Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, February 4, 2013

Ben Goldacre: Debunker!

By BEN GOLDACRE   FiDA highlight
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 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 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.

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.””

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