A news investigation has found that growth of a blockbuster asthma drug linked to serious risks came after doctors who received money from the manufacturer issued new treatment recommendations.
GlaxoSmithKline’s Advair has been prescribed for millions of asthma patients — including children — despite medical records and independent doctors indicating it isn’t the correct treatment. The drug “has been massively overused and often inappropriately prescribed,” according to the Milwaukee, Wisconsin, Journal-Sentinel. The newspaper partnered with MedPage Today to study the use of Advair.
Advair is Proven Treatment for Severe Asthma
Advair was the first asthma drug to contain a long-acting beta-agonist to treat airway constriction and a corticosteroid to relieve inflammation. This combination has been proven effective for the treatment of severe asthma, but experts say the long-acting beta-agonist is not needed in less serious cases.
However, a 2010 study by Medco Health Solutions found that almost two-thirds of mild asthma patients were taking Advair and putting themselves at risk, the newspaper reported. One FDA researcher found that drugs containing long-acting beta-agonists contributed to 14,000 deaths from 1994 through 2007. It is believed that the ingredient may help in the short-term while masking the overall worsening condition of an asthma patient, setting him or her up for a fatal attack later.
“We have no way of identifying who’s going to have that miraculous response to Advair, just as we have no way or predicting who’s going to end up in the cemetery because of Advair,” U.S. Food and Drug Administration physician David Graham said at an agency panel discussion.
Glaxo Settles with Justice Department
Yet GlaxoSmithKline executives pushed their sales representatives to sell Advair as the treatment of choice for all types of asthma patients, the U.S. Department of Justice charged. Advair was not approved for first-line therapy for mild asthma patients. In addition, the government alleges the drug maker tried to influence prescribing decisions by paying kickbacks to doctors in the form of gifts, travel and entertainment costs, speaking fees and continuing education.
The company agreed in July to pay $3 billion to settle criminal and civil charges over the illegal marketing of Advair and its antidepressants Paxil and Wellbutrin. The fraud settlement was the largest payment from a pharmaceutical company in United States history.
Another factor that seems to have influenced GlaxoSmithKline’s $4 billion-per-year Advair sales is the placement of doctors who have financial ties to the company on a panel that wrote the guidelines for asthma treatment. The Journal-Sentinel reports that 15 of the 18 participants on the National Heart, Lung and Blood Institute panel were paid by GlaxoSmithKline or other companies that market beta-agonists. This group of doctors concluded that long-acting beta-agonists combined with steroids were the preferred treatment in adults and children 12 and older, which certainly benefited GlaxoSmithKline.