By Amy Barrett Johnson & Johnson (JNJ) is in damage-control mode. On June 13 it announced the recommendations from a panel J&J had convened to evaluate its heart-failure drug Natrecor after questions mounted about the drug's safety.
The series of recommendations made by the panel, led by well known cardiologist Dr. Eugene Braunwald, includes urging the drugmaker to do a trial to answer the question of whether Natrecor may be linked to a higher death rate and what impact it has on kidney function (see BW Online, 4/20/05, "J&J's Heart Drug: Jolted Again").
A CONTROVERSIAL USE. "We are completely committed to answering those questions," says Dr. Darlene Horton, senior vice-president for clinical research and medical affairs at Scios, the J&J unit that developed the drug. She says the company is in the process of planning a large-scale trial along the lines recommended by the panel.
The panel's suggestions are "moves in the right direction," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic. But he adds: "This trial should have been done in 2001," when the drug was first approved. Safety concerns about the medication gained attention earlier this year when two medical journal papers raised questions about its impact on the kidneys and the possibility that it's tied to a higher death rate.
The panel also addressed a growing and controversial use of the drug. Natrecor was tested only in hospitalized patients who were suffering from an episode of severe shortness of breath. Those bouts are common for many patients with congestive heart failure. But a number of physicians have been using the drug in outpatient clinics. In many cases, those patients aren't suffering severe breathing problems, but physicians hope the drug may prevent such episodes in the future and keep them out of the hospital.
CRIMPING SALES. That sort of use wasn't approved by the Food & Drug Administration, however. But while companies cannot actively promote such "off-label" uses of their products, doctors are free to prescribe drugs in any way they think will benefit patients. Given the unanswered questions about Natrecor's safety and the effectiveness of such preventative treatment, the Braunwald panel specifically states the drug should not be used in that fashion. J&J says it will begin educating physicians about the panel's recommendations.
J&J hasn't exactly been discouraging off-label use (see BW, 4/25/05, "'Off-Label' Drugs: J&J Is Pushing the Envelope"). For example, the outfit has funded educational seminars for doctors that talk about weekly infusions of Natrecor, an off-label use. A J&J spokesman says the company has never promoted the drug for any unapproved uses.
The uproar over Natrecor is likely to crimp the drug's growth. Smith Barney analyst Matthew Dodds has cut his 2005 sales projection on the drug from $676 million to $530 million. The big question is whether the trial J&J is now undertaking will quiet its critics -- or provide hard evidence that the worries about Natrecor are well-founded. Barrett is BusinessWeek's Philadelphia bureau chief