James C. McAllister III, MS, FASHP
Pharmacy Times Editor, Health-Systems Pharmacy Section

Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.

On February 1, 2008, the FDA issued a public health advisory on varenicline (Chantix) alerting providers and patients to new safety warnings related to possible neuropsychiatric symptoms with the drug's use. In the same advisory, a physician director for the FDA validated varenicline's effectiveness while acknowledging its risks and the need for close monitoring of patients by health professionals. I suspected that the FDA would continue to monitor adverse event reports, encourage its manufacturer (Pfizer) to continue to study the drug, and possibly require a black box warning in the product literature. This strategy is typical in similar situations and appropriately encourages physicians and pharmacists to collaborate with the patient to ensure its safety and efficacy.

I was stunned by the May 23, 2008, Federal Aviation Administration (FAA) decision to order pilots and air traffic controllers to stop taking varenicline immediately. The FAA decision appears to have been made in response to many articles published the day before in the lay press, which cited a report by the Institute for Safe Medication Practices (ISMP). Researchers at ISMP and Wake Forest University had reviewed 988 adverse event reports related to varenicline use that were turned in to the FDA in the fourth quarter of 2007. The researchers concluded that the data "provide a strong signal that the risks of varenicline therapy have been underestimated and show a wide spectrum of serious injuries are being reported in large numbers," but acknowledged that its manufacturer and the FDA should take further steps, including conducting more clinical trials. The researchers also cautioned that the data do not definitively prove that the drug caused the symptoms reported.

The FAA decision, in my opinion, was not made based on scientific evidence, but rather in response to sensationalized media reports of the findings of ISMP reviewers. Because pilots risk the loss of their livelihood if they are noncompliant with the FAA order, however, such decisions are quite effective in changing pilot and air traffic controller behavior.

I understand that public awareness about medication-related adverse events is at an all-time high (which is a good thing), and that organizations—including government agencies—feel compelled to promote patient safety to avoid public relations nightmares if an adverse event occurs. Airline pilots and controllers have responsibilities for the safety of the flying public. If varenicline consumed by pilots and controllers puts passengers at risk, why shouldn't other workers, who might potentially also put their customers at risk, be banned from consumption as well? Should school bus drivers, railroad engineers, and truck drivers be made to stop taking varenicline? What about pharmacists who check hundreds of medication orders every day? Should their employers insist that they not be taking medications that have neuropsychiatric side effects? What about surgeons, nurses, or police officers?

We talk about the importance of evidence-based medicine and the value proposition of collaborative providers effectively managing individualized therapy. The review of "possible" adverse event reports is a long way from a well-designed clinical trial. Decisions to restrict a drug's use in groups of individuals should be made based on review of scientific literature by qualified experts, as has been done by the FDA for decades. Otherwise, the decision to prescribe and follow a drug therapy regimen should be made collaboratively by providers and patients following a risk–benefit determination. To do otherwise threatens the pursuit of optimal drug therapy outcomes for individualized care.

This decision has Health Insurance Portability and Accountability Act implications that I have not even described and is equally worrisome from a precedential perspective. I think that this event threatens the provider–patient relationship and should be carefully monitored to ensure that the erosion of provider roles and the shift of drug therapy oversight to employers do not proliferate. What do you think?