COVID Moonshot - should it be left without saving lives?

[JimF]

You are confusing a few issues. But the main point is that if a drug is "patent free", it won't earn enough to justify the research and development necessary to create it. The funding (from venture capitalists for example) won't be available unless the investors can get a good return on their very risky investment. But if a company such as Pfizer wants to thereafter grant a low-cost or free license in some low-income countries, that is the way the system usually works. (Drug prices are a lot higher in the U.S. than in most countries, even than in Europe. The U.S. consumer pays for the R&D.)

If you want to hope that the charities can provide sufficient funding instead, that is up to you. But a charity would have to ask why fund an item that the consumer could pay for, when they could use their limited resources elsewhere? In the case of COVID vaccines, for example, it would probably be cheaper for a charity just to pay for a low-cost license to one of the already-developed vaccines than to develop a new one just to avoid patents, which seems to be your goal. In fact, such a "completely patent free" project would lose the benefit of the money already spent by the pharmaceutical companies. The main costs by the way are not coming up with the formula that works in the lab, but the subsequent testing, both on animals and especially humans. That costs many millions of dollars, often hundreds of millions. Just saving some money on the initial research in order to avoid patents would not count for much.

But if you can show an example where a drug was actually developed and put into use according to your model, that would help your argument.

[JimF]

By the way, I am all in favor of supporting Folding on COVID, or anything else. But that is because it is different technology than anyone else can do. FAH might be able to find useful molecules that no one else can. But they still have to figure out how to get them through testing and into production, which could involve considerable capital expense on new production techniques by itself.

I have been concerned about that problem for some time, and have posted on it before. At some point, they will need to figure out how to partner with a real money-making enterprise to carry it further. Knocking out patents does not help that process, but maybe they can figure out something else.

[gunnarre]

DNDI has already funded two new compounds (in partnership with governments and drug companies), as well as gotten ten treatments approved based on known compounds or new combinations of compounds: Treatments delivered

Since 2003, DNDi has worked with its worldwide network of partners to:

• develop two new chemical entities: fexinidazole, the first all-oral treatment for sleeping sickness, and ravidasvir, a simple-to-use and affordable treatment for hepatitis C
• develop 10 new treatments from existing molecules and recombining drugs to bring better treatments to patients for malaria, Chagas disease, leishmaniasis, HIV-visceral leishmaniasis co-infection, and paediatric HIV
• initiate GARDP, a not-for-profit research and development organization developing and delivering new or improved antibiotic treatments

While the traditional drug discovery and approval process is usually based on secrecy and patents in the initial phases, open data about a disease can help jump-start even traditional drug companies to make and get approved new drugs.

But a charity would have to ask why fund an item that the consumer could pay for, when they could use their limited resources elsewhere?

If the purpose of the charity is to make drugs for common diseases more affordable, because they see that as a public good, then they can do it. Also it's not a given that all drugs would be paid for by the consumer, for example if a generic drug could be used to treat a disease that is prevalent in developing countries, then the lack of patentability might discourage a traditional venture funded company from moving through the approval process; since any competitor could market the drug, they can't recoup their investment in clinical trials and approval. Charities/non-profits and governments can pick up the slack there and fund the trials and approvals, thus unlocking the new treatment to be delivered by several potential manufacturers.

[JimF]

That is very nice, but at least in the case of COVID Moonshot (I did not check the others), they are reliant on funding from the United States NIH.
https://dndi.org/research-development/p ... -moonshot/

I don't think that charities as such are carrying the freight there, and probably can't due to the large expense of the clinical trial. A lot of drugs in the U.S. benefit from NIH funding at some point. They seem to have made an exception for COVID and provided more. That is nice, but not necessarily repeatable.

No, the "open data" does not jump-start drug development. As I have noted above, the only anti-virals for COVID thus far are the privately-developed ones. That is because they have an incentive to do so. The open ones may follow along later, assuming they can arrange the grants and contributions.

The lack of patentability means that manufacturers may not recoup their investment in new manufacturing techniques. So the the generic manufacturers will probably have to stick with whatever they have in place (that is why they are generic). That may not work for very innovative drugs (mRNA being an obvious example). If charities want to fund the generics to obtain low-cost drugs, that is fine, but they may not get to market very quickly.

It is not clear that COVID Moonshot, in spite of its innovative technology, will succeed. We hope so, but it is just one effort among many. It may not even be the most cost-effective. (Just because they don't have patents says nothing about that.) We don't know what the manufacturing costs will be yet, or its effectiveness.

I am still not quite sure what state it is in, but at least it seems they are still working on it and have not reached a dead end yet. That is good to know.

[gunnarre]

No, the "open data" does not jump-start drug development.

The reason why we could get mRNA vaccines developed so quickly is because the genetic sequence of the virus was quickly discovered and published so that the pharmaceutical companies could start generating vaccine candidates.
The Covid Moonshot was not involved in the development of the currently approved oral anti-virals, since those were based on either existing anti-viral drugs, or in the case of nirmatrelvir it was synthesized based on compounds that Pfizer had made in the SARS epidemic back in 2003. Remarkable work for sure.

[JimF]

Just looking at the anti-virals, which is what COVID Moonshot is doing, shows the advantage of the free-market system, if you are willing to pay for it.
If you aren't, you can wait for the publicly-funded ones. It is like public housing verses private. They each may serve a purpose, but you should understand the difference.

By the way, the reason we could get the mRNA vaccines developed so quickly was that the technology had already been developed at the University of Pennsylvania. The first application was for the Zika virus, but it was not needed. So they were ready to go for COVID19.
https://www.pennmedicine.org/mrna
The sequencing can be done by a lot of labs around the world. It is a necessary, but not unique, contribution, and takes only a few days in any case. The development of the mRNA technology took years, if not decades.

A more complete history of mRNA is given here, but you need a subscription (there is a free trial though).
https://www.washingtonpost.com/science/ ... a-vaccine/

[Joe_H]

The first application was for the Zika virus, but it was not needed. So they were ready to go for COVID19.

That would be the first for humans, mRNA vaccines had been released for veterinary purposes a few years earlier. As for the one for Zika virus, "it was not needed" is not quite what I have read elsewhere. Other reports were that there were a number of issues with the vaccine, Moderna stopped further testing

[JimF]

The Zika vaccine was successful in protecting monkeys, but it went back on the shelf as the threat receded. It turned out to be a dry run.

That is how the Washington Post put it.
But that is irrelevant to my point anyway. They had developed the mRNA technology by the time COVID19 came along.