Diabetes drug risks fuel transparency debate
pharmafile | June 12, 2013 | News story | Research and Development, Sales and Marketing | BMJ, Channel 4, all trials, diabetes, transaprency
A new investigation by Channel 4’s Dispatches and the British Medical Journal is demanding that all trial data be released on new diabetes medicines as safety fears rise.
The investigation, which aired on the UK’s Channel 4 this week, looked at a new branch of treatment for type II diabetes known as GLP-1 drugs, which include Novo Nordisk’s Victoza and AstraZeneca/Bristol-Myers Squibb’s Byetta.
The BMJ and Dispatches programme found evidence suggesting potential harm from the drugs in industry studies that have not been published. These include data showing elevated risks of pancreatitis and cancer in some patients.
A number of medical experts and patient groups are now calling on the pharma companies to be more transparent in reporting of study data, and also to enter into dialogue about safety concerns.
In the course of this investigation, the BMJ says it has reviewed “thousands of pages of regulatory documents” obtained under freedom of information, and found unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects”.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, and nor have the regulators requested them.
All the companies involved strenuously deny that their drugs are unsafe and say they are ‘committed to transparency’.
Ongoing safety concerns
But this is not the first time questions have been asked about these medicines. In 2011 a European Association for the Study of Diabetes data review found a six-fold increase in the chances that patients receiving Byetta or Merck & Co’s DDP-4 inhibitor Januvia (which also raises levels of GLP-1) develop pancreatitis, which also significantly increases their risk of pancreatic cancer.
Victoza was approved in early 2010 but was subject to a series of delays by the FDA over concerns in an increase of thyroid cancers in pre-clinical studies.
The firm was ordered to carry out a five-year epidemiological study to evaluate thyroid and other cancer risks, as well as evaluate the risk for hypoglycaemia, pancreatitis and allergic reactions.
Because of its safety issues, the FDA recommend that those with or at higher risk of medullary thyroid cancer or pancreatitis do not take Victoza.
Data debate
The investigators said that access to raw data might help resolve doubts about the safety of these drugs, but argue that this ‘has been denied’, giving further fuel to the data transparency debate, headed up by the AllTrials campaign and the BMJ.
Dr Deborah Cohen, the BMJ’s investigation editor, said: “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.”
Some argue that the published evidence against the drugs is ‘weak’, say the BMJ, while others say the public can’t yet be sure that these drugs are safe, and are calling for all the study data to be made public for independent analysis.
Both the EMA and the FDA said they have a ‘signal’ for pancreatic cancer in these GLP-1 drugs after receiving a series of safety reports, but add that this does not mean there is a causal link.
Writing in the BMJ Dr Fiona Godlee, its editor-in-chief, 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: “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.”
Ben Adams
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