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Recombinant Bovine Growth Hormone
Transcript of Recombinant Bovine Growth Hormone
Job outline of Biotech Regulatory Affairs Director/ Manager with the J. R. Simplot Company from
References GeneticRoulette. (2008). "Your Milk on Drugs - Just Say No 1/2 and 2/2." Youtube.com Retrieved 16 November 2012 from http://www.youtube.com/watch?v=_GpqwZDbMHU.
http://www.youtube.com/watch?v=lMBHNKhlw9M. Dilemma with rBGH rBGH does not alter the lactose that is being produced under the influence of the drug recombination is the process where a wanted gene is selected from the original animal and inserted to the plasmid of a bacteria
the bacteria is then grown with the new modified plasmids inside of it the purpose of this is to replicate the wanted gene in large quantities after growing the bacteria colony, you can then move on to add the bacteria to different host organisms and allow the gene to become active rBGH stands for Recombinant Bovine Growth Hormone The word rBGH can be used in exchange for Recombinant Bovine Somatotropin (rBST) it can now be used
ie. distributed to diabetic patients if the gene was insulin a complete realistic example is shown: creating rBGH is the same process, however we use the Bovine Growth Hormone gene from cows in the 1980s, biotechnology advancements allowed the development of BGH commercially (through the DNA recombination process we just observed) to make rBGH how rBGH works rBGH causes the mammary tissue in the lactating cows to uptake more nutrients
rBGH alters the metabolism rate in other tissues so that the mammary tissue has the most attention
helps control the insulin-like growth factor (IGF-1) levels in the blood stream IGF-1 is produced in the liver and is a hormone responsible for the growth in childhood rBGH has been used in live cows since its approval by the US Federal Drug Administration (FDA) in 1993
the milk produced with the presence of rBGH can be seen for sale on the shelves in the markets of the United States of America (US) Here is a diagram: There are no changes in calcium, phosphorus, and mineral content in the milk The FDA concludes an increase in IGF-1 will unlikely present any human food safety concerns, as in increase in IGF-1 can be seen in people drinking non-rBGH produced milk
However, there are still unresolved questions about whether causes premature growth in children or causes breast cancer in women
There is more pus in the milk because the udder is infected
Physical Impact: Cows injected with rBGH develop more udder infections, called mastitis, than un-injected cows More antibiotic resistant bacteria come to be
and this has concerns for human health To help combat the infection, the cows are given more antibiotics Severe health and reproductive problems in cows treated with rBGH (Monsanto-commissioned study at the University of Vermont) Global Impact of Biotechnology Helping solve world hunger
Insulin can be produced through recombination, previously it was extracted from animals (much cheaper and more can be collected) Ex. Species of rice in China are genetically fortified with vitamins - is called Golden Rice Genetically modify crops, such as corn, to make them tougher and grow faster in less time Therefore there is more food produced in one season or the food produced benefits the consumers health needs Genetically modify a specific hormone to make a lactating cow produce more milk Pharmaceutical Industry Ex. Insulin for different diseases, potential to help defeat cancerous cells AKA Environmental Biotechnology ie biotechnology in living creatures, biotechnology in food production, biotechnology in uncontrolled environments, biotechnology for use in drugs Different dilemmas arise from different uses of biotechnology
FDA forgot to publish data on lesions and higher rates of infectious disease among treated cows and
stated that out of its 130 studies, there were no definitive health effects FDA have determined milk and meat are safe for human consumption, however... Questions arise about FDA regulatory processes; whether it permits marketing and scientific bias into results rBGH is best understood for its use in protein products rather than when its used in animals and for food products rBGH is biologically inactive in humans and rBGH and BGH are biologically indistinguishable
FDA published data on the safety of the drug before it had been approved for use FDA states after a 30 year studies; no increased health risks associated with the use of rBGH
in toxicology studies 5x the amount of recommended rBGH is used and there are no apparent adverse effects of the rBGH grocery chains and many food processing companies refuse to use milk from rBGH treated herds and it is not permitted for use in the European Union and in Canada
prostate, breast, colorectal cancer relations still unclear production company Monsanto threatened to sue companies who advertised rBGH free products
1998 legislative session in Vermont, Monsanto threatened to sue if a voluntary rBGH labeling bill became law
warned 2000 retailers and 4000 food processors that they cannot use a label of 'rBGH free' on their products sent a legal memorandum
The treatment of cows
Adults who drink rBGH milk have a 10% higher IGF-1 present in their blood but it doesn't seem to be doing anything also, people who drink soya milk have this increase too also stated that rBGH is very unlikely to be active in humans; not active when injected into children with dwarfism due to a lack of growth hormone -responsibility for developing and implementing a regulatory strategy, in addition to leading efforts for approval of biotech products in the U.S., Canada, Mexico, Japan and other countries as needed for export and trade protection
-interface and communicate with U.S. and International Governmental Regulatory agencies to ensure the smoothest path through regulatory for Simplot biotechnology products
-planning and executing all studies needed for regulatory approval
-hire and manage regulatory consultants who specialize in obtaining approval in each of the countries
-collaboration with biotech researchers to influence regulatory agencies regarding product safety with the goal of minimizing time and resources needed for approval Summary: -B.S. (M.S. or PhD preferred) in the Sciences, in Molecular Biology, Biochemistry, Genetics, Plant Physiology, Engineering, or other relevant majors.
-5 years of practical experience in the field of plant biotechnology. (required for Director level)
-10 - 15 years related experience and/or training, with at least 5 years in a biotechnology regulatory role. (10 years required for Manager level, 10+ required for Director level)
-Experience in the area of biotechnology is also desirable.
-Strong verbal and written communication skills.
-Knowledge and use of negotiation skills through executed agreements and collaborative research
-Supervisory experience and skills expected. Quinn, Elizabeth. "IGF-1 - What Is IGF-1 (Insulin-like Growth Factor 1)." Sports Medicine, Sports Performance, Sports Injury - Information About Sports Injuries and Workouts for Athletes. Sports Medicine, 18 Sept. 2011. Web. 24 Nov. 2012. <http://sportsmedicine.about.com/od/performanceenhancingdrugs/a/Igf-1.htm>. Guyer, C.G., & Juskevich, J.C. (1990). Bovine growth hormone: human food safety evaluation. Science. Retrieved November 12, 2012 from http://ic.galegroup.com:80ic/cic/AcademicJournalsDetailsPage/AcademicJournalsDetailsWindowdisplayGroupName=Journals&disableHighlighting=false&search_within_results=&prodId=CIC&action=2&catId=&document=GALE%7CA8872146&userGroupName=ko_pl_portal&jsid=ad3c6a2771374d4b2e18d8e50608bcd6 Gibbons, A. (1990). FDA publishes bovine growth hormone data. Science, 249(4971), 852+. Retrieved November 12, 2012 from http://ic.galegroup.com:80ic/cic/AcademicJournalsDetailsPage/AcademicJournalsDetailsWindow?displayGroupName=Journals&disableHighlighting=false&search_within_results=&prodId=CIC&action=2&catId=&documentId=GALE%7CA8872140&userGroupName=ko_pl_portal&jsid=99b0d3306721c52b10a46a59af3ab4ed
Douthitt, R., & Grobe, D. (1995). Consumer acceptance of recombinant bovine growth hormone: interplay between beliefs and perceived risks. Journal of Consumer Affairs, 29(1), 128+. Retrieved November 12, 2012 from http://ic.galegroup.com:80ic/cic/AcademicJournalsDetailsPage/AcademicJournalsDetailsWindow?displayGroupName=Journals&disableHighlighting=false&search_within_results=&prodId=CIC&action=2&catId=&documentId=GALE%7CA17036122&userGroupName=ko_pl_portal&jsidd=33c27239d2223c33619089c041d16152 Gorelick, S. (1998). Hiding damaging information from the public. The Ecologist, 28(5), 301. Retrieved November 12, 2012 from http://go..galegroup.com/ps/i.do?id=GALE%7CA21269228&v=2.1&u=ko_pl_portal&it=r&p=AONE&sw=w (2011). Recombinant Bovine Growth Hormone. American Cancer Society. Retrieved November 12, 2012 from http://www.cancer.org/cancer/cancercauses/othercarcinogens/athome/recombinant-bovine-growth-hormone