Misleading Claims For - Popular Heatburn/Ulcer Drug

Healthfacts, August, 2000 by Maryann Napoli

Last month, the Food and Drug Administration sent a warning letter to AstraZeneca. The pharmaceutical giant is accused of numerous misleading statements in some of the promotional materials and advertising for Prilosec, the top-selling prescription medication worldwide. This is the second warning to AstraZeneca in the last six months; the first involved failure to mention Prilosecs major side effects and contraindications in broadcast advertising.

Prilosec has been approved by the FDA for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD). Yet some of the promotional materials convey the idea that Prilosec is an appropriate treatment for ordinary heartburn. The FDAs warning letter describes "heartburn related to GERD as heartburn that occurs two or more days a week and persists despite diet or treatment."

Other appropriate indications for Prilosec treatment include "erosive esophagitis, maintenance of healed erosive esophagitis, active duodenal ulcer, active benign gastric ulcer, pathological hypersecretory conditions and in combination with clarithromycin and amoxicillin or with clarithromycin for Helicobacter pylori-associated duodenal ulcer disease." These indications can be found in the fine print of the ads directed at doctors and consumers; what youll notice first, however, is the banner headline proclaiming: Relief beyond belief.

Some of the violations found in AstraZenecas promotion of Prilosec include:

-no basis for claims of efficacy superior to its competitor drug, Prevacid;

-omission of nausea as a common side effect of Prilosec;

-unsupportable suggestion that increasing the dose of Prilosec will increase efficacy of Prilosec for erosive esophagitis or duodenal ulcers;

-lack of fair balance in presenting the risk information.

The FDA has warned AstraZeneca to immediately stop further use of materials that contained these misleading statements. The agency is charged with monitoring drug company advertising, promotional materials, and even the verbal statements made by salesmen at medical conferences. Since the start of the year 2000, the FDA has sent over 50 warning letters to various pharmaceutical companies. Unfortunately, no financial penalty is incurred by a company found to be disseminating misinformation.

Prilosec, which is sold as Losec outside the U.S., goes off patent next year. This means that other drug companies can compete by marketing less costly generic equivalents. At least thats what is supposed to happen; yet a recent New York Times (7/23/00) investigative report showed how some pharmaceutical companies conspire to keep low-cost drugs off the market.The focus of the report was Abbott Laboratories, the manufacturer of Hytrin, a top selling prescription drug for hypertension and the symptoms of an enlarged prostate. In 1998 Abbott struck a deal with two drug companies who had wanted to market a less expensive generic version of Hytrin. Abbott would pay $2-4 million a month to these two drug companies not to market a generic competitor. An anti-trust investigation stopped the deal a year later, but it made sense from Abbotts vantage point--Hytrin had been earning the company a half a billion dollars a year. The two drug companies who agreed to the settlement were Zenith Goldline Pharmaceuticals and Geneva Pharmaceuticals.

AstraZeneca, producers of Prilosec, was named in The New York Times report as guilty of a similar settlement regarding tamoxifen, its top-selling anti-breast cancer drug whose patent will soon expire.

Resource

All warning letters to drug companies are listed on the FDAs Web site (fda.gov/cder/warn/warn2000).