Search results for 'lupron'

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.

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Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

20 May

The father-son team of Mark and David Geier have been charged with violations of medical practice. Mark Geier is a physician and his son, David, holds a bachelor of arts degree. Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine is the most recent post by Kathleen Seidel of Neurodiversity.com. This follows the suspension of Dr. Mark Geier (Maryland Medical Board Suspends Dr. Mark Geier’s License).

Ms. Seidel’s post follows her practice of a very thorough, well linked discussion of the topic. Here is her first paragraph (without links):

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

It is well worth the time to read the entire post: Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

Is lupron just a chemical restraint?

26 May

Since it was first proposed by Mark and David Geier, Lupron therapy for autism has been criticized heavily. Do a google search–if your results are like mine, the first hit is a blog post by Kathleen Seidel “Playing with Fire“. Ms. Seidel has done much to expose the questionable methods used by the Geiers to promote Lupron as a therapy for autism. Her list of Lupron links is quite valuable for anyone considering this therapy. Top amongst those is a blog post by Prometheus at the Photon in the Darkness blog, exposing the questionable science behind the supposed testosterone/mercury connection.

Lupron is a drug which shuts down sex hormone production in the body–temporarily. Because of the hormone reduction, lupron is used in the treatment of prostate cancer in men and fibroids in women. The only approved use for children is to treat “precocious puberty”–i.e. the onset of puberty too early. It is useful because it temporarily reduces hormone production.

But, that isn’t what the Geier’s proposed. They didn’t start out to treat precocious puberty. It is worth looking at the history to see how much the Geiers’ stories have changed. There appear to be three stories now.

Story one: mercury binds to testosterone making it difficult to chelate out of the brain. The science backing this up was ridiculous (unless you think your brain is a vat of boiling benzene). Seriously, I am embarrassed for the Geiers. Even in the world of alternative medicine, this was junk science.

Story two: autistic kids almost all have “precocious puberty”. Odd that no one else has ever seen this, but it gives a medical reason to prescribe Lupron (one that will pass insurance scrutiny).

But, both “story one” and “story two” seem to be in the past. Yes, there is mention of precocious puberty in the recent articles in the Chicago Tribune (‘Miracle drug’ called junk science). But, here is a paragraph worth reading:

By lowering testosterone, the Geiers said, the drug eliminates unwanted testosterone-related behaviors, such as aggression and masturbation. They recommend starting kids on Lupron as young as possible and say some may need the drug through the age of puberty and into adulthood.

Does that sound like (a) they are treating mercury poisoning or (b) they are treating precocious puberty?

Here is a quote from Anne Dachel’s rather weak defense of the Geiers:

One of the issues in the stories is the use of Lupron to treat aggression in autistic children who have high levels of testosterone. This is a huge controversy. The treatment is slammed as “unproven and potentially damaging” in the Tribune.

Does that sound like (a) they are treating mercury poisoning or (b) they are treating precocious puberty?

The Rev. Lisa Sykes, in the comments to the Tribune article wrote:

As the parent of the first child to be treated by Dr. Geier for high testosterone, a condition caused by cinically diagnosed mercury-poisoning from the theraputic use of vaccines and RhoD, I can only wait for the day the press gets it right.

Does that sound like (a) they are treating mercury poisoning or (b) they are treating precocious puberty?

Remember, this is the same Lisa Sykes whose video interview promoting Lupron talks about finding a way to get the mercury out. But, now it is “high testosterone”. Sure, she asserts (without any support) that this is caused by mercury poisoning. Anyone want to guess who “clinically diagnosed” the mercury poisoning, by the way? I know who my money is on.

Before I go too far off track, let’s bring this back to the big question–if the story is no longer “mercury poisoning” or “precocious puberty”, is Lupron being used for any other purpose than controling behavior through limiting testosterone levels? And, at 10 times the normal dosage used for precocious puberty, isn’t this a rather handed approach?

Lupron has been called a “chemical castration” drug due to the fact that it shuts down the body’s testostoerone production and has been used to control behavior in sexual predators. Lupron obviously will have profound effects on the behavior of people–children or adult, autistic or not.

If testosterone control is the real purpose for the “Lupron Protocol” (as the Geiers have named it) shouldn’t we then ask: isn’t this just a form of restraint?

Keep in mind, Lupron only works temporarily. Stop giving the Lupron shots and testosterone levels will rebound. Remember this quote from the Tribune story?

They [the Geiers] recommend starting kids on Lupron as young as possible and say some may need the drug through the age of puberty and into adulthood.

Anyone remember how the “mercury toxic” children idea was perpetuated? Since standard tests don’t show high levels of mercury, “challenge” chelation tests were used. When real toxicologists test children shown to be “mecury intoxicated” by alternative medical practitioners, the real answer is no mercury poisoning. Is the same pattern happening in the world of testosterone testing?

Let’s check the patent application the Geiers’ submitted. The first patient mentioned in the application is “child X”. Child X had serum testosterone levels of 25ng/dL. The reference range was 0-25ng/dL. In other words, the kid was within normal ranges.

How about the other patients? Child Y, for instance? Again, within normal ranges.

Child Y’s total serum testosterone was determined to be 20 ng/dL. The reference level of total serum testosterone for a male child of Child Y’s age at this laboratory was from 0-20 ng/dL.

“Child A” was slightly above normal ranges.

Laboratory analyses for androgen metabolites revealed an elevated serum total testosterone=23 ng/dL (age- and sex-adjusted LabCorp reference range=0-20 ng/dL)

Child B was higher than the reference ranges.

Laboratory analyses for androgen metabolites revealed an elevated serum testosterone=18 ng/dL (age- and sex-adjusted LabCorp reference range=0-10 ng/dL)

Now, here is one that amazes me:

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.

It doesn’t appear to matter. If a child is within the reference range, slightly above, or above, the answer is the same: treat with Lupron.

So, I again pose the question: is Lupron a chemical restraint? I will add a further question: is it being applied to children whose testosterone levels are not high?

Why lupron “franchises” for autism?

25 May

You know how it is when you read a story filled with red flags. A lot of them are obvious and hit you right away. Others sit in the back of your brain until enough pieces are put together and the idea springs forward, “that’s what’s wrong!” Such was the case with the Tribune stories on the Geiers and their “Lupron Protocol”. The high costs were an obvious red flag. I mean, $12,000 in tests and $6,000 a month in prescriptions? But, one red flag that took a while to process was the existence of the “franchises”. From the Tribune story:

…the Geiers have opened eight clinics in six states, including one in Springfield and their arrangement with Eisenstein, which he described as a “franchise” of sorts.

and

Some of the Geiers’ clinics are headed by doctors; a psychiatrist runs the Springfield clinic. But that is not always the case. The clinic in Indianapolis is run by an X-ray technologist who has an autistic child.

In Washington state, the head is a health advocate and documentary filmmaker.

OK, the existance of “franchises” run by x-ray technologists and documentary filmmakers is a pretty clear red flag.

But, take a moment and recall: what is the Geiers’ rationale for prescribing lupron? The answer: the Geiers claim that autistic children have a very high incidence of precocious puberty. They are not treating autism, they say. No, they are treating the precocious puberty, with Lupron, a drug which reduces testosterone production in the body. At least, this is what they tell the insurance companies in order to get reimbursements for the parents.

Recently it hit me. Why the franchises? Precocious puberty is diagnosed and treated by pediatric endocrinologists. Heck, pediatricians can do an initial diagnosis.

Is there a shortage of pediatric endocrinologists in, say, Chicago? (I counted 12 in that list in Chicago proper).

If this were really about autistic kids almost all having precocious puberty, Dr. Geier’s talks would have one simple tag line: Get your kid to a to the nearest pediatric endocrinologist for a full work up.

Instead, his message seems to be: call me (someone who doesn’t specialize in pediatric endocrinology) or wait until I establish a franchise in your home town.

That would be one giant red flag for me if I were considering using the Geiers.

The high financial cost of Lupron therapy for autism

24 May

Lupron therapy for autism has been controversial ever since it was first proposed by Mark and David Geier. Controversial–as in the rational for Lupron for autism was based on some of the worst junk science I have ever seen. Neurodiveristy.com has followed Lupron since the beginning (here is but one example of the excellent reporting from neurodiversity.com).

The Lupron story recently was covered by the Chicago Tribune. Page 1 of the Trib, by the way. The story was the number 1 emailed story from the Trib’s website when I checked at one point. Even with letting the Geiers give input for “balance” it was still a very scary story.

One thing that caught my eye was the very high cost of Lupron therapy. At least, the very high cost when Lupron is prescribed by the Geiers and used to “treat” autism (or, as the rationale goes, autistic kids with precocious puberty).

First, the cost for testing is very high. From the Tribune:

To treat an autistic child, the Geiers order $12,000 in lab tests, more than 50 in all. Some measure hormone levels. If at least one testosterone-related level falls outside the lab’s reference range, the Geiers consider beginning injections of Lupron. The daily dose is 10 times the amount American doctors use to treat precocious puberty.

Second, the cost of the drugs was even higher. Again from the Tribune article (quoting Mark Geier himself):

The cost of the Lupron therapy is $5,000 to $6,000 a month, which health plans cover, Mark Geier said. However, two families told the Tribune that they had trouble getting insurance to pay for the treatment.

These numbers seemed so high that I decided to ask someone who would know. Someone who treats children with precocious puberty.

How much does it cost to test for precocious puberty? $12,000 as when the Geiers are testing? Not even close. According to my source, precocious puberty can be diagnosed for less that $1,000 in tests.

It appears that the Geiers call for a lot of tests that are not involved with precocious puberty.

So, how about that $5,000 to $6,000 a month that Dr. Mark Geier says his patients (or their insurance) pay for the therapy? How does that compare to an actual treatment for precocious puberty? At doses typically used for precocious puberty, $1,500….a year.

Yes, $6,000 a month if you are with the Geiers vs. $1,500 a year for a real precocious puberty therapy.

Something seems really wrong here. It doesn’t appear as though the Geiers are dispensing the Lupron themselves. Parents seem to be getting Lupron from pharmacies. If so, the increase is not due to any markup by the Geiers.

Recall from the quote above from the Tribune:

The daily dose is 10 times the amount American doctors use to treat precocious puberty.

This might account for the cost going from $1,500 a year to $15,000 a year. How can the Geier protocol cost $60-72,000 a year?

Should the Geiers be granted a patent on Lupron?

22 May

As many in the autism community will tell you, drug patents are big money. Usually this is used by people claiming, “he is not trustworthy–he makes a lot of money off of drug patents”. Funny how those claims aren’t applied to the father-son team of Mark and David Geier, who have applied for a patent for their method of “treating” people with autism using a very strong drug that dramatically reduces the levels of the hormone testosterone in the body.

This “protocol” has been called into question in recent articles in the Chicago Tribune, here and here. These stories have been blogged on LBRB by Kev and myself.

As an aside, at the time of writing, one of the Tribune articles is #5 on the Tribune’s “most viewed” list, and #1 on the most emailed list.

The Geiers originally looked to Lupron with the justification that somehow testosterone was binding with mercury in the brains of people with autism. This made it difficult or impossible for chelating agents to remove the mercury. Since, in the world of Mark and David Geier, mercury is at the root of autism, it made sense to get rid of the testosterone in order to treat the mercury poisoning in order to improve or recover the autistic person.

Sound convoluted and implausible? You are right.

First off, autism isn’t mercury poisoning. Geez, that’s one dead horse that will never be given a rest.

Second, Lupron shuts down production of testosterone. It does not remove testosterone from the system. Who is to say that reducing the amount of testosterone in the system would break up the supposed “crystalline sheets” of mercury/testosterone compound that the Geiers believe are in the brains of autistics?

Third, even the Geiers don’t buy into the mercury/testosterone connection (at least in public). Read the Tribune stories. All the discussions are about reducing the amount of testosterone in the body.

The Geier’s patent application, US27254314A1, has 109 claims (a lot!). What is claim #1 (the most important claim in any patent)?

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.

I.e. they are patenting using Lupron (and similar compounds) to help remove mercury from people.

If they aren’t actually reducing mercury, or treating people with “mercury toxicity” (isn’t the real term intoxication?), why should this be granted?

The Geiers may state that they see behavioral differences in their patients. Well….they are reducing their testosterone levels to near zero. Of course they will see behavior differences. But, are they, as they claimed, reducing the mercury levels in their patients? If you read the article, you will see that mercury really isn’t discussed. It is all about reducing testosterone levels.

How does the Reverend Lisa Sykes, co-author with the Geiers on papers, and parent of probably the Geier’s most well known patient have to say? In the comments on the Tribune website, she states:

As the parent of the first child to be treated by Dr. Geier for high testosterone, a condition caused by cinically diagnosed mercury-poisoning from the theraputic use of vaccines and RhoD, I can only wait for the day the press gets it right.

Yep. The story has changed. The good Rev. Sykes, who used to claim that the idea behind lupron was to get the mercury out, now claims that mercury causes high testosterone levels. Well, at least they are consistent in always making mercury and vaccines the villan.

So, again, I pose the question: if Lupron isn’t working by helping to remove mercury, should the patent be granted to the Geiers? From where I sit, the answer seems to be a clear, “No”.

Of course, a second question is “does it have any benefit for people with autism”? The Geiers recruited Dr. Mayer Eisenstein to “treat” people with autism using Lupron in the Chicago area. After a few months of being part of the Geier “franchise”, what does Dr. Eisenstien have to say?

“It’s highly unlikely that we’re going to be part of the autism program much longer,” Eisenstein said. “I’m not pleased enough with it. It’s not where I want to put my energy.”

I just don’t see this patent as being granted.

Does the Lupron Protocol hurt us trying to get insurance parity?

22 May

One of the big issues in the US autism community today is the quest for insurance coverage for autism. Many states are considering or passing laws right now on this very issue.

One question that comes up is how to address alternative medicine. Lawmakers don’t want to make an autism diagnosis a free pass to any and all therapies–be they real, experimental or bad.

So, take a look at the “Lupron Protocol”. This was discussed in a recent article in the Chicago Tribune.

For those who have been lucky enough to not hear about the Lupron Protocol, here is a brief history.

Professor Simon Baron-Cohen proposed a theory that autism might be caused by exposure to higher than normal levels of testosterone in the womb.

Mark and David Geier took this this idea, mashed it up a lot and mixed it with their concept that autism is caused by mercury. Their theory? Mercury binds with testosterone in the brain, forming crystalline sheets which are difficult to remove with chelation.

Utter and complete nonsense.

The Geiers then proposed that reducing the amount of testosterone in the system would allow chelators to access the mercury. They had found a way “to get the mercury out”. Removing the mercury, according to them, would result in improvement or recovery from autism.

Utter and complete nonsense.

Fast forward to today. The Geiers have set up “franchises” across the country to “treat” autistic kids with Lupron, a drug which shuts down testosterone production in the body.

Utter, complete and scary nonsense.

Insurance companies won’t pay for this. For one thing, they don’t usually pay for experimental therapies. Calling the Lupron Protocol “experimental” is just wrong. Experiments are controlled. The subjects are informed that the therapy is experimental and there is some oversight and there is an actual study going on. At best one could call the Lupron Protocol “alternative” medicine.

Or, one could call it, utter, complete and scary nonsense. Just my personal opinion.

Since the insurance companies will not pay for nonsensical autism therapies, the Geiers have decided that autistic kids have a very high incidence of early onset or “precocious” puberty. They test for this:

To treat an autistic child, the Geiers order $12,000 in lab tests, more than 50 in all. Some measure hormone levels. If at least one testosterone-related level falls outside the lab’s reference range, the Geiers consider beginning injections of Lupron. The daily dose is 10 times the amount American doctors use to treat precocious puberty.

$12,000?!? I am trying to find out from a reputable source how much the tests to determine precocious puberty really should cost.

Note that they do a LOT of tests. If they get any single test which indicates precocious puberty, they diagnose and start treatment.

I am not alone in questioning these tests. Experts in precocious puberty have questioned them as well. From the Tribune story:

The blood tests the Geiers use as proof of excessive testosterone don’t show that at all, and other data they cite mean nothing, said Paul Kaplowitz, chief of endocrinology at Children’s National Medical Center in Washington, D.C., and an expert on precocious puberty. They also leave out test results that could help show whether the children are in early puberty, he added.

Looking at the tests, Kaplowitz said he asks himself: “Is Dr. Geier just misinformed and he hasn’t studied endocrinology, or is he trying to mislead?”

If the tests cost $12,000, how much do you think the treatment costs?

The cost of the Lupron therapy is $5,000 to $6,000 a month, which health plans cover, Mark Geier said. However, two families told the Tribune that they had trouble getting insurance to pay for the treatment.

Yep, $60,000 plus per year. Again, I am trying to find out how much a legitimate course of Lupron should cost. Also, I am very interested to know how long a course of Lupron should take. Should it go on indefinitely, as apparantly the Geier protocol does? Or, is there some finite time involved?

Given the opinions of the actual specialists interviewed by the Tribune, it seems pretty clear that the Geiers are neither treating mercury poisoning nor precocious puberty. What they are doing is charging for a lot of expensive tests and even more for a long regimen of Lupron.

Is it any wonder that the insurance companies are balking?

Is there any question that this will make it harder for the rest of us to get real insurance parity for people with autism?

Lupron called ‘Junk Science’

21 May

It was only a matter of time before the big papers caught on to some of the quack treatments being pedalled by certain (in)famous autism doctors.

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,” (said Professor Simon Baron-Cohen)

“It has become a cottage industry of false hope, and false hope is no gift to parents,” said Autism Science Foundation President Alison Singer, whose daughter has autism. “A lot of these therapies have no science behind them. You are using your child as a guinea pig.”

I blogged earlier this month about the Geier’s at a conference and their totally unsubstantiated claims at this conference:

they are also claiming that they have ‘found that testosterone blocks the body’s ability to make glutathione’. Searching PubMed for ‘lupron glutathione’ returns no hits at all. So where have they found this? Under the stairs? Why aren’t they publishing this science if they’re so sure?

The Geiers said they found signs of premature puberty, such as facial hair, body odor and early sexual development, in 80 percent of the autistic children in their clinic.

Which is yet another unverifiable statistic. A search of PubMed reveals just one study relating to precocious puberty and autism and that showed _no_ link.

Mark Geier said laboratory tests at his clinic show that after just three months on Lupron, autistic children improved in dozens of cognitive and behavioral ways. This just seems another figure pulled out of thin air. Theres nothing anywhere to support such an idea and if they’re so sure why haven’t the Geier’s published?

“In terms of science, there is nothing suggesting the most basic elements of what they are talking about,” said Tom Owley, director of the Neurodevelopmental Pharmacology Clinic at the University of Illinois at Chicago and a specialist in the treatment of autistic children with medicine. “That there are high levels of mercury in autism — not proven! That they have precocious puberty — not proven!”

Hilariously…

Mark Geier responded that these are “opinions by people who don’t know what they are talking about,” saying the pediatric endocrinologists interviewed by the Tribune don’t treat autistic children and have not tried the Lupron treatment. David Geier said prominent scientists support their work and gave as an example Baron-Cohen, the autism expert who told the Tribune that the Geiers’ Lupron treatment filled him with horror.

So Mark Geier is either a liar or badly informed. I know what my opinion is.

AutismOne – the huge Chicago based autism woo fest kicks off today and the Geier’s are scheduled to talk about their miracle drug. They’ll be talking largely to people already sold on the idea that screwing with their kids bone density and hormonal growth is a good thing as long as it helps with their kids autism. Trouble is, it doesn’t.

Creatinine, Chelation and Lupron…Oh my!

6 Jun

A recent news segment on NBC in America covered Chelation therapy as a treatment for autism. The response was as predicted. The pro-cure/biomed side went into raptures. Everyone else winced. As a UK resident I have to say that (sorry America) this seems to be a furtherance of the dumbing down of science in the US that has led to both this sort of report appearing on a serious news show and the joke of creationism being taught in science classes.

Anyway, thankfully, these types of things are still viewed by most people (over there and over here) as marginal and not representative of the truth. However, that doesn’t negate the fact that there is a lot of experimentation going on by so called ‘scientists’ and by some parents. My favourite quote so far from some retorting to the Dateline segment is:

A treatment used prior to proof is called an experiment.

ACSH.

So what can be said to be poorly understood and yet still be used?

Lupron for Autism

I recently had an interaction with a number of people on an Autism Biomed board after they stated that Lupron was ‘working miracles in recovering my child’. At least one of these people was someone who had assured me about a year ago that chelation was ‘working miracles in recovering my child’. A part of me fully expects to hear that car battery acid is ‘working miracles in recovering my child’ from the same person a year from now. After that? Tongue of Toad? Eye of Newt?

It was clear that the ‘scientists’ advising these people had not informed them of basic facts about the condition that was allegedly affecting their kids autism. Neither of them had had their childrens hand and wrist radiographed which is the standard way of determining if a child is undergoing Precocious Puberty or not. Basically, If bone age is within 1 year of chronological age, puberty has not started. If bone age is advanced by 2 or more years, puberty likely has been present for a year or more or is progressing more rapidly.

The single most basic fact about Precocious Puberty is that it is immediately subdivided into Central Precocious Puberty (CPP) or Pseudo Precocious Puberty (PPP). It is vital to make this difference as the treatment is different in each division. The division can only be made by testing for premature activation of the hypothalamic-pituitary-gonadal axis. When I asked one of these people if the Geiers (yes, it was they) had subcategorised into CPP or PPP they did not know what I was talking about. They were entirely ignorant of these terms. It was clear neither of the two people I had spoken to had undergone this sub-categorisation.

They claimed it was ‘enough’ to ‘know’ that their children had excess testosterone. One of these children is female. This child’s parent was utterly ignorant of the fact that excess testosterone in females was not called ‘precocious puberty’ but indicative of ‘Androgen excess’. Lupron is not mentioned as a treatment for Androgen Excess.

One other interesting fact about increased testosterone is that in patients diagnosed with PPP, this can result from an excess of vitamins and other dietary supplements. Its common knowledge that this is a common part of DAN! and DAN! style treatment regimes. Yet again, the Geier’s patients parents were entirely unaware of this fact.

Sources

http://www.emedicine.com/ped/topic1882.htm
http://www.emedicine.com/PED/topic1881.htm
http://www.androgenexcesssociety.org/signs.html
http://www.healthatoz.com/healthatoz/Atoz/ency/sex_hormones_tests.jsp

The Role of Creatinine in Relation to Porphyrins and Chelation to Creatinine

I’m not going to go over this subject as well as Not Mercury recently did but I want to highlight a few key concepts from that paper that it seems the authors either missed or didn’t account for.

The paper’s essence is that it is significant the their are elevated levels of Porphyrins in autistic kids. However, they fail to account for the likelihood that this is a false elevation. The study attempts to measure the amount of porphyrins in the urine of their subjects. However, because collecting urine of a standard volume, content and dilution is next to impossible, its necessary to use a stable compound to express the porphyrins as a ratio of – which is where creatinine comes in. So, the paper claims that, relative to creatinine, porphyrins are high in autistic kids.

However, as Not Mercury also highlights, its fairly accepted amongst DAN! practitioners:

Creatinine is often found to be marginal in the urine of autistics, and low creatinine can skew urine analyte results to high levels. So, also take note of creatinine levels if the laboratory results include ratioing to creatinine.

PDF translated to HTML from ARI

And Andrew Wakefield’s colleague, Paul Shattock, also reports low creatinine in autistic kids (see source on Not Mercury blog entry). So why does that matter? Now, I’m no scientist so I was struggling to find a way to visualise this in my head and I came up with the bar chart below. The thin black line is an arbitrary ‘baseline’ (where the creatinine stops and the Porphs start) below which in purple is creatinine levels and above which is Porph levels. Now, in the autistic representation note how the decrease in creatinine has led the baseline measurement for Porph to falsely raise the amount of Porphs. In other words, relative to the baseline, there are not more Porphs as such, but less creatinine. I’m open to interpretation on this by the way – I don’t want it to be misleading.

There are also anecdotal reports of various chelators reducing creatinine further:

my son’s creatinine has come down to 11 by round 3. why is it going down?how can i bring it back to normal? i have been giving glycine to him also during rounds – every 3hrs dmsa+ala

Onibasu.

And:

Importantly, recent data suggest that oral NAC administration > transiently lowers creatinine levels.

PubMed

So here we seem to have a situation wherein autistic children are already noted to have low creatinine levels and that these levels could be even further reduced by the chelators used either in the study itself or by parents externally to the study and still the study authors claim it is significant to epxress Porphs _as a ratio_ of creatinine.

Autism One

Meanwhile, over in Chicago, Autism One has been in full force (or should that be farce?). I’m reliably informed that one of the big draws was David ‘crowd pleaser’ Kirby so I downloaded his slides to have a looksee.

Incredibly, it seems that David Kirby has magically ‘forgotten’ everything he conceded to blogger Citizen cain regarding the use of CDDS data. Lets remind ourselves of what Kirby told Citizen Cain:

…if the total number of 3-5 year olds in the California DDS system has not declined by 2007, that would deal a severe blow to the autism-thimerosal hypothesis. He [kirby] also conceded that total cases among 3-5 year olds, not changes in the rate of increase is the right measure….

And yet, here we have slides showing Kirby demonstrating the change in the rate of increase, something he has conceded is inaccurate as a measure. He also refers to the increase in cases as ‘new’ cases when its been demonstrated time and time again that these are _not new cases_ . All in all, this is simply more dishonesty from David Kirby.

Autism and autistic people deserve better than this hodge-podge of sloppiness and dishonesty.

Lupron: An Alternate View

17 Mar

I think it was Prometheus who first used the phrase:

You can’t reason someone out of a belief they haven’t reasoned themselves into.

By which he meant that proponents of the mercury/autism hypothesis were acting out of belief, innuendo and poor science rather than scientifically valid science and that subsequently trying to use reason to dissect their arguments was of limited use.

What I intend to do in the rest of this post is use the tactics, sources and methods commonly used by proponents of the autism/mercury connection to justify their belief systems. before I do I want to assure you that _nothing_ in this post is fabricated.

As we all know, Lupron has been big news recently. The Geiers love it, the mercury/autism crowd are clamouring to use it and the likes of Orac, Kathleen, Autism Diva, Prometheus and myself have all blogged comprehensively against its use.

However, we were using science and reason and as we know, there are people who are impervious to these things. However, when I received a fascinating email from a middle aged American woman who wanted to talk to me about Lupron I read her words with interest. As all proponents of the mercury/autism hypothesis know, anecdotes trump science. With that in mind I read her opening statement.

I am extremely concerned about the use of the drug Lupron being used on autistic children. As a former consumer of this drug, I can tell you firsthand how harmful it is. I understand the desperation people may experience trying to do all they can to heal their conditions, but we must not forget that Lupron is actually chemotherapy, and leaves the same conditions other forms of chemo do on patients. You wouldn’t give chemo to someone who didn’t have cancer, so how Lupron made the jump to all these other patient groups is purely manufactured by Abbott Labs, the parent of TAP who makes Lupron.

Lupron is chemotherapy. Lupron is manufactured by Big Pharma’s TAP – owned by Abbot Labs. A little digging on the Internet turns up lots of bad things about Abbot Labs:

ABBOTT LABS OBESITY DRUG KILLS 32 PEOPLE AND IS PULLED OFF THE MARKET IN ITALY

Source.

Abbott Laboratories, the world’s 12th largest drug company, has been suspended for a minimum of six months from membership in the Association of the British Pharmaceutical Industry (ABPI).

Source

If there was ever any reason to squash human beings like a bug, the decision makers at Abbott Labortories have provided a perfect one with their decision to increase the cost of the anti-AIDS drug Norvir by 500% (from $1500 to $7800 per year).

Source.

Thats just the tip of the iceberg. My anonymous emailer continued….

Any child already harmed by vaccinations does not deserve a second pharmaceutical insult, which is what Lupron will
do. TAP/Abbott is a filthy company, and thinks nothing about the harm they do to patients. It was just published how 800 people have died from another drug they make.

Pretty convincing stuff, I think you’ll agree. Its obvious that Lupron is manufactured by the same sort of bottom-feeding evil scum Big Pharma types that inject autism-causing thiomersal into healthy babies. My anonymous emailer continued:

It just horrorfied me to read about these kids being encouraged to take this drug. Do you know, there was a National Lupron Victims Network with over 2 million hits that suddenly just disappeared off the net? The data is on Way Back Machine or Archive.org under “lupronvictims.com”. We have Abbott employees who follow us around the internet trying to discredit us. It’s like science fiction.

So I checked it out – the domain ‘lupronvictims.com’ was registered in August of 1999 and is hosted by Forest a Seattle company – the same city that the domain registrant specified. I’ve sent an email to the admin contact at Forest to enquire about why the site vanished in early 2005 but have thus far recieved no reply.

As proponents of the Simpsonwood conspiracy will readily recognise, this reeks of corruption and Big Pharma meddling.

The site is indeed archived on the WayBack Machine but fascinatingly, even though the Way Back Machine continued to archive up until March 2005, one has to go back to late 2003 to find actual archived content. the most complete archive is the first one from 1999.

And still my anonymous emailer had more to say:

Whether this happens to all patients I don’t know, but I do know there are many, many people living in hell from using it. Some of us have contracted terrible deseases from having our immune system compromised, and we all battle many diseases: CFS, Fibromyalgia, EBV, arthritus, severe memory problems, clinical depression, liver problems, high cholesterol, trabecular bone loss creating disc herniation and osteoporosis, etc.

She also mentioned the name ‘Lynne Millican’:

In 1999 I went public in the Boston Herald with my story trying to prevent more poisonings. One person, Lynne Millican, has testified before the senate. We have fought and fought to bring awareness to no avail.

A quick search reveals some impressive sources:

When we first met Lynne Millican in January, when this series on Lupron was launched, we learned that she still suffers a range of serious ailments more than a decade after injections of the drug, Lupron, for treatment of endometriosis. Millican, a registered nurse and paralegal, believes her problems are associated with Lupron. Millican’s numerous symptoms have included the development of a noncancerous tumor, breast cysts, cardiac arrythmias, pain, dizziness, swelling and fatigue. She is one of many women treated for endometriosis who have complained over the years about these and other lingering symptoms they believe are related to Lupron. Other symptoms include depression and confusion, bone pain, vision loss, high blood pressure, and nausea.

Red Flags Weekly

“There are thousands in the United States who say they have been victimized by this drug,” Millican said, emphasizing that symptoms can be severe, such as tremors, seizures and memory loss. “Many women I know say their symptoms didn’t stop when they stopped taking the drug.”

Mercola

Proof indeed. My anonymous emailer closed with the following:

They just got bagged doing the same dirty tricks in England that they were levied the largest fine in US History for doing
here. They have so much money they just pay everyone off. Get the word out. Prevent more poisonings because the FDA does not care.

I think supporters of the thiomeral/autism connection will testify to the truth of that. The FDA are in the pocket of Abbot Labs, Big Pharma Agents of the Apocolypse.

Truly, its stupid to put Lupron into kids. When their bodies start to break down, we can all march on Washington – the placards will read ‘It was the Lupron, stupid’.

No need for science. No need for investigation. As a regualr commenter here says ‘Because its obvious…’