Clinical Research Fraud: A Victimless Crime?

The subjects of a tampered trial are true victims, and they're not the only ones.
Feb 01, 2005

Speaking on clinical research fraud at the ACT Summit in Brussels last year, we were asked by someone why we were worried about it. "After all" he said, "surely it's a victimless crime?"

Much has been written about research fraud and there have been many high-profile cases. But there has been little—if anything—written about its impact on the victims. There are obvious victims: sponsoring pharmaceutical companies. But of great concern to us are the direct victims of the fraud: patients given inappropriate treatment or denied full safety assessment while taking an experimental drug. Then there are the invisible victims, patients of a doctor removed from practice having been found guilty of research fraud. We'd like to share the stories of some of these victims.

Many protocols require patients to be treatment-naïve or uncontrolled on present medication. When we interviewed patients in a depression study, we saw patient notes altered to make it appear that the patient fitted the inclusion criteria. The records showed that a husband and wife participated in the same study. Both agreed that they had been asked to take part in the study, both discussed participation, and both had signed consent forms. So what, the husband was asked, was his history of depression? "I've never been depressed in my life!," he responded. The doctor had explained that it would help his wife if he went into the study with her. "I did it all for her." On the face of it this seems almost comical, but he had had a miserable 12 weeks with every known side effect. His wife, however, complained that she had received no benefit whatsoever from being in the study. He had received the active medication, and she—who needed the drug—had received placebo. Both of them suffered; she was denied medication and he was treated for a condition he did not have. Furthermore, his notes now show that he suffered from depression, which may influence future choices of treatment, employment, and insurance.

Sometimes, the impact on patients can be financial as well as a loss of trust. One elderly woman on income support was phoned by her general practitioner (GP) late one afternoon. The GP needed her to come to surgery to have blood taken for tests. He persisted, and she took a taxi at a cost equivalent to two days food. We later discovered that she was in three studies at the same time, and that the blood samples were needed to fulfill the needs of the protocols. She had no knowledge of any of the studies, and was so distressed and appalled by the abuse of the doctor–patient relationship that she travelled to London (several hundred miles) to give evidence from a wheelchair at his court hearing. She died less than two weeks later.

She was not the only patient in that practice who adored her doctor. Many protested when he was charged with research fraud, and held a collection to fund his appeal when he was found guilty.1 When he failed to launch that appeal, the realization dawned that the charges were true. Thousands of patients were deprived of their doctor; despite his fraud, he was widely held in great respect and affection, and his patients found it hard to understand.

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