Yesterday the FDA asked Novartis to remove a drug, Zelnorm, from the market. Novartis, the makers of Zelnorm complied. I have helped scores of people with this agent and with no real harm to any!
Well, a look back at the original data showed 7 adverse cardiovascular events out of roughly 11,000 who took drug and 1 adverse cardiovascular event out of 7,000 who took placebo. Therefore, since this is statistically significant--since the trial lawyers made such a harang out of other minimal risks, no one will go out on a limb even a bit. Zelnorm is gone--at least for now and probably only to be rereleased with a major ordeal to prescribe. Asprin is not as safe as Zelnorm, cars are certainly not as safe as Zelnorm but Zelnorm represented by a single identifiable plaintiff must go!
Folks, the incidence of cardiovascular bad events with Zelnorm is historically what would be expected. The placebo arm had an unexpectedly low incidence of badness. What this really proves as much as Zelnorm is harmful is that the sugar pill used as a placebo is beneficial in preventing cardiac events. This is a meaningless statical aberation.
I now will receive countless call from people who were ALL better who are again miserable. These people are suffering and will have to suffer again all becuase of some statistical noise and the abuses of some within our legal community. Folks, there is no real good substitute for Zelnorm.
Thanks for letting me vent!
Well, a look back at the original data showed 7 adverse cardiovascular events out of roughly 11,000 who took drug and 1 adverse cardiovascular event out of 7,000 who took placebo. Therefore, since this is statistically significant--since the trial lawyers made such a harang out of other minimal risks, no one will go out on a limb even a bit. Zelnorm is gone--at least for now and probably only to be rereleased with a major ordeal to prescribe. Asprin is not as safe as Zelnorm, cars are certainly not as safe as Zelnorm but Zelnorm represented by a single identifiable plaintiff must go!
Folks, the incidence of cardiovascular bad events with Zelnorm is historically what would be expected. The placebo arm had an unexpectedly low incidence of badness. What this really proves as much as Zelnorm is harmful is that the sugar pill used as a placebo is beneficial in preventing cardiac events. This is a meaningless statical aberation.
I now will receive countless call from people who were ALL better who are again miserable. These people are suffering and will have to suffer again all becuase of some statistical noise and the abuses of some within our legal community. Folks, there is no real good substitute for Zelnorm.
Thanks for letting me vent!