On September 11, 2007 the U.S. Food and Drug Administration heard from an advisory panel of 19 on the question of whether or not to limit the hemoglobin (red blood cell) level of kidney-failure patients (both those who are and who are not undergoing dialysis) to not exceed 11 grams per deciliter [g/dL]. In a 14 to 5 split, the panel voted against setting a specific target level of 11 g/dL, stating that it was uncomfortable with setting a specific target in the absence of evidence proving that a level of 11 g/dL was safer than 12 g/dL. The panel explained that it was more in favor of leaving it up to the doctor’s discretion about how to treat each individual patient, and felt more comfortable with advising the FDA that a range of 10-12 g/dL was more appropriate since doctors could treat patients up to 12 g/dL (even though 9 out of 19 panelists were in favor of an 11-11.5 g/dL maximum).

The panel’s implied target range is exactly the range that Amgen and Johnson & Johnson had hoped for. The two drug companies manufacture and market ESAs to treat kidney disease and cancer patients suffering from anemia. Amgen’s Epogen is used to treat most of the 350,000 U.S. kidney disease patients undergoing dialysis, while it’s Aranesp along with J&J’s Procrit are used to treat cancer patients as well as most of the 250,000 kidney disease patients who are not undergoing dialysis. For patients undergoing treatment with these ESAs, proper hemoglobin levels are vital to maintaining their health. Studies—for example the Normal Hematocrit Cardiac Trial and the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)—have shown that improper ESA dosages can increase hemoglobin levels in excess of 13 g/dL which has lead to death, heart attacks, strokes, heart failure and blood clots in patients. However, if prescribed properly, the ESAs can help patients maintain suitable hemoglobin levels which eliminate the need for risky and inconvenient blood transfusions. From these studies, the FDA has determined that 11 g/dL would be a proper hemoglobin level. Panelists, however, are reluctant to set an 11 g/dL target level because of testimony that it heard explaining that setting too high a limit could cause some patients to go under treated, which could result in their suffering from debilitating anemia or more blood transfusions.

Amgen and J&J are working together with the FDA to reach a consensus on which hemoglobin level (or range) is appropriate to place on new warning labels. The health risks that have come to light in the past few months have prompted the FDA to make changes on warning labels and, in determining which level should appear on the label, the FDA called this panel. Even though the FDA is not required to follow the advice of its panels, it generally does so. This could mean that a 10-12 g/dL range could be adopted by the FDA for its warning labels, which could affect both the way that doctors prescribe the ESAs as well as how the U.S. Medicare Insurance program reimburses the drugs. The Centers for Medicare & Medicaid Services has recently revised its reimbursement guidelines, which some private insurers are likely to follow. A change to the levels on warning labels could affect these guidelines.

Click the following links to read the full version of articles that contributed to this posting:

Associated Press (in Forbes): “FDA Panel: Widen Target for Anemia Drugs”

The Boston Globe: “Panel Says Anemia Drug Doses OK As Is”

Reuters: “Amgen Defends Anemia Drugs Before U.S. Panel”

AHC Media LLC: “FDA Panel Vote on Anemia Drugs Gets Mixed Reviews”

“Amgen and Ortho Biotech Breathe Collective Sigh of Relief After FDA Panel Vote”

“FDA Panel Votes Against Anemia Drug Restrictions”

Reuters: “US Panel Rejects Anemia Drug Limit in Non-Dialysis”

“FDA Hemoglobin Target for Amgen, J&J Anemia Drugs Too Narrow”

Reuters: “US Advisers Against Anemia Drug Restrictions”

The New York Times: “F.D.A. Advisory Panel Opposes Curb on Anemia Drugs”

The Wall Street Journal: “FDA Panel Vote Is a Win for Amgen, J&J”

The following are related articles:

“Amgen Bulls Running Wild”

Los Angeles Business Journal: “Panel Says Anemia Drug Dosage OK”