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.
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.
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.
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.
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?
By Dr. Mercola
The National Institutes of Health (NIH) is actually the second-highest funding source for drug studies (first is the drug companies, themselves). Many […]
by Vera Sharav
Alliance for Human Research Protection
This is an introduction to our lengthy IV-Part, fully referenced, review of America’s Healthcare Crisis—including numerous recent peer reviewed journal articles.
America’s acute […]