European Regulator Finds Little Risk in Diabetes Drugs
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Version 0 of 1. Regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer, a finding that might reassure patients while also removing a potential sales threat for Merck and some other drug companies. “Presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines,” the European Medicines Agency said in a news release on Friday. Both the European agency and its American counterpart, the Food and Drug Administration, have been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca. A spokeswoman for the F.D.A. said the agency agreed with the European regulators that there was no cause for concern based on available data. But she said the F.D.A. review was continuing. The concerns have been raised over the last few years, mainly by Dr. Peter C. Butler, the chief of endocrinology at the University of California, Los Angeles. Dr. Butler has been hailed by some drug safety watchdogs as a hero for standing up to the drug companies, but he has also been criticized by diabetes experts as a zealot. In his latest study, the one that set off the reviews, Dr. Butler and colleagues examined the pancreases of 34 organ donors, some with diabetes and some without, who had died from causes other than diabetes. They found that the pancreases of the people who had used Januvia or Byetta tended to have more signs of inflammation and precancerous cellular changes than the organs from diabetics who had not taken those drugs or those from nondiabetics. But the European Medicines Agency said on Friday that Dr. Butler’s study had “a number of methodological limitations and potential sources of bias.” The donors who had taken Januvia or Byetta were older and had diabetes for far longer than the diabetics who had not taken the drugs, making it difficult to draw conclusions on possible effects. The agency said the prescribing information for the drugs already contained warnings about pancreatic inflammation, known as pancreatitis. It said clinical trials had shown no increased risk of pancreatic cancer, though the trials were too small to draw firm conclusions. It said that “some uncertainties remain” regarding the drugs’ long-term effects, but the much larger trials were under way to answer those questions. The drugs involved, which the F.D.A. calls incretin mimetics, increase the body’s levels of a hormone called glucagon-like peptide-1, which helps control blood sugar levels. Some of the drugs, known as GLP-1 agonists, mimic the effect of the hormone, while others slow the breakdown of the body’s own hormone. Collectively, the drugs had more than $9 billion in global sales last year. Januvia and a related drug, Janumet, also manufactured by Merck, together earned $5.7 billion. Mark Schoenebaum, pharmaceutical analyst at the ISI Group, said that the safety concerns surrounding Januvia had reduced Merck’s share price by $3. He said on Friday that the “overhang should now begin to dissipate.” Merck shares rose 32 cents, to $48.49. |