Forest to Pay $313M Fine
Forest Pharmaceuticals Inc. will pay $313 million and will plead guilty to felony obstruction of justice for distributing three drugs, including levothyroxine (Levothroid) for hypothyroidism, without Food and Drug Administration approval, the Department of Justice stated. The department also said Forest made “illegal kickbacks,” such as gourmet meals and cash incentives, to entice physicians to prescribe the antidepressants citalopram (Celexa) and escitalopram (Lexapro). In its announcement, the Department of Justice detailed how Forest disobeyed FDA orders between 2001 and 2003 by ramping up production of Levothroid even after the agency told the company that it must stop. Forest discontinued its production of the unapproved version of Levothroid in 2003 and now distributes a different version of levothyroxine, also called Levothroid, under a supply agreement with Lloyd Pharmaceuticals, according to the announcement.
Society Warns of Disruptors
The Endocrine Society called on Congress to work with endocrinologists and other scientists to develop better regulations and screening programs for endocrine-disrupting chemicals. The substances “represent a significant health concern and their use has been so widespread that everyone has some level of exposure,” R. Thomas Zoeller, Ph.D., coauthor of the society's scientific statement on such chemicals, told policy makers at a Capitol Hill briefing. Dr. Zoeller and two other presenters explained how endocrine-disrupting chemicals have been linked to numerous health conditions, including pediatric obesity, asthma, autoimmune disease, and infertility. They called for comprehensive screening of chemicals for their endocrine-disrupting properties and for bans on those already known to have adverse effects.
Diabetes Drug Market Hits $25B
The worldwide market for diabetes drugs grew more than 16% to reach nearly $25 billion in 2009, making it one of the fastest growing areas of the pharmaceutical sector. The change is attributed to an aging and increasingly obese world population, according to a research report from Kalorama Information. The health-market researcher firm added that the high growth rate is likely to continue. “Diabetes is seen as kind of a 'safe bet' development area” for pharmaceutical companies, Bruce Carlson, Kalorama Information's publisher, said in a statement. More than 100 new diabetes products are in the pipeline, the report said. Top companies competing to secure market positions with those products include NovoNordisk, Sanofi-Aventis, GlaxoSmithKline, Merck, and Tekada, the report said.
Diabetes Drug Use Up
The proportion of people with diabetes who took oral medications for the condition grew from 60% in 1997 to 77% a decade later, while the proportion taking insulin to control diabetes fell from 38% to 24%, according to the Agency for Healthcare Research and Quality. In addition, use of sulfonylureas to stimulate the pancreas to produce more insulin decreased over the same 10-year period, while use of biguanides to reduce the liver's excess glucose production and thiazolidinediones to increase insulin sensitivity rose, the AHRQ said.
Insulin Noncompliance Tallied
More than one in every three diabetes patients said they failed to take their insulin as prescribed or skipped doses an average of three times in the previous month, according to a survey of physicians and patients by NovoNordisk. The survey also found that three-quarters of physicians think patients may be noncompliant with their insulin therapy as many as six times each month, not three times per month as the patients had claimed. Patients blame changes in their normal routines, being too busy, or simple forgetfulness for neglecting to take their insulin, according to the survey of nearly 3,000 physicians and patients in eight countries. Fear of hypoglycemia also may play a role: Two-thirds of patients said they were concerned about it, and three-fourths of physicians said they would treat patients more aggressively if they weren't afraid of hypoglycemic events.
Study: Mistake Policies Needed
When several patients are affected by a medical mistake – even one that probably will harm none of them – the event ought to be disclosed to the public, according to authors of a study funded by the Agency for Healthcare Research and Quality and published in the New England Journal of Medicine (2010;363:978–86). The authors said that “large-scale adverse events” from around the world have included everything from equipment malfunctions to poorly sterilized laboratory equipment. They advocated reporting policies that emphasize timely disclosure of such mistakes to government authorities, to the patients potentially affected, and to the media.