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
Bill Lowers FDA Licensing Standards
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
Greasing Skids to License Drugs and Vaccines
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
Ensuring Drugs & Vaccines Dominate U.S. Health Care
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
Faster Track for Vaccines You Will Have To Take in Future
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
Gutting Informed Consent Along with Science
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.
Using “Best Guess” Statistics Instead of Good Science
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.
Congress and Pharma: Friends with Benefits
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.
A Consumer’s Worst Nightmare
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.
10 Hodsden S. 21st Century Cures Act Set to Overhaul FDA Regulatory Process. MedDevice Online July 10, 2015.
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.
16 Kabesch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized Controlled Trials. Dtsch Arztebl Int 2011; 108 (39): 663-668.
17 Sibbald B, Roland M. Understanding controlled trials: Why are randomized controlled trials important? BMJ 1999; 316: 201.
18 Clinicaltrials.gov. Vaccine Clinical Trials.
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.
21 Belluz. J. This new bill would add $9 billion for medical research. Here are 5 reasons why critics are terrified. Vox July 14, 2015.
22 Fisher BL. Public Perspective on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Institute of Medicine Feb. 9, 2012.
23 Tomlijenovic L, Shaw CA. Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds? Annals of Medicine 2013; 45(2): 182-193.
24 Goldman A. Scientific consensus finds the HPV vaccine safe. Women’s Health Dec. 6, 2013.
25 English K. Public editor criticizes the Star’s Gardasil story. The Star Feb. 13, 2015.
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.
27 National Vaccine Information Center. Merck’s Gardasil Vaccine Not Proven Safe for Little Girls: National Vaccine Information Center Criticizes FDA for Fast Tracking Licensure. NVIC Press Release June 27, 2006.
28 Zimm A, Preston D. Merck Gets First U.S. Cancer-Shot Mandate, From Texas. Bloomberg News Feb. 2, 2007.
29 Gardner A. Drugmaker Assists in Pushing for Mandate for HPV Vaccination. Washington Post Feb. 11, 2007.
30 Immunization Act Coalition. HPV Vaccine Mandates for Children in Secondary Schools. Feb. 2, 2015.
31 National Conference of State Legislatures. HPV Vaccine Legislation (2006-2015). June 2015.
32 Centers for Disease Control (CDC). Recommended schedule for active immunization of normal infants and children 1983.
33 American Academy of Pediatrics (AAP).Policy Statement – Increasing Immunization Coverage. Pediatrics 2010; 125(6): 1295-1304.
34 CDC. Recommended Immunization Schedule for Persons Aged 0 Through 18 Years – United States, 2015.
35 CDC. Vaccines and Immunizations: State Vaccination Requirements. Apr. 7, 2015.
36 NVIC. org. State Law and Vaccine Requirements.
37 CDC. Recommended Adult Immunization Schedule – United States, 2015.
38 Fisher, BL. Women, Vaccines & Bodily Integrity. NVIC Newsletter Jan. 14, 2013.
39 Wrangham T. Adults Targeted as Federal Government Prepares to Track the Unvaccinated. NVIC Newsletter Mar. 18, 2015.
40 DHHS. About the Affordable Care Act Law. Nov. 14, 2014.
41 Hamburger T. Obama gives a powerful drug lobby a seat at healthcare table. Los Angeles Times Aug. 4, 2009.
42 The Medicare Newsgroup. What Is the Pharmaceutical Research and Manufacturers of America (PhRMA) and How Is It Involved in Lobbying for Health Care Reform?
43 Milne CP, Kaitlin KI. Impact of the New US Health-Care-Reform Legislation on the Pharmaceutical Industry: Who Are the Real Winners? Clin Pharmacol Ther 2010; 88(5): 589-592.
44 DHHS. Preventive Services Covered Under the Affordable Care Act. Sept. 27, 2012.
45 Coleman K, Geneson J. Drug coverage & the Affordable Care Act: 34% increase in drug copayments and coinsurance fees compared to the pre-reform market. Health Pocket Feb. 13, 2014.
46 Tan LJ. Vaccine Financing, the Affordable Care Act (ACA) and Immunizations. National Adult and Influenza Immunization Summit May 12, 2015.
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.
49 National Institutes of Health (NIH). HIV Vaccine Research. NIAID June 8, 2015.
50 HIV Vaccine Trials Network. An HIV Vaccine: The World’s Best Long Term Hope for Ending AIDS. What’s Next for HIV Vaccines: From Design to Efficacy Testing. July 19, 2015.
51 NIH. Dr. Fauci at IAS 2015: Comprehensive global prevention can end HIV/AIDS pandemic. EurekAlert! July 21, 2015.
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.
54 Swadling L, Capone S, Antrobus RD et al. A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory. Science Translational Medicine 2014; 6(26).
55 NIH. NIH launches trial of investigative genital herpes vaccine. NIAID Press Release Nov. 8, 2013.
56 Cameron CE, Lukehart SA. Current status of syphilis vaccine development: Need, challenges, prospects. Vaccine 2014; 32(14): 1602-1609.
57 Zhu W, Chen CJ, Thomas CE et al. Vaccines for Gonorrhea: Can We Rise to the Chall