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HomeMy WebLinkAboutCOM 0525.015 2008-2010 Page 1 of 2 c~ 1 Z~ 2 pkoumcm Murashige, Laura Q S. 237-0q, DQAPF 2 From: Roxanne Hampton [rhampton@co.hawaii.hi.us] Sent: Monday, October 19, 2009 4:17 PM 20 OCT 19 P1 4 25 To: counciltestimony@co.hawaii.hi.us COO s= CLE-J-';1 Subject: FW: exemption COUNTv Attachments: swine flu BAR.doc From: Lorrin Pang [mailto:pang hi@hawaii.rr.com] Sent: Tuesday, October 13, 2009 10:14 PM To: 'Hampton, Roxanne' Subject: RE: exemption Aloha Roxanne, Please pass this to the Council members. The acronym BAR stands for Benefits, Alternatives and Risks (side effects). Lorrin -----Original Message----- From: Hampton, Roxanne [mailto:rhampton@co.hawaii.hi.us] Sent: Tuesday, October 13, 2009 3:29 PM To: Lorrin Pang Subject: exemption Dr Pang are you going to make it This is the one I am looking at [§302A-1157] Exemptions from immunization; not recognized; epidemic conditions. If at any time there is, in the opinion of the department of health, danger of an epidemic from any of the communicable diseases for which immunization is required under sections 302A-1154 to 302A-1163, no exemption from immunization against the disease shall be recognized. - Quarantine shall be a legal alternative to immunization. [L 1996, c 89, pt of §2] The Project BioShield Act of 2004 (S. 15) became law on July 21, 2004 "to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures (vaccines). The Public Readiness and Emergency Preparedness (PREP) Act slipped under the radar when George Bush signed it into law as part of the 2006 Defense Appropriations Act (HR 2863). It lets the HHS Secretary declare any disease an epidemic or national emergency requiring mandatory vaccinations. Nothing in the Act lists criteria that warrant a threat. Also potential penalties aren't specified for those who balk, but very likely they'd include quarantine and possible fines. Comm. No. Ref. To: Ref. Date Bf:T 21 ~pp9 10/19/2009 As with all medical interventions swine flu vaccines forces one to look at the trade-offs of benefits vs safety vs alternatives. Each intervention should be considered on its own since medical effects are so often hard to predict. About the only thing we can say is that when the same process of vaccine preparation is done on a new product there should be no unusual contaminants or unexpected allergies to the background material. Still the new virus itself needs to be considered novel. The ultimate evaluation of safety and efficacy will be observational, empirical. This means give the shots and watch to see what happens - rather than try to make predictions based on theories or surrogate markers. First, it is a little strange to hear on the news that health officials are guaranteeing "safety". Two problems with statements like these are that nothing is ever totally safe. Secondly to show near total safety (even if it theoretically did exist) would require studying hundreds of thousands of subjects prior to marketing. We don't have the time for huge studies as the swine flu is spreading too rapidly. So we are forced to release it without a complete evaluation of safety - but is this partial evaluation good enough? "Good enough" means that we look at the benefits vs safety vs alternatives as mentioned previously. First the benefits: For population of 100,000, based on what we have seen so far in the US swine flu is predicted to eventually infect half (50,000). Of this we expect about 250 deaths (half a percent). The vaccine is about 95% effective so if everyone were vaccinated only 12 deaths would occur, a reduction of 238. Most of these predictions are based on observations, not theories. The safety: Before it was released the best I can tell is that the vaccine was tested in 2400 people, with no serious side effects or deaths seen. Because the number of subjects is not huge there is an associated uncertainty with this zero rate of serious effects /death. The 95 % confidence interval is (0 - .15%), which correlates to 0-150 per 100,000. Let us be "conservative" and worse case the side effects to say it might be 150. The alternatives: Despite massive efforts at education to prevent illness swine flu continues its rapid spread. Tamiflu is looking to be more and more ineffective unless given very early in the course of the illness - something quite impractical. The alternatives are an order of magnitude worse than the vaccine. Bottom line is for 100,000 people would you give a vaccine which in the worse case results in 150 severe side effects to prevent 238 swine flu deaths? Yes, the benefits outweigh the side effects. Note: 1) So far this argument applies to the general population with a death rate from swine flu of 5 per 1000. If you look at high risk groups (underlying disease or pregnancy) the death rate is much higher and the benefit to safety argument favor even more the giving of the vaccine. 2) Arguments of thimerisol toxicity, method of production, even adjuvants (which have not been used) etc, etc. are all covered by the observation of the 2400 vaccinated. We saw no severe side effects (I'm going to trust that we are not lied to on this point) . Furthermore these 2400 were monitored for several weeks - when all the rapid onset side effects (including Guillain_Barre) would show. The only thing which we might miss are the late side effects (slow virus - which should be killed since we use the same processing as seasonal flu vaccine and late occurring birth defects). 3) The situation in 1976 will show that the risk of serious side effects (Guillain- Barre) of 12 per million to that vaccine outweighed the benefits. This is because even if the side effect rate was very low, the transmission of Swine flu in 1976 (outside or the Army base) was near zero, nearly no benefits. With no benefits even low rates of side effects imply that we should not give the vaccine. Note that testing of "only" 2400 this year could "miss" detecting this low rate of side effects BUT because the 2009 benefits are so large we don't care about teasing out the rates of side effects that are this low. 4) The "benefits" might be to the individual or to society. When the individual benefits are below the risks of side effects - but one is asked to take the vaccine to protect the public - then we have moral dilemma. In this case I, personally could not force anyone to take the vaccine. I could deny unvaccinated staff to come to work since unvaccinated staff could put the public at risk. I believe that by the time mandatory vaccines are even envisioned the personal and the public benefit EACH will far outweigh the risk. This is especially true if the swine flu turns more deadly.