How Does Celebrex Cause Stomach Problem
opinion Essay
700 words
In the text, Abramson writes about a warning issued by the FDA, stating that Celebrex could cause stomach problems. This statement contradicted research results published in the Journal of the American Medical Association. Abramson describes how the JAMA article makes (false or misleading) claims that the Celebrex manufacturer couldn’t, because of FDA restrictions (Abramson, Kindle 573-575). In a review published regarding Vioxx, Abramson notes that the authors attribute a high percentage of serious complications to a small sample size. The authors maintain that Vioxx was effective and that the risks were negligible despite the data showing otherwise (Abramson, Kindle 600-602). In these cases, the researchers held prohibited relationships with the manufacturing companies of Celebrex and Vioxx.
The main issue Abramson highlights in the CLASS study is that the authors only reported the first six months. A majority of the observed complications occurred in the second six months, and the researchers pushed to exclude this data which would indicate that Celebrex could actually cause more stomach problems. The authors also combined categories that were initially supposed to be separate, in order to produce significance (Abramson, Kindle 688-702). The VIGOR study
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In an article published in 2013, researchers evaluated the effects of several dietary supplements on homocysteine concentration. According to the authors, high homocysteine levels is a risk factor for several chronic conditions. In the study, researchers compared a vitamin group to a placebo group in a population of elderly women. They concluded that the folic acid and vitamin B12 (which were given together) benefited the participants, but noted the small size of their sample at 31 patients total (Kesser, et al.,
In this essay, the author
- Analyzes how abramson writes about a warning issued by the fda, stating that celebrex could cause stomach problems, contradicting research results published in the journal of the american medical association.
- Explains that abramson highlights the main issue in the class study, which is that s only reported the first six months, and pushed to exclude this data which would indicate that celebrex could actually cause more stomach problems.
- Explains that the vigor study conducted similar methods of reporting data. while fewer stomach problems occurred, there were a greater number of cardiovascular problems in the group taking vioxx.
- Analyzes how abramson writes about a warning issued by the fda, stating that celebrex could cause stomach problems, contradicting research results published in the journal of the american medical association.
- Explains that abramson highlights the main issue in the class study, which is that s only reported the first six months, and pushed to exclude this data which would indicate that celebrex could actually cause more stomach problems.
- Explains that the vigor study conducted similar methods of reporting data. while fewer stomach problems occurred, there were a greater number of cardiovascular problems in the group taking vioxx.
- Explains that the 1994 dietary supplement health and education act (dshea) increased the sale and consumption of dietary supplements which were not being regulated for safety or efficacy.
- Opines that richard nowak proposes changes to improve regulation, drawing on practices from other countries.
- Explains that vitamin b-12 is found naturally in many foods, specifically animal products, and no adverse effects have been associated with excess b12 intake.
- Opines that the study was a double-blind, randomized control trial and the intervention group was not significantly different from the control group which supports the researchers’ initial findings.
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- Vitamin B12 Essayexplanatory essayVitamin B12 deficiency, or Cobalamin deficiency, occurs frequently among elderly people. Vitamin B12 is a nutrient that helps keep the body's nerve and blood cells healthy and helps make DNA, the genetic material, in all cells. Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak. Often times, the symptoms of this deficiency are undetectable because the signs are subtle. This creates several issues including identifying those at risk for deficiency and providing those individuals with the correct treatment. Throughout the paper I will address issues such as the causes and evaluations, treatments and procedures, and dietary impacts of vitamin B12 deficiencies using several studies related to vitamin B12 deficiency within the elderly. The purpose of this paper is to determine what the effect of lack of vitamin B12 has on the elderly and what, if any, can be a preventative for such deficiency.
In this essay, the author
- Explains that vitamin b12 deficiency is a nutrient that helps keep the body's nerve and blood cells healthy and helps make dna, the genetic material, in all cells.
- Explains that the banbury b12 study examined the association between cognitive impairment, depression, and neuropathy in older people.
- Explains that vitamin b12 deficiency in the elderly is caused by food-cobalamin malabsorption, anemia, and dietary deficiencies.
- Explains that vitamin b12 deficiency is a nutrient that helps keep the body's nerve and blood cells healthy and helps make dna, the genetic material, in all cells.
- Explains that the banbury b12 study examined the association between cognitive impairment, depression, and neuropathy in older people.
- Explains that vitamin b12 deficiency in the elderly is caused by food-cobalamin malabsorption, anemia, and dietary deficiencies.
- Explains that cobalamin deficiency is more common among patients with chronic neurological conditions, but it is unclear if these are causal relationships with the development of vitamin b12.
879 wordsRead More - Vitamin B12 Essayexplanatory essayVitamin B12 is a cofactor for methionine synthase, which regenerates methionine from homocysteine and participa...
In this essay, the author
- Explains that vitamin b12 is an essential water soluble vitamin that must be carefully regulated to prevent deficiency related complications in the nervous, gastrointestinal, and cardiovascular systems.
- Explains that vitamin b12 is a cofactor for l-methylmalonyl-coa mutase, which converts it to succinyle. it enters the citric acid cycle to produce atp.
- Explains that the schilling test is an older assay used to rule out b12 deficiency caused by malabsorption from insufficient intrinsic factor.
- Explains that vitamin b12 is an essential water soluble vitamin that must be carefully regulated to prevent deficiency related complications in the nervous, gastrointestinal, and cardiovascular systems.
- Explains that vitamin b12 is a cofactor for l-methylmalonyl-coa mutase, which converts it to succinyle. it enters the citric acid cycle to produce atp.
- Explains that the schilling test is an older assay used to rule out b12 deficiency caused by malabsorption from insufficient intrinsic factor.
- Explains that vitamin b12 is essential because of its role as a coenzyme for l-methylmalonyl-coa mutase and methionine synth
- Explains that vitamin b12 is commonly obtained in the diet through consumption of meat, nuts, eggs, milk, shellfish, and green leafy vegetables.
- Explains that pernicious anemia is caused by autoimmune response to gastric parietal cells. atrophic gastritis is a similar condition initiated by infection with the bacteria helicobacter pylori.
- Complete blood count and blood smear are the first tests to indicate vitamin b12 deficiency.
1359 wordsRead More - alzhiemerscomparative essayA study published in 2004 titled “Reduced Risk of Alzheimer Disease in Users of Antioxidant Vitamin Supplements: The Cache County Study” examined the relationship between antioxidant supplementation use and risk of Alzheimer’s. The cross-sectional and prospective study assessed 5092 elderly participants, 65 years old and older, for prevalent dementia and AD between the years of 1995 to 1997(wave I) and 1998 to 2000 (wave II). A total of 1429 from the 5092 participants were lost due to participation inability to follow up, refusal to participate and death. Buccal DNA was collected from 97% of the participants to determine genotype and a multistage screening was completed, which included the modified Mini-Mental State Examination (3MS) a screening test for dementia.
In this essay, the author
- Explains alzheimer disease is the most common form of dementia that causes problems with behavior, thought process, and memory that deteriorate over time, eventually leading to death.
- Explains that a 2004 study titled "reduced risk of alzheimer disease in users of antioxidant vitamin supplements: the cache county study" examined the relationship between antioxidant supplementation use and alzheimer's risk.
- Explains that the subjects were divided into four groups according to their use of vitamin supplementation: vitamin e users, vitamin c users and b complex vitamin multivitamin users.
- Explains alzheimer disease is the most common form of dementia that causes problems with behavior, thought process, and memory that deteriorate over time, eventually leading to death.
- Explains that a 2004 study titled "reduced risk of alzheimer disease in users of antioxidant vitamin supplements: the cache county study" examined the relationship between antioxidant supplementation use and alzheimer's risk.
- Explains that the subjects were divided into four groups according to their use of vitamin supplementation: vitamin e users, vitamin c users and b complex vitamin multivitamin users.
- Concludes that antioxidant vitamins, particularly a combination of vitamin e and c, are associated with reduced rampancy and occurrence of ad.
- Explains that a prospective study conducted from 1993 to 2000 supported the theory that antioxidant nutrients of vitamin e and c decreased the risk of developing ad.
- Explains that the 1999 review article titled "high doses of vitamin e in the treatment of disorders of the central nervous system" discussed the potency and safety of vitamin e for treating ad.
- Explains that the results were inspected with and without use of the baseline score for the mini-menta state exam. the median survival increased significantly in those who received treatment in comparison to those that received the placebo.
- Describes a multicenter randomized, double-blind placebo controlled study conducted between 1999 and 2004 to determine whether vitamin e or donepezil could delay the clinical diagnosis of alzheimer disease.
- Explains that there were no significant differences between the placebo and the vitamin e group at any time during the trial.
- Describes the study titled "a randomized trial of vitamin e supplementation and cognitive function in women" that investigated the effect of vitamin e supplements on cognitive function.
- Explains that a telephone cognitive battery test was done to assess general cognition, and it was adapted from the 3ms examination. verbal memory was tested using the east boston memory test.
- Concludes that long-term use of supplement vitamin e did not give cognitive benefits among healthy older women.
- Describes the double blind, placebo controlled, parallel group, randomized clinical trial conducted to determine whether vitamin e, memantine, or both slow the progression of ad in patients currently taking an acetylcholinesterase inhibitor.
- Explains that adcs-adl scores declined by 31.5 units less in the vitamin e group in comparison to the placebo group, suggesting a delay in clinical advancement of 19% per year.
- Explains that the study titled "cognitive function in elderly people is influenced by vitamin e status" examined the associations between vitamin e status and cognitive performance in the elderly.
- Concludes that vitamin e influences cognitive function, it is beneficial to the elderly in terms of mental and functional capacities.
- Describes a randomized clinical trial that investigated whether dietary vitamin e depletion may induce adverse effects and supplementation may result in beneficial effects relevant to the pathogenesis of alzheimer’s in healthy rats.
- Concludes that vitamin e does not appear to change the parameters involved in the progression and etiology of ad in healthy animals.
- Describes the randomized trial in the journal of the federation of american societies for experimental biology.
- Explains that vitamin e suppresses brain lipid peroxidation and significantly reduces amyloid plaque deposition in mice treated early while those treated later showed reduction in oxidative stress.
- Opines that more studies are needed to test the effect of vitamin e in the prevention and treatment of alzheimer's.
1992 wordsRead More - Corn and Pellagraexplanatory essaySelhub Jacob, and Irwin H. Rosenberg. 1984. Assessment of vitamin depletion. In Wright Richard A., Heymsfield, Steven and McManus, Clifford B., editors. Nutritional Assessment. Boston, Oxford: Blackwell Scientific Publications, Inc. p209-238.
In this essay, the author
- Explains that corn is a food eaten throughout the world. it is easy to produce and cheap, and can cause health problems due to deficiency of the b vitamin niacin.
- Explains that pellagra was the most severe nutritional deficiency disease recorded in united states history.
- Explains that pellagra is caused by a deficiency of the b vitamin niacin in the diet.
- Explains that corn is a food eaten throughout the world. it is easy to produce and cheap, and can cause health problems due to deficiency of the b vitamin niacin.
- Explains that pellagra was the most severe nutritional deficiency disease recorded in united states history.
- Explains that pellagra is caused by a deficiency of the b vitamin niacin in the diet.
- Explains that pellagra is both easy and difficult to diagnose. symptoms can vary throughout a population, but once the characteristic symmetrical lesions appear it is fairly easy.
- Explains that pellagra affects all systems of the body with the most striking involvement occurring in the skin, nervous system, and gastrointestinal tract.
- Explains the clinical manifestations of pellagra, which are divided into four stages: unwellness, digestive disturbances, severe neurological disturbance, and terminal cachectic stage.
- Explains that the first stage is characterized by indefinite symptoms such as loss of appetite, abdominal pain, flatulence and usually diarrhea.
- Explains that skin lesions are characterized by redness and symmetry that can be confused with sunburn, which it closely resembles during the first few days.
- Explains that the symptoms last from three to four months and nervous symptoms have usually already developed at the peak of this stage. the skin may remain darker in color and sometimes rough and dry for some time.
- Explains that the third stage is characterized by severe cerebrospinal disturbances and psychological symptoms, such as depression, interference with thought, slowness of ideas, and mild irritability.
- Explains that the fourth stage shows increasing weight loss, disappearance of subcutaneous fat, diminished strength and an inability to resist infection. the patient may become bedridden because of weakness.
- Explains the basic symptoms and progression of pellagra, which can vary due to the complexity of the disease.
- Explains that psychological effects can occur, such as melancholy, delusions of persecution, hallucinations, and destructive tendencies. institutionalization is necessary.
- Explains that nurses in asylums had to watch to prevent patients from drowning themselves in the bathtub. pellagra was so frequently associated with suicide that in 1915, the number of cases of pellagra in mississippi reached its highest peak.
- Explains that while many individuals ended up in institutions because of pellagra, the institutions themselves caused it in its previously healthy inhabitants due to poor diet.
- Explains the controversy over the cause of pellagra. it had been blamed on eating spoiled and unspoiled corn, the buffalo gnat, housefly, or mosquito, and attempts to treat it ranged from arsenic compounds to electric shock
- Explains that pellagra was prevalent in every state in the united states, but it was the eighth or ninth highest cause of death in many southern states during the years of 1928 and 1929.
- Explains that joseph goldberger discovered the cause of and eliminated pellagra in the united states. he was an epidemiologist and a member of the us public health service.
- Describes goldberger's study on the nutritional basis of pellagra at the rankin prison farm.
- Concludes that goldberger's experiment did induce pellagra but was limited to those who later in the study developed more characteristic pellagrous dermatosis.
- Analyzes goldberger's claims that the experimental diet lacked some essential protein component, probably an amino acid, and that it might also be vitamin deficient.
- Explains goldberger's experiments to disprove that pellagra was infectious, including inoculations of skin squames, nasal excretions, and intramuscular injections.
- Explains that corn is a staple in many cultures and not all of them are infested with pellagra.
- Explains that there were few cases of death from pellagra reported each year in the first decade of the twentieth century but by the mid 1910’s the annual number passed one thousand with the peak being about seven thousand in 1928 when it began to decline.
- Explains the two main causes for the eradication of pellagra in the united states.
- Explains that fortification of grain products was the second and most effective cause of the decline in pellagra. synthetic niacin became available to physicians in late 1938.
- Explains that mississippi is an example of the effectiveness of mandatory enrichment programs. in 1946, the pellagra morbidity rate in the state was 101 per 100,000.
- Explains that pellagra is a disease of poverty and malnutrition. joseph goldberger and others like him have eradicated the disease in the united states.
- Cites carpenter kenneth j. 1999. vitamin deficiencies in north america in the 20th century.
- Explains that park youngmee k., christopher t. sempos, curtis n. barton, john e. vanderveen, and elizabeth a. yetley. effectiveness of food fortification in the united states: the case of pellagra.
3179 wordsRead More - fdaexplanatory essayReflecting on her nearly 15 years of work for the FDA, Dr. Hertz indicated that she believes the regulatory actions of this agency are crucial now and will continue to be in the future. Protecting the American public from ineffective and unsafe drugs and facilitating the development of new drugs are roles that the FDA will continue for many years to come. Dr. Hertz is also excited about developing areas of medicine that will pose new challenges to her agency, such as personalized medicine based on differences in phenotype or genotype. Remaining flexible to new innovations while continuing to protect the safety of the public is yet another delicate line that Dr. Hertz and the rest of the FDA will have to tread in the coming years.
In this essay, the author
- Describes dr. sharon hertz's role as a supervisory medical officer with the food and drug administration in the division of anesthesia, analgesia, and addition products.
- Explains dr. hertz's work on analgesic drug development and post-marketing safety. she collaborates with academia and industry to improve study methodology.
- Opines that dr. hertz believes the regulatory actions of the fda are crucial now and will continue to be in the future.
- Describes dr. sharon hertz's role as a supervisory medical officer with the food and drug administration in the division of anesthesia, analgesia, and addition products.
- Explains dr. hertz's work on analgesic drug development and post-marketing safety. she collaborates with academia and industry to improve study methodology.
- Opines that dr. hertz believes the regulatory actions of the fda are crucial now and will continue to be in the future.
- Explains that dr. hertz was driven away from clinical practice by the demands of for profit insurance companies, which she considers the blight of healthcare and the antithesis of good public health policy.
1163 wordsRead More - Vitamin Supplements: Hype or Help?analytical essayThe worldwide obsession of vitamin supplements has exponentially risen and vitamins have entrenched themselves in the lives of individuals due to a fallacious contention promoting the ideology that vitamins are beneficial. More and more scientific research has identified the health benefits to be “less spectacular than advertised” (Lemstra). Researchers from Johns Hopkins University are cited as saying, “most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided.” Vitamin supplements fail to live up to the “hype” and are marred with risks to users.
In this essay, the author
- Explains that the worldwide obsession of vitamin supplements has exponentially risen due to a fallacious contention promoting the ideology that vitamins are beneficial.
- Explains that the relative ineffectiveness of vitamins is a generally undocumented case.
- Explains that vitamin e supplements have unknown adverse effects that negatively impact individuals' health. selenium and vitamin e cancer prevention trial found that it increased the contraction of prostate cancer by 17 percent.
- Explains that the worldwide obsession of vitamin supplements has exponentially risen due to a fallacious contention promoting the ideology that vitamins are beneficial.
- Explains that the relative ineffectiveness of vitamins is a generally undocumented case.
- Explains that vitamin e supplements have unknown adverse effects that negatively impact individuals' health. selenium and vitamin e cancer prevention trial found that it increased the contraction of prostate cancer by 17 percent.
- Argues that vitamin consumption negatively affects the public as a whole, and that neither men nor women should be tempted by the "hype" of vitamins.
- Argues that vitamin supplements are blotched with risks and infective tendencies to be duly "hyped."
539 wordsRead More - According to survey, held by U.S Department of Health and Human services, by 2007-2008 years approximately one half of U.S. population used at least one prescription drug, 10% of population used more, than five drugs at month, in addition between children one out of five used at least one or even more prescription drugs (Gu, Dillion and Burt 2010). In order that patients receive effective treatment by 1980 U.S. Food and Drug Administration approve special clinical trials1(see Appendix 1 to the definition), that determine drugs' most frequent side-effects and emphasize their effectiveness (U.S. FDA 2012).When assessing the efficiency of a new medicines, it is usual to test the medicaments in a "randomized double-blind placebo controlled trials". In these trials results obtained from experimental2 and control3 arms are compared and the difference is considered. Drug is considered effective if statistically significant difference4 ,often called effect size, between two group is detected. Other way the medicine is regarded as ineffective and treatment based on this medicine is not better than treatment via placebo (Wampold 2005). As follows placebo controlled studies are important part of pharmacological research because it emphasizes real treatment effect of developing medicaments and prevents releasing ineffective drugs for sale. The purpose of this project is to argue that placebo studies should be used in the health trials in pharmacological research because these studies determine the real treatment effect of a drug. The first section of this paper will briefly explain what "placebo" is , then clinical trials, based on this effect will be examined. Then, the importance of using placebo studies in medical research ...
In this essay, the author
- Argues that placebo studies should be used in the health trials in pharmacological research because they determine the real treatment effect of a drug.
- Explains that the term "placebo" has had a long and controversy history in medicine — it was first introduced into medical terminology in the late 18th century.
- Explains the importance of accounting for placebo effect in medical research while testing drugs. wager argues that the placebo itself could be a possible cure of such diseases.
- Argues that placebo studies should be used in the health trials in pharmacological research because they determine the real treatment effect of a drug.
- Explains that the term "placebo" has had a long and controversy history in medicine — it was first introduced into medical terminology in the late 18th century.
- Explains the importance of accounting for placebo effect in medical research while testing drugs. wager argues that the placebo itself could be a possible cure of such diseases.
- Explains that clinical trials evaluate medical knowledge about a disease, syndrome, or condition. the randomized double-blind placebo control group study's design is demonstrated in figure 1.
- Explains that the outcome from any treatment is sum of beneficial effects caused by natural course, placebo and active treatment influence. the difference between specific tx effect and placebo effect is considered as treatment effect of medicine.
- Explains the importance of placebo controlled studies in pharmacological research.
- Argues that the widespread use of placebo studies in pharmacological research is important and should be continued.
- Explains the fda's drug review process: ensuring drugs are safe and effective.
- Explains that there are several issues that need to be considered about the placebo studies, such as the ability to distinguish the active treatment from placebo.
- Cites gu, qiuping, charles f. dillon, and vicki l. bur. prescription drug use continues to in-crease.
1852 wordsRead More - The Negative Impact of OTC and Pescription Drugsopinion essayAdvil, Aleve, Tylenol, Benadryl, Sudafed, Claritin, Nyquil. The list seems to never end and they all achieve the same purpose. Forget wanting to feel better, America craves a binge drug to provide hope in the oh-so relentless cold that has been affecting them for longer than desired. Of the millions upon millions of people who daily rely on OTC and prescription drugs to suppress their cold, headache, heart burn etc, many do not understand the impact of drug consumerism on a broad scale. What is at stake? Is our need for over the counter drugs and prescriptions becoming customary instead of necessary? Should over the counter and prescription drugs be regulated more strictly? The adaptation of drugs like most staple products is a reliance that may be more intricate than previously acknowledged.
In this essay, the author
- Opines that america craves a binge drug to provide hope in the oh-so- relentless cold that has been affecting them for longer than desired.
- Argues that adaptation techniques to cure ailments have been crucial to protect the well-being and sustenance of physical and mental health.
- Explains that many americans have the luxury of preparing with a complete array of assistive products when the dreaded common cold relapses. household names such as kleenex, campbells, halls and more recently in modern culture, companies like robitussin exemplify convenience.
- Opines that america craves a binge drug to provide hope in the oh-so- relentless cold that has been affecting them for longer than desired.
- Argues that adaptation techniques to cure ailments have been crucial to protect the well-being and sustenance of physical and mental health.
- Explains that many americans have the luxury of preparing with a complete array of assistive products when the dreaded common cold relapses. household names such as kleenex, campbells, halls and more recently in modern culture, companies like robitussin exemplify convenience.
- Explains the ftc's responsibility of what products are to be used by the american public and millions of visitors to the united states.
- Explains that the most overbearing use of an otc or prescription abused drug is a dietary product reffered to as fen phen.
- Explains that prescription drug dependence is an epidemic that continues to be prevalent in modern society. actors and actresses who have abused and succumbed to drug abuse are recognized as examples of the misapplication of prescription drugs.
- Opines that the use of marijuana has gained legal status recently in several states for "medicinal purposes." the government and private businesses strive to earn a profit through rationalization.
- Opines that our obsession with the medicine industry only serves to diminish our oppurtunity to be healthy and appropriatley assess medical obligations if misuse of drugs continues.
1271 wordsRead More - The trial’s goal was not to test Vioxx’s safety, but rather to test it’s effectiveness in preventing colorectal polyps in patients with a history of colorectal adenomas. The trial was stopped prematurely once these statistics were discovered.
In this essay, the author
- Opines that the patient should be informed of the dangers of drugs but given the choice.
- Explains that kevin swearingen's two-story fall in 1988 left him with arthritis on the inside of his spinal column causing him pain, frustration, and depression.
- Opines that the fda and merck are being criticized for the lack of research on the drug.
- Opines that the patient should be informed of the dangers of drugs but given the choice.
- Explains that kevin swearingen's two-story fall in 1988 left him with arthritis on the inside of his spinal column causing him pain, frustration, and depression.
- Opines that the fda and merck are being criticized for the lack of research on the drug.
- Explains dr. bukowsky's opinion that the first attempt at relieving pain for musculoskeletal problems should be an over-the-counter drug like ibuprofen, alive, or advil.
- Pat price flatt, 55, from ontario, does not take any nsaids because her doctor said the heart risks are too high since she smokes.
2136 wordsRead More - Prescription Obesity Drugsexplanatory essayIn 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi...
In this essay, the author
- Opines that fda provides sufficient guidance on the development and registration of prescription diet medications.
- Explains that fda's grounds for rejecting the ndas of prescription diet pills in the last 10 years were based on safety/efficacy concerns.
- Explains that fda considered 'potentially alarming' safety signals from nonclinical toxicology studies in animals or in vitro studies when making their decision on an nda.
- Opines that fda provides sufficient guidance on the development and registration of prescription diet medications.
- Explains that fda's grounds for rejecting the ndas of prescription diet pills in the last 10 years were based on safety/efficacy concerns.
- Explains that fda considered 'potentially alarming' safety signals from nonclinical toxicology studies in animals or in vitro studies when making their decision on an nda.
- Opines that if a prescription diet pill were to be approved, explain how specific fda measures, restrictions, and conditions of use can be used to ensure public safety.
- Explains that there are no biomarkers approved by the fda that would act as a safety signal for patients taking prescription drugs for obesity.
- Explains that the fda approved meridia in november 1997 following a positive position by the advisory committee review held in september 1996.
- Cites abbott laboratories' advisory committee briefing document for meridia® (sibutramine hydrochloride monohydrate).
- Explains the fda's approval of lorqess (lorcaserin hydrochloride) tablets, 10 mg.
- Summarizes fda's guidance for industry. developing products for weight management. fda. (2011). predictive safety testing consortium.
1273 wordsRead More - Against Animal Experimentationopinion essay“According to the General Accounting Office, more than half of the prescription drugs approved by the Food and Drug Administration (FDA) between 1976 and 1985 caused serious side effects that later caused the drugs to be either relabeled or removed from the market. Drugs app...
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- Opines that creatures have the same rights that we do. harper's magazine, 1997.
- Opines that testing drugs on animals is untrustworthy and can cause unknown side effects. animals are biologically similar, but not identical to humans.
- Explains that animals have helped form useful medicines for humans, but they have also helped put dangerous drugs on the market.
- Opines that creatures have the same rights that we do. harper's magazine, 1997.
- Opines that testing drugs on animals is untrustworthy and can cause unknown side effects. animals are biologically similar, but not identical to humans.
- Explains that animals have helped form useful medicines for humans, but they have also helped put dangerous drugs on the market.
- Explains that animal testing fails to forecast the majority of human adverse drug reactions, which in turn causes almost 5% of all hospital admissions and occur in 10-20% of hospital in-patients
- Explains that humans are better test subjects than animals because it is impossible to re-create naturally occurring human diseases that arise from within.
- Explains that humans differ from other animals in outward appearance and intelligence, but from a biological perspective humans are classified as animals.
- Concludes that animal experimentation does not solve medical problems and doesn't help our country advance in the field of medicine.
1703 wordsRead More - The Pros And Cons Of Pharmaceutical Advertisingopinion essayPharmaceutical companies have a wide variety of scientific evidence based on their previous and most recent clinical trials on every type of drug they introduce in the advertising world. However, one of the few problems they are facing is that there is too much information being presented to the consumer during broadcast advertisements. In turn due to the overwhelming amount of information, consumers are missing key medical facts that are needed to make an informed decision regarding their health. While all ads appear to list both the positives and negatives of the medication, some advertisements may be more misleading than others.
In this essay, the author
- Explains that pharmaceutical companies have a wide variety of scientific evidence based on their previous and most recent clinical trials on every type of drug they introduce in the advertising world, but too much information is presented to the consumer during broadcast advertisements.
- States that pharmaceutical companies are required to submit all drug advertisements to the food and drug administration when they are first disseminated. federal regulations state that broadcast ads should have a fair balance of benefits and risk information.
- Explains that with the amount of advertisement revision requests, it is likely that some will fall through the cracks while the staff of the fda try to sort through them all.
- Explains that pharmaceutical companies have a wide variety of scientific evidence based on their previous and most recent clinical trials on every type of drug they introduce in the advertising world, but too much information is presented to the consumer during broadcast advertisements.
- States that pharmaceutical companies are required to submit all drug advertisements to the food and drug administration when they are first disseminated. federal regulations state that broadcast ads should have a fair balance of benefits and risk information.
- Explains that with the amount of advertisement revision requests, it is likely that some will fall through the cracks while the staff of the fda try to sort through them all.
- Explains that the guidelines for television ads differ slightly from those of print ads, which are usually found in doctor offices, magazines or medical journals.
- Argues that direct-to-consumer advertising has had a resounding effect on not only the consumer but the physicians.
- Opines that physicians are giving into their patients’ medication demands and it is becoming an issue with over medication people when they could achieve the same results with a simple lifestyle change of diet and exercise. broadcast ads are lacking on the informative side.
- Explains that direct-to-consumer advertising led to an increase in sales of certain medications, and that it lacks consumer friendly language.
- Explains that pharmaceutical industries have spent almost $5 billion a year in medicinal advertising. new zealand allows direct-to-consumer advertising for this degree.
- Opines that direct-to-consumer pharmaceutical advertisements exacerbate unhappiness about normal experiences and heightened expectations of drug benefits.
- Opines that advertising has become a double edged sword for the pharmaceutical industry. rising increases in medications and health care make it harder for consumers to keep up with the health standards of their physicians.
- Argues that direct-to-consumer advertising can do more harm than good. pharmaceutical companies and physicians are beginning to pave the way of over medicating the population. not all medical testing can differentiate one illness from another.
1356 wordsRead More - Pros and Cons of Genetic Testinganalytical essayJanssens, Cecile. "How FDA and 23andMe Dance Around Evidence That Is Not There." The Huffington Post. TheHuffingtonPost.com, 27 Jan. 2014. Web. 22 Mar. 2014.
In this essay, the author
- Explains that people are learning a great deal in the rapidly growing and developing fields of science and technology. genetic testing promotes prevention efforts for genetically susceptible people and provides new strategies for disease management.
- Opines that genetic testing results may shorten your life or have no cure, disrupting an individual physically and emotionally; healthy people who carry the burden of having a life-threatening disease lack social support and coping skills.
- Explains that a year before the supreme court's roe v. wade decision legalized abortion on demand nationwide, virtually all children with trisomy 21, or down syndrome, were born.
- Explains that people are learning a great deal in the rapidly growing and developing fields of science and technology. genetic testing promotes prevention efforts for genetically susceptible people and provides new strategies for disease management.
- Opines that genetic testing results may shorten your life or have no cure, disrupting an individual physically and emotionally; healthy people who carry the burden of having a life-threatening disease lack social support and coping skills.
- Explains that a year before the supreme court's roe v. wade decision legalized abortion on demand nationwide, virtually all children with trisomy 21, or down syndrome, were born.
- Argues that aborting a baby on grounds of disability is the ultimate form of discrimination.
- Argues that the food and drug administration has taken precautions to prevent scientific information from being released to the public.
- Quotes murphy, samantha, and techmedia network's livescience article, "genetic tests debate: is too much info bad for your health?"
- Describes the innocence project's faqs. how many people have been exonerated through dna testing?
- Opines that genetic testing will improve the outcome of gene therapy.
- Describes the various aspects of genetic testing, such as whether it's good, bad, or benign.
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