Dr. Troy Ross

Safe and Effective?

It’s a marketing statement – safe and effective. Stop and think about it. What does that really mean? Is it a statement of absolute truth? Is it even marginally true? When medical professionals toss that statement out to their patients without context and objective information they’re violating patient trust and the obligation to provide informed consent. They are also exposing people to harm without offering a choice in whether to participate.

I’m writing this to my fellow medical professionals, asking you to take a few moments to peel away the layers of rhetoric, emotion, and paternalism. Let’s take an objective look at the issue of vaccinations. Regardless of the argumentative topics of herd immunity or the morbidity of disease, it is well accepted that we have an obligation to provide our patients with informed consent before we expose them to potential harm. It’s a term that is thrown around a lot. It rolls off the tongue easily enough – but do we put any meaning behind it?

The obligation to provide informed consent:

The preeminent medical society in our country, the AMA, lays this issue out clearly: Informed consent is a basic policy in both ethics and law that physicians must honor. So what does that look like? Well, the medical professional needs to “present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice”, and the patient should make his or her own determination about treatment. Now consider this: Federal Law requires vaccine providers to give specific vaccine information statements to patients for each vaccine administered prior to each dose. Of course, handing a parent a two page document with a bunch of complex terminology right before giving a shot is not an effective way to communicate important information – the right thing to do is to sit down with that person in a one-on-one setting and actually discuss the information.

So how good are we at giving patients the facts and discussing the risks versus benefits of vaccination? As a Public Health specialist, who has developed and run major vaccination programs for the Army I conclude – we are not doing very well, and we are not doing right by our patients.

 How safe are vaccines?

Vaccination against communicable disease is a priority for the Federal government. U.S. Code 42 § 300aa–1 states, “The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization”. OK, seems like a reasonable statement – I don’t have a problem with that. But now look at the very next part of that opening statement, “and to achieve optimal prevention against adverse reactions to vaccines”. Pay close attention here. That federal law does not say that vaccines will be made to have no adverse reactions. Optimal prevention: an interesting and slippery term. By whose definition? Since this is public health law the priorities and goals are formed around groups, not individuals. Optimal outcomes for the group may well cause harm to individuals. Federal law has absolved vaccine manufacturers of all liability, because the vaccine manufacturers and lawmakers knew that individuals were being done unavoidable harm. “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable”.

Part of formalizing the national vaccination strategy was a law passed in 1986. That law removed liability from both manufacturers and those who administer vaccines to patients. The law states, “There is established the National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine-related injury or death.” Since 1988, over 15,000 claims for injury and death have been filed and 3981 were compensated.  Over $3 billion paid out in settlements.

So how safe are the vaccines that we administer? Health and Human Services is proud to tell us that in the time period for the statistics above 2,236,678,735 vaccines were administered. So less than 4000 proven cases of injury or death, that’s not too bad, huh? Well it’s only statistics until it happens to you. Do you tell your patients that they have a statute of limitations of 3 years to report injury and 2 years to report a death related to vaccination? Did you even know that? Likely not. If a vaccine injured person misses those filing deadlines with the Federal Vaccine Injury Court he has no recourse.

Then there is the HHS list of injuries (including death) that are legally presumed to be caused by vaccines. Oh, and how about the list of toxic ingredients in the vaccines? The most concerning to me are the DNA and diploid cells from human fetuses – no harm in introducing that kind of stuff into the blood stream right? (yeah I know that cannibals get kuru but they eat lots of human flesh – a few micrograms jabbed into a baby should be fine).

Then there’s the package insert that comes with each vaccine. How many have read it? Here’s the key part: “The health-care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination”. So what are some of those things to inform our patients about? Here are some excerpts from the MMRpackage insert:

M-M-R II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.

mumps vaccine virus has been shown to infect the placenta and fetus,

There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse fetal effects.

Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established.

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