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Re: Question about 'Public Domain' results?

Also, for a new drug to get to market, you have to spend literally hundreds of millions of dollars on clinical trials - and not every drug tested in this way makes it to market.

There's also nothing to stop a competitor from jumping in an offering a generic version once the drug is FDA approved because the drug itself is public domain.


That's a reason for companies not using public domain information, full stop. If you really believe the above is a fair representation of how WCG information is going to be used then WCG is dead in the water.

It's irrelevant, and a complete red-herring, as to the question of whether if such information is used, that it should be acknowledged.

What will most likely happen is whatever drug we find will be used as the basis for an effort to find a molecule similar to the our drug but with better activity for whatever its target happens to be.

So it would be as if we discovered codeine and the pharma company took our molecule and developed morphine. They are both opiates, but morphine is much stronger for pain relief.

Since it's a different molecule, they will be able to get full patent protection.


Exactly. It's -very- unlikely that any drug developed upon information from WCG will get to the market without some protection, even though the WCG information may be provided at no cost and made available to all.

It is, as you point out, not commercially viable for one company to spend millions on all the clinical trials, to have a generic manfacturer grab it as soon as it gets the relevant approval in the relevant country.

Therefore someone is only going to progress the results if there is something commerically in it for them, i.e. a (patent) protected profit.

So realistically, WCG results are only going to be used where the user believes that they have scope for building patent protectable develpments from those results.

So I don't see why access to WCG results shouldn't be made conditional upon entering an agreement whereby anything commericalised that built upon those results, shouldn't at least acknowledge the contribution.

It doesn't cost the user anything, so it's not going to put off any charitable/not-for-profit organisation what wants to access and build upon the results. I think any such organisation would be more than happy to acknowledge the contribution.

First, no one but the pharmacist would see it.


Utter nonsense. When you get your prescription you get given it with all the packaging and safety information. Maybe not in the states (I don't know) but the other side of the pond, there is a requirement that detailled information on manufacturer, safety information, dose information, side effects, etc, be provided with all drugs. I don't think it's unreasonable to put in the bottom corner of such a booklet a WCG logo and web address in small print.

If a drug is going to be effective against Dengue it's going to need to be available en-masse. Which means likely self medication. Like anti-malarials. The end user will see the packaging.

And contrary to how it is this side of the pond where drug adverts are pretty much banned, on the US side of the pond they are everywhere. I don't see why a small WCG logo at the bottom of any advert for a drug developed from WCG information shouldn't be a requirement of any access to WCG results.
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Sekerob
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Re: Question about 'Public Domain' results?

How ever this is spun, there is core science data collected that can be used by anyone and upon which new science can be build. Help Defeat Cancer is such an example which will work to provide a world wide accessible database to further speed the diagnostics and link type to best treatment available. If at the end someone makes money out of this I really do not care, if only one eureka comes from Scripps or UTMB or Harvard or John Hopkins or the Sorbonne I'm happy.

WCG facilitates speeding science along years ahead of where it otherwise would be and that's why we've arrived here and if that's considered a naive notion on my / many's part, that's fine. Credit given, great. If made conditional to appear on the end product beyond the original research data, doubt this grid would have come off the ground.
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[Feb 4, 2009 11:16:02 AM]   Link   Report threatening or abusive post: please login first  Go to top 
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Re: Question about 'Public Domain' results?

If you really believe the above is a fair representation of how WCG information is going to be used then WCG is dead in the water.

Either provide external references to support this claim or confirm that this is your own personal ***** opinion. What is your point in making this claim?
It is, as you point out, not commercially viable for one company to spend millions on all the clinical trials, to have a generic manufacturer grab it as soon as it gets the relevant approval in the relevant country.

This confirms that it may be that a generic manufacturer will bring a drug to market. Can you provide a financial analysis regarding the costs to develop a new drug and why WCG research will prevent a company from producing a new drug?
So realistically, WCG results are only going to be used where the user believes that they have scope for building patent protectable develpments from those results.

An alternative concept is that someone will build a drug when they do not have to expend millions in research.
So I don't see why access to WCG results shouldn't be made conditional upon entering an agreement whereby anything commericalised that built upon those results, shouldn't at least acknowledge the contribution.

But then the WCG results would not be in the public domain and WCG will have to expend non-existent resources to enforce the acknowledgement. For the cost of one lawyer, I can hire an infinite number of volunteer crunchers.
I don't think it's unreasonable to put in the bottom corner of such a booklet a WCG logo and web address in small print.

I personally believe it is unreasonable. Who is going to set the standards for the logo, maintain the address to be used and enforce this? WCG is in the business of crunching, not legal enforcement.
The end user will see the packaging.

And you think the user a) will read it b) have any idea of what WCG is c) care even the least about WCG when they are possibly going to die from Dengue fever?

Finally, we are crunchers and our opinions on how WCG chooses to operate is something that is truly irrelevant. We all knew the terms and conditions when we decided to contribute.

**Edited for intolerance**tkh
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[Edit 1 times, last edit by TKH at Feb 5, 2009 1:46:36 PM]
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Re: Question about 'Public Domain' results?

I'm an indian...not a chief.

I just crunch away...well...crunch away as much as my little P4 HT will allow.
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Re: Question about 'Public Domain' results?

What is your point in making this claim?


**read the post I was replying to.

***


You mention in your post the WCG T&Cs. Nothing I said was in contravention of those T&Cs *****
Can you provide a financial analysis regarding the costs to develop a new drug and why WCG research will prevent a company from producing a new drug?


Cost to bring a drug to market, several million in up-front expenses setting up clinical trials. If the drug can then immediately be copied by a generic manufacturer (the claim that was being made in the post to which I was responding (to answer your question above)) then there would be no commerical incentive to fund those trials.

No business in their right mind is going to fund trials if they feel that as soon as they are succesful a competitor can bring out a generic version with no R&D costs to claw back.

*********

An alternative concept is that someone will build a drug when they do not have to expend millions in research.


If you think that the results from WCG will be a drug ready and waiting to be commercialised, you really, really, really, really,really, really, really, don't understand the process. There are whole stages inbetween (at minimum efficacy trials, and safety trials) requiring additional significant financial investment before there will be a commercially viable (i.e. approved) drug. WCG cannot do those trials out on the grid. Someone has to pay for them with real upfront money.

If as soon as you've paid that money and done the trials, drugs'r'us down the road then immediately sell the drug in competition at rock bottom margins (like generic manufacturers do) and take all the sales (and hence profits), why the heck should I put up the money if I'm not going to be able get it back because of generic competition!

Finally, we are crunchers and our opinions on how WCG chooses to operate is something that is truly irrelevant.


Of course. WCG doesn't give a stuff about my opinion. My opinion is irrelevant. OK.... where's that icon... Right click-> exit.

Oh, apparently ... 'This will shut down World Community Grid and it's tasks entirely...'... well, yep, that's pretty much why I just selected it... clicks OK. Woohoo. Task manager now showing nice dark green and one less icon in the system tray. And less electricity usage as well. Maybe I should have done this sooner.

We all knew the terms and conditions when we decided to contribute.


Absolutely. And none of those terms oblige me to keep contributing if I feel my (genuinely held, and sincerely expressed) opinions are not welcome.

Worried that asking a drug company to print a tiny logo on their product might put them off the potential millions of profit they would otherwise have made? Cor blimey, what planet are you on. Put small logo on product or pass up chance to make several million profits? Hmmm, difficult one that.

Worried that you might be putting off volunteers by telling them their opinion is worthless? Seemingly not!
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[Edit 1 times, last edit by TKH at Feb 5, 2009 1:49:55 PM]
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Re: Question about 'Public Domain' results?

Hi, tresjolie.

Relax, astrolab and twilyth don't represent World Community Grid. They are just members expressing their own opinions (exactly like you can).

As for the specifics of those opinions - I think both opposing views are too polarised. Public domain research won't make is impossibly easy to create a generic drug, nor will it put off pharmaceutical companies from using the research.

What it will do (hopefully) is make it easier to create a generic drug, limiting the scope of any patents held by the pharmaceutical company.
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twilyth
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Re: Question about 'Public Domain' results?

What it will do (hopefully) is make it easier to create a generic drug, limiting the scope of any patents held by the pharmaceutical company.


Personally, I would like to see that happen, but even if you think a drug can be pushed through for FDA acceptance under something like the orphan drug criteria, you're still talking about some serious expenditure aren't you? I don't know, but I would hope that even orphan drugs have to be shown to be safe if not effective.

However, there is always the option of letting it get approved overseas where approval criteria may be more lax or non-existent. But then you have the moral dilemma of permitting what amounts to human trials on 3rd world "volunteers".

So if you can show me how a generic drug could be brought to market cheaply, I would be interested in seeing that.

But as to the original issue, you can make an argument for both approaches. The bottom line is that it is a judgment call. If you want to go on and on about how it was the wrong judgment, that's fine, but it's not going to change anything. Even if you make it a criteria for future projects, the fact of the matter is that many people have already signed up with WCG on the basis of certain representations - one of them being that WCG would have no interest in any data produced. There's no easy way around that one.
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Re: Question about 'Public Domain' results?

I think you may be confusing the orphan drug criteria (which I had never heard of before - interesting subject) with an Abbreviated New Drug Application (compared to a New Drug Application). That's in the US, anyway.

The manufacturer simply has to prove bioequivalence, instead of the hugely costly process of testing a completely new chemical.

But the orphan drug stuff is fascinating reading. It probably applies to a few of the rarer Flaviviridae, but most of the DDDT targets are very common.
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twilyth
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Re: Question about 'Public Domain' results?

I think I know what you're talking about. But we're probably using the term 'generic' in a way that might be technically accurate, but misleading. In the US, it almost always means a patent drug that is now off patent. I assume that bioequivalence would apply if there were a drug to compare it to. I don't know. It might be broader than that.
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Sekerob
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Re: Question about 'Public Domain' results?

This hooks into the "lowering cost" and "open access", and it comes of all from a big pharma:
Harnessing the Crowd to Make Better Drugs: Merck’s Friend Nails Down $5M to Propel New Open Source Era

Biology has never really had a social-networking movement like open-source computing, where thousands of loosely-affiliated people around the world pool brainpower to make better software. If Merck’s Stephen Friend gets his way, about five years from now, he will have ushered in a new era in which biologists work together to make drugs that are better than any company can today inside its walls.

Friend, 54, is leaving his high-profile job as Merck’s senior vice president of cancer research, after having nailed down $5 million in anonymous donations to pursue this vision at a nonprofit organization getting started in Seattle called Sage, Xconomy has learned. I heard about this potentially transformative idea during a phone conversation a couple days ago with Friend and his co-founder from Merck, Eric Schadt.

Sage is built on the premise that vast networks of genes get perturbed, or thrown off-kilter, in complex diseases like cancer, diabetes, and obesity. Scientists can’t just pick one faulty gene or protein and make a magic bullet to shut it down. But what if researchers around the world capturing genomic profiles on patients could get all of their data to talk to each other through a free, open database? A researcher in Seattle looking at how all 35,000 genes in breast cancer patients are dialed on or off at a certain stage of illness might be able to make critical comparisons by stacking results up against a deeper and broader data pool that integrates clinical, genetic, and other molecular data from peers in, say, San Francisco, New Haven, CT, or anywhere else.

read on: http://www.xconomy.com/seattle/2009/03/02/har...ogy-into-open-source-era/

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