Something very right is trying to happen: Editor Fiona Godlee’s BMJ decision [God Save the Queen!…, in praise of Fiona Godlee…], the European Medical Authority’s plan [any news is good news…], the TEST Act in the US [the TEST Act…], AllTrials [click it and sign it…], the Cochrane Group’s negotiations with Roche about Tamiflu, etc. The push for data transparency in clinical trials is in the air from a lot of different directions. Now this from NICE:
In the latest move to pressure the pharmaceutical industry to release clinical trial data, the Health Committee at the UK’s National Institute for Health and Clinical Excellence has issued a report calling for drugmakers to place all information in “the public domain” and create a voluntary code for publicly releasing trial data for drugs once they have been reviewed and made available for clinical use. “The committee believes there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data about the efficacy and safety of pharmaceutical products,” the January 8 report states. “All information arising from drug trials should be in the public domain in an accessible and properly anonymised form, including any negative information.” “The committee does not believe it should be either legal or considered ethical to withhold research data about pharmaceutical products. It is, therefore, concerned that this simple principle is not universally applied in practice, and also concerned by the implication of Sir Andrew Dillon’s evidence that NICE are making appraisals of drugs without having access to all relevant data,” the committee concludes. Dillon is the NICE ceo…
The drug industry is still trying to play some cards to maintain control, like:
As for drugmakers, the Association of British Pharmaceutical industry released a statement prior to the release of the report saying “There is no doubt that we support enhanced transparency of clinical research and safety information. However, this must be balanced with the need to ensure that disclosure policies protect patients’ personal data, companies’ intellectual property rights and confidential commercial information in order to continue to develop innovative medicines in areas of unmet clinical need.” The committee report quotes ABPI director Stephen Whitehead as saying that “negative trials often give you as much information that is helpful as positive trials.” The trade group adds this: “Increasing amounts of clinical trial data are being published. In fact, following a change to the ABPI Code of Practice in 2012, companies are already obliged to publish all clinical trial results within one year of marketing authorisation and publically register new clinical trials within 21 days of the first patient being enrolled.”
There’s one word that won’t do – "voluntary." As the wisdom of the ages warns, "the best predictor of future behavior is past behavior." Can you say "mandatory?"
Mandatory, will do fine, thank you. Mandatory transparency would transfer control from private business to representatives of “we, the people” and that’s what politics and elections are supposed to deliver on key issues. Freedom from want. Safety. Pursuit of happiness. Justice. For all.
When I was young, every “important man” had stomach ulcers, my very important boss said. Then along came some young scientists deciding to research the firmly held belief that bacteria were not responsible. They found helicobacter poluri. An empire collapsed as medical devices industries and KOLs were ditched.
While awaiting scientific evidence of biological markers for steadily produced new labels for mental suffering, there are roads towards social justice and equality to be taken, that could lessen the burden of unnecessary suffering, and reduce the market for anti-depressant lykke-piller which are nothing of the sort. Profitable roads, for individuals and the public good.