In a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly’s drug approved for the treatment of Pulmonary Arterial Hypertension (PAH).
The patient videos present statements made by Adcirca users, “Traci” and “Carolyn” who make the following claims among others:
- “I can walk, and stairs don’t bother me [after Adcirca treatment] . . . . Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”
- “Exercising and stairs and heat used to bother me and it didn’t bother me anymore [after Adcirca treatment].”
- “Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,” said the FDA letter.
- “I could walk a block without stopping and having to take a deep breath [after taking Adcirca]. I don’t have to drag my oxygen tank with me as many places as I used to.”
- “I am exercising again . . . and I couldn’t exercise [before Adcirca], now I am walking on the treadmill. You know and I am walking along the beach, slowly I am beginning to do a lot more of the exercising that I used to be able to do”
First, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will greatly increase their walking time and distance (e.g., “from . . . five minutes . . . to one hour,” “spending all night at the mall”, “now I am walking on the treadmill,” and “walking along the beach”). These statements significantly exaggerate what was demonstrated in the clinical trials for Adcirca. As stated above, the placebo-adjusted mean change increase in 6-MWD was 33 meters. Thus, there is only data to support that study subjects can increase their walking distance by 33 meters in six minutes.
Does the FDA really believe that Traci and Carolyn are real patients? I don’t think so — FDA is careful to put their names in parantheses, ie, “Traci” and “Carolyn.” Maybe if Lilly and other drug companies used actual patient video testimonials, there would not be so many misleading statements.
When you try to access the videos of the Adcirca Web site, this is what you get: