Read pdf of complaint here.
This First Amended Complaint includes two new Counts against Professor Sir Michael 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 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.”).
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.
The Interest of the Complaining Organizations
The false testimony alleged in the First Amended Complaint has harmed, and will continue to harm, children by chilling and reducing funding for research into causes of and treatments for autism, and clinical care. The documentary evidence now reveals that there was no merit to the core allegations brought in 2004 by Complainant Brian Deer. Furthermore, the FTP proceeding has been irreparably tainted by false testimony. Accordingly, the Organizations in the First Amended Complaint ask that the FTP hearing against Drs. Wakefield, Murch, and Walker Smith be terminated immediately. Declaring this diversion at an end will facilitate a return to the urgent scientific and public health challenge at hand, finding the cause of and treatments for autism, and restoring public confidence in the vaccination program with an aggressive 'safety first" research agenda. The false testimony and the ensuing GMC FTP hearing have had the effect of delaying necessary research into cause and treatment for autism, and dissuading scientists from pursuing research relating to vaccines as a cause of chronic disease. The ultimate victims of this false testimony are children whose autism could have been prevented or more effectively treated.
The MMR Controversy
This inquiry does not address and will not resolve the growing controversy over MMR safety, and the safety of the vaccine schedule in general. In 2005, the prestigious Cochrane Collaboration concluded, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing is largely inadequate. The evidence of adverse events following immunisation with MMR cannot be separated from its role in preventing the target diseases.” Demicheli V, Jefferson T, Rivetti A, et al. Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev, 2005(4):CD004407. To date, the US Vaccine Court has paid 295 damage awards, and in vaccine injury cases decided since 1988 has paid $1.8 billion (an under-estimate of actual injury because of a very short statute of limitations).
The Vaccine-Autism Controversy
The US Vaccine Court (by decision) and the US Government (by concession) have concluded that vaccines, specifically MMR, can cause autism. The debate, and the need for reallocating research support, now shifts to how many children have been affected (for purposes of compensation) and how to prevent new cases and treat those already vaccine-damaged.
The “vaccine court” in the United States began compensating vaccine autism
In the most recent MMR case, the court found liability for MMR-caused ASD. See Banks v. HHS, 2007 WL 2296047 (Ct. Cl. 2007) (No. 02-0738V). The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine...a proximate sequence of cause and effect leading inexorably from vaccination to PDD (autism). The Court ruled in a subsequent MMR case, Zeller v. HHS, 2008 WL 3845155, that the vaccine caused brain injury and developmental delay.
The Threat to Clinical Medicine
In addition to issues of credibility, there is increasing concern of prosecutorial misconduct that the panel may wish to consider, including the intentional or negligent use of false testimony, withholding crucial evidence, and the mis-wording of a key charge.
Charge 39 Alleges the Wrong Disclosure Standard:
matters which could legitimately give rise to a perception of a conflict of interest in relation to your role as a co author of the Lancet paper.
This was not the disclosure standard applicable to Dr. Wakefield in 1998, which was:
The conflict of interest is a simple one. Is there anything e.g. a shareholding in or receipt of a grant or consultancy fees from a pharmaceutical company or a contract from a medical devices manufacturer that would embarrass you if it were to emerge after publication and you had not declared it.
The Lancet’s rules in 1998 allowed authors to judge for themselves what they considered to be a conflict and disclose as necessary. However, the disclosure standard charged by the prosecution invites the Panel to judge a disclosable interest by an objective “reasonable person” standard. This reflects the current and much more strict standard, developed beginning in 2001. Dr. Horton and several journal editors explained the development of this more objective approach to disclosable conflicts as “The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment.” Davidoff, M., et al., “Sponsorship, Authorship, and Accountability,” Lancet. 2001 Sep 15;358(9285):854 6. The prosecution charged the wrong standard because it had no evidence of Dr. Wakefield’s state of mind, and therefore could not prove, a violation of the subject standard extant in 1998.
Prior Approval of Biopsies By Ethics Committee
Documents recently released under the Freedom of Information Act reveal that Complainant Brian Deer was specifically aware the taking of biopsies on the Lancet children for research purposes had the prior approval of the Ethics Committee, and therefore that his 2004 allegation of unethical research was false. Presumably he turned over this document to the GMC; otherwise he would have risked exposure as a fraud for withholding key evidence following any serious initial investigation by the GMC staff. Thus, the prosecution may have known as early as Deer’s Complaint that the biopsies Attachment 4, had been approved by the Ethics Committee under project code 162-95. It is entirely possible that Deer withheld this document (although that would call into question his status as a bona fide investigative journalist), but a competent investigation should have uncovered the 162-95 approval. As alleged in the First Amended Complaint, Dr. Pegg (then Chairman of the Ethics Committee) gave false evidence and testimony by failing to acknowledge the 162-95 approval (perhaps because he failed to fulfill his duty under GMP to adequately investigate and prepare his testimony). Nevertheless, the actual approval letters for 162-95 were placed in evidence by Dr. Walker-Smith. See Ex. 38 (Sept. 5, 1995 Ethics Committee letter granting approval of project 162-95). Even if there had been no prior knowledge of the ethics approval on the part of the prosecution, the charges relating to the lack of ethics approval should have been summarily dismissed at this point. The 93 pages of GMC charges contain 89 references to 172-96 and specifically state there was no other applicable ethical approval. The pendency of allegations by an official body, GMC, of unethical research, now shown objectively to be false, causes ongoing harm to the accused doctors.
False Evidence and Testimony
The false testimony by five key prosecution witnesses has irreparably tainted this proceeding, undermining the guarantee of a fair decision. The integrity of the GMC is at risk in this proceeding. GMC has a solemn and vital responsibility to protect patients and public trust in the medical profession. But it is now clear that this prosecution was not brought in good faith, and should have been dismissed long ago. By re-labeling “innovative therapeutic interventions” and appropriate clinical care as “unethical research” and exposing the routine day-to-day decisions of a dedicated team of the country’s leading scientists to meticulous scrutiny at risk of medical license, the practice of medicine will become increasingly mediocre and a noble profession turned into unskilled labor. This case is more a witch hunt or show trial, brought to settle old scores, “blame” innocent scapegoats for actions and inactions taken by many of the prosecution witnesses, conceal the poor quality of care given to desperately ill autistic children, divert attention from the lack of adequate research on vaccine safety, and generally to cover a host of backsides. The “chilling” damage done to these hard-working and dedicated doctors and to doctors and scientists generally – and thereby to the children they care for – is incalculable.