On July 19, the Washington Post published an investigative article alleging that Amgen and Johnson & Johnson overstated the benefits of the anemia drugs Epogen (epoetin alfa), Procrit (epoetin alfa), and Aranesp (darbepoetin alfa) while overlooking the potentially lethal side effects of these medications.

Epogen, Procrit, and Aranesp belong to a class of drugs known as erythropoiesis-stimulating agents (ESAs) that are approved for the treatment of anemia (low red blood cells) resulting from chronic kidney failure, chemotherapy, certain treatments for HIV, and also to reduce the number of blood transfusions during and after certain major surgeries. ESAs carry a black box warning stating that they increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and increase the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

The Washington Post article alleges that millions of patients had been subjected to dangerous doses of these ESAs that might have had little benefit. The drug companies allegedly marketed higher doses of ESAs for a wide variety of illnesses, despite evidence linking higher doses of ESAs to an increased risk of mortality.

In a statement, Amgen responded that ?Any assertion that Amgen misled the public about the risks and benefits is a gross misstatement of the facts. On the contrary, Amgen?s primary concern is for patients.?

Johnson & Johnson stated ?As our understanding of the risk-benefit profile of [the drugs] has evolved over time, we have worked closely with the FDA to ensure new and relevant information is included in labeling.?

Analysis:

Manufactured by Amgen, Epogen (epoetin alfa) was FDA approved in 1989. Procrit (epoetin alfa) was licensed by Johnson & Johnson and also approved in 1989. Aranesp (darbepoetin alfa) was FDA approved in September 2001 and is manufactured by Amgen.

Using data from AERS, from 01/01/2004 to 03/31/2012, aggregated and standardized by the AdverseEvent RxFilter process, we identified 18,582 patients who experienced a serious adverse event where Epogen, Procrit, or Aranesp was identified as a suspect drug causing the event and 7,124 patients who experienced a serious adverse event where Epogen, Procrit, or Aranesp was identified as the primary suspect.

The most commonly reported side effects were decreased therapeutic response, pure red cell aplasia, and death. We identified 2,109 hospitalizations and 828 patient deaths where Epogen, Procrit, or Aranesp was identified as the primary suspect.

We identified 2,178 patients, from 01/01/2004 to 03/31/2012, who experienced a serious adverse event involving cardiovascular disorders, cerebrovascular accidents, or neoplasm progression where Epogen, Procrit, or Aranesp was identified as the primary suspect.

Note: In order to calculate the number of adverse event cases involving cardiovascular disorders, cerebrovascular accidents, or neoplasm progression, we aggregated reports for patients reporting the following conditions at the time of the adverse event: MedDRA Preferred Term: Neoplasm progression, MedDRA High-Level Term: Central nervous system haemorrhages and cerebrovascular accidents, and MedDRA System Organ Class: Cardiac disorders, Vascular disorders.

This analysis does not take into account the number of patients taking each medication.