Corrigendum. The Week in Review. 03/26/2017
1 hour ago
Adina,Your method of debate is a refreshing change from the usual vitriol. Thank you.I have a couple of initial questions I'll get out of the way first:
“1) Do have experience in statistical analysis or epidemiology?”
Did you read the details or any critical reviews of the epidemiology you broadly reference?”
(Parenthetically the third world application of Rota vaccine is relevant but so is the fact that it is currently recommended as a childhood vaccine in the US. The US recommendation is justified as a reduction in cost due to reduced hospitalization, not death. This is far more relevant to your readers when considering the risks.)
"However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.)"
In order to support the notion that the claims of damage have been vaccinated, you would have to produce case studies or at least detailed follow-up for the affected group OR at least you have to illustrate that enough study of children with similar risk profiles were studied en masse. Neither you or Dr. Offit have provided them so right off the bat, the definitive statement that the topic has been studied is not justified in my opinion. In general, you will find that in the cases of vaccine damage very little documentation is available and there certainly is no large cumulative study of affected children. That alone should raise red flags in a system that mandates a medical intervention.
It shouldn't be a surprise that Hannah Poling's case was actually investigated in detail likely only because her father was a neurologist with both the power and wherewithal to ensure her case was studied in detail"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" “
I might have missed it, but I don't see anywhere they state that the decisions are not based on scientific evidence. Medical records and expert assessment were provided in this case, and certainly expert assessment qualifies as scientific evidence. Your definitive statement here is not justified.”
"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 Poling case was conceded after a review by the HHS scientists. It never went to a hearing before the Special Masters. The HHS scientists examined the scientific evidence presented and determined that a hearing was not required, as they concluded the act of vaccination contributed to her brain damage (encephalitus) leading ultimately to a diagnosis of Autism. Your own statements don't match the facts and display the bias of Dr. Offit's opinion pieces (where it is difficult to evaluate the level of bias).
You seem to make more factual errors about the case of Andrew Wakefield: "Many of Wakefield's co-writers testified in court that he had falsified data, and 10/13 authors retracted their 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.""I am interested in which trial of Dr. Wakefield anyone testified that data was falsified? I suspect you're incorrectly referring to the Omnibus hearing (which you yourself stated was unscientific) which did not involve Dr. Wakefield at all. Allegations against him were made despite the fact he was not a participant in the hearing, and thus he had no opportunity to rebutt the accusations. It would be good for you to clear up this allegation of yours, because as it stands, your statement does not match the facts that I am aware of. Given the diligence of most of your post, you seem to be making quite a few errors around the legal and personal aspects. I can only assume that you have been swayed by the many biased writings of these events without actually understanding the details of the events that unfolded. Wakefield is currently undergoing a GMC fitness hearing in the UK but no transcripts have been published and no verdict delivered so your conclusions appear a bit premature.
You also make two further misleading statements: First, your wording infers that the retraction was significant despite the fact they only retracted the interpretation not for scientific reasons, but public relational ones as they noted in the section of their statement that you ommited. Second, you infer that the lack of a causal finding between MMR and autism was a new revelation, when it was already explicitly stated in the original paper (discussion section page 641). Your selective quoting makes a big deal out of very little just like the misleading press releases on the topic.
"However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.)"
Going back to this quote, I want to continue driving into the studies you reference through Dr. Offit. First, I'm surprised at your use of such a definitive statement (doesn't cause autism) that really can't be supported by any scientific studies of epidemiology. The conclusion that doesn't cause Autism isn't even that interesting really. We want to know if it contributes to damage including autism (or other problems). The case of Hannah Poling is a great illustration that vaccination alone did not cause the damage, but it certainly appears to have triggered and exacerbated it.
This is particularly pertinent with Thimerosal and this leads to my original questions at the top. If you read the details of these studies, you'll find that the two founding components are data on the prevalence of Autism and the estimated cumulative exposure of Thimerosal during infancy. I hope you've read critical reviews of the studies quoted by Offit, and the data they're based on. If you aren't aware, there is wide disagreement on the reliability of the Prevalence data, and there are significant known issues with the Danish Registry, the UK's GPRD, and the US databases over the period of time studied. I recommend at least finding and reading some of the statistical arguments against the use of prevalance numbers in these studies. As you should know, the role (and bias') of the statistician is critical in influencing the outcome because numerous assumptions and adjustments must be made in these studies which are already subject to a high risk of false positives and negatives. When working with difficult, inconsistent, or incomplete data (sometimes withheld from independent public analysis) the knowledge of conflict of interest is quite important.
The other issue is that these studies only look at the cumulative exposure over a long period of time. We know that the timing toxic exposure to virus' (CRS is a great example) or toxins in fetus' or infants can be quite significant in determine the outcome of damage. We also know that very low levels of heavy metal exposure can also have a significant effect neurological outcomes (ex. lead: http://www.ehponline.org/docs/2005/7688/abstract.html). None of these factors are even remotely considered in these studies, yet you and others including Offit make definitive statements like "doesn't cause Autism". They only studied cumulative dose to be the defining factor, an assumption that does not hold up all the time on it's own. Another aspect that is often ignored (and Contrary to Dr. Offit's published opinion in peer-reviewed journals) the concomitant application of vaccines (MMR and Thimerosal containing) are not actually required study for pre-regulatory approval and generally remain unstudied from a safety perspective. (http://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf)
From my perspective that type of language is unsubstantiated by the reality of the limitations of the studies. The fact that Dr. Offit regularly makes public statements of this type (in addition with factual error that require correction) significantly hurts his credibility and I argue exposes his bias. Overstating the conclusions of scientific study, especially ones based on weak data is a reccuring issue. As for MMR, I suggest you read the Cochrane systematic review of MMR studies from 2005/2006: http://www.cochrane.org/reviews/en/ab004407.html.
After reviewing an extensive list of "definitive" MMR studies performed over several decades, they concluded that the study of both efficacy and safety was inadequate. If you read the details, (I suspect you'll find several of Dr. Offit's references in there) you'll see findings of serious methodological issues with seemingly "credible" study also heralded historically by regulatory bodies as "definitive". From this perspective you might understand why I remain skeptical of definitive claims issued by the likes of Dr. Offit.
Overall, I think there is plenty of justification of continued study. None of these studies you referenced ever examined the long term effects of either MMR or Thimerosal exposure in any RCTs (or as close as we can get given ethical limitations). We know from recent history (HRT being a prime example) that large long term studies often reveal unexpected negative outcomes in treatments assumed and shown to be safe by previous regulatory studies.
"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)."
This is an interesting opinion which I would like to examine outside of the vaccine discussion. Expert opinion still plays a role in evidence based medicine (which is what I assume you meant when using the term "science based medicine"). Cumulative clinical experience forms the heart of expertise. I am concerned that you also dismiss the value of clinical experience in detecting problems. It is exactly the detection of patterns of anecdote that usually lead to further study of issues. The other important factor is that repeated follow-up into similar individual cases may reveal biological mechanisms which can (and should) also be used to form a hypothesis. The fact that disease reporting is mandated by law, yet pharmaceutical adverse event follow-up outside of research settings is voluntary are rife with error is a sad reflection on our priorities in my opinion.
Again, thank you for bringing a refreshingly politeness to the discussion. I wish you success in your studies. My only suggestion is to drill into the details of the assumptions underlying the evidence you use to justify closing the door on further research. Given the significant challenges facing our newer generation of doctors, I think you should drill into the well documented issues (plenty of peer review studies on this topic) with industry funded peer-review studies, and into the details of the impact that bias can have on statistical analysis. You might find (like I did) that the conclusions you're quoting are based on a lot more assumptions and questionable source data than you would like. (the latter not the fault of the authors, but on the lack of interest/diligence by medical regulatory authorities).
Potential Bias: I have two healthy NT children, one partially vaccinated (older), one unvaccinated (younger)
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.
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 mothering2."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.
-He is a vaccine patent holder who won't say exactly how many millions he made from RotaTeq, but says it was like "winning the lottery".
-He was reprimanded by Congress for his ethical breaches and conflicts of interest when as a member of the ACIP failed to abstain, but rather voted to put RotaShield on the CDC schedule, effectively creating a market for his own vaccine by insuring that it would go directly into doctors offices nationally the day after it was approved.
-RotaTeq is arguably the least important vaccine on the schedule for children to receive as Rota virus represents a minimal health threat to American children. (CDC's web site recommends that it be treated with rest and Pedialite). If Jenny's message that kids are getting "Too Many, Too Soon" is taken seriously and adopted, and the vaccine schedule is paired down, certainly RotaTeq will be the first to go as it has been confirmed that it causes Kawasaki's disease and fatal Intussusception.
-He has been publicly and repeatedly corrected for spreading misinformation and inaccurate statements about the cases in the vaccine injury compensation program, most notably this past year in both the Wall Street Journal and the NEMJ.
-He is currently being sued for libel by at least one person he wrote about in the book.
-Although he is quoted at least weekly claiming that vaccines have no relationship to autism, he almost never discloses that he is a vaccine patent holder and has major conflicts of interest. CBS News even did a piece on his failure to disclose (Along with AAP and Every Child By Two. And it turns out Amanda Peet is even being paid by Wyeth for her vaccine promotional spots).
-He routinely makes outlandish and irresponsible remarks such as his famous, "theoretically a baby can receive 100,000 vaccines at once safely" absurdity (I wrote to him the first time I saw this in print and was sure it was a misquote, and asked for a corrected quote from him. He replied that it was a correct quote and "that is probably a conservative number".)
(To be frank, we can't under stand why anyone takes him seriously, and suspect that it is his mere bravado that has prevented people from cluing in to the fact that he is not responsible physician.)
So given all the potential for bias here, don't you think that it might be wise to take a hard look at the other side and make sure that the information he is giving you is reliable and complete?
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.
The plural of anecdote might not be data, but is a hell of a clue that any honest, earnest, evidence based loving clinician would be remiss not to examine, to put it politely. Criminal might be a better characterization.
"her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic."
So ask yourself, if Offit and CDC and AAP and the vaccine industry are so keen on insuring vaccines don't cause autism, and why have then not take Evan and those 1,100 kids, put them in a long list and compare them to patients of a similar demographic? (Why is there no study comparing kids with an autism diagnosis who undergo biomed with those who don't to see how functional they are at age 10 or so?) Jenny has repeatedly called CDC and asked them to examine her son and all the kids like her son, yet they have never contacted her or ARI or any of the parents who have before and after videos all over the internet showing their recovery stories.
Does that lack of curiosity raise any red flags for you?
Do you think that if one medical practice (much less several dozen) announced they had 1,100 cases of people who recovered from HIV/AIDS, all with evaluations, test results, medical records and videos to prove it, that CDC et all would collectively yawn, quote Brinner, claim it is not data and never even pick up the phone to see if an actual cure had been found? Even for just some cases of HIV/AIDS?
Not in a million years.
(...and if that ever happened, San Francisco would burned to the ground by protesters).
So why is it that with all the claims of vaccine regression and subsequent recovery, are you satisfied with the "no association, no know cause or cure" line from the very people, Offit, HHS, CDC, AAP et al, who would be held responsible and be out of their collective posteriors for causing the autism epidemic if it turned did out to be the vaccines?
Especially when they are not showing up in our community to evaluate our claims and examine our kids?
Especially when they are doing everything possible to prevent REAL vaccine research from being done. Like just three days ago when the Federal members of the IACC voting NOT to study vaccine causation" with the funding from the Combating Autism Act (in opposition to the community members, autism parents, who wanted the research done), one of the regional intents of which was to study the possible association between vaccines and autism.
Ask yourself, why won't health authorities do a simple study comparing vaccinated and unvaccinated children, to look for overall health out comes and see if kids vaccinated according to the CDC schedule have more autism, ADD, asthma, diabetes, arthritus and other neurological and immune disorders?
Why does a Congresswoman have to propose a bill to force NIH to do the study? Shouldn't they want to do it? Certainly there are more and more unvaccinated kids out there to study, and if in fact Offits claim that there is absolutely no association is true, then it can only improve vaccination rates to put a study out that can make the claim with authority.
And why... when no such study exists, can anyone make the claim that vaccines don't cause autism? Vaccines as a whole have never been studied, merely a few different aspects of the vaccine program. And they have been studied quite poorly in many cases.
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.
You owe it to your future patients to have actually teased out the truth on this for yourself rather than just swallowing what those who quite obviously and transparently protecting professions and individual careers tell you the truth is.
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 expensively22.”
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).
Bottom line, if you don't look all sides on this and make your own decision (rather than just joining the Orac insult-o-rama), then you risk taking on their crime of injuring children and withholding needed treatment if 'my side' is right.
I urge you, while you are still very early in your career, to take this subject very seriously and listen to autism parents and see if their concerns, questions and challenges are actually being answered by those you are taking your advice from currently. Are they really dealing with them, or just setting up straw men and knocking them down?
I (and many other parents) would be happy to talk to you about what we have learned and experienced and why we believe as we do, should you earnestly want to investigate autism causes and treatments on your own.
"My science is Evan, and he's at home. That's my science." [Loud, thunderous applause].
"We presented a new idea on how to treat autism and how to treat mercury poisoning, because these kids aren't autistic, they're mercury poisoned. Although I'm not happy with trying it on children without further research, these people are desperate and there have been some remarkable responses."
Physicians have to be paid well in order to continue to practice medicine. It wasn’t always this way. Because, there was a time in modern medicine when the rewards of the practice of medicine were considered higher than mere cash. Why did early physicians expose themselves to epidemics and death? Why did they go to battlefields and learn surgery? Why did they labor with the miserable and poor? Because they sensed the value of human-kind. They were taught, and believed, that every life was valuable in God’s eyes, and that if they ignored their calling, and ignored suffering, they would face God’s wrath. They also believed that if they did right, if they endured under hardship, if they died of the diseases they fought against, they would be rewarded by their Creator.
We are too modern for all that, now, aren’t we? We don’t need mumbo-jumbo, irrational, anti-scientific theories about human worth. We’re post-moderns! We will do right, because it’s good for mankind and good for society and because our reward will be…well, it will be science and knowledge…I mean, it will be the survival of all the fittest for the collective good of mankind in a few eons…it will be…a good review from my boss and a nice retirement with a boat…it will be a vacation and a car and….well, some money will do nicely, if you please.
Reject transcendence if you will. But if you do, prepare large boxes of cash. Because doctors without a sense of temporal and eternal purpose will have to be rewarded financially in order to stay in a long, arduous educational system, in order to work all hours, in order to expose themselves to risks physical, emotional and legal and in order to come back day after day to a job that is sometimes amazing but often quite tedious and frequently quite maddening.