Cleveland Clinic Panel Gives Heart Failure Drug a Reprieve

The Cleveland Clinic gave an apparent reprieve to a controversial Johnson & Johnson heart failure treatment yesterday when a committee overruled more than four dozen of its cardiologists by deciding that the drug, Natrecor, would remain in use at the clinic.

The panel, composed of doctors from various disciplines, overruled the recommendation of about 50 members of the clinic’s cardiovascular medicine department, who had voted last week to ban or severely restrict use of Natrecor after two studies in medical journals indicated that it increased the risk of kidney impairment and death.

The panel’s vote is not binding, but a clinic spokeswoman said the decision would very probably be approved when reviewed by the full committee that determines what drugs are used at the clinic.

The issue appeared to be steeped in organizational politics at the clinic, one of the country’s largest and most prestigious heart treatment centers. The spokeswoman, Angela Calman, said the Natrecor matter had divided the clinic into “camps.”

The physician who would normally have been chairman of yesterday’s panel is Dr. James B. Young, the Cleveland Clinic’s chief of medicine. But Dr. Young recused himself because of his close ties to Natrecor. He had served as the lead clinical investigator on a pivotal Natrecor study that led to the drug’s federal approval in 2001.

The doctor who had raised the Natrecor issue was Dr. Eric J. Topol, the clinic’s chief of cardiovascular medicine. Dr. Topol’s questions about Natrecor’s safety and cost led to the cardiologists’ vote last week.

What I could not glean from the article was the definition of the problem. Did this relate to standard or non-standard use of Natrecor? Clearly, we must look carefully at any such medication. Natrecor’s usage makes physiologic sense – but apparently there are some problems.

The controversy over Natrecor arose this year with the publication of two studies in medical journals that seemed to indicate it was linked to death and decreased kidney function. The lead investigator on both those studies, Dr. Jonathan D. Sackner-Bernstein of North Shore University Hospital in Manhasset, N.Y., has since asked that Johnson & Johnson make a broad study of the drug.

The company asked a noted cardiologist, Dr. Eugene Braunwald of Harvard Medical School, to convene a panel to evaluate the drug. The Cleveland Clinic committee indicated yesterday that it would look at Dr. Braunwald’s findings when they become available.

So I had to find at least one of the articles. The one I found is a meta-analysis. As is true for most meta-analyses, one must classify the results as hypothesis generating.

Their conclusions:

Compared with noninotrope-based control therapy, nesiritide may be associated with an increased risk of death after treatment for acutely decompensated heart failure. The possibility of an increased risk of death should be investigated in a large-scale, adequately powered, controlled trial before routine use of nesiritide for acutely decompensated heart failure.

Reference: Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure

The Medscape synopsis of the article – Nesiritide Linked to Higher Posttreatment Mortality Risk in Heart Failure

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