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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.”

Mark Geier: Cease and Desist

26 Feb

From the Baltimore Sun: ‘Cease and desist’ order issued against autism doctor

Dr. Mark R. Geier, a Rockville doctor accused of improperly treating children with autism, has been ordered by the state Board of Physicians to stop practicing medicine while his license is suspended.

The doctor’s license was suspended in April after the board concluded his hormone and chelation therapy endangered the children in his care. But the board in a new “cease and desist” order this week accused the doctor of refilling prescriptions for at least three patients in violation of the suspension.

The doctor has appealed the suspension of his license. His lawyer declined to comment on the newest claims.

A Comparison of Urinary Mercury between Children with Autism Spectrum Disorders and Control Children

16 Feb

Researchers are still looking at the question of whether autism is caused by mercury intoxication. One of the measures used in the past is to check the mercury content in the urine of autistic and non autistic children. Claims have been made that autistic children are “poor excretors” of mercury. This is defined as “more mercury in the urine than other children” or “less mercury in the urine of other children”.

A group of researchers from the UK and US have tested a group of autistic children, special needs non autistic children, siblings and regular school children. What did they find? No difference.

Background

Urinary mercury concentrations are used in research exploring mercury exposure. Some theorists have proposed that autism is caused by mercury toxicity. We set out to test whether mercury concentrations in the urine of children with autism were significantly increased or decreased compared to controls or siblings.

Methods

Blinded cohort analyses were carried out on the urine of 56 children with autism spectrum disorders (ASD) compared to their siblings (n = 42) and a control sample of children without ASD in mainstream (n = 121) and special schools (n = 34).
Results

There were no statistically significant differences in creatinine levels, in uncorrected urinary mercury levels or in levels of mercury corrected for creatinine, whether or not the analysis is controlled for age, gender and amalgam fillings.

Conclusions

This study lends no support for the hypothesis of differences in urinary mercury excretion in children with autism compared to other groups. Some of the results, however, do suggest further research in the area may be warranted to replicate this in a larger group and with clear measurement of potential confounding factors.

There were outliers of high mercury content in the special needs children (both autistic and non autistic). Expect those promoting the autism/mercury connection to focus on those children and to build connections between the funding agencies and pharmaceutical companies.

The Omnibus Autism Proceeding: effectively over

21 Jan

The Omnibus Autism Proceeding (OAP) was held in the U.S. Court of Federal Claims to group the large number of claims filed involving autism and vaccines. The Docket was opened on July 3, 2002, nearly 10 years ago. The last entry was placed 1 year ago. Since then many cases have been dismissed. About half the cases are left to hear, but the fact that the two causation theories presented (that the MMR vaccine causes autism and that Thimerosal causes autism) were both found to have no merit (“not even close” one special master put it) and no new theory is proposed by the Petitioners’ Steering Committee (the attorneys who presented the case for the petitioners) makes it clear that the group claim, the omnibus, is effectively over.

That is not to say that other claims are not proceeding through the court, or that new cases will not be presented. There is at least one case pursuing the idea of mitochondrial dysfunction and autism, as with the Hannah Poling case. ([edit to add–the case ongoing, which was briefly closed, is not the Hannah Poling case. See the comments below). The case was actually dismissed for lack of action by the petitioners but the special master allowed it to continue again).

Looking back, the Omnibus peaked in 2003 when 2,437 cases were filed (close to 1/2 of the total that would eventually be filed).

Is Mark Geier finished as an expert witness in the vaccine court?

10 Dec

Dr. Mark Geier is a name which has come up frequently in the autism/vaccine discussion, and in alternative medical therapies (such as Lupron) of autism. Dr. Geier has been an expert witness for petitioners in the vaccine court for about two decades. He has been criticized by the court for almost as long. Dr. Geier has recently had his medical license suspended.

Mark Geier and his son David have worked for the Petitioners Steering Committee (the lawyers handling the plaintiffs’ cases in the Autism Omnibus). But their relationship seems a bit strained. They filed suit asking for $600,000 in payment. The Geiers have had previous requests for fees drastically reduced or denied, including one where they expected the Court to cover $20,000 as their costs (and hourly rate, including while sitting on planes) to attend conferences in Italy and France. The court called this “a complete abdication of billing judgment.”

In a recent court decision, Dr. Geier has been criticized again. Thoroughly. But this very strong statement from the special master makes it clear that Dr. Geier’s future as an expert witness or consultant will be very restricted:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

The decision focused on expenses the Petitioner’s Steering Committee (PSC) charged in the Omnibus Autism Proceeding for Mark Geier, his son David Geier and their colleagues. Much of these charges resulted from a study they published, Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. Epiwonk (a former professional epidemiologist for the CDC) discussed the paper in New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?

The study noted in the acknowledgements that the study was funded by the PSC:

This study received funding from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).

The Geier/Young team billed the PSC, and the PSC billed the vaccine injury trust fund vaccine court. As you can read, they just weren’t successful.

The Geiers tried some fancy footwork to get the Young-Geier study paid for by our tax dollars.  Including an apparent attempt to get the non-doctor David Geier compensated by charging work at their company, “medcon”, rather than naming David Geier as the recipient.

Bottom line–the PSC asked for $440k to compensate the people who worked on the Young-Geier study.  They got $33k, and a strong statement that Geier will be unlikely to be compensated by the program in the future.

If you are curious about the value of the study itself, there is a whole section of the decision titled “The Young-Geier article itself did not add any value to the petitioners’ causation case.”

In their application, the PSC sought a total of $7,202,653 for interim fees and costs. with $1.35M for costs, primarily expert witness costs (note that the Geiers did not actually serve as witnesses, so they are part of the “costs”)

Out of $1,350,000 in costs one might ask how much of this was for the Young-Geier study?

As noted above, this Decision on Remand concerns the PSC’s claim for compensation for amounts paid, or to be paid, to four experts/consultants: Dr. Mark Geier, David Geier, Dr. Heather Young and Dr. Robert Hirsch. Conceptually, this claim can be broken into two parts. First, petitioners seek $447,004.02 to compensate all four of those individuals for work on an original medical article that was published in 2008. Second, petitioners seek $197,823.94 more for miscellaneous additional services provided by Mark Geier and David Geier between 2003 and 2008.

$447K. One third of the total. A large number of expert witnesses actually produced reports and testified, but the Geier team was to receive 1/3 of the total. If you take a high rate of $500/hour, this works out to 22 full time man weeks. For a study where they didn’t have to collect data, just analyze it. I find it difficult to believe this study took 22 weeks (or more, as the $500/hour is a very high estimate).

The Geiers were not slated to get the majority of the money. Heather Young, an associate professor at George Washington University, was to get the lion’s share. About a quarter of a million dollars:

Petitioners would receive $248,636.91 to compensate Dr. Young, $157,407.11 for the two Geiers, and $41,000 for Dr. Hirsch

Unless GWU pays their associate professors much more than is common, this represents well over one year’s pay for Prof. Young.

Thankfully HHS (respondent) argued against this request:

Respondent argues strenuously, in response, that it would be wholly unreasonable for the Program to provide compensation to these individuals for their efforts concerning the article.

Is it reasonable to charge for studies created for litigation? Are they of high value to the case?

I note that the Supreme Court has expressed the view that medical studies produced expressly for litigation purposes should be viewed with skepticism.

and

The views of these courts, then, reinforce the concern that if a lawyer involved in a Vaccine Act case chooses specific experts and pays them to carry out a study, the potential is great for bias in the study, toward the outcome that would assist the clients of the lawyer paying for the study. Thus, it is arguable that, as the respondent contends, it would be poor public policy, in general, for special masters to award public funds for such original studies.

and

Rather, I conclude that under all the specific circumstances of this case, it would not be reasonable for me to compensate the named individuals for the production of this particular article.

The PSC argued that the paper was not “litigation driven”.  The SM didn’t accept the argument:

As to the former point, I am simply not persuaded by the suggestion that the article was not litigation-driven….The mere fact that the PSC lawyers contributed or promised monetary support for another article co-authored by the Geiers, concerning the topic of whether thimerosal-containing vaccines can cause autism, is itself strong evidence that the article was litigation-driven.

Further, the very fact that the petitioners are now seeking Vaccine Act funds for the cost of producing the article is a very strong indication that the article was litigation-driven.

If that wasn’t enough, the PSC argument backfired in another way:

If the article was produced “completely apart from [Dr. Geier’s] involvement in this [Vaccine Act] litigation,” and would have been produced even absent that litigation, that would seem to contradict the petitioners’ claim that paying the cost of producing the article was a necessary and reasonable cost of the Vaccine Act litigation.

How was the Young-Geier study used in the Omnibus? Was it persuasive? Answer: it wasn’t really used and it wasn’t persuasive.

The HHS/DOJ’s experts were critical of the Young-Geier study:

Perhaps the strongest factor leading to my result here is my conclusion that the Young-Geier article itself did not add any value to the petitioners’ causation presentation in this case. Two epidemiologic experts, both of them testifying for respondent, testified at the trial in this case concerning the merits of the Young-Geier article, and both testified that the article was deeply flawed.

Even the PSC’s own experts were not impressed by the Geiers in general:

And, very significantly, none of the petitioners’ five medical experts who testified at the trial offered any testimony in support of the validity of the Young-Geier article. It is especially striking that among petitioners’ experts was an expert who has excellent credentials in epidemiology, Dr. Sander Greenland. Dr. Greenland in fact testified negatively about the Geiers’ prior epidemiologic articles concerning the vaccine-autism controversy, describing those studies as“deficient in methodology.”

Prof. Greenland didn’t speak to the Young-Geier article directly, just their methods in other studies.  But the special master points out that this appears to be a trick on the part of the PSC to avoid having to defend the Young-Geier study on cross examination:

Yet they [the PSC] put Dr. Greenland on the witness stand in this King case on May 12, 2008 (Tr. 69-135), did not ask him about the article, and did not reveal the existence of the article to the special masters and respondent until May 16 (see fn. 6 above), thus ensuring that no one could ask Dr. Greenland about the Young-Geier article. From these circumstances, the most reasonable inference is that petitioners’ counsel deliberately intended to avoid any questioning of Dr. Greenland, their epidemiologic expert, about the Young-Geier article.

The special master concludes that the study did not add any value to the PSC’s case and “no rational hypothetical paying client” would have agreed to pay for the production of such a “flawed study”:

In short, the Young-Geier study itself was severely criticized by respondent’s experts, who articulated persuasive reasons for that criticism. In my own analysis, the Young-Geier study also appears flawed. And the other special masters who reviewed that article reached the same conclusion. Clearly, no rational “hypothetical paying client” of the PSC would have agreed to pay for the production of such a flawed study. Thus, the fact that the Young-Geier article did not add any value to the petitioners’ causation presentation in this case is a very strong reason why I should decline to compensate the PSC for the cost of producing the article.

The Special Master notes that given the long history of the Geiers in the vaccine program, it would be unreasonable to expect the program to pay for the cost of the study:

A review of prior legal opinions discussing the Geiers casts strong doubt on the reasonableness of compensating the cost of an article co-authored by them.

The Special Master then goes into detail of those decisions , with an entire section  of the decision dedicated to “Vaccine Act opinions concerning the general credibility of Dr. Geier as an expert witness” including subsections “Criticisms of Dr. Geier for offering testimony outside his area of medical specialty” and “Opinions questioning Dr. Geier’s honesty, candor, or veracity” and “Opinions declining compensation or substantially reducing compensation for Dr. Geier’s services”

If you get the time, read through those. They are highly critical. A condensed version of 20 years of highly critical comments about the actions of the Geiers in the vaccine program (mostly Mark Geier):

Criticism of the Geiers is not limited to their activities in the Vaccine Court. In “Judicial opinions outside of the Vaccine Act” they quote decisions stating “federal appellate court concluded that Dr. Geier gave erroneous testimony” and “state court found Dr. Geier’s testimony to be “unsubstantiated” and unpersuasive” and “federal court was “unimpressed with the qualifications, veracity, and bonafides” and, lastly, “federal judge stated that he was “unconvinced” that Dr. Geier was qualified to offer testimony concerning certain vaccine safety issues.”

The Special Master went into detail about previous flawed studies by the Geiers on vaccines and autism.  He also notes that the assertion that Dr. Geier is qualified as an epidemiologist is not supported:

Thus, Dr. Geier does not appear to have had any formal academic training or degrees or medical faculty experience in epidemiology, and his medical experience has been chiefly in genetics rather than epidemiology. Thus, it is unclear why he was named a “Fellow” of the American College of Epidemiology, and it is doubtful whether he should be considered an expert in epidemiology. I conclude that the petitioners have failed to shoulder their burden of demonstrating that Dr. Geier should be considered an expert in epidemiology.

and

Further, a number of judges and special masters have also examined Dr. Geier’s credentials, and have specifically concluded that Dr. Geier should not be considered an expert in epidemiology.

He awards fees, as a consultant not expert, for Mark Geier’s other efforts on the Omnibus:

Accordingly, I awarded $33,130.35 (147.246 hours times $225 per hour) for the services of Dr. Geier.

No mention of payment for David Geier or Heather Young.

The Special Master makes it clear that even this amount was grudgingly awarded. Given that *in the past* it was reasonable to hire Mark Geier as a consultant:

I note that it is not an easy judgment whether to award any funds for the services of Dr. Mark Geier in this case. On balance, I conclude that, in light of the cases awarding funds to Dr. Geier as a consultant (see p. 33 above), it was not unreasonable in this instance (several years ago) for the PSC to employ Dr. Geier for consultant services.

But, after 20 years, the vaccine program may have had enough of Mark Geier:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

(emphasis added)

If the court won’t pay his fees, the career of Mark Geier as an expert for vaccine injury cases is over. His son David is not likely to be taking his place, as he has not been considered even viable as a consultant by the special masters. As noted above, Mark Geier’s license to practice medicine has been suspended (in multiple states). David Geier was charged with practicing medicine without a license. One has to wonder if or how the Geiers will re-emerge on the autism/vaccine scene.

Defending alternative medicine and autism: the charges against Anju Usman

14 Oct

In Illinois charges DAN doctor with unethical behavior, LBRB writer Ken Reibel discussed the case recently brought against alternative medical practitioner Dr. Anju Usman. These charges follow on a civil suit brought by the parent of an autistic child seen by Dr. Usman. This charges in this case will require that Dr. Usman defend many of the common practices in alternative medicine.

The complaint is:

DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION of the State of Illinois,

v.

ANJUM I. USMAN, M.D.

No. 200904994

One short paragraph in the complaint sums up a big piece of where this suit has the possibility to strongly influence how alternative medicine “treats” autism: None of the treatments described above has been proven to influence the course of autism.

Here is a section of count 1:

17. Hair analysis does not provide a basis for the diagnosis of heavy metal toxicity.
18. Provoked urine testing does not provide a basis for the diagnosis of heavy metal toxicity. The American College of Medical Toxicology has determined that provoked testing has not be scientifically validated, has no demonstrated benefit and may be harmful when used for assessing patients for metal poisoning.
19. Porphyrin testing does not provide a reliable basis for the diagnosis of heavy metal toxicity.
20. Although chelation therapy is FDA-approved for treating lead poisoning, it should not be used unless a non-provoked blood (not urine) test shows an extremely high level of lead.
21. Respondent did not obtain a confirmatory blood lead test or record any source of lead exposure.
22. The record contains no basis for concluding that chelation therapy was appropriate.
23. The record does not contain adequate infonlled consent for any of the prescribed nonstandard tests or treatments. The consent fonns used did not accurately present the risks and/or benefits of tests and treatments. Although it mentioned experimental drug use, these were not administered as part of a proper experimental protocol.
24. The informed consent form states that chelation therapy “is considered controversial for the generalized treatment of chronic low or high level lead toxicity, mercury toxicity, or for other heavy metal toxicities, either acute or chronic.” This statement is misleading because there is a clear scientific consensus that it is inappropriate for treating lead toxicity without demonstrating that toxicity exists and that the level is very high.
25. Throughout the treatment period, Respondent made statements to AC’s mother that the prescribed treatments had positive clinical benefits for children with autism, despite the lack of empirical research supporting Respondent’s position.
26. The record does not document any reason why AC should have received unproven treatments.
27. Spironolactone, which is potentially dangerous, was prescribed without justification.
28. Despite a nonnal selenium level, Respondent repeatedly and unnecessarily prescribed selenium supplements and continued to do so even when AC eventually showed a high level.
29. That Respondent abused the physician/patient relationship by taking unfair advantage of a patient’s vulnerability in that Respondent utilized unproven drugs and medicine to treat AC, a pediatric patient diagnosed with autism.
30. That the foregoing acts and/or omissions of Respondent are grounds for revocation or suspension of a Certificate of Registration pursuant to 225 Illinois Compiled Statutes (2002), Section 60122(A)(20), relying on the Rules for the Administration of the Medical Practice Act, Illinois Administrative Code Title 68, Section 1285.240(b)(1 )(C), and (2) (C).

There are many methods by which “heavy metal toxicity” is diagnosed by alternative medical practitioners. These methods are not demonstrated to be accurate, and are not accepted by actual medical toxicologists. These include hair analysis, provoked urine testing and porphyrin testing.

A prime example is provoked urine testing. A thorough discussion can be found here. A provoked urine test involves giving an individual a chelator and then testing the urine for heavy metals. Everyone (every thing, every animal) has some level of mercury. A chelator will force the body to excrete some level of the heavy metals inside, so it is no surprise that the levels obtained are “elevated”. The problem is that there is no standard by which one can compare the provoked urine to determine if the person actually has heavy metal poisoning.

The method is also called “challenge” testing. The American College of Medical Toxicologists have a position statement on this:

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.

More quotes from the complaint:

From Count III

That Respondent made false or misleading statements regarding the efficacy or value of the medicine, treatment, or remedy prescribed by Respondent in the treatment of any disease or other condition of the body in that Respondent made false or misleading statements regarding the efficacy of chelation therapy in the treatment of autism.

From Count V

29. That Respondent engaged in a pattern of practice or other behavior that demonstrates incapacity or incompetence to practice in that Respondent:
a. Repeatedly prescribed and administered unproven and medically unnecessary treatments to AC despite the lack of empirical research demonstrating the effectiveness of the prescribed treatment plans; and
b. Demonstrated extreme departure from rational medical judgment in the care and treatment of AC.

This isn’t a criminal complaint. Rather it is an ethics or “professional regulation” complaint. The disciplinary action called for if the case is proven involves Dr. Usman’s license:

WHEREFORE, based on these allegations, the Department of Financial and Professional Regulation of the State of Illinois, by Laura E. Forester, its Chief of Medical Prosecutions, prays that the Physician and Surgeon license of ANJUM I. USMAN, M.D., be revoked, suspended, placed on probation or otherwise disciplined.

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