Data released at the American Heart Association meeting in Dallas over Anthera’s discontinued Phase III cardiovascular disease drug varespladib has taken researchers by surprise: the company pulled the drug from testing last year, and the data shows that it boosted the risk of heart attack and stroke among patients. The New York Times and FierceBiotech find the data dump has triggered a slew of criticism against the pharmaceutical company for failure to provide this information earlier.
The Cleveland Clinic’s Steven Nissen tells the NYT that Anthera “stonewalled every attempt to acquire the data,” and MedScape reports that the study’s lead researcher, Stephen Nicholls, has taken a similar stance, telling the publication that Anthera withheld data “despite multiple requests.” The NYT says Nicholls asserts Anthera also failed to provide the agreed-upon, six-month follow-up for the majority of the clinical trial patients, a gap the NYT says makes it hard to confirm the drug increased mortality risk.
Anthera tells Fierce it did not delay publication.
