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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
 
Published in Health & Fitness
Friday, 24 January 2014 04:23

FDA to revise nutrition facts label

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."
Published in Health & Fitness
Friday, 15 November 2013 03:51

Scabies outbreak reported in De Soto schools

   Parents in the De Soto School District are being warned about an outbreak of scabies.  

   District 73 officials sent a letter home with students Thursday notifying parents that one high school student, a junior high student, and an elementary student have been sent home with the skin condition.  

   Scabies is caused by tiny mites burrowing beneath the skin.  It's extremely itchy and highly contagious.  

   District officials say they are taking steps to disinfect schools.

   Students with scabies can't return to school without a doctor's note.

   De Soto is about 50 miles south of St. Louis in Jefferson County.

 
Published in Local News
WASHINGTON (AP) — Diners will have to wait a little longer to find calorie counts on most restaurant chain menus, in supermarkets and on vending machines.

The head of the Food and Drug Administration says writing a new menu labeling law "has gotten extremely thorny" as the agency tries to figure out who should be covered by it.

The 2010 health care law charged the FDA with requiring restaurants and other establishments that serve food to put calorie counts on menus and in vending machines. The agency issued a proposed rule in 2011, but the final rules have since been delayed as some non-restaurant establishments have lobbied hard to be exempt.

The FDA has said the rules may come out this spring, but the agency may not meet that deadline.
Published in Health & Fitness

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