Examination of recent cases of clinical research fraud in the US3

Dr Robert Fiddes, President of Southern California Research Institute, falsified multiple clinical studies during 1992-96. Dr Fiddes ignored protocol inclusion criteria and either enrolled patients into the trial by falsifying medical history and consequently endangering patients or

Table 7.1 FDA regulatory actions: clinical investigators.

Years

Warning letters

Disqualifications

Consent

NIDPOEa

agreements

Drugs &

Medical

biologics

devices

1993-96

22

-

2

7

n/a

1997

3

10

0

1

n/a

1998

2

6

0

4

5

1999

10

4

2

5

2b

2000

13

10

0

0

5

"Notice of Initiation of Disqualification Proceedings and Opportunity to Explain. bOne resolved in favour of CI.

"Notice of Initiation of Disqualification Proceedings and Opportunity to Explain. bOne resolved in favour of CI.

FRAUD AND MISCONDUCT IN BIOMEDICAL RESEARCH 6 -| ,-, „

1 - n o H U IJ 1,11,11,11,11,11,11,1 IJ 1,11,—XUX—,—XL—,—,—j-U-L,—,

1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999

Year

Figure 7.8 Submissions of false information audit, 1977-99.

enrolled fictitious patients by using employees of the research institute. In an ear infection study, the study protocol required subjects to have a certain bacterial infection. Study coordinators were directed to purchase the bacteria from a commercial supplier and shipped them to testing labs, stating that the specimens had come from patients. In a contraceptive drug study, Dr Fiddes substituted PAP smears from unidentified subjects for those from study subjects; blood from staff members was used to create lab work for three fictitious subjects; and subjects who dropped out were reported as completing the study. In a hypertension drug study, subjects were enrolled without required washout period, false ECGs created, and staff members instead of subjects wore Holter monitors. The Fiddes' scheme of fraud was well conceived. The company monitors and FDA personnel never noticed any problems with Fiddes' bogus paperwork, which they reviewed during routine audits. If it had not been for a disgruntled former employee, Dr Fiddes would have still been in business.

The authenticity of patients is highly suspect when investigators use bogus identities and use names from obituary columns (Dr S), or other investigators recycle subjects three to six times; or there are unopened cartons of the investigational drug identified with patient codes, and the CRF is completed after subjects died. In another case, Dr Lv signed the following affidavit based on FDA observations: "I, Dr Lv submitted false data on the majority of the patients in the following areas: 1. In at least 22 patients, identical sections of ECG tracings were submitted on different examination dates. 2. Radiological reports on at least 10 of 31 records submitted did not correspond with the initial examination date and/or not signed by the radiologist. 3. Diaries were in part filled in by myself (Dr Lv). 4. At least 23 of 31 endoscopy exams reported in the case report forms were not performed."

1991-93 1994-96 1997-2000

Year

Figure 7.9 OPRR suspensions, 1991-2000. (Source: CenterWatch)

1991-93 1994-96 1997-2000

Year

Figure 7.9 OPRR suspensions, 1991-2000. (Source: CenterWatch)

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