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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5 Responses to “Lupron, soon to be a patented autism treatment?”

  1. Audrey June 4, 2012 at 13:48 #

    I am very interested in articles like this, but I have a favor to ask the mods. Like many people with ASD, I have trouble with sarcasm, especially over the internet which removes nonverbal cues. The title of this article suggested to me that the Lupron protocol was likely to get its patent, whereas the text of the article made it clear that the patent was very unlikely to be granted. Bearing this in mind, would it be possible for you to write headlines that are more literal? Even a change as simple as “Lupron, soon to be a patented autism treatment? Unlikely” would really help me a lot.

    • daedalus2u June 8, 2012 at 14:54 #

      Audrey, This Lupron patent could very well issue. Having a patent doesn’t mean a technique works or is of value, it only means that it is new and that the patentee claims it works. The patent office takes what ever the applicant says at face value.

      I think there is a very good case for a patent issuing on using Lupron to treat autism, not because it has any shred of credibility or any chance of working, but precisely because it is so implausible that no one else has even conceived that injecting children with a chemical that severely interferes with their regulation of steroid synthesis could possibly help with autism.

      The prior plausibility of Lupron being helpful in autism is extremely low. There is essentially no data that supports such a thing and much data that says it won’t help. The only proposed mechanism (that testosterone binds mercury in sheets), is completely non-physical and has no supporting data. There are no animal studies showing that Lupron aids in the chelation of mercury in experimental animals.

      There probably is enough “evidence” for a patent to issue, the only burden of proof is that no one else has suggested using Lupron to treat autism earlier. You could probably get a patent on using plutonium to treat autism because no one has considered and published such a thing.

      While there is enough “evidence” for a patent to issue, there is no where close to enough evidence to justify using Lupron in children, even in clinical trials to see if Lupron does affect autism. There is a much higher burden of proof to test things in humans. There needs to be sufficient evidence of benefit that the potential benefit outweighs the potential harm. There simply is no credible evidence of potential benefit of using Lupron in autism. There is lots of direct evidence of harm due to disruption of steroid physiology.

      I think that is why the manufacturer of Lupron has distanced themselves from the Geiers. The manufacturer is the deep pocketed entity in this fiasco, when there are lawsuits filed over the use of Lupron in autism, the manufacturer will be named as a defendant in the lawsuit.

  2. Sullivan (Matt Carey) October 4, 2016 at 19:29 #

    Wow. Barry Segal’s org is still debating whether lupron is a viable autism treatment.

    https://www.focusforhealth.org/looking-at-lupron-is-it-safe-to-change-your-childs-path-through-puberty/

    It isn’t.

    Focus for Health relies upon Brian Hooker for autism input. Hooker is a supporter of the idea that mercury in vaccines causes autism. He’s also right with the Geiers, who promoted the lupron scam on the autism community. So this blog post by Segal’s org isn’t surprising.

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