Me-too drugs

Sometimes they're just the same old, same old


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.”

The findings of an annual survey on direct-to-consumer advertising released in April suggest consumers are becoming less gullible. The national Rodale survey, which polled 1,504 adults from Dec. 28 to Jan. 12, found that among those who asked their doctors about an advertised drug, the portion asking directly for the drug fell to 21 percent — 5 percentage points lower than last year. The poll’s analysts interpret this drop as evidence that consumers are paying less attention to the likely benefits of advertised drugs and more to the potential risks.

Experts also believe consumers are beginning to take steps to weed through the marketing mumbo jumbo and find the most effective drug at the best price. The new drug information Web site — — launched in December by Consumers Union racks up between 2,000 and 5,000 visits a day, according to Gail Shearer, the program’s project director.

The site compares the effectiveness and cost of drugs for prevalent health problems including high blood pressure, high cholesterol, pain and depression. The underlying source of analysis for the site is the Drug Effectiveness Review Project, a highly-regarded, evidence-based review of clinical effectiveness carried out by Oregon Health and Science University. Twelve states use this same data to choose which drugs to make available in their markets.

But in the end, the real question is about pharmaceutical innovation. While me-toos fill the development pipeline, the benefits flow largely to the haves of this world. Few resources go toward drugs targeting diseases that primarily affect developing nations. So, what about the rest of the world?


Comments? Contact Stanford Medicine at

 Back To Contents