The dichloroacetate (DCA) “self-experimentation” phenomenon hits the mainstream media

It figures.

Whenever I go away for a conference, things of interest to me that I’d like to blog about start happening fast and furious. Indeed, I could only deal with one of them, and I chose to post my challenge to the Paleyist “intelligent design” creationist surgeon, Dr. William Egnor. Now that I’m back, I’ll deal with the other major issue that’s been a frequent topic of blogging over the last couple of months and bubbled up again into the blogosphere over the weekend.

Remember all the posts that I did on dichloroacetate (DCA), the small molecule chemotherapeutic agent that targets the Warburg effect and seems to have a wide spectrum of activity against tumors in rat models of human cancer, the report of which back in January triggered a blogospheric meltdown of conspiracy-mongering and credulity about a “cure” for cancer that big pharma is keeping from you, even though only animal data shows promise and the drug has never been tested in humans against cancer? Remember how I wrote about Internet “entrepreneurs” claiming to sell DCA for people to use on their “pets” with advanced cancer and how I demonstrated conclusively that that claim was a lie, that the purveyors of false hope selling DCA at The DCA Site knew damned well that people were primarily buying their “Vet-DCA” for human consumption? Remember how “Heather,” the “administrator” of the DCA site changed the site, chameleon-like, in response to my criticisms, something that has occurred yet again, so that the site BuyDCA.com features its prominent (and bogus) disclaimer that DCA is not to be used in humans even more prominently?

The mainstream media is finally noticing, as my blog buddy Abel reports, pointing me in the direction of a story from Friday in the Edmonton Journal about the hype over DCA and the unscrupulous and reckless actions of Jim Tassano, who has been revealed as the person responsible for The DCA Site:

Yet Jim Tassano, a biologist in Sonora, Calif., said he created the DCA website in early February because he doesn’t want his ballroom dance instructor to die of cancer. The website, www.thedcasite.com, is a direct result of Michelakis’s research, Tassano said.

Tassano and a chemist from the University of California have begun making DCA and selling it over the Internet. The buydca.com site says the compound is for experimental treatment for pets with terminal cancer, but Tassano said he knows people are buying it for themselves or family members as well.

“There are unknowns, but at a low dosage rate, if I were a cancer patient, I would take it,” said Tassano, 54. “Are there side-effects? Absolutely, but compare that to radiation.”

He said waiting for clinical trials isn’t an option for dying people.

“What’s the worst that can happen here?” he asked in a telephone interview. “Is it fair to let people die and not do anything about this?”

I’ve addressed this issue before in detail here and in multiple posts about DCA. Such self-experimentation is not only dangerous, but highly unlikely to produce any useful data, barring the small possibility that DCA is truly the “miracle” cure that it is claimed to be. The bottom line is that this “wild self-medication” represents not only a danger to the desperate patients who have fallen for the sales pitch of people like Jim Tassano and the credulous blogospheric hype over the discovery of DCA. It’s good to see that Dr. Evangelos Michelakis, the principal investigator who published his findings on DCA in Cancer Cell in January, is on the same wavelength as I am:

“We are concerned,” said Michelakis, who set up a website with the U of A saying he doesn’t condone or advise the use of DCA in humans. The site has received more than 141,000 hits and Michelakis has received more than 10,000 e-mails from people eager to become involved in clinical trials.

“We absolutely do not support the use of this drug to patients with cancer any way out of a clinical trial. There are a number of risks associated with it, and unfortunately patients and physicians are exposing each other to these risks.”

And, contrary to the message that Jim Tassano is promoting at the DCA Site, DCA is not without a significant risk of complications in adults:

In clinical trials to see how DCA works on metabolic disorders, children took the drug and showed no signs of toxic poisoning.

But when the same trials were done on adults, most had to discontinue using it, since they developed severe peripheral neuropathy, Michelakis said. The damage to the peripheral nerves caused imbalance and finger numbness.

While the effects were reversible, Michelakis said if people take DCA while also undergoing other cancer treatments, the consequences could be lethal.

“Most of the anti-cancer drugs that we currently use are neurotoxic themselves,” he said. “So a patient who has been exposed to these drugs and now tries DCA might have a severe form of peripheral neuropathy. This patient might have severe problems that he cannot walk or he cannot touch or feel.”
Even for those who say they have only six months to live and nothing to lose, Michelakis said it’s not worth the risk.

“Of course you have things to lose, because you can die earlier and in much worse shape,” he said.
He said self-medicating without proper supervision has broader implications.

“It’s a public health threat if you start using on your own and acting out of your own desperate situation,” he said, noting that people taking DCA have no mechanism to formally report side-effects and complications. Nor can they know if the compound is pure.

“That’s the worst nightmare in medicine, to start making judgments on whether a drug is good or bad based on what any patient will post on a blog. This is the death of medicine and organized research as we know it.”

Indeed it is. It’s a throwback to the era before the FDA, where snake oil peddlers could sell any “remedies” they wanted and make any claims for those remedies that they wanted, all without any regulation. Patients had no idea what they were getting or whether it would be safe and effective, and the only recourse they had would occur when enough problems cropped up from a patent medicine seller’s wares to result in his being run out of town on a rail. But it’s worse than that. The Internet and the blogosphere amplify a million-fold the ability of people supporting or selling unproven “cancer cures” by providing a world-wide reach that 19th century hucksters could only dream about.

Michelakis sounds like a good man. He seems reasonable, and he knows what the issues are. As hard as it may be to believe, even if you have a terminal illness with only months to live, things can get worse. One thing worse than dying of cancer is hastening your end in a painful way; i.e., wasting the little time that you have left for a drug that has a low probability of curing you and an only so-so possibility of even helping. Indeed, one reason that we as surgeons are often reluctant to do palliative operations for some forms of abdominal malignancy is because the recovery time could well be a significant proportion of the little time the patient has left, and, if there’s a significant complication, the patient could well spend his or her remaining days in the hospital. We try to avoid that and give the patient as much time at home before the end as is possible. In any case, coming back to DCA, peripheral neuropathy can be a particularly nasty complication of some chemotherapy drugs, particularly drugs that block microtubule activity or assembly. Just ask any medical oncologist. It’s a dose-limiting toxicity of certain chemotherapeutic drugs like Taxol that can have a severe impact on the quality of life of cancer patients. Dr. Michelakis is absolutely correct: If a cancer patient is already on one or more of the chemotherapeutic agents that can cause peripheral neuropathy as a side effect and takes DCA without telling his or her oncologist, it’s entirely possible that the toxicities of the drugs (the chemotherapy and the DCA) to nerves could very well be synergistic.

Unfortunately, Dr. Michelakis has no control over the misguided and ethically very dubious actions of Jim Tassano, the owner of Foothill Sierra Pest Control in Sonora, California, who, while donning the mantle of the patient advocate who is bucking the system to save lives, is even now trying to drum up business by soliciting testimonials on his website from people who have used DCA, all the while regularly altering the content of his site to try to stay one step ahead of the FDA. I definitely feel for Dr. Michelakis. I’m guessing that his conscience is bothering him, even though he’s done nothing wrong and has no control over how the story of his discovery has been spun. He’s quite correct; if patients can start taking various experimental drugs outside the context of clinical trials, it could indeed mean the death of organized research as we know it. There’d never be a way to definitively find out if new drugs worked because no one would want to sign up for clinical trials. Why should they if they could get the drug outside the context of a clinical trial? Nobody wants to deny dying patients what they perceive to be a shot at a “cure,” but, n the end, such an outcome would end up harming far more cancer patients than it would help and, in fact, would be quite unlikely to help even a few.

Similarly, contrary to the claims of Jim Tassano and his supporters on the discussion boards at the DCA Site, a “database” consisting of a bunch of desperately ill self-medicating cancer patients will not produce much, if any, useful data. There are now several examples on these discussion boards of desperate patients are looking at any blips in blood values, regardless of whether the “markers” they are looking at have ever been shown to correlate reliably with tumor burden. In fact, there are very few blood markers that do correlate with tumor burden reliably (CEA and PSA, for example) and even these are subject to many confounding factors and variables. I noted with dismay at least one example of using useless “tumor markers” as “evidence” that DCA is “working,” specifically this man, who is looking at upward blips in his serum copper and concluding that his tumor is dying, even though serum copper is such a nonspecific marker that making such a conclusion is unwarranted. There’s a reason that clinical trials have such complex and detailed reporting requirements, and there’s a reason for double-blinding the trial groups. For one thing, the placebo effect, selective thinking, and confirmation bias will guarantee that most patients self-medicating with DCA will claim to feel better, whether or not there is any objective anti-tumor affect attributable to DCA. Similarly, those who do feel better, whether through placebo effect or not, will be far more likely to report it than those who notice no effect, thanks to the communal reinforcement that is clearly going on in these discussions. Meanwhile, patients measure blood markers that are very nonspecific and view any little glitch in a favorable direction as “evidence” that DCA is working. Well, it may be, or it may not be. Trends are what is important, and an objective observer is needed to determine whether there has been any objective evidence of antitumor activity. The plural of “anecdotes” is not “data,” and this is even more true for testimonials, which is all the information in this “database” is. The very reason for the existence of such formalized, randomized, double-blind clinical trials is the realization of how easily humans’ thinking goes wrong and to minimize the possibility of these errors producing an apparently positive result when in reality there is none.

Also, not suprisingly, in a case of the classic “pharma shill” gambit, the denizens of The DCA Site’s discussion boards are accusing the journalist who wrote the article, of being in the pocket of big pharma. Indeed, they’re turning on Dr. Michelakis because he has urged a Canadian pharmacy not to fill prescriptions for DCA for cancer and complaining without justification that they were being quoted without permission. (People, if you post to a public discussion board on the Internet, I have news for you: The newspaper probably doesn’t need your permission to publish your words.) It’s not an unexpected reaction; they simply don’t want to hear the message that this sort of unregulated experimentation is potentially dangerous, almost certainly won’t produce any useful data, and is very unlikely to help the very cancer patients engaging in it–a trifecta of reasons why it shouldn’t be permitted.

Given this article, I’m hoping that other major news outlets pick up on this story in order to expose the reckless and ill-advised activities of Mr. Tassano. However, I do realize that such publicity could backfire and stoke the demand for DCA all the more, even though more likely than not it will not be anything like a “miracle cure.” What people don’t seem to realize is that, had DCA been developed by big pharma soup to nuts and shown to have a comparable level of activity against tumors in rat models, it would have been a promising, but utterly unremarkable anticancer drug, at least compared to all the other anticancer drugs that make it as far in the pipeline as animal studies demonstrating tumor growth delay. Lots of drugs cause significant tumor growth delay in animals, as DCA did. Sadly, most drugs that show promise against cancer in animal trials ultimately fail to show comparable activity in human trials. That is a simple fact. Were it not for the whole “cure for cancer” that “big pharma” doesn’t want you to know about (or, as Kevin Trudeau would put it, “they” don’t want you to know about) angle, few outside of the scientists involved in DCA research and interested insiders would be likely to care that much about it. Certainly, no one would be trying to make home brew DCA to treat their friends with. There’s no doubt that DCA is a promising agent that needs to be studied in Phase II trials to determine if it works against common human cancers, but it’s not unique and it’s almost certainly not a cure.

The bottom line is that the only reason DCA is being represented as a “cure” for cancer by misguided and ethically dubious “entrepreneurs” like Jim Tassano, idiotic pseudoscientists like DaveScot, and a number of alties who seem to think that it is not chemotherapy (it is chemotherapy, by the way) is because DCA wasn’t developed by big pharma and big pharma has shown little interest in funding its further development. It makes a great story that alties just love: an abandoned drug that shows promise against cancer in animal experiments but is having difficulty attracting investment dollars from pharmaceutical companies, allowing full expression of their conspiracy theories. Even though it’s systemic defect in how drugs are developed and marketed in this country and not any sort of conspiracy, promising preclinical results in rats, coupled with its “unpatentability,” coupled with the understandable reluctance of big pharma to spend a lot of money to get it approved, have all combined into a perfect storm, leading to travesties like Jim Tassano’s “Vet-DCA” and the even more distressing spectacle of dying cancer patients influenced by Tassano’s delusion go to great lengths to buy his DCA.

ADDENDUM: Hot off the presses this morning, a story about a patient who bought DCA but has since decided it’s not a good idea to use it. (Hat tip: Matt the Heathen.)

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 (TheDCASite.com), appalled at what I’m finding
  10. Slumming around The DCA Site (TheDCASite.com), 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 TheDCASite.com: 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)