Blood & Data · 2006-08-25 13:10


Significant Misrepresentations
Mark Geier, David Geier & the Evolution of the Lupron Protocol
(Part Nine) • Related articles

In their article, A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders, Mark and David Geier described to the scientific community their method for studying autistic children’s metabolism:

The Institutional Review Board of the Institute for Chronic Illnesses (Office for Human Research Protections, US Department of Health and Human Services IRB number: IRB00005375) approved the present study. In this study, consecutive pre-pubertal age children (<= 11 years old) with previously diagnosed regressive ASDs (Autism or Pervasive Developmental Delay – Not Otherwise Specified) that presented from November 2004 to November 2005 to the Genetic Centers of America for outpatient care were evaluated. A total of 16 patients with ASDs were identified (mean 8 SD: 5.9 8 2.1 years old). These patients had been determined to be negative for Rett’s Syndrome, Angelman/Prader-Willi Syndrome, Fragile-X Syndrome, chromosomal abnormalities, chromosomal sub-telomere abnormalities, inherited metabolic abnormalities (LabCorp, Inc.). The patients had no brain structural abnormalities (CT or MRI head scans) or adrenal abnormalities (abdominal ultrasounds). The patients were also tested and determined to be negative for polychlorinated biphenyls/chlorinated pesticide exposure, thyroid function abnormalities, kidney function abnormalities, and liver function abnormalities (LabCorp, Inc.). A clinical examination was undertaken for each patient to evaluate clinical symptoms/behaviors of hyperandrogenicity such as early growth spurt, increased body and facial hair, aggressive behavior, and early secondary sexual changes. Children were tested for androgen metabolites including serum total testosterone, serum/plasma dehydroepiandrosterone (DHEA), and serum follicle-stimulating hormone levels (LabCorp, Inc.) and for methionine cycle-transsulfuration pathway metabolites including plasma methionine, serum cystathionine, serum homocysteine (LabCorp, Inc.), plasma cysteine, and plasma reduced glutathione (Great Smokies Diagnostic Laboratory).

During his presentation at the 2006 Autism One conference, David Geier discussed this “Eligibility Assessment and Enrollment” process in more informal terms, displaying and explaining the purpose of a lengthy list of laboratory tests:

And when we do workups on patients, we do a very large screening so that we get a very pure kind of population when I show you this data. We do testing on all of our patients to look at all of these different factors that you see here on these slides. And what we’re looking at is to try to rule out known causes or potential causes for autistic disorders. And we have a whole panel of DNA tests, looking for Rett’s, Angelman, Prader-Willi, Fragile X and so on. And then we’re very interested in what’s structurally going on in the brain. Structural anomalies of course can cause autistic-like problems, but also that can cause problems with testosterone. So we look to evaluate that. We also look at adrenal anomalies as potential problems with testosterone. So we’re doing this whole list of things here and ruling each one of them out. (May 26, 2006)

The following list includes links to LabCorp pages describing each of the 33 tests included in the Geiers’ eligibility assessment, followed by preferred and minimum amounts of blood to be drawn, and the price of each test as of August 18, 2006. (Thanks to LabCorp’s anonymous customer service representative for providing price information.)


Test Volume (Min) Cost
Blood Tests: Endocrine
Testicular Function Profile II 3.0mL (1.5mL) $519
DHEA 0.3mL (0.1mL) $204
DHEA-Sulfate 1.0 mL (0.4mL) $132
Thyroid Profile II (Comprehensive) 2.5mL (1.0mL) $264
Androstenedione 0.3mL (0.2mL) $184
Dihydrotestosterone 1.0mL (0.5mL) $113
5-Androstane-3, 17-Diol Glucuronide 0.3mL (0.2mL) $288
Blood Tests: Genetic
Fragile-X 10.0mL (7.0mL) $404
Rett Syndrome, DNA Analysis 7.0mL (3.0mL) $550
Angelman/Prader Willi Syndrome 7.0mL (3.0mL) $483
Chromosome Karyotype 5.0mL (2.0mL) $716
FISH TELO-SCAN, Subtelomere 10.0mL (2.0mL) $1,177
MTHFR 1298 and 677 7.0mL (3.0mL) $256
Blood Tests: General
Complete Blood Count (CBC) with Differential 3.0mL (3.0mL) $37
Metabolic Panel (14) Comprehensive 5.0mL (5.0mL) $46
Plasma Amino Acids, Quantitative 4.0mL (1.0mL) $763
Anemia, Megaloblastic Serum 2.0mL (1.0mL) $316
PCB/Chlorinated Pesticide Exposure Profile 9.0mL (4.2mL) $460
Heavy Metals Blood Profile II 7.0mL (1.1mL) $428
Celiac Profile 3.0mL (1.0mL) $256
Lipid Panel 1.0mL (0.5mL) $87
Serum Zinc 2.0mL (0.6mL) $91
Serum Copper 1.0mL (0.2mL) $91
Magnesium, Serum 1.0mL (0.5mL) $49
Manganese, Blood 2.0mL (0.5mL) $157
Selenium, Blood 2.0mL (0.6mL) $147
Vitamin A 5mL (2.0mL) $111
Cobalt, Plasma 2.0mL (0.6mL) $157
Vitamin B12 and Folates 1.5mL (0.6mL) $184
Vitamin B6, Plasma 5.0mL (1.0mL) $185
Urine Tests
Urine Organic Acid Analysis 10.0mL   $218
Common Alloy Elements Profile, Urine 15.0ml (7.5mL) $854
Porphyrins, Qn, Random, Urine 25.0mL (5.0mL) $118
33 Tests 109.9mL (47.3mL) $10,045

The total maximum blood draw required to complete all of the above tests is 109.9mL, or 22 small (5mL) blood collection tubes. At the minimum, 47.3mL, or 10 small tubes would need to be collected. (Blood samples would also be required for the Great Smokies Diagnostic Laboratory plasma cysteine and plasma reduced glutathione tests, described in the Hormone Research article but not included in the list displayed at the 2006 Autism One conference.)

Parents have described evaluations of their children for participation in the Geiers’ study, and for possible treatment with Lupron in conjunction with chelation; these include extensive bloodletting.

Administering of lupron is only after 35 tests, 4+ sessions of blood drawing with 3-4 vials at each draw. […] He is 35 lbs. (February 27, 2006; June 1, 2006)
My son just started the Geiers study. Did our first round last weekend, started the Lupron 3 days before that… You have to do a LOT of bloodwork as a prelim. 10 vials worth for us. […] He is about 48 lbs and almost 6. (March 16, 2006; June 2, 2006)

Judging from the above statements, Dr. and Mr. Geier require a minimum 50ml blood draw from their young patient/subjects. (It is unclear whether this amount is ever drawn from a child in a single session, or if this is routinely done in several installments.) Follow-up testing, too, involves periodic blood draws:

What they measure is blood-serum levels of the testosterone every two weeks. (May 23, 2006)

Although all too often medical professionals and parents will minimize the impact of blood draws on children, with reasoning such as,

It doesn’t hurt to test and see where his levels are at…

phlebotomy is, in fact, a procedure that poses specific risks if performed to excess. These risks include pain, soreness, bruising, infection, numbness, paralysis, loss of consciousness, anemia, and nerve injury. Phlebotomy also poses a risk of psychological trauma — especially for individuals with pronounced fear of needles, anxiety, tactile defensiveness, and in situations involving restraint. As one mother of an autistic child acknowledged,

We have had blood drawn for various tests in the past, and it was traumatic, for both of us.

In both medical care and research, it is generally preferable to withdraw from any individual the smallest amount of blood needed for any procedure. Although increased exposure to risk may be warranted when a child is acutely ill, it is less justifiable to expose any child to risk primarily for solely investigational purposes.

FDA regulations (21 CFR Parts 50 and 56: Protection of Human Subjects) define “minimal risk”:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

In a 2004 survey of IRB chairpersons, respondents were asked to categorize the risk posed to children by blood draws, as well as the risk level of a blood draw each week for six months. While 81% responded that a single 10mL blood draw posed only a minimal risk to children, 17% felt that the risk was greater than minimal. 51% of respondents felt that weekly 10mL blood draws taken over a six month period posed a minor increase over minimal risk, and another 32% felt that such a regimen would pose more than a minor risk. Only 15% regarded repeated blood draws as minimally risky.

The chart at right (data from Textbook of Clinical Laboratory Supervision) provides widely accepted guidelines for the maximum amount of blood to be drawn at one time from patients weighing under 100 pounds. For any child weighing under forty pounds, only two 5mL tubes should be collected during any given blood draw session.

The sixteen children described in A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders, ranged in age between three and ten years old. The weight of each child can be estimated by referring to tables of children’s average growth (figures rounded to the nearest whole number):

3 3-year old boys 35 lbs.
2 4-year old boys 40 lbs.
3 5-year old boys 45 lbs.
1 6-year old boy 49 lbs.
4 7-year old boys 55 lbs.
1 7-year old girl 54 lbs.
2 9-year old boys 69 lbs.
1 10-year old girl 77 lbs.

If the Geiers’ study participants were of average weight, and if blood was drawn from each in an amount and rate similar to the aforementioned parent accounts, more than half of those children are likely to have had blood drawn in excess of the above guidelines. According to the first parent quoted above, 150%-200% of the maximum recommended amount of blood was drawn from his 35-pound son, in each of several sessions.

The substantial blood draws prescribed by Dr. and Mr. Geier upon entry into their Lupron-chelation study and for ongoing monitoring seem to reflect little consideration of the risk of harm posed to the autistic children who are their research subjects. The test battery also seems to reflect little concern for cost containment or appropriate test sequencing. As noted in the above chart, the total price tag for LabCorp tests included in the Geiers’ eligibility assessment exceeds $10,000; their diagnostic shopping list includes newly developed assays that are not covered by most standard health insurance policies.

For instance, FISH TELO-SCAN, Subtelomere is an advanced screening test used to analyze anomalies in the subtelomere — that is, the region of a chromosome immediately preceding its end segment. The test is generally conducted after known genetic causes of cognitive delay (such as Fragile-X, Rett’s, Prader-Willi and Angelman Syndrome) have been ruled out, rather than concurrently with other genetic tests. Although FISH testing is enthusiastically promoted by genetic testing laboratories (including by Genzyme, to whom Mark Geier sold his business, Molecular Medicine, in 2003), research on its use in autism screening is in its infancy, and its clinical practicality is a subject of debate. One recently published study concluded that subtelomeric analysis is “useless” for the majority of individuals with autistic spectrum disorders; others have suggested that such testing be focused on individuals with severe dysmorphic features, or whose family history warrants it. The American College of Medical Genetics concurs with the latter assessment, recommending that subtelomeric FISH testing be reserved for children with clinical features suggestive of a particular genetic syndrome, after chromosome analysis has yielded normal results. The American Academy of Pediatrics advises that most subtelomeric abnormalities detected by FISH cause syndromes that are not yet fully delineated, and that readings can be misleading, referring to examples in which anomalies detected by FISH techniques have proven to be benign familial “variations” and not the cause of a child’s disability.

About the $1,177 FISH TELO-SCAN, Subtelomere procedure, LabCorp warns consumers:

Because this procedure is new, Medicare and other carriers may not consider it as a covered benefit for patients. This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.

A similar caveat appears in the description of the MTHFR 1298 and 677 test, which identifies genetic polymorphisms associated with folate deficiency.

For Investigational Use Only. The performance characteristics of this procedure have not been established.

The MTHFR test is only medically indicated for the follow-up evaluation of individuals with hyperhomocysteinemia, and evaluation of patients with venous thrombosis. The “For investigational use only” label required by the FDA indicates that no data exist to demonstrate that the test can independently diagnose any medical condition or provide any clinically useful information.

Dr. and Mr. Geier have indicated that the costly genetics portion of the eligibility assessment is intended to “rule out” genetic causes of autism, and to validate Dr. Geier’s differential diagnosis of mercury-induced autism.

As I said, we run a very extensive laboratory workup on our patients to rule out all kinds of other causes. (David Geier, May 26, 2006)
Before we put anybody on this treatment we make sure they really have mercury poisoning or regressive autism. So for example, we do chromosomes. If they have Fragile X, well, then they’re not for the treatment; it they have Rett Syndrome, they’re not for this treatment. (Mark Geier, June 23, 2006)

However, screening for Fragile X, Angelman Syndrome, Prader-Willi Syndrome, and Rett Syndrome, is generally conducted by specialists in pediatric genetics; tests for these disorders are medically indicated only if a patient displays specific personal and family history characteristics. Further, tests for these disorders can only rule out the specific disorders tested — they do nothing to “rule out” genetic causes of autism which have not yet been identified, and for which tests are not yet available. Judge James A. Beaty addressed Dr. Geier’s logic on this subject in his opinion in Doe vs. Ortho-Clinical Diagnostics:

[T]he Court finds that Dr. Geier’s application of the differential diagnosis technique suffers from its own irregularities. First, the Court notes that Dr. Geier is not a pediatrician or a pediatric neurologist. In fact, testimony was presented to the Court that Dr. Geier was not even successful in sitting for his Medical Board examination in the specific field of pediatric genetics. Thus, there is a threshold question as to whether Dr. Geier is even qualified to perform a differential diagnosis so as to give a causation opinion with respect to the cause of a neurological disorder such as autism in a child such as Minor Child Doe. More troubling, however, is that Dr. Geier’s differential diagnosis failed to acknowledge the one conclusion that is generally accepted in the medical community with respect to the causation of autism, which is, that its cause is genetic, but that the exact genetic sequence of autism is unknown. From the evidence presented to the Court, this appears to be the prevailing medical view on the subject of autism among experts in the field. Dr. Geier does not even profess to be, nor has he or any other proposed expert witness for Plaintiffs tendered to the Court, an expert on autism. Although Dr. Geier apparently has considered a number of specific genetic disorders in performing his differential diagnosis, the Court finds that his failure to take into account the existence of such a strong likelihood of a currently unknown genetic cause of autism serves to negate Dr. Geier’s use of the differential diagnosis technique as being proper in this instance… [T]he Court finds that Dr. Geier (1) was not specifically qualified to perform a differential diagnosis of a pediatric neurological disorder, and, that (2) he did not properly perform the differential diagnosis given his failure to consider within his analysis the high probability that an unknown genetic cause cannot be ruled out as the specific cause of Minor Child Doe’s autism. For these reasons, Dr. Geier’s testimony on specific causation based upon a differential diagnosis must be excluded under Federal Rule of Evidence 702. (July 6, 2006)

The Geiers’ test battery cannot compensate for the lack of professional qualifications to diagnose autistic spectrum conditions, and is inadequate to “rule out” any and all genetic contributions to autism. It also cannot compensate for the lack of professional qualifications to diagnose endocrine disorders, and is inadequate to validate a diagnosis of precocious puberty. In their article, Disorders of Puberty, Drs. Richard Blondell, Michael Foster and Kamlesh Dave of the University of Louisville School of Medicine detail the basic tests generally used by pediatric endocrinologists for this purpose (in 1999, these were estimated to cost approximately $650).

Further diagnostic testing is used to confirm the initial impression of idiopathic precocious puberty, to localize the abnormality of the pathologic cause or to determine which imaging study to obtain. Tests for this purpose include serum levels of FSH and LH, estradiol, testosterone, thyroid-stimulating hormone, thyroxine and human chorionic gonadotropin… If a central pathologic cause is suspected after hormone measurements are obtained, magnetic resonance imaging of the brain and pituitary gland, a GnRH stimulation test, or both, may be indicated. The GnRH stimulation test is performed by administering 100 µg of GnRH either intravenously or subcutaneously after overnight fasting. Serum levels of FSH and LH are measured at baseline just before the injection and at 15, 30, 45 and 60 minutes after the injection. Test interpretation is controversial, and the pattern of increases of FSH and LH vary with the stage of puberty, but if the patient has central precocious puberty, the hypothalamic-pituitary axis will have been activated, and a two- to threefold rise in FSH and LH will be observed.

In spite of the fact that Dr. and Mr. Geier are recommending and prescribing a drug whose only FDA-approved pediatric use is for the treatment of precocious puberty, their screening process does not include the GnRH (gonadotropin-releasing hormone) stimulation test. This dynamic test of pituitary function is essential to discriminating between “central” precocious puberty and accelerated development that is the consequence of a lesion or tumor, and to monitoring the effectiveness of Lupron therapy for central precocious puberty. (An abbreviated form of the test is offered by LabCorp.)

According to David Geier’s 2006 Autism One Powerpoint presentation, the eligibility assessment for his and his father’s Lupron study includes not only blood and urine testing, but a physical examination, including:

Wood’s Lamp
Head MRI
Hearing Exam
Vision Exam
Abdominal Ultrasound

The omission of the time- and labor-intensive GnRH stimulation test and the relegation of physical examination to the end of the list is not surprising. Although in their Hormone Research article Dr. and Mr. Geier stated that CT scans, MRI, and abdominal ultrasounds had been performed on their patients, parents far from Maryland frequently describe the Geiers’ provision of medical consultation, diagnostic and treatment services, test orders and prescriptions for drugs, via telephone consultations, but seldom in in-person office visits.

Interestingly enough, I had a phone consult with the Geiers today, we’re getting ready to start their Lupron protocol. He gave me this huge long explanation of how mercury messes up your testosterone which messes up glutathione, and went into a long list of levels which are depleted in evidence of this — homocysteine was one of them. Other things my son was low in which points to low glutathione are Glutamic acid, Glycine, Cystine, Creatinine, and Cystathione. […] [T]he Geiers charge 300/hr consult fee, I’ve only had to talk to them 2x so far. they order all their own labs, I don’t see why you’d need a local Dr. in addition, unless you needed someone to do the injections for you. (California, January 30, 2006; March 16, 2006)
My son just finished his tests for the Geiers and we are waiting for results. Dr. Geier uses a special lab that will reference D[…]‘s level with boys his own age. We live in NH so it is possible to be a patient of the Geiers’ Just a lot of phone consultations. (New Hampshire, February 5, 2006)
Dr G will do it with your Dan and a phone consult. They’ll want your charts that you have from your son’s birth and order up 33+ tests, much of which will be paid by insurance. (North Carolina, April 27, 2006)
The Geiers can have him tested long distance. They PREFER to be able to see the child, because they like to perform one test in person… some abdominal sonogram… but we couldn’t make it out there either. Nevertheless, we had a few consultations over the phone, ordered a huge battery of tests at Labcorp (who works with insurance) and discovered M[…]‘s needs. She’s on the protocol, and we didn’t have to fly to Maryland. (Illinois, April 5, 2006)
We are starting Geiers protocol this month. … My son is 9 and his testosterone levels (FSH, LH…) were not indicating precocious puberty. Then we did a bone x-ray (hand) and he had a bone age of a 12.9 year old. With that he qualified for Lupron. This proves to me that some of the testosterone was bound w/mercury. This is my opinion. His Endocrinologist was scratching his head. (California, May 8, 2005; June 4, 2005)

Perhaps the endocrinologist was scratching his head in puzzlement at the idea that testosterone “binds” to mercury, or that any mother might be eager to administer Lupron to her child in the absence of any visible indications of precocious puberty, or that any doctor would prescribe Lupron in absentia, basing his decisions solely on the results of laboratory tests — procedures that are no substitute for a detailed, on-site, first-hand physical examination. Although laboratory tests provide information that “cannot be seen, heard or touched by the doctor,” excessive laboratory tests can produce a surfeit of extraneous information and detract from accurate diagnosis. As surgeon-blogger Orac has observed,

[I]f you screen for 30 lab values in almost anyone, you have a good chance of finding at least one that’s abnormal. The reason for this is that “normal” for most laboratory values is defined as the range that encompasses 95% of the normal population without conditions that could be expected to change the lab value. Consequently, 5% of “normal” patients will have an abnormal value in any single lab test. If you screen for 20 lab values, there’s a close to a 100% probability that one of the tests will be abnormal. Testing for 30 or more lab values, there’s a pretty good chance that two or more of them will be abnormal. (Indeed, when peer reviewing papers, I have rejected papers that were guilty of looking at many variables without using statistics to control for multiple measured lab values or parameters for that very reason.) By using a “shotgun” workup, the Geiers almost guarantee that almost every child they test will fit into their diagnostic criteria. (June 28, 2006)

Excessive testing can also be used to create an inaccurate impression that a doctor is “doing all he possibly can” for his patients — even if he never meets them in person — and to conjure up dubious evidence of pathology in healthy individuals. Such an outcome is practically inevitable in the Geiers’ study, given their promise that an autistic child need display only a single “abnormal” test result to qualify as a “candidate” — that is, a child to whom Lupron can be prescribed as if it were medically indicated, and who can simultaneously serve as a research subject.

What we look for are markers of high androgens. This is a list of the kinds of things that we’re testing. And really, to try to treat patients, we’re looking for one of those, at least one, preferably more of those to be abnormal, with the autism… As far as that list, you don’t have to have all of those… one or more of those usually is what we’re looking at, for at least a candidate, so it’s not that restrictive. (David Geier, May 26, 2006)

A Cautionary Tale

The following discussion-list posts shed light on the cumulative test and medication load borne by all too many children in the primary candidate pool for the Geiers’ Lupron study — that is, the autistic sons and daughters of parents convinced their children are “mercury toxic,” who are often treated by numerous doctors and subjected to a variety of nutritional and pharmaceutical “therapies.” They shed light on the Geiers’ recruitment and evaluation process for treatment candidates and control subjects; on the manner in which they convey medical information to parents; and on the expenses potentially borne by families whose insurance companies refuse to cover the costs of laboratory testing deemed medically-unnecessary.

Several months after joining several popular autism-biomed newsgroups and learning about the Geiers’ testosterone-mercury hypothesis, a California father considered adding Lupron to the rapidly-expanding list of nutritional and pharmaceutical “interventions” he was administering to his 3-1/2 year old autistic son. The boy was under the care of several doctors, one of them a member of the DAN! (Defeat Autism Now!) network.

We are seeing DAN tomorrow and I will ask for a testo test. If it turns up normal I will not pursue. If it comes out way too high, I will probably try looking for something less drastic first […] I am praying that I will stumble onto something that will help. I know there are some things that are too good to be true. If Lupron is the magic bullet, though, I will first be sure and contact other parents and hear their experiences… My autistic boy is pretty macho if you dig. I don’t think it would hurt him any to reduce testosterone a bit, especially as he’s not even 4 years old yet. (March 15, 2006)

The father revealed that not only was he considering Lupron and chelation for removal of “heavy metals”; he also planned to administer high doses of Vitamin A to his son, “for measles.” He announced his determination to obtain testosterone labwork, even if his son’s DAN! doctor were to conclude that such testing was unnecessary. Eventually, he reported that the doctor ordered the test, even though he did not know how to evaluate the results, even though he was not yet familiar with Dr. and Mr. Geier’s hypotheses or treatment protocol, and even though the boy apparently displayed no signs of premature physical development.

We just got our package w/ the Vit A for the megadose for measles thing. And today we will see the DAN to get blood drawn (if necessary) for the testo test. If he doesn’t do it I’m going the ALA and direct labs way (as what else is he useful for?). (March 16, 2006)
The DAN doc was cool he said yes to the testo test… He wanted me to study Bradstreet and IV chelation and I asked him to check out the Geier’s and Lupron. I need to find a good link because he asked for a study and I only know about the videos. He wants to know more about what testo levels are abnormal, and what is the protocol (for him protocol is very detailed, not just a generality term the way we use it). (March 19, 2006)

The results of the testosterone test arrived, and the father turned for advice to his listmates.

Where do I go to figure out what is normal for my kid? I mean, the testo test came back and the ranges were for 21 and up, as if it is a diagnostic intended for older male fertility problem dx. S[…] got a score of 21.1 ng/dL. Whatever that means. (April 3, 2006)

Erik Nanstiel, Mark and David Geier’s de facto online publicist, offered his opinions on the test results, provided contact information, and assured the father that their evaluation could be conducted long-distance. An appointment was then made.

For a boy of 7 or 8, anything over 11 ng/dcl could be considered a marker for early puberty, and is high. I saw the medline data for lupron, and it’s used to treat boys with precocious puberty if they’re of this age and have levels anywhere between 11 and 30. A level of 21 is clearly too high, if that thumbnail of your boy is current and I“m guessing his age correctly… The Geiers can have him tested long distance. […] I can give you their office number. If you like… (April 5, 2006)
We have a phone consult w/ Dr. Mark Geier and David Geier for the 17th. I am actually glad they have extensive testing for candidacy. I’d be worried if they take anyone and run them through as a production line. (April 6, 2006)

The father described his telephone consultation with Dr. Geier, who reportedly informed him that his son’s testosterone level was abnormally high, and claimed that the “Lupron protocol” had yielded “good results” in 100% of over 100 patients who had tried it.

According to the phone conversation with Mark Geier this morning, 21.12 ng/dl is approx 4x normal for his age and gender. Mark Geier told me that he’s seen over 100 autistics, and all without exception have had good results. He said some within hours (of Lupron). (April 17-18, 2006)

Two weeks later, orders for extensive testing arrived in the mail, sent directly to the family. The father assumed that the testing and regimen would be expensive, but was not clear about its potential total cost.

[W]e finally got the test scripts from the Geier’s office. Lots of tests. Even genetics tests, which we’ve never done. Will have to bribe S[…] with toys to hold still for needles. (May 4, 2006)
Yes if testosterone tests high, and all other factors are counted out (tumor, genetics, etc), then lupron. As long as we still have money, that is. I understand it’s rather costly. […] Like time to take out a 4th mortgage kind of expensive. OK maybe not that bad. (May 9, 2006)

Although the father did not indicate how many needles his 3-1/2 year old son sat still for during his first session of blood draws, he reported that 4-1/2 vials of blood were taken on a subsequent visit — that is, an amount more than twice the maximum amount of blood that should be drawn at any one time from any child weighing under forty pounds. The father brought his son in for a physical examination by a pediatric neurologist, who saw nothing unusual in his lab results or during the examination, but nonetheless ordered additional tests. Presumably, separate vials of blood were collected from the boy for these.

S[…] got a bunch more blood, 4 1/2 vials. The mainstream pediatric neurologist said he doesn’t think 21 ng/dl is high for a 3 1/2 yr old boy. He asked whether S[…] is getting speech therapy and such. Looked at his testicles and said maybe the testosterone excess is coming from his adrenals. So he’s testing for other stuff (DHEA or whatever I guess it is that makes your hair fall out). (May 13, 2006)

Three different testosterone tests were ordered by three different doctors from three different laboratories — the Geiers from LabCorp, the DAN! doctor from his own “Institute for Progressive Medicine,” and the “mainstream” doctor from Quest Diagnostics. Presumably, separate vials of blood were collected from the boy for each. The varying results tend to confirm the observations of endocrine researchers who have decried the lack of standardisation and frequent unreliability of automated testosterone assays, especially in the evaluation of samples from women and children.

We’ve had 3 testosterone tests done. One was DAN! doc office “Institute for Progressive Medicine” (or undisclosed?), one was LabCorp, one was Quest. Our boy tested very high with the DAN! doc’s lab, but came back as normal according to Quest and LabCorp. Quest was the least helpful inasfar as the result was simply given as “<20 NG/DL”, and there was no reference range given (“Not Established”). According to some folks, my 4 yr old boy’s level should be no more than 3.5 NG/DL. (May 30, 2006)

The father ultimately summarized the results of various tests to which his son had been subjected. The boy’s DAN! doctor (who advertises “antifungal pharmaceuticals and nutriceuticals” on the Autism Research Institute website) found “lots of yeast,” and prescribed an antifungal medication.

1. It began with the DAN Doc recent tests. Kryptopyrrole test found within range. Did test for pathogens and found lots of yeast, with some Strep and Pseudomonas not far behind. He was absolutely void of Bifido (a good bacteria). S[…] is now on Nystatin.

A pediatric gastroenterologist had performed a colonoscopy on the boy; the findings were normal. Presumably, the boy underwent purging prior to the procedure, and sedation during it.

2. The ped-GI scoped S[…] and found nothing notable. He took a couple biopsies but I don’t know what he will test for. We had this done because even though we’ve improved S[…]‘s BM habit with butyrate supplementation, he continues to have slight blood after each BM.

The endocrine tests ordered by the “mainstream” doctor yielded results within normal range; the father seemed dissatisfied by this.

3. The mainstream ped-Endocrinologist thought 21 ng/dL was not high. He did fuller tests on S[…] (using Quest Diagnostics). Those test results came back with a lot of stuff that didn’t seem notable, he came within range for LH, T-4 Free, FSH, DHEA Sulfate. For testosterone he came in at “<20 ng/dL”, with the reference range left blank. The doc later said that was normal. Seemed a little vague to me. This doc has a good reputation among the mainstream peds, so I am scratching my head. However S[…] tested at double the ref max for “17-Hydroxyprogesterone LC/MS/MS” for his age group.

Creatinine levels were low, a result that did not differ from numerous previous readings. Presumably, blood was drawn for each of the previous creatinine tests, as well as for the current one.

Also these tests included CBC showing low creatinine. This is consistent with all 5-6 tests for creatinine in the past… From there someone suggested testing for high magnesium in the urine.

The father then reported that Dr. Geier had not only ordered tests for his autistic son — he had also ordered tests for his daughter, “for comparison” — that is, for research rather than out of medical necessity.

4. Dr Geier had S[…] and I[…] (for comparison) do a very wide array of tests. We are still waiting for the genetics test results.

When the results arrived, Dr. Geier reportedly stated that the boy’s normal testosterone level was atypical for an autistic child, and also suggested that the boy might have organic acidemia — an inherited condition that can be life-threatening without proper diagnosis and treatment.

Mark Geier verbally over the phone gave some test result recently. Geier said S[…]‘s testosterone came in normal also for his tests (via LabCorp). He said not only was this not typical of other autistics he’s tested, he also said the following other results were not typical, and in fact disturbing. Over the limit on lead. Extremely elevated plasma amino acids, especially alanine, glutamine, glycine and taurine. We may stop giving DMG until further notice. He said the test results suggested possible organic acidemia, hyperammonia and/or lactic acid issues (ie. inborn errors of metabolism). He has filled out further test requisitions.

Dr. Geier reportedly decided that the boy was not an appropriate “candidate” for Lupron or his study. Although he had not physically examined the child, he nonetheless requested further testing. The consultation then shifted to porphyrins, the immune system, metals, and gluten-free diet — the last recommended even if the boy did not appear to need it.

He found porphorin very high, another indicator of heavy metals burden. He also found S[…] very high in IgG to antigliadin. He said we have to get more religious about removing gluten, and that it is hurting him, even if we don’t clinically see it. Geier also said Chromium and Nickel were high. […] [I]t looks like lupron is not, at least for now, applicable for S[…]. (June 3, 2006)

The father later revealed that the results and interpretations of his son’s and daughter’s tests were communicated to him over the telephone not by Dr. Mark Geier, but by David Geier — a young man with no medical or nursing education.

The doc (Geier) didn’t say to chelate or not. I haven’t really spoken with him. Just his son called. (June 6, 2006)

Too late, the father learned the cost of his children’s eligibility assessment.

Unfortunately these tests are expensive. I think all the tests are going to come to around $10K. We got I[…]‘s comparison tests bill from LabCorp and it alone was over $3K. That we have to pay because our insurance doesn’t deal with LabCorp, they only do Quest. I’ll have to seriously cash in some nest egg here. (June 6, 2006)
Make sure you get your insurance on board. We didn’t. We forgot to ask how much. Labcorp didn’t tell us how much. Until we got the bill. For one kid, right around 7 grand. No new truck this year. (July 4, 2006)

It is evident that this father was unaware of the potential extent of his financial liability for screening for his children’s participation in research. If valid consent was obtained, the father would not have been dismayed when the lab bill arrived. A father’s zeal to try an experimental treatment on his children does not negate investigators’ obligation to fully and accurately disclose the risks and costs of participation in research. The involvement of distant commercial laboratories in the collection of blood samples does not exempt investigators from complying with standards for pediatric blood draws in the implementation of research. Even more than protecting parents from financial risk, fulfillment of these obligations would have offered some measure of protection to the actual research subjects — in this instance, two California preschoolers.

The Bottom Line

In his June 23, 2006 interview on the talk show Radio Liberty, Dr. Mark Geier offered an estimate of the number of children whose parents have submitted them to screening for his Lupron study:

And now we have several papers that have been accepted in about… We’re going to publish a whole series of papers because every child that we look at we do a complete medical work up… [W]e actually have worked up about 150 kids now with a complete genetic workup.

If this claim is accurate, the estimated retail cost of LabCorp tests for Dr. and Mr. Geier’s patient-subjects exceeds $1,500,000. This figure does not include tests from laboratories other than LabCorp; any CT scans, MRI, ultrasound or x-rays that might have been performed; the drugs administered to those children who “qualify for Lupron”; or consultation fees charged to the subjects’ parents. In medicine, a distinction exists between research and therapy. Costs for data-gathering should be borne by investigators and their institutions, rather than shifted to research subjects. In the case of the Geiers’ study, copious blood draws enable the rapid accumulation of research data at the expense of exposing children to unjustifiable risk; investigational assays of dubious medical necessity or clinical usefulness are ordered subsequent to long-distance telephone conversations with parents, then described as “outpatient care”; and third-party reimbursement — from private insurers and possibly from Medicaid — provides a convenient means of financing data collection. Absent such reimbursement, subjects’ parents have served as the Geiers’ research financiers — poor recompense for their altruism and their children’s discomfort.

By asserting that their study was approved by the “Institutional Review Board of the Institute for Chronic Illnesses” (discussed in a previous article in this series), Dr. and Mr. Geier represent that their project design and implementation conforms to widely-accepted ethical principles for the treatment of human subjects in research. Review of their methods suggests otherwise. Given the Geiers’ promise to produce a cascade of new scientific journal articles, and in view of their self-supervised IRB’s demonstrable unfamiliarity with their obligations for protection of human subjects, editors and peer reviewers would do well to scrutinize their manuscripts carefully, ask challenging questions about their scientific and ethical foundations, and recognize that these articles will inevitably be used to influence medical decisions parents make for their children — mindful that every data point is drawn from the blood of an autistic child.

to Part Ten:
TAP’s Connection

Comments


  1. “Costs for data-gathering should be borne by investigators and their institutions, rather than shifted to research subjects.”

    Right there should be the big fat red flag that this is quackery, and why it doesn’t register with the true believers I have no idea.

    — anonimouse    2006-08-25 15:19    #

  2. I’ve written some informed consent forms, and reviewd many more. Real IRB’s insist that the reqired procedures, including an estimate of how much blood will be drawn must be spelled out in the consent. Since there is no real IRB in this case, the subjects parents appear to be surprised at what is involved. Also, informed consent documents spell out financial obligations -- what is covered by insurance, what is covered by investigators and what costs the patient may be liable for. Real researchers who have a clue what may happen with an experiental treatment give warnings of side effects and adverse events that may occur. I think these parents are being sold a rosy picture, but don’t seem as pissed at the Geiers as they should be for the waste of resources and the pain and suffering their kids endured.

    — Ruth    2006-08-25 15:59    #

  3. That’s an awful lot of blood and money!

    — notmercury    2006-08-25 16:05    #

  4. The poor kids. All of this pain, for what? So the parents can cry over how much money it costs to “heal” an autistic child made that way by vaccines?? So the autistic child’s siblings can whine about how all the money got spent on the autistic kid? There’s plenty of that going around in the lay media.

    — Ms Clark    2006-08-25 16:14    #

  5. “Right there should be the big fat red flag that this is quackery, and why it doesn’t register with the true believers I have no idea.”

    Maybe the flag is so big, and the participants so close, that they can’t tell that it is even a flag at all. All they see is red – maybe in their checkbooks, maybe leaving in little vacutainers.

    — Do'C    2006-08-25 18:48    #

  6. I hate having blood drawn. It makes me feel sick. This article made me feel much sicker, for the duped parents, and especially for those poor children. This must be stopped.

    — Jennifer    2006-08-25 19:05    #

  7. Big evil pharma at least pays for the medicine and tests for patients in their studies-no $10,000 bill for most clinical trials. Of course we all pay indirectly in the cost of marketed drugs, but what business gives stuff away free?

    After getting all that blood drawn, these kids are probably docile as they are too weak to misbehave. Is that seen as improvement?

    — Ruth    2006-08-25 20:38    #

  8. dude. his “Endocrinologist was scratching his head”???

    what the hell is that? ans: a snide aside in an attempt to give the speaker a good reason to submit his/her child to biomedical experimentation.

    Vitamin A megadoses? No metabolic evidence of precocious puberty so they do some x-ray?

    Who the hell are these people?

    Start with plants. Then graduate to pets. Then, and only then move onto kids.

    — Bartholomew Cubbins    2006-08-25 22:59    #

  9. Curiouser and curiouser.
    I personally don’t mind blood draws and donate blood when I can.
    However, I just left a comment on AD’s blog about a similar (though in a tiny way) experience with requests for blood from a small boy. Not all doctors will insist on taking an unsafe amount of blood from a small child. I’m glad we have the doctors that we do. Looking at the amounts of blood requested by the Geiers and the cost of the tests, it blows me away.
    Great post Kathleen—can’t wait for the next installment!

    — Soapbox mom    2006-08-26 08:37    #

  10. The other thing about this sort of behaviour is that it then reflects back onto ‘mainstream’ practice. Here in the UK there are parents demanding to know why the NHS isn’t doing these 101 blood tests on their children (in comparison with the USA I think that the UK isn’t so keen on ‘in-depth’ screening to start with – not suggesting one side or the other is right, just noting). People like the Geiers are doing all this ‘busy work’ to look like they’re doing things, parents talk about them, even in the vaguest terms and spread a feeling that “if my doctor hasn’t done X amount of blood tests on my child then they aren’t doing their job properly”.
    Thank you for all the work you’re putting into this.

    — M    2006-08-26 14:11    #

  11. Every time I read one of this series I think, “That is it. It cannot get any worse than that.” Then you write a new episode and it keeps on getting worse. Those poor children. When the day of reckoning comes for the Geiers it will be largely due to your efforts. Thank you.

    — mike stanton    2006-08-27 05:23    #

  12. I have alwqays had great difficulty giving blood for a sample. My kids seem to have inherited it. Our veins see the needle coming and jump out of the way.

    Because of this, we have always insisted that blood be drawn when only absolutely necessary. even with that, my younger son does not look forward to a visit to the doctor unless I assure him that no blood will be drawn.

    These kids will hate doctors even more. Wait until they grow up and get a clue as to what their parents did.

    — TheProbe    2006-08-27 11:22    #

  13. Who said bloodletting was a thing of the past?

    Hey, maybe the Geiers are vampires and they’ve found a way to get rich and eat well at the same time.

    David could pass for a vampire.

    — clone3g    2006-08-27 16:50    #

  14. Just thinking that the only way the US government could touch Al Capone was to use the powers of the IRS. Since Geier, Pere et Fils seem to have judged to a nicety the multiple gaps in oversight of medical practice and pactitioners, perhaps the only way to sink their boat is to invoke the power of insurance companies. This must be costing them megabucks.

    Heartfelt thanks to you Kathleen for this work.

    — Alyric    2006-08-27 17:30    #

  15. Thank you, thank you, thank you. I just read a synopsis of the Geier’s claims on the Shafer Report, and was so appalled, I went online and found your rich website. What a service – and I thank you.
    Kathy Small

    — Kathy    2007-04-09 01:11    #

  16. I would assume that the heavy metals panel would at least be testing for total mercury…though the Geiers seem to go back and forth on whether they think organomercury is actually the problem.

    It really seems that they figure they can make difficult kids more docile by chemical castration.

    This is a fabulous series, great work.

    — Tlazolteotl    2007-05-30 16:52    #