Friday, September 6, 2019
Women Prisons Before the 1800 Essay Example for Free
Women Prisons Before the 1800 Essay â€Å"Women were punished as men were, with the exception that pregnant women were often spared punishment until after they had given birth. Women were generally mixed with male prisoners and supervised by male jailers, which made the women doubly subject to abuse and exploitation.†(Foster, 2006) Women who violated the law, then, also violated their subservient position and were seen as morally suspect as well as criminal. Prior to the development of prisons in the seventeenth and eighteenth centuries, punishment for women and men took a variety of forms: Serious offenders were put to death by hanging or burning, or banished from their community or sold as slaves How have they changed? The Indiana State Reformatory was established in 1873 as the first separate prison for women in America. (Foster, 2006) The women in prisons are still treated the same except they have separate prisons and more rights to help them when they are abused. They still do have coed prisons in Illinois but they are minimum security prisons. What are the three basic arguments established in the 1800s that supported the separation of juvenile prisoners from adult prisoners? 1. The penitentiary regimen was too hard on tender youth. 2. Juveniles would learn bad habits from older criminals and be embittered by The experience of confinement. 3. Adolescents could be reformed if they were diverted early enough into institutions Designed specifically for people their age. What would happen if there were no distinction between prisons for juveniles and adults? It would be like sending flocks of young sheep to live with older wolves. The juveniles would be exploited and exposed to a great deal immoral and illegal things. What was the purpose of prison labor? In the 1800s, prisons recouped their expenses by leasing convicts to private companies; in 1885, fully three-quarters of prisoners were involved in some form of labor, mostly for private companies or individuals (du Pont, Some Benefits of Prisoner Labor). This had little to do with attempts at rehabilitation. Prisoners were forced to work without pay, often in dangerous conditions; convict miners were killed in cave-ins in the 1800s (Leonhardt A1). In 1887, Congress for the first time attempted to outlaw the leasing of convict labor to private parties (Ingley 28+), but there was backlash at the state level: refusal to house federal prisoners. What finally drove legislation restricting prison labor were the Depression and the increasing fear that private jobs would be lost to cheaper convict labor. The 1935 Hawes-Cooper Act, along with the Ashurst-Sumner Act of 1940, outlawed interstate trade in convict-made goods, making it a felony and a federal crime to traffic in them (OMeara 14; du Pont, Some Benefits of Prisoner Labor). Subsection (b) of the Ashurst-Sumner Act does exempt goods made in State prisons for use by any prison in any other state, or federal prison-made goods for use by any other federal prison (Ingley 28+). Congress banned prison labor use on federal contracts exceeding $10,000 the same year (du Pont, Some Benefits); the Walsh-Healey Public Contracts Act placed limits on the purchase of prison-made goods by the federal government (Ingley 28+). Corrections: The Fundamentals, by Burk Foster. Published by Prentice-Hall. Copyright  © 2006 by Pearson Education, Inc. Du Pont, Pete. Some Benefits of Prisoner Labor. The San Diego Union-Tribune 30 Nov. 1995: pg.? Leonhard, David. As Prison Labor Grows, So Does the Debate. The New York Times 19 Mar. 2000, final ed.: A1. Ingley, Gwen Smith. Inmate Labor: Yesterday, Today and Tomorrow. Corrections Today v. 58 Feb. 1996: 28+.
Thursday, September 5, 2019
Solid Waste Management And Urban Development Environmental Sciences Essay
Solid Waste Management And Urban Development Environmental Sciences Essay Solid waste management is an integral part of the urban environment and planning of infrastructure to ensure a safe and healthy human environment while considering the sustainable economic growth. Waste disposal has posed a problem in most countries and it is affecting the economy and development of the country. How? In an unhealthy environment, the citizen will fall ill, will not attract investors, knowledge and ideas will not be explored and the cost of living will be high but in a healthy environment, investors will always want to be there, healthy manpower to explore, great place to visit (tourism), economy growth and development. The aspect of recycling as referred means of waste disposal than has not been fully adopted by most countries because they have not recognized the positive impact recycling has on the environment. The focus of this research is to look at recycling municipal solid waste as a means to achieve sustainable development and economic growth. This study will be based on an investigative method, surveys, questionnaire, secondary data, interviews and observations. This is to bring out the benefits of recycling waste than disposing waste to landfill. INTRODUCTION BACKGROUND OF STUDY Sustainable development requires an environmental sound, cost effective and socially acceptable management of solid waste product. Waste is the consensus that has to be reduced or avoided and non- avoided waste has to be reuse or recycled as far as possible under well-balanced economic and ecological conditions (NORDTEST 2004). Recycling contributes to a healthy, united community but has not fully been recognized as a way of reducing waste product and creating development. Waste is seen by the society as material perceived to have little or no value. The waste generated are in large quantities, facing disposal problem in such that it has become a nuisance problem. The improper solid waste disposal is as a result of dumping waste along the road side, dumps sites and illegal landfill sites, has led to pollution of the environment and prevention of development in a country forgetting that waste can be recycled. It is seen that a large number of people do not recycle their waste; they pack up all types of waste into one bin. Most of this waste when disposed of separately can be recycled (Bzowy 2007). This in-separation of waste could be as a result of unawareness by the people on the need to recycle, the need to identify the recyclable waste and separate it, and the appropriate bin to dispose it. The amount of waste generated from the different source could be a good source of business after separation and the collection. The possibility of exploring recycling solid waste product has not be taken into full account in the form of sustainable development and revenue generation. In some countries where solid waste disposal is mainly to dump site and landfill, they constitute environmental impact than recycling. In dump site and landfill, the environmental impact is the emission of methane gas contributing to global warming, reduction of available land for development, contamination of land and ground water, breeding ground for rats, flies and other vermin which can be a potential threat to transfer of disease to human and environment. To tackle this issue, legislation was introduced in local and national basis of different countries with the aim of increasing recycling and re-use of solid waste and products for sustainable development. In EU, landfill directives aim is to reduce landfill waste disposal by imposing landfill tax to reduce the amount of biodegradable waste going to landfill to 75% because the decay produce methane, a strong greenhouse gas that contributes to climate change and land is becoming limited making landfills difficult to establish (POST 2005). Most European countries are diverting from landfill waste disposal to recycling. Recycling is seen as an economic development tool as well as environmental tool; it offers direct opportunities for communities. When wastes are recycled, the cost of disposal is reduced because the recycled wastes are sold to manufacturers as raw materials generating revenue. Recycling creates door that attract investors to the country through the remanufacture of the waste, creating jobs and tax revenue. A communitys duty to a cleaner environment often reflects its commitment to a higher standard of living and attracts companies that reprocess recyclables and suppliers who reuse these materials in their product (US EPA 2009). Recycling is a good measure in controlling waste generation, although it is third in the hierarchy of waste management but it is well adopting by any country to control waste generation to build up. Recycling is a very profitable business: which is actually declared: one mans garbage is another mans gold. Recycling of waste whatever its form is a very sound approach to mounting problem therefore encouraging development. This is what I am researching, on the usefulness of waste in the community (country) especially focusing on recycling as a means of sustainable development and revenue generation. STATEMENT OF THE PROBLEM This study was concern mainly on the development and revenue generation through recycling waste product. Why should waste be recycled? How can sustainable development be achieved through recycling solid waste? Can revenue be generated from recycled waste? How can encouraging the citizens towards recycling waste be achieved and who is responsible? AIMS AND OBJECTIVES The study aims at The justification that recycling municipal solid waste is a means of development and revenue generation. Identifying the recyclable materials, Creating awareness to people on separation of waste and making it know that; Recycling waste can leads to development and revenue generation (employment). To ensure that about 80% of waste are recycled. THEORITICAL FRAMEWORK Recycling solid waste is aimed at discouraging the disposal of waste to landfill, dump site and promote a sustainable environment that will attract investors, create opportunities, create employment, generate income and help in the reduction of greenhouse gas effect to the environment. It is also designed to educate the people on the need for sustainable development. The baseline data collected from the result will serve as a guide of other researches in their quest for additional knowledge. It can also be for those interested in the field of total waste reduction or zero waste emission. SCOPE AND DELIMITATION OF STUDY This study is delimited is to recycling of solid waste as a means to sustainable development and revenue generation in different parts of the world but using Coventry as my study area due to availability of quick data. ADVANTAGES OF RECYCLING WASTE Economic Advantages- Reduces cost for waste disposal and raw material purchase. It saves cost on energy. It increases revenue through tax from landfill. It create employment, example collection, sorting Environmental Advantages- Reduces the amount of waste produces. Reduces the amount of waste disposed at landfill It increases storage of carbon in trees. It minimises the risk of present and future environmental pollution and harm human health. It makes good use of waste produced. DISADVANTAGES OF RECYCLING WASTE Economic Disadvantages- It cost more when prices are low for a particular material. Initial capital- Purchasing the equipment. Environmental Disadvantages- Transportation of waste example energy use, noise and emission from vehicle. Disposal of waste, example noise pollution, emissions. DEFINITION OF TERMS WASTE The EC Waste Framework Directive defines waste as any substance or object which the holder discards or intends to discard (Williams 2005). RECYCLING Recycling is the process of collecting used materials which is usually considered as waste and reprocessing it. In this process, the waste are sorted and processed to be used as raw materials for the production of new product (Ghosh 2008). LITERATURE REVIEW RECYCLING SOLID WASTE AS A MEANS TO SUSTAINABLE DEVELOPMENT AND REVENUE GENERATION Waste is seen as inefficiency and less inefficiency the more waste. Inefficiency combined with the continuous growth of waste means depleting earths resources and the resources are limited. In order to preserve it for the next generation, they deserve to be used efficiently. Production, consumption and waste disposal patterns in the UK are currently not suitable for sustainable living. The wastes are currently disposed to landfill which produce a large proportion of greenhouse gas and rely on the input of non-renewable resource that could be reused, recycled or recovered for energy. The goal is to create a sustainable environment from waste through recycling and live within our environment without compromising our quality of life (DEFRA 2009). Reduce Re-use Recycle Energy Recovery (Incineration) LandfillIn the hierarchy of waste, recycling is the third for the control of waste. This recycling process involves the creation of employment that leads to development and sustainable income. Figure 1 The hierarchy of waste management. Source: Williams, 2005. The European Waste Framework Directive (1975) has at its centre the hierarchy of waste management and the basis of its strategy, is to encourage movement up the hierarchy and thereby increase the levels of waste reduction, re-use and recycling (Williams 2005). It was clear that there has to be an accurate definition and classification of waste to know the actual type of waste that will be recycled and useful. Recycling is widely assumed to be environmentally beneficial, although collecting, sorting and processing materials does give rise to environmental impacts and energy use (POST 2005). It can take place within the manufacturing industry or can take place at the post- consumer stage, example paper can be collected separately from the waste and then re-enter the paper processing machine (Williams 2005). In 1987 the Commission on Environment and Development issued a report that defined sustainable development as those forms of development that allows people to meet the needs of the present without compromising the ability to meet the need of the future generations (Weinberg, Pellow and Schnaiberg 2000:4). Recycling waste product brings about sustainable development and revenue by creating route for collected commodities to be sold in the marketplace. A comprehensive and efficient recycling programs offer more opportunities for the community to benefit financially, while improving the aesthetic appeal of their neighbourhoods through boosting tax revenue- that is used for community projects such as public parks, alternative transportation and educational grants (US EPA 2009). Studies has confirmed that in United State, recycling has emerged as a consensual policy with its promise to reduce landfilled waste, create jobs, produce revenue for cities and profit for business. Example in Florida, the Recycling Economic information Study completed in 2000 shows that about $62 million in state tax revenue was as a result of the direct effect of the recycling and reuse industry (US EPA 2009). It has constituted a model of sustainable community development because it is one of the very few ideas proposed by advocates that embrace all of the three Es- Economy, Equity and Environment (Weinberg, Pellow and Schnaiberg 2000:7). As EPAs Recycling Economic Information Study says recycling industries not only offer higher paying jobs, than national average, but they also prevent communities from disposing beneficial materials into landfills (US EPA 2009). In New York, recycling programme was established involving the trade associations from various packaging industries to promote recycling in all communities. This removed more pressure on local landfills; the market for recyclable increased, remanufacturers started using recyclable and found that it was cheaper than virgin materials. The recycling technology company started developing, employing many people and the industrys revenue increased (Weinberg, Pellow and Schnaiberg 2000:21). Recycling is the need of the hour as many environmental issues is been reeled out. The destruction of the rain forest for the production of paper, has led to the extinction of many species. The rainforest plays an important role in maintaining the ecosystem. This means that we are all interdependent and this necessitates recycling at every step. The plastic industry and paper industry are striving well through recycling and the end product is used to manufacture new product especially plastic which are not biodegradable can be reprocessed into tables and chairs, tooth brush, carpet (Gaikwad 2009). According to a lecture delivered as part of module M51GED, for every one ton of paper recycled, it saves 17 trees, 3 cubic yard of landfill space, 7,000 gallons of water, 4200kWh (enough to heat a home for half of a year), 390 gallons of oil and prevents 30kg of air pollutants (Bateman 2009). Studies have shown that recycling has created job in different areas where people were not employed and has increase their income generation. In 2002, Washington County started recycling with one trailer and one employee but today, the recycling company has growth. The Washington County had collaborated with neighbouring counties leading to the involvement of six counties in recycling and providing opportunities to the rural areas that otherwise would not receive services (US EPA 2009). It has also brings community to together. This was done after the Hurricane Katrina devastation; Harrison County in Mississippi started a road to recovery and identified recycling as a means for rebirth. The EPA aided in setting up of a recycling centre for white goods and other materials to could be salvaged from the disaster. Harrison took further step in improving the county by restoring curb-side recycling and implementing household hazardous waste drive each year to which has now improve the coun ty (US EPA 2009). It is seen that recycling waste is developing some countries, example the solid waste and recycling firm industry in United State is making inroad into Asian nations because these countries are opening their growing consumer market (Weinberg, Pellow and Schnaiberg 2000). The European Community Environmental Action Programmes also call for significant changes in current patterns of development, production, consumption and behaviour in order to achieve sustainable development (Williams 2005). In 2001, the EU made a sixth action programme on sustainable development which waste prevention and management was the key issue and it emphasized the need to achieve a situation where the most of the waste generated are either reintroduced into the economic cycle through recycling or are returned to the environment in a useful (composting) or harmless form (Morrissey and Philips 2007). Recycling does not only affect our environment positively, it has re-created the lost resources, increase wealth, population and technology of various lifestyles. It has also led to unmanageable amount of waste. Recycling has helped in restoring the habitat and forest (Gaikwad 2009). It embodies an ethic, a way of relating to the world, worthy of support. Yet city after city have embraced it and it can be justified that it is a good investment (Seldman and Lease 2002). This can be achieve through The legislation on waste management in which recycling is a major key. The awareness of people towards recycling municipal solid waste especially the households. The provision of the different waste bins at the appropriate place. Organization of seminars, programme, publications, leaflets on waste management and recycling. ENVIRONMENTAL POLICY ON RECYCLING SOLID WASTE The European legislation has a strong influence on the national waste policies. Each policy is in line with each countrys legislation on solid waste. Waste Framework Directives- This established the general rule of waste management that was introduced in 1975 (75/442/EEC). This directive was amended in 1991 and 1996 subsequently. The framework directive has central principles: The waste management hierarchy which involves prevention, re-use, recycling and recuperation of energy and materials get priority. Using the Best Available Technology (BAT) for waste disposal using technological, environmental and economic selection criteria. Waste must be treated at the place of production or collection. Applying the polluter Pays Principle to any polluters through waste disposed (Dubois, Gonzalez and Knadel 2004). The European Commission Communication of 12 December 2005 setup Taking sustainable use of resources forward: A Thematic Strategy on the prevention and recycling of waste. To reduce the negative impact of waste on the environment through its life-span from production to disposal through recycling. It made that every item of waste is not only seen as a source of pollution reduction but as a potential resource to be exploited. To promote recycling sector in order to reintroduce waste into the economic cycle in the form of quality products. The strategy also provides for other measures, such as exchange of information on national disposal taxes as well as, measures which would supplement the market should there be inadequate increasing recycling levels (Europa 2007). UNITED KINGDOM LEGISLATION ON WASTE The UK legislation implemented the European Waste Framework Directive through the national legislation: Environmental Protection Act 1990. The Control of Pollution (Amendment) Act 1989 The Waste Management Licensing Regulations 1994 (as amended) The Controlled Waste (Registration of Carriers and Seizure of Vehicles) Regulations 1991. The legislation requires that anyone who treats, keeps, deposits or disposes of waste needs a waste management licence (unless exempt or excluded) which includes conditions relating to operation at the site which is issued by the Environmental Agency and monitors the activities to ensure compliance for the safety of the environment (Net 2004). The legislation set up national waste strategies with a target aim of raising the national recycling rate up to 25% by 2005/06 using the baseline 1998/99 and diverting waste from landfill as required from Landfill Directives and include recycling, recovery and composting of different types of waste especially biodegradable waste for sustainable waste management (Net 2004). The Power of Recycling Waste under the Environmental Protection Act 1990: This deals on the effects for conferring on waste disposal and waste collection authorities power for the purpose of recycling waste. That the waste disposal and collection authorities are to buy or acquire waste with a view of recycling it. To make waste disposal contractors recycle waste (EPA 1990). The Packaging and Packaging Waste Directive 94/62/EC obliges UK to meet the target for recovery and recycling for packaging waste. It was introduced by the UK Government in 1997 to meet 2001 in which most targets agreed by the European Union to be met by 31 December 2008 with overall target was 60% for recovery and 55%-80% for recycling. In November 2005, a new target was set for 2010 with minimum amount of recovery to be achieved through recycling of 92% (Net 2004). The Household Waste Recycling Act was introduced in UK in 2003- that all English authorities to provide kerbside collections for the minimum of two recyclable materials by 2010 (POST 2005). WASTE GENERATION Waste is produce in the course of acquisition of raw materials, refining and manufacturing and product used by consumers. Wastes are produced in large quantities from the different sources that use this manufactured product. Our everyday activities can produce large variety of waste from different sources; it could be solid or liquid waste and this serve as a useful tool for sustainable development if recycled especially municipal waste. In 1990s, it was estimated that each person in the world generated 200kg of solid waste per year and this was forecasted to increase with the growth in population (Manyanhaire 2009:2). From the estimate of Europe waste, 3.5 tonnes is generated per person and this is mainly made up of waste coming from household, commercial activities (Shops, restaurants, hospitals), industry (pharmaceutical companies, clothes manufacturer), agriculture (slurry), construction and demolition projects and mining and quarrying activities and from the generation of energy. With the production of such large quantities of waste produced, it is important to manage it in a way not to cause any harm to either human health or the environment (EIONET 2009). Wastes are produced from different sources and they are classified according to their sources and production. They are- Municipal Waste These wastes are from residential such as household, commercial such as small business, office buildings and institutional such as schools, hospital, government buildings sources that are discarded (Masters 1990). Municipal waste comprises of residue waste, bulky waste, sweeping, litter collections, secondary materials from separate collection and household hazardous waste. The waste is made up of paper, glass, textiles, cardboard, organic waste (food and garden waste) and wood (EIONET 2009). Household waste is about 82% of the total municipal solid waste (Eurostat 2003). Agricultural Waste This consists of organic waste such as manure from livestock, slurry, soiled water and silage effluent, crop residue, plastic, scrap machinery, fencing, pesticides, waste oil and veterinary medicines (EIONET 2009). The waste generators are from crops, orchard, farm, feedlot (Daniel and Thomas 1999). Some are use as animal feed or for compositing (Williams 2005). Industrial Waste This consists of different manufacturing industries- Light and heavy manufacturing, fabrication, power and chemical plant. This waste is made up of food, cardboard, beverages and tobacco, hazardous waste (chemical), metals, wood and paper. It is similar to that of municipal waste (US EPA 2009). Construction and Demolition Waste This involves waste from residue during construction and waste when demolition takes place. The waste generators are construction of new buildings, renovation of site and total or partial demolition. The wastes consist of wood, steel, dirt (Daniel and Thomas 1999). Mining and Quarry Waste This waste is produced during extraction and processing materials such as coal, slate and metalliferous materials. Wastes are also found in rocks in-bedded with mineral resources and residue leftovers. (Wasteonline 2002). METHODOLOGY The study will make use of an investigative method as its aim to find out the rate of recycling and what material is recycled more. Data will be collected at some recycling centres. The research will include surveys from the process of collecting solid waste and recycling waste, the concern, belief and behaviour of people towards recycling waste. To answer the research questions, Data will be gathered from areas where waste recycling studied area of this research (which includes areas where waste recycling and non-recycling are been carried out). Participant observation will be carried out. Questionnaire will be distributed to the residents to know the rate of waste recycling and how actively involved they are in the exercise. Interviews will also be conducted (face to face). Secondary data will be used for this research and it will be on- Documentary sources such as journals, newspapers, organisation records, books, images. Survey Sources such as census, government surveys, official statistics and document. Multiple sources that are combined into one dataset. Data generated for this study will be compared with data from pervious study. Appropriate tables, charts and figures will be used in effective representation of analysis of all data along with narrative interviews data obtained. The data collected will be converted to numerical data for analysis and discussion. RESEARCH TIMETABLE Activity March April May June July August Confirm Proposal XXXXXXXX Research Activities XXXXXX XXXXXX Analyse findings and informal write up XXXX XXXXXXX Write Up XXX XXXXXXXX XXXX Complete Write up XXXXXXXX Draft and Update XXXXXXXX Deadline and submission XXXXXXXX
Wednesday, September 4, 2019
Changing Marketing Strategies of Pharmaceutical Companies
Changing Marketing Strategies of Pharmaceutical Companies Abstract Pharmaceutical companies spend large sums of money in the time-consuming research and development of new drugs and the new classes of drugs. Each company marketing in the US seeks the possible payoff of staggering high profits which is possible on their patented medicines. Because of the lack of price regulation in the marketing environment in the United States, the United States has become a premium sales market targeted by all pharmaceutical companies. This explains the continued willingness of each pharmaceutical company to persist through the entire long process of idea, creation, development, testing, approval, marketing and distribution despite the high possibility of product failure. The pharmaceutical companies have had to additionally contend with more US federal FDA rules, regulation and oversight in the United States for the entire process before receiving clearance to start marketing their drug product. Other influences like HMOs and Social Security cap limits affect prof itability structure. Over the last fifty years newer marketing strategies by pharmaceutical companies on prescription drugs include a directive appeal to the end consumer to increase the odds of making corporate profits and a marketing focus on social and internet interaction. Introduction Pharmaceutical companies produce specialized medical drug material designed to fill a need. These pharmaceutical companies are usually multinational operations located in key countries around the globe. Many have grown to become complete facilities that attempt to do the entire spectrum of research, develop, test and finally market the subject drug in order to reap the whole benefits possible from the entire cycle (Kaitin, 2010). The pharmaceutical industry has shown over time that they have the capability to increase consumer perceived value with their unique drug products using their own successful plans for timely marketing. But because of these old and new factors causing cumulative hurtles, a new trend in marketing in the pharmaceutical industry is now to additionally market direct to the customer, for example: TV advertising spots showing a new superior drug product which has special features making it directly appealing to a consumer. Changes in basic marketing structure tacti cs will be evaluated for the key levels of pressure from these internal and external factors as these pharmaceutical companies seek to address continuing ongoing product failure rates, increasing US regulation and the ever present potential competition from others inside their own industry. This trend has been a natural development over the last hundred years or so. This is reasonable because the same research that produces one drug may produce an entire class of drugs for market. Confidentiality, control, patents and oversight give these pharmaceutical companies the oversight. It also allows each pharmaceutical company to keep maximum control of all their connected environments. And by controlling these the final marketing each company achieve continues the cycle of giving the most control over the drug for the marketing campaign. The drug industry often competes worldwide and on different economic levels but in some specific territorial markets like the United States, pricing structures are not preset by the government and therefore the free market sets its own competitive standards for pricing giving the possibility and most often the probability of higher drug prices with the resultant bigger profit level opportunities. However these are offset by rigorous structural standard guidelines set by the FDA that must be complied with for any drug sold or marketed to the US public. In the past, drug companies in United States, marketed to doctors, hospitals, nursing homes and sometimes middleman companies as transitional handlers of the newest product. Marketing drugs in the United states has now changed as developers are now targeting consumers directly through television spots, online advertising and in print ads. The direct appeal is to make the end point consumer aware of the name of the drug and its benefits. The object is to have the consumer become familiar with the trade name, ask for the drug directly from their doctor thus boosting the initial sales of the new product and creating a ready market. Industry History Marchetti Schellens (2007) outline the structures of development showing it to be complex and expensive. Not only does the potential class or specific drug have to be discovered or created, it has to show promise for certain illness or disease, then pharmaceutical research can proceed through certain phases. Pharmaceutical companies have a history of costly product failures. Generally theres three clinical phrases and all this can take upwards of 15 years to complete. Additionally the FDA has trended over the last decade to creating higher pressures against drug companies by not approving as many new drugs for marketing. The probability odds are that any specific drug in early clinical phase has only 8% chance or less of ever becoming public (Food and Drug Administration, 2006) (Kummar, 2007). In the United States the U.S. Food and Drug Administration (FDA) has sought to control the drugs available to Americans because of the number of tragedies that have resulted in birth defects o r deaths. The most highly publicized incident was in the mid-1960s and the drug was called thalidomide which for pregnant women often resulted in severe birth defects. As an end result of public outrage creating governmental pressures, the pharmaceutical companies are overseen at all levels and must now successful clinical trials. Lamb(1998) writes that testing protocols have been standardized and once clinical trials are completed there is a analysis period with the end result being an application to the FDA called an NDA ( new drug application) which contains all the technical information. Over the last forty years (1970s -2010) and now in 2011 differential forces are in opposition to the ends of pharmaceutical companies. Environmental and safety issues, new technologies, mergers and the rise of managed care and health maintenance organizations (HMOs) have all effectively changed the environment thats pharmaceutical companies operate in. additionally in 1997 the FDA changed regulations relating to the presentation of risk level. This action in the United States opened the door for pharmaceutical companies to directly market to the public .This freedom for the pharmaceutical companies is offset by the FDA still having oversight surveillance of the specific phases and clinical approval. The FDA must approve the drug. After the drug is marketed there is oversight for continued compliance by the pharmaceutical companies to ensure a low-level of side effects during marketing. Post approval by the FDA comes solely after this period (Silverman, 2011). Pharmaceutical company spending on marketing exceeds that spent on research.[3][22] In 2004 in Canada $1.7 billion a year was spent marketing drugs to physicians and in the United States $21 billion were spent in 2002.[4] In 2005 money spent on pharmaceutical marketing in the US was estimated at $29.9 billion with one estimate as high as $57 billion.[3] When the US number are broken down 56% was free samples, 25% was detailing of physicians, 12.5% was direct to consumer advertising, 4% on hospital detailing, and 2% on journal ads.[4] In the United States approximately $20 billion could be saved if generics were used instead of equivalent brand name products.[3] Although pharmaceutical companies have made large investments in marketing their products, overall promotional spending has been decreasing over the last few years, and declined by 10 percent from 2009 to 2010. Pharmaceutical companies are cutting back mostly in detailing and sampling, while spending in mailings and print advertising grew since last year.[23] Historical Marketing Pharmaceutical companies have employed various methods of marketing their products and this idea can be understood by the phrase â€Å"How would you like to be in an industry where your buyers are uninformed about your product and almost 100 per cent insensitive to its price?†(The Business Edge Consortium, 2010). For many decades this was true. Around the mid 80s this started to change â€Å"The result of these industry conditions was impressive profit growth through the middle of the 1980s. With significant barriers to entry, docile suppliers, powerless buyers, almost no threat of substitutes, and little rivalry, the pharmaceutical industry in the 1980s was just about as perfect an industry as one could imagine. Given its attractiveness, the industry attracted the attention of genetic and molecular biology scientists and the venture capital community, who saw its appeal and thought their revolutionary approaches to drug therapy could attract enough money to overcome the for midable entry barriers the industry enjoyed. Thus, as scientific advances in biotechnology took hold, numerous entrepreneurial companies like Genentech and Amgen were founded to commercialize new scientific breakthroughs. Genentech, the first biotech firm having commercial success, developed a protein that broke up blood clots. Amgens famous molecular biology used recombinant DNA to produce erythropoietin, a hormone that increases the supply of red blood cells in anaemic patients under treatment for cancer and other diseases. By 2000, erythropoietin was generating $2 billion in sales and another $3 billion in licensing revenue for Amgen. Both of these new entrants fared very well in this attractive industry:Genentech went public in 1980, and by 2001 its shares had appreciated 2700 per cent since its IPO. Amgen shares, first offered in 1983, soared more than 16,000 per cent. Starting in the mid-1980s, the barriers to enter the pharmaceutical industry began to show cracks. New legislation made it easier for generic drug companies to enter the market. In the USA, the 1984 Waxman-Hatch Act, which changed the rules for generic drug manufacturers, reduced the barriers to generic entry. Instead of having to prove the generic drugs safety and efficacy, the act required companies only to prove their formulas were equivalent to that of the brandname drug. The subsequent growth in generic drugs was profound. By 1996, generic drugs accounted for more than 40 per cent of pharmaceutical prescriptions. Aside from the influx of generics, the pharmaceutical companies also saw a wave of biotechnology competitors enter their industry Genentech, Amgen and many others suggesting that economies of scale meant less than they used to, and that barriers to entry, while still high in absolute terms, were dropping, thanks in part to the availability of venture capital. Further, the biotech companies new science-focused research model, known as rational drug design, stood the traditional approach to drug discovery on its head. These drug companies worked backwards from known disease biochemistry to identify or design chemical ‘keys to fit the biochemical ‘locks of that disease.†Traditionally they employed very effective strategies that includes educational sponsorship to cover the costs of continuing instruction for top medical personnel, sponsorship of articles in well-respected journal publications, providing free drugs samples to doctors and promotional gifts that include a corporate logo or specifics about a drug the idea behind the promotional marketing is to simply connect the new drug with an old medical symptom and encourage the writers of the prescription to fulfill the marketing cycle. Promantally pharmaceutical samples are still given out to doctors as a promotion and marketing tactic and it works (Alexander, Zhang Basu, 2008). A few generations ago these forms of marketing worked well for the pharmaceutical companies. However circumstances have changed. The FDA seeks to discourage the intimate connection between pharmaceutical companies and their pharmaceutical representatives is the connection to the doctors prescribing medicines, these days d octors see more patients and fewer pharmacy drug representatives, additionally there is a continuing trend by hospitals, doctors and pharmacies towards being conservative in their recommendations and prescriptions because of lawsuits of all kinds (Pharmaceutical Industry History, 2007). Medical drug malpractice suits in the US are rising. Fiscus (2008) writes that â€Å" In the United States, the growing use of DTC advertising has raised challenges to one of the strongest defenses available to drug manufacturers against failure to warn allegations in product liability suits for prescription drugs and medical devices: the learned intermediary doctrine. Under this doctrine, a manufacturer fulfills its duty to warn by adequately informing a learned intermediary, typically a physician.†Current Marketing .In 2010 the global pharmaceutical market is worth over 825 million with a large percentage of this comes from newer and mature drug products and there are over 100,000 health-related websites (The Business Edge Consortium, 2010). The statistics show that marketing by pharmaceutical companies is changing because of external pressures. There has been a dramatic rise in U.S. physicians routinely using d the web to check or research information making the relevance of digital promotion all the more important Pharmaceutical companies have risen to the changing challenge of Internet marketing and now promote and advertise doctor friendly physician and customer service online portals like PubMed, the U.S. National Library of Medicine, National, and Physicians Interactive (Kaitin, 2010). Pharmaceutical marketers are relying more on connecting digital medical information to their target audience through focused marketing, interactive social media campaigns, and cell and mobile linked advertising all targeted to connect to the 145 million + U.S. adults who go online for health answers . The old saying â€Å" time is money†is accurate in the case of pharmaceutical companies as it takes upwards of 15 years to develop a potential drug which only has a 8% probability of getting out of trials and going to market. Therefore it is a necessity to carefully control costs and expenses where possible. One major area of expense has been having marketing representatives which were costing out as high as15 to 20% of a pharmaceutical companies annual drug product revenues. As pharmaceutical company overall expenses and costs have additionally escalated over the last few generations there is a need to reduce expenses down where possible. So the switch from costly pharmaceutical representatives to cheaper graphic marketing is easily understood. Finkelstein (1997) wrote that Competitive and technological changes in the pharmaceutical industry-from powerful new drug chemistries to innovative RD partnerships and marketing plans-are reshaping the business strategies of many phar maceutical and biotechnology companies Given these cost pressures it is understandable that the pharmaceutical companies are looking for better ways to market their drugs. The newest strategy is now to promote what is known as marketing blockbuster medical drugs directly to the consumer public. The idea was to empower the consumer. Right now only the United States and New Zealand allow pharmaceutical products promoted by DTC (Pharmaceutical Drug Manufacturers, 2011). When an individual consumer requests information and the medicine by name by their Doctor some of the responsibility while also applying pressure on the doctor to prescribe the new medicine. Additionally both the small and large pharmaceutical companies are now using digital media to promote their products. From TV and cable to Internet ads consumers are constantly being made aware of the virtues and minor drawbacks of a number specific pharmaceutical drugs. The reasoning behind this strategy by the pharmaceutical companies is relatively simple, if they can promote their products and make its trade name and cure synonymous with the ongoing medical complaint in the publics mind, then they can create momentum utilizing the end customer. Another reason for doing this is to get any of their major blockbuster drugs to pay for the company costs for their other company made drugs sold in smaller volumes Another reason for marketing these blockbuster drugs as to make a success of these drugs synonymous with the company name creating consumer goodwill towards the next product. The latest trend is for reduction in the number of blockbuster drugs and pharmaceutical companies delvin g back into their former research to find potential missing new specialized drugs, .this can be seen clearly by the reduction in applications to the FDA showing ever reducing numbers of new drugs. Another complication that pharmaceutical companies must contend with is the ever-growing number of over-the-counter substitutes (OTCs) that the consumers choose to purchase as an alternative. Over a period of 20 years Naprosyn was widely prescribed as an arthritis remedy but now is available as an over-the-counter drug. A whole spectrum of drugs from arthritis to antihistamines are now available without prescription providing relief to customers but adding little to the economic bottom line of pharmaceutical companies that originally developed these drugs. Another complication in drug marketing is the force exerted by HMOs on doctors and what doctors prescribe .Generally the majority of HMOs are not big on covering high prescription costs for new medicines recently brought to market. The economics are easily understandable because it is not about a single client which needs a single drug but the numbers are multiplied by the potential hundreds of thousands. Therefore HMOs seek to be conservative. And because of that they create a potential customer roadblock for pharmaceutical companies with the new drug on the market at a very high price. Because of the HMO will not cove r the price then the customer must, which generally means the consumer settles for less than the newest product. managed care organizations (MCO), compared with 5 per cent of the US population covered in 1980. These MCOs typically provided full coverage for prescription drugs. But, because of their sheer mass, these institutions had considerable bargaining power with drug companies If present industry overview is taken into consideration then the global pharmaceutical market in 2010 is projected to grow 4 6% exceeding $825 billion. The global pharmaceutical market sales is expected to grow at a 4 7% compound annual growth rate (CAGR) through 2013. This industry growth is driven by stronger near-term growth in the US market and is based on the global macroeconomy, the changing combination of innovative and mature products apart from the rising influence of healthcare access and funding on market demand. Global pharmaceutical market value is expected to expand to $975+ billion by 2013. Different regions of the world will influence the pharmaceutical industry trends in different ways. http://www.da-group.co.uk/index.php?option=com_contentview=articleid=31%3Amicro-and-macro-environmentscatid=2%3Amarketing-lecturesItemid=3 CURRENT CHALLENGES FOR THE RESEARCH-BASED INDUSTRY To understand why â€Å"business as usual†is no longer an option for the research-based drug industry, it is worth considering some of the myriad challenges that drug companies currently face. At the top of the list is the upcoming onslaught of patent expirations of many highrevenue- generating branded medicines. Between 2009 and 2012, worldwide sales for these products will exceed $112 billion (Table 1). Included in this list are 36 blockbusters (drugs with annual sales of $1 billion or more). Some important examples include Singulair (montelukast), with more than $4 billion in annual sales (patent expiration in 2012); Plavix (clopidogrel), with more than $8 billion in annual sales (patent expiration in 2011); and Lipitor (atorvastatin), with an industry-leading $13.7 billion in annual sales (patent expiration in 2010). Given that only 3 in 10 new products, on average, generate revenues equal to or greater than average industry RD costs,1 the loss of patent protection on the se blockbusters represents a very real threat to the industrys ability to sustain its own growth. Without question, many of the large pharma mergers and acquisitions announced in 2009 reflect the industrys desire to avoid the imminent danger of the patent cliff, rather than an interest in enhancing RD capabilities or scope. The current environment for innovation presents formidable economic, regulatory, and political challenges for the research-based pharmaceutical industry. In particular, the growing time, cost, and risk related to drug development are stubborn obstacles to filling industry pipelines and boosting the output of new pharmaceutical and biological products. Presented here is a model of an innovation network. Although structures may vary, the innovation network offers the best mechanism to ensure viability and economic success for all sectors of the pharmaceutical and biotechnology industry, as well as the uninterrupted flow of innovative lifesaving and life-improving medicines for waiting patients. The Rise of Contract Research Organizations Clinical trials are administered by investigators at hospitals, academic institutions or managed sites. The investigators find and enroll healthy and symptomatic volunteers, each of whom is required to sign an informed consent acknowledging acceptance of the drug and its potential side effects. The testing protocol and informed consent form are monitored by Institutional Review Boards (IRBs) in the sites where the trials are conducted. In essence, the IRB acts as an ethics committee to ensure the safety of patients and volunteers. Once clinical trials are completed, the data are subjected to biostatistical analysis over a 6 to 12 month period.3 If the data yield promising results, the sponsor seeks final approval though a New Drug Application (NDA). The NDA must contain all scientific information the sponsor has gathered and typically fills 100,000 pages or more.4 During the review period, the FDA assesses the safety and effectiveness of th e drug, the manufacturing process, and the risk-benefit calculus.5 By law, the FDA has 180 days to either approve the application or notify the sponsor of the opportunity to request a hearing on the merits of the application.6 In practice, however, the FDA review process takes more than two years; in 1996, for example, the mean approval time for NDAs was 17.8 months, down from over 30 months during the late 1980s.7 Following approval, the FDA may require additional post-market research. Post-market surveillance regulations require the sponsor to collect and periodically report additional safety and efficacy data.8 In addition, the FDA may request further clinical research (Phase IV) to find new uses for the drug, test dosage formulations, compare the drug to competitors treatments, and assess long-term effects.9 Finally, pharmaceutical Conclusions A continuous call for ethical standards by pharmaceutical companies that market in the United States is often put aside because company marketing and business model of making profits matter more.(Pharmaceutical Drug Manufacturer, 2011). Brezis (2008) writes that the US public will lose out in the long run because the pharmaceutical companies are more focused on marketing and profits than about public health. Drug trial deaths still happen and have been described as a trade secret. It is not just one of the big pharmaceutical companies by Johnson Johnson, Merick and others whose own safety documents raise concerns that are buried in stacks of papers while marketing continues (Brezis, 2008). But this is offset by the ability of both the doctor and patient to use the Internet to search out the detailed information and become truly informed. Each of them can then make an informed decision about the benefits and potential drawbacks of using pharmaceuticals.
Tuesday, September 3, 2019
Abortion By RU486 :: Argumentative Persuasive Topics
Dangers inherent in this method of abortion are evident in precautions used in other countries, for example France. The Food and Drug Administration based its 1996 finding that drug-induced abortion using mifepristone and misoprostol ("M/M") was "safe and effective" on results involving a subgroup of women (1,681) in French trials. M/M abortions in France are performed at government-operated hospitals and clinics, typically with or adjacent to emergency room facilities. Women are screened for numerous medical conditions that rule out use of the two drugs. Ultrasound is used to determine gestational age and to rule out tubal pregnancy. After women are given prostaglandin (e.g., misoprostol), they are monitored on site for approximately four hours so that allergic reactions, cardiopulmonary "events," hemorrhaging and the like can be treated promptly before they become life-threatening. A 1990 directive jointly signed by the French Republic's Director General of Health, Director of Hospitals and Director of Pharmacy and Medication, states that whenever prostaglandins are given "in association with RU 486" the "following technical conditions ... are indispensable and are to be followed: ... b) The doctor must ensure that diagnostic instruments and machines are close by, such as electrocardiogram equipment and particularly resuscitative cardiopulmonary equipment (including nitrous oxide and injectable calcium antagonists and a fibrillator). ... c) [C]linical observations and blood-pressure readings every half hour are indispensable for several hours following the administration of these drugs. d) Whenever there is ches t pain, an electrocardiogram should be taken on the suspicion of rhythm troubles and in case of significant lowering of blood pressure" ("Letter"). In Sweden, women are "supervised by the midwife for 4 to 6 hours at the outpatient clinic" (Bygdeman). In China "the emphasis on close medical supervision is well accepted. ... It is stressed that misoprostol should be taken in the clinic and followed by several hours of observation" (Wu). The long observation is one reason that staffs in some large hospitals in China are growing reluctant to prescribe the drug combination: "The number of medical abortions has decreased recently in some of the large hospitals. The staffs were too busy to handle the procedure (more counseling, more visits, and observation), and they also have to manage the referred cases with serious side effects and complications" (Wu 199). Searle, which manufactures misoprostol under the brand name Cytotec, has consistently opposed the use of Cytotec for labor induction and for
systems analysis :: essays research papers
Overview. The process is designed to handle the interaction with customers and suppliers, and also deals with stock control. Invoice and payment data is recorded. For clarity I have noted down the following: †¢Ã‚     Head Office consists of               -     Product Management                     Finance                     Sales †¢Ã‚     A Local Branch consists of     -     A Local Office                     Warehouse                     Distribution Preliminary List of Entities. In my top-down analysis of the Metropolitan Pharmaceuticals scenario, I have first attempted to produce a preliminary list of candidate entities. These are as follows: †¢Ã‚     Customer †¢Ã‚     Customer Order †¢Ã‚     Customer Invoice †¢Ã‚     Sales                    -     Occurs only once so isn’t included †¢Ã‚     Product †¢Ã‚     Product Order †¢Ã‚     Supplier †¢Ã‚     Supplier Invoice          †¢Ã‚     Finance               -     Occurs only once so isn’t included †¢Ã‚     Local Branch †¢Ã‚     Local Office               -     Is part of Local Branch so isn’t included †¢Ã‚     Distribution               -     Is part of Local Branch so isn’t included †¢Ã‚     Warehouse               -     Is part of Local Branch so isn’t included †¢Ã‚     Stock The following page shows my list of probable entities: List of Probable Entities. †¢Ã‚     Customer †¢Ã‚     Customer Order †¢Ã‚     Customer Invoice †¢Ã‚     Product †¢Ã‚     Product Order †¢Ã‚     Supplier †¢Ã‚     Supplier Invoice          †¢Ã‚     Local Branch †¢Ã‚     Stock Descriptions and expected essential attributes for the above entities: Since the system analysis is focused on dealing with customers, suppliers and handling products, I have included all entities which I believe participate in these activities. †¢Ã‚     Customer Description:     Retail chemist shops or pharmacies associated with shops, hospitals or medical practices. All require a supply of products from the Metropolitan Pharmaceuticals system. Attributes:          Customer ID               -     Identifying attribute Name                Address                Telephone Number                Fax Number                e-mail                Contact Name                Delivery Address                Credit Rating †¢Ã‚     Customer Order Description:     An order placed by the Customer requesting the delivery of product. Attributes:          Order Number          -     Identifying attribute                Customer ID Product ID Quantity †¢Ã‚     Customer Invoice Description:     An invoice sent to the Customer from the Finance department, requesting payment for the delivered goods. Attributes:          Invoice Number          -     Identifying attribute Order ID Date Amount to be paid †¢Ã‚     Product Description:     An item that is supplied by the Metropolitan Pharmaceuticals system. Attributes:          Product ID               -     Identifying attribute Name                Description                Category               -     (A,B,C or D)                Stock Item               -     (Yes or No) †¢Ã‚     Product Order Description:     An order that is sent to either the Supplier (if it is a non-stock item) or a Local Branch (if it is a stocked item), requesting the delivery of a product to a customer. Attributes:          Order Number          -      Identifying attribute Date Product Customer ID                Quantity †¢Ã‚     Supplier Description:     A company that is able to supply a range of products to Metropolitan Pharmaceuticals. Metropolitan Pharmaceuticals does not manufacture any of its products, but instead, uses suppliers who either produce or procure the products. Attributes:          Supplier ID               -     Identifying attribute Name Address Telephone Number                Fax Number                e-mail               †¢Ã‚     Supplier Invoice Description:     An invoice that is sent by the supplier to Metropolitan Pharmaceuticals requesting payment for the product it has provided. Attributes:          Invoice Number          -     Identifying attribute Date                Amount to be paid †¢Ã‚     Local Branch Description:     A local outlet that contains a Local Office, a Warehouse and a Distribution Center. Attributes:          Branch ID               -     Identifying attribute                Name                Address Telephone Number †¢Ã‚     Stock Description:     A full inventory of products that are held in stock at the local branch. Attributes:          Stock ID               -     Identifying attribute                Product ID Location               -     eg. Shelf number                Quantity                Re-Order level Entity Links or Dependencies. Now to identify which pairs of entities have an association between themselves. †¢Ã‚     Customer is related to Customer Order: Justification:     Customer places Customer Order Customer Order is placed by Customer
Monday, September 2, 2019
The Transformation of Psychology
The Transformation of Pyschology From the 1920s to today, psychology has surely developed. Technological advancements as well as new ideas and ways of thinking about the subject helped to reform what psychology is today. Rather than completely changing, psychology has actually built up more and more through the decades. New branches were added to the field as those who studied it made new breakthroughs. Over the years many scientists and psychologists have contributed to the transformation of psychology. Up until the 1920’s, psychology was defined as the science of mental life.It wasn’t until then that the idea of behaviorism became more prominent in psychology. During the time period between the 1920’s and the 1960’s, American psychologists led by John Watson redefined the meaning of psychology into a science of mental life and observable behavior. Not only did Watson redefine psychology, he also started the psychological school of behaviorism. It was als o around this time that Watson and his partner Rosalie Rayner conducted their conditioning experiment. The idea of classical conditioning came into play when behaviorism became a major branch of psychology.Between the 1950’s and 1970s, the mental perspective of psychology came back, producing another new branch. This new branch was called cognitive psychology. Cognitive psychology focused mainly on mental processes such as thinking, problem solving, memory, decision making, and language. The term â€Å"cognitive psychology†was first used in 1967 by the American psychologist named Ulric Neisser. To go along with cognitive psychology is the topic of cognitive development. This theory was concerned with the development of a person’s thought process.Jean Piaget published The Moral Judgment of Children which began his popularity as a theorist in cognitive development. As a reaction to behaviorism and psychoanalysis (a type developed by Freud, before the 1920s) , ano ther new type of psychology called humanism arose. Humanistic psychology stressed the importance of self-actualization and growth, and focused mainly on one’s potential. This new view on psychology was created by Abraham Maslow in the 1950s. He published Toward a Psychology of Being, in which he described humanistic psychology as â€Å"the third force†in psychology (behind behavioral and psychoanalysis).After the emergence of these new branches, psychology started to become more technologically advanced. Scientists and psychologists became interested in exploring the brain without removing it from subjects. They started to develop new technology. An example of this was in 1981, when a team developed the PET scan, which enabled doctors to view a computer generated image of the brain and when it is most active during certain mental activities. Today, technology continues to improve, which help psychologists discover more. Through the decades, psychology has undergone so me great changes.As new ideas came into play, new ways of thinking molded and shaped psychology into what it is today. Not only did psychology become a science of behavioral and mental life, but it also gained new branches that go even deeper. Psychology will most likely continue to grow and develop over the years. As technology advances, scientists and psychologists will discover even more and psychology will continue to expand as it did from the 1920’s until now.
Sunday, September 1, 2019
Genetically Modified Foods and the Labeling Debate Essay
There has been an ongoing debate between consumers and the government regarding the use of Genetically Modified Foods in the market today. â€Å"Since the introduction of the â€Å"Flavr Savr†tomato, biotechnology companies continue to introduce genetically engineered agricultural products to consumers†(Whittaker). The â€Å"Flavr Savor†tomato was the first food available to consumers that was produced using technology involving the recombinant DNA techniques in 1993. This was the dawn of a new generation in food production, and thus a whole new world of genetically engineered foods. At the present time the government, more specifically, the United States Food and Drug Administration (FDA) has not regulated labeling products that contain genetically engineered foods. Currently the policy for labeling all consumer products must meet the standards of the safety and nutritional assessment. The evaluations of genetically engineered foods by legal authority require that bioengineered foods must meet the same standards set forth for all imported and exported foods marked for human and animal consumption and according to the US FDA genetically modified (GM) foods meet these guidelines. Since the early 1990’s scientists has been researching new and improved techniques to bring plumper, juicer and insecticide resistant agricultural products to all consumers. But research such as this is nothing new to the scientific community and for over 50 years techniques have been used to create strains of wheat, rice, pears and many more crop species to create high yielding products that are capable of growing anywhere and anytime of the year. Currently, only one tenth of the world actually uses GM plants with the countries of Canada, US, Brazil and Argentina growing 90 percent of the GM crops (Freedman). With the majority of these crops being produced in North America, the US is seeing GM foods everywhere and this is drawing attention to different agencies and groups pushing to educate the public by labeling any products that contain genetically engineered foods. The US Food and Drug Administration has been dealing with the battle against labeling products with genetically modified organisms (GMO) for years, but regardless of the consistent scrutiny the FDA sticks firmly to the current regulations that govern the labeling of all foods for human and animal consumption. Under the Federal Food, Drug and Cosmetic (FD&C) Act, which drives the FDA’s safety regulations for food and food ingredients, â€Å"unless a significant safety risk exists or there is a sincere need for consumers to distinguish between food products before purchase, the FDA hesitates to mandate labeling of food products†(Leggio). Joseph A. Levitt, Director of the Center for Food Safety and Applied Nutrition with the US Food and Drug Administration states in his â€Å"Should the FDA Adopt a Stricter Policy on Genetically Engineered Foods? †testimony that â€Å"bioengineered foods and food ingredients must adhere to the same standards of safety under the FD&C act that apply to their conventionally bred counterparts†(Levitt, 81). With the strict laws set forth, the FDA remains consistent with its decision to maintain their current labeling program as it adheres to all safety standards of any food for consumption. The US FDA also assures the public that they have done significant research for decades on biotechnology foods to ensure it is safe for consumers, and additional testing is conducted years prior to the release of a GM product to the shelves. Scientists address all of the potential concerns to include the potential to adding new allergy causing proteins, removing vital nutrients and the possibility of introducing toxins, in these studies to ensure that unexpected results do not occur, â€Å"this testing provides a way to detect such changes at the development stage†(Levitt, 79) and it will also delay any release of products until they are able to find a solution. The FDA takes such precautions and studying all aspects of this technology to be confident that the risks are non-existent. Although the government has provided the public with research, publications, testimonies and scientific proof that the current law governing the labeling of food and animal products is appropriate and doesn’t require change, there is still much concern of the risks that the technology poses to humans. Barbara Boxer, a US Senator from California, introduced the Genetically Engineered Food Right-To-Know Act in 2001 in her testimony in â€Å"Should the FDA Adopt a Stricter Policy on Genetically Engineered Foods? †which states â€Å"all foods containing or produced with genetically engineered material bear a neutral label†(Boxer, 76). This act was created based on the lack of data and concerns that GM products are introducing risks of exposure to many health issues to include food allergens, lack of nutrition and toxic ailments. These claims are legitimate, however, the US FDA does take precautions as stated by Joseph A. Levitt, specifically with these risks while conducting trials during the developing stages of the product. In 2011 there was a petition filed against the FDA which warranted the need for labeling of GM products. According to this petition â€Å"consumers are misled when food labels do not differentiate foods with known health properties from novel foods with unknown health consequences†(Burgaard). An example of such health concerns come from a study performed in Scotland at the Rowett Institute in 1998. A plant biochemist named Arpad Pusztai conducted an experiment on rats who consumed a genetically engineered potato and his experiment concluded that the rats that were fed the modified potato â€Å"suffered growth and immune system-related changes†(Freedman). Ironically, the genetically modified potato used in this study â€Å"was not intended for human consumption  it was, in fact, designed to be toxic for research purposes,†(Freedman) discrediting the research altogether. Additionally, â€Å"American Medical Association, the National Academy of Sciences, the World Health Organization, and more than twenty-five Nobel Prize-winning scientists have concluded that there is no scientific evidence that GM food carries any risk to human health and that genetically engineered crops are safe,†(Burgaard) which ties into the overall nutrition and safety assessment that genetically engineered foods meet the same standards that imported and exported foods at held too. In the end, the US Food and Drug Administration stands by the current law governing the policy on labeling genetically modified foods. They maintain their standing on mandated labeling even under the microscope of doubters, but most importantly the â€Å"FDA’s process for evaluating bioengineered foods is one in which the public can have confidence that food biotechnology products must meet the law’s safety standards†(Maryanski). The FDA cares deeply of the health and wellbeing of the consumers in America and strive to meet the needs of the public in both food and nutrition education. Until the studies show significant risks or changes in the GM products warranting the need to readdress the process, the government and the US Food and Drug Administration believe their approach is relevant and remain firm to the present policies. Annotated Bibliography Whittaker, Michael A. â€Å"Reevaluating The Food And Drug Administration’s Stand On Labeling Genetically Engineered Foods. †San Diego Law Review 35. 4 (1998): 1215. Academic Search Premier. Web. 2 Jan. 2014. This journal review argues that the United States Food and Drug Administration (FDA) must reconsider its position on the labeling of genetically engineered food as well as consumer perceptions of the threat posed by genetically engineered foods. Freedman, David H. â€Å"Are Engineered Foods Evil?. †Scientific American 309. 3 (2013): 80-85. Environment Complete. Web. 2 Jan. 2014. This article discusses the debate over the safety of genetically modified (GM) crops. It covers comments from agricultural and environmental economist at the University of California, Berkeley, David Zilberman, on the benefits of GM foods compared to their health risks, a ban on GM crops by the European Union (EU), and the difference between selective plant breeding and mutagenic techniques. Leggio, Kelly A. â€Å"Limitations On The Consumer’s Right To Know: Settling The Debate Over Labeling Of Genetically Modified Foods In The United States. †San Diego Law Review 38. 3 (2001): 893. Academic Search Premier. Web. 3 Jan. 2014. This journal review supports the decision of the United States Food and Drug Administration (FDA) to reject mandatory labeling of genetically modified foods as a solution to accommodate consumer fears. There is a description of an approach designed to evaluate whether mandatory initiatives are appropriate to protect consumer’s right to know and the importance for states to follow guidelines established by the FDA. â€Å"Should The FDA Adopt A Stricter Policy On Genetically Engineered Foods? PRO/CON. †Congressional Digest 80. 3 (2001): Pages 76-95. Academic Search Premier. Web. 2 Jan. 2014. This is a two part article that discusses genetically engineered foods and the potential need to adopt a more strict policy. The articles provided information from the perspective of the US Food and Drug Administration (FDA) Joseph A. Levitt, the director of the Center of Food Safety and Applied Nutrition and US Senator, Barbara Boxer who speaks on behalf of the Genetically Engineered Food Right-to-Know Act and additional interviews that were conducted to give the audience an overall understanding of both sides of the debate. Burgaard, Sudhir. â€Å"The Labeling Of Genetically Modified Foods Debate. †Natural Resources & Environment 28. 1 (2013): 55-57. Environment Complete. Web. 2 Jan. 2014. This article focuses on the debate on labeling of genetically modified (GM) food which reflects food safety concerns in the U. S. It highlights various legal issues related to use of GM foods which includes increased risk of antibiotic resistant bacteria, increased use of pesticides, and environmental effects. It briefs the audience about the Center for Food Safety filing a legal petition with the U. S. Food and Drug Administration regarding labeling of genetically engineered food. Maryanski, . James H. , Ph D. â€Å"News & Events. †Genetically Engineered Foods. US Food and Drug Administration, 19 Oct. 1999. Web. 2 Jan. 2014. This testimony is from the perspective of the Biotechnology Coordinator with the US Food and Drug Administration (FDA) that discusses the current regulations governing genetically engineered foods and the process that dictates what and how determines what a DNA derived food is labeled. It includes a variety of examples that justifies the current labeling regulations and why GM Foods may not require additional information for the consumers.
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