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The FDA: government inteference in health care
Posted by: Jon Henke on Wednesday, March 05, 2008

Megan McArdle...
A number of liberals are angrily defending liability by arguing that the FDA is underfunded, incompetent, the victim of regulatory capture, and staffed by life bureaucrats more interested in preserving their jobs than protecting the public health. Quite possibly true. Only one question: if it doesn't keep us safe, and the liability system does, then why do we have the regulatory agency in the first place?
Here's another thing to think about: A few months back, many were outraged when a young girl, Nataline Sarkisyan, died after the administrator of her insurance plan, Cigna Healthcare, did not approve a liver transplant procedure until it was too late to save her life. Many Lefty bloggers (and Michael Moore) were outraged, though they got some of the facts wrong and the situation wasn't nearly as clear as they seemed to think.

This raises some more questions:

Do advocates of universal health care think cost/benefit resource allocation decisions will no longer happen under universal health care? Do those advocates believe nobody will ever be denied any medical care for any reason? If they disagree with those decisions when the government pays the bills, where will they take their business?

Finally: Cigna Healthcare denied one procedure that had a chance of extending a life. But the FDA routinely delays and denies thousands of medical treatments based on potential risks and uncertainties far less than in the case of Cigna and Nataline Sarkisyan. Far more people are denied treatments by the FDA, but where is the outrage from the Left over government interference and obstruction in the health care decisions?

As McArdle says, we already accept that the process is manned by imperfect people with perverse incentives. Yet we have given them a monopoly over decisions about our medical treatments. That is absurd and inconsistent with the kind of reaction we saw in the Cigna case.
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Previous Comments to this Post 

If they (the lefties) thought past their simple notions of fairness and justice, the cognitive dissonance would probably render them comatose.

Written By: Grimshaw
URL: http://
Do advocates of universal health care think cost/benefit resource allocation decisions will no longer happen under universal health care? Do those advocates believe nobody will ever be denied any medical care for any reason?
This is the key point i always try to get across to people. Its not about who runs healthcare, its about how much it costs. and changing the payer does not reduce cost.
Written By: josh b
URL: http://
Well Josh, the government’s going to pay for it, see? Simple!
The government has lots and lots of money!

I don’t get why you guys want to make this so hard to understand.
Government pays the bills and no one will be denied health care.
Written By: looker
URL: http://
The FDA approval process, which as I understand it is fantastically costly to drug companies, amounts to protection for those drug companies from competition. The drug companies complain about the cost of developing a drug and getting it approved, but think of the advantages for them, given the barrier these costs create for small firms that want to enter the market. They might have great ideas, new approaches, but not the capital to meet the onerous approval process. Niche drug development by entrepreneurs is probably all but impossible.

I’ve always said, and by always I mean for thirty years, going back to when I was a screaming liberal, that the most frightening prospect for American society is for there to be a merger between the American medical establishment and the federal government. It will be like a merger between the Clingons and the Borg, where an incredibly bad attitude and resistance being futile will create the most universally loathed and feared institution in our daily lives.

Go back and take a look at that thing that Hillary proposed in ’94, for instance. It’s available online. That would have made members of the old Soviet Politburo gag.

In the de facto merger between the FDA and the drug companies, whatever antagonisms they pretend to have, makes them both worse.

And I hope Michael Moore, when he needs a liver, has to try to get one out of the American "universal" health care system, which will be so efficient that it will refer patients directly to the cemetaries.
Written By: Martin McPhillips
The FDA’s perversities extend beyond drugs. I used to work for a medical equipment manufacturer, and the FDA came in an did a big audit. After they were done, they forbade the company to ship any new product until certain problems were remedied (reasonable), but some of those problems were with the *paperwork*. And until that is fixed, the company can’t develop the next version of the product.

Yeah, the company’s revision-control system was a freaking mess, but it seems to me that the FDA should evaluate only the equipment and any other customer-facing products (documentation, etc.) to make sure that you can’t accidentally kill or injure anyone with it. Period.

After that, if the company’s internal processes are a dog’s breakfast, that’s the company’s problem. If the processes harm the bottom line or the product’s quality, they’ll get dinged for it in due order by the faulty machine that doesn’t pass inspection or by cost overruns. Or both.

In the meantime, the company still, after two years, is not working on the new version, and they’re bleeding millions, what with all those mechanical, electrical, and software engineers obsessing over jots and tittles.

Fortunately, the company was bought by a behemoth that can well absorb the loss (and pass it on to the customer), but as Martin says, this kind of tomfoolery has the dual effect of shutting out the little guy and raising costs all around.

The primary purpose of government agencies such as the FDA is to increase their reach and influence, and once their tentacles are squeezed into a particular crack, there’s no getting them out.

Like a triggerfish wedged into a coral niche, you can’t get it out without killing it first.
Written By: dicentra
This is the key point i always try to get across to people. Its not about who runs healthcare, its about how much it costs. and changing the payer does not reduce cost.
No, it’s about who runs it. In a free market, the patient runs it, and since he searches for value, costs will go down.

If the government pays, the government runs it, and the patient gets the service the government grants at a cost determined by how much government allocates and by the government processes put in place to attempt to determine proper access to healthcare.
Written By: Don
URL: http://
The FDA’s role is a complex one: it must ensure the safety of available medical products while also allowing the influx of new therapies to help patients. Unfortunately for various reasons, the FDA has decided to err on the side of inaction and CYA by preventing the approval of new devices and drugs. In the past 5 years, applications have doubled while approvals have halved.

A lot of good drugs and niche drugs — the "orphan" drugs we always hear pharma critics decrying the absence of — have died in the application process because it was not financially sound to pursue more tests. I can think of 3 such instances off the top of my head. One was a relatively simple compound to prevent hyperphosphatemia in patients with chronic renal failure. To boil it down, this drug would have given patients the chance to take a pill rather than drink 3 liters of a phosphate-binding slurry before each meal (or the resultant osteoporosis). The FDA insisted on a barrage of extra tests to bolster the already adequate safety profile. In the end, it wasn’t worth the cost of additional research and re-application to produce a drug that could only help a few thousand patients a year.

Such a conservative position is all well and good if the regulatory agency is charged with public protection at the expense of an superfluous product — such as roller coasters. But would you really want such a risk-averse agency deciding whether you should be able to take a chemo drug that only has a 15% chance of shrinking your pancreatic tumor? I think some patients in Britain are already seeing the tragic error of such a ways.
Written By: ck
URL: http://

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