The anemia drugs Epogen, Procrit and Aranesp were once blockbusters, the beneficiaries of aggressive marketing and lobbying campaigns that touted their supposed benefits, including “life satisfaction and happiness.” But according to a new report from The Washington Post, a growing body of evidence has shown that much of the research that help launch the drugs to blockbuster status not only overstated the their benefits, but also seriously downplayed the medications’ dangerous side effects, including cancer, strokes and an increased risk of death.
Procrit, Epogen and Aranesp are known as erythropoiesis-stimulating agents (ESAs). The drugs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. They are used to treat anemia in patients with chronic kidney disease, while Procrit and Aranesp are also approved to treat anemia in cancer patients undergoing chemotherapy. Johnson & Johnson and Amgen, the makers of Epogen, Amgen and Procrit, saw sales of some $8 billion per year, and the three drugs ranked as best-sellers for years. For more than two decades, Medicare annually paid out $3 billion the drugs, making them the most expensive medications covered by the program.
According to The Washington Post, drugs like Epogen, Amgen and Procrit, which must be administered by doctors, offer physicians a lucrative financial opportunity. In the case of these three drugs, the so-called “spread”- the difference between the price doctors paid for the drug and the price they charged patients – was huge. The drug’s makers also offered discounts to practices that dispensed the medications in big volumes. As a result, physicians administering Epogen, Amgen and Procrit had an incentive to administer large, and potentially unsafe, doses to their patients. As a result, more than 80 percent of 175,000 dialysis patients on Medicare who received the drugs in 2007 were exposed to levels beyond what is now considered safe.
It is a fact that Epogen, Amgen and Procrit, used in limited amounts, can restore vitality to kidney disease patients who suffer from anemia so severe that they sometimes need blood transfusions. In those very specific cases, the drugs allow patients to avoid transfusions, which can pose their own complications. But very quickly – thanks to questionable research and very heavy pressure from some lawmakers in Congress – the Food & Drug Administration (FDA) approved the three drugs for even wider use. First, the approved uses were expanded to all dialysis patients, regardless of their need for transfusions. Later the FDA would expand the drugs’ approvals to patients with cancer and AIDS, as well as those getting hip and knee surgery. Overtime, the average dose given to patients would more than triple.
According to the Post article, the research used to back wider use of the drugs often downplayed serious, deadly side effects, and overstated the supposed quality of life of life improvements they offered. In one case, a study intended to determine if Procrit stimulated tumor growth in small cell lung cancer patients was never finished. More than a decade after Johnson & Johnson launched the trial, it was halted because of a lack of trial participants. While no clear evidence of danger was found before the trial came to an end, it has since been noted that patients taking the drug appeared more likely to die than those taking the placebo.
The results of another trial to determine the drugs’ safety profile were never published, with the FDA acknowledging the report was “misfiled.” A third study, to determine if large doses of Epogen could safely be used to bring patients’ hemocrit levels to normal overstated the drug’s benefits, while downplaying what would later be revealed to a statistically significant risk of death, the Post said.
By 1994, the FDA-approved label for the drugs promised “statistically significant improvements for . . . health, sex life, well-being, psychological effect, life satisfaction, and happiness.” The claims were repeated over and over again in TV and print ads, and aimed at people with potentially fatal illnesses. The makers of Epogen, Procrit and Aranesp would tout these promises for the next 13 years, until they were forced to withdraw them when they failed to meet new FDA standards of proof.
The families of cancer patients who died while being treated with one of these medications have been left to wonder if they shortened their loved one’s lives. So far, no major lawsuits have been launched on behalf of the drugs’ possible victims. But according to the Post, Amgen has been named in whistleblower lawsuits alleging that the company engaged in illegal sales tactics. While it denies any wrongdoing, Amgen says it has reached an agreement in principle to resolve the claims, and has set aside nearly $800 million for the settlements.