More than a third of clinical trial drug data was not publicly reported according to a paper published last week  in BMJ Open. The study was well covered by the Washington Post, and serves as the basis for the lead author, Dr. Jennifer Miller’s non-profit, Bioethics International which will publicly grade the transparency of drug companies.

Shocking? Not really. Selection bias has long been rampant in pharmaceutical publishing, and among those making drug decisions it is a well-known phenomenon. In the EY Progressions 2014 Payer Survey, 85% of respondents said they were concerned that manufacturer provided data are biased.  So while it certainly is disturbing that despite the industry’s vocal “dedication” to transparency it has still not yet materialized, this study certainly shouldn’t have shocked anyone.

So why should we care about a study that reports on the obvious? I think Dr. Miller said it best, “It’s impossible to have evidence-based medicine without the evidence."

So clearly, the real question we should all be asking is not about the two thirds data that are available but the third hidden-away. What is being excluded from public view? And why? One would assume and hope that the FDA would not approve a drug if the unpublished studies it has access to, were grossly negative, but you have to wonder why a company would choose not to publish data, particularly in a political environment where “transparency” is the word of the day. We are willing to go out on a limb and say that they did not NOT publish superior efficacy and safety results.

As Brian Overstreet, Advera Health’s CEO, stated in the November issue of PharmaVoice, “the health economy will rely on broad datasets to better monitor, control and mitigate patient risks and systems costs.”  So it really is a very simple equation – the more data (evidence) available, the better chance patients will have access to safer and more effective medications, and providers and payers will be able to lower costs. The “missing third” needs to be publicly available, because that data could serve as leading indicators of safety concerns that could help validate post-marketing signals. Ethical concerns aside, it is the law. Isn’t it time someone starts enforcing it?

The BMJ Open paper is just another example of how data is power and that with the current industry dynamics our work at Advera Health is again validated.

It validates the work that we have put in to make real world post marketing side effect data accessible through big data standardization and Freedom of Information Act requests. So that regardless of what data was not revealed before approval, healthcare decision makers can still have a unique view into the true safety profiles of drugs, with or without manufacturers support or data sanitization.

It validates the creation and need for actionable analytics that provide an early warning system to patient harm, prior to FDA action.

It validates that making safer drugs available to prescribers and patients through an optimized formulary not only reduces harm, but has a true economic impact.

So, while we will no doubt continue to see more research that highlights disturbing deficiencies in the drug development and regulatory process, we think it’s more important to do something about it.

Joseph Ross, associate professor of medicine at Yale University School of Medicine and another of the authors of the BMJ paper stated “if you’re selling a product on the U.S. market, the public and the clinical science community has a right to be able to review the results,” we would take it a step farther and say not only do they have a right but an obligation. An obligation to ensure that what is approved and prescribed to the public is vetted on complete, accurate and detailed evidence.

So while we encourage the FDA to improve their own FAERS data processes, we also encourage them to start enforcing the law. 100% transparency on all drug data – it’s the public’s right and the government’s obligation.

To learn more about how Advera Health’s analytics are being used by healthcare decision makers to improve patient outcomes and lower healthcare costs, let us know, we’d be happy to validate Advera Health further…

Topics: FDA

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.