Cheap, 'safe' drug kills most cancers

Nature 446, 474-475 (29 March 2007) | doi:10.1038/446474a; Published online 28 March 2007


Cancer patients opt for unapproved drug
Helen Pearson

Internet trade pre-empts clinical trial.

An experimental cancer drug shrinks tumours in rats with no apparent side effects. The scientists behind the study plan to do a clinical trial in humans, but it could take years to complete. Meanwhile, dying patients begin taking the unapproved drug and collect their results on the web. Both groups desperately want to save lives: but which is the right route to follow?

This scenario has been playing out in recent weeks for a compound called dichloroacetate (DCA). It taps into long-running issues about whether terminally ill patients should be able to get access to drugs that have not yet had formal approval. Researchers fear that those taking the drug could suffer unanticipated side effects; patients argue they don't have the luxury of waiting for clinical trials to find out.

In January this year, Evangelos Michelakis at the University of Alberta in Edmonton, Canada, and his colleagues reported that DCA has seemingly remarkable anticancer properties (S. Bonnet et al. Cancer Cell 11, 37–51; 2007). DCA is a small molecule that blocks an enzyme in mitochondria — the energy-production centres in cells — causing more glucose to be metabolized in the mitochondria rather than by a different pathway in the cytoplasm. The compound has been in clinical trials for years as a treatment for certain mitochondrial diseases, but it has not yet been approved.


E. MICHELAKIS
Reactivating mitochondria seems to trigger cancer cells
to commit suicide.

Mitochondria also control cell suicide, and Michelakis wondered whether cancer cells were suppressing these cellular structures to prevent the cells from dying — and so thought DCA might reactivate them. When his team gave DCA to rats that were growing human lung tumours, the tumours stopped growing within a week, and three months later were half the size of those in untreated animals. Other experimental drugs have had similar effects. But DCA stands out because it seems to leave healthy cells untouched, has been relatively safe in human trials, can be taken by mouth and easily penetrates tissues. "If there were a magic bullet," wrote Newsweek about the discovery, "it might be something like dichloroacetate."

Because DCA has been around for years, its structure can't be patented and Michelakis found that pharmaceutical companies weren't interested in developing the drug. So he is raising money and hopes to start his own small clinical trial within the next few months.

In the meantime Jim Tassano, who owns a pest-control and marketing company in Sonora, California, came across DCA when researching alternative cancer therapies to help his dying ballroom-dance instructor. He wanted something that was effective, safe and that he could lay his hands on: DCA fit the bill. He ordered some from chemical supply companies, teamed up with a chemist friend and they worked out a way to synthesize the compound themselves. "I couldn't walk away from it," Tassano says. "It could do so much good for so many people."

Tassano set up two websites. The first of these (thedcasite.com) hosts information on DCA and a patient chatroom. On the second (buydca.com) Tassano is selling his home-made DCA — labelled for veterinary use, as drugs sold for human use in the United States must have approval from the Food and Drug Administration (FDA). Tassano says he is sure patients are buying the drug to use on themselves, and reckons that a couple of hundred of people from around the world have bought from the site. Many patients taking DCA — acquired from Tassano, chemical companies or other sources — are reporting their progress on thedcasite.com.

Some of these patients plan to set up a database on Tassano's website to collect DCA results in a more organized way. They want people to submit information including the type of cancer they suffer, medical history and the dose they are taking, says Susan Hirasawa in Seattle, Washington, who suffers from late-stage breast cancer and is one of the organizers. The idea is to provide information for others who want to take DCA, she says, but "it's not a real clinical trial".

Michelakis and other researchers are worried by the development. Although DCA seems safe overall, they point to a clinical trial that was stopped early because those taking the drug developed damage to their peripheral nerves (P. Kaufmann et al. Neurology 66, 324–330; 2006). Without a control group, they point out, it will be impossible to tell whether any improvement in the patients' condition is caused by the drug. Patients could also be taking DCA that is not of pharmaceutical grade and might contain harmful impurities.

Michelakis says the patients could end up undermining efforts to do a controlled clinical trial if, for example, some develop harmful side effects and the drug earns a bad reputation. "It's destroying efforts to do this right," he says. "Any way you look at this, it's a negative development." An FDA spokesperson told Nature that the agency is looking into the matter.

The battle between dying patients who want immediate access to unapproved drugs and doctors who urge trials and caution is a perennial one. Some patients argue that they cannot wait for trials and should have the right to take unapproved drugs, regardless of the risks.

But there are arguments against this. An estimated 95% of cancer drugs that enter clinical trials do not get approval, many because they are ineffective or unsafe, so patients risk shortening their life or making their last days more uncomfortable. "They say what do I have to lose? The truth of the matter is, you have the rest of your life to lose," says George Annas, an expert in bioethics at Boston University School of Public Health.

And if patients can access DCA — or other unapproved drugs — there is no incentive for them to enter a clinical trial. So in terms of public health, ethicists argue, more people will be helped if access to unapproved drugs is restricted and proper trials performed.

Peter Jacobsen, an expert in ethics, health and law at the University of Michigan in Ann Arbor, doubts whether any good can come of the patients' efforts. They are so desperate to see results, he says, that there is no way they can report unbiased results and no mechanism to ensure the reports are accurate. "I don't trust the data," he says. "It's hard enough to rely on them in clinical trials, let alone this."

http://www.nature.com/nature/journal/v446/n7135/full/446474a.html


http://www.depmed.ualberta.ca/dca/

http://google2.fda.gov/search?clien...ml_no_dtd&getfields=*&q=dichloroacetate&as=GO

 

I am so conflicted by this.

There is no clinical proof that ingesting DCA in humans can slow or reverse cancer metastasis, although it has apparently been shown to be efficacious in lab rats.

But who among us wouldn't want to try this when all else fails, if we were to be struck by cancer?

 

Its your body, not the FDA's, you should have a right to put whatever you want into it.

 

DCA Research Information
The Official University of Alberta Website



Letter from Dr. Evangelos Michelakis
Department of Medicine, University of Alberta
March 15, 2007

Dear Friends:

Let me first express my heart felt thanks for all of your support. Our entire team has been overwhelmed with your messages of encouragement and hope. We have also heard many stories of heartbreak and loss which serve to accentuate the sense of urgency to find a viable and more humane treatment for cancer. Your support is helping us to move this important work forward.

The research plan for clinical trials, testing DCA as a cancer treatment in human beings, is complex and requires careful planning. We are aware that each day the research is delayed greatly impacts those of you who are living with cancer and those of you caring for someone with cancer. It’s been a mere six weeks since our initial results have been published and we now await approval of our research plan from Health Canada. The approval process will take a number of weeks and possibly months. We will continue to update the website when there are significant developments.

We are optimistic that we will be able to launch the trials within a matter of months, a process that normally takes several years. We are enjoying the support of the University of Alberta Faculty of Medicine & Dentistry and the Alberta Cancer Board, and help from people like you, makes us confident that we will at least succeed in completing this first trial. By itself, taking a drug from the laboratory all the way to completing a clinical trial, is a tremendously difficult process that is almost never completed without the direct support of pharmaceutical industry.

I want to thank all of you who have made contributions to the research fund. We’ve received generous donations, both small and large, from all over the world - from Canada, the USA, China, Holland, Australia, Greece, India, the Philippines and the UK. These funds, almost $100,000, have already helped us secure some of the supplies that we require. However, for the initial research in humans to start, we need to achieve our fundraising goal of $1.5 million. We need this groundswell of support from our global community to grow to insure our success.

On behalf of myself and the Steering Committee for the DCA study, I want to thank you for your caring support and generosity.

Yours truly,

Dr. Evangelos Michelakis




UPDATE March 15, 2007
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. Sebastian 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


--------------------------------------------------------------------------------

UPDATE January 23, 2007 - Investigators at the University of Alberta have recently reported that a drug previously used in humans for the treatment of rare disorders of metabolism is also able to cause tumor regression in a number of human cancers growing in animals. This drug, dichloroacetate (DCA), appears to suppress the growth of cancer cells without affecting normal cells, suggesting that it might not have the dramatic side effects of standard chemotherapies.

At this point, the University of Alberta, the Alberta Cancer Board and Capital Health do not condone or advise the use of dichloroacetate (DCA) in human beings for the treatment of cancer since no human beings have gone through clinical trials using DCA to treat cancer. However, the University of Alberta and the Alberta Cancer Board are committed to performing clinical trials in the immediate future in consultation with regulatory agencies such as Health Canada. We believe that because DCA has been used on human beings in Phase 1 and Phase 2 trials of metabolic diseases, the cancer clinical trials timeline for our research will be much shorter than usual.




http://www.depmed.ualberta.ca/dca/

 

check this out, 50% cure rate of people that had been treated to the max with chemo/radiation/surgery and given up for dead, overseen by the FDA:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6522427&dopt=Abstract

Funny, I never heard of anybody packaging the treatment protocol and selling it....

 

Curing Cancer: A Patent Impossibility
by Bill Walker

DIGG THIS

The good news this month is that a Canadian team under Dr. Michelakis at the University of Ottawa has discovered that a simple, inexpensive chemical is a powerful anticancer agent, effective against a broad range of cancers. (Read their paper in the January Cancer Cell, subscription required). The bad news is that it is a simple, inexpensive chemical long used in medicine, and is not patentable. Thus there is no mechanism for getting the chemical (dichloroacetate, DCA) past the billion-dollar barrier of FDA approval. (The FDA actually only approved 17 drugs last year, and the drug industry spent 40 billion dollars on R&D).

Scientists have known since 1930 that cancer cells use glycolysis instead of aerobic respiration for energy. In other words, they don’t turn on their mitochondria and burn their glucose with oxygen, as do normal cells; they just convert it to lactic acid. While glycolysis provides about fifteen times less energy per blood sugar molecule, it works under the oxygen-deprived conditions inside early tumors. It also has the advantage of bypassing the mitochondria entirely, which allows the cancer cells to suppress the cell’s self-destruct mechanisms.

DCA forces the cell to turn on its mitochondria. This was the primary medical use of DCA in the past, to treat patients with rare metabolic deficiencies. For a normal cell, being "forced" to turn on mitochondria isn’t such a big deal… they’re already on.

But for a cancer cell, the mitochondria are time bombs. When the cancer’s mitochondria turn on, they run out of control, creating high hydrogen peroxide levels inside the mitochondria. This leads to a cascade of chemical reactions that eventually activates two different self-destruct ("apoptosis") pathways in the cell.

The ability to reactivate self-destruction is one of the "holy grails" of cancer research. There are other approaches to induce apoptosis in cancer cells, and perhaps some of them would actually work if they were combined with DCA. Also, even if it is eventually found that cancer can mutate and develop DCA resistance, the long period of regression could allow newer but slow anticancer concepts (such as telomerase inhibition) to finish off the remaining cancer cells.

So far Dr. Michelakis has demonstrated the effectiveness of DCA against various human cancer cell lines in a cell culture, and against human tumors growing on immune-suppressed rats. The drug has already been tested on human beings for many years as a treatment for a genetic enzyme deficiency. There are millions of terminal cancer victims on this planet. So, logically, the next step would be to find some volunteers and start trying to find the optimum human dose range, combinations of other apoptosis inducers that work synergistically with DCA, supplements to reduce side effects, etc.

Logically in our libertarian minds, perhaps. In the real world, nothing of the kind will happen. The FDA will not allow people in the orderly and profitable process of agonizing death by incurable cancers to try nonapproved drugs. No drug company, no matter how large, can afford to spend a billion dollars and 19 years getting a nonpatentable treatment through the bureaucratic minefield. There is no FDA-approved way to get there from here.

Someday a dedicated medical team working beyond the reach of the FDA (perhaps in Mainland China, which already contains numerous clinics that cater to foreign medical refugees) will defeat cancer1. In the intervening years or decades, terminal cancer patients in the US will be restricted to the same old patent medicines.

Note

If you’re a dedicated medical team working beyond the reach of the FDA, the rats in the study were given the same dose of DCA as human patients with enzyme disorders, 50–100 milligrams of drug per kilogram of body weight, dissolved in their water.
January 22, 2007

Bill Walker [send him mail] works in HIV and gene therapy research in Rochester, Minnesota.

Copyright © 2007 LewRockwell.com

Bill Walker: Archives

 

Funny,

All you need is keep an alkaline pH and the cancer cells subside because they can only exist in an acidic environment.

Simple prevention, even a cure.

Instead, let's search for drugs.

 

Where's the hundreds of billions of profits in that?

We believe in spending hundreds of billions of dollars to cure disease in this country, rather than a few measly million to prevent them.

Big pharma developed pills that they sell for around 35 billion per year (cumulatively) to drop cholesterol levels a few points (and that cause adverse side effects), when dietary changes and exercise would do far more at no cost (and have positive side effects).

And the government is the biggest purchaser of these drugs with your and my tax dollars.

Damnit.

 

Why does this guy need donations for his research?
If this had merit I would think the government would be throwing money at him.

Smells fishy....Althought it would be great if it were true.

AAA30

 

It seems reasonable that govt would provide money for trials .... but:

- how long does it take to get that money?
- who influences the decisions?

I would have thought that Bill was the guy to approach about this.

A lot of things that were not trialled previously have been tested recently (garlic for example) but its typically on a small scale (not full clinical trials) and the trials came a long long time after the claims to efficacy.