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A Nasty Little Franchise

15 Feb

Wakefield may have the highest public profile but he is just one of many who seek to profit from autism and he is by no means the worst. Remember the Geiers? This father and son team from Silver Springs in Maryland have an unsavoury record that makes Wakefield seem almost reasonable.

Wakefield breached the terms of his hospital’s ethics committee. The Geiers, operating out of the family home, invented their own IRB and granted themselves ethical approval for experiments on children with a powerful drug called Lupron. Lupron is used to treat precocious puberty, a rare condition in young children. It is also used is also used to treat prostate cancer in men, to treat endometriosis in women, and to chemically castrate sex offenders. The Geiers use it on autistic children and young adults.

Kathleen Seidel has catalogued their bad science, plagiarism, inflated academic resumes, the fraudulent IRB, cruel and unnecessary blood draws, attempted deals with TAP pharmaceuticals and the Lupron Protocol itself on her Neurodiversity website. Trine Tsouderos at the Chicago Tribune covers all the basics in her recent profile of the Geiers,  ‘Miracle drug’ called junk science.

The most disturbing part of Tsouderos’ story was the news that the Geiers were rolling out a franchise for others to cash in on their unproven and dangerous protocol. According to their website they offer the following

  • Genetic Markers (DNA Fragile X Syndrome, Blood Chromosome, Chromosome Microarrays, DNA Rett Syndrome, Angelman/Prader Willi Syndrome)
  • Mitochondrial Dysfunction (Carnitine, Lactic Acid, Ammonia, Hand Muscle Testing)
  • Hormone Imbalances (Total Testosterone, Free Testosterone, DHEA, DHEA-S, Androstenedione, Dihydrotestosterone, Total Estrogens, Estrone, Estradiol, ACTH, Aldosterone, Prolactin, FSH, LH)
  • Oxidative Stress/Inflammation (Neopterin, Lipid Peroxides)
  • Detoxification Pathways (Glutathione, Cystathionine, Homocysteine, Methionine)
  • Immune System Function (Immune Deficiency Profile, HLA-Testing, Immune Complexes, Food Allergies, Celiac’s Disease)
  • Heavy Metals (Porphyrins, Blood Metals, Urinary Metals)
  • Neurological Dysfunction (Brain MRI scans, Brain SPECT scans)
  • General Health Status (Comphrensive Metabolic Panel)

And this is the team that will deliver these services.

  • Maryland: Mark Geier MD, geneticist and David Young MD, Obstetrician and gynaecologist.
  • Springfield, llinois: Mary Young MD, psychiatrist and neurologist.
  • Ft. Lauderdale, Florida: David Claymore, neuroradiologist.
  • Parsippany, New Jersey: Paul King, industrial chemist.
  • Indianapolis, Indiana: Melissa Troutman, radiologic technologist.
  • Dallas, Texas: Janet Kern, RN, neuroscientist.
  • Louisville, Kentucky: Janet Pope, RN

And that is it. The only member of the American Academy of Pediatrics is Mary Young who has worked as a child psychiatrist. There are no board certified endocrinologists or anybody with the board certification to diagnose and treat precocious puberty in children.

And what of David Geier BA? He remains vice-president of the non-profit 501(c)3 Institute of Chronic Illnesses, Inc. and the non-profit 501(c)3 CoMeD, Inc. Much of the profit from the franchise will be directed to “these corporations dedicated to
autism research and advocacy efforts.” sure. So families or their insurers will be paying for treatments for their children that have been condemned by real autism experts as junk science. And the profits from this enterprise will be used to fund more junk science. Do they have a GMC in America? Do they want to borrow ours?

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Pity for the Rankins

26 Jan

Its no secret that Wade and I were once pretty good internet pals. We regularly communicated despite our staunch opposition to the others beliefs regarding vaccines role in autism. That changed however as Wade sunk deeper and deeper into the bad science surrounding autism.

Wade and his wife Sym have recently been the subject of a piece by the Chicagoist following Wade’s open letter to the Trib. The Chicagoist reporter (one Mr Carlson) had obviously read both the Trib articles and Wade’s open letter before writing his own piece.

And now Wade has been obligated into writing yet another blog piece as it seems the Chicagoist has taken a similar line to the Trib. Wade says:

Reading through Mr. Carlson’s brief post gave me the distinct impression that somehow the meaning of our letter had gotten lost,

A brief digression. Wade and his family used to live in the South and were affected very badly by Hurricane Katrina. Once the dust had settled they decided to resettle in Chicago. Once there I learned they had become aquainted with the infamous Erik Nanstiel and David Ayoub, both hardcore believers of the vaccine causes autism idea. Not long after that Wade’s own beliefs on the subject hardened and it wasn’t difficult to see where this hardening of beliefs was being hardened from. I found it increasingly difficult to accept the things Wade was saying. An intellegent man, his new beliefs can be summed up in his opinion of Lupron and OSR.

…we have not, as yet, utilized either the Lupron protocol or OSR #1, both of which were the subjects of Tribune smear pieces. That is not to say, however, that those interventions may not be appropriate treatments in particular circumstances. On the contrary, we know families that these interventions have helped…

The old Wade would not have ever considered using these snake oil treatments. The old Wade would not have described the Trib articles as ‘smear pieces’. The old Wade wouldn’t have described knowing families who did use them and would have been much less credulous about their effectiveness.

SO, back to Wade’s statement that he believed the meaning of his open letter had been lost. It was lost, he’s right. It was totally lost on Carlson, it was totally lost on the commenters to the site and its totally lost to people like me. Not that I’m singling myself out for any special praise – thats kind of the point. I’m just an ordinary person with no special agenda and yet Wade’s point is totally lost on me and I very much suspect the vast majority of people who read Carlson’s piece or either of Wade’s long pieces on the subject. (Its hard to say which of the two points of the Somerset Maugham quote Wade utilises for his blog ‘Have common sense and … stick to the point’ that Wade has more strongly abandoned).

I miss the old Wade very much – a strong, principled and funny man, Wade has become just another sad foot soldier in Jenny McCarthy’s Bimbo Brigade alongside his fellow Chicago hardcore believers. His child is 10 years old and I doubt very much that xe is anywhere even approaching the level of ‘cure’ or ‘recovery’ that Wade has been promised by the various DAN doctors and new friends I have no doubt xe has been worked through. Wade’s tone in both of his blog pieces is a sad, tired sort of bewilderment – a bewilderment that the world just can’t see what he can apparently see. Sadly – pitifully – the viewpoint that he has adopted only means he’s going to become more bewildered.

Circling the Wagons

29 May

The alternative medicine community is certainly loyal to their own. This seems especially true in the world of Autism where no idea is ever abandoned, no practitioner ever criticized.

After the Chicago Tribune published articles on the Geiers (and here), as well as Dr. Mayer Eisenstein, it was a forgone conclusion that the community would close ranks.

These articles were published right before the AutismOne conference–which chose to honor Andrew Wakefield after news was released that he may have altered his data. See what I mean? No quicker way to be a hero than to have really the skeletons in your closet made public.

The most basic response was from Kim Stagliano, who let this tweet on Twitter:

From Kim: Chicago Trib is close to dead. Suddenly launches full frontal attack on autism during Autism One. AAP in backyard. They hear us.

Yes, the Tribune is bad and in the pockets of the AAP and the AAP are evil. Please.

Dan Olmsted came out rather quickly with a piece in the Age of Autism blog in defense of the Geiers and Dr. Eisenstein. Later, Anne Dachel did another piece.

Both use a simple contrivance: avoid the real questions raised by the article. Instead, write about “what the Tribune story should have included”. This is especially true of Anne Dachel, who went on and on over pretty much all the media talking points of the vaccines-cause-autism movement.

For example, both Mr. Olmsted and Ms. Dachel thought the Tribune should have discussed Dr. Bernadine Healy. The connection to the story? None. But, Dr. Healy is vitally important to the story Olmsted and Dachel want to tell. See what I mean?

Dan Olmsted’s method sidestepping of the real questions was rather poorly done. In his piece, he writes:

The article lumps Lupron — about which I know nothing, and have no opinion — in with alternative approaches like diet, about which I do know something, and do have an opinion.

Frankly, I found this a ridiculous statement. Dan Olmsted was attending the AutismOne conference–a conference which for years has hosted talks by Mark Geier on Lupron and which Dan Olmsted has attended for years. I guess he missed the Geier talks?

It isn’t as though Mr. Olmsted isn’t able to form an opinion on scant data. Mr. Olmsted has shown a particular interest in Kathleen Seidel–to the point where Mr. Olmsted “diagnosed” her kid with mercury poisoning based on a paragraph in the book Autism’s False Prophets. From only a snippet (wrongly interpreted by Mr. Olmsted) about one of Ms. Seidel’s previous jobs, Mr. Olmsted claimed that she had high levels of mercury, and further stated:

Laugh me off if you want, but I have spent a lot of time looking for plausible links between parents’ occupations and autism in their children, and I know them when I see them.

So, he’s willing to go out on a limb based on a few words in a book, but, say, the page after page that Ms. Seidel wrote about the Geiers and Lupron (e.g. here, here and here) left no impression?

Sorry, Mr. Olmsted. I know ’em when I see ’em too. I see you dodging really tough questions about the Geiers in an effort to protect one of the big names in autism psuedoscience.

To further point out how silly the “about which I know nothing, and have no opinion”, one of the readers of that blog piece pointed out:

Dan, last year AoA published a post from Kent Heckenlively entitled “MERCURY, TESTOSTERONE AND AUTISM – A REALLY BIG IDEA!” In the comments, you said that you had gone to the Geiers’ house and witnessed a child receive a Lupron injection and improve immediately. You “just had to put this on the record,” you said.

I take the fact that Mr. Olmsted has gone from Lupron shill to even this weak distancing himself from Lupron (“I know nothing”) as a good sign. Even Dan Olmsted must be seeing the cracks in the Lupron Logic.

Ms. Dachel does her own “two step” around the question of her real opinion on Lupron.

Let me say that I’m not an expert on any of the medical aspects of this; I’m merely an observer. So here’s what I’m seeing.

Since when does not being an expert on the medical aspects stopped anyone at the Age of Autism blog from making very clear opinionated statements?

But, again, I take the clear signal that she is willing to distance herself from Lupron as a small, but positive sign.

So, let me use their contrivance–let me list what Mr. Olmsted and Ms. Dachel should have written about in their blog pieces. Let me list many of the real questions raised by the articles in the Tribune. As you read this list, it will become obvious why the Olmsted/Dachel tag-team avoided these questions: these are serious questions about people possibly harming children with autism and Dan Olmsted and Anne Dachel don’t have answers to these questions.

At least, they don’t have answers which would satisfy their readership.

Here is the list of questions I had after reading the Tribune articles:

1) Are parents still being sold the idea that Lupron will help remove mercury from their autistic children?

2) Are parents still being told that mercury causes autism? (OK, we all know the answer to that one. The answer is yes. No amount of data will convince Mr. Olmsted.)

3) Are the diagnoses of “precocious puberty” valid? Would a real pediatric endocrinologist agree with the Geier’s assessments? From the Tribune, quoting an actual expert in precocious puberty:

None of the data verify or even suggest that any of these patients have precocious puberty.

4) What is the purpose of all the extra lab tests the Geiers are performing? Are they for the Geiers’ research? If so, why should the parents (or their insurance) foot the bill?

5) Why do the Geiers use 10 times the normal dosage of Lupron?

5) Is Lupron being used as a chemical restraint?

6) Does Lupron even work well enough to warrant its use? Given that Dr. Eisenstein is reported to be close to dropping Lupron, it clearly isn’t a “miracle drug”.

7) what are the side effects of extended use of Lupron. Especially, what are the side effects of wrongly delaying puberty? According to the Tribune story:

Experts in childhood hormones warn that Lupron can disrupt normal development, interfering with natural puberty and potentially putting children’s hearts and bones at risk.

8) Why don’t the Geiers recommend patients to see board certified pediatric endocrinologists?

9) If precocious puberty is so prevalent amongst children with autism, why don’t pediatric endocrinologists see it? According to the Geiers:

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.

10) What about older kids the Geiers are treating? Are they being correctly diagnosed? From the Tribune story:

David Geier said his father diagnoses high-testosterone teens not with precocious puberty, but with another very rare condition: testicular hyperfunction.

How does “testicular hyperfunction” explain the older girls the Geiers have treated?

11) The effects of Lupron on sex hormones are temporary. Stop the shots, the hormones return. The loss of the beneficial effects of puberty are permanent. Does the trade off make sense?

And that is just the list of questions based on the article on the Geiers. Then there is the story about Dr. Eisenstein. This too raises a number of tricky questions.

1) Is Dr. Eisenstein a credible resource for information? After reading the article, one has to question that.

2) Would people like Anne Dachel, Kim Stagliano and Dan Olmsted recommend people see a physician whose malpractice insurance may be “phony”?

In court records dating back three decades, the families of dead and brain-damaged children repeatedly alleged that doctors who work for Eisenstein made harmful mistakes — sometimes the same error more than once. His practice also has been dogged by accusations in court records that its offshore malpractice policy was phony.

3) Would Is Dr. Eisenstein’s record of selling “illegal” health insurance troublesome?

He also dabbled in group health plan sales to Illinois families but tangled with state insurance regulators in the mid- to late 1990s. Regulators warned consumers in a newsletter that Eisenstein “continued to illegally market” the Homefirst Health Plan, based in the British Virgin Islands, even after they told him the plan was ineligible. Despite this, he continued selling the plan, records show, and they ordered him to “cease and desist.”

4) Dr. Eisenstein seems to be good at blameshifting. In this case he accuses the parents of making a mistake that appears to be clearly that of his colleague at HomeFirst. Is this the sort of doctor parents of autistic kids should be seeing?

A Homefirst doctor took a sample of blood from Na’eem’s umbilical cord that could have been used to diagnose the problem and could have led to prompt treatment, according to court testimony. But instead of dropping off the sample at the lab, the doctor said under oath, he was tired, went home and put the sample in his refrigerator, where it sat the whole weekend.

In an interview, Eisenstein blamed the parents for not taking the baby to the emergency room for a blood test. Na’eem’s parents testified that no one from Homefirst ever told them to go to the emergency room.

5) Dr. Eisenstein appears to make some rather questionable decisions about insuring his own practice. Also, it appears from this quote that perhaps he has gone without malpractice insurance. Again, is this the sort of doctor parents of autistic children should be using?

After Nathan Howey’s death, Weiss Hospital sued Homefirst, Rosi and Eisenstein for fraud, alleging they misrepresented their Caribbean-based malpractice policy. Eisenstein testified that he was in St. Kitts helping one of his daughters, a veterinary student there, buy a condo when the lawyer who helped arrange the sale told Eisenstein he also sold malpractice insurance.

“I was tickled pink to get insurance,” he said under oath.

A Cook County judge called it an “improperly underwritten insurance plan.” Eisenstein, who says the policy is legitimate, agreed to pay Weiss $50,000 after mediation.

6) Dr. Eisenstein appears to have inflated his credentials:

Eisenstein said under oath that he was a faculty member at the Hinsdale Hospital Family Practice Residency Program from 1992 to 2003. A hospital administrator testified that Eisenstein “never was” a faculty member. In a recent interview, Eisenstein said that while he wasn’t a faculty member there, he did teach students from that program and kept snapshots of them.

(anyone else reminded of Vera Byers, witness for the petitioners in the Omnibus, who claimed to be faculty at UCSF? In reality, she used the library and attended parties there.)

7) Lastly, is this the type of doctor we should be taking our kids to?

Reflecting on the $1.275 million malpractice settlement, he appeared unshaken.

“It’s the cost,” he said, “of doing business.”

I’m sure the parents were glad to hear that their kid’s life was “the cost of doing business”.

There are a lot of questions raised by these stories. Hard questions. Questions Mr. Olmsted, Ms. Dachel and Ms. Stagliano should answer if they want to really serve their readership.

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.

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.

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