History of research fraud gets physician job in clinical R & D at J & J

Let's just say if I worked for a J & J company, I'd be firing off one hell of a letter of complaint and possibly submitting a letter of resignation (without another job, no less) first thing tomorrow morning. I work in clinical drug development. Every company I have worked with (when I worked at the hospital) and have worked for (since selling my soul to industry) avoids using a physician who has a known history of committing research fraud as an investigator (not as principal investigator, not as a sub-investigator working under the principal investigator's direction). I highly doubt that the QA or Clinical Operations departments any J & J company would have approved former Brigham and Women's Hospital and Harvard Medical School physician Andrew Friedman as an investigator conducting one of their clinical trials in 1999. I also highly doubt any ethical IRB (Institutional Review Board) would approve him as such either. You see, Dr. Friedman committed the exceptionally unethical crime of falsifying data; he created patients and patient data for study subjects. His boss hot on his heels, he eventually confessed, apologized, retracted articles and was punished.

At the time he started cheating, Friedman was in his late 30s, married and a father of two young children. Following the path of his father, grandfather and uncle who were all doctors and medical researchers, he was an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and chief of the department of reproductive endocrinology at Brigham and Women's Hospital.

His reputation was tremendous and his work groundbreaking. His 30-page resume highlighted numerous awards and honors, lectures in Canada, Europe and Australia, and more than 150 articles, book chapters, reviews and abstracts. Of those, 58 were original research articles, where he had designed studies, conducted clinical trials, enrolled patients, collected and analyzed data and made conclusions.

In the end, investigators found — and Friedman confessed — to making up information for three separate journal articles (one of them never published) involving hormonal treatment of gynecological conditions.

He testified that he was working 80 to 90 hours a week, seeing patients two days a week, doing surgery one day a week, supervising medical residents, serving on as many as 10 different committees at the hospital and the medical school and putting on national medical conferences.

He did seek help, both from a psychiatrist, who counseled him to cut back, and from his boss, who demanded Friedman increase his research and refused to reduce Friedman's patient load.

That was 1996, Friedman was censured and barred from conducting federally funded research for 3 years, he also lost his license to practice medicine. When that 3 years was up, he successfully petitioned to have his medical license reinstated. Shortly thereafter, he was hired by Ortho-McNeil Pharmaceuticals (a J & J company) as Director of Clinical Research, he has since been promoted to Sr. Director of Clinical Research. His job description includes, but is not limited to

designing and reviewing clinical trials for hormonal birth control, writing package insert labels and lecturing to doctors.

He's also been in the media discussing safety issues of the birth control patch.

I'm sure Friedman is mortified about his past and truly was repentant for his actions. I have no problem with his license being reinstated as there were no allegations of medical malpractice, patient coercion or disregarding the health & safety in the treatment of his patients, but I strenuously object to him having any position in clinical research/drug development. If Dr. Friedman did not want to go back into clinical practice and J & J is comfortable with his qualifications as a physician, he should have been offered a job on the commercial side of the pharmaceutical industry, not in clinical research. His continued employment in such a position is not only a black eye for J & J, it's a blight on the entire clinical research/drug development community (one already marred by the Vioxx & Borison scandals, among others).

Tags:clinical research; drug development; ethics; fraud; pharmaceuticals; Health; medicine; contraception

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