FDA News /fda FDA News Fri, 13 Jan 2017 23:18:18 +0000 en-US hourly 1 http://wordpress.org/?v=4.2.2 Vaccine pushers who promote mercury injections into children are “medical child molesters,” warns heavy metals expert /fda/2017-01-13-vaccine-pushers-mercury-injections-into-children-medical-child-molesters-warns-heavy-metals-expert.html /fda/2017-01-13-vaccine-pushers-mercury-injections-into-children-medical-child-molesters-warns-heavy-metals-expert.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-13-vaccine-pushers-mercury-injections-into-children-medical-child-molesters-warns-heavy-metals-expert.html On top of all the sicko pedophilia and child trafficking going on in America, there’s also the vaccine industry: A cartel of toxic mercury pushers whose denial of the periodic table of elements (yes, they are science deniers) turns them into “medical child molesters” as they demand more and more children be injected with toxic mercury, a known neurotoxin and potent heavy metal that causes brain damage.

As any genuine scientist or chemist knows, there is no such thing as a safe quantity or safe form of mercury for injecting into children. The continued advocacy of vaccines containing mercury — which continue to be pushed onto children and pregnant women all across America — is a crime against children and a gross violation of the American Medical Association’s code of medical ethics. (RELATED: Read more news about modern medicine’s ethical failures at Medicine.news)

As the lab science director of an internationally accredited heavy metals laboratory — CWClabs.com — I’ve personally tested vaccines for their mercury content, and I know more about heavy metals than most vaccine pushers will ever learn in their lives. (I wrote an Amazon.com #1 Science book on heavy metals in food called Food Forensics.) The simple truth is that mercury is a potent neurotoxin and it’s still being deliberately used in vaccines injected into infants, children and pregnant women all across America.

Mercury in vaccines is “chemical violence” against children

That’s a “chemical assault” and a form of violence against children. That’s why I’ve decided to start calling it “medical child molestation.” Hear my podcast below for more discussion. This means that medical hacks and vaccine propagandists like Dr. David Gorski and Calif. state Sen. Richard Pan are openly advocating a form of medical violence against children. Meanwhile, people like myself (the Health Ranger) are routinely vilified in the pharma-controlled media for practicing good science and working to protect children from a known neurotoxin. (Coming soon: News on Thimerosal at Thimerosal.news)

“There is no debate that mercury in any form is toxic. Scientists may debate the differences in toxicity between different forms of mercury, such as ethylmercury (which is an ingredient in Thimerosal) or methylmercury (from fish). But all would agree that mercury is a potent neurotoxin.” – Mark Hyman, M.D.

“The continued use of mercury, a known neurotoxin, raises particular concern for populations that are most vulnerable to neurodevelopmental harms, mainly a fetus in utero, infants, young children and the aged. When we speak of the health and safety of our children, our future generation, we speak of a societal responsibility, which we are privileged to bear… Many of the CDC’s own studies have demonstrated a link between increased Thimerosal exposures and the development of vocal and motor tics, which are generally recognized as autismlike features. This alarming association has been downplayed to the public.” — US Congressman Bill Posey

“That mercury is toxic cannot be disputed. To say otherwise is to pick a fight with the periodic table and the fundamental principles of physical chemistry. Consider the organization of electrons in atoms. Mercury is a large, heavy atom with more orbitals than lighter metals, like copper or zinc, and has a greater capacity to pick up and exchange electrons. …Mercury is thus a metabolic poison because it can insinuate itself into situations where it doesn’t belong.” – Martha R. Herbert, PhD, MD

“There is a broad consensus among research scientists that Thimerosal is a dangerous neurotoxin that should be immediately removed from medicines. Several hundred peer-reviewed scientific publications by the world’s leading research scientists, public health agencies, universities, and teaching hospitals have confirmed that Thimerosal is a potent neurotoxin that has never been proven safe for medical use and for which cost-effective alternatives exist.” – Robert F. Kennedy, Jr. from his book Thimerosal – Let the Science Speak: The Evidence Supporting the Immediate Removal of Mercury – a Known Neurotoxin – from Vaccines.

Listen to my full podcast on Thimerosal, vaccines and the “medical child molesters” who push them

Hear the full podcast at my Health Ranger Report website, or listen below, and be sure to check Vaccines.news daily for more breaking news about vaccines.

 

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This announcement by Donald Trump is going to make Big Pharma go berserk (podcast) /fda/2017-01-12-announcement-donald-trump-big-pharma-go-berserk-podcast.html /fda/2017-01-12-announcement-donald-trump-big-pharma-go-berserk-podcast.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-12-announcement-donald-trump-big-pharma-go-berserk-podcast.html In case you haven’t heard the great news, President-elect Donald Trump is already taking aim at Big Pharma’s obscene profits. He’s announced his intention to make them (finally!) engage in competitive bidding to supply prescription medications to the federal government, which purchases over $320 billion a year in prescription drugs. (Yep, almost a third of a trillion dollars each year…)

On top of that, Donald Trump has also launched a new investigatory commission to look into dangerous vaccine ingredients like Thimerosal (made from the toxic heavy metal mercury, which causes neurological damage).

Isn’t it amazing that in eight years of being President, Barack Obama never tried to protect children from mercury in vaccines?

And he never even told drug companies they would have to stop price gouging the federal government, either.

Yet even before he’s sworn in as President, Donald Trump is already accomplishing more than Obama ever dared imagine. We can’t wait to see what Trump can accomplish over the next eight years. (Stay informed on all of Trump’s accomplishments at Trump.news)

Listen to my Health Ranger Report podcast for more details:

 

 

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Important excerpts from Robert F Kennedy Jr’s book: Thimerosal – Let the Science Speak: The Evidence Supporting the Immediate Removal of Mercury – a Known Neurotoxin – from Vaccines /fda/2017-01-12-excerpts-from-robert-f-kennedy-jrs-book-thimerosal-let-the-science-speak-the-evidence-supporting-the-immediate-removal-of-mercury-a-known-neurotoxin-from-vaccines.html /fda/2017-01-12-excerpts-from-robert-f-kennedy-jrs-book-thimerosal-let-the-science-speak-the-evidence-supporting-the-immediate-removal-of-mercury-a-known-neurotoxin-from-vaccines.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-12-excerpts-from-robert-f-kennedy-jrs-book-thimerosal-let-the-science-speak-the-evidence-supporting-the-immediate-removal-of-mercury-a-known-neurotoxin-from-vaccines.html Robert F. Kennedy Jr. has just been selected by President-elect Trump to head a commission that will investigate the issue of “vaccine safety.” What this really means is that the era of mercury in vaccines may soon come to an end in America.

Donald Trump, as you may already know, is very well informed on the dangers of vaccines. In fact, during the very first presidential debate, the liberal media tried to destroy Donald Trump by claiming he was “anti-vaccine” (thereby implying that vaccines are always good and never cause harm).

Not only did Donald Trump respond by saying he personally knows people whose children were damaged by vaccines, but then Sen. Rand Paul and Ben Carson also chimed in and both agree that vaccines, as currently pushed by government, are far too dangerous.

What makes vaccines so dangerous? A toxic heavy metal known as mercury, for one thing. Astonishingly, it’s still used in flu shots given to pregnant women and young children.

Note: You can stay informed on vaccine issues with our daily news updates at Vaccines.news.

You need to get informed on this issue: It’s about to explode on the political scene

As an informed critical thinker, you need to get up to speed on the vaccine issue. One of the best books written on vaccine science was compiled and written by Robert F. Kennedy Jr. It’s called Thimerosal – Let the Science Speak: The Evidence Supporting the Immediate Removal of Mercury – a Known Neurotoxin – from Vaccines

Here, I present selected excerpts from the book, its foreward and executive summary sections. Read this, forward this and understand above all that no one in the lying mainstream media will ever report these crucial facts. The entire mainstream media is run by Big Pharma presstitutes who lie, deceive and propagandize for the benefit of the vaccine companies (drug manufacturers). They will never knowingly report the truth on this subject, no matter how many children are maimed or murdered by vaccines. (See many examples of fake news from the mainstream media at NewsFakes.com)

In addition to the excerpts below, I encourage you to read more from this book by buying it at BN.com (don’t buy from Amazon.com, as Amazon revenues subsidize the Washington Post, a discredit pro-vaccine propaganda mouthpiece for the corrupt state).

What follows is all from the book. I have personally selected the paragraphs to present here.

Foreward by US Congressman Bill Posey

(Excerpted from the book…)

Hundreds of parents from across the country have contacted me in recent years, describing their children as developing normally up to the time of receiving a particular vaccination.

In 2004 the Centers for Disease Control and Prevention (CDC) recommended that certain infants receive the annual flu vaccine—most of which contained Thimerosal. Over the next decade the CDC’s annual flu vaccine recommendations were expanded to include annual flu vaccines for infants, children, adults, and the aged.

The continued use of mercury, a known neurotoxin, raises particular concern for populations that are most vulnerable to neurodevelopmental harms, mainly a fetus in utero, infants, young children and the aged. When we speak of the health and safety of our children, our future generation, we speak of a societal responsibility, which we are privileged to bear.

During the writing of this book, I was approached by a CDC researcher who felt personally led to expose instances of research misconduct within the CDC, particularly with regard to a 2004 Pediatrics article, Age at First Measles-Mumps-Rubella Vaccination in Children With Autism and School-matched Control Subjects: A Population-Based Study in Metropolitan Atlanta. As this book discloses, this is not the first instance of CDC conduct to come under scrutiny. Regrettably, studies on the relationship between vaccines and autism have been subject to misconduct including data manipulation and false reporting.

Many of the CDC’s own studies have demonstrated a link between increased Thimerosal exposures and the development of vocal and motor tics, which are generally recognized as autismlike features. This alarming association has been downplayed to the public. Sadly, public health agencies’ insistence on Thimerosal’s safety has effectively inhibited objective investigations into research misconduct and conflicts of interest within health agencies and the vaccine industry.

– US Congressman Bill Posey

From Mark Hyman MD

(Excerpted from the book)

There is no debate that mercury in any form is toxic. Scientists may debate the differences in toxicity between different forms of mercury, such as ethylmercury (which is an ingredient in Thimerosal) or methylmercury (from fish). But all would agree that mercury is a potent neurotoxin.

The arguments put forth that we cannot remove Thimerosal from vaccines are invalid. Thimerosal has already been removed from nearly all vaccines except the multidose flu vaccine in the United States. This was based on government recommendations and a call to action from many agencies and health organizations, as is well documented in this book.

However, Thimerosal still remains in nearly all the pediatric vaccines used in the developing world. There are effective alternative preservatives already in use (2-phenoxyethanol), and new ones can be developed. The Food and Drug Administration (FDA) banned mercury as a topical antiseptic (remember Mercurochrome?). And any medical products containing Thimerosal or mercury cannot be thrown in the garbage. The Environmental Protection Agency (EPA) considers them hazardous waste. Does it make any sense that even though Thimerosal is not safe to put on your skin, or to throw in the garbage, it is safe to inject into pregnant women and babies?

We should practice the precautionary principle in medicine and avoid doing harm whenever possible. And given the simple fact that mercury is toxic, I can come to no other conclusion than this: we should immediately remove Thimerosal from vaccines and all other products used in medicine.

– Mark Hyman, MD

From Martha R. Herbert, PhD, MD

(Excerpted from the book)

This book advocates one specific step to improve vaccines: removing a known neurotoxin (mercury, in the form of Thimerosal) from the list of ingredients. To make a strong case for taking this step, the book presents voluminous evidence of:

  • The toxicity of Thimerosal
  • Its ineffectiveness even in the bactericidal role it is supposed to play
  • Safer alternatives to Thimerosal that are already available
  • A history of the calls of scientists and high-level governmental and international agencies around the world to remove Thimerosal entirely from vaccines
  • Implementation of this course of action in some other countries

It argues that removing Thimerosal entirely will improve both vaccines themselves and people’s trust in them.

That mercury is toxic cannot be disputed. To say otherwise is to pick a fight with the periodic table and the fundamental principles of physical chemistry. Consider the organization of electrons in atoms. Mercury is a large, heavy atom with more orbitals than lighter metals, like copper or zinc, and has a greater capacity to pick up and exchange electrons. The specific ways it can do this are not as tightly determined as in lighter atoms, making it a biochemical “wild card.” Mercury is thus a metabolic poison because it can insinuate itself into situations where it doesn’t belong. In particular it can substitute itself for lighter metals like zinc and selenium around which critical ancient enzyme systems are designed. This grossly cripples the specificity of enzymes and rates of reaction, and can spread chaos in the networks of metabolic processes, which try to generate workarounds to this logjam—but at great cost to biological and energetic resources, and often without success. This chaos may disrupt development as well as ongoing function throughout life.

Moreover, while claims have been made that the ethylmercury in Thimerosal is safer than the much better-studied methylmercury, these claims are based on weak, questionable evidence and poorly chosen assumptions. As reviewed in Chapters 4-6 herein, available data suggests that the toxicity of these two forms of mercury is at least comparable, and that ethylmercury may leave the blood more quickly—only to persist more stubbornly in organs and tissues of the body, particularly the brain.

Furthermore, mercury’s toxicity can be even worse in the presence of aluminum, which is also an ingredient in many vaccines and has toxicity issues of its own (Chapter 11).

This all being the case, why are we still putting mercury in vaccines—or in any medical product (roughly 169 consumer products including eyedrops and nose drops still contain Thimerosal)—and how can we bring ourselves to stop doing this?

When it comes to mercury, not only is it clearly toxic, even at very low exposures… but our bodies derive no physiological benefit from it whatsoever. Nevertheless, one out of six children in the United States is born with levels of mercury high enough to be put at risk for neurological complications like learning disabilities, motor skill impairments, and short-term memory loss.

We can be exposed to mercury by eating fish (particularly those predators high on the food chain), being downwind of coal-fired power plants and other coal-fired industrial processes such as cement kilns, being near mines, being downwind of trash incinerators that burn hazardous and medical waste, breaking mercury-containing devices such as older thermometers, and having dental amalgams. People, including infants and pregnant mothers, can also be exposed to mercury through vaccines. In the United States, this exposure comes mainly from influenza vaccines. Although Thimerosal was removed from mandatory childhood vaccines in the United States, cumulative exposure is still high due to regular Thimerosal-containing flu shot administration starting in pregnancy and infancy.

To take mercury out of vaccines is a different matter. It is used as a preservative in multidose vials, even though it doesn’t actually do that job so well (Chapter 10), and we have safe and effective alternatives (Chapter 12). Companies making vaccines could either change the preservative or shift to single-dose vials, which actually will not increase societal costs as much as has been claimed…

…By exposing the population to unnecessary mercury in vaccines, we are gambling with population health through the same intervention that we use to protect it.

it is clear now that mercury is something to which no one should be deliberately exposed. As such, it is an error to include it in vaccines or indeed in any therapeutics—and in these domains it is an error within our grasp to correct, and prudent to do so. We tend to take a long time to correct errors—it took seventy-five years to get the lead out of gasoline. Let’s do a better job this time. So many considerations and pieces of evidence are compiled in this one comprehensive volume. I hope and implore that it moves us all to do whatever it takes—make whatever adjustments necessary—to correct this error, because it CAN be corrected—indeed MUST be corrected—so let’s just DO IT. THEN we can focus more effectively on the harder problems lying ahead.

– Martha R. Herbert, PhD, MD

From RFK, Jr.:

People who advocate for safer vaccines should not be marginalized or denounced as anti-vaccine. I am pro-vaccine. I had all six of my children vaccinated. I believe that vaccines have saved the lives of hundreds of millions of humans over the past century and that broad vaccine coverage is critical to public health. But I want our vaccines to be as safe as possible.

…There is a broad consensus among research scientists that Thimerosal is a dangerous neurotoxin that should be immediately removed from medicines. Several hundred peer-reviewed scientific publications by the world’s leading research scientists, public health agencies, universities, and teaching hospitals have confirmed that Thimerosal is a potent neurotoxin that has never been proven safe for medical use and for which cost-effective alternatives exist.

Indeed, the evidence of Thimerosal’s neurotoxicity is so overwhelming and the lack of any safety data so complete that anyone who is willing to read science and who believes in the capacity for scientific methods to determine empirical truths must conclude that Thimerosal causes serious brain damage.

For many years, I’ve been puzzled by the bland and apparently baseless insistence by public health regulators and members of the press that it is safe to inject mercury—one of the world’s most neurotoxic elements—into young children and pregnant women. Over the past three years, I’ve engaged a crack team of respected scientific researchers to review the voluminous peer-reviewed literature related to Thimerosal and human health. Not surprisingly, that team was unable to find even a single publication that credibly demonstrates Thimerosal’s safety. Meanwhile, reams of toxicological, pharmacological, epidemiological, animal, and human studies have implicated Thimerosal in a range of neurological disorders. In fact, there is a virtually unanimous scientific consensus among the hundreds of research scientists who have published peer-reviewed articles in the field that Thimerosal is immensely toxic to brain tissue and should not be injected into children.

Public health agencies and government officials have repeatedly declared Thimerosal-preserved vaccines to be safe. Among the most important examples of these statements is a widely known report from the Institute of Medicine (IOM) published in 2004. The report purported to refute any link between Thimerosal exposure and autism. However, this conclusion was based almost entirely on epidemiological studies, which are unable to prove causation. Furthermore, the epidemiological studies have many flaws, and their authors possess significant conflicts of interest.

Exposure to Thimerosal increased beginning in 1989 and rose sharply during the early 1990s as new vaccines were added to the US childhood vaccine schedule. This increased exposure to mercury via vaccines coincided closely with increased case reports of neurodevelopmental disorders, including a dramatic increase in autism spectrum disorder (ASD) cases and a rise in attention deficit hyperactivity disorder (ADHD).16 17 According to various studies, the prevalence of ASDs rose in the US from a historical rate of approximately 1 in 2,000 through the 1980s to as high as 1 in 166 children by the early 2000s.1819 Attention problems reported by pediatricians’ offices rose from 1.4 percent of patients in 1979 to 9.2 percent by 1996, according to one study, with other studies also documenting a steady upward movement in rates of ADD and ADHD from 1970s’ baselines.

Although Thimerosal now only appears in trace amounts in vaccines on the US childhood immunization schedule, the potential threat to children’s neurological health continues today in the form of seasonal flu vaccines, preserved with Thimerosal, that are administered to pregnant women and babies.

Recent CDC figures confirm ADHD prevalence has remained as high as nearly 1 in 10 children.28 29 The prevalence of any developmental disability in US children went up from 12.84 percent in 1996 to 15.04 percent by 2008.30 ASD statistical rates, for their part, have soared higher still. In March 2012, the reported prevalence (as of 2008, in 8 year olds) stood at 1 in 88 children; in March 2013, the prevalence figure (as of 2011-2012, between the ages of 6 and 17 years) came in at a staggering 1 in 50 children, with 1 in 31 boys affected, though this report was based on a less-reliable survey of parents. Most recently, in March 2014, a more reliable figure of 1 in 68 was reported (as of 2010, in 8 year olds).

Based on this book’s analysis, we are calling for policy and industry shifts that will lead to Thimerosal’s removal from all remaining vaccines within a year. Vaccines are unquestionably one of the greatest achievements in medical science. They have prevented countless terrible illnesses. We hope that the elimination of an unnecessary mercury-containing ingredient in vaccines will ease future doubts about vaccine safety. Restoring faith in the vaccine regimen while maintaining or increasing vaccination rates is critical in the United States and especially in developing nations, where Thimerosal-containing childhood vaccines are still very much in use.

Get the book and keep reading… you’ll be amazed

Read more by buying the book at BN.com (don’t buy from Amazon.com, as Amazon revenues subsidize the Washington Post, a pro-vaccine fake news rag run by deceptive globalists).

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New quietly approved rule allows companies like McDonald’s to sponsor and advertise in national parks /fda/2017-01-12-new-quietly-approved-rule-allows-companies-like-mcdonalds-to-sponser-and-advertise-in-national-parks.html /fda/2017-01-12-new-quietly-approved-rule-allows-companies-like-mcdonalds-to-sponser-and-advertise-in-national-parks.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-12-new-quietly-approved-rule-allows-companies-like-mcdonalds-to-sponser-and-advertise-in-national-parks.html When seeking an escape from the bustle of daily life and the marketing messages that bombard us everywhere we go. from our kids’ TV shows to the local grocery store, many of us head to the great outdoors. Out in nature with an abundance of fresh air and clean water, and surrounded by plenty of greenery, we relish the chance to unwind and unplug.

If your idea of “getting away from it all” entails visiting a national park, however, you might soon find that it is less of an escape from corporate America than it once was. While you were busy enjoying the holidays with your family and friends, a controversial set of rules was quietly granted approval that will allow advertisements to intrude on the parks’ natural beauty.

Order lifts ban on ads in national parks

The new order signed by National Park Service Director Jonathan B. Jarvis on December 28, puts an end to the ban on commercial advertising in national parks and removes restrictions on naming rights. The order, which is known as Order #21 on Donations and Philanthropic Partnerships, expands commercial contracts with private firms and corporate sponsorships. (RELATED: Read more examples of total stupidity at Stupid.news)

The National Park Service controls 412 parks, monuments, recreational areas and battlefields that together cover 84 million acres of land, which means an influx of new marketing opportunities will be opened up to corporate sponsors. The National Park Service recently said it was launching a fundraising campaign to the tune of $350 million; the federal budget set aside nearly $3 billion for the agency in 2016.

Public outcry

More than 200,000 people have signed a petition against the controversial move. Kristen Strader, the coordinator of the advocacy group, Public Citizen, who organized a campaign against these proposed reforms, said the move was “disgraceful.” In addition to the petition, hundreds of individuals have lodged official objections with the National Park Service.

Public Citizen joined forces with the Campaign for a Commercial-Free Childhood to publish public comments on the proposal after the Parks Service failed to do so. They say that 78 percent of commenters were opposed to the policy.

“Now that this policy has been finalized, park visitors soon could be greeted with various forms of advertisements, like a sign reading ‘brought to you by McDonald’s’ within a new visitor’s center at Yosemite, or ‘Budweiser’ in script on a park bench at Acadia,” Strader said.

The park service is now trying to allay people’s fears by implying that the public does not fully understand the order. While it will allow donors to be recognized by the parks with labels on some items, corporations and other types of sponsors will not be allowed to rename parks. They also point out that logos and ad language will not be allowed. They liken these provisions to those found in hospitals, museums and universities whereby certain rooms might be temporarily renamed in recognition of a donor that supported renovations, for example. The NPS director must approve of all signage.

Despite these assurances, opponents insist that the move is opening up our national parks to a previously unseen amount of commercial influence, and many fear this is only the beginning. This approach embodies much of what is wrong with America these days. Commercialization already reaches us everywhere we go, and the value of nature is being increasingly marginalized in favor of the all-important bottom line. Whether it’s the push by Big Pharma to make people think their toxic prescriptions are superior to the healing plants provided by the earth, or the ongoing global deforestation to clear land for other money-making endeavors, governments around the world are turning a blind eye to corporate tactics that destroy our planet’s natural resources and beauty.

Sources include:

CommonDreams.org

FoxNews.com

Consumerist.com

AJC.com

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Trial to begin for pharmacist whose contaminated medications made hundreds deathly ill /fda/2017-01-11-trial-to-begin-for-pharmacist-whose-contaminated-medications-made-hundreds-deathly-ill.html /fda/2017-01-11-trial-to-begin-for-pharmacist-whose-contaminated-medications-made-hundreds-deathly-ill.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-11-trial-to-begin-for-pharmacist-whose-contaminated-medications-made-hundreds-deathly-ill.html On January 9th, 2017, lawyers made their opening statements in the murder trial of pharmacist Barry Cadden, owner of New England Compounding Center. CNN reports that the compounding pharmacy sold contaminated vials of the steroid methylprednisolone acetate that in 2012 were injected into the spinal columns of more than 13,000 patients. Subsequently 751 people were diagnosed with various infections, including fungal meningitis. Sixty-four patients died, in the worst outbreak of meningitis in US history. Meningitis is a grave condition where the membranes that surround the brain and spinal cord become inflamed.

Cadden could spend his life in prison if convicted on all 25 counts of second-degree murder. Glenn A. Chin, NECC’s supervisory pharmacist, will also face 25 counts of second-degree murder at a later trial. According to CNN, Cadden’s 2014 indictment indicates that the government does not need to prove intent, but rather that the pharmacists acted with “extreme indifference to human life.” The indictment also includes charges of racketeering, aiding and abetting, conspiracy, and mail fraud. The indictment claims that safety regulations such as cleaning and sterilization were flaunted by NECC and that its pharmacists lied about it. The indictment also alleges that Cadden used expired materials and failed to properly sterilize drugs. (RELATED: Stay informed about pharmaceutical medicine at Medicine.news)

What is compounding?

According to the website of the Professional Compounding Centers of America, “Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.”

A long history of misdeeds

CNN further notes that the Massachusetts Department of Public Health reported in 2012 that it had “identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health at risk.”

But NECC has come under scrutiny long before this final tragedy. Quoting from the Modern Medicine website, “[The] FDA had issued a warning letter, dated Dec. 4, 2006, to NECC for its various practices deviating from traditional compounding of drugs that are not available commercially. In its letter to Barry Cadden, director of pharmacy and owner of NECC, FDA notified him that NECC had several violations that had to be corrected or the agency had the right to ‘seizure and injunction against you and your firm.'”

The website states that the FDA was particularly concerned about how NECC would open a sterile container of liquid medication and split it into multiple doses of single-use vials that lacked any preservative. On an October 2012 episode of NPR’s Diane Rehm Show, David Miller, the executive vice president of the International Academy of Compounding Pharmacists, condemned NECC for profiting to the tune of millions of dollars while functioning as a drug manufacturer, and not as a compounding pharmacy. Miller explained that NECC prepared mass quantities of drugs back in 2006, and did not make small batches for single patients. On the Rehm Show, Miller also made the point that the FDA visited the pharmacy multiple times in the span of a decade, issued a warning, and yet despite the red flags, did not shut them down.

Nowhere to turn

Federal regulatory agencies like the FDA are supposed to protect the public from this kind of wrongdoing, yet in this instance, dozens of innocent victims paid with their lives. With the revolving door between Big Pharma and the FDA, and with the fantastical but true direct funding of the FDA by the pharmaceutical industry, we clearly we have a case of the ‘fox guarding the hen house.’ How safe do you feel?

Sources:

CNN.com

PccaRx.com

ModernMedicine.com

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Draining the Pharma swamp: Donald Trump announces plan to hammer Big Pharma’s monopoly profits by requiring competitive bidding for government drug purchase contracts /fda/2017-01-11-donald-trump-announces-plan-to-attack-big-pharma-monopoly-profits-by-requiring-competitive-bidding-government-drug-purchases.html /fda/2017-01-11-donald-trump-announces-plan-to-attack-big-pharma-monopoly-profits-by-requiring-competitive-bidding-government-drug-purchases.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-11-donald-trump-announces-plan-to-attack-big-pharma-monopoly-profits-by-requiring-competitive-bidding-government-drug-purchases.html In a welcome announcement during a press conference today, President-elect Donald Trump announced a plan to shatter the monopolistic pricing of Big Pharma that has been draining literally trillions of dollars from the government for the past two decades.

“Pharma has a lot of lobbyists and a lot of power,” said Trump. “There’s very little bidding on drugs. We’re the largest drug buyer in the world, and we’re going to start bidding. We’re going to start saving billions of dollars on drugs.” (RELATED: See more coverage of President Trump at Trump.news)

Trump is referencing the fact that all the former Presidents in recent memory — Clinton, Bush and Obama — have maintained what can only be called a “monopoly pricing drug cartel” in the United States, where the U.S. government pays outrageously high prices for prescription medications purchased via Medicare, federal health coverage plans and VA Hospital operations. The utter lack of competitive pricing has been kept in place by an army of pharma lobbyists “bribing” complicit lawmakers and bureaucrats to keep high prices in place and eliminate competitive bidding for prescription medication purchase contracts. (RELATED: See daily coverage of medicine news at Medicine.news)

$324.6 billion a year in overpriced prescription medications to appease Big Pharma lobbyists

As a result, the federal government is spending hundreds of billions of dollars on overpriced prescription drugs each year, dolling out a whopping $324.6 billion on prescription drugs in 2015 alone. “Spending on prescription drugs outpaced all other services in 2015,” says a Centers for Medicare and Medicaid report entitled National Health Expenditures: 2015 Highlights.

That same report reveals that U.S. health care spending has now reached $3.2 trillion annually, or nearly $10,000 per person. If this spending isn’t curtailed, it’s going to bankrupt America and will soon hit an astonishing 25% of GDP, meaning 1 out of every 4 dollars generated in the entire U.S. economy will be going to drug companies, cancer treatment centers, hospitals, doctors and medical device manufacturers.

High drug prices weaken U.S. worker competitiveness in global marketplace

Obviously, that rate of expenditure is unsustainable. It also makes U.S. workers far more expensive than workers in overseas regions, harming the economic competitiveness of U.S. companies. In order for U.S. workers to remain competitive, U.S. health care costs need to be drastically reduced… and that means finally forcing drug companies to compete on pricing rather than receiving “full retail” monopoly-priced reimbursements from the federal government.

Making America Great Again, in other words, means stopping the federal government from being ripped off by Big Pharma.

Notably, Hillary Clinton’s campaign accepted millions of dollars from Big Pharma sources, and there’s little question that Clinton, if she had won the election, would have maintained the status quo of monopoly prices. See “Hillary Clinton will not challenge FDA Monopoly” and “If you support Hillary Clinton, you support big pharma and mandatory vaccinations.” (RELATED: Find more news on Hillary Clinton at Clinton.news)

In contrast, Donald Trump is genuinely “draining the swamp” by eliminating waste, fraud and abuse across many sectors of the federal government. Big Pharma just got served: The era of easy profits and a compliant federal government writing unlimited fat checks is now coming to an end.

Every American fed up with unaffordable drug prices, outrageous health insurance premiums and the corruption and influence of lobbyists in Washington D.C. should applaud this announcement by Trump.

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Experts Reveal What FDA and Big Pharma Hid from US Public (Video) /fda/2017-01-11-experts-reveal-what-fda-and-big-pharma-hid-from-us-public-video.html /fda/2017-01-11-experts-reveal-what-fda-and-big-pharma-hid-from-us-public-video.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-11-experts-reveal-what-fda-and-big-pharma-hid-from-us-public-video.html Experts reveal what the FDA and Big Pharma have been hiding from the US public:

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15 Things You Eat That Are a Lie (Video) /fda/2017-01-11-15-things-you-eat-that-are-a-lie-video.html /fda/2017-01-11-15-things-you-eat-that-are-a-lie-video.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-11-15-things-you-eat-that-are-a-lie-video.html Here are 15 things you eat that are a lie:

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What’s killing Americans? Top 10 prescribed medications of 2016 give us a troublesome answer /fda/2017-01-11-whats-killing-americans-top-10-prescribed-medications-of-2016-give-us-a-troublesome-answer.html /fda/2017-01-11-whats-killing-americans-top-10-prescribed-medications-of-2016-give-us-a-troublesome-answer.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-11-whats-killing-americans-top-10-prescribed-medications-of-2016-give-us-a-troublesome-answer.html ‘Let food be thy medicine’ is a saying attributed to Hippocrates, who is known as the Father of Modern Medicine. We would be well off to heed his advice, but by and large, we do not, for it is the Standard American Diet that is making us sick. A look at the most often prescribed medications reveals the most common health conditions we are being treated for. And these conditions reveal a problem with our diet, because our poor health is closely correlated with our poor food choices.

Our food supply has been adulterated by heavy processing, it’s laden with chemical additives and pesticides, and it lacks the all-important mineral content, due to poor quality soil, after years of high-intensity agricultural practices. Is it any wonder that we are one of the sickest nations in the developed world?

You are what you eat

This truism is all too true, for if we eat healthy foods, we will be healthy. But if we eat unhealthy foods, we will be unhealthy. Here is a list of the top ten prescriptions in America in 2016 (from LowestMed.com), along with the associated health condition, the dietary culprit, and a healthier dietary approach.

1. Atorvastatin Calcium is prescribed for high cholesterol. The most recent research bucks conventional wisdom and attributes high cholesterol to refined carbohydrates, not fats. Substituting high quality fats and oils for the empty carbs is the solution.

2. Levothyroxine is used to treat hypothyroidism, or an underactive thyroid. Fluoride in our food and water is absorbed by the body in place of iodine. Iodine is woefully deficient in most people and is essential for healthy hormone production by the thyroid gland. Try to avoid ubiquitous fluoride and supplement iodine.

3. Lisinopril is used for high blood pressure, which is associated with heart attacks. Too much salt is blamed for high blood pressure, but low magnesium is most often overlooked.

4. Omeprazole treats reflux symptoms, which medical orthodoxy says is caused by too much stomach acid, whereas it is likely caused by too little production of hydrochloric acid. Make sure you get enough sodium chloride, or table salt in your diet.

5. Metformin is used to lower blood sugar for diabetes patients. Many physicians now blame a diet rich in refined carbohydrates for the onset of type 2 diabetes, and believe that it can be controlled solely through diet.

6. Amlodipine is used to treat hypertension.

7. Simvastatin treats high cholesterol.

8. Hydrocodone/Acetamenophen treats pain; not necessarily related to diet.

9. Metoprolol ER is prescribed for hypertension.

10. Losartan is prescribed for hypertension.

The low fat fallacy

Obesity is linked as a causative factor to diabetes, cancer, and cardiovascular disease, all major contributors to mortality. Regarding our dietary habits, the standard advice in favor of a low fat diet is probably what is killing us. Dr. Atkins puts it this way:

“In recent years, research has indicated that we may have been doing it all wrong. To verify that, just ask yourself: If low-fat diets work, why are we so fat? Sure, you could blame some of it on people with weak willpower, or metabolic problems, or whatever. But when nearly two-thirds of the nation is overweight, those excuses just don’t hold water.

“There is now an enormous body of research that proves that the conventional wisdom about the role fats play in the human diet is, quite simply, wrong, and in fact, it’s a high-carb, high-fat diet that results in weight problems and all the diseases that go along with being overweight. Culprits include the USDA Food Triangle, which guides school lunch programs across the country–it’s top-heavy on refined grains, including pasta and other starches while limiting foods containing fats. And many foods that are thought of as healthy–such as bran muffins, fruit juices and most brands of diet shakes and nutrition bars–are loaded with empty calories and high carbohydrate counts.”

Where do we go from here?

Many natural and non-toxic alternatives are available in the form of foods, supplements, and herbs for the above listed maladies. All prescription medications are toxic to an extent, some with serious health consequences. Most medical doctors have very little nutritional training, if any. Many doctors will straight up tell you that nutrition does not affect disease conditions. Are the insane running the asylum?

Sources:
WakingTimes.com

Atkins.com

LowestMed.com

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FDA admits cybersecurity vulnerabilities in pacemakers, insulin pumps and MRI systems /fda/2017-01-09-fda-admits-cybersecurity-vulnerabilities-in-pacemakers-insulin-pumps-and-mri-systems.html /fda/2017-01-09-fda-admits-cybersecurity-vulnerabilities-in-pacemakers-insulin-pumps-and-mri-systems.html#respond Wed, 30 Nov -0001 00:00:00 +0000 http://162.244.66.231/fda/2017-01-09-fda-admits-cybersecurity-vulnerabilities-in-pacemakers-insulin-pumps-and-mri-systems.html People who use various medical devices, such as pacemakers, insulin pumps and MRI systems, already have enough to be concerned with just in terms of dealing with their medical conditions. But on top of that, now they also need to deal with the issue of cybersecurity vulnerabilities that affect these devices and that have been admitted by the FDA.

FDA acknowledges that medical devices are at risk

Not just the computer systems of large corporations, governments and financial organizations are vulnerable to cybersecurity threats. The FDA is now admitting that medical devices, and in turn the patients who use them, could be victims of hacking. “Cybersecurity threats are real, ever-present and continuously changing,” admitted Suzanne Schwartz, a senior Food and Drug Administration official. “And as hackers become more sophisticated, these cybersecurity risks will evolve.” Unlike hacks that involve other computers and are mere inconveniences in the big picture, threats that involve medical devices are potentially life-threatening, such as in the case of certain heart devices. This is certainly not what any patient who uses a device like this or their loved ones wants to hear.

How the FDA has attempted to address the risks

In light of these security risks, it is clear that the FDA needs to develop rules and policies that will help to identify these vulnerabilities and then address them, with the goal of reducing the threats to these devices that many patients rely on. The FDA has taken some actions in recent years to try to do that:

  • It published a 30-day document providing guidance on cybersecurity issues.
  • In 2014, it published a document explaining how medical device manufacturers need to deal with cybersecurity threats when they are developing various new products. This did not address products that were already being sold at the time the document was published.
  • In 2015, it told hospitals to stop using a particular infusion pump made by Hospira Inc. because a security risk could open the door for hackers to control the device from a distance

The FDA will need to stay on top of this issue and do as much as possible, because there has been mounting evidence in recent years that these threats and bugs in medical devices are real. In addition, the issues of cybersecurity risks and hacking seem to worsen over time.

What manufacturers need to do

Manufacturers of medical devices that could potentially be affected by cybersecurity threats should be extremely vigilant as well. They need to determine which products that are already on the market are at risk for threats and then determine a way to remedy the situation. If threats are severe enough to require such severe action, they need to remove products from the market that have risks so severe that they cannot be remedied. They also need to develop new products with cybersecurity threats at the forefront of their minds by designing products to be more insulated from cybersecurity threats. With all their products, they need to have ways for security experts to quickly and efficiently report potential cybersecurity threats. Finally, they need to openly communicate with medical organizations, patients and the FDA regarding any information about cybersecurity threats.

Technology can lead to many medical advances but often also brings down sides such as cybersecurity threats. Patients who use medical devices that could be affected by cybersecurity threats should stay well informed and educated about what to do. Find out if the devices you use are vulnerable to cybersecurity threats. Discuss the issue of cybersecurity threats with the doctor who prescribed the device, and ask them for advice.

Sources:

Reuters.com

ManagedCareMag.com

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