Category Archives: Preventative Medicine

New year, new me, or so the saying goes. The start of a new year is a metaphorical clean slate and the perfect time to begin a healthier lifestyle. Its also a great time to be reminded of the monthly and annual health screenings you should be doing. Some screenings are performed by physicians at annual wellness visits, but there are also a few that you can perform yourself on a more regular basis. Both are essential if you are committing to your health through 2020 and beyond.

Doctors from a variety of specialties at Culpeper Medical Center - a Novant Health UVA Health System facility, explain some of these important screenings.

Skin Checks

Full-body skin checks are one of the most important preventative screenings you can do on your own. By thoroughly examining your body for new moles, dark spots or suspicious markings every three months, youre more likely to catch melanoma and nonmelanoma skin cancers before they have a chance to spread.

Early diagnosis usually means less invasive treatments, high likelihood of survival and lower chance that the cancer has spread, explains Shiv R. Khandelwal, MD, medical director of radiation oncology at Culpeper Medical Center.

The American Academy of Dermatology estimates that one in five Americans will develop skin cancer in their lifetime, but also reports a five-year survival rate of 99 percent when nonmelanoma skin cancer is detected and treated early. Despite high survival rates, it is vital to protect your skin from sun exposure and visit a dermatologist annually, in addition to at-home skin checks.

Blood Pressure Tests

High blood pressure (hypertension) puts increased strain on your heart and blood vessels, which over time can put you at greater risk of heart attack or stroke. John Hardy, MD, a cardiologist at UVA Cardiology, recommends having your blood pressure checked by a physician at your annual wellness exam.

Patients with hypertension may need to have their blood pressure monitored more frequently, and may be prescribed medication to help lower it, says Dr. Hardy. Its important to get a reading at least yearly so your doctor can note any changes.

Bone Density Exams

Bone mineral density measures the thinness of a persons bones and their risk of fracturing. Culpeper Medical Center offers screenings using a dual-energy X-ray absorptiometry (DXA) machine. This helpsstandardize a patients bone health to their demographic averages and determines the amount of bone density lost between screenings.

According to Pranav Patel, MD, chief of the department of medicine at Culpeper Medical Center post-menopausal women, tall and thin women, people with chronic kidney or parathyroid conditions, patients on long-term medication and smokers should have their bone mineral density read every two years. These are the populations most prone to osteopenia (thin bones) or osteoporosis (brittle bones), putting them at higher risk of fracture or traumatic fracture.

Mammograms

Although breast cancer can affect men, more than 99 percent of cases are in women. In addition to conducting monthly self-exams, all women should receive annual mammograms beginning at age 40.

Mammograms are very important, especially as women get older, says Jonathan Nguyen, MD, a breast-imaging specialist with UVA radiology group. We have the technology to detect abnormalities earlier than ever before, often before a woman would notice anything unusual in a self-exam. Through early detection, we can catch cancerous tissue and treat it before it spreads to another part of the body, which significantly improves outcomes and reduces mortality rates from breast cancer.

Culpeper Medical Center offers screening and diagnostic mammograms, as well as 3D mammography. This new mammography technology uses an X-ray arm to capture images of breast tissue one millimeter at a time and allows doctors to see fine details more clearly. All mammograms done at Culpeper Medical Center are read by UVA fellowship-trained breast radiologists, who can detect small cancers early in their progression.

Prostate Cancer

There is also a cancer screening specific to men: the prostate-specific antigen (PSA) test, which measures how much protein is produced by the prostate and can help determine risk of prostate cancer. Current guidelines from the U.S. Preventative Services Task Force suggest that men ages 50-69 discuss periodic PSA screenings with their doctors.

Ali Mahjoub, MD, a medical oncologist with UVA Cancer Care, explains, recommendations for screening come on a case-by-case basis between a doctor and the patient and are dependent on risk factors. These factors include family history, race and age. Age is the number one factor, and we typically recommend routine screenings beginning at age 50. Diagnosis in men under 40 are very rare but we can encourage men to be screened at a younger age if they are in a higher-risk category.

These are just a handful of health screenings and services offered by the providers at Culpeper Medical Center. Each is recommended for different reasons and may be more applicable to certain genders, age groups and ethnicities. Your primary care provider may recommend additional screenings for you, depending on your individual risk factors for certain conditions.

For more information about the services offered at Culpeper Medical Center, a Novant Health UVA Health System facility, please visit novanthealthuva.org/locations/medical-centers--emergency-rooms/Culpeper-medical-center.

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HEALTH: Starting 2020 on the Right Foot | InsideNoVa Culpeper - Culpeper Times - Inside NoVA

New research has developed a vaccine designed to prevent the neurodegeneration associated with Alzheimers disease, and researchers hope this will be the "breakthrough of the decade," according to ABC News Australia.The researchers believe that this treatment is now ready for human trials.

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The vaccine is created to produce antibodies that both prevent and remove amyloid and tau proteins in the brain, the accumulation of which is believed to be the main cause of neurodegeneration in Alzheimers disease.

Many previously failed Alzheimers treatments have focused either on amyloid or tau protein reductions, but never both. However, research increasingly suggests it is a synergic relationship between the two toxic proteins that may be responsible for neurodegeneration.

The novel vaccine is actually a combination of two vaccines. AV-1959R targets amyloid aggregations, and AV-1980R targets the tau protein ones.

Nikolai Petrovsky, a scientist from Australias Flinders University and one of the team's researchers, told ABC News Australia the new treatment could be both preventative and curative.

"It's actuallydesigned to be both a prophylactic and a therapeutic," he said.

"In the animal models, we can both use it to prevent the development of memory loss by giving it before the animal starts to get these build-ups of proteins. But we can also show that even when we give it after the animals have proteins, we can actuallyget rid of the abnormal proteins," added the researcher.

Now,Petrovsky hopes human trials can startin the next 18-to-24 months."It's an exciting time to be starting the new decade hopefully this is the breakthrough of the next decade if we can get it to work in the human trials," he said.

The research is being led and funded by the Institute for Molecular Medicine and the University of California, in the US. And we can only hope it ends up being a total success.

Read more:
Novel Dementia Vaccine Could Be the "Breakthrough" of the Decade - Interesting Engineering

Great hopes are being placed in a new vaccine that might be able to both prevent and cure dementia and Alzheimer's disease.

Developed by Prof. Nikolai Petrovsky, director of endocrinology at Flinders University in Adelaide, South Australia, after more than two decades of painstaking research and testing, this new vaccine's potential is so promising it's being hailed as the "breakthrough" of the decade in Alzheimer's research.

Petrovsky hopes human trials in the United States will start in the next 18 to 24 months. The vaccine was developed by Petrovsky but research is being led and funded by the Institute for Molecular Medicine (IMM) in California and the University of California in Oakland, which is the world's leading public research university system.

"With the vaccine, what we're doing is getting the immune system to make antibodies that can recognize those abnormal clumps of protein and will actually pull them out of the system and break them down," Petrovsky told ABC Australia. "It'll unblock the pipes and let the brain go back to normal."

The pipes Petrovsky refers to are the tens of billions of neurons in a healthy human brain. Neurons are specialized cells that process and transmit information throughout the body via electrical and chemical signals. They transmit messages between different parts of the brain, and from the brain to body organs.

Alzheimers disrupts the vital communication among neurons, causing loss of function and cell death. Early on, Alzheimers destroys neurons and their connections in parts of the brain involved in memory. It later corrupts areas in the cerebral cortex that are responsible for language, reasoning and social behavior. Many other areas of the brain will eventually be damaged. A person with advanced Alzheimers loses his or her ability to live and function independently. The disease is fatal within five to seven years.

"Currently, we believe Alzheimer's disease is caused by a build-up of abnormal clumps of protein in the brain," Petrovsky said. "It's like they gum up the system, a bit like when your pipes get blocked and they don't work so well.

He said the same thing happens in the brain with Alzheimer's. A person with the disease gets these build-ups of clumps of protein between the brain cells and they start to interfere with the communication between the brain cells.

Petrovsky is confident the human trials will turn out well.

"It's an exciting time to be starting the new decade -- hopefully this is the breakthrough of the next decade if we can get it to work in the human trials," he added. "It's an exciting juncture."

Petrovsky said the vaccine was designed to both be a preventative measure and a cure. He said that in animal models, the vaccine was used to prevent the development of memory loss by giving it before the animal starts to get these build-ups of proteins.

"But we can also show that even when we give it after the animals have proteins, we can actually get rid of the abnormal proteins. It's actually designed to be both a prophylactic and a therapeutic."

Increasing levels of protein from brain-derived neurotrophic factor (BDNF) gene expression could slow down the progression of Alzheimer's Disease. Pixabay

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Alzheimers Vaccine: Human Trials Expected To Commence In 2 Years - Medical Daily

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

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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A healthy approach to the new year - AdVantageNEWS.com

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

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."

Read more:
5 FDA approval decisions to watch in the 1st quarter - BioPharma Dive

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

The expansion of health coverage is certainly something to celebrate this holiday season. As 49,000 Idahoans and counting will have health coverage due to Medicaid expansion, we can all be grateful for the peace of mind, economic security and improved health that these families will enjoy. And we must continue to work together to help Idahoans get and keep the health coverage they need. As a physician practicing in rural Idaho, Im looking forward to more members of our community being able to receive preventative care and address chronic conditions that have gone untreated for far too long.

Medicaid makes it possible for low-income Idahoans to be healthy making sure they can work and take care of their families. It allows them to see a doctor when they are sick, get check-ups, buy medications and go to the hospital without fear of choosing between their health and groceries or paying their rent/mortgage. Medicaid offers financial protection for families so they dont have to go bankrupt when they face an unexpected illness or need to go to the hospital.

Medicaid expansion was achieved in Idaho through a bipartisan effort that included the support of former Gov. Butch Otter and several Republican lawmakers with deep knowledge and experience with Idahos health system. While a small group of Idaho legislators want to play Grinch and spread fear about people being kicked off private health coverage, the truth is that these Idahoans will still have health coverage without the burden of extra out-of-pocket costs that make their private plans difficult to afford.

Medicaid is more cost-effective and offers better health coverage for the vast majority of Idahoans who will qualify for Medicaid expansion. Efforts to keep some Idahoans who are newly eligible for Medicaid expansion on the state exchange would have cost taxpayers more money and added to the federal deficit, which is why the Trump administration rejected Idaho lawmakers request to do so.

Health care providers across Idaho, from hospitals, to physicians, to community clinics, have embraced Medicaid expansion and are working hard to enroll Idahoans and care for these individuals. As a physician, I know that Im looking forward to treating patients earlier before they have costly, more serious health conditions.

Medicaid expansion is a gift for Idaho. Idahoans who are struggling to make ends meet will now have access to health coverage and can receive preventative care to keep them healthy, or finally treat chronic conditions that have damaged their quality of life and ability to work. By 2022, Medicaid expansion will result in savings or offsets to the state totaling over $31 million, with a net savings of $3.5 million annually. Starting on Jan. 1, Idahoans across the state will have health coverage, reducing uncompensated care costs for rural hospitals, helping fund more Idaho physicians, saving local communities money and creating over $16 million in new economic activity. Its time to put politics aside and come together to fully support Medicaid expansion in Idaho.

Dr. Keith Davis is a family medicine doctor in Shoshone, Idaho and is affiliated with two hospitals in the Magic Valley. He is the owner, CEO and medical director of Shoshone Family Medical Center, where he has practiced for over 30 years. He received his medical degree from George Washington University School of Medicine.

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Medicaid expansion is a gift - Post Register

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.

The rest is here:
Ads for drug injury lawsuits were a problem long before they targeted HIV prevention medication - The Verge