of the Issue
The issue presented regards the sequence of events that led to theapproval of Vioxx as a treatment regimen for conditions such asosteoarthritis and pain relief among adults. The FDA approved thedrug after a series of clinical trials depicting the drug as beinguseful in the treatment and management of osteoarthritis compared toother drugs that were in the market. At the time, the clinical trialsentailed the use of naproxen for the placebo group. The decision wasarrived at after it was determined that it would be unfair to not touse any drug for those in the control group. The findings of theclinical trials showed massive irregularities with cases such asheart attacks being reported. Despite the conclusions of the clinicaltrial indicating the adverse effects of the drug, the issue wasreported irregularly. For example, 20 cases of heart attacks wereencountered, but only 17 was reported. The irregularities associatedwith the drug did not get the attention of the FDA since it was stillapproved in the year 1999. The damaging effects that followed afterthe introduction of the drug in the market resulted in widespreadcalls to have the drug recalled since it was perceived as the worstdisaster ever encountered in the history of the United States. Merck,the manufacturer of the drug, requested FDA to allow them toadvertise the drug as being more beneficial compared to otherregimens in the market. The continued association by the drugregulatory agency did harm to those who continued to use it. Theeffect was a constitution of Senatorial hearings to investigate theuse of Vioxx which resulted in its final withdrawal from the market.The drug was marketed despite evidence that it had side effects. Itcould be attributed to the possibility of the drug regulatoryagencies not doing their duties as was expected. The continuedmarketing of the drug was wrong because of the adverse effects it waslinked with.
Report on those Interviewed
The incident associated with the drug led to the introduction of adocumentary pertaining the use of Vioxx and its effects. DavidGraham was one of those who was interviewed in the documentary. He isa medical doctor with a specialization in infectious disease. He alsohas a master’s degree in public health. Based on his experience inthe medical field, he is a legitimate expert, and the views heoffered could be relied upon for his expertise. He has publishedvarious articles on infectious diseases including the management ofinfection caused by Helicobacter pylori (Malfertheiner et al., 2012).Gary Null is the other expert interviewed on the issue. He is anutrition expert and holds a Ph.D. in human nutrition and publichealth. He highlights aspects of the preventable disease. He hasauthored various papers including natural ways of dealing withdepression (Null, 2014). Also, Ray Moynihan is an investigativejournalist who is an expert in his field. David Cox, a medicaldoctor, who is a victim was also interviewed and admits to the drughaving had significant adverse effects on him.
Indeed, the documentary provides crucial aspects when it relates tothe concept of incompetence among the drug regulatory agencies. Itconfirms the fact that most of the pharmaceutical companies haveintroduced dangerous drugs to the market but the drug regulatoryagencies such as the FDA either tolerate the issue or fail to imposerestrictions against the same. The documentary is not biased since ithighlights the adverse effects of Vioxx as it should have beenwithout concealing any details. The focus of the documentary of Vioxxserves as a wake-up call to have the FDA take responsibility for manyof the drugs out there that have been approved irregularly.
Malfertheiner, P., Megraud, F., O`Morain, C. A., Atherton, J., Axon,A. T., Bazzoli, F., … & El-Omar, E. M. (2012). Management ofHelicobacter pylori infection—the Maastricht IV/Florence consensusreport. Gut, 61(5), 646-664.
Null, G. (2014). A Natural Approach to Overcoming DEPRESSION.Alternative Medicine, (19), 42.