Workable Alternatives to Cruel FDA Policies
Regarding the thesis of your March 6 editorial "Drug Reckoning," that the FDA "has an opportunity to extend and improve" the lives of many people with fatal or degenerative diseases, my wife Pamela's example is a case in point. She died March 7 of cancer; her story needs to be told.
Imagine that your wife has terrible cancer, all chemotherapy drugs having failed her. The oncologist then tells you that there is a trial drug on the shelf in the pharmacy down the hall that is working remarkably well in countering your wife's particular kind of cancer -- but she can't have it because the FDA won't permit it. You wonder in disbelief as to what kind of misanthropic contrivance is controlling things at the FDA. You are told that it has to be this way so as not to violate the purity of statistical analysis.
But if science can put a man on the moon, it surely can arrange for statistical analysis, which identifies people as numbers, to work alongside clinical evaluation, which identifies people as mothers, sons, husbands, daughters.
Or imagine that your child has cancer and is accepted on a drug trial program, where 50% of the cancer victims are unwittingly put on a sugar pill.
My wife had terminal non-smoker's lung cancer. On May 25, 2005, her oncologist, having treated her with a variety of chemotherapy drugs that all failed, was about ready to throw in the towel, mentioning palliative hospice care. The doctor then suggested one last ditch effort -- Iressa. A miracle followed: Her tumors shrank; her chronic, debilitating, morphine-treated pain ceased without trace. This happy condition lasted for seven months, when Iressa finally failed her.
But on Sept. 15, 2005, the FDA took Iressa off the market.
When I recall that the FDA removed a drug that worked, that the drug had demonstrably helped 10% of lung cancer patients, that the decision for its use no longer remains one between oncologist and patient, and that some 15,000 annual lung cancer victims can no longer get the merciful help my wife did, my heart and mind cry out that such FDA prohibitions are outrageous and unthinkably cruel.
As C.S. Lewis once observed, bad acts are usually performed by people "with clean fingernails working in well lit offices."
Sens. Sam Brownback, James Inhofe, Johnny Isakson, George Allen and Jeff Sessions have introduced S. l956 to stop these cruel FDA policies and to offer workable alternatives. There are two seminal components of the bill: One, "Tier I approval shall be primarily based upon clinical evaluation, not statistical analysis." Tier I initial approval is designed to make promising new treatments available to terminally ill patients while they are still alive. The program would allow drug sponsors to sell an investigational drug (a drug undergoing clinical trials in humans) to patients with life-threatening illnesses who have not been able to gain entry into a clinical trial.
Two, the bill would "prohibit placebo-only or no-treatment-only controls in any clinical investigation . . . with respect to any life-threatening condition or disease." No one, by analogy, would think to test a new defibrillator by using one that works on 50% of patients against one that doesn't work on the other 50%.
I suspect that most people, though knowing that cancer is ubiquitous, believe that it will happen to the other guy. Then it strikes them or a family member and, as Dr. Johnson observed about a man about to be hanged, "concentrates the mind wonderfully."
The issue has been introduced in Congress, with hearings to come. Readers of this page wanting to help should write their representatives in Congress. May the mercy of my wife's example help others.
Ronald L. Trowbridge, Ph.D.
Adjunct Scholar
Abigail Alliance for Better Access to Developmental Drugs
Arlington, Va. |
