TRIAL AND ERROR

Europe has not learned a thing from the Tamiflu scandal

It’s been five years since European governments tried to fight the H1N1 pandemic and wasted a colossal $3 billion of taxpayer money in doing so. Back then, they stocked up on Tamilflu, a medication used on other types of influenza and marketed as a cure for the swine flu. It actually turned out to be “just as effective as aspirin” against the swine flu, save for “renal and psychiatric events” being among the side effects of the medicine.

What caused the scandal was not so much the wasted money. It was that Roche, the producer of the treatment, broke no law by hiding eight of the 10 clinical trial reports on Tamiflu. At the time, no law demanded the publication of the tests done to prove the effectiveness of the treatment, and because of that the efficacy of the medicine could be hyped up.

“60% of Tamiflu treatment clinical trials were unpublished,” says Tom Jefferson who, along with his colleague Peter Doshi, drew the world’s attention to the scandal, bringing to light massive government waste and the secrecy enjoyed by pharmaceuticals. And so, in 2012, the EU’s top pharmaceuticals watchdog, the European Medicines Agency (EMA), promised a public-access database for all future clinical trials to increase transparency.

Today, the EMA will be presenting its draft proposal for the database for approval. And, to the surprise of patient rights advocates, it seems like it has done a U-turn and learned nothing from the past.

While the database will indeed be open, the rules set to access it render it essentially “useless,” says Carl Heneghan, director of Evidence-Based Medicine and a founder of the AllTrials campaign. The users would be prevented from downloading the clinical trial documentation, which is essential to analyze studies that can be thousands of pages long.

“Science is about replication [of results] […] At the moment, no-one can check anything. Our regulatory system is unscientific,” said Heneghan who had initially welcomed the EMA’s pledge as step forward toward the end of clinical trial secrecy, and is now disappointed.

Some, like BEUC, a European consumer advocacy group, suggest the database regulation would contravene a new law passed by the European Parliament last month that makes it mandatory for clinical study reports to be publicly available, stipulating that “data should be presented in an easily searchable format.” The body which investigates maladministration in the EU institutions too said that the regulator’s “significant change” in policy “could undermine the fundamental right of public access to documents established by EU law.”

Some point out that EMA’s change in tune comes just one month after Abbvie, a US pharmaceuticals group, dropped its charge against the EMA, sued for releasing what the company considered commercially confidential clinical trial information. The EMA agreed to redact commercially sensitive parts of the documents. The consumer advocate requested the EMA to “clarify the impact—if any—of the settlement with Abbvie on the definition of the new policy.”

Even with an accessible database, the challenges to transparency wouldn’t be over: in the US, all trials are required to be published within a year of trial completion since 2007, yet a 2012 report revealed that a whopping 80% of trials were still unpublished in the country. So, as things stand, Europe still hasn’t devised effective measures to prevent another “Tamiflu scandal.” “It could happen again any time. If we don’t have the data and if the data is not independently assessed then you’re asking for trouble,” says Jefferson.

Follow Amana on Twitter @AmanaFK. We welcome your comments at ideas@qz.com.

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