There is an ongoing class action investigation being conducted into Onglyza (saxagliptin). This is a drug that has been used to treat diabetes since 2009. Onglyza regulates blood sugar levels in those with diabetes. It has been linked to pancreatic cancer, thyroid cancer, and other dangerous side effects like heart failure. The drug amassed $820 million in sales last year.
Onglyza is an incretin-based therapy drug. It is part of a class of DPP-4 inhibitors. These help the pancreas secrete more insulin and stop the liver from making excess sugar. A causal connection between heart failure and Onglyza has not been proven. However in April 2015, an advisory committee to the U.S. Food and Drug Administration asked the FDA to require AstraZeneca and Bristol-Myers Squibb, the manufacturers of Onglyza, to include a warning about possible heart failure on the label. 14 of the 15 members of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee felt the evidence merited the addition of the warning to the labels on these drugs. The other member felt that the drug should be taken off the market altogether.
Furthermore, multiple studies in 2013 revealed a strong link between Onglyza and pancreatic cancer. In 2011, multiple studies were performed involving other incretin mimetics. They showed a higher rate of malignant thyroid tumors in rodents and humans. Comparing them to subjects that took diabetes medications of a different class than Onglyza.
Many of the studies involving Onglyza show only small differences between placebo and non-placebo groups. One challenge for attorneys representing the plaintiffs will be proving that the results of these studies are statistically significant. Biostatistical experts will be extremely useful for the attorneys involved in this case. Biostaticians use math and statistics in their studies of biology to determine what findings are relevant and which are not. In a trial setting involving a drug manufacturer’s liability, a biostatician will be able to provide knowledge to the jury about whether an experiment, and the results it provides, provides a definite correlation between a drug and its side effects.
In finding whether a drug company had a duty to warn consumers of the dangers of their drugs, a biostatician will be able to look at the data the company relied on from its clinical studies before initially marketing the drug. If it can be shown that the company did know or should have known of the dangers of its product, then they will be more likely to be found guilty of a failure to warn.
