Last February, the FDA issueda health advisory about the controversial smoking-cessation pill and abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. This followed months of headlines that raised questions about the drug's safety and subsequent reports have done the same thing, including a study last month by the Institute for Safe Medication Practices.
As the months wore by, Pfizer sales reps began mentioning the safety and side effects, particularly psychiatric side effects, less frequently, according to data from ImpactRx, a market research firm. As the chart indicates, details were more likely to mention the issues in February than in subsequent months. Approximately 200 docs provided info each month about their interactions with Pfizer reps about Chantix. Impact, by the way, describes these as 'verbatims.'
Here is an example of positive positioning mentioned by Pfizer reps to docs: "Chantix has very few side effects. Sometimes, there's vivid dreams and sometimes, there's nausea. It should be dosed for a full three months and, sometimes, even six months to make sure the patient stays tobacco free."
Meanwhile, as this other chart notes, physician prescribing has been declining, although that hardly comes as a surprise...
9 Comments
Ed,
You're amazing. Where did you get this stuff?
Hi John,
Sorry for the belated reply on the Chantix data. I thought I replied earlier, but obviously didn't do so. Anyway, as indicated, the data comes from ImpactRx, which tracks the efforts sales reps are making to win over docs and the kind of attention docs are giving sales reps. And since I was curious to learn more about the detailing, I thought to call Impact, which was kind enough to define the activity.
Hope this helps, ed
Thanks Ed. I just didn't expect them (ImpactRX) to turn over that data to anyone but the Company/manufacturer or Congress/FDA. But you're "the" Ed Silverman, so I should have known better.
Ed, I think it is useful to note that this pattern of a crescendo leading into a diminuendo when talking about a particular AE or group of AEs is the rule, not the exception. You talk and talk about it, and then there's not a whole lot left to say. (Actually, come to think of it, that can be the case with almost all of what drug reps have to say!:+)) I sold one drug that received a tremendous amount of negative press (thanks to the competition) as it launched. We talked about it--and then we didn't. The possible AE didn't go away; we just didn't have anything to add.
What I find disturbing are Pfizer consultants writing Internet blogs advising physicians and patients without disclosing that they are currently both paid Pfizer consultants and members of Pfizer's speakers' bureau. At least in face-to-face presentations the relationship is known and disclosed. Sadly, it will probably require new federal law if we want financial relationship transparency during prescription medication safety or effectiveness presentations.
http://pharmagossip.blogspot.com/2008/06/pfizer-chantix-hows-positive-pr-push.html
Looks like more trouble!
JRP,
Where is this blog you are referring to?
Atlex
John R. Polito, Here! here! As one can only see by the number of post per Chantix blogs that well, "Houston we have a problem".
No amount of roundtable discussions from Pfizer can turn this monster around. No amount of spin from reps(paid consultants or otherwise) can stop this Chantix story from imploding.
What do you think Atlex?
I don't think that the blogging posts tell us much; the spikes are highly correlated with media attention. Moreover, some of it is likely being orchestrated (trial attorneys, tobacco industry--take your pick). However, I would argue that the drug will end up as a marginal drug for a combination of reasons. First, are there neuropsychiatric AEs? Very likely, but they are probably not as common as the perception being developed. (Are there other serious AEs? Probably not.) Second, as a society, we tend to far overblow risks vs. benefits of most everything. Thus, the neuropsychiatric AEs will probably scare off most smokers, who, in reality, may not really want to quit. In the end, while the drug might some day be taken off the market, the more likely scenario is that it will become an occasionally used marginal product.
In the end, this is probably a pretty good drug (not a panacea for smoking) with a solidly positive risk vs. benefit ratio. But a series of events and the current state of the public's view of medication will doom the product.
Atlex