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Does the FDA Hide Negative Drug Study Results?

By: Mark Hyman MD

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, 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.

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/

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