August 2005 | Hightower Lowdown
A Deadly Prescription
By Jim Hightower
Prepare to be repulsed by the story of Propulsid. The drug has been very, very good for its maker, Johnson & Johnson, which has reaped more than a billion dollars a year from Propulsid sales. But it has been way less than good for patients. First approved in 1993 to treat nighttime heartburn in adults, the drugmaker’s sales staff pushed doctors to prescribe it for far wider uses, including for babies’ acid reflux problems. The corporation never had FDA approval for these broader uses, and it turns out that the drug was ineffective as a treatment for them—a fact that Johnson & Johnson honchos knew early on from their own studies, but chose to keep a secret from doctors and patients.
Meanwhile Propulsid was creating big problems for many unwitting patients who learned the hard way that the drug can interfere with the heart’s electrical system. Hundreds of Americans—including babies—have died, and tens of thousands have suffered heart damage from taking Propulsid. Not only did the corporation know of these deadly side effects, but so did FDA regulators. The agency is so weak, however, that it can’t even require a warning label on the drug—it has to negotiate wording with the drugmaker, a secret process that takes months... and people’s lives. In 1998, Johnson & Johnson bean counters calculated that proposed FDA label warnings about heart damage could cost the corporation $250 million a year in sales, so the company scuttled the warnings.
Finally, the FDA scheduled a public meeting with outside experts on the safety of Propulsid. To avoid public exposure of the drug’s long-hidden and ugly history, Johnson & Johnson withdrew it from the market only three weeks before the meeting, which the FDA then cancelled.
This is a case of drug executives profiteering at the expense of human life—and of a regulatory system so enfeebled by deregulation ideologues that it cannot protect our public health.
©2005 Jim Hightower and Associates. Jim Hightower is a columnist and author. Visit www.jimhightower.com.
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