Decades after their quiet entry as appetite suppressants, two drugs that adjust the brain's natural chemistry are attracting hundreds of patients who are lured by testimonials that daily doses can halt addictions and a multitide of ills.
The drugs' chief proponent, Dr. Pietr Hitzig of Timonium, claims overwhelming success with more than 1,800 patients suffering from conditions as diverse as cocaine addiction, alcoholism, Tourette's syndrome, bulimia, chronic fatigue, chemical sensitivity, hay fever, hives, phobias and obesity.
With two public relations agencies touting his treatments and Dr. Hitzig spreading the word on the Internet, the Ivy League-educated doctor has attracted a nationwide clientele -- and critics who say the drugs are being prescribed indiscriminately and, perhaps, dangerously.
Nothing has drawn more interest than reports that the drug combination can help people kick cocaine and alcohol. Now, those claims are being weighed by the National Institute on Drug Abuse (NIDA), which is considering a proposal to begin tests that would determine whether the therapy is a safe and potent weapon against the scourges.
"The biggest need in the war against drug abuse and addiction is a cocaine medication," said Dr. Alan I. Leshner, NIDA's director. "If we can find a cocaine medication, I don't care where we get it from as long as it is scientifically defensible and medically valid."
"This is a toughie," he said.
The drugs -- fenfluramine and phentermine, called "fen/phen" for short -- work by regulating the brain's supply of two important neurotransmitters -- chemicals that relay messages from one nerve cell to the next and account for the way people feel and act.
Developed in the 1950s, phentermine curbs appetite by stimulating the brain to release more dopamine -- a neurotransmitter associated with pleasure and the relief of pain. Fenfluramine, marketed a decade later, elevates serotonin, a neurotransmitter that regulates desires and helps people feel content.
Although they received government approval as prescription diet pills, the drugs were not wildly popular in the United States.
People complained of side effects. "Phen" made some people jittery and sleepless. "Fen" made people nauseated and sleepy. The drugs were also tainted by evidence that amphetamines -- "pep pills" widely prescribed as diet pills in the 1960s -- caused addiction and psychosis.
Fenfluramine and phentermine are chemically similar to amphetamines. But many doctors insist they are not addictive, possibly because they are milder and do not create an outright "high."
The drugs' fortunes began to change about a decade ago when Dr. Michael Weintraub, a pharmacologist then at the University of Rochester, was preparing lectures while snowed in at the Kansas City airport.
Dr. Weintraub wondered what would happen if the drugs were taken at lower dosages and in a "yin-yang" combination. He thought the side effects might cancel each other out because they were virtual opposites -- like drowsiness and nervousness.
With side effects minimized, the drugs might be taken in maintenance doses for years or perhaps a lifetime. This would put obesity on a par with high blood pressure and other chronic diseases -- ailments that can be kept at bay with proper medication.
His subsequent study, published in 1992, seemed to support his thesis. Patients placed on exercise, diet and the two drugs lost an average of 34 pounds over an eight-month period -- three times as much as those who exercised and trimmed calories but took a placebo.
Just as important, patients didn't develop side effects worse than dry mouth. Nor did they become addicted, although many regained weight once they went off the drugs.
The study, published in a major medical journal, rescued the drugs from obscurity. Diet centers across the country, including a few in Maryland, began to structure their weight-loss plans around fen/phen. So did many physicians.
A mental firestorm
One was Dr. Paul M. Rivas, a Lutherville internist who said he tries to achieve modest weight loss with extremely low doses. "In a sense, it has cured you, but only as long as you're on the pills," he said. "It's like controlling a chronic illness."
For Dr. Hitzig, a general internist who worked at the Greater Baltimore Medical Center, the article by Dr. Weintraub lighted a mental firestorm. He searched his computer files for female patients weighing more than 170 pounds, and invited more than 50 to try the new therapy.
"I assume that people come to me with the idea that I'm their expert," he said. "When I find out something that will help them, I'll get in touch." Practically all who tried the drugs began to lose weight, he said.
One day, Dr. Hitzig was trolling the Internet for information on addictions when it occurred to him that the overeater and the alcoholic suffer from the same disease -- low supplies of the neurotransmitters that make people feel satisfied.