Date:    Sun, 26 Aug 2007 11:29:16 EDT
From:    Gary Takata <GTTakata@AOL.COM>
Subject: OFF TOPIC: DRUG APPROVL

Drug Approval
As researcher Guy Faguet, Ph.D., pointed out in his book The War on Cancer
last year, it is a fallacy to believe that traditional chemotherapy has
succeeded in reducing the number of deaths from advanced cancers. But often, FDA,
under pressure from industry and patient advocacy groups, has approved new
anticancer drugs based not upon evidence that they prolong survival but upon changes
in surrogate endpoints. In this way, temporary decreases in tumor size or
fluctuations in the serum level of a particular marker have become convenient
substitutes for objective demonstrations of survival benefit.
To show that a drug temporarily reduces the size of a tumor is relatively
quick and straightforward. To prove that a drug safely and reliably prolongs life
may require years of careful observation and follow-up if it can be done at
all. This substitution has sometimes confused patients about the actual
benefits of a proposed treatment.
To be fair, there have also been certain notable milestones during this
protracted campaign. There was justifiable optimism when the FDA gave approval in
May 2001 to Gleevec, among the first of a new generation of targeted drugs that
selectively attack certain cancer cells.
I was at the meeting where the pending approval of Herceptin was announced.
There was euphoria among the gathered oncologists. Here, at last, was a drug
that could be used against advanced breast cancer, a mAb that would destroy only
those cells that overexpress the human epidermal growth factor receptor,
HER-2/neu.
To be sure, these were elegant drugs, a far cry from the crude mustard-gas
derivatives and antimetabolites that ushered in the golden age of chemotherapy.
Yet most of the targeted drugs that followed have, so far, failed to live up
to expectations. For a start, these are no magic bullets. Targeted drugs are
not particularly effective when given alone. Even when given alongside standard
chemotherapy, their benefit is often only modest.