A skeptical look at popular diets: The lowdown on low carb

In the seventh post in the series A Skeptical Look at Popular Diets, physician Randall Stafford examines down the pros and cons of a low-carb diet.

By Randall Stafford

As the name implies, this diet reduces dietary carbohydrates, including many common foods that contain sugars and/or starches. To make up for this reduction, the intake of protein and fat can increase. Frequently, however, low-carb dieters do not fully replace the calories from reducing carbs and they lose weight as a result.

This diet has several favorable features, but a high intake of animal-based saturated fats can offset the benefits. One version, the Atkins Diet, was promoted to facilitate weight loss. A problem with interpreting “low carbohydrate” is that there is no consensus on how low is “low.”

Health rationale slogan: Restricting carbs helps you lose weight and solves many metabolic problems.

Analysis: Depending on how low carb you go, a lower carb diet potentially restricts multiple common foods including grains, legumes, fruits, breads, desserts, pastas, and starchy vegetables. Particularly off-limits: processed foods made with flour and added sugars. Food sources higher in protein and fat take their place, such as meats, eggs and nuts.

The diet’s potential benefits are many, including helping reverse insulin resistance, an early stage in the development of type 2 diabetes. It does this by restoring normal carbohydrate processing. By restricting carb intake, the body no longer has to cope with a large, sudden influx of sugar into the bloodstream. In addition, people following this diet may experience less hunger when they restrict calories, which facilitates weight loss (at least in the short term).

Stanford nutrition scientist Christopher Gardner, PhD, studied longer term weight loss and demonstrated similar favorable benefits from a lower carb vs. a lower fat diet when both approaches focused on healthy choices.

The food sources that are low carb range widely in healthfulness. For example, meat has no carbohydrates, but if meat intake is increased to replace carbohydrates, this can boost unfavorable saturated fats. Interestingly, in Gardner’s weight loss study, the group that followed a healthy low-carb diet had no adverse metabolic effects. This group decreased overall calories almost solely by restricting carbohydrate-rich foods, without substantially increasing protein or saturated fat intake.

If the carbohydrate restriction goes beyond added sugars and refined grains, to the point of restricting vegetables, whole grains and beans/legumes, this can result in vitamin and mineral deficiencies. And, if carb intake is low enough, ketosis can occur with its accompanying nausea, headache, physical and mental effects, and bad breath. Additionally, carbohydrate-rich foods are the primary sources of fiber, and low-fiber diets increase the risk of colon cancer and may have adverse effects on the gut microbiome.

Easy to follow?: Depending on how severe the carbohydrate restriction, this diet can be difficult to follow because it can dramatically restrict the intake of most of the major food groups, including fruits, beans/legumes, grains, starchy vegetables, and dairy.

Dominant source of protein: Animal proteins such as meat and eggs, which don’t contain carbs (unlike protein-rich legumes and grains).

Most common fats: Oils and saturated fats from meat.

What about carbs?: Limited carbs, but some variations of this diet can include potentially good carbs found in fibrous vegetables and beans/legumes.

When it goes wrong: Emphasizing meat consumption can lead to problems. High intake of the saturated fats found in meat may increase the risk of future heart disease and cancer. This harm would be greatest from emphasizing fatty red meats (steak, bacon, etc.) or processed meats, as opposed to leaner meats, such as poultry.

To make it healthier: The potential health benefits of lower carb diet can be maximized by focusing primarily on eliminating added sugars and refined grains, and emphasizing sources of fat from plant sources (e.g., olive oil, nuts, avocados), from fatty fish (e.g., salmon), or from lean meats.

Variations: The Atkins diet emphasizes restricting carbs, but allows as much fats and protein as desired. If carbohydrates are severely restricted, a low-carb diet becomes a ketogenic diet.

If you’re going to cheat: Including beans/legumes may make sense because their more complex starches and fiber differ from the simple starches in processed grains and starchy vegetables. Eating these foods provides a much greater range of possible foods, making the diet easier to follow.

Conclusion: A lower carb diet can offer weight loss and metabolic improvements. In its extreme forms where all starchy vegetables, bean/legume, fruit, and grain intake is restricted, it is difficult to follow and has the drawback of high saturated fat and low fiber intake.

Nonetheless, this diet could be a good starting place for initiating weight loss when the focus is on minimizing added sugars and refined grains, and maintaining or even increasing fibrous vegetables.

This is the seventh post in a series called A Skeptical Look at Popular Diets. The series will review the eight currently most prominent diets in America. The next blog post will discuss low-fat diets.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford. He practices primary care internal medicine and studies strategies for preventing chronic disease. Stanford professor and nutrition scientist Christopher Gardner, PhD, examines the impact of diet on health and disease. Min Joo Kim provided research assistance.

Photo by Jakub Kapusnak

Rory Media Kit

What’s Rory?

Rory is an end-to-end service for women’s health offering accessible, high-quality, personalized healthcare to help women through the biological changes of midlife and beyond.


  • Announcement date — Wednesday, March 20th, 2019
  • Pricing — Products start at $9 per month
  • Availability — Rory products will be available nationwide. Telehealth services will launch in 47 states, covering over 99% of the U.S. population
  • Website — www.hellorory.com

Why focus on midlife.

There are two large hormonal shifts in a woman’s life: puberty and menopause; the permanent absence of menstrual cycles (NCBI). While puberty is a largely guided process (moms having “the woman talk” with their daughters) menopause is often a lonely and confusing shift, one that approximately 43M women in the U.S. between the ages of 45 and 64 experience (CDC). Many women are unprepared to deal with the changes they go through during midlife and nearly 55% of women going through menopause don’t do anything at all to treat symptoms (ACOG).

Almost all women will experience at least one symptom of menopause, if not many. These can include low libido, mood changes, weight gain, chills, hair loss, dry skin, insomnia, vaginal dryness and hot flashes.

Hot flashes, for example, are estimated to occur in over 75% of women (ACOG). They typically last 5–7 years but can last up to 10–15 years (HHP). While simply annoying for some, hot flashes can be debilitating for others.

Unlike hot flashes and other general menopausal symptoms, vaginal changes do not improve with time. While symptoms such as lack of lubrication and pain with sex affect up to 45% of women in midlife and older, only a minority seek help or are offered help by their health provider (NAMS). When women were asked how vaginal discomfort affected their lives, 80% said it affected their lives negatively, 75% said it had negative consequences on their sex life, and 68% said it made them feel less sexual (VIVA).

Even healthcare providers grapple with conditions in midlife. When asked specific questions about vaginal dryness, a quarter of gynecologists, and one third of general health practitioners were not able to correctly answer the questions (NAMS).

The unmet need here is huge.

Rory’s homepage

Why is Rory a game changer?

Rory is the first nationwide telehealth service for women in midlife. Developed by experts in women’s health, Rory provides women with a much needed menopause treatment plan to restore their quality of life and serve as a confidante. Rory offers white-glove care, education and resources to better understand and deal with menopausal symptoms anytime they come up.

Rory offers both holistic and prescription solutions backed by science for common menopause symptoms. Rory meets women where they’re comfortable — equipping them with options to make more informed decisions about their treatment options.

How Rory Works

1. Doctor’s Visit — Complete an online doctor’s visit about your medical history, lifestyle and menopause symptoms. A Rory-affiliated physician will review your information, follow up with any questions via message, phone or video, and determine if prescription treatment is appropriate for you.

2. Treatment — Should the physician deem it safe and appropriate for a prescription via telehealth, they will recommend a personalized treatment plan. The treatment will be shipped (for free) from Ro’s own pharmacy network.

3. Support — Rory members receive ongoing support from their Rory-affiliated physician, and can message them at anytime. They can also join Rory’s online community, Roar, to get support from other women experiencing menopausal symptoms.

Rory is not a replacement for in-person doctor visits, it’s a complement to help women safely and easily seek help for bothersome menopausal symptoms outside of their interactions with their primary care physician.

Farewell, Dr. Gottlieb, you will be missed

What his resignation means for the industry

This past Tuesday, March 5th, the life science and healthcare worlds were gripped by near-universal shock and sadness when Dr. Scott Gottlieb announced his resignation as the commissioner of the Food and Drug Administration (FDA), effective next month.

Gottlieb entered office with nearly the perfect resume for being FDA Commissioner — a medical doctor, former FDA Associate Commissioner during the GW Bush administration, a regulatory policy wonk, and a biotech VC — he had an ideal set of lived experiences for navigating a very difficult job that requires balancing the interests of different stakeholders with often diametrically opposed views. And, he performed that job splendidly, earning praise from industry, Congress, President Trump, and the press. Unlike many of his predecessors, it is difficult to find people who are critical of his tenure.

And contrary to the belief of those who are critical, industry’s support of Dr. Gottlieb was emphatically not because he was an “anything goes, let’s neuter FDA” shill for Big Pharma. Indeed President Trump was considering, before choosing Dr. Gottlieb, candidates of exactly that mindset, which frightened the industry. Scott Gottlieb was loved, especially those of us who work primarily with startups, because he moved incrementally in a pro-innovation direction, while being transparent about his objectives. No one benefits from a (presumably Republican) FDA Commissioner who plays it fast and loose. In life science you must think in decade-long terms, and with that mindset you inevitably realize that the next FDA Commissioner can reverse any policy that their predecessor may have implemented by fiat.

What industry needs from a regulatory agency is predictability and responsiveness to new trends in innovation. Gottlieb delivered both. He was attentive to, effectively, every new trend in medical technology: digital health, synthetic biology, generics, biosimilars, the widening epidemic of teen e-cigarette use (vaporizers with e-liquids containing nicotine and flavors), and addressing opioid misuse. In nearly every arena one got the sense that FDA was actively monitoring and thinking about how to further its mission of protecting public health while helping to speed innovations that make medical products more effective, safer, and more affordable.

So what does his resignation mean?

Immediately, not much. The FDA Commissioner has little to do with day-to-day facility inspections and product approvals that characterize much of the Agency’s work. Center directors Dr. Janet Woodcock (of CDER) and Dr. Jeffrey Shuren (of CDRH) remain in place, and they will continue implementing policy directives developed over the past two years. But the Commissioner acts in a sense like the captain of a supertanker, setting direction and cadence, and defending those decisions to outside stakeholders (notably Congress). Dr. Gottlieb has done this well and established a significant legacy in a short period of time; his tireless efforts to drive innovative policies at FDA is matched by his dedication to family and his decision to return full-time to their home in Connecticut. Whomever is next appointed to succeed him has big shoes to fill.

Though we at Enzyme have great respect for Dr. Gottlieb and his handling of a difficult position, and more broadly his public service, we also think this is a time to reflect: Why does the choice of an FDA Commissioner matter so much? Ultimately, it’s because the process of regulatory approval for drugs and medical devices is still too opaque and arbitrary, forcing stakeholders to ‘read the tea leaves’ about how their regulator might react to new, particularly novel, products or initiatives. A leader at FDA perceived as being pro-innovation bolsters confidence (and investment). But this is a dynamic that is not particularly healthy.

That’s why at Enzyme, we spend each day building products that add clarity and certainty to the regulatory process. Our mission is to advance human health by reducing the time and cost of the medical product lifecycle. If you’re building medical technology, or you’re interested in helping all those who are get their products to market faster, and therefore benefit all of us, please get in touch.

We offer Dr. Gottlieb our thanks and best wishes and wish him happy trails for whatever comes next.

Green Exercise — Fitness Friday — Sabrena Jo

The Not Old Better Show, Fitness Friday Series, with Sabrena Jo

The Not Old Better Show, 2019. Image: AdobeStock

Welcome to The Not Old Better Show, I’m host Paul Vogelzang, and this is episode 326. Today’s show is brought to you by Earlybird CBD.

“Green Exercise” helps promote mind body wellness

Our show today is part of our Fitness Friday series, and it’s another great one in our Fitness Friday programs. We’ll be hearing from returning guest, Sabrena Jo.

Sabrena Jo, American Council on Exercise, Director of Science & Research Content

Sabrena Jo, left, of course, is a favorite with our Not Old Betteraudience and is the American Council on Exercise, Director of Science and Research Content. Sabrena Jo, is speaking to us today about some very exciting research which suggests that exercising in a “green environment”may provide even more health benefits than when exercising indoors, but as always, there are some important areas to consider. In fact, green exercise has been shown to reduce stress, lower blood pressure, improve mood, increase self-esteem, and enhance perceived health.

Please visit our sponsor Earlybird CBD, and support the show. Enter NOTOLDBETTER at checkout for 20% discount. https://earlybirdcbd.com/NOTOLDBETTER

For more information, please check out: https://notold-better.com

The Not Old Better Show, 2019.

Importance Of Eggs In Your Diet

Remember the scene in Rocky, where he gets out of the bed, breaks 12 eggs in a mug and drinks them raw…. Yaaaa ….

Apart from speed and agility, reflexes and endurance the most important part of a players ability which can make the real difference is strength. The first thing that comes to mind when I think of tennis and strength together is of Nadal, crushing the ball with his big powerful arms and legs.

Diet plays such an important role in a player’s progress and performance. What goes in reflects outside right? So, are you looking to hit the ball with increased spin and power? Well, then its time to increase your strength and power.

What’s The Eggs Made Of

The best way to increase strength in the most inexpensive way is to eat eggs. According to Authority Nutrition, it is considered the highest nutritional food available. Here is a more scientific and detailed view on what the egg really contains –

Source — Authority Nutrition

A single large boiled egg contains –

  • Vitamin A: 6% of the RDA.
    • Folate: 5% of the RDA.
    • Vitamin B5: 7% of the RDA.
    • Vitamin B12: 9% of the RDA.
    • Vitamin B2: 15% of the RDA.
    • Phosphorus: 9% of the RDA.
    • Selenium: 22% of the RDA.
    • Eggs also contain decent amounts of Vitamin D, Vitamin E, Vitamin K, Vitamin B6, Calcium and Zinc.
    • This is coming with 77 calories, 6 grams of protein and 5 grams of healthy fats.

Well that is huge. Imagine you are feasting upon around 3 to 4 eggs a day after a gruesome training session, and you will see the difference within 1 week or so.

How They Help You In Your Game –

• Eggs are way more fulfilling and keep you lean as you do not consume unnecessary calories. In short, you get fit and not bulky, which is very important for tennis players
• They supplement your muscles and help you stay longer on the court and hit the ball with extra power and energy.
• They further heal up those torn fibres and help you built strong muscles.
• Help in recovery process too

In the end I will conclude with the most renowned slogan of NCC –

“ Sunday ho ya Monday, Roz khao ande”

8 Foolproof New Year’s Resolution

Goodbye, 2017. Hello, 2018! 👋

If you’re reading this: give yourself a pat in the back. You’ve managed through all the goods and the bads that 2017 has thrown at you 👏

Now that the New Year is just right around the corner, it’s time to think about the good things that happened this year and jumpstart your 2018 for success! We usually take the time to reflect what we’ve accomplished so far and make some goals to make ourselves better for the upcoming year.

New Year symbolizes a new beginning, a step towards a better self.

What’s your New Year’s Resolution for this upcoming year?

1. Eat more fruits and vegetables

According to MyPlate, eating an overall healthy diet that is rich in fruits and vegetables may reduce risk of heart disease, certain type of cancers, obesity, and type 2 diabetes. As fruits and vegetables tend to be low in calories, it can lower calorie intake. Furthermore, eating fruits and vegetables that are high in fibers keep you full for longer — perfect to lose some of that holiday weight!

Keep track of your fruits & vegetables servings with EatLove

2. Drink more water

Did you know that two-third of our body consists of water? Thus, it seems like a no-brainer that getting enough water everyday is essential for our bodily function. CDC mentions that water aids in balancing body temperature, lubricates joints, protects spinal cords and other sensitive tissues, and get rid of wastes.

3. Meditate

Set aside a few minutes of your day to de-stress and clear your mind. Studies suggest that meditation improves emotional health, helps to develop stronger understanding of oneself, increases attention-span, fights insomnia and pain, and decreases blood pressure.

4. Get moving 🏃

Be it going up the stairs instead of taking the elevator, parking in the farthest lot when you go grocery shopping, or a full on workout — every little step you take (pun intended) counts. Some of the health benefits of physical activity includes weight management, reduced risk of some cancers, heart diseases, type 2 diabetes, and improvement of mood and mental health, CDC mentioned.

Tip: The Physical Activity Guidelines for adults is 150 minutes per week of moderate-intensity aerobic physical activity (think brisk walking) or 75 minutes of vigorous-intensity aerobic exercise (like jogging or swimming laps) per week.

5. Try out 1 new (healthy) recipe each week

Get out of your dinner rut by challenging yourself to try venturing out from your typical ‘chicken & broccoli’ recipe. By choosing a different variety of food across different food groups, you are more likely to obtain different nutrients and have a well-balanced diet. And who knows if you end up discovering your new favorite recipe?

Which one of these will be your new dinner rotation?

6. Meal plan + prep

A study conducted by USDA found that foods that are prepared outside of home are higher in saturated fat, sodium, and cholesterol and lower in dietary fiber than food prepared at home. Meal planning also helps you to stay within your budget, save time, and decrease food waste.

EatLove — Save time & money, and decrease food waste every week!

7. Get enough sleep

How many hours of sleep are you getting each day? According to National Sleep Foundation, younger adults & adults (age 18–64) should be getting 7–9 hours of sleep daily. And no, you can’t save it all for the weekends!

8. Be kind to yourself

Give yourself some recognition when you hit your new plank record or crush you weekly work goal. But also remember to not beat yourself up too much when you’re feeling stressed out and forgive yourself when something did not go as you planned.

The substance of enjoyment

On how you don’t need a whip to get you dancing.

Photo by Alex Iby on Unsplash

A few years ago, my friend said to me “Abstinence is true hedonism”. He was reading into Daoist philosophy and was taken with the idea of giving something up daily. He had started along the way with grain avoidance. I joked that when he ran out of things to give up he would just have to sleep all day and start again in an alternative dream world full of stuff. I never really gave it any real consideration though until it came to me during a recent hangover. I was thinking the usual self doubting statements during this head achy episode; here I am again in self sabotage, I really ought to not keep doing this to myself. Isn’t it time for some purposed sobriety? Shouldn’t I have more discipline by now and aren’t I getting too old to be feeling like this? Not at all how I would talk to a friend in the same situation. Perhaps the only thing I really needed to give up was having a go at myself.

Needless to say within 24 hours I was fine. It had, after all, been a fantastic night out with loved ones. Other than when I have the severe whiskey blues, I tend to think that the idea of self sabotage is a trend induced myth, and that what we essentially grasp for is akin to the Pleasure Principle. One of the only issues could be that, often times, a lot of us extend our reach beyond our unit intake capability and out of our bank balances. It’s daft at worst. In my case, I basically just want to have a good time, not to intentionally cause myself any pain or discomfort. That’s not to say that alcohol cannot be a destroyer of anyone's’ livelihood, family or friendships. My own father was dependent upon the stuff, violent with it, and totally disconnected without it from what I can remember. Needless to say, its understandable that people, myself included, tar their own alcoholism with the same brush, especially with such close to home association.

A more productive means of me approaching sobriety, I realized, was in fact not to keep perpetuating the narrative of the psychodrama. Instead I decided to step back from the perceptual turmoil of how I, apparently, relentlessly damage myself for some hidden agenda. Or the insistence that I’m having so much fun as a means of covering some distorted view of myself, which is pop self help, verbatim. A better means would be to take on the challenge of potentially finding a kind of pleasure that I haven’t got access to during my periods of routine alcoholism. Realizing that this is no different to my pursuit in drinking copious amounts of booze some weekends is far more appealing than casting myself as Sisyphus, pushing a boulder up a hill as a punishment, only to drop it down again at the top. My friend had a lot of conviction when he said that sobriety was the gateway. We spent a lot of time sitting on his rug drinking loose leaf tea, chatting, laughing and confusing one another during that time. Admittedly I would venture out without him onto stronger substances during the later evenings, but I saw how his sobriety didn’t make him antisocial or uninteresting, even if I was slightly bemused by his approach.

The day after my hangover this time, I recalled how I may well have already tested out his hypothesis. The longest I’ve not drank is 90 days during a fitness and nutrition plan. I don’t recall the euphoria of hedonistic pursuits, but I felt that I had greater stamina and easier ability to lose weight. I enjoyed the compliments I would get from people as I like being told that I look good. I also loved being able to run further and having achieved the consistency of attending weekend morning High Intensity fitness classes. There was pleasure in all of it. Likewise though, there was pleasure in the pizza, cake and beer that came all the weeks after jumping off the wagon back into city night life.

I realize now that there is a cycle, almost a rhythmical one, to my bouts of hop induced hedonism versus my stints of abstinence. My friend talked emphatically about the nature of excess as a power of transformation. I think he saw me as being endlessly on this pathway, alternating phases of dualism on repeat. He was sympathetic and sage like in my memory, although in reality we both had bouts of drunkenness together since. I remember him giving me a curried egg for breakfast after a night of partying, telling me that he felt toxic. He would seek out the means of healing and the polluted state would subside, but ultimately I could see that he preferred his sober times as his hangover would cause him to withdraw.

For me, the theology of abstinence as pure hedonism doesn’t completely ring true. Tonight, I will finish my Rioja wine bottle, and tomorrow I will hit the gym. I will have cheat days with pizza and fries, and also eat the greens of the garden daily. I will listen to music that will annoy my neighbors, then jam with them in the kitchen. For me, true hedonism isn’t about making or breaking internal checkpoints on substance control really. Its more a case of weighing up why you enjoy everything that you go for, and also what the repercussions of doing anything might be on everything else. You just have to make sure you can do all the things that you enjoy. If any one particular thing clouds that possibility, then I advise doing a lot less of it. And if it really has got to the point where it stops your enjoyment completely, then it is indeed time to kick it to the curb. Until then, I hope that variation can be a real pleasure.

2018 Philanthropic Efforts

In 2018, our goal at iSalus Healthcare is to expand our philanthropic efforts around the state of Indiana and beyond. We will continue our partnership with Riley Children’s Foundation to raise funds for children and families in need in Indiana. We will also be working closely with Timmy Global Health, an organization founded to expand access to healthcare and empower students and volunteers to solve today’s global health problems.

Founded in Indianapolis, Indiana in 1924, Riley Hospital for Children became Indiana’s first ever children’s hospital. Riley Hospital for Children is one of the largest children’s hospitals in the country and is well-known across the state of Indiana. Riley Hospital partners with the IU School of Medicine, training two-thirds of Indiana’s pediatricians and ranked among the top pediatric research hospitals in the nation.

The iSalus Healthcare mission and values align with those at Riley Children’s Foundation. Here at iSalus, we provide solutions to physicians in order to make sure they spend all necessary time with their patients. We are focused on the well-being of our clients and continue to learn and grow as a company each day. Riley Children’s Foundation values to be mission-focused and results-oriented all while continuously growing and learning as a foundation. We are excited to see what our relationship with Riley Children’s Foundation brings us and we hope to see positive change and growth within the healthcare industry in the state of Indiana.

As well as Riley Children’s Foundation, we want to expand our philanthropic efforts by working with Timmy Global Health. One of iSalus Healthcare’s co-founders, Chuck Dietzen, also founded Timmy Global Health in 1997 in an effort to serve more communities and engage more healthcare leaders. Timmy Global Health’s mission is to expand access to healthcare and empower students and volunteers to tackle today’s most pressing global health challenges. Through their efforts, Timmy Global Health strives to empower volunteers to lead the fight for global health equity and help deliver the promise of a healthy future.

We believe working with Riley Children’s foundation and Timmy Global Health will allow us to be part of improving healthcare and support in Indiana and the rest of the country. If you would like to learn more about how you can partner with iSalus to support these great organizations, please contact renaerossow@isalushealthcare.com.

Interview with David Lester

David Lester

Wikihospitals — Today I’m introducing David Lester from NIESM, an Australian entrepreneur. David, welcome to Wikihospitals.

David, perhaps you can give a brief overview of the product that you’re developing and how it can help people.

David — We’re focusing on providing solutions to help patients with epilepsy achieve better outcomes.

At present, the methodology and the clinical practise is very poor. About one-third of patients actually found to be resistant to therapy, which means they don’t have good outcomes. A big part of that, if you talk to clinicians around the world… is that they rely on the patients to keep accurate records on their seizures.

The reality is, patients don’t do that for a variety of reasons. Consequently, it’s very, very, challenging for the clinician to develop patient management programmes that are personalised and will provide these better outcomes.

We’re using wearable sensors that have been found to be correlated with patient seizures. These are sensors that capture activities such as motion, heart rate, galvanic skin response, transdermal activity, sleep, and a variety of other physiological measures.

What we’re doing is we’re integrating these various solutions, these sensor activities, to come up with personalised methodology for capturing those patient seizures over time. That’s a critical point.

…whereas now days to monitor up a patient for up to five days using EEG, you have to… hospitalised (them).


Wikihospitals — In today’s world, if people are to be diagnosed with epilepsy they have to be admitted to hospital… for a week. (Diagnosis is) a slow process. Even just booking in for an epilepsy unit could take six months.

David — Yes, there’s a variety of different epileptic seizure types… five or six of them are the dominant ones. Some of them are very, very, difficult to capture.

The other complexity is that every patient will have at least two or three of these different seizure types. Every patient has a different seizure profile.

Wikihospitals — …what percentage of people in the population have epilepsy?

David — It’s pretty much globally uniform at about 1%. Interestingly, a very recent report in the US said it’s gone up to 1.3%. It’s climbing and, because people are living longer now… you actually see higher incidence of epilepsy in people with Alzheimer’s.

Wikihospitals — The reality for them is, if they don’t have a proper diagnosis, if they’re waiting too long, or if the diagnosis is incorrect, then they get incorrect treatment.

David — Absolutely. It’s even more complicated than that, because not all seizures are epileptic. About 25% of those patients that have been diagnosed with seizures are non-epileptic. To your point, Delia, you get a very, very, different intervention treatment for those patients than you would the others. Consequently, you’re getting the wrong patient treatment.

Wikihospitals — It sounds as though your product is tending towards the new world of using smart wearable devices, sucking in big data, and then giving a much more accurate (diagnosis). Is that the case?

David — Absolutely. The smart technologies and the digital health are the way of the future, whether you’re talking about the location where everyone is closely linked, or whether they’re remotely associated.

“It’s about understanding what the clinician wants and how clinical practises actually works.”

David — I just came back from a visit to India. If you don’t talk remote monitoring in any management of disease, they’re not going to bother with you. The reality is that translates to better care and lower costs. It’s … a significant improvement all over.

The challenge is, in the western world when you bring in a new technology there’s a lot of resistance generally to it. The clinician doesn’t want to change their standard of practise or standard of care.

What we’re doing is working very, very, closely with leading clinicians around the world to ensure that we’re giving them services … that will not disrupt what they’re doing. On the contrary, what it’ll do is allow them to analyse a lot more patients than they’re doing now far more effectively, which is what they want. The difference in what we do between us and the normal technology company is we’re clinician-driven, not technology-driven.

From Pixabay

Wikihospitals — What sort of device does the patient actually have to wear? Can you give an idea of what this involves for the patient?

David — We like to call it compliant independent. In other words, we rely on the patient as little as possible… it’s a matter of wearing the device and every three to five days you take the device off and then recharge it. At that time of recharge, the information is then being transferred into the network up to our cloud base system. We manage the rest.

What we are doing is very, very simple, putting on the device, and then every three to five days taking it off and recharge it in a docking station similar to what you see with Fitbit or Apple watch. Then once it’s charged, which doesn’t take long, put it back on again and away you go.

Wikihospitals — What size of a device are we talking? Is it large and bulky or is it small?

David — (It’s a) little bit more cumbersome than like Fitbit or Apple watch. At this stage we opted to use devices that have been proven to be clinically competent and performed at a level that’s required for clinical use.

It’s got an elastic arm band, and a couple of electrodes you got to attach. It doesn’t look that great. But, we expect as we evolve this technology that we will develop devices where the patient feels comfortable just walking around every day and not feel that they are stigmatised, because they are wearing some sort of clinical device.

Wikihospitals — For the viewers, that’s in contrast to waiting up to six months to get into an epilepsy ward and then have an EEG cap with tabs all over your head and then staying there for the weekend or longer and being hooked up to monitor continuously, not being able to leave the unit.

EEG cap

“People are non-compliant with medication, I believe up to 50%…”

Wikihospitals — You can damage your brain if you continuously have seizures. Not having an accurately diagnosed epilepsy could have enormous consequences for people.

David — Absolutely. There’s a chunk of people that actually can’t work because of this… there’s a lot of people have seizures multiple times a week, (they) can’t get them under control (and) consequently have no life… It’s really a devastating disease under certain circumstances.

The other thing that I’d add to that is that because patient diaries are also used in clinical trials, a lot of the big pharma companies that were in epilepsy have moved out. Because they’ve found that the reliability of the data they capture using patient diaries were not acceptable and would not give them the value that would allow them to get new drugs on the market. We also are hoping — we are engaged with pharma that we will see an increase of activity in pharma to bringing better drugs out on the market.

From Pixabay

Wikihospitals — How many neurologist who specialise in epilepsy work in the UK?

David — In the UK there are about 600,000 people with epilepsy and there are an estimated 50 or so Epileptologists. Just coming back from India, it’s even worse, not surprisingly. There’s about up to 14 million, 15 million people with epilepsy and I was told by one of the leading practitioners there, there’s about 500 Neurologists in the whole country that can treat epilepsy.

Wikihospitals — That’s terrible.

David — Look, I think these numbers are pretty much uniform. There’s a dramatic shortage of experts in treating epilepsy. I should point out that there’s Neurologists that’s good, Epileptologist are the best, GP is the worst. A big problem with that is the accessibility the epilepsy expert or even knowing that you’d require an epilepsy expert.

“The outcomes very much depended on the present practise — depend on the experience of that doctor that you get.”

Wikihospitals — Tell me about the clinical trials that you’re about to commence.

David — We’ve decided to initially launch our products in the UK. The reason for that is the NHS is very, very progressive in terms of introducing digital health technologies. The first study that we’re doing is with — in Scotland, with the Scottish NHS.

Additionally, we’ve got a site in Portugal and we’re working with the leading Epileptologist there to develop an application there.

It’s been tough for me here, because I’ve had some local Australian parents contact me saying the children are suffering with epilepsy, can I help them? The challenges that people have to understand it’s a long task to bring products to the level where they will be accepted in the clinical healthcare market.

The complexity of developing a medical device really influenced the length of time it takes to get to market.

Wikihospitals — So if moms and dads here see this video, (and) they want to access their product, you telling me you got to wait at least a year and a half?

David — Look, we are working and doing some work — some initial studies with the Royal Melbourne Hospital locally.

There will be a stage, I think, because we are seeing such demand, we will be able to release it to the general public. I can’t put time lines on that.

“The fascinating thing about the Indian healthcare system, is that many of the leading health care providers have remote hospitals. This is the way it’s managed.”

Wikihospitals — You’ve spoken a bit about your son. Would you like to re-visit his issues and how he’s reacted to them?

David — Yes, he was at the age (of) seventeen, diagnosed with juvenile myoclonic epilepsy… it’s interesting talking to him. He noticed that a couple of times he started stuttering and stumbling for words and getting lost. I actually noticed at that time, not knowing as much as I do now about epilepsy, that he would start and suddenly just become immobile for about 60 to 90 seconds. We took him to a Neurologist, who’s local, living in the states at that time… and he… diagnosed him as having juvenile myoclonic epilepsy, and put him on a medication.

I was working at Pfizer headquarters in New York at that time (and) I said, well, let’s get a second opinion. I asked my colleagues and they referred me to the top epilepsy specialist for juveniles in New York, probably in the East Coast. He went through (the history) and said the diagnosis was correct but the drug was wrong. He… would not provide that drug to (young people) because they have all sorts of side effects that are really horrendous. He put him on a different drug.

It took my son having a grand mal, to realise you’ve got to take the drugs every day, which is very important. When I talked to him (my son) said it took about five years until he felt good… and we don’t quite know what feel good means because it’s not just the seizures… there’s other activities because you’re dealing with the brain, obviously, that we just can’t really quite get a handle on. That makes it a challenge.

But, to be honest Delia, our platform… is agnostic… to… technology…

We are capable of integrating imaging very high powered imaging data, genomics data, any form of data that we want we can integrate into it. Why I mention that is because when you start putting all this data together you start to get a better picture of what that person’s phenotype in terms of the disease actually is.

We are very, very optimistic… You will start to see this more generalised overview of a patient. It’s almost like a portal.

Wikihospitals — That’s a huge difference of what we currently have, which is really hit and miss… patients come in… for appointments, maybe every two months. Like you said they present a diary, not very scientific, and they… might or might not (get) the correct treatment.

David — That’s right. And, they’ve got to keep coming back for appointments. That is what happened with my son, it was every six months. It took a long time till he basically became seizure free.

Another challenge, I noticed, that caused the patient — the patient’s not getting good outcomes in a timely manner. If you don’t trust the doctor, you are not going to get good care. That relationship is also another added impact we can have (with our) technology.

Wikihospitals — So, better outcomes for the patient means more compliance with their treatments.

David — Absolutely. It’s generally found that the young, the teenagers — are least compliant. Because they don’t want to be labelled as having some disease.

Image from Pixabay

Wikihospitals — Can you talk about the data that this is… going to pick up.

David — Yes, the basic unit that we’ve got… is a very high powered Fitbit, if you want to talk about simply. It catches motion three different ways; it catches it through accelerometry, it catches through magnetometery and it catches it through GPS. What you end up is with an XY and Z axis for each one of those different types of activity captured. That means you’ve got nine axis of motion. It’s a lot of information.

Then there’s the ability to capture heart rate through pulse oximetry. You can get heart rate variability which a lot of people talked about as a very good measure for certain seizures.

There is, as you mentioned, skin temperature…, (there are) heart rate are sensors that you plug in…. You can also plug electrocardiogram leads… if you want to get very accurate cardiovascular measurements… (also) electromyogram, which is muscular activity.

You can (also) do a whole variety of different monitoring of activities including sleep. What we see is a combination of two or three of these activities that will be specific to that type of epilepsy that you’re looking at. That distinguishes us from anyone else.

“Healthcare should be a lot better than it is. It’s just a giant behemoth. (There is) so much money behind it. It’s very resistant to change.”

Wikihospitals — Can you give us a little bit about your background. You’ve been a serial entrepreneur.

David — I didn’t start as a serial entrepreneur. I started in the basic research.

I started in Australia went to Israel, went to the States. After about 15 years, I came to the conclusion that there are better researchers than I am, even though I was successful at it. So, I said let’s try something else.

I was in the US at the time and I got accepted into the US Food and Drug Administration doing what’s called regulatory research, and I spent time there and moved up the ranks. I was trying at that time also to bring new methodologies into clinical trials to help move them along. I realised it was very hard to be innovative in the FDA at that time. I then moved into the pharmaceutical world. I was responsible for introducing new technologies into clinical trials. I moved to Pfizer headquarters in New York… we (were) looking at clinical practice (and realized that) if we add healthcare technologies such as diagnostics to a drug, we (might) end up with better outcomes.

I left them and… joined a couple of companies, one of them was very, very controversial. I learned a lot… on how not to run a company. Then I started up on my own. Had a few attempts. There’s one that’s still ongoing, a Boston based company, called Inside Tracker, which is focusing on health and wellness.

I came back to Australia for personal reasons. I tried working with the CSIRO, and realised that I’m not suitable for large organisations. After advising and mentoring some people said, get back to what you do (best). Hence, about two and a half years ago I started NIESM.

It’s been a long journey. I think the cause of all experiences I’ve had, good and bad, this is going to be the best. Very, very exciting the response we’ve seen globally from the missions around the world. I think, this is a long haul and we’ll take it all into the finish line.

Wikihospitals — You also have the power of relatives lobbying for better treatments… they are are becoming willing to argue and look around see what else is available.

David — You raise a great point… — those advocacy groups play a major role in expressing the voice of the patient. In Australia, they’re active. They just don’t have the power and the money that you see in the UK or the US… The Epilepsy Foundation is very big in the States. It’s just tough in Australia, because people don’t give enough money to support these charities. They’re spending too much on horse racing and gambling… where as, actually providing money… will help them and their families and ultimately the community. It’s a shame you don’t see more of that sort of giving in Australia.

“Get prepared to fail. Because it is going to happen time and time again.”

Wikihospitals — Do you have words of wisdom for Australian entrepreneurs?

David — First of all, (in) biotech’s… Australia’s had limited success. It’s (now) med tech… medical devices…that’s the key thing you hear anywhere in the world.

First of all, it’s your management team. I’ve got two people in the US, two people in the UK and one in Portugal. Right? And why I got those people is because they’re the best around. That’s the first thing.

Secondly, your investors. You need investors that are going to give good value, not just money. Because there is good and bad money. Some investors can drive you nuts. They can ask for the wrong terms for investment. That can do a lot of harm.

The third thing is the board of directors and the advisory boards. Get the best people in the world that understand from day one you’re in a global community that’s trying to provide global resources. …that… helps you to identify your market…

So… I’d say, (don’t just concentrate on) the Australian market… cause that’s really messy and complex. That’s probably the biggest challenge… Then the other thing is putting the components together to make sure you’re setting the company up right.

“Focus on the need. Forget about building a product and then forget what you’re going to do it for.”

David — Even though you’ve heard me talk technology, as I said before, I’m driven by the clinicians, I’m driven by the clinical need. I can generally find a technological solution, even if I have to compromise sometimes, that will serve that purpose. That’s the key thing.

Wikihospitals Okay. So, look for the problem to solve, rather than the product to present?

David — Absolutely.

Wikihospitals — Do you think that you have some way that we could improve what we support or encourage entrepreneurs in Australia?

David — Yes, look investments a big, big issue. I think the Australian governments don’t have long term views of this industry, as you see in countries like the US and Israel, and now in the UK. But, I think we need more Angel Investors that understand healthcare because a lot of them come from engineering backgrounds don’t understand clinical. We know there’s a lot of wealthy doctors out there, it would be great if they could set up some sort of consortium.

In general, I think, (we need) the high net worth people. If they could be a little bit more risk taking, that would make a huge difference. They’ll actually end up in better returns. It would make a big difference on the local environment in terms of successes. There’s a lot of activity going on, but most of (it) will fail. Largely (because if you) don’t have the management team, you don’t have the money.

Wikihospitals — When do you think your product might be coming to Australia?

David — Keep your fingers crossed, one and a half to two years could well be in Australia as well.

Wikihospitals — Could we say that neurologists if they’re interested could contact the Royal Melbourne Hospital, because some (the) trials are going through there?

David — Yes. I think you can. They’re very busy. It may be easy just to contact me via our site or on info@niesm.com and then we’d be happy to refer them to those clinicians. I’m happy to do a bit of a screening for them.

Wikihospitals — Well, thank you very much for this interview David. We look forward to your product coming onto market and giving people with epilepsy and their families much, much, much more diagnosis and treatment.

David — Thanks for the opportunity Delia.

© Wikihospitals 2017

New drug target confirmed for chronic pain treatment

Chronic pain can lead to a decreased quality of life in patients who suffer from long-term conditions that can lead to it, including sciatica, cancer, and rheumatoid arthritis. The mechanisms that often lead to chronic pain are also multi-factorial and complicated which is why pain management can be difficult in these patients.

Inadequate pain relief, however, can lead to a decreased quality of life overall in chronic pain patients. General pain relievers, even more potent like morphine, often still prove to be inadequate, especially in those with more severe conditions, like cancer patients. This is why establishing new therapeutic options is so urgent in these treatment-refractory patients.

A research group at Hiroshima University observed that previous research had only looked at one pain model at a time and emphasized the importance of covering multiple molecules that mediate chronic pain.

This led them to look into a type of cell receptor, REV-ERBs, that previous research showed sends chemical signals inside the cell to block the production of certain genes regulating pain and inflammation-causing molecules in the body.

“Nobody checked the effect of REV-ERBs agonist [stimulator] on nociceptive behaviors [pain reactions] or chronic pain so first we checked the effect of REV-ERBs agonist on chronic pain,” explains Assistant Professor Yoki Nakamura, Department of Pharmacology, Graduate School of Biomedical & Health Sciences, Hiroshima University.

REV-ERBs agonists were used to determine if activating the REV-ERBs in astrocytes, a type of spinal cord cell, resulted in pain relief in chronic pain mice models. It was found that untreated mice with the same type of chronic pain felt more pain compared to those that were treated with a REV-ERC stimulator when they were touched with a filament on their hind paw.

Based on the results, the researchers at Hiroshima University believe that this new drug target may lead to potential new therapeutics being developed for patients who suffer from chronic pain.

For more information, please visit ScienceDaily.

Questions: How frequently do you counsel patients with chronic pain? Does this new research sound promising in terms of decreasing pain in chronic pain patients?

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