METHADONE PATIENTS AND AIDS DRUGS

Addicts Avoid AIDS Drugs, Fearing They Affect Methadone

NEW YORK -- Many drug addicts infected with HIV are missing the
benefits of powerful new AIDS drugs because of widespread suspicion on
the street that the drugs reduce the calming effect of methadone,
medical experts and advocates for AIDS patients say.

Nationwide, intravenous-drug use has directly or indirectly accounted
for 36 percent of the AIDS cases since the epidemic began nearly two
decades ago. The greatest problem is among minority groups, with 38
percent of all AIDS cases related to drug injection among blacks and
37 percent among Hispanic people, compared with 22 percent of all
cases among whites. The numbers for women are also striking. Since
1981, at least 61 percent of all AIDS cases among women have been
attributed to intravenous-drug use or sex with partners who inject
drugs, compared with 31 percent of cases among men, according to the
Federal Centers for Disease Control and Prevention in Atlanta.

There is no concrete scientific evidence that the AIDS drugs, known as
protease inhibitors, interfere with methadone. But the perception that
they do adds yet another obstacle to treatment for a group that is
difficult to track and has historically been underrepresented in
clinical trials to test new drugs.

Among doctors, researchers, patient advocates and even some drug
users, there is much dispute over how much protease inhibitors affect
methadone. Some treatment specialists suggest that addicts' multiple
health problems play a more dominant role than the interaction of the
drugs. But few deny that many people on methadone believe otherwise.

Howard Josepher, executive director of Exponents, a nonprofit group in
Manhattan that provides counseling and support for drug users who have
AIDS, said suspicion of AIDS drugs was widespread on the street.

"We hear a good deal of trepidation and discomfort that some methadone
patients are experiencing," he said. "These are things we just don't
know much about. But we find a lot of people are really skeptical
about the medications."

In New York City, half of the estimated 200,000 intravenous-drug users
are HIV positive. Roughly 10 percent to 15 percent of the city's drug
users are enrolled in the 34,000 methadone treatment slots in the
city. There are 40,000 slots statewide.

Statistics vary on the number of drug users taking protease
inhibitors. Some estimates put the number at one-quarter to one-third
of all intravenous-drug users in the city. The number of addicts who
shun protease inhibitors altogether, or avoid them for brief periods,
is equally difficult to determine.

"The reality is that it's a hard group to pull together," said Dr.
Diana Williamson, the medical director of Harlem United, a nonprofit
advocacy group for people with AIDS, and also a clinical research
fellow at Mount Sinai Medical Center in Manhattan.

"Fears are generated and perpetuated by word-of-mouth and on the
street corners. Some are true. Some are not true. Some get validated.
Some don't. It doesn't matter. It's a world unto itself and they don't
get respected the way they should."

James Turner, 40, an addict with HIV, takes a dose of methadone each
morning to ease his heroin cravings. He also has a complex
pill-popping schedule that includes protease inhibitors. But he is
convinced that the protease inhibitors "eat up the methadone," as he
puts it. He said he had endured many sleepless nights in his cluttered
room, the size of a prison cell, in a Bronx hotel, because the
methadone wore off too quickly.

To reverse the effect, Turner said, he stopped taking the AIDS drugs

for three months this year. During that time, he said, he continued
taking methadone but was never sick. But when he decided to resume the
AIDS drugs in May because the amount of HIV in his blood shot up, he
felt sick again.

Addicts who inject drugs have made up the greatest number of AIDS
cases in New York City since 1988, outpacing gay men every year,
sometimes at more than double the number, according to the State
Health Department. Drug users account for 44.6 percent of all AIDS
cases in the state, but their circle of infection spreads much
further. They are linked to most heterosexual cases and virtually all
pediatric AIDS cases, state health officials said.

AIDS cases among drug users are more concentrated in Northeastern
states, including New York, New Jersey and Connecticut, than on the
West Coast. In California, about 20 percent of the cases are related
to intravenous-drug use, while nearly 60 percent of AIDS patients are
gay men, according to California health officials.

Turner, the addict who has had trouble with his AIDS drug regimen,
said he had persuaded a Park Avenue psychiatrist to prescribe him the
tranquilizer Xanax to calm his body when the methadone wears off
around 8 each night. But other drug users, like Balil Haneef of
Manhattan, have not found such a creative way to compensate for their
needs.

Haneef, 40, a peer drug counselor who tested positive for HIV 14 years
ago, said he quit both the AIDS drugs and methadone therapy two months
ago. He said the combination of drugs made him unbearably sick.

The other day, Haneef was preparing to lead a support group meeting in
a dingy patient lounge on the medical detoxification floor at St.
Clare's Hospital and Health Center in midtown Manhattan. But he seemed
a bit slow and hesitant in his speech. His doctor said he shows signs
of dementia related to advanced AIDS.

Haneef, who works for a nonprofit agency that helps drug users, leads
the support group meetings twice a day. With his experiences -- he
overdosed four times and has an extensive prison record -- Haneef said
drug addicts can relate to him and he is comfortable around them.

In an interview, he said he uses "medical ebonics" -- his own street
patois -- to break down all the intimidating medical AIDS jargon. "I
don't have it prewritten," he said. "It comes natural."

He described the combination of protease inhibitors and methadone as a
bad mix, like milk and lemon juice.

"I was feeling really bad," Haneef said. "I just felt like I wasn't
getting the full effect" of the methadone.

Haneef, who said he has not used illegal drugs in seven years, knows
of other drug users who seem to be doing well on protease inhibitors.
He concedes that he took the AIDS drugs on and off for 18 months
before stopping cold two months ago.

At his doctor's urging, he has agreed to start fresh on protease
inhibitors soon because he is worried about his deteriorating health.
However, Haneef plans to stay off methadone. He said the rigidly
structured program was too controlling.

Yet the methadone programs, which involve daily trips to a clinic, are
an efficient way to monitor the health of infected people -- and to
prevent them from spreading the virus on the streets, many treatment
specialists say. Research shows that the longer drug users are in
methadone programs, the less likely they are to contract HIV.

If the epidemic is ever to be stemmed, experts say, it is critical to
collect more precise scientific information on the interaction between
protease inhibitors and other drugs, including methadone, heroin and
other street drugs.

"Until we have the answers, it's going to be difficult to convince
people to take the medications because of the anxiety," said Dr. John
Jacobs, medical director of the clinical AIDS care programs at New
York Hospital. "Anxiety is an obstacle for this population to get what
may be life-sustaining therapy."

Doctors have found that the rumor mill among drug users is

extraordinarily extensive and detailed in the methadone clinics run by
the Albert Einstein College of Medicine in the Bronx. When clinics
there introduced a new form of methadone that lasts as long as three
days instead of 24 hours, patients were immediately suspicious.

"It's a population that wants things the way they are; they don't want
to be experimented with," said Dr. Peter Tenore, associate medical
director in the college's division of substance abuse. "When something
new comes around, they are reluctant to try it."

One-third of the 4,000 methadone patients in the 10 clinics are HIV
positive and the majority take protease inhibitors of different types.
Tenore said clinical observations have revealed no major problems in
taking the combination of drugs, though no specific studies have been
conducted to test patients' blood before and after being treated with
the AIDS drugs.

Last year, a drug interaction study was conducted by Abbott
Laboratories in Illinois, which manufactures a protease inhibitor
called ritonavir. The study found that methadone levels were reduced
by ritonavir, which could lead to withdrawal symptoms, the opposite of
what the study's investigators had predicted. But many scientists say
the monthlong study has serious flaws because it used healthy,
noninfected volunteers who took very low doses of methadone.

Several other studies are now in the pipeline, including a federally
sponsored study that will use HIV-positive patients already on
methadone. It is expected to begin later this summer and should be
completed in about a year.

"This study will clarify whether we need to worry about this or not at
all," said Dr. John Gerber, the study's principal investigator and a
professor at the University of Colorado Health Sciences Center in Denver.

Following the exacting regimen of drug cocktails that include protease
inhibitors can tax even the most stable of patients. The cost of the
drugs is not a issue in New York, unlike some states, because poor
people can get them through Medicaid or a state drug assistance program.

The cocktails generally combine a protease inhibitor with older
antiviral drugs like AZT. The protease inhibitor blocks a key viral
enzyme called protease, and the older drugs block a different enzyme.
The multiple-drug assault suppresses the virus.

When protease inhibitors were first being tested, the trials were
dominated by gay white men who clamored for new treatment therapies.
Addicts tended to be ignored.

But that is slowly changing. The federal government has become more
aggressive in enrolling addicts as well as women and members of
minorities in the trials that it sponsors. And some pharmaceutical
companies are looking more attentively at addicts as important
consumers of their new drugs.

Some medical experts and advocates for AIDS patients worry that a
perception that drug addicts have difficulties with protease
inhibitors will feed into the popular stereotype that addicts are
notoriously bad at adhering to a strict medical regimen.

But at Harlem Hospital Center, Dr. Wafaa El-Sadr said clinical trials
of many new drugs there have included a substantial population of
intravenous-drug users for 10 years and produced "excellent data and
follow-up."

"It tells you that the whole notion of people thinking that this
population is not reliable is wrong. It's a generalization," she said.

Subtle prejudices show up in what AIDS advocates demand from drug
companies, said James Learned, deputy director of People with AIDS
Health Group, which focuses on treatment education and counseling in
New York. "There is a hierarchy, and certainly people who are using or
even in recovery have been at the bottom of the barrel," he said.

In his list of requests to drug companies, Learned said he has never
placed the study of interactions among protease inhibitors and
methadone or illegal drugs at the top.

"It has ended up somewhere but never at the top," he said. "Maybe we
should do it, since there is a real concern out there."

Copyright 1998 The New York Times

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David Mickenberg The Lindesmith Center (212) 548-0383
dmickenberg@sorosny.org

Checked-by: "Rich O'Grady"