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Cancer Drug May Not Get A Chance Due to Lack of Patent
theshowmecanuck writes to mention that in a recent study, researchers at the University of Alberta Department of Medicine have shown that an existing small, relatively non-toxic molecule, dichloroacetate (DCA), causes regression in several different cancers. From the article: "But there's a catch: the drug isn't patented, and pharmaceutical companies may not be interested in funding further research if the treatment won't make them a profit. In findings that 'astounded' the researchers, the molecule known as DCA was shown to shrink lung, breast and brain tumors in both animal and human tissue experiments."
Cancer Drug May Not Get A Chance Due to Lack of Patent
Note the word "may".
But because it's not patented or owned by any drug firm, it would be an inexpensive drug to administer. And researchers may have a difficult time finding money for further research.
Speculation.
Dr. Dario Altieri, of the University of Massachusetts, said the drug is exactly what doctors need because it could limit side-effects for patients. But there are "market considerations" that drug companies would have to take into account.
Buesiness fact.
Michelakis remains hopeful he will be able to secure funding for further research.
As anybody would.
"We hope we can attract the interest of universities here in Canada and in the United States," said Michelakis.
Excellent.
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The only news here is the drug itself and how things are moving along well. Yet, a speculation is reported as the main factor, when there is no supporting information for it. Did they even ask for funding yet? The researchers are taking the market into consideration, and the reporter seems to want to make a big deal out of it.
Even if the pharmaceutical companies do turn it down, and even if they do turn it down on the basis of no profit, it just means that the researches will have to do more presentation to find funding. If there is obvious promise in this (which there's have to be to get a pharmaceutical company to invest loads of cash) some organization, or college, or government grant will help pay for the studies.
Have you read my journal today?
If this really works, anyone who goes through the effort needed to conduct FDA trials and bring the drug to market will immediately face competition from generic drug makers who've invested very little in bringing their product to market. If it were patented, then it would become profitable to spend the money to show that it really does work. Otherwise, the company doing the leg work won't have the leg up on their competition.
Wouldn't companies like Barr Labs, whose entire business model is to develop drugs that have fallen out of patent protection, be interested in developing a drug that's not patent protected? It could be a major windfall for them since they're able to develop a new drug before existing brands can be established in the space. The only trick I see is that Barr Labs isn't as used to dealing with the Federal Drug Administration for drug approval, so it might take some hiring in key areas of the company. But these don't seem like insurmountable challenges given the potential market size and the business model match with existing out-of-patent drugs.
my blog
This just in: developing medecines takes work, and work costs resources. Anybody who can think of a better way to provide resources to the people interested in developing medecines, besides patent royalties and the like, please come forward.
And anybody who thinks that people should use their own resources to develop medecines, and then not ask for anything in return when they offer those medecines to the public, are kindly invited to drop whatever they're doing right now, that puts food on the table and a roof over their heads, and devote everything they have to developing medecines for free.
Any sufficiently well-organized community is indistinguishable from Government.
then public labs should. This is a matter of public health, therefore the state should fund the research. If only because, if this molecule has potential, the taxpayer money they put into the research will be peanuts compared to what health care providers will have to pay for licensed medicines. I.e., for the state, this is a matter of making long-term economies, not even a humanitarian pursuit. But of course, our dear leaders have to be willing to pay a miser upfront to avoid paying billions to pharmaceutical companies 10 or 20 years down the line.
I just don't understand this country anymore: have people completely forgotten we have (or should have) public labs to do the kind of research short-sighted profit-oriented companies won't do? apart for military technologies, it seems society has decided to put its future advances squarely and solely in the hands of the corporate world. This is sad.
"A door is what a dog is perpetually on the wrong side of" - Ogden Nash
The "big" thing about the Losec medication wasn't really the drug itself, but the way it was delivered to the body iirc. And although AstraZeneca eventually 'lost' the patent (ok, it expired) on the active substance, a lot of other patents regarding the drug delivery were still in place, making them tons of cash.
So I do believe this is just a scare from the pro patent lobby. I'm sure there are a lot of companies working on this right now to see if it's possible to make a useful drug out of it. Even if the drug itself can't be patented there's probably a whole lot to be learned from it, possibly to be used in other drugs that can be patented.
I wouldn't worry. If it does cure cancer, we'll get the drug eventually.
You are not entitled to your opinion. You are entitled to your informed opinion. -- Harlan Ellison
Government funded research.
A lot of people on Slashdot may disagree with this, but the "free market" is not the solution to everything.
According to the article dichloroacetate is relatively easy to obtain. "The compound, which is sold both as powder and as a liquid, is widely available at chemistry stores." I'm sure a pharmacist trained in the art of mixing compounds could formulate it to doctor's specs.
If worse comes to worse you raid your old "Super Advance Kiddee Chemistry Set" and dose yourself.
It is by the juice of the coffee bean that thoughts acquire speed, the teeth acquire stains. The stains become a warning
When the free market fails, as in this case, why not let government do it? Most major scientific breakthroughs have come from government funding.
- None can love freedom heartily, but good men; the rest love not freedom, but license. -- John Milton
here
-mcgrew (my computer is broken):
Re:Am I missing something?
Yes.
It's not that people wouldn't pay; it's that without a patent, there's no protection for the manufacturer. Company A pays for the R&D on the drug, and then they go through years of clinical trials to clear the regulatory agencies. This costs $100mm to $1bln for most drugs. If there's no patent protection, Companies B through H can produce generic equivalents, prove equivalency to the regulators (at a cost of a few 10s of millions), and then undercut company A on price.
In the short run this appears to benefit the consumer. In reality however, Company A is too smart to give a free ride to their competitors. The drug never gets developed and more people die.
Even if the companies do turn it down they will get a further crack at it. Courtesy of the Byah-Dole act most publicly funded research (especially drug research) in the U.S. can later be "bought" by private companies who may then claim "intellectual property" on the fruits of the public's labors. It is this law that allows both AZT and Viagra (developed with funding from the National Institutes of Health) to be considered "private" property and for the companies to charge the people who invested in their development for their use.
The practical upshot of this is that if the drug does go to the universities to be developed it would be following the normal track of most medical research. And if any patentability (say on dosage levels) does show up the companies can always buy it then.
We don't *know* for sure yet that it really works. We don't know for sure that it may not have some bizarre side-effect in some patients. Answering those questions to the degree of certainty that will convince the FDA to let any US doctor start prescribing it to patients will take huge amounts of time and money. And once one company has expended that effort, *anyone* can sell the drug--and all the companies that didn't fund the testing will have the advantage that they don't need to set a price that will recoup the investment in testing.
So the market will penalize the company that actually does most of the work needed to bring the product to market. As a result, no company will do that work.
That's the problem that patents on pharmaceuticals are intended to fix, really: they fund the testing required to establish to the government's satisfaction that the drug is safe and effective, by giving a temporary monopoly to a single company, as an incentive for that company to invest in the testing.
We think of patents as existing to reward that "ah-ha" moment of insight that produces an original idea. But often such insights are cheap, and occur to multiple people simultaneously. What we really need the patent monopoly for is to encourage the research required to bring a product to market, whenever that research is something that, once done, any competitor could use for free.
Cuba has a large, thriving and internationally recognized cutting-edge pharmaceutical and biomedical research industry. They specialize in developing and distributing drugs to the 99% of planet Earth that can't afford $5/day to get harder erections. They generally research based on the commonality and severity of particular diseases, and then try to find exceptionally low-cost ways to solve them better. Ironically enough, it's quite profitable since selling tens of millions of pills to entire continents at 1% profit can add up pretty quickly.
Recursive: Adj. See Recursive.
So yeah, there's no financial incentive. So what about in other countries? Will it get developed and tested elsewhere? And if successfully tested, will it become legal in the U.S.?
What we're talking about is the essential blocking of just one path by which a drug gets to patients. Is there only one path? And if there's only one path, *THEN* we have a serious problem where the industry is truly getting in the way of a better existance for humanity.
I am not surprised. I watched my mother in law die of lung cancer a few years ago. Her best (insurance-funded, of course) option was radiation & chemotherapy. A few months ago (July-August), I watched my father go through practically the same thing. Once again, his best (and also insurance-funded) option was radiation & chemotherapy. One bill I saw, that he had to fork out $225 for (co-pay for it being over $20k), was almost $21,000. Why is there not a cure and treatments are our best option? The fat ass American medical industry and the pharmaceutical industry can charge 10K per session to the Insurance Industry, who just plain rips off the American people. It would be such a wonderful irony to see something that isn't patented become a cure...then it would be available to EVERY F*CK*NG PERSON who could throw down a few bucks for the cure, instead of having to rely on the bullshit fat ass Insurance, Medical and Pharmaceutical industries to give us these bullshit treatments that prolong the agony. There would be fierce competition for sales of this cure, therefore making the price of it affordable without the necessity for the Insurance company to intervene.
I *STILL* have cancer to this day because of the bullcrap like this.
IMHO as a cancer patient, the reason why there's no 'cure' to different types of diseases (including diabetes) is because the pharmaceutical companies make billions of dollars a year keeping us sick. If there was a cure, there goes their profits.
I would like to see a law passed that says that if a cure if found and not distributed within a viable time frame to the general public (lets say 10 years), the company can be charged with genocide.
Will it happen? Hell no. There's too many people in power in Washington who owns stocks in these companies.
- Just my $0.02, take with a grain of salt, your mileage many vary...
- Just my $0.02, take with a grain of salt, your mileage may vary.
It's not a broken system. On my local news (Edmonton, home of the UofA) they are specifically NOT including drug companies in funding the trials, because they want the drug to be cheap.
FTA:
"A small, non-toxic molecule may soon be available as an inexpensive treatment for many forms of cancer, including lung, breast and brain tumours, say University of Alberta researchers."
Sir Frederick Banting, (another Canadian) did the same thing with his patent for Insulin, so that drug companies would never have a monopoly on something needed for people to live.
"History doesn't repeat itself, but it does rhyme." Mark Twain
How in the world is this insightful? You are recommending to people who have no clue what the consequences of just going out and taking some medication might be to give it a whirl since it isn't a controlled substance. Regardless of how we would all love to find out that you could just go to the grocery and grab a bottle of "No More Cancer," suggesting that people experiment on themselves is NOT a reasonable suggestion. Science is not the culmination of anecdotal evidence, just because it worked for someone does not mean it will work for you nor that what you think happened is actually what happened (e.g. just because you no longer have cancer after giving it a try doesn't mean that it was what caused the remission) Giving out advice as you have should be done with great care which you have not displayed.
The problem is precisely the LACK of a patent system for this type of scenario. This drug shows exactly what would happen WITHOUT a patent system - no one would have an incentive to develop and test new drugs, because anyone else would copycat without the upfront costs, and win therefore win the price war.
...where we believe that governments have a responsibility to set policy for, and even fund, public health initiatives that are not necessarily advantageous to any given industry sector or corporation.
The research in question was funded by a Canadian federal government agency, and I'm certain that one or two well-funded, non-profit and/or public sector agencies will step up to the plate to study whether the proposed treatment is safe, and if so, some smart non-intellectual-property-driven and yet profitable organization will market it.
Well, if this is the case, why can a US institute like NIH, which I think gets a bit of govt. research funding, conduct the trials for drugs that are not patentable, but, might be of benefit to humans...and if it passes...then all drug companies are free to manufacture them?
If this couldn't be done, then possibly the govt. needs to set up a system for testing drugs that the drug companies won't/can't push through due to the cost with no patent protections.
Light travels faster than sound. This is why some people appear bright until you hear them speak.........
The people are willing, but our governments are not.
I have long argued that the drug companies should be sidelined in favour of public money ( and lots of it ) being invested into medical research, with the benefits enjoyed by all. The problem is that the pharmecutical industry is incredibly powerful ( and rich ), and prevent our governments from performing any public research, insisting that the 'market will provide'. This story points out the bullshit level in this case. The market does not provide anything for society other than those things which make the most profits for market players. If we want the best possible medical technology, and for it to be accessible by all people and not just those with the cash, then we need to have massive public investment, and also consider specifically excluding medical technology from patent law.
Yes it does. And that system is cheaper per capita, and results in Canadians having a 1.5 year longer average lifespan.
n _health_care_systems_compared
http://en.wikipedia.org/wiki/Canadian_and_America
"History doesn't repeat itself, but it does rhyme." Mark Twain
Actually, if you read the article (I know bizarre), you would have know that it is already and FDA approved drug and is actively prescribed. It has some side effects but nothing horrible. Since it is already approved, getting it cleared for use in a an additional capacity is much easier since it has been proven safe for human use. The only thing that needs to be proved is effecacy.
Sorry my bullshit sensor overloaded.
Actually, you are overstating the work which the drug companies engage in. Most of the research is done in academia, under federal funding. But not quite enough to quality a drug for FDA approval. Then some drug company buys the rights to something that it considers promissing, after most of the risk is gone. It then runs the final trials, etc., and gets the patents.
Is it any wonder that the drug companies have such remarkable profits.
Personally I feel that the solution here is to forbid exclusive or discriminatory licensing of research developed with federal money. This would probably mean that research trials would need to be carried further (i.e., more up front investment), but it would prevent the monopoly pricing that is currently the rule. (If you don't think my scenario is common, then what I'm proposing wouldn't very often change anything.)
I think we've pushed this "anyone can grow up to be president" thing too far.
Since DCA is already on the market for the aforementioned mitochondrial dysfunction maladies, there doesn't need to be any testing. You just administer it "off label", if you dare. The problem is purely a legal one, figuring out the liability if you get the dosage wrong. The people who are currently making DCA have little incentive to fund that sort of thing because they're making next to no money on it already.
This is a job for a different business model, that's all.
Perhaps Health Insurance Companies could fund this type of research - they would stand to benefit directly due to the high costs associated with cancer treatment.
You had me at merlot
It's legal, but the obvious concern is liability. And that's a huge issue in the United States. Obstetricians now do a lot of C-sections. Not because it's better or safer (it's probably not), but because trial lawyers were very successful over the last 10-15 years in painting the C-section as "safer" anytime something went wrong with a delivery. Without FDA approval, you're asking for your medical practice to be annihilated by any hungry lawyer that comes along. Moreover, the drug manufacturer is begging for annihilation like Dow Corning. Who cares about the science or the logical merits, there's billions to be made in law suits. Like it or not, patent protection seems to be the best model we've got for developing innovative new drugs. (No, I don't think software patents are a great idea). I can't see other countries with different regimens that have produced lots of innovative drugs like the US. And and incredibly slow FDA trials seem to be the best model so far for preventing bankruptcy. (Not, it should be said, for the patients as witness the relaxation of some rules in HIV and HCV treatments). I sadly can't see any effective model that beats out drug patent protection. If you can, name one in operation that is producing superior results. I can certainly see a number of models (see Canada, much of Europe) that beat out FDA trials. Holmwood
If any government-funded entity did this, the patent-funded corporations would scream "unfair competition!" and send their hordes of patent-funded lawyers and lobbyists to get them shut down.
Big money defends itself.
But if the defense lawyers just say "Well, you had no plans to develop it yourself, and besides, once it is developed, we are handing out the blueprint for free.", then the patent-funded lawyers ought to have no case. Whether or not they do have a case is a matter of what the laws on the books are, and I don't know that. But, if the laws on the books say they do have a case, then those laws have become a problem and need to be changed. The lobbyists might be more of a problem, which perhaps merely indicates that we need more restrictions on corporate lobbying.
SIGSEGV caught, terminating
wait... not that kind of sig.
In the case of DCA, if DCA is a cheap and inexpensive way of treating cancers, then medical insurance and HMOs will have an economic incentive in developing it further because it saves them money.
Even if there is no economic incentive for drug companies or HMOs to develop a drug like DCA, it can always be tested and approved based on tax-payer funded trials--in the end, that will save the tax payers a lot of money compared to having the drug patented and sold at a premium. Furthermore, often, such drugs somehow manage to get used even without approval through various programs and channels.
I have my doubts that DCA is the miracle drug the article suggests, but if it is, it's a good thing that it isn't patented: more people will be able to use it and it will cost less.
Not really. Botox is approved for muscle spasms, and gabapentin for seizures. The vast majority of uses are off-label; it doesn't seem to have stopped doctors from prescribing the drugs. While I'm sure there are liability concerns, I don't think they're the barrier you make them out to be for prescribing drugs off-label.
Laws do not persuade just because they threaten. --Seneca