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Defending alternative medicine and autism: the charges against Anju Usman

14 Oct

In Illinois charges DAN doctor with unethical behavior, LBRB writer Ken Reibel discussed the case recently brought against alternative medical practitioner Dr. Anju Usman. These charges follow on a civil suit brought by the parent of an autistic child seen by Dr. Usman. This charges in this case will require that Dr. Usman defend many of the common practices in alternative medicine.

The complaint is:

DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION of the State of Illinois,

v.

ANJUM I. USMAN, M.D.

No. 200904994

One short paragraph in the complaint sums up a big piece of where this suit has the possibility to strongly influence how alternative medicine “treats” autism: None of the treatments described above has been proven to influence the course of autism.

Here is a section of count 1:

17. Hair analysis does not provide a basis for the diagnosis of heavy metal toxicity.
18. Provoked urine testing does not provide a basis for the diagnosis of heavy metal toxicity. The American College of Medical Toxicology has determined that provoked testing has not be scientifically validated, has no demonstrated benefit and may be harmful when used for assessing patients for metal poisoning.
19. Porphyrin testing does not provide a reliable basis for the diagnosis of heavy metal toxicity.
20. Although chelation therapy is FDA-approved for treating lead poisoning, it should not be used unless a non-provoked blood (not urine) test shows an extremely high level of lead.
21. Respondent did not obtain a confirmatory blood lead test or record any source of lead exposure.
22. The record contains no basis for concluding that chelation therapy was appropriate.
23. The record does not contain adequate infonlled consent for any of the prescribed nonstandard tests or treatments. The consent fonns used did not accurately present the risks and/or benefits of tests and treatments. Although it mentioned experimental drug use, these were not administered as part of a proper experimental protocol.
24. The informed consent form states that chelation therapy “is considered controversial for the generalized treatment of chronic low or high level lead toxicity, mercury toxicity, or for other heavy metal toxicities, either acute or chronic.” This statement is misleading because there is a clear scientific consensus that it is inappropriate for treating lead toxicity without demonstrating that toxicity exists and that the level is very high.
25. Throughout the treatment period, Respondent made statements to AC’s mother that the prescribed treatments had positive clinical benefits for children with autism, despite the lack of empirical research supporting Respondent’s position.
26. The record does not document any reason why AC should have received unproven treatments.
27. Spironolactone, which is potentially dangerous, was prescribed without justification.
28. Despite a nonnal selenium level, Respondent repeatedly and unnecessarily prescribed selenium supplements and continued to do so even when AC eventually showed a high level.
29. That Respondent abused the physician/patient relationship by taking unfair advantage of a patient’s vulnerability in that Respondent utilized unproven drugs and medicine to treat AC, a pediatric patient diagnosed with autism.
30. That the foregoing acts and/or omissions of Respondent are grounds for revocation or suspension of a Certificate of Registration pursuant to 225 Illinois Compiled Statutes (2002), Section 60122(A)(20), relying on the Rules for the Administration of the Medical Practice Act, Illinois Administrative Code Title 68, Section 1285.240(b)(1 )(C), and (2) (C).

There are many methods by which “heavy metal toxicity” is diagnosed by alternative medical practitioners. These methods are not demonstrated to be accurate, and are not accepted by actual medical toxicologists. These include hair analysis, provoked urine testing and porphyrin testing.

A prime example is provoked urine testing. A thorough discussion can be found here. A provoked urine test involves giving an individual a chelator and then testing the urine for heavy metals. Everyone (every thing, every animal) has some level of mercury. A chelator will force the body to excrete some level of the heavy metals inside, so it is no surprise that the levels obtained are “elevated”. The problem is that there is no standard by which one can compare the provoked urine to determine if the person actually has heavy metal poisoning.

The method is also called “challenge” testing. The American College of Medical Toxicologists have a position statement on this:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

More quotes from the complaint:

From Count III

That Respondent made false or misleading statements regarding the efficacy or value of the medicine, treatment, or remedy prescribed by Respondent in the treatment of any disease or other condition of the body in that Respondent made false or misleading statements regarding the efficacy of chelation therapy in the treatment of autism.

From Count V

29. That Respondent engaged in a pattern of practice or other behavior that demonstrates incapacity or incompetence to practice in that Respondent:
a. Repeatedly prescribed and administered unproven and medically unnecessary treatments to AC despite the lack of empirical research demonstrating the effectiveness of the prescribed treatment plans; and
b. Demonstrated extreme departure from rational medical judgment in the care and treatment of AC.

This isn’t a criminal complaint. Rather it is an ethics or “professional regulation” complaint. The disciplinary action called for if the case is proven involves Dr. Usman’s license:

WHEREFORE, based on these allegations, the Department of Financial and Professional Regulation of the State of Illinois, by Laura E. Forester, its Chief of Medical Prosecutions, prays that the Physician and Surgeon license of ANJUM I. USMAN, M.D., be revoked, suspended, placed on probation or otherwise disciplined.

Illinois charges DAN doctor with unethical behavior

13 Oct

According to the Chicago Tribune, the Illinois Department of Financial and Professional Regulation has charged a well-known Naperville physician with “unprofessional, unethical and/or dishonorable conduct.”

Dr. Anju Usman, a familiar face at anti-vaccine conferences in the US and abroad,   allegedly lied about or exaggerated the value of treatments, and “demonstrated extreme departure from rational medical judgment” and “abused the patient/physician relationship.” Regulators are moving to have Usman’s medical license revoked or suspended, or otherwise disciplined.

The report, written by science writer Trine Tsouderos, says:

The complaint, filed Wednesday, revolves around Usman’s care of a boy diagnosed with autism whose treatment was described in the Tribune’s series “Dubious Medicine.” The series detailed the many unproven therapies prescribed for the boy and found that many alternative treatments for autism amount to uncontrolled experimentation on children.

According to the complaint, the boy began seeing Usman shortly after he was diagnosed with mild to moderate autism in the spring of 2004. He was not yet two.

Usman allegedly diagnosed the child with a calcium-to-zinc imbalance, yeast, dysbiosis, low zinc, heavy metal toxicity and abnormally high levels of aluminum, antimony, arsenic, cadmium, copper, lead, nickel, silver, tin, titanium, and selenium.

Dr. Anju Usman

Usman is the defendant in a civil suit filed by the boy’s father in 2010. Also named are Dan Rossignol, a Florida DAN doctor; and Doctors Data, a Chicago-based laboratory that performs tests used to convince patients that they have dangerously high levels of lead, mercury, or other heavy metals that require “detoxification” to reduce these levels.

Usman is also associated with the 2005 death-by-chelation of five-year-old Tariq Nadama. According to court records, Usman diagnosed the boy with “high aluminum” and referred him to Roy Kerry, a Pennsylvania physician. Kerry, an ear-nose-and throat surgeon, inexplicably treated the boy for lead poisoning.

According to Kerry’s notes, which were published by the Pennsylvania Medical Board:

“We don’t have the entire record at all. Mother left her entire volume of his records home. But we have been in communication with Dr. Usman regarding EDTA therapy. He apparently has a very high aluminum and has not been responding to other types of therapies and therefore she is recommending EDTA, which we do on a routine basis with adults. We therefore checked him to it … But on testing for the deficiency indicator we find him only indicating the need for EDTA at the present time. Therefore we agree with Dr. Usman’s recommendation to proceed with the treatment. She recommends 50mg per kilo. He is 42 pounds today. So we’ll treat him with a 20-kilo child and give 1 gram of EDTA.

Nadama arrested and died in front of his mother during the third chelation round in August, 2005. A year later, Kerry was certified as a DAN doctor after completing an eight-hour training course. Prosecutors declined to charge Kerry for the death, and the state medical board suspended his license for six months and ordered extra training.

Usman spoke at AutismOne in Chicago last May, a cult-like annual gathering that expels skeptical writers and news reporters. Her topic: Prevention & Raising Healthy Kids in a Toxic World.

Generation Rescue: taking another small step away from the brink?

14 Jul

Generation Rescue has over the years been one of the more vocal promoters of the vaccines-cause-autism notion. Like any organization, they have changed over the years and their website reflects that. Their website started out with the title “Autism Mercury Chelation” and a very simple (and wrong) statement:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.

Of course, later during the early years of Jenny McCarthy, when Generation Rescue became “Jenny McCarthy’s autism organization. By this point, GR had a prominent link on the main page to “vaccines”. This included a page with Generation Rescue recommended vaccine schedules. Their “favorite” being a schedule that offered no protection against many diseases, including measles, mumps, rubella, pertussis, diptheria and tetanus.

They had a page of “science”, including statements claiming that Andrew Wakefield’s 1998 paper linked MMR to autism (a position Mr. Wakefield has tried to distance himself from in the past few years):

“This study demonstrates that the MMR vaccine triggered autistic behaviors and inflammatory bowel disease in autistic children.”

They had a science advisory board, which included S. Jill James, Ph.D., Richard Deth, Ph.D., Woody R. McGinnis, M.D. and Jerry Kartzinel, M.D.. Not exactly heavy hitters, but at least a couple of people who actually publish in journals.

Times have changed again. The website is revamped. And vaccines seem to be much less prominent. For example, in the current version of the Generation Rescue website, I can’t find “recommended” vaccine schedules (they refer people to Dr. Bob Sears). A search for Wakefield shows he is only mentioned once “Studies by researchers: Horvath, Wakefield, Levy, and Kushak highlight a myriad of gut problems present in children with autism, including abnormal stool (diarrhea, constipation), intestinal inflammation, and reduced enzyme function”. The science advisory board is down to one person (Jerry Kartzinel) and an unnamed “cohesive group of professionals committed to healing and preventing autism”.

Sure, it’s still not a place I would recommend to anyone, especially a parent who just found out their kid is autistic. But just a few short years ago the trajectory was increasing with the vaccine discussion, not decreasing.

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

Chelation: oral not very effective, IV causes brain fog

10 Feb

One very common therapy in the Complementary and Altenative Medicine (CAM) world is chelation. It has been very popular amongst DAN doctors and other CAM practitioners in the autism community, largely based on the mistaken ideas that (a) autism symptoms are similar to mercury poisoning and (b) autism is caused by mercury (from vaccines and elsewhere).

I’ll say it here and I’ll repeat it at the end of this piece: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.

That said, here are two articles I’ve run across recently which reminded me of why people should seek experts. First, the most common oral chelating agent (DMSA, succimer) is not very effective against mercury. Second, IV chelation can result in “brain fog” lasting days.

An NIH Research Matters article titled “Lead Poisoning Treatment Less Effective for Mercury” discusses measurements of blood mercury levels in children in a trial of chelation for high lead levels.

A drug commonly used to treat lead poisoning is relatively ineffective at removing mercury from the blood. The finding provides insight into a compound currently being used as an alternative therapy for autism.

Here are the concluding paragraphs:

A research team led by Dr. Walter Rogan at NIH’s National Institute of Environmental Health Sciences (NIEHS) sought to investigate whether succimer can also remove mercury from the blood. The team used blood samples and data from 767 children, aged 12 to 33 months, who participated in an earlier clinical trial of children who were treated for high blood levels of lead.

The research team measured mercury concentrations in blood samples collected prior to treatment, a week after beginning treatment with succimer or placebo, and again after 3 month-long courses of treatment. The study was funded by NIEHS, NIH’s National Institute for Minority Health and Health Disparities (NIMHD) and the Centers for Disease Control and Prevention. The results appeared online on October 1, 2010, in the Journal of Pediatrics.

The researchers found that, after 1 week, succimer lowered blood concentrations of mercury by 8%. In contrast, it reduced blood lead concentration by 42%. After 5 months, those taking succimer had blood mercury concentrations about 20% lower than the control group. However, the therapy had only slowed the rate at which the children accumulated mercury.

“Succimer is effective for treating children with lead poisoning, but it does not work very well for mercury,” Rogan says. “Although succimer may slow the increase in blood mercury concentrations, such small changes seem unlikely to produce any clinical benefit.”

In an article in Integrative Medicine, Joseph Pizzorno (a leading naturopath) talks about his experience with IV DMPS.

Unfortunately, my first experience with IV DMPS at the normal dosage (250 mg) resulted in significant “brain fog”. I experienced obvious impaired memory and decreased cognitive capacity for several hours (my wife asserts she noticed effects for a full week).

He goes on to tell that even though he believes that overall he is doing better due to lower mercury levels, his team asked him to refrain from IV chelation before meetings. His colleagues were able to see the obvious adverse effects (Dr. Pizzorno refers these as “adverse IV chelation effects”)

I repeat this here: any parent who believes his/her child is a victim of heavy metal poisoning should take that child to a medical toxicologist. Find an expert in toxicology. This is not a project to take on yourself and your child deserves the best. Find someone trained and experienced in toxicology. You can search by state or country.

Safeminds defends treatments the FDA deemed “dangerously misleading”

18 Oct

The United States Food and Drug Administration (FDA) recently announced that they had sent warning letters to eight groups who were promoting chelation products without prescriptions and with unproven claims of efficacy.

Chelation is a mainstay of many alternative medical practitions, especially in autism. There is a hypothesis that autism is caused by mercury poisoning. Autism symptoms don’t look like mercury poisoning and multiple studies have been performed testing the hypothesis and shown no link. But the idea lives on. Autistics, mostly children, are subjected to chelation “therapy” to remove heavy metals from the body. After over a decade of this practice, there is still no demonstration that chelation does anything to help autistics. There are studies on Peruvian hamsters which are used to support the idea that autism is caused by mercury poisoning. No, seriously, one of the supports for the mercury/autism link is a study on Peruvian Hamsters. Just goes to show how tenuous the “science” backing chelation is.

Here is part of the FDA statement:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

One of the more vocal organizations promoting the mercury/autism “link” is a group called SafeMinds. So it isn’t a surprise that they would respond to the FDA warnings..

Here is the opening paragraph from the SafeMinds response:

The FDA issued a media release and held a press conference on over-the-counter chelating products. A recording of the press conference was made available this afternoon (recording available at 800-839-7073). FDA issued warning letters to 8 companies promoting over-the-counter nutritional supplements for chelation therapy (HERE). Chelation is a method of removing heavy metals from the body. The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.

“Nutritional Supplements”? How does a chelator count as a “nutritional supplement”? The human body does not produce chemicals like DMSA which are used for chelation. SafeMinds is well aware of the falacy of the “nutritional supplement” argument after the recent debacle over the chelator turned “supplement” OSR, which had to be pulled from production.

So, SafeMinds starts downplaying the fact that chelators are drugs and, as such, should be regulated.

But they quickly change the tune and acknowledge that these are drugs: “The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.”

As I read this, I had to ask myself “Why did SafeMinds chose such imprecise language?” Let me explain:

Assume a medical professional, say a chiropractor or a nutritionist, “supervises” my use of the prescription drug DMSA, but sells the drug to me without a prescription (as these professionals can not write prescriptions). That would fit into the SafeMinds interpretation, but is clearly not the intent of the FDA statement.

Here is an accurate statement: The FDA warning does not have bearing on the use of chelation drugs prescribed by and supervised by a medical professional.

Continuing with the SafeMinds statement:

In its press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor’s supervision, but on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous and could lead to kidney damage, dehydration and death. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used.

Note that SafeMinds chose their words carefully. They don’t state that the practice doesn’t occur. SafeMinds just states that the FDA didn’t have the evidence on hand of the “use of OTC chelation products by autism parents or of their use without medical supervision.”

Is Safeminds so out of touch with the online autism community that they can’t find groups promoting over-the-counter (OTC) chelators by autism families? The practice is common. Surely SafeMinds members peruse the exhibitor booths at the parent-conventions (like Autism One).

Google search: “how to buy DMSA without a prescription”. Lot’s of hits.

Here is hit #2: dmsachelation.com/autism/. Pretty clear they are targeting autism treatment there, just from the URL. The blurb on Google for this site? “This page IS intended to show you where to buy DMSA without a prescription. You can get DMSA prescribed, however the cost will range from $2-3 per pill. …”

I didn’t capitalize “IS” in that statement, they did. They wanted to emphasize that one could buy chelators without a prescription.

SafeMinds states that the FDA has received no reports of adverse events from chelation in general. I find this odd. The FDA must not follow online autism parent groups such as those on Yahoo. The FDA must not have read transcripts of the Omnibus Autism Proceeding, which included a description of a child who regressed after being given chelation therapy (under the watchful eye of a prominent alt-med doctor). The FDA must not have performed a google search on chelation deaths with site set to CDC.gov.

First hit, “Deaths Associated with Hypocalcemia from Chelation Therapy — Texas, Pennsylvania, and Oregon, 2003–2005“.

When it comes to the question of “why” adverse events are not commonly reported I am again reminded of the OSR fiasco. The company that sold OSR specifically told their clientele to contact the company in case of adverse reactions. No mention was made of contacting the FDA (which can be done here). I guess I could search the websites of the groups that promote OTC chelators to see if they inform their clients of the ability to report their drug/supplements to the FDA. Somehow I feel confident that I would be able to find groups (possibly many or most) do not give that information.

SafeMinds posted their statement on the blog they sponsor, The Age of Autism. Another sponsor of that blog is Lee Silsby, a compounding pharmacy. They list chelators such as DMSA and EDTA under the category “autism treatments” (Specialties | Autism Treatments | Transdermal DMSA Cream, or Specialties | Autism Treatments | EDTA (calcium)). Not under “heavy metal poisoning” treatments, autism treatments.

The Autism Research Institute, a group which promotes much in the way of alternative medicine as therapies for autism, has a chart that is often used to promote chelation. In their survey, they claimed that over 70% of parents reported that their child got better with chelation. The survey has been often criticized as being unscientific and very biased. Even with this biased sample, 3% of parents reported that their child “got worse” with chelation.

A couple side notes are worth mentioning. First, in that survey the ARI list chelation under “Biomedical/Non-Drug/Supplements”. Non drug? Supplement? I doubt the FDA will agree. Second, the ARI survey lists secretin therapy as beneficial for autism. Secretin hit the news in the 1990’s as a potential autism therapy and has since been shown to be no more effective than a placebo. The survey is very, very biased towards “biomedical” treatments.

Surely SafeMinds is aware of this survey. As in, definitely they are aware of it. Just as Safeminds are certainly aware of the child in the Omnibus proceeding who suffered after chelation. But SafeMinds pretend as though there are no adverse reactions. It is disingenuous, to say the least.

SafeMinds ends their statement with this paragraph:

SafeMinds agrees with the FDA that products being promoted as drugs and biologics should have thorough and unbiased assessments for safety and that parents should work with their healthcare professionals when considering health interventions. SafeMinds feels that FDA has tried to cast autism parents in a negative light without any supporting evidence, by implying that autism parents were giving their children dangerous products without medical oversight. Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.

Basically, SafeMinds have taken the Human Shield defense. Rather than actually discuss the facts, SafeMinds attacks the FDA for “wild claims” and claims that the FDA owes the autism community an apology.

From the perspective of this autism parent I would say, yes, the FDA owes us an apology: for taking so damned long to address this issue. The abuse of chelation as a “treatment” for autism has been going on for many years. It is about time that the FDA cracked down and made the “wild claim” that a prescription drug should be given by perscription.

Heck, the FDA isn’t even making the “wild claim” that toxicology treatments should be performed by toxicologists. Just someone with a prescription pad.

Why isn’t SafeMinds telling autism families to seek out medical toxicologists to test and treat heavy metal poisoning? The answer is painfully clear. The methods of diagnosis and treatment that groups like SafeMinds promote do not compare to the methods used by those trained specifically to treat heavy metal intoxication.

Should make one pause to wonder.

FDA: Chelation not proven safe or effective in treating autism

14 Oct

Chelation is a process whereby metals are removed from the body using a drug, a chemical which binds to the metals and allows them to be excreted. Because of the incorrect notion that autism is caused by mercury or is a “novel” form of mercury poisoning, chelation is one of the more common alternative medical therapies applied to autistics.

The FDA has recently issued a warning to many of those who market unapproved chelators. Two articles appear on the FDA website today:

FDA Tightens Reins on Unapproved ‘Chelation’ Drugs

and a press release

FDA issues warnings to marketers of unapproved ‘chelation’ products.

They have also issued a printer-friendly pdf: FDA chelation warning pdf

From that pdf:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease by removing toxic metals from the body.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

The groups that have been warned are:

• World Health Products, LLC: Detoxamin
Oral, Detoxamin Suppositories, and the
Metal Detector test kit
• Hormonal Health, LLC and World Health
Products, LLC: Kelatox Suppositories,
and the METALDETECTOR Instant Toxic
Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy
Metal Chelator, Bio-Chelat Heavy Metal
Chelator, Behavior Balance DMG Liquid,
AlkaLife Alkaline Drops, NutriBiotic
Grapefruit Seed Extract, Natur-Leaf,
Kids Clear Detoxifying Clay Baths, EBN
Detoxifying Bentonite Clay, and the
Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories:
PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx,
Anavone, AV-Rx, BioGuard, BSAID, CF-Rx,
CreOcell, Dermatotropin, Endotropin,
GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge,
PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and
the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and
CardioRestore
• Artery Health Institute, LLC: Advanced
Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation
Improved, EndoKinase, Viral Defense,
Wobenzym-N
• Dr. Rhonda Henry: Cardio

I wonder how the FDA chose these groups for the first round of warnings. I also wonder if/when there will be more warning letters.

Also from the FDA pdf:

FDA says consumers should avoid nonprescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.

I don’t know why the FDA has taken so long to step in and take action. Chelation has been going on for years, and has never had a sound basis in science or even a good rationalization for the treatment of autism.

Trine Tsuderous has an article on the Los Angeles Times website, FDA warns about treatments for autism, heart disease.

Eli Lilly halts two clinical trials of an experimental Alzheimer’s treatment

19 Aug

This has been reported in a number of places, including the New York Times in their article Lilly Stops Alzheimer’s Drug Trials.

From the NY Times:

Eli Lilly halted two late-stage clinical trials of an experimental Alzheimer’s treatment on Tuesday, representing a setback to one leading theory on treating the degenerative disease and a new blow to Lilly’s business prospects.

One defining feature of Alzheimers disease is the presence of amyloid plaque in the brain. The now-halted clinical trial was for a drug which reduces this plaque.

The basic idea is fairly straightforward: if plaque is present in the brains of those with Alzheimer’s, removing the plaque may help reduce or reverse the symptoms. Instead, researchers were finding that the drug was making symptoms worse. Again from the times:

The company said patients who had taken the drug, intended to reduce plaque in the brain, actually showed worse cognitive functioning and less ability to perform daily living tasks than patients who had taken a placebo.

Why bring this up on an autism blog? Because this trial gives a good example of why I am very concerned about the use of untested therapies on autistics. It isn’t because of some objection to a “cure”. There is no existing autism cure. There is no autism cure proposed or in any stage of a clinical trial. While there is some very good and important discussions about any potential cure, it is for the present a hypothetical discussion. No, it isn’t the cure debate which drives me. It is safety. Plain and simple.

Consider autism therapies (both alternative and off-label) from a viewpoint of safety for the moment with the lessons learned from the Alzheimer’s trial.

Clinical trials are all about safety and efficacy. Is the therapy (drug) safe? Does it work? Before a clinical trial is even started, there has to be some reason to believe that the therapy would be safe and effective. Researchers have to ask the question, “what will this do?” In the Eli Lilly Alzheimer’s trial, they had reason to believe that the drug would reduce amyloid plaque. They had (I assume) some earlier trials to prove the drug reached some level of safety. With that in hand, Eli Lilly went forward to large-scale testing with people and they found that, at least for their test group (people with somewhat advanced Alzheimer’s disease), the drug was harmful.

From the NY Times story:

Lilly’s drug was intended to reduce production of so-called amyloid beta plaques in the brain by inhibiting the activity of an enzyme called gamma secretase.

Dr. Siemers of Lilly said the failed trials might indicate that too much reduction in amyloid beta unexpectedly harms cognitive functions, or it may be that the problems arose from the drug’s effect on some 20 other proteins.

Unintended and unforeseen consequences.

Consider alternative therapies being applied to autistics. For example, consider anti-inflammatory drugs. These are existing drugs used off-label, so some safety data are available. There is evidence of inflammation in the brains for some autistics, so why not treat it?

Because we don’t understand why there is inflammation in the brains of autistics. Because of that, we don’t know if there are any unintended consequences of anti-inflammatory therapies. From a story last year in the Chicago Tribune, this section discussing the team from Johns Hopkins/Kennedy Krieger which first published on neuroinflammation in autistics:

“THERE IS NO indication for using anti-inflammatory medications in patients with autism,” the [Johns Hopkins] team wrote.

Meddling with neuroinflammation could actually be a terrible mistake, said co-author Dr. Andrew Zimmerman, director of medical research at the Center for Autism and Related Disorders at the Kennedy Krieger Institute in Baltimore.

“It may actually be an attempt of the brain to repair itself,” said Zimmerman, a pediatric neurologist. Suppressing the immune response “could be doing harm.”

There are other classes of alternative therapies used in autism. Therapies which most likely are doing nothing beyond the placebo effect are in one class. For example, homeopathy. I don’t spend a lot of time writing about homeopathy. In fact, I don’t know if I have blogged about it at all. Even though it is bad science, it isn’t really dangerous. Another class of alternative therapies are those based in really bad science and which carry the potential of harm. Lupron comes readily to mind. Lupron therapy is based on two levels of very bad science. First, that autism is caused by mercury poisoning. Second, that reducing testosterone in the body will aid it in eliminating mercury. Lupron has been through clinical trials (not for autism) demostrating some level of safety, there are serious known side effects. Worse, the manner in which it is used in autistic children is very problematic–delaying puberty.

Back to the Alzheimer’s trial–I actually welcome the trial itself. I consider those who undertake clinical trials to be very brave individuals. I for one hope there are effective therapies for Alzheimer’s and other forms of dementia soon. It is a great fear for most, if not all, of us that we spend the last years of our lives with dementia. For the parent of a disabled child, this fear is only compounded. The thought of spending my last years draining resources I would rather leave to my child is one of the worst futures I can imagine.

OSR pulled from the market….or is it?

3 Aug

Here on LeftBrainRightBrain we recently discussed a letter from Boyd Haley, Ph.D. announcing his decision to voluntarily remove his product, OSR #1 from the market. The letter from Mr. Haley stated (in part):

The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

The CTI website is down, and has been for a few days. The message I get when try it is:

HTTP Status 404 –

type Status report

message

description The requested resource () is not available.

Two locations I checked are still selling OSR.

The Forrest Health site has the letter from Mr. Haley noting that he has pulled the product from the market. They not only let you buy it, but they require that you purchase 3 or more “Note: you must order at least 3 items”.

Living Well International has OSR on their site as well. In response to my email, they response to my email request, “Do you still have OSR#1 for sale?”, they responded “Yes we do. It is $60 for a box of 30”

I do wonder how long before someone decides to make his or her own batch of OSR. Mr. Haley has been quoted as stating it was not difficult. The published recipe for the chemical indicates a few potential concerns. First, the chemicals are themselves not without hazards.

Triethylamine

Liquid causes first degree burns on short exposure; [CHRIS] Corrosive to skin; [Quick CPC] Short-term exposure at high concentrations may cause pulmonary edema. [ICSC] A lachrymator; [CHEMINFO] Experimental animals exposed repeatedly to 100 ppm show evidence of liver, kidney, lung, and heart damage. [HSDB] A corrosive substance that can cause pulmonary edema; [ICSC]

Chloroform has relatively high LD50 values (the amount where 50% of exposed animals die). But the MSDS lists reproductive toxicity as:

Birth defects have been seen in rats and mice exposed by inhalation of chloroform at concentrations greater than 100 ppm in air. Ingestion of chloroform by pregnant laboratory animals has resulted in fetotoxicity but not birth defects, and only at levels causing severe maternal effects.

Isophthaloyl chloride is only listed as an eye/skin irritant. I won’t go down the list of all the chemicals. I think you get the idea. It is likely that a competent chemist with a reasonable laboratory (including a fume hood and access to nitrogen gas) could produce “bathtub OSR” reasonably safely. I frankly cringe at the thought of someone attempting this at home. I will add, the yield of the published process for producing this chemical is about 72% without optimization. This begs the question to me as to how clean the product is in this form.

Desiree Jennings back in the news

26 Jul

Remember Desiree Jennings? She was a cheerleader ambassador for the Washington Redskins who claimed that a flu shot gave her dystonia. She was highlighted by the Age of Autism blog and by Generation Rescue, who connected her with alternative medical practitioner Rashid Buttar. Mention of Desiree Jennings has been removed from the Generation Rescue website. Neurologist and blogger Steve Novella discussed how her case more closely resembled a psychogetic disorder. Dr. Novella’s take on the case prompted the American TV show Inside Edition to take a second look. We discussed the Jennings case then here on LeftBrainRightBrain as Successful blogging by Steven Novella: the Desiree Jennings story
.

Now the TV Show 20/20 has taken a look a the Desiree Jennings story in Medical Mystery or Hoax: Did Cheerleader Fake a Muscle Disorder?

First, one must stress that many people following this case have not been calling out “hoax”. A psychogentic disorder is quite real, just not dystonia and not physical.

That said, here is the trailer for the 20/20 episode:

http://abcnews.go.com/assets/player/walt2.6/flash/SFP_Walt.swf

I find the beginning to be really cheesy. The way they took the video to make it look like it was some film taken decades ago was, well, cheesy. Ms. Jennings is less than 30 years old. Somehow I doubt her wedding was recorded on film and, even if it was, it wouldn’t be so deteriorated in a few years. But, we get the idea–the wedding was in the past.

Ms. Jennings has been used as an example of how successful Rashid Buttar is. One article, copied to Dr. Buttar’s blog, states that shortly after beginning treatment with him:

The good doctor ran to his patient, fearing she had suffered another seizure but instead was elated to find that she was awake, coherent and carrying on a normal conversation with the nurses and her family. By the next day she was walking the corridors with limited affliction. (See the video at: http://www.desireejennings.com.) The AMA has remained silent.

(note–www.desireejennings.com is no longer active).

But just as she was leaving Dr. Buttar’s clinic on her last visit in December 2009 — with “20/20’s” cameras rolling — it all seemed to fall apart. Jennings was in distress again. She could no longer walk forward, and had to be taken out in a wheelchair.

In the early discussions of Ms. Jennings, much interest focused on the idea that she was diagnosed with Dystonia by doctors at Johns Hopkins. People complained that Dr. Novella shouldn’t make statements that contradicted doctors who actually saw Ms. Jennings. The 20/20 story states:

In search of a cure, Jennings and her husband Brendan visited countless doctors and four hospitals, among them Johns Hopkins Hospital. There, a rare movement disorder that causes the muscles to twitch or convulse involuntary. The symptoms resembled her own.

“a physical therapist told Jennings about dystonia”. That’s a bit different from a doctor diagnosed her with dystonia.

Yes, this isn’t about autism at all. But this story does shed some light onto groups like Generation Rescue who supported Desiree Jennings, sending her to Dr. Buttar. The story was compelling for them, even though it was not about autism. It was about alleged vaccine injury. Generation Rescue appears to have abandoned Ms. Jennings now. It sheds light on Dr. Buttar, whose claims of recovery for Ms. Jennings appear to be unsupported by the facts. Dr. Buttar is one of the more prominent names in the alternative medicine community marketing their services to the autism community.

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