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FDA Approves Implant to Battle Opioid Addiction

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By Dennis Thompson
HealthDay Reporter

THURSDAY, May 26, 2016 (HealthDay News) — A new long-acting implant that can help treat people addicted to heroin and prescription painkillers was approved Thursday by the U.S. Food and Drug Administration.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Dr. Robert M. Califf said in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Probuphine is placed in the upper arm of recovering addicts and releases a steady six-month dose of buprenorphine, an anti-addiction drug designed to combat the cravings that come with opioids like heroin or powerful prescription painkillers like Percocet or OxyContin. Buprenorphine is already available as a pill or a film that can be placed in the mouth.

The steady flow from the implant will reduce fluctuations that can occur when taking a medication once or twice daily, and it removes the need for a patient to remember to take it, said Dr. Annie Umbricht, an expert in substance abuse treatment at Johns Hopkins University in Baltimore.

“A person suffering from addiction would not have to go through the up-and-downs of a daily medication, and therefore will feel much more normal,” Umbricht explained.

Clinical trials published in the Journal of the American Medical Association in 2010 showed the implant led to higher abstinence rates among addicts, with 40 percent remaining drug-free compared with 28 percent receiving a placebo.

People given the implant also were more likely to remain in treatment, about 66 percent compared with 31 percent of the placebo group.

“It really reduces or eliminates cravings, and they don’t start searching around for opiates,” said Dr. Scott Segal, president and chief medical officer of the Segal Institute for Clinical Research in Miami, one of the centers that participated in the clinical trials.

The implant provides patients with no-fail treatment during its six-month period of effectiveness, Segal said.

“Things happen in life,” he said. “You miss your doctor’s appointment, the pharmacy doesn’t have the medication and there’s problems. The implant takes relapse off the table.”

It takes about 15 minutes to place the implant, Segal said, and side effects are similar to oral buprenorphine. They include headache, depression, constipation, nausea, vomiting and back pain, according to the FDA.

“I was concerned that patients would [not] like this option, and I was dead wrong,” he said. “The patients enrolled quickly. They liked it. They tolerated it well. And they were upset when we took them off the implant at the end of the study.”

The United States is experiencing an epidemic of prescription drug abuse, and the new implant could also help counter that, Umbricht said.

There were 28,647 overdose deaths related to heroin and prescription pain killers in 2014, an average of 78 per day, according to the U.S. Centers for Disease Control and Prevention.

That’s because people undergo treatment and lose their tolerance for opioids, but then leave treatment with a high risk of relapse, Umbricht said.

“We know the rate of relapse after drug treatment is more than 90 percent,” Umbricht said. “These people have lost their tolerance, but they don’t realize it. They are at high risk for overdose.”

The implant can help stabilize addicts during treatment, and then provide them with support against relapse once they’ve been released, she said.

Buprenorphine provides effects that are similar to, but weaker than, opioids like heroin or methadone, according to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

But those effects level off at moderate doses, lowering the risk of misuse and addiction, SAMHSA says.

Buprenorphine also interferes with the effects of full-strength opiates, Segal said.

“It tends to saturate the receptors that respond to opiates,” he said. “Even if you were to take opiates with it, you won’t get high. It provides pain relief, but doesn’t give them the buzz or high that heroin would.”

The implant eliminates one other concern associated with oral buprenorphine—the likelihood that someone with a prescription will share their pills with friends.

Researchers estimate that as much as 50 percent of oral buprenorphine prescriptions are “diverted,” Umbricht said.

The intent is most likely to help other people quit their drug habit, Umbricht said, but without drug counseling those addicts are not likely to succeed.

“That person is not going to get the psychosocial support they need,” Umbricht said, adding that drug sharing also maintains illegal behaviors that recovering addicts need to shake.

Addiction specialist Dr. Kevin Cotterell agreed.

“The prospect of a long-acting opiate agonist-antagonist surgically implanted for use in the treatment of addiction to opiates is very encouraging,” said Cotterell, a psychiatrist with South Oaks Hospital in Amityville, N.Y. “It will help in overcoming problems with compliance, which is a great barrier to recovery. It will enhance safety and reduce diversion if used widely.”

More information

For more on buprenophine, visit the Substance Abuse and Mental Health Services Administration.


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FDA Approves Implant to Battle Opioid Addiction

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By Dennis Thompson
HealthDay Reporter

THURSDAY, May 26, 2016 (HealthDay News) — A new long-acting implant that can help treat people addicted to heroin and prescription painkillers was approved Thursday by the U.S. Food and Drug Administration.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Dr. Robert M. Califf said in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Probuphine is placed in the upper arm of recovering addicts and releases a steady six-month dose of buprenorphine, an anti-addiction drug designed to combat the cravings that come with opioids like heroin or powerful prescription painkillers like Percocet or OxyContin. Buprenorphine is already available as a pill or a film that can be placed in the mouth.

The steady flow from the implant will reduce fluctuations that can occur when taking a medication once or twice daily, and it removes the need for a patient to remember to take it, said Dr. Annie Umbricht, an expert in substance abuse treatment at Johns Hopkins University in Baltimore.

“A person suffering from addiction would not have to go through the up-and-downs of a daily medication, and therefore will feel much more normal,” Umbricht explained.

Clinical trials published in the Journal of the American Medical Association in 2010 showed the implant led to higher abstinence rates among addicts, with 40 percent remaining drug-free compared with 28 percent receiving a placebo.

People given the implant also were more likely to remain in treatment, about 66 percent compared with 31 percent of the placebo group.

“It really reduces or eliminates cravings, and they don’t start searching around for opiates,” said Dr. Scott Segal, president and chief medical officer of the Segal Institute for Clinical Research in Miami, one of the centers that participated in the clinical trials.

The implant provides patients with no-fail treatment during its six-month period of effectiveness, Segal said.

“Things happen in life,” he said. “You miss your doctor’s appointment, the pharmacy doesn’t have the medication and there’s problems. The implant takes relapse off the table.”

It takes about 15 minutes to place the implant, Segal said, and side effects are similar to oral buprenorphine. They include headache, depression, constipation, nausea, vomiting and back pain, according to the FDA.

“I was concerned that patients would [not] like this option, and I was dead wrong,” he said. “The patients enrolled quickly. They liked it. They tolerated it well. And they were upset when we took them off the implant at the end of the study.”

The United States is experiencing an epidemic of prescription drug abuse, and the new implant could also help counter that, Umbricht said.

There were 28,647 overdose deaths related to heroin and prescription pain killers in 2014, an average of 78 per day, according to the U.S. Centers for Disease Control and Prevention.

That’s because people undergo treatment and lose their tolerance for opioids, but then leave treatment with a high risk of relapse, Umbricht said.

“We know the rate of relapse after drug treatment is more than 90 percent,” Umbricht said. “These people have lost their tolerance, but they don’t realize it. They are at high risk for overdose.”

The implant can help stabilize addicts during treatment, and then provide them with support against relapse once they’ve been released, she said.

Buprenorphine provides effects that are similar to, but weaker than, opioids like heroin or methadone, according to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

But those effects level off at moderate doses, lowering the risk of misuse and addiction, SAMHSA says.

Buprenorphine also interferes with the effects of full-strength opiates, Segal said.

“It tends to saturate the receptors that respond to opiates,” he said. “Even if you were to take opiates with it, you won’t get high. It provides pain relief, but doesn’t give them the buzz or high that heroin would.”

The implant eliminates one other concern associated with oral buprenorphine—the likelihood that someone with a prescription will share their pills with friends.

Researchers estimate that as much as 50 percent of oral buprenorphine prescriptions are “diverted,” Umbricht said.

The intent is most likely to help other people quit their drug habit, Umbricht said, but without drug counseling those addicts are not likely to succeed.

“That person is not going to get the psychosocial support they need,” Umbricht said, adding that drug sharing also maintains illegal behaviors that recovering addicts need to shake.

Addiction specialist Dr. Kevin Cotterell agreed.

“The prospect of a long-acting opiate agonist-antagonist surgically implanted for use in the treatment of addiction to opiates is very encouraging,” said Cotterell, a psychiatrist with South Oaks Hospital in Amityville, N.Y. “It will help in overcoming problems with compliance, which is a great barrier to recovery. It will enhance safety and reduce diversion if used widely.”

More information

For more on buprenophine, visit the Substance Abuse and Mental Health Services Administration.


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I Refuse to Work Out, but I Do These 4 Things Instead

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I truly hate running. I’ve tried every fitness class my city offers — and living in one of the fittest cities in the country means I have a lot of options. And at-home workouts? The living room in my tiny San Francisco apartment is about as wide as my wingspan. I don’t work out, but I am still the healthiest and most fit I’ve been in my adult life.

I know that fitness means something different for everyone, and I am not saying that working out is something people shouldn’t be doing, either because they want to, because they need to, or both. But when it pertains to my own fitness regime, I can knock it, because I sure as hell have tried it all.

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Growing up, I was active and athletic. I participated in an array of sports — from basketball, track, dance, and gymnastics to swimming, diving, and horseback riding. I was also an active nanny for years, and anyone who has kids or works with them knows that keeping up with two toddlers is more work than running a marathon. I loved it all and never once thought of what I was doing as a workout or as something that I had to push myself to do. Then my focus shifted significantly. No longer was I a high schooler with time to spare and a metabolism the speed of light — I was a determined college student dedicated equally to my GPA and happy hour, and then I was a postgrad professional looking for a job. When was I supposed to be squeezing in a trip to the gym, especially considering the fact that getting myself there was like pulling teeth?

Still, I tried everything to stay healthy and in shape. I bought fitness videos and watched countless online workouts for people who hate working out, for people who live in small apartments, for people who don’t know body balls from barbells. I signed up for individual classes at yoga, barre, and cycling studios, experimented with different gyms, took boxing lessons, and even tried my hand at aerial silks (which were by far my favorite!). Still, nothing quite did it for me. I skipped classes, made excuses, and ultimately felt worse about myself because I simply couldn’t muster the motivation everyone around me seemingly had for fitness.

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What I realized about myself is this: I hate exercise that feels like effort. For me to get a good workout, the results need to be incidental, not intentional, which is why fitness activities that aren’t focused on the workout aspect, but more on the fun, appeal to me most. So I stopped working out. I implemented a few simple things into my daily routine — simple being the operative word here — and I have never felt healthier, more in shape, and happier since letting go of other people’s idea of what fitness should be and instead doing what really works best for me. Here’s how I did it.

I stay constantly active and on my feet.

I am never, ever idle. Seriously, it’s to the point where I risk running into people (and poles) daily because I read while walking through the city. I am constantly on the move, even at work. I get up and down several times an hour and take my laptop to places in the office that allow me to stand (standing desk is next on the list). On the weekends, I make sure to allow myself some downtime with Netflix or a good book, but I don’t waste beautiful, sunny California Saturdays sitting on the couch.

I walk everywhere I can.

I am lucky to live in a place where walking is not only possible but also very practical. I honestly think this is the key to staying in shape for me. I walk everywhere. I have a Fitbit, but my biggest thing about having one is to not let myself dwell on the nitpicky parts of the device. I don’t log every calorie I eat, and I don’t use it to lose weight. I just love challenging myself every day, and having it on my wrist reminds me to take the stairs instead of the escalator and to not waver at the sight of a San Francisco hill but conquer it so that I’m rewarded with an amazing view when I make it to the top. Just this weekend I caught up with my mom on the phone while walking the three miles from my house to Target (totally worth the trek!), then hopped on a bus on the way back home since I had bags. Two birds, one stone.

I eat healthy.

I have a very healthy diet. I eat what I think is probably most similar to a Paleo diet — but I don’t diet. I just try to stick to things that are natural, clean, and not overly prepared, like vegetables, fruits, fish, and meat. I also don’t overeat, mainly because I can’t stand feeling sickeningly full, so I am a huge proponent of multiple small meals throughout the day. It makes the workday go by faster when you get to snack on something every couple of hours, anyway! Sweets aren’t my thing, but I swear by a rare steak every now and then and a postwork glass of red wine. I avoid mixed alcoholic drinks because, to be honest, I can’t stand the sugar, and I drink my coffee black unless I opt for green tea instead.

I make fitness fun.

I’ve stopped pushing myself to go to classes and join a gym, but instead I save my energy for activities that I can get really excited about. I ski, I swim, I dance, and I ride horses any chance I can get. I’m planning my next biking trip across the Golden Gate Bridge, and my last hike took me on a five-hour adventure through a redwood forest in Northern California. I make fitness fun for myself, and in doing so, I’ve learned to love my version of a “workout” so much that I am more in shape than I’ve ever been in my adult life. I am climbing toward my 30s feeling incredibly fit, and what’s more, I’ve finally found a way to stay healthy without hating it.

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The benefits of plyometric exercises

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Plyometrics are great for cardio, toning and fat loss here, we take a look at how the humble plyometric box can be a killer workout session.

“The plyo box has been popular among athletes and hard-core fitness enthusiasts for a while now, but has become more mainstream since the introduction of CrossFit,” says elite trainer of over 15 years Matthew Strickland.

“They are great for cardio-based and high-intensity training, but can also be used for rehabilitative purposes and for evening out physique imbalances.”

Plyometric boxes and aerobic steps come in a range of heights and sizes to adhere to varying fitness levels and exercise goals. While fixed-height boxes are available and usually come in sets of three to four, try opting for a sturdy, adjustable step if you are tight on space. And if you aren’t confident in the jumps, we say go for foam rather than metal or wood versions: a lot less chance of skinned shins.

For cardio/fat loss: Plyometric training involves using explosive bodyweight movements to exert maximum force in the shortest amount of time – making them the perfect fat-burning tool. Explosive movements also mean power and strength, especially in the lower body, can be achieved. Again, keep rest periods short and repetitions as high as possible – although given their taxing nature, sessions shouldn’t go much longer then 30 to 45 minutes. Tip: “When performing box jumps, start in a quarter squat and hinge from the hips to engage the hamstrings and glutes,” says Strickland. “Landings on the box should be soft to help avoid injury.” 

For toning: While plyometric training is renowned for explosive bodyweight movements, Strickland says that there are a range of toning exercises that can be performed simultaneously. “Think anything from single-leg step-ups to incline push-ups using the box,” he says. “The varied range will target muscles you never even knew you had.”

“With proper technique, kettlebells can be used to train your entire body for both toning and fat-burning goals,” says Strickland. “I run a half-hour class and never repeat the same exercise, so boredom is never an issue.”

Compound movements such as the kettlebell swing, in which the centre of gravity shifts, work the entire body while moves native to dumbbell workouts often isolate one or two muscle groups.

“Kettlebells, in my experience, allow people to get deeper into the movements than say a dumbbell,” says Strickland.

For toning:  Kettlebells of varying weights can be used to load isolated muscle groups. When setting up your home gym, opt for a set of light, medium and heavy kettlebells to ensure everything from shoulders to legs can be worked. Strickland’s favourite for a killer lower-body toning session? “I often work some of my favourite kettlebell exercises into a circuit to ensure the muscles are exhausted while also providing a killer cardio and fat-burning workout,” he says. “Try a burpee to kettlebell deadlift to kettlebell upright row. Say no more, this will push your whole body to its limits, and then some.”

For fat loss/cardio: Fat loss and cardio fitness are best achieved through circuit-style training, with limited rest and higher repetitions to ensure the heart rate is elevated for long periods. Strickland suggests high-intensity interval work, with exercises performed for 45 seconds at max reps followed by a short 15-second rest. Sessions should last for about 20 to 30 minutes all up. “Work from the larger muscle to smallest, allowing you to achieve a wider variety of movements. It also means the most taxing, compound movements are completed first,” says Strickland.

NEXT: Looking for more fat loss tips? Check out Alexa Towersey’s here.

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Give Your Loved One a Box of Boxing Goodies to Win the Holiday Season

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Boxing is more popular than ever, and we see it being even bigger in 2017. The Victoria’s Secret models are doing it to prep for the show, and boutiques for fitness-focused boxing are popping up everywhere. With that in mind, we know that boxing gifts will be a big hit this holiday season and have searched far and wide for stylish, comfortable, and practical boxing gear. Your active friend or family member is going to be STOKED.

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The Pull-Up Guide — It's Not as Scary as You Think!

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Despite what you might think, pull-ups are not impossible and can be adjusted for any fitness level. This infamous exercise offers a great upper-body workout that quickly tones the back, arms, and chest. Not only will it make you stronger, but conquering this move will also give an extra boost of confidence and help you feel like you can tackle anything — because, let’s face it, you can.

Beginner Pull-Ups

Assisted Pull-Up Machine: The pull-up machine is a great way to try your first go at pull-ups. The machine uses counterbalance weights, which means the higher the weight you set the machine, the easier the exercise becomes. Start by setting the weight to 20 pounds less than your weight, complete three to five reps, and then adjust the weight accordingly. Here are step-by-step instructions on how to use the assisted pull-up machine at your gym.
Band Pull-Up: With the help of a superband — a giant, two-inch-thick rubber band — you can tackle consecutive pull-ups. All you have to do is wrap the rubber band securely around the pull-up bar, put it under one knee (or one foot for even more assistance), grab onto the bar (stepping off a stool if needed to reach), and begin your pull-up. Superbands are the same length, but the wider the band, the more assistance. Eventually, you will no longer be a “groupie” to the band and will be able to use your body weight!

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Intermediate Pull-Ups

Jump Pull-Ups: Consider jump pull-ups (pull-ups with a jump start) the next level after the assisted pull-up machine. Standing under the bar, jump up to grab the bar, harnessing the momentum of the jump to pull your body and chin to the bar. If your chin doesn’t come close to the bar, don’t give up — this move often takes practice.

Advanced Pull-Ups

Traditional Body Weight Pull-Ups: Using your body weight is the most traditional, but often the most challenging, way to complete a pull-up. With palms facing away from you, grip a pull-up bar with arms extended. Keeping your core tight while engaging your back and lats, bring yourself up until your chin passes above the bar, then lower yourself down into the starting position. The trick (and challenge) to any pull-up is to avoid swinging your entire body or using your neck for added momentum.
Weighted Pull-Up: When you’re ready, let your inner gymnast shine. Following the movements for a traditional pull-up, add a weighted plate for an extra challenge. Using a weight belt or simply holding a weight between your knees, you will be the star of the gym and any workout.

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FDA Issues New Guidelines to Reduce Sodium in Processed Foods

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WEDNESDAY, June 1, 2016 (HealthDay News) — The U.S. Food and Drug Administration wants the food industry to cut back on the salt.

In draft voluntary guidelines issued Wednesday, the agency set both two-year and 10-year goals for lower sodium content in hundreds of processed and prepared foods. The aim is to reduce the risk of high blood pressure, heart disease and stroke among Americans, according to the FDA.

“Many Americans want to reduce sodium in their diets, but that’s hard to do when much of it is in everyday products we buy in stores and restaurants,” Health and Human Services Secretary Sylvia Burwell said in an FDA statement.

“Today’s announcement is about putting power back in the hands of consumers, so that they can better control how much salt is in the food they eat and improve their health,” she added.

Americans’ average salt intake is about 3,400 milligrams (mg) a day, which is nearly 50 percent more than what experts recommend. High salt intake increases the risk of high blood pressure (“hypertension”), heart disease and stroke.

The voluntary targets are meant to reduce Americans’ daily salt intake to 3,000 mg in two years and 2,300 mg in the next decade, according to the FDA. The guidelines cover a wide swath of foods, from bread to cold cuts, cereals, and snacks.

Some studies have estimated that lowering salt intake by about 40 percent over the next decade could save 500,000 lives and nearly $100 billion in health care costs in the United States.

“The totality of the scientific evidence supports sodium reduction from current intake levels,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition.

“Experts at the Institute of Medicine have concluded that reducing sodium intake to 2,300 mg per day can significantly help Americans reduce their blood pressure, and ultimately prevent hundreds of thousands of premature illnesses and deaths,” Mayne said.

“Because the majority of sodium in our diets comes from processed and prepared foods, consumers are challenged in lowering their sodium intake themselves,” Mayne added.

The draft guidelines, which are open for public comment ranging from 90 days to 150 days, were welcomed by American Heart Association CEO Nancy Brown.

“The American Heart Association strongly supports the draft voluntary sodium targets released today by the FDA, and we call upon the agency to finalize them as soon as possible,” Brown said in a statement.

“These new targets will spark a vital, healthy change in our food supply, a change consumers say they want. These voluntary targets can have a significant impact on the nation’s health,” she added.

“Lowering sodium levels in the food supply could eliminate about 1.5 million cases of uncontrolled hypertension and save billions of dollars in health care costs over the next decade,” Brown suggested.

More information

The U.S. Food and Drug Administration outlines how to reduce salt in your diet.


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GMO Crops Don’t Harm Human Health, Report Says

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Genetically engineered crops pose no additional risks to humans and the environment when compared to conventional crops, according to a new report.

The research, published by the National Academies of Sciences, Engineering and Medicine, is the result of a sweeping review of nearly 900 publications on the effects of genetically modified crops on human health and the environment. Genetic engineering has helped agricultural producers in the U.S., including small farmers thrive, according to the report.

But genetic modification is not all good news, the report suggests.Widespread use of genetically modified crops, which are often engineered to resist the effects of pesticides, has contributed to concerning levels of pesticide resistance in weeds and insects. Pests improve in their ability to resist pesticides every time the chemicals are sprayed, creating a vicious cycle of increased spraying and more resistance.

RELATED: Activists Are Restricting a Major Pesticide By Forcing Users to Actually Follow the Label

“There have been claims that [genetically engineered] crops have had adverse effects on human health,” the report says. “Sweeping statements about crops are problematic because issues related to them are multidimensional.”

Researchers behind the report called for a process that evaluates potential health and environmental concerns about new type of crops regardless of whether they are genetically engineered.

The report comes as public health and environmental advocates continue to push for mandatory labeling of genetically modified food. The results of the National Academy report suggest that such measures may not be necessary. Report committee member Michael Rodemeyer said at a press conference that without evidence of health effects from GMO crops, the Food and Drug Administration does not even have the authority to mandate such labels.

RELATED: The GMO Controversy Misses the Point

But the report is unlikely to stop calls for labeling that have already succeeded in some states, such as Vermont, and led some food manufacturers like Whole Foods to promise to curtail their use of genetically modified ingredients. Report authors acknowledged that their report would not—and should not—settle the debate over GMOs.

“We’re hoping that our report is not this big tome but something that starts a conversation,” North Carolina State University professor Fred Gould, who chaired the committee behind the report. He also hoped the findings would help fuel an evidence-based discussion rather than a heated back and forth between. “It would nice not to have a debate, but maybe an eight-hour discussion,” Gould added.

This article originally appeared on Time.com.

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