18 assertions about vaccines: #12: Vaccine manufacturers and the CDC are only self-regulated

Point #12

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

12) the CDC and vaccine manufacturers conduct many of their own studies of their products and conduct their own investigations of themselves, which is like saying "I have investigated and studied myself, and come to the conclusion that I am not guilty of any wrong doing."

Again, nested claims:

1. The CDC conducts its own studies of its products
2. The CDC conducts its own investigations of itself
3. Something about the CDC wrongdoing
4. Vaccine manufacturers conduct many of their own studies of their products
5. Vaccine manufacturers conduct their own investigations of themselves
6. Something about vaccine manufacturers wrongdoing

I am confused by the claim that the CDC has "products". It isn't a business, and does not sell "product".   Perhaps the author has some misapprehensions about the Vaccines for Children program?

The Vaccines For Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. CDC buys vaccines at a discount and distributes them to grantees—i.e., state health departments and certain local and territorial public health agencies—which in turn distribute them at no charge to those private physicians’ offices and public health clinics registered as VFC providers.

Or maybe the author is misinformed about the fact that the CDC does patent some things. Skeptical Raptor goes into the patent issue in some detail. I encourage you to read the whole post closely

Yes, the CDC vaccine patents are a large portfolio of intellectual property on various aspects of vaccines, because the CDC does a boatload of research on infectious disease, which leads to vaccines. Eventually, they invent something, maybe finding the exact antigen on a virus that induces an immune response, and patent attorneys at the CDC file a patent on that “invention.” It protects the CDC from corporations or individuals who would rely upon CDC inventions, then patent it for themselves. So, the CDC (or any federal science agency, like the NIH, US Geological Survey, or whomever) has a portfolio of patents it can license to anyone who wants to pay for them.

Now the CDC does not license the patents themselves. The patents are licensed to outside entities by the National Institutes of Health Office of Technology Transfer (OTT), which is responsible for licensing all of the patents generated from the Department of Health and Human Services. So, even at this point, the CDC really isn’t responsible for selling the patents and receiving the royalties,

I'm calling the first point THE AUTHOR'S OPINION

On to "The CDC conducts its own investigations of itself". Here, it looks like the author is quite naive about how her federal government actually works. Both the Government Accountability Office (GAO) and the HHS Office of the Inspector General have oversight of the CDC. In addition, United States House Committee on Oversight and Government Reform has held hearings relative to the CDC. Looks like this is also THE AUTHOR'S OPINION.&nbsp

Based on the previous two points, I'm calling the "CDC wrongdoing" THE AUTHOR'S OPINION.

On to "Vaccine manufacturers conduct many of their own studies of their products". The author seems quite naive about the vaccine industry in general, and process of vaccine development and production in particular. Let's disambiguate.

The European Vaccine Initiative (which is leading European efforts to develop effective, accessible, and affordable vaccines against diseases of poverty) has an excellent primer on the processes of vaccine development:

Only a tiny percentage of candidate vaccines progress to licensing, making the costs of vaccine Research and Development extremely high..

Development of vaccines can be simplified into two broad stages:

1. Pre-clinical development is research carried out in lab assays and on animals. It includes:
1. Identification (discovery) of relevant antigens (e.g. screening)
2. Creation of the vaccine concept
3. Evaluation of vaccine efficacy in test tubes and animals
4. Manufacture of the vaccine to Good Manufacturing Practice standards
2. Clinical development is when the vaccine is first tested in humans. It covers four stages over several years, from initial clinical trials in humans (phase I) right through to introduction and beyond (phase IV). Clinical development is built on rigorous ethical principles of informed consent from volunteers, with an emphasis on vaccine safety as well as efficacy.
1. Phase I clinical trials are small-scale trials to assess whether the vaccine is safe in humans and what immune response it evokes. 
2. Phase II clinical trials are larger and look mainly to assess the efficacy of the vaccine against artificial infection and clinical disease. Vaccine safety, side-effects and the immune response are also studied.
3. Phase III Vaccines that progress to phase III clinical trials are studied on a large scale of many hundreds of subjects across several sites to evaluate efficacy under natural disease conditions. If the vaccine retains safety and efficacy over a defined period, the manufacturer is able to apply to the regulatory authorities for a licence to market the product for human use.
4. Phase IV The final phase happens after the vaccine has been licensed and introduced into use. Also called post-marketing surveillance, this stage aims to detect rare adverse effects as well as to assess long term efficacy.

So of course the vaccine manufacturers "conduct their own studies" in the pre-clinical phase, and in Phases I-III. The vaccines are not yet commercially available. How about Phase IV? This is where the author's naïveté (or US-centrism) really shows. The US uses the VAERS and Vaccine Safety Datalink for Phase IV safety and efficacy studies, but there is also the European Pharmacovigilance Commission, and WHO has its Programme for International Drug Monitoring, in addition to many countries maintaining their own pharmacovigilance systems. I'm calling this claim THE AUTHOR'S OPINION.&nbsp

How about "Vaccine manufacturers conduct their own investigations of themselves"? Again, naïvité. "In the US, As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency." Not to mention the plethoria of regulations and investigatory bodies internationally. I'm calling this point  THE AUTHOR'S OPINION

How about "vaccine manufacturers' wrongdoing"? Is she claiming that vaccine manufacturers are universally exempt from litigation? As a convenience sample, there's the Merck shingles vaccine lawsuit and the Merck whistleblower suit re mumps vaccine efficacy. I'm declaring this point THE AUTHOR'S OPINION.

VERDICT:  THE AUTHOR'S OPINION.&nbsp

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