Redux, the diet drug hailed as a landmark discovery, has hit a stubborn plateau.
Sales took off after Redux first went on sale last May. By August, 398,000 prescriptions had been filled, according to IMS America Ltd., a research firm in Totowa, N.J. Since then, however, prescriptions have barely budged from that level.With expected sales this year of over $200 million, Redux still qualifies as a big success. But sales forecasts a year ago were significantly rosier, and the number of people now taking the drug represents only a tiny fraction of the 45 million obese Americans that Interneuron Pharmaceuticals Inc., Redux's patent holder, estimated as the potential market.
Bill Boni, spokesman for Interneuron, says it's "hard to say" why sales of the drug have plateaued. Redux is believed to make users feel full by increasing levels of the brain neurotransmitter serotonin. But the risks of side effects, which include a rare but fatal lung disorder called pulmonary hypertension, have discouraged some patients - and insurers.
The northeast division of Kaiser Foundation Health Plan HMO stopped paying for Redux as of Jan. 15 due to concerns about safety. "Like many other things that seem wonderful, there are catches," says associate medical director Jerry Salkowe. "We felt it just wasn't worth the risk."
Some patients who have tried the drug have discovered that despite hopes of a pharmaceutical wonder, Redux doesn't work so well without - guess what? - a diet regimen and exercise.
"In spite of the spin that's been put on it, Redux doesn't work all that well," says Jerry Mulder, a family doctor in Boise. "Basically, people don't lose as much weight as they hoped they were going to."
Jeanne Diehl, a 42-year-old teacher from West Roxbury, Mass., says she lost 15 of her 200-plus pounds after she started taking Redux in June, but she says the drug stopped working after a few weeks. She kept taking it for several more months, but her weight stayed the same. "My doctor kept saying `You have to exercise more.' But that's not my lifestyle," she says. "I put all my hopes in (Redux), and it didn't do much at all."
In fact, a number of doctors have started using phentermine - an appetite suppressant and stimulant that's been around since 1959 - to enhance Redux's efficacy. Phen-ter-mine has become popular in recent years along with another diet drug, fen-flur-a-mine, in a combination known as phen-fen.
Even Sheldon Levine, a New Jersey diet doctor who hailed Redux as "the most important weight-loss discovery of the century" in his book "The Redux Revolution," now uses phen-ter-mine with Redux to boost its effect. "To tell you the truth," he says, "Redux works OK alone, but it works better when you take it with phentermine." Unfortunately, the older drug can cause dizziness, insomnia and, in some people, is mildly addictive, according to Physicians' Desk Reference.
American Home Products Corp., which is marketing the drug for Interneuron, points out it has always said that Redux should be used with diet and exercise. The company says about 30 percent of the nation's insurers provide at least some coverage of Redux. Audrey Ashby, a spokeswoman for American Home's WyethAyerst Lab-or-a-tor-ies unit, says sales are "meeting expectations" at the company. The drug "doesn't work for everyone," she says, adding that American Home has "heard from many patients who are satisfied and who have lost weight." In a one-year clinical trial of Redux on 800 obese people in Europe, 35 percent of those taking the drug lost 10 percent or more of their body weight, compared with 17 percent of those taking a placebo.
Interneuron and American Home maintain that the benefits of the drug outweigh the risks; obesity can cause numerous medical problems.