The issue of advertising prescription drugs directly to consumers is at the heart of a lawsuit filed yesterday against the pharmaceutical giant AstraZeneca by a coalition of consumer activists representing labor, retired workers and the elderly.
The lawsuit, filed in a state court in Los Angeles, takes on a familiar target - the decision by AstraZeneca in 2001 to introduce one drug, Nexium, to replace another, Prilosec, as the patent protection for Prilosec was expiring.
The new element is the claim that the billions of dollars subsequently spent by AstraZeneca on advertising, promotions and other marketing persuaded consumers to shun much cheaper alternatives like generic drugs and Prilosec in its over-the-counter iteration by wrongfully presenting Nexium as more effective in treating acid reflux.
Directing ads for prescription drugs to consumers "is not wrong, because it's legal," Steve W. Berman of the Seattle law firm of Hagens Berman, which filed the lawsuit, said in a telephone interview. "What's wrong here is that it was deceptive.
"This is,'' he said, "a prime example of the abuse that has led to billions of dollars being spent unnecessarily by consumers."
A spokesman for AstraZeneca, Jim Coyne, based in Wilmington, Del., said the accusations were "simply not supported by the facts."
"With respect to the advertising, from the time of launch to the present day we've advertised Nexium based on the strength of the data we have," Mr. Coyne said. "All the statements we've made and continue to make about Nexium are supported by the data."
Nexium, approved three years ago by the Food and Drug Administration as a treatment for severe acid reflux disease, is AstraZeneca's best-selling drug and ranks No. 7 among all prescription drugs sold in the United States. The $257 million spent last year to promote Nexium to consumers, as estimated by Nielsen Monitor-Plus, ranked it first among all such drug advertising.
Campaigns aimed at consumers for Nexium, promoting the brand as the "purple pill," are created by Saatchi & Saatchi Healthcare in New York, part of the Publicis Healthcare Communications Group division of the Publicis Groupe. A spokeswoman for Publicis did not respond to a request for a comment.
The coalition filing the lawsuit on behalf of consumers is made up of the A.F.L.-C.I.O., the California Alliance for Retired Americans and the Congress of California Seniors. All three are among the 100 members of an organization called the Prescription Access Litigation Project, which litigates against what it considers to be the illegal price inflation of prescription drugs.
"As an organization, we don't have a position on direct-to-consumer drug advertising," Alex Sugerman-Brozan, director of the litigation project in Boston, said in a telephone interview. "Speaking personally, on balance I feel it's a negative."
Such advertising "can have a harmful effect when it convinces people to take a drug they don't really need," he added, "or to take an expensive brand-name drug when an over-the-counter or generic drug would be better."
In this instance, Mr. Sugerman-Brozan said, the ads and promotions for Nexium "caused millions of people to take a drug at inflated high prices" because the over-the-counter version of Prilosec can run "one-eighth the cost of prescription Nexium" and is no different from Nexium in its treatment of acid reflux.
The label for Nexium approved by the F.D.A. describes the results of four tests. In two tests, a 40-milligram dose of Nexium was described as healing patients more quickly than a 20-milligram dose of Prilosec; the two other tests were described as inconclusive.
"The truth," the lawsuit says, "is that there is no evidence that Nexium is superior, at standard doses, to Prilosec and other P.P.I.'s," using the initials for the class of drugs of their type, known as proton pump inhibitors.
Daniel J. Jaffe, executive vice president and the director head of the Washington office of the Association of National Advertisers, the trade organization for marketers, said he could not comment on specifics because he had not had a chance to read the papers filed in the lawsuit. Generally, Mr. Jaffe said, "there is no other area of advertising more heavily regulated and restricted" than prescription drug ads directed at consumers.
"The F.D.A. scrutinizes these ads, with very heavy penalties for any false and deceptive claims by the drug companies," Mr. Jaffe said, "and no matter what it says in an ad, no one can get access to these products unless they get a prescription from a doctor, who is making the final determination."
Mr. Jaffe said it was too soon to tell whether the lawsuit represented a new threat to direct-to-consumer advertising, which totaled an estimated $3.8 billion last year.
The lawsuit was filed in California, Mr. Berman, the plaintiffs' lawyer, said, because the state has laws covering unfair competition and false advertising that are considered favorable to consumers.
The lawsuit seeks no specific amount of damages. It asks for AstraZeneca to make "restitution and/or disgorgement of all unlawful or illegal profits" earned through selling Nexium as well as pay interest on those profits and cover the legal costs of the organizations bringing the lawsuit.
The lawsuit is the first time the A.F.L.-C.I.O. has been a part of the litigation project, according to Mr. Sugerman-Brozan, who called that a significant step in efforts to hold down health care costs by reducing the prices that union members pay for drugs and medicines.
Stuart Elliott, The New York Times. October 19, 2004.
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