U.S. regulators gave GlaxoSmithKline's ($GSK) Advair the green light a decade and a half ago, paving the way for a long reign that saw the med grow to more than $8 billion in annual sales. But even after all these years, whether Advair poses a higher risk of asthma-related death remains unclear, ProPublica says.
Recent research suggests that a significant percentage of asthma patients begin using Advair inappropriately, the watchdog says, and that can trigger the "risk of asthma-related death" described on the med's label. And while the FDA in 2010 required Glaxo and other drugmakers to launch large studies to assess the risks, results for those aren't due until 2017.
Concerns first arose in 1993, with more worrisome results arriving in 2003. Through it all, ProPublica notes, the British pharma giant has settled lawsuits brought by family members of patients who died while taking Advair--all the while keeping its marketing going full-steam. GSK also paid $700 million in 2012 to settle federal allegations that illegal Advair promotion contributed to extensive misuse, ProPublica points out.
GSK, for its part, insists Advair is safe when used properly, and it told ProPublica in a statement that dozens of studies have displayed its "positive safety profile" and superiority to other asthma therapies. In more than 15 years of Advair trials--involving 30,000 patients--the company has recorded no asthma-related deaths.
"We are proud to be in the forefront of research and development in the respiratory field and to have helped millions of patients with asthma," the drugmaker said, adding that patients could suffer if too much emphasis on risk convinced them to stop taking Advair.
Whether Glaxo likes it or not, though, Advair use is on the downswing, with formulary positioning and competition taking their toll in the U.S. In Q1 of this year, stateside Advair sales plummeted 22%, and the company acknowledged that those numbers could go from bad to worse once generics hit--conceivably in the not-too-distant future.
- read the ProPublica story
Special Reports: The top 15 companies by 2014 revenue - GlaxoSmithKline | Pharma's top 10 M&A deals of 2014 - GlaxoSmithKline Oncology/Novartis Vaccines (excluding flu) | The 10 best-selling drugs of 2013 - Advair/Seretide