Dr. Rachel Pearson got her start working with poor people in Texas, many of them people of color.

Which got her thinking about how doctors learn by making mistakes with those communities.

"We need to keep in mind what we owe to the people who have contributed the most to medical training and medical knowledge," she said.

Pearson is currently a medical resident at Seattle Children's, which she says is much different from her home state of Texas, where she worked in hospitals and clinics. She writes about that experience in her new book,"No Apparent Distress: A Doctor's Coming-of-Age on theFrontlinesof American Medicine."

Pearson spoke with Ann Dornfeld from KUOW's Race and Equity Team.

PEARSON: Students and residents learn from the poor. We learn our skills in poor communities and we make our mistakes in those communities. That means that now that I'm happily insured, and see my own private doctor, I'm seeing a doctor who has already made most of the mistakes that she's going to make, and the burden of her training fell on a much more vulnerable community.

I think that, as we consider health care policy, and as we consider the direction of health care in this country, we need to keep in mind what we owe to the people who have contributed the most to medical training and medical knowledge.

DORNFELD: What is it like to see such disparate health outcomes for people of color and low income people in this country?

PEARSON: It's embarrassing. It belies what I would like to believe about my profession and my society.

The disparate outcomes that are the most embarrassing to me are the ones that come directly from physician racial bias, which is known to independently influence health outcomes. So people with the same income, and the same access to care, and the same initial health status, have worse health outcomes independently because of race.

There's a study at theVA here in Washington state that looked at VA patients with diabetes and found that African-American patients were less likely to receive the standard of care treatment: yearly eye exams, having their hemoglobin A1Cchecked every three months. They also had shorter visits with their providers. And all of these disparities were linked to physician discomfort with taking care of minority patients. So bias alone has significant, and in some cases, deadly consequences for patients of color.

As a physician, I find that unconscionable. It is not the kind of data that we can sit on.

DORNFELD: How do you see that it can be fixed?

PEARSON: Most of the efforts happening right now, and these are good things, center around individual physicians acknowledging bias and using what are essentially mindfulness techniques to address it.

So we are taught to, number one look into ourselves, and know that we may be biased. To take this test called the Implicit Association Test that measures bias of different sorts. And to slow down deliberately slow down in patient encounters when we feel uncomfortable. The human tendency when you feel uncomfortable is to run away. And physicians need to do the exact opposite, which is slow down and ask more questions.

Now, all those efforts are incredibly important. But I do not think that individual physicians alone can fix the fundamental problems of racial bias in medicine and of racial health injustice. We also need policy. We need MCAT-blind policy to get more students of color into medical school. We need robust economic support for physicians who are practicing in communities of color. And we need ongoing medical education for those docs specifically aimed at the communities they serve, and driven by the communities they serve.

DORNFELD: Seattle is a wealthy city, with a lot of access to health care, even for low income people in a lot of ways. What do you see as inequities that still present, even at Seattle Children's?

PEARSON: I came to Seattle to see what it's like to practice in a place where the kids I care for could get all the resources they need. And it is a huge contrast between practicing here, where Medicaid has been expanded, there is robust access to care, and where the city and the county have invested in programs like Birth-to-Three that ensure that vulnerable kids can get early childhood services that they need.

That being said, with more and more working class and poor families being pushed out of Seattle and out of King County, the communities most in need of those services may not be able to access them.

This transcript was edited for length and clarity.

Read more from the original source:

'It's embarrassing': A Seattle doctor confronts racial bias in medicine - KUOW News and Information

EGG HARBOR TOWNSHIP Volunteers in Medicine of South Jersey will hold an open house Wednesday to introduce the public to its new, second location of free clinics.

Uninsured Atlantic County residents can receive free medical assistance at the new clinic. The organization has operated its first location in Cape May Court House for 15 years.

The clinic at 3073 English Creek Ave. in the Family Service Association Building has medical professionals and other volunteers who can provide health care and preventative medical services to people who don't have insurance.

The open house is from 6 to 7: 30 p.m. There will be light refreshments. Guests may tour the new clinic and ask questions about services.

Organizers have said Volunteers in Medicine was created to serve as a temporary safety net to support people who were between jobs, waiting for new health insurance or not eligible for Medicaid.

Volunteers in Medicine are vital to communities with low-income populations and ones that suffer economic hardships, especially in Atlantic and Cape May counties, they said.

A small percentage of patients treated in Cape May Court House came from Atlantic County, but directors said they now will be able to treat Atlantic County patients in Egg Harbor Township.

For more information, visit vimsj.org or call 609-463-2846.

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Open house Wednesday at new Volunteers in Medicine EHT clinic - Press of Atlantic City

OMAHA, NEB (KMTV) - The University of Nebraska Medical Center is working with the state to help students interested in medicine learn more about what they do.

Students took a tour of the biocontainment center at UNMC on Thursday.

The high school students say they have an interest in becoming a nurse and wanted to participate to learn more about the field they may pursue.

They got a walkthrough of the biocontainment unit to see what it takes to bring a person infected with a highly infectious disease to UNMC to be treated.

They also learned how these negative pressure rooms are disinfected after a patient leaves and what doctors must do to protect themselves but still ensure the best treatment.

Many students called the process eye opening.

"Just seeing where the Ebola patients were at, how everything works, just the different rooms, the different steps and processes to get in that unit."

Nurses used the 2014 Ebola outbreak as an example of how the hospital treated patients with a highly infectious disease in the past

UNMC staff say its important to familiarize the youth with careers that help save people's lives.

Continued here:

Students interested in studying medicine tour UNMC - KMTV - 3 News Now

Introduction

Editas Medicine (NASDAQ:EDIT) is a genome editing company focused on adapting CRISPR techniques for correcting human diseases. Although it just had its IPO in February of last year, it was founded in 2013 and is the oldest of the four major companies currently working to develop CRISPR-based medicines (their rivals being CRISPR Therapeutics, Intellia Therapeutics, and Caribou Biosciences).

On February 15, Editas, by way of their licensor Broad Institute, received a favorable ruling from the U.S. Patent Trial and Appeal Board (PTAB) regarding the crucial Cas9 CRISPR patent. Rocketing to the high 20's soon after, the stock has since fallen close to 50% over the past four months.

This article examines the factors which have lead to the slide since the PTAB ruling and argues that the selloff was overdone. But first, some background regarding Editas and its technology for context.

Science and IP Wars

CRISPR (short for Clustered Regularly Interspaced Short Palindromic Repeats) are actually DNA segments from bacterial cells functioning as part of the cell's immune system. However, they have been adapted with great success by scientists around the world for quickly and easily editing eukaryotic cell DNA, which is why they have received billing from the press as the "Holy Grail" of modern medicine. Many summaries have been written about the science behind CRISPR here and on other platforms, so that will not be the focus of this article (Editas' website gives a nice summary here).

Naturally, with such a powerful technology which could command billions of dollars, there will be battles concerning who owns the intellectual property rights. The two front runners right now are the Broad Institute (a biomedical research center composed of members Harvard and MIT) and another group consisting of the Regents of the University of California, Emmanuelle Charpentier, and the University of Vienna. Jennifer Doudna of the University of California Berkeley (UCB) was the first to use Cas9 to edit prokaryotic cells and filed a patent soon after. However, Feng Zheng of the Broad Institute worked quickly to apply the work to eukaryotic cells and paid extra to have his patent expedited. Initially, Doudna was one of the founders of Editas alongside Zheng, but bad blood caused her to leave and found her own company Caribou Biosciences. This boiled over into the aforementioned patent dispute, with the Broad Institute and their licensee Editas scoring a major victory. However, the battle wasn't quite over, which leaves us with enough background information to get started dissecting Editas' drop.

The Negative News Stream Surrounding Editas

"Ultimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR-Cas9 for use in all types of environments, including in non-cellular settings and within plant, animal and even human cells."

Were the Federal Circuit to rule against Broad in the appeal, this would be a significant blow for Editas since their flagship LCA10 program is currently using the Cas9 CRISPR variant. Their exclusive Cas9 agreement with Broad would be worthless, and they would be forced to scramble to work out some sort of agreement with UCB, the terms of which would undoubtedly be unfavorable for Editas. However, it appears the odds are stacked against UCB in undertaking the appeal. In 2016, the Federal Circuit upheld 75% of the decisions made by the PTAB. The Broad Institute has countered the announcement with their own press release. One passage notes an important consideration:

"The Federal Circuit does not independently weigh the facts determined by the PTAB. To overturn the PTAB decision, the Court would need to decide that the PTAB committed an error of law or lacked substantial evidence to reach its decision. Given the careful and extensive factual findings in the PTAB's decision, this seems unlikely."

The PTAB sided with Broad because they determined the jump from prokaryote to eukaryote using Cas9 was not obvious or trivial. This is a matter of fact and not of law, meaning that the Federal Circuit cannot rule on it. From this it appears that Editas and Broad are still in the driver's seat concerning Cas9 patent ownership (here is a source which goes into further detail regarding the case).

Given that the cash burn over the past two quarters has been around $80M total, one would expect at minimum the market penalizing the company for this amount since there will be two more quarters before the product timeline is set into motion. However, the drop since then came out to around $400M, which is significantly more. Additionally, there still may be some positives given that management is now working with Allergan in filing the IND and moving forward on the LCA10 clinical trials. Make no mistake, the slip-up is a strike against management, but the amount of the selloff is greater than what is justified by the two quarter delay.

Additionally, while most research effort is currently being focused on Cas9, Editas has also licensed the exclusive rights to Cpf1 from the Broad Institute. Here there is no legal dispute like with Cas9 and Editas' exclusive access to the patents remains safe. (source: company website)

Important to note is that Cpf1 is known for being particularly selective in its determination of targets for editing. On top of that, Editas has developed a proprietary platform called "UDiTaS" with the goal of detecting and monitoring both on-site and off-site edits. This will help them in assessing and preventing any unintended consequences of Cas9-based editing.

It's Not All Bad News Being Released...

This was excellent news for several reasons. It showed management's ability to negotiate deals with big pharma, which will be necessary to get products to market without significantly diluting shareholders. It also demonstrated the confidence of companies like Allergan in the ability of Editas to execute on its project timelines. Editas is already leveraging Allergan's help in filing the IND and setting up the clinical trials for LCA10. The input from an experienced team like Allergan's will surely be invaluable moving forward. And finally, the upfront payment from the deal comes at a time when Editas desperately needs cash to get the clinical trials for LCA10 off the ground.

"For animals treated with the higher dose, the projected productive editing rate may be as high as 50 percent in photoreceptor cells, based on directly measured editing of 15 percent in total genomic DNA and an estimate for the proportion of cells represented by photoreceptors. Achieving 50 percent of all alleles would be well above the editing rate hypothesized to have a therapeutic effect in patients."

This provides a great deal of confidence in the LCA10 program going forward since the editing level was deemed high enough to have a therapeutic effect. Additionally, Editas released pre-clinical data from their program to treat blood diseases like Sickle Cell and Beta-Thalassemia. The experiment involved editing human stem cells outside of the body and infusing them in mice. Editas' analysis of the editing frequency and hemoglobin data showed that this approach may be more effective than others currently reported.

The excitement behind SHERLOCK is due to its potential to rapidly and cheaply detect many different afflictions, such as Zika, cancer, and even the risk of heart disease from saliva. Broad's researchers have said they are looking for ways to commercialize the technology, and given their history of licensing tech to Editas, it's definitely not out of the question that Editas may be involved with this technology in the future.

Risks

As Editas is an early stage biotech company with any potential products many years away from release, the risks are self-evident. On top of the current lack of products, the patent licensed for Editas' lead development program is under heated legal dispute, which is expected to be an overhang for the next few years. Editas' cash burn is significant, and despite having $352M currently on the balance sheet, their funding stockpile is only expected to last around two years.

(source: generated from company 8-K's)

In the worst case scenario, Editas is never able to achieve a viable product and is forced to dilute shareholders into oblivion. However, Editas has an alternative method for raising capital: R&D alliances that come with upfront payments and milestone awards. Potential milestone payments from Allergan and Juno Therapeutics could soften the need for issuing equity in the future. Additionally, Editas can negotiate deals with other companies on new programs which are not currently covered by the Allergan and Juno ones.

Conclusion

Editas has seen a significant amount of downward pressure recently due to a stream of negative news which has surfaced. In this article, I have addressed why many of these issues are overblown, as well as presented other positive news pieces which are important to consider. Given the infancy of the technology and the risks involved, I would not recommend Editas as a core holding. But for investors looking for a small speculative position which has the potential for a 10x gain if everything goes right, this looks like a good entry point.

Rating: Speculative Buy

Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in EDIT over the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Editas Medicine: Addressing The Negatives - Seeking Alpha

To say primary care physicians (PCP) feel like they are struggling is an understatement.

Between constant changing government regulations (were looking at you MACRA), and the ever increasing pressure to please patients while battling electronic health records, it is no wonder burnout has become a constant topic of discussion amongst PCPs.

With so many changing variables these days, it has become even more important to maintain a steady income. Knowing whether or not your salary is amongst thehighest, orlowest, in the country comes in handy when attempting to combat these struggles.

According to the Bureau of Labor Statistics (BLS), the mean annual wage for internal medicine physicians is $201,840.

The top states with the most internists are Texas, California, Ohio, Florida and Massachusettsbut none of these states are among the top paying locations for internists and in fact, one is on the list of lowest-paying states, the BLS reports.

Read on to find out which states the BLS says were the highest, and lowest, paying states for internal medicine this year.

Original post:

Top 10 highest, lowest paying states for internal medicine - ModernMedicine

MedCity News

What all this cancer news means for medicine at large MedCity News Founded in 1991 in Salt Lake City, Utah, the molecular diagnostics company has long been a leader in genomics and precision medicine, first with hereditary cancer tests, then with companion diagnostics and tests that could inform prognosis and ...

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What all this cancer news means for medicine at large - MedCity News

The Hindu

Thousands administered fish medicine in Hyderabad The Hindu With great belief: (Left) Asthma patients being administered fish medicine by a member of Bathini Goud family at Exhibition Grounds at Nampally on Thursday. Hundreds of people waiting for their turn to receive the medicine. | Photo Credit: G_RAMAKRISHNA. and more »

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Thousands administered fish medicine in Hyderabad - The Hindu

The greatest mistake in the treatment of diseases is that there are physicians for the body and physicians for the soul, although the two cannot be separated Plato

Attending physicians, the physicians who train interns and residents on hospital wards, have always borne a heavy responsibility. They are accountable for the level of medical care received by each succeeding generation of American patients. But today, these physician-teachers confront unprecedented obstacles. How well they meet the challenge may have long-term consequences for patients and for the medical profession as a whole.

This turning point in medical education was the inspiration for our in-depth study of 12 of the nations outstanding attending physicians. We observed them as they interacted with learners and patients, and interviewed them, as well as some of their past and present learners, to provide a glimpse of what the future of clinical education could look like.

The most important form of clinical training takes place at the patients bedside, yet attending physicians have less time to spend with learners on patient rounds. Due to the mandated reductions in the length of the learners workday and because hospitals are discharging patients sooner than ever before, there are fewer hours for learners to follow the care of any one patient. Meanwhile, learners continue to spend a great deal of their limited time behind a computer screen documenting care rather than administering care.

Attending physicians must also cope with a seismic change in the hospital environment. In days past, they personally provided or oversaw most of their patients hospital care. That is virtually impossible today. Attendings are now part of an interdependent team that encompasses not just learners but nurses, pharmacists, radiologists, and other specialists. Teamwork requires such personal qualities as empathy and communication skills, which were not particularly noticeable among attendings of previous generations. Those same qualities are in demand as hospitals have become more focused on satisfying patients (aka customers) rather than physicians; hospitals expect their physicians to view patients as partners in their care and to treat them with a full measure of respect.

The most important form of clinical training takes place at the patients bedside

Although the 12 attendings exhibited a variety of individual behaviors and techniques, we found that they shared a dedication to the following central propositions: the team environment should be supportive, and the teaching should be team-based and patient-centered.

A supportive environment

The 12 attendings set high standards for their medical team (typically a senior resident, two interns, and several medical students) but they were aware performance anxiety is not conducive to learning. They created an atmosphere that was cooperative and trusting, rather than competitive.

To achieve that goal, the attendings established personal connections with individual team members, exchanging life experiences and jokes. The attendings emphasized that they themselves were students, always learning, and urged team members to challenge their findings when there was a disagreement.

The attendings used their own past mistakes to illustrate their teaching and to demonstrate that mistakes, though obviously to be avoided, will happen and are an essential aspect of learning. Major missteps were corrected in private to keep from publicly embarrassing learners.

Bad outcomes can take a heavy emotional toll on learners. We saw how one of the attendings helped his team cope with the death of a patient. We should reflect on what happened, but not lose our confidence, he told them. The day after he died, I sat in my truck and did a personal pep talk. You have to come in and take care of the next patient and do the best you can.

Team-based learning

The 12 attendings put the team in charge of patient care, while demonstrating that they were available, 24/7, when needed. They positioned themselves as members of the team, rather than the leaders; giving that task to the senior resident. The teams were constantly told to question every diagnosis and every treatment plan, to develop and test multiple hypotheses and alternatives.

The attendings engaged their teams in discussions of a few key points, rather than delivering lectures filled with facts to be memorized. Instead of simply correcting a learners conclusion, the attendings would ask the learner to explain, step by step, how he or she got there. The Socratic method of questioning was used to explore learners understanding of the material and guide them toward the best answers.

The attendings shared with their team their own reasoning process in arriving at a diagnosis or treatment of a patient. In their capacity as role models, they wanted to show how seasoned physicians think about medicine.

Patient-centered teaching

In their behavior with patients, the attendings modelled the kind of safe patient care they expected of their learners. They washed their hands before and after every patient visit; they placed the stethoscope directly on the skin rather than over the patients gown when listening to the lungs or heart.

Before going on rounds with their teams, the 12 attendings reviewed the medical records of their patients allowing them to prepare some key teaching points during rounds.

The 12 attendings sought to create rapport with patients, greeting them in a friendly, upbeat manner; empathizing with their discomfort; explaining medical issues in laymans language. Patients were treated with kindness and humility.

The concern for patients welfare extended to their post-hospital lives. The attendings started their teams thinking about the patients discharge when the patients first arrived on the unit, and included for example, proper transportation home options, patient care at home, and patient insurance coverage.

The 12 attendings recognized their responsibility to model for their learners what it means to be a physician in todays challenging healthcare environment. One of the most impressive qualities about these attendings was that they loved being physicians andteachers. This description from one of the former learners sums up the 12 physicians as a whole: He was a doctor who loved taking care of patients and loved teaching. He was never there to just get through something, but very present and very excited about what he was doing.

If the future of clinical education rests in the hands, minds, and hearts of physicians such as these, learners and patients will be well served.

Featured image credit: Hospital by skeeze. CC BY 2.0 via Pixabay.

Read more:

Teaching medicine: how the great ones do it - OUPblog (blog)

Science Translational Medicine has retracted a paper by researchers based in Switzerland, after an investigation concluded two figures had been manipulated.

The investigation occurred at theUniversity of Basel. Its not clearwhat prompted it, but the paper has been discussed at length on PubPeer. After the investigation concluded two figure panels included manipulated data, the last author asked to retract the paper.

Heres the notice:

Following concerns raised about potential data manipulation, the University of Basel conducted an internal investigation. This evaluation established that data had been manipulated in Figure 2A and Figure 3. Given that the integrity of the manuscript is compromised, the corresponding author Michael Sinnreich has requested that the Research Article be retracted. Thus, Science Translational Medicine is retracting the paper in full.

Proteasome inhibitors increase missense mutated dysferlin in patients with muscular dystrophy has been cited eight times since it was published in 2014,according to Clarivate Analytics Web of Science.

One month after the paper appeared online in August 2014, a user on PubPeer raised a question about another figure panel, 2B. Another commenter tagged as author (and signing the note as last author Michael Sinnreich) uploaded an image of the entire blot used in figure 2B. However, that prompted additional comments from readers, who allege the published image has a much higher resolution than what the author shared, and some bands still appeared identical.

We contacted Sinnreich, who referred us to a university spokesperson.

First author Bilal Azakir is now an assistant professor at Beirut Arab University; he declined to comment further, and referred us to the retraction notice.

Update, 00:44UTC time, June 9, 2017: We received a statement fromEdwin Constable, Vice President for research of the University of Basel, earlier today:

The University of Basel was alerted to a possible problem with this publication by the lead scientist. The initial alert stemmed from the discussion on PubPeer. The University of Basel implemented its established procedures for cases of potential scientific misconduct. As a result of these procedures, we recommended the retraction of this paper.

We cannot make statements regarding either the nature of and responsibility for potential misconduct or any additional retractions.

Like Retraction Watch? Consider making atax-deductible contribution to support our growth. You can also follow uson Twitter, like uson Facebook, add us to yourRSS reader, sign up on ourhomepagefor an email every time theres a new post, or subscribe to ourdaily digest. Clickhere to review our Comments Policy. For a sneak peek at what were working on,click here.

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Data had been manipulated: Science Translational Medicine retracts paper - Retraction Watch (blog)

According to Columbia University, narrative medicine fortifies clinical practice with the narrative competence to recognize, absorb, metabolize, interpret, and be moved by the stories of illness.

Although it seems like medicine and creative writing may have no similarities, the Narrative Medicine program at Baylor College of Medicine is proving otherwise. One of the ways the program is forging this connection is through an event called Off Script: Stories from the Heart of Medicine.

In the Q&A below, Dr. Ricardo Nuila, assistant professor of medicine at Baylor and a founding member of the Narrative Medicine program, discusses his interest in narrative medicine, how it can be used to help strengthen the link between healthcare providers and patients, and the Off Script event.

Q: How did you first learn about narrative medicine? A: Ive been interested in creative writing and literature since college. As a resident in internal medicine at Baylor, I began writing short stories. Then someone told me there was a field that combines creative writing with medicine. I did some research and found that Columbia University offered a Narrative Medicine program. I ended up going to one of their workshops and after that it seemed to be a good idea to build upon at Baylor.

Q: How has the Narrative Medicine program at Baylor evolved? A: We are still growing but now we are part of the Center for Medical Ethics and Health Policy. A lot of the programs growth at the beginning came from word-of-mouth. It began as a group of like-minded colleagues, and then it became something that interested other people.

Q: How do you educate health professionals through the Narrative Medicine program?A: We put on skill-building workshops at different levels. A typical workshop would be a noontime lecture where we hand out a short piece of literature such as Indian Camp by Ernest Hemingway. After participants read the story, they write something according to a prompt we give them. We then have a discussion tailored around a medical topic. Discussing stories is not just for fun, it helps increase analysis and communication, skills that everybody can benefit from.

Q: How does narrative medicine help promote a more holistic understanding of patients?A: Narrative medicine is about storytelling and respecting complex stories. For instance, when I talk to a patient, Im looking at a lot of details about that patient separate from what he or she might say. A hat, or how he or she is dressed, word use, an accent all of these things are data points in your head that help you shape this persons story. This process can also help with planning for possible hindrances the patient might face once they leave the hospital so you may be able to bypass them.

Q: How can storytelling help physicians be more thorough and empathetic?A: When I think of someone in story terms, I become more interested in his or her life and I find myself learning from the patient. Its not uncommon for me to ask patients questions like, What part of Texas or Mexico are you from? or How did you get here? When I take in all of those data points and I can see more of the patients story, I understand them better.

Storytelling also helps me develop a better ear for how a patient speaks, which can tell me what kinds of words to utilize to convey the message. I want patients to be engaged with me so I am aware of how Im using my words.

Q: Can you tell me more about Off Script: Stories from the Heart of Medicine?A: Off Script is one of our community outreach programs. I would describe it as a medical storytelling event. As a medical student and resident here at Baylor, I would see doctors, nurses and physicians assistants all huddled up telling stories about their experiences. The Off Script event is a chance for us to cultivate these stories.

For this Off Script event, the topic is Scrubbed. Stories are accepted through submissions so that we can help develop them. We work alongside writers to improve storytelling, writing technique, and delivery. We want each story to resonate with the audience.

Off Script takes place from 5:30 to 6:30 p.m. on Wednesday, June 14 at the UT McGovern Medical School, room MSB 2.135. The event is free and open to the public.

-By Julia Bernstein

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How narrative medicine closes gap between physicians and patients - Baylor College of Medicine News (press release) (blog)

Australia Proposes New Risk-Based Approach to Medicine Variations Posted 08 June 2017 By Zachary Brennan

Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement.

"These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before implementation by the sponsor."

TGA says that such a risk-based approach to the management of variations to medicines, which will be only for changes that do not impact the quality, safety or efficacy of a medicine, will reduce regulatory burdens on industry, reduce unnecessary assessment work for TGA and allow for variations to take effect more quickly.

A list of variations that are acceptable for notification only will be developed, TGA adds, noting that it is looking to generally align with European Medicines Agency requirements.

However, changes to Australia'sTherapeutic Goods Act 1989are needed to implement this new notification process, TGA says, noting that it has introduced into Parliament a bill to amend the act, as well as amendments to theTherapeutic Goods Regulations 1990outlining the first set of changes proposed as notifications.

Other upcoming regulatory reforms were also outlined by TGA last September.

Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected

Continue reading here:

Australia Proposes New Risk-Based Approach to Medicine Variations - Regulatory Focus

The future of precision medicine doesnt lie in some theoretical construct but is here now in the form of digital tools that are currently available to providers and patients alike.

Thats the contention of Eric Topol, MD, director of the Scripps Translational Science Institute and a keynote speaker at Wednesdays opening session of the 2017 AHIP Institute & Expo in Austin, Texas.

However, before healthcare can take full advantage of a personalized approach to healthcare that treats individualsnot populationsthe industry needs to come to terms with its failed ways.

Medicine today is in a pretty sorry stateits sad to admit, and we have to face the problems we have, said Topol, who contends that imprecision is a root cause of the inefficiency and waste in medicine. We have this illusion that we provide such great healthcare in this country, and its so far from the truth.

Despite the billions of dollars spent developing medications, he pointed to the fact that 75 percent of patients who are prescribed the 10 top-selling drugs dont respond to these pharmaceuticals. In addition, Topol noted that the medical error problem in healthcare is profound, representing the third leading cause of death in the United States; in addition, 12 million Americans are misdiagnosed each year. Further, he said that one in four hospitalized patients are harmed while in the care of clinicians.

Were talking about at least $1 trillion of waste per year because of this imprecision of not seeing people as individuals, but rather (using) this population medicine approach, according to Topol. There is no one who is averagethat person doesnt exist.

Leveraging the available technology to understand each human being is where medicine needs to go in the 21st Century, he said. Whats needed is to map the human body, providing a Google Medical Maps equivalent. But, instead of the satellite street view and traffic view, you have the views of the persons phenome, external features, their DNA, RNA proteins, their epigenome, their microbiome and their exposome, added Topol.

According to Topol, mobile technology is the enabler for measuring human physiology. Today, we can use smartphones to accomplish a lot of this understanding of each individual, he said. And, the smartphone will indeed be the hub in the imminent years of medicine because there are sensors for every physiologic metric.

At the same time, Topol insisted that these medicalized smartphones will serve as technological enablers for the democratization of medicine, giving patients control of their own data, which has historically been the exclusive domain of physicians.

Also See: Medicalized smartphones to put health data in hands of patients

One of the mobile devices that Topol is particularly keen on is smartphone ultrasound. You can now get high-quality, high-resolution images through your phone of any part of your body except the brain, because you cant image through the skull, he added.

A cardiologist, Topol said he also uses a portable echocardiogram through his smartphone to monitor a beating heart.

Why would you ever listen to a persons heart with an obsolete stethoscope? he asked. It isnt even a scope. Its a stethophone. This is really a big shakeup in healthcare, and the fact is that most doctors are not using this. Theres only one reason why it isnt being used. It has something to do with the big Rreimbursement.

Health payers are in the drivers seat here, and theres no entity that has the power to change medicine as insurers, so Im hoping they will buy into these really exciting times that we are in, concludes Topol. We have the tools to do it. Hopefully, we have the will to do it.

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Topol: 'Imprecision' medicine is plaguing healthcare - Health Data Management

OMAHA, NE - Nine donors got to meet the nine people who received their kidneys Thursday during the largest living kidney donor chain in Nebraska history at the Nebraska Medical Center.

It was the first time that they met face to face. All nine transplants happened from February 27-March 3.

Many of the patients wanted to donate to a friend or family member but were matched to others on a Board of Hope.

Donating a kidney is one of the most courageous and noble acts a person can do. Sitting among all of you are 9 superheroes willing to donate a kidney to someone they had never met, knowing only that their friend or family member would receive a kidney in return, said Dr. Arika Hoffman, an NMC Transplant Surgeon.

The youngest recipient, 5-year-old Andy Aranda, concluded the chain and got to meet his donor Thursday. His father says hes needed a new kidney since he was 2-months-old.

He loves superheroes and riding bikes. Now, he knows a real life superhero, his donor, Tyler Sturgeon of Cozad, NE.

People like Tyler he shared his life and his organs for another person its a miracle, said Jesus Aranda, Andys father.

Sturgeon signed up to donate to his close friend, Ricky Love, but is excited to know his friend will live longer and so will the vibrant 5-year-old.

I was happy. Thats two people better than one. So I was like part of the exchange absolutely sign me up for it, and being part of nine makes it even a little more exciting, Sturgeon explained.

Previously the largest living-donor kidney chain at NMC was between three people in 2016.

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Nebraska medicine hits transplant milestone - KMTV.com - KMTV - 3 News Now

University of Chicago Medicine announced Wednesday that it plans to open its new emergency department in January and begin offering trauma services long absent from Chicago's South Side in May.

The opening and new services follow years of campaigning by activists for urgent, high-level medical care on the South Side which hasn't had such care since Michael Reese Hospital in Bronzeville closed its trauma center in 1991.

The University of Chicago emergency department is slated to open Jan. 8. Trauma services, which start May 1, will include care for patients with life-threatening injuries from car accidents, burns, serious falls and gunshot wounds. Those dates are pending approval from the Illinois Department of Public Health.

The Illinois Health Facilities and Services Review Board unanimously approved plans for University of Chicago Medicine's project last year, and construction on the $43 million emergency department project began last fall.

The new emergency department, which is being built from a converted parking garage, will be 76 percent larger than the current one. It will include four trauma bays for treating patients, private patient rooms rather than spaces divided by curtains, and separate entrances for emergency medical service workers and patients who arrive on their own.

University of Chicago Medicine also plans to add a dedicated cancer hospital to its University of Chicago Medical Center campus. The overall project, including the expanded emergency department, is expected to cost $269 million and add 188 beds.

Earlier this year, University of Chicago Medicine hired Dr. Selwyn Rogers, from the University of Texas Medical Branch, as founding director of the trauma center. So far, University of Chicago Medicine has also recruited five of six additional trauma surgeons.

lschencker@chicagotribune.com

Twitter @lschencker

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University of Chicago Medicine's new emergency department to open in January - Chicago Tribune

The Hindu

Bathini to start annual fish medicine distribution The Hindu Hyderabad: The yearly 'fish medicine' distribution, organised at Nampally Exhibition Grounds will commence at 8.30 am on Thursday. This year Bathini Mrigasira Karthi Fish Prasadam trust is ready with 3.5 kilo grams of fish made to satisfy four lakh ... and more »

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Bathini to start annual fish medicine distribution - The Hindu

In the second half of its 46th season, the Vail Symposium presents a diverse lineup of more than 20 thought-provoking events, starting today with Integrative Approaches to Patient Care.

Dr. Donese Worden, N.M.D, kicks off the program's Consciousness Series with a lecture today and a workshop on Friday.

As an Arizona-based clinician, Worden has been recognized for her intelligence, experience, compassion, cutting-edge research and quality of care.

At her lecture, Worden will talk about treating the patient as whole, sometimes by prescribing medication and other times by using botanical medicine most times using both.

At Four Seasons Resort in Vail, Worden will discuss how her integrative approach empowers her patients and contributes to their healing.

Worden has been featured on the cover of the National Speakers Association's magazine and as one of Phoenix magazine's Top Docs. She is also an adjunct professor at Arizona State University, where she teaches integrative medicine.

WORKSHOP, Friday

The day following the lecture, Worden will lead a workshop, Transformational "Ah-ha" Moments in Medicine, working with patients to identify core issues that cause most of their health problems.

Worden will also present natural and holistic options for addressing those problems. The transformational workshop will present scientific information in a fun and exploratory setting.

The Symposium's Consciousness Workshop takes place Friday from 9:30 a.m. to 1 p.m., at Four Seasons Resort in Vail. Cost is $40.

For more information about Worden's lecture or workshop, or upcoming Vail Symposium events, visit http://www.vailsymposium.org.

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Vail Symposium program discusses holistic approaches to medicine June 8 - Vail Daily News

Hearing the word precision in healthcare typically conjures ideas of cutting edge technologies and treatments like targeted genetic therapy. But it has another meaning in primary care: leveraging data from a variety of sources to deliver personalized, preventive care.

Its a way to bring the big data whether that is on the population level, from digital health devices like wearables, or additional insights from omics diagnostic tests into the clinical practice, Dr. Megan Mahoney, who is chief of general primary care at Stanford Universitys division of Primary Care and Population Health, told MobiHealthNews. Then we ask, how do we synthesize data to identify a patient out of a large population who can be managed and treated to prevent an adverse outcome, disease worsening, or hospitalization?

Its exactly that question that Mahoney and her colleagues are trying to answer, and she will share details about a new program underway at Stanford during HIMSS Precision Medicine Summit in Boston next week.

While the core goal of precision medicine is to determine which specific disease or health indicators can guide tailored interventions, much of that promise is focused on people who are actively in treatment for disease. Stanford Health Care wants to move that process upstream and redesign primary care practice.

Precision medicine, as we hear about it, is more focused on crafting a tailored treatment once a diagnosis is made. What is interesting to me right now is less about how to tailor sophisticated treatment to specific diseases and more about upstream strategies to prevent disease worsening, Mahoney said. Focusing on prevention is where the country needs to go right now in order to rectify the healthcare crisis we are facing now."

First off, that means getting more hands on deck in care delivery.

Historically, the physician has preferred to provide very individual care to very individual patients, and we have to start moving towards team-based care, Mahoney said. A more team-based care means providers and physicians can practice at the top of their license, focusing on assessment, diagnosis and treatment rather than administrative tasks or other protocol requirements that could be passed on to another care team member, like a health coach or physical therapist.

To do that, they will begin a yearlong pilot with 50 to 100 patients from demographically and socioeconomically diverse backgrounds, and will identify ways to reach them to offer preventive care and engagement opportunities based on electronic health records dashboards. From there, they can identify patients who could benefit from genetics counseling or sequencing as well as discern which outreach and educational methods have the best engagement outcomes. Chief Medical Information Officer Christopher Sharp (who will co-present with Mahoney at the Summit), will be responsible for leading the team in building out technological interfaces to create registries and data analytics capabilities.

Well be able to see which patients are most likely to benefit from precision healthcare, such as those with multiple chronic conditions or those who could benefit from pharmacogenomics testing, and we will be reaching out to them in several ways, Mahoney said. The pilot will primarily aim to assess the feasibility and acceptability of such a model, Mahoney said. They will work to provide interventions in a mode that is preferred by the patient, taking care not to overload them with a barrage of new technology. The pilot will intentionally recruit some patients who are already using wearables, and the only new tool introduced will be the HealthPals platform.

Ultimately, Mahoney said, the pilot will seek to demonstrate that healthcare teams can respond efficiently and effectively to big data and reduce costs through methods that are scalable.

Everyone is facing economic pressures to reduce costs, and we are really looking at the future at Stanford to demonstrate how we can give better care when physicians are solely focused on practicing at the top of their license rather than being used as a secretary to document notes through Epic when they could be using devices or tools to generate that data, said Mahoney. We need to get away from this situation we have now where patients are generally unhappy they only interact with their doctors for 15 minutes. They get to know their dogs veterinarian better.

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How Stanford Health Care is bringing precision medicine into preventive primary care - MobiHealthNews

For the last two years Norma Camero Reno has been shipping a steady supply of desperately needed medicines from the United States to Venezuela. Reno and other members of her nonprofit, Move Foundation, pack painkillers, cold medicines and other supplies to be distributed to hospitals, health clinics and churches throughout the beleaguered nation.

Two weeks ago, however, that all changed.

Reno, a Venezuelan-born, Tampa-based lawyer and founder of the foundation, said that for years her organization faced very little pushback from the government of Venezuelan President Nicols Maduro when sending packages of food and medicine to the country. But when she arrived in the small, Venezuelan coastal city of Barcelona two weeks ago, Reno discovered that none of the recent medicine shipments had made it to her contacts in the country.

While the group has in the past had to deal with Venezuelan officials confiscating food shipments, this was the first time that medicine has been stopped from being delivered.

They are stopping everything from going in, Reno told Fox News. They are taking everything for themselves.

Venezuelans have struggled in recent years to get their hands on all types of medical supplies from over-the-counter painkillers to infection-fighting antibiotics as the country grapples with widespread shortages and soaring inflation rates brought on by economic mismanagement from the socialist government in Caracas. The lack of equipment like respirators has become so dire thatbabies are dying in maternity wardsfrom commonplace infirmities that are now considered life-threatening.

Social media has erupted with pleas from many Venezuelans for groups to send prescription medicines to fight illnesses from diabetes to cancer.

Amid the shortages, the Maduro administration has banned numerous items sent to the country from aid agencies and families living abroad. Along with firearms, gas masks and bullet-proof vests, Venezuela has banned innocuous items like antacids, latex gloves, Gatorade and Neosporin.

Along with Move, numerous other organizations have been thwarted in their attempts to send supplies to hungry and ill Venezuelans. Many of the items that the nonprofit Sanando, which has operated in Venezuela for over 10 years, sends to the country are now banned. Caritas, an international NGO linked to the Catholic Church,told Fusionthat it has tried three times in the past month to get an import permit to bring medicines and food into Venezuela, but has so far been ignored.

Lilian Tintori, the wife of jailed opposition leader Leopoldo Lpez, wrote a letter last week to Maduro, urging the Venezuelan leader to open a humanitarian channel to allow civil society groups to bring medical supplies into the country.

You can open a humanitarian channel that will enable international aid to reach those who most need it, Tintori said during a press conference. This is something that will help Venezuelans, and is separate from politics.

Venezuela's President Nicolas Maduro speaks during a meeting at the National Electoral Council (CNE) where he presented his proposal to set up a National Constituent Assembly, in Caracas, Venezuela May 3, 2017. (REUTERS/Marco Bello)

Home to the worlds largest oil reserves, Venezuela was for decades an economic leader in the western hemisphere and, despite a massive gap between rich and poor, was a major destination for neighboring Colombians and other Latin Americans fleeing their less prosperous and more troubled homelands.

But in 1999 with the rise to power of late leader Hugo Chvez whose social and economic reforms initially endeared him to the poor but also set up an unsustainable system of state spending Venezuelas economy began to creep toward a crisis.

The situation has been exacerbated by Maduro, Chvezs successor, who took power in 2013, and by a plunge in global oil prices in 2015.

A widespread protest movement in cities across the country against the Maduro regime has entered its third month and claimed more than 60 lives amid a violent government crackdown.

Reno told Fox News that her organization has at the moment halted its medical supply shipments to Venezuela as they dont want the goods ending up in Venezuelan government hands.

We are not going to be able to send anymore boxes until something happens, she said.

The something she is referring to is the July election that will choose the 545 delegates to a special convention charged with rewriting Chavez's 1999 constitution. Reno said that if pro-government forces win the bulk of the delegates, she will have to stop sending supplies altogether.

I am going to quit because it takes too much money and time to be giving supplies to have them taken by those thieves, she added.

A masked protester holds a placard that reads in Spanish: "Liberty" during clashes with government security forces in Caracas, Venezuela, Saturday, May 20, 2017. (AP Photo/Ariana Cubillos)

Prospects that things will improve in July arent looking good. Last Friday was the deadline for candidates to register for the July election, but the opposition has all but ruled out participating in what it considers a ploy by officials to avoid elections the government would surely lose. The U.S. and several foreign governments have also condemned the proposal for a new charter as anti-democratic.

"Any participation in this process is an act of complicity with the constitutional fraud and whoever partakes will be declared a cohort of the fraud, coup, repression and assassination of Venezuelans who have fallen in the peaceful protests for the sole reason they were exercising their legitimate right to demonstrate," the opposition Democratic Unity alliance said in a statement this week.

Polls taken before the protests kicked off this spring show that around 80 percent of Venezuelans favored Maduro's removal this year. Experts contend that if the opposition was to compete and win the election, or even come close in polling and gain the support of a growing number of disaffected government supporters, it would have an almost unfettered hand to remove Maduro and purge the courts and other institutions stacked with loyalists.

"I think the opposition is making a big mistake," Francisco Rodriguez, chief economist at New York-based Torino Capital, who helped mediate Vatican-sponsored talks last year between the opposition and government, told The Associated Press. "The only way you can win an election with 20 percent support is getting your opponent to not participate, which is essentially what's happening."

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Venezuela blocking medicine, humanitarian aid from US groups - Fox News

ProHealth Care has been selected to be the provider of sport medicine services to Carroll Universitys student athletes, faculty, coaches and staff.

ProHealth Care is expected to serve more than 550 student athletes, faculty and staff members, including those involved in 22 NCAA Division III teams, under a new exclusive agreement with the university.

The ProHealth services will help us continue to compete at the highest level possible and ensure that our athletes remain at the top of their game, said Joe Baker, director of intercollegiate athletics at Carroll University.

ProHealth will provide sports medicine physicians, physical therapists and athletic trainers who will help Carroll athletes and prevent sports injuries. They also will provide initial treatment for athletic injuries, as well as rehabilitation and reconditioning services for injured athletes.

Their expertise and services made sense for us to pursue this contract with ProHealth for the foreseeable future, said Michael Schulist, assistant athletics director for media relations, operations and marketing at Carroll University. They will provide therapy and health care services to our student athletes, which is a huge boost to the area. It will give our student athletes a lot of extra attention for minor injuries and recommending surgery if needed based off of ProHealth Cares experience.

Previously, the university contracted with Aurora Health Care for its sports medicine services.

Providing these services to Carroll University is a natural extension of our sports medicine program, said Julie Jackson, ProHealth Cares vice president of operations. Our team is highly trained in multi-level care that includes prevention, diagnosis, emergency care and rehabilitation of injuries and medical conditions.

ProHealth provides sports medicine services to St. Johns Northwestern Military Academy in Delafield, as well as a host of high schools in Waukesha County.

ProHealth Care has been selected to be the provider of sport medicine services to Carroll Universitys student athletes, faculty, coaches and staff.

ProHealth Care is expected to serve more than 550 student athletes, faculty and staff members, including those involved in 22 NCAA Division III teams, under a new exclusive agreement with the university.

The ProHealth services will help us continue to compete at the highest level possible and ensure that our athletes remain at the top of their game, said Joe Baker, director of intercollegiate athletics at Carroll University.

ProHealth will provide sports medicine physicians, physical therapists and athletic trainers who will help Carroll athletes and prevent sports injuries. They also will provide initial treatment for athletic injuries, as well as rehabilitation and reconditioning services for injured athletes.

Their expertise and services made sense for us to pursue this contract with ProHealth for the foreseeable future, said Michael Schulist, assistant athletics director for media relations, operations and marketing at Carroll University. They will provide therapy and health care services to our student athletes, which is a huge boost to the area. It will give our student athletes a lot of extra attention for minor injuries and recommending surgery if needed based off of ProHealth Cares experience.

Previously, the university contracted with Aurora Health Care for its sports medicine services.

Providing these services to Carroll University is a natural extension of our sports medicine program, said Julie Jackson, ProHealth Cares vice president of operations. Our team is highly trained in multi-level care that includes prevention, diagnosis, emergency care and rehabilitation of injuries and medical conditions.

ProHealth provides sports medicine services to St. Johns Northwestern Military Academy in Delafield, as well as a host of high schools in Waukesha County.

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ProHealth Care to provide sports medicine services at Carroll University - BizTimes.com (Milwaukee)

WHITE SULPHUR SPRINGS, W.Va. The Greenbrier and WVUMedicine announced Monday they have entered a partnership for medical care delivery for the resorts athletic events and training camps.

According to a news release, a WVU Medicine sports medicine physician will be on site during all athletic events. This includes The Greenbrier Classic, which is scheduled for July 3 though July 9.

In addition, anyone requiring specialty care will be transported to J.W. Ruby Memorial Hospital in Morgantown.

Two great organizations are combining resources to ensure the professional athletes involved in sporting events at The Greenbrier have access to excellent medical services, said David Darden, administrator of the Greenbrier Clinic. The affiliation with WVU Medicines Sports Medicine program affords us the opportunity to continue the delivery of excellence at The Greenbrier.

When people visit The Greenbrier, they expect the best, and the same is true of those who seek out WVU Medicine for their medical care, said Albert Wright, president and CEO of the WVU Medicine-West Virginia University Health System. We are honored to have been chosen as The Greenbriers exclusive medical provider, and we look forward to growing this relationship long into the future.

Dr. Brenden Balcik, a WVU Medicine emergency medicine and sports medicine physician, was also announced as medical director for the July golf tournament.

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Greenbrier, WVU Medicine announce partnership - West Virginia MetroNews