Studies of the effects of incretin mimetics are crucial to understanding how these drugs may be affecting consumers in adverse ways.
Consumers rely on this information to make educated decisions when choosing medications.
Researchers who were not wholeheartedly convinced by the supposed safety of incretin mimetics decided to look to the FDA adverse reporting system to see how these drugs affected humans.
In individuals who took incretin mimetics, the researchers found an increase in the number of reports of pancreatitis and pancreatic cancer.
Yet, it was not just researchers who noted the link. In September 2008, drug manufacturer Eli Lilly noticed a connection between Byetta and pancreatitis.
However, they maintained that the warning on the drug of contracting acute pancreatitis was sufficient and adequately communicated.
Furthermore, in 2009, the FDA asked Merck and other companies that manufactured these drugs to do further safety studies using rats which resulted in the death of three rats.
Frighteningly enough, the pharmaceutical companies continue to state that these drugs cause no damaging effects.
In an independent analysis of health insurance published in February 2013, researchers found that people taking GLP-1 incretin mimetics were at twice the risk of hospital admission for acute pancreatitis as compared with people taking other anti-diabetic drugs.
In 2013, an independent body released the results of its research indicating that the entire class of incretin mimetics may carry up to 20 times the risk of developing pancreatic cancer for patients taking these drugs.
The Institute for Safe Medication Practices “ISMP” analyzed data from the FDA Adverse Event Reports between July 1, 2011, and June 30, 2012, from 1,723 patients taking these drugs.
The ISMP concluded that the increased risk of developing pancreatic cancer for patients taking these drugs could be as much as 20% higher than those who were taking other medications to control their type-2 diabetes.
Tom Moore, a senior scientist for drug safety and policy at the ISMP said, “I think the whole class is in question.”
Moore further stated that additional analysis is required, but “if the results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”
Although this data has some inherent limitations because it is based on adverse event reporting, it is a significant signal that more study and investigation should be undertaken, especially considering the other reports from different investigators found similar alarming connections between the drugs and pancreatic cancer.
The results of these studies are very unfavorable to the drug manufacturers who continue to maintain that their product is safe.
Unsurprisingly, this research has shown that these manufacturers continue to put profit above safety when they conduct inadequate testing and put unsafe drugs on the market.
In an effort to dismiss allegations that their product was unsafe, Merck offered to fund a professor at the University of California, Los Angeles to conduct a study about the effect of sitagliptin (Januvia) on rats that have diabetes similar to that in humans.
What should not have been a shock to Merck, the results of this study demonstrated that their product caused an increase in pancreatic damage.
During the 12-week study, the researchers gave the rats sitagliptin, metformin, or a combination of both drugs.
When examining the rats after the 12 weeks, the researchers found that every rat given sitagliptin had an enlarged pancreas.
Furthermore, one rat showed acute pancreatitis and 3 out of 16 had acinar to ductal metaplasia, a pathological change thought to be a potential precursor of pancreatic cancer.
Immediately after these results were published, Merck held a closed-door meeting to discuss the adverse findings.
In this meeting, a professor of digestive diseases said that the results of the study could suggest an increased risk of pancreatic cancer.
Had Merck and other pharmaceutical companies adequately tested these drugs before rushing them to the market, they likely would have found these results before the drug caused pancreatic damage to thousands of users.
