July 23, 2012 — The Washington Post has published an in-depth investigation regarding the rise and fall of anemia drugs (Epogen, Procrit, and Aranesp) sold by the drug companies Amgen and Johnson & Johnson.
These drugs have been in use since the late 1980s, and doses steadily increased through the 1990s with drug companies promoting them as a way to improve quality of life. However, critical studies were published in the mid-2000s linking high doses of the drugs to tumor growth, heart problems, and strokes. Amgen has recently agreed to settle a lawsuit from state and federal regulators accusing the company of illegal marketing tactics.
In the original clinical studies, researchers and the FDA missed signs about the safety and effectiveness of anemia drugs. They were approved and marketed as a way to improve a patient’s “life satisfaction and happiness.” When the FDA asked the drug companies to conduct more thorough safety studies, the companies spent more than a decade conducting the studies.
Throughout the 1990s and early 2000s, the drug companies created an incentive that encouraged doctors and clinics to dispense higher doses of the drug. At the time, doctors treating Medicare patients were reimbursed per dose by the U.S. government. The drug companies gave doctors a discount when they purchased large volumes of the drugs, or administered large amounts. The drug companies also topped-up each vial with an extra 25%, which allowed doctors to administer doses of the drug they had received for free, but charge the Medicare system the full amount. In some cases, this could translate to hundreds of thousands of dollars in profit every year.
Amgen also profited significantly from the steadily increasing doses, making billions on the anemia drugs. The company transformed from a small Californian pharmaceutical firm into a Fortune 500, largely due to the 30% profit it made on the anemia drugs. One-third of this profit came from the U.S. taxpayer.
Patients began getting increasingly higher doses of the drugs. Until 2007, 80% of 175,000 dialysis patients on Medicare were getting higher doses of anemia drugs than what the FDA recommended. Other patients were also getting high doses of the drugs. Amgen successfully won expanded FDA approval of the anemia for patients who had cancer and minor anemia. This greatly expanded the number of people who could potentially use one of the drugs.
Unfortunately, later research would suggest anemia drugs actually encouraged tumor growth and reduced the survival time for people with cancer. The FDA has placed a black box warning on the drugs to warn that they can decrease survival time for cancer patients.
Independent research eventually began pointing to serious side effects with the anemia drugs. One of the first studies had to be terminated early because researchers noted higher rates of heart attacks and death in patients receiving the “normal” high doses of the drug. However, this warning sign did not prompt regulatory action. It was not until other studies were published that the FDA took action.
In 2006, the New England Journal of Medicine published a study linking the drugs to a higher risk of hospitalization, stroke, or death in kidney patients. Other studies also found increased risks with the higher doses of the drugs.
In 2011, Medicare researchers found zero evidence that anemia drugs made kidney patients live longer, feel better, or do anything except elevate their red blood cell count.
The FDA has responded to this research by lowering the maximum recommended dosage. The agency also revoked the approval for minor anemia, and recommended that doctors only prescribe minimal amounts of the drugs when they could help avoid a blood transfusion.
The U.S. government also changed the way it reimbursed doctors caring for Medicare patients. Doctors are no longer paid per dose, but instead paid per patient. This removes a drug company’s ability to incentivize large dosages of a drug.
Amgen has faced multiple lawsuits alleging the company engaged in illegal marketing practices and defrauded the U.S. Medicare system. In October 2011, facing 10 whistleblower lawsuits and investigations from state and federal authorities, Amgen agreed to settle lawsuits for $780 million. The sum represents a fraction of the billions in profit that Amgen made on the drugs.