Spanish HIV researcher Vicente Soriano is liable for a €210,000 fine after violating clinical trial rules and lying to participants over ethical approval.
The researcher, a physician at the Hospital Carlos III who has hundreds of publications to his name, must pay the fine after conducting a clinical trial without approval from Spain's regulator the Spanish Agency for Medicines and Health Products and failing to obtain insurance for the trial. In addition, Soriano informed participants of the trial that he had the hospital's ethical approval, despite the fact he did not.
Registered on ClinicalTrials.gov in July 2009, Soriano's phase IV clinical trial sought to examine whether HIV patients with undetectable levels of the virus in their blood could replace "protease inhibitors" in treatment programs with a new drug compound, raltegravir, which has fewer side affects. The patients were then divided in to two teams, of which one would take raltegravir once a day, and the other twice, which is the standard protocol in the treatment of HIV.
In total, 331 patients were enrolled; of which 222 completed 24 weeks of follow up. In 2010, a paper published on the trial shows that the drug cocktail was able to suppress the virus successfully in all but 13 patients.
After a whistleblower told Spanish officials that the trial lacked proper approval and regulation, examiners inspected the trial's records and the researcher was fined. Soriano defended the trial by saying the treatment changes were within the realms of what doctors might normally recommend for a HIV sufferer.
Via: Science Insider