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.
LABA defenders even said the SMART results couldn't be trusted because the trial was stopped early.
Usually, the justification for unsafe drugs like LABAs is that their benefits outweigh their risk. But at FDA hearings three years later, David Graham, MD, an FDA official, said LABA "benefits, if any, seemed to be small compared to placebo." He also blew the whistle on the widespread Pharma myth that a decline in US asthma deaths over the last decade is due to LABAs.
"It is true that trend for reported asthma deaths has declined over time, " he said in the hearings. "But nobody has shown that the decline has anything to do with LABA use." Fifty percent of the decline "is due to the change in classification coding from IC-9 to ICD-10," said Graham, known for testifying before Congress about Vioxx dangers.
While the number of asthma deaths is down, the number of asthma sufferers is growing--and no one really knows why. Some cite more pollens in the air from global warming and the "hygiene theory" that we have created such a germ and dirt free environment, our immune systems can't differentiate real threats from harmless pollens or dust.
Others cite burgeoning prescription drug use. Researchers at Henry Ford Hospital found children given antibiotics within their first six months of life were more likely to develop allergies. Data presented at the American Academy of Allergy, Asthma & Immunology suggest children whose mothers took prescription acid-blocking drugs like Nexium during pregnancy are more likely to suffer symptoms of asthma. And research in the American Journal of Respiratory and Critical Care Medicine found that Tylenol may be, "an important risk factor for the development and/or maintenance of asthma, rhinoconjunctivitis and eczema in adolescent children." Meanwhile, a 1999 European Union report speculates about the role of sex hormones and meat additives in asthma.
A Volume Business by Martha Rosenberg
To prove that LABAs are safe and effective, Pharma not only points to falling US asthma deaths rates, it points to LABAs' inclusion in government asthma guidelines . Even though Pharma doctors wrote the government guidelines!
William W. Busse, MD, from the University of Wisconsin School of Medicine and Public Health, chaired the expert panel which developed the government's 2007 National Asthma Education and Prevention Program Guidelines--even though he is financially linked to GlaxoSmithKline, Merck, Novartis, Pfizer Genentech/Novartis, Schering and five other Pharma companies. According to the guidelines themselves.
No wonder federal guidelines extol the "established beneficial effects of LABA for the great majority of patients who require more therapy than low-dose ICS alone to control asthma," and call LABAs a "preferred option" that "improves lung function, decreases symptoms [and] reduces exacerbations!" Not that we have an opinion.
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