USA Minnesota - Dr Tam

It’s goes without saying that I’m all for Dr Tam giving patients the option to try Abilify, they will be helping a number of people because I’m sure already in their practice there were some pwME who were at least temporary responders, and that is a good thing to me. Abilify makes my PEM go away for a while, and that’s the hallmark symptom of ME/CFS. No other class of drug I’ve tried has ever done that, not Wellbutrin, not SSRIs/SNRIs, not LDN, not anything else psychotropic or otherwise.
 
Hutan said:
I do think that any treatment that a doctor offers should either be backed by good quality trial evidence or the treatment should be offered as part of a trial. I think a doctor who, after treating the first few patients, doesn't do that is part of the problem of the lack of clarity around what works and what doesn't.
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Jaybee00 said:
Yes, waiting 10 years for someone to raise 10 million USD, conduct a trial and publish results seems like a strange hill to die on when you could take 0.5 mg of Abilify for 15 days to see if it works.
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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.
 
Jaybee00 said:
Ron Davis estimated it would cost $10 million to do an Abilify RCT trial. This paper from 2018 says the mean cost of a phase 3 trial is about $19 million.
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But you wouldn't begin with a phase 3 trial, surely? Groups usually start with phase 1 or 2 trials, with smallish cohorts. If the results looked strong enough, they'd use them to justify a phase 3—and at that point it should be possible to apply to major funding programmes.

It might be that phase 2 trials would need to be completed in a couple of different centres before a funding application would have a good chance of success, but that's often the case. The initial studies need to be well designed, but they don't need to be especially big.
 
Phase II still expensive—from wiki:

https://en.m.wikipedia.org/wiki/Phases_of_clinical_research

The amount of money spent on Phase II or III trials depends on numerous factors, with therapeutic area being studied and types of clinical procedures as key drivers.[29] Phase II studies may cost as low as $7 million for cardiovascular projects, and as much as $20 million for hematologytrials.[29]

Phase III trials for dermatology may cost as low as $11 million, whereas a pain or anesthesia Phase III trial may cost as much as $53 million.[29] An analysis of Phase III pivotal trials leading to 59 drug approvalsby the US Food and Drug Administrationover 2015–16 showed that the median cost was $19 million, but some trials involving thousands of subjects may cost 100 times more.[30]
 
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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.
 
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