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Whistleblower is a person passes information on violation of laws that are a direct threat to public interest such as health and safety by applying ethical principles in the growing obstacles in the organization. Based on this, it is clear that Laraoche was not a whistleblower; he was someone who did his work as expected by his profession. His suggestion to the management of Perck Pharmaceutical based on the side effects of the new drug were informed by his professional orientation. His timely interjection was because he had not performed enough trials to allow the drug to go for Food and Drug Administration (FDA) approval. This he did to avert the possible destruction of the patients' health without the fear of retaliation or losing his job.
Laraoche was apprehensive due to the side effects observed in the initial trials. Of the more than 11,000 patients of ages 18 to 90 given the sample drug during the clinical trials, a tenth of one percent reported some side effects including mood swings, depressions, and suicidal thoughts. Laraoche was undecided but he wanted further research carried out before the drug could be administered safely and effectively to the patients. In addition, Laraoche did not agree with the Perck pharmaceutical corporation on the timing for application to the Food and Drugs Administration. He advised that the approval of the drug would be detrimental to patients due to the associated side effects; a call the corporation ignored proceeding with the FDA application based on the trials data.
Laraoche's objection was because the firm did not value his opinion. He was called to the meeting by the marketing team to give his expert opinion on the safety of the drug where he expressed reservations in pushing the drug into the market citing misgivings. The marketing team went ahead to seek FDA approval based on insufficient trial data. He was instructed by Smith to revise the application to the FDA for approval and he refused. In his email to Smith, he expressed his distaste with the fact that a lawyer who, in his opinion knew nothing about drug research overruled his suggestion as a trained Doctor. According to him, this was a professional as well as a personal insult.
Nonetheless, Laraoche was also appalled by the fact that his authority was undermined. He was being used as a rubber stamp authority to approve the FDA application without following the required procedure. As the Director of Medical Research, his main responsibility was to take charge of the development of the drug. It was in order for the Marketing team to seek and uphold his expert opinion as well as have him complete the necessary procedure for the approval of the drug by the FDA. Instead, they made Amy Lateef, the associate director of medical research to sign the application on behalf of Laraoche. Laraoche expressed his disappointment in Smith for undermining the integrity of Perck Pharmaceutical's administrative structure, which requires him as the Director of Medical Research to have the final sign off on all the FDA applications.
As much as Laraoche disapproved the FDA application at that time, he noted in the application that 10% of the one percent of patients experienced side effects from the drug. He went ahead to recommend that the warning label contain information on mood change, anxiety and depression. Smith disregarded this content and instructed Laraoche to revise the contents of the application. The final application made no reference to details of the statistics, instead read "due to statistically insignificant amount of patients" and it did not put emphasis on the side effects as Smith thought the information was not important so he advised against the warning on labeling. The application was falsified to read that expert opinion thought it was not necessary for the label address mood change, anxiety and depression. Laraoche therefore objected to the signing of the application based on the language Smith was suggesting.
Comparison and Contrast to the Pierce Case Law
Doctor Grace Pierce verses Ortheo pharmaceuticals case is similar and different in certain respects to George Laraoche verses Perck pharmaceuticals.
First, Pierce and Laraoche both held the same positions in their respective organizations. They were in charge of research and specifically pharmaceutical drug research. They were both Directors of Medical Research in their respective companies with vast experience spanning more than ten years. With ten-year of experience at Perck Pharmaceutical Laraoche was promoted to oversee the development and research of the therapeutic drugs, an allergy and asthma drug. Pierce on the other hand was also the medical director in Ortheo Pharmaceutical; her responsibilities were to establish procedures for the testing and safety of the manufactured drugs in addition to looking into the development of therapeutic drugs within the corporation.
Second, both Pierce and Laraoche expressed corncern on the safty of the drugs they were developing. They claimed that they were harmful to the patients. In Laraoche's case, the drug had shown certain side effects in the first trial and he wanted more tests done. Some patients during the trials phase, had mood swings, depressions, and suicidal thoughts; this number was a tenth of one percent of the patients. Half of Laraoche's research team wanted to conduct further trials to get conclusive results on the drug and Laraoche agreed. On the other hand, Doctor Pierce was worried due to the saccharin content in the loperamide, she stated that saccharin in lorpaermide was harmful to children and the elderly and was to be avoided or an alternative drug made available to them.
Third, both the Pharmaceutical Corporations applied for FDA approvals even after their Directors of Medical Research had objected to the action. These decisions were made by the respective marketing divisions within the companies to approve the sale of the drugs. Both Pierce and Laraoche expressed caution in the approvals because the drugs had the potential of causing griveous bodily harm to the consumers. Their disagreements to the certifications resulted in both of them losing their positions.
Fourth, Laraoche and Pierce insisted on further research on the drugs they were developing and recommened some adjustments before introduction them to the markets. The team working with Pierce agreed that despite the consistency in concentration with the Lopermid marketed in Europe, they had to adjust their version to suit the United States standards.
Laraoche too insisted on further trials of the drug expressing misgivings at the meeting with the marketing team.
As the director of medical research in Ortheo Pharmaceutical Corporation, Grace Pierce never signed any legal agreement to cement her contract; instead, she signed a secret agreement making her employment vulnerable in regard to "employee at will." As the law stipulates, lack of an employment contract allows the employer to terminate the employment with or without any cause so she decided to resign from the firm. George Laraoche on the other hand, did not resign but was terminated for unprofessional conduct and violation of Perck's Pharmaceutical policy of harassment by claiming the team was "selling out to the marketing sons of bitches."
In Laraoche's case, the drug they were researching on was given to more than 11,000 patients during the clinical trials of between the ages of 18 to 90 to monitor its side effects and establish other relevant information that could allow the drug to be administered safely. During the trial phase, they noticed that some patients had mood swings, depressions and suicidal thoughts and a tenth of one percent of the patients developed some degree of side effects. In contrast, Doctor Pierce's opposition to the manufacturing of loperamide at Ortheo Pharmaceutical was not based on her personal research, but on information from Europe that indicated that, saccharin concentration in loperamide sold in Europe, was not suitable for usage in the United States. In her opinion, she concluded that saccharin was not safe at all and opposed it in the United States market.
Doctor Pierce ended her involvement in the development of loperamide but let the rest of the team continue with the project. Though she knew that the Investigational New Drug application (IND) would have to be approved by the FDA before any clinical trials were carried out, she continued opposing the development of loperamide at Ortheo Pharmaceuticals. She sent a message to the team expressing her disagreement with their decision to continue making the drug due to the harmful effects of saccharin formulation in the drug. Laraoche never opposed the team during the research of the drug but was opposed to the sale before sufficient trial. He called for further detailed and conclusive research to focus on the side effects before the drug could be introduced into the market.
According to Putrus, it is necessary that personel in an organization adhere to the established signature authorization policy at all times. Authorization policy helps in establishing accontabilty as well as strengthening of the organizations internal control policy. In the case of Perck Pharmaceutical, the weakened internal control is evident in the…[continue]
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