Publishing information from clinical trials “risks damaging public health and patient welfare” says the US pharmaceutical industry. The industry body Pharmaceutical Research and Manufacturers of America (PhRMA) made the statement in a letter to Douglas Bell, the chief US trade negotiator for the free trade agreement between the European Union and the USA, the Transatlantic Trade and Investment Partnership (TTIP) deal. (TTIP is designed to increase trade between the EU and US by reducing barriers and harmonising laws covering everything from intellectual property to postal services. Most of the negotiations have been held behind closed doors.)
In the letter, PhRMA says, “Disclosure of companies’ non-public data submitted in clinical and pre-clinical dossiers and patient-level data risks damaging public health and patient welfare.”
We wrote to Mr Bell to tell him that the claims made by PhRMA are not true.
3rd July 2014
Dear Douglas Bell
You received a letter from the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group. According to media reports, PhRMA claims that transparency in clinical trials would put the health system, patients’ wellbeing and commercially confidential information at risk. We are writing to tell you that this is untrue. What is more, PhRMA’s opinion does not reflect the views of a growing number of major pharmaceutical companies.
GlaxoSmithKlein, Bristol-Meyers Squibb and Janssen, along with regulators, have found that it is perfectly possible to share clinical study reports (CSRs) and more detailed data with minimal redaction. We have challenged those clinical trial sponsors who have not joined them to explain how this puts patients and commercially confidential information at risk and they have not been able to cite a single example. People at PhRMA and others who repeat this claim do not show familiarity with the content of clinical study reports. Intellectual property remains protected by existing international agreements. CSRs and licensing applications do not usually contain detailed process information – this is contained in patents if they are filed. The data used to prepare applications is protected under regulatory data protection rules which are enforced in both Europe and North America, preventing a competitive application being prepared on the same data.
The world is moving towards a recognition that hiding information about what was done and what was found in clinical trials is an abuse of trial participants’ trust and exposes patients to unnecessary harm. More enlightened members of industry are working to rectify the problem. Progress towards greater clinical trial transparency will not stop and those who maintain secrecy will become more isolated. It is therefore ludicrous and misleading to attempt to seek trade harmonisation with that position in the TTIP negotiations.
We urge you to seek views from progressive and open members of the sector rather than from a trade association that has opted to work to the lowest standards. It is essential that this debate is conducted in public, to ensure there is a full and open discussion.
The AllTrials campaign steering committee:
Dr Ben Goldacre, Bad Science
Dr Fiona Godlee, editor-in-chief BMJ
Professor Carl Heneghan, Centre for Evidence-based Medicine
Dr David Tovey, Cochrane Collaboration
Sir Iain Chalmers, James Lind Initiative
Dr Virginia Barbour, PLOS
Tracey Brown, Sense About Science
The AllTrials Campaign for all clinical trials to be registered and results reported was launched in January 2013. It is supported by nearly 80,000 people and 500 organisations including regulators; medical schools and universities; medical bodies and Royal Colleges; consumer group BEUC; the European Patient’s Forum and more than 100 other patient groups from across Europe.
We will let you know when we receive a response from Mr Bell.