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Supreme Court Legislation Exempts Pharmaceutical Companies From Disclosing Risks Associated With Products

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“The learned intermediary doctrine is itself an exception to the manufacturer’s traditional duty to warn consumers directly of the risks associated with any product.”  (source)

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It’s called the “learned intermediary doctrine,” and it’s important to drug manufactures because it allows them to avoid warning consumers directly about their products when it comes to the risks associated with their use. Instead, these warnings are (supposedly) given to the physician, who lends their trust over to the corporation in the hopes that they are disclosing all information, who in turn is then responsible (the doctor) for relaying these risks to their patient. It takes all responsibility and liability (regarding risks associated with pharmaceutical products like vaccines and prescription drugs) away from the drug manufacturer, and places it solely on the physician.

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“Thus, prescription drug manufacturers’ duty to warn consumers flows through the patients’ prescribing physicians, not directly to consumers.” (source)

This is a scary thought, given the fact that the education doctors receive regarding all medicines comes directly from the drug manufactures themselves. Most of the time, doctors are educated on how the drug works to heal the patient and what biological processes take place with regards to the disease. In their own practices, some doctors accept the drugs without ever questioning their validity, giving complete trust over to the the pharmaceutical companies. Many doctors often assume that these drugs have passed through government safety checks by, for example, the Food and Drug Administration. It is still not properly acknowledged that pharmaceutical companies have a hand in dictating governmental policy, or that there are monetary incentives offered for dishonesty, especially when it comes to the health industry.

This is not just conspiracy theory, there are countless examples that clearly show why we cannot trust pharmaceutical companies to properly relay information regarding the risks associated with their products to doctors or to people who use their products and don’t require a doctor’s visit. I am talking about scientific fraud.

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine” (considered to be one of the most prestigious peer-reviewed medical journals in the world). – Dr Marcia Angell, Physician, Author, Former Editor in Chief of the NEJM (source)

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Documents obtained by Lucija Tomljenovic, PhD, from the Neural Dynamics Research Group in the Department of Ophthalmology and Visual Sciences at the University of British Columbia,ddd reveal that vaccine manufacturers, pharmaceutical companies, and health authorities have known about multiple dangers associated with vaccines but chose to withhold them from the public. This is scientific fraud, and suggests that this practice continues today. (source)

This is no secret. The list literally goes on and on, with many examples to choose from. And again, the law states that relaying the risks associated with these drugs are the doctors’ responsibility.

“For prescription drug manufacturers, the rationale behind the doctrine is based largely on the fact that prescription drugs’ actions are complex and the prescribing physician is the one best able to determine the drug’s potential benefits and risks for a particular patient.” Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 191 (Tex. 2004) (stating that the doctrine is based on the idea “that it is better for the patient for the warning to come from his or her physician”); Restatement (Third) of Torts: Prods. Liab. § 6(d)(1) cmt. b (1998) (“The rationale supporting this ‘learned intermediary’ rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy.’)” (source)

There are also exceptions to this law, where pharmaceutical companies provide health products directly to the consumer. In this case, they do not have to go through a physician. Examples include contraceptive pills, vaccines, and more.

“Modern realities have rendered the learned intermediary doctrine obsolete because its application allows pharmaceutical manufacturers to escape their traditional duty to warn at the expense of consumer health and well-being.” (source)

One example is the polio vaccine, where a (1968) court held that manufacturers of the polio vaccine had an obligation to warn patients directly of the fatal risks that are associated with vaccination. This is a great example where there was little to no physician supervision (still common today) when it comes to mass immunization clinics. In this case, the learned intermediary doctrine was inapplicable to drugs being directly marketed to consumers. Reasons include:

  • Informed consent requires a patient-based decision rather than the paternalistic approach of a bygone era
  • Many of the drugs marketed directly to consumers are lifestyle drugs that are not medically necessary, so it is not the physician weighing the risks and benefits but rather the patients
  • Drug manufacturers are already spending billions on advertising to consumers, so it is clear that they have effective means of communicating with consumers.

Why Are Pharmaceutical Companies Above The Law? Why Are They Constantly Exempt From Any Wrongdoing? 

What we are looking at here are measures put in place that completely protect pharmaceutical companies. Another great example is The National Childhood Vaccine Injury Act.

The mid-1970’s saw an increased focus on personal health, and accordingly, more people became concerned about vaccine safety. Several lawsuits were filed against vaccine manufacturers and healthcare providers by people who believed they had been injured by vaccines, and the evidence presented in court was good enough to win.

As a result, this act was developed to protect any pharmaceutical company, doctor, or medical association from any “fault.” It’s not about pointing fingers, many people really do believe that every vaccine is fine to inject into somebody. Instead of suing the vaccine manufacturer directly, parents have to undergo complex legal proceedings, asking the government to admit that the vaccine was responsible for their child’s injury and asking for compensation for the child’s care.

Pharmaceutical companies are exempt from participating in these proceedings, and tax payers are the ones who pay for all the vaccine-related damages, of which there have been many. Below is a great video explaining the process in detail. You can learn more about that here.

Again, ask yourself – why are so many laws, mandates, and programs put in place to completely protect pharmaceutical companies from any wrongdoing whatsoever? Think about that for a moment.

Sources:

http://www.burgsimpson.com/pdf/AbarayKernArticle.pdf

http://apps.americanbar.org/litigation/committees/products/articles/summer2013-0713-inside-learned-intermediary-doctrine.html

https://mckinneylaw.iu.edu/ilr/pdf/vol40p397.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964337/

http://nsnbc.me/wp-content/uploads/2013/05/BSEM-2011.pdf

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Abductions & Car Vandalism – Startling Australian UFO Report Unclassified

Gautam Peddada

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An uncovered Australian report performed by their Department of Defence. “Scientific Intelligence — General — Unidentified Flying Objects” is trending again. Those who have done extensive research on UFOs will find the Australian version of disclosure to be far more intellectually honest than the American version. Albeit it was conducted decades ago.

According to ex-US intelligence official Luis Elizondo, the Defense Department’s Inspector General is presently conducting three reviews. The inquiries vary from the Department of Defense’s handling of UFO claims to Elizondo’s alleged whistleblower retribution. The open IG cases are crucial to Australia’s report because they establish beyond a shadow of a doubt that the US Department of Defense is being dishonest and shady when it comes to the UFO subject. For decades, Australia has been a loyal friend of the United States. Within Australia’s boundaries, they share a military installation (Pine Gap). When a close defense ally’s intelligence agencies determined that the US was not being intellectually honest in its approach, perhaps it is reasonable to conclude that there is more to the tale than the 144 incidents studied since 2004 by the UAPTF.

The CIA became alarmed at the overloading of military communications during the mass sightings of 1952 and considered the possibility that the USSR may take advantage of such a situation.

Australian UFO study.

According to the summary, OSI, acting through the Robertson-Panel, encouraged the USAF to use Project Blue Book to publicly “debunk” UFOs. In a tragic twist of fate, when Australian authorities sought explanations from the US Air Force, the allegation was debunked. The authors of the study were depicted as conspiratorial and even crazy by the US Air Force. Ross Coulthart reported this, and it may be heard in a recent Project Unity interview. Courthart is an award-winning investigative journalist who is drawn to forbidden subjects. He also stated on the same podcast that a senior US Navy official identified as Nat Kobitz told him that the US had been in the midst of reverse-engineering numerous non-human craft. According to his obituary, Mr. Kobitz was a former Director of Research and Development at Naval Sea Systems Command.

Continue reading the entire article at The Pulse. 

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PGA Tour To End COVID Testing For Both Vaccinated & Non-Vaccinated Players

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CE Staff Writer 4 minute read

In Brief

  • The Facts:

    The PGA Tour has announced that it will stop testing players every week, regardless of whether they have been vaccinated or not.

  • Reflect On:

    Are PCR tests appropriate to identify infectious people? Should people who are healthy and not sick be tested at all, anywhere?

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The picture you see above is of John Rahm, a professional golfer on the PGA tour being carted off the golf course after tournament officials told him he had COVID. He was healthy and had no symptoms, yet was forced to withdraw from the tournament. He was told in front of the camera’s, and a big scene was made out of the event. You would think something like that, especially when you are a big time sports figure, would be done behind closed doors with some privacy.

Earlier on in June a spokesperson for the PGA Tour said that more than 50 percent of players on the PGA tour have been vaccinated. Although it seems that the majority of players on the tour will be fully vaccinated judging by this statement, it does leave a fairly large minority who won’t be, and that’s something we’re seeing across the globe as COVID vaccine hesitancy remains high for multiple reasons.

We are pleased to announce, after consultation with PGA Tour medical advisors, that due to the high rate of vaccination among all constituents on the PGA Tour, as well as other positively trending factors across the country, testing for COVID-19 will no longer be required as a condition of competition beginning with the 3M Open. – PGA tour Senior VP Tyler Dennis

The tour recently announced that the testing of players every week will stop starting in July for both the vaccinated and the unvaccinated. This was an unexpected announcement given the fact that, at least it seems in some countries, vaccinated individuals will enjoy previous rights and freedoms that everyone did before the pandemic. Travelling without need to quarantine and possibly in the future not having to be tested could be a few of those privileges. Others may include attending concerts, sporting events, or perhaps even keeping their job depending on whether or not their employer deems it to be mandatory, if that’s even legally possible. We will see what happens.

Luckily for professional golfers, regardless of their vaccination status they won’t have to worry about testing positive for COVID, especially if they’re not sick. This is the appropriate move by the PGA tour, who is represented by their players and it’s a move that the players themselves may have had a say in. It’s important because PCR tests are not designed nor are they appropriate for identifying infectious people. A number of scientists have been emphasizing this since the beginning of the pandemic. More recently, a letter to the editor published in the Journal of infection explain why more than half of al “positive” PCR tests are likely to have been people who are not infectious, otherwise known as “false positives.”

This is why the Swedish Public Health agency has a notice on their website explaining how and why polymerase chain reaction (PCR) tests are not useful for determining if someone is infected with COVID or if someone can transmit it to others, and it’s better to use someone who is actually showing symptoms as a judgement call of whether or not they could be infected or free from infection.

PCR tests using a high cycle threshold are extremely sensitive. An article published in the journal Clinical Infectious Diseases found that among positive PCR samples with a cycle count over 35, only 3 percent of the samples showed viral replication. This can be interpreted as, if someone tests positive via PCR when a Ct of 35 or higher is used, the probability that said person is actually infected is less than 3%, and the probability that said result is a false positive is 97 percent. This begs the question, why has Manitoba, Canada, for example, using cycle thresholds of up to 45 to identify “positive” people?

When it comes to golf, the fact that spread occurring in an outdoor setting is highly unlikely could have been a factor, but it’s also important to mention that asymptomatic spread within one’s own household is also considerably rare. It really makes you wonder what’s going on here, doesn’t it?

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New Study Questions The Safety of COVID Vaccinations & Urges Governments To Take Notice

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CE Staff Writer 9 minute read

In Brief

  • The Facts:

    A new study published in the journal Vaccines has called into question the safety of COVID-19 vaccines.

  • Reflect On:

    Why are people hesitant to take the vaccine? Why are scientists and journalists who explain why hesitancy may exist censored?

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A new study published in the journal Vaccines by three scientists and medical professionals from Europe has raised concerns about the safety of COVID vaccines, and it’s not the first to do so. The study found that there is a “lack of clear benefit” of the vaccines and this study should be a catalyst for “governments to rethink their vaccination policy.”

The study calculated the number needed to vaccinate (NNTV) in order to prevent one death, and to do so they used a large Israeli Field study. Using the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl), the researchers were able to assess the number of cases reporting severe side effects as well as the cases with fatal side effects as a result of a COVID vaccine.

They point out the following:

The NNTV is between 200-700 to prevent on case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95 % confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. This lack of clear benefit should cause governments to rethink their vaccination policy.

The researchers estimates suggest that we have to exchange 4 fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2-11 individuals per 100,000 vaccinations. This puts the risk vs. benefit of COVID vaccination on the same order of magnitude.

We need to accept that around 16 cases will develop severe adverse reactions from COVID-19 vaccines per 100,000 vaccinations delivered, and approximately four people will die from the consequences of being vaccinated per 100,000 vaccinations delivered. Adopting the point estimate of NNTV = 16,000 (95% CI, 9000–50,000) to prevent one COVID-19-related death, for every six (95% CI, 2–11) deaths prevented by vaccination, we may incur four deaths as a consequence of or associated with the vaccination. Simply put: As we prevent three deaths by vaccinating, we incur two deaths.

The study does point out that COVID-19 vaccines are effective and can, according to the publication, prevent infections, morbidity and mortality associated with COVID, but the costs must be weighted. For example, many people have been asking themselves, what are the chances I will get severely ill and die from a COVID infection?

Dr. Jay Bhattacharya, MD, PhD, from the Stanford University School of Medicine recently shared that the survival rate for people under 70 years of age is about 99.95 percent. He also said that COVID is less dangerous than the flu for children.  This comes based on approximately 50 studies that have been published, and information showing that more children in the U.S. have died from the flu than COVID. Here’s a meta analysis published by the WHO that gives this number. The number comes based on the idea that many more people than we have the capacity to test have most likely been infected.

How dangerous COVID is for healthy individuals has been a controversial discussion throughout this pandemic, with viewpoints differing.

Furthermore, as the study points out, one has to be mindful of a “positive” case determined by a PCR test. A PCR test cannot determine whether someone is infectious or not, and a recent study found that it’s highly likely that at least 50 percent of “positive” cases have been “false positives.”

This is the issue with testing asymptomatic healthy people, especially at a high cycle threshold. It’s the reason why many scientists and doctors have been urging government health authorities to determine cases and freedom from infections based on symptoms rather than a PCR test. You can read more in-depth about PCR testing and the issues with it here if you’re interested.

When it comes to the documented 4 deaths per 100,000 vaccinations and whether or not it’s a significant number, the researchers state,

This is difficult to say, and the answer is dependant on one’s view of how severe the pandemic is and whether the common assumption that there is hardly any innate immunological defense or cross-reactional immunity is true. Some argue that we can assume cross-reactivity of antibodies to conventional coronaviruses in 30–50% of the population [13,14,15,16]. This might explain why children and younger people are rarely afflicted by SARS-CoV2 [17,18,19].

Natural immunity is another interesting topic I’ve written in-depth about. There’s a possibility that more than a billion people have been infected, does this mean they have protection? What happens if previously infected individuals take the vaccine? What does this do to their natural immunity? The research suggesting natural immunity may last decades, or even a lifetime, is quite strong in my opinion.

There are also other health concerns that have been raised that go beyond deaths and adverse reactions as a result of the vaccine.

As the study points out,

A recent experimental study has shown that SARS-CoV2 spike protein is sufficient to produce endothelial damage. [23]. This provides a potential causal rationale for the most serious and most frequent side effects, namely, vascular problems such as thrombotic events. The vector-based COVID-19 vaccines can produce soluble spike proteins, which multiply the potential damage sites [24]. The spike protein also contains domains that may bind to cholinergic receptors, thereby compromising the cholinergic anti-inflammatory pathways, enhancing inflammatory processes [25]. A recent review listed several other potential side effects of COVID-19 mRNA vaccines that may also emerge later than in the observation periods covered here [26]…Given this fact and the higher number of serious side effects already reported, the current political trend to vaccinate children who are at very low risk of suffering from COVID-19 in the first place must be reconsidered.

Concerns regarding the distribution of the spike protein our cells manufacture after injection have been recently raised by Byram Bridle, a viral immunologist from the University of Guelph who recently released a detailed in depth report regarding safety concerns about the COVID vaccines.

The report was released to act as a guide for parents when it comes to deciding whether or not their child should be vaccinated against COVID-19. Bridle published the paper on behalf of one hundred other scientists and doctors who part of the Canadian COVID Care Alliance, but who are afraid to ‘come out’ publicly and share their concerns. Byram, as many others, have received a lot of criticism and have been subjected to fact checking via Facebook third party fact-checkers.

A recent article published in the British Medical Journal by journalist Laurie Clarke has highlighted the fact that Facebook has already removed at least 16 million pieces of content from its platform and added warnings to approximately 167 million others. YouTube has removed nearly 1 million videos related to, according to them, “dangerous or misleading covid-19 medical information.”

It’s also important to note that only a small fraction of side effects are even reported to adverse events databases. The authors cite multiple sources showing this, and that the median underreporting can be as high as 95 percent. This begs the question, how many deaths and adverse reactions from COVID vaccines have not been reported? Furthermore, if there are long term concerns, will deaths resulting from an adverse reaction, perhaps a year later, even be considered as connected to to the vaccine? Probably not.

This isn’t the only study to bring awareness to the lack of injuries most likely not reported. For example, an HHS pilot study conducted by the Federal Agency for Health Care Research found that 1 in every 39 vaccines in the United States caused some type of injury, which is a shocking comparison to the 1 in every million claim. It’s also unsettling that those who are injured by the COVID-19 vaccine won’t be eligible for compensation from the Vaccine Injury Compensation Program (VICP) while COVID is still an “emergency”, at least in the United States.

Below is the most recent data from the CDC’s Vaccine Adverse Events Reporting System (VAERS). Keep in mind that VAERS is not without its criticism. One common criticism we’ve seen from Facebook fact-checkers, for example, is there is no proof that the vaccine was actually the cause of these events.

A few other papers have raised concerns, for example. A study published in October of 2020 in the International Journal of Clinical Practice states:

COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

In a new research article published in Microbiology & Infectious Diseases, veteran immunologist J. Bart Classen expresses similar concerns and writes that “RNA-based COVID vaccines have the potential to cause more disease than the epidemic of COVID-19.”

For decades, Classen has published papers exploring how vaccination can give rise to chronic conditions such as Type 1 and Type 2 diabetes — not right away, but three or four years down the road. In this latest paper, Classen warns that the RNA-based vaccine technology could create “new potential mechanisms” of vaccine adverse events that may take years to come to light.

There are a plethora of reasons why COVID vaccine hesitancy has been quite high. I wrote an in-depth article about this in April if you’re interested in learning about the other reasons.

Conversations like this are incredibly important in today’s climate of mass censorship. Who is right or wrong is not important, what’s important is that discussion about the vaccine and all other topics remain open and transparent. The amount of experts in the field who have been censored for sharing their views on this topic has been unprecedented. For example, in March, Harvard epidemiologist and vaccine expert Dr. Martin Kulldorff was subjected to censorship by Twitter for sharing his opinion that not everybody needed to take the COVID vaccine.

It’s good to see this recent study point out that the benefits of the vaccine, for some people, may not outweigh the potential costs.

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