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unethical behavior by Pfizer and Parke-Davis in research

unethical behavior by Pfizer and Parke-Davis in research

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When a business intends to prove that its products or services are safe and effective, it might engage in practices that are morally unethical and professionally suspect. An example of unethical business research conduct was the case of Neurontin, a drug manufactured by Pfizer and Parke-Davis. The drug is approved for the treatment of post-herpetic neuralgia and epilepsy but it can also be used off-label for uses that FDA has not approved. These off-label uses include treating bipolar disorder, migraines and restless leg syndrome (Ramírez de Arellano, 2009).

In many instances, physicians prescribe the drug off-label for a wide range of conditions such as insomnia and hot flashes. With time, it has been found that the off-label uses have exceeded the uses that FDA has approved. In 2004, Pfizer urged physicians to give more prescriptions of the drug’s off-label uses something that is not legal. The company was interested in having more of the off-label uses approved by FDA, it went ahead to carry out research to establish if the drug also works for other conditions. If they are able to convince the federal regulation that they have enough evidence of the drug’s efficacy and safety, then FDA can extend some of off-label uses. Pfizer and Parke-Davis used some unethical strategies to offset their scuttle publications of some unfavorable findings they got (Ramírez de Arellano, 2009).

They used deceptive tactics such as delaying reports that had indicated no evidence of the efficacy of the drug. They also reinterpreted negative data and bundled negative findings together with positive studies in order to neutralize their results. They used selective outcome reporting, a practice that employed two different techniques: changing trial outcomes to produce the results they wanted and not reporting negative outcomes. Alteration of outcomes of trials so as to achieve the desired results involves the modification of the purposes of research after it has been done. Drug trials involve primary and secondary outcomes, but the primary outcomes rea more important.

In this unethical research behavior the injured parties are the patients who were deceived to think that the drug could treat some of their conditions. Patients bought the drug with the knowledge that it could cure some of their conditions which was not true. The patients ended up buying the drug but the drug was not effective in treating their conditions. Physicians who were convinced to sell the drug for other uses were also affected by the unethical behavior. They often had to deal with unsatisfied patients who bought the drug to treat their conditions. The physicians would also be reported to authorities for prescribing a drug that was not effective.

The unethical behavior by Pfizer and Parke-Davis resulted to the company being fined $430 million for criminal fines and other civil penalties (Ramírez de Arellano, 2009). The public image of the organization was also destroyed by the unethical business behavior. People no longer believed in the organization and the negative image made people stop purchasing other drugs produced by the company. The unethical behavior resulted to individuals boycotting products from the organization as they no longer trusted the organization. The unethical behavior resulted into the society having a negative impression of the company. These practice undermined the trust the society has on science and also mocked the system that comes up with evidence for making decisions (Ramírez de Arellano, 2009).

The unethical behavior could be avoided by publishing the correct results regarding the research. The organization should not have altered the results in any way but displayed the true outcome of the research. Clinical trials are the core of what people do in healthcare and hence any results should be adequately reported to avoid any problem from drug use.

References

Ramírez de Arellano, A. (2009). HEALTH AND SAFETY. Retrieved January 10, 2015, from http://www.citizen.org/Page.aspx?pid=2887

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