Accelerating Cures: Our Response

Written by Cole Donovan, Director of Policy and Advocacy

Accelerating cures has enormous potential to limit human suffering, and the Stand Up for Science Foundation applauds Representative Auchincloss for his willingness to tackle this particular issue. We’ve chosen to post our comment below, both in the interest of transparency and also to show folks “we’re here”, to give you a sense of what to expect from our organization, and to hopefully shape other organizations’ responses.

First and foremost, the desire to accelerate the delivery and deployment of cures is nothing new. Organizations like the Coalition for Epidemic Preparedness Innovations, or “CEPI,” have spent billions of dollars to demonstrate that it’s possible to develop and deploy drugs much more rapidly. If we had a COVID-19 vaccine in 100 days, it could have saved more than 8 million lives. This is a good thing.

Drug development and clinical trials, especially for emerging epidemics that might originate overseas, require enormous international coordination. It’s not enough for the United States to improve our own clinical development, especially for diseases that start overseas.

Our feedback to the Representative encourages him to do two things. First, rather than reinventing the wheel, coordinating with international organizations that have a complete picture of the cure development ecosystem is absolutely essential. Second, we’re encouraging the representative to be extremely careful not to accidentally introduce new barriers related to data collection and the groups of people who participate in clinical trials.

The first one is pretty obvious: work with experts who’ve devoted their lives toward accelerating drug development. No further explanation needed.

The second one is a lot harder. Global leadership requires more than getting other governments to align with U.S. regulatory approaches. It requires getting other countries to trust we have their people’s interests at heart. Requiring that data be housed in the United States sends the opposite signal. In many situations it doesn’t make a ton of sense to require that U.S. patients be enrolled in trials. Forcing exceptions to be reviewed by the HHS secretary could bottleneck decisionmaking in a health crisis.

I had a front row seat to countries “making things worse” at the beginning of COVID-19. We knew we were going to run into issues with data privacy and collection requirements in Europe, mostly stemming from a lack of trust in U.S. privacy protections.

The issue was political. After the Edward Snowden leaks and social media companies’ role in European elections, Europeans didn’t trust the United States Government to handle people’s personal data. Because our privacy protections weren’t seen as “adequate”, it was a lot harder to share information. Major studies were interrupted because of that lack of trust.

The U.S. and EU worked out a solution, but that solution came after trials for major COVID drugs had already begun, and created a new set of unexpected conditions. A lot of scientists simply didn’t bother.

Things have only gotten worse. Today, as we watch new and deadly epidemics unfold, it’s going to be really important that we rebuild a baseline of trust for people in other countries to work together.

Let’s just say that putting quacks and skeptics in charge of epidemic response while gutting international surveillance capabilities doesn’t help.

There’s going to need to be a concerted effort on the part of Congress and the Executive Branch to rebuild trust in U.S. institutions, and it’s going to take more than speeding up our own system to get there. We’re going to need to spend years listening to our partners and meeting their expectations if we want to put this puzzle back together, and that’s the reason why pushing back on today’s insanity is so important.

Every little thing that undermines trust in the United States is going to get added to the growing ledger of things America has to answer for.

We’re really glad the Representative is taking an interest. We encourage him and his staff to work closely with the experts, coordinate with international partners, and continue to push back against actions that undermine America’s ability to lead in science and technology.

We’ve been pretty busy over here. Our new Assistant Director for Policy and Advocacy, Irene Ngun, is busy working on our input into NIH’s five-year strategy. As Stand up For Science’s new Director for Policy and Advocacy, I’ve been working on the future of scientific governance. Stay tuned.