The DIY Clinical Trial

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[Thanks to duplicity for suggesting this show.]

Chelsea noted in her post for Marcia Angell on Big Pharma last week that we were were thinking about a whole series on our pharmaceutical nation. It actually occurs to me now that tomorrow’s sports doping show might qualify, but this fantastic pitch from our loyal (and not at all duplicitous) listener duplicity certainly does:

I just came across this news item about a group of cancer patients who are putting together a sort of open-source Phase III clinical trial for terminal cancer at thedcasite.com.

Basically there’s a compound that has been shown to reduce human tumors growing in rodents, but no major trial of the drug has been performed in humans — at least partially because there is no money in a potential patent for the drug, which is the way Big Pharm recoups its losses in funding large-scale human clinical trials of experimental drugs. The drug is available online (‘for veterinary use,’ to bypass the FDA), and terminal cancer patients have been ordering it and plan to track their response to the group as a database (should we suggest a wiki?). Scientifically speaking, this would not provide proof of the drug’s effectiveness unless it is properly done (as Dr. Evangelos Michelakis is trying), but such trials are arduous, expensive, heavily regulated and controlled, and necessarily slow.

The bioethical questions surrounding drug development, trials, and approval notwithstanding, an analysis of this situation could provide insight into how and why medical treatment is dominated by large corporations, the role of the internet in and the overall pace of contemporary medicine, access to experimental drugs for terminally ill patients (on which I seem to recall a New York Times Magazine or New Yorker piece on not too long ago), and a whole slew of other questions. It’s clearly life-or-death in some people’s minds, but the question lingers about whether it really works or it’s going to be like a set of other promising anti-cancer drugs that have been disappointing.

duplicity, in a show pitch to Open Source

Duplicity should get an extra scoop of ice cream for this.

I’m putting calls out to the people running this bottom-up, democratized, decentralized clinical trial, as well as Dr. Evangelos Michelakis, who did the original research that’s gotten people so excited. More soon.

Update, 6/21 11:48am

You might be used to public radio stations (and shows!) asking the public for money, but when’s the last time you read a direct appeal from a medical researcher?

This is part of a recent funding update from Dr. Evangelos Michelakis, the Alberta cardiologist who is spearheading DCA research:

We continue to be moved by your sustained interest and support of our efforts. We have been working tirelessly over the past several months to bring this research from the laboratory to the level of a clinical trial. This is a very challenging endeavor since it is not supported by the pharmaceutical industry. The process of bringing a drug from animal research to clinical trial takes a few years. However over the past three months, we have made significant progress towards achieving our goals….

More importantly, we would like to remind you that this work, at least at its early stages, will not be able to be completed without your ongoing support.

Dr. Evangelos Michelakis, in a letter in DCA Research Information

Are citizen-funded research initiatives and patient-run clinical trials the wave of the future — or a brief detour on the way back to Big Pharma’s business as usual?


  • hurley

    Great suggestion, duplicity. This is an inspiring example of human ingenuity and defiance against the odds, and an absolutely desolating commentary on corporate medicine and the state of health care in the US. I’ve spent an awful lot of time — the cliche for once suits — in cancer wards (with family) and a lot of equally desperate time trying to plot a strategy in the sort of three-dimensional chess universe a cancer victim enters upon diagnosis, particularly a cancer victim of modest means. Is the diagnosis correct? What are the options? Is the oncologist offering me the protocol best suited to my particular cancer, or the one he happens to trade in? The pharma he happens to trade in? Why is he so reluctant to answer my questions? Why does he underprescribe the morphine? What actuarial calculation is in play with the insurance company, and why does it refuse to pay for further treatment? And what of the “alternative” therapies? Does shit and shinola really send tumors into remission? Is that a chicken liver you just pulled out of my side? You want me to pay you what?!

    Why not invite Elizabeth Edwards to discuss the subject? And farther down the road you might consider John Le Carré. He wrote a pretty angry novel on Big Pharma.

  • BJ

    In answer to David’s last question citizen-funded research is very much with us now, especially as the NIH support for medical research stagnates. The difference is that the “ask” is usually made by the institution’s development department rather than the researcher. Go to any cancer-research center’s site and you’ll find a “give” button prominently displayed. It will usually lead you to a page explaining that your contribution will support “our compassionate patient care and groundbreaking research.” The groundbreaking research can, in some instances, include clinical trials.

    In the Nature Clinical Practice item that duplicity links to, the writer notes that the structure of DCA can’t be patented, which is true. However, Michelakis does hold a use patent on the molecule, which essentially gives him exclusive rights to develop it for use as an anti-cancer agent. (There’s a link to his patent on thedcasite.org). If the drug showed any indication of becoming a blockbuster in treating human cancer, it seems likely that the major pharmaceutical manufacturers would be in a bidding war to license it from Michelakis. Moreover, academic technology transfer programs, which are becoming increasingly important sources of institutional revenue, are loathe to let go of a promising new agent; When you do the show, you might want to talk to someone from TecEdmonton, the University of Alberta’s tech transfer office, to see why they withdrew their sponsorship from DCA.

    While DCA may be a great new tool in the oncologic armentarium it seems equally likely that it could be this era’s laetrile.

  • enhabit

    bbc on unauthorized drug trials in Nigeria..not a new story but shocking anyway.

    http://news.bbc.co.uk/2/hi/africa/6768799.stm

    we like to think that we’ve come farther than this…shameful doesn’t even begin to describe it…pfizer!

  • hurley

    An angle almost as bleak:

    http://www.nytimes.com/2006/08/13/us/13inmates.html?ex=1182744000&en=2927082924c50bcc&ei=5070

    Google “drug trials in prisons” and you’ll find more than you want to know.

  • W.M. Palmer

    To complexify, if not temper, the enthusiasm, see

    DCA: Cancer Breakthrough or Urban Legend?

    Enthusiasm Outpacing Science in Possible Cancer Therapy Discovery

    OPINION by LEN LICHTENFELD, M.D.

    Feb. 5, 2007 —

    “There is the medical equivalent of a tsunami wave building out there, only we don’t know where this one is going to land . . ..

    In one group of rats where DCA was given after the injected tumors had been allowed to grow, the tumors immediately (in the authors’ words) decreased in size.

    So far, so good.

    But here is where things begin to get a bit dicey.

    These are quotes taken directly from the article. The first is from a summary printed at the bottom of the first page of the report:

    “The ease of delivery, selectivity, and effectiveness make DCA an attractive candidate for proapoptotic cancer therapy which can be rapidly translated into phase II-III clinical trials.”

    In the discussion section of the paper, the authors conclude with the following statement:

    “Our work & offers a tantalizing suggestion that DCA may have selective anticancer efficacy in patients. The very recent report of the first randomized long-term clinical trial of oral DCA in children with congenital lactic acidosis (at doses similar to those used in our in vivo experiments) showing that DCA was well tolerated and safe (Stacpoole et al., 2006) suggests a potentially easy translation of our work to clinical oncology.” (Emphasis mine)

    In other words, the authors are saying that in their opinion these experiments in the lab and rats suggests that DCA may be a simple, effective treatment for cancer and we should move forward with clinical trials based solely on their theory and their results.

    I am not being critical of the authors’ comments, except for describing this as a “potentially easy” process. Nothing in translation from the bench to the bedside is easy.

    This is not the first time such suggestive statements have been made. In fact, these types of comments are not unusual in papers of this type.

    What I am critical of is the lack of discrimination in judgment of other folks — not the researchers — who have picked up on these lines and rapidly circulated the thought that we have a cure for cancer at hand, and that we must stop doing everything else and get this simple, safe and effective treatment to cancer patients immediately.

    . . . .

    The Facts About DCA

    Please try to understand that I am not saying this is a theory that won’t work. It may, and if it does prove valuable, that would be terrific.

    It is just that I have been around a while and have seen this type of hope and hype just a few times too many.

    I have seen cancer patients’ hopes lifted and dashed so often that I can’t help but be cautious and conservative in my thinking.

    Let’s take a look at what we can say.

    First, I did a literature search on PubMed looking for articles with the terms dichloroacetic acid and cancer.

    Although I didn’t have access to all of the articles, one underlying theme stood out: DCA is an organic chemical that causes liver cancer in laboratory mice when put in their drinking water.

    It is not nontoxic. It is a byproduct of another chemical called trichloroethylene (TCE), which has been a source of concern as a cancer-causing agent for some time.

    Here is what the Agency for Toxic Substances and Disease Registry has to say about TCE:

    “HIGHLIGHTS: Trichloroethylene is a colorless liquid which is used as a solvent for cleaning metal parts. Drinking or breathing high levels of trichloroethylene may cause nervous system effects, liver and lung damage, abnormal heartbeat, coma, and possibly death.”

    So before you start going out and adding DCA to your drinking water to prevent cancer, a degree of caution would be very prudent at this point.

    . . . .

    It is indeed a long, difficult road that must be traveled to demonstrate that an exciting new idea actually works in the treatment of cancer.

    So, pardon me if I am a skeptic. As Jessica Rabbit said, “I am just drawn that way.”

    But I am also an optimist, as I have said many times in these pages. I do believe that there are exciting new developments in cancer treatment emerging from laboratories around the world. Maybe DCA is one of them.

    It’s just that I believe in patience, prudence and caution, because my experience has taught me that those are the best guidelines to follow in assessing reports such as the one in Cancer Cell.

    It is way too soon to know whether this is a cancer treatment breakthrough or an urban legend or something in between.”

  • Treat-Cancer.nl
  • http://www.circles-salon.com allison

    It is interesting this question of how to navigate the medical system vis-a-vis doctors/pharmas/insurers. I’m living this nightmare as we speak. I’m clearly not an objective voice on this subject.

    I can say that if someone wanted to do a clinical trial of a closer to natural product than most pharmas create, I would likely volunteer to participate.

    I can also say that the way the system is devised, I am fearful of discussing what it takes for me to navigate my health care. Ironically, as someone who has adhered to a very healthy lifestyle – natural whole foods, no smoking, very little alchoholic consumption, a life of exercise, etc – I must fear the system. I try in every way I can to keep my treatment as low-cost and as whole-health supporting as possible. I end up paying out of pocket for most of my health care, though I’m “fully” insured. You’d think I would be the ideal patient and insurance customer. In our system, the ideal patient/customer is one who doesn’t ask questions and just follows the doctors/insurers orders, regardless of whether they are wise. So, I can absolutely see why a group of patients would take things into their own hands. Particularly when they’ve been abandoned to die.

  • http://www.holfordwatch.info jon_m

    definitely an interesting idea for a show, but it’s worth remembering that the DCAsite and attempts at an ‘open source trial’ have been very controversial. See for example the debate on scienceblogs.com (summarised here – http://scienceblogs.com/insolence/2007/05/clinical_research_on_dichloroacetate_by_1.php).

    To be blunt, it’s quite possible that an ‘open source trial’ of DCA could – in many ways be worse than Big Pharma’s business as usual. Getting people opposed to the ‘open source trial’ of DCA to speak – as well as those supporting and/or profiting from this ‘trial’ – could make for a very interesting debate.

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  • http://www.holfordwatch.info jon_m

    DCASite has been shut down by the FDA, at least for the moment – http://scienceblogs.com/insolence/2007/07/finally_the_fda_acts_on_thedcasitecom.php#more

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  • http://www.kelebeek.net kelebek

    Medical Resource wrote an interesting post today onHere’s a quick excerpt

  • TRKELEBEK
  • joshjoshn

    Here you can find observation data gathered by Canadian Clinic – Medicor Cancer

    Centres durning DCA therapy:

    medicorcancer.com/DCAtherapyData.html

    and here are 4 cases treated with DCA:

    forums.cancer.vc/respiratory-thoracic/158-case-study-1-mesothelioma-new-post.html

    forums.cancer.vc/skin/157-case-study-2-melanoma-brain-metastases-new-post.html

    medicorcancer.com/DCA-CaseStudy3.html

    medicorcancer.com/DCA-CaseStudy4.html

    here’s an lymphoma remission story using DCA B1 vitamine protocol:

    forums.cancer.vc/hematologic-blood/54-ds-lymphoma-story.html

    and here are other remissions:

    forums.cancer.vc/hematologic-blood/62-case-non-hodgkins-lymphoma-apparent-complete-remission.html

    forums.cancer.vc/genitourinary-cancer/48-wim-huppes-prostate-cancer-story.html

    forums.cancer.vc/genitourinary-cancer/55-ps-kidney-cancer-story.html

    forums.cancer.vc/lung-cancer/56-tom-mcghees-nearly-full-remission-non-small-cell-lung-cancer.html

    forums.cancer.vc/lung-cancer/63-lung-cancer-remission-dca.html

    forums.cancer.vc/digestive-gastrointestinal/47-colo-rectal-cancer-story.html

    forums.cancer.vc/digestive-gastrointestinal/57-bills-bile-duct-cancer-story.html

    forums.cancer.vc/digestive-gastrointestinal/81-gastro-intestinal-stromal-tumors-dca.html

    for more info on alternative therapies and dca see forums.cancer.vc and for additional info see puredca.com and cancer.vc