Vioxx and the FDA s Blind Eye

The Truth about the Undeniable Hypocrisy of the FDA

Section 4: Unknown Variables of the FDA’s Acceptance Processes

The 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 Issues

The 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.

Reliance upon Inspection Subsidiaries

Depending 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 causing serous ovarian cancer (Steffen et al., 2020). Gaps in oversight make it possible for companies to bring products to market that are later found to be linked to serious health problems.

Gaps persist because suppliers’ recommendations do not maintain the operational scope of approval that a federal regulator advertises (Haffajee & Mello, 2017; Llamas, 2020; Mulinari & Davis, 2019). The opioid epidemic brought about by drug companies is a perfect example of this problem (Haffajee & Mello, 2017). The companies producing them did not apply safety mechanisms, such as an antagonist agent, or supply a formulation that was tamper-resistant (Haffajee & Mello, 2017). They also neglected to provide recommendations regarding the risk of addiction for certain opioids. Misrepresenting the nature and addictive power of their drugs, pharmaceutical companies like Purdue Pharma were subsequently sued all over the US, as stakeholders sought recompense in the wake of the opioid crisis, which occurred directly under the nose of the FDA. By allowing suppliers to make recommendations outside the scope of approval of that of federal regulation, the FDA essentially handed off responsibility of safety and oversight to the very companies that stood to profit most by bringing their products to market.

Subcontracted Suppliers and Liability

Subcontracted suppliers to pharmaceutical parent companies create an unacceptable evidential trace of liability (Haffajee & Mello, 2017; Llamas, 2020; Mulinari & Davis, 2019). Moreover, they are sometimes assisted by the FDA itself in creating dubious arguments for approval (Mulinari & Davis, 2019). Pharmaceutical companies use guidance provided to them by the FDA to shape their own analyses. In light of industry demands for more permissive regulation, the FDA provides this guidance for the sole purpose of helping the companies it is meant to be regulating pass “inspection” without ever actually being inspected by an independent third party. Essentially, it is no different from the Varsity Blues scandal that revealed how side doors are used to get the children of elite parents into elite schools even though these same children would not ordinarily meet the necessary standards of acceptance. By using subcontracted suppliers, pharmaceutical companies are able to reduce their own “exposure” to risk by stating no knowledge of incompatibilities in production. They are permitted to turn a blind eye on subcontractors because the FDA allows it for the purpose of satisfying these same comanpanies’ demand for looser regulation.

Parent companies such as Pfizer, Johnson & Johnson, and Merck are facades of medications by which culpable liability is questioned (FDA, 2021; Haffajee &Mello, 2017; Sobel, Madigan, & Wang, 2017; Steffen et al., 2020; Verhaegh et al., 2016). Advisory committees have been infiltrated by the pharmaceutical industry, members of which understand how to use political influence to manipulate the FDA’s own leaders (Sanders, 2017). Because the FDA has issued no guidance on sub-regulatory hearings regarding who and who is not permitted to speak, industry insiders prevail in public hearings, betraying the public’s trust and the public’s need for accountability (Sanders, 2017). Companies that should be held liable and held to stringent standards are essentially permitted to engage in self-regulation, as they have become the proverbial foxes in the hen house. The FDA has instead enabled companies to shift liability away to subcontractors, allowing them to escape liability when they are sued by patients who suffered serious side effects from their drugs. This could not be possible unless the FDA permitted it to happen, and as shall be shown in the next section, the integrity of the FDA has been seriously compromised as a direct result of its infiltration by industry lobbyists and personnel.

Section 5: The Compromised Integrity of the FDA

The FDA’s integrity for approval has been impacted by pharmaceutical giants (Campbell et al., 2018; Chang, Dhruva, Chu, Bero, & Redberg 2015; FDA, 2021; Reuters. 2019; Sanders, 2017; Mulinari & Davis, 2019). The largest and best-financed pharmaceutical companies have been able to take up positions on advisory committees, influence reporting within the FDA, and incentivize FDA leaders (with the promise of future positions in their own companies) to look the other way when clinical trials yielding negative results are received. For instance, the FDA does not publicize all the clinical trials submitted and approved by the agency (Chang et al., 2019). In the case of high risk cardiovascular device trials, the FDA publishes trials that depict results significantly different from others submitted; often these differences relate to outcomes within sub-populations, primary endpoints, and risks (Chang et al., 2019). One reason for this selective cherry-picking of which data to publicize and which to keep hidden is the fact that administrators within the FDA go on to work for the pharmaceutical industry and vice versa, as was the case when former FDA head Scott Gottlieb joined the board of directors at Pfizer (Reuters, 2019). The fact that FDA chief regulators end up joining the very companies they are meant to be regulating indicates yet another clear conflict of interest within the regulatory framework that has for all intents and purposes been infiltrated by the industry’s leaders.

Negligence to Issue Recalls

The compromising of integrity is also seen in the apparent negligence of the FDA to administer recalls. The case of Vioxx is one that received a great deal of attention when it became known that harmful side effects were appearing among those who used the drug. Merck’s voluntary recall of Vioxx proved negligent for the FDA, which failed to take any action as the evidence of Vioxx’s danger to the population mounted (Campbell et al., 2018; Chang et al., 2015; Llamas, 2020; Sobel, Madigan, & Wang, 2017). Indeed, the FDA did not issue a recall notice when Merck’s Vioxx was proven to cause organ damage and mortality (Campbell et al., 2018; Chang et al., 2015; Haffajee & Mello, 2017; Llamas, 2020; Sobel, Madigan, & Wang, 2017; Verhaegh et al., 2016). Instead, it permitted Merck to determine for itself whether it should conduct a recall of a proven dangerous drug.

Were the FDA actually an independent agency free from manipulation and influence of the pharmaceutical industry, it would not have hesitated to order the recall for the safety of the public. But it did hesitate and allowed Merck to determine for itself the costs/benefits of keeping the drug on the market vs. facing lawsuits from patients adversely impacted by it. The FDA should be the driving force in regulating the industry, as this is in accordance with its mandate from the public—but because it is beholden to the industry leaders that have infiltrated the agency, it neglects its responsibility to the public at the bequest of industry leaders (Llamas, 2020). In so doing, it violates its mandate and absolves companies, at least for a short term, of any wrongdoing, risking the health of the public in the process.

Ignoring the Evidence

Another indication of this compromised integrity can be found in the fact that both Pfizer and the FDA consider Advil an acceptable Nonsteroidal anti-inflammatory drug (NSAIDs) (Haffajee & Mello, 2017; Llamas, 2020; Sobel, Madigan, & Wang, 2017; Verhaegh et al., 2016). However, not only have studies on Advil uncovered Pfizer and the FDA’s acceptable amount of tubular necrosis of ureters in the kidneys, but other studies have shown the FDA’s willingness to turn a blind eye on trials producing negative results with respect to many other drugs (Haffajee & Mello, 2017; Llamas, 2020; Mulinari & Davis, 2019; Steffen et al., 2020; Verhaegh et al., 2016). From 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.