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Home My WebLink AboutCOM 0525.016 2008-2010 Murashige. Laura WMM. 625.2- RES.237-og ,OQAPT '2 Page 1 of3 pI Cauun.. From: Roxanne Hampton [rhampton@co.hawaiLhLus] Sent: Monday, October 19,20093:43 PM To: counciltestimony@co.hawaiLhLus COUNI.r....CLERK Subject: FW: TRO to Enjoin HHS Secretary from Distributing Vaccines under Emergency ~W~ii~lfort1AWPJl R-Cf~F '1\ lE=D L. \..~ ".... . IJ 2069 GCT 19 pm Lf 25 From: l~[mailto:mitchfine@hotmail.com] Sent: Sunday, September 27, 20092:53 PM To: rj sativa; rhampton@co.hawaii.hi.us Subject: TRO to Enjoin HHS Secretary from Distributing Vaccines under Emergency Use Authorization \~.l:.o;:., > Date: Sun, 27 Sep 2009 17:45:59 -0700 > Subject: Corrected for typos/TRO to Enjoin HHS Secretary from Distributing Vaccines under Emergency Use Authorization > From: mitchellfine@gmail.com > To: len15@mac.com; mitchfine@hotmail.com > > On Sun, Sep 27, 2009 at 5:35 PM, mitch fine <mitchellfine@gmail.com> wrote: > > Dr. > > > > Per Section 564 (b)(l) of the Public Health Service Act (PHSA) the > > distribution of the A/H1N1 vaccine requires an emergency use > > authorization (EUA) through the FDA in order to waive the current good > > manufacturing practice requirements and/or the addition of adjuvants. > > Under Section 564 (b)(l)(C) it appears the HHS Secretary is claiming > > that this waiver is required under Section 319 of the PHSA because > > there has been a determination by the HHS Secretary that H1N1 may > > affect national security and involves a specified biological agent or > > a specified disease or condition that may be attributable to such > > agent(s).*** (see below for excerpt of Act) This determination also > > appears to be founded (as required by law) on communications between > > the HHS Secretary the CDC, Homeland Security and the NIH etc. > > > > There are additional requirements i.e. publication in the federal > > register under Section 564 (h)(l), risk benefits analysis and absence of > > alternatives as set forth in the ACT's requirement for a EUA. The law > > is written so that after taking these factors into consideration these > > agencies decide on the reasonable course. This is the lowest standard > > possible and require that any TRO must be formulated with the EUA > > requirements foremost in mind as most objections have already been > > contemplated. From reading the law it is clearly the intent of > > Congress to allow the HHS Secretary free action, in a declared or > > potential homeland emergency, to balance the benefit and risks as she > > sees fit. We would have to show willful misconduct or a preponderance of > > evidence that what they are doing is unsafe, unreasonable and that S.;LS" I > > there are scientifically accepted alternatives. Even then the chances Comm. No. Y 1 · <0. [. > > for a TROIs success would be small because the ACT does not require an Ref. To: . ~ Ref. Date uL:T 2 1 ZOU3 10/19/2009 Page 2 of3 > > evidentiary showing by the Secretary. It requires only the Secretary's > > reasonable opinion of the "evidence". > > > > Here is the sample interrogatory and the only questions that would > > most likely be deemed relevant requiring answers: > > > > 1) Mr. Secretary is it reasonable to claim AH1N1 exists? > > 2) Could it be infectious? > > 3) Could a lot of people get sick? > > 4) Does Homeland Security think this could possibly be a threat to > > National Security? > > 5) Mr. Secretary in your educated opinion after looking at whatever > > science you want to look at and talking to the heads of the industrial > > medical complex ( I do not know if any of these conversations are > > required to be part of the public record) do you feel that mass > > injection of these minimally tested, unproven biological > > products/vaccines and its adjuvants would be better for public health > > then no vaccines? > > 6) Is there a safer alternative to these vaccines? > > > > Once these threshold questions are answered as required by the EUA, > > the snowball results we are seeing are pretty much guaranteed in the > > face of a presumed infectious disease that could effect national > > secu rity . > > > > One area I focused on was the clinical trials that Novartis is > > currently doing in San Jose, Costa Rica at the Instituto de Atencion > > Pediatrica (IPED) a private clinic. These trials are being condu'cted > > by the Director of the Clinic - Adriano Arguedas Mohs. > > ClinicalTrials.gov identifier # NCT00973700. Arguedas is also the > > Director of pediatric care at the Institute of Medical Services, > > University of San Jose, Costa Rica. Novartis is testing Focetria > > formulated with MF59 adjuvant. This is a test of 784 healthy adults > > and preliminary results show that there is a robust immune response > > from Focetria and there do not appear to be any serious complications. > > I could not find the actual study's ongoing results and all my > > information comes paraphrased, most likely from a Novartis press > > release. There also seems to be positive opinions from CHMP in Europe. > > > > The Secretary of HHS is no doubt using this trial to buttress his > > opinion on the safety and efficacy of the vaccine. If this trial or > > any current trial being performed by Novartis, Sanofi Pasteur, > > Medimmune et.al. regarding the safety and immunogenicity of A/H1N1- > > SOIV could somehow be questioned scientifically as spurious or > > fraudulent and it could be shown that the Secretary is relying on that > > trial, this could form the first step of a TRO to counter question > > "5)" above. > > > > Dr. let me know if any of this helpful. If so do you or anyone on the > > team have the means or the inclination to ferret out the bad science > > of these trials? This is absolutely key since these ongoing trials are > > now forming the scientific basis upon which the EUA and the entire > > edifice of mass vaccinations is being justified by the HHS Secretary. > > In short, if we can demonstrate that the "science" of these trials is > > not reasonable or there is gross misrepresentation or fraud in the > > reporting of results, we would then have a legal basis for moving 10/19/2009 Page 3 of3 > > forward in Federal and/or State Court with a TRO to enjoin HHS and > > Novartis et.al.from distributing the vaccine. > > > > In Service, > > > > Mitch > > > > ***Excerpt edited from the relevant law: > > > > An unapproved drug, biological product, or device may be authorized > > for emergency use following a declaration of emergency by the > > Secretary of Health and Human Services. Such a declaration is based > > on one of the following... > > . > > A determination by the Health and Human Services Secretary that a > > public health emergency exists that affects or has significant > > potential to affect, national security and involves a specified > > biological, chemical, radiological, or nuclear agent(s) or a specified > > disease or condition that may be attributable to such agent(s). > > > > The Health and Human Services Secretary, through the Food and Drug > > Administration, may then issue an emergency use authorization for a > > particular product if, among other things, the known and potential > > benefits of the product outweigh its known and potential risks, and > > there is no adequate, approved, and available alternative to the > > product. The Secretary must impose required conditions on the > > emergency use authorization and may impose additional conditions, > > consistent with the Food, Drug, and Cosmetic Act. For more > > information on the emergency use authority, please see > > http://www.fda.gov/oc/guidance/emergencyuse.html. > > Insert movie times and more without leaving Hotmail@. See how. 10/19/2009