Published August 17, 2016
On Feb. 22, 2016, the White House submitted to the U.S. Congress a $1.9 billion emergency supplemental appropriations request from...
— William Wilberforce
It has only been a few weeks since the forced vaccination lobby rammed a bill (SB 277) through the California legislature eliminating the personal belief vaccine exemption so children will have to get dozens of doses of federally recommended vaccines or be denied a school education.1 While California was being subjected to one of the most aggressive and expensive state lobbying campaigns2 ever mounted by the pharmaceutical industry in partnership with medical trade associations funded by industry and government3 4 5 6 that same lobby was pulling an even bigger fast one on the American people in Washington, D.C.
Here comes the 21st Century Cures Act,7 which is a Pharma-driven bill8 blessed by the FDA9 that seriously compromises the integrity of the FDA drug and vaccine licensing process.10 The 362-page bill sailed through the U.S. House of Representatives on July 10, 201511 and mandates that about $9 billion dollars be given to NIH to develop more drugs and vaccines and $550 million be given to the FDA to fast track products to market.12
The bill allows the FDA to lower licensing standards for testing of experimental drugs, medical devices and “biological products”—a category that includes vaccines13 14 15 —so companies will no longer be required to conduct large, case controlled clinical trials16 17 18 to evaluate safety and effectiveness. Instead, FDA can accept novel statistical analyses 19 and “clinical experience,”20 such as anecdotal evidence from patients.21
It is interesting that clinical experience and anecdotal evidence will constitute “good science” for the purpose of demonstrating a vaccine is safe before it is licensed, while clinical experience and anecdotal evidence has never been good enough to demonstrate that a vaccine is unsafe after it is licensed.22 23 24 25
The 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.26 However, greasing the FDA licensure skids to make experimental drugs available for the sick and dying, who voluntarily choose to use them, is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use, is something quite different.27 28 29 30 31
Nearly every single vaccine that the pharmaceutical industry creates and the FDA licenses for child use is eventually recommended for all children and mandated by state governments for daycare and school entry.32 33 34 35 36 And, now, many adults are being brought into the vaccine mandate net as well.37 38 39
Coming on the heels of the Affordable Health Care Act,40 which guaranteed that the pharmaceutical industry and their products will continue to dominate the most expensive health care system in the world,41 42 43 44 45 46 there are so many breathtaking ways the 21st Century Cures Act will endanger the public health that it is hard to know where to begin. The word “vaccines” is not being publicly uttered by anyone sponsoring the bill. However, the Biotechnology Industry Organization (BIO), which represents more than 1,500 pharmaceutical and other health product corporations, is already crowing about how they managed to influence Capitol Hill politicians to incorporate the “Vaccine Access, Certainty and Innovation Act of 2015” into the 21st Century Cures Act.47 48
So, if the Senate approves and the President signs this life-threatening bill into law by the end of this year, what will happen to the hundreds of experimental vaccines that will be fast tracked to licensure and mandated for you and your children to get in the future? Just so you know, that list includes vaccines for HIV/AIDS,49 50 51 chlamydia,52 cytomegalovirus,53 hepatitis C,54 genital herpes,55 syphilis,56 gonorrhea,57 e-coli,58 norovirus,59 tuberculosis60 and many, many more.61 62
1. Shorter or smaller clinical trials; and
2. non-traditional or adaptive trial designs and Bayesian methods of data analysis;66 and
3. evidence from clinical experience instead of randomized, controlled clinical trials;67 68 and
4. use of biomarkers and surrogate endpoint measures69 rather than actual clinical endpoints proving effectiveness.70
Second, the new law would allow researchers to conduct “clinical testing” of experimental pharmaceutical products on people without first obtaining their informed consent71 72 73 if “the proposed clinical testing poses no more then minimal risk.”74 75 It is not clear who decides what constitutes “minimal risk,” but presumably that will be left up to industry and government officials. It is also not clear whether minor children can be enrolled in experiments without the informed consent of their parents.
Just for fun, I looked up the definition of Bayesian to see what will happen if the FDA lets drug companies use that method instead of large randomized clinical trials76 77 78 79 80 to determine whether an experimental vaccine is safe or not. Here is what the dictionary says about Bayesian:
Being, relating to, or involving statistical methods that assign probabilities or distributions to events or parameters based on experience or best guesses before experimentation and data collection and that apply Bayes’ theorem to revise the probabilities and distributions after obtaining experimental data.81
The key phrase to focus on is “based on experience or best guesses before experimentation or data collection.” While we know federal agencies have been guessing for a long time when it comes to pronouncing vaccines safe and effective due to long standing gaps in vaccine safety science,82 83 84 85 86 it is irresponsible for Congress to bow to Big Pharma and codify into law the legal right for FDA officials to use flimsy “best guess” statistical methods and unreliable surrogate endpoints to support claims that a new vaccine is safe and really works, instead of requiring vaccine manufacturers to conduct in-depth biological mechanism research and large, well-designed clinical trials.
Moving numbers around in a computer is a poor substitute for actually proving an experimental vaccine does not kill and injure real human beings before it is licensed.
In 1986, Congress allowed itself to be blackmailed by the pharmaceutical industry and removed most civil product liability from vaccine manufacturers87 and, in 2011, the U.S. Supreme Court declared vaccines to be “unavoidably unsafe” and completely removed all product liability from FDA licensed vaccines.88 89 90 In America, nobody can sue drug companies when FDA licensed vaccines injure and kill people.
Not satisfied with a total product liability shield and with access to billions of dollars in American taxpayer money to build new vaccine plants91 92 93 and create hundreds of new vaccines,94 95 96 while getting government-paid free advertising97 and enjoying a predictable market from “no exceptions” vaccine mandates, the pharmaceutical industry is now insisting that Congress give them a free pass on the science, too.
The financial public private partnership that Congress has directed government to forge with industry through a series of federal laws created over the past 30 years,98 99 100 101 102 103 104 105 106 is a drug company stockholder’s dream and a consumer’s worst nightmare. That lucrative partnership, which is using the “greater good” club to violate the human and civil rights of the American people in the name of a highly politicized “War on Disease,” has the potential to destroy more lives than any war our nation has ever fought.
The 21st Century Cures Act is a prescription for disaster. Vaccine research, development and fast tracking should not be a part of it.
1 Fisher BL. California Enacts Vaccine Law That Forces Law Forces Parents to Choose Between Human Rights and Civil Rights. NVIC Newslettter July 1, 2015.
2 Miller J. Drug companies donated millions to California lawmakers before vaccine debate. The Sacramento Bee June 18, 2015.
3 Biocom. Membership List 2015 that includes Pfizer, Merck, GSK, Novartis, Sanofi, Monsanto, Kaiser Permanente and support for state legislation of interest (SB 277).
4 California Immunization Coalition, a project of the Immunization Action Coalition that is funded by Astra Zeneca, BioCSL, Merck, Novartis Vaccines, Pfizer and Sanofi Pasteur and CDC.
5 American Academy of Pediatrics, California chapter. AAP is funded by the pharmaceutical industry.
6 California Medical Association. California Medical Association Foundation corporate sponsors include Pfizer, Astra Zeneca, Lilly and Kaiser Permanente.
7 U.S. House of Representatives. 21st Century Cures Act (July 2, 2015).
8 Lazar A. PhRMA companies push hard on House bill to ease testing of new drugs. Open Secrets June 16, 2015.
9 Woodcock J. 21st Century Cures: Modernizing Clinical Trials and Incorporating Patient Perspective. Testimony for Subcommitee on Health, Committee on Energy and Commerce, U.S. House of Representatives July 11, 2014.
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11 Clarke T. U.S. House passes ‘C21st Cures’ bill to speed new drugs to market. Reuters July 10, 2015.
12 Ross S. House overwhelmingly passes 21st Century Cures Act. Modern Healthcare July 10, 2015.
13 Federal Food, Drug and Cosmetic Act. 42USC262. Sec. 262. Regulation of Biological Products. (i) Biological product defined. The term ”biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product… applicable to the prevention, treatment, or cure of a disease or condition of human beings.
14 U.S. Public Health Service Act. Part F – Licensing- Biological Products and Clinical Laboratories. Subpart 1 – Regulation of Biological Products. Sec. 351,Pg. 282. The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, protein….”.
15 H.R. 6 – The 21st Century Cures Act. (2) Use of a Drug Development Tool (A) and (B). Pg. 80. July 2, 2015.
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19 U.S. House of Representatives. 21st Century Cures Act. Subtitle D – Modern Trial Design and Evidence Development. Broader Application of Bayesian Statistics and Adaptive Trial Designs. Pg. 97-98. July 2, 2015.
20 U.S. House of Representatives. 21st Century Cures Act. Sec. 2062. Utilizing Evidence from Clinical Experience. Pg. 100-101. July 2, 2015.
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26 U.S. House of Representatives. 21st Century Cures Act. Subtitle E – Expediting Patient Access. Sec. 2081 – Sense of Congress. Pg. 111-112. July 2, 2015.
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47 Biotechnology Industry Organization. BIO Praises Vaccine Access, Certainty, and Innovation Act of 2015. BIO Press Release Feb. 6, 2015. List of BIO members, including AstraZeneca, BioCSL, GlaxoSmithKline, Johnson & Johnson, MedImmune, Merck, Monsanto, Novartis, Pfizer, Sanofi Pasteur.
48 U.S. House of Representatives. 21st Century Cures Act. Subtitle H – Vaccine Access, Certainty, and Innovation. Sec. 2131 – Timely Review of Vaccines by the Advisory Committee on Immunization Practices. Sec. 2142 – Review of Processes and Consistency of ACIP Recommendations. Sec. 2143 – Meetings Between CDC and Vaccine Developers. Pg. 152-158. July 2, 2015.
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52 Harvard Medical School. Safeguarding against chlamydia: vaccine generates double protection in animals. Science Daily June 18, 2015.
53 University of California – Davis Health System. Novel vaccine approach to human cytomegalovirus found effective. Science Daily Sept. 18, 2013.
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61 Fisher BL. Vaccination Costs Increasing. Reforming Vaccine Policy & Law: A Guide. National Vaccine Information Center (NVIC) 2014.
62 Fisher BL. Many New Live Virus and Virus Vectored Vaccines Coming Soon. Pg. 11. The Emerging Risks of Live Virus and Virus Vectored Vaccines: Vaccine Strain Virus Infection, Shedding and Transmission. National Vaccine Information Center (NVIC) 2014.
63 U.S. House of Representatives. 21st Century Cures Act. Sec. 592. Precision Medicine Regarding Orphan Drug and Expedited Approval Programs. Pg. 95-96. July 2, 2015.
64 U.S. House of Representatives. 21st Century Cures Act. Sec. 2063. Streamlined Data Review Program. Pg. 107-108. July 2, 2015.
65 U.S. House of Representatives. 21st Century Cures Act. Subtitle H – Vaccine Access, Certainty, and Innovation. Sec. 2131 – Timely Review of Vaccines by the Advisory Committee on Immunization Practices. Sec. 2142 – Review of Processes and Consistency of ACIP Recommendations. Sec. 2143 – Meetings Between CDC and Vaccine Developers. Pg. 152-158. July 2, 2015.
66 U.S. House of Representatives. 21st Century Cures Act. Subtitle D – Modern Trial Design and Evidence Development. Broader Application of Bayesian Statistics and Adaptive Trial Designs. Pg. 97-98. July 2, 2015.
67 U.S. House of Representatives. 21st Century Cures Act. Sec. 2062. Utilizing Evidence from Clinical Experience. Pg. 100-101. July 2, 2015.
68 Federal Food, Drug & Cosmetic Act Chapter V Sec. 505 (b) (21 U.S.C. 355c) Research into pediatric uses for drugs and biological products.
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