Studies Do Not Negate Victoza Cancer Concerns

Washington, DCThe word came down late last year that a peer-reviewed study on Victoza side effects determined that the injectable, once-per-day type 2 diabetes drug posed no greater risk of pancreatitis and pancreatic cancer than other oral antidiabetic agents. At the same time, however, study authors noted that the follow-up time of 15 months used for the purposes of the study may have been too short to properly document incidents of pancreatic cancer.

It should also be noted that the study, “A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs,” published online in the professional journal Diabetes, Obesity and Metabolism (11/26/13), was co-funded by the manufacturer of Victoza, Novo Nordisk. The study also disclosed that some of the co-authors of the study were employees of Novo Nordisk, and held shares in the pharmaceutical company.

Kudos to the publisher and the study authors for properly disclosing potential conflicts. Nonetheless, does it suggest bias when it comes to the studying of Victoza and cancer?

It was in March of last year that the US Food and Drug Administration (FDA) issued a warning to the effect that Victoza and other drugs in the incretin mimetics class posed an increased risk for pancreatitis and pre-cancerous cellular changes, called pancreatic duct metaplasia. However, the FDA stopped short of mandating a label change, and instead adopted a wait-and-see approach while it further studied data. One can surmise that this latest study, suggesting that Victoza is no worse than any of the others, will keep the FDA on the fence.

But the risk for Victoza cancer remains palpable, nonetheless - and Novo Nordisk, to its credit, puts the warning at the very top of the official Victoza web page, “In animal studies, Victoza caused thyroid tumors - including thyroid cancer - in some rats and mice. It is not known whether Victoza causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early.”

Victoza is also not recommended for use in children under the age of 18 who may suffer from juvenile type 2 diabetes and may benefit from Victoza. Simply put, the effect on children has not been studied. That does not, however, preclude a physician from prescribing Victoza to a child if the healthcare professional feels the child could benefit from Victoza. Unlike manufacturers, who are prevented from promoting or marketing a product for any uses other than those which carry the blessing of the FDA, doctors have the legal and medical authority to circumvent FDA guidelines as they see fit.

So far, a Victoza lawsuit suggesting any serious adverse reaction - including Victoza Pancreatic Cancer - has yet to be filed. However, pundits suggest it’s just a matter of time. The issue could carry even more significant weight if a child’s health is negatively impacted by the use of the once-per-day injectable.

For its part, Public Citizen wants Victoza banned, period. The well-known advocacy group filed a petition with the FDA in the spring of 2012, citing the various risks - including Victoza Thyroid cancer - that in its view outweigh the benefits. Public Citizen noted that two FDA pharmacologists and an FDA clinical safety reviewer advised against approving Victoza.

The FDA, in its fashion, went ahead and approved Victoza anyway, in spite of the various links, risks and concerns over Victoza and cancer.