"The War In Medicine"
Continued from last post.This is what the FDA says, on its own web site, about the
approval of a chemotherapy drug: Iressa:
"Accelerated approval is a program the FDA developed to
make new drug products available for life threatening diseases
when they appeared to provide a benefit over available therapy
(which could mean there was no existing effective treatment).
Under this program, Iressa is approved on the basis of early
clinical study evidence (such as tumor shrinkage) suggesting
that the drug is reasonably likely to have a valuable effect
on survival or symptoms. The approval is granted on the condition
that the manufacturer must continue testing to demonstrate
that the drug indeed provides therapeutic benefit [i.e. tumor
shrinkage] to the patient. If it does not, the FDA can withdraw
the product from the market more easily than usual.
How many clinical trials were performed with Iressa and
what did they show? The study on which the FDA based it approval
included 216 patients, 139 of whom had failed treatment with
two other chemotherapy treatments. In this trial, approximately
10% of patients responded to Iressa with a decrease in tumor size.
The sponsor also presented to the FDA the results of two
large (about 1000 patients each) clinical studies with Iressa
as initial therapy for lung cancer. In these studies all
patients received the standard combination chemotherapy and
were randomly given, in addition, either Iressa or a placebo.
In these studies there was no effect of Iressa on survival
[versus the placebo], time to further growth of cancer, or on
tumor size." (underscore added)
FDA at: http://www.fda.gov/cder/drug/infopage/iressa/iressaQ&A.htm
In other words, in two large studies this drug demonstrated
absolutely no increase in survival of cancer patients. It was
approved because in other trials 10% of the patients had a
decrease in tumor size.
Income for the 98% that fail in Their Internet Business.
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