And here is also some bad news about the CDC's response to this flu crisis, and to the flu in general.
MCM How am I to treat patients with H1N1 flu? How am I to protect them from the treatment? by Meryl Nass, M.D. <http://anthraxvaccine.blogspot.com>http://anthraxvaccine.blogspot.com (for links to supporting documents) CDC has told medical practitioners from the beginning to <http://www.cdc.gov/h1n1flu/antiviral.htm>use Tamiflu or Relenza (the generic names of these drugs are oseltamvir and zanamivir) for treatment, or for prophylaxis of exposed persons. An <http://www.cdc.gov/h1n1flu/eua/>Emergency Use Authorization has been issued for these drugs, which allowed them to be released from the Strategic National Stockpile for distribution to states and localities, to be used outside the labeled indications, and to somehow <http://www.cdc.gov/h1n1flu/eua/pdf/fda_letter_tamiflu.pdf>avoid GMP (Good Manufacturing Practices) standards if necessary. However, although CDC has repeatedly told doctors to use the antivirals above, what it has failed to tell us, even once, even on its frequently updated website, is how effective we can expect these drugs to be. Nor has CDC gone into much detail about safety, particularly when the drug is being used on very young children, off-label. Since safety and efficacy are the only two facts one needs to know about any drug (apart from the fidelity of the manufacturing and distribution processes) these are two very big omissions. Furthermore, I want to know what clinical syndromes patients are developing that occur in those who become critically ill, so that I can treat those aspects of the illness in the best possible manner. Are seriously ill patients developing a secondary, bacterial pneumonia, sepsis or Adult Respiratory Distress Syndrome (ARDS)? Do they benefit from mechanical ventilation, steroids or antibiotics? This could be life-saving information, yet it is not being disseminated and I could not find anything related to it on the CDC website. If that is not bad enough, you may be interested to learn that the government has invoked the Public Readiness and Emergency Preparedness Act (<http://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act>PREP Act), which makes it almost impossible to sue the manufacturer (as well as the government) for injuries you sustain from use of Tamiflu and Relenza. How is that, you may ask: there has been no media coverage of this. But you can confirm it on <http://www.cdc.gov/h1n1flu/eua/qa.htm>CDC's website. Here is <http://www.fda.gov/oc/guidance/emergencyuse.html>how it works. Guess what? Tamiflu and Relenza were given the benefit of the PREP Act back in October 2008, by Secretary Leavitt, before there was any swine flu pandemic. The Center for Infectious Disease Research & Policy at the University of Minnesota had <http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/dec1608antiviral-jw.html>this to say last December:<http://www.ahc.umn.edu/> <http://www1.umn.edu/twincities/index.php> ... A recent declaration by HHS Secretary Mike Leavitt provides that state and local governments will be immune to liability related to the use of oseltamivir and zanamivir only to the extent the drugs are obtained by voluntary means, not confiscation. The Public Readiness and Emergency Preparedness (PREP Act) gives the HHS secretary the authority to do that, the document states. For a good primer on PREPA, the Congressional Research Service has written a valuable <http://www.usembassy.at/en/download/pdf/medical_biodefense.pdf>report. If use you Tamiflu or Relenza and develop a serious adverse reaction, you will be on your own. The manufacturer, distributors and the government program planners involved in the decision to invoke the PREP Act, were all given near-total immunity for liability by the Act. --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to Mark Crispin Miller's "News From Underground" newsgroup. To unsubscribe, send a blank email to [email protected] OR go to http://groups.google.com/group/newsfromunderground and click on the "Unsubscribe or change membership" link in the yellow bar at the top of the page, then click the "Unsubscribe" button on the next page. For more News From Underground, visit http://markcrispinmiller.com -~----------~----~----~----~------~----~------~--~---
