Monday, March 28, 2022
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
Monday, March 14, 2022
When this pandemic is over, when information about Ivermectin is freely available and when Pfizer vaccine data have been fully released on orders of Judge Mark Pittman, then shall a big scandal explode all over the world.
Monday, February 7, 2022
In 1948 George Orwell warned against Thought Control 100 years hence. We are just 26 years shy of his vision. See it happening in the traditional and social media! Fact-checkers are the arbiters of what we can and cannot express. With no accountability they dare to cast motherhood judgments like "misleading information', "missing context," "false information", etc without proving what is the non-misleading information., what is the proper context, what is true information, etc. Fact-checkers are mostly unidentified and their judgment cannot be appealed.
Friday, February 4, 2022
Omicron is the Natural Vaccine We Failed to Make
Pharma companies and their supporters claim that the
Omicron variant is mild because of the vaccines. They are wrong! Even among the
unvaccinated recent statistics show that the hospitalization and death rates
are very low compared to Delta. Therefore, it is the very nature of Omicron
that makes it mild, not the vaccines.
Omicron is like the Bronze Snake that God instructed
Moses to make when the Israelites (due to their disobedience) were bitten by
snakes in the desert. Anyone who would gaze at the Bronze Snake was healed.
Today, anyone who catches Omicron will have natural immunity. Natural immunity
is far superior to artificial immunity from experimental vaccines. A Ugandan
doctor said that Omicron is “the vaccine that we failed to make.” I believe
that God made and unleashed Omicron to end the pandemic!
Even those with four (4) doses of the vaccines will
catch Omicron. So, why are government officials still bent on vaccinating the
entire population? Now they want to vaccinate kids from 5 to 11 years old whose
immune systems are naturally strong.
What is their motive? Are they racing against time to
beat the expiration dates of the vaccines? Were they promised incentives from
pharma companies which they can use in the upcoming election campaign?
Maybe they are simply naïve, unaware of recent
developments about Covid-19. Maybe they have not reviewed the PSA death statistics
from 2015 to 2021 showing that a mysterious killer claimed 190,000 lives from
March to September 2021 (7 months) while Covid-19 killed 53,000 Filipinos from
March 2020 to January 2022 (23 months). See my earlier post on the matter containing
specific references.
The unfortunate (and I would say immoral) aspect of
such naivete and/or ulterior motives is that the vaccinees will suffer serious
adverse effects including death without reasonable improvement in benefits.
Authorities can approve a measure only when the benefits are greater than the
risks. Recent data show the exact opposite.
Government officials should admit they were wrong. In
lieu of vaccines, vitamins C and D and zinc should be made widely available. They
are cheaper and safer. Vitamin C can come from citrus (orange, lemon); vitamin
D, sunshine from 7 am to 9 am; and zinc, eggs.
The alternative is cheaper and delicious but pharma
companies will not reap profits from them and politicians will not have their
windfall.
February 5,
2022
Sunday, January 30, 2022
Oratio Imperata for protection
against COVID-19
(Revised January 28, 2022)
Merciful and compassionate Father,
we confess our sins
and we humbly come to you
to find forgiveness and life.
We come to you in our need
to seek your protection
against the COVID-19 virus
that has disturbed and claimed many lives.
We ask you now to look upon us with love
and by your healing hand,
dispel the fear of sickness and death,
restore our hope, and strengthen our faith.
We pray that you guide the people
tasked to find cures for this disease
and to stem its transmission.
Bless our efforts
to use the medicines developed
to end the pandemic in our country.
We pray for our health workers
that they may minister to the sick
with competence and compassion.
Grant them health in mind and body,
strength in their commitment,
protection from the disease.
We pray for those afflicted.
May they be restored to health.
Protect those who care for them.
Grant eternal rest to those who have died.
Give us the grace in these trying times
to work for the good of all
and to help those in need.
May our concern and compassion for each
other
see us through this crisis
and lead us to conversion and holiness.
Grant all these
through our Lord Jesus Christ your Son
who lives and reigns with you,
in the unity of the Holy Spirit,
God forever and ever. Amen.
We fly to Your protection,
oh Holy Mother of God.
Do not despise our petition in our necessities, but deliver us always from all
dangers,
oh glorious and blessed Virgin. Amen.
Our Lady, health of the sick, pray for us.
St. Joseph, pray for us.
St. Raphael the Archangel, pray for us.
San Roque, pray for us.
San Lorenzo Ruiz, pray for us.
San Pedro Calungsod, pray for us.
https://cbcpnews.net/cbcpnews/oratio-imperata-against-covid-19/
PS: Observe that this version no longer mentions "vaccines".