Pharma Has Its Nose In Clinical Trials

Nolan and Auerbach — Tue, 05 Dec 2006 15:05:52 +0000

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures.

To read more click here.

Drug scandal allegedly reveals pattern of scientific fraud at the FDA

Nolan and Auerbach — Mon, 24 Jul 2006 15:38:42 +0000

Phase III clinical trials are not necessarily scientifically valid. Misreporting data or its significance is emerging as a reality. Drugs that have become FDA-approved based upon fraud in the NDA process may be the subject of False claims Act liability.

For more information, see this News Target article.

Pharma 101 - Pharmaceutical Fraud » Products Evaluation

Pharma Has Its Nose In Clinical Trials

Drug scandal allegedly reveals pattern of scientific fraud at the FDA