About five years ago, Suzannah, Ruth's mother, tripped on the sidewalk in front of her building and broke her hip; she needed emergency surgery. The doctor said he had to put in some 'hardware' to stop the bleeding. And she was given Epogen.
After the temporary surgery she was scheduled for a hip replacement. "My mother had a good recovery then she went to a rehab center," says Ruth. "Six months later she was going to have surgery so she continued with the Epogen—the treatment consisted of a series of injections. She wasn't much of a meat eater so the doctor said she needed these shots as well because she was anemic. Every time she had surgery, a few months beforehand she would get about 12-16 Epogen injections - a visiting nurse would come to the house and give them to her."Around that time she complained about feeling weak and lightheaded—she just didn't feel 'right'. The doctor said her blood pressure was a little elevated but it was nothing to worry about. Suzannah told him that wasn't why she felt bad...
She also had a knee replacement, her third surgery, and recovered completely from that. But afterward she remained anemic. The doctor sent the nurses to her home with more injections. She was getting weak and out of breath after this last series of treatments. She wouldn't even leave the house."
By this time, Suzannah was a shut-in. From a vibrant healthy woman to someone who could barely move was devastating. But she also got cabin fever. Suzannah went outside for a walk and fell down again; luckily her home attendant was with her and caught her before she hit the pavement.
Ruth took her back to the doctor and he just asked her about her blood pressure again. Anemia wasn't even mentioned, although the nurse was still coming to her home and giving her the Epogen shots.
"The next day I drove her to ER at Mt. Sinai—she was so weak and complained of indigestion. I was afraid that she might have had a stroke when she fell down," says Ruth. "They did every test imaginable. The doctor found an irregular heartbeat but nothing serious enough to keep her overnight.
"A month later she missed church—something she never did. My sister went over to her house, unlocked the door and found her dead. The medical examiner and her doctor came over. They determined that she had a heart attack and wouldn't require an autopsy.
She always complained about taking Epogen. 'Ever since I started taking those shots, I didn't feel right,' she said. But we told her that she had to do what the doctor ordered.
As far as I knew, Epogen was supposed to help her anemia. She wasn't anemic before these surgeries. She was a spark plug - she had more energy than I had. In fact she was coloring her hair the day before she died—she was getting ready for a big church function.
Six months ago I read a headline on the internet: 'FDA warns against Epogen' and that was when the FDA had increased the warning on the box. I was always adamant about how there was something wrong. I wanted an autopsy but my older sisters decided not to. I really regret that we don't know why she died.
If she died of a heart attack, it was caused by something because her heart was perfectly fine. I refuse to believe that she died of a heart attack without a reason. She was so healthy and I know she was taking a lot of Epogen."
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2007 was a bad year for Amgen, the maker of erythropoiesis-stimulating agents (ESAs) Epogen and Aranesp. And it looks like it is off to a rocky 2008.
The FDA will be holding yet another advisory panel in the first quarter of 2008 to discuss Arenesp and Johnson & Johnson's Procrit (the exact same compound as Epogen).
To date, the FDA is confused over when to recommend the use of the ESAs, as well as over which patients will benefit from the drugs enough to outweigh any adverse effects.
And even more bad news for the drug maker: in December, 2007 Aranesp, Epogen and Procrit have been linked to yet another deadly side effect. New research suggests that the anemia drugs might be involved in the development of a form of leukemia when they are used to treat people with a rare blood disorder known as myelofibrosis.
Wait, it gets worse: Amgen announced that a study done on breast cancer patients treated with the Aranesp showed that it offered them little help, and also placed them at a higher risk of death. Amgen said it was considering further warnings for the drugs. Aranesp and Epogen are marketed by Amgen, while Procrit is sold by Johnson & Johnson under a licensing agreement with Amgen.
Shouldn't they all get taken off the market, now?
