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Doctors have duty to treat nonvaccinated children – Toledo Blade

September 2nd, 2017 9:44 pm

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Doctors have a duty to treat kids with parents who won't listen to their advice.

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We in the medical community believe wholeheartedly in the prevention of all illness, especially by vaccination.

Science and history continue to show that vaccination dramatically decreases both the mortality (death rate) and morbidity (severity of illness) of infectious diseases.

More than 98 to 99 percent of the general population agrees with those conclusions.

Yes, it is absolutely frustrating when parents refuse to follow our advice and protect their children. But, the law respects the right of a parent to not vaccinate his or her child, and we as health professionals should respect the law.

Our primary objective as health professionals is to protect children of all colors, religions, and backgrounds, whether we agree with their parents decisions or not.

But, there is a growing trend among us to discharge or kick out children from our medical practices because their parents have chosen not to vaccinate them.

There are two illogical arguments used in this decision to discharge these unvaccinated (or slow vaccinated) children:

1. Because parents do not agree with our recommendations to vaccinate their children, we can do no more for them, so we should wash our hands of the problem.

Yet, we dont do this with other families in our practice whose children are unhealthy as a result of a parents decision. When an obese child remains that way for months to years, despite our recommendations to improve his or her lifestyle, we do not discharge those children and families. We keep an open dialogue to continue to try and help.

When we tell parents over and over again that they should stop smoking; that second and third-hand smoke is a health risk for their children, and yet they continue to smoke, we do not discharge them from our practices. We keep an open dialogue.

How about the parent who decides not to complete all of the antibiotics that were given, because my child didnt need them? We dont discharge those families from our practice.

Obesity, parental smoking, and drug noncompliance comprise more than 60 percent of our patient populations. If we discharged all of these children from our practice just because they didnt do everything that we told them to do, wed be out of business.

2. Nonvaccinated children pose a risk to babies and other immuno-compromised children in our office.

In reality, the overwhelming majority of childhood infections occur in our homes, schools, day cares, churches, malls, restaurants, airports, amusement parks, and, yes, even in our hospitals; not in medical offices.

How will discharging these children from our medical home prevent an overwhelming exposure to the general population? It wont.

And, who will take care of these nonvaccinated children when and if they do become sick? Where will they go? Theyll go to the already busy emergency rooms and urgent cares where they will be exposed to not only other babies, but older children, adults, the elderly, and those with a weakened immune system (e.g., cancer/chemotherapy).

By keeping an open dialogue with these families, we can continue to emphasize the importance of preventative medicine (immunizations), as well as monitor their children for signs of infectious diseases. By keeping these kids in our practice, we know which children are vaccinated and which are not, and we can adjust office visit times (or keep them at home) to minimize exposure to those more susceptible infants and children.

The law protects the parents right to not vaccinate his or her child. If we dont like the law, then we should change it, not declare our own martial law. Our ethical duty is to protect all children, not turn our backs on some.

We, as health professionals, need to be objective and logical and prevent our emotions from affecting our decisions. To quote the philosopher, and physician, William James: A great many people think they are thinking when they are merely rearranging their prejudices.

Dr. Michael D. Pappas of Berkey is board certified by the American Board of Pediatrics in both general pediatrics and pediatric critical care medicine.

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What We Know About Medical Marijuana’s Effect On Heart Disease – The Fresh Toast

September 2nd, 2017 9:44 pm

Almost everyone knows somebody that has been effected by heart diseasestatistics show that coronary artery disease is the most fatal disease in the United States. To put this statistic into perspective, on an annual basis, one quarter of all deaths (or 600,000 yearly fatalities) in America are due to heart disorders. For the most part, individuals contract heart disorders due to unhealthy life styles and bad habits including: fatty foods, smoking, drinking, and sloth.

The term heart disease is an umbrella phrase generally used to describe symptoms related to atherosclerosis, which arises with the gradual amassing of fats on the walls of arteries and veins. Over time, with a consistently unhealthy diet and lifestyle, these fatty deposits can eventually restrict blood flow in the arteries to the point of heart attack. However, there are a few other forms of heart disease including heart failure, arrhythmia, heart valve problems, and hypertension. While the causes of atherosclerosis (lifestyle, etc.) can also be attributed to these other heart maladies, there are a plethora of other sources for them, including stress and genetic disorders.

As with a majority of medical applications for cannabis, legitimate scientific research into the herbs potential as a medicine for victims of heart disease is in its infancybut findings thus far are quite profound. For the most part, studies into the potential use of cannabis as a medicine for heart disease are related to both CBD and abnormal cannabidiol. For starters, studies have shown that CBD can be beneficial for heart disease victims as both a preventative and restorative medicine. Secondly, abnormal cannabidiol is potentially a wonder drug which can greatly help reduce the chances of heart attacks for atherosclerosis patients. Each of these fascinating compounds are worth exploring in more detail.

CBD has various theoretical medical applications for heart disease. To begin with, CBD has been shown to cause blood vessels to vasodilate, improving blood flow and reducing blood pressure. Point being, CBD can possibly be utilized as a preventative medicine for heart attacks, as it has the potential to help blood vessels restrict and move more efficiently. Doctors also feel that CBD can be used as an anti-arrhythmic which can reestablish normality in ones heart beat post heart attack.

Abnormal cannabidiol is a synthetically derived chemical which is related, on a molecular level, to the cannabinoids found within the marijuana plant. Also, abnormal cannibidiol shares the non-psychoactive properties of CBD, meaning that it does not get users high. The British Journal of Pharmacology reports that the application of abnormal cannabidiol in lab rats led to the widening of blood veins and arteries by relaxing muscles on their walls. Point being, findings show that abnormal cannabidiol, like CBD, can help lessen the chances of heart attacks by opening up blood flow within veins and arteries that would be otherwise restricted by atherosclerosis. It goes without saying that these findings warrant far more research into the potential uses of medical marijuana in relations to heart disease.

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The Heart and Medical Center welcomes new physician – Durant Daily Democrat

September 2nd, 2017 9:44 pm

The Heart and Medicine Center is pleased to announce that Sadaf Chaudhry, M.D., has joined Dr. Vivek Khetpal and Dr. Sangeeta Ketpal at The Heart and Medical Center as a full-time internal medicine physician on September 1, 2017. As an experienced internal medicine physician, she will specialize in a wide range of preventative and urgent care, including diabetes, skin diseases, cancer, lung disease and womens health. Dr. Chaudhry will also see and treat patients at AllianceHealth Durant.

Patient satisfaction is my top priority and I look forward to working with the residents of Bryan County, said Sadaf Chaudhry M.D. I hope to help the community make the right choices when it comes to staying well and living a health lifestyle.

Dr. Chaudhry earned her medical degree from Foundation University Medical College and completed her internal medicine residency at the University of South Alabama Hospitals in Alabama.

We are continuously working to enhance the patient experience at our practice, said Vivek Khetpal, M.D., The Heart and Medical Center, Dr. Chaudhrys commitment to high quality, patient-centered care makes her a welcome addition to our team. We know our patients and families will continue to receive the compassionate, personalized attention they have come to expect from us over the years.

To schedule an appointment, consultation or more information, please call 580-931-0500 or visit HeartandMedical.com. The Heart and Medical Center is located at 2701 W. University Blvd in Durant.

About The Heart and Medical Center The center was founded in 1997 by Dr. Vivek Khetpal specializing in Internal Medicine, Cardiovascular Diseases, Interventional and Nuclear Cardiology. He was joined by his wife, Dr. Sangeeta Khetpal, in 2005. They have been members of the Bryan County Community for over 16 years and strive to ensure that each and every patient that walks through the door is provided the best care possible.

Submitted by Heart and Medical Center.

Sadaf Chaudhry

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Discovery of a New Compound Turns on a Longevity Gene in Mice – Anti Aging News

September 2nd, 2017 9:44 pm

New compound provides an observed 90% increase in the activation of the gene's activation in the animal's heart tissue

The University of Hawaii Cancer Center has developed a compound called Astaxanthin that turns on whats called the FOX03 'Longevity Gene' in mice. Their scientists measured an almost a 90% increase in the activation of the gene in the animals' heart tissue.

In a joint venture, The University of Hawaii John A. Burns School of Medicine ("JABSOM") and Cardax, Inc. ("Cardax") (OTCQB:CDXI), a Honolulu based life sciences company revealed their promising results toward a new anti-aging therapy

Dr. Bradley Willcox, MD, Professor and Director of Research at the Department of Geriatric Medicine, JABSOM, and Principal Investigator of the National Institutes of Health-funded Kuakini Hawaii Lifespan and Healthspan Studies states, "All of us have the FOXO3 gene, which protects against aging in humans," said. "But about one in three persons carry a version of the FOXO3 gene that is associated with longevity. By activating the FOXO3 gene common in all humans, we can make it act like the "longevity" version. Through this research, we have shown that Astaxanthin "activates" the FOXO3 gene," said Willcox.

"This preliminary study was the first of its kind to test the potential of Astaxanthin to activate the FOXO3 gene in mammals," said Dr. Richard Allsopp, PhD, Associate Professor, and researcher with the JABSOM Institute of Biogenesis Research.

Experiments with the mice the control group was fed regular food and the other group was either a low or high amount of Astaxanthin compound CDX-085 provided by Cardax. As expected the group with higher doses gained the greatest increase in the FOXO3 gene in their heart tissue. "We found a nearly 90% increase in the activation of the FOXO3 "Longevity Gene" in the mice fed the higher dose of the Astaxanthin compound CDX-085," said Dr. Allsopp.

"This groundbreaking University of Hawaii research further supports the critical role of Astaxanthin in health and why the healthcare community is embracing its use," said David G. Watumull, Cardax CEO. "We look forward to further confirmation in human clinical trials of Astaxanthin's role in aging."

"We are extremely proud of our collaborative efforts with Cardax on this very promising research that may help mitigate the effects of aging in humans," said Vassilis L. Syrmos, Vice President of Research at the University of Hawaii. "This is a great example of what the Hawaii Innovation Initiative is all about -- when the private sector and government join forces to build a thriving innovation, research, education and job training enterprise to help diversify the state's economy."

Life sciences company Cardax, Inc. looks forward to further confirmation in human clinical trials of Astanxanthin's potential role as an anti-aging therapy.

Dr. Michael J. Koch, Editor withwww.WorldHealth.net and for Dr. Ronald Klatz, DO, MD President of the A4M has 28,000 Physician Members, has trained over 150,000 Physicians, health professionals and scientists in the new specialty of Anti-aging medicine. Estimates of their patients numbering in the 100s of millions World Wide that are living better stronger, healthier and longer lives. A4M physicians are now providing advanced preventative medical care for over 100 Million individuals worldwide who now recognize that aging is no longer inevitable.

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Kingsport Times-News: Dr. Joey Watson took a circuitous route to … – Kingsport Times News

September 2nd, 2017 9:44 pm

Before I went to work with the group at Eastman, I thought that Id save money and perhaps someday pursue a career as a physician. But life happens and I put those dreams on the back burner, Watson said.

Joey got married and when his wife became pregnant, he found himself going to her prenatal appointments and his interest in medicine was rekindled. As any engineer would do, Joey decided to test the waters by volunteering at local hospitals and shadowing doctors to see if his curiosity was still there and if his youthful plan was still viable. When he confided to those around him, including his wife, and sought their opinions about changing careers he received support from everyone.

I was encouraged to go visit the admission staff at the ETSU Quillen College of Medicine and they were just as encouraging as everyone else so I decided to apply to see if I would be admitted, he said.

The first of many doors opened when he was admitted to the Medical School at ETSU to begin his journey toward the medical field. I truly feel that God had his hand on this entire process, shared Dr. Watson. He opened each door along the way and I entered and passed through them all one step at a time. Being a physician is a calling and I believe Ive been led to the point where I find myself today.

Dr. Watson discovered that engineering and medicine are more alike than you might think.

Its about problem-solving, he explained. The main difference is that medicine has the human element that makes it more challenging and satisfying personally for me. Helping patients with health goals and preventative medicine helps them to achieve a good quality of life. For me thats gratifying.

Dr. Watson believes that his demeanor and training in communication skills developed by the ETSU College of Family Practice Medicine has provided him with the tools that set him apart from many other physicians.

Im a good listener, I am committed to understanding the patients needs and desires, and I work diligently to help them deal with difficult situations, he said.

As a non-traditional medical student, Dr. Watson found colleagues who were also older with whom he developed close friendships.

Its never too late to make a career change if youre curious and truly interested in another profession. I think people need to be willing to try new experiences especially volunteering opportunities so that they can determine if a career change is a good fit for them, he added.

Dr. Watson attributes much of his successful journey to his wife, Cindy, who he said, sacrificed a great deal throughout the entire process. She went above and beyond to care for our family during my long hours of residency. She was my biggest supporter whose encouragement kept me going.

Dr. Watson is now accepting patients at Mountain Region Family Medicine where he provides quality medical care for families and patients of all ages here in his hometown.

To schedule an appointment with Dr. Watson at Mountain Region Family Medicine's downtown Kingsport office, call 423-230-2801. The office is located in the Press Building at 444 Clinchfield Street.

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Skin imaging company moves from Arizona to Portsmouth – WMUR Manchester

September 2nd, 2017 9:44 pm

PORTSMOUTH, N.H.

A new company is calling the Granite State home, bringing a promise for dozens of jobs on the Seacoast.

It doesn't have a permanent home yet, but Digital Skin Imaging, a high-tech medical device company, is moving to Portsmouth.

So it's going to be really, really exciting in the next few years where this is going to go, said DSI chief executive officer Karleen Seybold.

DSI is a startup company, relocating from Arizona to New Hampshire, with national and international aspirations.

Through new technology called DermSpectra, DSI allows doctors to look at skin in an innovative way through full body scans.

The technology will help identify skin changes, including early detection of cancer and diseases.

It's really at the intersection of telemedicine, personal health care, preventative medicine, Seybold said. We're looking at trying to track your skin over time.

Company leaders announced the move at Portsmouth-based Medtronic, one of their partners.

Gov. Chris Sununu met with DSI earlier this year as part of his 100 Businesses in 100 Days initiative, an effort to attract companies to New Hampshire.

It's not a program that stops after 100 days, Sununu said. We're constantly talking to businesses to bring them in here. This is one of them.

DSI plans to hire at least 100 people and over the next five years, and intends to be a company worth more than $100 million.

We're going to be hiring engineering, software, sales and marketing, operations, we're going to be doing some manufacturing, Seybold said.

New Hampshire has a shortage of skilled workers, and Sununu said his office and the business community need to talk to new graduates outside the state to show them quality of life in the state and opportunities with companies like DSI.

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Science Weighs in On How Fat Raises Cancer Risk – Montana Standard

September 2nd, 2017 9:44 pm

FRIDAY, Sept. 1, 2017 (HealthDay News) -- Scientists have known for years that obesity can rise cancer risk, but how? Now, new research offers clues to how fat cells encourage tumors.

The issue is an important one, the study author said.

"Obesity is increasing dramatically worldwide, and is now also recognized as one of the major risk factors for cancer, with 16 different types of cancer linked to obesity," explained Cornelia Ulrich, of the Huntsman Cancer Institute in Salt Lake City.

To help prevent the disease, "we urgently need to identify the specific mechanisms that link obesity to cancer," she said.

Prior studies have already outlined several ways fat could play a role in cancer. For example, obesity increases inflammation in the body, which has long been associated with the disease.

Obesity can also affect cancer cell metabolism and undermine the immune system's natural defenses, which may help tumors to grow and spread.

Ulrich's team noted that the link between fat and cancer also hinges on cellular "crosstalk" -- changes in complex chemical signaling within cells. Finding ways to interrupt this "crosstalk" could lead to new ways to help prevent cancer, the researchers theorized.

In the new review, to be published Sept. 5 in Cancer Prevention Research, an international team of researchers looked at data from 20 existing studies. The studies were published over the past seven decades, and each focused on cellular crosstalk between fat cells and malignant tumors.

In several of these studies, certain fat cells -- known as "adipose stromal cells" -- were able to invade cancer lesions and then help spur the growth of tumors. The data also showed that obese people with prostate or breast cancer appeared to have more of these cells than thinner people.

Some types of fat cells are also more "metabolically active," releasing more substances that promote tumor growth, the review found.

Also, fat may be white, brown or beige, Ulrich's team noted. And these different types of fat each behave differently, depending on quantity and location in the body. For example, the review found that white fat tissue is linked with inflammation and worse outcomes for women with breast cancer.

The location of fat in the body also influences how it affects certain types of cancer, the review found. Fat tissue is usually adjacent to colon and rectal cancers, the research team noted, and it is part of the direct environment of breast tumors.

According to the team, future studies might help doctors figure out if it's possible to disrupt the processes that promote the growth of tumors by affecting nearby fat.

"We are just beginning to unravel the ways crosstalk occurs and the substances involved," Ulrich said in a journal news release. "The more we understand this process, the better we can identify targets and strategies for decreasing the burden of obesity-related cancer."

Two experts in obesity agreed that this type of research is important.

"Obesity is going to surpass cigarette smoking as the leading cause of cancer deaths," said Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City.

"The take-home message here is that proper nutrition and maintaining a proper weight is essential for successful preventative health," he said. "Obesity is not inert and impacts virtually every aspect of your body, and not in a positive manner."

Dr. Raymond Lau is an endocrinologist at NYU Winthrop Hospital in Mineola, N.Y. He said that "there has long been an association between obesity and cancer risk. There is growing evidence that inflammation is the common link between these two disease states, and this review article helps to strengthen this relationship."

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SECOND OPINION | The demise of a dietary dogma? – CBC.ca

September 2nd, 2017 9:43 pm

Hello and happy Saturday! Here's this week's round-up of eclectic and under-the-radar health and medical science news. If you haven't subscribed yet, you can do so here.

The buzz started even before the press releases went out. Something big is coming, our sources told us. Then on Tuesday, it happened.

A new study was released in The Lancet challenging the dogma of the diet-heart hypothesis. For decades, that dogma has stated that eating less saturated fat will lower the risk of heart disease and death.

Headlines quickly flashed the surprising findings: Thousands of people in the Prospective Urban Rural Epidemiology (PURE) study who ate more fat even saturated fat found in meat and cheese had a lower risk of death. And people who ate more carbohydrates had a higher death rate.

Immediately, the Twitterverse lit up with reasons why the new study is flawed:

"Does it have limitations? Of course, all studies do," said Richard Bazinet, associate professor at the University of Toronto. He wasn't involved in the research, but Bazinet said it's the latest in a series of studies that have complicated the dietary fat story.

"This is seven years of big studies coming in that don't fit," Bazinet said. "It's getting hard to say there's nothing to see here."

Bazinet is a nutrition scientist who studies the effect of dietary fat on the brain. He believes he's seeing a major shift in the dietary fat dogma that he was taught as a graduate student in the 1990s.

"I was trained in a field where this was taught to everybody. Saturated fats are bad. They raise your cholesterol. They raise your risk of heart disease. And now my honest opinion is that's at least oversimplified, if not wrong."

The dietary fat dogma started more than a century ago with some meat-eating rabbits.

Back in 1908, scientists noticed that rabbits who were fed high cholesterol diets (meat, eggs, milk) developed plaque in their arteries. It was the beginning of a diet-heart hypothesis that reached full flower in the 1950s, when researcher Ancel Keys convinced the world that diets high in saturated fat increased the risk of heart disease.

But gradually the scientific pendulum has started swinging in the other direction, as a series of studies and meta-analyses suggest the fat/carb diet/health equation is much more complicated.

In one dramatic twist to the whole fat story, two large randomized trials from the early '70s were never published. Later, when the data was recovered, it became clear why. Both studiesfailed to support the diet-heart hypothesis.

A few months ago, a group of British researchers dared to suggest that the dogma was dead. We reported on the dietary dust-up that followed in an April edition of Second Opinion.

"As nutritional scientists, we've been watching this develop for almost 10 years," Bazinet said."Maybe we're reworking the diet-heart hypothesis, maybe we're tweaking it, but something is going on."

It will take a well-designed randomized controlled trial to ultimately resolve the uncertainty about diet and health. In an accompanying commentary in The Lancet, one researcher had this advice: "Until then, the best medicine for the nutrition field is a healthy dose of humility."

What about the rest of us, raised on the dogma that fats are bad? That story hasn't changed.

"The recommendation from our study is moderation in both carbohydrate and fat intake," said PURE study author Mahshid Dehghan, from the Population Health Research Institute at McMaster University.

The human body needs a balance of fats, protein and carbohydrates to fuel its complex metabolic processes. So the basic nutritional advice remains the same: control calories, eat both fats and carbohydrates in moderation and aim for as much fresh food as possible.

An illustration of T cells attacking a cancer cell. (Shutterstock / Meletios)

An important milestone in cancer treatment was reached this week, when the U.S. Food and Drug Administration (FDA) officially approved the first of a new type of cell-based immunotherapy for use in patients with a form of childhood leukemia who have not responded to standard chemotherapy.

While the FDA approval was expected (see Second Opinion July 15), no one knew what it would cost. Before the announcement, analysts speculated about how high the price might go. Within hours, Novartis revealed the number: $475,000 US.

Right now, the therapy is only available in a few specially selected centres in the U.S. But a Canadian team is trying to come up with an affordable, made-in-Canada version that will be offered as part of the public health care system.

"It's really exciting that this has finally happened. It's a great step forward for cancer therapy," said John Bell, senior cancer researcher at the Ottawa Hospital Research Institute. "Part of what we're trying to do is explore the ways to provide this product to Canadians without having it commercially produced and see if that's a way to make it more affordable to Canadians."

The treatment is called chimeric antigen receptor T cell therapy (CAR-T), and it's complicated.

First, doctors extract a patient's white blood cells and infect the cells with a specially engineered virus that reprograms them to attack cancer. Then the cells are infused back into the patient's body. The therapy is risky because it can trigger a potentially fatal immune response. Patient deaths have interrupted clinical trials of competing therapies.

"This is a technology that in some patients appears to be curative even when they have advanced disease," Bell said. He is the scientific director of BioCanRX, a research network based at the Ottawa Hospital that is funding Canadian CAR-T projects."We hope to start a trial sometime in the next year or early the following year using this exact kind of strategy."

Canadian researchers are also studying CAR-T for use against solid cancer tumours. So far, the therapy has only been shown to work on acute lymphoblastic leukemia (ALL) and other blood cancers.

(Shutterstock / st.noon)

The U.S. FDA also made headlines this week after cracking down on clinics offering untested stem cell therapy.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine," FDA Commissioner Scott Gottlieb said in a new release announcing measures to increase enforcement. "We have examples where some of these unproven treatments have clearly harmed patients."

The FDA sent a warning letter to one Florida clinic that removes stem cells from fat tissue and re-injects them into the spinal cords of patients suffering from Parkinson's disease, heart disease and other serious conditions.

In a second action, U.S. marshals seized vials of a live vaccinia virus vaccine from a California clinic. The vaccine is not commercially available and it is reserved for people at high risk of smallpox exposure. The clinic was using the vaccine as part of what the FDA called a "potentially dangerous" cancer treatment, mixing it with stem cells and injecting it directly into patients' cancer tumours.

Bioethics researcher Leigh Turner has studied the proliferation of direct-to-consumer stem cell clinics.

"It's an important message that the FDA plans to engage in increased enforcement activity in the direct-to-consumer stem cell space," said Turner, who is an associate professor at the University of Minnesota. But he is concerned that the FDA is understating the problem by saying that there are only a small number of "bad actors."

"That's a misrepresentation of the current state of the direct-to-consumer stem cell market in the United States."

Turner has analyzed the consumer stem cell market and established a database.

"We found 351 distinct businesses in the United States making marketing claims about stem cell treatments operating a total of 570 clinics. And I've been following the marketplace since then and I can say the numbers are climbing at a rapid rate."

Turner has also studied the Canadian stem cell marketplace.

"What has emerged are a number of businesses in Canada marketing stem cell treatments for orthopedic indications," he said.

In an email, Health Canada saidit has only granted market authorization for one stem cell therapy to treat complications from bone marrow transplants in children.

"Found a deceptive food label? We want to hear from you." The Canadian Food Inspection Agency sent that tweet in mid-August as a reminder to Canadians to be on the lookout out for food fraud. Is it really made in Canada? Are there hidden allergens? Those are a few violations that Canadians can report.

"It can be a wide range," said Aline Dimitri, the CFIA's deputy chief food safety officer. "In some cases they can say that weight that's on it, I don't think I'm getting as much as I thought I was getting because net weight is also part of the labelling-related issues we look for at CFIA."

Food labelling regulations are a shared jurisdiction between Health Canada and the Canadian Food Inspection Agency. "Health Canada sets the standards and requirements for health and safety when it comes to food," Dimitri said. "We are the enforcement and inspection arm."

Is there too much water, or added sugar in maple syrup or honey? "There are certain products for which we have a standard. We know what sugar has to be there, what's the water content," Dimitri said. "And we know in these cases it can be mislabelled."

But what about misleading nutritional claims? That's the question Dr. Yoni Freedhoff had after he saw the CFIA tweet.

Freedhoff is an Ottawa obesity expert who also writes a food watch blog. After he saw the CFIA tweet, he went shopping and posted a series of food labels that he described as deceptive. But if he had complained to the CFIA, nothing would have happened.

"Nothing would have happened because they're not breaking any laws," he said. But he believes Health Canada should be concerned about some of the ways food processors imply their products are healthy.

Freedhoff says certain words have health inferences without making any overt claims.

"If you put vitamin D and whole grains on the front of your package, it's a health claim without being an explicit health claim."

"You see these health claims or health inferences on products that contain a large amount of sugar," he said. "The issue is that ultra-processed foods appear to be problematic to health."

"The harder a package tries to convince you that its contents are healthful, the more skeptical perhaps you should be."

New front-of-label packaging regulations are being considered for foods high in salt, sugar and saturated fat. A Health Canada spokesperson said more consultations on those label changes are planned for this fall.

As part of our summer Second Opinion series, we're featuring great Canadian moments in medical history. This week,meetBrenda Milner, one of the world's leading neuroscientists, who discovered how the brain remembers.

Canadian neuroscientist Brenda Milner discovered how the brain remembers.

When Milner began her research in the 1950s, the human brain was mysterious, uncharted territory.

Working at the Montreal Neurological Institute with famous Canadian neurosurgeon Dr. Wilder Penfield, Milner studied patients after Penfield operated on their brains to remove lesions or treat epilepsy.

Through that work, Milner systematically established that particular regions of the brain are associated with specific functions. It was foundational research in the emerging field of cognitive neuroscience.

"She's probably most well known for essentially discovering that the hippocampus, a structure deep in the temporal lobe of the brain, is responsible for the formation of memories," said Robert Zatorre, a neuroscientist at the Montreal Neurological Institute who worked in Milner's lab in the '80s.

Her most famous work involved a patient known as H.M., who had his entire hippocampus removed, leaving him unable to form any memories. Milner discovered that even though H.M. failed to remember even meeting her, he was still able to improve his performance on specific tests, without recalling ever learning them. Those experiments proved that there are different memory systems in the brain.

"This is now in every psychology textbook," said Zatorre. "If you take an intro psych course anywhere in the world they will tell you the difference between episodic memory and proceduralmemory. That was a discovery she made back in the 1970s. She followed this up with lots of work in other domains."

Dr. Milner was born in 1918. At age 99, she is still on faculty at the Montreal Neurological Institute.

These fascinating stories of discovery were selected from the Canadian Medical Hall of Fame, a medical history organization that began in 1994. Every year, six Canadians are inducted. There is a small exhibit hall in London, Ont., but executive director Lissa Foster told us the real hall lives online, with video features for the 125 laureates.

Thanks for reading! You can email us any time with your thoughts or ideas. And if you like what you read, consider forwarding this to a friend.

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FDA announces actions regarding stem cell treatments – Lexology – Lexology (registration)

September 2nd, 2017 9:43 pm

Together with new guidance regarding the potential regulatory pathways for gene therapies, the FDA announced on Monday, August 28, 2017, that it will be taking action against companies providing unapproved stem cell treatments. This new guidance, combined with the threat of enforcement actions, provides the regenerative medicine industry and its partners with certain direction regarding the differences between pioneering stem cell therapies for which regulatory pathways are being crafted and unapproved treatments, which are likely to trigger scrutiny by the FDA.

Overview of enforcement actions

On August 24, the FDA issued a warning letter to a Florida clinic that recovered a patient's own adipose tissues, processed those tissues into stromal vascular fraction (SVF) i.e., adult stem cells derived from the patient's own fat and then administered the SVF to the patient for treatment of any one of several conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS) and chronic obstructive pulmonary disease (COPD).

The FDA rejected the clinic's arguments that

Instead, the FDA took the position that the post-recovery processing of the adipose tissues takes the procedure outside of both the definition of an HCT/P and the same-surgical-procedure exception. The agency further noted that use of SVF for conditions such as Parkinson's disease, ALS and COPD do not meet the homologous use requirement of 21 CFR 1271.10. The agency also announced an action against a separate stem cell therapy clinic in California.

In light of these developments, practitioners and clinics who are

Guidance for regenerative medicine companies

While announcing these regulatory and enforcement actions, the FDA also sought to reassure the regenerative medicine industry of the agency's dedication to promoting this field of science. FDA Commissioner Scott Gottlieb wrote that the agency plans to "advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field." Manifesting the agency's willingness to work with industry, Dr. Gottlieb noted that while "[m]any of the individualized treatments fall clearly outside the FDA's pre-market requirements[f]or those that currently fall across the line and are subject to the FDA's existing pre-market review, we want to make sure the process for gaining FDA approval is efficient. We want to facilitate innovation." Thus, while signaling its intent to take action against entities it believes are "targeting vulnerable patients," the FDA indicated that it "will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path towards approval."

The FDA also reaffirmed its commitment to fully implementing the regenerative medicine advanced therapy (RMAT) designation process. The designation is given to cell therapies, therapeutic tissue engineering products, human cell and tissue products, or any combination product using such therapies or products intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. See Section 3033 of the 21st Century Cures Act.

These are important developments for stakeholders across the regenerative medicine industry, including:

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FDA announces actions regarding stem cell treatments - Lexology - Lexology (registration)

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Chemicals found in everyday products could be making you fat: Study – Bel Marra Health

September 2nd, 2017 9:43 pm

Home Weight Management Obesity Chemicals found in everyday products could be making you fat: Study

In todays modern world, we are used to conveniences that seem luxurious to those living in third world countries. One such convenience is the availability of food that is literally at our finger tips. Unfortunately, we may be overlooking what that is doing to our health.

The high level of consumerism in the United States comes with the drive for competition to make as much money as possible. Food companies are always on the look out to cut cost and increase revenue, and sadly, this has come at the cost of our health.

The industrialization of the consumer marketplace has led to the use of chemicals designed to boost profits without proper testing on how it affects human health.

A new study carried out by Cedars-Sinai investigators suggest that the chemicals put in everyday products, often to help increase their shelf life, are making the population obese.

The researchers developed a novel platform and protocol for testing the effect of chemicals known to disrupt the human endocrine systemthe secretion of hormones and chemical substances that regulate the activity of cells and/or organs.

Three chemicals found in common everyday products were investigated:

Human grown tissue from human stem cells was used to demonstrate the effect these chemicals had over long-time exposure. It was found that the normal human chemical that let people know they are full was being interfered with, breaking it down and possibly leading people to continue to eat.

We discovered that each of these chemicals damaged hormones that communicate between the gut and the brain. When we tested the three together, the combined stress was more robust, said Dhruv Sareen, assistant professor of Biomedical Sciences and director of the Induced Pluripotent Stem Cell Core Facility at the Cedars-Sinai Board of Governors Regenerative Medicine Institute.

The research team reached this conclusion by obtaining blood samples from adults and then converted those cells into induced pluripotent stem cells by introducing reprogramming genes. This allowed the researchers to grow human gut and neuronal tissue, both of which play a role in regulating appetite and metabolism.

Then they exposed the chemicals mentioned one by one, and in various combinations. They found that the chemicals disrupted the chemical networks that prepare signaling hormones, making them ineffective. It was also observed that these chemicals damaged mitochondriacellular structures that drive the bodys metabolism.

The scary part is that the cellular damage sustained occurred in the early-stages of cells, suggesting that a defective hormone system could impact a pregnant mother as well as her fetus. Previous studies done in animal models even found that endocrine disruptors such as these can be passed down from generation to generation.

Living in this modern age, we are surrounded by hundreds of chemicals. While not all are bad, a few are thought to pose a significant risk to human health. Human testing is not good clinical practice and makes it harder to find out exactly what effect such chemicals would have.

The protocol developed to test chemicals on actual human tissue would potentially make the evaluation of harmful chemicals easier and even be cost effective, according to the researchers.

Related: Poor sleep could be making you fatter

Related Reading:

Smelling your food can make you fatter

Living in an unclean environment can make you fatter

https://www.nature.com/articles/s41467-017-00254-8

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Adult Stem Cell Therapy Abroad

September 2nd, 2017 9:42 pm

Stem Cells Pool Re-population

In order to self-repair, living organisms have stem cells in central and peripheral locations which can be attracted to sites of injured tissues by alarm signals. In this way, these cells proliferate, migrate, and accumulate in those damaged sites. If this situation of alarm perpetuates, stem cells could be permanently exhausted from their original locations leading to irreversible disease.

Basically, it could be a matter of stem cell quantity and effective availability at a certain time point when active regeneration is needed. adult stem cell therapy abroad The expected consequences of this situation could be the lack of an appropriate number of stem cells for further tissue replacement and regeneration and eventually the development of disease and ageing.

For example, we could think that any alteration of this stem cell homoeostasis by constant and repetitive trauma, physical hyperactivity, chronic inflammation and chronic disease could provoke a persistent disequilibrium inside all these reserve locations. This could promote an irreversible and premature stem cell exhaustion, being impossible then for the organism to self-repair and survive.

As we age we have less circulating stem cells. Introduction of new stem cells to our bodies circulation can improve health and repopulate our stem cell pool.

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Adult Stem Cell Therapy Abroad

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Human Stem Cells Fight Parkinson’s Disease in Monkeys – Scientific American

September 2nd, 2017 9:42 pm

LONDON (Reuters)Scientists have successfully used reprogrammed stem cells to restore functioning brain cells in monkeys, raising hopes the technique could be used in future to help patients with Parkinsons disease.

Since Parkinsons is caused by a lack of dopamine made by brain cells, researchers have long hoped to use stem cells to restore normal production of the neurotransmitter chemical.

Now, for the first time, Japanese researchers have shown that human induced pluripotent stem cells (iPS) can be administered safely and effectively to treat primates with symptoms of the debilitating disease.

So-called iPS cells are made by removing mature cells from an individualoften from the skinand reprogramming them to behave like embryonic stem cells. They can then be coaxed into dopamine-producing brain cells.

The scientists from Kyoto University, a world-leader in iPS technology, said their experiment indicated that this approach could potentially be used for the clinical treatment of human patients with Parkinsons.

In addition to boosting dopamine production, the tests showed improved movement in affected monkeys and no tumors in their brains for at least two years.

The human iPS cells used in the experiment worked whether they came from healthy individuals or Parkinsons disease patients, the Japanese team reported in the journal Nature on Wednesday.

This is extremely promising research demonstrating that a safe and highly effective cell therapy for Parkinsons can be produced in the lab, said Tilo Kunath of the MRC Centre for Regenerative Medicine, University of Edinburgh, who was not involved in the research.

The next step will be to test the treatment in a first-in-human clinical trial, which Jun Takahashi of Kyoto University told Reuters he hoped to start by the end of 2018.

Any widespread use of the new therapy is still many years away, but the research has significantly reduced previous uncertainties about iPS-derived cell grafts.

The fact that this research uses iPS cells rather human embryonic stem cells means the treatment would be acceptable in countries such as Ireland and much of Latin America, where embryonic cells are banned.

Excitement about the promise of stem cells has led to hundreds of medical centers springing up around the world claiming to be able to repair damaged tissue in conditions such as multiple sclerosis and Parkinsons.

While some treatments for cancer and skin grafts have been approved by regulators, many other potential therapies are only in early-stage development, prompting a warning last month by health experts about the dangers of stem-cell tourism.

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Human Stem Cells Fight Parkinson's Disease in Monkeys - Scientific American

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FDA cracks down on shady stem cell treatment clinics sweeping the US – New Atlas

September 2nd, 2017 9:42 pm

On Friday August 25th, US Marshals seized five vials of a smallpox vaccine from a stem cell treatment center in California. The action was undertaken on behalf of the FDA, which followed up the seizure with a larger announcement targeting the "unscrupulous clinics" selling unproven stem cell treatments that have rapidly arisen across the United States in recent years.

The unconventional smallpox "treatment" was being delivered by a company called StemImmune. The FDA alleges that the smallpox vaccine treatment was discovered after inspecting two California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. The vaccine was apparently being combined with adult stem cells derived from a patient's body fat and this combined product was then administered to a patient either intravenously or injected directly into the tumors.

Not only does this strange treatment have no clinical backing, but the FDA noted "serious concerns" as to how the company obtained this vaccine in the first place.

"The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work," says Scott Gottlieb, FDA Commissioner. "I especially won't allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse."

Dr. Mark Berman of the Cell Surgical Network, who works with the California Stem Cell Treatment Centers, fired back angrily at the FDA claiming Gottlieb's comments were "disparaging and misrepresentative."

The statement went on to claim that StemImmune's work involved, saying "many top national andinternational doctors and scientists are participating in this study, including our nation's ownDepartment of Defense."

A study was published in 2016 documenting the rapid rise of commercial stem cell treatment centers in the US. Paul Knoepfler and Leigh Turner's research paper was published in the journal, Cell Stem Cell, and it chronicled a startling 351 businesses marketing unapproved stem cell interventions across 570 clinics.

This frightening study revealed a burgeoning marketplace in the US, replacing the traditional trend of "medical tourism." Exploiting potential loopholes in the regulatory system, these clinics were offering unproven stem cell treatments for just about every disease you can think of.

"Brakes ought to exist in a marketplace like this, but where are the brakes? Where are the regulatory bodies?" says Leigh Turner, co-author of the study. "And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?"

These stem cell clinics seem to be operating inside a grey area whereby their treatments are not exactly classifiable under general FDA regulations. Many of these clinics simply extract stem cells from a patient's adipose tissue, subject those cells to minimal manipulation, and then implant them back into the same patient. This allows the procedure to be classified under a surgical procedure exemption meaning it doesn't need regulatory approval. Essentially it is not a "drug" or "medical" procedure, but instead just a straightforward "surgical" procedure.

The FDA has recently looked to address this loophole. Since 2015 the regulatory body has been working on reclassifying the way it views the repurposing of a patient's own tissue. Draft guidelines, not yet passed into law, are designed to classify these stem cell treatments as "drugs," meaning any treatment will need to undergo a stringent approval process.

Alongside the more dramatic smallpox incident, the FDA recently reset the battle lines with stem cell clinics. One company, called US Stem Cell Clinic (USSC), was delivered an expansive warning letter from the FDA arguing that the repurposing of adipose tissue in this context must be considered a drug.

The company responded by claiming the procedure is exempt from regulation, "because the procedures practiced at USSC do not involve more than 'minimal manipulation'." It seems the fundamental questions being argued here are how much manipulation of the tissue is actually taking place and for what is the claimed function of the resulting implantation?

The latest FDA announcement is drawing a line in the sand. Stem cell clinics delivering unproven treatments are on notice. It's yet to be seen actually how far the FDA will be able to go in legally moving on some of these clinics, but a new framework, set to clarify the regulatory processes surrounding these new treatments, will be delivered soon.

Source: FDA

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Coming Soon: Osher Mini Medical School Series on Personalized Medicine Powered by Precision Imaging – UCSF Department of Radiology & Biomedical…

September 2nd, 2017 9:41 pm

On Thursday evenings beginning Oct. 12, UCSF Imagings world-renowned radiologists will participate in the UCSF Osher Center for Integrative Medicines Mini Medical School for the Public in a six-week series titled Personalized Medicine Powered by Precision Imaging. This informative course is open to the public. Attendees will have the opportunity to meet experts from UCSF Imaging, who are using and developing new and innovative precision imaging tools to enhance diagnosis, improve disease monitoring, and optimize treatment for individual patients.

In close partnership with subspecialty physicians from other UCSF departments, radiologists are now able to use these tools to pinpoint and better treat disorders such as prostate cancer, breast cancer and degenerative spine and joint disease at earlier stages. This series of lectures will explain how emerging technologiesincluding specific artificial intelligence platformswill rely upon imaging to dramatically improve accuracy, safety, and outcomes for patients in the very near future.

This course is co-chaired by William P. Dillon, MD, and Christopher P. Hess, MD, PhD, and there will be 17 faculty members participating in the lectures. The schedule is as follows:

To register for the full course, please visit osherminimed.ucsf.edu. To register for a single class, call (415) 476-5808. Each class will be held in the School of Nursing, Room N225, at 513 Parnassus, accessible through the Medical Science Building.

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Tempus and University of California Davis Comprehensive Cancer … – GlobeNewswire (press release)

September 2nd, 2017 9:41 pm

CHICAGO, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Tempus, a technology company focused on helping doctors personalize cancer care by collecting and analyzing large volumes of molecular and clinical data and University of California Davis Comprehensive Cancer Center are collaborating on a precision medicine partnership to advance clinical care with Next Generation Sequencing analysis, focused initially on patients diagnosed with hematological malignancies and pancreatic cancer.

As part of the collaboration, Tempus will do molecular sequencing and analysis for a group of patients at UC Davis Comprehensive Cancer Center. Utilizing machine learning and advanced bioinformatics, Tempus helps physicians analyze data sets in a search for potentially relevant patterns that can help guide treatment for patients who are unlikely to respond to conventional therapies or for whom no conventional therapies exist.

Technology has come a long way since researchers first mapped the genome more than 15 years ago and yet physicians and their patients have not widely benefited, said Eric Lefkofsky, Founder and CEO at Tempus. We are excited to bring the Tempus platform to physicians at the UC Davis Comprehensive Cancer Center who will now have access to technology and analytics that will support their efforts to deliver personalized treatment for each patient.

Tempus will work with a team of investigators led by Dr. Primo Lara, an esteemed investigator in clinical-translational research, who has chaired a number of cancer clinical trials from phase I to III.

Discovery is happening at a rapid pace and will continue to accelerate with access to data-driven tools designed to support work in the clinic, said Dr. Lara, Interim Director of the UC Davis Comprehensive Cancer Center. Working with Tempus is consistent with our commitment to providing our physicians with the tools and resources they need to best treat their patients.

The UC Davis Comprehensive Cancer Center is among the top-ranked national cancer programs for both research and patient care. It is one of 48 centers designated "comprehensive" by the National Cancer Institute.

About Tempus: Tempus is a technology company that is building the worlds largest library of molecular and clinical data and an operating system to make that data accessible and useful. We enable physicians to deliver personalized cancer care for patients through our interactive analytical and machine learning platform. We provide genomic sequencing services and analyze molecular and therapeutic data to empower physicians to make real-time, data-driven decisions. Our goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as we gather more data. For more information, visit tempus.com and follow us on Facebook (Tempus Labs) and Twitter (@TempusLabs).

About UC Davis Comprehensive Cancer CenterUC Davis Comprehensive Cancer Center is the only National Cancer Institute-designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its specialists provide compassionate, comprehensive care for more than 10,000 adults and children every year, and access to more than 125 clinical trials at any given time. Its innovative research program engages more than 280 scientists at UC Davis, Lawrence Livermore National Laboratory and Jackson Laboratory (JAX West), whose scientific partnerships advance discovery of new tools to diagnose and treat cancer. Through the Cancer Care Network, UC Davis collaborates with hospitals and clinical centers throughout the Central Valley and Northern California to offer the latest cancer-care services to their communities. UC Davis community-based outreach and education programs address disparities in cancer outcomes across diverse populations. For more information, visit http://cancer.ucdavis.edu.

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Tempus and University of California Davis Comprehensive Cancer ... - GlobeNewswire (press release)

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Illumina: DNA Sequencing Leader is Gaining Momentum – Markets Morning

September 2nd, 2017 9:41 pm

It is the medical sensation of the year: Researchers have succeeded in selectively altering the human genome with the genetic scissors CRISPR. Using this controversial tool, the scientists have remedied gene defects that are responsible for a heart defect in human embryos. In order to find the defective parts in the genome, the genome (the entire genotype of a human being) must be sequenced ahead of time, i.e. decoded. Technological leadership in this area is the US diagnostics specialist Illumina.

In addition to genetic scissors, personalized medicine is currently one of the dominant and hotly debated subjects in medicine. Because the trends that each patient receives a personalized therapy, that is to say, tailored to the individual. The selection of the drugs as alone or combined treatment as well as the subsequent medication in the future depend on which genes are modified or mutated.

And since Illumina comes into play: The Group of San Diego has succeeded in recent years in the area of diagnostics unique product portfolio. Above all, the latest product line called NovaSeq promises an incomparable cost-benefit effect.

These Illumina products are able to decipher a human genome up to 70 percent faster. At the same time, the costs for the process are rapidly reduced. The biotech company has set itself the goal of pushing the financial expenditure for the decoding of a genome to only 100 dollars.

The highlight: On the one hand, the NovaSeq sequencing technology contributes to the cost reduction in the respective health system, de facto entirely according to the taste of Donald Trump. On the other hand, this technological advancement is the key to personalized medicine and allows the targeted use of the genetic scissors CRISPR.

The biotech company is proposing several things together: While the costs of genome analysis fall by another 90 percent, Illuminas profit goes through the ceiling. In the coming year, the diagnostics specialist is likely to implement more than three billion dollars for the first time and benefit more than ever from the medical megatrends. The quarterly figures for the second quarter in this fiscal year have already impressively delivered a taste for what this technological advance will bring.

Illumina is back on track and was able to significantly exceed analysts expectations. In addition to a pleasing result of $0.82 per share, investors were above all convinced by the sales of 662 million dollars. Illumina was able to overcome the growth rate of the past quarters. At the same time, the biotech forge raised the outlook for the current financial year. The fact that the business is gaining momentum is mainly due to the NovaSeq series, which has been on the market since April.

Whether genetic scissors, personalized medicine or artificial intelligence in diagnostics: the basis for the breakthrough or successful use of these trends is genome analysis. Due to the market power and the technological know-how, there is no way around the Illumina biotech weakening.

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British Lung Foundation Funds 3 Research Projects on Personalized Medicine for IPF, Other Lung Diseases – Pulmonary Fibrosis News

September 2nd, 2017 9:41 pm

The British Lung Foundation (BLF), in collaboration with GlaxoSmithKline (GSK) has awarded 1.3 million (about $1.68 million) in grants to three lung disease experts to support research projects on finding new therapeutic targets for personalized medicine inidiopathic pulmonary fibrosis (IPF),bronchiectasis andchronic obstructive pulmonary disease (COPD).

Our professorships nurture and develop outstanding lung researchers who can bring groundbreaking research and international leadership to lung disease, Ian Jarrold, the BLFs head of research, said in a press release.We witness first-hand the devastating consequences that the long-term neglect of lung disease can have on patients and their families. Considering the impact diseases like bronchiectasis, COPD and IPF have on a patients quality of life, the lack of support and treatment options available is wholly unacceptable.

One of the three recipients is Toby Maher, clinical investigator at the National Heart and Lung Institute (NHLI), Imperial College London, and consultant respiratory physician at Royal Brompton Hospitals Interstitial Lung Disease Unit.

Maher and his team are studyingthe underlying mechanism that causes the tissue scaring that leads to IPF. He is also identifying groups of patients who may respond well topersonalized treatments.

Given the poor prognosis of IPF patients, they dont have time to wait years for new treatments, Maher said. I will be identifying blood-based biomarkers which could halve the time taken to validate new medicines, and running clinical trials with a focus on repurposing existing drugs to further cut the time taken to make novel treatments available to individuals with IPF.

He added: As many as 1 in 10 individuals with IPF also develop episodes of acute exacerbation or infection each year, with these episodes leading to 50 percent of people dying within a month. I aim to reduce this through a home monitoring project empowering patients to spot early deterioration in their disease.

Professor Louise Wain of theUniversity of Leicesterandprofessor James Chalmers of the University of Dundeeboth received GSK/BLF Chair in Respiratory Research awards for their contributions inunderstanding lung diseases.

Wains research project will integrate genetic analysis with clinical data to identify genetic susceptibility markers for IPF and COPD. Chalmers project aims toidentify patients that could benefit from personalized therapies, and based on this knowledge develop potential tests to detectinfection or inflammation processes that may respond to personalized treatment.

Work by all three grant recipients has the potential to improve our understanding of these diseases, and provide personalized medicine, something which has already led to huge improvements in the treatment of many cancers, Jarrold said. He added that their work will provide families dealing with a lung disease diagnosis more hope for the future.

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In a precision medicine landmark, FDA approves first gene therapy – Healthcare IT News

September 2nd, 2017 9:41 pm

Calling the move "historic," the Food and Drug Administration announced approval August 30 for the first gene therapy in the U.S.

Its a gene therapy that hospital CIOs and IT shops, particularly those working on precision medicine initiatives, would be smart to watch since experts are already saying it is a fundamental turning point that holds promise to transform the practice of medicine.

Heres what healthcare executives and technologists should know.

Kymriah, the brand name under which Norvatis is marketing the drug tisagenlecleucel, offers a new treatment option that will first be explored for use in cases of acute lymphoblastic leukemia in kids and young adults.

The treatment, a genetically-modified autologous T-cell immunotherapy, was approved by FDA for use in patients aged 25 or younger who demonstrate certain characteristics of cancer.

Doses of Kymriah are customized using an individual patient's own T-cells, which are genetically modified to include a new gene that has a specific protein known as a chimeric antigen receptor, or CAR that directs the T-cells to target and kill leukemia cells that have a specific antigen (called CD19) on the surface.

FDA says the safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," said FDA Commissioner Scott Gottlieb, MD. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses."

But the immunotherapy carries a big risk for potentially life-threatening side effects, according to FDA. It could cause cytokine release syndrome, a systemic response to the proliferation of CAR T-cells causing high fever and flu-like symptoms, as well as certain dangerous neurological symptoms.

It's also expensive, at roughly $475,000. That's in addition to traditional chemotherapy, which is administered before the Kymriah with the aim of improving the treatment's success rate.

And because the side effects are potentially so serious, patients will be required to stay within two hours of the 32 hospitals where the immunotherapy is administered, for as long as a month after treatment leading to hefty travel and lodging costs.

Beyond the financial implications, of course, there are significant IT hurdles to overcome, going forward, for widespread and efficient use of personalized medicine.

From data warehousing to EHR design to interoperability, ongoing technology challenges will test IT departments as immunotherapy and other tailored treatments come to the fore.

The research on Kymriah was pioneered at Penn Medicine, for instance, but not before the academic medical center had pursued an extensive retooling of its infrastructure to meet the demands of precision medicine.

"One of the first things we did was to say, look, we're not going to get down this road to precision medicine if we don't have centralized support and a holistic view of IT within the school," Brian Wells, Penn Medicine's then associate vice president of health technology and academic computing, said ahead of the HIMSS and Healthcare IT News Precision Medicine Summit in June of 2017. "The other thing we did was ask, what are the high-priority applications that the school didn't have?

Penn didn't have a common laboratory information management system, for instance, or a common sample management, sample inventory, sample tracking system. Wells said Penn also needed a data warehouse to aggregate all the required information and link it to clinical data so researchers could access it more easily.

Despite the challenges inherent in such a novel treatment, researchers and FDA officials said the promise of this new cellular therapy is very real.

Peter Marks, MD, directory of the FDAs Center for Biologics Evaluation and Research, described Kymirah as a first-of-its-kind treatment for serious disease.

"Not only does Kymriah provide these patients with a new treatment option where very limited options existed, Marks said, but a treatment option that has shown promising remission and survival rates in clinical trials."

And one that IT departments are likely to support in the not-too-distant future.

Twitter:@MikeMiliardHITNEmail the writer: mike.miliard@himssmedia.com

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Brand name for albuterol inhaler – Albuterol sulfate long term side effects – Magnetic Media (press release)

September 2nd, 2017 9:41 pm
Brand name for albuterol inhaler - Albuterol sulfate long term side effects
Magnetic Media (press release)
Albuterol inhaler dose sensations an precise occurred S from but medicine for similar problems. ever price here March group surgery series Era no healthcare to Endo zobowiazanie in on constant continued new no your be blood everyday hour (the pieces ...

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Brand name for albuterol inhaler - Albuterol sulfate long term side effects - Magnetic Media (press release)

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Critical Analysis: PTC Therapeutics (PTCT) & Keryx Biopharmaceuticals (KERX) – Dispatch Tribunal

September 2nd, 2017 9:40 pm

PTC Therapeutics (NASDAQ: PTCT) and Keryx Biopharmaceuticals (NASDAQ:KERX) are both small-cap medical companies, but which is the better investment? We will contrast the two businesses based on the strength of their profitability, analyst recommendations, earnings, institutional ownership, dividends, valuation and risk.

Institutional and Insider Ownership

81.4% of PTC Therapeutics shares are held by institutional investors. Comparatively, 65.2% of Keryx Biopharmaceuticals shares are held by institutional investors. 8.1% of PTC Therapeutics shares are held by insiders. Comparatively, 3.1% of Keryx Biopharmaceuticals shares are held by insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a company will outperform the market over the long term.

Volatility & Risk

PTC Therapeutics has a beta of 1.39, indicating that its stock price is 39% more volatile than the S&P 500. Comparatively, Keryx Biopharmaceuticals has a beta of 5.23, indicating that its stock price is 423% more volatile than the S&P 500.

Analyst Recommendations

This is a summary of recent recommendations for PTC Therapeutics and Keryx Biopharmaceuticals, as provided by MarketBeat.com.

PTC Therapeutics currently has a consensus target price of $15.44, suggesting a potential downside of 26.21%. Keryx Biopharmaceuticals has a consensus target price of $7.50, suggesting a potential downside of 1.32%. Given Keryx Biopharmaceuticals stronger consensus rating and higher probable upside, analysts clearly believe Keryx Biopharmaceuticals is more favorable than PTC Therapeutics.

Profitability

This table compares PTC Therapeutics and Keryx Biopharmaceuticals net margins, return on equity and return on assets.

Earnings & Valuation

This table compares PTC Therapeutics and Keryx Biopharmaceuticals top-line revenue, earnings per share and valuation.

PTC Therapeutics has higher revenue and earnings than Keryx Biopharmaceuticals. PTC Therapeutics is trading at a lower price-to-earnings ratio than Keryx Biopharmaceuticals, indicating that it is currently the more affordable of the two stocks.

Summary

PTC Therapeutics beats Keryx Biopharmaceuticals on 7 of the 12 factors compared between the two stocks.

About PTC Therapeutics

PTC Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the discovery, development and commercialization of medicines using its expertise in ribonucleic acid (RNA) biology. Its product pipeline includes Ataluren (Translarna), PTC596 and RG7916. Its product candidate, ataluren, is an orally administered small-molecule compound for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of Duchenne muscular dystrophy caused by a nonsense mutation (nmDMD) and cystic fibrosis caused by a nonsense mutation (nmCF). PTC596 is an orally active small molecule that targets tumor stem cell populations by reducing the function, activity and amount of BMI1. RG7916 is an investigational oral therapeutic, which is in two clinical studies: SUNFISH, a trial in childhood onset (Type II/III) spinal muscular atrophy (SMA) patients, and FIREFISH, a trial in infant onset (Type I) SMA patients.

About Keryx Biopharmaceuticals

Keryx Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of medicines for people with renal disease. The Company is engaged in the manufacture, development and commercialization of products for use in treating human diseases. Its marketed product, Auryxia (ferric citrate), which is an orally available, absorbable, iron-based medicine is approved in the United States for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Auryxia is marketed in Japan under the brand name Riona. It is investigating the use of ferric citrate for the treatment of iron deficiency anemia (IDA) in adults with non-dialysis dependent (NDD), CKD and NDD-CKD. It focuses on Keryx Patient Plus program to assist with patient accessibility to Auryxia. It has completed a Phase II clinical trial and a Phase III clinical trial of ferric citrate to gain Food and Drug Administration approval to use ferric citrate in patients with NDD-CKD.

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Critical Analysis: PTC Therapeutics (PTCT) & Keryx Biopharmaceuticals (KERX) - Dispatch Tribunal

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