publication date: Oct. 31, 2014

Past Coverage of Charles Bennett and the Northwestern University Settlement Case

 

ESAs Increase Risk of Death by 11 Percent, Blood Clots by 59 Percent, Meta-Analysis Finds; Study To Be Updated At ASCO

A recently updated meta-analysis of studies of erythropoiesis stimulating agents shows a statistically significant drop in survival and a rise in venous thromboembolism associated with the use of these agents in oncology.

 

Scientist’s Interpretation Of Meta-Analysis On ESAs Turns 180 Degrees Over 72 Hours

CHICAGO—Last week, Charles Bennett prepared to present a provocative and potentially important finding: According to his meta-analysis, patients who took erythropoiesis stimulating agents had a statistically significant increase in the relative risk of venous thromboembolism and death. 

 

Meta-Analysis Finds ESA Use In Oncology Associated With Increases In VTE, Mortality

A meta-analysis published in the Feb. 27 issue of the Journal of the American Medical Association found that the use of erythropoiesisstimulating agents in oncology is associated with statistically significant increases in venous thromboembolism and mortality

 

ODAC Meeting: Further Restrictions Likely On ESA Use; Changes Advocated by ODAC May Cut Market By 40-50 Percent

Last year, the companies that market erythropoiesis-stimulating agents could still argue before Wall Street analysts that chemotherapy-related anemia was largely undertreated and that the franchise would once again continue to expand.

 

FDA Orders More Changes In ESA Label, Agents Not Indicated In Curative Setting

FDA on July 30 ordered Amgen Inc. to change the wording of its label for Aranesp in a way that is likely to further restrict the use of the drug in treating cancer.

In ordering the drug sponsor to make the label changes, the agency invoked for the first time an authority provided in 2007. Previously, FDA could only negotiate label changes with sponsors.

 

Amgen Announces Cochrane Findings: ESAs Increase Risk Of On-Study Death

Something was missing from a press release announcing the Cochrane Collaboration’s preliminary result from a pooled analysis of ESA studies.

That something was comment from the investigators who conducted the patient-level meta-analysis. The only quote belonged to Roger Perlmutter, executive vice president for Research and Development at Amgen Inc., one of the three companies that provided the randomized trial data for the pooled analysis.

It was, in fact, Amgen that issued the press release about the Cochrane findings.

 

Northwestern Repays Government $3 Million To Settle Claims Over Use Of NCI Grants; Researcher Bennett Now Faces Feds Alone

Northwestern University agreed to pay the federal government nearly $3 million to settle a whistleblower lawsuit alleging that a prominent researcher whose work focuses on harm caused by cancer drugs had diverted NCI grant money for personal use.

Settling the lawsuit last week, the university said it would return the funds to the government, but admitted no wrongdoing in administering the grants obtained by Charles Bennett, an oncologist whose best-known work focused on overuse of erythropoiesis-stimulating agents.

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