U.S. Government Expands Bird Flu Tests in Alaska

20 January 2006 (Reuters)—Alaska, the resting spot for many migratory birds from Asia, will be the target of expanded tests to detect whether bird flu has reached North America, a government official said.

Alaska is considered to be North Amer- ica's most likely point of entry for the deadly H5N1 avian influenza, because it stands at a crossroads of wild waterfowl and shorebird migration to and from Asia.

At least 6000 wild migrating birds will be tested from across Alaska in the spring and the fall, said Rick Kearney, who is helping run the Department of Interior's flu-testing program.

“Alaska would be that place where the virus arrives in North America and is transferred from one type of waterfowl to another and migrates to the lower 48 (states),” said Kearney, wildlife program coordinator for the US Geological Survey. “Until it shows up someplace else, this is the point, the place where the most intensive effort is going to be.”

In 2005, government agencies tested more than 1000 live wild birds to see whether the H5N1 virus strain was present, and the University of Alaska Fairbanks tested an additional 3000 live birds over the past few years, Kearney said.

The tests did not uncover any cases of the H5N1 strain of bird flu.

Government officials expressed concern that birds migrating from Asia to Alaska this spring would bring the virus with them and eventually spread the virus to domestic poultry or some other receptor.

The Department of Interior, the Agriculture Department, and local organizations also plan to test an additional 7000 birds harvested by hunters in the spring and fall, Kearney said.

Editor's comment. It is important to recognize that this news item refers to avian influenza in wild birds only. The chances of spread to poultry in the United States are less than the chances of such spread happening in Eurasia, where a major part of poultry raising occurs in backyards and where there is ample opportunity for wild waterfowl to mingle with the backyard flocks. Also, it is important to remember that the human cases in Eurasia were primarily caused by contact with backyard flocks, with sparing of commercial poultry workers. Commercial poultry farms are less likely to allow mingling of poultry and wild waterfowl, and disease is rapidly recognized by death of poultry, allowing for prompt culling of the flock.

NIAID Stops Intermittent HAART Trial

18 January 2006 (Reuters Health)—The National Institute of Allergy and Infectious Diseases (NIAID) has halted enrollment in a large international trial comparing continuous HAART with intermittent therapy, guided by CD4+ cell counts.

The trial, known as Strategies for Management of Antiretroviral Therapy (SMART), quickly showed that patients do better while receiving continuous HAART, according to a statement released by the NIAID.

Patients in the intermittent arm had twice the risk of dying or progressing to AIDS. “Furthermore, there was an increase in major complications, such as cardiovascular, kidney, and liver diseases in the participants on the drug conservation arm,” the statement continued.

“These complications have been associated with [HAART], and it was hoped that they would be seen less frequently in those patients receiving less drug,” it added. The patients in the drug-sparing arm stopped treatment when CD4⁺ counts reached 350 cells/µL and resumed treatment when CD4+ counts dropped below 250 cells/µL.

When the trial was stopped, it had enrolled 5472 of a target of 6000 patients at 318 clinical sites in 33 countries. The trial was halted 11 January 2006, after an average follow-up of 15 months.

W.H.O. Issues New Malaria Treatment Guidelines

20 January 2006 (Reuters)—In new treatment guidelines, the World Health Organization (WHO) asked pharmaceutical companies to end the marketing and sale of single-drug artemisinin treatment for malaria to prevent the development of resistance.

“We request pharmaceutical companies to immediately stop marketing single- drug artemisinin tablets and, instead, market artemisinin combination therapies only,” WHO Director-General Dr. Lee Jong-Wook said in a statement. “It is critical that artemisinins be used correctly.”

When used correctly in combination with other antimalarial drugs, artemisinin is nearly 95% effective in curing malaria, and the parasite is highly unlikely to become drug-resistant, the United Nations health agency said.

Malaria kills at least 1 million people every year and makes 300 million people seriously ill. Ninety percent of deaths occur in sub-Saharan Africa, mostly among young children, according to WHO.

The director of WHO's malaria department said that no treatment failures due to artemisinin drug resistance have been documented yet, but the situation bears watching closely.

“We are concerned about decreased sensitivity to the drug in Southeast Asia, which is the region that has traditionally been the birthplace of antimalarial drug resistance,” Dr. Arata Kochi said.

In Thailand, sulfadoxine-pyrimethamine was almost 100% effective against malaria when introduced in 1977, but within 5 years the cure rate was only 10%, because of drug resistance. The once-popular chloroquine has lost its effectiveness in almost every part of the world, and resistance to atovaquone developed within 1 year of its introduction in 1997, the statement said.

WHO urged malaria researchers and the pharmaceutical industry to quickly invest in development of the next generation of antimalarial drugs.

Roche Says Now Shipping Tamiflu to All Markets

24 January 2006 (Reuters)—Swiss pharmaceutical company Roche Holding AG said it has lifted restrictions on the distribution of influenza treatment Tamiflu and is now shipping orders to all markets.

The company said it previously was distributing Tamiflu only to US cities where a high incidence of influenza was being reported.

Roche said it made the decision after seeing an increase in flu reports in the United States and an advisory by the Centers for Disease Control and Prevention urging doctors to avoid using 2 older flu drugs this season.

“We are prepared to meet seasonal demand for Tamiflu, including any increase stemming from CDC's recent announcement,” George Abercrombie, president and chief executive of Roche unit Hoff- mann-La Roche, said in a statement.

Glaxo Hopes for Pandemic Flu Vaccine by Year's End

25 January 2006 (Reuters)—Glaxo- SmithKline plans to start final clinical trials in a bid to find a vaccine against pandemic flu, which experts fear may be triggered by bird flu, its chief executive Jean-Pierre Garnier said. Garnier said the company hopes to produce the new vaccine by the end of this year.

“We are announcing that we are starting the final clinical trials in a few weeks so that by Christmas we might be in a position to produce large quantities of this pandemic vaccine,” Garnier is quoted as saying in a transcript of the interview.

However, Garnier said it was difficult to say how effective the new vaccine would be, given that it was as yet unclear how the H5N1 virus would develop.

“It's all a question of mutation,” Garnier said.

“If the mutation is a slight variation on H5N1 the vaccine is likely to be effective … But if it's a wide mutation, where the new virus is systematically different from H5N1 then … the vaccine is not going to be effective,” Garnier was quoted as saying.

On 6 January, GlaxoSmithKline said it had submitted a dossier to European health care regulators seeking outline approval to market a vaccine against pandemic flu, the first vaccine manufacturer to do so under new European rules designed to put potential pandemic flu shots on a fast track for approval.

GlaxoSmithKline is one of several companies working to develop a vaccine against the H5N1 strain of the virus.

Editor's comment. Any company that puts major resources into developing a vaccine against H5N1 avian influenza at this point is to be commended. H5N1 avian influenza may not be the next cause of an influenza pandemic, and even if it is, for the reasons pointed out above, the vaccing may be wrong.

Roche to Help Developing World's HIV Drug Makers

12 January 2006 (Reuters Health [Tom Ar- mitage])—Drug maker Roche Holding AG has launched a drive to help generic drug makers in developing countries produce cheap versions of a second-line HIV drug, the first move of its kind in the industry.

Roche will lend technical expertise to copycat drug makers in sub-Saharan Africa and to the world's least developed countries in a bid to increase local output of saquinavir, a drug used to combat the virus that leads to AIDS.

The drug is designed to be used as a second line of defense against the virus, after patients stop responding to the first choice drugs.

Roche believes that this is the first time that a pharmaceuticals manufacturer has lent technical support to companies that are producing generic versions of their drugs.

“From a layman's perspective, its manufacturing is slightly more difficult than first line therapy, but it is not super complicated,” he said.

More patients in the developing world are starting to take first-line antiretroviral drugs, after drug makers came under pressure to improve access to medicines.

However, the more first-line therapy that is taken, the more the virus develops resistance to the drug, meaning that the need for more-expensive second-line drugs, such as saquinavir, rises.