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.

Tuesday, May 12, 2009

The Anthrax Vaccine: A Dilemma for Homeland Security/LtCol Tom Rempfer

This article, from the journal Homeland Security Affairs, recaps the history of the anthrax vaccine program and explores how the anthrax letters attack might be related to it.

Past problems with the Department of Defense anthrax vaccine currently impact
national emergency response plans approved by the Department of Homeland
Security and Department of Health and Human Services. Following the 2001 anthrax letter attacks, those departments diverged from long established protocols advocating limited use of the old anthrax vaccine, also known as BioThrax®. The Executive departments procured mass quantities of the product for the Strategic National Stockpile as a prophylaxis for citizens under emergency contingencies.
The departments share oversight responsibilities for the emergency stockpile’s
composition of vaccines and drugs based on Presidential Directives. (1) Yet a
review of past oversight efforts reveals regulatory problems, ethical controversies and dubious threat assessments underlying use of the vaccine. Based on the historic controversy, and studies suggesting the majority of U.S. service members continue to object to the vaccine’s use, (2) the government should resurvey the vaccine’s suitability for American citizens. A thorough review may find that widespread use of a known antiquated product of disputed safety and efficacy in treating a non- communicable threat provides an imprudent illusion of protection for our citizens.

This article explores the Department of Defense’s experience with the anthrax vaccine, and the troubling possibility that the 2001 anthrax letter attacks were a deliberate and successful effort to sustain a program that federal investigators determined was on the verge of failing. . .


Friday, May 8, 2009

U.S. funded anthrax vaccine trials on IDF soldiers/ Haaretz

According to an article by Yossi Melman, the US spent $200 million dollars for Israel to develop and produce an anthrax vaccine, and test it on Israeli soldiers during the 1990s.

When the US military was testing plenty of other experimental vaccines on American soldiers during the 1990s (I know of at least half a dozen) what might have led them to test this one offshore? What did the military know about the anthrax vaccine? And when did they know it?

It seems they knew it before the mass mandatory inoculation program began in 1998, but went ahead anyway. That program was initially slated to vaccinate every soldier, but after many vaccine refusals and production problems, vaccinations were limited to those soldiers deploying to Asia.

This story is getting a lot more interesting...

Thursday, May 7, 2009

CDC's anthrax vaccine safety studies defunded/ Science online

from Science: Michael McNeil's portfolio of flawed anthrax vaccine safety studies at CDC is going away. Drum roll, please.

This is a good thing, since the studies were basically a boondoggle lacking a scientific foundation. Even Army vaccine scientists, as well as this blog's owner, published criticisms of the laughable methodologies used by the CDC group in its first published study. That study purported to show no increase in cases of optic neuropathy following anthrax vaccine, by using idiosyncratic study methods that enhanced bias.

The Institute of Medicine was asked to review this study portfolio back in 2001. Here are some comments (verbatim) from their interim report in January 2002:
  • CDC's plan appears to include useful components that have not to date been integrated into a whole or comprehensive plan.
  • No matter how meritorious the parts, however, the apparent lack of overall planning and coordination of the whole is a deficit that should be remedied.
  • The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC's role in anthrax vaccine safety and efficacy research.
The final report of the IOM was ignored by CDC, which continued on with projects that IOM had found to lack merit and recommended ending.

This group also worked on the CDC anthrax vaccine trial, a 42 month study designed to look at long-term adverse vaccine reactions. What did they do instead? After the study had been completed, they published a paper discussing data from only the first 7 months of the study. This allowed CDC to hide long-term adverse reactions, and get the vaccine approved for civilians last October, potentially leading to large profits for the vaccine maker: Bioport aka Emergent Biosolutions. Qui Bono? Not the first responders who were slated for vaccination, since they were barred from seeking compensation if they got sick from either the manufacturer or government officials. Coincidentally, what barred them was an Emergency Declaration from HHS' Secretary Leavitt...conveniently issued the same month CDC published its paper and approved the vaccine for civilian first responders.

If CDC is serious about getting back on track with transparency, accurate information and quality research that will enhance public health, the anthrax vaccine safety group needed to go. Bravo to those at CDC who chose this program to cut.

FBI Anthrax Investigation Under Scientific Review/ Science online

Brief article by Yudhijit Bhattacharjee:

A long-awaited review of the scientific evidence relating to the investigation
of the 2001 anthrax letter attacks is finally getting off the ground. The study,
to be conducted by the National Academies, will check the validity of the
scientific techniques used by the Federal Bureau of Investigation in solving the
case. What the study will not do, as spelled out in the academies’ official
description of the study, is issue a verdict on whether U.S. Army researcher
Bruce Ivins was indeed guilty of the crime, as concluded by FBI officials. . .