Drug Safety Regulatory Developments And The Ongoing Academic Discussions About Provocative 2013 Medical Journal Article By Peter Butler At UCLA
(Posted by Tom Lamb at DrugInjuryWatch.com)
We last wrote about the possible association between pancreatic cancer and the diabetes drugs Byetta, Januvia, and Victoza back in mid-June 2013. Now that we have just moved into autumn, we thought it a good time for a summary of what happened as regards this drug safety issue over the summer.
As background, this is the article we posted on June 12, 2013: "Cancer of The Pancreas: Possible Side Effect For Diabetics Who Use Byetta, Januvia, Or Victoza? -- Diabetes Doctors And Drug Safety Watchdog Group Express More Concern Than Ever Following June 2013 BMJ Medical Journal Article".
Going forward, in August we learned that both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) believe that the currently available data does not confirm recent concerns over an increased risk for pancreatic cancer with glucagonlike peptide-1 (GLP-1)-based diabetes therapies Byetta (exenatide), Januvia (sitagliptin), and Victoza (liraglutide).
From an August 1, 2013 Medscape news report, "FDA Sides With EMA on Incretin Diabetes Drugs":
Lisa Kubaska, from the FDA's Center for Drug Evaluation and Research (CDER), told Medscape Medical Newstoday, the FDA "had conversations with EMA and was aware of their analyses regarding the potential pancreatic effects of GLP-1 based therapies. Our general view is that their conclusions are consistent with our current understanding of the data."...
"FDA's review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs. Additionally, there is an ongoing epidemiological study," Kubaska said.
For now, "FDA believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time," she told Medscape Medical News.
And then there was the continuing debate about that controversial 2013 article by UCLA medical researcher Peter Butler, "Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors" (published online in March 2013, then in the print edition of the Diabetes medical journal in July 2013).
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As for that debate about Butler's research that suggests how Victoza, Januvia, and Byetta might cause cancer of the pancreas, or pancreatic cancer, here are some excerpts:
-- Comment on: Butler et al. Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.
Diabetes 2013;62:2595–2604: Samuel S. Engel, Gregory T. Golm and Brett Lauring
In summary, there are substantial methodological issues with the design of this study that limit the interpretation of the authors’ observations and the ability to draw conclusions from this work.
-- Comment on: Butler et al. Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.
Diabetes 2013;62:2595–2604: Robert J. Heine, Haoda Fu, David M. Kendall and David E. Moller
Given such limitations as those discussed above, the data presented in the article by Butler et al. do not adequately support the conclusion that the observed histopathologic findings can be attributed to prior therapy with [Januvia (sitagliptin)] or [Byetta (exenatide)].... Data from long-term randomized, controlled clinical trials (such as the ongoing large cardiovascular outcomes trials) are necessary to adequately assess this balance.
-- Reponse to Comments on: Butler et al. Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.
Diabetes 2013;62:2595–2604: Alexandra E. Butler, Martha Campbell-Thompson, Tatyana Gurlo, David W. Dawson, Mark Atkinson and Peter C. Butler
To summarize, we acknowledge that securing the precious resource of human pancreas under the circumstances of brain death has limitations that differ from large clinical trials. With this line of thought, we would portend rather than one form of study negating the other that both lines of investigation are vitally important and should be evaluated in terms of the potential safety of incretin therapy. Indeed, each study type can shed unique insights into this vitally important question.... With this, we support the recent suggestion by the American Diabetes Association that ongoing postmarketing studies of the incretin class of therapies should also be opened for independent scrutiny. Likewise, it has also been suggested that the pancreas sections of the nonhuman primates exposed to incretin drugs should be made comparably openly available. The credibility of the arguments raised about our studies by the correspondents [Dr. Engel, et al. and Dr. Heine et al.] would surely be advanced by such actions. In the end, our only desire (albeit clearly controversial) is to stimulate open exchange regarding this class of drugs for the purpose of positioning, to be best means possible, issues of patient safety.
We will continue to monitor regulatory developments at the FDA and EMA as well as academic discussions in the medical journals about the possible association between pancreatic cancer and the diabetes drugs Byetta, Januvia, and Victoza.
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