FDA authorizes unapproved diagnostic test, new uses for Tamiflu and Relenza

[Guest guest]

Has anyone seen a list of the politicians stockholders in Tamiflu

[besides Rumsfeld and Obama]?

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http://pubs.acs.org/cen/news/87/i18/8718notw2.html

MAY 4, 2009 VOLUME 87, NUMBER 18 P. 8 FIRST APPEARED ONLINE APRIL 28

HEALTH

Containing Swine Flu

FDA authorizes unapproved diagnostic test, new uses for drug

Britt kson and Jarvis



Dreamstime

People in Aguascalientes, Mexico, take precautions to avoid spreading

and contracting influenza.

U.S. OFFICIALS are scrambling to deal with an outbreak of swine flu

that is believed to have originated in Mexico and is rapidly

spreading across the globe. Tests have confirmed that hundreds of

people in at least 11 other countries, including the U.S., have been

infected with the newly discovered swine influenza A (H1N1) virus.

The Food & Drug Administration has responded to the threat by

authorizing the emergency use of certain antiviral drugs to treat the

virus and an unapproved laboratory test to help detect it.

FDA's action allows physicians to give the oral drug Tamiflu to

children less than a year old and authorizes the broader distribution

of Tamiflu and the inhalant Relenza. News of FDA's emergency

authorizations led to a jump in the shares of Roche, Gilead Sciences,

and GlaxoKline, which make the approved antiviral drugs.

The action also authorized the Centers for Disease Control &

Prevention (CDC) to distribute its real-time reverse transcriptase

polymerase chain reaction Swine Flu Panel diagnostic test to

qualified public health labs, even though the test has not been

approved by FDA.

General Info on H1N1 Flu

H1N1 Flu & You

Antiviral Drugs

Taking Care of a Sick Person

Facemask & Respirator Use

Images of the Virus

Audio & Video

The diagnostic works by amplifying viral genetic material from a

nasal swab. " A positive result indicates that the patient is

presumptively infected with swine flu virus but not the stage of

infection. However, a negative result does not, by itself, exclude

the possibility of swine flu virus infection, " FDA noted in a statement.

CDC is monitoring the scope and severity of the outbreak, and it has

released 25% of the antiviral drugs from its Strategic National

Stockpile to all 50 states.

Drug companies say they are well equipped to deal with a surge in

demand for their products. Amid fears of a global avian flu pandemic

in 2006, Roche significantly expanded its list of partners that

provide the key intermediates in oseltamivir, the active ingredient

in Tamiflu. A more robust supply chain enabled Roche to increase its

annual production of Tamiflu by more than 30% to 400 million treatments.

Emergency congressional hearings were held last week to discuss the

outbreak and to ensure that federal health agencies are properly

coordinating their efforts. And President Barack Obama asked Congress

for $1.5 billion to deal with the outbreak.

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