Question

Case Study:

Josephine has been experiencing anxiety for years. She is currently finishing the third year of an intensive health sciences degree program. Josephine was referred to a mental health specialist, Dr. Goodhand, when she first moved away to university. Dr. Goodhand’s office is just off campus and is very convenient.

When she first met Dr. Goodhand, Josephine told him about what she calls her panics which she describes as overwhelming feelings of panic and dread that make her heart race, her brow sweat, and leave her feeling exhausted.

Her medical records confirm that Josephine has taken a variety of medications to combat her anxiety over the last several years. She was originally prescribed Xanex and found this worked well in the short term, but caused her to feel sleepy and caused her stomach to twist in unpleasant ways. Josephine indicated that she knows about other medications like Xanax, but she has done her homework and knows that these are likely to have the same side-effects and that all of these drugs are addictive. Of course, she worries about becoming addicted and joked with Dr. Goodhand that this might just be her anxiety worrying.

Josephine told Dr. Goodhand that she avoids recreational drugs and alcohol entirely—though she also confessed to finding pot helped calm her down a few times. (She swears she only tried this after it was decriminalized!)

Dr. Goodhand initially prescribed a different kind of medication called Zoloft, an anti-depressant medication that is known to be effective in helping some people with anxiety. Because Zoloft doesn’t kick in right away when it is taken, Josephine had to take this drug on an ongoing basis. After nearly a year, she decided to stop taking this drug because she wanted to avoid relying on medications all of the time and she found that that this drug was also affecting her stomach—was there anything that didn’t send her running for a bathroom? What’s more, she worried that this drug was making her feel drowsy though she acknowledged that this could be a result of her busy schedule, or the fact that she knows this is a common side-effect of the drug. She found that, over time, and despite playing with different prescribed dosages, her anxiety and her panics weren’t abiding.

Since she stopped using Zoloft last year, she has been trying to manage her anxiety by getting lots of exercise and by utilizing stress-management techniques she had been taught by a counsellor when she was in highschool. Though she has reported that she is generally doing fine, Josephine thinks that her schoolwork is suffering as a result of her anxiety. (Dr. Goodhand has noted that her major, grade-based scholarships have just been renewed for the final year of her program.)

Dr. Goodhand believes Josephine is competent to make her own medical decisions—indeed, he is impressed by her understanding of each of the treatment options they explore together.

Dr. Goodhand is keen to recommend that Josephine try another drug he wants to prescribe for her. This one—a kind of beta-blocker—is known to have fewer side effects than the other drugs Josephine had tried, though Dr. Goodhand admitted he wasn’t sure it would be 100% effective. Dr. Goodhand hasn’t yet had a chance to recommend this option as Josephine has cancelled her last two appointments.  

Josephine arrives to Dr. Goodhand’s office today and it is clear she is having a hard go of it. She says the panics are back and she reports that she has been feeling constantly restless and uptight; she hasn’t been to any of her classes for the last four days.

Josephine tells Dr. Goodhand that the only reason she came to her appointment today was to get herself enrolled in the trial for a new drug. Josephine is keen to try this new drug. She had heard someone talking about what its done for them in one of her classes and she wants to be enrolled in the trial. As usual, Josephine had done her homework and knows that this new drug, Trozole, is being tested to treat anxiety as well as a host of other conditions ranging from Obsessive Compulsive Disorder to Alzheimer’s disease. It seems to have few side effects and the initial phases of the trial suggest the drug has some good effects for people with anxiety. Dr. Goodhand is not so sure. He has read about Trozole and, though he believes that it might help people with anxiety, he knows that very little data is available. Further, he knows that the ongoing clinical trials utilize a placebo control, meaning that half of the patients enrolled in the study will receive no treatment. And, when pressed, Josephine admitted that she had read that no data is available concerning the effects of withdrawing from this drug. Nevertheless, Josephine wants to give it a shot. She then joked that, even if it didn’t help ward off her panics, Trozole might keep her from developing Alzheimer’s!

The Assignment: Draw on the relevant readings to complete the tasks identified in one of the following options.

Option 1: This option has three parts. (a) Explain what is known as the “therapeutic misconception”. Then, state whether you think Josephine holds this misconception and defend your statement. (b) Explain “clinical equipoise”. Then, state whether you think there is clinical equipoise in relation to the Trozole trials and defend your statement. (c) State whether you think it is ethical for Dr. Goodhand to have Josephine enrolled in the Trozole trial and defend your view.

Answer 1

In research or in any clinical procedure it is expected from researcher or from clinician that honest and complete information would be provided to the participants about the objectives, procedures, possible risk, side effects and other details and consent would also be taken in written. Several cases are witnessed where person holds the impression that he is undergoing the treatment for his problems and he is able to distinguish between treatment and clinical research. When all the details about the purpose or procedure are not given to the person who is at the receiving end, he would not able to distinguish between the clinical trial and ordinary treatment and this is called therapeutic misconception. It is the the tendency when person perceives research as treatment. In this given case, though Josephine is aware about the side effects but Dr. Goodhand has not explained the complete procedure to her and has not disclosed it clinical research to assure the benefits of drugs.

Clinical equipoise exists when a doctor or the person who is prescribing the treatment is not sure about the possible benefits or the possible side effects and he offers such treatment to patients. This is also called uncertainly principle. It generally takes place in clinical trial research. In the given case study there is clinical equipoise in case of Trozole trials because even Dr. Goodhand is sure how effective this drug is going to be and how is it going to harm the patient.

It is not ethical for Dr. Goodhand to have Josephine enrolled in the Trozole trial because when we talk about research ethics, it is assured that patients should be informed about the objective of the research, procedures, possible risk etc. There are five principles of research ethics and Dr. Goodhand is disobeying the most of the principles. The first is to minimize the risk of harm. In the given case Dr. has idea about the possible risk but he has not taken any steps towards minimizing the side effects. According to second principle, subject’s informed consent should be taken but Dr. has not even informed that is not a treatment but she is a part of clinical research. Doctor is also conducting the deceptive practice by hiding the objective of the research.