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Inside the Patient Entrepreneur’s Mind: Ira Spector, PhD

Ira Spector Blog

Managing a chronic illness is challenging, whether it is your own or a loved one’s. Starting and running a business also poses unique challenges. If you struggle with a chronic illness, have started a business, or want to start a business, this blog series can help guide you. “Inside the Patient Entrepreneur’s Mind” offers key insights into chronic disease and mission-driven entrepreneurship by some of the most innovative patient entrepreneurs in the world. 

Ira Spector, PhD is CEO & Co-Founder of SFA Therapeutics. He is also a finalist of the 2019 Lyfebulb-Helsinn Innovation Summit & Award in cancer.

As a patient entrepreneur, can you describe your personal experience with cancer and how this experience drove you to innovate the space?

I had two parathyroid tumors removed in 2013 and I was very lucky that they were both caught early and localized. The only problem I had was a sequela of cancer treatment, because there is almost always other damage that occurs. For me, my body was overproducing calcium after cancer treatment so I have calcium deposits in all of my joints as well as my heart valve that required a lot of follow up cardiac care. In my case, I feel lucky that my tumors were caught early. Unfortunately, I have a lot of other personal connections to cancer and other illnesses that resulted differently than my case. My mother and father both had cancer, we lost my father-in-law to colon cancer and my brother-in-law to what we think was glioblastoma. I was also heavily influenced growing up with a seriously ill sibling in terms of guiding me to do what I do now. I’m fairly unique because I am in the drug development industry.  In terms of cancer, specifically, when I found the technology that was the basis for SFA, it was supposed to start as an anti-inflammatory platform. Almost  by happenstance, after looking at the pathways downregulated by this anti-inflammatory platform, I found them to also be oncogenes. When I discovered the downregulating effect of this anti-inflammatory platform on certain oncogenes, I learned that there were other cancers with an inflammatory component that we could go after with this therapy. 

What makes SFA Therapeutics unique and how does it meet an unmet need of the cancer community?

Cancer patients live the rest of their lives looking over their shoulder waiting for the cancer to come back—we think our drugs are the metaphorical umbrella to prevent recurrence. Other than addressing environmental factors like smoking, cancer prevention doesn’t get a lot of attention on the Big Pharma or development side. What we’re saying is wait a second, there are millions of people who have already been treated and now they are just living in fear—what about them! We think we have an approach to reach this community of people. With the exception of certain type of breast cancer, there are very few cancers where other drugs are used to prevent relapse recurrence. At least in terms of CLL and ALL, the path to reduce recurrence comes from this drug we are developing at SFA. We think there is a whole generation of drugs that are very safe and non-chemotoxic to help prevent relapse.

Traditional treatment of cancer has been based on the theory that cancer cells grow more rapidly than normal cells. Agents like chemotherapy or radiation have been used to kill those cells, while also killing healthy cells in the process, to reduce the cancer burden. Our thesis differs in that we believe certain cancers have an inflammatory component and there is a way to control that inflammatory response in the cell. Our drugs are designed to prevent recurrence of tumors by reducing chronic inflammation.

Are there any other unmet needs of the cancer community that you think take priority in working to address? How are patient entrepreneurs well-suited to meet these needs?

Cancer is all too often treated with the ‘let’s just get it out’ mentality and we need a more integrative approach involving the family and disease experience. There are others working on this too, and although we have to be focused with resources, we recognize that there clearly needs to be an integrated approach that improves cancer aftercare. Although we are focused on drug development at SFA, we as Patient Entrepreneurs recognize the general needs of the community are huge. There is a lot of stigma and psychology that could be addressed here. I have a tremendous sensitivity to the broader issues here and I recognize that is also not a very well met need societally. 

Where do you draw your inspiration and motivation from to keep forging ahead as an entrepreneur in the healthcare industry?

Patients. I’m an industry veteran involved in household name drugs. That being said, I get up every morning thinking about patients who haven’t been treated and patients who could’ve been treated by drugs that failed. The inspiration comes from the fact that we are not done and there is still a lot left to do. I know that has become my mantra now in the industry, but it has always been my driver. Getting out of the lab or business setting and going out into the field to talk to physicians, patients, and families—that’s why we are here. Almost everyone who gets into this have personal connections—both of my co-founders have personal connections. It’s just that simple. Pharma and biotech are rated the lowest of the low in public opinion polls, even though most of us who work in this industry are trying to change the world. Despite making a fair amount of progress, we are all vilified based on perceptions about things like costs and the opioid epidemic. We just soldier on regardless of the public opinion in the hopes of changing public understanding of how hard we work to help patients. 

Lastly, what do you do for fun to manage the stress of running a business as both a cancer survivor and an entrepreneur? Do you have any similar advice on work-life-disease management balance to others out there thinking of starting a business to meet an unmet need of a chronic disease patient community?

There are two activities that I engage in. In the summer, we move to the beach so I average 3-4 miles per day walking on the beach. I’m also an active swimmer. However, my other big passion is restoring antique cars. The goal isn’t to finish, but to just decouple by putting on the stereo (I’ve worked on a car for 5 years). On a bad day, if I can’t get anything done on a car because of the calcium deposits in my hands, I walk away and do something else like walk or swim. My advice to other budding patient entrepreneurs is that you need to have activities that totally decouple from what you’re doing and enable you to have a recreation that clears your mind. Do something completely different in order to unplug. You just need to have something, whether it’s music or sports, to decouple from the stress of the day.

Ira Spector Car Restoration

Wearing a Diabetes Medical ID On-The-Go!

Medical ID Bracelets

Living life on-the-go can be fun and busy, however, doing so with a chronic illness requires a few extra steps and planning along the way.

 

Hi, my name is David and I have been living with Type 1 Diabetes for 10 years now. I was diagnosed at the age of 11 and let me tell you… I have been through a lot. In living with this disease, I have been able to experience so much and learn from my mistakes. In doing so, I have come to realize that as a diabetic, I am one of those who should wear a medical ID and why it’s important for all life’s experiences.

For years on end, I never wore a medical ID bracelet. I could never find a bracelet that I simply liked or wanted to wear daily. When I became a part of the Diabetic Online Community (DOC) back in 2014, I was exposed to several different people who shared the same struggle. I also saw a variety of amazing brands and companies who understand this struggle and have found ways to make ID bracelets, dog tags, necklaces, and more so much nicer and pleasing to the eye and the patient. I own several different medical ID bracelets, I think when one finds their style with Diabetes, it’s always nice to have options and create your own look, which is why owning multiple forms of emergency ID that go with different looks is a great idea!

I have mentioned several times on my Instagram, @type1livabetic, that when wearing my personalized Paracord bracelet from American Medical ID, I felt so very safe. I felt as though if anything Diabetes related could go wrong, I would be prepared. On my engraved bracelet, my name, condition, and emergency contact information were all located on a small piece of metal, attached to the Paracord bracelet. At a recent trip to Disneyland with a large group of people who also had Type 1 Diabetes that could vouch for me if there were to be an emergency, I still encountered times in which I was alone at the park (walking to and from my car, walking to meet the attendees, or simply stepping to the side to grab a snack), rest assured, I was confident with my Diabetes at the time.

So why is it so important to wear a form of medical alert jewelry for Diabetes? Well, not to get too dark or technical, however, the fact remains that we do have Type 1 Diabetes that does come with some symptoms and consequences. If our blood sugar drops significantly low, we could pass out and become unconscious or go into a coma. Same with high blood sugar, if we are severely high and go into DKA, we could in fact experience some symptoms that could limit our ability to function, which can prevent us from acting in the moment to get help. Say you were in public, alone, and you experienced one of these symptoms, if you were wearing a medical ID, someone nearby would mostly likely come to check for various hints or signs on you if something doesn’t look entirely right and search for an alert jewelry in particular sites on the body: wrists, around the neck, tattoos, etc.

In being diagnosed with any chronic disease and being told you have to take extra care of yourself can be a lot, however, allowing yourself some relief by wearing a form of ID can truly reduce a lot of the stress surrounded by various diseases. One should never leave the house without some form of ID as you never know when these emergencies could happen.

American Medical ID Healthy Packing List

The CDC includes having a form of medical identification such as alert bracelets, necklaces, or wallet cards as part of a healthy travel packing list.

I believe that some may also feel safe in knowing that they have a medical ID card in their wallet as well, for added peace of mind. One should also wear a form of ID at home, just in case. For those who live alone, I understand that it may feel as though you are not in need of wearing an ID at home as you will be alone, but that could just be the very tool that can keep you alive, say you have an emergency, it could be that neighbor walking by and seeing something isn’t right that could barge in and save your life and being able to identify you have a particular medical condition that needs attention.

We each have our own busy lives that takes up so much time and mental focus away from our health, which is why wearing medical alert jewelry can protect us as we are on the move, daily. School, work, the playground, a coffeeshop, wherever you may be, ID is necessary. No matter how old the patient is, whether a child, teen, adult, or elder, wearing a medical ID all the time can protect us from the dangers of our diseases and more.

 

Live well,

David

The Implications of Using CBD for Chronic Conditions: Here’s What We Know

Cannabidiol (CBD), a non-intoxicating compound in cannabis, has become a popular alternative to pharmaceuticals. CBD users can sometimes find relief from their conditions without harsh side effects. 

41% of cannabis users surveyed report swapping out other medications completely in favor of cannabis, while another 58% use cannabis and other medication or alternate between them,” researchers stated in a survey by Brightfield Group

While CBD may be a beneficial alternative for chronic conditions, it’s important to consider the implications of using CBD before changing your current regimen.

Diabetes

Studies have suggested that inflammation has a correlation with insulin resistance. This may be the result of the body not moving sugar from the bloodstream into cells, causing excessively high blood sugar. Obesity-related inflammation particularly limits glucose metabolism, resulting in high blood sugar. 

Researchers still don’t know exactly how CBD improves insulin resistance, but often credit it to the compound’s anti-inflammatory effects

According to a report on Type 1 diabetes from the Diabetes Council, “CBD can save insulin-forming cells from damage so that normal glucose metabolism can occur.”

It’s important to note that most claims being made are based on studies with animals, not humans. Using CBD to treat diabetes without more substantiated research and medical oversight could be dangerous. Until further human studies are conducted, CBD can’t be considered a direct treatment for diabetes. 

However, the anti-inflammatory effects of cannabidiol may be beneficial for managing secondary symptoms from the disease. For example, CBD has neuroprotective qualities and may prevent retinal damage.

Cancer

While there is anecdotal evidence of successfully treating cancer with CBD, no definitive studies can back this up. However, we do know that CBD plays a role in cancer prevention and seems to have anti-tumor effects. In a 2012 report, researchers explained, “Evidence is emerging to suggest that CBD is a potent inhibitor of both cancer growth and spread.”  

The U.S. National Library of Medicine explains that CBD is anti-proliferative, meaning it can stop, slow down, or reverse the growth of cancerous tumors. It is also anti-angiogenic, meaning it does not support the generation of new blood vessels, specifically ones that allow cancerous tumor growth. Lastly, it is pro-apoptotic, which means it induces cellular suicide of cancerous cells. 

In addition to these cancer-specific effects, CBD may help patients dealing with pain related to cancer treatment, such as pressure on the organs and nerve injuries. Patients with cancer are commonly prescribed opiates to manage pain, but managing pain with CBD may be just as effective with fewer side effects.

Unlike opiates, which mimic our bodies’ natural endorphins, CBD actually encourages the production of natural endorphins by interacting with a neurotransmitter called anandamide. As a result, CBD is a non-habit-forming pain-reliever. 

It’s important to consider the legal implications before using CBD for cancer, or any other chronic condition. Hemp-derived CBD is legal across the United States, with specific guidelines per state. Idaho, Nebraska, and South Dakota have strict, conflicting rules regarding CBD, so caution should be taken if you live in those states. 

Whatever state you’re in, be sure to get high-quality CBD from producers who follow the guidelines of the law. 

Multiple Sclerosis

According to Neurology.org, “inflammation occurs in the brains and spinal cords of people with a specific kind of MS called relapsing-remitting MS.” CBD has been shown to protect against this harmful inflammation

In a 2011 study with mice, researchers found that CBD diminished axonal (nerve) damage and inflammation. CBD also reduced microglial activation, an inflammatory process that occurs in the central nervous system and is attributed to conditions like MS, Parkinson’s, and more. 

CBD may help users get relief from their MS without causing the sometimes intense side effects that come with pharmaceuticals. Still, CBD may cause some side effects that users should be aware of. Side effects may include:

 

  • Anxiety
  • Changes in appetite
  • Changes in mood
  • Diarrhea
  • Dizziness
  • Drowsiness
  • Nausea

Anxiety and Depression

The hippocampus, the most widely studied portion of the brain, is responsible for the regulation of memories and emotions. Researchers believe the hippocampus plays a major role in depression, and have found that this region of the brain can shrink or decay in those with depression.

Fortunately, the shrinkage does not have to be permanent. The brain is very regenerative and can bounce back as new neural connections are made. This process is known as “neurogenesis” and is an important process to target for antidepressants, contrary to the prior belief that they just work to increase serotonin. 

Where does CBD come in? Research has shown that cannabidiol signals a serotonin receptor called 5-HT1A. This receptor is responsible for controlling many neurotransmitters, and is also the target of some anti-anxiety medications, like Buspirone. Activating this receptor can encourage neurogenesis, and potentially relieve symptoms of anxiety and depression. 

While each individual case is unique, anxiety and depression tend to go hand-in-hand. CBD may encourage the neural regeneration necessary to find relief from either or both conditions. 

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) is caused by — you guessed it — inflammation. A 2009 study found CBD was beneficial for colitis, a form of inflammatory bowel disease. Researchers induced colitis in mice and tracked their gut inflammation, finding that “cannabidiol, a likely safe compound, prevents experimental colitis in mice.”

Another review found “this compound may interact at extra‐cannabinoid system receptor sites, such as peroxisome proliferator‐activated receptor‐gamma. This strategic interaction makes CBD as a potential candidate for the development of a new class of anti‐IBD drugs.”

If you’re considering using CBD with other medications, consult your doctor first. Much like grapefruits, CBD inhibits the cytochrome P450 enzyme, which can prevent drugs from metabolizing properly. 

CBD could also negatively affect the liver by increasing liver enzymes. A 2014 review of CBD saw changes in the liver function of 10% of the subjects, and 3% had to drop out of the study to prevent further damage. Again, consult with a doctor if you want to use CBD for a chronic condition like IBD but are worried about the effects on your liver.

The Bottom Line

Americans spend around $1,200 on prescription drugs each year, which is more than the residents of any other developed country. The price of pharmaceuticals has risen without any improvements or innovation, according to CNBC. This makes CBD an exciting avenue as a potential alternative to standard pharmaceuticals.

It’s important to remember that the effects of CBD will vary by person, and that a lot of the claims we hear about CBD are in relation to animal studies and not humans. It’s also important to be as informed as possible before diving into the complicated world of buying CBD.

Still, many people find success with CBD for their chronic conditions. 

 

Macey Wolfer HeadshotMacey is a freelance writer from Seattle, WA. She writes about natural health, cannabis, and music.

Lyfebulb and Celgene Announce Finalists for 2019 “Addressing Unmet Needs in MS: An Innovation Challenge”

Lyfebulb and Celgene Announce Finalists for 2019 “Addressing Unmet Needs in MS: An Innovation Challenge”

Finalist patient entrepreneurs recognized for potential of innovations in multiple sclerosis (MS)

Image at Celegene 2019 challenge

NEW YORK, May 10, 2019 /PRNewswire/ Lyfebulb, a chronic disease-focused, patient-empowerment platform that connects patients with industry to support user-driven innovation, and Celgene Corporation (NASDAQ: CELG) announced the 10 finalists chosen for the Lyfebulb-Celgene 2019 “Addressing Unmet Needs in MS: An Innovation Challenge.”

The following finalists will compete at the Innovation Challenge Summit on June 13, 2019, for a $25,000 monetary grant to further develop their proposed innovations:

Celgene Logo with tagline

  • Abilitech Medical, Shawna Persaud: Medical device intended to help people with MS with mobility challenges use their arms
  • AXS Map, Jason DaSilva: Web platform that allows users to locate, rate and review the accessibility of any location in the world
  • BeCareLink, Alan Gilbert: Predictive artificial intelligence (AI) digital therapeutics platform which remotely measures clinically validated assessments of cognition and motion to help improve quality of care and reduce costs for people with MS
  • C. Light Technologies, Inc, Zachary Helft: Neurotech and AI technology using eye motion measured on the cellular scale to monitor disease state in people with MS for treatment efficacy feedback
  • Dance4Healing, Amy Li: AI-powered telehealth live video platform which brings community, exercise and physical rehabilitation into the home to encourage healthy behavior change
  • Icometrix, Wim Van Hecke: AI-based brain imaging solutions to monitor disease progression
  • Leoplus USA, Kinza Kasher: Device and app which aims to support communications between patients and care partners
  • Loro co., David Hojah: Socially assistive companion robot for people with mobility challenges
  • Moodify, Kate Milliken: Web-based tool which builds communities, aims to reduce loneliness, creates searchable content moments and tracks the emotional journey
  • ThermApparel LLC, Bradley Dunn: Lightweight, comfortable and concealable cooling apparel for people with extreme heat sensitivity

“At Lyfebulb, we build communities of patients with chronic disease around a message of inspiration and hope for the future. Each of these patient entrepreneurs is inspirational, as they have taken their frustrations of living with their disease – or observing it in a loved one – and are working to turn those insights into business solutions to help members of the MS community live their daily lives more comfortably,” said Dr. Karin Hehenberger, CEO and Founder of Lyfebulb.

These finalists are being recognized as outstanding patient entrepreneurs – those who have been affected by MS as either a patient, loved one or support partner – whose companies are helping develop solutions to address an unmet need in MS. A “pitch session” will be held at the Challenge Summit, and a winner will be chosen by a diverse group of experts in the MS, healthcare and business communities. The panel of judges will include:

  • Tim Coetzee, PhD: Chief Advocacy, Services and Research Officer, National Multiple Sclerosis Society;
  • Adam Fine: General Partner and CEO, Windham Venture Partners;
  • Elizabeth Jones: MS Patient Ambassador;
  • Darin T. Okuda, MD, MS, FAAN, FANA: Director, Neuroinnovation Program, Multiple Sclerosis & Neuroimmunology Imaging Program, UT Southwestern Medical Center; and
  • Deneen Vojta, MD: Executive Vice President, Global Research & Development, UnitedHealth Group.

“We are excited to bring together these patient entrepreneurs, judges and members of the Celgene and Lyfebulb teams for an engaging and interactive summit,” said Terrie Curran, President, Celgene Inflammation and Immunology. “Ultimately, we hope to foster discussion about ways to advance innovation in the space and look forward to awarding this grant that will help support people with MS and their families.”

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often debilitating disease that affects approximately 2.5 million people worldwide. In MS, an abnormal response of the body’s immune system causes inflammation and damage to myelin—the substance covering nerve fibers—in addition to damage to nerves themselves. Signs and symptoms are varied and can pose significant challenges in daily life.

About Lyfebulb
Lyfebulb is a chronic disease-focused, patient empowerment platform that connects patients and industry (manufacturers and payers) to support user-driven innovation. Lyfebulb promotes a healthy, take-charge lifestyle for those affected by chronic disease. Grounded with its strong foundation in diabetes, the company has expanded disease states covered into cancer, inflammatory bowel disease, multiple sclerosis, and depression/anxiety.

See www.lyfebulb.com, Facebook, Twitter, Instagram, Karin Hehenberger LinkedIn, and Lyfebulb LinkedIn.

About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

For inquiries, please contact:

Lyfebulb
Karin Hehenberger, M.D., Ph.D., CEO
917-575-0210;

The medical field is ripe for automation

dialysis machine
A nurse prepares a dialysis machine.

Radu Sigheti/Reuters

As a neonatologist, I worry about patients with pulmonary hypertension. This unforgiving disease, sometimes seen after premature birth, can end with sudden death from constricting blood vessels in the lungs. One minute a baby in the neonatal ICU may be sleeping comfortably; moments later, doctors and nurses are giving chest compressions and rescue medications.

A pulmonary hypertension crisis, as these frightening episodes are called, starts with a drop in the blood oxygen level. That drop triggers a monitor to beep. It’s up to the nurse to hear the sound, come to the bedside and take action.

The first and most effective step in stopping a pulmonary hypertension crisis is simple: Give oxygen. But a nurse caring for another patient might be delayed for 30 seconds, and the loss of that time can lead to brain injury or death.

In an age of self-driving cars and 400-ton airplanes that can land themselves in blinding fog, it makes no sense that hospitalized patients are surrounded by lifesaving machinery that can be activated only by a person pressing a button or turning a knob.

Modern transportation augments human judgment and reaction times with a computer’s superior ability to continuously respond to dozens of fluctuating variables. Yet in medicine, safety remains stubbornly reliant on human intervention.

FDA regulation impedes innovation

My patients with pulmonary hypertension are often attached to a respirator with adjustable oxygen settings. The respirator sits inches below the monitor that indicates how much oxygen is in the blood. But the two machines can’t communicate with each other. If they could, it would be possible to increase the flow of oxygen automatically the moment a crisis is detected.

In 2009, engineers developed just this kind of closed-loop respirator and introduced it in several hospitals as part of a feasibility study. It increased the time premature babies spent at a safe oxygen level by more than two hours per day. But no biotechnology company has marketed the idea.

There are other examples of automated systems with unrealized potential to save lives, and not just in the neonatal ICU. Software that scans an ECG for subtle heartbeat variability can identify patterns – undetectable to the human eye – that indicate an elevated risk of heart attack. Hospital beds that play audible feedback during an emergency promote more effective CPR. Yet patients are not benefiting because neither of these tools has been commercialized.

Why haven’t these innovations attracted the industry backing necessary to make them widely available?

One reason is that the process of getting FDA approval for new devices – particularly those deemed “life-sustaining” – is often even more complicated and expensive than getting approval for drugs. In the Journal of Public Economics, Harvard…

Study finds significant decrease in cardiovascular diseases among individuals with diabetes

The incidence of cardiovascular diseases in Sweden has decreased sharply since the late 1990s. These are the findings of a study from Sahlgrenska Academy which included almost three million adult Swedes. In relative terms, the biggest winners are persons with type 1 and type 2 diabetes.

“This is a huge improvement and a testament to the improvements in diabetes and cardiovascular care throughout Sweden,” says Aidin Rawshani, medical doctor and doctoral student in molecular and clinical medicine.

The study, which was published in The New England Journal of Medicine, shows that the incidence of cardiovascular diseases and deaths among individuals with diabetes in Sweden dropped significantly between 1998 and 2014. The population in general exhibited the same trend, albeit to a smaller extent.

Among persons with type 1 diabetes, with an average age of 35 years, the incidence pf cardiovascular disease was reduced by 40 per cent during the period in question. In the control group of persons of similar age but without diabetes, the decrease was 10 per cent.

Among individuals with type 2 diabetes, with an average age of 65 years, the incidence of cardiovascular disease decreased by 50 per cent. Among control persons of similar age without diabetes, the decrease was 30 per cent.

Surprising results

“We were surprised by the results, specially for persons with diabetes. Some smaller studies in the past have indicated that numbers were improving, but nothing of this magnitude,” says Aidin Rawshani.

In total, approximately 2.96 million individuals were studied, of which 37,000 had type 1 diabetes and 460,000 had type 2 diabetes. The results of the study are based on linked processing of data from the National Diabetes Register, the Cause of Death Register and the part of the Patient register that concerns inpatient care.

In addition to matching by age and gender, the groups that were compared were also matched geographically using register data from LISA (the longitudinal integration database for health insurance and labor market studies).

The deaths that took place in the groups during the study period were almost exclusively related to cardiovascular disease. Individuals with diabetes have previously shown to suffer a risk of cardiovascular disease and early death that was between two and five times as high as in the general population.

Better risk control

“One of the main findings of the study is that both deaths and the incidence of cardiovascular disease is decreasing in the population, both in matching control groups and among persons with type 1 and type 2 diabetes. One paradoxical finding is that individuals with type 2 diabetes have seen a smaller improvement over time regarding deaths compared to the controls, while persons with type 1 diabetes have made an equal improvement to the controls,” notes Aidin Rawshani.

The positive trends that have been observed in the study are most likely due to an increased use of preventative cardiovascular medicines, advances in the revascularization of atherosclerotic disease and improved use of instruments for continual blood sugar monitoring, and the fact that Swedish diabetes care has generally worked well with good treatment guidelines and quality assurance efforts.

“Out study and analysis does not include explanations of these trends, but we believe that it is a matter of better control of risk factors, better education patients, better integrated treatment systems for individuals with chronic illnesses and individual care for persons with diabetes. There is often an entire team working with a patient, ensuring that their needs are met,” says Aidin Rawshani.

Study finds significant decrease in cardiovascular diseases among individuals with diabetes
Study finds significant decrease in cardiovascular diseases among individuals with diabetes

The incidence of cardiovascular diseases in Sweden has decreased sharply since the late 1990s. These are the findings of a study from Sahlgrenska Academy which included almost three million adult Swedes. In relative terms, the biggest winners are persons with type 1 and type 2 diabetes.

For decades, American waistlines have been expanding and there is increasing cause for alarm. Researchers from the Charles E. Schmidt College of Medicine at Florida Atlantic University make the case that metabolic syndrome — a cluster of three of more risk factors that include abdominal obesity, high triglycerides, high blood pressure, abnormal lipids, and insulin resistance, a precursor of type 2 diabetes — is the new “silent killer,” analogous to hypertension in the 1970s.

How does type 2 diabetes develop? A team of researchers headed by the Helmholtz Zentrum München and the Technical University of Munich has come closer to finding an answer to this problem. The team examined the functional effects of exemplary genetic variations relevant for type 2 diabetes. Their approach can be applied to many clinical pictures.

According to current estimates, 20 to 25 million Americans have or will develop gallstones, representing almost 15% of adults. Although only a small percentage of individuals with gallstones develop symptoms, more than 700,000 individuals annually undergo surgical gallbladder removal and many more take medications to manage the condition or undergo stone-dissolving procedures.

Nearly half of all deaths in the United States in 2012 that were caused by cardiometabolic diseases, including heart disease, stroke and type 2 diabetes, have been linked to substandard eating habits, according to a study published in the March 7 issue of JAMA and funded by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.

A study from the Research Institute of the McGill University Health Centre shows that physician-delivered step count prescriptions, combined with the use of a pedometer, can lead to a 20 per cent increase in daily steps, as well as measurable health benefits, such as lower blood sugar and lower insulin resistance, for patients with hypertension and/or type 2 diabetes.

A new study led by American Cancer Society researchers in collaboration with leading experts concludes that physical activity should be routinely assessed during the doctor-patient encounter, and that clinicians should design in collaboration with their patients a detailed physical activity plan with goals that should be set and monitored.

Recently, dietary guidelines for the general…

Abbott’s bittersweet week: Amended $5.3B deal to buy Alere and a warning letter for St. Jude Medical

big fish acquisition deal

More than one year after Abbott Laboratories offered $5.8 billion for Alere, the stormy romance of the diagnostic testing company, punctuated by lawsuits, has reached a conclusion with Abbott agreeing to acquire the business for the reduced price tag of $5.3 billion. But this week Abbott Labs also received a warning letter from the U.S. Food and Drug Administration over

The revised terms of the deal seem to reflect the suspicions of Divyaa Ravishankar, a diagnostics market expert at Frost & Sullivan, that the lower priced deal could well have been Abbott’s goal all along. She made that observation soon after Abbott filed a complaint with a Delaware court to force a termination of the proposed $5.8 billion deal to buy Alere. In a press release regarding the December complaint, Abbott cited some of the factors that motivated the complaint such as the permanent recall of an important product platform and the government’s elimination of billing privileges for an Alere division.

In December, Ravishankar commented on those notes in an email:

“I have a feeling Abbott is hinting at the fact that they overpriced this company.”

The revised terms of the deal mean that Abbott and Alere will drop their lawsuits against each other. The deal is expected to close in the third quarter of 2017.

Despite the week ending on a high note for Abbott, a warning letter from the U.S. Food and Drug Administration drew attention to issues at another Abbott acquisition — its $25 billion purchase of St. Jude Medical. The letter is addressed to Michael Rousseau, the president of Abbott’s cardiovascular device division and a former CEO of St. Jude. The letter took issue with St. Jude’s handling of faulty batteries for its Fortify, Unify and Assura defibrillator lines, and a subsequent recall of the devices. The FDA also took issue with the company for failing to notify its management and advisory board that the battery failures led to one death:

Your firm completed its…

U of Miami Health System, Syapse join forces for cancer care

CANCER Word Art

Precision medicine.

The phrase doesn’t fall on unfamiliar ears in the healthcare world. But now it’s getting an extra bit of attention with the launch of a new partnership.

Sylvester Comprehensive Cancer Center, which is part of the University of Miami Health System, and Syapse, a Palo Alto, California-based software company, have teamed up to create a precision medicine initiative specifically focused on cancer care.

Physicians at Sylvester will be able to use Syapse’s platform to give patients more personalized care based on their clinical and molecular information.

“We bring all the data together for the physicians so they can understand what’s going on with the patient,” Jonathan Hirsch, president and founder of Syapse, told MedCity in a phone interview. “We have a decision support framework and a quality improvement framework so we can track the patient’s outcomes.”

With all the buzz surrounding precision medicine, now seemed like a better time than ever to launch the partnership.

Dr. Jonathan Trent, associate director of clinical research at Sylvester and professor of medicine at the University of Miami…

Do Crystals Actually Work? A Spiritual Healer Explains

Chances are you’ve been hearing about crystals or seeing them on your Instagram. Crystals are probably the trendiest wellness practice of the moment, but we wanted to learn more about them — sure, they’re beautiful (just look at this water bottle!) . . . but what do they do? Do they work? Is there proof?

So many questions, so many crystals, so little time. Crystals purportedly can help with so many aspects of your mental and physical health, so let’s get into it and explore what crystals actually do and how they can impact your well-being every day.

What Do Crystals Do?

According to crystal healer and therapist Mytrae Meliana, MFT, CHT, they do quite a bit, everything from improving your energy and mood to making you more creative and clearing your head for meditation. “Crystals are high-vibrational beings that work on multiple levels of your body: physical, emotions, mind, energy, and spirit,” said Meliana. Among many things, crystals can . . .

  • Improve energy. Crystals “are used to cleanse, rebalance, and activate your chakras (or energy centers).”
  • Enhance happiness. “They amplify your thoughts and emotions, so when you think positive thoughts and feel positive emotions, they help you feel even better.” Sounds wonderful, right?
  • Better meditation. “When you meditate, crystals support your consciousness, so you rise effortlessly to your natural spiritual state,” said Meliana.
  • Heighten creativity. Writer’s block? Drawing creative blanks? Try crystals. “When you create, they help you tap into your inspiration, flow, and focus.”
  • Reduce negative energy. Like air purifiers, but for your emotions. “As natural purifiers, they absorb negative energy and transmit positive energies so they’re wonderful to have in your home or work space, as they bring…

Why tech giants are claiming space in healthcare

From cloud platforms for medical data and hospital smart rooms to artificial intelligence and patient-engagement technologies, the giants of the digital world are threatening to disrupt healthcare.

Leading the pack is IBM and its centerpiece offering Watson Health. In just the last six months, the company has announced major initiatives into healthcare including a partnership with clinical consultation provider Best Doctors to add Watson’s cancer suite to employee benefits packages, a population health management alliance with Siemens Healthineers and an effort linking IBM’s PowerAI deep learning software toolkit with NVIDIA’s NVLink interconnect technology. The PowerAI is already being used improve diagnoses and care plans by sifting through patient data.

In October, Big Blue announced a $200 million investment in its Watson Internet of Things global headquarters in Munich, Germany. The money will support a series of IoT “collaboratories” aimed at bringing researchers, engineers, developers and entrepreneurs together to work on novel healthcare and other solutions.

Growing field of players

Apple has also more hinted at plans for a major thrust into healthcare, with high-profile hires and partnerships with large healthcare systems like Beth Israel Deaconess Hospital and Scripts Translational Science Institute. The company also acquired personal health record startup Gliimpse, which hopes to advance interoperability by aggregating health data into a single digital patient record.

Meanwhile, Apple has a patent application for a wearable device that can measure electrocardiographic information across different body areas of provide doctors with actionable readings. A series of emails between Apple and the Food and Drug Administration also shed light on several regulated products Silicon Valley firm is developing.

Microsoft is also expanding its footprint in healthcare with its analytics capabilities. Since jumping into the wearables market in 2014, the company has teamed with Twist BioScience on the capabilities of DNA digital data storage, collaborated with the medical community on numerous health research projects and joined forces with the University of Pittsburgh Medical Center to create innovative care delivery products. And just this week, Cigna announced it has leveraged Microsoft’s HoloLens technology to for interactive game-based health screenings.

And last month, Samsung waded into the digital health space via a partnership with American Well that leverages the Korean tech firm’s consumer electronics with American Well’s Exchange platform to enable providers and payers to connect and share telehealth services online. The company is also launching an IoT senior care solution called Breezie.

Leveraging technologies

Driving these and other large, multinational electronics companies is demand for data-driven information and the shift to value-based models of medicine and payment.

“Healthcare has been labeled as ‘ripe for disruption’ for years, but the combination of government mandates and regulations, technological advancements and financial incentives of the last decade has seemed to finally get the needle moving,” Derek Spearing, senior manager at Top Tier Consulting tells Healthcare Dive. Add that to the wave of health IT startups in recent years, and “healthcare is cool again,” he adds.

One of the things…

Rapid patient recruitment and reduced trial costs: is LDS the answer?

An interview with Professor Martin Gibson, NorthWest EHealth Chief Executive, conducted by April Cashin-Garbutt, MA (Cantab)

What is Linked Database System (LDS) technology and why has it been developed?

LDS stands for Linked Database System, which essentially describes what it does. Our LDS technology uses multiple sources of information from hospitals, GPs and pharmacies. However in the future this information could also come from other health data sources e.g. your smartphone, Fitbit etc.

The LDS is a platform that allows information to be gathered from all these different sources and puts it all into one place. It can be used to analyze the outcomes of clinical trials.

We started developing the LDS for the GSK (GlaxoSmithKline) sponsored Salford Lung Study (SLS). Development began in 2011 and over the years we have continually updated and improved the technology.

NorthWest EHealth

NorthWest EHealth (NWEH) is based at the Citylabs, which is a biomedical centre of excellence, located in the heart of Manchester’s Innovation District and within the largest clinical academic campus in Europe.

How does LDS technology integrate with patients’ electronic health records and what capabilities does this enable?

Everyone’s health records are spread across multiple systems and places. For example, medical information will be held by GPs, hospitals and pharmacies, and currently these records aren’t connected together. LDS takes the information from all of these very different kinds of systems and compiles it into one record, which can be used to monitor what’s happening.

However, it’s a bit more sophisticated than that. As we are using it to run clinical trials we have to be absolutely sure that when we take information from one of these different places and move it around and process it, that we haven’t changed the information in any way. Therefore, we validate every single part of the process. That makes it considerably more complicated but it means that you can absolutely trust the information you’ve got.

How do you make sure the information is secure?

We keep data as secure as we possibly can by using encryption and keeping everything behind the NHS firewall. All the data within the LDS remains within the secure NHS N3 network and is afforded the same security as patient healthcare records. Access to this data is tightly controlled. We also carry out penetration testing, to check for vulnerabilities in our systems that could be exploited. Having ISO 27001 certification at NWEH also means that we have robust security standards when handling patient information.

Can you please outline how LDS was used in the ground-breaking Salford Lung Study?

When we wanted to set up the Salford Lung Study the whole idea was that we’d have as little interference as possible into the everyday lives of those participating – and that’s really different to a normal clinical trial, which can be quite intrusive with multiple visits to clinics.

We wanted to be able to see a person at the beginning of the trial, get their consent and all the things that you would normally do, and then not have to see them again until the end of the trial, which was 12 months later.

Over that 12-month period the person could be receiving a medicine that was unlicensed at that time, i.e. it was still in the clinical trial phase. So we had to be absolutely certain that we could monitor the safety and the outcomes in close to real time. That’s why we had to build LDS as there was nothing in existence that could already do that.

To be perfectly safe we needed information from all of those different sources – GP, pharmacy, hospital – to make sure that every time somebody touched the NHS, we knew they were okay or we knew if they were having problems, and we could do something about it if they were.

What we built was in operation from day one, but we’ve refined it considerably as time has gone by.

Why was the inclusion of a broad population of patients so important for this trial?

You hear a lot of people talking about ‘real world’ studies. Our LDS technology links consenting patients’ electronic health records (EHRs) across all of their everyday interactions with pharmacists, doctors and hospitals, enabling the collection of real-world data, but with minimal intrusion.

To give you an idea, the first trial that we published in the New England Journal of Medicine in September was on Chronic Obstructive Pulmonary Disease (COPD). COPD is a condition that affects a lot of people, but if you look at standard kinds of clinical trials for COPD and at the inclusion criteria and the exclusion criteria, then only about seven per cent of people that have the condition would ever get into a typical COPD clinical trial.

That means that more than ninety per cent of people who will eventually be prescribed the drug have never been exposed to that kind of medicine – so standard clinical trials do not reflect real-world patients.

We simply didn’t know what benefits most people with COPD would get from this medicine. The idea of this study was to show that the medicine was effective across all the different kinds of people that have COPD. We wanted to show how effective it was in a whole population, not just the seven per cent that might get it in a standard clinical trial setting.

It has been reported that LDS technology could enable drugs to get to market faster. What is the reasoning behind this claim?

This is definitely where the technology is heading. What we’ve discovered by getting information directly from the medical records is that there’s no transcribing of that information. It’s not necessary for somebody to sit down and take information from the GP and copy it into a different report form and then submit it. There’s a lot of time saved doing that.

The other thing we’ve learned is that the safety monitoring system that we built for this is actually much better than anything we use right now. It’s much faster so we can receive messages in almost real time, telling…

Benefits of statin therapy outweigh diabetes risk

In a commentary published in The American Journal of Medicine, experts wrote that the CV benefits of statins outweigh any diabetes-related risk they may present.

Charles H. Hennekens, MD, from the Charles E. Schmidt College of Medicine at Florida Atlantic University, Boca Raton, and colleagues wrote that several studies show that the risk for diabetes from statin therapy is outweighed by the benefits in both treatment and prevention of MI and stroke.

“The totality of evidence clearly indicates that the more widespread and appropriate utilization of statins, as adjuncts, not alternatives to therapeutic lifestyle changes, will yield net benefits in the treatment and primary prevention of [MIs] and strokes, including among high-, medium- and low-risk patients unwilling or unable to adopt therapeutic lifestyle changes,” Hennekens said in a…

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