May 21 2009

Chemical Castration for Autism – The Latest Atrocity

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Comments: 60

Mark and David Geier are a father and son team that have been pushing the claim that autism results from mercury poisoning from vaccines. They have produced a string of junk science, denounced by mainstream scientists for terrible methodology, reasoning, and statistics. They portray themselves as mavericks, but in my opinion they are just terrible and dangerous scientists.

Their latest atrocity raises their medical mischief to new levels.  For several years now they have been pushing their testosterone hypothesis of autism. They claim, in short, that autism is caused by mercury poisoning, primarily from vaccines. Children with autism, especially boys, have high testosterone, which is partly the cause of their symptoms. But also the testosterone binds to mercury, preventing it from being removed from the body by chelating agents.

They have therefore conducted a study with the drug Lupron in addition to chelation. Lupron is a powerful drug that lowers testosterone levels. It is used for rare disorders associated with premature or high testosterone, or to treat prostate cancer in some men. It is also used as a form of chemical castration for sex offenders.

Each component of the Geiers claims are not only not proven, the scientific evidence is against them. It is pretty clear now from multiple studies that there is no association between mercury or vaccines and autism. Autism is not a form of mercury or heavy metal poisoning. Chelation therapy, which itself is risky, is of not benefit in autism. And high testosterone levels do no cause autism.

The scientific community has soundly rejected the Geier’s claims and renounced their practice. Pediatric endocrinologists, autism experts, and neurologists are nothing short of horrified at the abject and dangerous pseudoscience they are inflicting upon their patients.

Now the Geiers are setting up clinics across the country as little franchises to treat as many children as they can with their Lupron and chelation. They also have at least one patent application for their treatment.

Their clinics have all the hallmarks of dangerous quack clinics – their claims are miraculous, they are against mainstream scientific opinion, they dismiss legitimate scientific criticism with conspiracy theories and talk of persecution, and they target a vulnerable population.

Of course, some parents of autistic children are desperate for a treatment that will improve the lives of their children. The Geiers and their accomplices are offering a “miracle cure”, and dismiss criticism with the usual fallacies, claiming they are being picked on because they blew the whistle on vaccines.

It is also not surprising that many parent believe their children are being helped by the Lupron therapy. There are two reasons for this that have nothing to do with the treatment being effective against autism. The first is placebo effect. Children with autism are still undergoing development and they do often improve just as a natural consequence of maturation. Any improvement will be credited to whatever treatment parents are currently giving.

But there is also a huge psychological incentive to perceive an improvement even where one does not exist. The more radical, risky, and expensive a treatment is, the more parents feel the need to justify their decision by perceiving a benefit. Plus parents want their children to improve. I have seen this result in parents (and also patients themselves) reporting a clear improvement when objective measures showed no improvement at all.

The second source of apparent improvement in children treated with Lupron is that Lupron, given at the doses the Geiers are using, which is 10 times the dose used for childhood conditions of excess testosterone, do amount to chemical castration. Testosterone is a masculine hormone that increases energy, aggression, and sexuality.  Castrated males become more docile, calm, and less sexual.

It is therefore no surprise at all that the children treated with Lupron show these exact responses – decreased aggression and sexual behavior, like masturbation. Therefore all the Geiers have demonstrated is that if you chemically castrate young boys they will exhibit the predictable behavior changes of that hormonal change – they will become less aggressive and sexual. This says absolutely nothing about the role of testosterone in autism, nor is it evidence for an effect of Lupron on autism itself. To claim otherwise is rank pseudoscience.

It is also worth pointing out that the anti-vaccine community has exhibited gross hypocrisy when it comes to the Geiers. They decry every trivial connection between researchers, regulators, and industry as a fatal conflict of interest. Yet the Geiers have performed research overseen only by them and their hand-picked colleagues (not true independent oversight), they are setting up franchises to push their treatment before it is vetted scientifically, and they have a patent application for their treatment – all clear and profound conflicts of interest. Yet the anti-vaxxers just love the Geiers, who they see as maverick heroes.

The entire affair is extremely disturbing. In my opinion, the Geiers are pushing an unscientific and unethical treatment on helpless children. Lupron has serious side effects, and can interfere with normal development. There is no independent evidence to show that the treatment is safe and effective, let alone that it has a favorable risk/benefit profile.

Unfortunately, in the current climate and with the health-freedom laws spreading throughout the states, there is little that can be done to stop even grossly substandard care. Apparently, one only needs to make astounding promises and claim to be the victim of persecution in order to be shielded from the standard of care.

__________________

Orac’s take on the issue

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60 responses so far

60 Responses to “Chemical Castration for Autism – The Latest Atrocity”

  1. pendens proditoron 21 May 2009 at 2:33 pm

    There’s controversy over even the chemical castration of convicted pedophiles, but parents can have it done to handicapped minors? How is this legal?

  2. Oracon 21 May 2009 at 3:18 pm

    Unfortunately, this is really old news. I was blogging about this over three years ago, and Kathleen Seidel even before that. It’s just depressing that it took the mainstream media so long to notice. It’s even worse than that, as you’ll see, when I blog about this tomorrow. Wait until you see how the Geiers have abused the IRB process.

    Also note that my contacts tell me that (1) there will be a second article in the Trib tomorrow, this time about Dr. Mayer Eisenstein; and (2) the Trib is sending three reporters to the Chicago quackfest known as AutismOne today, tomorrow, and Saturday, and they will be writing about it in the Sunday Trib. Should be good reading. Or horrifying. Take your pick. I’ve blogged about AutismOne before.

  3. Watcheron 21 May 2009 at 3:54 pm

    Guess they havn’t heard the Estrogen is probably more important in the development of male behaviors than testosterone through conversion by aromatase. Call me crazy, but this seems like a case where they see a correlation and latch onto it. I also find it highly disturbing that they’re able to setup satellite “franchises” using known drugs without proper FDA approval.

    Would a bound Hg atom be detected any differently than normal? What proof do they have that this “therapy” is doing anything they claim which in turn “cures” autism?

  4. tmac57on 21 May 2009 at 6:04 pm

    Yeah, and you can cure ADD by giving your kids Benadryl too.

  5. Spin-gnosiaon 21 May 2009 at 6:05 pm

    The whole autism saga is emblematic of dim-witted Americans, who cannot be saved from themsleves… and are always easy prey for those who either knowingly take advantage… or do so by being profoundly misguided.

    Lupron or leuprolide is a GnRH agonist/analogue which Ob/Gyns like myself have used routine in the treatment of endometriosis… or preop to shrink uterine “fibroids”. Anyway, it initially upregulates… then downregulates gonadatropins… and ultimately estrogen(s) in the female and testosterone in the (unfortunate) males.

    I can’t get too excited by this report since even at this relatively late juncture in human history, despite all the light science has shed on biological processes… there remains a huge chunk of humanity mired in stupid-stitions… keeping charlatans, hucksters, quacks & faith-healers well attended and those bizzaro late-night infomercial rolling… cha-ching!

    I no autism expert… but I have come across convincing articles on the genetic link(s) and neurological deficits (eg, “mirror neuron” deficits)… that go a long way in explaining the “spectrum disorder”. Also, the complete lack of evidence regarding either vaccines or mercury as the etiology has been repeated trumpeted in the mainstream media. Thus, one must be willfully ignorant to sign on their child for such a lame and potentially harmful, completely unproven “treatment”.

    Sooo…. like so many areas in life… ignorance is what ignorance does. I no longer react to such supposed “atrocities” with outrage since I have been on this planet long enough to know that “stupid human tricks”, like the bacteria in our gut, will be with us until extinction.

    Now… where did I put that “prayer cloth” & powerful crystal….

    Cheers.

  6. Oracon 21 May 2009 at 6:37 pm

    The whole autism saga is emblematic of dim-witted Americans, who cannot be saved from themsleves… and are always easy prey for those who either knowingly take advantage… or do so by being profoundly misguided.

    It’s not just Americans. Andrew Wakefield and the antivaccine group JABS, for instance, are British. Vaccination rates are plummeting in Britain and in many nations that make up the E.U. The Swiss, as I recall, recently had a measles outbreak, thanks decreased vaccination rates.

  7. weingon 21 May 2009 at 9:48 pm

    Maybe this is one of nature’s ways of pruning the population.

  8. superdaveon 21 May 2009 at 9:48 pm

    for what it’s worth, a blog post at ageofautism.com also disapproved of the lupron treatment.

    http://www.ageofautism.com/2009/05/autism-and-testosterone.html

  9. HHCon 21 May 2009 at 9:49 pm

    Its a temporary chemical fix unless these scientists are intending
    to create a new age Prader-Willi Syndrome variation of autism. Behavioral programing can be used successfully for inapproprate agression and sexual behaviors. Why are the parents becoming hypervigilent about sex and aggression? It wasn’t long ago in American history that mentally retarded were not allowed to reproduce.

  10. kvsherryon 21 May 2009 at 11:48 pm

    @weing-normally I would agree with you except that the population that is being pruned is full of little kids who are too young to make the decision themselves. Stupid adults deserve what they get, kids of stupid adults deserve to be protected.

  11. [...] Steve Novella goes into length about the Geiers’ claims here. [...]

  12. agashemon 22 May 2009 at 6:18 am

    I need to add, as I feel I always should, that as a mother of a 16 year old girl on the spectrum I would no more follow this treatment than I would many of the others that have been ‘discussed’ with me over the last 16 years, (often these discussions are more like finger pointing and pontificating but never mind) that I love my daughter the way that she is and wouldn’t want her ‘cured’. Neither would she; she is very clear, as is Temple Grandin that her identity is completely staked on being autistic and the way that her brain works. How could/would I change that????? The fear mongering that children are being ‘made’ autistic is so infuriating in that they make it seem that autists need to be eliminated…………….

  13. Steven Novellaon 22 May 2009 at 8:20 am

    Interesting that AgeofAutism ran a scientific article on the issue – although I do not recognize the author as a regular contributor there. Maybe they think this issue is peripheral, or recognize the negative PR potential of chemically castrating children with autism.

    The comments to the article are also telling. While some are supportive, most are like this one:

    “The Geiers must be onto something if they are scaring the Chicago Tribune to write a negative article about them. ”

    Nice confirmation bias. Positive press coverage means the claims are legitimate. Negative press coverage means they are so legitimate they are scary.

    This kind of logic always reminds me of the wonderful line from Full Metal Jacket:

    “Anyone who moves is a VC. Anyone who stands still is a well-disciplined VC.”

  14. daedalus2uon 22 May 2009 at 9:01 am

    I think there is an association of higher testosterone with ASDs, but the androgens don’t “cause” ASDs, the ASD phenotype (acute and chronic) and somewhat elevated androgens are both caused by low NO. In no way, shape or form is there any credibility to what the Geiers are doing.

    I think the only reason the Geiers latched onto testosterone binding mercury is because there was a paper 40 years ago where a testosterone mercury complex was synthesized to do x-ray diffraction on. Those researchers did it because mercury atoms scatter x-rays and so a crystal with a lot of mercury in it is easier to do x-ray diffraction on. It had nothing to do with any great and/or special affinity of testosterone for mercury (testosterone doesn’t have one). It is complete nonsense and shows how little they actually understand about physiology (and their unwillingness to learn). A classic and frightening example of the arrogance of ignorance and what happens when you cherry pick the literature without understanding the actual science. This is what Feynman called cargo cult science, going through the motions but without the intellectual integrity to examine your premises.

    NO is the normal regulatory molecule that regulates the activity of the enzymes that are the rate limiting step in testosterone synthesis. Steroid physiology is quite complicated with multiple substrates being produced and consumed in multiple tissue compartments by multiple enzymes under multiple control schemes. Mostly the effects of steroids are local, that is the signaling effects they have are in the same tissue compartment as they re created. There are some exceptions, where substrates produced in one tissue compartment have effects in other tissue compartments but usually that is due to local production of new active agents. Circulating levels of androgens are not very precise indicators of what is going on in the various tissue compartments. The normal range in blood exceeds an order of magnitude and the normal range for males increases by 2 orders of magnitude during puberty and by about a factor of 5 for females. It would be easy for someone unsophisticated to find an increase that they could delude themselves into thinking was pathological (especially if they made a lot of money by doing so).

    Higher levels of testosterone in autism (and in PCOS) are due to lower levels of nitric oxide. NO is the normal regulator of testosterone synthesis (by inhibiting the cytochrome P450 enzyme that is the rate limiting step in testosterone synthesis). Lower NO causes increased testosterone levels, but that is an effect, not a cause (though there is some positive feedback in that higher testosterone does lower NO levels too). Estrogen increases NO levels. I think this is the reason for the correlation that Simon Baron Cohen has observed in amniotic fluid testosterone levels and sub-clinical autism-like behaviors (he didn’t find autism, just increased levels of behaviors that if they reached higher levels would be diagnostic of autism).

    Stress is a low NO state. There are many stress compensatory pathways that are triggered by low NO. I think high testosterone is one of them. I think that part of the mechanism by which antibiotics in animal feed causes animals to grow faster, mature sooner, become big and more efficiently convert feed into body mass is due to low NO. I think that low NO in farm animals produced by antibiotics is via the same mechanism as I am working with, via the loss of the bacteria that generate it on the external skin.

    In 1850, the average age of menarche was nearly 17. Now it is 12 or even less. I think he gradual reduction in the age of puberty is not only due to diet but due in part to the loss of the bacteria that are the subject of my research. One of the major effects of high testosterone is to cause the growth of hair. I see this as a feedback mechanism to increase NO/NOx levels by expanding the niche for the bacteria I am working with, more hair means a larger niche for the ammonia oxidizing bacteria, so they make more NO/NOx.

    I never liked SBC’s depiction as autism as an extreme male brain. I think a better depiction would be an extremely stressed brain. I see ASDs as what occur when the brain develops under conditions of “stress”, and I see it as good regulation around a bad setpoint. I think (and I believe the anecdotes bear this out) that children with autism do best when they are under less stress, when they are not bullied, when they are nurtured, when they are allowed to just be children and develop at their own pace. But that is true of all children, and of all people too.

  15. superdaveon 22 May 2009 at 9:45 am

    the cognitive dissonance on display at AoA over this issue is dizzying.

  16. Calli Arcaleon 22 May 2009 at 9:49 am

    I think (and I believe the anecdotes bear this out) that children with autism do best when they are under less stress, when they are not bullied, when they are nurtured, when they are allowed to just be children and develop at their own pace. But that is true of all children, and of all people too.

    Indeed. This is what makes it so depressing to read about the behavioral interventions that some people use with autistic children. They often involve greater punishment, because the caregivers have the false impression that the child is ignoring them and that sterner punishment is needed in order to “get through to” the child. One example I’ve heard of several times is locking the child into a small dark closet as punishment. It doesn’t work, and in fact it makes the situation worse.

    I think a lot of caregivers (parents and teachers alike) forget sometimes that they are dealing with children, not miniature adults. This probably confuses a lot of the ones dealing with autism, since an autistic child sometimes appears mature beyond their years, and their misbehavior can seem malicious at times even when it isn’t. The trick is to not take it personally.

  17. Watcheron 22 May 2009 at 10:57 am

    D2U, how does NO effect aromatase behavior? It seems like whenever there’s a buildup of T, the reason can be from a faulty aromatase gene. (Although over production is a reasonable cause too :) ) It could be an important aspect of this idea that NO, T, and E are at least somewhat responsible for autistic behavior.

  18. HHCon 22 May 2009 at 2:01 pm

    How and when are private physicians to use IRBs? They obviously aren’t affiliated with universities or hospitals that supervise their research interests.

  19. daedalus2uon 22 May 2009 at 3:28 pm

    HHC, if you are going to do research you have to have an IRB. That is an absolute requirement of the Declaration of Helsinki.

    http://www.wma.net/e/policy/b3.htm

    What the Geiers are doing fails to meet the standards of the Declaration of Helsinki on multple levels.

  20. daedalus2uon 22 May 2009 at 3:51 pm

    There are a lot of enzymes involved in steroid synthesis, not just aromatase.

    Humans have genes for 59 cytochrome P450 enzymes. Most of them do multiple things and there are significant polymorphisms. Many of them make products that are substrates for other enzymes with significant cross-talk between them. This makes for some redundancy and a lot more complexity.

    Essentially all of the cytochrome P450 enzymes are regulated by NO; that is NO binds to the heme that activates O2 and inhibits enzymatic activity. Most of the cytochrome P450 enzymes associate with membranes and are found in mitochondria or microsomes. Most of these enzymes are quite uncoupled, that is they generate significant superoxide as they cycle, for some as much as 50% of the O2 reduced by the enzyme goes into making superoxide. Virtually all of this superoxide is vectorally transferred to the inside of the vesicle the P450 enzyme is incorporated into, and there is SOD and catalase on the inside of the vesicle, first to dismutate the superoxide to H2O2 and then to convert the H2O2 to O2.

    I think this superoxide is a “feature” to pull down the local NO level and disinhibit the cytochrome P450 and accelerate it metabolism of its substrate, either a normal physiological substrate or a xenobiotic.

    NO also reduces the expression of aromatase so more NO both reduces the amount of aromatase and the activity of the aromatase that is present. This regulation is likely quite complex and different in different tissue compartments and likely different at different life stages.

    http://molehr.oxfordjournals.org/cgi/content/abstract/5/5/396

    The mechanisms of why “excess” testosterone builds up are mostly unknown. In women, a common cause of infertility is hyperandrogenic anovulatory syndrome, and also polycystic ovarian syndrome. Both of these are characterized by high androgen levels and by the symptoms of high androgens, male pattern baldness and hirsuteness.

    I think that some of these are adaptive stress mechanisms that have been driven too far, into a pathological parameter space due to a non-physiologic low NO level. For example, if you are a woman under a lot of stress because you are living in a war zone, reduced fertility would be a “feature”. Living in a war zone is not a good time to become pregnant. I think high stress causes low NO which reduces fertility to put off pregnancy until when the environment improves. There are multiple mechanisms by which low NO does this, not just via higher androgen levels.

    If you are living in a war zone, at times it is better to be hypervigilant and escalate to violence on a hair-trigger. When steroids cause this type of behavioral modification it is called “roid-rage”. Rapid escalation to violence might be an appropriate response; it is a high risk/ high reward response. Escalating to violence first might save your life 8 out of 10 times, but it might cost it 19 out of 100 times if you were otherwise not going to be attacked. Remaining peaceful in non-violent times might avoid violence 99 out of 100 times. Under peaceful times, when you don’t need to fight, you don’t “need” the large muscle mass that high levels of androgens provide. Those resources might better be put to reproduction. Lower androgen levels likely reduce the incidence of cancer, heart disease and other things. Future ill health might be a good trade-off for immediate survival in a war zone.

    Stress responses are always complex. Organisms need to do multiple things on multiple different timescales to optimize their survival and reproduction under conditions that cause stress. All responses are always trade-offs with positive and negative aspects. What might be advantageous under one set of circumstances might be disadvantageous under others.

  21. artfulDon 22 May 2009 at 3:53 pm

    “if you are going to do research you have to have an IRB. That is an absolute requirement of the Declaration of Helsinki.”

    That’s an extremely misleading citation.

    What’s more to the point would be whether the research conforms to the exempton requirements.

    http://en.wikipedia.org/wiki/Institutional_review_board#Exemptions

  22. sowellfanon 22 May 2009 at 3:57 pm

    Well, the article in today’s Chicago Tribune was terrific – perhaps even better than yesterday’s article. Regarding the fact that the reporters are going to the AutismOne expo to check that crap out, I just wanna say, “My nipples explode with delight!!”. From the quality of the four articles written so far, I have really high expectations for what I read on Sunday.

  23. sowellfanon 22 May 2009 at 4:07 pm

    Question about posts by Daedalus2u:

    Are his posts that constantly talk about ‘NO this’ and ‘NO that’ just complicated science that’s above my head (since I don’t have a microbiology background *at all*), or are they more along the lines of nutty ravings of someone who’s really obsessed with a certain idea (that is, as quoted from Daedalus2u’s profile “…repairing the deficient nitric oxide physiology that most individuals have.”)?? I’ve seen him post over at sciencebasedmedicine.org, I believe – and now here – and it seems like he’s mostly ignored, and sometimes argued with – so I guess I just wanted to know for the record.

  24. daedalus2uon 22 May 2009 at 4:31 pm

    As I read the Declaration of Helsinki, for medical research, an IRB (or functional equivalent) is required.

    “15. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.”

    The exceptions you cited allowed for under US law appear to me to be for “research” that is non-medical.

  25. artfulDon 22 May 2009 at 4:54 pm

    “Functional equivalent” is not exactly the same as absolute requirement now is it. And read the exemptions again and note that much of the research referenced has direct application to the practice of medicine.

  26. Watcheron 22 May 2009 at 5:14 pm

    There are a lot of enzymes involved in steroid synthesis, not just aromatase.

    Never said there was, just pointing out a similarity between your own argument and what is already know about aromatase. Knocking out aromatase is known to cause an increase in T, as well as behavioral abnormalities in males.

  27. daedalus2uon 22 May 2009 at 5:42 pm

    Yes “functional equivalent” is exactly the same as an absolute requirement. It doesn’t matter what an IRB is called. In non-English speaking regions they will call it something else. The functional equivalent is required.

    The requirements of the Declaration of Helsinki are more stringent that the requirements under US law for an IRB because the Declaration of Helsinki specifically says so.

    “…these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. “

  28. artfulDon 22 May 2009 at 6:07 pm

    How ridiculous can you get (says I rhetorically). IRB sets out US legal requirements. Helsinki does not. And where are the Helsinki equivalents to the IRB exemptions (again in the rhetorical mode).

  29. daedalus2uon 22 May 2009 at 8:09 pm

    AD, Helsinki doesn’t have exceptions. The context of the question was how does a physician do who is not affiliated with an institution do research. The answer is without an IRB or equivalent, a physician can’t do medical research while continuing to act as a physician bound by physician ethics. Helsinki says that the research has to have certain characteristics, not just how it has to be carried out. The Geiers constituted a faux IRB filled with their cronies and puppets. In no way, shape or form does what the Geiers did constitute either a valid IRB, or consistent with the Declaration of Helsinki.

    The Geiers are operating their IRB the way they do their “science”. They go through the motions and manipulate the process until it produces the “answer” they want to get. The ethical outcome they get is the same as their scientific outcome, complete nonsense.

    sowellfan, there is only one way to find out if what I post is nutty ravings or sufficiently advanced that it is indistinguishable from magic, and that is to understand the science for yourself. I appreciate that is not an easy thing to do (perhaps better than anyone else), but in science understanding something can’t be delegated.

  30. artfulDon 22 May 2009 at 8:38 pm

    d2u: The context of the question was set by this comment from Orac: “Wait until you see how the Geiers have abused the IRB process.”

    Clearly a reference to a process where they had hoped to find an advantage in its exemptions. But you, as usual, missed the point at the crux of the question.

  31. mike stantonon 23 May 2009 at 3:51 am

    Steve,
    the AoA article that questions the Geiers’ use of Lupron is written by a rival quack, Lorene Amet, who runs a clinic in the UK that does not offer Lupron. She manages to be right about the Geiers and wrong about most everything else.

    ArtfulID,
    It is worse than you think. The Geiers did not seek exemption from the IRB process. They set up a fake IRB that included members of the Geier family, their business associates and the parent of one of the children they were “treating.” Kathleen Seidel exposed them in her blog post An Elusive Institute three years ago.

  32. artfulDon 23 May 2009 at 4:37 am

    Boy, they’re going to get really mad over there in Helsinki. But seriously, what can be done other than shutting them down? Can they not go after them for fraud under the circumstances?

  33. Steven Novellaon 23 May 2009 at 7:27 am

    Previous efforts to shut them down have failed. It is very difficult to go after popular quacks. That does not mean there won’t be future efforts.

    Regarding IRB – just to be clear, there are specific US regulations that are more detailed than the Helsinki requirements. In my opinion, the Geiers violated the letter and spirit of the IRB requirements. There are rules as to the makeup of IRBs, and I cannot see how their IRB met those requirements.

    The problem is that the policing of IRB has been left mostly to institutions, with occasional spot checks. The Geiers bypassed that system by making their own IRB rather than going through a university. They opened themselves up to liability (without the cover of a university), but apparently are willing to take that chance. Unfortunately, they may have calculated correctly.

  34. Oracon 23 May 2009 at 10:21 am

    “Functional equivalent” is not exactly the same as absolute requirement now is it. And read the exemptions again and note that much of the research referenced has direct application to the practice of medicine.

    Take it from someone who does clinical research, the Geiers’ research most definitely does not–I repeat, not–qualify for an exemption from the IRB requirement. Period. It is not even a close question. I wrote about this three years ago:

    http://scienceblogs.com/insolence/2006/06/antivaccination_warriors_vs_re.php

    Moreover, “exempt” research must still be evaluated through an expedited review process by an IRB or the chair of the IRB to determine whether it is, in fact, exempt. But wait! The chair of the Geiers’ IRB is…Mark Geier! Holy conflict of interest, Batman!

  35. Rachael Dunlopon 23 May 2009 at 12:17 pm

    Can anyone provide a link to the Tribune stories? Would like to read them.

  36. Steve Pageon 23 May 2009 at 12:52 pm

    And high testosterone levels do no cause autism.

    Just for the sake of clarity, Simon Baron-Cohen and colleagues have been arguing that prenatal exposure to testosterone may be a factor in the development of autism. Auyeung et al (2009) published a follow-up paper on it earlier this year. http://www.autismresearchcentre.com/docs/papers/2009_Auyeung_etal_BJP.pdf

    I know that that’s not what the Geiers are claiming, and I don’t want to be seen to be giving legitimacy to their wacky ideas. I just thought that it was worth clarifying before someone takes that line out of context and uses it against you, Steve.

  37. artfulDon 23 May 2009 at 2:40 pm

    d2u writes: “The exceptions you cited allowed for under US law appear to me to be for “research” that is non-medical.”

    I reply: ” – read the exemptions again and note that much of the research referenced has direct application to the practice of medicine.”

    Orac: “Take it from someone who does clinical research, the Geiers’ research most definitely does not–I repeat, not–qualify for an exemption from the IRB requirement. Period. It is not even a close question.”

    Holy non-sequitur, Orac. The point was that d2u was denying the exemptions applied to medical research and I was saying they did.
    The fact that the Geiers’ stuff doesn’t qualify for an exemption is interesting but that would be because it is bad medicine, not because it’s claiming to be non-medicine.
    But thanks for the inadvertent confirmation that the exemptions do apply to medical practice. Not even a close question indeed.

  38. daedalus2uon 23 May 2009 at 4:17 pm

    AD, you are the one with the non-sequitur. The post was about experimental medical treatments. A question was asked how does a private physician go about doing medical research without an institution to constitute an IRB. The simple answer is they don’t.

    If you look at the “exemptions” for IRBs, none of them involve taking specimens, measuring clinical parameters, or administering drugs. The exemptions cover “research” including things like market research, things which have no medical component at all. Market research as to which type of fizzy sugar water people prefer is a type of “research”, and so it would be covered by the US requirements for institutional review boards if there were not an exemption for it. Research on which fizzy sugar water people prefer is not “medical research”.

    The Declaration of Helsinki addresses multiple aspects of medical research on humans, not just the informed consent aspects. The Declaration of Helsinki requires that medical research conform to scientific principles. The lupron protocol does not have a scientific basis and so fails to even be worthy of being brought to an IRB.

    Kathleen Seidel over at Neurodiversity did an excellent job of exposing the faux IRB that the Geiers used. She sent that information to a journal that had a write-up by the Geiers on their “research” pointing that out, and the journal retracted the paper (very likely because it didn’t conform to ethical standards but they didn’t say why). If you want the full background on the use of lupron to treat children with autism this is the place to go.

    http://neurodiversity.com/weblog/article/109/

    There has been a lot about this out in the blogosphere. It is good that MSM is picking up on it, but they could have done so years ago, maybe then these children would not have been subjected to these brutal and useless treatments.

  39. artfulDon 23 May 2009 at 4:54 pm

    d2u, too bad you didn’t give your so-called simple answer to begin with, rather than give an historical account of the genesis of the IRB with none of the particulars as they apply to the US versions. The Geiers got a faux IRB here, not in Helsinki. Any sanctions will be applied here. Helsinki has none to apply. Your making an issue of whether exemptions apply is a red herring – the subject was only brought up with respect to the sanctions that may apply here since none are applied from Helsinki.
    You’re good at rattling off details, but really bad at connecting the dots that give any meaning or significance to the picture.

  40. sowellfanon 23 May 2009 at 6:12 pm

    Rachel Dunlop: Here are the links to the four stories that the Chicago Tribune has published so far. I believe there’s going to be another on 5-24-09 about the AutismOne convention.

    http://www.chicagotribune.com/health/chi-autism-lupron-may21,0,242705.story

    http://www.chicagotribune.com/health/chi-autism-lupron-geiers-may21,0,983359.story

    http://www.chicagotribune.com/news/local/chi-autism-doctor-eisenstein-may22,0,3826791.story

    http://www.chicagotribune.com/news/local/chi-autism-doctor-rosimay22,0,5086891.story

    Also, there’s a graphic that is linked separately

    http://www.chicagotribune.com/health/chi-autism-pdf-link,0,294415.storylink

  41. Watcheron 23 May 2009 at 7:00 pm

    @steve page

    Not to be a broken record, but I still don’t think you can look at just testosterone given the interplay because of aromatase, especially in the prenatal brain, that exists between Testosterone and Estrogen.

  42. AnneBon 23 May 2009 at 11:34 pm

    Spin-gnosia: Give us dim-witted patients a break. We’re supposed to be protected from incompetent or unethical doctors. That’s what medical licensing boards are for. Doctors are a self-policing profession, so instead of calling credulous parents stupid-stitious, why not go police Geier’s ass off instead? Just saying.

  43. daedalus2uon 24 May 2009 at 10:24 am

    AD, there are plenty of non-US readers of this blog. The declaration of Helsinki doesn’t have the “force of law” anywhere, not in the US, not in Helsinki either. It is what medical professionals and stake-holders (world wide) have collectively decided is the only ethically appropriate way that medical research can be performed.

    Like all ethical guidelines, they are only binding on those who choose to act ethically. It is much like the law, an honest person doesn’t need laws to behave honestly and a dishonest person isn’t going to follow the law anyway.

    An ethical person wants to behave ethically, and uses ethical guidelines simply to inform themselves what ethical behavior is so that they can behave ethically without figuring out the ethical trade-offs themselves. The unethical person tries to “game” the ethical guidelines so they can do what they want. That is the same as the dishonest person trying to “game” the legal system.

    Gaming the system is what the Geiers have done (and done poorly). It is just like doing cargo cult science, which is trying to “game” the scientific method. Trying to “game” the scientific method will fail. That is what peer reviewers are supposed to catch, researchers trying to game the scientific method.

    Sorry I haven’t included enough details for you to connect the dots and fill in the rest. That is really hard to do in brief comments.

  44. artfulDon 24 May 2009 at 1:41 pm

    d2u, when have you ever made a brief comment? Your problem isn’t with giving enough details, its with the great flow of details that have nothing to do with the the question.

    Example: Here you give us a nice lecture about ethics which of course we already knew was the failing here. Then you compare that failing with cargo cult science, which again throws out dots irrelevant to even your own superfluous discourse.

    Cargo cult scientists conduct flawed research that fails to produce useful results. Ethics and fraud were not the hallmarks of that failing.

    Think NO.

  45. Oracon 24 May 2009 at 2:36 pm

    IRB sets out US legal requirements.

    Actually, no.

    The Common Rule sets out the legal requirements in the U.S.

  46. Oracon 24 May 2009 at 2:43 pm

    The point was that d2u was denying the exemptions applied to medical research and I was saying they did.
    The fact that the Geiers’ stuff doesn’t qualify for an exemption is interesting but that would be because it is bad medicine, not because it’s claiming to be non-medicine.
    But thanks for the inadvertent confirmation that the exemptions do apply to medical practice. Not even a close question indeed.

    Not exactly. “Exempt” research does not mean that it’s exempt from oversight. The term “exempt” means only that the research is exempt from requiring full review and monitoring by the entire IRB. Moreover, it is usually the IRB that determines whether research is exempt or not, and the IRB can change its ruling if circumstances change.

  47. artfulDon 24 May 2009 at 3:15 pm

    Orac, the common rule is from the US code of Federal regulations, not from Helsinki. So these ARE US legal requirements, which was the point, quibble as you seem wont to do about the syntax.

    And nobody even implied that exempt research was exempt from oversight. But thanks again for confirming the exemptions do apply to medical practice. Which was what d2u had said was not the case.

  48. HHCon 24 May 2009 at 3:58 pm

    daedalus2u, Thank you for your fruitful discussion of IRBs and the background source for information on current federal law. I appreciated your link. Also, read your current post on your blogspot. Nice work:-)

  49. HHCon 24 May 2009 at 4:17 pm

    By the way, I didn’t see a story on the convention in Sunday’s May 24 Chicago Tribune.

  50. daedalus2uon 24 May 2009 at 4:59 pm

    AD, they are both examples of going through the motions without understanding the underlying motivations for doing those things in that particular way. They are both signs of an inability to consider that the reality of the situation is unknown and is more complex than the model that the heuristic is designed to fit. This is the type of behavior that the arrogance of ignorance fosters, where people don’t know the extent of their ignorance and assume there is nothing important that they are ignorant of.

    I see this type of behavior as characteristic of a top-down hierarchy. Those at the top make the rules which those at the bottom must follow (even if they are wrong).

    For example, hitting a person in the chest is bad and unethical, unless the person is having a heart attack when hitting them in the chest might cause their heart to start beating correctly and is good. Complex medical situations are complex and entail complex ethics, and so they require complex processes to address. Hitting a person in the chest doesn’t become ethical because you got someone to lie and say they were having a heart attack or because you use bogus definitions and tests to declare that they are having a heart attack. Giving Lupron to children doesn’t become ethical because you have done a zillion tests and one of them was out of range.

    All true health care professionals know that all tests are subject to error and at best are only a snap-shot of what was going on when the test was taken (yes, I am using the term true health care professional because attention to the actual details is an important part of being a true health care professional. Quacks like the Geiers are not true health care professionals).

    The failing wasn’t just in not following the “rules” of the IRB process; the failing was to not have as a goal that the process be ethical. The failings were much more severe than just not following the IRB rules.

    In cargo cults, the leader says, follow these rules which I have copied from the westerners and cargo will appear. In the Geier IRB, the leader says “follow these rules and an ethical result will happen”. An ethical process, like a scientific process isn’t something you can add at the end by sprinkling on some “ethics stuff”. A process is only ethical if each step is ethical. It is the process that matters, not the end result.

    The anti-vaccine quacks don’t care about ethics or about science. If they did care they would use different processes to do what they are doing. This is one of the problems with EBM. The process is important. You can’t string a limited number of facts together and end up with a scientific process. EBM ignores prior plausibility which is nonsensical. EBM can be practiced in a cargo cult manner. That is how virtually all of the CAM studies are done. If there is no a priori scientific plausibility for an intervention, it is not ethical to test it on humans.

  51. artfulDon 24 May 2009 at 6:19 pm

    d2u, I repeat, cargo cult scientists conduct flawed research that fails to produce useful results. Ethics and fraud were not the hallmarks of that failing.
    I seriously doubt that the Geiers ever believed that if anyone followed their rules, an ethical result would happen, since they knew the means to that end were in themselves unethical.
    Considering that your own research has so far failed to produce useful results, does that make you a cargo cult scientist? And is that failure in any way due to ethical considerations? Would you succeed if you put ethics aside, as the Geiers have done?

    And yet off you go on some rant about top down hierarchy which has little or nothing to do with the question at hand. Would that it did and the situation might have been different.

  52. HHCon 24 May 2009 at 7:33 pm

    The authority for IRB is 5 United States Code 301 and 42 United States Code 289(a). Reference is the Code of Federal Regulations, Title 45, Protection of Human Subjects, Part 46- Office for Human Research Protections.

  53. artfulDon 24 May 2009 at 8:06 pm

    Yeah, that’s where you find the Common Rule alright. You betcha. Keep up the good work.

  54. [...] However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.” [...]

  55. daedalus2uon 25 May 2009 at 8:51 am

    AD, cargo cult science is about the process, not the result. It is about a process that is intellectually dishonest. One can do intellectually honest science that is rigorous and correct and not interesting or useful.

    I disagree with your assessment that my research has not produced useful results. That you say that makes it clear that you haven’t read or understood enough of it to make that assessment. It certainly has improved my health, and I consider that to be useful. It has opened up useful avenues of research that had been previously ignored. Perhaps ethical considerations have slowed my progress, but not following an ethical process is not something I will do.

    What has slowed it the most is people not thinking clearly, rigorously and logically. There is a lot of wrong stuff in the literature, ideas that have become accepted not because of facts and logic but because they seem intuitive even though they are wrong. People anthropomorphize reality because they can only think about reality in anthropomorphic terms. Often correct descriptions of reality do not correspond to anthropomorphic metaphors, but people have a great deal of difficulty in thinking beyond those anthropomorphic terms.

    I think the latching onto a poor but anthropomorphic representation of reality is due to the limitations that some people have in thinking. They use anthropomorphic representations by their “theory of mind” (to use a term I discuss in my blog) rather than more precise representations because there are plenty of neural structures to do anthropomorphic-type thinking. That is how humans communicate. Anthropomorphic thinking comes very naturally and very easily, even when it is wrong.

    One of the major wrong ideas that is slowing progress is the wrong idea of homeostasis. I have a write-up of that. Explaining how homeostasis is a wrong idea is a useful result of my research.

    http://daedalus2u.blogspot.com/2008/01/myth-of-homeostasis-implications-for.html

    I am proceeding as fast as I can given the constraints I have to work under, the resources I have available and my abilities. It does cause me considerable angst that people don’t have the opportunity to improve their health by raising their NO levels by using my technique. I am doing everything within my power to try and make that happen which assuages my guilt at not being successful yet.

  56. artfulDon 25 May 2009 at 11:42 am

    Regarding Theory of Mind, you might want to read what this guy has to say about what you have to say:
    http://iautistic.com/autism-myths-theory-of-mind.php

  57. daedalus2uon 25 May 2009 at 5:58 pm

    I couldn’t find any reference to my conceptualization of theory of mind or any discussion of it and I had a hard time following his.

  58. artfulDon 25 May 2009 at 6:52 pm

    The heading on the page is:
    Autism Aspergers Myths – The Theory of Mind

    The author is Eric Chen, from Singapore, with a diagnosis of Autism Spectrum Disorder, and he wrote a book about his own journey of self-improvement. Who else should you listen to, and offer a modicum of trust that they understand the subject, if not someone like him?
    I won’t quote anything he said here, but if you had a hard time following it, you should try going over some of it again.
    But if you’re happy with your present concepts – your present “theory of mind”- and are convinced you have nothing to learn from this man’s experiences, then leave it be.

  59. [...] Sweet merciful crap. [...]

  60. HHCon 31 May 2009 at 7:00 pm

    skeptigirl, Merci beaucoup pour l’charte canadienne des droits pour les personnes ayant L’autisme. C’est inspire par les documents presente sur le 10 mai 1992 et le mai 1996.

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