The father of my high school girlfriend was not shy about issuing startling proclamations designed to stun the emotionally vulnerable (e.g., the teenaged me). I fondly remember one such broadside: "I must say," he told me, "that in my dating days, I never once asked a girl out who didn't say 'yes.'" Even as a callow youth, I knew the answer to his hollow boast: He simply hadn't asked out enough girls.
Years later I found that economists had formally proved this maxim: If you're living in a world of zero failure, you're an underperformer. Virtually every important action in life involves educated guesswork. Too few chances reliably translate into too few victories.
The Food and Drug Administration is an inglorious case in point. For years the FDA has confronted two types of disaster when sanctioning medicines. Type I: The FDA approves something for use that proves harmful. Type II: The FDA denies (or delays) approval of something that is beneficial. It is an ugly trade-off because good people will die either way.
Unfortunately, the FDA has treated this excruciating balancing act as a regulatory no-brainer: Test everything until there is virtually no chance that it will be harmful. (Read: Minimize Type I error, forget about Type II.) Indeed, the FDA defines safety as the absence of poisonous drugs.
The best academic research suggests more chances would save a large number of lives. The FDA's certainty about approved drugs has, on net, killed many hundreds of thousands because the agency, in effect, isn't asking out enough girls.
Why not? Fear of rejection. In a young boy's life, that is a profound motivator. So too in the life of a federal bureaucrat. Dr. David Kessler, George Bush's gift to the Clinton administration, presides over the FDA with an eerie extremism: We will approve no drug before its time. The politics are not subtle. Type I deaths result in headlines reading, "FDA-Approved Drug Kills Pregnant Mother, Congressional Hearings Slated." Type II deaths don't generate headlines, or even little blurbs. There are no visible victims to lay on the regulator's doorstep when potential beneficiaries are only statistical probabilities.
Now comes reform. The Clinton administration has overruled the FDA and declared that it will speed anti-cancer drugs to market by forcing pharmaceutical companies to prove merely that the drugs shrink tumors. Previously, long-term studies were required showing that anti-cancer drugs actually worked as hoped. I only wish that all of our loved ones had lived to see this day.
It is utterly remarkable how the issue has been caricatured, yielding a clue as to how such appalling public policy can metastasize, untreated, for decades. The Washington Post reported, "Conservatives have been sharply critical of the FDA...." How odd to paint the opponents of regulatory overkill as "conservatives," particularly since the most fossilized bureaucratic processes are walling off new treatments and possible cures. And one must be blind not to have caught the out, rage of the hippie-dippy holistic medicine crowd, irate over FDA initiatives to regulate access to vitamins.
The reform adopted by the Clinton administration was one explicitly recommended by the Council on Competitiveness headed by Vice President Dan Quayle. That proposal died via guilt by association. Congressional Democrats demonized the council as a shill for Big Business. People, on net, continued to die.
Even today, the FDA's unrepentant Kessler, admonished by the Clinton policy wonks, has learned not a thing. According to the Post: "'Faster drug approval inevitably heightens risks,' said FDA Commissioner David A. Kessler. In 11 accelerated approvals by the agency so far, he said, 'We have not made a mistake,' but he warned that 'One day we're going to make a mistake.'"
I want to slap the good doctor and bring him to his senses. His boastfulness regarding zero rejections - merely embarrassing in other venues - is killing innocents. Is it utopian to expect our public servants to be capable of distinguishing between the fantasy of risk-free decision making, and the reality of calculated trade-offs in treating devastating illness?
Hear me now, Dr. Kessler: People with cancer are already a fair way out on the risk axis. They are wise to try the unknown.
Your fixation on Type I errors - perhaps the product of bureaucratic cover-your-ass syndrome? - may not be shared by a good and decent woman, in the golden years of her life, faced with a malignant bile-duct tumor rampaging through her liver. If she would not force her medical gamble on others, will you not grant her the dignity to simply wager what's right for her? If she understands that speedier approvals for cancer drugs will lessen risks when the risk of having cancer is factored in, can you?
Contributing Editor Thomas W. Hazlett (email@example.com) teaches economics and finance at the University of California, Davis, and is a visiting scholar at the American Enterprise Institute. The story of his mother's battle with cancer, including a trip to Japan for an advanced chemotherapy not available in the United States, was detailed in the November 22, 1993, issue of Forbes.
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|Title Annotation:||Food and Drug Administration drug standards|
|Author:||Hazlett, Thomas W.|
|Date:||Jun 1, 1996|
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