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Sunday, June 1, 1997
MICHELLE NICOLOSI Linda Tomlinson was a big believer in magic bullets. Back
pain? Take a pill. Fatigue? Take another.
So when "fen-phen" came along, the 56-year-old leaped at the chance the
fantastically popular drugs might help shed the extra weight she carried
around all her life. "She loved it," said her daughter Melinda Finnegan.
"She had been chubby all her life. She loved it because she was losing
weight."
One day in November, she collapsed. Two days later, she died.
The county coroner's autopsy attributes the death to pneumonia due to
congestive heart failure and an enlarged heart.
Finnegan is sure the drugs are to blame.
"I believe in my heart of hearts this pill had everything to do with
her dying," Finnegan said. "There's no doubt in my mind." ORANGE COUNTY
DEATHS Federal Food and Drug Administration officials are studying the
possibility that phentermine may trigger heart attacks, and are trying to
determine whether people on the drug are having more heart problems than
would be expected.
Researchers are analyzing reports of health problems and of the seven
deaths reported to the agency nationwide in patients who were taking
fen-phen. Officials said they have not seen reports from Orange County.
"We would like to see this information submitted to us," said James
Bilstad, director in the FDA's office of Drug Evaluation II.
The federal reporting system is voluntary, so many deaths and
complications from drugs go unreported.
In April, Los Alamitos obesity specialist Dr. Michael Myers spent three
hours filling out the FDA forms required to report nine cases of adverse
events in patients taking fen-phen, which included memory loss,
depression, a panic attack, a confusion episode that caused a car
accident, shortness of breath, insomnia, headache and anxiety.
"This stuff is a disaster," said Myers, a vocal diet-drug opponent who
has been quoted in the Wall Street Journal, Time magazine and on CBS' "48
Hours."
"The medical community thinks these are totally innocuous medications;
the patients think the same thing. I think this really is nasty stuff.
It's definitely going to kill some people. It's going to cause disability
in people. It's totally unbelievable to me anyone would take such risks."
But few doctors take the time to file reports, federal officials said.
The voluntary reporting system and the commonness of heart problems
make it hard to know whether the drug is triggering heart attacks, Bilstad
said.
Another problem: Medical examiners have found no way to tell whether
fen-phen contributed to or caused a death, said John Eisele, deputy
medical examiner with the San Diego County Medical Examiner.
"To my knowledge, you can't differentiate anatomically," he said.
Dr. James L. Frost, president of the National Association of Medical
Examiners, agreed there's no way to tell if heart failures were caused by
patients' existing disease or by the drugs.
"I don't think we can answer these questions yet," said Frost, deputy
chief medical examiner for West Virginia. "We need to take a look at it."
A close look at Orange County's seven deaths could shed some light,
said diet drug expert Dr. George Blackburn, director of the center for the
study of nutrition in medicine at Beth Israel Deaconess Medical Center and
Harvard Medical School in Boston.
"We're certainly willing" to work with interested agencies, said Jim
Beisner, chief deputy coroner in Orange County.
RISKS AND BENEFITS Still, an estimated 18 million Americans have taken the drugs together,
despite the fact that there are few long-term studies showing whether they
are safe when taken together.
The FDA approves drugs, but does not govern the practice of medicine _
how the drugs are used once they are approved.
"Information on the safety and efficacy of drug combinations in the
treatment of obesity is extremely limited," says a 1996 article in the
Journal of the American Medical Association.
The article, written by a federally sponsored panel of experts,
concluded too little is known about the long-term risks and benefits of
the drugs to merit using them routinely, "though it may be helpful in
carefully selected patients."
It's up to doctors and patients to use the drugs only in those most at
risk of a serious health threat from their obesity, Blackburn said.
Yet, millions use the drugs, including many who are seeking cosmetic
weight loss of just a few pounds.
Vicki Thomas developed primary pulmonary hypertension _ a sometimes
fatal lung disease associated with diet drugs _ a few months after taking
fen-phen. The risk of developing PPH is 1 to 2 per million in the general
population; it's as much as 46 per million in those who have taken diet
drugs three months or longer.
Thomas answered one of the dozens of newspaper ads touting the wonders
of fen-phen and got the weight-loss drugs at a nearby Los Alamitos clinic,
hoping to lose just 10 or 15 pounds.
"I wanted to get back into the clothes I used to wear," Thomas said. "I
didn't like being heavier."
She says she had no idea the drugs were meant just for the very obese,
or that they put her at higher risk for the lung disease that left her
attached to an oxygen tank for months and may prove fatal.
"They didn't say anything," she said.
Another worry: Lab studies show that animals given higher doses of the
drugs than those taken by humans develop brain damage, said Dr. George
Ricuarte, assistant professor of neurology at Johns Hopkins Medical
Center.
"That's a major concern for members of the scientific community,"
Ricuarte said. Similar studies have not been done in humans, he said.
"Further studies evaluating the possibility of subtle
neuropsychological changes ... are warranted," authors of the JAMA article
wrote.
Blackburn and many obesity experts agree that in some patients with
life-threatening conditions that can improve with weight loss, the
potential benefits of the drugs may outweigh the risks.
Dr. Bruce Brundage, chief of cardiology at Harbor UCLA Medical Center,
disagrees.
"The physicians I work with are very concerned," said Brundage, who has
treated Thomas and a handful of other PPH patients who had taken fen-phen.
"I don't believe in any appetite suppressant of any kind because of
these concerns. Anybody with common sense would be very concerned about
taking this drug. If you get PPH, it may be fatal. If I told you a drug
rarely caused leukemia, would you take it?"
Myers, who has a Web site warning patients about the dangers of the
drugs, recalls an ad he saw recently asking, `What have you got to lose
but the weight?'
"What have you got to lose?" he asks. "It's called your life."
SIDEBAR FDA experts said phentermine may trigger life-threatening
problems such as heart attacks, and are tracking reports of deaths as well
as survived heart attacks and other possible complications, officials
said.
The drug can cause blood vessels to constrict, increase the pulse rate
and provoke an irregular heartbeat _ all things that might trigger a
cardiovascular event, officials said. "We're certainly looking at that as
a possibility," said Dr. Leo Lutwak, medical officer in the FDA's division
of metabolism and endocrinology.
"For us to take action, we would have to have a fairly strong level of
suspicion," he said.
But FDA's systems make it "very difficult" to tell whether people on
the drug are more likely to have heart problems, said Dr. James Bilstad,
director of one of the FDA's offices of drug evaluation.
The system relies on voluntary reports of complications filed by
doctors. Most don't report, so FDA researchers are left studying a small
percentage of the phentermine puzzle, hoping to tell from the pieces
they've got what the big picture might be.
"To be able to detect an increase from the voluntary reporting system
is a challenge," Bilstad said. "It's not a sensitive way of doing it."
THE `FEN-PHEN' PHENOMENON 1959: |