A study posted on the JAMA Internal Medicine website shows a decade-old environmental regulation didn't stop asthma patients from using inhalers as some had feared. But one doctor argues that it also probably did little to improve the environment but made lots of money for drug companies that lobbied for the rule.
The Food and Drug Administration issued a ruling in 2005 stating that in order to be compliant with the U.S. Clean Air Act, generically available albuterol inhalers using chlorofluorocarbons would be banned. The propellant CFC was found to harm the Earth's ozone layer by releasing chlorine gas into the atmosphere.
Conducted by researchers at the Harvard Medical School and other institutions, the study used insurance company records from between 2004 and 2010 to determine the impact of the FDA decision. They found that the per-prescription costs for insured patients originally increased from $13.60 in 2004 to $25 in 2008 after the ban went into effect. The cost eventually decreased to $21 by the end of 2010.
It was estimated that the cost increase temporarily lowered inhaler utilization by about 5%. The authors speculated that patients “may be reluctant to reduce use of medications that quickly relieve symptoms.” They added that the cost increase did not lead to an increase in asthma-related hospitalizations, emergency-department visits or outpatient visits for the insured patients studied. They acknowledged that they could not say whether the same was true for patients without insurance.
Dr. Rita Redberg of the University of California San Francisco department of medicine wrote an accompanying editorial that noted that “the goal was clean air, not increased pharmaceutical profit.” But, Redberg wrote, patients were forced to pay more for their prescription but received no added benefit for the additional cost. She also argued that the ruling likely had no meaningful impact on the environment either.
“Surely the intent of the FDA in enforcing this clean-air statute was not to enhance the profits of pharmaceutical companies and make yet another drug that has been around for decades less available to many Americans because of its high cost,” Redberg concluded. She added that the FDA ruling was in response to “vigorous lobbying by a pharmaceutical consortium,” and was not the result of groups campaigning to protect the environment.