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Bird flu shows resistance to Tamiflu


SevenSeasJim
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It's coming boys and girls. Head for the hills.

Wednesday, December 21, 2005 Posted: 2243 GMT (0643 HKT)

LOS ANGELES, California (AP) -- In a development health experts are calling alarming, two bird flu patients in Vietnam died after developing resistance to Tamiflu, the key drug that governments are stockpiling in case of a large-scale outbreak.

The experts said the deaths were disturbing because the two girls had received early and aggressive treatment with Tamiflu and had gotten the recommended doses.

The new report suggests that the doses doctors now consider ideal may be too little. Previous reports of resistance involved people who had taken the drug in low doses; inadequate doses of medicine are known to promote resistance by allowing viruses or bacteria to mutate and make a resurgence.

Dr. Anne Moscona, a flu expert at Weill Cornell Medical College in New York City, called the deaths frightening and said they demonstrate the dangers of hoarding drugs.

"People who stockpile will naturally share or take drugs at the wrong dose, and that's really a bad idea," said Moscona, who wrote an accompanying commentary in Thursday's New England Journal of Medicine.

Since 2003, avian flu has killed about 70 people, mostly in Vietnam and Thailand, and nearly all involved close contact with infected birds. Health experts fear the virus could morph into a form that spreads easily between people.

Tamiflu and another drug, Relenza, are expected to be the front-line defense if that happens, but they must be taken soon after infection to be effective.

Tamiflu, made by Swiss-based Roche Holding AG, is the favored drug because it appears to be effective against all kinds of flu, including bird flu. GlaxoSmithKline's Relenza requires an inhaler and has not been widely tested in people with avian flu.

Concerns about Tamiflu resistance surfaced in October when doctors discovered it in a 14-year-old Vietnamese girl who had been given low doses as a precaution because she was caring for a brother with bird flu. She survived, and doctors theorized the low doses caused the resistance.

The new report involved eight Vietnamese bird flu patients given Tamiflu upon being hospitalized in 2004 or 2005. Half of the patients died. Lab tests showed two of those who died -- girls ages 13 and 18 -- had developed resistance.

In the case of the 13-year-old, doctors were especially surprised to see resistance because she was treated within the time frame when the drug was supposed to be most effective.

The study was led by Dr. Menno de Jong of Oxford University.

David Reddy, who heads Roche's influenza pandemic task force, said the study merits further investigation into whether patients need more of the drug.

Roche is conducting animal studies of different dosages to see which works best. Results are expected early next year.

In addition, Roche is working with the World Health Organization and the National Institutes of Health to begin a human experiment next year that would test whether doubling the current recommended Tamiflu dose is more effective, Reddy said.

Bird flu has some health experts worrying about hoarding of Tamiflu, which is tight supply as countries scramble to stock up.

In October, Roche announced it was suspending shipments to U.S. wholesalers and other private-sector recipients to ensure enough Tamiflu for the regular flu season. Roche is also negotiating with other companies to increase production.

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By the way, for all you conspiracy theorists out there: Rumsfeld owns shares in and is a former CEO of the company that makes Tamiflu.

Shoot Low -- They’re Riding Shetland Ponies!

from CNN (naturally)

Rumsfeld's growing stake in Tamiflu

Defense Secretary, ex-chairman of flu treatment rights holder, sees portfolio value growing.

October 31, 2005: 10:55 AM EST

By Nelson D. Schwartz, Fortune senior writer

NEW YORK (Fortune) - The prospect of a bird flu outbreak may be panicking people around the globe, but it's proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that owns the rights to Tamiflu, the influenza remedy that's now the most-sought after drug in the world.

Rumsfeld served as Gilead (Research)'s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.

The forms don't reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead's stock from $35 to $47. That's made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.

Rumsfeld isn't the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead's board, has sold more than $7 million worth of Gilead since the beginning of 2005.

Another board member is the wife of former California Gov. Pete Wilson.

"I don't know of any biotech company that's so politically well-connected," says analyst Andrew McDonald of Think Equity Partners in San Francisco.

What's more, the federal government is emerging as one of the world's biggest customers for Tamiflu. In July, the Pentagon ordered $58 million worth of the treatment for U.S. troops around the world, and Congress is considering a multi-billion dollar purchase. Roche expects 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004.

Rumsfeld recused himself from any decisions involving Gilead when he left Gilead and became Secretary of Defense in early 2001. And late last month, notes a senior Pentagon official, Rumsfeld went even further and had the Pentagon's general counsel issue additional instructions outlining what he could and could not be involved in if there were an avian flu pandemic and the Pentagon had to respond.

As the flu issue heated up early this year, according to the Pentagon official, Rumsfeld considered unloading his entire Gilead stake and sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics.

Those agencies didn't offer an opinion so Rumsfeld consulted a private securities lawyer, who advised him that it was safer to hold on to the stock and be quite public about his recusal rather than sell and run the risk of being accused of trading on insider information, something Rumsfeld doesn't believe he possesses. So he's keeping his shares for the time being.

on another related note, Gilead is currently taking a run at Roche to reclaim the rights to manufacture Tamiflu, claiming that Roche cannot handle demand.

follow the money!

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We're all doomed!

I've been raving on a street corner with a sandwich board warning people that the end of the world was near for years now and would anybody fuckin' listen? But that's okay, cause on my last visit to the mothership I managed to steal the antidote. After the planets population is decimated, I will emerge as ruler of the human race and you will all bow down to me.

All gifts and sacrifices should be sent to PO Box 956, C/O Merv Griffin Enterprises, to insure favouritism come armageddon.

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