Quoting initial reactions from certain doctors attending the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) conference, Medscape.com reports that medical experts see no increased risk between pancreatic cancer and Byetta-type pharmaceutical formulations. These reactions were received after listening to presentations reporting of results of studies associating these drugs to pancreatic complications including that of Dr. Peter Butler. Different studies were presented in this meeting in the hope of putting an end to this issue which has gone to the point that the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have been rapped by the British Medical Journal over the handling of this controversy.
There were many questions raised and there was much skepticism regarding the risk of cancer of the pancreas, according to Dr. Joseph Whitcomb, an expert of the pancreas and who acted as co-chairman of the NIDDK meeting. This view was shared by Dr. John Buse of the University of North Carolina School of Medicine when he stated that data from companies and other investigators suggest no signal of pancreatic cancer can be detected. Both doctors appear to give more credence to the presentations of medical experts connected with pharmaceutical companies than the study conducted by Dr. Peter Butler.
Three points were raised by Dr. Whitcomb in assailing the clinical trials performed by the team of Dr. Butler. Pointed out as the first concern was the ages of the subjects for both the control group who were in their 30s and the patients who were found to have pancreatic cancer who were in their 50s. According to the doctor, the critical issue was in defining the appropriate control group and when the right control group is used, there is no evidence of increased risk.
It was asserted by Dr. Whitcomb that the alpha-hyperplasia, the lesion found by Dr. Butler, is the wrong kind of cancer. What is associated with pancreatic cancer is glucagonoma, which was never found, and not hyperplasia.
The cells used in calculating hyperplasia which in this case used the weight of the pancreas was the third point raised. The pancreas of those with diabetes and in the elderly people tends to shrink, according to Dr. Whitcomb, which might have an effect on the results of the study.
In contrast, the claims of Dr. Alan Moses, the global chief medical officer of Novo Noridisk and Dr. Sam Enger, the medical expert from Merck, were given more weight by both doctors. Dr. Moses presented an analysis based on a five-year study which showed that the risk of pancreatic cancer was 0.7 compared to other diabetes drugs such as the common metformin. It was concluded by Merck that there was no increased risk of pancreatic cancer with the use of their medications based on a study using 14,00 patients from 25 randomized clinical trials.
Based on their reactions, even the Food and Drug Administration (FDA) would seem to agree with the position of both doctors which suggests that no signal of pancreatic cancer can be detected. This was based on its own evaluation using different studies and independent of those conducted by pharmaceutical companies. The FDA has assured that it will maintain its vigilant monitoring of the issue as well as to encourage long-term studies on the subject, perhaps as a way to assuage everyone concerned and to be in the safe side.
It is unfortunate that the side of Dr. Butler was not aired to answer these questions raised by the two doctors who incidentally have relationships with drug manufacturers. Reactions of the two doctors on the recommendations of the Institute of Safe Medication Practices (ISMP) and on the results of other studies such as the one conducted by Dr. Singh of the John Hopkins University would also be very welcomed by the millions of people affected with diabetes.