March 2004 Issue 10



MMR Sunday Times Investigation
(22ndFebruary 2004)

The extraordinary tale of the problems found in the paper by Dr Andrew Wakefield (as published in the Lancet) concerning MMR and autism were shared with MLI in strict confidence whilst Brian Deer's fine piece of investigative journalism was under way. We were asked to advise on matters that were clearly quite alarming.
It is rewarding to know that our knowledge and understanding of research problems is recognised. Brian Deer's investigation reinforces our view, yet again, that in medical research there is far too much pressure to publish.
The damage done to the integrity of research is such that it places doubt in the minds of the public about all research. Tragically, as in this case, the information provided by Dr Wakefield not only throws doubt on the work of his colleagues within the medical profession it affects the decision-making process for parents who became totally confused about the rights and wrongs of MMR.

In October 1999 the Joint Consensus Conference on Misconduct in Biomedical Research (meeting in Edinburgh) issued a statement about research:

Patients benefit not only from good quality care but also from good scientific research. We all expect high standards of scientific and medical research practice. The integrity, probity, skill and trustworthiness of scientific and medical researchers are essential if public confidence is to be assured. In the design and execution of biomedical and healthcare research, public participation is essential. The Joint Consensus Conference on Misconduct in Biomedical Research was convened in order to debate, address and offer guidance on key questions because "every single case [of fraud and misconduct] reduces public confidence, abuses the use of public and charitable funds, and causes insult and frustration to the vast majority of careful, honest workers"

The Panel concluded their statement with the words:

What should happen next?

A national panel should be established - with public representation - to provide advice and assistance on request. The panel might:

Develop and promote models of good practice for local implementation

Provide assistance with the investigation of alleged research misconduct.

Collect, collate and publish information on incidents of research misconduct

We expect that this paper will be given the fullest possible dissemination by the sponsoring bodies and that the three Royal Colleges of Physicians and the Faculty of Pharmaceutical Medicine will convene at the earliest opportunity a meeting with the General Medical Council and appropriate partners to establish and consider the remit of the national panel.

Almost five years down the road there is no 'National Panel', neither is there any sign of a willingness to establish such a panel. One has to ask the question why? Is it simply that there are not enough 'gamekeepers'? It is frightening to think that something like an epidemic of measles may be required to spur on those who really should know better.
Peter Jay


Publication Ethics

The recent MMR controversy, and the comments of the editor of the Lancet, Dr Richard Horton, that he would not have published the article associating the MMR vaccine with autism had he known of Dr Andrew Wakefield's conflict of interests raises the whole question of publishing integrity. Recently MLI investigated a case where a whistleblower drew to our attention the likelihood that references cited by an eminent practitioner in several of the articles he had had published might not be accurate. We investigated a sample selection of his most recent papers and found a number of anomalies that we eventually drew to the attention of the GMC. The GMC declined to take any disciplinary action against the doctor in question, whose name must therefore remain confidential, but it did write him a letter emphasising the need for accuracy when citing references.

The extent to which the doctor we investigated had transgressed, and the anomalies we identified, included several instances where cited references were misleading, seriously misleading, inappropriate or incomplete and in our opinion the number of instances of serious inaccuracy justified our making an allegation of continued serious professional misconduct, which, it must be said, was not upheld by the GMC. To our amazement, the doctor we had investigated told us that "it is in the nature of a quote that it does not include the full text" and that "one usually omits what one thinks is less relevant in the given context". Taken to its logical conclusion, this means that, like the caterpillar in Alice in Wonderland, words or sayings can be quoted to mean exactly what you want them to mean rather than what their original author intended them to mean. In a scientific paper that cannot be accepted

In the light of the expressed concern of a number of editors to the Wakefield case, however, we now intend to bring this case formally to the attention of COPE, the Committee on Publishing Ethics, to which the editors of 80 journals, including the Lancet and the British Medical Journal belong.

It seems to us that this should be essential, not merely desirable, as the rationale for making licensing decisions could well be influenced by the reported published statements of others, on which the reasons for doing a study, or even the conclusions drawn from the completion of a study, have been based. Companies are urged to check that the references that they use, and particularly those that are chosen by authors of expert reports or of articles to be published are accurate. MLI now has experience of doing this in depth and is willing to conduct a reference review at reasonable cost.
Frank Wells


Patient Records

A pharma company in the UK recently asked us to trace the ethnic origin of eleven patients who sadly died during their participation of a UK study more than a decade ago. The parent company in the United States suspected an ethnic bias within adverse events during the trial and requested that the records of the deceased in the UK be examined to see if there were similar findings. We were able to trace the GP records of nine of the patients to confirm that there was no pattern to support the United States results. This type of investigation can be done very quickly, thanks to having good relationships with many UK PCTs.



Whilst we are hugely appreciative of the financial support received from some ABPI member companies the irregular flow of work still provides us with a survival challenge. Diversification is the only way forward to make ends meet and we have been fortunate enough to secure some investigational work for the General Chiropractic Council. This relatively small statutory body is determined to make certain that standards are maintained and we have been quite surprised to find the extent of their problems.

The law states that you are simply not allowed to mention 'chiropractic' or 'chiropractor' unless you are a registered chiropractor. However to avoid paying professional fees and to maintain an income when 'struck off' the register, some qualified chiropractors are treating members of the public by representing themselves as 'chiropaths', 'back pain specialists' and so on. This is clearly undermining the integrity of the profession, putting patients at risk and sidestepping accountability.

MLI's advice to anyone seeking help from a chiropractor? Ask to see confirmation of registration with their professional body.



Mike Wallace FCA, a vice-President of the ABPI and, until December 1999, managing director of Schering Health Care Limited.

Managing Director

Peter Jay MIPI, a retired detective chief inspector, later investigator to the General Medical Council solicitors and co-founder of MLI

Director and Company Secretary

Jonathan Jay MIPI, specialist fraud investigator formerly with the Army Special Investigation Branch.

Director and Consultant Medical Advisor

Dr Jane Barrett MBBS, AKC, FFPM, LLM, holds a master's degree in medical law, is Registrar of the Facuty of Pharmaceutical Medicine and is involved in training physicians & ethics committees in clinical research matters.


Dr Frank Wells FRCP FRCPE FFPM, Consultant Pharmaceutical Physician. Also co-founder of MLI.


Dr Richard Tiner MFPM DRCOG, Medical Director, ABPI.

Jonathan & Peter Jay are Members of the Institute of Professional Investigators



An initial examination of company documents to ensure the credibility and reliability of the evidence

Interviews of employees and other potential witnesses, including patients, who may be required to give evidence at a disciplinary hearing (and preparation of their evidence)

Forensic support (i.e. handwriting examination )

Liaison with PCT and LREC to facilitate investigation process

Preparation of statements of evidence and supporting documentary evidence for submission to GMC in preferred format


Liaison between GMC and complainants during the build-up to the disciplinary hearing

Completion of case and final preparation for hearing under the auspices of the solicitors acting for the prosecution

Maintaining contact with witnesses and offering necessary support prior to giving evidence (to reduce anxiety)

Alerting all medical directors of companies sponsoring studies with investigator under suspicion (following identification by LREC)

Training relevant personnel in fraud awareness, particularly in the light of previous cases, and providing instruction in interview techniques as needed

Providing additional services to subscribing companies

Promoting the integrity of the industry


MLI Website May 2007: 



In July 1996 Frank Wells, a doctor, and Peter Jay, a former detective, took up the challenge to reduce fraud and misconduct in clinical research. It had to be tackled such was the extent of the problem. In the absence of an official body to deal with and having the necessary expertise at their finger tips they embarked upon the challenge that many thought was too risky. They were deemed too vulnerable. MedicoLegal Investigations (MLI) was born regardless. In 1998, the investigation team expanded following the arrival of Jonathan Jay, formerly a sergeant in the Army Special Investigation Branch.

Since 1996, our confidence has been justified and over 80 studies at numerous centres have been investigated. Several medical practitioners presently await disciplinary hearings at the General Medical Council (GMC), three doctors have already had their names erased from the Medical Register, two were suspended, one awaits a preliminary hearing and other cases are currently under review.

The response from the industry has, generally, been excellent. The medical royal colleges, the Association of the British Pharmaceutical Industry (ABPI), the GMC and the British Medical Association (BMA) have shown their support. The most rewarding aspect has been the appreciation of patients who show initial horror at having been exploited followed by sincere and emphatic expressions of thanks for penetrating the wall of confidentiality once their exploitation was suspected.

Health Authorities and their research ethics committees are very co-operative. Confidentiality has never been breached and data protection laws are respected. The word is out that fraud / misconduct in the context of clinical research will not be tolerated in the UK and enquiries from Europe are now reaching MLI.

MLI has achieved recognition for its success in tackling research fraud. The ABPI Board of Management has demonstrated its support in nominating Mike Wallace (a vice-president of ABPI) and Dr Richard Tiner (ABPI Medical Director) to join the Board of MLI. Dr Jane barrett joined MLI in February 2002 as the new consultant medical adviser and joined the Board of MLI as a Non-Executive Director on 1st April 2002.


The link is: http://www.computer.brecon.co.uk/medico/about1.htm