It tears every part of your life away: the truth about male infertility

Men are facing a fertility crisis, so why is most practical and emotional support offered to couples struggling to conceive aimed at women?

James and Davina DSouza met and fell in love in their early 20s. They got married five years later, and three years afterwards had saved enough to buy a family home in a quiet cul-de-sac in London. Then, when Davina was 29 and James 33, they started trying for a baby.

I knew that the moment we bought a home, wed start a family, Davina tells me in their living room, beside shelves crammed with framed photos of nieces, nephews, cousins and siblings. My parents live down the road, and if I needed help to raise a child, my mum would be here.

We thought about all of that stuff, James adds. The job, the future, the house, the home: we make things happen.

But after a year of trying, nothing had happened. Davina went to their GP, who referred her for the kind of invasive tests that have become the norm for women who experience problems conceiving: she had an internal, transvaginal scan to check her womb for fibroids, and an HSG test, where dye was pushed into her fallopian tubes to see if they were blocked. Everything looked normal.

It was only then that anyone suggested testing James. He had his semen analysed, and was told that only 1% of his sperm were formed normally. Still, it only takes one, the consultant said. She told them not to worry and to carry on trying. Two years after Davina came off the pill, James was tested again. This time, he had no normally formed sperm at all.

My first thought was, Oh, its my fault, James says, quietly. He stares at the coffee table through his thick-framed glasses. I felt helpless. No one was talking about this stuff. Youd go online and there was no male conversation. Id Google problems having a baby or fertility issues, and the websites that came up were all pink. Id post in a forum and women would respond on behalf of their husbands. There was nothing for men.

Though he may have felt it, James is not alone. Across the western world, men are facing a fertility crisis. A landmark study by the Hebrew University of Jerusalem, published in July, showed that among men from Europe, North America and Australia, sperm counts have declined by almost 60% in less than 40 years. Fertility specialists have described it as the most robust study of its kind (the researchers came to their conclusions after reviewing 185 previous studies involving 43,000 men from across the globe) and the findings are stark. Such a significant decline in male reproductive health over a relatively short period in such a specific population suggests theres something in the way we live now that means its much harder for men to become fathers than a generation ago.

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Until recently, the focus of both fertility experts and research scientists has been overwhelmingly on womens bodies, while male reproductive health has been almost ignored. For decades, the average age of both fathers and mothers has been increasing, but its women who have felt the pressure of balancing the need to invest in their careers with the so-called timebomb of their own declining fertility. They have been encouraged to put family first and to change their lifestyles if they want to become mothers, at the same time as male fertility appears to have fallen off a cliff.

Davina says the consultant gynaecologist who was treating her and James had no hesitation about next steps. She said, Jamess sperm results are in, and we think you should go for IVF. That was it. The NHS didnt have any other options for us. Indeed, the NHS couldnt even fund any IVF in their area at that time, so they had to scrape the money together to go private. They spent more than 12,000 on two rounds of IVF, and were finally offered a third round on the NHS this year. But after nearly seven years of trying for a baby, they are still childless.

IVF takes a huge physical, hormonal and emotional toll on a woman, James tells me. Sometimes I felt totally powerless, ineffective. I questioned my masculinity, my sense of myself as a man, through those rounds of IVF. During consultations, James felt the conversations were always directed at Davina. I felt like I had to say, Im here. Id deliberately ask a question to make my presence felt.

On their first round of IVF, someone at the clinic recommended James take a vitamin supplement. It was the first time lifestyle factors had been mentioned. That was when I realised, maybe there is something I can do, he says between slurps of his own blend of bulletproof coffee (made with grass-fed butter, coconut oil and egg yolk). James, head of sixth form at a local school, is a fan of self-help books. Hes been on a high-fat, low-carbohydrate ketogenic diet for months and says its done him good: hes slim and spry, but says he wasnt always this way. Hes wearing a digital fitness tracker. But as someone who rarely drinks, has never smoked and doesnt ride a bike, there were few lifestyle changes he could make, beyond taking colder showers and wearing looser underwear. Still, his sperm quality has improved.

At the moment, the couples fertility problems are unexplained. They decided against adoption when social workers said theyd have to use contraception during the process, because it wouldnt be fair on an adopted child to move into a home with a new baby, and they arent prepared to stop trying just yet.

Weve talked about when were going to call it a day, James says.

Davina glances at him with wet eyes. It makes me sad to think well be putting a cap on it.

But it regularly comes up, he says. We did actually say at the end of this year well stop. Ive been asking, Why do we want to have children? Weve decided it isnt going to define us.

There is treatment for male infertility, but its certainly not in the fertility clinic, says Sheryl Homa, scientific director of Andrology Solutions, the only clinic licensed by the Human Fertilisation & Embryology Authority to focus purely on male reproductive health in the UK. Men are channelled from their GP with a semen analysis and sent straight to a gynaecologist in an IVF clinic. But gynaecologists are interested in the female reproductive tract.

A former clinical embryologist, Homa once led IVF laboratories in both the private and public sectors. I was quite horrified by the lack of investigation and appropriate management of male infertility, she says, so I decided to start my own clinic specifically to focus on male fertility diagnosis and investigation. Male reproductive health is being assessed through semen analysis, which she argues has a very poor correlation with fertility. Instead of having their detailed medical history taken and a full physical examination, men are being given a cup and asked to produce a sample.

Homa says the leading cause of male infertility (around 40%) is varicocele (a clump of varicose veins in the testes). It can be determined from a physical exam, and can certainly be ruled out by an ultrasound scan. All women get ultrasound scans; why arent men getting them?

Varicoceles can be repaired by fairly simple surgery under local or general anaesthetic, leading to a significant improvement in a couples chances of successful natural or assisted conception. But many are going undiagnosed. The NHS is carrying out far too many IVF treatments when they could be saving money by doing proper investigations in men.

Homa says there is also some evidence linking silent infections those with no symptoms, such as chlamydia in men with delayed conception and an increased risk of miscarriage. But if a man is judged by his semen sample alone, there would be no way of addressing these hidden concerns.

Apart from saving the NHS money, there are important medical reasons why men should be thoroughly examined, Homa argues. Semen parameters are a marker of underlying systemic illness: they might have diabetes, they might have kidney disease, they might have cardiac problems. It could be something much more serious thats contributing to the problem.

As for the possible reasons for falling sperm counts across the west, Homa mentions all the chemicals and pesticides that we are exposed to in our environment, as well as smoking, rising levels of obesity and increasingly sedentary lifestyles. But at the moment, ideas such as these including hormones in the water and BPA in plastics that might mimic the effect of oestrogen inside the body are just theories that make intuitive sense. In the absence of widespread research over time, no one can pinpoint exactly which factor or combination of factors is making the difference.

In the 10 years her clinic has been operating, Homa has seen demand for her services steadily rise. She says she gets the fallout from men whove been sent by their GP for multiple rounds of fertility treatments that fail, when IVF should be the last resort. But at the moment, National Institute for Health and Care Excellence (Nice) guidelines give GPs no option but to refer men with fertility problems to IVF clinics. If theres a female problem, the GP will refer them to a gynaecology clinic. If theres a male problem, they need to be referring to a consultant urologist who deals with male infertility. But its just not happening.

Gareth
Gareth Down and his wife, Natalie, went through 10 rounds of IVF before their son, Reece, was born. Photograph: Harry Borden for the Guardian

In some ways, Gareth Down and his wife, Natalie, were lucky: they knew from the start that their problems conceiving were probably down to Gareth, because he had had surgery to remove benign lumps on his testes as a teenager, and always feared they might interfere with his chances of becoming a father. But after 10 cycles of IVF that cost them tens of thousands of pounds, and several miscarriages, lucky doesnt feel like the right word.

I always wanted kids, says Gareth, 31. My mum was a childminder, and I was brought up looking after kids, so from as young as I can remember, weve had a house full of them. He and Natalie started trying for a baby six months before their wedding in 2010, and went to the GP a year later, when nothing had happened. Gareth was referred to a urologist, who confirmed that the surgery hed had as a teen had affected his sperm production, and that he had azoospermia: a zero sperm count.

The Downs were determined to have children, but trying almost broke them. It invades every part of your life, Gareth says. On a personal level, you have to confront the fact that you might not have a family. It affects you financially, as you try and save to fund the treatment. We had family fallouts because we couldnt see newborn nieces and nephews we just couldnt be around babies. We changed jobs because time off with certain employers was difficult. I had quite a customer-facing job at one point, and when they were telling me about their problems, I was thinking, You aint got problems. He pauses. I dont think there was any part of who we were that we held on to by the end. It tears just about every part of your life away.

Gareth has just put his 16-month-old son, Reece, to bed while Natalie is still at work. Reece was conceived with donor sperm, on their 10th round of IVF, when Natalie had had enough of the heartache of fertility treatment and was convinced they should give up. After going through so much to have him, their first feeling when Reece was finally born was not joy, but disbelief. It was surreal, says Gareth. I dont think either of us could accept it was real and going to last. Wed had so many ups and downs that we couldnt believe nothing bad was going to happen. We kept checking the cot to see if he was still there. It was weeks before we realised he was not going to be taken away from us.

It was during their final attempt to have a baby that Gareth set up his closed, men-only Facebook group, Mens Fertility Support. Over the years, Natalie had found a lot of comfort online, from forums and support pages to Facebook groups, and was surrounded by an international community of women going through the same experience. Gareth had tried to contribute in the same places, but never stuck around long. There were no other men there to relate to what you were saying, or make you feel you could say what you meant and that it wouldnt be taken the wrong way by an audience that vastly outnumbered you.

The 300 or so members of his group are a diverse mix of men, mostly from the UK. Some are just beginning to have problems with conception, others went through it decades ago; some never had a happy ending and are there to share their experiences that a life beyond trying to have a family is possible. Many members say its the only place they can be totally honest: the belief that the ability to father children is a marker of masculinity has left many unwilling to talk about their issues anywhere else.

We do get women wanting to join, Gareth tells me with a smile, but we want a degree of privacy. Its about having freedom to talk, to say, yes, those [IVF] hormones really do screw her up and its really tough. You need to be able to vent somewhere without causing offence to anyone you know.

Everyone Gareth and Natalie told about their problems conceiving assumed the issue must be hers. Every step of the way it was, Poor Nat whats going on with her? But he hopes that men are starting to seek help. If it was any other part of your body that wasnt working properly, youd seek advice. Slowly, those barriers are beginning to come down a bit.

He wonders whether the new figures on declining sperm counts could have been coloured by this growth in awareness: fertility treatments are more in demand than ever, so more men are having their fertility investigated. Are we just testing more, looking into things more? he asks. If you had fertility problems 40 years ago, you wouldnt have wanted to confront it or had anywhere to go with it.

Dr Xiao-Ping Zhai, the fertility specialist behind the Zhai Clinic, agrees. We never really tested men in the past, and if you use the word decline, you have to have something to compare it to. In the past, people probably had problems, didnt want to say they had problems, and didnt have children. Even though the Hebrew University of Jerusalem study is the best piece of research weve had so far, she points out, the data from 40 years ago is still very thin.

Trained both in western and traditional Chinese medicine, Zhai has a unique perspective on fertility treatment and, since she opened her Harley Street clinic more than 20 years ago, claims shes had a great deal of success in helping couples conceive even though many patients come to her out of desperation rather than faith in traditional medicine. Its mainly women who call to make the appointments. Eighty per cent of the time, the partner doesnt even want to come along. They dont think they have a problem.

Rather than look at sperm counts, Zhai takes a full health MOT of all her patients, using diagnostics from Chinese medicine to find out which part of the body needs to be addressed: You find that a lot of people have something that cant be discovered on a scan or through mechanical investigation what wed call a functional problem. Zhai offers a range of treatments according to the patients specific constitution, including acupuncture, herbal supplements and advice on lifestyle changes and diet. None of this is cheap: an initial consultation costs 250, and a four-week course of bespoke herbal supplements can cost up to 350.

But IVF treatment on Harley Street costs even more, and Zhai says many of her patients arrive in the consulting room having already spent lots of money. Its to do with the culture here: in the UK, if a man has a problem, then the woman needs IVF. IVF clinics can offer only what they specialise in.

In 2014, Zhai launched a national campaign to end the stigma attached to male infertility and improve the treatment choices offered to men. She called for a full parliamentary debate on male fertility issues, and on health secretary Jeremy Hunt to work with doctors to improve practice and treatment pathways for men within the NHS. But there has been no debate and no change in NHS strategy. There are too few options for infertile patients, Zhai says. It will take a long, long time to overcome this culture.

Gary
The doctor who rang with Gary Parsons sperm count results simply said it was game over. Photograph: Harry Borden for the Guardian

Gary and Kim Parsons went to their GP two years after Kim stopped taking the pill, when there was still no sign of pregnancy. She went through all the regular tests blood tests and then more invasive examinations and everything came back A-OK, says Gary, 36, from his home in Burnham-on-Sea. Then it was my turn. Like James, Gary had no physical examination and was asked only to produce a sample to check his sperm count. That came back as a big fat zero. There was nothing to count.

When the doctor rang to deliver the results, he said it was game over. Gary blinks in disbelief when he tells me this. I really didnt need any encouragement to feel more down about things, so that was an unfortunate turn of phrase. Gary thinks this may have been because it was a conversation between men. That extreme, direct way of communicating might have been the only way he thought he could get me to understand that this is not something where I could drink a kale smoothie and everything would be OK.

Still, thats what Gary tried, at first. Or, rather, he turned to vitamin supplements and a high-protein diet in the hope they could help. Im a vegetarian, so for a second I thought, Oh no, Im one of these anaemic, lentil-based stereotypes. But, ultimately, he knew this probably wouldnt help because his count wasnt low it was zero. There was nothing to improve. Thats the thing Ive found hardest. Most problems Ive had in my life Ive overcome with either bloody-mindedness or effort, and thats not this, he says, shaking his head. Thats not this.

Garys infertility remains unexplained. The next step is for him to have a testicular sperm extraction procedure, to find out if hes producing sperm that are being blocked, which could potentially be extracted for use in assisted conception. Three years after they started trying for a baby, this will be the first time he will be examined beyond blood tests and semen samples.

Without Gareth Downs Facebook group, it would have been hard to find someone to talk to. Gary is a counsellor, and when he looked at who was registered with the British Infertility Counselling Association, the professional body for fertility counsellors in the UK, he found that the 46 registered practitioners were all women. Emotional support provision for men is glaring in its absence, he says. Its just a case of, On your bike, son. Get on with it.

The way that men are treated as the secondary partner in infertility treatment could have worrying consequences, he says. All the paperwork goes through the female. Everything is done through my wife. In meetings, its been very rare that Ive even been able to get any eye contact from a consultant so far. It occurred to me that, should my wife leave me, I would have no mechanism for resolving this, or getting any questions answered, and that would have an impact in terms of maybe meeting someone new, or even knowing if Im able to be a parent one day.

Edinburgh University professor Richard Sharpe, an expert in sperm count and male fertility, believes the University of Jerusalem studys findings should be taken very seriously. If something is having that big an effect something in our environment, diet, lifestyle, and we dont know what it is what else might it be doing to us? We think of sperm counts as a fairly crude barometer of overall male health. Its a warning shot across our bows.

Sharpe has been specialising in male infertility for 25 years, but even he can offer only general hypotheses about what could have made sperm counts fall by 60% in little over a generation. He thinks diet and lifestyle are much more likely to be contributory factors than environmental chemicals such as pesticides, plastics and hormones in the water, because the evidence that they could induce such striking effects at low levels of exposure is unconvincing. But our understanding of the normal process of sperm production is very poor, completely superficial, he says. Its a much more complex process to understand than the menstrual cycle, and we havent done enough research.

There is a chance that women might ultimately be behind the sudden drop in sperm count, Sharpe believes. His work has looked at the link between rates of maternal smoking and the use of painkillers during pregnancy, and the reduced sperm counts of sons in adulthood. A baby boys testes are formed during the first trimester, when many women dont know theyre pregnant, and the period immediately after their formation is critical for the production of testosterone. What we are seeing now could be the expression of a generational problem: the fact that, since the 1970s, women are more likely than ever to smoke and take over-the-counter painkillers.

But, again, the evidence isnt strong enough. There are four studies that all show a significant association between maternal smoking and reduction in sperm counts in male offspring, so its plausible, he says, but it cant explain the 60% fall, because not so many women smoke and smoke heavily. A longitudinal study, over 20 years, would be needed to demonstrate the effects of maternal lifestyle on male fertility, but long-term research projects are inherently difficult to get funding for, unless public bodies think the issue is critically important. Male fertility is not considered a high-priority issue, partly because theres this perception that its a problem solved by assisted reproduction. Thats not treatment of the underlying issue behind male infertility. Its simply ignoring it.

We may be sleepwalking into a future where we become increasingly dependent on assisted reproduction, Sharpe argues, without fully understanding the long-term consequences of the technologies were relying upon. Researchers have already demonstrated in animals that its possible to make sperm out of other kinds of cell. People are going to do this in humans not in the UK, initially, but they will somewhere in the world. Those techniques are going to be applied in the fertility clinic, but we dont have the knowledge to do it in a truly informed way, to know that its all safe, that there are no consequences.

Whatever the reasons for our underinvestment in male fertility lack of funding and research, male pride or the overemphasis on women in fertility treatment it has huge implications for both men and women. Were flying blind to a large extent, and so far weve been ridiculously lucky, Sharpe says. Its a perfect storm, at every level.

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Read more: https://www.theguardian.com/lifeandstyle/2017/nov/18/tears-every-part-life-truth-male-infertility-ivf

What sets apart the ‘Biggest Losers’ who keep off the weight

(CNN)After competing in “The Biggest Loser,” many of the reality-show contestants have reluctantly regained the weight they sought to lose through extreme dieting and exercise.

“The truth is, I kind of spiraled,” Ali Vincent, the first woman to win the competition, told Oprah last year. “I got home and I was like, ‘What do I do?’
“I’m supposed to be strong. I’m supposed to know how to do this.”
    But some contestants discovered for themselves the key to keeping their weight down long after the cameras turned off, according to a study published Monday.
    Six years after appearing on the show, a group of 14 contestants had kept off a median 13% of their original body weight. The researchers split the group in two — the “maintainers,” who had kept a substantial amount of the weight off,and the “regainers,” who did not — and looked at what set them apart.
    “Did they cut more calories from their diet … or did they become more physically active?” asked study author Kevin Hall, a senior investigator with the National Institute of Diabetes and Digestive and Kidney Diseases.
    Hall had been “puzzled by how quickly the contestants were losing weight.” So he contacted the show’s physician and began studying the season eight contestants.
    Early on, Hall observed that weight loss was better predicted by food intake, not physical activity alone. But in the long term, the opposite was true.
    “You have to be very physically active in order to keep the weight off,” Hall said.
    The “maintainers,” who kept off about 25% of their preshow weight on average, increased their physical activity by roughly 160% from before the competition. Those who regained the weight increased their activity only 34%. They were 1.1% heavier on average than their original weight.
    The researchers couldn’t find any major differences between the food intake of both groups; both cut their calories by about the same amount.
    “While we know that the most important aspect of helping one lose weight is the dietary intake, that is pretty much reversed when it comes to weight loss maintenance,” said Dr. Jennifer Kraschnewski, associate professor of medicine and public health sciences at the Penn State College of Medicine. She was not involved in the study.
    Hall’s findings echo previous studies that promote more exercise for long-term weight loss maintenance. However, experts caution that doesn’t mean people can neglect their diets in the long run, either.
    To maintain the weight loss, Hall’s team estimated that contestants would need to engage in 80 minutes of moderate activity or 35 minutes of vigorous activity each day beyond what they were doing at baseline.
    This is far beyond the leading guidelines for physical activity from groups like the American Heart Association and the US Centers for Disease Control and Prevention, which “are far too low for maintaining weight loss,” Hall said.
    The researchers didn’t observe the contestants working out directly. They used tools like traceable water molecules to figure out how much energy was expended — the “gold standard” measurements in this type of research, Kraschnewski said. Many larger studies have instead asked people to self-report how much they exercised, which can be riddled with errors.
    This method, however, was not able to tell how much of the physical activity was due to normal daily activities — like cleaning the house or walking the dog — versus following a workout plan, Hall said.
    Part of the reason the contestants’ weight rebounded was because of “metabolic slowing,” Hall said. As contestants lost weight during the competition, their bodies burned fewer calories than expected.
    “This can make it more difficult to lose weight and is another hurdle to overcome,” Kraschnewski said. After going on a very low-calorie diet, “the body’s mechanisms kick in to preserve body mass at all costs.”
    Six years later, however, the contestants’ resting metabolisms still hadn’t sped back up, Hall showed in a study last year.
    This is a stark difference from people who have had gastric bypass surgery for weight loss, whose metabolisms may speed back up in a year’s time, Kraschnewski said. Researchers are trying to figure out why this is — and it may have something to do with the intricate connections between the gut, brain and hormones that regulate hunger, Kraschnewski added.
    For Hall, metabolic changes are just one part of the puzzle. Genetics may also play a role, as well as social factors that can make it hard for some people to incorporate so much exercise in their daily lives.
    “To do that requires a huge investment of time and energy,” he said. “The bar is set very high for those folks to be able to maintain the weight loss without surgery or drugs.”

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    Hall added that it’s not necessarily those who were most physically active during the competition who kept it up six years later.
    “You can’t really reproduce the expectation that those individuals must have had on the show to lose weight — the pressure,” Kraschnewski said.
    “The take-home point here is that obesity really is a disease,” she said. “It’s not something that you can treat once and will cure it. It’s something that has to be continually addressed in one’s life.”

    Read more: http://www.cnn.com/2017/11/03/health/biggest-loser-diet-exercise-study/index.html

    Sugar and cancer: Is there a link?

    (CNN)Does sugar, which makes all things delicious, lead to cancer?

    A biologic mechanism in yeast cells may explain the relationship between sugar and malignant tumors, according to a recent study published in the journal Nature Communications.
    The nine-year research project may even influence personal medicine and diets for cancer patients, the authors concluded. The study begins by looking closely at cancer cells’ appetite for sugar.
      Scientists understand that cancer cells support their rapid reproduction by rewiring their metabolisms to take glucose, ferment it and produce lactate.
      Conversely, healthy cells continue with normal respiration, a process in which they take glucose and break it down into carbon dioxide and water.
      This “switch of cancer cells from respiration to fermentation is something that was discovered by Otto Warburg, a German biochemist, about 70 or 80 years ago,” said microbiologist Johan M. Thevelein, senior author of the study and a professor at KU Leuven in Belgium. It is known as “the Warburg effect.”
      Fermentation of sugar to lactic acid produces about 15 times less energy than respiration of sugar, Thevelein noted. Yet cancer cells “grow much more rapidly than normal cells, and yeast actually grows the fastest when they ferment,” he noted.
      “This is weird,” he said, and it raises an important question: Is the Warburg effect a symptom of cancer — or a cause of it?
      Searching for the answer, Thevelein and his colleagues experimented with yeast cells since, just like cancer cells, they are known to favor fermentation over respiration.
      The researchers found an intermediate compound that is a “potent activator” of the RAS protein. RAS is a proto-oncogene: a gene that codes for proteins that help to regulate cell growth and differentiation. Proto-oncogenes can become oncogenes or cancer-causing genes when mutations occur. Mutant forms of RAS proteins are present in many tumors, Thevelein said.
      The new study, then, reveals “a vicious cycle,” he said.
      As sugar is broken down in cells, the intermediate compound activates the RAS proteins, and this in turn stimulates cell proliferation, he said.
      This cycle seen in yeast cells might help explain the aggressiveness of cancer.
      “Very interesting,” said Dr. Jennifer Ligibel, chairwoman of the American Society of Clinical Oncology’s energy balance committee. Still, she urges caution in interpreting these findings.
      “It’s important to not make too many jumps into a patient message based on a study of yeast,” she said.

      Eating sugar or too much weight?

      Even though the researchers pinpointed some similarities between yeast and human cancer cells, Ligibel explained, “it’s important to recognize we’re a few steps away from even human cancer cells in a test tube.”
      The study showed only an increased rate of cell growth triggered by glucose, she said. Even though the team showed RAS pathways being activated, this “actually didn’t result in the cells replicating more quickly,” she said.
      Still, the data are “incredible,” said Ligibel, who is also an associate professor of medicine at Harvard Medical School. “This is really one of the first studies that’s provided a biologic mechanism that could explain a relationship between glucose itself and cancer progression.
      “When we think about the relationship between sugar and cancer — when we think about what drives the level of sugar in someone’s body — it’s primarily related to their weight,” Ligibel said.
      When people are heavier, their bodies manage sugar differently than those of people who are lighter. This sugar management is what leads to type 2 diabetes, a disease in which blood sugar is high and levels of insulin, the hormone the body uses to manage blood sugar, begins to rise because the body becomes resistant to its effects.
      “We’ve known for a while that having a higher blood sugar and having a higher level of insulin in your system are both linked to the risk of developing cancer,” Ligibel said.
      At the same time, studies that have tried to look at how eating sugar might be linked to cancer risk “have been much less consistent,” she said. One large study of older US adults, for instance, did not find a relationship between the amount of sugar people ate and the risk of developing cancer.
      Conversely, she noted, other studies show that people diagnosed with colon cancer who ate a higher proportion of their total calories in sugar had a higher risk of cancer recurrence — but only for people who were already overweight and obese. Once again, how the body manages sugar — and not the sweetener itself — may be key.
      Studies in breast cancer patients have compared low-carbohydrate diets to low-fat diets and found that the amount of weight people lost, not the diet itself, was important, Ligibel said. If it led to weight loss, either diet brought an identical lowering of sugar in the blood stream and an identical lowering of insulin.
      “Whether you achieved that through one diet versus another didn’t seem to be as important as the amount of weight you lost if you were overweight or obese,” she said. Translated into practical advice for cancer patients: “If you have someone who is obese or overweight, helping them to lose weight is going to be an important thing. We know that from a lot of different lines of study.
      “I think that sugar definitely contributes to weight gain. I think that sugar doesn’t have a lot of nutritional value,” Ligibel said. Still, cancer patients need to focus on maintaining a healthy weight by balancing exercise and the food they eat.

      Sugar can cause obesity which leads to cancer

      Asked whether he believes that eating more sugar leads to more cancer, Thevelein immediately answered, “No! definitely not.” He and his co-authors do not state that in the paper; instead, they explain how normal, healthy cells can handle sugar in a controlled way.
      “On the other hand, we all know that when you eat a lot of sugar, you have a tendency — that has been clearly shown — to become more obese,” Thevelein said. “And obesity is linked to a higher risk of cancer.”
      Though it’s “too early to say,” Thevelein said that when you eat too much sugar over a long time, “maybe this can also lead in some way to dysregulation of the RAS protein in the normal cells,” and possibly it is this “dysregulation” that triggers RAS genes into becoming mutants.
      “It’s better not to eat too much sugar so that you don’t become obese,” he said. “And if at the same time, you also decrease your risk of cancer, the better — but this is something we cannot make a statement about at this moment.”

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      If anything, he would suggest that cancer patients eat less simple sugars and more complex sugars, such as those found in starch and whole grains. Complex sugars are released more slowly and are taken up by the body more slowly, and this might be helpful to cancer patients.
      “That would be our message,” Thevelein said: “Try to look for alternative ways of providing sugar and energy to cancer patients rather than rapidly metabolized simple sugars.”

      Read more: http://www.cnn.com/2017/10/27/health/sugar-cancer-relationship-study/index.html

      Why Type A people often struggle with weight loss programs

      (CNN)Type A personalities are known for being punctual, all-in, organized, competitive and rule-following.

      These qualities also mean they can get frustrated with mainstream diets and workout programs when they don’t work.
      The problem is that weight loss programs have a one-size-fits-all structure to appeal to the masses. So for Type As committed to a program and following it diligently but frustrated by failure, it may be the program that’s a failure, not them.
        But you can also harness the psychology of a Type A personality to turn diets and workout frustrations and failures into successes. Consider three areas of opportunity.

        The all-or-nothing approach

        This is a classic mindset for Type A personalities: You’re either all in, or you’re all out. If you’re getting sick or feeling tired, you’ll work out no matter what, because that’s what the program says. If you’re on a strict diet but it’s your birthday, you’ll avoid cake at all costs.
        But the problem with this approach is that you’ll feel ultra-restricted and be more likely to go overboard next time.
        Therefore, you need to build some flexibility into the rules.
        Are a few bites of cake really going to derail your diet? No. So instead of feeling like one little misstep will derail you, build confidence that you know what’s best for you and that your diet is simply an outline, not the law.
        If you are intensely committed to exercise and don’t leave room for feeling sick or tired or wanting to change the workout you had scheduled, it can lead to burnout. If you’re not getting enough sleep to wake early and work out, you are probably better off sleeping in a few days a week and doing fewer workouts.

        Really intense workouts

        Sometimes, a long or intense workout can seem intimidating. However, if you’ve got a Type A personality and you’re committed to a weight loss program, these workouts may seem non-negotiable! But sometimes, you’re exhausted or your body is too sore from a previous workout. A break is needed, and it can be too taxing on the body to follow a regimented workout plan every single day.
        Again, leave room for flexibility and changes to your workouts. Instead of doing an intense spinning class because that’s what was on the schedule, allow yourself the freedom to choose a more relaxing yoga class instead. If you run out of time to do a 45-minute workout at the gym without feeling frazzled and rushed, make a deal with yourself that you’ll do a 15-minute ab routine in your living room instead.
        Sometimes, the commitment to intense workouts doesn’t allow us room to connect with how we feel and what we know is best for our bodies, so taking a moment to assess our feelings is key to sticking to a program long-term.

        Avoiding social gatherings

        If you’re following a rigid weight-loss program, going out to eat can cause a lot of anxiety.
        Will you be tempted by food off your plan? Will others comment about your eating habits? Will the chef cook your food correctly (light sauce, light seasoning and grilled rather than fried, please)? Although these are valid concerns when you’re on a healthy eating plan, they don’t have to cause you to become a hermit. Food programs can always be adapted for your own individual needs.
        For example, if you’re going a friend’s house, eat something that’s on your food plan before heading over, and then pick and choose what you’d like to eat once you’re there. Arriving full will decrease your likelihood to overeat foods that aren’t on your plan.
        Similarly, when you’re out to eat at a restaurant, pick foods that are on your plan, and don’t stress too much about the specifics, like how the protein or veggies are cooked or what sauce is on them. You can ask for light sauce or no sauce, or to sub vegetables for mashed potatoes, for example, but avoiding eating out altogether would make anyone go crazy!

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        The benefits of having a Type A personality include finding security in the structure and rigidity of diet and workout programs, but this personality type also needs to allow room for flexibility and changes. Just because you go off the course of one particular program doesn’t mean you’ve gone off-course altogether.
        Making choices that align with how you feel and what you want for yourself is a top priority and is essential to being successful while engaging with a specific and formulated weight loss program.

        Read more: http://www.cnn.com/2017/10/23/health/type-a-weight-loss-fitness-mansour/index.html

        Dyslexia: scientists claim cause of condition may lie in the eyes

        In people with the condition, light receptor cells are arranged in matching patterns in both eyes, which may confuse the brain

        French scientists claim they may have found a physiological, and seemingly treatable, cause for dyslexia hidden in tiny light-receptor cells in the human eye.

        In people with the condition, the cells were arranged in matching patterns in both eyes, which may be to blame for confusing the brain by producing mirror images, the co-authors wrote in the journal Proceedings of the Royal Society B.

        In non-dyslexic people, the cells are arranged asymmetrically, allowing signals from the one eye to be overridden by the other to create a single image in the brain.

        Our observations lead us to believe that we indeed found a potential cause of dyslexia, said the studys co-author, Guy Ropars, of the University of Rennes.

        It offers a relatively simple method of diagnosis, he added, by simply looking into a subjects eyes.

        Furthermore, the discovery of a delay (of about 10 thousandths of a second) between the primary image and the mirror image in the opposing hemispheres of the brain, allowed us to develop a method to erase the mirror image that is so confusing for dyslexic people using an LED lamp.

        Like being left- or right-handed, human beings also have a dominant eye. As most of us have two eyes, which record slightly different versions of the same image, the brain has to select one of the two, creating a non-symmetry.

        Many more people are right-eyed than left, and the dominant eye has more neural connections to the brain than the weaker one. Image signals are captured with rods and cones in the eye the cones being responsible for colour.

        The majority of cones, which come in red, green and blue variants, are found in a small spot at the centre of the retina of the eye known as the fovea. But there is a small hole (about 0.1-0.15 millimetres in diameter) with no blue cones.

        In the newstudy, Ropars and colleague Albert le Floch spotted a major difference between the arrangement of cones between the eyes of dyslexic and non-dyslexic people enrolled in an experiment.

        In non-dyslexic people, the blue cone-free spot in one eye the dominant one, was round and in the other eye unevenly shaped. In dyslexic people, both eyes have the same, round spot, which translates into neither eye being dominant, they found.

        The lack of asymmetry might be the biological and anatomical basis of reading and spelling disabilities, said the studys authors.

        Dyslexic people make so-called mirror errors in reading, for example confusing the letters b and d.

        For dyslexic students their two eyes are equivalent and their brain has to successively rely on the two slightly different versions of a given visual scene, they added.

        The team used an LED lamp, flashing so fast that it is invisible to the naked eye, to cancel one of the images in the brains of dyslexic trial participants while reading. In initial experiments, dyslexic study participants called it the magic lamp, said Ropars, but further tests are required to confirm the technique really works.

        About 700 million people worldwide are known to have from dyslexia about one in 10 of the global population.

        Read more: https://www.theguardian.com/society/2017/oct/18/dyslexia-scientists-claim-cause-of-condition-may-lie-in-the-eyes

        Regular marijuana users have more sex, study says

        (CNN)Dr. Michael Eisenberg, an assistant professor of urology, sees a lot of patients at the Stanford University Medical Center who have problems performing in the bedroom.

        To determine what the problem is, they’ll go through a laundry list of regular activities. Often, patients will ask whether they need to smoke less marijuana.
        There isn’t a lot of research on the topic. However, with marijuana becoming legal in a growing number of states, Eisenberg thought it’d be worth exploring.
          What he found surprised him.
          “Usually, people assume the more frequently you smoke, the worse it could be when it came to sex, but in fact, we learned the opposite was true,” Eisenberg said. His study was published in this week’s Journal of Sexual Medicine.
          The study looked at data from the US government’s National Survey of Family Growth. It asked more than 28,000 women and nearly 23,000 men how often they had sexin the four weeks prior to the survey and how frequently they used marijuana in the past year.
          Women who didn’t use marijuana reported having sex six times on average during the past four weeks. Women who used marijuana daily had sex 7.1 times on average.
          The trend was similar for men. Men who abstained from marijuana said they had sex an average of 5.6 times in the four weeks before the survey, compared with the daily marijuana users who reported having sex 6.9 times, on average.
          “We were surprised to see the positive association between users,” Eisenberg said. “This was across the board: marital status, race, none of that mattered.” The study focused on heterosexual sex, and it didn’t explain why there might be a connection between sex and marijuana.
          Eisenberg said past research on human and rodent models has shown that marijuana use may generally increase arousal. However, studies have also shown that too much marijuana use can decrease sperm count, and while men may want to have sex more, orgasm may be a challenge.
          “It can have a different impact on different people,” said Joseph Palamar, an associate professor in the Department of Population Health at New York University, who is not connected with the current study.
          He thought it was a “cool epidemiological paper” that “did the best it could with the data,” but it did have limitations. “It’s unclear from the data if people had marijuana in their system before or during sex,” Palamar said. Someone could smoke in the morning but not have sex until the evening, when it wouldn’t be in their system any more, for example. He added he’d like to see a study that could show more of a direct effect on frequency.
          Palamar authored a small study comparing the sexual experience of people who are under the influence of alcohol versus marijuana.
          Studying 24 adults, his research found that people under either influence had increased feelings of self-attractiveness, but alcohol seemed to make people more social and bold and helped them make more connections with potential partners, compared with those people using marijuana. It showed that drinkers typically have more regrets about who they slept with and are less choosey, whereas marijuana users tended to be more selective.
          Because marijuana is still illegal in the majority of places, Palamar found that most people have to smoke in private, and that could lead to more opportunities to initiate intimacy, compared with people who drink, since alcohol is everywhere.
          Marijuana may also have increased some people’s sensitivity during the act itself, although some reported getting so “lost in their own heads,” they weren’t paying as much attention to their partners, and they did not enjoy sex as much.
          “And if marijuana makes you paranoid, as it does with some people, it could really, pardon the pun, screw your ability to have an orgasm,” Palamar said. Some women also reported vaginal dryness when they smoked pot, and that too can limit sexual pleasure.

          See the latest news and share your comments with CNN Health on Facebook and Twitter.

          Both scholars hoped these studies will encourage other researchers to dive deeper into the topic. In the meantime, Eisenberg said that if a patient asks whether his frequent marijuana use is getting in the way of his sex life, he will tell them that “it may not be the culprit.”
          Regular marijuana use can have other impacts on your health. Research in adults is still limited, but what we know is that smoking can irritate your lungs, and studies have shown it can raise your heart rate, making you more vulnerable to a heart attack.
          “For most people, we tell them instead to go to the gym and lose 20 pounds,” Eisenberg said. Being overweight can give men arousal problems.
          “We always talk about anything that can be good for your heart can be good for your penis,” he said. “For a lot of guys, hearing that is an amazing motivator.”

          Read more: http://www.cnn.com/2017/10/27/health/marijuana-increased-sex/index.html

          Sixth mass extinction of wildlife also threatens global food supplies

          Plant and animal species that are the foundation of our food supplies are as endangered as wildlife but get almost no attention, a new report reveals

          The sixth mass extinction of global wildlife already under way is seriously threatening the worlds food supplies, according to experts.

          Huge proportions of the plant and animal species that form the foundation of our food supply are just as endangered [as wildlife] and are getting almost no attention, said Ann Tutwiler, director general of Bioversity International, a research group that published a new report on Tuesday.

          If there is one thing we cannot allow to become extinct, it is the species that provide the food that sustains each and every one of the seven billion people on our planet, she said in an article for the Guardian. This agrobiodiversity is a precious resource that we are losing, and yet it can also help solve or mitigate many challenges the world is facing. It has a critical yet overlooked role in helping us improve global nutrition, reduce our impact on the environment and adapt to climate change.

          Three-quarters of the worlds food today comes from just 12 crops and five animal species and this leaves supplies very vulnerable to disease and pests that can sweep through large areas of monocultures, as happened in the Irish potato famine when a million people starved to death. Reliance on only a few strains also means the worlds fast changing climate will cut yields just as the demand from a growing global population is rising.

          There are tens of thousands of wild or rarely cultivated species that could provide a richly varied range of nutritious foods, resistant to disease and tolerant of the changing environment. But the destruction of wild areas, pollution and overhunting has started a mass extinction of species on Earth. The focus to date has been on wild animals half of which have been lost in the last 40 years but the new report reveals that the same pressures are endangering humanitys food supply, with at least 1,000 cultivated species already endangered.

          Tutwiler said saving the worlds agrobiodiversity is also vital in tackling the number one cause of human death and disability in the world poor diet, which includes both too much and too little food. We are not winning the battle against obesity and undernutrition, she said. Poor diets are in large part because we have very unified diets based on a narrow set of commodities and we are not consuming enough diversity.

          The new report sets out how both governments and companies can protect, enhance and use the huge variety of little-known food crops. It highlights examples including the gac, a fiery red fruit from Vietnam, and the orange-fleshed Asupina banana. Both have extremely high levels of beta-carotene that the body converts to vitamin A and could help the many millions of people suffering deficiency of that vitamin.

          Quinoa has become popular in some rich nations but only a few of the thousands of varieties native to South America are cultivated. The report shows how support has enabled farmers in Peru to grow a tough, nutritious variety that will protect them from future diseases or extreme weather.

          Mainstream crops can also benefit from diversity and earlier in 2017 in Ethiopia researchers found two varieties of durum wheat that produce excellent yields even in dry areas. Fish diversity is also very valuable, with a local Bangladeshi species now shown to be extremely nutritious.

          Read more: https://www.theguardian.com/environment/2017/sep/26/sixth-mass-extinction-of-wildlife-also-threatens-global-food-supplies

          People are living longer, but violent deaths are on the rise

          (CNN)Conflict, terrorism and gun violence are claiming more lives around the world now than a decade ago, according to a new study published Thursday in the health journal The Lancet.

          Deaths caused by war and terrorism spiked after 2006, with 150,500 reported in 2016 — a 143% increase from 10 years earlier. These fatalities occurred largely as a result of conflicts in North Africa and the Middle East, the researchers noted.
          Worldwide, gun deaths also climbed during the same period: In 2016, firearm suicide fatalities reached 67,500 and firearm assault casualties rose to 161,000, increases of 4.3% and 5.7%, respectively, from 2006.
            Guns may be the direct cause of more deaths, but the there was an overall 3% decrease in fatalities caused by self-harm during the decade ending in 2016, the study indicated.
            The Global Burden of Disease study, an annual assessment of health trends, provides worldwide and national estimates on more than 330 diseases, causes of death and injuries in 195 countries and territories. The study, coordinated by the Institute for Health Metrics and Evaluation at the University of Washington in Seattle, requires assistance from more than 2,500 researchers around the globe.
            One of several sunny spots in the report: Worldwide, people are living longer.

            Life expectancy on the rise

            Generally, male life expectancy was lower than female from 1970 through 2016. Currently, the average global life expectancy for women is 75.3 years, while men can expect to see 69.8 years on the planet. Life expectancy for both sexes combined is 72.5 years.
            By contrast, global life expectancy combined was 58.4 years in 1970 and 65.1 in 1990. In 2000, the combined expectancy was 66.8 years, and in 2005, it was 68.4 years.
            Of all the nations, Japan boasts the highest life expectancy at 83.9 years (a combined figure for both sexes), while people living in the Central African Republic can expect only 50.2 years, a global low.
            Several countries have seen recent large increases in life expectancy, far beyond expectations for their levels of development.
            These countries include Ethiopia, where life expectancy in 2016 was 64.7 years for men and 66.5 for women; the Maldives (77.6 years for men and 81.3 years for women); Nepal (69.7 years for men and 71.9 years for women); Niger (60.6 years for men and 62.8 years for women); Portugal (77.8 years for men and 84.0 years for women); and Peru (77.8 years for men and 81.6 years for women).
            These “exemplar” nations may offer insight into which policies are most successful for accelerating health progress, the study authors noted.

            Children reach a milestone

            “In 2016, for the first time in modern history, fewer than 5 million children under age 5 died in one year, as compared to 1990 when 11 million died,” Christopher Murray, a co-author of the report and director of the Institute for Health Metrics and Evaluation, wrote in an email. In 1970, 16.4 million deaths were recorded for this age group.
            Last year, lower respiratory infections, neonatal preterm birth complications and neonatal encephalopathy due to birth asphyxia and trauma were the most common causes of fatality for children under 5. Combined, these three causes resulted in 1.80 million deaths in 2016.
            Overall, there was what researchers described as a “profound” shift toward deaths at older ages: a 178% increase in deaths among people 90 to 94 and a 210% increase among those older than 95.
            In 2016, there were 1.7 million stillbirths worldwide. The rates decreased substantially between 1970 and 2016, from 41.5 stillbirths per 1,000 live births to just 13.1 per 1,000.
            This decrease occurred against a backdrop of increasing live births around the globe; in 2016, 128.8 million livebabies were born, compared with 114.1 million in 1970.
            Finland had the lowest rate of stillbirths at 1.1 per 1,000 live births, while South Sudan had the highest rate, at 43.4 per 1,000. Central sub-Saharan Africa’s stillbirths, which exceeded 23 per 1,000 live births in 2016, rank as the highest regional rates on the globe.

            Taking aim at early death

            A key measure of health is mortality — particularly at younger ages — and so avoiding early death from any cause is a key goal of health systems worldwide, noted the researchers.
            Early death is most often caused by diseases of various stripes.
            In 2016, noncommunicable diseases contributed 72.3% to the total number of deaths around the globe — 54.7 million — with 19.3% of deaths caused by communicable, maternal, neonatal and nutritional diseases. Injuries, including those incurred by violence, accounted for 8.4% of all deaths.
            “Population growth does not inherently mean there will be more deaths — it depends on a number of factors,” Mohsen Naghavi, a study co-author and a professor of global health at the Institute for Health Metrics and Evaluation, wrote in an email.
            “We provide total counts of death, death rates by age, and age-standardized rates of death to tease out what component of change in deaths comes from a population increasing in size over time, the ageing of populations, and true change at each age,” Naghavi wrote.
            Ischemic heart disease — a condition that restricts blood flow throughout the body — caused 9.48 million deaths in 2016, an increase of 19% since 2006. It ranked as the leading cause of early mortality in all regions of the globe, apart from low-income countries.
            In the poorest nations, the leading cause of early death was lower respiratory infections, including pneumonia and other bronchial conditions. Combined, these resulted in 2.38 million deaths, a decrease of 8.2% since 2006. Diabetes caused 1.43 million deaths globally last year, an increase of 31.1% since 2006.
            Deaths from infectious diseases have decreased since 2006, but HIV/AIDS claimed 1.03 million lives in 2016 (a 45.8% decrease since 2006), while 719,500 people died from malaria (a 25.9% decrease) and 1.21 million died from tuberculosis (a 20.9% decrease) last year.
            Dengue, a mosquito-borne infection that can lead to a fatal hemorrhagic fever, increased sharply over the decade — by 81.8% — and caused 37,800 deaths in 2016. Extensively drug-resistant tuberculosis, which caused 10,900 deaths in 2016, also showed increasing rates throughout the past decade, rising by 67.6% since 2006.

            ‘Triad of troubles’

            Nearly one in every five deaths is linked to a poor diet, the report revealed. Diets lacking in whole grains, fruit, nuts and seeds and fish oils while providing too much salt were the most common dietary risk factors, the authors noted.
            As a result, high blood glucose, high blood pressure, high body mass index and high total cholesterol were among the top 10 leading risk factors for death for men and women globally.
            Nations and people are likely to tackle — or at least attempt to tackle — those diseases that kill at high rates, Murray noted, since death is a powerful motivator. “But, we’ve been much less motivated to address issues leading to illnesses,” he said
            Tobacco, which caused 7.1 million deaths across the globe in 2016, is another issue leading to illness.
            Another factor that sometimes lacks attention from policy-makers is mental illness, which in many cases contributes to disability.
            “Mental illnesses tend not to discriminate based on income,” Theo Vos, a study co-author and professor of global health at the Institute for Health Metrics and Evaluation, wrote in an email.
            “In 2016, 1.1 billion people were living with mental health and substance use disorders,” he noted. “Major depressive disorders ranked in the top 10 causes of years lived with disability in all but four countries worldwide.”
            Those four nations are American Samoa, Philippines, Myanmar and Indonesia.
            “There is considerable overlap between mental health disorders and substance use disorders,” Vos wrote. “People suffering from both types of disorders present considerable extra challenges to health services as one problem can interfere with the successful treatment of the other.”

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            Overall, the National Institutes of Health-funded study reveals a portrait of a globe precariously balanced between health successes and health failures — with some of the latter being intractable yet avoidable.
            “A ‘triad of troubles’ — obesity, conflict, and mental illness, including substance use disorders — poses a stubborn and persistent barrier to active and vigorous lifestyles,” Murray wrote.

            Read more: http://www.cnn.com/2017/09/14/health/global-gun-deaths-rise-study/index.html

            The FDA has approved a blood sugar monitor that doesnt require a finger prick

            Further proof the U.S. Food and Drug Administration has been warming up to modern technology — it has just approved the first continuous blood sugar monitor that doesn’t require the user to prick themselves over and over for a blood sample.

            Today, the FDA cleared Abbot’s FreeStyle Libre Flash Glucose Monitoring System, a device that uses a small sensor wire inserted under the skin to determine glucose levels in adult diabetics. Another wand-like device is then waved over the sensor to measure and give a readout of those glucose levels.

            This is a milestone move for the FDA as diabetes affects nearly 30 million people in the United States who currently have to test their blood sugar by pricking themselves several times throughout the day and every time they eat.

            However, the idea for a prickless blood sugar monitor isn’t new. Tech companies have increasingly shown an interest in the massive diabetics market over the past few years. Apple is rumored to be working on such a device and its CEO Tim Cook has even been spotted wearing a possible prototype that could connect to the Apple Watch.

            Other companies endeavor to build something similar, including Glucowise, which has a device still under development.

            However, it seems it’s not so easy to create a needleless blood sugar detector. Google tried to build a contact lens that could detect glucose but it seems the project has gone nowhere since drug company Novartis licensed the tech in 2014. Another FDA-approved device for glucose monitoring without the prick called the GlucoWatch was approved in the early 2000’s, but consumers found it cumbersome and it happened to cause a bad rash in some.

            But there’s new hope today that the Freestyle monitor has worked out all the kinks. The device is intended for those 18 and older and, after a 12-hour start-up period, can be worn for up to 10 days, according to a statement on the FDA’s website.

            “The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said FDA spokesperson Donald St. Pierre. “This system allows people with diabetics to avoid the additional step of finger stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”

            Read more: https://techcrunch.com/2017/09/28/the-fda-has-approved-the-first-blood-sugar-monitor-that-doesnt-require-a-finger-prick/

            Revealed: Johnson & Johnson’s ‘irresponsible’ actions over vaginal mesh implant

            Woman awarded record $57m damages over implant launched with no clinical trial and marketed despite higher failure rate

            A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.

            Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that could compromise the future of the device.

            J&Js Ethicon unit was found by a US court to be liable for the serious injuries Ella Ebaugh suffered after receiving a mesh implant to treat urinary incontinence. The mother of five said she was left with a mangled urethra, bladder spasms and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder.

            But documents submitted to the court show J&J staff had raised concerns about the spinning of data in emails and male executives are seen bantering about a suggestion that sex with an earlier patient with mesh complications must be like screwing a wire brush.

            Ella
            Ella Ebaugh, who was awarded $57m after a court ruled that Johnson & Johnsons Ethicon unit were liable for the serious injuries she suffered. Photograph: CBS

            When it emerged from initial data that the success rates for a new device looked to be way below those seen for previous products, Ethicons director of sales, Xavier Buchon, suggested in an email stop[ping] for a while such publications that could compromise the future.

            The J&J implant, used to treat urinary incontinence, was launched in 2006. Despite the early indications of a high failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia. The documents raise uncomfortable questions for the manufacturers of vaginal mesh products, which are the subject of growing controversy.

            The implants, which reinforce tissue around the urethra, are widely used to treat incontinence, and for the majority of women the procedure is quick and successful. However, some women have suffered debilitating complications, including severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.

            Class action law suits are underway in Australia and the US, where lawyers claim that patients have been exposed to unacceptable risks; in England, NHS data suggests as many as one in fifteen women later requires full or partial removal of the implant.

            Vaginal mesh implant

            Ebaugh, whose case was heard in Philadelphia, said that her complications have left her with constant pelvic pain, meaning for example, that although she attended her daughters recent wedding, she was unable to enjoy it. I feel like Im on fire down there, she said in an interview with CBS.

            The tranche of documents, revealed during the trial, places a spotlight on tensions between Ethicons commercial and clinical divisions at the time it launched its miniature mesh product, called the TVT-Secur, in 2006.

            The company hoped that the new device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market ahead competitors, who had similar offerings in the pipeline, was described as priceless in company documents. It was approved for use without a trial under US and European equivalence rules, which allow this when a new device is similar to existing ones.

            Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, condemned the decision to launch a device before a trial, saying this had led to direct patient harms. It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients, he added.

            Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, told the Guardian the company had acted irresponsibly by launching the device without adaquate evidence.

            Ahead of the devices original launch, Jacquetin was invited to the US to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicons original TVT mesh device.

            On learning that Jacquetins results did not look promising (though not referring to the eventual 77% figure), marketing manager, Fabrice Degeneve emailed his superiors to ask: How should we handle this without compromising the use of this new technique?

            Ethicons director of sales, Xavier Buchon, replied: This is for sure a big concern, before suggesting withholding results while the company reviewed the patients to be included in the analysis. No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion, he added.

            In the event, the findings were presented at a major international conference and Jacquetin said he never felt pressure to bury unfavourable results. But he adds: I was really disappointed. I told many people at Ethicon it was not [a good device].

            In 2012, TVT-Secur was withdrawn from the market, along with three other mesh products. J&J declined to provide exact figures on how many women had received the implants.

            In other emails, J&J staff complain of colleagues constantly spinning data and of a dangerous blurring of the lines between commercial and research divisions. I am continually amazed and surprised at our need to push back, wrote Judi Gauld, Ethicons former clinical director in Scotland.

            Other emails show a blas attitude to distressing complications. In one, dated from 2003, a surgeon sought advice on treating a patient with a 2cm stretch of mesh poking through her vaginal wall. Sex is like screwing a wire brush according to her spouse, the doctor wrote. Martin Weisberg, Ethicons medical director, replied: Ive never tried the wire brush thing so I wont comment.

            Following the trial, Ebaughs lawyer, Kila Baldwin, said in a statement: I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly.

            Johnson & Johnson said they plan to appeal the verdict. In a statement, the company said: We believe the evidence in the Ebaugh trial showed Ethicons TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiffs continuing medical problems.

            Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.

            Read more: https://www.theguardian.com/society/2017/sep/29/revealed-johnson-johnsons-irresponsible-actions-over-vaginal-mesh-implant