Dr. Henry stressed that ESAs, used under the proper guidelines, improve quality of life. "There are very good placebo-controlled trials that demonstrate that," he said.

Dr. Henry pointed to the work of noted quality-of-life expert, David Cella, PHD. As far back as 2003, Cella et al found a relationship between quality of life and hemoglobin levels. Using the FACT-AN scale, 25% of cancer patients with hemoglobin levels ≤ 12 g/dL reported they were unable to work, compared with only 8% of patients with levels > 12 g/dL.

Dr. Cella's work on ESAs was also noted as evidence at the pivotal May 2007 ODAC meeting. Presenter Jeffrey Crawford, MD, chief of medical oncology, Duke University, cited five Cella-led studies looking at the impact of anemia-driven fatigue on health-related quality of life that clearly "favor the use of epoetin alfa(Drug information on epoetin alfa) and darbepoetin."

According to Dr. Henry, CMS and FDA have caused undue friction by what the major organizations and some members of Congress see as opportunistic interpretation of the pertinent data. CMS contends their decision was made by reviewing 800 prominent articles in the literature that speak to the ESA issue.

"Why then did ASCO, ASH, NCCN, and even the European guideline writers come to a different conclusion on the use of ESAs after reviewing the same 800 papers?" Dr. Henry asked. As a clinical investigator, he referred to the CMS interpretation of the literature as nothing short of wrongheaded.

FDA labeling draws fire

As late as November 2007, testifying before a Congressional subcommittee on healthcare, the director of FDA's Office of New Drugs and of the Center for Drug Evaluation and Research, John K. Jenkins, MD, said, "At this time, FDA continues to believe that ESAs are safe and effective when used at the recommended dose and approved indication."

Many oncologists wondered how, once again, reviewing the same data as CMS did, FDA could conclude ESAs were "safe and effective" above the 10 g/dL level, which CMS had made as its cut-off point, citing lack of efficacy.

Dr. Henry explained that the two-tier coverage created by the CMS-FDA policy has left clinics and hospitals struggling. It is ethically discomforting and administratively burdensome to implement one treatment protocol for Medicare patients and another widely diverging protocol for all other patients, he said.