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By: Austin Kirk | Published: June 17th, 2013
The American Diabetes Association (ADA) is calling for an independent review of all available data involving potential side effects of incretin mimetic diabetes drugs, which include popular medications like Byetta, Victoza, Janvuia and Janumet, which have been linked to concerns over the past year involving a potential risk of pancreatic cancer.
Last week, scientists with the FDA and pharmaceutical companies that manufacturer the diabetes drugs met at the National Instutitues of Health to discuss the evidence linking Byetta, Victoza, Januvia and pancreatic cancer.
In a statement issued on June 10, the American Diabetes Association (ADA) asked all pharmaceutical companies who sell incretin mimetics to make patient-level data on their medications available for an independent review, so that researchers can provide clarity for patients and healthcare providers about the potential impact on the pancreas from the medications.
“People taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment and care in consultation with their healthcare providers,” said Robert Ratner, MD, Chief Scientific and Medical Officer with the American Diabetes Association.
The ADA has proposed releasing a call for applications from academic and research organizations that could integrate the data and settle the question of whether the diabetes drugs increase the risk of pancreatitis or pancreatic cancer.
In a statement responding to the ADA request, Merck, the makers of Januvia and Janumet, said they will work with the ADA to cooperate with an independent study.
According to a report by Bloomberg News last week, the FDA may be considering requiring the drug makers to establish a new large clinical trial study to evaluate patterns of adverse events associated with the medication.
Leading Medical Journal Joins Calls for Independent Review
The ADA’s recommendation for an independent review was echoed in an editorial published last week in the British Medical Journal (BMJ), which raises concerns about whether pancreatic damage from Januvia, Byetta and other incretin mimetic drugs may not have gotten enough attention.
In the editorial, Deborah Cohen, the BMJ investigations editor, asked why doctors and patients have not been adequately informed about the potential risks. Cohen wrote that officials in the U.S. and Europe have confirmed that their own analysis show increased risk of pancreatic cancer from drugs like Byetta, Januvia, Janumet and Victoza, but they have not found a causal connection.
“In the course of this investigation, the BMJ has reviewed thousands of pages of regulatory documents obtained under freedom of information and found unpublished data pointing to unwanted proliferative or inflammatory pancreatic effects,” she wrote. “The BMJ has also found that, despite published reports that indicated safety concerns, companies have not done critical safety studies; nor have regulators requested them. And access to raw data that would have helped resolve doubts about the safety of these drugs has been denied.”
Diabetes Drug Pancreatic Cancer Risks
Incretin mimetics are a relatively new class of diabetes drug, which work by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to a meal.
Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals and Eli Lilly in 2005 as a twice daily injection. Januvia was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and metformin was introduced in 2007, under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.
Side effects of Byetta, Januvia, Janumet and Victoza have been linked to a risk of pancreatitis, which could remain asymptomatic for a prolonged period of time, potentially resulting in the development of pancreatic cancer among some users.
The medications are widely used among individuals with type 2 diabetes, generating billions in annual sales. Januvia and Janumet are among the best selling medications for the global pharmaceutical company Merck, generating over $4 billion in sales last year. Victoza sales were about $1.8 billion last year for Novo Nordisk and Byetta earned a reported $149 million for Amylin Pharmaceuticals last year.
Concerns about the link between pancreatic cancer and use of Januvia, Janumet, Victoza and Byetta has increased since the FDA issued a statement in March that it was reviewing the findings of a recent study that identified pre-cancerous cellular changes among users of the medications. European health officials have also launched a similar review.
So far this year, a growing number of Januvia lawsuits, Janumet lawsuits, Byetta lawsuits and Victoza lawsuits have been filed in courts throughout the country by individuals diagnosed with pancreatic cancer after using the medications. The complaints allege that the drug makers have ignored signs that the medications increase the risk of pancreatitis, which could ultimately lead to pancreatic cancer.
A motion is currently pending with the U.S. Judicial Panel on Multidistrict Litigation to consolidate the federal litigation, asking that all complaints filed in U.S. District Courts throughout the country involving a diagnosis of pancreatic cancer from Janumet, Januvia, Victoza or Byetta be centralized before one judge for coordinated pretrial proceedings.
Oral arguments on the motion are expected to be heard at an upcoming hearing session scheduled for July 25, in Portland, Maine.