Glaxo to Shift Away from Antidepressant Research CEO admits antidepressant research only based on subjective mood surveys

Wall Street Journal
By Jeanne Whalen
February 5, 2010

GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.

Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.’s Prozac and Pfizer Inc.’s Zoloft, also generated big sales for those companies.

However, low-cost generic copies have eroded demand for name-brand antidepressants, which accounted for just 2.3% of Glaxo’s total sales last year, down from 14% in 2002. Chief Executive Andrew Witty said Thursday that the company thinks further investment in the market wouldn’t be prudent.

Part of the reason is financial risk. Clinical trials of antidepressants are among the “most expensive and highest-risk” of all drug trials, Mr. Witty said, because companies often don’t know until the end of very large studies whether a drug works. It is also hard to prove that a depression drug is working, he said, because patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.

That’s a drawback in an era when insurers and other health-care payers want to see clear value for their money, Mr. Witty said.

Payers “want big benefits to make it worth their while to invest their resources,” he said, adding that Glaxo would scrap research into pain drugs for the same reasons, focusing instead on diseases including Alzheimer’s, Parkinson’s, multiple sclerosis and a clutch of rare diseases.

Glaxo used ghostwriting program to promote Paxil

Associated Press
August 19, 2009

By MATTHEW PERRONE (AP)

WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.

But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.

According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.

"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."

McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.

"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.

Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.

(This version CORRECTS spelling of 'Baum' in graf 4.)

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