Sales of Potentially Dangerous Anemia Drugs Raise QuestionsJul 19, 2012 | Parker Waichman LLP
Three popular anemia drugs may have generated billions of dollars in revenue for two companies but they’ve proven to be dangerous and a drain on the federal health care system and patients’ wallets.
An investigation launched by The Washington Post reveals that Amgen and Johnson & Johnson enacted an aggressive lobbying effort to federal health officials and on the back of research that clearly missed the dangers of the drugs Epogen, Procrit, and Aranesp.
Amgen was able to gain approval for the drugs and then the two companies were able to lobby the Medicare program to pay for the expensive doses of the drugs, routinely administered to kidney patients undergoing dialysis treatment. The drugs were also given widely to other patients, including those suffering from cancer.
The Washington Post reports that Epogen was once the most expensive drug covered by the federal health care program, costing upwards of $2,300 per injection. Together, the three drugs peaked on the market by generating $8 billion annually for the two companies, windfall profits by any standard. Taxpayers were paying close to $3 billion a year for the drugs but unknowingly putting millions at risk.
And while these drugs were enjoying financial success, the Food and Drug Administration was clearly ignoring safety data which pointed to the obvious dangers of the drugs and especially the overstated benefits to taking the drugs. The report believes millions of patients were at risk of suffering fatal side effects from either Epogen, Procrit, or Aranesp.
According to the Washington Post investigation: “Both pharmaceutical companies conducted trials that missed the dangers and touted benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to rein in the largest doses, a high-powered lobbying effort occurred until Congress forced the regulators to let the drugs flow.”
The FDA safety label on these anemia drugs indicates they have proven in studies to improve “life satisfaction and happiness” but has missed data that shows the opposite, including imposing a risk of cancer and stroke on patients being administered the drugs.
It was not until last year that Medicare research revealed that these three anemia drugs were providing little, if any, clinical benefit to patients suffering from kidney maladies, the class of patients they were first approved to treat.
Additionally, financially hamstrung physicians were being asked to wage profits against patient safety in administering these drugs. The companies offered incentives to doctors who delivered the highest doses of the drugs. “They offered discounts to practices that dispensed the drug in big volumes. They overfilled vials, adding as much as 25 percent extra, allowing doctors to further widen profit margins.”
The companies also got Congress and the Medicare system to compensate the participating doctors for more than they were originally paying for the drugs that they administered in their offices.