January 28, 2010

Read pdf of complaint here.

http://www.ageofautism.com

(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, Walker-Smith, 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, Walker-Smith, and Murch and begin an appropriate investigation against Drs. Horton, Zuckerman, Salisbury, Pegg, and Rutter.

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 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 Walker Smith) 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.”

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.”).

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.

Vaccine-caused autism was first described in the medical literature by Sir Michael Rutter. In a lengthy review article on the biological basis of autism, Sir Michael described a genetic study of families affected by autism, from which some children were excluded on the basis that their autism could be explained by some known “medical condition of probable aetiological [causal] importance.” Sir Michael explained one of the exclusions: “Only eight of the cases can be regarded as having a probably causal medical condition, a child with epilepsy and a temporal lobe focus on the EEG [Electroencephalogram] who had an onset following immunization.” Rutter M et al., “Autism and known medical conditions: myth and substance,” J Child Psychol and Psychiat. 1994;35:311-322.

The “vaccine court” in the United States began compensating vaccine autism claims in 1991. See Kleinert v. Dept. of Health and Human Services (“HHS”), 1991 WL 30664, (Cl.Ct., 1991 (No. 90-211V) (seizure disorder after DPT which is under control and a condition known as over-focussing, similar in some respects to autism). Since then, the court has published at least nine more decisions awarding compensation for vaccine-caused autism. HHS has found the evidence so persuasive that it has conceded liability before trial in an unknown number of autism cases. In a 2001 concession, Hiatt v. HHS, a child with MMR-caused autism was awarded $5.1 million dollars. In a case conceded in 2007, Poling v. HHS, a child who received five vaccines (nine antigens) in one day, one of which was MMR, developed autism. See Kirby, “The Vaccine Court Document Every American Can Read,” Huffington Post (Feb. 26, 2008) CBS News: Court Links Hepatits B Vaccine to a Death.

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

Much of this case surrounds the boundary between clinical care and research on human subjects (requiring ethics approval).  GMC guidance specifically excludes “innovative therapeutic interventions” from the definition of “research.”  But this is precisely what the Royal Free was providing to desperately ill children.  For a disciplinary body ten years later to reclassify clinical care as “research” (putting the licenses of some of the most prestigious doctors in the world) strikes at the heart of the profession of medicine, and will forever “chill” quality care.

Growing Concerns Over Prosecution Misconduct

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:

Charge 39 defines a “disclosable interest” as including:

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. 

Contact:
Jim Moody
1101 30th Street NW.
Suite 300
Washington, DC. 20007
2920298-4766
202-246-6639 [mobile]
moodyjim@aol.com

Useful Websites:
www.ageofautism.com
www.nvic.org
http://thoughtfulhouse.org/supporting_research.php [science summary]
www.safeminds.org
http://safeminds.org/mercury/vaccines-and-autism.html [science summary]
www.fourteenstudies.com [critique of epidemiology studies]
http://fourteenstudies.com/ourstudies.html [science summary]

www.nationalautismassociation.org