TAP's Connection · Aug 29, 03:00 PM


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

Saturday morning, during a chance visit to the website of the World Intellectual Property Organization, I discovered an application to patent the “Lupron Protocol” (full text in .pdf and HTML), its text largely identical to the application filed by Mark and David Geier with the U.S. Patent and Trademark office. Both applications were filed on September 13, 2005; both were published in March 2006 — the US application on March 15, and the WIPO application on March 30.

For all the similarities between the applications, two significant differences stood out. Whereas the US application seeks to assert ownership rights to the “Lupron Protocol” within the United States, the WIPO application seeks to assert those rights worldwide. Whereas the US Patent application named Mark and David Geier as sole applicants and inventors, the first-named applicant on the the WIPO patent application is TAP Pharmaceuticals, followed by the Geiers.

Like many pharmaceutical companies, TAP solicits ideas and inventions from independent developers. The joint TAP-Geier WIPO patent application indicates that Dr. and Mr. Geier have entered into a licensing or partnership agreement with TAP, in which the parties seek to assert joint ownership and share any profits that may accrue from the application of the “Lupron Protocol” in physicians’ medical practice. Although medical process patents are selectively and minimally enforceable in the United States, and although they are prohibited in most countries of the world, any such patent constitutes an asset. The value of a heretofore unenforceable patent could significantly increase subsequent to legal or regulatory changes.

Both the Geiers’ US patent application, and the joint TAP-Geier WIPO application, were prepared and submitted by Lisa V. Mueller of the Chicago law firm, Wood, Phillips, Katz, Clark and Mortimer, which counts among its clients TAP Pharmaceuticals and TAP’s parent company, Abbott Laboratories. At the very least, this indicates that Dr. and Mr. Geier have received legal assistance from TAP in the dissemination of the “Lupron Protocol” in both the US and worldwide markets. Whether they have received any research and development grants, speaker’s fees or other benefits from TAP remains to be discovered.

In October 2001, TAP was charged with conspiracy to commit violations of the Prescription Drug Marketing Act, specifically fraudulent pricing and marketing of Lupron. TAP agreed to pay $879,000,000 to resolve its liabilities; $290,000,000 of that amount represented the largest criminal fine ever imposed on a health care company. TAP’s settlement also included a Corporate Integrity Agreement, enforceable for seven years.

Today, I sent the following letter to Alan MacKenzie, President of TAP Pharmaceuticals.



29 August 2006

Dear Mr. MacKenzie,

I am mother to two teenagers, one diagnosed with an autistic spectrum condition, and have other family members with autistic spectrum diagnoses and traits. I am also proprietor of the website Neurodiversity.com, which contains over ten thousand links to resources about autism and related subjects.

Over the past few years, I have become deeply concerned about the extent to which speculation posing as science has been disseminated to parents of autistic children and the public at large. Misleading, inflammatory and biased information about autism is often promulgated by individuals supporting plaintiffs’ interests in pending thimerosal litigation, or promoting expensive, unproven “treatments” and “cures” such as chelation, dangerously high doses of vitamins, and off-label, experimental use of pharmaceuticals. In this context, my attention has been drawn repeatedly to the work of Mark and David Geier, who have generated numerous journal articles of dubious scientific quality alleging a causal connection between vaccine injury and autism.

Since early 2006, I have researched in-depth and written a series of articles about Dr. and Mr. Geier’s promotion of the “Lupron Protocol” — that is, the administration to autistic children of Lupron concurrent with chelation, on the premise that autism is caused by vaccine-induced, testosterone-enhanced mercury poisoning, and that reduction of testosterone levels in children might potentiate the action of chelation to remove mercury from the body and thereby (supposedly) cure autism. There is no credible, generally accepted medical or scientific evidence to justify such a practice. Dr. Geier has prescribed Lupron to children diagnosed with central precocious puberty according to inadequate criteria; his “eligibility” process enables children to be diagnosed with CPP who have no physical indications of accelerated physical development. These “less restrictive” diagnoses enable parents to obtain insurance reimbursement for Lupron prescribed to children who would probably not be given a CPP diagnosis by any reputable endocrinologist.

My most recent writings on this subject are collectively titled, Significant Misrepresentations: Mark Geier, David Geier and the Evolution of the Lupron Protocol. I urge you to read these articles in their entirety; they are extensively documented, and describe what I believe is a profoundly unethical, ongoing research endeavor.

In late February, I contacted TAP Pharmaceuticals to express my concerns, pointing out that neither Dr. nor Mr. Geier have any discernible expertise in the field of endocrinology, that the scientific justification for the “Lupron Protocol” was largely speculative, and that it would be in the best interests of autistic children and TAP Pharmaceuticals to steer clear of the Geiers. At that time, both TAP’s Director of Marketing, Rich Daly, and staff attorney George Kokkines assured me that although physicians are free to prescribe drugs for off-label uses, TAP did not support or promote the use of Lupron for the purposes I described.

A stance of non-involvement by TAP seemed prudent from a business and legal standpoint, given Mark and David Geier’s lack of relevant expertise. In a November 2004 deposition, Dr. Geier testified that he had never been involved in the care and treatment of autistic children or mercury poisoning until that week, and had no formal training in the field of toxicology, pharmacokinetics, or toxicokinetics; David Geier’s highest degree is a B.A. in Biology. Non-involvement seemed prudent, given the Geiers’ profession as legal consultants to plaintiffs in vaccine-injury cases — possibly including cases in which Abbott Laboratories was named as a defendant. Non-involvement also seemed prudent, given TAP’s obligation to honor both the Corporate Integrity Agreement detailing the terms of its 2001 settlement with the U.S. Attorney’s Office, and its promise to enforce its own Code of Business Conduct, which requires compliance “with all applicable laws and regulations, including the Prescription Drug Marketing Act, and all Company policies, procedures, rules and practices that govern research, development, manufacture, and distribution of foods, drugs, drug samples, medical devices or biological products” — a stipulation that gives cause for reticence in associating with independent researchers with a track record of trouble with at least one Institutional Review Board.

In March 2006, I discovered an application to patent the “Lupron Protocol,” submitted in September 2005 to the US Patent and Trademark Office, in which Dr. and Mr. Geier were named co-applicants and co-inventors. I forwarded links to the USPTO pages to Mr. Kokkines, pointing out that the patent application confirmed the impression conveyed in the Geiers’ public presentations — i.e., that their procedure for determining precocious puberty does not conform to generally-accepted standards of medical practice.

I have just learned to my great dismay that, contrary to Mr. Daly and Mr. Kokkines’ assurances, an application to the World Intellectual Property Organization to patent “Methods of treating disorders having a component of mercury toxicity” (WO/2006/033907) — that is, the “Lupron Protocol” — names TAP Pharmaceuticals as co-applicant with Mark and David Geier. The joint TAP-Geier WIPO application is virtually identical to the Geiers’ USPTO application; both were prepared and submitted by Lisa V. Mueller of Wood, Phillips, Katz, Clark and Mortimer. I understand that this firm represents both TAP Pharmaceuticals and Abbott Laboratories.

I would prefer to assume that neither Mr. Daly nor Mr. Kokkines were aware of TAP’s business relationship with Dr. and Mr. Geier at the time they spoke to me. I would tend to speculate that the “Lupron Protocol” proposal was discussed within TAP’s licensing division, then transformed into a patent by an intellectual property specialist, with no input from anyone on TAP’s scientific or medical staff, and no input from anyone familiar with the litigation-driven nature of much of the “science” cited in it. It is difficult to imagine that TAP’s management would knowingly validate the hypothesis of autism causation promulgated in the patent application, and even more difficult to imagine that anyone with the scientific expertise required to serve in pharmaceutical research and development would fail to scrutinize assertions such as:

“It is known in the art that mercuric chloride binds and forms a complex with testosterone in subjects … When testosterone binds with mercury a complex is formed. These testosterone-mercury chloride complexes are difficult to remove from the subject with a chelating agent… [A]s the testosterone-mercury complexes begin to break apart, there is the potential to release biologically active testosterone into the body. The result is that the released biologically active testosterone may interact at the cellular level with deposit of mercury within cells, and thus produce testosterone-mercury toxicity to such cells.” (pp. 1,31,32. These assertions are scientifically unfounded; the one study cited to support them grossly mischaracterized.)
“Recent studies have reported that exposure to mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autism, and the similarities extend to neuroanatomy, neurotransmitters, and biochemistry.” (p. 4. All citations supporting this assertion are to articles by non-scientists supportive of plaintiffs’ interests in thimerosal litigation; ; they have been ably refuted by researchers with demonstrable expertise in autism and toxicology.)
“It has been shown that children receiving thimerosal-containing childhood vaccines were 2- to 8-fold statistically significantly more likely to develop autistic and other neurodevelopmental disorders, depending upon the symptoms and outcomes examined, in comparison to children receiving thimerosal-free childhood vaccines.” (p. 8. All six citations supporting this assertion are articles by Mark and David Geier, written after they became involved in thimerosal litigation; they have been ably refuted by researchers with demonstrable expertise in autism and epidemiology.)
“The understanding of the cause of the epidemic has allowed for the design of treatment modalities that address the mercury toxic component of these disorders.” (p. 10. Although there has been an increase in numbers of autistic spectrum diagnoses, there is no scientific consensus that an “epidemic” of autism exists, or that autism is the consequence of iatrogenic, primarily vaccine-induced mercury poisoning.)
“Researchers have investigated prenatal testosterone levels in children with autistic spectrum disorders… The authors demonstrated that the more severely affected the children were the higher the levels of prenatal testosterone.” (p. 11. The research cited here has been demonstrably misrepresented; one of the principal investigators has publicly denounced the “Lupron Protocol” as scientifically and ethically suspect.)
“Sex steroid levels can be used to determine and diagnose whether a child is suffering from precocious puberty.” (p. 25. Measurement of sex steroid levels alone is insufficient to establish a diagnosis of precocious puberty.)
“The present inventors have found that the level of mercury in a subject can be lowered by treating a subject with a combination of a pharmaceutically effective amount of at least one luteinizing hormone releasing hormone composition and a pharmaceutically effective amount of at least one chelating agent and then by repeating this treatment until the level of mercury in said subjects has been lowered.” (p. 31. This and other statements like it, containing assertions of clinical findings, are not supported by any citations; the Geiers have not established that Lupron contributes to elimination of mercury.)
“The above method can not only be used to treat subject having a high level of mercury (and who suffers from mercury toxicity), but can also be used to treat diseases and disorders that have a mercury component. Such diseases and disorders include, but are not limited to, autism, autism spectrum disorders, attention deficit disorder, attention deficit hyperactivity disorder, mental retardation, Asperger’s syndrome, childhood psychoses, stammering, stuttering, tics, repetitive movements, eating disorders, sleep disorders, enuresis, developmental language disorders, developmental speech disorders, developmental delay, Alzheimer’s disease, diabetes, heart disease, obesity, amyotrophic lateral sclerosis, nephritic syndrome, renal failure, asthma, systemic lupus, autoimmune thyroiditis, rheumatoid arthritis, arthritis, vasculities, myelitis, glomerulonephritis, optic neuritis, infantile cerebral palsy, epilepsy, migraine, toxic encephalopathy, cerebral degenerations, anterior horn cell disease, spinocerebellar disease, extrapyramidal disease and myopathy.” (p. 32. It would seem the only human ailment without a “mercury component” is baldness.)
“[T]he inventors have found that children, particularly male children, who have a high level of serum testosterone have a greater risk of developing autism, particularly if these children are exposed to mercury, such as through food, vaccines containing mercury as a preservative, environmental pollution, etc.” (pp. 33-34. No citations are offered to substantiate these assertions about autism causation and susceptibility.)

TAP’s status as a co-applicant on this patent may well be construed as a corporate and/or scientific endorsement of the debatable autism causation hypothesis that is its basis, and is partially exemplified by the above quotes. Is this your intention? TAP’s status as a co-applicant on this patent may also be construed as an endorsement of Dr. and Mr. Geier’s research and treatment methods, which are questionable in the extreme. Does TAP condone their:

§ establishment of an Institutional Review Board (OHRP registration attached) controlled by Dr. Geier, its membership consisting of his family members, business associates, political allies, and parents of patients (including the mother of “Child X” described in the patent application)?
§ inaccurate representation of Mr. Geier’s institutional affiliation in a recent article describing elements of the “Lupron Protocol,” and failure to acknowledge their patent application as a potential conflict of interest?
§ utilization of nonstandard, “less restrictive” criteria to diagnose dozens of autistic children with central precocious puberty — even though many display no signs of accelerated physical development, and even though most are boys, in whom CPP rarely occurs?
§ promotion of the “Lupron Protocol” with claims that it can “make autism disappear”?
§ misrepresentation of research cited in support of their scientific claims, including alteration of a chart from a study by other researchers?
§ publication of an academic journal article in which extensive text and data are virtually identical to text and data from a study prepared by CDC personnel in 2001?
§ characterization of medically-unnecessary, investigational diagnostic tests as patient care, for which copious quantities of blood are drawn from children, and for which parents and insurance companies are billed?
§ administration of Lupron to children for extended periods of time, concurrent with mineral-depleting chelating agents (DMSA, EDTA and DMPS), absent any published research on the impact of such a combined regimen on bone mineral density, both during treatment and after?

When I originally communicated with Mr. Daly, I acknowledged that Lupron is a unique and powerful product with legitimate, well-defined uses for which evidence exists to demonstrate its safety and efficacy. These do not include “increasing the efficacy of chelation” or “reducing mercury toxicity,” no matter how many “less restrictive” diagnoses of central precocious puberty are conjured up to justify what is for all practical purposes an off-label use of Lupron. Please remember — the subjects described in the patent application are children who deserve our most resolute protection. I urge you to consider the moral and legal implications of supporting Mark and David Geier in their development and promotion of the “Lupron Protocol,” to disassociate from them, and to reject any research that does not hold the protection of autistic children in the highest regard.

Sincerely,

Kathleen Seidel
neurodiversity.com | honoring the variety of human wiring
http://www.neurodiversity.com

cc:
L. Stephan Vincze, Vice-President of Ethics and Compliance, TAP Pharmaceuticals
Rich Daly, Vice-President of Marketing and Commercial Strategy, TAP Pharmaceuticals
George Kokkines, Legal Division, TAP Pharmaceuticals
Laura J. Schumacher, Senior Vice-President, Secretary and General Counsel, Abbott Laboratories
Melissa Brotz, Divisional Vice President, External Communications, Abbott Laboratories
John Taylor, Divisional Vice President, Federal Government Affairs, Abbott Laboratories
Lewis Morris, Chief Counsel to the Inspector General, U.S. Department of Health and Human Services
Mary Riordan, Assistant Counsel to the Inspector General, U.S. Department of Health and Human Services
Jack Schwartz, Assistant Attorney General; Director, Health Policy Development, Maryland Attorney General’s Office

to Part Eleven:
The Pharmaceutical Cornucopia

Comments


  1. There’s not much that would have surprised me about the Geiers and their sordid schemes, but this certainly did. It’s almost enough to turn me into a true believer in the evils of Big Pharma conspiracies.

    Good job digging it up, Kathleen. With all the dirt you’re unearthing, you may have a hole half the way to China by the time you’re done.

    — Bonnie Ventura    Aug 29, 03:19 PM    #

  2. Aren’t Abbott/TAP the very personification of Big Pharma?

    I wonder what Monteith and Ayoub will think of them now?

    — Kev    Aug 29, 03:28 PM    #

  3. Oh, Now I get it. It’s all about Big Pharma conspiracies… it’s just that Big Pharma is conspiring WITH the mercury parents NOT against them!

    I wonder what “Radio Free Tinfoil Hats,” the “Judy Gibberding” sobbing spiritual leader, thinks of this. Isn’t the whole conspiracy thing that they are all pushing that Big Pharma causes disease with some drugs and then cures them with some more expensive ones? Abbott is part of the thimerosal manufacturers lawsuit thing, right? And now they are conniving with the Geiers to sell the much more expensive Lupron to cure the “thimerosal poisoning”? Makes perfect sense… except we need to check to see if Dr. Mark Geier can shape shift with that part reptilian DNA he must have. ... now we know why he must have gone into genetics…

    — Ms Clark    Aug 29, 03:31 PM    #

  4. I hope there are pressing commercial reasons for TAP to pull the plug on the Geiers. I do not believe they will act out of any moral compunction, unfortunately. :-(

    — mike stanton    Aug 29, 03:41 PM    #

  5. Let me get this straight. Of all the claims about this and that person being in the pockets of “Big Pharma”, we find that it is Geier & Geier who actually are in bed with “Big Pharma”. I hope you keep us posted on the response to your letter. Great work, as usual.

    — Joseph    Aug 29, 03:52 PM    #

  6. Ok, let’s see…

    Abbott marketed a DTaP-containing thimerosal vaccine. Thus, they are a target for upcoming litigation, which could theoretically cost them millions of dollars.

    Abbott’s subsidiary is now actively pursuing a business relationship with a couple of questionable scientists to cure a condition (thimerosal-induced autism) that they will likely testify in court does not exist.

    I’m not sure if that says more about Abbott or the Geiers, actually.

    — anonimouse    Aug 29, 05:12 PM    #

  7. TAP and the Geiers… what a whopping conflict of interest!

    They are positively bi-pharmaceutical.

    — TheProbe    Aug 29, 07:32 PM    #

  8. Thanks to y’all for visiting. This was quite a discovery. It’s all pretty ironic, isn’t it? I don’t have any bones to pick with Abbott; they’re a separate organization. As far as conspiracies go, I keep coming back to the saying, “Never attribute to malice that which can be adequately explained by stupidity.” I keep wondering — hoping — that this is the result of a massively short-sighted and poorly-informed decision by some folks in TAP’s licensing division who encountered what they thought was an opportunity to turn a profit for the company and went for it, not anticipating the scrutiny it would attract.

    — Kathleen Seidel    Aug 29, 09:29 PM    #

  9. Maybe I’ll call TAP up and propose that we go into business marketing Lupron as a cure for colic. I think they’d go for it. Why not?

    — TNI    Aug 29, 10:38 PM    #

  10. Hi Mike..

    “I do not believe they will act out of any moral compunction, unfortunately. :-(”

    Nor do I. But even if they do it purely on economic grounds, it’ll bugger the Geiers up anyway.

    About time those two were given a reality check.

    ‘Quack-quack!’ Mind the ducks…..

    — David N. Andrews BA-status, PgCertSpEd (pending)    Aug 30, 11:00 AM    #

  11. at least they’re not just in it for the money…

    they’re simply trying to protect their ground-breaking chemical idea of testosterone sheets!

    Actually, the whole sheet thing is really plagerism at its finest. A year before Laurel and Hardy came out with their N-rated (nanstiel) movie, The Half-Blood Prince told Harry to shove a bezoar down Ron’s throat if testosterone sheets were found because he was mercury poisoned.

    — Idea Protectionator    Aug 30, 01:00 PM    #

  12. Can Rashid Buttar patent the urine injections thing? He’s getting behind in the money making isn’t he? I think I’ll send him a donation, just to be FAIR.

    — 'nuther idea    Aug 30, 11:43 PM    #

  13. “Never attribute to malice that which can be adequately explained by stupidity.”

    However, if one willfully ignores the truth and pursues a line of research that could potentially be harmful to others, it ceases to be chalked up to “stupidity” any longer.

    I’ll give TAP a little bit of slack. The Geiers have to know better by now, after all this time.

    — anonimouse    Aug 31, 11:21 AM    #

  14. It’s been pointed out on Usenet that pharmaceutical companies have gotten in a lot of trouble (we’re talking about low-9-figure fines) for marketing their products for off-label use. I doubt that simply filing a patent application would count (after all, drug companies normally apply for and receive patents well before they get even basic approval), but TAP would in fact have to apply for and receive approval for the type of use described in the patent application if they wanted the patent to be worth anything to them. I doubt an arrangement where Mark Geier administered the “Lupron protocol” (it’s legal for doctors to prescribe drugs for off-label uses, with a few exceptions like human growth hormone) and paid royalties to TAP would pass muster.

    — ebohlman    Aug 31, 02:04 PM    #

  15. NI: “Can Rashid Buttar patent the urine injections thing?”

    I thought the phrase was ‘taking the piss’, not giving it! I can’t believe a person with medical training would actually do that, you know… :/

    — David N. Andrews BA-status, PgCertSpEd (pending)    Sep 1, 12:55 PM    #

  16. “The elephants in the room”

    Roll up, roll up. Mercury supplements free with every vaccine. Preserve your child for life against life threatening viruses. Mercury’s unique toxic properties help kill all threatening viruses, allowing your child to develop into a healthy adult. First jab free!!

    — kevin_1000    Sep 7, 04:37 PM    #

  17. Dose makes the poison. Drinking bleach is not good for your health, but disinfectants in public pools keep us all a little safer.

    — Ruth    Sep 8, 10:55 AM    #

  18. When did you last inject yourself with bleach/disinfectant?

    — kevin_1000    Sep 8, 11:48 AM    #

  19. K1K:”When did you last inject yourself with bleach/disinfectant?”

    No need. Your body produces it’s own bleach and other disinfectants. K?

    — clone3g    Sep 15, 09:14 PM    #