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When High Does Mean Low: Autism, mHBOT, and Dan Rossignol

7 Oct

A while back on Autism Street, I questioned the claim by DAN! doctor, Dan Rossignol, that children he wrote about in an article that appeared in the pay-to-publish, not peer-reviewed journal Medical Hypotheses, were treated with “mild hyperbarics” at 1.3 ATA.

In hyperbaric medicine, the term “1.3 ATA” has the very specific scientific meaning of “1.3 Atmospheres Absolute”, and it is a likely overstatement (due to rounding) of the actual treatment pressure in that particular study. Put simply, “atmospheres absolute” refers to the total pressure, and includes that actual pressure of the atmosphere. It’s also an absolute pressure that is apparently beyond the physical capabilities of the equipment that was used (a Vitaeris 320), unless the chamber were located well below sea-level, or housed inside another, larger, and pressurized hyperbaric chamber. I suggested that he publish an erratum. He was kind enough to reply to my e-mail, in which he responded, in part with:

HBOT measurements are typically reported to 2 significant figures, i.e. 1.3, 1.5, 2.0, 2.4, 3.0 ATA, etc… Therefore, this properly rounds to 1.3 ATA (we did not report the pressure to 3 significant figures as would be the case with 1.30 ATA).

As it turns out, this may not be entirely true. I responded with the following:

At least two of the papers cited in your references (Collet et al., and Montgomery et al.) show treatment pressures of 1.75 atmospheres. There might even be more. Would those have been acceptable to be published at 1.8? Do you think a real peer-reviewed journal would be requiring that you publish an erratum? I think so, but I could be wrong. In many of the “typical” numbers you list, reporting to 2 significant figures does not change the accuracy anyway (2.0 ATA is stated instead of 2.00 ATA, 3.0 ATA instead of 3.00 ATA, etc.).

Dr. Rossignol, to my knowledge, did not publish an erratum. He did not comment on the apparent overstatement of treatment pressure further. So it would appear that he intends to stick with his assertion that,

HBOT measurements are typically reported to 2 significant figures, i.e. 1.3, 1.5, 2.0, 2.4, 3.0 ATA, etc…

That’s fine, we can work with that, but remember it. It’s going to be very important in a minute.

I later wrote a little more about the physics of so-called “mild hyperbarics” again, and included a notation of a new study that Dr. Rossignol, appeared to be working on.

There’s another “hyperbaric therapy as a treatment for autism” study underway. It appears to be headed up by Dr. Rossignol, and has three clinical locations supervised by Doctors Liz Mumper (Virginia), Cindy Schneider (Arizona) and Jeff Bradstreet (Florida) – none of which appear (according to a search at ABMS) to have board certification in Developmental-Behavioral Pediatrics, Child Neurology, Neurodevelopmental Disabilities or Undersea & Hyperbaric Medicine.

Well, it looks as though that study has wrapped up. Is there a forthcoming publication that will claim that the children in the study were treated with “mild hyperbarics” at 1.3 ATA? Will it be published in a journal like Medical Hypotheses, JAPandS, or Medical Veritas? If it’s headed for a respectable peer-reviewed medical journal, and the treatment pressure is claimed to be 1.3 ATA, there might be a problem.

You see, in the real world, a Vitaeris 320, is probably not a hyperbaric chamber that can produce a full 1.3 Atmospheres Absolute – even at sea-level. Its non-rigid construction means that it’s directly influenced by the ambient atmospheric pressure. To calculate the absolute pressure inside the chamber at any given time doesn’t require anything more than knowing the current actual atmospheric pressure outside the chamber, and the slight pressure added by the compressor that inflates it. Although it does vary slightly, at sea-level the average atmospheric pressure is about 14.696 PSI. According to the manufacturer’s spec sheet, the chamber introduces an operating pressure of 4 PSI, which would yield a total pressure of about 18.696 PSI – 1.27 ATA. Don’t forget, that’s at sea-level!

The study mentioned above, lists the following clinical trial locations:
Phoenix, Arizona
Melbourne, Florida
Charlottesville, Virginia
Lynchburg, Virginia

Are all of those cities at sea-level? No.

Will this matter? Absolutely.

It’s a simple fact of physics that as elevation increases, atmospheric pressure decreases. Although there are several influencing variables involved, this is probably most easily understood in layman’s terms by knowing that weight of the column of air above you gets smaller as your altitude increases (as you ascend, the column above you is shorter and simply weighs less – exerting less pressure).

So what does this mean for this study? It means that if the study used Vitaeris 320 chambers, and reports that children were treated with 1.3 Atmospheres Absolute, it should raise more than a few eyebrows.

Firstly, if the study does not report actual atmospheric data for pressure at the study locations during treatment, it will be incomplete. Remember, for a non-rigid chamber, treatment pressure is measured by adding the actual ambient pressure to the pressure added by the compressor used to inflate the chamber. There is no way to measure the actual treatment pressure without knowing the actual ambient atmospheric pressure at the time of treatment.

Side note: It could be tempting for one to read a weather report from the National Weather Service in the U.S. and simply think that the pressure reported is the actual ambient atmospheric pressure at the study location (station pressure). Unfortunately, that’s not how it usually works. The National Weather Service typically reports “altimeter pressure” and “sea-level pressure”. See section 11.6, Table 11-2 from the Federal Meteorological Handbook No. 1. These adjusted pressures (corrected for elevation and temperature) are done to make pressure systems on weather maps more meaningful (and not simply reflective of the topography), and to allow aircraft pilots to adjust their instruments to the current conditions. With an altimeter calibrated to what the pressure “would be” at sea-level, instruments can accurately reflect the actual altitude of the plane. This is important if you intend to land on a runway that is always 1135 ft. above sea-level.

Secondly, if the study does not claim to have “measured” the treatment pressure, but instead asserts that it is 1.3 ATA, it will be difficult for any publication to substantiate the claim that the treatment pressure was uniformly (or even approximately) 1.3 Atmospheres Absolute at all study locations, due to the varying elevations of the study locations.

Let’s use Phoenix, Arizona (one of the study locations) as an example. The elevation of Phoenix, Arizona is approximately 1135 ft. above sea-level. This means that the ambient atmospheric pressure is about 14.10 PSI simply due to the elevation. 14.10 PSI plus an added 4 PSI gives us a total of 18.10 PSI – 1.232 ATA! Using Dr. Rossignol’s statement,

“HBOT measurements are typically reported to 2 significant figures, i.e. 1.3, 1.5, 2.0, 2.4, 3.0 ATA, etc…”

1.232 ATA in Dr. Rossignol’s words, “properly rounds to” 1.2 ATA!

Will the study report this? Or will it claim a very unlikely (if not impossible) treatment pressure of 1.3 Atmospheres Absolute? Following Dr. Rossignol’s apparent rounding preferences, we’re talking about a potential overstatement of the pressure added by the hyperbaric chamber of 50% for Phoenix alone. The Lynchburg, Virgina study location will quite likely present similar problems (elevation 938 ft. above sea-level) for Rossignol’s work. Is Dr. Rossignol, really concerned about the accuracy of the science in his work? We might just find out soon enough.

For anyone interested, here’s a table of estimated total pressure provided by a Vitaeris 320 at selected U.S. cities. Keep in mind that these estimates reflect the manufacturer’s specification of 4 PSI of operating pressure, and the expected atmospheric pressure due to elevation alone, and do not account for the slight variations in the weather. (Elevations retrieved from Airnav.com).

Estimated total pressure provided by a Vitaeris 320 at selected U.S. cities

It’s no surprise that parents of autistic children who “believe” that “mild hyperbarics” will somehow provide benefit for autism itself, would seek insurance reimbursement. In fact, some may interpret a statement by Dr. Rossignol to express such a view:

One of the reasons we wanted to study the 1.3 ATA chambers is because this is something that is available at home. We hope that if it does work and is proven, we can begin to have insurance reimburse for hyperbaric and this is one of our goals, as well.

Source

Besides the obvious problem that scientifically “proving” that treatment with “1.3 ATA” will be difficult with chambers that likely don’t provide 1.3 Atmospheres Absolute, what are insurance companies supposed to think? Would insurance companies like the idea of reimbursing for HBOT treatment at a specific pressure that really isn’t?

Epidemic or greater awareness?

4 Oct

OK, this one has been beaten to death. I am amazed that it still think that there is evidence of an “epidemic”. This is especially true of those who rely on the California Department of Developmental Services (CDDS) data. These data are so muddy as to be able to hide a real increase or a real decline.

These data have severe limitations as noted before on this blog. They are not “epidemiological” data. They are not a census of those with autism in California. They are a count of who is getting services and this can and does vary dramatically over time and geography.

1984 Birth CohortThat said, let’s take a look at how service rates change with time for a given birth cohort. (click to enlarge). [edit: this is the 1984 cohort] This is much as you would expect. Kids start being listed at age 3. The number increases year after year until a plateau is reached. This happens at about age 7 or 8. There is some slope to the curve: additional kids are being added to the roll even after 8 years old.

This is very straitforward and expected. But, what happens over a longer time to this cohort? Click to enlarge this graph.1984 Birth Cohort CDDS Data Ignoring the obviously leading arrow and label for now, it is abundantly clear that something unexpected has happened. A second large increase in the number of clients is observed. Why would this happen? Well, one of the possible explanations is shown by the arrow. In 1997, the “epidemic” was declared. Autism awareness increased dramatically.  One possibility is that the 1984 cohort was still in school where people might notice them and identifiy them. This cohort nearly doubled in numbers from 1997 to 2003. 

This brings up so many questions, many of which we just can’t answer with the data we have access to.

It would be interesting to see if there was substitution. Were these kids (heck, teenagers) listed by CDDS under a different label?

How did roughly half the kids in this cohort avoid detection? I think the new phrase is “it’s like missing a forrest fire”. Well, these forrest fires were blazing for 13 years before people started noticing them.

Also, what happened to other cohorts? Well, for one thing, a similar jump in cohort size around 1997 is observed for birth years in the 1980’s and early 1990’s. It isn’t as clear or as consistent birthyear-to-birthyear as you go back in birthyears, but it is observable in some birth cohorts. One example where one can see this is the 1960 birth cohort, which increased about 15% around year 2000.

That last paragrah wasn’t clearly written, I admit. But if you are thinking, “what? The CDDS ‘found’ 15% more 40 year olds?” you read it right.CDDS clients by year as listed in 1986 and 2007 This graph (click to enlarge) shows the number of CDDS autism clients as listed in 1986 and 2007 by birth year. The 1986 (in black) data are the same as shown before. The drop in the client count in the early 1980’s is an artifact: those kids weren’t identified yet in 1986. The 2007 client count (in red) show something very interesting, at least to me.

There is an increase in autism clients for almost all the birth year groups. 40-year olds, 50 year-0lds, even older people were added to the client list as “autistic”. Again, we don’t know if or how these people were classified before the “epidemic”. They could have been (and likely were, in my opinion) clients listed in another category in 1986.

Let’s take a look at the difference between these two curves. I included data for people with birthdays in the early 1980’s, but these are not reliable. Those people weren’t through the first round of identification by 1986. 

CDDS Autism Clients in 1986 and 1997 by birth yearThe graph shows the difference as a percentage increase. This allows us to see the older cohorts easier. At the same time, it allows people to accuse me of doctoring the data to make it seem like a bigger effect than it really is. That would be an obvious way to try to divert attention from the fact that the “epidemic” caused a roughly 40% increase in CDDS autism clients born in the 1960’s. For those clients born from 1940-1955, the increase was 70+/-28%.

Think about that a second. Autism amongst forty year old people increased by 70% during “the epidemic” years.

How can this be? How could CDDS have missed people with autism for forty or fifty years? Sure, some of these people may have moved into the state. Some of them may have been cared for by family and not been served by CDDS. The trends of these birth cohorts with time do not show the sharp rise in the late 1990’s as observed above for 1980’s cohorts.  For me, this is suggestive that the those who could be identified in the school systems, were.

Obviously there are a lot of open questions here.  How and why these increases were observed is a big question.  Why no one has seen fit to mention this before is another question.  The CDDS did not create these data sets for me.  Someone else has been paying for that for some time, according to Mr. Kirby…who also hasn’t mentioned this.

People keep saying, “you can’t have a genetic epidemic”.  Well, you can’t have an epidemic of a childhood onset “disease” in forty-year-olds either.

____________________________________________

Edit: 

CDDS Clients vs. year for multiple birth cohorts First, note that the birth cohort in the first figue above is from 1984.  That is not clear.  Second, here is a graph with multiple cohorts.  Note that all the cohorts have an upswing in the client-numbers in the late 1990’s.  Even the 1990 cohort does this.  It does not appear to be based on age, but on calendar year.

A bad day for antivaccinationists: Yet another study fails to support an association between vaccines and neurodevelopmental disorders

30 Sep

This blog entry first appeared at Respectful Insolence. It is reproduced here with permission.

A bad day for antivaccinationists: Yet another study fails to support an association between vaccines and neurodevelopmental disorders
By Orac.

I’m almost beginning to feel sorry for the mercury militia.

Think about it. They’ve been claiming for the past several years that the mercury in the thimerosal used as a preservative in childhood vaccines is a cause of autism. If you believe Generation Rescue, A-CHAMP, SAFEMINDS, and various other activist groups, vaccines are the root of all neurodevelopmental evil, culminating in what to them seems to be the most evil of evil condition, autism. Yet, in study after study in the new millennium, no correlation has been found to implicated their favorite bte noire thimerosal, which serves as a surrogate for their general dislike of vaccines in general.

It comes as no surprise, then, that A-CHAMP would want to launch a pre-emptive strike against a large study of thimerosal-containing vaccines that was published in the New England Journal of Medicine today. Blazing out of their website is the headline New CDC Study Falsely Claims Thimerosal is Safe

On September 27, 2007 the New England Journal of Medicine will publish a study entitled, “Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years.” For more than two years we at A-CHAMP have been hearing rumors of a new study that “exonerates” thimerosal, despite the fact that the study results were supposed to be kept strictly confidential.

Now the rumors have been turned into hype – another government funded study that tries to spin data and clear thimerosal of any suspicion of causing neurodevelopmental disorders. The study authors claim in their “Conclusions” that “[o]ur study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and neuropsychological functioning at the age of 7 to 10 years.”

The statement is plainly false. The study’s conclusions do not reflect the study’s data or the limitations of the study,

You’d think that at least A-CHAMP would correct that hanging comma at the end of the sentence there.

Sarcasm aside, the study’s conclusions do reflect the study’s data, quite well, as we will see, and A=CHAMP’s complaints boil down to the usual crank technique of cherry picking the evidence, combined perhaps with sour grapes. Let’s lay the abstract out for all to see before we look at A-CHAMP’s individual points:

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
William W. Thompson, Ph.D., Cristofer Price, Sc.M., Barbara Goodson, Ph.D., David K. Shay, M.D., M.P.H., Patti Benson, M.P.H., Virginia L. Hinrichsen, M.S., M.P.H., Edwin Lewis, M.P.H., Eileen Eriksen, M.P.H., Paula Ray, M.P.H., S. Michael Marcy, M.D., John Dunn, M.D., M.P.H., Lisa A. Jackson, M.D., M.P.H., Tracy A. Lieu, M.D., M.P.H., Steve Black, M.D., Gerrie Stewart, M.A., Eric S. Weintraub, M.P.H., Robert L. Davis, M.D., M.P.H., Frank DeStefano, M.D., M.P.H., for the Vaccine Safety Datalink Team

Background It has been hypothesized that early exposure to thimerosal, a mercury-containing preservative used in vaccines and immune globulin preparations, is associated with neuropsychological deficits in children.

Methods We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.) Exposure to mercury from thimerosal was determined from computerized immunization records, medical records, personal immunization records, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We assessed the association between current neuropsychological performance and exposure to mercury during the prenatal period, the neonatal period (birth to 28 days), and the first 7 months of life.

Results Among the 42 neuropsychological outcomes, we detected only a few significant associations with exposure to mercury from thimerosal. The detected associations were small and almost equally divided between positive and negative effects. Higher prenatal mercury exposure was associated with better performance on one measure of language and poorer performance on one measure of attention and executive functioning. Increasing levels of mercury exposure from birth to 7 months were associated with better performance on one measure of fine motor coordination and on one measure of attention and executive functioning. Increasing mercury exposure from birth to 28 days was associated with poorer performance on one measure of speech articulation and better performance on one measure of fine motor coordination.

Conclusions Our study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.

It’s noted that a similar study looking at autism will be published next year. Of course, the fact that this study didn’t look at autism leaves the antivaxers a huge opening to say, “Well, yes, but you didn’t look at autism.” Never mind that there are now several studies that did look at autism and found no association between thimerosal-containing vaccines and autism. So what are the main complaints that A-CHAMP has about this study? Let’s take a look, starting with the first one:

The Study’s Claim of No Causality is Contrary to the Study’s Data. The study authors claim that the data disproves causality when in fact, several findings show a negative effect on neuropsychological functioning warranting more study. At least one such adverse association was also found to be associated with low dose thimerosal exposure in other studies. As with earlier studies hyped by vaccine promoters, the study is unable to prove or disprove causality. The blanket dismissal of the troubling neuropsychological outcomes in this study is disingenuous and misleading.

First off, the study didn’t claim that there was “no causality.” What it stated is exactly what you see in the Conclusions section: That the study does not support a causal relationship. There’s a difference there too subtle for the ideologues who wrote this press release to understand. It’s impossible ever to prove “no causality.” It is, however, possible to conclude from the data that the data does not support a causal relationship. Second, A-CHAMP is cherry picking associations here. It is true that there were some negative correlations found that achieved statistical significance. When running 42 tests, it would be shocking if there were not a few anomalous findings. What makes the study authors fairly confident that the findings are anomalous is that they were divided roughly equally in both directions, good and bad. Consequently, if A-CHAMP is going to insist that the correlation, for example, with increasing mercury exposure and poorer performance on the GFTA-2 measure of speech articulation test, then it must also accept the findings of a beneficial association between mercury and identification of letters and numbers on the WJ-III test, as there is no reason to reject it. Naturally, the mercury militia picks on the associations as being true that they want to be true and ignore the other associations, which, if true, would be arguments for including thimerosal in vaccines. It’s far more likely that all of them are just noise. Again, the reason that investigators can reasonably conclude that the associations found are most likely due to random chance is because of their random distribution between positive and negative.

Another complaint:

Children with autism were excluded from this study. The early media contacts we have received suggest that this study shows no association between thimerosal and autism. In fact, the study specifically did not look at children with autism as the sample size was too small and the testing is impossible to complete for the typical child with autism. The exclusion of children with autism from the study may have undermined the power of the study to draw any conclusions about thimerosal.

This is a really, really dumb statement. I’m sorry, but there’s no other way to put it. It just is. It’s like criticizing an apple for not being an orange. The explanation for this is right in the paper, “Since the CDC is conducting a separate case-control study of autism in relation to mercury exposure, a measure of autism was not included in the test battery.” Get it, idiots? A separate study is being done and the results will be reported in a separate paper! That renders this complaint utterly irrelevant. It’s nothing more than a red herring designed to fire up the faithful.

This complaint is not really stupid, but definitely overblown:

The Study’s Methodology has Serious Limitations Negating Any Conclusions Drawn. Major flaws that that causes a large underestimation of neurological adverse effects burden the study: 70% of the families recruited for the study failed to participate. This kind of bias in epidemiological studies is well known to distort even large studies of health effects…It is well established that people who choose to participate in this kind of study are probably very different than those who refuse to participate (the “healthy person” or “complier” effect); especially when the ones who refused to participate said they were too busy.

Simply put: if you have a kid with ADHD or mild ASD or other neurodevelopmental disorders, you are likely to be busier, more stressed, and less available than the mother of a healthy normal child. This phenomenon serves to amplify the effect of the “complier”, the ;healthy families,” – those who do cooperate with the study – confounding or confusing the study’s results. The cooperative parents included in the study were more likely to be those with relatively trouble-free kids

There’s no evidence that this sort of bias existed, and A-CHAMP conveniently omits other biases that might be result from such a selection bias. For example, it is also quite possible to argue that parents who think vaccines may have caused their child’s condition would be even more likely to want to participate in the study (self-selection bias), than parents whose children are normal or who don’t believe vaccines had anything to do with their child’s problems; they might have thought that it wasn’t worth their bother. It’s good of the antivaxers who have been championing the execrable telephone survey done by Generation Rescue to recognize that this sort of bias exists; too bad they only mention it when it suits their purposes (i.e., to trash a study whose results they don’t like) and ignore it when it doesn’t, for example when it calls into doubt the results of the Generation Rescue telephone poll.

In reality, the fact that only 30% of the families who were approached for the study agreed to participate is probably the most significant weakness of the study. The authors don’t try to hide it. Rather, they are right up front with it in the Discussion section, while at the same time pointing out that this is this possible bias was ameliorated by enrolling children on the basis of having received vaccinations without regard to the seeking of health care or having been given a neurodevelopmental diagnosis, as well as noting that many children weren’t enrolled because they couldn’t be located. Moreover, exposure information was obtained from many different sources. It also looked at prenatal exposure to thimerosal-containing vaccinations from vaccines that the mother might have had while pregnant.

Next complaint:

Vulnerable Children Were Excluded from the Study; Early Intervention Was Ignored. Children with a birth weight under 5 lbs. 8 oz. were excluded from the study further skewing the results, as these children are likely more vulnerable to thimerosal than larger babies. In addition, the fact that early intervention may have reduced deficits such as speech delay detected by neuropsychological testing of children aged 7-10 was not accounted for in the study results. There also was no analysis of combined prenatal and postnatal mercury exposures. Only 103 mothers who were exposed to mercury from prenatal immune globulins participated in the study, far too small a group for researchers to draw conclusions regarding the safety of thimerosal in these products.

This is a grab-bag of the specious and semireasonable. The reason for excluding low birthweight children was obvious: Such children are more likely to have neurodevelopmental problems completely independent from any external cause, such as thimerosal. Including preemies and lower birth weight children would only contribute to the background noise and make finding true associations more difficult. A-CHAMP should be glad that the investigators did that, given that it was almost certainly done to make the study more likely to find an association between vaccines and neurodevelopmental disorders. In addition, there is no evidence that low birth weight children are “more vulnerable to thimerosal.” Of course, once again, A-CHAMP fails to point out that the authors themselves pointed out the shortcoming in regard to not being able to account for interventions such as speech therapy. As for the whining about not analyzing combined prenatal and postnatal mercury exposures, that’s just a red herring; the study did test an a priori assumption of interaction between pre- and postnatal mercury exposure.

The rest of the complaints are the standard ones: Conflict of interest, for example, because several of the study’s authors had received funding from pharmaceutical companies. These potential conflicts of interest are clearly stated in the study. A-CHAMP also brings up a totally specious complaint of the study supposedly not accounting for “efflux” disorder (i.e., children who are allegedly “poor excretors” of mercury). Fortunately, Prometheus has provided a good explanation of what a crock that whole myth is, so that I don’t have to.

Of course, there is another reason, besides this study failing to show what the mercury militia wants it to, that there is such hostility here:

The politicization of the thimerosal issue has led researchers to take unprecedented measures. Unlike previous studies, the current study included more than a dozen outside consultants, including at least one advocate for families of children with autism. “We have really tried to make the entire process–from experiment design to manuscript review–as transparent as possible,” says Thompson. But that effort may not have made a difference in the long run. Sallie Bernard, executive director of Safe Minds, a nonprofit parents’ organization that focuses on the role of mercury in neurodevelopment disorders, consulted on the study but still takes issue with its findings. “All the studies, including this one have certain limitations in their design and their methodology,” she says.

Sour grapes, anyone? Ms. Bernard was a consultant on this study and helped contribute to its design! She apparently didn’t like the results that it was producing and decided to drop out and start criticizing it–even jumping the gun on the 5 PM embargo yesterday to do so! Indeed, she is listed on the study in a way that I’ve never seen before: as a “dissenting member.”

How many studies by mercury militia enablers Mark and David Geier include even a note of dissent?

Although this study is not without flaws, it nonetheless does not support a correlation between thimerosal-containing vaccines and the neurodevelopmental problems studied. Even better, the New England Journal of Medicine included two editorials along with the story. One editorial discussed the explosion of vaccine litigation that the now discredited thimerosal “hypothesis” has unleashed, immune to the findings of science. The second editorial is by Paul Offit (the Antichrist to antivaxers) and makes an excellent point about the unintended consequences of taking precautionary measures on the basis of little or no evidence:

On July 9, 1999, after much wrangling, the CDC and AAP decided to exercise the precautionary principle. They asked pharmaceutical companies to remove thimerosal from vaccines as quickly as possible; in the interim, they asked doctors to delay the birth dose of hepatitis B vaccine in children who weren’t at risk for hepatitis. A press release issued by the AAP revealed the ambivalence among its members: “Parents should not worry about the safety of vaccines,” it read. “The current levels of thimerosal will not hurt children, but reducing those levels will make safe vaccines even safer. While our current immunization strategies are safe, we have an opportunity to increase the margin of safety.” Critics wondered how removing something that hadn’t been found to be unsafe could make vaccines safer. But many parents, frightened by a sudden change in policy, reasoned that thimerosal was targeted because it was harmful — and their faith in the vaccine infrastructure was shaken. Doctors were also confused by the recommendation.

I could see how that would confuse parents and doctors. Offit concludes:

Despite several years of reassuring studies, the thimerosal controversy continues to be emotionally charged. Physicians, scientists, government policy advisors, and child advocates who have publicly stated that vaccines don’t cause neurologic problems or autism have been harassed, threatened, and vilified, receiving hate mail and occasionally death threats. The CDC, in response to planned protests at its gates, recently beefed up security and instructed personnel about how to respond if physically attacked.

During the next few years, thimerosal will probably be removed from influenza vaccines, and the court cases will probably settle down. But the thimerosal controversy should stand as a cautionary tale of how not to communicate theoretical risks to the public; otherwise, the lesson inherent in the collateral damage caused by its precipitous removal will remain unlearned.

Exactly. With the best of intentions, trying to be as “safe” as possible, the AAP and CDC unleashed a tsunami of fear of vaccines and laid the groundwork for pseudoscientists like Mark and David Geier to stoke the fears of mercury further with badly designed studies. This was an example of framing science at its worst.

In the end, it is always frustrating to watch how such studies are spun by antivaccinationists. Epidemiology is like that, though. It’s virtually impossible to conduct a cohort study like this without permitting significant shortcomings in it. The reason is that, unlike a bench experiment, the investigators can never control all the variables. Trade-offs are inevitably made, and rarely are there adequate resources to assure sample sizes large enough to be bullet-proof or to be able to account for all potentially confounding variables. No one study is ever sufficient to rule out correlations between undesirable outcomes and various compounds. However, as the weight of several studies starts to bear down on the problem, the preponderance of evidence must at some point be accepted, because we do not have unlimited resources to keep doing studies to answer the same question over and over and over again and every repeated study uses resources that could be used to study other potential causes and treatments for autism. This study happens to be one large and convincing chunk of that evidence, but it is not the only one. Coming next year, when the CDC releases a similar trial about autism, will be another. As Dr. Offit said:

In a new study, Thompson and his colleagues are taking another look at thimerosal exposure and autism. But for many, the question has been resolved. “This study is the third one of its kind. When the autism one comes out, it will be the sixth of its kind. They’ve all shown the same thing–that there is no significant correlation,” says Offit. “Meanwhile, the thimerosal question has diverted attention and resources away from the search for more promising leads on what causes autism. How many more studies will it take?”

That’s the difference between science and crankery. If this study had shown a clear and convincing correlation between thimerosal in vaccines and neurdevelopmental disorders, I would have accepted the results and perhaps started to change my mind. On the other hand, for cranks, no number of studies is ever enough to dissuade them from their beliefs. If God Himself were to come down from on high and design the absolutely perfect study, which when carried out showed no correlation between thimerosal in vaccines and neurodevelopmental disorders, the antivaccinationists would insist that it was flawed, that the investigators had conflicts of interest, and that it needs to be repeated until (although they would never admit this) it shows the results they want it to show.

In fact, expect just that. The CDC has pledged to make the raw data available to other researchers. I predict that, within a few months, a study by Mark and David Geier will use their trademark bad statistics and bad math to cook the numbers to make it look as though there are associations between thimerosal in vaccines and neurodevelopmental disorders that the CDC “covered up.”

Just wait.

ADDENDUM: Some more commentary on this study:

From Left Brain/Right Brain:

No, everything was fine and dandy as long as she [Bernard] was enjoying being fawned over as a “representative of the autism community” and a fellow-scientist instead of the commercial marketer she actually is. Here’s a clue, Sallie: If you’re going to play scientist, you have to follow the rules of science, and that means you stand by your results. You don’t get to say “heads I win, tails you lose” by waiting to see the outcome before deciding whether the study was any good.

And you really don’t get to have CDC at your beck and call, spend hundreds of thousands of taxpayer dollars to do a study to your specifications, then turn around and call them liars when you don’t like how it comes out.

And you, CDC? You’re not just a victim here. Every time you say “let’s do more research” or “we are examining this issue” in order to appease the mercury moms, you increase the chances that kids will go unvaccinated because you failed to give their parents confidence in the safety of vaccines. When you say a study is reassuring and then highlight what is virtually certain to have been a chance finding (a statistical association between higher thimerosal exposure and transient tics in boys) without making it abundantly clear that some false associations were inevitable given the study design, you defeat the purpose of doing the study.

From AutismVox:

Safe Minds, whose Executive Director, Sallie Bernard, was an external consultant and dissenting member of the study, put out a press release stating that the new study’s “draws a misleading conclusion.” But this statement is as “misleading” as the headlines cited above are about the study’s actual contents This only furthers the belief that–no matter how clearly it is stated and shown that there is no causal association between early exposure to thimerasol and later neuropsychological outcomes—a link between these has been firmly established in the public mind. And disputing that link will take more studies, more evidence, more efforts, and more self-scrutiny of why we believe what we believe.

From Autism Natural Variation:

The CDC study looked at 42 different outcomes, and determined multiple confidence intervals in each case, since different levels of exposure were tested. In total, I understand there were over 300 confidence intervals. Consequently, assuming the null hypothesis is correct, you should expect that an RR of 1.0 will be outside the 95% confidence interval in over 15 measures. What the study found was that in 12 measures there was an apparent protective factor, and in 8 measures there was an apparent risk factor. This is completely consistent with the null hypothesis. Therefore, the conclusion of the study, namely that the results of the same do not support a causal association between thimerosal-containing vaccines and neurological outcomes, is absolutely the correct conclusion.

From Arthur Allen on The Huffington Post:

Despite the wealth of data showing that vaccines do not cause autism, many parents continue to believe the theory. Jenny McCarthy, an ex-Playboy Bunny and TV personage, has been making the rounds of the media this week (Oprah, ABC, People magazine) to promote her book, in which she claims that her child was made autistic by vaccines but was “recovered” through alternative therapies.

A large CDC study comparing thimerosal exposure rates in autistic and non-autistic kids is due out around this time next year, as is an Italian study of the question. The data will probably duplicate the many previous studies that have shown no effect. The dogs may bark but the caravan moves on. Or is it the other way around

(The comments from die-hard antivaxers after Allen’s post are scary indeed.)

From Derek Lowe at In the Pipeline:

The director of SafeMinds, a group of true thimerosal believers if ever there was, actually was on the consulting board of this latest study. But she withdrew her name from the final document. The CDC is conducting a large thimerosal-and-autism study whose results should come out next year. Here’s a prediction for you: if that one fails to show a connection, and I have every expectation that it’ll fail to show one, SafeMinds will not accept the results. Anyone care to bet against that?

As a scientist, I’ve had to take a lot of good, compelling ideas of mine and toss them into the trash when the data failed to support them. Not everything works, and not everything that looks as if it makes sense really does. It’s getting to the point with the autism/thimerosal hypothesis- has, in fact, gotten to the point quite some time ago – that the data have failed to support it. If you disagree, and I know from my e-mail that some readers will, then ask yourself what data would suffice to make you abandon your belief? If you can’t think of any, you have moved beyond medicine and beyond science, and I’ll not follow you.

Commenting on David Kirby’s truly idiotic take on this study in The Huffington Post, Steve Novella at Neurologica:

What Kirby does is not just really dumb, it’s despicable. He cherry picks all the negative (meaning bad) neurological outcomes and pretends that the study shows a correlation (it doesn’t, when you look at ALL the data). He then tries to dismiss the positive (good) outcomes as absurd. He mockingly writes:

If they (the CDC) really mean that thimerosal increases IQ levels in males, then sign me up for a double-dose flu shot this year.

No, David, they don’t mean that. Not by any stretch of the imagination. It takes incompetent statistical analysis or the blindness of ideology to write something so ridiculous. What the CDC means is that the study does NOT show that thimerosal increases IQ, nor that it causes motor tics, or improve motor skills, or decrease language skills, or anything else. The study showed no correlations because it all averaged out as noise.

Steve, normally polite to a fault even with cranks, seems to be laying down a bit of the old Respectful Insolence(tm). I like it.

Dore pwned in medical journal: expensive and unproven ‘cure’

29 Sep

The Dore programme is an interesting ‘cure’ for all kinds of things: as Dorothy Bishop puts it, “Dore Achievement Centres are springing up world-wide with a mission to cure cerebellar developmental delay, thought to be the cause of dyslexia, attention-deficit hyperactivity disorder, dyspraxia and Asperger’s syndrome. Remarkable success is claimed for an exercise-based treatment that is designed to accelerate cerebellar development.” Sound great, doesn’t it. Except, as Bishop shows in a new journal article, this is not supported by good evidence and it is therefore the case that “the claims made for this expensive treatment are misleading”. While academic journals are normally pretty restrained, this is about as close as I’ve seen to a thoroughgoing fisking in a journal article: Dore, and their research, are really pwned here. Given that – according to Ben Goldacre in the Guardian – a course of Dore treatment costs around £1,700 (and takes a load of time) I’d want much better evidence of efficacy before splashing out.

Dore is certainly well-promoted. Google “Asperger’s Syndrome” and it brings up an advert for Dore’s “Proven Long Term Drug-Free Solution Relieving the Symptoms of Aspergers”. Google “dyspraxia” and an advert informs one about Dore offering a “Proven Long Term Drug-Free Solution Relieving the Symptoms of Dyspraxia”. Google “dyslexia” and an advert promotes Dore as a “Proven Drug-Free, Exercise Based Dyslexia Remedy”. As a slick Dore promotional DVD puts it: “Now Dore Centres are able to offer real hope to those in despair” due to suffering from ‘learning disorders’. This includes Asperger’s Syndrome, which Dore’s UK site describes as “a problem associated with poor social behaviour.” Dore is apparently “suitable for those with high functioning Asperger’s Syndrome and Autism” (are any alternative treatments nowadays not marketed as suitable for people on the autistic spectrum?).

This marketing might make Dore seem appealing. Bishop notes that, “Although most of the promotion of the treatment is based on personal testimonials, these are backed up by research. Dore pointed to a study showing that treatment led to a nearly fivefold improvement in comprehension, a threefold improvement in reading age, and a 17-fold improvement in writing.” Sounds good, right? But the quality of the research was pretty dismal. Among other problems, while the research did include a control group

there were no data corresponding to a time when the treatment group had had intervention and the control group had not – because the control group had embarked on treatment at the end of the first phase. Accordingly, the authors presented the data only from the treated group.

‘Oops’, is all I can say…Bishop puts it more eloquently, making clear that “The publication of two papers in peer-reviewed scientific journal (Dyslexia) has been presented as giving further credibility to the treatment. However, the research community in this area has been dismayed that work of such poor standard has been published.” I wonder how the researchers justified this poor control to Dyslexia – maybe the good old excuse that ‘the dog ate my control group’?

This might sound bad for Dore, but that’s not the half of it – Bishop also takes apart Dore’s posited mechanism of action:

The gaping hole in the rationale for the Dore Programme is a lack of evidence that training on motor-coordination can have any influence on higher-level skills mediated by the cerebellum. If training eye–hand co-ordination, motor skill and balance caused generalised cerebellar development, then one should find a low rate of dyslexia and ADHD in children who are good at skateboarding, gymnastics or juggling. Yet several of the celebrity endorsements of the Dore programme come from professional sports people.

So, aside from lacking a plausible mechanism of action, and lacking good evidence of efficacy, Dore seems like a great idea. If that leaves anyone rushing to get out their cheque book, Bishop kicks the dead horse a few more times. It’s therefore also worth quoting Bishop’s key points about the Dore treatment:

1 The treatment offered by Dore Achievement Centres is being promoted as a “drug free” alternative to conventional treatment for ADHD, and as a ‘miracle cure’ for dyslexia. It is presented as having a neurological rationale and gains credibility by appearing to be medical treatment.
2 The publication of two papers in peer-reviewed scientific journal (Dyslexia) has been presented as giving further credibility to the treatment. However, the research community in this area has been dismayed that work of such poor standard has been published.
3 The research purporting to show efficacy of the treatment does not show sustained gains in literacy scores in treated vs. control children. Furthermore, the intervention has not been evaluated on the clinical groups for which it is recommended.

Ouch. If only more articles in science journals were like this – clear, well-written, and brutal in a rather entertaining way – they’d make much better weekend reading…

More Evidence for the Safety of Vaccines

29 Sep

This article was originally published at the NeuroLogica Blog and is re-published here with permission.

By Steven Novella, MD
NeuroLogica Blog

A new study just published in the New England Journal of Medicine, Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years, does not support a correlation between mercury in vaccines and neurological damage. It adds to the growing evidence that vaccines are safe and they do not cause neurological disorders. This study did not look at autism (a study that will be published next year looks, again, at vaccines and autism), but the mercury-causes-autism crowd are still unhappy with the results.

I have been following this issue closely for several years. Although my awareness of the issue goes back much farther, I started to seriously research the claim that the MMR vaccine, or that thimerosal in other vaccines, causes autism while researching an article on the topic for the New Haven Advocate. As a physician (a neurologist) and a skeptical activist I knew I had to get this issue right. I certainly did not want to falsely stoke the flames of public fear, nor did I want to cast myself in the role of denier.

Early on in my research I really did not know which way I was going to go with the issue. Should my bottom line be that there is real reason for concern here, that there is nothing to the claims, or that we really don’t know and will have to just wait for further research? But after reading through all the claims on both sides, and all the research, it was an easy call – vaccines, and specifically the MMR vaccine and thimerosal, do not cause autism, and the alleged autism “epidemic” is likely just an artifact. Those claiming there is a connection were drowning in conspiracy thinking, logical fallacies, and blatant pseudoscience. Meanwhile every piece of reliable clinical data was pointing in the same direction – no connection.

But still, while I was confident in my final conclusion, a small connection between mercury and autism that eluded the existing data could not be ruled out. Or perhaps there was an angle to the whole story that we were missing but would later come to light. I have had enough experience with scientific medicine to be humble in the face of the complexity of medicine and biology. The only rational position is to remain open to new data and new ideas. On this issue there was sure to be more studies in the future – and the ultimate test of the thimerosal-autism connection, the removal of thimerosal from the vaccine schedule, was yet to be seen. So I confidently plunked my nickel down and waited for the future to unfold.

Everyone likes being right, and sometimes this desire clouds our judgment. I have learned, therefore, how to cheat, which is to say how to always be right. All you have to do is say that your position is based upon the existing data, but is contingent upon the results of future studies. In other words, the “right” position is to change your final answer to accommodate new evidence as it comes in. Therefore the only “wrong” answer is to stick to your original position despite new evidence that contradicts it.

OK – so this is just restating how science is supposed to work, but it is amazing how many people forget to cover their behinds with this simple rule. Usually this is because they are not doing science – they are taking an ideological position, and ideology is inflexible. This is a huge advantage for science over ideology, and why, when science and ideology clash, science is almost always right.

In the case of vaccines and autism, since writing my first major article on the topic, the data has come in all consistent with my original position (so I get to be doubly right). Removing thimerosal from vaccines did not decrease the incidence of autism (or decrease the rate of increase in new diagnoses). And several new major studies came out all showing no association – not counting the utter crap being produced by the Geiers.

Enough had happened to warrant an update, so I jumped at the chance when Ken Frazier of the Skeptical Inquirer asked me to write an article on the topic. My article will be out in the next issue, along with a couple of smaller ones on the same topic, so take a look.

Alas, as is often the way in the world of science, my paper is outdated before it even goes to print. This new study, of course, will not be covered in the article. But that’s what blogs are for – instantaneous news and analysis.

Actually, several of my fellow science bloggers have already beat me to the punch. They cover the article, and the response to the article by the mercury crowd, in great detail, so I will not duplicate it here.

Orac at Respectful Insolence goes over the press release of A-CHAMP (one of the mercury militia) that attempts to dismiss the study. He shows that, while the study (like all studies) has its weaknesses, it does add significantly to the body of evidence showing that vaccines are safe. The complaints of A-CHAMP are either wrong, overblown, or inconsistent with their prior positions and shows that they are just trying to tear down the study at all costs.

For the record, I agree with Orac that the study is good enough that it’s conclusions add to the cumulative data on this topic, and that the weakest element of the study was the 30% compliance rate. In other words, only 30% of the subjects that they looked at for the study made it into the final analysis. This opens up the door for selection bias. Orac is probably correct that this bias would likely overestimate a correlation, not underestimate it, but you can never be sure with such things.

I will add that the 30% figure is not as bad as it first seems. The study reports:

Of 3648 children selected for recruitment, 1107 (30.3%) were tested. Among children who were not tested, 512 did not meet one or more of the eligibility criteria, 1026 could not be located, and 44 had scheduling difficulties; in addition, the mothers of 959 children declined to participate. Most of the mothers (68%) who declined to participate in the study and provided reasons for nonparticipation cited a lack of time; 13% reported distrust of or ambivalence toward research. Of the 1107 children who were tested, 60 were excluded from the final analysis for the following reasons: missing vaccination records, 1 child; missing prenatal records, 5; missing data regarding weight, 7; and discovery of an exclusionary medical condition during record abstraction, 47. Thus, 1047 children were included in the final analyses. The exposure distribution of the final sample was similar to the exposure distribution of the initial 3648 children selected for recruitment in the study.

So about 40% of those that did not make it into the final analysis simply could not be located – this is unlikely to represent a bias. But this is a small point.

Isles from Left Brain/Right Brain points out that Sallie Bernard (a believer in the mercury hypothesis) was consulted on the study design and execution and did not criticize its methods until after the results came back negative. That kind of behavior instantly sacrifices all your credibility in the science club.

Kristina Chew at AutismVox reiterates what I did above – that the mercury-causes-autism ideologues are always asking for more studies, but refuse to change their position when the studies they ask for come out. They are waiting for studies that show what they want them to show – we call that “cherry picking.”

The other side is busy too. David Kirby (a bad journalist who desperately wants to be a bad scientist), who wrote the book Evidence of Harm, published an article online in that absolute rag, The Huffington Post (to be fair, they also published this piece by Arthur Allen defending the paper’s conclusions). Kirby repeats all the same points in the A-CHAMP press release, but he emphasizes the fact that the study found some neurological symptoms that were higher in the subjects who received more thimerosal. Kirby proceeds to completely misinterpret the significance of this.

The study looked at 42 different outcomes, and set the p-value for significance at 0.05. A vague concept of basic math should be sufficient to see that some outcomes will reach significance by chance alone. The researchers arguably should have adjusted their statistics to account for the fact that they were looking at 42 variables – but instead they just looked at all the outcomes that were significant to see if there were any patterns or trends. What they found was that there were a few scores that were worse among those exposed to more thimerosal, but there were also a few scores that were better. There was a random distribution of positive and negative effects that essentially average out to no net effect. It’s all just noise. (Is there a small signal hiding in the noise? There could be – scientists have to be honest about that. But that doesn’t mean there is.)

What Kirby does is not just really dumb, it’s despicable. He cherry picks all the negative (meaning bad) neurological outcomes and pretends that the study shows a correlation (it doesn’t, when you look at ALL the data). He then tries to dismiss the positive (good) outcomes as absurd. He mockingly writes:

If they (the CDC) really mean that thimerosal increases IQ levels in males, then sign me up for a double-dose flu shot this year.

No, David, they don’t mean that. Not by any stretch of the imagination. It takes incompetent statistical analysis or the blindness of ideology to write something so ridiculous. What the CDC means is that the study does NOT show that thimerosal increases IQ, nor that it causes motor tics, or improve motor skills, or decrease language skills, or anything else. The study showed no correlations because it all averaged out as noise.

This is, by the way, the same mistake that astrologers make (remember that crusty pseudoscience?). They look at many variables then cherry pick the outliers. At best what this study might show is a possible correlation, but any such possible correlation would have to be corroborated by a later study (with fresh data) that looked specifically at that one variable.

So the pattern that I found when I first started looking at this issue – that all the reliable data was on the side of no correlation between vaccines or mercury and autism or neurological disorders – continues to hold up to new data. The other pattern I noticed – that those promoting a correlation were relying on bad science, logical fallacies, and ad hoc conspiracy claims – also continues to hold.

In the last few years every new study showed no correlation, and the mercury militia responded with abject nonsense and dismissal. This cycle seems to be repeating itself over and over, and this latest study is no exception.

Bloodletting 101 – an alternative history

29 Sep

Alt-med groupies tell us they are on the cutting edge of medical science, and that fringe providers are somehow protecting patients from the ravages of evidenced-based medicine. They even offer examples, as one austim list serve member did when he wrote “Mainstream medicine used to think bloodletting cured disease. So science doesn’t have all the answers!” I’ve read variations on this statement.

It’s true that doctors once prescribed bloodletting for a wide range of conditions. The ancient Greeks were big into bloodletting, based on a non-empirical view of the natural world which held that blood was composed of four “humours”, symbolizing earth, air, water and fire. Bloodletting was popular for 2,000 years because it seemed to work. Some patients improved after being bled. Doctors just knew it worked, and could point to centuries of precedent.

It’s difficult for the modern mind to grasp why anyone would consider deliberate bloodletting to be a cure for anything. But the answers are quite simple.

First of all, patients have always felt that it’s better to do something than nothing. Before the germ theory of disease, which is only 130 years old, there wasn’t much doctors could do for most diseases short of bed rest and chicken soup. Bloodletting may have been messy and painful, but at least someone was trying something. So, odd as it may seem, bloodletting actually had a placebo effect on some patients.

Since bloodletting wasn’t evidenced-based, it was assumed that those patients that improved after being bled must have benefited by the bleeding. If anybody had thought to do a controlled study 500 years ago, they would have found that the patients who weren’t bled recovered more quickly and in greater numbers than the ones that were. But alas, evidence-based medicine was still a ways off.

I suppose if there was an internet back then, one could have learned the benefits of bloodletting from scores of websites. Bleed Autism Now! practitioners would spread the BAN! protocol far and wide, telling story after story of the children who were rescued from the abyss of mind-blindness and senseless spinning. The more people who signed on to the BAN! protocol, the more self-evident its worth. Heart-shaped Autism Bandages would adorn every donkey cart, testament to the love that parents felt for the children they bled.

And evidence-based skeptics would have been called “hemophobes” and burned at the stake as child abusers.

History teaches: Quackery – hard to kill. People – not so much.

29 Sep

New Scientist had an article recently describing the history of the use of X-rays as a beauty treatment. Who knew that radiation’s ability to make a person’s hair fall out was once exploited as a hair remover?
Histories: The perils of X-ray hair removal

FOLLOWING Wilhelm Roentgen’s discovery of X-rays in 1895, doctors around the world turned their primitive X-ray machines on everything from their own hands to patients with cancer and tuberculosis. To Albert Geyser, a brash German immigrant who graduated from a New York medical school in that heady year of discovery, X-rays were clearly the future of medicine.

Researchers quickly noticed that exposure to X-rays had a remarkable side effect: it made hair fall out. In Austria, physician Leopold Freund recommended it as a treatment for excess body hair, or hypertrichosis. “Hair begins to fall out in thick tufts when lightly grasped, or it is seen on the towel after the patient’s toilet,” he observed in 1899. … Tests followed across Europe and North America with apparent success, … There were already hints that all was not well, however. In France, some doctors reported that their patients had fallen ill. Loath to admit that X-rays were responsible, Freund blamed “the hysterical character” of French patients.

Now working at Cornell Medical College in New York, Geyser embraced X-rays with enthusiasm. Like many others, he paid a high price for his zeal: radiologists were belatedly realising that frequent exposure to X-rays could be dangerous, and Geyser suffered burns that claimed the fingers of his left hand. Undeterred, he invented the Cornell tube – an X-ray vacuum tube of leaded glass with a small aperture of common glass, meant to direct lower-energy, or “ultrasoft”, X-rays directly onto a small area of skin. With the Cornell tube, “the X-ray is robbed of its terrors”, declared The New York Times. By 1908 Geyser had administered about 5000 X-ray exposures with his tube, for a variety of skin ailments. Others remained suspicious of X-rays, and the County Medical Society’s lawyer warned Geyser that “the time is coming soon when if a man is burned, the doctor will be held liable… Don’t use the X-ray unless you know what you are doing with it.”

The article goes on to explain how the use of the Cornell tube’s “ultrasoft” hair-removing rays became known as the “Roentgen therapy for hypertrichosis,.” In 1915, Geyser published an article in, The Journal for Cutaneous Diseases, he assured his readers that “no protection of any kind, either for patient or operator” was needed when using his Cornell tube. In 1924, Dr. Geyser and his son founded Tricho Sales Corporation. They advertised the glories of the Tricho System in hundreds of advertisements that went into newspapers throughout North America. Promises in these ads included: “no injury to skin will result.” Explanations of how it worked noted that it used a “hair starvation process” and that it worked by way of, “radio vibration.” Female relatives of physicians just swore by it, apparently.

Soon there were Tricho clinics in over 75 cities in the U.S.. The process was tidy and painless, the only thing that operators or clients might have noticed was a “faint hum and a whiff of ozone.” The women only need to be exposed to the X-rays for a few minutes, and voila, some time later their hair fell out.

You may be asking, “Approximately, how many women underwent this thoroughly modern beauty treatment?” The New Scientist article says the New York City clinic alone claimed 200,000 clients. These clients would have paid from a “few hundred to over a thousand dollars” for a course of treatments. That’s a huge chunk of change in 1920’s dollars.

OK… so are we all waiting for the other shoe to drop here?

Tricho’s triumph was short-lived.

In 1926, Ida Thomas of Brooklyn sued Frank Geyser (the son) for “a staggering $100,739 – the cost of her facial treatments plus $100,000 in damages.” Ms. Thomas sued because her skin had thickened and wrinkled following the treatments. Two years later Frank Geyser “was arrested following a similar complaint.” Then things got really ugly. Clients now were suffering from “wrinkling, mottling, lesions, ulcers and even skin cancer.” The Journal of the American Medical Association commented on this new health problem, “In their endeavor to remove a minor blemish, they have incurred a major injury.” In July 1929, the AMA condemned the treatment as dangerous.

What was Tricho’s tactical response to all these people–like the AMA–bunch of killjoys–trying to bum them out, bring them down? What action could rescue the Tricho Sales Corporation from losing revenue by the handful, not unlike a radiation poisoning victim losing hair?

Well, if you’ve been following the saga of Defeat Autism Now! and similar groups, and their history of promoting questionable and even plainly dangerous quack therapies, you may have at some point thought to yourself:

“What could rescue autism quackery and it’s adherents from the doldrums induced in part by the death of Abubakar, but also by the criminal charges being brought against the DAN! doctor who killed him, the lack of a promised drop in the numbers of children being diagnosed with autism following the reduction of the use of thimerosal in childhood vaccines, the ridiculous show put on by so-called “expert witnesses” chosen by the Petitioners Steering Committee in the Cedillo vaccine hearing, accumulating evidence tending to exonorate vaccines as not being a cause of autism, and even the exposing of Andrew Wakefield’s seeming ethical problems in his General Medical Counsel hearing in London?”

Or, “What does autism wingnuttery need, right now, to give it life again, you know, fluffliness and bounce and shine, like a good salon-quality shampoo can do for listless hair?” Maybe autism quackery could borrow a page from the Tricho corporation playbook…what DAN! and company needs NOW is and what Tricho Sales Corporation got in their hour of need …

A celebrity endorsement!

Ann Pennington

Ann Pennington, was played as Tricho’s “trump card,” according to the NS article. She was the star of 1929’s hit film, Gold Diggers of Broadway.” The article continues:

And if clients had any lingering doubts, the elder Geyser’s impeccable medical credentials probably reassured them. Yet closer inspection of Geyser’s record would have shown that although he carried out research at a prestigious medical college, some of his work was decidedly dubious: he had used electric shocks to treat all sorts of conditions, from gonorrhoea to asthma, and had made unsubstantiated claims to have found cures for tuberculosis and anaemia.

Inevitably, more Tricho victims appeared in JAMA, including a patient in Washington DC “so depressed as a result of the disfigurement of the X-ray burn that she attempted suicide”. Geyser, it seemed, had either been too greedy to heed any warnings, or had convinced himself that his Cornell tubes really were safe. Whatever his motivation, he had installed poorly regulated X-ray machines across the country, and tens of thousands of women – perhaps even more – were exposed to massive doses of radiation on their faces and arms. They had also received wildly varying doses: some women had as few as four treatments, others as many as 50. And because X-ray exposure rises as an inverse square of distance, even a slight shift in sitting position could double or treble a client’s dose.

With the prospect of being sued for millions of dollars, the Tricho Sales Corporation collapsed in 1930. …

If we all feel a sort of vicarious relief at this point, turns out, it’s premature. Other companies noticing the financial success of the Tricho clinics developed their own “copycat operations.” If the training was miniscule for the Tricho clinicians, it seems that it was even less among these newcomers to the game. Medical and business groups responded by trying to close down these outfits, too. But they just went underground. The article says that in 1940, San Francisco detectives were on the trail of what they thought was an illegal abortion clinic. To their surprise, no doubt, the place in question was instead one of these hair-removal-by-radiation shops. And such shops were still taking in customers “at least” into the 1950’s.

Since all radiation-poisoning “fallout” isn’t noticeable immediately, you can imagine how the story of the customers of the Tricho clinics kept coming up again and again in doctors offices into the 1960’s and 70’s.

One 80-year-old woman arrived with a grapefruit-sized tumour in her head; another refused treatment until she had “a huge and deep crater occupying practically the whole lower half of the breast and the chest wall immediately below it”. By 1970, US researchers were attributing over one-third of radiation-induced cancers in women to X-ray hair removal.

Given cancer’s long latency and the many years that Tricho parlours and their ilk persisted, the procedure may not yet have claimed its final victim. Tricho’s most famous customer, though, had reason long ago to regret her endorsement. After spending her final years as a recluse in a small hotel room off Broadway, Ann Pennington died in 1971. Her cause of death, it was reported, was a brain tumour.

Now, no one is wishing a grapefruit sized tumor on to Jenny McCarthy or anything. For one thing, in the updated case of quack driven nonsense, the gullible celebrity endorser is not the one who is being subjected to questionable therapies. It’s her son. And no one wishes any harm to come to Jenny’s son in the least. He looks like an adorable boy. It’s a shame his mother has been fooled into believing the whole “most of these kids are practically saturated with candida yeast, it’s the reason they go all stimmy … it makes them act crazy…put them on a prescription antifungal and a restrictive diet and you’ll get your kid back,” thing (not to mention the whole anti-vax and autism epidemic thing). If his mom and doc sent a blood sample off to Immunosciences lab before it was closed (this past July) then she likely got a bogus positive result. Then the fool doctor could write a prescription for a toxic antifungal (all drugs are toxic, don’t you know, depends on the dose) that the kid likely didn’t need–just to make mommy feel like she’s doing all she can to “pull her son through a rapidly closing window” and give her something to write about besides.

One really scary lesson from the Tricho debacle is that this deadly quackery hung around for so long. In this case, bad news, the news that these radiation machines could easily cause a client’s slow death, besides creating some really ugly skin, didn’t seem to travel quickly enough. Tricho shut down in 1930, but the technique and hype they developed was still be employed forty years later on new suckers, the ones born every minute. The Candida yeast (as cause of dozens of chronic disorders) business was a stupid health fad in the 1980’s. The fad died for the most part, but apparently Jenny didn’t know about it, or didn’t take a clue from it, and here she is in 2007 promoting it as the thing that stood between her autistic son and being a typical kid.

It was interesting that the Tricho company was founded by an apparently unethical doctor, Albert Geyser, who had a pretty respectible looking CV, and who claimed to have great insights into and treatments for many different diseases. Albert went into business with his son. Hmmm. Who does that remind one of? Someone else with a German name that sounds a bit like Geyser. There’s also a creepy and creepier brother duo in autism quackery with a similarly questionable looking, but less impressive-looking background.

When one compares the seeming safety profile of Mr. and Dr. Yasko’s (and Garry Gordon’s) ridiculous RNA yeast soup, or the homeopathic water drops said to be favored by Katie Wright, with something like Lupron and IV chelation, one can almost be grateful for such benign, if expensive and reprehensibly misrepresented, “cures.” But there are major question-marks hanging over the safety of things like long-term, high-dose methyl B12 injections given to kids who are not deficient in B12. There are questions about high doses of any vitamins for anyone. Some mineral supplements are contaminated with heavy metals, so are some chelators, apparently. Lots of biomedded kids take vitamin and mineral supplements. There are questions about the dangers of hyperbaric oxygen therapy, like what if the kid is susceptible to seizures and you put him in the HBOT tank and the extra oxygen kindles these seizures?

As for the recent Jenny McCarthy road show and it’s effect on the DAN! dox customer base, it’s hard to say who needed whom more–DAN! suffering from a series of bad PR breaks, or Jenny suffering from a sagging career and a failed attempt at making a go with the Indigomom Crystalkid schtick. It’s hard enough for a talented actress to keep getting work at age 35, they say, imagine what it’s like for short-on-talent Jenny with her now famed post-pregnancy stretch-marks “that glow in the dark … for some reason!”.

DAN! and Jenny McCarthy deserve each other. Let’s hope they both quickly skulk out of the limelight and into obscurity and may they take their quack therapies, benign or not, with them.

Paul Collins is the writer of the above mentioned New Scientist article. The writing style would seem to indicate that it’s the same Paul Collins who is the author of the fantastic book, “Not Even Wrong.” If so, this Mr. Collins is the father of a beloved autistic boy.

CDC: “Thank you, Sallie, May We Have Another?”

27 Sep

A CDC study released yesterday found no evidence to support “a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.” In other words, vaccines don’t scramble your brain.

The study didn’t examine autism as an outcome, although that is almost certainly what it was intended to get at. Instead, it looked for whether children’s exposure to thimerosal before birth or in infancy had any relationship to their later performance on 42 standardized tests which one would expect to be affected by autism. For each of the 1,047 children in the study, the researchers assessed speech and language; verbal memory; achievement (letter and word identification); fine motor coordination; visuospatial ability; attention and executive function; behavior regulation; tics; and general intellectual functioning.

CDC tried so hard. They invited one of the queen mercury moms, Sallie Bernard of “SAFEMINDs,” to participate in the planning of the study. They brought on a panel of outside advisors. The team spent at least two years administering forty-seven separate tests to each of the children and analyzing and writing up the results. They printed every piece of data generated in a companion volume to the published study.

They got kicked in the teeth, but don’t feel bad for them. They should have known better.

The autism-vaccine contingent has responded by spluttering about the study not having been large or random enough, and by accusing the researchers of being biased and of ignoring important associations in the data. It’s no news that these people don’t believe anything that comes from CDC – they’ve said as much, very clearly. But one would think that if you let the antivaxers in on the process from day one, if you were totally transparent, they couldn’t object, could they? They’d have to see the light when the results came back and say, “Well! I guess it’s not the vaccines after all!”

CDC, if you really thought that would happen, you were so, so wrong.

The appearance is that Sallie Bernard was going along with all this up until the day the results came in and – shockingly! – showed thimerosal didn’t do one bit of harm. If she’d thought from the outset, as a SAFEMINDs press release now claims, that there weren’t enough kids in the study or the sampling were biased, does anybody think this gadfly would have nodded and smiled and gone right along with it?

No, everything was fine and dandy as long as she was enjoying being fawned over as a “representative of the autism community” and a fellow-scientist instead of the commercial marketer she actually is. Here’s a clue, Sallie: If you’re going to play scientist, you have to follow the rules of science, and that means you stand by your results. You don’t get to say “heads I win, tails you lose” by waiting to see the outcome before deciding whether the study was any good.

And you really don’t get to have CDC at your beck and call, spend hundreds of thousands of taxpayer dollars to do a study to your specifications, then turn around and call them liars when you don’t like how it comes out.

And you, CDC? You’re not just a victim here. Every time you say “let’s do more research” or “we are examining this issue” in order to appease the mercury moms, you increase the chances that kids will go unvaccinated because you failed to give their parents confidence in the safety of vaccines. When you say a study is reassuring and then highlight what is virtually certain to have been a chance finding (a statistical association between higher thimerosal exposure and transient tics in boys) without making it abundantly clear that some false associations were inevitable given the study design, you defeat the purpose of doing the study. People who understand statistics weren’t the ones who needed to be convinced thimerosal is safe; the antivax crowd will never be convinced no matter what. You needed to speak to the well-meaning parents who worry about the rumors they hear at playgroup, and not only did you give them something new to worry about and whiff the opportunity to show them that the likes of Sallie Bernard are all about the rhetoric – you managed to tee up for yet another round of Righteous Long-Suffering Parents vs. Heartless Government Scientists.

Haven’t you learned yet who wins that one? Or are you going to invite Sallie back for another round of research?

Postscript: More commentary on this study by Arthur Allen, Orac, Joseph, Interverbal, and Kristina Chew.

In 1931…

27 Sep

In 1931 Eli Lilly invented autism.  Or so the story goes.  Again, as the story goes, all autism is mercury poisoning or, more specifically, Thimerosal poisoning.  Thus, Autism didn’t  (and couldn’t) exist before the invention of Thimerosal in 1931.

Dan Olmsted has made a number of bloggish press releases on the “original” autism cases. You know, those kids that Dr. Kanner first reported on. According to that story, somehow all of the first cases (since there weren’t any before then) somehow found their way into Dr. Kanner’s practice.

Wouldn’t it be strange if there were autistic individuals born before 1931? Wouldn’t you expect Mr. Kirby or Mr. Olmsted to let us know if there were evidence of autism that didn’t fit this little model?

In a recent blog post, David Kirby noted that:

“But it turns out that a private citizen has paid the state each quarter to analyze the autism numbers according to year of birth, and not just by age group. State law requires that such privately funded analyses be made available to anyone else who asks for it

So I asked for it. What I got was rather interesting.”

Well, someone else asked for these data sets. Now I have them too.  Joseph has them as well.   And they are rather interesting.

The spreadsheets list the number of clients getting CDDS services by year of birth.  Open the most recent one and there, at the very top, are three of clients born before 1931.  Top of the list, someone born in 1920.   If you look through the past years, you will find as many as five in a single year.  There is evidence for more as some people come and go.

I can already write one of the responses to this post. “Thank you for pointing out that the number is so much less than 1:150 for the older generations”.

While you hope that we all go running after that particular red herring, reread the statement above: “..as people come and go from the system”.  Consider our now 87 year old client mentioned above.  He/she entered the system as autistic in late 1999.

Yessir, at 79 years old this person was added to the CDDS autism roll.   There are a lot of possible reasons.  He/She could have moved into the state, his/her family could have found that they no longer could handle the job alone or, and this is the big question, he/she was already in the system but was only identified as autistic at this late age.

That’s not the only example.  In 1992, a 70 year old was added to the list under autistism.  In 1992 a 64 year old was added, followed by another in early 1993. 

There are more, but you get the point.  These people, people born before the invention of Thimerosal are autistic and are being added to the CDDS lists as autistic late in life.

I do wonder why Mr. Kirby didn’t mention this.  I do wonder why he didn’t shoot a quick email to Mr. Olmsted to point this out.  One has to think that Dan Olmsted would be interested in getting the stories of the pre-Thimerosal, pre-Kanner autistics.  Then again, one has to imagine that Dan Olmsted probably has seen these data for himself already.  Why neither of them has seen fit to mention this or dig deeper into this is an open question.

For once I agree with David Kirby, “What I got was rather interesting”.

Delay Not Halt

26 Sep

A new study from Washington University in St. Louis has confirmed what a lot of us suspected about the developmental nature of autism: that it gets ‘better’ with time. A quick quote:

Like most people, individuals with developmental disabilities such as autism continue to grow and change over time, Shattuck explains: “Their development is not frozen in time and forever the same. That’s just not the case.”

So, contrary to the oft-espoused crapola from the anti-vaccine/autism groups (TACA, Generation rescue, SafeMinds, NAA, Treating Autism) that our kids will be stuck in this non-developing situation forever, actual _science_ – when it looked at the question – found that the direct opposite was true; that autistic people develop as they get older.

You won’t be surprised to hear me say that, for me, this casts extreme and renewed doubt on the claim by the chelation/lupron/HBOT extremists and child-experimentalists that without the miracle cure du jour their poor, poor child would have just rotted away. In fact, next time someone claims to you that without treatment X their child would not have progressed, please point them to this study.

For all major symptoms, the percentage of people who improved was always greater than the percentage who worsened,” Shattuck says. “If there was significant symptom change over time, it was always in the direction of improvement, though there was always a group in the middle that showed no change. The mean never went down.

Lets be absolutely clear about this study though – it does not claim that (as you can see from the above quote) – that every autistic person changes. It would be strange if it did. In all walks of life there will be a group who do not. But it is clear from the presented results that improvement over time is a regular and common feature of autistic development.

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