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The study, published May 9 in JAMAshows that 71 of the 222 drugs approved during that time period were withdrawn, required a “black box” due to their side effects, or warranted a safety announcement about new risks.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

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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

The deepest secrets of Obamacare

Image result for obamacare failure
Source: NoMoreFakeNews.com
Jon Rappoport
October 17, 2016

Press reports indicate Obamacare is in a death spiral, because its structure is unworkable. Premiums are escalating beyond reason, insurers are opting out, and efforts to prop it up are at best a temporary fix.

But when has one of its failed programs ever stopped the federal government from pushing ahead? Increase the debt, fund the whole mess, task PR people to tell one lie after another.

There are hundreds (or more) satellite bureaucracies that have been birthed to support Obamacare, expand its reach, and develop strategies for bringing the whole nation under the umbrella of a national health care system. These “planners” are busy generating schemes for mandatory vaccination, increased psychiatric screening for children, lifetime tracking of patients, etc. The planners revel in devising systems (any systems) that corral huge numbers of people within one-size-fits-all solutions. If you told them there was a new federal program to identify all Americans who use the term ‘individual freedom’ and send their vital statistics to the FBI and the Pentagon, they would jump in with both feet, without a second thought.

But the real secret of Obamacare is in plain sight: it’s the medical treatment itself.

As soon as the proposed bill to create Obamacare was sent to Congress, I began writing about what was in store for Americans. Here is a later article I wrote in 2012, after a constitutional challenge failed:

—June 28, 2012—

I want my Obamacare! I want my Obamacare!

Well, you’ve got it. The US Supreme Court just upheld it by calling the individual mandate a tax.

Those who shout victory to the rooftops have no idea what’s in store for them. No idea at all.

It’s vital to look at the real effects of this sinister plan. It’s all about the effects of mainstream medicine. That’s what the sold-out press is refusing to examine.

The “share and care” humanitarian mask will be peeled away. The US Dept. of Health and Human Services will create, as ordered, a complete list of approved treatments for every disease-label under the sun. And everyone in the insurance plan (everyone in America) will be forced to take what the doctor tells them to take.

For a bonus, unapproved treatments will be banned. People and practitioners who try to use alternative treatments will find themselves in trouble.

This is the hidden agenda of Obamacare. This is what it will morph into in the future—unless it is repealed by the Congress.

I’m not dreaming or fantasizing. I’ve been following and reporting on the medical cartel for 30 years, and I know the mindset of these people, these doctors, these bureaucrats, these pharmaceutical string-pullers behind the scenes. Obamacare is right up their alley. It’s about control, so it’s an answer to their prayers.

So what do we know about their mainstream medicine, the hospital-based drug-addled modern version?

On July 26, 2000, the Journal of the American Medical Association published a landmark paper by Dr. Barbara Starfield (Johns Hopkins School of Public Health), “Is US health really the best in the world?” In it, Starfield revealed what many people inside the medical establishment already knew: every year, like clockwork, the medical system was killing huge numbers of people.

Each year in the US, as Dr. Starfield reported, there are:

* 12,000 deaths from unnecessary surgeries;

* 7,000 deaths from medication errors in hospitals;

* 20,000 deaths from other errors in hospitals;

* 80,000 deaths from infections acquired in hospitals;

* 106,000 deaths from FDA-approved correctly prescribed medicines.

The total of medically-caused deaths in the US every year is 225,000.

This makes the medical system the third leading cause of death in America, behind heart disease and cancer.

In the wake of Starfield’s devastating report, other facts came to light: 2.1 million people in America, every year, are hospitalized as a result of reactions to FDA-approved medicines. Annually, 36 million serious adverse reactions to those drugs occur.

So, inclusive health coverage for many more Americans under the Obama Plan means these horrendous figures will rise.

This is the dirty secret.

Obama and his allies are promoting a medical system that is the third leading cause of death in America. It’s that stark and it’s that simple.

The Obama Plan involves appointing an “expert panel” to decide what treatments Americans should be given for what diseases, under the new regime.

Only a certified idiot would assume that, over time, alternative non-mainstream therapies would survive such an ongoing vetting. Hope may spring eternal, but common sense makes it easy to grasp the realities on the ground.

In the long run, alternative therapies will be edged out. Those that remain will be permitted for a narrow range of conditions, or as adjuncts to standard drug treatments and surgery.

Chiropractors and acupuncturists, who are temporarily basking in the notion that Obama “really cares,” are in for a very rude awakening. Their careers and practices will be significantly reduced. Not today, not tomorrow, but it will happen.

Doctors, under the Plan, will be telling patients they may not take nutritional supplements while in treatment. This will assume the status of an irreversible edict. In many cases, “while in treatment” will mean years.

What happens to a person, conscripted into the mandated Insurance Plan, who is told by his doctor that he should/must receive a vaccine? Suppose this person says no? What are the consequences? Will he then be labeled a defector? What penalties will he suffer?

Does a diagnosis of cancer imply a patient must submit to chemotherapy, radiation, and surgery? Can these treatments be forced upon him?

Perhaps, in the early days…

Continue Reading 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 emails at NoMoreFakeNews.com or OutsideTheRealityMachine.

Taking Antidepressants During Pregnancy Adversely Affects Babies’ Brain Chemistry, Finds Study

[Editor’s Note]

For those wishing for more information about this important subject please read:

A Mind Of Your Own – The Truth About Depression & How Women Can Heal Their Bodies by Dr. Kelly Brogan
Toxic Psychiatry – Dr. Peter Breggin

Pregnant women
Source: NaturalNews.com
Isabelle Z.
June 24, 2016

There is now another reason to be concerned about the effects of antidepressant use, particularly if you’re pregnant. A new study out of the Helsinki University Children’s Hospital has uncovered a link between the use of antidepressants by pregnant women, and brain abnormalities in their newborns.

Unfortunately, 15 percent of pregnant women are believed to suffer from depression or anxiety, and around 5 percent of the babies born in the U.S. each year are believed to be exposed to antidepressants in the womb.

Researcher Sampsa Vanhatalo said: “We found many changes in the brain activity of SRI-exposed newborns. Since the changes did not correlate with the mother’s psychiatric symptoms, we have assumed that they resulted as a side effect of maternal drug treatment.”

The researchers are calling for more investigations into the effects of these drugs on fetal brain function. They emphasize the importance of choosing non-pharmacological interventions to treat anxiety and depression in pregnant women.

This study was the first one that directly studied SSRI exposure’s effects on newborn brain activity. It involved 22 mothers who were taking SSRI meds, and 62 controls who did not take any medication.

Some of the effects noted in the electrical activity in the brains of those who were exposed to SSRIs, include weaker synchronization between cortical rhythms, and lower levels of organization in the communication between brain hemispheres.

This study comes on the heels of another recent study that found permanent changes in the areas of the brain responsible for mood and cognition in the brains of mice whose mothers took SSRIs during pregnancy.

Antidepressant use during pregnancy linked to a number of risks

This finding joins a laundry list of other developmental and fetal complications that have already been linked to antidepressant use during pregnancy.

A study published in JAMA Pediatrics found a link between antidepressant use and the development of autism. In that study, University of Montreal researchers found that women who took SSRIs during their second and third trimester of pregnancy had twice the likelihood of giving birth to a baby who would go on to develop autism.

Autism is not the only issue mothers who take antidepressants might have to contend with as their children grow. Research from Canada’s McMaster University discovered that the use of SSRI antidepressants in pregnancy was correlated with obesity, diabetes, and other metabolic complications such as fatty liver in adult offspring.

Another potential risk associated with taking antidepressants during pregnancy is premature birth. A Danish study discovered that women who take SSRIs while pregnant have double the risk of giving birth prematurely than do women who do not take these drugs.

How can pregnant women deal with depression safely?

Even women who are not pregnant would do well to try alternative options for dealing with depression first, given the other serious side effects caused by antidepressants, including the tendency to commit suicide and carry out violent acts.

There are several methods that expectant mothers can use to cope with depression that do not have dangerous side effects for their unborn children. Some people are quick to dismiss alternative methods, but a study out of Johns Hopkins University actually found that meditation is every bit as effective as antidepressants in treating depression and anxiety. This is an excellent starting point for pregnant women, as it does not carry any potential risks.

In addition, eating the right foods can help, not only with depression, but also with giving your child the best start in life. This means eating organic fruits and vegetables and whole grains. Exercise and yoga can also help boost your mood, although pregnant women should use caution and avoid exercises that are too strenuous.

Spending some time outdoors connecting with nature is an often-overlooked yet effective method of dealing with depression. A Stanford University study found that people noted a decrease in negative self-talk after a 90-minute walk in nature, and brain scans actually showed less activity in the part of the brain that is active during the maladaptive thinking that is linked with depression.

The best news is that all of these approaches can bring about other benefits for your unborn child. Healthy eating means your baby won’t be exposed to the many toxins found in processed food, while getting more physical activity can boost your overall health.

Read More At: NaturalNews.com

Bombshell Study Admits Antidepressants Increase Suicide Attempts In Teens & Are Completely Worthless For Treating Depression

Antidepressants
Source: NaturalNews.com
Julie Wilson
June 13, 2016

A bombshell study published in the medical journal The Lancet admits what Natural News and others in the holistic health community have been reporting for years: antidepressants kill. On Wednesday, researchers published the most comprehensive analysis to date of the safety and efficacy of widely prescribed antidepressants in children and teens.

What they found is that the majority of antidepressants prescribed to young people have far more risks than benefits, doing essentially nothing to ease symptoms of depression, while significantly increasing suicidal thoughts and suicide attempts, CBS News is reporting.

Out of 14 antidepressants analyzed by researchers, only one – fluoxetine (marketed under the name Prozac and Sarafem) – proved effective for relieving symptoms of depression better than a placebo pill. Venlafaxine (Effexor), on the other hand, was shown to increase the risk of suicidal tendencies in children and teens compared to a placebo and five other antidepressants.

The study results are major considering the fact that antidepressant use among young people is at an all-time high. Shockingly, children under 5-years-old are the fastest growing group being prescribed mind-altering drugs.

Most antidepressants do NOTHING to help depression, study finds

Antidepressant use among children and teens rose from 1.3 to 1.6 percent between 2005 and 2012, according to a separate study published in The Lancet.

As the authors of this latest study confirm, the implications of drugging children with powerful, mind-altering drugs is completely unpredictable, which is why international guidelines encourage doctors to use non-drug approaches including “cognitive behavioral or interpersonal therapy.”

Lead study author Dr. Andrea Cipriani says that because brains in children and teens are not yet developed, it’s important to lead with caution when prescribing medication, “because we don’t know the potential implications in the long term … .”

The U.S National Institutes of Health estimates that some 2.8 million children (or about 11 percent) between the ages of 12 and 17 have suffered from at least one episode of depression, for which we now know that antidepressant drugs are totally worthless.

Dr. Cipriani explains that depression in children differs widely from that of adults. “Not only is it still under-diagnosed and under-treated but also it tends to present in a different way,” he said. “Depressive symptoms in children and adolescents are rather undifferentiated. You notice more irritability, aggressive behavior and problems at school. And consequences of depressive episodes in children and adolescents are dramatic because they include impairments in their social functioning but also an increased risk of suicidal ideation and attempts.”

FDA privy to antidepressant harm in children for decades

The U.S. Food and Drug Administration has known for more than a decade that antidepressants pose immense harm to patients, particularly children, which is why it implemented “black box” warnings in 2004 for users under the age of 24. The labels clearly state that the drugs up your chances of becoming suicidal or intensify preexisting suicidal thoughts and behavior.

Yet, irresponsible physicians continue to push harmful drugs on children and teens that alter brain chemistry. Not only that, but doctors are increasingly prescribing the drugs for off-label uses.

This was substantiated just weeks ago in a study published in the May issue of the Journal of the American Medical Association (JAMA), which found that nearly half of people prescribed antidepressants aren’t even depressed.

After analyzing a decade of antidepressant prescription records, researchers concluded that only 55 percent were given for depression, while the remaining 45 percent was written for conditions such as anxiety, sleeping problems, pain, panic disorders and attention deficit hyperactivity disorder (ADHD).

Doctors prescribing depression pills for pretty much anything

Other off-label uses include digestive problems, eating disorders, migraines and menopausal symptoms. Twenty-nine percent of antidepressant prescriptions were written for off-label uses. The study authors expressed grave concerns about the fact that these drugs, which are proven to be dangerous, are being prescribed for conditions for which there is no evidence supporting their efficacy, or safety for that matter.

The reason doctors are pushing unproven drugs, is because they’re being advised to do so by Big Pharma, and not by scientific research, said the study authors.

Further illustrating just how worthless these drugs are, medical researcher Peter Gotzsche said last year that nearly all psychiatric drugs, including antidepressants, could be withdrawn from the market without damaging public health. In fact, he recommends it.

Read More At: NaturalNews.com

NO TREATMENT NEEDED: The US Population Could Cut Cancer Deaths In HALF Just By Adopting A Healthier Lifestyle

Cancer prevention
Source: NaturalNews.com
Amy Goodrich
June 7, 2016

Every year, cancer claims the lives of more than half a million Americans, making it the second leading cause of death in the United States. In 2015, a highly controversial paper was published that suggested that many cases of cancer are the result of random errors that cells make when they divide, or as they called it “bad luck.”

However, many studies have produced strong evidence that we need to stop thinking that cancer is down to bad luck or a result of factors beyond our control. A new study published in the journal JAMA Oncology found that new cases of cancer could drop by 20 to 40 percent, and cancer-related deaths could drop by half if we start adopting a healthier lifestyle.

Cancer deaths could be prevented

Researchers from Massachusetts General Hospital and the Harvard T.H. Chan School of Public Health analyzed extensive ongoing studies where they assessed the healthy lifestyle patterns and cancer incidence of 136,000 white American healthcare professionals.

The participants were divided into two groups: a low-risk group, who lived a healthy lifestyle, and a high-risk group, who did not.

The healthy lifestyle factors included moderate or no drinking, a BMI between 18.5 and 27.5, weekly physical activity and not smoking. The authors of the study claim that people who never smoked or stopped smoking, stayed fit, managed their weight, and had no more than a drink or two a day, dramatically slashed the risk of dying from cancer by half.

While it was no surprise that lung cancer deaths could be reduced by up to 80 percent through living a healthy, smoke-free life, they also reported that more than a fifth of the cases of colon cancer, pancreatic cancer and kidney cancer could be prevented if we change the way we live.

After extrapolation of the data to the U.S. population at large, the researchers found that for women, an estimated 41 percent of cancer cases and 59 percent of cancer deaths were preventable. For men, 63 percent of cancer cases were preventable, and a 67 percent reduced risk of death was recorded.

Prevention saves lives

There were a few limitations to the study. All the participants included in the study were white; the high-risk group in the study was healthier than the general U.S. population; and dietary habits were not taken into account.

Nonetheless, these findings reinforce the strong link between lifestyle factors and cancer. Therefore, prevention, not the development of new treatments, should become the primary focus to control this dreadful disease that claims so many lives.

An accompanying editorial, co-authored by Harvard Chan School adjunct professor of epidemiology Graham A. Colditz, noted that most cancer is preventable.

“As a society, we need to avoid procrastination induced by thoughts that chance drives all cancer risk or that new medical discoveries are needed to make major gains against cancer, and instead we must embrace the opportunity to reduce our collective cancer toll by implementing effective prevention strategies and changing the way we live.”

Herewith, the authors refute the idea that the development of most cancers is a matter of random cell mutations and bad luck. Our actions matter. The authors call on people and policymakers to be more active in engaging in and encouraging healthy habits.

Read More At: NaturalNews.com

Medical Journal Openly Admits 50% Of People On Antidepressants Don’t Even Have Depression

Antidepressants
Source: NaturalNews.com
David Gutierrez
June 7, 2016

Nearly half of people taking depressants are not suffering from depression at all, according to a study conducted by researchers from McGill University in Montreal, and published in the Journal of the American Medical Association (JAMA).

These people have been prescribed the drugs for “off label” uses not approved by drug regulatory agencies. These uses have never been proven safe or effective.

“It’s an interesting phenomenon,” author Jenna Wong said. “We had heard that in the scientific community there has been a suspicion among doctors that physicians are commonly prescribing antidepressants for uses other than depression. We also found that for the major classes of antidepressants, there was an increasing prescribing trend over time.”

Treatments not backed by evidence

The researchers reviewed 10 years of antidepressant prescription records, containing data on more than 100,000 prescriptions written by approximately 160 doctors for nearly 20,000 patients. They analyzed trends of prescribing for every antidepressant class except monoamine oxidase inhibitors, which are almost never prescribed as antidepressants anymore and therefore rarely occurred in the records.

They found that only 55 percent of the prescriptions were written for depression. The other 45 percent were written for anxiety (18.5 percent), insomnia (10 percent), pain (6 percent), panic disorders (4 percent), and for a slew of conditions that are off-label for every antidepressant, including attention deficit hyperactivity disorder (ADHD), digestive disorders, eating disorders, migraine and vasomotor menopause symptoms.

Twenty-nine percent of antidepressant prescriptions were written for a use that was off-label for that particular drug. Fully 66 percent of prescriptions written for conditions other than depression were off label.

If nothing else, the study shows that rates of antidepressant prescriptions are a not a good indicator of the rate at which depression is being diagnosed, or treated, the authors noted. It also raises concerns that the drugs are being so widely used for conditions not backed by scientific research.

“The findings indicate that the mere presence of an antidepressant prescription is a poor proxy for depression treatment, and they highlight the need to evaluate the evidence supporting off-label antidepressant use,” the authors wrote.

Deadly placebos

Wong noted that off-label uses have never been proven effective, and may also carry a risk of unknown side effects.

“I can’t make a statement to say that for sure they don’t work or that they are exposing patients to health risks but there’s the possibility that they could be causing adverse health effects or that they may not be effective for the conditions,” Wong said. “Without any scientific evidence, it’s hard to be able to say.”

“It raises the question of why they are prescribing them,” she said.

The authors speculated that many doctors are relying on tradition or informal channels of information, rather than scientific research.

“Physicians may be talking to their colleagues and saying, ‘Hey, I’ve used this drug in my patient population and it works,'” Wong said. “So it’s more word of mouth.”

Other potential reasons for off-label prescribing may be marketing by pharmaceutical companies or simply the use of antidepressants as a last resort when other treatments have failed.

“Some of these conditions are things where there is no exact treatment,” Wong said. “The patients may be desperate for something to treat their ailments.”

The findings are particularly troubling given how many studies have shown that antidepressants have little, if any, benefit over a placebo – but with a much higher rate of potentially dangerous side effects, including suicide.

In an article published last year in the British Medical Journal, esteemed evidence-based medicine researcher Peter Gotzsche argued that nearly all psychiatric drugs, including antidepressants, could be discontinued without harming public health. In fact, he said, there would probably be a benefit; currently, these drugs kill 500,000 people per year – and that’s just for people over the age of 65 living in Western countries.

Read More At: NaturalNews.com