March 14, 2008
Panel Seeks New Limits on Anemia Drugs

By ANDREW POLLACK



A federal advisory panel, in response to mounting safety concerns, called on Thursday for additional restrictions on the use of anemia drugs by cancer patients.


The recommendation by a committee that advises the Food and Drug Administration could lead to an additional decline in sales for the drugs: Aranesp, made by Amgen, and Procrit by Johnson & Johnson.
But the two companies avoided the outcome they most feared: a recommendation that the drugs not be used by any cancer patients. That probably would have meant the loss of at least $1 billion in sales for each company.


“They dodged the really big bullet, but they still took some damage,” said Geoffrey C. Porges, a biotechnology analyst at Sanford C. Bernstein & Company.


Yaron Werber, an analyst with Citigroup, estimated that Amgen would lose about $125 million in Aranesp sales if the recommendations were enacted. That would be about 25 percent of Mr. Werber’s already reduced projections for 2008 sales to cancer patients in the United States. The meeting was held because eight clinical trials suggested that the drugs might make cancer worse for some patients or even shorten their lives. Cancer patients take Aranesp or Procrit to counter the anemia caused by chemotherapy.


The difficulty for the committee was that those eight studies involved high doses of the drugs. There was very little solid information on whether the drugs were dangerous at doses typically used by cancer doctors.
Faced with that information, the panel voted 13 to 1 in favor of recommending that the drugs remain available for use by many cancer patients.


But the committee then voted 9 to 5 in favor of recommending that the drugs not be used by patients with either breast cancer or head and neck cancer because the evidence of a risk was strongest for those types of tumors.


The committee also voted 11 to 2, with 1 abstention, to recommend that the drug not be used by patients being treated with the intent of curing their cancers. The definition of that category is vague, but it generally refers to patients with early-stage cancer who are undergoing chemotherapy after surgical removal of a tumor, in which the doctors hope the cancer has been eliminated. F.D.A. officials said after the meeting that most use of the anemia drugs was for patients with more advanced cancers.


The panel members also recommended that patients be made to sign consents in order to obtain the drugs. But the panel voted against carefully controlling distribution of the drugs.


The F.D.A. itself is expected to revise the labels of the drugs in consultation with the manufacturers. The agency does not have to adhere to the recommendations of its advisory committees, although it usually does.


In a statement, Amgen said it was “committed to working with the F.D.A. to consider the input from the committee and to implement future label changes.”


Amgen’s shares rose nearly 5 percent, closing at $47.18. Shares of Johnson & Johnson, which is not as reliant on the drugs, closed up 26 cents, to $62.81.


Sales of the anemia drugs have already been plummeting because of safety concerns and payment restrictions by Medicare and other insurers. Sales of Aranesp fell 12 percent, to $3.6 billion, in 2007, down from $4.1 billion the year before. The sales slump has forced Amgen to cut its work force.
Amgen has said that $1.55 billion of its Aranesp sales last year were for cancer use in the United States and an additional $550 million for cancer use in other countries. Most of the rest involved treating anemia stemming from kidney disease.


The use of the drugs on kidney patients was not the subject of the meeting on Thursday. Amgen’s other anemia drug, Epogen, is primarily used for kidney dialysis patients.


Johnson & Johnson had sales of $2.9 billion last year for Procrit and Eprex, a similar drug sold outside the United States. Both are sold under license from Amgen.


Amgen and Johnson & Johnson, which made a joint presentation to the committee, argued that it was not clear the drugs were dangerous. They said that the drugs should remain available because they help chemotherapy patients avoid blood transfusions, which carry their own risks of infections and side effects. The risk of contracting AIDS or hepatitis from a transfusion has declined significantly in recent years, they said, but other unknown pathogens might arise.


“The known risks of blood transfusions are less today than yesterday,” Dr. William N. Hait, a Johnson & Johnson executive, told the panel. “We do not know if that will be true tomorrow.”


The companies proposed some changes in the drugs’ labeling that would reduce their use somewhat, but less than if the drugs were barred completely for certain cancers. But Dr. Vinni Juneja, an F.D.A. official, said in his presentation that the drugs did not totally eliminate the need for transfusions but only reduced them by about 50 percent.
Some patients or patient advocates testified in support of the drugs, while others said they were more concerned about the risks or that the matter was too confusing to know what position to take.


The meeting on Thursday was the third advisory panel meeting the F.D.A. has held on the risks of these drugs’ use for cancer patients. The earlier ones were in 2004 and last May.


“There is a perceived lack of progress,” said Carlea Bauman, president of the Colorectal Cancer Coalition, an advocacy group. The drugs, she said, “have been on the market for many years, billions of dollars have been spent by insurers, millions of patients have been treated, and yet we still have many of the same unanswered questions,” as at the 2004 meeting.
Several committee members and patient advocates called on the drug companies to end sales programs that might give doctors a financial incentive to overuse the drugs. Doctors typically buy the drugs, administer them to patients, and are reimbursed by insurers and patients. The doctors can profit if the reimbursement is greater than what they paid, and companies can sweeten that margin by giving the doctors discounts and rebates.


“The current system has led to distrust,” Robert L. Erwin, president of the Marti Nelson Cancer Foundation, told the committee.
Amgen and Johnson & Johnson said the payment system, common for oncology drugs, did not lead to overuse.



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