Why not just castrate them? (Part 2): The mainstream media finally notices the Geiers’ Lupron protocol

I originally joined this wild and woolly collective known as ScienceBlogs back in February 2006. I was not part of the very first wave of bloggers who made up ScienceBlogs when it launched, although I potentially could have, mainly because I had to work out policies about outside employment with my university before I could join up. In any case, one of the very first posts that I did back then that made a bit of a splash was a little ditty I called in my usual inimitable and restrained fashion, Why not just castrate them?

It was the dark saga of an even darker father-and-son tag team of quacks named Mark and David Geier. Dr. Mark Geier is a physician but has no expertise in pediatrics, endocrinology, vaccines, or autism. His son only has a bachelor’s degree in biology; yet he assists his father in his “research” and in essence helps him treat patients, despite his lack of medical training. Together, they are the Batman and Robin of autism woo (the 1960s camp version, not the updated Dark Knight version) going into battle against autism, which–surprise! surprise!–they blame on vaccines. But not just any vaccines. Oh, no. Batman and Robin–excuse me, Mark and David–were there at ground zero of the formation of the mercury militia. Indeed, even though numerous studies have exonerated the mercury in the thimerosal preservative, in particular the fact that over seven years after it was removed from childhood vaccines other than the flu vaccine new autism diagnoses have shown no signs of decreasing, the Geiers cling stubbornly to the belief that even Generation “autism is a misdiagnosis for mercury poisoning” Rescue has backed away from lately, namely that autism is caused by mercury in vaccines.

Not that the Geiers didn’t put their own personal spin on things. As Kathleen Seidel wrote about first and I commented on later, the Geiers came up with a “hypothesis” (my fingers seized up as I typed that, not wanting to dignify their idiotic idea with such a scientific term) that testosterone somehow bound to mercury, making it harder to chelate. They even claimed that testosterone binds to mercury and forms “sheets” in the brain, leading to a complex that can’t pass the blood-brain barrier and keeps mercury in the body, a complex that the quackery known as chelation therapy won’t chelate. They claimed that autistic children were really undergoing premature puberty and had too much testosterone. So what was their solution?

As I pointed out before, their solution was chemical castration using a powerful anti-sex hormone drug called Lupron. They even called it their “Lupron protocol,” and a disturbing number of parents not only fell for this disturbing abuse of autistic children, but they even paid for it. Even after the revelations of what the Geiers did, I could never figure out, though, since 2006, more than three years ago, is just how. How did they manage to keep subjecting children to a treatment with science so bad that it doesn’t even qualify as junk science? (Testosterone sheets? Any chemist or endocrinologist would laugh at the idea.) And why didn’t the mainstream media ever notice, even though a small cadre of skeptical bloggers, of which I am proud to be part, blogged about it repeatedly?

I don’t know, but I do know that finally a major newspaper noticed. Yesterday, the Chicago Tribune ran companion stories entitled ‘Miracle drug’ called junk science and Physician team’s crusade shows cracks.

All I can say is that it’s about time.

I had first got wind through some of my online sources that the Tribune might be doing a story on the Geiers a couple of weeks ago. I was skeptical, but apparently the inciting event was the yearly autism quackfest known as Autism One held in Chicago every Memorial Day week. Mark and David Geier, as well as Dr. Mayer Eisenstein (whom we’ve met on this blog before and who apparently has fallen under the Geier spell and provides the Lupron protocol to the patients in his exceedingly woo-friendly HomeFirst practice, will be speaking there. For those not familiar with Autism One, it’s best described as an autism Quackapalooza. Chelation, anti-vaccine mania, hyperbaric oxygen, “biomedical” interventions, gluten-free diets, every form of autism woo and quackery that you can imagine is there, all under one roof, and every luminary of the antivaccine movement, including most of the crew of the antivaccine propaganda blog Age of Autism will be there, probably Tweeting and blogging away. Heck, Jenny McCarthy herself will be the keynote speaker in 2009, just as she was in 2008. (Don’t they get bored having the same keynote speaker year after year?)

Moreover, quackfest that Autism One is, the organizers don’t in the least like skeptics or those who don’t buy into the claim that vaccines cause autism to be there. They don’t like it at all. Indeed, one such skeptical blogger, despite remaining polite but firm in his questions, was expelled last year on a trumped up excuse. Indeed, the irony of the timing, so hot on the heels of Ben Stein’s evolution denying movie Expelled!, was not lost on us. This time around, they took measures to prevent any skeptics from infiltrating, but what are they going to do if the Trib decides to send reporters?

In any case, after all the woo that the Trib’s “health” reporter Julie Deardorff regularly lays down, I was very surprised at how good these two articles are. I truly wish they had been published in May 2006 rather than May 2009, but better late than never. Because I’ve already blogged about this before, I’m going to pick some things I learned that I hadn’t known before adn point out what is missing from this article that we in the blogosphere know about that is every bit as disturbing as subjecting autistic children to, in essence, chemical castration, behavior by the Geiers that strikes at the very heart of human research subject protections. If you need the gory details, go back and read my Part 1 and Kathleen Seidel‘s in-depth discussion of the Lupron protocol.

First, I like the chorus of strongly condemning quotes from real scientists studying autism:

Four of the world’s top pediatric endocrinologists told the Tribune that the Lupron protocol is baseless, supported only by junk science. More than two dozen prominent endocrinologists dismissed the treatment earlier this year in a paper published online by the journal Pediatrics.

Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.

“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,” he said.

Experts in childhood hormones warn that Lupron can disrupt normal development, interfering with natural puberty and potentially putting children’s heart and bones at risk. The treatment also means subjecting children to daily injections, including painful shots deep into muscle every other week.

And:

Specialists in autism, hormones and pharmacology who are familiar with the Geiers’ protocol said it cannot work as they suggest.

“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!”

I shared Dr. Baron-Cohen’s horror three years ago. So did Kathleen Seidel. So did a number of other bloggers. I didn’t really know, though, just how much money this protocol sucks out of desperate and gullible parents. Oh, I knew Lupron is an expensive drug and that insurance won’t pay for it for autism. That’s exactly why, as Kathleen put it, the Geiers found a way to label virtually every child they used the drug on as having “precocious puberty,” even though by definition any girl older than 8 or boy older than 9 cannot have precocious puberty. That doesn’t stop the Geiers from 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.

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.

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.

This is big bucks. Seriously big bucks. It’s also arguably insurance fraud, because the Geiers claim precocious puberty but in fact are using Lupron to treat autism. Moreover, the way they do their testing is absolutely guaranteed to produce in most children the “desired” diagnosis. The reason has to do, as I’ve described before, multiple lab values. The “normal” range of lab values, by definition, is designed so that 95% of “normal” patients will fall within that range. That means, for any “normal” child and any single given laboratory test, there is by random chance alone a 5% chance that his or her lab value will fall outside the “normal” range. 5% of 50 tests would mean that the average child would be likely to have 2.5 (or, given that these are whole numbers) between 2-3 lab values that fall outside the normal range. And–presto!–that will mean that they have “precocious puberty” and need the Geiers’ Lupron protocol. It’s all bogus (word choice intentional):

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?”

You know, I’ve been asking myself that question ever since I first learned about the Geiers and their “Lupron protocol.” I still can’t decide if they are true believers or if they are con men. it’s possible that they’re a little bit of both. What’s undeniable is that they are using a powerful sex hormone-suppressing drug on autistic children with no indication. Steve Novella was right to refer to it as an “atrocity.” Indeed, it’s so bad that the antivaccine propaganda blog actually–to my shock!–allowed a post that was critical of the Lupron protocol:

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.

Word to Mark and David Geier: When Age of Autism thinks you’re a quack, you’re in some serious, serious trouble from a credibility point. So what’s their defense? You guessed it! A panoply of the usual excuses used by purveyors of pseudoscience:

  • Don’t knock it till you’ve tried it: 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.
  • Misrepresenting the work of real scientists: 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.
  • Conspiracy theories: The Geiers also say mainstream medicine condemns them because of their vocal stance that pediatricians, health officials and drug companies are covering up the link between vaccines and autism. “Nobody likes a whistle-blower,” Mark Geier said in an interview.
  • The pharma gambit: The Geiers are not dissuaded by the criticism. Mark Geier said the courts are biased against him and that the medical establishment is more concerned about preserving drug companies’ profits than about protecting children. “There’s no question this will turn out to be true,” Mark Geier said in an interview, referring to the vaccine-autism connection.

And, most despicable of all, the Geiers demonize the very autistic teens upon whom they are plying their quackery:

“With masturbating there is a degree of normal, and then there is autism. Parents will say: ‘He will hump pillows, he will hump your leg,’ ” David Geier told doctors at Eisenstein’s office. He made similar statements on the same visit to about 60 parents of autistic children.

In an autistic teenager, high testosterone will lead to dangerous aggression, Mark Geier said, mentioning an autistic Ohio teen accused of killing his mother. “They are incredibly strong. They can hurt you,” he said. “You have to respect that these kids are on massive testosterone.”

Autistic children with high testosterone are heading down an ominous path, the Geiers said, and likely will end up hooked on psychiatric drugs, institutionalized or jailed.

I call bullshit, as does virtually anyone who knows anything about autism. Of course, the parents of Geiers’ patients are largely self-selected to believe the woo and have a serious incentive, after sinking thousands of dollars into it, to believe it’s working. And they do provide testomonials. Heck, it wouldn’t surprise me if some of them are even true. If you shut down a child or teen’s testosterone production, they will become more docile and have a decreased sex drive. That doesn’t mean the drug is doing anything at all for the teen’s autistic symptoms. Indeed, it could be doing great harm to the child. While Lupron may not be too risky for prepubertal children, giving it to teens can “put puberty on hold,” as one scientist put it, calling it “chemical castration”:

Said Kaplowitz: “You can lower sex drive, yes, but are you going to do that for every autistic [teenage] boy, do a medical castration? … For a year? For their lives?”

Neither Eisenstein nor the Geiers dispute that what they are doing amounts to chemical castration.

Speaking about one teen he put on the drug, Mark Geier said: “I wasn’t worried about whether he would have children when he is 25 years old. If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”

Karl Rove would be proud of Dr. Geier.

In a companion article, another aspect of the Lupron protocol is deconstructed:

Abbott Laboratories, which sells Lupron in the U.S., once applied for a patent with the Geiers through a now-defunct joint venture with another drug company, yet never pursued work with them. A spokeswoman for the North Chicago-based company said there was no scientific evidence to justify further research.

When a pharmaceutical company decides it isn’t interested in pursuing a potentially lucrative new indication for one of its drugs, you know you’re deep into pseudoscience. I will say, though, that Abbott Laboratories should be ashamed of itself. It’s winking and nodding at the use its product is being put to, even though it knows there is no scientific justification for it. Of course, the Geiers had already tried to patent their Lupron protocol once, because, of course, they’re doing this all out of the goodness of their hearts.

Not:

The Geiers’ first Lupron patient, a Virginia boy with severe autism who is now 13, started the treatment about four years ago. Since then, 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.

“We plan to open everywhere,” Mark Geier said in February at Eisenstein’s office. “I am going to treat as many as I can.”

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.

Again, I ask: How do the Geiers get away with it? These people are clearly practicing medicine without a license!

There were only two deficiencies in these articles. The first one almost goes without saying. There was too much of the “tell both sides” meme, in which testimonials were given far more weight than they deserved. I’ve given up expecting anything other than that from journalists. The other deficiency is that there was no mention of how the Geiers played fast and loose with human research protections in order to ply their quackery. The full length account is here; the CliffsNotes version follows.

Basically, the Geiers created an instituted, which they called the Institute for Chronic Illnesses, as a front under which to do their “studies” of Lupron. As part of that institute, they formed an Institutional Review Board (IRB) to oversee their “research.” They then stacked that IRB with cronies and true believers in violation of federal regulations. Indeed, they even went so far as having the principal investigator sit as the chair of the IRB overseeing his own research protocols. “Unethical” doesn’t even begin to describe this.

Criticisms aside, though, overall, I’m very happy that finally the mainstream media is noticing the Geiers’ pseudoscience and abuse of autistic children. Better late than never. Even better, today and article appeared about luminary of the antivaccine movement, Dr. Mayer Eisenstein.

Here’s hoping the Trib takes it a step further and covers the Autism One quackfest. If there’s one thing I’ve learned over the last four years, it’s that antivaccinationists do not like the harsh light of day shining down upon them. At least, they don’t like it if they can’t control the message, and in this case they’ve lost control of the message.