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The Corner

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What About a Private Alternative to the FDA?



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Imagine a world where everyone — I really mean everyone — has access to modern, affordable, high-quality health care. In this world, doctors don’t need to beg bureaucrats and insurance administrators for permission to save lives. Entrepreneurs here actively compete to lower prices and invent novel solutions. Imagine, in other words, a world in which our health-care system is dragged out of the Stone Age and into the modern, competitive market economy.

One important step in that direction will be to cut the wings of one of the biggest obstacles of innovations in health care: the Food and Drug Administration. The FDA is the quintessential example of an agency that works by the “precautionary principle” norm. In the name of protecting people from everything at any cost, against their will if need be, it imposes an incredible regulatory burden on health-care innovators, which then translates into higher costs and fewer new products available to consumers. In some cases, the FDA’s intervention in the health-care market slows down access to certain drugs or it makes some drugs and technologies unaffordable to poor people. In extreme cases, it kills people who could have been saved if they had had access to a drug and a technology.

In this morning’s Wall Street Journal, neurosurgeon-scientist and entrepreneur Kevin Tracey puts his fingers on the fundamental problem with the FDA:

Start with the Food and Drug Administration, which places the highest premium on “protecting the public health,” according to the agency’s website. The agency believes this goal is best accomplished through detailed oversight, ponderous review and ultimately control.

That doesn’t work for entrepreneurs and investors, who want rapid returns on what they invest, at a pace faster than what the FDA allows. The pharmaceutical industry seeks large markets with high returns, and the major payers, including insurance providers, require evidence of cost effectiveness. Physicians and other prescribers have limited and dwindling resources to participate in research, and instead are encouraged to push standard treatment protocols, even when they are of questionable efficacy.

And the public, the patients, and the parents and children of the suffering, want treatment to be available, immediate and cheap; free if possible.

As laudable as the efforts by Congress to reform the FDA are, he notes, they can’t achieve what needs to be done to allow tech innovators to work their magic in health care.

The solution, he writes, is a private alternative to the FDA. He explains:

The government and entrepreneurs should be allowed to carve out their own turf and let patients choose their own level of risk.

Consider the case of Goran Ostovich, a burly, 47-year-old truck driver from Mostar, Bosnia. Mr. Ostovich has suffered from long-standing rheumatoid arthritis and needed near-permanent bed rest. With his hands and wrists swollen and aching, he could no longer hold on to a wheel or even play with his small children. He tried a variety of medications. None worked.

When I met Goran at his doctor’s office in 2012, however, he didn’t seem at all afflicted with the disease. That’s because, one year earlier, he had been offered the opportunity to be the first participant in a clinical trial of a new therapy based on my invention. He received a bioelectronic implant and rapidly improved. His mobility restored, he was soon back at work and even sustained an exertion injury from playing tennis.

Since news of this clinical trial’s success became public, people from all over the U.S. stricken with rheumatoid arthritis have emailed, called and sent letters pressing for their shot at potentially effective—but not yet FDA-approved—treatments. Most wrote that they would gladly travel to Europe if it meant they could get access to the device.

That’s exactly the point: Some patients are very willing to take a calculated risk, but misaligned incentives in the industry are driving potential stakeholders with new solutions out of the business.

While the FDA does a commendable job, there is no reason it should have the sole responsibility for access to lifesaving treatment. Institutional review boards and human-subject research protocols provide extremely high levels of protection overseeing clinical trials in the U.S. and Europe. These bodies have weeded out the charlatans in the industry, and the ultimate determinant of success will be patient satisfaction.

The whole thing is here.

A private alternative is based on the idea that we should treat people like adults, often better suited to know what is best for them than bureaucrats in Washington. The bureaucrats who work at the FDA are mostly well-meaning people — some may even be totally benevolent — but they work in an environment that suffers from the same perverse incentives that produced the VA scandal, the CDC scandal, and a raft of other potentially deadly government failures.



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