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Taste Movie 2015

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Dozens of alcohol-flavored tobacco products may lure teens

(Reuters Health) – Nearly 50 alcohol-flavored tobacco product lines are marketed by more than 400 tobacco brands in the United States and these products may especially attract teens, luring them into tobacco addiction, according to a new study.

Adolescent drinking and smoking tend to go hand in hand, the authors write in the journal Tobacco Control, and the combination of alcohol flavors in tobacco products is sure to appeal to teen users.

So-called characterizing flavors in cigarettes, except for menthol, are banned by the U.S. Food and Drug Administration (FDA), and these restrictions should be extended to the many flavored tobaccos for cigars, cigarillos and hookahs, as well as e-cigarette liquids, they add.

“We were surprised by the large number of brands of alcohol-flavored tobacco products on the market and the wide variety of alcoholic flavors,” said lead author Dr. Robert Jackler of Stanford University in California.

“Not surprisingly, sweet and fruity varieties . . . which appeal to teenagers predominated,” he told Reuters Health by email.

Jackler and colleagues analyzed the top 20 U.S. brands of cigarillos and e-cigarettes using the Nielsen database, which includes unit sales in 25 major chains and 14,000 convenience stores. They also looked for the top hookah and shisha brands online. Then they searched among the top brands for products with flavors related to alcoholic beverages such as beer, appletini and margarita.

The research team found 455 e-cigarette brands and more than 100 flavored cigar, cigarillo and hookah brands. The most popular fruity flavors were pina colada, mojito and margarita, and the most popular spirit flavors were rum, bourbon and whiskey.

The cigars and cigarillos were marketed by large, multinational tobacco companies such as Philip Morris, Imperial Tobacco, Swisher International, Swedish Match and Scandinavian Tobacco Group, and the e-cigarette flavors were nearly all offered by minor brands, the study team notes.

“We found it disturbing that major international tobacco companies, which claim to be socially responsible and who profess they would never target underage youth, produce a wide spectrum of flavored mini-cigars and e-cigarettes, including quite a few with alcohol-themed names,” Jackler said.

In 2009, the FDA banned flavors other than menthol from traditional cigarettes, but rulings about e-cigarettes and other tobacco products are still under discussion. Since 2009, California cities such as San Francisco, Oakland, Sonoma, El Cerrito, Manhattan Beach and Berkeley have banned some flavored tobacco products.

In June, the San Francisco Board of Supervisors unanimously banned flavored tobacco. R.J. Reynolds Tobacco Company, which makes Newport menthol cigarettes, is reported to have spent $ 700,000 on a campaign to collect 34,000 signatures and bring a referendum before city voters. The choice will be on the ballot in June 2018.

“If R.J. Reynolds spent this much money on a local policy in one city, they’re sending a message that these bans could severely hurt their business and affect who smokes,” said Dr. Pamela Ling of the University of California at San Francisco School of Medicine, who wasn’t involved with the study.

“We’re going to see vociferous conversations about tobacco flavors in coming months (in San Francisco),” she told Reuters Health in a phone interview. “I think some people were misled when they were asked to sign the petition and didn’t realize what it was about.”

Jackler and colleagues are now studying how flavored products are advertised to appeal to teens. They’re comparing the differences on social media channels such as Twitter, which predominantly appeals to adult smokers, and Instagram, which appeals to younger smokers, he said.

“Our overall goal is to provide legislators and regulators with the evidence they need to enact effective regulations to protect American teens,” Jackler said.

Ling encourages parents to be informed and take a stand in their communities as well.

“Parents should take action and say they don’t want these products in their stores or neighborhoods,” she said. “There’s not a good scientific reason to leave these products on the market. We should protect our young people.”

SOURCE: bit.ly/2fcHpyA Tobacco Control, August 23, 2017.

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Cans of 'Death Wish' coffee recalled over possible toxin

NEW YORK (Reuters) – Death Wish Coffee Co, a New York coffee maker that sells what it says is the “World’s Strongest Coffee,” is recalling cans of its Nitro Cold Brew because of the risk that some could contain the deadly toxin botulin.

No illnesses have been reported to date, the U.S. Food and Drug Administration (FDA) said in a recall notice earlier this week, but urged people who bought the 11-ounce (325 ml) cans to either dispose of them or return them with proof of purchase for a refund.

Demand for coffee and beer made bubbly with nitrogen, rather than carbon dioxide, has risen over the past year with consumers enjoying the smaller bubbles and the denser foam that the gas produces.

But Death Wish said there is a remote risk that its nitrogen-containing products may contain Clostridium botulinum, a pathogen that can lead to the growth and production of botulin in low acid foods sold in reduced oxygen packaging.

Botulin can lead to a potentially fatal form of food poisoning known as botulism with symptoms including weakness, dizziness, double-vision and trouble speaking or swallowing, according to the FDA.

The founder and owner of Death Wish Coffee Co., Mike Brown, said in a statement that the recall was precautionary, and that the company has passed all FDA and state inspections since it launched the brew.

“If you have it, chuck it out and we’ll cut you a check within 60 days,” the company said in a statement.

Death Wish, which was started in 2012 at a Saratoga Springs coffee shop in New York State, has halted production of Nitro Cold Brew until it can add an extra step to the manufacturing process to eliminate the risk of botulinum being introduced to its product, the FDA said.

Death Wish Coffee said the safety of its customers was of paramount importance, and that the cans were removed from its online store, and that they had been pulled from shelves at Price Chopper/Market 32, Healthy Living Market & Café, and independent retailers at the behest of Death Wish.

“We apologize for the inconvenience this may cause our customers and our retail partners, but we believe this is the right precautionary measure to take,” Brown said in a statement.

Writing by Daniel Wallis, editing by Marcy Nicholson

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U.S. safety board says train crash engineers had undiagnosed sleep disorder

WASHINGTON (Reuters) – The engineers in two New York City area commuter train crashes suffered from sleep apnea that had not been diagnosed, the U.S. National Transportation Safety Board said on Thursday.

The NTSB released factual findings on Thursday regarding its investigations into the crashes and said it planned to hold a meeting next February about both incidents and safety recommendations.

A New Jersey Transit train crashed in Hoboken, New Jersey, in September 2016, killing one person and injuring more than 100.

In January, a Long Island Rail Road train crashed, injuring more than 100 people.

The NTSB said the brakes were working on the New Jersey Transit train that was traveling at 8 miles (13 km) per hour 38 seconds before the crash. The train then accelerated and was moving at 20 mph at impact, twice the speed limit.

The 48-year-old New Jersey Transit engineer underwent a home sleep study in October 2016 that concluded he had severe sleep apnea, the NTSB said.

The agency also said the engineer was obese and had gained more than 90 pounds in the five years before the crash. There was no record of any sleep apnea test being conducted in July 2016 as required by the transit agency, the NTSB said.

According to the Centers for Disease Control being overweight puts individuals at a higher risk of sleep apnea.

In January, the NTSB said the Long Island Rail Road train that crashed into a bumper at the Atlantic Terminal in New York City’s borough of Brooklyn appeared to have been traveling at more than twice the speed limit of 5 mph.

FILE PHOTO: A man sleeps on a bench as people try to commute to New York at the Hoboken Terminal in New Jersey, U.S. July 10, 2017. REUTERS/Eduardo Munoz

The engineer was diagnosed with severe obstructive sleep apnea after the crash, the NTSB said on Thursday.

The LIRR began testing all of its 432 engineers for sleep apnea after the accident and told the NTSB that 34 had been screened through May.

Eight of the 34 had were positive for sleep apnea and were referred for more testing. One other engineer told the LIRR he was being treated for sleep apnea.

In both cases, the engineers had no memory of the crashes.

Sleep apnea, often undiagnosed, is characterized by shallow or interrupted breathing during sleep and can leave sufferers fatigued, according to the U.S. National Institutes of Health.

The Obama administration had been considering requiring truck drivers and railroad engineers to be screened for sleep apnea, but the Trump administration scrapped the effort last month.

U.S. Senator Cory Booker, a Democrat from New Jersey, said in a statement, “These revelations underscore just how shortsighted and reckless the Trump Administration’s recent decision was to roll back common sense steps.”

Representative Bill Pascrell, also a New Jersey Democrat, called the government’s decision to not pursue screening for railroad engineers “shameful.”

The NTSB has called for stricter screening of drivers and engineers for sleep apnea.

In 2014, the NTSB said the driver of a train that derailed in New York City the previous year had an undiagnosed sleep disorder. Four passengers were killed in that accident.

Reporting by David Shepardson

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State funding changes in spotlight in Republican healthcare bill

WASHINGTON (Reuters) – Republican leaders sought to nail down the final votes needed to pass what U.S. Vice President Mike Pence on Thursday called their “last best chance” to repeal Obamacare while a new analysis underscored how Democratic-leaning states stand to lose large amounts of federal funding under the legislation.

Senate Majority Leader Mitch McConnell plans to bring the bill introduced by fellow Republican Senators Lindsey Graham and Bill Cassidy to a vote next week, as his party seeks to make good on seven years of promises to erase Democratic former President Barack Obama’s signature legislative achievement.

With no Democratic support for the bill, Republicans remain a handful of votes short in the Senate, needing 50 votes in a 100-seat chamber they control 52-48, with Pence casting a potential tie-breaking vote. Senator Rand Paul opposes it and at least six others are undecided: John McCain, Susan Collins, Lisa Murkowski, Dan Sullivan, Rob Portman and Jerry Moran.

Asked whether the legislation will pass, Pence said, “We’ll see. We’re close.”

Republicans, still reeling from their failure in July to win Senate passage of previous legislation to repeal and replace Obamacare, have set a Sept. 30 deadline for passage of this bill.

“This may well be our last best chance to stop and turn around and head America back in the direction of the kind of healthcare reform that’s based on individual-choice, state-based innovations,” Pence told Fox New Channel.

President Donald Trump has been pushing Congress to repeal and replace Obamacare, which would fulfill one of his top campaign promises from last year.

The current bill would take money that the federal government now spends on healthcare through the Medicaid insurance program for the poor and subsidies to help Americans buy private insurance and distribute it to the states in block grants.

The non-partisan Congressional Budget Office has not yet assessed the bill’s effects but independent analyses indicate it would fundamentally redistribute federal healthcare money, generally with Republican-leaning states benefiting and Democratic-leaning states losing.

The nonprofit Kaiser Family Foundation, a healthcare research group, estimated on Thursday that states that expanded Medicaid under Obamacare would lose $ 180 billion under the bill from 2020 to 2026, while non-expansion states would gain $ 73 billion in the same time period.

The Graham-Cassidy bill in 2020 would end the Obamacare Medicaid expansion, which many Democratic-governed states had carried out while many Republican-governed states did not, and limit overall federal spending on the five-decade-old program regardless of how many Americans qualify for its benefits.

Republicans have called Obamacare, formally known as the Affordable Care Act, a federal overreach, and say block grants would give states discretion on how to provide healthcare coverage.


According to the Kaiser Family Foundation analysis, five states would stand to lose more than 30 percent of their federal healthcare money from 2020-2026: New York (down 35 percent), Oregon (down 32 percent), Connecticut (down 31 percent), Vermont (down 31 percent) and Minnesota (down 30 percent). All are Democratic leaning.

The analysis found that six Republican-leaning states would get at least 40 percent more in federal funds: Mississippi (up 148 percent), Texas (up 75 percent), Kansas (up 61 percent), Georgia (up 46 percent), South Dakota (up 45 percent) and Tennessee (up 44 percent).

In total dollars, the state with the largest forecast loss of funds is California, losing $ 56 billion. The biggest gainer would be Texas, with a $ 34 billion increase. California, the most populous U.S. state, is Democratic leaning. Texas is the second most populous state and the largest Republican-leaning one.

“It’s absolutely true to say the Graham-Cassidy bill over time levels out on a per-person basis the way we distribute money on healthcare, which I think resonates with most Americans,” Pence said.

McCain, Collins and Murkowski were the three Republicans who voted against the last Republican healthcare legislation brought up in the Senate, which failed 51-49 in July. Paul, who voted in favor of that bill after previously expressing misgivings, on Thursday went to Twitter to underscore his criticism that the Graham-Cassidy bill does not go far enough to erase Obamacare.

The insurance industry, hospitals, medical advocacy groups such as the American Medical Association, American Heart Association and American Cancer Society, the AARP advocacy group for the elderly and consumer activists have come out against the bill, urging a bipartisan fix to the current law that was abandoned this week.

More medical and civil rights advocacy groups lined up against the Graham-Cassidy bill on Thursday, including the American Psychological Association, the American Congress of Obstetricians and Gynecologists and the NAACP.

The Center on Budget and Policy Priorities, a liberal think tank, estimated that the bill would cause more than 30 million people to lose insurance.

The Graham-Cassidy proposal would let states opt out of the requirement that insurers charge sick and healthy people the same rates, causing a furor among advocacy groups that say it could make health insurance unaffordable for those with pre-existing conditions.

Reporting by Susan Heavey and Yasmeen Abutaleb; Additional reporting by Doina Chiacu; Editing by Bill Trott

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Undetected fractures linked to back pain in older men

(Reuters Health) – About three in five older men with tiny spinal fractures related to osteoporosis reported new or worsening back pain in a new study.

Only about one-quarter of new vertebral fractures are diagnosed by a doctor, the study team writes in Journal of Bone and Mineral Research, though they may be a source of unexplained back pain.

Preventing these fractures could reduce back pain and related disability in older men, the authors conclude.

“Even when spine fractures are not recognized or diagnosed by a clinician, they still may cause new or worsening back pain and disability in some patients,” lead author Dr. Howard Fink, a researcher at the Veterans Affairs Health Center in Minneapolis, told Reuters Health by email.

Vertebral fractures are a common problem in older adults with osteoporosis, or weakening of the bones. However, most research has been done on older women, and the current study is the first of its kind to focus on older men, the study team notes.

The researchers examined data from about 4,400 men who were over age 65 when they enrolled in the Osteoporotic Fractures in Men study between 2000 and 2002. The men lived in one of six cities: Minneapolis, Pittsburgh, Portland, San Diego, Birmingham, Alabama and Palo Alto, California.

Each participant filled out back-pain symptom questionnaires at the beginning of the study and again about four and a half years later. In addition, each man had X-rays of the middle and lower back at the start, and again at the follow-up.

A total of 28 men were diagnosed with vertebral fractures by their own physicians during the follow-up. However, X-rays taken at the end of the study period showed an additional 169 men had new vertebral fractures that had not been diagnosed.

The study team found that 70 percent of men with undiagnosed vertebral fractures reported back pain compared to 59 percent of men with no vertebral fractures. About 93 percent of the men who had their fractures diagnosed during the study also reported back pain.

“Back pain is the most common symptom (of vertebral fractures),” Fink said.

It may be important to note the men in the study who had the undetected fractures tended to be older, have poorer health status and often had a history of vertebral fractures.

“This study demonstrates similar findings to that in elderly women, albeit at a lower prevalence. This is consistent with findings that men have a lower prevalence of osteoporosis than elderly women,” Dr. Aaron Buckland, director of research at New York University Langone’s Spine Center in New York City, told Reuters Health in an email.

Many factors may cause osteoporosis, some of which are modifiable, noted Buckland, who wasn’t involved in the study.

“Dietary intake of calcium and vitamin D and exposure to sunlight are important in maintaining bone mineral density. Regular weight-bearing exercises also help in maintaining bone mineral density,” he said.

Medical management of common endocrine conditions such as thyroid, adrenal or pituitary dysfunction as well as hypogonadism are other important factors in the elderly population to prevent secondary osteoporosis, Buckland said.

Avoidance of osteoporotic fractures, including vertebral and hip fractures, “is an important preventative management goal in patients with osteoporosis,” he said.

Although back pain is the primary symptom of a vertebral fracture, most back pain is due to something else, Buckland added. Most episodes of back pain are muscular in nature and last for less than six weeks and normally respond well to over the counter anti-inflammatory medicines and core strengthening exercises, he said.

“If you are experiencing persistent back pain for more than 6 weeks, or have associated weakness, numbness, bladder or bowel disturbance, or when pain is not adequately controlled, this is when you should seek medical evaluation and imaging,” Buckland said.

SOURCE: bit.ly/2y9rMiZ Journal of Bone and Mineral Research, online September 7, 2017.

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U.S. safety board: Train-crash engineers had sleep disorders

WASHINGTON (Reuters) – The engineers in two New York City area commuter train crashes suffered from undiagnosed sleep disorders, the U.S. National Transportation Safety Board said on Thursday.

The board plans to hold a Feb. 6 meeting on the September 2016 crash in Hoboken, New Jersey, that killed one person and injured more than 100 others, and the January accident in Brooklyn that left more than 100 people with non-life-threatening injuries.

Both engineers had no memory of the crashes and were severely overweight. The Centers for Disease Control says being overweight puts individuals at a higher risk of sleep apnea.

The disorder, characterized by shallow or interrupted breathing during sleep, often goes undiagnosed and can leave sufferers fatigued during the day, according to the U.S. National Institutes of Health.

The safety board said the brakes were working on the New Jersey Transit train traveling at 8 miles (13 km) per hour 38 seconds before the crash. The train then accelerated to 21 mph at impact, twice the speed limit, and emergency brakes were applied one second before the crash.

FILE PHOTO: A man sleeps on a bench as people try to commute to New York at the Hoboken Terminal in New Jersey, U.S. July 10, 2017. REUTERS/Eduardo Munoz

The 48-year-old engineer underwent a home sleep study in October that concluded “he had severe sleep apnea.” A separate report found he was obese and had gained more than 90 pounds in the previous five years.

In January, the safety board said the Long Island Rail Road train that crashed into a bumper at the busy Atlantic Terminal in New York’s Brooklyn borough appeared to be traveling at more than twice the speed limit of 5 mph.

The engineer was diagnosed with severe obstructive sleep apnea after the crash, the board said on Thursday.

The LIRR began testing all of its 432 engineers for sleep apnea after the accident and told the board that 34 had been screened through May.

Eight of the 34 had screened positive and had been referred for more testing. One other engineer told the LIRR he had been diagnosed and was being treated for sleep apnea.

The safety board has raised the issue before. In 2014, it said the driver of a train that derailed in New York City, killing four passengers, had an undiagnosed sleep disorder at the time of the 2013 accident.

Reporting by David Shepardson; Editing by Lisa Von Ahn

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Many drug companies fail to conduct timely safety checks on medicines after FDA approval

(Reuters Health) – In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market.

A new analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done.

Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, and colleagues looked at federal records and found that among the 614 studies mandated in 2009 and 2010, 20 percent were never started and 9 percent have been delayed.

“When drugs are approved, the trials are usually small and short-term, and some side effects may not emerge until the post-marketing phase,” Woloshin told Reuters Health in a telephone interview. “The problem is, the faster you get them on the market, the more open questions there are” about their safety or the best dose.

In a response published in the Journal, the FDA said that by its tally, 88 percent of all postmarketing requirements – not just those mandated in 2009 and 2010 – “were progressing according to their original schedules” as of the 2015 fiscal year.

One of four drug companies contacted by Reuters Health provided evidence that the information about its post-approval registry reported by the Woloshin team is inaccurate.

With President Donald Trump vowing to further speed the FDA approval process, “Drug approval is likely to become increasingly rapid and rely on looser evidence standards,” the Woloshin team writes in its report. “It will be crucial to ensure that the important questions that are unanswered at the time of approval are resolved as quickly as possible, too.”

One example of missed deadlines is Indivior’s Suboxone, a combination of buprenorphine and naloxone used to treat opioid dependence. The FDA wanted to know if it caused a specific problem with the heart.

“The sponsor was given more than 1 year to submit the trial protocol and 5 years to complete the trial,” the study authors write. “Nevertheless, as of July 2017, the final protocol had apparently not been submitted.”

And when Novartis’ $ 72,000-a-year multiple sclerosis treatment Gilenya (fingolimod) was approved, the FDA told the company to test a lower daily dose.

“Sometimes a lower dose may be as effective, but have fewer side effects,” Woloshin explained.

Yet “more than 6 years after approval, the trial had not been completed because of recruitment difficulties despite the manufacturer reporting $ 2.8 billion in sales,” the researchers write.

The company released a statement to Reuters Health saying recruitment was slow because multiple sclerosis therapy has evolved. Results of the study are expected in the second half of next year.

One example cited by the researchers is being challenged. The case involves Victoza, Novo Nordisk’s widely-prescribed drug for type 2 diabetes. Animal tests showed it might cause thyroid cancer. The FDA ordered the company to create a 15-year registry to record cases of thyroid cancer among users. The deadline for submitting rules for running the registry was July 2010.

The Woloshin team contends that no protocol for the registry has been submitted and cites an FDA website showing the registry as “Delayed.”

But company spokesman Ken Inchausti supplied a link to the trial on the website clinicaltrials.gov showing that enrollment began in January 2012. He told Reuters Health in an email that 996 patients have been interviewed to date.

Woloshin and colleagues write that their data show 16 percent of the ongoing studies are on schedule.

“Although being on schedule is reassuring, we would argue that some FDA-specified schedules are too long,” they write. The team believes the FDA should set shorter deadlines and impose penalties when companies miss these deadlines.

“For example,” they write, “the schedule for a 1-year pediatric safety and efficacy study for Welchol (colesevelam), used to assess treatment effects on type 2 diabetes in children . . . allowed 6 years for completion; an additional 4-year extension was also granted.”

The drug is marketed in the U.S. by Daiichi Sankyo, Japan’s second largest pharmaceutical company.

In some cases, the FDA has simply dropped a requirement for a postapproval study without giving a reason. “Adding this information to its public postapproval database would increase transparency,” Woloshin’s team writes.

The FDA statement does not directly respond to the suggestions. “Over time, advances in science, changes in standards of care, and new clinical information can affect study feasibility, design requirements, and even the need for or the appropriateness of a study,” the agency said.

“The FDA tracks these circumstances carefully and works with manufacturers to ensure that the postmarketing requirement or commitment study provides the information needed for public health,” it added.

SOURCE: bit.ly/2xuCDqO The New England Journal of Medicine, online September 20, 2017.

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Republicans 'close' on healthcare's last chance: Pence

WASHINGTON (Reuters) – U.S. Vice President Mike Pence on Thursday urged fellow Republicans to get behind the party’s “last best chance” to repeal and replace Obamacare as congressional leaders scrambled to secure enough support ahead of a planned vote next week.

Pence, in an interview on Fox News, said Republicans were close to dismantling the 2010 healthcare law passed by former Democratic President Barack Obama.

“This may well be our last best chance to stop and turn around,” he said.

Republicans need 50 votes to pass their latest healthcare overhaul plan before a Sept. 30 deadline in the Senate, where they hold a 52-48 majority. Majority Leader Mitch McConnell intends to bring it to the Senate floor for a vote next week.

President Donald Trump, who has no major legislative wins since taking office in January and is eager to make good on a campaign promise, supports the measure, introduced by Senators Lindsey Graham and Bill Cassidy. (For a Factbox on the plan see)

With no Democratic support for the bill, Republicans remain a handful of votes short. Senator Rand Paul opposes it and at least five others are undecided: Susan Collins, Lisa Murkowski, Dan Sullivan, John McCain and Jerry Moran.

A number of governors – both Republicans and Democrats – oppose the plan, saying it would curb needed funds, impose an unknown system of coverage and strip coverage from vulnerable patients.

Health insurers, hospitals, healthcare industry groups and consumer advocates have also come out against it, instead urging a bipartisan fix to the current law.

Several Republicans defended the measure on Thursday, saying they must make good on their years-long campaign promise to undo Obamacare and that their alternative would empower states.

They pointed to current problems with Obamacare. Although Democrats have said they want to fix the current law, a number of Republican senators said the Graham-Cassidy plan is the only option now.

“This doesn’t fix everything with Obamacare,” Republican Senator Jeff Flake told MSNBC. “It can‘t. We’re going to have to do that with a bipartisan bill. This is the first step.”

Republican Senator Ron Johnson was asked on MSNBC if people would lose coverage or face rising premiums under the plan.

“There are no guarantees,” he said.

In July, a Senate vote on a repeal-and-replace bill ended in a stinging 49-51 defeat for Republicans as Collins, McCain and Murkowski voted against it.

Reporting by Susan Heavey and Doina Chiacu; Editing by Bill Trott

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Nestle to cut jobs at French skin health R&D center

ZURICH (Reuters) – Nestle plans to cut up to 450 jobs at a Galderma research and development center in southern France, the Swiss company said on Thursday, as it seeks to make the underperforming skin health business more efficient.

Galderma, which Nestle took over from its joint venture partner L‘Oreal in 2014, will cut as many as 450 of 550 jobs at its R&D center in Sophia Antipolis near Nice.

Vevey-based Nestle is under pressure to improve efficiency and shareholder returns after years of slowing growth and its new Chief Executive Mark Schneider is expected to unveil his strategic priorities at an investor event next week.

Skin treatments have been a major part of a push by the world’s largest food maker into higher-growth and more profitable health products to counter a slowdown in its traditional food businesses, which range from KitKat chocolate bars to Perrier water.

Last month Nestle said it would close a skin cream factory in Switzerland, with the potential loss of 190 jobs, and shift production elsewhere in response to a slowdown.

Prescription medicines are moving away from creams towards injections or products taken orally and this shift is being reflected in changes to R&D, a Nestle spokesman said.

Nestle wants to combine development of prescription medicines within a single research center, whose location has yet to be decided, where about 100 of the employees would be able to find a new job with some 300 people likely to leave.

Nestle plans to review the French site over the next 12 months to decide whether specific activities can be continued.

The company does not break out results for its skin health business separately, but said in July it had lower second-quarter sales volumes and pricing, hurt by a soft performance in China and pressure from generic versions of its medicines.

Reporting by Silke Koltrowitz and Angelika Gruber; editing by Alexander Smith

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Exclusive: Africa to get state-of-art HIV drugs for $75 a year

LONDON (Reuters) – Makers of generic AIDS drugs will start churning out millions of pills for Africa containing a state-of-the-art medicine widely used in rich countries, after securing a multi-million dollar guarantee that caps prices at just $ 75 per patient a year.

Global health experts hope the deal will help address two looming problems in the HIV epidemic – the rising threat of resistance developing to standard AIDS drugs, and the need for more investment in manufacturing capacity.

Bill Gates’ charitable foundation will guarantee minimum sales volumes of the new combination pills using dolutegravir, a so-called integrase inhibitor that avoids the drug resistance that often develops with older treatments.

In return the drugmakers, India-based Mylan Laboratories and Aurobindo Pharma, will agree the maximum price of about $ 75 per patient for a year’s supply – less than the list price for one day’s supply of a dolutegravir combination in the United States.

The agreement, which will make the treatment available to 92 poor countries, starting in Africa, will be formally announced during the United Nations General Assembly in New York on Thursday.

“We need to make that guarantee because (of) the fixed costs of everybody gearing up to make high volume,” Gates told Reuters in a telephone interview. “That just wasn’t going to happen unless we put forward a very substantial volume guarantee.”

The Bill & Melinda Gates Foundation’s pledge is a central plank of a new partnership – the largest of its kind in global health – that also includes the governments of South Africa and Kenya, the Clinton Health Access Initiative, and American, British and U.N. agencies.

Under the deal, Mylan and Aurobindo will ramp up availability of a new fixed-dose combination of tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD).

Health ministries and other public sector purchasers will be able to buy TLD from next year at the capped price. The agreement could potentially save them more than $ 1 billion in drug bills over the next six years, the partners estimate.

As well as improving treatment, the drug combination should also reduce the need for more expensive second- and third-line drugs.


Around 37 million people around the world are infected with HIV, according to the United Nations AIDS agency UNAIDS. Just over half of them – about 19.5 million patients – get antiretroviral therapy medicines to keep their disease in check.

That represents remarkable progress in the past 20 years, driven by the availability of a first wave of cheap generic drugs from Indian companies. But rising levels of drug resistance are now a growing concern, while low prices have cut the incentive for investment in generic drug-making capacity.

In six out of 11 countries surveyed recently in Africa, Asia and Latin America, researchers found that more than 10 percent of HIV patients starting antiretroviral drugs had a strain of HIV resistant to the most widely-used medicines.

Once the 10 percent threshold is reached, best practice calls for switching to different drug regimens.

Dolutegravir is already being used on a limited basis as a single drug in Kenya, Nigeria, and Uganda.

The drug was originally developed by ViiV Healthcare, the HIV business majority-owned by GlaxoSmithKline. ViiV has offered licensing deals to generic companies to sell low-cost versions of the medicine in poor countries.

Clinical trials have shown that treatment regimens including dolutegravir work faster, have fewer side effects and demonstrate greater potency against drug resistance than standard HIV drugs used in Africa and other poor countries.

The TLD combination pill developed by Mylan and Aurobindo has already received tentative approval from the U.S. Food and Drug Administration under the President’s Emergency Plan for AIDS Relief program.

In Western markets, makers of patented AIDS drugs, such as GSK and arch-rival Gilead Sciences, notch up billions of dollars of highly profitable sales each year.

But the picture is very different for low-price generic companies in India, which have very low margins.

“The market is always on the edge where these guys don’t make enough money to stay in the business,” said Gates.

With the HIV-positive population still growing – there were an estimated 1.8 million new cases of infection in 2016 – the number of patients needing treatment is steadily increasing.

Industry experts like Johnson & Johnson Chief Scientific Officer Paul Stoffels question the feasibility of maintaining lifelong treatment for a patient population that could reach 50 million.

“The people who are infected today will need therapy for the next 30 to 50 years, so the science of treatment has to evolve and the science of prevention has to evolve as well to stop the pool of patients growing,” he told Reuters in a recent interview.

Editing by Pravin Char

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