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05/05/13 1:05 PM

#5692 RE: Biobillionair #5639

This is another pure money grab attempt by BP to create useless generic components to create a new FDA approved drug in attempts to keep money rolling in despite no evidence the new drug actually does anything helpful:

Although the combination drug, to be called Liptruzet, was shown in a clinical trial to reduce LDL cholesterol more than patients who took Lipitor alone, the company said Liptruzet did not reduce patients’ chances of developing heart disease. That fact troubled some cardiologists, who questioned why it was approved.

“This is extremely surprising and disturbing,” said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Cardiologists have long questioned the value of Zetia and Vytorin, which combined Zetia with an older statin, Zocor. They had been on the market for a decade, but had not been shown to reduce the risk of heart disease.

A clinical trial of more than 18,000 patients is assessing whether Vytorin significantly reduces heart attacks, strokes and heart-related deaths and is expected to conclude in 2014. In March, an independent monitoring board let the trial continue, suggesting that no significant safety concerns had come up. Still, Dr. Nissen said he was skeptical that the trial would show that the drugs were effective.

Morgan Liscinsky, an F.D.A. spokeswoman, said high levels of LDL cholesterol were a known risk factor for heart disease. “Liptruzet is a combination of two currently marketed drugs that effectively lower elevated levels of LDL cholesterol,” she said. The F.D.A. rejected Merck’s application for the drug last year, and the company said at the time that the agency requested more information.


Note how that "FDA spokeswoman" blindly repeats the commonly held opinion that LDL = CV risk, while no data exists that shows simply lowering LDL actually reduces CV events? They're complicit in this scam, which ultimately increases the health costs for our nation - it's a disgrace.