MADRID A Spanish researcher HIV / AIDS is facing a hefty fine for violating the regulation of clinical trials. An appeals court upheld most of the verdict of a lower court against Vicente Soriano, a doctor at the Hospital Carlos III here and well known clinical investigator with hundreds of publications to his name.
Soriano is responsible for € 210,000 to conduct a clinical trial without the approval of the Spanish Agency of medicines and health products, failing to get insurance for the trial, and inform the meeting that he had his hospital ethics approval when he did not, according to the decision, which was released on January 14. But the court overturned a € 6,000 fine for obstructing the original investigation, which took place in 2010.
The clinical trial phase IV, Soriano registered on ClinicalTrials.gov in July 09, sought to determine whether HIV patients with undetectable virus in their blood levels can replace so-called protease inhibitors in their treatment of cocktail with a new potent compound, raltegravir, the first in a class called inhibitors integrase, which has fewer side effects. Soriano's team divided patients into three groups with different treatment regimens; a group raltegravir once daily instead of twice the standard. (Simplifying a treatment regimen may help patients adhere.) The study included 311 patients, 222 completed 24 weeks of follow-up; an article in HIV Clinical Trials in 2010 showed that raltegravir successfully removed the virus in all but 13 of them.
An anonymous tipster told the Madrid health service that the trial lacked the proper regulatory and ethical approvals, according to the court decision, and between 24 and 29 November 2010, the Department sent inspectors to examine the records of Soriano. In October 2011, a Madrid court issued a fine of € 216,000
Soriano appealed the fines on various points. the core of its defense, however, supported by three witnesses Spanish experts was that the study was retrospective and observational, and that treatment changes were in the normal range of what doctors might recommend for any patient.
One of the seven judges hearing the case in the Superior Court of Justice of Madrid agreed but the majority did not. They wrote in the verdict that "the call is to avoid that the proposed project not only a change in dose, but also a change in medicine." One of the expert witnesses seem to obscure the fact that patients have was put on a new type of drug by asserting without proof that they were already raltegravir, the court added. fines, two for "very serious" offenses and one for a "serious" offenses, has was the lowest allowed by law.
"This study was undoubtedly a clinical trial," which would need the appropriate ethical approval, said bioethicist Ruth Macklin of Albert Einstein College of Medicine in New York. After reviewing the study protocol Soriano, Macklin said that they are incompatible with observational studies.
Soriano refused to be interviewed about the trial or appeal, but in an e-mail to Science Insider, he said that he and his group are victims of "harassment" related to a dismantling plan of the infectious diseases group at Carlos III. The hospital is in the midst of a merger with the Hospital La Paz in Madrid; both are owned by the Madrid regional government and coins were scheduled for privatization until this week, when a court ordered the cancellation of plans.
It is not known if the hospital will take action against Soriano. While his appeal was pending, he continued his medical practice, but the ethics committee did not approve all clinical trials of its since March 2011, said Rafael Pérez-Santamarina Feijoo, CEO of the hospital La Paz. Now that the final decision of the Court is available, the hospital will assess how to proceed, says Pérez-Santamarina. A spokesman of the Medical College of Madrid said Science Insider that it has taken no formal disciplinary action against Soriano.
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