Healthy Skepticism Library item: 10214

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Warning Letter to Enzon Pharmaceuticals re Abelcet (Amphotericin B Lipid Complex Injection) Marketing
: US FDA 2007 May 21
http://www.fda.gov/CDER/warn/2007/Abelcet_wl.pdf

Abstract:

…The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a flash
card (ABL 100-059-0806) for Abelcet (Amphotericin B Lipid Complex Injection) submitted by Enzon
Pharmaceuticals, Inc. (Enzon) under cover of Form FDA-2253. The flash card is misleading because it
presents unsubstantiated superiority claims and overstates the efficacy of Abelcet. Thus, the flash card misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a), and FDA implementing regulations. Cf. 21 CFR 202.1(e)(6)(i), (ii), (vii), (x), (xviii); (e)(7)(i). These violations are concerning from a public health perspective because they suggest that Abelcet is more effective than has been demonstrated and encourage its use before other therapeutic options when it is a second line agent…

Notes:

Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Abelcet_Promo.pdf

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909