#informedconsent

The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

Second, the FDA pointed out that both the licensed Pfizer Comirnaty vaccine, and the existing vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

There is a huge real-world difference between products under an EUA compared with those that FDA has fully licensed. EUA products are experimental under U.S. law.

Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

EUA-licensed vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products.

The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from an generous retinue of liability protections.

But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.

And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.

The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.

While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.

And FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority of vaccines available in the U.S., if not all, remain unlicensed EUA products.

Here’s what you need to know when somebody orders to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.

If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.

The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.

Written by Childrens Health Defense with Robert F. Kennedy, Jr.

Robert F. Kennedy, Jr.’s reputation as a resolute defender of the environment stems from a litany of successful legal actions.

Meryl Nass, M.D.

Meryl Nass, MD, ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology.

Informed Consent is a curious term in the medical world.  Federal law states that in order to obtain informed consent, a doctor must talk to the patient regarding all the risks, benefits, and alternatives for the treatment or procedure.  It is not just a signature on a piece of paper.   That works in theory in a medical setting.  However, when informed consent is applied in practice, it invariably falls apart.

 That’s because many nurses and doctor haven’t been consistently taught the law regarding patient rights when it comes to getting full consent from a patient.  And likewise, patients don’t know their rights most of the time either.  In most states, only doctors can obtain informed consent for surgical or diagnostic procedures.  In fact, the California Hospital Association’s Consent Manual specifically states that “It is the physician’s responsibility to obtain informed consent…Hospital personnel should not be involved in providing information necessary to give informed consent or responding to questions regarding the procedure.” 

 The issue of informed consent is the basis of all patient care in this country.  It is one of the issues closest to my heart, one that led me to become a patient safety advocate.

 I learned about all the ramifications of informed consent the hard way when I  investigated my father’s death.  In his nursing home records, I discovered that he had been given Haldol and Risperdal, two black box antipsychotic drugs that require informed consent because of the risks of severe side effects and even death. I also discovered a number of falsified consent forms, which stated that that various nurses had obtained consent for these dangerous drugs “over the phone” from me, even though I was at the facility every day.  Then in the hospital records, I was shocked to find the doctor had falsified a “Do Not Resuscitate” order, also claiming it had been obtain “by phone.”

 Later, in forced arbitration, the defense claimed that these consents were necessary for treatment.  The lack of my signature as power of attorney on these consent forms, along with phone records as proof the calls were not made, did not impressed the judge one iota, and we lost the case.  The Medical Board of California was only slightly concerned by the lack of documentation. It allowed the doctor to plea down to “poor medical record keeping” for the DNR, and was given a public letter of reprimand.

 This has taught me to be extra vigilant when signing any medical documents.  For example, a few years ago when having to undergo eye surgery for a hole in my retina, I read that the consent form included a clause that a “trainee” could do the surgery under the supervision of the surgeon.  I crossed out that clause and immediately spoke to the doctor, saying I would only consent if I knew for sure he would be the only surgeon.  However, despite being keenly cautious with consent forms, you never know when you will be blindsided.

 My latest “consent” experience occurred during an unexpected emergency with my husband.  Ed was in the hospital for a routine procedure when it was discovered he was severely anemic and bleeding internally.  His procedure was halted and we were sent to a room to await an emergency endoscopy to find the source of the bleeding.  Twelve hours later, with both of us stressed and exhausted, Ed was finally taken down to the endoscopy department.

 Nurse Bonnie approached Ed with a clipboard and pen and told him to sign the consent form.  I stopped her, saying we had not spoken to the doctor so he could not give informed consent for the endoscopy yet.  I had questions about the risks, especially about whether this hospital used an Olympus scope, the kind linked to a deadly superbug infection called CRE.  Bonnie seemed annoyed. The conversation went something like this:

 Bonnie:  He needs to sign the consent form.

 Me:  I want to talk to the doctor first about the risks before he gives informed consent.

 Bonnie: I can give informed consent.

 Me: Nurses can’t obtain informed consent.

 Bonnie: I do it all the time.

 Me: Well, legally, and according to state law, you can’t.

 It was obvious that this nurse did not understand the informed consent process.  She equated it with just a signature on a paper.  Just as I was about to dig in my heels with this nurse, the doctor arrived and was more than willing to answer all my questions.  Ed quickly signed the consent form, and was whisked down the hall to the procedure room.

 A few days later, once Ed had been diagnosed and treated, I realized that Ed was not given the time to read that endoscopy consent form before signing it.  It also bothered me that Nurse Bonnie had said she obtained informed consent all the time. I explained this to the Patient Relations person at the hospital, suggesting perhaps the nurse was confused about informed consent. A few days later, I received a written response that stated:

 “It is our understanding that the form you and your husband were asked to sign is the ‘Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures’ form which is not informed consent.”

 ???

 I had two thoughts about this sentence. First, this facility thinks the consent form is not a consent?  If this was not a consent, why did Nurse Bonnie insist on Ed signing it? I felt like telling the Patient Relations person that I know some lawyers that would think otherwise.  Secondly, it appears that this person was getting stuck on semantics.  Yes, the doctor is the authorized person to obtain informed consent.  However, the process is not considered complete until the consent form is signed as proof that the patient was fully informed.

 I contacted the director of the endoscopy department and politely asked for a copy of a blank consent form since it would take two weeks to get a copy of Ed’s records. She sent me a copy of the second page of the endoscopy consent form.  Thinking that maybe she had forgotten to send the first page, I contacted her again.  She was surprised; she told me she had never seen a first page, but would see if she could find one.

 So this hospital had been having people sign a consent form that was incomplete? One that was missing the first page of instructions?

 The Patient Relations person was also surprised when I called her back.  She suggested that the consent could be double sided, and that perhaps we just didn’t see the other side. She said she will get back to me regarding the first page of the consent form, and assured me that they are already “reviewing the process for completing the appropriate paperwork prior to procedures for all endoscopy patients.” 

 Good. That’s all I wanted – a full informed consent process for all patients.

 What I have learned from these experiences is that hospitals and nursing homes still have a long way to go in ensuring informed consent protocols are followed. All too often, transparency and patient safety are comprised in order to get a form signed faster. In my opinion, every facility should have an informed consent review every year for every employee, including doctors. 

Ethical issues in clinical trials matter — because patient rights and safety come first.

Informed consent, fair subject selection, privacy protections, and strong safety oversight ensure research is trustworthy and inclusive. When these standards are upheld, clinical trials become safer, more equitable, and more effective for everyone.

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