Smoking in pregnancy tied to lower reading scores

NEW YORK (Reuters Health) – Babies exposed to their mother’s cigarette smoke in the womb later perform more poorly on reading comprehension tests, according to a new study.

“It’s not a little difference – it’s a big difference in accuracy and comprehension at a critical time when children are being assessed, and are getting a sense of what it means to be successful,” lead author Dr. Jeffrey Gruen of Yale University told Reuters Health.

In the study, researchers found that children born to mothers who smoked more than one pack per day struggled on tests specifically designed to measure how accurately a child reads aloud and if she understands what she read.

On average, children exposed to high levels of nicotine in utero — defined as the minimum amount in one pack of cigarettes per day — scored 21 percent lower in these areas than classmates born to non-smoking mothers. The difference remained even when researchers took other factors — such as if parents read books to their children, worked in lower-paying jobs or were married — into account.

Put another way, among students who share similar backgrounds and education, a child of a smoking mother will on average be ranked seven places lower in a class of 31 in reading accuracy and comprehension ability, said co-author Jan Frijters of Brock University in Ontario, Canada.

Previous studies have found smoking during pregnancy is linked to lower IQ scores and academic achievement, and more behavioral disorders. The authors found no reports so far that zeroed in on specific reading tasks like accuracy and comprehension in a large population.

The team, which published their results in The Journal of Pediatrics, pulled data from more than 5,000 children involved in the Avon Longitudinal Study of Parents and Children (ALSPC) study that began in the early 1990s in the UK. Only data from children with IQ scores of 76 and higher were used. An IQ score of 70 and below can be the sign of a mental disability.

UK researchers collected questionnaires from mothers before and after giving birth. This helps make the self-reported data more trustworthy, explained Sam Oh of the University of California, San Francisco, who wasn’t involved with the work. If mothers knew their child’s reading scores beforehand, they might subconsciously report more or less smoking.

“To me, this study suggests that the effects attributed to in utero smoking can in fact be attributed to the intrauterine environment, and not due to environmental differences that the children grow up in,” Oh told Reuters Health by email.

Large observational studies like this one call attention to patterns, but do not prove a direct cause-effect relationship between cigarette smoking and low reading scores.

Despite public health initiatives to discourage smoking, as many as one in six pregnant American women still light up, according to national surveys by the Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services.

“That is a lot of children,” Dr. Tomáš Paus of the University of Toronto told Reuters Health.

Paus added that the study tied the effects of low test scores to nicotine in cigarettes, which also produce other harmful chemicals and carbon dioxide. Either way, smoking while pregnant seems to put a baby at risk for negative health outcomes.

“We should not be happy with those rates. Smoking during pregnancy is preventable,” Paus said.

SOURCE: http://bit.ly/W7v2kM The Journal of Pediatrics, online November 5, 2012.

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Why Mommy Can’t Get Ahead

In political terms, it was a good year for American women. Female voters were a decisive factor in the presidential race, with 55 percent casting ballots for President Barack Obama, vs. 44 percent for Mitt Romney; the only year the spread was higher was in 1996, according to the Center for American Women and Politics at Rutgers University. A record number of female candidates ran for national office—18 for the Senate, up from the 2010 high of 14, and 166 for the House of Representatives, vs. 141 in 2004—which means the 113th Congress will have at least 98 female members, the most ever, including a record 20 Senators. “We hope that this 20 percent will make a difference in the macaroni-and-cheese issues that we want to focus on, along with the macro issues,” Senator Barbara Mikulski (D-Md.) told the Wall Street Journal on Nov. 8.

Mikulski and her colleagues have reason to celebrate the female power surge, but those hard-won electoral victories should be kept in perspective. While the sweep of women into office is encouraging to anyone who believes that Washington is badly in need of fresh ideas, not to mention a political class that better reflects the population at large, there’s one area where it’s unlikely to make a difference, at least in the near future: the workplace.

For many working women, the most revealing moment of this political season came during the second presidential debate, on Oct. 16. A 24-year-old teacher named Katherine Fenton asked both candidates what they planned to do about the reality that women still earn, on average, 23 percent less than men. Obama cited the Lilly Ledbetter Fair Pay Act, the first major piece of legislation he signed after taking office, which makes it easier for employees to sue employers for discrimination based on disparities in pay. Romney seemed dumbfounded, rambling about how as governor of Massachusetts he’d searched out qualified females to hire, flipping through “binders full of women” like a bachelor shopping for a mail-order bride.

The ridicule Romney earned for that exchange obscured the fact that neither man attempted to address how to close the pay gap now. This failure was stunning considering that women comprise 47 percent of the workforce and earn more college degrees than men. The number of dual-income households in which women are the primary breadwinner reached 29 percent in 2009, reflecting a radical upending of the traditional model. Women are an increasingly vital part of the workforce—yet, despite talk of the downfall of men, they still don’t come close to economic parity. Obama’s answer in particular highlights the widely held belief that there’s only so much Washington can do.

Illustration by Mark Todd

A mini-industry has sprung up around the question of why women don’t go as far, and earn less, than their male counterparts. But the answer is actually straightforward. After accounting for experience and education, as well as occupation—male-dominated fields tend to be higher-paying than female-dominant ones—the pay gap falls from 23 percent to about 9 percent, according to Cornell University labor economists Francine Blau and Lawrence Kahn. Outright discrimination plays a part, but a larger proportion of the disparity can be attributed to the hit women take for absorbing most of the child-care duties that crop up at home, a burden one might call the “caregiver tax.”

Illustration by Mark Todd

The answer to Fenton’s question is thus only partly about discrimination (as Obama suggested) and has almost nothing to do with the failure of managers to identify qualified women (in Romney’s formulation). Instead, says Claudia Goldin, an economist at Harvard University who’s researched gender and the labor market, “The problem she’s concerned about is almost entirely rooted in the fact that women take care of children a lot more than men.” (Women also shoulder more of the burden of caring for siblings, grandparents, and in-laws.) There are “differences in the ways in which men and women respond to competition, bargain, search for jobs, and so on,” says Goldin. Compared with the caregiver burden, however, “everything that I have seen and have done using the best data on the planet indicates that everything else is second order.”

These issues were barely mentioned during the presidential campaign. The U.S. remains one of the only industrialized nations not to guarantee mothers (or fathers, for that matter) some paid time off after the birth of a child. The Family and Medical Leave Act of 1993 provides for 12 weeks of unpaid leave for pregnancy or other reasons, but it falls short on several fronts: It’s too brief (Germany, Canada, and many other countries offer up to 12 months of subsidized leave), and it excludes vast segments of the workforce employed by small companies that don’t qualify or who couldn’t afford to take it anyway.

Illustration by Mark Todd

When it comes to taking care of the kid after it’s born, the situation is no better: Most working parents must navigate an expensive landscape of day-care centers and nannies with few clues about the quality of what they’re paying for. “The investment that the United States makes in early childhood care and education pales by comparison to the investments being made by other countries,” writes Jane Waldfogel in “International Policies Toward Parental Leave and Child Care,” published by the Future of Children, a collaboration between the Brookings Institution and Princeton University.

More family-friendly public policies in these two areas would make a difference, but they only go so far. Reaching true economic and professional equality between the sexes will require a re-imagining of workplace culture—which continues to penalize women who need flexible schedules, even as it actively disincentivizes men from assuming more duties at home, lest they step off the career track. The attention generated by Anne-Marie Slaughter’s Atlantic article, “Why Women Still Can’t Have It All,” and Yahoo!/ticker] Chief Executive Officer Marissa Mayer’s two-week maternity leave, reflect the broad desire for a change. “Employers have an increasing incentive to address work-family issues,” Blau says. “This is disproportionately important to women, but it’s also important to men.”

Much like the Republican Party, companies are facing changing demographics, and the sooner they embrace them, the stronger they’ll be. “I call this the business case for gender diversity,” says Iris Bohnet, academic dean and professor of public policy at the Harvard Kennedy School. Bohnet mentions several studies, including one by the Credit Suisse Research Institute, showing that companies with more women on their boards perform better. Increasingly, women are better-equipped to perform essential jobs, so businesses need to adjust to their needs. “In many ways we have a mid-20th century workplace for a mid-21st century workforce,” Goldin says.

In some cases, change is forced upon a profession from the inside. Pediatric medicine, for instance, used to be a primarily male specialization, yet women now comprise 57 percent of pediatricians and 70 percent of pediatric residents, according to the American Academy of Pediatrics. And, Goldin points out, 35 percent to 40 percent of pediatricians work fewer than 35 hours per week, a drastic shift. “It happened because as a lot more women became pediatricians, a lot more shopped around for more predictable hours and more ability to have fewer and more flexible hours,” Goldin says. Pharmacy and veterinary medicine have shown similar trends.

At the other end of the earnings spectrum are nursing home workers, who tend to be paid by the hour. If one of those workers needs to miss an hour of work one day, she—“it’s almost always a she,” Goldin says—is often told not to bother coming in at all, losing a whole day’s pay. A group at Harvard is experimenting with ways to manage employee schedules that would allow greater flexibility. Instead of a fixed group of 25 workers, for example, a facility could hire 28, with more fluid scheduling. The arrangement could benefit the employees and give the nursing home a more stable workforce.

Katherine Fenton may not have received a satisfying answer to her question, but that doesn’t mean answers are out of reach. Fixing the pay gap will demand more progressive public policies as well as businesses to modernize their cultures to accommodate both halves of the workforce. This isn’t about being generous; it’s self-interest. We shouldn’t need a president to tell us that.

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France urges Mali to step up talks with rebels

PARIS (AP) — France‘s president called Thursday for stepped-up talks between Mali’s government and any leaders from its breakaway north “who reject terrorism,” even as African nations geared up for a possible military operation against Islamic extremists there.

President Francois Hollande‘s comments suggested a growing openness to dialogue with the extremists, but he remained committed to supporting the military planning effort.

Northern Mali fell to Islamic extremists in April, after coup leaders toppled the government in Bamako, Mali‘s capital. Fearing that northern Mali could become the latest hotbed of terrorism, France has been a driving force in international efforts to bolster Mali’s army to drive the Islamists from power.

Hollande spoke with interim Mali President Dioncounda Traore by phone on Thursday, partly to detail European efforts to help strengthen Mali’s army.

In recent days, representatives from the most moderate of three al-Qaida-linked groups that control northern Mali have been meeting with Burkina Faso‘s president, appointed as a mediator.

“France reiterates its wish that political dialogue will intensify between Malian authorities and representatives of northern populations who reject terrorism,” Hollande’s office said in a statement. “The acceleration of this dialogue must accompany the progress in African military-planning efforts.”

Earlier this week, the African Union approved a plan that calls for 3,300 African troops to be deployed in order to win back Mali’s north. European countries including France and Germany have expressed a willingness to provide military trainers and logistics support, but have stopped short of committing combat troops.

France, like many European countries, fears that the arid, northern Sahel region of Mali could become a breeding ground for terrorism, where al-Qaida and its allies could plot hostage-takings and attacks in Europe or beyond.

France has millions of people whose families hail from former French colonies in north and west Africa. Authorities have long been concerned that French-born militants could travel abroad for terrorism training and return home later to possibly carry out attacks.

French authorities are already investigating two French citizens who were arrested in Mali and neighboring Niger and are suspected of seeking to join up with the al-Qaida-linked extremists, a judicial official told The Associated Press.

Ibrahim Ouattara, a 24-year-old native of the northern Paris suburb of Aubervilliers who has dual French and Malian nationality, was arrested inside Mali this month and remains in custody there, the official said.

Separately, a 27-year-old Frenchman was arrested in August in Niger and has since been handed over to authorities in France, the official said, speaking on condition of anonymity because she was not authorized to discuss terrorism cases publicly.

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ABC Adapting Disney Theme-Park Ride for “Big Thunder Mountain” Pilot

LOS ANGELES (TheWrap.com) – ABC found ratings success by adapting Disney‘s finest fairy tales into the one-hour drama series “Once Upon a Time,” so it’s not surprising that the network has turned to a theme-park ride from its parent company for inspiration as well.

Popular roller coaster Big Thunder Mountain Railroad is being adapted for a television pilot by the Disney-owned network, an individual with knowledge of the situation told TheWrap.

Chris Morgan (“Wanted,” “Fast Five”) will co-write the story with “Ice Age: Continental Drift’s” Jason Fuchs, who will write the teleplay. ABC has ordered a script from ABC Studios, the individual said.

No word on what the show will have in common with the ride, but if it sticks with the theme presented to visitors at parks in California, Florida, Paris and Tokyo, it should have something to do with a mining town being destroyed by a natural disaster after settlers desecrate sacred Native American land.

Two other film projects have been developed based on Disney rides, “Pirates of the Caribbean” and 2003′s not-equally-successful “The Haunted Mansion.”

Morgan is represented by ICM Partners and McKuin Frankel, while Fuchs is repped by WME and Brookside and Bloom Hergott.

The Hollywood Reporter first broke the news on “Big Thunder Mountain.”

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Kids with Down syndrome twice as likely to be heavy

NEW YORK (Reuters Health) – More than one in four children with Down syndrome in The Netherlands is overweight, a rate double that of Dutch youth without the developmental disability, according to a new study.

“We were alarmed by the high prevalence of overweight in children with Down syndrome,” said Dr. Helma van Gameren-Oosterom, the lead author of the study from the Netherlands Organization for Applied Scientific Research in Leiden.

“Of course we knew that the prevalence of overweight is rising; for Dutch standards a twofold level, however, was not expected.”

Previous studies have suggested children with Down syndrome are especially prone to being heavy. But researchers still aren’t sure why that is, according to Dr. Sheela Magge, an endocrinologist at Children’s Hospital of Philadelphia, who was not part of the new study.

Theories have ranged from physiological differences in metabolism or the way the body suppresses appetite to behavioral differences, such as in how much exercise children get, she said, but no studies have been able to pin down the definitive cause.

About 6,000 babies – or one in every 691 – are born with Down syndrome each year in the U.S., according to the Centers for Disease Control and Prevention.

For the latest study, the researchers compared growth patterns among 659 children with Down syndrome and no other health problems to general data on youth in The Netherlands.

By calculating kids’ weight relative to their height – a unit called body mass index (BMI) – the research team determined which children were overweight and which were obese. The BMI cutoffs for obesity and overweight are different for each age in children.

Magge said they’re not a perfect measure for children with Down syndrome because their body proportions are different than those of other children, but it’s the best available yardstick for now.

Gameren-Oosterom and her colleagues found 25.5 percent of boys with Down syndrome were overweight and 4.2 percent were obese.

Among girls with the condition, 32 percent were overweight and 5.1 percent obese, they report in the medical journal Pediatrics.

In comparison, children in the rest of the Dutch population had much lower rates: for boys, 12.3 percent were overweight and 1.7 percent obese; for girls, 14.7 percent were overweight and 2.2 percent were obese.

Magge said researchers have also observed higher rates of overweight among children with Down syndrome in the U.S.

Gameren-Oosterom wrote in an email to Reuters Health that she and her colleagues suspect lifestyle has something to do with that pattern. Because it’s harder for young people with Down syndrome to develop their motor skills, they may be less active.

Low muscle tone and poor coordination often accompany the disability as well, Magge told Reuters Health.

Her concern with so many kids being overweight is that as people with Down syndrome are living longer, “we may start seeing more complications and comorbidities such as diabetes, cardiovascular disease (and) hypertension, all those things that we worry about in all of our obese adolescents.”

Gameren-Oosterom said it’s difficult to develop a prevention or treatment strategy to target overweight and obesity in children with Down syndrome, given that the causes are unknown.

But like all youth, she added, those children will benefit from a healthy diet and sufficient exercise.

Magge said people with Down syndrome tend to prefer keeping strict routines, which could be something parents can take advantage of to help instill healthy habits.

“In adults it might be that if they get into a routine of eating healthy it’s more likely to stick,” she said.

SOURCE: http://bit.ly/SnWv05 Pediatrics, online November 12, 2012.

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Wal-Mart 3Q profit up but sees sales shortfall

NEW YORK (AP) — Wal-Mart Stores Inc. reported a 9 percent increase in net income for the third quarter, but revenue for the world’s largest retailer fell below Wall Street forecasts as its low-income shoppers continue to grapple with an uncertain economy.

The discounter issued a fourth-quarter profit outlook that fell short of Wall Street expectations, and the company’s stock price slid more than 3 percent.

Wal-Mart is considered an economic bellwether because the retailer accounts for nearly 10 percent of nonautomotive retail spending in the U.S. The company’s latest results show that many low-income Americans — it’s estimated that the typical Wal-Mart customer has an average household income of between $ 30,000 and $ 60,000, rents their homes and doesn’t own stock — continue to struggle even as the housing and stock markets are improving.

The disappointing revenue comes as Wal-Mart, like other retailers, is preparing for the busy winter holiday shopping season in the U.S. next week. The period, which runs roughly from November throughout December, is a time when stores can make up to 40 percent of their annual revenue. Wal-Mart has said that it plans to offer deeper discounts and a broader assortment of merchandise during this year’s season to draw in shoppers.

“Macroeconomic conditions continue to pressure our customers,” said Charles Holley, Wal-Mart’s chief financial officer. “The holiday season is predicted to be very competitive but we are well prepared to deliver on the value and low prices our customers expect.”

The disappointing revenue results come a year after Wal-Mart’s U.S. namesake business turned a corner by reemphasizing low prices and restocking stores with thousands of basic items that it had gotten rid of in an overzealous bid to reduce clutter.

During the third quarter of last year, the division reversed nine straight quarters of declines in revenue at stores opened at least a year, which is considered a key measure of a retailer’s health. The U.S. namesake business has recorded five consecutive quarters of gains since the division rebounded, including a 1.5 percent increase in the third quarter.

But the third-quarter gain is just shy of the 1.8 percent increase analysts polled by Thomson Reuters were expecting. It’s also a slowdown in growth from the 2.2 percent gain the business posted in the second quarter and the 2.6 percent increase it had in the first quarter.

Analysts say that Wal-Mart’s previous results had benefited from the increase in prices shoppers were paying for groceries due to inflation for some items, a trend that is now subsiding. They also say that Wal-Mart is facing tougher revenue comparisons from a year ago when its business first began to rebound.

Ken Perkins, president of Retail Metrics, a research company, said Wal-Mart’s revenue is headed in the right direction. But he cautioned that the company will need to continue to keep prices low in order to compete with rivals that have stepped up discounting.

“Overall, it’s a relatively good report,” he said. “But it shows that its consumer is still struggling.”

In the third quarter, Bentonville, Ark.-based Wal-Mart earned $ 3.63 billion, or $ 1.08 per share, in the quarter ended Oct. 31. That compares with $ 3.33 billion, or 96 cents per share, in the year-ago period.

Net revenue, excluding Sam’s Club membership fees, rose 3.4 percent to $ 113.2 million. Excluding the currency impact, net revenue would have been $ 114.9 million. Analysts were expecting $ 1.07 per share on net revenue of $ 114 billion.

Nearly all areas, including food and clothing, registered gains. However, the company’s entertainment category, which includes gaming, suffered a decline, dragged down by price deflation. Part of the weakness is also due to the company’s layaway business, which winds up deferring sales to the fourth quarter.

For the entire U.S. business, sales at stores opened at least a year rose 1.7 percent, below the 2.1 percent Wall Street estimate. At Sam’s Club, the figure was up 2.7 percent, below the 3.8 percent increase Wall Street expected and the 4.2 percent gain it posted in the second quarter.

The company said its business members at Sam’s Clubs are being hurt by the economic downturn, and are switching to less-expensive chicken from beef. To boost sales, Sam’s Club is increasing its offering of rotisserie chicken, and has reduced prices in several varieties of apples and beauty products.

“Our business members continue to experience economic pressure and uncertainty,” said Rosalind Brewer, president of Sam’s Clubs.

For the full year, Wal-Mart now said it expects earnings per share to be between $ 4.88 per share and $ 4.93 per share. It originally expected earnings per share of $ 4.83 to $ 4.93. For the fourth quarter, it forecasts earnings per share to be $ 1.53 per share and $ 1.58 per share. Analysts had expected $ 1.59 per share.

Separately, in a filing with the U.S. Securities and Exchange Commission, Wal-Mart said Thursday that it was looking into potential violations related to the Foreign Corrupt Practices Act in Brazil, China and India. This comes after Wal-Mart initially began investigating its Mexico operations following report that surfaced in April that the retailer allegedly failed to notify law enforcement when company officials authorized millions of dollars in bribes in Mexico to speed building permits and gain other favors. The company continues to work with government officials in the U.S. and Mexico on that investigation.

On Thursday, Wal-Mart’s stock fell $ 2.61 to close at $ 68.70. Over the past 52 weeks, Wal-Mart stock has been trading between $ 56.26 and $ 77.60.

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Egypt recalls envoy to Israel after Gaza strike

CAIRO (AP) — Egypt has recalled its ambassador to Israel after an Israeli airstrike killed the military commander of Gaza‘s ruling Hamas.

In a statement read on state TV late Wednesday, spokesman Yasser Ali said that President Mohammed Morsi recalled the ambassador and asked the Arab League‘s Secretary General to convene an emergency ministerial meeting in the wake of the Gaza violence.

Morsi also called for an immediate cease fire between Israel and Hamas, an offshoot of Morsi’s Muslim Brotherhood. Israel says it struck in response to rocket attacks from Gaza.

Hours earlier, Morsi’s Muslim Brotherhood group denounced the Israeli airstrike as a “crime that requires a quick Arab and international response to stem these massacres.”

Relations between Israel and Egypt have deteriorated since longtime President Hosni Mubarak was ousted last year.

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Judge tosses anti-paparazzi counts in Bieber case

LOS ANGELES (AP) — A law aimed at combating reckless driving by paparazzi is overly broad and should not be used against the first photographer charged under its provisions, a judge ruled Wednesday.

Superior Court Judge Thomas Rubinson dismissed counts filed under the law against Paul Raef, who was charged in July with being involved in a high-speed pursuit of Justin Bieber.

The judge cited numerous problems with the 2010 statute, saying it was aimed at newsgathering activities protected by the First Amendment, and lawmakers should have simply increased the penalties for reckless driving rather than targeting celebrity photographers.

Attorneys for Raef argued the law was unconstitutional and wasn’t meant to protect the public.

“It’s about protecting celebrities,” attorney Brad Kasierman said. “This discrimination sets a dangerous precedent.”

Prosecutors argued that the law, which seeks to punish those who drive dangerously in pursuit of photos for commercial gain, could apply to people in other professions, not just the media.

“The focus is not the photo. The focus is on the driving,” Assistant City Attorney Ann Rosenthal argued.

While the media is granted freedom under the First Amendment, its latitude to gather news is not unlimited, Rosenthal argued.

“This activity has been found to be particularly dangerous,” she said of chases involving paparazzi.

Raef still faces traditional reckless driving counts and has not yet entered a plea,

Prosecutors claim he chased Bieber at more than 80 mph and forced other motorists to avoid collisions while trying to get shots of the teen heartthrob on a Los Angeles freeway.

The chase prompted several 911 calls from scared motorists and led to Bieber being pulled over.

Rubinson cited hypothetical examples in which wedding photographers or even those rushing to do a portrait shoot with a celebrity could face additional penalties if charged under the new statute.

Rosenthal also argued that the judge should look at factors specific to Raef’s case, not hypothetical scenarios.

Kaiserman said the ruling only applies to Raef’s case but could lead to the law being struck down if prosecutors appeal.

___

Anthony McCartney can be reached at http://twitter.com/mccartneyAP

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U.S. Congress takes aim at FDA over meningitis outbreak

WASHINGTON/NEW YORK (Reuters) – Members of a congressional committee investigating the deadly U.S. meningitis outbreak accused the Food and Drug Administration on Wednesday of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy.

Tainted steroids from the pharmacy, New England Compounding Center (NECC), have so far killed 32 people and sickened 461 in 19 states, according to updated figures from the U.S. Centers for Disease Control and Prevention. Those numbers are expected to rise with as many as 14,000 people having been exposed to the drugs injected to ease back pain.

“After a tragedy like this, the first question we all ask is: could this have been prevented? After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer here appears to be yes,” Cliff Stearns, Republican chairman of the oversight and investigations panel, said at the hearing of the House Energy and Commerce Committee.

The panel aims to learn why regulators took no action against the Framingham, Massachusetts-based compounding pharmacy that manufactured the tainted drug – despite repeated problems dating back to 1999, including adverse patient reactions to a sterile steroid treatment from as early as 2002.

In a highly contentious hearing that lasted four hours, committee members repeatedly accused FDA Commissioner Margaret Hamburg of failing to answer questions about FDA authority and a lack of action against NECC. Hamburg in turn insisted that the FDA lacks clear authority to regulate compounding pharmacies due to conflicting court rulings and other regulatory ambiguities.

She said new laws must be passed that give the FDA clear authority to regulate compounding pharmacies as it does large drug manufacturers.

“This isn’t, sadly, an isolated incident. This is the worst and most tragic. It should be the last wakeup call for us,” Hamburg said of the deadly meningitis outbreak.

“We really need a strong, clear and appropriate legislation. We cannot have a crazy quilt where different parts of the country are subject to different legal frameworks,” she told the committee.

UNREGULATED COMPOUNDING

Drug compounding is a little-known practice in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients with a doctor’s prescription. It is overseen primarily by state authorities that are often ill-equipped for the job.

But in some cases, as with NECC, compounding has evolved to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.

FDA and Massachusetts officials inspected the NECC more than 10 years ago after patients were hospitalized with meningitis-like symptoms and identified contamination in the same drug at issue in the current outbreak.

“Ten years later, we are in the midst of an unthinkable, worst-case scenario – the body count is growing by the day – and hundreds, hundreds – have fallen ill. Inexcusable,” said Fred Upton, Republican chairman of the House Energy and Commerce Committee.

Upton criticized FDA for not providing all the documents related to NECC or a clear timeline of events. He said his committee requested both more than a month ago.

However, U.S. Representative Henry Waxman of California, the committee’s ranking Democrat, defended the FDA and turned his ire toward NECC.

“Let’s not lose sight of the wrongdoers as we go around blaming regulators,” Waxman said.

He noted that the FDA knew 10 years ago that there could be a meningitis outbreak due to practices at NECC “and it wasn’t corrected by the company.”

He said the agency met with “stubborn refusals and a challenge to FDA’s authority” from NECC officials.

Waxman called for bipartisan legislation that gives FDA clear and effective authority to prevent compounders from becoming dangerous drug manufacturers like NECC.

HAMBURG IN HOT SEAT

But Republican committee members repeatedly, and sometimes angrily, challenged Hamburg’s contention that FDA lacked the authority to oversee compounders that had grown into defacto manufacturers.

“We’re just not buying it Ms. Hamburg,” said Representative Michael Burgess of Texas, an obstetrician by profession.

“Go look in the eyes of the victims and try to tell them that,” said Republican Tim Murphy of Pennsylvania.

Nebraska Republican Lee Terry was extremely combative with Hamburg, repeatedly asking for specific statutes that prevented FDA oversight of compounders and cutting off her attempts to respond. Terry went as far as accusing the commissioner of deliberately providing written testimony in the middle of the night so committee members had little time to review it.

“I know that you’re frustrated with my answers and I’m sorry. I can’t just give ‘yes or no’ answers. This is complex,” Hamburg told Murphy at one point.

Murphy shot back that what victims were going through was complex. “Leadership is easy if you’re willing to accept it. You are not.”

Florida Democrat Kathy Castor rose to Hamburg’s defense in describing current laws on regulating compounders as varying from region to region, creating conflicting enforcement issues.

“There is ambiguity. There is great ambiguity,” she said.

Waxman also attempted to rescue Hamburg, accusing Republican counterparts of playing politics. “I have a feeling, Dr. Hamburg, that you’re being picked on by Republicans because you’re with the Obama administration,” he said.

He pointed out that past FDA failures being referred to took place under a different commissioner during the Bush administration.

The panel also heard testimony from the widow of one of the victims, as well as Massachusetts Department of Public Health interim Commissioner Dr. Lauren Smith, to whom congress members were respectful and complimentary, and NECC co-owner Barry Cadden, who refused to answer any questions from the committee.

Cadden, a short, middle-aged man flanked by two attorneys, appeared before the committee with spiky close-cropped hair and wearing a dark gray business suit. He repeatedly cited his right to not incriminate himself under the fifth amendment of the U.S. Constitution when asked to explain breakdowns in sanitary conditions at NECC that led to the meningitis outbreak.

The Massachusetts Board of Registration in Pharmacy, which does have oversight of NECC, failed to carry out sanctions against the company despite repeated problems that culminated in this year’s outbreak.

Several lawmakers questioned Smith about relations between NECC and the Massachusetts pharmacy board, some saying reports of close ties among individuals could have encouraged state regulators to favor the interests of pharmacies over patients.

Waxman noted that weak sanctions to which NECC previously agreed occurred when Mitt Romney was governor of Massachusetts.

The committee heard emotional testimony from the 78-year-old widow of a Kentucky judge who was among the first to die in the meningitis outbreak.

“It was such a useless thing that happened to my husband,” Joyce Lovelace said, testifying from a wheelchair.

“I can’t begin to tell you what I have lost,” she said, her voice breaking with emotion. “I’ve come here begging you to do something about it.”

Democrat Edward Markey, whose congressional district includes the town where NECC is located, said Congress would take action.

“I commit to you and all the victims that we will not stop until this industry is safe,” he said.

(Additional reporting by Bill Berkrot in New York; Editing by Dan Grebler, Andrew Hay and Maureen Bavdek)

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Bank predicts protracted recovery

14 November 2012 Last updated at 12:35 ET

Bank of England cuts UK growth forecast for 2013

The Bank of England has cut its growth forecast for next year to about 1% from nearer 2%, and said recovery will be “slow and protracted”.

It now thinks that the economy will not get back to pre-crisis levels until 2015, two years later than it previously predicted.

The Bank also believes inflation will remain higher for longer.

Governor Sir Mervyn King also welcomed the latest jobs figures which showed a continued fall in unemployment.

He was presenting the Bank’s quarterly Inflation Report, which forecast that inflation would not now fall towards the government’s 2% target until mid-2013, rather than in the first half of next year as previously thought.

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This is going to be a long and challenging recovery from a very substantial crisis”

End Quote David Gauke Treasury Minister

The report said the UK could be stuck in a “low-growth” environment, with economic problems in the eurozone and the rest of world continuing to have an impact domestically.

As the BBC’s economics editor Stephanie Flanders put it: “The Bank hasn’t just lowered its growth forecasts for the next year or so – it has more or less given up hope of being pleasantly surprised.”

Sir Mervyn warned that growth from quarter to quarter would continue to fluctuate. In the April-June quarter growth was depressed by one-off factors such as the unseasonably bad weather and had given a misleadingly weak picture of the economy.

Similarly, growth in the July-September period was boosted by one-off factors including ticket revenue from the Olympics and Paralympics and gave “an overly optimistic impression of the underlying trend,” he said, adding that the data was not necessarily “a reliable guide to the future”.

He said: “Continuing the recent zig-zag pattern, output growth is likely to fall back sharply in Q4 [between October and December] as the boost from the Olympics in the summer is reversed. Indeed, output may shrink a little this quarter,” he said.

The Bank has previously predicted that inflation might fall towards the government’s 2% target in the first half of next year.

But it now expects inflation to stay higher for longer. “We face the rather unappealing combination of a subdued recovery, with inflation remaining above target for a while,” Sir Mervyn said.

“The road to recovery will be long and winding, but there are good reasons to suggest we are travelling in the right direction,” he said.

‘Long process’

Treasury minister David Gauke said he recognised that these were tough times, but insisted that the economy was “moving in the right direction”.

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What is new is that the Bank now thinks that the UK economy will not get back to where it was at the start of 2008 until well into 2015”

End Quote

Asked on BBC Radio 4′s The World At One if he agreed with Sir Mervyn’s warning about a potential sharp fall in output, Mr Gauke said: “The independent Office for Budget Responsibility forecasts growth in the economy in the autumn statement in three weeks’ time. I’m not going to pre-judge that.

“Clearly, there are international pressures on our economy that mean that this is going to be a long and challenging recovery from a very substantial crisis. That is what we are going through at the moment. I think the British people understand that this is going to be a long process,” he said.

However, shadow chancellor Ed Balls said: “This sobering report shows why David Cameron and George Osborne’s deeply complacent approach to the economy is so misplaced.

“Their failing policies have seen two years of almost no growth and the Bank of England is now forecasting lower growth and higher inflation than just a few months ago.

“Britain needs a plan to create the jobs and growth we need to get deficits down, including using funds from the 4G auction to build 100,000 affordable homes and create hundreds of thousands of jobs,” Mr Balls said.

The Bank’s report came on the day that the Office for National Statistics said that the UK unemployment rate fell to 7.8% in the July-September quarter, down from 8% in the previous three months.

The 49,000 fall in number of jobless, to 2.51 million, was almost entirely due to a fall in youth unemployment, the ONS said. It means that the jobless total is now 110,000 lower than for the July-September quarter last year.

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However, the claimant count went up in September, leading some economists to suggest that the recent resilience of the jobs market was beginning to weaken. And the number of people unemployed for longer than a year also rose.

Sir Mervyn told the news conference: “I don’t think one would say that the data released this morning were weak.

“This is still a pretty strong labour market and, of course, it is not easy to reconcile that with the picture of underlying growth being still so weak,” he said.

Sir Mervyn also told a press conference that he had not “lost faith” in quantitative easing as a way to stimulate economic growth.

The Bank has kept the amount it injects into the economy by buying up government bonds at £375bn since July this year.

Some have questioned its effectiveness, but the Bank said it had not ruled out further asset purchases to try to stimulate growth.

He said that with the global economy still struggling, “there are limits to the ability of domestic policy to stimulate private sector demand as the economy adjusts to a new equilibrium”.

“But the [Monetary Policy] Committee has not lost faith in asset purchases as a policy instrument, nor has it concluded that there will be no more purchases.”

BBC News – Business

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