In today’s society we have found that the best way to find what works for individuals and businesses alike is done through business research. This is not always done in ethical manners though. Some companies tend to ask questions that are inappropriate while others changed the information they have been given to make their product look more appealing. This paper will focus on skewing the research results in the service of selling the drug Neurontin.
Neurontin is a brand name for the drug gabapentin and it is manufactured by Pfizer and Parke-Davis (Ramirez de Arellano, 2009).
The drug has been approved by the FDA to use in treating neurological conditions such as epilepsy. There have been a large number of off-label uses added to the list that have not been approved by the FDA which has increased the company’s sales.
In 2004, Pfizer was found guilty in urging physicians to prescribe Neurontin to patients for off-label uses such as treatment of migraines, bipolar disorder, insomnia, and hot-flashes (Ramirez de Arellano, 2009).
This act was an illegal one that cost the company millions of dollars in fines and penalties. That was not the last of the case on Neurontin.
Since so many people had used Neurontin for various treatments not approved by the FDA, a large number of companies decided to show an interest in getting some of the off-label uses approved. In order to do this the companies began conducting research to see if the drug really worked for the ailments. If it did indeed work, it could be approved through the FDA. This would in turn help the company make more money selling Neurontin.
The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has ...
After the legal case was started in 2004 it opened another door that provided information showing strategies that Pfizer and Parke-Davis used to offset the publication of unfavorable findings. In 2008 reports were released to the public that showed Pfizer and Parke-Davis had delayed reports if no evidence was found in the efficacy of the drug, reinterpreting negative data, and fusing negative data with positive studies to cancel the results, and some researchers saw their work being rewritten by the company’s own medical write to make it sound better than the graph showed it (Ramirez de Arellano, 2009).
During the studies done on Neurontin 20 clinical trials were identified and only 12 of those reported in publications, in which 8 of those published trials had different primary outcomes reported than was in the original research protocol (Ramirez de Arellano, 2009).
These differences included changing the primary outcome, not distinguishing between the primary and the secondary outcomes, and not reporting all of the primary outcomes. There was 21 primary outcomes for the research and out of those 21 protocols there was 6 not reported and 4 were put as secondary outcomes instead of primary. The changes made in the published reports were done to make Neurontin look favorable for the unapproved indications.
In the Neurontin situation of skewing the research done for the medication, affects the people that use the drug along with others that take any medication. It makes the doctors look as if they do not know what they are doing when they prescribe the medication and leaves individuals in an untrusting state to try something new to treat their ailments. It also makes the scientists that develop the drug look bad. Another thing this does is undermines individuals’ trust in published studies and the entire decision-making process.
The organization is affected by this unethical behavior in many ways as well. First off the company was faced with a hefty criminal fine for coaxing the doctors to prescribe the drug to the public for off-label purposes. Secondly the company lost accreditation with the public for skewing the research being done to make the drug more appealing in what it could treat. Skewing the research affected society by losing the trust of individuals when it was made public that the research published had been tainted. It is hard to trust again when you find out the information you are being give is all but the truth.
INTRODUCTION The assignment will explore ERP from its origin and would shed light on its fundamentals and implementation procedures. ERP will be evaluated from two perspectives of two different companies which implemented the ERP solution. First we will be discussing! SS Cisco! |s!" ERP implementation and the technical and business issues related to that and then we will move on to the other case ...
Unethical business research could be avoided if companies that do business research would publish all of the truth without changing any of it or doctoring it up to look better than it really is. If the punishment for using unethical business research were harsher it may deter companies from using unethical practices to conduct their business research. Companies that continue to be found guilty of using unethical business research should be humiliated to the point nobody would want to do business with them, forcing them to close their doors.
In conclusion it can be noted that the most important part of finding the right treatments today in medicine is through clinical research data and that data has to be 100% undistorted to know whether or not the treatment is one that will do good or one that will do harm. This goes for any type of business research and should be followed with all companies.