Saturday, October 25, 2014

Ebola Won’t Wait for the FDA

Just as fear of Ebola gaining a foothold in the United States in Dallas seemed to be passing, a new case has appeared in New York City. Even if we are so fortunate that no further cases result from this one, the underlying problem will still remain, namely, that many thousands of new cases of Ebola are occurring in West Africa, where its incidence is accelerating.  So long as this is true, it is simply not possible to avoid new cases coming in from abroad, even with the most stringent bans on travel from West Africa. Indeed, even if for a time the disease did not enter the United States again, but merely spread throughout the Third World, that process would create multiple new sources of contagion and, to protect itself, the US would have to impose corresponding additional travel bans. Unless the United States, or the United States in combination with the world’s other advanced economies in a position to cope with small numbers of cases, is able to put itself in a position in which it could effectively close its borders to the rest of the world, the only long-run solution for Ebola is to bring the disease under control in West Africa and wherever else it might appear.

In other words, what is needed is one or more effective cures for Ebola and low-cost, reliable methods of stopping its spread. Unless and until this can be done, the whole world remains at risk of being ravaged on a scale exceeding that of the Black Plague in the 14th century. With today’s highly interconnected global economy, Ebola has the potential to infect practically every one of the world’s more than seven billion people. With a mortality rate of seventy percent, that implies a potential for approximately five billion deaths.

And Ebola is not the only disease that threatens mass death. There are also various strains of flu and other respiratory illnesses. No less frightening is the fact that existing antibiotics tend to lose their effectiveness as bacteria become resistant to them, with the result that there is a continuing need for new antibiotics in order to in order to stay ahead of the changes in bacteria populations and thereby avoid losing the benefit of many of the medical advances made in the last century.

It is impossible to meet such threats under today’s governmentally imposed FDA regimen, in which it typically takes more than twelve years to bring a new drug from the laboratory to the market and requires an investment ranging from several hundred million to more than a billion dollars. Indeed, it appears that there could already have been a cure for Ebola if its development had not been been stifled by this regimen. According to The New York Times,Almost a decade ago, scientists from Canada and the United States reported that they had created a vaccine that was 100 percent effective in protecting monkeys against the Ebola virus.” But, as The Times put it, “The vaccine sat on a shelf.” It sat on a shelf because of the prohibitive costs imposed by the FDA on the development of new drugs.

The FDA regimen that we have for the development of new drugs was established for the intended purpose of making new drugs safe and effective. But its actual effect has been to leave us in a position in which we have drugs of zero effectiveness because those drugs have been prevented from even existing in the first place, and in which we are all terribly unsafe because of the absence of those drugs. The effect of the FDA’s regimen has been to prevent the development of the medicines on which countless lives depend.

It is true that about fifty-five years ago the FDA, by refusing to approve the use of Thalidomide as a tranquilizer for pregnant women, prevented a substantial number of babies being born with severe birth defects. It may also be true that in keeping as many new drugs off the market as it has, it it has also succeeded in preventing other, similar disasters. Of course, if it kept all new drugs off the market, there could be absolutely no disasters caused by new drugs. The disaster, the far greater disaster, would then be the absence of new drugs. What the FDA has achieved is precisely a substantial movement in that direction. It protects us by preventing us from taking the risks inherent in progress. This is not protection, but a formula for unprecedented disaster. In the face of such a tradeoff, the United States and the rest of the world would be safer without the FDA.

To have a chance of overcoming Ebola and other potential public health calamities, the FDA must lose its monopoly on deciding what medicines can be produced and sold in the United States. Short of its being abolished altogether, which would be the best solution, its powers must be reduced to that of an advisory body only, in which case, while it might continue to approve or disapprove of drugs, no one would be compelled to follow its decisions. Then we would have a fighting chance to once again make the world safe from plagues.
*Copyright © 2014 by George Reisman. George Reisman, Ph.D. is Pepperdine University Professor Emeritus of Economics and the author of Capitalism: A Treatise on Economics (Ottawa, Illinois: Jameson Books, 1996). See his author's page for additional titles by him.  His website is and his blog is  Follow him on Twitter. 
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