Maryland / Regional
Worcester to open
1st dental clinic
(Salisbury Daily Times)
Healthier Maryland Mothers, Healthier Maryland Babies
(Centers of Disease Control)
7 county
nursing homes earn top marks
(Capital News)
Cardin asks EPA
for new fly-ash rules (Capital News)
Rabid
raccoon second case in Mineral County
(Cumberland Times-News)
Nursing home
sold to Allegany HealthCare
(Cumberland Times-News)
Accused doctor's
license revoked
(Salisbury Daily Times)
Bay's health
not getting better, EPA says
(Baltimore Sun)
Stem cell
funding, tuition freeze favored
(Baltimore Sun)
FDA panel favors benefits of experimental J&J anticlotting drug,
despite bleeding risks
(Baltimore Sun)
National / International
Economy May Test Census
(Washington Post)
Nestlé's Inspectors Saw Rat Droppings, Rejected Peanuts (Washington Post)
Raw Milk Is Gaining Fans, but the Science Says It's Dangerous
(US News and World Report)
Opinion
False
teeth
(Baltimore Sun)
Maryland / Regional
Worcester to open
1st dental clinic
By Jenny Hopkinson
Salisbury Daily Times
Friday, March 20, 2009
OCEAN CITY -- Worcester County's first public dental clinic is
expected to start seeing patients in March, bringing much-needed
oral health to local low-income children.
And in a county recognized by Maryland Office of Oral Health as
having one of the highest rates of tooth decay in the state, the
almost $800,000 project may be long overdue.
The Worcester County Health Department is finalizing plans to
renovate the old Berlin senior center for the state-funded
clinic that will provide dental services to children on Medicaid
and support preventative measures in the community. Currently,
of the 22 dentists in the county, only one will see low-income
patients.
However, while the clinic is necessary for the 14.8 percent of
county children who did not have access to a dentist as recently
as 2004, many think there are other preventative measures
governments could be doing. The Ocean City/Assateague Democratic
Club voted Wednesday night to lobby local officials to
fluoridate the public water systems.
According to county Health Officer Debbie Goeller, Worcester has
the lowest percentage of people on fluoridated water systems in
the state.
"It's a political issue," Goeller said. "Until enough people say
we want it, we won't get it."
While putting fluoride in public water has been proven to reduce
dental problems in children, there are several issues facing the
initiative in Worcester County. To begin with, many homes,
businesses and even schools are served by wells, leaving it up
to the owners to do something about it.
As for the public water systems, Goeller said, the seasonal
nature of the county, concerns about cost and objection to any
additives have created local resistance.
The water in Ocean Pines, for example, has never been
fluoridated, because the creators of the originally seasonal
community didn't see the need.
Copyright 2009 Salisbury Daily Times.
Healthier Maryland Mothers, Healthier Maryland Babies
Centers for Disease Control Data Shows Progress
Maryland’s Focus on Prevention and Access Credited
Centers for Disease Control
Friday, March 20, 2009
Baltimore, MD (March 20, 2009) - There is good news for babies
born in Maryland, says the Maryland Department of Health and
Mental Hygiene (DHMH). The number of babies born prematurely
(before 37 weeks of pregnancy) dropped by over 4 percent from
2006 to 2007 according to the Center for Disease Control’s
National Center for Health Statistics. Premature births were
down in all racial and ethnic groups in the state. Similarly,
the percentage of low birth weight babies (born at less than
2500 grams or 5 ½ pounds) in Maryland fell by over 3 percent in
2007.
“These key indicators show that the health of Maryland’s mothers
and their babies is improving ahead of the national curve,” said
DHMH Secretary John M. Colmers. “Yet, we know there is much more
to do to ensure every pregnant woman gets the care she needs so
every child has a healthy start in life.”
The latest 2007 numbers suggest that Maryland program, “Babies
Born Healthy” is having a positive impact. Maryland’s broad
public health initiative increases access to health services for
women before they become pregnant, improves patient safety for
mothers and infants in Maryland hospitals, establishes strong
standards for obstetrical and neonatal care, and promotes access
to high-risk pregnancy care through partnerships with the
state’s academic medical centers.
Compared to Maryland’s numbers, both premature births and low
birth weight dropped by just 1 percent nationally in 2007,
according to the CDC’s Vital Statistics Report of Preliminary
2007 Birth data. The decrease seen in Maryland’s premature and
low birth weight babies is significant because these are the
leading causes of infant deaths in the first year of life.
“This confirms that Maryland’s comprehensive approach is making
a positive difference,” says DHMH Deputy Secretary for Public
Health, Frances Phillips,. “Our goal now is to extend this
success to improve the health of every pregnant mother and
newborn in Maryland. Also, we must we regain the progress we’ve
seen in recent years in reducing teenage births.”
Unfortunately, some teen birth rates increased slightly in 2007
- both in Maryland and across the United States - according to
data also released by the CDC. Teen births in Maryland remain
well below the national average at 33.6 births per thousand
females age 15 to 19, compared to 41.9 per thousand nationwide.
In the youngest age group, age 10 to 14, births fell in Maryland
in 2007 while they remained stable nationally. Although teen
births have increased slightly for the past two years, there has
been a substantial decrease since 2000. Maryland teen births
have fallen 17 percent since 2000, with a 12 percent decline
nationally over the same period.
For more information and access to the CDC’s National Vital
Statistics Report, Preliminary 2007 Birth data, go to:
http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_12.pdf
--Centers for Disease Control.
7 county nursing
homes earn top marks
Families rate level of care at facilities in statewide survey
By Shantee Woodards
Capital News
Friday, March 20, 2009
Seven nursing homes in Anne Arundel County either met or
exceeded statewide averages for overall satisfaction, a new
survey of the facilities found.
The Maryland Health Care Commission yesterday released the 2008
Nursing Home Experience of Care Survey, which allowed families
to rate their relatives' facilities.
Statewide, 228 nursing homes participated, including 15 in Anne
Arundel County and one in Queen Anne's County. This year's
survey had a 59 percent response rate and will be used as part
of the Maryland Nursing Home Guide.
"Although we are pleased that the average statewide scores are
high, there is substantial variation across nursing homes," Dr.
Rex Cowdry, the commission's executive director, said in a
prepared statement. "One of our major goals in public reporting
is to encourage improvements in care, particularly in nursing
homes with lower scores."
Survey respondents were asked to provide a numerical rating
between one and four in five categories:
Staff and administration.
Care provided to residents.
Food and meals.
Autonomy and resident rights.
Physical aspects.
The facilities also received an overall rating of care between
one and 10 and an area indicating whether the family would
recommend the facility to others.
This survey is not the only way to evaluate a nursing home. In
December, the Centers for Medicare and Medicaid Services
published its own scores for 16,000 nursing homes in the United
States, including 15 in the county.
The federal review had different results in some areas.
For example, Hammonds Lane Center in Brooklyn Park and Heritage
Harbour and Health and Rehabilitation Center in Annapolis earned
"much below average" scores for overall ratings in the Centers
for Medicare and Medicaid Services survey. But the state
commission study had Heritage Harbour meeting state averages in
two categories, with 86 percent of respondents willing to
recommend it to others.
Hammonds Lane met the state average in the staff and
administration category and had 76 percent recommending it to
others in the commission's survey.
On the commission's survey, seven Anne Arundel County facilities
- Crofton Convalescent and Rehabilitation Center, Fairfield
Nursing Center Inc. in Crownsville, Genesis HealthCare-Severna
Park, Genesis HealthCare-Spa Creek Center, Ginger Cove, Glen
Burnie Health and Rehabilitation Center and Knollwood Manor
Nursing Home - either met or exceeded the state's overall
satisfaction average of 8.2.
There also was a statewide average of 89 percent of respondents
who would recommend their facility to others. In the county,
seven facilities met or exceeded that level - Crofton,
Fairfield, Genesis HealthCare-Severna Park, Genesis
HealthCare-Spa Creek Center, Ginger Cove in Annapolis, Glen
Burnie Health and Rehabilitation Center and the South River
Health and Rehabilitation Center. Genesis HealthCare-Spa Creek
received a 100 percent score for being recommended, the only one
in the county to do so.
One facility - The Arbor at Baywoods of Annapolis - did not get
enough responses on any category to generate a score in either
the 2008 or 2007 survey. The Queen Anne's County facility,
Genesis HealthCare's Corsica Hills Center in Centreville, met
the state average in only the staff and administration category.
The Crofton Convalescent and Rehabilitation Center had several
scores similar to the 2007 survey and exceeded the state
averages in two areas. There were 96 percent of respondents who
said they would recommend the facility to others.
"We work really hard every day and we're humbled by the
excellent results," said Philip Gordon, administrator of the
Crofton facility. "We have a lot of longevity here ... we're on
the floors every day to make sure everything is going as good as
it can."
At Genesis HealthCare-Severna Park, the patients are used to
taking surveys. Aside from the commission review that went to
relatives, Genesis HealthCare uses an independent contractor to
gather feedback from families in all of its facilities. The 2008
commission survey gave the Severna Park facility results that
were similar to their own survey, officials said.
"We believe surveys like this are really important because we
believe customer satisfaction is a key indicator of the quality
we provide," said Patricia Mays, senior administrator. "The
longevity (and retention) of our staff is excellent. I have 15
staff members who have worked here more than 20 years and I've
been here for nine years. When you get staff who stays (in it)
as long as we have, the residents end up becoming your family,
more than customer service."
Survey results are available at
http://mhcc.maryland.gov/consumerinfo/nhguide/default.aspx.
Copyright 2009 Capital News.
Cardin asks EPA
for new fly-ash rules
By Joshua Stewart
Capital News
Friday, March 20, 2009
A resolution before the U.S. Senate would ask the Environmental
Protection Agency to create new rules for fly ash, a byproduct
of burning coal in power plants that contaminated drinking water
wells in Gambrills.
The resolution, co-sponsored by U.S. Sen. Benjamin L. Cardin, D-Md.,
implores the EPA to review and inspect all fly-ash holding
facilities in the nation and create new rules to regulate coal
ash.
In addition, it calls on the Tennessee Valley Authority - a
government entity responsible for a major fly-ash sludge
disaster late last year - to become the cutting edge in
technology, energy and environmentalism.
Fly-ash contamination has become a concern in the Gambrills area
after 2.4 million tons of the substance was dumped into a
sand-and-gravel mine, contaminating nearby wells with a cache of
chemicals, some hazardous.
Baltimore Gas and Electric Co. and later Constellation Energy
Group began dumping the substance in the mine in 1995. After
testing a single well in 2006, the county Health Department
found several potentially dangerous substances, including
carcinogens, and began a wide-scale investigation, revealing
contamination in at least 23 wells.
Eventually, the Maryland Department of the environment fined
Constellation $1 million and a subsequent class-action lawsuit
filed by the citizens near the sand-and-gravel mine was settled
for an estimated $54 million.
In another incident last week, about 4,000 gallons of fly-ash
sludge leaked into the Potomac River near Luke in Allegany
County.
When speaking before the Greater Crofton Council last week,
Cardin, a member of the Senate Environment and Public Works
Committee, said the fly ash has the attention of his colleagues
because of the Dec. 22 spill in Kingston, Tenn., a town around
40 miles west of Knoxville.
More than a billion pounds of ashen slurry burst from a
retention pond, covering about 300 acres with the substance,
destroying homes in the process.
While that disaster is fueling the Senate's concern over fly
ash, situations like the one in Gambrills are being discussed,
he said.
And, as members of Congress urge the EPA to create new
regulations, the MDE has created its own new series of rules for
fly-ash disposal.
The regulations require, among other things, that the bottom of
fly-ash pits be covered with a liner to prevent the substance
from leaking into groundwater, and a soil cover to prevent rain
from seeping in.
State officials also are considering new regulations for
so-called "beneficial uses" of fly ash. These uses include using
it for grading in road projects, as an additive in concrete and
in other applications.
Copyright 2009 Capital News.
Rabid
raccoon second case in Mineral County
By Jeffrey Alderton
Cumberland Times-News
Friday, March 20, 2009
KEYSER, W.Va. - A Fort Ashby man is undergoing a series of
rabies shots and his two springer spaniels are quarantined after
encountering a rabid raccoon recently.
The incident occurred March 11 on state Route 46 about three
miles from Fort Ashby when the raccoon approached the dogs that
were on a porch of the residence, according to Officer Melissa
Kidwell of the Mineral County Animal Control Office.
The occupant then shot the raccoon, which later tested positive
for rabies. The animal control office was notified Thursday of
the rabies test results.
Despite being given specific handling directions by the animal
control office, the homeowner made contact with the raccoon,
requiring him to undergo a series of five rabies vaccinations.
It was not known if the dogs made contact with the raccoon.
The dogs were current on their rabies shots but are now in a
45-day quarantine by their owner as required by law. Only two
individuals are allowed to provide care for the dogs during the
quarantine period. The dogs are also being given rabies booster
shots.
On March 10, a stray cat attacked a man on Scenic Lane in the
Lakewood area of Ridgeley.
The cat repeatedly attacked the victim as he was working in his
yard before a neighbor shot and killed the animal, which tested
positive for rabies.
The victim is also undergoing a series of rabies vaccinations as
a result of the attack.
Kidwell said citizens are reminded to keep their dogs and cats
current with rabies shots and to make sure they know where their
pets are and what they are doing.
“People need to be more responsible pet owners to protect their
pets,” said Kidwell.
A rabies shots clinic for pets will be held April 18 from 9 to
11 a.m. at Tractor Supply on U.S. Route 220 in Keyser.
“All they have to do is show up. People need to take precautions
and keep their pets up to date on their shots,” said Kidwell.
Last fall, 316 pets were given rabies shots during a clinic at
the same location.
Anyone encountering a rabid animal should not shoot it in the
head since the head is required for testing for rabies.
Handle only with gloves and dispose of the gloves after
handling. The animal should be double-bagged and kept cool until
it can be turned over to the animal control office.
For more information, contact the Mineral County Animal Control
Office at (304) 788-5720 or the county health department at
(304) 788-1321.
Rabies is a virus that can be fatal if left untreated.
Contact Jeffrey Alderton at
jlalderton@times-news.com.
Copyright © 1999-2008 cnhi, inc.
Nursing home
sold to Allegany HealthCare
By Kevin Spradlin
Cumberland Times-News
Friday, March 20, 2009
CUMBERLAND — And the winner is ... Allegany HealthCare Group
LLC.
In perhaps a surprise turn of events, acting County
Administrator David Eberly on Thursday announced the local group
as the winner of the two-horse race to purchase the Allegany
County Nursing Home and Rehabilitation Center.
The purchase price is $8 million. A three-year collective
bargaining agreement was negotiated between the new owners and
current union employees at the facility. The arrangement also
will likely secure the future of most, if not all, of the
Furnace Street facility’s non-union employees. Bill Freas, of
Rehab First, has a key role in the group currently operating or
working in the facility.
The sale was expected to go to the other finalist, North Bay
Health Associates LLC of Miami as recently as a month ago. But a
final bid submittal from the local group, which includes Bill
Freas of Rehab First, Cumberland attorney Paul Kelly, local
orthopedic surgeons Gregg Wolff and Roy Carls and Mid-Atlantic
Health Care LLC, owned by Dr. Scott Rifkin, of Baltimore. An
apparent newcomer to the group was Gilbane Development Company,
headquartered in Providence, Rhode Island.
The new management team has scheduled a news conference for 1
p.m. on Wednesday. The conference is to take place at Rehab
First, located at 157 Baltimore St. in Cumberland. Eberly said
the commissioners finalized the decision during an executive
session convened prior to the evening meeting.
Commissioner Jim Stakem said he and commissioners Dale Lewis and
Bob Hutcheson had set a deadline of March 18 to accept new
information from either candidate. Allegany HealthCare used that
time to their advantage. Initially not the highest bidder —
North Bay’s early bid was approximately $7.5 million — it was
reported last month that former House Speaker Cas Taylor had
facilitated subsequent meetings between the eventual winners and
the three-member county review team of Eberly, Jason Bennett and
County Attorney Bill Rudd.
“During the review process, the commissioners stressed the
importance of protecting the (nursing home) residents and their
families,” Eberly read from a prepared statement. “The greatest
commitment that the county can make to protect these individuals
is to ensure that a stable workforce remains in place well into
the future.”
After the meeting, Eberly said the commissioners had set the
deadline because the effort to close on the sale is a lengthy
process. He expected the sale to be finalized by June 30.
Details on the sale weren’t available. Eberly said because the
sale is not yet final, the two parties are operating under a
confidentiality agreement.
Copyright © 1999-2008 cnhi, inc.
Accused doctor's
license revoked
By Sharahn D. Boykin
Salisbury Daily Times
Friday, March 20, 2009
SALISBURY -- More than a year after charging a Salisbury doctor
with immoral and unprofessional conduct, the state medical board
permanently revoked his license, labeling the doctor's actions
as "demeaning sexual assault."
The Maryland State Board of Physicians rescinded Dr. Mahmaud
Shirazi's medical license Tuesday, citing sexual misconduct.
"Dr. Shirazi's conduct is a disgrace to the medical profession,"
said C. Irving Pinder Jr., executive director of the Maryland
State Board of Physicians in a written decision. "Dr. Shirazi's
continued practice of medicine would pose a danger to the health
and welfare of patients of this state, and the board would be
remiss in its obligations to public safety if it ever permitted
him access to patients again."
Shirazi has held a state license to practice medicine since
January 1995, according to information from the state medical
board. He was working at an internal medicine private practice,
PIM, in the 31000 block of WinterPlace Parkway in Salisbury when
the alleged incidents occurred.
Shirazi also had hospital privileges at Peninsula Regional
Medical Center, Anne Arundel Medical Center and Baltimore
Washington Medical Center, according to the board.
The board charged Shirazi last March after he reportedly
sexually violated four female patients with ungloved fingers,
according a document from the board. The suspected violations
occurred over a two-year period in a hospital and in Shirazi's
office.
In 2007, Shirazi was charged with fourth-degree sex offense and
second-degree assault, but a Wicomico County jury found him not
guilty after a three-day trial in February 2008.
He was also charged with another count of fourth-degree sex
offense and second-degree assault. Shirazi pleaded not guilty.
The state dismissed the other charges.
The decision by the board followed a a five-day hearing before
an administrative law judge who found that the allegations by
the women were true.
Shirazi denied committing unwanted sexual acts on the women;
however, the board said it agrees with the judge's determination
that the four witnesses were credible and called Shirazi's
testimony "evasive" and "dishonest."
"The board notes, as did the ALJ, that each patient's testimony
was consistent with her own previous statements, while Dr.
Shirazi's testimony as 'at times contradictory to the statements
that were made by the witnesses.' "
sboykin@dmg.gannett.com
410-845-4656
Copyright 2009 Salisbury Daily Times.
Bay's health
not getting better, EPA says
Report for 2008 finds cleanup efforts inadequate
By Timothy B. Wheeler
Baltimore Sun
Friday, March 20, 2009
The Chesapeake Bay is in poor health and didn't get any better
last year, according to the chief government program charged
with restoring it.
In an unusually frank status report, the Environmental
Protection Agency's Chesapeake Bay Program concluded that the
estuary "continues to have poor water quality, degraded habitats
and low populations of many species of fish and shellfish."
Despite some "small successes," the agency gave the bay's health
a grade of 38 percent, with 100 percent representing a fully
restored ecosystem.
The causes of the bay's troubles are well-known: overdoses of
nutrients and sediment from farms, runoff from urban and
suburban development, sewage and air pollution, the report
points out.
But the cleanup efforts made over the past 25 years by Maryland,
Pennsylvania, Virginia and the federal government are failing to
make a dent, the report concluded, and "bolder action" is
needed.
"Our progress over the past two decades is clearly not
adequate," said J. Charles Fox, the newly appointed bay adviser
to EPA Administrator Lisa P. Jackson. He pledged that the Obama
administration would provide "the leadership necessary to
improve these results."
Observers said the EPA report was more candid than previous
annual updates, which had drawn criticism for claiming cleanup
progress unsupported by water- quality monitoring.
William C. Dennison, an environmental scientist who oversees
another annual bay report card prepared by the University of
Maryland, said he thought the EPA assessment was still too rosy.
Water quality in many places isn't just unchanged, it is
worsening, he said. He said hard-to-measure pollution running
off the land appears to be overwhelming any progress made by
sewage treatment plants and factories.
"I'm not convinced we're on the right trajectory," he said.
The report cites a few bright spots. It says that the states and
federal government have already surpassed targets for preserving
land and opening streams to spawning fish. But the bay's water
quality is only 21 percent of what it needs to be, with silt and
algae clouding the water and with more harmful chemicals getting
into it. Richard Batiuk, associate director of the EPA's bay
office, said pollution would have to be reduced much more before
water quality would show any signs of improvement.
Bay grasses, which provide shelter for fish and crabs, did offer
some encouraging news - increasing by 18 percent. But even
there, officials cautioned, the overall grass growth obscured
troubling declines in the Tangier Sound, the heart of the bay's
crabbing industry.
Copyright 2009 Baltimore Sun.
Stem cell
funding, tuition freeze favored
House panel votes to protect them from budget cuts
By Julie Bykowicz
Baltimore Sun
Friday, March 20, 2009
Lawmakers took steps yesterday to preserve money for stem cell
research and a college tuition freeze pushed by Gov. Martin
O'Malley as they combed through a $14 billion proposed state
budget looking for cuts.
A House of Delegates subcommittee rejected a recommendation to
cut $13.4 million for stem cell research, choosing to commit
$18.4 million to it, as O'Malley recommended. Some have argued
that Maryland could reduce its funding after President Barack
Obama lifted a prohibition on federal spending on embryonic stem
cell research, but proponents said the state needed to maintain
its biotechnology edge.
The House panel also earmarked $16 million to maintain, for the
fourth year, a tuition freeze that O'Malley has made a priority.
On Wednesday, however, the delegates decided to cut aid to
community colleges by $35 million.
Senate President Thomas V. Mike Miller, who had expressed
reservations about continuing the tuition freeze in the face of
budget shortfalls, said Wednesday that he expects the
legislature to go along with the governor's wishes.
Another House subcommittee sliced $204 million out of the budget
over the next two years by reducing the counties' share of
highway-user revenue, which includes money generated by motor
vehicle registrations. Counties typically apply the money to
transportation projects such as repaving.
With tax revenues declining, lawmakers and the governor are
looking for more than $500 million in additional cuts for the
budget year beginning July 1.
The House subcommittee decisions made this week are subject to
change as a full committee and then each chamber considers the
spending plan.
State law requires the Assembly to pass a balanced budget by
April 6, but the deadline can be moved if agreement is not
reached by then.
Copyright 2009 Baltimore Sun.
FDA panel favors benefits of experimental J&J anticlotting drug,
despite bleeding risks
By Matthew Perrone
Baltimore Sun
Friday, March 20, 2009
COLLEGE PARK, Md. (AP) — Government health advisers said
Thursday the benefits of an experimental anticlotting drug from
Johnson & Johnson outweigh its risks, including bleeding and
incomplete data about liver side effects.
The Food and Drug Administration's panel of cardiology experts
voted 15 to 2 in favor of J&J's rivaroxaban, which if approved,
would be the first new pill-based anticlotting drug in a
half-century.
The agency is not required to follow the advice of its
panelists, though it usually does.
J&J and partner Bayer have asked the FDA to clear their
once-daily pill to stop blood clots in the legs of patients who
have undergone hip or knee replacement surgery.
More than 800,000 U.S. patients undergo the procedures each
year, and clots are a common side effect that can prove deadly
if they break loose and travel to the lungs.
In four studies of knee and hip replacement patients,
rivaroxaban cut the risk of blood clots or death in half, to 0.6
percent, compared with patients taking Sanofi-Aventis' Lovenox,
the top-selling drug currently used by orthopedic patients.
But J&J's drug also caused significantly more internal bleeding,
according to the same studies, which included over 12,000
patients.
Panelists questioned the strength of J&J's findings on blood
clot prevention, which were primarily based on medical images of
patient's veins. They also questioned the comparability of the
company's studies, which ranged in duration from less than two
weeks to five weeks.
Despite discussion points from the FDA that seemed to favor
delaying a decision on the drug, most panelists said the data
now available were enough to grant approval.
"I think we're very pleased with the discussion and outcome and
look forward to an ongoing dialogue with the agency," said Dr.
Peter DiBattiste, J&J's head of cardiology.
At the urging of regulators, panelists also scrutinized the
effects of the drug on the liver.
A similar drug from AstraZeneca was removed from the market in
2006 because of evidence it caused liver damage. While it was
never available in the U.S., because it was rejected by the FDA,
it was used by hundreds of patients in Europe.
"We should not rush into this, we should wait until we get more
data," said panelist Dr. Sidney Wolfe, a director of the
consumer advocate Public Citizen. "We haven't been able to fully
characterize the potential for severe liver dysfunction."
Despite Wolfe's urgings and a cautious tone from the FDA, a
majority of panelists said the drug did not appear to cause
liver damage in the short term.
"I think we have enough safety and efficacy data to approve it
for short term use, with the caveat that practitioners should
not prescribe it for alternate uses, particularly long-term
uses," said Dr. Peter Gross, Professor of medicine at New Jersey
Medical School.
As the first oral anticlotting drug in decades, regulators
raised concerns that doctors would begin using the drug for uses
outside the relatively narrow indication for knee and hip
replacement patients.
New Brunswick, N.J.-based J&J has touted its product as safer
and more effective than older drugs like warfarin, which has
been used since the 1950s. That drug requires patients to
undergo frequent blood tests because a too-high or too-low dose
can lead to strokes or dangerous bleeding. As a pill,
rivaroxaban would also enjoy a convenience benefit over Sanofi's
Lovenox, which must be injected.
The FDA is scheduled to make a decision on the drug by May 28.
Bayer Healthcare, a division of the German conglomerate, would
receive a royalty as high as 30 percent on U.S. sales, under an
agreement with J&J. Bayer already markets the drug in Europe
under the brand name Xarelto.
Approval for the knee and hip replacement patients will probably
not be a huge moneymaker for J&J, according to Wachovia Capital
Markets analyst Larry Biegelsen, who estimates initial sales of
about $300 million per year.
But the company is studying the drug in more than 60,000
patients for a variety of uses, including prevention of stroke.
With those approvals the drug could grow into a blockbuster
product, with sales of $1.6 billion by 2013, Biegelsen
estimated.
Shares of J&J fell 60 cents Thursday to close at $50.06.
Copyright 2009 Associated Press. All rights reserved.
National / International
Economy May Test Census
By Steve Vogel
Washington Post
Friday, March 20, 2009; A17
The faltering U.S. economy is causing concern about the ability
of the 2010 census to get a full and accurate count of the U.S.
population, according to Census Bureau officials and experts.
The increase in home foreclosures and the rising jobless rate
mean more Americans are moving out of their homes and into
shelters or other locations where they may be harder for census
workers to find.
"The economy really has all kinds of implications for the
census," said Frank A. Vitrano, a division chief at the bureau
who oversees planning and coordination for the 2010 count.
"Every day we're learning new things."
As an example, Vitrano cited reports about growing numbers of
people living in cars or in tent cities in California and other
places.
"We've got to build that into our operations," Vitrano said,
speaking Wednesday at a Brookings Institution forum on the 2010
census.
The issue is of particular concern to Hispanic advocacy groups,
which are pushing for an end to undercounts of the Latino and
other minority populations.
Arturo Vargas, executive director of the National Association of
Latino Elected and Appointed Officials, expressed concern at the
forum that the bureau's plans for conducting the 2010 census do
not take into account the depth of the current recession and the
resulting displacement of minority families hit hard by job
losses and foreclosures.
Little more than a year remains until the constitutionally
mandated decennial head count. Earlier this month, the
Government Accountability Office reported to Congress that the
accuracy of the 2010 census remains threatened by computer
problems and untested methods that the Census Bureau plans to
use for conducting the count.
Robert Goldenkoff, director of strategic issues for the GAO,
noted at the Brookings forum that it will cost the Census Bureau
about $100 to count each housing unit in 2010, compared with
$14, adjusted for inflation, in 1970.
Terri Ann Lowenthal, a consultant for several 2010 census
projects, noted that in neighborhoods where as many as one in
five homes might be vacant, the Census Bureau may have to spend
a great deal of time and money to determine which units are
occupied and which have been abandoned.
Lowenthal also expressed concern that financial hardships may
make some Americans less likely to cooperate with census
workers. "Families are afraid to open the door, because they're
not sure if the next knock is the repo man," she said.
One bright side for the Census Bureau amid the bad economic
news: The bureau is not having any problem finding temporary
workers to help with the 2010 count.
The bureau received more than 1 million applications for the
140,000 available temporary staff positions to perform address
canvassing this year, according to bureau spokesman Stephen
Buckner.
"With the economy, we're having great success with recruiting,"
Vitrano said.
Copyright 2009 Washington Post.
Nestlé's Inspectors Saw Rat Droppings, Rejected Peanuts
Hearing Explores Why Others Did Not
By Lyndsey Layton
Washington Post
Friday, March 20, 2009; A02
Nestlé USA, considering whether to buy ingredients from Peanut
Corporation of America, twice sent its own inspectors to check
out the company. Both times, they rejected the company after
finding sanitary problems at its facilities in Georgia and
Texas, noting rat droppings, live beetles, dead insects and the
potential for microbial contamination.
It proved to be a good call.
Today, Peanut Corporation of America stands accused by federal
investigators of knowingly selling peanut products contaminated
with salmonella bacteria, which triggered a criminal
investigation, the largest food recall in American history and
an outbreak of illness that has sickened at least 691 people and
killed nine since September.
Kellogg and other companies that bought products from Peanut
Corporation of America told lawmakers yesterday that unlike
Nestlé, they did not perform their own inspections. Instead,
they relied on third-party audits common in the U.S. food
industry.
David Mackay, Kellogg's chief executive, said his company
trusted audits performed by the American Institute of Baking
International, the biggest food-inspection firm in the country.
The institute conducted scheduled inspections of PCA's
facilities and never flagged serious problems. It issued a
"certificate of achievement" and a "superior" rating last
August, when PCA was getting results from internal laboratory
tests that revealed a salmonella problem in its plant in
Blakely, Ga., congressional investigators said.
"They gave PCA glowing reviews," said Rep. Henry A. Waxman (D-Calif.),
chairman of the House Energy and Commerce Committee. "The
company was selected by PCA, paid by PCA, and realized that if
they didn't give PCA a glowing review, they were not going to
get hired again.
"They gave PCA a certificate of achievement," added Waxman, who
held up the certificate in one hand and with the other waved a
photograph, taken by federal investigators, of dead rodents
inside a PCA facility. "How do you have a company that looks
like this getting a certificate of achievement? . . . It really
makes you think there must be something wrong."
E-mails released by the committee showed a comfortable
relationship between the auditor for AIB and PCA's plant
manager. In one e-mail, the auditor tells the plant manager to
get the plant ready for inspection, asks the manager to select
the date and then offers holiday wishes to the manager and his
family.
Brian Soddy, vice president of marketing and sales for AIB,
defended the audits in a telephone interview yesterday and said
that PCA "went to great lengths to clean it up" before scheduled
inspections. Others, including Georgia state inspectors, had
also missed problems in PCA's facilities, he said.
AIB conducted basic annual audits at a cost of about $1,000 for
PCA. It offers more rigorous inspection services, including a
multi-year program at a cost of $20,000 to $30,000, but that was
not part of its contract with the peanut company, Soddy said.
Rep. Bart Stupak (D-Mich.), chairman of the panel's oversight
and investigations subcommittee, asked why Kellogg and other
companies did not investigate their suppliers.
"Nestlé didn't solely rely on an auditor selected by PCA and
paid by PCA," he said. "It conducts its own audit with its own
staff. You all talk about how safety is the number one issue.
Why didn't you do the same thing?"
Kellogg, which has lost about $70 million because of the recall,
is now sending its own inspectors into peanut-processing plants
and is no longer relying on third-party firms paid by the
processors, Mackay said. He said that Kellogg follows that
procedure for other raw materials and foods that carry high
risks for contamination, but that it is impossible for Kellogg
to inspect each of its 1,000 suppliers. And although food
companies bear some responsibility to ensure their supplies are
safe, they are powerless against a dishonest supplier, he told
lawmakers.
"On every batch, we received a certificate of analysis from PCA,
and every batch [was] negative" for salmonella, he said. "It's
extremely difficult when you have an unethical and dishonest
supplier to manage this."
Starting in 2007, Kellogg purchased $5 million to $10 million
worth of peanut ingredients annually from PCA and used them in
its Keebler cookies and crackers, Famous Amos cookies and Austin
peanut butter crackers, among other items, Mackay said.
Yesterday's hearing was the third held by the committee into the
scandal surrounding PCA, which filed for bankruptcy protection
last month. The case has called national attention to food
safety and has sparked dozens of proposals for reform on Capitol
Hill. President Obama, who has expressed concern about the
peanut butter sandwiches consumed by his 7-year-old daughter,
has flagged food safety as a priority. His proposed budget
includes additional money for food inspectors at the Food and
Drug Administration, and he has created a White House working
group to recommend ways to increase food safety.
The outbreak of salmonella illness is ongoing, although
officials at the Centers for Disease Control and Prevention say
the number of new cases has declined substantially. They said
they expect new illnesses to be reported for the next several
months, because some recalled items have a long shelf life and
remain in home pantries and in some stores. The FDA does not
require retailers to prove that recalled food has been destroyed
and has no way to know how many of the more than 2,000 recalled
products are still in circulation.
Consumers can check the searchable database for recalled
products at http://www.fda.gov.
Copyright 2009 Washington Post.
Raw Milk Is Gaining Fans, but the Science Says It's Dangerous
Dairy farm owners report growing interest in buying shares in
their cows
By Kerry Hannon
US News and World Report
Friday, March 20, 2009
Kitty Hockman-Nicholas's phone is ringing off the hook. Callers
to her dairy farm in Winchester, Va., are so eager to buy a
share in one of her 20 hormone-free, grass-fed Jersey cows that
she expects her 150 cow co-owners to double in number this year.
Why buy a cow? For the unpasteurized raw milk. A growing number
of consumers are keen to drink raw milk, for reasons ranging
from a desire to buy locally produced food to taste to a belief
in its purported health benefits. Word of mouth abounds of how
raw milk cleared up asthma and ear infections in children,
improved osteoporosis in seniors, and even made autistic kids
function better. (Pasteurization-subjecting milk to a short
burst of heat to kill bacteria, followed by rapid cooling-has
been standard protocol since the 1920s in this country.) Sally
Fallon, founding president of the Weston A. Price Foundation, a
Washington, D.C.-based advocate for consumption of whole,
natural foods
, estimates that more than 500,000 consumers regularly consume
raw milk and claims that the number "is growing exponentially."
Accurate sales estimates are hard to come by, though, since the
government is firmly opposed to raw milk and in many states-like
Virginia-the only way to get some legally is to tap right into
the cow. (U.S. News interviewed farmers at more than a dozen
dairies from Virginia to California, and all reported a
significant bump in sales of raw milk or in dairy cow ownership
in the past few years.) Scientists warn that no evidence exists
to back up most of the reported health benefits of raw milk and
that there are serious risks of infection from listeria,
salmonella, and E. coli. From 1998 to May 2005, raw milk or
raw-milk products have been implicated in 45 foodborne illness
outbreaks in the United States, accounting for more than 1,000
cases of illness, according to the Centers for Disease Control
and Prevention. And that's probably an understatement, the
report notes, since foodborne illnesses often go unrecognized
and unreported.
"It's like playing Russian roulette with your health," says John
Sheehan, director of the Food and Drug Adminstration's Division
of Dairy and Egg Safety. The dangers, he says, range from mild
food poisoning to life-threatening illness. "One complication
that can arise as a result of infection with E. coli O157:H7 is
hemolytic uremic syndrome, which can cause acute renal failure,
especially in the very young or the elderly," Sheehan says.
"There are absolutely no health benefits from consuming raw
milk."
Indeed, it's only in the case of asthma and allergy that some
evidence exists to suggest a possible protective effect. A study
published in the June 2006 issue of the Journal of Allergy and
Clinical Immunology by researchers at the University of London
analyzed the diet of 4,767 children in Shropshire, England, and
found that those who lived on farms and drank raw milk had
significantly fewer symptoms of asthma, hay fever, and eczema.
Children who drank raw milk were 40 percent less likely to
develop eczema and 10 percent less likely to get hay fever than
their peers who didn't drink raw milk. A second European study
of nearly 15,000 children published in the May 2007 issue of
Clinical and Experimental Allergy found that children who drank
raw milk were less likely to have asthma and hay fever. Still,
both reports warned that raw milk often harbors pathogens, and
neither recommended consumption of raw milk as a preventative
measure.
While there are no laws against drinking raw milk straight from
the source, the government banned interstate sales more than two
decades ago, leaving states to decide what to do when consumers
within their borders want to buy raw milk. Twenty-three states
ban the sale of raw milk for human consumption; the rest allow
the purchase under certain conditions. In Maryland, a farmer who
is caught selling raw milk runs the risk of jail. In California,
raw dairy products are sold in some grocery stores. In Illinois,
consumers can buy straight from the farm if they bring their own
containers. In Virginia, it's legal to drink raw milk only from
a cow that you own.
Raw-milk advocates like Fallon, who swears by raw milk for her
own family, contend that pasteurization greatly reduces vitamin
C and affects B6 and B-12 and beneficial bacteria such as
lactobacillus. Sheehan does not argue with the fact that
pasteurization destroys some vitamins and enzymes, but he calls
the losses insignificant.
One possible alternative for aficionados of the local and
natural: Drink very fresh milk from a well-run local dairy that
doesn't practice homogenization (a process that breaks up and
blends in the fat molecules to prevent cream from rising to the
top) and uses a pasteurization process done at a relatively low
temperature for a long time. "This method eliminates harmful
bacteria with minimal impairment of flavor," says Anne Mendelson,
a culinary historian and author of Milk: The Surprising Story of
Milk Through the Ages.
Hockman-Nicholas, 67, has been drinking raw milk her entire life
and says she has never been sick from it. Nor, she says, has she
had a complaint from any of her customers, who pay about $80 up
front and $28 per month for a cow share that produces 1 gallon
of raw milk per week. Because she runs a grade A dairy, the top
level for dairy farmers, the milk is tested frequently for
quality by the state, and the facility is inspected regularly by
the Virginia Department of Agriculture for the sanitation of the
equipment and surroundings. The farm is also USDA-inspected.
Hockman-Nicholas's cows are routinely tested for tuberculosis
and brucellosis (they've never come up positive, she says). And
bacteria levels in the milk are monitored.
But microbiologist Kathryn Boor, chair of the food science
department at Cornell University, calls raw milk "a dangerous
choice." Boor grew up on a dairy farm, drank raw milk as a
child, and is willing to grant it some of the credit for her
robust health. "Although my family is still in the dairy
business, there is not a single person who still drinks" raw
milk, she says. "There have been no conclusive studies to show
the health benefits. And the risks of exposure to harmful
bacteria very clearly can cause illness to death."
Copyright 2009 US News and World Report.
Opinion
False
teeth
Our view: Maryland can put teeth into efforts to fight false
Medicaid claims by giving state investigators the power to seek
larger fraud damage awards
Baltimore Sun Editorial
Friday, March 20, 2009
With the state facing a potential $1 billion-plus budget deficit
and money getting tighter every day, one might think that
collecting an extra $11 million from health care providers who
defraud the Medicaid program wouldn't be terribly controversial.
But Gov. Martin O'Malley's proposal to do just that has met
surprising resistance in Annapolis this year.
The Senate has a chance to set matters straight this morning,
however, by approving the governor's proposal to allow the state
to collect up to triple damages in Medicaid fraud cases. The
federal government already has such authority - as do at least
22 other states - but the measure is opposed by drug companies
and some misguided souls in the medical community who argue it
will increase health care costs.
In this, opponents are 100 percent wrong. Studies have suggested
that 10 percent of the nation's health care dollars end up
paying for waste, fraud and abuse. Any effort to discourage such
behavior ought to be applauded by the health care community, not
feared.
The Maryland False Health Claims Act is a response to the grim
reality that the federal government has a roughly 10-year
backlog of Medicaid and Medicare fraud cases. The Maryland
attorney general's office is an active prosecutor in this arena,
but the state lacks the authority to penalize perpetrators
beyond the amount stolen.
Annually, the state collects more than $20 million from such
fraud, but states that have the authority to seek triple damages
do much better. When Tennessee changed its law, collections went
from $3.5 million to $19.7 million. In Texas, the amount rose
from $25.3 million to $136.6 million. The federal government
actively encourages such efforts - states that adopt these
measures are given a bigger share of the state-federal split of
any false claim.
Remember, these scofflaws aren't physicians who made some
innocent clerical error but people who have deliberately bilked
the government. By failing to impose a penalty, Maryland
essentially gives interest-free loans to frauds. The fact that
the perpetrators include large and politically connected drug
companies such as Merck (which recently agreed to pay a $670
million government claim) ought not discourage the effort.
Copyright 2009 Baltimore Sun.
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