FDA has justified its confusing stance on ESA usage by saying, "We cannot exclude a negative survival impact when using ESAs under 12 g/dL."
What does that mean, Dr. Henry wondered, offering an analogy. "So, according to FDA logic, if you drive a car at 120 miles per hour, a bad accident is very likely, but even if you drive at a safe speed, I still can't exclude that you might be injured in a bad accident."Imagine the ethical quandary, Dr. Henry said, "when an oncology practice falls in line with CMS and refuses to cover a privately insured patient. The patient says, 'I don't have insurance with CMS, I have it with you! So why are you withholding this drug from me?'"
Effect on community practices
For this article, more than a dozen oncologists from across the country were asked how the new ESA policy affected their practices. Not surprisingly, many declined to comment. Of those who did, most agreed that the NCD and FDA labeling had made them less inclined to prescribe ESAs for two basic reasons: extra paperwork and fear of not getting paid.
One thoughtful response came from David Mintzer, MD, a hem/onc general practitioner in Pennsylvania. His eight-doctor practice has been active in clinical trials for many years studying the optimal use of erythropoietin(Drug information on erythropoietin), under the direction of Dr. Henry.
When using ESAs, Dr. Mintzer said, the priorities are patient safety and maintaining quality of life. He stressed that a two-tiered system for ESAs is medically and ethically unappealing, and that the recommended CMS guidelines are complex, cumbersome, and confusing.
"On the other hand," he added, "I do believe that the use—and perhaps more so the cost—of these agents to the medical system as a whole needed to be reined in, even before the safety concerns were raised. Oncologists, including organizations like ASCO and ASH, need to take a more active role in controlling healthcare costs. We seem to have abdicated our role in doing so."
FDA has scheduled another ODAC meeting on the use of ESAs to convene in the first quarter of 2008. Amgen is expanding its pharmacovigilance program by initiating seven new clinical trials assessing the risks associated with ESAs. More data on ESAs will inevitably add to the mountain of existing literature. The question is, who will read the data, and how will it be interpreted?