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Obesity Drug Recall Ends MIT Royalties

By David D. Hsu
News Editor

With the recall of the obesity drug dexfenfluramine on Sept. 15, MIT lost a revenue source previously expected to bring in at least one million dollars per year in royalties.

Dexfenfluramine, commercially known as Redux, was voluntarily recalled after some patients using the drug developed heart valve damage.

The bulk of the research on the treatment of obesity with dexfenfluramine was conducted at MIT by Richard J. Wurtman, professor of neuroscience, and his wife Judith, a research scientist in the Department of Brain and Cognitive Sciences.

Since MITowns the patent on dexfenfluramine, the Institute received royalties, typically one to five percent of sales.

Sales of the drug in 1996 reached $132 million, according to The New York Times.

"We received more than one million dollars last year," saidLita Nelsen, director of the Technology Licensing Office.

After the Food and Drug Administration approved the drug in Nov. 1995, Wurtman said sales were expected to reach $600 million annually. One analyst had predicted $1 billion dollars in annual sales by 1999, according to The Boston Globe.

"This year, MITwill receive next to nothing" after the recall, Nelsen said.

However, royalties are not something MITdepends on, Nelsen said. Redux income was not used for general operations but rather for one-time costs.

Although the Institute is sorry that the money is gone, "it won't impact MIT in any noticeable way," Nelsen said.

Wurtman is waiting for more research on the drug's effect. "I don't know if there's any relationship between Redux and the cardiac symptoms simply because there hasn't been a controlled study," Wurtman said.

"I don't know if it's real or not," Wurtman said. He said he expects more information in a few months.

The recall occurred just over one year after the drug first went on sale in June 1996. A few months after Redux hit the market, Wurtman said the drug was identified as "the most successful new drug ever launched; over a million prescriptions have already been written."

The drug opened miracle-like expectations. Sheldon Levine, a diet doctor, even wrote The Redux Revolution, a book about the "most important weight loss discovery of the century."

Drug's safety questioned

Redux later graced the Sept. 23, 1996 cover of Time, but at that time, questions were already being raised about the drug's safety.

Minor side effects, like a dry mouth and fatigue, were noted. More serious side effects, like toxicity and hypertension, were cited by various studies.

Still, Redux managed to shrug off most of the bad publicity.

In July, the Mayo Clinic reported that 24 patients developed heart valve disease after taking a drug combination of fenfluramine and phentermine. Fenfluramine contains dexfenfluramine. There were also reports of cases of heart valve damage in patients taking only Redux.

The Mayo findings were reported in the Aug. 28 issue of the New England Journal of Medicine.

Later findings showed that of 291 patients screened, 30 percent had abnormal valve findings.

Based on the new data, manufacturers agreed to withdraw both Redux and fenfluramine, and the FDA recommended patients stop taking the drugs.

With the recall of Redux, questions have been raised about the FDA approval process. The FDA defends itself, saying that Redux labeling claimed that safety was not shown for longer than one year of use. In addition, dexfenfluramine had been marketed in Europe for over 10 years without displaying a link between the drug and heart valve problems.

Interneuron Pharmaceuticals, a company founded by Wurtman, licensed the patent and developed the drug. Wyeth-Ayerst Laboratories produced and marketed Redux.