Can We Still Innovate?

Some say we are close to curing cancer; others that we are close to making cancer a chronic illness. Still others contend that cancer is already a chronic illness. To cure or “get ahead of” cancer, we must fundamentally transform the way we deliver healthcare. It’s not a transformation America is prepared to make. Mark Boguski goes so far as to argue that it’s impossible to innovate healthcare delivery in America. It’s not just words. When his company decided to transform a healthcare system, they looked to Thailand and Japan, not America. There, a universal, private healthcare system built around modern medicine will open its doors in 2022.

What’s the problem? It starts with education. Because we don’t have a healthcare “system” we don’t have a link between invention, practice and education. That means that it’s really hard to change curriculum to accommodate the new technologies. On top of that, as I wrote elsewhere, medical schools have to be accredited by the American Association of Medical Colleges so they also need to keep the AAMC happy. Perhaps as a result, 54% of family physicians (the people you turn to first when you’re not feeling well) “felt they were not knowledgeable about available genetic tests.” Even doctors at large medical centers have a hard time keeping up with the latest treatments. And if your doctor doesn’t prescribe a test or a therapy, you’re not getting that test or therapy.

That’s only part of it. Large drug companies are not innovating. Seventy eight percent of the patents approved by the Food and Drug Administration (FDA) correspond to drugs already on the market. What innovation we do get is funded by public funds or created by small pharmaceutical companies that bring together data scientists, programmers, doctors, chemists, and psychology majors. That’s because publicly funded organizations and small start-ups alike are not set in their ways and, as a result, try crazy stuff. Like training our immune system to fight cancer.

Even so, in 1997, the FDA ruled that no matter who invented a genetic therapy, if it was to come to the market, it had to go through the New Drug Application or the Biologics License Application process. A pharmaceutical company (usually a large company because they have the lawyers and the established relationships with the FDA) has to submit an application to the FDA, the FDA tests it for safety and if it’s found to be safe, it can be marketed.

This makes no sense. The idea behind the NDA process is that a company puts in a lot of money into research, comes up with a drug, the FDA approves that drug and lets the company have a period of exclusivity (12 years for biologics) when the drug company is the only one who can sell the drug. After the 12 years are up, generic companies can compete with the inventor. Even putting aside the fact that large pharma companies hardly invent anything, the whole notion that there can be a generic version of immunotherapy is ludicrous. Immunotherapy teaches your cells or my cells to fight cancer. Is there a generic version of you out there? I hope there isn’t a generic version of me!

I get why the FDA promulgated the regulations. This is our genes we’re messing with. I would like the scientists to get it right. The Food, Drug and Cosmetic Act doesn’t give FDA authority over therapies; only drugs. The FDA is trying to use this outdated authority to keep us safe. They’re trying to fit a square peg in a round hole. That’s a problem. It might also be an opportunity.

There might be a way to solve both the problem of how much these new therapies cost and the problem that there is more than an even chance that our doctors don’t know about the new treatments. Give the FDA oversight of therapies in law. Let any entity (public or private) register its new therapy with the FDA for 12 years. Let the entity (start-up, public hospital, whatever) that creates the new therapy use that time to train others in this new technology. Have the FDA oversee the training and the safety of this procedure and work with other agencies to ensure that this therapy is taught in medical schools. To fund this, let the inventor get 7% of the profits from the new therapy and have the FDA get 3% of the profits. For 12 years.

This will mean that a start-up doesn’t have to get bought up by big pharma to make money or that a public hospital has to sell its invention to big pharma. It will establish a pathway between revolutionary technologies and medical education.  We will thus increase access to breakthrough therapies and incentivize their development. And because we will be creating competition, we may even lower costs.

Of course there are other laws that would have to be changed if we decide to do this. We would (for example) have to change the laws around what therapies have to be covered. Right now, cancer drugs are protected drugs meaning that Medicare and Medicaid have to cover them. So you get cancer, need one of these drugs, and all else fails, you can at least try to qualify for Medicare or Medicaid coverage. But there are no “protected therapies”. As a result, insurers are able to withhold therapies such as life-saving proton therapy and patients have no recourse. So if we go this route, we will have to change the laws to make sure that insurers have to cover these therapies. At least for patients covered by Medicare and/or Medicaid.

Which brings me to a larger point. Because to do all this effectively, we need a healthcare system. Whether it should be a single-payer system like Canada’s or a private universal healthcare system like Thailand’s and Germany’s, I leave to the politicians and us voters. But if we truly want to make it possible to innovate in America, we need a healthcare system that links medical innovation to practice to education.

Or we can go to Thailand.