12 : pharmaceutical industry and health Flashcards
conflict of interest
occur when an aspect of our private life influences or conflicts with the decision we make on behalf of UBC, or appears to do so
UBC conflict of interest policy protects our ability to deliver research and education without bias or personal interest
why COI are a problem
1) they compromise an actor’s loyalty to her mission or the parties they are supposed to serve
2) they compromise the actor’s independent judgment
“no individual can judge his or her own case because that would mix two incompatible roles, playing both the participant and the judge “
pharmaceutical conflict of interest
involves a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest
common pharmaceutical conflicts of interest
doctors recommending/ prescribing products for which they receive money from the company (note : kickbags are illegal)
-should they be required to disclose?
another pharm COI
advocacy groups that speak on behalf of patients receive funding from pharmaceutical companies
another pharm COI
pharmaceutical regulators that have previously worked in the pharmaceutical industry, and vice versa
also
industry-funded studies
opioid industry conflicts of interest
industry-friendly regulators
gifts and meals
key opinion leaders
funded politicians
marketing posed as marketing
sponsored journals
solutions
public prioritization of research agendas and funding
recognize industry funding and conflicts of interest as a source of bias
transparency in data - publish protocols/failed experiments etc.
Improve funding and COI disclosures
minimum time bw regulator and industry
why is pharma important
two thirds of canadian adults take a prescribed medication in any given year
about one fifth (21%) of canadians reported not having insurance to cover any of the cost of prescription medications in the past 12 months
percentages of canada reporting not having prescription insurance to cover medication cost was higher among immigrants (29%) relative to non-immigrants (17%) and among racialized persons (29%) relative to non-racialized and non-indigenous persons (17%)
lexchin : four main areas of interaction between industry and state ***
- user fees
- postmarketing surveillance
- transparency
- regulation of promotional activities
user fees**
when companies apply to have a new drug approved they must pay a fee to health canada. those fees form part of the revenue that is used to operate the part of Health Canada that deals with medications
user fees**
health canada, is (largely) the sole regulator of drug safety, quality, and efficacy
Yet unable to conduct the trials required to establish these factors of a drug
thus they operate under a system known as “clientele pluralism” in which industry take on a number of important roles in the process ->
As a result, user fees are increasingly important
post marketing surveillance**
all of the activities that are undertaken to monitor the safety and effectiveness of drugs once they have been approved for marketing
post marketing surveillance**
health canada can order withdrawal of any medication, yet virtually never does (prefers a negotiation approach)
Post market concerns - Vioxx and Baycol, two of the most heavily promoted drugs in canadian history were subsequently removed from market due to safety concerns
Health canada is not permitted to require manufacturers to undertake new studies into a products safety once it is on the market (only allowed to request it)
experience in the united states indicates that companies follow through on less than 1/3rd of voluntary post marketing commitments
regulatory transparency**
how much input the public and healthcare practitioners have in the decision to approve a new drug and how much public access there is to the clinical information that companies have to submit to health canada when they get the drug approved
