In light of recent events in my personal life forcing uncharacteristic delays between posts, I'll review briefly what I've discussed so far before continuing the discussion about the FDA's recent revocation of approval Avastin for treatment of breast cancer.
The FDA is charged with many tasks, including (1) ensuring the safety and efficacy of new treatments, (2) taking steps to speed the development of better treatments and (3) providing science-based information to help patients make wise decisions.
To bring a new treatment from initial testing to FDA approval requires a huge investment of time, expertise and money . A wide variety of people influence the fate of a new treatment, but the FDA approval committee has the ultimate say -- whatever the advisory committees recommend.
From my vantage as a physician and patient (currently in remission from a type of cancer with no known cures), I want the FDA approval process to...
- Protect me from treatments with unacceptable risk-benefit ratios
- Make it easier for promising research to move forward
- Speed the availability of improved treatments
- Make it possible for me to receive treatments my oncologist judges can benefit me -- off-label, if necessary
I don't want the FDA's decisions to be based on:
- Input from professional lobbyists, marketing executives or politicians
- Testimony of impassioned patients who recovered on treatment, but whose recoveries were not due to the treatment (i.e., a "true-true-and-not-related" event)
- The desire to provide -- or not quash -- hope, even if it's the hope of wishful thinking, not the hope born of scientific study