24. Epilepsy Drug Fiasco Ignored by Press

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Source: Personal letter and documents, Date: 10/11/94, Author: Stephen Bertman

SYNOPSIS: On August 2, 1993, the Food and Drug Administration (FDA) approved the first new epilepsy drug in more than ten years. The approval was announced with considerable fanfare at a press conference held at the National Press Club Ballroom in Washington, DC. On August 4, The New York Times reported that the drug, felbamate, will be used to prevent partial seizures in adults. The Times noted that some 2.5 mil­lion Americans have epilepsy, a chronic brain disorder that can cause seizures, and 125,000 new patients are diagnosed each year.

The FDA said that in clinical trials, felbamate reduced the fre­quency of seizures and had min­imal side effects. (Emphasis added.) David A. Kessler, the Commissioner of Food and Drugs, said “Felbamate provides a new weapon against the debilitating effects of epilepsy.” The Times reported that Wallace Labs of Cranbury, N.J., would market the new drug under the brand name Felbatol. It quoted the company as saying “An estimated 500,000 to 700,000 epilepsy patients suffer seizures that cannot be controlled by current medications.”

Just a year later, on August 2, 1994, The New York Times pub­lished a seven-column-inch story headlined “Carter-Wallace Stock Falls.” The lead paragraph read: “Carter-Wallace Inc.’s shares plum­meted yesterday, losing nearly a third of their value, after the com­pany warned doctors to quit treating patients with an epilepsy drug linked to two deaths.” The story then reported that the manu­facturer sent letters to some 240,000 doctors recommending that patients discontinue taking the drug, Felbatol, then went on to discuss the impact this action would have on Carter-Wallace shares and sales.

A Wall Street Journal (WSJ) article, also published August 2, 1994, was headlined “Carter­Wallace Stock Plummets as FDA Warns Against Firm’s Epilepsy Drug.” The WSJ article reported that “The (Felbatol) drug is the third Carter-Wallace pharmaceu­tical product hit by regulatory action this year. Production of Organidin, an expectorant, was halted in June after the FDA had raised concerns about its safety last year. In April, the company ended production of Deprol, an antide­pressant, after the FDA withdrew its approval because it lacked evi­dence of efficacy.” Organidin and Felbatol were the company’s two biggest-selling drugs, representing about a third of its health-care sales of $296.6 million in the last fiscal year.

On October 5, 1994, in a follow-­up story, The New York Times reported that Carter-Wallace was virtually abandoning all its drug research. It also noted that since the FDA approved the drug for the market, six people using Felbatol have died-four from blood disor­ders and two others of liver failure.

This story was submitted to Project Censored by Stephen Bertman, of West Bloomfield, Michigan. Aware of a patient who suffered multiple grand-mal seizures and other serious side effects, following withdrawal from Felbatol on her doctor’s advice, Bertman attempted to research the issue and found “Except for articles in The Wall Street Journal and on the financial (!) pages of The New York Times, the story and, in partic­ular, its tragic human impact have remained unreported.”

Project Censored researchers confirmed the limited coverage.

SSU Censored Researcher: Dave Lake

COMMENTS: Stephen Bertman, who originally brought this story to the attention of Project Censored, said, “The story received only min­imal coverage in terms of the human cost of what had happened and who was responsible. There were no follow-ups on victims; no coverage whatsoever of withdrawal causing grand-mal seizures.”