Geier Suspension Upheld · 256 days ago

Following a lengthy appeals process, on March 22, 2012, the Maryland Board of Physicians upheld the suspension of Dr. Mark Geier’s license to practice medicine. The decision follows that of the Maryland Office of Administrative Hearings, which ruled in September 2011 that the Board had “proved by a preponderance of the evidence that summary suspension of [Dr. Geier’s] license to practice medicine is imperatively required to protect the public health, safety or welfare”; and a Cease and Desist Order issued by the Board on January 25, 2012, and amended on February 22, following the discovery that Dr. Geier had continued to prescribe and authorize refills of medication after the suspension of his license.

From the Administrative Law Judge’s decision

Page 16: “[Dr. Geier’s] Evaluation of each of the Patients was deficient because it did not include either a complete physical examination of the Patient performed by [him] or a review by [him] of a recent complete physical examination record of the Patient provided to him by the Patients’ other medical providers.”

“None of the summaries of the information [Dr. Geier] received during his intake history from the Patients’ parents, or the summaries of the information [he] personally obtained from his examination of the Patients that are contained in the Records, or the prior medical records that may have been submitted to [him] and are contained in the Records, contain the results of a recent complete physical examination of the Patients, a complete medical history of the Patients with a review of all the relevant physical systems, an evaluation of the Patients’ heart or lungs, results of a recent physical examination of the Patients’ abdomens, or a Tanner Stage level of the Patients.

Page 18: “[Dr. Geier’s] evaluation of each of the Patients was deficient because it did not include a specific detailed identification of the presenting symptoms he was targeting for future treatment.”

Page 21: “[Dr. Geier’s] Evaluation of each of the Patients was deficient because he did not obtain sufficient information from the Patients to be able to accurately interpret the results of the lab tests he ordered for those Evaluations.”

Page 22: “[Dr. Geier’s] initial and continuing Evaluations of the Patients were deficient because his explanations and documentation of treatment plans were incomplete, because he failed to explain why medications were being added, modified, or deleted, and because he failed to include a rationale as to why specific therapies were chosen over others.”

Page 28: “[Dr. Geier] monitored the Patients’ response to his therapies only through the Parents’ brief, mostly vague reports and through the results of laboratory testing he could not accurately interpret. [His] monitoring plan for each Patient was inadequate to carefully monitor the Patient for response to treatment and to protect that Patient from adverse side effects. [His] monitoring plan was an insufficient platform upon which to make safe modifications of therapies.”

Page 32: “[Dr. Geier] prescribed chelation therapy for Patients […] without appropriate rest breaks to permit their bodies to recover from the stresses of chelation and thereby placed these Patients at risk of serious harm.”

Pages 38-39: “The missing components of [Dr. Geier’s] Evaluations and monitoring plans prevented [him] from being able to accurately assess whether Patients needed the therapies and treatment he prescribed for them, and from being able to accurately assess the risks and benefits to each Patient of each of those prescribed therapies and treatment. His monitoring plans for Patients lacked critically important information necessary to assess whether the Patients could be or were suffering adverse side effets from the treatments and therapies he prescribed. The missing components and deficiencies in [his] initial Evaluation and ongoing monitoring of Patients posed a risk of serious harm to each of these Patients. The missing components and deficiencies in [his] initial Evaluations and his inadequate monitoring of the Patients make it substantially likely that [his] evaluation and monitoring of other patients would be similarly defective and present a substantial likelihood of risk of serious harm to the health, safety, or welfare of the public.”

Pages 60-61: “The Records contain hundreds of pages of results from laboratory testing that the Patients endured on a monthly or more frequent basis. [Dr. Geier] testified in his sworn statement that he initiatied and modified the administration of Lupron and initiated and continued or discontinued chelation therapy based in large part upon the results of these tests. Yet, the Records contain no consistent documentation as to whether [he] reviewed those monthly lab test results or how his ongoing treatment reflected their results.”

Pages 62-63: “[I]nconsistencies between the [Dr. Geier’s] sworn statement and the Records he maintained of the Patients, the lack of information in the Records about treatment decisions and what led to those treatment decisions, the absence of evidence that [Dr. Geier] made decisions based on his own hands-on complete physical examination and/or receipt of complete medical histories, the lack of evidence that [Dr. Geier] was relying on fully-informed, objective reports of the Patients’ conditions, and the infrequency of in-person visits with many of the Patients are factors which establish that the Patients were at risk of serious harm: from a constricted information base, from a deficient basis for initiating treatment, and from a flawed system of monitoring adverse side effects and efficacy. I believe that these factual considerations imperatively require emergency action.

“I conclude that for all these reasons, the Patients’ health, safety or welfare was at risk of serious harm. Further, the existence of all these problems throughout all the Records raises a substantial likelihood that the risk of serious harm to the Patients was also posed to many other children with autism treated by [Dr. Geier]. I find that this meets the necessary standard for summary suspension of [Dr. Geier’s] license: allowing him to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety or welfare.”

The Board agreed. From page 9 of its Final Decision and Order:

“For Dr. Geier to practice medicine at this time would constitute a danger to the patient community”

— a community consisting of children and young adults with autism at risk of maltreatment by profiteering ideologues and loving but misguided parents led to believe their scientifically unsupportable claims.

Both the Administrative Law Judge’s decision and the Board’s Final Decision and Order are contained in the document posted to the Board website.

Maryland Authorities Charge "Lupron Protocol" Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine · 592 days ago

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

Dr. Geier and Mr. Geier have promoted themselves as “experts” in the treatment of autism since 2004, shortly after Dr. Geier agreed to serve as an expert witness for petitioners in the Omnibus Autism Proceeding, and shortly after David Geier was awarded a Bachelor’s degree in Biology from the University of Maryland, Baltimore County. Although Dr. Geier’s practice was originally limited to obstetrics and genetic counseling in his home state of Maryland and neighboring Virginia, since 2008, he and his unlicensed son have sought to establish a nationwide presence, founding a chain of ASD Centers” with offices in Florida, Indiana, Kentucky, New Jersey, Texas, Washington, and Illinois. In their efforts to attract new patients, they have frequently touted the availability of insurance coverage for medication regimens that they nonetheless acknowledge are experimental and of unproven efficacy.

In its statement of charges against Dr. Geier, the Maryland Board of Physicians contends that his treatment of patients:

“constitutes in whole or in part unprofessional conduct in the practice of medicine; willfully making a false report or record in the practice of medicine; practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine; grossly overutilizing health care services; failing to meet the standard of quality care; and failing to maintain adequate medical records.”

Allegations of general deficiencies in Dr. Geier’s practice include:

Additionally, Dr. Geier was charged with wilful failure to file legally required medical reports, due to his failure to provide, after a subpoena and several follow-up requests from the Board, a copy of complete medical records for a patient identified only as “JQ4MP-52” on a laboratory form.

The text of the charges against Dr. Geier is substantially similar to the text of the summary suspension order issued on April 27, 2011. Charges against David Geier are outlined in a separate document, reproduced below in its entirety.

A Case Resolution Conference to address charges against both of the accused has been scheduled for Wednesday, July 6, 2011, at 10:00 a.m. at the Board’s offices in Baltimore.


In the matter of David A. Geier before the Maryland State Board of Physicians
License Number: (unlicensed)
Case Numbers 2008-0222 & 2009-0318

Charges Under the Maryland Medical Practice Act

The Maryland State Board of Physicians (the “Board”) hereby charges David A. Geier (the “Respondent”) (D.O.B. 10/05/1980), an unlicensed individual, under the Maryland Medical Practice Act (the “Act”), Md. Health Occ. Code Ann. (“H.O.”) §§ 14-101 et seq. (2009 Rep. Vol. & 2010 Supp.).

The Respondent is charged under the following provision of the Act:

§ 14-601 Practicing without license

Except as otherwise provided in this title, a person may not practice, attempt to practice, or offer to practice medicine in this State unless licensed by the Board. (1) (2)
The term “practice medicine” is defined in the Act as follows:

§ 14-101 Definitions

(I) – Practice medicine. – (1) “Practice medicine” means to engage, with or without compensation, in medical:
(i) Diagnosis;
(ii) Healing;
(iii) Treatment; or
(iv) Surgery.

Allegations of Fact (3)

The Board bases its charges on the following facts that the Board has cause to believe are true:

1. The Respondent is not and never has been licensed to practice medicine or any other health occupation in the State of Maryland or any other State. The Respondent has a Bachelors of Art degree in biology from a Maryland State university. The Respondent has taken several graduate courses, but has not earned a graduate degree in any specialty or discipline.

2. As detailed below, on October 8, 2008, the Board received a complaint from the mother (“Parent A”) of a former patient of Dr. Mark R. Geier (“Patient A”, below). (4) Parent A complained inter alia that the Respondent examined and diagnosed her son at an office visit on May 19, 2008.

I. The Respondent’s Curriculum Vitae (“CV”)

3. According to the Respondent’s CV, which the Board obtained in furtherance of its investigation, in 2008, the Respondent was a co-founder of ASD Centers, LLC. (5) the slogan of which is, “where medical solutions for autism can be found…” The Respondent is the “Executive Director” of ASD Centers. The Respondent’s father, Mark R. Geier, M.D., (6) is a co-founder of ASD Centers and its President.

4. In the Respondent’s CV, he describes ASD Centers as, “a national network of genetic centers with locations in Missouri, Florida, Texas, Illinois, Indiana, New Jersey and Maryland involved in the evaluation and treatment of more than 600 patients diagnosed with autism spectrum and other neurodevelopmental disorders.”

5. According to the Respondent’s CV, in 1999 he founded and is currently the President of MedCon, Inc., an entity which he describes as conducting “medical-legal consulting and biochemical-epidemiological research.” MedCon’s address is the Respondent’s home address, where he resides with Mark R. Geier, M.D.

6. From 2004 to “the present,” (7) the Respondent was “on staff” at the Genetic Centers of America, which he describes as “[c]enters involved in the evaluating and treat (sic) several hundred patients with autism, neurodevelopmental disorders, and other chronic diseases. In addition, these centers help to provide prenatal genetic care and adult predictive genetic care.”

7. In 2006, the Respondent founded as is currently the Vice President of the Institute of Chronic Illnesses, Inc. (“ICI”), “a non-profit 501(c)(3) foundation dedicated to studying chronic illnesses.” ICI’s address is the Respondent’s home address. Dr. Mark R. Geier is the President of ICI.

8. In 2007, the Responded founded and is currently Vice-President of CoMeD, Inc. [Coalition for Mercury-Free Drugs], an entity described on one of its websites as “a not-for-profit 501(c)(3) corporation that is actively engaged in legal, educational and scientific efforts to stop all use of mercury in medicine and to ban the use of all mercury-containing medicines.” CoMeD, Inc.‘s address is the respondent’s home address. On CoMeD, Inc.‘s website, the Respondent’s father is identified as the Treasurer of the corporation.

Complaint Alleging that the Respondent Practiced Medicine without a License

9. In her complaint, Patient A’s mother (“Parent A”) alleged that the Respondent examined her autistic son during a May 19, 2008 appointment at Genetic Centers of America (also referred to “Genetic Centers of Maryland” or “Genetic Consultants”). Parent A knew both the Respondent and his son, having met them both at a July 2005 consultation. The Board designated this complaint as Case Number 2009-0318. (8)

10. Patient A., was ten (10) years old when he ws initially evaluated by Dr. Mark Geier in July 2005. Patient A had been diagnosed as autistic at age three (3), having regressed in his development when he was two (2) years old.

11. Parent A had been drawn to Dr. Geier’s practice because of his prior research experience at the National Institute of Health (“NIH”) and because she believed that he was an expert on the possible impact of mercury on children with autism.

12. At the initial 2005 visit, Dr. Geier observed some hair development on Patient A’s legs and arms. He also noted that Patient A had received a DPT (9) vaccination in France, after which he had a high fever.

13. Based on his interview with Parent A and his observations of Patient A, Dr. Geier diagnosed him with unspecified developmental delay, possible precocious puberty and possible childhood heavy metal exposure (mercury).

14. Dr. Geier’s plan, as documented in the office note, was to prepare a laboratory work-up to assess Patient A’s current health and potential causal factors for his developmental delays and then to arrange for a follow-up consultation with Patient A’s mother to discuss findings and possible treatment directions.

15. Parent A did not follow-up on the 2005 initial visit. She had sought treatment for Patient A from a neurologist and did not want to interfere with his treatments.

16. In the spring of 2008, Patient A’s mother saw a YouTube video in which Dr. Geier’s theory regarding the causal effect of mercury and testosterone on autism was discussed by a mother of one of his patients. (10) In her complaint to the Board, Parent A wrote:

[r]elying on Dr. Geier’s growing reputation as an expert witness in autism-related court cases, and his credentials as a medical geneticist, I trusted that he had the expertise to performm a competent evaluation and treatment of my son… I thought that Dr. Geier might be able to conduct tests to determine whether there was a genetic basis for my son’s autism, and whether he had high testosterone. It seemed that such testing might offer some insight into his condition, and that the treatment described in the video might offer him some relief and might even eliminate his autism.

17. Parent A scheduled an appointment for Patient A to be seen by Dr. Geier on May 19, 2008 at the Genetic Centers of America’s office in Rockville, Maryland.

18. On May 19, 2008, after waiting with her son for approximately One (1) hour in the waiting room, Parent A and her son were taken to an office where the Respondent was seated behind a desk.

19. Parent A and the Respondent discussed genetic testing for approximately the first half-hour of the visit.

20. Parent A reported that the Respondent, after asking very few questions regarding Patient A’s medical history and symptoms, told her that he was absolutely certain that her son seemed to be a “typical high-testosterone kid” whose growth would be stunted if his testosterone production continued at its current pace.

21. Board staff interviewed Parent A during the course of the investigation, Parent A stated that she did not recall whether the Respondent had identified himself as a physician at the May 19, 2008 office visit; however, she had assumed that the Respondent was a physician because he was the only person with whom she had spoken about her son at that visit. She also noted that the Respondent “had this certainty about him.”

22. At no time during the May 19, 2008 office visit did Parent A see, much less speak to, Dr. Geier. The Respondent was the only person who examined her son.

23. According to Parent A, the Respondent performed an ultrasound examination on Patient A, who by then was too restless to sit or lie still on the examining table. The Respondent told Parent A that he needed an ultrasound of Patient A’s thyroid. The Respondent followed Patient A as Patient A walked around the room, attempting to examine his neck and abdomen by tapping him with the ultrasound wand.

24. When Parent A asked the Respondent how he could possibly obtain an accurate reading under such circumstances, the Respondent replied that everything was “okay” and that the test results were “normal.”

25. The note of the May 19, 2008 visit (11) indicates that “comprehensive” abdominal and thyroid ultrasounds were performed. Patient A’s physical appearance is described as suggesting “advancement from his chronological age.”

26. Prior to seeing the Respondent on May 19, 2008, Parent A completed an Autistic Treatment Evaluation Checklist (“ATEC”) form. (12) Parent A indicated on the form that hitting or injuring others was a “minor problem” (13) for Patient A and that hitting or injuring himself was a “moderate problem.” The only behaviors Parent A described as serious problems were Patient A’s hyperactivity, fixation on certain objects or topics and repetitive movements. Notwithstanding Parent A’s description of Patient A, the Respondent documented that Patient A appeared to be “potentially significantly physically aggressive to himself and/or others.” The Respondent failed to specifically describe Patient A’s aggressive conduct, except that to note that “[Patient A] … can be destructive, his (sic) or injuries (sic) self or other.” The Respondent also noted that Patient A “suffers from significant sleep cycle problems,” although Parent A had noted on the ATEC form that “sleep problems” were only a moderate problem for Patient A.

27. The Respondent documented in “Psychological Examination” section of the note: “It is apparent based upon examination of the DSM-IV criteria that [Patient A]‘s present symptoms are compatible with a diagnosis of pervasive developmental delay – not otherwise specified (sic).”

28. The Respondent documented the following impression: 1) PDD-NOS, (14) 2) Sleep problems (insomnia) and 3) Unspecified Metabolic Disorder. The Respondent’s plan was to prepare a laboratory work-up after which a follow-up consultation would be scheduled to discuss treatment. Twenty-six (26) laboratory studies are listed in the plan.

29. According to Parent A, the Respondent inquired if she was going to have any problems with how expensive the laboratory studies were going to be and discussed the accuracy of results of certain laboratories. Parent A responded that she was not concerned about the price because she wanted to learn whether her son had a genetic basis for his autism and wanted the most accurate results. The Respondent advised that he would have the laboratory order forms mailed to Parent A.

30. Several days after the office visit, Parent A received in the mail a laboratory order for four (4) diagnostic tests to be conducted at Laboratory A (5-Androstane-3, 17-Diol Glucoronide; Androstenedione; DHEA and testicular function). The Respondent indicated that he had completed the form on May 22, 2008 and printed his father’s name as the ordering physician.

31. Upon receipt of the laboratory order form, Parent A called the Respondent because the test order did not inclue the genetic tests she and the Respondent had discussed. The Respondent agreed to send another laboratory order.

32. Parent A received the second laboratory order several days later; it was written for over twenty (20) tests from Laboratory B.

33. According to Parent A, Laboratory B personnel were “flummoxed by the amount of blood needed for the tests” and she instructed them to draw only as much blood as was necessary to assay some genetic conditions, urine metals and porphyrins, the latter because the Respondent has emphasized their importance during the visit. (15)

34. Parent A began to wonder why the Respondent would order so many laboratory tests that required drawing so much blood from children and then searched the internet for more information about the Geiers’ practice. It was from her research that Parent A learned that the Respondent was not a physician.

35. Parent A closely examined the laboratory orders and discovered that the Respondent had written the diagnostic code for insomnia on the first order form; on the second order form he had noted both the diagnostic codes and the diagnoses insomnia, NOS [not otherwise specified] and metabolism disorder, NOS.

36. Parent A did not return to Genetic Centers of Maryland after that May 19, 2008 office visit.

37. In late July 2008, Parent A received billing statements from Genetic Consultants of Maryland with charges listed for four (4) separate dates:
May 19, May 22, June 17 and June 18, 2009. The charges, which totaled $1,200.00, were as follows:

May 19, 2008 – Office Consultation (99215) – $150.00
Neck Ultrasound (76536) – $225.00
Abdominal Ultrasound (76700) – $225.00
Psychiatric Diag[nostic] Interview Exam (90801) – $150.00
May 22, 2008 – Prolonged 1st hour Eval[uation] and Management (99358) – $150.00
June 17, 2008 – Prolonged 1st hour Eval and Management (99358) – $150.00
June 18, 2008 – Prolonged 1st hour Eval and Management (99358) – $150.00

38. After receiving the bills from Genetic Centers of Maryland, Parent A called the office and demanded a copy of all records of her son’s May 19, 2008 evaluation and all of his test results.

39. Parent A received Patient A’s test results from Genetic Centers of Maryland in early September 2008, but as of the date of this document has not received any of the other records she had requested.

40. A Phone Contact Sheet in Patient A’s Genetic Center chart contains three (3) entries: the latter two (2) were written and initialed by the Respondent: (16)

5-22-08: Mailed lab specimen
5-17-08: 2 P.,M. Consultant with [Patient A’]s mother re: lab testing for her son. Reviewed lab scripts and testing procedures at [Laboratory A] v. [Laboratory B]
6-18-08: 9 p.m. Registered & completed lab script for [Patient A] with [Laboratory B] using online 360 software.

Other Genetic Center Patients

41. In furtherance of the Board’s investigation of Dr. Mark Geier, the Board obtained a peer review of the records of nine (9) of Dr. Geier’s Genetic Center patients. A review of those records revealed that the Respondent documented consultations with parents; the results of ultrasound procedures and patient-specific treatment plans in which medications were started or dosages of current medications were revised. In all of the notes discussed below, the Respondent initialed his handwritten notes. Dr. Geier did not initial, co-initial or sign these notes as he did in other notes, nor did the Responent indicate, as he did in other notes, that Dr. Geier was present during the consultations and/or that it was Dr. Geier who made the treatment recommendations.

Patient B (17)

42. Patient B, a female, was nine (9) years and three (3) months old when she initialy presented to the Respondent on May 2, 2007. (18) According to the notes in Patient B’s chart, she was diagnosed with autism at the age of two (2).

43. On October 10, 2007, the Respondent documented an office visit with Patient B’s mother “to evaluate the effects of ↑ Lupron SQ dosing.” The Respondent documented that the “plan is to continue with present dosing. Will re-evaluate & follow-up with mother re: dosing when labs are back.”

44. The Respondent further documented that Patient B’s mother had questioned the use of an antiviral medication. The Respondent noted: “[a]t present, [illegible] [medication] has been agreed by mutual consent to be put off.”

Patient C (19)

45. Patient C, a female, ws eight (8) years and seven (7) months old on March 14, 2008 when she was initially assessed by Dr. Geier during a telephone consultation. Patient C had been diagnosed with ASD at 23 months of age.

46. On June 23, 2008, the Respondent documented an office visit with Patient C. The Respondent documented that Patient C was seen in the office for an examination, review of laboratory results and discussion of a potential treatment plan. The Respondent documented the results of a Wood’s lamp examination, a neck ultrasound and various laboratory results. The Respondent’s note reads in pertinent part:

Assessment is that pt has a toxic encephalopthy & associate ↑ body-burden of heavy metals, partuclar (sic) Hg [mercury], base upon ↑ urinary porphyrins. (20) Pt also has evidence of mitochondrial dysfunction. Additionally, pt has evidence of premature puberty with associated pituitary dysfunction… Plan is to: 1) start Lupron (21) SQ & IM, (22) & Aldactone 50 mg BID (23) for premature puberty; 2) start Carnitor liquid for mitochondrial dysfunction; 3) start B-12 – folonic acid for sulfur-bearing amino SNPs in MTHFR; (24) 4) start vitamin D 1,000 mg IU BID for low vitamin D; 5) start melatonin sublingual for sleep disturbance; & 6) will start metal DMPS (25) in futer (sic) @ present stop all chelation.

47. On January 28, 2009, the Respondent documented “authorized with pharmacist 6 additional refills of Lupron Dept 15 mg kits…”

Patient D (26)

48. Patient D, a male, was was nine and one-half (9-1/2) years old when Dr. Geier initially assessed him during a telephone consultation on March 21, 2006.

49. On January 7, 2008, the Respondent documented a consultation with Patient D’s mother regarding blood in Patient D’s stools. The Respondent noted in pertinent part:

Mother reported she has been recently administering [Patient D] ,mega-doses of vitamin C… Plan is as follows: 1) told mother to keep [Patient D] off high-dose vitamin C… Mother will follow up with us re [Patient D]‘s clinical status.

50. On February 10, 2008, the Respondent documented:

Consulted with [Patient D]‘s mother & reviewed record & decided to get [Patient D] script for Carnitor. Called in Carnitor script to pharmacy.

Internet Communications Regarding the Respondent

51. The internet provides topic-specific forums for interested individuals to exchange idas. In furtherance of its investigation, Board staff reviewed public communications posted in chat groups for parents of children with autism. A sampling of the message pertaining to the Respondent follows. (27)

52. Parent Consultations with the Respondent:

a. Posted January 6, 2007: [the child’s hormone levels are discussed] “David Geier said it’s like she’s in a constant state of PMS. He also said that we will see her ‘move more towards neurotypical.’”
b. Posted June 13, 2007: “…We had our consultation with David yesterday. [The child’s hormone levels are discussed]. David was very nice on the phone and really explained the science.”
c. Posted June 14, 2007: “…David did tell my [x] son that the Lupron might make him ‘not as strong’, but that it would not do much more than that.”
d. Posted July 9, 2007: “I don’t know what to do. David upped the dailies [Lupron SQ injections] from .4 to .5 last week and [the child] is still getting worse… I try to be as prepared as I can with all that is going on with her when David calls.”
e. Posted July 2, 2008: “I spoke with David today and convinced him to try the oral DSMA with [the child] again…”
f. Posted October 3, 2008: “…David Geier recommend (sic) that since [the child] is doing so well on the Lupron that we try to get him off {sic} of all his meds. I did this very slowly… and once we stopped everything it was a disaster!”

53. The Respondent and Dr. Geier as a Team

g. Posted March 21, 2006: [regarding the cost of Lupron injections]: “Yes, they’re expensive, but covered by insurance. I think it’s nice that they Geiers work with insurance companies. If they didn’t, we wouldn’t be able to do this protocol.”
h. Posted March 21,2006: “I love the Geiers — very competent, knowledgable and in this for all the right reasons but please remember that the whole mercury, testosterone, Lupron, etc. is just a THEORY that they are trying to prove.” [emphasis in original]
i. Posted May 22, 2006: “We had a bout of regression when we added DSMA chelation to the protocol… after which the Geiers took her off the chelator.”
j. Posted November 7, 2006: “…the Geiers want to wait to chelate until the aggressions/testosterone is uner control, because the chelation will make it worse… [discussion regarding the child’s body] “which according to David and Dr. Geier, is not so typical of autistic kids.”
k. Posted June 26, 2007: “…I started emailing Dr. Geier and David directly with questions/concerns. And anything of an urgent matter, one of the two gentleman has always called me right away. I also use email to keep them updated on their progress. (I have [x] children on the protocol.)”
l. Posted June 26, 2007: [regarding the start of chelation therapy for one of several children] “Dr. Geier and David just wanted him to be on the Lupron for awhile before starting the chelation.”

54. The Respondent’s Qualifications

m. Posted September 22, 2006: “Dr. Geier (David) explained to me the other night [about the effect of Lupron].”
n. Response to above posting. “Dr. Geier’s name is Mark… David isn’t a doctor. But I’m confident he will get his PhD some day. He sure the heck is smart enough!”
o. Response: “I had found out in August that David is not also a doctor, but it is already a habit for me to call him Dr. Geier… by the time I ‘untrain myself,” He will probably be one! LOL!”
p. Posted December 11, 2006: [Discussion by a health care provider who returned to the “Geiers” after an initial consultation to inquire about Lupron] “First of all Dr. Mark Geier was not in the room the son was giving us the lab result and the treatment protocol. As a [health care provider] I found that to be odd because the son is not an M.D. therefore I felt this was practicing without a license.”

The Respondent’s conduct, in whole or in part, constitutes the practice of medicine without a license, in violation of H.O. § 14-601.

If, after a hearing, the Board finds that there are grounds for action under H.O. §§ 14-601, the Board may impose a monetary penalty.

Notice of Case Resolution Conference

A Case Resolution Conference in this matter is scheduled for Wednesday, July 6, 2011 at 10:00 a.m. at the Board’s office, 4201 Patterson Avenue, Baltimore, Maryland 21215. The nature and purpose of the case resolution conference and prehearing conference is described in the attached letter to the Respondent. If this matter is not resolved on terms accepted by the Board, an evidentiary hearing will be scheduled.

John T. Papavasiliou
Deputy Director
Maryland State Board of Physicians

May 16, 2011


Footnotes

(1) The exeptions referred to in H.O. §§ 14-601 and 15-401 are not applicable to this case.

(2) H.O. § 14-608(a)(4) — Penalties — provides:

(4) … a person who violates § 14-601 of this subtitle is:
(i) Guilty of a felony and on conviction is subject to a fine not exceeding $10,000 or imprisonment not exceeding 5 years or both; and
(ii) Subject to a civil fine of not more than $50,000 to be levied by the Board.

(3) The allegations set forth in this document are intended to provide the Respondent with notice of the alleged charges. They are not intended as, and do not necessarily represent, a complete description of the evidence, either documentary or testimonial, to be offered against the Respondent in connection with these charges.

(4) Patient A in this document corresponds to Patient C in the Board’s Order for Summary Suspension of Mark R. Geier, M.D.‘s medical license. Names of patients and other individuals are confidential. The Respondent may obtain the names from the Administrative Prosecutor.

(5) ASD is the abbreviation for autism spectrum disorder.

(6) Effective April 27,2011, the Board summarily suspended Dr. Geier’s license to practice medicine in Maryland concluding that his treatment of autistic children Lupron, a potent anti-androgen, and in some instances, chelation therapy, constituted a substantial risk of serious harm to the public health, safety or welfare. On May 12, 2011, after a hearing before the Board, the Board issued an Order to continue Summary Suspension.

(7) The Respondent’s CV contains entries through 2009.

(8) The Board had previously opened Case Number 2008-0222 as part of its investigation of Dr. Mark R. Geier

(9) The abbreviation for diphtheria, pertussis (whooping cough) and tetanus.

(10) This individual is President of CoMeD and is a member of ICI’s Institutional Review Board (“IRB”).

(11) The note was typed on a “Patient Interview Form.” Dr. Geier’s name is typed at the bottom of the report, it is neither signed nor initialed.

(12) The ATEC is a listing of twenty-five (25) behaviors and abilities; the individual who completes the form is asked to indicate from three (3) or four (4) descriptive phrases for each behavior that best describes the patient.

(13) The descriptors for the “Health/Physical/Behavior” portion of the ATEC are: not a problem; minor problem; moderate problem and serious problem.

(14) The abbreviation for Pervasive Developmental Disorder — Not Otherwise Specified.

(15) Laboratory B submitted an invoice to Parent A in the amount of $3,915.00 for the laboratory studies that Parent A had requested. Parent A’s health insurance paid $1,169.68 ($2,453.76 had been ‘discounted’); Parent A was billed $292.42.

(16) When interviewed by Board staff in furtherance of its investigation, the Respondent acknowledged that he had written the June 17 and 18, 2008 entries.

(17) Patient B corresponds to Patient E in Dr. Geier’s Order of Summary Suspension.

(18) The vast majority of the Responent’s notes in the reviewed cases were handwritten and consisted of phrases. Several of Patient E’s office notes were typed and consisted of lengthy narratives.

(19) Patient C corresponds to Patient H in Dr. Geier’s Order of Summary Suspension.

(20) The Respondent and Dr. Geier have reported that “[m]ercury toxicity [is] associated with elevations in urinary [porphyrins]… Porphyrins need to be routinely measured in ASDs to establilsh if mercury toxicity is a causative factor and to evaluate the effectiveness of chelation therapy.” Geier, D.A. and Geier, M.R. A prospective study of mercury toxicity biomarkers in autistic spectrum disorder. J. Toxicolol. Environ Health A., 20 (2007).

(21) Lupron is a potent anti-androgen; it lowers the testosterone level the body produces. The only medically accepted use of Lupron for children is precocious (or premature) puberty.

(22) IM is the abbreviation for intramuscular injection; SQ is the abbreviation for subcutaneous injection.

(23) The abbreviation for twice a day.

(24) SNP is the abbreviation for single-nucleotide polymorphism. MTHFR is an enzyme responsible for creating the circulating form of folate.

(25) Chelation therapy is the administration of chelating agents to remove heavy metals from the body. The Respondent and Dr. Geier have reported that high levels of mercury is the cause of autism. DMPS is a chelating agent that thas not been approved by the Food and Drug Administration.

(26) Patient D corresponds to Patient I in Dr. Geier’s Order of Summary Suspension.

(27) The Administrative Prosecutor will provide the specific address of the messages upon the Respondent’s request.

Geiers Sue OAP Petitioners' Attorneys For $600,000 · 602 days ago

Dr. Mark Geier and his son, David Geier have filed suit against the Petitioners’ Steering Committee of the Omnibus Autism Proceeding and the law firm of Williams, Love, O’Leary & Powers, P.C., which coordinated PSC activities, demanding $600,000 allegedly owed for consulting services in vaccine injury and civil litigation.

The lawsuit, filed in the Circuit Court for Montgomery County, Maryland, on April 26, 2011 — one day before Dr. Geier’s license to practice medicine was summarily suspended by the Maryland Board of Physicians — asserts two breach of contract claims against both the PSC and the law firm pertaining to services provided by Dr. Geier; two breach of contract claims against both the PSC and the law firm pertaining to services provided jointly by father and son; and one claim of unjust enrichment by Mark Geier against the law firm. Contracts at issue include a September 18, 2003 consulting agreement between Mark Geier and the defendants, and an October 8, 2004 agreement including David Geier.

In the complaint, Dr. Geier is described as “a physician who is engaged in the practice of medicine, a medical researcher, and provider of expert consultative services and testimony,” and his son David Geier as “an individual who is engaged in the business of helping to provide health-care services, a medical researcher, and provider of expert consultative services.” The complaint further details the hourly fees charged by Dr. and Mr. Geier:

For work related to Vaccine Compensation Act claims:

• $250 per hour for reading time and time spent by Mark and David Geier in their home or office;
• $300 per hour for time spent away from home, including travel and work time but excluding sleep time;
• $400 per hour for time spent giving depositions or other testimony;
• $ 55 per hour for secretarial support; and
• reimbursement of all expenses.
For work related to civil litigation:

• $325 per hour for reading time and time spent by Mark and David Geier in their home or office; and
• $300 per hour for time spent away from home, including travel and work time but excluding sleep time.

The Geiers allege that the defendants agreed to compensate them “on a timely basis regardless of the timing or outcome of any settlement, litigation, or contemplated litigation,” and claim to have regularly submitted invoices, all of which remain unpaid. They demand $600,000, plus 6% prejudgment interest, costs, and a jury trial.

Although included in the original roster of experts filed by the PSC in February 2006, Dr. Geier was not called upon to testify in any of the “test case” hearings.

A scheduling hearing in Geier v. Petitioners’ Steering Committee (Case 346884V) will be held on July 29, 2011.

Maryland Medical Board Suspends Dr. Mark Geier's License · 607 days ago

On April 27, 2011, the Maryland Board of Medical Practice issued a 48-page order summarily suspending Dr. Mark Geier’s license to practice medicine in that state, finding that “the public health, safety or welfare imperatively requires emergency action” to prevent harm to autistic children entrusted to his care.

At issue was Dr. Geier’s implementation of the Lupron Protocol, an experimental autism treatment involving the administration of high doses of a drug that suppresses reproductive hormone function, in combination with chelators intended to remedy alleged “mercury toxicity.” This highly risky, scientifically unsupported regimen, and the battery of tests administered by Dr. Geier to his young patients, is the subject of Significant Misrepresentations: Mark Geier, David Geier, and the Evolution of the Lupron Protocol, a series of investigative articles published on Neurodiversity Weblog in 2006 and 2007. That series subsequently inspired an expose published in the Chicago Tribune that attracted national attention.

The license suspension order describes the treatment of nine autistic children. Testimony to substandard care abounds.

• In six out of nine of these cases, the board determined that the children were misdiagnosed with precocious puberty. Children were diagnosed with precocious puberty without the benefit of a physical examination; some were too old to qualify for the diagnosis.

• Medical records and medical necessity letters prepared by Dr. and Mr. Geier indicated that children were diagnosed not only with precocious puberty, but also with pituitary dysfunction, insomnia, aggression, mitochondrial disorder, metabolic dysfunction, and “heavy metal toxicity” when neither test results nor parent reports suggested anything of the sort.

• In one case, the only record of the diagnosis of precocious puberty was a code number entered onto a standing order for lab tests. In another, no note was made in the medical records of the date the child began treatment with Lupron. Yet another patient’s file contained no indication that Dr. Geier reviewed any of the results of the numerous, burdensome diagnostic tests he had ordered.

• The order describes claims submitted to at least one insurance company for a psychiatric interview and “prolonged evaluation and management” services that were never rendered.

• The order further describes an occasion when David Geier, who is not licensed to practice medicine, conducted a medical evaluation and diagnostic tests, made diagnoses, and recommended treatments for an autistic boy in Dr. Geier’s absence.

• Additionally, the Board determined that Dr. Geier misrepresented his qualifications as a geneticist, and misrepresented the ability of his Institutional Review Board to conduct oversight of his research.

Dr. Geier has been ordered to immediately relinquish his license documents, and all prescription forms and controlled substances in his possession. A post-deprivation hearing has been scheduled for next Wednesday, May 11, at which Dr. Geier is entitled to present any complaints he might have about the processing of his case.

The following is a transcript of all general sections of the license suspension order, not including footnotes or sections describing the treatment of individual children.


In the matter of Mark R. Geier, M.D., Respondent
License Number D24250
before the Maryland State Board of Physicians
Case Numbers 2007-0083, 2008-0454 & 2009-0308

Order For Summary Suspension of License to Practice Medicine

The Maryland State Board of Physicians (the “Board”) hereby SUMMARILY SUSPENDS the license of Mark R. Geier, M.D. (the “Respondent”) (D.O.B. 05/03/1948), licence humber D24250, to practice medicine in the State of Maryland. The Board takes such action pursuant to its authority under Md. State Govt. Code Ann. § 10-226(c)(2009 Repl. Vol.) concluding that the public health, safety or welfare imperatively requires emergency action.

Investigative Findings

Based on information received by, and made known to the Board, and the investigatory information obtained by, received by and made known to and available to the Board, including the instances described below, the Board has reason to believe that the following facts are true:

1. At all times relevant hereto, the Respondent was and is licensed to practice medicine in the State of Maryland. The Respondent was originally licensed to practice medicine in Maryland on September 20, 1979. The Respondent also holds active licenses in the following states: California, Florida, Hawaii, Illinois, Indiana, Kentucky, Missouri, New Jersey, Virginia and Washington.

2. The Respondent is certified by the American Board of Medical Genetics as a Genetic Counselor. In an interview with Board staff, the Respondent false claimed to be a board-certified geneticist and a board-certified epidemiologist. See Section IX, (Misrepresentation of Credentials).

I. The Respondent’s Practice

3. The Respondent is president of Genetic Centers of America with offices located in Rockville and Owings Mills, Maryland. Genetic Consultants of Maryland, according to the Respondent, is “under the umbrella” of Genetic Centers of America. When interviewed by Board staff, the Respondent stated that his current practice includes genetic counseling of high-risk obstetric patients, evaluation of adults for risk of cancer and “genetic work-ups” of children with neuro-developmental disorders.

4. The Respondent also practices uner the name “ASD Centers LLC.” “ASD” is the abbreviation for Autism Spectrum Disorder. ASD Center, LLC’s motto is, “First do no harm.” The Respondent advertises the services provided by ASD as follows:

The ASD Centers, LLC nationwide network, announced a new combined genetic, biochemical, heavy metal, and hormonal evaluation/treatment for patients diagnosed with an autism spectrum disorder (ASD). ASD Centers, LLC founder and medical director, Mark Geier, M.D., Ph.D., FABMG, FACE has provided innovative genetic services for over 28 years, and is a leader in researching and helping to treat patients diagnosed with an ASD.

Researchers from Genetic Consultants studying the biochemistry of autism spectrum disorders (ASDs) have made a major breakthrough in the treatment of the disorder. Evaluations of more than 600 patients diagnosed with an ASD have revealed most have clinical symptoms and laboratory results consistent with high testosterone (the male hormone) and other androgens.

Published peer reviewed clinical trials and treatment of over 300 patients diagnosed with an ASD showed significant clinical improvements following successful administration of testosterone lowering medications. This treatment resulted in rapid and remarkable improvements in autistic symptoms in many patients diagnosed with an ASD with few adverse effects.

5. In or around 2006, the Responded established the Institute of Chronic Illness (“ICI”) of which he is President. His son, an unlicensed individual, is the “Founder and Vice-President” of the ICI. Both the Respondent and his son are members of the Institutional Review Board (“IRB”) of ICI. The mission of an IRB is to protect the rights and welfare of human research subjects. One of the patients whose care was reviewed, Patient I, was enrolled in the “Geier Experimental Protocol for the Treatment of Regressive Autism.” The Consent Form states that the ICI IRB approved the study. As set forth in Section VIII below, the IRB fails to meet federal and State regulatory criteria.

II. The Respondent’s Treatment Protocol

6. The Respondent treated autistic children in seven (7) of the nine (9) cases reviewed. Autism is a heterogeneous syndrome with a broad range of behavioral symptoms and severity. These behavioral symptoms include but are not limited to: disorder of neural development characterized by markedly impaired social interaction, verbal and non-verbal communication, and a pattern of restricted and repetitive behavior.

7. In 2005, the Respondent and his son published in the journal Medical Hypotheses an article entitled, The potential importance of steroids in the treatment of autistic spectrum disorders and other disorders involving mercury toxicity. The Respondent wrote in pertinent part:

Recently emerging evidence suggests that mercury, especially from childhood vaccines, appears to be a factor in the development of the autistic disorders, and that autistic children have higher than normal body-burdens of mercury. In considering mercury toxicity, it has previously been shown that testosterone significantly potentates mercury toxicity, whereas estrogen is protective. …We put forward the medical hypothesis that autistic disorders, in fact, represents a form of testosterone mercury toxicity, and based upon this observation, one can design novel treatments for autistics directed towards higher testosterone levels in autistic children… It is hoped by devising therapies that address the steroid hormone pathways, in addition to the current treatments that successful lower heavy metal body-burdens of mercury, will work synergistically to improve clinical outcomes.

8. In 2004, the National Academy of Science’s Institute of Medicine (“IOM”) published a report entitled, “Immunization Safety Review — Vaccines and Autism.” (“IOM Report”) The IOM Report rejected a causal relationship between vaccines containing thimerosal, a preservative containing mercury, and autism. The report specifically rejected the Respondent’s and his son’s studies that reported findings of such an association, concluding, “the studies by Geier and Geier …have serious methodological flaws and their analytic methods were nontransparent making their results uninterpretable, and therefore noncontributory with respect to causality.”

9. Notwithstanding the rejection of the Respondent’s studies by the IOM, the Respondent developed a treatment protocol whereing autistic children are injected with anti-androgens, including Lupron (leuprolide), to decrease the amount of sex hormones the child’s body produces. Under the Respondent’s protocol, a child receives daily subcutaneous injections (“SQ”) of Lupron, typically administered by a parent, and bi-weekly intramuscular (“IM”) injections administered in the Respondent’s office.

III. Lupron

10. Lupron is a potent anti-androgen; that is, it reduces the amount of testosterons the body produces.

11. It is used to treat adult males with metastatic prostate cancer and adult females with endometriosis and uterine fibroids.

12. Lupron is also used to chemically castrate sex offenders.

13. The only medically accepted use of Lupron in children is precocious (or “premature”) puberty. In this context, Lupron delays the progression of puberty by inhibiting the release of the Gonadotropin Releasing Hormone (“GnRH”), which affects the development of ovaries and testicles. Lupron is not approved for the treatment of autism.

14. With regard to administering Lupron to autistic children, the Respondent has been quoted as saying, “If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”

15. Adverse side effects of Lupron in children include, but are not limited to, risk of bone and heart damage. Lupron is not recommended for individuals with heart disease, kidney disease, asthma or seizure as it may worsen those conditions. Autistic children are prone to seizures. No clinical studies have been completed in children to assess the full reversibility of fertility suppression.

16. The Respondent was reported to have stated in a 2006 radio interview that Lupron is “99% natural” and “if you give it to kids whose normal level of testosterone is zero, and you lower those kids to zero, there are virtually no side effects.” The Respondent also stated: “If you demonstrate that a child has precocious puberty the treatment under mainline medicine, has been for 20 years, is Lupron. Now the only difference is that we get a side effect. The side effect is that they not only lose their precocious puberty, they lose a good deal of their autism.”

17. The cost of Lupron therapy ranges from $5,000 to $6,000 a month. The Respondent has stated that health insurance covers the cost when precocious puberty is diagnosed.

IV. Precocious (premature) puberty

18. The Respondent misdiagnosed six (6) of the nine (9) autistic children whose care is reviewed herein with precocious puberty.

19. The American Academy of Pediatrics has defined precocious puberty as the onset of sexual maturation before age eight (8) in girls and age nine (9) in boys.

20. Precocious puberty is a relatively rare condition. It may be caused by tumors, central nervous system injury or genetic abnormalities.

21. There are no evidence-based publications in the medical literature to support the use of hormonal treatment in children with autism. The Respondent relies on his own studies, which have been discredited by the IOM.

22. The standard of quality care for the treatment of precocious puberty begins with an accurate diagnosis. The standard of quality care for the diagnosis of precocious puberty, in addition to the age criteria, includes: an x-ray of the child’s left hand and wrist to assess skeletal maturation and accelerated bone growth, the result of a sex hormone effect. Unless history and examination suggest an abnormality, no further evaluation is required for children with pubertal milestones that are within one (1) year of population standards.

23. When further evaluation is necessary, the standard of quality care requires: height and weight measurements; physical examination of genitalia (and breasts for girls); measurement of serum levels of gonadotropins and gonadal and adrenal steroids; pelvic and adrenal ultrasound to rule out a steroid-secreting rumor and a computed tomotgraphy (“CT”) scan of the head to rule out an intracranial tumor.

V. Chelation

24. The Respondent has stated that precocious puberty in children with autism is the result of an excessive level of mercury in the child’s blood. In the 2006 radio interview, the Respondent discussed his theory:

If you look at these children, most of them have signs and symptoms of precocious puberty. That’s what David and I have discovered. We’ve discovered that the mercury upsets the pathway that has to do with testosterone, and the testosterone pathway interacts with the glutathione pathway, which is the pathway for eliminating mercury. Most of these kids have precocious puberty and they can be treated. You can look. They have high testosterone, they masturbate at age six, they have mustaches, they’re aggressive, and you can treat them by lowering their testosterone and removing the mercury, and we’ve had unbelievable success. And we’ve been having that. And a number of doctors now are joining us, but they would join us a lot better if the authorities would actually tell the truth about what happened to the children.

25. In some instances, the Respondent’s treatment protocol includes chelation therapy. The Respondent prescribed chelation therapy to three (2) patients described herein and recommended it for three (3) patients. Chelation therapy is the administration of chelating agents to remove heavy metals from the body. For the most common forms of heavy metal intoxication — those involving lead, arsenic or mercury — the standard of care dictates the use of DMSA. Chelation therapy is not risk-free; it is associated with potential adverse side effects such as bone marrow suppression, shock, low blood sugar, convulsions, cardiac arrhythmias, respiratory arrest, and liver and kidney failure, which can be fatal.

26. In the cases reviewed, the Respondent prescribed rectal DMPS suppositories for chelation. DMPS is not approved by the U.S. Food and Drug Administration (“FDA”) and is considered an experimental drug in the United States.

27. With regard to chelation therapy, the 2005 IOM Report states:

The committee found no scientific evidence … that chelation is an effective therapy for ASD or is even indicated only for high-dose, acute mercury poisonings… Moreover, chelation therapy has serious risks; for example, some chelation therapies might cause the rellease of mercury from soft-tissue stores, thus leading to increased exposure of the nervous system to mercury. Because chelation therapy has potentially serious risks, the committee recommends that it be used only in carefully controlled research settings with appropriate oversight by Institutional Review Boards protecting the interests of the children who participate.

VI. Procedural History

Board Case Number 2007-0083

28. On or about August 15, 2006, the Board received a written complaint from an individual who was neither a patient of the Respondent nor a parent of a patient. The complainant alleged that the Respondent promotes the use of Lupron as a treatment for autism in children. The complaint alleged that the Respondent, inter alia:

a. Practices outside the scope of his expertise and the prevailing standard of care for autism;

b. Experimented on children without a rational scientific theory or the supervision of a qualified review board; and

c. Failed to provide appropriate informed consent regarding the potential side effects of Lupron and similar drugs.

29. The Board designated this complaint as Board Case Number 2007-0083.

Board Case Number 2008-0454

30. While conducting its investigation of Case Number 2007-0083, the Board, on or about January 15, 2008, received a complaint from a pediatrician (“Physician A”) who had referred one of his patients (“Patient A,” below) to the Respondent for genetic evaluation and counseling. Physician A complained that the Respondent performed an inappropriate evaluation, made an incorrect diagnosis and treated Patient A inappropriately. Specifically, Physician A reported that the Respondent, whom he noted is not board-certified in either pediatric medicine or pediatric endocrinology, misdiagnosed Patient A with an endocrinological problem based on normal results of laboratory studies. Physician A further reported that the Respondent administered Lupron to Patient A for a “non-existence endocrine problem,” and that his evaluation was “excessive and not based on any evidence-based evaluation algorithms.”

31. The Board designated Physician A’s complaint as Board Case Number 2008-0454.

Board Case Number 2009-0308

32. On October 8, 2008, the Board received a complaint from the mother of a former patient of the Respondent (“Patient C,” below). Patient C’s mother (“Parent A”) alleged that the Respondent’s son was her only contact at a May 19, 2008 appointment at Genetic Centers of America. Parent A knew both the respondent and his son, having met them both at a July 2005 consultation. Parent A reported that the Respondent’s son, after asking very few questions regarding Patient C’s medical history and symptoms, told her that her son seemed to be a “typical high-testosterone kid” whose growth would be stunted if his testosterone production continued at its current pace. Parent A reported that she and her son did not see the Respondent at this visit.

33. According to Parent A, the Respondent’s son performed an ultrasound examination on Patient C, attempting to examine his neck and abdomen by tapping him with the ultrasound want while Patient C was moving around the room. Parent A further reported that the Respondent’s son ordered an extensive number of laboratory studies of Patient C, noting “insomnia” and “metabolic disorder” as diagnoses.

34. The Board designated Parent A’s complaint as Board Case Number 2009-0308.

35. On October 26, 2010, the Board referred eleven (11) patient records, including those of Patients A and C, to a peer review organization for review of the Respondent’s practice. The peer reviewers declined to offer an opinion in two (2) of the cases because the care provided was beyond the scope of their expertise.

36. On January 25, 2011, the Board received the results of the peer review.

Summary Statement in Support of Summary Suspension

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial riskof both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and extensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard quality of care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlyingl medical condition.

The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.

There are no evidence-based studies to support either the Respondent’s Lupron Protocol or his administration of chelation therapy to autistic children; he relies in large part on his own studies which have been wholly discredited by the Institute of Medicine and denounced by the American Academy of Pediatrics.

The Respondent’s treatment of autistic children with his Lupron Protocol and chelation therapy is not limited to Maryland. Indeed, in a recent article in the Chicago Tribune, the respondent stated his intent to open clinics all over the United States, “[w]e plan to open everywhere. I am going to treat as many as I can.”

The Respondent 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.

[individual case studies omitted]

VIII. The Respondent’s ICI IRB fails to meet State and Federal regulations

157. The purpose of an IRB is to protect the interests of human research subjects. In Maryland, research using human subjects may not be conducted unless it is conducted in accordance with federal regulations. Md. Health Gen’l Code § 13-2002(a) and (b). Federal regulations on the protection of human subjects is defined as Title 45, Part 46 of the Code of Federal Regulations (the “Common Rule”). The Common Rule is the baseline standard of ethics to which the institution holds its researchers.

158. An IRB is a committee that monitors all human subject research in an institution to ensure the research is ethical in design and conforms to all federal regulations.l One of the main concerns of the IRB is to minimize the risks of the research and to ensure that the researchers obtain sufficient informed consent that is appropriately documented.

159. The ICI IRB is registered with the Office for Human Research Protection (“OHRP”). The address for ICI is the Respondent’s home address.

160. Because IRBs have the authority to suspend or terminate approval of research that is not being conducted in accordance with ethical principles of the IRB, federal regulations provide that no IRB may have a member participating in the IRB’s initial or continuing review of any project in which the member has a conflicting interest.

161. An IRB must consist of at least (5) members. The ICI IRB’s members include the Respondent, his son and the Respondent’s wife. The ICI IRB is inconsistent with the requirement that a member should not have a conflict of interest in the research project.

162. The IRB noted in Patient I’s “Consent for Enrollment in the Geier Experimental Treatment Protocol for the Treatment of Regressive Autism (IRB00005375) was registered with OHRP; however, it is not linked to any OHRP assurance — the mechanism whereby the IRB commits to adhering to the ethical requirements of the Common Rule.

IX. The Respondent Misrepresented His Credentials

163. On November 6, 2007, in furtherance of the Board’s investigation, Board staff interviewed the Respondent. During the interview, the Respondent stated that he was a board-certified geneticist and a board-certified epidemiologist. The Respondent stated that he had been board-certified in epidemiology in 2007.

164. An inquiry to the Certification Board of Infection Control and Epidemiology revealed that the Respondent is not board-certified in epidemiology.

165. On March 9, 2011, the Board issued a subpoena to the Respondent directing him to provide “any and all” documents to support his claim that he was board-certified in epidemiology and medical genetics.

166. By letter dated March 29, 2011, the Respondent, through counsel, submitted to the Board a “Fellowship Certificate” from the American College of Epidemiology (“ACE”). The ACE is a professional association whose policy on admission is “inclusiveness.” An ACE fellow is not required to have a degree in epidemiology, a degree in a “related field” is sufficient.

167. The Respondent knew, or reasonably should have known, that he was not board-ceritifed in epidemiology.

168. By letter dated March 29, 2011, the Respondent, through counsel, also submitted to the Board a certificate issued by the American Board of Medical Genetics on September 15, 1987, certifyingl the Respondent as a Genetic Counselor.

169. The term “genetic counselor” is not synonymous with “geneticist.” A geneticist, or medical geneticist, is a physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests. A genetic counselor is an individual with a master’s degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.

170. The Respondent knew, or reasonably should have known, that he was not a board-certified geneticist.

Conclusion of Law

Based on the foregoing facts, the Board concludes that the public health, safety or welfare imperatively require emergency action in this case, pursuant to Md. State Gov’t Code Ann. § 10-226 (c) (2) (i) (2009 Repl. Vol.).

Order

Based on the foregoing, it is this 27th day of April 2011, by a majority of the quorum of the Board:

ORDERED that pursuant to the authority vested by Md. State Gov’t Code Ann. § 10-226 (c) (2), the Respondent’s license to practice medicine in the State of Maryland be and is hereby SUMMARILY SUSPENDED; and be it further

ORDERED that a post-deprivation hearing in accordance with Code Md. Regs. titl. 10, § 32.02.05.B (7) and E on the Summary Suspension has been scheduled for Wednesday, May 11, 2011, at 10:00 a.m., at the Maryland State Board of Physicians, 4201 Patterson Avenue, Baltimore, Maryland 21215-0095; and be it further

ORDERED that at the conclusion of the SUMMARY SUSPENSION hearing held before the Board, the Respondent, if dissatisfied with the result of the hearing, may request within ten (10) days an evidentiary hearing, such hearing to be held within thirty (30) days of the request, before an Administrative Law Judge at the Office of Administrative Hearings, Administrative Law Building, 11101 Gilroy Road, Hunt Valley, Maryland 21031-1301; and be it further

ORDERED that on presentation of this Order, the Respondent SHALL SURRENDER to the Board’s Compliance Analyst, the following items:

(1) the Respondent’s original Maryland License D24250;
(2) the Respondent’s current renewal certificate;
(3) the Respondent’s Maryland Controlled Dangerous Substance Registration;
(4) all controlled dangerous substances in the Respondent’s possession and/or practice;
(5) all Medical Assistance prescription forms;
(6) all prescription forms and pads in the Respondent’s possession and/or practice; and
(7) any and all prescription pads on which his name and DEA number are imprinted; and be it further

ORDERED that a copy of this Order of Summary Suspension shall be filed with the Board in accordance with Md. Health Occ. Code Ann. § 14-407 (2009 Repl. Vol.); and be it further ORDERED that this is a Final Order of the Board and, as such, is a PUBLIC DOCUMENT pursuant to Md. State Gov’t Code Ann. § 101-611 et seq.

Harry C. Knipp, M.D.
Vice Chair
Maryland State Board of Physicians

April 27, 2011

Fraud Watchdog Sounds Autism Fundraising Scam Alert · 662 days ago

The St. Louis Better Business Bureau is warning consumers to be cautious about responding to allegedly misleading “fundraising sweepstakes” solicitations from seven nonprofit organizations, including the Autism Spectrum Disorder Foundation, subject of the articles Dialing for Autism Dollars and Waist Deep in the Autism Fundraising Hole, published on this weblog in 2009.

Autism Spectrum Disorder Foundation, Schererville, Indiana

National Cancer Assistance Foundation, Sarasota, Florida (which operates the Breast Cancer Assistance Fund, Children’s Cancer Assistance Fund and Children’s Cancer Dream Network)

Disabled Police Officers Counseling Center, Niceville, Florida

Child Crisis Network, Pompano Beach, Florida

Children With Hairloss, South Rockwood, Michigan (which operates Children’s Sunshine Network)

Circle of Friends for American Veterans, Falls Church, Virginia

Child Watch of North America of Orlando, Florida

The St. Louis BBB’s investigation was prompted by complaints from donors in California and Wisconsin, who contacted the agency due to the involvement of Kirkwood, Missouri fundraising consulting firm Precision Performance Marketing, which developed substantially similar solicitations for each of these nominally “nonprofit” organizations.

Current and former principals of Precision Performance Marketing were at the center of a recent controversy involving the Kirkwood, Missouri charity Reach Our Children, whose founder and president, David J. Lovell, resigned after the St. Louis Post-Dispatch reported that he had failed to disclose to his Board of Directors that his wife, Nancy S. Lovell, was Executive Vice-President and co-owner of Newport Creative Communications of Duxbury, Massachusetts — the very fundraising firm the organization had paid $5.5 million in fees since 2001. That firm was the subject of complaints filed by the attorneys general of 19 states — Arkansas, California, Kentucky, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin — and in 2006 paid $400,000 in fines to settle allegations that it had engaged in “a pattern and practice of misleading and deceptive advertising and solicitation practices.” In July 2008, Reach Our Children was fined $7,500 by the Pennsylvania Bureau of Charitable Organizations for multiple violations of its fundraising regulations, all of which occurred on Mr. Lovell’s watch. The fine was paid by the charity, which survived the debacle with an expanded board and new management; however, in spite of a name change and concerted efforts to combat the negative publicity surrounding the Lovell affair, the organization continues to expend a significant proportion of the donations it receives on the services of for-profit direct mail and telemarketing firms.

Nancy Lovell eventually became Vice-President of Precision Performance Marketing, a position she held until 2010, at which time it was assumed by David Lovell; by virtue of their rank in the firm, both are likely to have been closely involved with developing and conducting the ASDF fundraising campaign. Mr. Lovell has publicly defended as ethical his award of a lucrative fundraising contract to his wife’s business during his tenure with Reach Our Children, and his failure to disclose the potential conflict of interest in legal filings. In addition to his association with Precision Performance Marketing, Mr. Lovell is principal of Data Logix Management LLC, a mailing list broker, list manager and “caging company” responsible for handling donations to fundraising campaigns coordinated by PPM; the ROC Group, a tax-exempt organization purportedly engaged in substance abuse prevention; the National Leadership Foundation, another tax-exempt organization purportedly engaged in Christian evangelism; and the G&P Foundation, a tax-exempt philanthropic foundation.

Accounts of the Autism Spectrum Disorder Foundation “sweepstakes” solicitation developed by Precision Performance Marketing paint a picture of a fundraising strategy that relies on deception and exploitation of the vulnerable. From the St. Louis Post-Dispatch:

Marie Gibson, an 84-year-old woman in California, started receiving the letters sometime last year.

They were all fairly similar, telling her that she was a “confirmed sweepstakes recipient” for “a verified prize amount” of various sums between $6,000 and $8,000. She did not have to send any money back to receive her potential reward, but if she did, the money would go to a charity. A different charity was attached to each letter.

She returned some of the letters, enclosing a $10 or $15 donation. After that, more letters started pouring in.

When her daughter looked more closely at the letters, she realized all of them had a similar St. Louis return address: a post office in Kirkwood. The six-digit post office boxes were nearly identical, too, except for the last two numbers.

“Then I realized what it was,” Gibson said. “They’re picking on people my age. I’m 84, and that’s not right.”

The hail of money-grubbing mail has pelted prospects and donors from all over the country. From the BBB report:

A woman from Racine, Wis., told the BBB she felt misled by several of the recent sweepstakes mailings, including solicitations from Children With Hairloss, Children’s Cancer Dream Network and Autism Spectrum Disorder Foundation. She said she made several small donations to the charities and was inundated with more mailings.

The content of the solicitations appears designed to convince recipients that they have actually won a sweepstakes award, and need only respond to receive the funds already allocated to them:

A Nov. 16 sweepstakes mailing from the Autism Spectrum Disorder Foundation reads: “OFFICIAL DOCUMENT. EXPRESS NOTICE FOR CASH AWARD.” The woman’s name is typed into the space marked, “Recipient’s Name” and “Six Thousand Nine Hundred Twenty Six Dollars” is typed into the space marked “Cash Award.” The letter continues: “I ASSURE YOU I WILL PERSONALLY WRITE YOU A CHECK FOR $6,926 if you send your form in and follow the official rules.” The letter asks for a donation, but notes that no donation is required to win. The reverse side includes information about autism.

As noted in the Post-Dispatch article and BBB report, although the solicitation for each sweepstakes is customized for each organization, donations to all seven organizations go to a single Kirkwood, Missouri post office box — the same box previously used by Reach Our Children for sweepstakes fundraising campaigns. Although Mr. Lovell resigned in disgrace from the organization he used to lead, it would seem that he took the collection box with him — a box now filled with checks from generous citizens convinced that they’re supporting yet another “good cause.”

On the percentage of donations that make their way to the Autism Spectrum Disorder Foundation, the BBB reports:

Autism Spectrum Disorder Foundation reported contributions of about $1.2 million in 2009, with nearly $1.1 million of that raised through Infocision, a telemarketing company, and Precision Performance Marketing. Of the approximately $877,000 raised by Infocision, nothing went to the charity. Of the $203,000 raised through Precision Performance Marketing, about $38,000, or 19 cents of each dollar, went to the charity. The total for both contracts was about 3½ cents for each dollar raised.

The Autism Spectrum Disorder Foundation has been the subject of five complaints to the Ohio Attorney General’s office, including one filed by the Autism Society of Ohio, alleging deceptive fundraising practices. Investigation of the organization’s tactics was discontinued after ASDF submitted documentation of compliance with fundraising laws, which permit charities to spend exorbitant amounts on professional fundraisers as long as at least a tiny fraction of the donations they bring in are returned to the nonprofit itself. More recently, the South Carolina Secretary of State named ASDF in its “Scrooges and Angels” list, pointing to the high percentage of collected donations paid by ASDF to its professional solicitors.

The Autism Spectrum Disorder Foundation’s Form 990 for 2009 (viewable on Guidestar) reports an annual income of $1,200,423 in donations. Although ASDF claims to have spent over $380,000 for “program services” that year, only $31,184 underwrote programs that actually provide direct services to autistic people — that is, programs provided by other organizations, to whom ASDF has made small grants (including one to Autism Pensacola, whose camp director appears untroubled by their new benefactor’s fundraising tactics). The bulk of the remainder represents half the cost of ASDF’s fundraising campaign, which ASDF founder and erstwhile fundraising supplies jobber Michael Slutsky maintains is educational in nature.

A complete record of ASDF’s filings with the North Carolina Charitable Solicitation Licensing Section — including its current contracts with Precision Performance Marketing and Infocision, which provides call center services — can be found on the North Carolina Secretary of State’s website. The final accounting for ASDF’s 2009-2010 fundraising campaign shows that out of $1,165,728.40 raised from donors in the United States, only $60,000.00 — that is, 5.15% — made its way to ASDF — and if the organization’s own tax filings are to be believed, barely half of that amount made it beyond ASDF’s coffers to benefit the autistic people donors thought they were helping in the first place.

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