Conduct Unbecoming a Reverend

Dear Bishop Kammerer

I note that the Women’s Division is hosting a conference on June 6 –7 2007 to address the issue of mercury poisoning through vaccines and that the Division has voted $5000 towards this project. I would imagine that the impetus for this educational effort comes from Reverend Lisa Sykes through her experience with her son’s autism, which she attributes to mercury in vaccines. It appears from your website that this issue is being framed as the traditional David versus Goliath, with the United Methodist Women’s Division firmly in the role of protecting the weak and the vulnerable from the machinations of powerful interests. Appearances can be deceptive.

Reverend Sykes is a fervent proponent of the “Lupron Protocol”, a means of treating autism in children by blocking the synthesis of steroid hormones, a form of chemical castration [1]. This theory is the invention of Dr Mark Geier and his son Mr David Geier, who have taken out a patent on the Protocol [2]. Reverend Sykes plays a prominent role as a member of the Institutional Review Board (IRB) overseeing the Protocol [3]. My purpose is not primarily to debunk this theory, but to point out that the deconstruction of this piece of pseudoscience necessarily casts the behaviour of Reverend Sykes in a very poor light. Her conduct in this enterprise appears to be incompatible with her calling.

I should emphasise that I am not impugning her motives. With no doubt the best of intentions, Reverend Sykes has spent considerable time touting this treatment at ‘alternative’ autism conferences and other venues.[4] Her faith in this remedy is such that she enrolled her son as one of the first patients for this novel treatment protocol. Her faith in the matter, however, is not informed by anything called scientific research or mainstream medical opinion.

The “Lupron Protocol’ rests squarely on three unsupported assumptions; that autism is a species of mercury poisoning through the past use of thimerosal preservative in vaccines and that mercury is trapped in the body by forming sheets with testosterone. Following from these assumptions, removing the mercury from the body (chelation) does not work because the high testosterone in autistic children (hyper-androgenicity and assumption three) effectively prevents its being removed, particularly from the brain. But, by lowering the level of testosterone through chemical castration (Lupron injections), chelation can do its job. There is no sound peer reviewed evidence that mercury in thimerosal at the levels given in vaccinations has ever harmed anyone or caused autism. A recent Daubert hearing at which Dr Mark Geier was the expert witness noted that:

It is also significant in the review of his methodology that Dr. Geier could not point to a single study that conclusively determined that any amount of mercury could cause the specific neurological disorder of autism. [5]

The Institute of Medicine of the American Academy of Sciences in their 2004 comprehensive review stated that there is no evidence of any link between autism and the mercury preservative thimerosal in vaccines [6]. The second pillar of this protocol, namely the claim of the Geiers that testosterone traps mercury in sheets, is fraudulent [7]. The reference they give refers to the preparation of a pure crystal for the purposes of crystallography. It has never been demonstrated that this reaction occurs in the body at 37 degrees Celsius, though it may occur if you first dissolve your autistic child in hot benzene. The third assertion that autistic children are inclined to hyperandrogenicity is at this point, an unsupported hypothesis. There is no cited evidence that they are and good evidence that they do not have higher testosterone levels than do other prepubescent children. A recent study from the National Institutes of Health concludes that:

Levels of adrenal hormones were not impressively different between the autism/ASD and control groups. This suggests that earlier sexual maturation is not the explanation for our results [8].

Given the shaky foundations for this Protocol, wise counsel would have questioned the immediate use of a powerful chemical castration drug, Lupron, on children, based on what is at best, a flimsy hypothesis. It is apparent that Reverend Sykes in her zealous pursuit of treatment for her son has been able to ignore far too many signs of dishonesty and blatant deception.

The most obvious of those and of greatest concern ethically is the composition of the IRB overseeing the Lupron Protocol [9]. This IRB is composed of three members of the Geier family, a business associate, a dental hygienist, a lawyer and the Reverend Lisa Sykes, whose son is one of the research subjects. The guidelines set down for an IRB are explicit:

Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members [10]

Contrary to those guidelines, there is no member with the requisite expertise in Biochemistry, Paediatrics or Endocrinology, the three fields that should be represented in hormone research in children. The rules covering the composition and function of IRBs, are there to impartially guide research and safeguard the human participants. That these rules have been flouted is obvious in that only two members of this IRB are eligible to vote to approve the research, the dental hygienist and the lawyer, and then only if they are clear of conflicts of interest. The others are barred because of their being family members, research participants or having a vested financial interest in the outcome. Reverend Sykes should be asked to explain her presence on an IRB, which, as constructed, cannot fulfil its legal and ethical obligations to its young experimental subjects.

There is a second irregularity with this IRB. Dr Mark and Mr David Geier published the preliminary results of their Protocol in an article in Hormone Research [11]. The article cites their IRB as having approved the research. However, it appears that the IRB was only established in March 2006 and the research that it was supposed to oversee took place between November 2004 and November 2005.

There are many irregularities in the administration of the Lupron Protocol, which could not have occurred if the IRB was a duly qualified body. The sole use of Lupron in children that is approved by the US regulator is for the rare condition of central precocious puberty. The insert for Lupron states that the diagnosis should include the following

2. Clinical diagnosis should be confirmed prior to initiation of therapy:

• Confirmation of diagnosis by a pubertal response to a GnRH stimulation test. The sensitivity and methodology of this assay must be understood [12]

The pre-testing of autistic children for the Protocol as carried out by the Geiers and meticulously documented by Kathleen Seidel [13] runs to between $ 7,000 to $10,000 and includes some esoteric genetic tests, which are currently experimental. It does not include a GnHR stimulation test. The test, which is crucial to the diagnosis of central precocious puberty and for the monitoring of treatment [14] is missing from the testing array of these autistic children. Incidentally, the usual work-up for central precocious puberty, which does include a GnHR stimulation test cost around $650 in 1999 [15].

As already stated, Lupron’s sole FDA approved use in children is for treating central precocious puberty. But, Dr Geier has ‘branched out’ as he put it and in his own words urged health insurance companies to pay for Lupron because it is also used to treat serial sex offenders.in the criminal justice system. Here is Dr Geier at the U.S. Autism and Asperger Association (USAAA) conference. [16]

what we’re trying to do is get rid of their aggressive behavior so the parents can keep them, because the state keeps saying they’re going to take them away. Now here, we’re not on new ground. The state does this a lot, and in fact, knock on wood, so far, I’ve gotten every health plan — we’ve got about eighty kids — we’ve gotten every health plan to pay for the Lupron. While on the fourteen-year old it was interesting. They said, “we can’t pay for the Lupron, he doesn’t have precocious puberty, he’s fourteen.” And I said, “I didn’t write he has precocious puberty, I wrote he has hyperandrogenemia, high testosterone.” And they said, “we never do that.” And I said, “Oh really? Don’t you have any eighteen to twenty year olds that the court orders —” “Oh yeah, once a month.”

Autistic children can be treated as sex offenders apparently. The branching out has also included major changes to the Lupron protocol that is recommended by the manufacturer. Some of these children are getting twice the recommended Lupron depot shots (given every 14 days instead of 28 days), plus daily sub-cutaneous Lupron shots plus Androcur, an androgen antagonist not FDA approved for children, because it has been largely replaced by Lupron.. But none of this is recommended for children nor could ever be recommended for children in any country, which has a functional child protection service. I would urge you very strongly to find a paediatric endocrinologist in your area and get his opinion on the ‘Lupron Protocol’ as practiced by the Geiers. [17]. You would have to add that none of the autistic children undergoing this drastic treatment has a diagnosis of central precocious puberty or hyper-androgenicity. The test that is crucial to that diagnosis, the GnRH stimulation test, has not been done.

Reverend Sykes has also acted in an editorial capacity for Dr and Mr Geier, who expressed their gratitude on page 5 of Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines. [18] That article consists of two parts. The second part is practically a verbatim plagiarisation of the draft manuscript by Verstraeten et al, titled Risk of neurologic and renal impairment associated with thimerosal-containing vaccines, which is in the public domain on the Safeminds website. [19] No special expertise is required to spot the gross similarities. Worse, Reverend Sykes is very familiar with the contents of the Verstraeten manuscript having cited it in her own work as an autism advocate. [20]

The link between autism and mercury in vaccines has been promoted by Dr Mark Geier and his son David in six articles based on the contents of two government databases, the Vaccine Adverse Events Reporting System (VAERS) database maintained by the CDC and the California Department of Disability Services (CDDS) database. Reverend Sykes and other zealots of a similar persuasion choose to ignore the warnings issued by the CDDS and the CDC about the limitations of these databases. The American Academy of Paediatrics wrote an article outlining in considerable detail the ways in which Dr and Mr Geier have misused the VAERS. [21] For a scholarly article it is just barely polite. The Geier’s interpretation of the CDDS data has been similarly exposed as a species of statistical malfeasance. [22] The organisers of the June event should be aware that the CDDS data, if interpreted correctly, continues to refute the notion that there is a link between autism and mercury in vaccines. Though mercury has been removed from the standard childhood vaccine regime for many years, the number of 3-5 year olds with autism continues to increase. [23]

In the ordinary course of events, I would have been loath to become involved in criticising a parent for her attempts to do the best by her child, even when I would have disagreed vehemently with her conclusions. That was certainly the case up to the point when Reverend Sykes started championing the Lupron Protocol and extolling the Geiers as bona fide researchers in the field of autism. There are two basic reasons why this is unacceptable. Primarily, a Christian minister is engaging in behaviour, which is potentially harmful to children, in direct violation of her sworn promise to look after the vulnerable. Professor Simon Baron Cohen of Cambridge University assessed the risks as follows.

I am aware that the Geiers are citing our work to justify their treatments involving lowering testosterone levels in autism. I have never advocated for this treatment, and indeed am opposed to such treatments on two grounds: ethical (manipulating hormones affects many systems in the body and mind, many of which do not stand in need of ‘treatment’) and safety (such treatments may carry risks, many of which are unquantified).[24]

Secondly it appears that this leader of a Christian community is perfectly capable of any amount of moral relativism in pursuit of a personal goal.

Of minor importance, the Reverend Sykes is disseminating, quite unconsciously along with her proselytizing of the Lupron Protocol, the notion that to be Christian is to be credulous. I look to the governance of the Uniting Methodist Church to bring one of its own back into the fold.

Sincerely

Background and References

1. A comprehensive review of the Lupron Protocol by Ms Kathleen Seidel can be seen here: [reference: http://tinyurl.co.uk/jyeo]

2. Patent application: [reference http://tinyurl.co.uk/akzr]

3. Membership of the IRB:[reference: http://www.neurodiversity.com/geier_irb.pdf]

4. The video presentation given by Reverend Sykes: [http://www.autismmedia.org/media4.html].

5. Transcript of a recent court case for which Dr Mark Geier was the principal expert witness. [http://www.neurodiversity.com/court/rhogam_decision.pdf]

6. IOM review: [http://newton.nap.edu/catalog/10997.html#toc].

7. Their theory that testosterone forms sheets is discussed in some detail here: [http://www.autismmedia.org/media4.html: Part 2)] The reference that they rest their theory on is here: [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=5756987&dopt=Abstract]. This is the method for preparing a mercury chloride compound of testosterone for crystallography, which combines equimolar amounts of testosterone and mercury chloride in hot benzene, not something that happens at body temperature.

8. The biochemical rationale that the Geiers use for their theory of hyperandrogenicity is that ASD children with low glutathione do not convert DHEA to DHEA-S and since alternate pathways are blocked, they convert their steroid precursors mostly into testosterone. The NIH study Elevated Levels Of Growth-Related Hormones In Autism And Autism Spectrum Disorder, J. L. Mills, M. L. Hediger, C. A. Molloy, G. P. Chrousos, P. Manning-Courtney, K. F. Yu, M. Brasington, L. J. England, casts considerable doubt on this hypothesis [http://www.cevs.ucdavis.edu/Cofred/Public/Aca/WebSec.cfm?confid=238&webid=1245]. The authors found that ASD children are in fact twice as likely as controls to have detectable DHEA-S. The innocent explanation for not producing DHEA-S is simply the prepubescent status of children.

9. IRB composition: [http://www.neurodiversity.com/geier_irb.pdf]

10. Guidelines for IRBs [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.107]

11. Geier, M, Geier D - A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders [http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ProduktNr=224036&Ausgabe=232055&ArtikelNr=94467].

12. Manufacturer’s directions: [http://www.fda.gov/medwatch/safety/2006/Feb_PI/Lupron_PI.pdf]

13. [http://www.neurodiversity.com/weblog/article/110/]

14. Margaret L. Lawson and Nini Cohen, A Single Sample Subcutaneous Luteinizing Hormone (LH)-Releasing Hormone (LHRH) Stimulation Test for Monitoring LH Suppression in Children with Central Precocious Puberty Receiving LHRH Agonists, The Journal of Clinical Endocrinology & Metabolism Vol. 84, No. 12 4536-4540 [http://jcem.endojournals.org/cgi/content/full/84/12/4536?ck=nck].

15. [http://www.aafp.org/afp/990700ap/209.html].

16. [reference: Kathleen Seidel: http://neurodiversity.com/weblog/article/114/pharmaceutical-cornucopia]

17. ibid.

18. [http://www.jpands.org/vol11no1/geier.pdf]

19. [http://safeminds.org/legislation/foia/VSD_VerstraetenJune2000.pdf].

20. [http://www.fda.gov/OHRMS/DOCKETS/dailys/04/nov04/111504/04p-0349-sup00001-vol1.pdf].

21. [http://www.aap.org/profed/thimaut-may03.htm]

22. [http://goodmath.blogspot.com/2006/03/math-slop-autism-and-mercury.html; and also here: http://interverbal.blogspot.com/2006/03/review-of-early-downward-trends-in_15.html]

23. There are multiple references on the web to the CDDS stats. This blogger does a very thorough analysis every quarter. http://autismnaturalvariation.blogspot.com/2007/01/hell-fails-to-freeze-over.html

24. A perwonal communication to Ms Seidel. http://neurodiversity.com/weblog/article/107/

email addresses for UMC

weitzel_chris@hotmail.com, EstellePruden@vaumc.org, cooperd@umumr.org, jwinkler@umc-gbcs.org, bmefford@umc-gbcs.org, newsdesk@umcom.org, judicialcouncil@umc.org