Is The EU's New Directive On Clinical Trials Moving In The Wrong Direction?

from the something-not-right-here dept

It's a cliché that we live in a world increasingly awash with digital data. Even though it all comes down to 1s and 0s, not all data is equally important or valuable. Data about clinical trials, for example, is literally a matter of life and death, since it is used to determine whether new drugs should be approved and how they should be used. That gives clinical data a critical role in the approval process: results that support the use of a new drug can lead to big profits, while negative results can mean years of expensive research and development have to be discarded.

Unfortunately, things aren't always clear cut, as an article in PLoS Medicine about Tamiflu makes clear: Prior to the global outbreak of H1N1 influenza in 2009, the United States alone had stockpiled nearly US$1.5 billion dollars worth of the antiviral. As the only drug in its class (neuraminidase inhibitors) available in oral form, Tamiflu was heralded as the key pharmacologic intervention for use during the early days of an influenza pandemic when a vaccine was yet to be produced. It would cut hospitalizations and save lives, said the US Department of Health and Human Services (HHS). If it could save lives and reduce complications, spending billions on stockpiling Tamiflu was a reasonable thing to do. But could it do either? Opinion seemed divided: In contrast, the Food and Drug Administration (FDA), which approved Tamiflu in 1999 and was aware of these same clinical trials [used to support this large-scale stockpiling], concluded that Tamiflu had not been shown to reduce complications, and required an explicit statement in the drug's label to that effect. FDA even cited Roche, Tamiflu's manufacturer, for violation of the law for claims made to the contrary. That is, even using the same figures from the same set of clinical trials, equally reputable organizations could come to different conclusions. Against that background, it's perhaps no surprise that the question of how much data must be released by drug companies during the approvals process, and in what form, is becoming an area of contention, because even small differences can tip the balance between a drug being approved and widely used -- and hugely profitable -- or barely used at all, and turning into a costly flop.

One battleground is Europe, where clinical trials data is covered by the Clinical trials Directive from 2001. It's currently being revised, not least because compliance costs have increased greatly in recent years: Compared to the situation prior to the application of the Directive 2001/20/EC, the staff needs for industry sponsors to handle the clinical trial authorisation process have doubled (107 %); with small companies facing an even sharper increase. For non-commercial sponsors, the increase in administrative requirements due to the Directive 2001/20/EC has led to a 98% increase in administrative costs. In addition, since implementation of the Directive 2001/20/EC, insurance fees have increased by 800 % for industry sponsors. That comes from the opening section of the proposed update to the regulations (pdf). Reducing costs in order to increase the number of drugs that are submitted for authorization is perfectly reasonable: everybody wants additional medicines to be approved that can both help people and support jobs in the pharmaceutical industry. But concerns are being raised that the new EU regulations would cut too many corners in doing so.

David Hammerstein, of the Transatlantic Consumer Dialogue (TACD) forum of US and EU consumer organizations, has the following concerns about the new Directive: 1. Lowers requirements and insurance for so-called "low risk" and "on market" drugs.



2. Easier industry manipulation of methodology to get results they want.



3. Ambiguous on Transparency: no clarity on what databases should be accessible.



4. Little transparency: Allows pharmaceutical industry to present only a summary of their data for EU database.



5. Destruction of valuable clinical data: Allows industry to destroy master files of clinical trial data after five years.



6. Tricky wording to avoid reporting negative results.



7. Whose benefit? Whose risk? His blog post has more detailed explanations, which is just as well, as the proposed Directive runs to over 100 pages of fairly impenetrable bureaucrat-speak. But assuming his fears are well founded, it certainly seems that the European Commission is going in precisely the wrong direction by providing "Less dependable data, fewer safety requirements and little transparency," as Hammerstein puts it. That would be bad news for any domain, but is especially worrisome when the health of 500 million Europeans is at stake.

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Filed Under: clinical trials, eu, healthcare