Restoring trust and value in clinical trials and applying that to the upcoming tsunami of circulatory and organ diseases

Phase 3 clinical trials/studies are intended to be a representative sample that – with small sampling error – informs the benefits and harms that a treatment will have on a large population – with reasonable certainty. These can of course be tailored to any demographic or the entire population, The more granular the better and the smaller the sample error the more certain we can be about taking the treatment.

We have seen how the C19 mRNA and viral vector injections FAILED both In terms of getting approval outcomes over a fraudulently conducted clinical trial/study and by abbreviating the period of review,

“Warp Speed” was a headlong rush into the brick wall of reality, Neither money nor shortcuts provided a solution – only an atrocity,

We now know that the harms from the clinical trials/studies far outweighed any manipulated and misrepresented benefits.

The clinical trials are in Stage 4 which is due for completion this year.

This is not to say that the principles behind the trials are faulty – rather it reflects the abuses and shortcomings of trials conducted by mercenary pharma companies and regulators who failed to state the bleeding obvious – the C19 injections FAILED the trials.

It is interest to me that two of the top regulators that resigned ahead of the roll-out of the injections have not been asked about the trials and the roll-out of the booster injections in 2021.

From here on 1 September 2021:

Two senior FDA officials resign over Biden administration booster shot plan (nypost.com)

“Two senior officials have resigned from their positions within the US Food and Drug Administration over frustrations with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without their prior approval, according to a report.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause are set to leave the agency this fall, with sources telling Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.”

Gone but not forgotten. Are they keeping a retirement package only on condition of staying silent on their concerns? Were they troubled by revelations about the clinical trials and the discovery of a different process used I manufacturing doses compared to the clinical trials? 18 months in to the “scamdemic”, the con became too obvious to ignore – a booster after 4-8 months with no testing? The staggering rates of adverse events gave them pause. It was the deaths and injuries revealed in the post marketing authorization report?

Yet, no politician at the State or Federal level has interviewed these two most senior regulators about the motivation for their resignation. Curious.

Moving on.

Big pharma committed as many deadly sins of omission as the regulators. We are all by now familiar with the differences between Absolute and Relative risk.

What does not seem to be used as a base is that the clinical trials/studies had one end point – to reduce symptoms. Not to precent infection or death – just symptoms (remember all the bally Hoo about “cytokine storms”?

We know now that the injections should have been regulated as gene “therapies” and not “vaccines”. Sec filings clearly state that the “treatments” were gene therapies. There is a far more onerous path to follow to get a gene “therapy” approved, compared to a vaccine. It is not just the different compensation schemes VICP for vaccines and CICP for “countermeasures” where nuances are applied.

We know that the clinical trials/studies were conducted amongst healthier individuals aged between 18 and 55 – not the elderly and infirm, and certainly not amongst pregnant women or men seeking to start a family.

Similarly, although C19 was hitting the most vulnerable who were getting other treatments, no studies on the interaction of the injections were conducted – and yet these were the people who received the first injections. A fit person with no co-morbidities is likely to be far more tolerant of the injection of chemicals than an elderly or pregnant vulnerable person.

It is doubtful whether anyone would have taken an experimental injection if it had been made clear that the injection was experimental, and trials indicated a reduction of just one infection in a 100 (Absolute Risk Reductio).

Big pharma and the regulators were guilty of many crimes – perhaps three of the most egregious crimes – 1) not pointing out that the injections did not prevent infection, 2) that the rate of harms was higher than C19, and 3) that the injections were being made using a different process than that used in the trials.

We are all left wondering – how much at risk are the injected – ad how can they check and how many “vaccines” on the market are subject to the same failings of misinformation and risk of more harm than the condition they are intended to treat.

Autism is a hot topic. Rates were one case in 10,000 in the 1960’s and are now 1 in 300 – in other words rates are down from 100 in a million to 3,333 in a million. Regulators state that “vaccines” are not to blame – yet, do you notice that they have not come up with a cause for this effect? CDC = disease control? Looks like it is out of control to me!

Ok, so we have abuse of a system intended to reveal harm. Not much you can do about fraud from the level of big pharma all the way to the approval of a regulator in an emergency – well, this is changing,

But what can we do to make it crystal clear and enable (more) informed consent?

I have suggested I past articles  that we need to embrace several concepts.

1.      Quality Life Years Lost

2.      Life Years Lost

3.      Umber Needed to Vaccinate to prevent a tiered level of seriousness of adverse event

Note that these criteria can be stood on their head, so that we are not always proving a negative. How about using the terms “gained” instead of lost.

In this way, a budget for demographics can be worked out and questions like “does Novavax have no harms and some benefits for all blacks or just some?” – or “does Moderna cause fewer harms for the same benefits as Pfizer in older white women?”

These metrics can be combined with the rate of adverse events from the treatment for demographics – race, gender, age to better ascertain the benefits to harms ratios.

It would be desirable to compare the price of different treatments also to work out the incremental benefits for incremental costs.

Check this out for how cost effective EARLY TREATNENT is with Vitamin D is to save one life – 14 bucks (melatonin is just 11 bucks) compared to 1.5 million for Remdesivir and 182,000 for Paxlovid. I wonder what the kickbacks are like!!!

COVID-19 early treatment: real-time analysis of 3,881 studies (c19early.org)

That site has links to almost 6,700 treatments for early, mid and late stages – along with links to all the studies backing them up. Easy to spot the outliers and check out whether the research is out of line with others or not!

The “number needed to vaccinate” is a crucial one. If it takes 100,000 doses to prevent a single infection or serious or severe symptom or death – and the 100,000 doses cause 20,000 adverse events of which 2,500 are severe (life altering) events, 1,200 serious (life threatening) events and 200 deaths (close to clinical trial outcomes) – this should be on the package insert as part of informed consent!

A remaining issue for “number needed to vaccinate” is the time period. The numbers can be placed in time slots of one week, plus 1, 4, 6 and 12 months on a table that is not too busy and is easy to understand. Confidence intervals and P values o a separate table with an explainer of what those mean!

Here’s a suggestion for a change to how clinical trials are conducted and funded.

I suggest that local, city, state and federal governments independently supervise and fund ALL Phae 3 clinical trials – NOT companies, individuals, or groups. There is a kicker though, If the trial fails to provide a solution – beyond harms – then the companies, individuals or groups MUST PAY for the Phase 3 trial/study. A bond could be posted for half the cost of the study/trial. Otherwise the government entity pays for the trials – because there will be a benefit to the population.

A successful trial could be paid for with “royalties” paid to the independent body running the trials and back to the government entity.

Back to the concepts of quality life years (gained or lost) and life years lost.

“Life years lost” (LYL) is a raw metric that can be reconciled to life expectancy at the individual and aggregate, average, level. It can be applied to someone with a disease/infection and is, of course, an estimate. What were the “life years lost” due to C19? Again where fraud exists, this is a tricky problem. If 95% or even 100% of C19 “cases” were fraudulently detected by an unfit for purpose RT-PCR test that determined 1,2 million people died with C19 present, ALL analysis is confounded (or dumbfounded in my parlance).

This is the price of fraud – bad diagnoses and bad corrections.

Life years lost does not consider the quality of that life. A person kept alive whilst hooked up to all sorts of machines with no prospect of recovery has no life. Similarly, a person who wats to die and who does not want treatment is a candidate for “assistance”. This is a question of ethics and morals. If a person would commit suicide but is unable, should the state appoint an executioner> What if the State does not or cannot afford the treatments that prolong life?

Another concept is “Quality Life Years  Lost” (or Gained) again is as much subjective as objective, but, I suggest, is much more important in terms of a course of action during either an emergency or even in “normal” times.

We can use the metric to determine harms from adverse evets AND can use it to better qualify and quantify benefits, not just to the individual, but also to the insurance company that insures that individual AND at the Federal, Stare, City or local level., for the uninsured OR the under-insured.

See what you think!

Onwards!

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