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Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

20 May

The father-son team of Mark and David Geier have been charged with violations of medical practice. Mark Geier is a physician and his son, David, holds a bachelor of arts degree. Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine is the most recent post by Kathleen Seidel of Neurodiversity.com. This follows the suspension of Dr. Mark Geier (Maryland Medical Board Suspends Dr. Mark Geier’s License).

Ms. Seidel’s post follows her practice of a very thorough, well linked discussion of the topic. Here is her first paragraph (without links):

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

It is well worth the time to read the entire post: Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

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.

Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

4 May

Dr. Mark Geier is well known in the world of alternative medicine and autism. He, together with his son David, work a medical practice and publish papers. They are long-standing proponents of the vaccine-causation hypothesis, presenting pseudo-epidemiological studies as support. Dr. Geier has worked as a witness in the vaccine court, has has a long history of criticism for his work there.

One of the stranger notions Dr. Geier has put forth involves testosterone. In their model of autism, testosterone binds with mercury in the brain and makes it difficult to remove through chelation. For many, many reasons, this was just plain wrong. Based on their mistaken hypothesis, the Geiers have promoted a treatment for autism based on reducing testosterone in autistic children. In short, they put children on an injected drug: Lupron.

This idea has met with much criticism. Probably no one has studied the Geier’s and their actions more closely than Kathleen Seidel on her blog at Neurodiversity.com. Five years ago and more she exposed the “Lupron Protocol” in a sixteen partseries called

Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol.

Well, it isn’t just one of the best bloggers saying it anymore. The Maryland Board of Physicians has investigated Dr. Geier and Dr. Geier has now had his license suspended.

Here is part of the Order for Summary Suspension:

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial risk of both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The introduction goes on.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and expensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard of quality care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlying medical condition.
The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.
There are no evidence-based studies to support either the Respondent’s Lupron Protocol or his administration of chelation therapy to autistic children; he relies in large part on his own studies which have been wholly discredited by the Institute of Medicine and denounced by the American Academy of Pediatrics. The Respondent’s treatment of autistic children with his Lupron Protocol and chelation therapy is not limited to Maryland. Indeed, in a recent article in the Chicago Tribune, the Respondent stated his intent to open clinics all over the United States, H[w]e plan to open everywhere. I am going to treat as many as I can.

The introduction ends with this paragraph:

The Respondent endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.

Pretty much sums it up. There are numerous counts and details listed in the full document. Below I’ll highlight some specific statements.

Patient A, a child whose mother stated aggression was not a problem, was reported as having aggression and self-injurious behaviors:

Notwithstanding Patient A’s mother’s report that aggression was not a problem with Patient A, the Respondent noted in the “Precious (sic) Puberty Evaluation” section of the form that Patient A, “bites and punches others; hits head with hands.”

As with many (if not all of the children) listed in the order, the diagnosis of precocious puberty was not considered valid:

45. The Respondent misdiagnosed Patient A with premature puberty. Significantly, Patient A did not meet the age criteria for premature puberty.
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.

One question that is often raised with alternative medical practitioners is the validity of their diagnoses. Quite often this involves diagnoses of “heavy metal toxicity” using non-standard tests. In the case of the Geier’s, there is also the validity of diagnoses of “precocious puberty”. There are standards for age, and for tests which should be performed. Reading the order, it is clear that age requirements were often ignored. Bone density tests were often not performed:

The Respondent failed to assess Patient B’s bone age, assess the child’s growth velocity or order a GnRH test to confirm the presumptive diagnosis of precocious puberty.

Also, the signs of precocious puberty could be due to a brain tumor. Yet brain scans were not performed. This from Patient E:

In addition, the Respondent failed to assess Patient E’s skeletal maturation by ordering an x-ray of her left wrist and he failed to order a scan of her brain in order to rule out a tumor.

Another question that often comes up with the Geier practice is what role David Geier plays. David Geier holds only a bachelor’s degree. He is not a physician. Patient C appears to have been examined by David Geier, with Dr. Mark Geier absent:

Patient C’s mother returned to the Respondent’s office on May 19, 2008 because of the worsening of Patient C’s aggressive behaviors. According to her complaint, the Respondent was not present during this office visit, She saw only his unlicensed son.

And, yet, the child was given “comprehensive” abdominal and thyroid ultrasounds at the visit:

The note of the visit indicates that “comprehensive” abdominal and thyroid ultrasounds were performed. Patient C’s physical appearance is described as suggesting “advancement from his chronological age” and that he appeared to be “potentially significantly physically aggressive to himself and/or others.”

and something akin to a diagnosis was rendered:

A portion of the “Psychological Examination” section of the note states, “It is apparent based upon examination of the DSM-IV criteria that [Patient Crs present symptoms are compatible with a diagnosis of pervasive developmental delay – not otherwise specific (sic).”

One problem with research performed by the Geier’s is the lack of an appropriate IRB–institutional review board. Dr. Geier placed himself, his wife and his son on the IRB. Not noted in the Order is the timing of the IRB. If memory serves correctly, there is evidence that the IRB was put into place after research began.

An IRB must consist of at least five (5) members. The ICI IRB’s members include the Respondent, his son and the Respondent’s wife. The ICI IRB is inconsistent with the requirement that a member should not have a conflict of interest in the research project.

The Order includes discussion that “The Respondent [Mark Geier] Misrepresented His Credentials”. When the investigative board interviewed him, here is how Dr. Geier described himself:

On November 6, 2007, in furtherance of the Board’s investigation, Board staff interviewed the Respondent. During the interview, the Respondent stated that he was a board-certified geneticist and a board-certified epidemiologist. The Respondent stated that he had been board-certified in epidemiology in 2007.

However, “board certified” and “geneticist” seem to be incorrect:

As to being a board-certified epidemiologist, this appears to be inaccurate:

166. By letter dated March 29, 2011, the Respondent, through counsel, submitted to the Board a “Fellowship Certificate” from the American College of Epidemiology (“ACE”). The ACE is a professional association whose policy on admission is “inclusiveness.” An ACE fellow is not required to have a degree in epidemiology, a degree in a “related field” is sufficient.
167. The Respondent knew, or reasonably should have known, that he was not board-certified in epidemiology.

As to being a “geneticist”, Dr. Geier is a “genetic counselor”, a different creature:

168. By letter dated March 29, 2011, the Respondent, through counsel, also submitted to the Board a certificate issued by the American Board of Medical Genetics on September 15, 1987 certifying the Respondent as a Genetic Counselor.
169. The term “genetic counselor” is not synonymous with “geneticist.” A geneticist, or medical geneticist, is a physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests. A genetic counselor is an individual with a masters degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.
170. The Respondent knew, or reasonably should have known, that he was not a board-certified geneticist.

Geneticist/genetic counselor and whether he is board certified in epidemiology or not are interesting but minor questions compared to the board findings of misconduct in treating disabled children. So it comes as no surprise that it is ordered:

Based on the foregoing, it is this 27th day of April , 2011, by a majority of the quorum of the Board:
ORDERED that pursuant to the authority vested by Md. State Gov’t Code Ann., § 1 0-226( c)(2), the Respondent’s license to practice medicine in the State of Maryland be and is hereby SUMMARILY SUSPENDED;

Mr. Mark Geier is at present unable to practice medicine in his home state of Maryland.

kathleen Seidel has already blogged this: Maryland Medical Board Suspends Dr. Mark Geier’s License

Sloppy science – a perfect example of how the anti-vaccine crowd will listen to anything

11 Feb

Both Age of Autism and David Kirby have recently reported on a new review paper with Age of Autism describing it as ‘pretty interesting’ and David repeating a part of the abstract:

Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis following vaccination.

So, should we all in the skeptic camp be reaching for our humble pie and our knife and fork? Not exactly. Lets take a look at the contents of this paper. Lets start here:

The vaccine organism itself could be a culprit. For example, one hypothesis of the cause of autism is that the pertussis toxin in the DPT vaccine causes a separation of the G-alpha protein from retinoid receptors in genetically at-risk children (Farfel et al., 1999; Megson, 2000). The pertussis toxin creates a chronic autoimmune monocytic infiltration of the gut mucosa lamina propia and may disconnect the G-alpha protein pathways, leaving some G-alphamodulated pathways unopposed. In turn, the non-specific branch of the immune system is turned on and, without retinoid switching, cannot be down regulated.

Wow, blinded with the cool science yet? No, me neither. Go back to line one where it says ‘one hypothesis’. All that follows from that point is mere opinion. There’s no science to back it up.

Another organism of suspect is the live measles virus…

Yeah except its really not. The issues with the Wakefield hypothesis are so many and so thoroughly debunked, it really isn;t worth my time or yours going through them again and again.

There is evidence that Thimerosal (which is 49% ethyl mercury) is indeed harmful. Since the 1930s, Thimerosal has been extensively used as an antibacterial agent in vaccines (Geier et al., 2007). Thimerosal has been implicated as a cause of autism. Not only is every major symptom of autism documented in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of mercury poisoning itself (Bernard et al., 2001)

Oh dear. Reliance on more thoroughly debunked rubbish in the form of well, anything by the Geier’s and the ridiculous Bernard ‘paper’. I’m happy to go through why these are rubbish but I think I’d be preaching to the converted.

The rest of the paper is a rogues gallery of debunked and fringe science. Helen Ratajczak cites the Geier’s numerous times, DeSoto and Hitlan, Nataf and Rossignol to name but a few. This isn’t a paper so much as an advert for the sort of poor science that was examined in the Autism Omnibus proceedings and roundly rejected by the Special Masters. For goodness sake, she even cites David Ayoub of the Black Helicopter infamy.

When it comes to this paper – handle with extreme caution. Its toxic rubbish.

Crist backer Gary Kompothecras bullies Florida health officials

28 Sep

Crist backer Gary Kompothecras bullies Florida health officials, a story in the Miami New Times, discusses how a wealthy man is attempting to exert influence to get Dr. Mark and Mr. David Geier access to Florida Department of Health records.

Here are the first three paragraphs:

“This madness has got to stop. No more double talk. This should be a fairly straightforward study. I feel that there are hidden agendas going on and I will not stand by [and] let it continue!! I will not wait any longer,” reads an email dated August 6 from Dr. Gary Kompothecras to Dr. Julia Gill, director of the Florida Department of Health’s (DOH) Division of Disease Control.

Coming from anyone else, the blustery email threat might be easily dismissed. But “Dr. Gary,” as Kompothecras is known, is the self-styled “Rainmaker,” a Sarasota chiropractor who has raised more than $1 million over the years for Senate candidate and soon-to-be ex-governor Charlie Crist.

So it’s bound to turn heads when the man known to occasionally lend his private jet to the governor uses his political clout to try to bully Florida health officials into turning over scores of the state’s sealed immunization records. Especially when they’re for a father-son team, Dr. Mark and David Geier, infamous for injecting autistic children with Lupron, a drug used to chemically castrate prostate cancer patients and pedophiles.

Dr. David Gorski, who blogs at Science Based Medicine, was quoted:

According to Dr. David Gorski, founding fellow of the Institute for Science in Medicine and an NIH-funded cancer researcher, the Geiers’ Lupron treatment is “in essence, chemical castration in order to treat autism based on no reliable science.” Says Gorski: “The concept that [the Geiers] embraced isn’t even bad science. It’s just not science.”

As I commented on the webpage for the story, when it comes to thimerosal in vaccines and autism, the recent study in Pediatrics far surpasses anything the Geiers could accomplish with the data from Florida.

If the information I have is accurate, Mr. Kompothecras filed in the Court of Federal Claims (vaccine court) for two children. One case has been closed and the other is still pending. (correction–there appear to have been three cases opened. One has been closed)

Another example of the workings of the vaccine court

4 Aug

This doesn’t involve the autism cases. Instead it is about the Hepatitis B omnibus proceeding which is also ongoing. It does involve some familiar names: Clifford Shoemaker (attorney), Dr. Mark Geier and his son David Geier. It does give us some insight into the billing practices of these gentlemen.

As background I’ll note that Clifford Shoemaker subpoenaed blogger Kathleen Seidel of Neurodiversity.com. He ended up being sanctioned for that action.

Dr. Mark Geier has been a frequent consultant to Mr. Shoemaker’s cases in the vaccine court. Ms. Seidel has covered some of the cases before where Dr. Geier has participated.

David Geier has so far not been compensated as a consultant to the Court.

In a recent case, Quinton O. Riggins, Jr. v. Secretary of HHS, we can see some of the decision processes involved in awarding fees to attorneys and consultants in the Court.

The application was for a total of $221,211.34:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

Of this, about $96k was paid:

Accordingly, petitioner is entitled to the following award for fees and costs for efforts in the Riggins case and for efforts on the hepatitis B cases in general: $95,801.72 for attorney’s fees and costs to be paid by check payable to petitioner and petitioner’s counsel; and $528.25 in petitioner’s costs to be paid by check payable to petitioner. The Clerk shall enter judgment accordingly.

The analysis of the application is lengthy. I will quote some sections below.

In regards to Mark and David Geier:

“Petitioner’s counsel requests $110,386.73 in costs related to S&A’s general hepatitis B work, of which counsel has earmarked $97,443.43 as costs (for fees and expenses) owed to Dr. Mark Geier and his son, David Geier.”

In the end, Dr. Mark Geier was paid $10,000 and David Geier was not compensated.

In denying payment to David Geier, who holds a bachelors degree, the Special Master noted:

“In summary, the undersigned finds the costs for David Geier’s efforts to be obviously unreasonable as Mr. Geier is not qualified to address the medical issues involved in the Program and his work was duplicative of the efforts by Dr. Geier. Thus, the undersigned denies the request for costs for David Geier in its entirety.”

In regards to Dr. Mark Geier:

However, Dr. Geier’s qualifications as an expert, testimony in the Program, and credentials, have been subject of considerable criticism over the years by the court. The undersigned questioned his expertise as far back as 1991. Daly v.Sec’y of HHS, No. 90-590V, 1991 WL 154573, at *7 (Cl. Ct. Spec. Mstr. July 26, 1991) (“[T]his court is inclined to not allow Dr. Geier to testify before it on issues of Table injuries. Dr. Geier clearly lacks the expertise to evaluate the symptomatology of the Table injuries and render an opinion thereon.”). More recently, in a published Order, my colleague, Special Master Vowell, addressed this criticism, as well as her concerns regarding petitioners utilizing medical articles authored by Dr. Geier, as follows:

I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters and several other judges have opined unfavorably on his qualifications and testimony as an expert.

It appears that since the Court has found that Dr. Geier is not qualified as an “expert”, he was retained as a “consultant”. However, he appears to have acted in ways overstepping the bounds of “counsultant”.

In the instant matter, the undersigned finds it was reasonable (and appropriate) for counsel to consult with Dr. Geier in a limited manner regarding the hepatitis B claims. Those efforts would entail Dr. Geier performing an initial review of the counsel’s hepatitis B claims and some initial research regarding vaccine injuries resulting from hepatitis B vaccine. Dr. Geier would then educate counsel as to the nature of the issues and the types of experts required. However, once Dr. Geier performed an initial review of these claims for counsel, and once counsel began reaching out to doctors who would ultimately serve as experts in S&A’s hepatitis B claims, it was no longer reasonable for Dr. Geier to be billing hours and incurring costs in S&A’s general hepatitis B efforts. Dr. Geier at this point was moving well beyond the role of a consultant.14 Thus by the beginning of 2002, when Mr. Shoemaker began to meet with experts15 to assist in the prosecution of the hepatitis B claims, Dr. Geier’s work on behalf of S&A’s general hepatitis B efforts was no longer needed and should have concluded.

Because of this, Dr. Geier was compensated at a reasonable amount for his consulting activities.

The undersigned notes an award of $10,000.00 represents an almost 90% reduction of the invoice submitted by the Geiers in this matter. The award of $10,000.00 is reasonable for Dr. Geier’s consultant efforts, and thus should not be viewed as a “reduction,” but viewed as reasonable compensation for Dr. Geier’s role as a consultant. The time not compensated is time largely spent by Dr. Geier duplicating the efforts of the experts, duplicating his own work, or performing work as an expert (work he is not qualified to perform). Stated another way, once experts were identified and became involved, Dr. Geier’s role as a consultant ended.

Mr. Shoemaker requested $221,211.34 in fees and costs:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

The court found that $64,254.45 was reasonable.

Here is an example of a charge that was denied:

The 5/30/2006 entry bills 0.5 hours to “[r]eview excel chart and update information; transfer information needed for SC to laptop,” P. App at 18. The “transfer information needed for SC to laptop” entry was explained by counsel asconstituting mere seconds and thus not administrative overhead. P Resp at 2, fn 1. However, counsel failed to address the remainder of the entry and identify what excel chart he was updating and how that activity was relevant to Mr. Riggins’ case. However, far more egregiously, counsel has billed for this exact same activity on precisely the same date twice before in two separate hepatitis B cases.

Trips to France and Italy were also excluded:

Another extreme example of counsel’s error in billing judgment is the request by counsel for fees and costs billed by Dr. Mark Geier and David Geier for trips to France and Italy in the summer of 2005 and winter of 2006 respectively, and for Mr. Shoemaker to travel to France with the Geiers in the summer of 2005. These requests represent a complete abdication of billing judgment.

Dr. Geier and Mr. Geier together billed a total of over $20,000.00, P App at 62-63, to travel along with Mr. Shoemaker to France and meet with various doctors and lawyers to discuss adverse events following the hepatitis B vaccination. Dr. Geier, in his affidavit, and counsel in Petitioner’s Sur-Reply, allege it was necessary to travel to France to discuss the doctors’ and lawyers’ experiences and research relating to adverse reactions stemming from the hepatitis B vaccination, and that this information could only be obtained in “face-to-face” discussions. In addition, Dr. Geier and Mr. Geier together billed $23,690.00 to travel to Italy to attend the 5th International Conference of Autoimmunity. Petitioner argues in Petitioner’s Response that the Geiers were invited to present their research at the conference by Dr. Shoenfeld, a leading expert in autoimmunity, and that at the conference they were able to secure Dr. Shoenfeld’s services as an expert in counsel’s cases. Petitioner further alleges the Geiers were able to discuss autoimmune disorders with experts at the conference and further “expedite the prosecution of various hepatitis b cases.” P Resp at 12.

and

Additionally, the Geiers provided absolutely no supporting documentation, such as receipts, to evidence the $9,399.68, see P App at 60, they allege they incurred in costs for airline tickets, other transportation costs, parking, hotel, “daily expenses,” food, and conference fees during these trips. P App at 61-62. By itself, this failure justifies not awarding these costs.

Many expenses for Mr. Shoemaker were questioned by the Special Master. Some based on the lack of adequate justification for the costs:

Petitioner’s counsel has failed to provide adequate information for the undersigned to determined exactly what the costs represent and whether or not the costs were reasonably incurred. No receipts are provided for any of these expenses. For example, for what did counsel pay costs to Federal Express? Who traveled to Boston and stayed at the Ritz Carlton? What expert was met with in Boston? Who traveled to Florida? And what attorney was met with in Florida?

Other expenses were considered to be “overhead”

Respondent objects to five hours of time billed by counsel for “‘meeting with consultants about scanning issues’” on April 19, 2000; one hour of time billed by counsel for “‘review[ing] computer breakdowns and update computer field’” on October 8, 2002; and three hours of time billed by counsel for a “consultation with Legal Nurses Association to discuss reviewing cases and preparing chronologies” on September 19 and 21, 2001. R Opp at 17; see also R Reply at 7. Respondent objects to these billings on the basis that the billings are administrative in nature, “more properly categorized as overhead” and would benefit “all petitioners represented by [counsel’s] firm.” Id. The undersigned agrees.

The entire decision is 37 pages long, detailing the requests for reimbursments, fees and costs.

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?

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