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Summary: A research project between Frederick Research and the Cicero Institute will explore novel healthcare policies that are based on competition and informed choice. Two of the policies to be explored include state-based alternatives to the FDA such as automatically approving treatments that have been deemed safe by British health authorities, and insurance reimbursement of procedures based on precision medicine case studies and electronic records instead of decade-long group clinical trials.
As I write this post, I am bouncing between states to see surgeons for a sleep disorder because antiquated regulations ban doctors from video consultations across state lines. I have to fly to world-class surgeons outside of my home state of Texas, even though they’re perfectly capable of giving me a consultation over FaceTime.
For the past few years, I’ve undergone four surgeries to essentially reverse the orthodontics procedures I had as a child, when it was standard practice to treat crowded teeth as normal, and to extract molars, then bind them with braces. Now as an adult, I need (quite expensive and painful) procedures to expand my jaw in ways that dentistry shrunk as a kid.
I have been told by multiple licensed professionals that there’s emerging evidence of how modern diets and dental procedures may be related to the population-level rise in my particular jaw deformation; the healthcare science we take for granted today may seem archaic tomorrow.
I learned personally what many economists and healthcare experts have been saying professionally for years: we need ways to inject competition, humility, and informed choice into the regulatory system.
There are a few specific reforms I’ll explore during the course of the joint project between Frederick Research and the Cicero Institute on informed choice-based healthcare. Most of these will center around alternatives to the FDA as the only organization authorized to approve treatments and alternatives to clinical trials as the only source of worthwhile evidence.
First, while the Food And Drug Administration (FDA) is given federal supremacy over the approval of drugs and devices, they often make decisions that are at odds with other well-respected expert bodies.
For instance, economist Alex Tabarrok notes one bizarre example where Princeton University had to scramble for emergency FDA authorization to vaccinate students against an outbreak of a deadly Bacterial Meningitis strain; the vaccine was already approved in Europe and recommended by the U.S. Centers for Disease Control and Prevention (CDC) but held up by the FDA.
Examples like this have motivated calls for “international reciprocity.” If a drug is good enough for doctors in Great Britain, then it should be good enough for doctors in Texas.
The American medical system is littered with life-saving treatments that worked overseas years before eventually meeting the FDA’s scientific standards. These treatments were, in fact, saving lives, but America banned doctors from prescribing them until they met the most stringent scientific standards of multiple, multi-year randomized control trials.
Unable to wait, wealthier Americans fly to luxurious treatment clinics for life-saving procedures while those with fewer resources languish until academic results are published.
An individual state, such as Texas or Arizona, may decide that these foreign treatments should be available to local residents and automatically adopt reciprocity with that nation’s approved treatments. A competition-oriented regulatory framework would permit doctors and patients to follow the lead of other reputable medical experts, such as the CDC or a European regulator. If Congress does not act, states should be able to approve such treatments unilaterally.
Second, as diagnostics become more advanced, treatments become more personalized, complicating the old gold standard of randomized clinical trials. Novel drugs can be tailored to a patient’s unique genetic code. In personalized medicine, group trials are inappropriate because the total population is of size 1; the patient is both the test case and target consumer.
Again, this topic is personal: my doctors have been using advanced imaging to tailor my surgical plan. Published clinical trials on my particular surgery aren’t all that useful because the procedures and samples studied in the published literature may not reflect my unique circumstances.
In the old regulatory framework, randomized, placebo-controlled trials over a decade would theoretically produce evidence addressing all the possible concerns even the most skeptical and risk-averse doctors might have about treatment.
But, now, personalized treatments will be as varied as doctors themselves. There will be robust disagreement among doctors, as there has always been in practice. The source of such treatments will be case reports, electronic medical records, and Internet databases.
America does not have to chart these reforms alone, or even for all states at once.
Japan, for instance, has implemented new expedited licensing mechanisms of investigational treatments for frontier “regenerative” medicine that places more emphasis on data collection and patient education, rather than restriction and consensus.
The Netherlands has a thriving mental health tourism industry of people seeking treatment with Psilocybin-assisted therapy with medical practitioners. Texas recently passed legislation to help expedite the FDA-approved research trials of Psilocybin to treat veterans with PTSD, but this therapy could still be years away from federal approval.
States, doctors, and entrepreneurs are all trying to address time-sensitive patient needs—and they can’t wait for slow federal bureaucratic processes.
Frederick Research and the Cicero Institute will explore these public policies, among others, to create healthcare frameworks that are as adaptable and responsive as new healthcare technologies—aligned to a north star of advancing scientific progress through informed choice.