Maria Gutschi: Health Canada’s change to the definition of ‘Safe and Effective’ Smells of Big Pharma Intimidation

How can they keep saying “safe” and “effective”?

Because the meaning and standards used were changed

I knew from the very beginning that criticizing the “safe” and “effective” narrative using data and facts were doomed to fail. I have spent many years convincing doctors that their safe and effective drugs are not as advertised but outcome data from studies and trials can be massaged. So you end up in the battle of the experts. So I concentrated on manufacturing, and quality and we did get some traction using this approach.

However, to get at the root cause of this narrative, we need to really understand how the national regulatory authorities actually assessed these products. My colleague David Wiseman has been following the FDA process for 3 years and dissects how the FDA went off the rails. He talks about it here:

David Wiseman on Trial Site News start at 39:45 or thereabouts

I will attempt to do the same for Health Canada.

Safe and Effective is a Term Defined in Law and Regulation

Interim Order

Canada did not have existing legislation that could be applied to authorization of a drug product in the context of a pandemic. The FDA used their existing EUA developed for a pandemic, and the European Medicines Agency (EMA) used a “fast track” or accelerated pathway used many times before and just adaped to the pandemic. I think this is why the EMA’s review is the most complete.

Canada therefore, introduced a temporary emergency authorization as a new legal rule, the Interim Order (IO), for a specific one-year time period, promulgated September 20, 2020. The IO was also designed to support “intellectual property considerations” so that there would be no delay in access to COVID-19 treatments for Canadians.

“Seriously? I think there is another rabbit hole there. I worked for the patent regime in Canada as a scientific officer and this smells of intimidation by Pharma to me.”

Comparison of Interim Order to Notice of Compliance (NOC)

Here I compare in a draft document I am writing how a normal drug is assessed to receive what is called a Notice of Compliance (NOC) in order for the manufacturer to market and sell the product. This is also a ‘full approval.’ Canada does not have a separate authorization for vaccines or biologics vs regular drugs. These are all considered “drugs” under the Food and Drugs Act. The FDA grants a specific biologic authorization for biologics, vaccines and gene therapies called the Biologic License Application or BLA.

 

Do you see it?

In regulations for an NOC in C.08.002(2) you need to establish the safety of a new drug with detailed report (part 2g). And you need substantial evidence of clinical effectiveness (part 2h)

In the Interim Order the Minister MUST approve? Really? Sufficient evidence that the benefits outweigh potential risks. So no standard for establishing safety and efficacy THEN doing a benefit vs risk assessment like we do for a regular approval. Basically if a ham sandwich looked liked it did something, the Minister was required to approve.

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Enlisting in the Military: A Very, Very Bad Idea

Wounded Vet: Don’t Die for Arms Industry Profits in Ukraine, China

by Fred Reed

If you are a young man wondering what to do with your life, you may consider enlisting in the military. Don’t.

Yes, the military has its appeal, or seems to. You may need a job. The uniform looks good. There can be adventure. You might get laid by Asian lovelies in foreign countries. These things have their appeal. They did for me as a young Marine. But they aren’t worth being mutilated, blinded, or spending the rest of your years in a wheel chair. This can happen. It does happen. And Washington doesn’t give a damn.

Recruiters won’t tell you of this. They are liars. They lied to me. They will lie to you. At the very least, they will talk only about good things that might happen, about college money and job training you might get but probably won’t. They will make you feel welcome. You are joining a team of brothers, they will say. You are a patriot. You are defending your country.

Don’t believe it. The US military does not defend America. The last time it did this was in 1945, at the end of World War Two. Since then, American soldiers were sent for twenty years to Afghanistan. Is Afghanistan America? No. Was it, is it, important to America? No. Then Iraq, Syria, Iraq again,and Serbia, bombing helpless cities. Iraq isn’t America. In my day – I’m an old guy – it was Vietnam, Laos, Cambodia, where 63,000 Americans died, and killed huge numbers of peasants who did nothing wrong–for no reason.

Washington is now getting ready to start a war with China.

China is on the other side of the world.

Let me tell you what the military does to young men, what Washington does. Long ago I was driving a truck near the Marine base in Danang, Vietnam. A bullet came through the windshield. The glass spatter went into my eyes, filling them with blood and blinding me for, as it turned out, several months. I lay for maybe an hour beside the road until a chopper finally came to take me to the Naval Support Activity hospital. For a couple of weeks a Viet nurse gave me a large injection of penicillin every few hours because if the blood got infected, that would be it for my vision.

Across the corridor from me were two Marines whose tank had been hit by an RPG, rocket-propelled grenade. It ruptured the hydraulic lines and the hydraulic fluid had exploded into flames. The two crewmen across from me had gotten out somehow, though horribly burned. I was told they were covered with a plastic sheet that dripped with evaporation from their burns, but I don’t know.

“The other two had cooked alive, burning, burning, in agony, skin sloughing off, unable to breathe in the flames, desperately trying to find the hatch. The two across from me said they could hear them screaming. It is what the military did to them. It is what the military will do to you.”

A recruiter might tell you that I am an old guy, and things have changed. No. They have not. The military still uses tanks, rifles, land mines, bombs, flamethrowers, artillery. Aircraft carriers, important for the upcoming war with China, still carry large quantities of jet fuel and explosives. They are barbecues waiting to be lighted. You can have your bowels blown out, or burn alive, as easily now as then.

Did Vietnam have anything to do with America? No. It’s on the other side of the freaking world. Likewise Afghanistan, Ukraine, Syria, Iraq. So why does the military, why does our government do it?

Answer: So the arms industry can make money. And so Washington can try to control the world.

“Are you willing to die, to spend your life in a wheel chair, to wear a colostomy bag full of your own shit and never have a date because you were gut-shot so Lockheed-Martin’s stock shares will go up? Don’t do it. Don’t let the bastards use you.”

The wars never stop because the money is sweet, the profits enormous.

Washington just finished twenty years of killing in Afghanistan, meaning twenty years of juicy contracts. How did this defend America? Now we have Ukraine, so far costing taxpayers over a hundred billion dollars. Is Ukraine America? The United States is falling apart as anyone can see and Washington sends money to Ukraine. Hundreds of thousands of soldiers and civilians, Russians and Ukrainians, have died there, for nothing. But of course most of that money going to Ukraine is used to buy weapons from the arms companies. Follow the dollar.

For Washington, for the arms industry–they are almost the same thing–long wars in distant places are desirable because companies like Lockheed-Martin and Raytheon can keep selling the Pentagon missiles, tanks, helicopters and simple things like gasoline at jacked-up prices. War is about money. Washington cares about money. It does not care about you.

Don’t let them use you.

I’ll tell you another story. I spent about a year on the eye ward, 4B, at Bethesda Naval Hospital as it was then called, just outside of Washington. In hospital wards you see what the military really does to people. There was a guy blind because a defective rifle grenade detonated on the end of his rifle. Another fellow had taken an AK round through the jaw, shattering the bone. The fragments had to be removed, leaving the flesh where his jaw had been hanging down in a formless blob like a wet sock. He ate through a nasogastric tube going through his nose. We called him Jawless.

Military wards are full of such. The one I most remember was a young Marine from Tennessee, maybe nineteen. One side of his face was grotesque hamburger. He was stone blind. I was nearby when his high school sweetheart, maybe seventeen, came to visit him.

“Johnny…Johnny…Oh, Johnny.”

So much for the marriage, I figured. What young high school senior wants to tie herself for life to a blind horror that she will have to lead around?

“The war in Vietnam was lost, of course, but it wasn’t in vain. It made unimaginable profits for the arms industry. Why do you think American wars last so long? If America wins the war, the money stops flowing. If it loses the war, the money stops. Keep the war going, and the money flows.”

This is the military the recruiters don’t tell you about. It is the real military.

Want to know the lousy medical care the Pentagon gives the wounded? An incompetent military eye surgeon managed to destroy my remaining good eye years later. To see the kind of thing that happens, read this at the Unz Review. It will show you what you can expect.

How We Defend America

Think what, if you enlist, you will really be doing. Let’s say that you are ordered to fire artillery at some city or village. In your impact zone, a little girl of seven, hit by shell fragments, looks down in surprise as her intestines fall from her stomach, and begins crying, then screaming. This happens, frequently. What do you think hot jagged shrapnel does to a soft young belly. She holds out her arms to mommy for help, this being instinct with the very young, before collapsing from profuse bleeding. Large blood vessels are found in the abdomen. Her mother goes stark bugfuck crazy, desperate to save her daughter but watching her die. It is how we defend America, see.

This is what the military is, what it does. It is what you will be used to do, directly or indirectly.

Those in Washington who will send you to kill people you have never met, and to be mutilated, do not themselves go to war. Rich young men do not enlist. Students at Harvard and Yale do not enlist. The military preys on, takes advantage of, ordinary kids, usually high-school grads, often from the South.

If you are twenty years old, what I am about to say will be ancient history, but I ask you to think about it. The same thing is going on today.

The following men were all of military age during Vietnam, and they now rule the country or did: President George Bush II, Bill Clinton, John Bolton (of whom you have probably never heard, but a major warhawk), Biden, Trump. All avoided military service. All now want to send you to wars.

To express it clearly, they see you as suckers. Think about it.

I tell you, as one who has been there, who has seen it. Don’t let them use you.

Fred Reed started as a Navy brat born in 1945 in a coal town in West Virginia. His father was serving on the USS Franks, a destroyer in the thick of the Pacific war at places like Iwo Jima, Guam, and the Battle of Leyte Gulf.

Throughout his school years, Reed was “the kid other kids weren’t supposed to play with.” After graduating high school he rode freight trains across the USA and Mexico until joining the US Marines out of boredom. He returned from Vietnam mostly blinded and spent a year in hospital recovering enough sight to function.

Reed became a war correspondent in the early 70s and covered wars and military conflicts in the Middle East and Asia. He was one of the last US correspondents to leave Saigon and Phnom Penh.

Later he became the Law Enforcement correspondent for the Washington times. Fred Reed is married to the perfect woman and is based in Mexico where he has lived for many years.

Fred Reed Website: Fred On Everything

Fred Reed Biography and Books

Former RCMP Union Director: Windsor Police Constable Michael Brisco Deserved A Fair Trial

Guest Column by Retired RCMP Officer & Union Director Leland Keane

“Mike Brisco deserved a FAIR trial. The tyrants in police management and the Police Commission who refused him one are unworthy of public trust.”

An open letter from Leland Keane to the Ontario Civilian Police Commission and Windsor Police Service:

From: Leland Keane
Date: Thu, Apr 4, 2024 at 8:38 PM
Subject: Support for Windsor Police Constable Mike Brisco
To: Ontario Civilian Police Commission
Cc: Windsor Police Service, Justice Centre for Constitutional Freedoms

Dear Sir or Madam,

I read about the case of Constable Mike Brisco some time ago;

Cop fined two weeks pay for $50 convoy donation asks for judicial review (Western Standard – Lee Harding)

I retired in 2019 after 32 years with the RCMP in BC, the majority of my service being in uniform and street-level policing. In provinces outside Ontario and Quebec the RCMP does the same job as our municipal and provincial brothers-in-blue.

I served on the executive of the Mounted Police Professional Association of Canada (MPPAC) from 1996-2018 and retired as a director of that magnificent organization. I was blessed to have advocated for police and police veterans.

“The obvious injustice perpetrated against Cst. Brisco by less-than-ethical police management and pseudo-jurists at the police commission is an odious display of malicious prosecution of Brisco and by implication of any honest police officer.

The malicious prosecution of those who dared stand up to tyranny by all levels of government in this country since 2020 has and will have a very detrimental impact on our institutions and those who keep us safe at night for many years to come.”

The people involved in this prosecution and those who stood idly by at Windsor Police and the Police Commission remind me of those who stood by and watched and those who participated in Kristallnacht in 1938; cowards, tyrants and bullies.

Please remember that tyranny was internationally and publicly repudiated in 1946 at Nuremberg. Canada, to heal our society after the tyranny of 2020 which is still perpetrated by governments and agencies, will require a Nuremberg-style solution.

“Government-ordered violence perpetrated by those in uniform against the Freedom Convoy in Alberta and Ottawa continue to haunt all freedom-loving Canadians, especially those of us who kept our oaths not to obey unlawful commands.”

Those that escaped judgement at Nuremberg still faced judgement day which comes to us all.

Mike Brisco deserved a FAIR trial. The tyrants in police management and the Police Commission who refused him one are unworthy of public trust.

Mike Brisco deserved a fair shake. Instead he was punished with a 2 week rip and has suffered unthinkable personal and professional damage.

Shame on all who took part and those who stood by and watched.

God Bless and keep you Mike Brisco.

Yours truly,

Leland (Lee) Keane

RCMP (Retired)

Editor’s Note: This email received minor edits for spelling and flow.

Photo Credit: Western Standard and journalist Lee Harding.