Mark Geier

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, have been permitted to study the Vaccine Safety Datalink (VSD) database of the Centers for Disease Control (CDC), (outlined below), in their capacity as witnesses for plaintiffs in litigation.

He is the subject of much criticism, including his credibility as an expert witness, and allegations of ethics violations and plagiarism. In January 2007, a paper by the Geiers was retracted by the journal Autoimmunity Reviews.

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 acclaim 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 the 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 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, suggesting a relation between mercury exposure during infancy and the onset of neurodevelopmental disorders. He has claimed that 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 the 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.

U.S. 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. 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 and chaired by Dan Burton, 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 the Vaccine Safety Datalink records, but the National Immunization Program found that "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." 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.

Clinical studies on the role of mercury and androgens in autism
Geier has also published studies which indicate children diagnosed with autism excrete more mercury upon chelation than control subjects. Many of these children are reported as having tests showing amounts of mercury excreted several times the normal levels. Chelation therapy is conventionally used only to treat heavy metal poisoning, and carries the risk of overly reducing the levels of beneficial metals in the body, such as calcium. In 2006, the Geiers published in Hormone Research data suggesting a cyclical interaction between the methionine cycle-transsulfuration and androgen pathways in children with autistic disorders.

Mark Geier and David Geier have filed two U.S. 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 lower glutathione levels. The thought is that 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? series in February, 2005, but the producers chose not to use the material.

Expert witness testimony
Dr. Geier has been qualified as an expert witness in Federal Court and has been accepted as an expert witness in approximately 100 hearings for parents seeking compensation from the National Vaccine Injury Compensation Program for alleged vaccine injuries to their children. However, 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."

Dr. Geier's views have been found to fall outside of the scientific consensus. In a 2006 case 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 judgment.

Amongst the criticisms in the judge's decisions, 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."

Ethics
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. Lupron is a hormone agonist, approved for treatment of "precocious puberty", a condition in which children exhibit premature signs of puberty. According to the Mayo Clinic, treatment for precocious purberty may include GnRH analogue therapy, involving injections of Leuproprelin, a GnRH agonist.

Kathleen Seidel, parent of an autistic child as well as the author of a book on entertaining as a Sufi Islamic, has been an active critic of the Geiers. Ms. Seidel, on her blog, neurodiversity.com, has documented an apparent affiliation misrepresentation in the part of David Geier. In an article that had been published online in May of 2006 ahead of print in the journal Hormone Research and indexed by the PubMed database, David Geier’s institutional affiliation was listed as "Department of Biochemistry, George Washington University, Washington, D.C." However, according to Dr. Allen Goldstein, who is the chairman of the GWU Department of Biochemistry and Molecular Biology, Mr. Geier took only 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 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." Mark Geier claims that 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."

Further, an investigation of the registration of the Institutional Review Board (IRB) that approved the study initially accepted by Hormone Research found that the members of the Institute for Chronic Illnesses IRB committee included Mark Geier and David Geier themselves, Ann Geier (Mark Geier's wife), two anti-thimerosal activists, a DAN! (Defeat Autism Now!) practitioner who prescribes Lupron injections, and an anti-thimerosal lawyer. . An IRB is typically an impartial body which determines whether research is scientifically valid, ethical, and in accordance with relevant regulations; given the composition of the IRB, and considering Federal and state regulations, the objectivity of the IRB committee approving the Geiers' research is contended.

There have been additional allegations regarding an apparent shift of terms from "precocious puberty" to "hyperandrogenicity," and possible misrepresentation of cited work.

Allegations of plagiarism
On August 10, 2006, Kathleen Seidel released documentation on similarities between an early draft of a paper published by Versteren et al. in 2000, and one published by Geier and Geier in 2005. 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 2000. 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.

Notes and 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
 * Plagiarism Definition of Plagiarism