It’s a story, yet again, of a pharmaceutical company developing financial relationships with doctors and medical organizations in order to inappropriately broaden the sales potential of one of its drugs.
The drug in this case is Advair, which is used by millions of people with asthma, a chronic inflammatory disease that causes the airways to become inflamed and constricted, leading to wheezing, coughing and difficulty breathing. Although asthma is usually non-life-threatening, more than 3,000 Americans die from the disease each year, according to the Centers for Disease Control and Prevention.
Advair combines a long-acting beta-agonist, which helps the muscles of the airways relax and become less constricted, with an inhaled steroid, which treats inflammation. It’s supposed to be prescribed only to patients with severe symptoms that can’t be controlled by an inhaled steroid alone. There’s a good reason for this caution: Advair and similar combination asthma drugs can be dangerous, particularly for children.
But, as Journal-Sentinel reporter John Fauber notes, a 2010 study found that two-thirds of asthma patients with mild symptoms were taking Advair without trying a steroid first.
Fauber also reports that Advair and other asthma drugs that contain long-acting beta-agonists have been linked to 1,900 deaths in the years 2004 through 2011, a number that is probably low, he adds, because the reporting system is voluntary. Another analysis completed in 2008 estimated that Advair and similar drugs contributed to 14,000 asthma deaths between 1994 and 2007.
How did a drug meant for only the severest cases of asthma come to be commonly prescribed? To answer that question, Fauber reviewed transcripts of Food and Drug Administration (FDA) hearings, financial disclosures by physicians and medical organizations, medical journal articles and a U.S. Department of Justice complaint against GlaxoSmithKline.
Here, in part, is what he found:
In July, GlaxoSmithKline agreed to pay a record $3 billion to settle criminal and civil allegations filed by the U.S. Department of Justice that it unlawfully promoted several drugs, including Advair.
The government alleged that the company fraudulently pushed Advair as a first-line therapy for mild asthma patients, though it was not approved or medically appropriate for such cases.
In addition, the company paid kickbacks to doctors to induce them to prescribe and recommend Advair and other drugs, according to the complaint. The payments included speaking and consulting fees; gifts, travel and entertainment costs; payments for serving on “sham advisory boards;” and continuing medical education programs.
[Spokesperson Karen] Collins, of GlaxoSmithKline, said the company disputes the government’s allegations and said there was not a corporate strategy to promote Advair for inappropriate patients.
“The company reached this settlement with the government to avoid the delay, expense, inconvenience and uncertainty of protracted litigation of the government’s claims and to put behind us these long-standing investigations of what was, for the most part, very old conduct,” she said.
The financial links between the asthma drug companies, the medical associations that promoted the drugs and the doctors who wrote treatment guidelines that recommended the drugs followed a pattern identified with other drugs in earlier investigations by the Journal Sentinel/MedPage Today.
In 2007, the National Heart, Lung and Blood Institute issued new guidelines for treating asthma that included this recommendation: Long-acting beta-agonists should be the preferred add-on treatment to combine with inhaled steroids, both in adults and children aged 12 and older.
Of the 18 members of the panel that wrote the guidelines, 15 had financial ties at the time to GlaxoSmithKline or other companies that market beta-agonists, according to research by the Journal Sentinel/MedPage Today.
Fauber describes many more troubling details about the over-selling of Advair. You’ll find his article on the Journal Sentinal’s website.