Can FDA regulators be influenced by a grassroots campaign pushing for an approval of a controversial new therapy? A group of Arena Pharmaceuticals' investors are determined to find out as they gather signatures for a petition and mount a letter-writing campaign lambasting the negative vote handed down by an FDA advisory panel charged with reviewing the data for the obesity drug lorcaserin.
FDA staffers recently stunned a small crowd of analysts who track Arena by publicly unveiling preclinical signs of tumors in rats injected with the therapy. With the bar on safety raised to a very high level for obesity drugs, and a history of problems with side effects that has torpedoed a string of such therapies, a majority of panelists were concerned enough to vote against an approval. And as Forbes' Matthew Herper recently reported, a 'no' vote by an FDA panel is only rarely overlooked by the agency when it makes a final decision.
As the San Diego Union-Tribune reported, though, investors have been doing their best to whip up a last-minute victory for Arena, which saw its shares crater on the safety issue and panel rejection. Dr. Carl Peck, a former director of the FDA's Center for Drug Research and Evaluation, told the San Diego newspaper that the effort was "unprecedented."
The investors are making the case that the agency is ignoring its own guidelines on the subject, noting that when drugs are delivered at more than 25 times the normal amount the results don't relate to humans. And a cancer specialist or someone who understands veterinarian medicine should have been on the panel to explain that.
FDA officials say only that they are "looking into" the claims. But the chance any public campaign for a diet drug could gain traction among regulators and lawmakers is slim. The agency's demand that Dendreon pursue a new trial of Provenge despite a positive panel review was met with a furious outburst among cancer patient groups. And that did nothing to shorten the Seattle company's long trail leading to an eventual approval. Diet drugs don't spark nearly the same sort of passion.
- here's the story from the San Diego Union-Tribune