The 21st Century Cures Act: Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

The 21st Century Cures Act: Say Goodbye to Vaccine Safety Science

by Barbara Loe Fisher

Published August 13, 2015 | Law, Congress

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The bill allows the FDA to lower licensing standards for testing of experimental drugs, medical devices and “biological products”—a category that includes vaccines—so companies will no longer be required to conduct large, case controlled clinical trials to evaluate safety and effectiveness.

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 government^{3 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 vaccines^{13 14 15} —so companies will no longer be required to conduct large, case controlled clinical trials^{16 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 21^st 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 21^st 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 21^st 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 21^st Century Cures Act allows the FDA to expedite licensure^{63 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 consent^{71 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 trials^{76 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 plants^{91 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 21^st Century Cures Act is a prescription for disaster. Vaccine research, development and fast tracking should not be a part of it.

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