![]() Watermark App for Professional and Beginning Photographers □ No Ads□ No In App Purchases Add watermark to a photo or video. IWatermark+ Watermark Manager 5.2.0 APK Download - Android cats.flag_i_flag_as_inappropriate_a_div_section_div_div_div_class_o45e4d_c_wiz_jsrenderer_grlxwe_jsshadow_jsdata_deferred_i18_data_p_at_true_true_data_node_index_5_0_autoupdate_jsmodel_hc6ubd_c_wiz_section_class_hcyoxe_jscontroller_nkbkfd_header_class_div_class_vmq4uf_id_developer_contacts_heading_div_class_eamwib_h2_class_xfznbf_developer_contact_h2_div_div_jsaction_jibuqc_ptdedd_button_class_vfppkd_bz112c_lgbsse_yhy1rc_et1oj_mn1ivc_vxpof_jscontroller_sohxf_jsaction_click_coucgd_mousedown_ux7yz_mouseup_lbsd7e_mouseenter_tfo1yc_mouseleave_jywgue_touchstart_p6p2h_touchmove_fwunnf_touchend_yfqbxc_touchcancel_jmtrjd_focus_ahmuwe_blur_o22p3e_contextmenu_mg9pef_mlnrjb_flipzd_data_disable_idom_true_aria_label_expand_aria_controls_developer_contacts_aria_expanded_false_div_jsname_s3eaab_class_vfppkd_bz112c_jh9lgc_div_div_class_vfppkd_bz112c_j1ukfc_lhbdec_div_i_class_google_material_icons_vfppkd_kbdsod_w7a5qb_aria_hidden_true_expand_more_i_button_div_div_header_div_class_sfzrhd_jqsimf_role_region_id_developer_contacts_aria_labelledby_developer_contacts_heading_div_class_vfqhrf_bxir0d_div_class_vfppkd_wsjywc_vfppkd_wsjywc_owxexe_insagc_kc1dq_usd1ac_aan0dd_vvmwy_div_class_vfppkd_escbfb_jibuqc_jscontroller_tkhfxf_jsaction_click_coucgd_mousedown_ux7yz_mouseup_lbsd7e_mouseenter_tfo1yc_mouseleave_jywgue_touchstart_p6p2h_touchmove_fwunnf_touchend_yfqbxc_touchcancel_jmtrjd_focus_ahmuwe_blur_o22p3e_contextmenu_mg9pef_a_class_si6a0c_rrsxvb_target_blank_href_https_plumamazing_com_i_class_google_material_icons_j25vu_aria_hidden_true_language_i_div_class_pz8djf_div_class_xfvdsb_website_div_div_class_pseeg_https_plumamazing_com_div_div_a_div_class_vfppkd_fj5hab_div_div_span_class_vfppkd_bfbnve_bf1uub_nzp2ef_aria_hidden_true AppsįlagFlag as inappropriateDeveloper contactexpand_morelanguageWebsite
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![]() How should you organise the toys you are left with? MORE: 10 TIPS FOR ORGANISING YOUR KITCHEN ‘By donating and recycling toys beforehand, you’ll take away some of that pressure.’ ‘I have so many parents who feel stressed around Christmas and birthdays, because they think “What am I going to do with all this new stuff?”’ she says. It is well-documented that doing good things for others makes us happier in the long term, and it is never too early to start.’Īs for the regularity of clear-outs, Vicky says you should declutter toys ‘at a minimum’ twice a year, before Christmas and birthdays, which is when a new deluge of things arrive. By passing toys on, you will empower them, make them feel good about themselves and send an important message. ‘Discuss why other children might need their toys. ‘Involve them in the process of donating to charity’ says Kate. ‘Whenever I’ve worked with children, they’ve actually found decluttering an enjoyable activity, as it makes them feel important and responsible.’Īs well as helping children to realise that ‘stuff’ is fluid, and the positive impact of creating extra space, decluttering can also help little ones to embrace empathy. ‘The mum or dad will be very fearful about donating particular toys, because they think their child will be very upset, but when they actually ask the kid they are quite happy for it to move on to a new home’ says Vicky. Many parents are surprised to find how happily their offspring will get rid of items, says Vicky. What’s the best way to include your children in the decluttering process? This should give you a good indication of whether they will miss that toy should it make its way to the charity shop.Īfter you’ve done an initial declutter, culling any toys that are unloved, too bulky or not age-appropriate, you can do a second round of organising with your child, helping them to feel involved in the process. If you’re not sure how attached your child is to a particular toy, try putting it away for a while and seeing if your child asks for it, or instead just completely forgets its existence. MORE: 'A PRO ORGANISER CLEARED OUT MY WARDROBE AND THIS IS WHAT I LEARNED' If the toy is too old for them, it may cause frustration and won’t do anything positive for their self-confidence’ she says. ‘Playing with a toy aimed at younger kids may not encourage your child to learn. Kate also says you should think carefully about how age-appropriate each toy is. ![]() It’s better to pass on the toy to a child who will get joy from it’. ‘Don’t keep a toy because you somehow feel you should. ‘Just because an older sibling played in a certain way, doesn’t mean a younger one will’ she says. Kate Ibbotson of A Tidy Mind recommends observing your children closely as they play, to see which toys they actually enjoy playing with, and not assuming that because an older child loved a certain toy, you should keep hold of it for a younger brother or sister. Helen’s rule of thumb when it comes to getting rid of toys is ‘If they have grown out of it – pass it on to a younger child if it is worn out, recycle it and it if isn’t being used, takes up too much space or you have more than one, donate it’. So how can you choose which items to get rid of? There is also the concern that the kids themselves will kick off when they realise that a particular toy is no longer available – the possibility of a mega-tantrum is one no parent wants to face. Helen Sanderson, who is based in North London, offers personal organising services across London and the home counties, says ‘Parents associate toys with precious memories of their child growing up, and therefore find it hard to let go.’ Parents’ sentimentality, however, has a huge part to play in our inability to get rid of toys. MORE: 5 THINGS A DECLUTTERING EXPERT WOULD NEVER BUY ![]() ‘It’s a big problem because when children have far too many toys, they aren’t able to see and value each item it’s overwhelming for them, just as a wardrobe fit to burst is overwhelming for adults’ says Vicky. Toys are the enemy of organisation in many a home – professional organiser Vicky Silverthorn estimates that around 80 per cent of her clients name toys as a source of clutter they are constantly battling with. Why do we find it so hard to get rid of toys? So how can you declutter your kids’ toys without causing drama? We spoke to the UK’s top professional organisers to find out… ![]() ![]() The film, on the other hand, unites six of the original stories within an overarching plot that ends on a somewhat resolved note. A collection of short original horror tales written by Edwin Covarrubias. Director Cody Meirick Stars Alvin Schwartz R.L. In 2011, HarperCollins published editions featuring new art by Brett Helquist, causing mass controversy amongst fans of Gammell. It includes the author's family, scholars, folklorists, artists, and children's book authors such as R.L. Scary Stories to Tell in the Dark is a series of three collections of short horror stories for children, written by Alvin Schwartz and originally illustrated by Stephen Gammell. There were 9 other movies released on the same date, including The. Scary Story Podcast features scary stories about darkness, unexplained phenomena, ghosts, and the paranormal. Directed by André Øvredal and co-produced by Guillermo del Toro, Scary Stories to Tell in the Dark is based on Alvin Schwartz’s short story collection of the same name. A documentary about children's horror classic Scary Stories to Tell in the Dark. In the books, many of these stories end on a cliffhanger, leaving readers to decide on their own what horrors befall the characters after the words on the page stop. Scary Stories to Tell in the Dark was a Nationwide release in 2019 on Friday, August 9, 2019. ![]() The three Scary Stories books are comprised of folk tales and urban legends retold by Schwartz. That’s not to say that the movie won’t scare younger viewers who have never read the three Scary Stories books: Scary Stories to Tell in the Dark (1981), More Scary Stories to Tell in the Dark (1984) and Scary Stories 3: More Tales to Chill Your Bones (1991). But the most likely reason seems to be that our own imaginations often conjure up much more frightening imagery than anything that could be depicted on a screen. Maybe it’s that the movie is targeted toward a young audience and its filmmakers don’t want to inflict permanent trauma. Scary Stories to Tell in the Dark is an upcoming 2019 horror film directed by Andr vredal, based on the childrens book series of the same name by Alvin. Maybe it’s the fact that the generation that originally devoured this nightmare fuel is now fully grown and not as affected by ghost stories. Like the bestselling series of books that inspired it, Scary Stories to Tell in the Dark opens a creepy gateway into horror for younger genre enthusiasts. But while the original series - written by Alvin Schwartz and illustrated by Stephen Gammell - has been traumatizing kids for decades, the movie adaptation leaves a scare factor to be desired. Guillermo del Toro on ‘Scary Stories to Tell in the Dark’ guillermo del toro JGuillermo del Toro Explains Two New Scary Stories to Tell in the Dark Clips By Rachel. ![]() In inviting God into your life, you can find the strength for dealing with addiction, and overcome addiction. Invite Him in to your life by praying for His strength and wisdom, reading the Word, developing faith-based relationships, and asking for forgiveness if you fall back into old habits. Addictions may break us but Christ can put us back together. “Though your sins are like scarlet, they shall be as white as snow though they are red as crimson, they shall be like wool” (Isa. He also knows your sin and He loves you and is willing to forgive you anyway. He knows what it means to be tempted when Jesus fasted for 40 days and nights in the desert, Satan tried to tempt Him. The weight of addiction becomes lighter when you seek a relationship with Christ. For my yoke is easy, and my burden is light” (Matt. Take my yoke upon you and learn from me for I am gentle and humble in heart, and you will find rest for your souls. ![]() “Come to me all you who are weary and burdened, and I will give you rest. However, Jesus calls us to think differently. Though we may believe this in our hearts, our addictions may still make us feel unworthy of God’s love. The hard truth is we cannot overcome these unhealthy patterns on our own, but God can. Life then becomes an unending cycle of trying to overcome the pain but feeling powerless to change our circumstances. Once we are bound to the chains of addiction, feelings of emptiness, shame, brokenness, and loneliness quickly set in. We turn to sexual sin, substances, food, gambling, and other unhealthy activities as a strategy to overcome hardships, as antidotes for loneliness, and to fill other voids in our lives. The Bible counsels us to live a life of moderation and wisdom, but too often addictions place us on a path toward destruction and unhappiness. In this study, we examined the stiffness of pallia among amniotes: mice, turtles, songbirds, chicks, and ferrets. To understand the role of stiffness in organizing diverse brain structures, a comparative analysis of stiffness in several animal brains is required. However, it remains unclear how stiffness controls cellular behavior to form species-specific brain structures. Indeed, intensive research using atomic force microscopy (AFM) has revealed the spatiotemporal diversity and crucial roles of the mechanical properties of the extracellular environment, especially stiffness, in the developing central nervous system ( Elkin et al., 2007, 2010 Christ et al., 2010 Iwashita et al., 2014 Nagasaka et al., 2016 Thompson et al., 2019 Kjell et al., 2020). Migrating neurons respond not only to biochemical signals but also to mechanical cues from distinct extracellular environments on the way to their destinations ( Park et al., 2002 Huang, 2009 Honda et al., 2011 Long and Huttner, 2019). In the mammalian telencephalon, most glutamatergic projection neurons are born in the dorsal proliferative region and migrate into the cortical plate (CP) radially ( Nadarajah and Parnavelas, 2002 Noctor et al., 2004 Tabata et al., 2009), whereas GABAergic interneurons are born in the ventral proliferative region and migrate into the CP tangentially, resulting in a highly organized six-layered structure ( Anderson et al., 1997 Batista-Brito and Fishell, 2009). The mammalian neocortex (NCx) is originated in the most dorsal part of embryonic telencephalon ( Puelles, 2013 Nieuwenhuys, 2017). During brain formation, newly generated neurons in the proliferative region migrate to their final destinations. For instance, the mammalian brain has a six-layered structure, while the avian brains consist of compartmentalized nuclear slabs. These results indicate that species-specific microenvironments with distinct mechanical properties emerging during development might contribute to the formation of brain structures with unique morphology.Īlthough the vast majority of molecular machinery to generate neurons from progenitors are commonly conserved in amniotes ( Englund et al., 2005 Martínez-Cerdeño et al., 2016 Nomura et al., 2016 Turrero García et al., 2016 Yamashita et al., 2018), the alignment of neurons in matured brains exhibits remarkable diversity ( Medina and Abellán, 2009 Jarvis et al., 2013 Puelles et al., 2017 Cárdenas and Borrell, 2019 Pessoa et al., 2019). The embryonic chick and matured turtle pallia showed gradually increasing stiffness along the apico-basal tissue axis, the lowest region at the most apical region, while the ferret pallium exhibited a catenary pattern, that is, higher in the ventricular zone, the inner subventricular zone, and the cortical plate and the lowest in the outer subventricular zone. We found stage-dependent and species-specific stiffness in pallia among amniotes. We also measured brain stiffness in other amniotes (chick, turtle, and ferret) following glyoxal fixation. Based on this method, we found that the homologous brain regions between mice and songbirds exhibited different stiffness patterns. Notably, brain tissue fixed by glyoxal remained much softer than PFA-fixed brains, and it can maintain the relative stiffness profiles of various brain regions. A comparison of embryonic and juvenile mouse and songbird brain tissue revealed that glyoxal fixation can maintain brain structure as well as paraformaldehyde (PFA) fixation. For a systematic measurement of the brain stiffness of remotely maintained animals, we developed a novel strategy of tissue-stiffness measurement using glyoxal as a fixative combined with atomic force microscopy. To address this point, a comparative analysis of mechanical properties using several animals is required. However, little is known about the correlation between mechanical properties and species-specific brain structures. Recent studies have indicated that differences in the mechanical properties of tissue may result in the dynamic deformation of brain structure, such as folding. 3RIKEN Center for Biosystems Dynamics Research, Kobe, Japanīrain structures are diverse among species despite the essential molecular machinery of neurogenesis being common.2Developmental Neurobiology, Kyoto Prefectural University of Medicine, Kyoto, Japan.1Korea Brain Research Institute, Daegu, South Korea.Misato Iwashita 1*, Tadashi Nomura 2, Taeko Suetsugu 3, Fumio Matsuzaki 3, Satoshi Kojima 1 and Yoichi Kosodo 1* ![]() Starting in October, desktop warnings will pop up periodically to let you know the Drive uploader (which many simply call "Google Drive," hence the confusion) is being removed. While it retains most of the core functionality of Backup and Sync (file storage and syncing), it adds a few new features that will benefit businesses.įor example, File Stream users will be able to stream files on demand, access collaboration-friendly "Team Drives" (the settings for which can be controlled and changed at an administrative level) and sync individual files at will, while Backup and Sync only allows for the syncing of entire folders.Īnd if you're worried you'll forget to migrate over, Google has your back. The upcoming Drive File Stream works a bit differently. You simply upload your data and photos to the cloud, sync it with the desktop app, and call it a day. It functions in pretty much the same way as Drive. If you've never heard of Backup and Sync ( download here) prior to this announcement, don't worry. ![]() In a blog post, Google announced that starting December 11 file sync applications for Drive and Photos will lose official support and shortly thereafter, in March, they'll be removing the applications entirely. Meanwhile, enterprise users and G Suite customers will have access to a new upcoming "Drive File Stream" application which officially launches on September 26. Moving forward, users who had installed Google Drive and Google Photos on their computers to backup data will be using a new tool called Google Backup and Sync. The move comes as a result of Google's desire to combine all of their existing cloud storage solutions into one cohesive app, something they've wanted to do since July. Click the Google Drive icon: Click on Switch to one-way sync to switch to backup: Select an already-configured Google Drive account or click Add Google Drive to add a new Google Drive account. ![]() Google's cloud storage platforms – Google Drive and Google Photos – are getting new desktop clients. Here are step-by-step instructions on how to back up a single Google Shared Drive: Start the synchronization wizard to sync two cloud accounts. Users will simply migrate to the new "Backup and Sync" application. What is happening is that the old version of the Drive sync client called "Drive for Mac/PC" will no longer be supported. If you use Google Drive mostly through a web browser or Photos via Android, you probably won't notice any changes. On the Microsoft 365 confirmation page, choose Accept and start Outlook. On the setup confirmation page, choose Start Microsoft Outlook. Under Create a G Suite profile in Microsoft Outlook, leave the Import data from an existing profile check box cleared, and then choose Create profile. Google Drive and Google Photos are not going anywhere. Select your account, and then choose Allow. Update: On an earlier revision of this story, wording may have suggested that Google Drive was shutting down. ![]() Contents 1 Summary 2 Features 2.1 A Dark Fairytale Retold 2.2 Visual Concept 2.3 'Lying' Quests and Multiple Endings 2.3.1 Weapon-Making System 2. Lies of P currently has no set release date but is planned to release sometime in 2023 for the PlayStation 5, PC, Google Stadia, and Xbox Series X. Lies of P is an action souls-like game set in a dark Belle poque world. Lies of P is currently being developed by South Korea-based Round 8 Studios, who also worked on the MMO Bless Unleashed. It will be published by Neowiz, which also published DJMAX RESPECT back in 2018. You can check out the official announcement trailer below: It’s likely that this special skill system may be tied to defeating enemies and gathering parts, as Geppetto does in the trailer. 32 likes, 1 comments - QFX Cinemas (qfxcinemasofficial) on Instagram: 'Full of incredible action where you will never ever be able to take your eyes away from screen. The mechanical arm seems to be made using the same technology as the horrible creatures in the church. In the trailer, we see that Geppetto has equipped Pinocchio with a mechanical arm. Players will be able to customize their weapons and combine weapons, and the developers have urged players to research and test accordingly.Ĭustomization isn’t limited to weapons, though: as a bionic boy, Pinocchio will also be capable of changing parts of his body to gain new skills. Lies of P will also reportedly feature a “deep combat system.” Some of the mechanics mentioned are a weapon-making system, teased towards the very end of the trailer. According to the steam page, the city of Krat has been lost to humanity and is now a “living hell filled with unspeakable horrors.” A few seconds earlier, we also see large feather-covered pods that dripping with the strange liquid. Inside the church, we also see two damaged mechanical creatures that are leaking a similar black goo. On that note, what do you think about Lies of P reportedly coming to Xbox Game Pass on day one of launch? Let us know in the comments section.A dead body in a top hat also sits in front of the church, and a black goo-covered rat crawls out of the body’s mouth. This is the limited information we have for now. Although this has to be considered that this is not official news and can be proven wrong at any time, we advise you to take this news with a grain of salt. We are excited for Gamescom 2022, and we hope this leak is accurate and everything goes according to plan. Gamescom 2022 will take place from Wednesday, August 24, to Sunday, August 28, and because both PlayStation and Nintendo are skipping it this year, Xbox will be the only significant console rival. Thus, we may anticipate its announcement at Gamescom 2022. Lies of P is one of the third-party studio titles listed on the Xbox booth that are available on Game Pass from Day One. In the below list of games from third-party studios, we will find the most anticipated games like A Plague Tale: Requiem coming to Xbox Game Pass Day One launch. The plot is similar to the story of Pinnochio. The words decoded from the morse code are from Kanye West’s song “Pinnochio Story,” which could point towards “Lies of P” because the game is anticipated to be on the upcoming Gamescom. Snitch always finds a way to make his leaks interesting, and this time he encoded the leak into morse code. The tweet contains a video that is encoded in morse code, but when it is decoded, the sentence that follows is revealed: While we wait for Gamescom 2022 to reveal more information about the game, Snitch, a well-known leaker who has earned our trust thanks to his accurate leaks of Hollow Knight Silksong and The Last of Us Part 1, has once again hinted in a tweet that appears to be Lies of P coming to Xbox Game Pass day one launch. However, it was revealed recently that the game would be present at Gamescom 2022 in the Xbox booth. ![]() Lies of P was first announced in May 2021 since then, not much has been heard about it. ![]() In Lies of P, humanity is lost in a once-beautiful city that is now overrun by horrible horrors, and, like in the real narrative, the player must lead Pinocchio on his quest to become human. Pinocchios lying is one of the most important experiences that youll have. ![]() During the journey, youll be put in a situation where lying is needed to protect yourself or others. Play as Pinocchio and solve the mysteries and disaster that happened in the city of Krat. The well-known Pinocchio tale served as the game’s inspiration. Lies of P is an Action RPG based on the classic tale of Pinocchio. Lies of P is an action souls-like game set in a cruel, dark Belle Époque world. ![]() They are any type of image that is put on the wall and can be used as a background image or to add some Personality to an office. Wallpapers are a type of photo wallpaper that can be found in many different places online. Purple Flowers Wallpapers | HD Wallpapers | ID #5518 # A lot of people find cool wallpaper goes well with dark walls because it makes everything pop together better.Ĭool wallpaper is often affordable and easy to get installed on your wall! This can make you feel more relaxed and allow you to relax more when you’re home.Ĭool wallpaper is perfect for bedrooms and other areas that need some lightness in the space. When you have a wall full of cool wallpaper, it can help create a feeling of chilled outness in the room. Here are some benefits of using cool wallpaper:Ĭool wallpaper can add an air of chill. There are a variety of cool wallpaper options available, so it’s important to find the right one for your needs. It can add some visual interest and make a home feel more inviting. Wallpaper can be a great addition to any room. Here you go: Battlefield 4 Game Wallpapers | HD Wallpapers | ID #12913 #īattlefield game wallpapers bf4 pc 1080 1920 games battle kjell 1280 recker. ![]() We have 13 Images about Battlefield 4 Game Wallpapers | HD Wallpapers | ID #12913 like Lewis Aurora – Bing Wallpaper Download, Battlefield 4 Game Wallpapers | HD Wallpapers | ID #12913 and also Purple Flowers Wallpapers | HD Wallpapers | ID #5518. ![]() Looking for Battlefield 4 Game Wallpapers | HD Wallpapers | ID #12913 you’ve came to the right web. Some people find that prints or photos will not show as well on high-quality wallpaper than others. Lastly, the quality of the wallpaper should be considered. However, if your walls are light brown or white, then a darker color may work better. If you want a wallpapers to be noticed, you’ll want to choose something that complements your home’s natural colors. The second thing that you need to consider is the color of your home’s walls. A wallpaper with a large image will not fit well in a small room, and vice versa. The first and most important factor is the size of your room. When it comes to wallpaper, there are a few things that you need to take into account before making your decision. How to Choose the Right Wallpaper for Your Home: Factors to Consider They have distributed thousands of posters pitching the “world-famous happiness author” and his free lectures. “I wouldn’t miss one for the world.”īut this weekend, for the first time in seven years, the New Age Mohammed is coming to the mountains, and his students are busily paving the way for his arrival. “I’ve been going to the Boulder City gatherings every month for three years,” Etheridge says. At a banquet, they put on skits and dances, and often are led in merriment by the most celebrated among them, Desi Arnaz Jr., who credits Howard with helping him lick his drug and alcohol problems. There, the 70-year-old Howard exhorts them and other followers from around the United States to deeper levels of introspection and greater heights of happiness. Spirituality Expert Tom Russell Quick Facts Main Areas: Practical Spirituality.Once a month, Etheridge and dozens of others convoy seven hours across the desert to Boulder City, Nev., Howard’s home and the headquarters of his “Success Without Stress” program. Many people wish to know how to apply the wonderful spiritual information they've gleaned over the years. How do you cross the bridge from theory to mastery? Our focus is a special use of daily life experiences to empower this transition.īest Sellers: SuperWisdom - Seven Vital Secrets for a Rich and Purpose-Filled LifeĬareer Focus: Host of "Time Out for Truth" Podcast and Director of the SuperWisdom Foundation VERNON HOWARD SUPERMIND PAGE HOW TO Tom Russell is the author of "SuperWisdom - 7 Vital Secrets for a Rich and Purpose-Filled Life." He is the director of the SuperWisdom Foundation, editor of the SuperWisdom Ezine which is enjoyed by thousands of subscribers in more than 30 countries, and the host of the new podcast "Time Out for Truth." Tom has been interviewed on more than 200 radio and TV talk shows and presents stress management presentations to corporations and organizations throughout the Southwest United States. Tom's work has been influenced dramatically by the teachings of author Vernon Howard, with whom he studied for twelve years. Howard's inner development books are a brilliant synthesis of the great truths of the ages. They have been translated into several foreign languages with a readership of at least 8 million people. Question: The "True Self" is often discussed in spiritual literature. Reply: Like a fresh geyser on the ocean floor, your True Self is the inner location from which all vitality flows. Underwater geysers are very rare places in nature and great quantities of life are found there. Likewise, spiritual ideas of tremendous power and clarity are hovering around our Essence, but we are asleep to this paradise. It is the purpose of all authentic spiritual teachings to awaken us to the treasures we already possess within. Question: So many things, both inwardly and outwardly, are clamoring for my attention. ![]() Toms work has been influenced dramatically by the teachings of author Vernon Howard, with whom he studied for twelve years. Reply: No matter how severe the noise, you can touch your True Self in the midst of it. Howards inner development books are a brilliant synthesis of the great truths of the ages. There is an old movie with a good scene in it. The singing started softly but grew in intensity as people joined in.īack in the Nazi days a man stood up in a restaurant and started singing his party's song. He sat there with his arms crossed and with a firm look on his face. Likewise, be resolute in your determination to abide in the wisdom and silence of your intuitive self. If we allow our attention to wander in the slums of preoccupation, we absorb the contents of the slums. ![]() ![]() If we regain our power of attention and focus on higher themes, we blend with the higher themes. ![]() We must resolve to reclaim our power of attention from flighty mental pursuits. ![]() If something terrible happened to a woman more than a year after implantation, it wasn’t included. If something terrible happened to a woman but the investigator didn’t think or didn’t want to say it was “possibly” related to the Essure-such as autoimmune disorders and inflammatory reactions to the toxic metals in Essure-then it wasn’t included. Look carefully at page 8 of that summary of Essure safety data: that table of “adverse events” only includes those events the clinical trial investigator (who was paid by the manufacturer) said were “possibly” related to the Essure and only those events that occurred in the first year after the implantation. ![]() Yet, even the data taken at face value isn’t much: Essure was approved and sold to the public after a single “Phase II” clinical trial (a trial designed mostly to look at whether the implant can function, rather than if it is safe) of 227 women and a single “Phase III” clinical trial of 518 women. ![]() As The Bleeding Edge points out through interviews of clinical trial participants, this data was inaccurate, and the researchers routinely changed the participants’ answers to make the device look safer than it was. But the FDA doesn’t see things that way, and so routinely allows inherently risky devices to glide through the 510(k) loophole without any studies.Įssure went through this “PMA” process, which, as we’ll discuss in a minute, is often referred to as “rigorous.” You can read the “safety and effectiveness data” used to approve it. As the FDA says, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” We can already see one obvious problem: there’s no doubt a complete hip replacement (like the DePuy ASR) or the surgical implantation of a foreign object (like transvaginal mesh) “present a potential, unreasonable risk of illness or injury,” and so should have to go through the premarket approval process. If a medical manufacturer doesn’t want to or can’t use the 510(k) loophole, then they go through the “premarket approval” (“PMA”) process for “Class III” medical devices. The DePuy ASR hip implant used never-before-tested components, and transvaginal mesh was used for a never-before-tested purpose-yet both sailed through the 510(k) loophole. ![]() The FDA’s interpretation of “substantial similarity,” however, has gone so far off the rails that the FDA regularly approves medical implants with different designs, different materials, and different purposes. Most medical devices need not undergo any testing because they are approved under a provision that only requires the manufacturer to show “substantial similarity” to some other approved medical device. The Broken Regulation Of Medical DevicesĪs The Bleeding Edge points out, one key problem is the 510(k) loophole, which I’ve written about many times before, and which the Institutes of Medicine long ago recommended be abolished. Essure was just one part of a broken regulatory system and a corrupted market, and medical device companies often lobbying Congress to make it even worse. If no one ever watched The Bleeding Edge, the film would still be a remarkable success: soon after it premiered, Bayer announced it will discontinue sales of Essure.īut everyone should watch it. I know these awful products well most of my law practice is representing victims of medical devices and pharmaceuticals. The Bleeding Edge, a documentary just released on Netflix, details the many problems with medical devices today, with an emphasis on the suffering of thousands of people due to Bayer’s Essure contraceptive, DePuy’s ASR hip implant, Johnson & Johnson’s transvaginal mesh, and the Da Vinci surgical robot. The medical devices which are tested can pass with a minimal showing, and Congress passed a special law that says that this minimal showing is enough to shut the courthouse doors on victims. Most medical devices aren’t tested with clinical trials. Yet, those examples above describe the state of the $156 billion American medical device market. What about a car that had just one crash test, at low speed, and Congress had passed a special law making it impossible for anyone to sue the car company, so the company couldn’t be held responsible for people’s injuries? Would you put your family in one? Imagine if lights, kitchen equipment, and home electronics didn’t need to be tested for electrical shock and fire hazards, and that no one ever certified that the devices were safe. |
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