http://nyti.ms/XePMa8
By BEN GOLDACRE FiDA highlight
NEW YORK TIMES OP-ED CONTRIBUTOR
Published: February 1, 2013
THIS
month, Johnson & Johnson is facing more than 10,000 lawsuits over an artificial hip that
has been recalled because of a 40 percent failure rate within five years. Mistakes
happen in medicine, but internal documents showed that executives had known of
flaws with the device for some time, but had failed to make them public.
It would be nice to imagine that this kind of
behavior is exceptional, but in reality, the entire evidence base for medicine has been undermined
by a casual lack of transparency. Sometimes this is through a failure to
report concerns raised by doctors and internal analyses, as was the case with
Johnson & Johnson. More
commonly, it involves the suppression of clinical trial results,
especially when they show a drug is no good. These problems would be bad enough
on their own, but they are compounded
by a generation of “fake fixes” that have delivered false reassurance, and so
prevent realistic public discussion.
The best evidence shows that half of all the
clinical trials ever conducted and completed on the treatments in use today
have never been published in academic journals. Trials with positive or flattering results,
unsurprisingly, are about twice as likely to be published — and this is
true for both academic research and industry studies.
If I toss
a coin, but hide the result every time it comes up tails, it looks as if I
always throw heads. You wouldn’t tolerate that if we were choosing
who should go first in a game of pocket billiards, but in medicine, it’s accepted as the norm. In
the worst case, we can be misled into believing that ineffective treatments are
worth using; more commonly we are misled about the relative merits of competing
treatments, exposing patients to inferior ones.
This problem has been documented for three
decades, and many in the industry now claim it has been fixed. But every
intervention has been full of loopholes, none has been competently implemented
and, lastly, with no
routine public audit, flaws have taken years to emerge.
The Food and Drug Administration Amendments Act of 2007 is
the most widely cited fix. It required that new clinical trials conducted in
the United States post summaries of their results at clinicaltrials.gov within a year
of completion, or face a fine of $10,000 a day. But in 2012, the British Medical
Journal published the first open
audit of the process, which found that four out of five trials
covered by the legislation had ignored the reporting requirements. Amazingly,
no fine has yet been levied.
An earlier fake fix dates from 2005, when the
International Committee of Medical Journal Editors made an
announcement: their members would never again publish any
clinical trial unless its existence had been declared on a publicly accessible
registry before the trial began. The reasoning was simple: if everyone
registered their trials at the beginning, we could easily spot which results
were withheld; and since everyone wants to publish in prominent academic
journals, these editors had the perfect carrot. Once again, everyone assumed
the problem had been fixed.
But four years later we discovered, in a paper from The Journal of the American Medical Association,
that the editors had broken their promise: more than half of all trials
published in leading journals still weren’t properly registered, and a quarter
weren’t registered at all.
Even if these fixes had been successful, we would
still be decades away from knowing the full truth about our medical treatments,
because today’s decisions are informed by the trials of the past, on drugs that
were first researched and approved in 2007, 2002, 1998 and earlier. None of the
reforms has even tried to ensure public access for these results, and so they
remain buried in dry storage archives, deep underground.
All of these problems are perhaps best
illustrated by the case of Tamiflu, which governments have spent billions of
dollars stockpiling, in the belief that the drug will reduce the rate of
complications from influenza. But roughly half the trial results have never
been published, and researchers trying to obtain the full Clinical Study
Reports have been stonewalled by the manufacturer, Roche.
This cannot be acceptable. Withholding data not
only misleads doctors and patients; it’s an insult to the patients who have
participated in clinical trials, believing that they were helping to improve
medical knowledge.
Medicine routinely overcomes enormous technical
challenges, and there is
nothing complicated about the changes needed to prevent Johnson &
Johnson, or Roche — or anybody — from withholding information. The F.D.A. has proposed reforms to its systems for assessing
artificial hips. And a campaign, supported by the National Physicians Alliance,
has begun at alltrials.net demanding that results be
publicly reported for all trials, dating back to at least the 1990s, on all
treatments currently in use. We need competent legislation, enforcement and
leadership from medical academic bodies, all clearly stating that nonpublication
of trial results is nothing less than research misconduct.
This will take place against a clamor from industry stakeholders.
They have worked hard to silence discussion on these problems, by pretending
that the flaws have already been fixed. Why? Because this strategy is their
only hope. There is no
defense for withholding information on treatments used by patients around the
world.
Ben Goldacre, a doctor, is the author of
“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients.”
@bengoldacre (Twitter)
A version of this op-ed appeared in print on February
2, 2013, on page A23 of the New York edition with the headline: Health Care’s
Trick Coin.
http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html
Speakers Ben
Goldacre: Debunker
Ben Goldacre unpicks dodgy scientific claims made
by scaremongering journalists, dubious government reports, pharmaceutical
corporations, PR companies and quacks.
Why you should listen to him:
"It was the MMR story that finally made me crack,"
begins the Bad Science manifesto, referring to the sensationalized -- and
now-refuted -- link between vaccines and autism. With that sentence Ben
Goldacre fired the starting shot of a crusade waged from the pages of The
Guardian from 2003 to 2011, on an addicitve Twitter feed, and in bestselling books, including Bad Science and his latest, Bad Pharma, which puts
the $600 billion global pharmaceutical industry under the microscope. What he
reveals is a fascinating, terrifying mess.
Goldacre was trained in medicine
at Oxford and London, and works as an academic in epidemiology. Helped along by
this inexhaustible supply of material, he also travels the speaking circuit,
promoting skepticism and nerdish curiosity with fire, wit, fast delivery and a
lovable kind of exasperation. (He might even convince you that real science,
sober reporting and reason are going to win in the end.)
As he writes, "If you're a journalist who misrepresents
science for the sake of a headline, a politician more interested in spin than
evidence, or an advertiser who loves pictures of molecules in little white
coats, then beware: your days are numbered."
"There
aren't many out-and-out good eggs in British journalism but Ben Goldacre is one
of them."
Ed Lake, The Daily Telegraph
Quotes by Ben Goldacre
““Real
science is all about critically appraising the evidence for somebody else’s
position.”
” Watch this talk »
““The
placebo effect is one of the most fascinating things in the whole of medicine.
It’s not just about taking a pill, and your performance and your pain getting
better. It’s about our beliefs and expectations. It’s about the cultural
meaning of a treatment.”
” Watch this talk »
““Positive findings are around
twice as likely to be published as negative findings. This is a cancer at the
core of evidence-based medicine.”
” Watch this talk »
““[In
science,] we only hear about the flukes and about the freaks.””
http://www.ted.com/talks/ben_goldacre_battling_bad_science.html
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