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Mari333 Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 09:59 AM
Original message
Cancer Cured in Canada, But Big Pharma Says NO WAY!
 
Run time: 03:20
https://www.youtube.com/watch?v=OpRkIW5u3bM
 
Posted on YouTube: September 19, 2009
By YouTube Member:
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Posted on DU: January 06, 2010
By DU Member: Mari333
Views on DU: 1932
 
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still_one Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 10:09 AM
Response to Original message
1. That is a bit of a distortion. So if a large pharmaceutical company doesn't do it, there are a lot
of other companies who can and would.

Also, I would like to know which pharmaceutical companies specifically said they would not utilize it. The newscast was far from clear. Was it from an analyst or was it specific pharmacetical companies?



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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 12:22 PM
Response to Reply #1
9. no, because they would not have an exclusive on it
This drug is not patentable. There is therefore NO FINANCIAL INCENTIVE for anyone to take it through the approval process.
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Junkdrawer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 12:25 PM
Response to Reply #9
10. Exactly Correct. And at the end of the piece, the reporter mentioned...
that she's seen this "dropped because it's a new use of an orphan drug" phenomena happen over and over again.
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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:01 PM
Response to Reply #10
13. look up "low dose naltrexone"
And you'll find a cancer treatment in the same category, that has enormous potential. Fortunately a few studies have been done in humans.

This cost is about thirty bucks a month or so.
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Guilded Lilly Donating Member (960 posts) Send PM | Profile | Ignore Wed Jan-06-10 10:17 AM
Response to Original message
2. If it were more profitable to cure cancer
than treat it, it would be cured.
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Karenina Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 10:19 AM
Response to Reply #2
3. BINGO!
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Fire1 Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 10:34 AM
Response to Reply #2
5. Nail on the head. n/t
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ProfessorPlum Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 11:24 AM
Response to Reply #2
6. I think a lot of people would be happy to do either
finding cures or treatments for cancer is a tough, tough game.
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TheWraith Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 12:19 PM
Response to Reply #2
8. It would be.
Unfortunately, this "cancer cure" is based on one study which has not been peer reviewed and a shitload of internet snake oil.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 12:50 PM
Response to Reply #2
11. Cancer is not a disease
it is thousands of diseases each affecting different cell types in different ways and responding differently to stimuli. The idea of a magic bullet to cure cancer is a myth that can not be reached due to the simple fact that there are so many different ways to contract and react to cancer.

Some, many more than a few years ago, cancers are for all intents and purposes curable. Not many people die from skin cancers other than melanoma or some rare forms. Many childhood leukemias are routinely cured. Calling a cancer cured is a risky business from a medical standpoint because it can come back even several years later. In addition the chemo and radiation therapy, though better than it was even a few years ago can still be the base for a new cancer.

Working in the pharma industry I've encountered people who really believe that in the basement we hold the cure to cancer and keep it from them just to sell chemo drugs. I wish, I know a few people that would still be here if we had that hiding out.
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Junkdrawer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:00 PM
Response to Reply #11
12. The issue this video exposes is NOT that Big Pharma is hiding cancer cures....
but rather that there is no financial incentive to go through the expensive process of approval for a nonpatentable drug.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:37 PM
Response to Reply #12
16. That is where the Government needs to be involved
In the US the NIH should be funding it, in Canada the MRC or some other public agency. The lowball estimate ($100,000,000) of the reporter to get a drug to market might be right if they can use the previous pre-clinical testing protocols for it when it was first developed. The Government could argue that there is the potential to cheaply treat cancer and make the sale for the testing but they would be on the hook for the immense risk of failure as well.

I'm not familiar with this drug but the testing agencies are very very conservative now and likely would insist on a full clinical protocol at least if not the full or, if very lucky, a partial pre-clinical set of trials bringing the cost of development up to well over the hundred million mark.

Keep in mind too that it is a truly untested drug for cancer, this is a single result in rats with humanized immortal cell lines, a nice model but it's still not a human and it's not a sure thing and taking this drug to the clinic for a single cancer would still carry huge risk of failure. The testing protocols accepted even 10 or 15 years ago are not allowable anymore for FDA submission because of lack of cardiac testing that must now be done for every IND application along with a host of other tests and studies.

Based on a single study calling it a potential cancer cure is really overblown. I've seen many "potential cancer cures" in the basic science lab go nowhere, not because of funding but because the mechanism falls apart on further testing.

Keep in mind that the approval process in place now is there because of demands for greater safety testing, it's not even remotely cheap to take a drug through the process and no company is going to fund it without at least a shot at getting some of the money back.
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Junkdrawer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:48 PM
Response to Reply #16
18. Would Big Pharma agree to "socialize" the drug approval process.....
if it also meant that the profits on successful drugs were severely capped?

Or do you think that they would fight to keep the current costly-yet-profitable model in place?
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 02:12 PM
Response to Reply #18
20. That's actually a more complicated
question than I think you meant to ask.

The first answer is probably not unless the current market system is changed to one in which investors would be happy with an income based approach. I blame a lot of the financial issues from big pharma directly on the investors and the CEO's that insist on a growth based investment. When you don't see a yearly 10% gain in the stock price investors run, the companies merge and merge and pretty soon all of our drugs are being developed by Pfizer. If you want to see an inefficient monstrosity of a corporation just take a look at that one.

If the business side of the industry could move to a more easily managed income model where overall performance isn't based on yearly growth but simple profit a more socialized approval process would be more acceptable as long as the risk was equally socialized.

Many many compounds don't ever even make it to the approval process. When a compound is in Discovery it must pass a bunch of efficacy testing and some basic safety testing before being shoved over the wall into Development where the big money is spent. In Development they start with the real long term safety testing and clinical trials. I've worked in the industry for about 10 years in the Discovery side and so far I've had two compounds that I've worked on make it to the IND stage, a few more failed at safety testing Development stage and many never even made it to development because my Discovery safety testing killed them off.

Sorry for the digression. The second answer to whether or not a more socialized approval process would be acceptable would depend on where that would take place. In some places it already does, a lot of African countries accept the "risk" of drugs approved in the EU for significant price reductions on brand name drugs.

A fortune could be saved on drug testing if we could agree on a single testing protocol and a single agency. Right now when we decide to take a compound to the approval process we pick places to do it. Usually the U.S. and the E.U. to start with because they are big markets. If it looks like a drug is going to be successful there we consider going to Japan, Canada and China. Unfortunately you have to apply for approval in each country and each country has a completely different set of approval guidelines. We have an army of people who's only job is figuring out what studies need to be done for what country. Some countries won't accept the clinical trials unless new ones are carried out there.
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RaleighNCDUer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:28 PM
Response to Reply #11
15. If it is sitting on the shelf because it is not profitable, it is just as useless
as if it was sitting on a shelf because of corporate malfeasance.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:39 PM
Response to Reply #15
17. So who do you suggest fund the trials?
and who should hold the responsibiltiy for liability in the future if problems crop up for it's use?

I think it's the perfect opportunity for a public agency but the risk of failure during testing is massive. Right now it's just a single result. It might mean something but based on my experience the chances of success are very small.
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RaleighNCDUer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 02:05 PM
Response to Reply #17
19. The trials would be funded by the government, like virtually ALL
trials are - the reason they are not going forward is because it's not patentable, therefore there is no exclusive profit to it. Pharma companies are more than happy to get government grants and funding for trials of things they might make billions of dollars on, and if the new drug doesn't work out it is the government that takes the loss. But if the prospects for future profits don't exist, they won't waste their time on them.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 02:16 PM
Response to Reply #19
21. Pharmaceutical Companies
taking Government grants? I am aware of no Government grants for pharma clinical trials but would love to know about those that exist.

Shit we've been paying for them ourselves for years and didn't even know the Government was willing to foot the bill. Would the sales guy for the program explaining these secret grants happen to run around in a suit covered in dollar signs?

Other than orphan diseases I honestly can't think of an area where the government would be involved in any pharma endeavor.
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RaleighNCDUer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 02:39 PM
Response to Reply #21
22. Primary research is almost always done by universities - that's where
the government funding comes in. The pharma companies keep an eye on what is developing with the government funded research, and if it looks promising they will fund further trials - but the initial leg work is already done at government expense, so there is a very good chance they will develop viable drugs out of it. Of course, if the research is not able to be developed profitably, they ignore it.

That's what happens when you have MBAs running the show, instead of scientists.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 04:37 PM
Response to Reply #22
23. Not really
I know what you mean but it doesn't often work that way, at least not anymore, Universities got smarter. The work done in most University labs is basic research, not usually focused on pharmaceutical endpoints. Some of the basic research does pan out for future pharma development, stuff like Digoxin, Taxol and a lot of biological and natural molecules did start in basic research University labs and they do eventually move on to the pharma world. The discoverers of Digoxin and Taxol and I'm sure a lot more were totally and fully ripped off by the pharma companies so Universities got smart and instituted Tech Transfer Departments to make damned sure that doesn't happen any more. Now Pharma companies will fund University research if they see a promising endpoint too, that's how I got into the business.

When I was in graduate school I was working on a protein that we hoped could be an important veterinary and maybe human vaccine candidate. When I first started I was funded by a Government grant, it was basic research interested in the interactions of two different proteins. By the time we figured out that it could be a viable vaccine candidate my research project was fully funded by Novartis for the final two years, goodbye Government grant. That's not bad, it's the way it's supposed to work, somebody else can use the money. Governement grants have really been getting harder to get. My University negotiated a technology transfer agreement (all University research is the property of the University, not the researcher) with Novartis in which a percentage of future profits would be returned to the University and an even tinier amount to my supervisor and those of us on the patent in return for the protein and vaccine research. That was 10 years ago (damn but time flies) now and there still hasn't been a product put out for either vet or human therapy. Likely it's been dropped because it didn't function as well as hoped in the clinic. For Novartis it was a pretty small investment, University labs run on pennies compared to their in-house labs and it's good PR and recruiting for the pharma companies.

Most drugs are still discovered in house, either by the pharma companies or smaller biotech companies that then sell the technology to the larger pharma companies because the really expensive part of the drug development game is in development. Scale up of either small molecules or biological compounds from bench level gram amounts to hundreds of kilograms for clinical trials is a huge hurdle for poorly financed small companies and is never done in the University environment. I visited one of our Development sites and couldn't believe the size. I do cell culture work in discovery and buy media in 10 liter jugs, at the cell culture development site they had it brought in in tanker trucks that they hooked up to hoses. Clinical trials (phase I, II and III) cost up to hundreds of millions of dollars to set up, monitor and evaluate so again few biotechs and no Universities fund these. Even large pharma companies group together to share the risk if something goes down the drain at this stage.

Since I graduated I did a post-doc with an NIH funded Government lab and then moved on to two different small biotech companies that were heavily leveraged with single technologies. It's a fun job when you're single and can move around because it can blow up in a hurry. A large part of your "salary" comes in the form of stock, if it fails you can use it to paper the walls of the apartment. The first biotech job ended with a failed pre-clinical trial when the investment went away, I packed up and moved across the country to another biotech company, we sold that product to a big-pharma company. I took my stock option payout, got married and moved to big pharma because we wanted kids and I couldn't take that much personal risk anymore.

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RaleighNCDUer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 04:46 PM
Response to Reply #23
24. Thanks - I have no problem admitting to not being up to date on it, as
I'm not on the inside. I appreciate getting better information, and am glad to know that it is changing.
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sharp_stick Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 05:01 PM
Response to Reply #24
25. Universities had to get smarter
the pharma companies were basically raiding their labs and giving up next to nothing in return up until the 90's. It was well before my time but some of the stories were that university scientists were making individual deals with pharma companies for entire research projects in return for small payouts to keep the labs running.

I've been lucky, I've experienced the research world in all four realms (Academia, Government, Biotech, Pharma) which isn't something alot of people bother to do anymore.
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Jamastiene Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 10:34 AM
Response to Original message
4. K&R
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Junkdrawer Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 12:12 PM
Response to Original message
7. Perfect example of a capitalist contradiction. n/t
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ellenfl Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jan-06-10 01:24 PM
Response to Original message
14. k&r eom
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