and lawsuits. Earlier this year, those crunching the 329 data again published a very different story.
Not only was there no benefit compared to placebo, but also, they wrote, “there were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.” (Imipramine is an even older type of antidepressant that was used as a comparator in the trial.)
Miller called the company’s behavior a “cover-up” that increased the risk of suicide in teenagers. GSK has already paid for its sins, including $3 billion in fines in 2012, and is now a vocal proponent of data disclosure.
Might the new scorecard prompt other companies to shed more sunshine on their trial data? Miller hopes so, but she stressed that giving negative ratings “aren’t about shaming bad practices,” said Miller. The scorecard is “about providing opportunities and letting every company understand how they’re performing related to ethical and legal standards.”
She also acknowledged that the 2007 FDAAA rules for disclosure—the legal letter of the law—contain unclear language, which could be contributing to some of the low scoring.
In the end, will commitments to transparency help anything beyond a company’s PR image? If a paroxetine-like situation can be avoided, the answer is clearly yes. And less dramatically, the slow but steady accumulation of information about a drug could lead to new ideas and new uses for it.
When I asked Miller where else transparency has helped, she mentioned restaurant inspection ratings leading to less foodborne illness outbreaks. It’s unclear whether a comprehensive study has been conducted, but there are reports here and there of local successes. An oft-cited 2005 study showed that Los Angeles County, which includes the city of Los Angeles and many other towns, had a decrease of foodborne illness in the first few years after it began its program.
In Toronto, officials credit their city’s inspection system for a 30 percent drop in cases of foodborne illness, according to the Canadian Broadcasting Corp.
Miller’s transparency report is part of a larger effort to hold the drug industry accountable for practices that make it a nearly perennial loser in the court of public opinion.
For the 15 approved drugs studied, there were nearly 100,000 participants involved. Nearly half the drugs had at least one undisclosed Phase 2 or Phase 3 study. In following years, the researchers hope to expand the scorecard beyond the biggest drug companies, a wise move considering drug programs are increasingly targeting smaller groups of patients, often with rare diseases, which could let companies with less financial clout afford to take drugs all the way through to market.
So entrepreneurs, scientists, and investors in the biotech space, take heed. Clinical transparency isn’t just a Big Pharma issue. As the movement gains momentum, there will be fewer excuses to hide behind trade secrets or competitive advantage. The world will want to know your results, and how you achieved them.
