I was told that I don't understand math or statistics, that I'm a "captured journalist," and that I belong in prison. One Arena fan hatched a plan to invite me to his house for a beer before disposing of my body in a nearby lagoon; another wants me to die of AIDS and wishes my dog would be run over by a car. Yet another "Areniac" expressed hope that I buy Vivus' (VVUS) weight-loss drug Qnexa for my wife so that she will give birth to a son with birth defects and a "statistically insignificant penis."
All in, it's been a fairly typical week for me!
The basis for this extreme ire pointed in my direction is my insistence that Arena's weight-loss drug lorcaserin is now potentially unsafe due to a six-fold numerical increase in the reported cases of valvulopathy, or heart valve disease, observed in a study of obese diabetic patients.
Add an increased risk of valvulopathy to a list of lorcaserin problems that already includes troubling rat cancer data and minimal efficacy and you have a drug that is on life support, if not dead altogether. The FDA rejected lorcaserin once already and now regulators have another reason to reject the drug again if and when Arena tries to resubmit it for approval.Arena boosters disagree, obviously, and from the comments listed above, they're not too happy with me for saying so publicly. The truth hurts. Arena shareholders have lost a lot of money with the stock's plunge. They're angry, frustrated, and incapable of taking responsibility for their own bad decisions. Instead, they concoct lame conspiracy theories to rationalize lorcaserin's troubles and lash out at people like me. The truth that Arena shareholders can't accept is that the risk of valvulopathy was never ruled out definitively in the previous two, large phase III studies of lorcaserin. In fact, a statistical analysis of the studies conducted by FDA and presented during the September advisory panel meeting suggested that lorcaserin exceeded the acceptable safety margin for valvulopathy by a small amount. I write for a living but I do know something about math, so I understand that the valvulopathy signal in the diabetes study was not statistically significant and comes from just a handful of patients. And yes, the placebo rate of valvulopathy in these patients might be artificially low.
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