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Adverse reaction data for alternative therapies for autism?

21 Sep

Edit–Note that ARI has changed their webpage language:

One factor of alternative medicine is that it is impossible to make an informed decision on risks and benefits. Without data on either, all one has is anecdotes. This is especially troublesome, to me at least, when it comes to risks. What are the adverse events associated with a given alternative medicine treatment? This became clear when an industrial chelator was offered as a “supplement” and the proprietor of that business was quoted as telling his clients to report adverse reactions to him, avoiding the FDA.

The Autism Research Institute (ARI) has promoted alternative therapies for autism for some time, even maintaining a list of therapies with survey results claiming high effectiveness. They also maintain a page on adverse reactions. But without any emphasis on informing people about adverse reactions to alternative therapies.

Here is a quote from that page:

Unfortunately, before the drugs are prescribed to their children, parents are not usually informed of the possible dangers related to the drugs. ARI urges all practitioners to inform their clients about the possible adverse effects associated with every treatment or medication that they recommend to their clients.

Many individuals on the spectrum suffer from seizures, and most of the drugs commonly prescribed to these individuals may lower the threshold for having seizures. We have also listed those drugs that are associated with seizures along with a link.

If your son/daughter experiences side effects from receiving prescribed medications, please contact the FDA at: http://www.fda.gov/medwatch or call 1.800.FDA.1088 (1.800.332.1088).

In addition, parents can learn more about possible side effects, as well as benefits, associated with various treatments by reviewing the results from our parent treatment survey. The survey findings are based on over 26,000 responses, and include a large number of biomedical interventions, including drugs, nutritional supplements, and diet.

One is given the information about how to report a reaction from “prescribed medications”, but not for alternative therapies or supplements. Or so they present it. The page they link to isn’t the direct reporting site. Instead, one must follow a link on that page to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. There you are informed that you may “Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:”

FDA-regulated drugs,
biologics (including human cells, tissues, and cellular and tissue-based products)
medical devices (including in vitro diagnostics)
special nutritional products and cosmetics

emphasis added.

So, the same site where ARI sends people to report “side effects from receiving prescribed medications” can be used (and should be used) to report side effects from alternative therapies which are not prescribed. But parents are not encouraged to make such reports. Which, again, limits the public’s ability to estimate the risks involved with these therapies.

On the ARI page are links to adverse reactions (both ARI’s own discussions as well as links to external sites which publish accepted adverse reaction information) for various therapies. Will you learn about the “occasionally severe” skin reactions that occur with the chelator DMSA? No. Deaths from IV chelation? No. Will you hear about the autistic child who was a test case for the Autism Omnibus Proceeding who appeared to have significant adverse reactions to chelation? No. No one in the public would have heard about that were it not for the Omnibus.

ARI makes a major distinction between “Drugs” and “Biomedical/Non-Drug/Supplements” as therapies. Is this a valid distinction? ARI lists “Transfer Factor” as one of their “BIOMEDICAL/NON-DRUG/SUPPLEMENTS”, claiming that autistics “got better” 5.9 times more often than they “got worse”. But no data on what adverse reactions there are. No links. “Transfer Factor” is not a drug to ARI. It is worth noting that it was a drug to Andrew Wakefield. He attempted to patent Transfer Factor as a therapy and as an alternative to the standard measles vaccine.

The question of whether alternative therapies are presented such that one can make an informed decision is an important one. Raising the question is generally guaranteed to garner the reaction: “he’s anti-cure”, or “he’s against treating autism” or the like. But clearly the argument here is simple: are people being given the ability to make an informed decision about alternative medical treatments used for autism? The answer is simple as well: no. They are not.


By Matt Carey

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.

Defending alternative medicine and autism: the charges against Anju Usman

14 Oct

In Illinois charges DAN doctor with unethical behavior, LBRB writer Ken Reibel discussed the case recently brought against alternative medical practitioner Dr. Anju Usman. These charges follow on a civil suit brought by the parent of an autistic child seen by Dr. Usman. This charges in this case will require that Dr. Usman defend many of the common practices in alternative medicine.

The complaint is:

DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION of the State of Illinois,

v.

ANJUM I. USMAN, M.D.

No. 200904994

One short paragraph in the complaint sums up a big piece of where this suit has the possibility to strongly influence how alternative medicine “treats” autism: None of the treatments described above has been proven to influence the course of autism.

Here is a section of count 1:

17. Hair analysis does not provide a basis for the diagnosis of heavy metal toxicity.
18. Provoked urine testing does not provide a basis for the diagnosis of heavy metal toxicity. The American College of Medical Toxicology has determined that provoked testing has not be scientifically validated, has no demonstrated benefit and may be harmful when used for assessing patients for metal poisoning.
19. Porphyrin testing does not provide a reliable basis for the diagnosis of heavy metal toxicity.
20. Although chelation therapy is FDA-approved for treating lead poisoning, it should not be used unless a non-provoked blood (not urine) test shows an extremely high level of lead.
21. Respondent did not obtain a confirmatory blood lead test or record any source of lead exposure.
22. The record contains no basis for concluding that chelation therapy was appropriate.
23. The record does not contain adequate infonlled consent for any of the prescribed nonstandard tests or treatments. The consent fonns used did not accurately present the risks and/or benefits of tests and treatments. Although it mentioned experimental drug use, these were not administered as part of a proper experimental protocol.
24. The informed consent form states that chelation therapy “is considered controversial for the generalized treatment of chronic low or high level lead toxicity, mercury toxicity, or for other heavy metal toxicities, either acute or chronic.” This statement is misleading because there is a clear scientific consensus that it is inappropriate for treating lead toxicity without demonstrating that toxicity exists and that the level is very high.
25. Throughout the treatment period, Respondent made statements to AC’s mother that the prescribed treatments had positive clinical benefits for children with autism, despite the lack of empirical research supporting Respondent’s position.
26. The record does not document any reason why AC should have received unproven treatments.
27. Spironolactone, which is potentially dangerous, was prescribed without justification.
28. Despite a nonnal selenium level, Respondent repeatedly and unnecessarily prescribed selenium supplements and continued to do so even when AC eventually showed a high level.
29. That Respondent abused the physician/patient relationship by taking unfair advantage of a patient’s vulnerability in that Respondent utilized unproven drugs and medicine to treat AC, a pediatric patient diagnosed with autism.
30. That the foregoing acts and/or omissions of Respondent are grounds for revocation or suspension of a Certificate of Registration pursuant to 225 Illinois Compiled Statutes (2002), Section 60122(A)(20), relying on the Rules for the Administration of the Medical Practice Act, Illinois Administrative Code Title 68, Section 1285.240(b)(1 )(C), and (2) (C).

There are many methods by which “heavy metal toxicity” is diagnosed by alternative medical practitioners. These methods are not demonstrated to be accurate, and are not accepted by actual medical toxicologists. These include hair analysis, provoked urine testing and porphyrin testing.

A prime example is provoked urine testing. A thorough discussion can be found here. A provoked urine test involves giving an individual a chelator and then testing the urine for heavy metals. Everyone (every thing, every animal) has some level of mercury. A chelator will force the body to excrete some level of the heavy metals inside, so it is no surprise that the levels obtained are “elevated”. The problem is that there is no standard by which one can compare the provoked urine to determine if the person actually has heavy metal poisoning.

The method is also called “challenge” testing. The American College of Medical Toxicologists have a position statement on this:

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.

More quotes from the complaint:

From Count III

That Respondent made false or misleading statements regarding the efficacy or value of the medicine, treatment, or remedy prescribed by Respondent in the treatment of any disease or other condition of the body in that Respondent made false or misleading statements regarding the efficacy of chelation therapy in the treatment of autism.

From Count V

29. That Respondent engaged in a pattern of practice or other behavior that demonstrates incapacity or incompetence to practice in that Respondent:
a. Repeatedly prescribed and administered unproven and medically unnecessary treatments to AC despite the lack of empirical research demonstrating the effectiveness of the prescribed treatment plans; and
b. Demonstrated extreme departure from rational medical judgment in the care and treatment of AC.

This isn’t a criminal complaint. Rather it is an ethics or “professional regulation” complaint. The disciplinary action called for if the case is proven involves Dr. Usman’s license:

WHEREFORE, based on these allegations, the Department of Financial and Professional Regulation of the State of Illinois, by Laura E. Forester, its Chief of Medical Prosecutions, prays that the Physician and Surgeon license of ANJUM I. USMAN, M.D., be revoked, suspended, placed on probation or otherwise disciplined.

Illinois charges DAN doctor with unethical behavior

13 Oct

According to the Chicago Tribune, the Illinois Department of Financial and Professional Regulation has charged a well-known Naperville physician with “unprofessional, unethical and/or dishonorable conduct.”

Dr. Anju Usman, a familiar face at anti-vaccine conferences in the US and abroad,   allegedly lied about or exaggerated the value of treatments, and “demonstrated extreme departure from rational medical judgment” and “abused the patient/physician relationship.” Regulators are moving to have Usman’s medical license revoked or suspended, or otherwise disciplined.

The report, written by science writer Trine Tsouderos, says:

The complaint, filed Wednesday, revolves around Usman’s care of a boy diagnosed with autism whose treatment was described in the Tribune’s series “Dubious Medicine.” The series detailed the many unproven therapies prescribed for the boy and found that many alternative treatments for autism amount to uncontrolled experimentation on children.

According to the complaint, the boy began seeing Usman shortly after he was diagnosed with mild to moderate autism in the spring of 2004. He was not yet two.

Usman allegedly diagnosed the child with a calcium-to-zinc imbalance, yeast, dysbiosis, low zinc, heavy metal toxicity and abnormally high levels of aluminum, antimony, arsenic, cadmium, copper, lead, nickel, silver, tin, titanium, and selenium.

Dr. Anju Usman

Usman is the defendant in a civil suit filed by the boy’s father in 2010. Also named are Dan Rossignol, a Florida DAN doctor; and Doctors Data, a Chicago-based laboratory that performs tests used to convince patients that they have dangerously high levels of lead, mercury, or other heavy metals that require “detoxification” to reduce these levels.

Usman is also associated with the 2005 death-by-chelation of five-year-old Tariq Nadama. According to court records, Usman diagnosed the boy with “high aluminum” and referred him to Roy Kerry, a Pennsylvania physician. Kerry, an ear-nose-and throat surgeon, inexplicably treated the boy for lead poisoning.

According to Kerry’s notes, which were published by the Pennsylvania Medical Board:

“We don’t have the entire record at all. Mother left her entire volume of his records home. But we have been in communication with Dr. Usman regarding EDTA therapy. He apparently has a very high aluminum and has not been responding to other types of therapies and therefore she is recommending EDTA, which we do on a routine basis with adults. We therefore checked him to it … But on testing for the deficiency indicator we find him only indicating the need for EDTA at the present time. Therefore we agree with Dr. Usman’s recommendation to proceed with the treatment. She recommends 50mg per kilo. He is 42 pounds today. So we’ll treat him with a 20-kilo child and give 1 gram of EDTA.

Nadama arrested and died in front of his mother during the third chelation round in August, 2005. A year later, Kerry was certified as a DAN doctor after completing an eight-hour training course. Prosecutors declined to charge Kerry for the death, and the state medical board suspended his license for six months and ordered extra training.

Usman spoke at AutismOne in Chicago last May, a cult-like annual gathering that expels skeptical writers and news reporters. Her topic: Prevention & Raising Healthy Kids in a Toxic World.

Generation Rescue: taking another small step away from the brink?

14 Jul

Generation Rescue has over the years been one of the more vocal promoters of the vaccines-cause-autism notion. Like any organization, they have changed over the years and their website reflects that. Their website started out with the title “Autism Mercury Chelation” and a very simple (and wrong) statement:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.

Of course, later during the early years of Jenny McCarthy, when Generation Rescue became “Jenny McCarthy’s autism organization. By this point, GR had a prominent link on the main page to “vaccines”. This included a page with Generation Rescue recommended vaccine schedules. Their “favorite” being a schedule that offered no protection against many diseases, including measles, mumps, rubella, pertussis, diptheria and tetanus.

They had a page of “science”, including statements claiming that Andrew Wakefield’s 1998 paper linked MMR to autism (a position Mr. Wakefield has tried to distance himself from in the past few years):

“This study demonstrates that the MMR vaccine triggered autistic behaviors and inflammatory bowel disease in autistic children.”

They had a science advisory board, which included S. Jill James, Ph.D., Richard Deth, Ph.D., Woody R. McGinnis, M.D. and Jerry Kartzinel, M.D.. Not exactly heavy hitters, but at least a couple of people who actually publish in journals.

Times have changed again. The website is revamped. And vaccines seem to be much less prominent. For example, in the current version of the Generation Rescue website, I can’t find “recommended” vaccine schedules (they refer people to Dr. Bob Sears). A search for Wakefield shows he is only mentioned once “Studies by researchers: Horvath, Wakefield, Levy, and Kushak highlight a myriad of gut problems present in children with autism, including abnormal stool (diarrhea, constipation), intestinal inflammation, and reduced enzyme function”. The science advisory board is down to one person (Jerry Kartzinel) and an unnamed “cohesive group of professionals committed to healing and preventing autism”.

Sure, it’s still not a place I would recommend to anyone, especially a parent who just found out their kid is autistic. But just a few short years ago the trajectory was increasing with the vaccine discussion, not decreasing.

Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

4 May

Dr. Mark Geier is well known in the world of alternative medicine and autism. He, together with his son David, work a medical practice and publish papers. They are long-standing proponents of the vaccine-causation hypothesis, presenting pseudo-epidemiological studies as support. Dr. Geier has worked as a witness in the vaccine court, has has a long history of criticism for his work there.

One of the stranger notions Dr. Geier has put forth involves testosterone. In their model of autism, testosterone binds with mercury in the brain and makes it difficult to remove through chelation. For many, many reasons, this was just plain wrong. Based on their mistaken hypothesis, the Geiers have promoted a treatment for autism based on reducing testosterone in autistic children. In short, they put children on an injected drug: Lupron.

This idea has met with much criticism. Probably no one has studied the Geier’s and their actions more closely than Kathleen Seidel on her blog at Neurodiversity.com. Five years ago and more she exposed the “Lupron Protocol” in a sixteen partseries called

Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol.

Well, it isn’t just one of the best bloggers saying it anymore. The Maryland Board of Physicians has investigated Dr. Geier and Dr. Geier has now had his license suspended.

Here is part of the Order for Summary Suspension:

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial risk of both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The introduction goes on.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and expensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard of quality care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlying medical condition.
The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.
There are no evidence-based studies to support either the Respondent’s Lupron Protocol or his administration of chelation therapy to autistic children; he relies in large part on his own studies which have been wholly discredited by the Institute of Medicine and denounced by the American Academy of Pediatrics. The Respondent’s treatment of autistic children with his Lupron Protocol and chelation therapy is not limited to Maryland. Indeed, in a recent article in the Chicago Tribune, the Respondent stated his intent to open clinics all over the United States, H[w]e plan to open everywhere. I am going to treat as many as I can.

The introduction ends with this paragraph:

The Respondent endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.

Pretty much sums it up. There are numerous counts and details listed in the full document. Below I’ll highlight some specific statements.

Patient A, a child whose mother stated aggression was not a problem, was reported as having aggression and self-injurious behaviors:

Notwithstanding Patient A’s mother’s report that aggression was not a problem with Patient A, the Respondent noted in the “Precious (sic) Puberty Evaluation” section of the form that Patient A, “bites and punches others; hits head with hands.”

As with many (if not all of the children) listed in the order, the diagnosis of precocious puberty was not considered valid:

45. The Respondent misdiagnosed Patient A with premature puberty. Significantly, Patient A did not meet the age criteria for premature puberty.
46. In addition, the results of Patient A’s laboratory studies do not support the Respondent’s diagnosis. The Respondent reported that Patient A’s testosterone metabolites were “significantly increased;” however, the results of Patient A’s luteinizing hormone (“LH”) were only marginally elevated, and his free testosterone and DHEA were within range for a ten (10) year old male.

One question that is often raised with alternative medical practitioners is the validity of their diagnoses. Quite often this involves diagnoses of “heavy metal toxicity” using non-standard tests. In the case of the Geier’s, there is also the validity of diagnoses of “precocious puberty”. There are standards for age, and for tests which should be performed. Reading the order, it is clear that age requirements were often ignored. Bone density tests were often not performed:

The Respondent failed to assess Patient B’s bone age, assess the child’s growth velocity or order a GnRH test to confirm the presumptive diagnosis of precocious puberty.

Also, the signs of precocious puberty could be due to a brain tumor. Yet brain scans were not performed. This from Patient E:

In addition, the Respondent failed to assess Patient E’s skeletal maturation by ordering an x-ray of her left wrist and he failed to order a scan of her brain in order to rule out a tumor.

Another question that often comes up with the Geier practice is what role David Geier plays. David Geier holds only a bachelor’s degree. He is not a physician. Patient C appears to have been examined by David Geier, with Dr. Mark Geier absent:

Patient C’s mother returned to the Respondent’s office on May 19, 2008 because of the worsening of Patient C’s aggressive behaviors. According to her complaint, the Respondent was not present during this office visit, She saw only his unlicensed son.

And, yet, the child was given “comprehensive” abdominal and thyroid ultrasounds at the visit:

The note of the visit indicates that “comprehensive” abdominal and thyroid ultrasounds were performed. Patient C’s physical appearance is described as suggesting “advancement from his chronological age” and that he appeared to be “potentially significantly physically aggressive to himself and/or others.”

and something akin to a diagnosis was rendered:

A portion of the “Psychological Examination” section of the note states, “It is apparent based upon examination of the DSM-IV criteria that [Patient Crs present symptoms are compatible with a diagnosis of pervasive developmental delay – not otherwise specific (sic).”

One problem with research performed by the Geier’s is the lack of an appropriate IRB–institutional review board. Dr. Geier placed himself, his wife and his son on the IRB. Not noted in the Order is the timing of the IRB. If memory serves correctly, there is evidence that the IRB was put into place after research began.

An IRB must consist of at least five (5) members. The ICI IRB’s members include the Respondent, his son and the Respondent’s wife. The ICI IRB is inconsistent with the requirement that a member should not have a conflict of interest in the research project.

The Order includes discussion that “The Respondent [Mark Geier] Misrepresented His Credentials”. When the investigative board interviewed him, here is how Dr. Geier described himself:

On November 6, 2007, in furtherance of the Board’s investigation, Board staff interviewed the Respondent. During the interview, the Respondent stated that he was a board-certified geneticist and a board-certified epidemiologist. The Respondent stated that he had been board-certified in epidemiology in 2007.

However, “board certified” and “geneticist” seem to be incorrect:

As to being a board-certified epidemiologist, this appears to be inaccurate:

166. By letter dated March 29, 2011, the Respondent, through counsel, submitted to the Board a “Fellowship Certificate” from the American College of Epidemiology (“ACE”). The ACE is a professional association whose policy on admission is “inclusiveness.” An ACE fellow is not required to have a degree in epidemiology, a degree in a “related field” is sufficient.
167. The Respondent knew, or reasonably should have known, that he was not board-certified in epidemiology.

As to being a “geneticist”, Dr. Geier is a “genetic counselor”, a different creature:

168. By letter dated March 29, 2011, the Respondent, through counsel, also submitted to the Board a certificate issued by the American Board of Medical Genetics on September 15, 1987 certifying the Respondent as a Genetic Counselor.
169. The term “genetic counselor” is not synonymous with “geneticist.” A geneticist, or medical geneticist, is a physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests. A genetic counselor is an individual with a masters degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.
170. The Respondent knew, or reasonably should have known, that he was not a board-certified geneticist.

Geneticist/genetic counselor and whether he is board certified in epidemiology or not are interesting but minor questions compared to the board findings of misconduct in treating disabled children. So it comes as no surprise that it is ordered:

Based on the foregoing, it is this 27th day of April , 2011, by a majority of the quorum of the Board:
ORDERED that pursuant to the authority vested by Md. State Gov’t Code Ann., § 1 0-226( c)(2), the Respondent’s license to practice medicine in the State of Maryland be and is hereby SUMMARILY SUSPENDED;

Mr. Mark Geier is at present unable to practice medicine in his home state of Maryland.

kathleen Seidel has already blogged this: Maryland Medical Board Suspends Dr. Mark Geier’s License

Chelation: oral not very effective, IV causes brain fog

10 Feb

One very common therapy in the Complementary and Altenative Medicine (CAM) world is chelation. It has been very popular amongst DAN doctors and other CAM practitioners in the autism community, largely based on the mistaken ideas that (a) autism symptoms are similar to mercury poisoning and (b) autism is caused by mercury (from vaccines and elsewhere).

I’ll say it here and I’ll repeat it at the end of this piece: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.

That said, here are two articles I’ve run across recently which reminded me of why people should seek experts. First, the most common oral chelating agent (DMSA, succimer) is not very effective against mercury. Second, IV chelation can result in “brain fog” lasting days.

An NIH Research Matters article titled “Lead Poisoning Treatment Less Effective for Mercury” discusses measurements of blood mercury levels in children in a trial of chelation for high lead levels.

A drug commonly used to treat lead poisoning is relatively ineffective at removing mercury from the blood. The finding provides insight into a compound currently being used as an alternative therapy for autism.

Here are the concluding paragraphs:

A research team led by Dr. Walter Rogan at NIH’s National Institute of Environmental Health Sciences (NIEHS) sought to investigate whether succimer can also remove mercury from the blood. The team used blood samples and data from 767 children, aged 12 to 33 months, who participated in an earlier clinical trial of children who were treated for high blood levels of lead.

The research team measured mercury concentrations in blood samples collected prior to treatment, a week after beginning treatment with succimer or placebo, and again after 3 month-long courses of treatment. The study was funded by NIEHS, NIH’s National Institute for Minority Health and Health Disparities (NIMHD) and the Centers for Disease Control and Prevention. The results appeared online on October 1, 2010, in the Journal of Pediatrics.

The researchers found that, after 1 week, succimer lowered blood concentrations of mercury by 8%. In contrast, it reduced blood lead concentration by 42%. After 5 months, those taking succimer had blood mercury concentrations about 20% lower than the control group. However, the therapy had only slowed the rate at which the children accumulated mercury.

“Succimer is effective for treating children with lead poisoning, but it does not work very well for mercury,” Rogan says. “Although succimer may slow the increase in blood mercury concentrations, such small changes seem unlikely to produce any clinical benefit.”

In an article in Integrative Medicine, Joseph Pizzorno (a leading naturopath) talks about his experience with IV DMPS.

Unfortunately, my first experience with IV DMPS at the normal dosage (250 mg) resulted in significant “brain fog”. I experienced obvious impaired memory and decreased cognitive capacity for several hours (my wife asserts she noticed effects for a full week).

He goes on to tell that even though he believes that overall he is doing better due to lower mercury levels, his team asked him to refrain from IV chelation before meetings. His colleagues were able to see the obvious adverse effects (Dr. Pizzorno refers these as “adverse IV chelation effects”)

I repeat this here: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.