Flashcards in Lesson A2 - DRUG ADVERTISING, DRUG TRIALS, AND PLACEBO EFFECTS Deck (36):
A considerable portion of the revenue required for the publication of medical journals is obtained from _________________
What are the 6 steps of advertising techniques?
1. Catch audience attention
2. Use celebrities or authorities to endorse products
4. Offering an easy solution to the problems
5. Before-after technique
6. Discredit drugs produced by other manufacturers and praise your own.
What step is this in the advertising techniques? Lincocin offers you a "leading edge" over penicillin in streptococcal infections
- Catch audience attention
- Lincocin → later shown to have severe adverse effects → no longer used
What step is this in the advertising techniques? If the authorities chose it → it must be the drug of choice
Use celebrities or authorities to endorse products
What step is this in the advertising techniques? " Every fourth menopausal women may develop osteoporosis OS Cal can help" → inflicting fear that these women may develop hunching over ect.
What step is this in the advertising techniques? " Problem child or child with a problem?"
- Offering an easy solution to the problems
- This type of advertising has been banned
What step is this in the advertising techniques? " When osteoarthritis to interfere" → Shows unhappy women → and then shows the same women happy
What step is this in the advertising techniques? " This is no time to have to worry about your antihypertensive But the potential risks of diuretics could make it just the time for lopressor SR
- Discredit drugs produced by other manufacturers and praise your own.
- Implies beta blockers are a better choice (lopressor SR = beta blocker)
What are the two most common drugs used in hypertension (blood pressure)
Diuretics + Beta blockers
What drug introduced in 1938 ( Not many regulations) caused 100 deaths
sulfonamide --> turned out to be toxic
What was the drug introduced in 1962 that caused birth defects in pregnant women and what was it suppose to be used for
Thalidomide (sleeping tablet)
What was thalidomide used for and what did it cause?
- Sleeping pill
- Caused birth defects when pregnant women took it
How were drug regulations further strengthened?
Drug company's required to show evidence of both safety + efficacy (effectiveness)
What are the 3 steps that a pharmaceutical company has to undergo if they want to introduce a new drug?
- 1. Submit proof of both the safety + efficacy of the drug in several animal species
- 2. Detailed methodology for the proposed clinical trial in humans is required
- 3. Submission carefully evaluated → If regulatory agency is satisfied → permission will be given to for an highly qualified investigator to initiate investigations in humans
How many phases are there in a clinical trial?
What does phase 1 entail in a clinical trial?
Study conducted on a limited number of healthy volunteers → absorption, distribution, elimination and adverse effects of the new drug is carefully studied
What does phase 2 entail in a clinical trial?
Check if drug is effective → close attention is paid to the safety of the drug (proof of concept)
What does phase 3 entail in a clinical trial?
Drug tested in a large number of people → usually 1,000 or more → safety + efficacy is tested → if found to be safe + effective → realeased for marketing and testing
What does phase 4 entail in a clinical trial?
Risks that are delayed or less frequent than 1 in 1000 my be missed in phase 3 → drugs under surveillance after release for general use → postmarketing surveillance
_________ is an inert substance which masquerades as a drug → derived from latin " shall I please"
Why were placebos administered?
Because sometimes in the past some patients demanded therapy even when there wasn't any available → therefore placebos were administered
______________ are effects which occurs as a result of drug administration and have nothing to do with the pharmacological effects of the drug
- Beecher 1955 → conducted one of the most comprehensive studies of placebo effects → roughly 1,000 people involved → Found satisfactory relief in ____% of patients
What conditions that have been found to be responsive to placebo?
asthma, hypertension, mental depression
In placebo treatment people still report ___________
Who is the placebo effect greatest in
- Greater in sick, anxious patients under stress than in normal volunteers
The Placebo effect is greatest in volunteers and less likely in sick, anxious patients under stress
wrong, it is the opposite
It is not ethical to compare a __________ to a __________ if there is an _____________ of proven value because individuals should not be deprived of ______________
New drug, placebo, older drug, effective therapy
People must be assigned ___________ to different ___________ or a flaw can exist in a trial
Randomly, experimental groups
What are 2 charasteristics of a Double-Blind Design
-1. Subjects should be unaware of whether they are receiving the new or old drug (or placebo)
-2. The clinical investigator should be unaware of whether the subjects is receiving the new drug or older drug (or placebo)
-This procedure is necessary in order to eliminate bias → on the part of the subject and the investigator
Valid clinical trials must be carried out in a ________________ manner in order to eliminate bias
Method of comparison of new drug with an older drug (Or with placebo if there is no drug available)
Design of a phase 3 study (comparative efficacy trial)
What is it called when we divide individuals into two groups randomly. Group A receives the new drug and group B receives the older drug (or placebo). Then you compare the effects of the treatment. You then do the exact same thing but group A gets the older drug ( or placebo) and Group B receives the new drug.
What is the type of trial that can be used in diseased states that are chronic and stable. Limited application ( not used very often)
What is it called when a subjects are divided into two groups and one group receives the new drug and the other group the placebo or established drug → Most phase 3 studies done like this