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Business Research Week 2

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Submitted By lilbitac
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In 2001 pharmaceutical giant Pfizer was slapped with a lawsuit for the misconduct of tovafloxacin’s clinical-trial in 1996. Trovan is an oral antibiotic .Thirty families filed the lawsuit stating the unethical treatment of Nigerian children. The suit also mentions how Pfizer did not obtain consent from the children’s parents, as well as failure to adhere to the study protocol resulted in brain damage, hearing loss, and death of eleven of the 2,000 children in the study. The suit also claims that Pfizer’s irresponsibility was caused by taking advantage of a meningitis epidemic. Pfizer also failed to give the families the option of seeking an “effective and approved alternative” treatment. The suit requested that Pfizer provide ongoing medical care to evaluate the liver and joint function of the enrolled children (Ready, 2001). The uproar came to a head when stories came out in the Washington Post December of 2000. China, Africa, Coat Rica, and Thailand were all mentioned in the Washington Post about how US researchers were not ensuring that overseas study subjects gave informed consent (Ready, 2001). Pfizer shot back by stating all studies were “designed and conducted in accordance with good medical practice and ethical norms and denies the families were unaware that their children were part of the study” (Ready, 2001). Pfizer fessed up to some “protocol deviations” and “record keeping errors”, but most importantly did not “compromise patient care or the scientific conclusions of the trial” (Ready, 2001). Trovan was approved in 1997, but not for children. In 1998 sales were $160 million, but in 1999 the product was taken off the market in Europe for causing liver problems.
The unethical research behavior established is the failure to get participants informed consent. Securing this form of consent is a matter of fully disclosing the procedures of the research designed before requesting permission to proceed with the study. If children are involved then the researcher needs to get the parents’ consent or the legal guardian of the child. Parents are often interviewed during the selection process to ensure that if their child is chosen, he or she is mature enough to handle the activities planned and has the verbal and physical capabilities necessary (Cooper & Schindler, 2011). If the parents of those children had known some of the side effects would cause death, it is doubtful that anyone would have signed their children up for the trial, which is why it is possible the consent never existed. The injured parties involved are the children who have died or have suffered from permanent damage. Pfizer is also an injured party because there is a reputation at stake. As a well-known pharmaceutical company it’s not good to have preceding lawsuits that have caused deaths. The company could lose money for paying out the lawsuit, but also investors, clients, and customers who have bought the brand will be discouraged to do future business. This unethical behavior affects the lives of the Nigerian women who have lost their children as well the children who are left with permanent damage. These women will never see their kids again because of personal gain. This type of unethical behavior makes it harder for legitimate trial experiments to take place. Society will see trial studies as a death wish, and not as a possible cure to a diagnosis. Patients will not be as willing to volunteer.…...

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