Geier Suspension Upheld
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• Geiers Sue OAP Petitioners' Attorneys For $600,000
• Maryland Medical Board Suspends Dr. Mark Geier's License
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• 2011 IACC Strategic Plan for Autism Spectrum Disorder Research
• U.S. Supreme Court Ruling in Bruesewitz v. Wyeth
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• A Complete Abandonment Of Principle
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• OSR: The Littlest Consumers
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In early descriptions of the “Lupron protocol” appearing in journal articles, patent applications and public presentations, Dr. Mark Geier and David Geier consistently used the term “precocious puberty” to describe a condition supposedly experienced by “a very large number” of autistic children. Their diagnostic criteria for precocious puberty, however, were admittedly “not that restrictive” — certainly far less restrictive than criteria generally employed by pediatric endocrinologists.
Recent changes in terminology used by the Geiers suggest that they have adapted to the scrutiny of medical professionals capable of recognizing the difference between a serious endocrine disorder requiring pharmaceutical treatment, and non-pathological variations in children’s hormonal metabolism and sexual maturation. Discrepancies between their descriptions of diagnoses given to the young subjects of their study, and the terms used by parents, raise disturbing questions about the accuracy of information provided to insurers in claims for coverage of expenses related to the “Lupron protocol.”
The May 2005 Autism One conference featured two presentations about the Geiers’ then-new testosterone hypothesis and Lupron treatment. The first, Precocious Puberty as an Unrecognized Condition among Children with ASD and Other Disorders Involving Mercury Toxicity, featured Teri Small and Rev. Lisa Sykes — both non-scientists and parents of two of the Geiers’ first three research subjects. Mrs. Small is an editor of Medical Veritas, a periodical devoted to criticism of vaccines and public health policy, and mother to a child whose autism she attributes to damage from both the MMR vaccine and thimerosal. Rev. Sykes is a Methodist minister, Virginia representative of the Coalition for Mercury-Free Drugs, and has assisted the Geiers in editing several journal articles; her name could later be found on the listing of members of the IRB said to have approved the study in which her son was a participant.
Mrs. Small began the session with the announcement:
Both of our sons have mercury toxicity and have been more recently diagnosed with precocious puberty.
Mrs. Small and Rev. Sykes’ talk was accompanied by a Powerpoint presentation featuring many slides identical to slides later displayed by Dr. and Mr. Geier; both slide shows were prepared using the same Powerpoint template. Each mother spent considerable time discussing endocrine function and biochemical metabolism, the development of the Geiers’ hypothesis, and the pharmacological action of Lupron. Both mothers described their children’s diagnosis of precocious puberty; the pharmaceutical treatment of their children with Lupron in conjunction with chelation; and the physical and behavioral improvements that they attributed to the treatment. Rev. Sykes frankly admitted:
Now, I am a divinity student, a minister by trade, and chemistry was one of my least favorite subjects. But I’m going to try to do justice to this, because it is so important.
In spite of her lack of medical credentials, Mrs. Sykes sought to persuade her listeners that laboratory tests are invariably inaccurate and less trustworthy than Dr. Geier’s judgment; that even though her son’s testosterone readings fell within the normal range, administration of Lupron was still appropriate for him; and that his response to the drug constituted a “unique medical phenomenon” newly identified by her mentors.
This is the normal range, but as we talk a little bit further, I think I can convince you that probably his level of testosterone was a multiple of 25 rather than this high reading you see here; I think it was higher.
This is a unique medical phenomenon that the Geiers have identified. This is not the way the curve is supposed to look, as you now know. It seems to be a phenomenon that I’ve been referring to with help from those who are teaching me as “Lupron-resistant testosterone” — it doesn’t want to go down.
Both mothers encouraged attendees to consider testosterone testing and Lupron therapy when considering medical options for autistic children. The presentation ended with Mrs. Small’s exhortation:
My son and Lisa’s son both have mercury toxicity and have more recently been diagnosed with precocious puberty. Let’s move forward with hope towards the future.
Immediately afterwards, Dr. and Mr. Geier gave their talk, titled Thimerosal (Mercury) & Neurodevelopmental Disorders. The presentation began with an overview of their autism causation hypothesis and the biochemical mechanisms by which mercury-induced neurological damage might occur. A discussion followed of unpublished research by University of Kentucky chemist Boyd Haley, who speculated that testosterone increases the toxicity of mercury. Dr. Geier and Mr. Geier cited their December 2004 article, The Potential Importance of Steroids in the Treatment of Autistic Spectrum Disorders and Other Disorders Involving Mercury Toxicity, as well as previously published studies on testosterone and autism. In a section entitled, Precocious Puberty in Children With Neurodevelopmental Disorders: Potential Insights into Testosterone Levels and Potential Testosterone Adverse Effects, they asserted that precocious puberty is “very common” in autistic children, and described their newly-conceived “Lupron protocol.”
Case studies of Rev. Sykes and Mrs. Small’s sons were presented. As the boys’ mothers had done in the previous presentation, Dr. and Mr. Geier identified both children by their full names, discussed their supposedly premature sexual development, and displayed their medical records before a large audience.
Child “W”‘s diagnosis was described.
Prior to considering treatment, his workup showed an elevated serum testosterone level. It was also noted that he had clinical signs of precocious puberty, including increased body hair and sexual masturbatory behavior. Therefore a diagnosis of precious puberty was made.
The clinical findings and diagnosis for Child “I” were similar.
Prior to considering treatment, his workup showed an elevated serum testosterone level. It was also noted that he had clinical signs of precocious puberty, including increased body hair and genital development. (He also had a history of masturbatory behavior.) Therefore a diagnosis of precious puberty was made.
One year later, at the May 2006 Autism One conference, David Geier delivered a lecture entitled, The Biochemical Basis for the Treatment of Autistic Disorders: The Androgen (Testosterone) — Glutathione Connection? (Dr. Geier was in North Carolina testifying in a lawsuit, so Mr. Geier spoke on his own.) As he and his father had done in 2005, Mr. Geier began with a discussion of the “autism epidemic,” the supposed causal relationship between thimerosal in vaccines and autistic spectrum disorders, the work of Boyd Haley, and the “Lupron protocol.”
The term “precocious puberty” had dominated the Geiers’ 2005 presentation; in contrast, in 2006, the term “hyperandrogenicity” — generally used to describe androgen dominance in post-menopausal, obese, diabetic or extremely athletic women — began to appear in its place. The title of the section in the Powerpoint presentation in which hormonal function was described was identical to the corresponding section from the 2005 presentation, except for the diagnostic category: Hyperandrogenicity in Children With Neurodevelopmental Disorders: Potential Insights into Testosterone Levels and Potential Testosterone Adverse Effects.
In spite of the new prominence of “hyperandrogenicity” in the Powerpoint presentation, a verbal slip during the lecture revealed Mr. Geier’s lack of familiarity with the term, and suggested that he regarded “hyperandrogenicity” and “precocious puberty” as interchangeable.
and then we talk about clinical symptoms of premature or hyperandrogenicity in these children — premature puberty or hyperandrogenicity…
Mr. Geier displayed tables detailing the symptoms and test results for sixteen research subjects. These tables were apparently excerpted from a preliminary version of A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders; they contained the same data as charts in the version published electronically ahead of the May 2006 issue, but with different typography. The header to Table 1,
A summary of clinical symptoms/behaviors of hyperandrogenicity among the children with Autistic Spectrum Disorder examined in the present study
had been altered after it was originally prepared. “Hyperandrogenicity” had been inserted into a white space exactly large enough to accommodate the phrase “precocious puberty.”
The “Treatment Overview” section of Mr. Geier’s lecture began with a discussion of the intake process for the Lupron study, in which he introduced yet another heretofore-unmentioned diagnostic category.
Eligibility Assessment and Enrollment
1. Diagnosis of Autistic Spectrum Disorder, including Autistic Disorder or Asperger’s Disorder/PDD-NOS
2. Diagnosis of Testicular Hyperfunction (hypersecretion of testicular hormones), with any one or more of the following features:
a. High blood androgen markers
b. Masturbation, aggressive behavior, body/facial hair
c. One year advanced bone age
As he and his father had done in 2005, Mr. Geier described the case of Child “W.”
“Prior to considering treatment, his workup showed an elevated serum testosterone level. It was also noted that he had clinical signs of hyperandrogenicity, including increased body hair and sexual masturbatory behavior. Mother adds that family and others commented on his height (tall). Therefore the diagnosis of hyperandrogenicity.
Mr. Geier did not explain how, when or why the characterization of Child “W”‘s clinical symptoms and his final diagnosis had been changed from “precocious puberty” in 2005 to “hyperandrogenicity” in 2006.
“Hyperandrogenicity” was consistently used by the Geiers to refer to the subjects described in A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders; that article was originally submitted to Hormone Research in December 2005, and published electronically in May 2006. By using this term instead of “precocious puberty” to describe the children in their study, Dr. and Mr. Geier freed themselves from the obligation to defend any diagnosis that they would not be able to substantiate to the Hormone Research peer reviewers.
As demonstrated above, the shift from “precocious puberty” to “hyperandrogenicity” was also reflected in Mr. Geier’s May 2006 Autism One presentation — except for one telling slip of the tongue.
In contrast, newsgroup posts made during the same time period by parents of study subjects do not feature the same shifts in terminology. Although the Geiers had supposedly modified the diagnosis that would qualify children for participation in their Lupron study, parents didn’t seem to know this. A search for the term “hyperandrogenicity” in the archives of the three most popular Yahoo! newsgroups for discussion of experimental autism treatments — ChelatingKids2, Autism-Biomedical (ABMD) or Autism-Mercury — yields no results. Rather, the term “precocious puberty” continues to be widely used in discussion of the “Lupron protocol.” Parents consistently report diagnoses for CPP that do not seem to include the expected findings upon medical examination and history, but appear to be based largely or exclusively on medical lab test results. Lab test results alone, however, are insufficient for diagnosis of CPP; this requires a detailed physical examination. Parents consistently refer to “mercury toxicity” as a justification for administering Lupron, and they continue to report receiving insurance reimbursement for this costly drug.
In November 2005, a Tennessee mother described herself as “blissfully unaware of the role that mercury plays in this puzzle until I watched the seminar by [University of Kentucky chemistry professor] Boyd Haley PhD.” Over the ensuing months, she told the tale of her newfound understanding of autism, consultations with Dr. Mark Geier, Professor Haley and an unnamed doctor, and her 8-year old son’s Spring 2006 diagnosis of “mercury intoxication” and “precocious puberty.” Three months later, she reported that her son had been “on the Geier protocol” since the beginning of May 2006, and that both the Lupron and chelation drugs were covered by insurance.
Hi, my name is J[…], mom to J[…], diagonsed with atypical autism at the age of 4. I have notice a pronounced up-swing in his cognitive functioning in the past few months. This led me to Generation Rescue, the work of Boyd Haley PhD., and a wealth of information that has changed my perspective on treatment. I found a rescue angel, a clinic in Cordova Tn., and we will go for out 1st appt. Thursday. I am just beginning to feel like there is a light at the end of the tunnel. (November 8, 2005)
I spoke with Boyd Haley friday & he asked me what color I would use to describe my sons coloring. Then Boyd asked if we had ever had his porphyrin level drawn. He thought my son looked pale in the photo I sent to him. (February 22, 2006)
Thank you Dr. Haley! Jimmy’s uro-porphyrin level is 32x normal. Dr. Haley is the Director of the Chemistry Dept., University of Kentucky and has helped our family through this maze. (April 22, 2006)
The test we did was through Lab Corp, #120980-prophoryn quantitave urine (random, though we did a 1st am sample) the results are broken down into 3 catagories, our son’s were all high. Remebber to wrap the sample in tin foil to protect from light. That along with a testicular function study & some genetic studies. Our son’s diagnosis has been changed (by BCBS, our insurance provider) from autism to mercury intoxication. (April 22, 2006)
The Doc. used standard ICD-9 codes, with supporting lab work, what choice did they have? (April 23, 2006)
Dr. Haley is in the process of getting 2 new chelators to market, I’m not sure where he is in the process, he has filed an investigational drug app. with the FDA. My son isn’t a gut kid, so we will be using oral DMSA & Lupron through Dr. Geier. Both precocious puberty & mercury intoxication are ICD-9 coded diaginoses. Insurance has no choice, we’re covered. The whole process has been amazing. Both Dr. Haley & Dr. Geier asked us the same questions after seeing a photo of our son & reading his vaccine history. Dr. Geier has been wonderful. Our son fit the protocol to a T. (April 23, 2006)
My son has been on the Geier protocol for 55 days total. We give 10mg/kg DMSA by mouth 3 times a day, (every 8 hours) every other day. We supplement on “off” days. He has had 26 day on DMSA. He has never been a gut kid, so that is a battle I have never faced. It took about a month to get all the genetic lab work done, once we were sure mercury was our problem we began the protocol. Our son was 8, his testosterone level was 2&1/2 times normal & his porphorin levels were 32 to 88 times normal, I don’t have his labs handy, & I can’t remember which of the porphin levels was so high. His DHEA was high, his DHEAs (sulfate pathway, was non existanant). […] Our insurance covers the non depot lupron and the Chemet under our Rx co-pay, the depot lupron is covered by major medical, once we meet our deductable, we are covered at 100%. (June 25, 2006)
Over the first six months of 2006, a Chicago-area father reported on his 7-year old autistic daughter’s diagnosis of “precocious puberty,” her ongoing treatment, and his dealings with insurance companies. He ultimately admitted that she is “not technically precociously pubescent,” a situation that did not appear to interfere with his ability to obtain insurance reimbursement for Lupron.
My daughter just went through all the blood testing to see if she’s a candidate for the Geier’s protocol. I’ll have the results in a few weeks…I’ll keep everyone posted. (January 14, 2006)
We’re treating her high testosterone under the Geiers’ “lupron” protocol, since their discovery that high testosterone helps to trap mercury in the body. (March 20, 2006)
There is a new sub-cutaneous injection that just goes directly under the skin. The intramuscular form lasts about a month, but there are peaks and valleys in its effectiveness, according to the Geiers. They found more consistent results with the sub-cutaneous shots. One a day, in the buttocks is what we do with our daughter. The needles are very thin, and not very long. She never flinches during the injection. It’s easy to do. There’s a multi-dose vial of the drug that you swab with alcohol (at the rubber seal). You unwrap the single-dose syringe, draw air into it (equal to the dose), inject the air into the vial, turn the vial upside down… and draw the drug into the syringe. It’s really simple. Yes, they’re expensive, but covered by insurance. I think it’s nice that the Geiers work with insurance companies. If they didn’t, we wouldn’t be able to do this protocol. (March 21, 2006)
You just call their office manager, Eleanore. She sets up an initial phone consultation, and depending on THAT, they would possibly order a battery of tests. (April 13, 2006)
This last week we ran out of lupron due to a mixup with our insurance company. She regressed some after just two days without lupron. We’re starting her on it again, tonight. (April 15, 2006)
It doesn’t matter to me if there’s a chance that their model of the testosterone/mercury complex may be wrong. Just that we’re sure that using Lupron for precocious puberty is going to lower my child’s high testosterone, improve her behavior… her learning… lessen or eliminate her tactile defensiveness… and give us all the wonderful things we’ve been seeing since we started… and that it’s going to help her during chelation therapy to avoid the meltdown tantrums and aggressiveness associated with spikes in her testosterone levels. It’s working VERY well. (April 25, 2006)
Are they consulting with endocrinologists, etc.? I haven’t asked. But yes, they are using the diagnosis of precocious puberty. And why not? High testosterone (very high) causes precocious puberty (in boys, anyway) …and most of the kids they’re treating are reach puberty way too early. (April 27, 2006)
While my daughter was not “technically” precociously-pubescent… she had abnormally high testosterone… enough to put a boy her age into precocious puberty. Conversely, she had NO estrogen, which was strange. Using Lupron as a method to detox heavy metals is a novel use of the drug… but really that’s just an effect of treating a verifiable medical condition (which is abnormally high testosterone). (June 20, 2006)
The spacing of a San Diego father’s posts indicates that his now-10½ year old son has been administered Lupron over a ten-month period.
We just started the protocol. As of a few days ago, there were about 12 kids on it. (August 2, 2005)
Our son is on their protocol. If you have questions, feel free to call me at the number below. (June 2, 2006)
For such protracted treatment, the cost of Lupron Depot alone would total $15,000-$20,000; expenses for supplemental subcutaneous leuprolide, chelation drugs and lab tests could raise that total by at least another $5,000.
It is highly unlikely that most families would be willing to pay out-of-pocket for such an expensive, experimental pharmaceutical regimen, unless a family member were suffering from an imminently life-threatening condition for which there were no alternate treatment. It is also highly unlikely that insurance companies would reimburse parents for Lupron prescribed to autistic children for “hyperandrogenicity” or “testicular hyperfunction.” “Hyperandrogenicity” is not recognized in the International Classification of Diseases (ICD-9-CM), and therefore lacks the corresponding ICD-9 code required for the processing of insurance claims. Neither “hyperandrogenicity” nor “testicular hyperfunction” are conditions for which the FDA has approved Lupron for pediatric use. CIGNA’s Health Care Coverage Position for Leuprolide (Lupron), for example, explicitly limits coverage of Lupron to the treatment of central precocious puberty. Certainly no females could be diagnosed with “testicular hyperfunction,” yet Dr. Geier and Mr. Geier have publicly stated that they seek to treat females, and several parents of girls (such as the father quoted above) have publicly stated that their daughters are being administered Lupron.
All of these changes and inconsistencies raise the question — have Dr. Geier and Mr. Geier begun to use terms such as “hyperandrogenicity” and “testicular hyperfunction” in journal articles and public presentations about their testosterone hypothesis and the “Lupron protocol,” while they and cooperating doctors continue to enter the more reimbursement-friendly diagnosis of “precocious puberty” on their patients’ insurance claims?