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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.

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A shocking 71 of the 222 drugs approved within this timeframe were withdrawn, had a “black box” warning regarding the side effects, or required a safety announcement to the public about newfound risks.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.

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Awareness

Johnson & Johnson Found To Have Knowingly Allowed Asbestos In Their Baby Powder

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In Brief

  • The Facts:

    Johnson and Johnson have recently lost lawsuits for negligence in knowingly allowing carcinogenic substances in their talc-based hygiene products.

  • Reflect On:

    Are we starting to turn the page on an era where human health and safety are not the prime considerations in the manufacturing of consumer products?

We are starting to awaken to the fact that it seems to be the rule, and not the exception, that large Western corporations put profits above human health considerations. The only time they seem to give any regard to human health concerns is when their forecasts of potential lawsuits down the road would likely exceed the cost measures needed to ensure the safety of their product.

Johnson & Johnson is just one of a long line of corporate perpetrators who believed that covering up and lying about known health concerns would make better business sense than taking the time and resources to actually address those health concerns within their products.

Contaminated Baby Powder: The Height Of Indignity

One would think, regardless of an understanding that the bottom line is a priority for most private companies, that the health and safety of a nursing mother and her newborn child would be sacrosanct for any industry. The reality is that this is simply not the case, even though J&J could have mitigated this problem from the start.

Companies that mine talc are required to take extra steps to ensure the absence of asbestos in their talc. Instead, J&J allegedly went to great lengths to fake it.

Not only did the company know about the asbestos contamination, evidence suggests, but J&J also failed to warn its customers about the link between Baby Powder and cancer or replace its talc with a safer alternative. As a result, J&J guaranteed its customers’ exposure to asbestos.

And regardless of their size or numbers, asbestos fibers are lethal at any capacity. As the World Health Organization (WHO) has stressed repeatedly, there is no safe level of exposure. (source)

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The Testimony of Scientist James Webber

Baby Powder’s contamination with asbestos (a mineral that naturally occurs near talc) has long been the subject of lawsuits. But only in recent years has evidence begun to unravel J&J’s defense – that the company had no idea – and threatened its success in lawsuits to come.

In March, a California jury awarded $29 million to Terry Leavitt, a woman who said that asbestos in Johnson & Johnson’s talcum-powder-based products caused her terminal mesothelioma. Environmental scientist James Webber testified in her high-profile California trial and made these observations:

During several hours on the stand, Webber explained how he ran tests that showed “clear” evidence of asbestos contamination in the mines from which J&J sourced talc.

“The testing I have seen [shows] that it was present at least as early as 1971 and up through the late 1990s,” said Webber, who ran an asbestos laboratory in New York state.

Despite denying it publicly, J&J had observed this contamination in internal memos. Its notes dismissed the amount of asbestos in its talc as “but a trace,” Webber alleged. But that was just an optimistic interpretation of superficial testing, he said: the tests used methods too weak to detect microscopic asbestos fibers. Webber insisted the actual tests results revealed there could be millions of asbestos fibers per gram of talc.

And J&J’s inaccurate reports were allegedly only the tip of the iceberg. In some instances, Webber said, photos attached to J&J’s reports revealed that “they had been seeing it and not reporting it.”  (source)

And It’s Getting Worse

The $29 million verdict, in California Superior Court in Oakland, was the latest defeat for the healthcare conglomerate facing more than 13,000 talc-related lawsuits nationwide. And things may be getting even worse for J&J, according to ZeroHedge:

Johnson & Johnson shares are down over 5% after Bloomberg reports that, according to people with knowledge of the matter, the U.S. Justice Department is pursuing a criminal investigation into whether Johnson & Johnson lied to the public about the possible cancer risks of its talcum powder…

Now, a grand jury in Washington is examining documents related to what company officials knew about any carcinogens in their products, the people said.

The Takeaway

It seems as though corporations have long been willing to take the calculated risk of short-cuts and denials instead of ensuring that their products are safe for public use. My suspicion is that a part of our collective awakening process will be issuing in a new business paradigm in which human health and safety become paramount.

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Awareness

Prescription Infant Formulas Found To Be Contaminated With Aluminum

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In Brief

  • The Facts:

    Multiple brands of prescription infant formula were found to contain high levels of aluminum.

  • Reflect On:

    Should we be questioning the quality of products that come from pharmaceutical production? Do we veer away from natural methods of raising children more than we should? At what cost?

You may not think aluminum is a big deal, but it is. For anybody who has looked into aluminum toxicology, it’s quite clear and apparent that it has no place inside of any living biological organism. Putting it simply, it wreaks havoc on our biology. High amounts of aluminum have been found in the brains of people with Alzheimer’s disease, with experts in the field believing that aluminum brain accumulation may be one of the main causes of Alzheimer’s disease.

It’s also been discovered within the brains of MS patients, and some of the highest aluminum content ever recorded in brain tissue has also been discovered in people with autism. Aluminum is associated with several diseases. But an adult body can do a great job of flushing out aluminum.

Despite the fact that aluminum has no place within earth’s biota, it’s still present in many of our medications, our food, and even in the water that we drink due to contamination since the industrial revolution. Aluminum inside the body is a new phenomenon and still understudied. Again, there is a threshold, and aluminum that is injected via vaccines doesn’t exit the body–there is strong evidence that it remains inside the body and ends up in distant organs and eventually inside of the brain. If you want to access more studies on that topic, you can read this article I published that provides them and goes into more detail. You can also watch this interview with Christopher Exley, where he also points to that fact.

A new study published in the International Journal of Environmental Research and Public Health has shown that multiple popular infant prescriptions are contaminated with aluminum. You may be asking how much aluminum, but the authors make it a point to stress that there are no safe amounts of aluminum levels that can be inside of a human body, let alone a newborn baby. That being said, the amounts found are listed within the abstract of the study:

Historical and recent data demonstrate that off-the-shelf infant formulas are heavily contaminated with aluminium. The origin of this contamination remains to be elucidated though may be imported via ingredients, packaging and processing. Specialised infant formulas exist to address health issues, such as low birth weight, allergy or intolerance and medical conditions, such as renal insufficiency. The aluminium content of these prescription infant formulas is measured here for the first time. We obtained 24 prescription infant formulas through a paediatric clinic and measured their total aluminium content by transversely heated graphite furnace atomic absorption spectrometry following microwave assisted acid/peroxide digestion. The aluminium content of ready-to-drink formulas ranged from 49.9 (33.7) to 1956.3 (111.0) μg/L. The most heavily contaminated products were those designed as nutritional supplements for infants struggling to gain weight. The aluminium content of powdered formulas ranged from 0.27 (0.04) to 3.27 (0.19) μg/g. The most heavily contaminated products tended to be those addressing allergies and intolerance. Prescription infant formulas are contaminated with aluminium.

Another very important point made right off the bat by the authors:

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Human exposure to aluminium is a serious health concern. Aluminium exposure in infants is understandably a burgeoning issue. While infant exposure to aluminium continues to be documented, its consequences, immediate and in the future, have received only scant attention and research is required to understand the biological availability of aluminium through formula feeding. For example, how much aluminium is absorbed across the neonate gut and its subsequent fate, including excretion.

There is already too much aluminium in infant formulas and herein we have measured its content in a large number of prescription formulas, products which are fed to vulnerable infants in their first months of life. Many of these products are heavily contaminated with aluminium.

As for the specific infant formulas, you can refer to the study. The researchers obtained 24 prescription infant formulas via the Paediatric Clinic of Russells Hall Hospital in Dudley, United Kingdom. The ready-to-drink and powdered products were new, ready-to-be used and unopened samples. These formulas are for babies with some sort of growth restriction, like for preterm infants or infants who have poor weight gain. There were also powdered formulas for allergies and intolerances and powdered formulas with additional amino acids.

The authors contacted each manufacturer and expressed that they denied knowing that there was any aluminum in their products, which means it’s still a mystery as to their source. The authors hypothesize on a number of ways that aluminum could be entering into the formulas.

In their conclusion, the authors emphasize that:

Where possible, breast milk feeding should be prioritised, as the aluminium content of breast milk is invariably an order of magnitude lower than in formula feeds. Where infant formulas are the only source of nutrition for many infants in their first weeks and months of life, aluminium ingested in formula feeds will be the major contributor to their body burden of aluminium. The last thing that vulnerable infants fed specialised formulas for their specific nutritional/medicinal need is additional aluminium in their diet.

Detoxing

There is a lot of information out there on how a person can detox from aluminum and other heavy metals. There are multiple studies, and based on what I’ve looked into, water with high amounts of Silica are effective in draining aluminum out of your body and brain. Herbs like cilantro and substances like chlorella and spirulina are also great for removing some metals. The information is out there, so be sure to do your research.

The Takeaway

It’s concerning to think about what these corporations are doing. Again, aluminum should hold no place in our society, it should’ve remained well below our surface as part of the Earth’s crust for a reason. It wasn’t until humans began digging it out and using it for a number of things, irresponsibly I might add, that we started to see the health implications which still go largely ignored by the medical community.

In fact, heavy metal accumulation and detoxification of aluminum haven’t been addressed at all, which is odd given the fact that heavy metal accumulation is linked to a variety of diseases.

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Awareness

9 Studies You Should Be Aware of Before Trying The Ketogenic Diet

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In Brief

  • The Facts:

    The Ketogenic diet is a popular fad diet that promotes quick weight loss and symptom management for bodies that are dealing with poor lymph, kidney and digestion health.

  • Reflect On:

    Based on the studies that are emerging, is our desire for quick weight loss more important than living a long and healthy life? Are we learning about these diets primarily through those with strong ties to upholding these diets?

The ketogenic diet has popped up as a popular approach to weight loss in the last few years. Is it successful at that? Sure, it is. I’ve experimented with the diet myself years ago when I was looking to lose some belly fat. I was entering into ketosis in a different way than most, as I was not eating any animal products, but it does in fact work.

But like any animal product based diet, what are the consequences of eating so much food that does not truly jive with our human bodies? Not only that, is fast weight loss more important than keeping our morality rate down?

In the last few years, we’ve reported a lot on the Keto diet and the various ways it can be done. We have explored the studies, the results and in some ways, we supported it. But lately, I have been thinking about how supporting this could actually be encouraging people to jump into these diets, including the paleo diet, when in reality these diets increase mortality rates and are not healthy for the human body.

It became a thought in the back of my mind, I have always strived to put the best information out that I can through this platform to promote good health. And so we must look at that, even if that means upsetting some people who currently are on paleo or keto and are seeing some good weight loss or symptom management. The truth is, like the many people I’ve seen crash on these diets after a few years, I want people to know the truth of what’s going on out there. And how we can get beyond diets that symptom manage, and instead get onto diets that truly heal.

Anytime we have fad diets, which paleo and keto are, we see products and bias pop up all over the place to support the continuation of these trends. It becomes less about health and more about upholding an identity or a business.

So as I recently looked into what experts are saying about these diets, I came upon two important videos I think everyone should check out. Both have been embedded below. Remember, it’s not that I care what you choose in your own life, or that I feel there is a right or wrong, it’s that I believe we should be informed and I wish to use this platform to promote as best a message as I can.

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The Videos

Thanks to Plant-Based News for creating such a good channel and resource of information on YouTube.

In this video, several plant-based health experts talk through 9 nutrition studies that would be of interest to low carb keto diet proponents. To read the 9 studies, click here.

Next up, Dr. Kim Williams (past President of the American College of Cardiology) shares his insights about the ketogenic.

Related Articles

Diabetic Shares Why He Quit ‘The Ketogenic Diet’

Doctor Explains Why She Never Recommends The ‘Ketogenic Diet’

The Biggest Misconception About The ‘Ketogenic Diet’…You Don’t Actually Have To Follow It

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