The first week of July 2016 was a week to remember. A cluster of war related stories dominated the media, including the 100^th anniversary of the Battle of the Somme (1 July), the death of Elie Weisel on 2 July, on 3 July there was the deadliest bombing in Bagdad since 2003, three days later we had the release of the Chilcot report and the 45 minute response it drew from former Prime Minister Tony Blair, and on 8 July the deployment of NATO troops into Eastern Europe (for the first time since the end of the Cold War).

These events tend to underscore the importance of careful assessment of past mistakes and taking measures to prevent their reoccurrence. more…

Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years. And for years the drug regulator has failed to back up that talk with commitment and action.

The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug’s full safety and effectiveness profile is transparent, physicians and patients alike are at best misinformed. At worst, patients could suffer significant harm—even death—after taking a government approved, physician prescribed drug more…

Health Canada seems to want to have it both ways: be seen as a regulator that serves the public interest through a progressive commitment to transparency, yet be trusted by industry to not publicly disclose any clinical trial data which it calls “confidential business information.”  Given our experience over the past few months, we think Health Canada may be prioritising the latter at the expense of transparency.

Following the European Medicines Agency’s landmark 2010 policy (policy 0043), which has released millions of pages of clinical trial data without any strings attached, we optimistically believed that the passage of a new law in Canada was a sign Canada had given up on its historical preference for not sharing data. more…

The Ebola and Zika epidemics could be the catalyst to open up and speed up the publishing of science. During the Ebola outbreak, there were examples of researchers being unwilling to share results and data at the required speed, which might have compromised the public health response. After the emergency, leading funders called for incentives to share data and publish findings. The same funders recently called—importantly this time with publishers—for endorsement of a World Health Organization (WHO) statement on data sharing and discussed how it should happen.

The WHO statement emphasises the need for a shift in the approach to information sharing in emergencies, “from one limited by embargoes set for publication timelines, to open sharing using modern fit-for-purpose pre-publication platforms. Researchers, journals, and funders will need to engage fully for this paradigm shift to occur.” But why should this be the case only in emergencies? more…

You don’t have to look too far to see the benefits of systematic reviews and their summary results. The well known Cochrane logo depicts a real example, highlighting the value of systematically pooling data for meta-analysis and in this case demonstrating the clear benefit of corticosteroids in accelerating lung maturation in preterm babies.

Systematic reviews can also protect patients from harm. A systematic review of rosiglitazone, which was developed to treat type 2 diabetes, showed an increased risk of myocardial infarction. The review formed part of the evidence that ultimately led to the suspension of the marketing authorisation for rosiglitazone by the European Medicines Agency, despite the drug having been available for over 10 years.

So the production and use of systematic reviews to inform clinical decision makers is both appropriate and well supported. more…

The institution of the European Ombudsman celebrated its first 20 years of activity with a party for staff and all those who have and still are contributing to its work. The shindig was held in the European Parliament.

In the words of the current Ombudsman, Emily O’Reilly, the Ombudsman’s function “was born out of the debate on the emerging European citizenship in the early 1990s, and its purpose precisely is to enable those European citizens to hold the ever more powerful EU institutions to account, as the direct effect of what they do impacts more and more on the daily lives of the people. It acts in a complementary way to the courts and to the parliament, as a check on EU institutional power.”

In the current climate, O’Reilly’s words may seem like a wish rather than reality. Except that the office’s record in the matter of access to secret clinical data is exemplary. more…

Earlier this month Canadian news sources, including the CBC and the Toronto Star, reported on Dr Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and effectiveness of Diclectin (a widely used treatment for nausea during pregnancy). To its credit, the country’s drug regulator handed him thousands of pages of data from several clinical trials, including individual patient level data, in order for him to pursue his research. Yet it only did so after Dr Persaud signed a confidentiality agreement. The terms of that agreement provide an important test for Canada’s newly enacted transparency law, since they may limit researchers’ ability to meaningfully provide much needed scientific scrutiny of drug safety and effectiveness. more…

Fourteen years after a drug trial had been published, investigators —using multiple sources, including regulatory and legal documents—restored a version of the same trial and came to completely opposite conclusions.

The original study of 275 adolescents with depression—Study 329—concluded “paroxetine is generally well tolerated and effective for major depression in adolescents.” Yet the 2015 reanalysis in The BMJ, under the restoring invisible and abandoned trials (RIAT) initiative, is utterly at odds with this finding: “antidepressant trial finds popular drug ineffective and unsafe for adolescents.” more…

The European Medicines Agency (EMA) has issued its long anticipated new policy (policy 0070) on prospective access to clinical trial data, and is now in consultations to figure out the details of its implementation. We were invited to join these ongoing consultations, and have previously reported on the debate here and here.

We have been particularly concerned about the anonymization and redactions of the content of clinical study reports (CSRs), and especially concerned about the approach proposed by some in industry.

But now we are getting really worried. more…

In late 2010, the European Medicines Agency (EMA) became the first regulator in history to promulgate a freedom of information policy that covered the release of manufacturer submitted clinical trial data. Under a separate, new policy (policy 0070), the EMA will take an additional step and create a web based platform for sharing manufacturers’ clinical study reports (CSRs) upon a decision being made on a marketing authorization application or its withdrawal.

CSRs contain significant details that are often missing in journal publications of the same trials—for example, details pertaining to patient relevant outcomes and adverse events—and are an important new tool for those engaged in research synthesis. While the policy anticipates that the agency will require individual participant data (IPD) to also be shared, the EMA has not yet committed to a final timeline for this. more…