Glaxo defends Avandia with full-page newspaper ads

By Bill Berkrot

NEW YORK (Reuters) - GlaxoSmithKline Plc fired another salvo in defense of diabetes treatment Avandia on Tuesday by taking out full-page advertisements in at least a dozen major U.S. newspapers in an attempt to reassure patients of the safety of the widely used medicine.

The ads, which appeared in newspapers such as The New York Times, The Washington Post, USA Today and The Wall Street Journal, take the form of a letter to Avandia patients signed by Ronald Krall, chief medical officer of the world's second- largest drugmaker.

The unusual step comes a day before a scheduled U.S. congressional hearing on the Food and Drug Administration's role in evaluating the safety of Avandia, and a day after the first solid data became available on the medicine's eroding prescription numbers.

Avandia, known chemically as rosiglitazone, came under fire last month after an analysis in the New England Journal of Medicine suggested the type 2 diabetes treatment might raise the risk of heart attack by 43 percent and of cardiac-related death by 64 percent.

The analysis by a top U.S. cardiologist, Steven Nissen, drew on pooled data from 42 trials involving nearly 28,000 patients.

Glaxo has been on the defensive ever since, putting out news releases criticizing the so-called meta-analysis and methods used in reaching its conclusions, and defending the safety of the $3.2 billion a year product.

The damage control efforts also included trotting out executives to discuss Avandia safety with the media and publishing a letter in the Lancet medical journal saying large studies showed Avandia's cardiovascular safety to be comparable to other widely used diabetes treatments.

While the newspapers would not discuss specifically what Glaxo paid for its eye-catching Avandia letter, a New York Times spokeswoman said a full-page ad with color in the A-section of the paper typically costs about $110,000.

USA Today said a full-page ad with color goes for $168,600 and the additional black and white half page with required label insert information on the medicine cost another $72,140.

Glaxo declined to reveal the cost of the media blitz. Such direct to consumer advertising is illegal in Europe.

"These advertisements reflect GSK's commitment to stand firmly behind Avandia when used appropriately and aim to reassure patients and physicians," a Glaxo spokesman in London said. "Avandia is an effective medicine that is an important treatment for millions of patients with diabetes, a disease with devastating consequences if left unmanaged."

Type 2 diabetes, which is growing at alarming rates, is the most common form of the disease in which the body does not produce enough insulin to control blood sugar levels and can lead to a wide variety serious health complications.

The Dear Avandia patients letter begins, "We at GlaxoSmithKline are proud to be the maker of Avandia ... We also understand the confusion and concern you may have experienced following recent press coverage about the safety of Avandia."

It goes on to say, "GlaxoSmithKline has conducted an unprecedented number of clinical trials in order to continuously evaluate the safety of Avandia, including its impact on the cardiovascular system."

The four paragraph letter concludes, "Be assured, GSK gives you our full commitment to providing you and your doctor with the facts about the safety of Avandia."