Biden’s Address – Beware the health danger of HARPA – modeled after DARPA

Biden in his address to the Nation, talked about Health Care Research…DARPA… and why we should be concerned.

Informed consent for experiments? Not always what you have been lead to believe. They hawk this proposed agency as:

Federal investment is the fastest, most effective way to de-risk the marketplace. HARPA will disrupt the health technology sector to drive meaningful innovation that will save millions of lives and billions of dollars.

HARPA is modeled after the Defense Advanced Research Projects Agency (DARPA),

…. As part of a proposed $9 billion increase to the National Institutes of Health, the Biden administration has earmarked $6.5 billion to create the Advanced Research Projects Agency-Health.

Under the DARPA model, research projects would not be vetted by peer reviewers, but instead, funding decisions would be made by program managers. And instead of multiyear grants, the agency would disburse awards as milestone-driven payments; program managers could also cancel projects that they decide aren’t panning out.

Before we get to the gist of the dangers of this agency creation and its program managers and for those who have concern about the COVID vaccines let me give a refresher on “Informed Consent” and the Cures Act.

Jan 31, 2020 — The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. (Link) 21st Century Cures Act

The Cures Act was passed in the tail end of 2016 under Obama. Today I focus on Section 3023, 3024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this? A previous post:

The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

I am not sure I for one want the Biden administration in charge of:

Human research subject protections

The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order “to reduce regulatory duplication and unnecessary delays” and “modernize such provisions in the context of multisite and cooperative research projects.” – Wikipedia,

Be sure and take the time to watch the video at the end of the post for the finer details.

The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.

The law sets two requirements for waiving or altering informed consent:

  1. The research must pose no more than minimal risk to participants; and
  2. Other measures to protect study volunteers must be in place.

The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.

From Science Blogs:

Title:The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. (Well worth the full  read.)

Worse, the bill undermines informed consent, as discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject.

Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”

As Merrill Goozner put it and agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk

Worth a good look. Our lives may depend on it. An excellent review of the bill and the ramifications.

Now that we know where we are, let’s see where we have been:

Let’s take a look how the so called research projects went under Obama since we have the same cast of characters roaming around the White House. This research was conducted by Lisa Jackson, EPA administrator.

A federal judge decided to shut down the lawsuit rather than the government’s human experimentation program.

To Judge Trenga, however, the important thing apparently was to nitpick to death the effort to stop the experiments with a narrow reading of the federal rules of civil procedure.

Judge Trenga determined that the EPA’s decision to endanger the lives of its study subjects, including inducing them to sign a fraudulent consent form, did not constitute a “final agency action” under the Administrative Procedures Act. Judge Trenga also determined, as the American Tradition Institute was not being harmed by the experiments, it didn’t have standing to pursue the case. Now the story:

The suit accuses the EPA of paying as many as 41 participants $12 an hour to breathe in concentrated diesel exhaust, for as long a two hours at a time. The exhaust was directly piped in from a truck parked outside the Chapel Hill facility. According to the lawsuit, the fine particulate matter, called “PM2.5,” was piped in at levels 21 times greater than what the EPA calls its “permissible limit.”

Milloy added some historic perspective to the mix. “In the context of rules established after scientific horrors of World War II and the Tuskegee syphilis experiments, the notion that EPA would pipe high levels of PM2.5 and diesel exhaust into the lungs of unhealthy people to see what would happen is simply appalling,” he said in a press release announcing the lawsuit.

“Unhealthy” is an accurate assessment. The 41 subjects who took part in the experiment included people who were elderly or suffering from asthma, hypertension or metabolic syndrome. One of them, an obese 58-year-old woman with a history of health problems and family history of heart disease, experienced an irregular heartbeat (atrial fibrillation) and had to be hospitalized as a result. Another subject developed an elevated heart rate.

Then again, the study subjects really weren’t “asked” to risk their lives, since the EPA researchers failed — and, in fact, refused — to warn them that PM2.5 could kill them. At the very least, exposing study subjects to a dangerous and deadly toxin without their consent is also known as “assault and battery.”

Given that the EPA long ago determined that any exposure to PM2.5 could cause death (as well as a host of other serious health consequences) within hours or days of inhalation, the experiments are fundamentally illegal. Federal regulations and the Nuremberg Code strictly prohibit scientists from treating human subjects like expendable guinea pigs. In the experiment in question, the study subjects were asked to risk their very lives for $12 per hour.

The American Tradition Institute sued the EPA in October to stop an ongoing experiment in which the agency was exposing elderly study subjects (up to 75 years of age) to concentrated levels of a deadly (according to EPA) air pollutant known as PM2.5 (soot or dust much smaller than the width of a human hair).

The lawsuit claimed the experiments were illegal in that they blatantly violated virtually every major standard developed since World War II for the protection of human study subjects used in scientific experiments.
The EPA engaged in disturbing experimentation that deliberately exposed human beings to airborne particulate matter the agency itself considers lethal. The experiments were conducted at EPA’s Human Studies Facility at the University of North Carolina in Chapel Hill. “That EPA administrator Lisa Jackson permitted this heinous experimentation to occur under her watch shocks the conscience,” said Milloy.

Full story at  Washington Times

Then there was this:

Obama orders Behavioral experiments on U.S. Citizens

President Obama announced a new executive order on Tuesday which authorizes federal agencies to conduct behavioral experiments on U.S. citizens in order to advance government initiatives.

“A growing body of evidence demonstrates that behavioral science insights — research findings from fields such as behavioral economics and psychology about how people make decisions and act on them — can be used to design government policies to better serve the American people,” reads the executive order, released on Tuesday.

The initiative draws on research from University of Chicago economist Richard Thaler and Harvard law school professor Cass Sunstein, who was also dubbed Obama’s regulatory czar. The two behavioral scientists argued in their 2008 book “Nudge” that government policies can be designed in a way that “nudges” citizens towards certain behaviors and choices.

The desired choices almost always advance the goals of the federal government, though they are often couched as ways to cut overall program spending.
Read more: Daily Caller

New Law Could Eliminate Informed Consent for Human Experimentation with Vaccines and Drugs – Video done on March 26, 2017.

Time well spent with the details…

The best of the swamp today folks.

CDC says masks have no statistical impact on spread of Covid – will continue pushing masks

 

All smoke and mirrors. Keep wearing those rags folks. Here is the report with government word salad. So Dr. Fauci what is the bottom line?

The CDC recommends wearing masks after their study showed that related to COVID, the results of wearing masks were statistically the same as the results when not wearing masks.

During March 1–December 31, 2020, state-issued mask mandates applied in 2,313 (73.6%) of the 3,142 U.S. counties. Mask mandates were associated with a 0.5 percentage point decrease (p = 0.02) in daily COVID-19 case growth rates 1–20 days after implementation and decreases of 1.1, 1.5, 1.7, and 1.8 percentage points 21–40, 41–60, 61–80, and 81–100 days, respectively, after implementation (p<0.01 for all) (Table 1) (Figure). Mask mandates were associated with a 0.7 percentage point decrease (p = 0.03) in daily COVID-19 death growth rates 1–20 days after implementation and decreases of 1.0, 1.4, 1.6, and 1.9 percentage points 21–40, 41–60, 61–80, and 81–100 days, respectively, after implementation (p<0.01 for all). Daily case and death growth rates before implementation of mask mandates were not statistically different from the reference period.

The results of a CDC study at first appear to show that wearing masks help reduce the spread of COVID:

The results from before wearing masks were not statistically different than the period wearing masks – thus the CDC will continue recommending Americans wear masks???

 

Flashback to January 21, 2021 with Fauci, full of himself, telling us that  science rules.

 

H/T: Gateway Pundit

 

That is the best of the swamp today

Biden’s HHS Trans Doctor pick supports sex change for kids and puberty blockers

 

Remember when the Twilight zone was just a show on TV? Rand Paul nails down this candidate for Biden’s latest pick for weirdos to fill out his cabinet. This one is a doozy. Later the  background on this guy/gal who thinks it’s apparently great for kids to mutilate their bodies without parents knowledge.

Rand Paul puts Rachel’s feet to the fire with his well laid out question.

Biden nominee refuses to answer the question about whether the government should override a parent’s consent to allow a minor to receive puberty blockers or surgical amputation of breasts or genitalia.

“You’re willing to let a minor take things to prevent their puberty, and you think they get back?… You have permanently changed them… There’s no long term studies. We don’t know what happens to them.”

Charlie Kirk:

Joe Biden is pushing Rachel Levine through the Senate to be second-in-command at the Department of Health & Human Services. Rachel is a biological male who supports sex change surgeries & life altering hormone treatments for children. Is this what ‘healing the nation’ looks like?

 

 

That was not the only question of her that should be a headliner:

Levine questioned on missing Pa. nursing home data in …

Penn Live

HARRISBURG — During a federal confirmation hearing Thursday, former Health Secretary Rachel Levine was questioned about the ongoing data discrepancies in Pennsylvania’s public reports on nursing home coronavirus deaths and cases.

U.S. Sen. Susan Collins (R., Maine) said Levine had assured her that Pennsylvania had accurately reported deaths in these homes, unlike New York, where the attorney general found that the Cuomo administration had undercounted fatalities by the thousands.

But Collins questioned that claim, citing Spotlight PA reporting from September 2020 that found weekly reports released by the state health department were consistently missing death and case data for more than 100 of the state’s 693 nursing homes.
……

By September, more than six months since the first COVID-19 case in Pennsylvania, problems with the data had not been corrected. With many facilities still closed to visitors, advocates for nursing home residents and families said that there were few ways for families to know what was going on inside facilities and to monitor outbreaks.

Data related to a deadly outbreak at one Lehigh County facility was not included in the reports until August — after 80 residents had died, one of the highest death tolls in a nursing home in the state.
Those of us who live in Pennsylvania know all about Dr.Rachel Levine. Unfortunately we don’t have a weather girl” like Janice Dean.

The news comes as Levine, the nation’s first openly transgender health secretary, comes under fire over the department’s handling of nursing homes — particularly a March guidance that essentially instructed senior living facilities to accept patients who were diagnosed with the coronavirus.

The guidance stated:

Nursing care facilities must continue to accept new admissions and receive readmissions for current residents who have been discharged from the hospital who are stable to alleviate the increasing burden in the acute care settings. This may include stable patients who have had the COVID-19 virus.

Nearly 70 percent of the state’s coronavirus-related deaths — 2,896 of 4,218 — are connected to nursing home facilities.

It was revealed this week that Levine removed his 95-year-old mother from such a facility during the pandemic.

Pennsylvania AG opens criminal probes into nursing homes …

Nursing home deaths account for more than two-thirds of the state’s death toll. … into several nursing homes amid a coronavirus outbreak that has killed 2,600.

 

Protesters call for Pennsylvania health secretary to step down

The rally Monday was organized by state Sen. Doug Mastriano, who says Dr. Rachel Levine hasn’t properly protected the state’s vulnerable older population.

 

Let’s meet the mastermind behind this:

Meet the Transgender Doctor Leading Pennsylvania’s COVID-19 Response

She thinks she is the role model for allowing kids without parental consent change their bodies forever..

Rachel Levine discusses role model status.

 

 

Other than this all is well in the swamp.

Fauci uncensored – Which version of his opinions are we to believe?

 

Fauci flushes with the excitement of his resurrection to be front man for Biden’s covid response.

Science, he says… Science will rule. Let’s take a look at a couple of clips from yesterday’s roll out of Fauci and team.

The last clip has to be the best summary of the infamous 80 year old Dr. Fauci’s various positions taken regarding the “best” Covid policies.

No wonder the Donald got fed up with him and moved on to others and gave up on the daily wisdom of Fauci.

Oh the excitement of being center stage once more. Oh joy!

Let’s do the setup with a couple of clips.

 

Reporter once again confronts Dr. Fauci with a hard hitting question. Fauci swoons with excitement… after all he takes no pleasure in what he is about to say….

 

 

 

Now the punchline. We discover the emperor is wearing no clothes……of course no reporter will ask him about his movable opinions on the matter and why it no doubt drove Trump nuts and left Trump with the bag. Why Fauci was relegated to the third string in the end. (I can only hope this tweet stays up….here is hoping.)

 

 

Looks like Biden and Fauci will be the perfect match. Biden announces with a scowl and proudly indeed that the goal is a million shots of vaccine in arms in a 100 days. Unfortunately Biden’s new Covid savant Fauci failed to tell him that it is about where we are now.

Twitter is ablaze that Biden finally has a plan for distribution.

a quote:

“Last week, we had two days when we vaccinated one million people a day

Why is Biden planning to SLOW DOWN vaccination? we were already on track to EXCEED 100 million doses in 100 days. Biden‘s target should be 200 million will Dear Leader media call him on this scam?

Cuomo: I’ll Fine Doctors Up To $1 Million If They Vaccinate Someone Who Isn’t Eligible Yet

 

What was promised regarding the distribution of the vaccine is becoming a mess. Fauci insists that half the vaccine has to be held back in order for the second shot to be available. Meanwhile apparently the expiration date is an issue along with keeping the vaccine at an unbelievable cold temperature for one of the vaccines.

But I do know, threatening physicians is not the way to go.  All seniors should be getting this. They are the ones dying.

Hot Air put together an interesting post on the topic. I suggest having at it:

 

Just one third of the total doses distributed to New York has been administered so far. A mere 1.2 percent of the state population has received the jab since mid-December. America is jogging along on vaccinations at a moment when the virus, propelled by its more contagious new variant, is beginning to sprint.

We’re only a few weeks into this and yet the calculus has already begun to shift from making sure that rules of prioritization are strictly followed to getting as many doses into arms as quickly as possible in order to catch up to the virus and slow transmission, prioritization be damned.

In other words, true to the form he displayed last spring, Cuomo is already a step behind. By threatening doctors to stick rigidly to the prioritization scheme, he’s destined to slow down the vaccination process at a moment when it desperately needs to speed up.

This series of tweets started circulating online last night as a counterpoint to Cuomo’s logic. Israel is the smash success of the global vaccination process so far for complicated reasons, but a not so complicated one is that they understand their top goal is to get the greatest possible number vaccinated ASAP. Prioritzation is a secondary concern.

….

In New York those nurses would face a $1 million fine from Darth Cuomo, all because they smartly decided to distribute an expiring vaccine rather than let it go to waste. The vaccinated pizza guy is now one less vector of transmission for the virus, yet Cuomo might revoke someone’s license for making it happen.

 

 

Read more at Hot Air

The government at work. The swamp always claims its victims,

Vaccine payouts for injuries and deaths $4.4 billion by U.S. Government

 

Vaccine makers are IMMUNE from liability!

REMINDER: National Vaccine Injury Compensation Program’s payouts to vaccine-injured total more than $4.4 billion since 1989. Here are petition & compensation data. Will minors get a chance to review before granting “informed consent!?

https://www.hrsa.gov/vaccine-compensation/data/index.html

Covid mRNA vaccines are totally untested in general population. Mainstream scientists & others are asking serious questions about whether they will INCREASE long-term risk of autoimmune disease.The effects on women’s fertility. The discussion is widespread on social media despite censors.

Big Pharma can’t say how long alleged protection of COVID-19 vaccines will last. Can’t tell you about synergistic effects with other vaccines. Can’t tell you about long-term side effects.

 

 

 

Do your own homework. Here are links to the Pfizer and Moderna clinical trial protocols. How can you give if you DON’T inform yourselves? modernatx.com/sites/default/

pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C45910

Bonus flashback post not to be missed:

If you want to know how a Biden/Obama administration has in mind regarding Covid, check out what they had in mind in 2014. This was at a time of an Ebola scare:

An executive order signed by President Obama at the end of July also allows for the “apprehension, detention, or conditional release of individuals to prevent the introduction, transmission, or spread of suspected communicable diseases.”

The executive order, titled Revised List of Quarantinable Communicable Diseases, amends executive order 13295, passed by George W. Bush in April 2003, which allows for the, “apprehension, detention, or conditional release of individuals to prevent the introduction, transmission, or spread of suspected communicable diseases.”

The amendment signed by Obama replaces subsection (b) of the original Bush executive order which referred only to SARS.

In addition,  Model state emergency public healthcare act     public health authorities and governors would be given expanded police powers to seize control of communications devices, public and private property, as well as a host of other draconian measures in the event of a public health emergency.

Other than that, all is well in the swamp.

Melinda Gates Is ‘Incredibly Disappointed’ That Americans Will Get the Vaccine First

Billionaire globalist Melinda Gates is “incredibly disappointed” that President Trump has put Americans first in line to receive the Wuhan coronavirus vaccine.

Melinda Gates believes the senile old fool Biden will end the dark months of Trump. Gates said she was looking forward to Joe Biden becoming president and bringing his “global leadership” to the White House before warning of “dark months” to come while Trump remains in office. Yes, welcome globalists to a Biden administration.

Well folks…..guess who paid for this vaccine with billions of buckeroos?

Gates, co-chair of the Bill and Melinda Gates Foundation, told CNN’s Poppy Harlow that it’s America’s and other high-income countries’ responsibility to make sure impoverished nations get access to the vaccine just as quickly as everyone else.

“Everybody needs this vaccine,” complained Gates. “If we only get it to the high-income countries, this disease is going to bounce around. We’re going to see twice as many deaths. And our recovery of our economies is going to be much slower than if we get the vaccine out to everybody.”

The only thing consistent with these globalists is they always want America to come last.

“I just knew it was coming and I was just incredibly disappointed,” Gates said about Trump’s America First executive order.

H/T: Town Hall

Sounds about right for Biden. He went to Europe and called America an embarrasment.

Other than that all is well in the swamp.

New York introduces bill mandating COVID vaccination – if you die or injured reimbursed

If injured or you die from the COVID-19 vaccine not to worry, you will be reimbursed by the federal government.

What happens if a person is injured by someone who is made immune under the Declaration?

As is typically the case under the PREP Act, persons with serious physical injury or death arising from the administration or use of a Covered Countermeasure can recover from the Countermeasures Injury Compensation Program.  This is a fund managed by the Health Resources and Services Administration

Even better? New York is thinking about giving it the full works. Mandatory vaccination possibly coming your way.

New Yorkers will no longer have to decide if they will receive a COVID-19 vaccine if a bill calling for a mandatory vaccine gets approved.

New York State Assemblywoman Linda Rosenthal, a Democrat who represents New York’s 67th Assembly District, quietly introduced a bill on Dec. 4 that would require “COVID-19 vaccine to be administered in accordance with the department of health’s COVID-19 vaccination administration program and mandates vaccination in certain situations.”

Rosenthal told WGRZ-TV the bill was “a protective health measure” that would “ensure that our residents are safe and protected against further spread.”

……

UPDATE: USA:

REMINDER: National Vaccine Injury Compensation Program’s payouts to vaccine-injured total more than $4.4 billion since 1989. Here are petition & compensation data. Will minors get a chance to review before granting “informed consent!?”

https://hrsa.gov/vaccine-compensation/data/index.html
/33

In the UK, the government has already begun vaccinating its citizens. The country became the first to approve Pfizer’s COVID-19 vaccine, grant it an emergency approval, and give it immunity from civil lawsuits, under Regulation 345 of the Human Medicines Regulations (pdf) of 2012.

According to a press release from the UK government, individuals experiencing severe adverse reactions that cause them to be “severely disabled as a result of taking a COVID-19 vaccine” are able to “access financial assistance through the Vaccine Damage Payments Scheme (VDPS).”

……

In the United States, vaccines granted emergency authorization are also not liable for the harm they may cause. The Public Readiness and Emergency Preparedness (PREP) Act (pdf) allows the Secretary of the Department of Health and Human Services to issue a PREP Act declaration giving liability immunity to “entities and individuals involved in the development, manufacturing, testing, distribution, administration, and use of such countermeasures.”

People injured by vaccines that have been granted emergency authorization have one year after receiving a vaccine to file a claim and prove their injury under the Countermeasures Injury Compensation Program, a federal government program established as a result of the PREP Act. Certain survivors of people who died from those vaccines also qualify. Learn more about How to File for CICP benefits.

Will the Countermeasures Injury Compensation Program provide compensation to individuals injured by COVID-19 vaccines?

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration.  The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures. The PREP Act declaration for medical countermeasures against COVID-19 states that the covered countermeasures are:

  • any antiviral, any other drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine, used
    • to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or
    • to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause; or
  • any device used in the administration of any such product, and all components and constituent materials of any such product.

Covered Countermeasures must be ”qualified pandemic or epidemic products,” or ”security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act, or a respiratory protective device approved by National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary of the Department of Health and Human Services determines to be a priority for use during a public health emergency declared under section 319 of the Public Health Service Act.

The PREP Act declaration for COVID-19 (pdf) went into effect on Feb. 4.

If the New York mandatory COVID-19 vaccine bill is approved, the bill will take effect immediately.

Read more Zero Hedge

Of possible interest if you missed yesterday’s post which includes vaccines and what your government can do to you:

The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

Other than that, all is well in the swamp.

The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

The COVID vaccine arrival as well as Biden’s choice for his nomination of California Attorney General Xavier Becerra to lead the Health and Human Services Department makes it imperative that we give the Cures Act a review. There have been administrative tweaks to the bill but section 3023 remains.

Jan 31, 2020 — The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. (Link) 21st Century Cures Act

The Cures Act was passed in the tail end of 2016. Today I focus on Section 3023, 3024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this?

Earlier I posted Trump hogties the EPA, will he stop their illegal human medical experiments? This is why you should care. But let me not get ahead of myself. I include a video.

A year and a half after the original bill left the House of Representatives, the much-discussed and highly anticipated 21st Century Cures Act became law on December 13, 2016. The legislation went through more than a few changes in those seventeen months; it expanded from four sections to twenty-five and from 362 pages to 966. Informed Consent Waiver or Alteration for Clinical Investigations

The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.

The law sets two requirements for waiving or altering informed consent:

  1. The research must pose no more than minimal risk to participants; and
  2. Other measures to protect study volunteers must be in place.

The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.

From Science Blogs:

Title:The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. (Well worth the full  read.)

Worse, the bill undermines informed consent, as I discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject.

Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”

As Merrill Goozner put it and I agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk.

Well worth a good look. Our lives may depend on it. An excellent review of the bill and the ramifications.

This is a B-ville repost done in March of 2017:

The Cures Act – No longer is ‘Informed Consent’ required for some medical experiments

I am not sure I for one want the Biden administration in charge of:

Human research subject protections

The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order “to reduce regulatory duplication and unnecessary delays” and “modernize such provisions in the context of multisite and cooperative research projects.” – Wikipedia,

Unfortunately the Quorum links are no longer available.

Other than this all is well in the swamp.

Florida will require COVID test methods for positive results

 

Finally a State is going to require reporting of COVID PCR lab results and how they determine ‘positive’. Kudo’s to Governor Desantis in trying to bring some sanity to the so called ‘science’ in lab testing.

Controversy abounds regarding lab testing. Few seem willing to investigate. While Fauci keeps wanting to take the stage with his mask controversy and lock downs, how about some real science?

Zero Hedge:

All of which is background for an intriguing decision made by Florida’s Department of Health (and signed off on by Florida’s Republican Governor Ron deSantis).

For the first time in the history of the pandemic, a state will require that all labs in the state report the critical “cycle threshold” level of every COVID-19 test they perform.

All positive, negative and indeterminate COVID-19 laboratory results must be reported to FDOH via electronic laboratory reporting or by fax immediately. This includes all COVID-19 test types – polymerase chain reaction (PCR), other RNA, antigen and antibody results.

Cycle threshold (CT) values and their reference ranges, as applicable, must be reported by laboratories to FDOH via electronic laboratory reporting or by fax immediately.

Zero Hedge has detailed the controversy surrounding America’s COVID “casedemic” and the misleading results of the PCR test and its amplification procedure in great detail over the past few months.

As a reminder, “cycle thresholds” (Ct) are the level at which widely used polymerase chain reaction (PCR) test can detect a sample of the COVID-19 virus. The higher the number of cycles, the lower the amount of viral load in the sample; the lower the cycles, the more prevalent the virus was in the original sample.

Here are a few headlines from those experts and scientific studies:

1. Experts compiled three datasets with officials from the states of Massachusetts, New York and Nevada that conclude:“Up to 90% of the people who tested positive did not carry a virus.”

2. The Wadworth Center, a New York State laboratory, analyzed the results of its July tests at the request of the NYT: 794 positive tests with a Ct of 40: “With a Ct threshold of 35, approximately half of these PCR tests would no longer be considered positive,” said the NYT. “And about 70% would no longer be considered positive with a Ct of 30! “

3. An appeals court in Portugal has ruled that the PCR process is not a reliable test for Sars-Cov-2, and therefore any enforced quarantine based on those test results is unlawful.

4. A new study from the Infectious Diseases Society of America, found that at 25 cycles of amplification, 70% of PCR test “positives” are not “cases” since the virus cannot be cultured, it’s dead. And by 35: 97% of the positives are non-clinical.

5. PCR is not testing for disease, it’s testing for a specific RNA pattern and this is the key pivot. When you crank it up to 25, 70% of the positive results are not really “positives” in any clinical sense, since it cannot make you or anyone else sick

So, in summary, with regard to our current “casedemic”, positive tests as they are counted today do not indicate a “case” of anything. They indicate that viral RNA was found in a nasal swab. It may be enough to make you sick, but according to the New York Times and their experts, probably won’t. And certainly not sufficient replication of the virus to make anyone else sick. But you will be sent home for ten days anyway, even if you never have a sniffle. And this is the number the media breathlessly reports… and is used to fearmonger mask mandates and lockdowns nationwide…

Read more at Zero Hedge

A refresher – the attacks are on Trump but what did Fauci have to say?

Other than that all is well in the swamp.

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