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The recent public conversation about the safety of vaccine ingredients has centered primarily around mercury (thimerosal), aluminum and formaldehyde. However, there are other concerning ingredients in vaccines that are not talked about as often, one of which is Polysorbate 80—also known as Tween 80 and polyoxyethylene-sorbitan-20 mono-oleate.¹ 

What is Polysorbate 80?

Polysorbate 80 is a surfactant commonly used in the pharmaceutical, cosmetic and food industry.¹ Surfactants are compounds that reduce the surface tension and increase the solubility between two liquids that would normally be unable to dissolve together, e.g. oil in water.^2 3  Because of their ability to lower surface tension between liquids, surfactants are known for their spreading and wetting properties. Therefore, surfactants act as detergents, emulsifiers, wetting agents, foaming agents and dispersants.^{1 2}

To prevent separation of liquids, Polysorbate 80 is present in several formulas such as skin care products, shampoos, makeup, ice-cream, processed salad dressings and sauces.^{3 4} Within the pharmaceutical industry, polysorbate 80 is used to improve and maintain consistency of gel capsules; assist in keeping medication suspended in liquids; in preparation of intravenous fluids; as an excipient in tablets, and in the manufacture of vaccines.^{1 4}

Polysorbate 80 in Vaccines: Not Well Tested

The U.S. Centers for Disease Control and Prevention (CDC) Vaccine Excipient and Media Summary lists 11 vaccines that contain polysorbate 80:

• DTaP (Infanrix);
• DTaP—IPV (Kinrix);
• DTap-HepB-IPV (Pediarix);
• DTaP-IPV-Hib (Pentacel);
• Gardasil
• Influenza (Agriflu);
• Influenza (Fluarix);
• Meningococcal (MenB-Trumenba);
• Pneumococcal (PCV13—Prevnar13);
• Rotavirus (RotaTeq);
• Tdap (Boostrix)⁵

According to the Material Safety and Data Sheet (MSDS) on ScienceLab.com, Polysorbate 80 was tested for inhalation and ingestion and demonstrated to be slightly hazardous in case of skin contact.⁶ The MSDS does not address the effects of polysorbate through injection. Nevertheless, in the same toxicology section under special remarks on chronic and toxic effects on human, it states that Polysorbate 80:

 May cause adverse reproductive effects based on animal test data. No human data found. May cause cancer based on animal test data. No human data found. May affect genetic material (mutagenic). Ingestion of very large doses may cause abdominal spasms and diarrhea. Animal studies have shown it to cause cardiac changes, changes in behavior (altered sleep time) and weight loss (upon repeated or prolonged ingestion). However, no similar human data has been reported.⁶

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Dr Stephanie Seneff, Statistician from MIT:

THE PLOT THICKENS:

April 26, 2016

Brian S. Hooker, Ph.D., P.E. | Science Adviser, Focus For Health

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Dr. William Thompson, senior scientist at the Centers for Disease Control and Prevention (CDC) contacted me during 2013 and 2014 and shared many issues regarding fraud and malfeasance in the CDC, specifically regarding the link between neurodevelopmental disorders and childhood vaccines. Dr. Thompson and I spoke on the phone more than 40 times over a 10 month period and he shared thousands of pages of CDC documents with me. Eventually, Dr. Thompson turned this information over to Congress via Rep. Bill Posey of Florida. Among the issues discussed in the phone conversations were lies told to the public by the CDC regarding the link between thimerosal-containing vaccines and neurodevelopmental disorders (including autism) as well as the links between the MMR vaccine and autism in African American males and the MMR vaccine and “isolated” autism. Isolated autism is the term coined by CDC researchers referring to all children who received an autism diagnosis without additional diagnoses of mental retardation, cerebral palsy, visual impairment or hearing impairment.

Very recently, Mr. Richard Morgan, Esq., Dr. Thompson’s whistle blower attorney, stated that Dr. Thompson will be publishing a paper in May, 2016, where he will assert that the MMR vaccine is not linked to autism in African American males. Instead Dr. Thompson will state that socioeconomic factors alone in the African American community account for the original MMR-African American male “effect” (the effect that he is on record as stating the CDC purposefully hid). I have not been given access to Dr. Thompson’s reanalysis and therefore cannot comment regarding the forthcoming paper at this time. However, I am suspect of any analysis coming from the CDC due to the historic nature of the agency’s scientific misconduct and conflicts of interest specifically around any link between vaccines and autism.

Regardless of the content of Dr. Thompson’s reanalysis paper, these facts remain:

• 1. CDC scientists colluded to cover up a relationship between the timing of the MMR vaccine and autism in African Americans that was first discovered in November of 2001. Rather than reporting the results to the public, all data regarding this relationship were destroyed at a secret meeting held some time in August/September of 2002. This fact has been affirmed via an affidavit given by Dr. Thompson to Rep. Bill Posey in September, 2014.
• 2. Dr. Thompson attempted to warn the CDC Director at the time, Dr. Julie Gerberding, regarding this relationship, prior to the February 2004 Institute of Medicine meeting on vaccines and autism. Rather than allowing Dr. Thompson to present the information at this meeting, Dr. Gerberding replaced him as a speaker with Dr. Frank Destefano, current director of the CDC’s Immunization Safety Office, where he presented fraudulent results regarding the MMR vaccine and autism. Dr. Thompson was put on administrative leave and was threatened that he would be fired due to “insubordination.”
• 3. When Dr. Thompson attempted to leave the CDC later that same year, he was given a $24,000 retention bonus. Dr. Thompson’s impression of the timing of this bonus, in light of disciplinary actions taken against him earlier that year, is that CDC officials were “buying his silence” through controlling his actions as a CDC employee.
• 4. Dr. Thompson has published two papers linking thimerosal exposure in infant vaccines to tics in boys (Thompson et al. 2007 and Barile et al. 2012). CDC fraudulently maintains on their website that “There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.” (http://www.cdc.gov/vaccinesafety/concerns/thimerosal/). The tic result was also affirmed in the earlier CDC publication by Verstraeten et al. (2003) and the Andrews et al. (2004) publication.
• 5. CDC pressured Dr. Thompson to downplay the tic result of his analysis in his 2007 paper. He was instructed to deemphasize the tic result by the CDC’s Chief Science Officer, Dr. Tanja Popovic, by emphasizing that the “major finding of the study” was “there is NO associations (sic) of thimerosal exposure with the great majority of the outcomes.” Dr. Popovic also instructed Dr. Thompson to interpret any negative outcomes as “chance findings.”
• 6. CDC also pressured Dr. Thompson to withhold publication of his 2012 paper which reported a relationship between thimerosal and tics. Dr. Ed Travathan, head of the CDC’s National Center for Birth Defects and Developmental Disabilities, stated in an April 27, 2009 memo to him that the analysis was sound except for the tic results and that they should be omitted from the publication. Since the tic result was the only result that had a consistent negative relationship with thimerosal exposure, it seemed that Dr. Thompson’s superiors were specifically concerned that thimerosal’s safety and use not be questioned. As an epidemiologist, Dr. Thompson was justifiably concerned and critical of the CDC’s action to approve the paper for publication only after the CDC took the extraordinary step of adding an expert in tics to water down the paper to state, “This finding should be interpreted with caution due to limitations in the measurement of tics and the limited biological plausibility regarding a causal relationship.”

Thompson himself instructed me regarding the link between thimerosal and “autism like features” and stated that “tics were like five times more common in children with autism.” Yet the CDC will not recommend thimerosal-free vaccines and thimerosal is still used in many flu shots given to infants and pregnant women in the U.S.

Beyond this, the CDC, through the fraud and scientific malfeasance revealed by Dr. Thompson and others, has been shown repeatedly to be a conflicted, dysfunctional agency having no business stewarding vaccine safety for the United States. I join the call from Dr. William Thompson and many others to remove vaccine safety surveillance activities from the CDC to an entity completely independent of the CDC and Department of Health and Human Services as a whole. Again, the revelations of Dr. Thompson go far beyond issues with the MMR vaccine and affirm my own inquiry of the CDC starting in 2001. Please join me in calling for an immediate Congressional investigation of this agency.

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Silent Crow News

New Report says “Vaccine Market” Worth $61 Billion by 2020

Timothy Alexander Guzman, Silent Crow News – The business of vaccines is soon to become a major source of profits for the world’s largest pharmaceutical corporations. A press release (Business Wire, January 21st 2016) published by marketwatch.com says that Technavio, one of the leading technology research and advisory companies in the world predicts that pharmaceutical corporations who produce vaccines will reach an estimated $61 billion in profits by 2020. Today the vaccine market is worth close to $24 billion. The report titled ‘Global Human Vaccines Market 2016-2020’ gives an “in-depth analysis” of the possible revenues and “emerging market trends” globally. According to the Press Release:

The report study indicates that the introduction of new products is fueling the growth of the market. Moreover, the significant expansion of the current product offerings is also expected to boost the market growth. Due to the increasing prevalence rates of various infectious diseases such as diphtheria, influenza, hepatitis, pneumococcal diseases, and meningococcal diseases, there has been a notable increase in the use of vaccines across the globe

What is interesting about the report is that Pharmaceutical corporations are targeting Latin America and the Caribbean with its new vaccines soon to be on the market. Merck & Co, Pfizer and GlaxoSmithKline (GSK) are expected to dominate Latin America and the Caribbean (Puerto Rico currently operates as a manufacturing hub for Merck, Pfizer and Abbott Laboratories):

In terms of geography, the Americas dominated the global human vaccines market in 2015, accounting for about 45% of the total revenue. The US was the largest revenue contributor to this region in the same year, capturing a significant portion of the global market. The Americas will continue to dominate the human vaccines market during the forecast period because of the increase in the prevalence of infectious diseases and cancers. In addition, increase in strategic alliances with expected entry of novel vaccines, is also expected to propel the growth of the market in this region

The report also says that there are two types of human vaccines, Therapeutic (cancer, metabolic disorders, chronic illnesses, and infectious diseases) and Preventable human vaccines markets (pediatric vaccinations) that are estimated to reach $55 billion worldwide. The Atlantic magazine published an article in 2015 titled ‘Vaccines Are Profitable, So What?’ Author Bourree Lam says:

While the main fixation of anti-vaccine groups is an old, discredited study linking vaccination to autism, another is a conspiracy theory circulated online that both doctors and pharmaceutical companies stand to profit financially from vaccination—which supposedly leads to perverse incentives in advocating for the public to vaccinate.

But that argument is historically unfounded. Not only do pediatricians and doctors often lose money on vaccine administration, it wasn’t too long ago that the vaccine industry was struggling with slim profit margins and shortages. The Economist wrote that “for decades vaccines were a neglected corner of the drugs business, with old technology, little investment and abysmal profit margins. Many firms sold their vaccine divisions to concentrate on more profitable drugs”

Maybe it was true at some point in time that manufacturing vaccines were unprofitable, but in today’s world, it’s all profits. What motivated pharmaceutical corporations to focus on the vaccine market in the last decade or so according to The Atlantic?

Since 2000, the Gavi Alliance has provided vaccination for 500 million children in poor countries, preventing an estimated 7 million deaths. GlaxoSmithKline reported that 80 percent of the vaccine doses they manufactured in 2013 went to developing countries. Additionally, vaccines that could turn a profit in high-income countries—constituting 82 percent of global vaccine sales in terms of value, according to the World Health Organization—hit the market

Lam also wrote that there were “two “blockbuster” vaccines also hit the market: pneumococcal conjugate for meningitis and other bacteria infections, and a vaccine for human papillomavirus (HPV). The industry grew”.

Merck is the only pharmaceutical giant licensed to produce and sell the measles vaccine called Prodquad and the MMR II (also used for the measles, mumps and rubella) and Varivax, a vaccine for the chicken pox. According to Lam, all three vaccines combined amounted to more than $1.4 billion in sales profits for Merck in 2014. The controversial HPV vaccine, Gardasil also brought in $1.7 billion in profits for Merck. “While a spokesperson for Merck told The Atlantic that vaccines remained one of its key areas of focus—it generated $5.3 billion in sales in 2014—she did not comment on the profit margins” Lam wrote. Of course the Merck spokesperson would not comment on the profitability of vaccines because Merck would expose itself to more controversy. Analysts say that the profit margin is “between 10 to over 40 percent.” Lam also says that “while the vaccine industry is likely more profitable now than in the 1970s or 1980s, this is the result of global market forces”. Lam forgot to mention that billionaire couple Bill and Melina Gates pledged at least $10 billion for worldwide vaccination programs supposedly to combat polio and the measles, this is where Merck & Co profit. It is also well known that Bill Gates appointed the former president and CEO of Merck, Raymond Gilmartin to the board of directors of Microsoft which lasted for more than 11 years before he announced his retirement in 2012.

Are pharmaceutical corporations motivated by profits? “Profits from vaccine production aren’t a valid argument against vaccinations—the most important question is whether vaccines are safe and effective, and the answer is unambiguously yes” wrote Lam. In 2015, Former Merck Employee and whistleblower Brandy Vaughan Spoke out against the state of California’s vaccination mandate bill SB277 and said:

The U.S. gives more vaccines than any other country in the world. Our childhood schedule for under the age of one has twice as many vaccines as other developed countries. What else do we have? The highest infant mortality rate of any developed nation. Finland has the lowest. They only give 11 by age six. Mississippi has the highest rate of vaccination in the U.S.–highest infant mortality rate. These numbers do not lie. But you will not hear that on the media, and that is not what Senator Pan will tell you.

What we have with vaccines is the highest profit margin pharmaceutical drug on the market. Drug companies make more money off vaccines than they do any other pharmaceutical drug, in terms of profit margin. There is a lack of rigorous safety studies. And they don’t have the incentive to do them because they have no liability.

Vaccines are the only products in the U.S. that do not have liability. You cannot sue for injuries or death. But that is only in the U.S. Around the world, there are law suits because of serious injuries and deaths because from vaccines. In Spain over Gardasil. In Japan over Gardasil. The flu shot was taken off the market for under five in Australia after deaths and injury. Prevnar was banned in China. Pfizer’s vaccination program was kicked out of the country. France just pulled Rotavirus off their schedule after infant deaths and injuries

With a forecast of $61 billion in projected sales, rest assured new vaccines will be developed for almost anything. Actor and comedian Jim Carrey did say that “150 people die every year from being hit by falling coconuts. Not to worry, drug makers are developing a vaccine”. With 271 vaccines in production, Jim Carrey’s comments, which were criticized by the mainstream media, may not be so farfetched after all.

Posted in Media Analysis, Science & Medicine on 26 January 2016
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