Transparency in the pharmaceutical industry has become a hot topic. Last October, the National Institutes of Health (NIH) launched the Open Payments website to make good on the promise of the Physician Sunshine Payment Act—disclosing all payments to physicians and medical institutions from drug companies.
Then, in late November, NIH proposed forcing pharmaceutical companies to put all clinical trial data—and not just data from successful trials—online, with the exception of phase I and feasibility studies.
The transparency initiative goes beyond the U.S. In the UK, transparency advocates took the data-transparency proposal one step further in September when more than 80,000 individuals and 500 organizations signed the AllTrials petition demanding that drug companies put all clinical trial data, both past and present, online. And in Japan, legislators passed a bill similar to the Sunshine Act in the U.S. requiring that drug makers fully disclose all payments to physicians and hospitals. Reporting started last August.
Technology makes transparency easier
Rapidly developing technology with big-data applications facilitate the ability to collect and organize an almost endless stream of information. Nonetheless, transparency remains a problem, according to a report published by the Cochrane Collaboration in April 2014, highlighting evidence that a significant amount of clinical data goes unpublished.
The upside of transparency is that researchers gain access to hard-won knowledge gleaned from other investigators, while practicing physicians are able to evaluate treatment options and dig deeper into the medical literature to get the answers they need.
As for patients, transparency and access to data make them more empowered. Instead of simply relying on a Google search or consumer health sites, patients who want to learn more about a particular treatment can pull up actual clinical study reports to help them make what may be the most important decision of their lives.
Despite a series of initiatives designed to promote full-out transparency, including a 2007 law in the U.S. that makes failure to register clinical trial results illegal, the goal of full transparency remains elusive.
The Tamiflu conundrum
Tamiflu (oseltamivir), which is manufactured by Roche as a treatment for the influenza virus, was approved by the FDA in 1999 before the 2007 data-transparency law was passed. Since approval, there have been numerous reports and anecdotes detailing Tamiflu-induced psychosis, including some that culminated in suicide. All told, more than 70 people have died after taking Tamiflu, including non-suicide deaths, as well as psychosis-induced suicides, according to an article by Ben Wolford published in Newsweek last November.
When reports about Tamiflu-related adverse events started to leak out, the Cochrane Collaboration decided to initiate an investigation, but had to resort to filing Freedom of Information Act requests to obtain all of the clinical data from studies conducted evaluating Tamiflu. It took five years to obtain the data, which included more than 100,000 pages of unpublished reports—including reports detailing psychiatric adverse events, which had not been made public. Roche has never faced any penalties or censure for failure to disclose this information.
The problem of ‘publication bias’
Given the widespread problem of lack of transparency, Roche is not alone in its “publication bias” in which large amounts of negative data are unpublished and unavailable for review, while data confirming effectiveness and safety are readily available.
The British Medical Journal also investigated the Tamiflu situation and found that Roche was but one company that was not disclosing large amounts of clinical trial data. In one analysis, BMJ found that 32% of industry-funded studies were likely to remain unpublished, compared with 18% of studies not supported by industry.
But pharmaceutical companies face many challenges when designing and conducting clinical trials with the goal of bringing new drugs to market.
Perspective of a clinical investigator
From the perspective of Dr. Richard Wasserman, Clinical Professor of Pediatrics at the University of Texas Southwestern Medical School, who often leads clinical investigations, “Clinical trials are getting harder and harder as the FDA appears to be ever more demanding regarding the detail of data collected and the complexity of data acquisition and entry increases.”
Still, Dr. Wasserman takes pains to contribute to the integrity of clinical trial reporting. He explains, “Sometimes as a study progresses, there may be questions about the validity of the data. I don’t believe that 100% of trial data should be published, but I do believe that almost all of the data generated in trials should be publicly available. Having said that, it would be nice if there were a repository for data that wouldn’t get published in a credible journal.”
Roche as an advocate for clinical trial data transparency
Although the Tamiflu controversy has become an important touchstone in the discussion around transparency in the pharmaceutical industry, Roche has emerged in the last several years as a major advocate of transparency and a leader in promoting shared data.
In June 2013, Roche made public the “Roche Global Policy on Sharing of Clinical Trials Data.” According to a company statement, “Roche believes that data from clinical trials should be made available to both physicians and patients, to help them make the most informed decisions possible when choosing among treatment options. We believe this should apply to clinical studies sponsored by pharmaceutical companies as well as those conducted by academic institutions and governments.”
In Part 2 of our transparency series, BioPharma Dive will speak with a practicing physician about his views on data transparency and how it influences his approach to prescribing.