DOCTORS, MEDICINES AND “REGULATION”

My Sons of Issachar newsletter this week is a little shorter than usual because I have been in Sydney seeing a range of doctors who are diligently trying to discover why, about 6 weeks ago, I almost died from blood clots in my lungs.

I have greatly appreciated my excellent medical care. Still, my concern originally was if the doctors did enough tests, then statistically, they would find something that fell outside the normal range. This is because every measurement has a normal range based on 95% confidence limits. So there is a one in twenty chance of an “abnormality” that may not be clinically significant. My doctors have found a range of “abnormalities”, and now they are on the hunt for what may be the cause or causes. I am grateful for their concerns, but I also am wondering how far to proceed with tests. This is because abnormal test results inevitably result in the need for some pharmaceutical intervention. Increasingly I have become aware that the checks and balances that we all assume lie behind recommendations for prescribed medications are an elaborate ruse. More about this later.

It is interesting that as medicine has become increasingly specialized, it is difficult to find a doctor who is prepared to examine the whole patient and not just his or her area of speciality eg heart, lungs, blood, nervous system etc. I have become more aware of this recently because an ability to consider the whole patient and potential causes of disease are of great importance when considering problems that have arisen from COVID- 19 “vaccinations”. A wide range of abnormalities have been reported to be associated with the COVID-19 “vaccines” (see recent reports from Steve Kirsch below)

VAERS data is crystal clear: The COVID vaccines are killing an estimated 1 person per 1,000 doses (676,000 dead Americans)

and

BREAKING: Early onset dementia is being caused by the COVID vaccine (~25X increase)

However, it seems that most doctors are unaware of the relationship between COVID “vaccination” and significant health issues. Therefore, it seems more important than ever to find doctors who have an unblinkered view of health and are prepared to look at the whole person and the impact of various medications.

Few doctors will consider that some of the many problems affecting people’s health in the last year or so, could be from “vaccine” side effects. I personally know of at least one dozen people who have had problems such as blood clots, heart attacks, immunity disorders, reproduction problems, the appearance of sudden cancer, or neurological problems, since taking the COVID-19 “vaccines” and boosters (some of my family members have had up to seven injections of the experimental and ineffective injections because of advocacy by their doctors). Fortunately, I declined the vaccine, despite my local doctor telling me it was “completely safe”. I was helped by remembering the simple admonition from President Reagan: “The nine most dangerous words in the English language are, I’m from the government and I’m here to help”. We always should beware of government “help” and what lies behind it.

Of course, as the vaccine advocates point out: “correlation doesn’t indicate causation”. Nonetheless, the “vaccines” have been widely used and even mandated, despite their experimental status. Most people are unaware of the limited trials that were done prior to “vaccine” release and the fact that completely new mRNA technology was rushed into use with no long-term evaluation.  It also is hard to argue with the extensive findings in the US Vaccine Adverse Events Reporting System (VAERS) database – see this link.

So, you wonder then how it could be that dangerous products are released and mandated for the general public? The answer to this question is that the regulatory bodies in most countries have come under the influence of the very drug companies that they are seeking to regulate. Conflicts of interest abound in the regulatory process, and we cannot trust that regulators ensure that the public is protected.

Most jurisdictions around the world have placed significant reliance on the US Food and Drug Administration (FDA), which has long been seen as the “gold standard” for ensuring the safety of medications and vaccines. However, “Big Pharma” has hijacked the drug approval process, as noted in an article in Forbes magazine in 2018, The Biopharmaceutical Industry Provides 75% Of The FDA’s Drug Review Budget. Is This A Problem?

The article asks the following question: “How did we ever get to the point where private industry is providing so much support for a federal agency? Actually, this all began about 25 years ago, when the U.S. was facing a “drug lag”. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate here than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. Patients, advocacy groups, pharmaceutical companies, and physicians were all concerned that important new medicines were being denied to Americans.

To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992–a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues, known as “user fees”, were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval.”

The positive result of the funding change was the approval of some important medications that have undoubtedly been of benefit to some patients. However, an unintended consequence was the approval of numerous drugs that have serious side effects. Many of these side effects are not demonstrated until years after the approval, by which time, many patients have suffered negative side effects, including death.

An article by Caroline Chen in 2018 pointed out some of the details of the negative impacts of the more hasty regulatory process associated with some specific drugs. She also noted the potential conflicts of interest for doctors who had received financial support from the pharmaceutical companies – see this link to her article, FDA Repays Industry by Rushing Risky Drugs to Market. Chen provides examples of various drugs that were licensed but subsequently found to have very serious side effects and caused many deaths. You would think that these results would have prompted officials to re-examine the funding policy. However, the sums of money involved are so vast, and the political lobbying so strong, that somehow the issues are never raised in the media and the Big Pharma ship sails on towards inevitable future icebergs knowing that there is protection on all sides from any negative consequences.

Most patients are unaware of the unholy alliance between drug regulators, physicians and pharmaceutical companies. Influential physicians are provided with travel grants and attend conferences to present their data on the benefits of various treatments. In the background of most conferences, during the meal breaks, lurks the influence of Big Pharma. While conflicts of interest are meant to be declared, the billions of dollars at stake are extraordinarily influential. Big Pharma has developed a sophisticated lobbying operation for doctors and this influences doctors prescribing habits. An article in the 2017 British Medical Journal (BMJ) Open concluded:

“Physician–pharmaceutical industry and its sales representative’s interactions and acceptance of gifts from the company’s PSRs (pharmaceutical sales representatives) have been found to affect physicians’ prescribing behaviour and are likely to contribute to irrational prescribing of the company’s drug”.

It must be concerning to my readers to discover that pharmaceutical companies' promotion of drugs and the use of gifts for doctors can contribute to “irrational prescribing of the company’s drug”. Most of us go to a consultation with our doctor believing that the doctor has our best interests in relation to any medications prescribed. It is disturbing to find that, even if subconsciously, doctors may prescribe a drug because of a pharmaceutical company’s promotional materials and gifts. This interaction between doctors and Big Pharma often commences when future doctors are students are at medical school, and pharmaceutical companies sponsor student events and the provision of medical equipment.

My readers will be shocked to read a section from Dr Bessel van der Kolk’s seminal book, The Body Keeps the Score – published in 2014. Dr van der Kolk writes about the dramatic increase in the prescription of psychiatric drugs in recent years.

“The new generation of antipsychotics, such as Abilify, Risperdal, Zyprexa, and Seroquel, are the top-selling drugs in the United States. In 2012 the public spent $1,526,228,000 on Abilify, more than on any other medication. Number three was Cymbalta, an antidepressant that sold well over a billion dollars’ worth of pills, even though it has never been shown to be superior to older antidepressants like Prozac, for which much cheaper generics are available. Medicaid, the government health program for the poor, spends more on antipsychotics than on any other class of drugs. In 2008, the most recent year for which complete data are available, it funded $3.6 billion for antipsychotic medications, up from $1.65 billion in 1999. The number of people under the age of twenty receiving Medicaid-funded prescriptions for antipsychotic drugs tripled between 1999 and 2008. On November 4, 2013, Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it had improperly promoted the antipsychotic drug Risperdal to older adults, children, and people with developmental disabilities. But nobody is holding the doctors who prescribed them accountable.”

Note that Johnson & Johnson “agreed to pay more than $2.2 billion in criminal and civil fines” because it had “improperly promoted the antipsychotic drug, Risperdal”. There are many other cases of major drug companies being forced to pay out billions of dollars for the damaging effects of their products. We cannot assume that we can trust pharmaceutical companies and even our own doctors. Undoubtedly, improper prescribing also applies to many other drugs, but most of these cases never come to light. One hates to even contemplate what the number of prescriptions of antipsychotics and antidepressants is today, given the epidemic of “mental health disorders” in most Western societies.

Unfortunately for patients, Big Pharma has undertaken a cunning pincer movement to influence doctors and government drug regulators. Doctors are sweet-talked into prescribing new “miracle drugs”, lobbyists ensure government is on their side and the “independent” regulators are provided with funds to ensure various products make it through the regulatory process.

The medical profession itself has recently recognized the challenges involved in the area of drug regulation. An article published last year in the British Medical Journal (BMJ) asks the question: From FDA to MHRA: are drug regulators for hire?

Most Western jurisdictions have moved from a taxpayer-funded model for regulation of medicines and drugs to one funded by industry money. This has clearly benefited Big Pharma, since following the increase in funds provided to the FDA by pharmaceutical companies, similar processes have been implemented in Europe by the European Medicines Agency , the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) - and Australia’s Therapeutic Goods Agency (TGA).

Now, the BMJ has reported the extraordinary level of funding of regulatory assessment by pharmaceutical companies (which are increasingly concentrated into a few companies via mergers and acquisitions, hence the term “Big Pharma”). In addition, conflicts of interest of those on the various boards approving the medications may not be available to the public (see Table 1).

Table 1. Part of table from British Medical Journal - How the Regulators Compare

Australia is at the top of the list of industry funding for drug evaluations. The Australian regulatory body, the TGA, receives more than 96% of its funding from industry. Remarkably, 50% of the TGA board members reported a conflict of interest in relation to approval of COVID-19 vaccines. How could there possibly be an independent evaluation of the experimental “vaccines”, given these conflicts of interest and the political pressure for approval?

We, the public, believe that there is an independent process to evaluate medications and vaccines but unfortunately, in almost every case, conflicts of interest abound. The authors of the BMJ article note that there is often movement from lowly paid government regulatory positions to more lucrative positions with pharmaceutical companies. Maryanne Demasi reported in the BMJ article that:

“One study found more than a quarter of the FDA employees who approved cancer and haematology drugs between 2001 and 2010 left the agency and now work or consult for pharmaceutical companies.”

Like a slowly developing cancer, the regulatory framework has been insidiously captured by the pharmaceutical industry. What commenced as a “hands off” evaluation process 40 years ago is now thoroughly compromised and will get worse. The billions of dollars of profit made by Big Pharma with the rushed COVID-19 “vaccines” have set a precedent for other products to be hurried onto the market. Our health is more at risk from doctors and Big Pharma than ever before and we now have a new code phrase to warn us – “safe and effective” – which like so much government propaganda, means exactly the opposite.

The drug regulatory process reminds me of my tour some years ago with our family of the Universal Movie Studios in California. In many cases, elaborate facades provided the illusion of a functioning town, but the facades were just a shell. Gradually, the drug regulatory process has developed a similar façade of patient protection, but it has been subtly infiltrated by Big Pharma. It is a classical case of poacher turned gamekeeper or using a different analogy, kobuki theatre.

Every time we visit a doctor or have medication prescribed, is a case of caveat emptor – buyer beware. Most physicians are well-intentioned but because of busy lives may be ill-informed or even worse, wrongly informed by clever marketing by Big Pharma or government. I talked to many doctors after the COVID-19 experimental “vaccines” became available and I was staggered at the general lack of knowledge about the vaccines and their potential deleterious side effects. Most doctors were influenced by government public health propaganda and were fearful of having their own medical licenses revoked if they expressed any concerns. The Hippocratic Oath - has been forgotten, as the medical profession increasingly becomes another arm of Big Government.

We cannot outsource responsibility for our own health and so be extremely careful about recommendations for medications that are made by your doctor. Each of us needs to do our own research and there is substantial information available on the internet. Unfortunately, Big Tech has implemented various algorithms that give significant weight to government public health narratives and so-called “fact checkers”, almost invariably in the pocket of vested interests. You need to be careful with your search terms and seek alternative sources of information.

I have found a helpful technique to assess the willingness of doctors to consider narratives and evidence other than government and Big Pharma. Ask your doctor two questions:

1.     “Have you considered the prescription of ivermectin to assist in the treatment of patients with COVID?” (this may produce agitation or anger in your doctor, so take care how close you are to the doctor).

2.     If the doctor says “no”, follow up with a more complex question:

“Are you aware of the meta-analysis undertaken by Dr Tess Lawrie and colleagues, which found that ‘Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin.’”? This is a direct quote from the scientific paper published in June 2021 in the American Journal of Therapeutics titled Ivermectin for Prevention and Treatment of COVID-19 Infection: A Systematic Review, Meta-analysis, and Trial Sequential Analysis to Inform Clinical Guidelines – click on this link to download a copy of the paper.

If the doctor throws you out of his rooms and calls you a conspiracy theorist, find another doctor!

IMPORTANT NOTE: you may have to visit many doctors to find one who will answer yes to the two questions.

This post may be an unreasonably negative view of the medico-pharmacological-government complex but it is best to be informed and have a high index of suspicion about those who want to intervene in your health. I have just finished a round of consultations today with various medical specialists and I was impressed with their care and expertise. Nonetheless, I reminded myself that these clever doctors have been captured by government and Big Pharma. Once again I turned to my mainstay, President Reagan: “trust but verify”.

Amazingly enough, I am about to consult a naturopath and may even seek homeopathic treatments, areas that previously I thought were possibly witchcraft. I am confident that whatever these alternative practitioners prescribe, that the treatments are unlikely to kill me!