WHY THE FDA MUST BE MORE OF A HINDRANCE THAN A HELP

In his recent op-ed essay for 'The New York Times' (December 21, 2004), Goozner advances some of the classic myths about government. First, he tells us, "To make rational choices, doctors and consumers need the F.D.A. and other agencies to be independent arbiters of not just the safety and efficacy of new drugs and devices, but of their relative medical usefulness and economic viability." He continues his myth-perpetuation by announcing that "the medical oversight system needs a new ethic-one that scrupulously adheres to a standard that says its studies and decisions have been made entirely free of commercial bias and conflicts of interest."

Our true believer in the power of government to solve all our pharmacological problems quickly gives a hint as to why it is all a dream: "Sadly, that is very far from the situation today. Drug and device companies sponsor most clinical trials; F.D.A. advisory panels are larded with scientists tied to private companies; corporate user fees help finance the F.D.A. that is conducting reviews; doctors get most of their medical information either from sales representatives of drug companies or corporate-sponsored continuing medical education; and the companies are given primary responsibility for post-marketing safety surveillance of their own products."

Goozner mentions these obstacles to the possibility of impartiality and objectivity of government policy-making as if they were something only in place "today." And thus he charges ahead enthusiastically with the na‹ve notion that "To break these ties, there needs to be an independent arm of F.D.A. that contracts with independent clinicians and scientists for the final testing of all new drugs and medical devices." He proposes that "After a company submits its drug application based on safety and early efficacy trials, this arm would design the protocols to learn not just if the new drug is effective versus a placebo, but how it compares to other therapies and how it can be most effectively used. At the same time, the F.D.A. agency would need an adequately financed post-marketing system that would follow through on a drug's safety, using information and financing independent of the drug manufacturers."

These are all pseudo-noble notions and while they fall way short of justifying what the F.D.A. is supposed to be doing at its idealistic best, there is an omission in Goozner's discussion that amounts to out-and-out malpractice: He fails to discuss either the very famous argument of economist Sam Peltzman, of the University of Chicago, concerning the drug lag problem or the Nobel Prize-winning idea of Professor James M. Buchanan of George Mason University called "public choice theory."

Anyone who still has the temerity to propose that government is the solution to problems associated with drug manufacturing and marketing has the moral and professional obligation to discuss these two basic objections to such an idea. The drug lag argument shows that even following the intentions of the legislators who created the Food and Drug Administration, the results are going to be disastrous. Yes, one can always call up such rare victories as the banning of thalidomide (though even this one is no slam dunk when the details are considered). But as Aristotle taught us some 2600 years ago, "One swallow does not a summer make."

In fact, the F.D.A.'s policies produce even greater health hazards than anyone could imagine it averting. The reason is pretty simple: By insisting on certain types of tests for drugs that are being slated for manufacture-routinely requiring the impossible of proving a negative ("No one will be put at risk from this drug")-Americans are often prevented from gaining access to very effective means to fend off life-threatening diseases. The country thus lags behind many others and only those rich enough to visit these others are able to overcome this obstacle to their likely medical recoveries.

The merits of this argument are, of course, in the details. Yet it has gained considerable credibility over the last five or so decades and anyone who promotes greater powers for the F.D.A. needs to discuss it. The same holds for Buchanan's theory of public choice, one he developed with Gordon Tullock in their book, 'The Calculus of Consent' (University of Michigan Press, 1962). In 1985 Buchanan received the Nobel Prize in economics for this work and anyone who is proposing that outfits such as the F.D.A. can escape the inherent problem of bias would have to address his work.

Contrary to the suggestion by all those who propose to solve problems via government-namely, that all we really need is better people and more stringent rules-public choice theorists argues that inherent in the process of government regulation we invariably find the triumph of vested interest. Bureaucrats, including the most honorable scientists who might be hired to work in government agencies, are inclined to bolster their own special purposes and goals-some call this their "selfish interests"-and the way the welfare state works there simply is no way to curtail any of this. The dynamics of the nearly-unbound democratic system are such that government must respond to those in the constituency who exert the most clout. This is the most natural way of its operation. So it is sheer fantasy to hope that new people or rules will manage to circumvent it all.

But, instead of at least hinting at such problems with his proposal, Mr. Goozner charges ahead zealously, failing to raise any of the well-established skeptical concerns with what he wishes for, holding out the myth of government regulators as "independent arbiters."

Source

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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