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DCA – The Plot Sickens

About a year ago the chemical compound dichloroacetate was in the news as a potential miracle cure for cancer shortly after a scientist at the University of Edmonton published experimental results showing human cancers melting off of lab rats in a matter of a few weeks with virtually no adverse side effects. As it turned out the Edmonton scientist had kept his experiments confidential for two years while he filed patents and tried to find a pharmaceutical company to fund clinical trials. The fly in the ointment is that dichloroacetate (DCA) has been around a long time and used in the treatment of a rare mitochondrial genetic disorder. The drug itself isn’t patentable but technically the therapeutic procedure to treat cancer with it can be patented but those patents are weak and drug companies won’t rely on them to protect their investment in a hundred million dollar clinical trial. No pharmaceutical companies were willing to fund the trials, no one else can afford the trials, so whatever the potential is for cancer treatment in humans remains unknown and there is no progress being made to find out.

Then a guy in California heard about it and collaborated with a cancer drug chemist at the University of California to develop a manufacturing process for cheap pharmaceutical grade DCA. After getting the process worked out and the drug being produced and marketed for experimental use in animals (which is legal) the FDA quickly stepped in and shut it down saying the animal use disclaimer was no more than a thinly veiled way to make it available for people with cancer to self-medicate. That was true enough – the animal use disclaimer was a ruse. The shutdown was about 6 months ago. The drug was available for people to try for about 3 months. A number of them tried and recorded their results on a blog provided by the DCA manufacturer. The cost of a month’s supply of the drug was about $50. The results people obtained were mixed and due to the anecdotal nature and small number of uncoordinated informal trials were unreliable.

Now a news story just came out about yet another university scientist who discovered DCA’s potential to treat cancer at around the same time the Edmonton scientist was running his experiments. This university filed 25 patents and also was unsuccessful in finding a pharmaceutical company willing to invest in clinical trials. So the potential miracle cure for cancer that costs next to nothing and has virtually no side effects compared to other cancer chemo-therapies remains an untested potential years after its discovery and it appears as if it will remain untested forever all because no one can figure out a way to make a profit from it. Isn’t that just precious.

CU cancels agreement with pharmaceutical company
By WAYNE HEILMAN
THE GAZETTE
January 7, 2008 – 11:02PM

The University of Colorado has canceled an agreement with Agada Pharmaceuticals Inc. to license chemical compounds developed by a faculty member to treat cancer.

Denver-based Agada, previously known as Newellink Inc., violated the 2003 agreement by “failing to meet its obligations,” prompting the university to end the agreement in October, said David Allen, the university’s associate vice president for technology transfer.

As a result of the cancellation, rights to the compounds developed by Karen Newell, a University of Colorado at Colorado Springs associate biology professor, go back to the university, which is in “discussions” with three or four potential licensees, Allen said.

“We believe that this is very (marketable) technology,” said Allen, who hopes to sign a new license agreement for the technology this year.

Newell’s research at UCCS and University of Vermont found that the chemical compound dichloroacetate robs cancerous tumors of energy they need to grow.

The university has 25 patents awarded or in various stages of approval covering the compound and its use to treat cancer.

As a result of the cancellation, Newell said Agada has shut down. She started the company in 2002 to turn her research into marketable products but never got the compound into clinical trials despite $2.1 million in investments from a California family.

Newell last year sought out David Drake, who had headed Fitzsimmons BioBusiness Incubator in Aurora, to rescue the company from near failure, but she said he wasn’t able to raise the money needed to make license payments to the university or begin clinical trials.

Click here to read all the past articles I’ve written as this DCA saga unfolded…

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26 Responses to DCA – The Plot Sickens

  1. “So the potential miracle cure for cancer… will remain untested forever all because no one can figure out a way to make a profit from it.”

    But huge profits can be made from drugs that are not patented! Nicotine and caffeine come to mind…

  2. Folgers and William Morris refused too. The tobacco company representative is rumored to have said “DCA is not addictive and neither is nicotine but the unfortunate situation is that DCA doesn’t have that great tobacco flavor and pure smoking pleasure that people love so much.” The coffee company rep said DCA was too easy to make. “It’s like table salt. You don’t need Juan Valdez putting his heart and soul into growing and harvesting salt beans at the peak of perfection. DCA tastes like crap too.”

  3. Incredible!!

  4. helpful websites
    http://www.newscientist.com/article.ns?id=dn10971
    and it also links to this
    http://www.depmed.ualberta.ca/dca/
    which offers an opportunity to donate to a research fund.

  5. Taxpayers in California put themselves on the hook for billions to fund embryonic stem cell research. I don’t know if anything useful has come of it, but apparently someone had decided that, like DCA, the project didn’t make business sense, so someone had to be found to give them the money.

    And I wonder why DCA isn’t available in other countries without strict drug enforcement? A Canadian relative of mine used to drive to Mexico every year for medications that weren’t approved in North America.

  6. the problem as I see it is not about availability but rather the funding for real human trials.

  7. There are two other entities who have huge financial interests in cancer treatments besides pharmaceutical companies. These are private insurance companies and government medicare. They are shelling out tens of billions of dollars a year for drugs in chemotherapy treatments. If they could cut their costs they would seem to want this drug on the market if it were effective.

    My guess is a typical surgery, radiation and chemo treatment is in the multi hundred thousand dollar cost range. At this moment I have a very close family member going through the process and if such a miracle drug existed it would be highly desirable. Neither surgery, radiation or chemo are nice treatments though I understand all have improved dramatically in recent years.

    An aside: I saw an article a few months ago where German researchers are working on starving cancer cells by a low carbohydrate diet. I cannot find the article but apparently others are working on ways to get at treating cancer by focusing on cancers cells only using anaerobic metabolism. If there are no carbohydrates then there is no fuel for glycolytic anaerobic metabolism but I don’t know the dangers to the rest of the body with such drastic carbohydrate restrictions.

  8. Jerry, here it is:

    http://www.time.com/time/healt.....84,00.html

    I wonder if there’s some kind of low-carb beer involved?

  9. I can’t say I see any real villains here — if it really costs a hundred million dollars to verify whether a proposed drug is effective and without severe offsetting side-effects, and if we want our government to ban drugs that are ineffective and that have severe offsetting side-effects, then we are only going to get drugs that are profitable even with a sunk cost of a hundred million dollars, unless people decide simply to spend the hundred million and risk the possibility that the drug fails the test and the hundred million is wasted. You can’t blame the companies — they’re responsible for their investors’ money and if the patents really aren’t strong enough to protect the investment, you can’t expect them to make a hundred million dollar gift of their investors’ money.

    Instead you have to make the case to the public at large, either to raise the hundred million through charitable donations, or to get the law changed — either by appropriating a hundred million taxpayer dollars so that the people pay for the test, or by strengthening the patent laws for this drug so that the test now becomes a sound risk for the companies to take.

    I know that an option for terminal or near-terminal patients is to permit them to take drugs that have not undergone the hundred-million-dollar-test, but waiving the test for a certain class of patients is a separate kind of issue — it goes to the policy of how the government should police and regulate the availability of proposed drugs, rather than the question of who should bear the cost and risk of testing them.

  10. Russ,

    Mucho Thanks for the link.

    If a low carb beer is effective then the Germans will find out.

  11. 100 million dollars to test a drug? No wonder drugs cost so much.

  12. Sisson has a point and that is where the gov’t should step in. That is the gov’t should fund the research.

    The notion that someone won’t fund something unless there is a profit has to stop. Heck these people who do the funding have enough money that if they just break even they will still have more than they can spend.

  13. Sisson. “we want our government to ban drugs that are ineffective and that have severe offsetting side-effects”

    Do we? I tend to be libertarian on this. So long as there is full disclosure, should I not have to choice to go to a doctor who has no medical license or a lawyer who never passed the bar? Doctors and lawyers who gain greater credentials would certainly command a premium in the market, but if patient A or client B want to take a risk on a cheaper alternative, as long as they know what they are doing, why should the government say they cannot. We let people buy BMW’s and we let them buy Yugos (one wonders if any are still running). So long as the person buying the Yugo is not tricked into thinking he’s buying a BMW, no one sees a problem with this.

    As for drugs, if I want to take an extreme risk on a new drug, so long as I know I am taking an extreme risk, why should the government forbid me?

    When I was in the Colorado legislature many (if not most) of the bills we dealt with were business people seeking to impose government restrictions on their own industry or to hamper their competitors. Economists call this “rent seeking.” As you might guess, I was always a “no” vote on more “we’re from the government and we’re here to help you” bills.

  14. “So long as there is full disclosure, should I not have the choice to go to a doctor who has no medical license or a lawyer who never passed the bar?”

    Hear, hear! Yes, you (and I and everyone else) should have that choice.

  15. Every time I read about this I can’t help thinking, “Something is rotten in America”. People with power and money (these days the 2 are about equivalent) – the more you have the latter the more you have the former – who don’t give a damn about anything or anyone but themselves.
    Pharmaceutical companies are monsters. It has nothing to do with altruism – it’s all purely profit – “and nothing else matters”.

    And this is the consequence of materialism.

    Bill Gates could fund the whole thing and never miss a cent. I’d bet he would if he had cancer himself.
    So could a lot of other multi-billionaires.

    Simplistic? Sure. Exactly what we need. Simple and effective.
    It’s gotten so ruddy complicated and thus so ridiculously, even hilariously, expensive to do anything in medicine these days that many pay with their lives for the selfishness of others. And government is just as guilty as the others. Just read “Cancer Gate” by Samuel S. Epstein, M.D. – who also wrote “The Politics of Cancer” (1978).

    The whole “plot” (as per the thread’s title) is utterly sickening. There should be a major public outcry.

  16. BarryA and Gerry Rzeppa.

    If we had a Constitutional government, you would have the choices you wish you had. Unfortunately, today, the US Constitution is as respected as toilet paper by the government and the governing class.

    There is one Presidential candidate who wants to rectify this… Unfortunately he’s just not taken seriously enough by enough people…

  17. jerry

    They are shelling out tens of billions of dollars a year for drugs in chemotherapy treatments.

    Private insurers make a profit doing it. Money is earned via percentage of the cash flow. The more cash that flows the better. Government is a different story as it’s not the same for-profit structure as private enterprise. They’re in it for the bureaucracy (gov’t jobs) but again cash-flow is the name of the game. The more money flowing through gov’t adminstration the more gov’t adminstrators are justified to manage it all.

  18. sisson

    I know that an option for terminal or near-terminal patients is to permit them to take drugs that have not undergone the hundred-million-dollar-test, but waiving the test for a certain class of patients is a separate kind of issue

    Absolutely false. You can be knocking on death’s door and you still can’t legally self-medicate with unapproved controlled substances. DCA wasn’t a controlled substance a year ago but as soon as the FDA got wind of people using it as an anti-cancer drug they effectively made it a controlled substance so no one could buy it any longer. That’s the most frustrating thing about this. People in stage 4 cancer who have run out of approved treatment options are simply told to tidy up their affairs and die. These people have nothing to lose and everything to gain by taking DCA yet they cannot even try to save their own lives after the medical establishment has given up on them.

  19. geoff

    Not just $100M but $100M and around 10 years of time.

    DCA could be fast tracked as it’s already gone through phase 1 clinical trials to treat a childhood genetic disorder called lactic acidosis. DCA is extremely non-toxic in cancer therapeutic doses. Children were given very high doses continually for years to treat lactic acidosis. The dosage rate for cancer treatment is much lower and lasts weeks to months not years. The cost to complete phase 2 clinical trials and get the drug onto the mass market is still in the 8 figure range but could probably be done in 5 years. The whole problem remains that DCA is a common, inexpensive byproduct of several industrial processes. It’s even found in chlorinated tap water as a byproduct of chlorination. It can’t be patented and manufacturing cost is essentially nil. There’s nothing to be gained by anyone making or selling DCA. The only people who stand to benefit from it are people who have cancer. If it was a patentable drug it would probably be on the market within a year as it would have been fast tracked into a phase 2 trial several years ago.

  20. One still has to ask why nobody in the whole world is really working on this.

  21. It is important for all discussants to realize that the story on DCA is not all that clear. It is mutagenic and causes liver and kidney tumors. See:
    http://www.pubmedcentral.nih.g.....d=16966105

  22. I can’t find the University of Edmonton website. Does this place really exist? Or can Canadian universities not afford websites?

  23. University of Edmonton, Alberta
    http://www.ualberta.ca/
    I already gave this link
    http://www.depmed.ualberta.ca/dca/

  24. oh I see this “DCA Update: Health Canada Approves First DCA Clinical Trial in Cancer”
    So we’ll see if DCA is for real or not. Isn’t that what real science is supposed to be about?

  25. anton

    Lots of things are carcinogens over long periods of time and exceptionally high dosages.

    Commonly employed cancer chemical and radiation therapies are near deadly in the short term. Surgical intervention often carries a very high risk as well. They are prescribed and monitored quite closely for how much the patient can tolerate so the medical intervention doesn’t kill him before the cancer does.

    That said, DCA is almost zero risk in comparison. It’s about as toxic as aspirin. Yes, if you subject a lab rat to high doses of DCA over many months or years it induces liver cancer and peripheral neuropathy. Aspirin will cause considerable damage if taken in large doses and/or over long periods of time as well.

    DCA as a cancer therapeutic is taken in moderate doses over a course of weeks. Much less for a much shorter period of time than when it is prescribed for lactic acidosis.

    The frustrating point is that someone who’s told they have six months to live and there’s nothing more medicine can do to save their life is prohibited from self-medicating with DCA. Is the prospect of some nerve damage or liver cancer if it is taken in high doses for two years a reasonable excuse for prohibition? Someone with six months left to live isn’t worrying about what DCA might do to him in two years. He’d be thankful if he lived long enough to find out. Find another excuse. That one doesn’t hold water.

  26. It is long-established standard operating procedure in medical science for successful animal experiments to be followed by clinical trials. That’s how new discoveries in the field are made. So one has to ask, what possible reason could the FDA have, in this case and others, for standing in the way of medical progress? Is it merely that they are in the pockets of the drug companies?

    Realize that the Boomer Generation has voted itself TRILLIONS in unfunded mandates for its old age — primary among them being Medicare and Social Security — mandates that may well end up bankrupting not just the government, but just about everyone else too. Hence, within the government and other bureaucracies, the apparatchiks are being presented with fewer and fewer incentives to promote a healthier and longer-lived America, and more and more incentives to bump off as many Boomers as possible (inadvertently, of course, and with only the best motives in mind) as quickly as possible.

    That, IMHCO, is what the push for making people wait in line for treatment in a nationalized “healthcare” system is all about. Bumping off Boomers. (Which, don’t get me wrong. In my estimation it couldn’t happen to a nicer generation.)

    It’s not in vain that the books of Daniel and Revelation depict governmental systems (a.k.a. “nations”) as “beasts.” Looked at holistically, such systems display as much of a survival instinct as any individual organism. So if the survival of the present system means driving medical science back into the Dark Ages, so be it.

    Go ahead. Color me paranoid, call me a crank, and think happy thoughts! But for the good of your country and for the sake of your children and grandchildren, please, DIE, DIE, DIE!

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