The Double Standards of the FDA

THE TRUTH

The Truth about the Undeniable Hypocrisy of the FDA

How can one trust the daily supplement, hormone replacement, or pharmaceutical intervention that could be ingested with the political or pharmaceutical agenda? There is a need for the Food and Drug Administration (FDA) to realign its requisite moral objectivity that had American population health and wellbeing at its hands since the agency uses media and patient-provider avenues for the purpose of public portrayal. It has been apparent lately that the clinical trials, reactions for subduing adverse prescription, and endorsements of non-regulated foods and medications have been conducted for special interests and monetary gains that are backed by big businesses and pharmaceuticals. This paper aims at reviewing previous literature regarding the FDA’s problematic inconsistencies, its review on subsidiaries, authorization, and implementation of food and drug policies. Other highlighted parts of the paper would include Black box indications, expediting of drug trials, and the use of FDA power in certain matters of publications of the data that submitted to them for approval by the manufacturers and what is actually discerned by the public.

Section 6: The Clinical Evidence

Current clinical medication trials are pricked with clinical immorality. They show that medication used for one control group might not have the same effect or could be hypothesized for the others (Campbell et al., 2018; Chang et al., 2015; Llamas, 2020; Lupkin, 2017; Mulinari & Davis, 2019). Scanty literature is present showing Metformin’s use is associated with a lesser prevalence of dementia, particularly among those people who are using it for the management of diabetes. People who do not have diabetes have not shown any signs and even no such previous research support this fact. Significant reduction in people suffering from diabetes was only tested for this purpose, which corroborates the finding that the use of Metformin for eradicating signs of dementia is not supported for those who do not suffer from diabetes. Since Metformin is conceived to be based on one clinical trial for benefitting Alzheimer’s and diabetic patients with the same illness, it is used for creating a reduced risk of dementia but only the basis of one trial. It is therefore inferred that the use of Metformin could not be suggested for patients without diabetes for the treatment of dementia. More investigations need to be conducted for FDA to be fully sure of its prescription to the patients with or without diabetes as there is a possibility that certain demographic, environmental, and social factors come into play while observing the effects of how the medicine works for different individuals differently. Without certainty, FDA should consider the circulation of Metformin for those who are without diabetes could incur side effects as certain studies in this category reinforced the finding that worse cognitive performance in metformin users was observed while making adjustments for vitamin B12 (Campbell et al., 2018).

It has become common that FDA has been over-extending its authority for these purposes (Chang et al., 2015; Haffajee & Mello, 2017; Llamas, 2020; Reuters. 2019; Sobel, Madigan, & Wang, 2017). It has been clearly indicated in research studies that FDA uses its power and changes the submitted data and the published reports expose utterly different data to the public (Chang et al., 2015). The manufacturers of new devices or medicines submit their relevant findings for the approval of the FDA whereas FDA’s publications differ from what has been submitted to them. Fatalities, safety, and effectiveness have been altered and provided a whole new outlook for the health industry that has been immensely relying on FDA’s approvals. The unfavorable results of the medicines remain unpublished mostly in the peer-review journals from which the medical professionals and common public remain unaware. By making a comparison of the manufacturers’ requests for publications with the number of publications actually done by the FDA, there was a huge contrast. It has even been mentioned that the FDA did not contact them for further updates or notifications on the devices’ publications and the data came out altered in published trials. It seems that FDA has been exercising its power in this regard as to certain data to be exposed while others not to the public. The summaries and declarations in the available data in the publications have been transformed while making use of some restricted parts that still remain invisible to the common public and medical specialists. It appears that FDA wants to reserve some data from being critically analyzed if it was published in peer review journals. Long delays have been witnessed in this respect as cardiovascular trials and their results remained unknown for an unexpected time period.

The Black box has been under the spotlight for giving attention to a medication that has the potential side effect of provoking or risking death (Chang et al., 2015; Llamas, 2020; Lupkin, 2017; Sobel, Madigan, & Wang, 2017; Steffen et al., 2020; Verhaegh et al., 2016). Trump administration has been conducting the act of expediting the process of faster approvals but these decisions have given certain consequences that have forced the FDA to re-think its actions for the sake of public health safety. On average, it took 4.2 years to make the drugs approved but due to this faster process now, there were more problematic magnitudes observed in psychiatric drugs and biologic drugs (Lupkin, 2017). Subsequently, a higher rate of safety interventions from the physicians and medical experts have to be devised for those patients who were taking those drugs that have been in the market after a speeded approval since they were deficient in proper research and trials. Without adequate testing and unverified reports of the trials, it becomes a heavy burden on the FDA’s shoulders for determining the repercussions of public health safety without evidence-based practice in the entire systematic procedure. A similar case was seen when Bextra and Zelnorm were removed from the market after seeing negative impacts on the health of cardiovascular patients (Lupkin, 2017).

It is surmised that the importance of surveillance should be recognized by FDA so that faults in speedy trials and their effects on the health of the American population should be predicted beforehand. The substandard or falsified products that cause more harm than cure should be stopped through this strategy so that FDA could know that medicines, vaccines, and diagnostic tests are not included in the organizational commitments to its community. Also, it causes more harm to the economy as many medicines have to be withdrawn from the market and the more economic burden has to be borne by the government for the treatment of the affected ones.

Even after the drugs are on the market for a few years, expedited theoretical drug trials should be required for indications of Black box warnings, especially in times of pandemic like Covid-19 when vaccinations are critical for decreasing mortality rates. The drug-developmental cycle is usually lengthy, as has been mentioned earlier that FDA approval requires 4.2 years on average for this process, it still is a work of proactive, collaborative, and vigilant testing to safely monitor the drugs. Even if the drugs have been in the market for a few years, Black box warnings are still mandatory to prevent the adverse effects of expedited drugs from being apparent in any stage of the patient’s life and further inviting costs on the economic wheel. The government had to incur costs in times of pandemic when sudden medical budgets had to be approved for making the lives of the Covid victims better. Nevertheless, certain Covid vaccines have been reported to create rare effects on adolescents and adults in terms of heart inflammation that should be included in the label warnings on the packaging (Dunleavy, 2021).

References

Campbell, J., Stephenson, M., de Courten, B., Chapman, I., Bellman, S., & Aromataris, E. (2018). Metformin use associated with reduced risk of dementia in patients with diabetes: A systematic review and meta-analysis. Journal of Alzheimer's Disease, 65(4), 1225–1236. https://doi.org/10.3233/JAD-180263