Archive | Vaccines RSS feed for this section

Andrew Wakefield’s many statements that MMR causes autism

8 May

One of the themes that has grown in the past couple of years that Andrew Wakefield never said MMR causes autism. Rather, the story goes, he was a cautious researcher who merely reported what parents told him and called for more research to be done.

Here is an example by Mr. Dan Olmsted of the Age of Autism blog:

That Early Report – which appeared in 1998 in the Lancet, Britain’s other leading medical journal – noted that in eight of the 12 children (including Thomas’s), parents linked the onset of symptoms to the MMR shot, and it called for more research to see if a link in fact existed. It said no link to the MMR was established by the simple case series report.

Despite that cautious approach, the report and its aftermath sparked a firestorm that, fueled by Deer, ultimately led to Wakefield losing his medical license and to the Lancet retracting the report. Yet thousands of parents continue to support Wakefield and describe the same sequence of shot and symptoms as parents in the original case series. Mainstream media, medical groups, public health officials and pharmaceutical companies say any link has been discredited.

For those who have actually followed the Wakefield/MMR story, the idea that Mr. Wakefield’s approach could be described as “cautious” is difficult to swallow. The idea that the “firestorm” was fueled by Mr. Deer is an odd assertion at the best. Mr. Wakefield’s now-retracted Lancet paper was published coincident with an anything-but-cautious press conference in February 1998. Mr. Deer started reporting in the story in February of 2004. But this is off topic. Mr. Wakefield is repeatedly cited as merely calling “for more research to see if a link existed”.

Mr. Olmsted is not the only one to use the “only called for more research” theme. Dr. Bob Sears, for example, stated:

1. Dr. Wakefield’s study never claimed there was a link between the MMR and autism – it only suggested a possible correlation between the MMR vaccine triggering intestinal inflammation which seems to occur in some children with autism. He basically called for MORE research to be done on this.

To be fair, the “only called for more research” theme goes back quite a way. Here is a news story from 2003.

The problem for Mr. Wakefield’s supporters is that Mr. Wakefield did not limit his discussion to the Lancet. As already noted, he held a press conference to announce his results and has made many more statements over the years. More to the point, Mr. Wakefield *did* say that the MMR causes autism.

Here is a collection of Mr. Wakefield’s statements which range from suggesting a possibility that the MMR causes autism to outright claiming that he “has shown” that the use of the MMR vaccine causes autism.

Mr. Wakefield’s patent application states clearly and unequivocally that the MMR vaccines has “been shown” to cause “pervasive developmental disorder”:

“It has now also been shown that use of the MMR vaccine (which is taken to include live attentuated measles vaccine virus, measles virus, mumps vaccine virus and rubella vaccine virus, and wild strains of the aforementioned viruses) results in ileal lymphoid nodular hyperplasia, chronic colitis and pervasive developmental disorder including autism (RBD), in some infants.”

And also

I have also found that regressive behavioral disorder (RBD) in children is associated with measles, mumps and rubella vaccination.

More examples include:

In the 1998 Lancet paper (now retracted), the MMR is referred to as one of the “the apparent precipitating events”

In sworn testimony in a congressional hearing Mr. Wakefield states that an “environmental insult” (previously discussed at length as vaccination) “in many children, clearly, the subset of autistics, it leads to gut infection and damage…”

So finally, in summary, we have an environmental insult in perhaps a genetically susceptible child. The problem is that if you go to Sweden now, autism affects over 1.2 percent of the pediatric population. So if there is a genetic background, it is clearly widely distributed within the population. We believe that in many children, clearly, the subset of autistics, it leads to gut infection and damage; that leads to an ingress, an impaired metabolism, degradation of these chemicals from the gut which then get through and impact upon the brain.

In the video for the press conference for his (now retracted) 1998 Lancet paper, Mr. Wakefield stated that the single (monovalent) vaccines are “safer than the polyvalent”. How can they be safer if there isn’t a proven link to autism?

My opinion, again, is that the monovalent, the single vaccines, measles, mumps and rubella, are likely in this context to be safer than the polyvalent vaccine.

and his feeling is that “the risk of this particular syndrome developing is related to the combined vaccine…”:

Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.

From the Power of One Idea” rally, Washington DC, April 21, 2002. Mr. Wakefield informs the public that public health officials have failed and “Among the reasons for this failure is the fact that they are faced with the prospect that they themselves may be responsible for the epidemic”:

We are in the midst of an international epidemic. Those responsible for investigating and dealing with this epidemic have failed. Among the reasons for this failure is the fact that they are faced with the prospect that they themselves may be responsible for the epidemic.

Therefore, in their efforts to exonerate themselves they are an impediment to progress. I believe that public health officials know there is a problem; they are, however, willing to deny the problem and accept the loss of an unknown number of children on the basis that the success of public health policy – mandatory vaccination – by necessity involves sacrifice.

Neither I, nor my colleagues subscribe to the belief that any child is expendable. History has encountered and dealt with such beliefs.

You, the parent’s and children, are the source of the inspiration and strength for our endeavours; our quest for truth through science – a science that is compassionate, uncompromising and uncompromised.

I do not mean to stir you to mutiny, but be assured that armed with this science it is in your power to force this issue, in your pediatricians office, in Congress, in the Law Courts.

Keep faith with your instincts. They have served you well.

From a news story (Shame on officials who say MMR is safe) in 2001, Mr. Wakefield is quoted discussing how there are “long-term adverse reactions that I believe we are now seeing”.

Our new paper is not anti-vaccine. It is about the safest way in which to deliver these vaccines to children in order to protect them against acute infectious disease and against the long-term adverse reactions that I believe we are now seeing

From a BBC news program in 2002. The regression following MMR is referred to as “not a coincidence”:

WAKEFIELD: .. these children received not one dose but three doses of the MMR vaccine, and what we see in many of these children is a double hit phenomenon. They regress after the first dose and then they regress further after the second dose. This child did not receive his first MMR vaccine until he was 4 years 3 months of age. He then deteriorated into autism, a disintegrative disorder. He then received his second dose at 9 years of age and disintegrated catastrophically. He became incontinent of faeces and urine and he lost all his residual skills. This is not coincidence.

This is not to be considered an exhaustive list. I won’t be surprised if more quotes from Mr. Wakefield are in the media. But these should suffice: Mr. Wakefield has, repeatedly, stated that MMR causes autism.

Todd W., running for a good cause

26 Apr

Todd W. of Harpocrates Speaks is a frequent author of articles and commenter in online discussions involving questions of vaccines and vaccines and autism.

In his article, Help Me, Interwebz! You’re My Only Hope!, he tells us that he is participating in a run to raise money for medical research. In specific, he’s helping to raise money for a new type of vaccine adjuvant:

The VIC is researching the use of a laser as a vaccine adjuvant. Basically, adjuvants allow vaccines to use fewer antigens by increasing the body’s immune response. In the U.S., we use aluminum salts (e.g., aluminum hydroxide, aluminum phosphate, and aluminum potassium sulfate) as adjuvants. Because there are some individuals who question the safety of these adjuvants (largely based on false information), the laser adjuvant may induce a similar boosted immune response without the concerns associated with aluminum. It also has the potential to reduce even the current minor side effects associated with aluminum adjuvants, like local soreness and swelling. The VIC researchers have completed animal studies and are ready to move on to human trials. Although the initial research focuses on influenza and hepatitis B vaccines, there is potential for this technology to be applied to a much wider range of vaccines. In the end, this could hopefully make for more effective and safer vaccines, as well as improve overall immunization rates among those worried about ingredients like aluminum.

Todd W. has details on how to contribute in his article, but if you want the short version:

You can be a part of this innovative research by supporting my flight through the zombie-infested wilderness of Amesbury by going to this page and making a donation. If you would rather make a gift by mail, make your check payable to:

Massachusetts General Hospital
Development Office
165 Cambridge Street, Suite 600
Boston, MA 02114

Make sure to put “Todd’s Zombie Run” in the memo line or in a note with your donation. All gifts will go to support these two projects and are 100% tax deductible.

Congressman Dan Burton: It is time to re-engage on the autism epidemic

25 Apr

Dan Burton is a U.S. Congressman, a legislator elected to represent the state of Indiana to the U.S. House of Representatives. Mr. Burton was once a frequent name in the discussion about autism. His grandson is autistic and Mr. Burton championed the idea that mercury, in specific the vaccine preservative thimerosal, was a possible cause of autism. Mr. Burton hosted congressional hearings on the matter which fueled the discussion. Much of this is documented in David Kirby’s 2005 book Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy.

When Congressman Burton was holding meetings In the early 2000’s, there was not a great deal of scientific data on the idea that mercury could be behind an autism epidemic. There was correlation–autism prevalence estimates by various sources showed rising rates coincident with the increased exposure from infant vaccines during the 1990’s.

But this isn’t the early 2000’s. A lot has been learned since Mr. Burton held his hearings. And the knowledge gained points away from thimerosal as a cause if autism Mr. Burton himself is set to retire this year. Yesterday Mr. Burton wrote about his previous efforts and a new initiative he has proposed in a blog article: It is time to re-engage on the autism epidemic. And by epidemic, Mr. Burton appears to mean the failed mercury-induced-autism-epidemic. From his article:

Unfortunately, a great deal of misinformation has been thrown around in public and private about the Committee’s focus on mercury in medicines as a possible factor in the autism epidemic. I’m not a scientist, but the Committee heard from many credible scientists and experts who are convinced that mercury is a contributing factor; and the theory is no less worthy of exploration than the theories being propounded today that the pregnancy weight of the mother or the age of the father at conception influences whether a child becomes autistic. When you have no idea what is causing a disease, policymakers and scientists should never be afraid to investigate any plausible theory. In fact, researching possible environmental factors is a central component of today’s research on autism.

Mr. Burton’s attempt to compare the mercury hypothesis to recent results falls flat. For one thing, there is evidence that factors such as parental age may increase the risk of autism. Multiple studies indicate increased risk. On the other side, there is no real evidence to suggest that mercury increases the risk of autism, and a great deal of evidence to the contrary.

As already noted: a lot has been learned since Mr. Burton held his hearings 10 years ago. But today, as it was 10 years ago, scientists and policymakers are not afraid to investigate the hypothesis that mercury caused an autism epidemic. We’ve seen paper after paper come out of those efforts. Accepting results is not fear. Far from it.

Mr. Burton states:

The other issue we dealt with is how do we help the millions of individuals and families afflicted with this disease. Autism has no cure and it is not a life-threatening disease. That means that the autistic children of today will be the autistic adults and autistic seniors of tomorrow. Our nation is ill prepared to deal with the complex challenges posed by a generation of autistic individuals.

It strikes this reader that the leadership of the past, which certainly includes Congressman Burton, was afraid to tackle a basic question: what is an accurate count of the number of autistic adults? The autistic children of yesterday *are* the autistic adults of today. How many are there? What do their living conditions look like? What successes and failures can we learn from the lives of those autistics, and the way the rest of society supported them? What health issues are there for autistics as they age?

The sad fact is we don’t really know.

Some researchers in the U.S. have looked for, and found, misdiagnosed autistics in some populations. The U.S. has mounted a project to explore autism prevalence and other issues in older cohorts, but that work has just begun. Researchers in the U.K. have delved into the questions of adult prevalence and living conditions, five years ago.

The U.S. is ill prepared, and precisely because of the leadership Mr. Burton offered. Instead of accepting even the possibility that there were misdiagnosed or undiagnosed adult autistics, attention was focused on asking the same question again and again: is mercury behind the rise in autism prevalence? Time and again the answer came back no.

And, now, we are going to ask yet again. Mr. Burton mentions in his article a bill he sponsored: H.R. 3489: White House Conference on Autism Act of 2011. Yes, a bill from last year. It was introduced to committee on Nov. 18th of last year and has had no action since. In other words, a bill which is all but dead.

The bill calls for a conference. A meeting. To generate a report. The conference has no charge other than this. It is reminiscent of Mr. Burton’s hearings. People gathered. People were selected specifically to speak based on their views that mercury could cause autism. Reports were generated. This is action? Leadership?

Who will be a part of this conference? Mr. Burton’s bill spells out who should be a part of this committee:

(1) at least 1 shall be a parent or legal guardian of individuals with autism or other pervasive developmental disorders;

(2) at least 1 other shall be knowledgeable about autism intervention programs and systems, including complementary and alternative therapies;

(3) at least 1 other shall be knowledgeable about programs specifically designed to meet the unique educational needs of children and adults with autism;

(4) at least 1 other shall be knowledgeable about programs specifically designed to meet the unique housing needs of children and adults with autism;

(5) at least 1 other shall be knowledgeable about programs specifically designed to train and educate law enforcement and criminal justice officials to respond to the unique needs of children and adults with autism; and

(6) at least 1 other shall be knowledgeable about environmental or toxic exposure of adults and children as it relates to the development of autism.

A lot has changed since Mr. Burton held his first hearings on autism. One thing that has changed: autistics have rightfully fought for and won the right to be represented in autism discussions. Mr. Burton’s bill does not represent that shift.

Mr. Burton’s words do not acknowledge that the question of whether there was a mercury-induced-epidemic of autism has been answered.

Let’s put it simply. Mr. Burton: the answer is no. Thimerosal didn’t cause an autism epidemic.

The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia.

24 Apr

A paper from researchers in Japan studies the questions of whether vaccines cause autism. In this study, The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia, the authors use a case-control method. The study is moderate in size, 189 autistics and 224 controls.

OBJECTIVE: The aim of this study was to investigate the relationship between autism spectrum disorder (ASD) and general vaccinations, including measles-mumps-rubella (MMR) vaccine, in Japanese subjects, a population with high genetic homogeneity.

PATIENTS AND METHODS: A case-control study was performed. Cases (n=189) were diagnosed with ASD, while controls (n=224) were volunteers from general schools, matched by sex and birth year to cases. Vaccination history and prenatal, perinatal, and neonatal factors from the Maternal and Child Health handbook, which was part of each subject’s file, were examined. To determine the relationship between potential risk factors and ASD, crude odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated, and the differences in mean values of the quantitative variables between cases and controls were analyzed using an unpaired t-test. Moreover, MMR vaccination and the effect of the number of vaccine injections were investigated using a conditional multiple regression model.

RESULTS: For MMR vaccination, the OR was 1.04 (95% CI, 0.65-1.68), and no significant differences were found for the other vaccines. For all of the prenatal, perinatal and neonatal factors, there were no significant differences between cases and controls. Furthermore, regarding the presence of ASD, MMR vaccination and the number of vaccine injections had ORs of 1.10 (95% CI, 0.64-1.90) and 1.10 (95% CI, 0.95-1.26), respectively, in the conditional multiple regression model; no significant differences were found.

CONCLUSIONS: In this study, there were not any convincing evidences that MMR vaccination and increasing the number of vaccine injections were associated with an increased risk of ASD in a genetically homogeneous population. Therefore, these findings indicate that there is no basis for avoiding vaccination out of concern for ASD.

The authors confirm multiple previous studies that the MMR vaccine does not increase the reisk of autism. They also present results that the number of vaccine injections also does not increase the risk of autism.

The authors also find that the number of injections is does not increase the risk of autism.

The MMR vaccine was used in Japan from 1984 to 1993, and the study includes children born from April 1984 to April 1992. Controls were selected according to these criteria:

One to two controls were selected for each case, matched by sex and year of birth and recruited as volunteers from general schools in the Kanto area, the same area where YPDC patients reside. Consent for participation in the present study was obtained from the parents (or legal guardians) of the students. Students who had previously been recognized as having developmental problems and were already receiving care were excluded, as were those whose records in the MCH handbook were missing or illegible and those with a history of vaccination in another country.

The team had a pool of 354 autistics to work from in this geographic region and time period. They were unable to obtain controls for all of these 354, so 189 autistics were randomly selected as cases.

Among the patients who initially consulted the clinic between April 1997 and March 2011, 1875 cases of ASD were identified. Of these, 89 cases were excluded because the MCH handbook was missing or the vaccination record in the handbook could not be read, and 3 were excluded because they had received MMR vaccination overseas. Of the remaining 1783 cases, 1429 were born before March 1984 or after May 1992, leaving 354 cases (males: n = 286, 80.8%) born between April 1984 and April 1992, the possible time period for MMR vaccination. The ASD group consisted of 280 subjects with Autistic disorder (79.1%), 27 subjects with Asperger disorder (7.6%), and 47 subjects with Pervasive developmental disorder not otherwise specified (13.3%).

MMR was not universally given in Japan during this time, and here are the vaccination rates for the cases and controls:

The vaccination rates in cases and controls were as follows: MMR, 24.9% of cases and 24.1% of controls; Measles, 66.7% and 62.9%; Mumps, 58.2% and 49.1%; Rubella, 57.1% and 53.6%; DPT, 97.9% and 97.8%; Polio, 97.4% and 98.7%; B-encephalitis, 88.4% and 92.0%, and BCG 96.3% and 97.3% (Table 1). The mean times of each vaccine injection in cases and controls were as follows: DPT, 3.8 times of cases and 3.7 times of controls; Polio, 1.9 times and 2.0 times; B-encephalitis, 1.7 times and 1.8 times (Table 2).

The authors note that this is the fourth case-control study on autism and the MMR, but that those studies relied upon more genetically heterogeneous populations:

The three previous case–control studies focused on the relationship between ASD and MMR. Specifically, the investigation of DeStefano et al. was based on the Metropolitan Atlanta Developmental Disabilities Surveillance Program [31]; Smeeth et al. used data from the UK General Practice Research Database [32]; and DeWilde et al. examined the association using the UK Doctors’ Independent Network Database [33].

As a side result, the authors tested whether maternal hypertension was associated with autism. They found an odds ratio of 2.4, but that this result was not statistically significant. This is in contrast to a recent study from the U.C. Davis MIND Institute.

Here is table 1 from the study, giving the odds ratios for MMR and other vaccines (click to enlarge):

Criticisms will include: the moderate size of the group, the selection criteria, the fact that the controls were volunteers and might therefore have some selection bias, the fact that not enough controls were recruited to include all the autistics, and the fact that most children who did not get the MMR received the measles, mumps and/or rubella vaccines as individual vaccines, the fact that vaccine uptake is high in Japan, the lack of a “vaccinated vs. unvaccinated” structure to the study and more.

Taken alone, yes, this would not be convincing evidence that the MMR vaccine doesn’t increase the risk of autism. This doesn’t mean this isn’t a good study. Further, it is well worth noting that this study does *not*stand alone. Multiple studies have shown that the MMR does not increase the risk of autism.

Also worth noting is that by looking at the total number of injections, this study in essence considers the question of whether “too many too soon” is a cause of autism. Based on these results, within the limitations of the study, the answer is no.

The Geier story on testosterone shifts again

19 Apr

When Mark and David Geier first proposed using Lupron on autistic children, it was supposedly to help remove mercury from the brain. Their theory was that mercury and testosterone bound together in the brain and that this prevented chelators from being able to remove the mercury. They first approached the Rev. Lisa Sykes, whose son was one of their patients, with the idea. You can hear her discuss that encounter here.

The blurb for that video was:

The Reverend Lisa Sykes is the mother of a recovering autistic boy (Wesley) and an ordained minister, currently serving as Pastor for the Christ United Methodist Church in Richmond, Virginia. In this interview, Rev. Sykes discusses how she came to having her son treated using the Geiers’ “lupron” protocol to more effectively remove heavy metals by first lowering Wesley’s abnormally high testosterone levels.

In the video, Rev. Sykes quotes David Geier (Mark Geier’s non-doctor son and partner in his clinic and research) in the video as saying:

“Do you know, we’ve figured something out!”

“We think we can get rid of the mercury by lowering the testosterone”

As the Geiers and the Rev. Sykes have been major proponents of the failed mercury causation idea, this is not surprising.

The science behind the idea was bad. To the point of laughable, if it weren’t for the danger posed to disabled children.

Mr. Geier has since had his license to practice medicine suspended, in large part due his “Lupron protocol” and the way he misdiagnosed children with “precocious puberty” in order to prescribe Lupron.

The Geiers and Rev. Sykes have a new paper out: “An evaluation of the role and treatment of elevated male hormones in autism spectrum disorders.”

The word “mercury” doesn’t appear in the main body of the paper at all. Just in a citation to one of the Geier team early papers. But they do conclude:

Anti-androgen therapy should be considered as an effective means to significantly help improve clinical features of patients diagnosed with an ASD.

The paper was published in Acta Neurobiol Exp, a journal by the Neuroscience Society. The journal has an editor who is a proponent of the idea that vaccines cause autism and has a history of publishing low quality papers promoting the idea.

Frankly, I see this as an attempt by the Geiers to create a defense for their previous actions, those which resulted in Mark Geier’s license suspension. By distancing themselves from both the purported chelation idea and the precocious puberty idea they can create a justification for why they treated disabled children with a drug for which there was no clinically indicated need.

Suspension of Mark Geier is upheld

19 Apr

Mark Geier is a name well known in the autism world of alternative medicine as well as a major source of papers purporting to link autism to mercury. He had a medical practice, was licensed in multple states, presented repeatedly at autism parent alt-med conventions, and served as a witness for the vaccine court.

Mr. Geier’s license to practice medicine was suspended last year. Since then he has tried a few avenues to get his ability to practice reinstated, at least while he is pursuing appeals. The Maryland State Board of Physicians has denied his request and issued a (second) cease and desist order informing him to stop practicing medicine.

Mr. Geier and his son, David Geier, took a theory from Prof. Simon Baron-Cohen: the “extreme male brain” concept of autism. Where Prof. Baron-Cohen focused on the effects of fetal testosterone levels on brain development, the Geier team somehow arrived at the idea that autistics have mercury bound in to testosterone in their brains. One can read an analysis of this theory at A Photon in the Darkness, Miscellaneous Mercury Nonsense. As you can imagine from the title of that article, the autism/mercury/testosterone idea was an obviously bad idea from the start.

Unfortunately, the Geiers took this bad idea from theory to practice. They further hypothesized that these mercury/testosterone sheets prevented chelators from removing the mercury. So, they futher hypothesied, by reducing the amount of testosterone in the body, the mercury bound in these supposed mercury/testosterone sheets would be released allowing chelators to remove the mercury. Why lower levels of testosterone would lead to these supposed mercury/testosterone complexes breaking down is not well explained. Which is another way of saying it doesn’t make sense.

It is worth noting that these sheets, or matrices as the Geiers dubbed them, of mercury and testosterone do exist. In laboratories. After boiling mercury compounds in beakers of benzene. As Prometheus wrote back in 2006:

This is not a condition even remotely similar to anything found in living tissue – of any vertebrate species. In other words, it isn’t likely to happen in autistic children unless you dissolve them in hot benzene.

Basically every link in their logic chain was bad. But this did not stop the Geiers from applying Lupron as a treatment. The drugs for reducing testosterone production (such as Lupron) are expensive. Insurance doesn’t pay for Lupron to reduce testosterone levels in disabled children so that non-existent mercury/testosterone sheets will break down by some unexplained mechanism so that chelators can remove the mercury which is not really linked to autism. Probably because of the insurance angle, the Geier’s prescribed Lupron and similar drugs not for the supposed ability to help the chelating process, but to treat precocious puberty. Early onset of puberty.

According to the Maryland Board, based on records and testimony from patient’s parents, the Geiers failed to do the basic work involved in diagnosing precocious puberty and, in some cases, diagnosed precocious puberty in children who were old enough to be going through puberty.

Sound complicated? They were diagnosing precocious puberty without the proper tests in children who didn’t have it in order to prescribe drugs to reduce testosterone levels so that mercury/testosterone sheets which don’t exist in their brains will break down and allow a chelator to remove the mercury which doesn’t cause autism.

Lupron is not a mild drug. It reduces sex hormones and delays puberty. Children are supposed to go through puberty at a given time in their lives and delaying it comes at a cost. In addition the drug itself has side effects. From the recent decision upholding the suspension of Mr. Geier’s license:

Lupron treatment carries a very high risk of skin abscesses and infections, and it is contraindicated in patients with a history of seizures. Dr. Geier nevertheless prescribed it for Patient B, who had a history or uncontrolled seizures. Nor did Dr. Geier perform all of the necessary diagnostic procedures before prescribing Lupron. Nor did Dr. Geier physically examine Patient B until almost three years after he began prescribing for him. See Proposed Decision at 33, 37-38. This is only one example of the truly risky behavior that Dr. Geier engaged in with these patients.

Mr. Geier’s license to practice medicine was suspended last year by the Maryland Board of Medical Practice. He tried to defend himself in a series of actions since, with this action being the final word.

The Board “entirely agrees” with the a previous decision that allowing Mr. Geier to continue to practice medicine while awaiting the determination of formal charges raises the likelihood of serious harm to public health and safety:

The ALJ concluded that “allowing [Dr. Geier] to continue practicing medicine while formal charges are pending raises a substantial liltelihood of risk of serious harm to the public health, safety, or welfare.” The Board entirely agrees. For Dr. Geier to practice medicine at this time would constitute a danger to the patient community.(3)

The footnote (3) in the above statement was already quoted in this artice–look above to the paragraph on “Lupron treatment carries a very high risk…”

The Board repeated this position in their conclusion:

“I conclude that for all these reasons, the Patients’ health, safety or welfare was at risk of serious harm.. Further, the existence of all these problems throughout all the Records raises a substantial likelihood that the risk of serious harm to the Patients was also posed to many other children with autism treated by the Respondent. I find that this meets the necessary standard for summary suspension of the Respondent’s license: allowing him to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety, or welfare,”

One very troubling argument made by Mr. Geier was that he was not required to have an Institutional Review Board for his research. One of the charges against Mr. Geier involved an IRB he instituted–where he, his son, his wife, a patient’s mother and other interested parties were members of the IRB. The Board did not address whether such a board was required, but did dismiss the charge based on the lack of evidence put forth by the State. More discussion on the IRB can be found at Neurodiversity.com in the article An Elusive Institute.

The Respondent argued both that he was not required by federal law to have an Internal Review Board and, that even if he was bound by such a requirement, the State failed to produce any evidence that his board operated in a flawed manner. The State did not dispute this argument in its response to the Motion. I agree with the Respondent that the State failed to produce sufficient evidence to survive a motion for judgment on the allegations related to an Internal Review Board. See COMAR 28.02.01.12E. C’ Md. Rule 2-519. I will recommend that this portion of the Motion be granted and further recommend that paragraphs 157 through 162 of the Order for Summary Suspension be dismissed.

The thought that somene (Mr. Geier in this case) believes that research could be performed on anyone, not just disabled children, without the protection of an IRB is frightening.

In what is to this reader the most ironic statement by Mr. Geier in this action:

Finally, Dr. Geier accuses the ALJ of establishing a new and unwarranted standard for the medical care of children with autism. Again, Dr. Geier fails to acknowledge that the ALJ relied to some extent on the testimony of his own expert witnesses, and on his own sworn statement, to make her findings regarding the standard of care and the deficiencies in Dr. Geier’s practice.

Yes. Dr. Geier accuses the ALJ of establishing a “new and unwarranted standard for the medical care of children with autism.” Mr. Geier, who while he may not have been the first to promote chelation for autism has been one of the primary proponents, Mr. Geier is part of the team who invented the idea of Lupron as a part of a chelation protocol. A “new and unwarranted standard for medical care of children with autism”.

In addition to this decision, and the cease and desist order, Mr. Geier’s licenses to practice have been suspended in California, New Jersey, Indiana, Florida, Ohio, Washington and Virgina.

The Maryland Board accepted James Adams (a materials scientist) as an expert on chelation, at the behest of Mr. Geier. The opinions offered by Mr. Adams differ from those of medical toxicologists (a group of physicians trained and in practice to treat poisoning):

The Respondent [Geier] testified in his sworn statement that he orders chelation therapy for hispatients on “various” schedules “every other day or a few days on and a few days off for a couple of months – three months.” State’s Ex, 8 at 34. Yet, the Respondent’s expert on chelation, Dr. Adams, testified credibly that patients need an even longer break between rounds of chelation: three days of chelation followed by eleven days off. Dr. Adams also testified that chelation therapy should only be initiated after a patient is given a short “challenge” dose of chelation to ensure that the patient actually needs the therapy. If administered to a patient who does not need it, chelation poses serious risks of injury to the brain and other organs. It is imperative, therefore, that a physician only administer chelation on a limited basis to the patients who actually need it. The Respondent not only skipped the challenge step necessary to ensure chelation was even necessary, but then went full force into chelation therapy on an intensive schedule (with an experimental drug.not FDA-approved for that purpose) without appropriate rest breaks. In several cases, moreover, the Respondent failed to regularly monitor the effects of chelation, and in two cases he prescribed it for patients that he knew he could not monitor.

The concept of a “challenge test” for diagnosing mercury intoxication is covered by the American College of Medical Toxicologists in American College of Medical Toxicology Position Statement on Post-Chelator Challenge Urinary Metal Testing. Who concluded:

“It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

I hope that the Maryland Board looks into this issue of challenge testing before ruling again on such issues.

Mr. Geier is scheduled to give a talk at a large annual autism-parent convention. Last year, after the first action suspending his license, he was reportedly given a standing ovation at this convention. This reader is at a loss to understand why.

Seafood Consumption and Blood Mercury Concentrations in Jamaican Children With and Without Autism Spectrum Disorders.

12 Apr

In yet another study on mercury and autism, a team from the University of Texas has investigated blood mercury levels in children with autism spectrum disorders (ASDs). In Seafood Consumption and Blood Mercury Concentrations in Jamaican Children With and Without Autism Spectrum Disorders they report that “After controlling for the child’s frequency of seafood consumption, maternal age, and parental education, we did not find a significant difference (P = 0.61) between blood mercury concentrations and ASDs. ”

“we did not find a significant difference between blood mercury concentrations and ASDs”

Here is the abstract:

Mercury is a toxic metal shown to have harmful effects on human health. Several studies have reported high blood mercury concentrations as a risk factor for autism spectrum disorders (ASDs), while other studies have reported no such association. The goal of this study was to investigate the association between blood mercury concentrations in children and ASDs. Moreover, we investigated the role of seafood consumption in relation to blood mercury concentrations in Jamaican children. Based on data for 65 sex- and age-matched pairs (2-8 years), we used a General Linear Model to test whether there is an association between blood mercury concentrations and ASDs. After controlling for the child’s frequency of seafood consumption, maternal age, and parental education, we did not find a significant difference (P = 0.61) between blood mercury concentrations and ASDs. However, in both cases and control groups, children who ate certain types of seafood (i.e., salt water fish, sardine, or mackerel fish) had significantly higher (all P < 0.05) geometric means blood mercury concentration which were about 3.5 times that of children living in the US or Canada. Our findings also indicate that Jamaican children with parents who both had education up to high school are at a higher risk of exposure to mercury compared to children with at least one parent who had education beyond high school. Based on our findings, we recommend additional education to Jamaican parents regarding potential hazards of elevated blood mercury concentrations, and its association with seafood consumption and type of seafood.

Members of this team have other work on autism in Jamaica. Last year they presented Paternal and Maternal Age Are Jointly Related to Autism Spectrum Disorders In Jamaican Children at IMFAR. which had goals of:

This study’s primary objectives were to investigate whether environmental exposures to mercury, lead, arsenic and cadmium play a role in autism. Additionally, we investigated other potential risk factors for autism, including maternal and paternal age

So we see that the recently released paper is part of the conclusion of that study, which was incomplete at the time of abstract submission for IMFAR. I believe this team is reporting again at IMFAR 2012.

Why bring this up? It’s a relatively small study on a topic that has been well covered in the past: autism risk and mercury exposure. Besides, do even supporters of the autism/mercury hypothesis think that blood levels of mercury are a good indicator to track? The answer is “yes” when blood levels might implicate mercury and “no” when blood levels do not (as is this case).

The mercury/autism hypothesis has a long history, but it is worth noting that there was a great deal of excitement a few years ago when a researcher claimed that by re-analyzing an existing dataset she could show a correlation between blood mercury levels and autism. Porf. DeSoto’s 2007 paper was Blood Levels of Mercury Are Related to Diagnosis of Autism: A Reanalysis of an Important Data Set. The re-analysis was criticized (e.g. Autism Street’s A Tale Of Two Tails and A Photon in the Darkness’ Winter Potpourri). As noted, the re-analysis was also welcomed in some circles, including an article by Age of Autism’s Mark Blaxill: When Smart Scientists Make Stupid Mistakes:

This is an important and unexpected finding. It supports one of the central hypotheses at the heart of the autism-mercury controversy and suggests that the excretion deficit in autistic children might persist longer than anyone had guessed.

The idea that correlations between blood levels in autistics could be “an important…finding” was downplayed a great deal a few years later after Prof. Hertz-Picciotto’s team at the U.C. Davis MIND Institute came out with a study, Blood mercury concentrations in CHARGE Study children with and without autism. The MIND team concluded, “After accounting for dietary and other differences in Hg exposures, total Hg in blood was neither elevated nor reduced in CHARGE Study preschoolers with AU/ASD compared with unaffected controls, and resembled those of nationally representative samples”. Key in that conclusion–“after accounting for dietary and other differences in Hg exposures”. This is something that was not done in the dataset that Prof. DeSoto re-analyzed.

Which led to a press release from Mr. Blaxill’s organization, SafeMinds: New California Study on Children’s Blood Mercury Levels Leaves Unanswered Questions About Mercury’s Role in Autism which downplayed any impact of the MIND study while somewhat ironically using DeSoto’s re-analysis for support. In other words, new research on blood-levels of mercury are not so important because we have older, uncontrolled, data which does say blood-levels are important.

More telling of the shift in support for blood mercury concentrations is this 2010 comment from Katie Wright at the Age of Autism:

Measuring random blood levels is a fruitless exercise, like testing ASD kids for grass allergies in the wintertime.

Don’t assume the door was closed on blood levels of mercury. In 2011 a paper was published, Theoretical aspects of autism: Causes—A review, which stated that there was evidence for a “metal metabolism disorder” in autistics and Supporting this relationship are reports documenting that heavy metals are increased in the blood and urine of autistic subjects”. This review was not surprisingly welcomed by groups promoting the idea that vaccines and/or mercury cause autism as well as criticized by many (for example)

So while, yes, these groups do welcome research indicating that blood levels of mercury are important in discussing autism research, they are also quite prepared to downplay using on blood-levels of mercury in studies which don’t support the mercury-causation idea.

Which is why one will not be surprised that research such as this new paper from Jamaica will have little impact on the mercury-causes-autism movement. Well, that and the fact that it is evidence against causation.

For those who claim that mercury testing should be done earlier–that testing autistic children is too late (“like testing ASD kids for grass allergies in the wintertime”) there is another study in process, one that was presented at IMFAR 2011. Prenatal and Neonatal Peripheral Blood Mercury Levels and Autism Spectrum Disorders which I don’t believe has been published yet. The conclusion from that study: “Levels of total mercury in serum collected from mothers during mid-pregnancy and in blood collected from infants at birth were not associated with risk of ASD.”

Mercury levels in pregnant women aren’t correlated to whether their children have autism. Mercury levels in newborns aren’t associated with autism risk. Blood levels in autistics are not correlated with their diagnosis. Add to this the fact that autism risk is not correlated to levels of mercury exposure from vaccines or immunoglobulins (e.g. Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism). And the fact that autism does not look like mercury intoxication. And that autism prevalence estimates continue to rise even after mercury was removed from vaccines. Why is there still support for this idea?

Why the next CDC autism rates spells bad news for the mercury hypothesis

22 Mar

A recent article on Disability Scoop discussed an upcoming CDC autism report. The MMWR’s(Morbidity and Mortality Weekly Reports) from the CDC have been one of the standards for autism prevalence for years. Each CDC prevalence estimate is calculated for a group of 8 year olds born in a certain year. For example, the last estimate was “Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, United States, 2006” for children born in 1998.

Every time a new CDC autism MMWR has come out, the prevalence estimates are higher. Every timer there are groups that point to the rising number of vaccines and mercury exposure from those vaccines. People point out that there is a correlation between mercury exposure (thimerosal) and the autism rates. The MMWR’s so far have been all for children born in the 1990’s, a period when the number of vaccines and the thimerosal exposure from those vaccines was increasing.

Here are the autism prevalence estimates from recent CDC reports:

2006 (birth year 1998) 9 per 1000
2004 (birth year 1996) 8 per 1000
2002 (birth year 1994) 6.6 per 1000
2000 (birth year 1992) 6.7 per 1000

Following this trend, the next report will be for children born in 2000, age 8 in 2008. From the perspective of testing the vaccine hypothesis, in particular the mercury/thimerosal hypothesis, this is the start of a new era. In 1999 the AAP recommended that thimerosal be removed from vaccines. By 2001, all infant vaccines with the exception of influenza were produced only in thimerosal-free versions. This means that children born in 2000, the cohort the CDC will likely report upon, received, on average, a lower exposure to thimersal than the previous groups.

If the mercury hypothesis were correct (and there already a great deal of evidence to say that it is *not* correct) the autism rate should go down. At the very least, it should stay the same as the group before–about 0.9%.

Of course we will hear claims like “but not all the thimerosal containing vaccines were gone for this group” and “but what about the influenza vaccine?” and more obvious excuses in case (at it seems likely) the prevalence goes up again.

All of these avoid the fact that the average thimerosal exposure will be much lower for this group than the previous (1998 birth year) group. The excuses amount to…well…how about a visual?

With thanks to Reuters for the image I am using.

Yes, goal posts will move. Nice idea putting them on wheels. Could save a lot of effort, but those promoting the mercury idea are already used to moving goalposts.

And what if the CDC also reports on birth year 2002 (they have reported two birth cohorts at the same time in the past)? Those goalposts might to have to move quite a bit.

Now consider a different perspective. Consider that each CDC report has been an undercount. They don’t do a “whole population” survey like was done in Korea recently. They don’t test all children, they rely upon records already in existance. The last CDC report found that about 23% of the children identified as autistic in the study did not have a diagnosis before the study. Clearly the United States has not been identifying all the autistics in the population. Given this, the rising autism prevalence estimates (and, yes, they are *estimates*) could be seen as an accomplishment. This is a position put forth by Prof. Richard Grinker. The rising prevalence estimates reflect a the U.S. getting better at identifying the autistic students in our schools.

COALITION FOR MERCURY-FREE DRUGS (COMED, INC.) v. SEBELIUS

15 Mar

The Coalition for Mercury Free Drugs (CoMeD) is an organization run by Mark and David Geiers. This is the father/son team which has promoted some of the most questionable research trying to link autism (and more) to mercury, especially in vaccines. They are also notorious for their “lupron protocol”, a therapy where a strong drug is used to reduce sex hormones in a bid to remove heavy metals from the body (if this doesn’t make sense to you, don’t worry about your understanding. It doesn’t make any sense).

CoMeD petitioned the secretary of health and human services (Kathleen Sebelius) to stop all use of thimerosal containing vaccines. The original petition was denied, and, now, Their appeal was dismissed.

We recognize plaintiffs’ genuine concern about thimerosal-preserved vaccines. But plaintiffs are not required to receive thimerosal-preserved vaccines; they can readily obtain thimerosal-free vaccines. They do not have standing to challenge FDA’s decision to allow other people to receive thimerosal-preserved vaccines. Plaintiffs may, of course, advocate that the Legislative and Executive Branches ban all thimerosal-preserved vaccines. But because plaintiffs are suffering no cognizable injury as a result of FDA’s decision to allow thimerosal-preserved vaccines, their lawsuit is not a proper subject for the Judiciary. We affirm the judgment of the District Court.

The decision ended simply: “We affirm the District Court’s judgment dismissing plaintiffs’ suit for lack of standing.”

Financials for Andrew Wakefield’s Strategic Autism Initiative

15 Mar

Non profit organizations in the United States have to file tax forms and those become part of the public record. After leaving Thoughtful House, Andrew Wakefield formed a non-profit called the “Strategic Autism Initiative” (SAI). That was in 2010. The tax forms (form 990) don’t become public right away, so the form for 2010 has been only recently made available, and is available here.

Since the SAI was formed in 2010, we don’t know how much of the year they were paying salaries (for example).

They pulled in $226,000. We know $100k was from Generation Rescue from their form 990.

Wakefield was paid $16,667. But we don’t know for how many months. SAI was formed in 2010, so it is a partial salary. He claims 30 hours/week.

Assume the $16,667 is one month’s salary. That works out to $200k/year at 30 hr/week. That’s the equivalent of nearly $270k for a full-time (40 hour per week) which was his salary at TH before he was let go.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota. They spent about $30k on this project, which is supposed to include prevalence studies in Somalia.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota working on this. They spent about $30k in each location on this project, which is supposed to include prevalence studies in Somalia.

As to the people involved with the SAI:

Andrew Wakefield is president
James Moody is VP
Terri Arranga is secretary
Mark Blaxill is treasurer
Polly Tommy is director
Phil Rawlins is director

Only Wakefield and Arranga are paid (Arranga was paid $2,400 in 2010, listed as putting in 15 hours/week)

They spent $5K in legal fees. $25k in advertising.

It will be interesting to read the 2011 form 990 when that is available. For one thing, this will give salary information for a full year. Also to see how well they do collecting donations. $250k is impressive for a first year. As already noted, $100k is from Generation Rescue. How much of the rest is really just a transfer from other vaccines-caused-an-autism-epidemic orgs is unknown.

← Older Entries
Newer Entries →