There are many issues involved with the relationship between physicians and the pharmaceutical industry. According to David Goldbloom, he proposed that gifts that the pharmaceutical industry wanted to give physicians should not be gifts, but instead should be materials that are sold to the physician at cost. This not only would avoid the appearance of impropriety, but would lower the overall cost of the drug to consumers. This position was picked up by the American Medical Students Association, who stated that there should be a complete ban on industry involvement in education.
2) Ethical and policy issues in research involving human participants. When a pharmaceutical company decides that they are going to conduct a human clinical trial, there are issues of the morality and ethics of conducting clinical trials. One of the first things is that the research subject must have full informed consent about the topic and the implications of the research that they are going to be involved in. Second, the government has in place in protecting the clinical research subject to assure that they are treated in an ethical way and are not subject to abuse or maltreatment in the clinical research process.
In these regulations, the physical and emotional effects on the subject are minimized, additionally, the psychological and physical effects are reasonable, given the medical subject matter involved. Finally, all research involving human subjects must be analyzed and approved by the FDA in order to assure that the FDA’s guidelines are being met and that the research is indeed safe for human subjects. 3) Research involving persons with mental disorders that may affect decision-making capacity.
Many of the same ethical considerations that involve research on human participants also apply to research trials on participants with mental disorders that may affect their decision making capacity. The only additional consideration is that there is an advocate for the person that should be in a position to assure that the medical and mental issues of the participant is indeed taken care of. Pharmaceutical companies should assure that all ethical guidelines and laws are followed to assure that those individuals with mental disorders are not taken advantage of in the clinical research process.
4) Bias in pharmaceutical sponsored (funded) clinical trials. There is a natural bias inherent in a pharmaceutical company conducting the clinical research on a drug. First, the pharmaceutical company has invested years and millions of dollars in developing and refining a drug. If that drug is not approved, they are out all that time and money. The individuals that work for the company and that are conducting the testing may feel pressured to manipulate the results to come out a certain way to assure that the company does not lose the money and time they have invested in the drug development process.
5) Relationship between clinical investigators and the pharmaceutical industry. When clinical investigators are investigating the efficacy of a drug, they should avoid the appearance of impropriety by working to maintain their independence. The investigator should not have any relationship with the industry in which they work. This helps them to maintain their independence and they are better able to accomplish their job in an efficient and professional manner. Investigators should also avoid paid consultancies as they give the appearance of a conflict of interest.
Investigators are there to investigate the efficacy of the drug in question, and they should be left to do their job without being pressured to achieve a certain result for the pharmaceutical company. 6) Corporate hand in clinical trials and their contracts with academia. The corporate hand in academia should be one that is very light. There should be a full disclosure of all fiduciary obligations that academia has with the corporate world, and it should be up to an independent panel to determine if that financial relationship is affecting the academic independence of the researcher.
Contracts with academia should be ones that do not have any implicit or explicit strings attached, and should not be contingent on a certain performance level. Works Cited (1999, March 11). Research Involving Individuals with Questionable Capacity to Consent: . Retrieved June 20, 2009, from U. S. Department of Health and Human Services Web site: http://grants. nih. gov/grants/policy/questionablecapacity. htm Bero, L. (2003, June 11). Corporate and Economic Pressures on Academic Freedom. Retrieved
June 20, 2009, from University of California Web site: http://www. universityofcalifornia. edu/senate/committees/ucaf/afforum/bero. pdf Chopra, S. (2003, July 2). Industry Funding of Clinical Trials: Benefit or Bias?. Retrieved June 20, 2009, from www. jama. ama-assn. org Web site: http://jama. ama-assn. org/cgi/reprint/290/1/113. pdf Goldbloom, D. S. Physicians and the Pharmaceutical Industry . Retrieved June 20, 2009, from Canadian Psychiatric Association Web site: http://ww1. cpa- apc.
org:8080/publications/archives/bulletin/2003/october/editorialEn. asp Kapp, M. B. (2006). Ethical and legal issues in research involving human subjects: do you want a piece of me?. Retrieved June 20, 2009, from Journal of Clinical Pathology Web site: http://jcp. bmjjournals. com/cgi/content/full/59/4/335 Panacek, E Guidelines for Clinical Investigator Involvement in Industry-sponsored Clinical Trials. Retrieved June 20, 2009, from www. saem. org Web site: http://www. saem. org/download/edward. pdf
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