On August 1, 2016, Dan Leonard, the President of the National Pharmaceutical Council published an opinion piece for Morning Consult, laying out his reasons for FDA to provide guidance on how biopharmaceutical companies can utilize and share real-world evidence with healthcare decision makers. He argues that due to shortcomings and ambiguities in existing laws, the exchange of information is limited, and stakeholders are making decisions without access to all of the pertinent information. His solution is more regulation and guidance from FDA.
We completely agree that the drug industry is one of the last bastions of information asymmetry between buyer and seller. We have been arguing the point for years. However, we don’t share Mr. Leonard’s optimism that more regulation and clarity from FDA would rectify the problem. Under Mr. Leonard’s plan, meaningful drug evidence could be shared with less risk, but that evidence would still be sponsored and driven by the manufacturer, and thus inherently biased. That’s not to say it’s unimportant—just to be taken with the same grain of salt as currently acceptable sponsored evidence.
Mr. Leonard provides five recommendations in his article that center around flexibility of policy, real-world data, and communication to decision makers and patients. However, we argue that while his recommendations are valid, there are fundamental issues that need to be addressed prior to any new policy is enacted.
Fix the existing data transparency problem. Clinical data transparency has been under fire for years. There are documented cases of negative clinical trial results not being reported, leading to organizations like AllTrials.net. Trial end-points are often a moving target, being changed mid-trial, leading to organizations like Compare-Trials.org. And it’s not only manufacturer sponsored research either. As STAT pointed out late last year, most research institutions routinely fail the reporting requirements as well.
Our Advera Health analysts see the blatant disregard for transparency first hand when compiling the clinical evidence database in Evidex. Large data gaps in the ClinicalTrials.gov database require our analysts to pull large amounts of unstructured data from published literature, abstracts, and poster presentations. The scope of the issue has been detailed in a previous article, Chronic Underreporting of Clinical Trial Results.
Furthermore, negative data and important safety issues are often “hidden” in publications, outside of the requirements of reporting laws. While we offer a solution to this issue for our clients, we can’t yet call every healthcare decision maker a client. The lack of full transparency leads to evidence based medicine without all of the evidence. So, before new policy is introduced to regulate the sharing of new and different types of data, we encourage regulators to enforce current policy.
Support the use of independent analytics and tools by healthcare decision makers. Contrary to how Mr. Leonard makes it sound in his article, there are already real-world evidence analytics and tools available to healthcare decision makers. These tools, such as the one provided by our company, allow stakeholders to perform independent analyses on new drugs coming to market, track performance once they get to market, and ensure up-to-date data are always available. However, the insight that is gleaned from these analytics and tools are not controlled by a manufacturer, and thus the conclusions don’t always match the story that their evidence told.
A manufacturer should have the ability to use sound evidence to tell their story, however independent sources of those data should also be supported. This is not just a burden for big pharma to carry. We have seen a culture shift in the past few years where health plans and other at-risk organizations are turning to independent data sources and working on ways to mine their own data for insight. Policy going forward should not only focus on how manufacturers can share evidence, but on ways to support organizations to also look at evidence independently.
Mr. Leonard states, “…the communication of healthcare information is now more important than ever”. We agree, that communication laws need to evolve. However, we also stress that in order to continue to evolve towards a balanced and symmetrical marketplace, the manufacturer cannot be the only source of data.
Improved transparency, enforcement of existing reporting regulations, and support of independent sources of data and analysis are all critical to a fully informed decision making process and true evidence based medicine.
We invite all parties involved to take a closer look at how our company is working to help healthcare decision makers deliver more efficient, high-quality health care through the use of modern data sources.
Feel free to contact me directly at jim(at)adverahealth.com.
Jim Davis, EVP Advera Health Analytics