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Healthy Skepticism Library item: 16915

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: news

Comer B
Sanofi card trick draws warning
Medical Marketing & Media 2009 Oct 28
http://www.mmm-online.com/sanofi-card-trick-draws-warning/article/156355/


Full text:

A promotional card for Sanofi Aventis’s Uroxatral omitted indication and risk information, and also used outdated product labeling, according to a DDMAC warning letter dated October 23 and posted online yesterday.

The front side of the “tent card” reads “Always in the bathroom…especially at night?” and “Relief begins with U,” without providing a full indication for the drug. “These statements misleadingly imply that Uroxatral is approved for…any condition that keeps the patient in the bathroom, such as overactive bladder. Uroxatral is only approved for use in the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH),” the letter said.

Although risk and indication information was printed on the back of the card, DDMAC determined that viewers are unlikely to see it. “The tent card is designed to be adhered to a flat surface (e.g., a pharmacy counter) and as a practical matter, viewers of the front side of the card are unlikely to be able to view the back side of the card once it is stuck in place,” according to the letter.

DDMAC noted a statement on the front of the card directing viewers to safety information on the reverse side, but said the omissions “cannot be corrected” by referencing the back of the card. Information on the back of the card also failed to include an “important warning and precaution regarding Intraoperative Floppy Iris Syndrome (IFIS),” the letter said.

As a result, Sanofi must halt dissemination of the cards, and provide a written response to the letter by November 6, 2009.

 

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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