The Mudcat Café TM
Thread #145318   Message #3361049
Posted By: Q (Frank Staplin)
08-Jun-12 - 05:51 PM
Thread Name: BS: Lipitor, the multi-billion dollar drug
Subject: BS: Lipitor, the multi-billion dollar drug
This thread is started in answer to false information about this drug posted in mudcat. Its development is a success story for scientists working for the drug companies.

Dr. Akira Endo, working for the drug company Sankyo, set out to create a cholesterol-lowering drug. He searched for a compound that inhibited the enzyme HMG-CoA. He identified mevastatin in 1971, the first cholesterol fighting drug.

Merck, was doing research to the same end. Dr. Vageros and Merck scientists duplicated Endo's work, and synthesized a new statin, lovastatin in 1978, and began to work towards FDA approval, and got it. Doctors prescribed statins to reduce cholesterol and reduce heart attack. Another Merck-approved product, Simvastatin, later Zocar, showed well in tests, and by 1994, it and Merck's Mevacor were both billion-dollar winners.

Sankyo and Bristol Myers Squibb joined to market a competitor, Pravachol.

Back in 1982, Bruce Roth, a post-doctoral fellow at Rochester University, synthesized a product close to Endo's and attracted the attention of Warner Lambert. Roth signed on with them, and headed an 18-scientist atherosclerosis group.
New statins were synthesized, but it looked like Warner Lambert were losing out. Then Ronald Creswell, head of their labs, convinced management to test their Lipitor with humans in clinical trials.
Pfizer joined with Lambert in the tests and they marketed Lipitor in 1996.

In a head-to-head trial published in 1996, Lipitor, Pravachol, Lescol (Novartis), Zocar and Mevacor results were shown graphically. Lipitor started at a higher point, and swung upward more rapidly.
Lipitor got FDA approval in 1997 and the media blitz started. They also undercut Merck's price.
Pfizer acquired Warner Lambert for $90 billion in 1999 and gained control of Lipitor.

Roth is now a manager, and handles a large part of Pfizer's over $5 billion a year research budget.

The global market for statins hit $24 billion in 2007, and continued to grow. Income from Lipitor is approaching $10 billion per year.

Statins have drawbacks, effects such as weakening of heart muscles, and require careful medical supervision of patients using them.