Letter to Copernicus Group Re Ethics Approval of Krigsman Study

 Updated: See end of posting
Updated Again
After the GMC decision was made public, Wakefield's name was dropped from the Editorial Board of Autism Insights.

Clinical Presentation and Histologic Findings at Ileocolonoscopy in children with Autistic spectrum Disorder and  Chronic Gastrointestinal symptoms (Krigsman)

Sent a letter to Copernicus regarding the use of their non-institutional commercial ethics review board approval for the Krigsman study.   Here are parts of it.

Sirs:

I believe that your organization may have been taken advantage of by allowing your good name to be associated with research that was specifically refused IRB approval.

Today Dr. Andrew Wakefield and others was found by the UK Medical Licensing Board  (GMC) to have been part of a scheme for research on children, including colonoscopies, that was not clinically indicated WITHOUT the necessary IRB approval. 

Today, as part of countering this fact finding, groups supporting Dr. Wakefield, such as Age of Autism have made a splash about the research done by Dr. Krigsman, formerly of Lenox Hill Hospital, now part of Thoughtful House where Wakefield  is executive director.

 The PDF link is here. Autism Insights has an editorial board on which both Wakefield and Krigsman are members.

The Krigsman paper states
"Data  review  was  conducted  in  accordance  with Copernicus Group Institutional Review Board (IRB) oversight  and  protocol  approval.  All  endoscopic examinations  were  clinically  indicated  and  IRB approval was limited to retrospective review and compilation of fndings using  these procedures.Medical records were reviewed for 143 consecutive patients, with ASD  or  related  diagnosis,  referred  for  evaluation of chronic GI complaints, who underwent  subsequent  diagnostic  ileocolonoscopy  and  biopsy  for suspected  bowel  infammatory  disorders.  Age,  sex, developmental diagnosis, presenting gastrointestinal symptoms,  and  histopathologic  fndings were  tabulated. Patients were  referred  either  by  primary  care physicians or parents. Informed consent was obtained for each child included in the study."

and
 "All colonoscopies were performed  in  the endoscopy unit of Lenox Hill Hospital, New York."


This research should not have received your approval as it was the subject of IRB approval at the Lenox Hill hospital where it was refused permission, both as to the research nature of the colonoscopies and as to the informed consent when he changed the proposal to one that only looked at past cases. The hospital was very concerned that procedures that weren't clinically indicated were being carried out.  This was the subject of a court order dismissing a lawsuit brought by Dr. Krigsman Further documentation on Dr. Krigsman and Dr. Wakefield can be found here.

The issue at Lenox Hill was the issue at the Royal Free Hospital for which Dr. Wakefield and others may lose their medical license.  That there were highly invasive research procedures carried out on children for research purposes without having the necessary IRB approval. Procedures on children for which approval was needed.   One of the charges against Dr. Wakefield was related to the IRB statement in the infamous 1998 Lancet study.
Dr. Krigsman has been tidier when he stated
"All  endoscopic examinations  were  clinically  indicated  and  IRB approval was limited to retrospective review and compilation of fndings using  these procedures."

The  colonoscopies were done years ago, but Autism Insights only published the study in their 2:2010 issue.  Seems pretty deliberate to drag you into the Wakefield mess. Even for their own in-house peer reviewed journal they probably needed some IRB approval.  And they found you.

I doubt that you had the above publicly available informaton when you approved Dr.Krigsman's study. You should act very quickly to remove your IRB approval before you damage your reputation.

Updated February 18. 2010

On page 3, under the heading  Statistical Analysis (spss 16.1)  is the following:
The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki (6th revision, 2008) as reflected in a priori approval by the institution's human research committee.

The only institution involved was the Lenox Hill Hospital and  they turned down his research requests.