Doctor Sounds Alarm on Januvia Pancreatic Cancer

According to the New York Times, Dr. Peter C. Butler a diabetic specialist at UCLA Medical Center, is sounding the alarm on Januvia related Pancreatic Cancer cases.

During his research, Dr. Butler found changes in the pancreases of study rats that could lead to pancreatic cancer. The research in 2008, lead to further follow-up studies, which now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes.

Dr. Butler, is the chairman of endocrinology at the University of California, Los Angeles. Based on his latest study, both the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.

Merck Denies Link Between Januvia and Pancreatic Cancer

Nancy Thornberry, who heads diabetes drug development at Merck, said that clinical trials, had found no increased risk of pancreatic disease from Januvia, even when results of trials were pooled to achieve greater numbers.

Byetta, the first of the class of Incretic Mimetics, sold by Bristol-Myers Squibb and AstraZeneca, was approved in 2005. Byetta is known to cause inflammation of the pancreas, a medical condition called pancreatitis and more serious is a possible risk of pancreatic cancer, which is virtually untreatable and kills most victims within a year.

Recently, lawyers defending drug companies against a lawsuit claiming that Byetta had caused a patient’s pancreatitis, subpoenaed Dr. Butler’s records. “I think the message here is they want him out of business,” said Brian Depew, a lawyer representing the plaintiff, Ross Hubert of New Hampshire, who claims that Byetta caused him to get pancreatitis.

More than 100 lawsuits representing 575 plaintiffs around the country are claiming injury from Byetta, mostly pancreatitis, according to the latest quarterly regulatory filing from Bristol-Myers. Forty-three suits claim that Januvia caused pancreatic cancer, according to Merck.

Other drugs in the class, called incretin mimetics, are Bydureon and Onglyza, which are also sold by Bristol-Myers Squibb and AstraZeneca; Victoza from Novo Nordisk; Tradjenta from Eli Lilly and Boehringer Ingelheim; and Nesina from Takeda. By far the biggest, though, is Merck’s Januvia and the related Janumet, which had global sales of $5.7 billion last year.

Dr. Butler said that the drugs work essentially by increasing levels of a hormone called glucagonlike peptide-1. That hormone might accelerate precancerous conditions already present in middle-aged people, much as the hormone estrogen might promote growth of nascent breast tumors. Dr. Butler and colleagues found far more cases of pancreatitis and pancreatic cancer reported for the incretin drugs than for Avandia, an older diabetic drug.

Public Citizen and the Institute for Safe Medication Practices, two watchdog groups, have also found the same thing. Public Citizen has already asked the F.D.A. to remove Victoza from the market.

Several research groups have looked at medical records of thousands of patients held by insurance companies. At least three of these studies have found no increased incidence of pancreatitis or pancreatic cancer. But a recent study found roughly a doubling of the risk of acute pancreatitis among users of the drugs.

But what has prompted the reviews by regulatory agencies has been Dr. Butler’s study of human pancreases obtained from 34 organ donors who had died for reasons unrelated to pancreatic disease. Seven of the donors happened to have taken Januvia and one had taken Byetta.

The pancreases of those eight people tended to have more precancerous lesions than the organs of the diabetics who had not taken those drugs, or those of the nondiabetics. There was also one case of a neuroendocrine tumor, a type of pancreatic cancer.

Also, the pancreases of the incretin drug users were heavier, with faster growth of certain cells. More information could come out in June when the National Institutes of Health will hold a two-day meeting on possible links between diabetes, diabetes drugs and pancreatic cancer. Dr. Butler will be one of the speakers.

“We have all these people out there taking these drugs,” Dr. Butler said, “and the problem is: What is happening to their pancreases?”