Does the FDA Hide Negative Drug Study?

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Article Title:

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Does the FDA Hide Negative Drug Study?

Article Description:

====================

Think the Food and Drug Administration (FDA) is here to protect

you? It isn't. Think your doctor makes decisions about your

health based on medical science? Not so fast. Truth is, half of

medical evidence is hidden from your doctors. And the half

that's hidden is the half that shows drugs don't work.

Additional Article Information:

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Distribution Date and Time: 2008-03-11 11:12:00

Written By: Mark Hyman, M.D.

Copyright: 2008

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Does the FDA Hide Negative Drug Study?

Copyright © 2008 Mark Hyman, M.D.

UltraWellness

http://www.ultrawellness.com/blog/

Think the Food and Drug Administration (FDA) is here to protect

you?

It isn't.

Think your doctor makes decisions about your health based on

medical science?

Not so fast.

Truth is, half of medical evidence is hidden from your doctors.

And the half that's hidden is the half that shows drugs don't

work.

Today I'd like to tell you about some recent news that

highlights why we need more accurate, more accessible databases

for drug information – and why our government just can't be

trusted to make objective decisions about your medications.

First, let me explain how our FDA works.

When a drug company designs and performs a study, it has to

submit all of its results to the FDA.

But this often doesn't happen.

Instead, the pharmaceutical companies submit only the data they

want to get published to medical journals – positive data, of

course.

They hide negative studies from the scientific community – and

from you.

The FDA didn't release this information until 2004, when all the

major scientific journals refused to publish any data from any

drug study that did not list the results of all trials, positive

or negative, in a central database.

The problem? This database is hard to find and search.

Your doctor probably doesn't have time to read medical journals,

never mind search a database. So he or she relies on the bits of

information delivered by drug reps – not the best way to get an

objective opinion!

A Bitter Pill to Swallow

These problems were made even more apparent by the recent news

about Zetia.

Zetia is a new drug that lowers cholesterol by a different

mechanism than statin drugs like Lipitor and Zocor.

Most doctors wrongly believe that cholesterol causes heart

attacks – even though half of all people who have heart attacks

have normal cholesterol.

Cholesterol-lowering statins lower cholesterol, and appear to

reduce heart attacks. But I believe – and a study published in

the January 6, 2005, issue of the New England Journal of Medicine

supports this – that they reduce heart attacks by reducing

inflammation, not cholesterol.

Nevertheless, the FDA approved Zetia without any proof that it

lowered heart attacks or reduced the progression of heart

disease. The drug was approved only because it lowered

cholesterol.

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.

And why should they? The drug was making them $14 million a day

in profits.

But the FDA had the negative data on Zetia – and it didn't speak

up.

The data that was withheld proved that Zetia lowered cholesterol

– but led to MORE heart disease!

That suggests that high cholesterol may not be a disease and may

or may not be related to heart attacks.

Another new cholesterol drug, torcetrapib, was pulled from the

pipeline in December 2006 because it caused more heart attacks

and strokes.

A Voice for Change

This recent information shows us that our research and approval

system is flawed in several ways.

First, drug companies fund most of the research in the world.

That means that other therapies that may work better – including

diet and lifestyle or nutritional therapies – often don't get

enough funding.

Second, the FDA helps drug companies by suppressing and hiding

negative studies on drugs.

Finally, doctors, patients, and the media believe they have the

whole truth – but we don't. Often, we don't know the truth

until it is too late – like with Zetia, Premarin, and Vioxx.

This makes it very difficult for consumers to get the best

treatments for their health and the whole truth about drugs.

But together, we can work to change things for the better.

Here's how.

1. Follow the money. Be suspicious of studies funded by drug

companies.

2. Contact your congressperson or senator and demand better

legislation. We should have 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 (the basis of

UltraWellness) 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.

REFERENCES:

Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee

F, Haug C, Hébert 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.

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.

Kastelein JJ, van Leuven SI, Burgess L, 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.

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Mark Hyman, MD is a pioneer in functional medicine, practicing

physician and best-selling author. A sneak preview of his book

" The UltraSimple Diet " is available. See The UltraWellness Blog

for more on Medical Industrial Complex:

http://www.ultrawellness.com/blog/