There's no point in pretending that healthcare is a straightforward proposition in the modern world, but it is nonetheless interesting to bear witness to the associated rhetoric, some of which we may be forgiven for thinking is more than a little disingenuous. But ego and self interest are fun ingredients in this healthcare recipe, no? Read on to see what sort of rhetorical flourishes health care has wrought recently.
L'etat c'est who?
A recent series of Twitter exchanges dealt with the proposition that sugary drinks are creating health care havoc and thus, "we should remove them from the food supply," a statement attributed to Dariush Mozzafarian of Tufts University. My first reaction was to ask which "we" we're talking about. The answer inevitably becomes "we = government," because doctors do not yet run the joint, however dismaying this might be to these utterly benign social engineers of academe.
I also pointed out in this exchange that this discussion invokes the broccoli debate, which may strike some as farfetched, but ask yourself how most Americans would have reacted 20 years ago if someone had predicted that government would require us all to buy healthcare coverage on pain of financial penalty (or as Supreme Court Chief Justice Roberts might say, it's a tax and a penalty).
Most might have said that's a bit outlandish, but here we are. And it's no stretch at all to say that banning sugary drinks leads, with relatively little effort, to mandating a whole host of "healthy practices" and a ban on some other behaviors. The micromanagers among us might find that sort of thing appealing, but it's also a great way to alienate the population entirely.
One gets the sense that those who advocate such measures – which are designed to save we the ignorant masses from ourselves – truly believe that such things would never boomerang back on these healthy elites. Don't bet on it. And don't just assume your prescriptive social engineering dictates will actually work. They don't have that great a record in the U.S., after all.
Cures and the power of the people
We feel ennobled when we advocate for the patient, and FDA has indeed gone to some lengths to give patient advocates more than just looking-through-the-keyhole access to the agency's regulatory review process. Congress is getting in on the act, too, via the 21st Century Cures bill. The funny thing about all this is that FDA seems more subject than ever to "people power" and the whims of Congress, and the results might not please those very patients who are clamoring for more from FDA.
The influence of patients on FDA decision making has a history going back a few decades to the AIDS crisis, but an interesting piece by John Carroll of FierceBiotech adds another layer to the story. Carroll points out that flibanserin, the libido drug for women, had failed at its first FDA advisory hearing, although the sponsor, Sprout Pharmaceuticals, managed to come away from a recent hearing with an 18-6 win. FDA has apparently been accused of sexism because there are a number of libido-enhancing drugs available for men while Sprout's offering would be the first for women.
Three physicians, including a woman, opined recently in the Journal of the American Medical Association that the data for this drug are less than compelling, and they make note of an intensive lobbying effort dubbed "Even the Score" to prod FDA to approve flibanserin. Will women end up regretting this? If so, the blame will be placed entirely on FDA. Those who advocated for this will disappear into the night and they'll let FDA take the blame should this product wreak havoc on patients.
In any event, 21st Century Cures legislation is even more the subject of numerous homilies thanks to passage of H.R. 6 in the House, including by those with a lot to gain. In its desperation for a bipartisan marshmallow roast, Congress is now in full Pampalona mode, and FDA may fall under the sway of these magical 21st Century incantations despite that the legislation gives the agency little more than half the money it will need to move this program along. This does not even begin to address the load the Cures program would impose on the Centers for Medicare & Medicaid Services to review the avalanche of biomarkers that FDA presumably would validate.
We've seen medical stampedes before, but what's disturbing is that they seem more commonplace nowadays, and are coming from an ever-expanding pool of parochial interests. It's not an encouraging sign for the rule of common sense.