Thursday, December 24, 2009

Building Markets, Avoiding Liability: a 2004 Example of Pandemic-Mongering/ Science

Here is a typical piece of industry hype on the dangers of a future pandemic, the need to build a bigger industrial base for vaccine production and the need to stockpile Tamiflu. But it didn't appear in an industry publication; instead it was published in Science, the US's premier scientific journal. The title is INFLUENZA: GIRDING FOR DISASTER. Facing Down Pandemic Flu, the World's Defense are Weak, by Jocelyn Kaiser.

The article pounds the drum regarding the need to protect manufacturers from liability, repeats the "millions of deaths" mantra, and no doubt helped push along billions in funding for Tamiflu and H5N1 vaccine development and stockpiling.

Can someone please tell me how you can assure adequate safety testing when manufacturer liability is waived? Unless manufacturers have tested enough to know about their products' problems, millions of people will be at risk from using medical products rushed into use. Yet US law says that manufacturers can only be liable for damages if they know about problems and choose to ignore them. Thus manufacturers are incentivized to perform the most minimal testing allowed. Is that why millions of doses of vaccine from 2 manufacturers were recalled for potency problems in the past 2 weeks?

In 2004 10 Tamiflu pills cost $10 wholesale. The retail price in my neighborhood this year was $100. Pandemic mongering is great for business. And as the BMJ pointed out 3 weeks ago, there is no reliable evidence it works. Excerpts from this piece follow; reading it will help you understand how the response to this year's swine flu epidemic was decided years ago, and had almost nothing to do with the characteristics of this year's virus.
... If Asia's potent H5N1 bird flu assumes a form transmitted between humans, this drug, oseltamivir, would be the world's only initial defense against a pandemic that could kill millions of people. But oseltamivir, sold as Tamiflu, is made by only one company, Roche, at a single plant in Switzerland. "We are living in a brave new world where we only have one drug," says flu expert Arnold Monto of the University of Michigan, Ann Arbor, who spoke before the working group meeting of the G7+ Global Health Security Action Group.

That grim assessment is one indicator of the world's vulnerability to pandemic influenza. Most virologists say a pandemic is a virtual certainty within the next few decades, if not from H5N1 then from another avian flu strain (see p. 392). When that happens, public health officials will have two tools to battle the disease: antiviral drugs and vaccines. But although research has produced effective new antivirals, they are expensive, and global supply falls far short of need. And a promising genetically engineered vaccine against H5N1 is still an experimental product only just now being tested in people.

After years of warning from flu experts, governments are finally beginning to respond. Some countries are starting to stockpile antivirals.

... However the vaccine is made, countries would need to pass legislation to shield companies from liability should the vaccine cause serious side effects, as did the swine flu vaccine. Some believe these problems will quickly be solved if a pandemic arrives. "What happens in a crisis is, a lot of the roadblocks get moved," says virologist Maria Zambon of the U.K.'s Health Protection Agency.

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