The JAMA article elicited impassioned responses from blood-substitute companies that now find themselves in dire straits—falling stock prices, clinical trials in limbo and a barrage of negative press. A. Gerson, Greenburg, Cambridge, Massachusetts–based Biopure's vice president for medical affairs, fired off a letter to JAMA's editors insisting the meta-analysis unfairly lumped the company's data with those from other firms, generating results he says aren't relevant to Biopure's own products. In response, Natanson claims the evidence for heightened risk of death and heart attack from the collective data is “overwhelming,” and insists clinical testing should have been halted long ago.
The JAMA publication coincided with a two-day meeting cosponsored by the US Food and Drug Administration (FDA) and attended by nearly 350 people, including company representatives. At the meeting, agency officials concurred that current blood substitutes produce excess mortality and heart attacks. “For this reason, a careful weighing of potential risks and benefits will be needed to permit any future trials of the current products,” writes Jay Epstein, director of the FDA's Office of Blood Research and Review, in an e-mail to Nature Biotechnology.
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