Slashdot Mirror
Cheap Cancer Drug Finally Tested In Humans
John Bayko writes "Mentioned on Slashdot a couple of years ago, the drug dichloroacetate (DCA) has finally finished its first clinical trial against brain tumors in humans. Drug companies weren't willing to test a drug they could not patent, so money was raised in the community through donations, auctions, and finally government support, but the study was still limited to five patients. It showed extremely positive results in four of them. This episode raises the question of what happens to all the money donated to Canadian and other cancer societies, and especially the billions spent buying merchandise with little pink ribbons on it, if not to actual cancer research like this."
There is no money in a cure....
Drug companies can patent just about anything, so long as they do the research and file the patent. Example: a drug called Finasteride 5mg, which treats enlarged prostates, was discovered by its maker, Merck, to stop male pattern baldness. But the patent for Finasteride is expired. Merck did some studies and found that a 1mg dose was enough to treat baldness, and got the 1mg dose (Propecia) approved by the FDA. They patented the 1mg dose and to this day, 1mg Finasteride costs $60/month ($2 per pill), whereas 5mg Finasteride pills (the same drug, different dose) is basically free from generic drug manufacturers.
The moral of the story is that he who does the research gets the patent, even if the chemical itself cannot be patented.
A slashdotter who didn't build his own computer is like a Jedi who didn't build his own lightsaber.
>> It also raises the question of where all the money donated to Canadian and other cancer societies, and especially the billions spent buying merchandise with little pink ribbons on it goes, if not to actual cancer research like this."
Answer:
http://www.preventcancer.com/losing/acs/wealthiest_links.htm
http://www.sciencedaily.com/releases/2010/05/100512141909.htm
Generic Drug May Be Potential Treatment for Deadly Brain Cancer
ScienceDaily (May 13, 2010) — Medical researchers at the University of Alberta have reported evidence that the orphan generic drug dichloroacetate (DCA) may hold promise as potential therapy for perhaps the deadliest of all human cancers: a form of brain cancer called glioblastoma.
The report is published at the journal Science Translational Medicine, a journal of the American Association of the Advancement of Science.
In 2007 the U of A team led by Dr. Evangelos Michelakis, published evidence that DCA reverses cancer growth in non-human models and test tubes. The team showed then that DCA achieves these antitumor effects by altering the metabolism of cancer. By altering the way cancer handles its nutrient fuels, specifically the sugars, DCA was able to take away cancer's most important strength, the resistance to death. Since then, several independent groups across the world have confirmed the Alberta team's findings. In December 2009, the editors of "Science" predicted that cancer metabolism is one of only 5 areas across all scientific disciplines, to "watch for major breakthroughs" in 2010.
The U of A team set out to show that the way that DCA works in actual patients is the same with the way it works in the lab. In addition, researchers wanted to show whether DCA is safe and possibly effective in very sick patients with brain cancer.
By extracting glioblastomas from 49 patients over a period of 2 years and studying them within minutes of removal in the operating room, the team showed that tumors respond to DCA by changing their metabolism. Then, the team treated 5 patients with advanced glioblastoma and secured tumor tissues before and after the DCA therapy. By comparing the two, the team showed that DCA works in these tumors exactly as was predicted by test tube experiments. This is very important because often the results in non-human models tested in the lab do not agree with the results in patients. In addition, the team showed that DCA has anti-cancer effects by altering the metabolism of glioblastoma cancer stem cells, the cells thought responsible for the recurrences of cancer.
In the 5 patients tested, the drug took 3 months to reach blood levels high enough to alter the tumor's metabolism. At those levels, there were no significant adverse effects. However, at some of the higher doses tested, DCA caused nerve malfunction, i.e. numbing of toes and fingers. Importantly, in some patients there was also evidence for clinical benefit, with the tumors either regressing in size or not growing further during the 18 month study.
No conclusions can be made on whether the drug is safe or effective in patients with this form of brain cancer, due to the limited number of patients tested by the study's leads Drs Michelakis and Petruk. Researchers emphasize that use of DCA by patients or physicians, supplied from for-profit sources or without close clinical observation by experienced medical teams in the setting of research trials, is not only inappropriate but may also be dangerous. The U of A results are encouraging and support the need for larger clinical trials with DCA. This work is also one of the first in humans to support the emerging idea that altering the metabolism of tumors is a new direction in the treatment of cancer, Michelakis and Petruk said.
The research team hopes to secure additional funding to continue the ongoing trials with DCA at the University of Alberta. Further studies would include more patients with brain cancer, and test the combination of DCA and standard chemotherapies, eventually including patients from other academic health sciences centres.
One of the intriguing features of this work was that it was funded largely by public donations, including philanthropic foundations and individuals. In addition, it received strong support by Alberta public institutions, both the University of Alberta and Alber
Notice, though, that the March of Dimes didn't try to block the Polio vaccine, or lobby against it in any way.
Instead, they switched to other things to wipe out, and have apparently made great progress on all sorts of various birth defects now...
If the masses can keep you down, you're not the Ubermensch.
A lot of the big charities these days seem to be focused on "awareness" rather than "finding a cure". This basically sounds like giving money to these people so they can run more ads to get more money. At what point do we decide people are "aware" enough and start actually trying to cure these diseases? I don't care how many people are aware of breast cancer, I care how fast it takes to come up with a cure for breast cancer.
The big offenders I've seen are breast cancer awareness and autism awareness. Why do we need to give money to make people more aware of these conditions? Everyone is already as aware as they need to be! Stop spending money on awareness and start spending it on research!
Of course, once a charity reaches a certain size, its primary goal becomes self-preservation, and finding a cure for these things would threaten that goal.
Money spent on e.g. breast cancer awareness goes towards raising awareness of breast cancer, not to finding a cure or even a treatment. It's the same with every other X cancer awareness non-profit charitable organization.
Also, the amount of money for awareness isn't very large compared to the amount of money required to do human-based research. My small research lab has a relatively modest budget of USD 250k per year (*thank* *you*, NIH, and *thank* *you* to all you taxpayers out there). The total cost my institution will bill the government for my lab over the five years of the grant I have is about $2.25 million, including overhead. Now a couple of million dollars is a gob-smacking amount of money by most individual people's scales, but it's just one small biology lab. We're working with test-tubes, not humans ... at least not yet.
A hoo-ha-break-out-the-champagne fund raiser would net $1 million. That's a fantastically successful fund raiser. But it would only run my lab for about two years. If I wanted to do a Phase-I clinical trial, it would take two-to-three times that amount of money. Phase-II would be about ten times that. Phase-III is not something that could be done at my home institution alone.
So public-based fund raising for breast cancer, autism, kidney disease, coronary disease, glaucoma, what-have-you, is wonderful. But it's on the wrong scale to fund research or human drug testing. I'm deeply impressed that anyone was able to raise enough money for an independent drug trial.
Put my fist through my alarm clock with its ding-dong death inside my ear. - The Blackjacks.
My baby brother has autism, he's 18 and operates at a 12 year old level. He's not stupid, but he is definitely developmentally retarded.
Seriously, if you don't think that autism is a retardation then there is something really wrong with your world view.
Heck, just look up the words.
Autism == a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior.
Impair == make worse or less effective
Restrict == restrain within bounds; to limit; to confine;
Restrain == to close within bounds, limit or hold back from movement;
Retard == cause to move more slowly or operate at a slower rate
Quit trying to convince yourself that it's not as bad as it is. Accept that it's bad, and then fix it.
Denial on your part just limits the possible solutions that you will aloow him to enjoy.
Basically this is a problem with corporations. They have no morals. The law treats them as pseudo-humans, but they are not.
In fact, by most definitions, they are psychotic.
They are incredibly paranoid (with trained attack lawyers), delusional (almost any management meeting), appalling bullies (Microsoft et al), manipulative (marketing, more lawyers), small-minded (the next quarter is the only thing).
Do I need to go on? And yes, drug companies are among the worst - but think of tobacco companies, oil companies ...
Company law needs to change in some way to make incorporated entities be more responsible.
But how?
"Cats like plain crisps"
In 2008 I learned I had failed treatment for prostate cancer (72GY radiation & 2.5 years triple hormonal blockade). The disease was metastatic in skeleton and soft tissue with a PSA doubling time of 24 days which is very dangerous. Severe bleeding and bone pain quickly developed. Chemotherapy does not extend survival time for prostate cancer patients, moreover it has serious side effects. There was no clinical trial of DCA for prostate cancer. I decided to self-administer Sodium Dichloroacetate (DCA).
DCA is an orphan drug which for 30+ years has been safely used in the U.S.A. to treat infants born with congenial lactic acidosis; also to treat cerebral ischemia among other conditions, so it is well described in the literature and the side effects are understood. It is not completely benign but is far safer in my opinion than radiation, hormonal blockade or chemotherapy. I had already done my homework and knew to watch for hypoglycemia. I limited my dose to 15mg/kg and took benfotiamine to minimize peripheral neuropathy, R+Lipoic Acid for hepatic support, and arranged regular lab work to monitor liver function.
30 days after initiating DCA the pain in my hips and lower spine ceased. One day unremitting pain, the next day none. 60 days after starting DCA the profuse bleeding from bladder and colon ceased completely. My PSA doubling time dropped from 24 days to 72 months and stabilized.
I developed a little numbness in my toes, which was expected. That is reversible over time. As with many cancer drugs, the evil little cells eventually developed resistance to DCA and I resumed androgen blockade for a time before switching to another self-administered novel treatment. Because of DCA I enjoyed ten wonderful, pain-free months during which I traveled, worked outdoors, got a tan, recovered my strength and my spirits. I have no regrets, not one.
This pattern of temporary remission seems to be a typical experience for early adopters of DCA, although there have been a few reports of complete cures (prostate cancer, sarcoma). About 1,700 patients around the world are currently utilizing DCA as a cancer treatment, off-label. The most organized DCA treatment program is offered by the Medicor Clinic in Canada: http://www.medicorcancer.com/dca-reports.html
Reading about DCA on the web one encounters venomous hostility to self-administered novel treatments for cancer, and to the use of DCA in particular; sadly, one such source has been quoted today on /. A more appropriate reference might be this op-ed in the New York Times, "Patents Over Patients" http://www.nytimes.com/2007/04/01/opinion/01moss.html
Whether it is more ethical to allow patients (and their doctors) to utilize an orphan drug off-label, or to tell them they can't utilize a molecule that may extend or even save their lives is a question for another discussion.
Parent is correct: I've got a "retarded" (learning/developmental disorder) child and there's nothing more frustrating than meeting a parent whose kid has a different disability coming out with the equivalent of "at least my kid's not a retard".
The stem cell transplants currently used for leukemias and lymphomas involves completely eradicating the host immune system through chemotherapy and/or radiation therapy. Then a donor stem cell is implanted and is used to replace the host immune system (which will hopefully be completely eradicated and not pumping out cancer cells). Dr Cui's research is a little different. He is keeping the host immune system intact, but is taking sample immune cells from donors with cancer resistance and injecting them into the host. The goal is that the donor cells will kill the cancer but not the rest of the host's cells which leads to GVHD. This seems to work for solid tumours in rats. A good summary of is research is here.
In the US, the usual FDA process for drug approval is to go through 3 phases of human trials (then a mandatory phase 4 during which adverse event data from the wild is gathered and analyzed). There is a Fast Track program at the FDA for serious diseases where there is a need for treatment options. This allows drugs to get approved faster by skipping steps and using surrogate end points instead of proving complete efficacy and safety.
I'd be interested to hear the reasons that grants were not given to continue this research. It might have something to do with there not being a specific mechanism of action identifiable in his experiments. In his interview he admits that he has no idea why it works, but it seems to work. Sciency people don't like things like that. They probably have a better reason than "it seems a little hokey", though.