Peter

In the UK the integrity of the scientific database would seem to have been of little interest to criminal law, health ministers and successive governments, professional bodies and the universities, or indeed to the average man in the street. The one sector which has shown some interest and which has provided support for maintaining that integrity is the pharmaceutical industry. However, to skew the scientific database is an affront to science, scientists, sponsors of research, and those doctors -fortunately the vast majority - whose standards remain high. The dishonesty of a small minority of doctors who cheat, forge and fabricate in the conduct of clinical trials, creates havoc and pain for far more innocent people than the average man would realise. The degree of that havoc and pain should not be underestimated and there is a clear message from the patients who are exploited that their safety must be given priority.

The purpose of this chapter is therefore to show what can be done, informally, to put into place an effective mechanism for the prevention, detection, investigation, and prosecution of those persons - mainly doctors - who commit biomedical research misconduct or fraud, where no formal arrangements exist. The absence of official recognition to have in place a formal pathway for the investigation of alleged research misconduct has led to the establishment of a private independent agency, supported by the pharmaceutical industry, which fulfils this role. MedicoLegal Investigations Limited (MLI), the agency in question, could be compared to an unwanted pregnancy. For years in the UK there have been unanswered representations for an official body to handle suspected research misconduct. Whilst those who mattered agreed it was essential, there was no delivery. Although MLI was not what had been asked for, they have generally been accepted as the (perhaps provisional) answer. As an investigator with the solicitors of the British doctors' disciplinary body, the General Medical Council (GMC) and therefore having extensive experience of handling misconduct in all forms, it was clear that the cases which surfaced represented only a proportion of the total number likely to be committing fraud. They also featured dishonest doctors who had been up to no good for so long, that their total disregard for the possibility of detection indicated arrogance in the extreme.Their misdeeds were blatantly obvious.This in itself posed a worrying question: "Just how many fraudsters are avoiding detection?" There was a need for something to be done. MLI has now been in operation for over five years, formed as an amalgam of two individuals - one a detective, the other a doctor - who had, sequentially, been involved in the preparation of a number of cases of indisputable research fraud for disciplinary hearings in front of the General Medical Council, all of them found guilty of serious professional misconduct.

The mentality of the fraudster is interesting in itself. The avoidance of detection is a game; much personal satisfaction is derived from the power to deceive, whilst the luck of being caught, then let off free, is sheer encouragement to be fraudulent again. The "skill" is then enhanced by lessons learned and it becomes far harder to detect next time. A dishonest individual will regard the verbal warning as a demonstration of weakness rather than kindness or fairness.

The investigation of research misconduct by MLI brings them into frequent contact with patients. It is important then to explain the process for making contact and the manner in which patients who may (or may not) have been exploited are handled.

Pharmaceutical company monitors do not interview patients neither do they see documents that could lead to the identification of patients. They are in receipt of initials and dates of birth of those participating in studies but have to rely very heavily upon the integrity of the doctor employed as investigator at whatever site, hospital or general practice. The monitoring process requires access to source data as well as anonymised records created by the doctor, plus consent forms and patient diary cards. Once suspicions are raised and a MLI investigation is requested, the process follows a well-trodden path.

All information originating from the company is double-checked and as much corroboration as possible is gathered. Only when there are very good reasons to believe that patient safety may be in jeopardy, or exploitation is probable, are efforts made to make contact with patients. This is done through health authorities who maintain computer records of patients listed with general practitioners, or NHS Trusts if hospital-based research is under scrutiny. Carefully worded letters are sent to patients informing them that some research in which they may (or may not) have taken part is "being reviewed". The letters do not cause alarm but they do produce a 70% response rate and are sent by the relevant authority without MLI being informed of patient identities. Patients are asked to respond by completing a tear-off slip with their names, addresses, and telephone numbers agreeing to be seen informally at their homes or any other convenient location. Interviews are conducted sensitively and with great care. Although a frequent response is limited to three words - "Study?

What study?" - it is always possible that the doctor under investigation is guilty of nothing more than sloppy work. This is why no mention is made of "fraud" or "misconduct" until evidence to support such reference is available.

No information is passed to MLI regarding the identities of the patients; the health authority simply addresses the envelopes containing the letters. Data Protection legislation created an initial hurdle in that the use of data held on record by organisations has to be recorded in registration applications to the Data Protection Registrar (DPR), at the time of registration. The forwarding of letters to patients in such circumstances as these was not covered. However, correspondence between MLI and the DPR resulted in the acceptance of special circumstances. The latter used as a test for justification the anticipated wishes of patients, should someone suitably qualified suspect their exploitation. It was quite ridiculous to believe that the law could protect a dishonest practitioner from exposure and fail to protect patients whose safety might be in jeopardy.

Written statements are taken from patients if evidence of misconduct emerges. They are told that it might be necessary to attend a hearing in London. Anger arising from exploitation, worries about future healthcare and notions of revenge through litigation are addressed, as far as possible, at the time. No patient is ever given bad news and then left alone to ponder the implications.

Once completed, the case papers are passed to the sponsoring company for assessment by their lawyers before being sent to the General Medical Council. If no evidence emerges from such an investigation the matter stops there. No one sets out to "make a case" regardless, and no doctor should fear the chance of a mistake leading to his appearance at the General Medical Council. These investigations focus upon areas of dishonesty or recklessness so serious that misconduct has, in all probability, occurred.

The monitoring process is by no means the only mechanism for finding suspicion. Whistleblowers play a major role and partners in general practice or nurses are the most common sources of information. Chairmen of Local Research Ethics Committees (LRECs) have been known to receive complaints from patients direct; several NHS Trusts have reacted positively to their own concerns and a number of health authorities have reported incidents to MLI that led to investigations.

Once misconduct is clearly established at a given site, the Chairman of the LREC is notified and asked to supply a list of studies approved in the previous five years for that particular "investigator". The medical directors of all sponsoring pharmaceutical companies are then notified. They have three main choices. They may wish to take no action (usually if the development of a medication under trial has been abandoned for commercial reasons or lack of efficacy). They can arrange a "for-cause" audit or commission a full investigation by MLI. So devious are some of the deceptions perpetrated, that companies often come back to MLI stating that they are satisfied, beyond all doubt, with the integrity of the data in their particular study. However, in the light of our experience, they will usually still commission a full investigation and, in two recent cases, all patients shown as participating in apparently "squeaky clean" studies posed the same question when interviewed, "Study, what study?".The companies were horrified to find that they had been deceived.

The obtaining of public domain information from LRECs is motivated by concerns about patient safety and product licence applications. To read in the press of a doctor being struck off the Medical Register and realising that he was one of the main investigators in a study, the database for which was closed the day before, is very worrying indeed for a pharmaceutical company.

Once an investigator has been shown beyond all reasonable shadow of doubt to have submitted fraudulent data to a pharmaceutical company or contract house, it is essential in the interests of the public, the profession, and the industry that the doctor should be dealt with in a forthright manner, either by appropriate disciplinary process or by prosecution. In the UK referral to the General Medical Council is considered appropriate, for consideration by the Professional Conduct Committee.

An example of the cases in which MLI has been fully involved involves Dr Geoffrey Fairhurst, who, in the mid-1990s was in partnership with a much younger doctor, Dr David Edwards, whose own investigations worried him enormously, leading him to seek the help of Dr Frank Wells. Together they managed to assemble a case sufficient to trigger Preliminary Proceedings at the General Medical Council. Examples of other cases appear in Chapter 5 by Wells and the viewpoint of the whistleblower in the Fairhurst case features in Chapter 15 by Edwards.

Dr Fairhurst had exploited several of his older patients by involving them in clinical trials without their knowledge and taking samples of their blood or ECG tracings which he then used ostensibly as if from other patients.When Fairhurst faced the Professional Conduct Committee of the General Medical Council, he was found guilty of serious professional misconduct and the Committee made some important comments that exemplify the importance given to this type of case and that are therefore worth setting out in full:

Dr Fairhurst, trust lies at the heart of the practice of medicine. Patients must be able to trust doctors with their lives and well being. That trust must not be abused. Medical research is fundamental to the advance of medical practice and must always be conducted with scrupulous honesty and integrity. Where doctors intend to involve patients in clinical trials, it is essential they first give those patients a proper explanation. Patients have the right to know what is involved, and to understand the implications for them, before they are invited to take part. No such trial should ever be carried out without the consent of the patient. The trust of the patients is maintained through such understanding and consent.

The facts proved against you in the charge demonstrate that you have repeatedly behaved dishonestly and have betrayed the trust placed in you by your patients, in particular by involving them in pharmaceutical trials without their knowledge or consent. You have also abused the trust of your medical colleagues and those with whom you were collaborating in pharmaceutical trials. In doing so, you have undermined the reputation of the medical profession, and damaged the confidence of the public in the integrity of scientific research.Your behaviour has not only been dishonourable in itself, but has also placed the welfare of patients at risk.

In your case the Committee's concern is the greater because of the position you have held as a member of a Local Research Ethics Committee. The Committee have judged you to have been guilty of serious professional misconduct in relation to the facts proved against you in the charge, and have directed the Registrar to erase your name from the Register. The effect of the foregoing direction is that unless you exercise your right of appeal, your name will be erased from the Register 28 days from today.

Finally, the Committee wish me to add the following statement. All doctors are reminded of their duty to take action where they have good reason, as in this case, to believe that a colleague may be acting contrary to the standards of practice set out in the Council's guidance. Only in this way can the Council uphold the integrity of the profession.

The case of Dr Geoffrey Fairhurst highlighted a number of issues. The Committee's comments were more lengthy than usual and sent out a very clear message to the medical profession that it would not tolerate behaviour of that kind. It also recognised the plight of the whistleblower and emphasised the responsibilities of individual doctors who suspected wrongdoing. Fairhurst had been dishonest for a long time - the evidence clearly demonstrated that fact - but he was allowed to continue with the exploitation of patients and skewing the scientific database because no one stopped him.There used never to be a mechanism in place to deal with such matters and dishonest doctors were able to learn from their mistakes and take precautions to ensure that detection was harder in the future.

Curiously, in spite of all the evidence and publicity, and with representatives of a group of patients in support of Fairhurst present at the hearing, there was still belief in St Helens (near Liverpool) that he was the victim. There were meetings and collections for funds to fight his appeal. No appeal materialised.

Much criticism has been levelled against the establishment in the UK that no action has yet been taken to set up an official body to which all cases of research misconduct could be referred without prejudice and without delay for advice and, if necessary, investigation. Meanwhile, however, the informal investigatory mechanism described in this chapter has provided a service, which has enabled successful action to be taken against a significant number of fraudsters, using the formal disciplinary mechanism provided by the General Medical Council.

There are alternative legal options open to complainants within the UK and, obviously, in other countries. As far as the UK is concerned, in clinical research cases where there is prima facie evidence of exploitation and/or fabrication, there is a priority for considering whether or not the practitioner in question should continue to practise as a doctor. For that reason the chosen route is to the General Medical Council. However, one might argue that the potential for imprisonment in such serious matters is a live consideration when the merits of criminal proceedings are being pondered.

The problem with that lies with the degree of criminal responsibility. Forgery of documents may be difficult to prove, as handwriting evidence, although much stronger now, is easy to challenge. The obtaining (or attempting to obtain) money by deception from a pharmaceutical company for bogus research might be serious enough to justify a fine for a first offender but unlikely to merit imprisonment. The full act of obtaining by deception carries a maximum 10 years' imprisonment, but this is for persistent offenders. A first offender is unlikely to receive a stiff punishment, particularly as any lawyer will make it clear to the trial judge that the doctor will still have to face his own professional body once found guilty of a criminal offence. Leniency should therefore be anticipated. A criminal trial can take two years to materialise during which time a doctor may continue to practise.

Criminal proceedings will inevitably create difficulties for the legal process. Convincing a jury of guilt in cases where a seemingly charming doctor protests his innocence would be difficult in the extreme, especially if they do not understand the intricacies of clinical trials.The real fraudster has to be an accomplished actor otherwise he could not perpetrate deceptions. For these reasons, the UK's preferred route for bringing the medical perpetrator of clinical research fraud to justice is via the body which regulates the medical profession - the General Medical Council.

There is, however, no reason to prevent a complainant pharmaceutical company seeking to recover its financial losses, either in cases where a doctor has been found guilty of serious professional misconduct or as an alternative to GMC proceedings. It must be remembered that in cases where a doctor has obtained a few thousand pounds dishonestly, his actions overall may have been responsible for losses totalling hundreds of thousands of pounds. With that in mind it will happen, one day, that a complainant pharmaceutical company will seek full compensation under civil law.

Temptation to cut corners is always present in commerce. Conflicts of interest between profits, speed of product development, and patient safety are ever-present. Pharmaceutical companies carry a huge weight of responsibility to ensure that research and development have patient safety and scientific integrity as priorities over commercial interests. Some examples of irresponsibility witnessed by MLI have indicated a naive rather than reckless approach. For example, as a cost-saving exercise, a lone auditor may be sent to investigate concerns at a particular site. If dishonesty is suspected there must be two auditors - lack of corroboration may later weaken any proceedings and, in any event, the individual employee needs to be protected against a malicious response to his/her reports of malpractice.

One resounding message must be emphasised: whether we like it or not, fraud happens. When it happens in the clinical research context, patients are exploited, sponsoring companies or institutions are abused, and scientific integrity is compromised. It is in the interests of society that these are minimised and MLI will continue to strive to meet this objective.

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