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Healthy Skepticism Library item: 11368

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: Journal Article

Ratain MJ, Cohen EE.
The value meal: how to save $1,700 per month or more on lapatinib.
J Clin Oncol 2007 Aug 10; 25:(23):3397-8
http://jco.ascopubs.org/cgi/content/full/25/23/3397


Abstract:

Drug labels (ie, package inserts) must be approved by national regulatory agencies (eg, US Food and Drug Administration), and are the product of a negotiation between the drug’s sponsor and the regulators. Labels are intended to provide important information for prescribers, pharmacists, and patients regarding the drug’s indication(s) and toxicities, but also include information regarding the drug’s pharmacokinetics, which may not be of interest to most prescribers.

However, the label for lapatinib1 (approved by the US Food and Drug Administration on March 13, 2007) includes a number of pharmacokinetic details of high interest to both prescribers and patients. A most notable finding-also presented at the 2007 meeting of the American Society for Clinical Pharmacology and Therapeutics2-is that the bioavailability of lapatinib is greatly increased by food, especially a high-fat meal…

Keywords:
MeSH Terms: Administration, Oral Clinical Trials Drug Administration Schedule Drug Interactions Drug Labeling Drug Packaging Eating* Economics, Medical Humans Quinazolines/economics* Quinazolines/pharmacology Time Factors Substances: Quinazolines lapatinib


Notes:

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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