Ben Goldacre, Prof. and found of AllTrials
Michael "Ben" Goldacre, MRCPsych (born 1974) is a British
physician, academic and science writer. As of 2014 he is a Wellcome research
fellow in epidemiology at the London School of
Hygiene and Tropical Medicine. As of March 2015, he is
a Senior Clinical Research Fellow at
for Evidence-Based Medicine, based at Department of Primary Care Health
Sciences at the University
of Oxford. He is a founder of the AllTrials campaign
to require open science practices in clinical trials.
Given the UK system tracks patient and
the drugs they take, opening that information would permit a very inexpensive
way to track side effects and effectiveness of real world treatments.
is known in particular for his "Bad Science" column in The Guardian, and is the author of two
books, The best seller Bad Science (2008),
is a critique of irrationality and certain forms of alternative medicine.
His Bad Pharma (2012), an examination of the pharmaceutical industry, its
publishing and marketing practices, and its relationship with the medical
profession. Goldacre frequently delivers free talks about bad science. His often
starts with missing clinical trials
in explain how the information is distorted (youtube).
Goldacre is the son
of Michael Goldacre, a professor of public health at the University
of Oxford, and the pop singer Susan Traynor, aka Noosha Fox, both of
whom are Australian. Goldacre passed the MRCPsych Part II examinations in December 2005 and became a member of
College of Psychiatrists. He was a research fellow at the Institute
of Psychiatry in London in 2008,[dead
link] and a Guardian
research fellow at Nuffield
College, Oxford, in 2009. As of 2012 he was Wellcome research fellow in epidemiology at
School of Hygiene and Tropical Medicine.
AllTrials (sometimes called All Trials or AllTrials.net)
is a project advocating that clinical
research adopt the
principles of open research.
The project summarizes itself as "All trials registered, all results
reported": that is, all clinical trials should be listed in a clinical trials registry, and their
results should always be shared as open data. At the center of the organisation is a petition signed
by over 85,000 individuals and 599 organisations (as of August
2015). The movement is attempting to persuade the
European Medical Union to legislate a requirement for the raw data from
clinical trials to become available to at least qualified researchers. The current
system of pharma ownership of
trial data entails that peer review in any meaningful sense is not
possible. As a result all industry
funded trials are grossly biased. One
study using the raw data found a 32 percent positive bias when comparing the
raw data to the published journal articles.
This rare glimpse was the result of a group of professors obtain through
the US Freedom of Information Act the raw data submitted to the FDA of phase
iii clinical trials. Some of these
trials resulted in 74 journal articles.
With such freedom, the system of information which doctors rely upon
prevents properly informed choices.
Bad Pharma: How Drug Companies Mislead
Doctors and Harm Patientsis a book by British physician and academic Ben Goldacre about thepharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products.The book was published in September 2012 in the UK by the Fourth Estateimprint of HarperCollins, and in February 2013 in the United States byFaber and Faber.
Goldacre argues in the book that "the whole edifice of medicine is broken" because the evidence on which it is based
is systematically distorted by the pharmaceutical industry. He writes that the industry finances most of theclinical trials into its own products and much of doctors' continuing education, that clinical
trials are often conducted on small groups of unrepresentative subjects and negative data is routinely withheld, and that
apparently independent academic papers may be planned and evenghostwritten by pharmaceutical companies or their contractors, without disclosure. Goldacre calls the situation a "murderous disaster," and makes suggestions
for action by patients' groups, physicians, academics and the industry itself.
From Ben’s book Bad
Pharma: Drugs are tested by the people
who manufacture them, in poorly designed trials, on hopelessly small numbers of
weird, unrepresentative patients, and analysed using techniques which are
flawed by design, in such a way that they exaggerate the benefits of
treatments. Unsurprisingly, these trials tend to produce results that favour
the manufacturer. When trials throw up results that companies don't like, they
are perfectly entitled to hide them from doctors and patients, so we only ever
see a distorted picture of any drug's true effects. Regulators see most of the
trial data, but only from early on in a drug's life, and even then they don't
give this data to doctors or patients, or even to other parts of government.
This distorted evidence is then communicated and applied in a distorted
fashion. In their forty years of practice after leaving medical school, doctors
hear about what works through ad hoc oral traditions, from sales reps,
colleagues or journals. But those colleagues can be in the pay of drug
companies – often undisclosed – and the journals are too. And so are the
patient groups. And finally, academic papers, which everyone thinks of as
objective, are often covertly planned and written by people who work directly
for the companies, without disclosure.
Three Quotes: “A perverse system produces perverse
results.” “We have gone from evidence
based medicine to opinion based medicine with pharma supplying the opinion
makers.” “The devil is in the details.”
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