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Investigation into safety of new diabetes drugs -- will manufacturers release their data?
Date:6/9/2013

The BMJ and Channel 4 Dispatches investigated and found that evidence suggesting potential harm from the drugs in industry studies has not been published.

Some independent studies challenge the conclusions of the drugs manufacturers' own research. Now some medical experts and patient groups are calling on the pharmaceutical companies to be more transparent in reporting of study data and to enter into dialogue about safety concerns.

As a result, millions of patients around the world have not been fully informed about some of the possible risks.

Some critics say the drug regulators in Europe and the US have been slow to pursue concerns about the potential adverse effects of these new diabetes drugs, despite the emerging warning signs in the medical literature, regulatory documents, and adverse event databases.

Full details will be published on bmj.com on Monday 10 June and broadcast in Diets, Drugs and Diabetes Channel 4 Dispatches on Monday 10 June at 8pm on Channel 4.

GLP-1 based drugs are used to treat type 2 diabetes by regulating blood sugar. Some of these drugs also suppress appetite and are currently being tested as a possible treatment for obesity.

In the course of this investigation, the BMJ has reviewed thousands of pages of regulatory documents obtained under freedom of information and found unpublished data pointing to "unwanted proliferative or inflammatory pancreatic effects."

The BMJ has also found that, despite published reports that indicated safety concerns, companies have not done certain critical safety studies; nor have regulators requested them yet. And access to raw data that might help resolve doubts about the safety of these drugs has been denied.

Dr Deborah Cohen, the BMJ's Investigation Editor, says: "On their own the individual pieces of unpublished evidence may seem inconclusive, but
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Contact: Emma Dickinson
edickinson@bmj.com
44-207-383-6529
BMJ-British Medical Journal
Source:Eurekalert

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