The Patient Summit 2014

Jun 17, 2014 - Jun 18, 2014, London

An integrated approach to patient-centric outcomes

Potential Diabetes Risks from Unpublished Data Demonstrates the Need for Better Transparency Measures

Unpublished diabetes drug risks suggests that pharmaceutical companies need to be more transparent in their reporting of research data, warns the British Medical Journal.

Continuing the open data debate, an investigation by the BMJ and Channel 4, through their broadcast, ‘Diets, Drugs and Diabetes’, to be televised tonight at 10 pm GMT will demonstrate that various adverse effects of new diabetes therapies such as glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors that have not be revealed to patients globally.

As part of this investigation, the BMJ has analysed several regulatory documents, obtained under the freedom of information legislation and discovered that this unpublished data highlighted "unwanted proliferative or inflammatory pancreatic effects."

Additionally, even though published data has indicated safety concerns, in relation to these drugs, companies have not followed these findings with critical safety studies. Regulators have also not requested that companies perform these types of safety studies, once dangers become apparent.

Examples of the worrying effects of the GLP-1 based drugs were discovered by Professor Peter Butler at the University of California. He found that the pancreases of animals demonstrated worrying changes after receiving the GLP–1 drug, while there were abnormal effects with this therapy compared with other anti-diabetic drugs, which included pre-cancerous lesions, found in the bodily systems of eight organ donors.

Surprisingly, there has not been any investigation launched by regulators to conduct further research into the possible link between diabetes drugs and pancreatic cancer. This is set to change in the following weeks when the US National Institutes of Health will hold a meeting to discuss the potential links between diabetes, diabetes drugs and pancreatic cancer.

TheUS Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will also begin a review into whether these drugs can contribute to or cause the development of pancreatic cancer.Before this meeting takes place, various consumer groups have asked for the GLP-1 ‘obesity’ treatment to be taken off the market while we wait for this evidence.

The need for further investigation into the transparency of reporting research data is indicated by the BMJ’s Investigations Editor Dr. Deborah Cohen who says, “On their own the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug.”

BMJ’s Editor-in-Chief Dr. Fiona Godlee also highlights the importance of this investigation as she says, “All drug licensing is about balancing benefits and risks. But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.

The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds.”   

However, is it a simple task of publishing all research information? Even though the recent developments on the Clinical Trial Regulations aim to improve data transparency by making detailed summaries of research a necessity, not all parties are pleased. For instance, EFPIA believes that various amendments by the European Parliament’s Committee on Environment and Public Health (ENVI) will endanger patient privacy, the strength of regulatory systems and the benefits for investment in biomedical research in Europe.

Furthermore, pharmaceutical leaders such as Dr Jean-Michel Cosséry have previously questioned the need for initiatives that aim to demonstrate that data sharing is a good thing, as the industry is already aware that openness is important. But it is difficult to decide on a uniform format for publishing this data, so that this data can become available for all. So, perhaps, data transparency stakeholders should look into solutions for presenting this data to the public rather than simply pointing out the mistakes that our current system makes? 

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The Patient Summit 2014

Jun 17, 2014 - Jun 18, 2014, London

An integrated approach to patient-centric outcomes