It has been said there are shortages in this world, but there has never been a shortage of bad ideas. In fact, the opposite seems to be true. Here are three really crummy ideas we should all hope end up thoroughly debunked.
FDA does comparative effectiveness research
We’ve tackled this idea before, but unlike fine red wine, this one isn’t improving with age. The Institute of Medicine released a report recently stating that FDA should “have a more rigorous approval process for new technologies,” arguing that med tech firms “tend not to do comparative-effectiveness studies and, compared to the pharmaceutical industry, invest much less in research and development.”
Aside from the enormous difference in market capitalization between the largest drug makers and the largest device makers, the comment blithely ignores the huge difference in the per-patient cost for device trials and drug trials, the latter of which often require the doctor do nothing more than give the patient a pill. Beyond that, a CE trial for devices would have to be much larger and more expensive, and hence most would never see the light of day.
But let’s not forget this is the same IOM that recommended FDA scrap the 510(k) program and replace it with … well, with who knows what? They never said. They did say, however, that the replacement might employ the notion of a predicate device, which was just brilliant! And let’s not forget that Bill Vodra, one of the boy wonders of the IOM report on 510(k)s, said at a conference that the 510(k) program would have cleared a jumbo jet with a camel as the predicate.
What this says about FDA is unclear, but one thing all this makes clear is that anyone with enough time and money on their hands can get a JD or a PhD and sit on a blue-ribbon IOM panel. I’d rather have a blue-plate special, thanks very much.
Blame the environment for breast cancer
Well, the U.S. government is again bent on destroying cancer by any (absurd) means available, including by spending money on hypotheses such as that breast cancer is caused in significant part by the environment. Anyone familiar with the term “endocrine disruptor” knows what I mean. There has been an ongoing ruckus over these chemical compounds, a list that includes bisphenol A (BPA). All I can say about BPA is that if you ingest enough of anything, it’ll make you sick. The data behind BPA and other endocrine disruptors has been largely inconclusive at best. But let’s not let that trouble us. Heck, it’s only tax money!
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Assume healthcare reform will fix the Medicare cost issue
This is one of those “I have a hunch” observations based on our collective past experience as much as anything else. The problem with this assumption is that similar past assumptions have almost always proven false. For instance, Medicare was projected in 1965 to incur a cost of between $12 billion and $15 billion per year by 1990. The number came in at about ten times that.
At some point, healthcare overhaul might “bend the cost curve” to sustainable levels, but this outcome is a lot more likely to require help from other quarters, such as tort reform, allowing people to go on Social Security without going on Medicare, and means-tested eligibility.
Most people will say none of these ideas is particularly obnoxious, but you’d be surprised at how they’re greeted in some quarters. Still, I predict means testing will be applied to both Medicare and Social Security at some point. It won’t fix either, but I can’t see how either can be fixed without it.