Terminally Ill Patients and the Right to Try
29 Jun 2016 Leave a comment
in economics, health economics Tags: drug lags, FDA, invisible graveyard
How many people has the FDA killed today?
04 Jul 2014 Leave a comment
in economics of regulation, liberalism Tags: drug lags, FDA
Beta blockers regulate hypertension and heart problems. The FDA held up approval of beta blockers for eight years because it believed they caused cancer. Dr. Louis Lasagna of the Tufts University Center for the Study of Drug Development estimated that 119,000 people died who might have been helped by that medication.
Clozaril was first approved and used in 1970 in Europe to treat schizophrenics who did not respond to other medicines. The drug was not approved in the United States until 1990 because companies believed the FDA would reject it on the grounds that 1 per cent of all patients who take the drug contract a blood disease. Clozaril has a beneficial effect on 30 to 50 per cent of patients. FDA delay meant nearly 250,000 people with schizophrenia suffered needlessly.
Mevacor is a cholesterol-lowering drug that became available in Europe in 1989 but did not in the United States until 1992. Taking the drug reduced death due to heart disease by about 55 per cent. During that three-year period as many as a thousand people a year died from heart disease because of this FDA delay.
From 1938 until 1962, the FDA had sixty days to disapprove the application of a new drug. If it did not, the drug could be marketed. The system worked without significant incident.
The dead are many but who did the FDA save from unsafe drugs. There is an infallible test. That test is based on the FDA not being infallible.
The FDA must have made some errors and let some unsafe drugs slip through which caused the hundreds of thousands of deaths needed to make up for the deaths – the premature deaths – that were the result of drug delays. What were those drugs that slipped through the net?
via Unpleasant Economists : The Freeman : Foundation for Economic Education.
The economics of the Dallas Buyers Club
15 Mar 2014 Leave a comment
in liberalism, politics - Australia, politics - USA, Public Choice, regulation Tags: AIDS, AZT, Dallas Buyers Club, David Friedman, drug lags, FDA, Matthew McConaughy, Sam Peltzman
Deciding if a new drug is safe is a serious issue. Separate to this is whether the drug is better than existing drugs.
In 1962, an amended law gave the FDA authority to judge if a new drug produced the results for which it had been developed. Formerly, the FDA monitored only drug safety. It previously had only sixty days to decide this. Drug trials can now take up to 10 years.
Who cares if a safe drug works or not? If a new drug does not work or is no better than the existing drugs on the market, the investors in the development of the new drug bear the (unrecoverable) development costs. Capitalism is a profit AND loss system. Losses are a signal that you should try something else.
Sam Peltzman showed in a famous paper in 1973 that these 1962 amendments reduced the introduction of effective new drugs in the USA from an average of forty-three annually in the decade before the 1962 amendments to sixteen annually in the ten years afterwards. No increase in drug safety was identified.
Drugs became available years after they were on the market outside the USA. To quote David Friedman:
“In 1981… the FDA published a press release confessing to mass murder. That was not, of course, the way in which the release was worded; it was simply an announcement that the FDA had approved the use of timolol, a ß-blocker, to prevent recurrences of heart attacks.
At the time timolol was approved, ß-blockers had been widely used outside the U.S. for over ten years.
It was estimated that the use of timolol would save from seven thousand to ten thousand lives a year in the U.S. So the FDA, by forbidding the use of ß-blockers before 1981, was responsible for something close to a hundred thousand unnecessary deaths.”
AZT double-blind trials collapsed in the mid-1980s in the USA because participants sold the drug in the black market.
If memory serves right, Australian drug regulators planned to duplicate these double-blind trials in Australia before approving the drug. Last time I checked, the physiology of Australians was the same as any other human being. What did they plan to find that justified the delay in approving AZT?
The duplicate double-blind AZT trials in Australia were abandoned not because they were mad and evil, but because again the participants sold the drug in the black market. That was to be expected too so the duplicate double-blind AZT trials in Australia in the 1980s were a double evil.
Utopia, you are standing in it! 
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