Obama
made the announcement during a visit to the National Institutes of Health campus
in News (Updated
October 4, 2009)
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28 Sep 2009 17:14:36 GMT
Source: Reuters
*
Scientists confused by AIDS vaccine results
* Companies and
non-profits want to analyze the data
* Advocates see
billion-dollar market for HIV vaccine
By Maggie Fox, Health and
Science Editor
WASHINGTON, Sept 28
(Reuters) - More than 25 years into the AIDS pandemic, scientists finally have a
vaccine that protects some people -- but instead of celebrating, they are going
back to the drawing board.
The vaccine, a combination
of two older vaccines, only lowered the infection rate by about a third after
three years among 16,000 ordinary Thai volunteers. Vaccines need to be at least
50 percent effective, and usually 70 to 80 percent effective, to be useful.
Worse, no one knows why it
worked.
"Additional studies
are clearly needed to understand how this vaccine regimen reduced the risk of
HIV infection," Dr. Eric Schoomaker, surgeon general of the U.S. Army,
which helped pay for the study, told reporters.
Dr. Anthony Fauci,
director of the U.S. National Institute of Allergy and Infectious Diseases,
said, "We need to bring the best minds together and map the way
forward."
The vaccine is a
combination of Sanofi-Pasteur's <SASY.PA> ALVAC canarypox/HIV vaccine,
which includes synthetic versions of three HIV genes, and the failed HIV vaccine
AIDSVAX, made by a San Francisco company called VaxGen and now owned by the
nonprofit Global Solutions for Infectious Diseases.
"It is likely that
significant efforts will be needed to fully understand the study results and to
appreciate how they will inform the next steps to develop and deliver a safe and
effective HIV vaccine," Dr. Peter Kim, president of Merck Research
Laboratories <MRK.N>, said in a statement.
Merck's first AIDS vaccine
failed in 2007.
"I am not sure this
will encourage companies to immediately jump in," said Mitchell Warren of
the non-profit AIDS Vaccine Advocacy Coalition.
"What we hear from
pharma and from small biotechs is that they are fascinated by an AIDS vaccine
but as a business proposition, it is too risky."
The Thai trial may help
them re-evaluate,
MAKING A BETTER ONE
But first, some scientific
direction is necessary.
"What is needed there
is more in-depth analysis, to extend these findings, doing both clinical (human)
and preclinical (animal) studies to find out why it is working and how we can
make it better," Jim Tartaglia, vice president of research and development
at Sanofi, told reporters.
Companies and non-profits
along with governments have been working to make a vaccine against the human
immunodeficiency virus that causes AIDS. The fatal and incurable virus has
killed 25 million people and infects 33 million now.
Experts agree that a
vaccine is the only way to conquer it, but the virus mutates unbelievably fast,
can hide from the immune system and attacks the very cells sent to battle it.
To work, any HIV vaccine
would have to activate both arms of the immune system -- the antibodies that
home in on invaders such as viruses to neutralize them, and the T-cells that
recognize and destroy viruses.
This vaccine did not
appear to generate much of either response, and yet prevented infection 30
percent of the time.
Even more confusing, among
the 51 people who were vaccinated but were infected anyway, the virus thrived
just as well as it did among unvaccinated HIV patients. Researchers would not
have expected that -- they would have expected the vaccine to at least make the
infection less serious, as influenza vaccines do, for example.
Fauci wonders if the
vaccines stimulated some component of the immune system that has been
overlooked.
RENEWED HOPE
Dr. Donald Francis, a
former government vaccine expert who helped develop AIDSVAX and who helped found
Global Solutions for Infectious Diseases, said his team would be developing
smaller studies to answer some of these questions. "We have a limited
amount of vaccine now," Francis said.
The findings do offer
renewed hope for finding a better vaccine. "There are now six approaches
that look better than Merck's vaccine in the best of the animal models,"
said Dr. Seth Berkley, head of the International AIDS Vaccine Initiative, which
funds studies.
IAVI believes the rewards
could be substantial -- not just stopping the worst pandemic of our times, but
financially.
"At its peak, an HIV
vaccine could represent 5 percent to 13 percent of the total global vaccine
market," IAVI estimates.
At $2 a dose for the
developing world and $100 in richer countries, IAVI estimated companies might
bring in $1.6 billion to $3.8 billion a year with an HIV vaccine.
Yet the private sector
accounts for just 10 percent of all AIDS vaccine research and development
funding, the group estimates. (Editing by Mohammad Zargham)
Tuesday, September 29,
2009
A dearth of new products,
new technologies and fresh commitments by governments scrambling to protect
their populations from pandemic threats have lured
Three big
Johnson & Johnson ,
the world's largest healthcare company by market value, spent $444 million
(278.5 million pounds) to buy a stake in Dutch biotech company Crucell as part
of a new push into influenza vaccine and drug development.
Abbott Laboratories Inc
spent $6.6 billion to buy the drugs unit of
And Merck & Co ,
already a vaccines powerhouse with its shingles and cervical cancer vaccines,
got back into the
Although analysts say the
deals are more strategic than game-changing, collectively they have infectious
diseases experts heaving a sigh of relief.
"I am very pleased.
For a while, a lot of vaccine manufactures simply disappeared," said Dr.
Hildegund Ertl, who directs the vaccine centers at the Wistar Institute in
"There was this
attitude 20 years ago, 'Let's not worry about microbes. We've conquered them.
Let's focus on cancer.' Then HIV came along. Then SARS came along. Then H5N1
(avian influenza) came along," she said.
Ertl said beginning with
an outbreak of bird flu in Hong Kong in 1998, the
That has continued with
the current H1N1 swine flu pandemic that started in June. The
OUT TO GET US
"I think it's finally
sinking into politicians' minds that maybe viruses and pathogens are out to get
us and that our infrastructure has really gone to hell," Ertl said in a
telephone interview.
"We have very few
vaccine manufacturers in this country," she said, noting that companies
like Wyeth , which is being acquired by Pfizer , dropped out of the flu vaccine
market in the
Five companies make swine
flu vaccine for the U.S. market, all ultimately owned outside the United States
-- AstraZeneca's MedImmune unit, CSL, GlaxoSmithKline , Novartis and
Sanofi-Aventis .
"The government is
now pitching in to try to get interest back, to have more manufacturers make
vaccines," Ertl said.
Both Wyeth and Merck once
made influenza vaccines in the
"They decided it
wasn't worth it," said Dr. Robert Balshe, director of
For example, instead of
chicken eggs, Solvay makes flu vaccine in cell culture, and Crucell is
developing "flu-mAb," an antibody treatment meant to provide
protection from all influenza A strains as well as to treat patients who are
already infected.
Balshe said the
John Sullivan, director of
research and healthcare strategist at Leerink Swann, said all three deals
reflect the fact that the pharmaceutical industry has too few products, but
"lots of cash and lots of cash flow."
But he said the deals do
suggest a change in direction.
"These deals indicate
that infectious disease is perhaps moving up the list of what the managements of
some big therapeutics companies care about," Sullivan said in a telephone
interview.
He said the swine flu
pandemic has made clear that governments are more willing to pay for products
that protect their populations than before.
"If you look at some
emerging countries --
(Editing by Maggie Fox and
Cynthia Osterman)
September 30, 2009
Obama
made the announcement during a visit to the National Institutes of Health campus
in
"We know that this
kind of investment will also lead to new jobs: tens of thousands of jobs
conducting research, manufacturing and supplying medical equipment, and building
and modernizing laboratories and research facilities," Obama said in
remarks released by the White House.
The awards will focus on
medical and clinical research in several areas, including HIV-AIDS, (A) H1N1 Flu
and cancer.
Obama's 787-billion-dollar
stimulus plan passed by Congress in February, contains a mix of tax cuts and
infrastructure spending, designed to create millions of jobs and pull the
New Mexico Health
Department study finds high rate of hepatitis C infections among truckers
The medical director for
the department's Infectious Diseases Bureau, Steve Jenison, says studies in
other countries have linked the spread of sexually transmitted disease to long
distance truck drivers, but little is known about the industry in the
Jenison says researchers
learned that truckers passing through
Researchers examined
sexually transmitted infections, HIV and hepatitis B and hepatitis C virus
prevalence and risk behaviors among 652 truck drivers at 11 truck stops in
30 Sep 2009
JOHANNESBURG,
30 September 2009 - More than four
million people globally are now on antiretroviral (ARV) treatment - a 10-fold
jump in five years - but this is still less than half the people living with HIV
who need it.
A new report, Towards
Universal Access, was released on 30 September by the World Health Organization
(WHO), UNAIDS and the UN Children's Agency (UNICEF), and is the third annual
review of international progress towards the Millennium Development Goal of
universal access to treatment and prevention by 2010.
At the end of 2007 about
three million people were receiving life-prolonging ARV medication; in 2008
there was a 36 percent increase in people accessing treatment.
Dr Stella Anyangwe, the
WHO country representative in
"Reaching the 700,000
mark [of people accessing ARVs] is something we hadn't really envisaged when we
started providing treatment," admitted Dr Nono Simelela, CEO of the South
African National AIDS Council. However, with an estimated five million people
living with the virus - the highest caseload in the world - the country would
have to "push really hard" to achieve universal access to treatment.
Anyangwe attributed the
huge jump in global treatment access to a rise in the number of people being
tested for HIV as well as lower drug prices, especially first-line treatment
regimens, which had dropped by as much as 40 percent. The report noted that 94
of the 101 countries surveyed in 2008 were providing free HIV testing at public
sector health facilities.
Despite these achievements
there were still some major obstacles: people were still often tested at a late
stage of the disease, and only accessed treatment when they were very ill and
their immune systems could not recover. Also, "supply chain management is
still an issue ... some countries are experiencing stock-outs [of drugs],"
Anyangwe said.
One of her biggest
concerns was the widening treatment gap - about 9.5 million people are in need
of ARVs, but only 4 million are getting them. "At the rate we are going,
with new [HIV] infections rising it will be almost impossible ... to keep
providing free treatment to those who need it," she warned.
Countries should start
looking at financing their own treatment programmes, rather than relying heavily
on external funding. "If we keep people alive for longer ... then they may
be able to buy their own treatment," she suggested.
Prevention still the
weakest link
Despite the remarkable
progress made towards achieving universal access to treatment, countries were
still lagging behind when it came to prevention.
In 2008, 45 percent of
pregnant women in low- and middle-income countries received treatment to prevent
mother-to-child transmission, up from 35 percent in 2007, and far beyond the 10
percent reached in 2004.
However, the number of new
infections was still extremely high. "Not enough is being done to balance
two new infections for every person getting on treatment," said Mark
Stirling, regional director of UNAIDS Eastern and
More than 2.7 million
people became newly infected in 2007 alone.
Nevertheless, most
countries in East and Southern Africa had made a "quantum shift"
towards universal access to prevention, and several countries in
Yet all too often
vulnerable populations were still faced technical, legal and socio-cultural
barriers when trying to access HIV/AIDS services. Only 30 countries provided
needle- and syringe-exchange programmes for injecting drug users, and the number
of syringes distributed annually by these programmes was still well below the
internationally recommended target of 200 syringes per injecting drug user per
year.
The report concluded that
"Without significant acceleration in the rate at which services are
expanded and people are reached, millions of new infections will occur, more
lives will be lost, and the human and economic burden on future generations will
continue to increase."
01 Oct 2009
Caritas Internationalis
and the U.S. Embassy to the Holy See are holding a conference on preventing and
combating AIDS and TB in young children in
Up to 800 children die a day from AIDS-related illnesses such as TB. Many die in
poor countries where a lack of money contributes to difficulties in diagnosing
and treating children with HIV and in preventing transmission of the virus from
their mothers.
Rev. Msgr. Robert J. Vitillo, Caritas Internationalis’ Special Advisor on
HIV said, “An unacceptable number of children infected with HIV are dead
before they reach their second birthday. The world must wake up to this terrible
tragedy. It must invest money and expertise to keep HIV positive children alive.
“We need to help their mothers receive treatment so that they will not
pass on the virus to their infants, we need to test children earlier, and we
need “child friendly�
medicines and dosages to keep these children healthy.�
The conference will gather together leading voices from the UN, the Vatican,
NGOs, drug companies and professionals dealing in AIDS child care to look at
strategies to provide greater access to prevention, diagnosis and treatment for
children with or at risk of HIV and TB.
U.S. Ambassador to the Holy See Miguel Diaz said, “The
Other co-sponsors of the conference are the Pontifical Council for Health Care
Workers, UNAIDS, the World Health Organization Stop TB Department, the Stop TB
Partnership, the Health Commission of the Unions of Superiors General and Rome’s
Bambin Gesù Children’s Hospital.
“The co-sponsors of the conference have much influence from the highest
corridors of power to the poorest communities. With this type of partnership we
can make a great difference to the lives of children living with HIV,� says Msgr. Vitillo.
The event comes just ahead of the 20th anniversary of the Convention on the
Rights of the Child in November, which states that every child has the right to
life, the right to the highest attainable standard of health and access to
health facilities.
Caritas Internationalis launched the HAART for Children campaign earlier this
year to call for more action from governments and pharmaceutical companies to
help save the lives of children with or at risk from HIV.
30 Sep 2009
MSF and podcasts: The
international medical humanitarian organisation, M�decins Sans Fronti�res (MSF) is calling on
nine of the world's largest pharmaceutical companies to help accelerate the
availability of new treatments for millions of people living with HIV/AIDS by
pooling their patents on a list of key HIV medicines.
A patent pool is a
mechanism whereby a number of patents held by different parties are brought
together and are made available to others for production or further development.
The patent holders receive royalties paid by those using the patents. The
mechanism has been instrumental in promoting innovation in industries such as
aeronautics and digital telecommunications.
"It's a simple idea -
companies share their knowledge in return for fair royalty payments," says
Michelle Childs, Director of Policy & Advocacy at MSF's Campaign for Access
to Essential Medicines. "But it has the potential to transform companies'
approaches to access to HIV medicines and foster innovation in a way that marks
an alternative to the confrontation and litigation of the past."
UNITAID, the international
drug purchasing agency, is currently establishing a medicines patent pool for
HIV drugs. Critical to its success will be the willingness of patent owners to
participate by including their patent rights in the pool.
"The scheme is
voluntary so companies have a choice, and today we're asking them to make that
choice," says Childs. "This is an opportunity for these drug companies
to demonstrate that they are genuinely committed to effective measures that
allow access to life-saving medicines for people with HIV in developing
countries. Some companies have expressed interest in the idea, but we need them
to go further and put key patents in the pool."
For people living with
HIV/AIDS, the impact could be considerable. A patent pool could speed up the
availability of more affordable versions of new medicines, as generic production
could begin well before the 20-year patent terms expire. Currently, patent
barriers can also prevent innovation such as new paediatric formulations or
much-needed fixed-dose combinations.
"This opportunity
comes at a crucial time," says Dr. Eric Goemaere, medical coordinator for
MSF in
MSF is launching an e-mail
writing campaign calling on Abbott Laboratories, Boehringer Ingelheim,
Bristol-Myers Squibb, Johnson & Johnson, Gilead Sciences, GlaxoSmithKline,
Merck & Co, Pfizer and Sequoia Pharmaceuticals to meet the promise afforded
by this mechanism and put their HIV drug patents in the pool. The drugs that MSF
identified to be essential for the pool based on its field experience are all
recommended by the World Health Organization for use in developing countries.
Only selected MSF
documents are posted on Alertnet.
01 Oct 2009
By Susan Heavey
WASHINGTON, Oct 1
(Reuters) - Female Health Co's <FHCO.O> new version of its female condom
is now available to state health agencies and nonprofit organizations, but the
company is still trying to make it more widely available in stores.
The condom, known as FC2,
will cost about 30 percent less than the original version at less than a dollar
apiece, the company said on Thursday.
FC2, approved by the U.S.
Food and Drug Administration in March, will be available at Washington,
D.C.-area CVS stores in December, Female Health's senior strategic adviser Mary
Ann Leeper told Reuters. Female Health is still seeking a marketing partner to
help advertise and sell the product and is in talks with several companies, she
added.
"We need the other
company to really make a dent into the consumer market," she said.
The original female condom
never had a large following in the
But the female condom is
used widely overseas, especially in countries hard-hit by HIV, where women see
it as a way to protect themselves even if their male partners won't. The U.S.
Agency for International Development, which lobbied for the FC2's approval, has
said it plans to distribute it for global programs that aim to curb HIV.
While FC2 may face an
uphill battle at the retail level, it could see greater use with its new lower
price.
The original female condom
retailed for as much as $4 each. The new material and manufacturing have lowered
the price of the new version from distributors to no more than 82 cents per
condom, the company said. Male condoms, available in a variety of brands and
styles, can cost as little as 50 cents apiece.
Representatives for CVS
Caremark Corp <CVS.N>, which operates CVS stores, could not be immediately
reached for comment.
Shares of Female Health
were down 5.7 percent to $4.76 in afternoon trading on Nasdaq. (Reporting by
Susan Heavey; Editing by Tim Dobbyn and Gerald E. McCormick)