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Basic failures of government bureaucracy: keeping our food supply safe, approving life-saving drugs

Basic premise of the liberal/progressive movement: Americans need to pay large amounts of taxes in order to allow the government to carry out its mandated functions of keeping us all safe (and here they generally mean things like "safe food," not defense-oriented threats) and maintaining a functioning infrastructure.

Smaller government is a fixation of ninnies, wingnuts, and pumkin-headed spindles.

Right.

Only the problem seems to be that their most sacred cows (and you'll understand why that was a really bad pun momentarily) seem unable to perform, no matter how much money we give them.

I recently documented the fact that (with full Executive and Legislative oversight) the Department of Homeland Security has allowed the number of critical terrorist targets in the US to be increased from an original 160 to over 300,000 (that's one target for every ten people in the country, folks). That explains why Dunkin Donut shops and city fire hydrants have been declared essential to our national security, to the tune of hundreds of millions, if not billions, of dollars.

Or how about the US Department of Agriculture, one of the lead agencies charged with keeping our food supply safe? In 2004 a slaughterhouse company in Kansas, Creekstone, spent $6 million to build its own plant to test every single cow for mad cow disease. There was a two-fold purpose in this. Creekstone was trying to open up the Japanese beef import market (where the law then required every animal to be tested, and thus locked out American beef), and at the same time saw a marketing advantage in being able to advertise its beef as safe to worried consumers.

The USA stepped in and forbid Creekstone to test every cow, using an obscure 1913 law giving it authority over certain patent medicine procedures. Was there something wrong with the Creekstone facility? No. Instead, the USDA argued in Federal court that such testing was unfair to other meat producers, because it created the impression that their product was less safe than Creekstone's. This might lead to other producers being forced to spend money to build their own plants, which for some reason the USDA did not want to see happen.

This, by the way, occurred at a time when virtually every independent scientific expert in the country was deriding the USDA's testing program as worse than useless.

OK, I know, we'll blame this one on Dubya. When's he's out of there it will all be better.

Except that doesn't explain why multiple experts castigate the Food and Drug Administration, over the past forty-plus years, for allowing millions of Americans to suffer and die because of inappropriate testing procedures.

The 1962 Kefauver-Harris amendment to the 1938 Food, Drug, and Cosmetics Act placed so many additional restrictions and requirements on the FDA drug-approval process that, post-1962, the period required to authorize the sale and use of new medications (even those already tested in Europe or Canada to equally stringent specifications) increased from seven months to over eight years by the 1990s!

Does this so-called drug lag produce any real harm?

You bet.

Here are some extracts from the heavily documented Theory, Evidence and Examples of FDA Harm at FDAreview.org:

Deaths owing to drug lag have been numbered in the hundreds of thousands. Wardell (1978a) estimated that practolol, a drug in the beta-blocking family, could save ten thousand lives a year if allowed in the United States. Although the FDA allowed a first beta-blocker, propranolol, in 1968, three years after that drug had been available in Europe, it waited until 1978 to allow the use of propranolol for the treatment of hypertension and angina pectoris, its most important indications. Despite clinical evidence as early as 1974, only in 1981 did the FDA allow a second beta-blocker, timolo, for prevention of a second heart attack. The agency's withholding of beta-blockers was alone responsible for probably tens of thousands of deaths (on this general issue see Gieringer 1985; Kazman 1990).

A chief source of information about drug delay is the Tufts Center for the Study of Drug Development, a scholarly, not too outspoken research center funded chiefly by pharmaceutical companies. Their information is often mined by researchers at the Competitive Enterprise Institute (CEI). The CEI has noted that in recent years thousands of patients have died because the FDA has delayed the arrival of new drugs and devices, including Interleukin-2, Taxotere, Vasoseal, Ancrod, Glucophage, Navelbine, Lamictal, Ethyol, Photofrin, Rilutek, Citicoline, Panorex, Femara, Prostar, Omnicath, and Transform. Prior to FDA approval, most of these drugs and devices had already been available in other countries for a year or longer. . . .

Evidence from the pre-1962 market shows that FDA restrictions have greatly reduced the number of new drugs, and because there was little or no corresponding gain in drug quality, the concomitant mortality and morbidity were unredeemed. The international evidence shows that there has long been a drug lag in the United States, and because Americans have not benefited from the extra "precaution," the concomitant mortality and morbidity are unredeemed. Finally, the off-label evidence indicates that the network of doctors, patients, pharmaceutical firms, hospitals, universities, rating organizations, and so forth is really in charge of defining and judging efficacy and that it functions smoothly and successfully in the realm of uses not approved by the FDA; hence, the mortality and morbidity that result from proof-of-efficacy requirements are unredeemed. All the systematic evidence goes against the coercive FDA apparatus.


This kind of institutional malfeasance goes beyond Democrat/Republican political squabbles: it is indicative of the fact that large-scale bureaucracies--whether governmental or private--have no inherent interest that overrides their own survival and growth instincts.

But, I know, all Libertarians are crazy to point this out.

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