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How Big Pharma Chooses Which Drugs To Develop

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Pharmaceutical manufacturers are businesses, not healthcare companies. Their business is making profitable drugs that will be widely prescribed by doctors and used by as many consumers as possible. As business people, their primary loyalty is to their shareholders. All decisions on which compounds to develop into drugs and which to bring to market are driven by profit, the competitive landscape, and speed to market.

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“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” Dr. Richard Horton, the current editor-in-chief of the Lancet

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There are several key therapeutic areas that are dependable money makers and have the potential to produce possible blockbusters: drugs to treat cardiovascular disease, diabetes, cancer, and central nervous system disorders. Many of the diseases that these drugs treat are lifestyle related illnesses. If many of these symptom sufferers led a healthy lifestyle, they could reverse and/or prevent many of these diseases. But Pharma is not in the disease prevention business. They are in the disease treatment business. Doctors are not taught to promote wellness and prevent disease, they are taught to treat disease. So, prescriptions are dispensed as first line therapy for most symptoms.

When consumers feel they can control their symptoms and ultimately, their health, by just popping a pill, they mistakenly believe that they are also overcoming their disease. But by not changing their lifestyle, they are just masking the symptoms. For example, in the case of cardiovascular disease (CVD) and diabetes, by not choosing a healthier diet and by retaining extra weight (especially abdominal body fat), patients remain prone to other diseases and will subsequently require more medications. Patients who take daily medication are also unknowingly taxing their organs incrementally. It is in Pharma’s best interest that you not make lifestyle changes, but instead choose to take their drugs to treat your symptoms. Your disease may stabilize, but it will not reverse. If you will not change your disease-causing lifestyle, you will become dependent on the drug to manage your symptoms. Any side effects of the drug will lead to more drugs to treat those symptoms. It’s a vicious cycle that keeps Big Pharma profitable.

“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.”  – (source)(source) Arnold Seymour Relman (1923-2014), Harvard Professor of Medicine and Former Editor-in-Chief of the New England Medical Journal

So how do pharmaceutical companies choose which drugs to develop? They look at what have been blockbusters (big sellers) in the past and make more of those. Hypertension is great example of a blockbuster gateway drug. The Framingham Heart Study, under the direction of the National Heart, Lung, and Blood Institute (NHLBI), began studying cardiovascular disease (CVD) in 1948. After each study, they report their findings. In 1967, the Framingham Heart Study reported: “Physical activity found to reduce the risk of heart disease, and obesity to increase the risk of heart disease.”1 Yet physicians were not trained to recommend increased physical activity to their hypertensive patients. They were trained to prescribe drugs to treat hypertension (HT). Guidelines were set as to what constituted HT and at what number doctors should prescribe medication to reduce blood pressure.2

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In 2015, The New York Times reported that SPRINT, the study on 9,300 men and women who were at risk of heart disease, would be terminated early because the results were so compelling that the researchers wanted to publish as soon as possible. As a result of the published data, doctors and prescribing nurses were trained to prescribe HT medicines to people with lower diastolic and systolic numbers than they had prior to the published study. More patients on more meds. Nowhere are patients taught that hypertension can be lowered immediately with a 20 minute walk.3

Not only were the “favorable” data pushed down through the medical community, they were “pulled through” the patient community via major news publications such as The New York Times. Even more compelling, major media via magazine advertisements and promotional news spots on television called video news releases (VNRs) were used to reinforce the consumer messaging. All medical communications and consumer information is produced by Pharma’s ad agency. The SPRINT trial (Systolic Blood Pressure Intervention Trial) was designed with the outcome in mind. As soon as they reached their desired conclusion, the study was stopped to deliver the “good news” to the public and to change the protocol for what determines HT. Now, doctors were prescribing HT meds earlier to patients who might not be at risk in the interest of protecting their vasculature from possible future heart disease.

As an aside, the SPRINT study was named by the advertising agency used to brand the clinical trial. Controlled brand building generates excitement and allows the marketing message dissemination to begin with a catchy name that connotes a positive forward-thinking movement. These names are not pulled out of the air. They are carefully crafted by expert marketers who know how to prep and sell the target market on the concept they endeavor to get adopted by program, protocol, and product advocates. The advocates are Thought Leaders in CVD who are already talking about the trial before it has even been completed, thus influencing lower-tier prescribers all the way down the chain to your own General Practitioner.

The protocol was written in advance of the study by the medical education agency, a subsidiary of the advertising agency, and the spin began long before the trial did. As a result, a soon-to-be launched new HT medication was not only embraced, but reached blockbuster status right out of the gate. The SPRINT trial was funded by the NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Those organizations received their grant money from the pharmaceutical industry, most notably from the company whose drug was planned to launch upon the release of the new data.

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment 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” Dr. Marcia Angell, a physician and long time Editor in Chief of the New England Medical Journal (NEMJ)

In summary, I’ll quote J. Michael Pearson, CEO of Valeant Pharmaceuticals, who flat out admitted on April 13, 2016 that his first responsibility is to the shareholders, not to the furthering of healthcare outcomes and the consumers of their drug products. Instead of investing in new breakthroughs, Valeant relies on lucrative drug acquisitions and price hikes. “If products are sort of mispriced and there’s an opportunity, we will act appropriately in terms of doing what I assume our shareholders would like us to do.”4

More and more, it is only the wealthy who can afford quality healthcare, not the average consumer with modest healthcare insurance plans. In 2016, 56 of Valeant’s drugs increased in price by 66 percent. Their latest drug acquisition prompted a 550 percent price increase. “My primary responsibility is to Valeant shareholders. We can do anything we want to do. We will continue to make acquisitions, we will continue to move forward.” Stock prices for Valeant rose 1,000 percent since Pearson became CEO.5 With that message coming from the top, it’s easy to see how patients are the ones who will suffer from Pharma’s greed. Pharmaceuticals continue to make choices based on how much money they will make, not on how many patients they can help.

SOURCES

1 https://www.framinghamheartstudy.org/about-fhs/research-milestones.php

2 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2904478/

3 http://www.nytimes.com/2015/09/12/health/blood-pressure-study.html?_r=0

4 http://www.cbc.ca/news/business/valeant-senate-deposition-1.3533698

5 http://usuncut.com/class-war/valeant-ceo-shareholder-profit/

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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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