Cures Act Kills Informed Consent
December 7, 2016
The “21st Century Cures Act” just passed the Senate and heads to Obama, who will sign it.
HR 6 – 21st Century Cures Act which looked to be dead in the water was secretly thrown into HR 34 at the last minute – a bill that was actually for tsunami detection, forecast, warning, research, and mitigation to create a 900+ page bill. We have a runaway government, who’s interest is not the safety of the public, that is clear. (see more about the evolution of this bill from NVIC )
What does it really mean?
Vaccines will be fast -tracked and require LESS safety testing
HR 34 allows the approval of drugs by the FDA vaccines “with the least BURDENSOME means.” Drugs should require the MOST rigorous testing, not the least burdensome means.
Now your child’s vaccines are going to be developed with even LESS testing than before, and will all be fast-tracked to production. Government mandated vaccines and an exponentially growing vaccine schedule the vaccine manufacturers will make lots and lots of money.
Keep in Mind: The vaccine manufacturers having ZERO legal liability for their products, and 300 new vaccines in the development pipeline – the pharmaceutical industry literally cannot lose, no matter how many lives are destroyed.
“The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” said Barbara Loe Fisher, NVIC Co-founder and President. “Making experimental drugs quickly available for the sick and dying, who voluntarily choose to use them, is one thing, but Congress should not be greasing the skids to license experimental vaccines that government will recommend and legally require healthy children and adults to use. It is a prescription for disaster.”
Medical testing no longer requires informed consent.
Even more ominous is the section 2263 the elimination of informed consent. What is informed consent ? Permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits. Now all patients receiving treatment by any medical doctor may be, WITHOUT THEIR KNOWLEDGE, enrolled in a clinical trial for drugs and devices as long as there is “minimal risk” to the patient and the practitioner, and as long as there are “safeguards”. The effect of this act is to leave “safety” to guesswork and rationalization, and to allow the medical establishment to assess harm in drugs and devices in a manner in which
(1) the patients are not informed that they are in a clinical trial, and
(2) they have no right to say “No” to being part of an experiment.
If they are harmed during the trial, they cannot know that they should sue because any ill effect of the experimental drug or device cannot be traced to the experiment. This allows the medical establishment to experiment on the population with impunity.
The act does not specify “minimal risk”.
This provision makes no sense logically, or scientifically, and is dangerous. We use clinical trials not only to study the efficacy of drugs and devices, but also to determine their safety profiles.
Please watch the video of Senator Elizabeth Warren speaking out against this bill (in the first comment of this post), for more information.