A Houston woman quit the smoking-cessation drug Chantix for a second time after reading a so-called early-communication letter issued by the Food and Drug Administration late last year. The letter warned that the drug could be linked to increases in suicidal thoughts.
Deborah DeRousse is now smoking again, according to a Wall Street Journal article that examines whether patients may be overwhelmed by the amount of information about drug safety they receive through the media, consumer watchdog groups, and the FDA.
According to the Journal, a Pfizer Inc. survey of 300 medical professionals in March found that 89% of respondents were at least somewhat concerned that patients might stop their medications if potentially negative safety information was released to the public too early.
"Consumers may forget about the benefits of a medication if they focus only on risk," wrote reporter Shirley S. Wang. "And the health consequences associated with stopping a medication, particularly for a chronic condition, may be far worse than the possibility of a side effect."
During the 2007-08 legislative session, CJAC opposed a bill that could have also increased liability for makers of prescription medicines while potentially decreasing patient access to appropriate medication. In response to Assembly Bill 2690 (Krekorian), drug companies might respond by giving consumers the highly technical and complex information that doctors receive.
The bill would have eliminated a long-held legal defense, the "learned intermediary doctrine," which requires companies to direct their warnings to physicians, who act as "learned intermediaries" between the drug company and the patients. The rule recognizes that a physician, not a manufacturer, is best suited to evaluate the risks and benefits of a particular drug for each individual patient.
Fortunately for consumers, the bill died May 29 on the Assembly floor without a vote.