Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital

Sasha said:
I trust Drs Fluge and Mella but I'm a bit surprised that anyone can patent a drug for a specific application, including the pharma company that created it. What is the purpose?
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It’s how all drugs are developed. It’s a long process where IP is developed to start with by academic institutions and then bought or licensed by a biotech to continue development and then bought or licensed by a large healthcare company to manufacture and distribute. Patent and IP law protect the investors so someone else cannot copy their product without all the development work so that they will have a return on investment. Patents are often for specific diseases. Drug development wouldn’t happen without it.

I think in this case, it will create revenue for their institution and therefore will fund future work.
 
Jonathan Edwards said:
You would need to re-vaccinate them against lots of things. And we don't have any particular reason to think that the resulting antibodies would be any less harmful than the ones removed by Dara, do we? Your long lived plasma cells are in theory just producing antibodies to things you have been vaccinated against or met as an infection. Why would the new lot be different?
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Isn't this a death sentence?
 
Braganca said:
Drug development wouldn’t happen without it.
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Actually, quite a lot of drug development has occurred without going through any patent process. Most of the drugs used for RA before biologics were, as far as I know, unpatented - if the drug had a patent it had expired long before. Drug development does not need the patent process. People would develop drugs without the process and often have.
 
@Jonathan Edwards, if fixing the issue takes something as catastrophic-sounding as dara, why can't we find treatments that mimic what the bodies of some PwME do when they go into a natural remission? Is it just that we don't know enough to mimic in general what bodies do naturally, or don't know how to manufacture the necessary drugs, or is there some other obstacle?

[Edit: This was meant to be a question about medicine in general, not ME/CFS where we don't know what mechanism to mimic.]

We talked upthread about a temporary but spectacular remission I had from bedbound that followed cold-water therapy. AFAIK, people who go in for cold-water swimming long-term don't end up with impaired immune systems. If my remission was genuinely caused by the cold water, why can't we use drugs to pull the same biological levers in the body?
 
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Jonathan Edwards said:
Actually, quite a lot of drug development has occurred without going through any patent process. Most of the drugs used for RA before biologics were, as far as I know, unpatented - if the drug had a patent it had expired long before. Drug development does not need the patent process. People would develop drugs without the process and often have.
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Really? How did companies protect the product from generics? How did they raise money for development? Do you mean that it still happens today?
 
Sasha said:
Is it just that we don't know enough to mimic in general what bodies do naturally, or don't know how to manufacture the necessary drugs, or is there some other obstacle?

If my remission was genuinely caused by the cold water, why can't we use drugs to pull the same biological levers in the body?
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We don't have a general confirmed mechanism let alone one for spontaneous remissions. How would anyone develop a drug without a target?

My understanding is that dara is a stop gap for some pwME until we have something better.
 
Jaybee00 said:
And people who receive rituximab don’t need re-vaccination because LLPC are still intact?
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That was our presumption. We had no real problems with patients who maintained normal range Ig levels (90%) and probably none with those who had a moderate fall. I think there were some zoster cases but maybe no more than expected. It seems that the main problem was when Covid arrived and patients were unable to mount a new antibody response - but it may just have been their susceptibility due to having RA.
 
OrganicChilli said:
We don't have a general confirmed mechanism let alone one for spontaneous remissions. How would anyone develop a drug without a target?

My understanding is that dara is a stop gap for some pwME until we have something better.
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I know we don't - sorry, your comment has very helpfully made me realise that my question was unclear, so I'll go back and fix it - thanks!
 
Braganca said:
Really? How did companies protect the product from generics? How did they raise money for development? Do you mean that it still happens today?
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Michael Weinblatt suddenly decided around 1982 to treat RA with methotrexate and it became the mainstay for twenty plus years. Methotrexate was already generic and cost a few cents. Sulphasalazine for RA was developed by Brian McConkey in fairly similar circumstances, similar for azathioprine, used by Barbara Ansell. Penicillamine had been made for Wilson's disease by a British neurologist whose name I forget, off his own bat. Jaffé later used it for RA. And so on. I introduced rituximab for RA without a patent and made sure in the courts that the company didn't get a patent either (having made the mistake of not offering me inventor status).
 
Jonathan Edwards said:
Michael Weinblatt suddenly decided around 1982 to treat RA with methotrexate and it became the mainstay for twenty plus years. Methotrexate was already generic and cost a few cents. Sulphasalazine for RA was developed by Brian McConkey in fairly similar circumstances, similar for azathioprine, used by Barbara Ansell. Penicillamine had been made for Wilson's disease by a British neurologist whose name I forget, off his own bat. Jaffé later used it for RA. And so on. I introduced rituximab for RA without a patent and made sure in the courts that the company didn't get a patent either (having made the mistake of not offering me inventor status).
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Interesting, thanks for explaining.

I’m not an expert, but have the experience of being an investor in a small biotech for 7 years. Our company’s ability to get enough financing to get through regulatory approval is dependent on building and protecting IP, and on getting the drug to market before the IP runaway expires. There is still some value even after patent expiry, but much less.

Many of the smaller investors and the CEO invested in the product because their family members are affected by the disease it will help diagnose. It will be a much safer, better, more accessible diagnostic than what currently exists, and will provide more valuable data for researchers. But if there was no IP protection, it would be a compound owned by a university but left on the shelf.
 
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Jonathan Edwards said:
You would need to re-vaccinate them against lots of things.
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I'm working with a beginner's understanding, but I thought we've got memory B cells and long-lived plasma B cells for any particular antigen, and the memory B cells continually create new long-lived cells to replace those that die. So if Dara wiped out the long-lived cells, after some time, the memory cells would replace them.

Jonathan Edwards said:
Actually, quite a lot of drug development has occurred without going through any patent process. Most of the drugs used for RA before biologics were, as far as I know, unpatented - if the drug had a patent it had expired long before. Drug development does not need the patent process. People would develop drugs without the process and often have.
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This is presumably not referring to new drug development by a pharmaceutical company though? Repurposing an existing expired patent drug doesn't require spending millions or billions of dollars on exploratory research and trials. That'd be a lot of money for Janssen to spend, just for any other company to then immediately jump in and compete without having invested anywhere close to that.
 
Braganca said:
But if there was no IP protection, it would be a compound owned by a university but left on the shelf.
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Why so? I spent my life trying to find ways to treat people, without any financial incentive beyond drawing my usual salary. People have used the treatment I developed, off label, for dozens of diseases. Nearly all drugs for RA were lying on the shelf in drug companies until an academic decided to pick them up and try them for RA.
 
forestglip said:
I'm working with a beginner's understanding, but I thought we've got memory B cells and long-lived plasma B cells for any particular antigen, and the memory B cells continually create new long-lived cells to replace those that die. So if Dara wiped out the long-lived cells, after some time, the memory cells would replace them.
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Memory B cells only generate plasma cells if there is antigen around. I agree that you would have a stock of memory B cells for each virus but expanding an antibody response to antigen X by making new plasma cells from memory cells, in the absence of any priming antibody to X from old LL plasma cells would probably take several days - maybe a couple of weeks. Dangerous infections kill you before then. Thre aren't that many really dangerous infections around endemically of course but if you have a blunted immune system because of some other illness like RA or lupus you would be at significant risk.
 
forestglip said:
This is presumably not referring to new drug development by a pharmaceutical company though? Repurposing an existing expired patent drug doesn't require spending millions or billions of dollars on exploratory research and trials.
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We were talking in the context of repurposing daratumumab, and I was raising various other repurposed drugs, yes.

But developing a new drug does not necessarily require a big pharmaceutical company. As has been said, a lot of these drugs were developed in academia and sold to biotech compnies, that then got swallowed up by big pharma companies. Rituximab I am fairly sure came from an academic group. Another anti-B cell drug was developed early on by the Stevenson's in Southampton - in university labs. They even went into production I think, but it turned out to be less potent.

Mostly big pharma companies are just ways of milking the system for big bucks. I used to visit the big pharma groups in my field regularly - in the UK, Switzerland and USA especially. The waste of money on dead end projects was mind-blowing. We would have far more drugs far more readily avaiable at a much lower price if we had no big pharma or patents in my view. Public ownership of IP has never been shown to inhibit good medicine.
 
As an economist, I don’t buy the argument that developments will not be made without patents. That is a narrative created by people that claim that all people are perfectly rational and only seek to maximise their own value. In economics, this assumption is called homo economicus.

This assumption results in the narrative that nobody can expect anyone to do anything for them, unless they provide something equally valuable in return (I won’t develop drugs for you unless you make be even more wealthy through healthcare payments, taxes, etc.).

That is not the only valid reason to expect someone to help others.

PS. I don’t intend to get into the politics side of this.
 
I think the main question is if the really expensive drugs will still get made. Pharma companies have to spend billions, not only on the drugs that eventually make a profit, but on plenty that never make a dime. If they have to sell these billion dollar drugs at market prices that might not allow them to even recoup their investment, why would they waste time on researching those novel drugs?

Maybe through some mechanism, government could run the whole operation as a public service. But as it stands currently, I'm guessing there just wouldn't be money or incentive to spend billions gambling on new drugs without patents.
 
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