Mike's Blog

Lots of action two weeks ago as Congress labored to finalize FY24 funding. The bottom line, or end result, for the CTSA Program is a 0.0% increase relative to FY23, and while that may not sound good, it represents a better than best case scenario our budget people were painting for us for the last several months. Any sequestration possibility (due to the Fiscal Responsibility Act) appears off the table for now. NCATS is now in a position to move forward with implementing full year funding plans. Please bear in mind that with budgetary certainty occurring this late in the fiscal year (the end of March is the halfway point in our fiscal year), there will be increased pressure on grants management personnel at NCATS to get everything out the door by 9/30/2024 and they will also be restoring prior awards issued at 90% during the CR. 

I suspect most academics are familiar with the panoply of statistics detailing how the US has dropped in terms of overall population health; this latest poll provides additional insight into how the general public perceives the US healthcare system overall. Bottom line – 70% feel “failed” by the US health care system with more than half assigning a grade of ‘C’ or worse (A-F scale); quite distinct from the likely grade distribution at your institutions. Furthermore, a number of specific concerns are cited such as overall affordability as well as access to insurance coverage and understanding that coverage. When pressed on specific failings, they cite wait times for an appointment, insufficient focus on preventive services, and lack of local providers. On the plus side, two-thirds feel that their engagement with a trusted health care provider is valuable for improving health, highlighting the importance of trustworthiness.

Drugs prices, a big piece of affordability concerns, have garnered quite a bit of attention with several pharmaceutical companies now suing the US Government over Medicare drug price negotiations. At the same time, several states are taking action with seven currently having established state boards to review drug prices. Amgen has elected to sue Colorado asserting that its board conflicts with federal law. Philadelphia is suing eighteen pharmaceutical companies alleging collusion with regard to insulin price inflation, while the states of California and Indiana are doing something similar but adding in several pharmacy benefit managers (PBMs) to the mix. While engagement with the legal community may at some point result in some resolution to pricing concerns, this approach will not address the broader issue of drug price determination, especially for newly approved drugs (and one drug at a time is not very efficient). 

And insulin is not the only drug garnering attention. This graphic from the Visual Capitalist website shows the price of an EpiPen in the US is over three times more expensive than the next most expensive nation (Japan). Vox had an article last year ago detailing all the sordid history. Both insulin and EpiPen have been around for decades with little to no changes in their production or overall cost of goods. As such, it’s hard to envision how any targeted research activity could dramatically impact final drug prices when astronomical price increases have been occurring just over the past decade. Pipettes and case report forms won’t solve this issue.

Lastly, PBMs had quite a bit of attention from Congress in the last several years, but the bulk of proposed reforms have largely ended up edited out of any potential legislative actions. In Washington, it’s easy to recognize when certain industry sectors are concerned with possible reforms as they populate our local airwaves with descriptions of how they are contributing to economic growth and world peace. Somewhat emboldened, PBMs have continued to refine their strategies that ultimately confound developments (in one case, biosimilars) that should, in the long run, lead to lower drug costs.

All of these issues are easily dispensed with as ‘above my paygrade,’ but given the fragmented and balkanized nature of health care in the US, factors beyond the peer reviewed literature informing future clinical guidance are negatively affecting the ability of CTSA translational science activity to positively impact US health care and health care delivery. CTSAs are best positioned and need to be focused on reimagining health care and health delivery to step away from the current treadmill we find ourselves on. We need to be discussing these issues in addition to all the fantastic science and medicine we are developing. We should not be asking how people will afford the next generation interventions we create, but rather how we can make those interventions accessible to everyone that would benefit from them, and cost is only one factor that influences accessibility.

Genuine scientific progress is a slow climb, which requires a stable

society to support thinkers and theorists over many generations. 

-Peter F. Hamilton, Pandora's Star