The pharmaceutical industry is a force for good!
Our opening remark serves as a reminder and maxim within our company’s mission statement of elevating the patient’s and consumer’s perception of the pharmaceutical industry. Now more so than ever in recent times, this maxim of ours is necessary to recalibrate the perception of our industry. For failure to do so will have far reaching consequences, not just upon the pharmaceutical industry but also on public health. As it stands, Big Pharma and the remaining stakeholders within the pharmaceutical industry must, if not currently are, run through a gauntlet consisting of disenfranchised, incredulous and angry members of the public. This brief will look at the current obstacles and challenges that await Big Pharma and other industry players, whilst proffering solutions that go some way to repairing the strained relationship between pharma and the public. The objective of this reconciliation between both pharma and public seeks to restore the lack of confidence and subsequently the trust that has been broken. The future and integrity of the pharmaceutical industry depends on the mending of this relationship.
Beginning with confidence itself, it is its latter crystalised end product of trust, that has been eroded or completely shattered resulting in the pharmaceutical industry being brought into disrepute. The leading contributing factor has been the lack of transparency in commercial activities and the decisions of Pfizer Inc. surrounding their vaccine. The earliest sense of opacity and perceived artifice involved the non-attendance of Albert Bourla pulling out of an initially scheduled European Parliament’s special committee on COVID (COVID committee). Mr. Bourla was not legally bound to attend nor was he subjected to any criminal punishment, as this was not an inquiry. Mr Bourla was intended to speak off the record. Mr. Bourla’s non-attendance proved irksome and did little to quell the committee’s frustration in the pursuit of answer. Another invitation has been extended to Mr Bourla. In Mr. Bourla’s place Janine Small, Pfizer’s Regional President of International Developed Markets stood in. The committee sought to address their concerns surrounding the heavily redacted vaccine purchase contract and the text messages between the Pfizer CEO and EU President Ursula von der Leyen. French MEP and COVI Committee member Veronique Trillet-Lenoir put these questions to Ms. Small. The purpose of Ms. Trillet-Lenoir’s line of questioning was to establish the relevant components about the operations in the manufacturing and delivery of the vaccines. 1 To this, Small answered that the information remains confidential for “competition reasons. This answer in the eyes of the COVI Committee ran contrary to Pfizer’s initial claim of transparency.
Source: Medika.lfe. Janine Small address the COVI Committee.
societal instruments such as politics (policies), the media and science during the pandemic. Reflecting back on the pandemic through the eyes of the public, the UK government’s message over seen by the Chief Medical Officer (CMO), of “Stay at Home Saves Lives, Protect the NHS” because the mantra promulgated by 24 hours news media along with the daily statistics of those infected and killed by the coronavirus. With the machinery of politics and the media- fuelled by the science, there was indeed a great sense of fear and concern. Helpless, in the midst of the pandemic, the only light at the end of this dark tunnel was the arrival of the vaccine. It is here where the greatest scrutiny is applied. It is believed that the vaccine costs Pfizer $1.18 to make which they intended to sell to the US government for $20 and then will subsequently sell them on the consumer market at a price of $130 next year. Given the cost to end-users, the vaccine carries a 10,000% mark up heading into 2023. Pfizer yearly revenue in 2021 jumped from $41.6bn in 2020 to $81.2bn of which $36bn was attributed to vaccine sales.2 IIt is the commercial practices that has not only drawn scrutiny, but indignation given that the initial research conducted by Pfizer’s German partner BioNTech, was funded by the German tax payer.3 From the public’s perception Pfizer has immensely enriched itself off the back of a devastating global tragedy. The challenge now facing Pfizer and the industry as a whole, whether they can adroitly and tactfully allay both questions and concerns around the morality and motive of the pharmaceutical industry. This challenge becomes more complicated when the commercial motive is inextricably affected by the next challenge associated with clinical evidence.
Source: Grocer Kantar 52w/e May 2022
Source: Daily Mail. Pfizer has enjoyed record profits and is projected to enjoy more heading into 2023
Evidence based medicine (EBM) and the ethical principle of autonomy, are the cornerstones of allopathic Western Medicine and during this pandemic, the public witnessed the deviation and erosion of both. Thus, the next challenge facing Big Pharma and the pharmaceutical industry is the public’s disillusionment, specifically, their distrust of the profession’s methodology and expertise. Before a medicinal product is launched on the market and available to the public, the drug candidate (proposed medical product) prior to approval and launch) is extensively tested through a series of clinical phases (Phase I, II & III). The rationale behind the process is to test the safety and therapeutic efficacy for a claimed indication (a condition, illness or disease) as stipulated by the intended marketing authorisation (MA) holder (who tends to be the products proprietor or inventor). During the pandemic a common sound bite in the media was the importance of “flattening the curve”. This meant reducing the r-rate, known as the reproduction rate of the virus through the average number of secondary infections produced by a single infected person.4 The r-rate was an indication of transmission and central to the two lockdowns imposed upon the UK economy and public. A 2021 study revealed that a single dose of a coronavirus vaccine would reduce household transmission of the virus by up to a half. Those given a first dose of either Pfizer or AstraZeneca vaccine- who became infected three weeks later – were between 38% and 49% less likely to pass the virus on than unvaccinated people.5 Therefore, the vaccine was seen as a means to ease restrictions, lift the lockdown and ease into the new normal. However, this did not seem the case.
During the COVI Committee, Janine Small was asked by Dutch MEP Robert Roos, of the JA21 political party, whether Pfizer vaccine was tested on stopping the transmission of the virus before entering the market. Small replied, “No”. She further added:
“…We had to really move at the speed of science to really understand what is taking place with the market.”
This is harrowing. There was no data, no clinical evidence and hence no science for a pharmaceutical product making claims towards halving transmission as part of a vaccine drive. For a profession and industry that prides itself on prudence and clinical evidence, this was nothing short of opportunistic, rash and reckless. This answer was not only injurious to the sector, it brought the whole pharmaceutical industry into disrepute. On the subject of injuries, there have been reports of recipients of the Pfizer vaccine experiencing myocarditis and heart attacks despite having no history of cardiac issues.6 Other vaccines have caused paralysis in a 12 year old girl, concerns surrounding fertility and premature deaths amongst healthy and fit individuals.7 From data collated between 9/12/20 and 20/04/22 for the mRNA Pfizer/BioNTech vaccine and 29th September and 28th September 2022 for AstraZeneca vaccine. The rate of vaccine deaths is now higher than COVID deaths are, with the figures showing 1,227 deaths plus 149 miscarriages. 8 9 The sudden death of adults in the last 18 months across the globe is to be covered in an up and coming private documentary entitled “Died Suddenly” streaming 21st November 2022.10 The industry must brace itself for the question that are sure to follow.
Aside from the untrialled claims of transmission and the climbing death tolls, as a result of the erosion of EBM, the inherent right of autonomy had been attacked. Those that expressed concern and thus, sought more information to arrive at a position of informed consent were lambasted and labelled as “antivaxxers”, “covidiots”, “flat-earthers” and conspiracy theorists. Again, the combination of the media apparatus and the experts of the pharmacy industry created a toxic and divisive environment. “The Vaccinated” and “The Unvaccinated”. The Clean” and “The Unclean.” Adding to this hostile climate came the truly chilling policy imposed, by the then government and Health Secretary Savid Javid, on NHS staff and other care workers of
“No Jab, No Job!”
This policy was a direct contradiction of the Public Health (Control of Disease) Act 1984 and the Coronavirus Act 2020 and despite the government revoking this policy in February 2022, the damage had already been done. The sweeping disregard for the importance of EBM and ethics has left confidence and trust in the pharmaceutical industry in tatters. Aside, from rebuilding this broken trust, Big Pharma has created a more hostile and premier challenge with immediate consequences.
The final challenge to the pharmaceutical industry and one with immediate consequences is the rebellious spirit and “awakening” within not only the UK, but also the global public. This rebellious stance, fuelled by skepticism, poses a real danger to non-adherence and non-compliance with prescribed medication or the refusal to seek medical treatment all together. This is a trend already visible amongst minority ethnic groups, a group most susceptible to health inequalities.11 12 This rebellious spirit will exacerbate the already poor uptake and falling rate of childhood vaccinations across all programs.13 To tackle this challenge with any means of success there must be an acknowledgment that the leverage within the power dynamic between healthcare sector (including pharmaceutical companies, health institutions and healthcare professionals) and the public is no longer tilted in favour of the healthcare sector. The information age has not only dispelled the mystique surrounding the healthcare sector, it has recalibrated it to be a more even keel. This once lopsided relationship has seen the public question the necessity of the vaccines against that of an approved and generic medicine that is clinically efficacious and cheaper medicine in the form of Ivermectin.
Ivermectin is an oral anti-parasitic agent and across a meta-analyses of 18 randomised-controlled treatment trials, the administration of Ivermectin in COVID-19 patients was statistically significant in the reduction in mortality, time to clinical recovery, and time to viral clearance.14 The efficacy of
Ivermectin has been described as miraculous” by Dr. Pierre Kory at a COVID Committee in the US considering the devastation COVID-19 wreaked on the African-American and Latino community. When renowned podcaster Joe Rogan purchased Ivermectin, he was chastised for obtaining Ivermectin (most likely prescribed to him), which the media erroneously and disparagingly labelled as “horse dewormer” and not safe or approved to be used for human use. The perpetuated falsehood has served as casus belli against the perceived corruption and dishonesty of the pharma sector, a stance that in of itself will contribute to the proliferation and continued use of counterfeit medication as a means to gain one up on the “greed” of the pharmaceutical corporations. The furore that the Joe Rogan story created has further raised questions and scrutiny as to the motive and veracity of the pharmaceutical industry surrounding the vaccines and now future therapeutics.
Distrusting pharmaceutical companies, coupled with disinterest and a sense of complacency, will lead to non-adherence, non-compliance and the potential rise in counterfeit medication among members of the public. This would pose not just a public health crisis in the UK, but around the world. As a sector we must act fast to address this.
The new-wave of rebellious scrutiny has been led by the likes of Candace Owens through her “Shot in the Dark” series, available on social media platform Parler, and has further emboldened a leading vaccine researcher and campaigner in Robert F. Kennedy Jr. These voices and others will not be diminished. As it stands, they have laid down the gauntlet for us. From the pharmaceutical industry’s current position here to where we would like the pharmaceutical industry to be, the industry must pass through this difficult corridor and scrutinous passage that makes up the awaiting gauntlet. Therefore, we prose the following solutions for its successful navigation.
The first of our proposed solutions is to address the concerns around transparency. The industry must accept and address the gauntlet’s response to transparency with skepticism if Big Pharma and the pharmaceutical industry are to survive the gauntlet. To achieve successful navigation the industry must show its working and hence, must be willing to present, explain and share clinical data surrounding medicinal products in particularly vaccines. It is imperative that the public has confidence with the medicinal products, public health leaders and drafted government policies. Confidence can only be achieved through effective and correctly practiced EBM. Only through these means can trust be established.
The next solution may be far more challenging and even out of our hands. Nevertheless, it is by no means a reason not to try. The pharmaceutical industry especially Big Pharma, must do all they can to ensure responsible media coverage on matters associated with medicine and public health. For clarity, we use the term media to include not just TV coverage but print, online and social media. Continued misinformation, inaccuracy and politicised sensationalism draw scorn and calls from the public of “propaganda”, ”profiteering” and “fear-mongering”. This is not conducive to the industry and drives a wedge in between the necessary relationship between the pharmaceutical industry and the public. This could be addressed in two ways. One way would be educating the media. This could be through better briefing to any media outlets and channels. The aim would be to set the record straight factually by explaining the medicinal product’s mechanism of action, or the illness or health condition of topic. Attending non-legally binding committee hearings or panels would be a positive and welcomed step in the right direction on this front. Equally, the media too are educators (and many within the media industry would share this notion too) and thus, there indeed exists scope and necessity for sensible unified messaging against medical expertise and statistical evidence. The second option for sensible media coverage is for pharmaceutical companies and pharma stakeholders to be proactive, instead of reactive and hence, control the narrative from the outset. This needn’t be hostile or delivered in a belittling fashion, but using clinical expertise and communicating directly with the public in a manner that restores confidence and subsequently trust from the outset. In a world of decentralised media, led by social media, with many platforms for consumer engagement, a media strategy of this kind would be a welcomed remedy and most effective.
In conclusion, Big Pharma and pharmaceutical industry find themselves at a critical juncture. Given the current public sentiment, the entire pharmaceutical industry faces an existential battle for its future. There will be a need to fight. Specific battles will need to be fought to successfully navigate this gauntlet. These battles will not be fought with money, or through PR, nor l through lip service. Rather this battle will only be won through transparency. Transparency in clinical and scientific data. Transparency in commercial operations that neither obfuscates or injurious to commercial competition in a free market. And above all, transparency in veracity and motive. This battle will need to be won on the recognition and respect of bioethical principle of autonomy, for any acts that threaten the existence or acknowledgment will result in the surrendering of key battlegrounds in the fight for transparency. Adopting these approaches before engaging in these battles within the gauntlet will serve as the only remedy to soothe the current restless and rebellious spirit, whilst mending the eroded bridge of confidence between Pharma and public.
The pharmaceutical industry is a force for good and we, Nnadi’s Healthcare & Pharmaceuticals, shall help to see the industry come out of the other side of this gauntlet to prove it.
© All rights reserved, Nnadi’s Healthcare & Pharmaceuticals Limited, 2022.
References:
1. Clara Bauer-Babef. Pfizer remains discreet about COVID vaccine purchase contracts. https://www.euractiv.com/section/coronavirus/news/pfizer-remains-discreet-about-covid-vaccine-purchase-contracts/ [accessed 01 November 2022]
2. Mansur Shaheen. Pfizer cashes in on pandemic: Pharma giant plans to sell its vaccine with a 10,000% markup — despite revenues tripling and CEO pocketing $50m during Covid crisis. https://www.dailymail.co.uk/health/article-11357661/How-Pfizer-plans-sell-Covid-vaccine-10-000-markup.html [accessed 04 November 2022]
3. Ibid.
4.Gov.uk. The R-value and growth rate. https://www.gov.uk/guidance/the-r-value-and-growth-rate [accessed 05 Nov 2022]
5. BBC News. Covid: One dose of vaccine halves transmission-study. https://www.bbc.co.uk/news/health-56904993#comments [accessed 05 November 2022]
6. Tara Haelle. Why is it so hard to compensate people for serious vaccine side effects? National Geographic. https://www.nationalgeographic.com/science/article/why-is-it-so-hard-to-compensate-people-for-serious-vaccine-side-effects [accessed 05 November 2022]
7. Gillian Jamieson. Covid vaccines, treatments, mental health and the future. Supplementary Written Evidence. https://committees.parliament.uk/writtenevidence/36788/html/ [accessed 05 November 2022]
8. Ibid https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1072043/COVID-19_mRNA_Pfizer-_BioNTech_vaccine_analysis_print.pdf [accessed 05 November 2022]
9. Ibid https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1115342/COVID 19_Vaccine_AstraZeneca_analysis_print_-_26OCT22.pdf [accessed 05 November 2022]
10. Died Suddenly- The Documentary. The Stew Peters Network. https://diedsuddenly.info/ [accessed 05 November 2022]
11. Kadambari S, Vanderslott S. Lessons about COVID-19 vaccine hesitancy among minority ethnic people in the UK. The Lancet Infect Dis. 2021. 21; (9) P1204-1206.
12. Khan S. Rebuilding trust in medicine among ethnic minority communities. BMA. 2022. https://www.bma.org.uk/news-and-opinion/rebuilding-trust-in-medicine-among-ethnic-minority-communities [accessed 05 November 2022]
13. Gov.uk. Parents warned about dangers of children missing vaccines. Press release. https://www.gov.uk/government/news/parents-warned-about-dangers-of-children-missing-vaccines [accessed 05 November 2022]
14. Kory P, Meduri GU, Varon J Iglesias J , Marik PE. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Am J Therap. 2021. 28 (3) pe299-e318