Glaxo Courts Doctor Support of Avandia

[JohnMack]

Source: Wall Street Journal

No Plans Currently Set
To Run Consumer Ads
To Defend Drug's Safety
By JEANNE WHALEN and ANNA WILDE MATHEWS

GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety, but isn't currently planning a similar ad campaign for consumers.

In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman.

Monday, the New England Journal of Medicine released an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. Glaxo disagrees with the finding, which it says is contradicted by data the company considers stronger, including ADOPT data.

Congressional investigators are examining the Food and Drug Administration's and the company's handling of the drug. Yesterday, Republican Sen. Charles Grassley of Iowa said that the FDA's division of drug-risk evaluation had recommended a tough "black box" warning about heart-attack risk for the label of Avandia, which hasn't been added. He and Senate Finance Committee Chairman Max Baucus, a Montana Democrat, introduced a bill that would grant researchers access to Medicare data on medical treatments.

The FDA said that it can't discuss continuing regulatory matters. The agency has said it has conflicting data from different sources about the safety of Avandia, slowing a regulatory decision.

[See, however, "FDA Study Said to Show Avandia Risk"]

In a sign of tension between Capitol Hill and the agency, Reps. John Dingell and Bart Stupak, both Michigan Democrats and leaders of the House Energy and Commerce Committee, complained in a letter that responses to their requests for information from the agency on a range of topics have been "unacceptable." The FDA said it "has been as responsive as possible."

Dr. Nissen's analysis led to a sharp drop in Glaxo's stock price, and some analysts have predicted Avandia sales could be cut in half. The Glaxo spokeswoman said the company isn't planning consumer ads defending Avandia, but won't rule them out, either. "At the moment, there is an information vacuum, and GSK may need to step into the void," she said.

The ADOPT trial was published in December 2006 in the New England Journal of Medicine. Patients, treated for about four years, showed positive results for Avandia in treating diabetes. The patients taking Avandia had a higher rate of heart attacks than those on glyburide, though, and very slightly more heart attacks than those taking metformin.

An ad for physicians ran in the Journal of the American Medical Association in November 2006.

Glaxo says this difference didn't achieve statistical significance, which means it could be the result of chance. But Dr. Nissen says the ADOPT result helped fuel his concern about Avandia's potential heart risk.

Glaxo hasn't advertised Avandia on U.S. television in the past year. Recent ads in consumer magazines and medical journals have touted Avandia's effectiveness.

"Every day, I struggle to keep my blood sugar under control. Where can I go from here?" a woman asks in an ad that ran in Better Homes & Gardens last November. Another ad in Woman's Day magazine last October offered patients $30 off on Avandia if they signed up for an Internet-based program that reminds patients to take their medicine and offers healthy-lifestyle advice.

A Glaxo spokeswoman said the company was taking a short break from U.S. Avandia ads when the safety concerns arose, and this break was unrelated to the concerns.

In the past, Glaxo played up signs that its drug could hold cardiovascular benefits. A press release in June 2003, headlined "New Studies Suggest Avandia May Provide Certain Cardiovascular Disease Benefits," boasted of the results of studies, including one that showed Avandia might improve markers tied to cardiovascular problems.

Glaxo later did its own analysis, which it posted on its clinical-trials Web site, with a finding somewhat similar to Dr. Nissen's. Glaxo says stronger evidence favoring Avandia's safety outweighs it.

For a few years, Avandia's label has warned that the drug, like similar treatments, might exacerbate or lead to heart failure, which is different from heart attacks. The warning also noted that when taken with insulin, such drugs may "increase the risk of other cardiovascular adverse events."

Last year, the Avandia label warning got new language saying patients with heart failure who took Avandia had a higher risk of cardiovascular events. The Glaxo analysis showing potential heart-attack risk hasn't been placed in the U.S. label.

Write to Jeanne Whalen at jeanne.whalen@wsj.com and Anna Wilde Mathews at anna.mathews@wsj.com

[Also see "Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did"]