“All who drink of this treatment recover in a short time, except those whom it does not help,who all die.

It is obvious, therefore, that it fails only in incurable

cases.”

--Galen, 129-199 AD

Civilizing Capitalism

The FDA, Business and One Hundred Years of

Regulation

The Grand Bargain

By the 1950s, Smith, Kline had dropped 14,940 of its products, setting aside all its dubious or

worthless chemicals, and instead began to research and sell only

60 drugs.

It made a better profit with a

few, real drugs.

The Scientific

Base

“...Adequate and well-controlled investigations”

by people qualified in science505 (d) 7: 1962

Historical Requisites for Reform

1. news reports outline the problem.

2. Reformers campaign for change.

3. Laws are drafted, debated in Congress.

4. Reform is killed by special interests.

5. A Crisis intervenes (involving children), and reform law is passed.

Back to the 19th Century

“I think something more than 40,000 tuberculars alone have

died in this country who conceivably could have been

saved by a drug that has been used widely in the last few years

throughout Europe.”

---- Ronald Reagan, press conference, American Enterprise Institute, 1975

*When he said it, the drug had already been on the market for several years.

*He said it took more than two years to approve---in fact the approval came

through in five months. The manufacturer was the one who had held back.

*The idea that 40,000 people died because of the lack of the drug was absurd. In the entire decade from 1968 to1978, a total of 28,000 people died of TB in the U.S. There were three effective drugs on the market to treat it. The reason for death in virtually all

cases was that people came in for diagnosis very late in the progress of their

disease, too late for any drug to help.

Tacrine

(Cognex)

“During the seven years it took to approve Tacrine, thousands of Alzheimer’s

patients gradually lost their memories. Nobody knows

how many died.”

----Washington Legal Foundation

Cognitive Cosmetics

Tacrine would not have prevented any deaths. Nor would it have halted the progress of

Alzheimer’s disease. The United States was the first to approve the drug; many countries

did not follow its example.

The FDA sometimes allows early access to treatments that are only marginally useful. Such a case was Tacrine. The drug causes

liver damage in many; it does nothing to treat the underlying disease and very little to treat

the symptoms.