Wednesday, April 13, 2016

Ethical Considerations in Immunotherapy Clinical Trials

I read an article in Time Magazine recently called “What if your immune system could be taught to kill cancer? Inside the brutally selective, hugely expensive, lifesaving trials of immunotherapy” by Alice Park. This article touched on several topics from class, including drug discovery and development, personalized medicine, and ethics that I’d like to elaborate on and discuss.

The idea of immunotherapy in this article circulates around a treatment known as adoptive T-cell transfer. With this therapy, a patient’s own T-cells are modified in a lab so that that when they are infused back into the patient, they have the ability to identify and attack cancer cells. When you’re talking personalized medicine, it doesn’t get more “personal” than this. The patient who received this treatment from the article was in a phase 1 safety study, and this is not yet approved. Some of the potential side effects include fever, hallucinations, coma, and death.

Patients have to be extremely sick and in most cases, failed all other treatments on the market, before they can try adoptive T-cell transfer. According to the article, this is making some patients very upset. It’s hard enough to endure failing multiple treatments, and to look for a clinical trial as a back-up plan that might improve your condition makes things even more difficult. Every clinical trial has a set of inclusion and exclusion criteria, but as the chief medical officer of the American Society of Clinical Oncology puts it,

“It used to be that if you had lung cancer, you could find a clinical trial for people with advanced lung cancer… Now, advanced lung cancer isn’t enough. You have to have advanced adenocarcinoma lung cancer with an ALK mutation that only occurs in 2% of lung cancers.”

The patient discussed in this article was a man named Mike Hindt. Mike was diagnosed with metastatic pancreatic cancer and qualified to enroll in an immunotherapy trial after failing treatment. He was in the trial for a grand total of six weeks before the drug company, Acerta Pharma, told him he could not continue with it because the lesions on his liver were growing faster than the trial’s protocol. What are people in Mike’s situation left to do?


I don’t personally think that clinical trials should be portrayed as an answer to patients who have failed all other treatments since the goal is to examine the safety and efficacy of a new drug before it is approved for widespread use and it’s possible they won’t qualify. But once you get into a trial – in a situation where there is no other treatment option, is it ok to take away the treatment when it looks promising because the patient doesn’t fit the criteria of the study 100% of the time? Financially it’s a good option, but is it right ethically? I’m not quite sure how to answer this question myself. I think it comes back to the idea of whether or not we believe that health care is a right and not a privilege. Does this patient have a right to receive this treatment? As you can probably guess from my answers in class, I don’t think that he does. However, there’s something about the fact that he already started the treatment and had to stop it that bothers me. We’ll never know if this patient could be saved if he had continued the treatment, but I think it’s a possibility even though over time he did not fit the study’s protocol.

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