Chelation: Not as safe as we’ve been told
January 2nd, 2009
Practitioners that promote the “biomedical” treatment of autism often claim that there is little risk of harming an autistic child with the interventions they recommend. “What’s the harm of trying?”, they ask; “What have you got to lose?”
As it turns out, the answer to that question may be “Quite a bit.” Apart from the cost in terms of money, time, effort and false hope, it now appears that one of the prominent “biomedical” treatments for autism may cause neurological damage.
In November, 2008, the journal Neurotoxicology released an “e-publication” of an article that casts further doubt on the efficacy and safety of chelating children with autism.
Rush T, Hjelmhaug J, Lobner D. Effects of chelators on mercury, iron, and lead neurotoxicity in cortical culture. Neurotoxicology. 2008 Nov 5. [Epub ahead of print]
In this study, the authors used primary cortical cell cultures to study the effectiveness of several chelators commonly used to treat “heavy metal poisoning”: calcium disodium ethylenediaminetetraacetate (CaNa(2)EDTA), D-penicillamine (DPA), 2,3 dimercaptopropane-1-sulfonate (DMPS), and dimercaptosuccinic acid (DMSA). All but DPA have been widely used to “treat” autistic children.
They treated the primary cortical cell cultures with four metal “toxicants”: inorganic mercury (HgCl2), methylmercury, ethylmercury (thimerosal!), lead (PbCl2) and iron (Fe-citrate) and then with one of the four chelators (and one control group that received the metals but no chelator). Their results may surprise some people.
DPA performed the worst of all, providing no protection and actually increasing the toxicity of inorganic mercury, thimerosal and iron. EDTA reduced the toxicity of inorganic mercury but “caused a severe potentiation” of iron toxicity.
Both DMPS and DMSA reduced inorganic mercury toxicity but increased the toxicity of thimerosal and iron. DMPS (but not DMSA) increased the toxicity of lead.
Now, these aren’t the results we have been led to expect. [Note: potential understatement of the year candidate]
If this had been the only study to suggest that chelation was potentially dangerous, I would be willing to shrug it off. After all, it is in cell culture, which is a questionable analogue for the intact organism. However, there have been two other studies looking at living organisms that have results consistent with the findings of Rush et al.
Dietrich et al (2004) showed that treating children with blood lead levels between 20 and 44 mcg/dl with DMSA [Note: chelation therapy with DMSA is recommended for blood lead levels of 45 mg/dl and above but not specifically recommended - or contraindicated - for blood lead levels from 10 - 44 mcg/dl] had no effect on a variety of neurocognitive tests at long-term follow-up (4 - 5 years).
However, they found a statistically significant decrease in attention and executive functions in the children treated with DMSA when compared to placebo. Given the nature of neurocognitive testing and the variation in genetic and environmental factors in humans, this result was not given a great deal of weight at the time.
In 2007, Stangle et al showed that DMSA, when given to rats that were truly lead-toxic (i.e. blood levels in the toxic range without “provocation”) improved learning and etc., but that when they gave it to rats that did not have toxic lead levels (i.e. the control group), there was a significant and sustained (i.e. permanent - it did not disappear during the duration of the study) decrease in cognitive function.
What does all this mean to parents who are - or are contemplating - chelating their autistic children? Well, it strongly suggests:
[1] Chelation with EDTA, DPA, DMPS and DMSA does not “work” for organic mercury, such as ethyl mercury from thimerosal. The Rush et al study was particularly pertinent to parents who think their children became “mercury poisoned” from thimerosal-containing vaccines, since it used thimerosal as the source of ethyl mercury.
[2] Giving DMSA or other chelators to children who do not have significant blood levels of heavy metals is likely to cause brain damage. It is probable that the chelating agents cause some degree of neurological damage, but that higher lead (or other heavy metal) levels cause sufficiently greater damage that the chelators are the “lesser of two evils”.
Many parents (and not a few practitioners) have argued, “Chelation is safe; why not give it a try? It can’t hurt and it might just help.” Well, now we have a growing body of data suggesting that chelation might not only be ineffective, it might make your child worse.
Since many practitioners following the “DAN! Protocol” or similar regimens commonly give chelating agents when (unprovoked) blood/urine levels of mercury (or other metals) are well below the toxic range, these studies are directly applicable to this practice.
An additional concern is that practitioners (and do-it-yourself parents) who chelate to “treat” autism often continue giving these drugs for years. Even the treatment of lead toxicity - which takes much longer since lead is incorporated into the bones - is usually limited to six months to a year, with careful monitoring.
People who may be tempted to smugly ignore these warnings because they are using “natural” chelating agents or other agents not mentioned in these studies should rethink their complacency. The mechanism that causes the cognitive impairments seen after DMSA treatment - and the toxicity to cell cultures seen after DPA, EDTA, DMSA and DMPS treatment - is unknown. It may well be that any heavy metal chelating agent can cause the same injury.
Prometheus
Filed under: Autism Practitioners, Autism Science, Autism Treatments | 27 Comments »
“Let’s put on a Study!”
November 3rd, 2008
Once again, there is a hue and cry to “do a study” about vaccines and autism, this time pushed forward by commentors on David Gorski’s recent post on the “Science-Based Medicine” ‘blog. Whenever I hear people who have never tried to do any study - let alone a study of human children - say “We need to do a study!”, I can’t help thinking of Mickey Rooney and Judy Garland and their “Let’s put on a show!” musical films - ergo the title of this article.
As I expected, the commentors put forth many of the same arguments that haven’t worked before but this time they are doing their math, something I appreciate. So, in appreciation, I have prepared the following:
The Reason:
The interest in “doing a study” seems to stem from the idea that the only way to find if vaccines are connected with autism is to study unvaccinated children and compare their autism prevalence with vaccinated children. This is not true and is - in fact - not even the most effective way to study the postulated connection, as I will show later.
Much of the blame for this wrong-headed fixation on “Just study the unvaccinated!” can be laid at the feet of Dan Olmsted, who claimed that the Amish don’t vaccinate and don’t have autism. Both claims - it turns out - are untrue. The Amish do vaccinate and they do have autism. Apparently, Mr. Olmsted didn’t look in the right places for his information about the Amish. And if you don’t look, you never find.
The same argument - if you don’t look, you don’t find - has been used to argue for studying the “connection” between autism and vaccines. However, researchers have looked. They looked at thimerosal and autism - and found no correlation. They looked at the MMR vaccine and autism - and failed to find a correlation. Now, with their backs against the wall, the vaccines-cause-autism believers have shifted from distinct vaccines or vaccine components to vague “toxins” or the even more vague “too many, too soon”.
Despite an absolute lack of data supporting either claim (’toxins” or “too many, too soon”), the proponents have argued that “we need to do a study” of vaccines and autism. “We” (i.e. the taxpayers) may indeed end up “putting on a study” in response to the political pressure these groups may bring to bear. I have no illusions that any research will ever be able to convince these people that they are wrong. After all, they haven’t been swayed by any research done so far.
However, since we’re all going to end up paying for this study, we should ask that it be done in the most effective way possible, rather than simply following the uninformed dictates of the vaccines-cause-autism believers.
The Amish:
Let me dispose of one line of “reasoning” that often comes up when these “Let’s put on a study” promoters gather. It is often suggested that we “take advantage” of existing groups of people who do not vaccinate their children. Mr. Olmsted proposed the Amish, although it later turned out that the Amish do vaccinate their children, although not at the level seen in the population at large. Another proposed study group was a health care group in Chicago that practiced non-vaccination and also - we are told - had a low to zero autism rate.
The problem with selecting “special” populations to study is that they are not comparable to the general public. The Amish - probably the most dramatic example - have a much higher prevalence of several genetic disorders as a result of generations of inbreeding. They are not comparable to the US population for this reason and any results obtained from studying them would be irrelevant. I suspect the main reason for wanting to study the Amish was that Mr. Olmsted “found” that they don’t have any autism - which was, as I’ve said above, also incorrect.
Even if we were to study a group like that in Chicago, the question would arise, “What other differences (besides vaccination) are there?” Do they only eat organic foods? What else might account for any differences between them and the general population. And if no difference in autism prevalence were discovered, would that be enough to satisfy the folks crying to “put on a study” or would they simply shift their sights to another group?
No, the only way to correctly do a study of vaccines and autism is to compare children who are matched for age, sex, geographic location, rural/urban/suburban setting, socio-economic group and race. That way, the only differences (we hope) would be vaccination status and autism prevalence.
The Numbers:
If we’re to do a study (as opposed to “putting on” a study), we need to have an idea of the numbers of subjects we’ll need to test in order to come up with a statistically meaningful result.
In 2004, Smith et al published “Children who have received no vaccines: Who are they and where do they live?”. This was an extensive study of vaccination practices in the US, carried out from 1995 to 2001 on over 23,000 children selected at random to be representative of the larger population. Their results were interesting and bear directly on the desire to “put on a study” looking at the connection (or lack thereof) between vaccines and autism.
What they found was that 62.8% of their study population was “fully vaccinated” (i.e. had received all the vaccines on the then-current vaccination schedule - 15 total in 2001). An additional 36.9% were “undervaccinated” - although 58.5% of them (20.4% of the total sample) were missing only one vaccine. Only 0.3% of the sample - 111 children ages 19 - 35 months over five years - had not received any vaccination.
I’d like to emphasize a point. The Smith et al study only looked at children 19 - 35 months of age, which is well before school age, at which time undoubtedly a few more tenths of a percent of the unvaccinated were whittled away. However, this age includes the ages where children have been reported to have “regressed into autism” following vaccines.
So, any study of unvaccinated vs vaccinated children has to deal with the fact that the “pool” of unvaccinated children is about 0.3% (or less) of the total population. Even if we could extend the Smith et al findings to the entire 0 - 17 year age range (”children”, by most definitions), this works out to only about 223,000 completely unvaccinated children. Given that at least some of the children who were unvaccinated before 35 months will have gotten at least one vaccination by their teen years, this number is sure to be much smaller.
For the purposes of this demonstration, let’s limit the study group to younger children, both to eliminate the uncertainty about the number of unvaccinated children and to keep the diagnostic criteria somewhat comparable. After all, the criteria used to diagnose the 17 year-old autistic children were very different from those used today.
How about we settle on the 3 - 6 year age range? This puts them past the scheduled time for the majority of childhood vaccinations and yet cuts off before the “school vaccination mandate” years. According to the US census bureau, this age group (as of August 2008) contains 16,550,753 children. Of that number 49,652 (or less) might be completely unvaccinated (and over ten million “completely vaccinated”).
What sort of sample numbers do we need to “prove” the vaccine-austism question? Well, let’s make a few assumptions. The first assumption is that we will want to have a sample size large enough to be sure that we have less than a 5% chance of mistakenly saying there is a correlation if there isn’t (alpha error) - and we’ll want a less than 5% chance of saying there isn’t a correlation if there is one (beta error) in order to satisfy those who want to “put on a study” (normally, we’d accept a 20 - 50% chance of mistakenly saying that there is not a difference when there is one).
Secondly, we’ll have to stipulate what sort of difference we expect to find between the two groups. If the “fully vaccinated” group had 50% more autism than the “unvaccinated” group, would that be enough of a reason to change vaccination policies? Would a 10% difference be enough? More to the point, how small a difference will be small enough for the vaccine-cause-autism proponents to say “I was wrong, vaccines don’t cause autism.”?
That last point may be the one that actually torpedoes the study. Because if there is no number small enough to convince those who want the study that they are wrong, most of the reason for doing the study vanishes.
Let’s say - for the sake of argument - that we decide that a 10% difference in autism prevalence is enough to convince the skeptics that vaccines might cause autism and that a less than 10% difference will convince the believers that vaccines don’t cause autism. [I know, the latter assumption is pure fantasy.]
Well, plugging those numbers in - along with the current 1 in 150 autism prevalence - we find that we need over 360,000 children in each group to detect a 10% difference (you can try it yourself here). Unfortunately, that is more than the total number of unvaccinated children in the US, so that’s not going to happen.
What can we get with our “sample” of 49,652 unvaccinated children? If we manage to include each and every unvaccinated child in the US in the study, we could detect a 26% or more difference in autism prevalence.
Of course, it’s not even remotely practical to expect to get 100% of the unvaccinated children in the country into a study. How about a more practical number - say, 10% of them? That would allow us to detect a 70% or greater difference - about a three-fold difference in autism prevalence between the fully vaccinated and unvaccinated groups.
Now, if a difference of this magnitude or greater were found, that would pretty effectively silence those who say that the data haven’t shown a connection between vaccines and autism. I would certainly change my opinion (from “not shown” to “strong indication”).
But what if the results go the other way? What if the results are “negative”, meaning that the difference is less than 70%? Would that be enough to get the vaccines-cause-autism crowd to stop protesting and stop sending death threats? I doubt it.
Of course, there are those who believe that the results will be unambiguously in favor of their belief that vaccines-cause-autism. They want the study to go forward because they are confident that they will be vindicated. They are also the people who will rant about “bias”, “flaws” and “corruption” if the data don’t go “their way”.
Another other thing to consider is that a study with almost ten thousand children enrolled would be exorbitantly expensive, especially as they would all have to be tested carefully for autism. Even using a very conservative figure of $150 for an evaluation, that’s over $1.5 million just for the autism testing.
Don’t forget that research money, time and facilities are not infinite. Resources spent chasing the vaccines-cause-autism “connection” will have to come from other research areas, and the most fair way to do that would be to take them from other autism research. Thus, much time and money is spent to accomplish little…or nothing.
And is it likely that you could get the parents of 10% of the unvaccinated children in the country to enroll them in a study? Given that many of these children are unvaccinated because their parents harbor deep suspcions about doctors and “the government”, it seems unlikely.
Finally, let’s “run the numbers” on a more practical study - one where we are able to enroll 500 unvaccinated children and 5000 fully vaccinated controls matched for age, sex, socioeconomic group, geographic location, urban vs rural vs suburban setting and race.
This study - which would still be very difficult and expensive to do - would only be able to detect a more than 15-fold difference in autism prevalence between the two groups. It could detect as little as a 7-fold difference, but only if we were willing to accept a beta error (chance of erroneously saying there is no difference when there is a difference) of over 50%.
I doubt this would “satisfy” the vaccines-cause-autism believers if the results were negative.
So, before someone tells me - again - how easy it would be to study autism in unvaccinated children, first go out and try to find a few thousand completely unvaccinated children and then tell me how easy it is.
Ethical Considerations:
Another suggestion made was to have a study where children are placed into “no vaccination” and “vaccination” groups. This, of course, would be rejected out of hand by any Institutional Review Board because the risks of not vaccinating are well known and quite serious. On the other hand, the connection between vaccines and autism is tenuous at best. It would be unethical to expose adults to a known serious risk in order to test a weakly-supported (again, at best!) possible risk. In children, it would be unthinkable.
Another “modest proposal” was to vaccinate one group per the suggested schedule and vaccinate another group with four times the amount of vaccine. Well, at least this commentor understands the concept of “dose-response”. If - as some people argue - the current amount of vaccine is causing some amount of autism, then it would be reasonable to expect that more vaccine would lead to more autism.
Of course, the idea of doing something with the intent of causing harm to children is unlikely to pass the ethical hurdles of a real IRB. However, even if the hypothesis is incorrect - even if the researchers argue that harm is extremely unlikely, they would still be exposing children to four times the dose used during the safety trials of the vaccines, which would constitute an unreasonable risk, especially to test a hypothesis that is already weak.
Additionally, if the results are “negative”, the vaccines-cause-autism proponents could (and would) argue that their hypothesis is correct but that the threshold for causing autism is lower than the “standard” vaccine regimen (you know, the “too many, too soon” argument). Thus, the argument for doing the study (absent the obvious ethical considerations) has largely disappeared.
An Alternative:
Part of the difficulty in doing a study of unvaccinated children is tracking them down. There is no national or even statewide database that can “spit out” the names of unvaccinated children; you’d have to track them down one by one, a process that can take years to complete, given the numbers needed.
Additionally, the proposed study design wastes the effort used to collect the subjects based on a single variable - vaccination.
A much better study design would be to look at two age, sex, etc. matched sets of autistic and non-autistic children. Autistic children are more “visible” in the medical and educational systems than unvaccinated children (who are often “under the radar”). It would be easier (although not easy) to recruit autistic children and non-autistic control subjects than it would be to track down thousands of unvaccinated children.
Another advantage is that the researchers could collect data on a wide variety of exposures, genetic issues and other variables that could later be “mined” to find other promising avenues of research. This in contrast to the “single issue” study looking at unvaccinated children, which can only compare issues related to vaccination.
Even with those advantages, the study will be “swimming upstream” a bit.
A study of autistic children in the 3 - 6 year age range would need over 683,000 children in each group to detect a 10% difference in vaccination level. It would need nearly 22,000 in each group to detect a 50% difference. With a predicted number of 110,000 autistic children in that age range, that is a sizeable fraction of all autistic children.
A more manageable study - one with 10,000 children in each arm (which is still a HUGE study!) - would only be able to tell the difference between the national average of 0.3% unvaccinated in the non-autistic group and 0.1% unvaccinated in the autistic group (at the specified levels of confidence). If the difference is smaller than that, the results would be considered negative (i.e. that there is no effect of vaccination). For reference, a study with 1,000 children in each arm would show statistical significance (at our specified level of confidence) only when the autistic group was below 0.01% unvaccinated or above 1.7% unvaccinated.
Of course, we wouldn’t have to just look at unvaccinated vs fully vaccinated with this study, which is a large part of its superiority. We could look at a dose response of vaccination - to see if it really is “too many” - as well as the age at youngest vaccination - to see if it really is “too soon”. In fact, a few studies have already looked at those issues and found that there is no difference between the autistic and non-autistic groups. I suspect this is the reason the folks pushing to “put on a study” want to look at vaccinated vs unvaccinated - they hope that the numbers will be different (or, at least, not as definitive) the other way round.
Conclusions:
The current push to “put on a study” comparing the autism prevalence in vaccinated and unvaccinated children is likely to come to political fruition long before it generates any real scientific interest. Anyone who has actually done a human study will recognize that the proposed study format - find a bunch of unvaccinated kids and compare their autism prevalence to the general population - has serious problems.
If our political leaders eventually find it expedient to “put on a study” in a vain attempt to quiet the protests of the vaccines-cause-autism fringe, then we need to be prepared to insist that it be a proper study, not a rigged “study” pre-ordained to find the “correct” results.
Prometheus
Filed under: Autism Policy, Autism Science, Critical Thinking | 23 Comments »
Advocatus Autismus Diaboli: Advocacy from Hell
October 27th, 2008
A few weeks ago, on the Autism Street ’blog, I saw a discussion of the distinction between autism advocacy and anti-autism advocacy. It started me thinking - always a chancy thing.
One commentor gave a definition of autism advocacy - one which I think that few people would disagree with:
“[A]utism advocacy” has to do with understanding and support of families affected by autism, educational needs of children with autism, becoming educated about, and advocating for meeting the needs of older children and adults with autism, advocating for needed services in the community and like topics.
A second commentor came up with a good definition of how “autism advocacy” is seen by autistic people themselves.
“Autism advocacy” is the widespread effort to make the world as free of autism — that is, of autistic people — as possible.
The ’blogmaster, D’oC came up with the term anti-autism advocacy to describe those people whose goals - stated or implied - fit the latter definition better than the former. I don’t know if he coined the term or found it somewhere else, but it truly fits.
As I contemplated this curious dichotomy, it occurred to me that most organizations, governmental agencies, foundations and informal groups that claim “autism advocacy” as part of their mission seem to fall into the anti-autism advocacy category.
This isn’t to say that even the most militantly “autism-is-the-scourge-of-the-earth-and-must-be-eradicated-completely” group doesn’t - on the rare occasion - do something that at least partially helps actual autistic people; most groups (there are exceptions) have a mix of both activities. However, most of the more prominent groups seem to lean rather heavily to the “anti-autism” side and give only lip-service to helping autistic people (apart, of course, from “curing” them).
There are, in fact, very few organizations or groups that are predominantly focused on helping autistic people, as opposed to parents of autistic children. I won’t go into who is and who isn’t, since that would distract from the point of this article (not to mention exposing me to lawsuits - some of the anti’s are also very pro-lawsuit).
What I’d like to do is propose a set of definitions to “disambiguate” our discussions of “autism advocacy”. I’d also like to introduce a term of my own.
Definitions:
[Note: the activities included in the definitions below are NOT meant to be an exhaustive list of what the different types of advocacy involve. Failure to include an activity in the admittedly short list included in the short definition should NOT be construed to imply that the author feels that that activity is NOT a part of that type of advocacy. Thank you for not putting words in my mouth.]
Autism Advocacy: Speaking for, lobbying for or otherwise working to improve the lives of people with autism. This would include - but not be limited to - removing obstacles to greater independence, helping them to reach their highest potential and assisting them to express themselves in words, writing, art and music. It would also include helping autistic people free themselves from oppression, abuse and exploitation. This would also include researching and disseminating accurate information about autism.
Anti-autism Advocacy: Speaking for, lobbying for or otherwise working to eradicate autism. This would include - but not be limited to - researching the causes of autism, ways to prevent autism or ways to treat or “cure” autism. Included in this would be efforts to disseminate and publicize accurate information about causes, prevention and treatment of autism.
I think from those two definitions, you could figure which groups do autism advocacy and which groups do anti-autism advocacy. But I think that there is a piece of the puzzle missing - and here it is!
Autism-angst Advocacy: Speaking for, lobbying for or otherwise working to increase the public fear of autism. This would include - but not be limited to - disseminating informational material implying that autistic people are unable to function independently or have a reasonable quality of life, that autism in its greatest severity is the norm, that common activities, household products or medical interventions cause autism (without data to support such a claim) or that children with autism do not develop at all without extensive use of untested psuedo-medical “therapies”.
I think that this third cetegory describes certain autism-related groups better than either of the other two. After all, there are certain organizations that seem to be uninterested in helping autistic people and yet are not actively working to find a cause, prevention or cure. What they do seem to be doing is stirring up a lot of fear and anger. Thus, autism-angst advocacy - for the people who don’t want to be part of the solution.
Autism-angst advocacy appeals to the people who want someone to blame, who want those smug, satisified parents with “typical” kids to share their fear, who want to show the world that there’s nothing wrong with their genes, by damn! It attracts people who aren’t ready to deal with the child they have and want to spend a little more time wallowing in fear and anger over the child they didn’t get.
It also appeals to people who are tired of doctors and scientists being the only ones who can do meaningful medical research. It’s very post-modern in its ideas that the “narratives” of parents are the equal of any “numbers from a study” or “epidemiological herd”. This also appeals to many second- and third-tier “alternative” practitioners, who find the “Data!?! We don’t need no stinkin’ data!” attitude very conducive to their practice.
The ultimate purpose of autism-angst advocacy is harder to fathom, since increasing fear and anger about autism will not help autistic people (quite the opposite!), their families (ditto!) or autism research (double ditto!). In fact, it makes no sense at all unless its purpose is to generate an inchoate anger that can be directed at whatever target - vaccines, doctors, “the government” - that the leaders choose in order to generate political power.
Of course, it doesn’t have to make sense. It may be that the leaders of the autism-angst movement have no purpose at all beyond wanting other people to be as frightened and angry as they are. Misery loves company, we are told, so it would definitely like a rally…or a mob.
Whichever way the autism-angst advocacy groups are heading - directed mass action or accidental mob implosion - we should all be keeping an eye on them.
Prometheus
Filed under: Autism Policy | 44 Comments »
Secretin Rises from the Grave!
September 30th, 2008
From time to time, I receive comments like:
"Why are you so opposed to studying ‘alternative’ therapies that have a low probability of working? If the study shows the therapy doesn’t work, people will stop using it."
Oh, if that were only true!
Let’s take – for example – the use of secretin as a therapy for autism. This has been repeatedly shown to be ineffective (no better than placebo), yet it keeps rising from the grave like some unquiet corpse.
Although it’s a bit early for Halloween, Stephen M. Edelson (PhD) of the Autism Research Institute has once again raised the "secretin-cure-autism" hypothesis from the dead. It is now roaming the "alternative" autism therapy community, munching on the brains of the "reality challenged". You can read it yourself in the ARI newsletter, Autism Research Review International (volume 22, number 2, pages 3 and 6).
In his editorial, Dr. Edelson starts with an abbreviated (and redacted) timeline of the secretin "controversy" (he says "controversy", I say "debacle"). He then goes on to explain why his unscientific parent survey of treatment effectiveness is a significantly better measure of the effectiveness of secretin than the over twenty studies that have been done to date. Among his "reasons" are:
[1] The largest studies (including the Repligen Corporation’s Phase 3 study) used human secretin instead of porcine secretin. Porcine secretin, you see, was what was used in the earlier, smaller, less well-designed studies that showed some effect. More about this later.
[2] The studies didn’t focus on the children with gastrointestinal problems – specifically chronic diarrhea and chronic constipation – which (again, in the few studies that showed an effect) were the children who showed the most effect.
Secretin Timeline
For those who are new to the scene, let me give you a capsule summary of the rise, fall, and (at least for a while) death of the "secretin-cures-autism" hypothesis. You’ll notice that many of the details I cover are not included in Dr. Edelson’s timeline. Case reports and studies showing that secretin is an effective treatment for autism are in red , studies that show that secretin is no better than placebo are in blue .
A few definitions that might come in handy:
Double-blind : Neither the subjects (or their parents) nor the researchers knew which treatment the subjects were receiving until after the final evaluations were recorded. This keeps the patients/parents and researchers from unconsciously "shading" their interpretation of the results based on their knowledge of which subjects are getting the drug.
Randomized : The subjects were assigned to the treatment (secretin) or placebo group at random. This helps to prevent a certain "type" of patient from being assigned to the drug or placebo groups. Without randomization, "sicker" children might be assigned to the drug group (or, conversely, they might be shunted over to the placebo group to keep from "screwing up" the results).
Crossover study : In a crossover study, the subjects are assigned to one of two (or more) groups. One group receives the study drug (secretin, in this case) and the other group receives the placebo. After a suitable "washout" period to allow the effects of the drug (if any) to dissipate, the group that initially received the drug gets a placebo and the group that initially received the placebo gets the drug. This allows the subjects to act as their own "controls" (sort of – there are some problems with this assumption).
1996
1996 – Parker Beck undergoes an upper GI endoscopy at the University of Maryland hospital. During this procedure he receives – as is typical – an injection of secretin to stimulate pancreatic secretion so that the gastroenterologist can confirm that the pancreatic duct is open (patent) without having to inject X-ray contrast, which carries the risk of causing pancreatitis.
A few days later, Parker – who was autistic – began to talk for the first time. [Note: at least one source – written by Bernie Rimland – states that Victoria Beck (Parker’s mother) had to INSIST on the secretin injection. This seems unlikely, since secretin is a routine part of upper GI endoscopy AND because she would have had no reason to insist on secretin, as it had never before been associated with improvement in autism.]
According to Ms. Beck – documented in numerous interviews – Parker remained verbal with improved social interaction even though he received only a single dose of secretin until a approximately year later.
1997
1997 (approx) – Parker Beck begins receiving repeated secretin injections.
December 1997 – Repligen Corporation stock trading at $0.78 on volumes of 65,600 shares.
1998
A case report of three (3) autistic children who received secretin as part of endoscopy and showed improvement.
May 19th, 1998 – Victoria Beck and Dr. Karoly Horvath file a patent (#6,020,310) on the use of secretin for the treatment of autism and for the use of secretin levels in the diagnosis of autism. This patent was later sold to the Repligen Corporation.
September 1998 – Repligen Corporation stock selling at $1.31 a share with volumes of about 41,000 shares.
October 1998 – Victoria Beck – Parker Beck’s mother – appears on both "Dateline" and "Good Morning America" to reveal to the world how secretin cured her child.
October 16, 1998 – Ferring Pharmaceuticals - the only manufacturer of secretin at the time – sells its last vial of secretin. The company had decided earlier to stop manufacturing secretin due to the low demand, a decision which should go down in economic texts as an example of epic bad timing.
November 1998 – Repligen stock trading at $1.69 on volumes of 37,000 shares.
1999
January 13, 1999 – Victoria Beck and Bernie Rimland file a patent (#6,197,746) on methods of administering secretin for treating autism that includes (besides injection):
"Other methods and compositions for administering the effective amount of secretin include other transdermal carrier substances, such as gels, lotions, or patches; oral carriers, such as tablets, capsules, or lozenges; inhalation through the nose or mouth (e.g., as an aerosol); suppository forms of secretin and secretin compositions; and using acoustic waves to cause the secretin to penetrate the skin."
This patent was later sold to the Repligen Corporation
March 1999 – Bernie Rimland publishes an "update" on secretin in the ARI newsletter . In it, he mentions how Victoria Beck patented the use of secretin for the treatment of autism and how she fought off attempts by the "university medical school doctors" to try to patent it.
He fails to mention that he is also a holder of a patent on the use of secretin for autism (see above). Dr. Rimland mentions in passing that the Becks sold their patent to Repligen Corporation and donated the proceeds and royalties to ARI, which at that time was owned and operated by Bernie Rimland.
March 1999 – Repligen stock trading at $3.06 on volumes of over 200,000 shares.
1999 – Victoria Beck’s book, "Confronting Autism: The Aurora on the Dark Side of Venus: A Practical Guide to Hope, Knowledge, and Empowerment" is published.
A study of 56 children with autism. Randomized, double-blind placebo controlled, single dose. No effect seen from secretin.
2000
February 2000 – Repligen stock trading at $13.13 per share on volumes of 1.3 million shares.
A study of 56 autistic children. Open label (both researchers and parents knew what the child was getting), single injection. A second double-blind placebo-controlled study was done with 17 children who had responded the most in the first study and 8 new subjects who got an additional injection of secretin or placebo with crossover at four weeks.
"Results of both inquiries indicate that although treatment with secretin was reported to cause transient changes in speech and behavior in some children, overall it produced few clinically meaningful changes when compared to children given placebo injections."
A study of 95 autistic children. Placebo-controlled, randomized, double blind – single injection of either secretin or placebo. "No significant differences in language or autistic behaviour measures were observed at the 3-week follow-up between the groups."
2001
March 5, 2001 – Victoria Beck and Bernie Rimland file a patent (#6,790,825) for "Method of using secretin and compositions made therefrom for the treatment of autism and other neurological, behavioral and immunological disorders". This patent was later sold to the Repligen Corporation.
April 2001 – The Repligen Corporation, which makes recombinant human secretin, completes a Phase 2 study of secretin in autistic children.
May 2001 – Coniglio et al. A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism. J Pediatr . 2001 May;138(5):649-55.
A study of 60 children with autism. Placebo-controlled, randomized, double-blind – single dose of either secretin or placebo.
"A single dose of intravenous secretin does not appear to have significant effects on either parents’ perception of autistic behaviors or language skills at 6 weeks after injection. Transient, marginally significant improvements in autistic behaviors may occur in some children."
A study of 64 autistic children. Randomized, placebo-controlled, double-blind – each child received either two doses of porcine secretin or two doses of placebo. "No evidence is provided for the efficacy of repeated doses of porcine secretin in the treatment of children with autism."
“Secretin hormone given daily in transdermal cream was associated with marked and sustained developmental progress in an aphasic two-and-a-half year old child diagnosed with autism.”
A study of 12 autistic children. Randomized, placebo-controlled, double-blind – single dose crossover study. Outcome measures included gastrointestinal problems.
"Statistically significant differences were observed on measures of positive affect and activity level following secretin infusion. In general, the autistic children did not demonstrate the improvements described in the initial retrospective report."
October 2001 – Dr. Walter Herlihy of Repligen Corporation (the company trying to get FDA approval to label its recombinant human secretin for the treatment of autism) gave a presentation at the "Defeat Autism Now!" conference in San Diego, CA.
In this presentation, he reported that the Phase 2 trials [Note: Phase 2 trials are intended to show that the proposed treatment is safe in the intended patient population] did not show a statistically significant difference (in safety or efficacy) between secretin and placebo. He argued that the criteria for statistical significance were "arbitrary" and that secretin had shown more effect on younger children with gastrointestinal problems like chronic diarrhea and constipation.
A study of 56 autistic children. Randomized, double-blind, placebo-controlled – crossover study of one injection of either placebo or secretin followed in four weeks by the opposite treatment.
"There was no evidence for efficacy of secretin in this randomized, placebo-controlled, double-blind trial."
2002
April 2002 – Repligen Corporation starts a Phase 3 trial of secretin in autistic children. Based on preliminary (and statistically non-significant) results from their Phase 2 trial, they focus the trial on children ages 32 – 59 months (2 ½ - 5 years) and looked specifically at gastrointestinal problems – primarily chronic diarrhea and chronic constipation.
April 5, 2002 - Repligen obtained FDA approval to market its brand of synthetic porcine secretin (SecreFlo TM) for use in pancreatic assessment.
A study of 6 autistic children. Randomized, placebo-controlled, double-blind crossover study. Each child received six injections – three placebo and three secretin – in random order every four weeks. "In this placebo-controlled study, multiple doses of secretin did not produce any symptomatic improvement."
A study of 19 autistic children, 5 with "chronic diarrhea". Randomized, placebo-controlled, double-blind crossover study – single injection of either secretin or placebo followed by the opposite treatment at three weeks.
Analysis of the entire group showed no statistically significant effect. Limiting analysis to the five (5) children with chronic diarrhea (but not the two with chronic constipation) gave statistically significant results.
A study of 85 autistic children. Randomized, placebo-controlled, double-blind – single dose. The children were divided into trios matched by age and communication level – one child from each trio received porcine secretin; one received synthetic (human) secretin and one received placebo.
"No evidence that either biologic or synthetic secretin provided amelioration of symptoms beyond placebo was observed. This held true when children with and without gastrointestinal problems were examined separately ."
December 20, 2002 – Victoria Beck and Dr. Karoly Horvath file a patent (#7,091,182) for "Method for assisting in differential diagnosis and treatment of autistic syndromes" which is described as "comprising the administration of a therapeutically effective, preferably intravenous, dose of secretin to an individual with autistic syndrome" and "an analysis of an individual’s blood and/or intestinal tissue for the presence of secretin and comparison of the level of secretin to known norms". This patent was later sold to the Repligen Corporation.
A study of 42 autistic children. Randomized, placeb-controlled, double-blind – crossover study. Each child received either placebo or secretin and then the opposite treatment at six weeks. "There were no significant differences in the mean scores on any measure of language, behavior, or autism symptom severity after treatment with secretin compared to treatment with placebo."
2003
A study of 62 autistic children. Randomized, placebo-controlled, double-blind – crossover study. "Five children showed clinical improvement in standard scores: two after HSS [human synthetic secretin] and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo."
From Part II:
"At the conclusion of the study, parents were asked to guess their child’s group assignment. Twenty seven families guessed their child’s group assignment correctly and 27 guessed incorrectly."
September 2003 – Repligen stock trading at $7.47 a share on volumes of about 400,000 shares. Its cash value is estimated at about $1 per share.
December 2003 – Repligen stock trading at $4.37 a share on volumes of 740,000 shares.
2004
January 5, 2004 – Repligen announces that there were no significant differences between the treatment and placebo groups in its Phase 3 study of secretin for autism. This study – although Dr. Edelson seems unaware of the fact – focused on younger children and also looking at chronic gastrointestinal problems.
January 2004 – Repligen stock trading at $3.33 on volumes of over 2 million shares.
Early 2004 (exact date difficult to determine) – Dr. Rimland sends a letter to Walter Herlihy of the Repligen Corporation essentially denouncing their decision to declare that secretin was no more effective than placebo.
July 2004 – Repligen stock bottoms out at $1.62 a share on volumes of 200,000 shares.
2005
A study of 15 autistic children. Randomized, placeb-controlled, double-blind – crossover study. Transdermal secretin or placebo was applied daily to the backs of children for four weeks. After a six-week "washout" period, the groups switched treatments.
"Overall, there were no statistically significant differences in speech, sociability, sensory, and health scores for treatment versus placebo periods. In addition, there were no differences in such scores for children with a history of diarrhea."
November 2005 – Repligen Corporation starts a Phase 2 trial of secretin for the treatment of schizophrenia.
Present
September 25, 2008 – Repligen stock trading at $4.89 on volumes of 45,000 shares. The company has a little over 31 million shares outstanding.
Human vs Porcine Secretin:
Between 1998 and today, over 20 studies have been done (and published) to determine the effect of secretin on autism. At least nine (9) used porcine secretin and at least four (4) used human secretin. For the others, the methods section didn’t specify or was unclear (initially, only porcine secretin was available, so there was no need to specify). The results of the Repligen Phase 3 study have never been published.
Only three secretin studies (with a total of 23 subjects – really only 9 if you consider that Kern et al found a positive effect only among the 5 children with chronic diarrhea) found any effect on autism. At least twelve other studies – with a total of 609 children enrolled – showed that secretin had no effect in the treatment of autism. Despite this, Dr. Edelson is convinced that secretin "works" for autism. He attributes the discrepancy to the "fact" that the largest studies (by Repligen) used synthetic (recombinant) human secretin instead of the porcine secretin used in the earlier studies.
Well, he’s wrong on a couple of counts.
To begin with, many of the larger studies used porcine secretin – one even compared it to both synthetic (recombinant) human secretin and placebo (all three were equally effective).
Secondly, the difference between human and porcine secretin is only two amino acids out of twenty-seven. Only dogs have a secretin molecule that’s closer to ours than the porcine secretin. In addition, the two substitutions – aspartate for glutamate and serine for glycine – would have minimal effect on the function or structure of the protein. Aspartate and glutamate both have carboxylic acid side chains and serine’s higher affinity for water – compared to glycine – would be masked by the fact that it’s situated right next to aspartate, which is very hydrophilic.
In fact, if Dr. Edelson had bothered to check, he would have found that porcine and human secretin were found to be functionally interchangeable. Of course, he could have guessed that from the fact that porcine secretin was used in humans for years to produce the same effect as human secretin. Think about the "good old days" when diabetic people used porcine or bovine insulin. The few amino acid differences didn’t change the function of the insulin, although they did lead to a few people developing antibodies to bovine insulin.
On more thing to ponder before you go off to read Dr. Edelson’s editorial. There are only two manufacturers making secretin these days (in the US, anyway):
Manufacturers of human secretin:
ChiRhoClin – ChiRhoStim (human secretin - $415 per 16 mcg/160 U vial)
Manufacturers of porcine secretin:
Repligen – SecreFlo (porcine secretin - $425 per 16 mcg/160 U vial)
Both products are recombinant – meaning that they are made by bacteria or yeast that contain the gene for human or porcine secretin. Since there is no conceivable reason why Repligen shouldn’t use its "house brand" of human secretin (RG1068) for pancreatic imaging, I wonder if they are positioning themselves for a "replay" of the "secretin-cures-autism madness of a few years ago. Unlike Ferring in 1998, Repligen would be in good position to profit from a resurgent interest in PORCINE secretin.
The Gastrointestinal Issue:
Dr. Edelson is also convinced that his survey of parental impressions is correct about the effectiveness of secretin because the Kern et al (July 2002) study showed that (porcine) secretin was significantly more effective in children with autism AND chronic diarrhea.
Let’s examine this claim, shall we?
The Kern et al study looked at 19 autistic children and was a double-blind, randomized crossover study of a single dose of porcine secretin. Of the 19 children in the study, five (5) had chronic diarrhea. These five (5) children apparently showed more improvement that the others (in whom secretin was no better than placebo).
That’s right – Dr. Edelson is basing his defense of secretin on the results seen in five (5) autistic children with chronic diarrhea (five out of nineteen in the Kern et al study).
Just a few months after the Kern et al study came out, Unis et al published their study of porcine (that’s right – porcine ) and recombinant human secretin in autism. They had eighty-five (85) autistic children in their study (one third received porcine secretin) and concluded:
"No evidence that either biologic or synthetic secretin provided amelioration of symptoms beyond placebo was observed."
"This held true when children with and without gastrointestinal problems were examined separately."
So, a larger study (to be fair, only about 28 received porcine secretin) found no difference, even when looking at children with gastrointestinal problems.
And what about Dr. Edelson’s parent survey?
The parent survey that Dr. Edelson keeps referring to is posted on the ARI website. Parents fill it out and mail, fax or e-mail the form back to ARI. There is no attempt to get a representative sample of parents of autistic children and the "data" are inclusive to the beginning of the survey, several years ago. Here’s what visitor’s to the ARI website see when they look at the survey’s assessment of secretin (dated February 2008):
Intravenous secretin (468) Got worse: 7%; Got better: 44%; No change 49%
Transdermal secretin (196) Got worse 10%; Got better: 37%; No change 54%
To "help" the parents in their assessment of the various treatment options listed, the survey gives a ratio of the number of children who "got better" to the number who "got worse" - this completely ignores the children who had "no change", which is often a large number. Now, Dr. Edelson’s better:worse ratio makes secretin look like a magic bullet, with a better:worse ratio of 6.3 for intravenous secretin and 3.6 for transdermal secretin.
However, if we look at "better" vs "not better" (i.e. either no change or got worse), the numbers don’t look so rosy: 0.8 for intravenous and 0.6 for transdermal secretin.
As luck would have it, I happen to have saved ARI’s survey results from last year:
IV secretin (422) Got worse: 7%; Got better 45%; No change 48%
TD secretin (176) Got worse 10%; Got better 37%; No change 53%
If we use these numbers to "dissect" that past year’s activity, the survey reports from Feb 2007 and Feb 2008 show that, in the course of a year, ARI received reports that after treatment with IV secretin:
3 children got worse
3 children got better
39 children showed no change
This is about what you’d expect from a treatment that doesn’t work.
What I find particularly disappointing is that Dr. Edelson has a PhD in psychology and should know that his survey results are meaningless. He should also know how to read the scientific literature and interpret the data. There are all of these things that he should know , and yet he acts as though he was unaware of them.
I’ll let you draw your own conclusions about why Dr. Edelson is trying to breathe life back into this dead hypothesis. As for the validity of his arguments, I think Dean Yeager in Ghostbusters (I) said it best:
"Your theories are the worst kind of popular tripe, your methods are sloppy and your conclusions are highly questionable."
Prometheus
ADDENDUM:
I forgot to mention that Dr. Edelson, at the conclusion of his editorial on secretin, puts out a call for researchers willing to do a study of porcine secretin in autistic children with chronic GI problems. He offers ARI funding, but I doubt that he realizes how expensive such a study would be.
I’d be willing to act as Principle Investigator for such a research project, even though I doubt that negative results would get people to stop injecting (or rubbing) autistic kids with secretin. This passed from a scientific issue to a religious one years ago. Still, there’s nothing I love more than a futile effort in a lost cause.
I happened to mention this idea to the head of the university IRB (the body that approves and monitors human research) and asked her to give me an unofficial opinion on the study. I gave her the available published research and a brief outline of a study design. Her response, which appeared in my e-mail this morning, was that the IRB would not likely approve such a study for the following reasons:
[1] The published research indicates that there is no reason to suspect that secretin would be helpful in the treatment of autism (minimal to zero chance of benefit).
[2] There is a small, but non-zero, risk of harm.
[3] The study population is an "at risk" group (minor and disabled); they cannot give informed consent AND their parents are likely to be willing to accept risks that parents of "typical" children would not.
[4] The proposed research is unlikely to significantly increase the scientific knowledge on the subject. As a result, the risk to the subjects, although it is very small, would exceed the benefit of the knowledge gained.
Filed under: Autism Policy, Autism Practitioners, Myths About Science, Uncategorized | 15 Comments »
How they do the voodoo that they do so well - Part 2
September 19th, 2008
End Games:
Eventually, even the most successful, charismatic “alternative” practitioner will have a patient who doesn’t improve enough to satisfy the parents. Not only are these parents a real drag on the “alternative” practitioner’s ego, there is the very real chance that they might start to talk about how “the Emperor has no clothes”. For those situations, there are a number of strategies that are typically used.
Did you follow my instructions to the letter?:
One of the oldest dodges in the “alternative” medicine “biz” is to prescribe a regimen of treatment that is too complicated for most patients to follow. If they get better (by chance), then it was due to the “treatment” – if they don’t get better….well, they didn’t follow all of the instructions exactly, did they?
Much the same is happening in “alternative” autism therapy. One of the first chelation regimens promoted for treating autism required that the parents give their children a dose every four hours around the clock for two weeks. This meant waking the child up in the middle of the night – every night – for two weeks and getting them to drink a foul-smelling liquid.
The parents were cautioned that missing a single dose – or being late by more than two hours – meant risking having more mercury deposited in the brain. This – needless to say – was absolute nonsense. But no parent who failed to see the promised results could honestly say that they had given every dose on time.
Likewise, a parent who returns to the “alternative” practitioner and complains that the promised “recovery” has not happened will have to answer the same question: “Did you follow all of my instructions?”
Too little, too late…:
Another common retort of the “alternative” practitioner when faced with failure is to complain that the patient was brought to them too late. “If you had only come to me earlier.”, they will say. “The treatment is more effective on younger children.”
A variant of this excuse is to blame the parents for not being willing – or able – to do more therapies. “If you had been willing to try ABC and XYZ as well, he would be better by now.” This is the reason – consciously or unconsciously – that “alternative” practitioners will propose so many possible “therapies” at the start; the parents can’t possible do them all, which gives an easy “out” if (when?) the results aren’t as promised.
And if that doesn’t work…:
Since there are new “alternative” therapies coming out every week, the parents who aren’t happy with the progress of their autistic child can always be shunted onto another treatment “track”. “Chelation and mega-vitamin therapy not working? Try HBOT!”; “HBOT a bust? Try Valtrex for persistent measles virus!” [note: Valtrex/valacyclovir has absolutely no effect on the measles virus – it can’t, since it targets an enzyme the measles virus doesn’t have]
If shunting to different therapies doesn’t work, the “alternative” practitioner can always shunt the patient to an entirely different practitioner. This will almost always be another “alternative” practitioner, as a “real” doctor might say nasty things about the treatments the child has been subjected to – “alternative” practitioners rarely say nasty things about each other (see: “Glass houses, throwing stones and”).
There are none so blind…:
A particularly brazen tactic I have heard some parents discuss is for the “alternative” practitioner to contradict the parents and insist that the autistic child actually has improved. You’d think this would be a violation of the “parents know the most about their child” dogma, but it just shows how “flexible” that piece of dogma really is.
In this scenario, the practitioner confronts the parents who complain about the “lack of improvement” by saying something like, “Oh, but he/she has improved! You don’t see it because you are with him/her every day, but it’s readily apparent to everybody else!” Sadly, many parents probably buy this line, simply because is has the ring of truth. After all – as I’ve discussed above – autistic children do improve, even if you do nothing to/for them. If the parents think back, they’ll have noticed some improvement - especially if their “alternative” practitioner insists that they do.
Of course, it would be equally valid for the practitioner to pull out the medical record and show the parents the growth chart (they do keep a growth chart, don’t they?). They could show the parents the chart and say, “See, he was 95 cm tall when I saw him at three years and now he’s six and he’s already 110 cm tall! That’s real, measurable progress and all due to my treatments!”
[note: for those who don’t have a growth chart on their refrigerator door, those heights correspond to the 50th percentile at three years and below the 25th percentile at six years]
The scary thing is that at least some of the practitioners who have argued with parents over a lack of improvement truly believe that the child really has made significant improvements as a direct result of their “therapies”.
Heads I win; Tails you lose:
One of the best parts about being an “alternative” medical practitioner must be the ability to just make it up as you go along. For example, if a patient shows improvement after trying the “alternative” therapy, it was the therapy that made them better – score! If they get worse…..it’s the “toxins” coming out – score! It’s a win-win world – at least for the practitioner. There are a lot of variations on this theme, but they all share a common feature: no matter what is happening to the patient, it’s a sign that the therapy is working.
Like a lot of the pseudoscience in “alternative” medicine, this one has a grain (64.8 mg) of truth (fact) at its core.
Back in the early days of antibiotic therapy, doctors noted that people being treated for syphilis would often suffer from fever, chills, muscle aches, headaches and worsening skin lesions (in secondary syphilis) immediately after starting the antibiotics.
Two of these doctors – Dr. Jarisch and Dr. Herxheimer – discussed these reactions in papers they published,
[Jarisch A. Therepeutische Versuche bei Syphilis. Wien Med Wochenschr (1895) 45: 721–42. ; Herxheimer K, Krause D. Ueber eine bei Syphilitischen vorkommende Quecksilberreaktion. Deutsch Med Wochenschr (1902) 28: 895–7. ]
leading to the phenomenon being called the “Jarisch-Herxheimer reaction” (sometimes shortened to the “Herxheimer Reaction” or, worse yet, “herx”). Readers familiar with German will note that the article by Dr. Herxheimer is discussing a reaction seen after treating syphilis with mercury. This might account for number of “alternative” practitioners who claim to see a “Herxheimer reaction” while chelating for mercury, but I doubt that many of them have actually read the paper.
The Jarisch-Herxheimer reaction is also seen during treatment of Borrelia infections (Lyme disease and tick-borne relapsing fever), Coxiella infections (Q-fever), typhoid fever (Salmonella enterica serovar Typhi) and trichinellosis (a parasitic worm). It is caused by the rapid release of endotoxins from the bacteria (or parasitic worms) when they die from the antibiotic.
[Note: this reaction is due to inflammatory cytokines secreted in reaction to the sudden release of endotoxins, so "boosting" the immune system would only make the reaction worse.]
Anyway, it’s important to note that the Jarisch-Herxheimer reaction has not been noted during treatment of fungal infections (which would include “yeast”), despite the myriad references to “Herxheimer reaction” or “herxing” (shudder!) during “alternative” treatments of “yeast”.
Also, the symptoms of the Jarisch-Herxheimer reaction are similar to a bad “cold” or influenza-like illness (apart from the worsening of syphilitic skin lesions). It does not include the many fanciful symptoms that are often attributed to it by enthusiastic but poorly-educated “alternative” practitioners (and their fans).
Of course, a simple way around the limitations of the Jarisch-Herxheimer reaction is to simply avoid the term. Many “alternative” practitioners simply attribute any untoward symptoms (or lack of improvement) to “the toxins coming out”. Thus, if an autistic child shows a worsening in their behaviors after starting an “alternative” therapy, it’s “the toxins coming out”. If they develop a rash, lose their appetite, turn sickly yellow, suffer vomiting and diarrhea or collapse into a stupor….it’s “the toxins coming out”.
It’s a great system – if the patient gets better, it’s a sign that the “therapy” is working; if the patient doesn’t get better (or even gets worse), it’s a sign that the therapy is working.
Heads I win; tails you lose.
When in Doubt, Blame the Yeast:
[Note: "yeast" is placed in inverted commas because the term is usually used by "alternative" practitioners to mean Candida albicans – a specific fungus. However, the term "yeast" actually does not refer to a specific organism or even a genus. "Yeast" are simply single-celled fungi – it is a growth type, not a phylogenetic description.]
“Yeast” seems to be a popular scapegoat for “alternative” practitioners, although some hedge their bets by blaming “dysbiosis”, which has the same effect without tying them to a specific organism (or group of organisms). The obvious advantage to “yeast” is that they are ubiquitous – every body surface has some amount of fungal colonization or contamination, including the surface we refer to as our gastrointestinal tract. If you culture a stool sample, you can pretty much bet on growing “yeast” unless you do something to prevent it. “Real” doctors diagnose yeast overgrowth in the gastrointestinal tract (which does happen, but rarely) by microscopically examining the stool, looking for large numbers of fungal cells - not by trying to get “yeast” to grow out of a stool sample.
My favorite “yeast” quote comes from an audiotape of a DAN! “conference” made in – I believe – 2000. On it, a DAN! founding father (I’ll let him remain anonymous) makes the following statements:
“I test every autistic child for yeast. If I don’t find any yeast, I treat them for it, anyway.”
As silly as that may sound, he is just putting into words what many “alternative” practitioners express through their actions: yeast is always present (even if we can’t find it) and it is always a problem.
Reading through the material put out by various “alternative” practitioners, as well as the parents’ reports of their conversations with “alternative” practitioners, it becomes clear that “yeast” is also widely used to “explain” why therapies don’t work. Thus we hear:
“The [therapy] can’t work until we clear up the yeast (or “dysbiosis”).”
“He/she gets worse after [whatever] because it stirs up the yeast.”
“The [symptom] happens because the [therapy] makes the yeast worse.”
“The [therapy] was working until [event] caused his/her yeast to flare up.”
The list is endless, but the examples above should give you the idea. The bottom line is that - at least in “alternative” medicine - anything can be blamed on “the yeast” (or “dysbiosis”). This is because there are no agreed-upon signs and symptoms of “dysbiosis” or “yeast overgrowth”, as these terms are generally used by “alternative” practitioners. Any sign, any symptom can - in the eyes of the “alternative” practitioner - be a sign of “yeast”. And since there is thus no limit to what you can blame on “the yeast”, it has become a universal scapegoat.
Discussion:
I’ve probably omitted a number of gambits used by “alternative” practitioners, so feel free to bring up your “favorites” and we can discuss them in the comment section.
I also want to take this chance to reiterate my hopelessly naive belief that the majority of “alternative” practitioners are truly convinced that they are doing a valuable service to autistic children and their parents. I feel that most of them are honest (but mistaken) and sincere (but gullible) in their belief that their “therapies” are helping “recover” autistic children.
Which leads us to a topic that I have been pondering for some time:
The Semantics of “Recovery”:
I’ve noticed that the “alternative” autism therapy “community” has begun to settle on the term “recovered” to describe autistic children whose signs and symptoms of autism have either moderated or resolved. For the most part, this may be no more than people following a “fad” in the language they use to describe their children. It may also be a reaction to skeptics mocking their claims of a “cure”.
However, whatever the reason, the word “recovered” carries some implied meanings that are worth considering.
I’m ”well” again:
In the most obvious meaning of this usage of “recovered”, it implies that someone was previously “well”, became “sick” and is now “well” (or “better”) again. This is the meaning we use when we say that someone has “recovered” from “the flu” or has “recovered” from surgery. The deeper implication - as it pertains to describing autistic children - is that these children were previously “not autistic”, became autistic for some reason and now are “not autistic” (or “better”) again.
This ignores (perhaps deliberately) the very real possibility that these children were autistic from birth, and therefore can’t be said (even if they are “not autistic” now) to have “recovered”. You cannot “recover” to a condition you never before experienced. If someone is born missing a heart valve and they receive an artificial valve, you cannot say that their heart has “recovered” - it has been “fixed” or some other similar term, but it can’t have “recovered” because it never had that valve to start with.
At some level - possibly unconsciously - the people describing their autistic children as “recovered” are denying the possibility that their children were born with autism. For those people, the autism is something that was imposed upon their previously “well” (or “normal”) child.
I’m back:
Another meaning of “recover” that may be applicable here is in the sense of getting back something that was lost. People “recover” lost property, lost dignity and lost children. This meaning also plays into the mind-set of autism as something that was “done to” a previously normal and healthy child. Many parents of autistic children - particularly those involved in the “biomedical” treatment of autism - have long talked about “getting back” their children.
In both of these meanings, using the word “recovered” makes it linguistically impossible to include the idea that an autistic child may have been “that way” from (or before) birth. “Recovered” implies that the child was “healthy” and was then made autistic.
The implication that autism was imposed on a previously “normal” child leaves open the possibility that someone is to blame. And if someone is to blame, then there is “someone” to be angry at and someone to potentially pick up the tab for the treatments and special schools and special diet…. you get the picture. On the other hand, if autism is an integral part of the child at birth, then there is no focus for the anger and nobody to pay the bills.
Inside the “Shell”:
For years, I have heard parents talk about trying to “break through the shell” and find the child they know is “trapped” inside “the Hell of autism” (or other such phrases). At some point, I realized that “trapped” child they were talking about was the fantasy child that all parents-to-be create before the real child is born.
Eventually, all parents have to give up that fantasy child and live with the child they actually have. Few children live up to all of the aspects of their parents’ fantasy child; those who do may be the worse off for having done so. For some parents - especially those with disabled children - it is very difficult to reconcile the differences between the child they thought they would have (some say “deserved” to have) and their actual child. Some parents, sad to say, never let go of the fantasy child - and some of them will ignore, neglect or even abuse their actual child because it does not meet their expectations.
I am concerned that some of the parents who doggedly pursue “alternative” treatments for their autistic children are - consciously or unconsciously - willingly and knowingly risking harm to their actual child in the hopes of finally getting their fantasy child. They - again, consciously or unconsciously - do not value the child they have because they see it as “just a shell” that is keeping them from having the child they expected to have. What would those people do differently if they knew - or even suspected - that the child they see before them is not a “shell” and that there is no “normal” child “trapped” inside?
What would they do differently if they thought that there was no “lost child” to “recover”?
That’s what makes words so powerful.
Prometheus
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