Feature article from the March, 2003 Newsletter

The Newest Prescription Drug -
A Lot More Expensive, But Is It Actually Better?

If you watch television or listen to the radio, you cannot have escaped the snowstorm of ads for two new prescription medications: Nexium and Clarinex. Nexium is an antacid being marketed as a replacement for Prilosec, and Clarinex is an antihistamine being marketed to replace Claritin.

Why is Nexium being offered in place of Prilosec? Because it's more effective, or maybe safer? Or is it because the patent on Prilosec is about to expire, making it possible for generic equivalents to be offered at a fraction of Nexium's price?

Prilosec's manufacturer is fighting to circumvent the expiration of the patent on Prilosec, by invoking secondary patents that will not expire for another five years. If Nexium is better, why is the company so anxious to continue offering Prilosec as well?

In fact, trials of Nexium versus Prilosec did not show Nexium to be significantly superior, and some trials showed no difference between the two. By the way, those trials were conducted in Europe, because in the U.S., drug companies do not have to show that a new drug is more effective than its predecessor. They have only to show that it's more effective than a placebo (an inert substance disguised to resemble the medication). So instead of spending money on expensive trials that might produce unwanted results, the drug companies spend money on steamroller advertising campaigns for the new drug, realizing that most people, and many doctors, will take "new" to mean "improved".

You should also be aware that in the United States, the purportedly independent companies that test new drugs, are hired and paid by the drugs' manufacturers.

The above considerations apply also to the new product Clarinex and its predecessor Claritin whose patent will expire this year.

"It looks awfully like we have versions of prior products that, while they may hold some small advantage for a very small number of patients, are not that much better," said Steven Findlay, director of research for the National Institute for Health Care Management, a non-profit organization in Washington, D.C., that studies health-care issues.

Are there some new medications that are in fact major improvements? Of course. But as long as there is no requirement for comparison testing, and as long as the testers are in the employ of the people whose products they are evaluating, you and I will have a very difficult time distinguishing between facts and unsupported hype. Maybe a good rule of thumb is: The more intense the advertising, the more likely it is that the new product is no better than the old.

W. A. Shapiro

• For a summary of the trials evidence and registered data on Naxium, see:
        ww.centerwatch.com/patient/drugs/dru665.html
• For an article on the Clarinex advertising blitz, see:
        http://www.ohio.com/mld/ohio/news/nation/3299821.htm?template=contentModules/printstory.jsp



3/31/2003 1920