The clinical research department of a large pharmaceutical company carried out a large postmarketing surveillance study on its new cardiovascular agent. In the routine screening of the data, suspicion was raised that a certain doctor, Doctor X, had fraudulently generated the data. A site visit was initiated and the site monitor confirmed that it was highly likely that Doctor X had committed fraud.
After documentation of the case, it was drawn to the attention of the medical director, who decided to pursue the doctor for fraud. As was the company's custom, the medical director's intention to prosecute the case was drawn to the attention of the marketing and sales directors and the chief executive officer.
Three days after the joint staff meeting to discuss the case, a note was received from the national sales manager concerning Doctor X. The note read:
Doctor X is one of the best doctors that we have in the country for prescribing our whole range of products. Our local representative confirms that Doctor X is a "company friend" and any prosecution brought against Doctor X would have a major impact on our sales in that area. Not only is Doctor X a keen user of the company products but he has been used extensively to speak at local and regional meetings in support of our products particularly in light of his first hand knowledge of their use.
I therefore recommend to the CEO that no further action be taken against Doctor X despite the fact that the case seems proven against him.
The commercial decision not to prosecute Doctor X was upheld by the chief executive officer and no further action was taken. This, however, is not the end of the saga.
Unbeknown to the sales and marketing directors, the medical director had asked the research group to check their computer database to see if Doctor X had participated in other studies. Two or three days later it was confirmed that Doctor X had participated in at least two other studies and one large postmarketing surveillance exercise. The data were retrieved from these studies and checked, and a high index of suspicion that fraud had been committed in these studies was confirmed.
In addition the national sales manager, presumably out of interest, had been checking the representative call statistics to see how often Doctor X had been called on by the local representative. He was amazed to find that for the past two years Doctor X had been seen between 10 and 16 times a year despite the fact that the maximum call frequency allowed within the company was four to six calls a year even on high users of company products.
At this stage several people were getting extremely concerned and it was decided to check, through independent audit, whether Doctor X was in fact a high user of company products as he had claimed. As far as could be told from an in-depth audit using third party sources, Doctor X was in fact not a user of company products at all.
The myth therefore of the "company friend", the good doctor whom we do not want to upset, was in this case exploded. It was, however, serendipity that the investigation of Doctor X was carried further because of the interest of the medical director and the national sales manager. It is a salutory note that, despite the additional information, no further action was taken against Doctor X.
Not only was Doctor X defrauding the clinical research department, he was in fact defrauding the representatives and the company - particularly when it is borne in mind that the company was using him, and paying an honorarium, to speak about his first hand knowledge of company products to other doctors.
The dilemma posed by the unique relationship with the customer as the supplier, and the need to protect company friends, as illustrated by this case, is still a major hurdle to the industry's commitment to stamping out fraud in clinical research.
The position in the United Kingdom since 1989 has improved considerably. The positive approach taken by the Association of the British Pharmaceutical Industry and the very firm line taken by the General Medical Council (GMC) have reinforced the British pharmaceutical industry's decision to eradicate fraud from clinical research. The GMC in its 1992 annual report made the following comment:
The Council is bound to take a serious view of behaviour such as that outlined above [proved clinical fraud], in relation to clinical trials. Lack of care or dishonesty by doctors when participating in such trials is not only discreditable in itself, but is also a potential source of danger to patients, whose safety depends on the integrity and diligence of all those who participate in the testing of approved drugs.
This unambiguous statement has proved very helpful ever since in convincing companies and organisations to adopt an aggressive approach to suspected fraud.
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