The Law and Ethics of the Pharmaceutical Industry


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In the patient-physician relationship, ethics is the foundation of confidence, and confidence is the foundation of sustainability. With the most evident objectives in mind, we suggest four proposals on how to deal with a potential conflicting interest when presenting a talk, publishing a paper, or planning a trial Table 1. Proposals for the declaration of interest and how to improve transparency whether a conflict of interest might exist.

The declaration of interests does not necessarily mean that the interests are in conflict with truth 3. Conversely, also a declared conflict of interest can still negatively influence science and practice In scientific journals, transparency is needed not only with regard to financial but also intellectual interests The readers and the public must have the opportunity to form their own opinions about the independence and the value of a study An unstructured and unweighted list of many sponsors, although unintentionally 24 , could make a contributor falsely appear to the public to be both prestigious and independent 3 , To be informed, not only readers and listeners but also patients need complete transparency It should be considered that the amount of financial funding by the industry must be stated for each included subject at least for the complete study in the patient information form of any investigator-initiated trial Table 1.

The disclosure is needed whether the money goes to the institution or into the pockets of the investigator. Mistrust will spread when sustainability is neglected. A damaged reputation ultimately results from growing mistrust, as has been discussed with the examples of rofecoxib or the gene therapy for ornithine transcarbamylase deficiency 3 , 4.

When publishing purely industry-driven research, the name of a highly recognized scientist can be misrepresented as an author. Ghost, guest, or gift authors might make a paper look like good science If included in the list as co-authors, however, employees or experts acting in charge of pharmaceutical companies can influence the results.

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Ethics in pharmaceutical sales

As discussed for epoetin or for some psychopharmacological trials, drug company employees could significantly guide the presentation of data 27 , Employees can publish their own papers but should not be made co-authors of investigator-initiated trials. This must be clarified by contract from the beginning of the cooperation Table 1. The contribution to a study by employees or representatives of the industry should exclusively but explicitly be mentioned in the acknowledgments Material goods such as medicinal products or medicines can best be manufactured and distributed by market mechanisms; but social and personal relations should still be regulated by moral values True science must not be free from any interest, be it economic or emancipatory In order, however, to maintain academic integrity and to comply with the fiduciary duty of the medical profession, it is in the interest of the credibility of each scientist and every physician to check for possible conflicts of interest.

Intrinsic virtue of professionals should be encouraged and affirmed 3. Physicians will be motivated to keep their own interests under better control by the need to make their interests transparent. When patients can no longer trust medicine, controllers and lawyers will dominate the scene Transparency consequently allows for more tolerant regulation because the ethical principles are proactive and not restrictive.

The positions in this article are personal opinions of the authors. National Center for Biotechnology Information , U. Journal List Croat Med J v. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Proposals With the most evident objectives in mind, we suggest four proposals on how to deal with a potential conflicting interest when presenting a talk, publishing a paper, or planning a trial Table 1.

Background

Table 1 Proposals for the declaration of interest and how to improve transparency whether a conflict of interest might exist. Open in a separate window. Proposals How to improve transparency 1. For the sake of confidence, the dominant conflict of interest should be declared first 1. Consider mentioning funding by industry also in the patient information form of any investigator-initiated trial.

Avoid employees of a company influencing the conduct of a trial and the presentation of data 27 , It should be part of the primary contract that all contributions by employees or representatives of industry can only be mentioned in the acknowledgment Declaration of Conflicts of Interest CoI The declaration of interests does not necessarily mean that the interests are in conflict with truth 3.

Authorship When publishing purely industry-driven research, the name of a highly recognized scientist can be misrepresented as an author.

M. N. G. Dukes, The Law and Ethics of the Pharmaceutical Industry - PhilPapers

Conclusion Material goods such as medicinal products or medicines can best be manufactured and distributed by market mechanisms; but social and personal relations should still be regulated by moral values Acknowledgments The positions in this article are personal opinions of the authors. Leopards in the temple: J Law Med Ethics.

Giving and receiving of gifts between pharmaceutical companies and medical specialists in Australia. Reconnecting the dots—reinterpreting industry-physician relations.

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N Engl J Med. The Vioxx pharmaceutical scandal: The financing of drug trials by pharmaceutical companies and its consequences: Does the pharmaceutical industry influence guidelines?: Influence of industry on renal guideline development. Clin J Am Soc Nephrol.


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Dec 20, Jamie rated it really liked it. Very balanced treatment in my opinion of the special position this industry has in society and the strange legal and ethical implications of its responsibilities and place. A little bit of history is included. Surprisingly easy to read, nicely typeset.


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The tone is humorous enough to keep it interesting and the author does not make the mistake of straying too far over either the line of entrenched conservative thought or uninformed liberal hand-waving, electing instead to present evidence from Very balanced treatment in my opinion of the special position this industry has in society and the strange legal and ethical implications of its responsibilities and place. The tone is humorous enough to keep it interesting and the author does not make the mistake of straying too far over either the line of entrenched conservative thought or uninformed liberal hand-waving, electing instead to present evidence from both sides of complex issues.

It will be a valuable reference to me in years to come, and I'd recommend it for anyone interested in medicine, the drug industry, intellectual property law, or a modern view on society's expectations for accessibility of medicines. Sanaz marked it as to-read Feb 06, Tomas Blazek added it Feb 09, Inez marked it as to-read Nov 30, Precious Grace marked it as to-read Feb 08, Iman Zein marked it as to-read Jan 16, RealDeadpool,The marked it as to-read Apr 21, Libby Nusz marked it as to-read Mar 20, There are no discussion topics on this book yet.

The Law and Ethics of the Pharmaceutical Industry

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