FDA & Medical Doctors & Drugs

Your doctors think they make decisions based on
medical evidence.

But they don't!

In fact, half of medical evidence is hidden from
your doctors. And the half that's hidden is the
half that shows drugs don't work.

The bad news is that drug companies are not
policed by the Food and Drug Administration
(FDA) the way they should be. A drug should be
proven both effective and safe BEFORE it is
prescribed to millions of people.

Sadly, that often isn't the case.

Let me share with you two recent examples that
highlight the dangerous collusion between drug
companies and our government agency. They show
why the FDA should really stand for "Federal
Drug Aid."

First, we now know that the cholesterol-lowering
drug Zetia actually causes harm and leads to
faster progression of heart disease DESPITE
lowering cholesterol 58 percent when combined
with Zocor.

This challenges the belief that high cholesterol
causes heart attacks and shakes the $40 billion
dollar cholesterol drug industry at its
foundation.

Second, it's come to light that nearly all the
negative studies on antidepressants - that's
more than half of all studies on these drugs -
were never published, giving a false sense of
effectiveness of antidepressants to treat
depression.

Don't get me wrong.

I'm not telling you to blame your doctor.

Instead, blame deceptive scientific practices
and industry-protective government polices.

==> Let's talk a closer look at these findings
and their implications.


I once had a patient who worked in the drug
approval division of the FDA. She taught me a
very important lesson.

When a drug company designs and performs a
study, it has to be registered with the FDA and
ALL the results must be submitted to the FDA.

But it doesn't work that way.

Instead, the pharmaceutical companies ONLY
submit the data they want to get published to
medical journals.

That means that any negative studies are hidden
from the scientific community and from the
public.

And when drug studies are sponsored by drug
companies - as most are - they find positive
outcomes at 4 times the rate of independently
funded studies. This is also true for nutrition
studies funded by the food industry that show
the benefits of dairy or high-fructose corn
syrup.

The FDA does not release this information.

That was, it didn't until 2004 when all the
major scientific journals banded together and
refused to publish any data from any drug study
that did not list the results of all trials,
either positive or negative, in a central
database. (1)

Well, that sounds good - but listing obscure,
unpublished studies buried deep in a hard-to-
navigate public database run by the National
Institutes of Health is hardly visible public
disclosure.

Sure, the research studies are at least listed,
but try to find out the results.

After a few hours searching around on the
website clinicaltrials.gov, I gave up.

Last year, Congress passed legislation expanding
how much detail must be listed, but at the end
of the day, who even looks at that?

Most doctors don't even have time to read the
medical journals they receive. They get tiny
bits of information from drug reps, who come to
their office with free lunch and a sound bite
about their drug.

They get slightly more information from
researchers who are funded by pharmaceutical
companies and present their findings at
conferences sponsored by pharmaceutical
companies, using presentations prepared for them
by pharmaceutical companies.

Not exactly independent, evidence-based
medicine!

==> Now let's get back to the news about Zetia.

Zetia is a new drug that lowers cholesterol by a
different mechanism than statin drugs like
Lipitor and Zocor.

Why does this matter?

Well, doctors have been brainwashed to think
that cholesterol is the cause of heart attacks
even though half of all people who have heart
attacks have NORMAL cholesterol.

And it seemed like the statins, which lowered
cholesterol, actually reduced heart attacks.

Seems logical. If you lower cholesterol, you
reduce heart attacks, right?

No!

I believe that the reason statins lower risk is
NOT because they lower cholesterol, but because
they reduce inflammation.

In fact, studies by Dr. Paul Ridker of Harvard
show that the risk of heart attacks was only
reduced if inflammation was lowered along with
LDL cholesterol - but not if LDL cholesterol was
lowered alone. (2)

So then along comes a drug that can be combined
with statins to lower cholesterol even more.
Great idea?

Not really.

You see, the FDA approved Zetia without any
proof that it lowered heart attacks or reduced
the progression of heart disease. The drug was
approved solely on the basis that it lowered
cholesterol.

Yet Zetia was given to 5 million people - and
made the drug companies $5 billion a year.
That's almost $14 million a day!

And once Zetia was approved, its makers had no
incentive to prove that it actually did what it
was thought to do - lower heart attacks.

They dragged their feet doing the studies and
then released the negative data (which they did
only under pressure from news agencies and
Congress) after a long delay.

Wouldn't you drag your feet too if you were
making $14 million a day?

But the FDA had the negative data on Zetia - and
it didn't speak up.

The data that was withheld proved that Zetia did
not reduce heart attacks but actually INCREASED
fatty plaques in the arteries despite lowering
cholesterol.

Let that sink in for a moment.

That's right: Lowering cholesterol led to more
heart disease!

That turns our whole medical model upside down.
It shows us that high cholesterol is NOT a
disease and may or may not be related to heart
attacks.

Another recent study put another nail in the
coffin of the Cholesterol Myth.

A major new cholesterol drug, torcetrapib, was
pulled from the pipeline in December 2006
because despite lowering LDL cholesterol and
raising HDL cholesterol in 15,000 people, it
caused MORE heart attacks and strokes. (3)

This was to be the new cholesterol wonder drug.
Oops.

==> All this points to a big research mess that
is flawed in three ways.



First, what gets studied depends on who is
funding it.

Since drug companies fund most of the research
in the world, other therapies that work better -
such as diet and lifestyle or nutritional
therapies - never get enough funding.

Second, drug companies are aided by the FDA,
which suppresses, hides, and doesn't publish
negative studies on drugs, only positive ones.
This leads doctors to think they have all the
evidence when they don't.

Third, doctors, patients, and the media believe
they have the whole truth, often until it is too
late, like with Zetia or Premarin or Vioxx.

The evidence was there, but no one looked or
publicized it.

This makes it very difficult for consumers to
get the best treatments for their health and the
whole truth about drugs.

Here's my advice on how to make sense of things.

1. Follow the money. Look carefully at who
funded the study. Be suspicious if it was funded
by drug companies.

2. Call or email your congressperson or Senator
to demand better legislation providing an easy-
to-navigate database of all drug trials, with
consumer-friendly summaries of both published
AND unpublished data submitted to the FDA so you
can look up the drug you are prescribed and have
a balanced opinion.

3. Don't assume that drugs are the answer to
your health problems. Heart disease is NOT a
Lipitor deficiency but the result of your
lifestyle interacting with your genes.

4. Learn to ask the question "why?" - and search
for the answers. Dealing with lifestyle and
environmental factors almost always works better for
chronic illnesses. Drugs are there as a backup
only if needed.

So take a closer look at the information you've
been given about drugs. You might be surprised
by what you find.

Now I'd like to hear from you...

Were you aware of the studies I've mentioned
today?

Which of the steps here do you plan to follow?

What has you experience been with medications
compared to lifestyle measures?




REFERENCES:

(1) Laine C, Horton R, DeAngelis CD, Drazen JM,
Frizelle FA, Godlee F, Haug C, Hebert PC, Kotzin
S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van
der Weyden MB, Verheugt FW.Clinical trial
registration: looking back and moving ahead.
JAMA. 2007 Jul 4;298(1):93-4.

(2) Ridker PM, Cannon CP, Morrow D, Rifai N,
Rose LM, McCabe CH, Pfeffer MA, Braunwald E;
Pravastatin or Atorvastatin Evaluation and
Infection Therapy-Thrombolysis in Myocardial
Infarction 22 (PROVE IT-TIMI 22) Investigators.
C-reactive protein levels and outcomes after
statin therapy. N Engl J Med. 2005 Jan
6;352(1):20-8.

(3) Kastelein JJ, van Leuven SI, Burgess L,
Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH,
Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots
ML; RADIANCE 1 Investigators.Effect of
torcetrapib on carotid atherosclerosis in
familial hypercholesterolemia. N Engl J Med.
2007 Apr 19;356(16):1620-30.