Seniors protest drugmaker's tactics for protecting its GI drug

More than 200 Gray Panthers, a group of senior activists, and their supporters staged a town hall-style meeting in San Francisco to condemn pharmaceutical manufacturers for their sales and patent policies. A quarter of the audience took the protest to the sidewalk in front of Digestive Disease Week, the annual scientific meeting of four gastroenterological medical groups. Their target was AstraZeneca.

"Health care in America is in crisis, and pharmaceutical companies are a major contributor to that crisis," Gray Panthers executive director Tim Fuller told the group. "We don't have a generic version of Prilosec [omeprazole, AstraZeneca] today because of lawsuits brought by AstraZeneca. Consumers have the right and the responsibility to hold drug companies accountable for their priorities."

The Gray Panthers are targeting AstraZeneca over the company's handling of Prilosec and its replacement product, Nexium (esomeprazole). The company, critics charge, is profiting unfairly and unethically by delaying the introduction of generic omeprazole with questionable legal tactics.

"AstraZeneca does not have the ability to determine the timing of generic products," countered company spokesman Jim Coyne. "Our efforts have been focused on patent protection."

The Gray Panthers don't agree. Fuller said AstraZeneca has wrung American patients out of $1.4 billion since October 2001. That's when the patent on Prilosec expired. Although generic manufacturer Andrx Corp., based in Fort Lauderdale, Fla., is ready to introduce generic omeprazole, patent infringement suits brought by AstraZeneca have effectively blocked release of the generic. Until a generic hits the market, Fuller added, AstraZeneca is earning $6.25 million daily from Prilosec. A generic version would immediately force prices down by 30%-50%. Multiple generic versions would cut the price of omeprazole to about 70% of brand-name levels, he said. Prilosec sales hit $3.7 billion in the United States in 2001.

The Gray Panthers aren't alone on the patent issue. Solidly pro-business publications such as Forbes magazine and the Wall Street Journal are giving front-page coverage to the trials and tribulations of AstraZeneca, Bristol-Myers Squib, and other drugmakers trying to protect blockbuster drugs from generic competition.

Lawsuits and other legal tactics that delay introduction of generic products have also become a hot topic in Washington. Federal Trade Commission chairman Timothy Muris has called for changes in the Waxman-Hatch Act. Provisions of the act allow drugmakers to obtain an automatic 30-month delay in the introduction of generic versions of brand-name drugs.

But zealous patent protection is just one complaint. AstraZeneca was also criticized for its aggressive marketing campaign to switch Prilosec patients to Nexium 40 mg. About 38% of Prilosec patients have switched to Nexium, according to industry research firm IMS Healthcare. Some 90% of patients who switched moved to the 40-mg formulation, which is not available in Prilosec.

Fuller said the switch has little or nothing to do with improved clinical efficacy of Nexium over Prilosec. He credits nonstop promotion to prescribers as well as a $50 million direct-to-consumer campaign touting a newer, stronger, more effective "purple pill." "This isn't good medicine," he charged, "it's good marketing. AstraZeneca is engaged in a campaign that misleads physicians as well as the public."

Pharmacist Candy Tsourounis agreed. "For the vast majority of patients, the 20-mg dose is sufficient," said the assistant clinical professor and action director of drug information analysis at the University of California San Francisco School of Pharmacy. "A few patients with severe GERD [gastroesophageal reflux disease] may need the higher dose, but AstraZeneca is pitching the higher dose as generally better for all patients. That is not necessarily the truth."

The drugmaker sees the data in a different light. "It's important to cut through the rhetoric," Coyne said. "Clearly, the data we report in the prescribing information show important improvement for Nexium over Prilosec for erosive esophagitis disease. Let's not inflame the issue."

The debate will continue, Fuller said, and pharmacists have already been promised a ringside seat. Another town hall meeting and another protest march are slated for the American Pharmaceutical Association meeting in New Orleans in March 2003.

Fred Gebhart

Fred Gebhart. Seniors protest drugmaker’s tactics for protecting its GI drug.

Drug Topics

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