Do we have to wait for someone to be injured to call a practice unsafe?

5 May

Mark Geier has had his license to practice medicine suspended in his home state of Maryland. The Chicago Tribune (which has discussed Mark Geier and his “lupron protocol”) has a story discussing this: Trib Update: Md. suspends autism doctor’s license.

These paragraphs stood out when I read them:

In some cases, the board found that Geier diagnosed the children with precocious puberty and prescribed Lupron and other hormone-disrupting drugs without examining them or conducting proper tests. Some of these children were within the normal age range for puberty, so they couldn’t have qualified for such a diagnosis, the board found.

Geier, who is not allowed to practice in Maryland while the case is pending, declined comment, instead referring questions to an attorney. The attorney, Joseph A. Schwartz III, said that at the root of the complaint was a “bona fide dispute over therapy” rather than a case of a doctor who is an immediate threat to patients.

“If you read the (complaint), you say, ‘Holy God, this is awful.’ But if it were so awful they should have an injured child, and they don’t. I would hope that the board would step back and say, ‘Maybe there’s a lot of controversy and he’s not in the mainstream.’ But let’s test these allegations in a fair hearing. It’s just like shadow-boxing with allegations that sound awful but when you delve into the facts of them you say, ‘What’s the big deal here?’” Schwartz said.

“But if it were so awful they should have an injured child”

Do we really have to wait for someone to be injured? Clearly, the answer is no. “An immediate threat” is different from “has already caused harm”.

Let’s address this question: “What’s the big deal here?” Let’s address it in short, easily digested statements, centering around the fact that this is a breach of ethics, not a question of treatment modalities.

Here are a few “big deals” which come to mind readily:

1) diagnosing children with a condition they do not have (precocious puberty)
2) not performing the follow through to see if children have brain tumors, which would be possible if the diagnosis were real.
3) doing (1) to justify a very serious medication for the disabled children
4) allowing an untrained/unlicensed person to perform examinations

Mr. Geier is very lucky that no one was injured. His original methodology included giving

Here is the paragraph on “use” for Lupron:

LUPRON DEPOT?PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg and 15 mg are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

One issue that came up was Mr. Geier’s lack of followup testing. Having diagnosed precocious puberty, he should have ordered tests to rule out brain tumors. These were not performed. This makes one question: did he actually believe the diagnoses himself or was he just negligent in calling for the brain scans?

Something caught my eye that I hadn’t seen before. Notice the pediatric dosage: 7.5, 11.25 and 15 mg. This is the same dosage that the Geiers note in their patent application: US20070254314A1: Methods of treating autism and autism spectrum disorders.

Check the dosages given to some children:

On Nov. 24, 2004, Child X was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

On Apr. 2, 2005, Child Y was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

Perhaps the pediatric doses were larger back then. I’d be very interested to know, as these children were given dosages above the maximum listed values.

In an interesting side note in this story. Mark Geier’s son, David, was appointed to a position on the Maryland state’s autism commission as a “diagnostician”. Apparently his position is being reviewed and he has been asked to resign:

Gov. Martin O’Malley appointed David Geier in 2009 to the state’s Commission on Autism as a “diagnostician,” a decision state officials are now reviewing. David Paulson, a spokesman for the state health department, said David Geier declined Wednesday to resign from the position.

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10 Responses to “Do we have to wait for someone to be injured to call a practice unsafe?”

  1. Calling Peds Endo STAT May 5, 2011 at 12:19 #

    Re: the dosing. The Depot shot is a monthly shot determined by lab work, if memory serves, in terms of standard Peds Endo usage. It’s used this way in pediatric endocrinology — the monthly injection. Some Peds Endo pts will also, say, be under growth hormone therapy simultaneously. The Geier team, however, not only delivered the monthly depot shot, but also (as I’ve read thru the years from Ms Seidel & Trine) prescribed additional daily doses. I think this could be where the conflicting/dispirate dosing amts are coming from. From my understanding, the Geier protocol consisted of the monthly lupron depot injection & then various injections per day (or more or less). This is completely outside the range of any Peds Endo protocol & all these kids should be seen by highly qualified Endocrinologists … this really goes without saying. [Also, an aside: what they’re looking for is a ‘pituitary’ tumor (as is my understanding) which affects growth]. Lastly – excuse typos from my handheld – thx.

  2. Prometheus May 5, 2011 at 17:26 #

    I strongly suspect that the reason Dr. Geier didn’t do the appropriate testing for precocious puberty (e.g. wrist X-rays, hormone levels, brain MRI) was that he didn’t really think these children had precocious puberty. That diagnosis was simply a way to get the insurance companies to pay for the Lupron.

    Geier is on record as believing that the real purpose of the Lupron is to reduce testosterone levels because – in his “alternate” universe – testosterone binds to the mercury from vaccines and prevents it from being excreted (while somehow not preventing it from causing damage). This is his infamous “sheets of testosterone” hypothesis which he based on a decades-old article about crystallising testosterone with mercury at high concentrations in hot benzene.

    Anybody who thinks that this model even vaguely approximates what happens in the human body needs further education in physiology.

    So, the appropriate work-up for precocious puberty wasn’t done because Dr. Geier wasn’t treating precocious puberty – he was treating sheets of testosterone complexed with mercury (which, as I pointed out, can’t exist in a living person). This is probably also the reason he didn’t need to perform an examination, as that wouldn’t add anything to his pre-formed diagnosis.

    Is it insurance fraud or is it delusional thinking? Or both?

    Prometheus

    • Sullivan May 5, 2011 at 18:33 #

      “So, the appropriate work-up for precocious puberty wasn’t done because Dr. Geier wasn’t treating precocious puberty – he was treating sheets of testosterone complexed with mercury (which, as I pointed out, can’t exist in a living person).”

      I think we are on the same page on this: the idea that testosterone/mercury complexes exist within the human body is so poorly argued as to be laughable. (OK, you didn’t say laughable).

      Assume you believed this idea. One then has to ask whether Lupron would do anything. I doubt it would. Lupron does not remove testosterone. It isn’t a testosterone “chelator”, if you will. There is no reason to suspect that treating a child with lupron would break apart these mythical mercury/testosterone complexes.

  3. David N. Brown May 5, 2011 at 19:24 #

    @Prometheus,
    I think the more fundamental issue/subtext has been trying to stop inappropriate behavior, which the Geiers have referred to openly and rather graphically, and may sincerely equate with autism and/or mercury poisoning. As a means of behavioral control, lupron therapy would actually make sense, though it would be as drastic and arguably disproportionate as punishing theft by cutting off a hand.

  4. stanley seigler May 5, 2011 at 20:35 #

    [LBRB say] “But if it were so awful they should have an injured child”…Do we really have to wait for someone to be injured? Clearly, the answer is no. “An immediate threat” is different from “has already caused harm”.

    tho we shouldn’t…we do! even when there are injured…we do nothing…well we do initiate useless, conscience salve, commissions…

    abuse abounds…p-poor support exceeds abounding abuse…and increases abuse…sick, sick, society.

    not sure i understand diff between “immediate threat” and “already caused harm”…past immediate threats have/do caused/cause harm…ie, past now the present immediate threat.

    stanley seigler

  5. Calling Peds Endo STAT May 5, 2011 at 20:44 #

    Agree all around. So, in line with what David said I think the dosing amt. may have been determined behaviorally/appearance-wise vs. any labs (even biomed ones). Hence, the monthly depot injection along with the daily shot (which I could swear i recall reading was sometimes twice daily) in varying dosages. BTW, from my talks with several Ped Endos this med works differently in a child’s body vs an adult’s — ie whether one has entered or gone thru puberty or not. That’s also speaking in terms of its medically proven intents….

  6. Interverbal May 6, 2011 at 05:39 #

    Read:

    “The attorney, Joseph A. Schwartz III, said that at the root of the complaint was a “bona fide dispute over therapy” rather than a case of a doctor who is an immediate threat to patients.”

    Then read from the suspension order:

    “46. In addition, the results of Patient A’s laboratory studies do not support the Respondent’s diagnosis. The Respondent reported that Patient A’s testosterone metabolites were “significantly increased;” however, the results of Patient A’s luteinizing hormone (“LH”) were only marginally elevated, and his free testosterone and DHEA were within range for a ten (10) year old male.”

    And finally read:

    “What’s the big deal here?”

    Words evade me.

  7. Anne May 7, 2011 at 08:01 #

    Clarification on “immediate threat” vs. “already caused harm”:

    If I’m in a subway station swinging a fire axe, I’m an immediate threat even though I may not have hit someone *yet*. Sooner or later, I’m going to hit someone even if I’m not aiming for them.

  8. brian May 19, 2011 at 23:12 #

    Geier’s son was just charged with practicing medicine without a license:

    http://www.baltimoresun.com/health/bs-hs-david-geier-charged-20110519,0,3290629.story

    [The mother of a c hild with autism]complained to the board in 2008 that David Geier had diagnosed her then-10-year-old son, used an ultrasound wand on him as he walked around the room and ordered so many tests that the lab questioned how much blood they would have to draw. The mother, who was not identified in board’s report, also said she assumed David Geier was a physician.”

    In its new report, dated May 16, the board said that David Geier had also practiced medicine on a host of other patients.

    • Sullivan May 20, 2011 at 00:06 #

      Dang Brian, you are fast

      I’m linking to Kathleen Seidel’s piece tomorrow.

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