Question

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!

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

(a) When patients are enrolled in a trial, it's very important that they are not misleaded that the trial will definitly make them better. When the patient takes the trial as a treatment and not as an experiment, they develop therapeutic misconception. Therapeutic misconception is nothing but the tendency to view medical research such as clinical trial as a treatment to benefit the individual rather than an onvestigation to know more about the drug.

In Josephine's case, she definitely holds a therapeutic misconception. This is quite evident from her response that she wants to give it a shot because she has heard that the initial phases of the trial suggests that the drug has some good effects for people with anxiety and she has also heard of it's effects from some of her classmates. Her keenness to try the drug shows that she is going to take this drug as a way of treating her anxiety and not as a normal research trial. Her statement that even if it didn’t help ward off her panics, Trozole might keep her from developing Alzheimer’s adds weight to our statement.

(b) Clinical equipoise is a condition when the medicine practitioner or the respective expert is not sure about the effectiveness of a particular drug (whether the drug would be 100% beneficial) or he has no good basis of which drug would be more effective when comparing two or more drug.

There is a definite clinical equipoise in relation to the Trozole trials since Dr. Goodhand himself admitted that he wasn’t sure it would be 100% effective. Though he believes that it might help people with anxiety but he also knows that a very little data is available which further puts Dr. Goodhand in dilemma.

(c) In my personal views, it is not ethical for Dr. Goodhand to have Josephine enrolled in the Trozole trial beacuse as a professional medical practitioner, it is their duty to provide high quality health care to their patient and does not put their patient on risk by prescribing a medicine that they themself are not sure about.

But if we see this case from a wider perspective we will find out that Josephine was going through some very serious problem of anxiety and she was not just any other patient but a very educated one who was competent to make her own medical decisions. They had already explored together different treatment options and Josephine herself was very keen to use Trozole since the previous treatment were not able to abid her anxiety and her panics.

Through this point of view, Dr. Goodhand decision to have Josephine enrolled in the Trozole trial does not seems to be unethical.