Mar 28, 2014

Two drugs, two errors

Clinical trials are supposed to be overseen by independent monitors responsible for ensuring the safety of enrolled patients. If a drug is found to be causing patients harm, these monitors can halt the clinical trial.

Recently two different drugs harmed patients. One of them from Anthera Pharmaceuticals (ANTH) which involved a heart drug known as Varespladib, was stopped early in March 2012, although the reason given by the company at that time was "lack of efficacy." 20 months after the study was halted, due to Anthera refusing to grant researchers access to the negative Varespladib trial data, they were presented showing that patients with acute coronary syndrome were more likely to suffer heart attacks, strokes -- or even die -- compared to a placebo.

According to Dr. Stephen Nicholls, a cardiologist and investigator in the study, the sponsor [Anthera] did not provide the academic steering committee with the database for this study until a year after the cessation of it when the sponsor's license of the compound expired and returned to the original developer of the compound.

The other one, Vical's skin cancer "vaccine" Allovectin-7, also ended up putting patients in harm's way, according to detailed results from a phase III study presented at a medical meeting on 9th December. Here we learned that skin cancer patients were actually better off without Allovectin while the results of the study were delayed for years, causing Vical and its supporters to believe that it was due to the vaccine helping patients live longer.

Biotech investors are accustomed to reading about negative clinical trials in which an experimental drug shows no benefit for patients and, even today, to find drugs that harm them. This could be avoided if all the results obtained in the different studies were accessible to all.


Written by Dr. Belén Suárez for The All Results Journals.

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