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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."
If this *REALLY* works, wouldn't people be willing to pay for it?
If people are willing to pay for it, how come somebody isn't willing to profit from it?
here
-mcgrew (my computer is broken):
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.
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 if this medecine is so wonderful, and developing medecines for profit is so evil, why doesn't this University start mass-producing this medecine and giving it away for free?
For one, it would be illegal since the thing isn't FDA approved. And what does it take to get FDA approved, you ask? Years of studies and many millions of dollars. See many of the other posts on the topic, I'll not repeat them, but the basic point is that they'd have no hope of recouping their investment simply because tons of other companies would drive the price of the drug through the floor.
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.
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
Go ahead... name a few significant drugs discovered/invented in Socialist countries.
Meningitis B vaccine, from Cuba. In fact, Cuba has a world class biomedical industry.
I was not aware that the drug is already in use. If it is, you don't actually have to do anything: you can just get doctors to prescribe it off-label. (That's in the US; given that this is Alberta I can't say what the rules are.) You'd end up doing a Phase IV trial, which can be a lot cheaper if you can just get doctors to send in data.
Or you can patent one of the production processes for it.
Someone mentioned the inventor of insulin trying to ensure a "no-monopoly" situation, but since the advent of human insulin produced by genetically engineered bacteria (as opposed to from the pancreas of slaughtered cows/pigs), a select few companies (Eli Lilly and Novo Nordisk and that's about it with one exception) have dominated the insulin market since the 1970s (Insulin was discovered in the early 1920s, by the way) due to patents on:
Methods of producing insulin (specifically recombinant DNA origin insulins)
Methods of tweaking insulin to be absorbed/used by the body over a longer period of time by adding stuff to the injected mixture (Lente, Ultralente, NPH, etc)
Methods of producing insulin with "faster than natural" activity profiles by tweaking the molecular structure itself (Humalog and Novolog)
Methods of producing insulin with extremely long "peakless" activity profiles by a combination of the above two techniques (Lantus and Levemir) - BTW this is where the one exception to the Lilly/Nordisk dominance is. Lantus is made by Aventis.
From one "unpatented" drug that according to this article will not have an interest from big pharma, history shows that global market dominance can still be established. I have a feeling drug companies right and left will be racing to tweak this new drug to make a better version or better production process (which happens to be patentable).
retrorocket.o not found, launch anyway?
this is something that kills tumors in-vitro,
Actually, according to this more thorough article, the drug has also proven effective is mouse models.
Granted, this still isn't the same as a human trial, but it's a far cry from simply killing cancer in a petri dish.
As for the notion that the unwillingness to develop a drug in the absence of patent protection somehow is an argument against patents
Actually, it's more of an argument against privately funded drug development, as it's pretty clear that an unpatentable drug, no matter how effective, isn't useful to a company who's sole purpose is to make money.
If somebody wants to sell this to treat cancer, the FDA is going to require 800 million dollars worth of Phase I, II, and III clinical trials before it allows the claim.
Not AFAIK. My understanding is that the FDA will fasttrack an already approved drug (such as this one) for alternative uses. Since safety is already proven, the only thing necessary is efficacy trials (so far as I know).
Fortunately, this makes it far more likely that a non-profit (or the government, who is obviously interested in lowering healthcare costs) could pick up the table to fund the research.
I believe this compound has been in use for a long time, albeit for other higher-level purposes. This is merely a different application of the same compound. It's almost like taking asprin for heart disease instead of pain. Since the compound already exists in a FDA approved form, why then would the researchers have to go through the same trouble again? At the very least, they'd be able to cite the previous studies done for FDA approval, and that should speed up the process considerably.
Given this, I'd think it'd be easy for companies that make generics to start selling this.
I think any funding would be going into testing to further medical knowledge rather than to attain any form of approval for use.
"If a nation expects to be ignorant and free in a state of civilization, it expects what never was and never will be."
Maybe you should read your own references. To wit:
"However, concern about DCA toxicity is predicated mainly on data obtained in inbred rodent strains administered DCA at doses thousands of times higher than those to which humans are usually exposed."
And
"As a medicinal, DCA is generally well tolerated and stimulates the activity of the mitochondrial pyruvate dehydrogenase enzyme complex, resulting in increased oxidation of glucose and lactate and an amelioration of lactic acidosis."
As for your other "source" (if one can call About.com a reliable source), the last sentence is telling: "The findings show that this side effect of DCA outweighs any potential beneficial effect of the medication in treating MELAS." In other words, DCA isn't good for people with the exceedingly rare MELAS SYNDROME.
The pursuit of absolute tolerance leads to the most rigorous and ludicrous intolerance. - REX MURPHY
I heard about the Vioxx situation on NPR's Science Friday, that it was a confluence of bad events. The drug had a very narrow group of indications but was practically advertised as a general-use product. There are suggestions that off-label prescriptions were strongly recommended, carelessly using it to treat illnesses for which it was not tested. In some situations, having the drug is actually better than not having it (a debilitating painful illness vs a very small risk of death), but there apparently is no good way to restrict the use so that only the people that really do desperately need it will get it.
It's basically a case of too much of a good thing. IIRC, there are were suggestions of allowing restricted use but I don't remember what the deal is.
Well, then he's trolling. 'Nationalized Healthcare' means we pay for it through our taxes, so price does matter. Many cancer treatments can run $12,000 a month, and are not covered by many provincial healthcare plans.
There are many things we must pay for, out of pocket. Perscription drugs and non-approved cancer treatments are two of them.
"History doesn't repeat itself, but it does rhyme." Mark Twain
Actually the average Canadian still has to pay for their drugs. Exceptions include people on income assistance, pensioners and perhaps others.
https://en.wikipedia.org/wiki/Inverted_totalitarianism
If'd you actually bothered to read the article on Wikipedia on Insulin, you'd have learned that Frederick Banting was in fact the first person to extract the active agent from the islets of langerhans in the pancreas. He didn't know what it was (insulin was identified as the active ingredient of the extract some time later) but Banting was responsible for developing the first effective treatment for diabetes mellitus and he shared the 1923 Nobel Prize in Medicine for the Discovery of insulin with J. R. Macleod (who identified the insulin molecule as the active ingredient).
Even someone who makes six figures may get their drugs paid for if they are on extremely expensive treatments. There are also other types of coverage, such as pallative and mental health, which will pay 100% with no deductible needed for specific drugs.
Lowest Cost Alternative
Also, consider this from JAMA: "None of the first-line treatment strategies-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers (CCBs), -blockers, and angiotensin receptor blockerswas significantly better than low-dose diuretics for any outcome."
The diuretics they refer to cost about a penny per pill. Some of the other treatments cost more than a dollar per pill.
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