Monday, September 17, 2012

Mark Geier's License Revoked - And It's About Damn Time!

Today, Catherina over at Just the Vax, let me know about a development on a topic that I've been covering for quite some time. And the timing of this is rather fortuitous, as this post marks number 250 for me! I couldn't think of a better subject than to enlighten you all on the latest turn for the infamous Dr. Mark Geier, the physician who inappropriately used the precious puberty and chemical castration drug Lupron to supposedly treat children with autism.

What is this latest development? The Maryland Board of Physicians has (finally!) revoked Dr. Geier's medical license.
File this under: about damn time.
And the order that accompanies this is scathing.

Carole J. Catalfo, Executive Director of the Board, doesn't pull the punches in her rebuke of the disgraced physician. I'll get to some of the choice quotes a little later. First some background on the case.

Long, long ago (well, September of 2011) in a state just down the coast, a complaint was made and charges filed against Dr. Geier, citing several different violations of Maryland's Medical Practice Act, specifically:
(1) unprofessional conduct in the practice of medicine; (2) willfully making or filing a false report or record in the practice of medicine; (3) willfully failing to file or record any medical report as required by law; (4) practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine; (5) grossly overutilizing health care services; (6) failing to meet appropriate standards for the provision of quality medical care; and (7) failing to keep adequate medical records
Based on the nature (and, I'd wager, number) of violations, the board felt that there was an imminent risk of harm to patients and, in April 2011, suspended his license. This triggered a number of other states to suspend his licenses, as well. Dr. Geier appealed the board's decision, requesting that his case be heard before an Administrative Law Judge. His case came up in December 2011, taking five days overall. In March of this year, the judge found that Dr. Geier had, indeed, violated a number of provisions of the Medical Practice Act and entered a recommendation that his license be revoked. Dr. Geier and the board both filed exceptions and responses, which were heard before the board on May 23. Finally, on August 22, 2012, the board filed its final order revoking Dr. Geier's license.

The factual findings of the case should give even his most ardent supporters pause, and there are a number of them, the first of which was that he "failed to meet basic medical standards for evaluating patients and conducting medical examinations and keeping adequate records of treatments and diagnoses." He did not adequately examine patients before beginning treatment, and often did not have any data at all about patients' physical conditions. The order cites several examples of this (emphasis added):
For example, Dr. Geier treated Patient I for nine months without any physical examination and in fact without seeing him and without even documenting this patient's height and weight. He treated Patient B for almost three years without a physical examination and before ever seeing him, and he also treated Patient G without first physically examining him or ever seeing him in person.
I truly wonder how you can properly treat a child for supposed precocious puberty without either ever seeing the patient first nor monitoring progress to determine if the treatment is a) working and b) needed any longer!

The next finding was that Dr. Geier used Lupron in an unapproved manner. One must first actually find that a patient has precocious puberty before prescribing this powerful hormonal drug to treat it. Dr. Geier did not perform adequate testing in any of the children to make that diagnosis. As an example, a required part of testing is to perform a left wrist x-ray. He did not do this in a single case. Instead, according to the administrative filings, he relied mostly on information from parents, prescribing almost the same treatment for every child, regardless of what the parents described. He further failed to note an justification in their medical records for why he prescribed "an intensive regimen of therapy with powerful drugs".

Quite apart from using the drug off-label for an unapproved indication, Dr. Geier had come up with his own profile for when is was appropriate to prescribe Lupron. Yet only a single case (Patient E) met his dodgy profile, meaning that even if his idea of using Lupron to treat autism had any merit at all (snowballs in hell come to mind), he shouldn't have used it on any of the children except Patient E. And remember, even with Patient E, Lupron was not an appropriate drug to use, since this child was not properly diagnosed with precocious puberty.

As with Lupron, Dr. Geier also performed chelation without first properly finding a need to treat children with such a risky regimen, nor did he document in their medical records any justification for chelating them. The board found this to be a violation of the standard of care. They also found that he violated the standard of care by using the chelating drug DMPS, which is not approved for any indication in the United States.

Compounding his use of DMPS, he provided an informed consent form to the parent of Patient I which stated that a different FDA-approved chelating drug would be used as part of the chelation regimen. Not only did Dr. Geier use an experimental drug, but he lied about it to parents, essentially using their children as human guinea pigs. Oh, and the drug was to be inserted in the children's bums by the parents themselves.

After all of this, he failed to properly document the patients' progress in their medical records. Sure, he prescribed a laundry list of lab tests and gathered information from parents, but none of this was sufficient to properly manage the children's progress. For one, there was zero documentation that the tests he ordered had any bearing whatsoever on the treatment plan. He also ordered that one patient's (A) treatment be continued despite the fact that the child was leaving for Nigeria, thus putting him well out of range for any follow-up by Dr. Geier to monitor the patient. Nor did Dr. Geier provide a referral. Imagine, for a moment, that you are this child's parent. You make sure you have a decent supply of the treatment drugs to continue the protocol. How are you to gauge whether the treatment is working, how long you should actually keep doing it or even what you should do if (or when) your child's health declines as a result of these drugs? No one outside of Dr. Geier's offices knows anything about the protocol, considering it is not approved or recognized by any legitimate medical body for treating autism. To me, that is, to put it mildly, just a wee bit irresponsible.

Remember how I mentioned that he was essentially experimenting on children? Well, legally, if you are a physician and you are using a drug for an unapproved indication (and marketing this protocol), you are required to do so as part of a clinical trial. This involves coming up with the research protocol and having it approved by an Institutional Review Board (IRB), which, again by law, must be free of conflicts of interest in the proposed research. Dr. Geier told the parent of one child (Patient I) that the treatment was part of a protocol approved by an IRB. Technically, that's true. The big problem, though, was that the IRB was entirely made up of Dr. Geier and his friends and family. The IRB's role is to protect patients from harm (and not just physical) as a result of participating in a clinical trial. They are supposed to be independent and impartial. Tell me, how can an IRB be impartial about a protocol if the members (and indeed the Chair!) are intimately tied to the conduct and outcome of that trial?

Dr. Geier's deceit doesn't end there, however. He also falsified his credentials, claiming American Board of Medical Specialties certification when he didn't have any. He had claimed certification as a geneticist and as an epidemiologist. The ABMS did not certify him in either of these fields.

So, here we have a deceitful individual conducting what amounts to unapproved experimentation on children. You would think that maybe, just maybe, he would do some manner of gauging whether or not his treatment was actually working, right? I know if I or my child were part of human research, I'd want to make sure that the researchers were actually gathering data that would be sufficient to figure out whether or not the experimental protocol was actually working and that it was safe. Responsible researchers do just this. They gather not only enough information, but also the right data to determine whether their treatment was working or when it should be changed or stopped. Not so, Dr. Geier! From the board's order:
Despite the accumulation of thousands of laboratory tests, there is not enough information in the charts for anyone to make any rational medical evaluation of the progress of the patients, to make any rational medical decision to change treatment, or to make any rational decision to change the diagnosis. Nevertheless, without sufficient information, Dr. Geier variously continued the treatment, changed the treatment, and even changed the diagnosis.
I truly feel for the patients preyed upon by Dr. Geier. He callously exploited them, and even had the gall to defend his actions with ridiculous assertions:
Dr. Geier argues that the ALJ should not have faulted him for prescribing Lupron and chelation to patients who did not fit his profile...The profile, however, is Dr. Geier's only justification for this off-label treatment...Dr. Geier nevertheless argues that a "trained clinician" can "identify the correct therapy after an appropriate examination."
This, in my opinion, is golden:
Dr. Geier, however, is not a "trained clinician." He completed only a one-year residency in obstetrics and gynecology, has no formal specialized training in the treatment of autism, and is not Board certified in any medical specialty. Nor did he complete an "appropriate examination" of these patients.
Ooh...that's gotta hurt. And in response to Dr. Geier's defense of his medical records as being adequate, Catalfo writes:
Medical records that are decipherable only to a small group of physicians, physicians who practice the same type of unconventional therapy on a full-time basis, are not "adequate" medical records, in the Board's view.
Finally, the Sanction section of the order is worth quoting in full (emphasis added):
The ALJ commented that Dr. Geier abused the trust that these patients' families placed in him. "By dissembling, misrepresenting, failing to see his patients for months and years before treating them, applying a protocol-based treatment to children who do not fit the protocol, using non-FDA-approved drugs without fully informed consent, and for all of the other violations found and discussed in this Proposed Decision, he abused that trust. I agree with the State that these actions betray the relationship of a physician to a vulnerable child and his desperate parents." The Board agrees.
The ALJ proposed that the Board revoke Dr. Geier's license. Dr. Geier has displayed in this case an almost total disregard of basic medical and ethical standards by treating patients without properly examining or diagnosing them, continuing treatment without properly evaluating its effectiveness, and providing "informed consent" forms that were misleading and in at least one case blatantly false. He provided treatments supposedly according to an investigational protocol, but the investigation was approved only by a sham Institutional Review Board, and he applied protocols to patients who did not fit his own profile. He provided treatment by a drug not approved for use in this country while informing parents that a different drug would be used. His actions toward his patients were not those of an honest and competent physician, nor do they appear to be those of an objective and ethical researcher. Dr. Geier made little use of those methodologies that distinguish the practice of medicine as a profession. At the same time, he profited greatly from the minimal efforts he made for these patients. In plain words, Dr. Geier exploited these patients under the guise of providing competent medical treatment. Such a use of a medical license is anathema to the Board. The Board has no hesitation in revoking his medical license.
While it is relieving that his license in Maryland has finally been revoked, it pains me how long it took them to do this. I'm just glad to know that he can no longer prey upon desperate families and their children in this way. His license had already been suspended in nearly every other state in which he is licensed, and even revoked already in Indiana (as well as a petition to revoke filed in California), but I anticipate all of these states to revoke his license, now that he has lost his case in Maryland.

But I don't think that things will end there. With the revocations, I foresee a number of fines and other possible penalties. For one, there is still the case against his son, David, for practicing without a license. [ETA: Just recalled that I mentioned the case against David Geier last month. He was found to have practiced without a license and was fined $10,000. I speculated at the time that there could be further criminal proceedings against him as well.]If it is found that he aided his son, Dr. Geier will face some manner of penalty for that. There's also still the matter of Dr. Geier violating his suspension by prescribing medications; that constitutes practicing medicine without a license and, as with his son, includes both civil and criminal penalties.

The long and the short of it is this: although the legal proceedings against Dr. Geier may not be finished, his medical career is effectively over.
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1 comment:

  1. Great illustration of what each point in the Board decision actually means - linked back from JTV now.


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