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What unethical research behavior was involved?
GlaxoSmithKline (GSK), which is one of the top vaccine manufacturers, was forced to pay $3 billion for bribing doctors, which allowed them to fake research. The $3 billion is intended to pay for the civil and criminal liability that arose from the unlawful promotion of prescription drugs. The company plead guilty to three counts of criminal information, which includes two counts for introducing misbranded drugs. The drugs included Paxil and Wllbutrin. They were distributed to interstate commerce. Also, there was one count for not reporting the safety data about a drug called Avandia to the Food and Drug Administration (FDA).
The company was supposed to complete in its application to the FDA the intended use of the drug. After a drug is approved, the company should have limited the promotional materials of the drug to the approved uses as outlined by the FDA, which the company did not do. The product was misbranded because its promotion was not limited to the uses that were approved by the FDA. The company unlawfully promoted the drug Paxil for the treatment of depression in patients who were under 18 years old. The FDA, however, had not approved the drug’s use for pediatric use. The company sponsored dinner programs, lunch programs, spa programs, and various other activities that were designed to promote Paxil in adolescents and children. GSK paid for the speaker to talk to an audience that consisted of doctors, and they paid for the spa or meals for the doctors that attended. The company eventually admitted that labeling was false and mislead people in relation to using the drug in patients younger than 18.
With the Wellbutrin drug, the company was convicted of promoting the product for weight loss, but it was only approved for Major Depressive Disorder at the time. The firm also promoted the drug for sexual dysfunction, Attention Deficit Hyperactivity Disorder, and substance addictions. Furthermore, the firm paid millions of dollars to doctors so that they would speak at and attend meetings, and sometimes these would be at lavish resorts. The company also used sales representatives, supposedly independent Continuing Medical Education, and sham advisory boards to promote the product.
Who were the injured parties?
The injured parties in these cases were the people who used the drugs to attempt to treat their disorders. For example, people who had weight problems, ADHD, substance abuse problems, depression and sexual dysfunctions. Various other products promoted by the company were used for purposes that were falsely advertised. Adolescents were also included in the list of the company’s victims, and these included teenagers and children under 18 who were depressed. The drug actually resulted in an increased risk of suicide among the young demographic taking Paxil.
How has the unethical behavior affected the organization, the individual, and society?
The organization was forced to pay $3 billion, so the case made a financial dent in the company’s operations. The level of impact the $3-billion payment will have on the company was not disclosed, but considering the firm is worth many billions, it only makes a dent in the company’s operations, and the firm may have actually made a profit from the sale of the falsely labeled drugs. The CEO of the company, Andrew Witty, brushed aside the convictions, saying the criminal acts are from a different era of the company, and that the current management is not to blame for the harm that the company did to so many people. He said the company now fires anyone who attempts to participate in such activity, and it has cleaned up its act throughout the firm.
Society has been helped by the conviction because it is the largest health-care fraud settlement in United States history. This is part of the Department of Justice’s push to clean up these firms, and it is part of about $10.2 billion in similar settlements since 2009. This effort hopes to improve the integrity of pharmaceutical companies, which can have such a huge impact on the lives of everyone in America.
How could the unethical behavior be avoided or resolved?
This unethical behavior will likely be more avoided now that the Department of Justice is taking a more active role in ensuring that health-care fraud does not take place. This push is in response to a slew of unethical behavior from health care companies, and the large fines appear to be enough to deter these companies from continuing their unlawful behavior. More enforcement will likely mean less unethical behavior.
Works Cited
Belkin, M. (2012). Pharmaceutical company forced to pay $3 billion over faking research, bribing doctors. The Refusers. Retrieved from
http://healthimpactnews.com/2012/pharmaceutical-company-forced-to-pay-3-billion-over- faking-research-bribing-doctors/