Will Nexium Become Another Avandia?
4 CommentsBy Ed Silverman // August 9th, 2007 // 3:38 pm
Paul Seligman, the associate director for safety policy and communication in the FDA’s Center for Drug Evaluation and Research, doesn’t seem to think so. But he was careful this afternoon when explaining how the agency approached a tricky problem it was presented on May 29 - what to do with a pair of long-term studies raising questions about a potential heart risk with two widely used AstraZeneca ulcer meds - Nexium and Prilosec. In fact, the drugmaker continued providing data through July 12, and again on July 25.
So far, the agency believes the drugs remain safe, and that doctors and patients shouldn’t do anything different. The FDA actually today issued a public notice with that message, the first time the agency has attempted to communicate evolving safety issues in such an open manner. However, this is only a preliminary finding; the FDA won’t complete its analysis for three months.
So in the wake of the safety controversy, most recently epitomized by Avandia, why not schedule a full-blown advisory committee meeting, and not just issue a public notice that suggests nothing has changed but could still set off a panic? Seligman acknowledged the outcome is unclear. FDA officials, however, are obviously mindful that it wouldn’t look good to sit on confounding data for a year - which is what happened with Avandia (as Matthew Herper at Forbes notes).
“It’s hard to know how this process will play out,” Seligman told journalists on a teleconference call. “This is something of a moving target. But we were discussing at what point we should say something, and what we should say. There was a lot going on, internally, during June and July about how we should communicate…We always try to make our communications as factual and balanced as possible, and neutral in tone, to reflect what we know…Our hope is that our words speak for themselves.”
By the way, the FDA’s primary focus is Nexium and Prilosec, the agency is interested in data extending to the entire class of proton pump inhibitors, which would include Wyeth’s Protonix and TAP’s Prevacid. To read AstraZeneca’s statement in response to this episode, please click here.
Lisa Van Syckel
FDA is incapable of communicating with the American Public.It has been a year since the investigation of non ditribution of life saving medication guides.Its been almost two months since the FDA held Hearings on Med Guides,and still no remedy.
There has been much hoopla in regards to Vioxx….
At least this drug is off the market.
While drugs like:
Paxil and Effexor are still being prescribed to children as young as 12 months.These medications carry a Black Box warning and was determined by FDA,and the PDAC, that not only do these meds cause violence and suicide,there is no efficacy.Children and adolescents are still dying.
Wasnt it the FDA heads that muzzled Dr. Mosholder in February 2004!…..
Hank
This is an interesting case. For _most_ people, acid reflux is not a serious problem. As I understand the data, even the correlation between reflux and Barrett’s is unclear, as well as esophageal cancer. When Nexium ads claim “healing,” they mean erosive esophagitis,i.e., irritation.
But a zillion people rely on these meds. I think Nexium is number 2 or 3 “blockbuster” after Lipitor. And, indeed, the data appear to be quite ambiguous at this point, at least based on what we’ve heard.
The question is: Do we trust what we’ve heard?
Mark
How do they manage to get doctors to prescribe this crap with Prilosec is available over the counter and generically? Do Doctors want their patients to spend more for the same drugs? They can’t be dumb enough not to know they’re essentially the same.
Melody
Mark, you state: They can’t be dumb enough not to know they’re essentially the same.
I believe there are a lot of smart doctors . . . but yes, there are some truly dumb ones. (How did they EVER get through med school becomes a compelling question.) Years ago, hubby’s doctor assured him that rDNA insulin–just like the human body makes–is better than natural animal insulin (just like God, or Mother Nature, makes). After almost two decades on the market, I would ask why diabetic complications have not decreased, why diabetic longevity has not increased, and why sudden death/dead-in-bed have increased?
Some doctors, it appears, are more than willing to be educated by biased research or conflicted sales reps. Then, again, how do we define dumb? This same doctor continues to promote whatever is the latest and greatest offering of diabusinesses–but he’s wealthy . . . he has a “diabetic wing” of the hospital named for him . . . and he is the local diabetes “expert.” Sometimes DUMB pays very well.