Charles L. Bennett, MD, PhD | Authors

Reassessments of ESAs for Cancer Treatment in the US and Europe

March 15, 2010

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 < 10 g/dL. In the United States, ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) recommended that ESA benefits do not outweigh risks. In Europe between 2001 and 2006, ESA use increased 51%; since 2006, use decreased by 10%. In 2009, Canadian manufacturers recommended usage based on patient preferences. In Canada in 2007, approximately 20% of anemic cancer patients received ESAs, a 20% increase since 2004. In contrast to Europe, where ESA use has increased over time, reassessments of ESA-associated safety concerns in the United States have resulted in marked decrements in ESA use among cancer patients.

ACS spends big money to highlight healthcare system deficiencies

October 02, 2008

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.

Oncologic drug safety: Separating fact from fiction

August 01, 2008

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.

Comment: Research, regulatory trends suggest ESAs should play declining role in patient care

May 01, 2008

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.

Is the accelerated FDA approval pathway decelerating?

April 01, 2008

In 1992, FDA established accelerated approval (AA) regulations to allow patients with HIV and other life-threatening diseases rapid access to therapeutics.

Dermatologic Challenges in Cancer Patients and Survivors

November 01, 2007

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.

Cost Considerations in the Management of Cancer in the Older Patient

June 01, 2007

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

April 01, 2007

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?

November 01, 2006

Enrollment in clinical trials is crucialto continued scientific discovery andimproved patient care.

Government Agencies and Pharmaceutical Industry Must Take Action to Thwart Sales of Counterfeit Drug Products

September 01, 2006

With the lure of large profits, low arrest risk, and relatively light sentences, it is no wonder that criminals are trafficking in counterfeit pharmaceuticals.