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 serves as the basis for the lead author Dr. Jennifer Miller and her 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 manufacturer-provided data are biased. So while it certainly is disturbing that despite the industry's vocal dedication transparency still has not yet materialized, this study certainly shouldn't shock anyone.
Why should we care about a study that reports on the obvious? Dr. Miller said it best: "It's impossible to have evidence-based medicine without the evidence."
Clearly, the real question we should all be asking is not about the two-thirds data that are available but the one-third hidden away. What is being excluded from public view, and why? One would assume and hope the FDA would not approve a drug if the unpublished studies it has access to were grossly negative. But I have to wonder why a company would chose 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, says, 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 with the current industry dynamics there is a need for technology-based systems to make real-world, post marketing side effect data accessible through big data standardization and Freedom of Information Act requests. Regardless of what data was not revealed before approval, healthcare decision makers should still have a unique view into the true safety profiles of drugs, with or without manufacturers' support or data sanitization.
It validates the need for actionable analytics that provide an early warning system to patient harm, prior to FDA action. And, it validates the idea that making safer drugs available to prescribers and patients through an optimized formulary not only reduces harm, but has a true economic impact.
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 an author 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 to ensure what is approved and prescribed to the public is vetted on complete, accurate and detailed evidence.
We encourage the FDA to improve their own FAERS data processes, and to start enforcing the law. 100% transparency on all drug data – it's the public's right and the government's obligation.
Jim Davis can be reached at jim@adverahealth.com
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