Tuesday, November 24, 2009

Swine Flu update: did CDC's fuzzy math fuel vaccine-maker profits? And GlaxoSmithKline now warns of dangerous batch of vaccine in Canada

Above, watch CBS investigative reporter Sharyl Atkisson (a fellow UF Journalism School grad, by the way, though I doubt she'd remember me) discuss the H1N1 swine flu positive rates, data which the CDC has apparently been extremely slow to release. As it turns out, according to Atkisson's findings after her three-month-long investigation, only a small fraction of cases flagged by doctors as possible H1N1-swine flu actually tested positive for the virus, and some weren't even influenza cases at all; furthermore, the per-state rates of Americans testing positive for this so-called pandemic are surprisingly low--so low, in fact, one might, like Atkisson's guest, Alicia Mundy (reporter for the Wall Street Journal), be moved to question the media panic, not to mention the logic--and economic sense--of calling for so many school-closings and business shutdowns. Please watch and draw your own conclusion.

In related news: early this morning comes disturbing news that Big Pharma giant GlaxoSmithKline has notified Canadian healthcare professionals that a batch of their vaccine may trigger life-threatening allergies. GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, CSL Limited, and Novartis are the major multinationals producing the vaccine that is currently in wide promotion and use in the US, Canada, and Europe. The US Department of Health and Human Services decided to use only non-adjuvated H1N1 vaccine at this time (a decision they argue was a good one). The corporations' non-US formulations (like GSK's) contain a controversial adjuvant and are being administered in Canada and Europe.

Vaccine adjuvants are various substances, like aluminum or water-oil mixtures, that are added to a vaccine to boost its effectiveness; in turn, they allow smaller doses to be administered and thus can stretch supplies, should they become limited. No adjuvated flu vaccine has ever been approved for use in the US. Critics argue that adjuvants are responsible for various ill effects of vaccines, including allergic reaction and death. While there is an obvious need to address the problem of vaccine demand outpacing supply, ongoing adjuvant research and development does not always turn up positive developments toward this end. If health organizations and vaccine makers aim to overcome potent anti-vaccination sentiment within the culture and win consumer confidence and trust, especially in the United States, they have no choice but to address the risks of adjuvant-related adversities, like autoimmune disorders, when they occur in trial:
The use of immunostimulatory molecules as immunopotentiators/vaccine adjuvants raises theoretical safety concerns, owing to the possibility that some might induce overproduction of inflammatory molecules, leading to overt inflammatory reactions or induction of autoimmunity. Recently, human trials with Heplisav (developed by Dynavax), which combines hepatitis B antigen with a CpG sequence (ISS 1018), a TLR9 agonist, were halted in response to a serious adverse effect report from a Phase III trial. After receiving two doses of Heplisav, one of the vaccinees was preliminarily diagnosed with Wegener's granulomatosis, an autoimmune disease involving production of antibodies against neutrophils leading to inflammation of the vasculature.

Also at Cogitamus.

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