delfines@enet.cu 
Havana, 28 November 2003

The World's First Synthetic Vaccine for Children:

The Cuban Face of Biotechnology

By Susan Hurlich


A new Cuban vaccine has just been announced against the
bacteria that causes meningitis and pneumonia primarily in
children up to five years of age. The breakthrough vaccine,
produced with an innovative technology that was jointly
patented in 1999 by the University of Havana and the
University of Ottawa, is also the world's first human
vaccine with a synthetic antigen.

During a keynote address at an international biotechnology
congress that just concluded in Havana, Dr. Vicente Verez
Bencomo, head of the University of Havana's Synthetic
Antigens Laboratory, said that after 14 years of research
and tests, the new vaccine is finally in production and
will become part of the country's national vaccination
program as of January 1st.

"The most important part of this project is that we're
contributing to the health of children," he said.

The Cuban expert explained that the vaccine protects
against Haemophilus influenzae type b (or Hib), a bacteria
that causes nearly 50% of all infections, some of which
lead to deafness and mental retardation, in under
five-year-olds worldwide. Annually, over 500,000 children
die from Hib.

"Only 2% of the world's children are currently protected
against Hib", says Verez, who studied chemistry in the
former Soviet Union and France.

Before 1988, when conjugate Hib vaccines were first
introduced, Hib disease was the most common cause of
bacterial meningitis in children in the U.S. By the early
1990s, a drastic reduction of over 95% was seen in the
incidence of Hib disease. But this vaccine, based on a
complex process using fermentation of bacterial culture,
was expensive to produce - making it virtually impossible
for poorer countries to obtain. As a result, most of the
deaths from Hib are now found in developing countries.

In January 1999, Cuba began its first national Hib
vaccination campaign, purchasing the expensive Hib vaccine
from overseas at a cost of US $3 per dosage. It's partially
because of this high cost that Cuba began searching for a
low-cost alternative that could be produced on a large
scale. But there are other reasons as well. As Verez says:
"What could be more precious for society than to have
healthy babies."

Biotechnology, Cuban style

How is a poor, third world nation such as Cuba able to
develop such a sophisticated vaccine? The answer is not
hard to find. Since the 1959 revolution, the cornerstone of
the country's social development has been education and
health care. From the 1980s on, the Cuban government has
invested well over US $1 billion to develop modern vaccine
laboratories and an immense biotechnology complex.

The results have been impressive: a meningitis
meningococcus groups B and C vaccine, a Hepatitis B
vaccine, the famous PPG which significantly reduces
cholesterol levels, monoclonal antibodies that prevent the
rejection of transplanted organs, recombinant interferon,
and now a low-cost synthetic Hib vaccine. There are also
presently 150 biotech patents in Cuba of which 66 are in
other countries, overseas quality certifications of Cuban
biotech products, technology transfers abroad, and a joint
project with GlaxoSmithKline for the introduction of the
meningitis B vaccine into Europe and possibly the U.S.
Today, Cuba exports pharmaceutical products to over 50
countries per year. Last year, annual sales totalled about
US $30 million.

The reason Cuba's biotech development has been so
successful is not only because of large government
investments. It's also in the organization and overall
orientation. Rather than functioning independently, Cuban
biotech and pharmaceutical industries are part of the
national health care system. With a focus on developing a
national research capacity based on Cuban scientists and
professionals, the first priority of biotech research is
the domestic market, meaning that the Cuban people
themselves directly benefit from the country's
medico-scientific expertise. This concern with the well
being of the local population goes hand in hand with
developing new medical products for export. The Cuban
biotech industry is also an integrated system from research
to post-marketing, and includes the development of spin-off
companies such as Heber Biotec S.A, responsible for
commercializing all pharmaceuticals both nationally and
internationally. Finally, Cuba's biotech industry is
characterized by national collaboration rather than
individual competition.

The development of the Hib vaccine is a case in point.
"It's a collective achievement of the accumulated
intelligence of our country", says Verez, explaining that
to produce this vaccine involved over 300 investigators and
technicians and several different Cuban biotech
institutions. The Synthetic Antigens Lab worked on making
the synthetic antigen, the Finlay Institute worked on the
protein carrier, the Centre for Genetic Engineering and
Biotechnology (CIGB) joined the two compounds and the
National Centre for Bioproducts bottles the vaccine in
dosage-size flasks which will be commercialized under the
registered name of Quimi-Hib.

Canadian Collaboration

Canadians can also feel proud that they too played an
essential and key role in contributing to develop the
world's first synthetic vaccine at a critical moment of the
process.

What is unique about the new Hib vaccine is that it's made
with a chemically produced antigen. An antigen is the
smallest substance that antibodies need to recognize so
that they can trigger the immune system to take action. A
vaccine produced from fermented bacterial cultures always
carries the risk, however slight, of infection by the
disease. But with a chemically-produced synthetic antigen,
the immune system is fooled into thinking it's being hit by
the actual bacteria and develops the necessary antibodies.
This is the beauty of synthetic vaccines: they're
completely safe.

So why has it taken so long to produce a synthetic vaccine?
Especially when Cuba's Synthetic Antigens Lab was only one
of approximately ten labs and companies worldwide which had
succeeded in developing the Hib synthetic antigen. The
answer has to do with the new technology involved in
producing the antigen.

Enter Canadian Professor Rene Roy who, when he first met
Verez at a 1994 International Carbohydrate meeting in
Ottawa, was on staff at the University of Ottawa. A year
later, Verez invited Roy to a similar meeting in Havana
-and the seed was planted for what was to become one of the
most fruitful scientific collaborations in the development
of the vaccine. The problem: how to innovate and simplify
the ongoing Cuban process of binding the phosphates in the
antigen in a way not pursued by its competitors for a
successful and a patentable approach. Headed by Roy, the
two chemists and their respective universities wrote up a
proposal that was funded by the World Health Organization
(WHO), and after two years of research the answer was
found.

"I figured out a way to do the phosphate bindings that
works like a continuous zipper, rather than doing the
bindings one at a time," explained Roy during an interview
last week at the biotechnology meetings.

This "zipper binding technique" was a novel discovery, as
it meant fewer steps - and hence a technology that was both
simpler and competitive with the existing conventional
technology - in preparing the antigen. Once the problem was
solved, the two inventors filed a patent first in Cuba, and
later in other countries. The discovery is co-owned on an
equal basis by the University of Ottawa and the University
of Havana.

After bonding the synthetic antigen, it was ready to be
joined with the protein carrier to produce a vaccine. But
before it could be considered a success, it had to be
tested.

Clinical Trials

Clinical testing of any vaccine involves three basic
stages: safety of the process, efficacy of the vaccine with
a limited population and finally, efficacy with the target
population.

From earlier tests on rabbits, the Synthetic Antigens Lab
already knew that the synthetic antigen was recognized by
the antibody system. They also determined that the
antibodies could kill the Hib bacteria. But now began the
most critical phase: testing the synthetic vaccine with
human beings.

"I was the very first volunteer," said Verez. "but when my
immune system showed no response after the first week, we
got worried. By the second week, though, the response was
good."

This phase of the work - clinical testing - was designed
and organized by the Havana-based "Pedro Kouri" Institute
of Tropical Medicine and CIGB, and monitored by Cuba's
Clinical Trials and Regulatory Affairs Department.
Internationally established procedures for testing vaccines
were used, such as the double blind method whereby neither
the administering nurse nor the subject (nor lab
technicians who later test the results) knows who gets the
vaccine and who gets the placebo, and using control groups
which receive the existing commercial vaccine. Cuban
specialists also visited the Federal Drug Administration in
Washington DC, to talk with American specialists in the
FDA's Centre for Biological Evaluation and Research about
how they evaluate vaccines.

Starting in 1999, seven independent clinical trials were
carried out on the new vaccine. The first two trials
involved adults, all volunteers - mainly from the Synthetic
Antigens Lab - divided into two groups of about 40 people
each. Then came two trials with four- and five-year-olds.
Written consent was required from both parents; if one or
both wanted to abandon the test and withdraw their child,
they were free to do so. In total, about 1,100 children
participated in these two trials. These and subsequent
tests involving children were done in the central province
of Camaguey, nationally recognized for its high level of
organization.

Finally came the tests with the target population:
two-month-old babies. Again, both parents had to agree. If
they did, their participation began before birth of their
child, so that the reason for the clinical tests could be
carefully explained and understood. A total of about 1,100
babies received the vaccine at two, four and six months of
age, making this the longest clinical trial of all.

"The trials with nursing babies were the most emotional of
my life," said Verez during a press visit to the lab "and
the strength of the parents was impressive for us to see."

The seventh and last trial, carried out with 18-month-old
toddlers - the same children from the two previous trials -
tested the final booster shot vaccine. The children were
found to be 100% protected, with their antibodies having
increased by a factor of ten. This was an important result
as it showed that the memory response of the vaccine was
working.

In May 2003, with all the data from the clinical trials
available, the result was conclusive: a 99.7% success rate
among all children in developing the required antibodies,
and at a level exceeding internationally recognized
standards of efficacy for human vaccines.

On November 6, the new Hib vaccine was registered in Cuba,
and, says Verez, it's in the process of being patented in
other nations. Preparations are also underway to have the
vaccine certified by WHO. If granted, the synthetic vaccine
would join the ranks of Cuba's Hepatitis B vaccine, which
since December 2001 has had a pre-qualification status from
WHO - the first vaccine in Latin American to receive this
recognition - meaning that it can participate in tenders
with WHO, the Pan American Health Organization, etc.

Production and Marketing

Today, Quimi-Hib is being produced in Cuba in a new modern
plant at CIGB which has been outfitted with
state-of-the-art technology. To date, some 300,000 doses
have been produced; for Cuba, it's estimated that about 3.5
million doses will be needed annually. But with overseas
sales a serious prospect, the plant has been designed to
eventually produce hundreds of millions of doses. And Heber
Biotec - which owns the license not only for selling
Quimi-Hib but for commercializing all CIGB products and
projects - is already starting to think through its
marketing strategy.

Yet even in its approach to marketing, Cuba offers an
interesting twist to the norm. "Our objective in developing
this vaccine is to lower infant mortality," says Dr. Carlos
Manuel Mella Lizama, vice general manager of Heber Biotec,
"not to make money. Of course, we can't give the vaccine
away. We must sell it. But money isn't the objective of our
biotech industry, it's the means."

Mella explains that some of Heber's overseas partners say
that Heber functions like a transnational corporation
because it has business relations in 60 countries and makes
US $30 million a year from sales. "But we're substantially
different from TNCs which serve under their own banners",
continues Mella, "because we work under the same banner as
our country and share social and human objectives rather
than purely financial ends."

To illustrate his point, Mella notes that the University of
Havana and the University of Ottawa have jointly agreed to
waive any royalties from the sale of Quimi-Hib either in
Cuba or in epidemic situations in developing countries.
"This decision is part of our struggle to defend children
in the Third World," says Mella. "If you don't care for the
children, you don't care for the future."

Canadian Rene Roy, who since January 2003 has been with the
Chemistry Department at the University of Quebec in
Montreal, echoes this sentiment. "I feel proud of this new
vaccine and of the fact that the end product of our work is
geared to infants."

And what of the future for Cuba's biotech industry? At
present, Cuba is working on 29 other vaccines besides Hib,
including developing an affordable alternative - perhaps
another synthetic vaccine - for protecting children against
pneumococcus, a disease which kills three million children
annually the world over. The existing vaccine, produced in
the U.S., costs US $250 for four doses. The overall
objectives of Cuba's vaccine projects are to treat masses
of people, provide protection, and make vaccines easily
accessible to poor countries.

***

GRANMA INTERNATIONAL
Havana. January, 29 2004

CUBAN AND U.S. PSYCHIATRISTS MEET IN HAVANA
We have a lot to offer each other

BY LILLIAM RIERA -Granma International staff writer-

THE United States can learn a lot from everything that's
been done in Cuba in the field of preventative medicine,
affirmed Charles B. Nemeroff, head of the Psychiatry
Department of Emory University in Atlanta, speaking in
Havana.

Dr. Nemeroff was one of 19 eminent U.S. researchers who
attended the 2nd Cuba-U.S. Workshop on Biological
Psychiatry in the Cuban capital.

Biological Psychiatry is the study of mental illnesses and
disorders that lead to widespread suffering and disability.

According to the World Health Organization, around 24% of
the productive years of life are lost as a result of
disorders such as these.

In this second workshop - the first took place in 1999 -
participants tackled subjects such as anxiety, stress,
depression, schizophrenia, and behavioral and learning
disorders. Although the meeting ended without a joint
declaration, there was definite interest on both sides to
develop action programs in specific areas.

Responding to a question from Granma International, Dr.
Mitchell Valdés Sosa, director of the Cuban Neuroscience
Center (CNC), noted that "work in the field of molecular
and cellular biology and research into illnesses such as
schizophrenia would allow significant cooperation between
both sides."

Both Nemeroff and Mark M. Rasenick, a researcher and
director of the Neuroscience Training Program at the
University of Illinois, advocated combining Cuban and U.S.
experiences in the near future as both sides have a lot to
offer each other.

The meeting provided useful exchanges of knowledge and the
results of research carried out in the respective
countries.

The CNC director gave a detailed explanation of an in-depth
study of mental retardation undertaken in Cuba as part of a
national program to help sufferers, which resulted in the
detection of some 140,489 individuals afflicted with this
condition; that is to say, 1.25 per 100 inhabitants.

The investigation continued over two years during which
time 366,864 sufferers were visited in their homes.

According to information supplied by the Cuban scientist
concerning the causes of mental retardation, "45%
corresponded to pre-natal factors" and of those, "15.9%
were of genetic origin." In terms of post-natal factors,
bacterial meningitis was mentioned.

"More than 76.87% of those individuals have received some
kind of education," affirmed Mitchell Valdés, who
highlighted that life expectancy amongst this group was "60
years or more."

The director also informed the meeting that Cuba has just
completed its first study on twins - involving 300 sets -
based on a similar piece of research from Denmark.

In the same way, he referred to research underway in
relation to conditions such as autism, ataxia, dementia,
Alzheimer's disease and schizophrenia, adding that Cuba has
more than 100 specialists working in the field of clinical
genetics."

Referring to the functioning of the Cuban mental healthcare
system, Guillermo Barrientos, a member of the Ministry of
Public Health (MINSAP) working group in this field,
commented on the reduction of suicidal behavior in Cuba.

Barrientos explained that "in 1984, the suicide rate stood
at 24.6 for every 1,000 inhabitants. Today, that has
dropped to 14.3". He revealed that there is a higher
incidence amongst people over 60 years of age."

"The report on suicidal behavior has allowed us to work
with individuals who are prone to this condition,"
emphasized Barrientos, explaining that "the focus of Cuban
public healthcare is towards the community."

CUBA TAKES PART IN BRAIN-MAPPING PROJECT

In a televised Roundtable discussion that formed part of
the Workshop's collateral activities, Dr. Pedro Valdés
Sosa, CNC's deputy director, stated that Cuba has agreed to
take part in a project similar to that of the Human Genome
program, but this time related to mapping of the brain.

He stated how, as part of this project, "neuro-images have
been taken of some 7,000 people in nine different
countries," adding that, "Cuba has already produced 72
images of normal subjects."

He added that amongst various technological possibilities
for visualizing the anatomy and function of the living
brain, increasing understanding of this organ's blood
irrigation or the functioning of its electrical activity,
Cuba has developed Cerebral Electrical Tomography as a way
of providing a more precise evaluation of patients arriving
in hospitals with cerebrovascular complaints.

He also explained that the International Neurological
Restoration Center (CIREN) in Havana is undertaking
research in the field of neuro-plasticity (the nervous
system's capacity to adapt its functions according to
imposed challenges), applying it to the rehabilitation
processes carried out there.

For the U.S. delegation, Dr. Rasenick explained to Cuban
television viewers the need to study the brain's biology at
a molecular and cellular level, in order to understand the
origins of mental disorders so that those suffering from
them can be treated like patents suffering from other
conditions.

Rasenick praised "the revolutionary progress" he had seen
on this island. He added whenever he visits Cuba he
witnesses new projects underway, or new equipment - either
bought or developed - being used, a fact he attributed to
the high level of intelligence amongst Cuban scientists.

The U.S. researcher affirmed that both nations would
benefit from the relationship and exchange that this kind
of event fosters.

Nemeroff, for his part, referred to the subject of
depression; a condition that often leads to suicide. He
commented on the very high suicide rate in the United
States, one of the principal causes of death in that
country.

CHILDREN UNDER STRESS == DEPRESSED ADULTS

He advocated working to guarantee that children develop
adequately and affirmed that abandonment and abuse during
childhood influence depressive tendencies in adulthood. In
the United States there are more than one million cases of
verified child abuse or maltreatment every year.

The Emory University professor has written an
internationally relevant book on the subject of
psychopharmacology, which he donated to Cuban research
centers.

Other U.S. researchers also presented the results of
important studies carried out in relation to stress, which
show that in response to this condition - one that affects
the whole human body - arterial tension, cardiac rhythm and
blood sugar levels are all negatively affected.

The experts explained, for example, that children who are
subjected to stress at an early age - as a result of sexual
abuse or abandonment - are more likely to suffer depression
and anxiety when they reach adulthood.

At the end of the event, Ismael Clark, president of the
Cuban Academy of Science (ACC), highlighted the need to end
the absurd U.S. policy on Cuba that restricts the free flow
of cooperation between scientific institutions in the two
nations. The ACC and the Cuban scientific community are
ready to continue developing the links established today
and in favor of furthering expansion in the future", he
affirmed.

For his part, Dr. Nemeroff stressed that they would work
hard in order to eradicate the barriers existing between
our two countries in order to achieve common goals. He
concluded by saying that they would start planning the next
meeting as soon as possible.

===============================================================

(http://business-times.asia1.com.sg/storyprintfriendly/0,4568,106947,00.html)


Business Times - 03 Feb 2004

OPINION
Japan just can't switch to gold - yet


By ANTHONY ROWLEY


WHETHER a studied statement, an off-the cuff comment or a veiled threat,
Japanese Finance Minister Sadakazu Tanigaki's suggestion last week that Japan
could diversify part of its huge foreign exchange reserves into gold has had
international reverberations.



It has brought home once more the fact that the vast dollar reserves which
Japan and the rest of Asia hold are a Sword of Damocles for the dollar and
the US Treasury market. The impact of such a move on the dollar would be
severe. And as Japan has a third of total US Treasury securities held outside
the US, the impact on the bond market would also be severe.


Mr Tanigaki's statement (in answer to a question in Parliament) that he felt
it necessary to take a view on the future composition of Japan's foreign
exchange reserves (the bulk of which are in dollars), and that this might
include a review of gold holdings, comes at a time when other Asian nations
have been expressing concern about their vulnerability to the dollar. It also
occurs when Asian central banks (the People's Bank of China for one, an
informed source told BT) are expressing strong interest in gold.


Asian monetary authorities are working too on laying the foundations for an
Asian Bond Market which would provide the infrastructure through which the
region could reduce its dependence on the dollar and the US Treasury market,
and provide a means for the region to deploy its own savings without
channelling them offshore.


Mr Tanigaki's comments were thus timely even if, as a senior Japanese
Ministry of Finance official claimed to this correspondent, it would be wrong
to infer any immediate action on Japan's part. There is, in fact, a powerful
argument why Japan cannot move out of dollars for the time being. This is
because it needs to buy dollars, rather than sell them, so long as it pursues
its current policy of also buying economic recovery through exports. The MOF
spent a record 20 trillion yen (S$321 billion) last year in propping up the
dollar against the yen and in the first month of 2004 alone it has spent an
incredible seven trillion yen more.


The dollars it acquires are then invested back into securities of the
dangerously indebted US government. This is an absurd situation, rather like
a shopkeeper lending ever larger amounts of money to an important customer
who is also a profligate spender, so that he can maintain consumption. The
customer signs ever-increasing amounts of IOUs or bills and the shopkeeper
has decreasing faith in these. But he cannot sell them so long as he retains
his dependence on keeping the customer happy. It is a delicate and dangerous
balancing act, and one might wonder why a Japanese finance minister should
risk upsetting it, as Mr Tanigaki did.


It may have been pure naivety. But it would be dangerous to bank on it. This
is not the first time that Japan has issued veiled threats to the US that it
is capable of retaliating if the exchange rate weapon is deployed (as
Treasury Secretary John Snow appears to be doing now through his policy of
benign neglect for the dollar).


There was an occasion in 1996 when former Japanese prime minister Ryutaro
Hashimoto pondered out loud during a visit to New York about what might
happen if Japan were to reduce its (even then) large holdings of US dollar
securities. Washington appeared to get the message and the severe upward
pressure that the yen had been subjected to eased off. Mr Tanigaki, according
to some schools of thought, may have been issuing a similar veiled threat
ahead of this week's G7 finance ministers' meeting in Florida.


Alternatively, the minister may have been floating a trial balloon to see
what impact it would have on the gold, foreign exchange and US Treasury bond
markets. As it happened, very little, even though as UBS commented, Mr
Tanigaki's remarks may be the biggest story in the official gold sector for
many years. The dollar paid more attention to hints by the US Federal Reserve
that it could raise interest rates sooner rather than later. The Treasury
bond market also seemed too preoccupied with domestic events to notice the
remarks.


The fact is, however, that at some time the threat of Asian governments
running down their colossal dollar holdings (which constitute the bulk of the
US$1.9 trillion of official foreign exchange reserves held in Asia) is going
to crystallise. It could happen if Japan's economy is moving, as some
economists suggest, beyond total export dependence towards a broader-based
domestic recovery. Or it could happen if rising US interest rates stall
growth and demand for imports. But happen it surely will and reshaping the
dangerous structure of mutual dependence between East Asia and the US should
be top of the agenda for the G7.


The writer is BT's Tokyo correspondent



Copyright © 2004 Singapore Press Holdings Ltd. All rights reserved.

 

================================================================

For Immediate Release: Tuesday, February 3, 2004
For More Information Contact: NBUF (713) 942-0365
THE BIG SIT-DOWN: REPARATIONS
NDABA III Comes To Houston

On Saturday, March 20, 2004 the Local Action Committee for Reparations
(LAC)
and the Society for the Study, Preservation and Dissemination of the
History
of Texas Southern University will host the BIG SIT-DOWN (NDABA III) for
REPARATIONS at Texas Southern University Health and Physical Education
Arena
(corner of Wheeler & Ennis, Houston, Texas) at 7:00pm (Doors Open 5:00pm).=

The
National Town Hall Meeting and Report to the People is FREE and open to th=
e
public. The NDABA or Big Sit-Down is a process designed to bring people o=
f
African descent together in unity around the demand for full and complete
reparations. A series of NDABA gatherings in other cities have focused on
unification and information sharing of many formations pushing the
reparations demand.
People will get a full understanding of reparations and the many differen=
t
tactics being employed to press this righteous call.
Among the many different local, state and national organizations scheduled=

to have representation at the BIG SIT-DOWN are: National Black United
Front,
Nation of Islam, National Coalition of Blacks for Reparations In America,=

New Black Panthers, Republic of New Africa, December 12th Movement, Malcol=
m
X
Grassroots Movement, Restitution Study Group, Sankofa Pan Afrikan Student
Organization, S.H.A.P.E. Community Center, Black United Fund of Texas, St.=

Saviors Church, Ta-seti African Historical Society, Shrine of The Black
Madonna,
Harambee Council of Elders, Africans and African-Americans for Enslavement=

Reparations, Local Organizing Committee, Citizens for A Better Media, Blac=
k
Heritage Society, Allen Parkway Village Residents Council In Exile, POWER,=

Mt.
Calvary Baptist Church, Sehah Youth Inc., San Antonio Millions for
Reparations, Atlanta Millions for Reparations, Afrikans United For Sanity
Now,
Mississippi Reparations Committee.
What Can You Do?
1. Plan to attend the Big Sit-Down Town Hall Meeting on Saturday,
March
20, 2004
2. Spread the word in your community
3. Make contributions to defray cost to National Black United
Front-Houston Chapter 2428 Southmore, Houston, Texas 77004
Contributors: National Black United Front, Nation of Islam,
African-American
News & Issues, Sehah Youth Inc., Black Heritage Society, Molly Stevenson.