Not only did Pfizer just settle a case for the largest criminal fine in the history of the United States, but the Senate has obtained a copy of the marketing plan for the antidepressant Lexapro. Just toss it on the pile of evidence of how many drug makers operate.
The Justice Department announced today a $2.3 billion settlement with Pfizer over allegations that Pfizer marketed the anti-inflammatory drug Bextra (and possibly other drugs) for unapproved uses. From the Wall Street Journal:
Pfizer promoted the sale of Bextra for several uses and dosages that the FDA declined to approve for safety concerns, the Justice Department said. The FDA approved Bextra to treat arthritis, rheumatoid arthritis and menstrual pain.
Authorities also said Pfizer sales representatives created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.
Pfizer took Bextra off the shelf in 2005, and as part of the settlement, the company says it has implemented new measures to prevent this kind of thing from happening again.
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.
Drug companies can’t pay doctors directly to prescribe certain medicines. That’s illegal. But you can pay doctors to educate other doctors about a drug.
In the case of Lexapro, it’s basically just a slightly altered version of a drug called Celexa. For years, Forest pushed Lexapro as a superior alternative to Celexa, even though, the FDA did no tests to validate that. The FDA treats the drugs as basically the same:
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.
We’ll see what happens to Lexapro sales now. Here’s the key graph of the Times story:
“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.