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“Protecting the health and informed consent rights of
children since 1982.” BL Fisher Note: Just one vaccine manufacturer projects
vaccine sales growth from $4.9 billion in 2000 to $14.4 billion in 2010. The
enormous market for vaccines in the US is driven by mandatory vaccination laws
which guarantee predictable consumption every year while vaccine manufacturers
are protected from liability for vaccine injuries and deaths caused by mandated
childhood vaccines under the National Childhood Vaccine Injury Act. In any
discussion of mass vaccination campaigns to protect the US civilian population,
including children, against bioterrorist attacks using anthrax or smallpox vaccines
there must be open acknowledgement by industry and government that there will
be vaccine casualties. A serious attempt to minimize those casualties and
protect informed consent rights must go hand in hand with any mass vaccination
program.
Financial Times
Spreading calm in small doses
Rising public fear of biological warfare has prompted a dash
by companies to
produce vaccines, say Geoff Dyer and Clive Cookson
Published: October 11 2001 19:48 | Last Updated: October 11
2001 21:11
US soldiers were given a vaccine for anthrax during the
Gulf war but the policy was continued even after the end of that conflict.
Since then, more than 400 soldiers have risked court martial rather than take
the vaccine, which they claimed produced side-effects such as liver damage.
Following the September 11 attacks, the one factory in the
US that produces the vaccine has been inundated by civilians trying to buy a shot.
More generally, there has been panic buying of real and presumed antidotes to diseases
such as anthrax and smallpox.
Increased fears of biological attack on the US have
renewed interest in the biotechnology sector. Senators Edward Kennedy and Bill
Frist are calling for extra military funding of at least $1bn for protection
against bioterrorism.
This spending might not create a new branch of the
military-industrial complex. But it would be welcome for a sector that relies
mostly on venture capital - a source that has become much scarcer since the
bursting of the internet bubble. “The defence department is taking considerable
interest in biotechnology now, spurred on by the threat of bioterrorism,” says
Carl Feldbaum, president of the US Biotechnology Industry Federation and a
former Pentagon employee.
While European governments have generally played down the
threat of biological warfare, some US officials have added to the growing sense
of unease. According to Donald Henderson, the new chairman of the federal advisory
council on bioterrorism: “It is difficult for me to exaggerate the deficiencies
of our present public health capacities.”
The obvious beneficiaries are companies that supply
products related to the two most talked-about threats, anthrax and smallpox.
Bayer, the German group, is increasing production of its
antibiotic Cipro, which is active against anthrax and has been a hot seller at
US pharmacies in recent weeks. Meanwhile, Acambis, a UK biotechnology company,
has agreed to hasten delivery of 40m doses of smallpox vaccine to the US
government.
Because of the rarity of these diseases - smallpox was
officially eradicated in 1977 - there are few companies involved. Bavarian
Nordic, a Danish group, has been using smallpox vaccine as a basis for its
research to create vaccines for other diseases such as Aids and dengue fever.
It is now in talks with six governments about providing the smallpox vaccine
itself. “Most responsible governments
have been taking steps over the last few years to prepare for bio-terrorism,”
says Peter Wulff, the company’s chief executive. “That process is now being
speeded up.”
The other area attracting attention is detection,
equipment that can either warn of dangerous biological agents in the atmosphere
or rapidly identify DNA sequences of germs such as anthrax and smallpox. Beyond
the imme diate impact, the atmosphere created by the September 11 attacks is
likely to increase interest in two areas of the drugs business - antibiotics
and vaccines to treat or prevent infectious diseases - that were already expanding.
Experts have been warning for a number of years that
infectious diseases that many people in the 1960s thought had been eradicated
were making a comeback. These include relatively new threats such as the ebola
virus, along with well known diseases such as tuberculosis and yellow fever.
The rapid growth in international travel has made it easier for diseases to spread
swiftly around the world. Meanwhile, strains of old diseases are becoming
resistant to antibiotics.
“The attacks will speed up people’s interest in finding
smarter antibiotics,” predicts Mike Ward, analyst at Friedman Billings Ramsey,
a London investment bank. “Until recently this area had been the poor relation in
biotech, with more interest in cancer or the central nervous system but now it
is coming to the fore.”
Vaccines have also been attracting greater interest from
the drugs industry. A decade ago most
vaccines were cheap and mass-produced, which reduced the incentives for
research. However a few companies have succeeded in recent years in launching
prescription vaccines for diseases such as hepatitis.
This is another market boosted by increased travel to
exotic locations. Sales of vaccines
have grown faster than the overall pharmaceuticals market for the past decade
and will continue to do so over the next decade, analysts say. According to
GlaxoSmithKline, one of the largest vaccine manufacturers, world sales rose
from 1bn (pounds) in 1990 to 3.4bn(pounds) ($4.9bn) in 2000 (a compound rate of
13 per cent a year) and the company expects them to reach 10bn(pounds) by 2010.
The biotechnology and drugs industries are pushing the US
government to ease the regulations on vaccines to encourage more research, by
adopting fast-track approval processes and introducing the liability insurance
for adults that children’s vaccines currently enjoy. “If there is a silver lining
in this dark cloud we are in, it will be an increased focus on vaccines,” says
Mr Feldbaum.
Research in infectious diseases has also been invigorated
by the advancesin biology, especially genetics. This is giving scientists an
insight into the weak points of bacteria and viruses, which they hope to
exploit by developing a new range of drugs and vaccines. The complete gene
sequences - the genomes - of more than 30 bacteria are now known, says Julian
Parkhill, of the Wellcome Trust’s Sanger Centre, near Cambridge, England. Pharmaceuticals researchers are using genetic
information to identify enzymes and other biological molecules in bacteria that
can be blocked by drugs without affecting human hosts. The latest example is
the plague bacterium Yersinia pestis, whose genome was published last week.
Britain’s Defence Science and Technology Laboratory at Porton Down is already
using the genome to develop an improved plague vaccine.
The plague vaccine project is an example of way bacterial
biotechnology can have “dual use” in the defence and civil sectors. “It was
conceived as a vaccine to protect our armed forces if they should be exposed to
biological attack,” says Rick Titball, of Porton Down, “but it clearly has
applications for protecting civilian populations.” Scientists hope these new
developments will eventually calm an anxious public.
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