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FDA warning drives doubts on Epogen drug

Mar 19, 2007 | Boston Globe

admonition admonitory admonition usage modification , which accounts for $2 billion in federal kidney-dialysis reimbursements.

Epogen combats anemia by raising red-blood counts in kidney patients. But Medicare has been under fire for allowing doses that exceed FDA-recommended limits and that, in clinical trials, have been shown to pose risks of fatal heart attacks and strokes.

Earlier this month, the FDA issued a black-box warning advising physicians to be more cautious about antianemia drugs. Such a warning is the strongest warning to physicians and patients that severe adverse reactions have been experienced in use of a product; it is placed in a black box at the beginning of an FDA-approved label .

The FDA decision prompted some members of Congress and some doctors to urge Medicare to reconsider its reimbursement policy.

"Maybe this FDA warning will wake them up," said US Representative Pete Stark, a California Democrat and chairman of the health subcommittee of the House Ways and Means Committee.

Stark was among members of the Ways and Means Committee who criticized Medicare payment policies for Epogen at a December hearing. Critics said Medicare's policy provides a profit incentive for dialysis clinics to increase Epogen doses.

On average, clinics nationwide earn more than 20 percent of their revenue from the drug.

Stark said the FDA warning should carry weight with Medicare. "This isn't a lobbyist or congressman who is mad," he said. "This is the people upon whom we depend to keep our pharmaceuticals in this country safe. If we're not going to respond to them, who do we listen to?"

Another call for change came from a consistent critic of the Medicare Epogen reimbursement policy, Dennis Cotter, president of the Medical Technology & Practice Patterns Institute, a nonprofit organization based in Washington.

"In view of the lack of science supporting Medicare's current position and the announcement by FDA of further tightening of the label, Medicare should immediately clarify their policy to be consistent with what is now known," he said.

Medicare said last week that it is studying the black-box warning. The warning is also being added to Amgen's Aranesp and to Johnson & Johnson's Procrit, which are used to treat kidney patients not on dialysis and cancer patients undergoing chemotherapy.

"We pay close attention to FDA black-box warnings, because the safety of our Medicare beneficiaries is paramount," said Leslie V. Norwalk, acting administrator of the federal Centers for Medicare and Medicaid Services. "We will carefully examine our policies."

The FDA said doctors should use only the minimum amount of antianemia drugs needed to help patients avoid blood transfusions. It also said oncologists should not use the drugs in an attempt to improve quality of life for cancer patients. It allowed quality of life claims to remain for kidney patients, but said it plans to reexamine the validity of those claims.

The warning has triggered discussion in the medical community about a class of drugs that has been widely used by kidney and cancer doctors for 18 years. Many physicians continue to believe the treatments help patients feel more energetic.

Partners HealthCare, the largest hospital network in New England and parent corporation of Massachusetts General Hospital and Brigham and Women's Hospital, began adopting more conservative policies for Epogen dosage for kidney patients last year. Now it will probably review its dosage protocols and reduce dosages even more, said Dr. Ajay Singh, clinical chief of nephrology at Brigham and Women's.

"We are going to be more conservative and be in line with what FDA currently believes we should be doing," he said. Singh was the principal investigator of a clinical trial of Procrit that was reported last year in the New England Journal of Medicine. The trial, called CHOIR, was halted after kidney patients who were not undergoing dialysis died at a higher rate than expected after being treated more aggressively with the antianemia drug.

But a widely respected kidney specialist at Tufts-New England Medical Center, Dr. Klemens B. Meyer, said the FDA may have moved too aggressively with its black-box warning. "I'm concerned about a regulatory overreaction that could end up harming patients," Meyer said. "There may be some real trade-offs here."

DaVita Inc., which operates the nation's largest chain of dialysis centers, with about 1,300 clinics, did not announce any immediate change in its dosage policies, but said it will review the FDA action. DaVita said it already has been reviewing dosages in light of last year's CHOIR trial and other data.

"We are very concerned that an overreaction to this label will hurt patient outcomes," said a statement issued by Kent Thiry, the company's chief executive. "We remain committed to working in partnership with our affiliated physicians, who make all prescription decisions, to achieve the best anemia-management practices and patient outcomes."

The Globe reported last year that about 20 percent of US dialysis patients receiving Epogen had red-blood-cell levels above the FDA recommended limit.

DaVita and other dialysis facility operators including the second-largest chain, Fresenius Medical Care North America, which has its headquarters in Lexington have faced criticism in Congress and elsewhere for alleged overuse of Epogen. Fresenius did not respond to requests for comment.

DaVita disclosed on Feb. 22 that it had received a subpoena from the US Office of Inspector General in Texas related to Medicare claims for Epogen.

Data collected by Medicare and maintained under contract by the National Institutes of Health show that DaVita clinics have the largest percentage of patients with red-blood-cell counts above FDA recommended guidelines. DaVita said it is cooperating with authorities.


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