House, MD is a great program for discussion about medical ethics, or bioethics. And the scenario I presented in last week’s post is rife with interesting twists and turns. We can see the following: Foreman convinced Thirteen to enter a trial in which he was one of the co-investigators because he is falling in love with her and wants to give her a chance to live a longer life. To do so, he has to manipulate her emotionally, because she was initially not interested in being in the trial. To do so, he arranges to bring Thirteen into contact with a woman suffering a far more advanced case of Huntington’s, meaning he had to manipulate that patient’s schedule. Thirteen catches on to this, and because of bleed-over from a patient she is involved in treating, whose condition has taken its toll on his family, she decides to end her relationship with Foreman. When she returns for her next treatment, she finds the same woman patient she had seen before, but very much improved. She accuses Foreman of bringing her to manipulate her, but Foreman lies by telling her he did not know what drug the other woman was getting, was not in charge of scheduling, and did not do it- we later learn he did do all of this. House knows, but House also does nothing about it. And the nurse unblinds the treatment regimen that Thirteen is getting. So we see violations of medical ethics by Foreman, the nurse, and House. Foreman is now aware that Thirteen is not getting the active treatment, but is getting the placebo. This is not going to end well.
All research projects have protocols that dictate how they are to be conducted. And all trials are based on something called clinical equipoise, which is a foundational setting that says that we do not know which of the treatments will have better improvement. If we do not start with this at baseline, ethically we cannot do the trial, because if we know that one treatment is better than another we cannot knowingly enter people into the trial knowing that some will be given a less effective treatment. Part of this also involves ensuring that research participants have an equal chance to be in either groups, and in our informed consent documents, we will tell them what we believe to be the risks and benefits of participation. What we will not do is tell them that they will categorically receive personal benefit; we can’t. Often, the only benefit will be the knowledge that they contributed to scientific information that may benefit others.
When patients believes that their involvement in a trial will personally benefit them, and that the doctors involved are doing everything they can on their behalf, they are said to be suffering from the therapeutic misconception. That is because in a research project, the investigators cannot do everything that would be done were we seeing this person as a patient in our clinic; we are constrained by the project protocols. In Thirteen’s case, her intervention seems to be nothing but the drug, and I do not know what outcomes they are measuring since Thirteen has yet to have any choreaform movements. But certainly, she believes she is receiving help, which is what her smile indicated at the end of the scene.
We have seen coercion used in this scenario. Forman is using his knowledge of his new girlfriend to manipulate her, and to do so he is using a second patient to show her how effective the experimental drug is. He has knowingly broken the scheduling log, and was caught by House, who did nothing as yet about it. The nurse should be taken to task as well for breaking the blinding. And these are only some of the issues involved. When we conduct research here at our PCCR, these issues are discussed and resolved long before we ever begin entering patients into our trials. Princeton Plainsboro (House’s hospital) certainly should know better.