A Dubious Diagnosis · 2006-06-25 19:30


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

In their short-lived article in Hormone Research, A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders, Mark and David Geier did not discuss in detail the scientifically unproven autism causation hypothesis upon which their interpretations of metabolic function in autistic children were based, nor did they discuss any pharmacotherapy administered to their young research subjects; rather, discussion was limited to the analysis of the children’s laboratory test results. Partial, sequentially published descriptions of data from a single study might serve to augment the authors’ publication records; this is a practice known as “salami publication”. However, for studies involving a small population, or with overlapping results, it is generally preferable to publish those results in a single paper, and thereby enable readers to become fully informed about the work under discussion.

With respect to the study currently being conducted by the Geiers, the scientific community, parents of autistic children, and autistic individuals themselves deserve full disclosure of its scientific justification and potential risks. A full description of the “Lupron protocol” should raise concerns at least as significant as David Geier’s inaccurate institutional affiliation in the article, or the retrospective approval of the Geiers’ research design by an Institutional Review Board situated in their suburban home, comprised of immediate family members, business associates, and at least one parent of a research subject, between them not possessing

“the professional competence necessary to review specific research activities, […] to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice”

— to say nothing of expertise in pediatric endocrinology.

Since the Geiers first published their hypothesis that elevated levels of testosterone increase the toxicity of mercury, filed an application to patent a diagnostic and treatment regimen based upon that hypothesis, and began to publicize it at public lectures and conferences frequented by parents and medical professionals, Internet forums focused on biomedical treatments for autism have been abuzz with discussion of the “Lupron protocol.” Reported numbers of autistic children prescribed and administered Lupron in conjunction with chelation have risen steadily over the past year and a half.

At the time I spoke to him [at the 2005 Autism One conference] he only had 3 children on the protocol, but I’m sure more have started since. (June 29, 2005)
We just started the protocol. As of a few days ago, there were about 12 kids on it. (August 2, 2005)
At the DAN conference the Geiers told me they had used it so far on 33 children. (April 17, 2006)
After working with 50 patients on this protocol, they’ve gotten a very good picture of how it should be dosed on a case-by-case basis. (May 23, 2006)

This steep increase over a brief period of time presents a statistical anomaly. Central precocious puberty (CPP) is the only pediatric condition for which sufficient evidence of safety and efficacy of Lupron exists to support FDA approval. With an estimated prevalence rate of 1:5,000 to 1:10,000 — 90% of whom are female — CPP is rare enough that a European endocrinological research consortium found it necessary to pool data from The Netherlands, Italy and France in order to accumulate 26 male subjects for a study of the effect of gonadotropin-releasing hormone agonist treatment on height.

In contrast, since November 2004, Dr. Geier — whose only board certification is in genetic counseling — is reported to have proferred or recommended numerous diagnoses of precocious puberty to autistic children, who, according to current autism incidence figures, represent a 1:166 minority of the total population, approximately 80% of whom are male. Even Dr. Geier’s potential pool of patients constitutes a minority of a minority, since it would logically include only children of those parents who attribute their children’s autism to mercury toxicity.

In identifying so many autistic children supposedly experiencing precocious puberty, and supposedly in need of Lupron, Dr. Geier may have benefited from an embarrassment of pathological riches sufficient to justify the claim of his son — a young man with no medical expertise — that precocious puberty

…is something that’s very, very common. (May 27, 2005)
…a very large number of autistics have these problems… this is something that’s ubiquitous. (May 26, 2006)

[Audio quotes are excerpted from original conference recordings.]

It is more likely, however, that the Geiers have benefited from employing in their research a diagnostic process that is far less rigorous than that practiced by board-certified endocrinologists.

At the end of his 2005 Autism One conference presentation, Mark Geier made it clear that by rendering diagnoses of “precocious puberty” to prospective candidates for the “Lupron protocol,” he sought to be free of criticism from “mainline medicine” — that is, criticism from medical professionals who adhere to generally-accepted standards of care — and reassured those who might be concerned that Lupron had not been demonstrated to be safe and effective for the treatment of children outside its labeled indication for central precocious puberty.

And just a last comment so that nobody misunderstands. We believe this therapy will work for most children who are mercury-toxic, whether or not — girls or boys — whether or not they are really in precocious puberty or not. We chose to work with precocious puberty because that puts us in mainline medicine. You can’t criticize using Lupron for precocious puberty; we believe it’ll work for most people. We believe that measuring testosterone is interesting, but since the test doesn’t work, it really doesn’t give you a level, and the girls that have autism in several studies have shown to have high testosterone as well, and high precocious puberty levels and we think, we haven’t done a girl yet, but we’re planning to do some girls as well. (May 27, 2005) [sound drop occurs on original recording]

One year later, in his 2006 Autism One presentation, David Geier described a “novel” diagnostic interview in which parents were asked to report “signs of premature puberty” in their children, and offered examples of supposed behavioral and physical indicators of the condition.

This is an area that’s very novel. We’ve now asked an awful lot of patients, and it’s something that mainline physicians and other doctors aren’t asking, which is, we asked for these patients, “do your children have signs of premature puberty?” And a fair number answered, “Yes.” And then we start talking in our interview, asking for specific questions. And these are things that if your child is, say, under eleven or ten, if they are showing early sexual changes, meaning masturbation behaviors, they’re showing aggressive behaviors, hair on their legs, mustache growing in, all of these things, growth spurt — these are things that are not normal. (May 26, 2006)

Mr. Geier displayed a lengthy list of lab tests [at right] involved in screening potential candidates for the Lupron study, and reassurred attendees that a child need display only one elevated lab result to be considered for participation.

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. (May 26, 2006)

During the question and answer session, a pediatrician asked about the viability of the “Lupron protocol” as a clinical tool for the treatment of “any kid in general,” particularly girls, teenagers, and autistic children who did not display all of the symptoms associated with a diagnosis of precocious puberty. Mr. Geier responded,

As far as that list, you don’t have to have all of those, those are the sort of what — the areas we’re looking at, as I said, we’re looking at one or more of those usually is what we’re looking at, for at least a candidate, so it’s not that restrictive. (May 26, 2006)

In spite of Mr. Geier’s assertions, precocious puberty cannot be diagnosed in the absence of grossly premature physical development; endocrinologists do not generally test for the condition unless physical symptoms are present. In boys, these include genital development before 9 years of age; in girls, breast development before 8 years of age. Biological findings (such as elevated luteinizing hormone in response to gonadotropin-releasing hormone, elevated testosterone or elevated estradiol) are used to confirm a diagnosis based upon evaluation of physical symptoms, not behavioral ones.

“Working with” a diagnosis of precocious puberty to justify prescriptions for Lupron administered in conjunction with chelation may serve to temporarily insulate Dr. Geier and Mr. Geier from criticism from “mainline medicine.” A diagnostic interview in which parents are encouraged to regard common behaviors with a wide range of possible causes, such as aggression and masturbation, as indicative of a rare condition, may enable parents to be persuaded to consent to pharmaceutical treatment of their children for a nonexistent problem. A diagnostic process that is “not that restrictive” may enable parents of autistic children who might not meet criteria for CPP according to professional practice guidelines to “try out” Lupron on their children, and acquire the drug without incurring substantial out-of-pocket expenses; it may also facilitate recruitment of subjects for the Geiers’ research, and minimize their costs in conducting it.

Participants in online autism forums have repeatedly implied that a precocious puberty diagnosis is essentially a formality required to obtain reimbursement for Lupron; that their children’s supposed “mercury toxicity” is the real problem they and the Geiers seek to address with the “Lupron protocol.”

I spoke with Dr. Mark Geier briefly, recently. Testosterone can be measured with blood SSH & LH levels. I don’t know how expensive this is. He did say, however, that abnormal enough levels would qualify your child for the dx of “precocious puberty” (premature puberty) which should make the treatment covered by most insurance policies. Apparently, the key is to use the appropriate testosterone reference ranges (i.e. for the sex and age groups in question). (February 4, 2005)
[T]he labs, according to the Geiers are ONLY an attempt to determine CPP and get insurance coverage for Lupron Depot. (June 4, 2005)
From what I’ve heard, neither an endocrinologist nor an MRI are mandatory (unless this is being referred to as helpful, in general, for diagnosis or insurance purposes). (June 5, 2005)
While many of these kids exhibit with clear signs of precocious puberty… that as a diagnosis is less important than that of high testosterone. As I said, girls with high testosterone and low estrogen won’t technically BE in early puberty. They’re just extremely difficult to chelate. My daughter has plataeaued or we wouldn’t feel the need to do this. (March 2, 2006)
We have seen Dr. Mark Geier and his son David who have ran a gamut of test on our son! One being the testosterone! Our son’s testosterone level was at the range of a 14 to 17 year old young man! Our son is only 5 years old! We have started this week on Lupron injections that will lower the testosterone levels and then we are starting tomorrow oral DMSA to help with detoxifying all these metals that are in him! […] We are excited about this… our son has been considered to have precocious puberty with these high levels and the BC/BS are paying for majority of the drug but the copay! Otherwise it would cost us approximately $7000 for the total script amount!!!! (March 2, 2006)
If you suspect that your boy behaves (self play) or appears more mature (hairy) than he should, then you need to tell your doctor that you suspect “precocious puberty”. He will test for high testosterone and other things. Note that autistic kids do not really have precocious puberty but it may be testosterone-mercury sheets bound. (May 19, 2006)
My son’s Lupron Depot was $1538.00 pre shot, given every 30 days. Dr Geier did the shots on my son since my insurance would only cover them if they were done in a doctor’s office. My Carefirst PPO did cover it but it was a real fight. (March 21, 2006)
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)

Parents have described diagnoses of precocious puberty that have been made of children beyond the age for such a diagnosis (< 9 years). One indicated that her son’s treatment with Lupron was started prematurely, and that his diagnosis turned out to be inaccurate.

We are starting Geiers protocol this month. My son is nine with a bone age of 12.8 (from hand x-ray). His FSH and LH were in normal range!!!!???? (May 8, 2005)
My son’s testosterone was high when tested but when we did a bone age test it showed he was actually underdeveloped for his age by a year or 2 — he did not have precocious puberty. We tried the protocol before getting results to the bone test and it did not help my son. We stopped since it would be dangerous to stop testosterone if your child does not have precocious puberty. (January 6, 2006)
We worked with the Geiers when my son did their protocol. I think that the first few patients were diagnosed with precocious puberty. My son’s testosterone levels were as high as these kids but he didn’t have the other signs of precocious puberty that they had. He did have a lt of aggression so we decided to try it. We gave it a 2 month trial but my DAN [Defeat Autism Now! doctor] and I did not think it was healthy to stop testosterone on an 8 yr old boy that is not having prec. puberty. Also, we did not see any changes in behavior or chelation output. (January 4, 2006)
My son is also on their protocal and doing very well. He is non verbal, No language, and both at home and at school we are hearing him say some words very clearly. He has only been on the protocal for one month and he is also almost 15 years old. (June 2, 2006)
Testosterone doesn’t cause puberty in a girl… Estrogen does, but my daughter had NO estrogen (nondetectable levels). She had enough testosterone that would have been normal for a 15 year old boy. So while she technically did not have early puberty… she should NOT have that much testosterone. (June 24, 2006)
Our DAN has a son who also is a Dr G protocol patient. And it is working for him too. He is 13 BTW and past puberty. (June 12, 2006)

Parents have described circuitous, irregular, piecemeal processes of obtaining diagnoses and medications for the “Lupron Protocol.”

I’m doing the protocol. Tell your hubby that my son did not have hair or a very brown scrotum and he was rx’ed. My son is 9 and 5’ 1”. His bone age was 12.9. Get an Endocrinologist to do the tests to prove precocious puberty. Get the rx. for Lupron. and get your reg. pediatrician to perform the monthly shots. Then thru your Dan doctor do the chelating. I learned this thru experience. You have to piece this together myself, but it is possible. This way the insurance pays for the Lupron and follow-up blood testing. Don’t even mention you are doing the chelating. Trust me. Your Dan Dr. will do the other needed testing. This process has taken me three months. I am soooo frustrated I could scream. (June 5, 2005)
I am sceptical that my DAN will do this test/treatment but I’ll try. As an alternative you can go to your kids pediatrician and tell him you suspect “Precocious Puberty” because of the reasons you mentioned. If the tests come out positive, then they will treat him. […] Just beware that the pediatrician might scare you and insist on a check-up for a brain tumor. Initially, all I want are test results — not yet sure as to the treatment. Lots of luck. (March 15, 2006)

Knowledgeable medical professionals and insurers might reasonably look askance at such scenarios. Although certain insurers such as Empire Blue Cross/Blue Shield cover clinical trial participation, those that do usually limit coverage to NIH trials or trials which the insurer has otherwise approved in advance. While routine costs of clinical trial participation may be covered, study drugs or devices are generally not covered; for example, both drugs and medical devices in clinical trials are explicitly excluded by Aetna, whose policy is modeled on the widely authoritative Medicare policy on coverage in clinical trials. Some policies will not pay for treatment of injuries sustained during research in which they did not approve the insured’s enrollment.

Families who fail to inform their health insurance carriers of clinical trial participation might find themselves in an awkward situation. If an insurance carrier wanted to recoup their losses for payments made in error for medically unnecessary treatment, they would be free to turn to either the physician or to the insured. In the case of Lupron, an insurer’s demand for repayment could total many thousands of dollars. For most families with developmentally disabled family members, either loss of insurance coverage or demand for repayment would be financially catastrophic.

to Part Four:
On Questionable Terms

Comments


  1. An amazing piece of work! I hope that soon these parents come to their senses before further damaging their chidren.

    — Jennifer    2006-06-25 20:11    #

  2. It just keeps getting better and better. No, worse and worse.

    — notmercury    2006-06-25 20:29    #

  3. Holy rare conditions Batman! Fascinating article Kathleen. I’m glad you brought up the issue of insurance coverage and clinical trials – parents need to understand the importance of checking this out prior to participating in research, in order to provide truly informed consent.

    “In contrast, since November 2004, Dr. Geier — whose only board certification is in genetic counseling”

    Apparently, a physician search at the American Board of Medical Specialties turns up zero “Mark Geiers”.

    It looks possible that the board he is apparently certified by (ABGC), may not be up to ABMS standards.

    — Dad Of Cameron    2006-06-25 20:39    #

  4. Shouldn’t the FDA be on top of this?

    Once again, great work Kathleen!

    — Joseph    2006-06-25 21:02    #

  5. Kathleen,

    You never cease to amaze me.

    Never.

    Well done!

    David

    — David N. Andrews BA-status, PgCertSpEd (pending)    2006-06-25 21:13    #

  6. Incredible. Both your investigation and what it's revealing.

    — Kev    2006-06-25 21:56    #

  7. This is getting scary.

    — Anne    2006-06-25 23:56    #

  8. And the Geier’s show that they are willing to bend over backward to play how-low-can-you-go ethics limbo.

    It would be great if the doctors and parents actively promoting this had to pay back the Lupron dough.

    The parents whose kids are harmed by this are going to need money to care for their harmed children. Lets hope the best for these poor kids who are being treated like lab rats.

    — Ms Clark    2006-06-26 00:15    #

  9. Great work. Among other things, I’m quite interested in the insurance scam. I’ve always thought that insurance companies have a pack of wolves who go out and rip apart those who are falsifying paperwork. It seems pretty clear to me that they’d have a field day with this nonsense.

    Where are the cops? Where are the insurance cops?

    — Bartholomew Cubbins    2006-06-26 07:25    #

  10. OK, lying about your affiliation and creating a phoney IRB are bad enough. But this is malpractise on children. I agree with BC. Where are the cops?

    — Mike Stanton    2006-06-26 12:11    #

  11. It just gets more astounding. Thanks, Kathleen. I’m still amazed that the parents who are up in arms over mercury are injecting this drug into their children against the manufacturer’s warnings for use and age. And, if you do the math on some of the doses that you read about, there must be some really hefty toddlers running around to warrant dosages that would be somewhere around the pre-teen weights or higher. Oh, and given daily or weekly instead of monthly. It makes me wonder if they even read the package insert. Wonder if we’ll see a whole new round of forums, special practioners and lawsuits to combat the Lupron conspiracy in a few years?

    I hope that you’re sending this information to every insurance company you can—I know I’m forwarding it to mine because I have no intention of subsidizing these quacks.

    — kimmah    2006-06-26 19:28    #

  12. What Kimmah said. ‘Big Pharma’ is evil when it suits them to be, your best friend when it suits them to be…

    — M    2006-06-27 09:37    #

  13. The AAPS is heavily wrapped up in the Schlafly family. Roger is a PhD engineer who specializes in bubbles. His brother, Andy, is the AAPS counsel. Mom, of course, is Phyllis.

    Apple…gravity…tree…no distance

    — TheProbe    2006-06-28 07:38    #

  14. What’s going to happen is that these parents will use Lupron on their kids and some of them will encounter health issues later in life. These parents will then become “Lupron parents” and start suing the manufacturer for putting out a dangerous product, holding rallies and creating websites like “generationlupron.org”.

    — anonimouse    2006-06-29 12:40    #

  15. Orac provides more commentary on this subject in his post, Anti-mercury Warriors Descending Further Into the Depths.

    — Kathleen Seidel    2006-06-30 07:24    #