private coziness…

Posted on Thursday 25 September 2014

Pharmalot: WSJ
By Ed Silverman
September 24, 2014

In a boost to Pfizer, the FDA has updated labeling on its Chantix smoking-cessation pill to indicate the drug may not carry the risks of suicidal behavior, a controversial issue that prompted the agency to include a serious warning in the labeling in 2009. The changes are being made to reflect the results of various studies. One study involved a so-called meta-analysis of five studies involving nearly 2,000 patients that Pfizer says did not show an increase in suicide thoughts or actions among people who took Chantix compared with a placebo.

The drug maker also pointed to four observational studies of between 10,000 and 30,000 people that did not find differences in risk between Chantix and other nicotine treatments, although these had several limitations [most of the label changes appear on page 3]. The labeling change is welcome news for Pfizer, which hoped Chantix would become a blockbuster but has instead encountered a marketing challenge. Shortly after Chantix was approved in 2006, the drug was increasingly linked in news reports of acts of violence or suicide. The FDA issued successive alerts, the Federal Aviation Administration banned usage by pilots and air traffic controllers, and the Departments of Defense and Transportation restricted use in sensitive occupations. Meanwhile, Chantix sales slid to $648 million last year from $846 million in 2008. And Pfizer settled hundreds of lawsuits last year by people who claim Chantix caused them harm.

The labeling change, by the way, was made on September 19, but Pfizer had not publicly discussed the changes until today, when a watchdog group called the Institute for Safe Medicine Practices planned to release an analysis placing Chantix in an unflattering light and calling for the Black Box warning to be strengthened. The timing of the disclosure of the labeling change suggests that Pfizer sought to mitigate any negative publicity that may have ensued…

Pfizer would like the serious warning, which is known as a Black Box in regulatory parlance, removed, the Associated Press writes. A Pfizer spokesman writes us that the labeling change and upcoming meeting “both serve as a step forward in the process of accurately communicating the clinical and observational data” in relation to serious side effects referenced in the warnings section of the labeling.

Even though the Black Box remains unchanged, Pfizer may benefit to some degree, anyway. How so? The updated labeling now includes new information about the studies in the Warnings & Precaution section. As a practical matter, the Black Box is still front and center, but new language may soften the blow, at least if enough physicians interpret the new information as Pfizer would like. We asked the FDA if the Black Box may be removed and will update you with any reply.
    [UPDATE: Thomas Moore, a senior scientist at ISMP, contends the labeling may not help Pfizer very much. "The new studies added to the label provide little new insight into the psychiatric side effects of Chantix. The meta-analysis of suicidal behaviors included only a few of the many clinical studies, was much too small to detect these rare but catastrophic events, and was not published or peer reviewed.  The observational studies had even more limitations. Neither the observational studies nor the meta analysis included the full range of psychiatric side effects reported."]

    Meanwhile, ISMP reviewed side effect reports filed with FDA and found that Chantix accounted for more cases of suicide, self-injury or homicidal thoughts than any other therapeutic drug between 2007 and the third quarter of 2013. Moreover, Chantix ranked first in both suicidal and self-injurious thoughts as well as homicidal thoughts, and these reports outnumbered those for any other drug by more than three times. Moore says there is still more evidence that Chantix causes psychiatric side effects. And so the watchdog group plans to ask the FDA to further strengthen the Black Box warning and widen the restrictions on Chantix use to still other occupations. He declined to name those occupations…

    There were limitations on some Pfizer findings, as well. The observational studies were conducted after widespread publicity about Chantix and suicidal or hostile behavior, which means patients with a history of psychiatric illness may have been prescribed an alternative treatment. And only reports that resulted in hospitalizations were included, suggesting other incidents were not noted. 

    [UPDATE: ISMP’s Moore writes us that "the study of psychiatric hospitalizations omitted 85% of the known psychiatric side effects and depended on diagnostic codes that had not been studied or validated."]

    [EDITOR’S NOTE: An earlier version of this story indicated all the observational studies were conducted by Pfizer].
I declare ongoing resentments against Pfizer on any number of grounds: the way Zoloft® was approved by the FDA was insider trading [see [zoloft: the approval III…]; their shameful clinical trial of Zoloft® in adolescents [Wagner et al][see tuning the quartet…]; financing Robert Gibbons’ recurrent attacks on the various Black Box Warnings [see very monotonous…]; promoting Gabapentin [Neurontin®] as a pain medication [E-mails suggest Pfizer tried to suppress study on drug]; but mostly for their ads that put the phrase "chemical imbalance" into the public register.

Pfizer has run into black box warnings with all three drugs [Zoloft®, Neurontin®, and Chantix®] and spent a mint trying to counter them [very monotonous…way past time…]. They seem to feel picked on to have 3/3 drugs under warning. Another more reasonable interpretation is that they aren’t very good at looking at their data or are given to sleight of hand in reporting. All of the studies are industry funded and are based on population studies. But the part that has me writing is that they seem to have a habit of operating privately with the FDA. They sure did that getting approval for Zoloft® in the first place [zoloft: the approval III…]. Now, here they go again with Chantix®:
The labeling change, by the way, was made on September 19, but Pfizer had not publicly discussed the changes until today, when a watchdog group called the Institute for Safe Medicine Practices planned to release an analysis placing Chantix in an unflattering light and calling for the Black Box warning to be strengthened. The timing of the disclosure of the labeling change suggests that Pfizer sought to mitigate any negative publicity that may have ensued…
Private coziness with the FDA just isn’t going to do, even if they do bring in $50 B/year. And for what it’s worth, my anecdotal experience with Chantix® has been negative – no successes and complaints about agitation in most cases. I decided to stop prescribing it fairly early. 
    September 25, 2014 | 2:00 PM

    A friend once tried Wellbutrin for smoking cessation and immediately felt very strange sensations that were very disturbing to him, which caused him to drop the Wellbutrin with extreme prejudice.

    This person probably never felt anything that would be described as a symptom of psychiatric disorder in his life. Years later, he was still talking about his horrible experience with Wellbutrin.

    The effect he described sounded like depersonalization.

    Steve Lucas
    September 25, 2014 | 3:33 PM

    A pharmacist friend tried Chantrx and dropped it in a hot minute describing how he was going to litteraly kill someone just for saying hello. He had no good things to say about this drug.

    Steve Lucas

    September 26, 2014 | 9:41 AM

    I have had several patients request a trial of Chantix. After lengthy discussions about side effects a few of them persisted in wanting to try it (some because of good reports from friends). I have not seen it be terribly successful, and I have had a few whose mood symptoms worsened markedly. I can’t say I’ve found it very useful so far.

    September 27, 2014 | 2:36 PM

    The effects of Welbutrin were extraordinary. I felt completely free from the spell of nicotine. I started taking it during the countdown to quit and was a couple of days from the final when I found myself completely indifferent to smoking— as if I never had. It was a profoundly calm and curious state.

    I got out a cigarette, looked at it, and smelled it. It might as well have just arrived from another planet. I lit it then watched the smoke rolling out of the tip , smell the odor of the burning tobacco and paper. I felt nothing. For nicotine addicts who haven’t quit for year or more, seeing someone else go through this process actually causes the same patterns in their own brains.

    Colors were brighter, edges crisper, and the calm I felt was so deep and unfaltering that it felt mystical.

    Then, with one of my tragic faults, I thought that I could finally be one of those people who can smoke occasionally and not be disturbed addiction.

    It broke the Wellbutrin spell and I couldn’t get it back. A couple of years later, after I got a computer, I ran across an article saying that Wellbutrin works on motivation and had no problem believing it.

    September 27, 2014 | 9:05 PM

    Is there a story out there about a pharmaceutical company that makes a psychotropic med which is without controversy, post introduction fall out, or simply not the company’s major money maker?

    Doubt it. So, what is the summary here whether it be Pfizer, Glaxo, Lilly, Merck, Abbott, Johnson & Johnson, Astra Zeneca, etc…

    Face it, they all have themselves as primary concern and agenda. And, the public continues to accept that drugs cure or “fix” them, so how many times do we do this dance before we just drop from exhaustion?

    The villains in this story are easily the Sinister 6, and that leaves four more after psychiatrists and big pharma. You all fill in the blanks for 3 thru 6.

    September 28, 2014 | 10:07 PM

    Has anyone seen this new science journal? It’s a soothing balm after a long day of trying to figure out what anyone is talking about.

    September 29, 2014 | 3:31 PM

    David Healy is at it again regarding RCTs and adverse effects:

    In the meantime, it seems he’s again being investigated by the NHS General Medical Council (GMC) for the usual reasons.

Sorry, the comment form is closed at this time.