Safety of Epogen dosages questioned

Ventura County's largest private employer built its empire on a miracle: a drug that reduced the need for blood transfusions among legions of American dialysis patients and their suffering counterparts worldwide.

The astounding product, Epogen, even countered the anesthetizing fatigue that accompanies each dialysis session, Amgen of Thousand Oaks pronounced for 18 years after the drug's 1989 debut.

"We focus on science that uncovers new ways of understanding biology, makes significant contributions to medical knowledge, and can be applied to new approaches to treating disease," Amgen spokeswoman Christine Regan said in an email outlining company philosophy.

"Amgen's mission is to serve patients," she said.

But after more than two decades of widespread use and $60 billion in Medicare payments for the drugs, new regulatory guidelines have questioned the safety of Epogen dosages and dosages for Amgen-developed descendants of the product.

Health experts are coupling that development with Amgen's political lobbying against a proposal to provide kidney transplant patients a lifetime of the drugs needed to keep them off dialysis. They are sharply critical of the company.

"Over the years, Amgen has given us ample evidence that they're a very strategic, profit-motivated Corp. with questionable regard for patients' health or safety," said Rep. Pete Stark, D-Fremont, who has called for restrictions on Epogen use as a ranking member on the House Ways and Means health subcommittee.

Regan acknowledged that Amgen joined the rest of the dialysis industry in successfully opposing the kidney medication proposal by Sen. Dick Durbin, D-Ill., which was extracted last winter from the health reform law. Durbin has pledged to reintroduce the measure before year's end.

Though the Congressional Budget Office estimated it would cost a relatively modest $100 million a year to fund the kidney medications, Regan argued the money could not be spared from Medicare's $8.6 billion annual dialysis budget. Amgen receives at least $2 billion a year from that Medicare coffer for providing Epogen and its other drugs.

"The important goal of expanding access to immunosuppressive drugs for transplant patients should not be tied to policies that will restrict access to other products of critical importance for dialysis patients," Regan said.

Lori Hartwell, a four-time kidney transplant patient who started the Glendale-based Renal Support Network, put it more simply: "We didn't feel it was fair to take away from one group to help another group. We wanted a different solution."

Hartwell's nonprofit organization for patients is part of a national lobbying group that includes Amgen and the country's largest dialysis providers.

The director of the kidney transplant program at Cedars-Sinai Medical Center in Los Angeles, Dr. Stanley Jordan, said he's disappointed Amgen opposed legislation providing the lifetime benefits. The company has been at the forefront of kidney disease awareness, he said.

"I don't see their argument," the doctor said. "I don't think there's a sustainable position."

Today, nearly all U.S. dialysis patients, as well as some cancer and HIV patients, are prescribed the Amgen drugs.

But with its home run drug, Amgen was forced to backtrack on a powerful initial claim.

The company's long-standing citation of studies asserting Epogen fought fatigue was scrutinized by the U.S. Food and Drug Administration, which instructed Amgen and other drugmakers to reconsider such claims in 2007. Amgen now says on official company disclaimers for the drug that "Epogen has not been proven to improve quality of life, fatigue or well-being."

Amgen's assertion that the drug helped dialysis patients recover from the unrelenting fatigue that relegates many of them to part-time lives was based upon studies that posed open-ended survey questions to patients, said Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit that evaluates the clinical and economic implications of health technologies.

By 2009, his studies showed strong evidence the drug increased risk for stroke, heart attack and death. His most recent findings, published last month, show a 28 percent increase in the risk of death for diabetic patients receiving higher dosages of the drug.

"What we do know, what we demonstrated, is that with high doses of Epogen the risk went up tremendously," said Cotter.

After years of issuing more-stringent warning labels, the FDA finally announced on June 24 new guidelines that are projected to slash the U.S. clinical use of Epogen by as much as a third. The FDA cited the increased risk of cardiovascular events ranging from stroke to death.

Amgen-developed offshoots of the drug called Aranesp and the Johnson & Johnson product Procrit, which is manufactured by Amgen under contract, are projected to see similar reductions in use.

The company issued a news release that coincided with the FDA announcement on June 24, saying it supported the new guidelines.

Years of regulatory scrutiny of showcase products might have been enough to cripple other companies. But by the time the benefits of Epogen were challenged by researchers and regulators, Amgen had become the world's largest biotechnology company with enviable political influence.

According to the Washington, D.C.-based Center for Responsive Politics, Amgen spent $10.2 million on federal political lobbying in the most recent full year of 2010. That is second only to drug giant Pfizer, which spent $13.3 million on lobbying.

Amgen also raised its charitable profile with its Safety Net Foundation program, which Regan said is providing free Amgen drugs to 7,600 patients currently enrolled.

Dr. Kant Tucker, who operates Simi Valley-based Kidney Center's eight dialysis sites in Southern California, said Epogen's undisputed ability to reduce the need for blood transfusions can't be overemphasized.

However, he wishes the drug was less expensive. It accounts for an estimated one-fifth of all Medicare dialysis expenditures.

"One starts to wonder when the price will start to come down," he said.

That could happen because Amgen's patents on Epogen products will begin to expire over the next few years, allowing the production of generics.

Cotter said his organization will continue to measure the safety of Epogen-type products, no matter who makes them.

But criticism of Epogen can be a hard sell to very ill dialysis patients who for years have taken the drug under the belief it helps with dialysis fatigue in addition to reducing the need for transfusions.Ron Taubman, a Santa Clarita resident who was on dialysis before receiving a kidney transplant last year, said he has no doubt that Epogen helped him recover from grueling dialysis sessions.

"I would sit and shiver. I was cold all the time. I would be getting aches and pains," said Taubman, who leads a Ventura and West San Fernando Valley support group of transplant recipients.

"It was a slow process, but I felt a whole lot better."

The reason Taubman felt better, Cotter said, also is what makes the drug dangerous. When Epogen increases red blood cell counts, it also increases blood viscosity, to the point that it has trouble passing through the circulatory system. That creates high blood pressure and a host of other problems among kidney patients, who are already often diabetic.

"There is much more work for the heart to do to pump blood," said Cotter. "That becomes the rub."

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