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SCIENCE

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SCIENCE

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Scientific Method

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

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Scientific Method

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!

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Gregor Mendel, the father of genetics

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Mendel’s Model

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The genomes of humans and chimpanzees differ by only a small

percentage of nucleotides (1%)

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Chromosomes and DNA

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DNA

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Genetics – Terminology

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

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Gene Patenting

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

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Stem cells

https://www.youtube.com/watch?v=HT1GzjX2G58

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

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Stem cells

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

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Stem cells

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

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Stem cells and patents?

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

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Clinical Trials

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

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Clinical Trials

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

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Phases of Drug Trials

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

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Drug Approval

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

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Alternative Medicine

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

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Alternative Medicine

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

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Problems with Herbal Remedies

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

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Placebos

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

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Placebo Effects

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

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Ethics of Placebo

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…

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Pharmaceutical and Biotech Companies

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

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The Monsanto Product Line

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

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Monsanto Product Line

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

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Monsanto and Farmers

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

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Genetically Modified Organisms (GMOs)

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

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Genetically Modified Organisms (GMOs)

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

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Intellectual Property

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.)

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Patents

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

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United States Healthcare

It’s not free! Hospitals do not buy their own supplies Group Purchasing Organizations are

responsible for buying all hospital supplies

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Group Purchasing Organizations (GPO)

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

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Group Purchasing Organizations (GPO)

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…?

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Doctor-Patient Relationship

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