Researchers who study the effectiveness and safety of asthma drugs are questioning the results of a new study, Reuters reported Aug. 19. The new study examines the safety of a class of inhaled asthma drugs called long-acting beta agonists, which include Serevent (salmeterol) and Foradil (formoterol); and, in combination with inhaled corticosteroids, Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide). The study was conducted by researchers including Dr. David Lang of the Cleveland Clinic Foundation — but it was funded with an unrestricted grant from GlaxoSmithKline, the maker of Serevent and Advair. As a result, say independent researchers, the study’s conclusion — that these drugs don’t increase asthma-related illnesses — is not reliable.
For several years, scientists have suspected that long-acting beta agonists actually increase the chances of serious complications from asthma. In fact, one 2003 study showed that the chance of death was actually higher for asthma patients using the drug than it was for those taking only a placebo. Another study found that the risk is even greater for African-Americans, although it was not clear why that might be. The FDA updated the drugs’ warning labels to reflect that risk three times, in 2003, 2005 and 2006, and recommended in 2008 that long-acting beta agonists be banned as asthma medication.
The study by Lang and his colleagues examined that risk. They examined hospitalizations for asthma in Philadelphia between 1995 and 1999, then checked them against prescription rates for both short-acting and long-acting beta agonists. According to the findings, hospitalizations rose with short-acting beta agonist prescriptions, but fell with more prescriptions for the long-acting drugs. The researchers concluded that the study showed no evidence that long-acting beta agonists increase asthma-related illnesses.
Asthma drug researcher Dr. Christopher Cates of the University of London disagreed. He said the study design was unreliable, at least in part because researchers didn’t determine whether the drugs were prescribed for asthma. (As a dangerous drug attorney, I can add that correlation between two events does not necessarily mean that one caused the other, although dishonest people may try to imply otherwise.) Another independent scientist, Dr. Shelly Salpeter of Stanford University, said the association between long-acting beta agonists and asthma complications is clear from multiple studies. In fact, both doctors said, the medical community has moved on to examining whether these drugs are safe in combination with corticosteroids; recent evidence suggests that they are not.
As a pharmaceutical injury lawyer, I am not surprised that a study funded entirely by GlaxoSmithKline would draw conclusions favorable to GlaxoSmithKline’s drugs. There are 300 million people around the world who suffer from asthma, and Advair alone has $3.8 billion in annual sales. All of those profits and more would be lost to the drug maker if it is forced to remove Advair and Serevent from the market because of safety concerns. Nonetheless, evidence is growing that these drugs may actually raise the risk of a serious asthma-related illness, up to and including fatal illnesses. Under those circumstances, it is, at the least, highly irresponsible to sponsor studies that deceptively claim otherwise. If even a fraction of those 300 million people fall seriously ill because they were misled into believing long-acting beta agonists were safe, the drug maker could be responsible for thousands of deaths and catastrophic illnesses.


Carey, Danis & Lowe represents patients and families that suffered serious injuries because they took an unsafe medication. That includes drugs that were defectively designed and manufactured as oversized, undersized or tainted, as well as drugs whose makers failed to warn patients about life-threatening side effects. These problems can lead to catastrophic injuries to patients who thought they were doing something good for their health, including wrongful deaths, permanent disabilities and tens of thousands in otherwise unnecessary medical costs. Our prescription drug injury lawyers help patients recover that money from negligent manufacturers and hold these drug makers legally responsible for the injuries they cause. Based in St. Louis and southern Illinois, we represent people from across the United States in both individual and class actions.
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