Still, unlike drugs that look safe in trials and develop safety signals postmarketing, the long-acting beta agonists (LABA), salmeterol and formoterol, found in many asthma products, never looked safe. In fact it was their links to deaths and adverse events that led to studies in the 1990s and 2000s which showed more deaths and adverse events: LABAS increase death in users, say the studies, especially African-Americans and children.
Original safety trials were also marred with major fraud click here
Pharma doctors, when reviewing the study results at FDA hearings in 2005 and 2008, blamed LABA deaths on patients' underlying disease and non-compliance and dismissed hospitalization as a side effect less serious than death. They danced around FDA testimony, including from Dr David Graham of Vioxx fame, that there is no scientific evidence that the inhaled corticosteriods found in Advair and Symbicort make the products safer and that LABA's modest clinical benefit does not justify their 28-fold increase in mortality risks. (5,000 deaths in ten years estimated Graham.)
While many regard LABAs as a medical mishap, marketing for "step up" asthma treatment is no mistake. Though inhaled corticosteriods are still considered the best asthma treatment, millions have been convinced they need two drugs to control their asthma and that the combination is keeping them out of hospitals. Except when it isn't.
Singulair and Accolate, leukotriene receptor antagonists
How did Merck convince Americans to use an allergy drug that works no better than over-the-counter antihistamines but costs eight times as much?
A drug in which "asthma control deteriorates when switched from low dose inhaled corticosteriods" according to original FDA reviewers in 1998 -- but was approved anyway?
How did Merck convince pediatricians and mothers to give kids such a drug on a daily basis for seasonal allergies, runny noses and minor wheezing? Even though FDA reviewers cautioned that adult trials "may not be predictive of the response" in children in the New England Journal of Medicine? And infant monkeys given Singulair had to be euthanized because "infants may be more sensitive" FDA reviewers wrote?
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