By Ronald L. Trowbridge, Ph. D.
Volunteer Adjunct Scholar
Abigail Alliance for Better Access to Developmental Drugs
In August, we (Abigail Alliance) lost our case in the D. C. Circuit Court of Appeals. We are appealing this decision to the Supreme Court. We argue that terminal patients with no options left but death have a constitutional right to promising investigational drugs already proven safe enough for further testing on people, in the care of a qualified physician.
Recently my partner Steve Walker and I conducted painstaking research that disclosed appalling findings. We collected data from the FDA, the American Cancer Society, and from a number of research oncologists expert in their respective fields of cancer indication and corresponding drug response. We focused on the 12 promising investigational drugs that the Alliance had pushed for early access over the past five years, all of which were subsequently approved by the FDA.
In sum, these 12 drugs—had they been available to people denied entry to clinical trials—would have helped well over one million people live extended lives, anywhere from a few months to many years.
Generally, our critics cite four lines of opposition:
1. Our proposal would open a floodgate to quack drugs on the market. Not true for two reasons: one, the promising drugs we promote must clear at least Phase I of FDA testing and control; two, a qualified physician must officially prescribe these drugs for individual patients.
2. Our proposal would cause a maelstrom of confusion in record-keeping, given responses to limited patients in clinical trials and responses of unknown thousands of terminal patients to investigational drugs. But if we can get a man to the moon, we can design software systems that will separately track clinical-trial patients as well as terminal patients getting investigational drugs. Establishing such dual systems will take diligence, especially at the outset, but it’s doable and worth the effort: extending human lives.
3. Our proposal will harm some terminal patients. This argument is incredulous, because it says to the terminal patient: “This drug might not be safe for you, so we won’t let you take it. You can go ahead and die, but you’ll be safe from the drug.” As Orwell said in 1984 on doublespeak, war is peace, hate is love, and terminal death is safety. Let the decision to take a promising investigational drug be between the qualified physician and patient, informed of the risk.
4. Our proposal will discourage patients from entering clinical trials. Three responses here: one, our proposal speaks only of terminal patients denied access to clinical trials. Two, patients will seek the best odds for survival, and why not? Three, the FDA acknowledged in its own legal brief: “the number of persons who are accepted for participation in clinical trials is relatively small . . . . The number of qualified would-be participants may exceed the number of spaces in the trials.”
This fall the ACCESS Act will be introduced in the House and Senate legislating our proposal. The Act will permit promising investigational drugs, still regulated by the FDA, to be prescribed to terminal patients.
Dr. Trowbridge was Chief-of-Staff to Chief Justice Warren Burger and the Commission on the Bicentennial of the U. S. Constitution. Before that, he was appointed by President Reagan, with unanimous confirmation by the U. S. Senate, to a top-level administrative position at the United States Information Agency. He holds a Ph. D. in English from the University of Michigan.
