Lexapro and Forest Laboratories...bad ethics

Just more revelations of drug company greed and market manipulation.

"A Drug Maker’s Strategy Revealed"

by

Gardiner Harris

September 2nd, 2009

The New York Times

The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost.

No drug better demonstrates the industry’s salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. And a document quietly made public recently by the Senate’s Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller.

The document, “Lexapro Fiscal 2004 Marketing Plan,” is an outline of the many steps Forest used to make Lexapro a success. Because of concerns from Forest, the Senate committee released only 88 pages of the document, which may have originally run longer than 270 pages. “Confidential” is stamped on every page.

But those 88 pages make clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors’ pockets and food into their mouths.

Frank Murdolo, a Forest spokesman, said the company was “aware” that its marketing plan was circulating around the Senate.

“We’re aware of it but I can’t give you any other comment on it,” he said.

In February, federal prosecutors in Boston announced a civil lawsuit against Forest claiming that the company illegally marketed both Lexapro and a closely related antidepressant, Celexa, for use in children and paid kickbacks to doctors to induce them to prescribe the medicines to children.

It is illegal to pay doctors to prescribe certain medicines to their patients. It is not illegal to pay doctors to educate their colleagues about a medicine. In recent years, federal prosecutors have accused many drug makers of deliberately crossing that line.

Lexapro was the sixth drug in a class of medicines that includes Prozac, Paxil, Zoloft, Luvox and Celexa. Forest licensed Celexa from Lundbeck of Denmark and introduced the medicine into the United States in 1998. But because Celexa’s patent life was relatively short, the company quickly developed a new version of Celexa by tinkering with the molecule in a way that is standard in the industry. The company called the new medicine Lexapro and introduced it into the United States in 2002.

Forest’s executives and paid consultants have long implied that Lexapro is superior to Celexa and other antidepressants. But the Food and Drug Administration did not require Forest to test this theory in any statistically valid way. The F.D.A. views the two medicines as so interchangeable that the agency recently approved Lexapro’s use in depressed adolescents based in part on the results of a study Forest conducted using Celexa.

Lexapro had $2.3 billion in sales in 2008 even though generic versions of Celexa and every other drug in the class sell for a fraction of Lexapro’s price. For example, a month’s supply of 5-milligram tablets of Lexapro costs $87.99 at drugstore.com, compared to $14.99 for a month’s supply of a generic version of Prozac. Forest has recently been raising the price of Lexapro to make up for a decline in its use.

Many doctors say they believe that Lexapro is the best antidepressant, so they prescribe the drug despite its relatively high cost.

It is impossible to unpack all of the reasons for these prescriptions, but some industry critics say one reason could be the money doctors make from Forest. Psychiatrists make more money from drug makers than any other medical specialty, according to analyses of payment data. And Forest gives more money and food to doctors than many of its far larger rivals. Vermont officials found that Forest’s payments to doctors in 2008 were surpassed only by those of Eli Lilly, Pfizer, Novartis and Merck — companies with annual sales that are five to 10 times larger than Forest’s.

Forest’s 2004 plan for marketing Lexapro offers detailed information about how the company planned to direct this money to doctors.

Under “Rep Promotional Programs,” the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers over the course of one year.

“These meetings may be large-scale dinner programs with a slide presentation, small roundtable discussions or one-on-one advocate lunches,” the document states.

Under “Lunch and Learns,” the company intended to spend $36 million providing lunch to doctors in their offices. “Providing lunch for a physician creates an extended amount of selling time for representatives,” the document states.

An entire section of the marketing plan, titled “Continuing Medical Education,” outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks.

“At our recent hearing we asked the question, ‘Is the line between medical education and marketing blurred?’ ” said Senator Herb Kohl, a Democrat from Wisconsin who is chairman of the committee on aging. His panel was given the Lexapro document by the Senate Finance Committee, which has long been investigating drug maker marketing efforts. “These documents show that for these companies, there is no line,” Mr. Kohl said.


Backdoor congressional ethics bill?