October 16th, 2014, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
My name is Dr. Laurén Doamekpor, and today I am speaking on behalf of many members of the Patient, Consumer, and Public Health Coalition. The Coalition includes large and small nonprofit organizations across the country that are united to ensure that medical treatments are safe and effective, and to enhance the scientific and public health focus of the FDA. The coalition does not have paid staff and does not accept funding from any outside sources, such as pharmaceutical companies or law firms, so I have no conflicts of interest.
Smoking kills thousands of Americans, and we agree that Chantix should be an available option for smokers who want to quit.
Last week, these 5 major national organizations filed a Citizens Petition for a stronger Black Box Warning for Chantix:
- Consumer Reports
- Institute for Safe Medication Practices
- National Center for Health Research
- National Physicians Alliance
- Public Citizen
We agree with those organizations that the black box warning is essential and should be improved, not weakened.
The sponsor identified 5 observational studies and 2 meta-analysis studies showing no statistically significant differences in various psychiatric adverse effects between Chantix and other smoking cessation drugs. The sponsor suggests that this evidence supports the removal of the boxed warning for serious psychiatric adverse events.
You need to consider whether the meta-analysis and observational data that the sponsor has identified prove that the black box warning is not needed.
- The studies in the meta analysis share the same methodological flaws. They do not assess all 4 serious psychiatric side effects that have been reported for Chantix: suicidal behavior, aggression/violence, psychosis, and depression
- And the value of a meta analysis depends on what studies are included. But no justification was given for the inclusion and exclusion criteria used in the 2 meta-analysis studies.
- One of the meta-analysis studies included only 5 studies
- The studies did not assess hostility/aggression, depression or psychosis.
It included 2 studies of smokers who were previously diagnosed with schizophrenia or depression in other words, patients who already were suffering from delusions, uncontrollable thoughts, or depression BEFORE taking Chantix were studied to see if Chantix caused those psychiatric symptoms. Those 2 studies should have been excluded from the meta-analysis, since a meta-analysis is intended to combine studies that are similar in terms of study design and outcome measures.
That left only 3 other studies of smokers who were not previously diagnosed with mental illness, and yet there are at least 14 other studies that should have been considered for the meta analysis.
The observational studies also had fatal flaws in study design.
- They didn’t analyze all psychiatric side effects. They only analyzed psychiatric hospitalizations, even though 82% of the 4 serious psychiatric side effects seen in adverse event data did not result in hospitalization.
- The British Medical Records Study only examined suicidal behaviors and depression – but nearly 47% of the study population had present or previous use of antidepressant medication. It was obviously not a representative sample.
- The Danish Medical Records study only captured hospitalization and ER visits for the first 30 days after Chantix use was initiated.
In conclusion, because of the very serious flaws of these studies, they can not prove that Chantix does or does not increase psychiatric side effects.
From a scientific and public health standpoint, these studies do not provide an assurance of safety that patients need and deserve.
We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label.