When the House passed the 21st Century Cures Act in a groundbreaking 344-77 vote, the decision felt like a defibrillator, deploying life-saving shocks to the healthcare system.
Critics may say that Cures is bad for patients, but with an increased focus on precision (personalized) medicine, innovation incentives for uncommon diseases, and, most importantly, better support for National Institutes of Health (NIH), Cures could breathe new life into the rare disease community.
At least, that was the case until Cures went to the Senate.
Now, Cures fights for its life under the knife of the world’s worst surgeons, and it may flatline because…
- Fiscal Conservatives Are Literally the Worst
Despite frankly nauseating increases to defense spending over the years, congressional conservatives love to pull the plug on other government funding.
Cures included.
Fiscal conservatives are feeling rather faint about the mandated annual funding increases for the NIH.
Yes, the NIH, which many of you rely on, not only for care, but for breakthrough research.
The NIH has faced massive funding depletion in the past decade, and Cures had a provision to address this. It was, in fact, one of the few provisions to receive support from Cures’ critics and celebrators alike.
But Senate conservatives, apparently, didn’t read the chart.
Without the NIH funding increases, you have to ask, is there much of a point to the bill? Especially since…
- There are Risks to Patient Safety
One of the most noteworthy aspects of Cures is its reinterpretation of drug approval requirements. The benefits of this are, in theory:
- an expedited approval process,
- better inclusion of patient perspectives, and
- fewer treatments abandoned prematurely
This sounds great for people with rare diseases, so what’s the downside?
Answer: A serious decrease in patient safety.
Cures would consider things like “evidence from clinical experience” efficacy data in addition to, I don’t know, actual efficacy and safety data?
It’d be like the 1960s and thalidomide, but the FDA would no longer have a metaphorical Dr. Francis Oldham Kelsey keeping dangerous drugs and medical devices from the market.
While people with rare diseases—who have lived without effective treatments and are desperate for more options—may feel the risk is worth the potential benefit, keep in mind…
- You Could Lose Consent
There’s a tricky little part of Cures that may fly under the radar.
In cases where clinical trials present “minimal risks,” patient consent could become optional.
Worse, there’s no specific language saying what exactly constitutes “minimal risk” or who makes that decision.
If that doesn’t concern you, it probably should.
The United States doesn’t have the best track record with informed consent in medical research, so for Cures to have vague, problematic language within that vein feels like moving backwards in a bad way.
Still, like many recent reforms, Cures is a huge step in the right direction, especially for rare diseases.
But with the best parts of the bill being lobotomized within the Senate and problems still abounding, is it worth passing?
Is Cures a healthcare miracle or just more snake oil?
They’re questions Congress probably won’t answer any time soon. With debates over federal budgets and trade agreements taking up time, looks like we may have to wait until the 22nd century for Cures.
With the debate just starting, you have plenty of time to brush up your politics. Read more about the 21st Century Cures Act in the Senate here!
