Scios Sends Second "Dear Doctor" Letter On Heart Drug Natrecor
Cardiologist Eric Topol Calls For Limited Use of Johnson & Johnson Drug Natrecor
On July 13, 2005 the Scios division of Johnson & Johnson sent a second "Dear Doctor" letter about Natrecor, a heart-failure drug that has been the subject of an ongoing safety debate during the past several months. In May 2005 Scios sent out its first Natrecor Dear Doctor letter. The apparent purpose of this most recent letter to doctors is to explain the recommendations of an expert panel appointed by Johnson & Johnson and headed by Harvard cardiologist Eugene Braunwald. The expert panel's mission was to investigate what steps to take to address the current safety issues concerning Natrecor.
As has been discussed here previously, the controversy over Natrecor began with a series of medical journal articles which suggested that Natrecor use might have serious side effects, including kidney damage and increased mortality. Much of this drug-safety controversy has to do with Natrecor being given regularly to outpatients, an "off-label" use.
According to this second Natrecor Dear Doctor letter, the expert panel has recommended that J&J undertake several clinical trials, including a large trial to assess the risks and benefits of Natrecor. Further, this panel recommended that Natrecor should only be used in the hospital, and made clear that Natrecor should not replace the use of diuretics as the first-line treatment for acute decompensated heart failure.
Recently, cardiologist Eric Topol, of the Cleveland Clinic, in a July 2005 article published in The New England Journal of Medicine (NEJM) article, was very critical about any use Natrecor beyond its approved indication as a treatment for heart failure. Dr. Topol's NEJM article went so far as to imply that perhaps Natrecor should not be available for use until more is known about its safety. "In my view, [Natrecor] has not yet met the minimal criteria for safety and efficacy," wrote Dr. Topol; accordingly, he points out, until J&J conducts a sufficient drug-safety trial, questions will remain about whether Natrecor should even be available for use in the U.S.
Some may recall that Dr. Topol was one of the most prominent, and vocal, critics of Merck's Vioxx as well as Pfizer's Bextra before each of those arthritis drugs were pulled from the U.S. market.
(Posted by: Tom Lamb)
