Vioxx and the FDA 's Blind Eye Capstone Project

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The Truth about the Undeniable Hypocrisy of the FDASection 4: Unknown Variables of the FDA’s Acceptance ProcessesThe FDA’s food and drugs acceptance process includes the risk of unknown variables affecting outcomes (Cooper & Golec, 2019; Haffajee & Mello, 2017; Llamas, 2020; Mulinari & Davis, 2019). One unknown variable is the fact that conflicts of interest arise among panels of experts used to provide advice during committee. Unbiased expert analysis should be the norm, as Congress has sought to exclude experts who have conflicts of interest from serving on FDA drug advisory committees, but this regulation has led to a decline of expertise and a rise in voting approval (Cooper & Golec, 2019). This is one example of how an attempt to curtail bias may have led to an increase in uninformed voting affecting drug approval. Other unknown variables include transparency, reliance upon inspection subsidiaries for recommendations of approval, and use of subcontracted suppliers to pharmaceutical parent companies that confound liability (Cooper & Golec, 2019; Mulinari & Davis, 2019; Sanders, 2017).Transparency IssuesThe method of producing medications for ailments is said to be transparent (FDA, 2021; Haffajee & Mello, 2017; Sanders, 2017; Mulinari & Davis, 2019; Steffen et al., 2020). However, the FDA has been subject to political influence in the past, which veils what should otherwise be a transparent process (Sanders, 2017). As a result, internal biases affect the extent to which scientific analysis is appropriately conducted, including, for instance, the extent to which normalized views of female sexuality deter approval of certain medications deemed “unsafe” by political pundits (Sanders, 2017). Political influence also puts pressure in the other direction as well, as seen in the case of the FDA’s approval of the anti-influenza drug Relenza, which received negative opinions internally and was given a non-approval recommendation by the FDA’s Advisory Committee (Mulinari & Davis, 2019). This case represented a clear division between the scientific culture within the FDA’s organs and the politically-attentive culture of FDA leaders eager to make accommodations to satisfy both Congressional and industry interests (Mulinari & Davis, 2019).It is also important to note that medications submitted to the FDA for acceptance may not require total panels unless the medicine treats a new form of disease (Cooper & Golec, 2019; FDA, 2021; Llamas, 2020; Verhaegh et al., 2016). The FDA’s fast track program allows new drugs to come to market more quickly, but many of these drugs end up requiring a black box warning label in the following years after more studies are conducted; in the interim, patients are at risk of serious side effects (Llamas, 2020). Additionally, even when black box labels are placed on medications, physicians may not see them or may not be aware of the full exposure to risk that patients face when prescribed these medications. The lack of a total panel analysis thus puts patients at risk and places physicians in an unenviable position of prescribing a new medication for an old form of disease.

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Reliance upon Inspection SubsidiariesDepending on the track record of a supplier, the FDA may rely on an inspection subsidiary to send recommendations of approval (Cooper & Golec, 2019; Sobel, Madigan, & Wang, 2017; Steffen et al., 2020). Effects of a drug on a subpopulation may differ from those on the target population, yet this data is sometimes disregarded as only that of the target population is processed, creating problems of external validity (Sobel et al., 2017). When the FDA uses inspection subsidiaries in the recommendation process, the risk of data bias is elevated. This weakness in oversight has led to problems such as the risk of cosmetic talc powders…

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…Advil to Vioxx to the opioid epidemic facilitated by the highly addictive properties in Purdue Pharma’s products, the FDA has shown a terrible track record when it comes to monitoring, evaluating, and approving safe products for public consumption.The FDA’s advisory committees work around trials that would negatively impact pharmaceutical companies’ profits by focusing instead on trials that are crafted and designed so as to produce favorable outcomes. This is typically done by selecting studies that focus only on a specific target population for a certain duration. Yet such trials lack external validity and generalizeability and cannot be considered to be of a gold star standard. In ignoring evidence that might be detrimental to the profits of the industry, the FDA operates as a governmental representative of the industry instead of as its regulator, which is what it should be.The Johnson & Johnson DebacleThe FDA has overlooked Johnson & Johnson’s talcum powder for an unacceptable amount of time (Campbell et al., 2018; Chang et al., 2015; Haffajee & Mello, 2017; Llamas, 2020; Steffen et al., 2020). Johnson & Johnson is one of the largest health care products companies in the world, so it should not be surprising to find that it has a great deal of influence in the FDA. Johnson & Johnson is well known for bringing products to market that might result in lawsuits—but for the company this is just the cost of doing of business: it may end up having to settle a suit at the cost of billions of dollars, but by that point it will have already secured vastly more in profits. But it could not do this without the support of the FDA. Johnson & Johnson faced over 100,000 lawsuits just in 2018 alone, and many of these suits show that the company knew about and….....

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