Washington, DCThe jury still appears to be out on Victoza side effects, with both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) taking a wait-and-see approach, eschewing any prospect of altering its position on the safety and efficacy of Victoza, but continuing to study liraglutide (Victoza) nevertheless.
However, amidst the fence-sitting are two streams of more decisive thought - the position of consumer advocacy group Public Citizen, which wants Victoza removed from the market altogether due to the potential association between Victoza and cancer. Then there is Victoza manufacturer Novo Nordisk, which has announced plans to increase its sales force in the US and push deeper into China.
At the center of the debate - a debate that has attorneys poised for the potential and onset of many a Victoza lawsuit - is research conducted by Dr. Peter Butler of UCLA. Butler and his colleagues identified a possible link between Incretin therapy (Victoza) and the potential for Glucagon-producing Neuroendocrine tumors, in research published online this past March, and in print this past July in the medical journal Diabetes.
Specifically - and an issue that appears to have carried weight with the EMA and the FDA - is the position taken by some that there are substantial methodological issues with the design of Butler’s study that limit the potential to draw conclusions. Butler answered his critics over the summer:
“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,” Butler wrote. “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 post marketing 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. Samuel S. Engel, et al. and Dr. Robert J. 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.”
It is interesting to note that Public Citizen began to lobby the FDA to remove Victoza from the market a year before Butler’s research suggesting Victoza Pancreatic Cancer was released. And Medical Marketing & Media (MMM 10/13) notes the decision by PBM Express Scripts, a pharmaceutical management group, to drop Victoza and stop making it available to its clients starting next year. Victoza manufacturer Novo Nordisk expects the latter to negatively impact sales.
However, even with the potential for more damning conclusions based on further research on the horizon, the Victoza manufacturer is launching a full-court press to promote and market the brand, according to MMM. Over a 12-month window ending in September 2013, Novo Nordisk added 10 percent to its headcount, or 3,350 new full-time employees - a mix of sales representatives, research and development and production jobs.
To that end, it’s full steam ahead for Victoza. Novo Nordisk is pressing into China and, according to MMM, is pursuing a new indication for Victoza with regard to obesity. The latter would expose Victoza to a new market, and an even larger number of patients.
Should Dr. Butler’s hypothesis with regard to adverse reactions, including Victoza Thyroid Cancer, prove more conclusive, one can expect the potential for lawsuits to increase exponentially as Novo Nordisk shows no sign of slowing down on its support of Victoza, in spite of some nagging doubts. Victoza already commands 70 percent of the global GLP-1 market. Novo Nordisk appears poised to grow that number even higher.
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