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TRENTON, N.J. (AP) -- Drugmaker Merck & Co. is joining two dozen other pharmaceutical companies and contract laboratories in committing to not use chimpanzees for research.

The growing trend could mean roughly 1,000 chimps in the U.S. used for research or warehoused for many years in laboratory cages could be "retired" to sanctuaries by around 2020.

That's according to Kathleen Conlee of the Humane Society of the United States, which seven years ago began urging companies to phase out all chimp research.

The trend is driven by improved technology, animal alternatives and pressure from animal rights groups, the National Institutes of Health and Congress.

Last June, reacting to an Institute of Medicine study Congress had requested that concluded nearly all chimp research is unnecessary, the NIH announced it would retire and send about 90 percent of government-owned research chimps to the Chimp Haven sanctuary in Keithville, La. It's now home to about 160 chimps, with nearly 60 more to arrive soon.

After several years, the NIH plans to decide whether the remaining chimps in government labs can also be moved to sanctuaries. Roughly 450 other chimps are owned by private labs that do research under contract for drugmakers and other companies.

"It's been a long road in trying to end the use of chimpanzees in research, and we're now at a turning point," Conlee told The Associated Press Thursday. "We're going to keep on (advocating) until the chimpanzees in laboratories are all in sanctuaries."

Merck spokeswoman Caroline Lappetito said the company, based in Whitehouse Station, N.J., decided late last year to stop research on chimpanzees and switch to alternative types of testing.

"The science has advanced, and we don't really need it," Lappetito said.

Merck, the world's third-biggest drugmaker, is the largest to make the switch.

Companies that develop medicines and consumer products such as cosmetics have long used animals to test safety and effectiveness. In the case of experimental medicines, drugmakers must test on animals before the Food and Drug Administration will let them do the human testing needed for approval of a new therapy.

Nearly all animal experiments in the U.S. involve mice, rats and guinea pigs, although some are done on dogs and great apes, almost always chimpanzees.

But animal research, particularly on primates and pet species such as dogs and rabbits, has long drawn criticism from animal rights groups, including protests outside laboratories and at annual shareholder meetings. Besides calling the practice inhumane, activists often have alleged - and sometimes proven - that animals were being abused.

Many companies previously said it was necessary to test potential medicines and vaccines on nonhuman primates because they needed an animal in which the anatomy and disease course were very similar to that in humans.

That thinking changed as technology allowed researchers to do initial testing via computer simulations, in bacteria or cells, and in animals as small as fish. Many drugmakers also found ways to do testing on far fewer animals and to limit the discomfort of experiments by using painkillers and tranquilizers. And many of the companies pledging not to use chimps in the future never did so.

British drugmaker GlaxoSmithKline PLC was one of the first to stop research in chimps, back in 2008.

"Research we did on nonhuman primates was kept to a minimum" even before that, said spokeswoman Melinda Stubee.

Because chimpanzees used for commercial medical research generally are confined in the labs of contract testing companies, Conlee said the Humane Society is trying to convince them that there's no longer enough demand to continue warehousing chimpanzees for potential future work. She hopes they'll pay to support those chimpanzees in one of five U.S. accredited sanctuaries for former research chimps.

----

Online:

HTTP://WWW.HUMANESOCIETY.ORG/ISSUES/CHIMPANZEE-RESEARCH/

© 2014 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.

Friday, 31 January 2014 10:37
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One of every 10 clinical trials for adults with cancer ends prematurely because researchers can't get enough people to test new treatments, scientists report.
 
The surprisingly high rate reveals not just the scope and cost of wasted opportunities that deprive patients of potential advances, but also the extent of barriers such as money, logistics and even the mistaken fear that people won't get the best care if they join one of these experiments.
 
"Clinical trials are the cornerstone of progress in cancer care," the way that new treatments prove their worth, said Dr. Matthew Galsky of the Icahn School of Medicine at Mount Sinai Hospital in New York.
 
When an experimental drug or other treatment fails to make it to the market, people often think it didn't work or had too many side effects, but the inability to complete studies can doom a drug, too, Galsky said.
 
He helped lead an analysis of 7,776 experiments registered on Clinicaltrials.gov, a government web site for tracking medical experiments, from September 2005 to November 2011. All were mid- or late-stage studies testing treatments for various types of cancer in adults.
 
About 20 percent of the studies were not completed for reasons that had nothing to do with the treatment's safety or effectiveness (legitimate reasons for ending a study early). Poor accrual — the inability to enroll enough patients in enough time to finish the study — led to nearly 40 percent of premature endings.
 
Company-sponsored studies were less likely to be completed than those sponsored by the government or others. Late-stage cancer trials can cost companies "tens to even hundreds of millions of dollars," and that money is wasted if no clear answer on the drug's value is gained, said Dr. Charles J. Ryan, a cancer specialist at the University of California, San Francisco.
 
He heads the program for a conference later this week in San Francisco where Galsky's study will be presented. It was discussed Tuesday in a telebriefing by the American Society of Clinical Oncology, an organization for doctors who treat cancer.
 
Ryan and Galsky said they hoped the study would spur more research on why more patients don't participate. In most cases, the treatment being tested is provided for free, but there can be other costs such as lab tests. Some states require insurers to cover these additional costs, but others do not, so money may be one hurdle for patients.
 
Some doctors do not strongly encourage patients to participate in studies, and sometimes patients fear they'll get a dummy treatment instead of real medicine. However, in cancer clinical trials, ethical standards require that all patients get the current best care, plus a chance at an experimental treatment.
 
"Patients still have concerns about getting a placebo, but they're always going to get at a minimum the standard of care," said Shelley Fuld Nasso, head of the National Coalition for Cancer Survivorship, a patient advocacy and education organization.
 
Doctors need to encourage more patients to participate, and clinical trial designers need to make sure they are testing key questions and treatments to honor the contributions of study participants, she said.
 
___
 
Online:
 
Cancer patient info: http://www.cancer.net
 
Decision-making guide: http://bit.ly/L67zkT
 
Clinical trials: http://www.clinicaltrials.gov
 
Wednesday, 29 January 2014 02:11
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CONCORD, N.H. (AP) -- Families shopping for health insurance through the new federal marketplace are running into trouble getting everyone covered when children are eligible for Medicaid but their parents are not.

Children who qualify for Medicaid, the safety-net program for the poor and disabled, can't be included on subsidized family plans purchased through the federal marketplace, a fact that is taking many parents by surprise and leaving some kids stuck without coverage.

A California man says he was given false assurances that his children could be covered by the same plan he picked for his wife and himself, and a Florida father says his daughter is going without coverage while he waits for answers.

And in New Hampshire, some parents who've enrolled in private plans for themselves alone are finding out later that their children aren't eligible for Medicaid after all, leaving their kids with no options.

"The children are getting stuck in this spot where we've enrolled the parent, but we can't bring the children back on the family plan," Maria Proulx, senior legal counsel for Anthem Blue Cross and Blue Shield of New Hampshire, told a state advisory board panel this month.

The federal Centers for Medicare and Medicaid Services declined to say how the system is supposed to work for families and what problems have emerged. But a regional manager for CMS acknowledged the problem at the same New Hampshire meeting and said the agency is working on it, as did Proulx in a later interview.

"This is an important issue, and we're not taking it lightly," she said. "Even if this impacts only one family ... it's a big deal and we want to get it resolved as quickly as possible."

The federal government sets minimum guidelines for Medicaid eligibility, but states can choose to expand coverage beyond that. In some states, parents must have significantly lower incomes to gain Medicaid coverage for themselves than they would to get coverage for just their children, either through Medicaid or the Children's Health Insurance Program - also known as CHIP - the low-income health insurance program for children who don't qualify for Medicaid.

In North Port, Fla., Russell Clouden was thrilled to find a better, cheaper family plan through the new marketplace, then stunned to realize his 14-year-old daughter wouldn't be enrolled because she might qualify for Florida Healthy Kids, the state's version of CHIP. The federal government still hasn't transferred roughly 90,000 Medicaid files over to Florida officials, including Clouden's daughter's, so she still doesn't have insurance.

"Based on your income, they'll separate your kids from your primary policy and they shift them off to Medicaid or Healthy Kids and there's no way you can bring them back," said Clouden, whose daughter is an accomplished equestrian jumper.

"I'm kind of in limbo with her because I'm just hoping she doesn't get injured or sick," said Clouden, 53, who runs a restaurant franchise. "Without insurance, you've kind of got a knot in your stomach watching her jumping."

Insurance broker Matthew Dinkel in Fort Myers, Fla., said he has about 15 clients in Clouden's position.

"I have worried parents literally calling and texting me every day asking for an update," said Dinkel. "They canceled their old plans that covered their entire family and now they have coverage but their kids don't."

Jessica Waltman of the National Association of Health Underwriters said her group has raised the problem, and others, with federal officials and asked for a dedicated hotline or email address for insurance brokers to get answers.

"It's a nationwide issue that we've heard time and again, and it could have very significant coverage issues for families," she said.

Marc Jobin, a construction consultant in southern New Hampshire, said the process has been so confusing, he's put off a decision for himself, his wife and their two children, even though he's seen premiums that are significantly lower than what they pay now.

"We've been hesitating for two months now because the information is not clear," he said. "Around the holidays, we were thinking, `let's do this, let's sign up,' and then the latest problem is now our children will probably be thrown into the state health care system, but nobody knows what that means."

Mary Ann Cooney, associate commissioner of the New Hampshire Department of Health and Human Services, urged those awaiting Medicaid decisions to call their state offices directly. She said her office has been getting incomplete application information from the federal government, making it harder to contact people to determine their Medicaid eligibility, but situations are improving and the office is reaching out to hundreds of people each day.

"There's a real light at the end of the tunnel," she said.

But in the meantime, children are going without coverage. In California, Robert Clark said when he applied by phone through the Covered California marketplace, he was assured that his two children would be on the plan he picked. But he later got separate notices from the insurance company and Medi-Cal, the state's Medicaid program.

He called Covered California again and was told the person he'd previously talked to there was wrong and that his children had to be enrolled in Medi-Cal. Clark, the president of a Menlo Park technology company, doesn't like that prospect because the doctors his children have seen since their births don't take Medicaid.

"It's pretty frustrating," he said. "We've probably spent several days' worth of time on hold."

Instead, he's exploring whether he can enroll his children in individual, unsubsidized plans through Covered California. He recently found out his original application was "hung up," so he plans to resubmit a fresh application, but in the meantime has lost out on coverage for January.

"My daughter is in gymnastics," he said. "If she falls on her head, we need to be covered."

---

Associated Press Writer Kelli Kennedy in Fort Lauderdale, Fla., contributed to this report.

© 2014 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.

 

 

Monday, 27 January 2014 10:44
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WASHINGTON (AP) — Those nutrition labels on the back of food packages may soon become easier to read.
 
The Food and Drug Administration says knowledge about nutrition has evolved over the last 20 years, and the labels need to reflect that.
 
As the agency considers revisions, nutritionists and other health experts have their own wish list of desired changes.
 
The number of calories should be more prominent, they say, and the amount of added sugar and percentage of whole wheat in the food should be included. They also want more clarity on how serving sizes are defined.
 
"There's a feeling that nutrition labels haven't been as effective as they should be," says Michael Jacobson of the Center for Science in the Public Interest. "When you look at the label, there are roughly two dozen numbers of substances that people aren't intuitively familiar with."
 
For example, he says, most of the nutrients are listed in grams, the metric system's basic unit of mass. Jacobson says people don't really understand what a gram is.
 
Michael Taylor, the FDA's deputy commissioner for foods, says 20 years ago "there was a big focus on fat, and fat undifferentiated." Since then, health providers have focused more on calories and warned people away from saturated and trans fats more than all fats. Trans fats were separated out on the label in 2006.
 
The nutrition facts label "is now 20 years old, the food environment has changed and our dietary guidance has changed," says Taylor, who was at the agency in the early 1990s when the FDA first introduced the label at the behest of Congress. "It's important to keep this updated so what is iconic doesn't become a relic."
 
The FDA has sent guidelines for the new labels to the White House, but Taylor would not estimate when they might be released. The FDA has been working on the issue for a decade, he said.
 
There's evidence that more people are reading the labels in recent years.
 
According to an Agriculture Department study released this month, a greater percentage of adults reported using the nutrition facts panel and other claims on food packages "always or most of the time" in 2009 and 2010 compared with two years earlier.
 
The USDA study said 42 percent of working adults used the panel always or most of the time in 2009 and 2010, up from 34 percent. Older adults used it 57 percent of the time during that period, up from 51 percent.
 
One expected change in the label is to make the calorie listing more prominent, and Regina Hildwine of the Grocery Manufacturers Association said that could be useful to consumers. Her group represents the nation's largest food companies.
 
Hildwine said FDA also has suggested that it may be appropriate to remove the "calories from fat" declaration on the label.
 
It's not yet clear what other changes the FDA could decide on. Nutrition advocates are hoping the agency adds a line for sugars and syrups that are not naturally occurring in foods and drinks and are added when they are processed or prepared. Right now, some sugars are listed separately among the ingredients and some are not.
 
It may be difficult for the FDA to figure out how to calculate added sugars, however. Food manufacturers are adding naturally occurring sugars to their products so they can label them as natural — but the nutrition content is no different.
 
Other suggestions from health advocates:
 
— Add the percentage of whole wheat to the label. Many manufacturers will label products "whole wheat" when there is really only a small percentage of it in the food.
 
— Clearer measurements. Jacobson of CSPI and others have suggested that the FDA use teaspoons, as well as grams, for added sugars, since consumers can envision a teaspoon.
 
— Serving sizes that make sense. There's no easy answer, but health experts say that single-size servings that are clearly meant to be eaten in one sitting will often list two or three servings on the label, making the calorie and other nutrient information deceptive. FDA said last year that it may add another column to the labels, listing nutrition information per serving and per container. The agency may also adjust recommended serving sizes for some foods.
 
— Package-front labeling. Beyond the panel on the back, nutrition experts have pushed for labels on the package front for certain nutrients so consumers can see them more easily. The FDA said several years ago it would issue guidelines for front of pack labeling, but later said it would hold off to see whether the industry could create its own labels.
 
Tracy Fox, a Washington-based nutrition consultant, says clearer information is needed to balance the billions of dollars a year that the food industry spends on food marketing.
 
"There's a lot of information there, it's messy," she says. "There may be a way to call out certain things and put them in context."
Friday, 24 January 2014 04:23
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