Big Pharma Player gets NO from FDA on Proposed Drug

Merck is told NO on it's application for the experimental drug MK-0524A. Another government agency also gave a NO on Merck's proposed trade name for the product, Cordaptive. Merck says it will continue to press on to get the drug approved and file for a different trade name.

Now this is two strikes. The third strike already exists but is ignored by Big Pharma because it clings tightly to the cash cow category of unnecessary cholesterol lowering drugs.

Cholesterol lowering is a category designed to allow for the sale of these drugs, many taken off the market because of deaths, and disliked by patients because of the untoward side effects.

Ultimately, the drugs do little to protect your health, lead to cancer, Alzheimer's, liver failure, kidney failure, muscle wasting, cardiovascular problems and numerous other side effects.

What seems so strange is that this proposed drug contains niacin, or vitamin B3, known to reduce cholesterol. Some people do not like the 'flushing' side effect of B3, but this is a way to let you know the vitamin is working. Niacinamide is non-flushing B3, but it take a longer time to be effective.

Some say the flushing can be counteracted with an aspirin, but I would not encourage increasing the use of aspirin because it has other problems. And besides, why mask the positive effects of B3.

The compound Merck wants to combine with B3, to "offset the side effects of niacin", is laropiprant.

Searching around for information about laropiprant I came up with its chemistry on the AMA web site.

It is interesting to note that lapopriant uses a THERAPEUTIC CLAIM of treating atherosclerosis, dyslipidemia, and related conditions when administered with niacin. And I can't seem to find what it does alone.

But the kicker here is its another fluoride compound with the following chemical names -

1. Cyclopent[b]indole-3-acetic acid, 4-[(4-chlorophenyl)methyl]-7-fluoro-1,2,3,4-tetrahydro-5-(methylsulfonyl)-, (3R)-
2. (-)-[(3R)-4-(4-chlorobenzyl)-7-fluoro-5-(methylsulfonyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl]acetic acid.

Remember Baychol? That was a fluoride based anti-cholesterol drug removed from the market.

And look at the problems with fluoride based drugs in other categories like antibiotics, antidepressants and osteoporosis drugs.

Why would you want another round?

But Merck has other ideas.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, president of Merck Research Laboratories.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol," he said in a statement.

"We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world."

Perhaps you might want to have other plans too, and one should be to stay away from this and other cholesterol lowering drugs.