Thursday, March 13th, 2014
Despite FDA warnings against drinking unpasteurized, “raw” milk, some parents continue to choose it for their families, citing a number of health claims including that it is a gentler alternative for lactose intolerant people. A new study published in the Annals of Family Medicine has found, however, that no such link with lactose intolerance exists. More from Time.com:
Only a small population of people drink unpasteurized milk, also known as “raw” milk, but its increasing popularity has some medical groups concerned. Some raw milk advocates argue that it’s healthier for us since raw milk contains no antibiotics or hormones, while others say it’s better for people with lactose allergies. For its part, the FDA advises against drinking raw milk, which can contain bacteria from fecal matter and sometimes be fatal, and has long stated that it doesn’t help with lactose intolerance.
But a new study published in the Annals of Family Medicine is definitively poking holes in the allergy theory, by reporting that lactose-intolerant people have the same symptoms from raw and pasteurized milk.
Advocates for raw milk claim that it contains good bacteria that can help with lactose absorption. “When I heard that claim it didn’t make sense to me because, regardless of the bacteria, raw milk and pasteurized milk have the same amount of lactose in them,” said study author Christopher Gardner, a professor of medicine at the Stanford Prevention Research Center in a statement. “But I liked the idea of taking this on since it seemed like a relatively straightforward and answerable question because the symptoms of lactose-intolerance are immediate.”
The study was small, with only 16 lactose-intolerant participants. All 16 tried three different types of milk–raw, pasteurized, and soy–over multiple eight-day periods.
For eight days, the participants were randomly assigned to one of the three milks, and they drank an increasing amount of that milk as the study period went on. They then reported their allergy symptoms, which were usually gas, diarrhea, and cramping, and rated them on a scale of 0 to 10. Their breaths were also measured for hydrogen, which can indicate undigested lactose in the colon and intolerance.
After the first eight days of drinking one type of milk, the participants took a week off where they drank no milk, and then started up again with another eight days of a different type of milk. To mask which type of milk participants were drinking, researchers randomized the order and added sugar-free vanilla syrup. Soy, which doesn’t contain lactose, acted as the control.
Researchers found no differences in the hydrogen breath tests between consuming pasteurized or unpasteurized milk. Participants also rated their symptom severity the same, regardless of the type of milk they drank.
Image: Milk, via Shutterstock
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Wednesday, March 12th, 2014
A 7-year-old Memphis boy who is suffering from heart and kidney failure has been denied an experimental drug that could very well help improve his condition. The drug company, in denying the drug to Josh Hardy, says its efforts to get the drug to market–with full FDA approval–will be severely impeded if the medication is given to patients at this stage. More from CNN:
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Here’s the way it works: According to the Food and Drug Administration, if someone has a serious or immediately life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug, one that they’re still studying and has not yet been approved by the FDA.
Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.
But pharmaceutical companies often say no, as they did to Josh Hardy.
“Our son will die without this drug,” said Todd Hardy, Josh’s father. “We’re begging them to give it to us.”
So now, like many families, the Hardys have turned to the media, Facebook, and change.org to pressure the drug company to change its mind.
Countless members of “Josh’s army” have responded with angry tweets to @chimerix, telling them to “open their hearts,” asking the executives how they can sleep at night.
“Everyone is watching,” one tweeter warned the company. Others have tweeted out the e-mail addresses of the company’s board members. Chimerix executives say they’ve received physical threats.
Moch, the company president, has read these tweets and said he is heartbroken, but the issue is complex and unsuitable for a 144-long character debate.
At its very simplest, this is it: Chimerix is going full speed ahead to get the drug on the market hopefully by the end of 2016, and if they spend time and money on compassionate use cases, it would greatly hinder their effort to get the drug, brincidofovir, on the market and available to everyone.
The company would have to dish out $50,000 per compassionate-use patient, since insurance doesn’t usually pay for experimental drugs, Moch said. And perhaps even more important than the money, it would divert manpower in this 50-person company, since they’d have to handle the requests and then get the patient’s records and follow up with them, as required by the FDA.
Monday, February 10th, 2014
The Food and Drug Administration has announced new guidelines meant to make sure infant formula is both safe and nutritious. The new guidelines are based on two years’ worth of research, during which time Gerber voluntarily recalled some formula because of a strange odor, and some brands of organic formula were found to contain high levels of inorganic arsenic. More on the FDA’s new rules from The Associated Press:
Most formula makers already abide by the practices, but the FDA now will have rules on the books that ensure formula manufacturers test their products for salmonella and other pathogens before distribution. The rules also require formula companies to prove to the FDA that they are including specific nutrients — proteins, carbohydrates, fats, vitamins and minerals — in their products.
It is already law that formula must include those nutrients, which help babies stay healthy. But the new rules will help the FDA keep tabs on companies to make sure they are following the law. The rule would require manufacturers to provide data to the FDA proving that their formulas support normal physical growth and that ingredients are of sufficient quality.
“The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being,” Michael Taylor, the FDA’s deputy commissioner for foods, said.
The rules also are aimed at new companies that come into the market. In recent years, grocery store aisles have become even more crowded with new kinds of formula, some capitalizing on natural or organic food trends.
The agency said breastfeeding is strongly recommended for newborns but that 25 percent of infants start out using formula. By three months, two-thirds of infants rely on formula for all or part of their nutrition.
The FDA doesn’t approve formulas before they are marketed but formula manufacturers must register with the agency. The FDA also conducts annual inspections of facilities that manufacture infant formula — far more often than the agency does inspections of other food facilities.
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Image: Infant formula, via Shutterstock
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Tuesday, November 26th, 2013
The vaccine against pertussis, which is commonly known as whooping cough, has been perplexing researchers who are observing that it’s less effective than anticipated at halting the spread of the disease. 2012 was the worst whooping cough outbreak in 50 years, and the continued presence of the disease is troubling, especially as many families choose not to have their children vaccinated–or to get Tdap booster shots themselves.
A new study by the Food and Drug Administration may be onto the reason why even in communities with high vaccination rates, whooping cough can appear and spread. More from NBC News:
The research suggests that while the vaccine may keep people from getting sick, it doesn’t prevent them from spreading whooping cough — also known as pertussis — to others.
“It could explain the increase in pertussis that we’re seeing in the U.S.,” said one of the researchers, Tod Merkel of the Food and Drug Administration.
Whooping cough is a highly contagious disease that can strike people of any age but is most dangerous to children. It was once common, causing hundreds of thousands of illnesses annually and thousands of deaths. But after a vaccine was introduced in the 1940s, cases dropped to fewer than 5,000 a year.
The vaccine was replaced in the 1990s because of side effects that included pain and swelling from the shot and fever. The newer vaccine is part of routine childhood vaccinations as well as adult booster shots.
But cases have rebounded. Last year was the nation’s worst year for whooping cough in six decades — U.S. health officials received reports of more than 48,000 cases, including 18 deaths.
This year hasn’t been half as bad — about 20,000 reported illnesses, including six deaths so far. Whooping cough ebbs and flows in cycles, so experts aren’t surprised to see cases recede. But 20,000 can still be seen as a lot when a widely used vaccine is supposed to protect the public.
Image: Child coughing, via Shutterstock
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Thursday, November 7th, 2013
The Food and Drug Administration of the federal government has announced a that partially hydrogenated oils, which are a major source of “trans fats” in processed foods, are no longer “generally recognized as safe” in the U.S. food supply. The move is considered a first step toward a ban of the artificial fats in most foods, as CNN.com reports:
If the preliminary determination is finalized, according to the FDA, then partially hydrogenated oils will become food additives that could not be used in food without approval. Foods with unapproved additives cannot legally be sold.
Trans fat can be found in processed foods including desserts, microwave popcorn products, frozen pizza, margarine and coffee creamer, and has been linked to an increased risk of heart disease.
Partially hydrogenated oil is formed when hydrogen is added to liquid oils to make solid fats, like shortening and margarine. It increases the shelf life and the flavor of foods. Partially hydrogenated vegetable oil, or shortening, was used in American kitchens as early as 1911.
However, in recent years many food manufacturers have taken steps to limit or eliminate trans fat from their products.
McDonald’s, for instance, stopped cooking its french fries in trans fat more than a decade ago. The company’s website says all its fried menu items are free of trans fat.
New York City in 2007 adopted a regulation banning partially hydrogenated vegetable oils and spreads in restaurants.
Trans fat intake among American consumers decreased from 4.6 grams per day in 2003 to about a gram a day in 2012, according to the FDA.
However, “current intake remains a significant public health concern,” FDA Commissioner Margaret Hamburg said in a written statement.
There is no safe level of consumption of trans fat, Hamburg said. It has been shown to raise the “bad,” or LDL, cholesterol.
Image: Margarine on bread, via Shutterstock
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