“Safe and effective” – the hollow chant that should’ve sunk Big Pharma decades ago

The phrase “safe and effective” was not robbed of its credibility when the COVID-19 vaccines caused adverse events and deaths that embodied its antithesis. The duplicitous history of “safe and effective”, a phrase that has essentially become synonymous with another insidious slogan, “FDA approved”, goes back decades. On average, the FDA has recalled 1,279 drugs per year since 2012. Thalidomide, a sedative drug that was used to treat morning sickness in the 1950s, and Vioxx, a painkiller that was often prescribed to treat arthritis pain, are two of the most notorious drugs recalled by the FDA. Both were promoted to the public as safe and effective with tragic consequences. This article by Gavin de Becker, bestselling author of The Gift of Fear: Survival Signals That Protect Us from Violence whose work in the prediction and prevention of violence has earned him three presidential appointments, astutely assesses the absurdity of the FDA and CDC’s continued promotion of COVID-19 vaccines, as well as the utterly irrational trust still placed in Big Pharma when their track record provides endless reasons not to. This article first appeared on The Defender. – Nadya Swart

‘Cause Unknown’: Ed Dowd’s Pioneering Exploration of Sudden Deaths After the Rollout of COVID Vaccines

What Ed Dowd has done in his book, “‘Cause Unknown’: The Epidemic of Sudden Deaths in 2021 and 2022,” encourages us to bring our own curiosity and scepticism to the present unprecedented moment, in which new and little-tested Pharma products are being injected into the majority of people on Earth.

By Gavin de Becker*

Editor’s Note: This is the Afterword to Edward Dowd’s new book, “‘Cause Unknown’: The Epidemic of Sudden Deaths in 2021 and 2022.”

A quick thought experiment:

Imagine that thousands of healthy young Americans died suddenly, unexpectedly, mysteriously — and then kept dying at an alarming and escalating rate. (Once upon a time), that would trigger an urgent Centers for Disease Control and Prevention (CDC) inquiry to determine the cause of the deaths.

Imagine attentive and curious public health officials discover the decedents had all repeatedly ingested a new and little-understood drug. Next, the officials determine to a certainty that the drug these kids took has a clear mechanism of action for causing inflammation of the heart and other cardiac injuries in some people.

They learn that public health officials in other countries have seen the same thing and stopped recommending this same drug to young people. Next, some of the most senior and revered scientific advisors to the U.S. government publicly recommend the drug be stopped for young people.

Finally, thousands of doctors around the world sign petitions and write op-eds opposing the drug for young people. Experts from Harvard, Yale, MIT, Stanford and Oxford universities come forward to voice their concerns.

Alas, that thought experiment doesn’t require any imagination, because it’s exactly what’s occurred — except for the part about attentive and curious CDC officials rushing in to inquire. That part I had to make up.

In the pre-COVID-19 world, wouldn’t inquisitive reporters chase such a story, and wouldn’t the U.S. Food and Drug Administration (FDA) pause administration of the new mystery drug until a comprehensive inquiry was complete?

And above all, wouldn’t such a drug have quickly become a leading suspect worth considering for its possible role in the deaths?

Somehow, those have become rhetorical questions.

But not to Edward Dowd. His pioneering exploration of these sad sudden deaths was months ahead of the Wall Street Journal (WSJ) story about a lethal conundrum facing insurance companies.

Apparently, as mass vaccination progressed in 2021, excess death claims in working-age Americans tripled. Given the temporal relationship, might there be a connection between vaccines and these deaths?

Apparently not, because the WSJ story didn’t even mention mass vaccination among the causes worth considering:

  1. Delayed medical treatment from 2020
  2. People’s fear of seeking treatment
  3. Trouble lining up appointments
  4. Drug abuse and other societal troubles
  5. People not taking care of themselves
  6. Long COVID
  7. Not-yet-known long-term effects of COVID-19
  8. People dying later “from the toll COVID has taken on their bodies”

Numbers 1, 2 and 3 are all subsets of the same concept: impact of lockdowns and fear. Numbers 6, 7 and 8 are all subsets of the same concept: the impact of COVID-19 illness.

Aside from drug abuse and trouble getting doctors’ appointments, did anything else happen in 2021 that might possibly-maybe-perhaps-call-me-crazy be worth considering?

The insurers attributed most of the 2021 excess deaths to heart and circulatory issues, neurological disorders and stroke. It’s a coincidence, apparently, that nearly all of their deceased customers had just been injected with something known to cause heart and circulatory issues, neurological disorders and stroke.

Head-scratching by insurance industry CEOs and experts interviewed for the WSJ article was understandable, because, you know, how in the world could deaths possibly be linked to some brand new, never-before-used drug that was minimally tested, maximally rushed, mass-administered, and oh yeah, and by the way, is known to cause the very medical issues their customers were dying of?

(If you have any doubt as to whether the mRNA vaccines cause cardiac problems, see Appendix Four, Page 190, for a sampling of 100 published papers on vaccine-induced cardiac injuries to young people.)


Please forgive three more rhetorical questions:

  • Don’t Americans have plenty of excellent reasons to distrust Big Pharma companies?
  • Why is Pharma being afforded the kind of trust previously reserved for companies that don’t have a long history of criminal fraud?
  • What’s up with that?

Some relevant recent history: In 2021, a jury convicted Elizabeth Holmes of medical fraud. During the trial, she admitted that her company conducted medical tests using the same old machines that were supposedly being replaced by her remarkable new technology.

Though people were given fraudulent and incorrect medical results, the news media’s fawning over Holmes and Theranos kept the fraud alive for years, such that the company was eventually valued at $9 billion. Not a typo.

Theranos would not have been possible if the news media were sceptical or even curious when it comes to medicine and medical technology.

As you scan these few examples of news media promotion, consider that Vioxx and opioids and COVID-19 vaccines were all similarly floated into our society on a soft cushion of media praise, free of scrutiny or scepticism.

USA Today:

“Elizabeth Holmes is tall, smart and single. Well, maybe not truly single. ‘I guess you should say I’m married to Theranos,’ Holmes says with a laugh. Only she’s not kidding … while Holmes is a billionaire on paper, nothing seems to interest her less …

“‘We’re successful if person by person we help make a difference in their lives,’ says Holmes, who has a soft yet commanding voice that makes a listener lean in as if waiting for marching orders.”

New Yorker:

“Although she can quote Jane Austen by heart, she no longer devotes time to novels or friends, doesn’t date, doesn’t own a television, and hasn’t taken a vacation in ten years …

“‘I have done something, and we have done something, that has changed people’s lives … I would much rather live a life of purpose than one in which I might have other things but not that.’”


“The company she founded has the potential to change health care for millions of Americans.”


“Elizabeth Holmes, 30, is the youngest woman to become a self-made billionaire — and she’s done so four times over. ‘What we’re about is the belief that access to affordable and real-time health information is a basic human right, and it’s a civil right,’ she says.”

Since the news media could hardly change course after all that worship, it wasn’t any journalist who undid the Theranos scam. It was Stanford professor John Ioannidis who was willing to publicly point out that Theranos hadn’t published any peer-reviewed research about their products.

(To bring us to the present moment for a moment, that same John Ioannidis, esteemed physician, scientist and epidemiologist, was among the first and most vocal critics of lockdown policies. For that, he’s been the target of excoriation and cancellation by news media and the medical/Pharma cabal. Don’t you dare wake us from our COVID-19 fever dream, Professor!)

Back to Theranos: The company attempted to boost its credibility by getting then-Vice President Biden to visit their facility. In order to conceal the lab’s true operating conditions, Holmes and her team created a fake lab for the Vice President to tour.

The Theranos case should remind us that 25% of drugs approved by the FDA are later pulled from the market — so they can’t all be miracle drugs. Still, whatever a public health bureaucrat says today, the news media repeats, defends and then enshrines as fact.

Never has their lack of scepticism and curiosity about their biggest sponsors been on such colourful display as during the last two years, during which they’ve constantly promoted and parroted false Pharma claims related to new vaccines, false claims about the new Pfizer COVID-19 treatment, false claims about ivermectin and every other false claim by Pharma and government.

Real journalism being MIA has left us helplessly living in a world of compliance rather than science.

Here’s a fast journey through some intentionally forgotten history: After the FDA approved Vioxx, there were many litigations related to the inconvenient fact that the drug doubled the risk of heart attack. How many litigations?

Oh … 27,000 of them, but who’s counting? Risk of heart attack sounds familiar, given that hundreds of studies have now found mRNA vaccines increase the risk of cardiac death in young males. But again, who’s counting?

Merck was eventually forced to withdraw Vioxx, and was ordered to pay criminal fines of almost a billion dollars for overstating the drug’s safety with a now familiar refrain: “safe and effective.”

Like today, when CDC and FDA are receiving hundreds of thousands of reports of adverse reactions to COVID-19 vaccines (e.g. myocarditis, stroke, blood clots, death), Merck told jury after jury that heart attack deaths had nothing whatsoever to do with their wonder-drug.

They fought lawsuits like … well, like a Pharma company, accusing plaintiffs of falsifying data. Pot/kettle.

When a jury awarded one widow $253 million, Merck appealed, and that award was overturned.

A bunch of other lawsuits followed, with Merck winning some, losing some — until a class-action lawsuit concluded that Merck had violated the law by selling a drug that was unfit for sale, because of, you know, doubling the risk of heart attack, or some such thing. And then …

Merck agreed to a mass tort settlement of $4.85 billion to end thousands of individual lawsuits. And then …

Merck announced a settlement with the U.S. Attorney’s Office, resolving the $950 million fine that had been levied against the company.

Did that end it? Nope, litigation with seven states remains outstanding today. But the real punchline is …

Vioxx is returning to market. Yes. We can look forward to breathless news media reports about another (likely renamed) wonder drug that’s safe and effective.

The story of Vioxx is not a cautionary tale; rather, it’s a regular event. A group of concerned scientists wrote about it in 2017:

“To increase the likelihood of FDA approval for Vioxx, the pharmaceutical giant Merck used flawed methodologies biased toward predetermined results to exaggerate the drug’s positive effects.”

You mean exactly like every other Big Pharma company does with every other drug?

Merck’s manipulation also included a pattern of ghostwriting scientific articles. Internal documents reveal that in 16 of 20 papers reporting on clinical trials of Vioxx, a Merck employee was initially listed as the lead author of the first draft.”

You mean like every other Big Pharma company does with every other drug?

An FDA insider testifying on the agency’s failure to quickly recall Vioxx said it was the equivalent of allowing “two to four jumbo jetliners” to crash every week for five years.

The jumbo jetliner analogy is relevant again today, and action by the FDA seems nowhere in sight.

What Ed Dowd has done in this book encourages us to bring our own curiosity and scepticism to the present unprecedented moment, in which new and little-tested Pharma products are being injected into the majority of people on Earth, billions of doses thus far, another 4 million each day, evermore including children, even infants, authorised by an FDA that tried hard to keep Pfizer’s clinical trials data secret from the public.

To be more accurate, the FDA was perfectly willing and happy to release the information to the public, only they asked for 55 years to do so. To be even more accurate, the FDA (joined by its partner, Pfizer) later petitioned the court to allow them 75 years to disclose all the information.

Does the fact that the FDA fought so hard to keep the Pfizer safety results secret from the public make you curious?

Well, don’t expect any answers from the FDA, now run by a man named Robert Califf. Due to his Big Pharma conflicts, Califf would be ineligible to even serve on an FDA advisory committee, but he is nonetheless the Commissioner, on his third tour of duty at the FDA because, well, the revolving door spins fast, and so does he.

Califf presided over FDA approval of oxycodone use in children as young as 11, high-dose hydrocodone drugs and also the drug Addyl that was later recalled, among several others. For each of these approvals, the FDA overrode its own advisory committee of experts, and Califf gave his approval.

Califf founded a group to do clinical trials, and more than half of his $230 million funding came from … Big Pharma. Almost done. Califf was also paid as a consultant by the 15 biggest Pharma companies. And finally, sure, he was a cheerleader for Vioxx.

So of course he’s commissioner of the FDA.

And don’t expect much curiosity or scepticism from CDC Director Rochelle Walensky either. Here she is in March of 2022, displaying her willful gullibility about Pharma claims:

“I can tell you where I was when the CNN feed came that it was 95% effective, the vaccine. So many of us wanted to be hopeful, so many of us wanted to say, okay, this is our ticket out, right, now we’re done.

“So I think we had perhaps too little caution and too much optimism for some good things that came our way. I really do. I think all of us wanted this to be done.

“Nobody said waning, when you know, oh this vaccine’s going to work. Oh well, maybe it’ll wear [laughs], it’ll wear off.

“Nobody said what if … [the vaccine is] not as potent against the next variant.”

She couldn’t predict that vaccines might be less effective against new variants? You mean, like the flu vaccine has done every year for decades?

She couldn’t predict that the vaccine would wane, like the flu vaccine has done every year for decades, like even measles vaccines, and tetanus vaccines?

Dr Walensky was once chief of infectious diseases at a hospital where I’d never want to be a patient if she is chief of infectious diseases. But who am I kidding, she’s not going back to that hospital; she’s more likely to join Pfizer’s Board of Directors. Former FDA Commissioner Scott Gottlieb is already there waiting for her.

Dr Walensky’s catchphrase, “Too little caution and too much optimism,” could be a lyric in CDC’s most famous song, Safe and Effective.

To better understand how the agency always concludes that every vaccine is safe and effective, consider a vaccine so old that all its risk factors are already known: the smallpox vaccine.

From the CDC website, this morning:

“The smallpox vaccine is safe, and it is effective at preventing smallpox disease.”

Let’s see what safe means to the CDC:

Serious Side Effects of Smallpox Vaccine

  • Heart problems
  • Swelling of the brain or spinal cord
  • Severe skin diseases
  • Spreading the virus to other parts of the body or to another person [huh?]
  • Severe allergic reaction after vaccination
  • Accidental infection of the eye (which may cause swelling of the cornea causing scarring of the cornea, and blindness)

The risks for serious smallpox vaccine side effects are greater for:

  • People with any three of the following risk factors for heart disease: high blood pressure, high cholesterol, diabetes
  • People with heart or blood vessel problems, including angina, previous heart attack or other cardiac problems
  • People with skin problems, such as eczema
  • Women who are pregnant or breastfeeding

That’s going to be a lot of people risking brain swelling, heart problems and blindness, given that millions of Americans have had heart attacks “or other cardiac problems,” 17 million Americans are pregnant or breastfeeding, 31 million have eczema, 34 million have diabetes, 76 million have high cholesterol and 109 million have high blood pressure.

Describing the people at risk of serious side effects from the safe and effective smallpox vaccine, CDC includes people with a “family history of heart problems.”

Do you know hardly anyone who doesn’t fit that category?

So, while the CDC definitively states “The smallpox vaccine is safe,” they then exclude the majority of Americans it might be safe for.

Clearly, the term safe means different things to different experts. Here, for example, is the Mayo Clinic’s view of the exact same vaccine the CDC calls safe:

“It can sometimes cause serious side effects, such as infections in the heart or brain. That’s why the vaccine is not given to everyone. Unless there is a smallpox outbreak, the risks of the vaccine outweigh the benefits for most people.”

But Gavin, since there’s no outbreak of smallpox, why worry about what’s on the CDC website? Because … wait for it … the CDC is right now actively promoting that same smallpox vaccine to prevent monkeypox, and nearly a million Americans have already had the pleasure. (I guess it’s people with no family history of heart problems.)

And why have just one smallpox vaccine when you can have two?

safe and effective

You now know that when CDC says “safe and effective,” that’s because CDC never met a vaccine they didn’t like. It’s a belief system — not science.

Carefully reading Ed Dowd’s comprehensive analysis of new excess deaths and highest-ever disability among Americans, I was struck that he never once asks us to take his word for anything, and always puts the original source material right in front of us.

Even so, and even though he’s a brilliant analyst coming to this topic unconflicted, could we really rely upon Ed Dowd’s conclusions over the conclusions of the famous and powerful Drs Fauci, Califf, Bourla and Walensky?

That was my last rhetorical question.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

© [01/04/23] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

*Gavin de Becker is the best-selling author, “The Gift of Fear.”

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