The Propaganda for Reform in Proprietary Medicines, Vol. 1 of 2Council on Pharmacy and Chemistry (American Medical Association)
Science
The Propaganda for Reform in Proprietary Medicines, Vol. 1 of 2
Council on Pharmacy and Chemistry (American Medical Association)
Patent medicines
After the acceptance of Digalen, the therapeutic claims made for it by
the manufacturers increased in extravagance. Meanwhile, evidence was
brought forward by various independent investigators which tended not
only to show that these therapeutic claims were unfounded, but also
to discredit the claim that Digalen contained a principle chemically
identical with digitoxin. In view of the obscurity of the whole subject
of the chemistry of the digitalis principles, the latter claim (that
Digalen was a solution of “amorphous digitoxin”) had been an academic
issue at the time of the acceptance of the product. When, however, the
manufacturers of Digalen sought to mislead physicians by increased and
unwarranted therapeutic claims, the Council felt that investigation of
the whole matter was imperatively demanded to decide whether or not
Digalen should be retained in N. N. R.
The questions at issue were: (1) the presence in Digalen of “amorphous
digitoxin”; (2) the constancy of composition and reliability of action
of Digalen, and (3) the claim that it causes less gastric disturbance
than digitoxin. No satisfactory proof has yet been offered that Digalen
contains “amorphous digitoxin.” The mass of evidence tends to show that
Digalen is not constant in composition or reliable in action, and that,
when given in doses corresponding in therapeutic activity, Digalen
causes quite as much gastric disturbance as the official galenical
preparations of digitalis.
The outcome of protracted negotiations between the Council and the
Hoffmann-La Roche Chemical Works may be summed up as follows: 1. The
manufacturers promise to hold in abeyance the claim regarding the
presence of “amorphous digitoxin.” 2. They refuse to concede the
variable composition of Digalen. 3. They reassert the claim that
Digalen is superior to other digitalis products with respect to
liability to cause gastric irritation and consequent vomiting.
In view of the unsatisfactory character of the reply on the second and
third points, the Council voted that Digalen be omitted from N. N. R.
and that publication of the report on Digalen which appears below be
authorized, as well as of the two reports[26] (A and B) referred to
therein.
[26] These reports (A, first report on Digalen and B, examination of
Digalen Tablets) will be published in the 1914 Annual Council Reports.
A reprint of the entire matter dealing with the rejection of Digalen
will be sent on receipt of a two-cent stamp.
W. A. Puckner, Secretary.
Referee’s Report on Digalen
Because of persistent conflict with Rule 6 (unwarranted therapeutic
claims) and Rule 1 (composition) it is recommended that Digalen be
omitted from New and Nonofficial Remedies; also that a copy of the
report be sent to the manufacturers, and that publication of this
report and the two previous reports submitted to the Council be
authorized.
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