Business Research Ethics
“Ethics are norms or standards of behavior that guide moral and choices about our behavior and our relationship with others” (Cooper & Schindler, 2011, p.). When a business conducts a research, the business uses ethics to guarantee that no individual will be hurt or suffers from the consequences from the research. When a business is planning a research, some of the ethics a business must consider are to: protect the rights of the individual, follow the ethical standards, and to ensure that the information that is acquire is ethical. The purpose of the research is not to allow any type of physical harm, discomfort, pain, embarrassment, and the loss of privacy (Cooper & Schindler, 2011). According to “Copper & Schindler” (2011), “Many corporations, professional associations, and universities have a code of ethics.” Ethics are an important part for a business and researcher when conducting a research, but sometimes ethics are violated. Some of the ways a business or a researcher may violate the ethical standards are by violating an individual’s confidentiality, and changing data, or creating false data. Unethical research behavior does not only affects the business but can also have an effect the individual(s) participating in the research.
Pfizer and Parke-Davis who are a pharmaceutical companies and Dr. Potti who studies cancer and works at Duke University are an example of how organizations can be part of an unethical behavior. Because of their unethical behavior not only their organization suffers but also the participants may be affected by it.
The purpose of the pharmaceutical companies is to develop safe drugs and use them to treat ongoing diseases and new ones. With the use of these drugs many people will be able to treat their disease to have a healthier lifestyle. With the demand of new drugs to cure or treat new diseases, many pharmaceutical companies may violate their code of ethics, and make money their first priority instead of finding a cure for a disease.
One way pharmaceutical companies can violate their code of ethics is by skewing the information about their drugs. In the case of Neurontin, manufactured by Pfizer and Parke-Davis Neurontin is the brand name of the gabapentin drug (Ramirez de Arellano, 2009). The Food and Drug Administration (FDA) approves Neurontin to treat people who have epilepsy and post-herpetic neuralgia. Besides treating epilepsy and post-herpetic neuralgia, Neurontin also can be use for off-label uses to treat some diseases that the FDA does not approve like migraines, restless leg syndrome, and bipolar disorder. Also, some physicians would prescribe Neurontin for off-label uses to people who suffered from insomnia and hot flashes.
With time, the sales of Neurontin for off-label uses increased to $2.7 billion in 2004. The increased of the sales were because of physicians prescribing Neurontin for off-label uses for their patients. Pfizer was urging physicians to prescribe Neurontin for off-label uses that were considered illegal, and Pfizer was fined $430 million in criminal fines and civilian penalties. The Food and Drug Administration do not approve the uses of off-label uses, and pharmaceutical companies like Pfizer want to have the approval of these off-label uses. With the approval from the FDA, Pfizer will be able to broaden the drug’s market, but without the approval promoting or advertising off-label uses is prohibited (Ramirez de Arellano, 2009). In addition with the approval of the FDA pharmaceutical companies will be able to publish their studies that claimed the benefits of their drugs.
When pharmaceutical are determined to prove that their products are safe and effective, sometimes they become part of unethical practices. Some pharmaceutical companies are willing to manipulate their own trial data to manufacture good results to make their ineffective and unsafe drug seem safe and effective (Benson, 2010). A recent report from BCC, the report explains that in some countries pharmaceutical companies are not required to submit their entire safety data in their journals when submitting it. Without requiring drug companies to publish all of their safety data, these companies can submit information that only provides only what seems to be positive data and hide the negative data. “Pharmaceutical companies can manipulate their own trial data to manufacture good results” (Benson, 2010).
In a legal case against Neurontin, Pfizer and Parke-Davis used some strategies to cover up some unfavorable findings from their research. When their strategies were uncovered in 2008, Pfizer and Parke-Davis detained reports where it proved that there was no evidence of the drug’s efficacy, their negative data was reinterpreted, and the grouping of negative and positive studies to counterbalance the results. According to “Ramirez de Arellano” (2009), “In some cases, legitimate researchers saw their findings rewritten and recast to, in the words of one of company’s medical writer, to make [the overall picture] sound better than it looks on the graphs.” Pfizer and Parke-Davis were skewing information on off-label uses of Neurontin. They manipulated their data to support their findings, and failed to report any negative outcome from their findings. When pharmaceutical companies skew or manipulate their findings on a drug, people who take Neurontin for off-label uses are endangering their lives. The FDA does not approve Neurontin for off-label uses because Pfizer and Parke-Davis cannot prove the efficacy of the drug and that it is safe for the patient.
Because of the unethical practices committed by Pfizer and Parke-Davis people may start to lose the trust they have on science and the studies that have been published.
To avoid unethical behavior, pharmaceutical companies must document their outcomes when modifying their findings. All of the changes in a research must be documented and be included in the reports that have been published on the clinical trials. “In the U.S., drug companies are supposed to publish all trial data, but it is not a requirement in the U.K. Though many in the U.K. are working to make it a requirement, drug companies will likely continue to manipulate that trial data either way” (Ramirez de Arellano, 2009).
“Dr. Potti became the face of the future of cancer treatment at Duke University, offering patients a better chance even with advanced disease” ("Cbs News", 2012). People who have cancer go through chemotherapy, and it can be tough, debilitating, and dangerous for them. Dr. Potti worked in an experimental treatment where patient’s genetic makeup is matched to chemotherapy. When Dr. Potti was behind of this experiment other scientist verified the results of this experiment and found many problems and errors in it. In an investigation, CBS News reveals that the treatment for cancer that was developed at Duke University was a failure and a fraud.
At Duke University, there was an announcement that they had discovered how to match a patient’s tumor to the best chemotherapy drug ("Cbs News", 2012). Every person’s DNA is distinctive, so every tumor must be different and what may work for one patient may not work in another. People who have cancer see this experiment as hope, and may be their last resort.
According to "Cbs News" (2012), "In 2010, we learned that the new method was a failure. But what isn't widely known, until tonight, is that the discovery wasn't just a failure, it may end up being one of the biggest medical research frauds ever - one that deceived dying patients, the best medical journals and a great university.” Dr. Potti was committed to fight and find a cure for cancer; he was part of a commercial for Duke University that claimed where there have made a discovery that will change how people view medicine.
Dr. Potti was born in India, he was known as a modest and a hard worker. In 2003, he first did research at the University of North Dakota and than in Duke University. Potti’s goal was to tell a cancer patient that he is there to treat his or her particular cancer. Dr. Potti worked in the lab of Dr. Joseph Nevins, and in this lab he decoded the genetic makeup of hundreds of tumors. In the research, there were created huge computer files of data from the hundreds of tumors that were decoded. With this discovery many doctors wanted to started using this discover to save lives, but Kevin Coombes and Keith Baggerly from MD Anderson Cancer Center in Houston decided to analyze the data to verify the results of this experiment. As Keith Baggerly started to process the results, him and Kevin Coombes noticed that something was odd and could not explain it.
Coombes and Baggerly are experts in the type of data that Dr. Potti’s created in his research. They both email their questions to Dr. Potti and Duke University stating that they were a few clerical errors, but Dr. Potti informed them that his new work confirmed his results to be right. Drs. Nevins and Potti started a company where patients can enroll in the clinical trial so that their tumors could be surgically biopsied to be matched with the best drug, but at MD Anderson, during months of analysis, Baggerly and Coombes kept finding errors that they thought were alarming. ("Cbs News", 2012). When Baggerly and Coombes analyzed this experiment they kept finding errors after and error, this led them to suspect that Dr. Potti reversed some of the data. If Potti reversed some of the data this could mean that some Potti’s patients could have gotten not the best but the worst drug for their tumor. If patients are receiving the wrong drugs this can harm them. With this information, Baggerly and Coombes concluded that this discovery is worthless.
Dr. Nevins thought that him and Dr. Potti addressed the issues that were brought up to them, but other researchers at the National Cancer Institute also had trouble with the data. With all of the researchers doubting Dr. Potti’s work, Duke Univeristy suspended the enrollment of new patients, but after reviewing the analysis of the experiment that an outside committee conducted Duke University reopened the enrollment because the Dr. Potti was right about his work. Within time, Dr. Nevins discovered that Dr. Potti changed the data that was under investigation because it did not approve this theory. With the discovery of the data being changed, Dr. Nevis only explanation for this was that data was manipulated. Patients who enrolled in the clinical trial were told that there was an 80% chance that exactly drug for their tumor would be found, and it was not true.
Juliet Jacobs was a patient of Dr. Potti and was told that the chance of her receiving the right drug was approximately 80%. Walter Jacobs, Juliet’s husband asked Dr. Potti why was the clinical trial suspended, but Dr. Potti ensure them that this experiment was going to help her. Juliet Jacobs had Stage IV lung cancer, and she saw this clinical trial as her last chance. For Juliet, Dr. Potti’s research promised her the right drug for her right now. Unfortunately, Juliet Jacobs died three months after she enrolled in the clinical trials.
Because of Dr. Potti’s unethical behavior, he resigned from Duke University and was investigated for misconduct in his research. According to "Cbs News" (2012), "Dr. Potti’s; my primary concern at all times is and will be the care of patients and seeking new ways to treat cancer." To avoid an unethical behavior like this to happen again is to implement new procedures, and not to oversee an experiment when other experts in the field have many questions and doubts about the experiment or research.
When conducting a business research it is important always to go by the standards of ethics. Ethics are meant to protect the organizations conducting a research, and the individuals participating in the research from unethical behaviors. Sometimes unethical behavior may not be able to be prevented or avoided, but by punishing individuals who have committed any unethical behavior will prove that when violating the code of ethics there will be consequences.