From the British Medical Journal:
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
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
No comments:
Post a Comment