Miracle medical cure or modern 'snake oil'?

THE BALTIMORE SUN

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.

They binge on food and alcohol, constantly chasing the chemical rush they cannot get from simple pleasures. But they never get enough. So they eat more, drink more.

"Why does the insufficiency manifest itself one way in you and one way in me?" he asked. "I have no idea why. I'm sure it's shaped by a combination of environment and heredity."

Later, he took in the cocaine-addicted, the depressed and the anxious. In a January 1994 news release, Dr. Hitzig said he had achieved 100 percent success with 185 alcoholics and 51 cocaine addicts. Additionally, 309 patients said their depression had eased.

He was drawing considerable attention as a maverick doctor and entrepreneur. He applied for a U.S. patent that would would entitle him to royalties anytime the drug is prescribed for his new applications. And he was drawing a flood of patients -- many from outside Maryland -- who paid $1,000 each for a year of treatment.

He was ousted from GBMC's medical staff after he was alleged to have interfered with another doctor's patient. He said his real sin was to criticize the hospital administration publicly for spending lavishly. The hospital has refused to comment.

Practice devoted to fen/phen

Dr. Hitzig says his practice is now completely devoted to the use of fen/phen for assorted disorders. He also takes the drugs himself to lose weight -- he says he has shaved 55 pounds in a few years -- and to control moodiness and anger.

One of his recent patients is David Howe Jr., a 29-year-old mechanic with a wrestler's build who got hooked on cocaine at 16. Last October, he drove to Dr. Hitzig's office, took a psychological test and downed his first dose of orange and blue pills.

In less than an hour, during a group session with other new patients, Mr. Howe felt something new.

"I started turning my attention toward him [Dr. Hitzig], toward what was going on," Mr. Howe said. The comprehension was just unbelievable." The cravings disappeared, and he left thinking he had kicked the habit.

He was wrong. Several weeks later, he stopped taking the pills and visited his dealer. Incarcerated a fourth time for stealing from his family's roadside restaurant and garage, he turned again to fen/phen, which he was allowed to take in jail.

"I was happy in jail, believe it or not," he said. "I read every day. My brain went from not wanting to know anything to being a little kid and wanting to know everything." Now, he manages the family garage, lifts weights and this year has lost 40 pounds of excess weight.

Said Mr. Howe, "Dr. Hitzig saved my life."

Combating allergies

The doctor has also drawn patients like Julie May, a 19-year-old college student from Canada, who was so crippled by allergies she spent little time outside the house.

"At the end of 30 minutes, I could take off the mask I had been wearing to protect me from perfume without having an allergic reaction," she said. "Now, I'm eating things that would have sent me to the hospital before."

To some doctors, the drugs' growing popularity is downright scary. Dr. Harry Brandt, who runs the eating disorders program at Mercy Medical Center, said nobody knows whether serious side effects will emerge over years of use.

"We're talking about the brain, a pretty complicated organ," said Dr. Brandt, a psychiatrist. "It's going to take many years of research to say what's going to make sense.

"With Valium, people said, 'We finally have an anti-anxiety drug that isn't addictive.' Now we know it's highly addictive."

Dr. Hitzig has alienated some patients with what they consider his aggressive manner and tendency to divulge private details of their lives in group sessions.

A medical student from Michigan who saw him for depression said he felt nervous when the doctor started sliding pills toward him across a desktop. Within a half hour, the drugs kicked in. "I felt sick, really sick, nauseated, upset stomach, so tense that my back was in bad pain."

Dr. Hitzig says he teaches patients to control side effects by adjusting the dosage of "fen" or "phen."

A Baltimore woman said the drugs helped her lose weight but caused her to retain fluid and feel pains in her chest. She lowered her doses, but stopped seeing him.

"Call it instinct or intuition," she said. "Red flags started going up. He was treating diabetes, asthma, depression. These pills sounded like a snake oil. A cure for everything. That usually can't be."

Dr. Hitzig is acutely aware of the "snake oil" charge, but said his theories have a simple elegance. On a poster, he lists more than a dozen illnesses he is treating the same way. "They are one disease," he said matter-of-factly.

Sometimes, he calls it "neurotransmitter disease." Sometimes, half-joking, he calls it "Hitzig's disease."

Many experts don't know what to make of his claims that the drugs can conquer allergies and even reverse the wasting effects of acquired immune deficiency syndrome, but they say the testimonials of longtime addicts are hard to ignore. Still, they say they won't be convinced until the drugs are subjected to scientific tests that pit the drugs against placebos.

Such experiments would answer a key question: Do some patients feel better because they expect the treatment to work? Are they influenced by a doctor's enthusiasm?

"In studying the actions of any drug in a clinical population, the placebo effect is enormous," said Dr. Solomon H. Snyder, a world-famous neuroscientist at the Johns Hopkins School of Medical who is working to develop a cocaine block himself. "In treating depression, it's about 50 percent."

Dr. Hitzig said he tried to interest Hopkins scientists in starting a clinical trial but was met with icy indifference. At the National Institute on Drug Abuse, however, a curious scientist decided to take a firsthand look.

'I've . . . seen them get better'

Dr. Richard B. Rothman, chief of the clinical psychopharmacology section, spent several weeks in Dr. Hitzig's office. He interviewed patients and compiled independent case studies of their progress. Soon, he started prescribing the drugs in his private practice -- treating drug addiction, alcoholism, depression and attention deficit.

"I am fundamentally a scientist as well as a physician," he said. "I can't get away from the fact that I've treated patients myself and seen them get better.

"If some people have a problem with the messenger, I don't think that should doom the message."

Dr. Rothman sees patients in the Roland Park home of Karen Pearce-Howell, a therapist who said the drugs helped her lose weight and halt a lifelong depression.

"If someone had told me there was a new anti-depressant that worked, I would have said, 'Oh, right.' " said Ms. Pearce-Howell, who counsels Dr. Rothman's patients.

Dr. Rothman proposed the clinical trials, but said he will encourage scientists outside NIDA to conduct them if the agency decides not to.

The agency's director, Dr. Leshner, said he is concerned about studies showing that fenfluramine damaged nerve cells that produce serotonin -- the very chemical the drug is designed to elevate. The experiments, including one by Hopkins neurologist Dr. George Ricaurte, were done on rats, squirrels, monkeys and other animals that were subjected to doses much higher than those prescribed for humans.

"We're still left with the fact that fenfluramine has a long track record of being safe at the usual clinical doses," said Dr. Rothman. "The other thing you have to take into account is that for many people, the risks of addiction and obesity far outweigh the potential risks of the medication."

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