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Jack Sisson's Life Ethics Blog
We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.
Thursday, May 03, 2012
Debate on diabetes drugs gathers pace
A petition to ban the diabetes drug Victoza (liraglutide) has turned the spotlight onto studies that demonstrate its potential to cause pancreatic and thyroid cancer.
“We don’t just go after drugs casually,” says Sidney Wolfe, director of the health and research group at Public Citizen, a non-profit consumer-advocacy organization based in Washington DC, which sent the petition to the US Food and Drug Administration (FDA) on 19 April. “We only go after drugs when there is clear evidence of unique dangers or risks, and when there is no evidence of a unique clinical advantage.”
Public Citizen says that Victoza has a number of possible side effects; of those, critics are most concerned about pancreatic cancer. Once that cancer spreads, a patient stands just a 1.8% chance of surviving for longer than five years.
The petition rests in part on the work of Peter Butler, an endocrinologist at the University of California, Los Angeles. For some years, his work has been fuelling a debate on Victoza and other drugs in the same class — but until now, that debate has been confined to diabetes investigators.
Victoza, made by Novo Nordisk of Bagsværd, Denmark, was approved by the FDA in 2010. It is the second diabetes drug to mimic the activity of a hormone called glucagon-like peptide-1 (GLP-1), which stimulates the release of insulin from the pancreas and ultimately lowers concentrations of glucose in the blood.
In some people, drugs that mimic GLP-1 may inflame the pancreas, causing pancreatitis — a risk factor for pancreatic cancer. In 2009, the FDA ruled that such drugs must be labelled with a warning about pancreatitis; Victoza carries that warning, as do Byetta and Bydureon, formulations of the GLP-1 mimic exenatide, made by Amylin Pharmaceuticals of San Diego, California. Wolfe says his concern extends to other diabetes drugs that alter the GLP-1 pathway, but there was stronger evidence to make a case against Victoza.
Since 2009, Butler and his colleagues have discovered that such treatments might affect the pancreas by activating GLP-1 receptor proteins, which in turn stimulate proliferation of precancerous cells. His latest finding1 is that human and rodent pancreases contain lots of GLP-1 receptors in areas in which cancer is thought to originate, and mice that are genetically predisposed to pancreatic cancer develop the disease more quickly than usual in response to Byetta.
Butler hypothesizes that treatments based on GLP-1 might lead to pancreatic cancer in people with pancreatic abnormalities that might otherwise have remained dormant. Similarly, GLP-1 receptors inhabit thyroid tissue, which Butler says could account for cases of thyroid cancer that occurred during clinical trials of Victoza2.
“Butler has put together a hypothesis which is interesting and needs to be investigated,” says Edwin Gale, an endocrinologist at the University of Bristol, UK. “Pancreatitis may be just the tip of the iceberg, and it’s the iceberg that concerns me.”
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