DHMH Daily News Clippings

Thursday, October 13, 2005
News Clipping Archives
Taking science to next stage (Baltimore Sun)
Flu vaccine plant in city proposed (Baltimore Sun)
14 Catch Pneumonia at Frederick School (Washington Post)
Report Finds Toxic Chemicals in Common Baby Products (Capital News Service)
Agencies inform seniors of new drug plans (Baltimore Sun)
Annapolis woman faces battle on aiding feral cats (Annapolis Capital)
Patient suing Carroll Hospital Center (Baltimore Sun)
Hopkins project to plug computers into disease research (Baltimore Business Journal)
Checkups at the Drugstore (Washington Post)
Schools cut fat from lunch staples (Frederick Gazette)
Troubled Maker of Flu Shots Wins Approval of First Batch (New York Times)
Health experts take issue with flu toll estimate (Baltimore Sun)
Asian Shots Are Proposed as Flu Fighter (New York Times)
EU says bird flu found in Turkey is deadly strain (USA Today)
Cooling Unresponsive Newborns May Reduce the Risk of Death (Wall Street Journal)
Grants' Aim Is to Speed Medical Advances (Washington Post)
F.D.A. to Weigh At-Home Testing for AIDS Virus (New York Times)
Decision on Plan B Called Very Unusual (Washington Post)
New Vaccines Can Cut Whooping Cough Cases In Teenagers and Adults (Wall Street Journal)
Pfizer wins Lipitor UK ruling (Daily Record)
Treated for Illness, Then Lost in Labyrinth of Bills (New York Times)
Whistle-blower case goes to high court (Baltimore Sun)
Helping seniors cope (Hagerstown Herald-Mail Editorial)
Flu fighters gaining little (USA Today Editorial)
Capitol Hill Flu Briefing Was No Trick, and No Treat (Washington Post Commentary)
U.S. preparation focused (USA Today Commentary)

Taking science to next stage
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."
Copyright © 2005, The Baltimore Sun

Flu vaccine plant in city proposed
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.
Copyright © 2005, The Baltimore Sun

14 Catch Pneumonia at Frederick School
Washington Post
Thursday, October 13, 2005; B03
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.
© 2005 The Washington Post Company

Report Finds Toxic Chemicals in Common Baby Products
By Mari Perry
Capital News Service
Thursday, October 13, 2005
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.
Copyright © 2005 University of Maryland Philip Merrill College of Journalism

Agencies inform seniors of new drug plans
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.
Copyright © 2005, The Baltimore Sun

Annapolis woman faces battle on aiding feral cats
By Pete Holley, Staff Writer
Annapolis Capital
Wednesday, October 12, 2005
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.
Copyright © 2005 The Capital, Annapolis, Md.

Patient suing Carroll Hospital Center
By Jennifer McMenamin
Baltimore Sun reporter
Thursday, October 13, 2005
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."
Copyright © 2005, The Baltimore Sun

Hopkins project to plug computers into disease research
Alan Zibel
Baltimore Business Journal Staff
Thursday, October 13, 2005
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.
© 2005 American City Business Journals Inc.

Checkups at the Drugstore
Nurses Staffing Health Convenience Facilities
By Bill Brubaker
Washington Post Staff Writer
Thursday, October 13, 2005; D04
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.
© 2005 The Washington Post Company

Schools cut fat from lunch staples
By Keith L. Martin
Frederick Gazette
Thursday, October 13, 2005
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.”
Copyright © 2005 The Gazette

Troubled Maker of Flu Shots Wins Approval of First Batch
By Gardiner Harris
New York Times
Thursday, October 13, 2005
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.
Copyright 2005 The New York Times Company

Health experts take issue with flu toll estimate
Los Angeles Times
Baltimore Sun
Thursday, October 13, 2005
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.
Copyright © 2005, The Baltimore Sun

Asian Shots Are Proposed as Flu Fighter
By Donald G. McNeil Jr.
New York Times
Thursday, October 13, 2005
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.
Copyright 2005 The New York Times Company

EU says bird flu found in Turkey is deadly strain
Associated Press
USA Today
Thursday, October 13, 2005
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.
Copyright 2005 The Associated Press

Cooling Unresponsive Newborns May Reduce the Risk of Death
By Sylvia Pagan Westphal, Staff Reporter
Wall Street Journal
Thursday, October 13, 2005; Page D3
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.
Copyright 2005 Dow Jones & Company, Inc.

Grants' Aim Is to Speed Medical Advances
By Rob Stein
Washington Post Staff Writer
Thursday, October 13, 2005; A21
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.
© 2005 The Washington Post Company

F.D.A. to Weigh At-Home Testing for AIDS Virus
By Gardiner Harris
New York Times
Thursday, October 13, 2005
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-½ 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.
Copyright 2005 The New York Times Company

Decision on Plan B Called Very Unusual
By Marc Kaufman
Washington Post Staff Writer
Thursday, October 13, 2005; A09
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.
© 2005 The Washington Post Company

New Vaccines Can Cut Whooping Cough Cases In Teenagers and Adults
Associated Press
Wall Street Journal
Thursday, October 13, 2005
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.
Copyright 2005 Dow Jones & Company, Inc.

Pfizer wins Lipitor UK ruling
By Megan Murphy and Nicole Ostrow, Bloomberg
Daily Record
Thursday, October 13, 2005
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.
Copyright 2005 © The Daily Record

Treated for Illness, Then Lost in Labyrinth of Bills
By Katie Hafner
New York Times
Thursday, October 13, 2005
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."
Copyright 2005 The New York Times Company

Whistle-blower case goes to high court
Public employees' free speech subject of ruling
By David G. Savage
Baltimore Sun
Thursday, October 13, 2005
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.
David G. Savage writes for the Los Angeles Times.
Copyright © 2005, The Baltimore Sun

Helping seniors cope
Hagerstown Herald-Mail Editorial
Thursday, October 13, 2005
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.
Copyright The Herald-Mail ONLINE

Flu fighters gaining little
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.
Copyright 2005 USA Today

Capitol Hill Flu Briefing Was No Trick, and No Treat
By Dana Milbank
Washington Post Commentary
Thursday, October 13, 2005; A02
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?"
© 2005 The Washington Post Company

U.S. preparation focused
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.
Copyright 2005 USA Today