Biomedical Engineering Reference
In-Depth Information
ethylene glycol. As a byproduct of the RCA, Samuel
Massengill himself was charged with mislabeling and
misbranding the Elixir and fi ned $26 000.
30
The thalidomide tragedy can be considered an example of
corrective action. In (West) Germany, a pediatrician named
Widukind Lenz began to suspect that thalidomide was
associated with a dramatic increase in birth defects. Lenz
presented his fi ndings at a medical conference in 1961. This
account was picked up by a widely read newspaper,
Welt am
Sonntag
(26 November 1961), which called for the
withdrawal of the drug. Under pressure from (West) German
government offi cials, while still contesting the fi ndings,
Chemie Grünenthal withdrew thalidomide from the German
market a few days later. Further evidence accumulated and
the public outcry increased. This lead to criminal indictments
fi led in 1967 against Chemie Grünenthal offi cials. The trial
lasted three years. It fi nally ended when the company agreed
to establish a substantial fund to provide for the victims of
thalidomide, and the defendants were released from further
liability.
31
This is an example of a corrective action, where
steps are taken (establishing the fund for the victims) to in
part remedy the problem (the administration of a dangerous
drug during pregnancy).
The heroic role of a FDA medical offi cer, Frances Kelsey,
to prevent thalidomide marketing in the United States
represents a somewhat more oblique instance of corrective
action. When Wm. Merrill Co. submitted a NDA for
thalidomide to the FDA on 12 September 1960, the
documentation included evidence of drug safety based on the
distribution of the drug in Europe. Frances Kelsey and her
colleagues at the FDA noted omissions in the application.
Merrill responded to requests for further evidence. As Kelsey
continued to delay approving the application, awaiting
further safety evidence, Merrill became increasingly
