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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.

Bravo Age of Autism

20 May

Yep, you read that correctly.

In a recent blog post on the Age of Autism blog, Dr Lorene E.A. Amet wrote about “Testosterone and Autism”. While much of the piece seems to be fighting a straw man (the theme is that Simon Baron-Cohen wants to use testosterone to screen for autism prenatally–without a link to the story or a quote from SBC, I found this difficult to wade through). But, as part of her piece, Dr. Amet wrote:

It is of great concern that studies on testosterone and autism are being misinterpreted, leading to the use of therapies aimed at disturbing steroid hormone production in individuals with autism. Currently, many autistic children may be being treated, without proof of safety and scientific and medical evidence of benefit, with a view to reducing their hormonal secretion of testosterone (Lupron Therapy, Spironolactone). The rationale behind advocating these therapies appears to be based on a misunderstanding of autistic behaviours and without systematic laboratory evidence of abnormal testosterone levels.

I had to double check that I was reading the right blog! I mean, Age of Autism allowed someone to state that the the rationale behind using Lupron to treat autism is “based on a misunderstanding”.

For those who are lucky enough to not know, Lupron as a treatment for autism is the pet project of Mark and David Geier. These are near heroes to the world of Age of Autism, due in large part to their promotion of REALLY bad epidemiology (for example, here, here and here on Epiwonk’s blog) to support the thimerosal/autism link.

The Geiers took the testosterone theory of Dr. Baron-Cohen and ran with it. Ran without knowing what they were doing or where they were going. Somehow they came to the conclusion that Testosterone binds with mercury in the brain, making it difficult to remove the mercury with chelation. Reduce the testosterone in the system, they guessed, and one could get the mercury out. Since in their world autism is caused by mercury, this will “recover” or “cure” people of autism.

Doesn’t make any sense to you? That’s because it doesn’t make any sense. At all.

Even though the idea of using lupron is misguided and potentially dangerous, that doesn’t mean that the groups that sponsor the Age of Autism blog would be willing to out the Geiers, even without specifically naming them, for the unscientific team that they are.

To be honest, I think the Age of Autism editors just missed that paragraph by Dr. Amet before approving it to be published (if they approve at all).

But, it’s there now for all to read. Bravo Age of Autism. Bravo for joining the world of people who find the Lupron Protocol to be based on a “misunderstanding” of the science.

Mark and David Geier promise its true

4 May

The South Jersey Courier Post carries a story today concerning the father and son team of Mark and David Geier.

They have presented at the branch meeting of the U.S. Autism & Asperger Association concerning their own branch of autism related woo – treatment with Lupron. A process that has led them to stretch the truth beyond breaking point numerous times, claiming false affiliations and using friends and family as members of review bodies in order to pass ethical regulations. In a wider world of autism related woo, this is a particularly sordid story.

The Geiers say excess testosterone increases the toxicity of mercury, which they claim is the primary cause of autism, and that the suppression of testosterone production improves the ability to remove the poisonous mercury — a method often referred to as chelation therapy.

The drug Lupron, or leuprolide acetate, lowers testosterone in autistic children, which then frees up the toxic mercury, the Geiers say. The Geiers, who operate eight offices nationwide under the name “Genetic Consultants,” found that testosterone blocks the body’s ability to make glutathione and that mercury binds to glutathione.

So, the Geier’s are still clinging grimly to the mercury = autism belief. A belief for which there is no sound science whatsoever and so much against it would take too long to discuss in one blog entry.

And 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?

Lupron lowers testosterone and…

To prove there is a hormonal connection to autistic children, the Geiers displayed several studies that showed a major side effect of high testosterone in children is precocious (or premature) puberty. 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.

Weird stats. When I searched PubMed for ‘precocious puberty autism’ I got one result back:

This is a presentation and discussion of clinical and laboratory data obtained on 13 girls with Rett syndrome…..Precocious puberty and respiratory alkalosis were not found in our patients

Huh. Fancy that. Not found. And here the Geier’s are claiming an 80% correlation rate between autism and precocious puberty. Maybe that results from the test they’re using.

The Geiers said they found signs of premature puberty, such as facial hair, body odor and early sexual development…

And yet they somehow failed to perform the very simple and definitive test for precocious puberty – an xray of the wrist. If bone age is one year older than their chronological age then they have precocious puberty. Simple. And not done by the Geier’s. You have to wonder why.

And here we have more hidden science.

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.

Next time someone tells you that ‘big pharma’ are using unindependant research, tell them this: science published in a mainstream journal has its methods and results clearly published so that other scientists can attempt to replicate them. That’s about as independent as you can get. Here we have the Geier’s simply saying these kids improved. No methods, no results, no science is shown. We’re just expected to take their word for it. That’s about as unindependent as you can get. Anyone would think the Geier’s have a vested interest in Lupron doing well.

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