Delhi may start tele-med services for other patients
FDA Authorizes Use of Plasma From Recovered Patients to Treat COVID-19
(WASHINGTON) — President Donald Trump on Sunday announced emergency authorization to treat COVID-19 patients with convalescent plasma — a move he called “a breakthrough,” one of his top health officials called “promising” and other health experts said needs more study before it’s celebrated.
The announcement came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.
On the eve of the Republican National Convention, Trump put himself at the center of the FDA’s announcement of the authorization at a news conference Sunday evening. The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling the disease. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, said: “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
But Trump had made clear to aides that he was eager to showcase good news in the battle against the virus, and the timing allowed him to head into his convention with momentum. He and aides billed it as a “major” development and used the White House briefing room to make the announcement.
Trump also displayed some rare discipline in the evening news conference, sticking to his talking points, deferring to the head of the FDA, Stephen Hahn, and only taking three questions from reporters.
The White House had grown agitated with the pace of the plasma approval. The accusations of an FDA slowdown, which were presented without evidence, were just the latest assault from Trump’s team on what he refers to as the “deep state” bureaucracy. White House chief of staff Mark Meadows did not deal in specifics, but said that “we’ve looked at a number of people that are not being as diligent as they should be in terms of getting to the bottom of it.”
“This president is about cutting red tape,” Meadows said in an interview Sunday on “This Week” on ABC. “He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering.”
During Sunday’s 18-minute press conference, Trump said he thought there had been a “logjam” at the FDA over granting the emergency authorization. He alleged there are people at the FDA “that can see things being held up … and that’s for political reasons.”
Dr. Joshua Sharfstein said the statement, and Hahn’s silence while Trump said it, “was disgraceful.”
“The FDA commissioner basically allowed the president to mischaracterize the decision and attack the integrity of FDA employees. I was horrified,” said Sharfstein, a vice dean at John Hopkins University’s school of public health who was a top FDA official during the Obama administration.
“This is a promising therapy that has not been fully established,” he said
The push on Sunday came a day after Trump tweeted sharp criticism on the process to treat the virus, which has killed more than 175,000 Americans and imperiled his reelection chances. The White House has sunk vast resources into an expedited process to develop a vaccine, and Trump aides have been banking on it being an “October surprise” that could help the president make up ground in the polls.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted.
He continued: “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover. But it wasn’t considered proof.
More than 70,000 patients in the U.S. have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.
But it wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of an FDA program designed to speed access to the experimental therapy. That “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.
Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given ‘high-titer’ convalescent plasma containing higher concentrations of antibodies. They were then compared to similar patients who were given lower-titer plasma. The findings suggest deaths were 35% lower in the high-titer group.
There’s been little data on how effective it is or whether it must be administered fairly early in an illness to make a significant difference, said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University.
Aiming to ward off a possible a run on convalescent plasma after the announcement, government officials have been working to obtain plasma and to team with corporate partners and nonprofit organizations to generate interest among previously infected patients to donate.
Hahn, who called the development “promising,” said Trump did not speak to him about the timing of the announcement. He said “this has been in the works for several weeks.”
But some health experts were skeptical. Benjamin Corb, of the American Society for Biochemistry and Molecular Biology, called it “conspicuous timing.”
“President Trump is once again putting his political goals ahead of the health and well-being of the American public,” Corb said.
Rigorous studies are under way around the country, comparing similar patients randomly assigned to get plasma or a dummy infusion in addition to regular care. But those studies have been difficult to finish as the virus waxes and wanes in different cities. Also, some patients have requested plasma rather than agreeing to a study that might give them a placebo instead.
Former FDA commissioner Dr. Scott Gottlieb dismissed the suggestion of a slowdown.
“I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients,” Gottlieb told CBS’s “Face the Nation.”
Trump, in news conferences, “has made all kinds of therapeutic suggestions” that have not proven to be supported by science — and are even dangerous, Schaffner said. That includes statements about the possible value of treating COVID-19 patients with ultraviolet light and disinfectant. Trump reportedly also recently became enthusiastic about oleandrin, a plant extract derived from a toxic shrub that scientists immediately warned against.
But the president is perhaps best known for his early and ardent embrace of the malaria drugs hydroxychloroquine and chloroquine.
Earlier this month, Hahn emphasized that routine evaluation procedures will remain in place to evaluate COVID vaccine candidates.
“I think this administration has put more pressure on the Food and Drug Administration than I can remember” ever happening in the past, Schaffner said.
“Everybody is just a little bit nervous,” he said.
___
Stobbe reported from New York.
5 Mindful Recovery Steps for Self-Observation
In early recovery, there is value in filling your space and time with meetings and various distractions to fill in the space that was once consumed with substances and addictive behaviors. There is also value, at some point, to create unfilled space for your presence and attention. Creating space to be present for your presence is a key to sustainable long-term recovery.
Creating Space vs Filling Space
The practice of mindfulness; being there, being present, paying attention, and learning to be there for yourself starts with the process of letting go. Letting go of substances and addictive behaviors is a great start. The beginning steps of letting go are important. If you plan to begin a formal sitting meditation practice or go on retreat, the same is true; we begin to clear our schedules. We let go of our usual doing in order to create space for something different.
Mindfulness and meditation are practices of letting go in order to create space for your attention.
If you are filling up recovery time with meetings and the doing of “stepping”, you can begin taking your recovery a step further by creating space to observe your being, by yourself. You can learn to be there for yourself, to witness and give attention to the happenings of your mind, your body, and your emotions.
Creating Space for an Inner Life
There is a lot of value in observing your inner life. You may discover the real hunger, the real need within you that is reaching out in an addictive way. This in and of itself could change the course of your entire life.
Creating space for yourself, to give attention to your inner happenings, is to begin healing yourself. Attention leads to connection; connection to regulation; regulation to order; and order to ease (as opposed to dis-ease), or more colloquially, to health.” [1]
Learning to Observe
Learning to observe yourself is much like bird watching. Even if you’ve never been bird watching, it’s not hard to figure out that all you need is some space, silence, and stillness (and birds). If you can observe a bird, you can observe yourself.
The mindfulness approach is learning to be there, just as you are. Like bird watching, we don’t try to change anything, we simply observe. Being there for yourself with attention, listening, watching, and observing — observing our behaviors and mindsets — and that observation can lead to answers and solutions that drive addictive patterns.
We give our attention away every day: to everybody and everything. We are listening, watching, observing: we watch television, we observe other people, we listen to others. We know how to give attention, we are simply not used to giving it to ourselves.
To give yourself attention is one of the most loving, caring, interesting, brave things you can do. Why brave? Because not only will you be giving attention to the good, you will also be attending to the bad and ugly.
Giving Attention
We can begin giving attention by listening. Silence is needed to listen and to hear your inner happenings. This is how you get to know the different parts of yourself; the parts of you that want to quit the addiction and the parts of you that don’t want to quit. You will get to hear the parts of you that fuss and scream that it’s too hard, and get to know the parts of you that resist.
Giving attention to the parts of you that resist is of utmost importance for long-term recovery success. There may be parts of you that are resisting a new path, a different life, more opportunity, improved health, and better relationships. All the good things you want in life can be the very things you resist.
Being with Resistance
The mindfulness approach to resistance is not to beat it, shame it, punish it, strong arm it with willpower, or distract. We create space for it. We get to know it. We give it attention by looking, observing, being with, and listening; like bird watching. If anything, we come up closer, quieter, and gentler to our resistance.
Relapse and continued addiction is sometimes less about wanting to stop. You know you want to stop.
Not many people consciously choose to suffer. To ask if we want to quit the object of suffering can be an easy “Yes.” The real question is not if we want to quit, but why are we resisting things like a new path, a different life, better opportunities, improved health and relationships, and real success?
This is getting to the deeper parts of ourselves. This is the good stuff; to start observing that which is unconscious within us can create powerful, long-term changes in our lives.
The very things we so desperately desire can feel unsafe because they are unknown and unfamiliar. The path to a better life may come with thoughts that we have to walk it alone, and in many ways, this can be true.
Braving a Better Life
The inner walk of self-observation is a journey solely for you. Braving your inner wilderness is meant to be your journey alone because no-one else is in there with you, but once you start walking around in there, you will soon discover you are not alone.
With some space, silence, and stillness, you can also observe the part of you that wants to help. The you that wants to help you. This is where you start learning how to help yourself. You can learn to help the part of you in resistance. The two of you can have a conversation. It could be the most fascinating and enlightening conversation you’ve ever had.
The Inner Laboratory
Jon-Kabat Zinn teaches that with a mindfulness practice, we become the scientists of our own inner laboratory. Just like a good scientist, we can observe our inner formulas. We can observe which thoughts, emotions, and behaviors that create disaster and explosions in the lab. From this observed data, we have more choices to explore new chemical and behavioral compounds that create different outcomes.
The mindfulness approach is more than a practice of external abstinence; it’s a practice of observing our inner compounds and experimenting with them. It’s a practice of self-discovery and self-observation, which are both elements for self-healing and sustainable recovery.
A 5 Step Practice for Self-Observation
In Mindful Recovery:
- Let go of the usual doing.
- Create unfilled space for silence without distractions. This can be at home, in a chair, on the porch. Keep it simple. If sitting still feels like too much to begin with; a quiet walk without distractions will work.
- Do nothing but be there to observe your thoughts; listen, feel, pay attention. Observe your thoughts, emotions, and behaviors over the past few days. Imagine that you are the bird you have been watching the past few days.
- Collect data from your observation. Did you get any insights?
- Do you want to do anything with the insights? Does anything need to be done?
Notes: 1. Jon Kabat-Zinn, Full Catastrophe Living; Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness (New York: Bantam Dell, 1990), 228.
The post 5 Mindful Recovery Steps for Self-Observation first appeared on World of Psychology.
After the Fight — Repairing Your Relationship
Emotions run high during a fight. Yet sometime later, we may have forgotten what triggered our rage in the first place. We recall fighting, but what was it about anyway?
Lauren later remembered the details about a fight with her husband because she’d written about it in her journal. “Though I don’t like the word ‘fight,'” she said, “because we don’t hit or anything like that. But I was so furious it felt like a fight.”
The Fight
Lauren had told Jim a number of times not to interrupt her while she was praying. Praying was a sacred time for her, like meditation. Whatever he wanted to say could wait. It was never an emergency. More likely, he just wanted her to stop right then and listen to him. Often, he hoped she’d hurry up because he wanted her attention very soon. The last time that happened, Lauren tried to ignore him but was too upset to focus. When finished, she approached Jim, who was now in the kitchen washing dishes. “I’ve told you more than once not to interrupt me when I’m praying,” she said irritated.
“There’s no law that says you can’t talk to someone who’s praying,” he shot back.
“I still don’t want you to interrupt me,” she said, taking in his arrogant tone.
Then she noticed that Jim was using a dish soap said to contain toxic chemicals instead of the safer one she bought to replace it. She reminded him to use the new dish soap, which still had enough left for the job.
Jim’s response was an angry, “Okay, but when this (the safer soap) is empty, I’m going to use the other one.
How dare he threaten me? thought Lauren. He should know that I buy back up supplies. She said she was upset with him for using that tone.
Jim’s response: “I’m sorry that you feel upset.”
Lauren tells herself, “That’s not an apology. His ‘sorry’ means he doesn’t think he did anything wrong; he just wishes I wasn’t upset.”
Lauren Takes Time to Reflect
Lauren had to get away. Outside, she walked around her neighborhood. Her first thought was that Jim should sleep in the den that night. Cuddling with him in bed was usually so comforting, but now she didn’t want him close.
As Lauren continued to walk, her breathing slowed down. She felt calm enough to use the self-talk communication technique she’d learned from her therapist. This five-step process usually helped her move from angst to a more accepting attitude. Now, she did each step:
- What am I telling myself? “He’s a jerk and doesn’t love me.”
- Is my message to myself helpful? “No, it makes me feel like he doesn’t care about me.”
- Where is my message coming from? “It’s coming from my tendency to catastrophize and fail to look at the big picture. I feel like I can’t have anything to do with him because he’s acting short-tempered and unapologetic.”
- What more helpful message can I give myself? “Most of the time, Jim’s a wonderful husband. He’s usually kind, helpful, and respectful. He’s not perfect, and I’m not either. He tolerates my shortcomings. I want to accept him as a whole package, with many fine traits and also some faults.”
- What is my action plan now? “I’ll sleep in the bedroom with him but probably not cuddle. I’ll see how I feel. I think I need a real apology before I can let down my guard.”
Lauren felt better after clarifying her thoughts and feelings. She also turned to her religion’s teachings, which stress the importance of creating fulfilling marriages. “G-d is helping me get outside of myself, view things more objectively. I want a real apology, but I do need to view this incident as a small piece of the big picture, which is quite good.”
Thinking it over, she felt more understanding of why Jim was so short-tempered. He sometimes gets that way when he’s hungry. Also, he hates washing dishes by hand. The dishwasher broke, and the replacement hadn’t come yet. So Jim was already in a bad mood when she criticized him for using the wrong soap.
None of these things excuse his rudeness, Lauren thought, “but understanding helps me to feel like our fight was minor in the grand scheme of things.”
When Jim cautiously approached her for their usual bedtime good-night hug that night, he looked at her tentatively. As Lauren opened her arms, she saw relief in his smile.
Both knew they were on the road to recovery. The “talk” came in the morning.
When it did, Lauren said, “This isn’t about whether or not a rule exists about interrupting someone’s prayers. It’s about me wanting to feel respected by you. Please don’t talk to me while I’m praying, because this is what I want.”
Jim gave a real apology for his harsh tone. He also agreed to avoid talking to Lauren while she was praying.
A few days later, Lauren had to wrack her brain to remember what they’d fought about.
Good Marriages Have Unresolvable Conflicts
If you’re in a good marriage, you might relate to the experience of forgetting what you were fighting about soon after making up.
Psychologist John Gottman’s marriage research has shown that a whopping 69% of relationship conflicts are about perpetual problems. All couples have them, and they don’t go away.
While cooling off from their fight, Lauren recognized two of their unresolvable conflicts: she practices their religion more strictly than Jim, and he cares less about details than she does, like which dish soap to use.
Couples Who Succeed Manage Differences Well
Gottman concludes that instead of solving their perpetual problems, what seems to be important is whether or not a couple can establish a dialogue about them, which means address their issues respectfully. If they cannot create such a conversation, the conflict becomes gridlocked. The gridlocked conflict eventually leads to emotional disengagement.
Because Lauren and Jim were able to talk about their conflict constructively, they were able to repair the breach and resume a loving relationship. They managed their conflict successfully, restoring faith in each other.
Each time we manage conflict well, we gain trust in our ability to deal with future ones successfully. A happily-ever-after marriage? Not the fairy tale false notion, but the real-life one: conflict is normal in marriage and other close relationships.
Proactive Practice Keeps Love Flowing
Even though some conflict is inevitable and healthy, couples who are proactive can vastly decrease the time spent around fighting. By holding a weekly marriage meeting, partners increase intimacy, teamwork, and smoother resolution of issues. Marriage Meetings for Lasting Love tells step by step how to hold these short, gentle conversations.
Spouses are not going to see eye to eye on everything. Yet they can learn how to repair the relationship after a quarrel. They can also be proactive in increasing intimacy and preventing misunderstandings and grudges.
As Mignon McLauchlin says: “A successful marriage requires falling in love many times, always with the same person.”
The post After the Fight — Repairing Your Relationship first appeared on World of Psychology.
It's crucial to get a flu shot this year amid the coronavirus pandemic, doctors say: experts recommend older people and those who are immunocompromised wait until mid-fall to get their shots so it lasts throughout the entire flu season.
It's crucial to get a flu shot this year amid the coronavirus pandemic, doctors say: experts recommend older people and those who are immunocompromised wait until mid-fall to get their shots so it lasts throughout the entire flu season.
 |
submitted by /u/shallah [link] [comments] |