FDA Panel Backs More Study of Anemia Drug Risks

A U.S. advisory panel voiced support on Tuesday for further research to determine whether widely used anemia drugs sold by Johnson & Johnson and Amgen Inc. might stimulate tumor growth.

A U.S. advisory panel voiced support on Tuesday for further research to determine whether widely used anemia drugs sold by Johnson & Johnson and Amgen Inc. might stimulate tumor growth. Both companies told the U.S. Food and Drug Administration committee of outside experts there was no evidence to link the drugs, Johnson & Johnson’s Procrit and Amgen’s Aranesp, to a tumor risk. Officials from both firms said they had studies ongoing that should shed light on the issue. Shares of Amgen fell 24 cents to close at $57.70 on Nasdaq. Johnson & Johnson shares slipped 13 cents to close at $54.80 on the New York Stock Exchange. The FDA advisers suggested modifications to the research but generally supported the companies’ plans. “Several of these (studies) will be addressing the important issues that bought us here today,” said Dr. Bruce Cheson, head of hematology at the Lombardi Comprehensive Cancer Center in Washington and the panel’s acting chairman. The drugs are bioengineered versions of a human protein, erythropoietin, that stimulates production of red blood cells. Combined sales of the anemia drugs, which are often given to cancer patients, amount to several billion dollars a year. Safety questions about Aranesp and Procrit arose after two studies revealed shorter survival times for patients given similar drugs sold in Europe. “We have these evolving safety concerns. They cannot be dismissed,” Dr. Harvey Luksenburg of the FDA’s division of therapeutic, biological and oncology products, told the committee. Matt Geller, an analyst who follows Amgen for CIBC World Markets, said he did not think the concerns would weigh down sales of the drugs. The panel agreed no conclusions can be drawn from current data, and new findings will not be ready for at least two years, he said. “I think this is one more worry that people have had that should be removed from the investors’ bag of worries,” Geller said. FDA officials stressed the products offer a valuable alternative to blood transfusions for fighting anemia, a shortage of red blood cells that can cause severe fatigue.The European studies were evaluating a different, unapproved use. They were testing a theory that the anemia medicines could make chemotherapy and radiation more effective by pushing hemoglobin levels even higher than what is recommended for quelling anemia. An increase in blood clots, a known risk of the anemia drugs and of cancer, might have accounted for the difference in survival times, Johnson & Johnson officials said. The controversy may lead some patients to avoid the drugs, said Musa Mayer, a cancer survivor and the panel’s patient representative. “Some may choose to have transfusions and to avoid (erythropoietin) until these issues are resolved, while others may decide it’s a reasonable risk to take,” she said. (Source: Reuters Health, May 2004)