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U.S. panel sees anemia drug risks in kidney patients

BALTIMORE, Maryland (Reuters) - Use of controversial anemia drugs made by Amgen Inc and Johnson & Johnson at high levels likely worsen heart problems and possibly chances for survival in kidney patients, a U.S. Medicare advisory panel said on Wednesday, calling for more study.

Outside experts on the panel told the Centers for Medicare & Medicaid Services (CMS) that they were confident that use of the blockbuster drugs, called erythropoiesis-stimulating agents (ESAs), in chronic kidney disease patients could cause harm.

“I haven’t heard anything that says higher dosing -- all things being equal -- is good,” said panelist and Dartmouth Medical School Professor Robert Steinbrook.

In a series of votes, most panelists said there was enough data to draw those conclusions about increased heart risks. At the same time, evidence also showed ESAs could improve patients’ quality of life and help them be active.

CMS, which pays for the healthcare of 45 million elderly and disabled, called for the meeting to weigh current evidence but had not yet said whether it would make a nationwide decision on how to pay for the drugs in kidney patients.

At issue is whether changes are needed to address use of the drugs -- Johnson & Johnson’s Procrit and Amgen’s Aranesp and Epogen. Concerns over possible heart risks and strong warnings for their use in cancer patients have already caused sales to slump as doctors scale back.

Like cancer patients undergoing chemotherapy, those with kidney disease can also feel the fatigue and weakness of anemia. ESA drugs aim to boost red blood cells and improve energy. Doctors use them to prevent unnecessary blood transfusions that carry their own risks as patients await possible kidney transplantation.

Current guidelines call for ESAs -- synthetic forms of the erythropoietin hormone -- to raise red blood cell levels to between 10 grams and 12 grams per deciliter, but recent studies linked higher doses to strokes, heart attacks or even death.

Experts at the meeting were somewhat divided, with Amgen and Johnson & Johnson along with several medical and patient groups backing current use.

But Harvard Medical School professor Dr. Ajay Singh told the panel data from four major clinical trials showed higher doses of ESAs offered “no evidence for benefit (and), in fact, evidence for increased risk.”

Data on whether they improved patient’s quality of life was also “inconsistent,” said Singh, who argued for a target red blood cell, or hemoglobin, level of 9 grams per deciliter.

Panelists at the meeting also called for more clinical trials to narrow down the best range between 9 grams and 12 grams per deciliter and to look as specific patient groups.

“There’s too great a gap between what we’ve observed in practice and what we know about” these drugs, said panel chairman Clifford Goodman, a vice president at The Lewin Group.

While CMS cannot make recommendations about the drugs themselves, any future payment policy changes could affect use. It has already proposed lump-sum “bundled” payments for sicker kidney patients on dialysis that aim to reduce costs for the financially-burdened agency but could also curb overuse.

Despite concerns, ESAs remain widely-used blockbuster products. They are particularly key for Amgen, which last year saw $2.7 billion in worldwide Aranesp sales and $2.6 billion in U.S. sales of Epogen.

Analysts have said greater pressure on Amgen and Johnson & Johnson shares is ahead with a planned advisory panel meeting at the Food and Drug Administration, which can make direct changes regarding use and labeling of the drugs.

Jefferies & Co analyst Eun Yang saw little direct fallout from Wednesday’s CMS meeting, recently noting that it was part of “a formal process, not as a major event for policy change.”

At the meeting, Amgen Executive Medical Director Reshma Kewalramani said “the totality of the evidence” supported the current guidelines “consistent with product labeling.”

Johnson & Johnson’s Scott McKenzie, who oversees economic and outcomes research at its Ortho Biotech Products unit, said despite concerns “studies show increases in quality of life.”

Patients said it should be up to doctors and patients to determine the best dosing, and several said they need higher red blood cell levels to feel better. At levels of less than 12 grams, “I felt like a sack of dirt,” patient Nancy Scott said.

After the meeting, CMS’s Director of Coverage and Analysis Louis Jacques said the agency would weigh panelists’ comments.

Shares of Amgen earlier closed off 1.65 percent on the Nasdaq and shares of Johnson & Johnson finished of 0.93 percent on the New York Stock Exchange on Wednesday, while overall drugmakers’ shares closed down 0.88 percent on the NYSE Arca Pharmaceutical Index.

Reporting by Susan Heavey; editing by Carol Bishopric

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