It is clearly a slap in the face to all the patients and their families to have Pfizer uniformly denying the many problems with this new “novel drug”. It is conclusive that this is a first of its kind medication, so naturally problems could arise. What is deplorable is how Pfizer somehow makes it seem as if the patient is the one with the problems, not the drug.

That is a commonplace defense when a drug goes wrong, but in the case of Chantix a better defense can not be found by Pfizer.

As Chantix will one day have to stand alone, I hope that some of the back-pedaling and name calling stops by Pfizer as they begin to work with others to help find a solution to this medication nightmare. Too many lives are at risk to have a company be so underhanded and flippant about the most reported AEs to the FDA. Pfizer was aware of the alarming rise in number of AEs being reported to the FDA, but chose in Pfizer fashion to point fingers and make accusations when the truth was told by others.

The defense for Pfizer is no longer plausibly to even the die hard-pharma drs. I think this wretched defense of blaming the patients is reserved for the criminal. It is past time for action.

Thank you for your insightful responses, and sharing links to your publications. I reviewed them and appreciate the discussion of the data limitations. And let me state that I agree that these data suggest further safety studies are warranted.

With that being said, I continue to find the use of these data (which I will infer are the AERS data since that question was not directly answered) for anything other than rationale for further study troubling. The severe limitations of these data, including no means for establishing causality, should preclude any scientist from drawing conclusions or making public health recommendations.

Lastly, all of your points (1-4) are in direct conflict with the caveats published by the FDA that I quoted in my original post: “Comparisons between drugs cannot be made from these data.” All of your points are comparative and should not be made.

Ed, thank you for facilitating this candid exchange. I would suggest exploring the impact that quasi-scientific publications such as those discussed here have had on public policy decisions. It appears to be an excellent example of “flawed data in, spurious conclusions out”. I’m sure the public would be interested.

Thank you again.

Best Regards,
Tom

When our monitoring program detected a large number of reports for Chantix, it was important to define “large number” meant. So we provided several comparisons to help regulators, doctors and patients understand the magnitude of what we were seeing. We reported:

1. More reported serious or fatal adverse events for Chantix than for any other prescription drug for two calendar quarters.

2. More reported serious or fatal adverse events for Chantix than for the 10 most frequently prescribed brand name drugs combined in 2008 Q1.

3. More reported serious or fatal adverse events than for alternative treatments for smoking cessation.

4. The typical (or median) number of reports of serious injury or death for a monitored prescription drug was 6 reports a quarter. In 2008 Q1 Chantix accounted for 1001 reported cases the United States.

This is a strong signal of a potential safety problem any way you look at the data. This does not tell us how “frequently” injury is occurring in the patient population. But people would say that the principal tool for post market surveillance of approved drugs has detected a safety problem worth priority attention.

For our frank and detailed discussion of the strengths and weaknesses of adverse event data please see the full text of our two reports:

http://www.ismp.org/docs/vareniclineStudy.asp
http://www.ismp.org/QuarterWatch/2008Q1.pdf

I’ve reached out twice and await a reply, either directly or, perhaps, on the site itself. So….

Regards
ed

Thanks for following up on my suggestion. Any response?

Best,
Tom

Thanks for the note and I’ve written Cohen to ask him to reply. Hopefully, something will come back.

Regards
ed

The Read Me file that comes with the AERS data specifically state: “Accumulated reports cannot be used to calculate incidence (occurrence
rates) or to estimate drug risk”, all of which is implied by Mr. Cohen. Secondly, it states that, “Comparisons between drugs cannot be
made from these data.” Clearly variability in drug risks are being insinuated by these reports. I urge you to investigate these points at http://www.fda.gov/cder/aers/default.htm, and conduct a second interview with Mr. Cohen.