“The drugmakers have an irreducible conflict of interest when it comes to presenting the data from their studies,” said Dr. Fiona Godlee, BMJ editor-in-chief, during a news conference. “They are not incentivized to create a clear picture of the effectiveness and safety of their drugs at the moment.” The vast majority of trials are funded or conducted by industry or industry-paid experts, she said, and that leads to an overly optimistic view of the medications' benefits.
Others noted during the news conference that it is still routine—and entirely legal—for researchers to withhold the results of clinical trials, and that it's not uncommon to find methodological shortcomings in the design of the studies upon review. Gaining access to clinical trial data has historically been a complicated issue. Drug manufacturers have regarded the information as proprietary, making it challenging for outside groups to replicate the findings.
The push for transparency has been gaining traction, though, including several collaborative efforts in the past year. Relenza manufacturer GlaxoSmithKline started clinicalstudydatarequest.com in 2013, and according to the company's website, Boehringer Ingelheim, Roche, Sanofi and ViiV Healthcare have committed to the data-sharing effort. The website alltrials.net—launched last year in Europe by a group including BMJ, Cochrane the Dartmouth Institute for Health Policy & Clinical Practice—has requested that all past and present trials be registered and their results be reported. In January, Johnson & Johnson entered an agreement to share clinical trial data through the Yale School of Medicine's Open Data Access Project, which will serve as an independent body to review requests from investigators and physicians seeking access.
Still, there is a long way to go, not only in gaining access to data on newer trials being conducted, but also on those from decades ago for drugs currently in use. Tamiflu came to market in 1999.
“This is a multisystem failure,” said Dr. Peter Doshi, assistant professor of pharmaceutical health services research at the University of Maryland and a part of the team reviewing the Cochrane research for publication in BMJ. It is assumed that both the CDC and FDA had access to the same 150,000-plus pages of data on Tamiflu and Relenza, he said during the news conference, but the federal agencies did not agree on the evidence supporting basic claims nor the potential risks of the drugs.
“When they are fundamentally at odds about the basic assumptions that have gone into billion-dollar stockpiling decisions, they need to reconcile those differences. That is completely unacceptable.”
Follow Sabriya Rice on Twitter: @MHSRice