The Vaccine Autism Cover-up: How One Doctor’s Career was Des

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IN FRAUDULENTLY REPRESENTING AND OTHERWISE CONCEALING THE DIMINISHED EFFICACY OF ITS MUMPS VACCINE, MERCK HAS VIOLATED ITS MULTIPLE DUTIES UNDER THE U.S. VACCINE REGULATORY REGIME

102. There are three principal components to the government regulation and purchase of vaccines in this country. The CDC is responsible for the government's purchase of vaccines and for educating the public on, among other things, the safety and efficacy of vaccines and the importance of immunization. The FDA is responsible for overseeing the licensing and approval of vaccines, their manufacture and distribution, and how they are represented to health care professionals and the public through vaccine labeling. The National Vaccine Program, of the Department of Health and Human Services, is responsible for generally overseeing the U.S. vaccine program, including coordinating with the various agencies involved in the program and manufacturers like Merck, and ensuring that vaccines are safe and effective and in sufficient supply.

103. A critical underpinning of this overlapping vaccine regulatory framework is that each agency involved has accurate and up-to-date information on the safety and efficacy of the various vaccines licensed for use in this country. This information is particularly important for the CDC which purchases the vaccines pursuant to a contract with Merck. Not only does it decide which vaccines the government will purchase. It also creates the schedule of recommended vaccinations that determines those vaccines that children in public school are required to take. Furthermore, as codified in the National Childhood Vaccine Injury Act, the CDC has the duty to warn the public about the safety and efficacy of the vaccines. Notably, this is a duty that Merck was instrumental in establishing.

104. Merck thus has ongoing and independent duties to disclose to these agencies all material information relating to the safety and efficacy of its mumps vaccine. However, in misrepresenting a falsely inflated efficacy rate for its mumps vaccine and concealing what Merck knew about the significantly diminished efficacy of the vaccine, Merck has breached these multiple duties.

A. Merck's Duties to the CDC

1. Merck's Duty to Disclose Diminished Efficacy.

105. Merck has both a contractual and statutory duty to provide the CDC with accurate information regarding the safety and efficacy of its mumps vaccine. This duty is triggered by Merck's contractual and statutory delegation to the CDC of Merck's duty to warn the public about the vaccine's safety and efficacy. Without this delegation, Merck would be responsible -- as any drug manufacturer would -- for providing adequate information to consumers relating to the risks and benefits of the vaccine.

106. Merck and the CDC first agreed to this delegation back in the 1970's, at Merck's suggestion. It provided a way to assure that the CDC could purchase Merck's vaccines without Merck being subjected to personal injury claims for failing to warn individual vaccinees or their parents about the safety and efficacy of vaccines administered through government vaccination programs. As a result of the parties' negotiation, the CDC assumed the duty to warn with respect to all Merck vaccines it purchases. In exchange Merck agreed to provided the CDC with all of the information the CDC needs to adequately carry out the duty to warn.

107. This means that Merck has an ongoing duty to provide the CDC with accurate information on the efficacy of its mumps vaccine, including apprising the CDC of any problems Merck discovers, or in the exercise of reasonable care should have discovered, associated with the vaccine's stated efficacy. In the absence of any direct communications by Merck to the CDC relating to the vaccine's efficacy, the CDC principally relies on Merck's vaccine package insert for this information.

108. Merck benefits greatly from this arrangement as it protects Merck from liability for personal injury claims based on any failure to provide consumers with adequate warnings about the vaccine. All of the Merck-CDC purchase contracts (dating back from the late 1970s) contain language, originally drafted by Merck's counsel, providing that the CDC agrees to "take all appropriate steps to provide meaningful warnings [to consumers] relating to the risks and benefits of vaccination."

109. This delegation is now codified under the National Childhood Vaccine Injury Act which, among other things, requires the CDC to develop and disseminate vaccine information materials which provide: "(1) a concise description of the benefits of the vaccine ... and (4) such other relevant information as may be determined by the Secretary [of Health and Human Services]." 42 USC § 300aa-26(c). Merck-CDC purchase contracts still contain the delegation of the duty to warn, but now also cite to this provision as the relevant authority. The CDC also cites to this provision in the Vaccine Information Statements it publishes apprising vaccinees and their parents or guardians of the purpose, risks and benefits of a particular vaccine.

110. The Act further provides a notable (and logical) exception to the statutory release from liability of a vaccine manufacturer for a failure to warn. It does not apply of the manufacturer engages in "intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval." Indeed, under such circumstances, the manufacturer can be held liable for punitive damages for any failure to warn. 42 USC § 300aa-23(d)(2)(A) and (B).

111. As the Third Circuit has held, Merck's duty to provide accurate and up-to-date safety and efficacy information to the CDC is unequivocal and ongoing: "The manufacturer's responsibility is continuous, and it must therefore apprise the CDC of any risks it later discovers, or in the exercise of reasonable care, should have discovered." See Mazur v. Merck, 964 F2d 1348, 1365-66 (3rd Cir. 1992).

2. Merck's Additional Contractual Duties to the CDC

112. The Merck-CDC purchase contracts also obligate Merck to comply with various FDA regulations regarding the manufacture and sale of its vaccines. This includes the requirements that Merck only sell vaccines to the CDC that are licensed by the FDA and manufactured in conformance with the FDA's current Good Manufacturing Procedures ("cGMP"). As discussed below, a vaccine that is not manufactured in conformance with the specifications upon which the government's approval is based -- such as diminished efficacy -- fails to comply with cGMP and thus violates the CDC purchase contract. As also described below, a vaccine that is mislabeled, misbranded or adulterated (such as with a package insert that represents an inflated efficacy rate) or falsely certified as compliant with the conditions of purchase, likewise violates the CDC purchase contract.

B. Merck's Duties to the FDA

113. Merck has ongoing duties to the FDA pursuant to the Public Health Service Act, the Food Drug and Cosmetics Act and FDA regulations that control the licensing, labeling and manufacture of vaccines. 21 USC § 301 et seq.; 42 USC § 262 et seq.

1. Merck's Duty to Disclose Diminished Efficacy

114. Vaccine manufacturers have an ongoing duty to report problems with efficacy. 21 CFR § 600.12(b).

115. Vaccine manufacturers also have an ongoing duty to manufacture vaccines in conformance with a cGMP. 21. CFR § 210.2. In order to ensure compliance with cGMP, vaccine manufacturers are required to test for safety, purity, and potency every lot of the vaccine to be sold. 21 CFR § 610. Per the specifications approved by the FDA for Merck's mumps vaccine, this means that the amount of attenuated virus Merck puts in its vaccine result in a minimum 95 percent efficacy. See 21 CFR § 600.3(s) (Potency is defined as the "[a]bility ... to effect a given result"). If a manufacturer learns of a deviation from the specifications (such as diminished efficacy), it has a duty to disclose that information to the FDA, fully investigate it and correct it. 21 CFR § 600.14; 21 USC § 331(c) and 21 CFR § 211.192. A vaccine that does not comply with these standards is considered an adulterated product that cannot legally be sold. 21 USC § 331(a).

116. Vaccine manufacturers also have an ongoing duty to report to the FDA all adverse experience events (such as diminished efficacy). See, 21 CFR § 600.80(j). The law also imposes additional reporting requirements for vaccines, such as Merck's mumps vaccine, used in the pediatric population. It requires vaccine manufacturers to submit annual reports of any post-marketing pediatric studies to, among other things, inform the FDA of whether new studies in the pediatric population have been initiated. These reports must include an analysis of available safety and efficacy data in the pediatric population, and an assessment of data needed to ensure appropriate labeling for the pediatric population. 21 CFR § 601.28.

2. Merck's Duty to Ensure That Its Mumps Vaccine Package Insert Is Neither False Nor Misleading

117. Vaccine manufacturers are at all times responsible for the content of their labeling, including their package insert. They are charged both with crafting adequate and accurate labeling and with ensuring that the information remains adequate and accurate. This includes an ongoing duty to self-monitor and update their labeling -- including all associated package inserts and information sheets -- when new information becomes available that causes the labeling to become inaccurate, false or misleading. 21 CFR § 601.12(f)(2) and 21 CFR § 201.56-57. A vaccine is deemed to be misbranded and mislabeled, and cannot be sold, if its labeling is "false or misleading in any particular." 21 USC §§ 352(a) and 331(a).

C. Merck's Duties to the National Vaccine Program

118. Merck also has duties under the National Childhood Vaccine Injury Act which created the National Vaccine Program and the Vaccine Injury Compensation Program. The two programs together were intended to create a simple, easy to administer system for vaccine injury compensation (which Merck wanted) and a more stable, competitive market for childhood vaccines which would lead to vaccine improvements (which the government wanted). The manufacturers were deemed stakeholders and enlisted to collaborate and cooperate with the government to improve the country's vaccination program. In exchange, under the Injury Compensation Program, Merck and other manufacturers obtained protection from liability for personal injury claims.

119. The Act also created a new system for manufacturers to report all "adverse events" related to vaccines reinforcing the reporting requirements otherwise triggered by the Public Health Service Act and the Food Drug and Cosmetics Act, described above. These adverse event reports are made on the Vaccine Adverse Event Reporting System and are supposed to encompass any problems associated with a vaccine including those associated with safety and efficacy. 42 USC § 300aa-25(b).

D. Merck's Duty to Be Truthful and Forthcoming In Its Dealings With the Government

120. Merck has a duty to be forthcoming and honest with federal officials in all of its dealings with the government. Specifically, under 18 USC § 1001, Merck is prohibited from knowingly and willfully: (1) falsifying, concealing, or covering up a material fact by any trick, scheme, or device; (2) making any materially false, fictitious, or fraudulent statement or representations; or (3) making or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry in any matter relating to the government.

E. Merck's Breach of These Multiple Duties to the Government

121. Merck breached all of the above duties by falsely representing that the efficacy rate of its mumps vaccine is 95 percent or higher and by taking affirmative steps to conceal the vaccine's diminished efficacy.

122. These duties were triggered as soon as Merck learned that the efficacy of its now forty-five year old mumps vaccine had diminished. Merck learned this no later than 1999 as evidenced by the admission by the head of the Merck team running the Protocol 007 testing, Krah. He even correctly predicted that the diminished efficacy of the vaccine would lead to the reemergence of mumps outbreaks. But rather than disclose this to the CDC, FDA or the appropriate individuals running the National Vaccine Program, as Merck was obligated to do, Merck instead embarked on a campaign of concealment and outright fraud.

123. First, Merck devised a scientifically flawed PRN test which attempted to measure the efficacy of its mumps vaccine based on how the vaccine performed against the less virulent vaccine strain of the virus rather than the wild-type strain that exists in the real world. Even using this scientifically dubious methodology, Merck saw that the seroconversion rate was significantly lower than the 95 percent efficacy rate that Merck was representing on its labeling and otherwise. Merck abandoned this methodology and its unfavorable results and kept them hidden rather than disclose them to the government.

124. Second, Merck devised an even more scientifically flawed PRN test when it "enhanced" its 1999 test with animal antibodies. The new methodology was not selected to provide a more accurate measure of the vaccine's efficacy. To the contrary, the methodology was concocted to measure a high seroconversion rate rather than an accurate one. To ensure that Merck's manipulation remained disguised, it falsified the test data to guarantee the pre-negative to post-positive change needed to achieve seroconversion. Having reached the desired, albeit falsified, efficacy threshold, Merck submitted these fraudulent results to the FDA (and the EMA in Europe), again breaching its multiple duties of open and honest disclosure to the government.

125. Third, Merck took steps to cover up the tracks of its fraudulent testing by destroying evidence of the falsification and lying to the FDA investigator that questioned Merck about the ongoing testing. Merck also attempted to buy the silence and cooperation of the staff involved in the testing by offering them financial incentives to follow the direction of the Merck personnel overseeing the fraudulent testing process. Merck also threatened Relator Krahling on numerous occasions with jail if he reported the fraud to the FDA.

126. Fourth, in 2004 Merck submitted the application for approval for ProQuad, certifying the contents of the application as true even though Merck knew the statements about the effectiveness of the mumps vaccine were, in fact, false. At no time during this application process did Merck disclose to the FDA the problems of which it was aware (or should have been aware) relating to the significantly diminished efficacy of its mumps vaccine. Accordingly, in 2005, the FDA approved Merck's application for ProQuad.

127. Fifth, Merck sought and secured FDA approval to change its MMRII labeling to reflect an almost 40 percent reduction in the minimum potency of the mumps vaccine component. It did this while leaving its false representations of efficacy unchanged. And it did this fully appreciating that if the current, higher potency vaccine had an efficacy rate far lower than the falsely represented 95 percent, there was no way the vaccine would achieve this efficacy with significantly less attenuated virus in each shot. Nevertheless, at no time during the course of obtaining the FDA's approval for the labeling change did Merck disclose to the FDA the problems of which it was aware (or should have been aware) relating to the significantly diminished efficacy of its vaccine. Nor did Merck disclose its knowledge that these problems would be greatly exacerbated if the potency in the dose was reduced.

128. Sixth, Merck continued to conceal what it knew (or should have known) about the diminished efficacy of its mumps vaccine even after the 2006 and 2009 mumps outbreaks. It did so even after the CDC -- with which Merck was supposedly working to determine the cause of the outbreaks -- publicly stated that there was nothing wrong with the vaccine.

129. Seventh, Merck has continued to conceal what it knows (or should know) about the diminished efficacy of its mumps vaccine even though the Immunization Action Coalition -- which Merck funds, and which the CDC also funds, supports and substantively contributes to -- prominently promotes an efficacy rate of 97 percent.

130. And eighth, despite what Merck knows (or should know) about the diminished efficacy of its mumps vaccine, Merck has fraudulently represented on its labeling a significantly inflated efficacy rate. Not only does this violate each of the multiple duties described above and make Merck's mumps vaccine a mislabeled, misbranded and adulterated product. This continuous misrepresentation falsely certifies to the government compliance with the terms of the contract pursuant to which the government buys Merck's vaccine.

131. Merck's broad-based scheme to falsely represent and conceal the diminished efficacy of its mumps vaccine violated the multiple duties it owes the government to report, investigate and attempt to correct any problems associated with the safety and efficacy of its vaccine, including its duty: (i) to the CDC, to provide accurate and up-to-date efficacy information and comply with cGMP requirements and not to sell mislabeled, misbranded or adulterated products; (ii) to the FDA, to provide accurate and up-to-date efficacy information, comply with cGMP requirements, fully and properly investigate, test, and correct any suspected problems with efficacy, and ensure the efficacy information reported on Merck's labeling is neither false nor misleading, (iii) under the National Vaccine Program, to report all "adverse events" related to its vaccines including problems associated with efficacy; and (iv) to the government generally, to be forthcoming and honest in all of Merck's dealings.

IN FRAUDULENTLY REPRESENTING AND OTHERWISE CONCEALING THE DIMINISHED EFFICACY OF ITS MUMPS VACCINE, MERCK HAS ILLEGALLY MONOPOLIZED THE MUMPS VACCINE MARKET

132. As the only company licensed by the government to sell mumps vaccine, Merck has had a monopoly in the U.S. market for mumps vaccine since it obtained its original license in 1967. However, Merck has maintained this monopoly not through its business acumen or its manufacture and sale of the best quality product. Instead, Merck has willfully and illegally maintained its monopoly through its ongoing misrepresentations of the efficacy of its mumps vaccine, and its violations of the multiple duties of disclosure it owes the government. Through this misconduct, Merck has been able to maintain a falsely inflated efficacy rate for its mumps vaccine and exclude competing manufacturers from entering the market.

A. The U.S. Market for Mumps Vaccine

133. The U.S. manufacture and sale of mumps vaccine (including Mumpsvax, MMRII and ProQuad) is a relevant antitrust market in this case. For those seeking immunization for mumps, a mumps vaccine is the only product available to achieve that result. So regardless of the price Merck charges for its mumps vaccine, the extent or frequency of any price increases for the vaccine, or whether Merck incorporates the vaccine into multi-disease vaccines, as it does with MMRII and ProQuad, there are no alternative products to which the government, health care professionals or consumers can turn to obtain this immunization.

134. The U.S. market for mumps vaccine is further defined by the CDC's nationwide schedule of recommended childhood vaccinations, including a vaccination against mumps, and the requirement around the country that all public school students be vaccinated against mumps (among other childhood diseases). If a child is to attend public school -- not to mention any private school, university, summer camp or other educational or recreational institution in this country -- he or she must take a mumps vaccine. There is no choice (but for rare exceptions). There is no alternative. No other products can substitute for this required vaccination.

B. Merck's Monopolization of the Market for Mumps Vaccine

135. Since it originally obtained government approval for the mumps vaccine in 1967, Merck has had a natural monopoly through its de facto exclusive license to sell the vaccine in this country. This has extended to multi-disease vaccines such as MMR, MMRII and ProQuad. But Merck has been able to maintain its monopoly not through providing the safest, most effective and most cost effective mumps vaccines in the market. Rather, Merck has maintained its monopoly by representing a falsely inflated efficacy rate of 95 percent or higher.

136. There are significant barriers to entry inherent in the manufacture and sale of a new vaccine. The research, development, testing and government approval process is very expensive, time-consuming and risky. Several years and millions of dollars might be spent on developing a vaccine only to find it fail in the final stages of testing, or to have the government refuse to approve it or significantly limit its application or distribution. Vaccine manufacturers will therefore invest in developing a new vaccine only where they se both a need for the vaccine and an opportunity to make a large enough return on the significant capital investment and risk involved.

137. In the case of the U.S. market for mumps vaccine, this inherent barrier to entry is substantially compounded by the falsely inflated efficacy rate of Merck's vaccine. As with the market for any product, a potential competitor's decision to enter a market hinges on whether its product can compete with those products already being sold in the market. If an existing vaccine is represented as safe and at least 95 percent effective, as Merck has falsely represented its vaccine to be, it would be economically irrational for a potential competitor to bring a new mumps vaccine to the market unless it thought it could compete with the safety and efficacy of the existing vaccine. No one would purchase it otherwise -- not the government, nor health care providers, nor consumers.

138. This is especially true for the federal government since its goal in purchasing vaccines is to allocate its resources to reduce and eliminate disease to the fullest extent possible. Using an inferior vaccine would significantly undermine the overarching purpose of the government funded immunization programs. It would specifically interfere with the government's goal, albeit unrealistic in light of Merck's defective vaccine, of eradicating mumps by the end of the decade.

C. Merck Has Maintained Its Monopoly By Foreclosing Competition

139. Through its false representations of the mumps vaccine's efficacy rate, its efforts to conceal the significantly lower efficacy rate that the Protocol 007 testing confirmed, and its repeated violations of the multiple duties of disclosure it owes the government, Merck has foreclosed potential competitors from entering the market with a new mumps vaccine. No manufacturer is going to sink the time, energy and resources into developing the vaccine for sale in the U.S. with the artificially high bar Merck has devised.

140. Entering the market would be particularly risky in the case of the mumps vaccine given the four-decade lock Merck has had on the market.

141. But for Merck's fraud and other misconduct, one or more competing manufacturers would have entered this lucrative market -- with its guaranteed sales of almost 8 million doses a year -- with a competing mumps vaccine. For example, GlaxoSmithKline, a manufacturer of numerous FDA approved vaccines, has an MMR vaccine, Priorix, that is widely sold in Europe, Canada, Australia and other markets. Priorix is not licensed or sold in the U.S.

142. By continuing to misrepresent an artificially high efficacy rate, and engaging in all the misconduct to conceal the diminished efficacy of its vaccine, Merck has foreclosed GlaxoSmithKline and any other manufacturer from entering the U.S. market for mumps vaccine. So long as Merck continues to engage in this misconduct, these manufacturers will continue to be excluded from the U.S. market and Merck will retain its unchallenged monopoly with a vaccine that does not provide adequate immunization.

D. Merck's Harm to Competition and the Government

143. Merck's misconduct has harmed competition by foreclosing other manufacturers from entering the U.S. market for mumps vaccine. Without such competition, Merck has been able to maintain its monopoly in this market even though it is manufacturing and selling a sub-par vaccine. In the absence of this foreclosure, other manufacturers would have entered the market with a higher quality and/or cheaper vaccine. This competition, or the threat of such competition, would have forced Merck to respond by either selling its existing vaccine at a lower price or developing a better vaccine.

144. Merck's misconduct has also harmed the government. It has caused the government to pay Merck hundreds of millions of dollars for a product that is not what Merck represents it to be and not what the government needs it to be. It has also deprived the government of a competitive market for mumps vaccine which would promote the development of new and better vaccines to improve the health of all Americans. And perhaps most importantly, it has significantly undermined the government's efforts to protect the public against a resurgence of mumps. Outbreaks of the disease have increased and threaten to continue and grow larger. And the original target date for eradication of the disease has long since passed.

THE UNITED STATES' PAYMENT OF HUNDREDS OF MILLIONS OF DOLLARS FOR A VACCINE THAT DOES NOT PROVIDE ADEQUATE IMMUNIZATION

145. Over the past decade, Merck's fraudulent scheme to misrepresent the efficacy of its mumps vaccine has cost the U.S. hundreds of millions of dollars through the government's annual purchases of the vaccine under the National Vaccine Program. Had Merck complied with the U.S. antitrust laws and with its multiple duties of disclosure and reported the diminished efficacy of its vaccine -- rather than engage in fraud and concealment -- it would have affected (or certainly had the potential to affect) the government's decision to purchase the vaccine. The government would have had the opportunity to consider numerous options. For MMRII this would include not purchasing the vaccine from Merck, paying less, requiring a labeling change, requiring additional testing, or prioritizing development and approval of a new vaccine (per the mandate of the National Vaccine Program). For ProQuad this would include not licensing the vaccine at all.

146. But Merck did not comply with these duties of disclosure or with the antitrust laws. Instead, it took pains to maintain its fraudulently inflated efficacy rate and its monopoly grip on the market so it could foist on the government a vaccine without sufficient immunizing effect. In other words, over the past decade, through its scheme of fraud and concealment, Merck has sold the government a vaccine that (i) is mislabeled, misbranded, adulterated and falsely certified; and (ii) does not comply with the FDA's labeling, reporting and testing requirements; with the CDC's reporting requirements; with the cGMP standards required by the CDC contract and the FDA; and with the requirements of the National Vaccine Program to report any vaccine failure.

147. The CDC plays the critical role of making the government's vaccine purchasing decisions. It is responsible for entering into the contracts with the manufacturers, deciding which vaccines to purchase, providing information on safety and efficacy to health care providers and the public, and promoting the benefits of widespread immunization. The CDC purchases vaccines in batches of varying size throughout the year for administration to the public. As negotiated, Merck ships its vaccines to the CDC's designated repositories. Merck thereafter submits a claim for payment which the CDC subsequently pays.

148. The CDC annually purchases from Merck anywhere from roughly $60 million to $76 million of its MMRII vaccine. This comes from the following approximate calculation:

4 million (annual number of U.S. births)
x
.95 (childhood vaccination rate)
x
2 (number of doses per vaccinated child)
x
.52 (rate of vaccine spending attributed to CDC)
x
15 to 19.33 (dollar price range of MMRII dose from 2000 to present)

The mumps component of the MMRII vaccine represents about 40 percent of the vaccine's total cost.

149. Since 2000, the CDC has thus paid Merck more than $700 million for its MMRII vaccine to be administered to children. These amounts likely underestimate the CDC's total purchases because they do not account for purchases of ProQuad, which is significantly more expensive than MMRII, Mumpsvax, or purchases of adult doses of Mumpsvax, MMRII and ProQuad, which Merck also sells to the CDC. Over this period, the U.S. has therefore paid more than three-quarters of a billion dollars for a mislabeled, misbranded, adulterated and falsely certified vaccine that does not provide adequate immunization.

CLAIM FOR RELIEF (Merck's Violation of the False Claims Act)

150. Relators reallege and incorporate by reference all of the allegations set forth herein.

151. This is a claim for treble damages and penalties under the False Claims Act, 31 U.S.C. § 3729, et seq., as amended.

152. As set forth above, in violation of 31 U.S.C. § 3729(a)(1), Merck knowingly presented, or caused to be presented, to the United States government, false or fraudulent claims for payment or approval when it billed the government for its purchases of a mumps vaccine that, among other things, (i) was significantly less effective than Merck represented it to be, (ii) did not provide the product the government contracted to purchase, (iii) was mislabeled, misbranded, adulterated and falsely certified and (iv) was exclusively supplied to the government by Merck because of Merck's illegal monopolization of the mumps market.

153. In addition, at least for conduct occurring on or after May 20, 2009, Merck violated 31 U.S.C. § 3729(a)(1)(A) (formally 31 U.S.C. § 3729(a)(1) as amended by the Fraud Enforcement and Recovery Act of 2009) by knowingly presenting or causing to be presented false or fraudulent claims for payment or approval when Merck billed the government for its purchases of a mumps vaccine that, among other things, (i) was significantly less effective than Merck represented it to be, (ii) did not provide the product the government contracted to purchase, (iii) was mislabeled, misbranded, adulterated and falsely certified and (iv) was exclusively supplied to the government by Merck because of Merck's illegal monopolization of the mumps market.

154. As set forth above, in violation of 31 U.S.C. § 3729(a)(2), Merck also knowingly made, used, or caused to be made or used, false records or statements to obtain payment or approval by the government of Merck's false or fraudulent claims for purchases of its mumps vaccine when Merck, among other things: (i) failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment described herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy in the vaccine the government was purchasing. Merck engaged in all of this misconduct to maintain its monopoly of the U.S. market for mumps vaccines and to secure continued payment by the government of Merck's false or fraudulent claims for its sales of the mumps vaccine.

155. In addition, at least for false or fraudulent claims pending or made on or after June 7, 2008, Merck violated 31 U.S.C. § 3729(a)(1)(B) (formally 31 U.S.C. § 3729(a)(2) as amended by the Fraud Enforcement and Recovery Act of 2009) when Merck knowingly made, used, or caused to be made or used, false records or statements material to its false or fraudulent claims when Merck, among other things: (i) failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment described herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing.

156. These false statements, records, and data, and Merck's multiple failures to comply with its various duties of disclosure, investigation, testing and reporting, were material to the government's purchases of and payments for Merck's vaccine, and the CDC's long-standing recommendation to have the public vaccinated with Merck's mumps vaccine. This materiality is reflected in:

• Merck's contractual and statutory duties to disclose to the government all information regarding the safety and efficacy of its mumps vaccine;

• Merck's multiple intentional violations of these duties;

• The CDC's responsibility to ensure that all vaccines manufactured and sold in the U.S. are safe and effective;

• The FDA's responsibility to ensure that all vaccines manufactured and sold in the U.S. are safe and effective;

• The National Vaccine Program's responsibility to ensure that all vaccines manufactured and sold in the U.S. are safe and effective;

• The CDC's responsibility to provide health care professionals and the public with accurate and up-to-date information on the safety and efficacy of vaccines;

• Merck's decision to conduct PRN testing of its mumps vaccine which would be reported to the FDA;

• Merck's abandonment of the 1999 PRN methodology in favor of a methodology that would yield better results;

• Merck's improper use of animal antibodies in its "enhanced" PRN test to artificially boost its seroconversion results;

• Merck's falsification of pre-positive test data to report the results it wanted using the animal antibodies in its testing;

• The CDC's continued belief in the faces of the 2006 outbreak that there was nothing wrong with Merck's vaccine and that it should continue to be used;

• The call by at least one CDC doctor for a new vaccine if the Merck vaccine was not effective in preventing outbreaks;

• The prominent publication of inaccurate mumps efficacy information by the Immunization Action Coalition

• Merck's continuing efforts to improperly maintain its monopoly of the U.S. market for mumps vaccine through its false representation of an inflated efficacy rate; and ultimately

• Merck's own recognition that it would lose its exclusive license to sell mumps vaccine if it did not measure and report at least a 95 percent seroconversion rate in the mumps efficacy testing conducted in Krah's lab under Protocol 007.

157. Each representation Merck made to the government asserting that its mumps vaccine was at least 95 percent effective, including through its product package inserts, the reporting of its fabricated test results, and otherwise, as described above, constituted a false statement or record. Likewise, each invoice Merck submitted, or caused to be submitted, to the government for payment for the purchase of the vaccines, constituted a false or fraudulent claim for payment. Relators cannot identify at this time all of the false claims for payment caused by Merck's unlawful conduct because they were submitted at numerous times under various requests between 200 and the present.

158. To the extent that the facts alleged in this Complaint have been previously disclosed to the public or the government in any fashion, Relators are each an "original source" of the information as defined in 31 U.S.C. § 3730(e)(4).

159. The United States government, the public, and the public treasury have been damaged by and continue to be damaged by Merck's fraudulent conduct.

160. In addition, Merck's fraudulent conduct may be in violation of a 2008 Corporate Integrity Agreement that Merck entered into with the Office of Inspector General of the Department of Health and Human Services. Merck entered into this agreement as part of its settlement with the United States to resolve prior unrelated False Claims Act litigation. As part of this agreement, Merck is obligated to promote its "products (including vaccines) that are reimbursed by Federal health care programs" in compliance with the federal program requirements.

PRAYER FOR RELIEF

Wherefore Relators requests the following relief:



A. That Merck cease and desist from violating 31 U.S.C. § 3729, et seq.;

B. That the Court enter judgment against Merck in an amount equal to three times the damages suffered by the United States due to Merck's unlawful conduct;

C. That the Court enter judgment against Merck assessing a civil penalty of no less than $5,500 and no more than $11,000 for each violation of 31 U.S.C. § 3729;

D. That Relators receive the maximum award allowed by 31 U.S.C. § 3730(d);

E. That Relators be awarded all costs of this action, including attorneys' fees, costs, and expenses pursuant to 31 U.S.C. § 3730(d);

F. That the Court award pre and post-judgment interest on any damages awarded to the United States or Relators; and

G. That the United States and Relators be awarded all such other relief that the Court deems just and proper.

JURY DEMAND

Relators hereby demand a trial by jury.

Dated: April 27, 2012

Keller Grover LLP

Jeffrey F. Keller
Kathleen R. Scanlan
1965 Market Streest
San Francisco, CA 94103
Tel: (415) 543-1305
Fax (415) 543-7861

Wasserman, Comden, Casselman & Esensten, L.L.P.

Melissa Harnett
5567 Reseda Blvd., Suite 330
Tarzana, CA 91356
Tel: (818) 705-6800
Fax: (818) 345-0162

Schlam Stone & Dolan LLP

Robert L. Begleiter
26 Broadway, 19th Floor
New York, NY 10004
Tel: (212) 344-5400
Fax: (212) 344-7677

Counsel for Relators
Stephen A. Krahling
Joan A. Wlochowski

Meredith & Associates

Joel C. Meredith
1521 Locust Street, 8th Floor
Philadelphia, PA 19102
Tel: 215-564-5182
Fax: 215-569-0958

Constantine Cannon LLP

Gordon Schnell
Jeffrey I. Shinder
Jason Enzler
Marlene Koury
335 Madison Ave.
New York, NY 10017
Tel: (212) 350-2700
Fax: (212) 350-2701

______________

Notes:

1. Mumps vaccine used herein refers to any of Merck's vaccines containing a mumps component such as MMR, MMRII and ProQuad.

[admin]

VAXXED documentary: Official announcement from the producers unveils mass media cover-up of the 'suppression of medical data' by the CDC
by Mike Adams, the Health Ranger
March 30, 2016

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.

(NaturalNews) Cinema Libre Studio will be distributing Vaxxed: From Cover-Up to Catastrophe, the explosive documentary directed by Andrew Wakefield which was "de-selected" from the Tribeca Film Festival this past weekend.

The film investigates the claims of a Senior Scientist at the U.S. Centers for Disease Control and Prevention (CDC), Dr. William Thompson, who revealed that the CDC had manipulated and destroyed data on an important study about autism and the MMR (measles, mumps and rubella) vaccine.

Cinema Libre Studio has been working with the Vaxxed team since fall of 2015, and has acquired worldwide rights from Autism Media Channel. The documentary will premiere Friday, April 1 in an Exclusive Engagement at the Angelika FiIm Center in New York City before being widely released in other cities with future distribution plans to be unveiled.



The film was an Official Selection at the Tribeca Film Festival with the world premiere scheduled for April 24th. However, after the film was announced in the lineup last Monday, online protests erupted. Then festival co-founder Robert De Niro had a one-hour conversation with Representative Bill Posey, who appears in the film and who has vetted all communication related to the CDC whistleblower and asked that he be brought before Congress to testify. After the call, a statement was posted on the Tribeca Facebook page from De Niro:

"This is very personal to me and my family and I want there to be a discussion, which is why we will be screening VAXXED. I am not personally endorsing the film, nor am I anti-vaccination; I am only providing the opportunity for a conversation around the issue."

The pressure mounted when the story went viral and the festival made an about-face, when TFF executives called Cinema Libre Studio executives over the holiday weekend to tell them the film was being pulled from the line-up. De Niro then posted a second statement saying:

"My intent in screening this film was to provide an opportunity for conversation around an issue that is deeply personal to me and my family. But after reviewing it over the past few days with the Tribeca Film Festival team and others from the scientific community, we do not believe it contributes to or furthers the discussion I had hoped for."

The media frenzy continued including a Change.org petition to bring back the film to the festival which now has over 28,000 signatures.

Since 1986, the National Vaccine Injury Compensation Program (VICP) has been compensating children and adults who are victims of vaccine injury including but not limited to: injuries, learning disabilities, severe/permanent disabilities, AUTISM, and death.

They have been compensating for AUTISM cases resulting from vaccine injury. If vaccines don't cause autism, why is it being proven in court rulings, and why are they paying these cases out if they don't? Because vaccines DO harm, they DO injure, and they DO kill, and......they DO cause autism.

Source: http://www.nvic.org/injury-compensation.aspx "By 2010, the U.S. Court of Claims had awarded nearly $3 billion dollars to vaccine victims for their catastrophic vaccine injuries, although two out of three applicants have been denied compensation."

In 2013, biologist Dr. Brian Hooker received a call from a Senior Scientist at the U.S. Centers for Disease Control and Prevention (CDC) who led the agency’s 2004 study on the Measles-Mumps-Rubella (MMR) vaccine and its link to autism. The scientist, Dr. William Thompson, confessed that the CDC had omitted crucial data in their final report that revealed a causal relationship between the MMR vaccine and autism.

Over several months, Dr. Hooker records the phone calls made to him by Dr. Thompson who provides the confidential data destroyed by his colleagues at the CDC. Dr. Hooker enlists the help of Dr. Andrew Wakefield, the British gastroenterologist falsely accused of starting the anti-vax movement when he first reported in 1998 that the MMR vaccine may cause autism. In his ongoing effort to advocate for children’s health, Wakefield directs this documentary examining the evidence behind an appalling cover-up committed by the government agency charged with protecting the health of American citizens. Interviews with pharmaceutical insiders, doctors, politicians, and parents of vaccine-injured children reveal an alarming deception that has contributed to the skyrocketing increase of autism and potentially the most catastrophic epidemic of our lifetime.

Blackfish was screened at Tribeca, and look at the movement it caused. Because of Tribeca, and because of the amazing people who documented what was happening at SeaWorld, SeaWorld recognized the need for change, and they changed because the world needed them to.

Pharmaceutical companies are afraid that if people start to question vaccines (and rightfully so) they will lose BILLIONS in profits. Well, they've already made BILLIONS off of us, injuring and killing our children for their "greater good" and it's time for it to end. Look at a vaccine insert and the lists and pages of debilitating side effects including death and tell me that they are "SAFE." No one inherently looks at a vaccine insert that lists death and permanent injury and thinks "yeah, that sounds safe." Go ahead, look.

People argue that if people start to question vaccines, it will jeopardize the safety of children. BECAUSE of the cover-up, we have already done that. Now it's time to set things right, and hold the correct people responsible.

SUPPORT VAXXED

SUPPORT TRIBECA

The CDC RELEASED documents can be found as well as a link to the story here:

http://truthinmedia.com/truth-in-media- ... documents/

VAXXED the movie trailer can be found here: http://vaxxedthemovie.com/

Congressman Posey on throwing the studies in a garbage can to get rid of the evidence: https://www.youtube.com/watch?v=jGRjn_gIJw0

Dan Burton demanding a yes or no from the FDA for a vaccine link to Autism: https://www.youtube.com/watch?v=Yd3xdAp9_Zk

For Vaccine injury stories/videos and educational information please visit: http://www.stopmandatoryvaccination.com/ and https://www.learntherisk.org

-- Bring VAXXED back to Tribeca, Petition at Change.org

The "suppression of medical data by a governmental agency"

Cinema Libre Chairman Philippe Diaz says, "We chose to distribute this film to correct a major issue, which is the suppression of medical data by a governmental agency that may very well be contributing to a significant health crisis. The media storm of last week also revealed another issue; the hyper mediatization by some members of the media and the documentary community who had not even seen the film, as well as Tribeca executives, which condemned it as anti-vaccine. This film is not anti-vaccine and neither is Dr. Wakefield. Wakefield's concern for the last twenty years has been about making sure that vaccines are safe for children. This is why we decided to release the film now rather than as originally planned later in the year."

Richard Castro, Head of Distribution, explains, "It's disturbing that an American film festival can succumb so easily to pressure to censor a film that it has already selected and announced. On Friday I received a call from Tribeca executives expressing concerns about showing the film, but no opportunity was afforded our filmmakers to even address those concerns. When I questioned the rationale, it was indicated that sponsors interest was a factor. By Saturday night, the film was simply pulled off the festival's programming schedule."

Produced by Del Bigtree, who left his job as producer on the Emmy award-winning television show The Doctors to make the film, the documentary features Dr. Brian Hooker, to whom Thompson leaked documents as well as autism experts (Dr. Doreen Granpeesheh, Mark Blaxill, Polly Tommey), practicing family physicians (Dr. James M. Sears, Dr. Rachel Ross), former Pharmaceutical drug representative Brandy Vaughn, research scientists (Dr. Luc Montagnier, Stephanie Seneff) and Congressman Bill Posey.

Says Bigtree, "While making the film, we spoke to so many medical professionals who are afraid to speak out publicly against the pharmaceutical companies, and their influence on the medical industry. When the CDC Whistleblower story broke last year, not one mainstream news outlet ran the story. Either they were asleep at the wheel or were in a coma induced by their pharmaceutical advertisers."

Wakefield says, "Our aim with this movie was to take this complex, high-level fraud and to give it context, and weave through it the tragic street-level narratives of ordinary families affected by autism. We hope that the film will help, at a minimum, push Congress to subpoena Dr. William Thompson and investigate this fraud at the CDC."

The film was produced by Del Bigtree, edited by Brian Burrowes with original music by Franceso Lupica (Knights of Cups, Tree of Life) who has contributed his "Visual Music Design" to several Terrance Malick films. The film was financed through donations of individual families and philanthropists, and was acquired from Autism Media Channel in a deal negotiated by Wakefield for Autism Media Channel and Bigtree with Richard Castro.

Website: http://www.vaxxedthemovie.com
Facebook: https://www.facebook.com/vaxxedthemovie
Twitter: @vaxxedthemovie #vaxxed #cdcwhistleblower

ABOUT CINEMA LIBRE: Cinema Libre Studio is a full-service mini-studio known for producing and distributing high concept feature films and social impact documentaries. Headquartered in the Los Angeles area, the team has released over 200 films.

http://www.cinemalibrestudio.com
http://www.facebook.com/cinemalibrestudio.com
twitter.com/cinemalibrestudio

[admin]

What Media Hid in De Niro Autism Film Affair
by William Engdahl
August 6, 2016

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.

Dr. Andrew Wakefield, a former British gastro-enterologist and vaccine researcher has been fully exonerated of the charges that he, together with a world renowned pediatric gastroenterologist, Prof. John Walker-Smith, conducted fraudulent tests with children that raised the possibility of a link between the popular MMR (measles, mumps, rubella) vaccine and onset of autism and other severe symptoms. Most remarkable is the fact that despite his de facto exoneration in a British Court more than four years ago, in 2012, mainstream media in the UK and the USA have chosen to deliberately ignore the fact. They did so to hide the explosive content of Wakefield’s film, Vaxxed.

This past April, Hollywood actor and founder of the Tribeca film festival, Robert de Niro, announced in an interview to the New York Times that he had personally arranged for a new documentary film, Vaxxed, about links between autism and vaccinations, to be shown on April 24 at his festival in order to open a national debate on the subject. Some 48 hours later the Tribeca website announced it had pulled the film. The pressure had been enormous. To his credit, some days later, on America’s most popular morning show, de Niro repeated his earlier statement that while he is not anti-vaccine, he wants an open debate on the subject. De Niro’s own son is autistic.

Exonerated

At the time I wrote my article, I was not aware that a British Court some four years ago completely exonerated Wakefield’s co-author and researcher in the autism study. Since then a helpful reader has pointed me to the entire text of the Court decision. I’ve decided to write this follow-up in the interest of justice to Andrew Wakefield, whom I’ve personally met and whose moral courage going up against the pharma lobby against all normal odds we owe a debt to. I do it also in support of Robert de Niro’s call for an open debate on the question of links between not only autism and vaccines. Had our “mainstream” media not been long ago polluted with the toxic waste of the pharma industry, and had they maintained a scintilla of honest journalism today, such an account would not have been necessary.

In February, 2012, Mr. Justice Mitting held hearings on the charges brought against world renowned pediatric gastro-enterologist, Prof. John Walker-Smith, Wakefield’s co-researcher, in Britain’s High Court of Justice, Queen’s Bench Division, Administrative Court.

The Justice ruled that charges brought against Walker-Smith by the British General Medical Council’s Panel, the GMC “panel’s determination cannot stand. I therefore quash it.” Walker-Smith won his appeal against a General Medical Council regulatory board that had ruled against both him and Andrew Wakefield for their roles in authoring a 1998 Lancet MMR paper, which raised questions about a link to autism. The complete victory means that Walker-Smith has been returned to the status of a fully licensed physician…”

Astonishingly, as the judge pointed out, the conclusions of the GMC board that stripped both Walker-Smith and Wakefield of their licenses to practice medicine in the UK were based on “inadequate and superficial reasoning and, in a number of instances, a wrong conclusion… The end result is that the finding of serious professional misconduct and the sanction of erasure are both quashed.” He notes that the board’s trial of Walker-Smith and Wakefield had no actual complainants, no harm came to the children who were studied, and parents supported Walker-Smith and Wakefield through the trial, reporting that their children had medically benefited from the treatment they received at the Royal Free Hospital.

Dr. Andrew Wakefield was not party to the Walker-Smith appeal process. Walker-Smith’s insurer had agreed to fund his costly appeal. Dr. Wakefield’s insurer refused, and Wakefield was financially unable to join the appeal. The judge’s full exoneration of Walker-Smith in the matter of the Lancet study he published together with Wakefield, exonerates the content of the Lancet paper and of Andrew Wakefield. The article both co-authored was grounds for their losing medical licenses. On learning of the Walker-Smith exoneration in 2012, Wakefield, from his new residence in Texas, filed a defamation lawsuit against the British Medical Journal and three individuals for falsely accusing him of “fraud.”

The Lancet study which Professor Walker-Smith and Dr. Andrew Wakefield co-authored, never asserted a causal link between the MMR vaccine of Glaxo SmithKline and autism. They rather suggested a serious study should be undertaken. Their Lancet article was removed after the 2010 British General Medical Council’s trial. Lancet is owned by the large Elsevier Group, whose Chairman had been named to the board of Glaxo SmithKline, major producer of MMR vaccines, in 2003.

In the latest media attack campaign, led by The New York Times, the UK Guardian and other mainstream media, focus was on one fact only: That Robert de Niro had organized a screening of the documentary, Vaxxed, directed by Wakefield. As the Guardian sub-titled their article, “Actor criticized for adding doc by Andrew Wakefield, who was struck off UK medical register…”

CDC autism test fraud–the deeper media cover-up

However, the deeper cover-up by the mainstream media, was their refusal to write one word about the explosive content that Wakefield’s documentary focused on. Had they done that, Glaxo SmithKline (GSK), the world’s largest seller of vaccines, conceivably could today be in bankruptcy proceedings along with other makers of MMR vaccines.

Wakefield’s Vaxxed documents that “the CDC (US Government’s Centers for Disease Control-w.e.) deliberately and willfully concealed a significantly increased autism risk associated with receipt of MMR vaccine according to the CDC’s recommended schedule (by 18 months) in vulnerable subgroups of children i.e. African American boys and children with ‘isolated’ autism who were essentially previously developmentally normal. As a consequence, millions of American children have been put in harm’s way.” (emphasis added-w.e.)

The film’s content, which features “interviews with pharmaceutical insiders, doctors, politicians, and parents of vaccine-injured children,” contains the testimony of CDC whistleblower, Senior Scientist Dr. William Thompson who led the CDC agency’s 2004 study on the Measles-Mumps-Rubella (MMR) vaccine and its link to autism. Wakefield’s film details the history from the point in 2013 when Thompson, evidently seized by conscience, approached biologist Dr. Brian Hooker by phone. Thompson “confessed that the CDC had omitted crucial data in their final report that revealed a causal relationship between the MMR vaccine and autism.” (emphasis added-w.e.)

In a series of phone discussions in 2015 with US Congressman Bill Posey, Thompson described (all on tape) that while he was a senior scientist at CDC, he and his colleagues, after making a study of the link between vaccines and incidence of autism in small black boys, “scheduled a meeting to destroy documents related to the study. The remaining four co-authors all met and brought a big garbage can into the meeting room, and reviewed and went through all the hardcopy documents that we had thought we should discard, and put them into a huge garbage can.” Thompson is quoted declaring, “Oh my God! I cannot believe we did what we did. But we did.”

In the movie Dr. Hooker states how he recorded the phone calls made to him over several months, by Dr. Thompson, who provided the confidential data destroyed by his CDC colleagues. The film calls for Congress to subpoena Dr. William Thompson and investigate the CDC fraud, and for Congress to repeal the 1986 National Childhood Vaccine Injury Act that frees vaccine makers from liability and hold manufacturers liable for injury caused by their vaccines.

This criminal cover-up by the CDC, the government agency mandated to protect the health and safety of Americans, is the real focus of the Robert de Niro-Wakefield Vaxxed drama. DeNiro stated that he had familiarized himself with the William Thompson CDC case in detail before deciding to include Vaxxed in his film festival. De Niro had spoken at length with US Congressman Bill Posey, about Posey’s tape-recorded phone talks with CDC Whistleblower Thompson.

Rockefeller (Un-)Sanitary Commission

The website of the Rockefeller Foundation posted its 100-year Centenary of the founding of the Rockefeller Sanitary Commission (RSC) in 2009. Standard Oil magnate John D. Rockefeller had founded the commission in 1909 initially, as they describe,“…to bring about a co-operative movement of the medical profession, public health officials, boards of trade, churches, schools, the press and other agencies for the cure and prevention of hookworm disease.” Hookworm eradication, as the Rockefeller Foundation today admits, was simply a “favorable wedge,” allowing the RSC to promote the creation of an organized and well-funded public health network…”

The Rockefeller Foundation (RF) began in the 1920’s to organize a complete reorganization of American medical education, basing it on pharmaceuticals and surgery while discrediting or demonizing numerous alternative approaches. It was in effect doing in the medical area what the Standard Oil group had done in world oil -- dominate it.

As the RF then details in its website, they were responsible for the major turn by the WHO, CDC and others in the 1980’s to advocate very early and very massive multiple vaccinations of infants:

“RF’s global efforts to provide childhood vaccines began in 1984, following an international meeting at the RF conference center in Bellagio, Italy, on the protection of the world’s children. International delegates from the fields of medicine, government and philanthropy met to discuss the concept of a global immunization program for children as one means of providing primary health care and reducing mortality among children in the developing world. The World Health Organization (WHO) had already initiated the Expanded Program on Immunization (EPI) in 1980; however, in later years, the program had suffered from financial constraints. The Bellagio meeting resulted in hundreds of millions of dollars in funding allocated to the EPI.”

However the really explosive jump in early childhood and even infant multiple vaccinations took place when the Rockefeller Foundation and their Children’s Vaccine Initiative teamed up with the billions of dollars of the Bill and Melinda Gates Foundation, founded in 1994. At a 1999 World Bank Summit, again in the Rockefellers’ Bellagio center, senior staff of the RF, the Gates Foundation, WHO, World Bank and UNICEF. They agreed to create and fund a new organization to replace the CVI, the Global Alliance for Vaccines and Immunization (GAVI) in 2000.

This brief history is crucial in the context of the astonishing number of vaccinations given on recommendation of the WHO and the US CDC since precisely the mid-1980’s when the Rockefeller Foundation launched the project. Incidentally, the same foundation was deeply into launch of the GMO project at the same time, together with Monsanto where a Rockefeller sat on the board.

Precisely it was since the 1980’s, when the Rockefeller vaccine initiative was launched, that the alarming rise of child autism began to manifest. Most recently, USA autism rates climbed nearly 30% between 2008 and 2010. Incidents of child autism have more than doubled since 2000 according to a new study from the US Centers for Disease Control and Prevention, affecting one of every 68 children who are 8-year-olds. Thirty years ago autism in the USA was virtually unheard of. When it was first described in 1943 by Leo Kanner, it was believed to occur at a rate of 4–5 per 10,000 children. Today, it is 1 in 68!

The CDC claims not to know the cause.

It’s clearly not genetic change because such changes take many generations to manifest. Therefore it must be a significant change in the environment of the children. The most significant environmental change since the 1980’s in the USA, where it is well-documented, has been the intensity and frequency of child, and now infant, multiple vaccinations, all including MMR.

Alarming Ratajczak Studies

In 2011, Dr. Helen Ratajczak, herself a former senior scientist in the pharmaceutical industry, published a ground-breaking article in the Journal of Immunotoxicology entitled “Theoretical aspects of autism: Causes -- A review.” Ratajczak did what nobody else apparently had bothered to do: she reviewed the body of published science since autism was first described in 1943. Not just one theory suggested by research such as the role of MMR shots, or the mercury preservative thimerosal; but all of them.

Ratajczak’s article states, in part, that “Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis [brain damage] following vaccination. Therefore, autism is the result of genetic defects and/or inflammation of the brain.” xviii [emphasis added]

In a detailed interview with Vactruth.com, Dr. Ratajczak described the situation today in terms of infant exposure to multiple vaccines, the agenda of the same CDC that faked vaccine-autism data to be pharma-friendly.

She noted, “In the USA, in 2010, 50 doses of 14 vaccines are given by the age of six years with Hip B given at birth, and again at 2 months along with Rotavirus, Diphtheria, Tetanus, Pertussis (three vaccines in one injection), Homophiles influenza type b, pneumococcal, and inactivated poliovirus. Two months is the most vulnerable age immunologically. Most infant mortality occurs at 2 months because the protection from the mother’s immunity is waning, and the child’s immunity is still immature.”

Dr Ratajczak continues with this alarming observation from her years of research, “Thus, the immune system is compromised at two months. A challenge by so many vaccines while the immune system is compromised might contribute to an onset of autism (Ratajczak, 2011). The inflammation caused by the vaccines would damage the central nervous system and brain.”

She points to several documented studies of the effect of delaying child vaccination until after 2 years: “In Japan, some doctors gave no vaccines to infants for two months, and then began vaccinations only to children 2 years old or older. Japan jumped from 17th place in child mortality to the lowest child mortality in the world (Vaccine Awareness Network, 05 May, 2011). Similar results happened in other countries, such as the United Kingdom. The post-neonatal mortality dropped in 1976 when there was publicity about the whooping cough vaccine causing brain damage, and the vaccination rate fell to only 10 – 30%, with a concomitant fall in infant mortality rate.”

A compromising video

A recent French TV documentary program, “Special Envoy,” revealed that in France since 2015 parents who by law are required to vaccinate their children for diphtheria, tetanus and polio, can only do so by giving their child multi-vaccines marketed by GlaxoSmithKline as Hexavalent vaccine, or in liquid form by Sanofi Pasteur called Hexavac.

The TV program obtained an explosive video from June 2012, which shows Jean Stéphenne, former director of the GSK’s vaccine department, boasting of his success in a presentation. He explains the GSK strategy as follows: “We bought all the patents on hepatitis B. It was the first time a vaccine was protected by patents, so we have all patents. And now you competitors, if you want to come on the market, you have to negotiate with us… one includes [patented] hepatitis B with other “products” that were not protected by patents, and by doing that the product is made fully protected. So the strategy is not more complicated than that [applause].” The previous DTP (Diphteria, Tetanus, Poliomyelitis) cost 24 euros. The “hexavalent” vaccine costs 120 euros. The French TV program asks if the GSK patent strategy was driven by genuine health concerns or by profit.

There is perhaps no greater harm done today to human beings than that being promoted by the pharmaceutical industry and its ability to win friends and influence politicians, to pass friendly laws and to persuade mainstream media to hide the horrendous and mounting toll of vaccine damage to infants. I have had personal occasion in clinics in Germany to see what vaccine damage can do to children. It’s hushed up. It’s very, very real.

Despite the fact that Andrew Wakefield’s Vaxxed was pulled at the last minute, Robert de Niro has done the world a great service, alone through the media firestorm the film has generated, by placing attention on the work of Wakefield and the urgent need for an international spotlight on possible links between vaccinations, especially the multiple MMR vaccine, and illnesses such as autism. Instead of shooting the messenger, Andrew Wakefield, honest journalism could discuss the content of the Wakefield documentary. It’s very sobering.

F. William Engdahl is strategic risk consultant and lecturer, he holds a degree in politics from Princeton University and is a best-selling author on oil and geopolitics, exclusively for the online magazine “New Eastern Outlook”