FDA Cover-up? New Data Obtained Shows MMR Vaccine Approved on Clinical Trials of Only 342 Children – Half Suffered Side Effects

As we have previously reported here on Health Impact News, pharmaceutical giant Merck has been fighting a criminal case regarding its MMR (Measles, Mumps, Rubella) vaccine in court for over 8 years, as their own scientists became whistle-blowers regarding fraud in the development of the vaccine. Now, Del Bigtree, founder of the non-profit Informed Consent Action Network (ICAN), has announced that a new Freedom of Information Act disclosure from the Federal Food and Drug Administration (FDA) has revealed that the MMR vaccine was licensed based on clinical trials which in total had less than 1,000 participants, and only 342 children. “Thanks to the laws in this country that for now at least permit access to various government records, we now know the MMR vaccine was licensed using an irresponsibly small and limited group of children,” says Bigtree. “But what’s even more alarming is learning about the serious adverse events that were known and acknowledged, yet ignored in order to license the MMR vaccine,” Bigtree adds, noting “This was after only tracking adverse events for 42 days after injection – imagine what they might have found had they tracked safety for three years against an appropriate control, like they do for drugs.”

FDA Committee Chair: “Congress is Owned by Pharma”

Dr. Raeford Brown is a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital. He also chairs the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics. Dr. Brown has been openly critical of the FDA and their lack of oversight on the pharmaceutical industry, claiming "Congress is owned by pharma.” His comments were recently reported by Adriana Belmonte at Yahoo Finance. "Pharmaceutical companies are under the spotlight with congressional hearings on the cost of drug prices and allegations of the industry’s role in the opioid crisis. Dr. Raeford Brown, a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital and chair of the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics, has been openly critical of big pharma and the lack of proper oversight from the FDA. Despite many politicians, particularly declared presidential candidates, beginning to speak out against big pharma, Brown does not think that anything will come out of it 'because Congress is owned by pharma.'" The article documents how pharmaceutical companies are making significant financial contributions to politicians and political candidates. Statistics are based on OpenSecrets, a website operated by the nonpartisan Center for Responsive Politics, which tracks money in U.S. politics. “The pharmaceutical industry pours millions of dollars into the legislative branch every single year,” he told Yahoo Finance. “In 2016, they put $100 million into the elections. That’s a ton of money.” Dr. Brown went on to say: “I’m really much more concerned because Congress is supposed to have oversight for the FDA. If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress.”

Will New FDA Approval of Gardasil Vaccine for Adults Lead to Mandatory Gardasil Vaccination?

After the U.S. Food and Drug Administration’s (FDA) approved Merck’s HPV-9 Gardasil vaccine for use in adults age 27 to 45 in 2018, the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) of the Department of Health and Human Services (HHS) is evaluating whether to expand their current HPV vaccine recommendation to include this new age group. ACIP’s current recommendation is that boys and girls ages 9 through 15 should get two-doses of HPV-9. The “catch-up” vaccine schedule is a three- dose series for females above age 15 through age 27 and males above 15 years of age to 21 years of age, if not previously vaccinated with HPV vaccine. Should ACIP expand their recommendations for use of HPV-9 vaccine in the newly approved age group, the CDC won’t be alone in the push to increase the use of the HPV vaccine by children and adults in the U.S. During the September meeting of the National Vaccine Advisory Committee (NVAC), a federal advisory committee that makes recommendations to the National Vaccine Program Office (NVPO), the HHS Assistant Secretary ADM Brett Giroir M.D. emphasized that HHS supported the NVAC’s HPV vaccine recommendations published in June 2018. Dr. Giroir stated that increasing HPV vaccination in America would be a focus for HHS in 2019. The federal government’s focus on increasing the use recommendations for the HPV vaccine may result in a renewed effort by state legislators to introduce legislation in many states to mandate HPV vaccine for school entry.

BREAKING: FDA Sued as CDC Recommends Untested, Unlicensed Flu Vaccine for Pregnant Women

In response to a Freedom of Information Act (FOIA) lawsuit, the FDA has admitted, for the first time, that government agencies, including the CDC, are recommending vaccines for pregnant women that have neither been licensed for pregnant mothers by the FDA nor tested for safety in clinical trials. The lawsuit, filed by Children’s Health Defense (CHD) attorney, Robert F. Kennedy, Jr. on behalf of Informed Consent Action Network (ICAN), a vaccine safety advocacy group, sought all clinical trial data used by FDA to approve influenza vaccines for pregnant women. The FDA’s terse reply: “We have no records responsive to your requests.” Robert F. Kennedy, Jr. says, “As a nation, we can no longer pretend our trusted agencies are protecting our children. It is time to hold federal agencies accountable.”

Public Petitions FDA to Investigate Gardasil Vaccine Fraud

The following open letter to FDA Commissioner, Dr. Scott Gottlieb, calling for immediate investigations into many facets of the clinical trials for Gardasil sponsored by Merck was emailed today. Dear Dr. Gottlieb: This open letter, written on behalf of medical consumers around the world, is an urgent request for you to investigate potential malfeasance perpetrated by Merck during their clinical trials of Gardasil, the human papillomavirus vaccine that the FDA approved in June 2006. A new book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, by Holland, Rosenberg, and Iorio, outlines at least four areas requiring the FDA’s urgent attention.

FDA Decision to Approve Gardasil Vaccine for Adults Will Likely Increase Cervical Cancer Rates

The HPV vaccine was just approved for adults, despite Merck’s concerning research data. The FDA made its determination in the face of substantial evidence of the dangers of the HPV vaccine and the existence of safer alternatives. For women who have already been exposed to certain strains of the HPV virus, vaccination can actually increase the risk of precancerous lesions by 44.6%. That’s right: if you are already infected with HPV, getting vaccinated could increase your risk of getting cancer. To put this in perspective, 79 million Americans are thought to be infected with HPV, and about 14 million are newly infected each year, making HPV the most common sexually transmitted infection. Often there are no symptoms. The CDC says that “HPV is so common that almost every person who is sexually active will get HPV at some time in their life.” A large, government-backed push to get more people vaccinated for HPV could actually increase many people’s risk of getting cancer.

FDA Approves Experimental Hepatitis B Vaccine for Adults Despite Higher Incidence of Heart Attacks

In February 2018, the FDA and CDC approved the recommendation for a new hepatitis B vaccine, Heplisav-B targeting adults over the age of 18. The U.S. Food and Drug Administration (FDA) had twice rejected the application for licensure for Heplisav-B in the past four years because of safety signals. Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules. In 2016, the FDA rejected an application for licensure for the Heplisav-B vaccine, because the agency was concerned about an increased rate of heart attacks and deaths in people who had been given the vaccine. During the trial, approximately 14 subjects had heart attacks. In July 2017, the FDA committee convened to re-evaluate the scientific evidence and make a decision on whether Heplisav B should or should not be approved for use in the U.S. This committee had only one cardiologist on the team, Milton Packer, MD, who is a distinguished scholar in cardiovascular science at the Baylor University Medical Center in Dallas, Texas. According to Dr. Packer, it was possible that the Heplisav B vaccine’s novel adjuvant was related to the higher number of heart attacks in study participants who received the experimental vaccine. He stated: "To know if the 7 -1 heart attack imbalance represented a real risk, we’d need comparative data in 50,000 people." However, the only way to conduct such a large trial would be to approve the vaccine and see what happens in the public. With Dr. Packer abstaining in his vote to recommend the vaccine, the FDA committee approved it anyway. Dr. Packer stated: "Why did I abstain? Based on the available data, it was impossible for anyone to know if the increase in heart attack risk was real. There is a simple rule in life: if you don’t know, you should say you don’t know." The vaccine is now available to the public, and all those who receive it are basically guinea pigs to find out if heart attacks will result from the experimental vaccine, and if it will continue to have FDA approval.

The U.S. Needs an Independent Vaccine Safety Organization Separate from the Corrupt FDA and CDC

Most Americans are oblivious to the huge annual burden of chronic illness, injuries and deaths linked to vaccines. Some of the blame for the public’s ignorance belongs to a complicit media that “pretends that vaccine-related injuries do not occur.” However, the lion’s share of culpability for the buried story likely rests with the two federal agencies charged with vaccine oversight—the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC)—both of which regularly engage in various forms of deception to uphold their bland narrative that vaccines are unambiguously safe. One of the most significant criticisms has to do with the FDA’s and CDC’s business-as-usual reliance on external experts with financial ties to the pharmaceutical companies and/or products that they are evaluating. Little has changed since a congressional Committee on Government Reform outlined this problem nearly two decades ago. The Reform Committee examined the doings of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC), which determines whether new vaccines should be licensed, and the CDC’s Advisory Committee on Immunization Practices (ACIP), which recommends vaccines for inclusion in the childhood vaccine schedule. The congressional committee noted that FDA and CDC advisory committee members and chairpersons own stock in the vaccine companies under consideration, as well as own vaccine patents. The CDC “grants conflict of interest waivers to every member of their advisory committee a year at a time and allows full participation in the discussions leading up to a vote by every member,” even if a member has a financial stake in the decision.

FDA Has Acknowledged That Vaccine Technology is Outpacing Ability to Predict Adverse Events

Recently, top-tier autoimmunity researchers described vaccine safety science as a “hazardous occupation.” In their view, this is because uncompromising vaccine proponents are instantly ready to mount vociferous personal attacks on anyone who raises questions about any aspect of vaccine safety, even if the questions are buttressed by impeccable, high-quality science. Vaccine safety was not always such a taboo topic. In 1961, a leading polio researcher put forth the view in Science that “even after licensing, a new vaccine product must be considered to be on trial” because of the many “new variables” that accompany large-scale vaccine production and rollout. A leading Food and Drug Administration (FDA) official contended in 1999 that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a 'black box' vaccine referring to a situation of unforeseen and unpredictable vaccine outcomes.” Dr. Patriarca also voiced concerns that with live attenuated vaccines “there is the potential for these vaccines, many of which have been poorly characterized, to recombine with viruses that may be present in the vaccine. Some of these viruses are latent and persist for a while, so it is very important to assure that these things are safe before they are given to people.” In the two decades since the FDA official’s prescient words of warning, numerous published studies have highlighted vaccine safety concerns that were either unexplored or neglected prior to the introduction of the vaccines in question.

Is the European Medical Agency Experimenting on Babies with the Meningitis Vaccine Only Approved for Age 10 and Above?

In 2016, we published an article on the dangers of the meningitis B vaccination, Bexsero, titled, Are Ineffective New Meningitis B Vaccines Causing Harm to Children? At the time of publication, according to the FDA product information leaflet, the vaccine had in fact only been approved for children over the age of ten. Despite this fact however, in the UK, the meningitis B vaccine Bexsero is being administered to infants as young as 2 months, despite the fact that we could find no evidence to support that this vaccine was safe to be administered to babies. It has been brought to our attention that there are in fact two product information leaflets on the same vaccination. However, what is different about the second product information leaflet, published on January 14, 2015, by the European Medical Agency (EMA) is that the information that it provides, is the polar opposite, of the information provided by the FDA. Is the UK government conducting clinical trials on infants, and if they are, then are parents aware of this fact?