How quickly could an effective drug treatment for ME/CFS be rolled out once approved?

[Sasha]

I don't think so. Even in other countries protests are relatively small as we have to rely on allies and carers, but there is some awareness. I have seen nothing of the sort in the UK.

Protests are relatively small because we're too sick to protest and the protests are basically an endless 'Give us more money for research', rather than 'There's a cure! Bring us back from the dead!' being delivered by now-fit PwME who are back from the dead.

Daratumumab (if it works) can only be prescribed by specialists and they'll tell you they will only prescribe it once an ME/CFS specialist has given the green light. So your GP will send you to your local fatigue clinic run by the BPS brigade

It would make no sense at all to send PwME to a fatigue clinic run by non-clinicians to be screened for getting a heavy-duty drug. I know we're used to Kafka-esque rubbish but the RCT that demonstrates the proof that something like dara works will be a complete game-changer, in a game that is already changing due to DecodeME.

 

[hotblack]

not. I think that's a good scenario to focus on for thinking purposes, though...

Agree. It’s a useful framing for thinking and discussing.

And tbh even if the effectiveness of a treatment was less dramatic if it was backed by evidence it would still be handled similarly. Look at the countless medications prescribed for management of other conditions.

 

[Kitty]

You're right, I've been assuming a 'daratumumab works' scenario in which there are full responders and non-responders, so you are basically 'back from the dead' or not. I think that's a good scenario to focus on for thinking purposes, though...

I don't think it makes much difference, to be honest. If trials show a drug improves the function of people with ME/CFS to a significant degree, it's likely to go into use. Most drugs for chronic conditions improve rather than cure, so a partial effect may not have any impact on the likelihood of approval.

The process won't happen nearly fast enough, but at least people who're locked in darkened rooms will have hope for the future. That's incredibly important.

 

[OrganicChilli]

It would make no sense at all to send PwME to a fatigue clinic run by non-clinicians to be screened for getting a heavy-duty drug.

But that's exactly what's happening at the moment. Each GP or specialist I've spoken to think fatigue clinics are staffed by clinicians. I've had doctors assume they do specific blood tests or the multidisciplinary team includes immunologists or rheumatologists. That belief not going to change overnight.

 

[Sasha]

But that's exactly what's happening at the moment. Each GP or specialist I've spoken to think fatigue clinics are staffed by clinicians. I've had doctors assume they do specific blood tests or the multidisciplinary team includes immunologists or rheumatologists. That belief not going to change overnight.

That's interesting! But it would be easy to disabuse everyone of that notion.

@Jonathan Edwards, should that be in the factsheet for health professionals?

 

[rvallee]

I’d be a lot more concerned about how the treatment would be rolled out in poor developing countries than in the United Kingdom, which is a top 15 country in human development index. How does the treatment get “rolled out” in Sudan and the Central African Republic?

This is an additional concern given that the U.S. just cut a large amount of funding for international health programs.

Ironically, most scenarios probably involve pwME in rich countries having to travel or buy from poor countries if whatever treatment achieves something can be developed but spend years in regulatory approval limbo while saboteurs do everything they can to block it. It all depends on the nature of that treatment, possible adverse reactions, but mostly about what goes on in secret, behind closed doors. Everything about us happens in secret behind closed doors.

Those countries with little regulatory burden might be the only source for a while, something for which no doubt people will be admonished, because however it happens, it will be years until reality is acknowledged to be happening. Rich countries might be the very last to get it approved, especially as the richer they are, the more they did to stifle everything. Poor countries have no such record. They just did nothing, that's not embarrassing when rich countries literally did worse.