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FDA Panel Recommends Crestor For Healthy People

Posted by Jane Akre
Thursday, December 17, 2009 12:16 PM EST
Category: Major Medical
Tags: Diabetes, Crestor, Statin, Heart Attack, Jupiter Study

Crestor should be given to healthy people says an FDA panel.

Giving Drugs To The Healthy?

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IMAGE SOURCE:© iStockphoto/ streaming blood/ author: Eraxion

In seems incongruous - giving a medication to people who are healthy and not considered “at risk” for any disease.

A panel of the Food and Drug Administration (FDA) has voted to recommend that the cholesterol-lowering drug, Crestor, be approved for people who have inflammation.

This includes patients with no history of heart disease, but who may have an inflammatory biomarker C-reactive protein.

The panel voted 12-4 after a study showed that rosuvastatin, a potent statin known commercially as Crestor, showed promising results in lowering stroke, heart attack, hospitalization, and death over a placebo.

But there was a statistically significant increase, 27 percent, higher rate of developing diabetes among the group taking Crestor.

Also the study showed that 13 patients died from gastrointestinal disorders among the Crestor group. 18 patients reported confusion out of the same group.

The FDA has issued warnings in the past about Crestor and muscle damage.

The panel recommends that users of Crestor be monitored for diabetes but that the benefit outweighs the risk. Drug maker,AstraZeneca, should also “carefully define the target population in marketing materials,” the panel said.

Controversial Decision

Not everyone in the medical community is onboard with the recommendation.

Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic tells ABC News, “If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions,”

But others believe the recommendation should be followed, especially if patients are 50 or older for men, 60 or older for women and have LDL cholesterol less than 130 mg/dL, triglycerides of less than 500 mg/L, or if the patient has high blood levels of the inflammation marker, C-reactive protein (CRP).

Cardiologist, Dr. Christopher Cannon of Brigham and Women's Hospital in Boston, tells ABC News this is “outstanding news for people who are at risk but who would not previously known it. The treatment can reduce almost in half their risk of a first heart attack or other cardiac event," he said.

ABC also talked to family care doctors who agree that this is bad patient care, among them, Dr. Michael Good of ProHealth Physicians in Middletown, Conn.

"We know that giving statins to any population will lower their heart attack risk, and there are some in the cardiology community who feel that 'we should put it in the water.' However, unlike fluoride, which we do put in the water, statins have considerable side effects and risks. About one in 10 patients experience muscle pain and weakness, some have liver function changes and the statins as a group have many, many drug interactions."

AstraZeneca Study Basis of Recommendation

While the FDA is not required to follow the recommendation of an expert panel, it often does. This would mark the first time a prescription drug, normally used to lower dangerously high levels of bad cholesterol (LDL) among those “at risk” for suffering a heart attack or stroke, be approved for the prevention of heart attack in healthy people.

The JUPITER study of almost 18,000 men and women, which the panel looked at to make its recommendation, was sponsored by Astra Zeneca (AZ), the company that makes Crestor.

The drug was the third-best selling product for AZ last year with sales of $3.6 billion and has been taking shares away from competitor, Lipitor, reports AP. #


5 Comments

Anonymous User
Posted by Paul
Thursday, December 17, 2009 5:30 PM EST

When Uffe Ravnskov, MD PhD actually went back and looked at the peer-reviewed medical literature he found 38 cohort studies where people with higher cholesterol on average lived longer and no published studies showing the converse. Not a bad end-point to look at. Of course, this still leaves out the whole issue of statin side effects. Weren't they saying just a couple weeks back that statins cured swine flu? Now they want to give them to healthy people with normal cholesterol. This is embarrassing, just creepy drug pushers. 20 Billion in yearly sales though. If you care to read up on cholesterol and overall mortality there is an introductory write-up here LINK

Anonymous User
Posted by whatzaname
Thursday, December 17, 2009 6:24 PM EST

Sure, I trust Big Pharma to do what's best for the American people. If they say we all need to be on multiple prescriptions I'm sure its because its what's best for us....not just what makes them even wealthier. The FDA is their bought-and-paid-for stamp of approval, and "the media" their bought-and-paid-for mouthpiece.

Posted by nyscof
Friday, December 18, 2009 8:16 AM EST

Actually, adding fluoride into water supplies is not benign as most believe. Modern science shows that ingested fluoride confers no benefits and that dentists promoting fluoridation are still unaware of this (see LINK )

After 60+ years of water fluoridation, our food and beverage supply is almost totally contaminated with fluoride resulting in our children getting fluoride overdosed. The CDC reports that up to 48% of US school children sport dental fluorosis - white spotted, yellow, brown and/or pitted enamel.

At the least, fluorosis causes low self esteem studies have shown. At its worst dental fluorosis can be a sign that fluoride has also damaged the bones, studies show.

Fluoridation is based on very poor science and promoted with slick PR and appeal to authority. Fluoride is neither a nutrient nor essential to healthy teeth. This drug and any other drug should never be given to everyone whether they need it or not, and without monitoring for side effects or the synergistic effects and without knowledge of an individuals total fluoride intake which can only be measured using the USDA's fluoride in foods database..

Anonymous User
Posted by carol
Monday, December 21, 2009 3:16 PM EST

If something is not broken WHY Fix it!!

They're trying to create more problems in healthy people. This is ludicrous. They should recommend healthy spices instead like cinnamon, fenugreek and ginger. However, they can't make a big profit this way.

It's time for patients to say NO to drug pushers!!

Anonymous User
Posted by carol
Monday, December 21, 2009 3:16 PM EST

If something is not broken WHY Fix it!!

They're trying to create more problems in healthy people. This is ludicrous. They should recommend healthy spices instead like cinnamon, fenugreek and ginger. However, they can't make a big profit this way.

It's time for patients to say NO to drug pushers!!

Comments for this article are closed.

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