FDA Knew About the Dangers of Redux but Approved it Anyway
By Will Block

ichard Wurtman, M.D., the renowned Massachusetts Institute of Technology neuroscientist, has been one of the driving forces behind FDA's approval of dexfenfluramine (Redux), and, not surprisingly, one of its chief profiteers. He is a major shareholder in Interneuron Pharmaceuticals Inc., a Massachusetts-based company to which the patent for Redux is licensed.

Curiously, when the FDA advisory committee first convened to consider the approval of Redux, the drug was rejected because of concern for its adverse effects, some of which, like permanent brain damage and pulmonary hypertension, were considered dire, even life-threatening. At this initial FDA meeting, the vote was 5-3 against the approval of Redux based on its safety.1 The session was characterized as "stormy" with three of the committee's eight members walking out in protest.

But strangely, a couple of months later the FDA convened a reconstituted panel, and Redux squeaked through on a 6-5 vote.2 For this new panel the FDA took an unusual position: it recommended approval of Redux!

Redux was Interneuron's first new drug, and the first new US diet pill in more than 20 years. Upon news of the FDA's action, Interneuron's stock price soared more than 24%.1 Back in April 1995, Wurtman's stock holdings in Interneuron were estimated to be worth $7 million.3 At that value, the FDA approval put an added $1.68 million in Wurtman's pocket.

Shortly after the approval of Redux, media coverage on the new drug was all positive, and Professor Wurtman was flying high. "The Advisory Committee's recommendation is a milestone, not only in the FDA's review of Redux, but also in the history of obesity therapy in the US," said Dr. Glenn L. Cooper, president and chief executive of Interneuron. Moreover, he added, "Redux is now positioned to become the first obesity drug approved for long-term use in this country."

Kelly Brownell, a Yale University psychologist and weight-loss researcher said, "Drugs are here to stay. We went through a down period of about 15 years when people didn't consider drugs for use in obesity because of the amphetamine experience. But now we have a new generation of drugs that can potentially be quite helpful in losing weight."

Things weren't always so rosy for Richard Wurtman. Back in the early 1980s, he had taken a consulting role in the evaluation of aspartame, (the dietary sweetener sold as NutraSweet, initially supporting its role in nutrition. Aspartame is comprised of the amino acid L-phenylalanine (LPA) and aspartic acid. Six years later, though, Wurtman changed his mind, claiming that the Nutrasweet Company was ignoring the possibility that large amounts of LPA could cause problems in some people. His consultancy over, presumably because NutraSweet could not abide his criticism, Wurtman testified against the product, claiming that at extremely high levels, LPA can be toxic to the brain. Discounting his testimony, the FDA went ahead and approved aspartame. According to a representative for G.D. Searle, the parent company of NutraSweet, Wurtman's criticisms were just politics. But maybe there was something more.

During the 1980s, Wurtman was also busy filing patents for the use of various amino acids to treat mood disturbances, suppress appetite (several of his formulations included ephedrine), fight addiction, control PMS, regulate blood pressure, depression, elevate mood, decrease fatigue, and combat the aging process. It is extremely interesting that some of his patents involve the use of LPA at levels far greater (5-200 mg/kg body weight) than a person could possibly ingest through even an enormous consumption of aspartame-sweetened soft drinks. Could Searle have been right? When Wurtman turned against aspartame, was he really defending the public, or was he really looking out for his own interests?

In 1991, despite the FDA's disagreement with his earlier statements about the use of amino acids, Wurtman was chosen by the agency as their chief expert witness before a congressional subcommittee investigating tryptophan contamination. He advocated that amino acid supplements currently being sold as nutritional supplements be reclassified as drugs.4 About LPA, he said that it was a dangerous substance that should not be allowed to be sold. He also stated, despite much evidence to the contrary, that LPA could not be converted (in the brain or body), into noradrenaline, the brain's version of adrenaline.

What Wurtman did not reveal in his testimony was his conflict of interest. He had received, or had pending, approvals on 37 use patents for various amino acid formulations, including one for LPA (US Patent #947208) to do what he had denied was possible: convert LPA to noradrenaline. Not incidentally, at about the same time that tryptophan was banned, the enormously profitable SSRIs, including Prozac and the rest, appeared. While Wurtman did not appear to profit from the SSRIs, Redux was yet to come.

A story about melatonin in a 1995 issue of USA Today reported that Interneuron Pharmaceuticals Inc. of Lexington, Mass., holds the patent on a prescription melatonin pill.5 The patent is not on an actual pill, but on the proper dosage for using melatonin to enhance sleep, and, as Wurtman reportedly said, it applies whether melatonin is sold by prescription or over-the-counter. Moreover, neuroscientist/monopolist Wurtman expressed the thought that the FDA should at least force the pill-makers to put "correct" recommended doses on labels (presumably for a patent royalty) and to spell out what problems the hormone has proven useful for (again, presumably for a patent royalty). Although Wurtman has not yet profited from his suggestions that the FDA interfere in the melatonin marketplace, he has stated publicly, according to Dr. William Regelson, that excessive use of melatonin could cause people to drive into telephone poles.

Several months after the approval of Redux, one publication reported that Wurtman's holdings had increased to nearly $26.8 million, making him hardly a disinterested altruist.6 Today, however, with the ban on Redux and fen-phen, Wurtman's fortune has turned south. And more than just zeroing out his net worth, Wurtman stands to be vilified - even "crucified" - for his work to help railroad the FDA's approval of what is now widely believed to be a very dangerous drug that may have already damaged the hearts, lungs, and brains of hundreds of thousands of unwary users. The liability mavens are smacking their lips at the prospect of a scandal that may make the silicon breast implant settlements (which nearly put Dow-Corning out of business) seem like a teenager's allowance. It couldn't happen to a nicer guy.


  1. Rosenberg R. FDA Panel to deal with antiobesity drug on Monday. Boston Globe. Saturday, September 30, 1995;61.
  2. Squires S (Washington Post). Redux offers hope in fighting obesity. The new drug can help control appetite. But yes, you still have to eat less and exercise more. Philadelphia Inquirer. Monday, June 10, 1996.
  3. Foreman J. Melatonin bandwagon gets crowded. Boston Globe. Monday, April 10, 1995;25.
  4. Marrero K. Style plus focus - smart drugs: Rx for brain power? The Washington Post. June 09, 1992;E05.
  5. Elias M. Melatonin maelstrom hyped hormone may be both blessing, curse. USA Today. Wednesday December 20, 1995;1D.
  6. Rosenberg R, McCabe K. Investing taking stock - lots of it - in local biotechs.Boston Globe Wednesday, May 1, 1996;46.
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