The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.
Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.
Here's the underlying premise as succinctly described by author Ben Goldacre:
"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 that 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."
Authors M. Todwin and J. Abramson summarize it thusly:
"Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."
Here is a great list of very recent resources that may convince you of the merits of this concern:
- What doctors don't know about the drugs they prescribe (2012: TED video)
- The drugs don't work: a modern medical scandal (2012: The Guardian)
- Clinical Trial Data as a Public Good (2012: JAMA [subscription req'd])
- Registering Clinical Trial Results. The Next Step (2010: JAMA [subscription req'd])
- The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience (2012: Plos Medicine)
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