John R. Bell

Where can you find a) a Mayo Clinic cigarette case, b) a “Dear Doctor” letter from a tobacco company, and c) scores of original smoking-related political cartoons?

The answer: At the National Museum of Health and Medicine, on the historic campus of soon-to-be-closed Walter Reed Army Hospital.

The exhibit consists of the best of more than 300 original cartoons acquired over a 35-year period by Dr. Alan Blum, professor of family medicine at the University of Alabama, Tuscaloosa.

He has campaigned against the tobacco industry since his days as a high school newspaper editor. “By the 1990s, I was plumb tuckered out. … I had lost my sense of humor.

“I started looking over all these cartoons that I had saved from the newspapers. And they made me laugh. And so I started writing one by one to each of the cartoonists, asking if I could acquire the originals.”

The display, which features the work of more than 50 nationally known cartoonists, is not without its share of controversy, Dr. Blum said. Several artifacts in the exhibit typify the medical profession's well-documented collusion with the tobacco industry. The American Medical Association for years held stock in R.J. Reynolds Corp. and Philip Morris USA, he noted.

“Not only did the tobacco companies sponsor exhibits and give away cartons of cigarettes at medical meetings until the 1980s, but for decades, beginning in the 1940s, the leadership of organized medicine was in cahoots with the tobacco industry,” he added.

Although “the story … is not full of a great many heroes,” he cited the former surgeon general Dr. C. Everett Koop as an exception, along with Nixon's surgeon general, Dr. Jesse L. Steinfeld, who issued the Nonsmokers' Bill of Rights against the advice of Elliot L. Richardson, former secretary of Health, Education, and Welfare.

The earliest reports of smoking's deleterious effects came from German researchers around the time of World War I. By 1928, the first epidemiologic report linking smoking and cancer was published in the New England Journal of Medicine by Dr. Herbert L. Lombard and Dr. Carl B. Doering. A decade later, Dr. Alton Ochsner and Dr. Michael DeBakey published a review of 400 articles on the subject, Dr. Blum said.

Yet despite the mounting evidence on smoking's health risks, physicians were complacent about acting on the science. “Doctors were laughing” at the notion that smoking could be harmful, Dr. Blum noted. “Two-thirds of physicians—like my father—smoked cigarettes.”

Dr. Blum's exhibit, which is scheduled to run through March 31, 2007, is intended to give the public the last laugh. For more information, call 202-782-2200 or go online to www.nmhm.washingtondc.museum

Where can you find a) a Mayo Clinic cigarette case, b) a “Dear Doctor” letter from a tobacco company, and c) scores of original smoking-related political cartoons?

The answer: At the National Museum of Health and Medicine, on the historic campus of soon-to-be-closed Walter Reed Army Hospital.

The exhibit consists of the best of more than 300 original cartoons acquired over a 35-year period by Dr. Alan Blum, professor of family medicine at the University of Alabama, Tuscaloosa.

He has campaigned against the tobacco industry since his days as a high school newspaper editor. “By the 1990s, I was plumb tuckered out. … I had lost my sense of humor.

“I started looking over all these cartoons that I had saved from the newspapers. And they made me laugh. And so I started writing one by one to each of the cartoonists, asking if I could acquire the originals.”

The display, which features the work of more than 50 nationally known cartoonists, is not without its share of controversy, Dr. Blum said. Several artifacts in the exhibit typify the medical profession's well-documented collusion with the tobacco industry. The American Medical Association for years held stock in R.J. Reynolds Corp. and Philip Morris USA, he noted.

“Not only did the tobacco companies sponsor exhibits and give away cartons of cigarettes at medical meetings until the 1980s, but for decades, beginning in the 1940s, the leadership of organized medicine was in cahoots with the tobacco industry,” he added.

Although “the story … is not full of a great many heroes,” he cited the former surgeon general Dr. C. Everett Koop as an exception, along with Nixon's surgeon general, Dr. Jesse L. Steinfeld, who issued the Nonsmokers' Bill of Rights against the advice of Elliot L. Richardson, former secretary of Health, Education, and Welfare.

The earliest reports of smoking's deleterious effects came from German researchers around the time of World War I. By 1928, the first epidemiologic report linking smoking and cancer was published in the New England Journal of Medicine by Dr. Herbert L. Lombard and Dr. Carl B. Doering. A decade later, Dr. Alton Ochsner and Dr. Michael DeBakey published a review of 400 articles on the subject, Dr. Blum said.

Yet despite the mounting evidence on smoking's health risks, physicians were complacent about acting on the science. “Doctors were laughing” at the notion that smoking could be harmful, Dr. Blum noted. “Two-thirds of physicians—like my father—smoked cigarettes.”

Dr. Blum's exhibit, which is scheduled to run through March 31, 2007, is intended to give the public the last laugh. For more information, call 202-782-2200 or go online to www.nmhm.washingtondc.museum

Where can you find a) a Mayo Clinic cigarette case, b) a “Dear Doctor” letter from a tobacco company, and c) scores of original smoking-related political cartoons?

The answer: At the National Museum of Health and Medicine, on the historic campus of soon-to-be-closed Walter Reed Army Hospital.

The exhibit consists of the best of more than 300 original cartoons acquired over a 35-year period by Dr. Alan Blum, professor of family medicine at the University of Alabama, Tuscaloosa.

He has campaigned against the tobacco industry since his days as a high school newspaper editor. “By the 1990s, I was plumb tuckered out. … I had lost my sense of humor.

“I started looking over all these cartoons that I had saved from the newspapers. And they made me laugh. And so I started writing one by one to each of the cartoonists, asking if I could acquire the originals.”

The display, which features the work of more than 50 nationally known cartoonists, is not without its share of controversy, Dr. Blum said. Several artifacts in the exhibit typify the medical profession's well-documented collusion with the tobacco industry. The American Medical Association for years held stock in R.J. Reynolds Corp. and Philip Morris USA, he noted.

“Not only did the tobacco companies sponsor exhibits and give away cartons of cigarettes at medical meetings until the 1980s, but for decades, beginning in the 1940s, the leadership of organized medicine was in cahoots with the tobacco industry,” he added.

Although “the story … is not full of a great many heroes,” he cited the former surgeon general Dr. C. Everett Koop as an exception, along with Nixon's surgeon general, Dr. Jesse L. Steinfeld, who issued the Nonsmokers' Bill of Rights against the advice of Elliot L. Richardson, former secretary of Health, Education, and Welfare.

The earliest reports of smoking's deleterious effects came from German researchers around the time of World War I. By 1928, the first epidemiologic report linking smoking and cancer was published in the New England Journal of Medicine by Dr. Herbert L. Lombard and Dr. Carl B. Doering. A decade later, Dr. Alton Ochsner and Dr. Michael DeBakey published a review of 400 articles on the subject, Dr. Blum said.

Yet despite the mounting evidence on smoking's health risks, physicians were complacent about acting on the science. “Doctors were laughing” at the notion that smoking could be harmful, Dr. Blum noted. “Two-thirds of physicians—like my father—smoked cigarettes.”

Dr. Blum's exhibit, which is scheduled to run through March 31, 2007, is intended to give the public the last laugh. For more information, call 202-782-2200 or go online to www.nmhm.washingtondc.museum

SAN ANTONIO — What is likely the first-ever case of dengue hemorrhagic fever to originate within Texas occurred last year among residents of the border area of South Texas, as did three endemic cases of classic dengue fever.

Physicians should consider dengue when diagnosing any resident of that region who presents with fever, an epidemiologist from the Texas Department of State Health Services reported.

Allison Abell, Ph.D., reported 18 dengue cases—three in the absence of recent international travel—in residents of greater Brownsville, Tex., found in 2005 by the Border Infectious Disease Surveillance project, a joint surveillance program of the United States and Mexico.

Her team had identified the patients via blood samples taken during home visits to 20 persons identified as at risk based on reports of undifferentiated fever, at least one IgM-positive test result, and patient questionnaires.

The team also conducted interviews and environmental assessments during those visits; notably, 3 of the 18 dengue cases were in people who denied having traveled to any foreign country in the last 3 months. Even more worrisome was that one of those three patients developed dengue hemorrhagic fever, rather than the less-severe classic dengue fever seen in the other 17.

That case apparently “represents the first classically presented case of [dengue hemorrhagic fever] with transmission within Texas,” Dr. Abell said at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man. A prior case of dengue hemorrhagic fever appeared with unusual symptoms several years ago, she noted. Untreated dengue hemorrhagic fever has a mortality of around 50%, but treatment reduces the rate to roughly 5%, she added.

Moreover, three asymptomatic household contacts of the 18 patients tested IgM-positive for dengue, and one denied any recent foreign travel, Dr. Abell reported. Of the 18 cases, 14 were in residents of the Brownsville area, directly across the border from Matamoros, Mexico.

Although dengue fever is not rare in persons returning to the United States from dengue-endemic regions abroad, endemic cases with the United States have been rare since the end of World War II, according to the Centers for Disease Control and Prevention. Only a few indigenous dengue cases have occurred here in the last few years, most of them in Texas. (Hawaii reported 15 cases in 2001–2002.) However, dengue infection is not nationally notifiable, and reporting is passive; thus, incidence might be underreported, the CDC noted.

Dr. Abell and her colleagues identified environmental risk factors for 15 of the 18 dengue patients by visiting their homes. Dengue is transmitted by the Aedes aegypti mosquito and occurs in four serotypes. Objects that collect rainwater, such as pet dishes and toys, were present outside the homes of 9 of the 15 patients (60%). Unmounted tires were present on the property of six patients (40%). And five patients (33%) had windows without screens at their homes. About half the patients reported rarely or never using insect repellent, and two-thirds reported never wearing protective clothing during outdoor activities, Dr. Abell said.

Clinical symptoms reported were sudden onset of fever and headache, often with retroorbital pain, as well as muscle and joint pain, rash, and bleeding in some cases. Almost all patients were Hispanic, and slightly more than half were female. “The most common risk factor really was travel,” with 15 of the 18 reporting recent travel to Mexico, Dr. Abell noted at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

Overall, Texas has reported fewer than 10 cases per year of dengue in the last decade, Dr. Abell reported, with the exception of 1999, when an outbreak of 66 cases, including 2 probably indigenous cases, hit the border town of Laredo.

SAN ANTONIO — What is likely the first-ever case of dengue hemorrhagic fever to originate within Texas occurred last year among residents of the border area of South Texas, as did three endemic cases of classic dengue fever.

Physicians should consider dengue when diagnosing any resident of that region who presents with fever, an epidemiologist from the Texas Department of State Health Services reported.

Allison Abell, Ph.D., reported 18 dengue cases—three in the absence of recent international travel—in residents of greater Brownsville, Tex., found in 2005 by the Border Infectious Disease Surveillance project, a joint surveillance program of the United States and Mexico.

Her team had identified the patients via blood samples taken during home visits to 20 persons identified as at risk based on reports of undifferentiated fever, at least one IgM-positive test result, and patient questionnaires.

The team also conducted interviews and environmental assessments during those visits; notably, 3 of the 18 dengue cases were in people who denied having traveled to any foreign country in the last 3 months. Even more worrisome was that one of those three patients developed dengue hemorrhagic fever, rather than the less-severe classic dengue fever seen in the other 17.

That case apparently “represents the first classically presented case of [dengue hemorrhagic fever] with transmission within Texas,” Dr. Abell said at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man. A prior case of dengue hemorrhagic fever appeared with unusual symptoms several years ago, she noted. Untreated dengue hemorrhagic fever has a mortality of around 50%, but treatment reduces the rate to roughly 5%, she added.

Moreover, three asymptomatic household contacts of the 18 patients tested IgM-positive for dengue, and one denied any recent foreign travel, Dr. Abell reported. Of the 18 cases, 14 were in residents of the Brownsville area, directly across the border from Matamoros, Mexico.

Although dengue fever is not rare in persons returning to the United States from dengue-endemic regions abroad, endemic cases with the United States have been rare since the end of World War II, according to the Centers for Disease Control and Prevention. Only a few indigenous dengue cases have occurred here in the last few years, most of them in Texas. (Hawaii reported 15 cases in 2001–2002.) However, dengue infection is not nationally notifiable, and reporting is passive; thus, incidence might be underreported, the CDC noted.

Dr. Abell and her colleagues identified environmental risk factors for 15 of the 18 dengue patients by visiting their homes. Dengue is transmitted by the Aedes aegypti mosquito and occurs in four serotypes. Objects that collect rainwater, such as pet dishes and toys, were present outside the homes of 9 of the 15 patients (60%). Unmounted tires were present on the property of six patients (40%). And five patients (33%) had windows without screens at their homes. About half the patients reported rarely or never using insect repellent, and two-thirds reported never wearing protective clothing during outdoor activities, Dr. Abell said.

Clinical symptoms reported were sudden onset of fever and headache, often with retroorbital pain, as well as muscle and joint pain, rash, and bleeding in some cases. Almost all patients were Hispanic, and slightly more than half were female. “The most common risk factor really was travel,” with 15 of the 18 reporting recent travel to Mexico, Dr. Abell noted at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

Overall, Texas has reported fewer than 10 cases per year of dengue in the last decade, Dr. Abell reported, with the exception of 1999, when an outbreak of 66 cases, including 2 probably indigenous cases, hit the border town of Laredo.

SAN ANTONIO — What is likely the first-ever case of dengue hemorrhagic fever to originate within Texas occurred last year among residents of the border area of South Texas, as did three endemic cases of classic dengue fever.

Physicians should consider dengue when diagnosing any resident of that region who presents with fever, an epidemiologist from the Texas Department of State Health Services reported.

Allison Abell, Ph.D., reported 18 dengue cases—three in the absence of recent international travel—in residents of greater Brownsville, Tex., found in 2005 by the Border Infectious Disease Surveillance project, a joint surveillance program of the United States and Mexico.

Her team had identified the patients via blood samples taken during home visits to 20 persons identified as at risk based on reports of undifferentiated fever, at least one IgM-positive test result, and patient questionnaires.

The team also conducted interviews and environmental assessments during those visits; notably, 3 of the 18 dengue cases were in people who denied having traveled to any foreign country in the last 3 months. Even more worrisome was that one of those three patients developed dengue hemorrhagic fever, rather than the less-severe classic dengue fever seen in the other 17.

That case apparently “represents the first classically presented case of [dengue hemorrhagic fever] with transmission within Texas,” Dr. Abell said at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man. A prior case of dengue hemorrhagic fever appeared with unusual symptoms several years ago, she noted. Untreated dengue hemorrhagic fever has a mortality of around 50%, but treatment reduces the rate to roughly 5%, she added.

Moreover, three asymptomatic household contacts of the 18 patients tested IgM-positive for dengue, and one denied any recent foreign travel, Dr. Abell reported. Of the 18 cases, 14 were in residents of the Brownsville area, directly across the border from Matamoros, Mexico.

Although dengue fever is not rare in persons returning to the United States from dengue-endemic regions abroad, endemic cases with the United States have been rare since the end of World War II, according to the Centers for Disease Control and Prevention. Only a few indigenous dengue cases have occurred here in the last few years, most of them in Texas. (Hawaii reported 15 cases in 2001–2002.) However, dengue infection is not nationally notifiable, and reporting is passive; thus, incidence might be underreported, the CDC noted.

Dr. Abell and her colleagues identified environmental risk factors for 15 of the 18 dengue patients by visiting their homes. Dengue is transmitted by the Aedes aegypti mosquito and occurs in four serotypes. Objects that collect rainwater, such as pet dishes and toys, were present outside the homes of 9 of the 15 patients (60%). Unmounted tires were present on the property of six patients (40%). And five patients (33%) had windows without screens at their homes. About half the patients reported rarely or never using insect repellent, and two-thirds reported never wearing protective clothing during outdoor activities, Dr. Abell said.

Clinical symptoms reported were sudden onset of fever and headache, often with retroorbital pain, as well as muscle and joint pain, rash, and bleeding in some cases. Almost all patients were Hispanic, and slightly more than half were female. “The most common risk factor really was travel,” with 15 of the 18 reporting recent travel to Mexico, Dr. Abell noted at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

Overall, Texas has reported fewer than 10 cases per year of dengue in the last decade, Dr. Abell reported, with the exception of 1999, when an outbreak of 66 cases, including 2 probably indigenous cases, hit the border town of Laredo.

SAN ANTONIO — Salmonella infections that simultaneously occurred in four children at a Michigan elementary school were traced to mice that had been shipped to the school from a business in Texas as food for a classroom pet snake, according to a researcher with the Texas Department of State Health Services.

The incident was detailed in a poster presented by Carol M. Davis, Ph.D., at the Southwest Conference on Diseases in Nature Transmissible to Man.

The initial cases were reported to the Centers for Disease Control and Prevention, Atlanta, and the results of pulsed-field gel electrophoresis tests were entered into a CDC database called PulseNet.

Using PulseNet, the state of Minnesota discovered that recent human cases in that state were enzymatically similar to those from the Michigan children. An investigation determined that three Salmonella-positive mice shipped by the business were the likely vector.

Dr. Davis and colleagues then conducted an inspection of the breeding facility, a small operation that showed signs of lax sanitation.

Samples of rodent feed, rodent feces, and the rodents themselves were positive for salmonella. The business was subsequently brought into compliance by Texas authorities.

A total of 12 human salmonella cases were linked to the mouse-breeding business.

Dr. Davis and her coinvestigators said that individuals should be more vigilant about washing their hands after they handle rodents and pet reptiles, and the investigators also recommended better warning labels on the packaging of food rodents.

SAN ANTONIO — Salmonella infections that simultaneously occurred in four children at a Michigan elementary school were traced to mice that had been shipped to the school from a business in Texas as food for a classroom pet snake, according to a researcher with the Texas Department of State Health Services.

The incident was detailed in a poster presented by Carol M. Davis, Ph.D., at the Southwest Conference on Diseases in Nature Transmissible to Man.

The initial cases were reported to the Centers for Disease Control and Prevention, Atlanta, and the results of pulsed-field gel electrophoresis tests were entered into a CDC database called PulseNet.

Using PulseNet, the state of Minnesota discovered that recent human cases in that state were enzymatically similar to those from the Michigan children. An investigation determined that three Salmonella-positive mice shipped by the business were the likely vector.

Dr. Davis and colleagues then conducted an inspection of the breeding facility, a small operation that showed signs of lax sanitation.

Samples of rodent feed, rodent feces, and the rodents themselves were positive for salmonella. The business was subsequently brought into compliance by Texas authorities.

A total of 12 human salmonella cases were linked to the mouse-breeding business.

Dr. Davis and her coinvestigators said that individuals should be more vigilant about washing their hands after they handle rodents and pet reptiles, and the investigators also recommended better warning labels on the packaging of food rodents.

SAN ANTONIO — Salmonella infections that simultaneously occurred in four children at a Michigan elementary school were traced to mice that had been shipped to the school from a business in Texas as food for a classroom pet snake, according to a researcher with the Texas Department of State Health Services.

The incident was detailed in a poster presented by Carol M. Davis, Ph.D., at the Southwest Conference on Diseases in Nature Transmissible to Man.

The initial cases were reported to the Centers for Disease Control and Prevention, Atlanta, and the results of pulsed-field gel electrophoresis tests were entered into a CDC database called PulseNet.

Using PulseNet, the state of Minnesota discovered that recent human cases in that state were enzymatically similar to those from the Michigan children. An investigation determined that three Salmonella-positive mice shipped by the business were the likely vector.

Dr. Davis and colleagues then conducted an inspection of the breeding facility, a small operation that showed signs of lax sanitation.

Samples of rodent feed, rodent feces, and the rodents themselves were positive for salmonella. The business was subsequently brought into compliance by Texas authorities.

A total of 12 human salmonella cases were linked to the mouse-breeding business.

Dr. Davis and her coinvestigators said that individuals should be more vigilant about washing their hands after they handle rodents and pet reptiles, and the investigators also recommended better warning labels on the packaging of food rodents.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats.

The vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to E. ruminantium, which is considered common in Africa and the Caribbean but so far unreported in the United States.

The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick.

The physician suspected tickborne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Furthermore, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks.

No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said.

“The scary thing is that the Hartsfield International Airport, a U.S.D.A. port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of E. ruminantium, but only 3 of these species live in the United States, she noted.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats.

The vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to E. ruminantium, which is considered common in Africa and the Caribbean but so far unreported in the United States.

The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick.

The physician suspected tickborne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Furthermore, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks.

No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said.

“The scary thing is that the Hartsfield International Airport, a U.S.D.A. port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of E. ruminantium, but only 3 of these species live in the United States, she noted.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats.

The vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to E. ruminantium, which is considered common in Africa and the Caribbean but so far unreported in the United States.

The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick.

The physician suspected tickborne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Furthermore, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks.

No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said.

“The scary thing is that the Hartsfield International Airport, a U.S.D.A. port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of E. ruminantium, but only 3 of these species live in the United States, she noted.

In a prospective analysis of data from children who had laboratory-confirmed influenza, researchers found that most influenza cases were not recognized clinically, and the resulting symptoms were treated on an outpatient basis far more often than through inpatient care.

Dr. Katherine A. Poehling of Vanderbilt University, Nashville, Tenn., and her colleagues reported data from the New Vaccine Surveillance Network, organized by the Centers for Disease Control and Prevention, in which they observed hospitalizations and pediatric clinic visits resulting from acute respiratory illness or fever in children younger than 5 years who were living in one of three U.S. counties during 2000–2004 (N. Engl. J. Med. 2006;355:31–40).

They found that among the outpatient population of 1,668 children, 16% (267 children) tested positive for influenza, compared with less than 6% (160 children) of the 2,797 in the inpatient group. However, discharge diagnoses identified influenza in only 17% of outpatients and 28% of hospitalized patients with laboratory-confirmed influenza.

Outpatient care was overwhelmingly predominant in the study cohort. During the 4-year study period, the average hospitalization rate for all included age groups was 1 per 1,000 children, and outpatient treatment rates for each group (younger than 6 months, 6 months to 1 year old, and 1–2 years old) were 10, 100, and 250 times higher than the rates of hospitalizations, respectively.

Moreover, the investigators found that laboratory-confirmed flu infections accounted for more than 10% of weekly clinic visits for acute respiratory tract infection or fever during the 2002–2003 flu season and more than 19% of such visits during the 2003–2004 season. In the emergency department, laboratory-confirmed flu infections accounted for nearly 6% of weekly visits for acute respiratory tract infection or fever in 2002–2003 and 29% of such visits in 2003–2004.

“Much of this influenza disease burden may be prevented through vaccination,” the researchers wrote. Influenza vaccination for all children aged 6–23 months was recommended beginning in 2004.

Notably, younger patients had greater influenza incidence. In the hospitalized patients, 80% were younger than 2 years and 49% were younger than 6 months. In the outpatient group, 47% were younger than 2 years, and 7% were younger than 6 months.

In an accompanying editorial, Dr. W. Paul Glezen of Baylor College of Medicine, Houston, observed that uninsured families, who compose almost one-fifth of the U.S. population, were underrepresented in the study, which might have contributed to artificially low hospitalization rates in the study (N. Engl. J. Med. 2006;355:79–81).

In a prospective analysis of data from children who had laboratory-confirmed influenza, researchers found that most influenza cases were not recognized clinically, and the resulting symptoms were treated on an outpatient basis far more often than through inpatient care.

Dr. Katherine A. Poehling of Vanderbilt University, Nashville, Tenn., and her colleagues reported data from the New Vaccine Surveillance Network, organized by the Centers for Disease Control and Prevention, in which they observed hospitalizations and pediatric clinic visits resulting from acute respiratory illness or fever in children younger than 5 years who were living in one of three U.S. counties during 2000–2004 (N. Engl. J. Med. 2006;355:31–40).

They found that among the outpatient population of 1,668 children, 16% (267 children) tested positive for influenza, compared with less than 6% (160 children) of the 2,797 in the inpatient group. However, discharge diagnoses identified influenza in only 17% of outpatients and 28% of hospitalized patients with laboratory-confirmed influenza.

Outpatient care was overwhelmingly predominant in the study cohort. During the 4-year study period, the average hospitalization rate for all included age groups was 1 per 1,000 children, and outpatient treatment rates for each group (younger than 6 months, 6 months to 1 year old, and 1–2 years old) were 10, 100, and 250 times higher than the rates of hospitalizations, respectively.

Moreover, the investigators found that laboratory-confirmed flu infections accounted for more than 10% of weekly clinic visits for acute respiratory tract infection or fever during the 2002–2003 flu season and more than 19% of such visits during the 2003–2004 season. In the emergency department, laboratory-confirmed flu infections accounted for nearly 6% of weekly visits for acute respiratory tract infection or fever in 2002–2003 and 29% of such visits in 2003–2004.

“Much of this influenza disease burden may be prevented through vaccination,” the researchers wrote. Influenza vaccination for all children aged 6–23 months was recommended beginning in 2004.

Notably, younger patients had greater influenza incidence. In the hospitalized patients, 80% were younger than 2 years and 49% were younger than 6 months. In the outpatient group, 47% were younger than 2 years, and 7% were younger than 6 months.

In an accompanying editorial, Dr. W. Paul Glezen of Baylor College of Medicine, Houston, observed that uninsured families, who compose almost one-fifth of the U.S. population, were underrepresented in the study, which might have contributed to artificially low hospitalization rates in the study (N. Engl. J. Med. 2006;355:79–81).

In a prospective analysis of data from children who had laboratory-confirmed influenza, researchers found that most influenza cases were not recognized clinically, and the resulting symptoms were treated on an outpatient basis far more often than through inpatient care.

Dr. Katherine A. Poehling of Vanderbilt University, Nashville, Tenn., and her colleagues reported data from the New Vaccine Surveillance Network, organized by the Centers for Disease Control and Prevention, in which they observed hospitalizations and pediatric clinic visits resulting from acute respiratory illness or fever in children younger than 5 years who were living in one of three U.S. counties during 2000–2004 (N. Engl. J. Med. 2006;355:31–40).

They found that among the outpatient population of 1,668 children, 16% (267 children) tested positive for influenza, compared with less than 6% (160 children) of the 2,797 in the inpatient group. However, discharge diagnoses identified influenza in only 17% of outpatients and 28% of hospitalized patients with laboratory-confirmed influenza.

Outpatient care was overwhelmingly predominant in the study cohort. During the 4-year study period, the average hospitalization rate for all included age groups was 1 per 1,000 children, and outpatient treatment rates for each group (younger than 6 months, 6 months to 1 year old, and 1–2 years old) were 10, 100, and 250 times higher than the rates of hospitalizations, respectively.

Moreover, the investigators found that laboratory-confirmed flu infections accounted for more than 10% of weekly clinic visits for acute respiratory tract infection or fever during the 2002–2003 flu season and more than 19% of such visits during the 2003–2004 season. In the emergency department, laboratory-confirmed flu infections accounted for nearly 6% of weekly visits for acute respiratory tract infection or fever in 2002–2003 and 29% of such visits in 2003–2004.

“Much of this influenza disease burden may be prevented through vaccination,” the researchers wrote. Influenza vaccination for all children aged 6–23 months was recommended beginning in 2004.

Notably, younger patients had greater influenza incidence. In the hospitalized patients, 80% were younger than 2 years and 49% were younger than 6 months. In the outpatient group, 47% were younger than 2 years, and 7% were younger than 6 months.

In an accompanying editorial, Dr. W. Paul Glezen of Baylor College of Medicine, Houston, observed that uninsured families, who compose almost one-fifth of the U.S. population, were underrepresented in the study, which might have contributed to artificially low hospitalization rates in the study (N. Engl. J. Med. 2006;355:79–81).

BALTIMORE — There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs—but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

“Other courts would be less likely to find that such proposals are reasonable accommodations. The courts are concerned that those proposals unfairly penalize employees who raise conscience-based claims. Courts clearly vary in the way that they approach this question.”

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

BALTIMORE — There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs—but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

“Other courts would be less likely to find that such proposals are reasonable accommodations. The courts are concerned that those proposals unfairly penalize employees who raise conscience-based claims. Courts clearly vary in the way that they approach this question.”

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

BALTIMORE — There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs—but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

“Other courts would be less likely to find that such proposals are reasonable accommodations. The courts are concerned that those proposals unfairly penalize employees who raise conscience-based claims. Courts clearly vary in the way that they approach this question.”

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

WASHINGTON — Abuse of illegal drugs by young adults increased between 2004 and 2005, and drug abuse by adults in their 50s has climbed by nearly two-thirds over the last 4 years, according to survey data reported by the Substance Abuse and Mental Health Services Administration.

Moreover, the use of any illegal drug in the past year among those 65 years old or older nearly doubled during 2004–2005, from 0.9% to 1.7%, and the portion in the 60–64 age group reporting past-year drug abuse rose more than 50%, from 2.0 in 2004 to 3.2% in 2005, according to data from the 2005 National Survey on Drug Use and Health (NSDUH), formerly called the National Household Survey on Drug Abuse.

Despite these figures, abuse of most illegal drugs by minors dropped between 2004 and 2005, according to NSDUH data presented at a press briefing.

SAMHSA officials characterized the overall data as evidence that their programs have been successful. “The news today is there is a fundamental shift in drug use among young people in America,” acting deputy SAMHSA administrator Eric Broderick, D.D.S., said in a statement.

Still, persons in the 18- to 25-year-old age group had the greatest reported prevalence of drug use in 2005, the report noted.

From 2004 to 2005, the number of past-month users increased among young adults for almost all drugs. For these young adults, reported use of marijuana in the past month rose from 16.1% to 16.6%, according to the report. Similar small increases were noted in use of psychotherapeutics (from 6.1% to 6.3%), cocaine (2.1% to 2.6%), and inhalants (0.4% to 0.5%), whereas past-month use of hallucinogens remained at 1.5%. For all illicit drugs other than marijuana, the percentage of users in the past month in the 18–25 group rose between 2004 and 2005, from 8.1% to 8.8% of respondents.

Notably, self-reported use of any illicit drug among those aged 50–59 has risen each of the last 4 years, from under 3% in 2002 to more than 4% in 2005—an increase of 63%.

The NSDUH data do show some decreases in drug use. For persons aged 12–17 years, self-reported use of marijuana in the preceding month has dropped in each of the last 4 years; past-month marijuana use between 2004 and 2005 decreased from 7.6% to 6.8% of this middle-school and high-school age group.

Also, past-month illegal use of prescription psychotherapeutics among 12- to 17-year-olds decreased from 3.6% in 2004 to 3.3% in 2005, and past-month illegal use of inhalants and hallucinogens each remained the same, at 1.2% and 0.8%, respectively.

For cocaine use, however, there was a slight increase in past-month use in the 12–17 age group, from 0.5% to 0.6%.

For all persons queried in the NSDUH (aged 12 and older), the percentage indicating past-month use of marijuana dropped from 6.1% in 2004 to 6.0% last year; the number of persons of all ages who reported first-time use of methamphetamine in the previous year declined 40% between 2004 and 2005, from 318,000 to 192,000. That number had risen 22% between 2003 (260,000) and 2004.

Methamphetamine in particular saw a precipitous drop. For all ages, “lifetime methamphetamine use declined 19% since 2002 and dropped 12% in a single year, the 2004–2005 period,” John Walters, director of the White House Office of National Drug Control Policy, noted at the briefing. The mean age at which marijuana was first used rose slightly from 17.1 years in 2004 to 17.4 years in 2005, compared with 17.0 years in 2002 and 16.8 years in 2003, he said.

Overall past-month tobacco use for all age groups increased slightly from 2004, from 29.2% to 29.4%, but among those aged 12–17 years, overall use declined, from 14.4% to 13.1%. Underage alcohol use posted a slight decline from 2004, from 28.7% to 28.2%.

The most recent NSDUH was administered to nearly 68,000 persons in the United States. The survey is given in respondents' homes and excludes inmates, hospital patients, nursing home residents, military personnel, homeless not living in shelters, and persons younger than 12 years.

For the past 2 years, the survey has paid respondents $30 for participating; any influence this practice might have had on responses is not discussed in the report. The sampling for the survey also changed in 2005, from being based on census area segments to being based on census tracts.

WASHINGTON — Abuse of illegal drugs by young adults increased between 2004 and 2005, and drug abuse by adults in their 50s has climbed by nearly two-thirds over the last 4 years, according to survey data reported by the Substance Abuse and Mental Health Services Administration.

Moreover, the use of any illegal drug in the past year among those 65 years old or older nearly doubled during 2004–2005, from 0.9% to 1.7%, and the portion in the 60–64 age group reporting past-year drug abuse rose more than 50%, from 2.0 in 2004 to 3.2% in 2005, according to data from the 2005 National Survey on Drug Use and Health (NSDUH), formerly called the National Household Survey on Drug Abuse.

Despite these figures, abuse of most illegal drugs by minors dropped between 2004 and 2005, according to NSDUH data presented at a press briefing.

SAMHSA officials characterized the overall data as evidence that their programs have been successful. “The news today is there is a fundamental shift in drug use among young people in America,” acting deputy SAMHSA administrator Eric Broderick, D.D.S., said in a statement.

Still, persons in the 18- to 25-year-old age group had the greatest reported prevalence of drug use in 2005, the report noted.

From 2004 to 2005, the number of past-month users increased among young adults for almost all drugs. For these young adults, reported use of marijuana in the past month rose from 16.1% to 16.6%, according to the report. Similar small increases were noted in use of psychotherapeutics (from 6.1% to 6.3%), cocaine (2.1% to 2.6%), and inhalants (0.4% to 0.5%), whereas past-month use of hallucinogens remained at 1.5%. For all illicit drugs other than marijuana, the percentage of users in the past month in the 18–25 group rose between 2004 and 2005, from 8.1% to 8.8% of respondents.

Notably, self-reported use of any illicit drug among those aged 50–59 has risen each of the last 4 years, from under 3% in 2002 to more than 4% in 2005—an increase of 63%.

The NSDUH data do show some decreases in drug use. For persons aged 12–17 years, self-reported use of marijuana in the preceding month has dropped in each of the last 4 years; past-month marijuana use between 2004 and 2005 decreased from 7.6% to 6.8% of this middle-school and high-school age group.

Also, past-month illegal use of prescription psychotherapeutics among 12- to 17-year-olds decreased from 3.6% in 2004 to 3.3% in 2005, and past-month illegal use of inhalants and hallucinogens each remained the same, at 1.2% and 0.8%, respectively.

For cocaine use, however, there was a slight increase in past-month use in the 12–17 age group, from 0.5% to 0.6%.

For all persons queried in the NSDUH (aged 12 and older), the percentage indicating past-month use of marijuana dropped from 6.1% in 2004 to 6.0% last year; the number of persons of all ages who reported first-time use of methamphetamine in the previous year declined 40% between 2004 and 2005, from 318,000 to 192,000. That number had risen 22% between 2003 (260,000) and 2004.

Methamphetamine in particular saw a precipitous drop. For all ages, “lifetime methamphetamine use declined 19% since 2002 and dropped 12% in a single year, the 2004–2005 period,” John Walters, director of the White House Office of National Drug Control Policy, noted at the briefing. The mean age at which marijuana was first used rose slightly from 17.1 years in 2004 to 17.4 years in 2005, compared with 17.0 years in 2002 and 16.8 years in 2003, he said.

Overall past-month tobacco use for all age groups increased slightly from 2004, from 29.2% to 29.4%, but among those aged 12–17 years, overall use declined, from 14.4% to 13.1%. Underage alcohol use posted a slight decline from 2004, from 28.7% to 28.2%.

The most recent NSDUH was administered to nearly 68,000 persons in the United States. The survey is given in respondents' homes and excludes inmates, hospital patients, nursing home residents, military personnel, homeless not living in shelters, and persons younger than 12 years.

For the past 2 years, the survey has paid respondents $30 for participating; any influence this practice might have had on responses is not discussed in the report. The sampling for the survey also changed in 2005, from being based on census area segments to being based on census tracts.

WASHINGTON — Abuse of illegal drugs by young adults increased between 2004 and 2005, and drug abuse by adults in their 50s has climbed by nearly two-thirds over the last 4 years, according to survey data reported by the Substance Abuse and Mental Health Services Administration.

Moreover, the use of any illegal drug in the past year among those 65 years old or older nearly doubled during 2004–2005, from 0.9% to 1.7%, and the portion in the 60–64 age group reporting past-year drug abuse rose more than 50%, from 2.0 in 2004 to 3.2% in 2005, according to data from the 2005 National Survey on Drug Use and Health (NSDUH), formerly called the National Household Survey on Drug Abuse.

Despite these figures, abuse of most illegal drugs by minors dropped between 2004 and 2005, according to NSDUH data presented at a press briefing.

SAMHSA officials characterized the overall data as evidence that their programs have been successful. “The news today is there is a fundamental shift in drug use among young people in America,” acting deputy SAMHSA administrator Eric Broderick, D.D.S., said in a statement.

Still, persons in the 18- to 25-year-old age group had the greatest reported prevalence of drug use in 2005, the report noted.

From 2004 to 2005, the number of past-month users increased among young adults for almost all drugs. For these young adults, reported use of marijuana in the past month rose from 16.1% to 16.6%, according to the report. Similar small increases were noted in use of psychotherapeutics (from 6.1% to 6.3%), cocaine (2.1% to 2.6%), and inhalants (0.4% to 0.5%), whereas past-month use of hallucinogens remained at 1.5%. For all illicit drugs other than marijuana, the percentage of users in the past month in the 18–25 group rose between 2004 and 2005, from 8.1% to 8.8% of respondents.

Notably, self-reported use of any illicit drug among those aged 50–59 has risen each of the last 4 years, from under 3% in 2002 to more than 4% in 2005—an increase of 63%.

The NSDUH data do show some decreases in drug use. For persons aged 12–17 years, self-reported use of marijuana in the preceding month has dropped in each of the last 4 years; past-month marijuana use between 2004 and 2005 decreased from 7.6% to 6.8% of this middle-school and high-school age group.

Also, past-month illegal use of prescription psychotherapeutics among 12- to 17-year-olds decreased from 3.6% in 2004 to 3.3% in 2005, and past-month illegal use of inhalants and hallucinogens each remained the same, at 1.2% and 0.8%, respectively.

For cocaine use, however, there was a slight increase in past-month use in the 12–17 age group, from 0.5% to 0.6%.

For all persons queried in the NSDUH (aged 12 and older), the percentage indicating past-month use of marijuana dropped from 6.1% in 2004 to 6.0% last year; the number of persons of all ages who reported first-time use of methamphetamine in the previous year declined 40% between 2004 and 2005, from 318,000 to 192,000. That number had risen 22% between 2003 (260,000) and 2004.

Methamphetamine in particular saw a precipitous drop. For all ages, “lifetime methamphetamine use declined 19% since 2002 and dropped 12% in a single year, the 2004–2005 period,” John Walters, director of the White House Office of National Drug Control Policy, noted at the briefing. The mean age at which marijuana was first used rose slightly from 17.1 years in 2004 to 17.4 years in 2005, compared with 17.0 years in 2002 and 16.8 years in 2003, he said.

Overall past-month tobacco use for all age groups increased slightly from 2004, from 29.2% to 29.4%, but among those aged 12–17 years, overall use declined, from 14.4% to 13.1%. Underage alcohol use posted a slight decline from 2004, from 28.7% to 28.2%.

The most recent NSDUH was administered to nearly 68,000 persons in the United States. The survey is given in respondents' homes and excludes inmates, hospital patients, nursing home residents, military personnel, homeless not living in shelters, and persons younger than 12 years.

For the past 2 years, the survey has paid respondents $30 for participating; any influence this practice might have had on responses is not discussed in the report. The sampling for the survey also changed in 2005, from being based on census area segments to being based on census tracts.

BALTIMORE – There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs–but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith–as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations–like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally–regardless of their status as employee or independent contractors–to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action–and variation–on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

BALTIMORE – There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs–but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith–as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations–like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally–regardless of their status as employee or independent contractors–to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action–and variation–on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

BALTIMORE – There are many situations in which a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs–but the best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Although Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus institutions are likely to see such notice as a gesture of good faith–as are courts, if a matter ever ends up in litigation.”

Treatments that more often result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, and sterilization procedures.

What a physician is legally obligated to do varies by state. Although in most states, while physicians are required to perform any emergency treatment, emergency contraceptives are often placed in a different category.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” Ms. Norton said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations–like public health emergencies or in the middle of patient care when no other provider is available. But as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors.

“Most state conscience clause statutes, on the other hand, allow health care workers generally–regardless of their status as employee or independent contractors–to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” Ms. Norton said. “What does 'reasonable accommodation' mean? Some courts define reasonable accommodation to mean any change offered by the employer that would eliminate the conflict between the employee's conscience and his or her job. This would include a transfer to a job that does not involve the challenged procedure, even if the new job offers less pay or a less attractive location.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action–and variation–on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, Dr. G¨nther Deuschl and colleagues reported.

Results of a new randomized controlled trial from the German Parkinson Study Group of a nonblinded, intention-to-treat population of 78 patient pairs (156 patients) were reported by Dr. Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues. Patients were recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

Primary outcomes were changes in quality of life, as reflected in scores on the Parkinson's Disease Questionnaire (PDQ-39) summary index, and changes in symptom severity after medication withdrawal, as measured by the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), the investigators reported.

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in PDQ-39 summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 41.8 at baseline in the neurostimulation group to 31.8 at 6 months–an improvement of 24%. In the medication-only group, the mean score was 39.6 at baseline and 40.2 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the UPDRS-III after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, reported Dr. Deuschl and colleagues. The neurostimulation group's mean score was 48.0 without medication at baseline, improving to 28.3 at 6 months. For the nonstimulation group, the mean score barely changed, going from 46.8 at baseline to 46.0 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey.

Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group; the exceptions were nonsignificant, except for medication dosage, which declined for both groups, but far more so in the neurostimulation group (49% vs. 10%, respectively). Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups.

The investigators reported 13 adverse events–10 in the neurostimulation group and 3 in the medication-only group. Three patients in the neurostimulation group died, one as a result of a hematoma occurring during surgery, one from pneumonia, and one from suicide. A patient in the medication group died after driving during a psychotic episode.

The overall results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” Dr. Deuschl and colleagues cautioned.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, Dr. G¨nther Deuschl and colleagues reported.

Results of a new randomized controlled trial from the German Parkinson Study Group of a nonblinded, intention-to-treat population of 78 patient pairs (156 patients) were reported by Dr. Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues. Patients were recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

Primary outcomes were changes in quality of life, as reflected in scores on the Parkinson's Disease Questionnaire (PDQ-39) summary index, and changes in symptom severity after medication withdrawal, as measured by the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), the investigators reported.

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in PDQ-39 summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 41.8 at baseline in the neurostimulation group to 31.8 at 6 months–an improvement of 24%. In the medication-only group, the mean score was 39.6 at baseline and 40.2 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the UPDRS-III after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, reported Dr. Deuschl and colleagues. The neurostimulation group's mean score was 48.0 without medication at baseline, improving to 28.3 at 6 months. For the nonstimulation group, the mean score barely changed, going from 46.8 at baseline to 46.0 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey.

Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group; the exceptions were nonsignificant, except for medication dosage, which declined for both groups, but far more so in the neurostimulation group (49% vs. 10%, respectively). Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups.

The investigators reported 13 adverse events–10 in the neurostimulation group and 3 in the medication-only group. Three patients in the neurostimulation group died, one as a result of a hematoma occurring during surgery, one from pneumonia, and one from suicide. A patient in the medication group died after driving during a psychotic episode.

The overall results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” Dr. Deuschl and colleagues cautioned.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, Dr. G¨nther Deuschl and colleagues reported.

Results of a new randomized controlled trial from the German Parkinson Study Group of a nonblinded, intention-to-treat population of 78 patient pairs (156 patients) were reported by Dr. Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues. Patients were recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

Primary outcomes were changes in quality of life, as reflected in scores on the Parkinson's Disease Questionnaire (PDQ-39) summary index, and changes in symptom severity after medication withdrawal, as measured by the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), the investigators reported.

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in PDQ-39 summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 41.8 at baseline in the neurostimulation group to 31.8 at 6 months–an improvement of 24%. In the medication-only group, the mean score was 39.6 at baseline and 40.2 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the UPDRS-III after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, reported Dr. Deuschl and colleagues. The neurostimulation group's mean score was 48.0 without medication at baseline, improving to 28.3 at 6 months. For the nonstimulation group, the mean score barely changed, going from 46.8 at baseline to 46.0 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey.

Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group; the exceptions were nonsignificant, except for medication dosage, which declined for both groups, but far more so in the neurostimulation group (49% vs. 10%, respectively). Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups.

The investigators reported 13 adverse events–10 in the neurostimulation group and 3 in the medication-only group. Three patients in the neurostimulation group died, one as a result of a hematoma occurring during surgery, one from pneumonia, and one from suicide. A patient in the medication group died after driving during a psychotic episode.

The overall results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” Dr. Deuschl and colleagues cautioned.

ELSEVIER GLOBAL MEDICAL NEWS

GAITHERSBURG, MD. — A device intended for use in the annual breast cancer screening of women aged 30–39 years who have no family history of the disease and a negative clinical breast examination was found not effective in a unanimous vote by the Food and Drug Administration Obstetrics and Gynecology Devices Panel in August.

The T-Scan 2000ED is manufactured by Mirabel Medical Systems and uses a 1-volt electrical current to collect 306 measures of impedance for each breast. Mirabel believes differences in impedance can indicate the presence of cancer; women with positive results would then be referred for mammography or ultrasound. A positive T-Scan result is shown on the operator's monitor as a red line, and a negative result appears as a green line; no tissue imaging is produced.

A principal objection of the panel was that the sensitivity arm of the study included women aged 30–45 years, rather than just the 30–39 target age group included in the specificity arm. Moreover, both arms included clinical sites in Israel, where the population is dissimilar to that of the United States in ethnic makeup, body mass index, and possibly brassiere cup size and other factors, panel members noted.

The racial composition of both study arms also raised concerns; minority patients were underrepresented in comparison with the U.S. population, several panel members noted. In the specificity arm, 1.5% of the patients were of Asian descent, 2.9% were black, and 2.7% were Hispanic. In the sensitivity arm, 2.3% were Asian, 8% were black, and 4.6% were Hispanic.

The prospect of needlessly alarming patients with positive T-Scan results later belied by negative mammograms was raised by the panel. The FDA deduced from Mirabel's data that using a prevalence of 0.0015 in a population of 10,000 women, 530 would receive false positives. At the same time, T-Scan would identify 4 of 15 expected cancers in the group and miss roughly 11 cancers. Some panel members worried that false positives would lead to increased patient anxiety that might not be assuaged by negative mammogram testing. Specificity was calculated at 94.7.

Dr. Mark Akin, a private-practice gynecologist in Austin, Tex., and one of several physicians to use the device in clinical trials, believes any extra anxiety is minimal and worth the potential benefit. “Whatever level of anxiety [my patients] may have had, I'm certain that it pales in comparison with the devastation a woman in her 30s experiences when she is told she has advanced breast cancer and will never see her children grow up. What I saw in my study were young women who were grateful that I cared enough to test a new device in order to potentially find breast cancer when it was early enough to have a chance at cure,” he said in an interview. “Although the pooled data had a 95% specificity, out of my patients, I only had six positive findings. Statistically, [that] should have been 18. These T-Scan-positive patients were told they had a 99% chance of being normal. All six subsequently had a screening mammogram that was normal. I did not observe any more anxiety in these patients than when a patient has an abnormal Pap smear and goes on to have a normal colposcopy.

Also of concern to some panel members was the predetermined requirement of 2 for relative probability, meaning that any woman in the target age range with a positive T-Scan finding would need to be twice as likely to have breast cancer as the average woman in the 30- to 39-year-old population. Relative probability was ultimately determined to be 3.6. However, at least one panel member regarded the threshold of 2 as inappropriate. “I think the 2 hurdle is much too low. … It absolutely must be associated with age. A 30-year-old is incredibly different from a 39-year-old in terms of risk for breast cancer,” said Donald Berry, Ph.D., chairman of biostatistics and applied mathematics and director of cancer research at the University of Texas M.D. Anderson Cancer Center, Houston.

According to the FDA's analysis of the sensitivity trial, there were four confirmed cancers in women aged 30–39 who had negative clinical breast examination findings and negative family history of cancer. Two cases were in the United States, and two were in Israel, where one was detected by the T-Scan. An additional 11 cancers were confirmed in the 40–45 age group, of which 4 were detected by T-Scan. Thus the device detected 5 of 15 overall cancers and 1 of 4 cancers in women younger than 40, for a sensitivity rate of 25%, the FDA concluded.

“We have, at the maximum, 15 cancers and 5 assessments by T-Scan; this would establish a new low for the FDA in terms of level of evidence,” Dr. Berry said before the 10-0 vote.

Dr. Akin disagreed. He explained in an interview, “The T-Scan identifies 5% of the population that has a fivefold greater chance of breast cancer than the rest of the population. … Since mammogram screening starts at age 40 for the general population (solely based upon the age at which their risk exceeds 1 in 300–400), it makes sense to screen younger T-Scan-positive patients, whose risk is three times higher than [that of] a 40-year-old,” he said.

Other gynecologists also spoke in favor of approval in the public comments forum at the meeting. Dr. Steven Goldstein, professor of ob.gyn. at New York University, noted that whereas 12,000 women aged 30–39 are diagnosed with breast cancer each year, only 9,000 women total are diagnosed with cervical cancer annually. “For all the talk these days about HPV and vaccines, the cervical cancer success story is really the result of screening—the Pap smear.” Moreover, “Clinical use allows maturation and further refinement of virtually all medical technology, and I'm confident the same would be true of electrical impedance, if given the chance,” he added.

No panelists had concerns regarding the safety of the device. A previous version, the T-Scan 2000, was deemed safe and effective by the FDA in 1999 for clarification of equivocal mammographic findings.

Dr. Ron Ginor, the CEO of Mirabel, noted that an ongoing trial of a larger and more diverse population of women in the U.S. military is underway. “The bottom line is this: … We have to figure out how we're going to take the appropriate leap of faith or not take a leap of faith and remain with no technology,” Dr. Ginor said.

Dr. Akin echoed this sentiment. “Unfortunately, women aged 30–39 in the U.S. currently find their own breast cancers 71 percent of the time, frequently when the tumor is at an advanced stage and treatment is no longer going to prevent high morbidity or death.”

Dr. Berry, however, believes that even in 39-year-olds, breast cancer is too rare and the device's sensitivity too low to justify its approval. “Among 1,000 39-year-olds flagged by the T-Scan, 5 would have cancer,” he said in an interview. “About three times as many women (15) among the 19,000 that are not flagged would have undetected cancer. … We don't know that the 5 women identified as having cancers would actually benefit, but we know that 995 women without cancers will experience a variety of negative effects, from anxiety because of their positive test result to biopsies.

“There's a reason mammography is not recommended for women in their 30s: The disease is so rare that the negatives clearly outweigh the positives,” Dr. Berry said.

The FDA usually follows the recommendations of its advisory panels.

GAITHERSBURG, MD. — A device intended for use in the annual breast cancer screening of women aged 30–39 years who have no family history of the disease and a negative clinical breast examination was found not effective in a unanimous vote by the Food and Drug Administration Obstetrics and Gynecology Devices Panel in August.

The T-Scan 2000ED is manufactured by Mirabel Medical Systems and uses a 1-volt electrical current to collect 306 measures of impedance for each breast. Mirabel believes differences in impedance can indicate the presence of cancer; women with positive results would then be referred for mammography or ultrasound. A positive T-Scan result is shown on the operator's monitor as a red line, and a negative result appears as a green line; no tissue imaging is produced.

A principal objection of the panel was that the sensitivity arm of the study included women aged 30–45 years, rather than just the 30–39 target age group included in the specificity arm. Moreover, both arms included clinical sites in Israel, where the population is dissimilar to that of the United States in ethnic makeup, body mass index, and possibly brassiere cup size and other factors, panel members noted.

The racial composition of both study arms also raised concerns; minority patients were underrepresented in comparison with the U.S. population, several panel members noted. In the specificity arm, 1.5% of the patients were of Asian descent, 2.9% were black, and 2.7% were Hispanic. In the sensitivity arm, 2.3% were Asian, 8% were black, and 4.6% were Hispanic.

The prospect of needlessly alarming patients with positive T-Scan results later belied by negative mammograms was raised by the panel. The FDA deduced from Mirabel's data that using a prevalence of 0.0015 in a population of 10,000 women, 530 would receive false positives. At the same time, T-Scan would identify 4 of 15 expected cancers in the group and miss roughly 11 cancers. Some panel members worried that false positives would lead to increased patient anxiety that might not be assuaged by negative mammogram testing. Specificity was calculated at 94.7.

Dr. Mark Akin, a private-practice gynecologist in Austin, Tex., and one of several physicians to use the device in clinical trials, believes any extra anxiety is minimal and worth the potential benefit. “Whatever level of anxiety [my patients] may have had, I'm certain that it pales in comparison with the devastation a woman in her 30s experiences when she is told she has advanced breast cancer and will never see her children grow up. What I saw in my study were young women who were grateful that I cared enough to test a new device in order to potentially find breast cancer when it was early enough to have a chance at cure,” he said in an interview. “Although the pooled data had a 95% specificity, out of my patients, I only had six positive findings. Statistically, [that] should have been 18. These T-Scan-positive patients were told they had a 99% chance of being normal. All six subsequently had a screening mammogram that was normal. I did not observe any more anxiety in these patients than when a patient has an abnormal Pap smear and goes on to have a normal colposcopy.

Also of concern to some panel members was the predetermined requirement of 2 for relative probability, meaning that any woman in the target age range with a positive T-Scan finding would need to be twice as likely to have breast cancer as the average woman in the 30- to 39-year-old population. Relative probability was ultimately determined to be 3.6. However, at least one panel member regarded the threshold of 2 as inappropriate. “I think the 2 hurdle is much too low. … It absolutely must be associated with age. A 30-year-old is incredibly different from a 39-year-old in terms of risk for breast cancer,” said Donald Berry, Ph.D., chairman of biostatistics and applied mathematics and director of cancer research at the University of Texas M.D. Anderson Cancer Center, Houston.

According to the FDA's analysis of the sensitivity trial, there were four confirmed cancers in women aged 30–39 who had negative clinical breast examination findings and negative family history of cancer. Two cases were in the United States, and two were in Israel, where one was detected by the T-Scan. An additional 11 cancers were confirmed in the 40–45 age group, of which 4 were detected by T-Scan. Thus the device detected 5 of 15 overall cancers and 1 of 4 cancers in women younger than 40, for a sensitivity rate of 25%, the FDA concluded.

“We have, at the maximum, 15 cancers and 5 assessments by T-Scan; this would establish a new low for the FDA in terms of level of evidence,” Dr. Berry said before the 10-0 vote.

Dr. Akin disagreed. He explained in an interview, “The T-Scan identifies 5% of the population that has a fivefold greater chance of breast cancer than the rest of the population. … Since mammogram screening starts at age 40 for the general population (solely based upon the age at which their risk exceeds 1 in 300–400), it makes sense to screen younger T-Scan-positive patients, whose risk is three times higher than [that of] a 40-year-old,” he said.

Other gynecologists also spoke in favor of approval in the public comments forum at the meeting. Dr. Steven Goldstein, professor of ob.gyn. at New York University, noted that whereas 12,000 women aged 30–39 are diagnosed with breast cancer each year, only 9,000 women total are diagnosed with cervical cancer annually. “For all the talk these days about HPV and vaccines, the cervical cancer success story is really the result of screening—the Pap smear.” Moreover, “Clinical use allows maturation and further refinement of virtually all medical technology, and I'm confident the same would be true of electrical impedance, if given the chance,” he added.

No panelists had concerns regarding the safety of the device. A previous version, the T-Scan 2000, was deemed safe and effective by the FDA in 1999 for clarification of equivocal mammographic findings.

Dr. Ron Ginor, the CEO of Mirabel, noted that an ongoing trial of a larger and more diverse population of women in the U.S. military is underway. “The bottom line is this: … We have to figure out how we're going to take the appropriate leap of faith or not take a leap of faith and remain with no technology,” Dr. Ginor said.

Dr. Akin echoed this sentiment. “Unfortunately, women aged 30–39 in the U.S. currently find their own breast cancers 71 percent of the time, frequently when the tumor is at an advanced stage and treatment is no longer going to prevent high morbidity or death.”

Dr. Berry, however, believes that even in 39-year-olds, breast cancer is too rare and the device's sensitivity too low to justify its approval. “Among 1,000 39-year-olds flagged by the T-Scan, 5 would have cancer,” he said in an interview. “About three times as many women (15) among the 19,000 that are not flagged would have undetected cancer. … We don't know that the 5 women identified as having cancers would actually benefit, but we know that 995 women without cancers will experience a variety of negative effects, from anxiety because of their positive test result to biopsies.

“There's a reason mammography is not recommended for women in their 30s: The disease is so rare that the negatives clearly outweigh the positives,” Dr. Berry said.

The FDA usually follows the recommendations of its advisory panels.

GAITHERSBURG, MD. — A device intended for use in the annual breast cancer screening of women aged 30–39 years who have no family history of the disease and a negative clinical breast examination was found not effective in a unanimous vote by the Food and Drug Administration Obstetrics and Gynecology Devices Panel in August.

The T-Scan 2000ED is manufactured by Mirabel Medical Systems and uses a 1-volt electrical current to collect 306 measures of impedance for each breast. Mirabel believes differences in impedance can indicate the presence of cancer; women with positive results would then be referred for mammography or ultrasound. A positive T-Scan result is shown on the operator's monitor as a red line, and a negative result appears as a green line; no tissue imaging is produced.

A principal objection of the panel was that the sensitivity arm of the study included women aged 30–45 years, rather than just the 30–39 target age group included in the specificity arm. Moreover, both arms included clinical sites in Israel, where the population is dissimilar to that of the United States in ethnic makeup, body mass index, and possibly brassiere cup size and other factors, panel members noted.

The racial composition of both study arms also raised concerns; minority patients were underrepresented in comparison with the U.S. population, several panel members noted. In the specificity arm, 1.5% of the patients were of Asian descent, 2.9% were black, and 2.7% were Hispanic. In the sensitivity arm, 2.3% were Asian, 8% were black, and 4.6% were Hispanic.

The prospect of needlessly alarming patients with positive T-Scan results later belied by negative mammograms was raised by the panel. The FDA deduced from Mirabel's data that using a prevalence of 0.0015 in a population of 10,000 women, 530 would receive false positives. At the same time, T-Scan would identify 4 of 15 expected cancers in the group and miss roughly 11 cancers. Some panel members worried that false positives would lead to increased patient anxiety that might not be assuaged by negative mammogram testing. Specificity was calculated at 94.7.

Dr. Mark Akin, a private-practice gynecologist in Austin, Tex., and one of several physicians to use the device in clinical trials, believes any extra anxiety is minimal and worth the potential benefit. “Whatever level of anxiety [my patients] may have had, I'm certain that it pales in comparison with the devastation a woman in her 30s experiences when she is told she has advanced breast cancer and will never see her children grow up. What I saw in my study were young women who were grateful that I cared enough to test a new device in order to potentially find breast cancer when it was early enough to have a chance at cure,” he said in an interview. “Although the pooled data had a 95% specificity, out of my patients, I only had six positive findings. Statistically, [that] should have been 18. These T-Scan-positive patients were told they had a 99% chance of being normal. All six subsequently had a screening mammogram that was normal. I did not observe any more anxiety in these patients than when a patient has an abnormal Pap smear and goes on to have a normal colposcopy.

Also of concern to some panel members was the predetermined requirement of 2 for relative probability, meaning that any woman in the target age range with a positive T-Scan finding would need to be twice as likely to have breast cancer as the average woman in the 30- to 39-year-old population. Relative probability was ultimately determined to be 3.6. However, at least one panel member regarded the threshold of 2 as inappropriate. “I think the 2 hurdle is much too low. … It absolutely must be associated with age. A 30-year-old is incredibly different from a 39-year-old in terms of risk for breast cancer,” said Donald Berry, Ph.D., chairman of biostatistics and applied mathematics and director of cancer research at the University of Texas M.D. Anderson Cancer Center, Houston.

According to the FDA's analysis of the sensitivity trial, there were four confirmed cancers in women aged 30–39 who had negative clinical breast examination findings and negative family history of cancer. Two cases were in the United States, and two were in Israel, where one was detected by the T-Scan. An additional 11 cancers were confirmed in the 40–45 age group, of which 4 were detected by T-Scan. Thus the device detected 5 of 15 overall cancers and 1 of 4 cancers in women younger than 40, for a sensitivity rate of 25%, the FDA concluded.

“We have, at the maximum, 15 cancers and 5 assessments by T-Scan; this would establish a new low for the FDA in terms of level of evidence,” Dr. Berry said before the 10-0 vote.

Dr. Akin disagreed. He explained in an interview, “The T-Scan identifies 5% of the population that has a fivefold greater chance of breast cancer than the rest of the population. … Since mammogram screening starts at age 40 for the general population (solely based upon the age at which their risk exceeds 1 in 300–400), it makes sense to screen younger T-Scan-positive patients, whose risk is three times higher than [that of] a 40-year-old,” he said.

Other gynecologists also spoke in favor of approval in the public comments forum at the meeting. Dr. Steven Goldstein, professor of ob.gyn. at New York University, noted that whereas 12,000 women aged 30–39 are diagnosed with breast cancer each year, only 9,000 women total are diagnosed with cervical cancer annually. “For all the talk these days about HPV and vaccines, the cervical cancer success story is really the result of screening—the Pap smear.” Moreover, “Clinical use allows maturation and further refinement of virtually all medical technology, and I'm confident the same would be true of electrical impedance, if given the chance,” he added.

No panelists had concerns regarding the safety of the device. A previous version, the T-Scan 2000, was deemed safe and effective by the FDA in 1999 for clarification of equivocal mammographic findings.

Dr. Ron Ginor, the CEO of Mirabel, noted that an ongoing trial of a larger and more diverse population of women in the U.S. military is underway. “The bottom line is this: … We have to figure out how we're going to take the appropriate leap of faith or not take a leap of faith and remain with no technology,” Dr. Ginor said.

Dr. Akin echoed this sentiment. “Unfortunately, women aged 30–39 in the U.S. currently find their own breast cancers 71 percent of the time, frequently when the tumor is at an advanced stage and treatment is no longer going to prevent high morbidity or death.”

Dr. Berry, however, believes that even in 39-year-olds, breast cancer is too rare and the device's sensitivity too low to justify its approval. “Among 1,000 39-year-olds flagged by the T-Scan, 5 would have cancer,” he said in an interview. “About three times as many women (15) among the 19,000 that are not flagged would have undetected cancer. … We don't know that the 5 women identified as having cancers would actually benefit, but we know that 995 women without cancers will experience a variety of negative effects, from anxiety because of their positive test result to biopsies.

“There's a reason mammography is not recommended for women in their 30s: The disease is so rare that the negatives clearly outweigh the positives,” Dr. Berry said.

The FDA usually follows the recommendations of its advisory panels.