Kidney Clinics Cite Race To Fight Curb on Drug

Kidney Clinics Cite Race To Fight Curb on Drug
Blacks Would Suffer Most If Payouts, Use Are Limited on an Anemia Treatment

By AVERY JOHNSON
Wall Street Journal
September 11, 2007

The Kidney-dialysis industry is highlighting concerns about racial disparities to fend off criticism that it fattens profits by overprescribing an anemia drug that has proven risky at high doses.

Epogen, made by Amgen Inc., is drawing scrutiny amid mounting safety questions and reports of overuse at dialysis clinics. Recent research shows the risks of death and heart attacks rise considerably when the drug gives too big a boost to hemoglobin, a measure of red blood cells, while a government report says Medicare's reimbursement system actually encourages dialysis companies to use too much of the drug.

The House has passed a bill meant to deter excess use by changing the way providers are reimbursed for the drug. Today, the Food and Drug Administration plans a hearing focusing on what to do with patients who are prescribed Epogen at levels that can carry dangerous side effects.

But kidney-care companies are playing up the fact the patients who typically need the higher doses are African-American, and that they would suffer disproportionately from any curbs. Data from the U.S. Renal Data System show that in 2004, black patients were given the highest average dose of Epogen, about 20,633 units a week, compared with 17,806 units that white patients received. There have been no definitive studies on why blacks appear to need heavier doses, although many believe it is an outgrowth of high rates of obesity, hypertension, diabetes and poverty among African-Americans.

The companies' argument is bolstered by the fact that blacks make up a disproportionate number of patients: nearly 40% of those in dialysis versus 13% of the overall population.

John Jonas, chief lobbyist for Kidney Care Partners, a coalition of companies and patient groups, says, "Drug firms, dialysis companies and other lobbying groups have gone to African-Americans and the [Congressional Black Caucus] and said, 'You need to pay special attention to this.' "

The stakes are high, and rising fast. Epogen currently costs Medicare -- which by quirk of law has covered dialysis for nearly all Americans since 1972 -- about $2 billion a year, nearly triple its next-highest drug expenditure. The Kidney Care Council, an industry group, says the number of dialysis patients is expected to reach 650,000 by 2010.

DaVita Inc., one of the country's biggest dialysis companies, hired professional basketball star Alonzo Mourning -- who returned to play for a championship team after a kidney transplant -- to appear at a breakfast briefing with caucus members, where he recounted how the drug helped him have enough energy to feel normal. LeAnne Zumwalt, a vice president at DaVita, says Mr. Mourning met with lawmakers to make sure they knew this was an African-American issue when Congress considered revamping payments.

The companies also warn that cutting payments for or limiting use of Epogen, could curtail their profits to the extent that many clinics -- especially those in urban and rural areas -- would be forced to shut down. There is also a concern that underfunded clinics might dump those patients who require a lot of the drug. In either case, those most adversely affected would be African-Americans.

Although the move to force cuts in Epogen use was a Democratic initiative, the lobbying campaign has found a potent ally in the Black Caucus, whose members are all Democrats. To allay some of their worries, lawmakers drafted a bill meant to assure that anyone who needs Epogen will have access to all they need. But concerns persist that reducing payments in any way will hurt patients, and that the government needs to conduct a trial run to see how changes play out.

Ohio Rep. Stephanie Tubbs Jones, a Black Caucus member who sits on the Ways & Means health subcommittee, says some of the provisions put into the bill helped her get over her strong opposition but she is reserving judgment until the government completes a two-year review of racial disparities.

Dialysis patients get treatment several times a week to wash toxins from their blood after their kidneys fail. They suffer severe anemia, and routinely manage the condition with Epogen, which was hailed as a breakthrough when it replaced blood transfusions nearly two decades ago.

But Medicare pays for Epogen separate from the rest of the dialysis regimen, for which clinics get a fixed-rate payment. Critics say this gives dialysis firms an incentive to use more Epogen than is necessary to help them break even on the less-lucrative dialysis portion. To address this, the House bill would "bundle" Epogen into the overall payment for dialysis services.

The kidney-care industry says it isn't opposed to eliminating the split structure, but that the payments should be adjusted for inflation. Kidney Care Partners plans to ask Black Caucus members this month to push for such an adjustment. Lobbyists also are taking their message to the Senate, whose members will hash out a compromise bill with House counterparts this fall.

Some people don't buy the dialysis companies' arguments, though, and think the industry is leveraging an emotional and politically charged element of the issue to protect a lucrative business line.

Patricia Tate-Harris, whose husband spent seven years on dialysis before his death in 2005, says, "We're being used by the dialysis industry. They know this is a very sensitive issue and I question if they're truly concerned about the lack of quality care."

Alvin Harris represents the kind of patient both sides say they are fighting for. Mr. Harris was a 60-year-old African-American with diabetes, high blood pressure and heart problems when he began dialysis in 1999. He died in 2005, and Ms. Tate-Harris saved seven years of treatment records, doctors' notes and reimbursement forms that show a pattern of expensive and aggressive anemia treatment -- though the medical reasons for this aren't always apparent. (Ms. Tate-Harris, who runs a Baton Rouge, La.-based group called the Association of Dialysis Advocates, has filed a wrongful-death suit against one of the five dialysis facilities that treated her husband, though the litigation isn't related to the use of Epogen.)

Mr. Harris needed high doses of Epogen to boost his hemoglobin according to doctors' notes and records of his treatment at a clinic run by Fresenius North America, a subsidiary of Fresenius AG of Germany.

Ms. Tate-Harris became alarmed when her husband was billed for $20,496 of Epogen in May 2001. Just six months earlier, Mr. Harris had been given $10,148 worth of the drug. There hadn't been any worsening in Mr. Harris's anemia: During that period, his hemoglobin stayed in the FDA's recommended range of 10 to 12 grams per deciliter of blood, which an Amgen spokesman agrees is the most appropriate for managing patients.

Michael Lazarus, Fresenius North America's chief medical officer, says Mr. Harris's top dose -- 23,000 units three times per week -- was "a very big dose" that was much greater than Fresenius patients' average dose of 7,800 units.

In March 2003, Mr. Harris's hemoglobin hit 14, a dangerous level for people with heart disease. Recent studies show that using Epogen to push hemoglobin that high can increase mortality risks.

"It's my strong opinion that keeping his hemoglobin at 12 or higher prolonged this man's life as opposed to ending it," says Robert Kenney of Renal Associates in Baton Rouge, who was one of Mr. Harris's treating nephrologists and made decisions about his care. Dr. Kenney says he believes Mr. Harris "did better" in terms of quality of life when his hemoglobin was above 12, and dosed him aggressively to get to that level. "It was not done to bilk anyone out of money," he says. But in light of what is known now about health risks, he adds, "If Mr. Harris were alive today, I'd try to keep him around 12 but very rarely over that."

Write to Avery Johnson at avery.johnson@WSJ.com1

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