GlaxoSmithKline

Since a New England Journal of Medicine article came out strongly questioning the cardiac safety of its diabetes drug Avandia, GlaxoSmithKline has taken a beating, with its stock declining a substantial 11 percent over eight days. Now Glaxo has come back swinging, arguing that the furor is overblown. Glaxo's chief medical officer, Ronald Krall, has just published a letter in The Lancet arguing that Avandia is as safe as other diabetes drugs. In the letter, Krall notes …

Despite state laws requiring disclosure of pharma firm payments to doctors, pharmaceutical companies don't seem to be operating much differently in Vermont and Minnesota than they do elsewhere. The study, which appears today in the Journal of the American Medical Association, was co-authored by Peter Lurie, deputy director of consumer advocacy firm Public Citizen's Health Research Group and Health Research Group director Dr. Sidney Wolfe.

The researchers concluded that …

FDA Approves Alli(TM) (orlistat 60 Mg Capsules) Over-The-Counter

GlaxoSmithKline Consumer Healthcare announces today that the U.S. Food and Drug Administration (FDA) approved the weight-loss product orlistat 60 mg capsules for over-the-counter (OTC) use in the United States. GSK Consumer Healthcare will market OTC orlistat under the brand name alli(TM) (pronounced AL-eye). Approved for use by overweight adults in conjunction with a reduced-calorie, low-fat diet, alli helps people lose 50 percent more weight than with diet alone. alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over- the-counter product to be combined with a comprehensive support program. alli is expected to be available in stores nationwide by summer 2007. This approval marks the start of an educational program that includes a series of resources online at http://www.myalli.com.

According to some advocacy groups, it looks like pharma companies aren't coming up with free prescription drugs for the needy Medicare recipients, despite a pointed congressional request eight months ago. Several pharma companies had called off their drug assistance programs for Medicare patients once Part D became effective last year. The drug makers said that they were afraid they'd be accused of violating anti-kickback rules if they kept the programs open, though CMS has since said …

Last year was a good year for federal healthcare fraud investigators, who expect to recover a total of $1.47 billion from fraud cases filed in fiscal 2005, according to a report in political newspaper The Hill. Working under the auspices of the federal Health Care Fraud and Abuse Control Program, which began in 1997, the Office of the Inspector General, Department of Justice and Department of Health and Human Services have recovered a total of $8.85 billion to date, according to …

> The best of the month's health policy blogging is up at Health Wonk Review. Article

> Technical problems and bureaucratic delays have slowed the drive toward an electronic medical record for everyone in the UK, the Financial Times reports. But the problems have more to do with who will ultimately have ownership of the data. …

> Spiraling costs leave government with little choice but to intervene in healthcare. However, the lessons of Medicare Part D suggest that there is a right and a wrong way to do it, argues Highmark CEO Kenneth Melani. Article

> "Crimeware" programs that secretly log user keystrokes are set to become the most serious computer security issue, according to The New York Times. That, of course, is …

French pharmaceutical company Sanofi-Aventis said that early stage trials of its experimental avian flu vaccine have produced promising results, triggering a good immune response in trial participants. The latest version of the vaccine appears to work well at low dosages, a sign that plans to stretch the available supply developed by public health officials could work. Officials admit that the vaccine will need to be tweaked to offer protection against a new strain of the H5N1 virus if a …

The FDA is recommending warning label changes for three commonly prescribed asthma medicines, saying they can make the disease worse over time and lead to possibly fatal attacks. The agency wants new warnings on Severent, Advair and Foradil, three drugs used by asthma patients for the long-term maintenance of the condition. The news is a blow for British pharmaceutical giant GlaxoSmithKline, the maker of Advair. Sales of the drug were $4.7 billion in 2004.

- see this …

Vaccine maker Chiron said that it will not be able to meet its minimum production goal of 18 million doses in time for the 2005-06 flu season, again citing difficulties at its plant in the UK. CEO Howard Pien made the admission in a talk with analysts Monday but would not provide any additional details, leaving the extent of the shortage unknown. The news comes at a time when health officials are trying to calm public anxiety about the avian flu in the face of increasingly disturbing news …