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A shocking 71 of the 222 drugs approved within this timeframe were withdrawn, had a “black box” warning regarding the side effects, or required a safety announcement to the public about newfound risks.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

How To Clear Seriously Blocked Sinuses Naturally In 1 Minute

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In Brief

  • The Facts:

    Three simple steps you can take to clear blocked sinuses that seem to work for many people.

  • Reflect On:

    Are you healthy? What natural things do you do when "flu season" comes around to give your immune system a boost?

Having clogged sinuses isn’t fun. You can’t breath, you can’t smell, your head hurts, and your voice sounds funny. Finding relief when you have clogged sinuses is usually like finding a million dollars on the ground — it’s amazing!

The causes for nasal congestion can range greatly, and you don’t have to be sick to be congested. Many people will experience congestion from allergies, temperatures, dust, smoking, spicy food, and air particles.

Recently I was at Contact in the Desert in California and I found myself having clogged sinuses from the blowing sand and dry air. Within two days, I couldn’t breathe at all out of one side of my nose and my sinuses got blocked up, causing my face and head to hurt. I needed a solution.

After trying to blow my nose over and over again, I turned to the internet for relief. Sure enough, Google came through.

I found a video by Dr. Adam that quickly and easily explained how to clear sinuses in about one minute using just your fingers — and no, they don’t have to go in your nose. Sure enough, I had relief from the pain the blockage was causing, and I could breathe!

Some might be wondering why I didn’t take sinus or cold medication to get relief. The answer is simple: I don’t like taking medication for anything unless I absolutely have to. I know many of you are on the same page and like to do things naturally. Many cold medications just mask symptoms and come with negative side effects that are worth avoiding if possible.

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How to Clear Your Sinuses Fast!

You simply need to sit down and get your hands ready for the following steps. The video below offers a visual demonstration, so I recommend checking that out too.

1. While sitting with your head and body on about a 45 degree angle, turn your head sideways and rub your sternocleidomastoid muscle downward four or five times. You can find the muscle right beneath your ear running down your neck to your collarbone. See image. Do this on both sides of your neck to help relax your neck.

2. Take your index fingers, locate the hard, bony part of the upper sides of your nose, and move downward toward the soft part on the side of your nose where the bone ends. Begin massaging this area in a circular motion with as much pressure as you can for about 20 seconds. Once completed, rub the muscles from the side of your nose down and toward your cheekbones to relax them.

3. Take your index fingers and run them under the inside orbit bone above your eyes until you find a notch in the bone called the super orbital notch. It is usually just above the centre of the eye. Massage that notch in a circular motion with as much pressure as you can handle for about 20 seconds. Once done, massage your forward with both hands starting in the centre of your forehead and pulling outwards towards your temples.

That’s it! Once you have gone through this process you should notice a lot of relief in your sinuses and should be able to blow your nose quite easily. You may have to repeat this process again, but play with it and see what works for you.

Below is a video from Dr. Adam explaining the entire process. I have also included another helpful method that worked well for me as well.

Alternative Method

This method is simpler but may not be as effective for everyone. As always, do what works best for you.

1. Push your tongue flat into the roof of your mouth, with decent pressure, for one second.

2. Then, take your thumb and press the area right between your eyebrows above your nose for one second.

3. Alternate between steps one and two over and over again for about 20-30 seconds. Note: You are not pressing the points at the same time, simply alternating between them.

Repeat this process as necessary to help clear your sinuses.

Prevention

If you’ve had blocked sinuses, you probably don’t want it to happen often, so prevention is the key! Here are a few ways you can avoid blocked sinuses.

Eat a well-balanced diet – Eating healthy foods promotes good health. What you put into your body to digest is what determines your health. If you want your immune system working well, take care with quality food and keep your gut performing well.

Get regular exercise – Regular exercise also helps improve overall health and the immune system.

Quit smoking – It goes without saying, but cigarettes are not good for us and the smoke can irritate sinuses.

Use a humidifier – If you find your house dry, use a humidifier to help dampen the air. You can also hop in a warm shower and breathe in the steam. It’s best to use a chlorine filter on your shower head so you aren’t breathing in toxic chemicals from chlorine.

Cut out antibiotics – Antibiotics don’t do anything for viral infections, which is usually why people get clogged sinuses when they are sick. Antibiotics wreak havoc on your health. Only take them when they are absolutely necessary!

Keep a clean home – Dust and poor air quality can also cause blocked sinuses. Vacuum and wipe down surfaces of your home regularly. Decrease clutter and areas where dust can collect and stay.

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Alternative News

Cannabis Might Reverse Heart Failure, University of Hawaii Study Finds

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In Brief

  • The Facts:

    New research is showing that TRPV1, a cannabinoid receptor found abundantly in the heart may be key in slowing down and potentially even reversing heart failure.

  • Reflect On:

    With so many medical applications and the potential to treat and even cure a wide variety of diseases, why has there been such a lack of research, funding and clinical trials when it comes to medical marijuana?

Cannabis could potentially slow and even reverse heart failure via TRPV1, a cannabinoid receptor. This is according to research led by a team at the University of Hawaiʻi John A. Burns School of Medicine (JABSOM).  Alexander Stokes, a JABSOM assistant professor in cell and molecular biology, said “the potential medical benefits of using cannabis-based therapies for the treatment of heart disease are promising.”

TRPV1 is showing long-term effective reversal of heart failure when the substance is administered orally. The key here is orally, this doesn’t mean that you can smoke cannabis and it will be good for your heart, in fact, it may very well have a negative effect if you do that. “TRPV1 has primarily been studied as a pain receptor,” said Stokes. “The receptors are abundant in the heart, and we are excited to show that if we inhibit its function with oral doses of drugs, we can reverse some effects of heart failure.”

The findings were published in the journal Channels.

A Big Topic Right Now

The topic of medical marijuana is a big one right now, especially in Canada where it was recently legalized. For years, there’s been a negative stigma attached to the substance, and when one dives deep into the subject it’s quite easy to see why. Cannabis, often called marijuana, has potential to treat and possibly even cure a wide range of diseases, but because of prohibition, the studies examining the medicinal aspects of the herb have been very limited. This is very unfortunate, for a number of reasons, and also very suspicious.

If we look at cancer, for example, multiple studies have clearly shown its potential to completely destroy cancer cells, many in vitro studies have clearly demonstrated this potential, without question. They’re not hard to find and have been published in abundance. Here is a video of Dr. Christina Sanchez, a molecular biologist at Compultense University in Madrid, Spain, explaining how THC (the main psychoactive constituent of the cannabis plant) can completely kill cancer cells. THC is simply one constituent of cannabis. It has been shown to be effective for multiple diseases as well, while other diseases are better treated with CBD, another constituent within cannabis. This begs the question, why have there been no, or at least so few, clinical trials set up as a result?

This hasn’t stopped people taking matters into their own hands though. There are numerous examples all over the internet of people claiming that cannabis oil, for example, cured their cancer. But from a scientific perspective this isn’t evidence, it’s simply anecdotal and as a result of a lack of research we cannot officially say cannabis kills cancer. We can only say that it has tremendous potential and that a lot more research is needed.

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Pharma vs Cannabis

When a pharmaceutical drug shows even less than half of the potential that marijuana has shown, clinical trials are set up right away. Just imagine if the same resources that are poured into conventional cancer treatments were given to medical marijuana’s potential to treat cancer, among a wide range of other diseases. If that were to happen, we would know much more. But the lack of research continues. Is it because if scientists were to discover what strain, method of delivery and all of the other factors that require more research that are needed to treat disease, cannabis could become an effective treatment for cancer? What would happen to conventional treatments? Would people have to pay for their treatment if it was disclosed how to, for example, make cannabis oil in the right way for a specific cancer? Maybe this has something to do with it?

Big pharma would lose billions. It’s definitely something to think about.

What’s happening right now with the legalization of marijuana is that components of it are allowed to be studied. It seems that drugs will be developed to synthesize certain components of the plant, and the drugs themselves can then be patented. This is how big pharma will ultimately make money off of medical marijuana.

The Challenge With Government Control Of Cannabis

It’s great to see people with Parkinson’s, Dementia, Alzheimer’s disease, Epilepsy, cancer and more have tremendous success with medical marijuana. What’s unfortunate is that mainstream medical marijuana will be in the hands of big pharma, it already is. We will not know how it’s grown, how it’s been manipulated, and what’s been changed. It’s simply being used for profit, because at the end of the day that’s what it’s all about in our current infrastructure. We have a sick care industry, not a health care industry.

A free, open and caring society, a health care industry that truly cares about health could use multiple natural substances to completely wipe out the need for any pharmaceutical drug. There are massive amounts of foods, herbs and plants that, if studied in full, could completely eliminate our dependence on the corporation.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”

– Arnold Seymour Relman (1923-2014), Harvard professor of medicine and former Editor-in-Chief of The New England Medical Journal  (source)

Important Thoughts To Consider About Cannabis

The other side of the coin is that heavy cannabis use, although not lethal, can be dangerous and potentially damaging to young brains that are not fully developed, and perhaps to those who use it on a regular basis in ways we do not yet understand.

It’s not as harmful as alcohol abuse or smoking cigarettes, but there is still a lot that we don’t know. Legalization in Canada at least have led to the idea that it’s completely safe and beneficial for everybody. This is also, most likely, not true.  We need to get past the idea that it’s something healthy for everybody, and even healthy to smoke cannabis on a regular basis. But when it comes to the medicinal aspects of cannabis, for several diseases, there is a very serious discussion to be had here as it’s again, already helping many people around the world with their cancer, with their epilepsy, etc.

With many people losing trust in the medical industry, it’s easy to see why they are turning to growing their own cannabis, testing doses, and methods of delivery, etc. For some, it’s a shot in the dark but worth a try.

We are not advocating that it’s healthy to use cannabis recreationally and that it will not have any negative effects, we are simply stating that it’s a head scratcher how such a potent medical plant that clearly has multiple medical applications has been ignored and prohibited from research and professionally treating many diseases with it.

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Awareness

America’s Fifty-Fold Increase in Obsessive-Compulsive Disorder – What’s Going On?

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Obsessive-compulsive disorder (OCD), considered a neurobiological condition, is an often “long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions), and behaviors (compulsions) that he or she feels the urge to repeat over and over.” Although the specific obsessions and compulsions vary widely from person to person, the common denominator is that they “create stress and interfere with daily life.”

U.S. researchers estimate that OCD affects 1%-2% of children and up to 3% of adolescents and adults. The current lifetime prevalence estimate of around 2.7% is 54 times higher than the estimated pre-1980s prevalence (for the U.S. population as a whole) of around 0.05% (1 in 2000). In a retrospective hospital-based study that looked at OCD prevalence over time, researchers who examined psychiatric discharge diagnoses from 1969 to 1990 reported that something changed in the 1980s, with a marked increase in the frequency of OCD diagnoses over the decade.

Reflecting the disorder’s growing prominence, the American Psychiatric Association’s 2013 diagnostic manual revisions eliminated OCD as a subcategory of “anxiety disorders” and gave the diagnosis its own category of “obsessive-compulsive and related disorders.” OCD experts now urge busy neurologists “to be aware of OCD…and to have a high index of suspicion for this disorder.”

OCD is just one of numerous neurodevelopmental disorders that have gone from relatively rare to common since the late 1980s—over the same time frame in which the childhood vaccine schedule exploded. There are at least three reasons to suspect a potential vaccine-OCD link:

  1. Proper brain function depends on a well-regulated immune system.
  2. Vaccination’s acknowledged aim is to “perturb the immune system.”
  3. Immune dysregulation is a documented contributor to OCD and other neurodevelopmental disorders.

As Duke University researchers have stated, “the immune system, both in the central nervous system (CNS) and in the periphery, is crucial in shaping and influencing normal brain functions, and any disruption of immune function could adversely impact the brain too.”

Not only OCD

Studies show that OCD is more severe when it is early-onset; when diagnosed before puberty, children have “a longer duration of illness [and] higher rates of comorbid tics” as well as more frequent compulsions and greater psychosocial difficulties. In addition to comorbid tics, OCD often presents alongside autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD) and other diagnoses that are not only increasingly common in American children but often persist into adulthood. In a study of adults with OCD, three out of four (75%) had one or more other neuropsychiatric diagnoses. Researchers also believe that some types of OCD may be closely related to PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections).

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Compared to girls, boys tend toward a greater neuroinflammatory response, reflecting sex differences in how the brain’s principal immune cells (the microglia) function. This may be one of the reasons why early-onset OCD is two to three times more common in boys. (In early adulthood, however, OCD symptoms appear more frequently in women.) In this respect, OCD is no different from a number of other neurodevelopmental and health conditions, including ASD, that also disproportionately affect boys.

The Yale study

In 2017, researchers from the Yale Child Study Center published a retrospective case-control study in Frontiers in Psychiatry that considered a possible association between prior vaccination and increased incidence of seven neuropsychiatric disorders, including OCD. Recall that at the start of the 1980s, children received three vaccines for seven illnesses (totaling two dozen doses by age 18), whereas fully vaccinated children now get almost six dozen doses for sixteen conditions.

The Yale researchers looked at a national sample of privately insured children and adolescents (ages 6-15) for the six-year period from January 2002 through December 2007. They found that for four diagnoses—OCD, anorexia nervosa, anxiety disorder and tic disorder—the affected children were more likely than matched controls to have received a flu shot in the preceding 12 months. In addition:

  • For OCD, flu shots just three or six months prior also increased the risk.
  • There was an association between OCD and hepatitis A vaccination.
  • Children with OCD, anorexia or a tic disorder were more heavily vaccinated overall compared to children without these disorders.

All three vaccines marketed in the U.S. for hepatitis A—GlaxoSmithKline’s Havrix and Twinrix and Merck’s Vaqta—list anorexia as adverse reactions reported during clinical trials. The Yale authors considered the “high comorbidity rates” between OCD and anorexia significant and also highlighted that OCD and anorexia have a number of “immune-mediated mechanisms” in common.

OCD is also frequently comorbid with a variety of autoimmune diseases. A recent Swedish study reported that individuals with OCD had a 43% increased risk of any autoimmune disease (compared to those without OCD), and “significantly elevated” risks for autoimmune conditions “across all organ systems”:

  • Moisture-producing glands: Sjögren’s syndrome (94% increased risk)
  • Small intestine: Celiac disease (76%)
  • Peripheral nervous system: Guillain-Barré syndrome (71%)
  • Gastrointestinal tract: Crohn’s disease (66%)
  • Thyroid: Hashimoto’s thyroiditis (59%)
  • Pancreas: Type 1 diabetes mellitus (56%)
  • Platelets: Idiopathic thrombocytopenic purpura (51%)
  • Large intestine: Ulcerative colitis (41%)
  • Central nervous system: Multiple sclerosis (41%)
  • Skin: Psoriasis vulgaris (32%)

Beware the adjuvants

Given the extensive overlap between OCD and autoimmunity, the growing body of research that links vaccine adjuvants to autoimmunity is relevant for OCD. In fact, adjuvants—intended to intensify the immune response to a vaccine (immunogenicity)—present vaccine makers with a dilemma: “[I]ncreased vaccine reactogenicity [adverse reactions to vaccination] is the inevitable price for improved immunogenicity.”

Pointing to their influenza vaccination findings, the authors of the Yale study note that six European countries and China linked H1N1 influenza vaccination in 2009 to autoimmune narcolepsy, and some speculated that the H1N1 vaccine’s adjuvant—a squalene-based oil emulsion called AS03—was the culprit. Researchers caution:

A major recurring concern is the potential association between oil emulsion adjuvants and autoimmune disease induction as seen in animal and fish models. A single intradermal injection of a range of oil emulsions, including squalene emulsions, induces adjuvant arthritis in susceptible murine and rat models. […] There is a theoretical risk that any humans who share similar genetic susceptibility features to these models could similarly be prone to develop adjuvant arthritis, lupus, autoimmune hepatitis, uveitis or some other form of autoimmune disease after exposure to oil emulsion adjuvants alone or when combined with other potent innate immune activators [emphasis added].

Aluminum-based vaccine adjuvants—and especially the proprietary AAHS [amorphous aluminum hydroxyphosphate sulfate] adjuvant that Merck includes in its Gardasil 9, hepatitis A, hepatitis B and Haemophilus influenzae type b (Hib) vaccines—are also a prominent suspect in the autoimmunity epidemic. Researchers who compared AAHS to two other types of aluminum adjuvants found that AAHS was “substantially” different from the other two in revving up the immune system. As Italian researchers have stated, “the specific mechanism of action of each single adjuvant may have different effects on the course of different diseases.”

Hear no evil, see no evil

Pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs) is a “first-line” treatment for OCD; because remission is uncommon, “long-term management is often necessary.” Pfizer and GlaxoSmithKline—two of the four companies that lead the U.S. vaccine market—make some of the top-selling SSRIs prescribed for individuals with OCD; the two pharma behemoths completed a joint venture in 2019 to integrate their consumer health care businesses. From their point of view, OCD represents an attractive market.

Meanwhile, earlier this year, the federal government and the National Vaccine Injury Compensation Program turned down citizen requests to add asthma, autism, tics and several neuropsychiatric disorders—including PANDAS—to the Program’s Vaccine Injury Table. The feds’ refusal was not terribly surprising: very few new injuries have made it onto the Table since the Program came into being in 1986, despite the large number of vaccines piled onto the childhood schedule after that year. The government’s resolute refusal to conduct needed studies and its denial of even the possibility of vaccine culpability for conditions such as OCD leaves individuals no choice but to ferret out answers on their own.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

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