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Business Research Ethics

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Business Research Ethics

Neurontin which is a medication that is manufactured by Pfizer and Park-Davis, wanted to convey that their product was safe and effective. Pharmaceutical companies can be suspicious and considered unethical practices. The drug Neurontin was "approved to treat epilepsy and post-herpetic neuralgia but may also be used off-label, i.e., for uses not approved by the Food and Drug Administration (FDA). The latter include the treatment of migraines, bipolar disorder, and restless leg syndrome" (2009, December Annette B. Ramírez de Arellano, DrPH) It was found that Pfizer had been urging doctors to prescribe this medication for off- label uses, which is illegal. Because if this Pfizer had to pay $430 million in criminal fines and civilian penalties" (2009, December Annette B. Ramírez de Arellano, DrPH). The legal case against the drug manufacture, they had found that the company tried to skew the research data they conducted on the medication to avoid more repercussions from the food and Drug Administration from the unfavorable finding on the medication, "legitimate researchers saw their findings rewritten and recast to, in the words of one of company's medical writer, "make [the overall picture] sound better than it looks on the graphs (2009, December Annette B. Ramírez de Arellano, DrPH)." It was also found that research had been skewed to to support only the desired findings.

Because the company skewed their research, and did not disclose all the finding from the clinical trials the public that was prescribed this medication were the injured parties. Doctor had been prescribing this medication for ailments not specified for the medication. To quote The Guardian: "Our failure to ensure full, undistorted publication of all trial data is the single most important issue in medicine today, because this is the only way we can know whether a treatment does good, or harm." The unethical behavior has placed emphasis that drug companies try to cover up true finding just to make a profit. Pfizer is a large pharmaceutical company and these fabrications cause the company to lose some of their credibility. It affects the pharmaceutical industry because consumers and enforcement agencies are forced to take a closer look at the drug information to protect the public from harm, or death. Our society has become more concerning about the medications that are being made for us, and doctors are beginning to be questioned more and more on their treatment plans because of it.

There is such a large competitive market with the big pharmaceutical companies, that we have begun seeing clinical trial information be skewed or hidden from the companies reports. While it is also illegal for the pharmaceutical companies to give physicians incentives to prescribe a particular drug to their patients, so the pharmaceutical company gains a larger profit and offers kick back to doctors. By doctors accepting this arrangement, the medical industry is losing its credibility. Patients do not receive the same type of care as they used to from their physicians, and it is know that doctors are over prescribing their patients. If the pharmaceutical companies went back to doing things in a more ethical manor, and reporting all research and findings, the consumer and doctors could make a better educated decision on what route would be the best treatment vs. having the pharmaceutical company push a product to gain a profit.

The Case of Neurontin: Skewed Research in the Service of Selling

December 2009

Annette B. Ramírez de Arellano, DrPH

When pharmaceuticals are intent on proving that one of their products is safe and effective, they may engage in practices that are professionally suspect and morally unethical. The recent news on Neurontin is a case in point.

Neurontin, manufactured by Pfizer and Parke-Davis, is the brand name for the drug gabapentin. It is approved to treat epilepsy and post-herpetic neuralgia but may also be used off-label, i.e., for uses not approved by the Food and Drug Administration (FDA). The latter include the treatment of migraines, bipolar disorder, and restless leg syndrome.

In addition, some physicians prescribe Neurontin off-label for a wider range of higher-prevalence conditions, including hot flashes, insomnia, and certain types of tinnitus (ringing in the ears). Over time, off-label uses have exceeded approved uses, so they are an increasingly important share of the market. In 2004, sales of the drug peaked at $2.7 billion. But that same year Pfizer was found to be urging physicians to prescribe Neurontin for off-label uses, which is illegal. As a result, the company had to pay $430 million in criminal fines and civilian penalties. But this was not the end of the Neurontin saga.

Because companies have a vested interest in having the FDA approve some



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