeforen
124:141920, 2004]. To show what a mess the practice of medicine
is in today, one study showed that physicians were more likely to
select a drug for hypertension based upon the supply of free samples
provided by pharmaceutical representatives rather than the NIH study.
[J Gen Intern Med 18:97783, 2003]
Look
carefully at the above chart provided by the NIH. The use of aspirin
wasn’t recommended by the American Heart Association till 1993.
Shortly thereafter the NIH sponsored-studies recommended diuretics
over other more expensive blood pressure medications, but the use
of diuretics did not significantly rise. Furthermore, the first
statin cholesterol-lowering drug (Mavacor) was not introduced till
late 1987. The dramatic drop in cardiovascular mortality rates occurred
prior to the recommendations to use aspirin, diuretics or cholesterol-lowering
drugs.
What
happened, starting in 1970, which would have caused such a dramatic
drop in cardiovascular mortality? Cigarette use per capita per year
began to decline from 4000 to 2000 in the period from 1970 to 2000
but the number of smokers (about 40+ million) remained about the
same due to gradual increases in the size of the population and
the number of cigarettes consumed per day per smoker remained about
the same. It is difficult to pin down what caused the dramatic drop
in cardiovascular disease mortality. It wasn’t due to anything doctors
were prescribing.
In
1970 Linus Pauling’s book, Vitamin
C and The Common Cold, was published. From a statistical
standpoint, the daily dietary consumption of vitamin C remained
about the same over the past half century. But a significant number
of people began taking vitamin C pills to supplement their diet.
Pauling may have prolonged the lives of millions with the publication
of his book.
NIH
scientists today continue to maintain that taking more than 200
milligrams of vitamin C per day is worthless because any amount
beyond the 200 mg consumption point is excreted in the urine and
will not raise blood concentrations. [Biofactors 15:714, 2001]
But a recent analysis of nine pooled studies involving vitamin C
shows that those people who consume more than 700 milligrams per
day experience about a 30 percent reduction in cardiovascular disease
mortality compared to non-vitamin pill users. [Am J Clinical Nutrition
80:150820, 2004] Consumers can’t even find a pill today that
provides less than 500 milligrams of vitamin C. What do the consumers
and vitamin manufacturers know that the NIH refuses to acknowledge?
Next:
The Centers For Disease Control
Here’s
what happening this year’s flu season. There is a shortage of flu
vaccine due to contamination at a major vaccine manufacturing plant.
Instead of 100 million Americans getting a flu shot as planned,
only about 61 million doses are available. Despite concerns that
there might be a major flu epidemic without adequate vaccination,
the flu season is off to a very slow start. Here’s what the flu
charts look like without adequate vaccination.


The
flu chart is a bit misleading. For example, flu activity in Delaware,
the first state to be classified as having widespread flu problems,
is in the red zone because confirmed cases have been reported in
every county of the state. But the state has only three counties
and just six flu cases in all.
It
turns out this year’s prevalent flu strain, A-Wellington, is not
included in this year’s flu shot. The 2004-05 version of the flu
vaccine is about 2/3rds less effective in activating antibodies
against A-Wellington than it is against last year’s A-Fujian strain.
Flu vaccines confer some protection against viruses if they are
similar and the A-Fujian and A-Wellington are both H3N2 types of
influenza viruses. However, a study showed that last year’s flu
shots were only effective in 5 of 10 healthy adults and only 4 of
10 high-risk adults. Americans are doing far better this year, so
far, without much help from the CDC.
Now
for the FDA
If
you think the list of unsafe drugs is limited to what Dr. David
Graham revealed in Congress, five more drugs in addition to Vioxx
(Bextra, Accutane, Crestor, Meridia and Serevent), you had better
think twice. There are more drugs than these that are unsafe. If
you or your loved ones take prescription drugs, you need to know
which ones are unsafe from an unbiased source (not the FDA).
Ralph
Nader’s Public Citizen Group has been publishing a list of "do
not use" drugs for some time now and has a good track record
at predicting which approved drugs will be recalled two years before
they are actually withdrawn. Worst Pills, Best Pills is a
monthly newsletter available electronically through Public
Citizen’s Web site. There are 100,000 deaths a year in the United
States from adverse reactions from properly-used medications, and
nearly 1.5 million people are injured so seriously by adverse drug
reactions that they require hospitalization. Citizens can subscribe
to WorstPills.org for
a $15 fee, which includes a monthly newsletter with additional electronic
updates and news on dangerous prescription drugs.
For
example, Public Citizen reports that the rate of kidney failure
or damage among patients taking the cholesterol drug Crestor is
75 times higher than in patients taking all other statin drugs.
Public Citizen has renewed its call for the drug to be taken off
the market. Officials for the manufacturer of Crestor have been
quoted as saying: "We have been assured today at senior levels
in the FDA that there is no concern in relation to Crestor's safety."
That’s what was said about Vioxx.
Dr.
Sandra Kweder, deputy director at the Office of New Drugs at the
FDA, said that she did not agree with Graham’s assessment with the
risk posed by the five drugs singled out by Graham. Kweder maintains
the FDA’s drug review process is the "gold standard" for
the industry, but after Graham disclosed his list of drugs that
pose an avoidable increased risk to the news media, the FDA took
action to tighten controls on one of them (Accutane). It’s an admission
the FDA is covering for the drug manufacturers. The $300 million
user fees drug companies provide the FDA is being used to protect
the drug companies, not consumers.
We
can’t forget, while people were needlessly dying from the use of
Vioxx, the FDA took Dr. Graham to task for violating procedural
guidelines by airing his data to the British Medical Journal, where
the world could inspect the data the FDA had been hiding. In November
of 1996 Merck scientists had hypothesized that patients taking Vioxx
would have higher rates of heart disease compared to taking aspirin
and by 1998 they knew that Vioxx disabled one of the body’s defenses
against the clumping of blood platelets in arteries. Graham said
that before the FDA approved Vioxx, Merck performed a study that
found nearly a sevenfold increase in heart attack risk with low
doses of Vioxx. A change in the Vioxx label took 18 months to gain
approval, and it was not categorized as a "warning." Dr. Graham
had been fighting inside the FDA for some time before he skipped
around procedural guidelines and disclosed what was going on inside
the FDA.
The
same people are still in charge at the FDA today. Nobody has been
fired. In the mid-1990s only 2 percent of new drugs were approved
by the FDA. Today 68 percent of new drugs are approved in the United
States. Safeguards have been dismantled. The time it takes to get
a drug approved has been shortened, but drug costs remain high,
despite the fact that the pharmaceutical companies continue to maintain
their R & D costs are what drive up consumer prices for drugs.
Steven
Galson, MD, acting director of the FDA's Center for Drug Evaluation
and Research, said Graham's congressional testimony "does not
reflect the views of the agency." In fact, when Dr. Graham said
the country is "virtually defenseless" against
a repeat of the Vioxx fiasco, Galson immediately rejected that,
saying it had "no basis in fact." The voluntary
Merck recall throws Galson’s defense to the wind and now shames
the entire FDA.
What
you can conclude from this report is that government health agencies
are tainted. Their public health pronouncements are to be disregarded
or scrutinized carefully before altering any personal health regimens.
December
13, 2004
Bill
Sardi [send
him mail] is
a consumer advocate and health journalist, writing from San Dimas,
California. He offers a free downloadable book, The Collapse of
Conventional Medicine, at his
website.
Copyright
© 2004 Bill Sardi Word of Knowledge Agency, San Dimas, California.
Not intended for commercial use or posting on other websites. Permission
to reprint should be obtained from
the author.
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