It has been a rough month for Big Pharma. Johnson & Johnson settled several Federal cases concerning Risperdal for a whopping $2.2B after the giant unethically and illegally promoted off-label uses for its anti-psychotic drug a decade ago. Among the findings was the news that J&J may have withheld some trial data, which prosecutors tackled in part by requiring the company to sign onto certain compliance programs and trial transparency measures. Meanwhile, Astrazeneca is facing its own trial misconduct issues as the DOJ is now investigating potential data suppression or masking in the major PLATO trial for antiplatelet drug Brilinta (Ticagrelor).
Both ongoing stories come as there is a growing push for transparency in clinical trials led by groups like AllTrials and to an extent even the government through ClinicalTrials.gov and the Affordable Care Act. While the trial transparency movement seems to be growing and negative pharma publicity only potentiates that push, there are still some additional possibilities that can further the cause.
Now this is purely speculative and there may be a good reason why it has not happened (please share if you have some insight), but payers may just be the key to the lock of getting greater clinical trial transparency. They naturally have an incentive against paying for expensive brand name drugs, especially when there are viable generic alternatives on the market or if the efficacy is not really proven. Withheld data or misleading trial conclusions actually hurt payers’ bottom lines via higher cost, lower return medications. Given the current cost-cutting climate, a change forcing manufacturers to release trial information could improve outcomes while cutting costs in both the short and long terms. Given Express Scripts’ 2014 formulary exclusion of Advair in preference of cheaper, but effective alternatives, a move making more brand name coverage (or preferred tiering) contingent on greater transparency hardly seems like a bad idea.