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What Happened to Real Cow’s Milk???

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Frankenfoods v2: Exploiting the Bioequivalence Principle

By ANH-USAOn 7 Comments
Frankenfoods v2: Exploiting the Bioequivalence Principle
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Powerful forces are trying to shift our food system away from the soil-based farming systems and towards genetically engineered, lab-grown food. We can’t let them succeed.

THE TOPLINE

  • Bored Cow, a cow and animal free whey-containing, cultured milk, is one of a growing number of foods being produced through synthetic biology and ‘precision fermentation’—the health risks of which are largely unknown.
  • We’re told products like Bored Cow are fine—even desirable—because they’re biologically the same as their natural counterparts without the toll on the environment purportedly caused by livestock and dairy farming.
  • Yet the evidence indicates that these products are far from biologically equivalent, but regulators don’t seem to care.

Got Milk GE-yeast-fermented-whey-protein drink?

You may have heard about the new “animal-free dairy milk” called Bored Cow. It’s being billed as a more animal and environmentally friendly option to traditional milk that comes from a ruminant’s udders. It all sounds great until you dig a bit deeper to learn that it is produced using synthetic biology (synbio), using genetically engineered (GE) yeast that is then put into a so-called ‘precision fermentation’ system. While the whey protein in it is the same as that found in cow’s milk, that’s only a small part of the overall story. Emerging data from some scientists, like John Fagan from the Health Research Institute (HRI), says the fermentation isn’t as precise as claimed, and there’s a lot of other compounds in the milk, some of which have never been recorded by science before. That might mean that drinking Bored Cow ‘milk’ on a daily basis could have unknown and potentially dangerous human health implications. This might just be one product, but it matters because powerful special interests are working to make synbio the tech platform of our food system moving forward—where farms are replaced with fermentation tanks—in the name of protecting the environment.

What’s happening here is an effort to get consumers to believe they can enjoy all the flavor, mouth feel, and nutrition of real cow’s milk…without the involvement of any cows (hence the “Bored Cow” name). Bored Cow is made with whey protein produced through a process called “precision fermentation,” a form of synbio. This involves taking a gene for whey protein and inserting it into a GE yeast. The yeast is put into fermentation tanks with other nutrients to help it grow. At the end the GE yeast is supposed to be filtered out, leaving only the milk protein. Bored Cow takes this protein and adds vitamins, minerals, and other ingredients to mimic the taste, consistency, and nutritional content of real cow’s milk.

Far from ‘bioequivalent’

The marketing hype behind Bored Cow starts falling apart when you learn that it’s not even close to being equivalent to real milk from pasture. HRI’s independent testing found 92 unknown compounds in this synbio milk. Fagan, HRI’s chief scientist, said these compounds are “completely novel to our food…They are nutritional dark matter.”

The FDA must be on top of this, right? Wrong. Bored Cow has not undergone safety testing at the FDA. Perfect Day, the manufacturer of the synbio whey protein, determined it was “generally recognized as safe” (GRAS) and voluntarily notified the FDA of this determination; in response the FDA said it had no questions. Given how rife the GRAS process is with conflicts of interest, this is akin to taking the company’s word for it that its novel synbio whey protein is safe.

Nor is it very likely that Bored Cow is nutritionally equivalent to real milk. Just as meat is more than just protein, milk is far more than a simple combination of whey and various vitamins and minerals. Milkfat contains 400 different fatty acids. Milk has two types of proteins, whey and casein—and there are several different types of these two proteins contained in milk, and a whole bundle of other compounds like lactoferrin and bioactive peptides that help prime the immune system.

Does synbio milk have this nutritional complexity? It doesn’t seem like it, as casein, to use just one example, which comprises 80 percent of the protein in cow’s milk, isn’t listed as an ingredient. Further, according to HRI’s tests, the amino acid composition of Bored Cow is “strikingly different” than that of milk.

Laws not fit to purpose

Bored Cow is representative of a whole new generation of GE foods that are in development, some of which we’ve written about previously. Older genetically modified (GM) foods were created by modifying the genome of a living plant by inserting, for example, an herbicide-resistance trait. That was nothing compared to what’s going on now. GE yeast or fungi are being used as little factories to manufacture food components that regulators say are biologically equivalent to their natural counterparts, so, they say, no additional testing is required because the foods have been shown to be safe through their long history of consumption. But, as we’ve seen, getting a yeast to make one protein found in milk, fermenting it, then adding nutrients, and slapping “milk” on the label doesn’t make it milk. Nor, for that matter, is lab-grown meat biologically equivalent to pasture-raised meat.

And herein lies the problem. The entire framework for dealing with genetically engineered foods in the US is fundamentally broken. That’s because the federal government decided decades ago that the final product is all that matters, not the process used to create that product. This was codified in the 1986 Coordinated Framework for the Regulation of Biotechnology, which was updated in 1992 and again in 2017. Astoundingly, it wasn’t updated to install more robust safety measures to protect Americans from new and previously unthinkable forms of food. It was updated in large part to remove or mitigate “unnecessary costs and burdens” that “limit the ability of technology developers” to “navigate the regulatory process” which also “hamper economic growth, innovation, and competitiveness.” That is, the Framework was updated to make it easier for the biotech industry to ger their frankenfoods onto our dinner plates!

We’re worried that what’s coming are further “updates” to this framework that allow GE foods and those developed using synbio technologies to be considered “bioequivalent” to their natural counterparts—in essence, drinking the lab-grown food industry’s Kool-Aid. If regulators determine that synbio milk is equivalent to real milk, will consumers be allowed to make their own choices, or will we be sold out as we were with the sham GMO labeling law that allowed companies to hide the GM contents of their food in scannable codes?

Some countries are already moving in that direction: Costa Rica just adopted new regulations which treat a wide-range of gene edited products as equivalent to conventionally-bred products. This is something we have to keep a keen eye on.

The advent of lab-grown meat, plant-based meat, and products like Bored Cow show how inadequate our current laws are in dealing with these foods. Of course it matters how these foods are made! CRISPR, the gene-editing technology, is known to produce unintended outcomes. What evidence is there that eating food grown in laboratories from genetically modified yeast—food that is significantly different than the food we have evolved to eat over human history—is safe, much less healthy?

Put simply, the fake meat and milk synbio manufacturers are exploiting old rules never intended for synbio products so they can escape doing any safety testing before their products hit the market. They’re using all-too-familiar revolving doors with the FDA to get their way, and they want to deceive us into thinking they’re saving the planet from those nasty, carbon dioxide-producing animals while offering us foods that are as safe and healthy as those produced on real farms with the help of real animals—without any of it.

We’re watching these developments closely, and we’ll alert you as soon as we see an opportunity to take political action on this critical issue. In the meantime, please share this article widely, as we need a lot more awareness of how synbio makers are using the principle of ‘bioequivalence’ to get their questionable foods into our mouths.

from:    https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/

Pfizer Told 8 Months to Release “Vaccine” Data

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Judge Rejects FDA’s 75 Year Delay On Vax Data, Cuts To Just 8 Months

by Tyler Durden
Friday, Jan 07, 2022 – 06:11 AM

A federal judge has rejected a request by the FDA to produce just 500 pages per month of the data submitted by Pfizer to license its Covid-19 vaccine – and has ordered them to produce 55,000 pages per month. Assuming there are roughly 450,000 pages, that means it will take just over eight months for the world to see what’s under the hood.

Attorney Aaron Siri, who represents the plaintiff in the case, has provided this stunning update via his blog, Injecting Freedom:

On behalf of a client, my firm requested that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine.  The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents.

I am pleased to report that a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month!

This is a great win for transparency and removes one of the strangleholds federal “health” authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.

No person should ever be coerced to engage in an unwanted medical procedure.  And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead.  That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.

In ordering the release of the documents in a timely manner, the Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities.  He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

The following is the full text of the Judge’s order, a copy of which is also available here.

UNITED STATES DISTRICT COURT

PHMPT, Plaintiff v. FDA, Defendant, No. 4:21-cv-1058-P

ORDER

This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the Food and Drug Administration (“FDA”). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court’s consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.[1] See ECF Nos. 21, 34.

“Open government is fundamentally an American issue” – it is neither a Republican nor a Democrat issue.[2] As James Madison wrote, “[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.”[3] John F. Kennedy likewise recognized that “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”[4] And, particularly appropriate in this case, John McCain (correctly) noted that “[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public’s confidence in the government.”[5]

Echoing these sentiments, “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’” Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep’t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And “Congress has long recognized that ‘information is often useful only if it is timely’ and that, therefore ‘excessive delay by the agency in its response is often tantamount to denial.’” Open Soc’y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)). When needed, a court “may use its equitable powers to require an agency to process documents according to a court-imposed timeline.” Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance.

“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) (“[I]t is the compelling need for such public understanding that drives the urgency of the request.”). To that end, the Court further concludes that the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA’s concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284–85 (2nd Cir. 1991) (“[FOIA] emphasizes a preference for the fullest possible agency disclosure of such information consistent with a responsible balancing of competing concerns . . . .”).

Accordingly, having considered the Parties’ arguments, filings in support, and the applicable law, the Court ORDERS that:

1. The FDA shall produce the “more than 12,000 pages” articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.

2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.

3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.

4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.[6]

SO ORDERED on this 6th day of January, 2022.

[1] Surprisingly, the FDA did not send an agency representative to the scheduling conference.

[2] 151 CONG. REC. S1521 (daily ed. Feb. 16, 2005) (statement of Sen. John Cornyn).

[3] Letter from James Madison to W.T. Barry (August 4, 1822), in 9 WRITINGS OF JAMES MADISON 103 (S. Hunt ed., 1910).

[4] John F. Kennedy, Remarks on the 20th Anniversary of the Voice of America (Feb. 26, 1962).

[5] America After 9/11: Freedom Preserved or Freedom Lost?: Hearing Before the S. Comm. on the Judiciary, 108th Cong. 302 (2003).

[6] Although the Court does not decide whether the FDA correctly denied Plaintiff’s request for expedited processing, the issue is not moot. Should the Parties seek to file motions for summary judgment, the Court will take up the issue then.

from:    https://www.zerohedge.com/covid-19/judge-rejects-fdas-75-year-delay-vax-data-cuts-8-months?utm_source=&utm_medium=email&utm_campaign=399

Where O-Where is Covid 19

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The non-existent virus; an explosive interview with Christine Massey

by Jon Rappoport

With a background in biostatistics, Christine Massey has been using Freedom of Information (FOIA) requests as a research tool, as a diamond drill, to unearth the truth about SARS-CoV-2. As in: Does the virus exist?

Her approach has yielded shocking results.

In a half-sane world, Christine’s work would win many awards, and rate far-reaching coverage. In the present world, more and more people, on their own, are waking up to her findings and completely revising their perception of the “pandemic.”

Here is my recent interview with the brilliant relentless Christine Massey:

Q: You and your colleagues have made many FOIA requests to public health agencies around the world. You’ve been asking for records that show the SARS-CoV-2 virus exists. How did you develop this approach?

A: In 2014, a lady in Edmonton submitted a freedom of information request to Health Canada asking for studies relating to the addition of hydrofluorosilisic acid (industrial waste fluoride acid) to public drinking water (water fluoridation). HealthCanada’s response indicated that they had no studies whatsoever to back up their claims that the practice is safe or effective.

A few years later, some high quality government-funded studies showed that common fluoride exposure levels during pregnancy are associated with lower IQs and increased ADHD symptoms in offspring. Nevertheless, dentists and the public health community continued to promote and defend the so-called “great public health achievement” of forcing this controversial preventative dental treatment onto entire communities, and were dismissive of those studies. So I used freedom of information requests to show that various institutions promoting and defending water fluoridation in Ontario, Alberta and Washington State could not provide or cite even one primary study indicating safety with respect to those outcomes.

So once I learned from people like David Crowe, Dr. Andrew Kaufman, Dr. Stefan Lanka and Dr. Thomas Cowan that the alleged [COVID] virus had never been isolated (purified) from a patient sample and then characterized, sequenced and studied with controlled experiments, and thus had never been shown to exist, I realized that freedom of information (FOI) requests could be used to verify their claims.

Most people are not going to take the time to check all of the so-called “virus isolation” studies for themselves, so FOIs were a way to 1) ensure that nothing had been overlooked, and 2) cut to the chase and back-up what these gentlemen [Kaufman, Cowan, Crowe, Lanka] were saying, if they were indeed correct.

So in May 2020 I began submitting FOI requests for any record held by the respective institution that describes the isolation/purification of the alleged “COVID-19 virus” from an unadulterated sample taken from a diseased patient, by anyone, anywhere on the planet.

Q: How many public health and government agencies have you queried with FOIA requests?

A: I have personally queried and received responses from 22 Canadian institutions. These are public health institutions, universities that claim to have “isolated the virus”, and 3 police services – due to their enforcement of “COVID-19” restrictions. I have also personally received responses from several institutions outside of Canada including the U.S. Centers for Disease Control and Prevention and Anthony Fauci’s National Institute of Allergy and Infectious Diseases (NIAID). I await responses from a number of additional institutions.

Many people around the world have obtained responses to the same/similar, or related, [FOIA] requests, from institutions in their own countries. One person who has done a lot of work on this in New Zealand and other countries is my colleague Michael S. Also a fellow named Marc Horn obtained many in the UK. A handful of other people obtained several responses, and lots of people have obtained 1 or 2.

I have been compiling all of the responses that are sent to me on my FOI page, and as I type this (October 4, 2021) we have FOI responses from 104 institutions in well over 20 countries all relating to the purification/existence of the alleged virus. Additionally, there are court documents from South Africa and Portugal. In total, 110 instructions are represented at this moment on my website. There are FOI responses from more institutions that I haven’t had a chance to upload yet.

Q: How would you characterize the replies you’ve gotten from these agencies?

A: Every institution without exception has failed to provide or cite even 1 record describing purification of the alleged virus from even 1 patient sample.

Twenty-one of the 22 Canadian institutions admitted flat out that they have no such records (as required by the Canadian legislation). Many institutions outside Canada have admitted the same, including the CDC (November 2, 2020), Australia’s Department of Health, New Zealand’s Ministry of Health, the UK Department of Health and Social Care…

And in some cases, silly excuses were provided. For example, the Norwegian Directorate of Health’s response was that they do not own, store or control documents with information about patients. Public Health Wales told Dr. Janet Menage that they have not produced any such records, and that while they would normally be willing to point her towards records that are in the public domain it would be too difficult in this case.

Brazil’s FDA-like injection-approver, the Health Regulatory Agency (Anvisa), told Marcella Picone that they have no record of virus purification and are not required to by law, thus it is (in their minds) not their obligation to make sure that the virus actually exists.

Q: What is the exact text of your FOIA requests?

The text has varied somewhat over time. For example, in the beginning I used the word “isolation”. But since that term gets abused so badly by virologists, I now stick to “purification”.

In all requests I specified exactly what I meant by isolation/purification (separation of the alleged virus from everything else), and that the purified particles should come directly from a sample taken from a diseased human where the patient sample was not first adulterated with any other source of genetic material (i.e. the monkey kidney cells aka Vero cells and the fetal bovine serum that are typically used in the bogus “virus isolation” studies).

I always clarified that I was not requesting records where researchers failed to purify the alleged virus and instead cultured something and/or performed a PCR test and/or sequenced something. I also clarified that I was requesting records authored by anyone, anywhere – not simply records that were created by the institution in question. And I requested citations for any record of purification that is held by the institution but already available to the public elsewhere.

The latest iteration [of the FOIA request] is posted on a page of my website where I encourage others to submit requests to institutions in their own country: Template for “SARS-COV-2 isolation” FOI requests.

Q: These agencies are all saying they have no records proving SARS-CoV-2 exists, but at the same time some of these agencies sponsor and fund studies that claim the virus does exist. How do you account for this contradiction?

I will address this by way of an example.

The Public Health Agency of Canada (PHAC) is the only Canadian institution that failed to provide a straightforward “no records” response thus far. Instead, they provided me with what they pretended were responsive records.

The records consisted of some emails, and a study by Bullard et al. that was supported by PHAC and their National Microbiology Laboratory, and by Manitoba Health and Manitoba’s Cadham Provincial Laboratory.

Neither the study nor the emails describe purification of the alleged virus from a patient sample or from anything else. The word “isolate” (or “isolation” / “purify” / “purification”) does not even appear, except in the study manuscript in the context of isolating people, not a virus.

…in the Materials And Methods section we find that these researchers performed PCR “tests” for a portion of the E gene sequence (not a virus), and they incubated patient samples (not a virus) on Vero cells (monkey kidney cells) supplemented with fetal bovine serum, penicillin/streptomycin, and amphotericin B, and they monitored for harm to the monkey cells.

No virus was looked for in, or purified from, the patient samples. No control groups of any kind were implemented in the monkey cell procedures. No virus was required or shown to be involved anywhere in the study, but “it” was blamed for any harm to the monkey cells and “it” was referred to repeatedly throughout the study (I counted 26 instances).

Nevertheless, this was the sole paper provided by the Public Health Agency of Canada.

And although the researchers did not claim to have “isolated” the alleged virus in this paper, they performed the same sort of monkey business / cell culture procedure that is passed off as “virus isolation” by virologists in country after country. (Because virology is not a science.)

…Note the admission in the [study] Abstract: “RT-PCR detects RNA, not infectious virus”.

…So I wrote back to the Public Health Agency of Canada and advised the that none of the records they provided me actually describe separation of the alleged virus from everything else in a patient sample, and that I require an accurate response indicating that they have no responsive records.

In their revised response, the Agency insisted that the gold standard assay used to determine the presence of intact virus in patient samples is visible cytopathic [cell-killing] effects on cells in a cell culture, and that “PCR further confirms that intact virus is present”.

…As you have pointed out to your readers again and again: No one has isolated/purified “the virus”. They simply assume that patient samples contain “it” (based on meaningless PCR tests). They adulterate patient samples with genetic material and toxic drugs, starve the cells, then irrationally blame “the virus” for harm to the cells. They point to something that has never been purified, characterized, sequenced or studied scientifically, in a cell culture and insist “that’s the virus”. They fabricate the “genomes” from zillions of sequences detected in a soup. It’s all wild speculation and assumptions, zero science.

So the people responsible for the blatantly fraudulent claims made by these institutions are either wildly incompetent or intentionally lying.

—end of interview—

To bolster Christine’s final comments, these agencies will respond to FOIA requests with: “we have no records of virus purification”—and then sponsor studies that claim the virus HAS BEEN purified and discovered, because…

The standards for purifying the virus in the studies are no standards at all. They’re entirely irrational.

However, because Christine is very precise and accurate in her FOIA requests, when it comes to what purification means, the agencies are compelled to reply…

“Well, in THAT case, we have no records of virus purification…”

Meaning: There are no records showing the virus has been isolated; there are no records showing the virus exists.

from:    https://blog.nomorefakenews.com/2021/10/07/the-non-existent-virus-explosive-interview-with-christine-massey/

“THEY” Do Not Want an Effective and Inexpensive Treatment -No $$$ For Them

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An Effective COVID Treatment the Media Continues to Besmirch

By Steven Hatfill

August 04, 2020

An Effective COVID Treatment the Media Continues to Besmirch
(AP Photo/Rafiq Maqbool)

On Friday, July 31, in a column ostensibly dealing with health care “misinformation,” Washington Post media critic Margaret Sullivan opened by lambasting “fringe doctors spouting dangerous falsehoods about hydroxychloroquine as a COVID-19 wonder cure.”

Actually, it was Sullivan who was spouting dangerous falsehoods about this drug, something the Washington Post and much of the rest of the media have been doing for months. On May 15, the Post offered a stark warning to any Americans who may have taken hope in a possible therapy for COVID-19. In the newspaper’s telling, there was nothing unambiguous about the science — or the politics — of hydroxychloroquine: “Drug promoted by Trump as coronavirus game-changer increasingly linked to deaths,” blared the headline. Written by three Post staff writers, the story asserted that the effectiveness of hydroxychloroquine in treating COVID-19 is scant and that the drug is inherently unsafe.

This claim is nonsense

Biased against the use of hydroxychloroquine for COVID-19 — and the Washington Post is hardly alone — the paper described an April 21, 2020, drug study on U.S. Veterans Affairs patients hospitalized with the illness. It found a high death rate in patients taking the drug hydroxychloroquine. But this was a flawed study with a small sample, the main flaw being that the drug was given to the sickest patients who were already dying because of their age and severe pre-existing conditions. This study was quickly debunked. It had been posted on a non-peer-reviewed medical archive that specifically warns that studies posted on its website should not be reported in the media as established information.

Yet, the Post and countless other news outlets did just the opposite, making repeated claims that hydroxychloroquine was ineffective and caused serious cardiac problems. Nowhere was there any mention of the fact that COVID-19 damages the heart during infection, sometimes causing irregular and sometimes fatal heart rhythms in patients not taking the drug.

To a media unrelentingly hostile to Donald Trump, this meant that the president could be portrayed as recklessly promoting the use of a “dangerous” drug. Ignoring the refutation of the VA study in its May 15 article, the Washington Post cited a Brazil study published on April 24 in which a COVID trial using chloroquine (a related but different drug than hydroxychloroquine) was stopped because 11 patients treated with it died. The reporters never mentioned another problem with that study: The Brazilian doctors were giving their patients lethal cumulative doses of the drug.

On and on it has gone since then, in a circle of self-reinforcing commentary. Following the news that Trump was taking the drug himself, opinion hosts on cable news channels launched continual attacks on both hydroxychloroquine and the president. “This will kill you!” Fox News Channel’s Neil Cavuto exclaimed. “The president of the United States just acknowledge that he is taking hydroxychloroquine, a drug that [was] meant really to treat malaria and lupus.”

Washington Post reporters Ariana Cha and Laurie McGinley were back again on May 22, with a new article shouting out the new supposed news: “Antimalarial drug touted by President Trump is linked to increased risk of death in coronavirus patients, study says.” The media uproar this time was based on a large study just published in the Lancet. There was just one problem. The Lancet paper was fraudulent and it was quickly retracted.

However, the damage from the biased media storm was done and it was long-lasting. Continuing patient enrollment needed for early-use clinical trials of hydroxychloroquine dried up within a week. Patients were afraid to take the drug, doctors became afraid to prescribe it, pharmacies refused to fill prescriptions, and in a rush of incompetent analysis and non-existent senior leadership, the FDA revoked its Emergency Use Authorization for the drug.

So what is the real story on hydroxychloroquine? Here, briefly, is what we know:

When the COVID-19 pandemic began, a search was made for suitable antiviral therapies to use as treatment until a vaccine could be produced. One drug, hydroxychloroquine, was found to be the most effective and safe for use against the virus. Federal funds were used for clinical trials of it, but there was no guidance from Dr. Anthony Fauci or the NIH Treatment Guidelines Panel on what role the drug would play in the national pandemic response. Fauci seemed to be unaware that there actually was a national pandemic plan for respiratory viruses.

Following a careful regimen developed by doctors in France, some knowledgeable practicing U.S. physicians began prescribing hydroxychloroquine to patients still in the early phase of COVID infection. Its effects seemed dramatic. Patients still became sick, but for the most part they avoided hospitalization. In contrast — and in error — the NIH-funded studies somehow became focused on giving hydroxychloroquine to late-presenting hospitalized patients. This was in spite of the fact that unlike the drug’s early use in ambulatory patients, there was no real data to support the drug’s use in more severe hospitalized patients.

By April, it was clear that roughly seven days from the time of the first onset of symptoms, a COVID-19 infection could sometimes progress into a more radical late phase of severe disease with inflammation of the blood vessels in the body and immune system over-reactions. Many patients developed blood clots in their lungs and needed mechanical ventilation. Some needed kidney dialysis. In light of this pathological carnage, no antiviral drug could be expected to show much of an effect during this severe second stage of COVID.

On April 6, 2020, an international team of medical experts published an extensive study of hydroxychloroquine in more than 130,000 patients with connective tissue disorders. They reaffirmed that hydroxychloroquine was a safe drug with no serious side effects. The drug could safely be given to pregnant women and breast-feeding mothers. Consequently, countries such as China, Turkey, South Korea, India, Morocco, Algeria, and others began to use hydroxychloroquine widely and early in their national pandemic response. Doctors overseas were safely prescribing the drug based on clinical signs and symptoms because widespread testing was not available.

However, the NIH promoted a much different strategy for the United States. The “Fauci Strategy” was to keep early infected patients quarantined at home without treatment until they developed a shortness of breath and had to be admitted to a hospital. Then they would they be given hydroxychloroquine. The Food and Drug Administration cluelessly agreed to this doctrine and it stated in its hydroxychloroquine Emergency Use Authorization (EUA) that “hospitalized patients were likely to have a greater prospect of benefit (compared to ambulatory patients with mild illness).”

In reality just the opposite was true. This was a tragic mistake by Fauci and FDA Commissioner Dr. Stephen Hahn and it was a mistake that would cost the lives of thousands of Americans in the days to come.

At the same time, accumulating data showed remarkable results if hydroxychloroquine were given to patients early, during a seven-day window from the time of first symptom onset. If given during this window, most infections did not progress into the severe, lethal second stage of the disease. Patients still got sick, but they avoided hospitalization or the later transfer to an intensive care unit. In mid-April a high-level memo was sent to the FDA alerting them to the fact that the best use for hydroxychloroquine was for its early use in still ambulatory COVID patients. These patients were quarantined at home but were not short of breath and did not yet require supplemental oxygen and hospitalization.

Failing to understand that COVID-19 could be a two-stage disease process, the FDA ignored the memo and, as previously mentioned, it withdrew its EUA for hydroxychloroquine based on flawed studies and clinical trials that were applicable only to late-stage COVID patients.

By now, however, some countries had already implemented early, aggressive, outpatient community treatment with hydroxychloroquine and within weeks were able to minimize their COVID deaths and bring their national pandemic under some degree of control.

In countries such as Great Britain and the United States, where the “Fauci-Hahn Strategy” was followed, there was a much higher death rate and an ever-increasing number of cases. COVID patients in the U.S. would continue to be quarantined at home and left untreated until they developed shortness of breath. Then they would be admitted to the hospital and given hydroxychloroquine outside the narrow window for the drug’s maximum effectiveness.

In further contrast, countries that started out with the “Fauci-Hahn Doctrine” and then later shifted their policy towards aggressive outpatient hydroxychloroquine use, after a brief lag period also saw a stunning rapid reduction in COVID mortality and hospital admissions.

Finally, several nations that had started using an aggressive early-use outpatient policy for hydroxychloroquine, including France and Switzerland, stopped this practice when the WHO temporarily withdrew its support for the drug. Five days after the publication of the fake Lancet study and the resulting media onslaught, Swiss politicians banned hydroxychloroquine use in the country from May  27 until June 11, when it was quickly reinstated.

The consequences of suddenly stopping hydroxychloroquine can be seen by examining a graph of the Case Fatality Ratio Index (nrCFR) for Switzerland. This is derived by dividing the number of daily new COVID fatalities by the new cases resolved over a period with a seven-day moving average. Looking at the evolution curve of the CFR it can be seen that during the weeks preceding the ban on hydroxychloroquine, the nrCFR index fluctuated between 3% and 5%.

Following a lag of 13 days after stopping outpatient hydroxychloroquine use, the country’s COVID-19 deaths increased four-fold and the nrCFR index stayed elevated at the highest level it had been since early in the COVID pandemic, oscillating at over 10%-15%. Early outpatient hydroxychloroquine was restarted June 11 but the four-fold “wave of excess lethality” lasted until June 22, after which the nrCFR rapidly returned to its background value.

Here in our country, Fauci continued to ignore the ever accumulating and remarkable early-use data on hydroxychloroquine and he became focused on a new antiviral compound named remdesivir. This was an experimental drug that had to be given intravenously every day for five days. It was never suitable for major widespread outpatient or at-home use as part of a national pandemic plan. We now know now that remdesivir has no effect on overall COVID patient mortality and it costs thousands of dollars per patient.

Hydroxychloroquine, by contrast, costs 60 cents a tablet, it can be taken at home, it fits in with the national pandemic plan for respiratory viruses, and a course of therapy simply requires swallowing three tablets in the first 24 hours followed by one tablet every 12 hours for five days.

There are now 53 studies that show positive results of hydroxychloroquine in COVID infections. There are 14 global studies that show neutral or negative results — and 10 of them were of patients in very late stages of COVID-19, where no antiviral drug can be expected to have much effect. Of the remaining four studies, two come from the same University of Minnesota author. The other two are from the faulty Brazil paper, which should be retracted, and the fake Lancet paper, which was.

Millions of people are taking or have taken hydroxychloroquine in nations that have managed to get their national pandemic under some degree of control. Two recent, large, early-use clinical trials have been conducted by the Henry Ford Health System and at Mount Sinai showing a 51% and 47% lower mortality, respectively, in hospitalized patients given hydroxychloroquine. A recent study from Spain published on July 29, two days before Margaret Sullivan’s strafing of “fringe doctors,” shows a 66% reduction in COVID mortality in patients taking hydroxychloroquine. No serious side effects were reported in these studies and no epidemic of heartbeat abnormalities.

This is ground-shaking news. Why is it not being widely reported? Why is the American media trying to run the U.S. pandemic response with its own misinformation?

Steven Hatfill is a veteran virologist who helped establish the Rapid Hemorrhagic Fever Response Teams for the National Medical Disaster Unit in Kenya, Africa. He is an adjunct assistant professor in two departments at the George Washington University Medical Center where he teaches mass casualty medicine. He is principle author of the prophetic book “Three Seconds Until Midnight — Preparing for the Next Pandemic,” published by Amazon in 2019.

from:    https://www.realclearpolitics.com/articles/2020/08/04/an_effective_covid_treatment_the_media_continues_to_besmirch_143875.html

Stand Up For Personal Health Freedom

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Hydroxychloroquine, COVID, FDA; and Pharma and all its whores around the world

by Jon Rappoport

by Jon Rappoport

July 29, 2020

(To join our email list, click here.)

“We are talking about private contracts outside the scope of government. We’re talking about local barter, and the issuing of local currencies, the building of private money systems. During the Great Depression, many citizens looked around and said, ‘We still have land and food, we still have commodities. Nothing has changed here. We just have to invent a way to conduct commerce among ourselves.’ One estimate states that, during the Depression of the 1930s, there were 1500 private money systems across America.” (My notes for “The Underground”)

I have made my case concerning the fake pandemic. Many times now.

From the beginning—the failure to isolate, purify, or actually discover a novel coronavirus by correct procedures. The meaningless diagnostic tests and the meaningless case numbers. The propaganda. The use of “the virus” as a cover story obscuring high-level corporate and government crimes.

Of course, many people believe in the COVID-19 virus. And of these, some have been seeking treatments outside the bounds of government certification.

This is their right. They are exercising freedom in managing their own health. And so some of them are taking hydroxychloroquine (HCQ).

The FDA, which certifies all medical drugs as safe and effective, before they are released for public use, has not recommended HCQ for COVID treatment. It has banned the drug for that purpose, outside of hospitals and clinical trials.

The FDA‘s track record—which I’ve been documenting for the past 25 years—is a horror show. The first key review I became aware of was authored in 2000, by Dr. Barbara Starfield, and published on July 26th of that year, in the Journal of the American Medical Association. Starfield stated that, annually, FDA-approved medicines kill 106,000 Americans. That’s over a million Americans per decade. So relying on the FDA to decide whether HCQ is a useful drug is not a concession some Americans are willing to make.

Pharma and all its allies and minions and whores are focusing on a jackpot bonanza for COVID treatment: vaccines and new antiviral drugs. Pharma does not want competition. It definitely does not want to see a landscape in which all sorts of alternative treatments for COVID (or any purported disease) are rampant and free-wheeling.

We are seeing multiple censorship actions across platforms, when people, including doctors, speak positively about HCQ.

Fauci is very much in the pro-Pharma camp, of course. He and Gates want an RNA vaccine to come to market, by any means necessary. They also want antiviral drugs to dominate COVID treatment.

A very sharp reader spelled out the Pharma-anticipated future for these new (toxic) antiviral medicines. And not just for COVID. Up to now, there has been very little mainstream progress in getting drugs specifically designed to treat viruses into the marketplace. This is Pharma’s big opportunity. They envision a trillion-dollar operation that will elevate antivirals (for treating any viruses) to the level of, say, antibiotics, which are used against bacteria. COVID would simply be the first major “breakthrough.”

So we have a war going on. HCQ and other alternative modalities vs. vaccines and antivirals. Pharma does not want to lose this one. It would be disastrous.

I am not touting HCQ. I am putting it this way: if many people are convinced, or become convinced, that HCQ is a drug of choice, and if they believe it is helping them, then a major rebellion against Pharma and the FDA and its counterparts around the world takes off. It soars. And it spurs the use of other alternatives on which Pharma makes zero profits.

So-called natural health and alternative medicine have been booming since the 1980s. A new escalation would send very serious shock waves through the pharmaceutical industry.

Fauci is well aware of this. He is fronting for the industry in every possible way. Trump, with his statements favoring HCQ, has become a major threat in that regard.

When you see new reports of soaring COVID case numbers—a con which I’ve documented six ways from Sunday—you’re not only witnessing a planned strategy to maintain the war against the economy and therefore against billions of people whose lives are at stake; you’re also watching a justification for pushing antivirals and vaccines. For the benefit of Pharma.

The last thing the pharmaceutical industry wants to see is their own case-number con giving birth to wildcat outbreaks of health freedom. People leaving the nest. People going elsewhere for treatment.

Individuals making decisions about their own treatments—this is very serious business. People should look deeply before making choices. In the case of various HCQ protocols, they should consider: dosage levels; when in the course of illness the drug would be given (early or late); whether there is illness requiring treatment to begin with; whether people may have a heredity condition which could make HCQ perilous or even lethal—these are some of the relevant considerations.

The FDA and Pharma want to be the first and last word.

Life and Liberty say they are not the first and last word.

In that regard, there is another issue: licenses vs. contracts. The medical cartel, backed by governments, has established medical boards which grant licenses to practice medicine. These special persons, doctors, are handed the right to treat and cure diseases. This is an attempt to create a monopoly.

There is another avenue: private contracts. Here is the analogy I’ve used to describe this situation. Two adults, Joe and Fred, enter into an agreement. Joe says he has a health condition. He will be the patient. Fred will be the practitioner. Fred has a well on his property. Fred believes the water has a special healing quality. He will give some of it (or sell it) to Joe, who will drink it over the course of two weeks.

Both men, in their contract, agree that no legal liability will be attached to the outcome. They are both responsible. They are of sound mind. They don’t require government permission to sign or fulfill their contract.

That’s it in a nutshell.

Joe and Fred are operating on their own. They have that natural right. They also have the right to be wrong—in case the water treatment doesn’t work, or is harmful.

Of course, all sorts of meddlers will claim this arrangement is illegal and absurd. Meddlers always try to curb freedom. That’s their crusade in life. They can’t stand the idea of people making their own choices and decisions and then accepting the consequences.

I’m not saying governments will honor such contracts. Governments are prime meddlers. I’m saying these contracts (and not just in the arena of healing) stand outside governments. They are citizen-to-citizen. They are prior to government. They are intrinsically more real than government.

from:    https://blog.nomorefakenews.com/2020/07/30/hcq-covid-fda-and-pharma-and-all-its-whores/

Drugs, Efficacy, & Safety

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Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds

Date:
August 17, 2010
Source:
American Sociological Association

The pharmaceutical industry is a “market for lemons,” a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.

“Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. “Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”

Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.

According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, toxic side effects or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.

Light’s paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” is an institutional analysis of the pharmaceutical industry and how it works based on a range of independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the Food and Drug Administration, and Prescrire International.

The foundation for the paper is the work Light did for a forthcoming book he edited, titled ‘The Risk of Prescription Drugs,” which is scheduled for publication this fall by Columbia University Press.

In both his paper and his book, Light describes the “Risk Proliferation Syndrome” that is maximizing the number of patients exposed to new drugs that have relatively low efficacy and effectiveness but have greater risk of adverse side effects. Building on clinical trials designed to minimize evidence of harm and published literature that emphasizes a drug’s advantages, companies launch massive campaigns to sell it, when a controlled, limited launch would allow evidence to be gathered about the drug’s effects. Companies recruit leading clinicians to try using the drug for conditions other than those for which it is approved and to promote such off-label or unapproved uses. Physicians inadvertently become “double agents” — promoters of the new drug, yet trusted stewards of patients’ well-being, said Light. When patients complain of adverse reactions, studies show their doctors are likely to discount or dismiss them, according to Light.

Despite the extensive requirements for testing the efficacy and safety of each new drug, companies “swamp the regulator” with large numbers of incomplete, partial, substandard clinical trials, Light said. For example, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects, said Light.

“Just recently, major reports have come out about biased, poor trials for Avandia and Avastin,” Light said, who noted that orphan drugs are tested even less well.

“The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause,” Light said. The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published.

“A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs,” Light said. “We could also increase the percentage of new drugs that are really better for patients.”

The paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” was presented on Aug. 17 in Atlanta at the American Sociological Association’s 105th Annual Meeting.

Story Source:

Materials provided by American Sociological Association. Note: Content may be edited for style and length.

from:    https://www.sciencedaily.com/releases/2010/08/100817111825.htm

American Sociological Association. “Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds.” ScienceDaily. ScienceDaily, 17 August 2010. <www.sciencedaily.com/releases/2010/08/100817111825.htm>.

Drugs – Safety, Profitability, etc.

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Serious Risks And Few New Benefits From FDA-Approved Drugs

July 6, 2015 10.1377/hblog20150706.049097

Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices.

But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.

This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.

Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.

A Me-Too Business Model

Every drug has risks, so any drug considered for FDA approval should demonstrate clinical advantages that justify those risks. Yet public, independent advisory teams of physicians and pharmacists in several countries found over 90 percent of new drugs approved by the FDA and the European Medicines Agency (EMA) offer few or no advantages over existing drugs to offset their risks of serious harm.

Figure 1 shows the scorecard for 979 newly approved drugs over a 10-year span, based on detailed assessment of clinical benefits and risks by Prescrire, one of the world’s most distinguished, independent review bodies of physicians and pharmacists. (The exhibit focuses on France, a country whose consumer-oriented drug market features an array of products similar to the U.S.)

Figure 1. Few Clinical Advances in a Decade and Hundreds of Other Drugs Approved for Promotion

Light-Figure 1

Only two were breakthrough advances and fewer than 10 percent offered substantial clinical advantages over existing drugs. Yet approved drugs have a 20 percent risk of producing enough harm for regulators to add a serious warning or have them withdrawn.

Flooding the market with hundreds of minor variations on existing drugs and technically innovative but clinically inconsequential new drugs, appears to be the de facto hidden business model of drug companies. In spite of its primary charge to protect the public, the FDA criteria for approval encourage that business model. The main products of pharmaceutical research are scores of clinically minor drugs that win patent protection for high prices, with only a few clinically important advances like Sovaldi or Gleevec.

This business model works. Despite producing drugs with few clinical advantages and significant health risks, industry sales and profits have grown substantially, at public expense. Companies spend 2-3 times less on research than on marketing to convince physicians to prescribe these minor variations.

Industry figures show the public pays companies about six times R&D costs through high prices on drugs. According to a study by Consumer Reports, high costs to patients lead them to postpone visits to physicians, avoid medical tests, and be able unable to afford other, effective drugs. For society as a whole, a leading health economist found that 80 percent of all new expenditures for drugs was spent on the minor variations, not the major advances.

Institutional Corruption

These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.

Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.

Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”

Often Neither Safe Nor Effective

The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.

A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.

A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.

People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.

An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.

For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.

Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.

Why does the FDA allow paymasters to design such trials?

Failure To Warn

The FDA is charged with providing physicians and the public with objective, scientific evidence showing that new drugs are safe and effective. Conveniently for drug companies, it carries out this responsibility narrowly by focusing on the label and not on alerting physicians or the public about biased evidence from those trials in leading medical journals that go into guidelines.

The FDA could alert the profession and public about how end points and other details get switched by industry ghost-writing teams, about unpublished negative results, and about positive results published twice; but it does not. Ghost writing and the ghost management of medical knowledge thrive.

To protect the public from unsafe and ineffective drugs and earn public trust, the FDA and Congress must acknowledge the biases described here that result from pharmaceutical corporations financing the public regulator. They should also require two changes: that new drugs demonstrate patient-based clinical advantages through comparative trials, and that these trials be based on the population that will actually take a drug.

These changes would reduce the flood of minor variations shown in Exhibit 1 and the subsequent billions spent on them.

from:    https://www.healthaffairs.org/do/10.1377/hblog20150706.049097/full/

Adult Stem Cell Therapy & the FDA

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FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing Successes are Experienced Around the World

Paul Fassa, Health Impact News
Waking Times

Adult stem cell therapy is enjoying widespread success around the world, but if the FDA gets its way, it may soon be banned here in the U.S.

There have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions. It involves using the patient’s own stem cells, so no patent-able drugs are involved.

They are targeting the most influential stem cell scientist in the U.S., Dr. Kristin Comella in Florida.

Differentiating the Types of Stem Cell Therapy

Many consider stem cell therapy the future of medicine. A stem cell can rebuild or create new cells in tissues, even in organ tissues other than those from which they had originally existed.

They could be considered seeds for growing body tissues. They are mostly able to function for cellular repair and growth no matter what organ is in need of repair or healing from chronic inflammation.

There is a considerable controversy surrounding stem cell therapy research, a branch of regenerative medicine.Much of the controversy has to do with not differentiating between adult stem cell therapy and embryonic stem cell therapy.

Embryonic stem cell therapy is the controversial one. It cultures or creates stem cells from terminated or aborted fetuses.

Currently, the FDA is harassing stem cell clinics that do not derive their stem cell solutions from aborted fetus tissue. They extract the stem cells from the patient’s own adipose tissue and inject them into areas where that same patient needs repair. It’s an autologous process called adult stem cell therapy.

U.S. Stem Cell based out of South Florida is one of the clinics being targeted by the FDA, and the clinic’s Chief Scientist is Dr. Kristin Comella, PhD.

Many other nations have been using adult stem cell therapy successfully over the past 15 years, leaving the USA dead last in this field. The FDA is trying to make sure it stays that way and allows costly pharmaceutical versions to prevail.

Dr. Kristin Comella and her clinic have been under attack from the FDA.

This short 3-minute video was produced interviewing Dr. Comella and some of her patients.

Examining and Comparing the Different Types of Stem Cell Therapy

Human embryonic stem cell (hESC) therapy has received most of the media’s attention and government support. But it is the most controversial because it involves extracting tissues from terminated human embryos, aka aborted fetuses.

In addition to moral and ethical issues, human embryonic stem cell (hESC) solutions create cells so rapidly where they’re injected they lead to cancerous tumors. To avoid that, researchers have to use immuno-suppressant drugs to curb the embryonic stem cells’ tendency toward cancer.

Using pharmaceutical drugs to curb hESC cancer side effect issues leads to other unexplored and unexpected side effects from those patented stem cell solutions.

But the profit motive for embryonic stem cell therapies was strong and a lot of government funds had been put into its research. Pharmaceutical companies were motivated because they could patent stem cells created from embryonic tissues.

Bone marrow stem cell therapy was among the first to depart from flawed hESC (human embryonic stem cell) therapies developed over the past two decades. Bone marrow stem cell therapy was the segue into the adult stem cell therapy movement.

Bone marrow extractions are painful, requiring general anesthesia. It’s relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting.

Bone marrow’s high white blood cell count also encourages inflammation, making it counter-productive for patients already suffering from chronic inflammation or autoimmune disorders.

Most importantly, adipose (fat) tissue yields up to 500 times more mesenchymal stem cells than bone marrow sources, according to Dr. Comella. These are potent stem cells that can differentiate into a wide variety of other cell types. Furthermore, the adipose white blood cell count is lower than bone marrow matter.

Overactive, confused immune responses attack organs continually and create chronic inflammation and autoimmune diseases. The lower white blood cell count automatically lowers the risk of further inflammation among patients already suffering from chronic inflammation and autoimmune diseases.

The outpatient treatment involves creating a very small and shallow incision that won’t require stitches on an area of skin covering adipose tissue (fat). From there, liposuction can withdraw a portion of the fat. This part of the procedure requires only a local anesthetic.

Then what is extracted is spun at high speed in a special centrifuge to isolate the stem cells which are then purified for IV drip delivery or injection into the same patient from whom it was extracted. Total costs range from five to ten thousand dollars or more in some cases.

Dr. Comella and her colleagues’ mission is to get adult stem cell therapy available for everyone. Private and government health insurance providers cover medical treatments that are much more expensive.

Why not cover one that would save money with its lower expense and fewer side effects?

Over the years, there have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions as well as heart and lung issues.

But the three known adverse side effect cases continually get all the media attention.

The Panama College of Cell Science, which helped launch Kristin Comella’s research and development, had this to say about her:

Perhaps the most influential clinician on the subject of adult stem cell therapy, Dr. Comella has been able to quietly develop patient treatment protocols and treat patients via collaborating physicians and health care providers using legal patient-specific FDA guidelines, including studies permitted by Institutional Review Boards, patient-specific stem cell clinical trials, and direct treatments using the patients own stem cells that are harvested and re-injected for therapeutic purposes.

Through Dr. Comella’s leadership, she and her team have trained and certifiedmore than 700 physicians worldwide in adult stem cell therapy.(Source)

The interview below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy.

Big Pharma Is Using the FDA to Eliminate “Unregulated” Adult Stem Cell Competition

Since the late 1990s, adult stem cells used therapeutically were not under the control of the FDA and the adult stem cell movement took off.

There were complaints from some MDs that the adult stem cell practice should be regulated by the FDA. The Panama College of Cell Science responded to those outcries with this statement:

The motive in opposing adult stem cell therapy is money. The big institutions want to keep federal funding of embryonic stem cell research at a high level with the promise that cures are “just around the corner” despite the fact that embryonic stem cells will never be useful in any way for patient treatment because they immediately cause tumors when transplanted. (Source)

Adult stem cell therapy is an autologous treatment method. The stem cells are not lab-created. They are only isolated and purified after extracting them from the patient being treated. Injecting them back into that patient powers up the body’s own healing mechanism to overcome chronic ailments.

The FDA didn’t and shouldn’t have anything to do with regulating stem cells from one’s own body. That situation has recently been arbitrarily and suddenly changed.

Around 2014, the FDA started tweaking their guidance rules for stem cell therapy with the purpose of getting new rules made into laws through Congress that could be interpreted according to FDA whims and enforced arbitrarily. Their agenda is to consider adult stem cells as FDA-regulated drugs.

During our phone conversation, Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.

The result was that by 2017, the FDA’s hands-off policy with adult stem cell therapy came to a sudden halt after years of highly successful stem cell practice.

By 2018, the FDA got nastier with the “the most influential clinician on the subject of adult stem cell therapy” as its target. The FDA started doing inspections of Dr. Comella’s South Florida clinic that are designed for labs that manufacture drugs.

The standards for hospitals and clinics are not as strict as drug manufacturers. Those inspections were inappropriate for a clinic. But those inspections made it easier to create damaging reports.

When the inspectors came by, they demanded to go into rooms while treatments were taking place with semi-nude or nude patients, which Dr. Comella prohibited. The inspectors also demanded to view patient medical records. She allowed that after redacting their names on the copies she gave them.

For her actions to protect patients’ privacy, inspectors allegedly cited Dr. Comella for resisting and obstructing FDA inspections.

Soon after the inspections, the FDA served Dr. Comella with a lawsuit for practicing medicine with unapproved drugs. The “drugs” were only those stem cell solutions drawn from patients to be used on them.

The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and no longer promote it.

She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. The trial is set for a Federal Court hearing beginning June 2019, in Miami, Florida.

If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can afford medical tourism.

from:   https://www.wakingtimes.com/2019/03/16/fda-wants-to-shut-down-adult-stem-cell-therapy-as-its-healing-successes-are-experienced-around-the-world/

How Safe is the Impossible Burger?

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News Release: “Bleeding” veggie burger has “no basis for safety,” according to FDA

WASHINGTON, D.C. – Creators of a fake-meat burger made with a high-profile genetically engineered ingredient may have landed their experimental industry in a sizzling food safety mess, casting doubt on a Silicon Valley foodtech investor bubble.

As reported on in today’s New York Times, recently obtained documents from the U.S. Food and Drug Administration (FDA) reveal that Impossible Foods, maker of the Impossible Burger, the meatless burger that supposedly “bleeds,” was told by FDA officials that it hadn’t provided adequate proof of safety for a genetically engineered protein that gives the burger its meat-like taste and color. Impossible Foods put the genetically engineered product on the market for public consumption even though the company privately admitted to the FDA that it had not conducted or designed safety tests. The FOIA-produced documents state that the “FDA believes that the arguments presented, individually and collectively, do not establish the safety of SLH for consumption, nor do they point to a general recognition of safety.”

“The FDA told Impossible Foods that its burger was not going to meet government safety standards, and the company admitted it didn’t know all of its constituents. Yet it sold it anyway to thousands of unwitting consumers. Responsible food companies don’t treat customers this way,” said Jim Thomas of ETC Group. “Impossible Foods should pull the burgers from the market unless and until safety can be established by the FDA and apologize to those whose safety it may have risked.”

“Under no circumstances should any food company ignore FDA safety warnings and put consumers’ health at risk,” Dana Perls, senior food and technology campaigner at Friends of the Earth. “The FDA must be the authority when it comes to determining food safety, and that means overhauling the broken regulatory process so that companies like Impossible Foods cannot self-regulate and rubber stamp their products as safe.”

The FDA’s safety designation of “generally recognized as safe” (GRAS) allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe. The self-determination does not require notice to the public or the FDA, and may apply to food chemicals regardless of industry conflicts of interest, or whether the chemicals are new or not widely studied.

U.S. government documents, obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act, reveal that Impossible Foods was warned by FDA officials that its key genetically engineered ingredient, “soy leghemeglobin” (SLH), would not meet the basic FDA GRAS status. SLH, or “heme,” is a bio-engineered protein additive that adds meat-like taste and color. Impossible Foods recognizes that SLH has never been widespread in the human diet in its natural or genetically engineered form. Despite touting the color properties of the engineered “heme,” Impossible Foods did not seek FDA approval as a color additive, which has stricter safety regulations.

In discussion with FDA, Impossible Foods also admitted that up to a quarter of its “heme” ingredient was composed of 46 “unexpected” additional proteins, some of which are unidentified and none of which were assessed for safety in the dossier.

The case of Impossible Burger raises concerns that surpass this one patty and implicates the extreme genetic engineering field of synthetic biology, particularly the new high-tech investor trend of “vat-itarian” foods (meat, dairy, and other animal proteins grown in a biotech vat instead of from an animal). While Impossible Burger is the poster child for this vat-grown approach, other companies such as Perfect Day (synthetic biology cow milk) and Clara Foods (synthetic biology egg whites) appear also to be racing to market. Just as biofuels were pitched as a “clean tech” fix to climate change a decade ago, the vat-itarian venture capitalists are now attempting to capitalize on animal welfare concerns through “molecular farming.”

While the health and environmental damage caused by large-scale industrial livestock production should not be minimized, the success of non-animal burgers like the non-GMO Beyond Burger demonstrates that plant-based animal substitutes can succeed without resorting to genetic engineering.

A 2013 US National Survey by Hart Research found that 61% of respondents felt negative about synthetic biology-produced food additives. Polls also show that consumers increasingly want GMOs to be labeled as such, but so far, most companies selling products with synthetic biology ingredients, including Impossible Foods, are not labeling on the products or menus.

Friends of the Earth and ETC Group reached out last week to Impossible Foods, inviting the company to a discussion on the safety of the Impossible Burger.

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Impossible Burger FOIA documents are available here.

For further information and analysis see ETC Group’s on-line searchable database of synthetic biology derived ingredients, including Impossible Food’s “heme”.

See Friends of the Earth’s blog on synthetic biology animal replacement products “Is ‘Food-Tech’ the Future of Food?” and website for additional information on synthetic biology’s risks to our health and environment.

from:    http://www.synbiowatch.org/2017/08/bleeding-veggie-burger-has-no-basis-for-safety-according-to-fda/?lores

Walnuts – Who Knew!

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Walnuts Are Drugs, Says FDA

walnuts&drugs
by MICHAEL TENNANT

Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?

“The FDA’s language,” Faloon writes, “resembles that of an out-of-control police state where tyranny [reigns] over rationality.” He adds:

This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease. While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.

Walnuts aren’t the only food whose health benefits the FDA has tried to suppress. Producers of pomegranate juice and green tea, among others, have felt the bureaucrats’ wrath whenever they have suggested that their products are good for people.

Meanwhile, Faloon points out, foods that have little to no redeeming value are advertised endlessly, often with dubious health claims attached. For example, Frito-Lay is permitted to make all kinds of claims about its fat-laden, fried products, including that Lay’s potato chips are “heart healthy.” Faloon concludes that “the FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.”

Faloon thinks he knows why this is the case. First, by stifling competition from makers of more healthful alternatives, junk food manufacturers, who he says “heavily lobb[y]” the federal government for favorable treatment, will rake in ever greater profits. Second, by making it less likely that Americans will consume healthful foods, big pharmaceutical companies and medical device manufacturers stand to gain by selling more “expensive cardiac drugs, stents, and coronary bypass procedures” to those made ill by their diets.

But people are starting to fight back against the FDA’s tactics. “The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public,” Faloon reports. Congress is also getting into the act with a bill, the Free Speech About Science Act (H.R. 1364), that, Faloon writes, “protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.”

Of course, if the Constitution were being followed as intended, none of this would be necessary. The FDA would not exist; but if it did, as a creation of Congress it would have no power to censor any speech whatsoever. If companies are making false claims about their products, the market will quickly punish them for it, and genuine fraud can be handled through the courts. In the absence of a government agency supposedly guaranteeing the safety of their food and drugs and the truthfulness of producers’ claims, consumers would become more discerning, as indeed they already are becoming despite the FDA’s attempts to prevent the dissemination of scientific research. Besides, as Faloon observed, “If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.”

Source: The New American – Like The New American on facebook

from:    http://www.realfarmacy.com/walnuts-are-drugs-says-fda/