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China confirms third birth of gene-edited baby; scientists involved get prison terms – WRAL Tech Wire

Posted: January 5, 2020 at 4:27 am

A Chinese scientist who set off an ethical debate with claims that he had made the worlds first genetically edited babies three, according to a Chinese court was sentenced to three years in prison because of his research, state media, the Associated Press and the New York Times have reported.

He Jiankui, who was convicted of practicing medicine without a license, was also fined 3 million yuan ($430,000) by a court in the southern city of Shenzhen, Chinas official Xinhua News Agency reported on Monday. Two other researchers involved in the project received lesser sentences and fines.

The verdict said the three defendants had not obtained qualification as doctors, pursued fame and profits, deliberately violated Chinese regulations on scientific research, and crossed an ethical line in both scientific research and medicine, according to Xinhua. It also said they had fabricated ethical review documents.

The court also confirmed a third birth, saying the researchers were involved in the births of three gene-edited babies to two women. It said all three scientists pleaded guilty during the trial, which Xinhua reported was closed to the public because of privacy concerns.

Hes declaration made him a pariah among scientists, cast a harsh light on Chinas scientific ambitions and embroiled other U.S. scientists who were connected to He. Although He offered no proof and did not share any evidence or data that definitively proved he had done it, his colleagues had said it was possible that he had succeeded, The New York Times reported.

U.S. scientists who knew of Hes plans came under scrutiny. Hes former academic adviser, Stephen Quake, a star Stanford University bioengineer and inventor, was cleared of any wrongdoing after an investigation into his interaction with his former student. Rice University has been investigating Michael Deem, Hes doctoral adviser, because of allegations that he was actively involved in the project.

Duke engineers improve CRISPR genome editing with biomedical tails

He, the lead researcher, shocked the scientific world when he announced in November 2018 that he had altered the embryos of twin girls who had been born the same month. He described his work in exclusive interviews with The Associated Press.

The announcement sparked a global debate over the ethics of gene editing. He said he had used a tool called CRISPR to try to disable a gene that allows the AIDS virus to enter a cell, in a bid to give the girls the ability to resist the infection. The identity of the children has not been released, and it isnt clear if the experiment succeeded.

The CRISPR tool has been tested elsewhere in adults to treat diseases, but many in the scientific community denounced Hes work as medically unnecessary and unethical, because any genetic changes could be passed down to future generations. The U.S. forbids editing embryos except for lab research.

He, who is known as JK, told the AP in 2018 that he felt a strong responsibility to make an example, and that society would decide whether to allow the practice to go forward. He disappeared from public view shortly after he announced his research at a conference in Hong Kong 13 months ago, apparently detained by authorities, initially in an apartment in Shenzhen, a city in Guangdong province that borders Hong Kong.

It wasnt clear if the three-year prison term includes any of the time he has already spent in Chinese custody.

A Chinese scientist said the sentence should have been harsher to deter others. Kehkooi Kee, a Tsinghua University researcher who conducts gene-editing research on stem cells, also said that He should be held responsible for any fallout from the experiment on the lives of the babies and their families.

Dr. William Hurlbut, a Stanford University bioethicist whose advice He sought for more than a year before his experiment, said he felt sorry for the scientist, his wife and two young daughters.

I warned him things could end this way, but it was just too late, Hurlbut wrote in an email addressed to the AP; the director of the U.S. National Institutes of Health, Dr. Francis Collins; and gene-editing pioneer Jennifer Doudna at the University of California, Berkeley.

Sad story everyone lost in this (JK, his family, his colleagues, and his country), but the one gain is that the world is awakened to the seriousness of our advancing genetic technologies, Hurlbut wrote.

Dr. Eric Topol, who heads the Scripps Research Translational Institute in California, noted its almost unheard of for a scientist to get imprisoned but in this case the sheer recklessness and unethical behavior warranted it. Topol praised China for standing up for proper medical research conduct.

Doudna told the AP she was concerned about the mysterious legal process in China, but she said the sentences are a step toward bringing this case to closure and send a strong message to discourage other such work. (Doudna is paid by the Howard Hughes Medical Institute, which also supports APs Health and Science Department.)

As a scientist, one does not like to see scientists going to jail, but this was an unusual case, Doudna said. Hes work was clearly wrong in many ways.

Before setting up a lab at the Southern University of Science and Technology of China in Shenzhen, He studied in the U.S. The verdict accused him of colluding with Zhang Renli and Qin Jinzhou, who worked at medical institutes in the same province.

Zhang was sentenced to two years in prison and fined 1 million yuan, Xinhua said. Qin received an 18-month prison sentence, but with a two-year reprieve, and a 500,000 yuan fine.

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Duke researchers land $6M in federal grants to advance gene editing – WRAL Tech Wire

Posted: January 5, 2020 at 4:26 am

DURHAM Hemophilia. Cystic fibrosis. Duchenne muscular dystrophy. Huntingtons disease. These are just a few of the thousands of disorders caused by mutations in the bodys DNA. Treating the root causes of these debilitating diseases has become possible only recently, thanks to the development of genome editing tools such as CRISPR, which can change DNA sequences in cells and tissues to correct fundamental errors at the source but significant hurdles must be overcome before genome-editing treatments are ready for use in humans.

Enter the National Institutes of Health Common FundsSomatic Cell Genome Editing (SCGE)program, established in 2018 to help researchers develop and assess accurate, safe and effective genome editing therapies for use in the cells and tissues of the body (aka somatic cells) that are affected by each of these diseases.

Todaywith three ongoing grants totaling more than $6 million in research fundingDuke University is tied with Yale University, UC Berkeley and UC Davis for the most projects supported by the NIH SCGE Program.

In the 2019 SCGE awards cycle, Charles Gersbach, the Rooney Family Associate Professor of Biomedical Engineering, and collaborators across Duke and North Carolina State University received two grants: the first will allow them to study how CRISPR genome editing affects engineered human muscle tissues, while the second project will develop new CRISPR tools to turn genes on and off rather than permanently alter the targeted DNA sequence. This work builds on a 2018 SCGE grant, led by Aravind Asokan, professor and director of gene therapy in the Department of Surgery, which focuses on using adeno-associated viruses to deliver gene editing tools to neuromuscular tissue.

Duke engineers improve CRISPR genome editing with biomedical tails

There is an amazing team of engineers, scientists and clinicians at Duke and the broader Research Triangle coalescing around the challenges of studying and manipulating the human genome to treat diseasefrom delivery to modeling to building new tools, said Gersbach, who with his colleagues recently launched the Duke Center for Advanced Genomic Technologies (CAGT), a collaboration of the Pratt School of Engineering, Trinity College of Arts and Sciences, and School of Medicine. Were very excited to be at the center of those efforts and greatly appreciate the support of the NIH SCGE Program to realize this vision.

For their first grant, Gersbach will collaborate with fellow Duke biomedical engineering faculty Nenad Bursac and George Truskey to monitor how genome editing affects engineered human muscle tissue. Through their new project, the team will use human pluripotent stem cells to make human muscle tissues in the lab, specifically skeletal and cardiac muscle, which are often affected by genetic diseases. These systems will then serve as a more accurate model for monitoring the health of human tissues, on-target and off-target genome modifications, tissue regeneration, and possible immune responses during CRISPR-mediated genome editing.

Duke researchers: Single CRISPR treatment provides long-term benefits in mice

Currently, most genetic testing occurs using animal models, but those dont always accurately replicate the human response to therapy, says Truskey, the Goodson Professor of Biomedical Engineering.

Bursac adds, We have a long history of engineering human cardiac and skeletal muscle tissues with the right cell types and physiology to model the response to gene editing systems like CRISPR. With these platforms, we hope to help predict how muscle will respond in a human trial.

Gersbach will work with Tim Reddy, a Duke associate professor of biostatistics and bioinformatics, and Rodolphe Barrangou, the Todd R. Klaenhammer Distinguished Professor in Probiotics Research at North Carolina State University, on the second grant. According to Gersbach, this has the potential to extend the impact of genome editing technologies to a greater diversity of diseases, as many common diseases, such as neurodegenerative and autoimmune conditions, result from too much or too little of certain genes rather than a single genetic mutation. This work builds on previous collaborations between Gersbach, Barrangou and Reddy developing bothnew CRISPR systems for gene regulationandto regulate the epigenome rather than permanently delete DNA sequences.

Aravind Asokan leads Dukes initial SCGE grant, which explores the the evolution of next generation of adeno-associated viruses (AAVs), which have emerged as a safe and effective system to deliver gene therapies to targeted cells, especially those involved in neuromuscular diseases like spinal muscular atrophy, Duchenne muscular dystrophy and other myopathies. However, delivery of genome editing tools to the stem cells of neuromuscular tissue is particularly challenging. This collaboration between Asokan and Gersbach builds on their previous work in usingAAV and CRISPR to treat animal models of DMD.

We aim to correct mutations not just in the mature muscle cells, but also in the muscle stem cells that regenerate skeletal muscle tissue, explainsAsokan. This approach is critical to ensuring long-term stability of genome editing in muscle and ultimately we hope to establish a paradigm where our cross-cutting viral evolution approach can enable efficient editing in multiple organ systems.

Click through to learn more about theDuke Center for Advanced Genomic Technologies.

(C) Duke University

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TEDCO funds open again for applications – Maryland Daily Record

Posted: January 5, 2020 at 4:26 am

Four Maryland Technology Development Corporation funds will begin accepting applications for investments again after they had delayed investments while adapting regulations to an oversight law passed by the Maryland General Assembly last year.

The Builder Fund, the Maryland Venture Fund, the Rural Business Innovation Initiative and the Seed Fund are now accepting applications for investment.

Stephen Auvil (File photo)

We are thrilled to bring these application portals live after the team has worked hard to finalize the regulations, Stephen Auvil, TEDCOs executive vice president, said in a statement. Its our goal to get back to what TEDCO does best, and thats building great, Maryland-based startups and continuing to grow innovation and entrepreneurship in the state.

A legislative audit issued last February found issues that included how TEDCO directed funding to companies that were not primarily based in Maryland and invested in companies that had associations with the Maryland Venture Funds advisory committee.

In the aftermath of the audit, lawmakers put more restrictions in place to govern how TEDCO invests its money and what oversights are in place to govern the agency.

One of the lawmakers requirements was that TEDCO develop an application process for its investment programs. That application process is now ready, TEDCO said Friday.

The Builder Fund is designed to help startups founded by people from economically disadvantaged background. The Rural Business Innovation Initiative invests in companies from rural Maryland. The Maryland Venture Fund is a venture capital fund focused on growth stage companies, and the Seed Fund invests in seed-stage companies.

TEDCO explained to lawmakers last month how it had crafted its regulations to comply with the oversight law.

The new regulations more clearly define what a Maryland business is and how it can qualify for investments. They also define how a company not defined as a Maryland business can receive investment if it will have a substantial economic impact on the state.

Under the new regulations, state businesses must have their principal base of operations in Maryland; have more than half of their workforce in Maryland; and intend to maintain their base of operations in Maryland.

TEDCO also has created provisions that would allow it to claw back its investment if a company leaves the state.

While TEDCO is accepting applications now, investments could still take a little while to happen. The agencys Maryland Venture Fund Authority does not yet have a quorum of members appointed to disburse funds.

The Maryland Venture Fund will also only be accepting applications from current Maryland Venture Fund portfolio companies. It anticipates accepting applications from other companies for the fund later this spring.

TEDCO operates eight funds. Programs like the Maryland Innovation Initiative, which helps commercialize university technology, and the Maryland Stem Cell Research Fund were not affected by the new regulations.

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3D-printed Organs Give Hope to Transplant Patients Now. Powered by – Now. Powered by Northrop Grumman.

Posted: January 5, 2020 at 4:26 am

The 3D printer has won the hearts of manufacturers for its ability to create detailed products without the need for expensive and time-consuming prototyping. Everything from prosthetics to engines to football cleats have spun out of the technology.

But it couldnt create human organs, could it? Well, yes, it can. Scientists claim to have recently enhanced the performance and stability of 3D-printed organs, including a heart a development that would excite the Tin Man of The Wizard of Oz.

The real-life implications of organs created by 3D printing are vast and revolutionary. The printer could quickly produce organs to those in need of a transplant, and it could enhance the skills of surgeons by letting them practice on copied organs innovations many would say are worth copying on a large scale.

To be clear, the organs arent entirely the products of additive manufacturing, the term to describe 3D printing, but a recent development with the technology signals it will probably have a large role in advancing copied organs.

Creating organs through additive manufacturing had until now been largely unsuccessful. As described by Cosmos, laboratories have grown so-called organoids for the past decade. These miniaturized versions of the brain, heart and kidney help scientists study cancer, dementia and heart attacks. But with the models unable to expand beyond the size of a lentil, they couldnt incorporate the tubes that mimic blood vessels. Without those tubes, oxygen and nutrients struggle to reach the core of the organ.

It seemed as if the dream to produce ready-made full-sized organs in a lab would have to remain just that, a dream. But a recent breakthrough that combines human stem cells with a 3D-printed vascular channel could overcome the structural issues.

A new method of replication solves the size challenge by integrating 3D-printed vascular channels into living matrices of stem cells that form organ building blocks, according to the scientists who devised the technique SWIFT (sacrificial writing into functional tissue). The 3D printer infuses ink and gelatin into a matrix and the mix is then heated, melting the ink and leaving a channel that is then lined with cells found in human vessels. Stir in oxygen and nutrients and you have an organ. The researchers kept one such organ, a 1.5-centimeter mini-heart, beating on its own for more than a week.

The researchers from Harvard Universitys Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS) say SWIFT produces organ-specific tissues that have high cell density and functionality, a critical step toward large-scale and safe organ replacement and other uses.

This is an entirely new paradigm for tissue fabrication, Mark Skylar-Scott, a research associate at the Wyss Institute and one of the studys co-authors, told ScienceDaily. Rather than trying to 3D-print an entire organs worth of cells, SWIFT focuses on only printing the vessels necessary to support a living tissue construct that contains large quantities of (organ building blocks), which may ultimately be used therapeutically to repair and replace human organs with lab-grown versions containing patients own cells.

As ScienceDaily noted, 20 people die daily while waiting for an organ transplant in the U.S. More than 30,000 transplants are performed each year but its still not enough to whittle down the long waiting lists of those in need of a suitable organ. More than 113,000 people are currently awaiting word that their wait has ended. Artificial organs could lessen or eliminate the shortage.

Replicated organs could also give doctors an opportunity to practice difficult surgical procedures, a chance to enhance their skills without fear of doing harm to human patients. Similarly, 3D-printed organs could remove the need to try out new pharmaceutical drugs on human or even animal test subjects.

The ink is barely dry on the Harvard researchers test, but the scientific world is hoping their discovery can be replicated for years to come.

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What is internal medicine? Dr. Stephen Gist has the answer – AZ Big Media

Posted: January 5, 2020 at 4:25 am

For many patients, navigating the medical landscape can be a challenge. While most individuals only require an annual checkup with their physician, more complex issues often require the attention of an internist.

Dr. Stephen Gist always knew he wanted to pursue a career in medicine. He has been practicing as an internist in Dallas, Texas, at Medical Specialists Associated for more than 21 years. Dr. Gist shares the ins and outs of internal medicine to give a better understanding of the profession.

Internal medicine has roots that go back centuries to Ancient India and China, where some of the earliest texts have been found, including the Ayurvedic anthologies of Charaka. Modern internal medicine can be traced back to the 1800s, when German physicians began incorporating different sciences to treat adults. Using bacteriology, physiology, and pathology, these physicians incorporated the knowledge they had to treat inner illnesses, which began to be known as innere medizin, or in common day English, internal medicine.

Internal medicine physicians are specialists that treat and manage complex medical issues for adult patients, explains Dr. Stephen Gist. Unlike family medicine physicians who manage a variety of patient loads, Dr. Gist explains that his patient load consists of patients with multisystem diseases or chronic illnesses that would benefit from specialized care that a single specialist would not cover adequately. His scope of practice covers a multitude of diagnoses that are not dependent on one disease process alone. Many internists practice in a clinic setting with hospital privileges to follow their own patients while some prefer to practice only in the hospital setting as hospitalists.

Dr. Stephen Gist

Although internists manage a wide variety of diseases and illnesses, some are common such as diabetes, hypertension, hypercholesterolemia, and heart and lung conditions. Internists help manage conditions through a multisystem approach, and can refer patients to subspecialists as needed, or when unsure of proper management plans for patients with worsening symptoms.

The path to becoming an internist generally takes a minimum of 11 years after completing high school. Most students will choose to take health or life science related courses during the first four years of undergraduate studies, during which time they will also study and sit for the Medical College Admissions Test (MCAT). After completing this standardized test, students apply for admission to medical schools, which at most schools is another four years. During the first two years, students take a variety of basic science courses such as microbiology, pharmacology, and pathology to get a basis of medicine before beginning their clinical rotations for two years. During these rotations, students go through different fields of medicine such as internal medicine, surgery, pediatrics, and psychiatry. It is during this time that students get a better idea of which field of medicine they would like to pursue and apply to residencies in. Once accepted, internal medicine residency programs are three years in length, in which residents get further training in the field and begin to transition to independent physicians.

For internists, daily schedules can vary depending on their hospital patient load and scheduled appointments. Generally, internists prefer to round at least once daily at the hospital to check up on their admitted patients, and if need be admitting new ones. Most internists have privileges at one or two hospitals in the area of their practice, explains Dr. Stephen Gist. The rest of their day is generally spent seeing patients in their clinic. Many who work at academic centers may have medical students and residents that work with them, and their schedules are similar, although they also tend to set aside teaching time as well.

For many physicians, internal medicine is the stepping-stone to further specialization in one of the many subspecialties recognized by the American Board of Internal Medicine. After completing a residency in internal medicine, physicians continue their training as a fellow for usually a minimum of three years. For those who want to be board-certified in multiple specialties, training can include multiple fellowships. Some common specialties include:

Cardiology- Cardiologists specialize to treat diseases that pertain to the cardiovascular system, namely the heart and blood vessels. Common conditions they see and manage include heart failure, peripheral vascular disease, heart blockages, and irregular heartbeats. Cardiologists could take part in procedures as well, such as performing angioplasty and stent placements in their patients.

Nephrology- Nephrologists are specialized to treat and manage conditions in relation to our kidneys explains, Dr. Stephen Gist. Most common conditions include nephropathies, chronic kidney disease, and patients on dialysis.

Pulmonology- Pulmonologists are responsible for seeing and managing patients with a variety of lung disorders such as pulmonary fibrosis, lung cancer, asthma, and chronic obstructive pulmonary disease. Many pulmonologists have dual specialization in both pulmonary and sleep medicine.

Gastroenterology- Gastroenterologists are responsible for seeing patients with issues related to the digestive system such as the stomach and intestines. Conditions such as intestinal bowel disease, irritable bowel syndrome, and stomach ulcers can be diagnosed and managed. Gastrohepatologists are physicians that help manage conditions related to the liver.

Geriatric Medicine- Like pediatricians, geriatric physicians are responsible for seeing a specific age group, the elderly. Geriatricians are involved in both preventative medicine efforts in the elderly, as well as managing conditions that are typically seen in older patients.

Many of the conditions that specialists see and manage daily are ones that internists also see in their patient population, however usually when symptoms are not as severe. Dr. Stephen Gist notes that all specialists and internists work hard together to help their patients achieve the best health outcomes.

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A healthy approach to the new year – AdVantageNEWS.com

Posted: January 5, 2020 at 4:25 am

The confetti is cleaned up and the New Year is underway. Millions of people are working on their resolutions, with some of the most popular goals centering on starting or improving healthy habits.

Some of the most popular resolutions focus on healthy eating, losing weight and quitting smoking or alcohol use. While all of these are important goals that reduce cancer risks, many forget to add preventative exams and screenings to their resolution roll calls.

Dr. Omar Khokhar is a gastroenterologist at OSF HealthCare St. Joseph Medical Center in Bloomington. He says simple screenings can save lives, especially when it comes to colon cancer. He suggests a simple conversation with your primary care provider to get the ball rolling.

Everything we know about medicine now is being proactive, Khokhar said. The days of getting sick and then going to the doctor are behind us now. Its about being proactive, looking ahead and doing things today that are going to ward off illness and sickness down the road. The best way to do that is getting screened. And in this particular case with colon cancer, its a completely preventable cancer, so why not get screened?

Colon and rectal cancers are on the rise in America, and at an alarming rate for younger adults. According to the American Cancer Society, since 1994, colon and rectal cancers have increased 51 percent among adults under the age of 50. These concerning numbers have prompted a shift in screening recommendations.

If you are 50 years old today and you havent been screened, you should be screened. And now the new guidelines from the American Cancer Society actually say age 45, Khokhar said. Thats a discussion you should have with your family doctor about whether you want to get screened earlier. But I think that we really need to focus on those two numbers: if you are 50 and you havent been screened, youre overdue. And if youre 45, its at least worth a conversation.

These screenings dont have to be intimidating. The gold standard in colorectal cancer screening is a colonoscopy. However, patients can also choose one of several other non-invasive tests, including home stool tests available by prescription.

Khokhar says to talk to your doctor about your options. However, dont limit your questions to your physician. When it comes to cancer screening recommendations, knowing your family history is important to help with early detection.

To learn more about OSF Medical Group's gastroenterology team and available screenings, click here.

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New Year’s resolution: Physical therapist intentionally gains weight to help people lose it – Livingston Daily

Posted: January 5, 2020 at 4:25 am

Jeff Cremonte, a physical therapist and president of LEAP Health, leads his father, Tom Cremonte, left, in a exercise at the Hamburg Fitness Center, Thursday, Dec. 19, 2019. He'll lead a free Facebook-based weight loss challenge.(Photo: Jennifer Timar/Livingston Daily)

If your New Year's resolution is to meet yourweight loss and physical fitness goals in 2020, you're not alone.

Dropping unwanted weight tops lists of the most common New Year's resolutions, but most people will abandon their quests or fail to reach their goals.

Jeff Cremonte, a doctor of physical therapy and founder of LEAP Health, which operates out of Grand Rapids and Hamburg Township, said he wants to help people stick to their weight loss resolutions in 2020.

Cremonte gained more than 20 pounds in the last few months so he can workto lose it along with other people.

"I wanted to gain weight to show my confidence in the scientific method," said Cremonte, 26,who splits his time living at his family home in Brighton and a place he shares with roommates in Grand Rapids."I wanted to put my own body on the line. My personal goal is to be down to my normal weight at the end of the challenge. We can be accountable together."

He said he normally weighs around 165 pounds and is now nearly 190 pounds.

He will beposting videos and other free informational materialson a Facebook group, "Drop withDoc." To join the group, submit a request atwww.facebook.com/groups/dropwithdoc.

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The Pinckney nativesaid he hopes to harness the power of social media to provide the five-monthweight loss challenge and educational series.

Over the course of five months, he will cover topics includinggoal setting, exercise, nutrition andlifestyle modification.

He said he has scientific, expert advice to shareas a professional physical therapist and fitness business owner.

He received his doctorate in physical therapy from the Duke University School of Medicine.

"In a world of social media, fads and a lot of weight loss diets, it's important to have a reliable source of information," he said.

Cremonte said putting on weight was a struggle, just like dropping weight can be.

"It's all caloric management, energy management," he said. "I changed to calorie-dense foods. To gain weight, you have to intake more calories. I was eating in surplus, at least 1,000 more calories a day consistently for about three months."

LEAP Health President Jeff Cremonte, left, helps his father, Tom Cremonte, do an exercise at the Hamburg Fitness Center, Thursday, Dec. 19, 2019. He will launch a free Facebook-based weight loss challenge on New Year's Day.(Photo: Jennifer Timar/Livingston Daily)

"Drop with Doc" will showcase hisown weight loss progress. He'll reverse his weight-gaining habits to weight-losing habits.

"I'm going to show you how I am going about it," he said.

Cremonte said his "Drop with Doc" program will ask participants to not rush into working out.

"At the beginning, we're going to take a step back, learn how to set goals and learn emotional strategies to remove barriers to being healthier. I'm not going to suggest people start working out until a week or two into the program," he said. "We'll be planning, like making house blue prints."

He willpost tips about meal preparation, changing daily habits and behaviors, exercises for weight loss and other related topics.

"It will primarily be videos, some of them more instructional, like me in front of a whiteboard. Other videos will give a live look, like I'll be at the store and I'm deciding between two foods, one healthy, one not," he said.

He said he hopes many of the Facebook group's members will post questions, progress updates and success stories, but he said there is no pressure to actively comment.

"If you want to join just to pick up a few pointers and check in and see what's going on, that's good too," he said. "They have the community there for accountability if they want it."

Cremonte said everyone's body is different when it comes to weight loss.

"Five months seems like a long time, but when it comes to real weight loss, that can take longer," he said.

"If you can lose a pound a week or even a pound every two weeks, that's a win," he said. "You want to set goals for behaviors, not results, because what you can control are your behaviors. I want to say, by May, that I worked out and ate correctly for the last five months, because that's something I can control. The weight isn't in your control. If you change the behaviors, the results will eventually come. Whether it takes five months or five years, over the long term, you're going to be successful."

USA Today reported that most people give up on fitness-related New Year's resolutions mere weeks into January, but some stick to them.

About 80%of resolutions fail by the second week of February each year, according to U.S. News & World Report.

Statisticportal Statista surveyed more than 2,000 adults in the country about their 2020 resolutions.Eating healthier tied with better managing finances, with 51% of survey respondents identifying one or both of those as goals. About 50% resolved to be more active and 42% want to loss weight.

LEAP Health is a business Cremonte founded in the summer of 2019. It offers one-on-one fitness, performance and preventative medicine services. Clients can work with Cremonte and other fitness professionals at their home, office or at one of two partnering gyms, Hamburg Fitness Center and Grand Rapids City Gym. More information is available at http://www.leaphealthy.com

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ContactLivingston Daily reporterJennifer Timar at 517-548-7148 or at jtimar@livingstondaily.com.Follow her on Facebook @Jennifer.Timar99 and Twitter @JenTimar99.

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NASA astronaut’s blood clot in space gets treated by doctor on Earth – SFGate

Posted: January 5, 2020 at 4:25 am

Amanda Kooser, provided by

NASA astronaut's blood clot in space gets treated by doctor on Earth

This article, NASA astronaut's blood clot in space gets treated by doctor on Earth, originally appeared on CNET.com.

It was like Grey's Anatomy in microgravity.

A NASA astronaut developed a blood clot (deep vein thrombosis - DVT) in the jugular vein partway through a long-term mission on the International Space Station. The space agency called in University of North Carolina doctor Stephan Moll, a blood-clot expert, to help develop a treatment plan for the tricky situation.

UNC School of Medicine blood-clot expert Stephan Moll at NASA.

NASA hasn't revealed the crew member's name or when the incident happened, though the astronaut discovered the clot two months into a six-month mission while getting a neck ultrasound for a research study.

When working with challenging cases, doctors often look to the medical record to see how previous occurrences have been handled. But there was no precedent for treating a blood clot in space.

"Knowing there are no emergency rooms in space, we had to weigh our options very carefully," Moll said in a UNC statement on Thursday.

Moll and a NASA medical team chose to treat the clot with blood thinners. The limited on-board supply of medicine required carefully meting out the dose until a fresh cargo shipment arrived from Earth.

The astronaut went through about 40 days of injections before switching to an oral pill. The NASA crew member discontinued the pills shortly before returning to Earth and required no follow-up treatment for the clot.

Moll co-authored a case study on the clot published in the The New England Journal of Medicine on Thursday.

The case study sheds some new light onNASA research published in November 2019 that looked into issues with astronaut blood flow during long-duration space missions. The report described the jugular clot in an otherwise healthy astronaut as "a newly discovered risk associated with spaceflight."

Moll and NASA scientists have called for more research into blood clots in space, including treatments and potential preventative measures.

"How do you minimize risk for DVT? Should there be more medications for it kept on the ISS? All of these questions need answering, especially with the plan that astronauts will embark on longer missions to the moon and Mars," Moll said.

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5 FDA approval decisions to watch in the 1st quarter – BioPharma Dive

Posted: January 5, 2020 at 4:25 am

The Food and Drug Administration cleared for market 48 new drugs through its main review office last year. Though that's lower than the 59 approvals seen in 2018, the agency's decisions still provided more treatment options for patients living with cystic fibrosis, sickle cell disease and rare muscular disorders.

Notably, the agency ended 2019 with a flurry of earlier-than-expected decisions, bolstering the 2018 count with several drugs it was scheduled to finish review on this year.

It's unclear how or if the approval stream will change in the new year and decade. The first quarter of 2020, though, may prove a bellwether in the near term. Between January and March, the FDA is slated to make calls on a handful of impactful drugs, including these five.

The odds are good that, before January closes out, Aimmune's Palforzia will receive approval to treat one of the most common food allergies. That's because the committee responsible for advising the FDA on whether or not to approve new allergy medicines recently voted in favor of the drug's effectiveness and safety. While the agency doesn't have to follow the guidance of advisory committees, it typically does.

Getting to market isn't the last hurdle for Aimmune, however. The company needs to secure insurance coverage, a task analysts expect will be more difficult if the drug comes at a high list price. Consensus on Wall Street seems to be that the company will set a list price somewhere in the range of $5,000 to $10,000 for the first six months of therapy, with lower costs thereafter.

Aimmune's case could also be complicated by clinical results that showed patients on Palforzia needed epinephrine injections about twice as frequently as those on placebo. The drug's labeling and risk mitigation strategy will therefore be closely watched.

"Overall, we remain cautious on the peanut category as a whole and believe out year consensus sales estimates for Palforzia seem overly optimistic given the complexity of the therapy and tolerability profile for a preventative treatment," Stifel analyst Derek Archila wrote in an early November investor note. The investment bank expects Palforzia sales to hit $65 million in 2020 and $800 million in 2025.

Lowering so-called bad cholesterol has been a profitable endeavor for some pharmaceutical companies. At its peak, Pfizer's Lipitor, now generic, was bringing in revenue of nearly $13 billion a year.

Lipitor is part of a drug class called statins, which continue to hold a significant portion of the cholesterol drug market despite the entry of newer medicines. Amgen's Repatha and Sanofi and Regeneron's Praluent, each a member of another drug class called PCSK9 inhibitors, have continued to fall short of sales expectations because of their relatively high cost.

Yet with roughly a third of the U.S. population having high levels of bad cholesterol, and statins being insufficient for some patients, companies remain interested in carving out market share for statin alternatives or additions. Amgen, Sanofi and Regeneron have shaved down the list price on their medicines, while Novartis in November agreed to shell out almost $10 billion to acquire The Medicines Company and its experimental PCSK9 drug.

Esperion may provide an additional option with bempedoic acid, a prodrug that inhibits an enzyme involved in cholesterol production. The Michigan-based company should find out by Feb. 21 whether regulators have cleared its drug. Another approval application for the combination of bempedoic acid and ezetimibe the active ingredient in Merck & Co.'s Zetia has a review deadline of Feb. 26.

Though Esperion's drug raised some safety concerns, a series of five late-stage trials support its efficacy. The FDA also didn't require an advisory committee meeting for the drug, which analysts said bodes well for its chances of approval.

Blueprint may get its first marketable drug with avapritinib, a treatment for patients who have certain kinds of gastrointestinal stromal tumors. The FDA is scheduled to make an approval decision by Feb. 14.

If approved, Blueprints drug would join a growing wave of targeted cancer therapies to reach market. That field has experienced an uptick in investment as well as big pharma interest, as evidenced by the recent buyouts of Loxo Oncology, Array BioPharma and Ignyta.

Avapritinib, however, has been the cause of some investor worries over the last few months. In late October, Blueprint disclosed that the FDA had split the drugs approval application which was going after two different portions of the adult gastrointestinal cancer population into two parts. The decision keeps one approval decision on track for the Feb. 14 deadline, but pushes the other back three months.

Analysts at SVB Leerink noted how this delay is problematic for Blueprint, as it could narrow the amount of time avapritinib has on market before the potential entry of a rival medicine from Deciphera Pharmaceuticals.

Allergan achieved an industry first last month, when its drug Ubrelvy part of a drug class known as CGRP inhibitors gained approval as an oral acute treatment for episodic migraine. Until that point, the FDA had only approved CGRP inhibitors like Amgen's Aimovig and Eli Lilly's Emgality, both injections, to prevent these severe headaches from happening.

But Ubrelvy may not have much time without direct competition. Biohaven's rimegepant, which, like Ubrelvy, is an oral CGRP inhibitor, could also gain approval in episodic migraine treatment before the end of the first quarter.

Piper Jaffray analyst Tyler Van Buren wrote in a recent note that, in light of Ubrelvy's approval, regulators are likely to sign off on Biohaven's drug as well. The investment bank models $40 million in rimegepant sales next year and more than $1 billion by 2024.

Bristol-Myers may have closed on its historic $74 billion Celgene acquisition, but its payments aren't yet complete. Former Celgene shareholders may still take home an additional $9 per share if three of the biotech's experimental drugs secure approval over the next two years.

One of those drugs is ozanimod, which targets the same receptor protein as Novartis' blockbuster multiple sclerosis medicine Gilenya.

Ozanimod has already faced one setback, when the FDA initially refused to review its application because of incomplete non-clinical pharmacology sections. Celgene resubmitted the application a year later, in March 2018, and expects to see an approval decision by March 25.

Despite the longer-than-expected regulatory timeline, ozanimod remains supported by positive clinical readouts. Salim Syed of Mizuho Securities USA contends that, "based on the data in the public domain, we don't see a reason for the drug to not get approved."

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Ads for drug injury lawsuits were a problem long before they targeted HIV prevention medication – The Verge

Posted: January 5, 2020 at 4:25 am

Facebook removed personal injury advertisements early this week that contained misleading information about medications designed to prevent the spread of HIV, after months of outcry from LGBTQ organizations like GLAAD, The Washington Post reported. Encouraging people at risk of HIV to take these medications is a key strategy in efforts to reduce the transmission of the virus so misinformation around this drug is especially concerning. But doctors and public health experts have been concerned for years about the risks posed by similar ads from personal injury lawyers, without the same level of public outcry.

These types of ads have been ignored for so many years, says Liz Tippett, a professor studying drug injury ads at the University of Oregon School of Law.

Lawyers spend millions advertising lawsuits that claim people were injured by a drug or medical device companys products. These ads are often on television and serve as a way to bring in new clients. The ads usually use strong language to highlight the potential harms or risks that come with a particular drug and that language can affect how risky consumers think a drug or medical device is. Most ads dont tell viewers to talk with a doctor, and some dont disclose that theyre sponsored by lawyers.

In this case, the Facebook ads were created by personal injury lawyers bringing lawsuits against pharmaceutical companies that make the medicine PrEP. The ads claim that the medication is harmful. Advocates warned that the ads scared patients away from the preventative drugs, which are considered highly effective by the Centers for Disease Control.

Research shows that these types of personal injury ads make people more likely to think a drug or medical device is risky, and can cause people to be less likely to decide to fill a prescription for a particular drug. In 2017, the US House Judiciary Committee held hearings on the advertising practices, and in 2016, the American Medical Association called for ads to include warnings that patients should speak to doctors about any concerns they have.

But patients havent mobilized around the issue before. Its very uncommon, says Lars Noah, law professor at the University of Florida. Its never reached the point that a community of patient activists would become alarmed. That might be because, before this point, advertisements typically didnt target drugs that were as important for public health as PrEP. Drugs advertised against to this point were often drugs that were marketed, but werent of a high therapeutic value, he says.

The response to these ads have also clearly focused on patient harm, Tippett says. In the past, trying to do something about these ads has been viewed as trying to help pharmaceutical companies, she says. This is the first really clear example of seeing consumer advocacy as the response.

The placement of these ads on Facebook brings up additional concerns not seen with television ads, she says: they can be targeted to specific demographic groups, which might increase their potency. Like on television, its not clear in many cases that the ads are sponsored by lawyers. Generally, these dont contain enough information to help people activate their natural defense mechanisms for this type of information, she says.

Facebook and other social media platforms are the sites of the next wave of these types of drug injury ads, says Jesse King, assistant professor of marketing at Weber State University. I think lawyers have been trying to figure out how to get these ads online for a while, he says. Ive heard their use is increasing.

However, social media may also have made it easier for the community responding to these particular ads to mobilize, Tippett says. It says who sponsored it, you can trace it back, and Facebook has an ad database. None of that is available when it comes to TV. In some ways, theres more potential accountability because theres a paper trail.

On social media, groups can also run counter advertisements to counteract drug injury ad messaging. Research shows that counter publicity may help to minimize or mitigate the impact ads have on perceptions of drug risk, she says.

The outcry over the PrEP advertisements, and the subsequent response, doesnt necessarily signal a shift in the way platforms, consumers, and lawyers handle drug injury ads, Noah says. The case is probably an outlier: the lawyers ads targeted a highly effective medicine and activated a particularly vocal community in response. Hes not optimistic it will trigger widespread change. But if it does, and leads to a closer look at the whole category of drug advertising by lawyers, I think that would be wonderful, he says.

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