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POLIO OUTBREAK IN
HUNGARY
Two new cases of poliomyelitis in
Bulgaria raise particular concern because they are caused by a wild virus, and
not by the strain used in vaccinations. Both cases occurred in the area close to
the seaport of Burgas. Both of the affected children belong to Bulgaria’s
gypsy population, the Roma, whose transient lifestyle increases the risk of
starting an epidemic. The time interval between each case was short, indicating
that the disease is spreading fast. Gene sequences of the strain responsible for
the two Bulgarian cases, match a wild type from India, suggesting that the
disease was imported in the region. Bulgaria had not had a case of polio caused
by wild type virus for more than ten years. Since the World Health Organization
(WHO) set up the Global Polio Eradication initiative, the number of cases of the
disease fell worldwide by 99%, from 350,000 in 1998 to about 2000 last year.
Europe was well on its way to being certified polio-free. (Certification
requires no new cases for three years, despite comprehensive surveillance).
The two Bulgarian cases, however, may call this into question and proves the
need for countries to maintain strong vaccination programs.
Source:
M. Schrope. Plan to eradicate polio hit by virus outbreak in Bulgaria. Nature
2001; 411: 405-406.
PROPOSAL TO SPEED
NEW DRUG APPROVAL IN EUROPE
On July 18, the European
Commission adopted a proposal that could cut the average time for the approval
of New Chemical Entities by half. Currently, the average approval time in Europe
is 18 months. If accepted, the proposal could make the drug approval process
faster in Europe than in the US. The new plan proposes to shorten deadlines for
various parts of the approval process, and introduces a fast track for
especially promising new treatments. To implement these reforms, the European
Agency for the Evaluation of Medicinal Products (based in London, UK), would be
given much broader responsibilities.
The plan must now be
approved by the Council of Ministers, which represents the 15 members of the EU,
and to the European Parliament. Both bodies will probably suggest amendments.
The approval process could take several years. Critics are concerned that
accelerating the approval process may endanger patients. They also warn that a
faster approval process will focus the agency resources on drug approval
draining them away from other public health needs. Proponents of the new plan,
however, say that it will not compromise safety, but rather cut out some of the
bureaucracy. The pharmaceutical industry has given the plan a cautious
endorsement.
Source:
Klarreich E. Drugs Approval Process gets speed treatment. Nature 412; 2001:364.
NEW
SCIENCE-POLICY GUIDELINES IN JAPAN
New science-policy
guidelines issued by Japanese prime minister Junichiro Koizumi on July 11,
emphasize the economic values of research and development, and call for
strategic focus on four key areas: life sciences, information technology,
environmental research, and nanothechnology. The guidelines have upset a number
of the country’s leading scientists, as they fear the guidelines will stifle
basic research. Some industrialists have also expressed reservations, claiming
that the government does not understand what the best research is, and should
therefore not be setting research goals.
Source:
Cyranoski D. Scientist fear new guidelines will stifle basic research. Nature
412; 2001: 364
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