Based on a new study by Dr. Peter C. Butler, Division Chief of Endocrinology and the Director of the Larry Hillblom Islet Research Center at UCLA, the FDA and the European Medicines Agency have started to look more closely at Merck s diabetes drug, Januvia, a step which may lead to warnings on the drugs, or its removal from the market. Dr. Butler s original study suggested that this drug could lead to changes in the rat pancreas that would cause pancreatic cancer. But, according to Dr. Daniel J. Drucker, a professor of medicine at the University of Toronto and a consultant to many drug companies, Basically no one in the entire world over the last 10 years, with thousands of animals, has found what Dr. Butler found.
Dr. Butler s current study analyzed 37 human pancreases from organ donors who had died from causes other than pancreatic disease. Seven donors had taken Januvia and one had taken Byetta (sold by Bristol-Myers Squibb and AstraZeneca). What he found was that the pancreases of the individuals who had taken these drugs presented with more precancerous lesions than those who had not taken the drugs. He explained this finding, saying that the drugs increase levels of glucagonlike peptide-1, which may lead to earlier development of precancerous conditions in middle-aged individuals.
However, when looking closely at the study, one finds that the individuals taking these drugs were older than the other diabetics and had also been sick longer, two conditions that could explain the findings. Additionally, Dr. Fred Gorelick, professor of medicine and cell biology at Yale points out that the precancerous lesions found were early-stage ones. Many middle-age people have these and they often do not lead to cancer.
And Mark Schoenebaum, a pharmaceutical analyst at ISI Group adds, So far the safety concerns have not substantially reduced use of the drugs, though there are signs of possible softness recently. He goes on to say that evidence of a risk was weak and that the FDA would probably take no action.
ACSH s Dr. Gilbert Ross had this to say. With regards to Dr. Butler s original study, we have been saying since ACSH s founding in 1978 that mice (and rats) are not little men and cannot be used to accurately predict human conditions in drug research. And furthermore, the fact that Dr. Butler was the only one to find this over the last 10 years makes his study questionable. His current study also causes some concern. The population size only 34 subjects, 8 of which were taking this class of drug raises a red flag. And the alternative explanations seem much more plausible than Butler s hypothesis. Januvia and the one other drug in its class, Byetta, have been helping thousands of people with Type 2 diabetes. I hope that the FDA and the European Medicines Agency are prepared to conduct many more larger-scale studies before taking any action against these drugs.
