U.S. FDA Authorizes Emergency Use of Tamiflu and Relenza to Better Respond to Swine Flu Outbreak

29 April 2009

The U.S. FDA has issued the following press release announcing that it is authorizing  the use of antiviral drugs Relenza and Tamiflu "to respond to the swine flu virus under certain circumstances.  This was done through the issuance of Emergency Use Authorizations (EUA). The full text of the U.S. FDA media release follows:

FDA News

FOR IMMEDIATE RELEASE
April 27, 2009

Media Inquiries:
Peper Long, 301-796-4671
Consumer Inquiries:
888-INFO-FDA

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.

Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.

The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.

In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

The test amplifies the viral genetic material from a nasal or nasopharyngeal 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.

The EUA authority is part of Project BioShield, which became law in July 2004.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone. 

--Online: www.fda.gov/MedWatch/report.htm 

--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 

--Fax: (800) FDA-0178 

--Phone: (800) FDA-1088

For more information:

FDA’s Emergency Use Authorization of Medical Products Guidance, go to 

www.fda.gov/oc/guidance/emergencyuse.html.

The FDA website is here.

You will note that the FDA issued the EUAs "in response to requests from the U.S. Centers for Disease Control and Prevention."  This is clearly part of the aggressive posture that the entire US government, led by the CDC, is adopting in response to the outbreak of swine flu virus that has now jumped out of North America and reached the Middle East (in Israel) and Oceania in New Zealand.

The EUAs basically expanded the use of the antiviral drugs for this swine flu emergency.  

In the case of Tamiflu for example which is "approved for the treatment and prevention of influenza in patients 1 year and older," the EUA, during the swine flu emergency, allows Tamiflu "also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year."

Also, the EUAs, allow both Relenza and Tamiflu "to be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses."

Please see a related post on Tamiflu and Arianna Anastos of Queens, New York.

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Demands of Dignity by Prof. Ed Aurelio "DING" Reyes

February 4, 2009

Prof. Ed Aurelio "DING" Reyes launched his book "Demands of Dignity," at IAME.  Prof. Ding is shown below signing a copy of his book. 

Here, Prof. Ding poses for a picture with friends, among them no less than Dr. Emmanuel T. Santos, aka Noli Santos (as in Noli Santos International Tower, that's where the IAME is located).  

In his Introduction, Prof. DING explains best the rationale for his present volume:

"Ten years ago, on the occasion of the Golden and Centennial anniversaries of UDHR [Universal Declaration of Human Rights] and TP [Treaty of Paris of 1898], respectively, an active network promoting a keen sense of history among the peoples of the Philippines spearheaded together with the largest alliance of human rights advocates in the country a human rights-oriented and historically-mandated project in the form of a '1998 Philippine Declaration of Felicitation and Protest.'

Through the efforts of Kamalaysayan and the Philippine Alliance of Human Rights Advocates (PAHRA) this was formulated and subsequently signed by over 300 history-oriented educators, human rights [advocates] and students from all over the country, and copies were delivered to the respective embassies of Spain and the United States, the office of the United Nations resident representative in the Philippines, and some other official addressees, including the embassy of France.

This 1998 Philippine Declaration expresses, among others, a demand for an official apology from Spain and the same from the US.  We got a response from the Spanish ambassador, and his makes for a very interesting reading.

Now, a full decade later, Kamalaysayan is launching as a campaign project a deeper and broader discourse on the contents of this 1998 Declaration, covering the effort to foster a deeper understanding and firmer grasp of both international documents along with their respective implications and consequences, and elaborating on the items for which we have earlier aired demands for apology.

To jumpstart this campaign and provide an intial folio of materials for circulation and discussion, this writer was tasked to put together this book, one of the thickest and most well-researched among his two dozen or so published works, full-titled, Demands of Dignity: Developing the Discourse on the Philippine December 10th Declaration, a Decade After.  This book comes out in standard hard-copy version of about 180 pages, and in electronic full and popular versions mainly for an international audience.

The first two chapters tackle why the UDHR and the TP are, respectively, "a cause for celebration" and "a cause for indignation." The third chapter elaborates in detail the bases of the demands for Spanish and American official apology to the Filipino people and to Humanity, and the last two chapters respond to the Spanish written response and to the American non-response to the 1998 Declaration.

We have been asked why we still bother with these two very old documents 'just because they got signed on the same date.'  Actually, these two are much more closely related than that -- they are mutually relevant.  And they form part of our continuing past, for better and for worse.  They are part of the History of Humankind, of all of us.  They are both covered by the Demands of Human Dignity."

Mr. Max de Mesa, Chairperson of PAHRA, wrote the foreword.  This is what he says:

"The author challenges our sense of time in relation to human rights.  How far can we appropriately and effectively reach out from the past to correct the present and to work together for common dignity in the future?

The people' struggles inform and reshape the human rights discourse not only its language but its content as well.  To be effective and relevant, human rights defenders from the concerned parties must thus engage in solidarity with those who struggle for their dignity and rights.  The people in turn must engage the duty-holders, as well as all claim-holders of human rights to ensure that they all enjoy the full implementation of these rights and obtain dignity for all concerned."

Dr. Noli Santos wrote:

"Demands of Dignity by Ed Aurelio C. Reyes is a fresh historical contribution to the mainstream radical intellectual tradition of Philippine struggle for recognition of human dignity, independence, freedom and democracy."

He ended his Prologue, thus:

"With the hindsight of history, we call on President Obama to issue a statement of apology to the Filipino people and the Republic of the Philippines to show to the world that America still stands by its basic values of respect for human dignity, life, liberty, freedom, truth, justice and pursuit of happiness.  We also request President Obama to order the immediate return of the historic Bells of Balangiga taken by the American forces and are still being kept in the US after more than 100 years.  This bell is part of the natural treasure of the Philippines."

To me, Demands of Dignity is unfolding, interactive history -- this is a theme that I will be returning to from time to time.  

It summons us as a nation to keep confronting our past, to move on beyond that past when we have learned its more relevant lessons to forge a future that beckons with peace, justice, progress and dignity.

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