I've said it before, and I'll say it again. J.B. Handley, that bull-in-a-china-shop general in the mercury militia who detests me intensely, is about as ignorant as they come when it comes to science and clinical trials. Yesterday, he provided yet more evidence of his cluelessness in his latest piece posted to that repository for all things antivaccine, Age of Autism.
Mr. Handley's all in a lather because the Associate Press published a story yesterday about a proposed NIH-sponsored clinical trial of chelation therapy for autism entitled Fringe autism treatment could get federal study. Because the AP story actually got it (mostly) right, Mr. Handley was sufficiently enraged to be moved to write an open letter to Carla Johnson, the AP reporter who wrote the story. It's the usual assortment of faux wounded self-righteousness that we've come to expect from Mr. Handley, and I won't dwell on this aspect of Handley's rant. That's just his usual schtick. What caught my attention was this passage referring to the proposed NIH study described in the AP article:
Do you really think the NIH fund studies because parents are desperate? No, they fund studies because compelling anecdotal evidence leads them to believe that more work should be done to see if the anecdotes can be extrapolated to a broader conclusion to benefit more kids. This is how science progresses.
My irony meter fried every single circuit in response to seeing Mr. Handley pontificate on "how science progresses." (I seem to go through a lot of them whenever I dare to load my browser with the morass of logical fallacies and bad science that is AoA.) If Mr. Handley had a single clue about how science progresses, he would have realized three years ago that science has left his pet belief that it's somehow, some way got to be the vaccines causing autism behind and has moved on to more fruitful avenues of investigation. Indeed, the only thing keeping the vaccine/autism myth alive is the lobbying of true believers like Handley. It's certainly not scientists. Handley's also being either incredibly naïve, disingenuous, or ignorant. (Take your pick.) The reason is that the NIH is almost certainly not considering funding this study because of "compelling anecdotal evidence" supporting chelation therapy. That's because there is none. It's almost certainly funding this study precisely because Handley's "desperate parents" have become loud and vocal, resulting in political pressure being applied.
Sadly, although I wish it weren't the case, because NIH is funded by the federal government, it can be coopted by powerful woo-friendly legislators, like the antivaccinationist- and quackery-friendly Representative Dan Burton (R-IN). Indeed, I had thought that this particular monstrosity of a study had been killed off once and for all about a year ago. I guess that, like so many studies of "alternative" methodologies, it's a zombie study. Kill it, and it rises from the grave to eat you. Of course, in a democracy, because the NIH is funded by our tax dollars, it needs to be accountable to the voters through the legislature for how it spends its research dollars. The upside of this is that the research priorities of the NIH will usually mirror the priorities of the electorate, for the most part. The downside of this is that political pressure from small, vocal, activist fringe groups can influence the NIH to undertake research and studies whose scientific basis is, to put it kindly, not up to the usual high quality that most NIH study sections demand of NIH-funded research. Some of these studies are even sometimes downright unethical.
My guess is that the genesis of this particular highly unethical and scientifically dubious trial was very similar to that of another much larger and similarly highly unethical and scientifically dubious trial a a few years ago: just that sort of political pressure. I'm referring to the infamous Trial to Assess Chelation Therapy (TACT) for coronary artery disease (CAD). That massive boondoggle came about through in spite of its initial rejection by scientific board reviewing it, which quite correctly pointed out that there was insufficient preclinical data and no compelling scientific rationale to think that the trial would be positive, particularly in light of several randomized clinical trials in the 1990s that failed to find an therapeutic effect against cardiovascular diseaes above placebo attributable to chelation therapy. Thanks to Dan Burton, however, this trial also rose from the dead to suck the blood of American taxpayers to the tune of $30 million, an incredible sum of money for bad science and an unethical clinical trial. (I know, I know. I'm mixing my zombie and vampire metaphors. Just go with it; I'm on a roll.) Indeed, the TACT trial is not the only previous large clinical trial to have come about thanks to woo-friends in high places. There was also the infamous and even more scientifically dubious trial of the Gonzalez therapy, which involves a panoply of woo that includes dozens of supplements a day, a special diet, and coffee enemas, for pancreatic cancer.
So the answer is, sadly, that political pressure from the woo brigade can result in the NIH acting contrary to good science and even medical ethics to fund scientifically dubious studies if enough people (or, more importantly, enough of the right people) apply pressure or threaten its budget. It's exactly the sort of pressure that was applied in the early 1990s by Senator Tom Harkin (D-IA) to "persuade" the NIH to start the embryonic Office of Unconventional Medicine when the scientific leadership saw no reason why there needed to be a separate office to fund such research. Harkin then helped nurse its development into the current $120+ million a year money pit for bad science that has become the NIH National Center for Complementary and Alternative Medicine (NCCAM). Clearly, Ms. Johnson understood that this study is driven far more by politics than scientific merit, as she AP storygets it correct right from the beginning:
Pressured by desperate parents, government researchers are pushing to test an unproven treatment on autistic children, a move some scientists see as an unethical experiment in voodoo medicine.
Unethical voodoo medicine is a beautiful term to describe this study, for reasons I'll explain in a moment.
The treatment removes heavy metals from the body and is based on the fringe theory that mercury in vaccines triggers autism -- a theory never proved and rejected by mainstream science. Mercury hasn't been in childhood vaccines since 2001, except for certain flu shots.
But many parents of autistic children are believers, and the head of the National Institute of Mental Health supports testing it on children provided the tests are safe.
"So many moms have said, `It's saved my kids,'" institute director Dr. Thomas Insel said.
For now, the proposed study, not widely known outside the community of autism research and advocacy groups, has been put on hold because of safety concerns, Insel told The Associated Press.
As well it should be put on hold. In any case, this is sad to see. Dr. Insel apparently doesn't quite understand the difference between testimonials and real anecdotal evidence with clinical observations that are as objective as possible. In fact, it disturbs me greatly that anyone who would say something so utterly boneheaded is actually the head of a major NIH institute.
But, why, you ask, do I call this study unethical? It should be very obvious. One cardinal rule of human subjects research enshrined in the Common Rule, which governs all federally funded human subjects research, is that vulnerable populations must be protected by an additional level of ethical constraints. Usual vulnerable populations include prisoners, the mentally disabled, or--yes--children. The reason, of course, is that prisoners can be coerced, that the mentally disabled may have impaired decision-making capabilities that interfere with their ability to give informed consent, and that children cannot under law give informed consent What all this means is that, both ethically and legally, the bar is set much higher for any human subjects research that is to be carried out on children, and it's hard to imagine a population more vulnerable and needing such protection than autistic children. The science must be even more compelling than for adults, and the experimental design must be bulletproof. Reading the article and from what I know from some of my colleagues, my guess is that the Institutional Review Board (IRB) reviewing the proposed chelation study is having some serious reservations about the safety and risk-benefit ratio of the proposed study.
As well it should.
Normally, at most institutions, any clinical trial protocol that is submitted for approval usually goes through two committees, a Scientific Review Board (SRB) and the IRB. The SRB is generally charged with evaluating the study for soundness of its scientific rationale, how compelling the evidence supporting the hypothesis to be tested is, how well the clinical trial is designed, and how rigorous the proposed statistical analysis is, as well as whether the investigator proposing it has the skills to carry it out well. If any of these aspects of the trial is dinged by the SRB, the trial won't even make it to the IRB, which is charged with making sure that the human subjects are protected and that the trial design is ethical. Again, when the subjects are children, the IRB is supposed to be utterly ruthless in quashing any potential problem with patient safety.
So why is this trial so bogus? It's bogus to its very core because its very core, the hypothesis that it is designed to test, is not supported by good science. That hypothesis is that autism is in fact a form of mercury poisoning is the basic hypothesis being tested here, with the corollary being that chelation can remove that excess mercury and alleviate the symptoms of autism. Neither the main hypothesis, nor its corollary is supported by compelling evidence. Indeed, it doesn't even have biological plausibility going for it, as it in essence postulates that some sort of mercury exposure (from those evil vaccines, naturally) caused some sort of brain damage in infants that led to autism months to years later. Even if mercury in vaccines did cause damage leading to autism, that such damage could be reversed months or even several years later by chelation defies scientific plausibility based just on biology alone.
But it's more than just scientific plausibility. In any normal trial, especially on children, there has to be good preclinical evidence supporting the hypothesis. There should, for instance, be animal models showing that mercury exposure does indeed cause autistic symptoms and that chelation therapy alleviates those symptoms. There should be cell culture and animal models showing a plausible physiological mechanism. (Throwing a bunch of thimerosal on neurons in cell culture then noting that some of them die doesn't count. I could do that with bleach, but that wouldn't prove that bleach causes autism.) Absent strong animal data, there should be high quality observational data in humans that support the hypothesis; for example, compelling, strong, and consistent evidence that autistic children do have higher mercury exposures and higher mercury levels indicative of chronic mercury poisoning. There are no such data, and the usual data presented as "evidence" that mercury poisoning causes autism is of such poor quality that they don't deserve to be called "data." Most of all, however, the drug to be used, DMSA, is not risk-free:
But the study was put on hold for safety concerns after an animal study, published last year, linked DMSA to lasting brain problems in rats. It remains under review, Insel told the AP.
I believe the article is referring to this study, which shows that DMSA can indeed alleviate the cognitive effects due to acute lead toxicity in rats. However, treating rats not poisoned with lead actually hurt them, producing cognitive effects as similar to those caused by higher levels of led exposure, suggesting that giving DMSA to children who do not actually have lead poisoning is likely to be a very bad idea. Indeed, the abstract concluded:
These are the first data, to our knowledge, to show that treatment with any chelating agent can alleviate cognitive deficits due to Pb exposure. These findings suggest that it may be possible to identify a succimer treatment protocol that improves cognitive outcomes in Pb-exposed children. However, they also suggest that succimer treatment should be strongly discouraged for children who do not have elevated tissue levels of Pb or other heavy metals.
So let's see. No known benefit for autistic children combined with an animal study that suggests that chelating a child with this drug when that child does not have elevated mercury levels in the blood and tissues could actually harm that child? Check. In essence, a risk-benefit ratio of infinity because the benefit is zero? Check. On the basis of human subjects protections and ethics alone, such considerations should have killed this trial dead, dead, dead for a good long time, if not forever. Unfortunately, however, so strong is the unfounded belief that mercury in vaccines causes autism, that even this risk may not be enough to stop this zombie from rising from the dead to feed on autistic children.
An unethical experiment in voodoo medicine indeed.
I realize that one rationale of the trial is that, if no difference were found between the DMSA group and the placebo group, such a result would "would counteract 'anecdotal reports and widespread belief' that chelation works," which is what, indeed, the study outline asserts. Whoever wrote the study outline is charmingly naive. She clearly doesn't know antivaccinationists very well. A negative trial would not in the least deter the mercury militia. Antivaccinationists would just say that it was the wrong drug, the wrong dose, or that the therapy wasn't continued long enough.Then they'd demand another study. If that study were negative, they'd find reasons to discount it, too and demand another one. The ability of antivaccinationists to shift the goalposts is well nigh infinite, as David Kirby's goalpost-shifting has demonstrated. No matter how many studies showed that chelation does not help autistic children, they'd still demand just one more.
And, if this article is any indication, the clueless and hapless Dr. Insel would give it to them, too, no matter how unethical.
ADDENDUM: Steve Novella has more. Money quote:
Therefore, such research is a waste. But it is more than a waste - it subjects the people in the study to the risks of medical research without any benefit to society. If the treatments are highly implausible, then the probability is there was no benefit to the subjects themselves either. Such research seems to be all expense and risk and no benefit.
This puts advocates of science-based and ethical medicine in a difficult position, however. It is hard to argue against doing research - more information always sounds like a good idea. Refusal to even research a question can easily be made by fanatics to seem like suppression of the truth. This can turn the public against those who are most sincerely advocating for their rights, ironically. This motivates some, like Insel, agree to do the research - but this is a sucker's bargain. We have been there before - doing the research accomplishes nothing because the people who need to be convinced are not basing their conclusions on scientific evidence in the first place.
A sucker's bargain indeed.
Kevin Leitch also weighed in. Money quote:
Let's be clear. This study is being touted about for one reason and one reason only - to appease the anti-vaccine/autism groups. In the mainstream medical/scientific community (and notably in the toxicology community) it is well known that autistic kids aren't toxic.
Gee, I'm so glad NIH has money to waste on bullshit! That must mean they've cured cancer, AIDS, depression, irritable bowel syndrome and a host of other human health issues that haven't already been proved to be absolute bullshit.
Oh. Wait. They didn't do that yet? You mean the NIH is spending money to study a "therapy" that can't cure what it's supposed to because the cause is not what the potentially dangerous treatment is intended to treat? (Jeezly-crow, I cant even type that out so it makes sense! Why is it that no one at the NIH is running around screaming about how much the stupid burns? Seems to me they're soaking in it over there.)
This is the kind of news that gets me to thinking that maybe running around the neighbourhood yelling: "We're all doomed! Run for your lives! Hide your children, but vaccinate them first!" might actually be an appropriate response to all of this "woo-madness".
Thanks for this. You didn't mention the series of studies that looked at children with real, moderately high, blood levels of lead (20 and 44 microg/dL). Those children were treated with DMSA chelation, and while their lead levels dropped faster than untreated children, their cognitive performance did not improve more than the placebo group. Indeed, there was some evidence that chelation could impair cognition. And as a consequence, it is no longer recommended that children with these moderate levels of lead in their blood be treated by chelation.
http://pediatrics.aappublications.org/cgi/content/full/110/4/787
Of course, children with autism do not have high levels of mercury in their blood. So, the rationale for treatment is very skimpy indeed.
Yikes! I forgot about that study!
Tom Insel, usually a voice of reason, does seem to have jumped the shark here but I wonder if the motivation to go ahead with this research is really aimed at showing no change with the DMSA so that chelation for autism can be appropriately set aside with a strong study. Remember that secretin was all the rage until several strong studies showed nothing was there. GFCF diet trials are currently underway. There is no good reason to think they will show any benefit (not to mention that this diet is very difficult to stick with and I know of several children that have lost significant weight on it). I'm certainly not in favor of such trials but they do seem to serve a function.
Methinks we should be sending this information to the NIH's Director:
Tom Insel's phone:301-443-3673
Tom Insel's fax:301-443-2578
Tom Insel's e-mail Address: tinsel AT mail.nih.gov
You know what to do.
Perhaps someone can fill me in on the details. But I thought Jenny McCarthy has claimed she's already cured her son of autism. If that's the case, why is she planning on subjecting him to chelation?
Thanks for the reference, Jennifer. I'm adding it to my arsenal.
Is it common for clinical trials to go ahead to prove that something doesn't work? Does it ever happen at all when politics isn't involved?
Cool. Once the results of this trial are published parents will finally realize that chelation doesn't cure autism and they will stop giving kids chelation drugs. Just like the practice of prescribing chelation for coronary artery disease stopped as soon as the NIH proved it was ineffective. Money well spent. [/sarcasm]
"Perhaps someone can fill me in on the details. But I thought Jenny McCarthy has claimed she's already cured her son of autism. If that's the case, why is she planning on subjecting him to chelation?"
So he can be even MORE cured! The more cured, the better.
Dear Orac:
Another reason that this proposed study shouldn't make it past the Scientific Review Board (SRB) is found in the Addendum Prometheus did on Jan. 13, 2008, at http://photoninthedarkness.com/?cat=5 [Links to the study are on his site]:
"ADDENDUM!
Do'C and Interverbal sent me a reference they found on Dr. DeSoto's "FAQ" section that is highly relevant to this topic. They're working on a joint 'blog article on DeSoto's "FAQ" and sent this to me in advance of their post because it seemed so timely. I completely missed it when I read her FAQ, so I'm indebted to these two fine bloggers.
I've put it into an IAQ of its own:
Q. Are there any studies that show what would happen to hair mercury in the presence of true impaired mercury excretion?
A. Yes.
Gundacker et al (2007): "Glutathione-S-transferase polymorphism, metallothionein expression, and mercury levels among students in Austria."
In this study, the authors looked at 222 Austrian students for the presence of deletion polymorphisms of two glutathione-S-transferase genes (GSTT1 and GSTM1) and the resulting hair and blood mercury levels and gene expression of two metallothionein subgroups (MT1 and MT3).
To put a bit simpler, they looked at the effect of deletion mutations of genes critical for mercury "detoxification" on hair and blood mercury levels, as well as the effect on the gene expression of two types of metallothionein (also important for mercury "detoxification"). People who lack a functional copy of the GSTT1 and/or GSTM1 gene(s) are much less able to excrete mercury. They are - in fact - "poor excretors". They have what some in the mercury sub-group of autism advocacy refer to as "mercury efflux disorder".
So, here we finally have the "poor excretors" that Holmes et al thought they had. These are people who actually have an impairment of their ability to excrete mercury.
I won't keep you in suspense any longer. The mean blood mercury was 1.73 mcg/L (min = 0.11, max 7.79, N=222) and the mean hair mercury was 449 ng/g (min = 3, max = 3691, N=174 - 18 subjects didn't provide enough hair for analysis).
Mean hair mercury by genetic group was as follows:
GSTT1 +/+ and GSTM1 +/+ (no gene deletions; "normal"): 244 ng/g
GSTT1 -/- or GSTM1 -/- (deletion in one - but not both - gene): 413 ng/g
GSTT1 -/- and GSTM1 -/- (deletions in both genes): 624 ng/g
These differences were statistically signficant (p = 0.017) by the Kruskal-Wallis test.
That's right, folks. The "poor excretors" had elevated hair mercury. And Dr. DeSoto cited the study that showed it in her own "FAQ". If that's not hoisting yourself on your own petard, I don't know what is.
So much for Holmes et al; so much for DeSoto and Hitlan. Impaired mercury excretion or "mercury efflux disorder" leads to increased hair mercury, not decreased hair mercury.
I wonder if anybody has sent this article to SafeMinds.
A big tip of the hat to Do'C and Interverbal.
Prometheus"
I can imagine trying to explain to a SRB that not only is there no plausible basis for the proposed experiment, but that a study with a very low p showed exactly the opposite of what your hypothesis contends.
The worst thing about this is that negative experimental results will not deter the curebie movement one bit because they are inherently evil at their core. They share the same mentality that motivated people like the Nazis in the 1930s or the MiloÅ¡eviÄ regime in the 1990s. They see autistic people as either inferior to them or a threat to them, and in their minds both must be exterminated.
Disproving the mercury theory, which is believed in by exactly none of the real credible autism experts, is only part of the puzzle. Curebies are monsters who cannot even see their own autistic children as human beings. This is easily demonstrated by some of their own disinformation campaigns. Who else but Suzanne Wright, one of the leaders of the curebie movement, would talk about feeling the urge to kill herself her own autistic daughter by drowning in front of said daughter? It is necessary to make our governments understand that autistic human beings are human beings and deserve certain rights. Protection from curebies being high on the list.
It is also necessary to make our governments understand that if the curebie brigade were to announce tomorrow that a cure for autism has been found, autistic adults around the world would lynch whomever they credited for it. After all of the abuse and torment I suffered at the hands of an ignorant education system, family, and other such authority figures as a child, the offer of or campaigning for a cure begs a question. If you were offered a cure for what makes you unique from people you despise for a good reason, what would your response be? I can tell you this much about the answer: if Jenny McCarthy ever tries to personally "heal" my autism, my thanks will be delivered through the medium of a .50 calibre or larger bullet.
Curebies who might be reading would do well to ask themselves why someone they think they are helping feels this way about them. Scientists would do well to ask why they are wasting their valuable time that could be better spent on solving the worsening overpopulation of our planet (for example) on something the intended recipients have flooded the Internet with writings and videos to the effect that they do not want.
Let's say I grant, for the sake of discussion, the claim Hg (any) causes, among other things, neurological damge manifesting as autism.
Could someone explain to me, even theoretically, the process by which chelation (ie removal of the Hg) reverses this brain damage - thereby curing the child?
I understand, in theory anyway, how it would prevent future damage, but how does the removal of Hg regenerate, restore, heal, fix, cure, etc....already damaged cells?
Anyone? Beuller?
You should look at the Faroe Islands studies on mercury and on autism. There was a consecutive cohort of 996 infants, who had cord blood mercury measured at birth. That is actual cord blood mercury. They have been followed for many years now. ¾ (743) of those children had cord blood mercury levels above 60 nM/L. In the infamous DeSoto study, there were only two individuals with mercury levels that high, they were both rejected as outliers. ¼ of those children (249) had cord blood mercury levels above 200 nM/L.
That cohort of children covered part of 2 years. During those 2 years 1404 children were born. There were 5 cases of autism spectrum disorders, 2 of autism and 3 of Asperger's.
200 nM/L is higher than the peak level found in the blood of those monkeys given mercury in the Burbacher study.
Great. So vaccines are bad because they're "toxic" or whatever, but it's quite OK to give these kids DMSA. Because DMSA's not toxic, oh no.
"Perhaps someone can fill me in on the details. But I thought Jenny McCarthy has claimed she's already cured her son of autism. If that's the case, why is she planning on subjecting him to chelation?"
A most pertinent question, but one which will no doubt not be asked by her throngs of worshippers in the vaccines-cause-autism crowd.
Hey, these are people who think that autism is the worst thing in the whole world and that autistic kids are better off used as guinea pigs for treatments that stand a good chance of causing brain damage than taught how to be high-functioning adults like Dr. Temple Grandin. Because, y'know, chelation therapy is a lot less work than actual parenting, even though it's pricier.
I'm assuming you know about NCCAM?
The NIH evidently wastes much of its money on woo.
Here's another consideration - taxpayers gets to pay for another study the mercury militia can use to "prove" autism is caused by mercury poisoning (vis-a-vis vcaccines) and suck even more undeserved money out of the vaccine fund.
Nothing like taking it in the family jewels - twice.
"Handley's also being either incredibly naïve, disingenuous, or ignorant."
Or a damn liar.
I understand, in theory anyway, how it would prevent future damage, but how does the removal of Hg regenerate, restore, heal, fix, cure, etc....already damaged cells?
One of the big stories in mercury intoxication involves a shipment of seed-grain sent to Iraq years ago. The grain, intended for seed and not ingestion, was ground into four and eaten. Unfortunately, it was coated with organic mercury as a fungicide.
Many of the people were chelated. It didn't improve symptoms.
This is one reason why chelation is not considered a standard treatment for mercury exposures except for recent acute exposures.
My guess is that there is someone out there who is chomping at the bit to tell us all why chelation is appropriate.
"That hypothesis is that autism is in fact a form of mercury poisoning is the basic hypothesis being tested here, with the corollary being that chelation can remove that excess mercury and alleviate the symptoms of autism."
And then they exclude the children who actually have excess mercury.
From the clinical trials listing for the study:
"Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who have not previously received chelation therapy may be eligible for this study.
"EXCLUSION CRITERIA:"
"Level of lead above 10 microgram per d, or level of mercury over 44 microgram per deciliter (toxic levels that require intervention with chelation and preclude placebo assignment) or other evidence of heavy metal toxicity."
So it would appear that they'll be chelating for chelation's sake, as children with excess mercury won't even be in the study.
I thought everybody knew that science progressed by anecdotes, which have to be weighed according to how charming or homespun they are.
Phoenix Woman:
you have inadvertently given Dr. Insel a promotion!
Remember that the NIH is not an institute, since the 'I' is for the plural 'Institutes'. Dr. Insel is the Director of NIMH, which, as any friend of children's literature star Mrs. Frisby knows, is the National Institute of Mental Health.
Anonymous -- the children who actually have toxic levels of heavy metals are excluded from the study because they cannot be part of the double-blinded method -- they will be chelated, with no uncertainty as to which treatment they are receiving, precisely because chelation IS the recommended treatment where there ARE toxic levels of heavy metals! It is unethical to withhold an accepted treatment from someone who needs it! Do you understand the exclusion, now?
Presumably, these children will be monitored during their chelation, anyway. But they cannot run the risk of NOT getting a treatment they need for the sake of a double-blind trial.
It doesn't make all that much difference for the validity of the trial, anyway, given that there is no indication according to blood test that the vast majority of autistic children have toxic levels of mercury or lead to begin with. The "mercury moms" tend to use chelation on children with apparently normal exposure to normal levels of these substances. So testing that is exactly what the trial is meant to do.
Dean M: I wouldn't go as far as you have in describing the curbies, but I do think you've got a point. People who go for this sort of thing, McCarthy, for example, are often very social, outgoing people for whom sociability is one of the most improtant traits any human can have. In short, they are a terrible, disasterously bad fit for an autistic child. And poor fit between parent and child is a better predictor of conflict than any given trait a child or parent might have. So while they may not consciously hate their children, they do resent them, do find it hard to care for them or even react to them properly. For example, any parent dragging an autistic child out into the limelight like that has no empathy for autism or understanding of what it is like. Can you imagine what it would be like for any child, muchless an autistic child, to be dragged out in front of a crowd by his or her parent and shown about as an example of how horrible things can be for the parent. (Because that's the subtext behind statements like, "Do you have any idea what it's like to have an autistic child?" What they really mean is, "Look how I suffer--don't you feel sorry for me?" I wonder if any of them have ever considered what it's like to BE an autistic child--or adult.
Dean M, I agree with what Dianne just wrote.
I am sorry for the abuse and bullying you suffered from people who didn't appreciate you as you are. My son is 8, he's very autistic and I will do everything in my power to improve society to accept and support him as an autistic person.
I am worried however by your depiction of the people seeking a cure as monsters. I know that many of them have said horrible things in public about their children, including doubting their humanity. Such talk is sickening. But comparing them to Nazis and Balkan despots is, I think, going too far. I was also very concerned by your talk, no matter how metaphoric its intention, or unlikely the encounter, of facing a woman down with a gun.
Dianne,
Thanks for that insight.
+++
I predict that both the investigators and the parents of children in both the treatment and the placebo will report 'improvement' in their children's autism during the trial, much like the recent trial on St John's Wort for ADHD in children.
http://www.ncbi.nlm.nih.gov/pubmed/18544723?ordinalpos=1&itool=EntrezSy…
In fact, that is the result of pretty much any placebo controlled clinical trial in autism. The fraction "responding" to placebo treatment is typically on the order of 30% or higher. The classic example is the secretin debacle: A few case reports described dramatic improvement in autistic symptoms after a single injection of secretin, a GI peptide. There was a run on the drug, and thousands of kids were treated with it. Parental reports were enthusiastic. Finally, there were placebo-controlled studies. The secretin group got better. So did the placebo group. No difference. Everybody, researchers included, was so convinced that the effect had to be real, and that they were somehow missing it. All of those enthusiastic parental reports and individual case reports couldn't possibly be wrong, could they? So they did it over and over in different ways. Children with regression. Children with GI symptoms. More doses. Higher doses. They even made it into an ointment and rubbed it on the skin. As a result, we now know more about secretin than any other pharmacological treatment for autism. And all of the controlled studies gave the same result--nada. Fortunately, secretin seems to be essentially harmless. Unfortunately, the same is not true for chelating agents.
I think I can understand where the parents are coming from when they say they are troubled by their child's autism, or talk about how hard it is to live with an autistic child. Let's not sugar coat it -- it IS hard, and it IS disappointing to learn that your parenting job is going to harder than you expected, and that your child is going to face challenges that you will not be able to solve, moreso than normal children. Dianne make a good point that it is probably harder for very social parents, but I would contend that it's difficult for any parent, especially if the child has a severe case. I would not be surprised if a parent could get to a point of briefly wishing that they and their child were dead. People have rightly expressed horror at that notion, but then wrongly concluded that the mother must think her child would be better off dead than autistic. If the mother did think that, she'd kill her kid, and she didn't. That she turned to woo is beside the point. What she was trying to say was that it's very stressful, so stressful that you begin to wish for things that don't make sense. Which is probably why it is so easy for these parents to be suckered in by the woo-meisters.
Your anger at the government for wanting to conduct a study that may help people is self-serving. Aren't you a paid spokesperson for Merck, the company that holds the patents to the vaccines in question? And doesn't Merck fear being liable if parents of autistic kids are correct?
Pharma shill gambit.
Here's a recent study reporting additional progress in identifying the ACTUAL (genetic) causes of autism.
In short, many cases of autism occur when a child has genetic mutations that prevent their brain from making certain proteins that are necessary for their brains to develop properly and/or learn. They have the gene for the protein, but there's a mutation in the part of their DNA near the gene that allows them to make the protein.
It's possible these children may benefit from treatment that gets around this roadblock. They probably wouldn't be neurotypical, but maybe more like Dr. Grandin than the unhappier end of the spectrum. (OK, maybe I'm just projecting, but I tend to believe that someone who communicates by biting and head-banging isn't having a very enjoyable life.)
http://www.hhmi.org/news/walsh20080711.html
This has nothing at all to do with mercury. Nothing. I'm a member of the Genetics Society of America, and based on what I've seen at conferences and read in current peer-reviewed articles by bonafide resarchers, the research that's explaining the biological basis of autism has absolutely NO connection to mercury or other toxins. Either they lack certain genes, the genes can't be read properly, or they have too many copies of certain genes. These changes are inherited from the parents, not caused by substances ingested after birth.
Earlier studies found mutations that could be replicated in mice or other mammals and were found to create autistic-type behavior. Mercury exposure, on the other hand, causes a completely different set of symptoms. Nor was autistic-type behavior observed in animals used for testing vaccines. All of this is old news and can be located easily at pubmed.gov.
Sorry about the duplicate post... had a problem with the submission process. Please delete one, kthxbye!
Callie: I agree. I was in a slightly pissy mood when I wrote the above post. I should clarify that I agree that parenting is hard and parenting a child with autism is harder than usual. I also didn't mean to imply that Jenny McCarthy or people of similar personalities are horrible parents, just that they and their child are unfortunately badly mismatched. And that that mismatch can lead to difficulties that are no one's fault, exactly, but a tragedy nonetheless.
Anonymous -- the children who actually have toxic levels of heavy metals are excluded from the study because they cannot be part of the double-blinded method -- they will be chelated, with no uncertainty as to which treatment they are receiving, precisely because chelation IS the recommended treatment where there ARE toxic levels of heavy metals! It is unethical to withhold an accepted treatment from someone who needs it! Do you understand the exclusion, now?
It did not escape me in the first place.
Presumably, these children will be monitored during their chelation, anyway. But they cannot run the risk of NOT getting a treatment they need for the sake of a double-blind trial.
And I don't think anyone would suggest they should.
It doesn't make all that much difference for the validity of the trial, anyway, given that there is no indication according to blood test that the vast majority of autistic children have toxic levels of mercury or lead to begin with.
Exactly. It's chelation for chelation's sake. No toxicty required.
The "mercury moms" tend to use chelation on children with apparently normal exposure to normal levels of these substances. So testing that is exactly what the trial is meant to do.
I disagree.
"Mercury Moms" I've encountered tend to believe that their children do have actual mercury toxicity. They've often been convinced by mail-order lab tests and internet lore. They don't believe that their children had "normal" exposure to mercury. They believe (based on a dubious hair research) and despite scientific evidence to the contrary, that their children are poor mercury excretors, and that vaccination with Thimerosal-containing vaccines led to high mercury levels which the child somehow can't excrete. Chelator-provoked urine testing convinces them that the children have mercury toxicity. If a child excretes high levels, it means they have mercury toxicity. If a child excretes low levels, it also means that they have mercury toxicity (because they can't excrete). All of this powers the belief in their anecdotes, which have no basis in science.
It's true that the exposure levels probably tend to be normal, but testing a chelator in the relative absence of heavy metals seems quite the waste of time and money. What would that prove? That removing metals that aren't there works?
I think this study is meant to do very little scientifically.
"These changes are inherited from the parents, not caused by substances ingested after birth."
Dear BiologyGoth: You've hit the Blame-Game nail on the head. As the parent of an ASD child, it's one hell of a shot to the emotions to admit that maybe I'm the cause. My ex, however, firmly grasps the latest altie announcement to find someone else to blame.
Whether or not the research in genetics finds something that helps my ASD child, I have two other children, and they want to know the risks before they decide whether to have children. Wasting time and money on this proposed study diverts those limited resources from something that might actually help.
Please keep advocating for better funding of research into the genetic bases of ASD. Your work, and that of other genetics researchers, is deeply appreciated by many who aren't dramatic enough to get headlines.