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Front Page » Law » Congress » The 21st Century Cures Act: Say Goodbye to Vaccine Safety Science
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The 21st Century Cures Act: Say Goodbye to Vaccine Safety Science

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

First, the 21st Century Cures Act allows the FDA to expedite licensure63 64 of new vaccines and expand uses for existing vaccines65 based on:

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).
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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….”.
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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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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 Challenge? Frontiers in Microbiology 2011; 2(124).
58 Michigan State University. Vaccine Developed for E.Coli Diarrheal Diseases That Kill Millions of Children. Science Daily Apr. 14, 2009.
59 Cashin-Garbutt A. Norovirus vaccines: an interview with Dr. Benjamin Lopman, Centers for Disease Control and Prevention. News Medical July 28, 2014.
60 Fletcher HA, Hawkridge T, McShane H. A New Vaccine for Tuberculosis: The Challenges, Development and Deployment. Journal of Bioethical Inquiry 2009; 6(2): 219-228.
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.
69 Hudgens NG, Gilbert PB, Self SG. Endpoints in vaccine trials. Statistical Methods in Medical Research 2004; 13: 1-26.
70 U.S. House of Representatives. 21st Century Cures Act. Sec. 2021. Qualifications and Use of Drug Development Tool. (9) Surrogate Endpoint (A) and (B). Pg. 86. July 2, 2015.
71 Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Apr. 4, 1997.
72 Fisher BL. The Moral Right to Conscientious, Philosophical and Personal Belief Exemption to Vaccination. Presentation to National Vaccine Advisory Committee May 2, 1997.
73 Nir E. Informed Consent. The Stanford Encyclopedia of Philosophy 2011 (Fall Edition).
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75  Avorn J, Kesselheim AS. The 21st Century Cures Act – Will It Take Us Back in Time? N Engl J Med 2015; 372(26): 2473-2475.
76  Jefferson T. Influenza vaccination: policy versus evidence. BMJ 2006; 333(7574): 912-915.
77 Jacobsen RM, Targonski PV, Poland GA. Why is evidence-based medicine so harsh on vaccines? Why is evidence-based medicine so harsh on vaccines? An exploration of the method and its natural biases. Vaccine 2007; 25(16): 3165-3169.
78 Osterholm M, Kelley NS et al. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. The Lancet 2012; 12(1): 36-44.
79 Every-Palmer S, Howick J. How evidence-based medicine is failing due to biased trials and selective publication. Journal of Evaluation in Clinical Practice 2014; 908-914.
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29 Responses to The 21st Century Cures Act: Say Goodbye to Vaccine Safety Science

  1. Andrew Wise Williams Reply

    January 10, 2016 at 5:23 pm

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  2. owldog Reply

    August 20, 2015 at 6:18 pm

    They tried to do that “no exception” deal in Oregon. I sent a letter to the editor about the fact that people disenchanted by vaccines, on account of adverse side effect experiences won’t be coerced, and will home school. In Oregon, schools are funded by the state, and the amount each school gets is based on how many students they have. They get an establish amount for each student enrolled. Home schooled students need to be registered with the State. So more registered home schooling students means less money for the school.

    I guess somebody was listening because the Oregon legislator put it on the back burner and forgot about it.

  3. owldog Reply

    August 20, 2015 at 5:36 pm

    Computer modeling to prove the safety of vaccines?
    We used to call that “fuzzy math.”

  4. Cynthia Keener Reply

    August 20, 2015 at 1:42 pm

    Okay so I’m not even reading this through right now. My first reaction is great then the probability of vaccine damage & death doesn’t need a scientific leg to stand on. Read the Vaccine Injury & Death Reports something had to be proven somewhere to link vaccines to injury or death. Yet they keep saying this is all safe? This is simply a common sense type of issue here no degree needed. Lastly great medical marijuana (CBD) should also fall under this are of non testing. They say there hasn’t been enough testing on CBD oils to know it’s safety, lol. When a child has Dryvet syndrome having up to 500 seizures a day & the only thing that helps w/out horrible side effect is CBD there’s the evidence! Charlotte & Zachai’s journey see on YouTube:)

  5. April Tatro-Medlin Reply

    August 20, 2015 at 12:52 pm

    I think they are doing this in California to push kids into virtual charters & destroy the public education system while profitting from vaccines at the same time. In Nevada & CA the industrial grade wi- fi upgrades in schools is having the same effect- destroying public education & pushing kids sick from microwave emissions out to the virtual charters. Hedge Funds are invested in the charters. In NV education funds now follow the student.See “Tip of the Iceberg: Charter School Vulnerabilities to Waste, Fraud, & Abuse” report.Many kids are leaving public schools because of bullying.Look for common individuals on boards of vaccine companies & virtual charters.

  6. Bet Reply

    August 20, 2015 at 11:20 am

    Please join us as we generate a new paradigm of TRUTH, TRANSPARENCY, PEACE, CHOICE and HOPE within our regulatory agencies starting with the CDCcrimes! In addition to our rally-happenings, this day, we will stand united to call for Dr William Thompson to come forth with the truth.

    DAY 1:
    Friday, October 23rd
    2-6 p.m.

    CDC headquarters
    1600 Clifton Road, Atlanta, GA

    DAY 2:
    Various Events
    Saturday, October 24th
    Time: TBA

    Grant Park
    840 Cherokee Ave SE, Atlanta, GA


    Dr. Brian Hooker

    Robert F. Kennedy Jr.

    Dr. Toni Bark

    Marcella Piper-Terry

    Eric Gladen of MandateTheTruth.org

    Alison Folmar

    Singer Stacy Francis will be performing.

    DAY 3:
    Sunday, October 25th
    Time: TBA


  7. Colorado Reply

    August 20, 2015 at 10:51 am

    Recall and sanction the politicians whom supported mandatory vaccination bills. Successful recall efforts in a single state, have national influence. If people want to stop this hijacking of representative governance, they should argue that paid lobbying of government persons should be illegal, and/or that no government politician can ever hold a job as a lobbyist later. Put your money where your mouth is, and give at least a $100 donation to the NVIC.

  8. mary jones Reply

    August 20, 2015 at 9:16 am

    So reckless, so immoral! I fear for every child born in this country.

  9. Mary Mills Reply

    August 20, 2015 at 9:09 am

    Perhaps every CDC employee, congressman and government official (including the president) and there spouses and children be required to be vaccinated with every single vaccine that is mandated for the use in the United States. Maybe the lawmakers will look a little closer at potential harm and lack of good science. Let’s see who yells the loudest when a vaccine makes them or their loved ones sick or heaven forbid dies. It happens more than anyone knows as many doctors do not report injuries or deaths attributed to vaccines – this is a fact.

  10. Brigett Si Reply

    August 20, 2015 at 9:03 am

    Its kind weird how We can sue a doctor if you from somebody but we can’t sue a doctor forgiving are child bad shots unbelievable

  11. Melissa Forrest-Garcia Reply

    August 17, 2015 at 3:04 pm

    Please help us get the word out! In California, we are gathering signatures for the SB277 Referendum to Halt the Bill from going into effect! There is a short training video and I can help you get some petitions if you want to join the effort to stop SB277, the mandatory vaccination bill that takes away Parental Consent! Not to mention the religious and Personal belief exemptions. Comment below if you want to sign the petition.

    • Sara Mullen Reply

      August 20, 2015 at 3:58 pm

      Hi Melissa, Do you need to be a California resident to sign? If not, I’ll sign it. I have a nephew out there I worry about, especially since both my twins regressed into autism after vaccinations. Plus, anything that could halt this craziness before it spreads to other states, I’m all for.

      If things keep going south out there, consider moving to CO. We already have so many transplants that come for legal marijuana and tech jobs. We may as well have some vaccine aware people coming in for the vaccine exemptions. Then we’ll have that many more people on the front lines working to keep them.

      In the meantime though I really hope it doesn’t come to that and that you guys secure a victory out there and defeat this thing. My heart is with you.

  12. Munoz Reply

    August 17, 2015 at 12:16 pm

    In the Nuremberg Code voluntary consent of the human subject is absolutely essential, especially in regards to experiments, which, if the vaccines have no science behind them, means that anyone receiving a vaccine has become the subject of that experiment.

  13. Louise Kerr Reply

    August 17, 2015 at 10:06 am

    The truth has to be carefully worded. Best to avoid vaccinations.

  14. Louise Kerr Reply

    August 17, 2015 at 10:04 am

    Like GMO’s, experimenting on people.

  15. Louise Kerr Reply

    August 17, 2015 at 10:03 am

    It may be just another attempt at population control.

  16. Patrck McGean Reply

    August 17, 2015 at 7:50 am

    The First Amendment to the Constitution is the freedom of speech, just say no to any vaccine. Never safe nor never effective, Just say no and carry a big gun, when a vaccinator reaches for you or your child, shoot them dead. 2nd Amendment gives us the right to own the gun with which we shoot these pedophiles. Regarding the Boston Tea Party, destroy the hypodermic needles and we can address the needle and the damage done. Neil Young.

    Anyone who believes vaccines are good may die on my watch, Teacher Leave those kids alone or we will end your miserable lives.

    • Bozewell Reply

      August 20, 2015 at 9:06 am

      Wow Patrick…….I agree with you. Been talking about getting a gun for years and Big Pharma is pushing me closer. This monster is just getting bigger and if Congress is going to be part of this monster than we must rise and defeat for the salivation of mankind.

      Perhaps if every member of Congress was to get an independent video vaccination…………….

  17. Lowell Reply

    August 16, 2015 at 9:52 pm

    I have a website, and there is more vaccine truth and learning to be had there, than you can likely review it all, in a months time.


    • Kelly Reply

      August 23, 2015 at 2:38 pm

      Great website, Ive added it to my favorites bar! Thanks!

  18. DR Richard Muccillo Reply

    August 16, 2015 at 1:06 pm

    Time for a revolution –like the Boston tea party

  19. MAXINE HAYES Reply

    August 16, 2015 at 10:48 am

    I don’t have a website, but I have an email. I think that we need to rise up and strike out this 1986 law. We need to have tighter restrictions on vaccines, not any at all. This has to be fixed.

  20. Shirley De Reply

    August 16, 2015 at 8:47 am


    Will the World Population go along with it or resist it?

  21. Susan Reply

    August 15, 2015 at 5:54 pm

    This legislation will further divorce doctors and hospitals from the trust of patients. The face of conventional American healthcare has forever changed. It has been dead for years. Now we will see it fall over. The transition will be long and painful.

  22. Num Guy Reply

    August 15, 2015 at 10:26 am

    Sadly, vaccine makers have no incentive to change their ways. They make huge profits but are totally protected from lawsuits because Congress granted them immunity in 1986. Families are paying for the damages vaccines are causing. If you want to change this, please sign this petition

    Protect kids, not drug makers!The law is corrupt and immoral.

  23. Silvia Chamlee Reply

    August 14, 2015 at 8:04 pm

    This cannot happen.

    We should not be made into human lab rats , so corporations can ride a mandated train of profit.

    • cathy Reply

      August 16, 2015 at 2:51 pm

      We already are lab rats and have been for years. It is how we got into this mess. 100 years, since the FED (Fed. Res. Banking System) took control of the United States’ money supply (yes, it wasn’t always like that. It is what the Revolution was for) we have been brainwashed, used as lab rats for the purpose of making profit by making and keeping people sick. This country is so messed up…

  24. Eric H Reply

    August 14, 2015 at 8:03 pm

    From insufficient studies to virtually none.

    • Linda Reply

      August 20, 2015 at 5:19 pm

      So so corrupt

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