The Life Raft Group’s stand on placebo- use in clinical trials for cancer patients was recently highlighted in the November/December issue of European magazine, “Cancer World”. Here are a few excerpts (the full article can be found at www.cancerworld.org/magazine:
“With regard to the criteria presented in the ASCO paper to justify placebo-controlled trials, [Scherzer] poses this question: who decides? Who decides that such a trial design is necessary on this or that methodological criterion? And who decides that the patients exposed to placebo are not placed at an unacceptable risk?
“If you propose giving a placebo to terminally ill patients to demonstrate that their disease progression or death rate will be greater if they are not given the drug, you must assume the burden of demonstrating that there are no alternatives, and that patients on the placebo arm really won’t suffer serious irreversible harm,” says Scherzer.”
A Conflict of Interests
“Scherzer puts it this way: “We find ourselves comparing the needs of those who are exposed to a placebo against those who might benefit in the future. We agree with ethicists who state that you’ve got to look at it in the present tense. Good outcomes, no matter how noble, cannot justify research that fails to protect the health and safety of those who participate, particularly terminally ill patients who may have no access to other treatments…”
“[Dr. Peter] Reichardt puts it this way: “If patients argue ‘we don’t want a placebo trial,’ this could result in the trial not happening… Patients have to understand that no trial means no further improvements, no new treatments and no future achievement.” Given the element of conflict of interests in this situation, it might be argued that the only ethical way to proceed would be to allow the patients some say in the way that phase III trials are designed. This is something Reichardt strongly advocates. “Once a new treatment has shown activity in an early trial, then we can sit down and discuss how can we bring this drug further. Then we start by asking: What kind of trial would be needed to prove efficacy? What would be the target population? What would be acceptable to the regulators? What would be practical with respect to numbers? What would be acceptable to sponsors in terms of money? What would be acceptable to patients as potential candidates for the trial? At that moment the voice of the patient groups could be necessary.
“They can bring their arguments, and learn what it means if they say ‘we cannot accept this’, and we will say, ‘OK then we cannot do the trial’, and then they would say ‘we want the trial’. And then we can start discussing how to go about this.” The suggestion provokes a certain nervousness among many sponsors, who fear that patient groups could end up holding a gun to their heads. Yet far more damage is already being done by some patient communities who effectively sabotage trials they don’t like, by refusing to enroll. There has to be a better way. “Nobody has a greater interest in fast-tracking testing and approval of new drugs than a cancer patient has,” says Scherzer. “The whole process would ultimately be a better process if patients like us were seriously engaged in the decision-making process from the very beginning. We might help come up with a protocol that everybody could live with. When you leave out the guinea-pig – in this case the patient – I do think that is by its nature