Biomedical Engineering Reference
In-Depth Information
Another episode involves thalidomide, which was
manufactured and marketed in Europe by Chemie Grünenthal
of (West) Germany as a tranquilizer in the late 1950s, and
was used to relieve morning sickness. Soon thalidomide was
associated with peripheral neuritis. A letter from Dr Leslie
Florence to the
British Medical Journal
suggested that “these
symptoms could possibly be a toxic effect of thalidomide.”
21
Next, a letter from Dr W.G. McBride was published in
The
Lancet
suggesting that thalidomide, when used for morning
sickness by pregnant women, was accompanied by a pattern
of severe birth defects.
22
Finally, thalidomide was withdrawn
from the West German market because of safety concerns.
Thalidomide was not commercially distributed in the United
States during this episode, although it was distributed for
clinical trials.
23
As a consequence of the thalidomide tragedy, the Kefauver-
Harris drug amendments to the Food, Drug, and Cosmetic
Act were signed by President John F. Kennedy on 10 October
1962. These regulations mandated an Investigational New
Drug Application (IND) for the trials. Moreover, the
regulations include informed consent of subjects of clinical
trials, qualifi ed investigators to conduct the trials, Institutional
Review Board (IRB) approval of changes to a study protocol,
and reporting of adverse events (AEs).
24
Further episodes might include Tylenol tampering (1980)
and, if there is a desire to highlight current events,
Salmonella
contamination (1990s; today).
A second thread
immediately follows the historical
summary. This thread treats each of the episodes as the
occasion for continuous improvement - problem
identifi cation, investigation, root cause analysis (RCA), and
remediation through corrective action and preventive action.
That thread can familiarize the new employees with regulated
industry's approach to continuous improvement and risk
