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."

Generic drug manufacturers

[panaceaa]

Wouldn't companies like Barr Labs [yahoo.com], 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.

Private enterprises won't develop the cure?

[Rosco P. Coltrane]

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.

Get out your chemistry set

[Hoi Polloi]

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.

Re:This just in...

[Billosaur]

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.

How about taking the money Big Pharma uses to line the pockets of its CEOs and the egregiously large profits these companies make and putting the bulk of it into research and production? How about diverting resources and money from male impotence drugs, since I suspect far more people have cancer than there are men who can't spank the monkey.

Re:Generic drug manufacturers

[jfengel]

It's not just their lack of expertise. Getting a drug through level 3 trials is expensive: it takes a lot of (often paid) subjects, and doctors and nurses to spend time with those subjects, and a battery of tests to be done on those subjects. This money is spent over years to ensure that the pill is safe and effective before you have even a single paying patient. Paying the subjects is actually the cheap part.

And there's the possibility that once they've spent all that money, it could fail. Maybe the pill just doesn't work. Maybe there are side effects: look at the way Merck is getting hammered for producing a highly effective pill (Vioxx) that just happened, to, well, kill a few people.

Barr makes their money by letting somebody else pay for all that, and then coming in a few years later and charging a lot less. It's the usual problem: the second pill costs $.49, but the first pill costs $75,000,000.

Re:Moo

[Anonymous Coward]

501c3's around cancer research should fund this.

Re:Private enterprises won't develop the cure?

[dpilot]

You seem to forge that this is Slashdot.

Remember, "public" means "government", and "government" is the stupidest there is, unable to do anything at all right. All such intelligence and acumen reside with "business". If only "government" would get out of the way with silly regulations, operating under the principles of the "free market", the profit motive would induce "business" to do the right thing, with the end result that we'd all be better off.

Silly things like effective medications that are inherently low-cost are an aberration, and don't really exist.

Re:Private enterprises won't develop the cure?

[Otter]

If only because, if this molecule has potential...

As with every "New Miracle Cure For Cancer!" story here (this is, what, the fourth one of the year and we're barely halfway through January), this is something that kills tumors in-vitro, published in a respectable but unremarkable journal and then hyped by an overexcitable univerity PR department. There are literally dozens of results like this every week, virtually all of which go nowhere.

As for the notion that the unwillingness to develop a drug in the absence of patent protection somehow is an argument against patents -- honestly, I can't get my brain down close enough to the level of such idiocy to reason with it.

Oh dear lord, here come the loonies.

[JonTurner]

>>When the free market fails, as in this case, why not let government do it? Most major scientific breakthroughs have come from government funding.

That's correct. The free market *HAS* failed -- the government is interfering by their over-regulation. Thank the FDA and trial attorneys for making new drug development so cost-prohibitive.

But that's not what you meant, was it? You seem to have this idea that all good things come from government. "most major scientic breakthroughs"?? It is to laugh.
Well, then, it should be easy for you to provide a list of drug discoveries that came from government funding. But even if you could (and you can't b/c it's not true) that's not due to socialism.
I'm calling your bluff. Go ahead... name a few significant drugs discovered/invented in Socialist countries.
__________
__________
__________

From what I've seen, the West invents the drugs and the Socialist/Communist nations simply copy the work.

Naturally!

[mpapet]

If they can't protect their market position, they won't make the investment. It has nothing to do with how many people's lives may be extended.

This is how deregulated industries benefit consumers. Ohh wait...

Re:How about socialism?

[spun]

The market would have failed far earlier without regulation. The free market system breaks down in the face of externalities, imbalanceof information, or natural monopoly. In this case, the issues are externalities and imbalance of information. The externalities are the potential harms caused by poorly tested drugs, and the imbalance of information is due to the fact that no average buyer will have nearly enough information to make an informed decision about what drug to take. Thus the need for government regulation.

Good thing this is in Canada...

[Arrgh]

...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 [cihr-irsc.gc.ca] was funded by a Canadian federal government agency, and I'm certain that one [bccrc.ca] or [ocrn.on.ca] two [cancer.ca] 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 [canadiangenerics.ca] organization will market it.

Well there are non profit Pharmaceutical Companies

[Anonymous Coward]

In July of 2000, Dr. Hale founded the Institute for OneWorld Health, the first nonprofit pharmaceutical company in the United States. Its mission was to develop safe, effective, and affordable new medicines for those most in need.

Drawing upon gifted scientific minds and the innovative business model they had created, Dr. Hale and her colleagues set out to develop the pipeline of potential drug leads into approved new medicines at a fraction of the cost of conventional pharmaceutical development. To ensure success, the team stressed partnership and collaboration with industry and international research institutions. To ensure affordability, they sought donated and royalty-free licensing of intellectual property and identified research and manufacturing capacity in the developing world.

http://www.oneworldhealth.org/ [oneworldhealth.org]

A perfect match I'd say - These guys could produce and market a cure for cancer they can make a little money on it here in our part of the world, while using the profits let's say a couple of percent, on making drugs for other diseases available in the developing world... and hey whadyaknow - They also have cancer in developing countries!!!

Cheap

[drooling-dog]

The other problem is that dichloroacetic acid is a very cheap and easily produced chemical, on the order of things like aspirin and vitamin C. Nobody's going to be able to charge $10,000 for a month's supply (whatever that is) when you can go out and buy the raw compound for $30 a kilogram or so.

Maybe the best chance (though a dangerous one) for it is for people to just start using it as an unregulated "nutritional supplement"; then maybe the new NIH institute that tests "alternative" therapies (I forget its name) will have to conduct the safety and efficacy trials.

Are you trying to troll me?

[Dr Caleb]

Yes it does. And that system is cheaper per capita, and results in Canadians having a 1.5 year longer average lifespan.

http://en.wikipedia.org/wiki/Canadian_and_American _health_care_systems_compared [wikipedia.org]

Re:Am I missing something?

[dbrutus]

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.

Re:Am I missing something?

[6ame633k]

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.

In other words

[j_w_d]

Patent lawyers nixed because they won't get a cut. The reasoning is beyond specious. If you consider that drug companies insist that patents are necessary to pay back tremendously expensive research, then you hear, "sorry, we can't produce the drug. It'll be too cheap."

The idea that a lack of patent would prvent production is silly. Look at aspirin. It is made competively by any number of drug companies and lack of patents doesn't reduce aspirin's availability.

Re:Am I missing something?

[Fred_A]

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.

Well, yes, but on the other hand a lot of money is saved on patent fees. Stop looking at the dark side of things. Sheesh.

For ages lots of people have fought for state funded research in drugs in Europe for this exact reason (well, among others, notably the fact that very few labs actually do any research any more). Affordable treatment (in Real Life, between 40 and 60% of the budget of a given medicinal drug is marketing related, this before profit is even factored in).

Bah, anyone who's had to do with the inner workings of a pharmaceutical lab knows that there's nothing to expect from them anyway. New treatments will come from other directions. The labs mostly recycle older molecules nowadays. A lot of them are among the most cynical corporations on the face of the planet (you thought the tobacco companies were bad, you've never met anyone from a pharma lab).

Re:Am I missing something?

[erroneus]

Now *THAT* is something I could get behind.

Right now, the healthcare system is being driven by those who make the most profit from it. There's lots of incentive to treat with no incentive to cure.

On the other hand, medical insurers have LOTS of incentive to promote preventative and curing meaures. I'd like to see some sort of requirement for medical insurers to grant portions of their windfall profits for medical research... give them some sort of tax break or something as compensation.

What About..

[Xybot]

...Allowing anybody with terminal cancer to be prescribed this drug as long as they sign a waiver against side effects or other health consequences and agree to participate in a scientific study of health effects. The drug is already in production, and has passed FDA approval (albiet for a different condition). Believe me a person who is suffering from terminal cancer wouldn't even think twice about accepting this, what's their alternative?

Re:Am I missing something?

[The_Wilschon]

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.

bullshit

[oohshiny]

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.

Quackery.

[Grendel Drago]

Yes, but the benefit of this particular research is that it's actual science, while "BarleyGreen" is quackery [quackwatch.org]. And while some argue that it's essentially harmless and might give people hope, quackery kills people [blogspot.com]. Take that shit somewhere else.