Evidence-based medicine has been corrupted by corporate interests, failed regulation and commercialisation of academia, which act to suppress negative trial results, conceal adverse events and withhold raw data from the academic research community, according to a peer-reviewed article in the British Medical Journal by Jon Jureidini of the University of Adelaide and Leemon B. McHenry of California State University.
Medicine is largely dominated by a small number of very large pharmaceutical companies that compete for market share, but are effectively united in their efforts to expanding that market. The short term stimulus to biomedical research because of privatisation has been celebrated by free market champions, but the unintended, long term consequences for medicine have been severe. Scientific progress is thwarted by the ownership of data and knowledge because industry suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. Patients die because of the adverse impact of commercial interests on the research agenda, universities, and regulators.
The pharmaceutical industry’s responsibility to its shareholders means that priority must be given to their hierarchical power structures, product loyalty, and public relations propaganda over scientific integrity. Although universities have always been elite institutions prone to influence through endowments, they have long laid claim to being guardians of truth and the moral conscience of society. But in the face of inadequate government funding, they have adopted a neo-liberal market approach, actively seeking pharmaceutical funding on commercial terms. As a result, university departments become instruments of industry: through company control of the research agenda and ghostwriting of medical journal articles and continuing medical education, academics become agents for the promotion of commercial products. When scandals involving industry-academe partnership are exposed in the mainstream media, trust in academic institutions is weakened and the vision of an open society is betrayed.
The corporate university also compromises the concept of academic leadership. Deans who reached their leadership positions by virtue of distinguished contributions to their disciplines have in places been replaced with fundraisers and academic managers, who are forced to demonstrate their profitability or show how they can attract corporate sponsors. In medicine, those who succeed in academia are likely to be key opinion leaders (KOLs in marketing parlance), whose careers can be advanced through the opportunities provided by industry. Potential KOLs are selected based on a complex array of profiling activities carried out by companies, for example, physicians are selected based on their influence on prescribing habits of other physicians. KOLs are sought out by industry for this influence and for the prestige that their university affiliation brings to the branding of the company’s products. As well paid members of pharmaceutical advisory boards and speakers’ bureaus, KOLs present results of industry trials at medical conferences and in continuing medical education. Instead of acting as independent, disinterested scientists and critically evaluating a drug’s performance, they become what marketing executives refer to as “product champions.”
I suspect the authors’ confidence in Government and public funding to free medicine from predetermined agendas is misplaced, as the Government propaganda during the pandemic (and on numerous other issues) has shown. But the points about the corruptions that the dominance of big pharmaceutical companies bring to the development and testing of medicine deserve to be taken seriously.
We’re publishing today a piece by retired Pharmaceutical Research and Development Scientist Dr. John D. Flack, who is appalled that the gene-technology vaccines now being used for COVID-19 were not subject to the standard safety studies usually required for novel genetic-based medicines. Dr. Flack, a member of HART, was involved in pharmaceutical research throughout his career and served as Director of Safety Evaluation for a pharmaceutical company, so when it comes to safety studies of new drugs he knows what’s he’s talking about. Here’s an excerpt:
It seems to me that the regulatory authorities may have considered this new class of medicine as a vaccine and followed the toxicology guidelines for conventional vaccines. But as discussed above, they are not vaccines in the conventional sense. They are injections of a laboratory synthesised gene sequence – what in previous decades we would have called a new chemical entity (NCE). Furthermore, they are being given, not as a single dose, but because of their limited efficacy as repeated injections – called boosters. On the hoof, it seems, it is decided that extra doses must be given. How can this possibly be unless supported by the appropriate safety studies? And how convenient for the worldwide authorities regulating the approval of new medicines that the Centers for Disease Control (CDC) in the USA modified the definitions of vaccine and vaccination – to allow for the new “ways in which vaccines can be administered” – to embrace this new technology that would be previously classed as an NCE. Sorry, but simply changing the definition of the term vaccine to fit the properties of these novel injections doesn’t obviate the need to conduct the appropriate studies by which their safety can properly be assessed. That is why I use the term vaccine in quotation marks or simply describe them as injections.
So how would I design a package of studies to assess the safety of these novel ‘vaccines’?
Here is a list of preclinical toxicology studies that in my view should have been performed before regulatory authorities gave their approval to the licensing of these novel therapies under the Government emergency powers:
1. Acute toxicity assessment in rodents and possibly pigs to assess the local and intramuscular irritancy. The pig is a very good model for assessing human muscle irritancy. 2. A 14 day repeat-dose study in two animal species at three different dose levels of the active moiety i.e., the spike protein. The objective of these studies would be to achieve a no effect dose level and to identify those organs in the body that would be adversely affected at high doses. In other words, establish the potential target organs of toxicity in the clinical setting. 3. Pharmacology studies in appropriate animal species to establish any possible adverse effects on the normal functioning of the body vital organs. Emphasis being paid on the cardiovascular and blood systems as these had been clearly established as targets of the SARS-CoV-2 virus through the spike protein and its known attachment to angiotensin converting enzyme 2 (ACE2) receptors in exerting its pathological effects. 4. Pharmacokinetic studies to establish the distribution of the gene sequence to other parts of the body following intramuscular injection of the gene sequence and the concentrations of spike protein in the blood after intramuscular injection.
These would have been the minimum of studies carried out prior to any trials in humans. The data from these studies would determine whether there was a sufficient margin of difference between the dose giving rise to the beneficial immunogenic effect and that causing any adverse effects to justify proceeding with clinical trials. In other words, determine the ‘therapeutic ratio’. As discussed above, this ratio would need to be high considering the medicine would be given to healthy people not patients with disease, when the ratio can be much smaller.
The Wellcome Trust – Britain’s biggest independent funder of medical research, set up by the man whose pharmaceutical firm became GlaxoSmithKline – has called for coronavirus to be “treated like the common cold”. The Telegraph has the story.
Nick Moakes, the charity’s Chief Investment Officer, said restrictions were no longer economically justified and it was time to “live with” coronavirus.
“I don’t think it can mean going back into regular lockdowns because it is just not economically viable. We don’t do that for the flu, we don’t do that for the common cold,” he said.
“The best case end game is where it is treated like the common cold, like flu. And on an annual basis, those that are vulnerable get a jab against it – and the rest of us have built up a degree of immunity that protects us sufficiently. And we do live with it.”
His comments are at odds with those of the WHO Senior Emergency Officer Dr. Catherine Smallwood, who said on Tuesday that we are “nowhere near” treating Covid as an endemic virus.
However, they are in line with those of Professor David Heymann of the London School of Hygiene and Tropical Medicine (LSHTM), who has suggested in a Chatham House online briefing that the U.K. is seeing the virus become endemic. According to the Telegraph:
Dr. Anthony Fauci, the White House Chief Medical Adviser, has spoken of his confidence that existing vaccines will be able to effectively target the Omicron variant, and that a new booster jab created to specifically fight this new strain is not needed. However, Fauci has said that pharmaceutical companies will produce vaccines that are variant-specific regardless. RThas the story.
“I’m not so sure that we’re going to have to get a variant-specific boost vaccine to get an adequate protection from Omicron,” Fauci told the health news website STAT on Friday. “Because if you look at protection against variants, it appears to relate to the level of immunity and the breadth of the immunity that any given vaccine can instil on you.”
While some experts have expressed concerns that the Omicron variant of the Covid is better able to evade the current crop of vaccines, Fauci has continued to place his faith in these shots. So too has Pfizer CEO Albert Bourla, though he has claimed that a fourth dose may be needed to combat the new strain.
“With Omicron we need to wait and see because we have very little information. We may need [the fourth dose] faster,” he told CNBC this week.
While Fauci said that an Omicron-specific booster likely won’t be needed, he did add that drug companies like Pfizer “are going to be making variant-specific boosters.”
As interest has increased in the lab leak hypothesis for the origin of the SARS-CoV-2 pandemic it has cast the spotlight upon the behaviours of parts of the scientific community, including the role of peer review, conflicts of interest and the ownership and funding of professional journals. In turn, this can all be considered within national and international political and organisational contexts. ‘Big Pharma’ is also under scrutiny. This article seeks to explain the general nature of the potential threat posed by Big Pharma. It is not a new story. Indeed, it can be usefully discussed with the help of a 60 year-old Presidential address.
On September 5th, 2021, LBC radio host and commentator Maajid Nawaz drew an analogy from Dwight D. Eisenhower’s Farewell Address to the nation as 34th President of the United States on January 17th, 1961. Maajid Nawaz suggested that the threat to democratic society described by President Eisenhower of the ‘Military-Industrial Complex’ has, at least to some degree, been supplanted by a ‘Big Pharma Industrial Complex’. He also suggested that the behaviours of governments in pursuing Covid related policies, such as the vaccination of 12-15 year-olds and vaccine passports (hot topics across the U.K. over the weekend), could only be properly understood by, as he put it, “joining the dots”. He also noted the existence of a “revolving door” of former Government Ministers, MPs and unelected senior officials exiting public office into highly paid commercial positions with large pharmaceutical and similar companies. He suggested that there is, therefore, enormous scope for conflicts of interest to shape public policy in ways that are not to the advantage of the general population.
Maajid Nawaz is correct. It is often worth considering the perspective of a former U.S. President. Their unique position at the apex of both power and information can sometimes result in statements of timeless wisdom and insight. That is irrespective of their party and how we might personally feel about them and their record. President Eisenhower’s Farewell Address has stood the test of time more than most and it deserves attention now. It should be noted that Eisenhower’s Address was made only 16 years after the end of World War Two, at the height of the Cold War with the Soviet Union. It was not an easy time to be president. Despite 60 years having passed the Address still has the ability to send a shiver down the spine. If there was a modern political ‘prophecy’ we would not have wanted to come to pass it was Eisenhower’s. That it did not come true precisely in the manner feared by Eisenhower is ‘good’ but the way it has come true in the last 18 months is probably at least as bad.
The President declared:
Crises there will continue to be. In meeting them, whether foreign or domestic, great or small, there is a recurring temptation to feel that some spectacular and costly action could become the miraculous solution to all current difficulties.
In the context of the SARS-CoV-2 pandemic, the “miraculous solution” was ‘Lockdowns and Vaccines’. Eisenhower continued:
A huge increase in newer elements of our defense; development of unrealistic programs to cure every ill in agriculture; a dramatic expansion in basic and applied research – these and many other possibilities, each possibly promising in itself, may be suggested as the only way to the road we wish to travel.
Eisenhower’s experience as both Supreme Commander of Allied Forces in Europe and as President suggested that mono-solutions were typically hubristic and wrong. There are invariably several roads to choose from. It is for scientists to advise on the possible routes, but it is for politicians to ask questions and to choose the route – to decide what should be done. These are two entirely different things. Eisenhower clearly understood this.
Each proposal must be weighed in the light of a broader consideration: the need to maintain balance in and among national programs – balance between the private and the public economy, balance between cost and hoped for advantage – balance between the clearly necessary and the comfortably desirable; balance between our essential requirements as a nation and the duties imposed by the nation upon the individual; balance between actions of the moment and the national welfare of the future. Good judgment seeks balance and progress; lack of it eventually finds imbalance and frustration.
This could easily have been a useful script for rational governmening during the pandemic. In practice, it was not adopted. The Westminster Government and many others became focussed upon a single dominating issue which, in the absence of balance, let alone a costs-benefits analysis, distorted every element of the political, economic, cultural, health and educational well-being of the nation. No balance. No costs-benefits analysis. Whither “the national welfare of the future”?
Eisenhower was no slouch. As such he considered that the U.S. had hitherto “stood the test” but: “[…] Threats, new in kind or degree, constantly arise. I mention two only.” His “two” were that of the military-industrial complex and the less well known, but similarly important, long term observation that we “cannot mortgage the material assets of our grandchildren without risking the loss also of their political and spiritual heritage”.
The first threat arose because “we can no longer risk emergency improvisation of national defense; we have been compelled to create a permanent armaments industry of vast proportions”. As Maajid Nawaz implied by his reference to the Eisenhower Address, Big Pharma is similarly vast:
“The global pharmaceuticals market is expected to grow from U.S. $1228.45 billion in 2020 to $1250.24 billion in 2021 at a compound annual growth rate (CAGR) of 1.8%.” Major companies include Pfizer, Hoffmann-La Roche; Johnson & Johnson, AstraZeneca, Novartis, GlaxoSmithKline, Bayer, Gilead, Merck and so on. “The market is expected to reach $1700.97 billion in 2025 at a CAGR of 8%.”(“Pharmaceuticals Global Market Report 2021: Covid Impact and Recovery to 2030” – ResearchAndMarkets.com – April 2021 cited here.) It is a large, fast growing sector.
“[…] The global aerospace and defence market is estimated to be valued at U.S. $ 1,600 billion in the year 2025, growing at a CAGR of 3.5% in the period 2019 to 2025.” (“Global Aerospace & Defence Market [(By Region – North America (The U.S. and Mexico), Europe (The U.K., Germany and France) and Asia Pacific (Japan, China & India)] Outlook 2025” – ResearchAndMarkets.com – May 2020 cited here.) It is a large, but maybe not as fast growing, sector when compared to pharmaceuticals.
Just as Eisenhower could say back in 1961: “This conjunction of an immense military establishment and a large arms industry is new in the American experience.” We might say the same of Global Big Pharma. Eisenhower recognised the way in which the military-industrial complex operated: “The total influence – economic, political, even spiritual – is felt in every city, every State house, every office of the Federal government.” Lots of businesses, lots of employees, lots of shareholders (both individual and institutional), lots of lobbying and financing and funding makes influence inevitable. Eisenhower warned: “We recognise the imperative need for this development. Yet we must not fail to comprehend its grave implications. Our toil, resources and livelihood are all involved; so is the very structure of our society.” We should take careful note of his use of the word “grave”. That is this something that can place a nation in danger of serious harm. More specifically:
In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military-industrial complex. The potential for the disastrous rise of misplaced power exists and will persist.
Once more we can see how this might easily occur in the context of Big Pharma, especially as the scientific and knowledge community is so clearly interlinked and operates both alongside and indeed within the responsibilities that modern Governments have taken on in the name of maintaining and improving public health – as broadly defined.
Eisenhower was clearly extremely concerned:
We must never let the weight of this combination endanger our liberties or democratic processes. We should take nothing for granted. Only an alert and knowledgeable citizenry can compel the proper meshing of the huge industrial and military machinery of defense with our peaceful methods and goals, so that security and liberty may prosper together.
We could easily rewrite this as a manifesto for a new movement or political manifesto in 2021:
We must never let the weight of this combination endanger our liberties or democratic processes. We should take nothing for granted. Only an alert and knowledgeable citizenry can compel the proper meshing of the huge Big Pharma machinery and Public Health with our democratic freedoms, so that health, security and liberty may prosper together.
In some ways we would appear to be “too late” given the expansion of overt and covert censorship (including self-censorship) which works against the development of a “knowledgeable citizenry”. And the Government already has a well-established, coercive and divisive, agenda relentlessly traveling towards its “miraculous solution”. But at least it provides a useful perspective. Optimistically: we might consider the miraculous solution (and the supposed end result of ‘safety’) to be a mirage which can ultimately be revealed as such – with the happy ending of ‘the Emperor has no clothes’. Pessimistically: the miraculous solution remains a mirage but compulsory travel towards it becomes, or is deliberately made, ever more difficult to resist. The Emperor does not need clothes – no small boys are allowed to attend the parade.
Eisenhower also noted in his Address that:
Research has become central; it also becomes more formalised, complex, and costly. A steadily increasing share is conducted for, by, or at the direction of, the Federal Government. Today, the solitary inventor, tinkering in his shop, has been overshadowed by task forces of scientists in laboratories and testing fields. In the same fashion, the free university, historically the fountainhead of free ideas and scientific discovery, has experienced a revolution in the conduct of research. Partly because of the huge costs involved, a government contract becomes virtually a substitute for intellectual curiosity. For every old blackboard, there are now hundreds of new electronic computers.
While there are exceptions, this observation can be summed up in practical terms as ‘funding is crucial’. Compromises will inevitably take place to obtain it and retain it. Just as the U.S. Government might always seek to fund a ‘defence application’ as opposed to a peaceful application of new technology in Eisenhower’s day, Big Pharma also has an agenda.
Maajid Nawaz referred to an interesting, and rather damning, piece of research in 2018 by Professor Mariana Mazzucato, Director of the UCL Institute for Innovation and Public Purpose. It was entitled “The People’s Prescription: Re-imagining health innovation to deliver public value“. That report found the process of developing drugs incentivised high prices and the delivery of short-term returns to shareholders. It did not, as a matter of course, adopt higher-risk long-term research into therapeutic advances into diseases such as tuberculosis. In fact, over half of recently (to 2018) approved drugs had little or no extra health care advantage. A cynic would suggest they were tweaks to create new drugs for wealthier markets. A cure for tuberculosis would probably not be particularly remunerative as the market would be far from wealthy. In short, the research suggested that Big Pharma had little genuine interest in improving public health in accordance with actual needs. They do however like to sell lots of drugs to people in rich countries. We should not forget that singular intent.
Pulling the strands of the story together, one comes to the most ominous and portentous part of Eisenhower’s speech:
The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money is ever-present and is gravely to be regarded. Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific-technological elite.
Anyone who has ‘joined the dots’, as Maajid Nawaz suggests we should, from the NIH under Dr. Fauci, allegedly helping to facilitate funding for ‘gain of function’ research on bat coronaviruses at the Wuhan Institute of Virology (making them more transmissible to and between humans) to the labelling of the lab leak hypothesis as a “conspiracy theory” in the Lancet, by a not entirely non-conflicted group of scientists, can see how dangerous this can be to freedom of thought. But as to our “public policy could itself become the captive of a scientific-technological elite”: surely not… our politicians make the public policy decisions so that could never happen… But given all the talk by them of ‘following the Science’ during the pandemic, it apparently has de facto captured public policy. However, this is an illusion as ‘the Science’ is always a bundle of debate. So actually, it appears to be rather more mutually convenient than just a win for the technocrats and Big Pharma. That is especially if we remind ourselves of that revolving door of job opportunities and of what happens when independent science heads in one direction only to meet a politically driven policy miracle heading in the other. The side-lining of the, previously followed, advice from the Joint Commission on Vaccination and Immunisation not to vaccinate 12-15 year-olds in England is a good case in point.
Eisenhower reminds us of something else the pandemic experience has illuminated:
It is the task of statesmanship to mold, to balance, and to integrate these and other forces, new and old, within the principles of our democratic system – ever aiming toward the supreme goals of our free society.
This our politicians, at least in the U.K., have arguably rather failed to do. If there are any statesmen or women in the room please can they make themselves known? It would be good if they could do it quickly. Our free society is being undermined daily, nudge by nudge, new restriction by new restriction, micro-pressure by micro-pressure – albeit naturally for our own safety. And as for our taking out a “mortgage [over] the material assets of our grandchildren” the Westminster Government has truly excelled: “U.K. general Government gross debt was £2,224.5 billion at the end of financial year ending March 2021, equivalent to 106.0% of gross domestic product.” The origin of the word ‘mortgage’ imports debt being likened to ‘the grip of death’. Leaving the last word to Eisenhower: “We want democracy to survive for all generations to come, not to become the insolvent phantom of tomorrow.”
Cephas Alain is the pseudonym of a retired lawyer.
Dr Sebastian Rushworth has written today about the serious problem of the underestimation of side-effects in drug trials, which he says should “shake the very foundations of evidence based medicine”.
His article reports on the results of a study recently published in the Lancet Healthy Longevity, funded by the UK Medical Research Council and the Wellcome Trust, which seeks to establish the extent to which drug trials underestimate side-effects by comparing trial data to real world data. The study focuses in particular on blood pressure drugs known as RAAS blockers, which Dr Rushworth explains were chosen because of the number of trials that have been done by different companies. There is no reason the results should not apply equally to other drugs, he says, including Covid vaccines (for which there have been an unprecedented number of adverse event reports despite the trials showing them to be safe).
The results are shocking. The difference was not marginal but out by a factor of three or four.
The real world patients were between 300% and 400% more likely to experience a serious event than the participants in the trials! That is in spite of the fact that the trials, as mentioned above, were using a broader definition of what constituted a serious event. If the trials were representative of reality, then they should have a higher rate of events than is seen in the real world data. Instead they have a rate that is several times lower!
The difference was just as large in trials specifically involving older people, so age differences can’t be the full explanation, he says (though he allows part of it may be that participants in the trials of older people may be healthier and younger than real world patients).
His main explanation, however, is darker. Are the drug companies simply under-reporting adverse events, both in the drug and placebo treatment groups?
As concerns about the safety of the AstraZeneca vaccine continue to grow and more and more countries move away from it, a comment appeared below the line this morning from “sophie123” that offers insight into the role big pharmaceutical companies are playing in the crisis and the psychology behind the actions of their employees that we thought was worth putting up here.
I work for Big Pharma. I am senior enough to know the executive team pretty well. Some very well.
They are not all good people, by any means – you don’t climb up the greasy pole by being filled with altruism to fellow man. But there’s no overarching evil plot to foist dangerous medicines on people. That is overly simplistic.
What I do see, that has contributed to the situation we are in and I have no doubt is any different at any of the other big pharma companies (execs at which I also know many of):
1) In the UK and US at least, a degree of complicity with what politicians want them to do (because governments ultimately can control pricing, taxes/tax breaks, regulation, all of which impact on stock price, and hand out gongs in the UK). This has many repercussions, and no doubt vaccines that might have been pulled under normal circumstances have continued to be used as a result. Political interference in a space politicians know little about combined with pharma spinelessness in the face of this interference can be very toxic.
2) A desire to be seen as “better” than the other Big Pharma companies. They are not all in cahoots with each other, and some are direct commercial competition. They work on mutual interests together to lobby government (primarily how to stop the US implementing price controls) but there’s as much politicking between CEOs as there is with governments. They mostly hate each other and love it when another company screws up in some way, not necessarily for competitive commercial reasons, but because it makes their failures in the eyes of institutional shareholders look less bad in comparison. But anyway, they’re not some evil cabal cooking up plots to poison the world together. They are superficially cordial but actually all hate one another.
3) Stock price performance is seen as a measure of their success, and it will trump anything else. So any new information that might damage the share price, if it can be stalled or quashed, will be. Only when it’s absolutely necessary will there be a facing of the facts and transparency. Different companies draw the line in different places here. It’s not evil though. I’d liken it to being in denial, like a wife whose husband is working late every night, has a dubious explanation for the lipstick on his collar, denies to herself that anything could be amiss until she catches him and his lover in bed together and can’t ignore it any longer.
The head-in-the-sand approach can be pervasive throughout organisations, especially if there is a “shoot the messenger” culture (which there often is, as like I say, to climb the greasy pole you need to be a bit of an arsehole and shooting messengers is a common enough arsehole trait). So if side effect data start emerging that is not favourable, everybody is hoping and praying it will turn out to be nothing, and start to talk themselves into “it’s nothing”, and only when the evidence becomes incontrovertible is anything done. And then often too slowly. In a good company culture though, the right steps should be taken and personally I have never seen any egregious breaches of appropriate escalation. In the past, that certainly hasn’t always been the case, and many fines have resulted.
4) Boards are lazy. Their oversight is abysmal. They focus on trivialities and processes, rather than ensuring ethics are adhered to. Mostly they are interested in the quality of catering at board meetings and whether someone has printed off their boarding pass for their first class flight home, rather than board matters (they’re largely old, and don’t do electronic boarding cards).
5) Being a pharma industry person does not make you immune to Government/BBC fear tactics, sadly. They are as susceptible to the mainstream narrative as anyone else. Many people don’t seem to have even stopped and thought about this for more than a few minutes, and took the “deadly unprecedented virus to which we are all susceptible” at face value and look at you like you’re smoking something if you dare to suggest it may have been a tiny bit exaggerated.
6) They will only do things that make money, or might make them money in future. They are not charitable organisations. Drug development is risky and expensive, and shareholders want their returns. Sounds obvious, but it underpins everything and people seem to forget that at times.
Stop Press: The Times of Israel is reporting on a leaked Israeli Health Ministry report into the side effects of the Pfizer vaccine that raises “concerns that there could be a link between the second shot and several dozen cases of myocarditis, an inflammation of the heart muscle, particularly in men under 30”. Sixty two cases of myocarditis have been found out of five million vaccinated with two deaths, but no direct link has been established, according to the newspaper. (See more on Lockdown Sceptics.)