GSK And The Advair Controversy

From Pharmalot: 

Full Story –

“It is very hard for many of us,” David Schoenfeld, a Harvard University medical professor who served on the FDA 2008 advisory panel and has been a drug company consultant, “to make decisions that are against the American pharmaceutical industry.”

When GlaxoSmithKline reached its infamous $3 billion settlement with the US Department of Justice last summer, much of the attention was focused on the guilty pleas for misbranding the Paxil and Wellbutrin antidepressants and for failing to report safety data about the Avandia diabetes pill to the FDA (back story).

In fact, however, there were several transgressions, such as reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program and off-label promotion of several medications. One of these was the Advair asthma treatment and, as it turns out, the drug got an extra push from yet another dicey, behind-the-scenes scheme.

And that was? The growth in Advair sales – revenue has topped $4 billion annually for several years – followed new asthma treatment recommendations that were written in 2007 largely by doctors who received money from Glaxo and other drugmakers that market similar medications, according to The Milwaukee Journal-Sentinel and MedPage Today (read here).

Of the 18 members of the panel that wrote the guidelines, 15 had financial ties at the time to Glaxo (GSK) or other drugmakers that market long-acting beta-agonists. And from 2009 through 2011, drugmakers that made long-acting beta-agonists paid more than $400,000 to nine doctors on the panel, according to ProPublica data cited by the news outlets.

The government, however, alleged that Glaxo fraudulently promoted Advair as a first-line therapy for mild asthma patients, although the medication was not approved or medically appropriate for such cases. A Glaxo spokeswoman told the web sites that “it is absolutely against GSK’s policies and practices to inappropriately influence prescribing decisions,” and adding that such practices do not reflect “the company we are today.”

Comment :

It is likely the case that each of GSK’s “blockbuster” drugs acquired that status through various forms of fraud. Advair’s rise to pre-eminence was based largely on the SMART study, which internal documents called a failed study. That didn’t stop GSK from applying its vast array of Junk Science and Junk Statistics techniques to promote that study as vindication of Advair’s safety and efficacy.

GSK could have been criminally prosecuted based on that one study alone, and even widespread adverse publicity, such as was not enough to overcome its well-practiced doctor bribery and intimidation program.

Does this company make ANY product that is not harmful to humans? Not so’s you can tell…