• Kirk Hartley

Research Data, Transparency and the FDA – Larger Lessons from Contrasting the Approaches of GS

Honesty and trust are keys to relationships of many kinds. A pair of news stories this week highlight practical and important issues about transparency and access to testing data regarding scientific research for medical treatments.

On the negative side, the maker (Dendreon) of a prostate cancer vaccine (Provenge) is now under attack for perhaps having manipulated data analysis to show a false benefit. As the story goes, FDA approval was sought and obtained based on data analysis that drew a line at patient age of 71 versus 65, with that difference said to have mattered. This article provides more specifics, and seems fairly persuasive.

In contrast, the much-fined GSK announced this week that it’s going to do even more publishing of detailed research data in anonymized form, and is going to make clinical trial data available to researchers with "valid" reasons to look at the data. A Reuters article is here, and the press release is here.

GSK’s steps seem positive for many reasons, even if the steps could go even further (e.g letting an investor service hire an expert to analyze the data.) On the litigation side, time will tell how increased transparency ties to, for example, lawsuits alleging "fraud on the FDA." Hopefully the increased transparency will produce more collective scientific knowledge, better outcomes, and reduce litigation.

The GSK press release strikes me as as a useful if over simple explanation, so it’s pasted below in full text:

GSK announces further initiatives to advance openness and collaboration to help tackle global health challenges

Issued: Thursday 11 October 2012, London UK

Tuberculosis (TB) ‘compound library’ to be made available to help stimulate research into TB

Investment in GSK’s Tres Cantos Open Lab to be doubled with an additional £5m funding awarded

Detailed data from GSK clinical trials to be made available to researchers to further scientific understanding and knowledge

GSK today announced new measures to further advance its commitment towards greater openness, transparency and collaboration. Speaking at a meeting hosted by the Wellcome Trust in London today, GSK CEO Sir Andrew Witty will outline new steps to build on the encouraging signs of progress resulting from GSK’s ‘open innovation’ approach to R&D, designed to help develop new solutions for the world’s most serious health challenges.Over the past few years, GSK has been making fundamental changes to its business model to become more open to sharing its intellectual property and knowledge, and to forming partnerships to help stimulate more R&D into diseases that most affect the world’s poorest people. Building on that progress, today GSK will set out new measures to help develop new and faster-acting treatments for tuberculosis (TB), a huge global health need where R&D has been at an impasse, and to support independent research into diseases of the developing world.GSK will also outline new commitments to share detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patients.

Commenting ahead of the meeting, Andrew Witty said: “As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges. However, the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone. We need to take a different approach – one focused on partnership, collaboration and openness. By being more open with our clinical trial data, we also hope to help further scientific understanding. I am pleased with the progress we have made so far to evolve our business model but we recognise there is more we can do and the new initiatives outlined today will enable us to build on this work.”

Sir Mark Walport, Director of the Wellcome Trust, said: “In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today.”GSK’s TB ‘compound library’ to be made freely available

GSK scientists have screened the company’s entire pharmaceutical compound library of more than two million compounds for any that may inhibit tuberculosis (TB) bacteria and will publish in a scientific journal the results of this process – about 200 promising hits that could act as new starting points for the discovery of new medicines for TB.This is the first time a pharmaceutical company will have made public its own proprietary compounds which have demonstrated signs of activity against TB. It is hoped this will encourage others to pursue a fully open approach to research in to a disease that causes around 1.5 million deaths around the world every year.This builds on a similar work carried out by GSK in 2009 to place all of its malaria compounds in the public domain. Since the publication of this data in 2010, GSK’s anti-malarial dataset has been shared with research institutions around the world, resulting in a number of promising research projects now underway.

An additional £5m funding awarded to GSK’s ‘Open Lab’

In a further move to foster the sharing of scientific knowledge and learning across the scientific community, GSK will double its funding for its ‘Open Lab’ at Tres Cantos, Spain, awarding it an additional £5m.The ‘Open Lab’ was established in 2010 to allow independent researchers access to GSK facilities, resources and knowledge to help them advance their own research projects into diseases of the developing world.Two years since the ‘Open Lab’ was established, there are now 16 research projects in the portfolio. For example, iThemba, a company supported by the South African Government, has worked on a project at the ‘Open Lab’ to identify potential new compounds against tuberculosis (TB), specifically multidrug, extremely drug resistant TB and co-infection with HIV-AIDS. There are further projects underway at Tres Cantos looking at TB, malaria, Chagas disease, leishmaniasis and sleeping sickness.The majority of these projects are supported by the Tres Cantos Open Lab Foundation, an independent, not-for-profit organisation established with £5 million in funding from GSK. Overseen by a board of leading scientists, the Foundation provides funding and support to researchers to help them develop and advance new ideas that could lead to new medicines to treat diseases of the developing world. Researchers supported by the Foundation are encouraged to share their work to ensure their discoveries are also accessible to other researchers.

Detailed data from GSK clinical trials to be made available

GSK is fully committed to sharing information about its clinical trials. It posts summary information about each trial it begins and shares the summary results of all of its clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 4,500 clinical trial result summaries and receives an average of almost 10,000 visitors each month. The company has also committed to seek publication of the results of all of its clinical trials that evaluate its medicines – regardless of what the results say – to peer-reviewed scientific journals.

Expanding further on its commitments to openness and transparency, GSK also announced today that the company will create a system that will enable researchers to access the detailed anonymised patient-level data that sit behind the results of clinical trials of its approved medicines and discontinued investigational medicines. To ensure that this information will be used for valid scientific endeavour, researchers will submit requests which will be reviewed for scientific merit by an independent panel of experts and, where approved, access will be granted via a secure web site. This will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research, to learn more about how medicines work in different patient populations and to help optimise the use of medicines with the aim of improving patient care. (emphasis added)

This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers will be able to access data from clinical trials conducted by different sponsors. GSK hopes the experience gained through this initiative will be of value in developing and catalysing this wider approach.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.


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