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Working Long Hours Could Increase Your Risk of Stroke and Heart Disease

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Burning the candle at both ends might impress your boss, but you could be sacrificing your health in the process.

A study published in The Lancet on Wednesday finds a strong connection between people who work 55 or more hours per week and cardiovascular disease. Those who work such long hours were found to have a 33% increased risk of stroke and 13% greater chance of developing coronary heart disease compared to people who work the standard 35- to 40-hour work week.

Researchers from University College London reviewed 42 studies of hundreds of thousands of men and women from Europe, the U.S., and Australia for several years. Their results held even after controlling for demographic factors—age, sex, socioeconomic status—and health behaviors—like smoking, alcohol consumption, and physical activity.

Working overtime in general, even if it’s not the 55 hour maximum the group studied, also affects health outcomes negatively. Working between 41 to 48 hours led to a 10% increased risk of stroke and upping work hours to between 49 and 54 hours a week caused a 27% increased risk of stroke.

The authors aren’t sure exactly what the link is, but noted a few potential causes. For one, working long hours tends to be correlated with risky health behaviors, like drinking more alcohol or sitting for hours at a time. Those behaviors, combined with the stress associated with working overtime, could be a perfect recipe for a stroke or cardiovascular strain.

This article originally appeared on Time.com.




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Don’t Let Bedbugs Ruin Your Vacation


THURSDAY, Aug. 20, 2015 (HealthDay News) — Bedbug infestations are on the rise, but savvy travelers know how to stop the pests from spoiling holiday trips.

Before you settle into a hotel room, check for signs of the tiny blood-sucking parasites, advised Dr. Theodore Rosen, professor of dermatology at Baylor College of Medicine and chief of dermatology at the Michael E. DeBakey Veterans Affairs Medical Center in Houston. Infestations have been on the rise in the United States for the past several years.

Bedbugs tend to stay within three feet of a bed but may move farther. Check the mattress, box spring and bed frame, both sides of the headboard, and the inside and back of the nightstand.

“Bedbugs tend to settle in corners, so make sure to pay attention to those areas. Look closely anywhere there’s a 90-degree angle,” Rosen said in an American Academy of Dermatology news release.

Bedbugs are roughly the size of an apple seed, so they and their eggs can be difficult to spot, he warned.

Signs of bedbug infestation include specks of blood, small dark spots of bedbug excrement and their discarded outer shells. A sweet, musty odor in the room may indicate a heavy infestation of the tiny bloodsuckers.

If you see signs of bedbugs, ask for another room that is not next to, immediately above or immediately below the infested room, Rosen said.

Store your luggage as high and as far away from the bed as possible. Place suitcases on the dresser or luggage rack instead of on the floor or the bed. Hang clothes in the closet, rather than putting them in drawers where bedbugs may be hiding.

If you think you picked up bedbugs at a hotel, inspect all of your belongings when you get home, ideally before you take anything inside. If you find evidence of bedbugs, wash and dry all the clothes using the hottest settings, and vacuum or steam clean your luggage.

But even people who take all the right precautions can still be affected by bedbugs.

“People associate bedbugs with filth, but a bedbug infestation doesn’t mean you’re dirty. Anyone can get bedbugs, no matter how clean or careful they are,” Rosen said.

More information

The U.S. Centers for Disease Control and Prevention has more about bedbugs.





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People With Few Moles Apt to Develop Deadlier Skin Cancer: Study


THURSDAY, Aug. 20, 2015 (HealthDay News) — People who have many moles are at increased risk for melanoma skin cancer, but people with fewer moles may be more likely to develop a more aggressive form of the disease, a new study suggests.

Melanoma is the deadliest type of skin cancer.

For the study, researchers analyzed medical records of 281 melanoma patients: 89 had more than 50 moles and 192 had fewer than 50 moles.

Patients with fewer moles had thicker, more aggressive melanoma and were more likely to be diagnosed at a later age than those with more moles, according to the study scheduled for presentation Thursday at an American Academy of Dermatology meeting in New York City.

Doctors may be more likely to educate patients with a large number of moles about their increased risk of developing melanoma, said study author Dr. Caroline Kim. Kim is director of the pigmented lesion clinic at Beth Israel Deaconess Medical Center and an assistant professor of dermatology at Harvard Medical School in Boston.

As a result, people with many moles may be more likely to get regular skin exams, which means their melanoma would be detected at an earlier stage, when it is thinner and less aggressive, she explained.

Biology may also be a factor.

“We already know that melanomas are not all the same genetically,” Kim said in an academy news release.

“It’s possible that there are different pathways that drive melanoma in these two patient groups, resulting in different degrees of aggressiveness. If patients with fewer moles are more prone to aggressive melanoma, then we need to make sure that they are also being educated and screened, in addition to patients with many moles,” she suggested.

The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

Further large-scale research is needed to confirm results of this study, Kim said.

More information

The U.S. National Cancer Institute has more about melanoma.





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Why the Aging Brain Is More Vulnerable to Alzheimer’s



By Dennis Thompson
HealthDay Reporter

THURSDAY, Aug. 20, 2015 (HealthDay News) — Age is the greatest risk factor for Alzheimer’s disease, and researchers now think they know why that’s the case.

New cutting-edge technology reveals that as you age, your brain becomes less and less capable of flushing away a toxic waste product of brain activity called beta-amyloid, the researchers said.

Beta-amyloid proteins can clump together, forming larger amyloid plaques in the spaces between neurons. These amyloid plaques are a hallmark of Alzheimer’s disease, the most common form of dementia.

“This is a clue as to why age is the number one, two and three risk factor for Alzheimer’s disease,” said study senior author Dr. Randall Bateman, director of the Dominantly Inherited Alzheimer Network Trials Unit at the Washington University School of Medicine in St. Louis. “As we slow down our ability to clear away these sticky proteins, the risk of having these sticky proteins build up in the brain goes up and up as we age.”

Using this knowledge, future research might come up with a medication or therapy that increases the brain’s ability to flush out beta-amyloid, thus reducing or eliminating the risk of Alzheimer’s disease, he said.

After age 65, the risk of Alzheimer’s disease doubles every five years, the researchers said in background information with the study. At least two out of five people 85 and older are living with the devastating condition.

Keith Fargo, director of scientific programs and outreach for the Alzheimer’s Association, said, “We’ve known for a long time that age is the primary risk factor for Alzheimer’s disease. What we haven’t known is why.”

The body builds all of its proteins — including beta-amyloid — by using amino acids as the building blocks.

“We all have amyloid-beta in our brains,” Bateman explained. “It’s made normally by the thinking cells of our brain, the neurons. They generate amyloid-beta, and the more they fire or communicate with each other — the more they send little signals to each other — the more they make.”

To explore the effects of age, the researchers used a new technology called stable isotope-linked kinetics (SILK) that allowed them to “tag” amino acids, Bateman said.

The researchers infused the blood of 100 volunteers between ages 60 and 88 with “tagged” amino acids. They then took hourly samples of the patient’s cerebrospinal fluid to track the course of beta-amyloid proteins built from those amino acids.

Earlier research had shown that people in their 30s typically take about four hours to clear half the beta-amyloid protein from their brain, Bateman said.

But people 80 or older take about two and a half times longer — more than 10 hours — to flush beta-amyloid from their brains, Bateman and his colleagues discovered.

“That’s a pure age effect,” Bateman said. “It doesn’t matter if you have plaques or not. The older you get, the slower it is. And it was highly precisely correlated with age — we could actually predict what age a person was just based upon how quickly they could clear away amyloid-beta.”

In patients who already had evidence of amyloid plaques, the researchers found that their beta-amyloid proteins were more likely to clump together and form those plaques, rather than be flushed out of their brain.

They also learned that reduced flushing of beta-amyloid is associated with clinical symptoms of Alzheimer’s disease such as memory loss, dementia and personality changes.

No one is yet sure how the brain disposes of beta-amyloid, Bateman said. It might be flushed out through either blood or spinal fluid, or the brain might have some internal means of breaking down the toxic protein.

But when scientists figure out that mechanism, they might be able to make a drug or a therapy that enhances that process and rids the brain of beta-amyloid faster, Fargo said.

“There’s nothing new your doctor is going to have next week based on this, but maybe 10 years from now there will be,” he said.

The study was published recently in the journal Annals of Neurology.

More information

For more on Alzheimer’s disease, visit the U.S. National Institute on Aging.





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Workaholics May Face Higher Stroke Risk: Study


WEDNESDAY, Aug. 19, 2015 (HealthDay News) — Millions of workers who put in lots of overtime may be upping their odds for a stroke, a new study contends.

“Working long hours is associated with a significantly increased risk of stroke, and perhaps also coronary heart disease,” study author Mika Kivimaki, a professor of epidemiology at University College London, said in a news release from The Lancet. The journal published the findings Aug. 19.

The study couldn’t prove cause and effect, but one expert said today’s harried workers should seek ways to curb the risk.

“The take-home message for all the workers burning the midnight oil: Make time for physical activity, ensure a proper diet, watch your alcohol consumption and ensure good sleeping habits,” said Dr. Paul Wright, chair of neurology at North Shore University Hospital in Manhasset, N.Y.

“If you are not feeling well or if something does not feel right, see your physician,” he added.

In the study, Kivimaki’s team looked at data from 25 studies that included more than 600,000 men and women in the United States, Europe and Australia. Participants’ health outcomes were followed for an average of 8.5 years.

In that study, people who worked 55 hours or more per week were 13 percent more likely to develop heart disease than those who worked the standard 35 to 40 hours a week.

A second analysis of data from 17 studies included nearly 529,000 men and women who were followed for an average of more than seven years. It found that those who worked 55 hours or more a week were one-third more likely to suffer a stroke than those who worked the standard number of hours.

And the longer hours people worked, the higher their stroke risk, the study found. Compared to those who worked a standard number of hours per week, the risk of stroke was 10 percent higher among those who worked 41 to 48 hours and 27 percent higher among those who worked 49 to 54 hours.

Why could long hours at the factory, shop or office be tough on your health? The study authors said a number of factors — physical inactivity, higher drinking rates and higher stress levels — may be to blame.

Wright acknowledged that one solution — simply working less — is not always in the employee’s power.

“Many individuals may not be able to decrease their work hours,” he said, so “we need to start to change society’s mindset and educate the public that physical activity must be a part of the equation for successful aging and disease prevention.”

Also, the study found that “people with long work hours tended not to go to the doctor for evaluations,” Wright noted. “With [some] companies now promoting wellness programs, this will hopefully change.”

Dr. Stephan Mayer directs neurocritical care at Mount Sinai Health System in New York City. He said that he was “surprised” by the magnitude of the effect seen in the study.

“The risk is almost as bad as smoking, which increases the risk of stroke by about 50 percent,” he said. “Although we don’t know for sure, to my mind the most plausible explanation is chronic triggering of the stress response that comes with working long hours, pressure to perform, and not enough time for family, loved ones and peaceful rest. “

Mayer believes the findings are “further evidence that we as individuals need to be mindful of and take responsibility for work-life balance.”

More information

The U.S. National Institute of Neurological Disorders and Stroke outlines how to prevent stroke.





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Why This Breastfeeding Photo Is Causing So Much Controversy

 

A Pennsylvania mother sparked a fiery debate online recently after she shared a photo of herself nursing her son and her best friend’s child on Facebook.

Jessica Anne Colletti, 27, has been babysitting her friend Charlie Interrante’s 18-month-old son, Mateo, and feeding him for about a year, she explained in a photo caption on the Mama Bean Parenting Facebook page. When Mateo gets hungry, she allows him to breastfeed alongside her own 16-month-old, Lucian.

“So much love between these milk siblings, it’s a special bond between us all,” Colletti said.

The photo quickly collected a slew of comments, ranging from “Wish I had a nursing babysitter!” to “Don’t breastfeed someone else’s child. That’s just wrong.”

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Plenty found the photo “amazing” and “beautiful” and came to the young mom’s defense by offering their own anecdotes about breastfeeding another mother’s child. But some critics questioned whether Colletti was interfering with the bond between Mateo and his biological mother, while still others argued the boys were just too old to be breastfeeding.

Regardless of the public attention, Colletti stands by her and her friend’s breastfeeding arrangement, telling People she thinks “people are misinformed.”

“They think it’s gross bodily fluid that shouldn’t be shared or transferred in any way. And I can understand, if people are receiving donated breast milk, they want to have it tested,” she explained. “But if you know the mother directly and she’s healthy, and you know everything about her, it’s a perfectly healthy relationship to have.”

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And in fact, the expert guidelines back her up. For one thing, the boys aren’t too old: The American Academy of Pediatrics recommends breastfeeding for at least 12 months, and continuing as long as mother and baby want to thereafter. (The World Health Organization recommends continuing until the child is at least 2.)

According to the U.S. Centers for Disease Control and Prevention (CDC), there is little risk to a child who is given breast milk from a woman who’s not his mother as long as the donor does not have any serious infectious diseases (such as HIV). “Before the invention of bottles and formula, wet nursing was the safest and most common alternative to breastfeeding by the natural mother,” concluded a 2009 paper in the Journal of Perinatal Education.

Colletti began breastfeeding her friend’s son because he was not responding well to formula and his mom was unable to pump at work. The arrangement has worked out so well for the pair of moms that the two families moved in together last month, Colletti explained to People. “It’s a lot easier for us to all live under the same roof. It develops a routine for the babies together,” she said. “This works really well for us.”

RELATEDHow This Breastfeeding Mom Fought Back Against A Stranger Who Shamed Her on Facebook




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Ob-Gyn Group Advises on Spotting Dangerous Pregnancy Complication


WEDNESDAY, Aug. 19, 2015 (HealthDay News) — Preeclampsia — a condition where blood pressure in a pregnant woman can rise to life-threatening levels — is a key complication obstetricians try and predict early in pregnancy.

While commercial tests are being marketed for use in the first trimester to predict the risk of early onset preeclampsia, new recommendations from the American College of Obstetricians and Gynecologists (ACOG) say there’s a lack of evidence that the tests offer any benefits, and they may do more harm than good.

Instead, ACOG is holding to its position that taking a detailed medical history to assess a woman’s risk factors in the first trimester is still the recommended screening approach for early-onset preeclampsia.

This approach should remain the only method of screening for preeclampsia until studies can prove that aspirin or other treatments reduce the incidence of preeclampsia among women who are considered at high risk, based on predictive tests conducted in the first trimester, ACOG said.

Preeclampsia occurs in 5 percent to 10 percent of pregnancies and can lead to preterm birth, complications and death in mothers, and also increase women’s long-term risk of heart disease, the group noted.

Two experts agreed with the ACOG guideline.

“If one undergoes a screening test when its effectiveness has not yet been established objectively — as in this case — there is potential for further unnecessary diagnostic testing, patient stress and the wasting of resources,” said Dr. Catherine Herway, assistant director of maternal-fetal medicine at Staten Island University Hospital in Staten Island, N.Y.

“A screening program should also be cost-effective,” she noted, and “screening the entire population [of pregnant women] for preeclampsia would be quite costly.”

Dr. Fahimeh Sasan is an assistant professor of obstetrics, gynecology and reproductive science at the Icahn School of Medicine at Mount Sinai, in New York City. She said the ACOG guidelines are “consistent” with policies at her hospital.

“I agree that currently taking a detailed personal patient history at the initial prenatal visit, including her past obstetrics history, are the most important aspects of triaging a woman to be at risk for developing preeclampsia later in the pregnancy,” she said.

“Having a high suspicion that a woman is at risk for developing preeclampsia allows the physician to monitor the patient closer throughout her pregnancy and be more vigilant in monitoring her blood pressure and looking for signs and symptoms,” Sasan said.

The new policy was published Aug. 19 in Obstetrics & Gynecology.

More information

The U.S. National Institute of Child Health and Human Development has more about preeclampsia and eclampsia.





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Women Don’t Have to Suffer Through Severe Morning Sickness, Experts Say



By Maureen Salamon
HealthDay Reporter

WEDNESDAY, Aug. 19, 2015 (HealthDay News) — Expectant mothers hit hard with nausea and vomiting in early pregnancy don’t need to muddle through debilitating symptoms, new recommendations say.

In updating 11-year-old guidelines on treating morning sickness, the American College of Obstetricians and Gynecologists (ACOG) now suggests women pair vitamin B6 and the antihistamine doxylamine to treat persistent, disruptive nausea and vomiting. The medications are sold separately over-the-counter or combined in prescription form.

Meanwhile, further review of a commonly used morning sickness drug, ondansetron (Zofran), has prompted ACOG to pull back on supporting its use since more recent data suggest the drug may be linked to birth defects.

“I think it’s up to each individual patient, in talking with her clinician, to decide what steps they want to take to treat nausea and vomiting,” said Dr. Aaron Caughey, a member of ACOG’s obstetrics practice committee who co-authored the new guidelines.

“Certainly there are a lot of options that aren’t medications per se, such as eating frequent small meals of simple carbs like crackers . . . or avoiding smells that trigger nausea,” added Caughey, chairman of obstetrics and gynecology at Oregon Health and Science University in Portland. “I think it’s a conversation between a patient and her clinician whether they want to embark on treatment at all.”

The new guidelines were published online Aug. 19 in advance of the September print issue of ACOG’s Practice Bulletin.

About half of all pregnant women experience nausea and vomiting together, while 25 percent have nausea alone, according to the study. Recurrence of these symptoms in subsequent pregnancies ranges from 15 to 81 percent.

But for most women, morning sickness does not endanger either them or the fetus. Up to 3 percent of pregnant women represent the extreme end, with nausea and vomiting so severe that hospitalization may be necessary to replace lost fluids. The reasons for morning sickness are not completely understood.

Reviewing decades of scientific data on morning sickness and its remedies, Caughey and his colleagues noted that its commonness in early pregnancy may lead women and their obstetricians to minimize its impact. Even if a woman doesn’t require supplementary intravenous fluids, he said, some find that day-long nausea and vomiting make it difficult to work or fulfill other responsibilities.

Because of the individual nature of pregnancy, the ACOG group decided each woman’s perception of her symptoms should play a critical role in deciding whether or when to treat pregnancy-related nausea and vomiting.

One expert agreed with that approach.

“Everybody has their own tolerance and their own experience,” said Dr. Matthew Hoffman, vice chairman of obstetrics and gynecology and the division of education and research at Christiana Care Health System in Wilmington, Del.

“Given the safety of the current recommendations, I think that’s more than appropriate,” added Hoffman, who wasn’t part of the ACOG group that authored the guideline. “It’s better to get the symptoms under control in advance of people becoming profoundly dehydrated.”

Caughey said the guidelines were essentially “tweaked” to recommend the first-line use of doxylamine and vitamin B6 and to demote ondansetron, which the U.S. Food and Drug Administration now recommends not be given intravenously in doses greater than 16 milligrams.

Additionally, pregnancy-related nausea and vomiting should be distinguished from other conditions that could lead to those symptoms, requiring a different approach, the guidelines added.

Caughey and Hoffman pointed out that several “folk remedies” for acute morning sickness — including ginger-containing drinks, cookies and other products — are still useful options for those who want to try a non-drug approach before trying medications. Taking vitamin B6 on its own also can help, they said.

While some women are loath to take any medications during pregnancy — remembering stories of how the drug thalidomide, hailed as a “miracle cure” for morning sickness in the 1960s, maimed thousands of babies — holding out isn’t necessary if symptoms are profound, obstetricians said.

“I think it’s an issue of trying to make sure people aren’t muddling through [morning sickness] to the point where they put themselves in danger . . . and to err on the side of considering medications, knowing there’s a safe alternative,” Hoffman said.

More information

The American Academy of Family Physicians offers an overview of morning sickness.





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Genetically Modified Foods, Herbicides and Human Safety



By Dennis Thompson
HealthDay Reporter

WEDNESDAY, Aug. 19, 2015 (HealthDay News) — Farm fields are becoming soaked with increasing amounts of suspected cancer-causing herbicides, thanks to the spread of genetically modified crops that are immune to these chemicals, two researchers contend.

They make their argument in a Perspective piece in the Aug. 20 issue of the New England Journal of Medicine.

Farmers’ use of glyphosate — a weedkiller most commonly known as Roundup — has increased by a factor of more than 250 in the United States, climbing from 0.4 million kilograms in 1974 to 113 million kilograms in 2014, the researchers said.

This increase is due to crops such as corn and soybeans that have been genetically altered to be “Roundup-Ready,” so they can’t be affected by these herbicides, said one of the researchers, Charles Benbrook. He is a research professor at the Washington State University Center for Sustaining Agriculture and Natural Resources.

The herbicides leave the genetically modified crops unscathed, while still controlling weed growth on farm fields, according to Benbrook and colleague Dr. Philip Landrigan, who’s with the department of preventive medicine at the Icahn School of Medicine at Mount Sinai in New York City.

Cancer researchers have recently raised concerns about the safety of these farm chemicals, which had long been considered benign to humans because they attack plants and not animals, said Jennifer Sass, a senior scientist with the Natural Resources Defense Council in New York City.

The International Agency for Research on Cancer (IARC) earlier this year classified glyphosate as a “probable human carcinogen,” following studies that linked the chemical to non-Hodgkin’s lymphoma, the Perspective authors noted. The IARC also classified a second widely used herbicide, 2,4-dichlorophenoxyacetic acid (2,4-D), as a “possible human carcinogen.”

Both of these herbicides have been combined in a new product from Dow AgroSciences called Enlist Duo, which received U.S. Environmental Protection Agency approval in 2014.

Benbrook and Sass are concerned that heavy use of these two herbicides could pose a risk to the health of people who work on or live near farm fields.

“If you keep hitting somebody over and over, even if each punch isn’t great, you’re going to do as much or more damage as you would with one hard punch,” Sass said. “That’s what these herbicides are doing.”

Farmers are using larger quantities of herbicide on their fields because weeds are becoming resistant to the chemicals, much in the same way genetically modified crops are resistant, Benbrook said.

The advent of genetically modified corn and soybeans meant that farmers could just spray an appropriate herbicide across their entire field, coating both crops and weeds, he said. The crops would ignore the herbicide, but the weeds would succumb.

But weeds that are resistant to glyphosate have emerged on nearly 100 million acres in 36 states, requiring fields to be treated with multiple herbicides that include 2,4-D, the authors said in their paper.

“As the resistant weeds have become a bigger problem, farmers have responded by spraying more,” Benbrook said, increasing both the quantity of weedkiller they use and the number of times they spray their fields.

Those chemicals have begun to find their way into the water supply surrounding large farm operations, Benbrook said. Recent studies have found traces of glyphosate in surface water, runoff from rainfall, and even urine from humans.

In a company statement, Dow AgroSciences said the safety of glyphosate and 2,4-D has been shown through “extensive data.”

“These are two of the most thoroughly studied herbicides in the world, and farmers have used them safely and effectively for decades,” the company said.

Glyphosate’s potential risk to humans is mitigated by a few factors, said Kenneth Portier, vice president of the American Cancer Society’s Statistics and Evaluation Center.

Humans do not process glyphosate and 2,4-D in the same way that they absorb harmful pesticides like DDT, he said.

“With glyphosate, most of it is excreted in fecal material, which means it’s not bioprocessed,” Portier said. “Your stomach and intestines don’t take it up and put it in the bloodstream.”

Also, researchers have not been able to rule out other chemicals as potential sources of the cancer risk that has been ascribed to glyphosate, he said.

“They see increased risk in these agricultural workers, but there’s the understanding that they are exposed to more than just glyphosate,” Portier said. “They’re exposed to this whole mix of chemicals, so it’s hard to tease out what’s the effect of this one chemical.”

That said, the American Cancer Society does take seriously the potential threat posed by glyphosate and 2,4-D, Portier said, and would like manufacturers to come up with alternative products.

“We don’t like to see man-made carcinogens freely circulating in the environment,” he said. “We would prefer to use chemicals in agricultural production that are not human carcinogens, even probable carcinogens.”

Given the cancer concerns regarding glyphosate and 2,4-D, Benbrook and Landrigan ask the U.S. Environmental Protection Agency to delay implementation of its decision to permit use of Enlist Duo.

Dow AgroSciences disagrees.

“Contrary to the claims of the authors, regulatory approvals for Enlist Duo herbicide are based on detailed government health and environmental assessments, including review of recent, published state-of-the-art studies,” the company said in a statement. “The U.S. Environmental Protection Agency spent nearly four years on its review and consideration of public input, repeatedly extending the comment period.”

The EPA review took into account the cancer concerns raised by the IARC, “and found no basis for concern relative to potential carcinogenicity,” Dow AgroSciences said.

“It is important to note that IARC only focuses on whether a substance theoretically could cause cancer, not whether it will cause cancer in real-world circumstances,” the company said. “No national regulatory body in the world considers these herbicides a carcinogen.”

More information

For more on glyphosate, visit the International Agency for Research on Cancer.





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‘Low T’ Therapy Has Yet to Be Proven: FDA



By Amy Norton
HealthDay Reporter

WEDNESDAY, Aug. 19, 2015 (HealthDay News) — Testosterone supplements have long been marketed to aging men as a fountain of youth and virility, but there is still no proof they are safe or effective, according to the U.S. Food and Drug Administration.

Writing in the Aug. 20 edition of the New England Journal of Medicine, FDA officials said that only controlled clinical trials can show whether men benefit from treatment to reverse age-related dips in testosterone.

The agency is now requiring product manufacturers to conduct those trials.

As it stands, testosterone supplements are approved only for men with certain medical conditions that cause abnormally low levels of the hormone — such as damage to brain areas that control testosterone production.

But once the FDA approves a drug, doctors are free to prescribe it as they see fit. And most American men on testosterone therapy have no clear medical condition; they’re using it to counter the aging process, the researchers said.

Between 2009 and 2013, the number of U.S. men on testosterone shot up from 1.3 million to 2.3 million, according to the FDA. And the most common reason, the agency says, is the vague diagnosis of “testicular hypofunction, not elsewhere classified.”

That explosion in testosterone use has occurred despite a lack of evidence showing it is effective. The surge has been attributed to an aggressive marketing campaign by manufacturers alerting men to the potential effects of “low T,” such as fatigue, sexual dysfunction, declining muscle mass and gains in body fat.

“The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone,” said Dr. Christine Nguyen, lead author of the FDA report and the agency’s deputy director of safety.

Typically, a man’s testosterone levels slowly decline with age. And there is a “rough correlation” between that decline and symptoms such as sexual dysfunction, said Dr. Bradley Anawalt, an endocrinologist and professor of medicine at the University of Washington, in Seattle.

But it’s not clear whether “low T” or other factors — such as chronic health conditions, medications or the aging process itself — are to blame. And it’s unlikely, Anawalt said, that men with modestly low testosterone levels would get any benefit from supplements.

What’s more, concerns persist that testosterone supplements increase a man’s risk of heart attack or stroke. Last March, the FDA started requiring all prescription testosterone products to carry a warning about those potential hazards.

Still, the evidence is mixed. One recent study found that men given a testosterone gel were no more likely to develop hardening of the heart arteries over three years, compared to men given a placebo gel that contained no medicine.

The study did not look at rates of heart attack or stroke, however. Only further clinical trials can show whether those risks are real, the FDA says.

There are other issues, as well. For one, Anawalt said, an older man’s testosterone is considered “low” if it falls below the normal range for a healthy young man. There are no standards on normal levels for specific age groups.

“It’s just been assumed that the normal range for young men applies to older men, too,” Anawalt said.

What’s more, FDA research has found that many men do not have any testosterone testing done before getting a prescription for supplements.

And while it is not clear if testosterone is dangerous for men’s hearts, there’s also little evidence that it benefits their well-being, Nguyen pointed out.

The recent study that found no ill effects on men’s heart arteries also found no improvement in sexual function.

Anawalt said that for men with medical conditions that limit testosterone production, it’s “pretty clear” that supplements can be helpful. “The question remains,” he said, “what do you do with the much larger group of men who have ‘low T’ related to aging?”

Based on what’s known, Anawalt said, supplements are “unlikely to do much” for most men whose testosterone dips solely due to age.

More information

The FDA has more information on testosterone supplements.





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