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Up to 5 Percent of Clinical Trials May Be Fraudulent
Daily Policy Digest

Health Issues / Drug Research & Development

Friday, February 08, 2002
The incidence of clinical research fraud is at least 1 percent and possibly as much as 5 percent, a British pharmaceutical fraud investigator told the Society of Biomedical Research in London. Dr. Frank Wells, director of Medico Legal Investigations Ltd, began investigating cases of suspected fraud 10 years ago.

When not discovered, fraudulent activity can affect the outcome of clinical trials used to determine the efficacy of new drugs or medical devices, leading to unnecessary deaths and disabilities. At the very least, it can involve misrepresenting risks to participants in clinical trials.

  • For example, one surgeon claimed to have assessed a patient 6 months after the patient had died.
  • Another doctor claimed to be assessing blood flow in the leg of a patient that had been amputated.
  • Another doctor had forged 191 patient signatures and other data in 21 studies.
According to Arthur Horowitz, an American pharmaceutical consultant:

  • Complaints filed with the Food and Drug Administration (FDA) against investigators increased from 11 in 1992 to 118 in 2000.
  • Violations of research protocols were involved in 35 percent of complaints -- and 25 percent involved falsification of data.
Sanctions -- such as disciplinary bodies that can revoke the licenses of doctors found guilty of research fraud -- do not yet exist in many countries. In France, silence is generally the golden rule on fraud. In Germany, rules about misconduct in science were only introduced a couple of years ago. In Italy and Spain, there are no antifraud measures worth reporting. In the United States, the maximum penalty under FDA rules is to be barred from federal research funding for 3 years.

Source: "Up to 5% of Clinical Trials May Be Fraudulent," Reuters Health, January 15, 2002.

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