Mr. Epstein, the James Parker Hall Distinguished Service Professor of Law at the University of Chicago and the Peter and Kirsten Bedford Senior Fellow at the Hoover Institution, has consulted extensively for the pharmaceutical industry. His book on the industry will be published next year by Yale University Press.
Good article by Walter E Williams. The FDA will be afraid to approve drugs even if the pharmaceutical industry is able to afford to make them.
http://www.townhall.com/columnists/walterwilliams/ww20050810.shtml - Making Intelligent Errors.
Food and Drug Administration (FDA) officials, in their drug approval process, can essentially make two errors. They can approve a drug that has unanticipated dangerous side effects (type II). Or, they can disapprove, or hold up approval of, a drug that's perfectly safe and effective (type I). In other words, they can err on the side of under-caution or err on the side of over-caution. Which error do FDA officials have the greater incentive to make?
If a FDA official errs by approving a drug that has unanticipated, dangerous side effects, he risks congressional hearings, disgrace and termination. Erring on the side of under-caution produces visible, sick victims who are represented by counsel and whose plight is hyped by the media.
Erring on the side of over-caution is another matter. A classic example was beta-blockers, which an American Heart Association study said will "lengthen the lives of people at risk of sudden death due to irregular heartbeats." The beta-blockers in question were available in Europe in 1967, yet the FDA didn't approve them for use in the U.S. until 1976. In 1979, Dr. William Wardell, a professor of pharmacology, toxicology and medicine at the University of Rochester, estimated that a single beta-blocker, alprenolol, which had already been sold for three years in Europe, but not approved for use in the U.S., could have saved more than 10,000 lives a year. The type I error, erring on the side of over-caution, has little or no cost to FDA officials. Grieving survivors of those 10,000 people who unnecessarily died each year don't know why their loved one died, and surely they don't connect the death to FDA over-caution. For FDA officials, these are the best kind of victims -- invisible ones. When an FDA official holds a press conference to announce its approval of a new life-saving drug, I'd like to see just one reporter ask: How many lives would have been saved had the FDA not delayed the drug's approval?
The bottom line is, we humans are not perfect. We will make errors. Rationality requires that we recognize and weigh the cost of one error against the other.
On a much smaller level I know where the author is coming from. A couple of years ago, Glaxo and other producers of asthma medications began phasing out the inhaled versions of Serevent, a wonder-drug that had kept me asthma-free for more than four years, replacing it with a dry-powder "discus" from which the medication needs to be forcefully sucked in to the lungs. It's nasty and ineffective. What's more, Glaxo had the nerve to declare, on its website, that they had withdrawn the inhalant-based form of the drug "to save the ozone layer."
I can truly pity someone who has come to depend on the availability of a miracle drug that treats pain and enables him to live a normal life, only to have that drug made suddenly unavailable through a caprice of government. It's positively cruel.
