June 11, 2013 | By Márcio Barra
Data transparency in the pharmaceutical industry is a hot topic nowadays, and a new study by the British Medical Journal (BMJ) and the Channel 4 programme Dispatches brings more fire to the ongoing talks.
The study found unpublished data suggesting that incretin mimetics may double the risk of developing pancreatic cancer. Incretin mimetics mimic intestinal hormones such as glucagonlike peptide-1 (GLP-1) that stimulate the release of insulin after a meal, and include such drugs as GLP-1 agonists, like for example Byetta (exenatide), from Bristol-Myers Squibb and AstraZeneca, Novo Nordisk’s Victoza (liraglutide) and dipeptidylpeptidase-4 (DPP-4) inhibitors like Merck & Co’s Januvia (sitagliptin).
The BMJ reviewed a series of documents obtained under freedom of information requests, and found unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects”. Furthermore, 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”.
The study refers to three publications released this year which have raised concerns about the potential side effects of GLP-1 based drugs. On March 14 in response to the concerns raised by these studies, the Food and Drug Administration (FDA) announced that it would review the same research results on incretin mimetics. Shortly after, the EMA announced that they would too investigate the findings of a study in the journal Diabetes that suggested incretin mimetic drugs for type 2 diabetes increase the risk for pancreatitis and precancerous cellular changes called pancreatic duct metaplasia. Both the EMA and the FDA have confirmed to the BMJ that they have a “signal” for pancreatic cancer, but this does not mean there is a causal link.
This investigation was featured on Channel 4’s Dispatches programme, which aired yesterday at 8pm. In the programme, BMJ editors reported how manufacturers of the medicines “fiercely contested” the safety concerns and denied them access to raw data from the companies own research, which “would have helped resolve doubts about the safety of these drugs”. Writing in the BMJ, editor-in-chief Fiona Godlee said: “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.”
She added that 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”.
In response to the study, the American Diabetes Association issued a statement asking for all pharmaceutical companies with incretin mimetics in the market “to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer”.
For more on transparency on the pharmaceutical industry, read my short article on the subject.