Government-run health care: A glimpse of the future

Posted by Marc Hodak on March 26, 2010 under Government service | 3 Comments to Read

Boston Scientific, maker of those ultra-cool, implantable defibrillators, made some minor changes to the way they manufactured them.  There was nothing wrong with the devices under the old manufacturing method–they just felt that they could do better.  Unfortunately, the company ran afoul of the bewilderingly complex FDA documentation rules that require any manufacturing changes to be reported to them.  As a result, Boston Scientific has been forced to recall a bunch of perfectly good, life-saving devices, and submit their manufacturing changes for FDA review before being allowed to resume manufacturing.  FDA review times run from 8 to 30 days.

Boston-Scientific tried to calm their medical customers (and investors) by hinting that the urgency of this matter should warrant a shorter review period.  During this period, doctors are doing without the device (“Hang in there Charlie!  We’ll get that thing implanted in the next few weeks.”), and Boston-Scientific is losing $5 million a day.  If ever we needed those high-priced government services, this would be it, right?

FDA officials said in an interview that they have given Boston Scientific’s applications a preliminary look and the submissions appear to be in order.  But the officials said the agency hasn’t begun an in-depth review of the material and the company will have to wait its turn.

Boston Scientific’s filings are “in the queue, and we’re going to take it when it comes up,” said Gladys Rodriguez, an enforcement director at the FDA’s Center for Devices and Radiological Health who is involved in the review.  “At this point, we’re not expediting.”  The FDA has 30 days to do a review, Ms. Rodriguez said.

Translation from bureaucrat lingo: “We can’t be bothered.”  I mean, c’mon, it’s not like its their lives or money on the line.

  • Boston Scientific defibrillator recall said,

    […] Marc Hodak wonders about the FDA and its sense of urgency. […]

  • Patty Berg said,

    How can industry that creates miracle drugs and devices, and whose attitude is “how can we help you?”have so much less esteem in the media than an organization whose attitude is “wait your turn?” I don’t get that.

  • GregS said,

    To answer Patty’s question: because industry is motivated, at least in part, by the profit motive, whereas government is motivated by the motive of “public service”. In the altruist morality that most people accept, profit is selfish and therefore evil, while public service is selfless and altruistic, and therefore good. So no matter how much good an industry actually does in practice, it is still regarded as morally suspect and potentially depraved, while no matter how lazy, incompetent, and indifferent government bureaucrats are, they’re regarded as morally upright and trustworthy.

    There’s a moral bias against industry and towards government, and nothing that industry does can remove that. The altruist believes that someone motivated by the profit motive will do evil to make a profit if the opportunity arises. So no matter how many years a company has been in business performing honestly, the altruist still regards the businessman as a crook waiting for an opportunity to commit a crime. On the other hand, the altruist sees government as being motivated by a desire to serve the public good, and sees cases where it doesn’t as merely being isolated incidents that have no larger implications for the moral standing of government.

    The answer to this is to replace the altruist morality with one that champions rational self-interest, like that of Ayn Rand.

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