The illusion of evidence based medicine
https://www.bmj.com/content/376/bmj.o702
corporate interests,
failed regulation,
and commercialisation of academia,
argue these authors
Jon Jureidini, research leader
Leemon B. McHenry, professor emeritus
Emeritus Professor, Cal State University
Not commissioned, externally peer reviewed
Solid scientific foundation for medicine
Validity of this new paradigm
Reliable data from clinical trials,
Mostly conducted by the pharmaceutical industry
THE JAPANESE JOURNAL OF ANTIBIOTICS
74―1 61( 61 )
Morimasa Yagisawa, Patrick J. Foster, Hideaki Hanaki, Satoshi Ōmura
Kitasato University asked Merck & Co., Inc. to conduct clinical trials of ivermectin for COVID-19 in Japan.
This company has priority to submit an application for an expansion of ivermectin’s indications, since the original approval for the manufacture and sale of ivermectin was conferred to it.
However, the company said that it had no intention of conducting clinical trials.
The release into the public domain of previously confidential pharmaceutical industry documents,
valuable insight into the degree to which industry sponsored clinical trials are misrepresented
Until this problem is corrected, evidence based medicine will remain an illusion
Karl Popper
advocated for the integrity of science and its role in an open, democratic society
A science of real integrity
practitioners are careful not to cling to cherished hypotheses,
and take seriously the outcome of the most stringent experiments
This ideal is, however, threatened by corporations,
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.
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.
Hierarchical power structures, product loyalty,
and public relations propaganda over scientific integrity.
Universities, 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.
The corporate university also compromises the concept of academic leadership.
Deans, (proper academics) 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,
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.
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.”
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.
This uneven playing field is exactly what concerned Popper when he wrote about
Suppression and control of the means of science communication (Popper)
Regulators receive funding from industry,
and use industry funded and performed trials to approve drugs,
without in most cases seeing the raw data.
Drug companies, “mark their own homework”
Our proposals for reforms
liberation of regulators from drug company funding
taxation imposed on pharmaceutical companies to allow public funding of independent trials
anonymised individual patient level trial data posted,
along with study protocols…..