"The Appalling Poling Saga" · Oct 3, 01:00 PM

The current issue of the Journal of Child Neurology (JCN) contains a remarkable trio of letters regarding Developmental Regression and Mitochondrial Dysfunction in a Child with Autism, a report by Dr. Jon S. Poling, Dr. Richard E. Frye, Dr. Andrew W. Zimmerman and Dr. John M. Shoffner which was published in that journal in February 2006.

Developmental Regression and Mitochondrial Dysfunction in a Child with Autism describes the case of an unnamed child whose health and development deteriorated after a series of ear infections and a vaccine-induced varicella (chickenpox) infection. The child was diagnosed with autism at two years of age; numerous blood tests and a muscle biopsy revealed an underlying mitochondrial dysfunction. Review and comparison of laboratory records of Kennedy Krieger Institute patients with autism and other neurological conditions yielded various abnormal metabolic markers in a portion of the autistic subjects. The authors discuss indicators and possible triggers of mitochondrial dysfunction, such as immune activation by infections or immunization, and end with a call for further research to identify reliable laboratory markers to detect mitochondrial abnormalities.

As is customary in scientific papers, the authors acknowledge limitations of their analysis, such as the possibility that their data might have been skewed by false-positive laboratory results. However, although it is also customary for authors to disclose potential conflicts of interest, the published article includes no mention of the fact that co-author Dr. Jon Poling is the father of the child described in the report, and that he, his wife and daughter are petitioners in Poling v. HHS (Case 02-1466V), a pending Vaccine Injury Compensation Program (VICP) claim involving exactly the matters described in it. (According to the U.S. Health Resources and Services Administration, the average VICP award amount totaled approximately $1 million at the time Dr. and Mrs. Poling filed their petition for compensation.)

This lapse went relatively unnoticed until February 2008, when publicist David Kirby announced the decision of the Division of Vaccine Injury Compensation (DVIC) to compensate Miss Poling for injuries possibly induced by one or more vaccinations. (Although DVIC issued its entitlement decision in November 2007, Mr. Kirby did not publicize it until after Dr. Zimmerman and Dr. Mark Geier submitted expert reports in the case, and after the Polings’ attorney, Clifford Shoemaker, negotiated compensation for treatment of the child’s seizure disorder, which emerged when she was six years old.) In his announcement, Mr. Kirby cited “some journal articles and other articles” whose authors had speculated that “10% to 20% of all autism cases may involve mitochondrial disorders.” Developmental Regression and Mitochondrial Dysfunction in a Child with Autism was described as:

Another article published in the Journal of Child Neurology and co-authored by Dr. Zimmerman… The authors… reported on a case-study of the same autism claim conceded in Vaccine Court…

Mr. Kirby did not disclose that the lead author of the case-study was not the relatively well-known Director of Medical Research at the Kennedy Krieger Institute, but the child’s father and petitioner in the VICP claim.

A carefully-orchestrated storm of publicity ensued. In a press conference, appearances on Good Morning America, Larry King Live and Cable News Network, and interviews with USA Today, The Atlanta Journal-Constitution and other national media outlets, Dr. and Mrs. Poling, Mr. Shoemaker, Mr. Kirby, Dr. Geier, and other vaccine-injury plaintiffs’ advocates hailed the decision as a landmark with potential to affect the outcome of more than 5,000 pending VICP claims.

On February 29, Dr. Steven Novella of Yale University published a discussion of the Poling decision, answering the question, “Has the Government Conceded Vaccines Cause Autism?” with an emphatic “No.” Dr. Poling responded with a comment posted to (and since deleted from) Dr. Novella’s blog, and simultaneously published as an open letter on Age of Autism, a group blog promoting the interests of vaccine-injury plaintiffs. Although he advised that he would “not be able to respond to individual comments,” I took the liberty of asking one specific question prompted by his disclosure that he had “accepted consultancy or speakers honoraria from Pfizer, Eisai, Ortho-McNeil, Biogen, Teva, Immunex (now Amgen), and Allergan.”

You’ve declared your COI’s [conflicts of interest] in this post. Why didn’t you declare your COI’s in your article in the Journal of Child Neurology — most notably, the fact that you were father to the the subject of the case-study, and party to a pending legal claim involving precisely the issues described in it?

As promised, Dr. Poling did not reply, either on Dr. Novella’s blog or on other online forums where Developmental Regression and Mitochondrial Dysfunction in a Child with Autism was being discussed.

The matter eventually attracted the attention of the publisher of the Journal of Child Neurology, as evidenced by the publication in its September 2008 issue of a letter by Dr. Jon Poling, a second letter by co-authors Dr. Richard E. Frye, Dr. Andrew W. Zimmerman and Dr. John M. Shoffner, and a third by JCN’s Editor-in-Chief Dr. Roger A. Brumback, Professor at Creighton University School of Medicine. (Throughout October 2008, Sage Publications is offering free public access to all of its online journal content, including these three letters.)

In his letter, Dr. Poling defends the quality of the report, explains his failure to reveal his status as the father of the child described in it, and maintains that the details of her case were disclosed without his consent.

Our report was fair and accurate, adhering to the highest standards. [My daughter’s] name was withheld to protect a 6-year-old child. A third party subsequently leaked, without our knowledge or permission, my daughter’s identity and the government’s concession report to the media. In hindsight, I agree that I should have declared my daughter’s identity in a separate letter to JCN. I apologize for that omission. [emphasis added]

Defending his failure to disclose his status as a VICP petitioner, Dr. Poling cites the long delay in case processing and his minimal input, and asserts that publishers’ disclosure requirements have already impeded the free flow of “promising leads or discoveries” involving researchers’ family members.

Regarding the 2002 case filed through the U.S. Vaccine Injury Compensation Program (VICP) on behalf of my daughter, neither I nor my wife Terry included or referenced the JCN case report in any information that we submitted to the government… Before HHS government physicians conceded that Hannah’s July 2000 vaccinations triggered her encephalopathy, my only VICP activities were signing a short original petition and submitting a required sworn parental affidavit, first in 2002 and updated in 2006. Otherwise, I had no involvement in my daughter’s case, or in any other child’s ‘vaccine court’ process… Dr Zimmerman’s December 2007 letter was the only VICP involvement of any coauthor.

…There are certainly other physicians who have chosen not to publish promising leads or discoveries involving family members, out of respect for privacy or fear of the kind of criticism our article has generated. I suggest the JCN explore ways to encourage these helpful contributions, even when the patient is a family member. [emphasis added]

In a separate Conflict of Interest Statement, Drs. Frye, Zimmerman and Shoffner offer their own explanation and apology.

The facts of the case were presented fairly and without our knowledge of the prior filing with the vaccine court on behalf of the patient… The report was submitted to the Journal of Child Neurology after this child’s case was filed through the U.S. Vaccine Injury Compensation Program, but before any proceeding occurred on this matter. In retrospect, a full disclosure of the relationship of the patient to the lead author and the submission of this case to the Vaccine Adverse Event Reporting System and the U.S. Vaccine Injury Compensation Program should have been made to the journal prior to publication. We regret this oversight. [emphasis added]

Whereas scientific journals generally publish amendments with simple titles such as “Errata” or “Correction,” Dr. Brumback’s response is emblazoned with the headline, “The Appalling Poling Saga.” In it, he recounts the chain of events that led to the report’s publication and the information that came to light two years later. His letter is illustrated with a reproduction of the manuscript’s title page, in which the authors explicitly declare that they “have no conflicts of interest to disclose.”

On January 29, 2005, Jon S. Poling, Richard E. Frye, John Shoffner, and Andrew W. Zimmerman submitted online to the manuscript website of Journal of Child Neurology (JCN) an article titled “Developmental Regression and Mitochondrial Dysfunction in a Child with Autism” as indicated on the manuscript title page. Peer review suggested acceptance of the manuscript without revision, which was done on March 31, 2005. On that same date, a copyright agreement signed by Jon Poling was received by the Editorial Office. On November 29, 2005, the accepted manuscript was assigned to an article batch scheduled for publication in February 2006 (volume 21, issue 2) and subsequently appeared in that issue. As can be noted from the title page, the authors claimed no conflict of interest at the time of initial submission nor did they notify the Editor-in-Chief or the journal office of any such conflict of interest during the 12 months following initial manuscript submission until publication.

In late February and early March 2008, a media frenzy developed over a story about the ruling of a “vaccine court” in favor of a 9-year-old Georgia girl named Hannah Poling. A recent New England Journal of Medicine article describes some of these media events. In the March 6, 2008, edition of the Atlanta Journal–Constitution newspaper, staff writer Alison Young indicated that the child’s case had been reported by her father in JCN.

In the United States Federal Register of May 21, 2003 (volume 68, number 98), on page 27829, there is an entry (“145. Terry and Jon Poling on behalf of Hannah Poling, Vienna, Virginia, Court of Federal Claims Number 02-1466V”) mentioning a filing under the National Vaccine Injury Compensation Program listing of petitions received. This occurred before the manuscript was submitted for consideration by JCN and clearly represents a conflict of interest. Yet the authors made a definitive statement to the Editor-in-Chief and to potential peer reviewers that there was no conflict of interest. To any journal editor, this is an appallingly troubling issue. Openness and transparency related to any and all potential conflicts of interest is critical to maintaining the integrity of science in general and of journal quality in particular. Whether the manuscript would have been accepted for publication if the authors had disclosed earlier the conflict of interest is now a moot point, but this does not excuse the behavior of the authors in not disclosing the conflict of interest at the time, despite their current apologies.

Although, according to the leaked testimony (available to be viewed on numerous websites), it does not appear that the JCN article was used in the legal proceedings, media linkage of the published article to the legal outcome implies scientific support from JCN for this legal opinion. Of course it is possible to view this media exposure along the lines of the quip: “There is no such thing as bad publicity—just publicity.” However, in order for journals to maintain credibility with the scientific community and the general public, it is essential that any conflicts of interest be clearly identified.

Beginning in January 2009, statements from all authors concerning potential conflicts of interest will be published as a part of each article. However, no written statement can substitute for honesty, good faith, and integrity on the part of authors. [Citations and illustration omitted; emphasis added]

In spite of their carefully worded conflict of interest statement, it remains unclear whether Drs. Frye, Zimmerman or Shoffner learned of Dr. Poling’s VICP claim during the months between the report’s original submission and final publication — that is, soon enough to retract and amend the explicit assertion that the authors of Developmental Regression and Mitochondrial Dysfunction in a Child with Autism “[had] no conflicts of interest to disclose” before it found its way into print. Their statement nonetheless indicates that Dr. Poling withheld information about a highly relevant potential source of bias while collaborating with his child’s doctors on her case report. Although Dr. Poling’s co-authors have been appropriately circumspect in their references to their young patient, a recent Scientific American article quotes the opinion of Dr. Shoffner — a leading authority on mitochondrial disorders — that Dr. Poling has “mudd[ied] the waters” with unsupported public speculations about the percentage of children who might be susceptible to mitochondrial dysfunction, and the likelihood that vaccines might trigger such dysfunction.

It is simply incredible that a doctor who convenes a press conference to announce the favorable outcome of his child’s legal case, and internationally broadcasts her photograph and story — including in a two-page spread in People Magazine — would suggest that he sought to “protect” her by failing to disclose his relevant personal relationship and financial interests in a report submitted to a specialist scientific journal. Equally incredible is his suggestion that he should be excused for his failure to disclose an unquestionably relevant legal claim — a claim with a potential value exceeding $1 million — because it had not yet reached the hearing stage, and because his attorney was navigating the slowly-moving procedural waters for him. Most incredible of all is his suggestion that neither he nor anyone acting as his agent — such as his attorney, who represents hundreds of other VICP petitioners — consented to the disclosure of legal documents which could only have been obtained from parties to the case.

With Developmental Regression and Mitochondrial Dysfunction in a Child with Autism, Dr. Jon Poling takes his place with Dr. Andrew Wakefield, Dr. Mark Geier and Laura Hewitson, Ph.D. in the ranks of researchers who have concealed relevant legal and financial interests in studies purporting to confirm a causal relationship between vaccines and autism.

I extend my respect to Dr. Brumback for his undisguised editorial outrage and his unequivocal affirmation of researchers’ obligation to fully disclose their potential conflicts of interest to the scientific community and the general public.

Comments


  1. Since I couldn’t say it as well as you said it, I’ll quote you:“I extend my respect to Dr. Brumback for his undisguised editorial outrage and his unequivocal affirmation of researchers’ obligation to fully disclose their potential conflicts of interest to the scientific community and the general public.”

    I agree with Dr. Brumback that Dr. Poling’s actions have been appalling. Kirby’s and Shoemaker’s actions are likewise appalling.

    How come Dr. Poling hasn’t publicly scolded Kirby for leaking all that private info and why did Dr. Poling haul his daughter in front of cameras at a PR event if he’s so concerned for her privacy????

    — Ms. Clark    Oct 3, 02:36 PM    #

  2. “How come Dr. Poling hasn’t publicly scolded Kirby for leaking all that private info”

    Strange, isn’t it? Something is not right about the excuses given.

    — Joseph    Oct 3, 03:57 PM    #

  3. This reinforces my view that Conflict of Interest is only important when it is not disclosed. If Poling had been open about his daughter that would have added poignancy to the paper but it would not have detracted from the data. Now we have to doubt the data until we get a satisfactory answer to the question, “Why did you lie about conflicts of interest?”

    — Mike Stanton    Oct 3, 05:05 PM    #

  4. Paul Offit has never acted improperly with respect to conflicts of interest. He has disclosed them appropriately. Some people just don’t like it that a scientific expert might actually contribute to the manufacture of a product that saves children’s lives. Go figure.

    Jon Poling, on the other hand, had about as big a conflict as you could ever try to imagine. His excuses are pathetic.

    Um, David Kirby, you like to write about conflicts of interest, don’t you? I’m sure you’ll be leaping right onto this one, even though Kathleen scooped you royally.

    — isles    Oct 3, 10:51 PM    #

  5. I have looked closely at Dr. Offit’s conflicts of interest.

    First, a conflict of interest is not a trump card. If someone acts appropriately, then you just weight the COI when making decisions based on what he/she said.

    Dr. Offit acted appropriately with respect to his COI’s. He informed official bodies of his patents at the beginning of meetings, for example. He voted to include a rotavirus vaccine in the schedule that was a direct competitor to the one he was developing.

    Dr. Offit currently has no financial COI that I can see. His patent royalties are set (he can’t increase them by what he says). He doesn’t consult for Merck anymore. He doesn’t have any more vaccines in the pipeline. He has independent sources of funding.

    Dr. Poling, for whatever reason, did not make his conflict of interest clear.

    Dr. Poling’s paper is on the list of papers important to the petitioner’s case in the Omnibus. His neglect in noting his COI affects more than just his own family’s case.

    I find it interesting that Dr. Poling wasn’t involved with developing the petitioner’s case. His involvement is minimal.

    The reason I find this interesting is that there is a story (I believe by the Poling’s lawyer) that the petitioners were prepared to go forward with the mitochondrial dysfunction as a key part of the thimerosal test cases.

    Yet, when Mr. Tom Powers was interviewed by Kent Heckenlively of the Age of Autism/Generation Rescue blog, Mr. Powers was noted as stating:

    “When I questioned Mr. Powers about whether this was a possible break in the case, he replied that the particular case dealt with a claimant who had a diagnosed mitochondrial disorder. As a result, it probably won’t have much of an effect on the other cases.”

    Now we see that they weren’t consulting Dr. Poling on this issue. He was the lead author on one of the key papers for this subject. He certainly had spent more time thinking about this subject than their expert witnesses. Yet, they weren’t consulting him? Even about his own daughter?

    — Sullivan    Oct 4, 10:09 AM    #

  6. Kathleen wrote, in her masterful way:

    “It is simply incredible that a doctor who convenes a press conference to announce the favorable outcome of his child’s legal case, and internationally broadcasts her photograph and story — including in a two-page spread in People Magazine — would suggest that he sought to “protect” her by failing to disclose his relevant personal relationship and financial interests in a report submitted to a specialist scientific journal.”

    Yes, it’s clear Poling is not credible. I wonder what they were thinking – I can just imagine the Polings conferring with their counsel, and deciding that it was much more important to try to spin this decision to benefit the other omnibus petitioners, than to protect his daughter’s privacy.

    — Jennifer    Oct 4, 05:13 PM    #

  7. I see it this way, maybe it went down like this—
    Cliffy tells the Polings that he wants to stage a national media circus using Hannah in the center ring and Daddy Poling said,…. “I don’t know…” and Nurse Poling said, “I have the perfect pink suit and matching pumps!”

    — Ms. Clark    Oct 5, 02:39 AM    #

  8. If, as Dr Poling says, the report was disclosed without his knowledge or consent, then Dr. Poling (or rather Hannah Poling on whose behalf Dr Poling is “supposedly” working) has an excellent case against who ever did disclose the report to the media. If it was Shoemaker, then there is an excellent case for malpractice. If it was one of the experts that Shoemaker hired, then by breaching the confidentiality agreement that Shoemaker must have made those consultants sign the consultant has opened themselves up to the legal liability.

    If Dr Poling does not try to uncover who disclosed the report and to recover damages from them on Hannah Poling’s behalf, then by his silence he is giving his consent after the fact.

    Dr Poling did try to give his consent after the fact, by petitioning the court to retroactively grant permission for the report to be released. As I understand it, the only thing the Respondent was unwilling to agree to was making the permission to release retroactive, a condition that Dr Poling was unwilling to not include in the agreement.

    If Dr Poling lied about the report being disclosed without his knowledge or permission, that is fraud. Committing fraud in a scientific journal article is scientific fraud.

    — daedalus2u    Oct 5, 05:12 PM    #

  9. The issue, which Poling refuses to acknowledge, is that one cannot author an article about a case in litigation without identifying the potential COI. The Daubert decision (U.S. Supreme Court) stated that authoring an article based on the litigation topic while a case is in litigation raises questions about the credibility of the manuscript and diminishes its relevance.

    When asked, Poling uses lame excuses such as absence of activity in the legal case. The issue of protecting his child’s ID is ludicrous. One of the well-known case reports in child neurology was a physician-parent’s description of his son’s seizures that later was called West syndrome. There’s no problem about parent reports — just inform the editor.

    The leak of the government attorneys’ document to Kirby had to be done by someone with access to this information. Obviously, it was not a government employee. The Autism litigation team and parents had access to the document. It was probably one of the attorneys or one of their employees and raises the question if, by this time, someone in the family knows that person’s identity.

    — anonymous    Oct 5, 06:37 PM    #

  10. Although noone has directly addressed the subject (to my knowledge), I do find it troubling that Poling placed himself as lead author of his daughter’s case report, with or without the VICP claim (although it’s certainly more troubling with). In my opinion, he should have recused himself entirely from authorship, in much the same way that he should recuse himself from acting as his daughter’s physician. More objective health professionals should have assessed and submitted Hannah’s case for peer review. In this way, conflicts of interest would have been eliminated and, most important, Hannah’s privacy and her appropriate care would have been ensured (at least until the VICP ruling).

    — B. Martin, MD    Oct 7, 12:06 AM    #

  11. Off-the-top-of-my-head general thoughts, written as if I were reviewing this paper for publication.

    These no doubt need thinking through further, but I hope they’re useful comments in the sense of “issues to consider” all the same. (At least that I get a chance to ruminate on for a bit!) Bear in mind that while I do read a small number of papers from the medical literature, I mainly work from the molecular biology literature (i.e. I have little first-hand experience of this type of conflict of issue and I am hardly an authority in this matter!).

    Personally, if I were a referee receiving Jon Poling’s manuscript for review with the disclosure that Jon Poling was a parent of the child whose case is reviewed, and only that disclosure, my response to the editor would draw the editor(s) attention to this and indicate that I thought appropriate options with respect to that disclosure, assuming all else is satisfactory, would be to either (a) publish the article, but with an editorial comment drawing attention to the fact that an author is a parent of the child to highlight this to readers and to protect the journal’s interests; or, if the journal was uncomfortable with this, (b) reject the article and advise the authors that the journal feels that case study should be done “at arms length”, i.e. no parental input other than responses to questions and the like. I would indicate that my inclination would be to fairly strongly favour the latter unless the information conveyed really was unlikely to be able to be obtained by more independent means. (I’m not in a position to judge this in the case of this case report, nor do I think it appropriate for me to attempt to.)

    For those not familiar with the general nature of academic publishing reviewing, the referees’ role in these things are usually to indicate and summarise to the editor any issues with the paper and suggest possible courses of action. The actual call made are the editors’: the referees act as a “review and commend” team with the editor(s) weighing the balance of argument and making the decisions.

    The reason I would call it this way is similar in spirit to the regular advice that doctors are best advised not to diagnose their immediate family for potentially serious illnesses, and instead pass their family members on to a recommended colleague who they consider impartial. To present material as science, you must be impartial; in principle, and you’d think in practice, being personally close to the subject would make this difficult. In the case where the information is honestly unlikely to be obtained by other means, option ‘(a)’ (above) might be justified (e.g. for exceptionally rare diseases for which the parent may have useful information to convey from long-term observation), but that an author is a parent should be made quite clear. (I would add that such observations would probably be considered anecdotal in nature.)

    If I additionally received news of a conflict of interest being a link to a court case involving any of the authors or the child, or the like, this would certainly raise the stakes and I would find myself indicating my discomfort plainly to the editor and invite the editors to indicate the position of the journal with regard to legal conflicts of interest, etc. If the connection looked too awkward, I would likely withdraw from reviewing the paper in addition.

    I wrote the above before seeing post 11, but I feel my words should stand. Too much to want to rework, anyway! :-)

    — Heraclides    Oct 7, 04:41 AM    #

  12. Heraclides,

    I generally agree with your assessment. Perhaps to put things a bit more succinctly…The disclosure of an author’s relationship to the subject must be made, and if this relationship is familial (or in some other way that compromises the subject’s identity with the article’s publication), the author is off the paper. And then there is the argument of maintaining appropriate objectivity in the medical/scientific literature.

    — B. Martin, MD    Oct 7, 11:45 AM    #

  13. Some good points above (number 12 and 13. However, the way the letter reads it was just a case study—essentially one case with laboratory work and a muscle biopsy indicating a mitochondrial disorder. This after documented evidence of a regressive encephalopathy. It appears from the “leaked” report that two of the physicians may have been treating, one being the diagnosis of Mitochondrial dsyfunction the other the regressive encephalopathy. It appears Poling may have just looked at the labs of other patients to determine any patterns.

    What really strikes me as odd…what does this case study have to do with the autism omnibus cases? No where does it say in the study that vaccines cause autism. It seemed to suggest that there may be other children with autism that have mitochondrial disorder and that it should be investigated. Where are people reading vaccines cause autism in this paper? Especially in light of what Shoffner allegedly said , it would seem unlikely that was ever the intent.

    — lacshmi    Oct 7, 09:59 PM    #

  14. I had a thought taking Dr. Martin’s idea one step further. If Poling was smart and really intended to manipulate things in the court then he should have been a ‘ghost writer’ rather than an author on the paper? (You know—twisting it like the big boys at Merck http://jama.ama-assn.org/cgi/content/full/299/15/1800)

    — anonymous    Oct 7, 10:44 PM    #

  15. Anon, thanks for pointing to Ross et al.'s JAMA paper, which raises legitimate and troubling issues in the field of scientific publishing. For counterpoint, see Merck's response (courtesy of Pharmalot). Also of possible interest is this brief piece from Neurology Today in which several journal editors share strategies for discouraging ghostwriting by industry writers, and for encouraging full disclosure of the authorship of scientific articles and all authors’ potential COI’s and sources of support.

    Fortunately, Ross et al. disclose their status as consultants to plaintiffs against Merck — especially appropriate given the fact that their paper discusses matters related to the litigation in which they were involved. It’s unfortunate that Dr. Poling did not do the same. Concealing COI’s is not okay when industry-sponsored authors do it, or anyone else.

    — Kathleen Seidel    Oct 8, 07:23 AM    #

  16. On closer reading of the JCN letter, I wonder how Poling can possibly be this disingenuous. The issue isn’t how the paper affected the court case, it’s how the existence of the court case affected the paper. Was Poling’s view of the data colored by his status as a VICP claimant? We don’t know. He may not even have known. But the fact that it’s a possibility is why failing to disclose his COI is a serious scientific misstep.

    — isles    Oct 10, 02:45 PM    #

  17. Failure to disclose clearly makes a study unreputable. However, the information provided in the study should make a scientist/humanitarian interested in doing the study again to determine why 1 in 150 children have autism. The data gathered on the cause(s) of autism would be welcomed by all interested stakeholders (e.g., caregivers, health care providers, immunization advocates, non-immuniztion advocates, vaccine industries). The scientific community recognizes that vaccines do not cause autism. There are many studies documenting this conclusion. However, the question still remains then what does cause autism. Figure out this mystery and and the vaccine/autism issue will be dismissed by all concerned.

    — Mona Wenger    Oct 14, 10:10 AM    #

  18. You have a legitimate, albeit minor, point that Jon Poling should have disclosed the subject of the article was his own daughter. However, you seem to want this issue to sprout legs and somehow discredit the science, and it doesn’t do that. You seem to want to somehow hint that because there was a possibly improper lack of objectivity of one author then the science itself must be bogus. That simply is not the case. If you believe that, then you are ignorant of the science involved, which is being reproduced.

    The problem is most likely your ignorance of the errors of amino acid metabolism being found in the families of autistic people. Why do you insist on blinding yourself to this science? Do you think if you find shrill ways of discrediting the emerging picture of immune-system irregularities and amino acid metabolism dysfunction in the autistic (a condition which could interact with vaccines in some cases if the vaccines cause fever) that you somehow are less “neurodiverse”? That’s a really absurd position.

    — m    Oct 14, 01:52 PM    #

  19. m, it is understandable that a father would want to protect his child’s privacy when publishing a scientific paper about his child’s medical condition. However, it should not have been necessary for Dr. Poling and his co-authors to make a false statement to the editor of the journal in order to do so. They could have disclosed to the editor the fact that Dr. Poling was father to the subject of the paper; the editor could then have determined how they might proceed. Instead, they submitted the manuscript to the journal, stating explicitly that they had no conflicts of interests to disclose. Dr. Poling himself has acknowledged that this was a poor decision.

    The more significant problem pertains to his failure to disclose his involvement in litigation involving the subject of the paper. In his own defense, he has argued that it was not submitted as evidence in his child’s case. Such a response disregards the social context in which this paper and others discussing a possible link between vaccines, autism and associated disorders has arisen. The current glut of petitions and lawsuits alleging vaccine causation of autism is the result of extensive collaboration and recruitment for almost a decade by a well-organized clique of attorneys, doctors, mail-order laboratories, academics, PR representatives, celebrity advocates, petitioners and plaintiffs. Mrs. Poling’s public posts to online autism discussion lists demonstrate that she and her husband were not isolated from that social context. A scientific paper has the potential to be presented as evidence in untold numbers of cases; COIs (whether disclosed or concealed) have the potential to affect the weight afforded that evidence by the court. It would be very naïve to assume that it never would have occurred to Dr. Poling at the time he wrote his paper that it might be submitted as causation evidence in other legal cases — including those involving other clients of his own attorney — even if he were to refrain from submitting it in his own.

    I have not “hinted that the science must be bogus.” I have focused on reporting on the circumstances surrounding the publication of the article, the editor’s response to discovering the concealment of the COIs, and the unfortunate fact that this is one of a number of recent papers discussing autism and vaccine injury whose authors have fudged on disclosure. The lack of disclosure does not automatically invalidate the data presented or its interpretation.

    My concern about the deliberate concealment of COIs does not equate to dismissal of the need for research on metabolic abnormalities that might disproportionately affect autistic people. This is valuable research and should be continued. The “absurd position” to which you refer is a product of your own imagination. I have never advocated disregarding the medical, educational, psychological and social needs and problems of autistic people and their families, and I welcome you to call my attention to anything I have written that might indicate otherwise.

    — Kathleen Seidel    Oct 14, 03:40 PM    #

  20. Should Kathleen avoid talking about the conflicts of interests because… that reveals that Mr. Poling could have motive to skew the outcomes of the study?

    That I do not find a valid reason.

    — Ivar T    Oct 17, 12:30 PM    #

  21. “In his own defense, he has argued that it was not submitted as evidence in his child’s case.”

    It was submitted as part of the Master Reference List by the Petitioners Steering Committee in the Omnibus Autism Proceeding at the time Dr. Poling’s case was designated as a test case.

    The omnibus proceeding was created in July 2002. Dr. Poling filed his VICP case in October 2002, and it was part of the omnibus proceeding. In January 2005, Dr. Poling submitted his paper to the Journal of Child Neurology, claiming no conflict of interest. The paper was accepted for publication in March 2005.

    In June 2005, the PSC requested an extension of time until mid-2006 to file expert reports, arguing that the science was developing and that peer-reviewed articles relevant to issues in the autism cases were due to be published during the year to come. The PSC didn’t mention Dr. Poling’s paper, and in fact represented to the Special Masters that none of the papers they were awaiting was being prepared in connection with their cases. Dr. Poling’s paper was published in February 2006. Coincidence?

    On September 12, 2007, the PSC filed its PSC Master Reference List: General Causation and MCVs, in which Dr. Poling’s article is listed on page 12. Five days later, on September 17, the PSC filed its list of test cases for its second theory of causation, which included the Poling case. Coincidence?

    The HHS filed its Respondent’s Report in Poling on November 9, 2007, obviating the need for a hearing in that case, and the case was withdrawn as a test case. During the subsequent hearing on the second theory test cases, there was no expert testimony based on the Poling paper, which also indicates that the paper was submitted in connection with the Poling case.

    In December 2007, the Polings filed expert reports in their case from Mark Geier and Andrew Zimmerman. We don’t have access to those reports, so we don’t know whether either of them relied on the Poling paper. It’s possible that they could have.

    The timeline of events suggests that Dr. Poling could well have written this paper with the intent that it be used as evidence in his case, and that it was submitted for that purpose. At the very least he should have disclosed his direct financial interest in litigation regarding the subject matter of his paper.

    — Anne    Oct 17, 07:33 PM    #

  22. This discussion is nonsense. How can a ‘case report’ be used to sway the science of Autism etiology? A case report is simply a condensation of the medical record, which the vaccine court has full access to verify any details/discrepancies from the case report. The bottom line message of the small study of lab abnormalities in other patients is that mitochondrial disorders in Autism might be prevalent, which according to independent researchers in Portugal is true. This blog and it’s comments are just an attempt to attack the messenger rather than any true issue with the message. COI’s are for studies (not case reports) where the investigator has a financial or personal interest.

    — AnonPhD    Oct 21, 02:22 PM    #

  23. AnonPhD, was there a “I am not missing the point” part of your dissertation that you, well, missed?

    — HCN    Oct 22, 11:40 PM    #

  24. Ms. Clark said:
    I see it this way, maybe it went down like this—
    Cliffy tells the Polings that he wants to stage a national media circus using Hannah in the center ring and Daddy Poling said,…. “I don’t know…” and Nurse Poling said, “I have the perfect pink suit and matching pumps!”
    —————————

    And I see another possible conversation-
    Nurse/Lawyer Mamma Poling says “You have a lot more credibility than Geier. You’re a real neurologist! Why don’t you write a paper about Hanah and get it published. That will help our case.”

    Daddy Poling thinks a minute and says, “But maybe they won’t publish it since I have a conflict of interest. Maybe I should take my name off, or at least disclose the COI.”

    Momma Poling says, “If you tell them we’re involved in a lawsuit, they won’t publish it. And if your name’s not on it, we won’t be able to get on the gravy train with you as an expert witness in other cases later.”

    “Oh, OK then”, says dad.

    Joe

    — Club 166    Oct 23, 10:28 AM    #

  25. Dear Ms. Clark & Kathleen et al.,

    You guys are definitely autistic, maybe even “idiot savants.” You have no ability to see anyone’s view but your own—true complete absence of empathy.

    Your little rant is not gaining legs and so you again stoop to ad hominem attacks.

    This is one of the least intelligent things I have even heard (and I read much BS from the neurodiversity crowd).

    Momma Poling says, “If you tell them we’re involved in a lawsuit, they won’t publish it. And if your name’s not on it, we won’t be able to get on the gravy train with you as an expert witness in other cases later.”

    How in the world does one become an expert on a topic by publishing a case report in a crappy low impact journal?!

    You should have King Paul O testify as an expert to save the day. Oh wait, he can’t because he would have to answer questions truthfully about his financial dealings including decimal points and zeros!

    Idiots!

    Fred

    — NotAutistic    Oct 23, 08:28 PM    #

  26. Fred,

    Since it’s me you’re quoting (but Ms. Clark and Kathleen you addressed this to) I’ll reply.

    I have no idea what Jon Poling’s motivation was in being an author on a paper describing something in his daughter. But if he truly wanted to protect her privacy, he never would have done it. If he truly wanted the most scientific objectivity, he would have left the writing to others, and kept his name off of it. And if he wanted to avoid a major conflict of interest in his legal case, then he would have waited until that case was adjudicated until he attempted to publish the paper.

    Hope that’s simple enough for you.

    Joe

    — Club 166    Oct 23, 11:14 PM    #

  27. As I see it, the fact that Dr. Poling did not reveal his conflict of interest – when he should have known one existed – when specifically asked by the journal is evidence of an intent to deceive.

    His protestations that he was not involved in the preparation of the legal case, etc. are irrelevant except to the extent that they confirm that he WAS aware that the legal case could be seen as a conflict of interest (COI) and, thus SHOULD have been reported.

    I have to fill out COI forms every time I publish a paper or give a talk outside of my own university. The presence of a COI does not invalidate what I write or say – and it would not have invalidated the case report on Hannah Poling.

    Failing – deliberately – to report a potential COI to a journal casts doubt on the data presented in the article because it establishes an intent to deceive. And it is not unreasonable to assume that if one of the authors was willing to be deceptive about COI that they might be deceptive about other things.

    Scientific publications are very dependent on trust – we have to trust that the authors are not trying to deceive us, otherwise the whole system breaks down. That’s why deception on something as seemingly trivial and irrelevant as a COI declaration can have a “ripple effect” that taints the entire paper.

    As for Dr. Poling’s wish to preserve his daughter’s anonymity – that is pure rubbish. I read hundreds of case reports a year and none of them reveal the patient’s name or other identifying information. If Dr. Poling were concerned that people might see that he had a case before the VICP and “connect the dots”, he would have taken his name off the paper.

    I find Dr. Poling’s “explanations” unsatisfactory. Even if his intentions were as pure as the driven snow, his failure to declare a COI to the journal has tainted – fairly or unfairly – his work and the work of the other authors.

    Now, does this mean that I will completely ignore their results? No! Case reports are already shaky ground upon which to base a hypothesis, so I already view the publication with some degree of suspicion. I will have to admit, though, that I will view any future studies involving Dr. Poling with additional skepticism, based on his now-established “track record”.

    Prometheus

    — Prometheus    Oct 24, 03:03 PM    #

  28. Ms. Seidel,
    You dissertation here is junk and Dr. BrumBACK needs to get himself a Spine. I don’t see anything Appalling about the case report. What are Brumback’s COIs? Does he receive any cash from Merck who made the vaccine that injured Hannah Poling? Does JCN receive advertising dollars that he feels could be threatened if he doesn’t come out strongly with this type of response. What was so Appalling—a sin of omission? Paul Offit’s sin of commission on the other hand turns my stomach—why didn’t the NEJM get upset that he illegally used protected health information to write his opinion article by discussing the case with Dr. Geoffrey Evans of HRSA.

    — anna    Nov 1, 10:03 PM    #

  29. There is more today:
    http://jcn.sagepub.com/cgi/reprint/23/9/1090 …“Openness and transparency related to any and all potential conflicts of interest is critical to maintaining the integrity of science in general and of journal quality in particular. Whether the manuscript would have been accepted for publication if the authors had disclosed earlier the conflict of interest is now a moot point, but this does not excuse the behavior of the authors in not disclosing the conflict of interest at the time, despite their current apologizies….
    However, no written statement can substitute for honesty, good faith, and integrity on the part of authors.”

    — HCN    Nov 5, 11:44 AM    #

  30. AnonPhD: “A case report is simply a condensation of the medical record, which the vaccine court has full access to verify any details/discrepancies from the case report… COI’s are for studies (not case reports) where the investigator has a financial or personal interest.”

    Dr. Poling is a Hopkins-trained MD PhD neurologist; Mrs. Poling is a nurse. How plausible is it that such medically sophisticated parents would have observed the signs of abrupt and dramatic neurologic regression in their daughter that they later claimed in their petitioner for benefits, but not sought prompt medical attention for her? The closer in time the Polings could put the appearance of signs and/or symptoms to the immunizations, the better their chances of establishing eligibility for a very substantial (>$1M) compensation award from the Vaccine Injury Compensation Program. The Court of Claims special masters are known for their willingness to believe the testimony of parents even when they can produce little or no documentation to support their claims about onset of signs and/or symptoms of injury. A published case report in a “non-crappy” (unlike where the Geiers publish their crap) pediatric neurology journal would only bolster their compensation claim. And there is no reason to believe that what the Polings alleged about onset was ever closely scrutinized by either the court or Dr. Poling’s co-authors, who did not attend the child contemporaneously. So no reason to be much solaced by the fact that a court reviewed records and to treat a COI in this instance as any less serious a matter than if there had been a “study” involved.

    Finally, it is remarkable how anybody who in any way would undermine the “vaccines-cause-autism” crowd gets slimed. Dr. Brumback, the journal editor, whose own area of interest in pediatric neurology is primarily that of neuropathology, is attacked by anna as undoubtedly not trustworthy himself, though she has zero evidence to support the calumny.

    — informed observer    Nov 12, 01:22 AM    #

  31. Dr. Poling left out several significant facts in the paper. Including that the case report was related to him, and that he was involved in a legal case that involved real money.

    What part of “conflict of interest” do you not understand?

    — HCN    Nov 12, 03:25 AM    #

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