Big Pharma has been accused of selling drugs that are so dangerous they cause death and drugs that cause the exact conditions they're supposed to treat. The popular asthma drugs Symbicort, Advair Diskus, Serevent Diskus, Dulera and Foradil do both and actually warn on their labels that they cause an increased "risk of death from asthma problems."
Big Pharma and the FDA have known for years that formoterol fumarate, found in Symbicort, Dulera and Foradil, and salmeterol, found in Advair Diskus and Serevent Diskus, can paradoxically cause asthma deaths, especially in children and African-Americans. In fact the FDA has heightened the warnings on the labels several times and convened several hearings about the drugs' safety and some doctors have called for their complete ban.
But the drugs, called long acting beta agonists, or LABAs, are so lucrative--Advair was the fourth best selling drug in the US last year, making almost $5 billion--they are marketed despite their estimated US death toll of 4,000 a year. That's equal to or even more than the number who die from asthma itself!
LABAs, whose aggressive marketing coincided with direct-to-consumer drug advertising, are billed as add-on drugs that treat asthma in a different way than traditional steroid asthma drugs. Traditional, inhaled corticosteriods like Flovent, Pulmicort, Asmanex and Qvar treat asthma's inflammation, while LABAs, prescribed as maintenance or "control" drugs, expand constricted airways and protect against bronchospasm.
But study after study show the "bronchoprotective" effects have a downside. They can "mask" asthma that is actually getting worse though people feel fine, and they can produce "desensitization" or "down regulation" also known as tolerance, in which the more you use them the less they work.
In fact, salmeterol, the drug in Advair and Serevent, is considered so unsafe, a huge trial called the Salmeterol Multi-center Asthma Research Trial, or SMART was terminated in 2003 after there were 16 deaths, 44 intubations and 369 hospitalizations on LABAs, mostly in African-Americans.
At FDA hearings after SMART, Pharma doctors tried to spin the results by saying the patients had been sicker to begin with, that they were too slow to seek medical care and that their self-reports of LABA use couldn't be trusted because patients lie. They also said (somewhat contradictorily) that LABAs don't mask worsening asthma because patients know if they are getting worse (not that they get worse!)--and the deaths can be explained by patients' DNA types. Whew.
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