Philadelphia, PAHealth regulators in the US, Canada and Europe have shown they are far from ready to curtail sales or change the labels on any of the widely used type 2 diabetes medications that may or may not have a causal link to increased rates of pancreatitis and pancreatic cancer.
While the FDA and others may not see enough evidence to show a link between drugs like Merck’s Januvia and Bristol-Myers Squibb’s Byetta and Bydureon, attorney Maxwell Kennerly believes there is a considerable amount of information piling up. Although it may take some time to get all the answers, Kennerly’s clients, knowing their time is limited, are not prepared to wait.
“I don’t need to be blunt with clients, because the doctors have already been blunt with them,” he says. “When we talk about how long this process may take, they say, I understand. I just want to get the wheels in motion for the family I am leaving behind.”
There are, at the moment, about two dozen different drugs manufactured by seven different drug companies on the market for type 2 diabetes patients. The incretin-inhibitor drugs reduce blood sugar levels by mimicking the effect of hormones (GIP and GLP-1) that stimulate the production of insulin in the pancreas.
Over the last six years, a number of studies have raised alarms about incretin-inhibitor drugs. A study published in the journal Gastroenterology found some alarming numbers. Researchers at UCLA found that diabetes patients on Byetta (exenatide) or Januvia (sitagliptin) had a six-fold increased risk of pancreatic cancer and a three-fold increase in pancreatic cancer. In addition, UCLA scientists reported Byetta produced a four-fold increase in thyroid cancer.
“It’s not beyond the realm of possibility to think that changing the enzymes in your pancreas might end up resulting in cancer,” says Kennerly. “That’s one of the speculated mechanisms for how cancer occurs. The pathways are disrupted to a degree that causes cell mutations.
“You usually don’t find a definite link on the basis of one study,” says Kennerly. “What we see, however, are enough signals so that we are moving forward on these cases, and we think that in time there will be more research that will connect this group of drugs to pancreatic cancer.”
Kennerly, a seasoned litigation lawyer from the Beasley Firm, admits, as an attorney, he would “like more thorough and complete evidence.” However, he says, it is far from unusual to not have all the significant information in hand at this point in the litigation process. He compares the situation to the scientific investigation of the link between heart attack and Merck’s Vioxx drug.
“As the litigation kept going forward in the Vioxx case, more studies were done, and there was a recent meta study that found that the cox two inhibitors created the same cardiovascular risk as smoking and diabetes,” says Kennerly.
“You run into this question in all of these cases,” says Kennerly from his office in Philadelphia. “At what point do we start moving forward on the litigation? Because for statute reasons and for practical reasons, you can wait until you have had a 100 studies done on it.
“I would say every pharmaceutical case is a tough fight,” he adds. “And often, in these cases, as you go down the road and go through the discovery process, you find more and more data that completes the picture.”
Maxwell Kennerly is a graduate of Yale University and the Beasley School of Law at Temple University. He has represented a wide variety of personal injury clients and won the largest-ever medical malpractice award ($20.5 million) for a family whose daughter died during a liposuction procedure.
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