Swine Flu Emerges | Chemical & Engineering News
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Web Date: April 28, 2009

Swine Flu Emerges

FDA authorizes unapproved diagnostic test, new drug uses
Department: Government & Policy, Science & Technology

Federal officials are scrambling to deal with an outbreak of swine flu in humans that is rapidly spreading across the globe.

To date, tests have confirmed that dozens of people in the U.S. and Mexico have been infected with the newly discovered swine influenza A (H1N1) virus. A few cases have also been reported in Canada, Spain, Israel, and New Zealand, sparking fears of a pandemic.

The Food & Drug Administration responded to the emerging threat by authorizing the emergency use of certain antiviral drugs and an unapproved laboratory test to help treat and detect the virus.

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. This action has lead to a jump in the shares of the companies that make these drugs. Roche, maker of Tamiflu, saw a 4.3% rise in its stock price on Monday. Gilead Sciences, which takes a cut of Roche's Tamiflu sales, was up 3.8%. Meanwhile, GlaxoSmithKline, maker of Relenza, is seeing its stock retreat from the 7.6% bump in shares seen yesterday. Both drugs can suppress activity of the swine flu virus.

FDA's action will also allow the Centers for Disease Control & Prevention (CDC) to distribute the real-time reverse transcriptase polymerase chain reaction (rRT-PCR) Swine Flu Panel diagnostic test to qualified public health laboratories.

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

Because of epidemiological data demonstrating human-to-human transmission and the ability of the virus to cause community-level outbreaks, Margaret Chan, Director-General of the World Health Organization (WHO), raised the influenza pandemic alert level from phase 3 to phase 4 on Monday, indicating that the likelihood of a pandemic has increased. The highest alert level is phase 6.

"A pandemic of influenza means that we have a new influenza virus to which most people in the world either have little immunity or no immunity," Keiji Fukuda, temporary Assistant Director-General for Health Security and the Environment at WHO, noted during a briefing on Sunday.

Given the widespread occurrence of the virus, containment of the outbreak is not feasible, Chan said in a statement. "The current focus should be on mitigation measures."

But CDC, citing an abundance of caution, issued an advisory urging Americans to avoid non-essential travel to Mexico, where the outbreak is believed to have started.

CDC is monitoring the scope and severity of the outbreak, and has released 11 million courses of antiviral drugs from its Strategic National Stockpile to affected states.

Though governments say they have sufficient stockpiles of the flu drugs, 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. At the time, Albemarle, Ampac Fine Chemicals, API Corp., Clariant, DSM, FIS, Martek Biosciences, Novasep/Dynamit Nobel, PHT International, PPG Industries, Sanofi-Aventis, Shaanxi Jiahe Phytochem, and Siegfried had all signed on. A more robust supply chain enabled Roche to increase its annual production of Tamiflu by over 30% to 400 million treatments.

Meanwhile, FDA, the National Institutes of Health, and CDC are working together to develop a vaccine precursor that manufacturers could use to make a vaccine for swine flu virus. "We don't think that any of the existing vaccines are effective," CDC Acting Director Richard Besser said at a briefing on Monday.

Rep. Frank Pallone Jr., (D-NJ), chairman of the House Energy & Commerce Subcommittee on Health, plans to hold an emergency hearing Thursday to discuss the swine flu outbreak. Pallone called the hearing to ensure that federal health agencies are properly coordinating their efforts.

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