…Last week, I learned that the [children's health insurance] bill contains another unheralded earmark, also unrelated to children’s health. This one, too, funnels hundreds of millions of dollars to special interests … given the Orwellian name “Quality Incentive Payments in the End Stage Renal Disease Program,” [it] will subject hundreds of thousands of Americans on dialysis to unnecessary risk, and will in all likelihood lead to premature deaths.

The legislation earmarks up to $300 million over the next three years for clinics that achieve certain quality benchmarks while treating the more than 300,000 Americans with failed or failing kidneys who receive dialysis through Medicare’s End Stage Renal Disease (ESRD) program. Chief among those benchmarks is correction of the anemia associated with failing kidneys … The measure gives clinics a powerful incentive to continue using large quantities of one company’s drug – Amgen’s Epogen, which stimulates red blood cell production.

The House passed the bill even though the Food and Drug Administration recently issued a black box warning cautioning against overuse and the Center for Medicare and Medicaid Services rewrote its reimbursement guidelines to limit payments for overuse of the drug….

This is a great example of what public health has come to in America. How could this happen with our upstanding representatives looking out for us?

In a public health advisory, the FDA warned that high doses of Procrit, Aranesp and Epogen may increase the risk of blood clots, strokes, heart attacks and deaths in patients with chronic kidney failure.

Recent studies suggest that the drugs, which are commonly prescribed to cancer patients receiving chemotherapy, may actually make tumors grow faster and increase the risk of death, if given in high doses, says the FDA’s Richard Pazdur, who announced the new “black box” warning.

The drugs are synthetic versions of a natural protein called erythropoietin, which raises the number of oxygen-carrying red blood cells. Without erythropoietin, patients may become anemic, making them feel weak and exhausted. In chemo patients, doctors often prescribe the drugs to raise red blood counts and avoid riskier treatments, such as transfusions, Pazdur says.

Merrill Goozner wisely observes:

What struck me most about yesterday’s announcement was its timing. It has long been a hallmark of White House public relations staff that the best time to release bad news was late on Friday afternoons. That way, the least number of people will hear about it through traditional news media sources. It’s too late to make the Friday evening newscasts; and the print stories (see here and here, for instance) usually wind up inside the Saturday papers, which are the least read of the week.

Is this what the FDA wanted for this important warning? Is this the best way to counter the torrent of direct-to-consumer TV ads touting this drug by asking “if you’re ready for chemotherapy”? This late Friday afternoon release shows as much as anything how the culture of the agency has been transformed in recent years from industry watchdog to industry lapdog.

The FDA’s job is to protect the public’s health — but again and again, when problems arise with Big Pharma, the agency acts more like an industry spin doctor. Big Pharma’s corrupting influence has turned the mission of the FDA upside down.