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
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-na´ve 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.