Three popular anemia drugs, Epogen, Procrit and Aranesp, may be far less effective, and far more dangerous, than their manufacturer led the public and experts to believe, according to an investigative report.
The Washington Post reports that the drug maker Amgen may have intentionally overhyped the three drugs, while downplaying or ignoring concerns about potential side effects that may increase the risk of cancer, strokes and other injuries.
The alleged deception was aided by pouring money into congress through the use of lobbyists, who pressured the FDA and lawmakers to look the other way, the report claims.
Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones and increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery, to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.
In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. Researchers estimate that by 2002, the drugs were being prescribed to nearly half of all cancer patients. By 2007, 80% of dialysis patients were being given the drugs at levels the FDA has now deemed to be unsafe.
Doctors, Amgen Raked in the Money
Since the three drugs were administered by physicians, Amgen allegedly encouraged doctors to be more inclined to use the drugs by overfilling vials by as much as 25 percent, and offered discounts to doctors who used the drugs in large volume. This allowed doctors to take advantage of what is known as the “spread,” the difference between the price they paid for the drugs and the price they charged patients.
Lobbyists were also employed to help, getting Congress and Medicare officials to sign off on a pricing structure that allowed doctors and hospitals to be reimbursed for more than they actually paid for the drugs.
The Medicare Payment Advisory Commission estimates that the overpayments reached as high as 30%. Some doctors made as much as $300,000 a year off of the drugs alone, while Amgen made huge profits.
All the while, Amgen allegedly dragged its feet for 10 years on commitments to complete research that actually showed what effect the drugs did to patients being given them.
In the meantime, other studies began to come out that painted a disturbing picture for users about the three drugs. After studies showed that the side effects of Aranesp, Epogen and Procrit included increased cancer and stroke risk and may have been costing lives, the FDA issued a public health advisory in 2007, warning that they could increase the risk of death at higher doses. The warning to the public was accompanied by the requirement that all three drugs carry a “black box” warning, which is the most stringent warning the FDA can require a drug to carry.
Amgen claims the company was concerned primarily about patient safety, and were as surprised as anyone at studies that showed high doses could be lethal. However, the company had been facing FDA requirements for clinical trials since shortly after the drugs had first gone on the market in 1989.
More Approvals, Larger Doses
While Amgen was supposed to be meeting FDA-required standards of proof over the drugs’ effectiveness, they were instead working to convince the FDA to expand approvals so that the drugs could be used in more patients. Originally limited to the small number of dialysis patients that required blood transfusions, the three drugs were later approved for patients with more mild forms of anemia.
Although the drug maker studies were still not finished, the FDA approved the medications to treat cancer patients, then AIDS patients, then even patients undergoing hip and knee surgery. And the average dosage had tripled. The FDA had to rein Amgen in from claims that the drugs even made people happier and gave them better sex lives.
The full results of the “required” clinical trials were never released, although they were supposedly completed in 2004. The FDA claims that those results were misfiled and disappeared. Other studies were attempted and either abandoned or left incomplete. Now Amgen says that a clinical trial will be finished by 2017.
The drugs are now restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs have to undergo special training to identify high risk users and negative side effects.
Business Goes On
Recently, Amgen’s board of directors declared a dividend of 36 cents per share for the third quarter of 2012. According to media reports, the Thousand Oaks-based biotech giant will pay the dividend Sept. 7 to all stockholders of record as of the close of business Aug. 16.
This is the third dividend Amgen has paid since announcing its first in April 2011. In December, Amgen’s board declared a dividend of 36 cents per share for the first quarter of 2012. The dividends were paid in March. In April, Amgen said revenue increased by 9 percent to $4 billion in the first quarter of 2012.