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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).

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 vestigual 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 especailly 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. 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."[1].

Limited access to Vaccine Safety Datalink records

On February 17, 2004, a panel of medical experts was assembled by the Institute of Medicine (IOM), an arm of the National Academy of Sciences. The panel recommended the CDC ease its restrictions on outside scientists seeking access to its strictly confidential Vaccine Safety Datalink, containing over seven million records including reports of suspected adverse reactions to vaccines.

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]

Clinical studies on the role of mercury and androgens in autism

Geier has also published studies which, he says, 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 2004 Dr. Geier and his son published a paper in Medical Hypotheses, a non-peer-reviewed journal, 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 in the peer-reviewed "Hormone Research", "A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders." This paper presented data from Geier's clinic suggesting a cyclical interaction between the methionine cycle-transsulfuration and androgen pathways in children with autistic disorders. But this paper was subsequently withdrawn by Hormone Research amid allegations of affiliation misrepresentation [4].

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?[5] series in February, 2005, but the producers chose not to use the material.

Credibility as expert witness questioned

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.


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 published a signed ruling stating:


"This matter comes before the Court on the Defendant United States of America’s Motion to Exclude Testimony and Report of Plaintiff’s Expert, Dr. Mark Geier (Dkt. Nos. 176 and 177). Having reviewed the materials submitted by the parties and determined that oral argument is not necessary, the motion is DENIED for the reasons set forth below.

I. BACKGROUND Plaintiff filed suit against Maersk Lines, Ltd. and the United States for injuries he sustained allegedly as a result of being forced to take the vaccine for anthrax (“AVA”). Plaintiff’s expert, Dr. Mark Geier, is prepared to give testimony on the following opinions he holds regarding this case: (1) that it was contrary to proper medical practice for Plaintiff to be coerced into being given AVA and that Plaintiff was not provided with sufficient information or warning of the risks of the vaccine; (2) that AVA can cause autoimmune disorders such as Guillain-Barre Syndrome (“GBS”), which is what Plaintiff has been diagnosed with after taking the vaccine; and (3) the vaccine was not reasonably fit for its intended purpose. (Geier Decl. ¶ 29; Pl.’s Resp. n.1.) The government filed this motion asking the Court to exclude Dr. Geier’s testimony on two grounds. The government first argues that Dr. Geier is not qualified to testify as an expert as to whether AVA can cause GBS. (Def.’s Mem. in Supp. of Mot. 2–7.) The government also challenges Dr. Geier’s expert testimony under Daubert, arguing that his causation opinion does not rest on a reliable foundation. (Id. at 7–15.)

II. ANALYSIS

A. Dr. Geier’s Qualifications The government first asserts that Dr. Geier’s expert testimony should be excluded on the grounds that he is not qualified because he was educated and practices in the field of genetics. (Def.’s Mem. 3–4.) However, simply because a witness does not have a formal degree in the field does not disqualify him or her as an expert. See, e.g., Hangarter v. Provident Life & Accident Ins. Co., 373 F.3d 998, 1016 (9th Cir. 2004) (witness qualified as expert based on significant knowledge of and experience in the industry). The issue of an expert witness’s qualifications “is governed by Federal Rule of Evidence 702 which contemplates a broad conception of expert qualifications.” Thomas v. Newton Int’l Enter., 42 F.3d 1266, 1270 (9th Cir. 1994). Rule 702 states that an expert may be qualified by “knowledge, skill, experience, training, or education.” FED. R. EVID. 702. While Dr. Geier’s formal degrees are in genetics, he has extensive experience with and knowledge of vaccines. Dr. Geier has worked in the area of vaccines for over thirty years (Geier Rep’t 1), has published many articles relating to vaccines and their safety (Geier Rep’t 2–3), has published two articles on AVA specifically (Geier Decl. ¶ 18), and has testified before Congress on matters relating to vaccination safety (Geier Rep. 3). Given Dr. Geier’s significant knowledge of and experience with vaccines, he is qualified to testify as an expert on the issue of whether AVA caused Plaintiff’s condition. See Hangarter, 373 F.3d at 1016 (witness with significant knowledge and experience in relevant industry qualified to testify as expert).

B. Reliability of Dr. Geier’s Opinion Upon objection, the Court must make a reliability determination of the witness’s testimony to fulfill its gatekeeping function under Daubert. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993); Elsayed Mukhtar v. Cal. State Univ., Hayward, 299 F.3d 1053, 1066 (9th Cir. 2002). The focus of the reliability determination is on the principles and methodology used by the witness, not on the conclusions they generate. Daubert, 509 U.S. at 595. The reliability of expert testimony is to be judged by the following, non-exhaustive, factors: (1) whether a theory or technique can or has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether the theory or technique has a known or potential rate of error and whether standards exist for controlling that risk of error; and (4) whether the theory or technique is generally accepted in the relevant scholarly or professional community. See Daubert, 509 U.S. at 592–95.2 The Government argues that Dr. Geier’s opinion that AVA can cause GBS is not reliable. Dr. Geier bases his causation opinion on his review of peer-reviewed medical and scientific literature, including a book by the Institute of Medicine on adverse events caused by vaccines, two articles Dr. Geier co-authored on adverse reactions to AVA, and several other articles on the topic of adverse events as a result of vaccination. (Geier Decl. ¶¶ 18 and 32.) Contrary to the government’s position, the existence of a report with conclusions contrary to those of the expert witness does not suffice to hold the witness’s testimony unreliable. See Kennedy v. Collagen Corp., 161 F.3d 1226, 1230–31 (9th Cir. 1998) (opposing opinions and evidence go to the weight afforded an expert’s opinion, not to admissibility). In addition, simply because the studies Dr. Geier relies on do not specifically conclude that AVA can cause GBS does not render his opinion inadmissible. See id. at 1230 (lack of conclusively established cause effect relationhip between drug and disorder does not render causation opinion of expert inadmissible).

Therefore, the Court finds Dr. Geier’s theory on general causation in this case has been subjected to sufficient peer review and publication to render it reliable. Furthermore, reliance on the VAERS database to ascertain the risks associated with a given vaccine is generally accepted in the scientific community. Dr. Geier has published an article explaining this database and its use to evaluate vaccine safety concerns. (Geier Decl. ¶ 16.) In addition, Dr. Geier’s articles using the VAERS database to ascertain the relative risks of vaccines have been accepted by peerreviewed scientific and medical journals. (Id. at ¶ 36.) Also, this method has been used by other researchers, including those at the Center for Disease Control. (Id.) Just as in Kennedy, the reasoning behind Dr. Geier’s general causation opinion is based on objective, verifiable evidence and scientific methodology. Kennedy, 161 F.3d at 1229–30 (use of peer-reviewed publications and clinical studies to form general causation opinion generally accepted). Therefore, Dr. Geier’s methods used to form his causation opinion are generally accepted in the scientific community.

In sum, the Court finds that Dr. Geier’s opinion on general causation incorporates the indicia of reliability set forth by Daubert, 509 U.S. at 592–95. Therefore, the Court finds Dr. Geier’s causation opinion to be reliable. As a result, any flaws that might exist go to the weight afforded his opinion, not its admissibility. In re PPA Prods. Liab. Litig., 289 F. Supp. 2d 1230, 1240 (W.D. Wash. 2003) (citing Kennedy 161 F.3d at 1230–31).

III. CONCLUSION In accordance with the foregoing, the United States’ motion is DENIED. Dr. Geier’s testimony shall not be excluded.

SO ORDERED this 8th day of December, 2005. UNITED STATES DISTRICT JUDGE"


Additionally, in the United States District Court, Southern District of Ohio, Western Division at Cincinnati in Eric L. Jefries, Plaintiff, v. Centre Life Insurance Co., et al., Defendants the Federal Judge Sandra S. Beckwith determined:

"But what I'd like to do is start with oral rulings on the assorted Daubert motions and then move on to the motions for summary judgement. Whatever else I may say on the subject of the Daubert motions, obviously the analysis is rooted in Rule 702 of the Rules of Evidence, and the touchstone for the Court's decisions on these motions is whether or not the testimony will assist the trier of fact to understand the evidence or determine a fact in issue.

So, let's start with Dr. Geier. Dr Geier's opinion is based on more than the VAERS database...According to Dr. Geier, he relied on the following combination of factor which leads him to the conclusion that plaintiff had an adverse reaction to the Hepatitis B vaccine: medical plausibility; studies in peer-reviewed literature documenting a connection between Hepatitis B vaccine and adverse reactions; case studies reporting similar reactions; Plaintiff's reaction occurred in an acceptiable time period following the vaccination; all of this in conjunction with the VAERS database association.

In addition, Dr. Geier trestified at the hearing that the Hepatitis B vaccine contains mercury and aluminum compounds, and that these substances in vaccines have been shown to cause cognitive defects. The combination of factors provides a reasonably reliable basis for Dr. Geier to conclude that Plaintiff's cognitive impairments were caused by an adverse reaction to the Hepatitis B vaccine, and that opinion is, of course, relevant to the issues in this case.

Therefore, the motion to exclude Dr. Geier's testimony is not well-taken and is denied. His opinion could be helpful to the jury."

Geier has been criticized over his qualifications in these hearings, wherein one Special Master labeled him "a professional witness" who "clearly lacks the expertise" required. [6] Critics of the vaccine injury compensation system question the stringency of the requirements, which they contend effectively preclude fair presentation in the hearings of testimony from their experts.

On at least ten separate occasions, the Special Master ruled that Geier lacked the necessary qualifications or board-certification to offer an expert opinion. Litigants pressing vaccine injury claims have a dual challenge, since relatively few experts in relevant fields think thimerosal causes autism, and even fewer work in specialties required by the Vaccine Injury Compensation Program. He was also found wanting during previous testimony over DTP, such as in the 1987 Graham Case, overturned by the court of appeals in 1990 due to serious numerical error by Dr Geier [7].

However, on November 25, 2003, Special Master French praised Geier’s credentials and vast experience and said Dr. Geier "ranks high among those who have studied vaccine issues through the medical literature on vaccines, databases, studies, articles and information on vaccine safety and efficacy in vaccine policy. The tenor of his testimony in this case addressed the importance of statistical databases in providing statistical reliability and validity in interpreting the epidemiology and issues relating to autism and various vaccines...Dr. Geier has recently proposed a data-sharing process that would improve the reliability of present statistical data that would include the present VAERS statistical database. It would be helpful in interpreting the epidemiology and issues relating to the autism controversy." [8]


Furthermore, Dr. Geier's testimony has been found to be relevant and credible, and resulted in petitioner's prevailing before the National Vaccine Injury Compensation Program in decisions reached in each of the following cases:

Alger v HHS - Special Master Baird

Allen v HHS - Special Master Hauptly

Bailey v HHS - Special Master Gerard

Batdorf v HHS - Special Master Bernstein

Caouette v HHS - Chief Special Master Golkiewicz

Ciotoli v HHS - Special Master Wright

Cline v HHS - Special Master Bernstein

Davis v HHS - Special Master Wright

Dileo v HHS - US Federal Court of Claims Judge Margolis

Essex v HHS - Special Master Wright

Estep v HHS - US Federal Court of Claims Judge Margolis

Estep v HHS - Special Master Baird

Freeman v HHS - Chief Special Master Golkiewicz

Gonzales v HHS - Special Master Abell

Gowan v HHS - Special Master French

Grant v HHS - Chief Special Master Golkiewicz

Grant v HHS - US Federal Court of Claims Judge Tidwell

Hailey v HHS - Special Master French

Ionescu v HHS - Special Master Hastings

Lambert v HHS - Special Master Wright

McClendon v HHS - US Federal Court of Claims, Chief Judge Archer

McClendon v HHS - US Federal Court of Claims Judge Gibson

McDermott v HHS - Special Master Hastings

Misenko v HHS - Special Master Millman

Monteverdi v HHS - Special Master Gerard

Newton v HHS - Special Master Gerard

Oetting v HHS - Special Master French

Overgard v HHS - Special Master French

Pollard v HHS - Special Master Bernstein

Pusateri v HHS - Special Master French

Raines v HHS - Special Master Hauptly

Richardson v HHS - US Federal Court of Claims Judge Andewelt

Richardson v HHS - Special Master French

Riggs v HHS - Special Master French

Sanders v HHS - Special Master Wright

Seman v HHS - Special Master Baird

Siegfried v HHS - Special Master Baird

Sumrall v HHS - US Federal Court of Claims Judge Turner

Sumrall v HHS - Special Master French

Tafoya v HHS - Chief Special Master Golkiewicz

Thomas v HHS - Special Master French

Waugh v HHS - Special Master Wright

Wolf v HHS - Special Master French

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 [9]. Lupron is a hormone agonist with significant side-effects [10][11] which has been used as a chemical castration agent [12]. Kathleen Seidel, an autism rights activist who runs 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 [13]. 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.

After the editors of Hormone Research had learned of the erroneous affiliation, the article was removed from the electronic version of the journal, and it also disappeared from PubMed.

On June 20, 2006, Seidel made a second damaging revelation [14]. She had requested a copy of the electronic registration of the Institutional Review Board (IRB) that approved the study initially accepted by Hormone Research. The members of the 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.

Background

Education:

Work Experience:

Board Certification:

Other Positions:

  • 1980-2003 - Laboratory Director, Molecular Medicine, MD
  • 1980-Present - Co-director of Genetic Consultants, Bethesda, MD
  • 1981-Present - Director of Institute of Immuno-Oncology and Genetics, MD
  • 1986-Present - President of Genetic Counseling and Research, Inc., T/A The Genetic Center, Baltimore, MD
  • 1997-Present - President of Genetic Counseling and Research, Inc. T/A The Ultrasound Institute of Baltimore
  • 1997-Present - President of the Genetic Centers of America
  • 2001 - Host of one hour weekly medical talk show “The Dr. Mark Geier Show” on KFNX in Phoenix, Arizona, WALE in Provident, Rhode Island, and on the World Wide Web.

Journal Peer-Reviewer:

  • Annals of Internal Medicine
  • Clinical and Experimental Rheumatology
  • Environmental Health Perspectives
  • Expert Review of Vaccines
  • Expert Opinion on Emerging Drugs
  • Vaccine

Major Presentations:

  • Addressed United States’ State Department, Foreign Service Institute (Washington, DC) on Contemporary Genetics
  • Addressed the Institute of Medicine of the U.S. National Academy of Sciences (Washington, DC) on Vaccine Safety & Vaccine Policy Issues
  • Addressed the Government Reform Committee of the United States’ House of Representatives (Washington, DC) on Vaccine Safety Issues
  • Addressed the Food and Drug Administration’s Vaccine Advisory Committee (Silver Spring, MD) on Vaccine Safety Issues

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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