Public Health Issue: Epidemics, blame the Smartphone

I resisted buying a smartphone until about two years ago.  All my sons have had them for 10 years or more.  No they did not have them when they were three or four.  My eldest son bought an iPhone when he was 18.  ( I couldn't afford one, with 3 in college.

My first was a prepaid LG which was a month to month...These phones are all cheaply made, with poor screens, inadequate memory and other issues I do not fathom. I found one for $125 with a monthly fee of $45.00 The idea of having a contract appealed less to me than paying  $125 dollars or more for a 'bundled cable/internet/phone service.  

By now my brother had an iPhone, Macbook and iMac.  My son had traded up twice with his iPhone and also a Macbook. Two of my sons are computer scientists . I cautioned them about the technical of DUI (of smartphones).I doubt they listen to me.  It is equivalent to having 2 or 3 alcoholic drinks or having an open bottle in the car.

Suggestions for safer us of your smartphone



The smartphone has insidiously crept into our lives, much like antibiotic resistant bacteria. It can be found in our toilet areas, and other private spaces. No longer do hormonally gifted girls and boys flirt with a wink, they can do it electronically or even more boldly with suggestive photos. How does one use "protection" in such a situation?

Like any opiod it soothes and eases pain and eventually is an addiction. The temptation was too great   I caved, at first trying an iPhone....it was not so great !. I opted for the latest greatest most expensive Galaxy S8+.   Then I perseverated over cases and protectors.!  Another story and not worth explaining here to my entrapped audience.

Along with my own opinions I found several articles written about the subject. Andrew Doan, M.D., PhD in neuroscience and fellow ophthalmologist has done research into video game and internet addiction, discussing the role of endorphin release in users of videogames and the like.

Associated literature (from PubMed)

Tendon rupture associated with excessive smartphone gaming.

Gilman L1, Cage DN2, Horn A1, Bishop F3, Klam WP4, Doan AP5.

Author information

Abstract

IMPORTANCE:

Excessive use of smartphones has been associated with injuries.

OBSERVATIONS:

A 29-year-old, right hand-dominant man presented with chronic left thumb pain and loss of active motion from playing a Match-3 puzzle video game on his smartphone all day for 6 to 8 weeks. On physical examination, the left extensor pollicis longus tendon was not palpable, and no tendon motion was noted with wrist tenodesis. The thumb metacarpophalangeal range of motion was 10° to 80°, and thumb interphalangeal range of motion was 30° to 70°. The clinical diagnosis was rupture of the left extensor pollicis longus tendon. The patient subsequently underwent an extensor indicis proprius (1 of 2 tendons that extend the index finger) to extensor pollicis longus tendon transfer. During surgery, rupture of the extensor pollicis longus tendon was seen between the metacarpophalangeal and wrist joints.

CONCLUSIONS AND RELEVANCE:

The potential for video games to reduce pain perception raises clinical and social considerations about excessive use, abuse, and addiction. Future research should consider whether pain reduction is a reason some individuals play video games excessively, manifest addiction, or sustain injuries associated with video gaming.

Is Internet Pornography Causing Sexual Dysfunctions? A Review with Clinical Reports.

Park BY1, Wilson G2, Berger J3, Christman M4, Reina B5, Bishop F6, Klam WP7, Doan AP8,9.

Author information

Abstract

Traditional factors that once explained men's sexual difficulties appear insufficient to account for the sharp rise in erectile dysfunction, delayed ejaculation, decreased sexual satisfaction, and diminished libido during partnered sex in men under 40. This review (1) considers data from multiple domains, e.g., clinical, biological (addiction/urology), psychological (sexual conditioning), sociological; and (2) presents a series of clinical reports, all with the aim of proposing a possible direction for future research of this phenomenon. Alterations to the brain's motivational system are explored as a possible etiology underlying pornography-related sexual dysfunctions. This review also considers evidence that Internet pornography's unique properties (limitless novelty, potential for easy escalation to more extreme material, video format, etc.) may be potent enough to condition sexual arousal to aspects of Internet pornography use that do not readily transition to real-life partners, such that sex with desired partners may not register as meeting expectations and arousal declines. Clinical reports suggest that terminating Internet pornography use is sometimes sufficient to reverse negative effects, underscoring the need for extensive investigation using methodologies that have subjects remove the variable of Internet pornography use. In the interim, a simple diagnostic protocol for assessing patients with porn-induced sexual dysfunction is put forth.

Excessive Video Game Use, Sleep Deprivation, and Poor Work Performance Among U.S. Marines Treated in a Military Mental Health Clinic: A Case Series.

Eickhoff E1, Yung K1, Davis DL1, Bishop F2, Klam WP1, Doan AP1.

Author information

Abstract

Excessive use of video games may be associated with sleep deprivation, resulting in poor job performance and atypical mood disorders. Three active duty service members in the U.S. Marine Corps were offered mental health evaluation for sleep disturbance and symptoms of blunted affect, low mood, poor concentration, inability to focus, irritability, and drowsiness. All three patients reported insomnia as their primary complaint. When asked about online video games and sleep hygiene practices, all three patients reported playing video games from 30 hours to more than 60 hours per week in addition to maintaining a 40-hour or more workweek. Our patients endorsed sacrificing sleep to maintain their video gaming schedules without insight into the subsequent sleep deprivation. During the initial interviews, they exhibited blunted affects and depressed moods, but appeared to be activated with enthusiasm and joy when discussing their video gaming with the clinical provider. Our article illustrates the importance of asking about online video gaming in patients presenting with sleep disturbances, poor work performance, and depressive symptoms. Because excessive video gaming is becoming more prevalent worldwide, military mental health providers should ask about video gaming when patients report problems with sleep.

The evidence is strong that persistent use of many types of electronic devices may be addictive and contributory to multiple disorders, even extending to traumatic injury.

Doctors Feel Excluded from Health Care Value Efforts

This is not a new problem.  It has been going on for more than a decade.  Physicians have been excluded from reform and even feel as if we are the "guinea pigs" for administrators to experiment upon.

U.S. hospitals and health care groups have experimented over the past decade with new management structures and alternative payment models to provide quality health care at lower cost. But physicians have been slow to embrace these for a host of reasons. Chief among them, our research shows, is that they feel excluded from the process.

The only practical way to make value-based care a reality is for health care organizations to bring physicians back into the decision-making process. After years of experimentation, doctors want evidence that new models for health care management, reimbursement, and policy will actually improve clinical outcomes for their patients. Without it, they see little reason to alter the status quo. That’s a fundamental and overlooked obstacle to progress. And it explains why management-led organizations that have not embraced physician input have run into resistance.

The Harvard Business Review 

by Tim van Biesen

Josh Weisbrod

With our colleagues at Bain & Company, we recently surveyed 980 U.S. physicians in eight specialties, 100 health system finance officers, as well as 100 health system procurement officers — the people in charge of buying supplies for hospitals. What we found was startling: Physicians clearly understand the challenge posed by rising costs for clinical care and prescription drugs, but many don’t feel they are in a position to help rein in costs. They do not feel sufficiently engaged in making important decisions about cost control, performance improvement, and adoption of new reimbursement models. Indeed, many feel overruled, with mandate after mandate from hospitals and management-led health organizations being done to them, not with them.

Steeped in a field that requires lifelong learning, many physicians are natural innovators and quick to test new systems and tools. But they staunchly resist new approaches that could put patient care at risk. That helps explain why management-led organizations that have not fully embraced physician input, for example, have run into resistance or have failed to make a greater impact. The US healthcare model remains firmly centered on physicians.

In fact, more than 60% of the physicians we surveyed believe it will become more difficult to deliver high-quality care in the next two years as they struggle to cope with a complex regulatory environment, increasing administrative burdens and a more difficult reimbursement landscape. After years of experimentation, physicians now want evidence that new models for care management, reimbursement, policy and patient engagement will actually improve clinical outcomes. 

Comparing our 2015 and 2017 survey findings, one notable slowdown has been in the adoption of value-based payment models. Many physicians anticipated a broad rollout of value-based care two years ago and a corresponding decline in practices using the traditional fee-for-service model. But few have been persuaded to switch, noting a lack of evidence that outcomes are the same or better using value-based care. More than 70% of physicians prefer to use a fee-for-service model, citing concerns about the complexity and quality of care associated with value-based payment models. Fifty-three percent of physicians say that capitation reduces the quality of care, and most see little advantage from pay-for-performance models either. Further, many believe their organizations are not sufficiently prepared for the shift to value-based care.

Despite the reluctance to drop fee-for-service payment systems, many organizations continue to experiment with value-based care as part of a mix of payment models, recognizing the continual pull in the industry toward the value-based approach. Providers that want to move toward value-based payment models can generate greater support by working closely with their physicians to shape these models and addressing their concerns about outcomes, simplicity and fairness to all stakeholders.

All of these issues impact greatly acquisition of medical devices, pharmacy benefits

Providers will have greater success at implementing change if they improve stakeholder alignment on cost-saving initiatives. Physicians need a clinical rationale for changing the way they deliver care—financial logic alone will not change long-established behaviors.

• The adoption of new healthcare structures, value-based models and tools to curb spiraling costs and improve care has slowed and in some cases plateaued following five years of rapid experimentation and change.
• Simply put, the system is struggling to adapt to the already set of reforms.

This chart demonstrates the disparity amongst providers as to preferred method(s) of reimbursement.

Value based payment is an undefined term, and many experts are struggling to define an algorithm measuring APMs and their benefits.

Physicians recognize that fee for service is more expensive than other models......but are concerned that the more advanced value-based models negatively affect the quality of care.

For more details: The Changing Landscape

Doctors Feel Excluded from Health Care Value Efforts

Positive Hospital Marketing Campaigns Have A Painful Downside : Shots - Health News : NPR

In today's health world, marketing has become a major influence. It must be since corporations always analyze their ROI based upon the uptick in their business.

Regulatory agencies seem to ignore blatant ethical violations and false advertising billboards, and 'branding' of their slogans. A large very successful health system whose brand is "THRIVE" will be instantly recognized without seeing it's name.

Physicians would be sanctioned by medical boards for this tactic, although some larger medical groups slip through the watching eyes of regulatory agencies.

Is the problem with the hospitals or regulatory agencies such as the JCAH Joint Commission for Accreditation of Hospitals.

Hospitals aren't held to standards at all. So a hospital can go out and say, 'This is where miracles happen. And here's Joe. Joe was about to die. And now Joe is going to live forever.'

"So a hospital can go out and say, 'This is where miracles happen. And here's Joe. Joe was about to die. And now Joe is going to live forever.' "

Lori Wallace is not going to live forever. Before cancer, she says, she would have been attracted to the messages of hope. But now, she says, she needs realism — acceptance of both the world's beauty and its harshness. She wrote an essay about that for the women in her breast cancer support group.

The essay is titled "F*** Silver Linings and Pink Ribbons." Wallace reads me the whole piece from start to finish. We are sitting at her kitchen table. Her son is nearby with his pet snake.

Toward the middle of the essay, Wallace writes, "My ovaries are gone, and without them my skin is aging at hyperspeed. I have hot flashes and cold flashes. My bones ache. My libido is shot and my vagina is a desert." The essay is open, funny and unflinching, just like Wallace.

She reads me the final paragraph: "I will try to be thankful for every laugh, hug and kiss, and other things, too. That is, if my chemo-brain allows me to remember."

"That's what I wrote," Wallace says. "That's what I wrote. Brutal honesty."

Positive Hospital Marketing Campaigns Have A Painful Downside : Shots - Health News : NPR

CMS Proposal for New Medicare Payment System Could Lead to Large Payment Variability for Specialists | Avalere Health

Upcoming Medicare payment changes could affect your care.

Through a series of complex new regulations physician specialists face severe reduction in reimbursments. The group includes ophthalmologists, rheumatologists and oncologists.

New analysis from Avalere finds that payments to certain physician specialists could increase or decrease by as much as 16% for their 2018 performance under the Merit-based Incentive Payment System (MIPS).

The adjustments could take effect if the Centers for Medicare & Medicaid Services (CMS) finalizes a proposal to change how payments to clinicians are calculated under MIPS. For most types of physicians, these payment adjustments would only range between +/- 5%, as provided for under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

The changes will be transparent for most patients.  The specialties most impacted are those which use designer antiinflammatory and/or those which decrease blood vessel growth to malignant tumors and age related macular degeneration (VEGF).  These drugs are covered under Part B of Medicare.

The drugs are a new class of therapeutics, and are expensive, also requiring continuing usage by patients. They are often used as a mainline or last resort treatment.

Avalere’s research finds certain types of specialists, including rheumatologists, oncologists, and ophthalmologists bill for more Part B drugs than their counterparts in primary-care focused specialties. As a result, Part B drugs represent a larger percentage of total billed Medicare allowed charges for these specialists. Under the CMS proposal, Avalere found that some specialists could see payment adjustments as high as +/-16% for MIPS performance year 2018 (see Figure 1).  


Under the CMS proposal, the magnitude of risk for certain types of specialists would continue to increase as the MIPS program reaches full implementation. In performance year 2020, the payment adjustments could reach as high as +/- 29% for rheumatologists and oncologists (see Figure 2).

If finalized, this policy would mark a significant shift in CMS’ approach to payment adjustments. Payment adjustments for the legacy programs that MIPS sought to replace, like the Physician Quality Reporting System and Meaningful Use, have applied only to Medicare physician fee schedule services and not to Part B drugs.

“Many specialists may not have an alternative to the MIPS track due to limited opportunities for specialists to join an Advanced Alternative Payment Model,” said Richard Kane, senior director at Avalere.

Influence of Pokémon Go on Physical Activity: Study and Implications | Althoff | Journal of Medical Internet Research

Physical activity helps people maintain a healthy weight and reduces the risk for several chronic diseases. Although this knowledge is widely recognized, adults and children in many countries around the world do not get recommended amounts of physical activity. Although many interventions are found to be ineffective at increasing physical activity or reaching inactive populations, there have been anecdotal reports of increased physical activity due to novel mobile games that embed game play in the physical world. The most recent and salient example of such a game is Pokémon Go, which has reportedly reached tens of millions of users in the United States and worldwide.

Objective: The objective of this study was to quantify the impact of Pokémon Go on physical activity.

Methods: We study the effect of Pokémon Go on physical activity through a combination of signals from large-scale corpora of wearable sensor data and search engine logs for 32,000 Microsoft Band users over a period of 3 months. Pokémon Go players are identified through search engine queries and physical activity is measured through accelerometers.

Results: We find that Pokémon Go leads to significant increases in physical activity over a period of 30 days, with particularly engaged users (ie, those making multiple search queries for details about game usage) increasing their activity by 1473 steps a day on average, a more than 25% increase compared with their prior activity level (P<.001). In the short time span of the study, we estimate that Pokémon Go has added a total of 144 billion steps to US physical activity. Furthermore, Pokémon Go has been able to increase physical activity across men and women of all ages, weight status, and prior activity levels showing this form of game leads to increases in physical activity with significant implications for public health. In particular, we find that Pokémon Go is able to reach low activity populations, whereas all 4 leading mobile health apps studied in this work largely draw from an already very active population.

Conclusions: Mobile apps combining game play with physical activity lead to substantial short-term activity increases and, in contrast to many existing interventions and mobile health apps, have the potential to reach activity-poor populations. Future studies are needed to investigate potential long-term effects of these applications.

JMIR-Influence of Pokémon Go on Physical Activity: Study and Implications | Althoff | Journal of Medical Internet Research

Literates or Illiterates? Investigating the eHealth Literacy of Users of Online Health Communities | Petrič | Journal of Medical Internet Research

Health 3.0

Electronic health (eHealth) literacy is an important skill that allows patients to navigate intelligibly through the vast, often misleading Web-based world. Although eHealth literacy has been investigated in general and specific demographic populations, it has not yet been analyzed on users of online health communities (OHCs). Evidence shows that OHCs are important Web 2.0 applications for patients for managing their health, but at the same time, warnings have been expressed regarding the quality and relevance of shared information. No studies exist that investigate levels of eHealth literacy among users of OHCs and differences in eHealth literacy between different types of users.

The study was based on a cross-sectional Web survey on a simple random sample of 15,000 registered users of the most popular general OHC in Slovenia. The final sample comprised 644 users of the studied OHC. An extended eHEALS (eHEALS-E) was tested with factor analytical procedures, whereas user types were identified with a hierarchical clustering algorithm. The research question was analyzed with analysis of variance (ANOVA) procedure and pairwise comparison tests.

Results: Factor analysis of the revised and extended eHEALS revealed six dimensions: awareness of sources, recognizing quality and meaning, understanding information, perceived efficiency, validating information, and being smart on the Net. The factor solution demonstrates a good fit to the data (root mean square error of approximation [RMSEA]=.059). The most developed dimension of eHEALS-E is awareness of different Internet sources (mean=3.98, standard deviation [SD]=0.61), whereas the least developed is understanding information (mean=3.11, SD=0.75). Clustering resulted in four user types: active help-seekers (48.3%, 311/644), lurkers (31.8%, 205/644), core relational users (16.9%, 109/644), and low-engaged users (3%, 19/644). Analysis of the research question showed statistically significant differences among user types across all six dimensions of eHEALS-E. Most notably, core relational users performed worse than lurkers on the validating information dimension (P=.01) and worse than active help-seekers on the being smart on the Net dimension (P=.05). Active help-seekers have the highest scores in all dimensions of the eHEALS-E, whereas low-engaged users have statistically significantly lower scores on all dimensions of the eHEALS-E in comparison with the other groups.

Conclusions: Those who are looking for advice and support in OHCs by making queries are well equipped with eHealth literacy skills to filter potential misinformation and detect bad advice. However, core relational users (who produce the most content in OHCs) have less-developed skills for cross-validating the information obtained and navigating successfully through the perils of the online world. Site managers should monitor their activity to avoid the spread of misinformation that might lead to unhealthy practices.

JMIR-Ill Literates or Illiterates? Investigating the eHealth Literacy of Users of Online Health Communities | Petrič | Journal of Medical Internet Research

Three Americans win Nobel Prize in Physiology - The Washington Post

Three Americans win Nobel Prize in Physiology - The Washington Post

The Evil Clinic Administrator Health 3.0 in Marana, Arizona?

An evil administrator (CEO Clint Kuntz of MHC Healthcare in Tucson, AZ) 

Watch and listen to Zubin Damania, MD (aka Zdogg MD) interview CEO Clint Kuntz of MCH Healthcare, Clint is the one without the suit.

An evil administrator (CEO Clint Kuntz of MHC Healthcare in Tucson, AZ) gives me a tour of his community health clinic…and we see the signs of Health 3.0 errrrywhere.

Primary care and pharmacy and dental and behavioral health and peds and docs and nurse practitioners and radiology techs and MAs and lab peeps all working together for the benefit of patients and each other. It’s time we highlighted the bright spots in medicine, and this is definitely one of them.

Health 3.0 in Marana, Arizona?

Scrap Graham-Cassidy health bill or plunge America and GOP into misery

CONGRESS is not abiding by the rules of legislating new law.

After sequential failures of developing a workable and stable health reform law, perhaps the problem is not health reform,  rather a systemic failure in the legislative process, or congress' flagrant disregard for a long standing set of rules.  The process is clearly dictated,

How our laws are made.

Perhaps the most important phase of the legislative process is the action by committees. The committees provide the most intensive consideration to a proposed measure as well as the forum where the public is given their opportunity to be heard. A tremendous volume of work, often overlooked by the public, is done by the Members in this phase. There are, at present, 20 standing committees in the House and 16 in the Senate as well as several select committees. In addition, there are four standing joint committees of the two Houses, with oversight responsibilities but no legislative jurisdiction. The House may also create select committees or task forces to study specific issues and report on them to the House. A task force may be established formally through a resolution passed by the House or informally through organization of interested Members by the House leadership.

In the Senate, introduced measures and House-passed measures are referred to the one committee of preponderant jurisdiction by the Parliamentarian on behalf of the Presiding Officer. By special or standing order, a measure may be referred to more than one committee in the Senate

One of the first actions taken by a committee is to seek the input of the relevant departments and agencies about a bill. Frequently, the bill is also submitted to the Government Accountability Office with a request for an official report of views on the necessity or desirability of enacting the bill into law. Normally, ample time is given for the submission of the reports and they are accorded serious consideration. However, these reports are not binding on the committee in determining whether or not to act favorably on the bill. Reports of the departments and agencies in the executive branch are submitted first to the Office of Management and Budget to determine whether they are consistent with the program of the President. Many committees adopt rules requiring referral of measures to the appropriate subcommittee unless the full committee votes to retain the measure at the full committee.

Public hearings are a major step in the process.

The current impasse is indicative of this disregard for the law making process. 

LATE BREAKING NEWS: 

No vote for Graham-Cassidy ACA repeal bill

Estimates from non-government agencies agreed that about 30 million people would probably lose coverage under Graham-Cassidy. The Congressional Budget Office released a preliminary report on Graham-Cassidy on Monday, finding it would result in millions losing coverage, particularly after 2020. The agency said a regular analysis would require several more weeks.

The healthcare industry was fiercely opposed to the proposal, including groups representing doctors, hospitals, payers and patients. All 50 state Medicaid directors also signed on to a letter slamming the bill, as did 36 current and former state insurance commissioners.

A few healthcare executives also took the unusual step of speaking out specifically against the plan. Cleveland Clinic CEO Toby Cosgrove said in a statement the bill would “threaten the financial viability of hospitals nationwide.” Kaiser Permanente CEO Bernard Tyson said Graham-Cassidy’s block funding would “erode coverage of needed medical services and pose major issues for state budgets.”

A variety of polls showed the public was not generally fond of the proposal either. At a Senate hearing Monday afternoon, hundreds of people protesting the bill stood in the hearing room and surrounding hallways chanting: “No cuts to Medicaid. Save our liberty.”

PERHAPS CONGRESS IS BEGINNING TO LISTEN TO THE RIGHT PEOPLE

Scrap Graham-Cassidy health bill or plunge America and GOP into misery

My Dario

If you use a smartphone, you can leave your glucometer at home.  The DARIO glucometer is a plugin blood glucose monitor which is used  in the same manner as a conventional glucometer.  Unfortunately it requires that"ouch" finger prick.

When combined with the app it will read out your blood glucose.  The DARIO is FDA approved . Users seem to find it a refreshing change to the daily monotony of finger sticks.  Since most of us carry a smartphone,you can ditch the glucometer..

To add an additional safety level, the Dario system is built with an emergency hypo alert feature. Once enabled on your smartphone, Dario will send a text message to up to four people with your blood glucose level plus a link to where you are using your smartphone’s GPS coordinates.  Hypoglycemia can result in loss of conciousness leaving a person disabled, and in a coma.

The DARIO software also provides a calorie counting tool. It comes with it's own ecosystem of accessories and the option to subscribe for disposable lancets and strips.

My Dario

Big Pharma shake up reveals how R&D is changing for mid level pipeline drug advances

Why are pharmaceuticals so expensive.  New drugs go through a treacherous path to the market place, not just in terms of biochemical science, but also in deep pocket financing.  Prior to their release on the market with approval by the FDA, enormous sums of capital must be available to do the science of development.

It is enough of a task that places pharmaceutical companies at financial risk.  These two articles are a slice of financial vehicles which permit research to proceed.

Lilly puts two-thirds of midphase cancer pipeline up for sale in major shake-up of R&D

Eli Lilly is seeking partners for two-thirds of its midphase oncology compounds. The Big Pharma wants to offload six phase 2 candidates to focus its R&D dollars on a clutch of early to midstage assets it thinks can become the new standard of care.

Lilly is prioritizing the development of seven candidates, although one—breast cancer drug abemaciclib—is already in front of the FDA. Two of the remaining six are in phase 2, while the rest are yet to get out of phase 1. The list includes a PD-L1 antibody and PI3K/mTOR dual inhibitor Lilly is developing for use in combinations. And the small-molecule Chk-1 inhibitor it picked up from Array BioPharma.

Lilly faced increasing demands for financing of several phase I, II, and III drugs forcing to seek additional funds or partners.  The decision to cull half of the cancer pipeline coincided with a setback for Lilly’s baricitinib. The Incyte-partnered rheumatoid arthritis drug was due to come to market this year. But a demand by FDA for another study to allay its concerns about the incidence of blood clots looks set to push back the timeline by 18 months or more. That bodes badly for Lilly.

Lilly lists 10 assets in its partnered pipeline, the same number as are in its top and second-tier priority pipelines. Three of the phase 1 partnered assets are already owned by third parties. But the remaining seven—including six in phase 2—are yet to be the subject of outlicensing deals.

The seven drugs seeking new homes are:

• Galunisertib, a small molecule inhibitor of TGF beta R1 kinase  
• Ralimetinib, a p38 MAP kinase inhibitor
• Emibetuzumab, a MET antibody
• A notch Inhibitor 
• A FGFR inhibitor 
• A CXCR4 peptide antagonist
• A FGFR-3 antibody-drug conjugate

The pace at which new classes of drugs often exceeds and causes pharmaceutical companies to shift and change priorities in mid-cycle of drug development.

The same can be said for medical device companies

LivaNova puts for sale sign on $250M cardiac rhythm unit

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively

LivaNova is exploring strategic options for its cardiac rhythm management (CRM) business. The medtech company decided to look to offload the $250 million-a-year pacemaker and defibrillator unit after concluding it no longer fits with its strategy.

CRM is one of three units at LivaNova, the others being cardiac surgery and neuromodulation, and last year accounted for about one-fifth of its sales. Products including high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers generated those sales. But while CRM is competitive in some niches, notably in Europe and Japan, LivaNova thinks its best option is to part ways with the business.

LivaNova itself is the product of a merger between Sorin and Cyberonics in 2015/

The decisions are multi-factorial:

“The CRM business franchise is a global business and strong regional player with attractive assets, a robust pipeline and growth potential,” LivaNova CEO Damien McDonald said in a statement. “However, it is no longer a strategic fit within LivaNova’s portfolio.” “The single biggest decision and discussion point for us around capital allocation is how we create shareholder value with the CRM portfolio. It's top of mind for the leadership team, and we're continuing to work on that,”  CRM sales fell 6% over the first six months of 2017. LivaNova attributed the decline to a dropoff in sales of implantable cardiac defibrillators as compared to a period in which it introduced a new product, as well as unfavorable foreign currency exchange rate fluctuations.

State regulations create obstacles for telemedicine

Telehealth offers significant gains in accessibility for patients who live in . remote areas without access to primary care and/or sspecialty care.  Despite these advantages regulations differ in each state.  Health care reform in the ACA and future iteratioins has given insurance coverage to millions of more Americans. Coverage however does not guarrantee access to a physician.

Some adaptations already include the addition of nurse practitioners who are licensed to work independently. Their training is now standardized and many practice in a physician supervised clnic. However some work in rural and remote locations, requiring communication with a physician. Telemedicine offers the ability to share images, diagnostic images from otoscopes, ophthalmoscopes, and dermatology images, even with magnification. An ongoing interactive session adds to the NPs knowledge for a particular case.  Remote imaging is widely used for screening of diabetic retinopathy.

State regulators and state medical boards who advise legislators have uppermost in mind the efficacy, reliablity and safety of this technology.   Medical boards have already prescribed courses and limitations in guidelines for using telemedicine.  These are easily found elsewhere in the guidelines form the American Telemedicine Association.

The Federation of State Medical Boards (FSMB) Chair, Jon V. Thomas, MD, MBA, appointed the State Medical Boards’ Appropriate Regulation of Telemedicine (SMART) Workgroup to review the “Model Guidelines for the Appropriate Use of the Internet in Medical Practice” (HOD 2002)1 and other existing FSMB policies on telemedicine and to offer recommendations to state medical and osteopathic boards (hereinafter referred to as “medical boards” and/or “boards”) based on a thorough review of recent advances in technology and the appropriate balance between enabling access to care while ensuring patient safety. The Workgroup was charged with guiding the development of model guidelines for use by state medical boards in evaluating the appropriateness of care as related to the use of telemedicine, or the practice of medicine using electronic communication, information technology or other means, between a physician in one location and a patient in another location with or without an intervening health care provider.

MODEL POLICY FOR THE APPROPRIATE USE OF TELEMEDICINE TECHNOLOGIES IN THE PRACTICE OF MEDICINE Report of the State Medical Boards’ Appropriate Regulation of Telemedicine (SMART) Workgroup Adopted as policy by the Federation of State Medical Boards in April 2014

Given the rapidity of change in Health 3.0 regulations will not remain statics as HIT evolves further.

50 STATE PDF FILE APRIL 2017 FINAL PASSWORD PROTECT.pdf