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Volume 4, Number 32
June 26, 2003
In this edition:
UN AIDS Report Estimates
Condom HIV Failure Rate at 10 Percent
A draft report for the United Nation’s AIDS agency
has found that even when people use condoms consistently,
the failure rate for protection against HIV is an estimated
10 percent, making them a larger risk than portrayed by many
advocate groups.
The report, which looked at two decades of scientific literature
on condoms, is likely to add fuel to a heated political battle
on U.S. policy in fighting AIDS in the developing world.
The debate pits proponents of abstinence, who say that the
Bush administration should abandon or sharply reduce condom
promotion, against health specialists, who say that condoms
play an integral part in preventing the spread of AIDS. The
disease has killed more than 20 million people worldwide
and now infects 42 million.
In previous reports, condom effectiveness against HIV has
been widely estimated at between 46 percent and 100 percent.
Many advocates of condoms have said they provide nearly 100
percent protection when used correctly. UNAIDS has voiced
hope that the report, which was viewed by the Boston Globe,
not only clears up confusion over condom effectiveness but
also helps educate people in the United States and worldwide
about how to use condoms properly.
The conclusions do not mean that every tenth condom is defective,
but rather that something has gone wrong in about 10 percent
of their use. In many cases, specialists said, human error
is the source of the failure, resulting in condoms slipping
off, breaking, or not being put on early enough.
The report is under review by UNAIDS, and a final version
will not be released until the end of the month. The organization's
top science adviser said the 10 percent failure estimate
was “reasonable.”
The leading author on the report, Norman Hearst, a professor
at the University of California at San Francisco, “makes
a cogent argument that we should be talking about safer sex,
not safe sex, with condoms,” said Catherine A. Hankins,
a chief scientific adviser to UNAIDS.
The report also said that the failure rate to protect against
HIV was probably the same in preventing pregnancies.
Edward C. Green, a senior research scientist at the Harvard
School of Public Health, said that the data on condom effectiveness
should help set policy and that people in developing countries
should know about that risk. One chance in 10 of condom failure
is “not good enough for a fatal disease,” Green
said. “The way condoms are marketed in Africa and other
developing parts of the world is as if they were 100 percent
safe. Condoms have brand names like Shield and Protector
that gives the impression that they are 100 percent safe.”
Shepherd Smith, president of the Institute for Youth Development,
a group that advocates abstinence, also said the draft report
and other reports should lead to an evaluation of HIV-prevention
efforts. “We took an idea that was unproven in the
'80s, said this was what's going to work in this epidemic,
and clearly it hasn't,” he said. “The data doesn't
support it.”
Condom promoters have long said that condoms can provide
almost complete protection against HIV. For instance, a September
2002 report, “Condoms Count,” published by Population
Action International, a Washington-based policy advocacy
group, said, “Public health experts around the globe
agree that condoms block contact with bodily fluids that
can carry the HIV virus and have nearly 100 percent effectiveness
when used correctly and consistently.”
One of its cited sources was a 2001 National Institutes
of Health report. The report, which involved four government
agencies, 28 condom specialists, and a review of 138 scientific
papers, found that “consistent condom use decreased
the risk of HIV/AIDS transmission by approximately 85 percent.”
The National Institutes of Health and draft UNAIDS reports
cited inherent difficulties in coming to such an estimate.
Health analysts said the only way to arrive at such a figure
is to examine a combination of data: interviews with sexually
active heterosexual couples; self-reported data on condom
use; and long-term HIV testing of uninfected people. Nada
Chaya, a senior research associate at Population Action International
and the lead author of “Condoms Count,” said
of the “nearly 100 percent effectiveness” claim, “technically
we are right, if condoms are used correctly and consistently.”
She said her group and others “should carry more responsibility” in
telling people that condoms do not completely protect against
HIV. “There is no safe sex,” she said. “Safer
sex? Yes.”
Terri Bartlett, the group's vice president for public policy,
expressed concern that proponents of abstinence alone would
use the 10 percent failure estimate to reduce condom availability.
This, she said, would lead to more people becoming infected
with the deadly virus. The review over condom effectiveness
closely follows Congress's passage of President Bush's $15
billion plan to fight AIDS during the next five years. The
president repeatedly has said that nations should follow
the example of Uganda, which engineered a dramatic reversal
of HIV infection rates in the 1990s through strong political
leadership and the ABC program, which stands for abstinence,
being faithful to one partner, and, if that fails, use of
condoms.
Abstinence advocates, which include many faith-based groups,
seized on the Uganda example, cited relatively low condom
use there, and won a provision in the legislation that said
one-third of the AIDS prevention money must be used in abstinence
programs by the third year of the five-year plan.
Green, the Harvard research scientist, and many public health
specialists said that a comprehensive approach must be used
to fight AIDS and that the most important part of the ABC
approach probably is B -- being faithful to one partner.
“If we tell youth that if you use condoms, you will
be safe, then we are actually fueling the epidemic,” said
Vinand M. Nantulya, senior health adviser at the Global Fund
to Fight AIDS, Tuberculosis, and Malaria. Nantulya, formerly
a key adviser to President Yoweri Museveni of Uganda, said
the key lesson from Uganda was “that it wasn't a choice
between abstinence or condoms, but that it was everything.
In Uganda, we promoted condoms in the context of if you stray,
use a condom.”
Hankins, the UNAIDS adviser, also argued for a combination
of approaches to fight AIDS and said that each country, and
areas inside countries, require tailored responses to the
epidemic. She said condoms had a role everywhere. The key
now, she said, was to teach correct ways to use them.
The most frequent errors: men don't leave enough space at
the end of the condom to collect the sperm; not using lubrication,
which reduces the risk of the condom breaking; and not putting
on a condom prior to genital contact.
“We need a combination of prevention, postponing
sexual activities, reducing partners, and using condoms,” Hankins
said.
[Boston Globe on 6/22/03]
HIV Increasing Among Adolescents and Young Adults in Massachusetts
The incidence of HIV and AIDS among teens and young adults
in Massachusetts has risen significantly over the past four
years, accounting for 301 of the new cases reported during
that span, according to new statistics from the state Department
of Public Health.
Since the state started its HIV surveillance in 1999, the
number of reported cases among 13- to 24-year-olds has risen
from 6.1 percent to 8.7 percent. The statistics show that
77 percent of the cases were diagnosed in 19- to 24-year-olds,
although infection can happen much earlier than diagnosis.
Intravenous drug use was the cause of 10 percent of the
new cases among adolescents and young adults.
“These new statistics are alarming,” Public
Health Commissioner Christine Ferguson said in a statement.
Cities with the highest percentage of HIV and AIDS diagnoses
within younger age groups were Chelsea, Medford, Lawrence,
Chicopee, Brookline, Somerville, Holyoke, Everett, Brockton
and Revere.
Over the past four years, the number of new HIV and AIDS
cases among those over 50 has also increased, accounting
for 12 percent of the reported cases in 2002, compared to
9.2 percent in 1999.
According to the most recent report from the Pediatric Spectrum
of Disease Study, no infants in Massachusetts contracted
HIV from their mothers during 2001-- the first time that
has been achieved since the project began monitoring perinatal
transmissions.
Since 1999, a total of 4,219 HIV and AIDS cases have been
reported in Massachusetts. Since the onset of the disease
in the mid-1980s, 17,998 residents have been diagnosed with
AIDS. Sixty percent have died. There are currently about
19,000 to 21,000 living with HIV/AIDS. According to public
health officials, about one-quarter of them do not know their
HIV status.
[Associated Press, 6/24/03]
Study Finds High HIV Incidence and Risk Taking By Gay Men
in South Beach; More Effective Interventions Needed
Recent studies have reported high rates of sexual risk-taking
and HIV infection among young men who have sex with men (MSM).
In 1996, Miami-Dade County, Florida, had one of the highest
AIDS rates among U.S. metropolitan areas. South Beach, situated
at the southern end of Miami Beach, was among the top three
ZIP-code areas for Miami-Dade County in the number of reported
AIDS cases.
A new study published in the Journal of Acquired Immune
Deficiency Syndromes has found that a high prevalence of “unprotected” sex,
drub abuse and HIV infection among MSM in South Beach.
All 100 men who completed the study interview and questionnaire
provided a specimen for OraSure HIV testing, and 93 percent
reported a prior HIV test. Fifteen percent tested positive
for HIV antibodies. The researchers estimated the incidence
South Beach’s HIV incidence to be 6.3 percent.
Recent migrants to South Beach were more likely to test
HIV positive than were longer-term residents. There was a
trend for MSM who did not have a primary partner to be more
likely to test HIV positive. Orasure test positivity was
associated with higher reported number of anal intercourse
partners and "cruising" in public areas for sex
partners in the prior year. Neither age nor race/ethnicity
was associated with HIV antibody status.
Of those surveyed in this study, approximately one half
reported using ecstasy (MDMA; 51 percent), or cocaine (48
percent) within the previous year. Forty-five percent had
used three or more “recreational” drugs within
the past year; 34 percent reported at least weekly use of
some drug. More than half (56 percent) reported having had
anal sex while high on alcohol and/or drugs during the previous
year; 24 percent reported that at least one half of their
anal sex was under the influence of alcohol and/or drugs.
Within the past year, 81 percent of respondents reported
anal intercourse; 45 percent of the sample reported engaging
in “unprotected” anal intercourse (UAI). UAI
was not associated with age, race, educational background
or length of residency. MSM having a primary partner were
significantly more likely to report engaging in UAI in the
last year than were MSM not having a primary partner. Men "cruising" in
public places were significantly less likely to report UAI
than were those who did not report "cruising."
MSM who reported engaging in “unprotected” receptive
oral intercourse with ejaculation tended to report engaging
in UAI. Having a primary partner, "cruising," and
fellatio with ejaculation were significant predictors of
UAI in the past year in the logistic regression model.
"The high prevalence of UAI and HIV infection in South
Beach attest to a previously undocumented public health concern," the
study authors concluded. "The extremely high estimated
incidence for young MSM in South Beach highlights the urgent
need for more effective risk-reduction interventions and
further epidemiological research on resort areas."
Of the 100 MSM interviewed, 48 identified as white, 44 as "Hispanic,
Latino, Spanish heritage" five as African American,
and three as "other." Median age was 28 years.
Forty-one (41 percent) reported a current relationship with
a primary partner. By self-identification, 84 percent identified
as gay or homosexual; 12 percent as bisexual; and 4 percent
as heterosexual.
[Journal of Acquired Immune Deficiency Syndromes, 6/1/03]
Enjoyment of “Unprotected” Sex, Drug Abuse and
Poor Communication All Triggers for Risky Sex Among Gay Men
Two behaviors that proved the most likely predictors of
risky sexual behavior among gay men— drug abuse and
enjoyment of “unprotected” receptive anal sex--
accounted for risky sex in one-third of the men in a recent
study, according to Margaret A. Chesney, PhD, who conducted
the study while at the University of California, San Francisco.
Gay men who have poor communication skills and feel unable
to protect themselves against HIV are more likely to engage
in risky sexual behaviors, according to the newly released
data.
The research, published in the June 2003 issue of the American
Journal of Public Health, concludes that these are among
many different combinations of behavioral factors that may
be linked to risky sex among gay men.
The data reported by Chesney and colleagues come from a
study, still in progress, called EXPLORE, the first randomized
clinical trial examining whether behavioral counseling might
help reduce the rates of HIV infection in the United States.
The men enrolled in the study are at "high risk" of
HIV infection, according to Beryl Koblin, PhD, of the New
York Blood Center and colleagues. Koblin and colleagues reported
that alcohol and drug use, multiple partners or one primary
partner are all associated with “unprotected” sex
among the men
The results of the trial will be available in 2004. The
study was supported by the National Institute of Allergy
and Infectious Diseases, the National Institute of Mental
Health and the National Institute on Alcohol Abuse and Alcoholism.
[Medical Letter on the CDC & FDA, 6/22/03]
Oklahoma Man Sentenced to Prison for Exposing Others to HIV
An HIV-infected man who police said sought out mentally
retarded individuals to satisfy his sexual appetite received
prison time Wednesday for sexually assaulting two men. Luis
Jimenez showed no emotion as Garfield County District Judge
Ronald Franklin pronounced sentence of 10 years for first-degree
rape and forcible oral sodomy and five years for exposing
others to the AIDS virus.
Besides his prison terms, which will run concurrently, Jimenez
will pay nearly $2,500 in medical costs incurred since he
was arrested in December.
Jimenez was suspended from his position as a physical therapy
technician at St. Mary's Regional Medical Center after his
arrest. Hospital officials said they had no knowledge of
his alleged activities or health status.
Jimenez's job at the hospital allowed him access to one
of his victims, according to court documents. He went to
a man's house November 16 under the guise of checking up
on the patient's stomach ailment, according to an affidavit
filed in Garfield County District Court. Jimenez told the
man, who relies on his sister to care for him, he needed
to come to his house for a more thorough checkup, the affidavit
states. Jimenez then forced the man to have sex with him.
He admitted to having sex with the man when interviewed November
20 by Enid police, according to the affidavit. He also was
accused of forcibly sodomizing another man in October 2000
after the man had raked some leaves at his house.
[Associated Press, 6/25/03]
Rapid HIV Test is Centerpiece of New Prevention Effort
A new, rapid HIV test is the centerpiece of a major effort,
starting Friday, to bring people who don't know they're infected
with the AIDS virus out of the shadows and into a doctor's
care.
The Centers for Disease Control and Prevention plans to
buy nearly 250,000 rapid tests for $2 million and distribute
them to state health departments as part of a major HIV-prevention
initiative, according to the test's manufacturer. The announcement
is one of a flurry of activities planned by AIDS advocacy
groups, AIDS service providers and their corporate partners
to underscore the importance of testing on Friday, National
HIV Testing Day.
"It's tragic that more than two decades into the disease,
we still have 250,000 people who don't know they have it," CDC
Director Julie Gerberding said Wednesday. "Our goal
is to help people to know their status and get treated."
Taken together, these programs also mark a major new trend
in AIDS prevention. With a $35 million push from CDC-- through
its initiative called "Advancing HIV Prevention: New
Strategies for a Changing Epidemic"-- HIV tests are
rapidly becoming a critical component of prevention efforts,
along with traditional programs designed to teach people
most at risk to protect themselves.
"Knowing one's HIV status is one of the most powerful
motivators of behavior change," Gerberding said. "Most
people who know they're HIV-positive take appropriate steps
to protect their partners."
By vastly expanding access to the newly approved test, which
is made by Orasure Technologies, the CDC hopes to reduce
the number of people who have HIV and don't know it. Of an
estimated 900,000 HIV-positive people in the USA, about 30
percent either have not been tested or never returned for
their test results. Many won't find out they're infected,
or seek treatment, until it's too late. CDC hopes to shrink
that population to just 5 percent of those who are infected.
"The most important aspect of this new, rapid test
is that each year 10,000 people in the U.S. test positive
but never return for their test results," says Mick
Ellis, director of testing and counseling for the Whitman-Walker
Clinic in Washington, D.C. "With the rapid test, we'll
be able to give them their results in 20 minutes."
[USA Today, 6/26/03]
HIV Cases Increase in Galveston County, Texas
Though Galveston County, Texas, has an HIV infection rate
lower than the state average, the number of new HIV cases
in the county increased last year. In 2002, 41 new cases
of HIV infection were reported in Galveston County, up from
19 new cases reported in 2001. Thirty-six cases were reported
in 2000. State law requires positive HIV tests at health
care facilities to be reported to the Texas Department of
Health.
While the increase appears to be significant, Dr. Sharon
Melville at the Texas Department of Health speculated that
cases from 2001 perhaps were not reported to the state until
the next year. "It's probably a little blip in how the
reports were processed. That wouldn't get me very concerned," said
Melville.
Although numbers for the beginning of 2003 have not been
released, Melville said the county's rates have traditionally
been slightly lower than the state average. Statewide, the
rate of new HIV infection is 22 per 100,000 people in 2002,
but it is 16.1 per 100,000 in Galveston County. "There's
not as many cases in Galveston County," said Melville. "That
doesn't mean it's not active in Galveston County. It just
means that infection numbers aren't quite as high."
The number of HIV cases, however, is distressing to Melville,
particularly "because of all the emphasis on prevention
activity." "We're still seeing new cases," she
said. Melville added that several different groups, most
notably African Americans and homosexual men, are more likely
to become infected.
[Houston Chronicle, 6/19/03]
FDA Approves First Once-daily Protease Inhibitor for AIDS
The government has approved the first once-a-day protease
inhibitor to treat HIV infection. Protease inhibitors are
a powerful type of drug that revolutionized HIV care in the
mid-1990s. While they're not a cure, protease inhibitors
taken together with older AIDS medicines suppress HIV enough
to allow many patients to stay far healthier for years longer.
But these so-called “drug cocktails” require
swallowing handfuls of pills several times a day.
The newest protease inhibitor, Reyataz, requires just a
once-daily dose of two pills, taken with food-- plus whatever
older medications patients take as part of their daily cocktail.
Six other protease inhibitors already are sold, but require
taking several pills two or three times a day.
The Food and Drug Administration approved use of Reyataz
as part of combination HIV therapy on Friday. Manufacturer
Bristol-Myers Squibb said the drug, known chemically as atazanavir,
would hit pharmacy shelves next month. The company refused
to reveal the price, saying only that it would be competitive
with other protease inhibitors.
Reyataz appears to work as well as other protease inhibitors.
But a common side effect of other protease inhibitors is
a rise in cholesterol-- and for some reason, Reyataz so far
doesn't appear to cause that problem, the FDA said.
However, up to 24 percent of Reyataz patients can experience
jaundice, a yellowing of the skin or eyes. It seems to quit
when patients stop taking the drug, and doesn't appear to
be associated with liver injury, the FDA said. Other side
effects include nausea, infection, headache and diarrhea.
[Associated Press, 6/20/03]
FDA Commissioner Aims for Faster Drug Reviews
The nation's top drug regulator said on Monday he aims to
cut the time it takes to bring new medicines to the public,
while still ensuring that any negative side effects are promptly
reported to the government. Speaking at the annual meeting
of the Biotechnology Industry Organization in Washington,
U.S. Food and Drug Administration (FDA) commissioner Mark
McClellan said the agency will soon announce new initiatives
to reduce the cost of drug development by cutting the time
the agency spends reviewing applications.
The agency will also work closely with drug developers to
ensure that new drug applications are properly organized
from the first time they are submitted, he said. That would
avoid time-consuming and costly setbacks such as the 2001
rejection of ImClone System Inc.'s application to market
its experimental cancer drug Erbitux because the agency was
unhappy with how the trials were conducted and the data were
organized. After the FDA's refusal, shares of ImClone sharply
declined, setting in motion an insider trading scandal and
delaying potential approval of Erbitux by at least two years.
Since taking the job in 2002, McClellan has repeatedly made
clear he intends to speed the drug review process. Over the
past six months, some half-dozen new drugs have been approved,
some unexpectedly, helping lift the American Stock Exchange
Biotechnology Index of biotech stocks more than 50 percent
since March. McClellan said he thinks the gain in the sector
is justified.
He noted, however, that while the FDA is "working hard" to
reduce the cost of drug development, biotechnology companies
must do their part to cut development time by devising new
research techniques. Reduced time for development, he said,
makes it more critical than ever that companies promptly
report any problems that arise from the use of new medicines.
"The FDA has always relied on a voluntary reporting
system for adverse events," he said. "The truth
is there are countless adverse events that go unreported."
He said he plans to institute systems to ensure that adverse
side effects are reported in a timely way. For instance,
McClellan said the FDA plans to introduce a real-time electronic
monitoring system that will help alert the agency of potential
risks with newly approved drugs.
Many drugs are approved on the condition that companies
conduct further clinical trials to monitor the drug's performance
in a wider population. Few companies actually conduct such
trials. "If we have this information, we can have more
confidence that potential problems will be identified," said
McClellan.
[Reuters Health, 6/24/03]
West Palm Beach AIDS Housing Program Under Investigation
Some managers of the Haitian American Community Council
are being investigated for steering AIDS clients toward landlords
with ties to the agency's employees, West Palm Beach City
Administrator Ed Mitchell said Tuesday. West Palm Beach launched
the inquiry last week following complaints an unspecified
number of managers may have had conflicts of interest in
placing clients in homes owned by the organization's employees
or their business acquaintances, Mitchell said. The city
oversees more than $300,000 a year in federal money given
to the council to provide housing for AIDS clients.
"The matters that came to the city's attention are
being investigated as to whether there was a conflict of
interest," said Samuel Thomas, a city attorney. Mitchell
declined to name the managers or the properties under investigation.
West Palm Beach is the third of the council's four government
financial backers investigating conflict-of-interest issues
with management of the Delray Beach-based organization.
The Palm Beach County Department of Community Services and
the Children's Services Council of Palm Beach County have
raised concerns in the past two weeks that the organization's
director, Daniella Henry, and former supervisor, Gethro Louis
Jean, bought a house together in West Palm Beach while they
were co-workers. Louis Jean also has operated an immigration,
personal-injury and translation service company, Legacy Service
Center, using the Haitian council's Lantana address while
he was working for the organization, according to state records
and Louis Jean's business card.
The two agencies placed the council under closer supervision
and required Henry and the five board members to affirm the
organization's conflict-of-interest policies. They also will
need to resolve other administrative problems, such as poor
record keeping, that were pinpointed by the agencies. The
county and CSC together give the Haitian group nearly $300,000
to provide clients with immigration assistance and social
services.
Haitian council board member Barry Silver said he didn't
know anything about West Palm Beach's investigation and couldn't
comment. Neither Henry nor board President Carolyn Zimmerman
could be reached.
Mitchell said the city's attorneys and finance and economic-development
officials are investigating the council's allegations with
support from the U.S. Department of Housing and Urban Development,
which gives the AIDS housing money to the city and oversees
it. West Palm Beach disburses the federal money to other
agencies providing housing for AIDS clients.
Mitchell didn't immediately know how many AIDS clients are
served by the Haitian council's program. The city also hasn't
yet released the names of the landlords affiliated with the
program.
The federal money overseen by the agency pays for all or
part of the clients' rental payments. The payments are supposed
to be paid to the landlord.
Mitchell said he wasn't sure when the inquiry will be completed. "We
are doing our background work to determine what happened
with our funds," Mitchell said.
If the city finds severe problems, it may consider dropping
the council and selecting another agency to oversee the money,
city officials said.
[Sun-Sentinel (Fort Lauderdale, FL), 6/25/03]
The HIV Update is a weekly report of articles, studies and
other information related to HIV/AIDS, sexually transmitted
diseases and related risk behaviors compiled from various
news sources by the Children’s AIDS Fund.
The Children’s AIDS Fund is a non-profit, non-partisan
organization dedicated to helping limit the suffering of
HIV-impacted children through direct assistance and resources,
as well as through technical assistance for their parents
and care-givers. For additional information, call (703) 471-7350.
Previous editions of the HIV Update are available on-line
at http://www.childrensaidsfund.org/news.asp.
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