Man dies from West Nile virus in Manitoba

Man dies from West Nile virus in Manitoba

A man in his 80s has died as a result of West Nile virus in Manitoba.

It is the first death reported since January 2008 and the eighth death since the province began collecting information on the virus, according to Manitoba Health.

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The man, a resident of the Interlake-Eastern Health Region, had West Nile virus neurological syndrome, a rare but more serious condit ion caused by the virus, Manitoba Health stated in a news release.

It is believed he was exposed to the virus in that health region during the first half of August.

The province is not being more specific about the area or releasing any more information on the man in order to protect his privacy.

Human cases of West Nile virus were first reported in Manitoba in 2003.

The province previously reported this year's first human case of infection on Aug. 22, involving a woman in her 40s who experienced mild symptoms.

Dr. Margaret Fast is the medical officer of health for Manitoba.

She said the risk of being exposed to the virus is low at this time of year, but it isn’t eliminated.

“There are still some culex tarsalis out there, but they are at the end of their biting season as well, though,” she said. “We are at the tail end of the season, but we are still advising people to take precautions.”

With shorter days and cooler temperatures, mosquitoes are more likely to bite late in the afternoon and early in the evening.

Fast said some people will only experience symptoms days after being exposed.

“You may develop some fever and maybe a bit of nausea, maybe you just feel unwell and under the weather,” she said, adding it could feel similar a flu-like illness.

The province is advising people to cover up and use insect repellent when outdoors to protect themselves.

There will continue to be a risk of exposure to the virus until the weather becomes colder or until the first hard frost.

First lady: Water increases energy

First lady: Water increases energy

The nation’s most prominent anti-obesity crusader, first lady Michelle Obama, has turned her attention to beverages and is encouraging Americans to drink more water.

Mrs. Obama’s “Drink Up” campaign was unveiled Thursday at an event in Watertown, Wis. â€" a town where, ironically, the soda industry is a key cog in the economy.

While the soft drink industry has endorsed the effort, it’s coming under fire from other quarters, most notably some in medicine who believe it is overselling the virtues of H20.

Few dispute water’s overall health benefits, but questions surround whether the first lady and others have gone too far by suggesting, among other things, that increased water consumption leads to increased energy.

“It’s not a very scientific approach they’ve taken The idea drinking water increases energy, the word I’ve used to describe it is quixotic,” Stanley Goldfar b, a professor of medicine at the University of Pennsylvania, told Politico on Thursday, one of several specialists puzzled by the new effort.

The “Drink Up” initiative has a very narrow aim. Proponents â€" including actress Eva Longoria, who joined Mrs. Obama in Watertown on Thursday â€" aren’t recommending a specific amount of water each day, nor are they explicitly asking Americans to use it as a substitute for soda, beer and other drinks.

Instead, the campaign simply wants everyone to drink one more glass of water every 24 hours, regardless of how much or how little one already consumes each day.

“It doesn’t matter where you get it from â€" the tap, a water bottle, a water fountain â€" just drink one more glass of water a day,” Mrs. Obama said Thursday, addressing a crowd of Watertown High School students. The town was chosen not only because of its undeniably fitting name, but also because it’s been recognized by the American Water Associ ation as having the cleanest water in Wisconsin.

“If we all do this, if we all drink up, we’ll all feel better,” Mrs. Obama continued. “We’ll all have more energy, we will have more focused students, we will have more productive workplaces and we will have vibrant neighborhoods and a healthier country. In the end, that’s what it’s all about.”

Before Mrs. Obama spoke, she apparently had to assure local officials she wouldn’t bad-mouth the soda industry, public enemy No. 1 in the first lady’s ongoing anti-obesity campaigns and efforts to get healthier food and drink into school cafeterias.

Watertown is home to Wis-Pak, a leading manufacturer and distributor of soft drinks, and Mayor John David admitted he initially feared Mrs. Obama would come to town and take soda to task.

“That was a concern. I have been assured on different occasions that there is no soda-bashing here,” he told Milwaukee’s Fox 6 TV station.

In fact, th e American Beverage Association on Thursday voiced strong support for the effort, pointing out that its companies are the ones producing bottled water.

“Staying hydrated is important to staying in balance, and bottled water provides people with a convenient and popular choice,” said Susan Neely, the association’s president and CEO. “By supporting this new initiative, our industry is once again leading with meaningful ways to achieve a balanced lifestyle.”

Stem cells generated in live mice

Stem cells generated in live mice

Featured Article
Academic Journal
Main Category: Stem Cell Research
Also Included In: Biology / Biochemistry
Article Date: 12 Sep 2013 - 8:00 PDT

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A team of scientists in Spain has reprogrammed adult cells in live mice to revert to stem cells that appear as potent as embryonic stem cells.

The team reports its findings online this week in the journal Nature. The study is the first to achieve in living tissue what so far has only been possible in a petri dish.

Embryonic stem cells represent the "gold standard" in stem cell research and regenerative medicine, since they are the only stem cells capable of differentiating into any of the hundreds of cell types in the body.

The hope is that harnessing this ability to differentiate into any cell type will lead to treatments that can cure diseases like Alzheimer's, Parkinson's and diabetes.

However, there are ethical problems about sourcing embryonic stem cells, as well as practical difficulties, since they have a very short lifespan during the early development of the embryo.

Thus, there is a need to find alternative ways to make stem cells that are as good as embryonic stem cells.

One possibility that has been hotly pursued is to try and "reverse engineer" adult cells - that is, cells that once used to be stem cells but have fully differentiated into a particular type of cell - back to their undifferentiated, primitive state.

In 2006, a Japanese team led by Shinya Yamanaka showed it was possible, in cell culture using just four genes, to reprogram adult cells to behave almost like embryonic stem cells. They named the cells induced pluripotent stem cells (iPSCs).

Yamanaka was awarded the Nobel Prize in Medicine in 2012 in recognition of the importance of this work to regenerative medicine.

"Totipotent" stem cells generated without petri dish

In this latest study, scientists led by Dr. Manuel Serrano, a cancer researcher at the Spanish National Cancer Research Centre (CNIO), managed to generate directly in live mice what Yamanaka and colleagues achieved, but without the need to pass through the petri dish stage.

The team also found the stem cells they generated were even more like embryonic stem cells than those made using cultured cells. They say their cells' ability to differentiate is more than pluripotent, it is "totipotent," a primitive state that has never before been generated in the lab.

They say the state of undifferentiation they achieved in the totipotent stem cells is equivalent to that found in human embryos at the 72-hour stage of development, when they comprise only 16 cells.

This represents a much earlier embryonic state than that shown by iPSCs, with greater capacity for differentiation, and potentially placing the totipotent stem cells closer to the gold standard.

Regenerating tissue in place of damaged tissue

Researchers managed to manipulate cells in live mice by activating four genes, resulting in embryonic stem cells in adult tissues and organs.

The team believes the achievement brings the potential to use stem cell technology in regenerative medicine a step closer.

They managed to genetically manipulate adult cells in living mice by activating the four genes from the Yamanaka experiment and make the cells regress to an earlier evolutionary state. In effect, the cells became embryonic stem cells in multiple adult tissues and organs.

This has never been seen before in nature, says lead author María Abad.

Dr. Serrano, who is director of the Molecular Oncology Program and head of the Tumoral Suppression Laboratory at CNIO, adds:

"We can now start to think about methods for inducing regeneration locally and in a transitory manner for a particular damaged tissue."

Totipotent stem cells are more versatile

The totipotent stem cells even produced (in the chest and abdominal cavities of the mice) tissue structures that occur in the early stages of a new embryo.

These included the three types of tissue (ectoderm, mesoderm and endoderm) that develop in embryos and external structures, like the Vitelline membrane, as well as early signs of blood cells.

Serrano says this suggests their stem cells are more versatile than iPSCs produced in the lab, "whose potency generates the different layers of the embryo but never tissues that sustain the development of a new embryo, like the placenta."

He and his colleagues were also able to make the stem cells survive outside of mice, in a culture. This makes it easier to manipulate them and carry out further experiments.

While the step they have taken is a huge one and sends regenerative medicine and tissue engineering research in a new direction, the researchers say they still have far to go before their stem cells are ready for any kind of clinical use.

They now plan to find out if their new stem cells can produce different tissue types, such as that of organs like the pancreas, liver and kidney.

The Spanish Ministry of Economy Competitiveness, the European Research Council, the Madrid regional government, and the AXA, Botín, and Ramón Areces Foundations funded the team's work.

In another paper published recently, scientists in China reported how they found a safe and easy way to make stem cells.

Written by Catharine Paddock PhD

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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• Citations

Reprogramming in vivo produces teratomas and iPS cells with totipotency features; María Abad, Lluc Mosteiro, Cristina Pantoja, Marta Cañamero, Teresa Rayon, Inmaculada Ors, Osvaldo Graña, Diego Megías, Orlando Domínguez, Dolores Martínez, Miguel Manzanares, Sagrario Ortega Manuel Serrano; Nature Published online 11 September 2013; DOI:10.1038/nature12586; Abstract.

Additional source: Spanish National Cancer Research Centre (CNIO) news release (pdf) 11 September 2013.

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Botox approval for crow's feet provides bit of upbeat news for beleaguered ...

Botox approval for crow's feet provides bit of upbeat news for beleaguered ...

Allergan ($AGN) has faced some tough news in recent months, so a new FDA approval for Botox provides something for execs to smile about, even if it is just for the cosmetic use on crow's feet.

The Irvine, CA-based company said that with the FDA approval, Botox Cosmetic is the first and only drug of its kind to temporarily treat moderate to severe lateral canthal lines, commonly known as "crow's feet" lines. When Allergan last year talked about seeking approval in this category, analysts predicted the market could add about $100 million in sales for the drug, which was approved in 2002 for cosmetic use on frown lines between the brows.

In June, Allergan was blindsided by FDA draft guidance that would allow generics of its eye drug Restasis onto the market without clinical testing, years ahead of what anyone expected. That put a huge damper on its shares because, at $792 million in sales last year, Restasis was Allergan's best-selling product. Trying desperately to hold onto that revenue stream as long as it can, the company last month asked the FDA to set a higher bar for approving generic versions by requiring testing in humans. The company is arguing that generic versions can't be deemed bioequivalent unless they're tested in patients and that the FDA's proposal to permit only lab testing is contrary to the agency's past position.

But that is only part of the bad news that has flooded the company this year. In April, the FDA refused to approve its new migraine drug because of manufacturing problems. And in August, Allergan lost two patents in India. India's patent appeals board revoked the patents covering glaucoma treatments Ganfort and Combigan, both used to reduce pressure inside the eye, following a patent challenge from domestic drugmaker Ajanta Pharma.

- here's the release

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FDA orders more stringent labeling for opioid drugs

FDA orders more stringent labeling for opioid drugs

Leaders of the Food and Drug Administration said they hoped new drug labeling guidelines unveiled Tuesday would prompt doctors to be more cautious in prescribing long-acting and extended-release forms of oxycodone, morphine and other narcotic painkillers, known as opioids.

Such drugs â€" sold as OxyContin, Opana and other brand names â€" account for less than 10% of all opioid prescriptions written in the U.S. More widely prescribed, fast-acting opioids, including hydrocodone, were not affected by the FDA action.

As a class, opioid painkillers have fueled a surge in prescription drug overdoses, which in 2009 surpassed traffic accidents as a leading cause of preventable deaths in the U.S. They are abused by more than 12 million people each day and contributed to 16,651 overdose deaths in 2010, according to the Centers for Disease Control and Prevention.

A Times analysis of nearly 4,000 prescription drug deaths in Southern California over a six-year period found that opioids and other drugs prescribed to victims played a role in nearly half the cases. Hydrocodone and oxycodone were among the drugs most frequently cited in these deaths.

The FDA will now require the manufacturers of 20 long-acting opioid products to rewrite the drugs' labels to reflect that they should be used more sparingly. Those labels should be revised by December.

Drug manufacturers will also have to conduct new research aimed at identifying what doses and modes of use are most likely to harm patients, said FDA Commissioner Margaret A. Hamburg.

Public health and addiction experts who have been pressing the FDA to help scale back the use of all forms of opioid painkillers said the agency didn't go nearly far enough. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said the group was considering taking the FDA to court to force it to impose tougher prescribing limits.

"This is just more hot air," said Kolodny, an addiction specialist in New York. "This makes it look like they are doing something. But they are continuing to allow opioid manufacturers to promote their products for conditions where the risks are likely to outweigh the benefits."

Lynn Webster, president of the American Academy of Pain Medicine, said those moves were a step in the right direction, particularly its call for drug makers to undertake safety and efficacy studies. But Webster said the action failed to address how well patients followed doctors' orders, a factor he views as a key driver of overdose deaths.

"People who are in severe pain often take more than is prescribed to them, so limiting the label indication is not going to prevent that from happening," said Webster, a pain medicine specialist and researcher in Salt Lake City. "To reduce the harm from opioids is going to take a lot more than a label change."

Sales of opioids have quadrupled over the last decade, buoyed by robust marketing and a movement to relieve pain. Overdose deaths involving painkillers also skyrocketed over the same period.

When opioids reach the brain, they bind to particular receptors that dampen the perception of pain. They can also induce a feeling of euphoria that can become addictive. When taken in large enough doses, the drugs have a sedative effect that can cause people to stop breathing, leading to death.

Currently, the labels on long-acting and extended-release opioid narcotics say they should be used for "moderate-to-severe" pain. The revisions will remove "moderate pain" from the agency's list of approved uses for the drugs, replacing it with "pain severe enough to require daily, around-the-clock, long-term opioid treatment" for which alternative treatments have failed.

Through labels, the FDA controls how drug makers may promote and market medications to physicians. Insurers use labels to help determine whether they will pay for a prescription. Those decisions, along with manufacturer marketing, influence doctors' prescribing decisions.

In requiring drug makers to rewrite labels, the FDA aims to change the current practice of prescribing these powerful analgesics for use by patients on an "as needed" basis. Although the guidelines won't place formal restrictions on prescribing by physicians who treat patients for pain, FDA leaders made clear they wanted to discourage physicians from prescribing the medications for anything other than ongoing, intractable pain.

Agency officials said they wanted to encourage patients and their physicians to focus not just on subjective levels of pain â€" such as "moderate" and "severe" â€" but on how long pain persists and on other treatment options.

"The goal here was to make every patient taking extended-release and long-acting opioids to have a conversation about whether these products are helping them as individuals," said Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. "I hope this encourages physicians and patients to be more thoughtful and more careful as they use these medications."

Doctors will still have broad latitude to prescribe the drugs "off-label" where they judge their use to be medically warranted.

Purdue Pharma, the manufacturer of OxyContin, and Endo Pharmaceuticals, which makes Opana, said they were studying the details of the FDA announcement to determine how to respond. Blaine Davis, a spokesman for Endo, said it was too early to know how the guidelines would affect marketing or prescribing.

The decision does not change the labels or prescribing guidelines of fast-acting opioid pain relievers, which are often prescribed to patients following surgery, an injury or dental work. FDA officials said they focused first on the long-acting and extended-release formulations because they posed a higher risk of abuse, addiction and overdose.

Officials also said they had seen a sharp increase in the number of babies who had been exposed to opioid painkillers in utero â€" a condition that can result in painful and potentially life-threatening withdrawal symptoms in the early days of life. The label changes ordered Tuesday also encourage physicians to discuss with women of childbearing age the potential dangers of opioid medications to an unborn child.

lisa.girion@latimes.com

melissa.healy@latimes.com

Girion reported from Los Angeles and Healy from Bethesda, Md.

FDA panel supports approval of Glaxo lung drug Anoro

FDA panel supports approval of Glaxo lung drug Anoro

By Toni Clarke

WASHINGTON | Tue Sep 10, 2013 3:43pm EDT

WASHINGTON (Reuters) - A federal advisory panel recommended approval of GlaxoSmithKline's new drug to treat chronic obstructive pulmonary disease (COPD), and suggested the company be required to conduct further safety studies afterwards.

The panel of expert advisers to the U.S. Food and Drug Administration voted 11-2 to approve the inhalant drug, Anoro, to help improve lung function in people with the disorder often associated with smoking.

Anoro is a combination of vilanterol, which is designed to open the airways, and umeclidinium, which works to improve lung function. GSK is developing the product with partner Theravance Inc.

The FDA is not required to follow the advice of its advisory panels but typically does so.

The drug is expected to generate sales of more than $2 billion a year by 2018, six analysts polled by Thomson Reuters estimated on average. A decision is expected by December 18.

Much of the panel's discussion centered on the drug's safety profile, particularly an imbalance in the number of non-fatal heart attacks seen in patients taking Anoro in shorter clinical trials compared with those taking a placebo.

A similar imbalance was not seen in a longer safety study, however, leaving many panel members scratching their heads and worried that the drug may increase the risk of cardiovascular problems in sicker patients.

Dr. James Stoller, chair of the Education Institute at the Cleveland Clinic, said the data left him with a "non-specific sense of unease" and he voted against the drug.

Even some of those who voted in favor of the drug did so with hesitation. Dr. David Jacoby, professor of medicine at Oregon Health and Science University, said he was "very borderline" on his decision and continues to have "serious concerns" about whether the drug will prove safe when used outside the confines of a clinical trial.

"I strongly support warnings in the labeling and a post-marketing study," he said.

The panel voted unanimously that the drug is effective.

COPD is the third-leading cause of death in the United States, according to federal data. The condition is often associated with smoking and can include emphysema, chronic bronchitis, or both.

Investment analysts had been expecting a positive recommendation.

In May, the FDA approved another drug for COPD made by the two companies called Breo. Breo is an inhaled combination of vilanterol and the corticosteroid fluticasone furoate, which reduces inflammation. That drug is expected to generate $1.9 billion by 2018.

(Reporting by Toni Clarke in Washington; Editing by Carol Bishopric and Richard Chang)

CDC: More than 200000 Americans quit smoking after graphic ad campaign

CDC: More than 200000 Americans quit smoking after graphic ad campaign

“The TIPS campaign surpassed our expectations,” CDC Director Thomas Frieden told reporters in a call Monday, saying the results represented more than a doubling of initial goals. “That’s a tremendous success story. These are Americans that will live longer lives, healthier lives with lower health-care costs.”

The $54 million ad series, which ended in June 2012, featured stark images and emotional pleas from ex-smokers suffering from a variety of ailments, including amputated limbs, oral and throat cancer, paralysis, lung damage, strokes, and heart attacks.

One of the most haunting ads featured a 52-year-old North Carolina woman named Terrie Hall, who had to have her larynx removed after being diagnosed with throat c ancer. She now speaks with the help of an artificial voice box.

“The only voice my grandson’s ever heard is this one,” she says in a robot-like voice in one commercial.

The CDC study, published in the medical journal the Lancet, surveyed a randomly selected group of about 3,000 smokers and 2,200 nonsmokers before and after the initial ad campaign. Almost 80 percent of smokers and nearly 75 percent of nonsmokers recalled seeing at least one of the ads during the campaign, the CDC found.

The agency also said that calls to its toll-free quit line (800-QUIT-NOW) more than doubled during the ad campaign, and visits to its Web site were five times greater than during the same three-month period a year earlier.

Officials said the campaign saved an estimated 300,000 years of life t hat otherwise would have been lost to smoking-related disease, which remains the leading cause of preventable death in the United States, killing more than 1,200 Americans each day.

“This study shows that we save a year of life for less than $200. That makes it one of the most cost-effective prevention efforts,” Tim McAfee, director of the CDC’s Office on Smoking and Health and lead author of the study, said in a statement Monday.

A second batch of TIPS ads aired in early 2013, and the agency plans to air another round in 2014.

“Bottom line: Ads against tobacco work,” Frieden said. “This campaign saved lives. . . . It also saves money.”