Wednesday, May 27, 2009

How am I to treat patients with H1N1 flu? How am I to protect them from the treatment?

The 2009 "Swine flu" A (H1N1) outbreak has been recognized for the past six weeks. It has been studied intensively, we are told, and a number of Americans have died from the disorder, although less than 1% of those diagnosed with this specific virus. It apparently is a bit more contagious than the usual flu, but may cause the same or fewer deaths than usual flu. However, since we have no good data on the number of Americans who die from flu every year, it is very hard to say how this swine flu compares to others in virulence.

CDC has told medical practitioners from the beginning to use Tamiflu or Relenza (the generic names of these drugs are oseltamvir and zanamivir) for treatment, or for prophylaxis of exposed persons. An 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 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 (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 CDC's website and in the Federal Register of October 10, 2008. Here is how it works.

Guess what? Tamiflu and Relenza were given the benefit of the PREP Act in 2008, by Secretary Leavitt, before there was any swine flu pandemic. The Center for Infectious Disease Research & Policy at the University of Minnesota had this to say last December:
... 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 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. The Declaration (and immunity shield) will remain in effect through the end of 2015.

1 comment:

John Morrison said...

It does seem suspicious that the PREP Act was invoked on these drugs last fall, and then this spring Swine Flu appears. However, I checked the Federal Register link, and they cited the Avian flu strains that scared the populace for a while.

Therefore, it remains at best a mild suspicion for me.

However, CDC's refusal to discuss treatment methods, safety, etc. seems like a smoking gun for something.