Week 5 Notes

Question 1

What is the life cycle of a drug ?

Answer 1

1. Drug Discovery
2. Research/trials
3. regulatory approval
4. marketing and promotion
5. precription and consumption
6. post marketing surveillance

Question 2

Panapathogen

Answer 2

Negative unintended effects of a drug that lead to withdrawal of the drug from market

Question 3

Panacea

Answer 3

Positive/unintended effects may lead to a new drug life cycle (Asprin)

Question 4

Medicalization

Answer 4

the process by which nonmedical problems become defined and treated as medical issues, usually in terms of illnesses, disorders or syndromes

Question 5

how does medicalization elicit social control?

Answer 5

1. labelling of non medical aspects of life as either healthy/normal or unhealthy/abnormal
2. medicine defines social norms

ex. Sexual orientation is deemed a medical condition

Question 6

Pharmaceuticalization

Answer 6

the process by which social, behavioural, or bodily conditions are treated, or deemed to be in need of treatment/intervention with pharmaceuticals

Question 7

how does pharmaceuticalization elicit social control?

Answer 7

companies (through marketing and by influencing doctors) increasingly define what is healthy/unhealthy

• solutions are drugs

Question 8

Examples of Pharmaceutical control in society

Answer 8

Menopause defined as sickness (hormone replacement therapy)

shyness as a disease (psychotherapy and drugs)

Question 9

Pharm. industry is motivated by?

Answer 9

profits not altruism

ex. products are for treating illnesses in richer countries rather than infectious diseases in poorer nations

Question 10

“Me too” drugs

Answer 10

products that are similar to competitor drugs yet different enough that they can be patented and sold as a “new” drug

Question 11

Iatrogenesis

Answer 11

Any adverse outcome or harm as a result of medical treatment

• • caused by
    1. lack of oversite over drug companies
    2. the profit motive underlying pharm. companies

Question 12

example of iatrogensis

Answer 12

Thalidomide

Question 13

Pharmacovigilance (outcome of the Thalidomide tragedy)

Answer 13

the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

Question 14

smart regulation

Answer 14

regulating in a way that enhances the climate for investment and trust in the markets such that the admin. burden is reduced for business

Question 15

Risk Management

Answer 15

taking the known risks and benefits of a drug into consideration before allowing in onto the market. unless the product has seriously known risks, the preference is to allow it to be sold

Question 16

Precautionary Principle

Answer 16

not only taking into consideration risk of a drug but also potential risks even if the evidence for them is weak. decides is the product should be marketed or should be marketed under specific conditions

Question 17

How are drugs marketed?

Answer 17

1. direct advertising to docs through free samples
2. sponsoring medical conventions
3. “hospitality” to doctors