I agree Harry. It will be a struggle to make it happen, but it's worth a struggle I think. Here's another story...
Trials and transparency
May 19th 2006 - The Economist - WITHOUT clinical trials, there would be no new miracle drugs. Pharmaceutical researchers could not test the efficacy, safety or anything much else about potential new treatments. So it is a pity that drug trials are under a cloud thanks to several recent scandals.
In Britain a recent early-stage trial of TGN1412, a monoclonal antibody designed to treat leukaemia, went horribly wrong; half a dozen patients were left gravely ill with multiple organ failure. Elsewhere, critics accuse Merck of withholding data from trials of Vioxx, a painkiller, that suggest it causes a higher risk of heart problems. In New York, Eliot Spitzer, the attorney general, has accused GlaxoSmithKline of suppressing data indicating that Paxil, an anti-depressant, might increase the risk of suicide in some children. The ordinary punter can be forgiven for thinking that a process designed to get at the truth is being manipulated by drug firms.
Happily, the World Health Organisation (WHO) thinks it has a solution. In an article in this week's Lancet, the agency unveils the results of its two-year-long effort to forge a set of universal rules for disclosing data from clinical trials. At the moment, the industry can choose from various voluntary initiatives encouraging disclosure and dozens of registries, but it is governed by few hard-and-fast rules.
With its new manifesto, the WHO hopes to change all that. It outlines 20 data requirements that must be disclosed for all trials. Provocatively, it insists that all such information must be disclosed before the first patient is registered for a trial—even for early-stage trials.
This is unlikely to sit well with the pharmaceutical industry. Caroline Loew of PhRMA, the American drug industry's lobbying arm, argues that disclosing details such as an experimental compound's proper scientific name could tip-off rival researchers that a firm has found a novel dosing regimen or a new use for an old compound. That, argues Dr Loew, would deter innovation and lead to drug companies looking for new treatments using rivals' data rather than their own research. If so, the lobbyists mutter, it would be the death of the industry.
The fears are overblown. Full disclosure early in trials might indeed make it harder for firms to protect clever new ideas. But pharmaceutical companies should still enjoy patent protection. In any case, they already routinely look for clues as to what their rivals are doing. The WHO argues that transparency could even improve the efficiency of the drug discovery process. The same firm that loses its lead on one drug might catch up or beat rivals on three others using information gained from a newly transparent process.
Sidney Wolfe of Public Citizen, an American watchdog group, even argues that these new recommendations do not go far enough. Voluntary measures will always fail, he says, because “the ones that have the most to hide will be the ones that disclose the least.” This bias toward publishing only positive research, he argues, has led to the suppression of valuable data on drug failures and thus tainted decades of clinical trials. He thinks that only full disclosure required by law will be sufficient to restore public trust in the industry.
He may be right, but even Dr Wolfe concedes that such legislation is highly unlikely to pass through Congress. Given that, the WHO's new plan for standardising and strengthening the disclosure of clinical trial data seems a good start to restoring the public's faith in clinical trials. As Ida Sim, project co-ordinator for the WHO's International Clinical Trials Registry Platform, and her colleagues argue in the Lancet, “sunlight is the best antidote to such free-floating distrust.”
http://www.economist.com/science/displa ... id=6941746