Biomedical Engineering Reference
In-Depth Information
21. See A. Leslie Florence (1960).
22. See W.G. McBride (1961).
23. See also Steven Spencer (1962). Also Rock Brynner and
Trent D. Stephens (2001).
24. See 21 CFR 312.23 “Investigational New Drug
Application,” §50.20 “General Requirements for
Informed Consent,” ∫312.23 (a)(6)(iii)(b) “The
name and qualifi cations (curriculum vitae or other
statement of qualifi cations) of each investigator,” ∫ 56
“Institutional Review Boards” (IRB), and ∫ 56.108(b)
(1), ∫ 312.53(c)(1)(vii), and ∫312.66 on AEs.
25. The critiques of Sinclair's topic by a leading meatpacker,
Armour, were published in a series of articles in the
Saturday Evening Post
; collected in J. Ogden Armour
(1906).
26. Upton Sinclair, as quoted in “Worked on President's
Sympathies - Sinclair,”
New York Times
(29 May 1906).
27. See also Gabriel Kolko (1963).
28. According to Dr Morris Fishbein, editor of the
Journal of
the American Medical Association
(JAMA), “the solvent,
diethylene glycol [. . .] rather than the sulfanilamide was
responsible” for the poisoning; see “Drug Preparation
Blamed in Deaths,”
New York Times
(19 October 1937).
This statement was made a few days after the fi rst reports
of poisoning; the editorial was published as “Deaths
following Elixir of Sulfanilamide - Massengill,”
Journal
of the American Medical Association
, Vol. 109 (23
October 1937), p. 1367. The AMA later published a
report on the investigations; see Paul N. Leech (1937).
29. See James H. Young (1983).
30. See “Manufacturer Accused,”
New York Times
(12
June 1938).
31. See Arthur Daemmrich (2002).
