Drug trials on trial: Is it really greed versus good? – The Globe and Mail

A good analysis about the ethics and risks of compassionate access to experimental drugs, prompted by the campaign for Darcy Doherty and his unfortunate recent death. Quote:

The sad case has given new urgency to a long-standing, gut-wrenching debate: What obligation, if any, do drug companies have to terminally ill people? Should they help very sick individuals even if that could jeopardize clinical trials and delay the introduction of a drug? What about the testing process over all? Why does it take more than a decade and as much as $1-billion to bring a new drug to market? And should these questions be left in the hands of drug companies in the first placeÉ

This case “is sort of illustrative of the tension that arises during drug development,” said David Hogg, an oncologist at Toronto’s Princess Margaret Hospital specializing in melanoma, who treated Mr. Doherty. “We all want things to go really fast and we all want things to be very safe.” But sometimes you can’t do both.

“I don’t think it’s an issue that’s ever going to be resolved completely,” Dr. Hogg said, “because the objectives of pharmaceutical companies and the objectives of an individual patient are not congruent.”

…. “There’s no bad guy here at all,” Dr. Hogg said. Bristol-Myers, he said, was concerned about accidentally hastening Mr. Doherty’s death, “and there’s the potential of doing that. And Darcy [was] worried about not getting a drug that might prolong his life.”

Ms. Cumming, Mr. Doherty’s wife, knew that she was breaking new ground. “I think this is new territory for everyone and that’s why we are really pushing compassionate access,” she said in an interview before her husband died. “It’s hard to see a drug that you know your husband has a really decent chance of responding to is just outside of your grasp. We are just so close and yet can’t get it.”

The question is whether there’s any way to answer that kind of pain and frustration without putting much more at risk.

Drug trials on trial: Is it really greed versus good? – The Globe and Mail.

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