Krigsman, Wakefield and Research Ethics
Arthur Krigsman has finally published a paper which is supposed to provide independent verification of Wakefield’s premise that gastro-intestinal disease and autism are connected. It is published in Autism Insights, an open access journal. There is nothing wrong with this except that Andrew Wakefield is on the editorial board of Autism Insights alongside one of Krigsman’s co-authors, Carol Stott. Like Krigsman, Stott works for Andrew Wakefield’s Thoughtful House. In fact the Editorial Board is dominated by Wakefield’s allies and associates. The editor in chief, Anthony J Russo has only two autism related papers listed on PubMed and one of those was co-authored with Krigsman, Wakefield and Bryan Jepson, medical director at Thoughtful House and also a member of the Autism Insights editorial board. Autism Insights has only published two articles since its inception in September 2009. I suspect that it has been set up with the sole purpose of publishing papers by biomed supporters that cannot find a reputable journal that will publish them. This would make it no better than the bogus journals that Elsevier set up to publish infomercials for drug companies posing as bona fide research.
I can understand why other journals might be wary of Krigsman. He lists his main academic affiliation as Assistant Professor of Pediatrics, New York University School of Medicine. However, under cross examination as an expert witness in the Autism Omnibus proceedings it emerged that although he was on the staff at NYU he had never taught a class there and had never been paid a salary.
RICCIARDELLA: Doctor, your C.V. states that you’re a clinical assistant professor at New York University. Is that correct?
KRIGSMAN: Correct.
RICCIARDELLA: Are you currently on staff there?
KRIGSMAN: Correct.
RICCIARDELLA: When was the last time you taught a class at NYU?
KRIGSMAN: I haven’t taught there.
RICCIARDELLA: You’ve never taught a class at NYU.
KRIGSMAN: I’m on staff there.
RICCIARDELLA: Are you salaried?
KRIGSMAN: From NYU?
RICCIARDELLA: Yes.
KRIGSMAN: No.
RICCIARDELLA: Have you ever been salaried at NYU?
KRIGSMAN: No.
One of the co-authors, Marvin Boris, also boasts an NYU affiliation, Associate Clinical Professor of Pediatrics, New York University School of Medicine. But NYU had nothing to do with this research. Krigsman used to work at Lenox Hill Hospital in New York but left under a cloud in 2004. Their IRB had turned down his research proposals on three occasions in 2001/2002 because they were concerned for patient safety and concerned that he might be performing invasive procedures for research purposes on patients for whom there was no clinical indication. Krigsman went ahead anyway and even announced his research when he testified before the United States House of Representatives Committee on Government Reform on ‘The Status of Research into Vaccine Safety and Autism.’ (June 19th 2002)
To check whether he was in fact carrying out research without IRB approval the Lenox Hill Medical Board asked to see the records of ten patients selected at random. Krigsman refused. [source] He even tried to sue the hospital and when his suit was dismissed, his resignation brought all inquiries into his conduct to an end. [source] Krigsman presented his research as a slide show at IMFAR 2004 Two years later there was a poster presentation at IMFAR 2006 which listed Krigsman as co-author. This time he claimed to have discovered measles virus in his samples. He also claimed to have IRB support for his research. There is no mention of measles virus in the current paper. But there is IRB approval from the Copernicus Group who provide independent oversight and scrutiny to researchers at institutions that do not have an IRB.
I do not know how rigorous Copernicus are. Perhaps it is just bad luck that as well as Krigsman they also gave IRB approval to the Geiers for a paper which had already been published using a fake IRB packed with business associates and family members of the researchers. Now they have approved research that was refused IRB approval at the hospital where Krigsman worked when he took the specimens from autistic children who underwent colonoscopies at Lenox Hill Hospital. Remember that Krigsman was turned down three times for IRB approval by Lenox Hill IRB. He first applied in January 2001 and
This proposal was rejected by the Hospital’s IRB on February 21, 2001, due to concerns that the procedure’s risks would outweigh its anticipated benefits.
This is a clear indication that he was refused permission to carry out colonoscopies or take biopsies for research purposes. A revised proposal was submitted in June to retrospectively analyse the results from 50 children who had already had colonoscopies that, according to Krigsman, were clinically indicated. A decision was deferred pending revision of the proposal. This revision of the revision was finally refused permission in December 2002 on the grounds that
Dr. Krigsman had not obtained informed consent from the subjects or their legal representatives.
Perhaps that explains the delay in publication because now, eight years after the event, he does claim that
Informed consent was obtained for each child included in the study.
Meanwhile, way back then, there were concerns about the 200 autistic children that Krigsman had already subjected to colonoscopies. Where these all clinically necessary procedures or was Krigsman using these children for research purposes without IRB approval?
On January 23, 2003, Dr. Jerome Waye, the Chief of Endoscopy; Dr. Armando Grassi, the Chairman of the Deparment of Pediatrics; Dr. Hary Ioachim, the Chairman of the IRB; and, Ms. Debora Marsden, Lenox Hill’ s Compliance Officer, met to discuss Dr. Krigsman predicament. In light of the IRB’ s concerns, Dr. Krigsman was advised that Dr. Waye s approval was required before he could perform any endoscopic procedures at the Hospital.
Dr. Grassi instituted a corrective action procedure, which is employed to review the situation whenever a hospital’s staff member’s activities are called into question. Here, there were concerns that Dr. Krigsman may have been conducting research without approval and that he may have performed invasive endoscopic procedures as well as tissue biopsies on autistic children without medical necessity.
Pursuant to the Hospital’s by-laws, a Deparmental Ad Hoc Review Committee was appointed to investigate. Two hundred of Dr. Krigsman s cases were reviewed and discussions were held with pediatric gastroenterologists. Concerns about the medical necessity of the endoscopic procedures persisted. The Ad Hoc Review Commttee recommended that Dr. Krigsman’s patients’ hospital charts be reviewed and that he be advised not to use information gathered from past patients without the IRB’ s permission. Following review of Dr. Krigsman’ s patients ‘ hospital records, the Hospital’s Medical Board still questioned the necessity for medical procedures performed by him. Since Dr. Krgsman had informed the Ad Hoc Review Commttee that his patients had undergone a complete work-up in his office prior to their hospitalizations, the Hospital’s Medical Board recommended that the Ad Hoc Review Committee randomly review ten of Dr. Krigsman s patients’ office records in an attempt to further evaluate the need for the procedures in question. Dr. Krigsman refused this request on June 2 2003. [source]
Krigsman then decided to sue the hospital. His suit was dismissed in April 2004 and Krigsman elected not to seek renewal of his contract of employment when it expired at the end of that year. As he was no longer employed by Lenox Hill this ended the Office for Human Research Protections‘ investigation into his conduct there.
To summarize
- Krigsman carried out research without IRB approval and without informed consent.
- Krigsman carried out invasive procedures whose clinical necessity has been questioned.
- Krigsman obstructed investigations into his questionable conduct and sued his employers in an attempt to circumvent due process by artful pleading.
- When this ploy failed he left the hospital rather than face a proper investigation.
- Now he has published his research, in breach of advice not to use information gathered from past patients without the IRB’ s permission.
