USA Minnesota - Dr Tam

Not everyone can take 0.5mg of Abilify to see if it works. My doctor would laugh at me if I asked. Even those who can find some online may not be willing to do so without a doctor monitoring them.

I've said upthread that I understand why doctors do prescribe poorly unevidenced treatments. But, I stand by my statement that doctors who do so are part of the problem of the lack of clarity around what, if any, drugs help. No, it doesn't take 10 years for someone to do a small double blinded trial. I'm sure one of the patient charities could help fund one, it could even be partly crowdfunded. In fact, I expect if a doctor went to a patient charity, the patient charity could find people to do most of the work of setting up a trial. The thing is, if the doctor's aim is really to help people, then a trial is the best way to do that. Because once there is some solid evidence that a drug works, more studies will flow, the drug can be included in clinical protocols around the world. The drug can be included in treatment schedules and funded by governments. Huge numbers of patients can benefit, rather than a select few. Work can be done to find out which patients benefit and which ones don't, so people who don't don't have to waste time and side effects trying it. And, we have a reliable piece of data, a clue into what is causing ME/CFS, or a subset of it, or what the downstream impacts are.

I think that patients who are convinced that a drug they are taking is helping ME/CFS should be asking their doctor to run a trial. I think that is the ethical thing to do. In my view, doctors who are benefiting from people flocking to their door wanting a particular drug treatment have an ethical responsibility to run a trial.

Maybe this Dr Tam, who by all accounts is a caring doctor, would be a good person for a patient charity to partner with, to run an Abilify trial? I'd be happy to help write a protocol.

 

I would have thought that a trial that is run as part of an existing clinical practice wouldn't have to cost nearly so much. If Dr Tam or someone prescribes Abilify to 75 patients a year, maybe she can get 50 patients to agree to be part of the trial. 25 in each arm - placebo and active. The clinic is keeping records anyway, they talk the patients through the side effects anyway, they monitor the patients over the following year anyway. So, that's all largely covered by consultation fees. An honorarium for the doctor and for someone to manage the randomisation and preparation of the pills. Honoraria for the patients. The drug company might donate the Abilify. Something for the statistician, we might even find someone willing to do that at no cost if you involved a student and their professor - they might be able to access other funds.

Insurance in the US might be a big cost. I don't know how much that would be. Maybe people here who know can tell us what other costs there are? Maybe some admin costs - registration, ethical approval costs, publication costs?

If the study is well blinded, subjective outcomes might be enough. If you wanted to monitor activity levels, there would be a cost for wearables.

I can't see that all getting to $10 million. But obviously, I don't know.