Aging Is Officially A Disease

Aging Is Officially A Disease
Source: GreenMedInfo.com
Jennie Ann Freiman M.D.
May 15, 2017

The search for eternal life isn’t new, but how far we’ve come from the Holy Grail, the Fountain of Youth and the hidden valley of Shangri-La, is truly a sign of the times. Today, the crossroads meet between the natural tendency to find an easy way out, and the seductive promise of profits. The quest is on for how to put longevity in a pill. 

Classifying age as a disease means insurance companies will cover treatment.  The FDA just paved the way.

Two years ago, investigators convinced the FDA to green-light a human lifespan study of Metformin, a drug currently used as first-line treatment for blood sugar control in type 2 diabetes, and off-label for polycystic ovary syndrome, weight control, and cancer prevention. If successful, Metformin will be the first drug to be FDA-approved for the indication of aging, but it won’t be the last. With a potential audience of 7½ billion people worldwide, pharmaceutical companies will race to fund clinical trials for the discovery of new, more expensive drugs.

High levels of blood sugar and insulin are important factors in degenerative disorders, cardiovascular disease, cancer, and aging. Metformin lowers blood sugar in two ways, by using it efficiently and preventing its production in the liver. This, in turn, lowers insulin levels and insulin resistance. The drug intrigues researchers because its protective effect on aging goes beyond the power to control sugar and insulin.

Everything Metformin can and might do for healthy aging can be achieved with lifestyle choices.

The TAME Study (Targeting Aging With Metformin) began in 2016, aiming to enroll 3,000 seniors, ages 70 – 80, and study them for 5 – 7 years at 15 centers across the U.S. Study subjects can have or be at risk for any or all of 3 common aging conditions: cancer, heart disease, and dementia. The study excludes type 2 diabetics because the effect of Metformin has already been shown in that group. The question is whether Metformin can delay or prevent cancer, heart disease, cognitive impairment, diabetes and death in non-diabetics. If it does, the obvious next step is to test it for use in much younger people.

Clues about Metformin’s role in anti-aging come from studies of fruit flies, roundworms, and mice. Most of the credit goes to an enzyme few people have heard of, AMPK (adenosine monophosphate-activated protein kinase). AMPK regulates how cells process energy, which, when working well, helps prevent all of the chronic diseases associated with aging, and aging itself. The goal is to activate AMPK to gain its benefits and live a healthier, longer life.

AMPK Benefits For Healthspan And Lifespan:

  • Increases metabolism
  • Burns fat and sugar / Weight loss
  • Improves body composition
  • Increases blood flow
  • Antioxidant
  • Anti-inflammatory
  • Cell detoxification and renewal

Is Metformin the anti-aging miracle drug researchers hope for, or will it go the way of some other FDA “miracles” before it? Fen-Phen Vioxx, Meridia, Baycol, and DES, are just a few that come to mind.

There is good reason for skepticism:

  • Aging is a chronic, inflammatory process that leads to a loss of structure and function, impairing both healthspan and lifespan. Aging is best addressed with health and longevity promoting strategies, not disease prevention.
  • Aging is multifactorial. Elements that benefit or harm longevity work together in synergy. The magic bullet approach, focusing on one aspect of disease, works for simple problems like treating a strep throat with penicillin, but disappoints for complex chronic disorders and aging. It has failed over and over, but investigators refuse to let it go.
  • Every drug has side effects and risks that must be weighed against its benefits. Metformin carries a black box warning for the rare, but real, risk of developing lactic acidosis, a potentially fatal build-up of lactate in the blood, especially for anyone with reduced kidney function. More common side effects are nausea, vomiting, diarrhea, headache and drowsiness. Let’s don’t forget the “inactive ingredients” that act as toxic counterweights to any drug benefits:

FORTAMET® Extended-Release Tablets.  In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: candelilla wax, cellulose acetate, hypromellose, magnesium stearate, polyethylene glycols (PEG 400, PEG 8000), polysorbate 80, povidone, sodium lauryl sulfate, synthetic black iron oxides, titanium dioxide, and triacetin.

  • Metformin may promote Alzheimer’s Disease. Type 2 diabetes is a risk factor for Alzheimer’s, so researchers assume drugs that treat diabetes will prevent dementia. Unfortunately, studies link long-term Metformin use to a greater risk of developing AD and worsening its progression. One study proposed this occurs because the drug increases production of beta-amyloid, a protein universally recognized as a hallmark of Alzheimer’s.
  • Studies suggest Metformin may accelerate existing cancer and cancer-related mortality by promoting AMPK-induced cellular uptake of glucose, which effectively feeds the tumors cells.
  • Aspirin, a more widely used drug than Metformin, also activates AMPK and may be a safer choice if going the drug route. Metformin is pro-inflammatory.

Generally, when something sounds too good to be true, it is. Activating AMPK promotes longevity, but isolating one strategy from the context in which it normally occurs, is like a game of Jenga: disrupt the delicate balance and the whole thing falls apart.

There is a better way.

Natural anti-aging approaches exist and have been scientifically validated.  They take commitment and they’re not easy but they avoid the inevitable downside of chronic drug use.  They activate AMPK and all of its interrelated systems.

  • Calorie restriction is the most successful method of slowing and reversing markers of aging. The idea is to lower calorie intake a moderate amount to induce a healthy level of stress that strengthens cells and organ, but not so much as to cause malnutrition. The ongoing CALERIE study is monitoring healthy individuals committed to a 25% reduction in caloric intake. So far, results are promising.
  • Intermittent fasting (also known as “time-restricted feeding”) is an alternative to calorie restriction. Confining eating to an 8 to 12-hour daily window reduces inflammation and free radical damage, and has been shown to fight dementia, cancer and promote longevity.
  • Exercise uses up energy, which activates AMPK. High intensity, short interval exertion is especially effective. Muscle contraction during both aerobics and weight training stimulates AMPK and increases insulin sensitivity.
  • Cold water immersion after exercise enhances AMPK and cellular renewal. Going from the sauna into the plunge pool, or taking an ice cold shower after a workout are easy ways to practice cold shock. It’s great training for the annual Polar Bear Challenge.
  • Healthy eating habits activate AMPK. Go for a well-rounded diet of unprocessed, highly colorful foods including:
  • Get good sleep. Impaired quality and/or quantity of sleep is incompatible with long-term health. For example, obstructive sleep apnea is related to a 20% reduction in life expectancy, weight gain, heart disease, diabetes, earlier than average age of onset of memory disorders and cognitive impairment. Melatonin, the sleep hormone, activates AMPK and cellular rejuvenation, protecting against cardiovascular and other sleep deprivation related disorders.
  • Acupuncture is effective in treating obesity and improving cognitive function. It upregulates AMPK in the hippocampus, the brain center for short term memory and ground zero for the development of Alzheimer’s Disease.

These and other natural anti-aging strategies are consistently practiced in Blue Zones, unrelated regions around the globe where the most long-lived people are found. Drugs and “longevity genes” are not the reason this Guinness World Record-worthy group boasts a large number of centenarians. Their way of life is the secret sauce for extending healthspan and lifespan.

Whatever your age, it’s never too late for a healthy system reboot. Start now, by adopting a lifestyle game plan that promotes healthy longevity.

Next stop, Methuselah.

Read More At: GreenMedInfo.com

REFERENCES:

black box warning: 

http://www.greenmedinfo.com/article/metformin-and-sulfonylurea-drugs-are-associated-adverse-side-effects-such-lactic-acidosis

cancer-related mortality:

http://www.greenmedinfo.com/article/patients-type-2-diabetes-who-use-sulfonylureas-or-insulin-have-increased-risk-cancer-related

pro-inflammatory:

http://www.greenmedinfo.com/article/even-short-term-treatment-metformin-causes-decrease-serum-cobalamin-folic-acid

Calorie restriction:

http://www.greenmedinfo.com/article/isocaloric-carbohydrate-restriction-diet-and-natural-ampk-activating-agents

Exercise:

http://www.greenmedinfo.com/blog/exercise-stops-mitochondrial-aging-process-its-tracks

Healthy eating habits:

http://www.greenmedinfo.com/article/polyphenols-may-have-therapeutic-value-variety-diseases-through-modulating-amp#!

Turmeric:

http://www.greenmedinfo.com/blog/how-turmeric-can-save-aging-brain-dementia-and-premature-death

Red wine:

http://www.greenmedinfo.com/article/present-review-discusses-potential-role-resveratrol-regulating-ampk-activity-bproinflamatory   

Melatonin, the sleep hormone:

http://www.greenmedinfo.com/article/melatonin-could-have-effect-body-weight

other natural anti-aging strategies:

http://www.greenmedinfo.com/article/lipoic-acid-may-have-therapeutic-value-obesity-postmenopausal-women

 

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.
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Study: Safety Issues Plagued 1/3 of FDA-Approved Drugs from 2001-2010 Even as President Trump pushes for quicker drug approvals

drugs
Source: NaturalSociety.com
Julie Fidler
May 19, 2017

The U.S. Food and Drug Administration (FDA) is tasked with making sure that drugs and medical devices are safe and efficient for Americans to use. However, it appears that the agency doesn’t take its job seriously enough, because a new study shows that nearly 1/3 of medications approved from 2001 to 2010 had safety issues years after they were made widely available to patients, and some were quite serious. [1]

The study, published May 9 in JAMAshows that 71 of the 222 drugs approved during that time period were withdrawn, required a “black box” due to their side effects, or warranted a safety announcement about new risks.

Source: Center for American Progress

Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, says:

“While the [Trump] administration pushes for less regulation and faster approvals, those decisions have consequences.”

A 2015 independent analysis of drugs approved using the agency’s expedited approval process found that the trend of speeding approval “is being driven by drugs that are not first in class and thus potentially are less innovative.” [2]

But President Trump isn’t the first president to pressure the FDA to speed up its drug approvals.

On December 13, 2016, President Barack Obama signed the 21st Century Cures Act. The law provides speedier routes to approval by pushing the FDA to consider evidence beyond the normal 3 phases of clinical trials. The move upset many researchers who feared the law would allow the approval of drugs that haven’t been adequately studied.

Says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University, who wasn’t involved in the study:

“I’m actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job. The one place you don’t want to cut a corner is safety and efficacy prior to coming to market.”

According to the study, during the first decade of the millennium, the FDA approved drugs faster than the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), the majority of clinical trials in drug approvals involved fewer than 1,000 participants, and lasted 6 months or less, according to the findings. [1]

On average, it took 4 years and 2 months after the drugs were approved for safety issues to emerge. The most troublesome drugs included psychiatric medications, biologic drugs, drugs granted “accelerated approval,” and drugs that gained approval at the tail end of the regulatory period.

But drugs that were granted accelerated approval had the worst track record. Dr. Nicholas S. Downing, an author of the study and a resident physician of internal medicine at Brigham and Women’s Hospital in Boston, says:

“The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug.

Downing says that scientists need to continuously test drugs to make sure they work with a wide range of variables, and used aspirin as an example. The medication has been used for hundreds of years, yet “there are still countless new studies coming out, and we learn more about it all the time.” [2]

Read More At: NaturalSociety.com

Sources:

[1] Kaiser Health News

[2] CNN

Center for American Progress

New Safety Concerns Identified For 1 in 3 FDA-Approved Drugs


Source: News.Yale.edu
Ziba Kashef
May 9, 2017

Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study. While most of the safety concerns are not serious enough to require withdrawal of a drug from the market, the finding highlights the need for ongoing surveillance of new drugs in the post-market period, said the researchers.

The findings were published May 9 in the Journal of the American Medical Association (JAMA).

To assess new drugs for safety and effectiveness, the FDA relies on premarket drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less, making it difficult to detect safety issues that might be identified once more patients use the drug over a longer time period. To identify factors that might enhance patient safety and regulatory surveillance efforts, the Yale-led team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017.

The research team, led by associate professor of medicine and public health Dr. Joseph Ross, found that 32% of new drugs were flagged for a safety issue after approval. “That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” said Ross.

The researchers also identified characteristics of drugs that were more likely to be associated with a safety concern, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway.

While the study results point to the need for ongoing monitoring of newly approved drugs, they also demonstrate that the FDA’s current process is working. “The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,” Ross noted.

At a time when the FDA is under pressure to accelerate drug approvals, the study findings provide key information about the agency’s process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. At the very least, the study should inform ongoing debate about premarket drug evaluation, the researchers said.

Other authors on the study are Nicholas Downing, Nilay Shah, Jenerius Aminawung, Alison Pease, Jean-David Zeitoun, and Harlan Krumholz. All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest, which are detailed in the study.

There was no funding for this research.

Read More At: News.Yale.edu

New Study: FDA-Approved Drugs Are Dangerous

FakeNews

Source: JonRappoport.wordpress.com
By: Jon Rappoport
May 11, 2017

It turns out every new medical drug should contain a warning: “The FDA approved this medicine. Watch out.”

Perhaps the warning should be more extreme: “If you’re taking this drug, have an emergency medical crew on stand-by.”

A new study, published in the Journal of American Medical Association, examined all 222 drugs approved by the FDA between 2001 and 2010. The finding? Years after approval, roughly a third of the medicines were then labeled with warnings about serious adverse effects; and some of those warnings indicated life-threatening complications. For example, cancer and liver damage. For example, death—which, the last time I looked, is life-threatening.

The Washington Post reports: “Among the drugs with added warnings [years after the drugs were approved, as safe, for public use]: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner. The withdrawn drugs [taken off the market] and the reason: Bextra, an anti-inflammatory medicine, heart problems; Raptiva, a psoriasis drug, rare nervous system illness; and Zelnorm, a bowel illness drug, heart problems.”

A pharma trade-group spokeswoman told the Post: “Even with rigorous clinical studies and regulatory review it may be impossible to detect certain safety signals until several years after approval, once the medicine is in broader use.”

No doubt. And that’s why the public is subjected to the luck of the draw, a roll of the dice, a spin of the roulette wheel.

Of course, as I never tire of pointing out, a landmark review (July 26, 2000) in the Journal of American Medical Association, by Dr. Barbara Starfield, found that, every year in the US, FDA approved drugs kill 106,000 people. Extrapolating to a decade, that would be a million deaths.

The new study confirms only a small part of the overall problem.

And the overall problem is what major media don’t want to report on—and what the federal government doesn’t want to touch with a 10-foot pole.

The new study is what intelligence agencies would call a limited hangout, which is a public admission of part of a problem or scandal that is, in fact, much bigger. The huge scandal, in this case, is the routine death-by-medicine numbers every year—which is ignored by the press and the government.

106,000 Americans killed by FDA approved medicines every year. That’s the big one. That remains hidden and unacknowledged.

NOTE: under Trump, the FDA is urged to speed up the drug-approval process. It’s good for business. For patients, it’s a disaster on top of the already existing disaster.

Read More At: JonRappoport.wordpress.com
_______________________________________________________________

Jon Rappoport

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

Risperdal: The Long & Winding Trail Of Crimes

FakeNews

Source:JonRappoport.wordpress.com
By: Jon Rappoport
May 9, 2017

PREFACE:

Readers have noticed I’ve been redoubling my efforts lately to expose medical crimes. This circus of madmen needs exposing.

Medical criminals are leeches on the public body. They will say and do anything to maintain their position of authority.

They will say their fantasies are fact. They will say their toxic drugs are cures. They will say their useless and fake diagnoses are real. They will, when they work for drug companies, claim their latest maybe-could-be-hope-so breakthrough innovation is right around the corner.

As they work on their victims, they will deny they are sucking the life blood out of them. They will say they are helping them.

And they will defend themselves as scientists.

This is my experience working as an INDEPENDENT reporter for 35 years.

This is my experience investigating the center-stage area of the medical system: the long-term treatment of illness that goes on and on, from one diagnosis to another, one toxic drug to another, as people are brought into the circus, as they are guided through the circus for their whole lives.

The whole circus is fake. It’s a delusion. It’s money. It’s profit. It’s control. It’s poisonous. It’s the rigor of the parasite feeding on its victim.

The way to get out of it is to get out of it.

Over the years, I’ve had the ambition and the determination to document these medical matters. I’ve found evidence by the truckload. I’ve approached readers from many different angles with that evidence. I continue to do so.

What keeps me going is my perception of the circus—that it is a presentation of reality, a whole-hog reality, invented from scratch, by fools and liars and pretenders and psychopathic criminals.

What keeps me going is the understanding that the other side is: revolt—which includes people creating their own reality, the reality they truly want.

These are unshakable things.

The leeches know they need us for their sustenance. They are trying to pass laws that will make it mandatory for us to line up and watch them work on us—new laws, more laws. More binding laws.

So freedom is the clarion call. Freedom dispels the delusions and exposes the fakers. Freedom means people choose how to deal with their own bodies and minds. Freedom is the silver bullet to the vampiric lunatics. Freedom is the imperative. And freedom never goes away, even for the most abject slave. It comes to him in his dreams.

Freedom is the essence. You look at it, you take it. You stand with it. You launch from it.

Mainstream medical reporters—the most entrenched ones—are a low breed. They defend the leeches. They rally the public, who, hypnotically and aggressively (knowing nothing) stand for “science.” This is the great joke in the middle of the circus. The great, cruel, enduring joke.

RISPERDAL:

The drug was approved, by the FDA, for public use in 1993, to treat schizophrenia, a “mental disorder” for which there is no defining diagnostic test. No blood test, no saliva test, no brain scan, no genetic assay.

In 2006, the FDA approved Risperdal to treat “irritability” in autistic children. There is no defining diagnostic test for autism. The neurological damage involved can come from any cause—especially vaccines. But of course, all public health agencies deny this fact.

In 2007, the FDA approved Risperdal to treat bipolar disorder in children between the ages of 10 and 17. Bipolar is another “mental disorder” for which there is no defining diagnostic test.

Risperdal was approved to treat three conditions, which are diagnosed by casually observing a patient’s behavior and comparing it to a menu of behaviors called schizophrenia, bipolar, and autism.

If the drug had no adverse effects, that would be one thing; but it has devastating effects. Tardive dyskinesia, a permanent “movement disorder” that signals brain damage. Suicide. Gynecomastia—boys grow female breasts.

Before I go on, NOTE: Rapid withdrawing from psychiatric drugs can have disastrous effects. See Dr. Peter Breggin on this subject.

Now let’s get to the lawsuits against Johnson & Johnson, Risperdal’s manufacturer:

2012: J&J fined $1.2 billion for hiding adverse effects of the drug. Decision overturned on appeal.

2012: J&J paid out $181 million for actively promoting off-label uses for Risperdal. Doctors are permitted to prescribe a drug for unapproved uses, but drug companies cannot legally promote or urge doctors to wander into that off-label territory.

2015-2016: There are at least 1500 suits against J&J for causing boys to grow female breasts. Thus far, three verdicts have been decided in favor of the boys, for $1.75 million, $2.5 million, and $70 million.

The story of Risperdal expands and explodes when we consider the marketing effort behind it. Basically, the hustle involved claims that the drug could be used to treat a wide array of so-called disorders in children.

I will now quote extensively from a classic article written at madinamerica.com, by Paula J Caplan, PhD. The title of her article (10/30/2015) is “Diagnosisgate: A Major Media Blackout Mystery”:

“Until their identities are widely exposed, and their motives are known, the full story of the [Risperdal] harm will never be known. It is astonishing that despite six stories in the major media — including a recent, groundbreaking Huffington Post series — and the filing of numerous lawsuits, the names and conduct of the culprits have consistently been omitted.”

“The story that has been called ‘Diagnosisgate’ starts in 1995, when the man widely considered the world’s most important psychiatrist split a payoff of nearly one million dollars with two colleagues in exchange for doing two patently unethical and illegal things that created the groundwork for a major drug company to market falsely one of the most dangerous psychoactive drugs [Risperdal].”

“Part one: In return for almost half a million dollars, they ignored what was known about the drug [Risperdal] in order to manufacture a practice guideline holding up that drug as the best drug among two whole classes of related drugs for treating people who were classified as ‘schizophrenic,’ the other drugs being marketed by other drug companies. This created what is widely considered the ‘standard of care,’ the treatment that therapists are supposed to follow and that they can use in the knowledge that they are well protected from lawsuits if they follow it and their patients are harmed. The very foundation of the guideline, that it was about ‘Schizophrenia,’ is illegitimate, because – though this will surprise many people – that category has been shown to be unscientifically created and indeed has been called a wastebasket for a wide variety of feelings and behavior, many of which are caused by psychiatric drugs.”

“Part two: After the triumvirate received a bonus of $65,000 for creating the guideline [‘treat schizophrenia with Risperdal’] speedily, their top psychiatrist wrote to the same drug company, announcing that the three had constituted themselves as an entity that was prepared, in return for about another half million dollars, to create a marketing plan for the drug. The details included finding ‘key opinion leaders’ (KOLs), who were prominent professionals in powerful positions – such as heads of state mental health or prison systems – and having them teach the Continuing Education courses that professionals are required to take, the ultimate message of those courses being that that particular drug [Risperdal] was the best one to prescribe. Another section of their marketing plan was to have a great many articles published in what are considered scientific or medical journals, all concluding that that drug was effective and should be prescribed.”

“It is not clear whether the three psychiatrists were directly involved in choosing the content of the journal articles, but the plan to produce such articles was carried out, leading to publication of pieces recommending use of the drug [Risperdal] to treat not only Schizophrenia but also Childhood Onset Schizophrenia, Schizo-affective Disorder, Bipolar Disorder in Children and Adults, Mania, Autism, Pervasive Developmental Disorder other than Autism, Conduct Disorder, Oppositional Defiant Disorder, Psychosis, Aggression Agitation, Dementia, below average IQ, and disruptive behavior. Thus, a staggering array of psychiatric categories – many of which are as scientifically sketchy as Schizophrenia – was used to promote the drug. This massive marketing campaign proceeded despite the many major negative effects of Risperdal, including drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, heartburn, dry mouth, increased saliva production, increased appetite, weight gain, stomach pain, anxiety, agitation, restlessness, difficulty falling asleep or staying asleep, decreased sexual interest or ability, vision problems, muscle or joint pain, dry or discolored skin, difficulty urinating, muscle stiffness, confusion, fast or irregular pulse, sweating, unusual and uncontrollable movements of face or body, faintness, seizures, Parkinsonian symptoms such as slow movements or shuffling walk, rash, hives, itching, difficulty breathing or swallowing, gynecomastia in male children, painful erection of penis lasting for hours…and death.”

“Who are the characters in this mystery? Janssen Pharmaceuticals, a division of Johnson & Johnson, is the drug company, and Risperdal is the drug in question. The marketing term for Risperdal and similar drugs is ‘anti-psychotic,’ but the accurate term is ‘neuroleptic,’ reflecting the mechanism of suppressing the brain’s activity as a powerful tranquilizer. Dr. David Rothman, who wrote the expert witness report for one of the lawsuits about the marketing of Risperdal, revealed after scrupulous examination of vast numbers of internal emails between Janssen staff and the representative of the three psychiatrists, is a specialist in medical ethics and the Bernard Schoenberg Professor of Social Medicine at Columbia College of Physicians and Surgeons, the medical school of Columbia University. He is also director of the Center for the Study of Science and Medicine at Columbia and at the time of writing his expert witness report was president of the Institute on Medicine as a Profession. Rothman stated in his report that the [treatment] guidelines [for Risperdal] were constructed ‘in disregard of professional medical ethics and principles of conflict of interest,’ and that they ‘subverted scientific integrity, appearing to be a purely scientific venture when it was at its core, a marketing venture for Risperdal’.”

“The psychiatrist who spearheaded these [Risperdal marketing] efforts is Dr. Allen Frances, who the year before teaming with Janssen oversaw the publication of the fourth volume of the ‘Bible’ of hundreds of categories of mental illness, Diagnostic and Statistical Manual of Mental Disorders, sales of which topped $100 million as a result of marketing by the lobby group called the American Psychiatric Association, which published it. By virtue of this position, he has been called the world’s most important psychiatrist. At the time, he was also Chair of the Department of Psychiatry at Duke University. The two psychiatrists who with Frances shared the nearly $1 million in payments from Janssen are Dr. John P. Docherty, who was then Professor and Vice Chairman of Psychiatry at Cornell University at the time, and Dr. David A. Kahn, who was Associate Clinical Professor of Psychiatry at Columbia University.”

“Now back to the mystery: Despite five individual stories in major media outlets in 2011, 2012, and 2014 about two huge Risperdal court cases filed by the state of Texas and joined by many other states, neither a single writer of any of these stories nor even the papers filed for the court cases named Frances, Docherty, or Kahn or described the fundamental roles played by their Practice Guideline and their marketing plan in the scandal. The mystery is deepened, because the authors of the media stories and the court documents did name and describe the roles of some of the KOLs [key opinion leaders], who assuredly were guilty of unethical conduct but whose participation was conceived of by Frances and his colleagues. And some of those who reaped huge financial profits from Risperdal’s false marketing – most notably Harvard University’s Dr. Joseph Biederman, who created an empire based on claims that ‘Bipolar Disorder in Children’ had been woefully underdiagnosed and untreated – have been royally outed for the enormous sums they earned. But even respected investigative journalist Steve Brill, who recently completed a unique, 15-part story of the Risperdal scandal for Huffington Post, and who described in detail many of its players and some of the patients who suffered terrible harm from the drug and who elegantly described the way that Janssen covered up data about some of the harm, left out the essential roles the Frances triumvirate played. Activist Vera Sharav of the Alliance for Human Research Protection published an online article about the Rothman Report and included the names of Frances and those two colleagues, her article was apparently picked up by only two or three bloggers and none of the major media reporters who read what she posts.”

There is more. Much more. I suggest you read Caplan’s entire article. In a half-sane world, she would have been awarded the highest possible honors for her work.

Risperdal. The long and winding trail. The severe damage. The hustle, the con. The crimes.

The lack of criminal prosecutions.

Brought to you by high authorities in the psychiatric profession and their allies.

A public revolt against the drugs and the pushers is necessary to stem the tide of poisoning.

Read More At: JonRappoport.wordpress.com
_______________________________________________________________

Jon Rappoport

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

The Stunning Secret Behind The Thousands Of Xarelto Lawsuits

FakeNews
Source: JonRappoport.wordpress.com
By: Jon Rappoport
May 8, 2017

(A note to my readers. My site, NoMoreFakeNews.com, is still down. We’ve pinpointed the problem, and we’re working to fix it. My blog, where I publish all my articles, is fine. And so is my email list. Feel free to sign up. Thanks for your patience and continued support. My work, as always, continues.)

Welcome to the circus, boys and girls. Parades, animals, acrobats, clowns, all colluding to approve lethal drugs for public use! Watch people take the drugs and fall down, watch them carted off in colorful cars to hospitals, where the doctors will have no idea what’s causing the life-threatening injuries! It’s wild, it’s crazy, and it’s brought to you by drug companies and their enablers at the FDA! It’s all covered by insurance. We’ve got cotton candy, popcorn, ice cream for the kiddies, and everybody can get in under the big tent! It’s the biggest game and the biggest hustle in town!

Recently, I wrote about the 18,000 lawsuits against Xarelto. Here is a quick recap:

The first court test of Bayer/J&J’s billion-dollar bonanza, blood-thinner, Xarelto, is coming up in New Orleans next week. The outcome will influence how the 18,000 lawsuits behind it will be handled.

The plaintiff in the first suit is Joseph Boudreaux. “While Xarelto was supposed to help cut his stroke risk, Boudreaux says it instead caused internal bleeding that required a week-long hospital stay in the intensive-care unit, several blood transfusions and multiple heart procedures. ‘I don’t want anybody else to suffer like I have from that drug,’ the part-time security guard says,” reports the Chicago Tribune.

Lawyers for Bayer and J&J will argue, in the main, that Xarelto was approved by the FDA as safe and effective.

This is the normal front-line strategy. “Well, the government says our drug is safe and effective, so what else do you want from us? We’ve done our duty. We’re off the hook.”

All right, that’s my recap.

BUT suppose the drugmaker and the government (FDA) both cheated and lied and committed multiple crimes, during the clinical trials of the drug leading up to its approval for public use?

It turns out someone has been investigating those clinical trials of Xarelto, and he has uncovered stunning secrets. His name is Charles Seife. He is a professor of journalism at New York University.

Lawyers for the plaintiffs in the 18,000 lawsuits against Xaraelto, take notice. This is information you want to have at your fingertips. Seife can provide many details—here I’m just presenting his overview.

Buckle up.

Professor Seife writes, at Slate, about the four human clinical trials of Xarelto. These were called the RECORD trials; RECORD 1, 2, 3, and 4:

“The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire RECORD study to be ‘unreliable.’ Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.”

Seife is pointing out that the FDA never alerted The Lancet that the published report on the Xarelto clinical trials was false through and through.

Seife continues: “RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban (Xareltio) studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.”

“The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception.”

Basically, Seife is stating that the FDA found horrendous distortions in the clinical trials of Xarelto—and yet the agency approved the drug, as safe and effective, for public use.

—And then people taking the drug began to experience dire “adverse effects,” like uncontrolled bleeding.

And now we have 18,000 lawsuits against Xarelto’s parents, Bayer and J&J.

What about lawsuits against the FDA? That’s a tougher hill to climb for lawyers. Because the FDA is “the government.”

I’ve written many articles about the criminal agency called the FDA (article archive here). For stark revealing light, consider an interview relentless medical reporter, Martha Rosenberg, conducted with an FDA employee, whose job was reviewing new drugs and offering an assessment of their safety and efficacy, prior to agency approval or rejection.

Here is what I wrote in one piece:

In a stunning interview with Truthout’s Martha Rosenberg, former FDA drug reviewer, Ronald Kavanagh, exposes the FDA as a relentless criminal mafia protecting its client, Big Pharma, with a host of mob strategies.

Kavanagh: “…widespread [FDA] racketeering, including witness tampering and witness retaliation.”

“I was threatened with prison.”

“One [FDA] manager threatened my children…I was afraid that I could be killed for talking to Congress and criminal investigators.”

Kavanagh reviewed new drug applications made to the FDA by pharmaceutical companies. He was one of the holdouts at the Agency who insisted that the drugs had to be safe and effective before being released to the public.

But honest appraisal wasn’t part of the FDA culture, and Kavanagh swam against the tide, until he realized his life and the life of his children was on the line.

That’s what I wrote, and considering what has happened in the case of Xarelto, Kavanagh’s statements take on very specific meaning:

The FDA colludes with a drug manufacturer to hide the dangers of a new drug that should never have been approved.

The drug is approved.

The drug assaults people and causes grievous harm.

Based on this article, and many others I’ve written exposing the FDA, I would say the agency is in charge of internal and domestic chemical warfare against the American people.

There. Is that clear enough?

Update—the first lawsuit against Xarelto, in New Orleans, has just been decided by a jury. They have ruled in favor of the drug companies, Bayer and J&J, and against the plaintiff, Joseph Boudreaux.

The major (narrow) issue in the case seems to have come down to this: did the drug companies failed to warn physicians about bleeding risks associated with Xarento?

The jury said Bayer and J&J DIDN’T FAIL TO WARN.

End of story.

The madness continues.

This is what happens when plaintiffs’ lawyers are too dim to see the big picture I presented in this article—or when a presiding judge keeps denying the right to introduce relevant evidence against a drug.

What about the 18,000 Xarelto lawsuits against Bayer and J&J that are waiting in the wings? Right now, the plaintiffs’ lawyers are scrambling to re-think their strategies.

It’s possible that, eventually, all 18,000 cases will be settled, not tried in court. If that happens, the people who have been damaged by Xarelto could each receive a minimal payout for their suffering.

NOTE TO PLAINTIFFS’ LAWYERS: Reveal, in court, the criminal collusion between the FDA and Bayer and J&J. Expose the crimes they committed in order to get the highly dangerous Xarelto approved for public use in the first place—when it should have been rejected and all the stocks destroyed.

Put THAT in front of a jury.

Read More At: JonRappoport.wordpress.com
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Jon Rappoport

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

American Academy of Pediatrics declares “no science” needed to prove vaccines are safe, because they BELIEVE

Image: American Academy of Pediatrics declares “no science” needed to prove vaccines are safe, because they BELIEVE
Source: JeremyHammond.com
Jeremy Hammond
May 7, 2017

When asked whether it could provide studies to support specific claims it made about vaccine safety, the American Academy of Pediatrics ultimately declined.

On January 10, 2017, the American Academy of Pediatrics (AAP) issued a press release to express its opposition to a federal commission that has been proposed by the Trump administration to examine vaccine safety and efficacy. The AAP argues that since we already know that vaccines are safe and effective, therefore there is no need for further examination into their safety and efficacy.

This argument, however, begs the question — it presumes in the premise the proposition to be proven (the petitio principii fallacy). And the press release itself illustrates why, apart from the question of whether there should be a federal commission, critical examination of public vaccine policy is very much warranted.

In its press release, among other things, the AAP stated that:

  • Vaccines prevent cancer.
  • Claims that vaccines are linked to autism “have been disproven by a robust body of medical literature”.
  • Claims that vaccines “are unsafe when administered according to the [CDC’s] recommended schedule” have likewise “been disproven by a robust body of medical literature”.

According to the AAP, its own claims are backed by solid science. Yet when asked whether it could provide citations from the medical literature to support its claims, the AAP first failed to do so, then essentially offered a “No comment” when pressed for a comment about its failure to do so.

With respect to the claim that vaccines prevent some forms of cancer, the AAP was asked:

  • Can you please direct me to any studies in the peer-reviewed medical literature showing any vaccine prevents cancer?

With respect to the other two, the AAP was asked the following questions:

  • Can you please direct me to the studies you are referring to in this body of literature that took into account the possibility of a genetically susceptible subpopulation?
  • Can you please point me to the studies in this body of literature that have compared health outcomes, including but not limited to developmental regression (i.e., autism), for children who’ve receive the CDC’s full schedule of vaccinations with children who’ve remained completely unvaccinated?

An initial email to the AAP containing these questions went unanswered.

The email was followed up with a phone call. Lisa Black, the AAP’s Media Relations Manager, assured that she would get back with answers to the questions. In a subsequent email, Ms. Black replied, “Please see information that AAP has posted for parents on this page”, which was followed by a link to a list of studies on the website HealthyChildren.org.

However, none of the listed studies on that page supports the AAP’s claim that “vaccines prevent … forms of cancer”.

None apparently considered the possibility of a susceptible subpopulation with a genetic susceptibility to adverse reactions to vaccines.

And none compared health outcomes of fully vaccinated children with completely unvaccinated children.

The list provided does contain numerous studies finding no association between vaccines and autism, but even the listed safety review by the Institute of Medicine (IOM) doesn’t go so far as to say that the hypothesis has been “disproven”.

On the contrary, the IOM acknowledges that it is biologically plausible that vaccines might cause autism in a genetically susceptible subpopulation, but characterizes this hypothesis is still “speculative” and “unsubstantiated”.

That is a world apart from saying it has been “disproven”.

One would think that the IOM’s conclusion, if its inquiry was a scientific one, would be that since this is such an important question and this specific hypothesis is plausible and not well studied, therefore there should be further study into this question of whether vaccines could trigger autism at least in some children with a genetic predisposition to vaccine injury.

But rather than calling for more research into this area, the IOM actually advocated that no further studies to test this hypothesis be done. Its stated reason for this was partly medical, but at least equally political — and certainly favorable to the profits of the pharmaceutical industry. The IOM’s reason was:

Using an unsubstantiated hypothesis to question the safety of vaccination and the ethical behavior of those governmental agencies and scientists who advocate for vaccination could lead to widespread rejection of vaccines and inevitable increases in incidences of serious infectious diseases like measles, whooping cough, and Hib bacterial meningitis.

In other words, since studying this hypothesis further would undermine public vaccine policy with its one-size-fits-all approach to disease prevention, therefore no further research to test the biologically plausible hypothesis should be done.

The AAP was sent a follow up email noting that none of the studies listed appeared to support the claims it made in the press release. The AAP was welcomed to correct the record, but did not dispute the observation that none of the studies listed showed that vaccines can prevent cancer, considered genetic susceptibility to vaccine injury, or compared health outcomes for vaccinated and unvaccinated children.

The additional follow up questions were also asked:

  • If the AAP cannot produce one or more studies that considered the possibility of a genetically susceptible subpopulation, how can it claim that any association between vaccines and autism has been “disproven”?
  • If the AAP cannot produce one or more studies that compared health outcomes between children vaccinated according to the CDC’s schedule and children who remained unvaccinated, how can it claim that any association between vaccines and autism has been “disproven”?

The AAP did not reply via email to the follow up questions.

In a second phone call requesting the AAP to produce such studies to support its claims, Ms. Black replied that she had provided everything the AAP was going to provide.

When confronted with the observation that none of the studies provided supported the AAP’s claim that vaccines can prevent cancer, she repeated that the AAP was not going to provide any additional information.

When asked whether the authors of the press release, AAP President Fernando Stein and Executive Vice President Karen Remley, would like to comment, Ms. Black abruptly ended the phone call by saying she was going to hang up and then doing so.

Questions Unanswered

The questions seem pertinent, particularly given the fact that the government has acknowledged that vaccines can cause brain damage resulting in developmental regression.

In 2008, then director of the CDC Julie Gerberding offered the following carefully worded acknowledgment:

Now, we all know that vaccines can occasionally cause fevers in kids. So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with a mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

The context in which she was speaking was with respect to Hannah Poling, a child with a mitochondrial disorder who developed autism after receiving numerous vaccines on the same day and whose family was awarded compensation under the National Vaccine Injury Compensation Program (VICP).

The VICP was established in the mid-1980s under a law that granted broad legal immunity to vaccine manufacturers. The government’s reason for doing so was that vaccine injury lawsuits were threatening to undermine public policy by putting vaccine manufacturers out of business.

The Supreme Court has upheld that legal immunity on the grounds that certain adverse reactions are “unavoidable” and “design defects” are “not a basis for liability.”

Around the same time as Gerberding’s admission, a former director of the National Institutes of Health, the late Bernadine Healy, criticized the refrain that any link between vaccines and autism has been debunked. She pointed out the kinds of studies that would be necessary in order to confidently draw that conclusion hadn’t yet been done.

Specifically, she noted the lack of studies taking into consideration a genetically susceptible subpopulation.

Ms. Healy also slammed the IOM for advocating that no further research be done and noted that as a potential cause of autism, “vaccines carry a ring of both historical and biological plausibility”.

Similarly, in contrast to the AAP’s claim that any association between vaccines and autism has been “disproven”, one of the CDC’s lead researchers on that very question, CDC Director of Immunization Safety Dr. Frank DeStefano, admitted in an interview in 2014 that “it’s a possibility” that vaccines could trigger autism in genetically susceptible individuals.

“It’s hard to predict who those children might be”, DeStefano observed, and trying to determine what underling conditions put children at risk of vaccine injury is “very difficult to do”.

Acknowledging the lack of studies in this area, he added that, “if we ever get to that point, then that kind of research might be fruitful.”

The AAP’s list of studies includes one or more for which DeStefano was an author.

The CDC also admits the need for further study in this area. Its website at the time of this writing acknowledges that “More research is needed to determine if there are rare cases where underlying mitochondrial disorders are triggered by anything related to vaccines.”

So how can the AAP claim that any association between vaccines and autism has been “disproven” when the studies that would be necessary to invalidate the hypothesis haven’t been done?

No comment.

That’s the AAP’s answer to the question, anyway.

The AAP’s attitude should perhaps come as no surprise, given its close relationship with the vaccine industry.

As CBS News reported in 2008, “The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters.”

A Discussion to Be Had

The AAP argues in its press release against the formation of a federal commission, but its argument would apply to any public debate about the safety and efficacy of vaccines. By the AAP’s logic, like the IOM’s, also unnecessary are any discussion about it in the media and any further scientific inquiry.

But as Daniel Sarewitz observes, “as science approaches the cutting edge, it tends to raise as many questions as it resolves, so there is always room for debate about what the science is actually saying.”

Parents dubbed “anti-science” by the media are naturally curious why that label doesn’t seem to apply to those calling for no further inquiry into pertinent questions.

Parents aren’t just asking legitimate questions about vaccines. They’re doing what most doctors haven’t and spending a lot of time researching vaccines themselves. And they’re not just going to “anti-vaccine” websites to research it. They’re organizing, sharing information, and digging into the medical literature for themselves.

Parents can see the fundamental contradiction between public health officials and the media constantly insisting that vaccines are harmless even while the government grants legal immunity to the vaccine manufacturers on the grounds that vaccines are unavoidably unsafe and while the government manages a Vaccine Injury Compensation Program in order to shift the costs for damages and keep the vaccine manufacturers profitable — all to maintain public policy.

Parents understand how government and industry funding influences the direction and findings of scientific research, and how the medical establishment that has given us soaring costs and a population in which nearly 40 percent are chronically ill will tend to justify itself despite its abysmal performance and a long history of being wrong time and again, from tobacco science (older generations may remember how the industry used to get product endorsements from doctors) to the USDA recommended high-carb diet (which has contributed to the obesity epidemic and is more about satisfying food industry lobbyists than providing science-based advise) to the role of cholesterol in heart disease (scientific research no longer supports the hypothesis that dietary cholesterol contributes to blood cholesterol and heart disease risk).

Parents are aware of how government agencies like the FDA and the CDC serve the financial interests of the pharmaceutical industry. They see the corruption and the “revolving door” of Washington, such as how Julie Gerberding left her government job pushing vaccines as head of CDC to become president of the vaccine division for the pharmaceutical giant Merck.

They see how the AAP, too, has an incestuous relationship with “Big Pharma”. They understand how willful ignorance goes beyond the individual operating within the system and becomes institutionalized. And they watch as an organization that influences how their child’s pediatrician practices medicine accepts money from an industry they feel the AAP ought to be protecting them from.

They can witness how the AAP makes statements it claims are solidly backed by science, but which it is unwilling or unable to provide any studies to support. They understand that the truly “anti-science” position is the one that says no further scientific inquiry into an admittedly biologically plausible hypothesis is necessary.

Parents know there are many studies that have found no association between vaccines and autism. They don’t need the AAP to point this out to them. But they wonder why the AAP ignores all the studies that do support the hypothesis.

They wonder how the AAP can claim that the vaccine-autism hypothesis has been “disproven” when the most any of the studies it cites have concluded is that those particular studies, with their own particular focus, designed around their own particular assumptions, using a particular methodology, did not find an association between vaccines and autism.

And parents are asking questions like: What was the actual purpose of the study? What were the underlying assumptions made by the authors? What vaccines were being studied, and what outcomes? Who were the study groups? What were the criteria for their selection? What was the study’s methodology? What are its strengths and weaknesses? Do the conclusions drawn follow from the actual findings? How conclusive is it? What does the study actually prove, if anything?

Parents can see for themselves the huge disparity between what they are told science has to say about vaccines  — by public health officials, the medical establishment, and the mainstream media — and what science actually has to say about it.

The parents who are choosing not to vaccinate their children aren’t doing so because they are uneducated or unintelligent. On the contrary, studies show that they tend to be wealthier and more highly educated than the general population.

They aren’t choosing not to vaccinate because they are ignorant of the science. They are choosing not to vaccinate because they are digging into the medical literature (which can be searched via PubMed.gov) and awakening to the deceit they see coming out of the government and the mainstream media.

They see how mainstream journalists, rather than seriously investigating what the science actually says, rely on statements from agencies like the CDC and industry-funded organizations like the AAP to “inform” the public about the subject.

They see how the establishment is seeking to stifle debate not by respectfully addressing their legitimate questions, but by bullying them into silence and conformity, and they understand how such a phenomenon can arise because institutions with a life of their own feel threatened by the truth and act to preserve the status quo.

The AAP and other actors interested in preserving the public vaccine policy so far seem to have assumed that they can end the discussion by declaring authoritatively that there is no need for further discussion.

But if they ever hope to truly end the discussion, they are going to have to start taking parents’ concerns seriously and answering their legitimate questions with more than disingenuous public relations talking points that might as well have been written by the vaccine industry.

Read More At: NaturalNews.com