domingo, 1 de julio de 2012
C(r)O_ño...con la CRO*: "orgasmos (datos) fingidos" para Boehringer Ing. En homenaje a Nora...
ST. LOUIS • Patient No. 28665 was helping a Chesterfield company test a drug dubbed the "female Viagra" but stopped showing up for exams in December 2007.
That didn't stop a staffer of the company, PPS Clinical Research STL, from claiming that six months later the patient came in for an exam, was diagnosed with medical conditions, had undergone tests and even had given a urine sample.
That admission was made in the company's guilty plea to a federal felony charge of obstructing a proceeding of a federal agency. The drug the company helped test, aimed at women who suffered from an unexplained lack of sexual desire, never made it to market.
As part of the plea, PPS admitted that it "corruptly influenced, obstructed, and impeded" an inspection by the Food and Drug Administration by providing false patient records in May 2010.
PPS recruited area women for two trials testing the drug, Flibanserin, which was aimed at women who suffered from what is known as hypoactive sexual desire disorder.
The drug and German drug manufacturer Boehringer Ingelheim were not named in the criminal court documents but were named in the parallel civil settlement.
Crowe said that Boehringer terminated PPS from the study after the problems surfaced.
Although the company said that the drug increased sexual desire in premenopausal women, the FDA's reproductive health advisory committee voted 10-1 in June 2010 that the drug was not significantly more effective than a placebo.
Less than four months later, Boehringer announced that it was discontinuing the development of the drug.
Boehringer did not respond to emails seeking comment.
Flibanserin en PHARMACOSERÍAS
(*) CRO: is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced (often domestically) on a contract basis.