November of 2013 falls into my definition of recently
-- 20 months after the study was halted -- the varespladib data were presented at the American Heart Association Scientific Sessions 2013. "Lack of efficacy" is apparently a generous way of saying that patients with acute coronary syndrome were more likely to suffer heart attacks, strokes -- or even die -- following treatment with varespladib compared to a placebo.
"Despite prior experimental and observational data suggesting that varespladib would have beneficial cardiovascular effects, this trial proves the contrary, that it is actually detrimental to cardiovascular morbidity and mortality," said Dr. Stephen Nicholls, a cardiologist and investigator in the study.
Why did it take 20 months for results of the varespladib study to be known? Because Anthera refused to grant researchers access to the negative varespladib trial data, said Nicholls.
"This trial was appropriately conducted and a logical extension of the phase 2 program, and the sponsor [Anthera] did the right thing and accepted immediately the recommendation by the DSMB to terminate the study," Nicholls said, quoted in a story published by HeartWire.
"However, despite multiple requests and what was a contractual obligation, the sponsor [Anthera] did not provide the academic steering committee with the database for this study. In fact, more than a year after the cessation of this study, it was only at that point that we received the database, when the sponsor's license of the compound expired and the license actually returned to the original developer of the compound. We were very grateful that the second company saw it appropriate that these data be put in the public domain."
Anthera has not responded to a request for comment on the charges of misconduct alleged by Nicholls.
Fiasco 1: For their drug varespladib, they sat on results which showed harm to patients instead of benefit, kind of a bad thing to do. Here is the link: http://www.thestreet.com/story/12115378/1/two-drugs-designed-to-help-patients-actually-hurt-them.html?puc=yahoo&cm_ven=YAHOO
Fiasco 2: A link to how sloppy they were with the original lupus trial: http://seekingalpha.com/article/1006801-antheras-lupus-drug-gets-second-chance-after-clinical-trial-disaster
Agreed that lupus is a serious disease which has unfortunately had very little advances toward treatment. The AMG 557 lupus trial with an Ab to a component also involved in B- T- cell interactions (like the ANTH drug) is moving painfully slow but continues to add sites/patients. ANTH seems to rush through their trials, apparently too fast. They could still get this approved if it shows benefit over benlysta, the so-so drug developed by HGSI.
Why would Amgen sell the best therapeutic candidate and keep the lesser one?
If they both work, the FTC wouldn't let Amgen buy ANTH and keep both drugs, would they?
Doubt that Amgen would buy them since they much more invested and potential in AMG557, the lupus drug they have partnered on with Astra Zeneca, Given the clinical trial fiascos that this company have had lately as well, just don't see this happening.