Patient Advocates Win Big One
If you ever hear the words Aranesp, Procrit, Epogen, or ESA from your doctor, please be sure to ask, "What? Why? How can this help? How can it hurt? Are there other options?"
The U.S. Food and Drug Administration has just made it very likely that you'll get the information you need, without even having to ask. On February 16, the agency determined to protect cancer patients undergoing chemotherapy from the dangers posed by Erythropoiesis-Stimulating Agents (ESAs). This is a big win for cancer patient advocates.
ESAs are red-blood-cell boosters often given to patients undergoing chemotherapy in order to prevent anemia. But, major risks come with ESAs, as studies have shown: risks of heart problems, blood clots, and life-threatening thrombotic events. If this were not bad enough, rather than helping patients get well, ESAs actually increase tumor growth and shorten survival in breast cancer patients and other patients!
Patient advocates have been talking about these threats for several years. SHARE's own Lilla Romeo testified about them at the FDA. I wrote an article about them for the SHARE newsletter. Many other SHARE participants have long been arguing to the FDA and to medical forums about the need for better oversight and better disclosure by health care providers of risks posed by ESAs.
The medications covered by the FDA's action are marketed by Amgen under the names Aranesp and Epogen and by Centocor Ortho Biotech Products under the name Procrit.
ESAs were used for many years on patients with many different types of breast cancer. Generally they were given after chemotherapy had actually reduced patients' hemoglobin levels. But sometimes, they were used "preventively."
My own experience exemplified a standard of care-less-ness practiced by some physicians using ESAs. My oncologist told me that Aranesp was indicated to "prevent" possible low hemoglobin, which might halt my chemotherapy. I was an ignorant, trusting patient who questioned little. Later I learned that these two preventive shots were likely not necessary, because my hemoglobin had always been low. Had any mention been made of risks, I certainly would have taken a wait-and-see approach.
This scenario can't happen any more. What the FDA has now done is require the manufacturer of these products to develop a Medication Guide explaining the risks and benefits of ESAs, and this Guide must be provided to all patients receiving an ESA. Most important, the patient and the doctor have to sign an acknowledgment of risks before ESA is given.
Amgen, in collaboration with Centocor Ortho Biotech Products, must also develop a guide for oncology care providers called ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs). Under the ESA APPRISE, Amgen must ensure that only those hospitals and healthcare professionals who have completed training in the APPRISE program prescribe and dispense ESAs to patients with cancer. Amgen must oversee and monitor the program to make sure that hospitals and healthcare professionals toe the line and fully comply with all aspects of the program. This program will be implemented within 45 days after FDA approval.
As part of the enrollment in the ESA APPRISE Oncology program, healthcare professionals must attest to understanding the following, among other things:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancer.
- ESA use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.
- If ESAs must be used for certain patients (see next paragraph), the lowest dose of ESAs should be used that can avoid red blood cell transfusion.
- Aranesp is indicated for the treatment of anemia due to the effect (emphasis added) of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies receiving chemotherapy.
- Epogen/Procrit is indicated under the same guidelines after a patient has received chemotherapy for a minimum of 2 months.
- ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- ESAs should be discontinued following completion of a chemotherapy course of treatment.
There is one thing this FDA notice does not discuss: why blood transfusions are to be avoided. Many patient advocates believe that fear of transfusion has been overhyped. Still, the FDA's move is a huge step forward.
So survivors, let's send up a cheer, let's slap each other on the back. After that, we veterans and all the other new advocates who may just now realize how important advocacy is, must roll up our sleeves and get ready for the next battle with the FDA, because this wasn't the first and it won't be the last.
Additional information is available:
Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
Posted February 22, 2010.
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