Terri Voepel-Lewis, an associate professor of nursing at University of Michigan in Ann Arbor on the committee admitted that prescribing rates may go down as "codeine prescribing rates" appropriately went down after strong FDA warnings.
But others on the FDA committee disagreed. Jim Tracy, an allergist and associate professor at the University of Nebraska said black boxes would create "obstacles to care" and that patients could "all of a sudden get terrified. And they, without supervision, they just stop their drug."
Committee member James McGough, a child psychiatrist at UCLA, concurred, recalling the FDA's 2004 addition of boxed warnings for child and adolescent suicide on SSRIs and which, in his opinion, backfired. "There's a clear association between declining antidepressant use and increased suicide among youth," he said.
It is noteworthy that while Pharma fought and continues to fight SSRI boxed warnings, both their use and the suicide rate have never been higher. U.S. suicide is 33 percent higher than it was two decades ago and one in eight Americans is on antidepressants. Declining prescriptions of antidepressants clearly aren't causal.
Questions About the Safety of Other Asthma Drugs
Sadly, when warnings could affect drug sales, there is often a battle. When the huge Salmeterol Multi-center Asthma Research Trial, or SMART trial was terminated in 2003 after 16 deaths, 44 intubations and 369 hospitalizations, mostly in African-Americans, boxed warnings were added to Advair and Serevent which contain salmeterol and to Symbicort, Dulera and Foradil which contain the similar, formoterol fumarate. The drugs are known as long acting beta agonists or LABAs.
Pharma assailed the warnings as it did SSRI boxed warnings, citing the National Asthma Education and Prevention Program Expert Panel Report 3 as proof of LABA safety though it was written almost exclusively by industry-funded physicians. For example, William W. Busse, MD who chaired the expert panel listed 21 relationships, many financial, with drug makers in his disclosures.
Bu there were other safety signals, especially concerning Glaxo's Advair. When the SMART trial was terminated, Glaxo sought to tweak the disturbing results causing the FDA to calling the initial analysis "artificial" and ask Glaxo to resubmit data. Additionally, reported Propublica, Glaxo has faced "scores of lawsuits and claims from people whose relatives have died while taking Advair." In 2011, the Justice Department said that Glaxo had exposed patients to "significant safety risks" through its reckless Advair promotion.
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