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Vaccine Makers And FDA Regulators Used Statistical Gimmicks To Hide Risks Of HPV Vaccines – New Study

(Natural Blaze By Robert F. Kennedy, Jr.) A new study published in Clinical Rheumatology exposes how vaccine manufacturers used phony placebos in clinical trials to conceal a wide range of devastating risks associated with HPV vaccines. Instead of using genuine inert placebos and comparing health impacts over a number of years, as is required for most new drug approvals, Merck and GlaxoSmithKline spiked their placebos with a neurotoxic aluminum adjuvant and cut observation periods to a matter of months.

Researchers from Mexico’s National Institute of Cardiology pored over 28 studies published through January 2017—16 randomized trials and 12 post-marketing case series—pertaining to the three human papillomavirus (HPV) vaccines currently on the market globally. In their July 2017 peer-reviewed report, the authors, Manuel Martínez-Lavin and Luis Amezcua-Guerra, uncovered evidence of numerous adverse events, including life-threatening injuries, permanent disabilities, hospitalizations and deaths, reported after vaccination with GlaxoSmithKline’s bivalent Cervarix vaccine and Merck’s quadrivalent or nine-valent HPV vaccines (Gardasil and Gardasil 9). Pharmaceutical company scientists routinely dismissed, minimized or concealed those injuries using statistical gimmicks and invalid comparisons designed to diminish their relative significance.

Scientific researchers view double-blind placebo trials as the gold standard for testing new drugs. To minimize bias, investigators randomly assign patients to either a “treatment” group or a “control” (placebo) group and then compare health outcomes. The standard practice is to compare a new drug against a “pharmacologically inert” placebo. To minimize opportunities for bias, neither patients nor researchers know which individuals received the drug and which the placebo. However, in clinical trials of the various HPV vaccines, pharmaceutical researchers avoided this kind of rigor and instead employed sleight-of-hand flimflams to mask the seriousness of vaccine injuries.

Related: The MMR Vaccine – A Comprehensive Overview of the Potential Dangers and Effectiveness

Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison. One does not have to be a scientist to understand that using aluminum-containing placebos is likely to muddy the comparison between the treatment and control groups. Critics of the HPV vaccine have pointed to the aluminum adjuvant as the most likely cause of adverse reactions, and some researchers have questioned the safety of using aluminum adjuvants in vaccines at all, due to their probable role as a contributor to chronic illness. The aluminum-containing placebos appeared to provoke numerous adverse reactions among the presumably unwitting patients who received them, allowing the pharma researchers to mask the cascade of similar adverse reactions among the groups that received the vaccines. Although both placebo and study groups suffered numerous adverse events in these studies, there were minimal differences between the two groups. The similar adverse outcomes in both groups allowed industry researchers and government regulators to claim that the vaccines were perfectly safe, despite manifold disturbing reactions. The Mexican researchers’ meta-review confirms the difficulty of ascertaining vaccine-attributable differences from this mess; the researchers identified only a few indications of “significantly increased systemic adverse events in the HPV vaccine group vs. the control group” across the 16 pre-licensure trials.

The HPV promoters found it more difficult to employ deceptive devices in the 12 post-marketing safety reviews, and the Mexican authors summarize some of the more noteworthy findings. In Spain, they found a ten-fold higher incidence of vaccine-related adverse events following HPV vaccination compared to “other types of vaccines.” In Canada, they found an astonishing one in ten rate of hospital emergency department visits among HPV-vaccinated individuals “within 42 days after immunization.” Still, the industry researchers did what they could to minimize these injuries. The Mexican reviewers criticize the authors of the various post-marketing studies for failing to ask essential questions, to evaluate the many serious adverse events, or to elaborate on their often-troubling findings.

Abbreviated Trial Times

Typically, FDA requires drug companies seeking approval for a new drug to observe health outcomes in both the placebo and study groups for 4-5 years. Vaccine manufacturers take advantage of FDA regulatory loopholes that allow fast-tracking of vaccines and cut that period down to a few weeks or even a few days. This means that injuries that manifest, or are diagnosed, later in life—most neurodevelopmental disorders, for example—will escape attention entirely.

Related: How To Detoxify and Heal From Vaccinations – For Adults and Children

Further Smokescreens

Martínez-Lavin and Amezcua-Guerra point to clinical trial data posted on the FDA webpage for the quadrivalent Gardasil vaccine approved in 2006. Those clinical trials deployed a panoply of the kind of cunning deceptions used by industry and government researchers. Unlike many of the other HPV vaccine clinical trials, these clinical studies employed a true saline placebo.

Across the Gardasil clinical studies, a group of 15,706 females ages 9-45 and males ages 9-26 received the quadrivalent Gardasil vaccine. A control group of 594 individuals received an inert saline placebo. The industry researchers never explain the tiny relative size of the saline placebo group; it’s noteworthy that small size would have the effect of keeping unwanted signals weak. But a second control group of 13,023 received a so-called “spiked” placebo loaded with an aluminum adjuvant (amorphous aluminum hydroxyphosphate sulfate or AAHS). The large size of this “spiked placebo” group suggests that the decision to keep the saline placebo group small was strategic.

Putting aside the thorny ethical question of whether study participants were told that they were being injected with a neurotoxin with probable associations with Alzheimer’s, dementia and other forms of brain disease, the inclusion of both saline and aluminum placebos provided these researchers a chance to do some genuine science. But the FDA webpage shows the troubling gimmick that was then employed by the FDA and Merck, which seems deliberately designed to blur datasets in order to mask adverse effects during the clinical trials. The table showing relatively minor injection-site adverse reactions—one to five days post-vaccination—displays three distinct columns for the three groups: Gardasil recipients, the aluminum “placebo” recipients, and saline placebo recipients (see table below). In the table, “Intergroup differences are obvious,” in the words of the Mexican researchers. For example, roughly three and a half times more girls/women experienced injection site swelling in the Gardasil group compared to the saline group (25.4% vs. 7.3%). In fact, by all five measures, both the Gardasil recipients and the aluminum placebo recipients fared two to three times worse than the saline recipients.When it came time for Merck to report on the occurrence of more serious reactions, “Systemic Adverse Reactions” and “Systemic Autoimmune Disorders,” for example, the company scientists switched to a very different format. In these tables, the third column that reported results for the saline placebo recipients disappears. Instead, Merck combined the groups receiving the spiked aluminum placebo into a single column with the group receiving the genuine saline placebo (see example below). The merger of the two control groups makes it impossible to compare results for Gardasil versus the saline placebo or the aluminum placebo versus the saline placebo. In this way, Merck’s researchers obliterated any hope of creating a meaningful safety comparison.

Risks and Benefits

Given aluminum’s known neurotoxicity and its association with debilitating autoimmune conditions, it is unsurprising that there are no observable differences between the Gardasil and AAHS/saline groups. But, despite the researchers’ efforts to paper over adverse effects, they were not able to conceal the devastating health injuries to their human guinea pigs. The bottom line of these trials reveals a shocking truth: An alarming 2.3% of both their study and control groups had indicators of autoimmune diseases! These data are even more alarming when one considers that the observation period was curtailed after only six months. With this level of risk, it would seem that no loving parents would allow their daughter to receive this vaccine—particularly given the comparatively low risk posed by HPV in countries with appropriate cervical cancer screening tests. Even in countries such as India, where cervical cancer mortality is high due to late detection, leading Indian physicians argue that comprehensive screening should be the country’s top priority rather than the “panacea” of HPV vaccination.

Related: Reasons Not To Vaccinate

Consider the math: According to the National Institutes of Health (NIH), an estimated 2.4 women per 100,000 die of cervical cancer in the US each year. On the other hand, the FDA’s Table 2 (above) shows that 2.3 per 100 girls and women developed an “incident condition potentially indicative of a systemic autoimmune disorder” after enrolling in the Gardasil clinical trial. It is difficult to understand how any rational regulator could allow more than two in 100 girls to run the risk of acquiring a lifelong autoimmune disorder, particularly when Pap smears are already doing an effective job of identifying cervical abnormalities. The NIH notes that the incidence and death rates for cervical cancer in the US declined by more than 60% after introducing Pap smear screening.

Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Martínez-Lavin and Amezcua-Guerra make their own effort to illustrate the zany risk-benefit ratios associated with these vaccines when discussing the results of one of the 16 clinical trials. That study compared approximately 14,000 women who received either Gardasil 9 or the original quadrivalent Gardasil. Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Implications for Aluminum Adjuvants

Merck found that astronomical casualty counts were equal among both Gardasil and aluminum “placebo” recipients. The inescapable implication is that aluminum adjuvants may be a principal culprit in the flood of injuries reported for the various HPV vaccines. This conclusion, if true, requires reevaluation of the use of aluminum adjuvants in several other vaccines, including some given to infants. Aluminum adjuvant levels have mushroomed since the 2003 removal of thimerosal from three pediatric vaccines. The following chart, prepared by Dr. Sherri Tenpenny, illustrates the stunning amount of aluminum in vaccines.

Related: Autism, Gut Health, Obesity, the MMR Vaccine, and Andrew Wakefield

Multiple peer-reviewed studies have connected aluminum exposures to a range of autoimmune and neurological disorders, including dementia and Alzheimer’s disease, that have become epidemic coterminous with these aluminum exposures. A review in the European Journal of Clinical Nutrition warns of dangerous accumulation of aluminum in the brain when, as in the case of vaccination, “protective gastrointestinal mechanisms are bypassed.” It’s time to go back to the drawing board on HPV vaccines and aluminum adjuvants. More importantly, FDA needs to start requiring the same rigorous pre-licensing safety testing for vaccines that it has long required for other drugs. All existing vaccines, particularly those containing aluminum, should be safety-reviewed according to these more stringent standards.

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This article appeared first at World Mercury Project and appears on Natural Blaze with permission.

Pesticides Can Block Colony Formation In Bumblebees, Could Lead To Extinction: Study

(Natural Blaze By Jason Erickson) Regular readers of Natural Blaze are probably well aware of the threat that neonics present to the ecosystem. For this reason, it is essential that we continue to focus on each new study that reinforces what the alternative media seems willing to cover, but the mainstream not so much.

The plight of the pollinator continues to be documented by studies linking neonicotinoid pesticides to a range of negative effects upon bees and their colonies. Neonics have been implicated in tens of millions of bees instantly dropping dead at a single honey farm after nearby spraying of GMO crops. One type of neonic has even been shown to negatively affect social behavior within the hive itself, causing bees to abandon their responsibilities with protective care and foraging.

The issue is exacerbated by major producers of these pesticides who have been implicated in false advertising, self-funded studies, and covering up their own negative test results, thus making it difficult for the public at large to become fully informed about the severity of what is taking place.

Related: The Difference Between Heirlooms, Hybrids, and GMOs

While an increasing number of countries, particularly in Europe, have become properly aware and have taken action against neonicotinoids, the U.S. stubbornly clings to their widespread use. This is happening even as the bumblebee has been put on the endangered species list in the U.S. for the first time.

A new study adds to a developing concern that aside from the aftereffects of neonics upon living bees, they are also fundamentally restricting breeding patterns and colony formation. Researchers are sounding the alarm that if protective measures are not taken, this logically could lead to a full extinction of the bumblebee.

Related: Understanding and Detoxifying Genetically Modified Foods

Many people remain unaware that neonicotinoids are a family of pesticides, each of which carries its own negative consequences. Thiamethoxam is one of them that is being scrutinized. Professor Nigel Raine from the University of Guelph has been instrumental in establishing that this particular neonic threatens breeding patterns. The first study, which we covered back in May, concluded that:

…neonicotinoid pesticides hinder wild queen bumblebee’s reproductive success.

Raine says if queens need to use energy to clear pesticides from their system instead of investing in eggs, there will be fewer fully developed eggs. “This will likely translate into slower egg-laying rates, which will then impede colony development and growth.”

In the newest study from Raine, et al., which appeared in Nature Ecology and Evolution, what was previously suspected is sadly being confirmed and fully quantified, with a minimum of 25% reduction of colony formation.

Bumblebees are less able to start colonies when exposed to a common neonicotinoid pesticide, according to a new University of Guelph study.

Prof. Nigel Raine has discovered that exposure to thiamethoxam reduces the chances of a bumblebee queen starting a new colony by more than a quarter.

“Bumblebee queens that were exposed to the neonicotinoid were 26 per cent less likely to lay eggs to start a colony,” said Raine, holder of the Rebanks Family Chair in Pollinator Conservation. “A reduction this big in the ability of queens to start new colonies significantly increases the chances that wild populations could go extinct.”

Source

Related: Permaculture Agriculture – The Transition to a Sustainable Future

One has to wonder how much more evidence needs to be acquired for regulatory agencies across the world to speed up efforts to eradicate these toxins from the ecosystem. We certainly look forward to the day when this becomes a topic that we no longer need to cover.

Jason Erickson writes for NaturalBlaze.com. This article (Pesticides Can Block Colony Formation in Bumblebees, Could Lead to Extinction: Study) may be republished in part or in full with author attribution and source link.

New ‘Monsanto Papers’ Add To Questions Of Regulatory Collusion, Scientific Mischief

(U.S. Right to Knowby Carey Gillam) Four months after the publication of a batch of internal Monsanto Co. documents stirred international controversy, a new trove of company records was released early Tuesday, providing fresh fuel for a heated global debate over whether or not the agricultural chemical giant suppressed information about the potential dangers of its Roundup herbicide and relied on U.S. regulators for help.

More than 75 documents, including intriguing text messages and discussions about payments to scientists, were posted for public viewing early Tuesday morning by attorneys who are suing Monsanto on behalf of people alleging Roundup caused them or their family members to become ill with non-Hodgkin lymphoma, a type of blood cancer. The attorneys posted the documents, which total more than 700 pages, on the websitefor the law firm Baum Hedlund Aristei Goldman, one of many firms representing thousands of plaintiffs who are pursuing claims against Monsanto. More than 100 of those lawsuits have been consolidated in multidistrict litigation in federal court in San Francisco, while other similar lawsuits are pending in state courts in Missouri, Delaware, Arizona and elsewhere. The documents, which were obtained through court-ordered discovery in the litigation, are also available as part of a long list of Roundup court case documents compiled by the consumer group I work for, U.S. Right to Know.

It was important to release the documents now because they not only pertain to the ongoing litigation, but also to larger issues of public health and safety, while shedding light on corporate influence over regulatory bodies, according to Baum Hedlund attorneys Brent Wisner and Pedram Esfandiary.

“This is a look behind the curtain,” said Wisner. “These show that Monsanto has deliberately been stopping studies that look bad for them, ghostwriting literature and engaging in a whole host of corporate malfeasance. They (Monsanto) have been telling everybody that these products are safe because regulators have said they are safe, but it turns out that Monsanto has been in bed with U.S. regulators while misleading European regulators.”

Esfandiary said public dissemination of the documents is important because regulatory agencies cannot properly protect public and environmental health without having accurate, comprehensive, and impartial scientific data, and the documents show that has not been the case with Monsanto’s Roundup herbicide and the active ingredient glyphosate.

Monsanto did not respond to a request for comment.

Several of the documents discuss a lack of robust testing of formulated Roundup products. In one email, Monsanto scientist Donna Farmer writes “you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient.”

The release of the documents Tuesday came without the blessing of Judge Vince Chhabria, who is overseeing the multidistrict litigation moving its way through the U.S. District Court for the Northern District of California. In March, Chhabria did agree to unseal several other discovery documents – over Monsanto’s objections – and those documents prompted a wave of outrage for what they revealed: questionable research practices by Monsanto, cozy ties to a top official within the U.S. Environmental Protection Agency, and indications that Monsanto may have engaged in “ghostwriting,” of research studies that appeared to be independent of the company.

The revelations within those documents prompted an investigation by the EPA’s Office of Inspector General into possible Monsanto-EPA collusion, and roiled Europe where regulators now are trying to decide whether or not to reauthorize glyphosate, which is the most widely used herbicide in the world and is found in numerous products in addition to Roundup.

The lawyers said they are sending copies of the documents to European authorities, to the EPA’s OIG and to the California Office of Environmental Health Hazard Assessment (OEHHA), which has been sued by Monsanto for moving to list glyphosate as a known carcinogen

Monsanto has fought to keep most of the documents it turned over in discovery sealed, complaining to Judge Chhabria that in several court filings plaintiffs’ attorneys presented discovery materials out of context and tried to exploit the information to influence public opinion. Chhabria has both chided Monsanto for trying to improperly seal certain documents and warned plaintiffs’ attorneys against unfairly publicizing certain documents. It is unclear how Judge Chhabria will react, if at all, to the law firm’s release of these documents.

Baum Hedlund attorneys said they notified Monsanto on June 30 of their intent to unveil the 86 documents and gave Monsanto the legally required 30-day window to formally object. That period expired Monday, clearing the way for them to make the release early Tuesday, said Wisner.

Concerns about the safety of glyphosate and Roundup have been growing for years amid mounting research showing links to cancer or other diseases. But the lawsuits only began to accumulate after the International Agency for Research on Cancer (IARC) in 2015 classified glyphosate as a probable human carcinogen. The plaintiffs in the lawsuits allege that the combination of glyphosate with certain surfactants used in Monsanto-branded Roundup products is even more toxic than glyphosate alone, and Monsanto has sought to cover up that information.

Monsanto has publicly denied that there are cancer connections to glyphosate or Roundup and says 40 years of research and scrutiny by regulatory agencies around the world confirm its safety.

Monsanto has made billions of dollars a year for decades from its glyphosate-based herbicides, and they are the linchpin to billions of dollars more it makes each year from the genetically engineered glyphosate-tolerant crops it markets. The company is currently moving toward a planned merger with Bayer AG.

Damning Investigation Shows Big Pharma Bribed 68,000 Doctors To Push Deadly Opioids

(Natural Blaze by Claire Bernish) More than 68,000 doctors received payments in excess of $46 million — in the span of just 29 months — from Goliath pharmaceutical corporations pushing opioid painkillers, researchers in a groundbreaking investigation of Big Pharma’s and the epidemic of legal and illicit opiates plaguing the United States.

Money to push opioids found one doctor in 12, and the rampant destruction wrought upon countless American families forced to cope with loved ones dependent on prescription painkillers, or on heroin sought when those ran out, proves circumstantially the dollars did their job.

“The next step is to understand these links between payments, prescribing practices, and overdose deaths,” Scott Hadland, a pediatrician and author of the study, published in the American Journal of Public Health, told the Washington Post.

Averaged out, more than 1,000 people suffered fatal drug overdoses per week in 2015, the Centers for Disease Control and Prevention reported, and steep spike occurred during the first six months of the following year — which the National Centers for Health Statistics attributes largely to a sharp rise opioid deaths — in particular, heroin and the potent synthetic painkiller, fentanyl.

Despite heroin driving that abrupt increase, Hadland points out that, for many,

It’s very common that the first opioid they’re ever exposed to is from a prescription.

Indisputably, the opioid crisis presents a quagmire of issues, each seeming to perpetuate others; and while its complexities seem monumental, the twin agitators of pharmaceutical money to physicians to push dangerous painkillers and the multifarious war on drugs — especially federal prohibition of cannabis, which helps alleviate dependency — present the simplest avenues to explore solutions.

To wit, Boston Medical Center researchers found the largest sums were given to doctors to push fentanyl — a painkiller anywhere from 50 to 100 times stronger than morphine, used for the extreme pain of cancer, end of life, and more. Illicit fentanyl manufactured overseas is cut into heroin — when can overwhelm the user’s system with a lethal cocktail of opioids and synthetics.

Drug developers engineered tamper-proof fentanyl pills in response to the epidemic, but the study found pharmaceutical companies, on the whole, were not aggressively marketing those safer versions to doctors.

According to the investigation, the top 1 percent of physicians, around 700, received 82.5 percent of total sum of payments for opioids. Speaking fees constituted approximately two-thirds of the total dollars Big Pharma bestowed to physicians, but pharmaceutical reps wined and dined doctors more than any other courting activity, constituting just under 94 percent of total payouts.

Incidentally, the analysis of public data from Centers for Medicare and Medicaid Services revealed, Big Pharma opioid money inundated every corner of the U.S.; but, Indiana, Ohio, and New Jersey — the three states bearing the harrowing brunt of the nationwide opioid scourge — recorded the largest number of payments to doctors.

That this study is believed the first of its kind — coupled with its focus on pharmaceutical opioid cash — speaks to the influence those millions upon millions each year tragically outscream the mourning throngs of families whose loved ones originally sought only to alleviate untenable pain.

Corporate media and pharmaceutical marketers have muddied potential solutions in proposals to solve the nation’s pill problem with yet more pills — or their equivalent — legalization of cannabis, found to treat opiate addiction, would do more to extricate opioid addicts from their potentially fatal substance dependency than nearly any other option.

Study authors conclude, “These findings should prompt an examination of industry influences on opioid prescribing” — a study the mounting scores of dead attest should have been undertaken years ago.

Claire Bernish began writing as an independent, investigative journalist in 2015, with works published and republished around the world. Not one to hold back, Claire’s particular areas of interest include U.S. foreign policy, analysis of international affairs, and everything pertaining to transparency and thwarting censorship. To keep up with the latest uncensored news, follow her on Facebook or Twitter: @Subversive_Pen. This article first appeared at The Free Thought Project.

Dementia Now the Top Cause of Death Among Women in the UK

(Natural News) A recent report by the Public Health England revealed that Alzheimer’s disease and dementia are now the leading causes of death among women in the United Kingdom. According to the report, the country’s overall life expectancy for women has shown a significant increase in years, which is now 83.1 years. However, these added years are characterized by poor health. As per the report, women are expected to live about a quarter of their lives being ill.

The report also noted that while other diseases exhibited a relative decline, the rates of Alzheimer’s disease and dementia have doubled since 2001. In fact, the cognitive diseases were accounted for 15.3 percent of deaths among British women.

Related: Beat Alzheimer’s Disease Naturally

“These figures once again call attention to the uncomfortable reality that currently, no one survives a diagnosis of dementia. Dementia is not an inevitable part of ageing, it’s caused by diseases that can be fought through research, and we must bring all our efforts to bear on what is now our greatest medical challenge,” Alzheimer’s Research U.K. official Hilary Evans told BBC.com.

Are vaccines to blame for the increasing rates of dementia?

Exposure to heavy metals — such as mercury and aluminum — by way of vaccines and medicines have long been associated with an increased risk of developing dementia and other neurological conditions. In fact, an analysis published in the Journal of Alzheimer’s Disease revealed that long-term mercury exposure was linked to the onset of Alzheimer’s disease symptoms including confusion, impaired memory, and cognitive function decline. Mercury was mostly used as a preservative in many childhood vaccines until 2001.

Related: The Alzheimer’s Aluminum Connection

On the other hand, a study published in 2009 revealed that aluminum, another heavy metal commonly added to flu shots, may raise the odds of developing dementia and other neurological conditions. According to the study, people who had the highest aluminum content in their drinking water had the highest risk of suffering from the condition. A vast number of clinical studies have also shown that the heavy metal was directly tied to the onset of brain damage. (Related: Aluminum in vaccines linked to Alzheimer’s and other neurological conditions.)

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