“The University of the North Pole” is a name that I made up. What I am trying to do with this pretend examination is to present ideas in a different way.
Like everyone else I often write down ideas as statements, as facts. However, I cannot always do that when there are lots of things which I am unsure about.
Is it possible to write about ideas instead as questions, as things that I would like to know?
There is a lot that we don’t know for sure. They are not yet settled. Maybe they need the judgement of a court hearing. Sometimes the issues that are important have not happened yet and may never happen. They are only possibilities. There has been a lot of uncertainty about the Covid pandemic.
Too often we do not know about situations because things are being kept from us, we are not being told contexts.
So let’s discuss and explore questions…
In case you are wondering why this is relevant to the themes of “Credo”… The exploration which these questions hopefully elicit concerns how “disaster capitalism” works in the health crisis that follows when economic growth comes to an end….
University of the North Pole
Part One – Medicine, Big Pharma and Regulatory Capture
Covid Treatment Ethics
Answer all questions
1. According to Jacob Bronowkski “That is the essence of science: ask an impertinent question and you are on the way to a pertinent answer”. Answer (a) and (b)
(a) What is the solution to the fact that governments, their regulatory agencies and the drug companies go to great lengths to prevent themselves being answerable – for example, pleading commercial secrecy is more important than patient and public safety, that making money is more important than being transparent?
(b) Discuss the idea that raw data should be made available to independent scientists who could check medicines and treatments for safety and efficacy?
2. Read this quote from an editor of the Lancet in 2015 and say whether you think it also applies to the emerging treatment approaches for Covid 19. Explain your answer and include reference to the Surgisphere scandal when the Lancet had to withdraw a study that turned out to be based on falsified data about the effectiveness of hydroxychloroquine as a treatment for Covid.
“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60696-1/fulltext
3. What conclusions should doctors and patients draw from the fact that all the big pharmaceutical companies have huge criminal records? (For the violation records of the main vaccine manufacturers see Violation Tracker website at https://violationtracker.goodjobsfirst.org/parent/pfizer https://violationtracker.goodjobsfirst.org/prog.php?parent=astrazeneca https://violationtracker.goodjobsfirst.org/prog.php?parent=johnson-and-johnson
4. “Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. “ (Ben Goldacre in “Bad Pharma”) Discuss the implications for potential treatments for Covid 19.
5. In the foreword to the 2013 book by Peter Gøtzsche “Deadly Medicines and Organised Crime, How Big Pharma has Corrupted Healthcare” a former editor in chief of the British Medical Journal, summarises the state of medical ethics as follows:
(Gøtzsche) shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators, and politicians. These are the methods of the mob. (Foreword by Richard Smith )
Discuss the proposition that Big Pharma has corrupted large parts of the health service and say what should be done about it given that repeated attempts at reform over many years have so far failed.
6. “Medical journals have become an underrecognised obstacle to scientific truth telling Journals have devolved into information laundering operations for the pharmaceutical industry.” Richard Horton, Editor in Chief, the Lancet. Can the medical journals be trusted in the light of their financial dependence on pharmaceutical industry advertising and other financial arrangements? https://www.youtube.com/watch?v=UAEAWyfuEWY
7. Of the growing links between business and Universities, a former President of Harvard University, Derek Bok, has written that “….making money in the world of commerce often comes with a Faustian bargain in which universities have to compromise their basic values – and thereby risk their very souls – “ (Bok, D; 2003, Universities in the Marketplace: The Commercialisation of Higher Education, Princeton University Press, 199-200). Answer (a) and (b)
(a) Are academics any longer to be regarded as reliable sources of information when they are so beholden to Big Pharma, have been corrupted by ghost writing of medical articles (institutionalised plagarism) and by high fees paid by pharma marketing departments who have built up particular academics as faux “key opinion leaders, to (covertly ) market their drugs? (Jureidini J and McHenry L B “The Illusion of Evidence Based Medicine. Exposing the crisis of credibility in clinical research” Wakefield 2020 Chapter 5 )
(b) The proper organisation of universities is as “knowledge commons” dedicated to education and impartial research. This means ending ALL private commercial sponsorship of academic activity. The proper way of funding universities is by taxation, including of commercial activity. Discuss.
8. “There is typically a revolving door relationship between executives from drug companies who get positions on the committees guiding regulatory agencies and then later go back to senior positions managing drug companies.” Discuss the mechanisms of “regulatory capture” that neutralise what are supposed to be state supervision of safety regulations. (Jureidini and McHenry, The Illusion of Evidence Based Medicine pp 185-186 )
9. “Compromised regulatory agencies have an easy time when they don’t want to deal with the adverse effects and harms of particular activities. They assume there will be no problems, don’t look or encourage observation or make it very difficult to gather evidence”. Discuss this claim and say whether you think that the MHRA in the UK, or the European Medicines Agency or the Centres for Disease Control in the USA provide examples.
10. Why is “absence of evidence” not the same as “evidence of absence” when it comes to harms and adverse effects of prescribed medication and medical procedures like injections?
11. According to the head of the MHRA, Dr June Raine, “Most things people say in Yellow Card Reports aren’t linked to the vaccines at all.”
(a) Propose a process to find the evidence that would verify or falsify this statement – e.g. a Freedom of Information Act request asking for what % of Yellow Card reports are not linked to the vaccines in any way as well as information of what is the statistical breakdown of remaining confirmed adverse effects which have been found to be linked to the vaccines.
(b) If no evidence exists because no investigation has taken place that can provide evidence suggest a strategy to get the media to publicise this.
12. A clever design of clinical trial methodology can be used to to discredit already existing drugs which are competitors to a new candidate medicine. Describe such a trial methodology to discredit an older drug which is most effective when used for early intervention.
13. Overdosing by design. Answer (a) and (b)
(a)In the Recovery trials to test the effectiveness of hydroxychloroquine as a drug promoted for early use in Covid 19 the drug was prescribed to patients at a late stage of the illness. It was also prescribed at potentially lethal doses. Is this compatible with the Hippocratic Oath – to do no harm?https://www.francesoir.fr/politique-monde/oxford-recovery-et-solidarity-overdosage-two-clinical-trials-acts-considered
(b) To show drugs in a favourable light clinical trials can be designed to include a competing drug. The competing drug is used for comparison purposes in the control sample. The dose for the comparison drug is set at a very high level. When used in clinical trials involving depressed children these high doses of the comparison drugs are called “elephant doses”. The adverse effects with the comparison drug in the control sample then appears to throw the milder effects other drug in a favourable light. https://www.youtube.com/watch?v=UAEAWyfuEWY
Which of the following describes this kind of ethical misconduct – (i) Scientific fraud (ii ) assault on patients with intention to cause actual bodily harm and potentially death (iii) child abuse?
14. Answer (a) and (b)
(a) Explain the concept of informed consent.
(b) The normal time for trials for a new vaccine are three to 10 years during which time long run safety issues have time to emerge. Is it possible to inform the public about risks if they are issued for mass public use in less than a year?
15. According to a peer reviewed study in the International Jnl of Clinical Practice:
“The specific and significant COVID-19 risk of ADE (antibody-dependent enhancement) should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.” https://pubmed.ncbi.nlm.nih.gov/33113270/
Discuss what “prominently and independently” involves as well as the ethical and legal implications (in the UK) where this that not taken place or not included in literature and publicity about the vaccines.
16. The vaccines have been tested by the companies that developed them but the raw data from their trials was not made available. For example Peter Doshi in the BMJ questions the large number of suspected but not confirmed cases in the trial data. “If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy.” Then there were 371 individuals excluded in the Pfizer efficacy analysis for breach of study protocols. Doshi asks “What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group?” https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/
Given the criminal records of these companies why should we trust them?
17. “Using the MHRA (Medicines and Healthcare products Regulatory Agency) reporting system for adverse effects following the vaccine is a shockingly unlikely thing to happen among hospital doctors where I work. From many discussions I have had over the years, I know that this is also the case in various hospitals where colleagues work. None have had any training in using the online system and many seem surprised to learn of its existence. The net result is that many adverse events do not get reported by medics”. Article in “Conservative Woman” March 13th 2021 https://www.conservativewoman.co.uk/are-doctors-failing-to-record-bad-reactions-to-covid-jabs/
18. “While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees…If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse”. https://truthout.org/articles/former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety/
How would one find out if the UK’s MHRA is any more ethical than the US Food and Drugs Administration as described by this former employee? Draft Freedom of Information Act requests which might help ascertain if the MHRA is a trustworthy and competent agency.
19. Draft a Freedom of Information Act request to discover what, if anything, the MHRA has done about revelations uncovered by the European Medicines Agency that the process of Covid vaccine manufacture had involved quality variability between different batches of the vaccines in regard to: (a) Microbiological contamination; (b) whether buffers (solvents) are free of RNAses which would degrade the RNA in the vaccines making them ineffective (c) whether there are any DNA contaminants remaining after the manufacturing process is finished (d) whether the vaccine is still viable after transportation (e) sterility of the vaccine vial. http://enformtk.u-aizu.ac.jp/howard/gcep_dr_vanessa_schmidt_krueger/
20. Consider this question and answer directed to a whistle-blower previously at the US Food and Drugs Administration in 2012 published originally in the “Truthout” blog – then discuss whether you think that the whistle-blower’s safety recommendation also applies to the Covid 19 vaccine:
MR: What are some of the ways in which safety risks were minimized in drug evaluation and review?
RK: Well, first of all I think most people would be shocked at how malleable safety data is. Human studies are usually too short and the number of subjects in them too small to adequately characterize the most dangerous risks. That’s why even a single case has to be taken seriously. A safety signal from any study – and not just safety data from short term efficacy and safety studies (used for labelling) – needs to be evaluated. This means data from long term safety studies needs to be evaluated as well as the data from even longer, ongoing safety studies and from clinical pharmacology studies. https://truthout.org/articles/former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety/
21. “Vaccinating children and young people when the risk of harm from the vaccines is greater than the risk of harm to them from covid 19 is unjustified, unethical, an assault on the children and child abuse. The ungrounded argument that children might spread the virus, even if it were true sets a precedent that it is acceptable to risk harm to some people in order to reduce the risk to others. In Kantian ethics actions should be evaluated by the precedents that they set more generally and a right to harm some to save others opens a Pandora’s box of ethical precedents. Considering that children have a right to anticipate at least 60 or 70 years ahead of them whereas those who are vulnerable are mostly near the end of their lives this is even more unjustifiable”. Discuss this ethical judgement. (Adverse events experienced by 12-15 year olds after the Pfizer Vaccine can be found in tables 5 and 6 at https://www.fda.gov/media/144413/download . )
22. In order to get emergency use authorisation for the vaccines before phase three trials were completed it was necessary that there be no alternative to them. Yet many doctors consider that there is evidence enough to consider drugs like ivermectin highly effective and have a good safety record too. So these constituted an alternative. Several small random controlled trials have been aggregated in meta-analyses. Recommendations from the World Health Organisation and other national medicinal authorities have however blocked ivermectin on arguments claiming inadequate research and evidence quality. This implied that only proof from very large but expensive trials would provide good enough evidence. https://covid19criticalcare.com/videos-and-press/flccc-releases/covid-ivermectin-and-the-crime-of-the-century-podcast-with-dr-pierre-kory/
Is this intended to achieve “a perfect evidence requirement to undermine good enough evidence” bearing in mind that only Big Pharma have enough money to pay for large trials but no incentive to see them funded nor to organise them honestly.
23. “We are at a remarkable juncture in medical history where rigorous scientific evidence, our training and experience, the tools that we use to heal and our connection to our patients are being systematically undermined by relentless misinformation stemming from corporate greed.” Closing Speech, Dr Tess Lawrie, International Ivermectin Covid Conference April 2021 https://www.e-bmc.co.uk/
Give your view on her claim that the resource intensity of large randomised trials play into the hands of big Pharma which will not fund research into competing drugs where they stand to make no money – even if such drugs show considerable promise in small trials and observational studies.
24. Where drugs which show therapeutic effects are blocked from prescription and distribution and ill people die can this be understood as: (a) A Violation of the Hippocratic Oath? (b) Homicide? (c) Malfeasance when applied by public authorities in conjunction with cronies in Big Pharma? https://covid19criticalcare.com/videos-and-press/flccc-releases/covid-ivermectin-and-the-crime-of-the-century-podcast-with-dr-pierre-kory/