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Redux Treats Obesity, May Generate SIde Effects

By May K. Tse
Associate News Editor

After spending 20 years studying obesity and its relation to chemicals in the brain, the work of Richard J. Wurtman, professor of neuroscience, and his wife Judith, a research scientist in the Department of Brain and Cognitive Sciences, has finally paid off.

Dexfenfluramine, a drug commercially known as Redux, first went on sale this June. Since it has only recently been released, figures about its eventual worth aren't in yet, but the popular drug has been identified as "the most successful new drug ever launched; over a million prescriptions have already been written," Wurtman said.

While Redux recently graced the Sept. 23 cover of Time, there have been doubts of the drug and suspicions that it causes negative side effects. But the side effects have been mild "among the 12 million people that have taken the drug in Europe, where it was approved six to eight years ago," Wurtman said.

Eating affects brain chemicals

The groundwork for the discovery of dexfenfluramine began in the early 1970s, when Wurtman discovered that eating affects chemicals in the brain, which were later identified as serotonin.

Then his wife Judith later discovered that many obese people had what she called "carbohydrate cravings"late at night which forced them to snack. These late-night snacks served as a sort of antidepressant which increased serotonin levels in the brain. Richard and Judith Wurtman came up with the idea of a drug which would mimic the effects and would help obese people reduce their amount of late-night snacking.

Redux should not be labeled as a diet pill, Richard Wurtman said. "Obesity kills 300,000 a year, and that's what the drug is for."

Report cites possible side effects

There are minor side effects that are associated with dexfenfluramine, Richard Wurtman said.

"Some people get a dry mouth, which lasts for a couple of weeks," Wurtman said. "Because of this, some might drink more, so they might have frequent urination."

Another side effect is fatigue, which causes the users to take half dosages for awhile, Wurtman said.

Other more serious side effects, like toxicity and hypertension, have been cited by various studies.

There are suspicions that high doses of dexfenfluramine may be toxic to nerve cells, Wurtman said. However, there is "absolutely no evidence whatsoever that the drug is toxic at any dose in any species."

Enormously high dosages of dexfenfluramine will decrease the level of serotonin in the brain, but this is not associated with any functional consequences in people or animals, Wurtman said. The amount of dexfenfluramine that causes the decrease is at least 10 times the amount taken by people to treat obesity.

Since the drug is not a stimulant and has no addictive potential, people don't take the pills for the fun of it, Wurtman said.

Recent studies alleged that people taking any anti-obesity drug had a 10- or 20-fold greater risk for primary pulmonary hypertension, an extraordinarily rare disease that occurs in one or two people in a million, Wurtman said. Obesity by itself doubles the risk to get the disease, so if someone loses weight, then he loses the risk to get hypertension.

MIT to earn royalties

Redux is the first weight-loss drug approved by the Food and Drug Administrationin 23 years and is grossing high revenues very quickly. The stock for Interneuron Pharmaceutical, the company co-founded by Wurtman which licensed the patent and developed the drug, is already worth up to roughly $28 million.

"Even if it was never approved by the FDA, it would still be worth [the effort] because we found a creative new way of thinking about why people gain weight," Judith Wurtman said.

Since MITowns the patent on dexfenfluramine, "MITwill receive perhaps something on the order of $2 million for a limited period of time,"said Lita Nelsen, director of the Technology Licensing Office, "MITtypically receives 1 to 5 percent of sales for royalties."

The two biggest royalties MIThas ever received on patents grossed close to $25 to $30 million back in the 1960s and 1970s.

Dexfenfluramine "could match [them] if demand keeps up and continues to grow for a period of several years," Nelsen said.

MIT to receive melzone patent

Another patent which MITwill soon be receiving royalties on is Melzone, a dietary supplement used to aid sleep which was based on another research Wurtman did with melatonin, another chemical in the brain. It is due to premiere in drugstores within a few weeks.

"It's an over-the-counter drug which will probably pay smaller amounts of money in royalties but for a longer amount of time since its patent lasts longer than Redux's,"Nelsen said.

The stroke drug citicoline, based on another of Wurtman's research, is currently undergoing testing for FDAapproval. If approved, the drug could become the next big hit.

"Iwill be proudest of this drug because it will be the first safe drug ever [found] for treating stroke," Wurtman said. He hopes that the drug, if it is found to be proven to work in the studies, will be available in a few short years.

Although the drug could have the potential to gross even more than Redux, it's not a particular concern to MITif it doesn't. "A million dollars looks like a lot but it's not when it's only one-tenth of 1 percent of MIT's income,"Nelsen said.

However, even without the lure of money, Wurtman is excited about his work. "I didn't do research to cure diseases but to understand the brain and the control of its inputs," he said.

"My driving force all these years has been curiosity," Wurtman said. "Plus, it's wonderful to discover something new, because it can only be discovered once."