|
|
第一名:
2011年5月3日,马里兰州医疗管理局宣布吊销Dr. Mark Geier的行医执照.
Dr. Mark Geier和他的儿子David Geier是坚定的"疫苗导致自闭症"的拥护者,他们自创了所谓的"Lupron Protocol",Lupron是用来抑制性荷尔蒙的生长,常常被用于法律上对强奸惯犯的"化学去势",这父子俩相信这是治疗自闭症的神药,和"螯合治疗"一起可以去除重金属汞,从而治愈自闭症.
马里兰州医疗管理局经过调查,发现了很多误疹和用医不当的病例,从而决定吊销执照.
Maryland Medical Board Suspends Dr. Mark Geier's License · 2011-05-03 19:00
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.
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.
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]
|
|
IP卡
狗仔卡
发表于 2011-5-6 22:41:23
收藏
分享
提升卡
置顶卡
沉默卡
喧嚣卡
变色卡
显身卡
楼主