FDA Approval of Obesity Drug Could Bring Institute Millions
Richard J. Wurtman
By A. Arif Husain
Associate News Editor
In a decision last night that could bring five to eight million dollars in royalties to the Institute, a Food and Drug Administration advisory committee approved the national use of an MIT-patented drug for the treatment of obesity.
Sales of the drug, dexfenfluramine, are expected to reach $600 million annually, said Professor of Neuroscience Richard J. Wurtman, who was involved in its early development.
"This is the first time any drug has been approved for the long term treatment of obesity," Wurtman said. The drug can be administered for a year or longer, and no side effects have been observed.
The drug acts by increasing levels of a brain chemical called serotonin, which is involved in appetite control. By raising serotonin levels, researchers found that people reduce their carbohydrate intake and subsequently lose weight.
Wurtman's wife Judith, a research scientist in the Department of Brain and Cognitive Sciences, laid the scientific groundwork for the discovery in the late 1970s by observing that many obese people suffer from a condition known as carbohydrate craving, which is characterized by an abnormally high carbohydrate intake. Research showed that the consumption of carbohydrates raises serotonin levels, leading to the idea that dexfenfluramine, which produces a similar effect, could be used as a potential treatment.
The chemical compound of dexfenfluramine was discovered about 40 years ago, but the work that led to its use as a treatment for obesity "was all done at MIT," Wurtman said.
The FDA's approval of the drug yesterday is an acknowledgement that obesity is a serious disease which requires treatment, Wurtman said. "There are a lot of people who need a drug for it -- the same way there are a lot of people with high blood pressure who need a drug for that," he said.
"This drug could have as much of an impact on obesity and the diseases obesity causes like diabetes, as the high blood pressure drugs have had on strokes," Wurtman said.
Dexfenfluramine has been in use in 65 other countries for many years. Over 12 million people having taken it for obesity treatment. The French company Sevier, which has been marketing it, does not have a branch in the United States, so Wurtman founded the company Interneuron Pharmaceuticals in 1988.
The company operates without any of its own research or manufacturing facilities. Instead, it outsources contracts to other companies and laboratories.
With yesterday's FDA approval, production of the drug will be licensed to the pharmaceutical-giant Wyeth Laboratories, which does 12 billion dollars in annual sales worldwide, Wurtman said. Negotiations must now begin to resolve labeling and marketing issues, but the drug could be available to consumers in as early as three to six months.
The advisory board's majority vote followed an unsettled decision at a first failed meeting several weeks ago.
"I am very, very happy about [the approval]. I think it will have a major impact on public health in America," Wurtman said.