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What has become of Autism Science Digest?

26 Dec

Autism Science Digest was an effort by AutismOne to publish their take on autism science in a magazine format for a general audience. AutismOne is best known for their annual parent convention which focused largely on alternative medicine and vaccine causation.

It is about the time that AutismOne should be publishing their speaker list for next year’s conference so I checked their website. For those interested, the speaker list reads like most past lists.  Andrew Wakefield, the former researcher who promoted the idea that the MMR vaccine causes autism, will speak. So will Keri Rivera, who last year gathered much criticism for promoting forcing disabled children to ingest bleach or undergo bleach laced enemas. Interestingly, neither Mark nor David Geier are on the list. The Geiers have been frequent speakers at AutismOne and other venues favorable to their failed ideas about mercury in vaccines causing autism, as well as bizarre proposals that using drugs to shut down sex hormone production can be used to treat autism.  While not a regular at AutismOne, Luc Montagnier will not make a return visit.  Last year Dr. Montagnier brought the prestige of a Nobel Laureate to the convention. While his presence was touted strongly by supporters of AutismOne, Dr. Montagnier’s ideas were lacking the scientific rigor one might expect from a Nobel laureate (to put it mildly). Of course Jenny McCarthy returns, perhaps to tell us all once again that those who don’t follow her ideas wish for our children to remain disabled so we can bask in the sympathy of our acquaintances.

That all said, while perusing the AutismOne website I noted that the cover for their “Autism Science Digest” hadn’t changed since my last visit.  That was some time ago. The cover informs readers about the then upcoming 2012 AutismOne convention (last April), so my interest was piqued and I checked the page for the “Digest” and found this announcement: Autism Science Digest is temporarily unavailable.

One is left wondering how “temporary” temporary is in this case. Autism Science Digest was launched in August 2011 so the lifespan (should temporary=permanent) seems a bit short.

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By Matt Carey

A multicenter blinded analysis indicates no association between chronic fatigue syndrome/myalgic encephalomyelitis and either xenotropic murine leukemia virus-related virus or polytropic murine leukemia virus

19 Dec

There was much discussion of the possible imprtance of the xenotropic murine leukemia virus-related virus (XMRV) in conditions such as chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME), prostate cancer and autism. To be clear, the possibility of an autism association was made in the press, not in the research literature. For XMRV in general, there was much discussion in the press, in journals and online as it became clear over time that there were possible problems with the analyses that led to the main papers on the topic. The present study includes work by a multi-site team including the principle author of the original study linking XMRV with CFS/ME.

If one can boil a large, multi-site study result into one line, it would be this:

Here, the original investigators who found XMRV and pMLV (polytropic murine leukemia virus) in blood of subjects with this disorder report that this association is not confirmed in a blinded analysis of samples from rigorously characterized subjects

I.e. there is no link between XMRV and CFS/ME.

Here is the abstract, and the full paper is online as well:

The disabling disorder known as chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been linked in two independent studies to infection with xenotropic murine leukemia virus-related virus (XMRV) and polytropic murine leukemia virus (pMLV). Although the associations were not confirmed in subsequent studies by other investigators, patients continue to question the consensus of the scientific community in rejecting the validity of the association. Here we report blinded analysis of peripheral blood from a rigorously characterized, geographically diverse population of 147 patients with CFS/ME and 146 healthy subjects by the investigators describing the original association. This analysis reveals no evidence of either XMRV or pMLV infection. IMPORTANCE Chronic fatigue syndrome/myalgic encephalomyelitis has an estimated prevalence of 42/10,000 in the United States, with annual direct medical costs of $7 billion. Here, the original investigators who found XMRV and pMLV (polytropic murine leukemia virus) in blood of subjects with this disorder report that this association is not confirmed in a blinded analysis of samples from rigorously characterized subjects. The increasing frequency with which molecular methods are used for pathogen discovery poses new challenges to public health and support of science. It is imperative that strategies be developed to rapidly and coherently address discoveries so that they can be carried forward for translation to clinical medicine or abandoned to focus resource investment more productively. Our study provides a paradigm for pathogen dediscovery that may be helpful to others working in this field.

There was a lot of hope in the CFS/ME community that this was a breakthrough that could lead to a treatment. Unfortunately, the answers they seek are elsewhere.

As this is an autism-focused site, allow me to bring this back to autism. Unlike CFS/ME, there were no papers claiming an association between autism and XMRV. Instead there were public comments by the researcher involved and inflammatory journalism. In a search for XMRV autism the first article I get is: Is Autism Associated with A Viral Infection?, by David Kirby published at the Huffington Post. Mr. Kirby’s article was probably the first that pushed the (now failed) XMRV/autism hypothesis strongly into the public’s eye. Mr. Kirby was well known for some time previous for his work promoting the idea that vaccines cause autism. In specific, he was a major proponent of the idea that thimerosal in vaccines caused autism, having published a book Evidence of Harm: Mercury in Vaccines and the Autism Epidemic. For his Huffington Post article on XMRV, Mr. Kirby had some rather irresponsbile speculations from XMRV researcher Judy Mikovits and the founder of her reseach institute Annette Whittemore. From those quotes, Mr. Kirby proceeded to present the XMRV news story in his own way, as a series of speculative questions to create an impression built like a house of cards. The impression he left the reader with was that the XMRV story helped to explain a possible link between autism and vaccines. Following a quoted statement by Mikovits, Mr. Kirby wrote

So there you have it – a possible explanation of regressive autism in a significant number of cases associated with immune system deregulation triggered by vaccination.

Of course, much more work is needed to nail down the exact significance of such an association. For example, is the virus implicated in the cause of autism, or do children harbor the virus as a result of autism?

Notice that he doesn’t say, “much more work is needed to show that this is a real association“. No, rather than stress again that the hypothesis was poorly supported, he jumps to assuming the association and asking what significance it has. Classic David Kirby.

To be fair, the comments by Mikovits and the founder of the research center where she worked (Annette Whittemore) fed directly into his story. To say it again, those statements by Mikovits and Whittemore were irresponsible given the early stage this work was in. But even with those statements, Mr. Kirby had no justification to go into this speculative paragraph:

The discovery raises more questions than it answers. What, exactly, is it about immunization that might switch on XMRV viral expression? Could the effect of heavy metals upon cytokine balances be at play? Where did this retrovirus come from, and how did it apparently become so prevalent in children with autism? Did these children inherit the virus from a parent, or was there some other unexplained route of transmission? Why has the NIH said nothing about XMRV in association with autism, and did Dr. Insel know about these findings without sharing them with the IACC

Again, we see the series-of-questions approach that is Mr. Kirby’s style. He isn’t saying immunization switches on XMRV viral expression (whatever he meant by “XMRV viral expression”. It sounds technical though). He’s posing it as a question. Notice how he brought in his mercury hypothesis, but as “heavy metals”. “Could the effect of heavy metals upon cytokine balances be at play?”. This is a great example of a sciency-sounding sentence that has no substance. Whoever was his editor at the Huffington Post should have shot that back with “do you even know what your talking about here?” But if the editor at the Huffington Post was doing his/her job, this article (and many more by Mr. Kirby) wouldn’t have been published there anyway. It is worth noting that by the time this article was written, the evidence was overwhelmingly against the idea that mercury in vaccines raised autism risk, but this was Mr. Kirby’s way of loosely tying his failed hypothesis to his then current speculation.

To pull the last sentence out of Mr. Kirby’s paragraph: “And why had the NIH said nothing about XMRV?”. Perhaps because they were more responsible than Mr. Kirby.

As a point of fact, XMRV is not prevalent in autistics (Lack of infection with XMRV or other MLV-related viruses in blood, post-mortem brains and paternal gametes of autistic individuals and PCR and serology find no association between xenotropic murine leukemia virus-related virus (XMRV) and autism.) In fact, as will be discussed below, it appears to not infect humans. Unfortunately, Mr. Kirby has not seen fit to post corrections. To the XMRV story or others.

The impression Mr. Kirby created with his story was strong. For example, he gathered 298 comments to his article, largely focused on vaccines. Here’s the last one, prominently at the top of the list:

David: As big as this autism story is, it is only one toe of the elephant. Here is another: There are no protections in place to prevent more XMRV from entering the nation’s blood supply. There is as of yet no XMRV screening test for donated blood. And — I just called my local Red Cross – there is as of yet nothing to prevent people diagnosed with CFS from donating blood. We are all at risk.

The elephant: How did our government let this potentially deadly retrovirus spread unchecked for twenty-five years? XMRV has, so far, now has been found to occur in people with autism, lymphoma, a severe form of prostate cancer, atypical MS, ME/CFS, and fibromyalgia. Twenty-three years ago the CDC was first informed of an outbreak of what we now know to be an XMRV-associated local epidemic. Eighteen years ago a study showed a retrovirus was associated with ME/CFS.

The band played on.

Yes, let’s spread fear about the blood supply, based on news reports, speculation and bad science.

Some of the authors of this present XMRV and CFS/ME study were also involved in a separate major multisite study on MMR and autism. I am referring to a study intended to replicate the key findings of some of Andrew Wakefield’s research. That study, by Mady Hornig, W. Ian Lipkin and others, Lack of association between measles virus vaccine and autism with enteropathy: a case-control study been re-interpreted by some as supporting Mr. Wakefield’s work. Some have gone so far as to claim that Mr. Lipkin’s team is signalling support for Mr. Wakefield’s work by citing it in other studies. It’s a stretch, a mind boggling stretch, and it’s wrong.

From the CFS/ME paper:

Sensitive molecular methods for microbial discovery and surveillance have enabled unique insights into biology and medicine. However, increased sensitivity for bona fide signal increases the risk that low-level contaminants may also be amplified. This can lead to spurious findings that pose challenges for public health and require an expensive and complex pathogen dediscovery process. Examples wherein authors of this paper have been engaged in this process include refutation of associations between enterovirus 71 and amyotrophic lateral sclerosis (24) and MMR vaccine and autism (25).

Lipkin and Hornig consider their work to be a “refutation” of the association between MMR and autism. But don’t take that one sentence from the paper as the only proof. Here’s an interveiw with Prof. Lipkin at Nature.

Had we done this when Andrew Wakefield [the former medical researcher who proposed that autism was caused by vaccines] came out with the initial report about the measles, mumps and rubella (MMR) vaccine and autism, and had something this definitive, there are many more children who would have been vaccinated against measles during the ten years it took us to finally complete the MMR–autism work. So I think it’s crucial that we don’t do things in a half-baked fashion, so we can test hypotheses and move on to new ones.

The interviewer even includes the MMR refutation as part of a question: “You have disproved the autism–MMR connection and other controversial disease links.”

In general, what can one say about XMRV? Aside from the drama involved in the story (which I did not discuss in detail in this article), and the questions about CFS/ME, autism, prostate cancer and more, what can we say? Prof. Lipkin says it very clearly in the interview:

We did not find any genetic sequences [of XMRV or related viruses] in the people with CFS or the controls. As far as we know, there is no human being that is infected with XMRV.

But there were papers (some now retracted) claiming some links between XMRV and human disease? What about those? Another quote pulled from the interview:

I think the explanation is that there was contamination. I don’t see any reason to invoke anything beyond that.

For this you have to give Judy Mikovits some credit. She worked with the team that was attempting to replicate her results. Contrast this with, say, Andrew Wakefield. A man whose hospital offered him the opportunity to replicate his own results, and he quit rather than accept that offer. A man who has repeatedly denied the science which has been clearly against his hypothesis. A man who denies the fact that he acted unethically in many ways in conducting his research. Judy Mikovits made some mistakes, both scientific and socially, but she seems to be part of the solution.

But that’s a bit of a sideshow. The main conclusion is that XMRV is not involved with autism. Or, apparently, any human disease.

With apologies for revisiting David Kirby and Andrew Wakefield.

—
By Matt Carey

AAP opposes worldwide ban on thimerosal

17 Dec

In a series of articles released today, the American Academy of Pediatrics outlines its opposition to a proposed UN treaty which, if approved, would ban the preservative thimerosal from vaccines worldwide. The ban is also opposed by the World Health Organization and the US Public Health Service. It is estimated that multidose vaccines with thimerosal as a preservative are used in 120 countries to immunize approximately 84 million children, saving about 1.4 million lives each year.

The AAP’s opposition reverses the professional organization’s call in 1999 for the removal of thimerosal from the US pediatric vaccine schedule. That action is frequently cited by anti-vaccine groups as evidence that health officials know that vaccines cause autism and other neurological conditions. But Dr. Louis Z. Cooper and Dr. Samuel L. Katz, co-authors of  one of today’s articles, directly take on that concern:

Had the AAP (and, we suspect, the USPHS) known what research has revealed in the intervening 14 years, it is inconceivable to us that these organizations would have made the joint statement of July 7, 1999. The World Health Organization recommendation to delete the ban on thimerosal must be heeded or it will cause tremendous damage to current programs to protect all children from death and disability caused by vaccine-preventable diseases.

The 1999 domestic ban surfaced during a Nov. 29 congressional hearing on autism, where representatives of both parties repeated long-debunked anti-vaccine talking points. Rep. John Tierney (D-MA) asked the CDC’s Dr. Colleen Boyle why thimerosal was taken out of childhood vaccines if there were no concerns about its safety. Boyle wisely agreed to get back to him with an answer. An anti-vaccine hearing is no place for reasoned discussion.

In another article, researchers Katherine King, PhD, MSc; Megan Paterson, and Shane K. Green, PhD; reaffirm that “there is no credible scientific evidence that the use of thimerosal in vaccines presents any risk to human health.” They continue:

Extensive pharmacologic and epidemiological research has shown early, theoretical concerns about links to autism or other neurodevelopmental disorders to be false. Indeed, the exculpatory strength of the data now available on thimerosal is well evidenced by recent statements from the Global Advisory Committee on Vaccine Safety, US Institute of Medicine, and American Academy of Pediatrics, all of which have concluded that thimerosal exposure through vaccination is not harmful to human health.

The AAP’s latest action is a shot across the bow to anti-vaccine groups. The UN’s proposed thimerosal ban has been championed by Mark Geier, the disgraced Maryland geneticist best known for chemically castrating disabled children. Two years ago, he told a group of African delegates gathered for a session of the Intergovernmental Negotiating Committee in Japan that thimerosal “is favored by the pharmaceutical industry because it is cheap and enables the industry to keep making vaccines in old and dirty factories.”

Geier is a regular at Jenny McCarthy’s annual anti-vaccine conference, where he receives standing ovations from anti-vaccine parents. Ten states have either revoked his medical license over the last two years, or allowed it to expire, for Geier’s ethical lapses which included lying about his qualifications risking children’s health with unproven medical treatments.

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By AutismNewsBeat

Controversial autism doctor Mark Geier loses licenses in Missouri, Illinois

4 Nov

Mark Geier has been discussed a great deal here on Left Brain/Right Brain. Including very recently on the topic of this article. Much of that discussion has recently centered on his belief that not only is autism caused by mercury, but that mercury somehow is bound to testosterone and that by reducing the amount of testosterone in the body one can reduce the amount of mercury and, thus in his flawed model, treat autism. Mr. Geier’s clinical practice was found to have been flawed as well and he lost his license to practice medicine in his home state of Maryland. He was licensed in multiple other states as well, including Missouri and Illinois. With the loss of his license in Maryland, other states have followed in license actions.

The St. Louis Post Dispatch reports: ” Controversial autism doctor Mark Geier loses licenses in Missouri, Illinois”.

Todd W. Of Harpocrates Speaks writes about this in “Mark Geier on his Last Leg” where he notes that Mark Geier is still licensed in Hawai’i only.

Todd W. keeps a map of states where Mark Geier has lost his license.

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By Matt Carey

Mark and David Geier, holed up in Missouri?

5 Oct

There is really no fun in writing about people whose lack of ethical standards harm disabled children. Seriously, it is painful. I know at least one autism blogger who quit in no small part because it was just too hard to keep writing about these topics.

And here in one week, both Andrew Wakefield and the Geiers (Mark and David) come back up in the news. A recent story in the St. Louis Post Dispatch discusses the Geiers: Controversial autism doctor loses license elsewhere, but can still practice in Missouri, Illinois

Mark Geier is an M.D. and was licensed in multiple states (I’ve lost count of how many and which ones). His home base is Maryland. His license was suspended there and many other states have followed suit. David Geier holds no medical credentials and is charged with practicing medicine without a license in Maryland.

As noted above, most, but not all, states have followed suit with suspending Mark Geier’s license.

The St. Louis Post Dispatch writes (reminding me of which states Mr. Geier has been licensed):

Dr. Mark Geier has opened eight autism treatment clinics called ASD Centers across the country but is only allowed to practice at two of them — in St. Peters and Springfield, Ill.

Missouri and Illinois are among the last states to seek discipline against Geier, whose hormone therapy for children with autism has been called dangerous, abusive and exploitive by various medical boards.

In the last two years, his medical license has been revoked or suspended in California, Florida, Indiana, Kentucky, Maryland, New Jersey, Texas, Virginia and Washington.

Missouri, Illinois and Hawaii have filed complaints against Geier based on other states’ actions, but his license remains active in all three states. A disciplinary hearing in Geier’s case is set for Oct. 19 before the Missouri Board of Registration for the Healing Arts in Jefferson City

The Geier hypothesis is that mercury binds with testosterone in the brain, making it difficult to chelate. They prescribe Lupron to reduce testosterone. The idea would be laughable if it weren’t being used on humans (or any animal for that matter).

Briefly–the Geier’s cited a paper showing that in hot benzene,
(more details in Miscellaneous Mercury Nonsense), mercuric chloride and testosterone can be induced to form chemical complexes.

I had hopes that the Geiers had moved away from this idea, but they stand by it:

David Geier said Wednesday that “many peer-reviewed scientific studies” have been published that support the theory. All of the research articles cited on the ASD Centers’ website are co-authored by Mark or David Geier.

The fact that the Geiers were able to get papers published in third rate journals doesn’t make their ideas true. Or even feasible.

Mr. David Geier did not attend medical school. Neither did I but I will offer him this small bit of medical advice: Among other logical problems with your idea, the human brain is not the same thing as a beaker of hot benzene.

Point two: even if your idea held any merit, Lupron lowers the level of testosterone in the blood, it doesn’t break up these mythical mercury-testosterone complexes.

The Geiers are demonstrating a major problem with the medical license system in the U.S.. It took years to bring the Geiers to hearing. Now that Mark Geier has lost his license in his home state, he has moved to other “safe havens” to continue business? How is this right.

I recall a number of med students and premeds I knew while in college and grad school. The hoops they had to jump through to get their degrees and get licensed and start working seemed enormous. Now we see why: it’s so hard to stop someone from practicing.

Mark Geier’s license suspended in Florida, revoked in Indiana

22 Aug

Dr. Mark Geier is well known within the alternative-medicine and vaccine-causation segments of the autism communities. As a practitioner, Dr. Geier is probably best known for therapies purporting to treat autism through approaches claiming to work on removing mercury. The idea that mercury is involved in autism etiology is a failed hypothesis on it’s own. But Dr. Geier’s treatment ideas included a frankly incredible notion that mercury is bound in the body by testosterone, so, he hypothesized, by reducing the body’s production of this hormone, one could better remove the mercury. To reduce testosterone, Dr. Geier proposed (and prescribed) drugs such as Lupron. It is not a bad idea–it is a series of bad idea. Very bad ideas.

These ideas are so poor in concept that it is difficult to get insurance companies to pay for Lupron for reducing mercury in the body. In an apparent move to avoid this difficulty, Dr. Geier diagnosed autistic children with precocious puberty. Dr. Geier’s methods were lacking and due to this and other factors, Dr. Geier’s license came under suspension in his home state of Maryland.

Dr. Geier was licensed in many states. When a doctor faces disciplinary action in his home state, he is supposed to report those actions to other states where he holds a license. As Catherina reports in Bad month for the Geiers: Mark R. Geier’s medical license suspended in Florida, Dr. Geier appears to have failed to inform Florida in a timely manner. The full decision is linked on the Just the Vax site, and also can be found here.

Todd W. of Harpocrates Speaks further notes that Dr. Geier’s license had been revoked–not suspended, revoked–in Indiana. In Mark “Castrate ‘Em” Geier’s License Suspended – Part 7 Todd W. notes:

Indiana also made a further step, going beyond mere suspension to actually revoking his license in that state. The revocation comes because he failed to appear before the board regarding his suspension, thereby defaulting on any appeal to their decision. The final order, dated July 5, 2012 further imposed a $5 fee and a fine of $3,000.

Further reading about the “Lupron Protocol” can be found at Neurodiversity.com, where Kathleen Seidel’s thorough reporting was the first to expose many of the questionable practices.

If I understand correctly, Dr. Geier remains licensed in both Illinois, Missouri and Hawai’i. However, he faces more charges in his home state of Maryland.

Missouri notes the fact that Dr. Geier has faced license suspension in other states. His license is up for renewal there Jan 31, 2013. In Illinois, his license is active, with a notation that he has not been “ever disciplined”. His license comes up for renewal there July 30, 2014. His Hawai’i license is “current, valid and in good standing” and valid through 01/31/2014.

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by Matt Carey

(note, the last paragraph was added shortly after this article was published)

David Geier ordered to pay $10,000 for practicing medicine without a license

13 Aug

David Geier is the son in a father-son team which ran a clinic purporting to treat autism through such unproven and biologically implausible methods as chelation and lupron.  In addition, the team produced questionable quality research promoting the link between autism and vaccines.  While Mark Geier holds an M.D., David Geier holds no degree nor other qualifications in medicine.

The Maryland State Board of Physicians charged Mr. Geier with practicing medicine without a license and, recently, the board found him guilty and fined him $10,000. Mr. Geier has the right to appleal. More details can be found in the Board’s order.

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by Matt Carey

Scientist Patricia Rodier, Trailblazer in Early Origins of Autism, Dies

19 Jul

Autism researcher Patricia Rodier, Professor at the University of Rochester, has died. U. Rocherster discusses this on their website as Scientist Patricia Rodier, Trailblazer in Early Origins of Autism, Dies.

Patricia Rodier, Ph.D., the first scientist to formulate and study the idea that autism can originate long before a child is born, died May 3 at Strong Memorial Hospital. She was 68.

An embryologist specializing in the nervous system, Dr. Rodier completely changed the way we think about the development of autism. While many believed that the disorder arose very late in pregnancy or in the early part of an infant’s life, Dr. Rodier’s research turned that widely held, but unproven, belief upside down. Her work established that genetic and environmental factors can also spur the development of the disorder as early as three weeks into a pregnancy, when the first cells of the nervous system start to develop.

Prof. Rodier became interested in autism relatively late in her career, but early in the modern era of autism research: 1994. She heard about a study showing a high prevalence of autism in adults who had been exposed to thalidomide prenatally. She gathered a team to investigate how autism develops early during gestation.

She wrote an article in 2000 for Scientific American, The Early Origins of Autism (also available online in full here). A lot has happened in autism research since then, but much of what she did and had to say is very relevant today. For example, she performed research using post-mortem brain tissue. She notes that the twin studies, even those available at the time, showed that more than simple inheritance was at play. She notes multiple prenatal environmental exposures which increased autism risk (thalidomide, maternal rubella infection and valproic acid). She notes how the data, even then, pointed to multiple genes being involved.

In short, many ideas which are considered “new” (e.g. multiple genes as a risk factor) or that “mainstream medicine refuses to consider” (e.g. environmental risk factors) are discussed in that 12 year old article.

Another part of Prof. Rodier’s research which became extremely relevant in the discussion of autism causation was her work on mercury exposures. From the U. Rochester webpage:

A professor in the Department of Obstetrics and Gynecology at the University of Rochester Medical Center, Dr. Rodier was also a world expert on mercury toxicity, studying how single exposures to the chemical during pregnancy influence a baby’s brain development. To this day, much of the research being done on mercury exposure and birth defects is based on Dr. Rodier’s early findings.

She was likely the one person in the world who had strong expertise in both autism development and mercury. She was called upon as a witness for the Omnibus Autism Proceeding (discussed here and here). Her expert report for the OAP is an excellent resource for people trying to make sense of the autism/mercury notion.

I exchanged emails with Prof. Rodier a few times to discuss her work. While I never actually spoke with her, the “voice” of her emails was always very kind. I found out about her passing when I was considering contacting her again recently. I wish her family well.

–by Matt Carey

Lupron, soon to be a patented autism treatment?

1 Jun

Lurpon and similar drugs are used to reduce the production of sex hormones in the human body. These drugs are used to treat prostate cancer, uterine fibroids and precocious puberty. In the autism community, Lupron came to prominence as an alternative medical treatment for autism. The theory, put forth by father and son team Mark and David Geier, was that mercury in the brain was bound to testosterone, making it impossible to remove by chelation. By reducing the amount of mercury

The Geiers filed a patent for their idea. Here is the abstract for that patent application:

The present invention relates to methods of treating a subject diagnosed with autism or an autism spectrum disorder, lowering the level of mercury in a subject determined to contain a high level of mercury, methods of lowering the level of mercury in a child diagnosed with autism, lowering the level of at least one androgen in a subject diagnosed with autism, lowering the level of mercury and the level of at least one androgen in a subject diagnosed with autism and methods of assessing the risk of whether a child is susceptible of developing autism.

And their first claim (claims are the heart of a patent and claim one is the most important):

1. A method of lowering the level of mercury in a subject suffering from mercury toxicity, the method comprising the steps of:

a) administering to said subject a pharmaceutically effective amount of at least one luteinizing hormone releasing hormone composition; and
b) repeating step a) as necessary to lower the level of mercury in said subject.

Yes, it was all about mercury.

Well there’s good news and bad news on this front. Good news is that the patent office saw through the mercury angle. Bad news is that the patent application is still alive.

The original patent application had 109 claims. The first claim for the original application is above.

Here’s the new claim 1 (in case you want to skip the long paragraph of legalese, note that mercury is not mentioned):

1. A method of treating a subject suffering from autism, the method comprising the step of: a) administering to the subject a pharmaceutically effective amount of at least one luteinizing hormone releasing hormone composition to treat the autism, wherein the at least one luteinizing hormone releasing hormone composition is administered in a sufficient amount and over a sufficient period of time to control clinical symptoms of autism to a desired level, and wherein when the subject is younger than 18 years and said luteinizing hormone releasing hormone composition comprises leuprolide acetate, and the subject is administered a dosage of the composition of at least about 20 ug/kg per day for at least 28 days or said leuprolide acetate dosage is administered via a slow release formulation that releases said leuprolide acetate daily dosage over a 28 day period, and wherein when the subject is 18 years old or older than 18 years said luteinizing hormone releasing hormone composition comprises leuprolide acetate, and the subject is administered a dosage of leuprolide acetate of at least about 0.3 mg per day for at least 28 days or said leuprolide acetate dosage is administered via a slow release formulation that releases said leuprolide acetate daily dosage over a 28 day period.

Yes, claim 1 is very different. In fact, the patent application now has only 30 claims. None of which mention mercury. It’s a good guess that the patent examiner rejected a lot of claims.

The rest of the patent still has a great deal of mercury discussion. Patent examiners don’t usually require changes to the body of the patent, just the claims. The body included this statement:

It is known in the art that mercuric chloride binds and forms a complex with testosterone in vitro and possibly in subjects (See, Cooper et al., “The Crystal Structure and Absolute Configuration of the 2:1 Complex between Tesosterone and Mercuric Chloride,” Acta Crystallogr B., 1968, 15:24(7):935-41).

This was their “sheets of mercury and testisterone” theory. They showed that in the literature there is evidence of mercury binding to testosterone. Trouble for their theory is that the paper cited involves mixing mercury with testosterone in a beaker of hot benzene. The idea that this same process happens in the human brain was an amazing stretch of logic.

One of the many incredible leaps if logic in their story.

I don’t think either the Geiers or the patent examiner have spent much time at all on the body of the patent. Here’s a typo that’s propagated through multiple iterations of the patent over many years:

Today, humans are exposed to mercury from a variety of different sources, including dental amalgams, certain industries such as battery, thermometer and barometer manufacturing, ingestion of certain foods such as fish and shellfish, environmental pollution resulting from the use of fossil foods, prescription medicines, and from vaccinations and other biologicals, such as Rho immune globulin, containing thimerosal, a mercury-containing preservative.

Emphasis mine

Somewhere over the years they might have picked up on “fossil foods”, one would think.

The bottom line is that the Geier lupron protocol patent application is still alive, albeit in a much reduced form. If I recall correctly the manufacturer of lupron had a stake in the patent as originally submitted but they have transferred their stake to the Geiers. Apparently the company decided to get out of the lupron-for-disabled-children business.

The Geiers are left with the patent and whatever future royalties it would bring. Which I doubt will be much. It would be interesting to see how many of there talks fail to mention their financial stake, though. Are they informing parents and the doctors they are pitching this idea that they stand to make money off this?

Also of interest are the case histories included in the patent. At least one child had no indications that lupron was required. This is exactly the sort of practice that resulted in Mark Geier’s license suspended.

Lupron and similar drugs are powerful medicine. They have legitimate uses. When dealing with children it only seems prudent to work with a pediatric endocrinologist. One has to ask why the Geiers don’t refer children to the appropriate specialist. The sad answer is that pediatric endocrinologists probably would reject the diagnoses given by the Geiers.

Congressman Dan Burton: It is time to re-engage on the autism epidemic

25 Apr

Dan Burton is a U.S. Congressman, a legislator elected to represent the state of Indiana to the U.S. House of Representatives. Mr. Burton was once a frequent name in the discussion about autism. His grandson is autistic and Mr. Burton championed the idea that mercury, in specific the vaccine preservative thimerosal, was a possible cause of autism. Mr. Burton hosted congressional hearings on the matter which fueled the discussion. Much of this is documented in David Kirby’s 2005 book Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy.

When Congressman Burton was holding meetings In the early 2000’s, there was not a great deal of scientific data on the idea that mercury could be behind an autism epidemic. There was correlation–autism prevalence estimates by various sources showed rising rates coincident with the increased exposure from infant vaccines during the 1990’s.

But this isn’t the early 2000’s. A lot has been learned since Mr. Burton held his hearings. And the knowledge gained points away from thimerosal as a cause if autism Mr. Burton himself is set to retire this year. Yesterday Mr. Burton wrote about his previous efforts and a new initiative he has proposed in a blog article: It is time to re-engage on the autism epidemic. And by epidemic, Mr. Burton appears to mean the failed mercury-induced-autism-epidemic. From his article:

Unfortunately, a great deal of misinformation has been thrown around in public and private about the Committee’s focus on mercury in medicines as a possible factor in the autism epidemic. I’m not a scientist, but the Committee heard from many credible scientists and experts who are convinced that mercury is a contributing factor; and the theory is no less worthy of exploration than the theories being propounded today that the pregnancy weight of the mother or the age of the father at conception influences whether a child becomes autistic. When you have no idea what is causing a disease, policymakers and scientists should never be afraid to investigate any plausible theory. In fact, researching possible environmental factors is a central component of today’s research on autism.

Mr. Burton’s attempt to compare the mercury hypothesis to recent results falls flat. For one thing, there is evidence that factors such as parental age may increase the risk of autism. Multiple studies indicate increased risk. On the other side, there is no real evidence to suggest that mercury increases the risk of autism, and a great deal of evidence to the contrary.

As already noted: a lot has been learned since Mr. Burton held his hearings 10 years ago. But today, as it was 10 years ago, scientists and policymakers are not afraid to investigate the hypothesis that mercury caused an autism epidemic. We’ve seen paper after paper come out of those efforts. Accepting results is not fear. Far from it.

Mr. Burton states:

The other issue we dealt with is how do we help the millions of individuals and families afflicted with this disease. Autism has no cure and it is not a life-threatening disease. That means that the autistic children of today will be the autistic adults and autistic seniors of tomorrow. Our nation is ill prepared to deal with the complex challenges posed by a generation of autistic individuals.

It strikes this reader that the leadership of the past, which certainly includes Congressman Burton, was afraid to tackle a basic question: what is an accurate count of the number of autistic adults? The autistic children of yesterday *are* the autistic adults of today. How many are there? What do their living conditions look like? What successes and failures can we learn from the lives of those autistics, and the way the rest of society supported them? What health issues are there for autistics as they age?

The sad fact is we don’t really know.

Some researchers in the U.S. have looked for, and found, misdiagnosed autistics in some populations. The U.S. has mounted a project to explore autism prevalence and other issues in older cohorts, but that work has just begun. Researchers in the U.K. have delved into the questions of adult prevalence and living conditions, five years ago.

The U.S. is ill prepared, and precisely because of the leadership Mr. Burton offered. Instead of accepting even the possibility that there were misdiagnosed or undiagnosed adult autistics, attention was focused on asking the same question again and again: is mercury behind the rise in autism prevalence? Time and again the answer came back no.

And, now, we are going to ask yet again. Mr. Burton mentions in his article a bill he sponsored: H.R. 3489: White House Conference on Autism Act of 2011. Yes, a bill from last year. It was introduced to committee on Nov. 18th of last year and has had no action since. In other words, a bill which is all but dead.

The bill calls for a conference. A meeting. To generate a report. The conference has no charge other than this. It is reminiscent of Mr. Burton’s hearings. People gathered. People were selected specifically to speak based on their views that mercury could cause autism. Reports were generated. This is action? Leadership?

Who will be a part of this conference? Mr. Burton’s bill spells out who should be a part of this committee:

(1) at least 1 shall be a parent or legal guardian of individuals with autism or other pervasive developmental disorders;

(2) at least 1 other shall be knowledgeable about autism intervention programs and systems, including complementary and alternative therapies;

(3) at least 1 other shall be knowledgeable about programs specifically designed to meet the unique educational needs of children and adults with autism;

(4) at least 1 other shall be knowledgeable about programs specifically designed to meet the unique housing needs of children and adults with autism;

(5) at least 1 other shall be knowledgeable about programs specifically designed to train and educate law enforcement and criminal justice officials to respond to the unique needs of children and adults with autism; and

(6) at least 1 other shall be knowledgeable about environmental or toxic exposure of adults and children as it relates to the development of autism.

A lot has changed since Mr. Burton held his first hearings on autism. One thing that has changed: autistics have rightfully fought for and won the right to be represented in autism discussions. Mr. Burton’s bill does not represent that shift.

Mr. Burton’s words do not acknowledge that the question of whether there was a mercury-induced-epidemic of autism has been answered.

Let’s put it simply. Mr. Burton: the answer is no. Thimerosal didn’t cause an autism epidemic.

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