President Donald Trump’s pick for the Department of Health and Human Services (HHS) secretary, Alex Azar, was a top executive at pharmaceutical company Eli Lilly when it decided to test an erectile dysfunction drug on children — a strategy meant to extend the drug’s expiring patent. The move extended Eli Lilly’s patent over Cialis, the lucrative drug that acquires over $2 billion a year, for six months.
According to a Politico report, Azar’s company successfully gamed the patent system.
Azar maintains that his top priority at HHS — should he be confirmed — is to bring down drug prices. As a pharmaceutical executive for 10 years, he has largely benefited from keeping drug prices high, and Monday’s report is another example of how far he is willing to go to do just that.
When drugs are granted patent and market-exclusivity, the idea is that manufacturers are reimbursed for the development of the drug and turn a profit. During this time, many companies take advantage of the patent system and raise prices.
“Lilly regularly raised the wholesale price of the drug multiple times a year, usually by 9 percent or 10 percent, far outpacing inflation,” according to Politico.
To retain its lucrative patent, Eli Lilly turned to the 1997 Pediatric Exclusivity Provision. This provision to the Food and Drug Administration Modernization Act intended to improve inadequate data for drugs in children by encouraging pharmaceutical companies to conduct more pediatric testing.
According to a Tulane University analysis of 200 drug trials, pediatric studies are influenced more by sales than pediatric prevalence. “The results suggest that pediatric studies are skewed toward drugs having large sales markets,” the authors said of the study. “We find no evidence of a link between the supply of pediatric studies and the social value of those studies, as reflected by pediatric demand for the drug.”
Eli Lilly tested its erectile dysfunction drug to see how it helps a severe type of muscular dystrophy, which typically affects boys. As Politico reported: the drug didn’t work. The trial was likely more for financial gain, not medical success.
As Politico’s Sarah Karlin-Smith notes, it’s not just Eli Lilly.
its not just $LLY — why some people think we may need to rethink our incentives for pediatric research to get the science we most need…. https://t.co/FiO1QAWqXB
— Sarah Karlin-Smith (@SarahKarlin) January 8, 2018
Pfizer conducted its own pediatric study on the erectile dysfunction drug Viagra. The drug maker believed it could help children with a rare and sometimes fatal lung condition. Two clinical trials studied 234 children between 2003 and 2011. The drug didn’t work, and researchers found it more harmful in some children who took higher doses of Viagra.
Azar told Senate members in November that he wants to fight patent gaming. “We have to fight gaming in the system by patents and exclusivity agreements,” he said. He took a strong position against high drug prices more broadly after facing mounting questions during the Senate health hearing about his pharmaceutical ties. The questions then largely centered around the tripled price of insulin while he was at Eli Lilly. He’ll likely face tough questioning again at Tuesday’s Senate Finance Committee hearing, the panel that is responsible for sending the nomination to the full Senate for a vote.