Martina Flammer, Pfizer’s senior medical director, says people with mental illness should be able to take Chantix. “There is no indication that there is any reason why Chantix should not be taken in this population,” she said.

David Gonzales, co-director of Oregon Health & Science University’s Smoking Cessation Center, who led some key Chantix studies. He addressed a particular area of controversy - the trials didn’t include smokers with psychiatric illnesses, which means, as he put it, “the patients in the trials are not terribly reflective of the population of smokers.”

First, my apologies for a very belated reply. A couple of technological mishaps and the crush of news conspired to prevent me from posting an answer to your question on Friday afternoon. But I confess I also waited initially while mulling over my response.

So, I think the attempt was a genuine effort by Pfizer to explain its side of the story, which included some spin, but that’s human nature and, therefore, not at all surprising. That’s to be expected. To their credit, the Pfizer folks put three people with knowledge and responsibility in front of us to review material and answer questions. And there was enough time for both.

However, one problem, in my view, was that the presentation included slides, but these weren’t made available, during or after the session. So I was at a disadvantage, because I didn’t have the same material to review as the explanations were given. As a result, I felt like I was attending a tutorial and blinded by science just a bit. If one is going to invite people in for a presentation, corresponding materials should be distributed at the outset. This much of the affair was one-sided and, in its way, unhelpful.

Was it a waste of time? No, it’s almost always worthwhile to meet and listen. I’m not sure this held any great revelations, though. And I think Pfizer could and should have done this earlier, because the crisis was clearly brewing months ago. But it was better than nothing.

Finally, I didn’t come away with any great insights into the company. I’ve been doing this a long time and crisis pr is crisis pr. Insights are provided when key decisionmakers are put out there to discuss the normal course of business. In general, though, pharma execs are rarely available or accessible in that way, except to analysts, fund managers and other investors. This was a one-off in response to a crisis, so its not going to offer much more than a glimpse of some worried managers.

Hope this helps,
ed

Regards,

John

John R. Polito
john@whyquit.com

I have all the same questions you do. As you know, I sell an epilepsy medication, and pregnancy data are really hard to come by. The problem with registries here is that doctors can’t register the patient; the patient must do so, and many don’t take the time.

I believe the same problems arise with AE reporting. The physician makes the report, but the FDA is limited in its ability to follow up–I THINK, I’m not 100% sure. There is no back and forth between the FDA and the physician to determine causality. They do collect as much data as possible–concommitant meds, patient age, sex, height, weight, but I don’t think they have access to patient records. Thus, they don’t know if a patient who has an MI, for instance, had a history of cardiovascular disease. They only know if he/she is currently taking heart meds–or if the doctor tells them he had a previous event. Then, there is no way to put that information in the AE report, so the public perusing the reports doesn’t have any context.

I would think that somehow a unique patient identifier could be given when a report is made–the problem is that identifier can’t be communicated to all treating officials and the patient. Thus, a PC could make a report and then a specialist could make a report, but the FDA has no way of knowing it is the same patient.

The other issue is that of getting context–like I said, the AE report doesn’t indicate whether the patient has on-going disease, nor does it indicate severity or causality. That is why I was laughing at the “arthropod sting” reports. And all the GI distress and abnormal dreams. When the AE report is 90% noise like that, it is disingenuous to describe it as “1,000 serious events.”

Another issue is one you pinpointed–we don’t have a universal data base. There are several groups working on such a database (Google, for one), but nothing is in place yet. Even then, HIPAA strictly limits access. Without patient permission, one physician treating a patient cannot even request records from another treating physician.

Finally, the level of sophistication with physicians is not always what you would expect. Physicians aren’t always familiar with side effects, nor do they exercise discrimination in attributing SEs to meds. Thus, the assumption that just because a physician made the AE report it must be serious is not a valid one.

As for reporting fraudulent information–I don’t know how many reports are actually fraudulent, although that would be a great way to sabotage a drug (one of those groups could make all sorts of reports), but it is virtually impossible to verify the reports because of HIPAA.

HIPAA bears out my favorite law: the Law of Unintended Consequences.

Question - Is it necessary to provide patient identifiers to get good data? The AEs I’ve read still provide what seems to me to be valuable data without indicating names. Can’t some number index be used that will provide a link for follow-up but keep identity confidential? Could some official group be sworn in as a keeper of the records? Could all the data be codified for compiling?
Aren’t all medical records kept in some kind of database anyway? What about an extension of this system? Could some penalty be imposed for reporting fraudulent medical information? Like insurance fraud.
Could hospitals be charged with followup of any AE, each having charge for a territory in their respective local?

Sorry, just groping in the dark now.

You are right about the AE reporting system–but I think I’ve pointed out before that HIPAA makes it difficult to have good reporting. The docs can’t provide patient identifiers. And as a closet libertarian, I don’t think the government should force us to do much of anything.

Lisa,
I never said my mother died in childbirth. I have noted before that she is alive and well, taking Zoloft, for which I was roundly criticized. If that was your attempt to be funny, I fail to see the humor in it.

Ed! I was astonished to see the “new look!” Think I like it, although I don’t have time right now to navigate around it and check it all out. Going to see yet another movie–Adam Sandler this time.

I don’t think anyone would argue that without the development, research, and deliverance of of wonderful drugs that many lives would be saved. That is not the topic.

I think if one is a rep they can not get past someone seemingly dishing on pharma.

My point being - Adverse Event Reporting is vital. The system is less reliable than it should/could be.
In other words the current system might over indicate that black box warnings be used or it might underindicate that there is a real problem with a drug or device.

What can be done to establish a system that we can rely on to properly direct us on a path that is effective for both pharmaceutical companies and public safety?

The issue of signal generation is very complex. It is one important tool to be used in monitoring drug use in the real world. But it is not clean data as many on this site have noted. It must be taken in context of many other variables, few of which are definitive.

Some asked why were patients with psychiatric conditions excluded from the early studies? Valid point, but working with as few variables as possible in an approval study is one of the weak points of the FDA requirements. This is not the place to regenerate a debate on this long standing approach to drug approvals. For Chantex it now may make good sense, from a scientific standpoint, to go in and do a safety-efficacy study in smokers with psychiatric disorders but from an ethical and litigation perspective I don’t know if it would pass an IRB.

In the mean time, folks, what should we do?

Over caution or even put a black-box on yet another very useful product to help curtail utilization of a medication to curtail one of the top killers of people? With today’s litigious society this is a real concern. If you think I am over dramatizing this risk take a relook at the story on that old-as-dirt drug, phenergan.

There is ALWAYS going to be a risk with prescription drugs. There will NEVER be a completely safe product with ALL aspects known. That is why, folks, they are and must be prescribed by a leaned-intermediary. As a society we could take the view of zero-tolerance for side effects (as some at ISMP may advocate for) but this would simply not be realistic and most everything, including aspirin, would be considered dangerous. Or we as a society could insist that learned-intermediaries pay closer attention to how to properly use medications. The formal training in pharmacology and therapeutics is woefully under whelmed in most medical, dental, nursing and PA schools and training programs. Yet, these folks prescribe. (I know that I will be heavily criticized for this view – but I believe it to be true). Ironically, the professional group who receives the most formal training in this area, pharmacists, can only prescribe in limited circumstances.