March 2004 Issue 10

MMR and MLI

MMR Sunday Times Investigation
(22ndFebruary 2004)

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

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

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.