Investor campaign to press pharmaceutical companies for full clinical trial transparency

Joint engagement will run via the PRI Clearinghouse.

BNP Paribas Investment Partners, the Paris-based fund manager, is leading a new investor campaign to lobby the pharma sector in support of the AllTrials campaign being run by UK-based NGO, Sense About Science. It calls for much greater transparency around clinical trials, which are a necessary and crucial step in the process of drug development. However, the results from around half have never been published. Trials with negative results are twice as likely to remain unreported as those with positive results, while industry funded trials that have been published are much more likely than independently funded trials to show positive results. The AllTrials campaign, which grew out of the influential, best-selling book, Bad Pharma, by Dr Ben Goldacre, the physician, academic and broadcaster, has already attracted strong international support. It is now seeking to generate investor backing and is working with Rachel Crossley, former Director of Responsible Investment at Insight Investment, now an independent consultant, to develop the investor engagement strategy. Crossley said: “This is a campaign that deserves strong investor backing. The lack of transparency around clinical trials has serious and wide-ranging impacts on patients, health systems and trial participants.”
BNP Paribas Investment Partners will lead the new investor campaign, which aims to support AllTrials via a joint engagement through the Principles for Responsible Investment’s online Clearinghouse platform. The investor call will mirror that of the AllTrials campaign by asking pharma companies, and other companies that conduct clinical trials, to publish all results past and present. Helena Viñes Fiestas, Head of Sustainability Research at BNP Paribas Investment Partners said a study carried out by the fund manager had shown that withholding trials data can have significant implications for companies. She noted that some had already faced enormous fines as a result. As recently as 2013 several pharmaceutical companies paid a total of over US$10 billion in fines for not fully articulating secondary effects they were aware of. Companies are also criticised for wasting huge amounts of money conducting unnecessary trials that repeat unpublished trials which would be better directed towards research and development (R&D) and trials that have greater potential.Investors say that by not being transparent, pharmaceutical companies are putting their reputations at risk and undermining any public assurances they have made about operating ethically and responsibly.
They add that there is also potential for them to be misled because of the unpublished data. Clinical trials results, they point out, have a huge influence on stock prices by indicating whether or not a product works and defining its characteristics (i.e. its safety profile and how effective it is). An average of 30% of a company’s valuation is directly related to Phase III clinical trials’ results.
Governments around the world have strengthened regulatory requirements for registering and publishing future trials, but none presently mandate publication of data relating to past trials.
Analysis of the data on clinical trials, especially meta-analyses – the information on which regulators, doctors and patients base their decisions – has been show to be significantly biased. As a result, the decisions about which medicines to approve, prescribe and take have been made without the full picture of risks and benefits. Consequently, thousands of patients are estimated to have lost their lives or been seriously harmed. Many patients are likely to be taking the wrong drugs, drugs that are ineffective, or in some cases, no better than placebo. Health systems also bear significant costs. Doctors have been misled into prescribing expensive new drugs when existing cheaper ones are more effective and some governments have spent huge sums unnecessarily on ineffective drugs.

Investor briefing
An investor-only briefing is being held in London on 26 November, from 4 – 6pm. Speakers will include AllTrials campaign lead Sile Lane, Dr Ben Goldacre, Dr Trish Groves Editor in Chief of BMJ Open and Dr Robert Frost of GSK.
Contact to register or find out more.