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Presentation on theme: " Q0SmDQ Q0SmDQ."— Presentation transcript:


2  Q0SmDQ Q0SmDQ

3  1. Observation  2. Hypothesis  3. Experimentation to test hypothesis  4. Analyze results  Statistical analysis (P values)  Accept or reject hypothesis  5. Publication and peer review  The scientific method helps to minimize the influence of bias in the experimenter

4  Are research papers perfect? NO  Paper that made huge strides in Alzheimer’s research was based on a single sample and was proven a hoax!






10  Codon – three nucleotides in a specific sequence (ACG, AGG, ATC, etc.)  A gene is a specific combination of codons (ACG-AGG-ATC, etc.)  Each codon represents a specific amino acid, which can be used to construct proteins

11  A gene patent is a patent on a specific gene sequence, its chemical composition, the processes for obtaining or using it or a combination of these  In the United States, patents on genes have only been granted on isolated gene sequences with known functions and these patents cannot be applied to naturally occurring genes in humans or other naturally occurring organism  Status quo - you can only patent a gene if you create it!  THW Abolish Gene Patenting  THW allow individuals to patent their genes

12  X2G58 X2G58  Stem cells are unprogrammed cells and have the potential to become any type of cell based on the environment they’re put in  Could be used to replace lost cardiac cells (in the heart) or lost neurons (in the brain) to counteract heart attacks and neurodegenerative diseases like Alzheimer’s or physical trauma like spinal cord injury  THS the creation of stem cell banks

13  Embryonic stem cells:  Derived from the inner cell mass of a blastocyst, which is an early stage embryo  There are currently no approved treatments using embryonic stem cells  Is it morally wrong to harvest the cells of an unborn child?  THW prohibit research that uses embryonic stem cells

14  Adult stem cells:  Found in umbilical cord blood, bone marrow, the olfactory bulb and some areas of the brain  Most adult stem cells are multipotent, meaning they are lineage-restricted in their development  Have been successfully used to treat leukemia and related bone/blood cancers through bone marrow transplants  Research is not controversial because production does not require the destruction of an embryo  In the United States, stem cell research is allowed by the Democrats, but has historically been banned by Republican presidents

15  Biological material derived from humans can be patented if it has been sufficiently transformed  Cancer patient, John Moore, sued the University of California  Cancer cells had been removed from Moore as part of his medical treatment – these cells were manipulated by researchers and patented by the University  John’s cells have since become widely used research tools without his consent  From the recesses of Alex Amar’s twisted mind:  THBT individuals should be able to own their tissue

16  Prior to 1938 standardized regulations for drug trials did not exist  1938 – sulphonamide antibacterial drug dissolved in solvent was introduced into therapeutics in United States  100 deaths occurred  1962 – sleeping tablet thalidomide was introduced  Found to cause fetal malformations during pregnancy  Negative effects were due to a reactive optical isomer

17  Pharmaceutical manufactures must:  1. Submit proof of safety and efficacy of drug in several animal species to the government regulatory agency in country concerned  2. Detailed methodology of proposed clinical trial in humans  3. Pharmaceutical manufacturer’s submission is evaluated by scientists from regulatory agency

18  Phase 1 – study conducted on limited number of healthy volunteers  Phase 2 – Determine whether drug is effective in treating condition it was designed for in limited number of people  Attention paid to safety  Phase 3 – Drug tested on large number of people (~1000)  Safety of drug still considered  Drug is released  Phase 4 – Risks that are delayed or less frequent in 1/1000 may be missed in Phase 3  Postmarketing surveillance

19  Is very stringent  Takes a long time ~ 10 years and millions or billions of dollars  Many Canadians and US citizens have gone to India to receive experimental treatments for diseases like multiple sclerosis

20  Past decade has seen an increase in use of herbal preparations  Estimated sales in Canada are 1-2 billion dollars annually  Phenomenon driven by two factors  1) Desire of public to use natural products, which they believe are safer than conventional medicine  2) Manufacturers and retailers who promote products for financial gain

21  Not subject to approval process  Exist in an unregulated market  There is no quality control between products  Effects are unproven  A prescription is not required  Side effects may be severe  Amygdalin  Europe has regulations controlling manufacture and testing of herbal products  Canada introduced regulations for herbal products in 2004, but they have not been widely enforced  THW allow doctors to provide alternative medical treatments

22  1) Lack of efficacy data  2) Lack of standardization and quality control  3) Undeclared ingredients  4) Intentional adulteration  Add hydrocortisone, a non herbal product to make herbal remedy seem effective  Add opium to make herbal remedy addictive  5) Source is questionable  Manufacturing facilities/processes not inspected  6) Confusing literature  7) Toxicities  8) Drug interactions with conventional medicine

23  Placebo – an inert substance which masquerades as a drug  Placebos have traditionally been used in drug trials as a control or administered to patients who demanded a drug when none was available  (Good) drug trials are double blind  Patients don’t know if they are receiving placebo and researchers don’t know who is receiving placebo

24  Beecher in 1955 conducted a study on placebo effect  ~1000 patients examined for a variety of conditions (i.e. angina, the cold, anxiety and tension, cough, mood changes, headaches, seasickness and postoperative wound pain)  Found satisfactory relief in 35% of cases  Interestingly, asthma, hypertension and mental depression also responded to placebo effect  THW allow doctors to prescribe placebos

25  Amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease is rapidly progressive muscle atrophy  There is no cure or treatment options  Over time, patients lose ability to speak, walk or move any part of their body  Most ALS patients die of respiratory failure  Their mental faculties remain completely in tact  Drug was developed that was a potential cure for ALS  No patient wanted to receive the placebo…

26  Are they evil?  Some of them are  Monsanto is regarded as the most evil organization on the planet  Really they are just profit maximizers like any other corporation  Corporations are largely amoral actors

27  Roundup ®  Herbicide based on glyphosate  “MONSANTO IS SPRAYING POISON ON OUR FOOD!”  Actually, they inhibit a specific enzyme that plants need in order to grow (EPSP synthase) – similar to how antibiotics kill bacteria  Glyphosate is not violently toxic to people or animals  Glyphosate is bad if ingested directly or applied to skin  Available at Home Depot and Lowes

28  Roundup Ready Seeds ® - Roundup ® resistant seeds  Terminator seeds  Seeds produce infertile plants with no seeds  Farmers would be forced to buy seeds from Monsanto for each harvest  Not available for purchase at present time

29  Farmers who use transgenic Monsanto seeds to grow crops agree that they will not plant harvested seeds as a condition of purchase  Chancellor’s Semifinals - THW not allow patenting of living organisms

30  Over time, virtually all crops have been genetically altered in some way  Cross breeding, replanting best crops, etc.  Bananas have been genetically engineered through selective breeding to not have seeds  Why is altering crops in a lab different? Isn’t it just a more efficient means of genetic modification?  There is nothing inherently dangerous about GMOs  THO GMOs  THW require all GMOs to be labelled on food packages

31  Genetic manipulation allows us to add in genes that are not endogenous to a particular species  Can fortify foods with additional vitamins and nutrients  Golden rice  Beta-carotene, a precursor of vitamin A has been added to the rice through genetic engineering  Vitamin A deficiency kills 670 000 children under 5 each year  Golden rice was developed as a humanitarian tool, but has encountered widespread opposition from environmental activists… so silly

32  Patent – a grant of a property right issued to the inventor by the patent and trademark office (i.e. intellectual property)  Copyright – authors original work (i.e. literature, music, art, etc.)  Trademark – original word, name or symbol used in trade to indicate source of good (i.e. Apple Inc.)

33  Grants exclusive use  Can be licensed out  Last 20 years from filing date, but because clinical trials often take ~10 years, only guarantee about 10 years of market dominance  Patent extensions may be granted on a case by case basis  Advancements or new research  Delays in production

34  It’s not free!  Hospitals do not buy their own supplies  Group Purchasing Organizations are responsible for buying all hospital supplies

35  Operate independently of hospitals  Initially created to leverage purchasing power for hospitals (Costco Theory) and ensure hospitals always received the supplies they needed  Originally hospitals paid membership fees into the GPO  system was fine  System changed when GPOs started to receive contract payments and bonuses from suppliers  GPOs became loyal to suppliers and not hospitals

36  Relationships between GPOs and suppliers became entrenched  So much so, that entry into the market is almost impossible  Retractable needles… they’re so good… why aren’t they in hospitals…?

37  Physician-patient privilege or patient confidentiality– protects communications between patients and their physician from being used against the patient in court  Trust is important – if the patient does not trust the doctor, the doctor is operating under imperfect information – the patient may receive inadequate treatment  Physician-patient privilege does not exist in the United States!  THW force doctors to report abuse

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