CHICAGO (Reuters) – Birth and abortion rates among U.S. teens fell to record lows in 2008 as increased use of contraceptives sent the overall teen pregnancy rate to its lowest level since at least 1972, a study showed on Wednesday.

But disparities among racial and ethnic groups continued to persist, with black and Hispanic teens experiencing pregnancy and abortion rates two to four times higher than their white peers, the Guttmacher Institute, the nonprofit sexual health research group that conducted the analysis, said.

The Guttmacher researchers looked at government statistics on teen-age sex, pregnancies and births, as well as the institute’s own data on abortions for 2008, the most recent year for which all the numbers were available.

They found that nearly 750,000 U.S. women under the age of 20 became pregnant in 2008 — nearly 98 percent of them between the ages of 15 and 19.

That translated into a pregnancy rate of 67.8 pregnancies per 1,000 women aged 15 to 19, the researchers said, the lowest pregnancy rate seen since 1972, the year before the Supreme Court decision in Roe v. Wade that established a woman’s right to an abortion.

It was also down 42 percent from 1990, when teen pregnancies peaked at 116.9 per 1,000 teen girls and women.

The teen abortion rate in 2008 dropped to the lowest rate seen since 1972 at 17.8 per 1,000 teen girls and women, the analysis found, and was down 59 percent from 1988 when the abortion rate peaked at 43.5 per 1,000 teen women.

The Guttmacher researchers said the decline in teen birthrates was largely attributable to increased contraceptive use by teens of both genders.

“Teens are also using more effective forms of contraception,” said Kathryn Kost, a demographer with the Guttmacher Institute who co-authored the analysis.

Among women aged 15 to 17, about a quarter of the long-term decline in pregnancies, births and abortions could be attributable to reduced sexual activity, the researchers said.

But pregnancy, birth and abortion rates remained much higher for teens who belonged to minority groups, even though their overall rates have fallen over the past four decades.

Birth rates for black and Hispanic teens were more than twice those of their white peers in 2008, the researchers found. The abortion rate among black teens, meanwhile, was four times higher than the rate for their Caucasian counterparts. Abortion rates for Hispanic teens were twice as high as for their white peers.

The Guttmacher study was funded with grants from The California Wellness Foundation, The William and Flora Hewlett Foundation, The David and Lucile Packard Foundation and the Ford Foundation.

(Editing by Cynthia Johnston)

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Wed Feb 8, 2012 11:37am EST

(Reuters) – Health regulators said ulcer drugs such as AstraZeneca Plc’s blockbuster Nexium could increase the risk of clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile is a bacteria naturally present in the gut and can cause colitis and other intestinal conditions.

The Food and Drug Administration said patients who develop diarrhea after taking these drugs should be checked for CDAD.

The drugs called proton pump inhibitors (PPIs) are widely used for treating ulcers, acid reflux and other conditions.

Other PPIs sold by prescription include Takeda Pharmaceutical Co Ltd’s Dexilant and Prevacid, AstraZeneca’s Prilosec and Vimovo, Santarus Inc’s Zegerid, and Johnson & Johnson and Eisai Co Ltd’s AcipHex.

Generic versions of Prevacid and Prilosec also are available.

Details were released on the FDA website at link.reuters.com/wag56s

(Reporting by Anand Basu in Bangalore; Editing by Don Sebastian)

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WASHINGTON |
Wed Feb 8, 2012 11:27am EST

WASHINGTON (Reuters) – Three consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat.

The fish at issue, AquaBounty Technologies’ AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review.

The FDA considers any genetically altered animal a new animal drug for approval purposes. The petition calls for the salmon to be classified as a food additive instead, which would require a more rigorous FDA review.

AquaBounty is seeking U.S. approval to market its engineered Atlantic salmon, which contains a gene from another fish species, the Chinook salmon, to help it grow twice as fast as normal.

The consumer groups’ petition says the way these salmon are created substantially alters their composition and nutritional value, and so they should be treated as a food additive. Under this standard, they said, the company’s data would have to overwhelmingly prove AquAdvantage salmon are safe to eat.

The consumer groups — Food & Water Watch, Consumers Union, and the Center for Food Safety — said in a statement the “new animal drug” designation is insufficient to protect public health. The review process for food additives offers greater protection, they said.

AquaBounty had no comment on the petition.

The FDA did not comment specifically on the petition, but confirmed that the company’s application for FDA approval for AquAdvantage salmon is under review, and that genetically engineered animals are evaluated under the new animal drug provisions of U.S. law.

AquaBounty has said in the past that it sees these genetically modified salmon as a potential solution to environmental concerns associated with salmon aquaculture, and discounted fears they might accidentally escape into the wild and affect other fish.

However, Food & Water Watch Executive Director Wenonah Hauter said the company’s own study showed that genetically engineered salmon may contain increased levels of a hormone linked to breast, colon, prostate and lung cancer.

The petitioners said a proper review would require genetically engineered salmon to go through comprehensive toxicological studies to ensure the fish are safe to consume and properly labeled.

If approved, AquAdvantage would be the first genetically altered animal for human consumption in the United States.

Genetically modified vegetables such as corn have long been on the U.S. market, and the FDA allows modified animals as pets or to help produce biologic medicines.

There is no timeline for an FDA decision. As a matter of policy, the FDA does not comment on citizen petitions.

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By Elena Berton

PARIS |
Wed Feb 8, 2012 8:18am EST

PARIS (Reuters) – French drugmaker Sanofi said on Wednesday that its earnings could drop by up to 15 percent this year as top-selling drugs previously protected by patents are hit by competition from cheap copies.

Sanofi expects to return to growth in subsequent years, driven by emerging markets, diabetes, vaccines, animal health, its takeover of biotechnology company Genzyme and new products.

“The chapter on blockbusters closes, but we are in good shape coming out of the ‘patent cliff’ this year,” chief executive Chris Viehbacher told reporters on Wednesday.

The Paris-based company reported a 13 percent increase in fourth-quarter profits and fine-tuned the expected earnings dip in 2012 as blood-thinner Plavix, the world’s second-best selling medicine, and blood pressure drug Avapro shortly face competition from generic copies in the United States.

It said its business earnings per share, which exclude items like amortization and legal costs, were expected to fall 12-15 percent at constant exchange rates this year, reflecting a 1.4 billion euro ($1.85 billion) dent in business net income from the impact on the two products.

Beyond 2012, Sanofi expects sales to grow 5 percent annually and EPS to grow even faster to 2015.

Fourth-quarter business net income rose to 2.08 billion, in line with analysts’ average forecast of 2.07 billion. Sales rose 8.8 percent to 8.51 billion euros, close to the forecast of 8.54 billion, lifted by emerging markets, diabetes therapy Lantus and the contribution of Genzyme.

Quarterly sales of Lantus topped 1 billion euros for the first time, driven by the U.S., Japanese and emerging markets.

The company raised its dividend on 2011 profit to 2.65 euros from 2.50 euros for the year earlier.

“Overall, a solid, quiet quarter which will help build investor credibility in the name,” said Bernstein analyst Tim Anderson in a research note.

But Natixis analyst said Sanofi’s forecasts for 2012 would prompt a negative reaction among investors.

At 1150 GMT shares were trading 1.6 percent lower at 55.58 euros, underperforming the CAC40 index, up 0.5 percent.

Unlike competitors such as AstraZeneca, which aims to buy back $4.5 billion in shares in 2012, Sanofi ruled out a large share repurchase this year.

“At this stage I don’t think a big buyback would enhance our share price,” Viehbacher told Reuters.

Sanofi has pledged reward shareholders by increasing its dividend payout ratio to 50 percent of net profit in 2014 from 35 percent in 2010.

After receiving the green light from European and U.S. regulators to begin producing rare disease drug Fabrazyme at a new plant in Framingham, Massachusetts, Sanofi plans to return to normal supply levels in the second quarter.

The supply outlook for Cerezyme, another rare disease therapy, should improve from February, it said. Both drugs have had to be rationed because of production problems.

Turning to its drug pipeline, Sanofi said three experimental medicines had moved to late-stage development; an insulin therapy, a treatment for bone marrow disorder and an influenza vaccine.

The company plans to file multiple sclerosis treatment Lemtrada with regulators in the United States and Europe in the second quarter of 2012.

Also on Wednesday, Sanofi and its partner Bristol-Myers Squibb said they had collected $442 million damages from Canadian generic drugmaker Apotex in patent litigation relating to Plavix.

($1 = 0.7552 euro)

(Editing by Dan Lalor and Will Waterman)

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By Elena Berton

PARIS |
Wed Feb 8, 2012 8:18am EST

PARIS (Reuters) – French drugmaker Sanofi said on Wednesday that its earnings could drop by up to 15 percent this year as top-selling drugs previously protected by patents are hit by competition from cheap copies.

Sanofi expects to return to growth in subsequent years, driven by emerging markets, diabetes, vaccines, animal health, its takeover of biotechnology company Genzyme and new products.

“The chapter on blockbusters closes, but we are in good shape coming out of the ‘patent cliff’ this year,” chief executive Chris Viehbacher told reporters on Wednesday.

The Paris-based company reported a 13 percent increase in fourth-quarter profits and fine-tuned the expected earnings dip in 2012 as blood-thinner Plavix, the world’s second-best selling medicine, and blood pressure drug Avapro shortly face competition from generic copies in the United States.

It said its business earnings per share, which exclude items like amortization and legal costs, were expected to fall 12-15 percent at constant exchange rates this year, reflecting a 1.4 billion euro ($1.85 billion) dent in business net income from the impact on the two products.

Beyond 2012, Sanofi expects sales to grow 5 percent annually and EPS to grow even faster to 2015.

Fourth-quarter business net income rose to 2.08 billion, in line with analysts’ average forecast of 2.07 billion. Sales rose 8.8 percent to 8.51 billion euros, close to the forecast of 8.54 billion, lifted by emerging markets, diabetes therapy Lantus and the contribution of Genzyme.

Quarterly sales of Lantus topped 1 billion euros for the first time, driven by the U.S., Japanese and emerging markets.

The company raised its dividend on 2011 profit to 2.65 euros from 2.50 euros for the year earlier.

“Overall, a solid, quiet quarter which will help build investor credibility in the name,” said Bernstein analyst Tim Anderson in a research note.

But Natixis analyst said Sanofi’s forecasts for 2012 would prompt a negative reaction among investors.

At 1150 GMT shares were trading 1.6 percent lower at 55.58 euros, underperforming the CAC40 index, up 0.5 percent.

Unlike competitors such as AstraZeneca, which aims to buy back $4.5 billion in shares in 2012, Sanofi ruled out a large share repurchase this year.

“At this stage I don’t think a big buyback would enhance our share price,” Viehbacher told Reuters.

Sanofi has pledged reward shareholders by increasing its dividend payout ratio to 50 percent of net profit in 2014 from 35 percent in 2010.

After receiving the green light from European and U.S. regulators to begin producing rare disease drug Fabrazyme at a new plant in Framingham, Massachusetts, Sanofi plans to return to normal supply levels in the second quarter.

The supply outlook for Cerezyme, another rare disease therapy, should improve from February, it said. Both drugs have had to be rationed because of production problems.

Turning to its drug pipeline, Sanofi said three experimental medicines had moved to late-stage development; an insulin therapy, a treatment for bone marrow disorder and an influenza vaccine.

The company plans to file multiple sclerosis treatment Lemtrada with regulators in the United States and Europe in the second quarter of 2012.

Also on Wednesday, Sanofi and its partner Bristol-Myers Squibb said they had collected $442 million damages from Canadian generic drugmaker Apotex in patent litigation relating to Plavix.

($1 = 0.7552 euro)

(Editing by Dan Lalor and Will Waterman)

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By Katie Reid

ZURICH |
Wed Feb 8, 2012 6:15am EST

ZURICH (Reuters) – Swiss drugmaker Roche is digging in for a long fight after gene sequencing company Illumina rejected its $5.7 billion hostile takeover bid as inadequate and said it would be more successful on its own.

Roche, which offered to pay $44.50 per share when it launched the bid for Illumina last month, reiterated on Wednesday that it believed its offer was “full and fair” and that it was ready to start discussions with Illumina.

On Tuesday, Illumina – which has already adopted a “poison pill” defense strategy – told shareholders not to tender any of their shares to Roche, saying the offer failed to properly value its existing and coming products.

A deal would give Roche’s diagnostics unit a leading position in the market for gene sequencing, which can help better identify which patients benefit from a given drug.

Although it faces a drawn-out battle for the San Diego-based group, analysts expect Roche, which has a history of success with such hostile takeouts, to prevail in the end.

“Next step for Roche could be to show the good intent, sugarcoat the deal and then start pitching the transaction to Illumina’s major shareholders. Ultimately they hold the key to close the deal,” Vontobel analyst Andrew Weiss said.

Roche initially offered $40 a share for Illumina, according to a filing with the U.S. Securities and Exchange Commission. That offer, subject to certain conditions, was made in a letter to Illumina on January 3, the filing said.

But when it announced its approach on January 25, it made an offer of $44.50.

Investors say Basel-based Roche may have to raise its bid to around $60 per share to win Illumina. Shares in Illumina, which also posted better-than-expected fourth-quarter earnings on Tuesday, closed on Tuesday at $51.80.

Roche raised offers in other bidding situations, even after it declared initial salvoes a full-and-fair value, such as for biotech company Genentech and test maker Ventana.

When chief executive Severin Schwan was diagnostics head, Roche in 2008 overcame months-long resistance from Ventana to snap it up for $3.4 billion. It had made an unsolicited, low-end bid, before increasing its original offer by 19 percent.

NO WHITE KNIGHT?

Some investors have said a rival bid is unlikely as few would be prepared to take on as determined a bidder as Roche.

“It’s hard to see anybody else emerging as a bidder. The fit is best with Roche and I don’t think any other competitor in that space would be willing to pay a higher price than Roche. Also you really need a diagnostics business to get the synergies,” Sarasin analyst David Kaegi said.

But one person familiar with the deal said if the bidding process for Illumina does drag on, this would give other interested parties time to have a good look at the company.

Roche rivals Sanofi, Novartis and AstraZeneca have said they don’t see a need to match Roche in buying a gene-decoding business, favoring partnerships instead.

Pharma industry bankers and analysts say Siemens, General Electric, Thermo Fisher Scientific, Danaher, Agilent Technologies and Johnson & Johnson are seen as potential interlopers.

Illumina is a major player in the emerging field of gene sequencing.

It makes machines that decode a person’s entire genome, going far beyond simple genetic tests that are already used in diseases such as cancer to test for a handful of gene variations.

(Additional reporting by Caroline Copley in Zurich and Douwe Miedema in London; Editing by Erica Billingham and Jodie Ginsberg)

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By Susan Heavey

WASHINGTON |
Tue Feb 7, 2012 8:50pm EST

WASHINGTON (Reuters) – The Obama administration is willing to work with Catholic universities, hospitals and other church-affiliated employers to implement a new policy that requires health insurers to offer birth control coverage, a top adviser to the president’s re-election campaign said on Tuesday.

David Axelrod, a senior campaign adviser to President Barack Obama, said the administration had heard the Roman Catholic Church’s concerns and never intended to “abridge anyone’s religious freedom.”

But he gave no sign that the administration would reverse course under intensifying pressure from church leaders and political heat from Republican presidential candidates.

“This is an important issue. It’s important for millions of women across this country. We want to resolve it in an appropriate way, and we’re going to do that,” Axelrod said in remarks on MSNBC’s “Morning Joe” program.

White House spokesman Jay Carney also sought to diffuse criticism from church leaders, telling reporters later on Tuesday the administration would work with religious organizations “to see if the implementation of the policy can be done in a way that allays some of those concerns.”

U.S. Catholic bishops have slammed the Obama administration for a regulation finalized on January 20 that would require health insurance to include birth control and other preventative health services for women. The leaders contend the policy infringes on religious liberty because the church does not condone birth control of any kind.

Over the weekend, Catholic clergy across the country called for congregations to pressure Obama to back down.

“To force American citizens to choose between violating their consciences and forgoing their healthcare is literally unconscionable,” said Cardinal-designate Timothy Dolan, archbishop of New York and president of the U.S. Conference of Catholic Bishops, in a statement last month.

Jim Towey, president of Ave Maria University in Florida, who also served in the administration of President George W. Bush, said on Tuesday he would fight the provision using “all lawful means at our disposal.”

“Our non-Catholic employees and students understand fully that the University must adhere to Catholic teaching and they do not expect us to provide such services,” he said in a statement.

REPUBLICANS SEE ASSAULT

The controversy centers on a provision in the 2010 healthcare bill which requires health insurance to cover basic preventative services for women. An advisory group, the Institute of Medicine, had recommended covering a fuller range of contraceptive services to help prevent unwanted pregnancies.

U.S. Health and Human Services Secretary Kathleen Sebelius adopted the institute’s recommendation but included an exemption for churches, although not related religious organizations such as hospitals.

Twenty-eight U.S. states already require health insurers to cover contraception.

The issue quickly took on political dimensions, with Republican presidential contenders criticizing the administration for violating religious liberties. Obama is seeking re-election in what many see as a referendum on his performance during the last three years.

Republican presidential frontrunner Mitt Romney, in Colorado on Tuesday, called the requirement an “assault on religion.”

Republican rival Rick Santorum, who is Catholic, called the White House’s comments “ridiculous” while speaking in Colorado on Monday. Rival Newt Gingrich, also a Catholic, has also declared the policy a war on religious freedom.

Florida Senator Marco Rubio, whose name has surfaced as a possible Republican vice presidential candidate, has introduced a bill to further expand the exemption for religious employers.

On Capitol Hill, the top Republican on the Senate Judiciary Committee, Senator Chuck Grassley, urged the Obama administration to rescind the provision.

“As currently written, this mandate will result in litigation that could be avoided if HHS issued a regulation that showed greater respect for religious freedom,” Grassley said in a letter to Sebelius.

In remarks on the Senate Floor, Senator Barbara Mikulski, a Maryland Democrat, said the debate was off in the wrong direction. “For the first time in a long time, our nation is talking about women’s health, … but unfortunately, too much of it isn’t really about women’s health. It is politics disguised as women’s health,” Mikulski said.

ALLAYING CONCERNS

Just how religious-based organizations could implement the rule to meet the Obama administration’s criteria while still holding fast to their core beliefs remains to be seen.

Carney offered no details but said the White House would discuss possible avenues over the next 18 months.

Jennifer Duffy, senior political analyst for The Cook Political Report, said neither side was likely to back down in the run-up to the election.

“I don’t think the bishops have any intention of letting this fade and, especially if their position is intractable, then it’s a fight,” she said. “It becomes a staring contest.”

Emergency contraception, also known as the “morning after pill” and seen by many conservatives as akin to abortion, for the most part would not fall under the rule since it is already available without a prescription to those 17 and older.

Women’s rights groups and other contraception supporters, who were disappointed last year when the Obama administration rejected a push to make emergency contraception more widely available, had feared Obama might widen the exemption.

Susan Wood, a health professor at George Washington University’s Jacobs Institute of Women’s Health who backs birth control, said religious groups should have no more control over what employees do with their insurance than with their salaries.

“This is an employee benefit issue. This is not the Catholic

Church having to provide a service directly. No Catholic hospital is going to be required to write a prescription or provide a pack of pills.”

Two polls released by Planned Parenthood, which provides birth control and reproductive services, showed the majority of voters, including Catholics, support contraceptive coverage.

(Reporting By Susan Heavey; additional reporting by Steve Holland in Colorado, Laura MacInnis in Washington and Greg McCune in Chicago; Editing by Marilyn W. Thompson, Eric Beech and Todd Eastham)

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WASHINGTON |
Tue Feb 7, 2012 8:27pm EST

WASHINGTON (Reuters) – Three U.S. consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat.

The fish at issue, AquaBounty Technologies’ AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review.

The FDA considers any genetically altered animal a new animal drug for approval purposes. The petition calls for the salmon to be classified as a food additive instead, which would require a more rigorous FDA review.

AquaBounty is seeking U.S. approval to market its engineered Atlantic salmon, which contains a gene from another fish species, the Chinook salmon, to help it grow twice as fast as normal.

The consumer groups’ petition says the way these salmon are created substantially alters their composition and nutritional value, and so they should be treated as a food additive. Under this standard, they said, the company’s data would have to overwhelmingly prove AquAdvantage salmon are safe to eat.

The consumer groups – Food & Water Watch, Consumers Union, and the Center for Food Safety – said in a statement this designation is insufficient to protect public health. The review process for food additives offers greater protection, they said.

AquaBounty had no comment on the petition.

The FDA did not comment specifically on the petition, but confirmed that the company’s application for FDA approval for AquAdvantage salmon is under review, and that genetically engineered animals are evaluated under the new animal drug provisions of U.S. law.

AquaBounty has said in the past that it sees these genetically modified salmon as a potential solution to environmental concerns associated with salmon aquaculture, and discounted fears they might accidentally escape into the wild and affect other fish.

However, Food & Water Watch Executive Director Wenonah Hauter said the company’s own study showed that genetically engineered salmon may contain increased levels of a hormone linked to breast, colon, prostate and lung cancer.

The petitioners said a proper review would require genetically engineered salmon to go through comprehensive toxicological studies to ensure the fish are safe to consume and properly labeled.

If approved, AquAdvantage would be the first genetically altered animal for human consumption in the United States.

Genetically modified vegetables such as corn have long been on the U.S. market, and the FDA allows modified animals as pets or to help produce biologic medicines.

There is no timeline for an FDA decision. As a matter of policy, the FDA does not comment on citizen petitions.

(Reporting By Deborah Zabarenko, Environment Correspondent; Editing by Todd Eastham)

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By Genevra Pittman

NEW YORK |
Tue Feb 7, 2012 5:34pm EST

NEW YORK (Reuters Health) – About half of all elementary school students can buy potato chips, ice cream or similar snacks in vending machines and at snack bars during school, suggests a new study.

Researchers said they’d hoped that with more encouragement for districts to improve nutrition in foods offered at school and an increasing focus on childhood obesity, fewer kids would have access to unhealthy options — especially ones that they might substitute for a more balanced school lunch.

Elementary school “is really a crucial period where the preferences and behavioral habits are being developed,” said Lindsey Turner, one of the study’s authors from the University of Illinois at Chicago.

“If kids are early on in that environment where that junk food is around, then it potentially becomes a habit that’s harder to break,” she told Reuters Health, adding that the new finding was “disappointing.”

The study was based on a survey of school teachers and food service workers about snack options, so the researchers couldn’t tell how many children actually bought the sugary and salty snacks, or whether kids who went to schools with vending machines and snack bars were more likely to be overweight than those that didn’t.

The survey results, from close to 4,000 schools queried between 2006 and 2010, showed that about half of all public and private elementary schools had vending machines, snack bars or similar options where food was sold during lunchtime. Almost all of them sold sweet or salty snacks, while about two-thirds also had healthier fruit and vegetable options.

Kids generally had more access to junk food in suburban schools and schools in the southern United States, according to findings published Monday in the Archives of Pediatrics & Adolescent Medicine.

Dr. Y. Claire Wang, who studies childhood nutrition and obesity at the Columbia University Mailman School of Public Health in New York, said that some previous studies have suggested that school snacks have become more nutritious in recent years.

But the new findings suggest that “there is a lot to be done still,” Wang told Reuters Health.

Wang was not involved in the new study, though both she and the research are supported by the Robert Wood Johnson Foundation.

Turner said that there’s currently a “huge window of opportunity,” as the United States Department of Agriculture is in the process of deciding on regulations for snacks available in schools, which could limit the amount of fat and sugar in those products.

She said that in the meantime, parents should know what’s being sold at their kids’ schools, and when.

Wang added that parents can provide a good example of healthy eating and exercise for their young kids, and can also petition schools to offer better snack options.

“The community (and) the parents have to take a lot of responsibility as well,” she concluded.

SOURCE: bit.ly/xjdzV1 Archives of Pediatrics & Adolescent Medicine, online February 6, 2012.

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By Genevra Pittman

NEW YORK |
Tue Feb 7, 2012 4:40pm EST

NEW YORK (Reuters Health) – A new study further eases fears that the rotavirus vaccine might increase the risk of blocked bowels in infants — a concern that led to an earlier version of the vaccine being pulled from the market in the United States.

In the report on close to 800,000 doses of the vaccine, which protects against severe diarrhea, vaccinated babies were no more likely to end up in the hospital or emergency room with so-called intussusception — when one part of the intestine slides inside another like a telescope.

The findings jibe with a recent report that found that hospitalizations for the intestinal problem didn’t significantly increase in babies after rotavirus vaccination became routine in 2007 (see Reuters Health story of January 5, 2012).

“We can’t rule out that a low-level risk could exist,” said researcher Irene Shui, from Harvard Medical School in Boston.

But, “our results do add to the message that even if there was a low-level risk of intussusception, the benefits of the vaccine far outweigh those risks,” Shui told Reuters Health.

The initial version of the rotavirus vaccine was introduced in the U.S. in 1998 and pulled the next year following increased reports of intussusception. The thinking was that the vaccine, a weakened dose of the live virus, might occasionally stimulate an immune response in the intestinal tract and change its shape.

Two newer vaccines, taken orally, didn’t increase those risks during pre-approval testing — but since have been linked to slightly higher-than-usual reports of bowel problems in Mexican and Australian infants.

To see if that would also apply in the U.S., researchers tracked babies recently given the RotaTeq vaccine, produced by Merck, between 2006 and 2010. They compared cases of intussusception in those infants to babies who didn’t get the rotavirus vaccine during that time, and to intussusception hospitalizations in 2001 to 2005, before the vaccine was re-introduced — and found no differences.

In the first month after babies received any of the 787,000 vaccinations, there were 21 cases of intussusception, compared to the 20.9 that would have been expected with no vaccine, based on past records. And after 310,000 first doses of the vaccine, there were seven cases in the next month, compared to the predicted 5.7 cases.

Both of those small differences could have been due to chance, Shui’s team reported in the Journal of the American Medical Association on Tuesday.

There were similar numbers of bowel problems in babies who did and didn’t get the rotavirus vaccine in the late 2000′s — but there were so few cases in either group that it was hard to compare specific situations, such as the risk of intussusception in the first week after a first vaccine dose.

The study was funded by the Centers for Disease Control and Prevention. One of the authors reported receiving research support from Merck in the study’s conflicts of interest disclosure.

The researchers said their results can’t rule out the possibility that a slightly increased risk would show up among a bigger sample of vaccinated babies.

“I think it’s important for both parents and physicians to realize that vaccines like the rotavirus vaccine have had a tremendous public health benefit, but every treatment or vaccine has some risk,” Shui said.

She said that the rotavirus vaccine has prevented up to 50,000 diarrhea hospitalizations each year in the U.S. If there was a small risk of intussusception, similar to that shown in other countries, it would translate to 40 to 60 extra cases of the bowel problem annually.

Dr. Joseph Zickafoose, a pediatrics and communicable diseases researcher at the University of Michigan in Ann Arbor and one of the authors of the earlier study, called the findings “very encouraging” and agreed that the balance of harms and benefits strongly favors vaccination.

The new study, he told Reuters Health, “should reassure families that the rotavirus vaccine is safe and that the benefits of preventing severe illness and ending up in the hospital outweigh any risks, which we don’t seem to be finding.”

SOURCE: bit.ly/hwxtTL Journal of the American Medical Association, online February 7, 2012.

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