Experts call for stricter regulations in clinical trials of new drugs
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When most people learn about the results of clinical trials for new medicines, it's either because something very good or very bad happened.
Last year that was illustrated when Dendreon's prostate drug Provenge was approved in April by the U.S. Food and Drug Administration because clinical trials went well, and five months later Eli Lilly infamously had to pull its Alzheimer candidate drug semagacestat because test subjects using it were actually getting worse -- putting both in the news.
"There seems to be two narratives people can handle: Experiments are dangerous and you shouldn't take part, or experimentation is the engine for the next great wonder drug," said Alex John London, an associate professor of philosophy at Carnegie Mellon University who is the co-author of an article in the current issue of the journal PLoS Medicine that looks at this and related issues with clinical trials. "What we need is a more even set of expectations."
That's important, Mr. London said, because if people believe there are only two possible outcomes at either extreme, they might not be willing to participate in clinical studies.
"If people don't participate, studies don't happen," he said.
Mr. London and his colleague, Jonathan Kimmelman, an associate professor in the biomedical ethics unit at McGill University in Montreal, co-authored the article titled, "Predicting Harms and Benefits in Translational Trials: Ethics, Evidence and Uncertainty."
But while arguing that our expectations of clinical trials need to be more realistic and informed, Mr. London and Mr. Kimmelman also believe that the trials themselves need to be proposed, and run, more rigorously.
The article -- which Mr. London sees as "taking part in a wider conversation" with researchers, funders, review boards and other stakeholders -- goes right at what they see as some of the problems in both pre-clinical animal-based trials, and the transitional, first-in-human clinical trials where so many proposed drugs fall apart.
First Published March 14, 2011 12:00 am
