A few weeks ago, I published a post in this blog, Drug Safety Progressives - The Rise of the Pharmacovigilante. I was blown away by the positive response and resulting discussions. I even received a few requests for the t-shirt shown in the picture, but I’m sorry to say that our business model is based on software-as-a-service, not retail. But I digress… back to the Pharmacovigilantes…
The United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.
I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march. The division was obvious.
In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information.
I originally wrote the post below for the FSR blog. The original can be seen here.
Healthcare systems are generally slow to adopt new technologies. For all the talk about leveraging “Big Data,” the industry has been even slower to adopt analytics to make those data actionable. In fact, not one state Medicaid agency currently uses an evidence aggregation platform with post-approval adverse drug events intelligence when creating preferred drug lists, writing prior authorization criteria, negotiating supplemental rebates, educating prescribers and dispensers, or performing prospective, concurrent, or retrospective drug utilization reviews. This is in spite of the fact that millions of patient lives are put at risk and billions of dollars are spent every year from adverse drug events. Yet there is no mandate to use readily available, reliable data to inform making decisions about prescription medicines.
Fortunately there are the outliers - innovators and early adopters that see things differently. They know that they can make a difference by incorporating new ideas and approaches to improve patient outcomes and their own bottom lines.
Product liability insurers protect pharmaceutical companies from legal actions associated with their drugs. They have a significant economic incentive to scientifically assess and understand the scope of litigation risk. Experienced underwriters use an evidence aggregation platform to better understand if a manufacturer’s drug is causing severe side effects that could lead to potential litigation. They also use an evidence aggregation platform to adopt and employ a simplified and unified process of assessing side effect risk with proven statistical measures via a simple interface that deploys in minutes.
Managed Care Organizations are reviewing drugs well before a product is approved. According to a survey conducted by Dymaxium (the company behind the AMCP eDossier System) and presented in a recent webinar, two out of three healthcare decision makers begin to evaluate a drug at least six months prior to approval. The survey also indicates that the primary source of information that payers are using for these pre-approval evaluations is clinicaltrials.gov (CT.gov), and that manufacturers are not always responsive to requests for information pre-approval.
Drug safety is often equated with post-marketing pharmacovigilance, something that is required by manufacturers only after their drug is approved. But when drug safety data are presented in an evidence aggregation platform there are very strong use cases in pharmaceutical competitive intelligence, health economics and outcomes (HEOR), and R&D. An evidence aggregation platform takes multiple sources of information and boils it down into actionable insight. That insight often has use cases that span all departments and can meet the demands of various priorities.
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, most research institutions routinely fail to meet reporting requirements as well.
Furthermore, negative data and important safety issues are often “hidden” in publications, outside of the requirements of reporting laws and standard practices. The lack of full transparency leads to evidence based medicine without all of the evidence, and makes pharma CI's job of fully understanding competitors’ data especially difficult.
One form of hidden data points are adverse events that are not listed as “serious” in clinical trials because they do not lead to death, hospitalization, or life-threatening situations.