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From USA Today
FDA issues new rules vs.
mad cow disease Materials banned from human use
Six months after the discovery of the
first U.S. case of mad cow disease, the Food and Drug
Administration issued long-delayed rules Friday banning
nervous system tissue and other cattle parts from use in
human food, dietary supplements and cosmetics.
The ban prohibits the use of the brain,
skull, eyes and spinal cord tissue -- where infectious
agents of the brain-wasting disease first appear -- from
animals 30 months and older. Banned from all cattle are
tonsils and small intestines and material from cattle
that cannot stand up on their own.
Manufacturers and processors must
immediately cease using any of those materials.
The agency also is seeking public and
industry comment on a proposed ban on the use of the
materials in animal feed.
The rules bring the FDA in line with
those issued by the U.S. Department of Agriculture just
weeks after the discovery in December of a diseased cow
in Washington state. The FDA ensures that food for
humans as well as animals is pure, wholesome and does
not contain unsafe additives.
But the agency might not finalize all
its animal feed rules until 2006, says Stephen Sundlof,
director of the FDA's Center for Veterinary Medicine,
and that has food safety advocates up in arms.
Jean Halloran of Consumers Union said
while the FDA mulls its options, ''this dangerous
material is still being fed to the cows.''
The FDA strengthened feed rules in 1997
and proposed new rules banning the feeding of
potentially infectious material to cattle in November
2002. The proposals included bans on feeding cattle
restaurant leftovers, poultry litter and dried cattle
blood.
Mad cow disease, known to scientists as
bovine spongiform encephalopathy, is spread when the
infected animals are recycled into feed. People who eat
infected meat risk contracting a rare but fatal human
condition, variant Creutzfeldt-Jakob disease.
''The Bush administration has reneged on
its pledge to take additional steps to protect human and
animal health from BSE,'' says Carol Tucker Foreman of
the Consumer Federation of America.
But Sundlof says the broader feed rule
on which the FDA is seeking comment may supercede the
prohibitions it proposed earlier. By removing specified
risk materials (brain, skull, eyes, spinal cord, small
intestine, tonsils), ''you take about 90% of all the
infectivity out of the system altogether,'' he says.
The FDA hopes to have the new feed rules
in place within eight months, Sundloff says. ''Focusing
our attention on the highest-risk materials and
eliminating those from the animal feed supply will take
us very far, and then we can sort through the rest.''
Study: Not all kids with
glasses need them Many will outgrow mild farsightedness
A study released today finds that up to
25% of children with normal eyes who have comprehensive
vision exams may be prescribed glasses they don't need.
In an article published online in the
Journal of the American Association of Pediatric
Ophthalmology and Strabismus, researchers examined the
records of more than 100,000 preschoolers who were
screened through a statewide program in Tennessee.
More than 3,600 children were referred
to specialists for follow-ups because of suspected
disorders, such as lazy eye, according to the study.
About one-quarter, or 890, were found to have no eye
problems. Yet nearly one in five of these children were
prescribed glasses.
Some health professionals were more
likely to misdiagnose kids than others, says Sean
Donahue, lead study author and an associate professor of
ophthalmology, pediatrics and neurology at Vanderbilt
University School of Medicine. Optometrists prescribed
glasses 35% of the time; general ophthalmologists, 12%;
and pediatric ophthalmologists, 2%, the study shows.
To Donahue, that suggests optometrists
and ophthalmologists who usually treat adults may not
have as much expertise with children. Many youngsters
are slightly farsighted, he says, although most will
grow out of the condition without glasses.
Though many doctors recommend that
preschoolers should be screened for vision problems,
experts disagree about the best approach. Kentucky
requires that youngsters undergo comprehensive eye exams
before beginning school.
Donahue says states should carefully
examine such expenses before following Kentucky's
example. Given the high level of misdiagnoses, Donahue
says, such laws could be expensive. Glasses cost about
$150; exams add another $100.
Instead of forcing all preschoolers to
get a formal exam, he says, kids could be screened by
doctors, teachers, nurses or others, then referred to
eye specialists for further examination.
Susan Taub, an assistant professor of
ophthalmology at Northwestern University, says she is
concerned that many children have undiagnosed eye
disorders, which can cause permanent damage or hurt
their ability to learn.
Doctors still do not know which tests or
technology work best, Taub says. ''This does need
further study. We don't want kids to fall through the
cracks.''
Toxic attack on cows points
to reporting problems Time lag called disturbing in
light of Sept. 11 and food supply concerns
An attack in which Washington state cows
were coated with a toxic substance went unreported to
federal officials for 10 days, a performance that local
and national officials say is unacceptable when there
are concerns about the safety of the nation's food
supply.
The incident involved 10 dairy cows in
Enumclaw, 35 miles southeast of Seattle. The animals
were painted June 5 with a sticky red substance that
caused welts, oozing sores and internal bleeding.
Three of the cows died; seven are
recovering. Food and Drug Administration testing later
identified the substance as chromium, used in dyes and
as a wood preservative. No milk from the cows entered
the food supply, the FDA said Wednesday.
It is unknown who attacked the cows.
Initial news reports said it was related to a labor
dispute. But whatever the motivation, officials say the
incident represents a failure to take potential
agriculture contamination seriously, particularly in the
wake of the Sept. 11 terrorist attacks.
''If this were a first test case, the
system failed,'' says a senior federal government
official familiar with the incident. ''If there were to
be a real event, God help us all, because this just
demonstrates how little has really been done'' to make
local officials aware of potential problems.
Farmer John Koopman discovered that his
animals were ailing the morning of June 6, and
immediately called his veterinarian and the King County
Sheriff's office. It took the sheriff's department
''two, three, four days'' to contact the state
Agriculture Department, says Sgt. John Urquhart of the
sheriff's office. It then took another week, until June
16, for someone to tell Ken Parrish, the state
Agriculture Department's liaison to the U.S. Department
of Homeland Security. He then followed emergency
procedures, setting in motion the chain of events that
brought in Homeland Security, FDA and the U.S.
Department of Agriculture.
What took place over 10 days should have
happened soon after the farmer discovered the sick cows,
according to officials. The incident is under
investigation by the federal agencies involved.
''Any time something like that happens,
we want to find out about things as soon as possible,''
says Robert Brackett, FDA's director of food safety.
''People want to make sure that they're not giving a
false alarm and causing disruption when it's not needed.
But now with the increased awareness, everybody has a
role to play in securing the country,'' he says.
''Since Sept. 11, we just have to start
thinking about things in a new way. And we're not very
good at it yet,'' says Kate Sandboe of the state
Agriculture Department. ''Our minds don't run to
(potential bioterrorism) immediately.''
There has been no cohesive
homeland-security plan involving agriculture and funding
has been haphazard, resulting in ''lots of little pieces
in place,'' says Orlo Ehart of the National Association
of State Departments of Agriculture in Washington, D.C.
Before the Sept. 11 attacks, federal
authorities likely wouldn't have been involved until the
toxic substance was identified, says Ehart. ''Washington
state is a long way from the East Coast. And while you
may think you're doing your job, you may not be in tune
with the new issues,'' he says.
Officials say the incident is
particularly disturbing because Washington state has
been ground zero for other food safety issues in the
past 10 years, including the E. coli outbreak in 1993
and last year's discovery of the nation's first case of
mad cow disease.
''The food system is complex, and it
takes a complex response to make sure that these delays
don't happen,'' says Steve Cain, homeland security
project director for the Extension Disaster Education
Network, a national group of agricultural extension
workers.
TRAVEL Cruise-ship stomach
virus picking up steam again
Remember all the hubbub over stomach
illness on cruise ships? It's back.
Industry newsletter Cruise Week reports
that 1,355 cases of norovirus-like illness occurred on
12 ships during the first five months of the year.
That's almost double the 700 cases recorded on seven
ships during the same period a year ago.
The latest outbreak occurred last week
when 66 passengers on an Alaskan cruise aboard the
Island Princess came down with the illness. It followed
a wider breakout on the ship the week before that
affected 425 -- the industry's largest recorded incident
since 1994. Other ships reporting outbreaks this year
include the Norwegian Crown, Holland America's Veendam
and Ryndam, Celebrity's Zenith and Horizon, Cunard's
Queen Mary 2, Carnival's Celebration and Royal
Caribbean's Brilliance of the Seas.
Outbreaks made headlines in late 2002
when the disease ran through seven ships, causing 1,340
reported cases. The U.S. Centers for Disease Control,
which tracks outbreaks on cruise ships, says the illness
is common nationwide during the winter.
05/18/2004
Autism's surge mystifies
Broader definition of disorder fails to explain dramatic
rise in number of children afflicted
Autism, once a rare and
mysterious disorder, is no longer so rare. A generation
ago, only two to four of every 10,000 children were
labeled autistic. Today, it's more like 60 per 10,000 by
some estimates.
But no one knows why.
Experts cite a much greater awareness of autism and
related conditions, grouped as Autism Spectrum Disorders
(ASD), and a broader definition that has allowed
children who might otherwise have been overlooked to
receive a diagnosis. But they also say there has been an
actual increase, and the reasons for that are not
entirely clear -- though there are plenty of theories.
ASD, usually noticed by the
time a child is 3, is four times more common in boys
than girls. It affects social interaction, communication
and behavior, but there is wide variety in symptoms.
Some children don't speak. Some are talkative, but don't
make eye contact. Some are clingy, while others hate
being held.
''Years ago autism was a
very rare diagnosis,'' says embryologist Patricia Rodier
of the University of Rochester Medical Center, partly
because there was no impetus for doctors to label a
child as autistic. ''It did not qualify you for special
education. No one in good conscience could give that
diagnosis, because you couldn't get special education.''
That has changed. The
number of children identified by schools as having ASD
has risen by nearly 18% since the early 1990s.
Susie Kelly of Laurel,
Del., says she and her husband, Tom, suspected very
early that their second child, Mark, now 9, was not like
other toddlers. The first clue was his reaction to
surprises.
''If someone came into the
house he would cry, or when he was visiting his
grandmother, if his aunt came in, he'd have a fit
because that wasn't what his expectation was,'' she
says.
She was certain something
was wrong one day when she stopped off to buy doughnuts
as she was driving him to day care. ''It blew his mind
because I took a different route.''
Mark was finally diagnosed
at age 3, and to the Kellys, ''it was almost a relief,
because we had a name for it.'' Almost.
''It was devastating,'' she
says, choking up. ''And I didn't even know what it meant
then. It was continuous grieving.''
The Kellys moved from
Maryland to Delaware, where a comprehensive program of
care is available for Mark through age 20.
The rising incidence of
autism and effective lobbying by parent groups have sped
the pace of research into causes and treatments for
developmental disorders.
The National Institutes of
Health has allocated $65 million in funding for a
network of eight ''centers of excellence,'' where top
researchers are narrowing in on genes that may play a
role and are working to understand what causes them to
go awry.
A mysterious disability
Evidence of a genetic basis
for autism is strong. If one of a pair of identical
twins is autistic, 90% of the time the other is too,
says Eric Hollander of the Seaver Center for Autism
Research and Treatment at Mount Sinai School of
Medicine. Researchers have found genetic mutations
linked to autism, and most believe several such
mutations must occur before autism results. In an April
report in the American Journal of Psychiatry,
Mount Sinai researchers reported the discovery of a gene
that doubles the odds of autism in those who carry it,
or one of its variants.
''We know there are genetic
factors,'' Hollander says, but something else may also
be involved. ''It is possible there are environmental
factors'' that trigger the genes.
Several possibilities have
been investigated, from junk-food diets, which are high
in fatty acids that could interfere with the coating of
nerve cells in the brain, to a drug used to induce labor
in pregnant women. But no environmental link has been
found.
Embryologist Patricia
Rodier of the University of Rochester Medical Center and
her colleagues say whatever happens to the developing
brain may occur very early in pregnancy. ''We're
fascinated by the fact that symptoms of autism appear in
a number of congenital conditions that we know arise a
few weeks after conception,'' she says. In addition,
maternal exposure to some substances known to cause
birth defects, such as the German measles virus and
alcohol, also increases the risk of autism.
Another area of interest is
the possible link between autism and immune-system
disorders.
An immune-system link is
supported by some doctors and parents of children with
autism who believe that a mercury-based preservative
that has been used in childhood vaccines is at the core
of the problem.
Thimerosal is being phased
out of most vaccines for children, but some lots that
contain the preservative are thought to be on doctor's
shelves. Some studies have suggested that children with
autism are less able than others to expel mercury from
their systems, and some parent groups think multiple
vaccines given to young children weaken the immune
system and allow a build-up of mercury in developing
brains.
Other scientists say this
theory has been thoroughly investigated, but no
conclusive evidence has been found. They say a continued
focus by activists on thimerosal may undermine
confidence in vaccines and divert funding from more
promising theories. The Institute of Medicine, which
provides advice on science and health to government, is
expected to release a report today that conclusively
dismisses the theory of thimerosal as a cause of autism.
'False hopes' for an affected child
Today, Mark Kelly is an
affectionate, talkative boy. He loves his sister Laura,
10, and likes to play, though he doesn't play with other
children, his mother says. He's in a special school for
autistic children.
Progress is being made and
there is more information available to parents than
there was even five years ago, Susie Kelly says.
''We had false hopes he'd
be cured,'' she says. ''That didn't happen. He's clearly
autistic. He's able to talk about what he needs or wants
to do, but he can't really hold conversations. . . .
Now we're looking toward a future where I don't
think he'll be able to live on his own. I don't think
he'll ever have a driver's license or a
girlfriend.''
04/15/2004
Cattle feed rules unchanged
New regulations tied up in red tape
Early
this year the U.S. Food and Drug Administration, fearing
the spread of mad cow disease, made a highly publicized
announcement of major changes to materials that can be
fed to cattle.
But almost three months
later, the rules have yet to be changed, and potentially
dangerous materials can still legally be fed to cows.
The agency has yet to write
or publish new rules. ''We're still working on it,'' FDA
spokesman Brad Stone says. ''We don't have a set time
frame. We hope it will come up very soon.''
Cattle can get the
brain-wasting disease only by eating food that contains
protein from infected bovines. People who eat infected
materials can contract a human version that also is
deadly.
Industry critics and
scientists applauded when the FDA announced on Jan. 26
that it was going to get rid of three loopholes in the
feed ban it enacted in 1997 to protect the U.S. cattle
supply from bovine spongiform encephalopathy.
One was the practice of
feeding poultry litter to cattle, because poultry feed
can include cattle remains. Another was feeding them
restaurant-plate waste, which might contain beef. And
another was giving feed and formula made from the blood
of ruminants (cattle, sheep and goats) to cattle and
calves.
Stone says that although
the rules don't go into effect until they're published
in the Federal Register, ''the purpose of our
announcement was to give a strong indication of the fact
that this is a practice on its way out. We anticipate
that that's a message that was received by the
industry.''
Not so, says Rex Runyan of
the American Feed Industry Association. ''It's business
as usual until they publish those rules. I don't know of
any companies that have made any major changes based on
rumors or speculation.''
''There's significant work
being done on these FDA regulations . . . at the
White House level,'' says Caroline Smith DeWaal of the
Center for Science in the Public Interest. ''The Bush
administration is catering to industry concerns.''
Smith DeWaal notes that the
USDA implemented its own preventive measures --
including keeping disabled cows out of the food supply
-- eight days after the discovery of the first U.S. case
of mad cow. ''FDA isn't writing a regulation out of
whole cloth here; they're merely strengthening and
amending an existing one.''
04/12/2004
Help 'happy pill' patients
separate hype and science
Is the honeymoon for
''happy pills'' finally over?
The recent warning from the Food and
Drug Administration (FDA) that physicians need to
closely monitor patients for suicide risk when first
prescribing certain antidepressants sent shock waves
through the 34 million Americans who suffer from
depression. It also shook up the pharmaceutical giants
that manufacture the drugs.
Ten drugs may be linked, the FDA says,
to an increased suicide risk. Six of the drugs belong to
a genre known as SSRIs, which are believed to |