After a long, long wait, the BCA finally published its list of ‘evidence’ on the Simon Singh case. Read the Lay Scientist’s appraisal for an indication of how poor the evidence is. It consists entirely of irrelevant articles and poor studies but there was one paper that no-one could find. It is by Joan M. Fallon and is supposed to show “a strong correlation between the chiropractic adjustment and the resolution of otitis media for the children in this study”, according to the BCA press release. A copy (google cached version) finally emerged on the 2nd July and it doesn’t look good.
I figure that the leading bloggers of the bad science community will do the paper’s criticism more justice than I would be able to (especially seeing as I don’t currently have institutional access to journal articles). Gimpy has already pointed out that he was entirely correct when he judged it according to the abstract (the main point being the lack of a control group) and also pointed out some simple errors in data handling that demonstrate the clear lack of a rigorous approach to science.
I note that there’s no statement about a conflict of interest – I guess the Journal of Clinical Chiropractic Pediatrics (JCCP) can’t really have a conflict of interest statement, as it is a journal published by the International Chiropractors Association (ICA) Council on Chiropractic Pediatrics (CCP), one of whose stated goals is that “the Council endeavors to educate the public about the safety, efficacy,and appropriateness of chiropractic care from infants to adolescents.” (grammatical error is not mine). The parent organisation, the ICA, was set up explicitly to lobby for the adoption of chiropractic – not exactly a balanced scientific organisation.
It all seems quite incestuous to me: according to this notice from the Palmer College of Chiropractic (where she got her Doctor of Chiropractic – D.C.) Fallon is a co-founder of the ICACCP who then published her landmark paper in her own journal. She was chair of the ICACCP at some point, although I don’t know whether this was at the time that she did her ’study’. She is also listed as one of the most important sponsors of the ICACCP.
While I was looking around I found some reports that she had written a book called “The Textbook of Chiropractic and Pregnancy” (also mentioned in the Palmer College notice above) before writing the infamous paper. If true then that represents a possible further conflict of interest (although I guess the rules are a little stretched here). Interestingly, I couldn’t find the book listed anywhere on the internet (although it recieved plenty of mentions on various chiropractic websites). It also isn’t listed in the Cambridge University Library’s catalogue which, to my knowledge, has a copy of close to every book published in English. I have sent them an email to check this, and will update as soon as I get a reply. The other book mentioned in the Palmer College notice was also mysteriously absent.
This brings me to another point: a PubMed search for “Joan Fallon” returns only one article titled “Could one of the most widely prescribed antibiotics amoxicillin/clavulanate “augmentin” be a risk factor for autism?”. At the top of the page is a note saying that the article was commented upon later in the same journal. The title of the comment is “Antibiotic not linked to autism.”. Unfortunately, I can’t read any further because I don’t have institutional access for the next two weeks.
Joan Fallon is frequently described as having done lots of important research in the field of chiropractic, although she seems to have moved to other areas recently, but her only PubMed result is something unrelated. Where on earth was all this research published?
I apologise for this ad hominem attack, but it strikes me that she may have published this paper in her own journal, further undermining the quality of its science.
JOAN M. FALLON, D.C., F.I.C.C.P. (1997). The Role of the Chiropractic Adjustment in the Care and Treatment of 332 Children with Otitis Media Journal of Clinical Chiropractic Pediatrics
*Update*
My apologies, it turns out that the textbook does exist: the Cambridge University Library doesn’t have a copy because “the publishers, the International Chiropractors Association, is an American body, so we it is unlikely that we would have been able to acquire it under copyright.”. Published in 1994 (three years before the study), this book would presumably have increased sales if more people think chiropractic works.
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July 3rd, 2009 at 10:02 am
Good work Colin. I’d commented on Joan Fallon’s views on autism over at Bad Science.
http://www.badscience.net/forum/viewtopic.php?f=3&t=9818&p=196534&hilit=fallon#p196534
The link between antibiotics, ear infections and autism is that she is proposing that wicked doctors giving children antibiotics for ear infections cause autism – much safer to use chiropractic, of course. She also accords to the Wakefiled aetiology model.
May 12th, 2010 at 10:26 pm
Our research indicates from New York State Government Filings that Dr. Joan Fallon, a Chiropractor, had offices on 830 Pelhamdale Avenue in New Rochelle, New York 10801 (914) 576-2300 and at 1234 Central Park Avenue in Yonkers, New York (914) 779-9300.
Her last associate that worked with her was Dr. Greg Werner http://www.drgregwerner.com He took over Dr. Joan Fallon’s practice and moved it to
696R Post Road, Scarsdale, NY 10583.
We personally know 6 patients that attended one or both of these offices for Chiropractic care and whenever they needed a copy of their record, at least one of her office staff members, an older woman, would state that she was not a good record keeper and no one ever saw her write or type out any notes.
We find it very hard to believe that she could write this paper which such poor records.
Our latest inquiry’s show that she is the President & CEO of Curemark, a Biotechnology Company on Theodore Fremd Avenue in Rye, New York.
November 10th, 2010 at 12:51 am
Dr. Joan Fallon DC was a Chiropractor at 830 Pelhamdale Avenue in New Rochelle, New York. She shared her Chiropractic practice with Dr. Deborah Gioe DC. Dr. Joan Fallon also worked along side Dr. Martha Edelman, a Family Medical Doctor. While at this practice, Dr. Joan Fallon ordered Secretin, an injectable hormone from Ferring Pharmaceuticals in Tarrytown, New York. This Pharmaceutical company has since relocated to 4 Gatehall Drive,Third Floor Parsippany, NJ 07054. Records of this hormone being purchased by her office is available at their Pharmaceutical Company.
Dr. Joan Fallon hired nurses to inject Secretin, a hormone, to several children from her practice that Autism. Chiropractors are not supposed to be involved with the administration of drugs. Dr. Fallon also charged large sums of money for these children to be injected. She worked in association with a Pediatrician, Dr. Rose Ghersin MD who now practices at 293 Route 100 # 104, Somers, NY 10589-3215 (914) 277-3360. Dr. Fallon’s research and information on treating children with Autism stemmed from her friend, Dr. Arlene H. Feltenstein (Maletta) PhD who used to live in Larchmont, NY but now lives in Scottsdale, Arizona. Our research shows that she authored 2 books with Dr. Feltenstein. Although Dr. Joan Fallon has patents issued on what Dr. Feltenstein has taught her, she is not listed on these patents. A listing of Dr. Joan Fallon’s patents can be found on the internet.
Dr. Joan Fallon abruptly left her New Rochelle office and opened a Chiropractic office at 1234 Central Park Avenue in Yonkers, New York. She shared her practice with Dr. Greg Werner DC another Chiropractor. She left her Chiropractic office and gave her patient’s to Dr. Werner who then moved his practice to 696R Post Road, Scarsdale, New York.
Dr. Joan Fallon then opened up a Biotechnology Company, Curemark LLC located at 411 Theodore Fremd Avenue in Rye, New York. (914) 925-3450
With research at our core, our team will keep you informed.
November 12th, 2010 at 9:57 pm
This is to inform the public since there are articles citing that Joan Fallon was conferred a Masters Degree from our Institution. To clarify, Joan Fallon attended classes at the MGH Institute of Health Professions here in Boston, Massachusetts. She was enrolled in the Masters of Science program for Clinical Investigations but she dropped out in 2004 and never received her Masters Degree.
We no longer have the Clinical Investigations degree offering. We welcome you to contact us on any further information.
(617) 726-2947 Main
MGH Institute of Health Professions
36 First Avenue
Charlestown Navy Yard
Boston, MA 02129-4557
November 14th, 2010 at 11:33 pm
New autism study: science or nonsense?
Category: Medicine
Posted on: April 6, 2010 2:10 PM, by PalMD
Bad medical ideas often start with good intentions. Most doctors are interested in preventing and treating disease, and some diseases are particularly challenging. Some rise to this challenge, forming clever hypotheses and finding accurate ways to test them, but others aren’t so successful. Sometimes, hypotheses are too implausible to be worth spending much time on. Sometimes, the method used to test a hypothesis is simply not valid.
This story begins on the website Age of Autism. AoA is one of the homes of the antivaccination movement and gives a lot of time to those who still believe that vaccinations and other “toxins” cause autism. The site is full of remarkably paranoid rants. When Chicago Tribune journalist Trine Tsouderos won an excellence in health care journalism award, AoA accused the CDC and Trib of having “bought” the award. They are boosters of every unproven and implausible “treatment” for autism, such as chelation, hyperbaric oxygen, and chemical castration through lupron injections. Recently, they provided a platform to Dr. Andrew Wakefield, the physician who’s Lancet paper drawing a link between autism, vaccinations, and gut disorders, was formally withdrawn by the journal’s editors. Due to accusations of scientific and ethical misconduct, he is likely to lose his license to practice medicine in England.
So it came as no surprise to see one of their writers hyping a study in progress that is testing oral enzymes for the treatment of autism. In the piece, Theresa Conrick incorrectly implies that the existence of this study is vindication for both the autism-gut hypothesis and for Wakefield’s behavior.
*******
In 1998 Dr. Andrew Wakefield published a paper in the prestigious medical journal the Lancet. In this study, he claimed that the measles, mumps, rubella (MMR) vaccine caused observable changes to children’s intestines which eventually lead to autism. The study led directly to falling vaccination rates in the UK, an increase in vaccine-preventable disease, and helped launch the modern antivaccination movement in North American and Europe. The study, as it turned out, was so fraught with conflicts of interest and poor science that several of the authors dropped their association with it, and it was eventually withdrawn from the journal. Wakefield himself was lambasted by England’s General Medical Council for his unethical behavior associated with the study, and will likely lose his license to practice medicine.
Wakefield’s hypothesis about autism and gastrointestinal disease was never terribly plausible to begin with, and despite the retraction of his original study, there persists a belief in many parts of the autism community that the gut is somehow implicated in the development and treatment of autism. Wakefield still has many zealous adherents and dietary therapies for autism have grown in popularity. Jenny McCarthy attributes much of her purported success with her child to severe dietary restrictions which she recommends for others. So far, however, there is no good body of literature supporting any connection between gut disease, diet, and autism. A new study aims to change that.
According to the hyperbolic language of Age of Autism, you would think that the very existence of this study exculpates Wakefield and vindicates all of the pseudo-experts’ opinions about the causes of autism. But what is behind Age of Autism’s excitement?
The study is designed to evaluate the affect of “CM-AT”, made by Curemark, LLC, on the symptoms of autism in children. CM-AT is an enzyme with a proprietary delivery system that is supposed to help digest proteins.
There are a number of conditions for which orally ingested enzymes can be used. Lactose deficiency, a common condition in which someone can’t digest the primary sugar in milk, can be treated effectively by taking lactase with dairy meals. People with pancreatic damage can take pancreatic enzymes to help them digest certain carbohydrates, fats, and proteins. Assuming that CM-AT actually breaks down proteins in vivo, what hypothesis underlies its use in autism?
According to the brief description at ClinicalTrials.gov:
Treatment is based upon the observation that many children with autism do not digest protein.
I’m unsure what literature supports this assertion. They do of course give references, but the reference are in large part either irrelevant to the hypothesis or of very poor quality. For example, one study looked at the co-occurrence of certain medical problems and autism, including GI problems, but the study failed to compare these rates to non-autistic children. Another looked at parental reports of abnormal stools in autistic kids. Neither of these gives a particularly strong foundation for a study of proteases in autism. Yet another study extensively quotes the work of Andrew Wakefield, the doctor who was censured in England for his unethical work. But the most interesting study is one done by Wakefield himself.
In this study, Wakefield reported that he had discovered “new variant of inflammatory bowel disease is present in this group of children with developmental disorders.” This was a number of years before his famously retracted study in which he blamed the MMR vaccine for autism, the same study for which he was censured. Before that controversy, a discussion in the journal Histopathology criticized Wakefield’s work, and practically accused him of lying about his methodology:
Sir: The histopathology proforma used for scoring of intestinal biopsies in the paper ‘Enterocolitis in children with developmental disorders’1 by Wakefield et al. receives detailed criticism in the Commentary, ‘Autistic enterocolitis, is it a histopathological entity?’,2 by MacDonald and Domizio. In his response Dr Wakefield states that ‘the proforma was designed by Professor A Dhillon of the Department of Histopathology, who with Dr A Anthony evaluated the sections for the purposes of completion of this proforma’.3
I neither designed the proforma being debated, nor was I a coauthor of the paper in which the proforma was published.
Given Wakefield’s subsequent troubles I find it curious that Curemark chose to cite this study in support of their work.
I spoke to Dr. William E. Gannon Jr. who is directing the study for Curemark. He has decades of experience running clinical trials. He reported to me that he is aware of the challenges sometimes associated with research into autism treatments and has worked closely with Curemark and the FDA to make sure this phase III trial is done right. He has been in continuous contact with study sites to make sure they stay on protocol and avoid inappropriate release of preliminary results.
But it would appear he is being hamstrung by Curemark, who is pumping up CM-AT before the phase III results are available. Their website currently links to a BusinessWeek article about the product:
“One of the most promising treatments in this category is a drug called CM-AT made by a startup called Curemark. Dr. Joan Fallon, the company’s founder and CEO, observed that many autistics show a strong preference for foods high in carbohydrates and low in protein. A diagnostic test revealed that some autistic children lack enzymes that digest protein. As a result, these children produce fewer of the essential amino acids that are the building blocks for brain development and neuroreception. Fallon believes this deficiency is linked to the most severe symptoms of autism, and she says an early observational study of CM-AT, an orally ingested powder that delivers protein-digesting protease, showed “significant improvements.” Curemark is enrolling patients in phase III clinical trials at 10 to 12 site the largest autism trial to date.” (emphasis mine)
Where did she get these ideas? What evidence supports this hypothesis? Who is Dr. Joan Fallon?
First, Fallon is not a doctor; she is a chiropractor. She is not exactly widely published in the medical literature. In 2005 she put a piece in Medical Hypotheses (a controversial journal, to say the least) in which she “hypothesizes” that the antibiotic Augmentin may be responsible for autism. She applied for a patent to use the commonly available laxative lactulose to treat autism. And she’s promoted the idea that autism is somehow related to the gut. None of her ideas really hang together. Is autism caused by a failure of protein digestion? By an antibiotic? By toxic ammonia levels? Whatever the cause, she seems to be looking for a profitable cure. I’m not sure that she can patent lactulose, but she apparently found a substance she can patent—CM-AT, a proteolytic enzyme in a novel delivery system.
There are a number of things I find disturbing about this study. While it appears to be well-run, it fails to conform to an important scientific and ethical standard: plausibility. According to the Helsinki Declaration protecting human research subjects:
12. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
Fallon and Curemark have not convinced me that there is any science that would justify their study. It’s certainly reasonable to take some risks based on sound science, but in this case, all that underlies this study is a handful of very questionable studies. Citing literature to justify your research is not just some bureaucratic hurdle to leap; it is fundamental to the ethical design of clinical trials. There is no reason to expect that delivering an oral protease to children with autism should improve symptoms of autism. There is no putative mechanism by which this should work, despite the speculations of the chiropractor CEO of the company that makes the product.
Given the low plausibility of the hypothesis, even positive results, should they be found, must be interpreted with a high index of suspicion. The statistics underlying the study of implausible hypotheses tell us that positive results are often due to chance or problems with study design rather than the drug being tested. This is not an esoteric technical detail. This is a study being done on child subjects whose parents have been led to believe this treatment may help. There is no reason to believe this is so. Perhaps some day if there are convincing preliminary studies, the current one would be justified. At this point, though, it is simply another questionable study built on a foundation of bad science.
November 15th, 2010 at 12:54 am
Dr. Joan Fallon is a chiropractor, why are there articles making remarks that she specializes in obstetrics and pediatrics? The article is located on a website from Canada since they refer to pediatrics as paediatrics.
http://theholisticpractice.com/chiro-amp-pregnancy.php
Chiropractic and Pregnancy – A Partnership for the Future
BY JOAN M.FALLON, DC
“About the Author of this article:
Joan M. Fallon, DC, F.I.C.C.P., is a graduate of Palmer College of Chiropractic.
Dr. Fallon has a private practice in Bronxville, New York, where she specializes in obstetrics and paediatrics.
She is an internationally recognized practitioner, teacher, writer and researcher on chiropractic paediatric care. She has a special interest in children with PDD and autistic spectrum disorders and has done considerable research in her practice to find the cause of their problems and ways to help them. Her research efforts to improve the lives of autistic children were recognized with a special commendation by the New York State legislature in 1995. Dr. Fallon has made an enormous contribution to the profession in the area of paediatrics with her research, writings and interaction with other health care providers and non-chiropractic academia on the efficacy of chiropractic for children and pregnant women. She is one of the founding leaders of the ICA Council on Chiropractic Paediatrics.”
November 29th, 2011 at 8:51 pm
Most of you have failed to accept her outstanding work and recent progress and recognition in the biotech field, further more speaking at many noteable medical venues. I can best describe your comments as sour grapes, she is onto something that is beyond your capacity.
December 6th, 2011 at 11:49 am
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February 2nd, 2012 at 10:02 pm
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