"This website is the online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them needed medicines," the site reads. "Our goal is to convince the Administration to reverse a recent decision which would effectively deny senior citizen cancer patients' coverage and access to drugs prescribed by their doctors to combat anemia and reduce transfusions due to strong chemotherapy." And so readers were instructed on ways of contacting their elected reps and writing testimonials about the medications.
But there may have been a problem. As pointed out in the latest edition of The Cancer Letter (subscription required), the site appeared to be encouraging off-label use of the meds. In testimonials, the newsletter notes, patients and their family members wrote that the drugs alleviated symptoms of anemia, improved quality of life and were essential for survival. But the drugs were approved only as a substitute for blood transfusions in solid tumors.
And so faster than you can say 'Get me a scalpel,' the site disappeared. (But we located it anyway, so you can see for yourself). "The question is Amgenâ€™s control over what went on there,â€ an unnamed former FDA attorney told the newsletter. "Unless Amgen gave a blind grant to somebody and had no idea that this was going to happen, they have potential liability." The site was run by Direct Impact, a unit of Burston-Marstellar, the public relations firm.
An Amgen spokeswoman says the site was removed for two reasons - Amgen is petitioning CMS and wants to see how that plays out, and because the FDA this week requested new warnings on the drug labeling, although the newsletter noted the FDA press release appeared on the site. "Amgen is evaluating the website's continued use and its role in helping advocates participate in the ongoing political and legislative decision-making debate," she wrote Pharmalot. "While Amgen conducts this review and evaluation, we have chosen to leave the website under construction pending any updates."
So do you think the site will come back?