Is it okay to let people believe that they are going to be alright when their chances of getting by are slim? An article in the NY Times discusses just that. How does one approach the ethics of informed consent in early-phase clinical trials that only toxicity and dosing and offer insignificant, if any at all, benefit to those involved?
On woman the author of the article talks about is a woman with melanoma in her late 30s, and a mother of three. When the author met her she was coming to her third clinical trial. The growth of her cancer had slowed briefly after one of the other trials, but since then she has been hospitalized numerous times, suffered serious bloating, had a punctured lunch, overwhelming fatigue, and two intractable infections. Surprisingly, she had an amazing sunny disposition.
When being briefed for the Phase I trial that would essentially test to determine the safest maximum dose of a new drug, her response to the doctors was, “Haven’t we talked about this enough?...I’ve been through this before. I know what I am getting into.” Then her voice lowered and she said, “I’m a mother. I would do anything for a little extra time with my children.”
But did she know what she was getting into? Generally fewer than 5% of patients in these clinical trial benefit from it. It could potentially take away the little time she has left with her children. And it did. She did not respond to the treatment.
A study was conducted in several early-phase cancer trials in which the patients said they understood that the purpose of the trial was to advance research, not heal them. Despite their understanding of this, the patients had a sense of what the researchers called “unrealistic optimism.” A majority of the patients believed that the drug would heal their cancer and they would benefit.
So what do we do with this unrealistic optimism? Would we know it when we see it or would we be too engulfed in it to even know it is there.
Personally, I do not see anything wrong with this unrealistic optimism. Sure, people may think that they will be the one in a million that would benefit from something like an early phase clinical trial.
I would not be hesitant to say that it would be wrong to take that last bit of hope away from them and interrupt their unrealistic optimism.