Thursday, April 25, 2013

First vaccine to help control some autism symptoms

Apr. 24, 2013 ? A first-ever vaccine created by University of Guelph researchers for gut bacteria common in autistic children may also help control some autism symptoms.

The groundbreaking study by Brittany Pequegnat and Guelph chemistry professor Mario Monteiro appears this month in the journal Vaccine.

They developed a carbohydrate-based vaccine against the gut bug Clostridium bolteae.

C. bolteae is known to play a role in gastrointestinal disorders, and it often shows up in higher numbers in the GI tracts of autistic children than in those of healthy kids.

More than 90 per cent of children with autism spectrum disorders suffer from chronic, severe gastrointestinal symptoms. Of those, about 75 per cent suffer from diarrhea, according to current literature.

"Little is known about the factors that predispose autistic children to C. bolteae," said Monteiro. Although most infections are handled by some antibiotics, he said, a vaccine would improve current treatment.

"This is the first vaccine designed to control constipation and diarrhea caused by C. bolteae and perhaps control autism-related symptoms associated with this microbe," he said.

Autism cases have increased almost sixfold over the past 20 years, and scientists don't know why. Although many experts point to environmental factors, others have focused on the human gut.

Some researchers believe toxins and/or metabolites produced by gut bacteria, including C. bolteae, may be associated with symptoms and severity of autism, especially regressive autism.

Pequegnat, a master's student, and Monteiro used bacteria grown by Mike Toh, a Guelph PhD student in the lab of microbiology professor Emma Allen-Vercoe.

The new anti- C. bolteae vaccine targets the specific complex polysaccharides, or carbohydrates, on the surface of the bug.

The vaccine effectively raised C. bolteae-specific antibodies in rabbits. Doctors could also use the vaccine-induced antibodies to quickly detect the bug in a clinical setting, said Monteiro.

The vaccine might take more than 10 years to work through preclinical and human trials, and it may take even longer before a drug is ready for market, Monteiro said.

"But this is a significant first step in the design of a multivalent vaccine against several autism-related gut bacteria," he said.

Monteiro has studied sugar-based vaccines for two other gastric pathogens: Campylobacter jejuni, which causes travellers' diarrhea; and Clostridium difficile, which causes antibiotic-associated diarrhea.

The research was supported by the Natural Sciences and Engineering Research Council.

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Story Source:

The above story is reprinted from materials provided by University of Guelph.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.


Journal Reference:

  1. Brittany Pequegnat, Martin Sagermann, Moez Valliani, Michael Toh, Herbert Chow, Emma Allen-Vercoe, Mario A. Monteiro. A vaccine and diagnostic target for Clostridium bolteae, an autism-associated bacterium. Vaccine, 2013; DOI: 10.1016/j.vaccine.2013.04.018

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Source: http://feeds.sciencedaily.com/~r/sciencedaily/top_news/top_science/~3/0W9_AFl8Wv4/130424112309.htm

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Wines, spirits tax hike to wipe out benefits for pubs, bars: WSTA ...

Wines, spirits tax hike to wipe out benefits for pubs, bars: WSTA
Drinks Business Review
The increase in wines and spirits tax is set to wipe out the benefits of pubs and bars from the beer tax cut and affect women, who prefer wines and spirits over beer, according to a new analysis by UK-based organization for the wine and spirit industry ?

Simon

... is the owner of The Cyberboozer - a huge directory of pubs and bars, covering 93,000 pubs in 17 countries. He also likes to blog about news, products and pretty much anything else he can think of that's even loosely related to pubs and bars.

More Posts - Website - Twitter - Facebook

Filed under: News ? Tags: bars, benefits, Business, Drinks, hike, pubs, Review, spirits, wines, wipe, WSTA

Source: http://www.cyberboozer.com/pubsandbarsblog/news/wines-spirits-tax-hike-to-wipe-out-benefits-for-pubs-bars-wsta-drinks-business-review

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Seminar focus: The role of parents as coaches | The Salt Lake Tribune

Park City ? Speaker and athletes to talk about nurturing young athletes.

A free seminar on a parent?s role as a coach "on the field or in the backyard" will be presented 6:30 p.m. Tuesday, April 30, at Jim Santy Auditorium, 1255 Park Ave., in Park City.

Finn Gundersen, a consultant specializing in the development of high-performance athletes and sports education, will speak on the subject then lead a panel discussion involving prominent Olympic and professional athletes.

Gundersen believes the ultimate goal of playing sports is to help develop character and integrity in children, and that parents can best advance those life skills by helping ensure children?s experiences are positive. He will provide current research on how children learn new skills and information about how to promote long-term development and how to make players want to come back every year.

Panelists include former Olympic soccer player and Real Salt Lake assistant coach Miles Joseph and former Major League Baseball pitcher Mike Morgan and four Olympic gold medalists ? moguls racer Shannon Bahrke, Nordic combined skier/jumper Bill Demong and speedskaters Eric Heiden and Derek Parra.

Gundersen is director of sport education at High Performance Sports, research arm for the Philadelphia Union of Major League Soccer. He previously was a coach and director of Alpine and sport education for the Park City-based U.S. Ski and Snowboard Association, deputy general manager of Snowbasin?s Alpine skiing venue during the 2002 Winter Olympics and headmaster at Burke Mountain Academy in Vermont.

The seminar is sponsored by the nonprofit Park City Sports and Wellness Coalition, whose members include the Utah Olympic Legacy Foundation, Park City Recreation, Summit County and the Youth Winter Sports Alliance.


Copyright 2013 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Source: http://www.sltrib.com/sltrib/news/56166974-78/http-park-sports-gundersen.html.csp

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Health insurer WellPoint's 1Q profit rises 3 pct

INDIANAPOLIS (AP) ? WellPoint shares hit their highest level since the summer of 2011 on Wednesday after the nation's second largest health insurer trumped first-quarter earnings expectations, raised its 2013 forecast and said it could profit immediately from a key health care overhaul coverage expansion next year.

The Indianapolis company's performance to start 2013 followed a year marked by slumping earnings, a forecast cut and the abrupt departure of former CEO Angela Braly. Analysts say the net income and higher forecast WellPoint reported Wednesday helped improve investor sentiment.

"We believe this turnaround story is making progress," BMO Capital Markets analyst Jennifer Lynch said in a research note.

Stifel Nicolaus analyst Thomas Carroll added that investors came into the quarter with relatively low expectations for the Blue Cross Blue Shield insurer, and left happy to see some upside in the stock.

WellPoint Inc.'s first-quarter earnings rose about 3 percent to $885.2 million, or $2.89 per share. That compares to $856.5 million, or $2.53 per share, a year ago. Adjusted earnings totaled $2.94 per share, not counting investment gains.

That easily topped the average analyst forecast of $2.38 per share, according to FactSet.

Operating revenue, which also excludes investment results, jumped nearly 16 percent to $17.55 billion. Analysts expected higher revenue of $17.86 billion.

WellPoint said its acquisition last year of Medicaid coverage provider Amerigroup Corp. helped revenue spike and added more than 2 million members to its enrollment in the first quarter. That helped raise the insurer's total membership to 35.8 million people, a total that trails only UnitedHealth Group Inc.

Medicaid is the state-federal program that provides health coverage for the needy and disabled people, and it represents a growth opportunity for health insurers. States are starting to move residents who qualify for both Medicaid and Medicare, which is a federally-funded program for people over age 65 and the disabled, into managed care programs that improve care and cut wasteful spending.

WellPoint officials have said the opportunity these "dual eligible" patients offer was a driving force behind the deal. Medicaid enrollment also will grow next year in several states when the program expands as part of the health care overhaul's push to cover millions of uninsured people.

WellPoint Chief Financial Officer Wayne DeVeydt said Wednesday the insurer's new Medicaid patients from the overhaul expansion could become profitable immediately. He said the Amerigroup acquisition means the insurer is already set up in several states where coverage will expand.

These contracts usually take a year to break even and become profitable, said Ana Gupte, an analyst for the investment research firm Dowling & Partners.

States hire insurers to administer their Medicaid coverage, and the companies face high expenses initially as they set up doctor networks and learn what sort of programs their new patient population needs. For instance, a population with a high concentration of diabetes patients may need support programs to help people manage their disease.

While instant profitability from the Medicaid expansion represents a positive, WellPoint still faces plenty of uncertainty over how the overhaul will affect it next year, Wells Fargo analyst Peter Costa said.

WellPoint has a relatively large percentage of its enrollment in individual insurance or coverage through small businesses. The overhaul calls for exchanges to start next year on which people in those markets will be able to buy coverage, many with help from income-based tax credits. Investors aren't sure how much business insurers like WellPoint will lose or gain because of these exchanges, and analysts say that has made them wary of buying the stock.

That wasn't the case at least on Wednesday, when the stock climbed 5.8 percent, or $4 to close at $73.33 after touching a high price of $74.43 earlier in the session. FactSet says that is its highest price since July 2011. The stock is up nearly 20 percent so far this year.

Angela Braly, the former CEO, left last August as investor frustration started to surface over the company's performance. WellPoint has since beaten analyst expectations for three straight quarters, and new CEO Joseph Swedish started last month.

On Wednesday, WellPoint said it now expects 2013 earnings to total $7.80 per share, up from its forecast in January for $7.60 per share. Analysts expect, on average, earnings of $7.82 per share.

Source: http://news.yahoo.com/health-insurer-wellpoints-1q-profit-rises-3-pct-103538832--finance.html

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Wednesday, April 24, 2013

U.S. sues Novartis, alleging kickbacks to pharmacies

By Bernard Vaughan and Jonathan Stempel

(Reuters) - The U.S. government filed a civil fraud lawsuit against Novartis AG on Tuesday, accusing a unit of the Swiss drug maker of causing the Medicare and Medicaid programs to pay tens of millions of dollars in reimbursements based on fraudulent, kickback-tainted claims.

U.S. Attorney Preet Bharara in Manhattan said Novartis Pharmaceuticals Corp had since 2005 induced at least 20 pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic from competitors' drugs, in exchange for kickbacks disguised as rebates and discounts.

He said Novartis tried to conceal the scheme by omitting the agreements from rebate and discount contracts with pharmacies.

In one alleged case, Novartis offered a Los Angeles pharmacist a "bonus" rebate of 5 percent of that pharmacist's annual Myfortic sales, or several hundred thousand dollars, to switch as many as 1,000 patients to Myfortic.

"Novartis co-opted the independence of certain pharmacists and turned them into salespeople," Bharara said in a statement.

The lawsuit was filed in U.S. District Court in Manhattan, and seeks civil penalties and triple damages from Novartis for violating the federal False Claims Act.

Novartis disputes the claims and will defend itself, spokeswoman Julie Masow said in an email.

Novartis is "committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Masow said.

Myfortic net sales totaled $579 million in 2012, up 12 percent from a year earlier, according to Novartis' annual report. The Novartis Pharmaceuticals unit has offices in East Hanover, New Jersey.

In his announcement, Bharara called Novartis a "repeat offender," referring to a settlement of health care fraud charges based on kickbacks less than three years ago.

Novartis in September of 2010 agreed to pay $422.5 million to resolve criminal and civil liability over its marketing of several drugs, including the epilepsy drug Trileptal. (http://www.justice.gov/opa/pr/2010/September/10-civ-1102.html)

The company violated a federal anti-kickback statute, "choosing instead to put sales growth and profits before its duty to comply with federal law," according to the new complaint.

The federal anti-kickback statute prohibits paying people to buy drugs or services that Medicare, Medicaid or other federal healthcare programs cover, according to the complaint.

The scheme has been highly lucrative for Novartis, according to the complaint, resulting in "rapid, sometimes exponential growth in Myfortic sales."

A pharmacy in Arkansas, for example, increased its annual sales of the drug to more than $1 million from $100,000 over four years, according to the complaint.

The lawsuit also claims a Novartis account manager admitted the kickback scheme generates "an ongoing stream of revenue" for Novartis "as long as the patient is still living and using (Myfortic)."

These types of cases "are one of the highest priorities of the FBI's health care fraud program," FBI Assistant Director Ronald Hosko said in a statement.

The case is U.S. v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-08196.

(Reporting by Jonathan Stempel and Bernard Vaughan in New York; Editing by Gary Hill, David Gregorio and Tim Dobbyn)

Source: http://news.yahoo.com/u-sues-novartis-alleging-kickbacks-pharmacies-010252156--finance.html

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Texas Instruments Q1 2013 results: $362 million in income on $2.89 billion revenue

Texas Instruments

Smart phone and tablet products officially winding down, revenues expected to decline appropriately

Texas Instruments is reporting its Q1 2013 earnings today, and the overall numbers are looking quite good. Although revenue for the quarter was down slightly, TI has posted net income and EPS that were near the top of their expected range. Here's a quick breakdown of the high points:

  • $2.89 billion in revenues, down 8-percent year-over-year
  • $362 million in net income, up 37-percent y-o-y
  • $0.32 Earnings Per Share, up 45-percent y-o-y
  • $3.9 billion in cash and short-term investments on hand

If it wasn't clear last year that TI is shifting away from the business of consumer chipset products, it should be after reading this earnings release. On its segmented earnings, TI has officially pushed its wireless business -- now dubbed "legacy wireless products" -- into the "Other" category of the sheet, which should give you an indication of where it is headed. Looking forward for Q2 2013 and beyond, TI is advising that its revenues will continue to decline in the legacy wireless business.

TI now says that a full 77-percent of its revenues come from "Analog and Embedded Processing", which means products aimed at the consumer space are far from the priority now. Aside from a cheap alternative to the more popular processors out there right now, don't look for OMAP processors to be making their way into too many products in the coming months.

Source: Texas Instruments

    


Source: http://feedproxy.google.com/~r/androidcentral/~3/bH3JiJ25YIc/story01.htm

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Motherlode Blog: Study Links Autism With Antidepressant Use During Pregnancy

A cautiously worded study based on data collected in Sweden has found that ?in utero exposure to both selective serotonin reuptake inhibitors (S.S.R.I.?s) and nonselective monoamine reuptake inhibitors (tricyclic antidepressants) was associated with an increased risk of autism spectrum disorders, particularly without intellectual disability.?

The Swedish medical birth register (which contains data on current drug use reported by mothers early in their pregnancies), along with a system of publicly funded screenings for autism spectrum disorders and extensive national and regional registers of various health issues, make a detailed, population-based case-control study possible ? one that controls for other variables like family income, parent educational level, maternal and paternal age and even maternal region of birth (all factors the authors note have been previously associated with autism).

This is the second study in two years to associate antidepressant use during pregnancy with an increased incidence of autism in exposed children. An earlier, smaller study in California also found a modest increase in risk. The Sweden-based study could not (and did not) exclude the possibility that it was the severe depression, rather than the use of antidepressants, that created the association, but the smaller California study (which considered only S.S.R.I.?s) found ?no increase in risk? for mothers with a history of mental health treatment in the absence of prenatal exposure to S.S.R.I.?s.

The authors of the current study took a very cautious approach to their findings:

The results of the present study as well as the U.S. study present a major dilemma in relation to clinical advice to pregnant women with depression. If antidepressants increase the risk of autism spectrum disorder, it would be reasonable to warn women about this possibility. However, if the association actually reflects the risk of autism spectrum disorder related to the nongenetic effects of severe depression during pregnancy, treatment may reduce the risk. Informed decisions would also need to consider weighing the wider risks of untreated depression with the other adverse outcomes related to antidepressant use. With the current evidence, if the potential risk of autism were a consideration in the decision-making process, it may be reasonable to think about, wherever appropriate, nondrug approaches such as psychological treatments. However, their timely availability to pregnant women will need to be enhanced.

Others working in the field are more inclined to draw a line between the prenatal drug exposure and the increased risk of autism. ?It really shouldn?t come as that much of a surprise given that numerous animal studies have shown that exposure during development leads to changes in the brain and changes in behavior ? often that mimic autism,? said Dr. Adam C. Urato, assistant professor of obstetrics and gynecology at the Tufts University School of Medicine and chairman of the department of obstetrics and gynecology at MetroWest Medical Center in Framingham, Mass. (Dr. Urato obviously didn?t speak in links, but you can find the animal studies he refers to here and here.)

?And why should it surprise us that medications that can change brain chemistry and function might alter the development of the brain and behavior?? Dr. Urato argues that the risks of antidepressant use during pregnancy outweigh what he sees as the limited benefits.

One conclusion that is simple to draw is that it?s extraordinarily difficult for a pregnant woman with clinical depression to find some definitive answer about what?s best for her in her situation. I?ve spoken to other researchers in the past who have described for me how difficult it is to put together a study that separates the risks of depression itself in pregnancy from the risks, if any, of the drugs used to treat it. As the researchers in Sweden note, it?s unlikely that conclusive evidence on this issue will ever be available.

If you?ve been pregnant with clinical depression, where did you go to find the information and advice you needed?


Source: http://parenting.blogs.nytimes.com/2013/04/22/study-links-autism-with-antidepressant-use-during-pregnancy/?partner=rss&emc=rss

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