Will Statins Become OTC Drugs in the U.S.?

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>http:/ /www.mercola.com/2005/jan/15/statins_otc.htm

>

>Will Statins Become OTC Drugs in the U.S.?

>

>Drug company Merck is seeking approval from the FDA to sell their

>cholesterol drug Mevacor over the counter. The attempt marks the

>company's second try at selling their drug without a prescription.

>

>As it stands, only allergy pills and stomach acid remedies have made

>the switch from prescription to over-the-counter status. The

>difference is that cholesterol-lowering drugs, unlike the other two

>categories, are geared toward a chronic condition that has no symptoms.

>

>This is one reason why doctors who believe over-the-counter drugs

>should be used for short-term conditions that patients can diagnose

>themselves are highly skeptical of the potential switch.

>

>Further, cholesterol drugs, which make up the top-selling category of

>drugs in the United States (they brought in $14 billion in sales in

>2003), are known to raise the risk of liver, kidney and muscle problems.

>

>Previously, the FDA recommended against allowing Mevacor to be sold

>without a prescription, saying they needed more information about

>whether consumers would use the drug in the right manner. Since then,

>Merck reportedly conducted a study showing that consumers are able to

>make the correct decisions regarding the drug.

>

>If Mevacor is granted over-the-counter status:

>

> * Merck has prepared in-store materials to educate consumers on

>whether or not they should take the drug

> * Consumers would need a blood test to identify their cholesterol

>level

> * Consumers would need to learn the risk factors for heart disease

> * The drug would be marketed to people with at least one risk

>factor for heart disease and a " bad " LDL cholesterol level in the 130

>to 170 range

> * The drug, in a 20-milligram dose, would cost about $1 a day

>

>Bristol-Myers Squibb also intends to seek over-the-counter status for

>its cholesterol drug Pravachol.

>

>USA Today December 28, 2004

>

>Dr. Mercola's Comment:

>

>Back in 2003, there was talk in the business press that drugmakers

>Bristol Myers-Squibb and Merck would file separate requests with the

>FDA to sell their statin drugs, Pravachol and Mevacor respectively,

>over the counter (OTC). That intention has finally become a reality,

>with Merck's application being considered, for a second time, by an

>FDA advisory committee and Bristol Myers-Squibb announcing it will

>seek the same status for Pravachol.

>

>British regulators approved another statin drug, Zocor, for OTC status

>in August 2004.

>

>If you noticed, there was only ONE major concern voiced in the piece:

>The one expert who smartly pointed out such deregulation is a bad idea

>because OTC drugs are meant to treat short-term conditions, and high

>cholesterol " has none of those things. "

>

>I couldn't agree more with that comment, but the problem is much more

>complex than that.

>

>Folks, the bottom line is that statin drugs are truly dangerous--I

>find it hard to believe that many would take them if they knew the

> " secrets " of how to truly optimize their cholesterol and, at the same

>time, improve their health and reduce their risk of cancer.

>

>In fact, there are only a very small handful of people who I would

>recommend them to--far less than one in 100. Nearly everyone can

>normalize their cholesterol levels by eliminating grains and sugars,

>exercising and retooling your diet based on your body's unique

>metabolic type.

>

>

>There are only a handful of people with genetic issues who I feel

>benefit from taking statin drugs, and their cholesterol levels are

>typically 350 or higher.

>

>Related Articles:

>

> High Cholesterol Drug Mevacor Approved for Kids -- But Don't Be Fooled

>

> The Truth About Crestor: Is Crestor Dangerous And, if so, Why?

>

> Crestor and Other Statins: Are They Really Worth the Risk?

>

> Statins, Calcium a Deadly Mix

>

> Cholesterol Drugs: How Expensive Is Too Expensive?

>

> Cholesterol Drugs Actually Cause Heart Disease

>

>

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