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Archive for the ‘Voices of Patients and Healthcare Providers’ Category

#TUBiol5227: Biomarkers & Biotargets: Genetic Testing and Bioethics

Curator: Stephen J. Williams, Ph.D.

The advent of direct to consumer (DTC) genetic testing and the resultant rapid increase in its popularity as well as companies offering such services has created some urgent and unique bioethical challenges surrounding this niche in the marketplace. At first, most DTC companies like 23andMe and Ancestry.com offered non-clinical or non-FDA approved genetic testing as a way for consumers to draw casual inferences from their DNA sequence and existence of known genes that are linked to disease risk, or to get a glimpse of their familial background. However, many issues arose, including legal, privacy, medical, and bioethical issues. Below are some articles which will explain and discuss many of these problems associated with the DTC genetic testing market as well as some alternatives which may exist.

‘Direct-to-Consumer (DTC) Genetic Testing Market to hit USD 2.5 Bn by 2024’ by Global Market Insights

This post has the following link to the market analysis of the DTC market (https://www.gminsights.com/pressrelease/direct-to-consumer-dtc-genetic-testing-market). Below is the highlights of the report.

As you can see,this market segment appears to want to expand into the nutritional consulting business as well as targeted biomarkers for specific diseases.

Rising incidence of genetic disorders across the globe will augment the market growth

Increasing prevalence of genetic disorders will propel the demand for direct-to-consumer genetic testing and will augment industry growth over the projected timeline. Increasing cases of genetic diseases such as breast cancer, achondroplasia, colorectal cancer and other diseases have elevated the need for cost-effective and efficient genetic testing avenues in the healthcare market.
 

For instance, according to the World Cancer Research Fund (WCRF), in 2018, over 2 million new cases of cancer were diagnosed across the globe. Also, breast cancer is stated as the second most commonly occurring cancer. Availability of superior quality and advanced direct-to-consumer genetic testing has drastically reduced the mortality rates in people suffering from cancer by providing vigilant surveillance data even before the onset of the disease. Hence, the aforementioned factors will propel the direct-to-consumer genetic testing market overt the forecast timeline.
 

DTC Genetic Testing Market By Technology

Get more details on this report – Request Free Sample PDF
 

Nutrigenomic Testing will provide robust market growth

The nutrigenomic testing segment was valued over USD 220 million market value in 2019 and its market will witness a tremendous growth over 2020-2028. The growth of the market segment is attributed to increasing research activities related to nutritional aspects. Moreover, obesity is another major factor that will boost the demand for direct-to-consumer genetic testing market.
 

Nutrigenomics testing enables professionals to recommend nutritional guidance and personalized diet to obese people and help them to keep their weight under control while maintaining a healthy lifestyle. Hence, above mentioned factors are anticipated to augment the demand and adoption rate of direct-to-consumer genetic testing through 2028.
 

Browse key industry insights spread across 161 pages with 126 market data tables & 10 figures & charts from the report, “Direct-To-Consumer Genetic Testing Market Size By Test Type (Carrier Testing, Predictive Testing, Ancestry & Relationship Testing, Nutrigenomics Testing), By Distribution Channel (Online Platforms, Over-the-Counter), By Technology (Targeted Analysis, Single Nucleotide Polymorphism (SNP) Chips, Whole Genome Sequencing (WGS)), Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2020 – 2028” in detail along with the table of contents:
https://www.gminsights.com/industry-analysis/direct-to-consumer-dtc-genetic-testing-market
 

Targeted analysis techniques will drive the market growth over the foreseeable future

Based on technology, the DTC genetic testing market is segmented into whole genome sequencing (WGS), targeted analysis, and single nucleotide polymorphism (SNP) chips. The targeted analysis market segment is projected to witness around 12% CAGR over the forecast period. The segmental growth is attributed to the recent advancements in genetic testing methods that has revolutionized the detection and characterization of genetic codes.
 

Targeted analysis is mainly utilized to determine any defects in genes that are responsible for a disorder or a disease. Also, growing demand for personalized medicine amongst the population suffering from genetic diseases will boost the demand for targeted analysis technology. As the technology is relatively cheaper, it is highly preferred method used in direct-to-consumer genetic testing procedures. These advantages of targeted analysis are expected to enhance the market growth over the foreseeable future.
 

Over-the-counter segment will experience a notable growth over the forecast period

The over-the-counter distribution channel is projected to witness around 11% CAGR through 2028. The segmental growth is attributed to the ease in purchasing a test kit for the consumers living in rural areas of developing countries. Consumers prefer over-the-counter distribution channel as they are directly examined by regulatory agencies making it safer to use, thereby driving the market growth over the forecast timeline.
 

Favorable regulations provide lucrative growth opportunities for direct-to-consumer genetic testing

Europe direct-to-consumer genetic testing market held around 26% share in 2019 and was valued at around USD 290 million. The regional growth is due to elevated government spending on healthcare to provide easy access to genetic testing avenues. Furthermore, European regulatory bodies are working on improving the regulations set on the direct-to-consumer genetic testing methods. Hence, the above-mentioned factors will play significant role in the market growth.
 

Focus of market players on introducing innovative direct-to-consumer genetic testing devices will offer several growth opportunities

Few of the eminent players operating in direct-to-consumer genetic testing market share include Ancestry, Color Genomics, Living DNA, Mapmygenome, Easy DNA, FamilytreeDNA (Gene By Gene), Full Genome Corporation, Helix OpCo LLC, Identigene, Karmagenes, MyHeritage, Pathway genomics, Genesis Healthcare, and 23andMe. These market players have undertaken various business strategies to enhance their financial stability and help them evolve as leading companies in the direct-to-consumer genetic testing industry.
 

For example, in November 2018, Helix launched a new genetic testing product, DNA discovery kit, that allows customer to delve into their ancestry. This development expanded the firm’s product portfolio, thereby propelling industry growth in the market.

The following posts discuss bioethical issues related to genetic testing and personalized medicine from a clinicians and scientisit’s perspective

Question: Each of these articles discusses certain bioethical issues although focuses on personalized medicine and treatment. Given your understanding of the robust process involved in validating clinical biomarkers and the current state of the DTC market, how could DTC testing results misinform patients and create mistrust in the physician-patient relationship?

Personalized Medicine, Omics, and Health Disparities in Cancer:  Can Personalized Medicine Help Reduce the Disparity Problem?

Diversity and Health Disparity Issues Need to be Addressed for GWAS and Precision Medicine Studies

Genomics & Ethics: DNA Fragments are Products of Nature or Patentable Genes?

The following posts discuss the bioethical concerns of genetic testing from a patient’s perspective:

Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org

Ethical Concerns in Personalized Medicine: BRCA1/2 Testing in Minors and Communication of Breast Cancer Risk

23andMe Product can be obtained for Free from a new app called Genes for Good: UMich’s Facebook-based Genomics Project

Question: If you are developing a targeted treatment with a companion diagnostic, what bioethical concerns would you address during the drug development process to ensure fair, equitable and ethical treatment of all patients, in trials as well as post market?

Articles on Genetic Testing, Companion Diagnostics and Regulatory Mechanisms

Centers for Medicare & Medicaid Services announced that the federal healthcare program will cover the costs of cancer gene tests that have been approved by the Food and Drug Administration

Real Time Coverage @BIOConvention #BIO2019: Genome Editing and Regulatory Harmonization: Progress and Challenges

New York Times vs. Personalized Medicine? PMC President: Times’ Critique of Streamlined Regulatory Approval for Personalized Treatments ‘Ignores Promising Implications’ of Field

Live Conference Coverage @Medcitynews Converge 2018 Philadelphia: Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Question: What type of regulatory concerns should one have during the drug development process in regards to use of biomarker testing? From the last article on Protecting Your IP how important is it, as a drug developer, to involve all payers during the drug development process?

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This AI Just Evolved From Companion Robot To Home-Based Physician Helper

Reporter: Ethan Coomber, Research Assistant III, Data Science and Podcast Library Development 

Article Author: Gil Press Senior Contributor Enterprise & Cloud @Forbes 

Twitter: @GilPress I write about technology, entrepreneurs and innovation.

Intuition Robotics announced today that it is expanding its mission of improving the lives of older adults to include enhancing their interactions with their physicians. The Israeli startup has developed the AI-based, award-winning proactive social robot ElliQ which has spent over 30,000 days in older adults’ homes over the past two years. Now ElliQ will help increase patient engagement while offering primary care providers continuous actionable data and insights for early detection and intervention.

The very big challenge Intuition Robotics set up to solve was to “understand how to create a relationship between a human and a machine,” says co-founder and CEO Dor Skuler. Unlike a number of unsuccessful high-profile social robots (e.g., Pepper) that tried to perform multiple functions in multiple settings, ElliQ has focused exclusively on older adults living alone. Understanding empathy and how to grow a trusting relationship were the key objectives of Intuition Robotics’ research project, as well as how to continuously learn the specific (and changing) behavioral characteristics, habits, and preferences of the older adults participating in the experiment.

The results are impressive: 90% of users engage with ElliQ every day, without deterioration in engagement over time. When ElliQ proactively initiates deep conversational interactions with its users, there’s 70% response rate. Most important, the participants share something personal with ElliQ almost every day. “She has picked up my attitude… she’s figured me out,” says Deanna Dezern, an ElliQ user who describes her robot companion as “my sister from another mother.”

The very big challenge Intuition Robotics set up to solve was to “understand how to create a relationship between a human and a machine,” says co-founder and CEO Dor Skuler. Unlike a number of unsuccessful high-profile social robots (e.g., Pepper) that tried to perform multiple functions in multiple settings, ElliQ has focused exclusively on older adults living alone. Understanding empathy and how to grow a trusting relationship were the key objectives of Intuition Robotics’ research project, as well as how to continuously learn the specific (and changing) behavioral characteristics, habits, and preferences of the older adults participating in the experiment.

The results are impressive: 90% of users engage with ElliQ every day, without deterioration in engagement over time. When ElliQ proactively initiates deep conversational interactions with its users, there’s 70% response rate. Most important, the participants share something personal with ElliQ almost every day. “She has picked up my attitude… she’s figured me out,” says Deanna Dezern, an ElliQ user who describes her robot companion as “my sister from another mother.”

Higher patient engagement leads to lower costs of delivering care and the quality of the physician-patient relationship is positively associated with improved functional health, studies have found. Typically, however, primary care physicians see their patients anywhere from once a month to once a year, even though about 85% of seniors in the U.S. have at least one chronic health condition. ElliQ, with the consent of its users, can provide data on the status of patients in between office visits and facilitate timely and consistent communications between physicians and their patients.

Supporting the notion of a home-based physician assistant robot is the transformation of healthcare delivery in the U.S. More and more primary care physicians are moving from a fee-for-service business model, where doctors are paid according to the procedures used to treat a patient, to “capitation,” where doctors are paid a set amount for each patient they see. This shift in how doctors are compensated is gaining momentum as a key solution for reducing the skyrocketing costs of healthcare: “…inadequate, unnecessary, uncoordinated, and inefficient care and suboptimal business processes eat up at least 35%—and maybe over 50%—of the more than $3 trillion that the country spends annually on health care. That suggests more than $1 trillion is being squandered,” states “The Case for Capitation,” a Harvard Business Review article.

Under this new business model, physicians have a strong incentive to reduce or eliminate visits to the ER and hospitalization, so ElliQ’s assistance in early intervention and support of proactive and preventative healthcare is highly valuable. ElliQ’s “new capabilities provide physicians with visibility into the patient’s condition at home while allowing seamless communication… can assist me and my team in early detection and mitigation of health issues, and it increases patients’ involvement in their care through more frequent engagement and communication,” says in a statement Dr. Peter Barker of Family Doctors, a Mass General Brigham-affiliated practice in Swampscott, MA, that is working with Intuition Robotics.

With the new stage in its evolution, ElliQ becomes “a conversational agent for self-reported data on how people are doing based on what the doctor is telling us to look for and, at the same time, a super-simple communication channel between the physician and the patient,” says Skuler. As only 20% of the individual’s health has to do with the administration of healthcare, Skuler says the balance is already taken care of by ElliQ—encouraging exercise, watching nutrition, keeping mentally active, connecting to the outside world, and promoting a sense of purpose.

A recent article in The Communication of the ACM pointed out that “usability concerns have for too long overshadowed questions about the usefulness and acceptability of digital technologies for older adults.” Specifically, the authors challenge the long-held assumption that accessibility and aging research “fall under the same umbrella despite the fact that aging is neither an illness nor a disability.”

For Skuler, a “pyramid of value” is represented in Intuition Robotics offering. At the foundation is the physical product, easy to use and operate and doing what it is expected to do. Then there is the layer of “building relationships based on trust and empathy,” with a lot of humor and social interaction and activities for the users. On top are specific areas of value to older adults, and the first one is healthcare. There will be more in the future, anything that could help older adults live better lives, such as direct connections to the local community. ”Healthcare is an interesting experiment and I’m very much looking forward to see what else the future holds for ElliQ,” says Skuler.

Original. Reposted with permission, 7/7/2021.

Other related articles published in this Open Access Online Scientific Journal include the Following:

The Future of Speech-Based Human-Computer Interaction
Reporter: Ethan Coomber
https://pharmaceuticalintelligence.com/2021/06/23/the-future-of-speech-based-human-computer-interaction/

Deep Medicine: How Artificial Intelligence Can Make Health Care Human Again
Reporter: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2020/11/11/deep-medicine-how-artificial-intelligence-can-make-health-care-human-again/

Supporting the elderly: A caring robot with ‘emotions’ and memory
Reporter: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2015/02/10/supporting-the-elderly-a-caring-robot-with-emotions-and-memory/

Developing Deep Learning Models (DL) for Classifying Emotions through Brainwaves
Reporter: Abhisar Anand, Research Assistant I
https://pharmaceuticalintelligence.com/2021/06/22/developing-deep-learning-models-dl-for-classifying-emotions-through-brainwaves/

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Project Patient Voice

Reporter: Gail S. Thornton, M.A.

 

September 7, 2020

 

Project Patient Voice is an online platform for patients and caregivers along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials.

Trial Name Disease Type Drug Study Design Blinding Status Comparator Arm Patient Questionnaire Used to Collect Symptom Data FDA Label
AURA3 Advanced non-small cell lung cancer with EGFR mutation TAGRISSO Randomized Open label Platinum-based doublet chemotherapy PRO-CTCAE Here

SOURCE

https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice

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2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

Front line caregivers have combined passion and innovation throughout the crisis, saving lives and bringing lasting change across the care continuum.

Nurses and other caregivers will share how patients were helped and future care was defined – acute, post-acute, rehab and home care – through real time innovations.

Moderator

Ann Prestipino

SVP and Incident Commander, MGH

PANELISTS

Theresa Gallivan, RN

Associate Chief Nurse, MGH

Karen Reilly, DNP, RN

Associate Chief Nursing Officer, Critical Care, Cardiovascular and Surgical Services, BH

Ross Zafonte, DO

SVP, Research Education and Medical Affairs, SRN; Earle P. and Ida S. Charlton Professor of Physical Medicine and Rehabilitation, HMS

VIEW VIDEOS from the event

https://www.youtube.com/channel/UCauKpbsS_hUqQaPp8EVGYOg

From: “Coburn, Christopher Mark” <CMCOBURN@PARTNERS.ORG>

Date: Tuesday, May 12, 2020 at 6:48 AM

To: “Coburn, Christopher Mark” <CMCOBURN@PARTNERS.ORG>

Subject: REGISTRANT RECAP | World Medical Innovation Forum  

 

Dear World Forum Attendee, 

On behalf of Mass General Brigham CEO Anne Klibanski MD and Forum co-Chairs Gregg Meyer MD and Ravi Thadhani MD, many thanks for being among the nearly 11,000 registrants representing 93 countries, 46 states and 3200 organizations yesterday. A community was established around many pressing topics that  will continue long into the future. We hope you have a chance to examine the attached survey results. There are several revealing items that should be the basis for ongoing discussion. We expect to be in touch regularly during the year. Among the plans is a “First Look” video series highlighting top Mass General Brigham Harvard faculty as well as emerging Harvard investigators.  As promised, we  wanted to also share visual Forum session summaries.  You will be able to access the recordings on the Forum’s YouTube page . The first set will go up this morning

We hope you will join us for the 2021 Forum!  

Thanks again, Chris

e-Proceedings 2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

https://pharmaceuticalintelligence.com/2020/04/22/world-medical-innovation-forum-covid-19-ai-and-the-future-of-medicine-featuring-harvard-and-industry-leader-insights-mgh-bwh-virtual-event-monday-may-11-815-a-m-515-p-m-et/

Tweets & Retweets 2020 World Medical Innovation Forum – COVID-19, AI and the Future of Medicine, Featuring Harvard and Industry Leader Insights – MGH & BWH, Virtual Event: Monday, May 11, 8:15 a.m. – 5:15 p.m. ET

https://pharmaceuticalintelligence.com/2020/05/11/tweets-retweets-2020-world-medical-innovation-forum-covid-19-ai-and-the-future-of-medicine-featuring-harvard-and-industry-leader-insights-mgh-bwh-virtual-event-mond/

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SID ISRAEL Panel 31 March 2020 Covid 19 outbreak in the Developing world

LIVE Coverage & Reporter’s Perspective: Ofer Markman, PhD

 

As an umbrella organization we feel obliged to take action in the outbreak of the COVID-19 in the developing world. In order to address if and how the Israeli and Jewish aid community should act and understand the needs of the developing world. The agenda included a short review from executives in international organizations, leading institutions in the developing world, and various civil society and business representatives in Israel who are active in the developing world The webinar was moderated by
  • Dr Bruria Adini- head of the Department of Emergency Management and Disaster Medicine in the Tel Aviv University

 

Was listening to SID Israel preparatory information session on COVID-19 preparations for developing countries from March 31, which is centuries ago in the development of this crisis.

Reminder Europe was in a crisis, the USA and the UK were showing a sign they will join but not have quiet caught up.

WATCH VIDEO

 

with historical perspectives a first world – developing world perspective is no longer relevant in many ways. Some of the issues that were raised in way the “first” world was reacting to the shock the situation has caused the European nations were affecting smaller nations within Europe already; yet the intensity of the situation and the speed this crisis is developing has not allowed us to free our minds to understand it.

While Europe has suffered dramatically, and Spain, Italy and France are at the heat of the pandemics Europe has not come to it as a unified community/country and the outcome of which are already staggering, The “brutal fight” for protective gear and all kind of panic based measures taken by countries such as Germany, have caused havoc in countries in Europe that are mostly dependent on neighbor countries for their supplies in what looked like the open borders of Europe.

The evidence for this is not in cries from these countries but in the numbers: San Marino is the country with the highest death and illness rates (per Million) in Europe, 5-20 times the numbers of surrounding Italy, and So is Andorra, Luxembourg, Gibraltar, Monaco and even Liechtenstein, be it masks, tests or other measures that where missing, be it sanitation, disinfection or missing food essentials that depended on neighboring countries the outcomes are still outrageous.

Outside of this there are major challenges that developing countries are facing in some of the paradigms regardless of the major impacts of border closures, flight restrictions, custom restrictions and general crisis based regulation and bureaucratic hurdles added to normal limitations of working over borders

Some issues raised were issues of cultural and economical differences but to many of those the solutions are those that were already worked before: collaboration on community level across organizations and aid sectors, exchange of information, and working with local leadership

the panel was in a way on putting borders between humanity and virus and not between us human.

It was meant as a brain-storm and not a lecture.

The rep of WHO Europe HQ in Denmark shared their sometimes frustration over border limits and human/supply movement amid urgent need as well as the price war between countries and organizations.

But had pride in their success in putting together efforts and using long term relations to overcome and set up regional labs as preparatory measure.

Covid-19 is a challenge since it so far hit the hardest in Europe and the USA the epicenters of humanitarian aid and understanding that there is a “we are all in it together” takes a bigger perspectives (e.g. we have to dea with covid 19 in prisons and detention centers, refugee camps and other “off the map” places even in the US-Mexico borders, across war borders and in communities of great marginalization.

Yet often a small effort can make miracles, an advice on who to talk to and who to work with on a school, religion, community leadership can be more important then a box of gloves.

Another issue is the balance of disease mitigation in a community with zero margins on the hunger front, with a hard balance on the sanitation issues nad the innability to inflict stricter clossure on the camps that are already suffering form over closures to the brink of disaster.

I recommend listening albeit long discussion, you may skip the first ten mins intro if short in time.

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From @Harvardmed Center for Bioethics: The Medical Ethics of the Corona Virus Crisis

Reporter: Stephen J. Williams, Ph.D.

From Harvard Medical School Center for Bioethics

source: https://bioethics.hms.harvard.edu/news/medical-ethics-corona-virus-crisis

The Medical Ethics of the Corona Virus Crisis

Executive Director Christine Mitchell discusses the importance of institutions talking through the implications of their decisions with the New Yorker.

Center Executive Director Christine Mitchell spoke with the New Yorker’s Isaac Chotiner about the decisions that may need to be made on limiting movement and, potentially, rationing supplies and hospital space.

“So, in the debate about allocating resources in a pandemic, we have to work with our colleagues around what kind of space is going to be made available—which means that other people and other services have to be dislocated—what kind of supplies we’re going to have, whether we’re going to reuse them, how we will reallocate staff, whether we can have staff who are not specialists take care of patients because we have way more patients than the number of specialized staff,” says Mitchell.

Read the full Q&A in the New Yorker.

 

Note: The following is taken from the Interview in the New Yorker.

As the novel coronaviruscovid-19, spreads across the globe, governments have been taking increasingly severe measures to limit the virus’s infection rate. China, where it originated, has instituted quarantines in areas with a large number of cases, and Italy—which is now facing perhaps the most serious threat outside of China—is entirely under quarantine. In the United States, the National Guard has been deployed to manage a “containment area” in New Rochelle, New York, where one of the country’s largest clusters has emerged. As the number of cases rises, we will soon face decisions on limiting movement and, potentially, rationing supplies and hospital space. These issues will be decided at the highest level by politicians, but they are often influenced by medical ethicists, who advise governments and other institutions about the way to handle medical emergencies.

One of those ethicists, with whom I recently spoke by phone, is Christine Mitchell, the executive director at the Center for Bioethics at Harvard Medical School. Mitchell, who has master’s degrees in nursing and philosophical and religious ethics, has been a clinical ethicist for thirty years. She founded the ethics program at Boston Children’s Hospital, and has served on national and international medical-ethics commissions. During our conversation, which has been edited for length and clarity, we discussed what ethicists tend to focus on during a health crisis, how existing health-care access affects crisis response, and the importance of institutions talking through the ethical implications of their decisions.

What coronavirus-related issue has most occupied your mental space over the past weeks?

One of the things I think about but that we don’t often have an opportunity to talk about, when we are mostly focussing on what clinicians are doing and trying to prepare for, is the more general ways this affects our society. People get sick out there in the real world, and then they come to our hospitals, but, when they are sick, a whole bunch of them don’t have health insurance, or are afraid to come to a hospital, or they don’t have coverage for sick time or taking a day off when their child is sick, so they send their child to school. So these all have very significant influences on our ability to manage population health and community transmission that aren’t things that nurses and physicians and people who work in acute-care hospitals and clinics can really affect. They are elements of the way our society is structured and has failed to meet the needs of our general population, and they influence our ability to manage a crisis like this.

Is there anything specifically about a pandemic or something like coronavirus that makes these issues especially acute?

If a person doesn’t have health insurance and doesn’t come to be tested or treated, and if they don’t have sick-time coverage and can’t leave work, so they teach at a school, or they work at a restaurant, or do events that have large numbers of people, these are all ways in which the spread of a virus like this has to be managed—and yet can’t be managed effectively because of our social-welfare policies, not just our health-care resources.

Just to take a step back, and I want to get back to coronavirus stuff, but what got you interested in medical ethics?

What got me interested were the actual kinds of problems that came up when I was taking care of patients, starting as early as when I was in nursing school and was taking care of a patient who, as a teen-ager, had a terminal kind of cancer that his parents didn’t want him to know about, and which the health-care team had decided to defer to the parents. And yet I was spending every day taking care of him, and he was really puzzled about why he was so sick and whether he was going to get better, and so forth. And so of course I was faced with this question of, What do I do if he asks me? Which, of course, he did.

And this question about what you should tell an adolescent and whether the deference should be to his parents’ judgment about what’s best for him, which we would ordinarily respect, and the moral demands of the relationship that you have with a patient, was one of the cases that reminded me that there’s a lot more to being a nurse or a health-care provider than just knowing how to give cancer chemotherapy and change a bed, or change a dressing, or whatever. That a lot of it is in the relationship you have with a patient and the kinds of ethical choices they and their families are facing. They need your information, but also your help as they think things through. That’s the kind of thing that got me interested in it. There are a whole host of those kinds of cases, but they’re more individual cases.

As I began to work in a hospital as an ethicist, I began to worry about the broader organizational issues, like emergency preparedness. Some years ago, here in Boston, I had a joint appointment running the ethics program at Children’s Hospital and doing clinical ethics at Harvard Medical School. We pulled together a group, with the Department of Public Health and the emergency-preparedness clinicians in the Harvard-affiliated hospitals, to look at what the response within the state of Massachusetts should be to big, major disasters or rolling pandemics, and worked on some guidelines together.

When you looked at the response of our government, in a place like Washington State or in New York City, what things, from a medical-ethics perspective, are you noticing that are either good or maybe not so good?

To be candid and, probably, to use language that’s too sharp for publication, I’m appalled. We didn’t get ourselves ready. We’ve had outbreaks—sars in 2003, H1N1 in 2009, Ebola in 2013, Zika in 2016. We’ve known, and the general population in some ways has known. They even have movies like “Contagion” that did a great job of sharing publicly what this is like, although it is fictional, and that we were going to have these kinds of infectious diseases in a global community that we have to be prepared to handle. And we didn’t get ourselves as ready, in most cases, as we should have. There have been all these cuts to the C.D.C. budget, and the person who was the Ebola czar no longer exists in the new Administration.

And it’s not just this Administration. But the thing about this Administration that perhaps worries me the most is a fundamental lack of respect for science and the facts. Managing the crisis from a public-relations perspective and an economic, Dow Jones perspective are important, but they shouldn’t be fudging the facts. And that’s the piece that makes me feel most concerned—and not just as an ethicist. And then, of course, I want to see public education and information that’s forthright and helps people get the treatment that they need. But the disrespect for the public, and not providing honest information, is . . . yeah, that’s pretty disconcerting.

SOURCE

https://www.newyorker.com/news/q-and-a/the-medical-ethics-of-the-coronavirus-crisis

See more on this and #COVID19 on this Online Open Access Journal at our Coronavirus Portal at

https://pharmaceuticalintelligence.com/coronavirus-portal/

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Responses to the #COVID-19 outbreak from Oncologists, Cancer Societies and the NCI: Important information for cancer patients

Curator: Stephen J. Williams, Ph.D.

UPDATED 3/20/2020

Among the people who are identified at risk of coronovirus 2019 infection and complications of the virus include cancer patients undergoing chemotherapy, who in general, can be immunosuppressed, especially while patients are undergoing their treatment.  This has created anxiety among many cancer patients as well as their care givers and prompted many oncologist professional groups, cancer societies, and cancer centers to formulate some sort of guidelines for both the cancer patients and the oncology professional with respect to limiting the risk of infection to coronavirus (COVID19). 

 

This information will be periodically updated and we are working to get a Live Twitter Feed to bring oncologist and cancer patient advocacy groups together so up to date information can be communicated rapidly.  Please see this page regularly for updates as new information is curated.

IN ADDITION, I will curate a listing of drugs with adverse events of immunosuppression for people who might wonder if the medications they are taking are raising their risk of infections.

Please also see @pharma_BI for updates as well.

Please also see our Coronavirus Portal at https://pharmaceuticalintelligence.com/coronavirus-portal/

For ease of reading information for patients are BOLDED and in RED

ASCO’s Response to COVID-19

From the Cancer Letter: The following is a guest editorial by American Society of Clinical Oncology (ASCO) Executive Vice President and Chief Medical Officer Richard L. Schilsky MD, FACP, FSCT, FASCO. This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

 

The worldwide spread of the coronavirus (COVID-19) presents unprecedented challenges to the cancer care delivery system.

Our patients are already dealing with a life-threatening illness and are particularly vulnerable to this viral infection, which can be even more deadly for them. Further, as restrictions in daily movement and social distancing take hold, vulnerable patients may be disconnected from friends, family or other support they need as they manage their cancer.

As providers, we rely on evidence and experience when treating patients but now we face uncertainty. There are limited data to guide us in the specific management of cancer patients confronting COVID-19 and, at present, we have no population-level guidance regarding acceptable or appropriate adjustments of treatment and practice operations that both ensure the best outcome for our patients and protect the safety of our colleagues and staff.

As normal life is dramatically changed, we are all feeling anxious about the extreme economic challenges we face, but these issues are perhaps even more difficult for our patients, many of whom are now facing interruption

As we confront this extraordinary situation, the health and safety of members, staff, and individuals with cancer—in fact, the entire cancer community—is ASCO’s highest priority.

ASCO has been actively monitoring and responding to the pandemic to ensure that accurate information is readily available to clinicians and their patients. Recognizing that this is a rapidly evolving situation and that limited oncology-specific, evidence-based information is available, we are committed to sharing what is known and acknowledging what is unknown so that the most informed decisions can be made.

To help guide oncology professionals as they deal with the impact of coronavirus on both their patients and staff, ASCO has collated questions from its members, posted responses at asco.org and assembled a compendium of additional resources we hope will be helpful as the virus spreads and the disease unfolds. We continue to receive additional questions regarding clinical care and we are updating our FAQs on a regular basis.

We hope this information is helpful even when it merely confirms that there are no certain answers to many questions. Our answers are based on the best available information we identify in the literature, guidance from public health authorities, and input received from oncology and infectious disease experts.

For patients, we have posted a blog by Dr. Merry Jennifer Markham, chair of ASCO’s Cancer Communications Committee. This can be found on Cancer.Net, ASCO’s patient information website, and it provides practical guidance to help patients reduce their risk of exposure, better understand COVID-19 symptoms, and locate additional information.

This blog is available both in English and Spanish. Additional blog posts addressing patient questions will be posted as new questions are received and new information becomes available.

Find below a Tweet from Dr.Markham which includes links to her article on COVID-19 for cancer patients

https://twitter.com/DrMarkham/status/1237797251038220289?s=20

NCCN’s Response to COVID-19 and COVID-19 Resources

JNCCN: How to Manage Cancer Care during COVID-19 Pandemic

Experts from the Seattle Cancer Care Alliance (SCCA)—a Member Institution of the National Comprehensive Cancer Network® (NCCN®)—are sharing insights and advice on how to continue providing optimal cancer care during the novel coronavirus (COVID-19) pandemic. SCCA includes the Fred Hutchinson Cancer Research Center and the University of Washington, which are located in the epicenter of the COVID-19 outbreak in the United States. The peer-reviewed article sharing best practices is available for free online-ahead-of-print via open access at JNCCN.org.

Coronavirus disease 2019 (COVID-19) Resources for the Cancer Care Community

NCCN recognizes the rapidly changing medical information relating to COVID-19 in the oncology ecosystem, but understands that a forum for sharing best practices and specific institutional responses may be helpful to others.  Therefore, we are expeditiously providing documents and recommendations developed by NCCN Member Institutions or Guideline Panels as resources for oncology care providers. These resources have not been developed or reviewed by the standard NCCN processes, and are provided for information purposes only. We will post more resources as they become available so check back for additional updates.

Documents

Links

National Cancer Institute Response to COVID-19

More information at https://www.cancer.gov/contact/emergency-preparedness/coronavirus

What people with cancer should know: https://www.cancer.gov/coronavirus

Get the latest public health information from CDC: https://www.coronavirus.gov

Get the latest research information from NIH: https://www.nih.gov/coronavirus

 

Coronavirus: What People with Cancer Should Know

ON THIS PAGE

Both the resources at cancer.gov (NCI) as well as the resources from ASCO are updated as new information is evaluated and more guidelines are formulated by members of the oncologist and cancer care community and are excellent resources for those living with cancer, and also those who either care for cancer patients or their family and relatives.

Related Resources for Patients (please click on links)

 

 

 

Some resources and information for cancer patients from Twitter

Twitter feeds which may be useful sources of discussion and for cancer patients include:

 

@OncLive OncLive.com includes healthcare information for patients and includes videos and newsletters

 

 

@DrMarkham Dr. Markham is Chief of Heme-Onc & gyn med onc @UF | AD Med Affairs @UFHealthCancer and has collected very good information for patients concerning #Covid19 

 

 

@DrMaurieMarkman Dr. Maurie Markman is President of Medicine and Science (Cancer Centers of America, Philadelphia) @CancerCenter #TreatThePerson #Oncology #Genomics #PrecisionMedicine and hosts a great online live Tweet feed discussing current topics in cancer treatment and care for patients called #TreatThePerson Chat

UPDATED 3/20/2020 INFORMATION FROM NCI DESIGNATED CANCER CENTERS FOR PATIENTS/PROVIDERS

The following is a listing with links of NCI Designated Comprehensive Cancer Centers and some select designated Cancer Centers* which have information on infectious risk guidance for cancer patients as well as their physicians and caregivers.   There are 51 NCI Comprehensive Cancer Centers and as more cancer centers formulate guidance this list will be updated. 

 

Cancer Center State Link to COVID19 guidance
City of Hope CA Advice for cancer patients, survivors and caregivers
Jonsson Cancer Center at UCLA CA Cancer and COVID19
UCSF Hellen Diller Family Comprehensive Cancer CA COVID-19 Links for Patients and Providers
Lee Moffit FL Protecting against Coronavirus 19
University of Kansas Cancer Center* KS COVID19 Info for patients
Barbara & Karmanos Cancer Institute (Wayne State) MI COVID19 Resources
Rogel Cancer Center (Univ of Michigan) MI COVID19 Patient Specific Guidelines
Alvin J. Siteman Cancer Center (MO) Coronavirus
Fred & Pamela Buffet CC* NE Resources for Patients and Providers
Rutgers Cancer Institute of NJ NJ What patients should know about COVID19
Memorial Sloan Kettering NY What COVID19 means for cancer patients
Herbert Irving CC (Columbia University) NY Coronavirus Resource Center
MD Anderson Cancer  TX Planning for Patients, Providers
Hunstman Cancer Center UT COVID19 What you need to know
Fred Hutchinson WA COVID19 What patients need to know

 

 

Please also see related information on Coronavirus 2019 and Cancer and Immunotherapy at the following links on the Open Access Online Journal:

Volume Two: Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery 

at

https://pharmaceuticalintelligence.com/biomed-e-books/series-c-e-books-on-cancer-oncology/volume-two-immunotherapy-in-cancer-radiation-oncology/

AND

Coronavirus Portal

 

 

 

 

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Reporter: Gail S. Thornton, M.A.

This article is excerpted from the Harvard Business Review, May 28, 2019

By Moni Miyashita, Michael Brady

3.4.13   The Health Care Benefits of Combining Wearables and AI, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 3: AI in Medicine

In southeast England, patients discharged from a group of hospitals serving 500,000 people are being fitted with a Wi-Fi-enabled armband that remotely monitors vital signs such as respiratory rate, oxygen levels, pulse, blood pressure, and body temperature.

Under a National Health Service pilot program that now incorporates artificial intelligence to analyze all that patient data in real time, hospital readmission rates are down, and emergency room visits have been reduced. What’s more, the need for costly home visits has dropped by 22%. Longer term, adherence to treatment plans have increased to 96%, compared to the industry average of 50%.

The AI pilot is targeting what Harvard Business School Professor and Innosight co-founder Clay Christensen calls “non-consumption.”  These are opportunity areas where consumers have a job to be done that isn’t currently addressed by an affordable or convenient solution.

Before the U.K. pilot at the Dartford and Gravesham hospitals, for instance, home monitoring had involved dispatching hospital staffers to drive up to 90 minutes round-trip to check in with patients in their homes about once per week. But with algorithms now constantly searching for warning signs in the data and alerting both patients and professionals instantly, a new capability is born: providing healthcare before you knew you even need it.

The biggest promise of artificial intelligence — accurate predictions at near-zero marginal cost — has rightly generated substantial interest in applying AI to nearly every area of healthcare. But not every application of AI in healthcare is equally well-suited to benefit. Moreover, very few applications serve as an appropriate strategic response to the largest problems facing nearly every health system: decentralization and margin pressure.

Take for example, medical imaging AI tools — an area in which hospitals are projected to spend $2 billion annually within four years. Accurately diagnosing diseases from cancers to cataracts is a complex task, with difficult-to-quantify but typically major consequences. However, the task is currently typically part of larger workflows performed by extensively trained, highly specialized physicians who are among some of the world’s best minds. These doctors might need help at the margins, but this is a job already being done. Such factors make disease diagnosis an extraordinarily difficult area for AI to create transformative change. And so the application of AI in such settings  —  even if beneficial  to patient outcomes —  is unlikely to fundamentally improve the way healthcare is delivered or to substantially lower costs in the near-term.

However, leading organizations seeking to decentralize care can deploy AI to do things that have never been done before. For example: There’s a wide array of non-acute health decisions that consumers make daily. These decisions do not warrant the attention of a skilled clinician but ultimately play a large role in determining patient’s health — and ultimately the cost of healthcare.

According to the World Health Organization, 60% of related factors to individual health and quality of life are correlated to lifestyle choices, including taking prescriptions such as blood-pressure medications correctly, getting exercise, and reducing stress. Aided by AI-driven models, it is now possible to provide patients with interventions and reminders throughout this day-to-day process based on changes to the patient’s vital signs.

Home health monitoring itself isn’t new. Active programs and pilot studies are underway through leading institutions ranging from Partners Healthcare, United Healthcare, and the Johns Hopkins School of Medicine, with positive results. But those efforts have yet to harness AI to make better judgements and recommendations in real time. Because of the massive volumes of data involved, machine learning algorithms are particularly well suited to scaling that task for large populations. After all, large sets of data are what power AI by making those algorithms smarter.

By deploying AI, for instance, the NHS program is not only able to scale up in the U.K. but also internationally. Current Health, the venture-capital backed maker of the patient monitoring devices used in the program, recently received FDA clearance to pilot the system in the U.S. and is now testing it with New York’s Mount Sinai Hospital. It’s part of an effort to reduce patient readmissions, which costs U.S. hospitals about $40 billion annually.

The early success of such efforts drives home three lessons in using AI to address non-consumption in the new world of patient-centric healthcare:

1) Focus on impacting critical metrics – for example, reducing costly hospital readmission rates.

Start small to home in on the goal of making an impact on a key metric tied to both patient outcomes and financial sustainability. As in the U.K. pilot, this can be done through a program with select hospitals or provider locations. In another case Grady Hospital, the largest public hospital in Atlanta, points to $4M in saving from reduced readmission rates by 31% over two years thanks to the adoption of an AI tool which identifies ‘at-risk’ patients. The system alerts clinical teams to initiate special patient touch points and interventions.

2) Reduce risk by relying on new kinds of partners.

Don’t try to do everything alone. Instead, form alliances with partners that are aiming to tackle similar problems. Consider the Synaptic Healthcare Alliance, a collaborative pilot program between Aetna, Ascension, Humana, Optum, and others. The alliance is using Blockchain to create a giant dataset across various health care providers, with AI trials on the data getting underway. The aim is to streamline health care provider data management with the goal of reducing the cost of processing claims while also improving access to care. Going it alone can be risky due to data incompatibility issues alone. For instance, the M.D. Anderson Cancer Center had to write off millions in costs for a failed AI project due in part to incompatibility with its electronic health records system. By joining forces, Synaptic’s dataset will be in a standard format that makes records and results transportable.

3) Use AI to collaborate, not compete, with highly-trained professionals.

Clinicians are often looking to augment their knowledge and reasoning, and AI can help. Many medical AI applications do actually compete with doctors. In radiology, for instance, some algorithms have performed image-bases diagnosis as well as or better than human experts. Yet it’s unclear if patients and medical institutions will trust AI to automate that job entirely. A University of California at San Diego pilot in which AI successfully diagnosed childhood diseases more accurately than junior-level pediatricians still required senior doctors to personally review and sign off on the diagnosis. The real aim is always going to be to use AI to collaborate with clinicians seeking higher precision — not try to replace them.

MIT and MGH have developed a deep learning model which identifies patients likely to develop breast cancer in the future. Learning from data on 60,000 prior patients, the AI system allows physicians to personalize their approach to breast cancer screening, essentially creating a detailed risk profile for each patient.

Taken together, these three lessons paired with solutions targeted at non-consumption have the potential to provide a clear path to effectively harnessing a technology that has been subject to rampant over-promising. Longer term, we believe the one of the transformative benefits of AI will be deepening relationships between health providers and patients. The U.K. pilot, for instance, is resulting in more frequent proactive check-ins that never would have happened before. That’s good for both improving health as well as customer loyalty in the emerging consumer-centric healthcare marketplace.

Source:

https://hbr.org/2019/05/the-health-care-benefits-of-combining-wearables-and-ai

 

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Novel delivery system in REMfresh mimics the way the body naturally releases and maintains melatonin over a 7-hour period

Real-world evidence confirms previous clinical data on improved sleep duration and sleep quality with REMfresh

Reporter: Gail S. Thornton, M.A.

Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States.[i] The cumulative long term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression.[ii]In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes.[iii]

This month, real-world evidence from two recently completed patient-reported outcomes (PRO) studies presented at SLEEP 2019 in San Antonio, Texas, confirms previous clinical data demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality with REMfresh®, the first and only continuous release and absorption melatonin (CRA-Melatonin™). This data supports and reinforces the benefits of REMfresh, which is designed to give patients up to 7 hours of sleep support. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies.

The REMfresh Duration Validation (REMVAL) study provides further evidence of a correlative relationship between the 7-hour pharmacokinetic profile observed in the earlier clinical study, REM Absorption Kinetics Trial (REMAKT), and the hypnotic effects of REMfresh, observed in subsequent studies, as demonstrated by improvements in sleep onset, sleep duration, sleep maintenance, sleep quality and patient satisfaction. This latest study further validates the findings of past studies that have been presented and undergone peer review at major sleep conferences:  

  • REMfresh Patient Reported Outcomes DURation (REMDUR), the first, 500-patient, PRO study of this sleep brand, presented at the annual meeting for sleep specialists, SLEEP 2018, which demonstrated that more than 77 percent of patients achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh (p<.0001)[iv], and
  • REM Absorption Kinetics Trial (REMAKT), a pharmacokinetic study presented at SLEEP 2017 and 2018, which demonstrated that REMfresh mimics the body’s own seven-hour Mesa-Wave® release profile, a natural pattern of melatonin blood levels during a normal night’s sleep cycle.[v] 

An additional PRO subset study, part of REMVAL, called the REMfresh Short Sleep Cohort Assessment (REMSS), assessed improvements in sleep duration and sleep maintenance among 311 patients with morbid or extreme short sleep duration of 4 hours or less.

These two PRO studies (REMVAL and REMSS) were presented at SLEEP 2019, the 33rd Annual Meeting of the Associated Professional Sleep Societies (APSS), which is a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held in San Antonio, Texas, from June 8-12.

“These latest findings provide further confirmation of the potential for nonprescription REMfresh to help address the public health issue of  the cumulative effects of sleep loss,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery as well as Sleep Medicine, Founder and Principle Physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Florida, and Senior Medical Advisor for Physician’s Seal, LLC. “Based on a novel Ion Powered Pump® (IPP®) delivery system that provides a pharmacokinetic (PK) profile that more closely aligns with the body’s own natural sleep pattern, REMfresh has demonstrated once again promising results and high levels of satisfaction in a real-world population of patients who have had chronic difficulties sleeping, providing up to seven hours of sleep support,” said Dr. Brodner.

Topline findings of these studies are as follows:

  • The 1,116 patient-reported outcomes (PRO) study, REMfresh Duration Validation (REMVAL), found that after taking 99 percent ultra-pure, continuous release and absorption melatonin (REMfresh®, CRA-melatonin™), the majority (78.8 percent) of patients involved achieved a sleep duration of greater than or equal to 6 hours (p<.0001), while more than 91 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001).  Of the 30.7 percent of patients (342 in total), who reported never having taken other brands of melatonin, 99.4 percent indicated they were likely or very likely to continue taking CRA-melatonin for their sleep issues (p<.0001).
  • REMVAL provides further real-world evidence of a correlative relationship between the originally observed 7-hour pharmacokinetic profile in the REM Absorption Kinetics Trial (REMAKT) and the strong observed hypnotic effects of CRA-melatonin, as demonstrated by improvements in sleep onset, sleep duration, sleep maintenance and sleep quality.
  • A second PRO subset study, REMfresh Short Sleep Cohort Assessment (REMSS), involving 311 patients who reported sleeping four hours or less nightly from the REMVAL study, found that 95.8 percent of patients who previously experienced daily, morbid short sleep duration of less than or equal to 4 hours reported an improvement in sleep duration (p<.0001), including more than 46 percent who achieved a sleep duration of greater than or equal to 6 hours (p<.0001). More than 93 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001).
  • REMVAL and REMSS also provides validation of the results from the previously peer-reviewed and presented clinical study, REMAKT, which demonstrated that REMfresh mimics the body’s own 7-hour Mesa Wave®, a natural pattern of melatonin blood levels during a normal night’s sleep cycle and the 500-patient, peer-reviewed and presented  REMfresh® Patient Reported Outcomes DURation (REMDUR) study, that demonstrated statistically significant improvements in sleep onset, sleep maintenance and sleep quality.

REMVAL Study Describes Improvements in Sleep Duration and Sleep Quality

The poster entitled, “Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality,” reported findings provides further real-world evidence of a correlative relationship between the originally observed 7-hour pharmacokinetic profile in the REM Absorption Kinetics Trial (REMAKT) and the strong hypnotic effects of CRA-melatonin observed in subsequent studies and may offer a new low-dose, drug-free alternative to prescription hypnotics to treat chronic sleep disturbances.

The 1,116-patient REMVAL study was designed to obtain clinically relevant information about patients’ past usage of melatonin and non-melatonin sleep aids, sleep patterns prior to taking CRA-melatonin, sleep duration before and after taking CRA-melatonin, frequency of CRA-melatonin usage, improvement in sleep onset, sleep maintenance and sleep quality after taking CRA-melatonin, and overall satisfaction with CRA-melatonin.

In the study, patients with sleep disturbances in the general population received a sample of REMfresh from their physicians and were invited to complete a 13-question online survey. After taking REMfresh, the majority (78.8 percent) of patients achieved a sleep duration of greater than or equal to 6 hours (p<.0001). More than 91 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Of the 30.7 percent of patients (342 in total), who reported never having taken other brands of melatonin, 99.4 percent indicated they were likely or very likely to continue taking REMfresh for their sleep issues (p<.0001).

REMSS Study Shows Improvement in Patients with Chronic, Extreme Short Sleep

The poster entitled, “Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study,” highlighted findings from the REMfresh Short Sleep Cohort Assessment (REMSS), involving a cohort of 311 patients from the REMVAL study who reported sleeping four hours or less nightly. This cohort analysis was designed to obtain clinically relevant information from these patients experiencing morbid short sleep disturbances, including sleep patterns and melatonin usage before taking REMfresh, sleep duration before and after taking REMfresh, improvement in sleep onset, sleep maintenance and sleep quality after taking REMfresh, and overall product satisfaction.

Data from this cohort show that 95.8 percent of patients who previously experienced daily, morbid short sleep duration of less than or equal to 4 hours reported an improvement in sleep duration (p<.0001), including more than 46 percent who achieved a sleep duration of greater than or equal to 6 hours (p<.0001). This increase from less than or equal to 4 hours to greater than or equal to 6 hours represents a major sleep duration upgrade in this group facing morbid sleep disturbances. More than 93 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Ninety-nine percent of the patients suffering with morbid short sleep (27.2 percent of whom had never previously tried a melatonin brand) reported that they were very likely or likely to continue using CRA-melatonin. These results provide real-world evidence that CRA-melatonin with its extended 7-hour pharmacokinetic  plateau time and benign safety-profile may be a practical baseline therapy to improve sleep duration and other key sleep parameters, including, sleep maintenance and sleep quality in this group of patients who have a higher risk of all-cause mortality.[vi]˒[vii]˒[viii]˒[ix]

Statistics & Data Corporation (SDC), a top-tier clinical data services provider, has independently determined that the number of participants in the study provides adequate power (>90%) to detect even small improvements in sleep outcomes. This high power, or probability of seeing statistically significant results if CRA-melatonin is truly working to improve sleep outcomes, applies to the overall study population (REMVAL) as well as the cohort of short sleepers (REMSS). SDC has subsequently independently validated the statistical results achieved, (e.g., p-values and statistical language).

The Increasing Appreciation of PRO Studies to Include Patient Experience 
Increasingly, there is an appreciation by the U.S. Congress, regulatory authorities and academia, of the substantive value that real-world patient experience brings to assessing new therapies. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient’s response by health-care intermediaries. PRO measures can be used to capture a patient’s everyday experience outside of the clinician’s office, and the effects of a treatment on the patient’s activities of daily living.[x]˒[xi]Together, clinical measures and PRO measures can provide a fuller picture of patient benefit.

REMAKT Clinical Study Presented at Past Medical Meetings 
Pharmacokinetic data on REMfresh® was peer-reviewed and then presented in 2017 and 2018 at SLEEP, the Annual Meeting of the Associated Professional Sleep Societies LLC (APSS), and a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). 

The study, REM Absorption Kinetics Trial (REMAKT), was a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin). The study found that melatonin levels with REMfresh exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the market-leading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and then had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours. 

Analysis presented at SLEEP 2017 and 2018 showed that REMfresh builds upon the body of evidence from prolonged-release melatonin (PR-M), approved by the European Medicines Agency (EMA) in 2007 as a prescription drug for insomnia, which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep onset and quality of life in patients aged 55 years and older compared with placebo.[xv] REMfresh was designed to overcome the challenges of continuous release and absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave®, a flat-topped hill with steep sides).[xvi] There was the desirable fast time to reach the sleep threshold level, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave may help to improve sleep maintenance and morning alertness. 

Over 5,000 healthcare practitioners are estimated to have used REMfresh for their patients and about 320,000 patients are estimated to have purchased and used REMfresh. The continuing, rapid acceptance of REMfresh by patients is observable by several markers, including rapid sales growth and availability among major drug retailers.

###

Data Presented at SLEEP 2019 Poster Sessions:

Monday, June 10, 2019, 5:15-7:15pm

  • (Abstract 0398, Poster Board #135) Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study
    • David J. Seiden, M.D., FAASM,  David Brodner, M.D., Syed M. Shah, Ph.D.
  • (Abstract 0399, Poster Board #136) Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality
    • David J. Brodner, M.D., David J. Seiden, M.D. FAASM, Syed M. Shah, Ph.D.

The abstracts are published in an online supplement of the journal, Sleep, which is available at https://sleepmeeting.org/wp-content/uploads/2019/04/SLEEP_42_S1-Website-Final.pdf.

REFERENCES:


[i] Colten, H.R., & Altevogt, B.M. (Eds). (2006). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). doi: https://doi.org/10.17226/11617

[ii] Cappuccio, F.P., D’Elia, L., Strazzullo, P., & Miller, M.A. (2010). Sleep duration and all-cause mortality: A systemic review and meta-analysis of prospective studies. Sleep, 33(5):585-592.

[iii] Watson, N.F., Badr, M.S., Belenky, G., et al. (2015). Joint Consensus Statement of the American Academy of Sleep  Medicine and Sleep Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(6); 591-592.

[iv] Seiden,D.J., Brodner, D.C., & Shah, S.M. (2018, June 2-6). Improvement in Sleep Maintenance and Sleep Quality with Ion-Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study (Abstract #0419). Poster presented at SLEEP 2018, Baltimore, Maryland.

[v] Brodner, D.C., Shah, S.M. (2017, June 3-7). REM Absorption Kinetics Trial: A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation versus a Same Strength Immediate-Release Formulation in Healthy Adults (Abstract #0396). Poster presented at: SLEEP 2017, Boston, Massachusetts.

[vi] Knutsen, K.L., Turek,, F.W., Patel, S.R., et al (2006). The u-shaped association between sleep and health: the 2 peaks do not mean the same thing.  Comment on Patel, SR, et al. Sleep, 29(7): 878-879.

[vii] Lubetkin,, E.I., & Haomiao, J. (2018). Burden of disease due to sleep duration and sleep problems in the elderly. Sleep Health, 4; 182-187.

[viii] Hafner M, et al. (2017). Why sleep matters-the economic costs of insufficient sleep: A cross-country comparative analysis, Rand Quarterly.

[ix] Ikehara, S, et al. (2009). Association of Sleep Duration with Mortality  from Cardiovascular Disease and other Causes for Japanese Men and Women: the JACC Study. Sleep, 32(3); 295-301.

[x] U.S. Food and Drug Administration. Real World Evidence. Retrieved from https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm

[xi] U.S. Food and Drug Administration. 21st Century Cures Act. Retrieved from https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm.

[xii] Colten, H.R., & Altevogt, B.M. (Eds). (2006). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). doi: https://doi.org/10.17226/11617

[xiii] Cappuccio, F.P., D’Elia, L., Strazzullo, P., & Miller, M.A. (2010). Sleep duration and all-cause mortality: A systemic review and meta-analysis of prospective studies. Sleep, 33(5):585-592.

[xiv] Watson, N.F., Badr, M.S., Belenky, G., et al. (2015). Joint Consensus Statement of the American Academy of Sleep  Medicine and Sleep Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(6); 591-592.

[xv] European Medicines Agency.(2007). Assessment Report for CIRCADIN.

[xvi] Brodner, D.C. & Shah, S.M. (2017, June 3-7). A Continuous Release Ion Powered Pump Melatonin Delivery System that Overcomes Challenges of Release and Absorption in the Intestines (Abstract #0385). Poster presented at: SLEEP 2017,  Boston, Massachusetts.

SOURCES:

https://finance.yahoo.com/news/significant-real-world-evidence-confirms-123000247.html

Dr. David C. Brodner, Center for Sinus, Allergy, and Sleep Wellness (http://www.brodnermd.com/sleep-hygiene.html)

Other related articles published in this Open Access Online Scientific Journal include the following:

2018

https://pharmaceuticalintelligence.com/2018/06/10/patient-reported-outcomes-study-presented-at-sleep-2018-provides-confirmatory-real-world-evidence-of-the-previously-presented-7-hour-action-of-remfresh-the-first-continuous-release-and-absorp/

2017

https://pharmaceuticalintelligence.com/2017/10/02/2017-nobel-prize-in-physiology-or-medicine-jointly-to-jeffrey-c-hall-michael-rosbash-and-michael-w-young-for-their-discoveries-of-molecular-mechanisms-controlling-the-circadian-rhythm/

https://pharmaceuticalintelligence.com/2017/06/11/ultra-pure-melatonin-product-helps-maintain-sleep-for-up-to-7-hours/

2016

https://pharmaceuticalintelligence.com/2016/03/16/sleep-science/

2013

https://pharmaceuticalintelligence.com/2013/03/09/melatonin-and-its-effect-on-acetylcholinesterase-activity-in-erythrocytes/

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Real Time Coverage @BIOConvention #BIO2019: Understanding the Voices of Patients: Unique Perspectives on Healthcare; June 4 11:00 AM

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Description

The role of the patient has evolved dramatically over the past decade. Not only are patients increasingly more involved in their healthcare decision making, they are also passionate advocates who work tirelessly to advance drug development research and development and secure a public policy environment that is patient-centric. Join a discussion with patient advocates as they discuss their journeys to diagnosis and their viewpoints on our healthcare system. They will share their perspectives on what it means to be a patient and how they are advocating in their own unique ways to achieve a common goal: bringing new treatments to patients.

Speakers
Christopher Anselmo: affected by MS but did not understand why he should be involved in a study at the time or share your story but he saw others who benefited from both of these and now is fervent patient advocate. Each patient is worth their weight in gold as needed for other patient support.  The why needs to be asked of oneself before go out to other patients or into new trials. Might not see through to end if don’t have that discussion of why doing this.
Eve Bukowski:  she had stomach aches, went to hospital, and diagnosed with constipation, but had stage III colon cancer.  She was campaigning for Hillary Clinton but then started to campaign for her life.  She wound up having multiple therapies and even many I/O trials.  Fighting cancer is a mental challenge.   She has been fighting for eleven years but has an amazing strength and will.
Emily Kramer: cystic fibrosis patient.  Advocates for research as she has a mutant allele (nonsense mut) that is not targeted by the current new therapy against known mutants of CFTR.  So started Emily’s Entourage for this orphan of an orphan disease.  Funded $4 million in grants and helped develop a new startup and get early seed funding.  Noticed that the infrastructure to get these drugs to market was broken and also is investing to shore up these breaks in drug pipeline infrastructure for orphan diseases. For progressive diseases she would like drug developers to shift the timelines or speed with which they get to take a chance and try that new possibility. As a patient advocacy org, they want to partner every step of the way with biotech/pharma, they understand co’s and stakeholders can only do so much but let’s break out of convention.
Julie: many patient advocacy groups go person to person and make a support network.

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

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