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The Geier story on testosterone shifts again

19 Apr

When Mark and David Geier first proposed using Lupron on autistic children, it was supposedly to help remove mercury from the brain. Their theory was that mercury and testosterone bound together in the brain and that this prevented chelators from being able to remove the mercury. They first approached the Rev. Lisa Sykes, whose son was one of their patients, with the idea. You can hear her discuss that encounter here.

The blurb for that video was:

The Reverend Lisa Sykes is the mother of a recovering autistic boy (Wesley) and an ordained minister, currently serving as Pastor for the Christ United Methodist Church in Richmond, Virginia. In this interview, Rev. Sykes discusses how she came to having her son treated using the Geiers’ “lupron” protocol to more effectively remove heavy metals by first lowering Wesley’s abnormally high testosterone levels.

In the video, Rev. Sykes quotes David Geier (Mark Geier’s non-doctor son and partner in his clinic and research) in the video as saying:

“Do you know, we’ve figured something out!”

“We think we can get rid of the mercury by lowering the testosterone”

As the Geiers and the Rev. Sykes have been major proponents of the failed mercury causation idea, this is not surprising.

The science behind the idea was bad. To the point of laughable, if it weren’t for the danger posed to disabled children.

Mr. Geier has since had his license to practice medicine suspended, in large part due his “Lupron protocol” and the way he misdiagnosed children with “precocious puberty” in order to prescribe Lupron.

The Geiers and Rev. Sykes have a new paper out: “An evaluation of the role and treatment of elevated male hormones in autism spectrum disorders.”

The word “mercury” doesn’t appear in the main body of the paper at all. Just in a citation to one of the Geier team early papers. But they do conclude:

Anti-androgen therapy should be considered as an effective means to significantly help improve clinical features of patients diagnosed with an ASD.

The paper was published in Acta Neurobiol Exp, a journal by the Neuroscience Society. The journal has an editor who is a proponent of the idea that vaccines cause autism and has a history of publishing low quality papers promoting the idea.

Frankly, I see this as an attempt by the Geiers to create a defense for their previous actions, those which resulted in Mark Geier’s license suspension. By distancing themselves from both the purported chelation idea and the precocious puberty idea they can create a justification for why they treated disabled children with a drug for which there was no clinically indicated need.

Suspension of Mark Geier is upheld

19 Apr

Mark Geier is a name well known in the autism world of alternative medicine as well as a major source of papers purporting to link autism to mercury. He had a medical practice, was licensed in multple states, presented repeatedly at autism parent alt-med conventions, and served as a witness for the vaccine court.

Mr. Geier’s license to practice medicine was suspended last year. Since then he has tried a few avenues to get his ability to practice reinstated, at least while he is pursuing appeals. The Maryland State Board of Physicians has denied his request and issued a (second) cease and desist order informing him to stop practicing medicine.

Mr. Geier and his son, David Geier, took a theory from Prof. Simon Baron-Cohen: the “extreme male brain” concept of autism. Where Prof. Baron-Cohen focused on the effects of fetal testosterone levels on brain development, the Geier team somehow arrived at the idea that autistics have mercury bound in to testosterone in their brains. One can read an analysis of this theory at A Photon in the Darkness, Miscellaneous Mercury Nonsense. As you can imagine from the title of that article, the autism/mercury/testosterone idea was an obviously bad idea from the start.

Unfortunately, the Geiers took this bad idea from theory to practice. They further hypothesized that these mercury/testosterone sheets prevented chelators from removing the mercury. So, they futher hypothesied, by reducing the amount of testosterone in the body, the mercury bound in these supposed mercury/testosterone sheets would be released allowing chelators to remove the mercury. Why lower levels of testosterone would lead to these supposed mercury/testosterone complexes breaking down is not well explained. Which is another way of saying it doesn’t make sense.

It is worth noting that these sheets, or matrices as the Geiers dubbed them, of mercury and testosterone do exist. In laboratories. After boiling mercury compounds in beakers of benzene. As Prometheus wrote back in 2006:

This is not a condition even remotely similar to anything found in living tissue – of any vertebrate species. In other words, it isn’t likely to happen in autistic children unless you dissolve them in hot benzene.

Basically every link in their logic chain was bad. But this did not stop the Geiers from applying Lupron as a treatment. The drugs for reducing testosterone production (such as Lupron) are expensive. Insurance doesn’t pay for Lupron to reduce testosterone levels in disabled children so that non-existent mercury/testosterone sheets will break down by some unexplained mechanism so that chelators can remove the mercury which is not really linked to autism. Probably because of the insurance angle, the Geier’s prescribed Lupron and similar drugs not for the supposed ability to help the chelating process, but to treat precocious puberty. Early onset of puberty.

According to the Maryland Board, based on records and testimony from patient’s parents, the Geiers failed to do the basic work involved in diagnosing precocious puberty and, in some cases, diagnosed precocious puberty in children who were old enough to be going through puberty.

Sound complicated? They were diagnosing precocious puberty without the proper tests in children who didn’t have it in order to prescribe drugs to reduce testosterone levels so that mercury/testosterone sheets which don’t exist in their brains will break down and allow a chelator to remove the mercury which doesn’t cause autism.

Lupron is not a mild drug. It reduces sex hormones and delays puberty. Children are supposed to go through puberty at a given time in their lives and delaying it comes at a cost. In addition the drug itself has side effects. From the recent decision upholding the suspension of Mr. Geier’s license:

Lupron treatment carries a very high risk of skin abscesses and infections, and it is contraindicated in patients with a history of seizures. Dr. Geier nevertheless prescribed it for Patient B, who had a history or uncontrolled seizures. Nor did Dr. Geier perform all of the necessary diagnostic procedures before prescribing Lupron. Nor did Dr. Geier physically examine Patient B until almost three years after he began prescribing for him. See Proposed Decision at 33, 37-38. This is only one example of the truly risky behavior that Dr. Geier engaged in with these patients.

Mr. Geier’s license to practice medicine was suspended last year by the Maryland Board of Medical Practice. He tried to defend himself in a series of actions since, with this action being the final word.

The Board “entirely agrees” with the a previous decision that allowing Mr. Geier to continue to practice medicine while awaiting the determination of formal charges raises the likelihood of serious harm to public health and safety:

The ALJ concluded that “allowing [Dr. Geier] to continue practicing medicine while formal charges are pending raises a substantial liltelihood of risk of serious harm to the public health, safety, or welfare.” The Board entirely agrees. For Dr. Geier to practice medicine at this time would constitute a danger to the patient community.(3)

The footnote (3) in the above statement was already quoted in this artice–look above to the paragraph on “Lupron treatment carries a very high risk…”

The Board repeated this position in their conclusion:

“I conclude that for all these reasons, the Patients’ health, safety or welfare was at risk of serious harm.. Further, the existence of all these problems throughout all the Records raises a substantial likelihood that the risk of serious harm to the Patients was also posed to many other children with autism treated by the Respondent. I find that this meets the necessary standard for summary suspension of the Respondent’s license: allowing him to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety, or welfare,”

One very troubling argument made by Mr. Geier was that he was not required to have an Institutional Review Board for his research. One of the charges against Mr. Geier involved an IRB he instituted–where he, his son, his wife, a patient’s mother and other interested parties were members of the IRB. The Board did not address whether such a board was required, but did dismiss the charge based on the lack of evidence put forth by the State. More discussion on the IRB can be found at Neurodiversity.com in the article An Elusive Institute.

The Respondent argued both that he was not required by federal law to have an Internal Review Board and, that even if he was bound by such a requirement, the State failed to produce any evidence that his board operated in a flawed manner. The State did not dispute this argument in its response to the Motion. I agree with the Respondent that the State failed to produce sufficient evidence to survive a motion for judgment on the allegations related to an Internal Review Board. See COMAR 28.02.01.12E. C’ Md. Rule 2-519. I will recommend that this portion of the Motion be granted and further recommend that paragraphs 157 through 162 of the Order for Summary Suspension be dismissed.

The thought that somene (Mr. Geier in this case) believes that research could be performed on anyone, not just disabled children, without the protection of an IRB is frightening.

In what is to this reader the most ironic statement by Mr. Geier in this action:

Finally, Dr. Geier accuses the ALJ of establishing a new and unwarranted standard for the medical care of children with autism. Again, Dr. Geier fails to acknowledge that the ALJ relied to some extent on the testimony of his own expert witnesses, and on his own sworn statement, to make her findings regarding the standard of care and the deficiencies in Dr. Geier’s practice.

Yes. Dr. Geier accuses the ALJ of establishing a “new and unwarranted standard for the medical care of children with autism.” Mr. Geier, who while he may not have been the first to promote chelation for autism has been one of the primary proponents, Mr. Geier is part of the team who invented the idea of Lupron as a part of a chelation protocol. A “new and unwarranted standard for medical care of children with autism”.

In addition to this decision, and the cease and desist order, Mr. Geier’s licenses to practice have been suspended in California, New Jersey, Indiana, Florida, Ohio, Washington and Virgina.

The Maryland Board accepted James Adams (a materials scientist) as an expert on chelation, at the behest of Mr. Geier. The opinions offered by Mr. Adams differ from those of medical toxicologists (a group of physicians trained and in practice to treat poisoning):

The Respondent [Geier] testified in his sworn statement that he orders chelation therapy for hispatients on “various” schedules “every other day or a few days on and a few days off for a couple of months – three months.” State’s Ex, 8 at 34. Yet, the Respondent’s expert on chelation, Dr. Adams, testified credibly that patients need an even longer break between rounds of chelation: three days of chelation followed by eleven days off. Dr. Adams also testified that chelation therapy should only be initiated after a patient is given a short “challenge” dose of chelation to ensure that the patient actually needs the therapy. If administered to a patient who does not need it, chelation poses serious risks of injury to the brain and other organs. It is imperative, therefore, that a physician only administer chelation on a limited basis to the patients who actually need it. The Respondent not only skipped the challenge step necessary to ensure chelation was even necessary, but then went full force into chelation therapy on an intensive schedule (with an experimental drug.not FDA-approved for that purpose) without appropriate rest breaks. In several cases, moreover, the Respondent failed to regularly monitor the effects of chelation, and in two cases he prescribed it for patients that he knew he could not monitor.

The concept of a “challenge test” for diagnosing mercury intoxication is covered by the American College of Medical Toxicologists in American College of Medical Toxicology Position Statement on Post-Chelator Challenge Urinary Metal Testing. Who concluded:

“It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

I hope that the Maryland Board looks into this issue of challenge testing before ruling again on such issues.

Mr. Geier is scheduled to give a talk at a large annual autism-parent convention. Last year, after the first action suspending his license, he was reportedly given a standing ovation at this convention. This reader is at a loss to understand why.

COALITION FOR MERCURY-FREE DRUGS (COMED, INC.) v. SEBELIUS

15 Mar

The Coalition for Mercury Free Drugs (CoMeD) is an organization run by Mark and David Geiers. This is the father/son team which has promoted some of the most questionable research trying to link autism (and more) to mercury, especially in vaccines. They are also notorious for their “lupron protocol”, a therapy where a strong drug is used to reduce sex hormones in a bid to remove heavy metals from the body (if this doesn’t make sense to you, don’t worry about your understanding. It doesn’t make any sense).

CoMeD petitioned the secretary of health and human services (Kathleen Sebelius) to stop all use of thimerosal containing vaccines. The original petition was denied, and, now, Their appeal was dismissed.

We recognize plaintiffs’ genuine concern about thimerosal-preserved vaccines. But plaintiffs are not required to receive thimerosal-preserved vaccines; they can readily obtain thimerosal-free vaccines. They do not have standing to challenge FDA’s decision to allow other people to receive thimerosal-preserved vaccines. Plaintiffs may, of course, advocate that the Legislative and Executive Branches ban all thimerosal-preserved vaccines. But because plaintiffs are suffering no cognizable injury as a result of FDA’s decision to allow thimerosal-preserved vaccines, their lawsuit is not a proper subject for the Judiciary. We affirm the judgment of the District Court.

The decision ended simply: “We affirm the District Court’s judgment dismissing plaintiffs’ suit for lack of standing.”

Mark Geier: Cease and Desist

26 Feb

From the Baltimore Sun: ‘Cease and desist’ order issued against autism doctor

Dr. Mark R. Geier, a Rockville doctor accused of improperly treating children with autism, has been ordered by the state Board of Physicians to stop practicing medicine while his license is suspended.

The doctor’s license was suspended in April after the board concluded his hormone and chelation therapy endangered the children in his care. But the board in a new “cease and desist” order this week accused the doctor of refilling prescriptions for at least three patients in violation of the suspension.

The doctor has appealed the suspension of his license. His lawyer declined to comment on the newest claims.

Is Mark Geier finished as an expert witness in the vaccine court?

10 Dec

Dr. Mark Geier is a name which has come up frequently in the autism/vaccine discussion, and in alternative medical therapies (such as Lupron) of autism. Dr. Geier has been an expert witness for petitioners in the vaccine court for about two decades. He has been criticized by the court for almost as long. Dr. Geier has recently had his medical license suspended.

Mark Geier and his son David have worked for the Petitioners Steering Committee (the lawyers handling the plaintiffs’ cases in the Autism Omnibus). But their relationship seems a bit strained. They filed suit asking for $600,000 in payment. The Geiers have had previous requests for fees drastically reduced or denied, including one where they expected the Court to cover $20,000 as their costs (and hourly rate, including while sitting on planes) to attend conferences in Italy and France. The court called this “a complete abdication of billing judgment.”

In a recent court decision, Dr. Geier has been criticized again. Thoroughly. But this very strong statement from the special master makes it clear that Dr. Geier’s future as an expert witness or consultant will be very restricted:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

The decision focused on expenses the Petitioner’s Steering Committee (PSC) charged in the Omnibus Autism Proceeding for Mark Geier, his son David Geier and their colleagues. Much of these charges resulted from a study they published, Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. Epiwonk (a former professional epidemiologist for the CDC) discussed the paper in New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?

The study noted in the acknowledgements that the study was funded by the PSC:

This study received funding from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).

The Geier/Young team billed the PSC, and the PSC billed the vaccine injury trust fund vaccine court. As you can read, they just weren’t successful.

The Geiers tried some fancy footwork to get the Young-Geier study paid for by our tax dollars.  Including an apparent attempt to get the non-doctor David Geier compensated by charging work at their company, “medcon”, rather than naming David Geier as the recipient.

Bottom line–the PSC asked for $440k to compensate the people who worked on the Young-Geier study.  They got $33k, and a strong statement that Geier will be unlikely to be compensated by the program in the future.

If you are curious about the value of the study itself, there is a whole section of the decision titled “The Young-Geier article itself did not add any value to the petitioners’ causation case.”

In their application, the PSC sought a total of $7,202,653 for interim fees and costs. with $1.35M for costs, primarily expert witness costs (note that the Geiers did not actually serve as witnesses, so they are part of the “costs”)

Out of $1,350,000 in costs one might ask how much of this was for the Young-Geier study?

As noted above, this Decision on Remand concerns the PSC’s claim for compensation for amounts paid, or to be paid, to four experts/consultants: Dr. Mark Geier, David Geier, Dr. Heather Young and Dr. Robert Hirsch. Conceptually, this claim can be broken into two parts. First, petitioners seek $447,004.02 to compensate all four of those individuals for work on an original medical article that was published in 2008. Second, petitioners seek $197,823.94 more for miscellaneous additional services provided by Mark Geier and David Geier between 2003 and 2008.

$447K. One third of the total. A large number of expert witnesses actually produced reports and testified, but the Geier team was to receive 1/3 of the total. If you take a high rate of $500/hour, this works out to 22 full time man weeks. For a study where they didn’t have to collect data, just analyze it. I find it difficult to believe this study took 22 weeks (or more, as the $500/hour is a very high estimate).

The Geiers were not slated to get the majority of the money. Heather Young, an associate professor at George Washington University, was to get the lion’s share. About a quarter of a million dollars:

Petitioners would receive $248,636.91 to compensate Dr. Young, $157,407.11 for the two Geiers, and $41,000 for Dr. Hirsch

Unless GWU pays their associate professors much more than is common, this represents well over one year’s pay for Prof. Young.

Thankfully HHS (respondent) argued against this request:

Respondent argues strenuously, in response, that it would be wholly unreasonable for the Program to provide compensation to these individuals for their efforts concerning the article.

Is it reasonable to charge for studies created for litigation? Are they of high value to the case?

I note that the Supreme Court has expressed the view that medical studies produced expressly for litigation purposes should be viewed with skepticism.

and

The views of these courts, then, reinforce the concern that if a lawyer involved in a Vaccine Act case chooses specific experts and pays them to carry out a study, the potential is great for bias in the study, toward the outcome that would assist the clients of the lawyer paying for the study. Thus, it is arguable that, as the respondent contends, it would be poor public policy, in general, for special masters to award public funds for such original studies.

and

Rather, I conclude that under all the specific circumstances of this case, it would not be reasonable for me to compensate the named individuals for the production of this particular article.

The PSC argued that the paper was not “litigation driven”.  The SM didn’t accept the argument:

As to the former point, I am simply not persuaded by the suggestion that the article was not litigation-driven….The mere fact that the PSC lawyers contributed or promised monetary support for another article co-authored by the Geiers, concerning the topic of whether thimerosal-containing vaccines can cause autism, is itself strong evidence that the article was litigation-driven.

Further, the very fact that the petitioners are now seeking Vaccine Act funds for the cost of producing the article is a very strong indication that the article was litigation-driven.

If that wasn’t enough, the PSC argument backfired in another way:

If the article was produced “completely apart from [Dr. Geier’s] involvement in this [Vaccine Act] litigation,” and would have been produced even absent that litigation, that would seem to contradict the petitioners’ claim that paying the cost of producing the article was a necessary and reasonable cost of the Vaccine Act litigation.

How was the Young-Geier study used in the Omnibus? Was it persuasive? Answer: it wasn’t really used and it wasn’t persuasive.

The HHS/DOJ’s experts were critical of the Young-Geier study:

Perhaps the strongest factor leading to my result here is my conclusion that the Young-Geier article itself did not add any value to the petitioners’ causation presentation in this case. Two epidemiologic experts, both of them testifying for respondent, testified at the trial in this case concerning the merits of the Young-Geier article, and both testified that the article was deeply flawed.

Even the PSC’s own experts were not impressed by the Geiers in general:

And, very significantly, none of the petitioners’ five medical experts who testified at the trial offered any testimony in support of the validity of the Young-Geier article. It is especially striking that among petitioners’ experts was an expert who has excellent credentials in epidemiology, Dr. Sander Greenland. Dr. Greenland in fact testified negatively about the Geiers’ prior epidemiologic articles concerning the vaccine-autism controversy, describing those studies as“deficient in methodology.”

Prof. Greenland didn’t speak to the Young-Geier article directly, just their methods in other studies.  But the special master points out that this appears to be a trick on the part of the PSC to avoid having to defend the Young-Geier study on cross examination:

Yet they [the PSC] put Dr. Greenland on the witness stand in this King case on May 12, 2008 (Tr. 69-135), did not ask him about the article, and did not reveal the existence of the article to the special masters and respondent until May 16 (see fn. 6 above), thus ensuring that no one could ask Dr. Greenland about the Young-Geier article. From these circumstances, the most reasonable inference is that petitioners’ counsel deliberately intended to avoid any questioning of Dr. Greenland, their epidemiologic expert, about the Young-Geier article.

The special master concludes that the study did not add any value to the PSC’s case and “no rational hypothetical paying client” would have agreed to pay for the production of such a “flawed study”:

In short, the Young-Geier study itself was severely criticized by respondent’s experts, who articulated persuasive reasons for that criticism. In my own analysis, the Young-Geier study also appears flawed. And the other special masters who reviewed that article reached the same conclusion. Clearly, no rational “hypothetical paying client” of the PSC would have agreed to pay for the production of such a flawed study. Thus, the fact that the Young-Geier article did not add any value to the petitioners’ causation presentation in this case is a very strong reason why I should decline to compensate the PSC for the cost of producing the article.

The Special Master notes that given the long history of the Geiers in the vaccine program, it would be unreasonable to expect the program to pay for the cost of the study:

A review of prior legal opinions discussing the Geiers casts strong doubt on the reasonableness of compensating the cost of an article co-authored by them.

The Special Master then goes into detail of those decisions , with an entire section  of the decision dedicated to “Vaccine Act opinions concerning the general credibility of Dr. Geier as an expert witness” including subsections “Criticisms of Dr. Geier for offering testimony outside his area of medical specialty” and “Opinions questioning Dr. Geier’s honesty, candor, or veracity” and “Opinions declining compensation or substantially reducing compensation for Dr. Geier’s services”

If you get the time, read through those. They are highly critical. A condensed version of 20 years of highly critical comments about the actions of the Geiers in the vaccine program (mostly Mark Geier):

Criticism of the Geiers is not limited to their activities in the Vaccine Court. In “Judicial opinions outside of the Vaccine Act” they quote decisions stating “federal appellate court concluded that Dr. Geier gave erroneous testimony” and “state court found Dr. Geier’s testimony to be “unsubstantiated” and unpersuasive” and “federal court was “unimpressed with the qualifications, veracity, and bonafides” and, lastly, “federal judge stated that he was “unconvinced” that Dr. Geier was qualified to offer testimony concerning certain vaccine safety issues.”

The Special Master went into detail about previous flawed studies by the Geiers on vaccines and autism.  He also notes that the assertion that Dr. Geier is qualified as an epidemiologist is not supported:

Thus, Dr. Geier does not appear to have had any formal academic training or degrees or medical faculty experience in epidemiology, and his medical experience has been chiefly in genetics rather than epidemiology. Thus, it is unclear why he was named a “Fellow” of the American College of Epidemiology, and it is doubtful whether he should be considered an expert in epidemiology. I conclude that the petitioners have failed to shoulder their burden of demonstrating that Dr. Geier should be considered an expert in epidemiology.

and

Further, a number of judges and special masters have also examined Dr. Geier’s credentials, and have specifically concluded that Dr. Geier should not be considered an expert in epidemiology.

He awards fees, as a consultant not expert, for Mark Geier’s other efforts on the Omnibus:

Accordingly, I awarded $33,130.35 (147.246 hours times $225 per hour) for the services of Dr. Geier.

No mention of payment for David Geier or Heather Young.

The Special Master makes it clear that even this amount was grudgingly awarded. Given that *in the past* it was reasonable to hire Mark Geier as a consultant:

I note that it is not an easy judgment whether to award any funds for the services of Dr. Mark Geier in this case. On balance, I conclude that, in light of the cases awarding funds to Dr. Geier as a consultant (see p. 33 above), it was not unreasonable in this instance (several years ago) for the PSC to employ Dr. Geier for consultant services.

But, after 20 years, the vaccine program may have had enough of Mark Geier:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

(emphasis added)

If the court won’t pay his fees, the career of Mark Geier as an expert for vaccine injury cases is over. His son David is not likely to be taking his place, as he has not been considered even viable as a consultant by the special masters. As noted above, Mark Geier’s license to practice medicine has been suspended (in multiple states). David Geier was charged with practicing medicine without a license. One has to wonder if or how the Geiers will re-emerge on the autism/vaccine scene.

Mark Geier: vaccine lover

7 Sep

Sometimes reality is just stranger than fiction. Consider Mark Geier. He’s the doctor whose license has been suspended in Maryland for his treatment of autistic children with Lupron. He’s been a regular expert witness in the vaccine court for something like 20 years. He’s got multiple papers out on the dangers of mercury in vaccines.

Think that’s enough to please the vaccines-cause-autism crowd? Think again.

Stroll over to Facebook where a heated discussion is ongoing.

…you’re wrong on that one…. from personal experience having dinner with Dr. Geier….he has no problem with the vaccines other than mercury. He told me to my face at dinner that he gave his patients the H1N1 vaccine last year (Hg free of course). Sorry, but that is from personal experience….he’s a hack in my book.

Yep. Giving vaccines makes one a hack. Treating faux precocious puberty, not so much.

the response?

…thanks for saying that…I detected he was a vaccine lover.

Yep, he’s a “vaccine lover”. Mark Geier. That’s his failing.

… I know I’ll probably make some enemies over this but I call em’ as I see em’ and this was NOT hearsay. He told me that to my face at dinner…I got up, called him a moron and didn’t come back to finish my dinner. I fumed all night!

Well, there you have it. Tell the wrong people you gave vaccinations and you are a hack, a “moron” and you make people lose their appetite.

The world never ceases to amaze.

Mark Geier: under scrutiny in more states

29 Jul

In Home Autism doctor here under scrutiny, The St. Louis Post Dispatch discusses investigations ongoing in Illinois:

A autism doctor who operates clinics in St. Peters and Springfield, Ill., has been suspended in two states for alleged mistreatment of children.

Dr. Mark Geier has been accused of misdiagnosing children with early puberty and treating them with high doses of Lupron, a drug used to suppress the hormone testosterone.

A hearing will be held on August 22nd to consider Dr. Geier’s license in the state of Illinois.

The Post Dispatch notes that Dr. Geier’s hypotheses and methods are far from generally accepted:

Dr. John Constantino, a psychiatry professor and leading autism researcher at Washington University, said Geier “understands the tools of science but has applied them in questionable ways” to justify specific treatments.

“There is currently no scientific evidence to support the clinical use of Lupron to treat autism in anything other than carefully conducted research trials,” Constantino said.

Autism News Beat in Castration doctor’s license now suspended in four states notes:

Dr. Mark Geier, the Maryland physician who chemically castrates disabled children, is still licensed to practice medicine in seven states, down from eleven. Four states have suspended or revoked his privileges since April 27, when his home state took action against him. Washington followed on May 26, then Virginia on June 9. On June 29, Indiana issued an emergency 90-day suspension, citing the Maryland action.

Mark Geier: My therapy is unconventional, but it works

17 Jun

Dr. Mark Geier is appealing the suspension of his medical license. The license suspension order includes (as summarized by Kathleen Seidel at Neurodiversity.com):

• In six out of nine of these cases, the board determined that the children were misdiagnosed with precocious puberty. Children were diagnosed with precocious puberty without the benefit of a physical examination; some were too old to qualify for the diagnosis.

• Medical records and medical necessity letters prepared by Dr. and Mr. Geier indicated that children were diagnosed not only with precocious puberty, but also with pituitary dysfunction, insomnia, aggression, mitochondrial disorder, metabolic dysfunction, and “heavy metal toxicity” when neither test results nor parent reports suggested anything of the sort.

• In one case, the only record of the diagnosis of precocious puberty was a code number entered onto a standing order for lab tests. In another, no note was made in the medical records of the date the child began treatment with Lupron. Yet another patient’s file contained no indication that Dr. Geier reviewed any of the results of the numerous, burdensome diagnostic tests he had ordered.

• The order describes claims submitted to at least one insurance company for a psychiatric interview and “prolonged evaluation and management” services that were never rendered.

• The order further describes an occasion when David Geier, who is not licensed to practice medicine, conducted a medical evaluation and diagnostic tests, made diagnoses, and recommended treatments for an autistic boy in Dr. Geier’s absence.

• Additionally, the Board determined that Dr. Geier misrepresented his qualifications as a geneticist, and misrepresented the ability of his Institutional Review Board to conduct oversight of his research.

Dr. Geier has taken his case to the public in an opinion piece in the Baltimore Sun: Autism doctor: My therapy is unconventional, but it works. He certainly has the right to present his case to the Sun, and while I would not have published the letter were I editor, the Sun is within its rights to host the letter. I am within my rights to comment on the letter, and I took that opportunity in the comments as you will see (complete with typos) if you follow the link.

Dr. Geeir opens with a simple statment “If there’s a single statement that everyone who works in the field of autism can agree on, it’s that there is so much that we still don’t know.” This is incomplete: there is much we do know. We know that the theories Dr. Geier has proposed are wrong. We know that the rise in autism is not due to mercury. Certain tests should be performed before a child is diagnosed with precocious puberty. Tests which the charges indicate Dr. Geier failed to do on many occasions. We know that treatment for precocious puberty should stop at an age when puberty is expected. Dr. Geier is charged with initiating and/or continuing treatment in children too old to be diagnosed with precocious puberty.

Dr. Geier has published many papers in the literature, this is true. These papers have been widely criticized by researchers. Not because the ideas are unconventional, but because the ideas are ill founded and the experimental methods are poor. Dr. Geier has been described as “intellectually dishonest” for his work as an expert witness. The Institute of Medicine has referred to Dr. Geier’s papers as suffering from “serious methodological flaws and their analytic methods were nontransparent, making their results uninterpretable”

There is much we do not know. On thing we do know: we deserve better than Mark Geier

Perhaps it is the frustration of having read the recent article by the Geiers in the new “autism science digest”. Perhaps it is the fact that I listened to a podcast interview with the Geiers in preparing my recent response to the article. Perhaps it is just the years of reading bad science and waiting for someone to act against these people, but my patience is worn rather thin, as you will see in the comments.

AutismOne throws their support behind the Geiers in “Autism Science Digest”

16 Jun

When news came out about the legal troubles Mark and David Geier are facing, there was some hope expressed that maybe, just maybe, some of the groups that have supported the father/son team would take the chance to distance themselves. The Generation Rescue/Autism One conference was at that time still in the future, and the Geiers were scheduled to speak. Dr. Mark Geier had his license suspended for the “therapy” he was planning to tout at AutismOne, and that David Geier was facing the charge of practicing medicine without a license.

As we have seen, the optimism was ill founded. The Geiers presented their talk at AutismOne. And, as it turns out, AutismOne had already in-press their new magazine, the “Autism Science Digest”, which included an article by the Geiers. Someone forwarded it to me and it is frankly painful to read.

It is a nice glossy advertisement for the Geiers and their testosterone/autism theory. I don’t throw that out lightly. It is pseudo-science generated to promote an idea. and idea which really doesn’t stand up to real science.

For example, they present the article like a science study, complete with references. It makes it seem as though what they say is backed up by legitimate science. But citations do not make a study. Especially when they are misused.

It is difficult to describe the Geier hypothesis. This is for two reasons. First, it is hard to accept that they actually believe their own work, it is so bad. Second, it has morphed dramatically over the few years of its existence.

Let me explain. When they first proposed their idea that testosterone was somehow important, they claimed that testosterone was binding mercury in the brain, rendering it difficult to remove through chelation. If you listen to Lisa Sykes talk about the Geiers (the Rev. Sykes being a major spokesperson for the Geiers over the years), she tells how David Geier told her, “We figured something new out…..we think we can get rid of the mercury by lowering the testosterone”.

By the way, the Rev. Sykes mentions that she tested her child for testosterone. The range was 0 to 25 and her kid was “at the top of the range”. Not above it. At the top. As in, high but within normal.

If you listen to the Geiers speak now (and, again, I find this painful to do), they are still pushing the idea that mercury is the main causation factor in autism. But, here’s the shift with Lupron, they are downplaying the idea that is part of a chelation protocol. It’s all about reducing testosterone.

Is anyone surprised that if you change the testosterone levels in a person you will see changes in behavior? Does this have anything to do with autism? Does it have anything to do with mercury?

The Geier article relies heavily on the work of Dr. Simon Baron-Cohen’s group. They cite Dr. Baron-Cohen’s group 5 times in their article. It makes the article look legitimate. The first paragraph states, “In fact, ASD’s have even been described as the result of an “extreme male brain” by psychologist Dr. Simon Baron-Cohen”.

At this point, it is worth recalling what Dr. Baron-Cohen had to say about the work the Geiers are doing:

Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.

“The idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror,” he said.

Some how “fills me with horror” was not included in the Geier article.

Dr. Baron-Cohen’s theories include the idea that fetal testosterone levels affect the development of the brain. This is a prenatal process. The Geier notion is that autistics have high testosterone levels (even though they have documented cases of children they treated who do not have high levels). It is intellectually (and otherwise) very dishonest to claim that the work of Dr. Baron-Cohen in any way supports the Geier’s application of the drug Lupron to autistic children.

It isn’t just Dr. Baron-Cohen’s work that is misused to sell this therapy. The Geier’s write, “”Also, some investigators have found that leuprolide acetate administration resulted in improvements in cognition” ( Bryan et al. , 2010)”

Here is the abstract for Bryan, et al.:

Down-regulation of serum gonadotropins is as effective as estrogen replacement at improving menopause-associated cognitive deficits.
Bryan KJ, Mudd JC, Richardson SL, Chang J, Lee HG, Zhu X, Smith MA, Casadesus G.
Source

Department of Neurosciences, Case Western Reserve University, Cleveland, Ohio, USA.
Abstract

Declining levels of estrogen in women result in increases in gonadotropins such as luteinizing hormone (LH) through loss of feedback inhibition. LH, like estrogen, is modulated by hormone replacement therapy. However, the role of post-menopausal gonadotropin increases on cognition has not been evaluated. Here, we demonstrate that the down-regulation of ovariectomy-driven LH elevations using the gonadotropin releasing hormone super-analogue, leuprolide acetate, improves cognitive function in the Morris water maze and Y-maze tests in the absence of E2. Furthermore, our data suggest that these effects are independent of the modulation of estrogen receptors alpha and beta, or activation of CYP19 and StAR, associated with the production of endogenous E2. Importantly, pathways associated with improved cognition such as CaMKII and GluR1-Ser831 are up-regulated by leuprolide treatment but not by chronic long-term E2 replacement suggesting independent cognition-modulating properties. Our findings suggest that down-regulation of gonadotropins is as effective as E2 in modulating cognition but likely acts through different molecular mechanisms. These findings provide a potential novel protective strategy to treat menopause/age-related cognitive decline and/or prevent the development of AD.

The short version: the authors removed the ovaries from mice, putting them into a menopause state. They found that these mice decline cognitively, but that they can treat this with a leuprolide acetate (a drug similar to lupron).

Yes, somehow the animal model for autism to the Geiers are post-menopausal mice.

This study has nothing to do with improving cognition in children, or autistic children in particular. Don’t take my word for it. I contacted one of the researchers who wrote the paper:

Well… The principle of gonadotropins working on cognition in menopausal women or patients with AD has nothing to do with autism nor with improving cognition via the depletion of gonadal steroids such as testosterone or estrogen. For example, we know that when women that are in reproductive age (and men to a lesser extend) are given leuprolide their cognition is impaired, indicating that gonadal steroids are important for cognition. However, we have shown that after menopause, gonadal steroids can be by-passed by downregulating gonadotropins to improve cognition.

If you want the message in a single sentence:

The beneficial effects of leuprolide on cognition in ovariectomized (menopausal) female mice has nothing to do with the treatment of autism in children.

Another study the Geiers cite: “Increased marble-burying behavior in ethanol-withdrawal state: Modulation by gonadotropin-releasing hormone agonist”

No, I am not kidding. It is a study about alcoholic mice burying marbles. Here’s the abstract:

A characteristic behavior in alcohol abstinence state indicates the possibility of obsessive–compulsive behavior in alcoholics. Ethanol is known to reduce hypothalamic synthesis, release, and mRNA expression of gonadotropin-releasing hormone (GnRH) that modulates serotonergic, dopaminergic, and glutamatergic systems, which experience adaptive changes on chronic exposure to ethanol. Such changes are also evident in obsessive–compulsive disorder. Therefore, it was proposed to investigate the effect of ethanol-withdrawal on marble-burying behavior in mice, particularly because it simulates some aspects of obsessive–compulsive behavior; further, the influence of GnRH agonist was studied on the same. Ethanol-withdrawal state was induced after its chronic administration, and marble-burying behavior was observed at 0, 6, 24, 48, and 96 h interval. Further, the influence of leuprolide—a GnRH agonist (50–600 ?g/kg, s.c.) or fluoxetine (5–30 mg/kg, i.p.) was investigated on ethanol-withdrawal-induced changes in marble-burying behavior. The results indicated that ethanol-withdrawal led to a gradual increase in marble-burying behavior upto 48 h with peak at 24 h interval. Administration of leuprolide (100–600 ?g/kg, s.c.), 30 min prior to 24 h interval, dose dependently reduced ethanol-withdrawal-induced increase in marble-burying behavior, and this effect was comparable to that of fluoxetine (15 and 30 mg/kg, i.p.). Further, twice daily administration of leuprolide (50 ?g/kg, s.c), concomitant with ethanol, prevented the gradual increase in marble-burying behavior after ethanol-withdrawal and this effect was comparable to fluoxetine (5 mg/kg, i.p.). In conclusion, ethanol-withdrawal on chronic administration increases marble-burying behavior in mice; its development and expression is attenuated by leuprolide.

The researchers gave mice alcohol over a long period. When they made the mice stop, cold turkey, they exhibited behaviors such as burying marbles. While the mice are going through the first stages of withdrawl, the researchers gave them a lupron like drug and found that the mice didn’t bury marbles as much.

Once again, who finds this to be a valid animal model for autism? Is your child an alcoholic, marble-burying mouse?

But you don’t see this if you just read the article. What you read is, “similarly, other investigators have used an anti-androgen medication called leuprolide acetate, which reduces the production of male hormones, in the treatment of anxiety, hyperexcitability, depression, impaired social interaction, and obsessive compulsive behaviors in laboratory animal species”.

The Geiers have obviously felt the need to respond to the criticism that they are using a drug used for chemical castration. They write

Finally, the administration of anti-androgen medications to individuals diagnosed with an ASD is not intended to deprive the individual of their sexuality nor to alter their normal developmental trajectory, but rather to regularize a process that was proceeding in an abnormal fashion and producing adverse effects and, thereby, improve the health of the patient and reduce the clinical symptoms associated with abnormally elevated androgen levels.

Here is an example patient from the patent application the Geiers submitted (US20070254314A1: Methods of treating autism and autism spectrum disorders):

Laboratory analyses did not reveal elevated levels of mercury or elevated levels of at least one androgen. Specifically, undetectable levels of mercury were present in Child D’s urine and minimal levels of mercury were in Child D’s blood (1.5 ?g/L, reference range=0.0-14.9 ?g/L). Additionally, analyses of Child D’s blood androgen metabolites revealed a serum testosterone=153 ng/dL (age- and sex-adjusted LabCorp reference range=0-350 ng/dL) and serum/plasma DHEA=291 ng/dL (age- and sex-adjusted LabCorp reference range=183-383 ng/dL) within their respective reference ranges.
After extensive discussions with his parents concerning the risks, benefits, and alternative treatments available, a decision was made to place Child D on a course of LUPRON® therapy.

Yes, Child D has testosterone well within the normal level. And, yet, the child was treated with Lupron. How, exactly, does this fit with improving “…the health of the patient and reduce the clinical symptoms associated with abnormally elevated androgen levels”?

Also, in the Autism Science Digest article itself, the authors note:

The child underwent antiandrogen therapy until the age of 13, when he entered puberty at an age typical of his sibling

Age 13 is within the normal range to start puberty. So is 9. Why did they delay this child 4 years? As of age 9, the child was not in central precocious puberty.

The Geiers make this comment in their recent article:

Two months prior to his 9th birthday, he was given a test dose of leuprolide acetate. After administration, he went outside and began to swing on a tire swing using his feet to push – a neurotypical behavior never seen before.

Dramatic, isn’t it? First shot, and the kid goes outside and uses the swing for the first time. This caught my eye, because they mention swinging in their patent. In the patent they note, “Within a few days of the second shot of LUPRON DEPOT®, Child X learned to swing by himself using leg timing for propulsion”

I’m betting that this is the same kid. If so, did the kid get his first shot and go outside and start swinging, or did he go a few days after his second shot?

One issue the Geiers (and others) have faced is inflation of credentials. David Geier, for example, listed himself as a “diagnostician” to get on the Maryland Autism Commission. The Autism Science Digest article is no different. Mr. Geier gives as his credentials that he “Has been a research scientist at the National Institutes of Health in the laboratory of Biochemical Genetics.”

Take a moment, if you will, and think what that statement means to you, ” research scientist at the National Institutes of Health in the laboratory of Biochemical Genetics”. I ask you to do this before we see what his job really was.

We can read Mr. Geier’s resume here, which lists his experience including:

I. T. R. A. Summer Fellow Appointment at The National Institutes of Mental Health (under Laboratory Chief [Redacted] of The Laboratory of Biochemical Genetics)
Projects:
(1) Protein Gel and Phage Research

That was in the summer of 1998. That’s the summer before he entered college, if I read the rest of his resume correctly. At this point I have to do something I rarely do, point out my own credentials. I’ve been a summer intern. I’ve been a research scientist. I’ve been a research scientist supervising summer interns. While I find the work of my summer interns has been valuable and of high quality, they weren’t “research scientists” in the way that is clearly implied in the article. Sure, it would have taken more space to write, “He was an intern the summer of his freshman year at the NIH”, but it would have made his position much more clear.

Dr. Mark Geier lists as part of his credentials, “His extensive research has resulted in him being invited to address the Institute of Medicine at the U.S. National Academy of Sciences on six occasions.” I find it remarkable that he uses this to build credibility, given the fact that the IOM clearly was not impressed by his work.

Let’s look at what the Institutes of Medicine had to say about the Geiers’ research:

The first was an ecological study (Geier and Geier, 2004a) that reported a potential positive correlation between the number of doses of measles-containing vaccine and the cases of autism reported to the special education system in the 1980s. The second was a study of passive reporting data by the same authors (Geier and Geier, 2003c) that reported a positive correlation between autism reports in the Vaccine Adverse Events Reporting System (VAERS) and estimated administered doses of MMR. However, these two studies are characterized by serious methodological flaws and their analytic methods were nontransparent, making their results uninterpretable, and therefore noncontributory with respect to causality (see text for full discussion).

It isn’t news that the Geiers are poor scientists. It isn’t news that the Geiers have been called out for their ethical lapses multiple times over the years. It is fairly recent news that the Geiers have actually faced charges. And, yet, AutismOne and Generation Rescue continue to support this team by inviting them to speak at conferences and giving them space in their magazines to promote the same bad medicine that has cost Dr. Geier his license.

Dr. Geier has lost his license to practice medicine. To which I can only say, what took so long? What do they have to do to lose the support of the alternative medical community?

David Geier ousted from autism commission

24 May

O’Malley ousts David Geier from autism commission is an article at the Baltimore Sun.

Appointee, who works at father’s practice that offers controversial autism treatment, charged with practicing without a license

Gov. Martin O’Malley removed David A. Geier from Maryland’s Commission on Autism on Friday, telling his one-time appointee in a letter that “you do not at the present time qualify to serve.”

O’Malley told Geier, who has only a bachelor’s degree, that he does not qualify under Maryland law to serve as a “diagnostician,” the title he held on the advisory commission. The governor also cited charges brought against him this week by the Maryland Board of Physicians.

More at the Baltimore Sun, including:

“I regret that you were not willing to withdraw from the Commission and that this action is therefore necessary,” the governor said.

Yes. He was asked to leave. He didn’t. Now he’s being told.

David Geier is part of the father/son team which has promoted the “Lupron protocol” as a therapy for autism. The idea was incredible (as in, not credible) from the start. Their practice appears to have been using false diagnoses of precocious puberty in order to apply Lupron, a drug which shuts down sex hormone production.

Personally, I find it very strange that David Geier was placed on the autism commission to begin with. He clearly lacks expertise or connection to the community (other than financially, of course). This is before one factors in the facts that his entire model of autism is wrong from the word go.

AutismOne, potentially the largest parent-convention promoting the bad science of the Geiers and others starts on the 25th (the day after this post goes live). Mark and David Geier are scheduled to speak. One could hope that AutismOne would pull these speakers. Instead, 2 days ago, they posted a new interview. Complete with the message:

“These top researchers are at the forefront of helping to treat the “Tough Cases”. The symptomology of Precoscious Puberty and its safe treatment for ASD.”

“Top Researcher”

“At the forefront”

“symptomology of precocious puberty”

This is a team that has been charged with serious ethical violations, including the misdiangosis of the “symptomology of precocious puberty”. This is a team which has failed time and again to produce quality research.

But, this is a team which promotes the vaccines-cause-autism hypothesis.

Safety of disable children apparently comes second to ideology for Autism One.

Sorry to have dropped my usual rather dry reporting, but this is just plain wrong. But, these are the people who gave Andrew Wakefield an award after he was found guilty of multiple ethics violations. What can we expect?

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