NEW YORK (Reuters Health) – Antibiotics are still better than probiotics at preventing urinary tract infections, but at least “good bacteria” don’t add to a person’s antibiotic resistance, a new study concludes.

Recurring UTIs are common among some women and low-dose antibiotics are sometimes used to prevent them. The worry is that overuse of the drugs also reduces their effectiveness by making disease-causing bacteria like E. coli resistant.

“This is an increasing worldwide problem, resulting into less and less treatment options for (severe) bacterial infections in all countries of the world,” Dr. Suzanne Geerlings, from the Academic Medical Center at the University of Amsterdam in The Netherlands and one of the new study’s authors, wrote in an email to Reuters Health.

Geerlings and her colleagues recruited 252 women between January 2005 and September 2007 for a trial to compare the use of antibiotics and probiotics to prevent UTIs.

The participants, who lived in communities surrounding the medical center, were all postmenopausal — a time when vulnerability to UTIs increases because of hormonal changes, according to the researchers.

All the participants reported having had at least three UTIs in the year before the trial began, and the average number was seven.

The women were separated into two groups of about the same size. One group took a single dose of the antibiotic co-trimoxazole (Bactrim, Septra and others) every day for twelve months, while the other group took two capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, both types of beneficial bacteria, daily.

All the participants also took placebo pills so the patients and the people dispensing the pills wouldn’t know who received which treatment — to minimize any influence on the study’s results.

The researchers then tracked how many UTIs occurred in each group of women over a year. They also collected vaginal swabs and samples of the women’s urine and feces every month to test for the presence of good bacteria and infection-causing bacteria like E. coli.

In addition, women took a monthly survey asking about symptoms of UTIs, side effects, other infections and antibiotic use.

Overall, the antibiotics were slightly better at keeping UTIs at bay.

About 69 percent of the women in the group taking the antibiotic had one or more UTIs within the year. On average, the antibiotic group had 2.9 UTIs per woman.

As for the probiotic group, about 79 percent had a UTI within the year, with an average of 3.3 UTIs per woman.

The women taking the antibiotic also seemed to go twice as long without a UTI — six months, compared with three months among women taking the probiotics.

Based on the women’s urine and feces samples, however, resistance to a range of antibiotics seemed to increase within the first month in the antibiotic group.

Before the study, about 20 percent to 40 percent of E. coli in samples from all the women’s bodies were resistant to co-trimoxazole.

At the 12-month mark, between 80 percent and 95 percent of the bacteria were resistant in the women taking the antibiotic.

Rates of resistant E. coli were slightly lower at 12 months in women taking the probiotics than when the study began.

Similar changes in antibiotic resistance were seen for a range of other antibiotics, including ciprofloxacin and gentamicin, among both groups of women — which the researchers speculate might be because the same mechanism in certain bacteria allows them to resist several different drugs.

The absence of increased resistance among women taking the probiotics means that “lactobacilli may be an acceptable alternative for prevention of UTIs, especially in women who dislike taking antibiotics,” the researchers wrote in the Archives of Internal Medicine.

The study, however, had several limitations.

More than 80 women dropped out of the study by the end of the year because of side effects and other reasons. A greater number of those taking the probiotics had diarrhea compared to those taking the antibiotics, for instance. Other reasons for dropping out included the participant not thinking the treatment was working, or she couldn’t adhere to study’s directions.

As a result, the researchers did not have the number of participants in each group they would have liked to give the findings statistical weight.

Despite the study’s weaknesses, a commentary published in the same journal called the findings “exciting and compelling.”

“I think we need to appreciate that the normal flora in our body is another system we need for good health and antibiotics disrupt it and leave lasting effects… We need to think of antibiotics as a situation that has some risk,” Dr. Barbara Trautner, one of the commentary’s authors, told Reuters Health.

Trautner, of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, said that probiotics may be an acceptable alternative but they need further exploration.

Topical estrogen creams are sometimes used to prevent UTIs in menopausal women, but many women prefer to avoid using hormones.

In her commentary, Trautner wrote that 60 percent of women in the United States experience UTIs or bladder infections during their lifetimes, and they recur in about a third of those women.

“We don’t have terrific preventive strategies so a probiotic approach would be beneficial and promising,” Trautner said.

For right now, she said most women with recurring UTIs have exhausted any type of behavioral changes that might help prevent the infections, and are left with low-dose antibiotics as their only recourse.

SOURCE: bit.ly/JUywUA and bit.ly/JUyDzE Archives of Internal Medicine, May 2012.

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By Susan Heavey

WASHINGTON |
Fri May 18, 2012 2:15pm EDT

WASHINGTON (Reuters) – The Obama administration’s top health official on Friday took the debate over whether healthcare coverage should include contraceptives to the campus of a Catholic university that has been deeply divided over the administration’s policy.

U.S. Health Secretary Kathleen Sebelius, in a speech at Georgetown University a few miles from the White House, praised the new U.S. healthcare law requiring coverage and called for “conversation and compromise.”

Sebelius has become the public face for the contraception rules issued earlier this year that have provoked fierce backlash from Catholic Church officials, political conservatives and anti-abortion advocates. The issue has become a point of debate in the U.S. presidential race.

Sebelius’ presence on campus drew fire in recent days from church leaders and religious groups, who criticized her selection. Some of them called on Georgetown to rescind her speaking invitation.

About 20 protesters lined a campus entrance amid beefed up security, and a heckler, who interrupted Sebelius by calling her a “baby killer,” was led away by campus police.

In her speech, Sebelius acknowledged the deep, continuing debate over what she called “the intersection of our nation’s long tradition of religious freedom with policy decisions that affect the general public.”

Such contentious policy debates, however, are the strength of the American system, she said. She called on the graduating public policy students to take on tough debates but also to “see issues from other points of view, and in the end, follow your own moral compass.”

“Our system is messier, slower, more frustrating and far better. It requires conversations that can be painful and it almost always ends in compromise,” she told about 1,200 students and family members.

“But it’s through this process of conversation and compromise that we move forward, together, step by step, towards a more perfect union,” she said.

In a letter earlier this week, the Archdiocese of Washington criticized the university for ignoring what it said was the administration’s “direct challenge to religious liberty.”

The Becket Fund, a religious legal advocacy firm that is handling several lawsuits against the White House over the contraceptives issue, also started an online petition that drew more than 10,000 signatures.

Students of Georgetown’s Public Policy Institute elected Sebelius as their speaker for an awards ceremony following the commencement while students and faculty wrote letters supporting her attendance as a policy expert. Georgetown President John DeGioia said Sebelius’ invitation was not an endorsement of her views.

Sebelius has ties to the university – her husband and one of her sons are Georgetown graduates.

President Barack Obama’s 2010 healthcare overhaul aims to expand health insurance coverage and calls for employers to cover a wide range of preventive care, including contraception.

Churches are exempt but other religious groups, including universities, are not. Amid church protests, the administration later said health insurance companies and not the groups themselves could cover birth control.

The coverage requirement goes into effect in August but the administration is allowing a one-year grace period that it hopes will enable compromise with employers who object to the plan. Earlier this year, Georgetown’s DeGioia said the school will take the extension.

Obama’s healthcare plan has been a mixed blessing for religious leaders, who have embraced its extension of healthcare coverage for the millions of uninsured Americans.

Sebelius told the graduates about her “opportunity to help implement legislation that is finally, after seven decades of failed debate, ensuring that all Americans have access to affordable health coverage.”

That line drew heavy applause.

(Reporting by Susan Heavey; Editing by Marilyn W. Thompson and Jim Loney)

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Fri May 18, 2012 12:25pm EDT

(Reuters) – All baby boomers should be tested at least once for the liver-destroying hepatitis C virus, according to proposed guidelines from U.S. health officials released on Friday.

The often undiagnosed virus is contracted through contact with blood from an infected person. While the risk of infection has dropped dramatically since the early 1990s, many older adults are still at risk, according to the U.S. Centers for Disease Control and Prevention, which released the draft guidelines.

According to the CDC, one in 30 baby boomers – the generation born from 1945 through 1965 – has been infected with hepatitis C, and most do not know it.

The virus causes serious liver diseases, including liver cancer – the fastest-rising cause of cancer-related deaths – and is the leading cause of liver transplants in the United States.

The CDC said in a statement it believes routine testing will address the largely preventable consequences of the disease, especially in light of newly available therapies that can cure up to 75 percent of infections.

The field has attracted broad interest with two new hepatitis C drugs — Incivek from Vertex Pharmaceuticals Inc and Merck & Co’s Victrelis – reaching the U.S. market in the past year.

Companies including Gilead Sciences and Bristol-Myers Squibb aim to improve on those medicines with pills that do not need to be combined with injections of immune system boosters, which have side effects that can deter patients.

More than 15,000 Americans, most of them baby boomers, die each year from hepatitis C-related illness, such as cirrhosis and liver cancer.

Current U.S. guidelines call for testing only individuals with certain known risk factors for hepatitis C infection.

The CDC said it will accept public comment on the draft recommendations from May 22 to June 8.

(Reporting By Deena Beasley; editing by John Wallace)

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By Kerry Grens

NEW YORK |
Fri May 18, 2012 12:24pm EDT

NEW YORK (Reuters Health) – High school kids in California, a state that limits the junk food sold in vending machines, eat fewer calories in school than kids in states without such regulations, according to a new study.

“We were definitely pleased by the size of the differences, particularly for calories and sugar,” said Daniel Taber, the study’s lead author and a professor at the University of Illinois at Chicago.

The study doesn’t show that students are necessarily replacing unhealthy foods with healthier ones, but the California law “was a bold first step” to improving children’s diets, said Patricia Crawford, a professor at the University of California, Berkeley, who was not involved in the study.

Several years ago, California mandated that schools offer so-called competitive food — that is, food sold in vending machines or other sources outside of the school lunch service — that meets calorie, fat and sugar limits.

Each snack has to have fewer than 250 calories, no more than 35 percent of calories from fat and no more than 35 percent of its weight from added sugars.

To determine what impact California’s regulations have had on students’ diets, Taber and his colleagues compared how much children in California ate each day to kids who lived in 14 states that did not have such limits on the foods sold in school.

The study — published in the Archives of Pediatrics and Adolescent Medicine — used survey information, collected in the first half of 2010, from more than 100 kids who lived in California and about 560 kids who lived in other states.

The researchers found that the California kids ate 158 fewer calories each day than the other kids, primarily because they ate fewer calories during school hours.

Although the study did not look at whether kids’ diets had an impact on their health, “a difference of 158 calories can go a long way toward preventing excess weight gain, particularly if students maintain a healthy level of physical activity,” according to Taber.

The California children also ate 17 fewer grams of sugar than the other kids.

“These laws were specifically designed to improve students’ intake at school, and that is exactly what the evidence suggests they achieved,” Taber told Reuters Health in an email.

The kids don’t necessarily choose healthy foods over unhealthy foods, however.

The Californians ate the same proportion of vitamins and minerals as the kids from other states.

“All states could focus on providing more healthy foods in schools, in addition to banning high-fat, high-sugar, high-calorie foods and beverages,” said Taber.

Taber said other states have taken action to restrict the least healthy foods in school, but California has been the one of the most ambitious in terms of also offering healthier foods.

“They should definitely be applauded for their actions. But I think the lesson is that even their laws were only a starting point,” Taber said.

The U.S. Department of Agriculture (USDA) is developing federal standards for what foods kids would have access to in vending machines or from a la carte lines at schools.

A recent poll found that most parents support the stricter guidelines (see Reuters Health story of April 19, 2012).

The USDA has already set standards for school lunches that are expected to make the meals healthier.

Crawford said the study is a good first step in examining the dietary benefits of California’s laws.

“I’m glad they did the first step here to look at the nutritional benefits,” she told Reuters Health. “Because they are benefits, we just need to go further.”

SOURCE: bit.ly/KfPcUS Archives of Pediatrics and Adolescent Medicine, May 2012.

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By Amy Norton

NEW YORK |
Fri May 18, 2012 12:05pm EDT

NEW YORK (Reuters Health) – Some parents swear by fish oil as a treatment for the “tics” caused by Tourette’s disorder, but so far the research evidence is slim.

In a small study of children with Tourette’s, researchers found that omega-3 fatty acids were no better than a placebo at reducing the severity of tics — the sudden, involuntary movements or vocalizations that mark Tourette’s.

On the other hand, children who took omega-3 did show an improvement in the degree to which their tics bothered them, researchers report in the journal Pediatrics.

For now, it’s not clear what to make of the findings, according to lead researcher Dr. Vilma Gabbay, of the NYU Child Study Center in New York City and the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York.

It’s possible that the omega-3 supplements affected the children’s well-being, said Gabbay.

There is evidence, for example, that omega-3s can help lift depression symptoms.

But the study was small and had other limitations. And the bottom line, Gabbay said, is that larger trials are needed to see whether there might be a role for omega-3 supplements in managing Tourette’s.

The condition, also known as Tourette syndrome, is a neurological disorder that affects about one percent of the population. The characteristic tics usually start in childhood, and include actions like repeated throat-clearing, rapid blinking or mouth twitching.

Despite the popular media image, most people with Tourette’s do not uncontrollably hurl obscenities or slurs.

Many children with Tourette’s do not need any special treatment. But some kids have symptoms that interfere with their daily life, or have additional conditions that may warrant treatment, such as obsessive-compulsive disorder.

“The problem is, the medications currently used are very hard to tolerate, or sometimes just don’t work,” Gabbay told Reuters Health.

Some of those medications include antidepressants, anti-seizure drugs and antipsychotics. Their side effects can range from weight gain to fatigue to depression.

Anecdotally, Gabbay said, some parents have claimed that omega-3 supplements help control their children’s tics.

Omega-3 fatty acids are found largely in oily fish, like salmon, mackerel and tuna — as well as fish oil pills.

There are biological reasons to believe that omega-3s could help quiet Tourette’s tics, Gabbay said. Lab research suggests, for example, that the fats affect certain brain chemicals involved in nerve-cell communication and inflammation, and also thought to be involved in Tourette’s.

But this is the first clinical trial to pit fish oil against a placebo to test it objectively.

Gabbay and her colleagues randomly assigned 33 children and teenagers with Tourette’s to take either fish oil capsules or placebo capsules that contained olive oil. Depending on their age, the kids on fish oil took 500 or 1,000 milligrams of omega-3 a day.

After 20 weeks, the study found, kids in both groups were showing improvements in their tic severity. But the fish-oil group did no better than the placebo group.

However, kids on fish oil were more likely to report improvements in well-being and the impact their tics were having on their lives.

More than half were considered “responders” on that front, versus between one-quarter and one-third of kids in the placebo group.

Exactly what all that means is unclear.

It’s possible, according to Gabbay, that omega-3s affected how kids perceived their tics, even though there was no clear effect on tic severity.

But, she said, “I’m not going to tell parents that omega-3s are the magic pill.”

A larger clinical trial is needed, according to Gabbay. And it would probably be wise to use a different placebo, she noted.

Olive oil is not an ideal placebo, Gabbay explained, because it can indirectly affect the body’s levels of omega-3 fatty acids.

Something like corn oil would be a “better placebo,” she said.

For now, Gabbay recommended that parents pay attention to the amount of omega-3 fatty acids in their children’s diets. If you can get them to eat more fish, that would be a good way to boost their omega-3 intake.

The typical American diet, including that of kids, tends to be low in omega-3 and high in omega-6 fats — which are found in margarine, vegetable oils and an array of snack foods, sweets and fast food. And that imbalance is thought to be generally unhealthy, Gabbay pointed out.

If you can’t get your child with Tourette’s to eat fish, omega-3 capsules might be worth a shot, according to Gabbay. “But don’t have the expectation that it will benefit tic severity,” she said.

A month’s supply of one-gram fish oil capsules can run well over $15.

The supplements seem to be generally safe, Gabbay noted. She and her colleagues found no higher risk of side effects in kids using fish oil compared with the placebo group.

SOURCE: bit.ly/KfHQAV Pediatrics, online May 14, 2012.

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By Ben Hirschler

LONDON |
Fri May 18, 2012 8:40am EDT

LONDON (Reuters) – International drugmakers are working with European authorities on emergency plans to keep medicines flowing into Greece if the country crashes out of the euro.

Discussions have intensified in recent days, according to industry sources, and manufacturers are looking closely at the experience of Argentina’s collapse in 2002, when some firms agreed to continue to supply medicines without payment for a period of time.

Executives at leading drug companies – particularly those with European headquarters – are under pressure to avert a health catastrophe, which could occur if Greek imports are halted by a massive devaluation of newly issued drachma.

“There’s a moral obligation to continue to supply,” said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.

“Greece is not a big market, so most drug companies can absorb it … the reputational damage would, I think, more than outweigh the economic cost.”

Although plans are still in flux, the idea is to have a scheme ready for implementation at short notice that could bridge the gap by supplying critical medicines for a few months, according to one person familiar with the situation.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, confirmed his group was discussing the Greek situation but declined to go into details.

“We obviously are on alert and talking to people about it,” he said. “We are in very close contact with the European Commission and the Greece task force and we are monitoring developments.”

The European Union set up the task force last year under Horst Reichenbach to help Athens tackle its debt crisis.

Greece imports nearly all its medicines and is particularly reliant on branded drugs, as opposed to cheaper generics, which means it spends a relatively large amount per capita on medicines.

Any short-term initiative might be limited to certain categories of essential medicines and would probably not be a panacea, reflecting the need of companies to protect the interests of shareholders as well as patients.

Certain parts of the Greek healthcare system have already experienced drug shortages in recent months and drug manufacturers – owed 1.21 billion euros in unpaid bills from Greek state hospitals, according to the Hellenic Association of Pharmaceutical Companies – have adopted a range of strategies to limit exposure to an uncertain market.

Some, like Denmark’s Novo Nordisk, the world’s largest supplier of insulin for diabetics, have long demanded payment on delivery. Others, including Britain’s GlaxoSmithKline, say they have not changed the terms of business and are not demanding immediate cash settlement.

Swiss-based Roche, the world’s largest maker of cancer drugs, has a nuanced approach. It switched last year to a system of payment on delivery for hospitals with a history of bad payments but spokesman Daniel Grotzky said this policy did not apply to critical products like HIV drugs and CellCept, a medicine given to organ transplantation patients.

Drugmakers know from experience that turning off the supply tap may simply not be an option. Two years, Novo Nordisk was hit by storm of protest when it halted deliveries of certain insulins for around a month after Greece cut the price by more than a quarter. The cut-off ended when Athens agreed to somewhat smaller price cuts.

Greece represents just under 1 percent of the world drugs market but it has a potentially wider impact because the country is embedded in the European Union.

As a result, price cuts in Greece can trigger automatic cuts in richer countries through the practice of “reference pricing” to other countries – something industry is keen to avoid if Greece leaves the euro and prices in euro terms fall heavily.

Drug price cuts over the past two years have also helped suck medicines out of the country as wholesalers sell supplies to countries – like Germany – where drug prices are higher, although recently introduced quotas limiting exports of some drugs have tried to address this.

Such parallel trade is allowed under European free trade rules and can help keep costs down for European healthcare systems, according to the European Association of Euro-Pharmaceutical Companies, representing wholesalers involved in the practice.

Drug manufacturers, however, see it as a thorn in their side and any short-term emergency supply plan for Greece is likely to include a demand for assurances that drug deliveries will actually get to Greek patients. Fraud over medicine reimbursement in Greece is another concern.

On the ground, meanwhile, many patients are already struggling to get the prescription medicines they need, according to Apostolos Veizis, head of programs for Medecins Sans Frontieres in Greece.

One reason is a liquidity crunch among pharmacists, who face delays in payments from public insurers and, as a result, are unable to pay their suppliers.

But even when drugs are available, more and more Greeks have trouble paying the 10-25 percent of the prescription cost not covered by the public healthcare system.

“We’re seeing a massive decrease in patient access because of the economic crisis,” Veizis said.

(editing by Janet McBride)

(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging:; ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/reutersBenHir)

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By Ben Hirschler

LONDON |
Fri May 18, 2012 8:40am EDT

LONDON (Reuters) – International drugmakers are working with European authorities on emergency plans to keep medicines flowing into Greece if the country crashes out of the euro.

Discussions have intensified in recent days, according to industry sources, and manufacturers are looking closely at the experience of Argentina’s collapse in 2002, when some firms agreed to continue to supply medicines without payment for a period of time.

Executives at leading drug companies – particularly those with European headquarters – are under pressure to avert a health catastrophe, which could occur if Greek imports are halted by a massive devaluation of newly issued drachma.

“There’s a moral obligation to continue to supply,” said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.

“Greece is not a big market, so most drug companies can absorb it … the reputational damage would, I think, more than outweigh the economic cost.”

Although plans are still in flux, the idea is to have a scheme ready for implementation at short notice that could bridge the gap by supplying critical medicines for a few months, according to one person familiar with the situation.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, confirmed his group was discussing the Greek situation but declined to go into details.

“We obviously are on alert and talking to people about it,” he said. “We are in very close contact with the European Commission and the Greece task force and we are monitoring developments.”

The European Union set up the task force last year under Horst Reichenbach to help Athens tackle its debt crisis.

Greece imports nearly all its medicines and is particularly reliant on branded drugs, as opposed to cheaper generics, which means it spends a relatively large amount per capita on medicines.

Any short-term initiative might be limited to certain categories of essential medicines and would probably not be a panacea, reflecting the need of companies to protect the interests of shareholders as well as patients.

Certain parts of the Greek healthcare system have already experienced drug shortages in recent months and drug manufacturers – owed 1.21 billion euros in unpaid bills from Greek state hospitals, according to the Hellenic Association of Pharmaceutical Companies – have adopted a range of strategies to limit exposure to an uncertain market.

Some, like Denmark’s Novo Nordisk, the world’s largest supplier of insulin for diabetics, have long demanded payment on delivery. Others, including Britain’s GlaxoSmithKline, say they have not changed the terms of business and are not demanding immediate cash settlement.

Swiss-based Roche, the world’s largest maker of cancer drugs, has a nuanced approach. It switched last year to a system of payment on delivery for hospitals with a history of bad payments but spokesman Daniel Grotzky said this policy did not apply to critical products like HIV drugs and CellCept, a medicine given to organ transplantation patients.

Drugmakers know from experience that turning off the supply tap may simply not be an option. Two years, Novo Nordisk was hit by storm of protest when it halted deliveries of certain insulins for around a month after Greece cut the price by more than a quarter. The cut-off ended when Athens agreed to somewhat smaller price cuts.

Greece represents just under 1 percent of the world drugs market but it has a potentially wider impact because the country is embedded in the European Union.

As a result, price cuts in Greece can trigger automatic cuts in richer countries through the practice of “reference pricing” to other countries – something industry is keen to avoid if Greece leaves the euro and prices in euro terms fall heavily.

Drug price cuts over the past two years have also helped suck medicines out of the country as wholesalers sell supplies to countries – like Germany – where drug prices are higher, although recently introduced quotas limiting exports of some drugs have tried to address this.

Such parallel trade is allowed under European free trade rules and can help keep costs down for European healthcare systems, according to the European Association of Euro-Pharmaceutical Companies, representing wholesalers involved in the practice.

Drug manufacturers, however, see it as a thorn in their side and any short-term emergency supply plan for Greece is likely to include a demand for assurances that drug deliveries will actually get to Greek patients. Fraud over medicine reimbursement in Greece is another concern.

On the ground, meanwhile, many patients are already struggling to get the prescription medicines they need, according to Apostolos Veizis, head of programs for Medecins Sans Frontieres in Greece.

One reason is a liquidity crunch among pharmacists, who face delays in payments from public insurers and, as a result, are unable to pay their suppliers.

But even when drugs are available, more and more Greeks have trouble paying the 10-25 percent of the prescription cost not covered by the public healthcare system.

“We’re seeing a massive decrease in patient access because of the economic crisis,” Veizis said.

(editing by Janet McBride)

(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging:; ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/reutersBenHir)

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By Andrew M. Seaman

NEW YORK |
Fri May 18, 2012 2:05am EDT

NEW YORK (Reuters Health) – Babies who are fed milk from their mothers’ breasts gain less weight over their first year compared to babies fed milk — breast or formula — from a bottle, suggests a new study.

The lead author said the difference may come down to how much of a role babies play in deciding when to stop feeding, instead of mothers or fathers forcing them to finish a bottle.

“If the babies are fed by the breast, the baby plays a very active role, because they are the ones who decide when to suckle and when to stop,” said Dr. Ruowei Li, of the United States Centers for Disease Control and Prevention in Atlanta.

Li told Reuters Health some researchers believe that “if the babies are fed with the bottle, they will gradually lose their self-regulation of their energy intake and the internal cues of satiety and hunger.”

To look at the link between weight gain and feeding, Li and her fellow researchers followed about 1,900 babies from across the U.S. born in the mid-2000s.

Through a series of surveys sent to their mothers, the researchers asked for — among other things — babies’ weights at different ages and how often women breastfed, pumped their breast milk or used formula.

Babies who were only fed from a bottle — either with only breast milk or only formula — gained about three ounces more per month compared to those who were solely breastfed.

After that, the findings got a bit complicated.

When moms did a combination of breastfeeding and bottle feeding with human milk only, babies didn’t gain any extra weight — but if they both breastfed and bottle-fed with formula, their babies gained an additional two ounces each month, on average.

And when moms exclusively bottle-fed, but alternated between using human milk and formula, their babies grew similarly to solely-breastfed babies.

It’s not totally clear why babies fed a combination of bottled breast milk and formula may not have gained additional weight, the researchers wrote in the Archives of Pediatrics & Adolescent Medicine.

But, “The key message out of this study is that breastfeeding really is the first feeding choice for the babies,” said Li, who added that supplementing breastfeeding with breast milk from a bottle is a good second option.

MOUNTING EVIDENCE

The new study is only a piece of the growing evidence that breastfeeding appears to be the best choice for a newborn, and may protect against obesity later in life.

In the same journal, Tessa Crume and her colleagues published findings suggesting breastfeeding for at least six months may not only protect kids against being overweight later in childhood, but also against being underweight.

Simply put, overweight kids might have been even more overweight if they weren’t breastfed as babies, the researchers reported. At the opposite end of the weight spectrum, there was a suggestion that underweight kids might have weighed even less if their moms hadn’t breastfed them.

Those findings are based on weight and body fat measurements, as well as breastfeeding history, for 442 children between the ages of six and 13 years old.

“It is suggesting that breastfeeding has a growth-regulating effect — preventing extremes,” said Crume, from the Colorado School of Public Health at the University of Colorado in Denver.

IN AN IDEAL WORLD

Despite growing research in favor of breastfeeding, the authors of a linked commentary say the new findings may put too much pressure on new mothers.

“Pediatricians should deliver their expert advice with empathy, being mindful of the gap that always exists for parents between doing what is ideal for their children and doing what is possible,” according to the editorial.

Co-author Dr. Jeffrey Wright, a pediatrician from the University of Washington School of Medicine in Seattle, told Reuters Health there could be anatomical or economic reasons why mothers cannot breastfeed their children.

Some mothers have to return to work, fathers may want to help with feeding and the parents may want to know how much milk their baby is getting. Wright said all of these reasons may keep mothers from breastfeeding.

The American Academy of Pediatrics recommends mothers exclusively breastfeed for six months, and continue breastfeeding as foods are introduced until at least 12 months.

“There were millions of babies raised on formula well before the obesity epidemic started,” said Wright. “Each family should weigh the benefits they see against the hassles they take to get there, and the father should be involved with that discussion.”

As with any research, the new studies also have limitations — including that neither can prove breastfeeding directly protects kids from gaining too much weight.

But researchers agreed that employers need to do what they can to promote breastfeeding, such as having onsite child care and allowing new parents to work part-time.

“Breastfeeding is really the best feeding for the babies, and needs to be the first choice,” said Li.

If that’s not possible, she said it’s important to pay attention to the signals a baby sends out to prevent overfeeding with a bottle, such as keeping their mouth shut or not wanting to suckle.

SOURCE: bit.ly/Jjpti1> <bit.ly/J3i4PS and bit.ly/KwzHvx Archives of Pediatrics and Adolescent Medicine, online May 7, 2012.

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By Toni Clarke

BOSTON |
Thu May 17, 2012 9:57pm EDT

BOSTON (Reuters) – Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD — those who have more or less failed all other therapies — Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

FDA SUBMISSION THIS YEAR

Osiris, which is based in Columbia, Maryland, plans to apply for marketing authorization with the U.S. Food and Drug Administration by the end of this year, including the newly-analyzed information. Mills said that if the FDA were to approve the drug, he would expect it to be on similarly conditional terms as outlined by the Canadian authorities.

In general, the FDA does not approve drugs based on subset analyses.

Prochymal is made up of bone marrow stem cells derived from an adult donor and is designed to control inflammation, promote tissue regeneration and prevent scar formation. It is not entirely clear how it works to help patients with GvHD, of which there are between 3,500 to 4,000 worldwide, Mills said.

Osiris said it will receive at least eight years of exclusivity in the Canadian market. But competition is heating up elsewhere.

Athersys Inc said last month it had met with the FDA to discuss the results of a recently completed clinical trial of its MultiStem stem cell treatment to prevent GvHD in patients being treated for leukemia or other conditions that place them at risk of the complication.

Dozens of adult stem cell therapies are moving through clinical trials, and Canada’s approval of Osiris’s drug will likely boost optimism in the sector. Stem cells derived from adult tissue such as fat or bone marrow circumvent the ethical concerns raised by the use of cells derived from embryos.

In 2008, Genzyme Corp, which is now owned by Sanofi SA, paid $130 million to Osiris and agreed to pay up to $1.25 billion more if Prochymal and another Osiris drug, Chondrogen, designed to repair tissue in damaged knees, reached the market and achieved certain sales levels.

In February, Sanofi said it had discontinued its project with Prochymal. Osiris said the statement was issued without its consultation and that it had not received notice from Sanofi regarding the discontinuation. However, the company said that the agreement between the two companies provides that in this instance all rights to Prochymal revert to Osiris without compensation to Sanofi.

(Reporting By Toni Clarke; Editing by Tim Dobbyn, Bernard Orr)

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By Kate Kelland

LONDON |
Thu May 17, 2012 8:38pm EDT

LONDON (Reuters) – An experimental cancer drug developed by Britain’s GlaxoSmithKline may add vital months to the lives of melanoma patients whose disease has spread to their brains, according to data from an early-stage trial published on Friday.

Results of Phase I trial published in The Lancet medical journal showed substantial shrinking of tumors in patients treated with the drug, dabrafenib, and showed promise against secondary melanoma tumors, or metastases, in the brain.

Dabrafenib blocks the activity of a cancer-causing mutated form of a gene known as BRAF, which is found in about half of melanoma cases.

Results released on Wednesday from a separate trial looking at dabrafenib in combination with another GSK drug, trametinib, were also positive.

Researchers said the results of the dabrafenib-only trial, although early-stage, represented an important step forward in the treatment of this deadly cancer.

Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months.

Georgina Long of the Melanoma Institute Australia and Westmead Hospital in Sydney, and Gerald Falchook from the University of Texas in the United States, treated 184 patients with dabrafenib in a Phase I trial — the earliest step of the drug development process in humans.

They said some of the most exciting results came from a subset of 10 patients whose tumors had spread to their brains.

None of these had previously received treatment for their brain tumors. However, the brain metastases disappeared in four of the patients when they were treated with 150 milligrams of dabrafenib twice daily.

Five patients saw their brain metastases shrink, and one had stable disease, where the tumors remained the same size.

“The results in the brain were remarkable,” Long said. “I don’t think there is a single other systemic agent that is as active in the brain.”

Experts not involved in the trial also said the drug showed promise.

In a commentary piece in The Lancet, Geoffrey Gibney and Vernon Sondak from the H Lee Moffit Cancer Center and Research Institute in the U.S. described the results as “impressive” and “encouraging”.

Long and Falchook said it was not clear why the drug was so effective in the brain where other drugs have failed, but further trials are under way to try to clarify the mechanism.

“The big message is that the brain, with this drug, is just like another organ,” Long said. “If you are going to respond in your lung and liver, you tend to respond in your brain as well.”

Unfortunately, for most of the patients with brain metastases, the response to the drug was limited to several months.

Long said, however, these few months of extension of life were very rare in patients with melanoma that has spread to the brain. Normally, such patients can only expect to survive for four months from the point of diagnosis, she said.

“With this drug, these patients had no progression of their disease for a median of 4.2 months. Without treatment, many of them might already have died at that point,” she said.

Two of the 10 brain metastasis patients who received the drug survived for more than 12 months. One was still alive and receiving the drug at 19 months.

(Editing by David Hulmes)

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