18 assertions about vaccines: #9: Is There Something Nefarious About Vaccine Package Inserts vs Vaccine Information Statements?

Point #9

The following are NOT opinions, but actual verifiable facts. Research any of it if you have doubts or just want to expand your knowledge.

9) full vaccine package inserts are 10's of pages long, not just the 1-2 page you are given at the doctors office.

I am not sure what point the author is trying to make here. Let's take a look.

There are two legally-required documents relative to any pharmaceutical product given to consumers.  With respect to vaccines, the first is called the "Vaccine Information Statement" (VIS), and is mandated by TITLE 42—THE PUBLIC HEALTH AND WELFARE, § 300aa–26. Vaccine information (c). If you want to see all vaccine VISs, downloads are available here. You can also read a bout the history of Vaccine Information Statements, if you want. The second is generally known as a "package insert" (Patient Information Leaflet in EU countries and Instructions for Use in other areas)

With respect to the VIS, this is what the law requires:

Information requirements

The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include—

1. a concise description of the benefits of the vaccine,
2. a concise description of the risks associated with the vaccine,
3. a statement of the availability of the National Vaccine Injury Compensation Program, and
4. such other relevant information as may be determined by the Secretary.

With respect to the longer document, the "Package insert" -- it has evolved over time. Here is one explanation for pharmacists:

The 1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions on foods, drugs, cosmetics, and medical devices. Thus, the importance of educating consumers about products they use is well recognized. Although a manufacturer of any product generally carries the responsibility to warn the user about the risks associated with the product’s use, manufacturers of prescription drugs are not required to warn each patient who uses their products. Instead, when it comes to prescription drugs, the manufacturer’s duty is to provide prescribing physicians with information about the proper use and risks of the product so that the prescriber is then better equipped to educate the consumer/patient about the drug’s use and risks; this is referred to as the learned intermediary doctrine. The rationale behind this doctrine is that the complexity of the information involving prescription drugs necessitates an intermediary who can explain or interpret the benefits and risks associated with the use of the drug to the ultimate user—the patient.

The blogger known as Skeptical Raptor is a retired pharmaceutical executive, thus a great deal of expertise in this area:

What is a Package Insert?

All of you have probably seen a package insert [PI]–it’s a multiple page document that is included with all real medications .... Depending on the type of drug, the PI can be 30-40 pages long, although most are printed on one huge sheet of very thin paper so that it can be folded tightly and placed in each box that over-packages the drug’s container (vial, bottle, etc).

Although some people believe it’s written in small fonts on thin paper to make it difficult to read and use, it’s actually done so to save on shipping costs. Yes, if you had to fold up a large font-sized package insert and place it in each box that contains a vial or bottle of medication, the shipping weight and volume would make the cost astronomical. And that cost would pass down to consumers.

In general, package inserts are part of what is called the “labeling” of the drug, which means all the verbiage that pharmaceutical company may say about the drug. It is not just the printing on the vial or box, labeling encompasses almost everything said about the drug, including advertising, PI’s, and yes, the box and printing on the vial.

You will hear FDA regulators and individuals in pharmaceutical companies refer to “labeling” all of the time. Labeling is strictly regulated because it establishes the claims made about the drug or device, how it is to be used, and other pertinent information. Even what sales reps say to physicians in a sales call is covered by the drug’s labeling.

In the USA, the Food and Drug Administration has established very strict rules in the Code of Federal Regulations (CFR) on what can be and cannot be stated in the package insert. There is very little variance in format or quality of information from one PI to another one even for very different classes of drugs. Amusingly, the regulations even state the type and size of the font used in the PI.

Generally, vaccines are distributed in bundles of 5 or 10 single-use syringes, or multi-dose vials, unlike other products. However, the PI for pediatric vaccines are readily available, for example from Immunize.org, or The Institute for Vaccine Safety or even from The FDA

The original claim is that essentially, the Vaccine Information Statements are shorter than the Vaccine Package Inserts. That's true. The implications, though, are rather silly.

AN OBJECTIVE FACT (you know, supported by evidence, which the author has provided)

Here is the list of claims, with links to the discussion of each claim:

• Bonus: Claim that "I'm doing the research that your pediatrician NEVER had to do."
• #1 Combined doses of Vaccines have NEVER been tested for safety. 
• #2 Vaccine manufacturers have been granted legal immunity from being sued when their products inflict damage. 
• #3 DNA from aborted fetuses is in vaccines.  
• #4 the CDC has been caught destroying and hiding evidence  
• #5 outbreaks occur in populations that are up to 90-99% vaccinated -- herd immunity a myth 
• #6 More people die from the MMR vaccine itself than die of the measles. 
• #7 Peanut allergies were almost unheard of prior to the use of peanut oil in vaccines. 
• #8 Multiple independent studies have shown vaccinated children are more likely to have asthma. 
• #9 Information on vaccines is hidden from parents.
• #10 Vaccine package inserts prove the dangers of vaccines.
• #11 Doctors are bribed to vaccinate
• #12 Vaccine manufacturers and the CDC are only self-regulated
• #13 Doctors are ill-informed about vaccines 
• #14 Vaccines cause SIDS&
• #15 Diseases have been renamed after the introduction of a vaccine. 
• #16 The anti-vaccine movement isn't new  
• #17 All live virus vaccines shed and cause diseases  
• #18 Combining acetaminophen and vaccines is dangerous. 
• Bonus: MTHFR gene variants and vaccination