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Just in time for my cancer class

In a few weeks, we’ll be having a discussion of the ethics of cancer research: what is a reasonable intervention in the case of a patient who has no hope of survival? And look at the interesting case that just appeared on my radar: two cancer surgeons who treated brain tumors by deliberately infecting them with bacteria.

Two UC Davis neurosurgeons who intentionally infected three brain-cancer patients with bowel bacteria have resigned their posts after the university found they had "deliberately circumvented" internal policies, "defied directives" from top leaders and sidestepped federal regulations, according to newly released university documents.

Dr. J. Paul Muizelaar, 66, the former head of the neurosurgery department, and his colleague, Dr. Rudolph J. Schrot, violated the university’s faculty code of conduct with their experimental work, one internal investigation concluded.

All three patients consented to the procedures in 2010 and 2011. Two of the patients died within weeks of their surgeries, while the other survived more than a year after being infected.

The premise behind their experimental procedure is probiotics, which immediately throws a warning on the play: there’s a lot of abuse of the concept out there.

Muizelaar and Schrot called their novel approach “probiotic intracranial therapy,” or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.

But there are some serious problems here. They didn’t have institutional review and approval of their procedure! That’s not a warning flag, it immediately calls the entire research into question and brings the ethics of the doctors under the microscope. You don’t get to do that.

And then there’s their logic. This is a disease with a median survival of 15 months. Their first patient died less than 6 weeks after the surgery, while the second lived for a year, which the report says “buoyed the doctors and seemed to bolster their theory”. That makes no sense at all — with so few trials they can’t possibly make that kind of assessment. Furthermore, their third patient died of sepsis.

At least it sounds like we’ll have something to talk about. That seems a paltry reward for three people’s deaths.

(via The Tree of Life)

Comments

  1. says

    I really understand the desire to find a way to beat cancer, however, it breaks my heart all three patients consented. They were all so terribly vulnerable, and desperate, I’m sure. Seems you need extra care, ethically speaking, in such cases.

  2. Nerd of Redhead, Dances OM Trolls says

    Dang, that’s what happens when doctors believe in newage* bullshit, rather than the reality. Didn’t improve survival at all….

    *rhymes with sewage°

  3. Matt G says

    The thing is, even if the patients had lived another 15 years it would still have been unethical. The ends do not justify the means.

  4. bryanfeir says

    And. of course, this sort of thing is precisely why we have Institutional Review Boards in the first place. So that researchers don’t take advantage of desperate patients.

    And really… bacteria in the brain is just a bad thing all around. And put there to ‘stimulate the patients’ immune systems’? Like throwing sand into an inefficient engine to get the mechanic to take a look at it? One of the things about cancers is they manage to avoid the immune systems, because if they didn’t, they wouldn’t get very far…

  5. says

    bryanfeir:

    And really… bacteria in the brain is just a bad thing all around.

    Yeah, the first thought to pop into my head was “wow, that seems a great way to guarantee they’ll die.”

  6. New England Bob says

    They should have NEVER tried this first on humans but on other mammalian species.

  7. Subtract Hominem says

    I know fuck-all about medicine and scarcely more about biology so this is probably a painfully stupid question, but

    how is this different from giving those patients bacterial meningitis and hoping it all works out somehow?

  8. says

    Sorry, but a lot of surgeon have no training in science and its not surprising that they didn’t think their “experiment” through. Sidestepping the IRB, that’s pretty bad, even surgeons should know not to do that. I wonder how they thought they were going to publish their findings.

  9. MarkM1427 says

    “Muizelaar and Schrot called their novel approach “probiotic intracranial therapy,” or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.”

    Yes, deliberately cause a brain infection that is difficult to treat even in someone who is otherwise healthy thanks to that whole “immune cells can’t just waltz past the blood brain barrier like it’s not even there” issue in a person who has a fucking tumor growing in their brain! What could POSSIBLY go wrong with that?

    The reason this didn’t get reviewed ahead of time is that anyone on a review board would have slapped the skin off the faces of these two doctors before asking “What the FUCK is wrong with you?”.

  10. sethmassine says

    Has anyone brought to PZ’s attention the recent happenings at Debunkingchristianity? I urge you to do so.

  11. nightshadequeen says

    Muizelaar and Schrot called their novel approach “probiotic intracranial therapy,” or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.

    Holy shit wrong epitopes, Batman!

    Also: I hate the phrase “stimulate the immune system”. Jesus Haploid Christ there’s so many branches of the immune system, which one (or ones) are you stimulating, again?

    Samantha

    Bacterial meningitis is a term that refers to any bacterial infection of the meninges [the protective layers covering the brain and spinal cord]. Enterobacteria can indeed naturally cause meningitis.

    These quacks apparently thought putting bacteria in the brain of patients with brain tumors was a good idea.

  12. says

    sethmassine:

    Let me just say

    How about if you don’t? If you can’t take the time to figure out there are two open threads here, don’t decide to dump off topic stuff in a thread.

  13. nightshadequeen says

    sethmassine:

    PZ’s email is listed under his picture, and if you’d like to bring up an unrelated topic for discussion, please do so in the Lounge or Thunderdome.

    Thanks.

  14. Funny Diva, naval gassing looser says

    Subtract Hominem,

    Bacteria vary widely in their toxicity and infectiousness. Most of us have no problem with our own gut and skin bacteria.
    Infecting someone with a strain that’s well known to kill would be different from what these surgeons did, (which was STILL stupid and WRONG), but only in degree. As Matt G points out, the end does not justify the means–even if the procedure had worked, these doctors should STILL be in hot water.

    Consent. It matters. Even when dealing with the IRB is a pain in the a$$. Which it often is. And even if you’re a surgeon, intent isn’t f*cking magic.

    Also: What MarkM1427 said. The brain is “shielded” or “privileged” from normal immune function for a reason. Why anyone with _any_ understanding of the immune system relative to the brain would see that this was a stupid idea.

  15. nightshadequeen says

    Funny Diva

    Most of us have no problem with our own gut and skin bacteria

    If said bacteria remained where they belonged, in gut or on skin.

    [E. coli can cause meningitis (although usually in newborns)]

  16. R Johnston says

    Point of order:

    Near as I can tell we aren’t dealing with “cancer surgeons” at all; this is about neurosurgeons with no particular cancer expertise, who conduct brain surgeries including surgeries on cancer patients, offering experimental treatments to cancer patients that weren’t even surgically based treatments. This is Burzynski Clinic level stuff.

  17. Funny Diva, naval gassing looser says

    and Nightshade Queen @13 deals with the question better than I. Thank you.

    Their whole concept is so full of FAIL it’s not even fractally wrong.

    And, “I’m sorry, but” any surgeon who doesn’t understand the science has NO BUSINESS doing experiments. Even on desperate, desperately ill patients.

    *rageflail*

    The one patient (of the three), that actually meaningfully survived the procedure still got a lifespan about 20% shorter than the _median_ without treatment. That is NOT a result to be optimistic about.

  18. raven says

    Actually there is a shred of logic in their experiment. One which they also seem to be totally unaware of.

    Coley’s toxins. Extracts of gram-bacteria used a century ago.

    They worked every once in a while. Didn’t work a lot of the time. And were very dangerous. IIRC, they were abandoned in the 1930’s.

    The theory is they worked by stimulating the immune system and cytokine production. Some cytokines have anti-tumor activities, interferons, IL-2, TNF, and so on. These days we’ve tried to enhance the bioresponse modifier activities and minimizes the toxicities.

    Of course, a cytokine storm will also kill you in hours or days as well.

    That being said, we gave up on Coley’s toxins nearly a century ago for good reasons. There is no point in reviving ancient remedies like bleeding, leeches, mercury, and exorcisms. (Although leeches do have an occasional niche application.)

    Anyone interested, look up Coley’s toxins.

  19. Funny Diva, naval gassing looser says

    Nightshade Queen: EXACTLY! I was going to put that caveat and then…didn’t. Another example of the “not even fractally wrong”-ness of these quacks’ harebrained idea. The more I think it over, the more I think they belong in jail, or at least fired by their university…not just allowed to “resign”.

    As R Johnston points out:

    This is Burzynski Clinic level stuff.

  20. raven says

    Coley’s toxins – Wikipedia, the free encyclopedia
    en. wikipedia. org/wiki/Coley’s_toxins‎

    Coley’s toxins (also called Coley’s toxin, Coley’s vaccine, Coley vaccine or mixed bacterial vaccine) is a mixture consisting of killed bacteria of species …

    Coley at least had the wits to use dead bacteria and was working before the first chemo drug was invented.

    1. Live bacteria in the brain? Haven’t they ever heard of bacterial meningitis or encephalitis? Cancer patients are frequently immune suppressed for various reasons and a common cause of death is sepsis, septic shock, multiorgan failure.

    I wonder if the two early patients died of encephalitis.

    2. Haven’t these guys ever heard of animal experiments and filing IND’s and so on?

    Anything going into humans spends a year or three in animal studies. Better a few dead mice than a dead patient.

  21. Funny Diva, naval gassing looser says

    Raven:

    I just Duck-Duck-Go’d Coley’s Toxins. And if these docs were unaware of them, they’re _even_ stupider than I thought. Because as near as I can tell, they’ve got a following in alt-med, DIY cancer-treatment circles. IOW: not actually abandoned in the ’30s. Not completely.

    The Toxins of William B. Coley and the Treatment of Bone and Soft-Tissue Sarcomas
    note that this still doesn’t address using live bacteria for brain tumors!

    Protip: this sort of brash exercise of one’s God Complex only works for James T Kirk in Star Trek movies.

  22. Nerd of Redhead, Dances OM Trolls says

    What were the control experiments? Best present therapies, or the wonder drug Placebo? I suspect there was no controls. Inquiring minds want to know…

  23. Funny Diva, naval gassing looser says

    Oh, Nerd, you big silly…
    None of that _matters_ when Important Surgeons are riding their Probiotic hobbyhorse to Glory!

    Neither rain, nor snow, nor IRB, nor piddling Directives from Top Leadership will prevent their completion of their self-appointed Mission!

    I just feel sorry for all the ethical researchers at that institution. This sort of thing gives _everyone_ a black eye, and puts _everyone_ under extra scrutiny. IOW: way to ruin it for everyone else!

    PS: not all clinical trials are of the double-blind, placebo-controlled variety. Even if this had been a fully thought-out, ethical and compliant study/procedure it wouldn’t have used that framework…
    Placebo would almost certainly have been better than introducing bowel bacteria, however!

  24. Seize says

    Lord have mercy, from a regulatory / patient-centered point of focus, this “intracranial probiotic” “therapy” is just…shitheaded. (She said, trying to use humor in order to cope with the truly awful).

    Where is the application to work in human subjects? Where is the 150-odd-page brochure summarizing the dozens of animal trials that justify use of a consenting human patient? Where are the additional justification for using patients with a diminished capacity to consent? (On our IRB forms, “cancer patient” and “terminal patient” are two separate, non-exclusive ticky boxes which would both have to be justified by the applicant). Who was the physician appointed to guard the interests of the vulnerable patient population?

    There are special types of applications you can use for “compassionate use” of an investigational therapy to treat a patient who is otherwise terminal, but these are extraordinary, highly-monitored circumstances. Medically-educated patient advocates with no connection to the researchers are central to this type of use. “Compassionate use” also isn’t something you can do in just any old patient. With therapy that might increase pain or cause harm, part of the argument that this use is from a compassionate ethical standpoint is that it gives the consenting patient an element of agency in their own terminal state. It isn’t compassionate to give unreasonable hope to a patient who is slated for the morgue; however, it may be compassionate to give an informed, consenting patient the knowledge that they have the capacity to do something that might have great significance for future patients. Again, researchers can’t make the call on their own in these cases because their own investment in a therapy will bias them. You need an IRB, a trained patient advocate and an appropriate patient to do this “the right way.”

  25. says

    If I were affiliated with UCD, I would be demanding the surgeons’ heads on a silver platter. At the very, very least, they should have their medical licenses pulled so hard they would not be able to give away vaccinations in a third world country.

  26. Seize says

    (“Lord have mercy” is intended here as a colloquial term spoken frequently by the poster which means, roughly, “Scramblin’ shitsnacks people, what the actual fuck!”

  27. Nerd of Redhead, Dances OM Trolls says

    You need an IRB, a trained patient advocate and an appropriate patient to do this “the right way.”

    “Bingo”. That fills my pseudoscience card.

  28. says

    @PZ – As a member of a community advisory board for HIV research, I would be interested in seeing your curriculum, if there is any way you could get some notes on line. I occasionally speak about ethical issues involved in medical research, and new material is always appreciated.

  29. Funny Diva, naval gassing looser says

    Seize: thank you for #28 and #30. You made me laugh…at something that’s awful and infuriating.

    Gregory in Seattle: vaccinations in a third world country? _I_ wouldn’t be letting either of these schmucks empty bedpans!

    Fortunately, this case is so far on the wrong side of a bright line ethically that it’s easy to be on the side of right. Unfortunately, ethical issues are more usually in the dreaded “gray areas”, and institutions and colleagues tend to be pretty reluctant to mete out penalties…let alone harsh ones.

  30. chrislawson says

    The patients probably weren’t so desperate that they consented — and there’s nothing wrong with patients in desperate situations consenting to desperate measures…the problem is that they likely consented to bullshit. That is, the surgeons probably told them a bunch of bafflegab because the surgeons themselves were clueless idjits.

    Here’s hoping that they not only lose their professional affiliation, but also their medical registration and that they get charged with manslaughter.

  31. raven says

    Because as near as I can tell, they’ve got a following in alt-med, DIY cancer-treatment circles. IOW: not actually abandoned in the ’30s. Not completely.

    I just read the wikipedia article myself.

    It’s not terrible but it has clearly been marched through by an army of quack alt med and conspiracy types.

    The fact is, these toxins have been around for over a century. If they had a favorable risk reward ratio, we would know it by now.

    For over 1/2 century, how to do a clinical trial and get a new drug approved has been common knowledge. Phage III blinded, randomized, controlled by placebo or best available therapy clinical trials. Hundreds at least are done in the USA every year. This isn’t brain surgery, more like a first grade coloring book.

    Coley was a pioneer who made a noble attempt at a time when there was more or less no cancer treatments available. We’ve moved on since then.

  32. says

    My god, if I were UC Davis’ legal counsel, I’d probably have throttled those two myself. The liability issues alone, not including the ethical issues and the fact that any results they might have gotten are essentially useless, have exposed the hospital to millions of dollars in damages (wrongful death, malpractice).

    And then there are the ethical issues, and the terrifying fact that neither surgeon appears to know a damn thing about actual medicine…….

  33. says

    Muizelaar and Schrot called their novel approach “probiotic intracranial therapy,” or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps.

    Was this a technique invented by Dr Mengele?

  34. Lyn M: ADM MinTruthiness says

    Canadian Criminal Code has this as part of the definition of murder:

    where a person, for an unlawful object, does anything that he knows or ought to know is likely to cause death, and thereby causes death to a human being, notwithstanding that he desires to effect his object without causing death or bodily harm to any human being.

    So the acts described are skimming along the edge of that definition. It seems to me the doctors were acting in a way that was likely to cause death. I’m not clear that the acts were unlawful in the criminal law sense, but sure seems to be in the sense of a civil wrong.
    The murder definition doesn’t quite fit, but it’s scary close. And that is astounding when you are supposedly talking about doctors providing treatment to a patient.

  35. karmacat says

    I have to say these doctors are really dumb. The reason for the blood brain barrier is TO KEEP INFECTIONS OUT. the bacteria is going to kill the patient before any immune system is going to do anything about cancer cells (if at all). On some level they must have thought it was a stupid idea or else they would have told more people about this.

  36. Lothar Lorraine says

    I am a Christian and I am militating for the legalization of all drugs for terminally ill patients. If they can get some pleasure from Cannabis, Heroin, Cocaine or LSD, what does speak against injecting them such drugs?

    They have absolutely nothing to lose.

    It is UTTERLY IRRATIONAL to authorize Euthanasia while prohibiting a terminal drug-induced trip.

    Lothars Sohn – Lothar’s son
    http://lotharlorraine.wordpress.com

  37. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    @Lothar Lorraine

    If you don’t remove yourself to Thunderdome, as suggested by Al Dente, you will be reported.

    I can’t tell if your suggestion of legalizing use of CHCandL is supposed to be argumentum ad sarcasm or just flip in tone, but you are off topic and offensive either way.

    Get to thunderdome or just get gone.

  38. Lyn M: ADM MinTruthiness says

    karmacat 43

    On some level they must have thought it was a stupid idea or else they would have told more people about this.

    Oh, clearly you don’t get it. All the really great scientific pronouncements were made after secret work. The scientist could then leap from the shadows and yell, “Eureka!” Which is Greek for “Surprise!”
    It was proving to be really, really hard for CERN, though, so they buried it.

  39. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    @Lyn M.

    Yes, the Canadian Criminal Code does indeed contain that section.

    However the Supreme Court of Canada has ruled that it is unable to be used. No one can be convicted under the so-called “constructive murder” statute unless the crown wants to be immediately reversed on appeal.

  40. Lyn M: ADM MinTruthiness says

    Thanks Crip Dyke. If you have a citation, I would appreciate it as I can then get this straight in my head.

  41. says

    @ Lyn M: ADM MinTruthiness #47

    All the really great scientific pronouncements were made after secret work. The scientist could then leap from the shadows and yell, “Eureka!” Which is Greek for “Surprise!” It was proving to be really, really hard for CERN, though, so they buried it.

    That one triggered a bout of “airless” silent laughter followed by bellowing guffaws that frightened my neighbors. I hope you’re proud of yourself and your dangerous sense of humor (you almost killed me with that one). ;-)

  42. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    I’ll look it up. Criminal law isn’t my strong point, but it’s this particular case about mens rea, and without the actual mens era to take a life, the Charter of Rights & Freedoms doesn’t allow the crown to attach the “stigma of infamy” that comes with a murder conviction.

    Okay….after looking I totally remember this, don’t know why the case name wasn’t on the tips of my fingers.

    It’s R. v. Vaillancourt, [1987] 2 S.C.R. 636, 1987 SCC 78,

    But also see R. v. Martineau [1990] 2 S.C.R. 633.

    Hope that helps! The cases are pretty straightforward constitutional analyses of s7 & then (of course) whether s1 saves the s7 violation. Easy readers. The takeaway, however is incredibly short & sweet:

    One principle of fundamental justice which the crown is unable to violate is the principle that for infamous crimes [so far this only includes murder] the stigma attached to such crimes requires for conviction a guilty mind worthy of such stigma. Therefore, when one accidentally kills in pursuit of an illegal aim, a murder conviction is impossible regardless of statute.

  43. Lyn M: ADM MinTruthiness says

    Yep. I found the case and re-read it and Martineau as well. The section seems to be pretty much dead in the water.

    Of course in the States, constructive murder is alive and well as a concept, but I find it easier to locate actual code sections if I use Canadian codes.

    Thanks for the detailed answer!

  44. says

    My first thought after reading this post was “where did these two go to medical school, watching House, MD?! This really sounds like bad medical TV drama: The “brilliant” doctors have an unorthodox idea how to cure cancer but those silly, rigid-thinking, unimaginative bureaucrats on the IRB stand in their way. Sounds all very “heroic” until you find out they were in danger of being shot by duck hunters (Where’s Dick Cheney when you need him?).

  45. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    Meh. No sweat, Lyn M. Gotta use this brain for something.

    Of course, accidentally causing death can still be manslaughter or negligent homicide. There are affirmative defenses regarding medical consent, but if they don’t apply (we’d need a lot more info on those defenses in California & the facts of the case) then, yeah, there’s still serious criminal liability there, even if constructive murder wasn’t available.

    They certainly had “subjective foresight of death”. It would be an interesting case in Canada. It would actually still be an interesting case in California.

  46. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    OT and BTW:

    damn autocorrect keeps turning “mens rea” into “mens era”. Drives me bonkers, mostly because I don’t always catch it – as I didn’t at least once above. Harrumph.

  47. Lyn M: ADM MinTruthiness says

    I hear you on that! I had a file where an auto correct nearly went out. Deponent appeared to have written, “When I entered the room, the children were sitting on the floor and eating Kentucky Fried Children.” The autocorrect figured usually we wrote children as in Children’s Aid therefore …
    Stopping with the OT.

  48. chrislawson says

    LynM and Crip Dyke: if I like Kentucky Fried Children does that mean I’m living in a mens era?

  49. says

    If you’re a patient approached to take part in a medical trial, what are the things you should be seeing to distinguish a kosher from a bogus trial? Do you typically get told about methodology? How do you know if the experiment has been overseen by a review board? Does the patient advocate speak to you first? Or at all, come to that?

    I’d hope I’d ask some smart questions if I’m not given more of a clue, but if I was ill I might not have enough command of myself not to let a bogus researcher just do what they want.

  50. chrislawson says

    nightshadequeen #13:

    Yeah, “stimulating the immune system” is one of those stupid catchphrases used by people who don’t have a clue what they’re talking about. The basic pathology behind rheumatoid arthritis, rheumatic fever, ulcerative colitis, Crohn’s disease, thyroid disease, and a raft of others is a stimulated immune system.

  51. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    You get told about the method of intervention, but not necessarily the methodology of the study. Typically you would, but if psychological factors are being examined as part of the study, deception is routine…to the point and no farther, of concealing what is necessary to avoid ruining the psych part of the study by making people aware of the psych factors and thus introducing expectancy and other effects.

    Information about methodology can be vague or non-technical in some cases, but is typically there.

    More later, kids need dino books read.

  52. says

    Stimulation of the immune system, or rather, unmasking tumour cells for the immune system, is indeed one of the most promising new approaches to cancer therapy.(There are still problems, we are dealing with evolution after all, but the principle is solid, and it works fantastically well.

    However, to think that giving a patient gramnegative meningoencephalitis and sepsis would magically take the “Nothing to see here” epitopes off solid tumour cells is nothing but exactly that, magical thinking.

  53. notsont says

    How are they not being charged with a criminal offense? This is scary as hell, how can some surgeons just decide to do experiments on people? I was under the impression human experimentation was not legal without first exhausting all other methods of testing first.

  54. didgen says

    Their statements are fabulous examples of misdirection, outright manipulation of facts, and in the case of one of them, a beautiful compilation of “I didn’t know anything about it, they weren’t my patients, I wasn’t even in the OR, it was all HIM, I SWEAR!!!!!!!!!!!”.
    They even seem to be using as a justification of abhorrent, dangerous malpractice, the ongoing research into treatment of intestinal complications of infection with C. difficile, by re-colonizing the gut with intestinal flora. Re-introducing intestinal flora to the intestines, is in no way equivalent to introducing intestinal flora into the brain.
    I worked for years at UCSF, I am so sorry to see the UC system dragged into the mud like this, they do an unbelievably good job, and are very caring people. I never thought anything that I saw was less than professional, and I was working transplant, and frequently helped with the clinical trials.
    The investigative report at that site shows how devious they were, it is clear that they meant to deceive.

  55. Nick Gotts says

    All the really great scientific pronouncements were made after secret work.

    Well quite: would we now be routinely reviving stitched-together corpses with galvanic stimulation if Dr. Frankenstein had had to go through one of these new-fangled “ethics committees”?

  56. Lyn M: ADM MinTruthiness says

    Nick Gotts 66

    Well quite: would we now be routinely reviving stitched-together corpses with galvanic stimulation if Dr. Frankenstein had had to go through one of these new-fangled “ethics committees”?

    Exactly! Not to mention the ancient alien technology permitting us to instantly transport to distant earth-like planets where they haven’t even heard of ethical reviews. I mean, that’s so secret, people think it’s fiction.

  57. davidjanes says

    They didn’t have institutional review and approval of their procedure!

    I am not an expert, but isn’t that a criminal violation, even with patient consent? Or can they hide from the FDA because it all happened in one facility and no state lines were crossed? Right now it sounds to me like they implanted an unapproved biologic without an IND application to cover them.

  58. madscientist says

    Just because the surgeons had shit for brains didn’t give them any excuse to infect their victims. What the hell were they thinking and why did they even think it would work? I hope the relatives get a big payout.

  59. Crip Dyke, Right Reverend Feminist FuckToy of Death & Her Handmaiden says

    @davidjanes

    I have no idea.

    It’s certainly a violation of FDA regs, but a violation of regulation – even a serious one – is not a “criminal violation”. Moreover, hiding from the FDA isn’t hiding from criminal law, since criminal law is largely a creature of the state – in this case California – and not the feds in the US system.

    You seem to be confusing the FDA regulatory powers with the criminal codes. One has nothing to do with the other in law, though in practice FDA regulators may work with prosecutors to provide evidence and make sure that the prosecutor understands that evidence. The FDA may also be granted investigatory jurisdiction over certain crimes related to its area of regulation, but prosecution would still be in the hands of a US Attorney [an employee of the Justice Dept] or a state AG once the investigation phase was over.

    So, again, I don’t know the law regarding experimentation outside of the controls of an IRB, but the FDA has no control over criminal prosecution.

  60. Nerd of Redhead, Dances OM Trolls says

    You seem to be confusing the FDA regulatory powers with the criminal codes.

    Actually there is a huge confusion. This isn’t something that is regulated by the FDA. Only new drugs are regulated. This wasn’t a drug.

  61. Nerd of Redhead, Dances OM Trolls says

    Medical devices are also minimally regulated by the FDA. Treatments like the OP description are not under FDA jurisdiction, but rather the institution where it happened.

  62. says

    Only new drugs are regulated. This wasn’t a drug.

    No, biologicals are also regulated by the FDA, and clearly the FDA considered this treatment to be a biological, hence the statements from its CBER (Center for Biologicals Evaluation & Research) division.

  63. says

    I’ll only disagree that an N of 1 can’t provide useful data.

    If their first patient had been cured — that would have been way more than just an anecdote.

    If their first patient had been cured and their second patient had seen the tumor reduced by 90% — then every oncologist in the country would have glommed onto this.

    The “power” calculation doesn’t need to require a large number. It depends on the result that you get. A small benefit needs a large number of patients in order to ensure you’re not fooling yourself. A large benefit doesn’t necessarily.

    Of course, in this case, the three patients died in less time than the statistical median. So, even absent the violation of institutional review processes, I think we can declare this particular “treatment” a failure. Which, given the huge amounts of woo-believing nutters out there, means that a clinic will be opening in Mexico in 3…2…1…

  64. davidjanes says

    Yes, I think this is definitely is a biological drug, which means that CBER would regulate it and its approval rubric would be the drug one, not the devices, which is why I said IND instead of IDE. I was just wondering if this might weasel out via the interstate exemption the way that compounding pharmacies can avoid FDA oversight if they don’t ship out of state.

    I also wonder if these doctors get NIH funding, because an ethics breach as described is pretty much eternal debarment as I understand it.

  65. David Marjanović says

    Their whole concept is so full of FAIL it’s not even fractally wrong.

    And, “I’m sorry, but” any surgeon who doesn’t understand the science has NO BUSINESS doing experiments. Even on desperate, desperately ill patients.

    *rageflail*

    The one patient (of the three), that actually meaningfully survived the procedure still got a lifespan about 20% shorter than the _median_ without treatment. That is NOT a result to be optimistic about.

    All seconded.

    Oh, clearly you don’t get it. All the really great scientific pronouncements were made after secret work. The scientist could then leap from the shadows and yell, “Eureka!” Which is Greek for “Surprise!”
    It was proving to be really, really hard for CERN, though, so they buried it.

    Day saved.

    Yeah, “stimulating the immune system” is one of those stupid catchphrases used by people who don’t have a clue what they’re talking about. The basic pathology behind rheumatoid arthritis, rheumatic fever, ulcerative colitis, Crohn’s disease, thyroid disease, and a raft of others is a stimulated immune system.

    Worse. You know about the link between chronic inflammation and cancer?

    Stimulating the immune system stimulates cell division.

  66. Thumper; immorally inferior Atheist mate says

    @Funny Diva #19

    And, “I’m sorry, but” any surgeon who doesn’t understand the science has NO BUSINESS doing experiments. Even Especially on desperate, desperately ill patients.

    FTFY.