I've been meaning to blog about this for some time.
Paul Goldberg of The Cancer Letter allowed the PRWatch.org website to post one of his columns about how the Amgen drug company seemed to try to circumvent regulations on off-label claims about drugs by inviting patient testimonials on a website called ProtectCancerPatients.org.
Goldberg wrote:
Posted by schwitz at January 30, 2008 08:18 AM | TrackBack
Though the Internet designation ".org" suggests that the site is operated by an advocacy group, the "privacy policy" section notes that "this site is owned and operated by Amgen Inc." and can be used for communications with the company.On the home page, the site is described as "online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them ... coverage for needed medicines."
"Amgen's mission is to serve patients, which is why we openly support the Protect Cancer Patients website," Kelley Davenport, an Amgen spokesman, said in an email. "The site educates cancer patients on Medicare and their caregivers about a Medicare policy that impacts cancer patients, so that their voices and concerns are heard by government policymakers.
"As evidenced by the personal testimonials on the site, the current Medicare policy will have a significant, direct impact to cancer patients on chemotherapy, and will limit the ability of physicians to make well-informed treatment decisions for their patients," Davenport said.
In testimonials, patients and their family members wrote that ESAs alleviated symptoms of anemia, improved quality of life, and were essential for survival. (Excerpts from the testimonials appear below.)
Considering that ESAs are approved only as a substitute for blood transfusions in solid tumors, many of these letters were discussing off-label uses, thereby potentially exposing the company to an FDA enforcement action, said several attorneys familiar with regulation of drug promotion.
"The question is Amgen's control over what went on there," said a former FDA attorney, who spoke on condition that his name wouldn't be used. "Unless Amgen gave a blind grant to somebody and had no idea that this was going to happen, they have potential liability."
When pharmaceutical companies are caught making claims beyond the label, punishment is usually limited to warning letters and the public embarrassment they create, lawyers say. "On a lobbying campaign like this, a company like Amgen views this as just one battle in the campaign," said Sheldon Rampton, research director of the Center for Media and Democracy and author of books on the public relations industry. "It's conceivable that they may end up suffering some minor consequence, but if the rest of the effort succeeds in overturning the CMS decision, they will have lost this battle but won the war."