In an interview with Psychiatric Times, however, Atkinson, a professor of medicine and nutritional science and director of the medical school's clinical nutrition program, denied that his study justified giving the phentermine(Drug information on phentermine)/Prozac combination on a mass basis. "I feel uncomfortable in the position of senior author on this [abstract] if it is used as a justification for much of anything," he said. "[This] is clearly an anecdotal abstract, and I think it would be hazardous to draw any great conclusions about the safety or effectiveness from that. And this is, to my knowledge, the only thing in the literature that has used phentermine and Prozac."
Atkinson balked when told Nutri/System described his study as one "conducted at a major university medical school" that "determined that a combination of two medications made participants feel more full and less hungry."
"It's pretty scary, to say that," Atkinson said. Although the investigation was done with careful follow-up, he added, "what's in that abstract was not designed as a formal scientific protocol. It was a collection of cases and a comparison...I do feel uncomfortable with my abstract-not even a paper, an abstract-being cited as evidence for the safety and efficacy of this combination."
Calling some of Nutri/System's ad claims a "lot of hype," Atkinson lamented the commercialization of the treatment of obesity. "I'm sorry that medicine and physicians for so many years neglected obese people [to the extent] that obese people feel they have to go to a shopping mall to get their really severe disease treated," he said. "This is America. If there is a demand, whether it's for marijuana, or crack cocaine, or obesity treatment, people will seek it, and people will supply it. And that's what's going on here. I don't approve of using the tiny little abstract that I had, which was not even a formal study. I think they [Nutri/System] are vastly overblowing the data."
Anchors' claims for the phentermine/Prozac combination are the subject of his just-released book called Safer than PhenFen. A description of his clinical experience with more than 500 patients who were prescribed the Prozac combination over the past two years, Anchors' book concludes that "obesity is a biochemical problem in the brain and it can only have a chemical answer." In a letter published in the June 9 issue of Archives of Internal Medicine, Anchors concluded that "fluoxetine and some other selective serotonin reuptake inhibitors are just as effective and probably safer than fenfluramine in the combination with phentermine in the medical treatment of exogenous obesity. They should be used exclusively, instead of fenfluramine, until the results of large randomized, double-blind trials of both drugs become available."
It is this reliance on preliminary, largely anecdotal reports, lacking the scientific rigor of long-term, double-blind, placebo-controlled research, that has some experts seething at the mass marketing of the phentermine/Prozac combination. Even DiBartolomeo concedes that there is no long-term data. "What I anticipate happening is that now that there is some data on phen-Pro short term, that it's very effective and without side effects...we'll find that more researchers will begin to test this on a longer-term basis. But we do not have very long-term data at this point," he said, although he denies that using the drugs now is an inappropriate off-label treatment regimen.
But Paul Hamburg, M.D., an assistant professor of psychiatry at Harvard Medical School, and associate director of the eating disorders program at Massachusetts General Hospital in Boston, disagrees. "The thought that anyone's response to this surprise [the discovery of valvular heart disease]-which is going to result in death and a tremendous amount of morbidity, especially for obese patients who can least afford to have open heart surgery-should be to plunge ahead and try another untested combination of drugs, even for the medically obese... is the height of foolishness."
Peter D. Kramer, M.D., a Providence, R.I., psychiatrist and Psychiatric Times columnist whose best-selling book Listening to Prozac helped turn the antidepressant into a household name, agrees. "This is one of many approaches you'd rather have studied than just done for large numbers of people," he said. "When you see that there's a side effect that can occur in a large percentage of people-there were up to 30% of the people on phen-fen [who] had suffered some change in the heart valve-you really know that there can be less frequent side effects that only emerge from systematic study. So it does seem difficult to recommend this. It does seem worrisome. These are powerful medicines."