Respectful Insolence

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 BuyDCA.com.

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 TheDCASite.com, 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 www.theDCAsite.com . 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 TheDCASite.com. 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 (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)

Comments

  1. #1 TheProbe
    May 21, 2007

    I believe you have commented on the utterly poor quality and lack of biological plausability of the studies being funded by NCCAM. Here, however, there is evidence which suggests that DCA is something worth looking at because of the rodent studies and the plausability of bilogical action. I wonder if Tassano would like to apply for the funds through NCCAM and take a real shot, at a real research center, and see whether DCA can stand the test of scientific inquiry?

    Perhaps he should be invited for some one-on-one RI?

  2. #2 Infophile
    May 21, 2007

    I wonder if Tassano would like to apply for the funds through NCCAM and take a real shot, at a real research center, and see whether DCA can stand the test of scientific inquiry?

    After what he’s done now, do you really think he stands a shot of getting it? Besides that, I think we can pretty safely say he isn’t in this to find a cure and save lives; he wants to make money. If he wanted a cure, he would have tried to get the research done the right way in the first place, or at least would have been more scrupulous about how he designed his “experiment.”

  3. #3 vlad
    May 21, 2007

    I’m curious if there have been some studies showing effectivness why aren’t there clinical trials? No, I’m not a conspiracy monger, nor do I think “Big Pharama” is supressing it. Have there been clinical trials preformed but not widely published? Other than this quack has anyone looked at DCA for double blind clinical trials? I would think someone would have run a CT then publish the results. All “Big Pharma” would have to do is pattent the process for creating medical grade DCA and get insurance to cover it. If they are sooooo evil and greedy why hasn’t this happened?

  4. #4 TheProbe
    May 21, 2007

    Infophile asks: After what he’s done now, do you really think he stands a shot of getting it?

    NCCAM has funded stranger. However, I envision their rejections as being stamped with a large rubber stamp “Insufficient Woo”.

  5. #5 sailor
    May 21, 2007

    “I think we can pretty safely say he isn’t in this to find a cure and save lives; he wants to make money. If he wanted a cure, he would have tried to get the research done the right way in the first place, or at least would have been more scrupulous about how he designed his “experiment.”

    I don’t think we have evidence that he is in it for money alone. Most people would like to discover a cure for cancer. He is unlikely to be in the position to do the relevant science. As we can see from his bungled questionaiire he has no training in scence, and is probably not in a position to afford to hire those who are. A bit like those who believe in Wo or religion, he has faith in an idea and seeing where it leads. That he is making money out of it, may or may not be his primary motive, but from the evidence I have seen I don’t think we can be sure it is. The problem is that when he DOES make money from it, it will be very hard for him to give up even when he realizes there are no benefits. Money corrupts.

    As for the legality. Well the questionaire is sort of after the fact. This is not in any sense a scientific work, so I doubt he would be prosecuted.

  6. #6 Rev. BigDumbChimp
    May 21, 2007

    21. How do you rate your health compared to when you started DCA?

    1. Much better

    2. Somewhat better

    3. About the same

    4. Somewhat worse

    5. Much worse

    mmmmmmmmmm sciency.

  7. #7 Orac
    May 21, 2007

    NCCAM has funded stranger. However, I envision their rejections as being stamped with a large rubber stamp “Insufficient Woo”.

    That’s exactly why NCCAM wouldn’t fund a trial on DCA: DCA is not woo. It very well might be an effective chemotherapy against cancer in humans. However, the way Jim Tassano is going about selling it is unethical, dangerous, and destructive to the clinical trials process.

    As for “sailor’s” comments, the reason Tassano’s “clinical trial” may well be illegal is because it is definitely human subjects research that was not approved by an IRB conforming to the Common Rule. If California has a law like Maryland’s that all human subjects research, not just federally-funded human subjects research, must conform to the Common Rule (which seems likely, given this statement in at the California Committee for the Protection of Human Subjects website), then Tassano’s survey is definitely illegal.

  8. #8 Calli Arcale
    May 21, 2007

    “Do you think DCA is working for you?”

    It is possible that Tassano is just another of the woefully (woofully?) many people who are scientifically illiterate. A lot of people believe that subjective experience is every bit as valuable as objective measurement. This is why people are willing to spend enormous amounts of money on magnetic bracelets, “natural” foods, and miraculous water from Lourdes. If they take the remedy, and think they are better afterwards, that shows causality.

    Actually, all it really shows is the tremendous power of the human brain to forge associations rapidly. This power makes us prodigious learners, but gets us in trouble when it comes to these sorts of things.

    So Tassano may be innocent — a victim of the widespread scientific illiteracy in this country. (He sure is profiting from his ignorance, though, if that is the case.) But I cannot help but notice that if his real interest is making money from DCA, his survey is right on the mark. From a sales perspective, whether or not people think it works really is the most important thing. Efficacy is of secondary importance.

  9. #9 ERV
    May 21, 2007

    Well this questionnaire completely busts his ‘Pet DCA’ cover. Combined with the previous incarnations of BuyDCA.com, why cant the FDA stop him over claiming to cure cancer, regardless of whether CA has an all encompassing Common Rule law?

  10. #10 Whatever
    May 21, 2007

    What bothers me is that people seem to be buying into the whole thing. This headline “Scientists cure cancer, but no one takes notice” is one of the top stories on digg. Check it out for yourself.
    http://digg.com/news/popular/7days

  11. #11 Whatever
    May 21, 2007

    What bothers me is that people seem to be buying into the whole thing. This headline “Scientists cure cancer, but no one takes notice” is one of the top stories on digg. Check it out for yourself.
    http://digg.com/news/popular/7days

  12. #12 sailor
    May 21, 2007

    “As for “sailor’s” comments, the reason Tassano’s “clinical trial” may well be illegal is because it is definitely human subjects research that was not approved by an IRB conforming to the Common Rule.”

    My point is that there is no clinical trial, this is just a questionaire. There was no protocol and in theory he is not even supplying any drugs. The ones he is giving are for pets. Let us forget his implication in supplying the medicine for a moment, would the questionare alone be against the law?

  13. #13 Whatever
    May 21, 2007

    What bothers me is that people seem to be buying into the whole thing. This headline “Scientists cure cancer, but no one takes notice” is one of the top stories on digg. Check it out for yourself.
    http://digg.com/news/popular/7days

  14. #14 Orac
    May 21, 2007

    My point is that there is no clinical trial, this is just a questionaire. There was no protocol and in theory he is not even supplying any drugs. The ones he is giving are for pets. Let us forget his implication in supplying the medicine for a moment, would the questionare alone be against the law?

    It is clearly human subjects research; the definition of human subjects research is much broader than you appear to realize. I will admit, however, that perhaps I shouldn’t have used the term “clinical trial,” as it implies more organization than Tassano demonstrates and is only one type of human subjects research. In any case, a questionnaire given to patients taking an experimental drug in order to find out if the drug is working is human subjects research. Period. You see, that’s the point. Jim Tassano is too clueless about cancer and human subjects research that he doesn’t even realize that he’s doing human subjects research. Incompetent and highly unethical human subjects research, but human subjects research nonetheless.

    So, yes, if California has a law requiring all human subjects research conducted in the state to follow the Common Rule, then Tassano’s questionnaire would be against the law unless it was approved by an IRB and his work was overseen by that IRB. If California doesn’t have such a law, then, because Tassano’s “research” is not federally funded or part of the preliminary data to gain FDA approval, then it would just be highly unethical but probably not illegal.

  15. #15 Coin
    May 21, 2007

    Whatever: Although the first digg article there is clearly sensationalist and misleading, I’m actually a bit more interested in the second site linked there. I can’t tell whether that site is a good thing or not, but it seems at least to be done in the right spirit. Although I’m a bit confused about where the money goes, they imply that by donating you’re helping DCA get tested/to market, but the money seems to actually be going to some general Leukemia charity…

    By the way– has it been noticed that when you search google for “dichloroacetate”, the first thing you see is a big yellow-boxed “sponsored link” for buydca.com? I don’t know what Google’s policies on acceptable advertisers are, but I can’t help but suspect they’re being stretched or broken here.

    (I also notice BuyDCA advertises themselves as the “Purest DCA available”. I wonder whether that is true.)

  16. #16 ERV
    May 21, 2007

    sailor– My point is that there is no clinical trial, this is just a questionaire.

    Lots of psych studies are just surveys and such too, but you have to have IRB approval. Even for silly undergrad psychology-major projects.

    I was a psych minor, and I got better training in that department on the rules and regulations of human/animal research (just making surveys) than I did in the science department (doing actual research).

  17. #17 Willis
    May 21, 2007

    Orac, any thoughts on the questions (re metabolic-electrical remodeling and mitochondrial membrane potential) I asked on your previous post on this subject? I would really like to hear your thoughts. I think that what is suggested is a much more fundamental role for metabolism in carcinomas.

    http://scienceblogs.com/insolence/2007/05/dichloroacetate_and_the_dca_site_a_low_b.php#comment-433808

  18. #18 sailor
    May 21, 2007

    Thanks Orac and Erv, I now understand.

  19. #19 Jud
    May 22, 2007

    Orac: “So, yes, if California has a law requiring all human subjects research conducted in the state to follow the Common Rule, then Tassano’s questionnaire would be against the law unless it was approved by an IRB and his work was overseen by that IRB. If California doesn’t have such a law, then, because Tassano’s ‘research’ is not federally funded or part of the preliminary data to gain FDA approval, then it would just be highly unethical but probably not illegal.”

    I’d like to gently caution against doing the sort of thing that might make you cringe if the roles were reversed. Let’s say you hear a lawyer opining “Clearly, blah, blah, blah…” on a medical topic you know something about. As an amateur, he generalizes, oversimplifies, and draws conclusions that you know aren’t supportable without detailed personal medical knowledge about the case that he doesn’t have. As a professional, you know that he’s unaware just how much he doesn’t understand, so it all seems relatively cut and dried to him.

    I know you do have a good understanding of the law regarding human subjects research and privacy – for a non-lawyer. But a lawyer would never generalize to the extent you are doing above in your post and comments with regard to whether particular conduct is “clearly illegal,” or whether there are HIPAA privacy problems here.

    Just saying.

  20. #20 Jud
    May 22, 2007

    Orac: “So, yes, if California has a law requiring all human subjects research conducted in the state to follow the Common Rule, then Tassano’s questionnaire would be against the law unless it was approved by an IRB and his work was overseen by that IRB. If California doesn’t have such a law, then, because Tassano’s ‘research’ is not federally funded or part of the preliminary data to gain FDA approval, then it would just be highly unethical but probably not illegal.”

    I’d like to gently caution against doing the sort of thing that might make you cringe if the roles were reversed. Let’s say you hear a lawyer opining “Clearly, blah, blah, blah…” on a medical topic you know something about. As an amateur, he generalizes, oversimplifies, and draws conclusions that you know aren’t supportable without detailed personal medical knowledge about the case that he doesn’t have. As a professional, you know that he’s unaware just how much he doesn’t understand, so it all seems relatively cut and dried to him.

    I know you do have a good understanding of the law regarding human subjects research and privacy – for a non-lawyer. But a lawyer would never generalize to the extent you are doing above in your post and comments with regard to whether particular conduct is “clearly illegal,” or whether there are HIPAA privacy problems here.

    Just saying.

  21. #21 Jud
    May 22, 2007

    Apologies for the double post. Got a server error first attempt and thought it didn’t go through.

  22. #22 Orac
    May 22, 2007

    Point taken, although I never said that Tassano’s work is breaking the HIPAA Law–only that it might be or at the very least that it’s a problem that he hasn’t considered that could get him into legal trouble. I honestly have no idea why you lumped HIPAA in with my last comment.

    Similarly, it should be obvious that this is my opinion based on my understanding of how clinical research is done and the law. It’s possible that it’s wrong, but Tassano’s activity looks very much as though it violates the Common Rule; so it is not an unreasonable inference that, if California’s law governing human subjects research incorporates the Common Rule, then Tassano’s activity would probably be illegal. The only thing I might change is to add the word “probably” to what I said.

  23. #23 qetzal
    May 22, 2007

    Whether the questionnaire constitutes illegal human subjects research seems beside the point to me.

    Since Tassano is clearly clueless about testing new drugs in humans, I suspect he’s equally clueless about making new drugs for humans. That strikes me as a much bigger concern.

  24. #24 Jud
    May 22, 2007

    Orac said: “The only thing I might change is to add the word ‘probably’ to what I said.”

    Re “probably,” I don’t see it as the universal deodorant for overly sweeping statements that some might think it to be. :-) Let’s look at the first step in the chain: is Tassano conducting human subjects ‘research,’ illegal or not? Or is he simply wanting to get a better idea, in his own layperson’s (or enterpreneur’s) understanding, of how those who’ve used his product are doing? What are the legal characteristics that define human subjects research, vs. less formal questionnaires or people trying to satisfy curiosity, perhaps commercial curiosity, or any other manner of thing Tassano’s questionnaire might represent? Are people who have already purchased DCA and have been taking it voluntarily, and who are only later asked to report anecdotally, the types of individuals the government seeks to protect under the Common Rule? (E.g., is there a danger that Tassano will seek to use these results to enhance his credibility as a researcher or faculty member, or his eligiblity for future federal or private research grants, and will thus seek to minimize the dangers of his ‘study’ to prospective volunteers?) Are there decided/reported cases on the issue? From courts in the controlling jurisdictions? Have those decisions been praised/followed/criticized/distinguished/restricted by other courts? Law review articles? From prestigious reviews or lesser ones?

    I don’t think “probably” expresses the potential complexities of these issues, any more than you would think saying “DCA *probably* will prove helpful to cancer patients” would be an adequate corrective for the disregard of complex medical issues in that statement.

    Regarding HIPAA, there’s the basic assumption that it might possibly apply. Might it, or is Gramm-Leach-Bliley (GLB) more appropriate, or is it neither? If you’re not familiar with GLB, I’d say you’re in the situation that the legal knowledge you have is a hammer, so most legal issues are looking like nails to you. :-)

    Sorry for the long-winded answer – I know you said “point taken” – but heck, I get so few chances to hold forth about these things.

  25. #25 Coin
    May 22, 2007

    I tried making a post in response to Jud on the subject of trying to tease out the legal definition of “human subjects research”, but I don’t really feel today like potentially making an idiot of myself in front of an actual lawyer (?), so [select all] [delete]. However, I do want to say this:

    After poking at Google, I am getting the impression that California does not have a universal legal requirement that research be subjected to an IRB, except (??) in the special cases when death certificates or stem cells are involved in the research.

    However, there is separate California legislation about research that involves human subjects, and I think it is worth glancing over to anyone interested in this discussion…

  26. #26 Chris Noble
    May 23, 2007

    I imagine that Tassano wants to have his cake and eat it too. He wants to collect evidence to support his claims but he doesn’t want to take responsibility for his actions. He’ll tell one story to his customers and another to the authorities.

    Here is another case of a “clinical trial” that all of a sudden isn’t a clinical trial when it suits.

  27. #27 Jud
    May 23, 2007

    Hi, Coin. Yeah, I’m an actual lawyer. I haven’t done a great deal in the area of human subjects research, beyond drawing up consent forms in one instance (adhering closely to specific requirements set out in HIPAA regulations) for patients receiving disease management services to share information on their progress for purposes of a study. (That study, by the way, did have an IRB.) But I am by no means any sort of expert on the legal requirements involved in human subjects research. Please take all comments I make in this thread in light of that state of knowledge (or lack of it).

    Regarding “the legal definition” of human subjects research, there can be, and likely are, many different definitions. Each specific law or regulation relevant to some aspect of the situation can have its own definition.

    But speaking in layman’s terms, there has got to be a cutoff point. If General Mills puts a card in Cheerios boxes saying “Hey kids! Were you a 90-pound weakling? Tell us how Cheerios made you bigger and stronger!”, that’s undoubtedly asking for medically relevant information, but is it human subjects research? Does Tassano’s request for information fall on the Cheerios side or the Matthias Rath side (see Chris Noble’s link above) of the line? Because I’m not expert in these matters, there may well be an easy answer to that question (some critical factor common to the definitions of “human subjects research” in all the laws that might conceivably apply to Tassano’s actions, for example) that I’m completely missing.

  28. #28 Orac
    May 23, 2007

    Having dealt with IRBs before, I can say that Tassano’s questionnaire almost certainly falls under the purview of the Common Rule, if that helps.

  29. #29 Jud
    May 23, 2007

    After a bit of research, some tentative conclusions, with a big caveat: Since I’m not directly involved, what I’m doing can be analogized to attempting a medical diagnosis based on fragmentary secondhand knowledge. In other words, take the following with a large shaker of salt.

    Tassano’s activities are likely *not* touched upon by HIPAA privacy regulations, IMHO, because he is not a “covered entity.” “Covered entities” are health plans (health insurance companies); health care clearinghouses (data centers that take insurance claims from doctors and hospitals and send them to insurers); and health care providers (doctors and hospitals). Tassano is none of these. He does not appear to fall under some extended definition of “health care provider” – Bayer, Pfizer, etc., aren’t health care providers under HIPAA, so Tassano doesn’t become one just by selling some DCA.

    If someone in Orac’s world did what Tassano is doing, there would be plenty of HIPAA concerns, because in his world doctors and hospitals are thick on the ground. But Tassano isn’t part of that world, and HIPAA is most likely not involved.

    A quick look at information about the Common Rule (45 Code of Federal Regulations Section 46) raises similar concerns about its applicability. For instance, see the Congressional Research Service report, “Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule,” http://www.fas.org/sgp/crs/misc/RL32909.pdf at pp. CRS-6 and CRS-18. It appears that generally, the Common Rule applies mandatorily only to research funded or conducted by federal agencies. I think we can pretty well assume Jim Tassano isn’t getting federal funding. The Common Rule does extend to some situations where federal agencies don’t fund the research but have jurisdiction, but FDA likely lacks jurisdiction over DCA at the moment.

    Again, in Orac’s world, where research almost certainly will have some federal funding or come under the jurisdiction of some federal agency, what Tassano is doing would be problematic under the Common Rule. But Tassano’s not part of the world of legitimate medicine.

    Just as a postscript to this section of the comment, it appears my concern that the anecdotal, sloppy nature of Tassano’s information gathering could prevent it from being considered “research” under the Common Rule may have some support in fact. The definition of research in Section 46.102 of the Rule speaks of a “…*systematic* investigation, including research development, testing and evaluation, designed to develop or contribute to *generalizable* knowledge.” (Emphasis added.)

    Circling back to my initial comment in this thread, what I’m saying is: In areas outside our expertise, we don’t know what we don’t know. Accordingly, we should try to speak and act with caution. I very much look forward to continuing to learn from your excellent posts regarding medical topics. Continued legal pronouncements, maybe not so much. ;-)

  30. #30 Orac
    May 23, 2007

    Speak and act with caution? Come on, this is the blogosphere!

    One thing that almost certainly wouldn’t fly is claiming that, because Tassano is incompetent at “research,” that it would exempt him from the Common Rule because his incompetence makes his questionnaire too poorly done to qualify as “research.” For one thing, Tassano has said time and time again that he hopes his “work” will lead to knowledge about whether DCA works against cancer. This quesitonnaire, as incompetently crafted as it is, is clearly intended to further that end and produce “generalizable knowledge.” Second, the definition for what constitutes “research” is in practice considerably broader than the wording of the Common Rule, perhaps unjustifiably so, given how IRBs have expanded upon the Common Rule of late.

    No, there is little doubt in my mind that Tassano’s activities fall under the Common Rule and that he is treating his customers as human research subjects for purposes of this survey, even with his being “in another world” than the one in which I operate. However, as I myself noted, he is not federally funded or seeking FDA approval; so the federal Common Rule, alas, doesn’t apply to him. That leaves, as I also pointed out, the sole question of whether California has an applicable law, which it well may not.

    As for HIPAA, I merely pointed out that Tassano is clueless about it and that cluelessness about it, as he is about pretty much all the legal and ethical considerations that go into his activities. I didn’t really get Personally, my hope is that the FDA finally gets off its butt and shuts him down, making my speculation about IRBs and HIPAA moot.

  31. #31 silver
    May 24, 2007

    When your Doctor tells you to go home and die it is the last straw and all hope is lost..
    Hope is a powerful force and if the DCA is only a good placebo then what harm is done.
    It has fairly well known side effects and the cost not a lot more than asprins. After using it for 4 weeks it has improved my life, is that scientifically factual? yes for me it is and even if it is no cure at least I feel hope, and of course I am not being screwed for $1,000 like the chemo costs. It may yet turn out that DCA is at least as effective as chemo which clearly has major drawbacks and cures only a few types of Cancer.
    (No I did not buy my DCA from Tassano but would have happily if I could not have found another source)

  32. #32 Jud
    May 24, 2007

    Orac said: “Speak and act with caution? Come on, this is the blogosphere!”

    My turn to say “Point taken.” :-)

    Silver said: “It may yet turn out that DCA is at least as effective as chemo….”

    As has been pointed out here and elsewhere, DCA *is* chemo, just chemo with no good research into its effectiveness. Yes, it may be relatively cheaper, so if you’re throwing away money, at least you are throwing away less of it.

    Re going home to die, hope, placebo effect, etc. – I suppose all of us must make our own accommodations with the thought of more or less impending death. If you choose to rage against the dying of the light, then the very best to you in doing so. But we may also have our own reasons for anger, as we see those who are more vulnerable, with less clear-eyed acceptance that DCA may be only a placebo (or worse – there are potential negative side effects) than you have their precious hope and perhaps chances at life manipulated by those who see financial opportunity when others are at their weakest.

  33. #34 impatientpatient
    May 26, 2007

    I was just going to post about the Toronto docs using DCA.

    Would love to see what you have to say Orac.

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