Hospital fined for wrongside surgery
Tue, 27 Nov 2007 04:04:18 GMT
PROVIDENCE, R.I. - Rhode Island Hospital was fined $50,000 and reprimanded by the state Department of Health Monday after its third instance this year of a doctor performing brain surgery in the wrong side of a patient's head.
"We are extremely concerned about this continuing pattern," Director of Health David R. Gifford said in a written statement. "While the hospital has made improvements in the operating room, they have not extended these changes to the rest of the hospital."
The most recent case happened Friday when, according to the health department, the chief resident started brain surgery on the wrong side of an 82-year-old patient's head. The patient was OK, the health department and hospital said.
In February, a different doctor performed neurosurgery on the wrong side of another patient's head, said Andrea Bagnall-Degos, a health department spokeswoman. That patient was also OK, she said.
But in August, a patient died a few weeks after a third doctor performed brain surgery on the wrong side of his head. That surgery prompted the state to order the hospital to take a series of steps to ensure such a mistake would not happen again, including an independent review of its neurosurgery practices and better verification from doctors of surgery plans.
In a written statement, Rhode Island Hospital said it was working with the Department of Health to minimize the risk of medical errors.
"We are committed to continuing to evaluate and implement changes to our policies to help ensure these human errors are caught before they reach the patient," the statement read.
The hospital said it was re-evaluating its training and policies, providing more oversight, giving nursing staff the power to ensure procedures are followed, and other steps.
In addition to the fine, the state ordered the hospital to develop a neurosurgery checklist that includes information about the location of the surgery and a patient's medical history, and to put in place a plan to train staff on the new checklist.
The Board of Medical Licensure and Discipline and Board of Nursing is also investigating.
Atlanta hospital in grave condition
Tue, 27 Nov 2007 04:10:07 GMT
By ERRIN HAINES, Associated Press Writer
ATLANTA - For generations, Grady Memorial Hospital has treated the poorest of the poor, victims of stabbings and shootings, and motorists grievously injured in Atlanta's murderous rush-hour traffic.
Now, Grady itself is in grave condition.
Staggering under a deficit projected at $55 million, the city's only public hospital could close at the end of the year, leaving Atlanta without a major trauma center and foisting thousands of poor people onto emergency rooms at other hospitals for their routine medical care.
"I don't have the words to describe the onslaught of health care needs that will hit the region if Grady were to close," said Dr. Katherine Heilpern, chief of emergency medicine at the Emory University medical school, which uses Grady as a teaching hospital and supplies many of its physicians. "This is a huge deal. We may literally have people's lives at stake if the Grady Health System fails and spirals down into financial insolvency."
Grady Memorial Hospital's board of trustees on Monday unanimously agreed to establish a nonprofit governing board intended to attract $300 million in immediate and long-term funding from the city's business, philanthropic and government communities as well as from the state.
Dozens of activists, doctors, clergy members, lawmakers and citizens packed an auditorium across from Grady and demanded to be heard before the board voted.
"Y'all ought to be ready to stay here all night," said state Sen. Vincent Fort, who was involved in a scuffle with hospital security guards shortly before the meeting. "The fight ain't over. If some of us have to go to jail, so be it."
Founded in 1892, Grady has struggled financially for years. But now it has reached a crisis because of rising health care costs, dwindling government aid, a lack of paying customers and years of neglect — a situation not uncommon among urban hospitals like Grady that primarily serve the needy.
In addition to losing money on patient care, Grady needs an estimated $300 million to repair and modernize its buildings and acquire new equipment such as CT scanners and an up-to-date computer system.
The loss of Grady would be unconscionable to many political and civic leaders in this booming metropolitan area of 5 million people. The overwhelming majority of the 900,000 patients treated at Grady each year are poor and black, and the institution is considered a vital part of Atlanta's black community.
But some fear that after the switch to a nonprofit governing board the hospital will be less committed to the poor, and that the board will go from mostly black to mostly white. Grady has been run by a governing board whose members are appointed by politicians in Fulton and Dekalb counties.
Fort, a black Democrat from Atlanta, said earlier that Grady is "absolutely critical" to the city's black poor. And he charged that Atlanta's "white power structure" — including the business leaders and politicians who are pushing for the nonprofit board — is trying to orchestrate a takeover.
"To the extent that you have African American doctors, nurses and other professionals operating a big-city hospital and taking care of black people, that is a source of pride in the black community," Fort said. "So there is a great deal of skepticism that the Chamber of Commerce is interested in Grady. There are some of us who believe that is a self-interest."
With 953 beds and 5,000 employees, Grady is an anchor of Atlanta's downtown and accepts all patients, without regard to their ability to pay.
Only 7 percent of Grady's patients have private insurance, and 75 percent are on Medicaid. Because they lack insurance and have no family doctor, many go to Grady's emergency room even when they don't have an emergency. The ER ends up treating sore throats and other ordinary aches and pains.
Besides Atlanta's poor, Grady's patients include tourists passing through on their way south to Walt Disney World and victims of auto accidents, since Grady is the only hospital in a 100-mile radius of Atlanta that has a Level 1 trauma center, capable of treating the most serious injuries.
Grady played a critical role after the bombing at the 1996 Olympics blocks away. And in March, when a bus carrying a college baseball team from Ohio plunged off an overpass, 19 students and coaches were rushed to Grady.
"Quite frankly, that would've overwhelmed any other system in the city," Heilpern said. "That was sort of all in a day's work for us."
Grady also has the state's only poison control center, obstetrics intensive care unit and comprehensive sickle cell center. And the city's emergency command center for handling plane crashes and terrorist attacks is based at Grady.
If Grady were to close, poor people would probably swamp other hospitals' ERs with everything from ordinary colds to genuine medical emergencies.
"It will be a sad day for Atlanta if Grady closes. If people realized the benefits Grady provides, closure would not be on the table," said Dr. Marsha Regenstein, a health policy professor at George Washington University in the nation's capital.
Doctors, activists, lawmakers, business leaders and the hospital leadership are scrambling to find a fix for Grady, which gets most of its funding from Medicare, Medicaid and Fulton and Dekalb counties.
In July, a 17-member task force of business leaders recommended the shift to a nonprofit board. Some of Atlanta's major corporations have said they would contribute to Grady if it were run by a nonprofit board because it would manage the hospital more efficiently.
Other public hospitals that have been in distress in recent years include D.C. General Hospital in Washington, which in 2001 stopped taking inpatients, and Martin Luther King Jr.-Charles Drew Hospital, which was built in Los Angeles after the 1965 Watts riots. The hospital lost its government accreditation last summer because of shoddy care and closed its trauma center.
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On the Net:
Grady Health System: http://www.gradyhealthsystem.org
Rotary Gates give funds to fight polio
Mon, 26 Nov 2007 23:18:22 GMT
By MARIA CHENG, AP Medical Writer
LONDON - The global campaign to wipe out polio is getting a $200 million donation from Rotary International and the Bill & Melinda Gates Foundation, at a time when some worry the effort will fail in the final stages.
Monday's announcement by both organizations came after nearly two decades of work against polio, an infectious disease that can paralyze and sometimes kill.
"This investment is precisely the catalyst we need as we intensify the push to finish polio," Dr. Margaret Chan, director-general of the World Health Organization, said in a statement.
Though polio incidence has been slashed by more than 99 percent worldwide since the eradication effort began in 1988, the virus remains entrenched in Afghanistan, India, Nigeria and Pakistan.
Two deadlines to eliminate polio have been missed: 2000 and 2005. More than $5 billion has been poured into the effort, and some experts worry that unless the job is finished soon, the world community's money and patience may run out.
"They're on a heroic task, but money is not the only problem," said Dr. Donald A. Henderson, who headed WHO's smallpox successful eradication campaign. "We've got to soldier on. We need more money. Look at all we've accomplished. But how do we get to the endpoint?"
Henderson and other experts worry that major obstacles to vaccinating children will be harder to overcome than filling a funding gap.
In countries like Pakistan, Afghanistan, Somalia and Congo, where there are armed conflicts and weak health services, it has been extremely difficult to reach the high vaccination levels needed to wipe out polio. And in India, the vaccine is less effective, due to poor sanitation and the fact that children are often infected with intestinal viruses.
Experts are also concerned about the use of the oral vaccine, which contains live polio virus. In rare instances, the virus can mutate into a dangerous form capable of causing the disease.
The donation from Rotary International and the Gates Foundation, to be paid over three years, will largely go to immunization campaigns, surveillance and public education.
"This amount of money can make quite a big difference," said Nicholas Grassly, of Imperial College, London, who advises WHO on polio issues. "We can build on the gains that have been made this year."
WHO reports significant progress against polio in India and Nigeria, where 85 percent of the world's polio cases occur. Last year at this time, Nigeria had 958 polio cases. This year, only 226 were reported.
Still, the $200 million falls short of the $650 million that WHO says will be needed by 2009. Eradicating polio will ultimately cost $1 billion more, said Dr. David Heymann, WHO's top polio official.
Halted gene therapy study to resume
Mon, 26 Nov 2007 23:09:03 GMT
By LINDSEY TANNER, AP Medical Writer
CHICAGO - A gene therapy study halted after an arthritis patient died will resume with one main change: participants won't get injections if they have signs of infections, the treatment's developer said Monday.
While an investigation indicated gene therapy injections didn't kill the patient, Targeted Genetics Corp. is being cautious in resuming the study of what it considers a potentially promising treatment for inflammatory arthritis.
Jolee Mohr had a slight fever — a sign of infection — when she received the last of two injections at a Springfield, Ill., clinic on July 2. She died three weeks later after doctors discovered a massive fungal infection and internal bleeding.
Targeted Genetics has chosen a "conservative" approach in resuming the experiment, chief executive officer H. Stewart Parker said in a telephone interview Monday. Of 127 total participants, 35 still need a second shot and will be told of Mohr's death when the study resumes, the company said.
Investigation participants included the company, the U.S. Food and Drug Administration and the University of Chicago Medical Center, where Mohr was transferred after she fell ill and where she died. Final results are to be discussed at a federal gene therapy committee meeting on Dec. 3 at the National Institutes of Health outside Washington.
Panelists at a previous NIH committee meeting in September had raised concerns about Mohr receiving the experimental treatment when she already had signs of illness.
Questions also had been raised about whether genetically engineered viruses injected into patients' joints as part of the experiment might spread throughout the body, causing illness.
But tests on Mohr found only trace amounts in tissues outside her joints, not enough to have contributed to her death, said Dr. Kyle Hogarth, a University of Chicago physician who treated Mohr after she fell ill.
Seattle-based Targeted Genetics believes arthritis medicine Mohr already was taking, which has been linked to an increased risk for fungal infections, likely played a role.
Hogarth said "it's great" that the study is resuming because the experimental treatment could be useful. But he also said troubling questions remain, including why participants will be allowed to continue taking arthritis medicine that could complicate efforts to prove that the gene treatment is safe.
Hogarth also noted that Mohr's own doctor recruited her for the study and also performed the experimental treatment, which he said raises ethical concerns. That's because patients tend to trust that their doctors are working in their behalf, and so Mohr could have mistakenly assumed he was recommending an already proven treatment.
Alan Milstein, an attorney for Mohr's husband, Robb, said the family still believes her death was avoidable.
The study involved injecting patients with trillions of genetically engineered viruses carrying a gene intended to help the body produce an inflammation-fighting protein.
The FDA halted the study after Mohr's death but last week told the company it could continue.
"We believe this is a vindication for the product and for the gene therapy field in general," Parker said.
While the study's first phase was to examine safety, there were early indications that the experimental treatment helped relieve pain for those with inflammatory arthritis, Parker said. Inflammatory arthritis includes rheumatoid arthritis and affects more than 2 million Americans.
____
Associated Press writer Carla K. Johnson contributed to this report.
____
On the Net:
NIH: http://www.nih.gov and http://bioethics.od.nih.gov
Targeted Genetics: http://www.targen.com
Study Kids will eat healthy school food
Mon, 26 Nov 2007 23:18:56 GMT
By STEVE KARNOWSKI, Associated Press Writer
MINNEAPOLIS - Maybe getting schoolchildren to eat healthy foods isn't a hopeless struggle. Bucking some common notions, a University of Minnesota study has found that school lunch sales don't decline when healthier meals are served, and that more nutritious lunches don't necessarily cost schools more to produce.
"The conventional wisdom that you can't serve healthier meals because kids won't eat them is false," said Benjamin Senauer, one of three economists who wrote the study.
Previous studies have concluded that students prefer fatty foods and that healthier meals cost more to make, the authors noted.
The study, which appears in the December issue of the Review of Agricultural Economics, analyzed five years of data for 330 Minnesota public school districts. It looked at compliance with federal standards for calories, nutrients and fats.
When the researchers crunched all the numbers they found that schools serving the healthiest lunches did not see a falloff in demand.
While serving better meals does entail higher labor costs, the study found, that's offset by lower costs for more nutritious foods such as fruits and vegetables compared with processed foods. However, many districts need to upgrade their kitchens and train their staff to prepare these foods, the researchers said.
The study's conclusions rang true for Jean Ronnei, director of nutrition services for St. Paul Public Schools, which serves more than 46,000 meals daily. The district was held up by the authors as a model for others.
Ronnei said the percentage of St. Paul kids eating school lunches has increased in recent years at the same time the district has been offering more fruits and vegetables.
"That doesn't mean we don't have a hot dog on our menu. We do. ... In our case it's a turkey low-fat hot dog," she said.
Margo Wootan, director of nutrition policy at the nonprofit Center for Science in the Public Interest in Washington, said she was pleased to see evidence that schools can offer nutritious meals kids will eat without higher costs.
"I think people underestimate the willingness of kids to eat healthier foods," she said.
The study also pointed out that school districts are allowed to charge their lunch programs for indirect costs such as electricity or janitorial services for their cafeterias. The authors said that can be abused by cash-strapped districts charging their lunch programs high overhead; they recommended tighter limits on those charges.
Dr. Sandra Hassink of Wilmington, Del., a member of the American Academy of Pediatrics' Obesity Task Force, said that was an important finding. She said money allocated for nutritional programs should be spent on nutrition.
Alice Jo Rainville, a professor of nutrition and dietetics at Eastern Michigan University, noted that school nutrition programs have improved because of federal policy changes enacted in 2004, the last year included in the study.
Rainville said results in other states might not match those in Minnesota, but Senauer said he believes the situation is similar across the country.
"Everything we've done here, there's good reason to believe it's happening nationally," he said.
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On the Net:
National School Lunch Program: http://www.fns.usda.gov/cnd/lunch
School Nutrition Association: http://www.schoolnutrition.org/
Alzheimer drugs don39t delay dementia onset study
Tue, 27 Nov 2007 01:08:58 GMT
By Ben Hirschler
LONDON -
Giving Alzheimer's drugs to people with
early memory problems does not seem to delay the onset of the
disease, researchers said on Tuesday.
Three main drugs -- Aricept, or donepezil; Exelon, or
rivastigmine; and Reminyl, or galantamine -- are currently
approved for use in mild-to-moderate Alzheimer's disease.
They are also often prescribed on a so-called &;off-label&;
basis to people with pre-dementia.
But doctors are divided over their effectiveness, leading
to differing rates of use and bitter arguments over patient
access to treatment, notably in Britain where a dispute over
their cost-effectiveness has led to legal clashes.
Some experts and patient groups have called for such
anti-cholinesterase drugs to be given to people with mild
cognitive impairment -- a condition where people have
memory problems that are more severe than those normally seen
in others of their age.
People with MCI are thought to be at high risk of
developing Alzheimer's or dementia.
Italian researchers, however, found that in none of six
clinical trials they examined did using the drugs significantly
reduce the rate of progression from MCI to dementia.
Accurate assessment of the effect of anti-cholinesterase
medicines was muddied by the lack of a precise definition for
MCI, Roberto Raschetti and colleagues at the National Centre
for Epidemiology, Surveillance and Health Promotion in Rome
reported in the online journal PLoS Medicine.
Their findings may prompt a rethink among doctors who are
currently using anti-cholinesterase drugs off-label in MCI.
Off-label use refers to the common practice of prescribing
drugs for uses for which they are not officially approved.
In Italy, an estimated 27 percent of patients diagnosed
with MCI are given Alzheimer's drugs off-label and Raschetti
said it was likely the situation was similar in other
countries.
He argued more clinical trials were needed, using a single
agreed definition of MCI, before there could be any
justification for doctors to use the drugs in pre-dementia
cases, especially as the drugs can have harmful side effects.
Aricept is marketed by Japan's Eisai Co Ltd and Pfizer Inc,
while Novartis AG sells Exelon. Reminyl is sold by Shire Plc
and also by Johnson & Johnson under the brand name Razadyne.
A row over who should get these drugs ended up in court in
London earlier this year after Britain's National Institute for
Health and Clinical Excellence said they should not be given to
newly diagnosed patients with mild Alzheimer's disease.
Drugmakers claimed the agency's cost-effectiveness
calculations were flawed but the court backed the restrictions
in a ruling handed down in August.
