Dr. Peter C. Butler has been working on a study since 2008, which show worrisome changes in the pancreases of rats that could lead to pancreatic cancer. His discovery in follow-up studies just might threaten the future of the multi-billion dollar sales of Januvia, as well as all the drugs in its class. This would affect hundreds of thousands of patients with Type 2 diabetes.
Reports have indicated that several Type 2 diabetes therapy drugs increase the likelihood of pancreatic cancer 25 fold.
“I knew some stuff that I thought was a worry and I was obliged to pursue it,” said Dr. Butler, the chairman of endocrinology at the University of California, Los Angeles.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have begun investigations based on Dr. Butler’s latest study, which could lead to new warnings on the diabetes drugs, or perhaps their removal from the market altogether.
Dr. Butler and his colleagues have a long road ahead as they face powerful opponents in the drug manufacturers and several diabetes specialists, who believe there is no link between the diabetes drugs and pancreatic cancer.
Many people in the field are comparing Dr. Butler to Dr. Steven Nissen, the well-known Cleveland Clinic cardiologist whose warnings about Avandia, another diabetes drug, led to the banning of the drug in Europe and the high restriction of it in the U.S.
Dr. Butler is a former editor of Diabetes, the flagship journal of the American Diabetes Association. There are many who defend and believe in his findings.
The drugs, Byetta and Januvia, are in a class of drugs called incretin mimetics. There are several other drugs in this class, but none are as big as Merck’s Januvia (and the related Janumet) with global sales of approximately $5.7 billion last year. When incretin mimetics are taken, the drugs make the pancreas increase insulin levels, which help regulate the body’s blood sugar levels.
After the approval of Byetta, now sold by Bristol-Myers Squibb and AstraZeneca, in 2005, questions arose regarding the increased risk of pancreatitis associated with the drug’s use. Byetta’s labels contain warnings about this. However, new evidence raises the question of a more serious risk when taking Januvia. There is a potential possible risk of pancreatic cancer, which is untreatable and has a survival rate of no more than one year.
There are more than 100 lawsuits pending for 575 plaintiffs around the country who claim injury from Byetta. Most of the injuries are pancreatitis, according to the latest quarterly regulatory filing from Bristol-Myers. Currently, there are approximately 43 lawsuits that claim that Januvia caused pancreatic cancer, according to Merck.
Dr. Butler said that after his group presented its rat findings to Merck, “I never heard from them again,” except from their lawyers asking when the study would be published.
The studies performed by the drug companies that led to the drugs’ approval by the FDA, use young, healthy animals, which would never be expected to get pancreatic cancer, Dr. Butler pointed out. He said that the concern is that the drugs work by increasing the levels of a hormone called glucagon-like peptide-1. He believes that that hormone might accelerate precancerous conditions, which are already found in middle-aged people.
There is other evidence that raises concern, such as the side effects reported to the FDA, usually by doctors or companies, after the drug has already been on the market. Dr. Butler and his researchers found many more cases of pancreatitis and pancreatic cancer reported with the incretin drugs than for Avandia.
Two watchdog groups, Public Citizen and Institute for Safe Medication Practices (ISMP), have since found the same thing individually. Public Citizen has even requested that the FDA remove Victoza from the market. The ISMP released a report that indicated, “Injectable medications…were 28 times likelier to be linked to pancreatitis.” However, Merck & Co. and Bristol-Myers Squibb have both “denied an association between the drug and pancreatic cancer.”
These reports are not always reliable. It is believed that when a safety risk becomes publicized, there is sometimes an increase in reports of side effects.
Several groups have reviewed medical records of thousands of patients obtained from insurance companies, and although three of these studies have found no increased incidence of pancreatitis or pancreatic cancer, a recent study found almost a doubling of the risk of acute pancreatitis among users of the drugs.
The reason regulatory agencies have conducted more in depth reviews has been prompted by Dr. Butler’s study of human pancreases which were obtained from 34 organ donors, who have died for reasons unrelated to pancreatic disease. It happens to be that seven of the donors had taken Januvia, and one had taken Byetta. The pancreases of these eight donors contained more precancerous lesions than the organs of diabetics who had not taken the diabetic drugs, or those of non-diabetics. In addition, there was one case of pancreatic cancer. Dr. Alexandra Butler, pathologist also researching the link between Januvia and pancreatic cancer said that the pancreases of the incretin drug users were heavier, with faster growth of certain cells. “There were strange growths” that “you’d never see in a normal human pancreas,” she said.
The National Institute of Health (NIH) will hold a two-day meeting in June on the possible links between diabetes, diabetes drugs and pancreatic cancer. Dr. Butler will be one of the speakers present.
Also this summer, results will start coming in from large randomized clinical trials assessing whether the diabetes drugs raise the risk of heart attacks, as was linked to Avandia. It is hopeful that those trials will be able to detect an increased risk of pancreatic cancer that might have been missed by the smaller trials used to win approval of the drugs.
It is a possibility that the FDA will take no action.
Dr. Butler said that he was not looking for the drugs to be removed from the market, even though he does not prescribe them to his own patients. He believes that studies should be done using MRI scans to see whether or not the drug use is enlarging the pancreases of patients.
“We have all these people out there taking these drugs,” Dr. Butler said, “and the problem is: What is happening to their pancreases?”
Patients should be made aware of the possible risk, however small it may be, of pancreatic cancer linked to their diabetic drugs. They should make the decision of whether the risk outweighs the benefits. Fee free to comment on this blog post. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).