Tamiflu

> The Associated Press reports from Turkey that efforts to control the spread of avian flu in the country appear dangerously inept. Article

> On the other hand, there are encouraging signs as well. The WHO thinks one reason the fatality rate seems to be lower is that patients are being given Tamiflu.  …

A study in the New England Journal of Medicine warns that Tamiflu, the drug many governments and organizations are stockpiling to guard against a possible avian flu pandemic, may not work as well as some have predicted. The study, which was led by Oxford's Dr. Menno de Jong, looks at the case of two Vietnamese girls who died of the virus despite receiving the recommended dose of the antiviral. The finding also appears to throw into question suggestions that it might be possible …

Following reports of adverse events possibly related to Tamiflu, the Japanese Health Ministry said it will release information about the safety of prescription drugs. Starting in January, the Pharmaceuticals and Medical Devices Agency will publish detailed data on all of the reports it receives on adverse events caused by prescription drugs and medical devices on a Web site. The agency already publishes limited data on some events. Assuming the plan goes forward, the reporting initiative …

According to HHS Secretary Mike Leavitt, the US does not have the production capacity to make enough flu vaccine to guard against a pandemic. Leavitt, together with the CDC's Dr. Julie Gerberding, the NIH's Dr. Anthony Fauci and the WHO's Dr. Michael Ryan, appeared on NBC's Meet the Press to discuss the influenza threat. Leavitt cautioned that it will be at least three years before the US has the ability to protect its entire population.

- see this …

The FDA said it is investigating 12 deaths linked to the antiviral Tamiflu. According to authorities in Japan, the drug is linked to a number of adverse events and could be a factor in two suicides in Japan. An FDA spokesperson said the agency is not yet requiring any label changes, but may warn against a skin reaction caused by the drug. Maker Roche issued a statement saying no there is no evidence of any dangerous link.

- see this article from The New York Times

China's Ministry of Health says that it has its first reported human cases of the H5N1 virus, having detected the virus in three people. The news came in a brief announcement published by China's new agency. No additional details were provided. Some observers see the revelation as evidence of a new approach on the part of Chinese authorities. In the past, critics have taken issue with the limited access permitted by health officials.

- read this …

Shares in Roche and subsidiary Chugai pharmaceuticals fell on European markets Monday after reports that Japan's Ministry of Health is investigating two deaths linked to the antiviral Tamiflu. Officials said two teenagers are believed to have committed suicide after taking the drug. Known side effects include "impaired consciousness, hallucinations and other abnormal behavior." Tamiflu has been among the hottest sellers on the market in the past few months as governments and individuals …

The World Health Organization said it is drafting a plan that will try to prevent the spread of an avian flu epidemic by targeting an outbreak at its source rather than waiting for a pandemic to develop. Under the proposal being drafted by a small group of researchers at the international agency, WHO would use a stockpile of 3 million courses of the antiviral Tamiflu to hit any area impacted by the H5N1 virus as soon as signs of human-to-human transmission are evident. The plan reflects a …

Swiss pharmaceutical giant Roche Holding said it has suspended shipments of Tamiflu to pharmacy benefit management companies and other wholesale distributors after receiving reports of distribution problems. A Roche spokesman told The New York Times that some companies have been building stockpiles of the antiviral to guard against a possible H5N1 outbreak but did not provide more specifics. The company said shipments will resume when flu season begins in earnest. For those …

Supplies of seasonal influenza vaccine will probably be sufficient to meet demand for the 2005-2006 flu season, the Department of Health and Human Services said yesterday. National production is expected to be "adequate," although spot shortages may hit some areas. That's despite another disappointing year for Chiron, which last month announced it will not be able to meet its production goals. Total vaccine production is estimated to be in the range of 70 million to 88 million doses. …