Concerns about the safety of a new class of diabetes medicines increased a notch this week with a new report by medical investigators working for the British Medical Journal
and a U.K. documentary TV show that revealed unpublished data link the drugs to "unwanted proliferative or inflammatory pancreatic effects."
The report comes as health regulators in the U.S. and Europe are reviewing the safety of the lucrative drugs — known as incretin therapies and promoted as "the new darlings of diabetes treatment," the BMJ article notes. Past research has tied the meds to an increased risk of pancreatic cancer.
The BMJ report calls for the release of all safety information by companies that make such drugs, which include so-called glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors. The reporters argue that the Food and Drug Administration and the European Medicines Agency have not adequately responded to research suggesting the drugs, introduced in 2006, are less safe than manufacturers claim.
In the course of the investigation, the BMJ reviewed thousands of pages of regulatory documents obtained under the Freedom of Information Act. The data showed companies have not performed critical safety studies and regulators have not demanded them, according to the report.
"On their own the individual pieces of unpublished evidence may seem inconclusive," said Deborah Cohen, M.D., the BMJ's Investigation Editor. "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."
Dr. Cohen acknowledged that regulatory agencies are now reviewing the safety of the drugs. More information is expected this month, when the National Institutes of Health holds a meeting on possible links between diabetes, diabetes drugs, and pancreatic cancer.
Incretin therapies are taken by millions of people with Type 2 diabetes, with a global market of an estimated $9 billion a year. GLP-1 based drugs treat diabetes by regulating blood sugar. Some also suppress appetite and are being tested as a possible treatment for obesity.
Concerns about the drugs were first raised by by Peter Butler, M.D., from the University of California-Los Angeles, whose research showed pancreatic abnormalities in rats given the DPP-4 inhibitor sitagliptin (trade name: Januvia, made by Merck) several years ago. Dr. Butler later also found precancerous lesions in the pancreases of organ donors taking GLP-1–based drugs.
Three publications this year have raised concerns about the potential side effects of the drugs, prompting both the FDA and EMA to launch a review into whether the drugs may cause or contribute to the development of pancreatic cancer. But many scientists and manufacturers defend the drugs’ safety, saying the research evidence is weak.
The drugs in question reportedly include injectable GLP-1 agonists, exenatide (Byetta, Amylin/Lilly) and liraglutide (Victoza, Novo Nordisk); the oral DPP-4 inhibitors sitagliptin, saxagliptin (Ongylza, AstraZeneca/Bristol-Myers Squibb); linagliptin (Tradjenta, Boehringer Ingelheim/Lilly); and the recently approved alogliptin (Takeda).
Some consumer groups are calling for the drugs to be withdrawn until safety questions are settled.
"All drug licensing is about balancing benefits and risks," said Fiona Godlee, M.D., BMJ editor-in-chief, in a commentary accompanying the new report. "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."
In statements to the Channel 4 documentary "Dispatches" airing Monday, the drug companies said they are committed to patient safety and have vigorous safety processes in place.
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