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December 20, 2009)
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December 14, 2009
Kate Kelland
The large international
trial of vaginal microbicide Pro 2000 in more than 9,000 women in four African
countries found no evidence that it reduces the risk of HIV infection.
The result is a setback
for the specialty drugmaker, whose shares were hit earlier in the month when
To date, no such gel,
known as a microbicide, has been shown to prevent HIV infection and this trial
"showed conclusively that Pro 2000 gel was of no added benefit," the
council said in a statement.
"This result is
disheartening, particularly in light of the results of a smaller trial sponsored
by the U.S. National Institutes of Health which suggested that Pro 2000 could
reduce the risk of HIV infection by 30 per cent," the council's Sheena
McCormack, who led the trial, said in a statement.
"Nevertheless we know
this is an important result and it shows clearly the need to undertake trials
which are large enough to provide definitive evidence for whether or not a
product works."
The findings also were a
setback to researchers trying to find a microbicide -- a gel or cream that women
and perhaps men can use to protect against the AIDS virus when their partners
cannot or will not use a condom.
Studies presented at an
AIDS conference in
Almost 60 million people
have been infected with HIV and 25 million people have died of HIV-related
causes since the beginning of the AIDS epidemic. There is no cure and no
vaccine, although drug cocktails can keep patients healthy.
United Nations data have
shown that globally that 33.4 million people had HIV in 2008 and 2 million
people died.
The latest trial, which
took place between September 2005 and September 2009, involved 9,385 women and
was carried out by the Microbicides Development Programme (MDP), a
not-for-profit partnership of 16 African and European research institutions.
It found that the risk of
HIV infection in women who were given PRO 2000 to use was not significantly
different than in women supplied with a placebo gel.
Jonathan Weber of the MDP
said the result was disappointing but added: "The trial itself was very
well designed and undertaken, so we know that the results are definitive.
"It is unfortunate
that this microbicide is ineffective at preventing HIV infection but it's still
vital for us as scientists to continue to look for new ways of preventing
HIV," Weber said in a statement.
Dozens of potential
microbicides are being tested, including a formulation using Gilead Sciences
Inc's HIV drug Viread, or tenofovir.
Fri, Dec 18 2009
By Julie Steenhuysen
CHICAGO (Reuters) -
They said a family of
genes act as cell sentries that guard cells from an invading influenza virus,
the team reported on Thursday in the journal Cell.
"This prevents the
virus from even getting into the cell," said Stephen Elledge of
"It is out there
fighting the flu all of the time," Elledge said in a telephone interview.
Elledge and colleagues
used a new research technique called RNA interference in which they
systematically turned off individual genes and then exposed cells to the flu
virus.
Using this method, they
discovered a small family of flu-fighting proteins called interferon-indicible
transmembrane proteins that boost the body's natural resistance to viral
infection.
"If you get rid of it
(the protein), the virus can replicate 5 to 10 times faster. What that means is
your cells have a mechanism that can block 80 to 90 percent of the virus that
gets in," Elledge said.
They also showed that if
they make the cell overproduce the protein, they become more resistant to the
flu. "If you crank it up, it really shuts down the flu," he said.
The team showed that a
specific protein in the family -- IFITM3 -- protected against several viruses,
including strains of influenza A now found in seasonal flu, the
The proteins did not offer
any protection against HIV or the hepatitis C virus, but lab tests suggested
they may defend against other viruses, including yellow fever virus.
The team showed that if
the virus evades this first-line protein defense and makes it inside the cell,
this activates an alarm system called the interferon immune response that gets
pumped out of cells and alerts the rest of the body to make more of the natural
antiviral proteins.
The findings offer new
insights into the body's natural defenses against influenza and other viruses,
Elledge said. "We really did not know how our bodies were stopping the
flu."
They also may lead to
better ways to protect people from influenza and other viral infections.
"By making this
protein be expressed in poultry or pigs, we can make them resistant to the flu.
That can help protect people by protecting animals from the flu," he said.
It also may lead to more
reliable vaccine production by creating a more friendly environment for the
virus to grow in chicken eggs, he said.
"If we take our gene
away from the cells in which the virus is growing, it will grow much faster. You
can actually produce vaccines much faster," he said.
By HOLBROOK MOHR,
Associated Press Writer Holbrook Mohr, Associated Press Writer Sat Dec 19,
12:22 am ET
Four people in three
states received organs from a patient who died at the University of Mississippi
Medical Center in November after suffering from neurological problems, said Dave
Daigle, a spokesman for the Centers for Disease Controls and Prevention.
Organs are routinely
tested for HIV, hepatitis and other more common infections, but occasionally
rare ones slip through.
"We test for the
known harmful diseases, but there's not a test for every single pathogen out
there," said Dr. Kenneth Kokko, medical director of kidney transplants at
UMMC.
Two of the recipients are
critically ill, but the others haven't shown symptoms, Daigle said. The CDC
confirmed the presence of the organism, known as Balamuthia mandrillaris, in one
of the recipients.
Dr. Shirley Schlessinger,
a UMMC doctor and medical director of the Mississippi Organ Recovery Agency,
would not say which states had patients receiving the organs.
The public should not be
concerned, both Schlessinger and Daigle said.
Balamuthia mandrillaris is
a microscopic parasite found in soil that causes encephalitis in humans, horses,
dogs, sheep and nonhuman primates. Scientists think people get infected by
breathing it in, but it can also pass into the blood through a cut or break in
the skin. It can be especially dangerous to people undergoing organ transplants,
whose immune systems are purposely weakened so their bodies don't reject their
new organs.
Human infections are very
rare: Only about 150 cases have been reported worldwide since the disease was
first identified in 1990. But it can be hard to diagnose because few
laboratories test for it and many doctors don't know about it. Some cases are
not identified until autopsy, according to the CDC.
"The thing we don't
want to happen is for people to take this rare and extraordinary anomaly and
think it speaks to a lack of safety," she said. "It's very rare so the
likelihood that this will happen again (is small), I mean, it's rarer than
rabies."
There are risks to
transplants and doctors can't test for everything, but the potential benefits
far outweigh the risks, she said.
Thu, Dec 17 2009
By David Freeman
Some experts have
speculated that removal of the foreskin might make sex less pleasurable for
women. But in the study, conducted in
The study, published in
the latest issue of BJU International, did not examine the effect of
circumcision on male sexual satisfaction. But one of the study's authors, Dr.
Ronald H. Gray, told Reuters Health in an email, "We previously reported on
this and found no effects on (male sexual) function or satisfaction."
The finding could help
curb the spread of HIV/AIDS by allaying widespread concern that women find sex
with circumcised men less satisfying. "The finding that circumcision does
not adversely affect female satisfaction should increase acceptability of the
procedure," said Gray, who is a professor of population and family planning
at the Johns Hopkins Bloomberg School of Public Health in
Previous research from
In an interview with
Reuters Health, Dr. Robert C. Bailey, of the
"In eastern and
southern
Bailey said the finding
might also help counter a growing reluctance of some parents to have their
infant sons circumcised. "In the
The study involved
interviews with 455 women between the ages of 15 and 49 before and after their
husbands underwent circumcision as part of a randomized trial of the procedure
as a means of preventing the spread of HIV/AIDS.
Only 13 of the women (2.9
percent) reported lower satisfaction after their partners were circumcised. Of
the remaining women, 255 (57 percent) reported no change in satisfaction, and
177 (39.8 percent) reported greater satisfaction. The differences in
satisfaction were unrelated to the women's age, religion, or level of education.
The women who reported a
change in satisfaction were asked to explain why.
The most common reason
given for increased satisfaction was better penile hygiene. Other reasons
included more frequent orgasms for the male partner; greater sexual desire of
the male partner; the male partner had less trouble maintaining an erection; and
the woman achieved orgasm more frequently.
The most common reason
given for diminished satisfaction was that the women's sexual desire had fallen.
Other reasons included lower male sexual desire; and the male partner had
trouble with erections.
SOURCE: BJU International,
December 2009.
Tue, Dec 15 2009
Pooling patents for
treatments for AIDS will make newer medicines available at lower prices for low
and middle-income countries, saving more than $1 billion a year, it said in a
statement late on Monday.
The patent pool could make
it possible to offer licenses systematically to generic manufacturers, reducing
prices and facilitating the combination of drugs from different makers into
fixed-dose or one-pill combinations.
"UNITAID has now put
in place a mechanism that will make medical advances work for the poor, while
compensating companies for sharing their technology," UNITAID Chairman
Philippe Douste-Blazy said.
Patented medicines are
often unaffordable for people in developing countries, as intellectual property
and trade rules prevent generics manufacturers in those countries from making
cheaper versions.
With AIDS the problem is
compounded by the fact that people infected with the HIV virus can develop
resistance to treatment and require newer medicines if the original drugs stop
working.
The patent pool will allow
manufacturers of generic drugs to make low-cost versions of widely patented new
medicines by creating a system for patent holders to license their technology in
exchange for royalties, UNITAID said.
This will spur competition
and bring down the price of new medicines, it said.
UNITAID said it had worked
with
UNITAID has identified 19
products from nine companies for potential inclusion into the pool.
The pool will help develop
fixed-dose combinations which mix drugs from different companies in a single
treatment, it said. Clinical evidence suggests these combinations are the best
way for patients to receive safe, effective treatment but patents have created
barriers to developing the combinations.
UNITAID will provide
start-up funds of up to $4 million over the next year to set up a licensing
agency to run the pool which will start operating in mid-2010.
Medical advocacy group
Medecins Sans Frontieres welcomed the move and called on drugmakers to
contribute patents quickly.
"Now that the pool
has been given a green light, patent holders need to move from expressions of
general support to firm and formal license commitments," its policy
director, Michelle Childs, said in a statement.
UNITAID is a
drug-purchasing consortium that provides long-term funding for the treatment of
HIV/AIDS, malaria and tuberculosis in developing countries.