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brdgt
Drug-Dose Gender Gap
RONI CARYN RABIN, JANUARY 28, 2013, The New York Times
Most sleeping pills are designed to knock you out for eight hours. When the Food and Drug Administration was evaluating a new short-acting pill for people to take when they wake up in the middle of the night, agency scientists wanted to know how much of the drug would still be in users' systems come morning.
Blood tests uncovered a gender gap: Men metabolized the drug, Intermezzo, faster than women. Ultimately the F.D.A. approved a 3.5 milligram pill for men, and a 1.75 milligram pill for women.
The active ingredient in Intermezzo, zolpidem, is used in many other sleeping aids, including Ambien. But it wasn't until earlier this month that the F.D.A. reduced doses of Ambien for women by half.
Sleeping pills are hardly the only medications that may have unexpected, even dangerous, effects in women. Studies have shown that women respond differently than men to many drugs, from aspirin to anesthesia. Researchers are only beginning to understand the scope of the issue, but many believe that as a result, women experience a disproportionate share of adverse, often more severe, side effects.
"This is not just about Ambien - that's just the tip of the iceberg," said Dr. Janine Clayton, director for the Office of Research on Women's Health at the National Institutes of Health. "There are a lot of sex differences for a lot of drugs, some of which are well known and some that are not well recognized."
Until 1993, women of childbearing age were routinely excluded from trials of new drugs. When the F.D.A. lifted the ban that year, agency researchers noted that because landmark studies on aspirin in heart disease and stroke had not included women, the scientific community was left "with doubts about whether aspirin was, in fact, effective in women for these indications."
Because so many drugs were tested mostly or exclusively in men, scientists may know little of their effects on women until they reach the market. A Government Accountability Office study found that 8 of 10 drugs removed from the market from 1997 through 2000 posed greater health risks to women.
For example, Seldane, an antihistamine, and the gastrointestinal drug Propulsid both triggered a potentially fatal heart arrhythmia more often in women than in men. Many drugs still on the market cause this arrhythmia more often in women, including antibiotics, antipsychotics, anti-malarial drugs and cholesterol-lowering drugs, Dr. Clayton said. Women also tend to use more medications than men.
The sex differences cut both ways. Some drugs, like the high blood pressure drug Verapamil and the antibiotic erythromycin, appear to be more effective in women. On the other hand, women tend to wake up from anesthesia faster than men and are more likely to experience side effects from anesthetic drugs, according to the Society for Women's Health Research.
Women also react differently to alcohol, tobacco and cocaine, studies have found.
It's not just because women tend to be smaller than men. Women metabolize drugs differently because they have a higher percentage of body fat and experience hormonal fluctuations and the monthly menstrual cycle. "Some drugs are more water-based and like to hang out in the blood, and some like to hang out in the fat tissue," said Wesley Lindsey, assistant professor of pharmacy practice at Auburn University, who is a co-author of a paper on sex-based differences in drug activity.
"If the drug is lipophilic" - attracted to fat cells - "it will move into those tissues and hang around for longer," Dr. Lindsey added. "The body won't clear it as quickly, and you'll see effects longer."
There are also sex differences in liver metabolism, kidney function and certain gastric enzymes. Oral contraceptives, menopause and post-menopausal hormone treatment further complicate the picture. Some studies suggest, for example, that when estrogen levels are low, women may need higher doses of drugs called angiotensin receptor blockers to lower blood pressure, because they have higher levels of proteins that cause the blood vessels to constrict, said Kathryn Sandberg, director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown.
Many researchers say data on these sex differences must be gathered at the very beginning of a drug's development - even before trials on human subjects begin.
"The path to a new drug starts with the basic science - you study an animal model of the disease, and that's where you discover a drug target," Dr. Sandberg said. "But 90 percent of researchers are still studying male animal models of the disease."
There have been improvements. In an interview, Dr. Robert Temple, with the Center for Drug Evaluation and Research at the F.D.A., said the agency's new guidelines in 1993 called for studies of sex differences at the earliest stages of drug development, as well as for analysis of clinical trial data by sex.
He said early research on an irritable bowel syndrome drug, alosetron (Lotronex), suggested it would not be effective in men. As a result, only women were included in clinical trials, and it was approved only for women. (Its use is restricted now because of serious side effects.)
But some scientists say drug metabolism studies with only 10 or 15 subjects are too small to pick up sex differences. Even though more women participate in clinical trials than in the past, they are still underrepresented in trials for heart and kidney disease, according to one recent analysis, and even in cancer trials.
"The big problem is we're not quite sure how much difference this makes," Dr. Lindsey said. "We just don't have a good handle on it."
Link to African Ebola Found in Bats Suggests Virus Is More Widespread
By DONALD G. McNEIL Jr., January 28, 2013, The New York Times
For the first time, scientists have found evidence of the African Ebola virus in Asian fruit bats, suggesting that the virus is far more widespread around the world than had been previously known.
That does not mean that outbreaks of hemorrhagic fever are inevitable, said Kevin J. Olival, leader of the bat-hunting team at EcoHealth Alliance. But the possibility exists: bats are believed to drink out of jars attached to trees to collect tasty date palm sap, and fatal outbreaks in Bangladesh of Nipah virus, which is not related to Ebola, have been blamed on fresh sap contaminated with bat saliva, urine or feces.
Palm sap gatherers should be encouraged to put bamboo covers on their collecting jars to keep bats out, Dr. Olival said.
For the study, published this month in Emerging Infectious Diseases, his team caught 276 bats in four Bangladesh districts.
“These bats roost in caves, but there are very few caves in Bangladesh, so we put up mist nets outside old ruins that looked like something out of ‘Indiana Jones,’ ” he said. “In the evenings, they would come out to forage.” The team would untangle the bats, draw blood and take saliva, urine and fecal samples, and release them.
Five of them — all from the Rousettus leschenaultia species — reacted to tests for antibodies to Zaire Ebola virus. The researchers did not find any virus itself, so it was not possible to do genetic sequencing and see exactly how close the match to the African strain was.
Although closely related species of fruit bats are found in Africa, India and China, their territories do not overlap and these bats don’t migrate long distances, Dr. Olival said, so it was likely the virus had been in a bat ancestor species for millenniums. A related virus, Ebola Reston, which is not known to sicken humans, has been found in Philippines fruit bats, and an “Ebola-like” virus has been found in insect-eating bats in Spain. But the match in Bangladesh was closest to Zaire Ebola.
Ebola was at first thought to be a gorilla virus, because human outbreaks began after people ate the bodies of dead gorillas. But scientists believe that bats are the natural reservoir and that primates may get infected by eating fruit that bats have drooled or defecated on.
An Oil Boom Takes a Toll on Health Care
By JOHN ELIGON, January 27, 2013, The New York Times
WATFORD CITY, N.D. — The patients come with burns from hot water, with hands and fingers crushed by steel tongs, with injuries from chains that have whipsawed them off their feet. Ambulances carry mangled, bloodied bodies from accidents on roads packed with trucks and heavy-footed drivers.
The furious pace of oil exploration that has made North Dakota one of the healthiest economies in the country has had the opposite effect on the region’s health care providers. Swamped by uninsured laborers flocking to dangerous jobs, medical facilities in the area are sinking under skyrocketing debt, a flood of gruesome injuries and bloated business costs from the inflated economy.
The problems have been acute at McKenzie County Hospital here. Largely because of unpaid bills, the hospital’s debt has climbed more than 2,000 percent over the past four years to $1.2 million, according to Daniel Kelly, the hospital’s chief executive. Just three years ago, Mr. Kelly added, the hospital averaged 100 emergency room visits per month; last year, that average shot up to 400.
Over all, ambulance calls in the region increased by about 59 percent from 2006 to 2011, according to Thomas R. Nehring, the director of emergency medical services for the North Dakota Health Department. The number of traumatic injuries reported in the oil patch increased 200 percent from 2007 through the first half of last year, he said.
The 12 medical facilities in western North Dakota saw their combined debt rise by 46 percent over the course of the 2011 and 2012 fiscal years, according to Darrold Bertsch, the president of the state’s Rural Health Association.
Hospitals cannot simply refuse to treat people or raise their rates. Expenses at those 12 facilities increased by 15 percent, Mr. Bertsch added, and nine of them experienced operating losses. Costs are rising to hire and retain service staff members, as hospitals compete with fast food restaurants that pay wages of about $20 an hour.
“Plain and simple, those kinds of things are not sustainable,” he said.
Many of the new patients are transient men without health insurance or a permanent address in the area. In one of the biggest drivers of the hospital debt, patients give inaccurate contact information; when the time comes to collect payment, the patients cannot be found. McKenzie County Hospital has invested in new software that will help verify the information patients give on the spot.
Mr. Kelly has pushed for the state, which has a surplus of more than $1 billion, to allocate money intended for the oil region specifically to health care facilities in the area. He has also asked for the state to grant low-interest loans so hospitals can borrow money for facility improvements and for the governor to convene a task force to study health care issues in the oil patch.
Aides to Gov. Jack Dalrymple say he is taking steps to bolster medical training in the state, proposing to spend $68 million on a new medical school building at the University of North Dakota and $6 million to expand the nursing program at Lake Region State College. Mr. Dalrymple, a Republican, has also increased Medicaid financing for the state’s rural hospitals.
“Health care is certainly one of those areas that was targeted early on as we’ve seen growth out west,” said Jeffrey L. Zent, a spokesman for the governor.
Public utility numbers suggest that the population of Watford City has more than quadrupled to 6,500 over the past two years, Mr. Kelly said. In nearby Williston, considered the heart of the oil boom, the population, including temporary workers, has swelled to 25,000 to 33,000 from fewer than 15,000 in 2010, according to a study by North Dakota State University.
The huge population growth has produced new communities virtually overnight, creating logistical problems that affect the quality of medical care.
After a recent emergency call, Kelly Weathers, who has worked as a paramedic in the region for nearly 25 years, drove in circles with his team for about 15 minutes, searching for the address where they had been sent to treat a man who had hurt his back falling off a piece of equipment. But they could not find the street because a sign had not yet been erected. Eventually, a colleague of the injured man met the ambulance at the highway and escorted them to the site.
Mr. Weathers, who works for the Mountrail County Health Center in Stanley, said that in the past, “all the volunteers, they didn’t go by street signs.”
“It was like, ‘The corner store, third house to the north of that,’ ” he said. “So now, if you give them ‘62nd Avenue,’ they go, ‘Where’s that at?’ ”
Charles Quinn, 43, of Mississippi, has been working in the region for eight months repairing 18-wheelers. He said his job has its dangers because he often works under the trucks while they are running.
“It’s all kind of dangerous,” he said of the jobs in the oil patch. “There’s a lot more accidents around you because you got more people around you working.”
The cramped housing camps where many oil workers live can add to health issues. On a recent afternoon at McKenzie County Hospital, a man limped into the emergency room complaining about a dry, red patch of skin on his leg. Dr. Gary Ramage, the hospital’s sole full-time physician, said it was a bite from a brown recluse spider, which had most likely nested under the trailer where the man lives.
Since the oil industry started growing rapidly in the region, Dr. Ramage said, he has had to treat many more sexually transmitted diseases. Chlamydia rates in McKenzie County roughly doubled from 2010 to 2011.
With little money to spend, hospitals are struggling to finance sorely needed improvements and hire additional medical providers. McKenzie, which is six decades old, is a one-story brick building and has one room for emergencies. (A makeshift second emergency room was created from one of the inpatient rooms.) In a building across the street that houses a clinic, a narrow hallway with dark carpet is crowded with file drawers lining the walls.
Hospital executives are hoping to get the local government to approve a 1-cent sales tax increase so they can build a $55 million medical facility that would triple the size of the clinic, expand the emergency room, maintain the 24-bed hospital and increase space for other outpatient services like physical therapy. They have also spent the past year trying to hire two new doctors. Recruiting medical professionals to the area has long been a problem.
“Let’s be honest,” Mr. Kelly said. “People think they have to move to Siberia if they move to North Dakota.”
But for now, Dr. Ramage, a gregarious Canadian who has worked here for 18 years, is left shouldering much of the load. Before the oil boom started a few years back, Dr. Ramage covered both the clinic and the emergency room. Now he mostly works at the clinic, while the hospital hires roving physicians to cover the emergency room. He is well known in the community, and people call him at home when they are sick. But now, he does not know many of the patients he sees.
“My work is no longer small-town work,” he said. “My work has now been transformed from that of a small family practitioner to basically an E.R. doc.”
RONI CARYN RABIN, JANUARY 28, 2013, The New York Times
Most sleeping pills are designed to knock you out for eight hours. When the Food and Drug Administration was evaluating a new short-acting pill for people to take when they wake up in the middle of the night, agency scientists wanted to know how much of the drug would still be in users' systems come morning.
Blood tests uncovered a gender gap: Men metabolized the drug, Intermezzo, faster than women. Ultimately the F.D.A. approved a 3.5 milligram pill for men, and a 1.75 milligram pill for women.
The active ingredient in Intermezzo, zolpidem, is used in many other sleeping aids, including Ambien. But it wasn't until earlier this month that the F.D.A. reduced doses of Ambien for women by half.
Sleeping pills are hardly the only medications that may have unexpected, even dangerous, effects in women. Studies have shown that women respond differently than men to many drugs, from aspirin to anesthesia. Researchers are only beginning to understand the scope of the issue, but many believe that as a result, women experience a disproportionate share of adverse, often more severe, side effects.
"This is not just about Ambien - that's just the tip of the iceberg," said Dr. Janine Clayton, director for the Office of Research on Women's Health at the National Institutes of Health. "There are a lot of sex differences for a lot of drugs, some of which are well known and some that are not well recognized."
Until 1993, women of childbearing age were routinely excluded from trials of new drugs. When the F.D.A. lifted the ban that year, agency researchers noted that because landmark studies on aspirin in heart disease and stroke had not included women, the scientific community was left "with doubts about whether aspirin was, in fact, effective in women for these indications."
Because so many drugs were tested mostly or exclusively in men, scientists may know little of their effects on women until they reach the market. A Government Accountability Office study found that 8 of 10 drugs removed from the market from 1997 through 2000 posed greater health risks to women.
For example, Seldane, an antihistamine, and the gastrointestinal drug Propulsid both triggered a potentially fatal heart arrhythmia more often in women than in men. Many drugs still on the market cause this arrhythmia more often in women, including antibiotics, antipsychotics, anti-malarial drugs and cholesterol-lowering drugs, Dr. Clayton said. Women also tend to use more medications than men.
The sex differences cut both ways. Some drugs, like the high blood pressure drug Verapamil and the antibiotic erythromycin, appear to be more effective in women. On the other hand, women tend to wake up from anesthesia faster than men and are more likely to experience side effects from anesthetic drugs, according to the Society for Women's Health Research.
Women also react differently to alcohol, tobacco and cocaine, studies have found.
It's not just because women tend to be smaller than men. Women metabolize drugs differently because they have a higher percentage of body fat and experience hormonal fluctuations and the monthly menstrual cycle. "Some drugs are more water-based and like to hang out in the blood, and some like to hang out in the fat tissue," said Wesley Lindsey, assistant professor of pharmacy practice at Auburn University, who is a co-author of a paper on sex-based differences in drug activity.
"If the drug is lipophilic" - attracted to fat cells - "it will move into those tissues and hang around for longer," Dr. Lindsey added. "The body won't clear it as quickly, and you'll see effects longer."
There are also sex differences in liver metabolism, kidney function and certain gastric enzymes. Oral contraceptives, menopause and post-menopausal hormone treatment further complicate the picture. Some studies suggest, for example, that when estrogen levels are low, women may need higher doses of drugs called angiotensin receptor blockers to lower blood pressure, because they have higher levels of proteins that cause the blood vessels to constrict, said Kathryn Sandberg, director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown.
Many researchers say data on these sex differences must be gathered at the very beginning of a drug's development - even before trials on human subjects begin.
"The path to a new drug starts with the basic science - you study an animal model of the disease, and that's where you discover a drug target," Dr. Sandberg said. "But 90 percent of researchers are still studying male animal models of the disease."
There have been improvements. In an interview, Dr. Robert Temple, with the Center for Drug Evaluation and Research at the F.D.A., said the agency's new guidelines in 1993 called for studies of sex differences at the earliest stages of drug development, as well as for analysis of clinical trial data by sex.
He said early research on an irritable bowel syndrome drug, alosetron (Lotronex), suggested it would not be effective in men. As a result, only women were included in clinical trials, and it was approved only for women. (Its use is restricted now because of serious side effects.)
But some scientists say drug metabolism studies with only 10 or 15 subjects are too small to pick up sex differences. Even though more women participate in clinical trials than in the past, they are still underrepresented in trials for heart and kidney disease, according to one recent analysis, and even in cancer trials.
"The big problem is we're not quite sure how much difference this makes," Dr. Lindsey said. "We just don't have a good handle on it."
Link to African Ebola Found in Bats Suggests Virus Is More Widespread
By DONALD G. McNEIL Jr., January 28, 2013, The New York Times
For the first time, scientists have found evidence of the African Ebola virus in Asian fruit bats, suggesting that the virus is far more widespread around the world than had been previously known.
That does not mean that outbreaks of hemorrhagic fever are inevitable, said Kevin J. Olival, leader of the bat-hunting team at EcoHealth Alliance. But the possibility exists: bats are believed to drink out of jars attached to trees to collect tasty date palm sap, and fatal outbreaks in Bangladesh of Nipah virus, which is not related to Ebola, have been blamed on fresh sap contaminated with bat saliva, urine or feces.
Palm sap gatherers should be encouraged to put bamboo covers on their collecting jars to keep bats out, Dr. Olival said.
For the study, published this month in Emerging Infectious Diseases, his team caught 276 bats in four Bangladesh districts.
“These bats roost in caves, but there are very few caves in Bangladesh, so we put up mist nets outside old ruins that looked like something out of ‘Indiana Jones,’ ” he said. “In the evenings, they would come out to forage.” The team would untangle the bats, draw blood and take saliva, urine and fecal samples, and release them.
Five of them — all from the Rousettus leschenaultia species — reacted to tests for antibodies to Zaire Ebola virus. The researchers did not find any virus itself, so it was not possible to do genetic sequencing and see exactly how close the match to the African strain was.
Although closely related species of fruit bats are found in Africa, India and China, their territories do not overlap and these bats don’t migrate long distances, Dr. Olival said, so it was likely the virus had been in a bat ancestor species for millenniums. A related virus, Ebola Reston, which is not known to sicken humans, has been found in Philippines fruit bats, and an “Ebola-like” virus has been found in insect-eating bats in Spain. But the match in Bangladesh was closest to Zaire Ebola.
Ebola was at first thought to be a gorilla virus, because human outbreaks began after people ate the bodies of dead gorillas. But scientists believe that bats are the natural reservoir and that primates may get infected by eating fruit that bats have drooled or defecated on.
An Oil Boom Takes a Toll on Health Care
By JOHN ELIGON, January 27, 2013, The New York Times
WATFORD CITY, N.D. — The patients come with burns from hot water, with hands and fingers crushed by steel tongs, with injuries from chains that have whipsawed them off their feet. Ambulances carry mangled, bloodied bodies from accidents on roads packed with trucks and heavy-footed drivers.
The furious pace of oil exploration that has made North Dakota one of the healthiest economies in the country has had the opposite effect on the region’s health care providers. Swamped by uninsured laborers flocking to dangerous jobs, medical facilities in the area are sinking under skyrocketing debt, a flood of gruesome injuries and bloated business costs from the inflated economy.
The problems have been acute at McKenzie County Hospital here. Largely because of unpaid bills, the hospital’s debt has climbed more than 2,000 percent over the past four years to $1.2 million, according to Daniel Kelly, the hospital’s chief executive. Just three years ago, Mr. Kelly added, the hospital averaged 100 emergency room visits per month; last year, that average shot up to 400.
Over all, ambulance calls in the region increased by about 59 percent from 2006 to 2011, according to Thomas R. Nehring, the director of emergency medical services for the North Dakota Health Department. The number of traumatic injuries reported in the oil patch increased 200 percent from 2007 through the first half of last year, he said.
The 12 medical facilities in western North Dakota saw their combined debt rise by 46 percent over the course of the 2011 and 2012 fiscal years, according to Darrold Bertsch, the president of the state’s Rural Health Association.
Hospitals cannot simply refuse to treat people or raise their rates. Expenses at those 12 facilities increased by 15 percent, Mr. Bertsch added, and nine of them experienced operating losses. Costs are rising to hire and retain service staff members, as hospitals compete with fast food restaurants that pay wages of about $20 an hour.
“Plain and simple, those kinds of things are not sustainable,” he said.
Many of the new patients are transient men without health insurance or a permanent address in the area. In one of the biggest drivers of the hospital debt, patients give inaccurate contact information; when the time comes to collect payment, the patients cannot be found. McKenzie County Hospital has invested in new software that will help verify the information patients give on the spot.
Mr. Kelly has pushed for the state, which has a surplus of more than $1 billion, to allocate money intended for the oil region specifically to health care facilities in the area. He has also asked for the state to grant low-interest loans so hospitals can borrow money for facility improvements and for the governor to convene a task force to study health care issues in the oil patch.
Aides to Gov. Jack Dalrymple say he is taking steps to bolster medical training in the state, proposing to spend $68 million on a new medical school building at the University of North Dakota and $6 million to expand the nursing program at Lake Region State College. Mr. Dalrymple, a Republican, has also increased Medicaid financing for the state’s rural hospitals.
“Health care is certainly one of those areas that was targeted early on as we’ve seen growth out west,” said Jeffrey L. Zent, a spokesman for the governor.
Public utility numbers suggest that the population of Watford City has more than quadrupled to 6,500 over the past two years, Mr. Kelly said. In nearby Williston, considered the heart of the oil boom, the population, including temporary workers, has swelled to 25,000 to 33,000 from fewer than 15,000 in 2010, according to a study by North Dakota State University.
The huge population growth has produced new communities virtually overnight, creating logistical problems that affect the quality of medical care.
After a recent emergency call, Kelly Weathers, who has worked as a paramedic in the region for nearly 25 years, drove in circles with his team for about 15 minutes, searching for the address where they had been sent to treat a man who had hurt his back falling off a piece of equipment. But they could not find the street because a sign had not yet been erected. Eventually, a colleague of the injured man met the ambulance at the highway and escorted them to the site.
Mr. Weathers, who works for the Mountrail County Health Center in Stanley, said that in the past, “all the volunteers, they didn’t go by street signs.”
“It was like, ‘The corner store, third house to the north of that,’ ” he said. “So now, if you give them ‘62nd Avenue,’ they go, ‘Where’s that at?’ ”
Charles Quinn, 43, of Mississippi, has been working in the region for eight months repairing 18-wheelers. He said his job has its dangers because he often works under the trucks while they are running.
“It’s all kind of dangerous,” he said of the jobs in the oil patch. “There’s a lot more accidents around you because you got more people around you working.”
The cramped housing camps where many oil workers live can add to health issues. On a recent afternoon at McKenzie County Hospital, a man limped into the emergency room complaining about a dry, red patch of skin on his leg. Dr. Gary Ramage, the hospital’s sole full-time physician, said it was a bite from a brown recluse spider, which had most likely nested under the trailer where the man lives.
Since the oil industry started growing rapidly in the region, Dr. Ramage said, he has had to treat many more sexually transmitted diseases. Chlamydia rates in McKenzie County roughly doubled from 2010 to 2011.
With little money to spend, hospitals are struggling to finance sorely needed improvements and hire additional medical providers. McKenzie, which is six decades old, is a one-story brick building and has one room for emergencies. (A makeshift second emergency room was created from one of the inpatient rooms.) In a building across the street that houses a clinic, a narrow hallway with dark carpet is crowded with file drawers lining the walls.
Hospital executives are hoping to get the local government to approve a 1-cent sales tax increase so they can build a $55 million medical facility that would triple the size of the clinic, expand the emergency room, maintain the 24-bed hospital and increase space for other outpatient services like physical therapy. They have also spent the past year trying to hire two new doctors. Recruiting medical professionals to the area has long been a problem.
“Let’s be honest,” Mr. Kelly said. “People think they have to move to Siberia if they move to North Dakota.”
But for now, Dr. Ramage, a gregarious Canadian who has worked here for 18 years, is left shouldering much of the load. Before the oil boom started a few years back, Dr. Ramage covered both the clinic and the emergency room. Now he mostly works at the clinic, while the hospital hires roving physicians to cover the emergency room. He is well known in the community, and people call him at home when they are sick. But now, he does not know many of the patients he sees.
“My work is no longer small-town work,” he said. “My work has now been transformed from that of a small family practitioner to basically an E.R. doc.”
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Date: 2013-01-29 05:54 pm (UTC)no subject
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