A First Amended Complaint on behalf of 21 US and UK autism and vaccine safety ad

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January 28, 2010

False Testimony Denies Lancet Doctors a Fair Hearing

Read pdf of complaint here.(27 January, London) A First Amended Complaint on behalf of 21 US and UK autism and vaccine safety advocacy organizations against Drs. Horton, Salisbury, Zuckerman, Pegg, and Rutter alleging, inter alia, that they gave false statements and testimony as prosecution witnesses in the proceeding brought by the General Medical Council (GMC) has been filed today. The false testimony on the two core issues (alleged conflicts of interest and unethical research) has irrevocably corrupted the proceeding against Drs. Wakefield, -, and Murch, and deprived them of a fair hearing. The objective documentary evidence demonstrates that Dr. Wakefield did not have a disclosable financial conflict; that Dr. Horton (Lancet Editor) was well aware of Dr. Wakefield’s participation in MMR litigation, suppressed that knowledge from the public, and then feigned surprise six years later in order to shift “blame’ for publication of the controversial article to Dr. Wakefield; and that the Ethics Committee had approved the taking of additional biopsies by colonoscopy well before any of the 12 Lancet children were examined. We call upon the GMC to immediately dismiss the complaints against Dr. Wakefield, -, and Murch and begin an appropriate investigation against Drs. Horton, Zuckerman, Salisbury, Pegg, and Rutter.

Summary of the Allegations in the First Amended Complaint

This First Amended Complaint includes two new Counts against Professor Sir L. Rutter. Count VII alleges that he failed to disclose in at least four papers published between 2005 and 2009 that he had a crucial conflicting financial interest as a highly paid expert witness for the vaccine industry (and for the U.S. Government that defends industry in Vaccine Court) in at least three major litigation projects, U.S. litigation concerning mercury (thimerosal) as a cause of autism, the U.K. MMR litigation, and the U.S. Omnibus Autism Proceeding (concerning both MMR and thimerosal as causes of autism). Although Professor. Rutter’s non-disclosure of a conflicting financial interest is precisely the same as that alleged against Dr. Wakefield (involvement in MMR litigation), the scope of Professor. Rutter’s wrongful conduct is far worse, involving multiple litigation projects, at least four papers, and the more stringent modern disclosure obligation.

Count VIII alleges that Professor. Rutter gave false expert testimony in this FTP hearing by stating his opinion that Dr. Wakefield had a duty to disclose his participation in MMR litigation in the Lancet Case Series. In the alternative, Professor. Rutter misled the Panel by hiding his own non-disclosure of the same type of conflicting interest for which he condemns Dr. Wakefield. If Professor. Rutter doesn't honestly believe (although this would contravene the express language in the modern disclosure guidelines) that acting as a litigation expert on precisely the same subject discussed in his published papers (and on which he relies for his opinion in litigation) is a disclosable conflict, then he is falsely accusing Dr. Wakefield of breaching a non existent duty. Or, if he honestly believes this is a disclosable interest, then his testimony is false and misleading because he has concealed the fact of his own pattern of non disclosure.

Allegations in the Original Complaint Count I alleges that Dr. Horton knew of Dr. Wakefield’s participation the UK MMR litigation, did not consider it a disclosable interest, and hid this knowledge from Lancet readers in 1998. Dr. Horton’s claim six years after publication of the Lancet Case Series that it would never have been published had he known of Wakefield’s participation in MMR litigation was false because he was twice informed of Dr. Wakefield’s relationship with MMR litigation a year before and five days after publication. Horton, not Dr. Wakefield, decided that the disclosure of a "perceived" conflict (where no actual conflict existed) was simply not necessary as part of the published Case Series. He concealed the Lancet's knowledge of Dr. Wakefield’s participation in MMR litigation when the possibility of “litigation bias†was raised by a reader immediately after publication. Attachment 1 is a side-by-side comparison of the letters received by Horton four days after publication, and the redacted version published in May, 2008. By feigning ignorance of the Wakefield litigation relationship, and outrage at somehow being misled, six years later when the allegations were raised by Deer, Horton was able to shift “blame†for decisions he had made and information he had concealed to a scapegoat (i.e. Drs. Wakefield, .Murch, and ) once it had become evident that someone had to pay a price for the “unpleasantness†surrounding vaccine safety concerns. Moreover, Horton conspired with a “medical regulator†to motivate a GMC investigation while boasting that the GMC “had not a clue where to begin.â€Count II alleges that Dr. Horton’s informal “gag†rule barring publication of material critical of vaccine safety breaches his professional duty as Editor of the Lancet to support scientific freedom and freedom of inquiry and avoid censoring material that might be “politically†unpopular or critical of industry. Dr. Horton’s de facto “gag†rule censoring publication of science that calls vaccine safety into question obstructs justice by depriving the courts of the evidence they would need to find a vaccine caused injury and is an unprofessional and misguided attack on the ethics of scientists and lawyers who would work together to seek justice for injured children.

Count III alleges that then Dean Zuckerman falsely denied his knowledge that Dr. Wakefield would, if asked at the press conference accompanying publication, recommend the single (monovalent) measles, mumps, and rubella vaccines as a precautionary measure until the safety of MMR could be further examined. Dr. Zuckerman's claim that he was unaware that vaccines would be discussed at a press conference accompanying publication was false because he had specifically instructed Dr. Wakefield to urge continued use of the monovalent measles vaccine as a safer alternative to MMR. Attachment 2 is Dr. Zuckerman’s Jan. 22, 1998 letter instructing Dr. Wakefield to recommend the monovalent vaccines at the post-publication press conference (“It is vital, in your own interest and that of children, that you state clearly your support for monovalent vaccination.â€).

Count IV alleges that Dr. Pegg falsely claimed that the research biopsies for the Lancet children had not been approved by the Ethics Committee. Dr. Pegg’s claim that the research aspects of Lancet Case Series were unethical was false because his own Ethics Committee had approved the collection of tissue samples (as project 162-95) well before the first child was ever examined. Attachment 3 is the Ethics Committee Sept. 5, 1995 approval letter for research biopsies.

Count V alleges that Dr. Salisbury has seriously misled the public by making unsupported claims regarding MMR safety. Dr. Salisbury's claim that MMR has an “exemplary†record of safety is unfounded and misleading. Two of the three brands of MMR have been withdrawn for safety reasons He has misused his official position by attempting to discredit and silence Dr. Wakefield and others who have a moral and ethical duty, and a right of free speech, to criticize the safety of MMR. Count VI alleges that he has also concealed material information relating to the safety of MMR from the public.

The False Testimony Has Fatally Inflused this FTP Hearing

The allegations of false and misleading testimony are directly relevant to the core charges before the Panel. Not only did Dr. Wakefield have no duty under the then-applicable disclosure standard, it was actually Dr. Horton that concealed Dr. Wakefield’s participation in the MMR litigation, only to later feign ignorance to shift blame to a scapegoat for all the “unpleasantness†surrounding the debate over MMR safety. The research aspects of the biopsies on the Lancet children had in fact been approved by the Ethics Committee as Project 162-95. Professor. Rutter could not have honestly believed that Dr. Wakefield violated a disclosure obligation because he did not disclose his own much more extensive participation as an expert in defense of the vaccine industry in several papers. More generally, it will be impossible for the Panel to distill any remaining bits of honest testimony because the false testimony has been so pervasive and has infected the core subjects of this inquiry