Friday, February 12, 2010

Gingrich & Goodman Idea #10: "Make Medical Breakthroughs Accessible to Patients"

The final "GOP idea" shared by Newt Gingrich and John C. Goodman is to "Make medical breakthroughs accessible to patients".
Breakthrough drugs, innovative devices and new therapies to treat rare, complex diseases as well as chronic conditions should be sped to the market. We can do this by cutting red tape before and during review by the Food and Drug Administration and by deploying information technology to monitor the quality of drugs and devices once they reach the marketplace.
The FDA doesn't get much love from anybody. When it doesn't approve medications or medical devices quickly, it is a behemoth that must be streamlined. But when it makes a mistake, approving a dangerous drug or device, even if the error was caused in part by streamlining the same critics previously demanded. At the far extreme, some call for eliminating the FDA and simply letting the market do its magic - I guess if enough patients die, people will figure out that they don't want a particular medication, treatment or medical device.

With some of the FDA's sluggishness it does appear that a new device or treatment could be a genuine boon to patients, and could potentially decrease medical costs. Consider, for example, the artificial pancreas. The FDA describes itself as having taken a "proactive role" in the development of the technology, but diabetes patients still wait. The FDA cites concerns about safety and the accuracy of sensors - after all, an error in the administration of insulin could be lethal - and that at best an artificial pancreas won't function as well as the real thing. But no question, there are diabetes patients who would accept that risk and find the FDA's caution to be both excessive and frustrating.

But let's take a step back for a moment. Let's assume that the FDA's approval process could be streamlined, such that new devices and drugs could be approved much more quickly without jeopardizing patient health. Although there are exceptions, and the artificial pancreas may prove to be one, how often have new medications and new technologies reduced the cost of health care? Usually they have the opposite effect - investment in new technologies and the high cost of patented drugs and devices push overall healthcare costs up. With due respect for Gingrich's love of science fiction, how does he expect that a proliferation of drugs and devices, not fully tested, will decrease health care costs as opposed to increasing them - not only to pay for the patented technologies themselves, but to treat patients who experience bad outcomes due to errors resulting from an accelerated approval process?

If Gingrich and Goodman have answers then, once again, I expect that this is a proposal that would get broad bipartisan support. Without answers, given their insistence that the reform bill be revenue-neutral, I expect that the GOP will be quick to reject it.

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