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natural barrier and has been shown to produce increasedinfections in animals and humans. Such was the case when SV 40was injected intramuscularly in contaminated Salk polio vaccine.Later it was learned that Sabin's orally administered poliovaccines were safer since the live simian viruses were digested inthe stomach and thereby inactivated. Additionally risky, when itcomes to breaking the skin barrier, is the chance of transmittingviruses from one person to another through the use of unsterilizedneedles.Second is the unique and natural viral surface characteristics thatreduce the chance that viruses might jump species. The mixing ofvaccine viruses with others found in the cells and tissues used todevelop the vaccine can potentially lead to the development ofnew recombinant mutants that are more adaptive and have widerhost range than either of the original viruses. This can especiallyhappen when a live viral vaccine produced in cells from onespecies is then given to another species.Also of concern is the transmission of new ge<strong>net</strong>ic informationalong with the vaccine virus. For instance, early adenoviralvaccines, produced in rhesus monkeys' kidney cells, developed toprotect people against respiratory infections, incorporated partsof the SV40 virus that remained as a vaccine contaminant evenafter production of the vaccine virus was switched to humancells. Numerous other vaccines, especially those that were usedin early field trials in Africa, should be analyzed for those ge<strong>net</strong>iccomponents which characterize today's monkey and humanpathogens.Unfortunately, this new awareness of potential problems withlive viral vaccines has had little impact on the viral vaccineapproval process. Seemingly, U.S. government agencies,principally the FDA, have been reluctant to impose additionaltesting requirements on vaccines once they are approved for use.In effect, government officials are given a single opportunity todecide on a new vaccine's safety. Even then, governmentregulators themselves may be denied certain critical informationbelonging to the vaccine industry. Specifically, FDA regulationsare written so as not to compel industry to reveal testinginformation not directly pertaining to the lots submitted forclinical use. The FDA is reluctant to admit its lack of knowledgeabout vaccines to the medical/scientific community. Yet,practicing physicians are expected to unquestionably endorse thesafety of vaccines under all circumstances and to all individuals.Aside from these bureaucratic barriers to viral vaccine safetyassurance, there are additional major concerns. Since vaccinedevelopment information is considered proprietary - protected bynondisclosure policies - government officials and researchersmust shield potential safety issues from public scrutiny. Thiscensorship is rationalized by the all too persuasive argument thatvaccines cannot be criticized lest the public become noncompliantin taking them. Finally, this silence is buttressed by thesmall number of people capable of critically evaluating vaccine
manufacturing and safety testing procedures. In essence, healthcare professionals and the general public know little about thepossible dangers of live viral vaccines.As an illustration, the issue of possible simian cytomegalovirus(SCMV) contamination of live polio virus vaccines has beensuppressed since 1972. On the eve of Nixon's war on cancer, ajoint Lederle Corporation/FDA Bureau of Biologics studyshowed that eleven test monkeys, imported for polio vaccineproduction, tested positively for SCMV. The reluctance of theFDA to act on this matter was revealed in a corporate memodelivered the following year. Even in 1995, following a report toFDA officials concerning a patient infected with a SCMVderivedvirus, no new in-house testing of polio vaccines forSCMV has occurred. Moreover, this author's specific requests forvaccine material to undertake specific testing, were denied on thebasis of protecting "proprietary" interests.This basic flaw in the regulatory process must be addressed - theFDA must be responsive to the medical-scientific community'sneed for accurate information regarding the potential hazards ofproducts released for use in society. In the event that publichealth and safety concerns arise, industry should wave its right tomaintain proprietary intelligence. This would enable the FDA todisclose more information concerning the safety of FDAregulated products to the medical-scientific community. Such aproposal should be included in the all pending and future FDAreforms.It is against this background of possible risks of past viral vaccinestudies, uncertain biological recombinants, bureaucraticcensorship, a rising tide of medical consumerism in theinformation age, and an urgent need for legislative FDA reform,that Dr. Horowitz's work contributes. At mini-mum, what you are about to read exposes many important factswhich, unfortunately, few people realize and all would be betteroff knowing. At best, this important text raises far greater hopethat by knowing their origin, cures for the many complexemerging viruses, including AIDS, may be forthcoming.-W. JOHN MARnN, M.D., Ph.D.** Dr. W. John Martin, a Professor of Pathology at the Universityof Southern California, is also the Director of the Center forComplex Infectious Diseases in Rosemead, California. Between1976 and 1980, Dr. Martin served as the director of the ViralOncology Branch of the FDA's Bureau of Biologics (now theCenter for Biologics, Evaluation and Research), the government'sprincipal agency in charge of human vaccines.Prologue
Page 2 and 3: EMERGING VIRUSES: AIDS &EBOLANature
Page 4 and 5: inherent in the production of live
Page 8 and 9: "DAVID was an alcoholic, an active
Page 10 and 11: mass of circumstantial and scientif
Page 12 and 13: investigators, for a grossly uninfo
Page 14 and 15: NIAID-National Institute for Allerg
Page 16 and 17: Part IIntroduction and Scientific B
Page 18 and 19: viruses in the cow carcasses used t
Page 20 and 21: depend to maintain our relative fre
Page 22 and 23: ʺThe WHO Does What?ʺ"The only thi
Page 24 and 25: the buildup of new susceptibles in
Page 26 and 27: In 1964, shortly after President Ke
Page 28 and 29: lymphotrophic (lymph-cell-targeting
Page 30 and 31: immunological and therapeutic proce
Page 32 and 33: substances used in the diagnosis of
Page 34 and 35: Chronicle 1969;23;3:112-117.[20] Si
Page 36 and 37: In February 1967, as international
Page 38 and 39: experiments conducted at Porton, En
Page 40 and 41: technique, weapon, tactic, or strat
Page 42 and 43: mankind in general, require that th
Page 44 and 45: experimental studies is to be comme
Page 46 and 47: the virus genome, the genetic makeu
Page 48 and 49: [17] Horowitz LG and Kehoe L. Fear
Page 50 and 51: Chapter 4The Road to Fort Detrick R
Page 52 and 53: information, I decided to call the
Page 54 and 55: contamination) to help with manufac
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nation. There is but one logical co
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each part in terms of objectives -
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weapons, and all other methods of b
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two checks totaling $33,655.68 to t
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Not surprisingly then, among the pr
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and biological warfare. Indianapoli
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Chapter 5The Emperorʹs New Virus"Y
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At that time, retroviruses were see
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it up to here with this goddamn dis
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Collusion at the TopJim Goedert was
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HTLV-III publication in Francis's p
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the footprints of a retrovirus allo
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questions. Had Gallo been ashamed o
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Chapter 6Galloʹs Research Antholog
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- - - - -Fig 6.2 - A Model of the N
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That same year, Gallo and his cowor
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team discussed the synthesis of new
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STRINGNER S. YANGROBERT C. TINGBion
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and pellets seperated. The pellets
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[5] Gallo RC and Breitman TR. The e
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Chapter 7An Interview with Dr. Robe
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human viruses, and that the genetic
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LEN: Now, who was studying that?ROB
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father's recommendation that I coul
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LEN: OK. Explain this now. Why did
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the cancer virus. . . . Nixon was t
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LEN: OK.ROBERT: And. . . that's the
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ROBERT: If you look in the world, w
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ROBERT: They're in the references [
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started with BVV.ROBERT: Well, in t
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LEN: OK. So what happens then?ROBER
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apology Gorbachev offered Reagan ac
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slowly, and not fast. And that they
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immunodeficiency virus. Nature 1987
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GalloRC. Aminoacyl Transfer RNA Pro
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history, organization, and program
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