Saturday, September 28, 2013

Daimler aims to launch self-driving car by 2020

By Irene Preisinger

MUNICH | Sun Sep 8, 2013 11:02am EDT

MUNICH (Reuters) - Germany's Daimler AG plans to start selling a self-driving car by 2020 as part of its campaign to regain the top spot among premium carmakers, its development chief said.

Carmakers and suppliers across the world are working on ways to make driving safer and more comfortable through automation, and the race is on to bring the technology to the mass market.

"We want to be the first to launch autonomous functions in production vehicles. You can be sure: we will accomplish that in this decade," Daimler head of development Thomas Weber said.

Daimler, battling to regain the top stop in the luxury car market from German rival BMW, is focusing on so-called highly automated driving, in which cars master situations such as cruising the motorway or maneuvering through traffic jams while the driver relaxes.

The car would recognize difficult situations such as dealing with traffic lights or urban driving among pedestrians and cyclists, and hand control back to the human behind the wheel.

Daimler, the maker of Mercedes-Benz and Smart cars, is not alone in its ambitions. Japan's Nissan, for example, has also announced plans to launch a car completely guided by computers this decade.

Testing is already under way in many countries. U.S. internet search and advertising group Google has fitted out several cars with radar-like equipment that lets them navigate roads in California and Nevada.

The technology will feature at this week's Frankfurt car show, the world's biggest, although experts say the move from dream to reality will likely take 10 to 15 years.

German auto supplier Continental aims to enable cars to drive themselves at speeds of up to 30 km per hour (18 miles per hour) by 2016, and at up to 60 km/h by 2020.

Google is reportedly discussing an alliance with Continental on self-driving cars that could be announced as soon as this week.

OBSTACLES

Daimler's Weber said it was hard to forecast exactly when drivers would turn into passengers in their own cars. "Autonomous driving will not come overnight, but will be realized in stages," he said.

One obstacle to overcome is making it legal for cars to steer themselves. European Union laws currently call for drivers to be in control of cars at all times, so test vehicles at Daimler and BMW need special approval in Germany.

There's also the challenge of convincing drivers of the technology, although Georgeric Legros, a Paris-based management consultant with AlixPartners, believes attitudes are changing.

"The slightly macho aspect of cars is gradually disappearing in favor of a more functional, safety-minded image," he said.

"People prefer to be comfortably installed in a leather seat, reading the paper or catching up on email, rather than stuck behind the wheel in a traffic jam or on a monotonous motorway."

Technology already on the market allows partly automated driving in which motorists stay in control but get a hand from the vehicle.

Daimler for instance offers traffic jam assistance, which can maintain distance to other cars in stop-go situations, in its top-line S-Class Mercedes, and BMW will roll this out in its new i3 electric car before the end of the year.

Rivals including Audi and Volvo Cars are moving in the same direction.

Daimler sees itself ahead in the race to develop robot cars because it says its technology can handle city driving as well as motorways. It uses readily available sensors rather than specially designed technologies for research vehicles.

A Mercedes test vehicle recently traveled the same 100-km stretch between the German cities of Mannheim and Pforzheim that Bertha Benz drove 125 years ago to demonstrate the practicality of the automobile.

(Additional reporting by Laurence Frost; Writing by Michael Shields; Editing by Mark Potter)


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Friday, September 27, 2013

Apple hit with U.S. injunction in e-books antitrust case

A woman holds up an iPad with the iTunes U app after a news conference introducing a digital textbook service in New York in this January 19, 2012, file photo. REUTERS/Shannon Stapleton/Files

A woman holds up an iPad with the iTunes U app after a news conference introducing a digital textbook service in New York in this January 19, 2012, file photo.

Credit: Reuters/Shannon Stapleton/Files

By Nate Raymond

NEW YORK | Fri Sep 6, 2013 6:50pm EDT

NEW YORK (Reuters) - A U.S. judge who found Apple Inc conspired to fix e-book prices imposed new restrictions on the iPad maker on Friday, limiting its agreements with publishers.

U.S. District Judge Denise Cote in New York also said she would appoint an external monitor to review Apple's antitrust compliance policies, procedures and training for two years.

The injunction was narrower than the U.S. Justice Department had sought, in line with Cote's statement last week that she wanted it "to rest as lightly as possible on how Apple runs its business."

The department had sought a broader injunction that could have affected Apple's agreements with suppliers of movies, music and TV shows.

Cote ruled on July 10 that Apple was liable for conspiring with five publishers to raise e-book prices above those established by the dominant retailer in the market, Amazon.com Inc.

The five publishers, all of which have settled with regulators, include Lagardere SCA's Hachette Book Group Inc, News Corp's HarperCollins Publishers LLC, Penguin Random House LLC, CBS Corp's Simon & Schuster Inc and Verlagsgruppe Georg von Holtzbrinck GmbH's Macmillan.

The terms of Friday's judgment will expire after five years, but Cote's order allows for extensions in one-year increments if necessary.

The Justice Department welcomed the injunction.

"Consumers will continue to benefit from lower e-book prices as a result of the department's enforcement action to restore competition in this important industry," Assistant Attorney General Bill Baer said in a statement.

Apple said it would appeal the injunction.

"Apple did not conspire to fix e-book pricing," said company spokesman Tom Neumayr. "The iBookstore gave customers more choice and injected much-needed innovation and competition into the market."

Apple's shares rose 0.6 percent to $498.22 on Friday.

It faces a separate trial on damages demanded by states that are pursuing related claims.

The case is U.S. v. Apple Inc et al, U.S. District Court, Southern District of New York, No. 12-02826.

(Reporting by Nate Raymond; Editing by Eddie Evans and Ken Wills)


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Thursday, September 26, 2013

U.S. congressional panels agree on bill to regulate drug compounding

WASHINGTON | Wed Sep 25, 2013 8:09pm EDT

WASHINGTON (Reuters) - House of Representatives and Senate committees have agreed on legislation that would give the Food and Drug Administration greater authority to regulate companies that compound sterile drugs and ship them across state lines.

The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.

The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Massachusetts.

The legislation is expect to pass smoothly and quickly through the full House and Senate.

Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.

The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC which ship sterile products across state lines. These larger organizations, to be known as "outsourcing facilities," would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.

Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.

Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement.

But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.

The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.

In the United States, dozens of states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent. The bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.

(Reporting by Toni Clarke; Editing by Stacey Joyce and Eric Beech)


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Second Danone unit probes bribery allegations in China

By Adam Jourdan

SHANGHAI | Wed Sep 25, 2013 5:11am EDT

SHANGHAI (Reuters) - Danone SA's advanced medical nutrition unit Nutricia has started an internal investigation after a Chinese newspaper published a report alleging it had bribed more than 100 doctors in Beijing to boost sales, the company said on Wednesday.

It was the third time in two weeks that a division of French food group Danone has had to respond to accusations of bribery by Chinese media, after its infant milk formula group Dumex was twice the subject of bribery allegations reported by China's state television.

China is a magnet for foreign milk powder makers, with a $12.4 billion market that is expected to double by 2017. But foreign firms are under scrutiny after recent media reports alleging corrupt sales practices in the industry. Authorities last month also fined a group of mostly foreign milk powder producers $110 million for price fixing.

Nutricia, which makes Karicare milk formula, bribed doctors at 14 hospitals in the Chinese capital with kickbacks, gifts, funded-travel and complementary show tickets between 2010 and 2013, the 21st Century Business Herald said on Wednesday, citing an unnamed whistleblower who claimed to be a student doctor.

The whistleblower had 52 documents detailing payments from Nutricia, the largest portion of which were to Beijing Aerospace General Hospital and Xuanwu Hospital Capital Medical University, according to the paper.

Nutricia had paid a sum of 300,000 yuan ($49,000) to a dozen doctors at the two hospitals over a three-year period, it said.

"We only saw the report this morning, so we've only just started an internal investigation into the matter," Zhao Qinghua, a spokeswoman for Nutricia in China, told Reuters.

"At the moment we still don't know the details... We need to wait to see the outcome of the investigation before we can make our next plans."

The two hospitals at the center of the allegations did not immediately respond to telephone queries about the report.

Corruption in China's pharmaceutical industry remains widespread, fuelled in part by low base salaries for doctors at the country's 13,500 public hospitals.

The 21st Century Business Herald said the documents also showed that sales representatives had made bribes through more unusual means, such as cleaning doctors' fish tanks and organizing strawberry picking trips for staff.

SALES THREAT?

In the milk powder sector, hospitals are an important sales and marketing channel because a recommendation from medical staff can help persuade new parents to choose a particular brand, which they often stick with, industry insiders said.

Milk powder firms typically spend close to 5 percent of their revenue "opening" medical sales channels, a separate recent report in the 21st Century Business Herald said, citing a China-based former employee at a foreign milk powder brand.

International guidelines used in China say doctors should promote breastfeeding unless there are medical reasons not to.

Recent salvos against international milk powder companies - allegations of widespread corruption, pricing probes and strong official reaction to a food scare at New Zealand dairy producer Fonterra Co-operative Group Ltd - suggest global formula makers may face a more competitive playing field, analysts said.

A statement from China's health ministry last week said it would crack down on hospital sales tactics and punish staff who accepted bribes.

This could result in a slowdown of sales and marketing activity in hospitals for infant formula and hit sales performance, said Katherine Wang, chief China life sciences advisor for law firm Ropes & Gray.

Recent investigations into bribery in the pharmaceutical sector have hit sales operations and dented revenues for Chinese and international drug firms.

"I think (the corruption probes) will definitely create a sense of threat and also probably prevent regular interaction between the healthcare services providers and sales reps of the infant formula manufacturers," said Shanghai-based Wang.

"Because of the public oversight and the government scrutiny, I suspect within the infant formula manufacturers there's going to be an enhanced wave of internal compliance control investigations and audits."

Whistleblowers have made a beeline for the 21st Century Business Herald, with the paper publishing allegations against drugmakers Eli Lilly and Co, Novartis AG and Sanofi SA. The newspaper has declined an interview request from Reuters on why whistleblowers keep speaking to it.

In Wednesday's report, it said that under the direction of the Ministry of Supervision, Beijing and other cities had set up teams to look into the recent spate of anonymous whistleblowing, and would check the authenticity of the latest allegations against Nutricia.

(Reporting by Adam Jourdan; additional reporting by Shanghai Newsroom; Editing by Alex Richardson)


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Obamacare's average monthly cost across U.S.: $328

By Caroline Humer

Wed Sep 25, 2013 1:44pm EDT

n">(Reuters) - Americans will pay an average premium of $328 monthly for a mid-tier health insurance plan when the Obamacare health exchanges open for enrollment next week, and most will qualify for government subsidies to lower that price, the federal government said on Wednesday.

The figure, based on data for approved insurance plans in 48 states, is the broadest national estimate for the cost of coverage when President Barack Obama's healthcare reform law takes full effect next year. The prices of the new plans are at the heart of a political debate over whether they will be affordable enough to attract millions of uninsured Americans when enrollment begins on October 1.

Obama, who is facing a Republican threat to eliminate funding for the law or shut down the federal government next week, said the fierce opposition stems from the fear that Americans will embrace the program.

"Essentially they're saying people will like this thing too much, and then it will be really hard to roll back," Obama said on Tuesday in a conversation about healthcare with former President Bill Clinton. "What we're saying is, just look for yourself. Take a look at it, and you will discover that this is a good deal for you."

The Obama administration is counting on signing up 7 million Americans, including 2.7 million younger and healthier consumers who are needed to offset the costs of sicker members, in the first full year of reform through the state exchanges.

A major factor in determining the price was the level of competition among insurance companies, with rates significantly higher in states with fewer players, the U.S. Department of Health and Human Services said in its report.

The new health plans are organized in five tiers with different monthly premiums and out-of-pocket costs: catastrophic coverage, bronze, silver, gold and, in some areas, platinum.

The national average cited by HHS refers to the second-cheapest among silver plans on the market - which many healthcare economists expect to be the most popular for their balance of coverage and out-of-pocket costs. On average, the least expensive plans in this group were reported in Minnesota, where it costs $192 per month, and Tennessee, $245.

At the high end of pricing are states with large rural populations, where it can be more expensive to deliver healthcare: Mississippi at $448 per month; Alaska, $474; and Wyoming, $516. Florida came in right at the national average at $328.

U.S. Senate Republican Leader Mitch McConnell said the new plan prices were still a costlier proposition for Americans, based on what they may have paid for individual plans in the past. Under the Affordable Care Act, insurance plans must cover a wider range of preventive and other medical services and cannot turn away applicants based on prior illnesses.

"Even the Administration is having a terrible time spinning this law," McConnell said in a statement. "About the best they could claim was that some premiums would be lower than projected. Note that I didn't say lower, but lower than projected."

HOW AFFORDABLE?

Debate over whether Obamacare will prove affordable for millions of uninsured Americans has intensified in the past few months, as states have announced rates. States that have supported the law said it would lead to lower prices. Others that have opposed the reform - including Georgia, Florida, and Indiana - warned of "rate shock" for consumers compared with what they could buy on the individual insurance market a year ago.

HHS said the average price was 16 percent lower than its own projections on premiums. In addition, consumers who earn up to 400 percent of the federal poverty level, or $62,040 for a couple, will qualify for subsidies that will lower the price further.

The data is mostly based on 36 states where the federal government will operate the insurance exchange. About 14 other states and the District of Columbia are running their own exchanges. Three states - Hawaii, Kentucky and Massachusetts - had not released premium information at the time of the report.

States with the lowest average premium tend to have more insurance companies offering plans, the report said. It said eight issuers on average were selling plans in the states with average premiums in the lowest 25 percent, while states with average premiums in the top 25 percent had only three insurers on average.

Pricing varies widely not only by state but by community. For instance, Florida has 67 different geographical rating areas, and their prices for the second-lowest-cost silver plan range for a 40-year-old from $239 to $352 a month.

"The take-up of the exchanges is going to vary significantly by state and by community as word gets out," said Michael Sparer, professor of health policy at Columbia University's Mailman School of Public Health.

Texas has been among the Republican-led states most fiercely opposed to Obamacare, but its monthly rates came in below the national average, HHS said. With 76 plans to choose from in Austin, a 27-year-old would pay $169 per month for the lowest-cost mid-tier one. In Dallas-Fort Worth, that monthly premium was $217, from 43 plans available, the report said.

"The rates in Texas are looking good," said Gary Cohen, who is charged with overseeing the exchanges at the Centers for Medicare and Medicaid Services.

Insurance industry surveys show rates are the most important factor in drawing consumers to the exchanges, which is key to making the healthcare overhaul work.

Another concern has been that insurance companies will limit access to doctors to keep prices low. Cohen said that these so-called "narrow networks" were a trend before the Affordable Care Act took effect.

The law was adopted in 2010, but two of its main pillars, the health exchanges and the expansion of Medicaid, take effect in 2014. Household names like UnitedHealth Group Inc, Aetna Inc, WellPoint Inc and Humana Inc will sell plans on at least some exchanges. Newcomers such as Medicaid specialist Molina Healthcare Inc will also play a role.

(Additional reporting by Lewis Krauskopf in New York and David Morgan in Washington D.C.; Editing by Michele Gershberg, Lisa Shumaker and Lisa Von Ahn)


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Burger King debuts lower-fat french fries

n">(Reuters) - Burger King Worldwide Inc, known for its "Whopper" hamburgers, has introduced lower-fat french fries as consumer groups and nutrition experts in the United States increase pressure on the food industry to offer healthier alternatives.

The Miami-based hamburger chain late on Monday said its new "Satisfries" contain 40 percent less fat and 30 percent fewer calories than those sold by archrival McDonald's Corp, which is widely considered to have the fast-food industry's most popular french fries.

McDonald's declined on Tuesday to say whether it will offer its own lower-fat fries.

Some restaurant operators are embracing healthier food in large part because many consumers will pay a bit more for it.

To that end, Burger King will sell its new fries for a premium, at a suggested price of $1.89 for a small portion versus $1.59 for its existing fries. A small serving of the new Satisfries has 270 calories and 11 grams of fat, while the older Burger King fries have 340 calories and 15 grams of fat.

Burger King's new fries are crinkle-cut and thinly coated with a batter that absorbs less oil, the company said. They were developed in partnership with french fry supplier McCain Foods and are exclusive to Burger King, a spokeswoman told Reuters.

More than one-third of Americans are obese, and about 10 percent of the U.S. healthcare bill is tied to obesity-related illnesses such as Type 2 diabetes, heart disease and hypertension, according to the Organization for Economic Co-operation and Development.

The Center for Science in the Public Interest is among the groups lobbying the U.S. food industry to make healthier products.

Margo Wootan, its director of nutrition policy, called Burger King's new fries a "step in the right direction" and urged the chain to do more.

"If people are going to eat fries, the new fries are an improvement," Wootan said. "Now Burger King needs to get as inventive with other vegetables and add more to the menu."

(Reporting by Lisa Baertlein in Los Angeles and Sakthi Prasad in Bangalore; Editing by Sophie Walker and Jim Marshall)


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Omega-3s not tied to women's mental sharpness

By Genevra Pittman

NEW YORK | Wed Sep 25, 2013 4:12pm EDT

NEW YORK (Reuters Health) - Women who consume plenty of omega-3 fatty acids may not have better thinking and memory skills as a result, according to a new study.

Some researchers have suggested that fatty acids found in fish and fish oil supplements might protect against memory loss.

But studies trying to test that theory have been "all over the place," said Dr. Jennifer G. Robinson from the University of Iowa in Iowa City, senior author of the new report.

"There's nothing really convincing, (in) one direction or the other," she told Reuters Health.

To address the uncertainty, she and her colleagues analyzed data collected as part of the large Women's Health Initiative trial focused on hormone replacement therapy.

For the new study, they compared women's fatty acid levels to their performance on six years' worth of thinking and memory tests.

The study included 2,157 women ages 65 to 80, and Robinson's team looked at their levels of two omega-3 fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The researchers also adjusted for the effects of hormone therapy in the women who were taking it.

On seven kinds of thinking and memory tests, Robinson and her colleagues found no differences between the one-third of women with the lowest omega-3 levels and the one-third with the highest levels.

That was after also taking into account other health and lifestyle factors, like whether women smoked and how much they exercised.

The tests measured women's short-term memory for numbers and pictures and their ability to recognize shapes that are flipped or rotated, for example.

Scores on those exams did decline gradually over time, but there was no link between a woman's omega-3 levels and how far or fast her scores fell, the study team reports in Neurology.

Robinson said Women's Health Initiative participants tended to be healthy and well-educated, which may have bolstered their "cognitive reserve" and protected against memory loss - even without extra omega-3 fatty acids. It's possible, she added, that the fatty acids would make a bigger difference among less-advantaged women.

Or, it may be that researchers would have to measure fatty acids over longer periods of time to see a link with thought processing. The blood levels used here probably only reflect diet over several months, she said.

"It's just one snapshot, one point in time," Robinson said. "The feeling as we look at all these chronic diseases … is it's really what happens over your lifetime that's important in terms of diet and physical activity."

Alan Dangour, who has studied fatty acids and memory at the London School of Hygiene and Tropical Medicine, said omega-3s are important for brain development early in life. But after that, the data get a bit fuzzier.

"There is no good evidence to support the consumption of omega-3 supplements to promote or maintain cognitive health in later life," Dangour, who wasn't involved in the new research, told Reuters Health in an email.

"However, omega-3 fatty acids are an important part of the diet and may have other health benefits," he said.

SOURCE: bit.ly/Q5TNl Neurology, online September 25, 2013.


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As ad war heats up, White House pushes to enroll millions in Obamacare

By David Morgan

WASHINGTON | Tue Sep 24, 2013 7:37pm EDT

WASHINGTON (Reuters) - The White House on Tuesday kicked off a six-month campaign to encourage millions of Americans to sign up for health coverage under "Obamacare," an effort in which the president and other political celebrities promote the law's promise of subsidized health coverage.

But the massive public education campaign faces a long, difficult slog to persuade nearly 3 million healthy young people with low to moderate incomes to purchase private insurance. Many of them live in conservative, Republican-led states where opponents are spending millions of dollars to discourage enrollment in Obamacare's new, online health insurance marketplaces beginning October 1.

In promoting his signature legislative achievement on Tuesday, President Barack Obama sought to leverage his popularity among young adults by joining former President Bill Clinton - who also is popular with that age group - for a "conversation" in New York about healthcare.

First lady Michelle Obama and Vice President Joe Biden also are joining the Obamacare campaign, with separate appearances elsewhere. On Wednesday, former Secretary of State Hillary Clinton - who as first lady two decades ago led an unsuccessful attempt to revamp the U.S. healthcare system - will speak about healthcare at the annual meeting of the Clinton Global Initiative, her family's nonprofit foundation.

Next week, consumers in most states will begin to see more social media promotions from the Obama administration, targeting young adults in urban areas that are home to many of the nation's estimated 47 million uninsured people, according to senior administration officials.

The effort coincides with an expected $1 billion marketing initiative from health insurers, hospitals and health systems, as well as public outreach efforts by groups ranging from AARP, churches and charities to the Walgreen and CVS pharmacy chains, officials said.

"This is a Normandy invasion of the health system," said Uwe Reinhardt, a healthcare economist at Princeton University. "Eventually, lower-income people will be pleasantly surprised at how little health insurance will cost them with the subsidies."

Administration officials are confident that the Patient Protection and Affordable Care Act's initial six-month enrollment period, which runs through March 31, will meet its target of extending coverage to 7 million uninsured people, including 2.7 million adults aged 18-35 who are largely male and black or Latino. An estimated 33 million uninsured Americans could benefit from the program, officials say.

BIG SPENDING BY OBAMACARE FOES

The enrollment drive will have to overcome waves of ads from Republican, conservative and business groups that say Obamacare amounts to unwanted socialized medicine that will raise costs for businesses, eliminate thousands of jobs and force some people who already have health insurance to pay more for it.

Obamacare's critics already have launched a series of ads, ranging from sarcastic to fear inspiring, that are aimed at discouraging young adults from signing up.

Kantar Media's Campaign Media Analysis Group, which monitors political advertising, says that more than $500 million has been spent on Obamacare-related political advertising since the program became law in 2010.

Anti-Obamacare ads have outnumbered supportive messages by more than a 4-to-1 ratio, Kantar says. Analysts say the massive spending by Obamacare foes has contributed to Obamacare's shaky showing in recent opinion polls.

New Reuters/Ipsos polling data showed Tuesday that 46 percent of Americans disapproved of Obama's handling of the healthcare overhaul, passed by Congress four years ago.

Up to now, disapproval rates have not reflected the views of younger adults who could benefit from Obamacare. But over the summer, Obamacare's foes began targeting two major demographic targets for the administration: young people and women.

Generation Opportunity, a conservative group that appeals to the young, has two "Creepy Uncle Sam" videos that picture young Obamacare enrollees being confronted in a medical examination room by a sinister-looking Uncle Sam. In one, a smiling Uncle Sam startles a young woman during a gynecological exam.

"Don't let government play doctor," the video warns. "Opt out of Obamacare."

The same group intends to hold anti-Obamacare events on 20 college campuses in the coming months.

Americans for Prosperity, another conservative group, has spent millions on television ads in selected states that show mothers and other women worrying about whether their healthcare will suffer with the government "in the middle of things."

But opposition ads may have difficulty short-circuiting the Obamacare campaign, which will rely heavily on alternative channels such as the Spanish-language cable channel Univision, African-American radio stations, and the social media Web sites Facebook and Twitter.

Many of the administration's marketing targets are similar to those in Obama's 2012 re-election campaign.

"The Obama campaign proved in 2012 that they could defy everyone's expectations by turning out unexpectedly large numbers of young people and Latinos. They're certainly justified in feeling confident that they can do it again," said Elizabeth Wilner of the Campaign Media Analysis Group.

The White House's biggest hurdle could be informing people that benefits exist. Only about half of those who would gain coverage know about the benefits, organizers say, adding that most new enrollees may not sign up until 2014.

Others disagree, saying the rollout may do well in the 16 states that have their own healthcare marketplaces, including California, but that things might not go as well in conservative "Red" states such as Texas.

"California and Texas will look like different countries where healthcare's concerned," said Robert Blendon, who tracks the politics of healthcare at Harvard University.

"This is a local implementation issue," Blendon said. "It's not a president, first lady, Joe Biden issue. But they don't know what else to do, so they're going with the army they've got, and that's what they know from elections."

(Additional reporting by Caren Bohan, Mark Felsenthal, Roberta Rampton and Andy Sullivan; Editing by David Lindsey and Ken Wills)


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Sanofi cholesterol drug touted as potential $3 billion blockbuster

By Natalie Huet

PARIS | Wed Sep 25, 2013 11:53am EDT

PARIS (Reuters) - A new cholesterol-lowering drug from Sanofi and Regeneron has the potential to become a $3-billion-dollar-plus blockbuster, according to analysts awaiting imminent late-stage trial results.

The drug, dubbed alirocumab, is part of a group of biotech medicines known as PCSK9 inhibitors that offer a new way of fighting the build-up of artery-clogging fatty deposits that put millions of patients worldwide at risk of heart attacks.

PCSK9 inhibitors are eyed as potentially the biggest advance in the fight against heart diseases since statin drugs such as Lipitor and Zocor, now widely available as cheap generics, were launched more than two decades ago.

The drugs are self-injectable, man-made antibodies targeting a protein that prevents the body from eliminating "bad" LDL cholesterol from the bloodstream. They work differently from statins - pills that inhibit the liver's production of LDL cholesterol in the first place.

"Physician feedback suggests high awareness amongst cardiologists and planned prescribing habits support multi-billion dollar potential for the class," Deutsche Bank analysts wrote in a note on Wednesday, forecasting peak annual sales of alirocumab of more than $3 billion.

Independent research firm BioMedTracker sees sales of alirocumab reaching $3.7 billion by 2023.

Sanofi and U.S. biotech firm Regeneron are among leaders in the race to bring a drug from this new class to market, neck-and-neck with Amgen. Pfizer, Eli Lilly and Roche have rival products at earlier stages of clinical development.

If positive, results from a first 100-patient trial - due any day now - will boost Sanofi's confidence in its drug, which may reach the market by 2015. But its ultimate success depends on longer-term studies involving thousands of patients, some of which will only produce results in around five years.

In the first Phase III study, alirocumab, which has cut levels of LDL cholesterol by up to 72 percent in Phase II trials, is being tested against Merck's Zetia, which can lower LDL cholesterol by 19-24 percent. Deutsche analysts expect it to easily achieve its goal in the trial.

PRICE HURDLE

Alirocumab is likely to used in patients with genetically-high cholesterol levels, high-risk patients who do not hit their cholesterol goals on statins alone, and patients intolerant to statins, whose side effects can include muscle pain.

Doctors at the European Society of Cardiology congress in Amsterdam earlier this month said PCSK9 drugs could be a valuable new weapon against heart disease.

But many were wary of predicting widespread use before seeing final-stage clinical data, following past disappoints with other heart drugs, including pills raising "good" HDL cholesterol.

The requirement for the new medicines to be injected and their expected high cost are also seen as potential deterrents, with pricing expected to be especially an issue in Europe, where healthcare spending is pressured by deficit-slashing policies.

For alirocumab, analysts expect a price of around $15 per day, comparable to the cost of injectable diabetes drugs known as GLP-1s, such as Novo Nordisk's Victoza.

At an investor conference earlier this month, Sanofi's CEO Chris Viehbacher said the French drugmaker could look at nearly doubling its stake in Regeneron, voicing confidence in the drug's success.

"When you look at the number of patients who are willing to inject themselves daily for diabetes, and you know a lot of those patients are also going to be in your patient population for PCSK9, I actually think that the injectable part is not going to be as big a barrier as people think," Viehbacher said.

"I think it is going to be a paradigm shift for healthcare and a potentially huge opportunity for us."

(Additional reporting by Ben Hirschler in London; Editing by David Cowell)


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Infinity Pharma's cancer drug fails mid-stage trial goals

n">(Reuters) - Infinity Pharmaceuticals Inc said its cancer drug failed to improve overall survival in a mid-stage study on patients with non-small cell lung cancer who had a history of smoking.

The drug, retaspimycin HCl, also failed to improve overall survival in patients with squamous cell carcinoma, a type of non-small cell lung cancer that is closely linked to smoking.

The company said it will not start any new trials with the drug, but would complete enrollment in a separate study by the end of the year.

Infinity said it will now focus on developing IPI-145, which it is testing to treat advanced blood cancers, asthma and rheumatoid arthritis.

The company tested retaspimycin HCl in combination with docetaxel, an approved cancer drug, comparing it with a combination of docetaxel and placebo in patients who failed to respond to prior treatment.

Infinity said the safety of the drug plus docetaxel was comparable to docetaxel and placebo.

The company's fell nearly 2 percent to $17.99 in early trade on Wednesday.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sriraj Kalluvila)


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FDA strengthens hepatitis B warning on 2 cancer drugs

WASHINGTON | Wed Sep 25, 2013 12:33pm EDT

WASHINGTON (Reuters) - U.S. health regulators have strengthened the warnings on two blood cancer drugs to reflect the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease.

The warnings affect GlaxoSmithKline Plc's Arzerra, which was approved in the United States in 2009 to treat chronic lymphocytic leukemia (CLL); and Rituxan, a drug made by Roche Holding AG and Biogen Idec Inc that is approved to treat a variety of conditions including CLL, non-Hodgkin's Lymphoma and rheumatoid arthritis.

The U.S. Food and Drug Administration said the risk is already described in the warnings and precautions section of the label for both drugs but that cases of reactivation continue to occur and some patients have died. Now the information will be placed in a black box, indicating the most serious type of risk.

The FDA said it recommends that physicians screen all patients for hepatitis B infection before starting treatment with the drugs, and monitor patients with evidence of prior hepatitis B infection for signs that the virus has been reactivated, including for several months after therapy has stopped.

Both drugs work be suppressing the body's immune system, which is critical in fighting infections. Hepatitis B is a serious liver infection that can become chronic and lead to liver failure, liver cancer or cirrhosis, a condition that causes permanent scarring of the liver. It is spread through contact with blood and body fluids. The best way to prevent the disease is through vaccination.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick and David Gregorio)


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Anglo South Africa settles silicosis case with 23 gold miners

By Ed Cropley

JOHANNESBURG | Wed Sep 25, 2013 7:43am EDT

JOHANNESBURG (Reuters) - Anglo American's South African arm has settled a compensation claim by 23 gold miners with the lung disease silicosis, bringing an industry-wide deal potentially worth hundreds of millions of dollars closer, a lawyer said on Wednesday.

Details of the settlement are confidential although Richard Meeran, the London-based lawyer who first brought the suit against the global mining giant in 2004, said he and his clients were "very happy" with the deal.

Anglo American sold off its gold assets over a decade ago but this suit and similar initiatives are based on its past as a bullion producer.

The firm said the settlement involved no admission of liability and was in the best interests of the plaintiffs, their families and the company.

"Technically, no legal precedent has been set but the fact of this settlement sends a signal," Meeran told a news conference in Johannesburg. "This settlement today shows that the writing is on the wall for the industry."

Of the 23 initial claimants, eight have already died of silicosis, an illness caused by the inhalation of tiny particles of silica dust from gold-bearing rocks over many years without adequate protection.

It causes shortness of breath, a persistent cough and chest pains, and makes its victims highly susceptible to tuberculosis.

Tens of thousands of black miners from South Africa and neighboring countries are believed to have contracted silicosis during the decades of apartheid rule, when their health and safety were not priorities of the white gold barons.

"We continue to work with industry, government and civil society to tackle the many challenges of primary health care in South Africa," Anglo American said in a statement.

The Meeran suit is one of several being brought on behalf of silicosis victims against South Africa's once-mighty gold industry and had been scheduled for arbitration in February before a panel of senior South African judges.

In another case, human rights lawyer Richard Spoor filed an application in December for a class action suit on behalf of 17,000 former gold miners from South Africa, Botswana and Lesotho against more than 30 gold firms, including AngloGold Ashanti, Gold Fields and Harmony.

The case, which has little precedent in South African law, would be likely to be Africa's biggest class action suit and could result in a payout running into the hundreds of millions of dollars.

Spoor's suit is based on a 2011 constitutional court ruling in favor of a silicosis-afflicted miner called Thembekile Mankayi, who was seeking $342,000 in compensation for pain and suffering, loss of earnings and medical expenses.

Mankayi died shortly before the 2011 ruling was delivered.

(Editing by Ed Stoddard and Keiron Henderson)


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Merck KGaA revives testing of cancer vaccine

By Ludwig Burger

FRANKFURT | Wed Sep 25, 2013 3:50am EDT

FRANKFURT (Reuters) - German drugmaker Merck KGaA will conduct new tests on an experimental lung cancer vaccine which failed a previous late-stage clinical trial, it said on Wednesday.

Merck said it would test the drug formerly known as Stimuvax and now called tecemotide on patients that had been given chemotherapy and radiotherapy simultaneously in an initial round of treatment.

The previous trial, which also included patients that had been given chemotherapy and radiotherapy separately, failed to provide evidence of improved survival.

The drug - licensed from U.S. biotech firm Oncothyreon - will be tested on patients with locally advanced Stage III non-small cell lung cancer (NSCLC), which cannot be surgically removed, unchanged from the previous trial called START, the firm said.

"The START data delivered important insights that we believe justify further investigation in a new Phase III programme," said Annalisa Jenkins, Merck's head of drug development.

Developing cancer vaccines that prime the immune system to attack tumour cells, is a high-risk, high-reward field of medicine that has seen a string of setbacks.

An experimental cancer vaccine from GlaxoSmithKline failed to help melanoma patients in a closely watched clinical trial. Dendreon Corp's Provenge, a pioneer cancer vaccine, has failed to meet sales expectations.

Merck said detailed analysis of the previous trial showed that patients with a treatment history of simultaneous chemotherapy and radiotherapy had an overall survival of 30.8 months after taking tecemotide, versus 20.6 months in a control group of patients treated with placebo.

Investors took a cautious stance, with shares in Merck trading 0.2 percent lower at the open.

The German company said about 1,000 patients would take part in the new study, called START2, compared with 1,200 participants in the predecessor START trial.

The company did not say by how much it was reducing its target market by focusing on a smaller subset of patients, but it described simultaneous chemotherapy and radiotherapy as the current standard of care.

(Reporting by Ludwig Burger; Editing by Mark Potter)


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Sanofi starts work on $95 million Algerian plant, biggest in Africa

PARIS | Thu Sep 26, 2013 7:43am EDT

PARIS (Reuters) - French drugmaker Sanofi has started construction of a new 70 million-euro ($95 million) plant in Algeria that will be its largest industrial site in Africa, the company said on Thursday.

Sanofi, the international drug company with the biggest sales in Africa, already has two other manufacturing sites in Algeria and Chief Executive Chris Viehbacher described Africa earlier this year as "an extremely interesting market".

With new opportunities opening up for treating chronic diseases afflicting Africa's middle classes, rather than just fire-fighting infections, the region is attracting growing attention from European drug firms like Sanofi and GlaxoSmithKline.

According to forecasts by pharmaceuticals consultancy IMS Health, medicine spending in Africa is expected to reach $30 billion by 2016, driven by an annual growth rate of more than 10 percent.

(Reporting by Ben Hirschler; Editing by Greg Mahlich)


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Natural nerves improve robotic leg performance

By Gene Emery

NEW YORK | Wed Sep 25, 2013 5:03pm EDT

NEW YORK (Reuters Health) - Redirecting nerves from the thigh muscle to control an experimental robotic leg makes it easier to use and more like a natural leg, researchers report.

The leg's movements are guided by the patient's original nerves, which have been redirected to a small area of the thigh muscle. The robotic leg senses the unconscious muscle movements and translates them into movements for the knee and ankle of the 10-pound device.

"This technology offers a seamless transition to walking around, climbing stairs, and descending stairs and moving around on slopes and even repositioning the prosthesis without thinking about it. That's something no other device offers now," Levi Hargrove of the Rehabilitation Institute of Chicago told Reuters Health.

Zac Vawter, who lives in the Seattle area and lost his right knee following a motorcycle accident at age 31, has been testing the device and is the subject of a case report by Hargrove and colleagues in The New England Journal of Medicine.

In a news release, Vawter said the bionic leg "is a big improvement compared to my regular prosthetic leg" because it "responds quickly and more appropriately, allowing me to interact with my environment in a way that is similar to how I moved before my amputation."

The device is one of many ongoing attempts to develop powered artificial limbs that reproduce the complex process of walking - both to help restore motion to amputees or for people with other problems such as spinal cord injuries. But all have their limitations.

The robotic leg is being developed with an $8 million grant from the U.S. Army. There are more than one million lower leg amputees in the U.S.

Troy Turner, a member of the scientific advisory panel of The Amputee Coalition in Manassas, Virginia, said the project "represents the first true effort at letting someone control their prosthetic leg in a way that's very similar to biologic control."

Turner, who is a rehabilitation and human performance portfolio manager with the U.S. Army's Medical Research and Materiel Command in Fort Detrick, Maryland, estimated that only about four to six groups are researching the problem on this high level.

"I think this will be the first real successful effort in making it commercializable. It also lays the groundwork for a lot of continued efforts in taking this concept much further," he said.

A similar system has been used in robotic arms for years. But the challenge is greater in developing a robotic leg, according to Hargrove, because users of a robotic arm don't face a serious risk of falling if the signals are misread.

"If you're using a bionic arm and it misbehaves, the elbow may move slightly. If the prosthetic leg misbehaves … that could be quite a safety issue," Hargrove said.

In addition, "it has to be able to hold the person's weight, generate huge amounts of torque and power to help push a person along or lift them up the stairs. So strictly from a mechanical engineering standpoint, it's very very difficult to actually design a robotic leg," he said.

The leg does have limitations, the researcher said. "We need to make it lighter, quieter, have the battery life that lasts a bit longer" and reduce the movement error rate. The current model is good for about 5,000 steps. The Army's goal is 10,000 steps.

The work was done in conjunction with Vanderbilt University in Nashville and researchers from Northwestern University in Evanston, Illinois, and the University of Seattle.

SOURCE: bit.ly/15fq8aB New England Journal of Medicine, online September 25, 2013.


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Computer snags delay parts of Obamacare in some U.S. states

By Sharon Begley

NEW YORK | Wed Sep 25, 2013 9:34pm EDT

NEW YORK (Reuters) - The District of Columbia's online health insurance exchange - one of 51 set up under President Barack Obama's healthcare reform law - will be unable to perform two key functions when it opens on October 1, exchange officials announced on Wednesday.

The District joins Colorado and Oregon on the list of "Obamacare" exchanges hobbled by problems with information technology (IT), contributing to expectations that Obama's signature domestic achievement will get off to a slow start when the exchanges go live next Tuesday.

The "DC Health Link" web-based marketplace, where residents of the nation's capital who do not have other coverage will be able to purchase policies, will lack the ability to calculate whether someone is eligible for Medicaid. It will also be unable to calculate the size of federal subsidies, if any, that a customer qualifies for.

Although numerous online tools created by nonprofit and other groups have offered subsidy calculators for months, "calculating subsidies for real is admittedly more complicated," said one expert. "For example, you have to make sure the family isn't eligible for Medicaid, and you have to collect more detail about their income. That said, I am frankly a little mystified why they couldn't get this right in time."

Under the law, someone whose income is less than four times the federal poverty level, or $45,960 for an individual and $110,280 for a family of five, can receive federal subsidies in the form of tax credits to defray the cost of monthly insurance premiums.

Subsidies are key to making the policies fit the budgets of many uninsured Americans, a primary goal of the 2010 Affordable Care Act. Without subsidies, sticker prices for an individual average $328 but can reach hundreds of dollars higher. But with them, according to the Department of Health and Human Services, an estimated 6.4 million people will be able to purchase policies for less than $100 per month.

Not being able to learn how much of a subsidy one qualifies for could therefore be a significant deterrent to applying for coverage.

"DC Health Link is not currently deploying the function that makes new Medicaid eligibility determinations and calculates tax credits," Mila Kofman, executive director of the DC Health Benefit Exchange Authority, said in a statement. The reason, she said, is "a high error rate discovered through extensive systems testing.

People who might qualify for Medicaid coverage or tax credits will be able to submit an online application for coverage if they are willing to do so without knowing what they'll be paying. Experts will determine their eligibility off-line and applicants will be notified in early November, Kofman said.

Her statement emphasized that DC Health Link "will open for business October 1" and said, "We are excited to announce that ... almost all functionality is operational for individual consumers." Only two sentences buried in the nearly 800-word statement mentioned the glitches.

D.C.'s setback is even more severe than other states'.

ACCURACY PROBLEMS

On Monday, employees running Connect for Health Colorado told board members that the exchange would not be able to calculate federal subsidies either, at least for the first few weeks.

Instead, Coloradoans who wish to buy a policy and learn their eligibility for subsidies will be directed to call customer service representatives, who will do the calculations manually.

Connect for Health Colorado was not "completely satisfied" with the accuracy of the tax credit calculations, said Ben Davis, an outside spokesman for the exchange. "There are 100,000 scenarios they want to test for" - combinations of income, family situation and other factors - "and it takes X amount of time. We just did not have enough time to test."

Colorado will therefore spend two more weeks testing the system "to make sure every possible scenario has been accounted for and providing an accurate response," Davis said.

Connect for Health Colorado will have 187 customer service representatives at its call centers throughout the enrollment period, which ends on March 31.

In another potential glitch, Oregon's exchange reported on Wednesday that its IT problems were causing information about policies that insurers plan to sell on Cover Oregon to appear incorrectly on a test site. As a result, crucial details such as deductibles are incorrect.

"We are in a validation process with our carriers," executive director Rocky King said.

State-based exchanges being run by the federal government reported similar display problems last month.

HHS spokeswoman Joanne Peters played down the IT snafus, saying in a statement that "there will be a marketplace open in every state and D.C. on October 1, where families can comparison shop for quality, affordable health coverage."

(Reporting by Sharon Begley, Lewis Krauskopf and David Morgan; Editing by Cynthia Osterman)


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Insight: How new cancer drugs can skip randomized trials

A scientist separates proteins by gel electrophoresis in a lab at the Institute of Cancer Research in Sutton July 15, 2013. REUTERS/Stefan Wermuth

1 of 6. A scientist separates proteins by gel electrophoresis in a lab at the Institute of Cancer Research in Sutton July 15, 2013.

Credit: Reuters/Stefan Wermuth

By Julie Steenhuysen and Ben Hirschler

CHICAGO/LONDON | Thu Sep 26, 2013 2:31am EDT

CHICAGO/LONDON (Reuters) - In 2006 when doctors started testing a melanoma treatment made by Roche Holding AG on patients, they were used to facing slim odds - about one in eight - that the tumors would shrink on chemotherapy. This time, they couldn't believe their eyes.

With Zelboraf, a drug that targets specific mutations in cancer cells, eight out of 10 patients in an early-stage trial experienced significant tumor shrinkage. Roche clearly had a remarkable drug, though it only worked for people with a specific genetic makeup.

Research like the Zelboraf tests, that fine-tune treatments to the genetic profile of patients, is fueling a rethink over how new cancer drugs are tested. The promise: medicines that, in theory at least, can win approval more easily and cheaply.

That also raises ethical questions. If you know a certain treatment is genetically bound to work much better on some people than on others, is it right to conduct randomized trials to see which works best? Zelboraf led some doctors to question whether to go ahead with the trials they had planned, trials that would pit Zelboraf against the standard treatment, a chemotherapy developed in 1975 called dacarbazine.

Some doctors believed that would risk patients' lives unnecessarily. U.S. Food and Drug Administration cancer drug czar Dr. Richard Pazdur pushed for changes to shorten the trial. Others, such as Dr. Patrick Hwu of MD Anderson Cancer Center in Texas, refused to participate in a study that seemed bound to disadvantage some patients.

Ultimately, the trial proceeded and the drug won U.S. approval in 2011. But experts say the controversy over Zelboraf broke the mould, potentially pointing the way to lower-cost drug development.

At least one company has already indicated it will cut prices. Earlier this year, GlaxoSmithKline Plc won approval from the U.S. Food and Drug Administration for Tafinlar, a drug targeting the same mutant genes as Zelboraf, based on a single clinical trial of just 250 patients. It said the drug would cost $7,600 a month, 30 percent less than Zelboraf.

Whether others follow suit in cutting prices will depend on a host of issues, perhaps the biggest of which is the vast difference in the way the United States and Europe regulate drugs.

Pressure is mounting. A new and highly promising class of immunotherapy drugs - which some analysts see as a potential $35 billion a year market - may force companies' hands. These therapies will come to market just as more people are asking if health insurers and governments will keep paying sky-high prices.

Dr. Alexander Eggermont, chief executive of Institut Gustave-Roussy, France's largest cancer center, was one of those who held a hard line on Zelboraf testing, insisting on a randomized trial. But Eggermont now says the standard of proof has changed and he believes immunotherapies - which he calls the "biggest game changer we have ever seen" - will cement the new approach to testing.

"We won't have to do those dinosaur trials," he said. "It will change the whole attitude in drug development."

BETTER SCIENCE

Randomized controlled trials - where some patients are given the treatment that is being tested and others get a "control" substance for comparison - became known as the gold standard of drug testing because they were the most effective way of seeing if a drug worked. But for patients whose cancers are driven by specific genetic mutations, some argue that randomized approach could become obsolete.

"The types of drugs that we're seeing now are different. They are just simply better in terms of efficacy," says Pazdur, the FDA expert who wanted to shorten the Zelboraf trial.

The new drugs are born out of a better understanding of the molecular changes that fuel cancer growth. For example, an estimated 50 to 60 percent of melanoma patients have a specific genetic mutation. Zelboraf and Tafinlar target these people. By testing such treatments only on people with a specific mutation, researchers can work out more quickly, and with fewer patients, if a treatment is effective.

Zelboraf represented a watershed in treating melanoma, a notoriously deadly cancer, although it is not a cure: Most patients eventually develop resistance to the drug. The Zelboraf trial fueled support for a new "breakthrough therapy" regulatory pathway that was signed into U.S. law last year. It could shave years off the traditional drug approval process.

To qualify, a drug must show remarkable clinical activity in early stages of testing. The FDA's Pazdur, who has spent the past 14 years overseeing cancer drug approvals, calls them "knock-your-socks-off" treatments.

He says the FDA has already become more flexible in the kinds of evidence it will accept to speed new cancer drugs to patients.

For example, Stivarga is a pill from Bayer AG for some advanced gastrointestinal tumors. It was approved in February, just three years after the first patient with the condition received it in clinical tests. That's nearly twice as fast as Zelboraf. "That was like a land-speed record," says Dr. George Demetri of the Dana Farber Cancer Institute in Boston, who worked to develop the medicine.

The drug was reviewed under another FDA scheme called the priority review program, which provides an expedited six-month process.

The step-change in the pace of cancer drug development has helped drive a recent improvement in overall pharmaceutical industry productivity. New cancer medicines are the main driver of a pick-up in the number of products coming to market. Since the start of 2012, one third of the 54 drugs approved by the FDA across all diseases areas have been for cancer.

PRICING BACKLASH

But despite the faster approval times, the impact on drug prices so far has been limited.

Clinical trials are the biggest single cost in drug company R&D, accounting for 36 percent of total research expenditure in 2012, according to Thomson Reuters CMR International. Drugmakers traditionally argue that it is only by plowghing an average of a $1 billion-plus into each new medicine that treatments can be improved.

"The costs should be coming down tremendously," said Paul Workman, head of drug discovery at Britain's Institute of Cancer Research. "What's disappointing is that we haven't seen it happen yet. We are in a fascinating but frustrating period of transition."

Don Light, a Harvard professor who is a long-time critic of the drugs industry, is more blunt. He says companies are deliberately clinging to the notion of huge research costs despite the advantages of smaller trials in cancer.

"Claimed high costs are like bragging rights - the higher companies say they are, the more they create the impression of heroism and financial suffering," Light says.

Still, not everyone in the industry is toeing the line. GSK Chief Executive Andrew Witty startled a number of his peers earlier this year by telling a British National Health Service conference that the $1 billion price tag was "one of the great myths of the industry." Since the figure includes the cost of failures, any drug company that can improve its success rate should be able to charge less for new medicines.

"For the first time in my career, pricing is becoming a really interesting piece of the dynamic," Witty said in an interview. "If you believe you have a sustainable model that can churn out more product than anybody else, why wouldn't you do this?"

That could be particularly important as drug companies begin to combine treatments in hopes of achieving longer-lasting benefits. GSK, for instance, has a second melanoma drug called Mekinist that it plans to combine with Tafinlar. Both are cheaper than existing drugs, though combined, of course, they will still cost many thousands of dollars a year.

Doctors are getting restive. In April, more than 100 leukemia specialists from around the world took the unusual step of complaining publicly in the American Society of Hematology's journal Blood that cancer drug prices were "too high, unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems."

With 11 of the 12 cancer drugs launched in the United States last year costing more than $100,000 a year per patient, according to the paper, the debate is not going away.

UNITED STATES VS. EUROPE

But faster trials in the United States won't always translate into cheaper drug development for companies that do business globally, in part because European authorities may not be willing to accept products based on the FDA's more flexible clinical trial standards.

Dr. Eric Rubin, head of oncology clinical development at Merck & Co Inc., said the FDA's willingness to allow accelerated approval based upon single-arm studies - without the traditional control group - is "a big step forward, but it's not universally agreed upon," especially in Europe.

Part of the issue is not with drug safety regulators but with government funding agencies, such as the National Institute for Health and Clinical Excellence, or NICE, Britain's health cost watchdog. It decides whether the state-run health system will pay for a new treatment or drug. It often knocks back expensive drugs as not cost-effective.

"In Europe, it's a different world because you can get a drug approved by the European regulatory agencies - but if the governments won't approve funding for it, people can't access it," Demetri said.

As a result, companies may be forced to into longer, larger trials just to satisfy cost regulators.

"POSITIVE RESULTS"

It's a problem that Merck and other companies developing new immunotherapy drugs will have to solve. The drugs, including Merck's lambrolizumab and Bristol-Myers' nivolumab, help the immune system fight cancer cells by disabling a protein called "programmed death 1" or PD-1 that acts as a brake on the body's ability to detect them.

Andrew Baum, an analyst at Citi, estimates treatments that coax the immune system to target cancer will become the backbone therapy for up to 60 percent of cancers over the next decade, generating $35 billion in annual sales.

Dr. Antoni Ribas at the University of California, Los Angeles says the immunotherapies are showing so much promise that they, like Zelboraf, raise doubts over whether randomized trials are needed. He believes they could be approved in the United States on the basis of a single-arm trial. Yet Merck has started enrolling patients in a study where patients will be randomized to get the new treatment or existing chemotherapy.

One patient who has already put himself forward for lambrolizumab is Stew Scannell, 65, head of operations at global defense company Northrop Grumman in Oklahoma City. Scannell, who served a couple of tours in Vietnam and spent several years in various deserts testing helicopters, figures his melanoma may be the result of cumulative sun damage.

When his doctors were talking about buying him another couple of months, he decided to do his own research. He started lambrolizumab shortly after his first meeting with Ribas, in April 2012.

Several of his tumors have disappeared. At his last scan in April, there was no sign of any tumor in his brain. In Merck's trial, the most common side effects of the drug include fatigue, fevers, skin rash, loss of skin color and muscle weakness. But so far, Scannell has had none. "I really haven't missed a step. I've continued working. The radiation was difficult. But the marvelous thing about the immunotherapy is no side effects. No lethargy. No loss of appetite. No anything."

South African melanoma patient Christina Chrysostomou, 45, would be more than happy to see the end of randomized trials when a treatment has shown early promise.

After her cancer got worse on Bristol-Myers' immunotherapy Yervoy, she and her husband and 8-year-old son headed for the United States in the hopes of trying one of the new anti-PD-1 drugs.

But when she arrived in late June, Merck's Phase I trial had closed, and she was told she would have to take her chances in a randomized test. Luckily for her, a spot opened up in a non-randomized Phase I study and she is now getting lambrolizumab - but she feels for others less fortunate.

"It's really hard knowing there is something out there that could possibly help and having to go through a gamble and maybe not even get that," she said.

(Edited by Sara Ledwith, Richard Woods and Simon Robinson)


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No link between celiac disease and autism: study

By Andrew M. Seaman

NEW YORK | Wed Sep 25, 2013 4:15pm EDT

NEW YORK (Reuters Health) - There's no link between celiac disease and autism spectrum disorders, a nationwide study from Sweden says.

People who were diagnosed with an autism spectrum disorder (ASD) in the study were no more likely to be diagnosed with celiac disease than people without an ASD.

Dr. Jonas Ludvigsson, the study's lead author, said the finding offers one less thing to worry about for people with either celiac or ASDs.

"To them, this is good news," Ludvigsson, of Sweden's Karolinska Institute, said.

Some researchers have reported on single cases of people who were diagnosed with an ASD and who were then diagnosed with celiac disease.

In celiac disease, which is estimated to affect about one percent of Americans, an individual's own immune system attacks the small intestines if they eat gluten, a protein in wheat and certain other grains.

Other studies have found that switching those people to gluten-free diets appeared to also reduce ASD symptoms, but larger trials have not shown any link between the two conditions.

For the new study Ludvigsson and his colleagues connected several Swedish databases to compare the celiac disease diagnoses among people with ASDs to a group of people without the developmental disorders.

The researchers had information on more than 250,000 people and they found no difference in the rate of ASD diagnoses among people with celiac disease compared to those without the condition.

About 44 people per 100,000 were diagnosed with an ASD before they were diagnosed with celiac disease. That compared to about 48 people per 100,000 who were diagnosed with an ASD but not with celiac disease.

There was, however, a link between ASDs and a positive blood test for celiac disease, which alone is not enough to diagnose someone with the condition. A celiac disease diagnosis requires both a positive blood test and evidence of damage to the small intestine.

"It's very interesting in my mind, because it points to some relationship to gluten that's separate from celiac disease," Dr. Peter Green, professor of medicine and director of the Celiac Disease Center at Columbia University Medical Center and a gastroenterologist at NewYork-Presbyterian/Columbia.

But Ludvigsson cautioned that the link between ASDs and a positive celiac blood test is based on a small number of cases. There could be a real relationship between the two or it could be a result of doctors overtesting people with ASDs, he said.

"I want to underline that the positive association we found in this small group could be by chance," Ludvigsson said.

The study also does not shed any light on whether a gluten-free diet improves ASD symptoms, he added.

"I think the next step would be for someone to carry out a well-performed study on a gluten-free diet in autism," Ludvigsson said. "There are several such studies, but my understanding is that they haven't been large enough in size."

Green, who was not involved in the new report, agreed that people can't draw any conclusions on gluten-free diets for autism.

"This (study) provides some evidence that there may be a role, but it may also help to find those who would possibly benefit from this therapy," he said.

Ludvigsson, who published his findings in JAMA Psychiatry, said it's also important to examine possible relationships between celiac disease and other "neurocognitive" disorders.

"Our study is definitive when it comes to refuting an association between celiac disease and autism, however, we can't rule out that autism is related to other intestinal conditions that do not fulfill the traditional criteria of celiac disease," he added.

SOURCE: bit.ly/P0ZWgC JAMA Psychiatry, online September 25, 2013.


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Panel urges awareness of student-athlete mental health

By Genevra Pittman

NEW YORK | Wed Sep 25, 2013 4:21pm EDT

NEW YORK (Reuters Health) - Athletic trainers should be on the lookout for mental health problems among student-athletes, a panel said on Wednesday.

Representatives from the National Athletic Trainers' Association, the American Academy of Pediatrics and other organizations said athletic trainers are in a unique position to reach out to college athletes and refer them to counseling.

"As an athletic trainer, we're usually right there with the student-athletes during some of their worst moments," Timothy Neal, chair of the task force and assistant director of athletics for sports medicine at Syracuse University in New York, said. "You have their trust."

About 30 percent of college-aged people reported having some type of mental illness during 2010 and 2011, according to the Substance Abuse and Mental Health Services Administration.

Neal said he has seen everything from athletes with anxiety and eating disorders to those who are suicidal. Some students come to him for help, but in other cases he reaches out when it seems like something's not quite right.

"What I look for is someone who is acting opposite of as you know them - someone who's more irritable than they normally would be, someone who's more withdrawn than they normally would be," Neal told Reuters Health.

When that's the case, athletic trainers should approach students and offer to refer them for counseling services at the school or in the community. It helps to already have a relationship with those services, Neal said, and to talk with mental health counselors about the particular stressors facing student-athletes.

Athletic trainers should also be prepared to make an emergency referral if student-athletes are a threat to themselves or others, the task force noted. Trainers should follow the protocol of their institution and call law enforcement if the person is violent.

Neal said he talks with student-athletes at the beginning of every season about the importance of psychological health to try to reduce the stigma associated with having a mental health problem.

It can be especially difficult to convince athletes that it's okay to have a mental illness, Dr. Thomas L. Schwenk, dean of the University of Nevada School of Medicine in Reno, who has studied mental illness among athletes, said.

"With special populations, especially populations of people who are particularly goal-oriented, particularly high achievers, particularly focused, there still is a sense of stigmatization, a sense of shame," Schwenk, who was not part of the task force, told Reuters Health.

"We still have to work really hard with special populations like student-athletes to help them understand that they get sick just like everybody else, they have mental health problems just like everybody else."

A particular time to be aware of psychological issues is when athletes get injured and have to take time out from their sport, according to the task force's recommendations, published in the Journal of Athletic Training.

"Many athletes especially at a collegiate level identify themselves as a person as an athlete," Neal said. So when they get hurt, they may start losing that identity and feel isolated.

Schwenk said underlying mental illnesses such as depression also occur among athletes. Symptoms don't have to stem from athletic-related stress, he pointed out.

He said one strategy for reaching out to athletes is to frame mental healthcare as a way to improve their performance in their sport.

"An athlete may not be too enthused," Schwenk said, "until you say, ‘This is the way you can be better.'"

SOURCE: bit.ly/14HXQbE Journal of Athletic Training, online September 25, 2013.


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Acupuncture as good as counseling for depression: study

By Andrew M. Seaman

NEW YORK | Tue Sep 24, 2013 5:02pm EDT

NEW YORK (Reuters Health) - People with depression may benefit as much from acupuncture as they do from counseling, suggests a new study.

Researchers found one in three patients was no longer depressed after three months of acupuncture or counseling, compared to one in five who received neither treatment.

"For people who have depression, who have tried various medical options, who are still not getting the benefit they want, they should try acupuncture or counseling as options that are now known to be clinically effective," said Hugh MacPherson, the study's lead author from the University of York in the UK.

Previous studies looking at whether acupuncture helps ease depression have been inconclusive. Those studies were also small and didn't compare acupuncture to other treatment options.

"What's more important for the patient is does it work in practice and that is the question we were asking," MacPherson said.

For their study, he and his colleagues recruited 755 people with moderate or severe depression. The researchers split participants into three groups: 302 were randomly assigned to receive 12 weekly acupuncture sessions, another 302 received weekly counseling sessions and 151 received usual care only.

About 70 percent of people had taken antidepressants in the three months before the study and about half reported taking pain medications. People did not have to stop taking their medicine to participate in the study.

At the outset, participants had an average depression score of 16 on a scale from 0 to 27, with higher scores symbolizing more severe depression. A 16 is considered moderately severe depression.

After three months, people assigned to the acupuncture group had an average score of about 9 - on the higher end of the mild depression category. Scores fell to 11 among members of the counseling group and about 13 in the usual care group, both considered moderate depression.

Participants who received acupuncture or counseling saw larger improvements over three months than those who had neither treatment. Those benefits remained for an additional three months after the treatments stopped.

However, any differences between acupuncture and counseling could have been due to chance, the researchers reported Tuesday in PLOS Medicine.

They found doctors would need to treat seven people using acupuncture and 10 people with counseling for one person to no longer be depressed.

"What this says is if you don't get completely better, there are other options," Dr. Philip Muskin, a psychiatrist at Columbia University Medical Center in New York, told Reuters Health.

"One option would be to take a different medication, but by this study these would be valid options," said Muskin, who was not involved with the new research.

He cautioned, however, that counseling and acupuncture are not replacements for medication. The majority of study participants were still taking antidepressants at the end of the three months.

Muskin said the study also doesn't show what types of patients respond best to acupuncture or counseling.

"What I can't tell from this study is who's who. Not everybody got better," he said.

MacPherson said it's best to ask patients for their treatment preference.

"If you talk to people, they would almost always have a leaning one way or the other," he said.

Acupuncture is only covered by health insurance in the UK for chronic pain, MacPherson said. In the U.S., some plans also cover acupuncture for pain or nausea.

According to online information from the Mayo Clinic, the risks of acupuncture are low if people hire competent and certified practitioners. Complications can include soreness, organ injury and infections.

"Cleary acupuncture is a new option," MacPherson said. "This is the first evidence that acupuncture really helps."

SOURCE: bit.ly/1803MNo PLOS Medicine, online September 24, 2013.


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As ad war heats up, White House pushes to enroll millions in Obamacare

By David Morgan

WASHINGTON | Tue Sep 24, 2013 7:37pm EDT

WASHINGTON (Reuters) - The White House on Tuesday kicked off a six-month campaign to encourage millions of Americans to sign up for health coverage under "Obamacare," an effort in which the president and other political celebrities promote the law's promise of subsidized health coverage.

But the massive public education campaign faces a long, difficult slog to persuade nearly 3 million healthy young people with low to moderate incomes to purchase private insurance. Many of them live in conservative, Republican-led states where opponents are spending millions of dollars to discourage enrollment in Obamacare's new, online health insurance marketplaces beginning October 1.

In promoting his signature legislative achievement on Tuesday, President Barack Obama sought to leverage his popularity among young adults by joining former President Bill Clinton - who also is popular with that age group - for a "conversation" in New York about healthcare.

First lady Michelle Obama and Vice President Joe Biden also are joining the Obamacare campaign, with separate appearances elsewhere. On Wednesday, former Secretary of State Hillary Clinton - who as first lady two decades ago led an unsuccessful attempt to revamp the U.S. healthcare system - will speak about healthcare at the annual meeting of the Clinton Global Initiative, her family's nonprofit foundation.

Next week, consumers in most states will begin to see more social media promotions from the Obama administration, targeting young adults in urban areas that are home to many of the nation's estimated 47 million uninsured people, according to senior administration officials.

The effort coincides with an expected $1 billion marketing initiative from health insurers, hospitals and health systems, as well as public outreach efforts by groups ranging from AARP, churches and charities to the Walgreen and CVS pharmacy chains, officials said.

"This is a Normandy invasion of the health system," said Uwe Reinhardt, a healthcare economist at Princeton University. "Eventually, lower-income people will be pleasantly surprised at how little health insurance will cost them with the subsidies."

Administration officials are confident that the Patient Protection and Affordable Care Act's initial six-month enrollment period, which runs through March 31, will meet its target of extending coverage to 7 million uninsured people, including 2.7 million adults aged 18-35 who are largely male and black or Latino. An estimated 33 million uninsured Americans could benefit from the program, officials say.

BIG SPENDING BY OBAMACARE FOES

The enrollment drive will have to overcome waves of ads from Republican, conservative and business groups that say Obamacare amounts to unwanted socialized medicine that will raise costs for businesses, eliminate thousands of jobs and force some people who already have health insurance to pay more for it.

Obamacare's critics already have launched a series of ads, ranging from sarcastic to fear inspiring, that are aimed at discouraging young adults from signing up.

Kantar Media's Campaign Media Analysis Group, which monitors political advertising, says that more than $500 million has been spent on Obamacare-related political advertising since the program became law in 2010.

Anti-Obamacare ads have outnumbered supportive messages by more than a 4-to-1 ratio, Kantar says. Analysts say the massive spending by Obamacare foes has contributed to Obamacare's shaky showing in recent opinion polls.

New Reuters/Ipsos polling data showed Tuesday that 46 percent of Americans disapproved of Obama's handling of the healthcare overhaul, passed by Congress four years ago.

Up to now, disapproval rates have not reflected the views of younger adults who could benefit from Obamacare. But over the summer, Obamacare's foes began targeting two major demographic targets for the administration: young people and women.

Generation Opportunity, a conservative group that appeals to the young, has two "Creepy Uncle Sam" videos that picture young Obamacare enrollees being confronted in a medical examination room by a sinister-looking Uncle Sam. In one, a smiling Uncle Sam startles a young woman during a gynecological exam.

"Don't let government play doctor," the video warns. "Opt out of Obamacare."

The same group intends to hold anti-Obamacare events on 20 college campuses in the coming months.

Americans for Prosperity, another conservative group, has spent millions on television ads in selected states that show mothers and other women worrying about whether their healthcare will suffer with the government "in the middle of things."

But opposition ads may have difficulty short-circuiting the Obamacare campaign, which will rely heavily on alternative channels such as the Spanish-language cable channel Univision, African-American radio stations, and the social media Web sites Facebook and Twitter.

Many of the administration's marketing targets are similar to those in Obama's 2012 re-election campaign.

"The Obama campaign proved in 2012 that they could defy everyone's expectations by turning out unexpectedly large numbers of young people and Latinos. They're certainly justified in feeling confident that they can do it again," said Elizabeth Wilner of the Campaign Media Analysis Group.

The White House's biggest hurdle could be informing people that benefits exist. Only about half of those who would gain coverage know about the benefits, organizers say, adding that most new enrollees may not sign up until 2014.

Others disagree, saying the rollout may do well in the 16 states that have their own healthcare marketplaces, including California, but that things might not go as well in conservative "Red" states such as Texas.

"California and Texas will look like different countries where healthcare's concerned," said Robert Blendon, who tracks the politics of healthcare at Harvard University.

"This is a local implementation issue," Blendon said. "It's not a president, first lady, Joe Biden issue. But they don't know what else to do, so they're going with the army they've got, and that's what they know from elections."

(Additional reporting by Caren Bohan, Mark Felsenthal, Roberta Rampton and Andy Sullivan; Editing by David Lindsey and Ken Wills)


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Novartis says "deep regret" over Japan drug trials scandal

By Sophie Knight

TOKYO | Thu Sep 26, 2013 9:13am EDT

TOKYO (Reuters) - The pharmaceutical head at Swiss firm Novartis AG apologized to the Japanese public for alleged manipulation of data in trials of its best-selling blood pressure drug Diovan, saying an employee had acted inappropriately.

Divisional head David Epstein made the comments after meeting with Japanese health minister Norihisa Tamura in Tokyo. He agreed to cooperate with the ministry to resolve the issue.

"We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry," Epstein said.

"We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion," he added, but said he could not specify the type of sanctions ahead of the release of the ministry's findings at the end of this month.

Several Japanese hospitals have stopped offering Diovan after two universities retracted papers printed in foreign medical journals on the drug's efficacy for preventing strokes and heart disease. The other three universities that published research on Diovan are still investigating the matter.

Epstein said that a former Novartis employee who assisted in all five trials had acted "way beyond what we consider appropriate" and that the company had responded by strengthening its training and oversight procedures at Novartis Pharma, its Japanese arm, under new head Yoshiyasu Ninomiya.

Japan is an important market for Novartis, accounting for around a quarter of Diovan's global sales before the scandal. Novartis Pharma declined to disclose the impact on sales of the drug, whose patent is due to end in Japan later this year, allowing competition from generic copycats.

Novartis says the drug is effective for reducing blood pressure and says patients should consult their doctors before they stop taking it.

(Editing by Ben Hirschler)


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Congress moves toward extending worldwide anti-AIDS program

Senate Foreign Relations Committee Chairman Robert Menendez (D-NJ) speaks to the media after the Senate passed the immigration bill on Capitol Hill in Washington June 27, 2013. REUTERS/Yuri Gripas

Senate Foreign Relations Committee Chairman Robert Menendez (D-NJ) speaks to the media after the Senate passed the immigration bill on Capitol Hill in Washington June 27, 2013.

Credit: Reuters/Yuri Gripas

By Patricia Zengerle

WASHINGTON | Wed Sep 25, 2013 8:10pm EDT

WASHINGTON (Reuters) - Senior U.S. lawmakers introduced legislation in the Senate and House of Representatives on Wednesday to extend for another decade a successful and popular program to combat AIDS worldwide launched 10 years ago by former President George W. Bush.

The bills feature several provisions to increase oversight of the President's Emergency Plan for AIDS Relief, known as PEPFAR, due to expire on September 30.

The widely praised program is considered a catalyst for advancing HIV treatment, particularly in Africa. It supports more than 5 million people worldwide who are receiving anti-retroviral drugs.

The measures were introduced by Senators Robert Menendez, Democratic chairman of the Senate Foreign Relations Committee, and Bob Corker, its top Republican; and Representative Eliot Engel, the ranking Democrat on the House Foreign Affairs Committee, and Ed Royce, the panel's Republican chairman.

The new legislation does not include appropriations for the program, which are handled separately. But congressional aides noted PEPFAR enjoys wide support from both parties and said they expected it would be funded.

President Barack Obama's fiscal 2014 budget request included $6 billion for global HIV/AIDS assistance, including $4 billion annually for PEPFAR. The House and Senate's proposed 2014 appropriations bills matched that amount.

Advocates said they welcomed the legislation.

"It's an important signal of recommitment to the PEPFAR program on the part of Congress," Chris Collins, vice president and director of public policy at AmfAR, the Foundation for AIDS Research, told Reuters.

Congress last reauthorized the program in 2008, eliminating a requirement that one-third of all money for HIV prevention be spent on abstinence-only education.

PEPFAR funding has fallen 12 percent since 2010. Critics have accused Obama, a Democrat, of failing to show the same level of commitment to fighting AIDS as his Republican predecessor, Bush, who poured $15 billion into the program to combat AIDS worldwide.

Obama has argued that his administration has expanded the program's scope without increasing spending.

(Editing by Mohammad Zargham)


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Drug subsidy failed to close racial gap in statin use

By Kathryn Doyle

NEW YORK | Wed Sep 25, 2013 3:54pm EDT

NEW YORK (Reuters Health) - Among older Americans with heart disease or diabetes, blacks are still less likely to be on cholesterol medication than whites, despite federal prescription drug subsidies that lowered costs, according to a new study.

Older blacks are also less likely than whites to have their cholesterol under control, researchers found.

Because black patients are more likely to skip doses or to not take expensive medications at all for cost reasons, the Medicare Part D program that started in 2006 was expected to close a racial gap in the number of Americans with heart disease taking statins.

Since the medication gap has not closed after Part D, "It would appear that more than money is involved," said Joseph Hanlon, a professor of geriatric medicine at the University of Pittsburgh who led the study.

"Racial differences in medication use are only partially explained by health insurance," he told Reuters Health. "Differences in quality of care, health status, patient preferences and other factors may also play a role."

Hanlon and his coauthors compared the health data of 1,091 adults over age 70 with coronary heart disease or diabetes receiving Medicare benefits from year to year, checking in every six months from 1998 to 2008.

The data they looked at included cholesterol levels, use of cholesterol controlling drugs like the statin Lipitor and whether cholesterol levels were under control - meaning that low-density lipoprotein, or LDL, "bad" cholesterol was under 130 milligrams per deciliter.

Before 2006, 33 percent of black participants and 49 percent of whites were taking cholesterol medication. That rose to 48 percent and 65 percent, respectively, after 2006, so the gap did not change.

Before Medicare Part D, 55 percent of blacks and 62 percent of whites reported having prescription drug coverage, and that rose to 75 percent and 82 percent after Medicare Part D.

Average LDL cholesterol levels did not seem to improve either, increasing from 107 to 109 milligrams per deciliter for blacks and from 95 to 96 milligrams per deciliter for whites, according to the study results published in the American Heart Journal.

Diligent use of statins by people younger than 80 with heart disease can lower the risk of heart attack, stroke and death, the authors point out. But there is little evidence for benefits over age 85, and at that age the risks of cognitive damage and death due to the medication increase.

Since Lipitor went generic in 2011, it now costs about 50 cents per pill, and some retailers actually offer it for free with a prescription.

Even though cholesterol control didn't appear to change over time, that doesn't mean Medicare Part D had no effect on that health risk factor in the population, said Dr. Walid Gellad, a staff physician at the Pittsburgh VA Medical Center who was not involved in the study.

Just because people reported that they were taking statin drugs doesn't mean that they were taking them often enough, or correctly, Gellad told Reuters Health by email.

Dr. Jennifer G. Robinson, director of the Prevention Intervention Center at the College of Public Health at the University of Iowa in Iowa City, expected Medicare Part D to have had more of an effect.

"More recent studies have found the disparities in prevention and treatments have been narrowing between whites and blacks," she said.

The results may not reflect the effect of Medicare Part D in the nation as a whole, since medication use varies widely by region, Robinson noted. And the apparent overall increase in cholesterol medication use is encouraging, she said.

"It is critically important nationally for more people to achieve lipid control," Gellad said. "However, as the authors explain, it is not so clear how important it is to achieve lipid control for individuals once they reach 80, especially if they have evidence of limited life expectancy."

SOURCE: bit.ly/18QTulH American Heart Journal, online August 27, 2013.


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