July 23, 2012 — The Washington Post has conducted an in-depth investigation regarding the anemia drugs Epogen, Procrit and Aranesp, manufactured by the drug companies Amgen and Johnson & Johnson.
For decades, these drugs were some of the highest-grossing drugs in the United States. In 2006, researchers began publishing studies linking the drugs to severe side effects. In 2011, Amgen agreed to settle lawsuits alleging the company overstated the benefits of the drugs, incentivized doctors to prescribe dosages above the FDA-recommended limit, and minimized the life-threatening risks of cancer, heart problems, and strokes.
Although anemia drugs were promoted for decades as a way to improve a patient’s “life satisfaction and happiness,” in 2011, Medicare researchers found that there was no solid evidence they made kidney patients feel better, survive longer, or help a patient beyond elevating their red blood cell count.
In the initial clinical trials before the drugs were approved, researchers missed warning signs about risks and ineffectiveness. When the FDA asked the companies to conduct studies to better determine the risks and benefits of anemia drugs, the companies stalled and refused to release the results for more than a decade. When regulators attempted to lower the does, the companies aggressively lobbied until Congress forced regulators to back off.
During this time, the drug companies created a financial incentive program that encouraged doctors to prescribe high doses of the drug. They offered discounts to clinics that dispensed larger volumes of the drug. They also gave doctors free amounts of the drug, which increased the doctor’s profit when the free drugs were charged to the Medicare system. This allowed doctors to widen their profit margins when they prescribed large amounts of anemia drugs.
In 2007, 80% of 175,000 dialysis patients on Medicare were being given doses of anemia drugs that were higher than the FDA’s recommended limits.
Amgen profited enormously from the incentive system. The company was making more than 30% profit on sales of the drug, with one-third of the profit coming from the U.S. taxpayer. The company made billions of dollars, and quickly became a Fortune 500 business.
The company won FDA approval for an expanded list of ailments, increasing the number of potential customers. The average size of the dosages more than tripled. The added approvals included patients with cancer — although later research would link high doses of anemia drugs to higher risk of cancer. The drugs now carry a black box warning that they can decrease the survival time for patients with some cancers.
Eventually, studies were conducted to determine the ideal dose of an anemia drug in various patient groups. However, within just a few years, the researchers noted higher rates of heart attacks and death in the patients receiving the “normal” high-doses of drugs. The researchers were forced to halt the study. Despite the warning sign, the FDA did not make any recommendations about the ideal dosage.
In the mid-2000s, independent researchers published studies challenging the safety and effectiveness of high doses of anemia drugs. In November 2006, a study in the New England Journal of Medicine linked anemia drugs in kidney patients to a higher risk of hospitalization, stroke, and death. Other researchers also found serious warning signs.
Soon after, the FDA lowered the maximum recommended dosage, and revoked the drugs’ approval for minor anemia. Doctors were recommended to only use the minimum to avoid a blood transfusion.
Government officials also changed the way doctors are reimbursed for Medicate payments. Instead of paying doctors per dose of a drug, doctors are allowed a certain amount of money per dialysis patient. This removes a drug company’s ability to incentivize doctors to prescribe more doses of a drug.
In 2011, Amgen was force to pay $780 million to settle lawsuits from federal and state investigators, including 10 whistleblower lawsuits, which accused the drug company of using illegal sales and marketing tactics to promote the anemia drugs. The settlement represents a fraction of the billions in profits.