FDA not giving fair warning to the public

From USA Today:

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.

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