1
Q
what was the first “blockbuster” psychopharmaceutical with high consumption and large cultural impact in the general population? bonus! WHat’s the second called?
A
1st - Miltown
2nd - Valium
2
Q
What did biological psychiatrists believe about mental illness?
A
that it was primarily or entirely a biological phenomenon, rooted in physical dysfunction of the brain
- note! only a small minority believed in mental illnesses having biological cuases
3
Q
What theory grew in popularity?
A
- theories of chemical imbalance
4
Q
What did Senator Estes Kefauver do?
A
- led a high-profile investigation of the pharma industry
- which led to Kefauver Harris Amendment to the Federal Food, Drug, and Cosmetic Act
5
Q
What is the Kefauver Harris Amendment to the Federal Food, Drug, and Cosmetic Act?
A
- now. requires companies to demonstrate not just safety, but that they are “effective”
- BUT not more effective than existing or competing medications, just more effective than a placebo
EXTRA
- market filled with copy-cat medications replicating existing treatments
- even medications slightly better than placebo marketed as “miraculous” and transformational
- proliferation of psychopharmaceuticals only marginally more effective than a placebo partially due to lax restrictions
6
Q
What did Kefauver’s Act lead to?
A
- lead to the development of a large number of medications
7
Q
which countries marketed directly to the public in a limited number of settings?
A
- US and New Zealand
8
Q
Before it was used to treat ADHD, what was Ritalin used as?
A
antidepressant
9
Q
What was the next wave of blockbusters?
A
- Xanax (benzodiazepine)
- Prozac (SSRI)
10
Q
What was Ritalin re-conceptualized as?
A
- the frontline treatment for ADHD, where it was formerly used as an antidepressant
11
Q
What was Adderall rebranded as?
A
- became an ADHD medication, after being formerly used as an anti-obesity drug
12
Q
What were the functions of the decision to sidestep the causes of illness in DSM-III and to focus on symptom checklists?
A
- to boost biological psychiatry
- reinforce the use of medications to treat the symptoms listed as criteria for disorders
- ex. checklist for depression developed while being aware of the effects of medications used to treat them and these effects informed symptom list
13
Q
What did the political climate in the US, Canada, and UK favour in the 1980s?
A
- smaller government and more market-driven policy that also boosted biological psychiatry
- drug patents became more profitable, driving marketing and sales
14
Q
What did the health systems’ pressure on physicians to treat more patients in shorter amounts of time lead to?
A
- higher rates of prescribing as a response to mental illness
- bc psychotherapy was time-consuming
- ex. fee-for-service, more customers = more $
15
Q
What is disease-mongering?
A
- a marketing strategy by pharma companies to sell the idea of particular diseases to consumers and then offer a solution (medication)
- coined by David Heally in 1997
- sell disease to grow patient population and develop markets, maximizing perceived prevalence and severity of mental illness by subtly redefining who was deemed to have mental illness symptoms
16
Q
what were some critics on disease-mongering?
A
- medicalized normal human experiences and diversities
ex. shyness became characterized as an “anxiety disorder”
17
Q
What did Peter Conrad argue about disease-mongering?
A
- argued that since the 1990s pharma companies played a greater role in defining what gets counted as illness, where it was physicians before
18
Q
give example of disease-mongering
A
Food and Drug Administration’s (FDA) approval of Xanax as a medication for social anxiety disorder, transformed shyness into a “disorder”
- Similar pattern with generalized anxiety disorder, attention-deficit hyperactivity disorder, and binge eating disorder
19
Q
Who experienced an increasing number of overdose episodes and dependence to Valium?
A
- american women
20
Q
What did feminists argue about valium?
A
- argues that it was being prescribed to women for conditions that were social problems (fatigue, nervousness, anxiety - which stemmed from gender roles and relations) rather than mental illness
- these concerns led to changes in the regulation and marketing of Valium
21
Q
How much did antidepressant use increase in the US between 1988 and 2008?
A
400%
22
Q
What is the 3rd most common prescription among Americans aged 18-44?
A
- antidepressants
EXTRA
* 11% of Americans filled a prescription for a daily antidepressant
- 7% of Americans received a monthly antidepressant prescription for 2 or more years consecutively
* Approx. 14% of Americans taking antidepressants have been taking them for 10 years or more
* Widely prescribed and consumed, use is very prevalent, and often long term
23
Q
Do you think there was a 400% increase in the prevalence of depression in 20 years? why or why not?
A
- internationally, women are twice as likely as men to use psychiatric drugs
- no bc of the marketing/awareness and distribution of these drugs, and the awareness of depression and mental health
- yes bc less likely to seek help around this time (stigma
24
Q
What do all drugs have?
A
- chemical, generic and trade name
25
Why do some drugs have multiple trade names?
- depended on marketing teams
- different jurisdictions
26
who were trade names developed by?
- by marketing departments within pharma companies
27
How is drug naming organized in North America
- by families of diagnostic symptoms they alleviate
◦ If a drug alleviates symptoms of depression, we call it an antidepressant
◦ If a drug managed symptoms of psychosis, termed an anti-psychotic
28
What is another approach in naming drugs
- focusing on chemical structures or the neuroreceptors targeting
extra.
Name based on chemical structure:
* Benzodiazepines: diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan)
* Tricyclic (3 fused rings) antidepressants: imipramine (Trofranil), amitriptyline (Elavil)
Named based on neuro-receptor targets:
* SSRIs (selective serotonin reuptake inhibitors): fluoxetine (Prozac), sertraline (Zoloft)
* Dual reuptake inhibitors (serotonin-norepinephrine reuptake inhibitors): venlafaxine (Effexor), duloxetine (Cymbalta)
29
What are the 3 antipsychotics that includes reference to neurochemical mechanisms
* Dopamine receptors: haloperidol (Haldol), flupentixol (Fluanxol)- sometimes called
D2 blockers
- typical (first generation) antipsychotics (1950s-60s)
* Atypical (second generation) antipsychotics (end of 20th century): olanzapine (Zyprexa), quetiapine (Seroquel), aripiprazole (Abilify)
30
What are some medications that are not singularly classified or single purposed
* Fluoxetine is simultaneously an antidepressant and an anxiolytic (antianxiety)
* Aripiprazole is listed as an antidepressant and antipsychotic
* Quetiapine is classed as an antidepressant, antipsychotic, and mood stabilizer
**Not meant to indicate any medication is more effective than the others, but that they are used for multiple purposes
31
What impression do some names and classifications give?
impression that particular conditions (like depression) are "concrete" disease states
- the lines between disorders and illnesses are not clear-cut and may evolve
32
What are the 3 frameworks that are commonly used to help us make sense of what is observed clinically?
- consensus statements
- evidence-based medicine
- causal reasoning / pharmacological reason
33
What is the consensus statement
- approach developed by the US NIH (national institute of health) in the 1970s
- producing guidelines for clinical treatment and care of particular conditions
34
What is another name for consensus statements
sometimes called "treatment guidelines:
35
What is the evidence-based medicine framework?
- developed at McMaster Uni
- ranks medical knowledge and research according to the level of evidence supporting the knowledge, largely related to the method used to generate findings
36
What is the highest level of authority for evidence-based practice
large clinical trials
37
What is phase 3 clinical trials
where manufacturers demonstrate "efficacy" of medications
38
What is the diff between efficacy vs. effectiveness?
- effectiveness refers to effect in the real world outside of trial conditions when there are more complicating factors in the environment and due to context
39
What is phase 1 of clinical trials
trial tests an experimental drug on a small group for the first time
purpose:
- look at the drug's safety
- find out the safe dosage range
- see if there are any side effects
40
what is phase 2 of clinical trials?
drug is given to larger group (usually 100 ir mire)
purpose:
- gather data on how well it works to treat a disease or condition
- check the drug's safety on a wider range of people
- figure out the best dose
41
what is phase 3 of clinical trials?
- drug is given to even larger group (1000 or more)
purpose
- make sure it is still effective
- monitor side effects
-compare it to commonly used treatments
- collect info about the drug that will allow it to be used safely on the market
42
what is phase 4 of clinical trials
- take place after the drug is approved and is on the market
- info is gathered on things like the best way to use a drug and the long-term benefits and risks
43
What is causal reasoning?
- pharmacological reason
- process where physicians consider a patient's response to a medication as a part of the process of arriving at a diagnosis
- if patient responds to antidepressant, then they may be diagnosed with depressoin
- not trial and error, it is trial and observation
44
what does causal reasoning promote?
- promotes off-label prescribing and polypharmacy
45
give example of causal reasoning
Atypical depression, thought to be a subtype more responsive to MAOIs than tricyclic antidepressants
* In the 1970s psychiatrists thought individuals who felt better if taking a MAOI could be confidently diagnosed with atypical depression
46
explain atypical depression
- individual's ability to feel brighter about positive events (opposed to melancholic depression who have lower mood despite events and situations)
- increase appetite, sleep more than usual, felt "leaden paralysis" (a heavy sensation in the limbs)
- more sensitive to feelings of rejection than people experiencing melancholic depression
47
What are the 3 ways of causal reasoning?
- off-label prescribing
- polypharmacy
- de-prescribing
48
explain off-label prescribing
refers to the use of medications for reasons not officially approved by drug regulators, accounts for a significant proportion of prescribing in North America
* As it has grown, the number of people taking multiple psychiatric drugs has increased
49
explain polypharmacy
a medical term referring to the simultaneous use of 5 or more prescription drugs (not all psychiatric, but psychiatric medications are often a component of these combinations)
* Example: taking a blood thinner, a blood pressure medication, 2 HIV anti-retroviral medications, and an anti-depressant or anti-anxiety medication
* Concerns about safety and efficacy with polypharmacy: combinations may be complicated, and interactions need to be considered and monitored
50
explain de-prescribing
a term that began appearing in medical journals around 2003 partially due to concerns about unforeseen adverse effects stemming from combinations
* And special problems also arising from reducing medication, particularly among the elderly
51
What are some assumptions underlying the use of psychiatric medications?
* Psychiatric illnesses “exist in nature” and have a natural course of illness
◦ A certain path biological processes follow as a person tries to re-achieve baseline functioning
◦ Important, however, to be mindful that syndromes are idealized models of a particular diagnoses, individuals differ in their presentation, experience, and trajectories
* Medications may be used to optimize a persons’ baseline functioning (improve focus or attention)
* Or modify long standing tendency to low mood or low energy among individuals who never experienced the full syndrome of major depressive disorder
52
What are 2 ways conditions can be characterised as?
- acute or chronic
53
define acute
direct response to loss, trauma, physical illness, toxicity (can point to a cause) (Death)
* Plausible cause and brief treatment
* Relieve symptoms like anxiety, insomnia, or psychosis
* Treatment is intended to be brief (weeks/months) and will end when symptoms end (remission)
54
define chronic
Wax and wane, treatment may be long-term, even life-long (maintenance therapy)
- persistent
* Example: major depressive disorder
55
review this about major depressive disorder
* MacArthur Foundation Research Network on Psychobiology of Depression: framework for authoritative language of prescribing
* Acute phase: corresponds to use of treatment to achieve remission (determined by standardized rating scale)
* Once symptoms resolve: continuation phase (16-20 weeks following symptom remission)
* Maintenance phase: remaining symptom free for more than 20 weeks, deemed “recovery”
56
What is maintenance therapy
- practice of prescribing medications for extended periods, or lifetime
- the use of medications to achieve maintenance of remission
* Often recommended for specific syndromes: Major Depressive Disorder, Bipolar Disorder, Schizophrenia, persistent depressive disorder, obsessive-compulsive disorder, panic disorder
57
What is a disadvantage of maintenance therapy
* A disadvantage of this approach is that it labels the people using these medications as chronically, permanently ill (describing these conditions as persistent rather than chronic is less stigmatizing)
58
When are discontinuation trials used
used to determine when and how people can stop using maintenance therapies
◦ Textbook definition: A form of randomized control trial that involves two stages. In stage one, all participants receive active medication. In stage two, participants who have responded to the treatment are randomized and some begin to receive placebos.
59
What are the formal and informal marketing strategies used by pharmaceutical companies
- funding research
- branding
- tv commercials where legal
- celebrities/movies
- samples to physicians
- targeting physicians
60
What is the duel nature of psychopharmceuticals
- they are medications but also commercial products (commodities) intended to produce profit for pharma corporations
61
How is the cause of most mental disorders elusive?
- some medications developed intentionally/purposely, others by accident
extra:
* Chlorpromazine (as first psychopharmaceutical) originally tested for surgical patients
* MAOIs originally thought of as an anti-tuberculosis medications, later used for treating depression
* Drug discovery is complex unpredictable process, perhaps different from other parts of medicine, partially due to lack of clear biomarkers
62
What 3 countries require demonstration of safety and efficacy prior to approval?
- US, Canada, European Union
63
review this
The process of developing a psychiatric medication is expensive
Millions invested, need to recoup costs of clinical testing (trials) and R&D efforts to generate profits
* Physicians are central in this campaign, must be confident in prescribing * Public must feel it is safe and beneficial to consume it
64
What are some concerns about advertising and attempts to influence physician decision-making?
* Generally advertising of prescription drugs is through specialist venues (conferences, medical journals) not regularly accessed by the public
* Public lacks specialized knowledge and awareness to make judgments about medications
* Individual anxieties regarding illness may preclude objective decision-making and impair rational decision making
* Medical drugs are not normal consumer goods, but extraordinary commodities- which require different regulations and governance
65
review educational ads
* Pharma makes “educational” ads: informing individuals to help them make decisions about their own care
* Critiques: more harm than good, misleading messages about benefit and efficacy, resulting in demand and price increases
* A prominent process of medicalization
66
Should Canada allow direct-to-consumer advertising of prescription drugs?
No? bc of the toxicity and the potential for harm from medically unnecessary or inappropriate use
67
define antipsychotics
- medications believed to explicitly combat the symptoms of psychosis
68
define direct-to-consumer advertising
- a practice formally legal in only 2 countries, whereby ads are aimed at those who will ultimately consume medications, rather than at the physicians who prescribe them
69
define SSRI
- selective serotonin reuptake inhibitor
- type of drug, often prescribed as an antidepressant, designed on the assumption that depression results from low levels of the neurotransmitter serotonin
70
define tranquilizers
- medications that generally impact a person by sedating or calming them, including both major and minor tranquilizers
HSCI 214
flashcards
Decks in class (25)
# Cards
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Lecture 247
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Lecture 325
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Lecture 429
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Lecture 532
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Lecture 670
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Lecture 727
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Lecture 813
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Lecture 928
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Lecture 1052
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Tutorials16
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practice questions17
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Lecture 1344
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Lecture 1455
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Lecture 1526
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Lecture 1622
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Lecture 1733
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Lecture 1859
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Lecture 1926
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Lecture 2063
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Lecture 2130
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Lecture 2260
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Lecture 2319
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Lecture 2426
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Lecture 2520
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Tutorial 21
