More U.S. women using the "morning-after" pill: report

By Susan Heavey

WASHINGTON | Thu Feb 14, 2013 12:10am EST

WASHINGTON (Reuters) - More U.S. women are taking the "morning-after" pill, but generally just once, according to the government's first report on how the emergency contraception drug has been used since regulators eased access to it in 2006.

About 11 percent of sexually active women, or 5.8 million, used the pill between 2006 and 2010, compared to about 4 percent in 2002, the Centers for Disease Control and Prevention said in its report released on Thursday.

Among those who used the pill during those four years, 59 percent said they took it just once, while 24 percent said they used it twice, the report said. Seventeen percent said they used it three times or more.

Emergency contraception has been available by prescription in the United States since 1999. One version of the morning-after pill, known as Plan B, has stirred the most political controversy.

Plan B, much like regular birth control, stops pregnancy by blocking the release of a woman's egg, or it may prevent fertilization or implantation in the uterus. But it must be taken within days after intercourse to work.

The U.S. Food and Drug Administration approved sales of Plan B to adult women without a prescription in 2006 after years of contentious debate. It later loosened the restriction to include 17-year-olds.

Women's health groups lauded the move as a way to prevent unwanted pregnancies. But conservatives warned it could lead to promiscuity, especially among youth, and more sexual assaults.

Amy Allina of the National Women's Health Network said CDC's findings show morning-after pills are not replacing conventional birth control methods for most women, although "there are some for whom it's clearly not a one-time thing."

Activists are still pressing for over-the-counter access and no age restrictions.

The pill is sold by Teva Pharmaceutical Industries Ltd as Plan B. It also is available as a generic. In 2010 the FDA approved another emergency contraceptive called ella, a prescription drug now owned by Actavis Inc.

RACE, EDUCATION

CDC's findings showed the reasons for emergency contraception use varied depending on race and education levels.

Hispanics and blacks were more likely than whites to report using the drug after unprotected sex. More white women said they used it because they were worried their other birth control method had failed, CDC said.

Those with at least some college education were more likely to use the pill than those with a high school education or less, according to the report, which is based on data from the CDC's National Survey of Family Growth.

"The women who are less likely to have access to healthcare are more likely to say 'I didn't use another method, and I turned to emergency contraception to protect myself,'" said Allina.

Some women may choose to use it occasionally if they cannot afford other methods, she added.

In a separate report on Thursday, CDC looked at overall contraceptive use and found that while the number of women using regular birth control pills has remained flat over time, the use of injections, patches and intrauterine devices has grown.

The number of women whose partners have used condoms also rose, the findings showed.

That trend may reflect increased wariness among Americans to have children amid the 2007-2009 economic recession, the effects of which are still being felt by many, according to researchers at the Guttmacher Institute, which also tracks birth control use.

"At the same time, it can make it harder for people to have access to birth control because of costs," especially for disadvantaged women who face higher rates of unintended pregnancies, said Lawrence Finer, head of domestic research for the reproductive research group.

That situation could change in the wake of the 2010 healthcare overhaul that required health insurers to begin covering birth control last year, although the law faces legal challenges.

Religious groups, particularly Catholics, charge that the provision violates their belief against artificial birth control and are fighting to block it.

(Reporting by Susan Heavey; Editing by Xavier Briand)

View the original article here

Obama Medicare rebate plan could hurt drug companies

By Bill Berkrot and David Morgan

Wed Feb 13, 2013 6:30pm EST

n">(Reuters) - President Barack Obama's decision to spotlight drug rebates as a way to save money on Medicare is likely to be opposed by the pharmaceutical industry, which could potentially lose billions of dollars in profits.

In his annual State of the Union speech on Tuesday, Obama said he would "reduce taxpayer subsidies to prescription drug companies" to rein in the rising cost of Medicare, the $600 billion healthcare program for the elderly and disabled.

Administration officials say the President was talking about requiring pharmaceutical manufacturers to offer rebates on drugs for 10 million people known as "dual eligibles" because they qualify for Medicare and Medicaid, and receive drug benefits through Medicare's Part D prescription drug program. Medicaid is the federal and state funded healthcare program for the poor.

The nonpartisan Congressional Budget Office estimates that requiring rebates for dual eligibles would save $137 billion in Medicare spending. Often the oldest and sickest beneficiaries, dual eligibles account for fewer than 20 percent of Medicare beneficiaries, but more than 30 percent of program spending.

Damien Conover, an analyst with the Morningstar investment research firm, said requiring Medicaid-level rebates for dual eligibles could trim 2 percent to 7 percent from the profits of drug manufacturers. The impact would vary depending on how much of a company's business is in the United States and how much is dependent on Medicare reimbursement, he said.

The U.S. pharmaceutical industry takes in about $300 billion a year in revenue.

"For most companies, it's probably a couple of percent hit to earnings, which is something clearly negative for the industry but manageable," said Barbara Ryan, a long-term pharmaceutical industry analyst, who now runs her own consulting firm. "Whether it could happen or not is another question, but it's unequivocally going to be the hot potato that's thrown around for the industry."

The rebate proposal, which has been circulating among policymakers and think tanks in Washington for years, had drawn industry ire before Obama's remarks on Tuesday.

Eli Lilly & Co Chief Executive John Lechleiter estimated it would cost the industry $112 billion over 10 years and reduce the number of new drugs developed.

"I think this would be disastrous for patients. It would be disastrous for pharmaceutical research. We think it's bad policy and we are going to fight it," he told a biotech conference in New York on Monday.

Other major drug companies contacted by Reuters, including Merck & Co and Pfizer Inc, declined to comment on the potential impact.

Pharmaceutical Research and Manufacturers of America, the industry's chief Washington trade group, warned that the proposal could "up-end" the successful Medicare Part D program that allows beneficiaries to purchase private drug coverage priced through competition.

It was unclear whether the proposal would ever succeed as legislation, given a bitterly divided Congress and predictions by some lobbyists that Medicare would see reforms only under a broad agreement that would require Republicans to accept higher tax revenues.

But analysts say the President, who this week backed away from a separate proposal to raise Medicare's eligibility age to 67 from 65, has few alternatives for wringing fiscal savings from the program. One option is raising costs for wealthier Americans eligible for Medicare benefits, which he also highlighted in his speech on Tuesday.

"Those two ideas are among the most palatable ideas for getting savings from the Medicare program," said Drew Altman, president and chief executive of the nonpartisan Kaiser Family Foundation, which tracks healthcare issues.

(Reporting by David Morgan in Washington and by Bill Berkrot in New York; Editing by Jilian Mincer and Leslie Gevirtz)

View the original article here

Obama Medicare rebate plan could hurt drug companies

By Bill Berkrot and David Morgan

Wed Feb 13, 2013 6:30pm EST

n">(Reuters) - President Barack Obama's decision to spotlight drug rebates as a way to save money on Medicare is likely to be opposed by the pharmaceutical industry, which could potentially lose billions of dollars in profits.

In his annual State of the Union speech on Tuesday, Obama said he would "reduce taxpayer subsidies to prescription drug companies" to rein in the rising cost of Medicare, the $600 billion healthcare program for the elderly and disabled.

Administration officials say the President was talking about requiring pharmaceutical manufacturers to offer rebates on drugs for 10 million people known as "dual eligibles" because they qualify for Medicare and Medicaid, and receive drug benefits through Medicare's Part D prescription drug program. Medicaid is the federal and state funded healthcare program for the poor.

The nonpartisan Congressional Budget Office estimates that requiring rebates for dual eligibles would save $137 billion in Medicare spending. Often the oldest and sickest beneficiaries, dual eligibles account for fewer than 20 percent of Medicare beneficiaries, but more than 30 percent of program spending.

Damien Conover, an analyst with the Morningstar investment research firm, said requiring Medicaid-level rebates for dual eligibles could trim 2 percent to 7 percent from the profits of drug manufacturers. The impact would vary depending on how much of a company's business is in the United States and how much is dependent on Medicare reimbursement, he said.

The U.S. pharmaceutical industry takes in about $300 billion a year in revenue.

"For most companies, it's probably a couple of percent hit to earnings, which is something clearly negative for the industry but manageable," said Barbara Ryan, a long-term pharmaceutical industry analyst, who now runs her own consulting firm. "Whether it could happen or not is another question, but it's unequivocally going to be the hot potato that's thrown around for the industry."

The rebate proposal, which has been circulating among policymakers and think tanks in Washington for years, had drawn industry ire before Obama's remarks on Tuesday.

Eli Lilly & Co Chief Executive John Lechleiter estimated it would cost the industry $112 billion over 10 years and reduce the number of new drugs developed.

"I think this would be disastrous for patients. It would be disastrous for pharmaceutical research. We think it's bad policy and we are going to fight it," he told a biotech conference in New York on Monday.

Other major drug companies contacted by Reuters, including Merck & Co and Pfizer Inc, declined to comment on the potential impact.

Pharmaceutical Research and Manufacturers of America, the industry's chief Washington trade group, warned that the proposal could "up-end" the successful Medicare Part D program that allows beneficiaries to purchase private drug coverage priced through competition.

It was unclear whether the proposal would ever succeed as legislation, given a bitterly divided Congress and predictions by some lobbyists that Medicare would see reforms only under a broad agreement that would require Republicans to accept higher tax revenues.

But analysts say the President, who this week backed away from a separate proposal to raise Medicare's eligibility age to 67 from 65, has few alternatives for wringing fiscal savings from the program. One option is raising costs for wealthier Americans eligible for Medicare benefits, which he also highlighted in his speech on Tuesday.

"Those two ideas are among the most palatable ideas for getting savings from the Medicare program," said Drew Altman, president and chief executive of the nonpartisan Kaiser Family Foundation, which tracks healthcare issues.

(Reporting by David Morgan in Washington and by Bill Berkrot in New York; Editing by Jilian Mincer and Leslie Gevirtz)

View the original article here

Evidence lacking on how to help kids after trauma

By Genevra Pittman

NEW YORK | Wed Feb 13, 2013 4:58pm EST

NEW YORK (Reuters Health) - There's no good evidence to say what types of treatment might help ward off anxiety and stress disorders in kids and teens exposed to traumatic events, according to a new analysis.

Researchers said that a few psychological interventions, including talk therapy and school-based programs, "appear promising" for helping young people cope with the kind of trauma stemming from accidents, mass shootings and natural disasters. But so far, there are too many holes in the data to know what to recommend for children's long-term health and wellbeing, according to Meera Viswanathan from RTI International in Research Triangle Park, North Carolina, and her colleagues.

Nicole Nugent, who has studied stress disorders in kids at Warren Alpert Medical School of Brown University in Providence, Rhode Island, said one difficulty is that children get exposed to many different types of trauma, and as a result have many different treatment needs.

Nonetheless, "We can't just say, ‘Let's just not address it until we know more about the interventions that are effective,'" Nugent, who wasn't involved in the new review, told Reuters Health.

"One thing that we know doesn't work is nothing," she said.

"Something horrible happens, and (kids) think, ‘If I don't think about it, if I don't talk about it, it will go away.' And that absolutely doesn't happen."

So-called nonrelational trauma is different from interpersonal trauma, which stems from acts committed by a person the child knows, such as sexual abuse or maltreatment by a friend or family member.

The young victim in the recent Alabama hostage drama, a six-year-old known only as Ethan, who was held in an underground bunker for six days, could have suffered nonrelational trauma because he didn't have a prior relationship with his kidnapper, Viswanathan said.

In an interview today on the "Dr. Phil" television show, Ethan's mother talked about the boy's emotional state since being rescued, including his difficulty sleeping - a symptom common among both kids and adults following trauma.

Viswanathan's team analyzed 25 studies in which children who had been exposed to nonrelational trauma were assigned to a particular treatment intervention or a comparison group.

Depending on the trial, some of those children were already experiencing anxiety and other symptoms related to the trauma.

Treatment programs varied in their methods - from medication to talk therapy - as well as in their intensity and how long they lasted.

None of the studies testing medications such as antidepressants found they had a positive effect on children's mental health, according to the findings published Monday in Pediatrics.

On the other hand, youth who went through some type of talk therapy tended to do better than others who weren't treated at all - though Viswanathan called that pattern a "weak signal."

Researchers said some of what has been learned helping children who experience interpersonal trauma can be applied to young survivors of accidents and natural disasters as well.

"In the absence of other evidence," Viswanathan told Reuters Health, "certainly don't ignore the problem. Provide children with the support that can be available, and also tailor it for the needs of the children."

She urged for more research looking at how kids respond to nonrelational trauma, in particular.

"Sadly, the shootings in Newtown are unlikely to be the last that we see, and we don't want to be in a position that we wish we had better evidence" on how to help children move on.

SOURCE: bit.ly/XAOQ3Z Pediatrics, online February 11, 2013.

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Vitamin D supplement labels may be inaccurate

By Genevra Pittman

NEW YORK | Wed Feb 13, 2013 4:39pm EST

NEW YORK (Reuters Health) - The amount of vitamin D in some supplements may be either much lower or much higher than what's written on the label, according to a new analysis.

Researchers found that off-the-shelf pills from 12 different manufacturers had between 52 percent and 135 percent of their advertised vitamin D content.

And among vitamins mixed by compounding pharmacies, the variation in doses was even greater - from 23 percent to 146 percent of the labeled amount.

"I'm not at all surprised that they're very variable," said Dr. Pieter Cohen, who studies dietary supplements at Harvard Medical School in Boston but wasn't involved in the new research.

"When you need a supplement to work, it's really hard to find one that does," he added - in part because of lax regulation.

Vitamin D supplements can be bought for a few dollars per month.

Together with calcium, they have been tied to improved bone health. Other medical claims made for extra vitamin D - such as its ability to lower blood pressure or boost immunity - are more tenuous.

For the new study, Dr. Erin LeBlanc from the Kaiser Permanente Center for Health Research in Portland, Oregon, and her colleagues chemically analyzed pills from 15 vitamin D bottles purchased at local stores and two doses of compounded vitamins.

Supplement bottles were labeled as containing 1,000, 5,000 or 10,000 international units (IU) of vitamin D. Just one-fourth of the vitamins met the standard of all pills falling between 90 and 120 percent of the expected dose, based on a random selection of five pills per bottle.

Pills made by the one manufacturer that was verified by the U.S. Pharmacopeial Convention (USP) - a third-party tester - were all within six percent of the listed dose, LeBlanc and her colleagues found.

"Consumers buying those products can be more assured that what they're getting in their pills is what's labeled," she said.

Compounded vitamin D pills were marked as 1,000 or 50,000 IU. Those high-dose vitamins can be prescribed by doctors and are mixed by pharmacies, unlike the store-bought brands.

One-third of the pills met the slightly stricter dosing standards for compounded vitamins, according to the findings published this week in JAMA Internal Medicine.

Compounding pharmacies have come under the microscope in recent months after a meningitis outbreak was tied to injectable steroids made by the New England Compounding Center in Framingham, Massachusetts.

LOOSE MANUFACTURING STANDARDS

For most adults, the recommended daily allowance of vitamin D is 600 to 800 IU.

However, people who are deficient in vitamin D are sometimes prescribed high doses to boost the amount in their blood.

"I'm a physician, so I've told my patients to take vitamin D, and I guess I always just figured that if they were taking it from a bottle, they would get the amount that was listed on the label," LeBlanc told Reuters Health.

The main concern with such wide variability, she added, is that people with low vitamin D levels who rely on supplements may end up consistently getting less of the vitamin than is labeled in some cases.

Cohen said laws regulating supplements are often not strictly enforced, so companies can get away with spending less on manufacturing standards at the expense of quality and consistency.

He told Reuters Health the best way for consumers to get supplements with the correct dose of ingredients is to purchase brands with a seal from USP or NSF International, another third-party verifier.

SOURCE: bit.ly/Uep1H1 JAMA Internal Medicine, online February 11, 2013.

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Actelion sees Opsumit on U.S. market this year

ZURICH | Thu Feb 14, 2013 2:24am EST

ZURICH (Reuters) - Europe's biggest biotech expects it new heart and lung drug Opsumit to be on sale in the United States this year if it receives approval from regulators in October.

"The assumption is that we will be on the market with macitentan (Opsumit) in the U.S. this year," Chief Financial Officer Andrew Oakley told Reuters in an interview.

Actelion is banking on Opsumit, also known as macitentan, to reduce its dependency on its main product Tracleer, which goes off patent in 2015 and is also facing competition in the U.S. from Gilead's Letairis.

U.S. health regulators are expected to make a decision in October.

Spokesman Roland Haefeli declined to comment on the pricing of Opsumit, saying details would be announced when the drug is launched.

Actelion posted full-year net profit of 303 million Swiss francs ($330 million), in line with a forecast for 303 in a Reuters poll, and said it would hike its dividend by 25 percent.

(Reporting by Caroline Copley)

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More U.S. women using the "morning-after" pill: report

By Susan Heavey

WASHINGTON | Thu Feb 14, 2013 12:10am EST

WASHINGTON (Reuters) - More U.S. women are taking the "morning-after" pill, but generally just once, according to the government's first report on how the emergency contraception drug has been used since regulators eased access to it in 2006.

About 11 percent of sexually active women, or 5.8 million, used the pill between 2006 and 2010, compared to about 4 percent in 2002, the Centers for Disease Control and Prevention said in its report released on Thursday.

Among those who used the pill during those four years, 59 percent said they took it just once, while 24 percent said they used it twice, the report said. Seventeen percent said they used it three times or more.

Emergency contraception has been available by prescription in the United States since 1999. One version of the morning-after pill, known as Plan B, has stirred the most political controversy.

Plan B, much like regular birth control, stops pregnancy by blocking the release of a woman's egg, or it may prevent fertilization or implantation in the uterus. But it must be taken within days after intercourse to work.

The U.S. Food and Drug Administration approved sales of Plan B to adult women without a prescription in 2006 after years of contentious debate. It later loosened the restriction to include 17-year-olds.

Women's health groups lauded the move as a way to prevent unwanted pregnancies. But conservatives warned it could lead to promiscuity, especially among youth, and more sexual assaults.

Amy Allina of the National Women's Health Network said CDC's findings show morning-after pills are not replacing conventional birth control methods for most women, although "there are some for whom it's clearly not a one-time thing."

Activists are still pressing for over-the-counter access and no age restrictions.

The pill is sold by Teva Pharmaceutical Industries Ltd as Plan B. It also is available as a generic. In 2010 the FDA approved another emergency contraceptive called ella, a prescription drug now owned by Actavis Inc.

RACE, EDUCATION

CDC's findings showed the reasons for emergency contraception use varied depending on race and education levels.

Hispanics and blacks were more likely than whites to report using the drug after unprotected sex. More white women said they used it because they were worried their other birth control method had failed, CDC said.

Those with at least some college education were more likely to use the pill than those with a high school education or less, according to the report, which is based on data from the CDC's National Survey of Family Growth.

"The women who are less likely to have access to healthcare are more likely to say 'I didn't use another method, and I turned to emergency contraception to protect myself,'" said Allina.

Some women may choose to use it occasionally if they cannot afford other methods, she added.

In a separate report on Thursday, CDC looked at overall contraceptive use and found that while the number of women using regular birth control pills has remained flat over time, the use of injections, patches and intrauterine devices has grown.

The number of women whose partners have used condoms also rose, the findings showed.

That trend may reflect increased wariness among Americans to have children amid the 2007-2009 economic recession, the effects of which are still being felt by many, according to researchers at the Guttmacher Institute, which also tracks birth control use.

"At the same time, it can make it harder for people to have access to birth control because of costs," especially for disadvantaged women who face higher rates of unintended pregnancies, said Lawrence Finer, head of domestic research for the reproductive research group.

That situation could change in the wake of the 2010 healthcare overhaul that required health insurers to begin covering birth control last year, although the law faces legal challenges.

Religious groups, particularly Catholics, charge that the provision violates their belief against artificial birth control and are fighting to block it.

(Reporting by Susan Heavey; Editing by Xavier Briand)

View the original article here