Pfizer's controversial quit smoking pill varenicline has been marketed here in the U.S. since 2006 as Chantix, and as Champix in the rest of the world. A report released yesterday by the Institute for Safe Medication Practices (ISMP), a consumer medication safety watchdog, reveals that varenicline has "now triggered reports of more than 8500 serious injuries" to the U.S. Food and Drug Administration (FDA).
On April 1, 2008, the FDA released a video clip warning that Chantix use had been linked to "behavior changes, agitation, depressed mood, suicidal ideation and suicide." On July 1, 2009 the FDA required Pfizer to add the FDA's highest level of product warning alert - a black boxed warning label - advising patients and healthcare providers as to risks of hostility, agitation, depressed mood, and suicidal thoughts or actions (FDA podcast and press release).
According to the ISMP's January 27, 2011 report, "despite the safety measures enacted to date, an unacceptable toll continues of reported serious injuries associated with this drug."
"Varenicline (CHANTIX) continued to account for large numbers of reported serious psychiatric side effects," wrote the ISMP. "In the second quarter the drug was suspect in more possible cases of hostility-aggression, depression and psychosis than any other monitored drug."
The report notes that the FDA logged 378 serious Chantix adverse drug events during the 2nd quarter of 2010, which included "130 possible cases of
clinical depression, 112 possible cases of hostility aggression, and
70 cases of psychosis or losing touch with reality."
"Case reports of these serious side effects outstripped those from the most
powerful antipsychotic and antidepressant drugs which are used more directly in vulnerable patient populations with mental disorders,"
wrote the ISMP.
On a positive note, the ISMP report states that "we have seen possible improvement for one psychiatric side effect - suicidal and self injurious behavior. In the second quarter of 2010, the 45 possible cases of suicidal behaviors were fewer than the other categories and did not outnumber all other monitored drugs. This may reflect some benefit of the FDA warnings which focused primarily on this adverse effect."
Pfizer's army of paid consultants had argued that Chantix FDA adverse event reporting had likely been inflated by media publicity about violence and suicides among Chantix users. The ISMP report presents charts comparing the number of Chantix prescriptions written since 2008 to the number of serious adverse events reported. Contrary to such assertions, the data suggests that over this 2
½ year period "the flow of reported serious injuries has largely tracked the number of prescriptions dispensed."
UK Data Suggests Chantix Effectiveness Claims Vastly Overstated
On January 6, 2011, I documented how Stop Smoking Services data from England's National Health Service (NHS) suggests that Pfizer's initial clinical trials had vastly inflated Chantix's worth. While 4-week point prevalence quit smoking rates in Pfizer's Gonzales clinical trail (2006 JAMA) were approximately 48% for varenicline versus only 23% for placebo, 4-week NHS Stop Smoking Services rates were 60% for varenicline versus a whopping 49% for those quitting without using any medications.
This decline of varenicline's 4-week victory margin from 25 percentage points over placebo to just 11 percentage points over real-world non-medication quitters raises serious doubts as to whether Chantix would prevail long-term (6
months or one year) over real-world cold turkey quitters.
Keep in mind that at 4 weeks brain dopamine pathway receptors of NHS non-medication quitters had already re-sensitized, down-regulated receptor numbers and adjusted to natural stimulation, while varenicline users still had at least one more month of treatment prior to attempting to adjust to natural stimulation.
The FDA could have demanded a quick and inexpensive real-world quitting method survey to determine Chantix's relative worth as compared to other far less dangerous quitting methods. It has not.
The FDA also could have required Pfizer to conduct an over-the-pharmacy-counter study to determine Chantix's real-world quitting rate when used as a stand-alone quitting product without any formal counseling or support, how real-world quitters are use it. This would have allowed the FDA to tell smokers Chantix's actual worth when unaccompanied by the record 25
counseling /support sessions received by clinical trial participants
during drug approval studies.
Why is the pharmaceutical industry so afraid to pit smokers wanting to quit cold turkey against those wanting medications? Why isn't the FDA demanding such studies? Oddly, it's as if the FDA does not want to know whether or not quitting without Chantix is more effective long-term than quitting with it. But why?
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