Anemia is a widely prevalent complication among cancer patients. At the time of diagnosis, 30% to 40% of patients with non-Hodgkin lymphoma or Hodgkin lymphoma and up to 70% of patients with multiple myeloma are anemic; rates are higher among persons with myelodysplastic syndromes. Among patients with solid cancers or lymphomas, up to half develop anemia following chemotherapy. For almost 2 decades, erythropoiesis-stimulating agents (ESAs) were the primary treatment for cancer-related anemia. However, reassessments of benefits and risks of ESAs for cancer-associated anemia have occurred internationally. We reviewed guidelines and notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and chronic kidney disease settings within the United States, Europe, and Canada. In 2008 the US Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to hemoglobin levels
Charles L. Bennett, MD, PhD
With the race for the presidency in full swing, the American Cancer Society (ACS) is taking a leading role in increasing the nation’s focus on the country’s ailing health care system.
Annually, adverse drug reactions (ADRs) result in costs of $3.6 billion and 140,000 deaths.1 Yet in 2005, only 15,107 reports of fatalities linked to potential drug toxicity were reported to the US Food and Drug Administration.2 This low number suggests that, despite significant morbidity and morality, ADRs remain underappreciated by clinicians. This is particularly troublesome when it comes to ADRs associated with oncology drugs.
A new meta-analysis showing an increased mortality risk with ESAs, combined with new laboratory data on the mechanisms of ESA toxicity, may cause clinicians, and FDA, to re-think their use.
In 1992, FDA established accelerated approval (AA) regulations to allow patients with HIV and other life-threatening diseases rapid access to therapeutics.
The increased approval of anticancer agents has led to unprecedented results, with improved quality of life and longer survival times, resulting in millions of individuals living with a diagnosis of cancer. Whereas these novel medical, surgical, and radiation regimens, or combinations thereof, are largely responsible for these remarkable achievements, a new, unexpected constellation of side effects has emerged. Most notably, cutaneous toxicities have gained considerable attention, due to their high frequency and visibility, the relative effectiveness of anti–skin toxicity interventions, and the otherwise decreasing incidence of systemic or hematopoietic adverse events. Optimal care dictates that dermatologic toxicities must be addressed in a timely and effective fashion, in order to minimize associated physical and psychosocial discomfort, and to ensure consistent antineoplastic therapy. Notwithstanding the critical importance of treatment-related toxicities, dermatologic conditions may also precede, coincide, or follow the diagnosis of cancer. This review provides a basis for the understanding of dermatologic events in the oncology setting, in order to promote attentive care to cutaneous health in cancer patients and survivors.
This paper provides an overview of several prominent articles and empirical studies on supportive care and cancer-related costs faced by older cancer patients. It focuses primarily on individuals 65 years of age and over and reviews several types of cancer.
$25 Million Patient Navigation Program Aims to Reduce Cancer Health Disparities in Targeted Communities
On June 29, 2005, President Bush signed into law the Patient Navigator Outreach and Chronic Disease Prevention Act of 2005 (H.R. 1812). This legislation authorized the National Cancer Institute (NCI) to oversee the distribution of $25 million in competitive 5-year grants to help underserved communities access health care services.
Reporting Only ‘Unanticipated’ AEs of Trial Drugs Would Reduce IRB Workload, But Would Patient Safety Suffer?
Enrollment in clinical trials is crucial
to continued scientific discovery and
improved patient care.
Government Agencies and Pharmaceutical Industry Must Take Action to Thwart Sales of Counterfeit Drug Products
With the lure of large profits, low arrest risk, and relatively light sentences, it is no wonder that criminals are trafficking in counterfeit pharmaceuticals.