FDA Panel Wants Anemia Drug Warnings
Experts Concerned Drugs Are Overprescribed Despite Risks
Marketing Questioned continued...
"Most doctors and most patients think this drug has been approved
because it improves quality of life, it improves fatigue. There's a lot of
sleight of hand here on how the drug is used ... and that's a problem,"
says Otis Brawley, MD, a professor of oncology at Winship Cancer Institute at
Emory University in Atlanta and a member of the panel.
Maha H.A. Hussein, MD, the panel's chairwoman, says she doesn't want to see
the drugs pulled from the market because they are important for "supportive
care." But she also suggests that company marketing has urged doctors to
give higher-than-recommended doses under the assumption that boosting red blood
cell counts translated to more comfort for patients.
"We started out with a huge problem, which is the ad campaign
problem," says Hussein, a professor of medicine at the University of
Doctors are allowed to prescribe drugs for any reason, but FDA regulations
forbid companies from promoting drugs for unapproved uses.
Richard Pazdur, MD, head of the FDA office in charge of cancer drugs, says
agency officials are looking into why apparently aggressive promotional
campaigns were left unchecked.
"There's a lot of concern that these are being promoted with
quality-of-life claims that are not in the label," he says. "I think
they need to give the American public a clear understanding as to why these ads
were allowed to continue."
Experts Thursday urged the agency to go further in restricting use of the
drugs in cancer patients, though they provided little clear guidance on what
those restrictions should be. Experts said the agency should consider
discouraging the drugs' use in patients with several forms of cancer. They also
urged that doctors be warned to discontinue using the drugs once chemotherapy
The FDA's actions depend in large part on the results of several ongoing
studies, Pazdur says.
The drugs are also approved for use in patients with kidney failure. FDA
officials said they were planning a public review of the drugs' safety in those
patients for the fall.
"We will be working the FDA as they consider the committee's
recommendations," says Amgen spokeswoman Trish Hawkins.