By John Whitesides and Thomas Ferraro

WASHINGTON |
Thu Feb 9, 2012 8:00pm EST

WASHINGTON (Reuters) – Vice President Joe Biden said on Thursday the White House was working to address concerns raised by the Catholic Church over a new rule on contraceptives, and he believed an escalating election-year battle over the issue would be resolved.

The rule, announced on January 20, requires religious-oriented groups such as charities, hospitals and universities, but not churches, to provide coverage for birth control as other health insurance providers must do. The Catholic Church opposes most methods of birth control.

Top Republicans, including the party’s presidential candidates, have condemned the rule as an assault on religious liberty. Prominent Democrats and women’s health groups have urged President Barack Obama to hold his ground.

“I’m determined to see that this gets worked out and I believe we can work it out,” Biden, who is Catholic, told Cincinnati’s WLM radio station during a visit to Ohio.

ABC News, citing sources, said the rule had been the focus of an intense internal skirmish at the White House, with Biden, Defense Secretary Leon Panetta and then-Chief of Staff Bill Daley warning it would spark heavy political fallout.

But they lost the fight to a group that included Health and Human Services Secretary Kathleen Sebelius and senior advisers Valerie Jarrett and David Plouffe, who argued birth control saved women’s lives, reduced unwanted pregnancies and was a fundamental women’s health issue, ABC said.

The White House says the rule aimed to strike a balance between Catholic Church doctrine and women’s right to health care. But it created a political firestorm on a hot-button social issue during an election year dominated until now by debates over the faltering economy.

“The Obama administration has crossed a dangerous line, and we will fight this attack on the fundamental right of religious freedom until the courts overturn it or we’ve got a president who will reverse it,” Senate Republican Leader Mitch McConnell told a conference of conservatives in Washington.

Senate Republicans tried to offer an amendment to rescind it on Thursday but were blocked procedurally by Senate Majority Leader Harry Reid, who urged everyone to “calm down.”

Some moderate Democrats facing election this year in battleground states – like Joe Manchin in West Virginia, Robert Casey in Pennsylvania and Tim Kaine, who is seeking a Senate seat in Virginia – have opposed the rule.

Manchin and Senator Marco Rubio, a Republican from Florida, introduced a bill to block the rule, although it has little chance of success in the Democratic-controlled Senate. Most Democrats have backed Obama.

A group of about a dozen House Democrats held a news conference to urge him to stand fast on the issue. “My colleagues and I stand in solidarity with American women who have waited decades for equity in contraceptive coverage,” U.S. Representative Nita Lowey told reporters.

Polls indicate a majority of Americans and Catholics support the rule. A Public Religion Research Institute poll taken last week found 55 percent of Americans want employers to provide health-care plans that cover contraception and birth control, including nearly six in 10 Catholics.

“A HEALTH CALCULATION”

“This was not a political calculation, it was a health calculation,” a senior Obama campaign official said.

Twenty-eight states include similar requirements to Obama’s rule in their insurance regulations. Lowey said 335,000 houses of worship would be exempted.

The National Organization of Women said the rule would affect birth control access for an estimated 3 million women.

“We’re really dismayed that the U.S. Conference of Catholic Bishops is trying to impose their beliefs about what women should do with their bodies on their employees,” said Cindy Pearson, executive director of the National Women’s Health Network.

“We think every single person in the U.S. should have access to health insurance and that it should cover everything, no matter where you work,” she said.

The regulation, part of the 2010 healthcare law, requires health insurance plans to cover basic preventative care for women. The Obama administration, acting on recommendations from experts at the advisory U.S. Institute of Medicine, included birth control as part of that but exempted houses of worship.

Most employers and health plans have until August 1 to implement the new rule, but religious affiliated groups have until next year.

Many Catholic leaders have been outspoken in opposition to the rule. The Catholic Church rejects most forms of contraception such as birth control pills, but does condone the “natural” or “rhythm” method.

Archbishop of New York Timothy Dolan, president of the U.S. Conference of Catholic Bishops, called on Obama to back off from the rule and said it contradicted assurances Obama gave him during a White House meeting in November.

Dolan, designated by Pope Benedict for elevation to cardinal, said he now questions if he can work with Obama to settle concerns about the rule.

He called on Obama to “simply give a much more dramatically wide latitude to that religious exemption and protection of conscience and religious freedom, and you’re not going to hear from us any more,” Dolan said on CBS’s “This Morning” program.

“We can’t have a government bureaucracy invading the privacy and the independence and autonomy and integrity that our constitution gives to religion,” Dolan said.

The EWTN Global Catholic Network said it filed a lawsuit in the U.S. District Court in Birmingham, Alabama, seeking to block government agencies from implementing the rule. The case asks the court to find the rule unconstitutional, it said.

EWTN Global Catholic Network calls itself the largest religious media network in the world, with satellite television, radio, and print news services, and other activities.

(Additional reporting by Caren Bohan, Victoria Allen, Lily Kuo, Donna Smith, Julie Steenhuysen, Susan Heavey, Jeff Mason; Editing by Marilyn W. Thompson and Philip Barbara)

Related posts:

1. Senior U.S. Catholic cites Obama "promises" on birth control
2. Boehner vows to stop Obama contraceptive rule
3. U.S. gives church groups a year on birth control rule

Thu Feb 9, 2012 7:12pm EST

(Reuters) – The biggest professional football players in America may be more likely than their fellow players to die of heart disease, even though they appear to generally enjoy a longer-than-average lifespan, according to a U.S. study.

The report in the American Journal of Cardiology followed more than 3,400 National Football League (NFL) players who were active between 1959 and 1988, and found that 334 had died by 2007 — only about half the rate that would be expected based on U.S. norms.

But certain players, the ones who were biggest during their careers, had higher risks of dying from heart disease or stroke, with defensive linemen especially vulnerable.

The findings build on evidence that football players’ big bodies can become a health liability in the long run, said Sherry Baron, a researcher at the National Institute for Occupational Safety and Health in Cincinnati, who led the study.

“I think this makes it clear that if you’re big and muscular at a young age, it could have a long-term (health) effect,” she said.

According to the study, defensive linemen had a 42 percent higher risk of death from cardiovascular disease compared with U.S. men in general. Of 498 defensive linemen, 41 died of cardiovascular causes.

Often, professional athletes’ muscle mass can make for a high body mass index (BMI), a commonly used measure of weight in relation to height, and Baron said there was an argument that a high BMI based on muscle is not so bad.

The problem, though, is that once big athletes are no longer in the game, it’s very hard to keep up their former physical activity levels, she added. Sometimes, injury can make it impossible.

The study also showed that players with a BMI of 30 or higher during their careers, which would qualify them as “obese,” were twice as likely to die of cardiovascular causes as their lighter peers.

As for why the ex-players had a lower overall mortality rate than the general public, the authors said one factor was likely to be that few of them smoke, which has been shown in previous studies.

The high BMI numbers might not reflect the fact that more of their weight is based on muscle mass, and their overall higher fitness level and body composition may help as well, they wrote.

But other studies have found that after retirement, pro football players tend to have more heart risk factors, such as high blood pressure, unhealthy cholesterol levels and obesity, than the general public.

Cardiologists said the current study has some limitations.

One is that it relied on information from death certificates, which do not always give the whole picture, said Martin Goldman, a cardiologist at Mt Sinai Medical Center in New York, who has studied heart risks for NFL players.

There are also many unknowns, such as how the players’ BMIs changed over time, or what kind of lifestyle they led after retirement.

Still, he agreed that the bottom line does seem to be that size matters, adding that big players need to make an effort to lose weight once they’re no longer playing.

“They don’t necessarily change their eating habits, even though they’re not exercising as much,” he said.

Both Baron and Goldman agreed that there are implications beyond the NFL, since college and high school football players tend to bulk up to play. And there is evidence this may put them at risk for heart disease later on.

“Young athletes may strive to look like the professional players, but they need to realize there could be long-term health effects,” Baron added. SOURCE: bit.ly/xPPpyF

(Reporting from New York by Amy Norton at Reuters Health; editing by Elaine Lies and Bob Tourtellotte)

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2. Arteries still healthy in young football players
3. Ankle braces may help teen football players

By Andrew M. Seaman

NEW YORK |
Thu Feb 9, 2012 6:38pm EST

NEW YORK (Reuters Health) – People enrolled in early stage trials for possible cancer treatments may underestimate the risks involved and overestimate the potential benefits, suggests a new study.

The early trials, known as “Phase 1,” are often the first time a new drug is given to humans and the goal of the studies is to test for side effects and acceptable dosage levels. Participation rarely benefits the person’s health.

One of the new report’s authors says it’s well known that people taking part in early trials confuse the research for medical care, but it goes beyond that.

“What we found was that the picture of understanding is much more complicated than once thought,” said Rebecca Pentz, a research ethics professor at Emory University’s School of Medicine in Atlanta who led the study.

Pentz told Reuters Health in an email that when participants describe the risks and benefits of participating in the trial, they may use their descriptions to stay hopeful. She added that they also may not understand that participating in research comes with its own risks, including extra biopsies.

For their study, the researchers interviewed and surveyed 95 patients in a Phase 1 cancer trial.

To find out if they were confusing the research for medical care, the researchers asked whether the trial was meant to help research or them as a person, and whether the study or their own physician decides what the treatments will be.

Only 31 people correctly said that the aim of the study was to benefit research and that the study decided the treatment.

Some believe the misconception may stem from early trial participants — who may have tried medications that failed, or have a rare illness for which the study drug is targeted — having few treatment options, but the researchers did not find this to be the case.

As to whether participants overestimated the trial’s benefits or underestimated its risks, the researchers found that 59 people said they had a 70 percent or better chance of having some sort of personal benefit. That same number of people estimated their risk to be 30 percent or less.

The researchers said 89 people misestimated the risks and benefits.

A popular theory is that a person’s optimism may cloud their judgment when evaluating what risks are involved.

While 89 people ranked their optimism level as “high,” and the authors say that may support the claim, Pentz says she was surprised to find 29 people estimated their personal benefit to be lower or their personal risk to be higher than the rest of the group. They were pessimists.

“We know that many research trial participants are optimistic that they will do better than most people on trial. But we found a significant minority who expected to do worse but still participated in the trial. We don’t have an explanation for this,” Pentz told Reuters Health.

Overall, the authors write in the journal Cancer, their results show participants still confuse the research for treatment and don’t understand how the two differ, despite advancements made in the last decade.

Mary Faith Marshall, a professor of bioethics at the University of Minnesota in Minneapolis, said despite the study’s limitations — which include being from a single center and surveying a predominately white and affluent group — the results are consistent with past research.

“We’ve known for a long time that this problem exists and that there are ways to improve the informed consent process that would get at some of these problems,” said Marshall, who was not involved with the new study.

Marshall said researchers can make sure participants know the trial’s intent and risks by quizzing them and avoiding language that would suggest that there are benefits.

For example, Marshall said sometimes the forms people fill out before a trial use the word “patient,” instead of something like “research participant.”

“When you see the word patient you’re going to think ‘therapeutic.’ Why wouldn’t you?” Marshall told Reuters Health.

Christine Grady, acting chief of the Department of Bioethics at the National Institutes of Health Clinical Center said federally funded research and research that will eventually be vetted by the U.S. Food and Drug Administration must meet certain requirements regarding consent.

“The regulations are not specific to Phase 1 studies. They’re generic,” Grady told Reuters Health.

She added that regulations include such things as the fact that the trial is voluntary, what the expectations are, the risks and benefits and who to contact for more information.

In fact, the National Cancer Institute, which provided funding for Pentz’s study, has a consent form template available on the agency’s website.

But Marshall said it’s understandable that people can be confused, especially if they’re suffering from cancer or in other stressful situations.

“If you have a diagnosis of cancer it’s a hugely stressful time. Even when investigators and their staff do the best job, we forget things,” said Marshall.

SOURCE: bit.ly/zBXLvn Cancer, online January 31, 2012.

Related posts:

1. Cancer trial participants may have misconceptions
2. Infinity stops cancer trial as drug fails to show
3. FDA puts Immunomedics cancer drug trial on hold

By Andrew M. Seaman

NEW YORK |
Thu Feb 9, 2012 6:38pm EST

NEW YORK (Reuters Health) – People enrolled in early stage trials for possible cancer treatments may underestimate the risks involved and overestimate the potential benefits, suggests a new study.

The early trials, known as “Phase 1,” are often the first time a new drug is given to humans and the goal of the studies is to test for side effects and acceptable dosage levels. Participation rarely benefits the person’s health.

One of the new report’s authors says it’s well known that people taking part in early trials confuse the research for medical care, but it goes beyond that.

“What we found was that the picture of understanding is much more complicated than once thought,” said Rebecca Pentz, a research ethics professor at Emory University’s School of Medicine in Atlanta who led the study.

Pentz told Reuters Health in an email that when participants describe the risks and benefits of participating in the trial, they may use their descriptions to stay hopeful. She added that they also may not understand that participating in research comes with its own risks, including extra biopsies.

For their study, the researchers interviewed and surveyed 95 patients in a Phase 1 cancer trial.

To find out if they were confusing the research for medical care, the researchers asked whether the trial was meant to help research or them as a person, and whether the study or their own physician decides what the treatments will be.

Only 31 people correctly said that the aim of the study was to benefit research and that the study decided the treatment.

Some believe the misconception may stem from early trial participants — who may have tried medications that failed, or have a rare illness for which the study drug is targeted — having few treatment options, but the researchers did not find this to be the case.

As to whether participants overestimated the trial’s benefits or underestimated its risks, the researchers found that 59 people said they had a 70 percent or better chance of having some sort of personal benefit. That same number of people estimated their risk to be 30 percent or less.

The researchers said 89 people misestimated the risks and benefits.

A popular theory is that a person’s optimism may cloud their judgment when evaluating what risks are involved.

While 89 people ranked their optimism level as “high,” and the authors say that may support the claim, Pentz says she was surprised to find 29 people estimated their personal benefit to be lower or their personal risk to be higher than the rest of the group. They were pessimists.

“We know that many research trial participants are optimistic that they will do better than most people on trial. But we found a significant minority who expected to do worse but still participated in the trial. We don’t have an explanation for this,” Pentz told Reuters Health.

Overall, the authors write in the journal Cancer, their results show participants still confuse the research for treatment and don’t understand how the two differ, despite advancements made in the last decade.

Mary Faith Marshall, a professor of bioethics at the University of Minnesota in Minneapolis, said despite the study’s limitations — which include being from a single center and surveying a predominately white and affluent group — the results are consistent with past research.

“We’ve known for a long time that this problem exists and that there are ways to improve the informed consent process that would get at some of these problems,” said Marshall, who was not involved with the new study.

Marshall said researchers can make sure participants know the trial’s intent and risks by quizzing them and avoiding language that would suggest that there are benefits.

For example, Marshall said sometimes the forms people fill out before a trial use the word “patient,” instead of something like “research participant.”

“When you see the word patient you’re going to think ‘therapeutic.’ Why wouldn’t you?” Marshall told Reuters Health.

Christine Grady, acting chief of the Department of Bioethics at the National Institutes of Health Clinical Center said federally funded research and research that will eventually be vetted by the U.S. Food and Drug Administration must meet certain requirements regarding consent.

“The regulations are not specific to Phase 1 studies. They’re generic,” Grady told Reuters Health.

She added that regulations include such things as the fact that the trial is voluntary, what the expectations are, the risks and benefits and who to contact for more information.

In fact, the National Cancer Institute, which provided funding for Pentz’s study, has a consent form template available on the agency’s website.

But Marshall said it’s understandable that people can be confused, especially if they’re suffering from cancer or in other stressful situations.

“If you have a diagnosis of cancer it’s a hugely stressful time. Even when investigators and their staff do the best job, we forget things,” said Marshall.

SOURCE: bit.ly/zBXLvn Cancer, online January 31, 2012.

Related posts:

1. Cancer trial participants may have misconceptions
2. Infinity stops cancer trial as drug fails to show
3. FDA puts Immunomedics cancer drug trial on hold

By Genevra Pittman

NEW YORK |
Thu Feb 9, 2012 6:37pm EST

NEW YORK (Reuters Health) – In a new study, states with more comprehensive sex education programs had lower teen birth rates — but the effect seemed to be due more to political, religious and social differences between those states than the sex ed itself.

That doesn’t mean sex ed never helps prevent pregnancy, researchers said. But attitudes of family and friends, and whether teens have access to contraception and family planning services, might be just as important to putting a dent in the number of new teen moms.

“Although the teen birth rates and teen pregnancy rates are dropping year after year… we still have disparities between states, and we have higher teen birth and teen pregnancy rates when we’re compared to other industrialized countries,” said Patricia Cavazos-Rehg, from Washington University in St. Louis, who worked on the study.

Researchers said there have been mixed results when it comes to whether a comprehensive sex ed program, which teaches contraceptive use and HIV prevention, does prevent teen births.

Whether school programs should include anything other than abstinence-only education has also been the topic of political battles in some parts of the country.

To get a big-picture take on sex ed’s effectiveness, Cavazos-Rehg and her colleagues compared curriculums in 24 states with birth rates for girls ages 15 to 17 in those states between 1997 and 2005.

They found wide variation over the study period, from one birth in every 100 New Hampshire girls each year to three or four births for every 100 Arkansas girls.

In general, the more districts in a state that covered how to use a condom, how to prevent HIV and other sex ed topics, the fewer teen births there were, the researchers report in the Archives of Pediatrics & Adolescent Medicine.

But when they took into account race, poverty and crime levels in states, much of the link disappeared: poorer states with more minorities and more crime had less sex ed and more teen births. And when “religiosity” and laws on abortion were thrown into the mix, sex ed programs themselves no longer predicted birth rates.

Researchers said that there are a number of ways to interpret the findings — but none of them suggest teens can’t learn from sex ed.

First, conservative and religious states might teach sex ed in a less effective way than liberal ones — meaning more teens in those states end up pregnant.

“There can be enormous variation between what goes on in one state and what goes on in another state even if they both indicate that they discuss how to use a condom or pregnancy prevention,” said Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia.

Or, it could be that teen pregnancy rates are more similar between states, but in places with liberal abortion laws, more adolescent girls end their pregnancies early.

Cavazos-Rehg said that abortions may account for some of the difference in birth rates, but not all of it. Although data on pregnancy rates are less comprehensive, she said, her own research has still shown much higher teen pregnancy rates in Arkansas and Mississippi, for example, than in New England.

Regardless of what teens are taught in school, whether they can easily get condoms and have their parents’ support for “healthy sexual decision-making” may depend on state politics and social factors, Marla Eisenberg, an adolescent health and medicine researcher at the University of Minnesota in Minneapolis, told Reuters Health in an email.

“In short, school-based sex ed is only one part of a much larger puzzle of influences on adolescent sexual behavior, and as the authors conclude, the demographic, religious and political environment matters a lot,” added Eisenberg, who didn’t participate in the new research.

Still, sex ed can be improved, the experts agreed.

To prevent teen pregnancies, kids in sex ed need to be taught more than just how to use a condom, but the consequences of getting pregnant and having a baby, according to Cavazos-Rehg.

Bleakley, who also wasn’t involved in the new study, called for better standards regarding what goes into a comprehensive sex ed program, and better training of instructors across states, to erase any disparities that could be tied to the religious and political environment in a given area.

SOURCE: bit.ly/AquJBE Archives of Pediatrics & Adolescent Medicine, online February 6, 2012.

Related posts:

1. Does sex ed keep girls from becoming teen moms?
2. U.S. teen birth rate drops to record low in 2010
3. Teen pregnancy, abortion rates at record low, study says

By Genevra Pittman

NEW YORK |
Thu Feb 9, 2012 6:37pm EST

NEW YORK (Reuters Health) – In a new study, states with more comprehensive sex education programs had lower teen birth rates — but the effect seemed to be due more to political, religious and social differences between those states than the sex ed itself.

That doesn’t mean sex ed never helps prevent pregnancy, researchers said. But attitudes of family and friends, and whether teens have access to contraception and family planning services, might be just as important to putting a dent in the number of new teen moms.

“Although the teen birth rates and teen pregnancy rates are dropping year after year… we still have disparities between states, and we have higher teen birth and teen pregnancy rates when we’re compared to other industrialized countries,” said Patricia Cavazos-Rehg, from Washington University in St. Louis, who worked on the study.

Researchers said there have been mixed results when it comes to whether a comprehensive sex ed program, which teaches contraceptive use and HIV prevention, does prevent teen births.

Whether school programs should include anything other than abstinence-only education has also been the topic of political battles in some parts of the country.

To get a big-picture take on sex ed’s effectiveness, Cavazos-Rehg and her colleagues compared curriculums in 24 states with birth rates for girls ages 15 to 17 in those states between 1997 and 2005.

They found wide variation over the study period, from one birth in every 100 New Hampshire girls each year to three or four births for every 100 Arkansas girls.

In general, the more districts in a state that covered how to use a condom, how to prevent HIV and other sex ed topics, the fewer teen births there were, the researchers report in the Archives of Pediatrics & Adolescent Medicine.

But when they took into account race, poverty and crime levels in states, much of the link disappeared: poorer states with more minorities and more crime had less sex ed and more teen births. And when “religiosity” and laws on abortion were thrown into the mix, sex ed programs themselves no longer predicted birth rates.

Researchers said that there are a number of ways to interpret the findings — but none of them suggest teens can’t learn from sex ed.

First, conservative and religious states might teach sex ed in a less effective way than liberal ones — meaning more teens in those states end up pregnant.

“There can be enormous variation between what goes on in one state and what goes on in another state even if they both indicate that they discuss how to use a condom or pregnancy prevention,” said Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia.

Or, it could be that teen pregnancy rates are more similar between states, but in places with liberal abortion laws, more adolescent girls end their pregnancies early.

Cavazos-Rehg said that abortions may account for some of the difference in birth rates, but not all of it. Although data on pregnancy rates are less comprehensive, she said, her own research has still shown much higher teen pregnancy rates in Arkansas and Mississippi, for example, than in New England.

Regardless of what teens are taught in school, whether they can easily get condoms and have their parents’ support for “healthy sexual decision-making” may depend on state politics and social factors, Marla Eisenberg, an adolescent health and medicine researcher at the University of Minnesota in Minneapolis, told Reuters Health in an email.

“In short, school-based sex ed is only one part of a much larger puzzle of influences on adolescent sexual behavior, and as the authors conclude, the demographic, religious and political environment matters a lot,” added Eisenberg, who didn’t participate in the new research.

Still, sex ed can be improved, the experts agreed.

To prevent teen pregnancies, kids in sex ed need to be taught more than just how to use a condom, but the consequences of getting pregnant and having a baby, according to Cavazos-Rehg.

Bleakley, who also wasn’t involved in the new study, called for better standards regarding what goes into a comprehensive sex ed program, and better training of instructors across states, to erase any disparities that could be tied to the religious and political environment in a given area.

SOURCE: bit.ly/AquJBE Archives of Pediatrics & Adolescent Medicine, online February 6, 2012.

Related posts:

1. Does sex ed keep girls from becoming teen moms?
2. U.S. teen birth rate drops to record low in 2010
3. Teen pregnancy, abortion rates at record low, study says

By Kerry Grens

NEW YORK |
Thu Feb 9, 2012 6:36pm EST

NEW YORK (Reuters Health) – About two-thirds of women diagnosed with early stage breast cancer want to take part in making decisions about their treatment, according to a new survey of patients from five different countries.

Some of these women want complete control over making treatment choices while others want to share the decision with their doctor — yet only a minority of them actually get the level of involvement they are hoping for.

“Physicians should be trying to elicit patient preferences,” said Richard Brown, the lead author of the study and an assistant professor at Virginia Commonwealth University.

Brown’s team asked 683 women who were recently diagnosed with breast cancer what kind of role they would like to have in making decisions about their treatment: would they like to have total control, a shared role with their doctor, or have the doctor make the choices.

After the women met with their physicians, the researchers followed up to ask how their visit went and whether their preferences for how involved they would like to be in the future had changed.

Only 28 out of every 100 women initially wanted to delegate the decision to their doctor, but 46 out of every 100 reported that their doctor ended up making the decision.

“I think it’s not so surprising that the actual decision making tended to be more doctor-directed than the patients wanted,” said Dr. Michael Barry, president of the Foundation for Informed Medical Decision Making, who was not involved in this study.

“I think sometimes clinicians think most patients don’t want to participate in decisions, particularly around serious things like cancer, and that’s not the finding here or in previous studies,” he told Reuters Health.

Among the 282 women who changed their preference after the consultation with their doctor, a little more than half of them shifted toward a greater involvement.

A third of them originally wanted their doctor to make the decision and later preferred to either share it or take control themselves, and one in five who originally wanted to share the decision later preferred to make the choice on their own.

When women had more involvement than they originally intended, they “were less conflicted over the decision, more satisfied with their ultimate decision, more satisfied with the consultation communication” than women who had less involvement, the authors write in the Journal of Clinical Oncology.

Barry said the findings make sense for women with early-stage breast cancer, because there are often multiple, effective options for treatment.

For instance, the risk of death might be the same if a woman has her breast removed compared to having her breast preserved, but one woman might prioritize keeping her breast and be more willing to go through the extra surgeries and radiation.

“When patients then understand there are multiple reasonable options for treatment of early stage breast cancer…usually you’ll see more desire for participatory decision making,” Barry said.

After they had the consultation with their doctor, about a third of the women in the study continued to want their physicians to have control over the decision.

“The preference to leave the decision to the physician is a perfectly reasonable decision to make,” Brown told Reuters Health.

He and his colleagues note in the new report that they intend to pursue future studies of patients with other cancers, especially those with limited treatment options.

SOURCE: bit.ly/xp9uLX Journal of Clinical Oncology, online February 6, 2012.

Related posts:

1. Most women with cancer want a role in decisions
2. Sexual problems common in women with breast cancer
3. Women with high breast cancer risk refuse MRIs

By Kerry Grens

NEW YORK |
Thu Feb 9, 2012 6:36pm EST

NEW YORK (Reuters Health) – About two-thirds of women diagnosed with early stage breast cancer want to take part in making decisions about their treatment, according to a new survey of patients from five different countries.

Some of these women want complete control over making treatment choices while others want to share the decision with their doctor — yet only a minority of them actually get the level of involvement they are hoping for.

“Physicians should be trying to elicit patient preferences,” said Richard Brown, the lead author of the study and an assistant professor at Virginia Commonwealth University.

Brown’s team asked 683 women who were recently diagnosed with breast cancer what kind of role they would like to have in making decisions about their treatment: would they like to have total control, a shared role with their doctor, or have the doctor make the choices.

After the women met with their physicians, the researchers followed up to ask how their visit went and whether their preferences for how involved they would like to be in the future had changed.

Only 28 out of every 100 women initially wanted to delegate the decision to their doctor, but 46 out of every 100 reported that their doctor ended up making the decision.

“I think it’s not so surprising that the actual decision making tended to be more doctor-directed than the patients wanted,” said Dr. Michael Barry, president of the Foundation for Informed Medical Decision Making, who was not involved in this study.

“I think sometimes clinicians think most patients don’t want to participate in decisions, particularly around serious things like cancer, and that’s not the finding here or in previous studies,” he told Reuters Health.

Among the 282 women who changed their preference after the consultation with their doctor, a little more than half of them shifted toward a greater involvement.

A third of them originally wanted their doctor to make the decision and later preferred to either share it or take control themselves, and one in five who originally wanted to share the decision later preferred to make the choice on their own.

When women had more involvement than they originally intended, they “were less conflicted over the decision, more satisfied with their ultimate decision, more satisfied with the consultation communication” than women who had less involvement, the authors write in the Journal of Clinical Oncology.

Barry said the findings make sense for women with early-stage breast cancer, because there are often multiple, effective options for treatment.

For instance, the risk of death might be the same if a woman has her breast removed compared to having her breast preserved, but one woman might prioritize keeping her breast and be more willing to go through the extra surgeries and radiation.

“When patients then understand there are multiple reasonable options for treatment of early stage breast cancer…usually you’ll see more desire for participatory decision making,” Barry said.

After they had the consultation with their doctor, about a third of the women in the study continued to want their physicians to have control over the decision.

“The preference to leave the decision to the physician is a perfectly reasonable decision to make,” Brown told Reuters Health.

He and his colleagues note in the new report that they intend to pursue future studies of patients with other cancers, especially those with limited treatment options.

SOURCE: bit.ly/xp9uLX Journal of Clinical Oncology, online February 6, 2012.

Related posts:

1. Most women with cancer want a role in decisions
2. Sexual problems common in women with breast cancer
3. Women with high breast cancer risk refuse MRIs

By Deena Beasley

Thu Feb 9, 2012 3:58pm EST

(Reuters) – The U.S. Food and Drug Administration’s long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans.

The proposed rules, issued on Thursday, require studies showing that the generic copies are “highly similar” to the originals, but there are several ways that might be proven.

Because of their complexity, generic copies of biotech drugs — first introduced in the 1980s — are known as “biosimilars.”

“We’re trying to send the signal that it’s not one size fits all. It’s product by product,” said Rachel Sherman, director of the FDA’s office of medical policy during a conference call with reporters.

The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as more than 30 branded biologics with sales of $51 billion lose patent exclusivity, according to market analysis firm Datamonitor.

The FDA rules would set “an abbreviated pathway” to approval that would consider factors including a product’s complexity, formulation, and stability, the agency said.

The proposal “reads largely as we expected, although a few points read as slightly more friendly to the generics industry,” ISI Group analyst Mark Schoenebaum said in a note to clients.

The FDA said it would decide on the “extent and scope of animal and clinical studies” needed for approval once it has considered other analytical data.

Manufacturers will have the option of asking the FDA to deem their copies “interchangable” with a brand-name drug, but the agency said that would require additional clinical studies.

Makers of branded biotech drugs have argued that full-scale human trials need to be conducted before a rival version of an existing biologic drug should be allowed on the market.

Despite such qualms, biotech drug makers including Amgen Inc, Merck & Co and Biogen Idec are working to produce rival versions of biotech drugs made by competitors.

The Congressional Budget Office has estimated that the United States could save $25 billion from the use of biosimilars over 10 years.

European regulators have already approved cheaper versions of some biotech drugs.

The FDA said advances in science and manufacturing may facilitate fingerprint-like analysis of therapeutic protein products, which may allow for a more selective approach to any animal or human studies.

Unlike conventional, easy-to-replicate, chemical-based drug compounds, biotech drugs are derived from living organisms, such as proteins, and are often produced using recombinant DNA technologies.

Once a traditional pill loses patent protection, there is a quick regulatory pathway for generic drugmakers to sell much cheaper versions of the branded medicine. Similar U.S. guidelines for biotech drugs have been under negotiation for several years.

Biosimilar drugs are expected to sell at discounts of 25 percent to 45 percent to branded rivals, compared with generic versions of traditional pills that often sell for one-tenth the price of the branded product.

Under the U.S. healthcare reform law passed in 2010, brand-name biotech drugs — ranging from relatively simple molecules like insulin to complex antibodies used to treat cancer — were granted a 12-year period of market exclusivity, after which generic versions can be sold.

Opposing trade groups — the Biotechnology Industry Organization and the Generic Pharmaceutical Association — said they are reviewing the proposed rules.

The generic drugs group said it was pleased with the FDA’s action, which it called “an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients.”

The FDA said it is accepting public comment on the draft guidance documents for the next 60 days.

(Additional reporting by Bill Berkrot and Ana Yukhananov; Reporting By Deena Beasley; Editing by Gerald E. McCormick and John Wallace)

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By Kerry Grens

NEW YORK |
Thu Feb 9, 2012 4:25pm EST

NEW YORK (Reuters Health) – A low-key, long term approach to teen weight loss produced modest benefits in a clinical trial, Australian researchers report, though a version of the program that added texts and emails didn’t help kids slim down any further.

The study, by Binh Nguyen at the University of Sydney and colleagues, included 151 teenagers in a 24-month program called Loozit, based on group behavior-modification sessions for teens and their parents.

At the 12-month mark, 40 percent of the teens had reduced their body mass by at least five percent and a quarter had reduced by at least 10 percent, though most remained overweight.

Despite the small effect on weight, Elissa Jelalian of Brown University in Providence, Rhode Island, said the results are promising because the program was less intensive than other weight loss efforts, and yet had nearly the same impact.

“I think it’s certainly worthy of further investigation,” Jelalian, who was not involved in the new work, told Reuters Health.

During the first two months of Loozit, the kids, who were between 13 and 16 years old, participated in seven weekly group sessions that focused on healthy eating habits, increasing physical activity, decreasing time spent in front of a screen and improving self esteem.

They also spent some time exercising and preparing and tasting foods during the sessions.

Parents, too, attended weekly group sessions where lifestyle-modification was discussed.

For the next 22 months, teens and parents went to booster sessions every three months.

The study’s results, published in the Archives of Pediatrics & Adolescent, only include outcomes from the first 12 months of the program, which 124 kids completed.

Jelalian said other weight loss programs for kids have relied on group interventions, “which I think can be helpful. They try to mobilize other kids their age who are dealing with similar challenges and to create a peer group.”

The differences between Loozit and other programs is that the kids only go through 14 sessions over two years, compared to about 20 in other cases, and the discussions are held in community locations rather than in academic or hospital settings.

Most studies of teen weight-loss approaches have centered on more intensive and heavily monitored interventions, sometimes in in-patient settings, the researchers note.

The other thing Nguyen’s group did differently is that half of the kids also received text messages, emails and phone calls to follow up and coach them through the program.

“That’s the direction a lot of people are going. And it makes sense, teens are plugged in,” said Jelalian, who was not involved in this study. “Unfortunately, it didn’t look like that added anything to their findings.”

After the 12 months there were no differences in weight loss, cholesterol levels, mental health and behavioral measures between the two groups.

“It is possible that the (additional contact) provided was too mild and that participants could have benefited from more frequent, intensive contact,” Nguyen wrote in an email to Reuters Health.

She added that the results don’t prove that coaching through texts or emails is ineffective, and future research should look at whether more frequent contact could help make a difference.

There were positive differences between where the teens started out and where they ended up, the researchers point out.

The kids had lower cholesterol and triglyceride levels at the end of the year as well as higher scores on measures of self worth, academic and athletic abilities, and social acceptance.

On average, the kids actually gained weight — which isn’t necessarily surprising, given that they grew more than an inch during the study period.

To account for this, the researchers looked at changes in the kids’ body mass index (BMI), a measure of weight relative to height.

After adjusting for a child’s age and sex, the researchers found a slight drop in BMI after 12 months, indicating that the kids were shifting toward a more normal body size, although they were still overweight.

Jelalian said it’s important to try new approaches to getting overweight and obese kids to lose weight, because research has typically focused on adults or younger children.

“There are some developmental considerations for adolescents that are unique,” she said, such as the onset of puberty and a growing independence from parents.

“There are few other programs for this age group and that are sustainable in community-based settings,” Nguyen said. “We know of no others in Australia that have been tested in research studies.”

She said she would definitely recommend Loozit for overweight teens. And that her team is following up with a study on the results of the full 24 months of the trial.

So far, “These findings highlight the potential benefits of a low intensity weight management program targeted at adolescents that is sustainable in community settings,” Nguyen and her colleagues write in their report.

SOURCE: bit.ly/yuGsmr Archives of Pediatrics & Adolescent Medicine, February 2012.

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