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Rebekah Powers was 11 when members of her faith group, the People of Praise, gathered around as she sat on a chair and laid their hands on her to pray. Powers sister had shown a gift for speaking in tongues, a defining trait of the followers of the small charismatic Christian community, and Rebekah was expected to do the same.

Related: McConnell hits out at Guardian and other media over Amy Coney Barrett scrutiny

But after what seemed like an eternity, she proved unable to produce a sound.

I couldnt get it, and I stayed there an hour and a half before they gave up and finally said, You just have blockage. You need to just work on your sin and be more open, she said.

The 41-year-old had a rebellious spirit and left People of Praise when she turned 18. It has taken decades of therapy and hard work to overcome the intense feelings of shame and fear of damnation that she said marked her childhood. The Christian faith group, based in South Bend, Indiana, dominated every aspect of her early life, she said.

Next week, Amy Coney Barrett, a conservative appellate court judge who is a prominent member of the 1,700-member strong People of Praise, will sit before the Senate judiciary committee to face questions about her judicial philosophy as part of her controversial confirmation to take a seat on the supreme court. A successful appointment, replacing the liberal Ruth Bader Ginsburg, will cement a conservative dominance on the powerful body.

Democrats have already stated that neither Barretts Catholic faith nor her membership in the People of Praise which has never publicly been discussed or disclosed, but has been examined in press reports will be raised in their questioning of the nominee.

Mitch McConnell, the Senate majority leader who is seeking to confirm Barrett before the end of October, has nevertheless said that media reports and some remarks by senators about a newly discovered public statement by Barrett in opposition to Roe v Wade, were disgusting attacks on faith. He said they risked a return to the tropes of the 1960s, when it was feared by some anti-Catholic bigots that John F Kennedy would act in the interest of the pope instead of the US.

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Our coastal elites are so disconnected from their own country that they treat religious Americans like strange animals in a menagerie, McConnell said in a statement.

But Powers, who is one of a handful of former People of Praise members who contacted the Guardian to describe their difficult experience in the group (using her married name), and some religious scholars who have studied charismatic Christian communities, say Barretts membership in this specific religious community does raise legitimate questions. They want to examine how views that are integral to the groups core beliefs from its treatment of women to the separation of church and state might influence her. They are also distinct from most mainstream Catholic faith.

In the bi-weekly and hours-long meetings that defined Powers childhood, intense prayer and discussions centered on obedience and driving out sin. Powers, who does not know Barrett, frequently witnessed people speaking in tongues and frenzied calls for evil spirits to be expelled, episodes that usually led to exorcisms.

The brainwashing and the groupthink, the female subjugation it was so devaluing

Rebekah Powers

In the strict hierarchy exercised by the group, Powers parents were often asked to take in other members into their home, even though her own family were using food stamps to get by. As a child and teenager, Powers father served as her spiritual head and worked multiple jobs, including being asked to tend to the lawns of the communitys properties, free of charge.

Women who are married, like Barrett, count their husbands as their heads.

We were Catholic, but the Catholicism was on the side. Our life, all of our friends, all of the randoms who were living in our household, were the [People of Praise] community. It was God, she said. The brainwashing and the groupthink, the female subjugation of being there to serve and listen to your spiritual head. It was so devaluing. To me, it instilled such problems.

Powers experiences are in line with a handbook called The Spirit and Purpose of the People of Praise, which was obtained by the Guardian and confirms that people who seek to be members of the group are prayed with for the release of charismatic gifts specifically, speaking in tongues and the gift of prophecy. It also states: Obedience to authority and submission to headship are active responses to the gifts of God.

Although Barrett has not discussed the issue, there is evidence that the former Notre Dame law professor served as a trustee for a school affiliated with the group; lived in the home of a prominent co-founder when she was in law school; and announced the birth of her children in People of Praises magazine, which has removed references to Barrett and her family since she joined the federal bench in 2017.

The Washington Post reported this week that Barrett served as a handmaid as late as 2010, a leadership position for women in the community, according to a directory.

Barretts father, Mike Coney, who has served in a leadership position in the People of Praise, described his own decision to join the group in a 2018 testimonial at his Catholic church, describing how he had initially unwillingly attended a charismatic seminar as a young man. When prayed with for a greater outpouring of the Holy Spirit, nothing happened. Then later that night I began to speak in tongues. More importantly, I was filled with an insatiable appetite for reading scripture and spiritual books, he wrote.

Thomas Csordas, an anthropology professor at the University of California San Diego who has studied the issues around communities like People of Praise, said it was wrong to focus attention on whether the group could be a considered a cult in the spirit of Jim Joness Peoples Temple. It was much more appropriate, he said, to examine what he called the intentional community of People of Praise and its nature of being conservative, authoritarian, hierarchical, and patriarchal.

I think theyre potentially more dangerous and much more sophisticated [than a cult], he said. It is not the kind of group where submission of women to men means that they have to stay barefoot and pregnant. Instead, they have to be lawyers and judges and submissive to men at the same time. They have to be able to have a career and seven kids at the same time.

Far from taking her cues from the People of Praise, Csordas said, Barretts biography showed she was not a mindless devotee of a cult, but rather part of the elite of the intentional charismatic covenant community, reflecting her previous status as a handmaiden and trustee of the school, and her fathers leadership role.

Related: Revealed: Amy Coney Barrett lived in home of secretive Christian groups co-founder

Contrary to a situation in which people might worry she might be told what to think or told by her husband. Being that far into the community means, no, she is going to be teaching other people. She already knows what to think because of the patriarchal structure she was raised in, which mirrors conservative Catholic views and the views of her judicial mentor, Antonin Scalia.

Massimo Faggioli, a professor of theology at Villanova University, said that even if senators declined to question Barrett about her faith, the issues deserved to be aired in other forums because groups like People of Praise, he said, does reject a secular view of separation between church and state.

I dont think we should put her Catholicism on trial, but the Catholic conservative legal movement is putting liberalism on trial. They want to change a certain understanding of the liberal order of individual rights, and that is coming from the religious worldview of Catholic groups, he said.

Maybe not in the Senate, but in the public square.

A spokesman for People of Praise has said it would be inappropriate to discuss Barrett. He has also said the organization is an ecumenical community that strives to allow men and women with a wide variety of political and religious views to live together in harmony.

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The Crypto Daily Movers and Shakers October 10th, 2020 - Sports Grind Entertainment

Although rheumatoid arthritis (RA) only affects 1% of adults in most countries, up to 17% of these patients have a major depressive disorder (MDD). However, not all patients are assessed for their mental well-being even though detecting and managing depression could optimize the care of patients with RA, according to a review published in Rheumatology and Therapy.

Not only is depression 2 times more common in patients with RA than in the general population, but studies have shown there is a bidirectional relationship: the chronic inflammation impairs effective coping behaviors to stress, which results in depression that in turns leads to worse long-term outcomes.

In RA, quality of life (QoL) is significantly decreased because of pain, fatigue, and disability, causing mood change in the form of anxiety and depression, the authors wrote. Observational studies have described a high prevalence of depression and anxiety in RA; [MDDs] are detected in 17% of RA patients, and local and systemic inflammation plays an important role in anxiety and depression.

The authors reviewed previously conducted studies on the impact of depression on disease activity in RA and vice versa.

Patient-reported outcomes like baseline bodily pain and fatigue not only affect QoL and high disease activity but also likely increase depression. There is a relationship between the disease activity score using 28 joints and QoL, and patients with a higher degree of pain had a higher reduction in QoL, the researchers wrote.

A survey by the National Rheumatoid Arthritis Society found that 90% of patients with RA reported fatigue was the main factor causing low mood and depression, with 89% reporting they experienced chronic fatigue and 79% never being assessed to determine their level of fatigue.

RA patients report the effect of the disease on their mental well-being and frequently describe tearfulness, irritability, frustration, anxiety, and depression, the authors explained.

Depression is the most common mental health disorder associated with RA, and presents with low mood, low self-esteem, fatigue, lethargy, and more. In addition, MDD can present with more aggressive symptoms of depression and can potentially be fatal if left untreated since it also presents with suicidal ideation.

Studies have shown that depression reduces medication adherence and that patients with depression may have reduced physical exercise and social interaction because their coping responses to pain, fatigue, and disability are impaired.

RA patients diagnosed with depression have reduced rates of clinically significant RA remission, increased pain, worse function and quality of life, and increased mortality, the authors wrote. PROs hence become an essential factor for optimising the holistic care of RA.

The researchers noted that studies have found that biologic disease-modifying antirheumatic drugs (DMARDs) and conventional synthetic DMARDs can improve depressive symptoms in patients with RA. However, when depression is present in patients with RA before they start on biologic DMARDs, it can reduce treatment response.

Further observational studies for early detection of anxiety and depression in RA patients using web-based questionnaires would be of help for both patients and clinicians, the authors concluded.

Reference

Lwin MN, Serhal L, Holroyd C, Edwards CJ. Rheumatoid arthritis: the impact of mental health on disease: a narrative review. Rheumatol Ther. 2020;7(3):457-471. doi:10.1007/s40744-020-00217-4

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The Bidirectional Relationship Between Depression and Rheumatoid Arthritis - AJMC.com Managed Markets Network

Objectives:Identify 24-hour activity-sleep profiles in adults with arthritis and explore factors associated with profile membership.

Methods:Cross-sectional cohort, using baseline data from two randomized trials studying activity counselling for people with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) or knee osteoarthritis (OA). Participants wore activity monitors for 1-week and completed surveys for demographics, mood (Patient Health Questionnaire-9) and sitting and walking habits (Self-Reported Habit Index). 1440 minutes / day stratified into minutes off-body, sleeping, resting, non-ambulatory, and intermittent or purposeful ambulation. Latent class analysis determined cluster numbers; baseline-category multinomial logit regression identified factors associated with cluster membership.

Results:172 people (RA: 51%, OA:30%, SLE: 19%). Clusters: High Sitters: 6.9 hours sleep, 1.6 hours rest, 13.2 hours non-ambulatory, 1.6 hours intermittent and 0.3 hours purposeful walking. Low Sleepers: 6.5 hours sleep, 1.2 hours rest, 12.2 hours non-ambulatory, 3.3 hours intermittent and 0.6 hours purposeful walking. High Sleepers: 8.4 hours sleep, 1.9 hours rest, 10.4 hours non-ambulatory, 2.5 hours intermittent and 0.3 hours purposeful walking. Balanced Activity: 7.4 hours sleep, 1.5 hours sleep, 9.4 hours non-ambulatory, 4.4 hours intermittent and 0.8 hours purposeful walking. Younger age [OR: 0.95 (95% CI: 0.91-0.99)], weaker occupational sitting habit [OR: 0.55 (95% CI: 0.41-0.76)] and stronger walking outside habit [OR: 1.43 (95% CI: (1.06-1.91)] were each associated with Balanced Activity relative to High Sitters.

Conclusions:Meaningful subgroups were identified based on 24-hour activity-sleep patterns. Suggesting tailoring interventions based on 24-hour activity-sleep profiles may be indicated, particularly in adults with stronger habitual sitting or weaker walking behaviors.

Keywords:24-hour activity and sleep profiles; accelerometry; adults; arthritis; habit strength; latent class analysis.

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24-hour Activity and Sleep Profiles for Adults Living with Arthritis: Habits Matter - DocWire News

Arthritis is a common condition that causes pain and stiffness in and around the joints. In fact, there are over 100 types of arthritis that affect the hand and wrist joints, with osteoarthritis, rheumatoid arthritis, psoriatic arthritis and gout being the main offenders, exercise physiotherapist Kusal Goonewardena tells Starts at 60.

[This can] result in decreased mobility, reduced strength and a lack of function especially grip strength and inability to use fingers effectively, he explains.

The good news is exercise can help certain hand exercises can help to reduce pain, stiffness and swelling, and improve joint flexibility. So what are some good exercises that can help ease the pain? Below, with the help of Kusal, weve listed five easy hand exercises that you can do from the comfort of your own home. Just be sure to check with your doctor or physiotherapist before starting a new routine.

Place your palms together in a prayer position. Then keep your palms pressing together as you move your hands above your head. Hold for 30 seconds before moving your hands down. Kusal says to repeat this step two more times.

Read more here:
5 easy hand exercises for people with arthritis - Starts at 60

In patients with rheumatoid arthritis (RA), the diagnostic performance of screening instruments for depression was good, while screening instruments for anxiety were more variable, according to study results published in Arthritis Care & Research.

Previous studies reported higher rates of depression and anxiety in patients with RA, compared with the general population. As there are limited data on the diagnostic performances of available tools for assessing depression and anxiety in RA, the goal of the current study was to investigate the validity, reliability and optimal cut point of multiple screening instruments for mental disorders for patients with RA.

The study cohort included adults with RA, recruited through the Arthritis Centre clinic in Winnipeg, Manitoba, and through community clinics between November 2014 and July 2016.

Each participant completed the Patient Health Questionnaire (PHQ-2 or PHQ-9), the Patient Reported Outcomes Measurement Information System depression short form 8a and anxiety short form 8a, the Hospital Anxiety and Depression Scale anxiety score (HADS-A) and depression score (HADS-D), the Overall Anxiety Severity and Impairment Scale, the Generalized Anxiety Disorder 2-and 7-item scales, and the Kessler-6 scale.

Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Axis I Disorders (SCID-1) research version was used as the criterion standard to confirm clinical depression and anxiety disorders in the study participants.

The study included 150 participants (127 women, mean age 59.8 years) who completed the SCID-1 shortly after enrollment. Using the criterion standard of the SCID-1 to confirm clinical diagnosis, the prevalence of current depression was 11.3%, prevalence of generalized anxiety disorder was 7.3%, and prevalence of any anxiety disorder was 19.3%.

For depression, Kessler-6 scale and the HADS-D (cut point 11) had the lowest sensitivity (35% for both) and the highest specificity (96% and 94%, respectively). Sensitivity was highest for the PHQ-2 (88%) and PHQ-9 (87%), with specificity of 84% and 77%, respectively.

For anxiety, sensitivity was highest for the HADS-A with a cut point 11 points (91%), and lowest for HADS-A with a cut point 8 points. While the specificity was lowest for the former (45%), it was the highest for the latter (91%).

All depression and anxiety instruments had acceptable internal consistency and reliability. For depression instruments, internal consistency ranged between 84% to 97% and the test-retest reliability interclass correlation coefficient ranged between 84% and 88%. For anxiety instruments, internal consistency ranged between 69% to 93% and the test-retest reliability interclass correlation coefficient ranged between 69% and 83%.

Based on the area under the curve, the diagnostic performances of all the depression and anxiety instruments were remarkably similar. While the diagnostic performance for depression was generally good, it was not excellent (area under the curve <0.90). The diagnostic instruments for anxiety were less accurate than those for depression; performance was better for identifying generalized anxiety disorder than for any anxiety disorder.

The study had several limitations, among them are the inclusion of patients from the same region indicating that the findings may not apply to other settings, limited access to biologic therapies and mental health support, potential participant bias, and potential limitations due to administration of multiple instruments at the same time.

[T]he optimal choice of screening instrument, and optimal cut point, may vary depending on the situation and purpose of administration. Regardless, incorporation of screening tools for depression and anxiety into clinical practice may improve outcomes for patients with RA, wrote the researchers.

Hitchon CA, Zhang L, Peschken CA, et al. Validity and reliability of screening measures for depression and anxiety disorders in rheumatoid arthritis. Arthritis Care Res (Hoboken). 2020;72(8):1130-1139.

More here:
Diagnostic Performances of Depression and Anxiety Screening Measures in Rheumatoid Arthritis - Rheumatology Advisor

Novel selective oral Janus activated kinase (JAK) inhibitors, tofacitinib, baricitinib, and upadicitinib, improve disease control and quality of life of patients with rheumatoid arthritis (RA), but there are also several safety concerns, including potential increased risk for infection and venous thromboembolism, according to study results published in Mayo Clinic Proceedings.

As a family of intracellular tyrosine kinases, JAKs are involved in the pathogenesis of various inflammatory and autoimmune disorders. There are 4 members in the JAK family: JAK1, JAK2, JAK3, and receptor tyrosine kinase 2 (TYK2). Currently, there are 3 FDA-approved oral JAK inhibitors for the treatment of RA: tofacitinib, which inhibits JAK1/3 with less inhibition of JAK2 and TYK2; baricitinib, an inhibitor of JAK 1/2 with moderate activity against TYK2; and upadacitinib, which is a JAK1-selective inhibitor.

The goal of the current systematic review and meta-analysis was to compare the safety and efficacy of these 3 drugs for the treatment of RA.

The researchers performed a systematic search of MEDLINE, EMBASE, and the Cochrane Library through December 11, 2019, to identify randomized controlled trials that included adult patients with active RA, treated with tofacitinib, baricitinib, or upadicitinib. All included studies determined efficacy and safety outcomes.

Of 116 identified clinical trials, 20 studies (8982 unique patients) with a low risk of bias were included in the analysis: 12 tofacitinib trials, 5 baricitinib studies, and 3 designed to test upadacitinib.

All JAK inhibitors were found to be effective in reducing RA disease activity, and the overall pooled analysis showed that the response rate according to American College of Rheumatology 20% (ACR) criteria was 2-fold higher than placebo (relative risk [RR], 2.03; 95% CI, 1.87-2.20; P <.001), and all treatments were associated with significant decreases in Health Assessment Questionnaire Disability Index (HAQ-DI) (mean differences, -0.31; 95 CI, -0.34 to -0.28; P <.001).

Tofacitinib at a dose of 10 mg, twice daily, was associated with the highest response rate according to ACR20 (RR, 2.48; 95% CI, 1.97-3.14; P <.001) and the most statistically significant improvement in HAQ-DI score (mean difference, -0.38; 95% CI, -0.44 to -0.31; P <.001).

The overall incidence of adverse events was higher among patients treated with JAK inhibitors (RR, 1.09; 95% CI, 1.05-1.13; P <.001), but the frequency of serious adverse events in any of the treatment groups was not significantly different compared with placebo.

Tofacitinib given at a dose of 10 mg, twice daily, was associated with the highest risk for infection (RR, 2.75; 95% CI, 1.72-4.41), followed by upadacitinib, 15 mg, daily (RR, 1.35; 95% CI, 1.14-1.60) and baricitinib, 4 mg, daily (RR, 1.28; 95% CI, 1.12-1.45). On the other hand, treatments with tofacitinib 5 mg, twice daily, baricitinib at a daily dose of 2 mg, or upadacitinib 30 mg daily, were not associated with an increased risk for infection.

Data on venous thromboembolism was only available from upadacitinib trials, indicating the JAK inhibitor was not associated with a significant increase in risk for venous thromboembolic disease.

The study had several limitations, including the small number of trials with baricitinib and upadacitinib, significant heterogeneity in study design, follow-up duration and treatment duration. Furthermore, in some trials patients in the placebo group switched to active treatment during the follow-up.

Longer-term follow-up and additional trials with head-to-head comparison of tofacitinib, baricitinib, and upadacitinib, as well as additional information from ongoing trials of these and other JAK inhibitors, including peficitinib and filgotinib, will be important to further determine both efficacy and the safety profile of these agents in the management of RA, wrote the researchers.

Wang F, Sun L, Wang S, et al. Efficacy and safety of tofacitinib, baricitinib, and upadacitinib for rheumatoid arthritis: a systematic review and meta-analysis. Mayo Clin Proc. 2020;95(7):1404-1419. doi:10.1016/j.mayocp.2020.01.039

Read more here:
Efficacy and Safety of JAK Inhibitors for the Treatment of Rheumatoid Arthritis - Rheumatology Advisor

It can leave the joints feeling sore and inflamed, and could even damage the surrounding cartilage or tendons.

On some occasions, the symptoms can extend to other parts of the body, including the lungs or heart.

Around 400,000 people in the UK have been diagnosed with rheumatoid arthritis.

One of the key warning signs of the condition is developing a high fever.

READ MORE: Rheumatoid arthritis - vitamin to reduce risk

"Rheumatoid arthritis mainly attacks the joints, usually many joints at once," said the US Centers for Disease Control Prevention.

"With rheumatoid arthritis, there are times when symptoms get worse, known as flares, and times when symptoms get better, known as remission.

"Signs and symptoms of rheumatoid arthritis include: Pain or aching in more than one joint, stiffness in more than one joint, weight loss, fever, fatigue, weakness.

"Signs and symptoms of rheumatoid arthritis are not specific and can look like signs and symptoms of other inflammatory joint diseases."

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Five common signs of painful rheumatoid arthritis that you may be missing - Express

Active wheelchairs resemble most of the sports wheelchairs available in the market and are easy to maneuver. These wheelchairs are utilized on a daily basis and are usually more of a premium product than the usual, standard wheelchairs. It also comprises wheelchairs for people who want to remain active in life. Most of the sports wheelchairs are the active wheelchairs. Easily navigable, these wheelchairs come in two different forms, which are rigid or folding. These chairs can be easily adjusted to cater to the need of the users and their lifestyle, which is estimated to support growth of the global active wheelchair market over the period of forecast, from 2019 to 2029.

Rising in the number of disabled and geriatric population across the globe is likely to accentuate the demand for active wheelchairs in the near future. In addition, constant efforts to better the efficiency of these wheelchairs, favorable initiatives by the government, and rise in the incidences of chronic diseases is likely to trigger growth of the global active wheelchair market in the years to come.

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Type, indication, and region are the three key parameters based on which the global active wheelchair market has been divided. The objective of such segmentation is to offer a clearer, 360-degree view of the market.

Global Active Wheelchair Market: Notable Developments

The global active wheelchair market has witnessed significant developments in the recent years. One of such developments pertaining to the market is mentioned below:

Some of the key players in the global active wheelchair market comprise the below-mentioned:

Global Active Wheelchair Market: Key Trends

The following drivers, restraints, and opportunities characterize global active wheelchair market over the assessment period, from 2019 to 2029.

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In comparison with a traditional wheelchair, this active one is considered an upscale product. Active wheelchairs are considered a blessing for people who prefer to remain active, which is why it has gained tremendous popularity in the last few years.

According to the findings of Centers for Disease Control and Prevention (CDC), nearly 54.4 million adults in the US were suffering from arthritis in the period that spanned from 2013 to 2015. In addition, it is also forecasted that nearly 36.4 million people with arthritis is estimated to have limited activities by 2040. With such increased prevalence of disabilities, the global active wheelchair market is likely to observe considerable growth over the period of assessment, from 2019 to 2019.

In addition, rise in the disposable income of the people together with increasing approvals of product is forecasted to work in favor of the global active wheelchair market in the years to come. There are many government policies encouraging adoption of these wheelchairs, which is likely to pave way for accelerated adoption of active wheelchairs in the years to come.

Global Active Wheelchair Market: Geographical Analysis

Expanding base of geriatric population together with rising expenditure on healthcare is likely to place Europe at the forefront of the global active wheelchair market. The dominance of Europe over the market is likely to continue throughout the period of forecast. Asia Pacific is estimated to come up as a rapidly growing region with rising disposable income and inclination toward spending on premium medical devices.

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The global active wheelchair market is segmented as:

Type

Indication

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Excerpt from:
Active Wheelchair Market | High Prevalence of Arthritis to Contribute toward Spiraling Demand for Active Wheelchairs - BioSpace

Oscar Klefbom has played with shoulder pain for a few years. And hes lived with it daily. His shoulder discomfort has even made sleeping uncomfortable at times during the hockey season.

Two different sources confirmed Klefboms shoulder ailment has been an issue for years.

Im told he is dealing with chronic arthritis in his shoulder, and surgery isnt an easy fix. There is no guarantee it will solve the problem, and the major concern for Klefbom is if he has surgery and nothing improves, it might make it worse. A medical person explained that one reason to have surgery would be to debride the joint and possibly take a part of the acromion (a bony process on the scapula) to give him better function in his shoulder.

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Today, Oilers GM Ken Holland addressed Klefboms status.

I dont think its that simple, said Holland responding to why didnt Klefbom have surgery once the Oilers were eliminated.

If he needs it, why doesnt he get surgery and why wait two months? Then youve lost two months. If it was that easy, he would make those decisions but its not that easy. He played with some pain. In February we shut him down for I think nine games. He went to see a shoulder specialist, and again its not cut and dry.

Its not as simple as you do have surgery or you dont have surgery. I think Klef needs to make a decision based upon the information that hes given from his body and the doctors hes seen a couple of shoulder specialists and see how he wants to proceed.

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In past years the season has ended and theres been a long offseason for it (his shoulder) to get better and he comes back and he plays. But as he goes forward each year the body is another year older and beat up a little more. He has to decide how he wants to proceed and again, from the clubs perspective, would you like to have an answer? Yeah. But, I always think Ive got to respect that this is an important player on the team, but hes also a person who has to make a decision that is going to be very important to him going forward in his life and I have to respect that.

Hollands response about it being an issue that isnt easily fixed by surgery matches with my sources confirming Klefbom is dealing with arthritis.

Klefbom has tried different treatments to fix it, and often the pain subsides, but then it reappears during the wear and tear of an NHL season.

Holland also mentioned it is likely Klefbom wont be ready to start the season, and could possibly be sidelined for the entire year.

Will surgery help? They dont know and that is why Klefbom is not rushing into a decision. It could have a huge impact on how much longer he is able to play.

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Edmonton Oilers: Oscar Klefbom Dealing With Arthritis - Oilers Nation

Low-impact exercise like biking is a great way to keep your joints healthy.

Image Credit: adamkaz/E+/GettyImages

More than 54 million Americans have arthritis, according to the Centers for Disease Control and Prevention (CDC). That's more than 1 in 5 people. While there are some known risk factors that can lead to this common condition, many such as a person's genes are outside of our control.

But not all of them. "Some [forms of arthritis] are preventable, others are modifiable," says Daniel Wallace, MD, rheumatologist and spokesperson for Voltaren.

There are also many tactics that can help improve your overall joint health. That's important, since healthy joints allow you to move with ease and aid in protecting your bones, per the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD).

Arthritis refers to any type of pain or swelling in the joints, and there are more than 100 varieties, per Stuart D. Kaplan, MD, chief of rheumatology at Mount Sinai South Nassau in Oceanside, New York.

The most common type is osteoarthritis (OA), also known as degenerative arthritis, according to the Arthritis Foundation. As protective cartilage wears away, bones touch at joints sometimes, youll hear OA referred to as wear-and-tear arthritis.

The other most commonly diagnosed variety is rheumatoid arthritis (RA), an inflammatory type. Its an auto-immune disease, which means the body is fighting itself. It can attack the joints, which become red-hot and swollen, Dr. Kaplan says.

Some risk factors apply to only one of these two common forms.

Here are a few science-backed tactics that'll help reduce your arthritis risk factors, along with promoting good joint health.

1. Maintain a Healthy Weight

Carrying around extra pounds puts extra pressure on your knees, Dr. Tariq says.

Image Credit: Rostislav_Sedlacek/iStock/GettyImages

"Obesity is a big risk factor for osteoarthritis, especially in the weight-bearing areas, like the knees and lower back," Saad Tariq, MD, a rheumatologist with Ortho Illinois, tells LIVESTRONG.com.

The pressure on your knees adds up to 1.5 times your body weight, per Harvard Health Publishing and that's on level ground; it's even higher on inclines (like steps) and can be up to five times your body weight when you squat to, say, tie your shoe.

That's why people with obesity are more likely to develop OA in these areas, per the CDC. And since excess fat leads to inflammation-causing proteins circulating in your body, obesity ups your risk of developing OA in your hands, too, per the Arthritis Foundation.

"Trying to modify the diet, and trying to exercise to lose weight can definitely prevent end-stage bone-on-bone arthritis [osteoarthritis] and chronic pain," Dr. Tariq says. (More on diet and exercise in a minute.)

2. Consider Following a Mediterranean Diet

There's no diet that can prevent arthritis (nor, for that matter, is there a diet that can cure this condition). That said, a healthy diet will help you manage your weight.

And there's one diet that might be particularly helpful to follow: "The Mediterranean diet has been shown consistently to be helpful for reducing inflammation," Dr. Tariq says. That's key, since both RA and OA involve inflammation in the joints.

Following the Mediterranean diet means eating lots of vegetables, fruits, fish, whole grains and healthy fats, while limiting red meat, according to the Mayo Clinic. It's linked to weight loss and a lower BMI, per a March 2019 review published in Nutrients.

The Mediterranean diet was helpful for managing symptoms in people with RA, but there wasn't enough evidence to support that the diet prevented RA in a December 2017 systematic review published in Rheumatology International.

But this diet may help to prevent RA in former and current smokers, according to a September 2020 study published in Arthritis & Rheumatology. And, while acknowledging some limitations in studies, an August 2018 review published in the journal Nutrients noted that OA prevalence is lower in people with high levels of adherence to the Mediterranean diet.

An apple a day may do more than keep the doctor away.

Image Credit: DjelicS/E+/GettyImages

Arthritis is an inflammatory disease the symptoms of this condition spring from inflammation in the joints.

Consuming a high-fiber diet can decrease inflammation and improve osteoarthritis, Dr. Tariq says. Consuming higher fiber levels was associated with a lower risk of developing symptomatic OA in the knee, per a May 2017 study in Annals of the Rheumatic Diseases.

Fruits, vegetables, whole grains and legumes are all good sources of fiber, per the Mayo Clinic.

It may also be helpful to limit or avoid inflammatory foods that can make symptoms worse. These include refined carbohydrates (think: white bread and pastries), fried foods, sugary beverages like soda, red and processed meats and margarine, according to Harvard Health Publishing.

It's hard to even tally up the reasons to quit smoking because this habit is so negative to nearly every facet of your health.

Smoking is a risk factor for developing RA, per the CDC.

It's a preventable risk factor for osteoarthritis, too, Dr. Tariq says, because smoking can lead to bone deterioration.

Gum disease and RA are connected.

Image Credit: Natalia Bodrova/iStock/GettyImages

Practicing good dental hygiene brushing several times a day, and flossing too can help prevent gingivitis (gum disease), which may lead to RA, Dr. Tariq says.

Research certainly shows a link between gingivitis and RA. It's possible that inflammation associated with the teeth and mouth may "play a role in the development of rheumatoid arthritis," per a May 2013 review in Current Opinion Rheumatology. And more recently, a December 2016 study in Science Translation Medicine found that the bacteria involved in gingivitis also triggers the inflammatory response found in people with RA.

More research is needed here, though, as the Cleveland Clinic notes, to fully understand if one condition triggers the other one. Still, since gum disease isn't a desirable outcome either, it's a good idea to take care of your pearly whites.

Along with helping you to maintain a healthy weight, exercise is also good for keeping muscles and joints healthy, Dr. Kaplan says.

"Any kind of exercise that doesn't strain muscles is good," he says, and cautions people to start gradually especially if it's been a while since you've been active and build up to a higher tolerance and endurance.

The stronger your muscles, the better they're able to protect your joints and potentially prevent osteoarthritis, per University of Iowa Health Care. Plus, physical activity helps prevent stiffness in your joints, according to the University of Rochester Medical Center.

"In general, I recommend range-of-motion exercises things that keep the joints moving, like walking, swimming, bicycling," Dr. Kaplan says.

7. Prevent Joint Injuries

Working to strengthen your knees can help reduce your risk of OA.

Image Credit: fizkes/iStock/GettyImages

OA is mainly thought of as a disease that accompanies age with a lot of use of the joint, cartilage wears down, leading to friction and the dreaded bone-on-bone contact.

But OA can also be the result of an injury caused by physical activity or accidents, per the Mayo Clinic.

Of course, you can't retreat to a bubble to avoid injuries and accidents. But there are reasonable and prudent tactics you can take to protect your joints:

Do Knee Exercises (Particularly if You Do Activities With a Risk of ACL Tears)

People who injure their anterior cruciate ligament (ACL) up their risk of having knee OA later in life by three to six times, per the Osteoarthritis Action Alliance (OAAA). But by doing neuromuscular training exercises proposed by the OAAA which include balance training, plyometric jumping and core strengthening you can cut the risk of an ACL or other knee injury by 80 percent.

That's worth considering if you play a sport such as football or soccer where ACL injuries are common.

We've all heard it: Lift with your legs, not your back. But the advice is solid to protect your back, Dr. Tariq says.

To lift objects correctly, per the American Chiropractic Association, follow these best practices:

Listen to your body, Dr. Tariq recommends if something hurts, avoid doing it.

If your work involves lifting heavy objects, take particular care, Dr. Tariq says. Try to regularly do back exercises and strengthen those muscles, he says. Exercising the parts of the body that are frequently in use will prevent stiffness and pain.

Avoid the prolonged sitting (first in front of the computer, then later on the couch) that can take over a person's day, Dr. Tariq says. Why? Joint injuries are more common if you hold a position for a while, per the American Chiropractic Association.

"Every hour, try to get up and stretch and change your posture," Dr. Tariq recommends. Doing so will reduce pain and stiffness.

Take a look at your posture when you're sitting for long periods at your desk or during a long drive, he says. Having a neutral posture helps reduce aches and prevent pain.

See the original post:
How to Prevent Arthritis and Stop Arthritis From Progressing - LIVESTRONG.COM

The white blood cell TH17 helps the immune system fight infection by promoting inflammation. But it can be too much of a good thing: Excessive inflammation from TH17 overload has been tied to autoimmune disorders, such as inflammatory bowel disease (IBD) and arthritis.

Researchers led by Hening Lin, professor of chemistry and chemical biology in the College of Arts and Sciences and a Howard Hughes Medical Institute Investigator, have found a new way to potentially treat IBD as well as other autoimmune disorders by targeting a mechanism that regulates the signaling pathway that enables TH17 to be produced and inflammation to occur.

Their paper, A STAT3 Palmitoylation Cycle Promotes TH17 Differentiation and Colitis, published Oct. 7 in Nature. The lead author is postdoctoral researcher Mingming Zhang.

The production of TH17 is a chain reaction of sorts, built around the STAT3 protein. When the body detects infection, it secretes cytokine molecules that bind to the plasma membrane of a precursor T cell and activate the enzyme JAK2. This enzyme, in turn, is responsible for activating STAT3 by adding a phosphate group to it, a process known as phosphorylation. Once turned on, STAT3 directs the expression of the interleukin 17 gene and causes TH17 cells to develop.

At least, thats the way the process has been traditionally understood. Lins group discovered a new mechanism that regulates this pathway.

For JAK2 to phosphorate STAT3, they have to be in the same location. Previously, people didnt know theres a mechanism that promotes STAT3 going to the plasma membrane, Lin said. What we found is that there is an enzyme called DHHC7 that does that job.

The DHHC7 enzyme is a kind of matchmaker. It helps STAT3 go to the plasma membrane, where JAK2 is located, by applying a fatty acid, or lipid, to the protein. The lipids greasiness directs STAT3 to the plasma membrane so phosphorylation can take place.

However, thats only half of the process. STAT3 still needs to detach from the plasma membrane and make its way to the nucleus. Thats when another enzyme, APT2, comes in and removes the lipid modification, freeing STAT3 so it can move to the nucleus and deploy the interleukin 17 gene that will cause TH17 cells to develop.

Lins group found that inhibiting this two-part lipid modification cycle in mice prevents the STAT3 protein from making its long journey to the nucleus, thereby suppressing inflammation and, ultimately, colitis, which is a form of IBD.

Theres no effective treatment for colitis, and the exact cause is not very clear. But we do know that TH17 cells play some role in it, Lin said. We found that this cycle of putting on a lipid modification and then removing it promotes TH17 cell differentiation. And when we inhibit or delete these two enzymes, DHHC7 or APT2, we can protect the mice from getting colitis.

Other researchers have targeted JAK2 with the same goal, but that enzyme can be difficult to target specifically, and inhibiting it can create toxicity. APT2 is easier to inhibit, and disrupting it does not seem to cause any severe damage, Lin said.

After analyzing human data, Lins team determined the STAT3 signaling pathway is important in humans, too. Their new method could lead to treatment of a host of autoimmune disorders, such as Crohns disease, multiple sclerosis, rheumatoid arthritis and Type 1 diabetes. It could also help prevent the rejection of organ transplants.

Co-authors include Maurine Linder, professor and chair of the Department of Molecular Medicine in the College of Veterinary Medicine; research scientist Min Yang; research support specialist Xuan Lu; doctoral students Yilai Xu, Garrison Komaniecki and Tatsiana Kosciuk; Xiao Chen, Ph.D. 18; and researchers from Sichuan University, Nanjing University, and Nanjing Medical Univeristy.

The research was supported by the Howard Hughes Medical Institute and the National Institutes of Health.

Read more from the original source:
Researchers disrupt signaling pathway to treat colitis | Cornell Chronicle - Cornell Chronicle

Jaw cracking refers to a clicking or snapping sound in your jaw. Its also known as jaw popping.

Often, the sound occurs with jaw pain and discomfort. You might also have a hard time moving your jaw, depending on the underlying condition.

Jaw cracking usually isnt a cause for concern, though. It can even happen when you widely yawn or open your mouth.

The exception is if you recently sustained a facial injury, which can dislocate or break your jaw. In this case, youll need emergency help.

Read on to learn about the possible causes of jaw cracking and when you should see a doctor.

The potential causes of jaw cracking range in severity and type. They include:

Your temporomandibular joint (TMJ) attaches your jawbone to your skull. If theres something wrong with this joint, its called temporomandibular joint disorder (TMD).

TMD can make your jaw crack or pop. Other symptoms include:

TMD often happens without a specific cause. Occasionally, clenching your teeth due to emotional stress can play a role.

Arthritis occurs when your joints become damaged and inflamed. If it affects your TMJ, it can cause TMD and jaw cracking.

All types of arthritis can lead to TMD. Most cases are due to osteoarthritis, but it can also be caused by rheumatoid arthritis.

Arthritis also causes symptoms in other parts of your body, including:

Facial injuries can dislocate or break your jaw. A dislocation happens when your jawbone moves out of place, while a broken jaw happens when your jawbone breaks.

Common causes of facial injury include:

A dislocated or broken jaw can lead to TMD symptoms, including jaw pain and cracking.

Other symptoms of dislocation include:

If your jaw is broken, youll likely have:

Myofascial pain syndrome (MPS) causes pain in your muscles and fascia. Fascia is the sheet of connective tissue that covers every muscle.

MPS can affect any muscle, including those in your jaw, neck, and shoulder. Its the most common cause of TMJ discomfort.

You may have jaw cracking and popping, along with:

If your breathing briefly and repeatedly stops during sleep, its called obstructive sleep apnea (OSA). This happens when the airways in your throat are too narrow.

OSA increases your chances of developing TMD. The connection is unclear, but its thought that the resistance in your airways triggers a stress response. This may cause your jaw muscles to clench together.

Other symptoms include:

Malocclusion of the teeth occurs when your upper and lower jaws are misaligned. It causes your upper and lower teeth to line up incorrectly.

There are several types of malocclusions, including:

The primary symptom is teeth misalignment, but you can also experience TMD and jaw noises.

Other symptoms include:

Jaw cracking and pain might indicate an infection in your:

Depending on the infection, you may also have:

Jaw infections are often mistaken for TMD. If your doctors treatment for TMD fails to work, be sure to let them know.

If a tumor develops in the oral cavity, it can lead to oral cancer. This may cause symptoms like:

The tumor can also affect how your jawbone moves, causing jaw noises like cracking or popping.

If you have jaw cracking while eating, you might have:

Jaw cracking when you yawn might indicate:

Potential causes of jaw cracking plus ear pain include:

Jaw cracking usually isnt serious. It typically goes away in 2 or 3 weeks. However, you should see a doctor if you have:

If you were recently injured, go to the nearest emergency room. Youll need immediate medical attention.

To stop jaw cracking, youll need to treat the underlying cause.

The following home remedies can be used alone or with medical treatment:

If your jaw cracking is due to a more serious condition, you may need medical treatment. This might include:

Cracking your jaw isnt necessarily harmful. It can happen if you open your mouth wide, like during a big yawn. This is expected and normal.

However, take note if your jaw cracks when you talk or chew. It may indicate a more serious issue, especially if you also have pain.

Try eating softer foods to decrease your jaw activity. If your symptoms persist, see a doctor.

If you have jaw cracking, pay attention to your other symptoms. This can help you determine what might be causing the sound. Be sure to visit a doctor if you have persistent pain, difficulty eating or breathing, or if the jaw cracking gets worse.

Here is the original post:
Jaw Cracking Causes, Treatments, and When to See a Doctor - Healthline

Dexamethasone is a low-cost, anti-inflammatory drug that has been shown to reduce the risk of death in patients with COVID-19. Nati Harnik/AP hide caption

Dexamethasone is a low-cost, anti-inflammatory drug that has been shown to reduce the risk of death in patients with COVID-19.

Editor's note: Since we published this story, Trump's physician said that the president has completed his treatment for COVID-19.

President Trump told Fox Business Network on Thursday that he will be taking a steroid for COVID-19 for a "little bit longer." As his physicians told reporters last weekend, Trump started taking the drug on Saturday while he was still at the Walter Reed National Military Medical Center.

The steroid, dexamethasone, is now part of the "standard of care" for COVID-19, said Dr. Celine Gounder, assistant professor of medicine and infectious diseases at New York University School of Medicine.

"It's an old drug, it's cheap," she said. "Of all the drugs we're using for COVID, it's the one that we have the most experience with."

Dexamethasone is an anti-inflammatory drug used for a range of ailments, including arthritis, kidney, blood and thyroid disorders and severe allergies. The drug is on the World Health Organization's list of essential medicines and is also used to treat certain types of cancer.

Earlier this year, a large clinical trial in the U.K. found that giving dexamethasone to patients hospitalized with COVID-19 reduced their risk of dying. Patients were given 6 milligrams of the drug for 10 days.

The study, published in The New England Journal of Medicine in July, found the drug cut mortality by a third among severely ill COVID-19 patients who were on ventilators, and by a fifth for patients receiving supplemental oxygen. It was found not to have any benefits for patients with mild illness, and there was some evidence of potential harm.

Later in the course of the disease, COVID-19 can cause the immune system to go into overdrive, damaging the lungs and other organs. That's what can happen to people who are severely ill. Dexamethasone helps these patients by tamping down the body's immune response.

The Infectious Diseases Society of America now recommends giving 6 milligrams of the drug for 10 days to critically ill COVID-19 patients on ventilators and those requiring oxygen support. But it recommends not using the drug on people with mild illness who do not require supplemental oxygen.

While this commonly used drug is generally safe, there are a range of known side effects. "By far, the most common is hyperglycemia, so that's where your blood sugars will shoot up," Gounder said.

Also quite common, especially among older patients are a range of psychiatric side effects, she added.

"Anything from feeling like you're on top of the world ... your arthritic aches and pains of age just melt away, you have lots of energy," she said. "There may be some grandiosity."

The drug can also cause agitation, insomnia and even, psychosis, Gounder said. "My own father was treated with high-dose steroids as part of his lymphoma regimen and developed acute psychosis requiring psychiatric hospitalization."

All these side effects point to the need to monitor people on these drugs carefully, she added.

If the president's doctors had prescribed him the recommended course of treatment, Trump would have finished the steroid therapy early next week. On Thursday evening, White House physician Dr. Sean Conley said Trump has completed his COVID-19 treatment.

Excerpt from:
Trump Was Treated With Steroids: How These Drugs Are Used For COVID-19 Patients - NPR

UPPER NYACK, N.Y.--(BUSINESS WIRE)--CreakyJoints Espaol, a digital patient community en Espaol for people with all forms of arthritis and part of the Global Healthy Living Foundation, today announced that the Bristol Myers Squibb Foundation has funded the RA Hispanic Outreach Program, a $1 million, two-year grant to improve relationships between Hispanic people living with rheumatoid arthritis (RA) and rheumatologists. The grant includes creation and dissemination of evidence-based education about RA, developed in patient-friendly formats and language. The project will include assembling an advisory council of Hispanic patients with RA and rheumatologists to collaboratively develop and evaluate educational materials to achieve culturally sensitive and patient friendly interventions that can become part of established care, if found effective.

The COVID-19 pandemic highlighted what we already knew to be true: Hispanics and other communities of color face structural and systemic inequities that contribute to poor access to health care. The Hispanic community faces further barriers related to a lack of understanding of the cultural traditions and attitudes that influence healthcare decision-making, said Daniel Hernandez, MD, Director of Medical Affairs and Hispanic Outreach. Through this program, well employ culturally sensitive approaches to achieve better health literacy about RA within the patient community and drive people to take a more proactive approach to managing a complex, chronic condition. We know that if we can improve communication between doctors and their patients, we can expect better health outcomes.

RA Hispanic Outreach Program Measures Engagement

Although the Hispanic population is the largest minority in the United States, composed of nearly 60 million Americans there are limited disease-specific resources for this community. According to Pew Hispanic Research, 71 percent of Hispanics obtain health information through their social networks, and 79 percent of them act on this information. Also, 41 percent reported making a medical decision regarding the treatment of an illness or medical condition due to some form of outreach.

The RA Hispanic Outreach Program to be created by CreakyJoints Espaol will develop and test patient-centered outcomes and create educational materials that are culturally appropriate and patient friendly. Materials will be developed, then disseminated digitally and in partnership with rheumatology pilot sites, Hispanic community organizations and key opinion leaders. Part of the goal is to use findings to train clinicians to deliver culturally competent care and patient education to develop stronger more-trusting relationships.

We are excited to support Global Healthy Living Foundation and their efforts to deliver accurate and culturally sensitive RA education through the RA Hispanic Outreach Program, said John Damonti, president, Bristol Myers Squibb Foundation. This program aligns perfectly with our commitment to health equity, which focuses on raising disease awareness and education, increasing health care access and improving outcomes for medically underserved populations. It will improve how Hispanic people living with RA communicate with their physicians and make decisions about their health care.

Using CreakyJoints Espaol digital channels, the organization will use online evaluation methods to develop and test patient-centered outcomes measures. The participatory nature of the study will allow the team to add patient outcome measures during the early phases of the study, thereby increasing the flexibility and comprehensiveness of the program. Online communication and participation via websites and social media with analytics will help ensure the measured outcomes are meaningful to a medically underserved community to improve health equity and outcomes.

Recognizing that social media is the most frequent source of medical information for people in the Hispanic community, the program will use novel and innovative methods to create mobile-first content designed for best use on mobile phones but also available on tablets, websites, television, podcasts, radio or print.

We created CreakyJoints Espaol to meet the needs of Hispanic communities looking for evidence-based advice about managing the different forms of arthritis. We are gratified to see engagement with our platforms grow as weve introduced programming related to Rheumatoid Arthritis Patient Guidelines, our Spanish-language COVID-19 resources, and our research, such as the our COVID-19 patient research registry, ProyectoCovid19.org and ArthritisPower, a bone, joint and skin condition patient registry, said Louis Tharp, executive director and co-founder of CreakyJoints and the Global Healthy Living Foundation. We thank the BMS Foundation for their generous award and look forward to implementing and reporting on how our interventions are positively impacting how patients in the Hispanic community are managing their RA.

About Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Bristol Myers Squibb Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.

About CreakyJoints Espaol

CreakyJoints Espaol offers a repository of Spanish language arthritis educational information at http://creakyjoints.org.es and engages with the Spanish-speaking arthritis community via its social media channel: @creakyjoints_esp (Instagram). CreakyJoints Espaol is conducting longitudinal research about the evolving impact of COVID-19 on people living with arthritis in English and Spanish via the Autoimmune COVID-19 Project.

About CreakyJoints

CreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research. We represent patients through our popular social media channels, our websites http://www.CreakyJoints.org, https://creakyjoints.org.es/, http://www.creakyjoints.org.au, and the 50-State Network, which includes more than 1,500 trained volunteer patient, caregiver and healthcare activists.

As part of the Global Healthy Living Foundation, CreakyJoints also has a patient-reported outcomes registry called ArthritisPower (ArthritisPower.org) with more than 29,000 consented patients with joint, bone, GI and inflammatory skin conditions who track their disease while volunteering to participate in longitudinal and observational research. CreakyJoints also publishes the popular Raising the Voice of Patients series, which are downloadable patient-centered educational and navigational tools for managing chronic illness. It also hosts PainSpot (PainSpot.org), a digital risk assessment tool for musculoskeletal conditions and injuries. For more information and to become a member (for free), visit http://www.CreakyJoints.org.

Find us on social media:Facebook: https://www.facebook.com/creakyjoints andhttps://www.facebook.com/GlobalHealthyLivingFoundation/ Twitter: @GHLForg, @CreakyJoints, #CreakyChatsInstagram: @creaky_joints, @creakyjoints_aus, @creakyjoints_esp

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CreakyJoints Espaol Awarded $1Million Grant to Promote Health Equity and Improve Health Outcomes Among Hispanics Living with Rheumatoid Arthritis -...

A Laois mother of four is going to run a marathon virtually from her doorstep, for a charity that is helping her teenage daughter to cope with arthritis.

On Sunday October 25, the day of the cancelled Dublin City Marathon, Melissa Fenelon, 40, will set out from her home in Ballinakill and run to Ballyroan, then Abbeyleix, back to Ballinakill, on to Durrow and finally returning to Ballinakill, the full 42.2km.

She will still get a medal posted out from the marathon organisers on completing her epic 26.2 mile race, but it is not for glory that Melissa is running.

I want to raise awareness and raise money for Arthritis Ireland, that is my number one priority, she said.

Her eldest child Kaitlin was diagnosed last year with a condition called Psoriatic Arthritis, just before her 16th birthday.

An autoimmune disease, psA sometimes develops in people who have psoriasis in their family genes, which is surprisingly as high as one in 50 people.

The body is fighting against itself. She could be fine one day then theres a change in the weather, and her knees ache and get stiff and inflamed, with chronic fatigue.Its very unpredictable. Kaitlin injects herself every second Friday and takes medication. It can flare up anywhere, her fingers, ankles, knees," she said.

Kaitlin attends Heywood Community School and is now in 5th year. Covid-19 is an extra worry.

We cocooned ourselves this year for her and she didnt stir from home, so going back to school is a worry. But her school have been fantastic, and she has a great group of friends," said Melissa.

A lot of people associate arthritis with old people, they dont think that at 17 you might have a disease that makes you feel like a 70 year old at times. People are coming up to me telling me they cant believe it, she said.

Melissa has put sponsorship cards in Hamm's shop, Mcgraths, O'Shaughnessy's bar and Drury's bar in Ballinakill and opened a Facebook fundraiser which reached over 1,600 in less than a week.

Its been absolutely phenomenal, and thats only online, not including the cards. I hoped to get 500, I cant believe it. Everyones behind me, people are brilliant. And Kaitlin is delighted, proud as punch, she said.

Full interview in next Tuesday's Leinster Express.

See her fundraiser here.

Continue reading here:
Mother of teen with arthritis to run marathon in Laois for Arthritis Ireland - Leinster Express

The father-of-three and husband to former model Christine Martin has dealt with a crippling condition for the past three years. What is it?

At 47 years old, Paddy (real name Patrick) has been living with rheumatoid arthritis.

Sharing his diagnosis with the world on social media in 2018, Paddy posted a picture of him pointing towards the bandage on his shoulder.

In the snap, he wrote: "Morning! Nursing a poorly shoulder today. I had an ultrasound steroid injection in it yesterday. The reason, arthritis? I'm 44!"

What is rheumatoid arthritis?

This inflammatory form of arthritis can affect people of any age, testified the charity Arthritis Action.

It's caused by the immune system mistakenly attacking a person's joints, causing pain, stiffness and swelling.

If the condition is promptly treated, joint damage and disability can often be prevented.

The reason why this disease develops is not yet known, but it's been found to run in families.

READ MORE:Arthritis treatment: Apply this herbal cream to significantly reduce pain

Symptoms of rheumatoid arthritis

The condition tends to affect the small joints of the fingers and toes, the wrist, elbows, shoulders and knees, the neck and jaw.

At times, the pain, stiffness and swelling of joints can seemingly move around from joint to joint.

The mornings tend to be the most painful, and symptoms tend to improve during the day.

How to get a diagnosis

Rheumatoid arthritis can be diagnosed via a combination of symptoms, blood tests and X-rays of the joints.

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Medications are available to dampen the immune response, including disease-modifying drugs (DMARDs).

Most people with this condition will be on lifelong medication; there are other treatment options too.

Physiotherapists are able to provide hands-on care and can advise you on exercises.

Podiatrists can help with insoles and foot care, while occupational therapists can offer advice on how to protect the joints.

Meanwhile, Paddy and his wife Christine have said they're "struggling" raising three autistic children.

Six-year-old twins Penelope and Leo and their three-year-old sister Felicity have the condition.

What's autism?

Autism Speaks noted the condition is "characterised by challenges with social skills, repetitive behaviours, speech and nonverbal communication".

The spectrum disorder becomes apparent in children from the age of two or three.

The charity emphasised that "professional evaluation is crucial", as many children with autism don't show all the signs.

Equally as important, many children who don't have autism may show a few of the signs.

What are the signs?

At any age, symptoms of autism can include restricted interests, difficulty understanding other people's feelings, and avoidance of eye contact.

Other signs could include resistance to minor changes in routine or surroundings.

Visit link:
Paddy McGuinness health: The TV presenter opens up on his crippling condition - Express

Transparency Market Research (TMR) has published a new report titled, Small bone and joint orthopedic devices Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the global small bone and joint orthopedic devices market was valued at US$ 5,575.7 Mn in 2018 and is projected to expand at a CAGR of 6.3% from 2019 to 2027.

Overview

Orthopedic devices are implants used to restore skeletal structure and joint movement after fracture, abnormal growth of bones, soft tissue damage, or other deformities. These devices can be surgically implanted or externally attached through minimally invasive procedures and can be classified into internal and external fixation devices.

These devices are used in fractures, trauma, and to correct bone deformities. Under certain circumstances, a joint or a part of it needs to be replaced for proper functioning. These orthopedic devices are known as joint implants. Joint implants are generally used to treat deformities in long and small bone and joints. Implants such as femoral head, humeral head, reverse shoulder prosthesis, prosthesis, and others assist in restoring proper joint movement.

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Extremities orthopedic devices are made of alloys of titanium, stainless steel, polyether ether ketone (PEEK), and polymeric synthetic resorbable materials. Some companies have stopped the manufacture of metal-on-metal implants due to serious injuries and adverse reactions.

Small bone and joints may face difficulty during surgical procedures due to their anatomical complexity and disposition. Hence, various devices, such as Re-motion Total Wrist System by Small Bone Innovations (SBi), have been designed to overcome these intricate procedures. Several key players are working toward providing solutions to eradicate impairments of small bone and joint.

Unmet Needs in Emerging Countries of Asia Pacific and RoW to Provide Growth Opportunities for the Market

Asia Pacific is the fastest growing market for orthopedic devices; however, the region holds a smaller market share as compared to North America and Europe. The demographics and lifestyle changes and higher number of elderly people favor the market growth. There is a rise in per capita income and the knowhow of the medical technologies.

Asia Pacific is also a preferred option for medical tourism for patients in the U.S. where cost of medical services is high. Hence, OEMs can focus on sales, distribution, and target marketing programs in the lucrative market in Asia Pacific.

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On the other hand, the cost of operations in Asia Pacific and RoW is lower than that in organized markets such as North America and Europe due to minimal compliance requirements. Therefore, market players can focus on the lucrative market in RoW, which is unorganized and has low entry barriers.

Fracture Fixation and Replacement Systems Segment to Dominate Market

Based on product type, the global small bone and joint orthopedic devices market has been divided into fracture fixation and replacement systems, plates and screws, external fixation devices, and joint prosthesis.

Orthopedic devices for small bones and joints are used to prevent and/or cure musculoskeletal injuries and disorders of the bones and joints. These devices comprise various implants, internal fixators, and external fixators for application in shoulder, elbow, wrist, hand, ankle, and foot reconstruction or surgeries.

Recently, technologically advanced orthopedic devices have overcome the previous life threatening situations of amputations. Rise in orthopedic procedures and high incidence rates of osteoarthritis and osteoporosis contribute to the growth of the global small bone and joint orthopedic devices market.

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Foot Application Segment to be Highly Lucrative Segment

In terms of application, the global small bone and joint orthopedic devices market has been classified into foot, hand, and shoulder.

Small bone and joint orthopedic devices for foot are majorly recommended for support and alignment, correction of foot deformities, and improving the overall function of foot and ankle.

Advances in plastics and materials science have significantly improved the design and manufacture of foot orthoses in the last couple of decades.

According to a study published in the journal Injury, foot and ankle fractures account for 9% of all the fractures and around 65% of these found in females were osteoporotic. The risk of ankle fracture increases with obesity and osteoporosis.

Other indications include avascular necrosis, traumatic deformity, and arthritis. Fractures of foot and ankle include fractures in metatarsals, calcaneus bones, cuboid bone, and distal head of tibia and fibula. Severe fracture fixation could require internal fixation devices such as wires, plates, and screws or external fixation devices.

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North America to Dominate Global Market

In terms of region, the global small bone and joint orthopedic devices market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global small bone and joint orthopedic devices market in 2018, followed by Europe.

The dominance of these two regions was majorly attributed to growing geriatric and obese populations and introduction of technologically advanced products.

Asia Pacific is considered an emerging market for home rehabilitation products and services Rising disposable income, rapid urbanization, increase in health care infrastructure, and distribution and partnership strategies adopted by the players support market growth in the region.

Competitive Landscape

The global small bone and joint orthopedic devices market is consolidated in terms of number of players. Key players in the global market include Acumed LLC, Arthrex, Inc., Depuy Synthes, DJO Global, Smith & Nephew plc, Stryker Corporation, Tecomet, Inc., Wright Medical Group N.V., Z-Medical GmbH + Co. KG, and Zimmer Biomet Holdings, Inc., among others.

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Small Bone and Joint Orthopedic Devices Market: Increasing Prevalence of Arthritis across Globe to Spur Demand - BioSpace

Oct 8th 2020

OCTOBERS FIRST week is a nervous time for scientists with serious accomplishments under their beltsfor this is when the phone might ring from Stockholm. Those who give out the Nobel science prizes (the Karolinska Institute for the physiology or medicine award, and Swedens Royal Academy of Science for the awards in physics and chemistry) are known neither for offering the winners more than an hour or twos notice of the public announcement of their success, nor for respecting time zones. New laureates in North America receive the news in the dead of night. That, though, is normally reckoned a small price to pay for what is still seen as sciences most prestigious honour.

Britain being in a more convenient time zone from the Swedish point of view, Sir Roger Penrose, of Oxford University, was not actually asleep when his own phone rang. But he was, he says, in the shower. He was one of three winners of the physics prize, the others being Andrea Ghez and Reinhard Genzel, of the University of Californias Los Angeles and Berkeley campuses respectively. Their prize was for the theoretical explanation and subsequent discovery of some of the strangest objects in the universe: black holes.

Black holes are, famously, so dense that nothing, not even light, can escape their immense gravitational pull. A black holes centre is thought to be a point of infinite density, called a singularity, where the known laws of physics break down. Though the possibility that they existed was hypothesised a century ago, as a consequence of Einsteins general theory of relativity (which is actually a theory of how gravity shapes the structure and contents of the universe), early work suggested that they could form only from the collapse of perfectly symmetrical stars or gas clouds. That is hardly realistic, and Einstein himself doubted that they actually existed.

They therefore remained a theoretical curiosity until 1965, when an as-yet-unknighted Dr Penrose worked out the specifics of how real matter could collapse in a way that would form one. He showed, using a mathematical concept which he called a trapped surface, that even asymmetric, clumpy stars and dust clouds could become black holes. This work provided the tools needed by observational astronomers to go out hunting for them.

By definition, it is impossible to see a black hole directly. Instead, physicists glean insights into them by studying the effect of their gravity on the motion of their stellar neighbours. Dr Ghez and Dr Genzel used this idea to gather evidence that Sagittarius A*a bright source of radio waves at the centre of the Milky Way, Earths home galaxyis actually a supermassive black hole around which all the stars in the galaxy, the Sun included, orbit.

Dr Ghez and her team employed the Keck Observatory telescope, in Hawaii, with its ten-metre-wide primary mirror, to make their observations. Dr Genzels group used a series of eight-metre-wide telescopes high in the mountains of the Atacama desert, in Chile, for theirs. These instruments were all sensitive enough to peer through the clouds of dust that otherwise obscure the heart of the Milky Way.

Over three decades both sets of researchers, working independently, tracked around 30 of the brightest stars at the galactic centre (see chart). A star called S2, for example, takes 16 years to complete an orbit of Sagittarius A*, and, at its closest approach, comes within 17 light-hours of it. These measurements have permitted astronomers to piece together a picture of Sagittarius A* as a black hole of around 4m solar masses, packed into a region of space that is about the size of the solar system.

April 2019 saw the release of the first-ever image of a black hole (Sagittarius A*s local equivalent at the centre of a galaxy called M87, 53m light-years from Earth). This was taken, in radio frequencies, using the Event Horizon Telescope, a collaboration that links eight existing radio telescopes all around Earth and thus permits far higher resolution than any single instrument could manage. As technology improves, the Event Horizon Telescope could also one day provide a more detailed image of the region around Sagittarius A*.

As is often the way, the chemistry prize went for a discovery that might equally well have been handed out for medicineCRISPR-Cas9 gene editing. The winners were Emmanuelle Charpentier of the Max Planck unit for the science of pathogens, in Berlin, and Jennifer Doudna of the University of California, Berkeley.

CRISPR-Cas9 is derived from a bacterial defence mechanism that snips small sequences of DNA from viral interlopers and copies them into a bacteriums own genome, thus creating a scrapbook by which to recognise such aggressors, should they come again. The laureates prize is not, though, for the mere discovery of a novel bacterial immune system. It is for the adaptation of that discovery into the most important gene-editing tool yet inventedone that is already helping to design disease-resistant crops and new therapies for cancer, and which may, perhaps, end hereditary disease in human beings.

If an organisms collective DNA can be thought of as the book of its life, CRISPR-Cas9 allows for any specific sequence of words within that book to be identified, selected, removed and replaced. This is done by creating a molecule called a guide RNA, which matches a target DNA sequence, and pairing it with an enzyme, Cas9, that is capable of snipping the DNA helix at this point. Then, if so desired, a new piece of DNA can be inserted.

The laureates path to Stockholm began at a caf in Puerto Rico in 2011. That was when Dr Charpentier, who had discovered intriguing and unexplained RNA fragments in a bacterium, engineered a meeting with Dr Doudna, an expert in the DNA-snipping capability of Cas proteins. Since this collaboration bore fruit in 2012, progress has been rapid. By February 2013 Feng Zhang of the Broad Institute in Cambridge, Massachusetts and George Church of Harvard Medical School had independently demonstrated the techniques effectiveness in mouse and human genomes, paving the way for the treatment of human diseases. Clinical trials are now under way to test its power against sickle-cell anaemia and certain cancers, with animal experiments showing promising results in the treatment of muscular dystrophy.

There has also been controversy. In 2018 He Jiankui of the Southern University of Science and Technology, in Shenzhen, China, announced the birth of twin girls whose embryos he had edited with the help of CRISPR-Cas9. Dr Hes stated goal was to induce immunity to HIV, by disabling the gene for a protein which that virus uses to gain admission to cells. This was too much for the authorities. Even ignoring the issues of consent involved when a procedure is carried out on an embryo, making genetic edits so early in life means that they will be incorporated into germ cells, and thus passed down the generations. That raises serious ethical questions, and what Dr He did was declared illegal by the Chinese government. Dr He is now in prison.

Nor is germ-line editing the only controversy surrounding CRISPR-Cas9. A further complication concerns who gets the patents that will monetise it. The University of California and the Broad have been involved for years in a legal battle over the matter. By giving the prize to Dr Doudna and Dr Charpentier the Royal Academy of Science may have put its thumb on the scales. In picking them it has also, for the first time, awarded a Nobel science prize to an all-female group. Dr Charpentier, via a phone link to the room where the announcement was made, said I hope this provides a positive message to young girls. Women in science can also be awarded prizes. But more importantly, women in science can also have an impact.

Regardless of which category it truly fits into, the creation of CRISPR-Cas9 was a high-end piece of technowizardy. The actual prize for medicine, however, went for a piece of old-fashioned medical detective workthe identification of hepatitis C, a virus that causes life-threatening liver infections and is passed on by exposure to contaminated blood. Though other widespread diseases, such as malaria and HIV/AIDS, gain more attention, the World Health Organisation (WHO) reckons that around 70m people are infected with hep C and that it kills 400,000 people a year. Hep C has also, in the past, turned the business of blood transfusion into a lottery, since there was no way to tell whether a particular batch of blood harboured it. That this is no longer the case is, in no small measure, thanks to the work of this years laureatesHarvey Alter, Michael Houghton and Charles Rice.

Dr Alters work came first. In the 1960s he was a colleague of Baruch Blumberg, who discovered the hepatitis B virus (for which he won a Nobel prize in 1976). Hepatitis viruses are labelled, in order of discovery, by letters of the alphabet. A, a waterborne pathogen, causes an acute infection that passes after a few weeks and induces subsequent immunity. The effects of B and C, though, are chronic and may result eventually in cirrhosis and cancer. Blumbergs discovery led him to a vaccine for hep B, and also meant that blood intended for transfusion could be screened. But it became apparent that such screened blood still sometimes caused hepatitis, albeit at lower rates. Since hep A was also being screened for by this time, that suggested a third virus awaited discovery.

In 1978 Dr Alter, then working at Americas National Institutes of Health, proved this was true by injecting into chimpanzees blood from recipients of transfusions screened for the known viruses who had nevertheless developed hepatitis. These animals sometimes then went on to develop the illness. It took until 1989 to clone the new virus. That was done by Dr Houghton, who was then working at Chiron, a Californian biotechnology firm subsequently bought by Novartis, a Swiss pharmaceutical giant.

Dr Houghton amplified viral genetic material drawn randomly from chimpanzees infected with the as-yet-unidentified virus and tested this against antibodies from infected humans. Antibodies are proteins crafted by the immune system to stick specifically to parts of particular pathogens. By looking at which chimpanzee-derived material the antibodies in question attached themselves to, Dr Houghton was able to isolate the virus and identify it as a type of flavivirus, a group that also includes yellow fever and dengue. He also thus provided a way of screening blood intended for transfusion.

Dr Rice, working at Washington University, in St Louis, Missouri, eliminated lingering uncertainties about whether the flavivirus Dr Houghton had identified was the sole cause of hep C. Attempts to use cloned, purified versions of it to infect chimpanzees had not worked, leading to doubts about whether it was acting alone. Dr Rice identified part of the viral genome which looked crucial to the process of infection, but was highly mutable. He suspected that this mutability was hindering successful infection in the laboratory, and was able to eliminate it by genetic engineering. The stabilised virus was, indeed, infectious to chimps.

The consequence of all this is that blood for transfusion can now be screened routinely for hep C, and drugs to treat it have now been developed. Unfortunately, this has not stopped the march of the illness. Those in rich countries have benefited. Deaths in Britain, for example, fell by 16% between 2015 and 2017. But the wider picture is grim. Some countries, such as Egypt, have recently done well. Others, less so.

One reason is that, besides transfusion, hep C is spread by drug users sharing needles. It can also be spread sexually. This stigmatises it in the eyes of some. And unlike HIV/AIDS, which spreads in similar ways but quickly developed a political lobby to find a treatment once it was discovered, no one spoke up at the beginning for those suffering from the effects of hep C.

That is starting to change. In 2016 the WHO published a strategy for the elimination of all forms of hepatitis. The tools are there to do this. Whether the will to use them also exists remains to be seen.

This article appeared in the Science & technology section of the print edition under the headline "They walked in looking like dynamite"

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Who won this years Nobel science prizes? - The Economist

Today the judicial authority may be faced with balancing patent rights and patients rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.

THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), Our world will only be safer once everyone can benefit from the science and access a vaccine and that is a political challenge.Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces. It is equally a judicial challenge.

I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space.

In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive Who shall live or Whose side are you on? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier.

Public interest is not an either-or factor in (Indias) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South.

By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get canonized as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said (W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare.

The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the Money, money, money in Swedish pop group ABBAs words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creators right is a human right too and has been recognised as such, it is not bound to give way to right to health.

Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance.

The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year.

The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. The right to life, we acknowledge, encompasses several rights each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.

How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.

It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access.

The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion.

The Nagoya Protocol can be used as a tool. What has been overlooked in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.

The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions.

It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access.

It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged. What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer a decision that calls into consideration issues of economic and political viability. In other words, the problem of access moves beyond the realm of the purely legal into the realms of economics and politics.

The judicial authority will have to choose life. Forced to choose between protecting the essential right to life an unalienable right assured by the Constitution (Art.5) or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life. While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be ungranted. The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right.

The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in DArcy v. Myriad Genetics, it is observed, This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly.16

Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives.

This has happened earlier and the South has resisted such corporate and political hegemony that has facilitated the capitalization of health in various forms, and has been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.

The judicial authority must infuse itself with a spirit of constitutionalism that depends upon an interpretive, non-technocratic hermeneutics and has emerged as a democratic counter weight to logics of multinational pharmaceutical capital. It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a commercial or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives.

There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics.

Instead we may have other innovative methods like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS.

The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlets question must be answered in favor of life.

(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)

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Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? - The Leaflet

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administrations (FDA) oversight of laboratory-developed tests (LDTs). The administration declared that LDTs, which are a subset of in vitro diagnostic tests (IVDs) developed and used in-house by clinical laboratories, would not be subject to premarket review by the FDA absent formal agency rulemaking. This announcement reversed the position that the FDA staked out in late February 2020, when it issued a guidance document for the industry on the development of IVDs to diagnose COVID-19.

The February guidance set expectations regarding the analytical and clinical validation of IVDs used to address the pandemic and included most complex LDTs intended to diagnose the disease. The FDA published a second policy in March allowing for independent authorization of LDTs by states and expounded on these policies again in May.

The FDAs oversight of LDTs in the context of COVID-19 promulgated with little fanfare given the exigencies of the pandemic represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades. Because the administration and the Department of Health and Human Services has now rescinded the FDAs prior guidance, laboratories must decide whether to voluntarily seek an emergency use authorization from the FDA for their LDTs, which would provide the tort protections associated with all such authorized countermeasures, or to proceed without it. Longer term, the future and degree of FDA oversight of LDTs will remain uncertain until either the FDA undertakes a formal rulemaking process or Congress takes legislative action.

IVDs are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, according to the FDA. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The FDA began regulating them as medical devices when Congress amended the Food, Drug and Cosmetic Act in 1976 to create the comprehensive regulatory scheme providing for the risk-based medical device classification system and premarket review process that exists today. Components of IVDs, such as antibodies, specific receptor proteins, ligands, nucleic acid sequences and other analyte-specific reagents, are also subject to FDA oversight as medical devices. Most of the hundreds of IVDs on the market today have been cleared by the FDA as Class II medical devices, which are sold to laboratories across the country.

The disconnect in this area is that, at the same time the FDA developed a robust regulatory process for premarket review of IVDs, it adopted a decidedly laissez faire approach to regulation of LDTs, a subset of IVDs that are designed, manufactured and used within a single laboratory for clinical use. The FDA perceived LDTs as low risk due to their limited number and primary use in rare disease contexts. Accordingly, LDTs were not subject to the agencys robust premarket evaluations of analytical and clinical validity. Analytical validity focuses on whether a test can accurately and reliably measure what it claims to measure, whereas clinical validity focuses on whether the measurement is predictive of a certain state of health. The result is a bifurcated market, in which IVDs developed for commercial sale are held to rigorous FDA standards while homegrown tests developed for the same uses inside the developers lab are not.

The FDAs oversight of laboratory-developed tests in the context of COVID-19 represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades.

Medical and technological advances over the past four decades have driven the development of LDTs to cover a wide range of conditions, including human papillomavirus, Lyme disease, whooping cough, certain cancers and heart disease. The growth of the LDT industry has led to concerns among stakeholders about whether current regulatory oversight of LDTs, led primarily by the Centers for Medicare and Medicaid Services (CMS), is sufficient to ensure their safety and effectiveness. Reports of inaccuracies in cervical cancer testing led to the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which extended federal regulations to all laboratories performing testing on human specimens for the purpose of diagnosis or treatment. Under the CLIA, CMS evaluates the analytical but not clinical validity of LDTs during accreditation surveys of laboratories. These surveys are conducted on a biennial basis, so it may take up to two years after an LDT has been offered for clinical use before its analytical validity is confirmed by regulators.

In July 2010, the FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying issues with several high-risk LDTs and hosted a public workshop to gather feedback from industry stakeholders. Four years later, the FDA issued draft guidance proposing a regulatory framework for LDTs. It followed up a year later with a report on 20 case studies of potential and actual patient harm arising from inaccurate or unreliable LDTs that supported the need for increased LDT oversight. Members of the lab and diagnostic industry pushed back against the FDAs new position, asserting the FDA had no right to regulate LDTs in the first place. They argued LDTs were clinical rather than medical devices and that regulation would constitute an intrusion into the practice of medicine. Industry stakeholders were also concerned that FDA oversight would stifle innovation, raise costs for laboratories and limit patient access to LDTs they deemed vital to public health.

In January 2017, the FDA announced it would not finalize the guidance and invited Congress to address the issue. To advance the discussion, however, the FDA published a position paper synthesizing feedback it received from stakeholders as well as its own views on appropriate oversight that would balance the need for innovation with the need for assuring the safety and effectiveness of LDTs. The FDA proposed an approach in which agency oversight would be phased in over several years based on risk. The proposal would grandfather tests already on the market and exempt from most oversight LDTs that are low risk or intended for rare diseases, forensic use, public health surveillance and so-called traditional tests that use components that are legally marketed for clinical use and whose output is the result of manual interpretation by a qualified laboratory professional, without the use of automated instrumentation or software for intermediate or final interpretation. All other tests, including modified versions of grandfathered tests, would be subject over time to adverse event and malfunction reporting, premarket clearance and approval, and CLIA-based quality requirements. The FDA reserved the right to take action against any LDT, even those exempted from the phased-in requirements, in the event of deceptive promotion or inadequate validation.

Many stakeholders interpreted the FDAs announcement as a retreat to the long-standing position of enforcement discretion while it turned the issue over to Congress to resolve. The reality was less clear, however, as the agency continued to assert its jurisdiction over LDTs in certain circumstances. In October 2018, FDA issued a guidance warning that many genetic tests on the market that claim to predict a patients response to specific medications had not been reviewed by the agency and might not be supported by requisite scientific or clinical evidence. In April 2019, the FDA issued a warning letter to Inova Genomics Laboratory alleging that its genetic tests, which were offered for the same purpose, were adulterated and misbranded, and posed a significant public health concern because they had not been adequately validated. Notably, the FDA rejected Inovas assertions that the company was operating within an LDT Exemption by explaining that no exemption existed and that the agency never created a legal carve out from its premarket review processes for LDTs. The agency also asserted that it retained the discretion to take action against LDTs when appropriate despite its long-standing policy of exercising enforcement discretion. The FDAs unpredictable approach toward LDTs left members of the lab and diagnostic industry unsettled and anxious about federal challenges to the legality of their tests.

Facing the COVID-19 pandemic, the FDA took another step toward more complete oversight when it included LDTs in its polices for other IVDs intended to diagnose the disease. The position was no doubt fueled by the FDAs desire to ensure a measure of analytical and clinical validity for all complex tests used to diagnose the disease, given the obvious exigencies and public health equities at issue. However, the Trump administrations August 19 announcement formally rescinds guidance and other informal statements from the agency concerning premarket review of LDTs. The move frees developers of LDTs to act without FDA pre-review, which offers a measure of clarity for the market but also triggers concern from public health experts who believe now is the time for more oversight, not less.

Against this backdrop, there may be greater pressure than ever on Congress to take up the issue. Lawmakers have made several attempts at determining the future of LDT regulation. A draft bipartisan bill released in March 2017 outlined a regulatory framework for LDTs based in part on a proposal by the Diagnostic Test Working Group, a coalition of industry stakeholders. After feedback from the FDA, lawmakers unveiled a new bill, the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act, in December 2018. On March 5, 2020, lawmakers introduced a revised VALID Act with bipartisan sponsorship.

The VALID Act would create a new regulatory framework to govern the development and use of all in vitro clinical tests (IVCTs), which would include both IVDs and LDTs. The proposal would replace the three-tiered system used to regulate other medical devices with a two-tiered system consisting of low- and high-risk tests (although the legislation would allow the FDA to develop special controls for certain high-risk tests, which could evolve into a third tier of moderate-risk devices). The legislation would require premarket evaluation and compliance with quality system regulations unless an exemption applied. Like the FDAs 2017 proposal, the act would exempt low-risk tests such as those intended to treat rare diseases and some LDTs that are already in use. Current LDTs not eligible for grandfathering under the act would be handled under special transitional provisions. The legislation also includes a precertification program intended to reduce regulatory burdens and provide priority review/breakthrough concepts. The program is modeled after those that exist today for other medical products to support expedited development and review of novel tests or tests intended to treat a life-threatening or irreversibly debilitating human disease or condition.

Whether and when Congress will act on the legislation is unclear. The current controversy surrounding COVID-19 testing is sure to put a spotlight on this issue, and the VALID Act has bipartisan support in committees of jurisdiction in both chambers. But the United States is heading toward another presidential election, and the current Congress has been notably partisan. The Medical Device User Fee Amendments must be renewed in September 2022, and that must-pass legislation is a likely vehicle for enactment of the VALID Act if it is not taken up beforehand. Some form of the legislation certainly could move in the next year, but the window is tight given the election and the other pandemic-related causes, which will take priority.

In the meantime, industry stakeholders should closely monitor developments in the LDT space. LDTs and related genetic tests play a significant role in health care decision-making, and a new regulatory framework will have major implications for the future of these products. But critical questions remain, including whether Congress will take action and whether the FDA will eventually act if Congress does not. Whether the FDA intends to respond to the August 19 announcement by initiating a rulemaking or formally modifying its 2017 position is unclear. The FDA likely will wait for the outcome of the election and take stock of its options then. Regardless of how, if at all, a more defined regulatory framework for LDTs ultimately crystallizes, the latest announcement makes clear that lasting guidance is necessary for all parties to navigate the world of LDTs with some measure of certainty, both during COVID-19 and beyond.

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FDA Oversight of Laboratory-Developed Tests Continues To Evolve - JD Supra