By Leslie Carol Botha
August 5, 2011
In the interest of public health and safety, SaneVax Inc. formally requests the FDA release the lot numbers of vials contaminated with charred plastics, the number of doses produced in those lots, and the distribution routes. This information must be compared to the adverse reactions listed the VAERS reports.
August 5, 2011. According to Katherine Hobson of the Wall Street Journal: ‘The latest pharma world example of wow-that-really-shouldn’t-be-in-there comes from Merck & Co.’ Last week, reports circulated around the Internet primarily in business/stock market sections of newspapers of yet another FDA investigation exposing the discovery of charred bits of plastic shrink wrap in vials of vaccines made at a plant in West Point, Pa.
According to the Dow Jones Newswires the contaminated vaccines include Gardasil for the prevention of HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella.
Merck’s official position is the problem is rare and they aren’t aware of any adverse health events associated with the problem. The company remains confident in the safety and efficacy of its products.
Where is the logic – the science – the protection – the ‘do no harm?’ How can injecting vaccines with known contaminants into human beings be an acceptable practice?
Unfortunately, Pharma’s assurances they will clear extraneous materials from vaccines appear to be nothing more than empty promises. Many vaccines have been shown to contain unwanted viruses, bacteria, or even mycoplasmas. Anthrax vaccines had flecks of stopper material and fungi in them, noted on visual inspections by FDA in the late 1990s. It has become an accepted practice when drugs or other medical products are manufactured to tolerate unwanted contaminants falling into the mix — say, beetle parts in baby formula, or glass flakes in anemia drugs – that is until you get caught.
This time, it appears the shrink-wrap wasn’t removed from incoming glass vials prior to washing and was charred during the sterilization process, leaving burnt residue in the vials at Merck’s West Point plant.
The FDA has been tracking problems at the West Point plant since 2008. A series of inspection reports have chronicled the issues — most of which have been resolved, according to Merck. Twelve incidents of shrink wrap contamination have been reported since 2009. Merck has responded by moving away from the use of shrink wrap in favor of cardboard trays. Some vials are still shrink-wrapped, however, and the company says it hopes to phase these out by the end of the year, according to Dow Jones.
Merck says there are no reports of adverse health problems, though theoretically the particles could cause a reaction at the injection site. How would Merck know what kind of ‘charred plastic reaction’ that would cause? Have there been any studies conducted to determine whether injecting particles of charred plastic is safe?
Has anyone considered that the real culprit behind the adverse reactions may be the invisible toxic chemical emissions interacting with the vaccine?
According to Chem Tec Publishing: ‘Plastic when heated emits volatile organic compounds that contribute to the deterioration of ambient air quality in terms of odors and pollutants…. These contaminants are of particular concern in confined spaces such as car interiors, houses and offices.’ 1.
What about the confined space of a vaccine vial?
What happens to the structure/integrity of a vaccine when exposed to toxic gas? Where are the scientific studies?
In 2007, Indoor Air Journal published an article titled: ‘Indoor Residential Chemical Emissions as Risk Factors for Respiratory and Allergic Effects in Children: a Review,’ by Mark J. Mendell with the Lawrence Berkeley National Laboratory, Indoor Environment Department who cited that:
Most research into effects of residential exposures on respiratory health has focused on allergens, moisture/mold, endotoxin, or combustion products. A growing body of research from outside the U.S., however, has associated chemical emissions from common indoor materials with risk of asthma, allergies, and pulmonary infections. Risk factors identified most frequently included formaldehyde or particleboard, phthalates or plastic materials, and recent painting .2.
So what is shrink wrap made of?
Shrink and stretch wrapping can be quite complex in structure. Most packaging films used for shrink and stretch wrapping are from the polyolefin range. The materials are produced from oil based chemicals by what is called a polymerization process, which basically means getting the right molecules and atoms to club together in a way that is required or desirable for a particular application. The most common plastic materials are polyethylene, polypropylene and poly vinyl chloride. 3.
What happens when one of these plastics becomes charred? Polymer Plastics emit carbon dioxide and depending on the plastic, the combustion stage produces flames (which can propagate), charred surface layers and can be accompanied by the emission of smoke and toxic gases. 4.
In a 2006 Material Safety Data Sheet from Inhance/Fluoro-Seal, Ltd. states that Polyethylene is not classified as hazardous by OSHA standards although it does emit toxic fumes that ‘may include carbon monoxide and other organic vapors’ when burned. However the safety sheet states ‘No adverse health effects are anticipated from the reasonable use of this product.’
Eyes: This specific product has not been tested. Mechanical irritation and tissue irritation may occur.
Inhalation: This specific product has not been tested. Inhalation may cause soreness in the nose and throat, and coughing.
Skin: This specific product has not been tested. Mechanical irritation and tissue irritation may occur.
Ingestion: This specific product has not been tested. However, low toxicity by this route is expected based on the biological activity of similar materials.
Chronic Health Effects: This specific product has not been tested.
Medical Conditions Aggravated by Exposure: This specific product has not been tested. 5.
An environmentally-friendly product, polypropylene is made from carbon and hydrogen, manufactured without any dangerous emissions. When burnt or incinerated, polypropylene will only give off water vapor or carbon dioxide, which is converted by photosynthesis (chlorophyll). 6.
Poly vinyl chloride
PVC production involves the creation of many toxic chemicals. Dioxins, including TCDD (one of the most toxic synthetic chemicals known) and furans are inescapable by-products of the production of the basic feedstock of PVC, vinyl chloride monomer. PVC needs a host of additives to make it useable. Lead, cadmium or organotins are used as stabilizers. Phthalates are used as softeners in PVC and other chemicals used as colorants, fire-retardants and anti-oxidants. Many of these are released into the environment.
When PVC is incinerated it releases its chlorine content and again causes the release of dioxins which are formed when chlorinated organic compounds, or a mixture of inorganic chloride and organic matter are burned.
Toxic chemicals released during the production, use and disposal of PVC threaten the environment and human health. Dioxins – known carcinogens and hormone disrupters, persist for many years and accumulate in the fatty tissues of living organisms.
Politicians assure us that certain levels are not harmful. Scientists are divided. Arguments about safe levels and tolerable daily intakes miss the point. Mothers should not be forced to feed any level of carcinogenic, or potentially hormone disrupting chemicals to their children. 7.
Nor should parents be expected to expose their children to contaminated vaccines. When adverse reactions from Gardasil include increased rates of cancer, hormone disruption, infant death post- breast feeding one has to begin to wonder what part of this vaccine is safe and efficacious – not only in terms of listed ingredients but also those that “fall into the mix” during the manufacturing process.
The SaneVax Team is demanding the FDA hold Merck accountable for this new chemical contamination atrocity. Vaccine safety and efficacy cannot be proven until contamination is eliminated. In the interest of public health and safety, release all of the information on the vaccines contaminated with charred plastic. Prove you mean what you say about ‘transparency’ in government. Medical professionals and consumers alike have a right to know.
1. Emissions from Plastics – ChemTec Publishing
2. Indoor Residential Chemical Emissions as Risk Factors for Respiratory and Allergic Effects in Children: a Review, Indoor Air Journal, vol. 17, pp. 259-277, 2007 http://eande.lbl.gov/ied/sfrb/pdfs/voc-1.pdf
3. Shrink Wrapping and Stretch Wrapping- ENVIS-ICPE India
4. Flammability of Polymers – Zeus Technical White Papers
5. Material Safety Data Sheet – Inhance/Fluoro-Seal, Ltd.
6. Polypropylene An Environmentally Responsible Product – Ambro Plastics
7. What’s Wrong with PVC? Green Peace