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Mark Geier

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Mark R. Geier, MD, PhD, (b. 1948, Washington, D.C.) is a medical doctor based in Silver Spring, Maryland, who also holds a doctorate in genetics and is board-certified in medical genetics and forensic medicine. He was a researcher at the National Institutes of Health (NIH) for ten years, and previously was a professor at Johns Hopkins University. He has studied vaccines for more than 30 years and has published over 50 peer-reviewed papers on vaccine safety, efficacy, contamination and policy. He has authored over 90 publications and has made several presentations to the Institute of Medicine (IOM) on the adverse effects of vaccinations. He and his son, David Geier, are the only independent researchers ever to have been permitted to study the Vaccine Safety Datalink (VSD) database of the Centers for Disease Control (CDC), (outlined below).

Career

In 1970, while at the National Institutes of Health, Dr. Geier co-authored a paper, published in Nature, reporting the first successful genetic engineering experiment in which bacteriophage Lambda carrying the galactose operon was used to correct the inability of cells in tissue culture from a patient with galactosemia to metabolise the milk sugar galactose. This work received world-wide aclaim in the scientific press and in the news media and resulted in a personal call of congratulation from then President Richard Nixon.

In 1973 Geier was an author of another paper in Nature which reported the spleen, previously thought of as mostly vestigial in humans, in fact played a critical role in immunity by maintaining intact antigen, thus allowing for a more robust immune response which was especially important the vaccination process. Geier was a co-author on a paper in the New England Journal of Medicine which further discussed and extended the observations on the critical role that the spleen plays in response to vaccines and other immune challenges. Also in 1973, after having been part of the group that discovered that there was widespread bacterial virus contamination in US vaccines, Geier presented a paper "A model system for the evaluation of the fate of phage in contaminated vaccines: Physiologic disposition of bacteriophage in mice" at the Proceedings of the Workshop of Problems of Phage Contamination FDA.

In 1978, Geier published a study, "Endotoxins in commercial vaccine", in Applied and Environmental Microbiology, which found high levels of endotoxin in commercial vaccines, especially in whole cell diphtheria, tetanus, pertussis DPT vaccine. Following this paper, Geier worked for many years to help convince the public health authorities to switch from whole cell DTP to the much safer DTaP, which contained a highly purified form of pertussis vaccine.

In 1991, the IOM and the National Academies of Science invited Geier to address them on the toxins contained in DTP vaccine and the expected time frame over which they could be expected to work. Geier presented evidence to the IOM that the expected time of vulnerability was seven days. In 1993, the IOM published that the evidence was compatible with the theory that whole Pertussis vaccine was causing permanent brain damage in otherwise apparently health children, if the first symptoms of neurological damage occurred in the first seven days following the vaccination. The US began to switch to the far safer DTaP in 1993, and as of 2002 the US no longer used any whole cell DTP vaccine.

Geier wrote the article, "The True Story of Pertussis Vaccination: A Sordid Legacy?" which won the first annual Stanley W. Jackson award for the best paper published in the Journal of the History of Medicine and Allied Sciences during the period of 2000 to 2002.

Geier has testified before the US House of Representatives Committee on Government Reform Investigating Vaccines and the Autism Epidemic, to critique the Hviid study, conducted in Denmark on autism and thimerosal exposure, and he has also addressed the Food and Drug Administration (FDA) Advisory Committee regarding vaccine safety. He has testified as an expert witness in about 100 cases before the National Vaccine Injury Compensation Program in the US Court of Federal Claims. Dr. Geier and his son have been invited to speak to many state houses who were or are considering state wide bans on Thimerosal containing vaccines.

Geier has published several scientific reports, with his son David Geier, showing a relation between mercury exposure during infancy and the onset of neurodevelopmental disorders. Geier has suggested his research shows a direct causal link between Thimerosal containing vaccines (TCVs) and the onset of neurological disorders, including autism.

Controversial studies

Geier and his son have published seven studies on the possible link between autistic spectrum disorders and TCVs. In their first study, they compared the number of complaints associated with TCVs, administered between 1992 and 2000, to the number of complaints resulting from a thimerosal-free vaccine administered between 1997 and 2000. The children who received greater amounts of ethylmercury from TCVs were more likely to have a complaint filed with the Vaccine Adverse Event Reporting System (VAERS). Further studies by the Geiers yielded similar results. In 2006, the Geiers published an article , "Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines", which contends that recent data confirms a reduction in autism diagnoses corresponds directly with the removal of TCVs from childhood vaccination schedules.

US health agencies have uniformly rejected the conclusions of the Geiers' studies, and one of the Geiers' articles was the subject of heavy criticism by the American Academy of Pediatrics. [1] Geier says public health officials are "just trying to cover it up." On the other hand, "Mercury in Medicine Taking Unnecessary Risks", a report prepared by the staff of the Subcommittee on Human Rights and Wellness, House Committee on Government Reform, Chaired by Dan Burton, was published in the Congressional Record in May, 2003, stated:

"However, the Committee upon a thorough review of the scientific literature and internal documents from government and industry did find evidence that thimerosal did pose a risk. Thimerosal used as a preservative in vaccines is likely related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding the lack of safety data regarding injected thimerosal and the sharp rise of infant exposure to this known neurotoxin. Our public health agencies’ failure to act is indicative of institutional malfeasance for self-protection and misplaced protectionism of the pharmaceutical industry.".

Limited access to Vaccine Safety Datalink records

The Geiers have been granted access to this data [2], but the National Immunization Program found that "In summary, during the first visit the researchers conducted unapproved analysis on their datasets and on the second visit attempted to carry out unapproved analyses but did not complete this attempt. This analysis, had it been completed, could have increased the risk of a confidentiality breach. Before leaving, the researchers renamed files for removal which were not allowed to be removed. Had it gone undetected, this would have constituted a breach of the rules about confidentiality."[3] Upon further review it was determined by the CDC and the IRBs of the HMOs that there was no violation and the Geiers have again been granted access to the Vaccine Safety Datalink. [citation needed]

Clinical studies on the role of mercury and androgens in autism

In 2003, Geier co-authored a study with Drs. Bradstreet, Kartzinel, and Adams (a professor at Arizona state university), "A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders" in the Journal of American Physicians and Surgeons that examined urinary heavy metal concentrations following therapy for 3 days with meso-2,3-dimercaptosuccinic acid (DMSA), a FDA approved-chelating agent, in 221 children with autism spectrum disorders in comparison to 18 age- and sex-matched controls. Overall, urinary mercury concentrations were about 3-fold significantly higher in children with autistic spectrum disorders than neurotypical controls. Similar urinary cadmium and lead concentrations were observed among children with autism spectrum disorders in comparison to controls. The study concluded that the DMSA treatment described might be useful to diagnose the present burden of mercury in autistic patients.

In 2004 Dr. Geier and his son published a paper in Medical Hypotheses, on the potential importance of lowering testosterone as part of the treatment of autistic spectum disorders, which they claim involve mercury toxicity.

In 2006 the Geiers published a study, "A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders" in Hormone Research. In the Geiers' study, pre-pubertal age children with autism spectrum disorders were assessed for metabolites in the methionine cycle-transsulfuration and androgen pathways, and for present physical development/behaviors indicative of hyperandrogenicity. Significantly increased levels of serum/plasma dehydroepiandrosterone (DHEA) and serum total testosterone relative to the age- and sex-specific normal laboratory reference ranges were observed. Conversely, serum follicle-stimulating hormone (FSH) levels were significantly decreased. Reduced glutathione, plasma cysteine, plasma methionine, serum cystathionine, and serum homocysteine were all significantly decreased. The Geiers' concluded that their results suggest a possible cyclical interaction between the methionine cycle-transsulfuration and androgen pathways in some children with autism spectrum disorders.

The Geiers have continued their research into the relationship between mercury exposure and autistic disorders by clinically helping to identify a unique urinary porphyrin pattern in patients with autism spectrum disorders that is indicative of heavy metal toxicity. Excess urinary porphyrin excretion or porphyrinuria results from inhibition of key enzymatic steps in conditions including genetic deficiencies in heme production enzymes, hepatitis, renal, and erythroid disease, and also by toxic inhibition of heme synthesis enzymes. In both experimental animals and humans exposed to heavy metals, porphyrins are exported at elevated levels into urine. The Geiers' research was conducted following a study by Nataf et al. (Nataf R, Skorupka C, Amet L, Lam A, Springbett A, Lathe R. Porphyrinuria in childhood autistic disorder: implications for environmental toxicity. Toxicol Appl Pharmacol 2006;214:99-108) on a large cohort of French children with autistic disorders that showed a urinary pattern indicative of mercury toxicity. The Geiers research resulted in the first US publication, "A Prospective Assessment of Porphyrins in Autistic Disorders: A Potential Marker for Heavy Metal Exposure" in Neurotoxicity Research that confirmed the observations made in France. The Geiers observed an apparent dose-response effect between autism severity and increased urinary porphyrins. Patients with non-chelated autism (2.25-fold, 83% had levels > 2 standard deviations above the control mean) and non-chelated autism spectrum disorders (2-fold, 58% had levels > 2 standard deviations above the control mean), but not patients with non-chelated pervasive developmental delay not otherwise specified or Asperger's disorder (1.4-fold, 46% had levels > 2 standard deviations above the control mean), had significantly increased median coproporphyrin levels versus controls. A significant increase (1.7-fold) in median coproporphyrin levels was observed among non-chelated autism spectrum disorder patients versus chelated autism spectrum disorder patients. The Geiers' concluded that porphyrins should be routinely clinically measured in autism spectrum disorders, and potential autism spectrum disorder treatments should consider monitoring porphyrin levels.

Mark Geier and David Geier have filed two US patent applications on the use of the drug Lupron in combination with Chelation therapy as a treatment protocol for autism based on the hypothesis that "testosterone mercury" along with low levels of glutathione blocks the conversion of DHEA to DHEA-S and therefore raises androgens which in turn further lowering glutathione levels. This ultimately provides a connection between autism, mercury exposure, and hyperandrogenicity, specifically precocious puberty.

An advocate for vaccine safety

Geier has supported efforts by Representatives Dave Weldon, MD, Dan Burton, and Carolyn Maloney, to pass legislation introduced in early 2005 to ban the use of mercury based preservatives (i.e., thimerosal) in vaccines in the United States. Although mercury preservatives have been removed or reduced from some vaccines in the US, several vaccines and most US influenza vaccines still contain the full dose of Thimerosal. Geier said in an interview that the link between thimerosal and autism was clear.

An NBC crew filmed a presentation by the Geiers before the network's Autism: The Hidden Epidemic?[4] series in February, 2005, but the producers chose not to use the material.

Criticism

Credibility as expert witness questioned

Dr. Geier has been qualified as an expert witness in Federal Court. Specifically, in the United States District Court, Western District of Washington at Seattle in James E. Franics, Plaintiff, v. Maersk Lines, Limited, et al., Defendants (Case No. C03-2898C) the Federal Judge rejected calls for his testimony to be ignored. Additionally, in the United States District Court, Southern District of Ohio at Cincinnati in Eric L. Jeffries, Plaintiff, v. Centre Life Insurance Co., et al. Defendants (Case No. C-1-02-351) the Federal Judge rejected calls for his testimony to be ignored.

Dr Geier has been accepted as an expert witness in approximately 100 hearings for parents seeking compensation from the National Vaccine Injury Compensation Program for vaccine injuries to their children. In ten of these cases, "Dr. Geier's opinion testimony has either been excluded or accorded little or no weight based upon a determination that he was testifying beyond his expertise." (John and Jane Doe v. Ortho-Clinical Diagnostics, Inc., 2006). Chief Judge Archer of the United States Court of Appeals for the Federal Circuit ruled in James McClendon and Elizabeth M. McClendon, as next friends of Kristen McClendon, a minor, Petitioners-Appelles, v. Secretary of the Department of Health and Human Services, Respondent-Appellant (93-5106) that, "The court then analyzed the reasons why the special master also rejected the McClendons' expert, Dr. Geier, and concluded that it was primarily because he was not a neurologist. The court determined that this was not a reasonable basis to disregard completely Dr. Geier's probative testimony. The court therefore held that the special master's decision was arbitrary and capricious."

Dr. Geier's views have been found to fall outside of the scientific consensus. In a 2006 case (John and Jane Doe v. Ortho-Clinical Diagnostics, Inc.) regarding an immunoglobulin containing thimerosal which was alleged to have caused autism, Dr. Geier's testimony was found to fall below the Daubert standard, which essentially requires expert testimony on science to be scientifically sound and represent the general consensus. As Dr. Geier provided most of the plaintiffs' evidence, the case was thus subject to summary judgement.

Amongst the Judge's decision's criticisms, Dr. Geier's literature review was found to be insufficient in justifying his claims, his lack of qualification in pediatrics was highlighted and he was found to be a "professional witness in areas for which he has no training, expertise, and experience", whose testimony was "intellectually dishonest", "nothing more than an egregious example of blatant, result-oriented testimony."

Allegations of ethics violations

On March 16, 2006, the U.S. Patent and Trademark Office published two patent applications by Mark Geier and David Geier on the use of the drug Lupron in combination with Chelation therapy as a treatment protocol for autism [5]. Lupron is a hormone agonist with significant side-effects [6][7] which has been used as a chemical castration agent [8]. Kathleen Seidel, an autism rights (neurodiversity) activist who manages the Neurodiversity.com blog, set out to scrutinize research by Geier & Geier that supports their "Lupron protocol".

On June 9, 2006, Seidel documented how she uncovered an apparent affiliation misrepresentation in the part of David Geier [9]. In an article that had been published ahead of print in the journal Hormone Research, and which had already been indexed by PubMed, David Geier’s institutional affiliation was listed as "Department of Biochemistry, George Washington University, Washington, D.C." However, according to Dr. Allen Goldstein, Chairman of the GWU Department of Biochemistry and Molecular Biology, Mr. Geier took two courses in biochemistry during the 2003-2004 school year and none thereafter, and he took the last of three public health courses during the Spring 2005 semester. Dr. Goldstein described the affiliation claim in the Hormone Research article as “fallacious,” and stated that it conveyed a “significant misrepresentation” of Mr. Geier’s position in the field of biochemistry.

On July 5, 2006, the journal Hormone Research republished the article with a byline that read "President, MedCon, Inc., 14 Redgate Ct., Silver Spring, MD 20905, USA, Tel. +1 301 384 6988." [10] Mark Geier claims the editors of Hormone Research had inadvertently made the mistake and subsequently corrected it.

The republished article contains a "Potential Conflict of Interest and Affiliation Statement" that did not appear in the original version:

"Dr. Mark Geier is not affiliated with MedCon, Inc. David Geier is the President of MedCon. MedCon does not have a financial interest in relation to autism and puberty. Neither Dr. Mark Geier nor David Geier has any conflict of interest regarding anything related to this paper."

On June 20, 2006, Seidel made a second damaging revelation [11]. She had requested a copy of the electronic registration of the Institutional Review Board (IRB) that approved the study initially accepted by Hormone Research. An IRB is typically an impartial body which determines whether research is scientifically valid, ethical, and in accordance with relevant regulations.

The members of the Geiers' IRB included Mark Geier and David Geier themselves, Ann Geier (who is Mark Geier's wife), two anti-thimerosal activists, a DAN! practitioner who prescribes Lupron injections, and an anti-thimerosal lawyer. Given the composition of the IRB, and considering Federal and state regulations, Seidel contends that it is unlikely that a majority of voters eligible to decide on Geier & Geier's research could ever be achieved.

Kathleen Seidel has made additional allegations regarding an apparent shift of terms from "precocious puberty" to "hyperandrogenicity" [12], and possible misrepresentation of cited work [13].

Allegations of plagiarism

On August 10, 2006, Kathleen Seidel released documentation on similarities between an early draft of a paper published in 2003, Versteren et al. (2000), and Geier & Geier (2005) [14]. Examples of similarities discovered follow.

  • From Verstraeten et al. (2000), p. 2-3: "The project links medical event information, vaccine history, and selected demographic information from the computerized clinical databases of four staff model health maintenance organizations (HMO)s: Group Health Cooperative of Puget Sound (GHC) in Seattle, Washington; Kaiser Permanente Northwest (NWK) in Portland, Oregon; Kaiser Permanente Medical Care Program of Northern California (NCK) in Oakland, California; and Southern California Kaiser Permanent (SCK) in Los Angeles, California. HMO members have unique HMO identification numbers that can be used to link data on their medical services within the HMO. Vaccination data are derived from computerized immunization tracking systems that are maintained by each of the HMOs."
From Geier & Geier (2005), p. CR163: "The project links medical event information, vaccine history, and selected demographic information from the computerized clinical databases of four health maintenance organizations (HMO)s: Group Health Cooperative of Puget Sound (GHC) in Seattle, Washington; Kaiser Permanente Northwest (NWK) in Portland Oregon; Kaiser Permanente Medical Care Program of Northern California (NCK) in Oakland, California; and Southern California Kaiser Permanente (SCK) in Los Angeles, California. HMO members have unique HMO identification numbers that can be used to link data on their medical services within the HMO. Vaccination data are derived from computerized immunization tracking systems, maintained by each of the HMOs."
  • From Verstraeten et al. (2000), p. 3: "We have restricted our cohort to children born between 1992 and 1997 into one of the two HMOs with the most complete automated outpatient data set (GHC and NCK). For these two HMOs we have follow-up data to the end of 1998. Children in the cohort thus have a follow-up time of 1 to 7 years."
From Geier & Geier (2005), p. CR163: "In the present study, as independent researchers, we analyzed data from a cohort of children born between 1992 and 1997 into one of the two HMOs with the most complete automated outpatient data sets (GHC and NCK). For these two HMOs, follow-up data to the end of 1998 was analyzed. Children in the cohort, thus, have a follow-up time of 1 to 7 years."
  • From Verstraeten et al. (2000), p. 3: "We calculated the cumulative exposure to ethylmercury from individual automated vaccination records, assuming each vaccine to contain the mean dose reported by manufacturers to the FDA. We assessed this cumulative exposure at the end of the first, second, third and sixth months of life. The Thimerosal content of childhood vaccines used in the two HMOs is as follows:"
From Geier & Geier (2005), p. CR163: "The cumulative exposure to ethylmercury from individual automated vaccination records were calculated, assuming each vaccine to contain the mean dose reported by manufacturers to the Food and Drug Administration (FDA). This cumulative exposure was assessed at the end of the first, second, third, and sixth months of life. The thimerosal content of childhood vaccines used in the two HMOs is as follows:"
  • From Verstraeten et al. (2000), p. 5: "We used a Cox proportional hazard model to compare risk of developing any of the outcomes among different levels of exposure. By stratifying on HMO, year and month of birth, we compared children born within the same month at the same HMO. We adjusted the models for gender only. By using age of the child as the time variable in the PH model we also ensured comparison of children of equal age."
From Geier & Geier (2005), p. CR163: "A Cox proportional hazard model was used to compare the risk of developing any of the outcomes among different levels of exposure. By stratifying on HMO, year and month of birth, children were compared that were born within the same month at the same HMO. The data were adjusted in the models for gender only. By using the age of the child as the time variable in the proportion hazard model, it was possible to ensure comparison of children of equal age."
  • From Verstraeten et al. (2000), p. 7-8: "Table 2 shows the number of cases encountered for each disorder, the mean age at first diagnosis, the distribution over the two HMOs and the percentage males among cases."
From Geier & Geier (2005), p. CR164: "Table 5 shows the number of cases encountered for each disorder, the mean age at first diagnosis, the distribution over the two HMOs, and the percentage males among cases."
  • From Verstraeten et al. (2000), p. 12: "Limitations: Some misclassification errors may have occurred in the assessment of the inclusion/exclusion criteria: some HepB Ig administrations may be missed, some premature children may not be classified as such. In case of a true effect of thimerosal, this error is likely to cause a bias towards the null hypothesis."
From Geier & Geier (2005), p. CR166: "In considering the results from the VSD database, there may have been some limitations. Some misclassification errors may have occurred in the assessment of the inclusion/exclusion criteria: some hepatitis B immunoglobulin administrations may have been missed and some premature children may not have been classified as such."

On August 8, 2005, Dr. Frank DeStefano of the CDC wrote a letter to the Editor-In-Chief of the journal Medical Science Monitor regarding the similarities between Geier & Geier (2005) and the 2000 draft of the Verstraeten et al. study published in 2003 [15]. Dr. DeStefano, who is one of the co-authors of the study, stated that he had doubts that the Geiers actually performed the Phase II analyses because, to the best of his knowledge, the Geiers had not had access to the VSD data required to perform those analyses. Medical Science Monitor acknowledged receipt of the letter on August 17, 2005, but it is not clear whether the editorial board of the journal ever addressed the concerns raised by Dr. DeStefano.

See also

References

  • JPandS.org (pdf) - 'Thimerosal in Childhood Vaccines, Neurodevelopment Disorders and Heart Disease in the United States', Mark and David Geier, Journal of American Physicians and Surgeons, vol 8, no 1, Spring, 2003
  • JPandS.org (pdf) - 'A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders', Jeff Bradstreet, MD, David A. Geier, BA, Jerold J. Kartzinel, MD, James B. Adams, PhD, Mark R. Geier, MD, PhD Journal of American Physicians and Surgeons, vol 8, no 3, Summer, 2003
  • MedSciMonit.com (pdf) - 'A two-phased population epidemiological study of the safety of thimerosal-containing vaccines: a follow up analysis', David A. Geier and Mark R. Geier, Med Sci Monit, vol 11, no 4, April 1, 2005
  • A-Champ.org (pdf) - 'Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines', David A. Geier, BA, and Mark R. Geier, MD, PhD, Journal of American Physicians and Surgeons, vol 11, no 1, Spring, 2006

External links

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