NIH to pay $500 million yearly to turn research into practical remedies
By Jonathan D. Rockoff
Baltimore Sun
reporter
Thursday, October 13, 2005
WASHINGTON // The National Institutes of Health unveiled yesterday a
$500-million-a-year program to turn promising laboratory discoveries in
genetics and other fields into drugs and treatments.
The new program announced by NIH Director Elias A. Zerhouni is intended to
address a lack of funding that many researchers say has left them unable to
take recent scientific advances to the next stage and translate them into
practical uses for patients.
Yesterday, researchers applauded the program, which will pay select
universities and private institutions to establish departments dedicated to
such follow-up work.
"What this is going to do is facilitate the knowledge transfer from the lab
to clinical research. It's going to make clinical research easier to do,"
said Michael J. Klag, dean of the Johns Hopkins Bloomberg School of Public
Health.
Although pharmaceutical and medical companies support much clinical
research, they tend to pursue new drugs and devices with the most profit
potential, leaving many possible treatments to universities and research
institutions to develop.
For years, universities performed most of the country's applied science,
relying on profits from treating patients at their hospitals to pay for it.
But as health insurance companies have cut payments, the money for research
has dwindled.
So has the number of young doctors and scientists entering the field. The
lack of funding and the time-consuming nature of the research make it harder
for them to write the papers needed to ascend the tenure track.
The NIH initiative seeks to unclog the bottleneck by giving universities and
researchers a financial incentive to do the work, NIH officials said.
It will fund university departments, centers or institutes where researchers
can study effective therapies and learn the increasingly complex skills
behind this type of clinical work. The program also will support efforts to
ease the regulatory approvals needed to conduct tests on patients, and it
will pay for developing novel ways to perform the research.
"It's one of the biggest changes to happen in clinical research in many,
many years," said Mendel Tuchman, vice chairman for research at the
Children's Research Institute, in Washington, D.C.
There are plenty of scientific advances awaiting translation into effective
treatments, researchers say. Just in the past few years, study of molecular
abnormalities that cause cancers has produced several potential new
therapies.
At the University of Maryland, a researcher believes that drugs that have
proven effective at treating breast cancer might be helpful for treating
prostate cancer as well, said Kevin J. Cullen, who directs its cancer
research center.
Faster answers
"But we can't test them as fast as these new drugs are being developed. We
don't have enough clinical scientists," Cullen said. He expressed hope that
the NIH program would make it possible to "answer the questions years faster
than we do now."
"This may not completely solve the problem, but if it provides a pool of
younger scientists to do this kind of work, then that will have been an
enormous accomplishment," Cullen said.
The program is the latest in Zerhouni's efforts to reorganize NIH priorities
as research suggests common sources for the underpinnings for various
diseases and a need to break down the disciplinary walls that have existed
between specialists who study them.
It makes more sense, Zerhouni says, for scientists who study different
diseases and organs to work together with mathematicians, engineers and
others who can help with clinical research.
With a $28 billion budget, the agency is the federal government's main
source of funds for medical research. It now pays for several separate
clinical programs, including 78 research centers and various training
programs.
Zerhouni described the new initiative as an effort to consolidate the
existing programs - and their funding - while quickening the application of
basic research.
"It is designed to spur the transformation of the clinical research
enterprise," he said.
Next year, NIH expects to award $30 million for several new clinical
research centers, said Barbara M. Alving, the agency's acting director of
the National Center for Research Resources. It plans to grant an additional
$11.5 million to underwrite 50 applications to open centers. By 2012, it
plans to award $500 million to 60 centers.
Among those most anxious about the announcement were administrators of
existing NIH-funded clinical research programs, who fear they could lose
their current funding. They will have to apply for the new awards.
Tuchman, who operates one of the current programs, said he would develop a
partnership between his institute and affiliate George Washington University
so young doctors could earn degrees in clinical research.
Tuchman praised the new initiative for bringing lab scientists together with
doctors and nurses working with patients. He also praised Zerhouni for
giving the research institutions more authority over how they use their
funding.
"It's all going to come down to future funding - whether they will be able
to sustain it," Tuchman said.
'A
new paradigm'
This is the second attempt at the program. Last year, a somewhat similar
effort was announced. But after researchers spent months writing grant
applications, NIH shelved the plan, saying it wasn't ambitious enough.
Even without federal support, a few universities recently have embarked on
their own efforts to better link basic and applied research. Last year, the
Cleveland Clinic Foundation established a medical school to train doctors in
the work.
It is a likely model for what NIH is promoting. Richard A. Rudick, chairman
of the division of clinical research, said students learn biostatistics,
bioethics and epidemiology and other research skills from their first summer
on.
"There is a whole range of clinical research that needs to be done that
isn't well accomplished at the moment," he said. "That's why there's a
feeling we need a new paradigm."
Mayor notes medical community in Baltimore, job opportunities
By John Fritze
Baltimore Sun
reporter
Thursday, October 13, 2005
Arguing that the city's vast medical assets could be harnessed to reduce the
nation's vulnerability to a flu epidemic, Mayor Martin O'Malley asked
government leaders yesterday to consider building a vaccine production
center in Baltimore.
O'Malley said his administration intends to spend several hundred thousand
dollars to explore whether developing vaccines in Baltimore - a move that
would almost certainly require federal funding - would create jobs and
significantly speed up sluggish vaccine production.
"Imagine the opportunity that this presents for our state and for our city,"
O'Malley said. "Baltimore and Maryland are better positioned, I would argue,
than any other state in the union to be able to become the center of vaccine
production."
O'Malley's proposal comes as scientists and elected officials worldwide are
beginning to wrestle with the possibility of a pandemic of the deadly avian
flu, which some fear could kill millions of people. The need for vaccine, in
that scenario, could quickly overtake the capacity to produce it.
In a letter sent to state economic officials yesterday, O'Malley vowed to
fund half the cost of a feasibility study to determine whether the
manufacturing of vaccine in Baltimore is a worthwhile idea. The study could
cost $100,000 to $400,000, depending on its scope.
Aris Melissaratos, secretary of the state Department of Business and
Economic Development, said he expects his agency will cover the remaining
cost of the study. Melissaratos said he believes an inquiry is justified,
but he also said the investigation should not be limited to Baltimore.
"Maryland has the potential to become the vaccine production capital of the
world," Melissaratos said. "It is an opportunity that we need to pursue."
Regardless of its location, the creation of a vaccine production plant would
face huge technical and regulatory obstacles, several experts said. For
instance, scientists need millions of fertilized eggs - chicken eggs,
usually - to produce vaccines, a requirement that can complicate inner-city
production.
Ultimately, the city would hope to tap federal money to build a facility, if
it was deemed practical. O'Malley pointed to a $3.9 billion allocation
approved by the Senate last month to expand vaccine production and research
within the United States. Much of that money, however, has been earmarked to
increase stockpiles of antiviral medications.
Public health experts are paying close attention to the bird flu, which is
circulating in Southeast Asia. The virus mostly has been transmitted from
birds to humans. Efficient human-to-human transmission could quickly spread
the virus around the world, said Dr. Alfred Sommer, a former dean of the
Johns Hopkins Bloomberg School of Public Health.
"There are alarming trends, and that's what's getting people's attention,"
said Sommer, who agreed to lead an advisory group on O'Malley's initiative.
"The way we presently manufacture traditional flu vaccine is ancient and
won't work in a pandemic."
The mayor's letter referred to a draft study developed by the Bush
administration that showed the country is unprepared for a widespread flu
outbreak. Part of that plan calls for an increase in domestic vaccine
production to 600 million doses, more than 10 times the present capacity.
Sommer said about 20 companies were once licensed to produce flu vaccine in
the United States but, during the past several decades, the number has
dwindled to three that make a form of vaccine that can be injected. Most
large pharmaceutical companies no longer feel the product is worth the cost
of production, he said.
Still, O'Malley said the medical community already in place in Baltimore and
nearby cities, along with financial assistance from the government, could
spur a business that has faltered elsewhere. Besides Johns Hopkins,
Baltimore is home to the Center for Vaccine Development at the University of
Maryland, Baltimore, as well two emerging biotechnology parks.
"This is what both of us had in mind when we started these projects," said
Jim Hughes, vice president of research and development for the University of
Maryland, Baltimore, which is scheduled to open its BioPark in West
Baltimore next week. "The nice thing about manufacturing is that it creates
a good array of jobs."
In addition to employment, a facility could bring millions in investment
into the city and state's biotechnology sector, officials said.
Thirteen children and an adult have caught viral pneumonia over the past
month at a Frederick County elementary school, a spokeswoman for the public
school system said yesterday.
Since the outbreak at Wolfsville Elementary School last month, two of the
sick students have regained their health and returned to classes.
Spokeswoman Marita S. Loose said the virus was passed by personal contact
rather than by any contamination of the school building.
Because of a shifting of staff workdays, Wolfsville students will have today
and tomorrow off. Loose said the school's staff members would have the
option of working from home.
Parents and staff members seeking more information can call the Frederick
County Health Department at 301-631-3342.
BALTIMORE-A Maryland public interest group charged Wednesday that toxic
chemicals used to manufacture some common baby products are endangering the
health of children.
However, a spokesman for the federal Consumer Product Safety Commission said
parents should not be "needlessly scared" by the group's report, and a
chemical manufacturer's group denounced the charge as a "scare story." The
manufacturer of one of the products said that his company doesn't even use
the chemicals it is accused of using.
The report, titled "The Right Start: The Need to Eliminate Toxic Chemicals
from Baby Products," was released at a press conference by the Maryland
Public Interest Research Group at the Downtown Baltimore Childcare Center.
The report was released simultaneously around the country by allied public
interest and environmental groups.
Ben Clinton, the Maryland group's citizen outreach director, said
potentially harmful chemicals were found in baby products such as Sassy's
"Who Loves Baby?" photo album and Playskool's Gloworm.
The report said some experts link exposure to chemicals found in these
products to health concerns such as learning disabilities, cancer,
reproductive problems and weakening immune systems.
Some of the chemicals the group said were in the products are phthalates.
Pronounced tha'-lates, they are a family of clear liquid chemicals commonly
used to make vinyl plastic flexible and to manufacture perfume, nail polish
and adhesives, according to the American Chemical Society's phthalate Web
site.
Dr. Lorne Garrettson, a retired pediatrician and toxicologist, said these
chemicals have been linked to genital malformation in male fetuses.
"To protect them, we must protect their mothers," he said. "There needs to
be an intelligent reduction of our use of phthalates."
But Scott Wolfson, spokesman for the U.S. Consumer Product Safety
Commission, said the levels of chemicals found in the tested products don't
pose any risk to children.
Parents shouldn't "be needlessly scared," he said, because these are
"extremely low levels."
Marian K. Stanley, senior director at the American Chemical Council, said
some of the chemicals measured by the study are not even used in toy
production in the United States.
"This report is doing a disservice to parents," Stanley said. "This is a
scare story that is skewing what's out there."
The Environmental Protection Agency is in charge of regulating industrial
chemicals in the United States, and the research groups want chemicals that
make humans sick to be banned.
Clinton said the Consumer Product Safety Commission should require
manufacturers to list the chemicals used in production on the packaging.
The packaging for Sassy's vinyl flexible plastic photo album labeled the
product "phthalate-free," but the researchers' tests showed it actually
contained two such chemicals. Clinton said the European Union has banned
these chemicals in children's products.
Fritz Hirsch, spokesman for Sassy, Inc., said the groups' claims are
"totally not accurate and not truthful.
"Our products are completely safe," Hirsch said. "We use safe alternatives"
to phthalates, and he said if the study showed Sassy products had the
chemicals, the study was wrong.
The research groups recommend that parents protect their children from
exposure to these potentially harmful chemicals by not using plastic for
food storage, not using harsh soaps or hot water to clean plastics and not
allowing their children to put plastic toys into their mouths.
The report recommends parents choose "PVC-free" soft plastic toys and
teethers or wooden toys for their children. Plastic shouldn't be microwaved
or washed in the dishwasher because it speeds up the process in which the
chemicals leach out of the plastic.
Wolfson said the Consumer Product Safety Commission is more concerned with
children's exposure to lead through costume jewelry and other sources.
Lead is an area "where we have tested and know the acceptable and hazardous
levels," Wolfson said. In the study performed by Paradigm Environmental
Services in Rochester, N.Y., three of seven infant sleep accessories tested
contained toxic flame retardants in the foam materials. Fifteen of 18 bath
products and teething toys tested were found to have phthalates.
Talks aim to help explain 'complicated' system; enrollment for Medicare
program to begin Nov. 15
By Lisa Goldberg
Baltimore Sun
reporter
Thursday, October 13, 2005
With her first chance to join a Medicare prescription drug plan just weeks
away, Carolyn Lockwood joined dozens of elderly Baltimore County residents
at the Lansdowne Senior Center and listened intently as presenters explained
the program's intricacies.
She tried to make sense of it all, asking question after question of the two
county Department of Aging officials at the front of the room. But she left
with more than a few questions.
"What brought me out today was to be able to understand. But you have senior
citizens here, and some of us aren't as sharp as we used to be," the
67-year-old Lansdowne resident said after the hourlong talk Friday. "It's a
very complicated plan."
With enrollment in the voluntary drug benefit plans scheduled to begin Nov.
15, officials throughout the region are holding talks such as the one in
Lansdowne. Their efforts are part of an extensive undertaking by area
jurisdictions, state government and seniors organizations to educate the
elderly and the disabled about the complex and often-confusing program.
Officials are making the rounds of senior centers, nutrition sites and
retirement communities. They're also making appearances on public-access
cable television, buying advertisements and printing booklets. They're
gearing up for a slew of phone calls from seniors who can expect to be
bombarded with information on the program's various plans in the coming
weeks. And they're warning seniors of the potential for unethical schemes.
The program, which begins Jan. 1 and relies on private insurers, marks the
first time Medicare will provide a prescription drug component - a
development that is the biggest in the federal health care program's 40-year
history, say those familiar with the plan.
Seniors in Maryland are faced with the task of evaluating dozens of options,
including a variety of premiums and lists of covered drugs. There are
deadlines for joining without penalty and opportunities for government
assistance with premiums, co-pays and deductibles.
Although the program is a federal undertaking, officials with the Centers
for Medicare and Medicaid Services recognize that help from local agencies
and officials will be crucial to seniors' understanding of the benefit, said
Gary Karr, a CMS spokesman.
"We know they're on the front lines," he said. "Seniors who need help and
assistance are often going to go to trusted sources nearby."
Local senior center directors and area aging agency officials say their help
will be more detailed - face-to-face assistance for those who may be
overwhelmed with information.
"We're the person you get without pushing 37 buttons," said Janet Wright,
who coordinates the Senior Health Insurance Program in Harford County. "We
answer the phones with a live human being. That's important to seniors."
In Baltimore County, home to 124,000 Medicare-eligible residents, the
Department of Aging expects to hold more than 150 outreach sessions through
the spring, when the enrollment period ends, said Arnold Eppel, the county's
director of aging.
For the county's Senior Expo this month - a two-day event at the Timonium
Fairgrounds that traditionally draws about 10,000 people - officials have
scheduled hourly seminars on the drug program and have set aside space for
private providers involved in the benefit to hawk their plans, Eppel said.
In Baltimore City, officials are giving several presentations on the plan.
They had also hoped to send out a mass mailing and automated telephone
message to 104,000 Medicare-eligible residents. But privacy laws made it
impossible to get individual information to compile lists, said John P.
Stewart, executive director of the city's Commission on Aging and Retirement
Education.
Stewart calls the new program a "prescription for confusion."
"Many seniors will not be able to take advantage of an important benefit
because they don't understand," he said. "There is a timeline here."
Area aging agency officials say they've been limited in what they can tell
their populations because details about participating companies, the plans
they're offering to Maryland residents and the lists of drugs covered under
each have been slow in coming. Federal officials did not announce the
companies approved to take part until late last month, and insurers were not
allowed to start marketing their plans until Oct. 1.
Still, officials say, all of the sessions have been worthwhile - if only to
alert the Medicare-eligible population that there's something new on the
horizon.
"It's a complicated program, and we're going to do our best to help
subscribers and advise them," said Jean W. Roesser, secretary of the state
Department of Aging.
In Baltimore County and elsewhere, programs have often featured a mix of
federal, state and local officials, as well as those involved in
organizations geared toward senior populations. At the Lansdowne
presentation, Social Security Administration workers were on hand to answer
questions about federal subsidies for lower-income residents.
Maryland Attorney General J. Joseph Curran Jr. said he has taken part in
programs across the state. Curran said he is concerned that the state's
Medicare-eligible population may be targeted by con artists.
"We want them to be cautious," he said.
And with so many options out there, Curran and others say seniors should
take their time in deciding whether to enroll and in choosing a particular
plan.
Joseph DeMattos, state director of AARP Maryland, said seniors can simplify
the process by making a list of what medicines they need, along with the
frequency and dosage for those drugs, and then calling 1-800-MEDICARE to see
which options would be best for them. Beginning later this month, seniors
will also be able to check online.
With the start of enrollment about five weeks away, some seniors who
attended the session in the packed, muggy room at the Lansdowne Senior
Center on Friday said the whole process has left them a bit muddled.
"I don't know which plan to pick, and I think everyone in this room feels
the same way," said Marjorie Miller, 70, the president of the senior center
council. She has attended two sessions, she said. "The more I go, the more
confused I am."
For
comprehensive coverage of Medicare changes, including links to other online
resources, go to baltimoresun.com/medicare.
Erin Harty insists she's not one of those "crazy cat ladies."
Never mind that like stereotypical impassioned cat fanatics, she is single
and lives alone. Never mind that over the past four years she has spent
thousands of her own dollars to care for nearly 40 felines.
And never mind that the management of the Westwinds Apartments in Annapolis
has threatened to fine residents who follow in her footsteps.
Ms. Harty actually prefers dogs.
Tell that to Sigrid O'Farrell. In April, the Westwinds' resident manager
posted a sign banning residents like Ms. Harty from feeding the complex's
notorious feral cat colony. Those who ignored the ban could expect a $25
fine.
Although Ms. O'Farrell declined to comment, her sign says feeding the cats
has "brought unwanted animals, not just cats, onto our community."
For Ms. Harty and others, who, over the past four years, have worked
diligently to care for the colony and reduce its size, Ms. O'Farrell's
feeding ban was a callous slap in the face.
"The management wants us to ignore the problem and hope it goes away," said
Ms. Harty, who has received $50 in fines. "The cats are not going to leave
just because we stop feeding them."
However, county Animal Control officials advise against feeding strays.
"That creates a public safety issue," Officer Justin Scally said this
morning, noting some of the cats have tested positive for rabies.
As concern over diseased cats increase across Anne Arundel County and
environmentalists' calls for their eradication grow louder, and animal
lovers like Ms. Harty increasingly find themselves in the midst of a
catfight.
"There's always been a feral cat problem," said Officer Scally, noting that
media coverage of the rabies problem is prompting more calls to Animal
Control.
It's a fight Ms. Harty is ready for. Her cat crusade began a few weeks after
she moved into the Westwinds Apartments four years ago. The sight of a
feeble kitten living in a nearby storm drain was all it took to set her in
motion.
Under the supervision of a local feral cat center, what began as daily
feedings turned into a large-scale effort, as Ms. Harty and a few other
neighbors began trapping the animals, taking them to a local vet to be
spayed or neutered, and then returning them to the Westwinds complex. She
found foster homes for 12 cats. All but one still wait adoption.
Officer Scally said Animal Control is more than willing to help people trap
cats. Once they are brought into the Animal Control offices in Millersville
though, many of the feral cats are put down because they are sick or
incapable of living with humans.
"A lot of times the cats are born into this. It's like trying to tame a
bobcat," Officer Scally said.
Thirty-two feral cats were euthanized between Oct. 4 and yesterday, he said,
which is actually down from the peak summer months. He couldn't say how many
strays were captured and not killed last week.
Only a handful of cats remain at Westwinds Apartments. But Ms. Harty says if
those animals are allowed to breed again, the population will quickly spiral
out of control.
A
horse owner and journalist who minored in animal science during her college
years at Cornell University, she believes the trap-neuter-and-return method
is the only way to reduce the cat population.
"I have a pretty solid background in animal welfare issues," said Ms. Harty.
"I'm not just some bunny hugger. I've done the research and this is the way
experts are recommending this type of problem be dealt with."
It's a problem that Jessica Frohman has seen many times. The program manager
for Alley Cat Allies, a national nonprofit clearinghouse for information on
feral and stray cats, said it's not uncommon for people to attract other
small animals, such as raccoons, by feeding strays.
Instead of prohibiting feeding, Alley Cat Allies recommends that people
monitor feedings, removing food before nightfall.
"Feeding bans have never worked," said Ms. Frohman. Alley Cat Allies also
advocates the trap-neuter-return method to reduce feral cat populations,
saying it can reduce them by up to 50 percent
The organization also suggests that apartment complexes add an extra charge
to residents with unfixed cats. Cat owners can verify their animal's status
with documentation from a veterinarian.
Feral cats are not the victim, they're the problem, says Jonathan McKnight,
associate director for habitat conservation at the Maryland Department of
Natural Resources. He said feral cat colonies wreak havoc on local bird
populations and other wildlife.
"Healthy environment means having healthy native wildlife," Mr. McKnight
said. "It takes everybody's quality of life down a notch when we lose a
species."
The American Bird Conservancy estimates cats kill hundreds of millions of
birds and more than a billion small mammals every year. Mr. McKnight said
feral cats are also a link to disease in wildlife populations, though there
have been no documented cases in Anne Arundel County. Mr. McKnight advocates
spay-neuter programs.
"The answer is not to organize outdoor feral cat colonies," said Mr.
McKnight. "The answer is to put our energy into spay-and-neutering programs
so we have an equal amount of cats and happy homes for them."
Ms. Harty is still hoping to work out an agreement with the Westwinds
management.
"If people have to fear retribution for taking an interest in the problem it
just gets worse," she said.
Published October 12, 2005, The Capital, Annapolis, Md.
Jennifer Daniels expected to be at Carroll Hospital Center for only a few
hours after being admitted in July for emergency outpatient gallbladder
surgery.
But her hospital stay stretched to four days and, according to a lawsuit
filed yesterday in Baltimore County Circuit Court, turned life-threatening
after a nurse allegedly administered intravenous insulin instead of the
antibiotics that Daniels' doctor had prescribed in the hours before her
operation.
The lawsuit filed by the 31-year-old Owings Mills woman seeks not only
financial compensation for her experience but also an end to the $12,000 in
medical bills that Daniels' lawyer says the hospital continues to try to
collect for the resulting tests, cardiac evaluation and critical-care stay.
"They're making her pay for someone else's mistake," lawyer David Ellin
said. "She was supposed to be in and out of there. But she had to be
admitted to the critical-care unit after she lapsed into unconsciousness.
They had to bring in a cardiologist from outside the hospital to examine her
at the behest of her surgeon. They should not be billing this woman."
In a written statement, Teresa Fletcher, a spokeswoman for Carroll Hospital
Center, characterized the incident as "an unfortunate medication error that
had no lasting consequences for the patient."
She said the hospital regrets the error and accepted responsibility by
offering a "fair cash settlement commensurate with Ms. Daniels'
inconvenience" and waiving hospitalization charges.
Ellin said that is not the case, offering copies of his client's medical
bills for $12,293.44. Noting that Daniels continues to suffer nightmares and
migraines that she did not experience before her hospital stay, the lawyer
said he will ask a jury to award Daniels $500,000 on top of the cost of her
bills.
Daniels, an administrative assistant with an advertising business, said
yesterday of her July 24 visit to the Carroll County emergency room: "What
scared me most was when they told me I was in critical care. ... I wondered
why I was in critical care and I still hadn't had the surgery yet."
Johns Hopkins University on Wednesday announced the launch of a partnership
between its engineering and medical schools, in which computer technology
will be used to study diseases.
The Institute for Computational Medicine, which will be funded by $8 million
in research grants over the next five years, will initially consist of 20
researchers. It will be run by Hopkins' Whiting School of Engineering, but
will involve collaboration with medical school researchers.
"Our mission is to develop a new field that we call computational medicine,"
the institute's director Raimond L. Winslow said in a statement. "We want to
immediately tackle the challenges of how we can use advanced computational
methods to analyze and model disease mechanisms."
Winslow, a a professor of biomedical engineering at Hopkins, has used
computer models to better understand how the heart works.
The institute will operate in existing university space until 2007, when it
will move to a new engineering and computational sciences building, now
under construction at Hopkins' Charles Village undergraduate campus.
The institute's startup funding includes grants from the National Institutes
of Health, the D. W. Reynolds Foundation and the Falk Medical Trust.
The company's motto is "You're Sick. We're Quick."
In the latest marriage of health care and retail, shoppers can get a quick
checkup for minor ailments while picking up a Pepsi 12-pack or filling a
prescription at four CVS stores, in Bethesda, Rockville, Bowie and Silver
Spring.
The in-store clinics, staffed by nurse practitioners, are owned by
MinuteClinic Inc., a Minnesota company that already runs 40 such facilities
in four other metropolitan areas, including Baltimore.
The idea is to make health care visits more convenient, said Michael C.
Howe, a former Arby's chief executive who heads MinuteClinic.
In the Washington area, MinuteClinic is initially targeting "mothers with
kids and careers who are very busy and are looking for a solution to those
minor ailments in their lives," Howe said.
Nurse practitioners are trained to diagnose, treat and write prescriptions
for common family illnesses such as strep throat and bronchial infections.
Patients with more serious illnesses are referred to their physicians or to
the nearest hospital.
The company has agreements with Medicare, Aetna Inc., CareFirst Inc. and
several other insurers, so many visits can be settled with a co-payment.
For cash customers, the cost of no-appointment-necessary visits can range
from $28 for pregnancy testing to $78 for a flu consultation. Vaccinations
such as flu shots ($30), tetanus/diphtheria ($38) and pneumonia ($30) also
are available.
CVS, Safeway and other retailers have long offered flu shots. And last week,
America Online Inc. co-founder Steve Case and a team of other former chief
executives announced a venture to finance clinics at retailers such as Wal-Mart
Stores Inc.
The MinuteClinic centers that opened yesterday are at the CVS stores on
Wisconsin Avenue in Bethesda, White Hall Center in Bowie, Seven Locks Road
in Rockville and Plaza del Mercado in Silver Spring. Clinic hours at those
stores are 8 a.m. to 8 p.m. Monday through Friday, and 10 a.m. to 4 p.m.
Saturday and Sunday.
"I would love to see another 20 to 25 locations in the Washington area,"
Howe said.
As Frederick County Public Schools officials work to fight childhood obesity
with new low-fat menu items, students are reacting with mixed emotions to
their new lunchtime options.
While school breakfast and lunch offerings have always been held to high
state and federal nutrition standards, the county school system is now
trying to ensure snack and a la carte options are also healthy.
Starting last month, students may purchase items such as low-fat milk,
cookies and ice cream, baked French fries, whole grain cereals and drinks
with 100 percent juice in the county’s public school lunchrooms.
‘‘All of our menu items are analyzed so there is no more than 30 percent fat
content [per meal], but kids bring their own lunch from home and supplement
them with our a la carte items, so we are taking this further,” said Peggy
Green, assistant food service officer for county schools.
At Gov. Thomas Johnson High School, the majority of students who spoke to
The Gazette this week said they liked the idea of low-fat, low-sugar foods,
but didn’t like the foods currently served to reach this goal.
‘‘I’ve tried everything offered and they are not as good,” sophomore Tim
Bentley said. ‘‘They taste like something is missing.”
Senior Rachel Fouche said she is conscious of the nutrition of her meals, a
reason she brings her lunch from home and supplements that with drinks from
the cafeteria.
‘‘If I bring my lunch, I know what I’m getting,” she said. ‘‘Good nutrition
has been drilled into my head by my mother, so I like the idea of healthier
food in schools and think there should definitely be more options.”
In February, the Maryland State Board of Education released a memorandum
requiring food service departments across the state to do their part to help
prevent childhood obesity by revamping some of the items they offer to
students. The board called for the outright ban of ‘‘foods of minimal
nutritional value,” such as certain candies and chewing gum, and required
each school system to come up with a nutrition policy to implement by the
start of the 2006-2007 school year.
In the meantime, the board encouraged schools to adopt nutritional
guidelines for food and beverages served to students, which were adopted in
Frederick County.
‘‘We were given a year to implement some actions with the purpose to provide
a healthy food environment as well as following state and federal
regulations,” Green said. ‘‘This year, our a la carte options will have no
more than 9 grams of total fat, 2 grams of saturated fat and 15 grams of
sugar.”
The food service department has also worked with a nutrition advisory
council to create a way to provide a healthy meal when time is tight.
On days when school is dismissed two hours early, students will be able to
purchase pre-packaged healthy combinations dubbed ‘‘Munchie Lunches” in the
elementary grades and ‘‘Power Pacs” for older students. The meals include
offerings such as a turkey or grilled chicken wrap with vegetables or a
peanut butter and jelly sandwich, accompanied by fruit and a snack.
‘‘We experimented to see how they were accepted and the students went for
them in a big way,” Green said.
Even that tried-and-true school lunchroom standard, pizza, is getting a
healthy makeover, with the choice between a regular or whole wheat crust.
Both options are topped with low-fat mozzarella cheese.
Helen Monk, health specialist for county schools, said she is a big
supporter of the low-fat options as another way to prevent childhood
obesity.
‘‘Low-fat diets are healthier diets,” she said. ‘‘...We need to make people
aware that they can make good food choices.”
While both Monk and Green said early feedback from parents has shown support
for the healthier options, students differ in their reviews of the new menu
items.
At Walkersville High School, most students indicated that they prefer to
bring their own lunch and really don’t dwell on the nutritional content of
in-school meals.
‘‘I don’t like school lunches because they are cold and all baked,”
sophomore Sarah Weddle said. ‘‘They should bring back the good stuff – fried
foods like french fries. As long as things taste good, we’ll eat it, so they
shouldn’t worry about kids gaining weight, because when they go home,
they’ll eat what they want.”
Freshman Rania Morfessis added that she and her friends do not focus on
calories, given their busy schedules in and out of the classroom.
‘‘If I get fat, I’ll lose the weight,” she said. ‘‘We walk around school
everyday and we’re outside all the time.”
WASHINGTON, Oct. 12 - The Food and Drug Administration announced Wednesday
that it had approved for sale about 1.5 million doses of flu vaccine from
the Chiron Corporation, whose entire production of 50 million doses last
year was condemned by the United States and Britain out of fear of bacterial
contamination. The new announcement raised hopes that there would be ample
vaccine supplies this flu season.
Public health officials had been anxiously awaiting news about whether this
first batch of Chiron's vaccine would pass muster with the F.D.A. Some state
health officials had said that if word of the approval was not announced by
Oct. 17, they would start rationing supplies.
"It's a big relief," said Kris Ehresmann, immunization program manager for
the Minnesota Department of Health.
Public health officials across the country had begun to complain about tight
supplies of flu vaccine. But Ms. Ehresmann said news that Chiron was
beginning to sell some of its promised doses would make them "more willing
to be patient."
The loss of Chiron's production last year prompted a severe shortage of
doses and led to long lines at flu clinics around the country. The company
expects to produce 18 million to 26 million doses this year, and though
other manufacturers expect to produce a total of about 70 million doses,
Chiron's supply is needed to ensure that anyone wanting a shot can get one.
That the F.D.A. has begun approving Chiron's lots suggests that the
company's entire supply may wind up at doctors' offices and flu clinics.
The largest producer of flu vaccine, SanofiAventis, has been making only
partial shipments of doses to many customers, just in case a shortage
develops again this year. This led to complaints by some public health
clinics that they did not have enough supplies.
GlaxoSmithKline, the London-based drug giant, is expected to sell about
eight million doses this year, many of which have already been approved for
sale.
The approval of the first Chiron lots is a vindication of strenuous efforts
by the company's executives and federal health authorities, who worked
together for months to ensure that its manufacturing process was up to F.D.A.
standards.
Alison Marquiss, a Chiron spokeswoman, said the company would deliver flu
vaccines through early December.
"There will be a lot of releases on an ongoing basis," she said.
WASHINGTON // Government projections that as many as 1.9 million Americans
could die in a global flu epidemic amount to a guess that could prove to be
highly inaccurate, several public health experts say.
"The problem with all the numbers is that nobody knows," said Dr. Arnold S.
Monto, a University of Michigan epidemiologist who specializes in infectious
diseases. "I try to avoid coming up with these numbers as much as possible.
I know they are based on imperfect information, extrapolating from the
past."
The figures in a draft of the government's pandemic preparedness plan have
heightened public alarm about a highly virulent strain of bird flu from Asia
that could undergo a genetic mutation, allowing it to become easily
transmissible between humans.
While agreeing that preparation for a pandemic must be an urgent national
priority, Monto and other experts say the death toll cannot be reliably
estimated at this point.
"Usually, as a virus adapts to human-to-human transmission, it becomes less
virulent," said Ira M. Longini Jr., a professor at Emory University. "A
virus that kills the host cannot transmit itself as well. From the virus'
point of view, it wants the host to live."
The worrisome strain of bird flu, known as H5N1, has spread rapidly among
domestic and wild birds in Asia. More than 100 people have been infected
with it, and about half have died. But in virtually all the cases, the human
victims are thought to have caught the virus directly from birds.
To head off a global pandemic of avian flu, some scientists are advancing a
novel strategy: that poultry workers and farmers in Asia get the same
vaccine that Americans and Europeans are given to protect against
conventional flu.
The goal, these virologists say, is to keep the Asians from becoming "mixing
vessels" for human and bird strains.
"The idea is simple," said Dr. Daniel Perez, a flu virus expert at the
University of Maryland. If a poultry worker is unlucky enough to catch both
conventional and avian flu, Dr. Perez said, the fear is that the human and
bird viruses will mix in a process called reassortment. The mixing might
create a virus that would spread easily from human to human, leading to a
global pandemic of avian flu.
But if the workers are vaccinated against human influenza, he said, "they
can't catch it, so you won't get reassortment."
Although public health experts and officials praised the idea in the
abstract, they said it would be hard, if not impossible, to carry out
because it could require diverting millions of flu shots that Americans and
Europeans are expecting to protect them this winter.
Giving the shots to anyone likely to be near infected poultry "makes sense
from a science perspective," said Thomas W. Skinner, a spokesman for the
federal Centers for Disease Control and Prevention.
Mr. Skinner declined to comment on whether the government should pay for flu
shots in poor Asian countries or should divert vaccine there.
The disease control agency is hoping there will be an abundance of flu
vaccine later this season, but demand is currently exceeding supply, and
orders are backlogged.
A
spokesman for the Department of Health and Human Services also had no
comment.
Vaccinating poultry workers against conventional flu viruses has been done
before, notably in Hong Kong in 1997, during the first brief appearance of
the lethal avian strain. The tactic was also used in an outbreak of a
different bird flu in the Netherlands in 2003.
Dr. Andrew T. Pavia, chairman of the pandemic influenza task force of the
Infectious Diseases Society of America, said shots for Asian poultry workers
were "something that we think might be extremely important."
But like other experts, Dr. Pavia said it was unlikely that Western vaccines
would be diverted because they save many lives in the United States and
Europe. Ordinary flu kills about a million people each year, including
36,000 in the United States, mainly the elderly and those with weakened
immune systems.
Dr. Klaus Stöhr, head of the World Health Organization's global influenza
program, said the proposal was "intriguing, but might not do the trick."
Dr. Stöhr said that only one of the 117 people known to have caught the
lethal strain of avian flu since December 2003 was a poultry worker. Most
victims, he said, were young and lived in rural areas.
Vaccinating everyone in those risk groups in Vietnam and Indonesia, the two
nations in which cases were increasing, would consume all the flu vaccine in
the world and cost a minimum of $3 billion, Dr. Stöhr said.
Dr. Pavia suggested that an inexpensive approach might be to reserve flu
shots for those who cull and bury or burn sick chickens. "They're exposed to
the blood and guts of tens of thousands of ill chickens," he said. "They're
the ones it makes sense to target."
Currently, the chief tactic used in Asia to avert a pandemic is to kill
every flock with infected birds and all nearby flocks. But because farmers
are not always adequately compensated for the lost chickens, they may deny
that their birds are sick.
Another tactic is to close live poultry markets for cleaning and
disinfection, but that is a temporary measure, and the virus is reintroduced
as soon as a sick bird arrives.
Conventional flu shots are not routine in Vietnam, Thailand, Cambodia and
Indonesia, the four countries where humans have caught the lethal virus,
H5N1.
One reason is cost. "If the health care budget of Vietnam is about $7 a
person, that would be enough for one flu shot," said Dr. Earl G. Brown, a
virologist at the University of Ottawa. (In the United States, the wholesale
price of a flu shot is about $10. Doctors typically charge $25 or more.)
For that reason, the money for flu shots would have to come from the West.
Dick Thompson, a spokesman for the W.H.O., said it had taken no position on
vaccinating poultry workers against conventional flu. But Mr. Thompson added
that, in general, the agency favored increasing production of flu vaccine
and making it affordable worldwide.
The virus began making its way westward through China, Mongolia and Russia
in migrating birds this summer. Birds have died of the flu in Turkey,
leading the European Union to ban the importing of Turkish poultry products,
but tests have not shown whether it is the H5N1 strain. Reports this week
that three dead birds in Romania had the H5N1 virus proved unfounded.
Flu
Effort Is Said to Lack Money
PARIS, Oct. 12 (Reuters) - Dr. David Nabarro, the United Nations coordinator
for avian and human influenza, said Tuesday that efforts to control the
spread of the flu in birds were seriously underfinanced.
"Prevention is going to be cheaper and more effective than waiting for the
pandemic to occur," Dr. Nabarro said, adding that $175 million would be
needed to control outbreaks but that the United Nations had a budget of
about $7 million.
Dr. Nabarro said Western governments had spent hundreds of millions of
dollars stockpiling flu medicines and experimental vaccines.
BRUSSELS (AP) — The European Union on Thursday said the bird flu virus found
in Turkish poultry was the H5N1 strain that scientists worry might mutate
into a human virus and spark a pandemic.
"We have received now confirmation that the virus found in Turkey is an
avian flu H5N1 virus," said EU Health Commissioner Markos Kyprianou. "There
is a direct relationship with viruses found in Russia, Mongolia and China."
Kyprianou said precautionary measures being assessed are to warn people
traveling to countries where the disease has been diagnosed to avoid "going
to farms, coming in contact with wild birds and so on."
The H5N1 bird flu strain does not easily infect humans, but 117 people,
mostly poultry workers, have caught it over the last two years and 60 of
them have died. Scientists are tracking the spread of the virus in birds
because it could mutate into a dangerous human pandemic strain.
Elsewhere, experts confirmed that a strain of the bird flu virus has been
found in samples taken from dead birds in Romania's Danube Delta, the
agriculture minister said Thursday.
The samples are being sent to Britain to identify the specific strain. So
far there are no indications it is the H5N1 strain.
"We hope it's a low intensity virus," said Agriculture Minister Gheorghe
Flutur. "We are continuing measures to isolate the affected area."
The Interior Ministry has extended a quarantine in the village of Ceamurlia
de Jos, where the infected fowl was found, to people. Only authorities are
allowed to enter and exit the remote village, which is located in the east
of the delta, close to the Black Sea.
Cooling unresponsive newborns within hours of birth reduces their risk of
death or disability, an article in Thursday's New England Journal of
Medicine reports.
The results build on increasing evidence from animal studies and some small
human trials that show that controlled lowering of the body's temperature
after injury has a protective effect. In adults, body cooling, or
hypothermia, has been recommended as a treatment after cardiac arrest by
medical societies in several countries, based on clinical trials showing a
benefit of the technique. Hypothermia also is being studied for the
treatment of stroke and brain injury.
Still, Lu-Ann Papile, a pediatrician at the University of New Mexico who
wrote an accompanying editorial to the study, says it is important to keep
in mind that, while the results are encouraging, the overall number of
babies who benefited was small. In babies who were cooled, and those who
weren't, the majority went on to have serious complications, she says. She
argues the treatment should be considered experimental.
Babies not breathing at birth used to be cooled in the past, mostly in
Europe and Russia. However, the practice fell out of favor after studies
showed that premature babies did better when warmed.
But interest in the cooling technique for full-term babies has recently
rekindled, with several research teams around the world performing
randomized clinical trials in babies born unresponsive because not enough
oxygen had reached their brain. This happens in about two in every 1,000
births, studies have shown, with 15% to 20% of those babies dying and 20% to
25% ending up disabled.
Lack of oxygen in the brain leads to a "domino effect" of damaging events
that include damage to brain cells and swelling, says Marianne Thoresen, a
British researcher whose group published the results of a clinical trial of
newborn hypothermia earlier this year. "What hypothermia does is stop a lot
of the damaging processes, and it's not like they start again when you
rewarm," she says. "In a way, everything is calmed down when cooled."
In today's NEJM study, the second large-scale newborn hypothermia trial to
be published, babies enrolled in the 15-hospital study had to be full-term,
not premature, and show evidence that they were unresponsive as a result of
a lack of oxygen to their brain, not another reason, like an infection, says
Seetha Shankaran from Wayne State University, the trial's principal
investigator. The babies had to be treated within six hours.
Doctors used cooling blankets to lower the babies' temperature to 33.5
degrees Celsius (92.3 degrees Fahrenheit) for 72 hours from around 37
degrees Celsius. "We know from previous experience that below 30 degrees you
start seeing complications," says Dr. Shankaran. The babies were slowly
warmed after the treatment.
Of the 102 babies who were given the cooling treatment, 44% died or suffered
a disability in follow-up tests at a later age, as compared with 62% of the
106 babies who weren't cooled.
Dr. Shankaran and others expressed concern that doctors might prematurely
adopt the hypothermia method. Rosemary Higgins, an investigator with the
National Institute of Child Health and Human Development, which sponsored
the study, says the institute currently is working with the American Academy
of Pediatrics to develop recommendations on cooling oxygen-deprived babies.
With the pace of basic scientific research accelerating, the National
Institutes of Health launched a program yesterday aimed at speeding the
process of turning fundamental discoveries into medical treatments for
patients.
The NIH announced plans to offer a new type of grant to medical research
centers around the country to find innovative ways to bring together
scientists who do not usually collaborate to move advances toward practical
applications.
"We are truly at a crossroads in medicine," said NIH Director Elias A.
Zerhouni, who briefed reporters in a teleconference. "The scientific
advances of the past few years . . . dictate that we act now to encourage
fundamental changes in how we do clinical research, and how we train the new
generations of clinician scientists for the medical challenges of this
century."
Under the program, the NIH, which has an annual budget of $28 billion, will
award four to seven grants in the first year totaling $30 million, plus
$11.5 million for 50 "planning grants" for institutions that are not ready
to make full applications. The NIH will increase the grants each year after
that so that by 2012 60 grants will be handed out, totaling $500 million per
year, officials said. The money will come from existing NIH programs.
"We are taking great care to preserve the investigator-initiated research
support pool in these times of constrained budgets," Zerhouni said.
The new program was spurred by growing concern that medical research
institutions were ill-equipped to exploit practical applications of basic
discoveries, a field of research known as "translational research."
"Translational research is the kind of research we do between a fundamental
discovery and the application of that discovery to medicine," Zerhouni said.
"People perceive that there is an increasing gap of knowledge between those
two -- the bench and the bedside."
For example, one of the most exciting fields in biomedical research today is
an area known as "proteomics," which is the study of proteins and the genes
linked to them. Scientists have mapped the human genetic blueprint, which
has led to an explosion of research into the proteins and how genes direct
cells to produce them. The key now is to translate that explosion into
treatments, Zerhouni said.
"The potential is enormous for progress, and this is what we want to
stimulate," Zerhouni said. But, he added, that requires bringing together
scientists from disparate fields who may not typically work together.
"What we want to do is create a real home, an intellectual home and place
within that institution where they can come and work," said Zerhouni, who
outlined the new program in this week's issue of the New England Journal of
Medicine.
The program drew praise from scientists and advocacy groups.
"I think it's very exciting," said David Korn of the Association of American
Medical Colleges. "It will be very interesting to see the kinds of proposals
that come out."
Some, however, cautioned that the NIH needed to make sure the program, like
the NIH's spending overall, treated all diseases equitably.
"With federal budgetary constraints eliminating NIH research funding
increases, existing NIH funds must be redirected so that the goals of this
new discipline are realized for all diseases and to ensure NIH allocations
are fairer and more equitably distributed," said Richard Darling of the FAIR
Foundation, an NIH watchdog group.
Federal drug regulators have agreed to consider allowing a Pennsylvania
company to sell the first rapid, at-home AIDS test that would make testing
for the virus about as easy and accessible as a pregnancy screen. The move
could put to rest 18 years of controversy.
Officials at the Food and Drug Administration and AIDS advocates long
worried that people who got an AIDS diagnosis would panic and even consider
suicide. So for years, the federal drug officials have insisted that
counseling and professional support accompany AIDS tests. This requirement
has complicated proposals for at-home tests.
But improved medicines now mean that AIDS is a chronic disease that can
often be managed for years, so the fear that a diagnosis might lead to
thoughts of suicide have subsided. Just as important, 40,000 people each
year continue to be infected by HIV, the virus that causes AIDS. This rate
has remained stubbornly high for years. Having tried many other strategies,
federal health officials are now increasingly open to the idea that an
at-home AIDS test could finally lead thousands to change their behaviors and
stop infecting others.
"If we're going to win the war against AIDS, we need to make HIV testing as
easy as pregnancy testing," said Dr. Freya Spielberg, a researcher in the
Center for AIDS Research at the University of Washington.
A
federal advisory board will discuss the proposal for an at-home AIDS test on
Nov. 3. After that, the test's maker, OraSure Techologies, based in
Bethlehem, Pa., said that it would likely apply formally to sell the device
over-the-counter.
The test, called OraQuick Advance Rapid HIV-˝ Antibody Test, is presently
sold only to doctors and clinics. It has already proven to be effective,
safe and easy to use. So the remaining hurdles are decisions by the F.D.A.
about whether approving such a device is a good idea and whether people can
understand the product's label well enough to administer it to themselves.
A
1987 application for an at-home AIDS test kit led to years of controversy.
At the time, AIDS advocates and public health officials predicted that such
a test would cause widespread suicides, panic and a rush to public health
clinics.
At hearings, AIDS advocates handed out copies of an obituary of a San
Francisco man who jumped off the Golden Gate Bridge after discovering that
he was infected with HIV. An official for the Centers for Disease Control
and Prevention told the F.D.A. that such tests could lead to "a sudden
increase in referrals to already overburdened health clinics," according to
an F.D.A. document.
Federal regulators stalled the application for nine years, and at-home AIDS
testing never caught on.
Some AIDS advocates are now warily supportive of at-home testing.
"For people who don't have access to a clinic or make a decision not to go
to a clinic, this is better than nothing," said Gregg Gonsalves of Gay Men's
Health Crisis in New York City, which opposed at-home AIDS testing 18 years
ago and offers testing and counseling itself. "But it's not a magic bullet."
The switch by advocates is important. Politics have long played a crucial
role in many F.D.A. decisions, according to longtime agency observers and
previous agency officials. Recently, the agency decided to delay a decision
on whether to allow over-the-counter sales of an emergency contraceptive.
The decision was seen by some inside and outside of the agency as
politically driven, and it led a top agency official to resign in protest.
Dr. Spielberg said that about a quarter of the nearly million people in the
United States who have the HIV virus in their blood do not know that they
are infected. And somewhere between 40 percent and 45 percent of those who
test positive for HIV do so less than a year before they are diagnosed with
AIDS.
Since an HIV infection often takes a decade to develop into full-blown AIDS,
"this suggests that people are living with HIV, and spreading HIV for many
years before they are aware of their infection," she said.
Many of these people avoid getting tested in clinics for a variety of
reasons, including fear of discovery and convenience, studies show. And many
hate having to wait more than a week for a lab result, surveys show.
Dr. Spielberg said that she surveyed 240 people infected with HIV and found
that more than half said that they would have preferred to have found out
about their infection with a rapid at-home test.
Having a rapid, over-the-counter test widely available, Dr. Spielberg said,
"is the most powerful strategy we have to bring down HIV infections." People
who find out that they are infected with HIV often change their sexual
behavior to reduce further infections, she said.
By contrast, OraQuick requires a person to simply swab their gums and then
place the swab in a holder. Twenty minutes later, a strip displays one line
for a negative result and two lines for a positive one.
The argument against at-home tests has long been that they failed to ensure
that patients would get adequate counseling. Activists now acknowledge that
many people who get HIV tests in doctors' offices get little or no
counseling anyway.
"The counseling that now occurs is very short or abrupt in many settings,"
said Gene Copello, executive director of The AIDS Institute, a
Washington-based policy group.
Doug Michels, president and chief executive of OraSure, said he plans to
include advice about counseling on OraQuick's label. "It could be a hotline
number, a 24-hour manned counseling center, Web support or printed material
that is included in the product," he said.
The company said it would include whatever the advisory committee and the
F.D.A. deems is necessary, he said. The company now sells the device for
between $12 and $17, although the price of an over-the-counter version has
yet to be decided, Mr. Michels said.
A
long-awaited report on the 2004 Food and Drug Administration decision to
reject an application to allow easier access to the "morning after pill"
concludes that the decision was highly unusual, was made with atypical
involvement from top agency officials, and may well have been made months
before it was formally announced.
The draft report by the Government Accountability Office, requested by
Congress in the summer of 2004, is to be finalized and made public by the
end of the month. But some congressional staffers have been briefed on its
conclusions in recent weeks, and some were allowed yesterday to read the
findings.
As described by some familiar with the draft, the GAO found that top FDA
officials participated in assessing the application to allow the emergency
contraceptive Plan B to be sold without a prescription, and that such
unusual high-level involvement was justified by the perceived sensitivity of
the issue.
Critics of the FDA's May 2004 decision, and of a subsequent postponing of
any decision making this August, have accused the agency of giving in to
political pressure from social conservatives opposed to the application.
While an FDA advisory panel overwhelmingly supported the proposal in late
2003 on scientific grounds and the agency's medical reviewers were similarly
convinced it should be approved, the agency's top leaders have said it could
not be approved because of outstanding questions about whether it should be
available to young girls, and if not, how to keep it from them.
When Steven Galson, then-acting director of the Center for Drug Evaluation
and Research, announced the rejection, he said the decision was his own, had
been recently made and was based on scientific concerns. The GAO report,
however, indicates the decision was solidified months earlier and that other
top officials were involved in the decision.
The 2004 decision was announced when then-acting Commissioner Lester M.
Crawford was in charge, having taken over for Commissioner Mark McClellan in
March. Crawford resigned with little explanation last month, only two months
after being confirmed by the Senate following a heated battle over the Plan
B application.
The draft GAO report indicates that Galson voiced concerns in FDA meetings
about how easier availability of Plan B would effect sexual behavior by
girls.
Plan B consists of the high dose of a common contraceptive, and can prevent
pregnancy if taken within 72 hours of having unprotected sex. The FDA does
not consider the drug to cause an abortion, but some religious groups
believe that under some circumstances it can cause a fertilized egg to die.
Two safer new vaccines against whooping cough could prevent up to a million
cases among U.S. teenagers and adults each year and keep them from infecting
children, who can die from the illness, a government study found.
The vaccine, tested on nearly 2,800 people ages 15 to 65, proved 92%
effective in preventing infection with the highly contagious germ. Whooping
cough, or pertussis, can cause weeks of misery and coughing so severe it
cracks ribs. The bacterial disease can kill children, particularly
unvaccinated babies.
Cases of whooping cough dramatically declined over the past half-century
because most children get several shots against it by age six. However,
immunity wears off over time, and outbreaks among U.S. adults and teenagers
began rising sharply during the 1990s. According to the National Partnership
for Immunization, teens and adults now account for about 60% of whooping
cough cases.
Last spring, the Food and Drug Administration approved two new booster
vaccines: Boostrix, made by GlaxoSmithKline PLC, is for 10- to 18-year-olds,
and Adacel, from Sanofi-Aventis SA, is for people 11 to 64; both include
boosters against diphtheria and tetanus.
The pertussis portion of those vaccines is identical or similar to the shot
used in the study. The new vaccines use purified parts of the pertussis
bacterium to build up patients' immunity. Older vaccines contain the whole
germ and are more likely to cause side effects, including fever, jitters,
drowsiness and loss of appetite.
The study will be reported in Thursday's New England Journal of Medicine.
Students, health-care workers and other volunteers at eight U.S. medical
centers got the pertussis vaccine or, in the half serving as a comparison
group, a hepatitis A vaccine. They were followed closely through the late
1990s for 22 months on average. Just one person in the pertussis vaccine
group became infected. Nine in the comparison group were infected.
The researchers estimated there are a million U.S. cases of pertussis each
year among people 15 and older. But most of those cases go undiagnosed.
In an accompanying editorial, Scott A. Halperin of Dalhousie University in
Halifax, Canada, but said more research is needed on the vaccine's use in
pregnant women and the elderly.
The study was supported by the National Institutes of Health under an
agreement with Glaxo.
Pfizer Inc. won a U.K. court ruling protecting a key patent on Lipitor, the
world's best-selling drug, until 2011. The shares rose the most in almost
eight months.
Justice Nicholas Pumfrey, at the High Court in London, yesterday rejected a
challenge to a Lipitor patent by India's Ranbaxy Laboratories Ltd., which
wants to release a generic version of the cholesterol-lowering drug. About
21 percent of New York-based Pfizer's annual revenue comes from Lipitor,
which had global sales of almost $11 billion in 2004.
Analysts and investors said the U.K. decision may influence investor views
on the strength of Pfizer's patents in the U.S., where Ranbaxy pursues a
similar legal challenge. A Delaware federal court is expected to rule in
that case later this year.
“Lipitor is the driver of the company right now,'' said David Heupel, who
helps manage about $2.5 billion at Thrivent Financial for Lutherans in
Minneapolis, including Pfizer shares.
“I don't want to assume that all is well until we hear from our U.S.
courts.'' Ranbaxy spokesman Charles Caprariello said the company will
appeal, and Justice Pumfrey told the court he would give the companies
additional time to file an appeal.
Shares in Pfizer, the world's biggest drugmaker, rose 75 cents, or 3.1
percent, to $25.05 as of 9:53 a.m. in New York Stock Exchange composite
trading, after jumping as much as 4.8 percent earlier. The shares jumped 6.9
percent on Feb. 18. They dropped 20 percent in the 12 months prior.
`Fundamental principle'
“This court decision is consistent with the fundamental principle that
patent laws exist to support and encourage medical innovators, not undermine
them,'' Pfizer Chief Executive Officer Hank McKinnell said in a statement
yesterday.
Pfizer spokesman Bryant Haskins declined to comment beyond the statement and
said general counsel Jeffrey Kindler was unavailable for interviews.
The U.K. accounted for 6.6 percent of global Lipitor revenue in 2004, said
UBS analyst Carl Seiden. Ranbaxy had asked the court to invalidate Pfizer's
U.K. “species'' patent on the drug and to declare that it wasn't infringing
a patent on the drug's basic chemical compound, known as the “genus''
patent. The court invalidated the “species'' patent, but left the “genus''
patent intact.
Pfizer argued the first patent expires in Britain in 2010 and the second in
2011.
“There's still a number of legal battles yet to come,'' Thrivent Financial's
Heupel said. “As we see more of these decided in big pharma's favor, it at
least gives you a sense of confidence that these products and their
intellectual property should be able to sustain up until the point where
their expiration occurs.''
Holger Geissler, a fund manager at Deutsche Bank AG's DWS Investment GmbH,
said in an interview that yesterday’s ruling involving Pfizer also affect
competitors such as Sanofi-Aventis SA, Bristol-Myers Squibb Co. and
AstraZeneca Plc because each will probably also face patent challenges.
“It's good news for Pfizer and a bit of a sigh of relief for other bodies in
the industry as well,'' Mike Ward, an analyst at Code Securities, said in an
interview. “In essence, it's good news for the branded industry. Sense has
prevailed.''
Other
cases
Other patent cases pending include Forest Laboratories Inc.'s $1.6
billion-a-year antidepressant Lexapro and Plavix, the blood-thinner that
generated $3.3 billion in sales last year and which Bristol-Myers co-markets
with Sanofi Aventis.
The non-jury trial against Ivax Corp. and India's Cipla Ltd. over Lexapro is
scheduled to begin in December in Wilmington, Del., before U.S. District
Judge Joseph Farnan, the same judge that's handling the Lipitor case.
The Plavix trial, which is against Canadian drugmaker Apotex Inc., is
scheduled to begin in April in New York.
The case is Ranbaxy v. Warner-Lambert HC040CO2059.
When Bracha Klausner returned home after an extended hospital stay for a
ruptured intestine three years ago, she found stacks of mail from doctors
and hospitals waiting for her.
There were so many envelopes - some of them very thick - that at first, Mrs.
Klausner, 77, could not bring herself to open them, and she stored them in
large shopping bags in her Manhattan apartment.
When she finally did open some of the envelopes, there were pages filled
with dozens of carefully detailed items, each accompanied by a service code:
"Partial thrombo 2300214 102.00," "KUB Flat 2651040 466.00."
On the 15th page or so of each bill, a "balance forward" line listed amounts
in the tens of thousands of dollars. One totaled $77,858.04.
Another mailing, from her insurance company, clearly said, in large type,
"This is not a bill." But she could make no sense of the remark codes: "G7 -
Your benefit is based on the difference between Medicare's allowable expense
and the amount Medicare paid" or "QN - Your claim may have been separated
for processing purposes."
Mrs. Klausner's experience is shared by millions of Americans who,
frustrated and confused, find themselves devoting enormous amounts of time
and energy to sorting out their medical bills.
Walk into any drugstore, and the next few minutes of your life are fairly
predictable. After considering the choices, you make your purchases and head
for the cashier. Seconds after the transaction, you are handed a receipt
that reports to the penny what you paid for each product, along with its
brand, its size, and the date, time and location of the purchase. But become
a patient, and you enter a world of paperwork so surreal that it belongs in
one of Kafka's tales of the triumph of faceless bureaucracies. And although
some insurers and hospitals are trying to streamline and simplify bills, the
efforts have been piecemeal.
Medical paperwork is a world of co-payments and co-insurers, deductibles,
exclusions and contracted fees. Nothing is as it seems: patients receive
statements that often do not reflect what is actually owed; telephone calls
to customer service agents are at best time-consuming and at worst
fruitless. The explanations of benefits that insurers send out - known as
E.O.B.'s - are filled with unintelligible codes.
The system is so impenetrable that it mystifies even the most knowledgeable.
"I'm the president's senior adviser on health information technology, and
when I get an E.O.B. for my 4-year-old's care, I can't figure out what
happened, or what I'm supposed to do," said Dr. David Brailer, National
Coordinator for Health Information Technology, whose office is in the
Department of Health and Human Services. "I can't figure out what care it
was related to or who did what."
Dr. Blackford Middleton, a professor at Harvard Medical School with special
training in health services research, said he did not fare much better than
Dr. Brailer.
"I understand the words of diagnoses and procedures," he said. "But codes?
No. Or how things are paid or not paid? I don't understand that."
Dr. Brailer said he often used an analogy to describe the current state of
medical billing.
"Suppose you walk into a restaurant," he said, "and you don't get a menu,
you don't get any choice of what food you'll eat, they don't tell you what
it is when they're serving it to you, they don't tell you what it's going to
cost."
"Then, weeks or months later, you get a bill that tells you all the food you
ate and the drinks you had, some of which you remember and some you don't,
and although you get the bill, you still can't figure out what you really
owe," Dr. Brailer said.
Some people make valiant efforts to sort through bills and claims, but end
up throwing up their hands; others ignore them, until they are pursued by
collection agencies; still others, basically healthy but weary at the
prospect of a paperwork fusillade, stop going to the doctor altogether.
Piles
Upon Piles
In the days before managed care, most insurance plans operated on a
fee-for-service basis. Patients paid 20 percent of medical fees; insurers
paid 80 percent. But as health care costs have continued to rise, many
patients are being required to pay an ever-larger part of their medical
bills, and deductibles continue to increase. And to keep the system
churning, close to 30 cents of every dollar spent on health care goes for
administration, much of it spent generating bills and explanations of
benefits.
"The number of bureaucrats between the point of service and the final cash
reckoning is just incredible," said Dr. Thomas Delbanco, a professor of
primary care medicine at Harvard Medical School who is a leader in the field
of patient-centered care.
For many people, the piles of paperwork they must contend with reinforce a
simmering discontent with a system that aggravates tensions among patients,
hospitals, doctors and insurers.
Insurance companies are, by and large, unapologetic.
"Even though the amount of paperwork a patient has to deal with might seem
to be a lot, it would be much worse if there wasn't a unifying organization
like a health plan easing that burden," said Dr. Alan Sokolow, chief medical
officer at Empire Blue Cross Blue Shield in New York.
This might come as a surprise to Ellen Mayer, an artist who lives in
Chester, N.Y. Ms. Mayer, 54, has a rare type of gastrointestinal cancer that
requires constant monitoring through blood work, CT scans and PET scans.
The paperwork nightmare started for Ms. Mayer when her oncologist switched
hospitals. Everything suddenly seemed to need a justification, or a new
piece of paper with an authorization.
The stacks of papers, folders and Post-It notes related to Ms. Mayer's
treatment have started to take over her house. They fill manila envelopes,
boxes and files, which fill closets. They spill from the dining room table
onto chairs.
"You can't just be sick," she said. "You have to be sick and be drowning in
paperwork."
So overwhelming has the paperwork grown that Ms. Mayer has considered giving
up and ceasing all treatment because of the bureaucratic hassle that
accompanies it.
"It's comical, it's unbelievable," she said. "And I think to myself, 'What
if I was an elderly person, or a single person? What if I wasn't healthy
enough to handle it?' "
Dr. Michael Mustille, associate executive director of the Permanente
Federation in Oakland, Calif., said medical paperwork often delivered "a
double psychological whammy."
"People get these things that look expensive that they can't understand,"
Dr. Mustille said, "and then there's the worry that the people they've paid
for insurance may decline to assume responsibility for it."
In Mrs. Klausner's case, her son bought her an elaborate paper organizer,
hoping it might help her face the chaos. She never used it.
Creditors began to call. Whenever a collection notice showed up, Mrs.
Klausner panicked and wrote a check or reached for the telephone to call her
son for help.
In the end, Medicare and United Healthcare paid most of Mrs. Klausner's
bills, which added up to more than $150,000. And although the unwelcome mail
has ceased, she cannot bring herself to throw out the bags filled mostly
with unopened envelopes dating back to 2002, as if doing so might violate a
law.
Dr. Middleton went through something similar with his elderly mother, Dugan
Middleton, a former nurse who died of thyroid cancer last February at age
79.
Mrs. Middleton, who had lived alone in Palm Beach Gardens, Fla., preferred
to handle the paperwork herself.
"It went on and on, with her reconciling her accounts with a lot of
different doctors," Dr. Middleton said.
He said that his mother wrote check after check and that "I'm sure she was
paying many of the same bills twice."
His medical credentials notwithstanding, Dr. Middleton was at a loss. "It
was ridiculously complex," he recalled.
Finally, in the last months of his mother's life, Dr. Middleton hired a
social worker who knew how to navigate the system to help with the bills.
How did things get this bad?
Most health care in the United States is fragmented and profit-driven, a
system in which everyone but the patient is meant to benefit financially.
"Fragmentation is a fact of life in health care, and people consider that to
be one of the most fundamental problems," Dr. Brailer said. "We pay by the
piece. Everybody gets paid individually to do something: to see a patient,
to admit someone, to do a lab test, to do a prescription, so health care is
swamped by detailed, line-item bills."
After an office visit, a physician sends a diagnostic code to the insurer,
which then decides the level of payment. These codes differ from the codes
the insurer uses in the E.O.B.'s it sends to patients to explain its
decisions.
The billing codes used by hospitals are something else entirely.
"Each of them has their own system of paperwork, with their own billing
codes," said Ron Pollack, executive director of Families USA, a health care
advocacy group.
"Everyone is bogged down by this: the physicians, the hospitals, and
ultimately it reverberates to the consumer," Mr. Pollack said. "And to the
extent the consumer sees the bill, it's like reading hieroglyphics."
Mr. Pollack and other health care experts said they believed that only a
small percentage of people end up calling their insurance company to inquire
about a claim or to dispute a decision. Still fewer call a hospital to go
over a bill they believe might contain errors.
The
Navigator
In late 2003, Bonnie MacKellar's son Elias, then nearly 2, stopped eating.
Then he stopped talking and walking. Elias had stage IV neuroblastoma, a
highly malignant tumor of the nervous system.
Though pushed to their emotional limits, Ms. MacKellar and her husband,
Thomas Dube, refused to buckle until the bills started to appear in the mail
each day: hospital bills amounting to tens of thousands of dollars; invoices
from doctors she did not remember meeting; E.O.B.'s from her insurance
company that explained nothing.
"It is hard to describe what it is like to be confronted with mounds of
scary claims and bills when you have a 2-year-old who is extremely ill, who
needs constant nursing and doesn't have a great chance of surviving," Ms.
MacKellar said. "And to sit in a hospital room, on hold with the insurance
company for 30 minutes or more only to have your child start puking just as
you get a rep on the line."
The E.O.B.'s seemed to serve little purpose beyond engendering fear. They
were detailed enough ("radiology services 2/19/04"), but when it came to
understanding the boxes listing the amounts charged, the amounts not
covered, the fees allowed, the available benefit and the remark code (IT,
29, and the ever-mysterious QN ), Ms. MacKellar and her husband were at a
loss.
One statement that said, "Plan pays $00.00, patient pays $56,750.00," caused
panic.
The remark code "07" stated, "These charges are for services provided after
this patient's coverage was canceled."
There had been no cancellation of coverage, but convincing the insurance
company of that fact was an ordeal.
The breaking point came when the group number on the health plan changed,
and Ms. MacKellar was unable to convince the insurance company that it was
billing under the wrong number.
In despair, she consulted a social services agency, which put her in touch
with Lin Osborn, a private consultant fluent in the arcane language of
health care billing. For a fee, Ms. MacKellar was told, Ms. Osborn could
take all the paperwork off her hands.
An expert in deciphering insurance and hospital billing codes, Ms. Osborn
spent several days straight working on the case and took care of the entire
mess, Ms. MacKellar said.
Still
Searching
Although there is no single solution to the medical billing morass, Dr.
Brailer, of the Health and Human Services Department, said that the
increasing use of electronic records to enable insurers, physicians,
hospitals and pharmacies to share data would help.
And in some segments of the health care system, efforts are being made to
simplify and cut down on paperwork. Some insurance carriers, for example,
are reducing the number of E.O.B.'s they send out, posting them online
instead.
For the past 18 months, Blue Cross Blue Shield of North Carolina has been
working to reduce the total amount of paper it sends out.
"When there's no remaining financial liability, then we don't send the
E.O.B.'s," said Bob Greczyn, president of Blue Cross Blue Shield of North
Carolina.
Blue Cross Blue Shield of South Carolina is offering physicians an
electronic card reader that lets patients find out how much they owe while
they are still in the doctor's office.
In another effort to improve the system, the Patient Friendly Billing
Project, led by the Healthcare Financial Management Association, is working
with insurance companies on a long-term project to make bills more
comprehensible.
Still, Dr. Brailer said that, on the whole, "there isn't a lot under way" in
terms of efforts to fix the system.
Dr. Brailer pointed out that there had been frequent calls for a
standardized insurance billing form, which would sharply reduce duplication
and paperwork costs and "make patient management of these as simple as
online checking."
But, he said, "this has not gone beyond the wishful-thinking level because
the changeover would cost a lot."
Mitch Mayne, 38, is a marketing executive in San Francisco who considers
himself basically healthy.
Mr. Mayne went to his doctor three times between March and June for the same
thing: recurring bronchitis.
Yet the explanation of benefits statements he received from his insurer
after each office visit differed drastically in the amount he owed, varying
from $10.66 to $90, with no explanation of the services provided.
"What did I do on June 27 that was different than what I did on April 6 that
was different than what I did on March 4?" Mr. Mayne asked.
When he calls for an explanation of the E.O.B.'s, he said, the most tangible
result he sees is a new card in the mail with no indication of the amount he
owes as a co-payment printed on the card.
"I'm paying through the nose for this premium, and when I go to the doctor
it's a roll of the dice as to whether or not they'll pay it," said Mr.
Mayne. "It seems like it depends on the mood of whoever happens to be doing
the claim that day, or on the phases of the moon."
Mr. Mayne recently grew so fed up that he decided to try to beat the
bronchitis on his own. "I can't deal with all this paperwork," he recalled
saying. "It's just too much of a hassle." That turned out to be a mistake.
Mr. Mayne became so sick that he finally relented and saw his doctor.
What if something truly catastrophic should happen to the state of his
health?
"Oh wow, I hadn't even thought of that," Mr. Mayne said. "That's actually a
pretty scary proposition. If I can't manage my health care as a healthy
individual, the prospect of trying to manage it and be really sick at the
same time - I don't know that I could do it."
WASHINGTON // The Supreme Court took up the case of a Los Angeles County
prosecutor yesterday to decide whether the nation's 21 million public
employees have a First Amendment right to speak out about problems that
arise on the job.
Most of the justices said they were not willing to create such a right,
arguing it could turn every workplace dispute into a federal court battle.
"You are advocating a sweeping rule," Justice Anthony M. Kennedy told a
lawyer for prosecutor Richard Ceballos. "The First Amendment isn't about
policing the workplace."
In the past, the court has said that teachers and other public employees
have a right as citizens to speak in public on a "matter of public concern."
Under this ruling, the employees cannot be fired or punished by employers
who are unhappy with what they said. However, the justices have also said
that government workers who speak out on internal workplace disputes are not
protected by the First Amendment.
The case of Garcetti v. Ceballos falls somewhere in between.
Five years ago, after the news of a Los Angeles police scandal, Ceballos was
told that a sheriff's deputy might have exaggerated evidence to obtain a
search warrant in a drug case.
Ceballos, a deputy district attorney, investigated the case and wrote a memo
accusing the officer of lying. A supervisor asked him to tone down the memo,
but his second version also accused the officer of "clearly misleading" the
magistrate.
Supervisors pressed ahead with the drug case nonetheless, and a judge upheld
the search warrant despite the evidence turned up by Ceballos, which was
disputed. After he was passed over for a promotion and transferred to
another office, Ceballos sued L.A. County and then-District Attorney Gil
Garcetti, alleging his First Amendment right to free speech was violated
when he was punished for acting as whistle blower.
In 2002, a federal judge threw out his lawsuit, saying on-the-job memos are
not protected by the First Amendment. Last year, the 9th U.S. Circuit Court
of Appeals revived his suit, saying that whistle-blowers who disclose police
misconduct should be protected.
The suit has not gone to trial, and the Supreme Court took it up to clarify
the legal rights of public employees.
During yesterday's arguments, lawyers for L.A. County and the Bush
administration urged the court to throw out the lawsuit and to rule that
on-the-job speech is not protected by the Constitution.
Cindy S. Lee, a lawyer representing the county, described the memos written
by Ceballos as examples of "job-required speech." "Our view is that
job-required speech should not be protected by the First Amendment," she
said.
What about a public university professor who is fired for giving a
controversial lecture, asked Chief Justice John G. Roberts Jr.
Lee responded that the lectures were part of the professor's job.
During oral argument, Bonnie Robin-Vergeer, a Public Citizen lawyer,
represented Ceballos and said public employees should be protected by the
Constitution for "expressions on a matter of public importance."
Kennedy took issue with that approach. "Any comment about problems in a
government office is a matter of public concern," he said.
For at least the past six years, senior citizens 85 or older have made up
the fastest growing segment of the population in Washington County.
But the growth in life expectancy hasn't always been matched by development
of ways to help senior citizens deal with everything from the search for
affordable dwellings to end-of-life arrangements.
To assist with such issues, a group of local organizations has formed the
Washington County Longevity Impact Group. It's one of 350 such groups across
the nation working on the problems with the White House Conference on Aging.
In 1999, The Herald-Mail did a series of articles entitled "The Future of
Families." The section on senior citizens is as relevant today as when it
was written.
The articles noted that although there seemed to be enough nursing homes and
assisted-living centers in the county to deal with those who require such
services, government assistance doesn't always cover the full cost of such
services.
But for low-income seniors and those with psychiatric problems, there aren't
enough spaces for all who will need low-cost dwellings and special
mental-health services.
As a result, experts on aging recommended members of the baby boom
generation should think seriously about increasing the rate at which they
save and consider looking into long-term care insurance.
Seniors also need to think about different living arrangements if they want
to remain active outside of an institutional setting. The idea of a roommate
or two may seem daunting to someone who has been accustomed to living alone,
but having someone with whom to share expenses and household chores may suit
many people better than a solitary existence.
Barring an accident or illness, all of us will be senior citizens. It is up
to the community to do as much as possible to keep seniors healthy and
comfortable, no matter what their income levels.
That means supporting facilities such as Holly Place and Holly Place II, two
Hagerstown assisted-living centers set up to take care of the indigent
elderly.
It also means taking time to check on and visit with seniors who are
neighbors or relatives, so that they stay connected to the present-day
world. Such contact will also help the rest of us remember the sacrifices
that so many made in the past to get us here.
As with Katrina, pandemic threat exposes nation's lack of defense.
USA
Today
Editorial
Thursday, October 13, 2005; Page 11A
You can't pick up a newspaper or magazine these days without seeing “bird
flu” headlines. “Avian flu fears spur Tamiflu demand,” reports USA TODAY.
“How scared should we be?” asks Time.
The answer: Not very, at least just yet. But another emotion is very much in
order. Exasperation — at how ill-prepared the nation is for a flu pandemic,
something that occurs on average every 30 years. The most deadly struck in
1918, killing as many as 50 million worldwide. This one has been tracked for
years. The story so far: Since December 2003, a virus known as H5N1 has
killed millions of birds in Asia. It's believed to have spread recently to
birds in Turkey and Eastern Europe. In rare cases, it has jumped from bird
to human, infecting 117 people and killing more than 50% of them.
The concern is that it could mutate into a virus that is easily passed among
people. That hasn't happened. But if it does, H5N1 could spread globally
with the jetliner speed.
The right weapons are preparation, adaptability and clearheaded analysis. In
Washington, so far, that is sorely lacking.
Health and Human Services Secretary Michael Leavitt is traveling in Asia to
boost global cooperation and flu surveillance. Last Friday, President Bush
held a meeting with drug companies to encourage them to increase their
capacity to make vaccines. Last month, the Senate approved $3.9 billion to
bolster flu readiness.
That's all helpful, but late and scattershot. The White House meeting
produced no policies. The $3.9 billion isn't a sure thing, unless the House
of Representatives agrees.
No doubt the Bush administration's scurrying owes much to a feared repeat of
its bungled performance after New Orleans' flooding, a disaster that, like a
flu pandemic, had been predicted for many years. Even with that incentive,
preparation is far behind:
Medication.
There's no known cure for bird flu, but the government is stockpiling
antiviral drugs that might be effective in treating it. Even so, supplies
are short, less than enough for 2% of Americans.
Public health officials say they are negotiating to buy enough medicine to
cover 20 million people. Don't hold your breath. The United States is in
competition with other countries. And making Tamiflu takes 10 months.
Vaccines.
The key weapons are a proven vaccine and, once it's identified, companies
willing and able to make it fast. But only a handful of U.S. companies are
in the vaccine business, let alone ready to ramp up production. New policies
are needed to assure manufacturers they won't get stuck with unused vaccines
or hurt by lawsuits. Congress passed liability protection in 2002, then
repealed it. New legislation is at square one.
Readiness.
Plans to deal with a bioterror attack — similar to those needed in a flu
crisis — are a patchwork, at best. Even if the government had enough vaccine
to go around, cities would need ways to get it, store it and vaccinate
people efficiently. HHS has acknowledged that, in an anthrax attack, no city
has a workable plan to get supplies to the public fast enough. That bodes
ill for any public health emergency.
Pandemics and hurricanes have all too much in common. Each is predictable.
Each strikes quickly. And each is exposing failures of leadership and
organization. But the scale is different. Left unaddressed, the flu threat
may one day justify the scariest of headlines.
Halloween came early to the Capitol yesterday, as disease experts lined up
to scare the dickens out of lawmakers in a "congressional briefing" on the
coming flu pandemic.
The elected representatives missed their briefing, because they were home
for their Columbus Day recess, trick-or-treating for campaign checks. But a
roomful of staffers, pharmaceutical lobbyists and reporters toured a medical
house of horrors in the Hart Senate Office Building.
"This is a nation-busting event!" warned Tara O'Toole, CEO of the University
of Pittsburgh Medical Center's Center for Biosecurity. Speculating that 40
million Americans could die -- that's about one in eight -- she warned: "We
must act now."
"We and the entire world remain unprepared for what could arguably be the
most horrific disaster in modern history," inveighed Gregory A. Poland of
the Mayo Clinic and the Infectious Diseases Society of America. Somebody in
the audience sneezed, and Poland added: "The clock is ticking. We've been
warned."
It was hard to top that, but Constance Hanna, an occupational health
specialist, tried. "Let me paint you a little picture," she began. "Twenty
to 30 percent of your employees don't show up to work . . . schools are
closed . . . transportation systems are curtailed or shut down . . .
Critical infrastructure will or may fail: food, water, power, gas,
electricity."
"This picture," Hanna added, redundantly, "is pretty scary."
Even before the start, there wasn't much doubt about the answer posed in the
briefing's title, "Are we prepared for a Pandemic Flu Outbreak?" After
Hurricane Katrina, the answer to any question beginning with "are we
prepared" is an emphatic negative.
Attendees were greeted by an ominous poster of a man wearing a mask,
followed by welcoming tables piled with boxed lunches of cookies, chips and
sandwiches (smoked chicken -- at an avian flu briefing?). Those who did not
eat quickly would soon lose their appetites.
O'Toole, a medical doctor and public health specialist, said the bird flu of
concern is potentially worse than the 1918 pandemic that killed 675,000
Americans. And this time, she said, the mortality rate might not be 1 or 2
percent, but 40 or 50 percent. "You can do the arithmetic," O'Toole said.
For those keeping score, that's 40 million to 42.5 million dead. And
O'Toole's ghost story was not over.
"Suppose the pandemic comes next year," she said, and "a year and a half
from now, next winter, you're thinking about today. You were one of the
lucky ones: You got sick but you recovered and now you have immunity against
the pandemic strain. But one out of four Americans was infected, one of four
people sitting here today, and half of them died." Some people looked
around: There were about 200 in the room, so about 50 would get the bug, and
25 would die.
On the positive side, this level of mortality would have left enough chicken
sandwiches for everybody at the event.
Public-health types are always warning of doom and asking for more
government spending, $5 billion to $16 billion in this case. It's possible
that the virus will not learn to spread easily among humans, and it's likely
the virus will grow less lethal if it does. But the medical experts,
well-credentialed all, were alarmingly unified in their alarm. Their dire
warnings proved gripping enough to silence the usual back-of-the-room
chatter.
"This is real," said Shelley A. Hearne, executive director of the Trust for
America's Health, as she kicked off the event.
"Death rates approaching this order of magnitude are unprecedented for any
epidemic disease," contributed O'Toole.
This was difficult to top, but Poland tried. "I want to emphasize the
certainty that a pandemic will occur," he began. "When this happens, time
will be described, for those left living, as before and after the pandemic."
"The key to our survival, in my opinion, and to the continuity of
government," he said, is vaccination. And "we do not have a licensed or
approved vaccine."
Up next, Isaac Weisfuse, the New York City deputy health commissioner,
provided some logistical fears to add to the medical ones. "We'll be
inundated," he said. "We have no [antiviral] Tamiflu. We have no vaccine. .
. . There is no cache of respirators."
There was little left unsaid for speakers lower in the program. Jeffrey Levi
of George Washington University prophesied a panic of "millions and millions
of people" trying to get antiviral prescriptions filled. Hanna struggled for
superlatives: "We haven't even begun to conceive of, to understand, to
comprehend what that may mean for our workplace."
That was ominous, but it did not approach O'Toole's apocalyptic fervor:
"uniquely virulent . . . hospitals will be quickly overwhelmed . . . this
time of peril . . . quarantine is not going to work."
O'Toole's speech quieted the room. People stopped munching on their smoked
chicken. Moderator Hearne took the microphone: "And have a good day, right?"
We're planning antivirals, vaccine, and partnerships here and abroad.
By Michael Leavitt
USA
Today
Commentary
Thursday, October 13, 2005; Page 11A
A
flu pandemic is caused when a virulent new influenza virus emerges that can
be transmitted person to person. Today, we know there's a possibility that
just such a virus may be evolving. The H5N1 strain of bird flu in Asia has
spread to more than 10 countries by migratory birds. Contact with infected
poultry has sickened more than 100 people, killing half of them. This is a
new flu strain, and there is no natural immunity.
Though there is no evidence yet that H5N1 will be the strain of flu that
causes a pandemic, we must be prepared for it and other potential infectious
diseases that could spread rapidly around the world, putting millions of
people in every nation at risk. The death toll could be staggering.
The United States is preparing for, and striving to limit the effects of, an
influenza pandemic. We are developing stockpiles of antivirals, which
mitigate the effects of the flu. We have rapidly developed a human vaccine
against the H5N1 virus, which is still in clinical trials. We have increased
investments to develop the next generation of vaccine manufacturing
technology, and we have met with vaccine manufacturers to discuss increasing
the number of domestic vaccine manufacturers and their production capacity.
A
human outbreak anywhere means risk everywhere. President Bush has launched
an international partnership to increase surveillance as the first line of
defense in stopping the disease before it spreads. Should a pandemic occur,
the United States will pursue a prevention or containment strategy where
feasible, acting in concert with the World Health Organization and other
nations.
This is a challenge that requires a high level of state and local
preparedness because, unlike other disasters, it could affect thousands of
cities and towns across the USA all at the same time. The federal government
must be an active partner with states, local communities, workplaces,
schools and homes in preparedness activities.
Through these and other efforts, we can minimize the health effects of a
pandemic and reduce suffering and loss for our nation and the world.
Michael Leavitt is secretary of the Department of Health and Human Services.
