Fwd: Safety Concerns about the of H1N1 Swine flu Vaccine & Public Policy

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTIONA Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountabilityhttp://www.ahrp.org <http://www.ahrp.org/> FYIHistory is about to repeat itself: [This is a follow up to a July 26, 2009Infomail, See: http://www.ahrp.org/cms/content/view/619/9/ ]In the 1976 swine flu vaccine program, 40 million people were vaccinatedwith an inadequately tested vaccine. The government gave the vaccinemanufacturers immunity from liability, but created an alternativecompensation program. Five thousand people sought benefits for vaccineinjuries.Today, as in 1976, official concern has focused on flu vaccine availabilitywithout regard for the safety of an H1N1 vaccine. Many national regulatoryagencies have set-up fast-track approval processes for the H1N1 vaccine,which means that a vaccine might be licensed without the usual safety andefficacy data requirements. Vaccine safety will therefore have to be monitored through post-marketingsurveillance. But there is reason for concern that we will repeat the debacle of the 1976H1N1 outbreak in the USA, where mass vaccination was associated withcomplications, which stopped the campaign and led to the withdrawal of thevaccine.What's more, today, the government has NOT established an ALTERNATIVECOMPENSATION PROGRAM--as it had in 1976. The existing vaccine compensationprogram covers only designated vaccines and does NOT cover most adultvaccines. The U.S. government has adopted (what critics regard) a reckless policyencouraging (if not mandating) the use of untested. controversial vaccineswith novel adjuvants likely to be used to strengthen vaccines and stretchthe supply--they are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline).Only 3 vaccines using these adjuvants have been licensed in Europe, and nonehave been given a license in the US. It is likely that these adjuvants will cause far more damage and autoimmuneillness than the swine vaccine used in 1976. Indeed, Manufacturers have been given immunity from liability, as have thegovernment program planners. But no compensation mechanism has been createdfor citizens who are likely to suffer harm. This is but a tacitacknowledgement that the vaccines are likely to produce harm.Below, AHRP board member, Dr. Meryl Nass summarizes the facts. She notesthat countries need to assess carefully the risks and benefits of rapidapproval of an H1N1 vaccine, especially since the disease has so far beenmild with most patients making a full recovery. They must also ensure thatthey have strong post-marketing surveillance in place before rolling out avaccine.Additional information is posted on Dr. Nass' blog,http://anthraxvaccine.blogspot.comContact: Vera Hassner Sharavveracare212-595-89741. The USG is using laws designed for dealing with a very deadly pandemicor bioterrorism to bring in a mass vaccination program for swine flu,specifically the Public Readiness and Emergency Preparedness Act 0f 2006.http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html2. This law removes liability from the manufacturer, medical practitionerswho use the product, and "government program planners" who decided on usingthe law. A suit can only be brought if the DHHS Secretary allows it, and ifthere is willful misconduct on the part of the manufacturer.This law has been invoked for swine flu drugs (tamiflu and relenza),http://edocket.access.gpo.gov/2009/pdf/E9-14412.pdf for swine flu vaccines, and for novel vaccine adjuvants (which may be usedin vaccines to stretch the supply and possibly convey broader immunity) http://edocket.access.gpo.gov/2009/pdf/E9-14948.pdf.3. If testing of these products is very limited, then the manufacturers areunlikely to become aware of their flaws, and specifically their adverseeffects. Then there can be no willful misconduct.4. Due to the fear that swine flu will cause a large outbreak once studentsreturn to schools, where the virus might rapidly spread, the US governmenthas stated that vaccine is likely to be available, and used, before clinicaltrials are completed. WHO says vaccine will be ready in September. Novartis began testing inhumans in late July, and Sanofi-Aventis and Glaxo-Smith Kline plan to starthuman testing soon. http://www.google.com/hostednews/ap/article/ALeqM5i-Qd-q3ALSGUV0tZqwFVoy1GlGfQD99TEJN81The Europeans are also planning for use before testing is completed, despitewarnsings by experts about the potential dangers of untested vaccines.http://www.google.com/hostednews/ap/article/ALeqM5iCajXBnuqbQEUf_cH4_dblpysz_gD99MCRJO15. The adjuvants likely to be used to strengthen vaccines and stretch thesupply are name MF59 (Novartis) and ASO3 (Glaxo Smith-Kline). Only 3vaccines using these adjuvants have been licensed in Europe, and none havebeen given a license in the US. Two vaccines using these adjuvants are onlyused in people above the age of 65 (Fluad-MF59), and those with seriouskidney disease (Fendrix-ASO3). Both advanced age and kidney failure weakenthe immune system, so more powerful vaccines are needed, and autoimmunity isunlikely to result from a large immune stimulant. Cervarix is the thirdEuropean vaccine using ASO3, and its safety is controversial. 6. The then-Acting DHHS Secretary issued an emergency declaration inresponse to the swine flu epidemic on April 26, 2009. This allows use ofunapproved (unlicensed) medical treatments and tests, or use of approvedtreatments for unapproved uses. According to the Congressional Research Service, on April 27, 2009, the Foodand Drug Administration issued four Emergency Use Authorizations in responseto requests from the CDC to make available certain drugs, diagnostic testsand respiratory protection devices.http://opencrs.com/document/R40560/7. Vaccines containing MF59 and ASO3 have not had emergency useauthorizations issued for them--yet. However, the government has purchased$698 million dollars' worth of these adjuvants in recent weeks. http://www.hhs.gov/news/press/2009pres/07/20090713b.htmlhttps://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspxUS and WHO officials have indicated the likelihood of their use, which isthe only way to achieve adequate amounts of vaccine for the US and worldpopulation in the fall.8. These vaccines have never been demonstrated to be safe in children,pregnant women or young adults. They have not undergone comprehensivetesting; for example, MF59 has not and will not be tested forcarcinogenicity by the manufacturer.http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm095708.pdf See page 391 re MF59 carcinogenicity testing.9. The result of the new bioterrorism laws (passed with the expectation ofuse for much more dangerous epidemics than the current swine flu), whichallow use of untested products AND give manufacturers an incentive to avoidcomprehensive testing (to avoid being found guilty of negligence and willfulmisconduct) have combined with the political imperative to provide citizensvaccines in a hurry, yielding a Perfect Storm.In the 1976 swine flu vaccine program, 40 million people were vaccinatedwith an inadequately tested vaccine. The government gave the vaccinemanufacturers immunity from liability, but created an alternativecompensation program. Five thousand people sought benefits for vaccineinjuries.Today, untested vaccines with novel adjuvants that are likely to cause moreautoimmune illness than occured in 1976 will almost certainly be used. Themanufacturers have been given immunity from liability, as have thegovernment program planners. But no compensation mechanism has beencreated. And the public has not been informed.Meryl Nass, MDMount Desert Island HospitalBar Harbor, Maine 04609W 207 288-5081 ext. 1220C 207 522-5229H 207 244-9165pager 207 818-0708http://anthraxvaccine.blogspot.comhttp://www.anthraxvaccine.org=====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.