Bird Flu Angst

World Health

With concern mounting over the availability of drugs and vaccines to battle a possible worldwide outbreak of avian flu, President George W. Bush met with pharmaceutical industry chiefs, and Health & Human Services Secretary Michael Leavitt toured Southeast Asia.

Leavitt, along with World Health Organization (WHO) officials, visited Laos, Cambodia, and Vietnam in an effort to assess the threat and coordinate a response to the possible spread of a strain of bird flu that has killed 60 of the 117 people known to have been infected in the region since 2003 and is now affecting birds in Romania and Turkey.

Health officials are concerned that the flu virus involved, H5N1, could mutate to a form that can be spread easily among people, potentially killing millions worldwide before adequate stocks of drugs and vaccines are available. In particular, the Bush Administration, still reeling from criticism of the federal response to Hurricane Katrina last month, has been criticized for not stockpiling sufficient doses of Tamiflu, a drug manufactured by Roche that is considered the best treatment for avian flu.

Leavitt's tour follows a week of efforts on the part of the Bush Administration and others to marshal drug and vaccine manufacturers in developing preventative and treatment regimens ahead of a possible pandemic.

President Bush met on Oct. 7 with CEOs of top vaccine makers. The U.S. State Department, meanwhile, convened meetings with diplomats from 80 countries and the United Nations to discuss ways of fighting a worldwide outbreak. The meetings coincided with a trip by UN General Secretary Kofi Annan to the Geneva headquarters of WHO, where he said that intellectual property concerns should not hamper the access to Tamiflu and other drugs that may be needed to fight a flu outbreak.

Asian health officials have gone further, calling for compulsory licensing of Tamiflu. Roche maintains it can meet demand faster than generics producers, given Tamiflu's 10-step, 12-month manufacturing process (C&EN, Aug. 29, page 20). The U.S drug industry's primary advocacy group, the Pharmaceutical Research & Manufacturers of America, also denounced calls for compulsory licensing, claiming it would introduce a disincentive to companies undertaking costly research into new therapies.

Persistent warnings about the dangers of a flu carried by birds transferring to humans were made less speculative with the recent publication of papers in Science (2005, 310, 28 and 77) and Nature (2005, 437, 927 and 937) that describe similarities between H5N1 and the 1918 Spanish flu virus that killed an estimated 20 million to 50 million people.

U.S. health authorities are willing to expedite the approval of a bird flu vaccine. John J. Treanor, associate professor of medicine at the University of Rochester and a principal investigator for NIH, tells C&EN that FDA is prepared to license a pandemic flu vaccine, as it does each year's new flu vaccine, based on data from a small number of subjects. He notes that clinical trials on a vaccine for H5N1 developed by Sanofi Pasteur were completed this summer, with results pending.

According to Treanor, 40 million two-course doses of a new vaccine could conceivably be ready six months after approval. The problem with moving forward, he says, is uncertainty about how the virus will mutate. If we knew that, eight months from now, we'd have a pandemic, it would be easy, Treanor says. Everybody would mobilize, and we'd be ready. What's so hard is that anything is possible.