Since 2001 when the makers of the asthma drug Advair, promised investors that they would make “ungodly amounts of money” they were not lying.
The drug has been a blockbuster drug ever since, raking in more than $4 billion dollars every year since 2007.
Millions of people have used the breakthrough medication, as it combined the GlaxoSmithKline beta-agonist, Serevent, with an inhaled steroid.
And although the sales are through the roof, studies have proven that the drug can be dangerous, especially to children.
According to The Journal Sentinel, Advair and other drugs that contain long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011, according to an estimate by AdverseEvents Inc., a private firm that analyzes incidents reported to the U.S. Food and Drug Administration. The incident reporting system is voluntary, so the estimate likely is low.
In a different analysis in 2008, an FDA researcher estimated the drugs contributed to 14,000 asthma deaths from 1994 through 2007.
Yet despite the deaths related to this drug, medical studies, independent doctors and court records that indicate the drug can be dangerous, why is it that it has been massively overused and often inappropriately prescribed?
In a cooperating investigation by Journal Sentinel and MedPage Today, the investigation found the growth in Advair sales followed new asthma treatment recommendations that were written largely by doctors who received money from GlaxoSmithKline and other companies that market the drugs.
And the FDA sidestepped the concerns of some of its own doctors, who warned of the drugs’ risks, especially among children and African-Americans, the investigation found. Those FDA doctors had urged that Advair and similar products not be prescribed to children and that other long-acting beta-agonists be taken off the market.
The picture of how a potentially dangerous drug became commonly prescribed comes from a Journal Sentinel/MedPage Today review of transcripts of FDA hearings, financial disclosures, medical journal articles and a U.S. Department of Justice complaint against GlaxoSmithKline.
Advair and similar drugs are considered appropriate treatment for more severe cases of asthma where the condition can’t be controlled with just a steroid. But a 2010 study by Medco Health Solutions found that nearly two-thirds of mild asthma patients were taking the combination drug – often without trying a steroid first.
One theory from researchers for why Advair and similar drugs bring increased risk of deadly attacks is that the long-acting beta-agonists can mask worsening inflammation in the lungs. Patients feel better in the short-term, but it may set them up for a catastrophic asthma attack down the road.
At a 2008 FDA advisory panel meeting reviewing the use of the drugs, agency physician David Graham questioned whether it was worth putting an entire population on the drugs just to find that occasional patient who gets better control of his or her asthma, according to a transcript of the meeting.
“We have no way of identifying who’s going to have that miraculous response to Advair,” he said, “just as we have no way or predicting who’s going to end up in the cemetery because of Advair.”
FDA spokeswoman Morgan Liscinsky noted in an emailed statement that in 2010, the agency instituted new safety requirements for the drugs, including that they should be used for only the shortest duration necessary to achieve control of symptoms and then discontinued if possible.
In addition, the agency has said long-acting beta-agonists should only be used with a steroid. The agency also issued warnings in 2006 about the increased risk of deadly attacks.
Liscinsky said the FDA believes the benefits of the drugs outweigh the risks when they are used properly.
This story was reported as a joint project of the Journal Sentinel and MedPage Today. To continue reading the Journal Sentinel’s prospective visit Advair boomed amid health risks. MedPage Today provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.