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Benefits of Epogen, Procrit and Aranesp Overstated, Patients Paid the Price

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Patients may have paid with their lives over three anemia drugs—Epogen, Procrit, and Aranesp—whose benefits have been overstated. In fact, financial benefits appear to have been the motivation in ensuring these drugs were broadly delivered; aggressive lobbying further ensured those benefits.

The drugs are Erythropoiesis-Stimulating Agents (ESAs). Epoetin alfa is marketed as Procrit and Epogen, and Darbepoetin alfa is marketed as Aranesp. As NewsInferno explained, ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the body’s bone marrow to make more red blood cells. Epogen is prescribed to treat anemia in chronic kidney disease patients; Procrit is approved to also treat anemia in cancer patients receiving chemotherapy.

The drug trio were among the best selling prescription medications in the United States, bringing in more than $8 billion annually for drug makers Amgen and Johnson & Johnson, noted The Washington Post. Epogen was ranked as the most expensive drug under Medicare and taxpayers spent some $3 billion a year for these drugs.

The Washington Post reports that Big Pharma was singularly focused on ensuring physicians were incentivized to treat large patient groups with large doses, offering discounts to those medical practices that used the drugs in large volumes. For example, by over-filling medicine vials—in some cases, by an additional 25 percent—even greater profit margins could be realized.

And, then, there was the lobbying. Intense lobbying, said The Post, that enabled greater reimbursements—much more so than the drug cost—under a system created by Congress and Medicare. In fact, the drugs’ mark-ups for Medicare patients that were received by doctors, clinics, and hospitals provided profits of up to 30 percent, said the Medicare Payment Advisory Commission, a Congressional advisory group. The Post noted that the markup on doses to private insurance patients was even greater.

Aside from the way in which profits were received, increasingly, medical research has revealed that for over 20 years, the drugs’ benefits, which include “life satisfaction and happiness,” according to the FDA-approved label, were grossly overstated, said The Post. In fact, the drug has been linked to potentially fatal side effects that include cancer and strokes and these side effects have been largely ignored.

In 2011, Medicare researchers issued an 84-page study that concluded that, in most kidney patients—the drugs were originally marketed to this largest demographic—no concrete evidence existed that the drugs improved how patients feel, improved patients’ survival, or provided “clinical benefit” other than increased a red blood cell count statistic, explained The Post. So, while industry enjoyed billions of dollars in profits over a staggering 22 years—much of this money from taxpayers, noted The Post—millions of patients were treated with dangerous doses of medicines that offered little or no help.

Meanwhile, Johnson & Johnson began a study of patients diagnosed with small-cell lung cancer. That study was meant to include 400 patients, said The Post; however, after 11 years, the drug giant said it was having problems recruiting the full 400 and only enrolled 224 participants. This means that the research would have struggled to make any statistically significant conclusions. Even worse, said The Post, the FDA pointed out that data were missing in 17 percent of the cases. With agency approval, the drug maker stopped the study and never found proof of any real danger, said The Post. It would be years until Medicare researchers would say that patients taking the drugs seemed to be likelier to die than patients taking a placebo. And, while Amgen researchers said the trial favored placebo group survival, it told the FDA there was insufficient information, “The data are sparse,” it said.

The drug makers agreed to conduct another study, which was supposed to be completed in 2008, and which remains uncompleted, said The Post. The study has been broadened and is expected to be completed in 2017, five years from now and 25 years after Amgen’s drug was approved for treatment in cancer patients.

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