LC drug trials - we possibly won’t profit too early

[Martin aka paused||M.E.]

This is my personal crystal ball (only what I think):

Companies like Berlin Cures will conduct LC studies on their drugs. If successful, they will sell the patent to Novartis, Pfizer, etc. for a few billion.

The indication for the drug will be Long COVID, so it can only be prescribed off-label for ME.

Big Pharma will, however, make drugs as so-called blockbusters so expensive that we or the majority of us will not be able to afford them - should they actually work for us at all.

Studies on ME / CFS will again not be carried out, as the financial risk is too great for Big Pharma due to the insufficient research situation: They are committed to their shareholders and only geared towards profit and growth.

Critical voices please below:

 

[Alvin2]

Big Pharma will, however, make drugs as so-called blockbusters so expensive that we or the majority of us will not be able to afford them - should they actually work for us at all.

We can make plenty of noise in this case. If ME Action and every other organization is smart they will call as many media contacts as they can google and work the room until the drug companies back down from the mountains of negative PR. And it doubles as raising our profile. A bold move but it could be done.
It comes down to seizing the moment, creating an Overton Window if you will.

Also like vaccines they may be shamed in itself to only charge at cost.

 

[Martin aka paused||M.E.]

We can make plenty of noise in this case. If ME Action and every other organization is smart they will call as many media contacts as they can google and work the room until the drug companies back down from the mountains of negative PR. And it doubles as raising our profile. A bold move but it could be done.
It comes down to seizing the moment, creating an Overton Window if you will.

Also like vaccines they may be shamed in itself to only charge at cost.

What I hope is that we profit from the research in COVID 19. I only meant the drugs developed for it.
But if the media gets interested you might be right.

 

[Alvin2]

What I hope is that we profit from the research in COVID 19. I only meant the drugs developed for it.
But if the media gets interested you might be right.

I meant the drugs, if they try to hose us for it we can beat them into submission. Literally.

In a sense they might not want bad PR, they prefer to hide gouging people behind the shadows because if governments wake up they can legislate away the monopoly laws on new drugs then profits crash. Which is probably why they are selling covid vaccines at cost. No one will support drug companies screwing over untold millions and if its connected to covid they know their goose is cooked.

We can turn any publicity is good publicity on its head in a high profile way if we are bold enough to do it. If it comes to that then its a war i intend to win.

 

[Martin aka paused||M.E.]

I meant the drugs, if they try to hose us for it we can beat them into submission. Literally.

In a sense they might not want bad PR, they prefer to hide gouging people behind the shadows because if governments wake up they can legislate away the monopoly laws on new drugs then profits crash. Which is probably why they are selling covid vaccines at cost. No one will support drug companies screwing over untold millions and if its connected to covid they know their goose is cooked.

We can turn any publicity is good publicity on its head in a high profile way if we are bold enough to do it. If it comes to that then its a war i intend to win.

I hope you’re right!

 

[Alvin2]

I hope you’re right!

Screw hope, have the guns at the ready

 

[hapl808]

Which is probably why they are selling covid vaccines at cost. No one will support drug companies screwing over untold millions and if its connected to covid they know their goose is cooked.

I'm not sure where you are, but as far as I know, no drug company in the USA is selling Covid vaccines at cost? AZ is doing it overseas, but Moderna and Pfizer are profiting hugely. Pfizer refused to accept money from the US government to develop the vaccine because they didn't want the accompanying restrictions. They did agree to sell the doses for $20 (as opposed to AZ $4), but they've said in investor calls that they are excitedly looking forward to post-pandemic pricing when that can go up many times.

I hope you're right, but not sure where your optimism comes from. My optimistic view is that the drugs approved for Long Covid are likely to be only helpful in a small number of people, filled with side effects, and somewhat toxic. So our inability to get easy access will be a blessing.

 

[hapl808]

Studies on ME / CFS will again not be carried out, as the financial risk is too great for Big Pharma due to the insufficient research situation:

Especially lacking biomarkers, any trials on ME/CFS are likely to be inconclusive at best because we don't even have proper inclusion criteria. This is why we're already ignored in other drug trials - we may know anecdotally that ME/CFS people respond to some drug or treatment, but they'll never test it in our population unless they're hoping for a good result (that will drive sales) instead of a bad result (which will add warnings to their product). If the trial is good, it will be heralded, and if it's bad it will be buried and we'll never hear about it.

 

[Alvin2]

I hope you're right, but not sure where your optimism comes from. My optimistic view is that the drugs approved for Long Covid are likely to be only helpful in a small number of people, filled with side effects, and somewhat toxic. So our inability to get easy access will be a blessing.

Not optimism, determination.
If any drug developed helps us, i intend to get it.

Bear in mind that new drug development takes years.

 

[Learner1]

Bear in mind that new drug development takes years

Years is not a time that most of us have to wait. The way the system works in the US, is one has income from a job, which pays bills like health insurance premiums, deductibles, out-of-pocket costs for uncovered care, and if one can't work the job, one loses the health insurance coverage. And if one is persistent, one can end up on Medicare, or destitute enough, one can end up on Medicaid, but the doctors who accept these, the test that can be run, and the treatments can be limited.

Years of this can be devastating for a family and for the patient.

In a sense they might not want bad PR, they prefer to hide gouging people behind the shadows because if governments wake up they can legislate away the monopoly laws on new drugs then profits crash. Which is probably why they are selling covid vaccines at cost. No one will support drug companies screwing over untold millions and if its connected to covid they know their goose is cooked

I know many people who can't get valganciclovir, a useful drug for Epstein-Barr, HHV6, and other herpes viruses, because it's too expensive, running about US$9,000 for a 90-day prescription, for the generics which are priced right under the price of the brand name.

Or Kuvan, which used to be a cheap supplement (BH4) until a drug company patented it and now charge $1500 a month for it. And, and all of the US, it's only available at seven mail order specialty pharmacies, because it's an orphan drug for PKU, even though it's useful for many other conditions and is an essential biochemical in our bodies.

Both of these are useful today in certain groups of ME/CFS patients, but they are not affordable or accessible for most.

 

[Martin aka paused||M.E.]

Years is not a time that most of us have to wait.

yes, yes and yes! That’s why I inhale your posts bc you managed to get much better over the years so it is possible. These are the stories who keep me fighting!!!

 

[Alvin2]

Years of this can be devastating for a family and for the patient.

While true it doesn't change how long drug development takes.

Both of these are useful today in certain groups of ME/CFS patients, but they are not affordable or accessible for most.

This is but the tip of the iceberg, from pharmabro to Epipen to insulin and more, patent protection for drugs is a legalized racket. Not to mention oligopolies and monopolies. The drug companies have many pissed off at them but no government is yet ready to reform or eliminate patent protection. If the drug companies screw hundreds of millions all at once with one drug they will paint a bullseye on themselves and they know it. Hence they want to stay under the radar.

 

[Learner1]

While true it doesn't change how long drug development takes.

Oh, it definitely takes a long time. My point was made, that most of us can't depend on the development of any drug to cure us in a helpful time frame. Much better to use the tools available today, possibly in novel ways, to attack this in a time frame that people sick today can benefit from.

This is but the tip of the iceberg, from pharmabro to Epipen to insulin and more, patent protection for drugs is a legalized racket. The drug companies have many pissed off at them but no government is yet ready to reform or eliminate patent protection. If the drug companies screw hundreds of millions all at once with one drug they will paint a bullseye on themselves and they know it. Hence they want to stay under the radar.

That's exactly what they're doing now, And it hasn't shamed any of them into staying under the radar.

Look at the scandal in the UK over liothryonine, T3, where the government apparently contracted with only one manufacturer, who charged an exorbitant price, many times the cost in any other country including the US, and what did the health system do? Rather than negotiating with competitors for better price, they just stopped testing patients to find out if they needed it, and told doctors not to prescribe it. There's a fix...

The same thing happens in the US, where insurance company formularies decide they don't want to pay for particular drugs, and I think it's happening in other countries where the health system refuses to pay for particular drugs.

 

[Martin aka paused||M.E.]

While true it doesn't change how long drug development takes.

This is but the tip of the iceberg, from pharmabro to Epipen to insulin and more, patent protection for drugs is a legalized racket. Not to mention oligopolies and monopolies. The drug companies have many pissed off at them but no government is yet ready to reform or eliminate patent protection. If the drug companies screw hundreds of millions all at once with one drug they will paint a bullseye on themselves and they know it. Hence they want to stay under the radar.

Martin Shkreli.
No drug company stays “under the radar“

 

[Alvin2]

Martin Shkreli.
No drug company stays “under the radar“

My point is that so far no government is looking to fix this.
Same with climate change it was well known since the 90s, its only now that the will to tackle it is happening.
And even then we are not Marshall Project-ing it yet.

It takes times for things to hit critical mass where the will and motivation to fix the problem means it gets done. Once that tipping point is reached legislation will happen. The drug companies want to keep gouging but not to cause governments to turn on them and change the law and take away their ability to gouge.

Imagine they tried to charge $100,000 a dose for a covid vaccine. No government would say lets just pay it and be glad the drug companies are not charging $200,000 a dose.
They want to stay below the threshold of laws being rewritten to starve them of their golden goose while vacuuming up as much money as they can from their victims.

 

[Learner1]

My point is that so far no government is looking to fix this.

Agreed

 

[hapl808]

Once that tipping point is reached legislation will happen.

This is the entire job of pharma lobbyists and execs. They push as far as they can without tipping over. So the Long Covid people will be told the drug is $5k for them but their insurance will make it $200. The insurance will only pay $300 for it. The patients will thank their lucky stars for their 'great insurance' and the drug companies and pharma companies will reap billions.

The ME/CFS people will likely be told it's not a medically approved treatment for their condition (which so far has been considered separate from Long Covid). Some will have the energy and financial resources to find a willing doctor to rx for them, some won't have the energy to go through that gauntlet.

I likely had something like lyme early on (bullseye rash, etc), but I contracted it while traveling overseas in a region that wasn't known for that. So I was never treated initially despite immediately seeking ID care. I ran out of money at the time so I stopped seeing doctors because I was uninsured.

The US system is a joke for anyone on the fringes. When you see the backlash against people like Bernie Sanders who dare challenge the drug companies directly, you see that there is minimal serious chance of change in our lifetime. The best chance we had for universal government NHS-style healthcare (which has its problems, but not the inhumanity of the US system) was probably Obama. I don't expect to see that again in my lifetime.

Again, like many things, I hope I'm wrong.

 

[Canned]

Maybe I’m too optimistic..

I actually can’t see how we would not profit from LC drug trials. Since it’s already clear, that some Longhaulers develop mecfs, it’s likely that those will be participating in those trials. And if those patients get better from a drug, we get the knowledge that this drug works for mecfs. This alone would be very valuable in my opinion.

The indication for the drug will be Long COVID, so it can only be prescribed off-label for ME.

This might be true. But how are they gonna prove, that you have longcovid? I guess a lot of people do not have an official corona Infektion certificate.

 

[Martin aka paused||M.E.]

Maybe I’m too optimistic..

I actually can’t see how we would not profit from LC drug trials. Since it’s already clear, that some Longhaulers develop mecfs, it’s likely that those will be participating in those trials. And if those patients get better from a drug, we get the knowledge that this drug works for mecfs. This alone would be very valuable in my opinion.



This might be true. But how are they gonna prove, that you have longcovid? I guess a lot of people do not have an official corona Infektion certificate.

True!

 

[Rufous McKinney]

Especially lacking biomarkers, any trials on ME/CFS are likely to be inconclusive at best because we don't even have proper inclusion criteria.

I was just going to say that is our big problem.

"ME CFS" does not exist still as a bracketed entity. Or as 5 subtypes, even.

As long as this continues, we will remain after thoughts. Long haul covid has a discrete- point of arrival (Jan 2020, this thing starts).

ME CFS remains a bunch of rumors, a collection of varied atrocities.