Pharmaceutical Company Flashcards
What are the risks and benefits of pharmaceutical industry ‘support’ for research in general and more specifically for the registrar’s project?
.the candidate should discuss how industry can be kept at arms length by introducing for instance an independent board to determine suitability of research projects. The projects should also be broader than the immediate aims of the sponsoring industry. With respect to the specifics of the study to be conducted by the registrar the candidate should note that the SSRI is one of several in its class and that there should be good reasons as to why this particular antidepressant has been chosen especially if it is the one manufactured by the sponsoring company. Note that overlap would not necessarily preclude the study but the rationale has to be scientifically based.
The candidate should also note that study is likely to be limited to being illustrative and descriptive by virtue of its uncontrolled and open design. The candidate should be able to explain the importance of blinding in a study, the potential role and use of including a placebo and the statistical reasoning for randomization. However, an open study is perfectly feasible and appropriate if examining a new agent or new application if simply wanting to explore simple outcomes, and tolerability. keeping patient welfare a priority by for example considering the role of ethics committees in research, consumer advice about accepting money for teaching, and reporting all effective interventions and outcomes in patients you see with depression (and not just those of interest to the drug company).commenting on the possible limitations and advantages of the design of the proposed research. Aware of the role of pharmaceutical companies in influencing national and global research priorities. discussing the pros and cons of drug company involvement in research for example large scale studies are difficult to do without drug company involvement, registrar may have opportunities they may not otherwise get, drug companies may be interested in “me too” drugs, drugs companies first priority is to their shareholders, registrar may be influenced to prescribe drug companies product.
Having agreed to see the pharmaceutical representative, what issues would you consider as regards accepting support for your regular teaching sessions to registrars?
.the candidate must underscore the fact that registrars are generally more naïve than consultants and that they are likely to be more impressionable. It is therefore important that any support is not mixed with any marketing messages and that teaching in terms of topic content and context is totally independent of the industry. The candidate may wish to suggest better alternatives such as providing financial support to registrars to attend a national conference (not organised by the company) or purchasing equipment such as books, DVDs (again noting that these are independent and not directly promoting their product). discusses pros and cons of drug company involvement in sponsoring registrar teaching. Benefits may involve financing items, which may not be otherwise affordable such as books and computers, disadvantages may be emphasising drug interventions at the expense of non-pharmacological treatments, disseminating information that is biased. discusses pros and cons of drug company involvement in sponsoring registrar teaching. Benefits may involve financing items, which may not be otherwise affordable such as books and computers, disadvantages may be emphasising drug interventions at the expense of non-pharmacological treatments, disseminating information that is biased.
You have agreed to a speaker engagement for a fee to local GP’s on managing depression and are keen to pursue this. How would you negotiate your involvement?
.the candidate needs to demonstrate independence of opinion and be able to negotiate his/her terms. The candidate should acknowledge the importance of providing information and the benefits of medical meetings. However, it is important to note that medical involvement adds/brings credibility and this should not be compromised. Specifically, the candidate should maintain complete control of content, badging of slides and written material. Candidates should make clear to the industry what they intend to say and what they will not say. Equally, the topic of endorsement needs to be addressed. It is important both for the industry and the speaker to acknowledge that the aim is to educate and not centre around a particular topic. If resolution cannot be achieved, then the candidate must be prepared to pull out.
