WHO Blames TV Ads
Nearly 43 million preschool children worldwide are obese or overweight and television ads are greatly to blame, according to the World Health Organization. “Television advertising is responsible for a large share of the marketing of unhealthy foods, and according to systematic reviews of evidence, advertisements influence children's food preferences, purchase requests, and consumption pattern,” the organization said. In a 2010 recommendation, the WHO called for less exposure of children to ads that promote unhealthful foods, and condemned marketing messages that promote foods high in saturated fats, trans fatty acids, free sugars, and salt. “Implementing these recommendations should be part of broad efforts to prevent unhealthy diets – a key risk factor for several noncommunicable diseases,” Dr. Ala Alwan, WHO's assistant director-general for noncommunicable diseases and mental health, said in a statement.
Obesity Drug Hits Snag
The Food and Drug Administration has requested more information about an active ingredient in the experimental antiobesity and antidiabetes drug Qnexa. The agency declined to approve the combination of phentermine and topiramate last October and asked for more evidence about possible heart risks associated with the product. At question is topiramate, an active ingredient in migraine and epilepsy drugs. The agency has now asked Vivus Inc., maker of the phentermine-topiramate combination, to provide more information on topiramate and birth defects. The agent is suspected of increasing the incidence of cleft lip, the company said in a statement, adding that none of the babies born to 15 women who were exposed to topiramate or the combination drug in Vivus's trials had any birth defect. “Vivus anticipates continued dialog with the FDA on the planned resubmission” of the phentermine-topiramate new drug application, according to the statement.
Company Lost Billions on Drug
GlaxoSmithKline has posted a fourth-quarter charge of $3.49 billion to cover the cost of patient lawsuits and response to the federal government's investigation into the company's off-label promotion of its diabetes drug rosiglitazone (Avandia). “We recognize that this is a significant charge, but we believe the approach we are taking to resolve longstanding legal matters is in the company's best interests,” Elpidio Villarreal, senior vice president of global litigation for the company, said in a statement. “We have closed out a number of major cases over the last year and we remain determined to do all we can to reduce our litigation risk.” The FDA put restrictions on rosiglitazone because of data that tie the drug to increased risk of heart attacks.
Companies Join in Diabetes Push
Eli Lilly and Boehringer Ingelheim have joined forces to push toward approval several diabetes drugs at mid- or late-stage development. “Working together, we will comprise one of the most robust diabetes pipelines in the pharmaceutical industry,” John C. Lechleiter, Ph.D., Lilly chairman and CEO, said in a statement. The alliance “offers the prospect of near-term revenue opportunities as we address the upcoming loss of patent exclusivity for several of our products,” he added. The compounds for the project so far include two oral diabetes agents from Boehringer Ingelheim, two basal insulin analogues from Lilly, and possibly Lilly's anti-TGF-beta monoclonal antibody, according to the announcement. The companies will eventually share equally the costs and profits from the drugs.
France to Reform After Scandal
France has removed the diabetes drug benfluorex (Mediator) from the market after a report showed that at least 500 people have died as a result of taking the drug over the past 3 decades. The removal comes almost a decade after the United States and several European countries took such action when studies linked the drug to an increased risk of heart disease. France's Health Minister Xavier Bertrand has now promised to revamp the country's medical regulatory system, which relies heavily on pharmaceutical companies for funding. Benfluorex is made by France's second-largest drug company, Servier Laboratories.
Diabetes, and Its Costs, Doubled
The number of U.S. adults treated for diabetes more than doubled in 11 years, according to the Agency for Healthcare Research and Quality. In 2007, 19 million adults said they had been treated for diabetes, compared with 9 million in 1996, the agency said. The increase occurred in all age groups: from 4.3 million to 8 million among seniors; from 3.6 million to 8.9 million among people aged 45–64 years; and from 1.2 million to 2.4 million among 18- to 44-year-olds. Total treatment costs for diabetes also more than doubled, from an inflation-adjusted $18.5 billion in 1996 to $41 billion in 2007. Prescription costs alone more than quadrupled, from $4 billion to $19 billion.