Amgen is accused in overfilling anemia medicine Aranesp so that doctors could give the “free”medicines to patients and then bill insurance companies for it. In this case, drug makers worked hard to make sure that doctors give large doses so that the incentive was large. They offered discounts if the drug was used in large big volumes. They overfilled vials, adding as much as 25 percent extra, allowing doctors to further widen profit margins. Most critical, however, was the company’s lobbying pressure, under which Congress and Medicare bureaucrats forged a system in which doctors and hospitals would be reimbursed more for the drug than they were paying for it. In addition, investigations into the company’s misconduct involve the marketing, pricing and dosing of its anemia drugs, along with the promotion of clinical trial data on their safety and effectiveness.
When FDA raised safety concerns, the drug makers agreed to conduct two key safety studies. The first was supposed to evaluate the drug’s “safety profile” and enrolled 2,100 patients. Scientists affiliated with Amgen published “interim” results in 1991 and 1993.But the full safety results of the study were never published, and in later lists of safety investigations by the FDA and Amgen, there appears to be no reference to this study.The second safety report would arise as the drugs were being approved for cancer patients. In 1993, the companies agreed to conduct a study of whether the drugs might have “stimulatory effects” on tumor growth.
Eleven years later, the company said it was having difficulty recruiting patients, having enrolled only 224. That meant it would be harder to reach statistically significant conclusions. Moreover, the FDA noted that in about 17 percent of the cases, data were missing. With FDA approval, they halted the study, never finding evidence of clear dangers. But as Medicare researchers would later remark, the patients taking the drugs appeared more likely to die than those taking the placebo.Amgen scientists agreed that the trial results favored the survival of the placebo group but wrote to the FDA that there still wasn’t enough information.With the abandonment of that trial in 2004, the drugmakers committed to doing another study, which was supposed to be completed by 2008, according to an FDA letter to Amgen.It still has not been completed.It has been enlarged, Amgen officials said, and is not expected to be finished until 2017 — nearly 25 years after the drug was approved for use in cancer patients.The anemia drugs have been huge sellers with sales of two billion dollars a year or more. But concerns have arisen in recent years that overuse of the drugs has contributed to problems like heart attacks and strokes and, in cancer patients, a worsening of the cancer.
Amgen has said that it has set aside $760 million to settle the various investigations and lawsuits.