Diabetes Doctors And Drug Safety Watchdog Group Express More Concern Than Ever Following June 2013 BMJ Medical Journal Article(Posted by Tom Lamb at DrugInjuryWatch.com)
In mid-March 2013 we wrote this article, "Emerging Drug Safety Issue: Possible Increased Risk Of Pancreatic Cancer With Byetta, Januvia, And Victoza -- Little Is Known About Long-Term Effects", which has received alot of attention since then, especially recently, due to the growing controversy about whether these relatively new type diabetes drugs might cause pancreatic cancer.
We will start with the most recent development, as reported June 11, 2013 on the Medscape web site, "ADA: Independent Review of Incretins and Pancreatitis, Cancer" (free registration required):
The American Diabetes Association (ADA) is calling for all pharmaceutical companies involved in the development or marketing of incretin-based diabetes drugs 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.
The day before, June 10, Medscape published this related article, "BMJ Digs Deep Into Incretins and Pancreatic Cancer Debate":
The issue of pancreatitis and pancreatic cancer associated with so-called incretin mimetic therapies for type 2 diabetes has been downplayed by the pharmaceutical industry, according to a new in-depth investigation by the BMJ....
The investigation begins by relating the story of how the concerns about pancreatitis and pancreatic cancer began to arise among the scientific community with regard to a new class of type 2 diabetes drugs, the glucagonlike peptide-1 (GLP-1) agonists and dipeptidyl peptidase (DPP-4) inhibitors....
Also, despite published reports that indicated concerns, pharmaceutical companies have not performed certain critical safety studies, nor have regulators requested them yet, the investigation has found. And access to raw data that might help resolve doubts about the safety of these drugs has been denied, it alleges....
The US Institute for Safe Medication Practices has also recently called for "further investigation" into the signal for pancreatic cancer with these drugs and said further studies of their long-term effects on human pancreatic and thyroid tissues are needed.
The concerns relate to a number of widely prescribed GLP-1–based therapies, the 2 injectable GLP-1 agonists, exenatide (Byetta, Amylin/Lilly) and liraglutide (Victoza, Novo Nordisk), and the oral DPP-4 inhibitors sitagliptin, saxagliptin (Ongylza, AstraZeneca/Bristol-Myers Squibb), and linagliptin (Tradjenta, Boehringer Ingelheim/Lilly).
Strictly Confidential, No Obligation.
This is the June 2013 BMJ medical journal article which was referenced above: "Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed?" (free full text).
And lastly, from "Has Pancreatic Damage From Glucagon-Suppressing Diabetes Drugs Been Underplayed? -- U.K. investigators cite growing safety concerns", published on the PTCommunity.com site:
More information is expected later this month, when the National Institutes of Health (NIH) holds a 2-day meeting on possible links among diabetes, diabetes drugs, and pancreatic cancer.
Dr. Fiona Godlee, Editor in Chief of BMJ, remarked: “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.”
We will continue to monitor this high-profile drug safety issue concerning cancer of the pancreas and the popular diabetes drugs Byetta, Januvia, and Victoza.
P.S. "Pancreatic Cancer and Incretins: No Signal as Yet at NIDDK" (6/14/13, Medscape)
EXCERPT: Following the NIDDK meeting yesterday, John Buse, MD, PhD, from the University of North Carolina School of Medicine, Chapel Hill, told Medscape: "The data from companies and other investigators suggest no signal of pancreatic cancer that can [currently] be detected. But it is going to take longer and larger studies to address this." Dr. Buse said it will be another 1.5 to 2 years before "substantial" data are available to further inform this issue....
Similarly, David Whitcomb, MD, PhD, chief of the division of gastroenterology, hepatology, and nutrition at University of Pittsburgh, Pennsylvania, an expert on the pancreas, who was a cochair of the 2-day NIDDK meeting, said: "This [idea of pancreatic cancer from these drugs] is something horrendous, almost too horrible to believe, coming out of the blue. But we just don't see those kinds of signals. There was a lot of concern and anxiety going into the meeting, but afterward, it was very reassuring....