Experts Concede It’s an Illusion
Evidence-Based Medicine is an illusion
A patient cured is a patient lost
Oh my, how can we expect anything to be “evidence-based” in a post-truth world where even basic scientific facts are denied? The scarcity of evidence in the scientific community was already a problem before the rise of woke science and the pandemic.In today’s economy, where “a patient cured is a customer lost,” what is the true cost of evidence? How can experts continue to maintain their prestige while discovering what is already known Regardless, we can use this information, along with the references I will provide, to educate and awaken anyone who may still exhibit intelligent thought.
Intro
A recently published op-ed in the prestigious British Medical Journal (BMJ) has garnered significant attention for its damning findings. However, there have been previous studies with even more shocking and well-founded research pointing in the same direction for a long time, yet they have largely been ignored. It may be time to move beyond mere admiration and hold accountable those who are entrusted with protecting our life-saving body of knowledge.
The truth
In a recent publication on BMJ, research leader Jon Jureidini and professor emeritus Leemon B. McHenry argue that evidence-based medicine has been compromised by corporate interests, deficient regulation, and the commercialization of academia. The authors provide compelling evidence that the scientific process has been subverted by vested interests, putting profits over patient care. This is a wake-up call for the medical community and the public to demand transparency and accountability in the pursuit of unbiased evidence-based medical practices. (Source: https://doi.org/10.1136/bmj.o702)
The Publication
“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"
The current system allows regulators to approve drugs based on industry-funded trials without access to the raw data, while also receiving funding from industry. This raises serious doubts about the reliability and independence of the regulatory process. It is concerning that drug companies can essentially “mark their own homework” instead of being subject to independent scrutiny as part of a public regulatory system. Unfortunately, governments and regulators seem unwilling to initiate the necessary changes to remove industry influence from research and clean up publishing models that rely 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.”
My take
The medical community has gained valuable insight into the degree to which industry-sponsored clinical trials are misrepresented, thanks to the release of previously confidential pharmaceutical industry documents. However, evidence-based medicine will remain an illusion until this problem is corrected. Clinical trials are predominantly conducted by the pharmaceutical industry and reported in the names of senior academics. This raises questions about the validity of evidence-based medicine, which was intended to provide a solid scientific foundation for medicine. The problem lies in the fact that evidence-based medicine relies on reliable data from clinical trials, most of which are conducted and sponsored by the pharmaceutical industry. In addition, regulators receive funding from the industry and use industry-funded and performed trials to approve drugs, without seeing the raw data in most cases. As a result, drug companies are effectively allowed to “mark their own homework” instead of having their products tested by independent experts as part of a public regulatory system. The lack of concern from governments and captured regulators means that they are unlikely to initiate necessary changes to remove research from the industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.
References:
- Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145(4):284–93. doi: 10.7326/0003–4819–145–4–200608150–00008. PMID: 16908919
- Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286(8):954–9. doi: 10.1001/jama.286.8.954. PMID: 11509060
- Doshi P. Pandemrix vaccine: why was the public not told of early warning signs? BMJ. 2018;362:k3948. doi: 10.1136/bmj.k3948.
- Jureidini J, McHenry L, Mansfield P. Clinical trials and drug promotion: Selective reporting of Study 329. Int J Risk Saf Med. 2008;20(2):73–81. doi: 10.3233/JRS-2008–0426.
- Popper K. The Logic of Scientific Discovery. Basic Books, 1959.
- Bok D. Universities in the Marketplace: The Commercialization of Higher Education. Princeton University Press, 2003.
- IntraMed. Criteria Used to Develop Influence Score. 2008. https://www.industrydocumentslibrary.ucsf.edu/drug/docs/#id=shbn0225
- 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.
- Popper K. The Poverty of Historicism. Routledge, 1961: 154–5.
- Howick J. Exploring the asymmetrical relationship between the power of finance bias and evidence. Perspect Biol Med. 2019;62(2):159–87. doi: 10.1353/pbm.2019.0009. PMID: 31031303.
The references used by the authors of the BMJ article are largely historical, but this does not diminish their relevance or importance in understanding the issue at hand. It is essential to analyze the foundations of evidence-based medicine and its evolution over time to identify where and how it has been corrupted by corporate interests.
Instead of dismissing the references as outdated, we should recognize the wisdom of past thinkers and experts and use their work to inform current discussions and debates.
Here is Bret Weinstein’s take:
Here are some additional resources that delve deeper into the same topic:
Nearly a decade ago, the BMJ published an article titled “Education and Debate: The Corruption of Evidence Based Medicine” that further explores the issues surrounding evidence-based medicine and corporate influence.
The article can be found here: https://www.bmj.com/content/337/bmj.a632
Additionally, the Cochrane Collaboration, a respected organization that produces systematic reviews of healthcare interventions, has been vocal about the impact of commercial and financial interests on the integrity of clinical trials and evidence-based medicine.
More information can be found on their website: https://www.cochrane.org/about-us/evidence-based-health-care-and-systematic-reviews
Redefined 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, …”
The Myth of Safe and Effective Drugs: Examining Institutional Corruption in Pharmaceuticals
Journal of Law, Medicine and Ethics, 2013, Vol. 14, №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
MOST SCIENTISTS ‘CAN’T REPLICATE STUDIES BY THEIR PEERS’
BBC, 22 February 2017
According to research, science is experiencing a “reproducibility crisis” in which over two-thirds of researchers have attempted and failed to replicate experiments conducted by other scientists.
The field of science is facing a challenge known as the “reproducibility crisis,” where over two-thirds of researchers have attempted and failed to replicate other scientists’ experiments, leading to frustration among clinicians and drug developers who seek reliable pre-clinical research. Immunologist Dr. Tim Errington, who runs The Reproducibility Project from the University of Virginia’s Centre for Open Science, led an effort to replicate five landmark cancer studies, but his team was only able to confirm two of the original studies’ findings. Two of the studies proved inconclusive, and in the fifth, the team was unable to replicate the result at all. This finding is troubling because replication is supposed to be a hallmark of scientific integrity. The problem of the reliability of the published scientific literature’s results has been growing for some time, with more than 70% of researchers surveyed in a journal Nature publication stating that they have failed to reproduce another scientist’s experiments. The issue is not due to fraud but rather a culture that prioritizes flashy and unexpected results over substance and confirms the view that replication is supposed to be a hallmark of scientific integrity. Everyone is to blame, from funding bodies to peer review journals to universities, which have an impact on the way the system is set up, encouraging suboptimal outcomes.
Flaws in Published Medical Information: Psychology Today Report
“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
Findings and methods
We analyzed 2,047 retracted articles indexed in PubMed to investigate the time interval between publication and retraction. The average time-to-retraction (from the publication of the article to the publication of the retraction) was 32.91 months. For 714 retracted articles published on or before 2002, retraction required 49.82 months, while for 1,333 retracted articles published after 2002, retraction required 23.82 months (p<0.0001). This indicates that journals are retracting papers more promptly than in the past, although recent articles needing retraction may not have been identified yet. We tested the hypothesis that time-to-retraction is shorter for articles that receive careful scrutiny by correlating time-to-retraction with journal impact factor (IF). Time-to-retraction was significantly shorter for high-IF journals, but only about 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, indicating that articles are now retracted for reasons not cited in the past. In 1972–1992, authors with multiple retractions had a greater proportional impact than in the current era (p<0.001). From 1972–1992, 46.0% of retracted papers were authored by those with a single retraction, whereas from 1993 to 2012, 63.1% of retracted papers were authored by single-retraction authors (p<0.001).
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
An in-depth examination of all 2,047 biomedical and life science research articles listed on PubMed as retracted on May 3, 2012 revealed that only 21.3% of retractions were due to errors, while 67.4% were due to misconduct such as fraud or suspected fraud (43.4%), duplicate publication (14.2%), and plagiarism (9.8%). In the past, incomplete, uninformative, or misleading retractions have led to an underestimation of the role of fraud in the ongoing retraction epidemic. The percentage of scientific articles retracted because of fraud has increased by approximately 10 times since 1975. The temporal and geographic patterns of retractions may provide insights into their underlying causes.
Retracted publications are clear indicators of project failure regardless of the reason, making their number and frequency essential measures of the scientific enterprise’s health. Therefore, they are worthy of rigorous and systematic study. While earlier studies of selected retracted articles have suggested that errors are more common than fraud as a cause of retraction and that journal impact factor correlates with retraction rates, our comprehensive analysis of all retracted articles indexed by PubMed aimed to verify these findings. Retracted articles were categorized based on the documented cause of retraction, such as fraud, 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.”
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
