Recently in Pediatrics Category
A big HT to the neurodiversity weblog on this story.
The medical license of Mark Geier, MD, PhD—whose dubious studies of and conclusions about autism (particularly with respect to the thoroughly debunked risks of vaccination) have been criticized ad nauseum at this blog—was suspended in Maryland. The state's medical board issued its 48-page order last week, April 27th.
The board concluded "that the public health, safety, or welfare required emergency action." The board's review was prompted by complaints from a concerned citizen (in 2006), a referring pediatrician (in 2008), and the mother of a former patient (in 2008). In October of last year, a "peer review" was conducted of 9 of 11 patient cases referred by the board.*
Among the board's peer-reviewed findings:
- Mark Geier falsely claimed to be a board-certified geneticist and board-certified epidemiologist.
- He "misdiagnosed six (6) of the nine (9) autistic children...with precocious puberty," whose care was reviewed.
- He treated these misdiagnosed children with Lupron or chelation therapy or both, which "exposed the children to needless risk of harm."
- Mark Geier's "assessment and treatment of autistic children...far exceeds his qualifications and expertise." Moreover, his ordering of laboratory tests was determined to be "outside the standard of quality care," and he "failed to conduct adequate physical examinations of any of the patients..." (It is noted in at least one instance that Mark Geier recommended Lupron therapy on the sole basis of a phone consultation.)
- Mark Geier "failed to provide adequate informed consent to the parents of the autistic children he treated."
In summary, the board wrote,
The Respondant [Mark Geier] endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.
A "post-deprivation" hearing has been scheduled for May 11th, and Geier may request an "evidentiary hearing" if he is dissatisfied with the result.
The order also reveals that Mark Geier holds licenses to practice medicine in numerous other states, including California, Florida, Hawaii, Illinois, Indiana, Kentucky, Missouri, New Jersey, Virginia, and Washington. Reciprocity actions in these states are unclear (to me); some license suspensions may be automatic, others may require hearings.
The board's order also strongly suggests that Mark Geier's son, David, who has only a bachelor's degree, is practicing medicine (ie, making diagnoses) without medical training or licensure. Nevertheless the board did not comment further on any actions against David Geier for this presumed unlicensed activity.**
The published work of Mark Geier (along with that of his son, David) has been criticized extensively at this blog and elsewhere (for relevant posts at Pathophilia, search for "Geier.")
* The peer-review organization declined to offer an opinion in 2 cases, citing that the care provided was beyond their scope of expertise. (Ha. Would it be that Mark Geier had the same reservations in judgment.)
** It is not clear if unlicensed medical practice in Maryland is within the scope of the medical board or if it is the purview of the state's criminal justice system.
05/05/11 update: The Chicago Tribune reported yesterday that the Illinois Department of Professional Regulation could only suspend Mark Geier's Illinois medical license if there was an "imminent danger" to Illinois patients or if the Maryland board takes permanent action (presumed here to be license revocation). This information came by way of Sue Hofer, the public information officer for the IDPR.
The IDPR's website indicates that "Mark Robin Geier" obtained a physician license in Illinois on October 30, 2008, which expires July 31, 2014.
Online searches for Mark Geier's medical licenses at other state's web sites provide the following information, tabulated by Pathophilia:
|
State |
Issue Date |
Expiration Date |
|
California |
07/01/2010 |
05/31/2012 |
|
Florida |
12/17/2008 |
01/31/2013 |
|
Hawaii |
11/07/2008 |
01/31/2012 |
|
Illinois |
10/30/2008 |
07/31/2014 |
|
Indiana |
10/10/2008 09/23/2009* |
06/30/2011 06/30/2011 |
|
Kentucky |
01/05/2010 |
02/29/2012 |
|
Maryland |
09/20/1979 |
Suspended 04/27/2011 |
|
Missouri |
10/14/2009 |
01/31/2012 |
|
New Jersey |
04/02/2009 |
06/30/2011 |
|
Virginia |
10/01/1992 |
05/31/2012 |
|
Washington |
12/01/2008 |
05/03/2013 |
* For "CSR-Physician."
They seemed like good, though not particularly original, ideas at the time: Initiate a med-pharma blog and inaugurate the coming new year with the top 10 stories from the waning year.
Seemingly good ideas can become millstones with time; nevertheless, these 2 particular self-inflicted burdens have been carried for at least another 365 days—to make a grand total of 3 years. Happy freekin' birthday, Pathophilia. Here's what really plagued, worried, or otherwise elevated our royal-we blog spirits in 2010.
No. 10: A Record-Busting Pertussis Outbreak in California.
Way to go, California parents who eschew routine childhood vaccinations.* Nice erosion of herd immunity. You've contributed to the worst statewide outbreak of pertussis (aka whooping cough) in the last 63 years. The last 63 years. Meaning since Truman was President. Meaning since Jackie Robinson broke the MLB color line.
Here's the latest from the California Department of Public Health while I/we simply stew in my/our juices of frustration:
- There have been 7824 confirmed, probable, or suspect cases of pertussis reported between January 1st and December 15th. (There were 9394 reported cases in 1947.)
- This year's pertussis incidence rate in California is 20.0 per 100,000, which is the highest rate in 52 years. (The rate was 26.0 cases per 100,000 in 1958.)
- There have been 10 deaths, 9 of which were Hispanic infants (who were too young to be immunized)
- Children younger than 6 months of age have been particularly vulnerable to disease.
- The California outbreak peaked in late July-early August, but "relatively high numbers of cases continue to be reported each week."
- Because a high level of herd (aka community) immunity is needed to reduce the incidence and spread of pertussis and the fact that vaccine-induced immunity wanes with time, a campaign to urge booster shots among adolescents and adults is ongoing.
- According to the CDPH, mothers or other close contacts are the most likely sources of pertussis for at-risk infants. The agency advises,
Thus vaccinating household contacts, health care personnel, and child care workers against pertussis is recommended at least 2 weeks before their contact with young infants. Increasing community immunity through widespread immunization will also decrease the chances that vulnerable infants will be exposed to pertussis. Immunization will also prevent debilitating cases of pertussis in older children, adolescents, and adults.
Unlike the historic California outbreak, which appears to be subsiding, a pertussis epidemic in upstate New York is gaining steam. It's now at the point at which the Public Health Agency of Canada is advising its citizens "to be on guard against" the disease in the United States. Yes, Canadian officials are now warning about infectious travel risks...south of the 49th parallel.
* Because of, largely, the disproven fears of vaccine-related autism.
Photo of symptomatic child with pertussis from pertussis.com.
A politically influential Florida chiropractor wants Mark and David Geier, proponents of the debunked link between the vaccine preservative thimerosal and autism and hawkers of chelation and Lupron, to have access to the state's confidential vaccine records. The Miami Herald has the infuriating story, and Kathleen Seidel at the neurodiversity blog provides substantial background. Among other things, Seidel reminds us of one very important and relevant fact: When the Geiers mined the CDC's Vaccine Safety Datalink for their dubious research in 2003 and 2004, they were accused of breaching patient confidentiality, and their work was temporarily halted as a result.
Another study showing that thimerosal—the ethylmercury-containing vaccine preservative—does not increase the risk of autism hardly seems necessary. For the rational majority, who are inclined to believe the results of credibly authored reports, there are at least 5 studies that fail to show a link between pre- or postnatal exposure to thimerosal and poor neuropsychologic outcomes or autism. (Moreover autism rates continue to rise despite the removal of thimerosal from childhood vaccines in 1999.) For the small group of irrational and very vocal citizens who maintain a causal connection between thimerosal and autism, no amount of negative data appears sufficient.
Nevertheless the results of a new case-control study, published in Pediatrics, are now available. And not only do they deny an increased risk of autism with thimerosal exposure (either in utero or later); they actually indicate that postnatal exposure to thimerosal significantly reduces the risk of autism—by about 40%. The authors (perhaps wisely) avoided speculating as to the reason for the reduced risk, however.
The case-control data were collected from children* enrolled continuously in 3 managed care organizations that participate in the CDC's Vaccine Safety Datalink. The study methods are distinctive in that the authors, in addition to mining electronic databases and medical charts, validated autism diagnoses in person and conducted parent interviews.
* 256 with autism spectrum disorder and 752 controls matched for birth year, sex, and MCO.
At the heart of Cedillo v. US DHHS was the claim that thimerosal-containing vaccines damaged Michelle Cedillo's immune system, which then allowed attenuated measles virus in the MMR vaccine to injure her brain, thereby causing autism. It's a convoluted (and medically illogical) argument, but one that was ostensibly supported, at least in part, by data from a questionable Dublin-based laboratory, Unigenetics.
In the original 2009 decision against the petitioner in the Omnibus Autism Proceeding,* Special Master George Hastings found the detection of vaccine-derived measles virus by Unigenetics in an intestinal sample from Cedillo "not reliable." The decision was based partly on expert testimony from Stephen Bustin, PhD, a UK-based molecular biologist who, as part of UK vaccine litigation, had obtained access to the Unigenetics laboratory and some of its relevant data. On the basis of a number of procedural flaws at Unigenetics, Bustin testified both in the UK and US courts that the company's work was plagued with potentially contaminating errors. Bustin also suggested that results from Unigenetics might even be fraudulent, after reviewing some of the laboratory's altered notebooks.
Access to documents from Unigenetics, on which Bustin based his expert opinion, was the crux of a recent appeal by Cedillo's parents to the US Court of Appeals for the Federal Circuit. This appeal was denied Friday, August 27th. And while the appeal court ruled that Special Master Hastings "erred in permitting the government to introduce the expert reports and testimony of Dr. Bustin because the government did not make available the underlying Unigenetics documents upon which Dr. Bustin relied," the court also noted that Hastings had given the petitioners virtually every opportunity to obtain this information from the UK court themselves, which they apparently did not try to do. (It should be noted that the government argued against the reliability of Unigenetics with other expert testimony. It is presumed on this basis that the Special Master's error was not a reversible one.)
In 2007, the government, in its case preparation, successfully petitioned the UK court to release the Bustin reports, but it did not request the laboratory notebooks or other data on which Bustin relied. The appellate decision further describes the background facts,
The government explained at oral argument that UK counsel informed them that an application to the UK court requesting "everything" from the UK litigation would be denied as overbroad, and as a result, they needed to narrow their request to the most essential items. The government therefore subsequently "honed down" their request to cover solely the three reports, two of which were filed by Dr. Bustin, that they eventually obtained.
The upshot: Cedillo v. US DHHS has been put to bed.
In a coda to this case, it can be said that life, outside the courtroom, moves relatively quickly and in curious directions. Unigenetics dissolved as a company 5 years ago, although its former director, pathologist John O'Leary, is evidently still working in Dublin at Trinity College. In 2008, O'Leary, in an apparent effort to regain academic credibility, was coauthor of a multi-institutional study ("Lack of association between measles virus vaccine and autism with enteropathy: a case-control study" in PLoS One) that essentially negated the results produced by his own company for Cedillo.
DHHS = Department of Health and Human Services; MMR = measles-mumps-rubella.* Which was affirmed by Judge Thomas Wheeler in the US Court of Federal Claims.
Advice for those fearful and fear-mongering parents who space out or delay vaccinations for their children: Don't.
The "too many, too soon" rant, which is predicated on the convoluted idea that multiple vaccinations overwhelm the immune system and thereby cause autism, has been thoroughly shot down by logical argument and now by a recent study in the journal Pediatrics.
Mining the Vaccine Safety Datalink, physicians at the University of Louisville in Kentucky compared the long-term neuropsychological outcomes of children who received on-time vaccinations during their first year with those who didn't. The cut-to-the-chase result: children who received timely vaccinations generally performed better and certainly no worse than less vaccinated kids. The study was based on a previous CDC study, which showed no association between exposure to thimerosal, a long-time vaccine preservative containing microgram amounts of ethylmercury, and autism.
At Medscape, CHOP pediatrician Paul Offit (Satan incarnate to antivaccinationists) offers his predictable and correct perspective on the study, saying,
I think parents can be reassured here that a choice to delay vaccines or to not give vaccines does not in any sense decrease the risk of a neurological outcome or autism. All it does is increase the period of time during which children are susceptible to vaccine-preventable diseases.
CDC = Centers for Disease Control and Prevention; CHOP = Children's Hospital of Philadelphia.
From Pediatrics: a study of tobacco poisonings in young American children.
- From 2006 to 2008, 13,705 cases of tobacco poisoning were reported.
- About 70% of cases occurred in kids younger than 1 year of age.
- Nearly 80% of poisonings were due to the ingestion of cigarettes and (or?) filter tips (vs smokeless tobacco or cigars).
Plus there's commentary on a charming, new Tic Tac-like product from RJ Reynolds: cinnamon- or mint-flavored Camel Orbs, which contain 1 mg of nicotine per pellet. Although the product is new to the market, there has been at least 1 reported case of tobacco poisoning due to the ingestion of Camel Orbs (by a 3-year-old child).
RJ Reynolds also markets flavored Camel Sticks and Camel Strips.
Last year, the FDA was given the authority to regulate flavored cigarettes (but not other flavored tobacco products), thanks to the Family Smoking Prevention and Tobacco Control Act. The agency was quick to ban candy-, fruit-, and clove-flavored smokes in the United States.
Image of Camel Orbs from dissolvables.tobaccopleasure.com.
Wow. A drug company actually downplaying its phase 2 data?
That's the charge of child neurologist Brenda Wong, an on-site investigator of PTC Therapeutic's ataluren (or PTC124) in muscular dystrophy, according to a report at MedPage Today.
Last month, PTC Therapeutics and its collaborator Genzyme announced that a treatment-related change in the primary endpoint, the 6-minute walk test, of a phase 2b trial of ataluren in Duchenne or Becker muscular dystrophy* (nmDBMD) did not reach statistical significance at 48 weeks. However, Wong, speaking at the just-completed annual meeting of the American Academy of Neurology in Toronto, said that patients treated with ataluren in the phase 2 trial experienced a mean improvement of 29 meters in the 6-minute walk test—which was just shy of the trial's prespecified target of 30 meters. This detail and others were not provided by PTC in its official communication.
Wong also said that the endpoint difference between ataluren- and placebo-treated patients was significant, when a different statistical test (a ranked analysis of covariance) was used, instead of what was prespecified (a simple analysis). Another important outcome: low-dose ataluren was more effective at delaying a deterioration in mobility than high-dose ataluren—which was no better than placebo. Wong proposed that low-dose ataluren may be more effective, because it has a relatively moderate effect on ribosomal activity. (Ataluren is designed to cause ribosomes to ignore a premature stop codon during protein translation.)
It's speculation here, but PTC may be reticent to broadcast details of its trial results, owing to the legal troubles it encountered in Gunvalson v. PTC Therapeutics in 2008 and the resultant threat to its clinical-trial program. In this legal case, which was correctly reversed on appeal (in favor of the company), a boy with nmDBMD demanded compassionate access to the drug outside of an ongoing clinical trial.
According to the NIH database, ataluren is currently being studied at the phase 2/3 level in cystic fibrosis and hemophilia A and B (in cases on nonsense mutations). Phase 3 trials in muscular dystrophy are not listed.
* Due to a nonsense (or premature stop codon) mutation, not a more common deletion mutation.
Recently detected DNA fragments of a common pig virus, circovirus type 1 (PCV1), in GSK's Rotarix vaccine have been present since the early development of the vaccine, says the FDA. The agency reported that GSK found the PCV1 DNA fragments in the "working cell bank" and viral "seed" that was used to produce the oral vaccine. Consequently the contaminated Rotarix vaccine was assessed in clinical studies, which were the basis for FDA approval. The detection of PCV1 DNA fragments does not necessarily mean that intact virus was or is present in the vaccine; moreover, the virus itself is not known to cause human disease.
How GSK learned of the presence of PCV1 DNA fragments in Rotarix is somewhat sketchy in detail. According to the FDA, an "independent US academic research team," while assessing a number of vaccines with a "new technology," detected the PCV1 DNA fragments. After finding the DNA fragments in 2 lots of Rotarix vaccine, the researchers alerted GSK on February 9th. Follow-up tests by the company confirmed the presence of the DNA fragments in the 2 tested lots, as well as samples leading back to the seed virus. GSK notified the FDA on March 10th, and the agency, as a precautionary measure, suspended the use of Rotarix yesterday.
The GSK press release provides 2 references on PCV1:
Li L, Kapoor A, Slikas B, et al. Multiple diverse circoviruses infect farm animals and are commonly found in human and chimpanzee feces. J Virol. 2010;84:1674-1682. (From the Blood Systems Research Institute in San Francisco.)
Hatterman K, Roedner C, Schmitt C, Finsterbusch T, Steinfeldt T, Mankertz A. Infection studies on human cell lines with porcine circovirus type 1 and porcine circovirus type 2. Xenotransplantation. 2004;11:284;294. (From the Robert Koch Institut in Berlin.)
Li et al used something called viral metagenomics to identify "circovirus-like" DNA sequences in stool samples of humans and wild chimpanzees. Viral metagenomics is apparently a relative new field, in which researchers attempt to recover viral DNA from environmental samples (as opposed to laboratory cell lines).* In US adults, the detection of circovirus was limited to the discovery of porcine circovirus (which is also found in most US pork products, according to the authors).
Hatterman et al reported on their infection of human cell lines with PCV1, which did not cause "any visible changes," unlike the type 2 PCV strain.
For children who require rotavirus vaccination, the FDA recommends the use of Merck's Rotateq vaccine—which is evidently not contaminated with PCV1 DNA.
* The technique may (may) be the method by which PCV1 DNA fragments were detected in GSK's Rotarix vaccine.
Image of Rotarix administration from Rotarix Prescribing Information.
03/26/10 addendum: Relying on reason and common sense, the European Medicines Agency reported today that it "sees no safety concerns with the Rotarix oral vaccine" and that the DNA of a virus that does not cause human disease "does not present a risk to public health." The EMA stressed that PCV1 is commonly found in meat and other food products.
The agency, however, requested that 1) GSK identify how the DNA fragments got into Rotarix and 2) produce a vaccine that is free of PCV1 DNA. The agency also reported that other GSK vaccines do not contain PCV1 DNA.
As just about everyone knows by now, the Special Masters of the US Court of Federal Claims handed down their decisions on Friday, which deny a causative link between the vaccine preservative thimerosal and autism in 3 test cases.
Among the many opinions rendered in the decisions from the Special Masters (see here, here, and here) are discussions of the autism studies published by Mark and David Geier—whose work has been criticized sharply and at length at this blog and in my 2009 letter to the Journal of the Neurological Sciences.
The court's Special Master George Hastings, for instance, writes in his decision re King v Secretary of Health and Human Services:
[M]ost of the epidemiologic studies that have addressed the thimerosal/autism causation issue have failed to find any association between thimerosal-containing vaccines and autism, but there have been certain exceptions. Those exceptions were studies published by the research team of Dr. Mark Geier and his son David Geier[*]...To be sure, the petitioners in this case have not cited or relied upon those Geier studies in their post-hearing briefs, because, as I will discuss below...the petitioners argue that all of the epidemiologic studies done to date are irrelevant to the petitioners' causation theory in this case. However, since I find that the epidemiologic studies are of relevance, I have found it reasonable to examine those Geier studies, to see if they afford any significant counterweight to the many contrary studies...
After careful consideration, I conclude that the Geiers' studies cannot be given any weight. A number of those studies were considered by the Institute of Medicine (IOM) committee that fully studied the entire thimerosal/autism causation issue in 2004. That committee concluded that the studies were so flawed as to be "uninterpretable," and that the studies contributed nothing meaningful ("noncontributory") concerning the causation issue...The committee noted that the studies were based on databases that themselves had "significant limitations"...and that the studies had "serious methodological problems"...or "serious methodological limitations"...The committee added that the Geiers' articles describing their analytical methods were "not transparent" and omitted "important details," so that it was impossible to evaluate the studies...Other specific deficiencies in the studies were also discussed, including the fact that the Geiers incorrectly used several epidemiologic terms and measures.
In addition, Dr. Fombonne [respondent's expert] agreed with the IOM's criticisms of the Geier studies, and testified that the Geier studies in general failed to use accepted epidemiologic methods...Dr. Rutter [respondent's expert] was critical of the Geier studies as well...Further, petitioners' own expert witness concerning epidemiology, Dr. Greenland, agreed with the criticisms of the Geier articles, acknowledging that those studies are "deficient in methodology"...And none of the expert witnesses for the petitioners vouched for the reliability of the Geier studies.
I have reviewed the published Geier studies discussed in the 2004 IOM report, and I agree with the analysis of those studies set forth in that IOM report. Further, I have reviewed the additional studies published by the Geiers since the 2004 IOM report, and find that those studies suffer from the same type of flaws as the earlier Geier studies. That view includes a study published in 2008 by the Geiers, along with Young as the third author. Two of respondent's experts, Drs. Fombonne and Rutter, testified that that 2008 study was again deeply flawed, and those experts provided a number of specific examples of deficiencies in the study...And, again, none of the petitioners' experts testified in support of that 2008 Young, Geier, and Geier study.
In summary, I conclude that all of the Geier epidemiologic studies are not reliable, and cannot be accorded any weight.
In a lengthy footnote from the decision handed down in the case of Mead v Secretary of HHS, Special Master Patricia Campbell-Smith writes,
Although the studies conducted by Dr. Mark Geier and his son purport to find an association between thimerosal-containing vaccines and autism, their studies have been criticized consistently by various reviewers, including petitioners' own expert epidemiologist, as methodologically deficient...(Dr. Rutter [characterized] the 2008 Young study—that was conducted in part by Dr. Geier and his son...as a poorly designed study for the following reasons: (1) the researchers used a "strange" study design that is both a cohort study [a controlled study] and a time-trend analysis of the available database information [an ecological study] and (2) the researchers included emotional disturbance as one of the neurodevelopmental disorders observed following exposure to thimerosal-containing vaccines even though emotional disorders are not included in any of the official psychiatric classifications systems for neurodevelopmental disorders). The undersigned has reviewed carefully the presented studies conducted by the Geiers and has considered the criticisms leveled against the Geiers' studies. Persuaded that the studies are flawed methodologically in critical respects, the undersigned, without addressing the studies in extensive detail here, declines to accord any evidentiary weight to the studies. The undersigned notes that other researchers have been unable to verify the validity of the Geiers' statistical analysis on a number of occasions and a number of courts have expressed concerns about the reliability of their work.
Campbell-Smith goes on to cite 8 court cases in which the Geiers' work was called, among other things, "unintelligible," or in which Dr. Geier's testimony was described as "not reliable."
In her decision for the third test case, Special Master Denise Vowell affords special attention to the Young, Geier, and Geier study of 2008—which was specifically pulled apart at this blog and by Epi Wonk.
The only studies demonstrating a relationship between TCVs [thimerosal-containing vaccines] and ASD [autism spectrum disorder] are those in which Dr. and Mr. Geier appear as co-authors, including the Young study published in May, 2008, and funded by the OAP PSC [Omnibus Autism Proceeding Petitioners' Steering Committee]...Because petitioners’ own expert commented that the Geier studies were not reliable as evidence... and they were thus not addressed by respondent’s experts, I do not discuss the earlier Geier studies any further. In view of the numerous criticisms of the earlier Geier studies and petitioners' own expert’s dismissal of them, I have placed no reliance on them.
The Young study was an ecological analysis using the VSD database...Doctor Greenland [petitioners' expert] did not comment on this study during his testimony, as the article was introduced after his appearance and excusal. The study found an increased risk of ASD, based on increasing exposure to TCVs. Doctor Fombonne offered several criticisms of this study. In a critique common to many of the studies performed by Dr. and Mr. Geier, Dr. Fombonne commented that the Young article did not provide the data that would allow others to verify the calculations performed.
Doctor Fombonne reproduced one chart from the article...Using the chart, he explained that the birth cohorts used in the study did not all contain the same number of individuals, with most representing 40,000 children...One birth cohort, that of children born in 1990, contains only 2,000 children...When this "outlier" is removed, the purported statistical relationship between ASD and TCVs during the first four years of the sample disappears.
Doctor Fombonne was also highly critical of the authors' addition of invented numbers to the 1995 and 1996 data from the VSD...If the adjustments are removed, there is no correlation at all between the increase in thimerosal exposure and increase in autism cases per 10,000...Doctor Fombonne commented: "It’s dishonest to impute like 45 new cases which are just invented to top up the prevalence in a way which is supportive of their hypothesis. It’s clear that these investigators have a clear track record to do with the data that supports their hypothesis. And I’ve seen that in their previous papers."
Doctor Rutter offered similar criticisms of the Young study...calling it "a poor study for several different reasons"...It began with a cohort design, but ended up being analyzed as a time trend study. That required the authors to make adjustments to the first and last cohorts. Doctor Rutter described this as "putting together chalk and cheese in the hope of gazpacho soup coming out"...The "analytic design and strategy was not a satisfactory one."
He pointed to Table 3 as a striking example of the poor design...Table 3 compares "neurodevelopmental disorders" to several control disorders, measuring the difference in rates of the disorder developing in the cohorts that received 100 micrograms more mercury. The table shows higher rate ratios for autism, ASD, ADD/ADHD, developmental or learning disorders, disturbance of emotions, and tics...Doctor Rutter called this table an example of demonstrating a statistical effect without showing a causal effect...If the neuroinflammation hypothesis is correct, it is difficult to explain how neuroinflammation causes tics or disturbance of emotions. The study reported TCV effects across a very broad range of unconnected disorders having different ages of onset, different genetic factors, and different disease courses...The broad range of effects in these diverse disorders caused Dr. Rutter to be "immediately skeptical as to what [the study] shows."
He also questioned why "disturbance of emotions" was listed in the category of neurodevelopmental disorders, noting that anyone knowledgeable about the field of neurodevelopmental disorders would not have categorized it as one, and would have placed it with the control disorders...To prove their hypothesis that increased mercury exposure causes increases in neurodevelopmental disorders but not control disorders, the authors have to demonstrate that mercury is associated with increased rates of one but not the other. If "disturbance of emotions" was properly placed with the list of control disorders, it would undercut the authors' hypothesis. Their comparison between the two groups is therefore invalid.
Vowell also comments on a reanalysis of the Young et al data by Young herself, who found no association between birth year (which was purported to be associated with exposure to TCVs) and ASD when the imputed cases were removed.
Doctor Young’s subsequently-filed letter indicated that she reanalyzed the data to respond to Dr. Fombonne's criticisms. After she removed the 1990 birth cohort (the one containing only 2,000 cases) and the notional cases for 1995 and 1996, the results for autism, ASD, and unspecified developmental disorders lost statistical significance...She nevertheless defended the use of the 1990 birth cohort and her adjustments to the numbers for 1995 and 1996.
Vowell also dismisses the study of Young et al on the basis of its funding source.
For the reasons indicated in the criticisms proffered by Drs. Fombonne and Rutter, I have accorded the Young study little weight. An additional reason for viewing this study as unreliable is the conflict of interest generated by the PSC’s funding of the study. In its opinion on remand in Daubert, the Ninth Circuit considered whether the matters an expert proposed to testify about flowed from research conducted independently of involvement in the litigation in question, noting that this factor provides objective proof that the research was conducted for scientific purposes.
Yet, despite these unequivocal, disparaging opinions on the work of Geier and Geier, they continue to find sympathetic medical publishers. Their latest article (pdf here) can be found in the Journal of Toxicology and Environmental Health, Part A, which has now published the Geiers' work on 5 occasions.
In their latest article, the Geiers (along with Janet Kern of the Genetic Consultants of Dallas) again try to link the excretion of some urinary porphyrins (their dubious pet marker for mercury toxicity) with ASD severity. The study is very similar to their previously published work in the JNS, and one wonders if there isn't substantial overlap in the study subjects (26 vs 28 children).
Despite the suspicion, the tabulated presentation of the Geiers' urinary porphyrin data in JNS (nanomoles per gram of creatinine) makes it virtually impossible to compare these numbers with their urinary porphyrin values in the latest article (which are presented in "normalized" uP levels). Similar objections can be raised of their graphed data, primarily because of differences in the presentations of the x-axes.
N.B.--The Geier studies reviewed by Special Master Hastings included the following:
