Dear Mr. Lowes:
Thank you for your article titled "Anti-Vaccine Proponents Claim Court Paid for Autism Cases" published at http://www.medscape.com/viewarticle/742471 on May 10, 2011. I am a coauthor of the paper that was published on May 10, 2011 in the Pace Environmental Law Review. I am writing on behalf of the authors.
As one of my coauthors may already have communicated to you, we take exception to the title of your piece, with specific reference to your use of the word "anti-vaccine." There is no statement in our paper that communicates any "anti-vaccine" view, whatsoever. Public statements made by the authors and some parents who were included in the case analysis contained in the paper have never evidenced an "anti-vaccine" view. To the contrary, many of the participants have clearly stated their support for vaccines and the government program that promotes vaccination.
Would you characterize citizens who bring to light automobile defects, such as the recent reports about brake failure in certain automobiles, as "anti-automobile"? I am sure not. Nor would you criticize airline safety critics as anti-airplane, nor even critics of certain drugs like, for instance, Vioxx, as "anti-drug."
Our focus in the paper is the history and functioning of the legal process. We have pursued a serious consideration of whether the purposes of the National Childhood Vaccine Injury Act are being realized and whether justice is being achieved for aggrieved families and children. This focus, while undoubtedly inviting controversy in itself, is distinct from the vitriolic and sometimes ill-conceived debate that induces some to invoke rhetoric that utilizes the words "anti-vaccine" and other empty slogans.
Since there is absolutely no basis to justify the use of the characterization "anti-vaccine" in your news report we respectfully request a retraction and clarification.
Other areas of your report require attention.
Our paper does not report that "roughly 3% of vaccine injuries …involve brain damage that included autism." This statement is contained in some news and other statements made separately from the paper and is based on an extrapolation of the fact that we found 83 such cases. 83 cases computes to slightly more than 3% of the approximate total number of compensated cases, which is approximately 2500. We deliberately avoided any such statistical conclusions in the paper because our research is preliminary and constituted review by interview and verification of only 150 cases. While extrapolation allowing use of the 3% computation is tempting and would allow the statement that 41% of reviewed cases showed "autism", we deliberately avoided making this statement, as our analysis is not an epidemiological or statistical one. It is a case review of a small percentage of the cases compensated in the Vaccine Injury Compensation Program. Thus,while it is fair to state that to this point we found cases showing "autism"that would constitute 3% of the compensated cases, this statement can be misleading. In fact, we believe – but this is not much more than conjecture at this point – that the total number of compensated cases also exhibiting autism is substantially greater than 3% of the total number of compensated cases.
We do believe that what we found – including the number of cases of"autism" that we found – is significant, and justifies further investigation of all the compensated cases.
In addition, your article reports, "[t]he study authors looked at roughly 2500 claims of vaccine injury as of October 2010 that were compensated by the VICP since the program’s inception." This statement is incorrect. We conducted interviews and follow-up verification of 150 cases only. We also surveyed the small number of compensated cases that were the subject of published cases decisions. Thus, we have reviewed in some form thus far a small fraction of the compensated cases – something less than 15% to 20% at most.
We think it may mislead readers to suggest that we reviewed all 2500 compensated cases when, in fact, we only reviewed a small fraction of those cases. We are calling for a complete review and investigation of all compensated cases to determine the medical status of individuals injured by vaccines. This type of investigation is what Congress envisioned when it enacted the National Childhood Vaccine Injury Act of 1986 with the following purposes: immunize the vaccine industry to ensure vaccine supply, enhance vaccine safety, and provide for those individuals who will, inevitably, be injured by vaccines.
While we understand you are merely reporting his view, we believe that at least one of the statements of Paul Offit, M.D. contained in your piece merits special attention. Your article reports, "Dr. Offit said the study authors reach erroneous conclusions due to an erroneous definition of autism. A child with measles encephalopathy, he said, may have severe cognitive deficits that fall into the autism spectrum, but such symptoms themselves do not necessarily translate into a diagnosis of autism."
Dr. Offit’s statement, as reported by you, completely misconstrues the point of our paper and reveals a fundamental misunderstanding of “autism”.
Your article failed to explain, as reported in our paper, that "autism" is defined and diagnosed purely by its symptoms. A primary point of our paper was to show that by the very definition of "autism" as set forth in the DSM-IV many children compensated for vaccine injury have "autism."
Dr. Offit’s position makes little sense. He does not explain how our definition of "autism", as taken from the DSM-IV is "erroneous" nor does your piece offer the definition that Dr. Offit purports to be the correct one. Contrary to the assertion contained in your article, symptoms of autism do translate into a diagnosis of "autism." If we are to accept Dr. Offit’s claim, as reported in your article, that "such symptoms do not necessarily translate into a diagnosis of autism" the diagnostic criteria used for this disorder would be rendered variable and completely meaningless, as there are no physiological biomarkers used to diagnose the condition. By definition, symptoms of "autism" whether caused by measles encephalopathy or some other agent, constitute "autism."
An illustration of the absurdity of Dr. Offit’s claim is the example of thalidomide. It was discovered by researchers in the 1990’s that one cause of "autism" is prenatal exposure to thalidomide during a particular narrow window of time during pregnancy. Are we to diagnose children who evidence symptoms of "autism" caused by this exposure with something other than "autism" – say, "pre-natal thalidomide induced behavioral syndrome"? Perhaps, but the children so afflicted would also be diagnosed with "autism." By Dr. Offit’s logic we would not be able to say that thalidomide causes "autism." Leading researchers have concluded otherwise and their parlance has drawn acceptance from mainstream medicine.
Undoubtedly, in trying to make his point Dr. Offit was mindful of the VICP experience in the case of Hannah Poling. Hannah Poling was diagnosed with "autism" according to her pediatric neurologist and as reported in a paper published in the journal, Child Neurology. In agreeing that the petitioners merited compensation for vaccine injury, HHS officials first acknowledged that her injury manifested as a regressive encephalopathy with features of autism spectrum disorder. The officially reported decision granting her compensation described her injury, however, as post MMR encephalopathy. In a semantic tour de force, Dr. Offit and HHS officials thus have successfully avoided categorizing Hannah Poling’s injury as "autism." By doing so Offit and HHS both claim to be able to say that "vaccines don’t cause autism." But Hannah Poling indisputably was diagnosed with autism and this manifestation of injury was part of her claim.
This is precisely the kind of semantic game that we believe requires investigation. Brain injuries to children are serious and life-long. Using word play to avoid the unpleasant association between vaccine injury and "autism" is not helpful to our children and evidences an institutional mendacity that ill-serves our nation’s children.
The logical extension of Dr. Offit’s position would be the proposition that there exists no fixed definition of autism and that when vaccine injury occurs autism is necessarily excluded as a diagnostic possibility. This flies in the face of routine diagnostic procedures but does illustrate the type of diagnostic manipulation and legal decision-making that may occur to confuse the issue of whether or not "autism" and vaccine injury are linked.
While we may take issue with some other aspects of your piece that are beyond the scope of this note, we respectfully request clarification of the important points we have highlighted.
Again, we thank you for reporting about our paper. We will gladly remain available if you have any additional questions for us.
Law Office of Robert J. Krakow, P.C.
1205 Franklin Avenue, Suite LL20
Garden City, New York 11530
(212) 227-0600 (NYC)
(888) 449-8529 (fax)
(516) 359-0958 (Mobile)