Last week, Pfizer mounted an aggressive defense of Chantix after the pill was linked to
988 serious injuries and a host of side effects, including heart irregularities, seizures, severe skin reactions, acute myocardial infarction, aggression and suicide. Newspaper ads were run and a media 'roundtable' was scheduled with Joe Feczko, Pfizer's chief medical officer, among others.But across the world in India, smokers may not know about the problems from reading the official web site for Champix, the name for the pill in many other markets, unless they register as a Champs club member. In conjunction with the World No Tobacco Day this past Saturday, Pfizer launched the site, which implores smokers to sign up for its club.
However, none of the side effects that have caused such a stir are readily visible on the site, unless personal info is provided, including name, address, age, phone number, e-mail address, the name of the doctor who provided a prescription and the date the prescription was written. And the disclaimer features language that protects Pfizer without mentioning the club member's privacy.
Once you register, then you can find info about safety, side effects and warnings not to drive or operate machinery while using the pill. However, an outdated page entitled ''Patient Information' doesn't list any neuropsychiatric side effect. By contrast, the primary Chantix site - type in the name on Google to get to this one - has safety info clearly marked on the first page.
A Pfizer spokesman says the site is going to be updated, but was unable to explain why the site requires registering with personal info before risks are visible or whether that requirement will remain in place.
We confess that we have no idea how many specialized web sites for prescription-drug products are designed the same way. And we understand that standards, expectations and laws differ among countries. But safety info should be as readily available as benefits - and certainly without having to first divulge personal info. That's called putting patients first, a goal pharma is always claiming. Pfizer should join that club and change its web site in India.






16 Comments
The very small number of serious side effects is most likely due to nicotine withdrawal. If you are having serious problems on chantix stop taking it and go back to smoking… it's the best antidote. I would guess that problems may arise in people who have a higher degree of dependency on nicotine or have some under-LYING psychiatric disease beyond addiction. It's likely that most psychiatric drugs will have side effects that were unanticipated in a small percentage of patients. That’s what a small number of people on this site talk a great deal about..
I expect the reason that the Indian Champs Club doesn't provide any safety information about Champix is that it doesn't provide any information about Champix at all.
Because direct-to-consumer promotion of prescription medications is illegal everywhere in the world except the US and New Zealand, online information about prescription drugs can only be provided to patients already on therapy with that drug.
The key information required to get access to this information in India is not the "...name, address, age, phone number, [and] e-mail address..." but "...the name of the doctor who provided a prescription and the date the prescription was written..." which identifies them as already on therapy and thus eligible to receive this information.
Under new regulations proposed by the European Commission, pharma manufacturers would at least be able to post this kind of information contained in the product labeling on the Web. Industry, not unexpectedly, would like to be able to provide a wider range of "educational" information. But industry critics object to providing even this minimal level of information.
Thus the kind of opacity to important safety information that the Indian Champs Club site highlights is actually the result of Pfizer's compliance with national legal restrictions...irrespective of whether they might wish to conceal or minimize negative safety information.
...and just a thought -- wouldn't the credibility of people's comments here be enhanced if they used their actual names, rather than pseudonyms?
It became the publics job to police these drugs since when?
Since agencies employed to police drugs failed to do their work effectively?
Amen! Could it also be that the companys are withholding data?
Surely that couldn't possibly be the case? Drug companies witholding data? Whoever heard of such a thing :)
Tobacco companies are up front about the dangers of smoking..How has that helped?
Could patients be lying so they can glom on to a class action? Whoever heard of such a thing ;)
BTW is the consensus on this site that tobacco is safer than chantix?
When tobacco companies eventually became upfront about the dangers of smoking it helped get a great number of smokers off tobacco.
I expect there will always be a small proportion of people who 'glom on' to a class action, just nowhere near as many as there are in the drug industry and others who benefit from it who are happy to 'glom on' to the money that comes from denying there are risks or for trying to cover scientific misconduct by blaming the results on patients.
Is there a consensus on this site whether tobacco is safer than Chantix? If neither are 'safe', does that mean that the risks of the pharmaceutical alternative are acceptable?
The reason why I believe it would be a SMALL proportion of people who would try gloming (?) on to a lawsuit is this:
"Our responsibility - which we take very seriously - is to discourage litigation in all but the most egregious cases. Involving yourself in a lawsuit with defendants with unlimited resources is a mammoth undertaking, sapping most of your emotional, spiritual and economic resources. In the face of tragedy, these resources are already seriously depleted. Our experience is that the pharmaceutical companies will do virtually anything to protect their multibillion dollar drugs. When you sue them, their lawyers will open virtually every closet door in your life and microscopically examine every skeleton. Every aspect of your life - a spouse's drinking problem, a daughters abortion, problems at work - will be blamed for what their drug might have caused. It's not a bit overstating the rigors of litigation to tell you that the process itself might just be worse than the tragedy that caused the filing of the claim."
From http://www.socialaudit.org.uk/5016-112.htm
What I want to know is this: Why ain't that Pfizer "spokesman" as smart and knowledgeable about this as is Bruce Grant!
With all due respect to my corporate communications buddies -- most of whom came from the journalism backgrounds -- it's about time that you were trained a bit more in the laws and regulations governing pharma.
But perhaps the job of corporate spokespeople is not really to answer questions, but to deflect and dodge 'em!
Hi Bruce,
Thanks. That's a very good point. And I appreciate that you wrote in. I would only add that the site isn't entirely educational, at least in my mind, in that it's not the Quit Smoking Club, it's called Champix Club. And the product, of course, is clearly promoted.
The overriding benefit is imputed, as well, in that the med is clearly the focus of the site, which is about quitting smoking. So in that regard, I view that as a benefit and, as a result, the site isn't particularly neutral - to me.
As a result, Pfizer may be complying with local law but, at the same time, promoting its product directly to consumers. Granted, there is no study data on the portion of the site that is visible without registration.
So Pfizer may argue product attributes aren't promoted, but I would disagree in that, again, product benefits are. It's a very fine line that doesn't do the patient sufficient justice. I agree that this speaks to the broader issue, though, and requires careful balancing.
I also remain curious about the wide net cast on the registration form, what becomes of that additional personal data and the lack of privacy protection stipulated.
In any event, I appreciate the note.
Cheers ed
I won't argue with the proposition that Pfizer did not welcome any "spontaneous" mental association with Champix...but the name of the site was *Champs* Club, not Champix Club, and it promoted a *program* for people on a *certain prescription medication.* They sailed just about as close to the wind as they could have without violating the law outright, but it was (not only in my opinion but in that of their in-house regulatory folks) compliant with Indian law.
It is the part of "sailed just as close to the wind as they could have without violating the law outright" that has alllowed this neurotransmitter dopamine chemical to be handed out as a "great miracle drug" that "doesn't cause any harm except nicotine withdrawals".
Pfizer is welcome to use any and all of their test subjects who were in the Chantix trials for personal info, but not the consumers who are already being scammed by their product!
Privacy! Privacy! Privacy!
Hi Bruce,
You're right - it's Champs club, a clever play on Champix and so close to Champix that I wrote it as Champix in my last reply to you. That was inadvertent, although it does underscore that its an effort to get people to think about Champix. Also, I didn't mean to suggest Pfizer violated Indian law, although the company may well have for all I know. Either way, I simply believe this should have been handled differently. Sorry for the late reply; I fell asleep watching those primary returns.
Regards ed
How about a Chumps Club!?