The FDA has recommended since 2007 that doctors decrease Epogen doses when a patient’s hemoglobin level approaches 12 because of clinical trials that showed increased rates of death at levels targeted above 12.
Company officials said they were unable until recently to cut off dosages at level 12 without dropping hemoglobin in some patients to dangerously low levels.
DaVita’s Nissenson said the company was attempting to get more of its patients within the 10-12 hemoglobin window “long before there was a whisper of bundling.”
Two firms, 60% of market
DaVita is the second-largest dialysis provider behind Fresenius Medical Care North America. The two for-profit companies account for 60 percent of the market.
Denver leaders hailed DaVita’s decision in May 2009 to relocate here from El Segundo, Calif. The company says it plans to fill its new headquarters with 1,000 workers.
Thiry bikes with Denver mayoral candidate Chris Romer and sits on a city budget task force. Thiry and Gov. John Hickenlooper appeared together on stage in February for a corporate relocation celebration that had all the fervor of a pep rally, complete with DaVita workers in plumed Three Musketeer hats and plastic swords who responded with boy-girl “Yo, DaVita” shoutouts.
Thiry has donned a Three Musketeer outfit to remind employees of the company motto: “All for one, one for all.”
The 55-year-old, who holds a master’s degree in business administration from Harvard, is described as a charismatic leader and is widely credited with pulling the company, then known as Total Renal Care, back from the verge of bankruptcy in 1999.
He created a company where he is the mayor of what he calls “DaVita village” and the employees are teammates. The result has been a Wall Street growth machine. Over the past decade, DaVita has amassed 1,612 dialysis centers nationwide. It treats about 125,000 dialysis patients, many of whom have their treatment paid for by the government.
Since 1973, almost anyone who needs dialysis in this country has been able to get it through the federal Medicare program. Americans with kidney failure have guaranteed government insurance regardless of age or income, thanks to an act of Congress that followed harrowing stories of the rationing of care.
The program has grown to a $23 billion annual expense to taxpayers, providing care to about 340,000 patients, many of whom are poor and from disadvantaged communities. Of that expense, about $2 billion has been spent annually on Epogen — the largest Medicare drug expenditure.
Medicare and Medicaid payments make up more than 60 percent of DaVita’s revenue, according to the company.
End-stage kidney-disease patients usually stay on dialysis for the rest of their lives or, for a small percentage of patients, until they receive transplants.
Patients with highest levels
DaVita certainly is not the only kidney-care company under scrutiny for its use of Epogen. But DaVita patients historically have had the highest hemoglobin levels — levels controlled by the drug — of any company, according to congressional testimony and the U.S. Renal Data System.
Studies have shown that high hemoglobin levels — particularly those targeted above 12 in pre-dialysis and dialysis patients — can pose an increased risk of heart attack and stroke.
The first drug trial to raise concerns came more than a decade ago. That study, sponsored by Amgen, the manufacturer of Epogen, was halted in 1996 when there were more deaths and heart attacks among patients treated with anemia drugs that pushed hemoglobin levels up to 14.
The study found 30 percent of the patients at the upper range of dosing died, compared with 24 percent of the patients who received Epogen that kept their hemoglobin level at 10.
A clinical trial in 2006 was halted after it found chronic pre-dialysis kidney patients treated with Procrit, an anemia drug similar to Epogen, had more deaths and heart attacks when their hemoglobin levels were raised to 13.5. In a group of 715 patients given the higher dose, 52 died; in a group of 717 given the lower dose, 36 died. Although that study was based on pre-dialysis patients, the FDA warning that followed is for all patients with chronic kidney disease.
That same year, during a congressional hearing to investigate Epogen’s use, then-U.S. Rep. Bill Thomas, R-Calif., told Medicare officials: “You seriously need to consider that your payment policy is killing people.”
In 2007, the FDA released a “black box” warning — the most serious kind of drug warning — saying hemoglobin levels pushed high by Epogen could lead to heart attacks and stroke. The FDA recommends decreasing the dose of Epogen when a patient’s hemoglobin level approaches 12. If that doesn’t work, the recommendation is to temporarily stop prescribing Epogen.
|
|
2 |
|
