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Yale Study Reveals 1 in 3 Drugs Have Safety Issues Even After FDA Approval

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In 2014, Harvard University stated that prescription drugs are the 4th leading cause of death, yet pharmaceutical companies continue to hide behind their profits and promote their products as safe. Doctors and even their patients are willing to turn a blind eye to many of the adverse side effects of drugs, opting for the “bandaid” effect they provide instead of seeking alternative treatments and preventative methods.

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A recent study published in the Journal of the American Medical Association and conducted by a team of researchers from Yale University studied the effectiveness of the FDA’s drug approval process. The team discovered that nearly one in three drugs that the FDA tests and approves ends up having safety issues.

-->Listened to our latest podcast episode yet? Joe and Dr. Madhava Setty deliver a special report aimed at gaining clarity around the COVID-19 vaccine. Is it safe and effective? Can it actually change your DNA? Click here to listen!

Research Finds Serious Issues With FDA Drug Approval Process

In order to establish whether or not pharmaceutical drugs are safe for consumers, the FDA implements drug testing and clinical trials. These trials typically test fewer than 1,000 patients over a short timeframe, usually around six months or less. The Yale researchers suggested that safety issues could only truly be detected if more patients were studied over a longer period of time, speaking to the ineffectiveness of the FDA’s testing.

To identify how to effectively determine any safety issues with pharmaceutical drugs, the Yale researchers studied data on new drugs approved between 2001 and 2010, with follow up through 2017. Their findings proved that approximately 32% of new drugs approved by the FDA had notable safety issues.

A shocking 71 of the 222 drugs approved within this timeframe were withdrawn, had a “black box” warning regarding the side effects, or required a safety announcement to the public about newfound risks. This begs the question: Why are these drugs being approved in the first place if they warrant so many safety concerns?

“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,” explained Associate Professor of Medicine and Public Health Dr. Joseph Ross, who led the research team.

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The researchers also specified characteristics of pharmaceuticals that were more likely to pose a higher risk of safety issues to patients, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway. The accelerated approval process often uses surrogate endpoints, which means that the researchers measured a factor other than survival, such as tumour size, to figure out whether the drugs should be approved.

“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross further elaborated. “In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross stated. The Yale team’s previous studies exposed that the FDA approval process for drugs is much faster than that of other government organizations in Europe, which is interesting given the nature of the business in both countries. Prices of drugs are far higher in America than they are abroad, and Americans take a lot more drugs, meaning U.S. pharmaceutical companies make a lot more money.

The timing of this study is interesting too, as the FDA has been facing increased pressure lately to quicken the drug approval 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 concluded.

Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, weighed in on the study, commending the researchers for their work. “It’s important to keep in mind that the post-approval safety issues cover the spectrum from relatively minor to serious,” Alexander said.

“A good next step would be to dig into the extremely serious safety problems, determine whether the FDA could have flagged them sooner and how they might have been missed,” he continued.

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” Alexander explained. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”

Dr. Alexander makes a great point: Just because a drug is approved by the FDA, doesn’t mean it’s safe. In an ideal world, FDA approval would mean that the drug is entirely safe to use, but the reality is that the testing is not extensive enough to even determine the safety of the drug, let alone guarantee it.

Far too often, people place their doctors and health care practitioners on pedestals and fail to conduct their own research. Though I am not qualified to professionally advise anyone on their health, I certainly do not trust everything that my doctor recommends, which is largely because no doctor knows everything there is to know about health. It’s up to you to figure out your own health, not your doctor.

Though doctors can provide wonderful advice and can help immensely when diagnosing and treating illnesses, they can also drastically hinder your health. However, that’s not necessarily their fault, it’s often yours. The onus is on you to conduct your own research, get multiple professional opinions if need be, and ensure you are making informed decisions.

Further Proof of Misconduct at the FDA

In journalism, embargo refers to a “back-room deal” in which journalists and their sources agree not to publish an article prior to a specific date or time. The FDA goes one step further by implementing a “closely held embargo,” which gifts the organization complete control over all new FDA information privy to exposure for the American public.

The FDA’s use of the “close embargo” reveals that the institution likely wants to prevent reporters from leaking information. The biggest concern seems to be that, when officials begin giving the go-ahead for this special access, it makes it much easier for the agency to prevent stories they don’t like from being exposed.

The FDA hinders the public’s right to know about scientific fraud and misconduct as well. In an article for Slate wrote:

For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

You can read more about that in the following CE article:

FOIA Investigation Unearths Documents Showing How The FDA  Manipulates Media & Science Press

The FDA also works hand-in-hand with pharmaceutical companies, which you can read about in the following CE article:

Merck & The FDA Caught ‘Fast Tracking’ The Approval Of HPV Gardasil Vaccine Without Scientific Approval

To make matters worse, pharmaceutical companies also hold close ties to doctors, which you can learn about here:

This Website Tells You How Much Big Pharma Pays Your Doctor To Prescribe Drugs

To be clear, 128,000 people die every year in the U.S. from drugs prescribed to them, which is being done under the approval of the FDA and doctors. The reality is, drug companies make a lot of money from selling prescriptions, and so do those involved with them, including doctors.

At the end of the day, the medical industry is a booming business, one that thrives off sick people. These companies actually benefit when their drugs cause adverse effects, because they then have additional reasons to sell you even more drugs. The system is designed to help you in one way, and then disadvantage you in another. In essence, they want you healthy, but not too healthy, and until we educate ourselves and take control of our health, we will continue to perpetuate this cycle.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Alternative News

Norway Investigates 29 Deaths in Elderly Patients After Pfizer Covid-19 Vaccination

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In Brief

  • The Facts:

    Norway has registered a total of 29 deaths among people over the age of 75 who’ve had their first Covid-19 vaccination shot, raising questions over which groups to target in national inoculation programs.

  • Reflect On:

    Should freedom of choice always remain here? Should governments and private institutions not be allowed to mandate this vaccine in order to have access to certain rights and freedoms?

What Happened: 29 patients who were quite old and frail have died following their first dose of the Pfizer COVID-19 vaccination. As a result, Norwegian officials have since adjusted their advice on who should get the COVID-19 vaccine.

This doesn’t come as a surprise to many given the fact that the clinical trials were conducted with people who are healthy. Older and sick people with co-morbidities were not used in the trials, and people with severe allergies and other diseases that can make one more susceptible to vaccine injury were not used either. It can be confusing given the fact that vaccination is being encouraged for the elderly in nursing homes and those who are more vulnerable to COVID-19.

Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told the British Medical Journal (BMJ) that “There is no certain connection between these deaths and the vaccine.”

On the 15th of January it was 23 deaths, Bloomberg is now reporting that a total of 29 deaths among people over the age of 75 who’ve had their first COVID-19 shot. They point out that “Until Friday, Pfizer/BioNTech was the only vaccine available in Norway”, stating that the Norwegian Medicines Agency told them that as a result “all deaths are thus linked to this vaccine.”

“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said. All the reported deaths related to “elderly people with serious basic disorders,” it said. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”

Madsen also told the BMJ that,

There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly. We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease. We are not asking for doctors to continue with vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

The BMJ article goes on to point out that the Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after COVID-19 vaccination, and closes with the following information:

In a statement, Pfizer said, “Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2. We are working with NOMA to gather all the relevant information.

“Norwegian authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirm the number of incidents so far is not alarming, and in line with expectations. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take the patients’ health into more consideration.

“Our immediate thoughts are with the bereaved families.”

Vaccine Hesitancy is Growing Among Healthcare Workers: Vaccine hesitancy is growing all over the globe, one of the latest examples comes from Riverside County, California. It has a population of approximately 2.4 million, and about 50 percent of healthcare workers in the county are refusing to take the COVID-19 vaccine despite the fact that they have top priority and access to it.  At Providence Holy Cross Medical Center in Mission Hills, one in five frontline nurses and doctors have declined the shot. Roughly 20% to 40% of L.A. County’s frontline workers who were offered the vaccine did the same, according to county public health officials. You can read more about that story here.

Vaccine hesitancy among physicians and academics is nothing new. To illustrate this I often point to a conference held at the end of 2019 put on by the World Health Organization (WHO). At the conference, Dr. Heidi Larson a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project Emphasized this point, having  stated,

The other thing that’s a trend, and an issue, is not just confidence in providers but confidence of health care providers. We have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day any study I’ve seen…still, the most trusted person on any study I’ve seen globally is the health care provider.

A study published in the journal EbioMedicine  as far back as 2013 outlines this point, among many others.

Pfizer’s Questionable History:  Losing faith in “big pharma” does not come without good reason. For example, in 2010 Robert G. Evans, PhD, Centre for Health Services and Policy Research Emeritus Professor, Vancouver School of Economics, UBC, published a paper that’s accessible in PubMed titled “Tough on Crime? Pfizer and the CIHR.”

In it, he outlines the fact that,

Pfizer has been a “habitual offender,” persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. Since 2002 the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards. The 2.3-billion settlement…set a new record for both criminal fines and total penalties. A link with Pfizer might well advance the commercialization of Canadian research.

Suppressing clinical trial results is something I’ve come across multiple times with several different medicines. Five years ago I wrote about how big pharma did not share adverse reactions people had and harmful results from their clinical trials for commonly used antidepressant drugs.

Even scientists from within federal these health regulatory agencies have been sounding the alarm. For example, a few years ago more than a dozen scientists from within the CDC put out an anonymous public statement detailing the influence corporations have on government policies. They were referred to as the  Spider Papers.

The Takeaway: Given the fact that everything is not black and white, especially when it comes to vaccine safety, do we really want to give government health agencies and/or private institutions the right to enforce mandatory vaccination requirements when their efficacy have been called into question? Should people have the freedom of choice? It’s a subject that has many people polarized in their beliefs, but at the end of the day the sharing of information, opinion and evidence should not be shut down, discouraged, ridiculed or censored.

In a day and age where more people are starting to see our planet in a completely different light, one which has more and more questioning the human experience and why we live the way we do it seems the ‘crack down’ on free thought gets tighter and tighter. Do we really want to live in a world where we lose the right to choose what we do with our own body, or one where certain rights and freedoms are taken away if we don’t comply? The next question is, what do we do about it? Those who are in a position to enforce these measures must, it seems, have a shift in consciousness and refuse to implement them. There doesn’t seem to be a clear cut answer, but there is no doubt that we are currently going through that possible process, we are living in it.

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Psycho-Acoustic Medicine: Science Behind Sound Healing For Serotonin Production

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In Brief

  • The Facts:

    A number of studies and experiments have shown that sound can be used as medicine for various ailments and diseases.

  • Reflect On:

    Is our modern day medical industry truly interested in the health and well-being of people, or do profit and control take more priority?

Mental illness has reached an all time high in the world, and yet the modern day medicines to relieve symptoms have gained controversy. This is, in part, why people have dug up the past to better understand alternative ways of healing.

Sound, for instance, has been a tool for promoting the physical and emotional health of the body for as long as history can account for, deeply rooted in ancient cultures and civilizations. The ancient Egyptians used vowel sound chants in healing because they believed vowels were sacred. Tibetan monks take advantage of singing bowls, which they believe to be “a symbol of the unknowable” whose “vibrations have been described as the sound of the universe manifesting.”

“Our various states of consciousness are directly connected to the ever-changing electrical, chemical, and architectural environment of the brain. Daily habits of behavior and thought processes have the ability to alter the architecture of brain structure and connectivity, as well as, the neurochemical and electrical neural oscillations of your mind.”

Psychoacoustics is the scientific study of the perception of sound, and it has fueled researchers paths to better understand how it can be used as medicine. For instance, in 1973, Dr. Gerald Oster, a medical doctor and biophysicist, proved, in his research paper, “Auditory Beats in the Brain,” how sound affects the how the brain absorbs new information, controls mood, sleep patterns, healing responses, and more, and how quickly. Thus, specific frequencies of sound and music can be used to generate neurotransmitters such as serotonin.

brain_scan

To understand the fundamentals of sound in healing, we must first understand our brain waves. The nucleus of our thoughts, emotions, and behaviors, is the communication between neurons. Brain waves are generated by way of electrical pulses working in unison from masses of neurons interacting with one another. Brain waves are divided into five different bandwidths that are thought to form a spectrum of human consciousness.

The slowest of the waves are delta waves (.5 to 3 Hz), which are the slowest brain waves and occur mostly during our deepest state of sleep. The fastest of the waves are gamma waves (25 to 100 Hz), which are associated with higher states of conscious perception. Alpha waves (8 to 12 Hz) occur when the brain is daydreaming or consciously practicing mindfulness or meditation.

According to Dr. Suzanne Evans Morris, Ph.D., a speech-language pathologist:

Research shows that different frequencies presented to each ear through stereo headphones… create a difference tone (or binaural beat) as the brain puts together the two tones it actually hears. Through EEG monitoring the difference tone is identified by a change in the electrical pattern produced by the brain. For example, frequencies of 200 Hz and 210 Hz produce a binaural beat frequency of 10 Hz (The difference in 210 Hz and 200 Hz is 10 Hz). Monitoring of the brain’s electricity (EEG) shows that the brain produces increased 10 Hz activity with equal frequency and amplitude of the wave form in both hemispheres of the brain (left and right hemisphere).

It is thought that different brain wave patterns are connected to the production in the brain of certain neurochemicals linked with relaxation and stress release, as well as better learning and creativity, memory, and more. Such neurochemicals include beta-endorphins, growth factors, gut peptides, acetylcholine, vasopressin, and serotonin.

A series of experiments conducted by neuro-electric therapy engineer Dr. Margaret Patterson and Dr. Ifor Capel, revealed how alpha brainwaves boosted the production of serotonin. Dr. Capel explained:

As far as we can tell, each brain center generates impulses at a specific frequency based on the predominant neurotransmitter it secretes. In other words, the brain’s internal communication system—its language, is based on frequency… Presumably, when we send in waves of electrical energy at, say, 10 Hz, certain cells in the lower brain stem will respond because they normally fire within that frequency range.

Additional research upholds the beliefs of mind-body medicine in this sense, stating that brainwaves being in the Alpha state, 8 to 14 Hz, permits a vibration allowing for more serotonin to be created.

It’s important for us to come to terms with the fact that there is science behind age-old medicinal practices that do not require putting unknown substances in our bodies to alleviate issues like stress, depression, anxiety, and more.

But even more intriguing is to think something as simple as sound, as music, which we have come to treat as utterly pleasurable entertainment, has not only been used to promote healing and well-being, but has proven to work through research as well.

If your mental health is of concern, try listening to a binaural beat to generate alpha waves between 8 and 14 Hz to produce more serotonin. Another option is to take advantage of music that promotes a relaxed alpha state in the brain such as classical music.

Related CE Article: Research Shows We Can Heal With Vibration, Frequency & Sound

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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Awareness

Study: Short Break From Cosmetics Causes “Significant Drop of Hormone Disrupting Chemicals”

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In Brief

  • The Facts:

    A study led by researchers at UC Berkeley and Clinica de Salud del Valle de Salinas demonstrates how even a short break from certain kinds of makeup, shampoos and lotions leads to a large drop in levels of hormone-disrupting chemicals in the body.

  • Reflect On:

    Why is this industry so poorly regulated?

A study led by researchers at UC Berkeley and Clinica de Salud del Valle Salinas has demonstrated how taking even a short break from various cosmetics, shampoos, and other personal care products can lead to a substantial drop in the levels of hormone-disrupting chemicals present within the body.

The results from the study were published in the journal Environmental Health Perspectives. Researchers gave 100 Latina teenagers various personal care products that were labeled to be free of common chemicals including phthalates, parabens, triclosan, and oxybenzone. These chemicals are used regularly in almost all conventional personal care products such as cosmetics, soap, sunscreen, shampoo, conditioner, and other hair products, and animal studies have shown that they directly interfere with the body’s endocrine system.

“Because women are the primary consumers of many personal care products, they may be disproportionately exposed to these chemicals,” said study lead author Kim Harley, associate director of the UC Berkeley Center for Environmental Research and Children’s Health. “Teen girls may be at particular risk since it’s a time of rapid reproductive development, and research has suggested that they use more personal care products per day than the average adult woman.”

Results

After just a three-day trial with the girls using only the lower-chemical products, urine samples showed a significant drop in the level of chemicals in the body. Methyl and propyl parabens, commonly used as preservatives in cosmetics, dropped 44% and 45%, respectively, metabolites of diethyl phthalate, used often in perfumes, dropped by 27%, and both triclosan and benzophenone-3 fell 36%. The authors of the study were surprised to see an increase in two lesser common parabens, but, being minor, could easily have been caused by accidental contamination or a substitute not listed on the labels.

Co-director of the study Kimberly Parra explains why having local youths participate in the study was of particular importance:

The results of the study are particularly interesting on a scientific level, but the fact that high school students led the study set a new path to engaging youth to learn about science and how it can be used to improve the health of their communities. After learning of the results, the youth took it upon themselves to educate friends and community members, and presented their cause to legislatures in Sacramento.

Included in the CHAMACOS Youth Council were 12 local high school students who helped design and implement the study. One of the teen researchers, Maritza Cárdenas, is now a UC Berkeley undergraduate majoring in molecular and cell biology.

“One of the goals of our study was to create awareness among the participants of the chemicals found in everyday products, to help make people more conscious about what they’re using,” said Cárdenas. “Seeing the drop in chemical levels after just three days shows that simple actions can be taken, such as choosing products with fewer chemicals, and make a difference.”

The researchers noted that cosmetics and personal care products are not well-regulated in this country, and that getting data about health effects from exposure, particularly long-term ones, is difficult. But they say there is growing evidence linking endocrine-disrupting chemicals to neurobehavioral problems, obesity and cancer cell growth.

What Can You Do?

Well, you can be sure to check the labels on any products you purchase. Most personal care products contain a list of ingredients, but unfortunately many cosmetics do not. If you use a particular brand that you really love you can try contacting the manufacturer directly and asking them for an ingredient list.

You can also opt for more natural and organic products, but be sure to keep in mind that in the industry of personal care products, the words “natural” and “organic” are often meaningless. A safe bet would be to buy these products from a health food store and be sure to read the ingredients or ask the sales clerk. Generally, when products do not contain specific chemicals, the manufacturers are happy to label them as such.

The less demand for these chemically-laden products there is, the less these chemicals will be used. I’ve said it before and I’ll say it again: VOTE WITH YOUR DOLLAR! We have the power to create the type of world we want. Be the change.

Check out The Story Of Cosmetics below!

Dive Deeper

These days, it’s not just knowing information and facts that will create change, it’s changing ourselves, how we go about communicating, and re-assessing the underlying stories, ideas and beliefs that form our world. We have to practice these things if we truly want to change. At Collective Evolution and CETV, this is a big part of our mission.

Amongst 100's of hours of exclusive content, we have recently completed two short courses to help you become an effective changemaker, one called Profound Realization and the other called How To Do An Effective Media Detox.

Join CETV, engage with these courses and more here!

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