In many ways we are very fortunate in the UK. The vast majority of our doctors are beyond reproach; we have a mechanism to deal very publicly with the bad ones and, in the context of research, we have a pharmaceutical industry that generally regards the integrity of research as a high priority. Certainly the Association of the British Pharmaceutical Industry has a loud voice on this subject and has supported our small organisation on a level that has exceeded our expectations on many occasions.
Prior to 1990 it was unheard of for a pharmaceutical company to take action against a doctor. Doctors caught fiddling research would simply be paid off, blacklisted in-house and their data disregarded. Another company would pick up the services of the same doctor and the process would be repeated. The result was that ripping off pharmaceutical companies by inventing patients and fabricating vital information on the performance of a new medication became more common.
Unless controlled this kind of outrageous behaviour can potentially allow bad medicines on to the market; it can also prevent good ones from getting a product licence. Equally serious issues can arise for individual patients whose notes will show that they are receiving trial medication when they are not.
Imagine someone collapsing in the street and being admitted unconscious to hospital. Hospital staff need to know about other medicines being taken. They will telephone the patient's GP practice and perhaps speak to a nurse. She will look at the notes and advise the hospital that the patient is taking a trial drug for depression. A decision may be taken not to administer the first choice of medication to help recovery for fears of an interaction. This might well place the patient in jeopardy. The nurse in general practice would have no idea that this patient had never been clinically depressed nor given any trial medication.
The comments in the notes could have been placed to deceive the study monitor charged with the responsibility of checking that all was well. The monitor, and indeed the pharmaceutical company sponsoring the study is not entitled to know anything more than the initials and date of birth of each patient participating in a study. Notes are anonymised.
So why do people cheat? In sponsored trials it is for the money but in medical research (as opposed to pharmaceutical research) the motivation has much to do with ego and career enhancement.
As fraud investigators, our attentions are normally directed towards pharmaceutical research but our efforts are often hampered. Most (not all) pharmaceutical companies are willing to fund us to investigate concerns. When we have clear evidence of misconduct we endeavour to identify all other studies that a doctor has conducted for the previous five years. We advise the relevant companies that they may have problems. They look at their data and review their monitoring procedures and reports before coming back to us with instructions for us to dig deeper on their behalf.
Sometimes we have warned a company and the response has been that they are totally confident in the integrity of their data. In such cases we try a little harder with them, but it means saying "you don't think you have a problem, please pay us to prove you wrong!" Sometimes we have been reluctantly given the go-ahead and returned with the news that not one of their patients knew of their study or had ever agreed to take part.
The wall of confidentiality between doctor and patient can easily be used to avoid detection. Getting beyond this can be problematic. Data Protection laws and confidentiality have to be circumvented within the confines of the law. We therefore ask Health Authorities to pass letters to patients on our behalf.
These letters are carefully worded and patients are invited to complete and return to us a tear-off slip with their names and addresses. From the initials and dates of birth Health Authorities can find their details and despatch the letters without giving us any information as to identities. We tend to achieve a fifty to seventy per cent response rate. Occasionally there is an absolutely nil response because the doctor has been tipped off and warns the patients to expect a letter from representatives of a wicked pharmaceutical company that is retaliating, as he does not prescribe their products. Trusting patients will hand over their letters for him to deal with.
Quite often a patient will disregard our letter believing we have made an error, as they have never taken part in research. That's the whole point - they are in these trials, at least on paper, but do not know.
We believe there is a strong case for ensuring that all patients falsely listed as participating in studies must be made aware so that their medical notes can be checked. False entries are often made to demonstrate that they fit the inclusion criteria for a drug trial. Those false entries can affect future healthcare, insurance cover, employment applications and so on. The GMC state that it is not within their remit to check this and Health Authorities do not have funding to do it. This is a matter that must be funded and dealt with. We estimate that we reach only ten percent of these patients. What damage is done to the rest?
Peter Jay is Managing Director of MedicoLegal Investigations Ltd (MLI), a small company which investigates questionable research carried out by doctor. He was previously a Metropolitan Police Detective Chief Inspector and was also a salaried investigator for the General Medical Council (GMC) solicitors for six years.
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You can contact the author of this piece at mli.fraud@btinternet.com or write to Observer public affairs editor Antony Barnett at antony.barnett@observer.co.uk.
