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.
Comment by Dr Aust | February 14th, 2010
Well, Krigsman is not practising in the UK, so the GMC have no jurisdiction over him.
It is interesting that he has moved state from New York to Texas, though I guess he might still be practising in both places. Does anyone know if Krigsman was ever investigated by the New York Medical Licensing authorities in respect of what happened at Lenox Hill? There is an “Arthur Charles Krigsman” on the New York Medical licence list (equivalent to the GMC’s medical register in the UK), so - assuming that is him - he would appear to still be licensed to practice in New York State, whatever his “difficulties”.
I am pretty sure American States have separate medical licensing, so I don’t know if an actual judgement against a doctor in one US State (e.g. being de-licensed) would necessarily “carry” to another one. The issue of such judgements carrying across national borders, or even whether there should be openly accessible registers of judgments, is certainly something that has been debated. A major reason is specifically because doctors who have been found guilty of serious professional misconduct in the UK have sometimes turned out to have earlier “form” for misconduct or incompetence in another country, which their later UK employers couldn’t find out about easily.
Comment by Laurentius Rex | February 14th, 2010
How on earth do they get away with claiming such academic credentials? It’s like the rotten sinecures of the Church of England in times gone by when the wealthy Bishop might reward his freinds with the living of a parish he never ever attends to. It just beggars belief how this academic corruption occurs, it really stinks to high heaven.
All of it really is an insult to honest people like myself who have to go through ethical approval and criminal records clearance to undertake even social research with ‘vulnerable autistics.’
The academic publishing industry really needs to set it’s house in order and set up a black list of suspect and fraudulent authors, because we all suffer as a result of there misdemeanors
Comment by Squillo | February 14th, 2010
I would hazard a guess that they got the idea from the Elsevier debacle.
Comment by Squillo | February 14th, 2010
@ Laurentius
At the Big Medical School I sometimes work for, they have “volunteer faculty.” These are folks who are not official employees of the university and receive no salary. Often, they teach students and residents off-site at their clinics etc. They are thus allowed to say they are faculty members of BMS. At our university, clinicians can apply to become volunteer faculty, although I don’t know what kind of vetting process is used to select volunteers from among the applicants.
Comment by Mike | February 14th, 2010
Hi Dr Aust,
as far as I know Lenox Hill themselves tried to investigate but were frustrated by his lack of co-operation and vexatious litigation against them. When the New York Supreme Court upheld a motion by Lenox Hill to dismiss Krigsman’s court case he went to Florida originally and incurred a $1000 fine for failing to provide documentation of his CME in his licensure application. Then he went to Texas and incurred a further $5000 fine for omitting to inform the Texas board of the Florida board action and also for advertising his services on the Thoughtful House website before he was licensed to do so.
The only other evidence of action I have found is the report from the office of Human Resources Protection which investigated complaints against him and against Lenox Hill for failing to supervise him properly. Lenox Hill were exonerated and the OHRP were “unable to make a determination” regarding Krigsman. Their letter concludes by saying that
As a result of the above determination and the fact that the investigator is no longer able to see
patients at LHH, OHRP anticipates no further involvement in this matter.
I have just received a link to an NYU School of Medicine requirement for all research to comply with the DHHS “Common Rule” for the protection of human research subjects.
Part of their requirement is for researchers at NYU to use a designated NYU IRB. Krigsman clearly did not. If he wishes to claim NYU affiliation in his research he should be called to account by NYU for using an unauthorized IRB and for all his other breaches of research ethics. I am open to suggestions about who is the best person to contact at NYU. I intend to start with the IRB director, elan.czeisler@nyumc.org
Comment by Laurentius Rex | February 14th, 2010
Volunteering and then actually teaching, is a bit different from volunteering simply to get ones name on the roll and then doing nothing, that is abuse of such a system.
Comment by Squillo | February 14th, 2010
@Laurentius,
Agreed. Just pointing out that he may have TECHNICALLY had the right to say he was faculty. Also, he may not have actually taught a class at NYU, but it is possible that he had students/residents at his clinic to observe. It’s not totally clear from the passage Mike quotes. In any event, his ethics are suspect from any number of angles.
Pingback by blog-thing : Andrew Wakefield, the never ending story | February 15th, 2010
[...] it is so faithful to the master’s original that Krigsman even replicates Wakefield’s breaches of medical ethics. We are promised more studies and devastating proof that Wakefield was right along. This proof is [...]
Comment by Mike | February 15th, 2010
I hope that Krigsman does have the right to say he is faculty at NYU. Perhaps they will go after him for breaking faculty rules.
Comment by Dr Aust | February 16th, 2010
Hmmm… Universities are usually not happy for people to claim affiliation with them when it is not actually accurate. And especially if the person is doing something they would not want their name associated with. Which likely is the case here.
I find it very hard to believe NYU would continue any association with Krigsman after he was taken down like that by Lenox Hill - and if he has no current affiliation with NYU then it might come as an unpleasant surprise to them that Krigsman is still putting out stuff on which he uses “NYU” as an affiliation.
Apart from the head of the IRB you could also try writing to the Chair of the Department of Medicine, or Internal Medicine, Mike.
Comment by A mothers view | February 18th, 2010
Are any of you a parent of an austic child?My child has been brought from continual pain day in day out to bouncy and lovable through Dr Krigsman’s input and research. What you are trying to do is to deny autistic children of the specialist input they need. I live from day to day with my child and Krigsmans expertise has been the only thing that has really helped so please get of his case!
Comment by Mike | February 18th, 2010
To A mother’s view,
Arhur Krigsman is a doctor who has helped your child. That is good. But that does not give him the right to conduct research that breaches medical ethics.
Comment by David N. Brown | February 20th, 2010
In many ways, I’d say Krigsman is even shadier than Wakefield. The lawsuit is an alarming detail: It has been complained in “angel of death” cases that hospitals are reluctant to report suspicions about misconduct out of fear of being sued.
Comment by Dr Aust | February 21st, 2010
Via a lnk in a comment by “Peter” on this more recent post dealing with Thoughtful House, I found my way to this page on Brian Deer’s site that deals with Krigsman’s Texas medical licence hearing in 2005.
To summarise, there was some debate about giving Krigsman a Texas licence, due in substantial part to the Lenox Hill events, and Krigsman was only granted a Texas licence on a 5-3 majority vote.
One would imagine that if there was to be seen to be a recurrence at TH, or worse still a continuing pattern, of ’scoping kids without proper approval and/or not on the basis of clinical need, that the ***t would really hit the fan.
Comment by Anonymous | May 21st, 2010
Re Comment #1 about New York investigating Dr. Krigsman.
Writing a paper based on 143 consecutive colonoscopies and getting the findings he had was not of interest to New York or Texas. I tried.