Word: pravachol
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...three otherwise healthy cardiologists whether they are taking a cholesterol-lowering drug, and chances are good that at least two of them will reply with a hearty "You bet." Their prescription of choice: one of a group of drugs called statins--marketed under such names as Lipitor, Pravachol and Zocor--that have been proved to reduce deaths among heart-attack survivors by more than 40% over five years. In effect, the doctors are taking a highly educated gamble that the medications, currently taken by more than 10 million Americans, will be just as effective in those who do not necessarily...
...statins were approved in the U.S. in 1987, they didn't really take off until 1994, when researchers in Scandinavia proved that simvastatin (brand name Zocor) could significantly decrease a heart patient's risk of dying from a second heart attack. After investigators showed that both simvastatin and pravastatin (Pravachol) could cut the number of first heart attacks among those with high cholesterol, doctors assumed that all statins could do likewise...
...same active ingredient found in lovastatin (Mevacor). The FDA tried to ban the supplement's sale in the U.S., but the action has become the subject of a lengthy court process. The controversy hasn't stopped Merck, which manufactures Mevacor and Zocor, and Bristol-Myers Squibb, which produces Pravachol, from arguing that they should be allowed to sell their pharmaceutical-grade products at similarly low doses to the general public...
...debate begins in earnest this week, when the FDA conducts hearings on requests by Merck & Co., maker of Mevacor, and Bristol-Myers Squibb Co., manufacturer of Pravachol, to sell lower-dose versions of their cholesterol-lowering products over the counter (OTC). If the FDA approves the switch, it may unleash a flood of similar requests from other drugmakers...
Merck and Bristol-Myers Squibb say they are pushing for OTC status for their products to make them more widely and cheaply available. But analysts note that Merck's patent on Mevacor expires next year. And while Bristol-Myers Squibb's patent on Pravachol runs to 2005, generic versions of Mevacor will surely cut into Pravachol's sales, justifying Bristol-Myers' push for OTC too. An added benefit: a switch could give the maker exclusive selling rights on the drug for three more years. That's why medicines like the hair-loss treatment Rogaine (owned by Pharmacia Corp...