by Silviu “Silview” Costinescu

This damning op ed just came out on the most prestigious British Medical Journal (BMJ) and shocked a lot of people.
But, as I’ll show you, there’s been even more shocking and more based research out there pointing the same direction ages ago, and it’s been largely overlooked. So maybe it’s time to stop the awe and start going after the blind sentinels we’re paying to safeguard our body of knowledge that keeps us alive.

Oh my, oh my!
How do these academic fucktards (don’t excuse my accuracy) expect anything “evidence-based” to fare in a post-truth world where men are pregnant and virus isolation is done “in cultures”?! I mean, evidence was an endangered species on Planet Science even before woke science and the macarenavirus…
What can the price of evidence be in an economy where “a patient cured is a customer lost”?!
How do they discover hot water in 2022 and expect to maintain a prestige?!

Whatever the answers may be, we can use this and the references I’ll add after to awaken any NPC that still exhibits signs of intelligent life trapped inside:

The illusion of evidence based medicine

BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o702 (Published 16 March 2022) Cite this as: BMJ 2022;376:o702

1. Jon Jureidini, research leader1,  
2. Leemon B. McHenry, professor emeritus2

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors

The advent of evidence based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented.1234 Until this problem is corrected, evidence based medicine will remain an illusion.

The philosophy of critical rationalism, advanced by the philosopher Karl Popper, famously advocated for the integrity of science and its role in an open, democratic society. A science of real integrity would be one in which practitioners are careful not to cling to cherished hypotheses and take seriously the outcome of the most stringent experiments.5 This ideal is, however, threatened by corporations, in which financial interests trump the common good. 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.6 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.7 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.”

Ironically, industry sponsored KOLs appear to enjoy many of the advantages of academic freedom, supported as they are by their universities, the industry, and journal editors for expressing their views, even when those views are incongruent with the real evidence. While universities fail to correct misrepresentations of the science from such collaborations, critics of industry face rejections from journals, legal threats, and the potential destruction of their careers.8 This uneven playing field is exactly what concerned Popper when he wrote about suppression and control of the means of science communication.9 The preservation of institutions designed to further scientific objectivity and impartiality (i.e., public laboratories, independent scientific periodicals and congresses) is entirely at the mercy of political and commercial power; vested interest will always override the rationality of evidence.10

Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.

Our proposals for reforms include: liberation of regulators from drug company funding; taxation imposed on pharmaceutical companies to allow public funding of independent trials; and, perhaps most importantly, anonymised individual patient level trial data posted, along with study protocols, on suitably accessible websites so that third parties, self-nominated or commissioned by health technology agencies, could rigorously evaluate the methodology and trial results. With the necessary changes to trial consent forms, participants could require trialists to make the data freely available. The open and transparent publication of data are in keeping with our moral obligation to trial participants—real people who have been involved in risky treatment and have a right to expect that the results of their participation will be used in keeping with principles of scientific rigour. Industry concerns about privacy and intellectual property rights should not hold sway.

Footnotes

• Competing interests: McHenry and Jureidini are joint authors of The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research (Adelaide: Wakefield Press, 2020). Both authors have been remunerated by Los Angeles law firm, Baum, Hedlund, Aristei and Goldman for a fraction of the work they have done in analysing and critiquing GlaxoSmithKline’s paroxetine Study 329 and Forest Laboratories citalopram Study CIT-MD-18. They have no other competing interests to declare.
• Provenance and peer review: Not commissioned, externally peer reviewed

References

1. ↵
   1. Steinman MA, 
   2. Bero LA, 
   3. Chren MM, 
   4. Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med2006;145:284-93. doi:10.7326/0003-4819-145-4-200608150-00008 pmid:16908919CrossRef PubMed Web of Science Google Scholar
2. ↵
   1. Mukherjee D, 
   2. Nissen SE, 
   3. Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA2001;286:954-9. doi:10.1001/jama.286.8.954. pmid:11509060 CrossRef PubMed Web of Science Google Scholar
3. ↵
   1. Doshi P. Pandemrix vaccine: why was the public not told of early warning signs?BMJ2018;362:k3948doi:10.1136/bmj.k3948. FREE Full Text Google Scholar
4. ↵
   1. Jureidini J, 
   2. McHenry L, 
   3. Mansfield P. Clinical trials and drug promotion: Selective reporting of Study 329. Int J Risk Saf Med2008;20:73-81doi:10.3233/JRS-2008-0426. CrossRef Google Scholar
5. ↵
   1. Popper K. The Logic of Scientific Discovery.Basic Books, 1959. Google Scholar
6. ↵
   1. Bok D. Universities in the Marketplace: The Commercialization of Higher Education.Princeton University Press, 2003.Google Scholar
7. ↵IntraMed. Criteria Used to Develop Influence Score. 2008. https://www.industrydocumentslibrary.ucsf.edu/drug/docs/#id=shbn0225
8. ↵Schafer A. Biomedical conflicts of interest: A defense of the sequestration thesis—Learning from the cases of Nancy Olivieri and David Healy. Journal of Medical Ethics. 2004;30:8-24.
9. ↵
   1. Popper K. The Poverty of Historicism. Routledge, 1961: 154-5. Google Scholar
10. ↵
    1. Howick J. Exploring the asymmetrical relationship between the power of finance bias and evidence. Perspect Biol Med2019;62:159-87. doi:10.1353/pbm.2019.0009 pmid:31031303 CrossRef PubMed Google Scholar

As you can see, their references range mostly from classical to old. Experienced tinfoil hats must already be yawning by now, but they’re not the primary target for this piece.

Here are some really good comments on this from Bret Weinstein:

Now let me provide some more reading recommendations along this line.

The very same BMJ, almost 10 years ago:

Education And Debate

Who pays for the pizza? Redefining the relationships between doctors and drug companies –

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7400.1189 (Published 29 May 2003)

“Twisted together like the snake and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous (box). As national drug bills rise at rates that vastly exceed those of inflation (fig 1), this entanglement and the subsequent flows of money and influence are attracting increasing public and academic scrutiny.

Studies from several countries show that 80-95% of doctors regularly see drug company representatives despite evidence that their information is overly positive and prescribing habits are less appropriate as a result.1 2 Many doctors receive multiple gifts from drug companies every year, and most doctors deny their influence despite considerable evidence to the contrary.3 Industry interactions correlate with doctors’ preferences for new products that hold no demonstrated advantage over existing ones, a decrease in the prescribing of generics, and a rise in both prescription expenditures and irrational and incautious prescribing, according to a recent analysis of the ethics of gift giving.4 The number of gifts that doctors receive correlates with beliefs that drug representatives have no impact on prescribing behaviour.3

Accepting meals and expenses for travel or accommodation for sponsored educational meetings is common despite evidence that this is associated with an increase in formulary requests for and prescribing of the sponsor’s drug.2 3 Most doctors attend company sponsored events providing continuing medical education, 2 yet evidence shows that these preferentially high-light the sponsor’s drug.3 Many professional societies rely heavily on industry sponsorship, …”

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

Journal of Law, Medicine and Ethics, 2013, Vol. 14, No. 3: 590-610, Posted: 20 Jun 2013 Last revised: 11 Apr 2020

Donald W. Light – Rowan University School of Osteopathic Medicine ; Center for Migration and Development; Institute for Advanced Study

Joel Lexchin – York University

Jonathan J. Darrow = Harvard Medical School

Date Written: June 1, 2013

Abstract

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.

Most scientists ‘can’t replicate studies by their peers’

BBC, 22 February 2017

Science is facing a “reproducibility crisis” where more than two-thirds of researchers have tried and failed to reproduce another scientist’s experiments, research suggests.

This is frustrating clinicians and drug developers who want solid foundations of pre-clinical research to build upon.

From his lab at the University of Virginia’s Centre for Open Science, immunologist Dr Tim Errington runs The Reproducibility Project, which attempted to repeat the findings reported in five landmark cancer studies.

“The idea here is to take a bunch of experiments and to try and do the exact same thing to see if we can get the same results.”

You could be forgiven for thinking that should be easy. Experiments are supposed to be replicable.

The authors should have done it themselves before publication, and all you have to do is read the methods section in the paper and follow the instructions.

Sadly nothing, it seems, could be further from the truth.

After meticulous research involving painstaking attention to detail over several years (the project was launched in 2011), the team was able to confirm only two of the original studies’ findings.

Two more proved inconclusive and in the fifth, the team completely failed to replicate the result.

“It’s worrying because replication is supposed to be a hallmark of scientific integrity,” says Dr Errington.

Concern over the reliability of the results published in scientific literature has been growing for some time.

According to a survey published in the journal Nature last summer, more than 70% of researchers have tried and failed to reproduce another scientist’s experiments.

Marcus Munafo is one of them. Now professor of biological psychology at Bristol University, he almost gave up on a career in science when, as a PhD student, he failed to reproduce a textbook study on anxiety.

“I had a crisis of confidence. I thought maybe it’s me, maybe I didn’t run my study well, maybe I’m not cut out to be a scientist.”

The problem, it turned out, was not with Marcus Munafo’s science, but with the way the scientific literature had been “tidied up” to present a much clearer, more robust outcome.

“What we see in the published literature is a highly curated version of what’s actually happened,” he says.

“The trouble is that gives you a rose-tinted view of the evidence because the results that get published tend to be the most interesting, the most exciting, novel, eye-catching, unexpected results.

“What I think of as high-risk, high-return results.”

The reproducibility difficulties are not about fraud, according to Dame Ottoline Leyser, director of the Sainsbury Laboratory at the University of Cambridge.

That would be relatively easy to stamp out. Instead, she says: “It’s about a culture that promotes impact over substance, flashy findings over the dull, confirmatory work that most of science is about.”

She says it’s about the funding bodies that want to secure the biggest bang for their bucks, the peer review journals that vie to publish the most exciting breakthroughs, the institutes and universities that measure success in grants won and papers published and the ambition of the researchers themselves.

“Everyone has to take a share of the blame,” she argues. “The way the system is set up encourages less than optimal outcomes.”

For its part, the journal Nature is taking steps to address the problem.

It’s introduced a reproducibility checklist for submitting authors, designed to improve reliability and rigour.

“Replication is something scientists should be thinking about before they write the paper,” says Ritu Dhand, the editorial director at Nature.

“It is a big problem, but it’s something the journals can’t tackle on their own. It’s going to take a multi-pronged approach involving funders, the institutes, the journals and the researchers.”

But we need to be bolder, according to the Edinburgh neuroscientist Prof Malcolm Macleod.

“The issue of replication goes to the heart of the scientific process.”

Writing in the latest edition of Nature, he outlines a new approach to animal studies that calls for independent, statistically rigorous confirmation of a paper’s central hypothesis before publication.

“Without efforts to reproduce the findings of others, we don’t know if the facts out there actually represent what’s happening in biology or not.”

Without knowing whether the published scientific literature is built on solid foundations or sand, he argues, we’re wasting both time and money.

“It could be that we would be much further forward in terms of developing new cures and treatments. It’s a regrettable situation, but I’m afraid that’s the situation we find ourselves in.”

“UP TO 90% OF THE PUBLISHED MEDICAL INFORMATION IS FLAWED” – PSYCHOLOGY TODAY

“Can any medical research studies be trusted?” – Psychology Today

Why Has the Number of Scientific Retractions Increased?

• Published: July 8, 2013
• https://doi.org/10.1371/journal.pone.0068397

Abstract

Background

The number of retracted scientific publications has risen sharply, but it is unclear whether this reflects an increase in publication of flawed articles or an increase in the rate at which flawed articles are withdrawn.

Methods and Findings

We examined the interval between publication and retraction for 2,047 retracted articles indexed in PubMed. Time-to-retraction (from publication of article to publication of retraction) averaged 32.91 months. Among 714 retracted articles published in or before 2002, retraction required 49.82 months; among 1,333 retracted articles published after 2002, retraction required 23.82 months (p<0.0001). This suggests that journals are retracting papers more quickly than in the past, although recent articles requiring retraction may not have been recognized yet. To test the hypothesis that time-to-retraction is shorter for articles that receive careful scrutiny, time-to-retraction was correlated with journal impact factor (IF). Time-to-retraction was significantly shorter for high-IF journals, but only ∼1% of the variance in time-to-retraction was explained by increased scrutiny. The first article retracted for plagiarism was published in 1979 and the first for duplicate publication in 1990, showing that articles are now retracted for reasons not cited in the past. The proportional impact of authors with multiple retractions was greater in 1972–1992 than in the current era (p<0.001). From 1972–1992, 46.0% of retracted papers were written by authors with a single retraction; from 1993 to 2012, 63.1% of retracted papers were written by single-retraction authors (p<0.001).

Conclusions

The increase in retracted articles appears to reflect changes in the behavior of both authors and institutions. Lower barriers to publication of flawed articles are seen in the increase in number and proportion of retractions by authors with a single retraction. Lower barriers to retraction are apparent in an increase in retraction for “new” offenses such as plagiarism and a decrease in the time-to-retraction of flawed work.

Misconduct accounts for the majority of retracted scientific publications

Ferric C. Fang, R. Grant Steen, and Arturo Casadevall arturo.casadevall@einstein.yu.edu

October 1, 2012 | 109 (42) 17028-17033 | https://doi.org/10.1073/pnas.1212247109

Abstract

A detailed review of all 2,047 biomedical and life-science research articles indexed by PubMed as retracted on May 3, 2012 revealed that only 21.3% of retractions were attributable to error. In contrast, 67.4% of retractions were attributable to misconduct, including fraud or suspected fraud (43.4%), duplicate publication (14.2%), and plagiarism (9.8%). Incomplete, uninformative or misleading retraction announcements have led to a previous underestimation of the role of fraud in the ongoing retraction epidemic. The percentage of scientific articles retracted because of fraud has increased ∼10-fold since 1975. Retractions exhibit distinctive temporal and geographic patterns that may reveal underlying causes.

The number and frequency of retracted publications are important indicators of the health of the scientific enterprise, because retracted articles represent unequivocal evidence of project failure, irrespective of the cause. Hence, retractions are worthy of rigorous and systematic study. The retraction of flawed publications corrects the scientific literature and also provides insights into the scientific process. However, the rising frequency of retractions has recently elicited concern (1, 2). Studies of selected retracted articles have suggested that error is more common than fraud as a cause of retraction (3–5) and that rates of retraction correlate with journal-impact factor (6). We undertook a comprehensive analysis of all retracted articles indexed by PubMed to ascertain the validity of the earlier findings. Retracted articles were classified according to whether the cause of retraction was documented fraud (data falsification or fabrication), suspected fraud, plagiarism, duplicate publication, error, unknown, or other reasons (e.g., journal error, authorship dispute).

Retracted scientific paper persists in new citations, study finds – Illinois University, JAN 5, 2021

“Pharmaceutical companies often manipulate the word innovation for rhetorical purposes and seldom develop clinically superior drugs, thus corrupting the R&D process. He cited studies indicating that over the past 30 years, on average fewer than 2 major clinical advances and 7-13 superior drugs were developed each year, compared with the 85-90 drugs that are developed with few or no advantages. With 113,000 deaths a year caused by adverse drug reactions just in hospitalized patients and 2.5 million serious reactions, Professor Light believes there is an epidemic of harmful side effects from drugs that often have few offsetting advantages.”

“The Pharmaceutical Industry, Institutional Corruption, and an Epidemic of Harms” – Donald Light Harvard seminar

Conflicts of Interest as a Health Policy Problem: Industry Ties and Bias in Drug Approval – Harvard University 2014

“A staggering 94% of surveyed physicians acknowledged receiving financial compensation of some form from pharmaceutical companies, ranging from small perks such as free gifts and meals to stipendiary speaking invitations and salaried positions as industry consultants.”

Drug Companies and Medicine: What Money Can Buy – Harvard University, 2009

The Haunting of Medical Journals: How Ghostwriting Sold “HRT”

• Adriane J. Fugh-Berman 
• Published: September 7, 2010
• https://doi.org/10.1371/journal.pmed.1000335

Summary Points

• Some 1500 documents revealed in litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.
• Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.
• Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.
• Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.

Introduction

In recent litigation against Wyeth, more than 14,000 plaintiffs brought claims related to the development of breast cancer while taking the menopausal hormone therapy Prempro (conjugated equine estrogens [CEEs] and medroxyprogesterone acetate [MPA]). Some 1500 documents revealed in the litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals. These documents became public when PLoS Medicine and The New York Times intervened in the litigation. Both intervenors successfully argued that ghostwriting undermines public health and that documents proving the practice should be unsealed.

In this Policy Forum article, I use these documents, which are available through PLoS at http://www.plosmedicine.org/static/ghostwriting.action or at the Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp to show how industry uses ghostwriters to insert marketing messages into articles published in medical journals. As a paid expert witness, I had access to these documents during the litigation but I have received no payment for researching or writing this Policy Forum.

Hormone Therapy History

In 1942, Premarin (CEE) became the first FDA-approved treatment for hot flashes. Promotional efforts implied that estrogen could preserve youth and health. By the early 1970s, physicians, under the mistaken impression that menopause was an endocrine disease similar to hypothyroidism, were prescribing estrogen to millions of asymptomatic women. In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use, and estrogen sales decreased [1].

After adding a progestin pill to counteract estrogen-induced endometrial cancer, hormone “replacement” therapy (HRT; now properly termed menopausal hormone therapy, or HT) became popular in the 1980s. Through the 1990s, HT was touted to prevent cardiovascular disease, osteoporosis, Alzheimer’s disease, colon cancer, tooth loss, and macular degeneration [1]. Prempro, which combined CEE and the progestin Provera (medroxyprogesterone acetate), was approved in the U.S. in 1995. In 1998, the Heart and Estrogen/progestin Replacement Study (HERS), a randomized controlled trial (RCT) in women with cardiovascular disease, found no benefit of HT for preventing cardiovascular events [2]. In 2002, the Women’s Health Initiative (WHI), a large RCT in healthy women, demonstrated conclusively that HT failed to prevent cardiovascular disease, increased the risk of breast cancer and stroke, and reduced fracture risk [3],[4]. Later analyses revealed that HT increased the risk of dementia [5] and incontinence [6].

Today, despite definitive scientific data to the contrary, many gynecologists still believe that the benefits of HT outweigh the risks in asymptomatic women [1],[7]–[8]. This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.

To be continued?
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