FDA Reviewing Anemia Drugs Again
Featured ArticleMain Category: Blood / Hematology
Also Included In: Cancer / Oncology; Regulatory Affairs / Drug Approvals
Article Date: 04 Jan 2008 - 2:00 PDT
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The US Food and Drug Administration (FDA) said it is reviewing new data on the risks of a type of anemia drug called ESAs, erythropoiesis-stimulating agents.
The evidence comes from two studies that found patients with breast or advanced cervical cancer who were given ESAs for chemotherapy-induced anemia died earlier or their tumours grew faster than similar patients who did not take ESAs.
The FDA advised stronger warnings for ESA use with cancer patients in November last year following the evidence of six studies giving similar results. These two new studies were not among them.
According to the FDA, all 8 studies, when viewed together, show patients with certain types of cancer die earlier and have faster tumour growth when they are given ESAs compared to patients who do not take the drugs. The particular types of cancer are: breast, non-small cell lung, head and neck, lymphoid and cervical.
The ESAs were given in order to help the patient get to a a hemoglobin level of 12 g/dL (grams per deciliter) or more, but, said the FDA, many of them did not get to that level.
The FDA is planning to hold a public advisory committee meeting within the next few months to go through the evidence and discuss the risks and benefits of ESAs for patients with chemotherapy-induced anemia.
FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, Dr Janet Woodcock said the new data:
"Further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications."
"FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients," she urged.
ESAs are an artificial version of a protein that occurs naturally in the kidney and triggers the bone marrow to make more red blood cells.
Doctors measure patients' hemoglobin (an iron-rich protein in red blood cells that carries oxygen) to find out how anemic they are and decide whether to prescribe ESAs.
ESAs are approved by the FDA for treatment of anemia in patients with chronic kidney failure and chemotherapy-induced anemia. They are also FDA approved for treatment of HIV patients whose anemia is caused by the drug AZT (zidovudine) and to reduce the number of transfusions needed either during or after major surgery.
The FDA has approved three ESAs: Aranesp, Epogen, and Procrit, all made by Amgen, who are based in Thousand Oaks, California. Procrit is also marketed and distributed by a subsidiary of Johnson & Johnson called Ortho Biotech LP who are based in Bridgewater, New Jersey.
The first of the two new studies was given to the FDA by Amgen on 30th November last year. This study, called the PREPARE study, included 733 women who had been treated with chemotherapy before having surgery for breast cancer. The trial compared patients who were given Aranesp for anemia with patients who did not take the drug.
After 3 years 14 per cent of the Aranesp patients had died compared to 9.8 per cent in the non-Aranesp group. The tumours of the Aranesp patients also grew faster.
Amgen gave the FDA the results of the second study on 4th December. This study was part of the National Cancer Institute's Gynecologic Oncology Group, where patients received chemotherapy and radiation therapy for advanced cervical cancer.
These patients were either given Procrit to reach a hemoglobin count of 12 g/dL or more, or they were given blood transfusions.
After 3 years, 58 per cent of the Procrit group were alive, compared with 66 per cent of the non-Procrit group.
Click here for FDA.
Sources: FDA ongoing safety review communication.
Written by: Catharine Paddock
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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What Do We Do About The Anemia Drug Controversy?
posted by Gregory D. Pawelski on 5 Jan 2008 at 10:04 amMost doctors and patients would agree the drugs are very helpful for patients when used to correct "severe" anemia, which can be debilitating and even life-threatening. The drugs reduce the need for somewhat risky blood transfusions and can give patients more energy and improve their quality of life.
''These are drugs that were presumed to be entirely safe, given for supportive care and to improve quality of life,'' not to actually treat cancer, said Dr. Eric Winer, director of breast oncology center at the Dana-Farber Cancer Institute in Boston. ''So any concern that they could shorten someone's life are taken quite seriously.''
There is little evidence that the drugs make much difference for patients with "moderate" anemia. Anemia is measured by a patient's level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic. The labels on the drugs approved by the FDA encourage doctors to aim for a hemoglobin level of 10 to 12.
Critics of the drugs say their increased use has been driven by profit. According to Dr. John Glaspy, director of UCLA's Outpatient Oncology Clinic, one complicating factor is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors' decisions.
Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, told UPI last year that "probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs." A six-month course of treatment can cost more than $10,000 per patient.
After this issue had started to be reported, U.S. Oncology took an 8-10 million dollar hit in its first-quarter SEC report last year, including reduced pre-tax income due to lower use of anemia drugs. They also were handicapped by CMS stopping the Medicare Demonstration Project which paid chemotherapy providers $130 per report, per infusional-chemotherapy recipient, on a patient's level of nausea, vomiting, pain and fatigue, something that Congress found out that they were supplying free of charge anyway.
A continuance of the Medicare Demonstration Project would have exacerbated existing economic and clinical problems instead of resolving them by increasing the temptations for physicians to overuse injectable drugs and promise to aggravate the economic problems Congress attempted to fix with the new Medicare law.
A New York Times article reported last year that Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. However, companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. Doctors receive the rebates after they buy the drugs from the companies, but they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price.
Although the new Medicare bill tried to curtail this kind of drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let's take physicians out of the retail pharmacy business and let them be doctors again!
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