Deadly Monopolies by Harriet A. Washington

Author:Harriet A. Washington [Washington, Harriet A.]
Language: eng
Format: epub
ISBN: 978-0-385-53405-5
Publisher: Knopf Doubleday Publishing Group
Published: 2011-10-03T16:00:00+00:00

PolyHeme on Trial

After conducting several small “test-run” clinical trials, Northfield commissioned a larger 1998 multicenter hospital trial, the Acute Normovolemic Hemodilution investigation, nicknamed the ANH study. Northfield convinced the hospitals and the FDA to allow it to investigate whether infusions of PolyHeme would safely allow the use of less donated blood during surgery. In this experiment, PolyHeme was infused into subjects awaiting surgery at institutions such as the University of Kentucky to repair an abdominal aortic aneurysm, a ballooned, weakened area in the artery wall that could burst at any time, causing massive, frequently fatal, hemorrhaging.

Two measures would have signaled success in the ANH study: the ability to use less, or no, donated blood during surgery, and more important, no higher a rate of adverse events, complications, or deaths when using PolyHeme than with blood. However, its Data Safety Monitoring Committee, an independent panel of experts that scrutinizes the safety and efficacy of an ongoing clinical trial, detected differences in the health status of the PolyHeme and control groups and asked for an in-depth analysis. This revealed that 54 percent of the patients who received PolyHeme suffered serious adverse events, ranging from heart-rhythm disturbances to pneumonia to heart attacks, but only 28 percent of patients who received blood suffered such problems. The results generated serious concerns about PolyHeme’s safety, concerns that were realized when ten of the eighty-one PolyHeme subjects died, in contrast to only four of those who had received blood. The difference was statistically significant, meaning that it was unlikely that it could have arisen by chance.

Northfield responded to these safety alarms by quietly closing the trial in early 2001. Its CEO, Stephen Gould, duly reported the excess morbidity and mortality to the FDA as was legally required, but he attributed it to putative disparities in the physical condition of the subjects. He also claimed that the doctors had bungled the study by infusing subjects who received PolyHeme with excess fluids.

In the wake of the ANH study, time was running out for PolyHeme. Its patent window was good for only about twenty years, and the longer it took Northfield to procure FDA approval, the greater the chance a competitor might emerge and the less time the company might have to enjoy any exclusive profits from its sale. A successful clinical trial was necessary for FDA approval, but the informed-consent process required that Northfield disclose to potential subjects the elevated rates of heart attack and death that dogged recipients of PolyHeme in the ANH trial. The revelation of these adverse effects would have made recruiting the necessary hundreds of subjects extremely difficult.

But Dr. Gould was an invitee to FDA meetings on the subject of HBOCs, where he presented the virtues of PolyHeme, including detailed technical arguments that fluid mismanagement and the profoundly ill condition of some subjects were to blame for the ANH medical disasters, not PolyHeme. These presentations apparently bolstered his arguments on behalf of PolyHeme enough for Northfield to convince the FDA to allow it to exploit the 50.

Download

Copyright Disclaimer:
This site does not store any files on its server. We only index and link to content provided by other sites. Please contact the content providers to delete copyright contents if any and email us, we'll remove relevant links or contents immediately.