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 guidelines were issued by the National Heart, Lung and Blood Institute for treating asthma that included a recommendation that long-acting beta-agonists should be the preferred add-on treatment in combination with inhaled steroids, both in adults and children aged 12 years and older (read here).
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."
Meanwhile, Advair and other long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011, according to an estimate by AdverseEvents. In another analysis presented at an FDA advisory panel held in 2008 to review the drugs, FDA researcher David Graham estimated that long-acting beta agonists contributed to an estimated 14,000 asthma deaths from 1994 through 2007. Advair is the biggest seller, the media outlets note.
The estimate was disputed by a Glaxo spokeswoman, who maintained there were no such deaths in other research involving 18,000 Advair patients. She was referring to 86 separate clinical trials sponsored by the drugmaker. But Sanjay Kaul, a physician who has served on FDA advisory panels and is an expert on drug safety data and clinical trial design, says this is not comforting.
In large clinical trials, the web sites write, patients are typically divided into groups with similar risk factors such as age, severity of disease and other drugs they are taking - all of which can affect mortality. That can vary significantly across many trials. "Zero deaths reported from 18,000 patients in 86 different trials doesn't supply any evidence of reassurance," he says.
"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."