Off Label Promotion Profitable Health Jeopardizing Act...

Off-label promotion: profitable health jeopardizing act of defiance or costly freedom of speech? INTRODUCTION Over the years there is the discussion on the nature of off-label promotion. Promotion for an unapproved by the Food and Drug Administration usage of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions. On the other hand, off-label promotion is deemed to be a constitutional right protected by the First Amendment. Numerous debates, lawsuits and court rulings still don’t clear up the dilemma of off-label promotion. HISTORY OF OFF-LABEL PROMOTION REGULATIONS Off-label use of drugs and medical devices is common practice in the United States.†¦show more content†¦Another law that imposes liability on healthcare manufacturers is the False Claim Act also known as Lincoln Law. Initially, the law was applied to people who defraud federal programs but in the late 90s the Act commenced to be applied to frauds associated with the promotions of the healthcare goods. The first recognition of off-label promotion was made in 1996 when Franklin v. Parke-Davis lawsuit was filed. Dr. David Franklin filed the False Claim Act case based on his concerns on his former employer’s, pharmaceutical company Parker-Davis, off-label promotion of anti-epileptic drug Neurontin. The proposed claim that off-label promotion complies with the False Claim Act was new and controversial. It took 8 years of legal disputes to attain equally beneficial settlement of $430 million in fines and penalties. The Franklin v. Parker-Davis case set a precedent for nume rous off-label promotion cases, which still remain urgent matter for both lawsuits and public debates. CLAIM ONE Off-label promotion is law-prohibited action, which is used to increase sales profits. The numerous cases were filled against the giant multinational corporations with allegation in fraud, kickbacks, noncompliance with established laws and regulations. Companies tend to commit the same mistakes year after year despite the existing precedents. What motivates manufacturers to take illegal actions? Why

Correlation between Social Strata and Levels of Stress

There is empirical validity to the hierarchy and stress approach; Marmot et al. (1991) explore the relationship between social hierarchy and health the seminal Whitehall civil servant study. Marmot et al. (1991) found that those who held higher occupational prestige had better health outcomes and lower risk of mortality than peers in lower occupational strata. One explanation was that those in lower social strata experienced greater daily stress than their peers (Marmot, 2004). This has been extended beyond occupational hierarchies; experiencing racism—the result of a social hierarchy patterned around race/ethnicity—has been linked to poorer health outcomes for racial/ethnic minorities (Gee, 2002; Jackson et al., 1995; Karlsen Nazroo, 2002; Paradies, 2006). The literature confirms that occupying lower social strata and experiencing high levels of stress is deleterious for health (Aneshensel, 1992; Barr, 2008; Karasek et al., 1988; Meyer, 2003), promoting the core tenan t of fundamental cause theory: social conditions cause health outcomes. Evidence of Fundamental Causes—The case of SES Socioeconomic status is one way individuals are socially stratified. In Western society, we’ve created a social hierarchy surrounding wealth, occupational prestige, and education. Although there are multiple ways of hashing out social categories based on SES, it is clear that residing in lower strata of this particular social hierarchy is deleterious for health. To assess whether or not SESShow MoreRelatedKiryl Slizheuski. Student Number Here. Class Section Here.1675 Words   |  7 Pagespursuing this pressing question (Boeri 107). 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Rainbow by Kesha free essay sample

Heartache leaks in from every corner of the world, tipping life into all shades of gray. Living seems pointless until the wisps of a million different colors spill out from the horizon—at the end of every storm always comes a rainbow. After five years of being legally barred from producing music, Kesha grows despite her painful past, and she returns with Rainbow, an album that radiates resilience. Kesha uses Rainbow to overcome the many difficulties she has faced in the past few years. In 2014, Kesha sued Dr. Luke, her former producer, for allegedly abusing her sexually and emotionally throughout their many years of success in the music industry. Kesha was previously known as Ke$ha, a famous, perky, and extraordinary pop star with hit singles such as â€Å"TiK ToK† and â€Å"We R Who We R† that dominated global music charts and dance floors. However, in Rainbow, Kesha sings about more than partying and having fun. We will write a custom essay sample on Rainbow by Kesha or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page Now, her songs prominently display her feminist views, courageous responses to traumatic experiences, and incredibly personal promises to heal. In an interview with Good Morning America, Kesha said, â€Å"I think this record has quite literally saved my life. I hope you guys like it, I hope you can hear it, and I hope it helps people.† The Kesha who produced the pop-rock album Rainbow is refreshingly raw; her current music is crafted from emotional lyrics and deep instrumentals, but the upbeat party songs that helped her climb the charts in previous years still remain in many of her tracks. The record’s name originates from the song â€Å"Rainbow,† an optimistic track that starts out with simple piano chords that later blend into the spirited voices of an orchestra, which produces strands of hopeful energy within the motivating lyrics. The lines that define Kesha’s bravery and strength are, â€Å"I cant lose hope, whats left of my hearts still made of gold.† In â€Å"Learn to Let Go,† a strong drum beat complements the occasional strum of an electric guitar. â€Å"Let ‘Em Talk† features Eagles of Death Metal, an American rock band who brings fruity guitar riffs to the lively rhythm of this track. The acoustic guitar chords that repeat in â€Å"Godzilla† help p ortray the whimsical, innocent nature of the song, while â€Å"Woman† utilizes the sassy sound of horns to accentuate Kesha’s fun, wild voice. In addition to shining light on the depth of Kesha’s new songs, Rainbow also showcases Kesha’s underappreciated vocal range. In her 2010-2012 hits, such as â€Å"Blow,† Kesha’s voice barely squeezes through layers of auto-tune and touch ups. Now, Kesha’s clear vocals breathe free. In the chorus and bridge of â€Å"Finding You,† Kesha reaches high notes and lulls listeners into her romantic lyrics. â€Å"Hunt You Down† and â€Å"Spaceship† demonstrate Kesha’s sweet, southern toned voice, showing off her Nashville roots. â€Å"Baby, I love you so much,† Kesha sings with breathy vocals in â€Å"Hunt You Down,† â€Å"dont make me kill you.† Perhaps the most remarkable song on Rainbow is Kesha’s single â€Å"Praying,† a silky piano ballad laced with the cheering of a strings ensemble. In this revolutionary masterpiece, Kesha sings to the people who have hurt her, and, amazingly, chooses to wish them happiness even after everything theyve done. This song was the perfect way for Kesha to rise from under the grief that Dr. Luke caused her; instead of taking her anger out on shady social media posts, she uses her emotions and paints a harmony of healing. Kesha’s hidden talents are revealed yet again when she hits a piercing whistle note, something she would have never had the chance to display in her previous albums. This unbelievably high F6 note was so riveting that it even sparked reaction videos across her fanbase. Kesha sings in a silvery voice over the humming of a violin, â€Å"I hope your soul is changing, changing. I hope you find your peace falling on your knees, praying.† Rainbow is the flower that blooms in the midst of the battlefield, the voices that laugh even when the world spins into darkness, and the hope that stitches the horizon. Now, Kesha stomps back into the music industry with fortitude, and she sets her new life streaming into success by producing an album about loving, healing, and finding the â€Å"rainbow† in every situation.

Sexuality In Wiseblood Essays - Fertility, Sexual Acts, Sexology

Sexuality in Wiseblood That Heinous Beast: Sexuality In the novel Wiseblood, by Flannery O'Connor, one finds an unpleasant, almost antagonistic view of sexuality. The author seems to regard sex as an evil, and harps on this theme throughout the novel. Each sexual incident which occurs in the novel is tainted with grotesquem. Different levels of the darker side of sexuality are exposed, from perversion to flagrant displays of nudity. It serves to give the novel a bit of a moralistic overtone. The "Carnival Episode" illustrated Hazel's first experience with sexuality. The author depicts an incident surrounded by an aura of sinfulness. Indeed, the show's promoter claims that it is "SINsational." In his anxiousness to view the sideshow, Haze resorted to lying about his age. He was that eager to see it. When he enters the tent, Haze observes the body of an obese naked woman squirming in a casket lined with black cloth. He leaves the scene quickly. This first bout with sexuality was certainly a grotesque one, and one which, perhaps, helped fortify his resolve not to experiment with sex for years to come. Haze reacted to the incident on different levels. Before watching the "show," he was filled with curiosity. So badly he wanted to view this "EXclusive" show. After glancing at the body, he first thought that it was a skinned animal. When he realized what it was, he at once left the tent, ashamed, and perhaps frightened of the object before his eyes. Hazel's reaction was not unnatural. The sight with which he was confronted would invoke both fear and embarassment within most ten-year-olds. Not only was the body nude, but it was inside a casket as well. The author parallels this vulgar display of sexuality with death itself. But Hazel reacted to more than just the sight of the object. He at once realizes that he was not supposed to watch the naked lady, that it was sinful to do so. He feels ashamed for having gone inside the tent, and punishes himself. Here, it is evident that the author means to show that Sexuality is a sinful creature. This moral tone is reinforced by the behavior of his parents during the episode. Whilst inside the tent, Hazel hears his father remark appreciatively about the nude body: "Had one of themther built into ever' casket, be a heap ready to go sooner." After returning home, Hazel's mother realizes that her son has experienced something that he should not have, and confronts him about it. Though he does not admit what he has done, he proceeds to punish himself. It is inferred that Hazel respects his mother's attitude toward the matter. O'Connor seems to propose that Hazel must do penance for what he has done, or, on a larger scale, for witnessing vulgar displays of sexuality. Perversion reaches its height when O'Connor introduces the reader to Enoch Emery. During Enoch's various dealings with women, one witnesses vulgarity in all its forms. The events surrounding the first of these incidents is tinged with a bit of mystery. O'Connor paints the portrait of a Peeping Tom, an adolescent Enoch Emery watching a topless woman sunbathe while hidden in between abelia bushes. Strangely enough, the woman has a "long and cadaverous" face, with a "bandage-like bathing cap." Ironically, the woman also has pointed teeth, with "greenish-yellow hair." The woman is portrayed as a corpse-like figure who is surprisingly similar to Hazel's one-time mistress, Leora Watts. Sexuality comes in the form of a corpse, an allusion not to be missed. The narrator depicts Sexuality as being analogous to spiritual death. In this episode, however, one sees more than just the grotesque. Enoch Emery introduces us to the grimmer side of sexuality, a side in which a predator spies on an unknowing woman, and gains pleasure from it. The meaning behind the scene is somewhat masked by the lascivious behavior of a typical eighteen year old, but its aim is clear. Here is sexuality at its darker side: one in which women are violated unbeknownst to them. Enoch's other dealings with women are also on the perverse side. He enjoys making "suggestive remarks" towards them. The fact that they do not respond to him results from two