Me-too drugs

Source: http://stanmed.stanford.edu/2005summer/drugs-metoo.html

It’s expensive to produce an innovative drug. On average, the bill runs to more than $400 million. So drug companies often take a less costly route to create a new product. They chemically rejigger an oldie but goodie, craft a new name, mount a massive advertising campaign and sell the retread as the latest innovative breakthrough.

This strategy has shown great success for turning profits. Nexium, a “me-too” drug for stomach acid, has earned $3.9 billion for its maker, AstraZeneca, since it went on the market in 2001. The U.S. Food and Drug Administration classified three-fourths of the 119 drugs it approved last year as similar to existing ones in chemical makeup or therapeutic value.

Though there are hints that consumers are more aware of drug marketing ploys, many fall for the sales hype, despite an absence of evidence that the new drug is better than the tried-and-true remedy. In 2003, the industry spent $25.3 billion marketing drugs, according to the industry trade group Pharmaceutical Researchers and Manufacurers of America.

Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.

Is Nexium better? So far, there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.

“Newer isn’t always better, when it comes to drugs,” says Stafford, associate professor of medicine with the Stanford Prevention Research Center.

“The FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs,” Stafford says. “I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market.”