“It was just so easy to do — you put this stuff in the patient’s arm, and you made thousands of dollars,” said Charles Bennett, endowed chair at the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina and one of the critics of the use of the drug in cancer patients. “An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient.”
Take, for example, the doses of Aranesp that Jim Lenox was given several times during his cancer treatment, though not the injection he received at the hospital, which was Procrit.
The insurance company reimbursed the clinic about $900 for each, according to his patient records. The clinic would have paid about $600 for a dose of that size, at average prices from that time, meaning a profit of roughly $300 per administration.
“Jim trusted the doctors,” Sherry Lenox said.
The incentives drove remarkably high profits at Amgen — enough to elevate the small California firm into a Fortune 500 company. Its profit margin reached over 30 percent of sales, far higher than the industry average. As much as a third of that was coming from reimbursements funded by U.S. taxpayers.
Daniel Coyne, a professor of medicine at Washington University who had been a paid speaker for Amgen, promoting the drug, called the case “a paradigm for the pharmaceutical industry.”
Coyne said he became a critic after the drug’s danger surfaced and the company continued to promote higher doses.
“Amgen can say they are very contrite,” Coyne said. “They can say, ‘Isn’t it a shame that we didn’t know.’ But this isn’t a shame for Amgen. They won. They made billions.”
Amgen declined requests for interviews but responded to questions via e-mail. In a statement, the company said that as the understanding of the drugs has evolved, the company “quickly and responsibly communicated these new findings” and updated the product labeling 15 times since its approval.
“Any assertion that Amgen misled the public about the risks and benefits . . . is a gross misstatement of the facts,” the company said. “On the contrary, Amgen’s primary concern is for patients.”
As for the high reimbursement rates for the drugs, the company said it “has consistently advocated for appropriate access to vital therapies, and we routinely engage with policy-makers to share our views on key issues.”
Johnson & Johnson similarly declined interview requests but said in a statement, “As our understanding of the risk-benefit profile of [the drugs] has evolved over time, we have worked closely with the FDA to ensure new and relevant information is included in labeling.”
Emerging in the late ’80s, the new anemia drugs were among the earliest blockbusters from the nascent biotech industry.
Anemia arises when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body.
The drugs consisted of man-made versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells.
The discovery, which grew out of research funded in part by the National Institutes of Health, gave doctors an entirely new “natural” way of treating anemia. The previous method consisted of giving patients transfusions of red blood cells, a cumbersome process that can take as long as four hours.
To get the new man-made hormone approved, Amgen submitted the results of a key clinical trial of patients on dialysis. Because they, and other patients with kidney disease, frequently suffer from anemia, they would become the core market for the drugs.
That trial established that, indeed, the drug stimulated the production of red blood cells. Patients given the drug showed fewer signs of anemia — their hematocrit, or percentage of red blood cells as a percentage of blood, rose significantly.
The researchers also examined the evidence in the trials for signs of harmful side effects.
“The risks associated with [the] therapy are minimal,” Amgen wrote to the FDA.
The first two drugs of the trio, Epogen and Procrit, were approved by the agency in June 1989 for patients with kidney disease. Amgen made both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp would be approved in 2001.
For a narrow portion of those patients — dialysis patients with anemia so severe they needed occasional blood transfusions — the drugs, if used in limited amounts, did offer a critical benefit, one that doctors say amounted to a revolution in treatment. Patients with severe anemia said it could restore their vitality. The new drugs allowed them to avoid the risks of transfusions, which can carry diseases and raise future complications for transplant patients.