The Expert's Blind Editorial Eye · 2007-10-09 10:30


Significant Misrepresentations
Mark Geier, David Geier & the Evolution of the Lupron Protocol
(Part Fifteen) • Related articles

Five months ago, I sent the following letter to the Editorial Board of Autoimmunity Reviews.

1 May 2007

On 10 November 2006, I sent a lengthy letter to Dr. Yehuda Shoenfeld, co-Editor-in-Chief of Autoimmunity Reviews, in which I expressed many concerns about a paper by Dr. Mark Geier and David Geier, The biochemical basis and treatment of autism: Interactions between mercury, transsulfuration, and androgens published as an in-press uncorrected proof on 27 October 2006. These concerns included not only the ethics of research described in the paper, but also possible conflicts of editorial interest arising from co-editor-in-chief Dr. M. Eric Gershwin’s service to plaintiffs in the Omnibus Autism Proceeding (OAP), in which Dr. Geier is also involved.

Dr. and Mr. Geier’s paper was eventually retracted, the abstract replaced by the non-explanatory statement, “This article has been retracted consistent with the Elsevier Policy on Article Withdrawal… The Publisher apologizes for any inconvenience this may cause.” After the retraction, I learned that Dr. Shoenfeld received compensation from the the U.K. Legal Services Corporation for his service to plaintiffs in the now-discontinued MMR litigation, in which Dr. Geier was also involved.

I received no response to my original letter to Dr. Shoenfeld. A paper copy which I mailed to his office at Tel Aviv University was returned to me, marked “Not at this address.” My 23 January 2007 follow-up email remains unanswered. Dr. Shoenfeld has also been unresponsive to email and telephone inquiries by the journalist Brian Deer, who sought information about the retraction for the British Medical Journal.

It is my understanding that retraction is generally reserved for substantiated instances of scientific fraud or misconduct. Although I am pleased that Dr. and Mr. Geier’s paper was retracted, I am disturbed by Dr. Shoenfeld’s reluctance to respond to inquiries or to offer a substantive explanation for the retraction. The obligation to full disclosure becomes particularly urgent when a retracted study pertains to pharmaceutical experimentation on vulnerable, disabled children.

Herewith attached is my response to another paper by Dr. and Mr. Geier, A clinical trial of combined anti-androgen and anti-heavy metal therapy in autistic disorders, the subject matter and much of the text of which are substantially similar to the article retracted by Autoimmunity Reviews. I hope to impress upon all who read this letter the urgent need for scientists to demand the utmost integrity of research published in journals with which they are associated, and to protest the publication of reports that do not meet those standards. The autistic children who are or may become the subjects of Dr. and Mr. Geier’s research deserve no less.

I call upon the members of the Editorial Board of Autoimmunity Reviews to search your scientific conscience; to offer a full, public explanation of your reasons for retracting The biochemical basis and treatment of autism: Interactions between mercury, transsulfuration, and androgens, no matter how great the risk of embarrassment to any of your colleagues; and to disclose the identities of the peer reviewers who voted to approve the paper for publication.

Thank you in advance for your attention to my concerns.

Cordially,
Kathleen Seidel

Two days later, I received a copy of a message to Dr. Shoenfeld from Dr. Alan Tyndall of the University of Basel. Dr. Tyndall’s question was brief and to the point:

Dear Yehuda,
What is the current official position of the Journal on this issue?
Alan Tyndall

Later that morning, another email arrived in my inbox, this one from Dr. Rolf Zinkernagel, recipient of the 1996 Nobel Prize in Medicine for his work in cancer immunology.

Dear Yehuda
This question about the Geier Paper raises of course highly public issues that are “dangerous”, which ever way you slice it. Therefore a straight forward clear answer seems to be the best because these things usually linger for decades in arguments of nebulous beliefs. Be as clear and as straight forward as possible within this journal.
Best regards
Rolf

Dr. Shoenfeld’s reply was swift, belligerent, and distributed to his entire Editorial Board.

Dear Rolf,
This issue between the lady and the Geiers is an emotional vendetta and not a scientific issue. The paper was not published in our journal!! We do not need any report to anybody except the authors why their paper was not published. I am aware of this lady “disease” also in other aspects and domains. She writes to all the world and it arrived to at a stage of nuisance. We have decided not to respond to any of her emails letters etc.
ys

I am grateful to Dr. Tyndall and Dr. Zinkernagel for their attempts to elicit from Dr. Shoenfeld a “straight forward, clear answer” to my questions. I do not assume that all members of the Autoimmunity Reviews Editorial Board concurred with his interpretation of my letter or his hostile evaluation of my mental and emotional state. The board includes forty individuals at the top of their specialty — busy, highly educated professionals undoubtedly capable of recognizing and rationally addressing serious ethical and scientific problems when they are confronted with them. The female Board members might be especially familiar with the sort of sexist ad hominem argument exemplified by Dr. Shoenfeld’s dismissal of my concerns as the product of a diseased lady engaged in an “emotional vendetta.” With that in mind, I refrained from pursuing the matter further.

In the months since his outburst, I have received no further communications from Dr. Shoenfeld or from any member of the Autoimmunity Reviews Editorial Board, and no further explanation of the rationale for retraction of Dr. and Mr. Geier’s paper has been added to the article page. Although it is pardonable to want to know who has refereed reports of ethically suspect research, several scientists and journal editors have given me a greater appreciation of the need to protect the identities of peer reviewers. Less senior scientists might be inhibited in their evaluation of studies by more senior scientists if they feared retaliation for a negative review. Editors and publishers who disclose peer reviewers’ identities may expose themselves to liability for breach of confidentiality.

Dr. Shoenfeld’s personally abusive response notwithstanding, I soon gained greater insight into my basic question, “How did such an ethical travesty even approach publication in a peer-reviewed medical journal?” Mark and David Geier soon filled the vacuum created by the absence of a statement on behalf of the journal or publisher with their own inconsistent, self-serving statements to the press.

Dueling Explanations

On June 26, ABC News featured Mark and David Geier in a report, Researchers Raise Eyebrows With Autism Findings, and posted several clips of interview footage on their website. In the Credibility Defended segment, père et fils responded to John Donvan’s questions about the retraction.

ABC: What happened with the journal that pulled one of your articles?

David Geier: We had an article in Autoimmunity Reviews which was invited, and the editor never really published it. It made it on the website, but it was not — the editor decided that it was not appropriate for that journal. So that’s why it was taken down.

Mark Geier: What really happened was that Neurodiversity wrote a letter to every single one of those people, and they basically said, we’re autoimmunity, hey, we don’t want any part of this controversy.

David Geier: The editor said that it was not appropriate for that journal. Because our article was on mercury causing autism, and they felt that it was not autoimmunity related.

ABC: Why did you submit it to that journal?

David Geier: Because the editor asked us to submit an article for their review.

Dr. and Mr. Geier’s explanations are inconsistent with information provided by the journal. This inconsistency raises troubling questions.

• Why would the editor of a journal on autoimmunity solicit a paper from Dr. and Mr. Geier, who have no demonstrable expertise in the field of autoimmunity, and whose research involves subjects completely unrelated to the focus of the journal? Did Dr. Shoenfeld anticipate that their contribution might provide insights useful to autoimmunity specialists?

• Why would a busy editor-scholar go to the trouble of preparing a paper for publication in the first place if it was not appropriate for his journal?

• Was the paper subject to peer review? Peer review (or a brief glance at a paper prior to distribution to reviewers) would be the appropriate mechanism to screen out an off-topic paper. Retraction is not.

• If the paper was “never really published,” why would the editor retract it? It is one thing for an editor to decline to publish a paper, and quite another for a journal to issue a retraction. Dr. and Mr. Geier’s paper is still offered for sale by the publisher. Consistent with the Elsevier Policy on Article Withdrawal, every page has been emblazoned with the scarlet watermark, RETRACTED. The same policy stipulates that articles in press — that is, articles that have been accepted for publication but which have not been formally published — may be withdrawn altogether, their content removed and replaced with a statement that the article “has been withdrawn according to the Elsevier Policy on Article in Press Withdrawal.” However, the revised statement on the abstract page does not refer to the “Policy on Article in Press Withdrawal,” but to the “Policy on Article Withdrawal,” and the article content has not been removed.

• Did Dr. and Mr. Geier agree to the retraction? The Elsevier Policy on Article Retraction by the Scholarly Community calls for a retraction note signed by the authors and editors. However, the revised statement on the abstract page does not include such a retraction note.

• Was the paper retracted (as David Geier asserts) because it was “off-topic”; or was it retracted (as Mark Geier claims) because the Editorial Board sought to avoid involvement in a controversy unrelated to the subject of the journal; or was it “not published” for reasons related to my alleged “emotional vendetta” (as Yehuda Shoenfeld suggests), in spite of its continued availability from ScienceDirect?

• If Mark Geier’s explanation is accurate, did the Editorial Board members consider the substance of the controversy over his research, or did they simply determine that controversy existed and choose to distance themselves from it? If Dr. Geier’s explanation is accurate, it suggests serious problems with the journal’s system for peer review. Sorting out precisely such “controversy” is the reviewers’ responsibility. Allegations of research misconduct should be investigated, not avoided, and findings should be disclosed.

• If David Geier’s explanation is accurate, was it appropriate for Dr. Shoenfeld to solicit and publish an article by him and his father on “mercury causing autism,” given the apparent conflict of interest created by Dr. Shoenfeld’s provision of expert services on behalf of plaintiffs in vaccine litigation and given the reasonable expectation that publication of this paper would benefit Mark Geier, whom at the time had been publicly identified as an expert on behalf of plaintiffs in the Omnibus Autism Proceeding? Dr. Geier could logically expect to bolster his testimony by relying on this new, allegedly peer-reviewed publication. Dr. Shoenfeld’s editorship and provision of expert services to plaintiffs gave cause for him to mitigate the apparent conflict by recusing himself, and should certainly have prohibited him from soliciting an invited article from Dr. and Mr. Geier.

• Why would a scientific editor or publisher take the extreme measure of retracting any paper for any but the most compelling reasons? Retraction of a study without consent from the authors can expose editors and publishers to legal liability and can result in litigation brought by authors whose reputations are thereby tarnished. Indeed, in 2005, Dr. and Mr. Geier pursued a defamation lawsuit against the authors and publishers of a 2004 article they felt unfairly maligned them. Why would an editor increase his own and his publisher’s risk by capriciously retracting an article by authors with this sort of litigation track record?

Bait & Switch

More recently, I discovered two decisions from the National Vaccine Injury Compensation Program (VICP) documenting the association between Dr. Shoenfeld and Mark Geier’s long-time courtroom associate and fellow Institute for/of Chronic Illnesses principal, Mr. Clifford Shoemaker.

In February 2007, Special Master Laura Millman of the U.S. Court of Federal Claims issued an Order filed to Lovett v. Secretary of the Department of Health and Human Services (HHS), addressing issues common to 57 petitions in the Hepatitis B Omnibus Proceeding (a consolidation of cases similar to the Omnibus Autism Proceeding).

Hearings in the proceeding were held in October 2004. Testimony was presented by numerous scientific experts about the possible causal relationship between the Hepatitis B vaccine and demyelinating diseases such as multiple sclerosis. Among these experts was Dr. Vera Byers, who offered her opinion regarding the maximum onset interval for a vaccine injury.

Dr. Byers’ opinion on the medically-appropriate temporal framework was that most authors have agreed on 30 days after vaccination. She also would not ascribe causation before four days after vaccination unless petitioner were experiencing rechallenge from a prior vaccination.

This opinion was not particularly helpful to dozens of Mr. Shoemaker’s clients for whom onset of symptoms occurred more than thirty days post-vaccination. Try as he might, Mr. Shoemaker was unsuccessful in persuading either Dr. Byers or HHS expert Dr. Roland Martin to double or triple the maximum interval allowed in diagnosis of a vaccine injury. After the close of the hearings, the Special Master ordered those petitioners to demonstrate why their cases should not be dismissed, given that their medical records and expert testimony did not support vaccine causation of their symptoms.

Mr. Shoemaker then asserted that:

certain articles and testimony of Dr. Y. Schoenfeld will prove his clients’ allegations

— that is, they would be able to prove a causal relationship if Mr. Shoemaker could be allowed to present Dr. Shoenfeld’s articles and testimony at a new hearing.

The Special Master was not swayed.

Unless petitioners show that this evidence was unavailable to petitioners at the hearing October 13-15, 2004 or before the undersigned issued decisions in the paradigm cases in 2006, petitioners may not resubmit evidence already submitted at the Omnibus hearing or proffer a different immunologist than the immunologist petitioners used at the Omnibus hearing in the hope that this immunologist’s testimony will prove cases of demyelinating disease whose onsets were longer than the 30 days both parties’ immunologists testified was the appropriate temporal relationship at the Omnibus hearing.

…Dr. Schoenfeld’s articles were published before 2004 and 2006 and petitioners had the opportunity of putting Dr. Schoenfeld on the witness stand instead of Dr. Byers if his testimony would have been more helpful to petitioners than hers was.

To relitigate one of the three issues because petitioners in some cases would not prevail because their onsets were after 30 days post-vaccination would defeat the whole purpose of the Omnibus proceeding to settle issues in common.

Mr. Shoemaker cannot claim ignorance of the Omnibus petitioners’ immunological expert Dr. Byers’ testimony. He was one of the petitioners’ attorneys at the Omnibus hearing and actively participated in it. In preparation for this lengthy hearing, Mr. Shoemaker must have consulted with [fellow petitioners’ counsel] Mr. Homer about what Dr. Byers’ opinion was. Since she would not go beyond 30 days for the onset interval, the time for Mr. Shoemaker to switch to another immunologic expert was before the Omnibus hearing, not afterward.

Mr. Shoemaker now implies in his responses to the undersigned’s Orders to Show Cause that he is going to relitigate the Omnibus issue of temporality… with the same [articles] filed in the Omnibus hearing and use a different immunologist, Dr. Schoenfeld, that he assumes would be better for his clients’ cases than Dr. Byers.

The Special Master gave Mr. Shoemaker three choices. He could accept her previous ruling, which was based on Dr. Byers’ inconvenient testimony; he could submit only newly-discovered evidence, not evidence or expert testimony previously available; or she could reopen the proceedings for presentation of evidence by all parties, not only on the issue of time of onset, but also on medical theories and logical sequence of cause and effect. He would not be allowed to “take another bite of the apple” and relitigate only those matters in which he had been disappointed.

Mr. Shoemaker’s abortive attempt to play an expert-witness shell game and substitute Dr. Shoenfeld’s testimony for that of Dr. Byers coincided with Dr. Shoenfeld’s alleged invitation to publish research sponsored by the Geier-Shoemaker Institute for Chronic Illnesses — research that lacked evidence of prospective independent ethical review, and that had little to no relevance to the subject of autoimmunity.

Merit & Speculation

In June 2007, Dr. Shoenfeld testified for the petitioner in Dunbar v. HHS, Mr. Bohn Dunbar, who suffered multiple adverse events after two Hepatitis B vaccinations. As in Lovett v. HHS, the petitioner was represented by Mr. Clifford Shoemaker, and the case was adjudicated by Special Master Laura Millman.

Dr. Shoenfeld expressed the opinion that Mr. Dunbar suffered a positive rechallenge in the form of a severe autoimmune reaction following his second vaccination; that he developed an avalanche of autoantibodies, possibly triggered by molecular mimicry, polyclonal activation, or bystander effect; and that there was a logical sequence of cause and effect in the case. Dr. Shoenfeld’s expert testimony was deemed credible and persuasive.

The facts of the case strongly supported vaccine causation of a cascade of debilitating health troubles that began within days of Mr. Dunbar’s second shot. These facts were copiously, contemporaneously documented in hundreds of pages of medical records. Twelve treating physicians thought that his problems were vaccine-induced; these included a Workmen’s Compensation doctor, “who presumably would be motivated to produce an opinion against granting worker’s compensation but did not.”

Special Master Millman found that there was a biologically plausible explanation, a logical sequence of cause and effect, and a medically appropriate time frame to support this conclusion. On September 14, 2007, the court issued judgment in Mr. Dunbar’s favor. (The lengthy Order details not only his extensive medical problems, but also the astronomical medical bills and questionable treatment inflicted upon him by “environmental medicine specialist” Dr. Andrew Campbell, whose professional license was suspended in July 2007 for medically unsupported, unnecessary treatment of patients with alleged toxic exposures.)

Cases like Dunbar v. HHS are the reason the Vaccine Injury Compensation Program exists — to provide fair compensation to individuals truly injured by vaccines, rather than to those whose allegations are primarily speculative and factually unsupported. Such cases represent a minority of claims brought to the VICP.

Regardless of the merits of his claim, a petitioner will almost always be able to find an expert willing to support his allegations if he shops around for one. Since the inception of the VICP, there has been a dramatic shift in the type of claims filed, from a majority alleging “table injuries” — that is, injuries for which abundant scientific evidence demonstrates that they can be vaccine-induced, and which are therefore compensable without requiring petitioners to advance a causation theory — to a majority alleging more speculative, “off-table injuries” and requiring a more stringent burden of proof.

That burden of proof is met, in part, through expert testimony, and there is a burgeoning market for it. The recent explosion of speculative claims guarantees many opportunities for such lucrative engagements, with payment by the no-fault Vaccine Program virtually assured. Only the most skeletal and poorly prosecuted petitions result in denial of attorney’s fees and costs — costs which run from $300-$500 per hour for the services of expert witnesses (although requested fees and costs are often significantly reduced by the court).

It is reasonable to anticipate that a sense of camaraderie and mutual altruism would develop among experts playing on the same team, whether they are highly-credentialed academics like Dr. Shoenfeld, or freelance entrepreneurs like Mark and David Geier.

An Eminently Useful Friend

Dr. Shoenfeld is an accomplished scientist with an extensive publication history, and is highly regarded in his field. He directs the Center for Autoimmune Diseases at Sheba Medical Center, and serves on the Executive Board of the National SLE (Lupus) Center at Hadassah University School of Medicine. He is Chief Investigator in an ongoing clinical trial of autoantibodies screening for multiple sclerosis and has conducted numerous other pharmaceutical studies. He is also Chief Scientist of GammaCan, a developer of intravenous immune globulin therapies for cancer, and a generously compensated member of the Scientific Advisory Board of Advanced Biotherapy, Inc.. His name appears on 1,224 academic journal articles indexed in PubMed.

In addition to his role as co-editor in chief of Autoimmunity Reviews, Dr. Shoenfeld edits Harefuah (Medicine) and the Israel Medical Association Journal. He serves on the Editorial Boards of Experimental Biology and Medicine and Lupus. He has written and edited numerous books, including several co-authored with Autoimmunity Reviews co-editor and OAP petitioners’ expert, Dr. M. Eric Gershwin.

As such, Dr. Shoenfeld cannot claim ignorance of medical ethics, international conventions regarding protection of human research subjects, and safeguards necessary for the maintenance of integrity in scientific publication. He cannot honestly deny the legitimacy of the many questions raised by the research conducted by Mark and David Geier, and facilitated and promoted by their mutual associate, Mr. Clifford Shoemaker.

The Jerusalem Center for Research offers educational programs on all areas of Jewish bioethics. Among the testimonials on its website is one from Dr. Shoenfeld:

The Jerusalem Center is instrumental in creating instructive and fruitful religious-secular dialogue concerning crucial issues of contemporary medical ethics.

Regardless of his rhetoric about the need for “dialogue concerning crucial issues of contemporary medical ethics,” it seems, alas, that such dialogue stops at the Autoimmunity Reviews editor’s desk.

Comments


  1. Interesting. This Shoenfeld guy was certainly pretty rude. What the heck is a “lady disease” anyway? I wonder if this would be a case of woo peddlers unfortunately managing to infiltrate peer-reviewed journals.

    Joseph    2007-10-09 12:14    #

  2. “Rude” is a very accurate description; “beyond unprofessional” is another. As for “lady disease,” I take it to mean “crazy woman,” from a man for whom English is a second language. With Dr. Shoenfeld’s note, I officially joined the ranks of those who have been publicly diagnosed as mentally incompetent by physicians they’ve never met. Although he does not appear to be a woo-peddler, his note shows that he is not above offering speculative, “result-oriented” testimony on subjects beyond his professional training and expertise. In this case, the subject is psychiatry; obviously, the intended result was to discourage his colleagues from addressing the questions I raised by casting aspersions on my mental stability.

    Kathleen Seidel    2007-10-10 08:20    #

  3. This is yet another example of the corrosive influence of the exchequer funded gravy train that is the Omnibus Autism Proceedings. It also provides a timely reminder that even the most able and distinguished scientists can be influenced by prejudice and inflated opinions of themselves.

    mike stanton    2007-10-14 07:47    #

  4. It’s really disappointing when a person devotes years of his or her life to reaching a high echelon of science and then sells out. Can the money offered by the autism petitioners really be more than this Shoenfeld’s integrity is worth? Or maybe he didn’t have any to begin with.

    — isles    2007-10-14 21:42    #

  5. Well one day people will believe me because I have been preaching the gospel that there is no “science” only a bunch of venial self seeking self aggrandising wanabe celebs out there, and that was as true of Watson and Crick and true of Newton too.

    Get wise and tell it like it is science is full of scumbags.

    laurentius-rex    2007-11-06 17:30    #