Bioethics Cancer Clinical trials Medicine Quackery Skepticism/critical thinking

“Clinical research” on dichloroacetate by A travesty of science

I hadn’t planned on revisiting this topic again quite so soon, but sometimes a piece of information comes up that’s so disturbing that I can’t ignore it and can’t justify delaying blogging about it by very long. So it is yet again with the strange and disturbing saga of dichloroacetate (DCA), the small molecular chemotherapeutic drug with a novel and scientifically interesting mechanism of action that could lead to a whole new class of chemotherapeutic agents and that has shown considerable promise in rat tumor models but has not yet been tested in humans. Not to belabor the story, which has been told in many of the posts listed in the links at the end of this article, because of the mystique of a seemingly effective drug (in animal tumor models, at least) with a new mechanism of activity that is inexpensive to produce and that “big pharma” either shows little interest in or (as has been claimed) has tried to “suppress,” a black market for home brew DCA has popped up, fueled by Internet “entrepreneur” Jim Tassano, a pesticide dealer who decided to hire a chemist and start making and selling home made DCA to desperate cancer patients over the Internet at

I’ve made my position abundantly clear about what I think about Jim Tassano, his unscrupulous targeting of desperate cancer patients, and his contribution to a culture among the regulars on The DCA Site discussion forums in which wishful thinking and claims of success when objective examination of the cases indicates that no success or very questionable success is the order of the day, regardless of tumor biology. One of my biggest complaints about this whole enterprise, besides the sheer exploitation of dying cancer patients, is that this whole enterprise is unlikely to provide much, if any useful information about whether or not DCA has efficacy against cancer and, worse, that it taints a very promising drug with a whiff of quackery, which may make people less willing to support clinical trials on a promising new drug that may be the prototype for an entire new class of anticancer drugs. After all, if there doesn’t seem to be any efficacy in all the anecdotes popping up on, as I have documented, then enthusiasm for the drug may wane–particularly if a self-experimenter dies or suffers serious harm as a result of DCA. In the meantime, patients tumors are still growing and cancer patients are still dying despite their taking DCA, and it is unclear whether any of them are foregoing effective palliative care in their zeal to try DCA.

Apparently Jim Tassano is aware of the criticism that the wild experimentation he’s promoting isn’t a clinical trial and is highly unlikely to result in any useful information that will tell us whether DCA is effective against cancer, unless there are dramatic and undeniable responses to DCA that can be detected even by amateurs. I say this because little birdie happened to forward to me this message from Jim Tassano sent to people on his mailing list.

As a translational and clinical researcher, I’m appalled.

If you thought Jim Tassano was unethical for selling home brew DCA to desperate cancer patients, you ain’t seen nothin’ yet. This e-mail appears to be an attempt by Tassano to address the complaint that no useful information will come from his sales of DCA. Before I look at it in more detail, some introductory observations are in order. Make no mistake about it, this is an attempt at clinical research. It’s a piss-poor amateurish attempt, but it’s an attempt. It’s also totally unethical, and here’s why, leaving out the deficiencies of the questionnaire itself. First, there is no oversight or approval by an Institutional Review Board (IRB). I’ve written extensively about what IRBs are and why they are so important in safeguarding the safety of human research subjects and guaranteeing that human research projects are ethical and safe. IRBs are mandated and regulated by the Common Rule, the federal rule that covers all federally-funded human research. Although approval and oversight by an IRB is not guarantee that a human subjects research project is ethical and safe (witness how Mark and David Geier have managed to pervert the Common Rule and set up an “IRB” with glaring conflicts of interest), research that is not overseen by an IRB according to the Common Rule must automatically be considered suspect.

Of course, the problem with Tassano’s “research” is that it is not federally funded and thus may not be subject to the Common Rule. I say “may” because some states, such as Maryland, have laws that require that any human subjects research, whether federally funded or not, must adhere to the Common Rule and be approved by a properly constituted IRB before being undertaken. I was unable to determine if California is one such state; if California does have such a law, then what Tassano is doing by sending out this questionnaire is clearly illegal. At the very least, it’s highly unethical, not to mention appallingly bad science, given the horrible design of the questionnaire itself and the lack of informed consent. I find it most ironic that defenders of Jim Tassano are so quick to attack big pharma, given that no pharmaceutical company could ever get away with such a slipshod “study” and that any human study undertaken by big pharma requires IRB approval as part of the process of obtaining FDA approval. No pharmaceutical company could get away with what Tassano is doing, nor could any university-based researcher. Yet Tassano apparently can, at least for now, and not only is he not shut down because of it but he is praised for it by the very same people who castigate big pharma for its misdeeds. I find this to be a curious and frustrating double standard.

But what about Tassano’s “survey” itself? Tassano begins with this appeal:

For the sake of all cancer patients we need to collect data on DCA use. I am hoping you can spare a few minutes to fill out the survey below. We will post the data in a database form on . As you know, DCA is experimental, and you were among the first to use it. I hope you will share with us. Your name and contact information will be kept confidential, and will not be posted.

Do the best you can. We know that it is still early for some people to say much, but even that is useful. You can update your information as time goes by. Positive or negative, we need to know.

I really, really have to wonder if there is a potential HIPAA violation here, in addition to the sheer lack of ethics involved in this. Tassano has a vested financial interest in the outcome of this “research.” True, the same can be said of pharmaceutical and biotech companies, but no pharmaceutical or biotech company could never get away with the sort of “research” that Tassano is claiming to do. None. Moreover, any person, company, hospital, or researcher who deals with private patient information must follow the HIPAA Privacy Act, the federal law regulating patient privacy and the protection of patient data by healthcare providers and medical researchers. The law is quite detailed and enumerates the measures that must be taken to protect patient privacy. There are standards for e-mail communication and encryption and standards for software used to deal with patient information that must be adhered to. Yet here an amateur researcher with no healthcare experience at all, much less experience doing clinical research or properly protecting patient privacy, is soliciting private patient information by unencrypted e-mail and saying that he will post it to his website. Sure, he’ll remove the name, but HIPAA is quite clear that all patient-identifiable information must be protected, which means that any information that would allow people to identify a patient must be protected. Does Tassano have the first clue about any of this?

I’ll leave you to speculate about the answer to that question.

One thing that struck me right away as rather amusing is that, even after his bold assertion last week that he has always wanted to be “up front” about what he is doing, Tassano still remains disingenuous about the whole “PetDCA” dodge, asking survey recipients whether the DCA that they purchased was used in pets or not. Tassano should just stop the B.S. and stop pretending that his product is designed to be used by pets, rather than humans with cancer, who clearly make up the overwhelming majority of Tassano’s customers. But that’s a relatively minor concern; more disturbing are these questions:

16. Are you using DCA with chemo now? If so, which chemos?

Whatever the efficacy (or lack thereof) that DCA might have against cancer, I find it very disturbing that so many patients are taking DCA with chemotherapy and apparently not telling their oncologists. Even though the toxicities of DCA are fairly well known (peripheral neuropathy, for example), no one knows what interactions it may have with standard chemotherapeutic drugs used by cancer patients. For all we know, when mixed with certain chemotherapeutic drugs, DCA could kill.

However, the question that reveals more than any other on the survey the mindset behind Tassano’s irresponsible encouragement of self-experimentation with DCA is this question:

20. Do you think DCA is working for you? Why or why not? Scans? Examinations? Blood level testing? Here, I encourage you to freeform answer.

“Do you think DCA is ‘working’ for you?”

“Do you think?”

This question, above all others, shows the true mindset going on at One of the hallmarks of clinical research about whether an anticancer treatment has any efficacy is objectivity. What are the objective measures of antitumor efficacy? Does the treatment prolong survival? If so, by how much? Does the treatment cause tumors to shrink? If so by how much? it doesn’t really matter if the patient thinks a treatment is “working” if there is no measurable evidence that it is causing tumor shrinkage or an increase in survival. “Think” has nothing to do with determining whether an anti-tumor treatment is “working” if by “working” you mean prolonging life or shrinking the tumor. In the DCA world of Jim Tassano, however, the key question is not whether there is objective, measurable evidence that DCA has an anti-tumor effect and/or prolongs survival. No, in world of Jim Tassano, what matters is whether the patient thinks that DCA “works.” Never mind that, as I pointed out last week, there is as yet no objective evidence of an antitumor effect attributable to the activity of DCA. I wish there was, but there isn’t. Without a properly designed control group and experienced oncologists who know what to measure to determine the progression or regression of tumors, it is not possible to answer this question, barring “miracle cures,” which to date have not been observed with DCA. There is indeed an important role for patient questionnaires in clinical research protocols in cancer, but usually mainly for assessing quality of life, but here Tassano can’t seem to distinguish between objective antitumor responses and quality of life.

One lesson I take away from the whole DCA phenomenon is just how pervasive distrust of big pharma is. Sometimes it’s justified, sometimes not, but it exists nonetheless in a particularly virulent form, resulting in a double standard that leaves scammers like Jim Tassano viewed as praiseworthy for highly unethical activities and (very likely) breaking state and federal laws. If big pharma were doing half the things that Tassano is doing, the hue and cry from the people praising him now would be deafening–and rightly so. Worse, regulatory agencies normally responsible for preventing dangerous fiascoes like The DCA Site seem powerless to act to stop Tassano, despite complaints by me, you my readers, and others. Yet the same people who defend Tassano routinely rake these same state and federal agencies over the coals for their well-publicized failures to hold big pharma to account for its misdeeds, apparently not realizing that, if these regulatory agencies had the teeth that they should have, someone like Jim Tassano would have been shut down a couple of months ago. In any case, from my point of view, all entities selling pharmaceuticals should be subject to the same standards, both legal and moral. That includes every entity from the massive Pfizer or Bristol-Myers-Squibb to “little guys” like The DCA Site.

Unfortunately, Jim Tassano continues to flout his disdain for this concept and, sadly, is still getting away with it by painting himself as the “little guy” fighting to bring a chemotherapeutic drug that “big pharma isn’t interested in” to the masses, science be damned, ethics be damned, clinical research be damned. Meanwhile, his patients risk their health and possibly lives in unsupervised testing of a new drug by taking it with other chemotherapy.

ADDENDUM: Walnut has posted his critique on Daily Kos as well.

All Orac posts on DCA:

  1. In which my words will be misinterpreted as “proof” that I am a “pharma shill”
  2. Will donations fund dichloroacetate (DCA) clinical trials?
  3. Too fast to label others as “conspiracy-mongers”?
  4. Dichloroacetate: One more time…
  5. Laying the cluestick on DaveScot over dichloroacetate (DCA) and cancer
  6. A couple of more cluesticks on dichloroacetate (DCA) and cancer
  7. Where to buy dichloroacetate (DCA)? Dichloroacetate suppliers, even?
  8. An uninformative “experiment” on dichloroacetate
  9. Slumming around The DCA Site (, appalled at what I’m finding
  10. Slumming around The DCA Site (, the finale (for now)
  11. It’s nice to be noticed
  12. The deadly deviousness of the cancer cell, or how dichloroacetate (DCA) might fail
  13. The dichloroacetate (DCA) self-medication phenomenon hits the mainstream media
  14. Dichloroacetate (DCA) and cancer: Magical thinking versus Tumor Biology 101
  15. Checking in with The DCA Site
  16. Dichloroacetate and The DCA Site: A low bar for “success”
  17. Dichloroacetate (DCA): A scientist’s worst nightmare?
  18. Dichloroacetate and The DCA Site: A low bar for “success” (part 2)
  19. “Clinical research” on dichloroacetate by A travesty of science
  20. A family practitioner and epidemiologist are prescribing dichloracetate (DCA) in Canada
  21. An “arrogant medico” makes one last comment on dichloroacetate (DCA)

Posts by fellow ScienceBlogger Abel Pharmboy:

  1. The dichloroacetate (DCA) cancer kerfuffle
  2. Where to buy dichloroacetate…
  3. Local look at dichloroacetate (DCA) hysteria
  4. Edmonton pharmacist asked to stop selling dichloroacetate (DCA)
  5. Four days, four dichloroacetate (DCA) newspaper articles
  6. Perversion of good science
  7. CBC’s ‘The Current’ on dichloroacetate (DCA)

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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