Ginger Taylor, the parent of a six-year-old son with autism, wrote a lengthy response to my previous post, "The Disappointment of Hearing 'Your Results Don't Matter.'" Ms. Taylor sounds like a woman who is truly dedicated to her son's successful development. However, I still find a number of Ms. Taylor's contentions to be unfounded. I am responding to her comments, albeit with a bit of hesitation. I am not an expert on the subject of autism, and do not wish to misrepresent the scientific community. If there are any mistakes, they are solely my own. Here goes:
You seem to have made an assumption here, that certainly would be a reasonable one if Paul Offit and his compadres are your main source of information on biomedical intervention for autism. And that seems to be that just because Jenny McCarthy didn't present the kind of evidence you are looking for to prove the efficacy of the treatments she used when she was on Oprah, and just because Offit says there is none, that they don't exist.
Perhaps it's true that there is better evidence than that which Jenny McCarthy presents("My science is Evan, and he's at home. That's my science 1"
I am the mother of a 6 year old that regressed into autism following his 18 month vaccinations and have gotten him about halfway back with the evidence based interventions that Offit has derided.How do you know that you haven't gotten him "back" (I assume you don't mean "cured") simply due to good parenting? Effective behavior modification techniques? A good social environment? There is no way to know if your child improved due to any specific intervention. Don't sell yourself so short. I'm sure that your son's success has a lot more to do with the time and devotion you dedicate to him than to anything that anybody's selling you. There is a long history of blaming autism on "bad mothering 2."Parents should feel pride in their children's progress, rather than (unfounded) guilt due to a feeling that they've exposed their children to something harmful.
Offit is not a good source on autism treatment (he does not even treat children with autism, he is an infectious disease specialist), and his vast conflicts of interest should be raising huge red flags for you.
Perhaps Offit is a mean, greedy man, who enjoys slandering people, and who is simply trying to make more money from his Rotavirus vaccine. I don't know him personally, so I have no specific objections to these claims. The problem is, I don't care about Offit's personality or accomplishments or lack thereof. My only concern is whether or not the statements about autism that he states in his book are factual. Luckily, if I'm suspicious about potential conflicts of interest, I can investigate all of his claims independently, as Offit has provided 32 1/2 exhaustive pages of footnotes in his book, all of which refer me to all of the relevant papers and transcripts. If you can show me a place in his book where Offit
1) Falsifies information from these references AND
2) Such falsification is so damning that it undercuts his basic argument (i.e. invalidates the heap of evidence that he provides in the other 246 pages in his book),
then I would certainly take this objection seriously. But none of the arguments presented above satisfy either of those conditions, as they only address why Offit might want to falsify information, not whether or not he actually did so.
(Parenthetically, please know that intussusception occursspontaneouslyin approximately 1 out of 2,000 healthy young infants and children per year. The fact that Rotateq may cause intussusception (bowel obstruction) in 1 out of 12,000 patients must be weighed against the fact that the vaccine is generally administered in developing countries, where approximately 475,000–580,000 childrendiefrom rotavirus infection each year, according to the WHO. All treatments (and human actions) have costs. You must compare these costs to the corresponding benefits).
Because it is not like you have just one mom, Jenny McCarthy, standing up in public and claiming that she recovered her son from autism using these methods, the same year that her book came out, 2007, the Autism Research Institute documented more than 1,100 cases of kids loosing their autism diagnosis following biomed.
Unfortunately, the studies propagated by the Autism Research Institute do not nearly satisfy the conditions of evidence based medicine. Let's look at one oft-cited ARI-sponsored article: "Effect of pioglitazone treatment on behavioral symptoms in autistic children 4" in Journal of Neuroinflammation, written with co-contributors Stephen Edelson and James Adams of ARI.
Even after a cursory reading of this article, I find that the study included only 25 children, with no indication about whether the research subjects were recruited randomly or from a population that already subscribes to the researchers' theories. Most importantly, the study featured no control group. Scientific Method 101 says that you can't test a hypothesis without having a control. P values were not reported, so there is no way of determining whether the findings were statistically significant or simply occurred due to random chance. In fact, the authors themselves only conclude only that there should be "further testing," a viewpoint that they presumably shared even before writing the article.
Some people outright deny that the scientific method is a meaningful means of testing alternative medicine. In certain ways, I find the "research" of the ARI to be more pernicious. Their work has the cloak of science, and would seem quite convincing to someone who has no background in basic study design. I probably just prefer the people who outright claim that the scientific method is irrelevant, because at least they're being honest about their beliefs.
I know that you believe that it is "criminal" not to further investigate the claims of people who believe in the vaccine/autism link, because of the shear number of complainants. However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.) 5 More importantly, even if there hadn't been so many studies, I reject the notion that "any honest, earnest, evidence based loving clinician would be remiss not to examine" this issue, simply because many people believe in it. I will not "investigate" the claims of HIV denialists. Mass hysteria is a common historical phenomenon. If you are interested in reading an account of hundreds of people who were (erroneously) so convinced that they had been infected by a virus, that they actually began to experiencesymptoms of nausea and vomiting, please refer to Desenclos, J.C., Gardner, H., & Horan, M. (1992). "Mass Sociogenic Illness in a Youth Center." Revue D'EpidemiologieetdeSant, Publique, 40, 201-208.
Even if i had not reviewed some of the relevant literature, one hint to me that these vaccination claims are baseless would be the fact that the proposed pathophysiology constantly changes, while the culprit remains the same. Originally, it was proposed that the virulence of MMR stems from an infection caused by harmful proteins from the attenuated measles virus that reach the brain 6. Others then said that MMR induced autism via an "autoimmune phenomenon 7." Then others started to relate autism to thimerosal, saying it was due to mercury neurotoxicity, or perhaps thimerosal's binding to testosterone, which leads to hyperandrogenism8. Today, many activists acknowledge (or at least don't deny) that the vaccines are generally safe, but say that they just should not be administered to kids below a certain age, or that too many vaccines should not be administered during a short period of time (i.e. "Too Many, Too Soon"). The proposed mechanism and subsequent recommendations constantly shift and adapt with new evidence, but never actually disappear.
"her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic."
I do not know why you believe the vaccination-autism claim has not been and is not being investigated. The NIH currently hasfourstudies being performed on the subject, in addition to the many studies that already have been performed in a number of different countries. Many thousands of records have been analyzed, with every study concluding that there is no link between autism and MMR or autism and thimerosal. Japan, when it discontinued the use of MMR, did not see any subsequent decrease incidence of autism diagnoses. 9 Additional studies might be initiated when the six “Centers for Excellence in Autism Research" are created with money from the Children's Health Act of 2000. Millions and millions of dollars have been and will be spent to investigate this unfounded assertion. This money could be better spent on studies that would investigate credible "leads" about the causes of autism (such as the excellent work of the Autism Genome Project). 10
If you feel that these studies are still insufficient, all I can say is that there is only so much money we can use to chase after every proposed claim. If we performed studies to investigate each person's purported "cancer cure," we'd be left with non-useful confirmations of what we already know (i.e. that virtually all of these claims are bunk). Such studies have enormous opportunity costs, as they take away potential funding from plausible hypotheses that stem from prior research and well-reasoned pathophysiological mechanisms, rather than from conjecture. For example, it is a waste of money to study whether or not diluted duck liver cures the flu, (as homeopaths contend) 11. At least eating duck liver is harmless. Non-vaccination has led to numerous preventable deaths in developed countries in the 21st century.
I erred when I said, "her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic," because I implied that it would make sense to now add Evan's case to a scientific study. A good study would be double-blind randomized, controlled, trial including a random sample of kids with autism, rather than a cherry-picked selection of kids whose parents oppose vaccines, or whose parents who have already used alternative "treatments." Certain information can be obtained from a cohort study (a study where random children with certain conditions who have or have not had certain exposures are simply "followed" to determine outcomes), but these more necessarily require repeated investigation others, as they introduce a greater number of potential sources of error than randomized control trials.
Numerous randomized controlled trials have been conducted on kids with autism to test "natural," "biological" materials. These include the gluten-free casein-free “special diet" (which has only shown to cause bone density loss), 12 ” dimethylglycine13, and (hot off the presses, published just last week!) human immunoglobulin therapy 14. Needless to say, none of these treatments have proven to be effective. An NIH-sponsored study is underway to study the effects of cod liver oil, Vitamin B6, and Magnesium on kids with autism 15 (These vitamins are currently repackaged and sold -with a trumped up price- as "Super Nu Thera," to parents of autistic children).
You assert that the testimony of thousands of parents satisfied with " biomed" treatment should be more discomfiting to clinicians. However, thousands of parents swore by "facilitated communication," as well as by secretin, and those thousands of parents were proven to have been influenced by the placebo effect (I am not blaming parents. Nearly everyone, including myself, are at least somewhat influenced by the placebo effect). At least 15 studies were performed to test secretin therapy, a treatment once heavily promoted by the Autism Research Institute. 16 All randomized controlled trials demonstrated that the hormone caused no improvement in autism symptoms, in comparison to the placebo.
Some studies simply cannot be performed, because the proposed intervention is already known to be potentially lethal. For example, chelation therapy can be dangerous, even for someone in an acute condition who is already known to be suffering from heavy metal poisoning. When used on healthy children with autism, who have no measurable increase of "heavy metal toxicity," we put children at risk for the fate of Abubakar Tariq Nadama. Indeed, the NIHextensively plannedto perform a randomized controlled trial of chelation therapy, and called it off only when the initial animal testing demonstrated that the treatment caused extensive brain damage in rats.
As for the challenge of how we can "make the claim that vaccines don't cause autism?," my answer is we cannot make this claim, just as no one can make any claim with 100% certainty. We use science-based medicine to diminish our levels of uncertainty, until they become extraordinarily low. The fact that we can not, in any study, conclude that the "null hypothesis (in this case, that vaccines don't cause autism) is accepted," does not mean that it makes any sense to favor the alternative hypothesis (i.e. that vaccines do cause autism). For example, let's say someone made a claim that "Xenu...was the dictator of the "Galactic Confederacy" who, 75 million years ago, brought billions of his people to Earth in DC-8-like spacecraft, stacked them around volcanoes and killed them using hydrogen bombs 17." My null hypothesis would be that this event didn't happen. However, I can never affirm this null hypothesis with 100% certainty, just as I can never state "vaccination doesn't cause autism" with 100% certainty.
So... at the conclusion of my long winded comment, I would like to call your attention to Bryan Jepson's book, "Changing the Course of Autism: A Scientific Approach to Parents and Physicians". I would like to encourage you to read it and then look back at Offit's book and see if he actually is taking apart the case for biomedical research or just going after the easy targets like McCarthy, while ignoring the actual biomedical approach to autism and the science to back it up.
Upon your recommendation, I read parts of Jepson's book. To buttress his arguments, Jepson heavily cites the work of Dr. Andrew Wakefield. Many of Wakefield's co-writers testified in court [CORRECTION 1.29.09: It was not a court trial but an omnibous proceeding for the Vaccine Injury Compensation Program, for which Wakefield was not on trial. I confused this with the British General Medical Council, which is holding a hearing to examine charges of professional misconduct] that he had falsified data, and 10/13 authorsretractedtheir names from portions of Wakefield's most significant study, stating "We wish to make it clear that in this paper no causal link was established between the MMR vaccine and autism, as the data were insufficient." One witness at Wakefield's trial, Nicholas Chadwick, was the research assistant who had actually carried out the tests for the Wakefield's 1998 Lancet paper. He testified in court that, despite the fact that he informed Dr. Wakefield of the negative PCR test results, Dr. Wakefield reported positive findings in his paper. 18 There were a number of such testimonies, despite the fact that Wakefield gave $30,000-$180,000 to expert witnesses who testified on his behalf 19.
(Parenthetically, Wakefield is also under investigation for subjecting children to unnecessary and risky tests, such as lumbar punctures and colon biopsies, which would be inappropriate for any study, so long as these procedures were not medically indicated. An associate affiliated with the study ended up perforating a child's colon in a number of places. 20 Some of the actions that Mr. Wakefield is accused of performing, such as handing out cash to children who attended his son's birthday party, and then collecting their blood as samples, are downright bizarre. He failed to use a random sample of children in his studies, using mostly clients of a trial lawyer, Richard Barr, from whom Wakefield had received, on his own admission, at least $50,000 21 ).
In other words, I do not find Jepson's book, which heavily references Wakefield's papers (as well as the work of the Geiers, who also performed poor research), to be particularly reliable.
You clearly, clearly want to make the right decisions for your patients. What if the right decision for some of your patients was not to vaccinate them according to the current CDC schedule (clearly it was the wrong decision for Hannah Poling, Madison Hiatt and the thousands of others who have received a billion of dollars from the Vaccine Injury Compensation Fund)? And the right decision for some of your patients with ASD was exactly what Jenny McCarthy did for her son? And what if you never looked into it because Offit etc told you not to bother?In terms of the Vaccine Court, the fact that those girls got money from the Vaccine Compensation Fund is not particularly relevant, because the cases are not judged based on scientific evidence. A team of lawyers (called "special masters") with no medical background, rather than a judge, jury, scientists, or medical professionals, preside over the cases. The court's guidelines state that “special masters are not bound by formal rules of evidence” and that both sides should “be creative” in presenting their arguments “quickly and less expensively 22.”
The court had no way of verifying whether or not Hannah Poling's autism (caused by an underlying mitochondrial disorder) was indeed aggravated by vaccination. Even Poling's doctor, John Shoffner, an expert in mitochondrial disease, was"genuinely puzzled"by the verdict. As far as I'm concerned, the findings of this court have little to do with science.
As I wrote on my other post, learning about the experiences of my patients and their families will be crucial for my providing good care, but is not relevant to science-based medicine (excepting in the use of case studies, which have limited value, and which are generally only used to develop hypotheses).
I know that "look at all sides on this" sounds neutral and unbiased, and that I should not "risk taking on their crime of injuring children and withholding needed treatment if 'my side' is right." The problem is that I am confident that I would cause more harm if I spent time to "look at all sides on this" and continued to pore over everyone's counterpoint for these debunked claims. I can spend a lot of time investigating whether or not HAART causes AIDS, or whether oleander defeats cancer, and any other medical claim ever proposed. Nobody can independently investigate every contention. However, doing so would detract from learning to read EKGs or chest X-rays, or performing other tasks that are crucial to avoiding future medical errors and providing excellent patient care.
Every one needs a gestalt about which resources to trust, and on what basis to accept information. A method may occasionally fail, but one chooses it because, compared to all other strategies for acquring information, it provides the greatest accuracy for the most important issues, with the greatest efficiency. To me, trusting a random website would be quick, but unreliable. Doing my own experiments on every issue might be reliable, but extremely inefficient. The best method available for clinicians to acquire scientific information is to use books and journals edited by people whom we know subscribe to a similar epistemoligical approach (i.e. commitment to the scientific method), and whom we know are held accountable for their claims, by the scrutiny of peer review. Will people sometimes falsify data or make errors? Yes. However, after a while, repeatability of experiments stops bad or mistaken research in its tracks.
I figure you might think that this is just a battle of "my favorite studies" versus "your favorite studies," and that the abundance of conflicting papers means that we can't know who is correct (which would theoretically render scientific research to be quite useless, on the whole). While controversy and uneven results can indeed be frustrating, I must say that this isn't a matter of my preferentially selecting studies that would help my case. The scientific method requires "appropriate design and analytic methods...critical to achieve meaningful results." Such methods include "definition of exposures and outcomes, validation of developmental diagnoses, provision of sample size calculations and/or discussion of study power, and statistical methods including techniques to control for potential confounding." One study compared a number of epidemiological cohort studies that investigated a possible vaccination-autism correlation, and found that only the study by the Geiers, (which was also the only study that reported a correlation between vaccination and autism) fulfilled zero out of eight epidemiological criteria. There are a lot of seductive "studies," that we may hope to rely upon, but we can still distinguish the good from the bad, especially with the power of repeatability.
Good luck, Ms. Taylor, and I hope your son's development continues to be successful. I have a family member with an autism-spectrum disorder, and I have observed firsthand the amazing dedication and love that parents put in to careing for these wonderful kids.
1. Jenny McCarthy on Oprah. Interview by Oprah Winfrey, Oprah Winfrey Show, NBC, September 18, 2007. Source from Offit, Paul A. Autism's False Prophets (Columbia: New York, 2008).
2. Bettelheim, Bernard. The Empty Fortress: Infantile Autism and the Birth of the Self (New York: Free Press, 1972). Source from Offit.
3. Offit. 110-111.
4. Boris, Martin and Claudia C. Kaiser, et. al. "Effect of pioglitazone treatment on behavioral symptoms in autistic children." Journal of Neuroinflammation 2007, 4:3.http://www.jneuroinflammation.com/content/4/1/3
5. Please see the pages-long list of studies in Offit 256-7 and 266-7.
6. Letter from Dr. Wakefield to journalist Brian Deer. 12.2.04.http://briandeer.com/mmr/wakefield-st-statement.htm
7. Waisbren, Burton A. "It is time to face up to the problems of MMR vaccination and its possible relationship to Autism."http://www.waisbrenclinic.com/mmr-autism.html
8. Geier, David A. and Mark R. Geier. "The Biochemical Basis and Treatment of Autism: Interactions between 3 Mercury, Transsulfuration, and Androgens." Autoimmunity Reviews. Retracted by publisher before publication. Available athttp://briandeer.com/wakefield/geier-mark.pdf
9. Honda, Hideo and Yasuo Shimizu. "No effect of MMR withdrawal on the incidence of autism: a total population study" Journal of Child Psychology and Psychiatry. 46:6. 572-579.http://www3.interscience.wiley.com/cgi-bin/fulltext/118735419/HTMLSTARTSource from Offit.
10. The Autism Genome Project (AGP) Consortium. "Mapping autism risk loci using genetic linkage and chromosomal rearrangements." Nature Genetics. Published online: 18 February 2007, doi:10.1038/ng1985.
11. Vickers AJ, Smith C. "Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes.", Cochrane Database Syst Rev. 2006, Issue 3. Art. No.: CD001957.
12. "Autism in Celiac Disease: Failure to Validate the Hypothesis that a Link Might Exist." Biological Psychiatry. 42(1997):72-75. See other sources in Offit 270.
13. 5. Bolman, William N., John A Richmond. "A Double-Blind, Placebo-Controlled, Crossover Pilot Trial of Low Dose Dimethylglycine in Patients with Autistic Disorder," Journal of Autism and Developmental Disorders 29:3 (1999) 191-194
14. 7. Handen, Benjamin L. and Raun D. Melmed. "A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder," Journal of Autism and Developmental Disorders
DOI 10.1007/s10803-008-0687-y. http://www.springerlink.com/content/r741394286415x84/
15. "Treating Oxidative Stress and the Metabolic Pathology of Autism" Arkansas Children's Hospital Research Institute. ClinicalTrials.gov Identifier: NCT00572741.
In recruitment stage.
16. A.D. Sandler, K.A. Sutton, et. al. "Lack of Benefit of a Single Dose of Synthetic Human Secretin in the Treatment of Autism and Pervasive Developmental Disorder," New England Journal of Medicine 341 (1999):1801-6. See other studies mentioned in Offit 251-2.
17. Wikipedia article on the Scientology figure, "Xenu."http://en.wikipedia.org/wiki/Xenu
18. United States Court of Federal Claims. Docket Number 98-916Vftp://autism.uscfc.uscourts.gov/autism/transcripts/day10.pdf
19. Full Legal Services Commission Report obtained by Brian Deer via Freedom of Information Act. Available athttp://briandeer.com/wakefield/legal-aid.htm
20. R. Ellis, "₤500,000 Payout for Autistic Boy Left Fighting for Life After Being Used as an MMR Guinea Pig." Daily Mail. December 8, 2007. Source from Offit.
21. MP3 audio available athttp://briandeer.com/mmr/wakefield-archive.htmand sources cited in Offit page 258.
22. "Guidlines for Practice Under the National Vaccine Injury Compensation Fund." The Office of Special Masters. United States Court of Federal Claims. Available athttp://www.docstoc.com/docs/831292/Guidelines-for-Practice-Under-the-National-VaSource obtained from Grant, Andrew. "Inside the 'Vaccine Court.'" Scienceline.http://scienceline.org/2008/07/25/policy-grant-autismvaccinecourt/