Absentee Lab Technicians, Fixed Studies
North Carolina-based Cetero performs early-phase clinical research and bioanalytics for many pharmaceutical companies, which use the results to receive FDA approval for drugs. Exactly which companies used Cetero’s services for FDA drug approval remains unclear, though such companies are being asked by the FDA to come forward.
A series of investigations—two 2010 inspections, an internal company investigation, and a third-party audit—uncovered “significant instances of misconduct and violations” at Houston’s Cetero facility. The FDA adds that “the pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated” between April 2005 and June 2010.
In those five years, laboratory personnel supposedly busy conducting studies were revealed in the investigations as not even being present in the Cetero facilities—in 1,900 instances. The FDA also suspects that Cetero “fixed” studies to skew outcomes or failed to mention others in their reports.
The regulators say that the investigation’s scope is “too narrow to identify and adequately address the root cause of these systemic failures.”
Root cause? Maybe greed is a good place to start.
Widespread Fraud in Big Pharma
Greed seems to be a common denominator between Cetero and Roche and Genentech, a Swiss-based pharmaceutical company and its US affiliate, which were probed by the European Medicines Agency and found to have failed to submit 80,000 reports of products marketed in the US that left 15,161 patients dead. Your doctor could be one of the may paid to falsify data to get published. Even the Mayo Clinic has stated that the last 10 years of cancer research is useless due to widespread fraud.