By Sharon Begley

NEW YORK |
Mon May 21, 2012 11:09pm EDT

NEW YORK (Reuters) – A task force advising the U.S. government on Monday recommended against routine use of the prostate-cancer screening test called PSA, or prostate specific antigen, for lack of a discernible health benefit.

Like a draft proposal last October, the U.S. Preventive Services Task Force gave PSA screening a D, for “don’t recommend” in healthy men.

The reaction was fast and furious. Screening advocates warned that the recommendation will cost lives, but critics of PSA testing said thousands of men will be spared impotence and incontinence as a result of needless cancer treatment.

A D means there is “moderate or high certainty” that a procedure has no net benefit or that harms outweigh benefits. It is a downgrade from the panel’s last PSA recommendation, in 2008, which said the evidence was insufficient to assess the procedure’s risks and benefits, although PSA screening for men 75 and older was not recommended.

Now, however, “there is convincing evidence that the number of men who avoid dying of prostate cancer because of screening after 10 to 14 years is, at best, very small,” the task force said in the May 22 issue of the Annals of Internal Medicine. Doctors, therefore, should discourage it.

The recommendation does not preclude men from asking for PSA screening, or doctors from offering it. But it could affect whether insurers, including the government’s Medicare program, cover the test’s $60 to $80 cost.

The only other screening method is the old-fashioned digital rectal exam, which cannot detect small, early cancers. Neither the exam nor PSA can distinguish slow-growing from aggressive cancers.

About one in six American men will be diagnosed with prostate cancer during his life; 2.8 percent, or a projected 28,000 this year, will die of it. Many cases pose no risk even without treatment. Research has shown that between one-quarter and one-third of 60-something men have prostate cancer, often without knowing it. Three-quarters of men older than 85 years have prostate cancer but few die of it.

PSA, a blood test, is a poor screening tool because PSA levels can rise for reasons unrelated to cancer, including age and prostate enlargement. Yet an elevated PSA level can trigger a biopsy to check for cancer.

Most biopsies show no cancer, which means the PSA was a false positive. But prostate biopsies that detect cancer do so based on research from the 1840s, explained Dr. Otis Brawley, chief medical officer of the American Cancer Society.

“As many as 70 percent of these lesions are cancer only by this antiquated definition and not in behavior,” he said. That is, they are indolent or inert and will not threaten a man’s health or life.

Radiation oncologist Anthony D’Amico of Dana-Farber Cancer Institute in Boston acknowledges that PSA screening causes overdiagnosis, “but if you get rid of the PSA test, men will suffer and die of prostate cancer,” he said.

“I’m shocked that they would let people die in order to avoid incontinence and erectile dysfunction, which can be corrected.”

CONFLICTING STUDIES

The task force analyzed 64 studies, but focused on two, both published in 2009 and updated this year.

The U.S. study compared 76,685 men aged 55 to 74. About half were assigned to receive annual PSA screening and half to “usual care,” which sometimes included a PSA test. The study found no evidence that PSA screening saved lives after 13 years.

The European study was similar, with about half of 162,243 men aged 55 to 69 getting regular PSA tests and half not. But for every 1,055 men who were screened every one to four years, there was one fewer death from prostate cancer after 11 years compared to men in the unscreened group. That is the basis for the task force’s conclusion that PSA screening for a decade will prevent at most one man in 1,000 from dying of prostate cancer.

The trials themselves were imperfect, polarizing the debate even further.

The American trial was marred by the fact that some men in the “unscreened, usual care” group did receive PSA tests. Such so-called crossovers can weaken a trial’s conclusions.

“With the rate of screening in the ‘unscreened arm’ matching that in the ‘screened’ arm, you can never measure a difference” in the death rates “even if one exists,” said D’Amico.

The trial scientists disagreed, saying the crossovers were statistically equivalent to having fewer people in the trial, said biostatistician Paul Pinsky of the National Cancer Institute, a member of the study team. “But there was twice as much screening in the intervention arm, and we did not find a mortality benefit.”

The European study is actually seven studies, each from one country. In five, the results mimicked the American findings: no statistically significant reduction in deaths from prostate cancer among screened men. But studies from Sweden and the Netherlands showed benefits.

The European scientists and their supporters argued that the Swedish trial in particular was strong enough to stand on its own as evidence that PSA screening saves lives.

Perhaps the greatest problem with the European study is that the screened men diagnosed with prostate cancer generally received top-of-the-line care from academic physicians. If the unscreened men developed prostate cancer, they received less specialized, less aggressive care. “That means this was a trial not only of PSA screening but also of aggressive vs. non-aggressive treatment,” said Brawley.

WEIGHING HARMS

Against the tiny benefit of PSA testing, the task force weighed its harms. At least 15 percent of PSA tests will trigger a biopsy, after which up to one-third of men experience pain, fever, bleeding, infection, difficulty urinating, or other problems requiring medical attention, studies show.

If a biopsy finds seemingly malignant cells, as happens to 120 in 1,000 screened men, about 90 percent of men opt for surgery, radiation or hormone-deprivation therapy. Up to five men in 1,000 opting for surgery will die within a month of the operation; 10 to 70 more will have serious cardiovascular complications such as a stroke or heart attack.

After radiotherapy and surgery, 200 to 300 of 1,000 men suffer incontinence, impotence or both. Hormone-deprivation therapy causes erectile dysfunction in about 400 of 1,000 men.

“When you stack up those harms, the tiny or zero benefits do not outweigh the risk,” said task force co-chair Dr. Michael LeFevre of the University of Missouri Medical School. Because PSA tests cannot distinguish between aggressive and indolent cancer, said ACS’s Brawley, “men are rendered impotent and put in diapers, and for what?” he asked. “They never really had cancer in the first place.”

The task force is not saying no man of any age under any circumstances should undergo PSA screening. “A D recommendation does not preclude discussions between clinicians and patients to promote informed decision making that supports personal values and preferences,” it said. The recommendation is against routine screening.

“Our recommendation should not preclude a physician offering a PSA test or a man requesting it,” said co-chair LeFevre. He would be glad to provide the test for his patients, he said, if the decision were based on a clear understanding of the possible benefits and harms. ACS’s Brawley agrees that “a fully-informed man who wants to be screened in his doctor’s office should be screened.” Only if physicians are prepared to explain all this, including that PSA screening misses just as many cancers as it finds, said the task force, can men make an informed choice.

Experts on both sides do agree that mass free screenings offered by hundreds of urology clinics and hospitals should end. “There is minimal discussion of risks and benefits; a pamphlet isn’t going to do it,” said D’Amico. “But a lot of fear gets invoked.”

(Reporting By Sharon Begley; Editing by Michele Gershberg and Cynthia Osterman)

Related posts:

1. U.S. task force: End routine prostate cancer screening
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3. New data fuel debate over prostate cancer screening

By Kate Kelland

LONDON |
Mon May 21, 2012 7:04pm EDT

LONDON (Reuters) – Low-quality and fake anti-malarial drugs flooding into markets in Asia and Africa are driving drug resistance and threatening gains made in the fight against the disease in the past decade, according to a study by global health experts.

The study found around 36 percent of anti-malarial drugs analyzed in southeast Asia were fake, while a third of samples in sub-Saharan Africa failed chemical testing because they contained either too much or not enough active ingredient.

The researchers said the problem might be even bigger.

The emergence of resistance to artemisinin drugs – currently the most effective treatment for malaria – along the Thailand-Cambodia border – has already been documented.

“Despite a dramatic rise in reports of poor-quality anti- malarial drugs over the past decade, the issue is much greater than it seems,” Gaurvika Nayyar, of the Fogarty International Center at the U.S. National Institutes of Health, wrote in a study in the Lancet Infectious Diseases journal.

“Most cases are probably unreported, reported to the wrong agencies, or kept confidential by pharmaceutical companies.”

More than 3 billion people worldwide are at risk of malaria, a mosquito-borne parasitic disease which kills around 650,000 people a year, most of them babies and children in Africa.

Nayyar said many of the deaths caused by the disease could be avoided “if drugs available to patients were efficacious, high quality, and used correctly.”

The World Health Organisation (WHO) estimates that while less than 1 percent of medicines available in developed countries are likely to be counterfeit, globally, the figure is around 10 percent.

The United Nations agency estimates that as much as a third of all medicines in some developing countries is fake.

As well as putting patients at risk, counterfeit drugs are a constant bane for companies like GlaxoSmithkline, Sanofi and other international drugmakers.

Nayyar’s team analyzed data from both published and unpublished studies that looked at chemical analyses and the packaging of malaria medicines in sub-Saharan Africa and southeast Asia where the malaria risk is highest.

Data from seven countries in southeast Asia – including from analysis of 1,437 samples of seven different malaria drugs – showed that more than a third of them failed chemical testing, nearly half were wrongly packaged, and about a third were bogus.

Analysis of data from 21 countries in sub-Saharan Africa including more than 2,500 drug samples, showed similar results, with more than a third failing chemical testing and around one fifth turning out to be fake.

(Editing by Robin Pomeroy)

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By Terry Baynes

Mon May 21, 2012 6:53pm EDT

(Reuters) – The University of Notre Dame and dozens of other Catholic institutions sued President Barack Obama’s administration on Monday to block a government regulation that requires employers to provide health insurance coverage for contraceptives to employees.

The regulation, which is part of the president’s healthcare reform law, has sparked a nasty fight between the administration and the Roman Catholic Church, which opposes artificial contraception.

Some 43 Catholic groups including Notre Dame, Catholic University of America and the Archdiocese of New York filed 12 different suits across the country.

The organizations accuse the federal government of forcing them to support contraception, sterilization and birth control in violation of their religious beliefs or face steep fines.

The original law exempted churches and other houses of worship from covering contraception on the basis of religious objections. But it did not carve out an exception for religious nonprofits, such as hospitals, charities and schools, sparking an outcry from church leaders.

As a compromise, Obama scaled back the controversial healthcare rule in February, announcing that insurance companies would cover the cost of the birth control for religious employers. But the complaints filed on Monday said the accommodation did not go far enough.

“In order to safeguard their religious freedoms, religious employers must plead with the government for a determination that they are sufficiently ‘religious,’” Notre Dame said in its lawsuit, filed in Indiana federal court.

Under the revised mandate, religious organizations can only qualify for the exemption if their purpose is to spread their religious beliefs. They must also primarily employ and serve people with the same religious values.

Such government scrutiny violates the separation between church and state, the suits claim. Notre Dame’s complaint said it was unclear whether the school could qualify for the exemption, given its commitment to employ and serve people of all faiths.

Jane Belford, chancellor of the Archdiocese of Washington which joined one suit, said the groups aimed to challenge the government’s redefinition of religion.

“While this mandate paid lip service to the rights of conscience and religious liberty, it created a definition that was so narrow, even the work of Mother Theresa would not have qualified as religious,” Belford said.

The Department of Health and Human Services declined to comment on the litigation.

The U.S. Conference of Catholic Bishops, although it did not join any of the suits, praised the individual dioceses, charities and schools for defending religious liberty.

At least 11 other lawsuits have previously been filed against the contraceptive mandate, according to comments that the U.S. Conference of Catholic Bishops submitted to the Department of Health and Human Services on May 15. The submission included a warning about Monday’s lawsuits: “Absent prompt congressional attention to this infringement on fundamental civil liberties, we believe the only remaining recourse … is in the courts.”

Jennifer Dalven, a lawyer at the American Civil Liberties Union, said the mandate was not new. Twenty-eight states have laws requiring insurers to cover birth control to the same extent as other medications.

“The lawsuits make it seem like taking a job is the same as joining a church. But organizations that participate in the public sphere are supposed to abide by public rules,” Dalven said.

The suits were filed around the country, including in the District of Columbia, New York, Mississippi and Texas, according to Jones Day.

(Reporting By Terry Baynes; Editing by Greg McCune and Eric Walsh)

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3. White House sticking to contraception plan

By Sharon Begley

NEW YORK |
Mon May 21, 2012 6:10pm EDT

NEW YORK (Reuters) – A task force advising the U.S. government on Monday recommended against routine use of the prostate-cancer screening test called PSA, or prostate specific antigen, for lack of a discernible health benefit.

Like a draft proposal last October, the U.S. Preventive Services Task Force gave PSA screening a D, for “don’t recommend” in healthy men.

The reaction was fast and furious. Screening advocates warned that the recommendation will cost lives, but critics of PSA testing said thousands of men will be spared impotence and incontinence as a result of needless cancer treatment.

A D means there is “moderate or high certainty” that a procedure has no net benefit or that harms outweigh benefits. It is a downgrade from the panel’s last PSA recommendation, in 2008, which said the evidence was insufficient to assess the procedure’s risks and benefits, although PSA screening for men 75 and older was not recommended.

Now, however, “there is convincing evidence that the number of men who avoid dying of prostate cancer because of screening after 10 to 14 years is, at best, very small,” the task force said in the May 22 issue of the Annals of Internal Medicine. Doctors, therefore, should discourage it.

The recommendation does not preclude men from asking for PSA screening, or doctors from offering it. But it could affect whether insurers, including the government’s Medicare program, cover the test’s $60 to $80 cost.

The only other screening method is the old-fashioned digital rectal exam, which cannot detect small, early cancers. Neither the exam nor PSA can distinguish slow-growing from aggressive cancers.

About one in six American men will be diagnosed with prostate cancer during his life; 2.8 percent, or a projected 28,000 this year, will die of it. Many cases pose no risk even without treatment. Research has shown that between one-quarter and one-third of 60-something men have prostate cancer, often without knowing it. Three-quarters of men older than 85 years have prostate cancer but few die of it.

PSA, a blood test, is a poor screening tool because PSA levels can rise for reasons unrelated to cancer, including age and prostate enlargement. Yet an elevated PSA level can trigger a biopsy to check for cancer.

Most biopsies show no cancer, which means the PSA was a false positive. But prostate biopsies that detect cancer do so based on research from the 1840s, explained Dr. Otis Brawley, chief medical officer of the American Cancer Society.

“As many as 70 percent of these lesions are cancer only by this antiquated definition and not in behavior,” he said. That is, they are indolent or inert and will not threaten a man’s health or life.

Radiation oncologist Anthony D’Amico of Dana-Farber Cancer Institute in Boston acknowledges that PSA screening causes overdiagnosis, “but if you get rid of the PSA test, men will suffer and die of prostate cancer,” he said.

“I’m shocked that they would let people die in order to avoid incontinence and erectile dysfunction, which can be corrected.”

CONFLICTING STUDIES

The task force analyzed 64 studies, but focused on two, both published in 2009 and updated this year.

The U.S. study compared 76,685 men aged 55 to 74. About half were assigned to receive annual PSA screening and half to “usual care,” which sometimes included a PSA test. The study found no evidence that PSA screening saved lives after 13 years.

The European study was similar, with about half of 162,243 men aged 55 to 69 getting regular PSA tests and half not. But for every 1,055 men who were screened every one to four years, there was one fewer death from prostate cancer after 11 years compared to men in the unscreened group. That is the basis for the task force’s conclusion that PSA screening for a decade will prevent at most one man in 1,000 from dying of prostate cancer.

The trials themselves were imperfect, polarizing the debate even further.

The American trial was marred by the fact that some men in the “unscreened, usual care” group did receive PSA tests. Such so-called crossovers can weaken a trial’s conclusions.

“With the rate of screening in the ‘unscreened arm’ matching that in the ‘screened’ arm, you can never measure a difference” in the death rates “even if one exists,” said D’Amico.

The trial scientists disagreed, saying the crossovers were statistically equivalent to having fewer people in the trial, said biostatistician Paul Pinsky of the National Cancer Institute, a member of the study team. “But there was twice as much screening in the intervention arm, and we did not find a mortality benefit.”

The European study is actually seven studies, each from one country. In five, the results mimicked the American findings: no statistically significant reduction in deaths from prostate cancer among screened men. But studies from Sweden and the Netherlands showed benefits.

The European scientists and their supporters argued that the Swedish trial in particular was strong enough to stand on its own as evidence that PSA screening saves lives.

Perhaps the greatest problem with the European study is that the screened men diagnosed with prostate cancer generally received top-of-the-line care from academic physicians. If the unscreened men developed prostate cancer, they received less specialized, less aggressive care. “That means this was a trial not only of PSA screening but also of aggressive vs. non-aggressive treatment,” said Brawley.

WEIGHING HARMS

Against the tiny benefit of PSA testing, the task force weighed its harms. At least 15 percent of PSA tests will trigger a biopsy, after which up to one-third of men experience pain, fever, bleeding, infection, difficulty urinating, or other problems requiring medical attention, studies show.

If a biopsy finds seemingly malignant cells, as happens to 120 in 1,000 screened men, about 90 percent of men opt for surgery, radiation or hormone-deprivation therapy. Up to five men in 1,000 opting for surgery will die within a month of the operation; 10 to 70 more will have serious cardiovascular complications such as a stroke or heart attack.

After radiotherapy and surgery, 200 to 300 of 1,000 men suffer incontinence, impotence or both. Hormone-deprivation therapy causes erectile dysfunction in about 400 of 1,000 men.

“When you stack up those harms, the tiny or zero benefits do not outweigh the risk,” said task force co-chair Dr. Michael LeFevre of the University of Missouri Medical School. Because PSA tests cannot distinguish between aggressive and indolent cancer, said ACS’s Brawley, “men are rendered impotent and put in diapers, and for what?” he asked. “They never really had cancer in the first place.”

The task force is not saying no man of any age under any circumstances should undergo PSA screening. “A D recommendation does not preclude discussions between clinicians and patients to promote informed decision making that supports personal values and preferences,” it said. The recommendation is against routine screening.

“Our recommendation should not preclude a physician offering a PSA test or a man requesting it,” said co-chair LeFevre. He would be glad to provide the test for his patients, he said, if the decision were based on a clear understanding of the possible benefits and harms. ACS’s Brawley agrees that “a fully-informed man who wants to be screened in his doctor’s office should be screened.” Only if physicians are prepared to explain all this, including that PSA screening misses just as many cancers as it finds, said the task force, can men make an informed choice.

Experts on both sides do agree that mass free screenings offered by hundreds of urology clinics and hospitals should end. “There is minimal discussion of risks and benefits; a pamphlet isn’t going to do it,” said D’Amico. “But a lot of fear gets invoked.”

(Reporting By Sharon Begley; Editing by Michele Gershberg and Cynthia Osterman)

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1. Study finds prostate screening cuts cancer deaths
2. New data fuel debate over prostate cancer screening
3. No support for routine pancreatic cancer screening

By Andrew M. Seaman

NEW YORK |
Mon May 21, 2012 5:37pm EDT

NEW YORK (Reuters Health) – A small study suggests surgeons in training are still tired enough to raise their risk of making significant errors, despite new guidelines limiting their work hours.

Researchers found that orthopedic surgical residents at two Boston-area hospitals were averaging five and a half hours of sleep a night, and so fatigued during waking hours that a quarter of the time their “impairment” was equivalent to being legally drunk.

The study was conducted in 2010 and throughout most of 2011, and while it was underway rules limiting the work hours of the novice surgeons were enacted by a graduate medical education body. But they may not be enough, researchers agreed.

“I think that this study suggests that it’s more than just regulatory changes,” said Dr. Frank McCormick, of the Harvard Combined Orthopaedic Residency Program in Boston and lead author of the new study.

McCormick and his colleagues focused on identifying when during a resident’s waking hours they were most impaired by fatigue.

Knowing when surgical residents are most likely to be dangerously tired, the group explains in the Archives of Surgery, may help to target interventions that could prevent medical mistakes.

For their study, McCormick and his fellow researchers analyzed information collected from 27 orthopedic residents at Massachusetts General Hospital and Brigham And Women’s Hospital.

At the outset, each resident was asked about his or her sleep and exercise habits and use of sedatives, alcohol and other stimulants.

The residents also kept daily sleep and work logs for two weeks while they wore a special “actigraphy” wristwatch that recorded movements to gauge the person’s activity level.

Overall, residents got an average of 5.3 hours of sleep per day — though the amount of sleep each resident got ranged widely, from 2.8 hours to 7.8 hours.

Based on the activity recordings, the researchers also determined that — compared to data on a group of well-rested residents — the study participants were only functioning at about 70 percent of their mental effectiveness during 27 percent of the time they were awake.

According to the researchers, 70 percent mental effectiveness is equivalent to having a 0.08 blood alcohol level, which is considered legally drunk in most states.

Based on that level of fatigue, McCormick and colleagues calculated the residents had a 22 percent greater risk of causing a medical error than alert, well rested doctors.

“Fatigue was higher than we expected, especially within specific subgroups,” said McCormick.

For nearly half their waking hours — 48 percent — the residents were mentally fatigued, but functioning above the 70 percent level.

In general, night-shift workers were worse off than the day-shift workers.

Residents working nights slept on average about 5.1 hours a day and functioned at less than 70 percent of their mental effectiveness 32 percent of their time awake.

Residents on day shifts slept about 5.7 hours and functioned at or below 70 percent effectiveness 17 percent of the time.

Day shift residents had a projected 19 percent increase in their risk of making a medical error, while night shift residents had a 24 percent increased risk.

McCormick cautioned, however, that these risks of medical error are only predictions based on fatigue level. The researchers did not assess how many medical errors were actually caused by tired surgical residents in the study.

As a result, “It’s difficult to actually quantify the amount of medical error that we’re preventing,” he told Reuters Health.

The study had other limitations as well, the authors note. Only 40 percent of the orthopedic residents at the two hospitals completed the study. And the researchers are not sure to what degree their findings can be applied to other types of medical residents.

In the same journal, Dr. Thomas Tracy Jr. of Hasbro Children’s Hospital and Brown University in Providence, R.I. wrote in an editorial that discovering surgical residents are fatigued during certain periods “is not startling” but its pervasiveness is “a finding we simply cannot avoid and may have paid lip service to in the past.”

Last July, the Accreditation Council for Graduate Medical Education, the body that oversees resident training, enacted new rules stating that first-year residents should work no more than 16 hours straight. The rules did not impact more experienced residents, however. They are allowed to work 28-hour shifts.

The Institute of Medicine estimates the rules would cost close to $1.7 billion dollars to implement — costs stemming mostly from hiring additional staff.

McCormick suggested targeting tired residents for preventive interventions may be more cost effective, and he said there have already been changes at the hospitals involved in the study.

“We’re currently switching around our schedule, eliminating our night flow and continuing to monitor fatigue,” he told Reuters Health.

SOURCE: bit.ly/Js9sYe Archives of Surgery, online May 21, 2012.

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By Genevra Pittman

NEW YORK |
Mon May 21, 2012 4:37pm EDT

NEW YORK (Reuters Health) – New recommendations from chest and cancer doctors call for lung cancer screening in older adults with a long history of smoking a pack a day or more — but also highlight the possible harms of screening, including a high risk of false positive tests.

The guidelines are based on a review of past studies which compared long-term health in smokers who underwent low-dose CT screening for lung cancer and those who got another cancer test or “usual care” instead.

Most of the evidence in favor of screening comes from a single large study known as the National Lung Screening Trial. That study found a 20-percent lower risk of lung cancer death among more than 26,000 people screened with low-dose CT annually for three years, compared to those who were tested with so-called chest radiographs instead.

But the combined prior research also suggested that in any round of CT screening, about one in five people will have positive results that require further testing, sometimes with invasive procedures — although only one percent will actually have lung cancer.

“The trade-offs there are sizeable, even in the high-risk people,” said Dr. Peter Bach, the lead author of the new review paper from Memorial Sloan-Kettering Cancer Center in New York.

“As you go down the risk range — younger people, people who have smoked less — because their chance of ever developing lung cancer is lower, the chance that they will benefit is also lower, and in some cases substantially lower,” he told Reuters Health.

According to the new recommendations from the American College of Chest Physicians and the American Society of Clinical Oncology, annual screening should be offered to current and former smokers, age 55 to 74, who have smoked at least a pack of cigarettes a day for 30 years.

The screening recommendations don’t apply to former smokers who quit more than 15 years ago, the researchers reported Sunday in the Journal of the American Medical Association.

Possible harms of lung cancer screening, they said, include the radiation associated with CT scans — which over long periods of time may increase the risk of cancer itself — as well as the unnecessary extra procedures and anxiety that come with a positive test that turns out to be a benign nodule.

Dr. James Mulshine, a lung cancer researcher at Rush Medical College in Chicago, said the new study may overplay the risks of screening compared to the benefits of catching potentially-deadly lung cancers early.

Currently, most lung cancers aren’t caught until stage III or IV, and less than one in five people with a new diagnosis survives five years.

“Lung cancer screening is a big deal,” Mulshine, also the vice president for research at Rush, told Reuters Health.

“Some people potentially will be harmed, and there’s even the chance some people will die (because of complications from screening). But that’s also the case of flu shots… and driving to the doctor’s office.”

He also suggested CT scans and other procedures are becoming safer over time, lowering the chance of screening-related harm.

Mulshine, who wasn’t involved in the new study, said it’s “very reasonable” for current or former heavy smokers to have a discussion with their doctors about the benefits and risks of lung cancer screening.

And any screening that is done, he said, should be combined with advice on how to quit smoking and referrals to smoking cessation programs for people who haven’t yet kicked the habit.

‘NOT A NO-BRAINER’

According to the Centers for Disease Control and Prevention, close to 160,000 people in the United States died from lung cancer in 2008, the most recent year with available data. Nationally, more men and women die from lung cancer than any other type of cancer.

Screening for lung cancer nodules runs about $300.

One of the original studies suggesting CT scans could prevent deaths from lung cancer was later criticized over ethical issues with how the research was conducted.

Since then, the National Lung Screening Trial has been the largest gold-standard study to evaluate low-dose CT screening — and the only one to convincingly show a benefit, the researchers reported. Two smaller studies analyzed by Bach and his colleagues included fewer than 5,000 participants each and didn’t find any difference in deaths with screening.

Bach said most people who get screened for lung cancer won’t benefit from it — because they don’t have cancer — and also won’t suffer any side effects.

People at high risk of cancer, he said, should “weigh the benefits and risks” of screening based both on their own chance of cancer and their values.

“This is not a no-brainer in any sense,” Bach said.

“We think on balance it’s worth it enough that it would be a reasonable decision for an individual (at high risk) to be screened, but I think different people value the risks and benefits differently.”

SOURCE: bit.ly/LuIyzk Journal of the American Medical Association, online May 20, 2012.

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By Kerry Grens

NEW YORK |
Mon May 21, 2012 3:47pm EDT

NEW YORK (Reuters Health) – Among hospital intensive care units (ICUs) with a daytime physician specially trained in critical care, adding a specialist to cover the night shift does not improve patients’ survival, according to a new study.

Among hospitals with ICUs that don’t have a dedicated critical care physician during the day, however, the presence of such a doctor at night was tied to a smaller likelihood that patients would die.

The results, published in the New England Journal of Medicine, counter an argument from some in the medical community that ICUs need round-the-clock intensivists — doctors who specialize in critical care.

“Our knee jerk reaction is to try to put intensivists in every ICU at all hours of the day, and that reaction is likely a misstep because it oversimplifies the issue,” said Dr. Jeremy Kahn, senior author of the study and a professor at the University of Pittsburgh School of Medicine.

Most research has shown that having an intensivist in an ICU during the day improves the chances that patients will survive, said Kahn.

“There’s been this movement to say, ‘well, we need to be there at night too,’” said Dr. Allan Garland, a professor at the University of Manitoba in Winnipeg, Canada, who was not involved in the study. “But what there hasn’t been is much data.”

Data are important when it comes to staffing ICUs, considering there are not enough intensivists to go around and they are a much more expensive staff member than, say, a nurse.

Kahn said just half of all ICUs in the United States have access to a critical care specialist.

And several earlier studies on the impact of nighttime intensivists have had mixed results.

To try to get a clearer picture of how much they help patients survive, Kahn’s group examined a larger group of ICUs.

They collected information from 49 ICUs across the U.S., covering more than 65,000 patients.

Twelve of the ICUs had an intensivist on staff at night, while the other 37 did not.

About 13 out of every 100 patients in the ICUs died within the hospital or went from the ICU to hospice care, regardless of whether there was an intensivist available at night or not.

But when the researchers divided the ICUs into two categories — those that had intensivists overseeing patient care during the day, and those that did not — Kahn’s group got a different answer.

Among the 22 ICUs with no intensivist during the day, having one at night was tied to a 38 percent lower patient death rate than in ICUs without a day- or nighttime intensivist.

“The results of this large study seem to support previously observed associations between overall ‘higher intensity staffing’ and lower mortality,” said Dr. Ognjen Gajic, a professor at the Mayo Clinic in Rochester, MN, who did not participate in this research.

Not all studies have agreed on this association, Gajic added in an email to Reuters Health.

Despite the new report’s finding that a nighttime intensivist makes a difference if there’s none during the day, the converse was not true: Among ICUs with an intensivist during the day, the percentage of patients who died within the hospital was the same regardless of whether an intensivist was also present at night.

Kahn said the findings suggest that the good intensivists do during the day carries over into the night.

It’s not so much that the benefits are coming from emergency, life-saving procedures in the wee hours, he explained.

Rather, the difference intensivists make comes from “much more routine, banal, systematic things, like high quality preventive medicine, ventilator management, and most of these things can be done effectively during the day. And once you’ve implemented all the evidenced-based practices during the day, then what you do at night has little impact,” said Kahn.

Gajic said it’s possible the ICUs that have intensivists on staff during the day might also have access to those doctors at night, because they are on call.

But without knowing the particular arrangements at each hospital, it’s unclear why ICUs with daytime intensivists don’t benefit from having them at night, he said.

Garland said there’s a need for more research on different staffing scenarios.

“One of the things that we would like to see is a consensus. You’re much more confident of a result when you’ve had different studies…all give you the same answer. I think it’s fair to say that we don’t (yet) have that with respect to how intensivists should be involved in ICUs,” Garland told Reuters Health.

Kahn said there might be legitimate reasons to have a nighttime specialist in the ICU, such as for training purposes.

But to improve the chances that patients will leave the ICU alive, it doesn’t appear that every ICU needs an intensivist at all hours.

“For ICUs that have very robust daytime staffing, they should seriously reexamine the reasons that they’re moving towards 24-hour intensivists, because it appears that there’s little if any marginal gain in survival, and those resources may be better deployed in other hospitals,” Kahn told Reuters Health.

SOURCE: bit.ly/JeFemx New England Journal of Medicine, online May 21, 2012.

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By David Beasley

ATLANTA |
Mon May 21, 2012 1:18pm EDT

ATLANTA (Reuters) – A Georgia graduate student fighting a rare flesh-eating bacterial infection she contracted after being injured in a zip-line accident nearly three weeks ago is breathing on her own without the help of a ventilator, her father said.

The struggle to save 24-year-old Aimee Copeland from necrotizing fasciitis – a bacterial infection that can destroy muscles, skin and tissue – has been chronicled by her father, Andy Copeland, in a blog on the university’s website.

“She has been off of the ventilator for over 10 hours,” Andy Copeland wrote late on Sunday. “In other words, she is breathing completely on her own! How cool is that?”

Copeland, a student at West Georgia University, slashed her calf when the zip-line snapped May 1 along the Little Tallapoosa River near Carrollton, Georgia. Emergency room doctors closed the wound with 22 staples and released Copeland, but she was diagnosed with the infection after her conditioned worsened.

Surgeons amputated Copeland’s left leg at the hip. Last week, she mouthed, “Let’s do this” when told her hands and remaining foot would have to be amputated, her father wrote on Friday.

It is unclear from Andy Copeland’s postings whether the additional amputations had already occurred. A hospital spokeswoman has declined to comment on the woman’s condition.

In his Sunday night posting, Andy Copeland said he was reducing the time he spends on media interviews.

“Two of my most important responsibilities are to pray for and provide financial support for my family,” he wrote. “Everything else, including blog posting, organizing blood drives and conducting media interviews is secondary.”

Different bacteria can cause necrotizing fasciitis. Health experts say the “flesh-eating” infection is not communicable.

Two cases of flesh-eating infections have been reported recently in South Carolina as well.

A new mother of twins, Lana Kuykendall, 36, was admitted to Greenville Memorial Hospital on May 11, days after giving birth, with a painful spot on her leg that was ultimately diagnosed as necrotizing fasciitis.

Her brother, Brian Swaffer, said Kuykendall had undergone at least seven operations, was sedated, and only opened her eyes “a little bit, at times.”

A former South Carolina fire chief, Glenn Pace, told a local television station he had been battling a flesh-eating bacteria since early April and had three surgeries on his foot.

A 1996 report from the U.S. Centers for Disease Control and Prevention estimated there were 500 to 1,500 cases of necrotizing fasciitis annually in the United States, with about 20 percent of them fatal. The National Necrotizing Fasciitis Foundation has said that estimate is probably low.

(Reporting by David Beasley and Harriet McLeod; Editing by Cynthia Johnston)

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By Amy Norton NEW YORK |
Mon May 21, 2012 1:11pm EDT

By Amy Norton NEW YORK (Reuters Health) – The percentage of U.S. teenagers with “pre-diabetes” or full-blown type 2 diabetes has more than doubled in recent years — though obesity and other heart risk factors have held steady, government researchers reported Monday.

The good news, the researchers say, is that teen obesity rates leveled off between 1999 and 2008 — hovering between 18 percent and 20 percent over the years.

Rates of high blood pressure and high LDL cholesterol (the “bad” kind) also remained steady.

But the picture was different with so-called pre-diabetes and with type 2 diabetes. Those conditions were seen in nine percent of teens in 1999-2000, but that figure rose to 23 percent in 2007-2008, the researchers report in the journal Pediatrics.

“That was unexpected, especially since obesity has been leveling off,” said lead researcher Ashleigh May, of the Centers for Disease Control and Prevention (CDC).

“The question of why that is will require more research,” May told Reuters Health.

Pre-diabetes refers to higher-than-normal blood sugar levels. It’s concerning, May said, because people with pre-diabetes have a heightened risk of developing type 2 diabetes, which is a major risk factor for heart disease, stroke and kidney disease.

This study did not separate pre-diabetes from type 2 diabetes, so it’s not clear how much of the rise was in full-blown diabetes, May said.

But in the past the CDC has estimated that between 2002 and 2005, the yearly rate of new type 2 diabetes diagnoses was 8.5 for every 100,000 kids ages 10 to 19.

Type 2 diabetes is closely associated with age, and middle-aged and older adults still account for most cases. In the U.S., it’s estimated that almost 26 million people have diabetes — mostly type 2. Adults age 65 and up account for about 11 million of those cases.

At one time, type 2 diabetes was almost unheard of in children. But with the rise in childhood obesity in recent decades, more kids have been diagnosed with that form of diabetes, or its potential precursor pre-diabetes.

Unhealthy blood sugar levels — or blood pressure or cholesterol levels — may not affect a teenager right away. But the concern, May noted, is that those things tend to “track” into adulthood, when they may contribute to heart attacks or stroke.

“It’s promising that we didn’t see a rise in obesity or hypertension or (high LDL),” May said. “But we still have a lot of work to do.”

The results are based on a national sample of almost 3,400 teenagers who had physical exams and blood tests between 1999 and 2008.

Rates of obesity remained stable over the years, landing at 20 percent by 2008. Another 15 percent of kids were overweight.

By 2008, 10 percent of teens had “pre-hypertension” — which means their blood pressure numbers were higher-than-normal, but not high enough to meet the definition of hypertension. Another three percent had full-blown high blood pressure.

When it came to LDL cholesterol, six percent of teens had high levels and 13 percent were borderline-high in 2008.

Those figures were similar to the ones almost a decade earlier. Pre-diabetes/diabetes was the exception.

There are limitations to the study, May’s team acknowledges. One is that they gauged pre-diabetes and diabetes from a single blood sugar measurement — which may be less reliable in kids than in adults.

Still, May said the “big message” here is that children and teenagers need more help with following a healthy diet and staying physically active.

That’s the general way of managing pre-diabetes, May said, and it’s also the key to overall health, for both heavy and normal-weight kids.

In this study, pre-diabetes/diabetes and other heart risk factors were more common in overweight or obese teens. But their normal-weight peers were far from immune.

Of those thinner kids, 37 percent had at least one heart risk factor, May pointed out.

“All kids can benefit from a healthy lifestyle,” May said.

For parents, she said, that means “modeling” healthy eating and exercise for their kids, and making sure the kitchen is stocked with foods like fruits, vegetables, whole grains and low-fat dairy — rather than junk food.

May also said that pediatricians should be following guidelines on obesity screening.

The U.S. Preventive Services Task Force, a government-backed panel, recommends that children age six and older be screened for obesity. If a child is heavy, pediatricians should offer families behavioral counseling, or refer them to someone who can.

The American Academy of Pediatrics (AAP) recommends that children have their blood pressure checked regularly starting around age four. The AAP also suggests that kids’ cholesterol be checked between the ages of nine and 11, and then again between the ages of 17 and 21.

SOURCE: Pediatrics, online May 21, 2012.

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Mon May 21, 2012 12:04pm EDT

(Reuters) – Peregrine Pharmaceuticals Inc said results from a mid-stage trial showed that its key experimental drug performed better than standard chemotherapy in lung cancer patients who had not responded to primary therapy, sending its shares up 36 percent.

Peregrine tested two doses of its drug, bavituximab, along with standard chemotherapy treatment as a second-line treatment in 112 non small-cell lung cancer patients.

These results come two months after data from another study showed that bavituximab did not fare significantly better than a placebo when used as a first-line treatment for non small-cell lung cancer.

Peregrine’s shares, which have fallen 35 percent since the first-line trial data was announced in March, were up 18 percent at $0.51 on Monday.

In the second-line treatment study, both doses met the secondary goal of stopping cancer progression for more than 4 months, compared with 3 months for those treated with a combination of the standard therapy and a placebo, Peregrine said in a statement.

“We are impressed by the strong clinical data for the primary overall response rates endpoint as well as the current indications of a survival benefit,” Roth Capital analyst Joseph Pantginis said in a note.

Peregrine is also testing bavituximab as a treatment for pancreatic cancer. However, the company is targeting a much bigger market with non small-cell lung cancer.

Non small-cell is the most common type of lung cancer. The American Cancer Society estimates lung cancer claims the lives of more than 160,000 people every year, representing about 28 percent of all cancer deaths.

The analyst said the positive results could potentially move partnering discussions to the next level and expects Peregrine to discuss the study details with U.S. health regulators in the second half of the year.

Pantginis, who had cut his price target on the stock twice since the frontline study, raised it to $5 from $3.30 and said bavituximab has a broad therapeutic potential.

The drug did not show any significant safety issues when compared with the standard therapy in the study, Peregrine said.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon)

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