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Comment Why has the FDA not approved any drugs like...DCA? (Score 1) 223

"MMS, B17 and DCA are all unpatentable. The FDA drug approval process is patent-based. Without a full patent and full ownership no pharmaceutical company will invest in drug development as they do not own the rights to the drug. The costs of drug testing are very high, with figures running from several hundred million to over a billion dollars. The FDA expects drug companies to have patent protection to allow them the ability to recover the high drug research and testing costs. Even orphan drugs need patent protection and the FDA often goes one step further by granting marketing exclusivity to compensate for the smaller markets those drugs serve.

There is no system in place for the development of unpatentable drugs, materials currently in the public domain. These potential therapies do not qualify as generic drugs either, as generics were patented drugs for which the research data has been submitted and the patents have expired. No data is in place for drugs that are not patentable."

http://answers.yahoo.com/question/index?qid=20100809202210AA7A6h9

While it doesn't cover unpatentable drugs, the purpose of the Orphan Drug Act is an attempt to add incentive where Big Pharma can't find any on their own to develop drugs for less well covered diseases. It is a recognition by the government that without patents, drug companies and the universities they partner with are less willing to pursue research where there is no money to be made by a temporary monopoly on the drugs resulting from the research.
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C0CE4DF1F3EF933A05757C0A966958260
http://en.wikipedia.org/wiki/Orphan_drug

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Comment DCA may be like Alexander cutting the Gordian Knot (Score 1) 223

Agreed, chemo works except when it doesn't.

It looks like UCLA is now paying attention and starting their own trial for using DCA on recurring breast cancer (breast cancer that was once treated, but has returned even after chemo).

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01029925

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Comment The University of Alberta Discovery (Score 1) 223

"...it may soon be used as an effective treatment for many forms of cancer."

http://www.dca.med.ualberta.ca/Home/Updates/2007-03-15_Update.cfm

"The University of Alberta Discovery

DCA is an odourless, colourless, inexpensive, relatively non-toxic, small molecule. And researchers at the University of Alberta believe it may soon be used as an effective treatment for many forms of cancer.

Dr. Evangelos Michelakis, a professor at the U of A Department of Medicine, has shown that dichloroacetate (DCA) causes regression in several cancers, including lung, breast, and brain tumors.

Michelakis and his colleagues, including post-doctoral fellow Dr. Sebastien Bonnet, have published the results of their research in the journal Cancer Cell.

Scientists and doctors have used DCA for decades to treat children with inborn errors of metabolism due to mitochondrial diseases. Mitochondria, the energy producing units in cells, have been connected with cancer since the 1930s, when researchers first noticed that these organelles dysfunction when cancer is present.

Until recently, researchers believed that cancer-affected mitochondria are permanently damaged and that this damage is the result, not the cause, of the cancer. But Michelakis, a cardiologist, questioned this belief and began testing DCA, which activates a critical mitochondrial enzyme, as a way to "revive" cancer-affected mitochondria.

The results astounded him.

Michelakis and his colleagues found that DCA normalized the mitochondrial function in many cancers, showing that their function was actively suppressed by the cancer but was not permanently damaged by it.

More importantly, they found that the normalization of mitochondrial function resulted in a significant decrease in tumor growth both in test tubes and in animal models. Also, they noted that DCA, unlike most currently used chemotherapies, did not have any effects on normal, non-cancerous tissues.

"I think DCA can be selective for cancer because it attacks a fundamental process in cancer development that is unique to cancer cells," Michelakis said. "One of the really exciting things about this compound is that it might be able to treat many different forms of cancer".

Another encouraging thing about DCA is that, being so small, it is easily absorbed in the body, and, after oral intake, it can reach areas in the body that other drugs cannot, making it possible to treat brain cancers, for example.

Also, because DCA has been used in both healthy people and sick patients with mitochondrial diseases, researchers already know that it is a relatively non-toxic molecule that can be immediately tested patients with cancer.

        "The results are intriguing because they point to the critical role that mitochondria play: they impart a unique trait to cancer cells that can be exploited for cancer therapy"
        Dario Alteri
        Director University of Massachusetts Cancer Center

Investing in Research

The DCA compound is not patented and not owned by any pharmaceutical company, and, therefore, would likely be an inexpensive drug to administer, says Michelakis, the Canada Research Chair in Pulmonary Hypertension and Director of the Pulmonary Hypertension Program with Capital Health, one of Canada's largest health authorities.

However, as DCA is not patented, Michelakis is concerned that it may be difficult to find funding from private investors to test DCA in clinical trials. He is grateful for the support he has already received from publicly funded agencies, such as the Canadian Institutes for Health Research (CIHR), and he is hopeful such support will continue and allow him to conduct clinical trials of DCA on cancer patients.

Michelakis' research is currently funded by the CIHR, the Canada Foundation for Innovation, the Canada Research Chairs program, and the Alberta Heritage Foundation for Medical Research.

"This preliminary research is encouraging and offers hope to thousands of Canadians and all others around the world who are afflicted by cancer, as it accelerates our understanding of and action around targeted cancer treatments," said Dr. Philip Branton, Scientific Director of the CIHR Institute of Cancer.

DCA and Cancer Patients

The University of Alberta's DCA Research Team is set to launch clinical trials on humans in the spring of 2007 pending government approval. Knowing that thousands of cancer patients die weekly while waiting for a cure, Dr. Michelakis and his team are working at accelerated speed, condensing research that usually takes years into months. Fundraisers at the University of Alberta are determined to raise the money to allow this next phase of research to begin. Once Health Canada grants formal approval, the University of Alberta's Research Team will begin testing DCA on patients living with cancer. Results with regards to the safety and efficacy of treatment should be known late this year.

        "If there were a magic bullet, though, it might be something like dichloroacetate, or DCA..."
        Newsweek, January 23, 2007 "

A separate trial has started as UCLA...
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01029925

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Comment UCLA now using DCA in cancer trials(Gordian Knot?) (Score 1) 223

Comment Re:DCA - Dichloroacetate (NOT Dichloroacetic acid) (Score 1) 223

I don't mind negative comments, it's part of the layman peer-review process. If the information is worthwhile on Slashdot, it'll usually pick up a mix of knee-jerk negative reactions, knee-jerk positive reactions, a few funny comments (which I enjoy the most), and some thoughtful opinions after some reflection (that we can then learn from).

"It seems that DCA may be promising, although you probably should have included links to more objective websites. The study appears to be legitimate research, but a human trial of only five patients is hardly conclusive. I'm going to pass this information on and hope it isn't all nonsense."

That was the purpose of the post, to give an additional option most haven't heard of yet appears incredibly promising. I wish your friend the best of luck.

If you want more information about the trial, here it is...

http://www.redorbit.com/news/health/1865024/dca_research_on_brain_cancer/
http://www.nature.com/news/2010/100512/full/news.2010.236.html?s=news_rss

It looks like UCLA is now paying attention and starting their own trial for using DCA on recurring breast cancer (breast cancer that was once treated, but has returned).

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01029925

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Comment Re:DCA - Dichloroacetate (NOT Dichloroacetic acid) (Score 1) 223

Patents Over Patients
http://www.nytimes.com/2007/04/01/opinion/01moss.html?_r=1

Patents Over Patients
By RALPH W. MOSS

State College, Pa.

WE could make faster progress against cancer by changing the way drugs are developed. In the current system, if a promising compound can’t be patented, it is highly unlikely ever to make it to market — no matter how well it performs in the laboratory. The development of new cancer drugs is crippled as a result.

The reason for this problem is that bringing a new drug to market is extremely expensive. In 2001, the estimated cost was $802 million; today it is approximately $1 billion. To ensure a healthy return on such staggering investments, drug companies seek to formulate new drugs in a way that guarantees watertight patents. In the meantime, cancer patients miss out on treatments that may be highly effective and less expensive to boot.

In 2004, Johns Hopkins researchers discovered that an off-the-shelf compound called 3-bromopyruvate could arrest the growth of liver cancer in rats. The results were dramatic; moreover, the investigators estimated that the cost to treat patients would be around 70 cents per day. Yet, three years later, no major drug company has shown interest in developing this drug for human use.

Early this year, another readily available industrial chemical, dichloroacetate, was found by researchers at the University of Alberta to shrink tumors in laboratory animals by up to 75 percent. However, as a university news release explained, dichloroacetate is not patentable, and the lead researcher is concerned that it may be difficult to find funding from private investors to test the chemical. So the university is soliciting public donations to finance a clinical trial.

The hormone melatonin, sold as an inexpensive food supplement in the United States, has repeatedly been shown to slow the growth of various cancers when used in conjunction with conventional treatments. Paolo Lissoni, an Italian oncologist, helped write more than 100 articles about this hormone and conducted numerous clinical trials. But when I visited him at his hospital in Monza in 2003, he was in deep despair over the pharmaceutical industry’s total lack of interest in his treatment approach. He has published nothing on the topic since then.

Potential anticancer drugs should be judged on their scientific merit, not on their patentability. One solution might be for the government to enlarge the Food and Drug Administration’s “orphan drug” program, which subsidizes the development of drugs for rare diseases. The definition of orphan drug could be expanded to include unpatentable agents that are scorned as unprofitable by pharmaceutical companies.

We need to foster a research and development environment in which anticancer activity is the main criterion for new drug development.

Ralph W. Moss writes a weekly online newsletter about cancer.

More references here...
http://www.thedcasite.com/Unpatentable_drugs_and_the_FDA.html

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Comment Re:DCA - Dichloroacetate (NOT Dichloroacetic acid) (Score 2) 223

The DCA Site website was put up by laymen to pool together scarce information due to the lack of knowledge available at the time what research was available from corporate or academic sources.

You'll find similar inaccuracies in exact terminology or phrasing in the laymen comments on The DCA Site as you can find in laymen comments in Slashdot. I doubt that the intent was to convey that the mitochondria was completely disabled, only that an important function of the mitochondria, the ability to signal time for cell death, was disabled in cancer cells. Also, the poster was not conveying an opinion, he is citing a paper so that you can look into it further.

http://www.cell.com/cancer-cell/abstract/S1535-6108(06)00372-2

Here's an excerpt from WIki:

"Cancer cells generally use glycolysis rather than respiration (oxidative phosphorylation) for energy (the Warburg effect), as a result of hypoxia that exists in tumors and damaged mitochondria.[13] Usually dangerously damaged cells kill themselves via apoptosis, a mechanism of self-destruction that involves mitochondria, but this mechanism fails in cancer cells.

A phase one study published in January 2007 by researchers at the University of Alberta, who had tested DCA on cancer cells grown in mice, found that DCA restored mitochondrial function, thus restoring apoptosis, killing cancer cells and shrinking the tumors.[14]"

http://en.wikipedia.org/wiki/Dichloroacetic_acid

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Comment DCA - Dichloroacetate (NOT Dichloroacetic acid) (Score 1, Informative) 223

Dichloroacetate (DCA) is a cheap, un-patentable, drug (essentially 1vinegar molecule+2chlorine atoms) currently used to treat a rare enzyme disorder in children, but researchers have found it useful in allowing cancer cells to learn how to kill themselves with reasonably acceptable temporary side effects. See "DCA and How It Works" below.

There is almost no funding for this drug study due to it being un-patentable despite quite encouraging results, and reasonably acceptable and reversible side-effects.

Recent human trial reported here:
http://www.medindia.net/news/Dichloroacetate-Effective-Against-Aggressive-Brain-Cancer-68867-1.htm

Initial news from a couple of years ago...

http://www.dca.med.ualberta.ca/Home/index.cfm
http://www.newscientist.com/channel/health/mg19325874.700-cheap-safe-drug-kills-most-cancers.html?DCMP=ILC-Top5&nsref=mg19325874.700

Here's an excerpt...
"DCA and How It Works
Dichloroacetic acid versus Sodium Dichloroacetate

Dichloroacetic acid is a small molecule, basically acetic acid with 2 chlorines. The molecular formula is Cl2CHCOOH.

Dichloroacetate is the sodium salt of dichloroacetic acid. Replace a hydrogen with sodium and you get Cl2CHCOONa

If you view the video from CTV you will see a jar of dichloroacetic acid prominently displayed. http://www.depmed.ualberta.ca/dca/vid1.htm is well worth watching. But they used a “cheap ...powder”. Dichloroacetic acid only comes in liquid. The powder is the sodium salt of dichloroacetic acid. It is sodium dichloroacetate. The researchers did not use the acid.

For those of you searching for DCA, do not buy the acid. I posted info on the FAQ about it. The acid is not the same thing as the acetate. The acid is dangerously corrosive.

How does DCA work, briefly?

The Michelakis team reports that DCA turns on the mitochondria of cancer cells, allowing them to commit cellular suicide, or apoptosis.

Cancer cells shut down the mitochondria, which is the part of the cell that is involved in metabolism and, incidentally, initiates the cell suicide.

A non-cancerous cell will initiate apoptosis when it detects damage within itself that it cannot repair. But a cancer cell resists the suicide process. That is why chemotherapy and radiation treatments do not work very well and actually result in terrible side effects the healthy cells actually die much easier.

Michelakis and his team discovered that they could re-activate the mitochondria of cancer cells. Not only that, the DCA is very effective in doing it: To quote from the Michelakis paper: “The decrease in [Ca2+]i occurs within 5 min and is sustained after 48 hr of DCA exposure.” The mitochondria are so sensitive to DCA that just 5 minutes of exposure reactivates them for 48 hours.

The metabolic approach to cancer is supported by other research. Inhibition of Glycolysis in Cancer Cells: A Novel Strategy to Overcome Drug Resistance Associated with Mitochondrial Respiratory Defect and Hypoxia is a paper by a John Hopkins research team supporting this approach.

http://www.thedcasite.com/dcaforum/DCForumID1/79.html is a post on our chat room by Willis. giving a prediction as to which cancers DCA might not control, and it is being supported by the reports we are receiving."

More on the left side of this web page:
http://www.thedcasite.com/dca_how_it_works.html

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