Today marked an amazing milestone for a project I’ve been working on for the past six weeks: the launch of the 2013 Update of one of the biggest authorities in public health: The Priority Medicines for Europe and the World Report.
Priority Medicines is a very well known piece of literature in the field of international health (I’ve even cited the former version in the course of my graduate studies). Systematically outlining the disconnects between research and development objectives of the pharmaceutical industry with the global burden of disease, the report compiles years of research to explain a series of pharmaceutical gaps:
1. There is no existing medicine on the market for a certain condition, due to either market failures or a lack of scientific knowledge.
2. Treatment exists, but is not effective.
3. Delivery mechanisms are inadequate, and medicines are not reaching patients.
Through the nine chapters and nearly 500 pages of the report, experts from all facets of the industry have come together to propose several changes in the current industry pathways. By drawing direct comparisons between the Global Burden of Disease (quantified through Disability Adjusted Life Years), and the roles current research incentives (or rather disincentives) play in making further bottlenecks in the innovative process.
For example, the U.S. Federal and Drug Administration has been very strict in the safety and efficacy requirements for new drugs since the Thalidomide incident of 1961, where thousands of children were born without limbs due to a common medication for sleeplessness that was authorized before being sufficiently tested on special populations such as pregnant women. Since then, the FDA and other major regulatory bodies around the world have boosted safety standards, requiring such extensive clinical data that bringing a drug to market now takes an unsustainable 10 – 15 years and at least 4 billion USD. The report preposes several systematic changes for regulatory authorities to the way pharmaceutical companies approach their research.
My timing with the World Health Organization could not have been more fortunate, though the final stages of the once a decade update for the report was far from seamless. Heightened by last minute ethical disagreements, these past few weeks have been filled with adversarial teleconferences between industry stakeholders.
Although the report is now in public hands, my personal project is just heating up. The work here in Geneva never stops, and I’m sure these next few weeks will continue to challenge and inspire☼
More on it later. In the meantime, it’s time for a nap :)