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Saturday,
January 24, 2009
- Maryland /
Regional
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Private septic systems blamed for water pollution
(Baltimore Sun)
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Embryonic
tests in city possible
(Baltimore Sun)
- National /
International
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Infections May Indicate Deadly Bug's Comeback
(Washington Post
- Opinion
- ---
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- Maryland / Regional
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Private septic systems blamed for water pollution
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- Baltimore Sun
- Saturday, January 24, 2009
-
- Despite public concerns that Anne Arundel County's
pumping station overflows are responsible for the Chesapeake
waterways' high pollution levels, state and county officials
said yesterday that private septic systems are the main
source of high bacteria levels. Officials from the Maryland
Department of the Environment and Anne Arundel County
Department of Public Works spoke to the county's delegation
yesterday in Annapolis. Ronald Bowen, director of the
county's Department of Public Works, said that pet and
septic tank waste have contributed significantly to water
pollution. Tyeesha Dixon
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- Copyright 2009 Baltimore Sun.
-
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Embryonic tests
in city possible
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- By Matthew Hay Brown and Stephanie Desmon
- Baltimore Sun
- Saturday, January 24, 2009
-
- The U.S. Food and Drug Administration has given the
go-ahead for a California biotechnology company to inject
humans with embryonic stem cells for the first time -- a
turning point in the decade-long debate over whether the
potential of the cells to heal injuries and cure diseases
outweighs the ethical questions raised by their use.
-
- Geron Corp. plans to inject up to 10 recently injured
paraplegics with the living cells this summer and monitor
the patients throughout the year that follows. While the
purpose of the study is to determine whether the treatment
is safe, investigators also will be looking to see if it
works.
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- "Any return of bowel or bladder function, a return of
sensation or a return of lower extremity locomotion would be
a very exciting finding," Dr. Thomas B. Okarma, Geron's
president and chief executive, told reporters yesterday
during a conference call to announce the approval. The Menlo
Park, Calif., firm, which funded the University of Wisconsin
researchers who first isolated embryonic stem cells in 1998,
received permission to begin the Phase I safety study from
the FDA this week.
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- Newly inaugurated President Barack Obama has pledged to
broaden federal support for embryonic stem cell research,
but an FDA spokeswoman called the timing of the approval
"purely coincidental." Geron submitted its request last year
to begin testing the treatment, and is not using federal
funds for the trial. Obama has yet to appoint new FDA
leadership.
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- Dr. Peter Gorman, a professor of neurology at the
University of Maryland, said Maryland Shock Trauma Center
and Kernan Hospital are likely to be among the sites at
which the trial will be conducted. Gorman said he has been
in conversations with Geron for several months, and the
company has sent representatives to visit the facilities,
both in Baltimore. A spokesman for Geron said the test sites
have not been finalized.
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- Dr. Douglas Kerr, a neurologist at Johns Hopkins, called
the approval both "very big" and "really important."
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- "I hope it gets us some answers we can then build on,"
he said.
-
- Scientists see embryonic stem cells, which are able to
develop into any type of cell found in the human body, as a
potential source of replacement tissues that could be used
to treat a broad range of maladies, including Alzheimer's
and Parkinson's diseases, leukemia and spinal cord injury.
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- "Embryonic stem cells are really nature's own way of
making more of ourselves," Okarma said. "We are simply
harnessing the biology of normal human development in our
attempts to achieve permanent cure to chronic disease and
injury."
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- But harvesting the cells destroys the embryos, and so
has drawn opposition from the Roman Catholic Church and
others. President George W. Bush twice vetoed legislation
that would have broadened federal funding for embryonic stem
cell research.
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- Obama, who supported broader funding as a member of the
Senate, has said he would sign such legislation as
president.
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- The Maryland medical community, while enthusiastic about
yesterday's announcement, expressed concerns about the
planned trial. Kerr questioned the decision to study new
injuries, as opposed to chronic spinal cord problems. If
patients improve, he said, it will be difficult to know
whether it was because of the treatment or if they would
have improved on their own.
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- "Part of me worries that this may not be the best first
trial," he said. For the first subjects, Kerr would have
preferred a group of patients who would not have recovered
under conventional treatment -- such as children with spinal
muscular atrophy, who usually die before the age of 2.
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- "What Geron has tried to do is set expectations very low
-- this is purely a safety study," he said. "A likely
outcome is [the embryonic stem cells] will probably be safe
... but we won't have more of an understanding of the
biology of what these stem cells can do and their ability to
repair in human spinal cord injury."
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- Dr. Curt I. Civin, a stem cell pioneer at Hopkins, says
low expectations are appropriate.
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- "What they're really testing in this study is ... can
you give these stem cells to people and do they cause any
harm?" said Civin, who is to leave Hopkins next month to
become director of the new University of Maryland Center for
Stem Cell Biology and Regenerative Medicine. "We should
condition ourselves to grit our teeth and hope this is not
toxic."
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- Ruth Faden, director of the Berman Institute for
Bioethics at Hopkins, expects discussion of the moral and
ethical controversies surrounding the use of the cells. But
she wants attention paid to the welfare of those who agree
to participate in the trial.
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- "We have to be thinking about what's going to be
happening to these people," she said.
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- One concern is the safety of the cells being used, which
Kerr called "very powerful." The cells in the trial are
supposed to behave as nervous system cells, but he said it
is possible that "one or two or 10 or 100" could retain the
properties of embryonic stem cells -- meaning they could
continue to divide and differentiate in ways scientists
didn't expect.
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- "They can become anything," Kerr said, "and what if they
become the wrong thing?"
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- Okarma said tests involving more than 2,000 animals
showed that such differentiation did occur in some, but
added that it had "no clinical consequence. ... There's no
effect on the animal's life, mortality, and we've shown in
separate studies that these cells avoid recognition by the
human immune system."
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- The treatment showed benefits in rats, Okarma said. The
stem cells reinsulated damaged nerves, leading to
"improvement in locomotor activity."
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- "This approach is one that reaches beyond pills and
scalpels to achieve a new level of healing," he said. "We
hope to achieve the restoration, perhaps permanently, of
organ and tissue function by the injection of healthy
replacement cells."
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- In the human trial, to be conducted at up to seven
medical centers in the United States, patients will be
injected in the spine at the site of the injury. They will
be given anti-rejection drugs for the first 60 days and will
be followed for at least a year.
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- A successful trial could help shift the debate over
embryonic stem cells. Opponents have long argued that the
potential benefits have never been proved.
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- "Several politicians have said over the years, 'Tell me
when this is going to benefit a patient,' and then they'll
loosen the restrictions," Civin said. He expressed hope that
the trial would help provide an answer.
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- "Whether it's going to be a home run or the single," he
said, "I don't know."
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- Copyright 2009 Baltimore Sun.
-
- National / International
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-
Infections May Indicate Deadly Bug's Comeback
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- By David Brown
- Washington Post
- Saturday, January 24, 2009; A06
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- Federal health officials are concerned that a recent
uptick in so-called Hib infections in Minnesota infants may
signal a comeback of the deadly bacterium as a consequence
of a vaccine shortage and the reluctance of some parents to
immunize their children.
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- Minnesota recorded five cases of infection by
Haemophilus influenzae Type B last year, the highest number
since 1992, including three in November and December. The
death of a 7-month-old was the first Hib fatality in a child
there since 1991.
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- In two cases, parents refused to have their child
immunized. In a third, they asked to defer vaccination until
the child was 5, long after the shots are usually given.
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- "Parents need to know this disease is still around and
that it is very dangerous," Anne Schuchat, head of
immunization at the Centers for Disease Control and
Prevention, said yesterday.
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- "I can't emphasize how important it is to use this tool
in our toolbox," Ruth Lynfield, Minnesota's state
epidemiologist, said of the Hib vaccine, normally given at
2, 4, 6 and 15 months of age.
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- Hib can cause several types of infection, all of them
potentially fatal. Three of the Minnesota children had
meningitis, one had pneumonia and one had epiglottitis, an
infection of a structure in the back of the throat.
-
- Since the Hib vaccine became widely available in 1990,
infections have fallen by 99 percent nationwide. Minnesota
used to have 200 to 250 each year in children; now sometimes
there are none.
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- The five recent cases occurred independently, suggesting
that the microbe is circulating widely in the population and
is not just being passed in a high-risk environment such as
a day-care center.
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- Whether this is happening elsewhere and has just not
been noticed is the major unanswered question.
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- Minnesota traditionally has high vaccination coverage
and is not known for having a vocal anti-vaccine community,
as is the case in Oregon, Washington state Colorado, among
other places. It also has unusually good disease
surveillance, which could explain the discovery of the five
cases.
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- "We don't know whether this problem is occurring in
other states, but we really want to heighten the awareness
of this problem," Schuchat said.
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- A relative shortage of Hib vaccine may also be
contributing.
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- While two companies make the vaccine in the United
States, only one, Sanofi Pasteur, is now supplying the
market. The other producer, Merck, recalled its vaccine in
December 2007 because of questions about its sterility. The
company is not expected to be shipping vaccine again until
the middle of this year, a spokeswoman said.
-
- Because of the shortage, physicians have been asked to
defer the fourth dose of Hib vaccine, the "booster," unless
a child is at high risk for infection because of other
illnesses.
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- Although theoretically there is enough vaccine to
provide the first three shots for all American babies, a
Minnesota survey suggests that may not be true everywhere.
Infants there were nearly 20 percent less likely to have
received their three Hib shots than to have had three shots
of another vaccine (for diphtheria, tetanus and pertussis)
given on the same schedule.
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- In addition to the three children who were never
vaccinated, one of the Minnesota children received three
doses but was found to have an immune-deficiency disease
that increased risk. The fifth child had two doses.
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- Lynfield said that overall there appears to be a decline
in "herd immunity" to Hib in Minnesota -- the situation in
which the few susceptible children are protected by the many
immunized ones, who block the microbe from entering the
population.
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- The nation last year saw seven outbreaks of measles in
the United States and 140 cases, the largest number since
1996. One occurred in a San Diego charter school where about
35 percent of parents signed vaccine exemptions for their
children.
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- Vaccine refusal in Britain is now so widespread that
measles, once eliminated there, is endemic again.
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- Copyright 2009 Washington Post.
-
- Opinion
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- ---
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