Archive for the ‘vaccines’ Category

The Return of HIV?

**UPDATE April, 2022**

A Chinese gene-editing scientist was recently released from prison after being sentenced in 2019 for “illegally practicing medicine” as he altered the gene CCR5, which involved in HIV’s entrance into cells, in three embryos using CRISPR-Cas9 in an attempt to give the babies protection against HIV infection.

https://thehighwire.com/videos/the-return-of-hiv/  Video Here (Approx. 17 Min)

The Return of HIV?

The Highwire

Feb. 22, 2022

A new, highly virulent variant of HIV has suddenly popped up as the media is reporting everyone should be tested. Could there be a connection to Covid?  #HIVvariant #AIDSVaccine #HIV

  • In June, 2020, Nobel Prize Winner Dr Luc Montagnier stated COVID-19 has been manipulated and that components of HIV have been inserted into the viral sequence, perhaps in pursuit of an AIDS vaccine.  He stated:
    • SARS-CoV-2 appears to be a benign bat coronavirus modified to integrate spike proteins that allows the virus to enter human cells by attaching to ACE-2 receptors
    • The virus also appears to have been modified to integrate an envelope protein from HIV called GP141, which tends to impair the immune system. A third modification appears to involve nanotechnology, which allows the virus to remain airborne longer
  • Cellular and molecular microbiologist, Dr. Judy Mikoviz also believes COVID-19 is a product of human manipulation.  She states:
    • COVID-19 — the disease — is not caused by SARS-CoV-2 alone, but rather that it’s the result of a combination of SARS-CoV-2 and XMRVs (human gammaretroviruses)
    • SARS-CoV-2 also appears to have been manipulated to include components of HIV that destroys immune function along with XMRVs
    • Interestingly, both Dr. Birx and Dr. Redfield (head of CDC) are being investigated for research fraud regarding an AIDS vaccine.
  • In October, 2020 researchers warned that some COVID “vaccines” could increase risk of HIV infection. 
  • A 2009 study’s conclusion statedAd5-specific T cells demonstrate a phenotype and proliferative potential that would support HIV infection; these results are pertinent to the findings of the Step Study and future use of Ad5 as a vaccine vector.

Regarding antibody testing, hopefully COVID testing has revealed the glaring, numerable flaws, but if this is new to you, please see:

“PCR detects a very small segment of the nucleic acid which is part of a virus itself. The specific fragment detected is determined by the somewhat arbitrary choice of DNA primers used which become the ends of the amplified fragment. ” Kary Mullis

For a brief, old interview with Mullis:  https://beforeitsnews.com/agenda-21/2020/12/kary-mullis-inventor-of-pcr-technique-about-science-fauci-and-their-agenda-engger-subtitles-  He’s obviously not a fan of Dr. Fauci.

If things were done right, “infection” would be a far cry from a positive PCR test.

“You have to have a whopping amount of any organism to cause symptoms. Huge amounts of it,” Dr. David Rasnick, bio-chemist, protease developer, and former founder of an EM lab called Viral Forensics told me. “You don’t start with testing; you start with listening to the lungs. I’m skeptical that a PRC test is ever true. It’s a great scientific research tool. It’s a horrible tool for clinical medicine. 30% of your infected cells have been killed before you show symptoms. By the time you show symptoms…the dead cells are generating the symptoms.”

I asked Dr. Rasnick what advice he has for people who want to be tested for COVID-19.

“Don’t do it, I say, when people ask me,” he replies. “No healthy person should be tested. It means nothing but it can destroy your life, make you absolutely miserable.”

Let’s review COVID testing:

Rephrased, the COVID test is a complete and utter flop which should demonstrate to all the CDC’s gross incompetence.

Lyme/MSIDS patients have struggled with the same testing issues for over 40 years with no signs of change.  Educate those around you on this pertinent fact.

CDC Withholding COVID Data & Public Health Agencies Skewing “Vaccine” Effectiveness Statistics

**UPDATE March 14, 2022**
  • Sen. Rand Paul (R-Ky.) on March 14 introduced a measure that would eliminate Dr. Anthony Fauci’s position.
  • Fauci has been director of NIAID, part of the National Institutes of Health (NIH), since 1984.
  • Paul said the measure, proposed as an amendment to the government funding bill, is necessary because Fauci has become a “dictator-in-chief.”
 
**UPDATE March 6, 2022**

Withholding data is scientific fraud

Dr. Robert Malone states that COVID injections may increase the risk of Omicron infection.  Mrna vaccinologist Geert Vanden Bossche agrees, and also points out the importance of seizing this small window of opportunity to generate herd immunity in a natural way, using the Omicron variant as a kind of ‘life-attenuated vaccine’.  He sternly warns that if they “vaccinate” against Omicron, there will be severe disease in the “vaccinated.”
 

Facts Matter (Feb. 22): CDC Caught Hiding Troves of Data: Not Publishing Critical Hospitalization, Booster, and Virus Data

By Roman Balmakov

According to a bombshell report that came out of The New York Times, it turns out that the CDC has been withholding a large amount of data from the general public.

In fact, according to this report, the CDC has been collecting detailed information on COVID-19 hospitalizations for more than a year now, and this data breaks down the cases by age, by race, as well as by vaccination status. However, instead of releasing all of this information to the public, the CDC has instead been withholding most of it.

And what’s even more damning, is that it appears that the CDC was not keeping all of this information in a vault. Instead, they were selectively pushing out only the information that supported their messaging regarding boosters.

Resources:

🔵 Sekur (promo code: Roman)  https://ept.ms/3yW0Wul

🔵 CDC article:  https://ept.ms/3JKuMaq

🔵 Scotland  https://ept.ms/3HckZYU

🔵 CDC Mask Guidance:  https://ept.ms/34TXvuN, https://ept.ms/36ApUGH

🔵 Speech Standards: https://ept.ms/3sbqJ0Z, https://ept.ms/3LQCuSd

🔵 AAP study: https://ept.ms/3IdxrsV

http://  Approx. 1 Min

CDC Withholding Data

Feb. 20, 2022

https://anti5g.net/index.php/2022/02/21/report-cdc-has-withheld-covid-data-from-americans-to-prevent-vaccine-hesitency/

Report: CDC Has Withheld COVID Data From Americans To ‘Prevent Vaccine Hesitancy’

Feb. 21, 2022

The data are “not yet ready for prime time. “

The New York Times reported this past weekend that the CDC has chosen not to publish huge amounts of COVID data, instead keeping it secret, because it fears that the information would cause ‘vaccine hesitancy’ among the American public.

The report notes that the withheld data includes informative data on boosters, hospitalizations, wastewater analyses, as well as critical information on COVID infections and deaths broken down by age, race, and “vaccination” status.

The justification for holding the information back? Fears that the data would be “ misinterpreted” and lead to “ vaccine hesitancy, ” in line with the report.

Quite simply, it didn’t fit into the narrative that everyone must get vaccinated and boosted no matter who they are and what their situation is.  (See link for article)

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SUMMARY:

  • The data has been withheld for MORE THAN A YEAR.
  • Data has been collected since COVID shots were first rolled out and the agency is afraid it will be misinterpreted. 
  • CDC director, Dr. Walensky admits guidance has been based on PCR tests which produce over 90% false positives, as well as stay positive for up to 12 weeks after infection.
  • Guidance has also been based on what they felt people would accept.
  • She also admitted that over 75% of COVID deaths in the “vaccinated” were in people who had at least 4 comorbidities.  Dr. Martenson PhD, using the CDC’s own data, shows that just 0.9% of ALL deaths had no comorbidities.

http://

CDC Hides Data to “Avoid Hesitancy”

3/2/2022

Kim Iversen

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https://www.theblaze.com/news/denominatorgate-how-public-health-agencies-are-skewing-the-statistics-on-vaccine-effectiveness

How prominent public health agencies are skewing vaccine effectiveness statistics in the US – #Denominatorgate

The Centers for Disease Control (CDC @CDCgov) and the New York City Department of Health and Mental Hygiene (NYC Health @NYCHealthy) are misleading us about the risk of being unvaccinated against SARS-CoV-2 (CoV2).

They are doing this through two basic errors. First, they appear to be using outdated population estimates that grossly undercount the actual number of unvaccinated persons in the United States. This leads to artificially inflated estimates of COVID-19 case rates among the ever-shrinking unvaccinated population.

Second, they appear to be counting every person for whom they cannot verify vaccination status as an “unvaccinated person.” In many cases, it appears that it is taking health agencies weeks, if not months, to properly match COVID-19 hospitalizations with vaccination status, and we have no assurance that it is ever done properly at all. This has led to some jurisdictions quietly publishing significant corrections to their data weeks after initial publication — and after the media and public health officials have already run with the erroneous numbers. This is leading to both overstatement of the COVID-19 case rate for unvaccinated persons and understatement of the same rate for vaccinated persons. (See link for article)

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Important excerpts:

As NYC continues to shift unvaccinated COVID outcomes to the vaccinated side, these data will show less and less apparent vaccine efficacy, but no one will know unless this issue gets addressed not only in NYC but across the U.S.

By stacking the information deck against the public, the public health community and government are gambling with our lives. We deserve and should expect an honest accounting of COVID data devoid of bias and opacity. If truth and transparency are provided, the populace would trust these public institutions, which would lead to healthier outcomes for everyone.

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**Comment**

Recently Dr. Vinay Prasad came out with a scathing video and article on “How the CDC Abandoned Science.” The information shared is important to know and understand; however, the CDC has been guilty of manipulating science and data for decades to suit their own purposes. One doctor has accused them of not even bothering to read the science. COVID has just made it more widely seen and experienced by the public. We need a complete overhaul of public health as these are captured agencies riddled with conflicts of interest. It’s so bad that a group within the agency called Spider has detailed the agency’s corruption.

For more:

Fired Pharmaceutical Workers Explain Why They Didn’t Get COVID Shots

https://www.theepochtimes.com/fired-pharmaceutical-workers-explain-why-they-didnt-get-covid-19-shots

Fired Pharmaceutical Workers Explain Why They Didn’t Get COVID-19 Shots

By Beth Brelje
February 3, 2022 
 

A major pharmaceutical company this week fired many employees who refused to get the COVID-19 vaccine. Syneos Health is a global pharmaceutical outsourcing company with some 28,000 employees in more than 110 countries. It contracts with bigger pharmaceutical companies including COVID-19 vaccine maker Johnson & Johnson/Janssen.

While J & J employs pharmaceutical representatives, it also contracts with Syneos Health to provide additional pharmaceutical representatives. Each Syneos representative is paired with one from J&J and they work together, selling drugs to doctors and other health care providers.

“It’s the same exact job, same exact customers, same exact expense reporting. Everything is the same, we’re just employed through different employers. And yet we’re being forced to be vaccinated and they’re not. We’re being told it’s because we can’t do our job, yet my Janssen counterpart can be unvaccinated, have an exemption, and still do the same exact job,” one sales representative told The Epoch Times.

(See link for article)

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**Comment**

This article perfectly exemplifies the randomness of “vaccine” mandates. They are not logical, scientific, or ethical in the least. Similar lunacy of wearing a mask all the way to the restaurant but removing it to eat (as if the virus understands this), these employees, doing the exact same work as their colleagues are forced to get the COVID jabs while their colleagues are exempt.

The employees, most with science or health backgrounds, attend a two-month pharmaceutical school when hired to learn the science behind the drugs they sell. They are foregoing the shots for the following reasons:

For more:

How the CDC Abandoned Science & ‘Science and Public Health Are Broken’

Just today, the CDC has estimated there have been over 1 million excess deaths in the U.S. since the start of the COVID ‘pandemic.’  What’s sad is many of those deaths could have been avoided if the CDC had not denied early treatments to push lucrative gene therapy injections that have been linked to more adverse reactions and deaths than any other vaccine in the history of VAERS, which many state is still woefully low. Further, the CDC is guilty of lying, flip-flopping on advice, and collusion with Big Pharma.

The mismanagement of the entire issue  of COVID needs to be acknowledged and dealt with or we will continue to revisit this. The following information is a great start:

http://  Approx. 14 Min

How the CDC Abandoned Science

Vinay Prasad MD

Article here:  https://www.tabletmag.com/sections/science/articles/how-the-cdc-abandoned-science

How the CDC Abandoned Science

Mass youth hospitalizations, COVID-induced diabetes, and other myths from the brave new world of science as political propaganda

The main federal agency guiding America’s pandemic policy is the U.S. Centers for Disease Control, which sets widely adopted policies on masking, vaccination, distancing, and other mitigation efforts to slow the spread of COVID and ensure the virus is less morbid when it leads to infection. The CDC is, in part, a scientific agency—they use facts and principles of science to guide policy—but they are also fundamentally a political agency: The director is appointed by the president of the United States, and the CDC’s guidance often balances public health and welfare with other priorities of the executive branch.

Throughout this pandemic, the CDC has been a poor steward of that balance, pushing a series of scientific results that are severely deficient. This research is plagued with classic errors and biases, and does not support the press-released conclusions that often follow.  (See link for article)

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Important quote:

The next decade will be critical as we face an increasingly existential question: Is science autonomous and sacred, or a branch of politics? I hope we choose wisely, but I fear the die is already cast.

Prasad goes through numerous studies, outlining the flaws. Definitely worth your time.

Recently a Johns Hopkins professors states to “ignore the CDC” due to their refusal to recognize natural immunity from previous infection. The WHO also recently changed the definition of herd immunity to now only come from vaccines, essentially rewriting hundreds of years of scientific understanding.

Go here for an outstanding interview with Jeremy Hammond, an independent journalist on CDC lies and censorship.  The flu vaccine is also discussed.  Scroll to 4:30 to hear Hammond.

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https://www.theepochtimes.com/exclusive-former-harvard-prof-martin-kulldorff-science-and-public-health-are-broken

EXCLUSIVE: Former Harvard Prof. Martin Kulldorff: ‘Science and Public Health Are Broken’

By Charlotte Cuthbertson
February 16, 2022 
 

Dr. Martin Kulldorff is one of the most qualified public health pandemic experts in the United States. To the narrative-shapers, he’s a pariah.

As a prominent epidemiologist and statistician, Kulldorff has worked on detecting and monitoring infectious disease outbreaks for two decades. His methods are widely used around the world and by almost every state health department in the United States, as well as by hundreds of people at the Centers for Disease Control and Prevention (CDC).

Kulldorff has also worked on vaccine safety for decades, developing globally used methods for monitoring adverse reactions in new vaccines.  (See link for article)

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Highlights:

  • Kulldorf left Harvard in November.
  • He states the public narrative was established and nobody was allowed to question it.
  • He tried to point out in March, 2020 that the focus should be to protect the elderly and high risk since the majority of people do not get severe COVID.
  • He experienced trouble publishing his paper in the U.S. due to censorship, so published in Sweden.
  • He also published the Great Barrington Declaration, with Dr. Sunetra Gupta and Dr. Jay Bhattacharya in October 2020.
  • He states the Declaration is nothing new and covers the basic fundamental principles of public health that existed in a plan that was prepared many years before but is currently being ignored.
  • He states the public is standing on firm scientific ground when they follow their intuition that the COVID restrictions aren’t based on public health science. 
  • Scientific consensus for lockdowns was formed through high-profile public health officials like Fauci, Collins, and Birx, along with mainstream media.
  • He states there aren’t any valid public health arguments against the Declaration, but that people wanting to criticize it have had to resort to slander and lies.
  • A FOIA request showed emails with Fauci and Collins communicating the need for a quick and devastating published takedown of  the Great Barrington Declaration. A day later Google began censoring search results for it.  Both men have gone on record stating the Declaration is “dangerous,” “ridiculous,” and “total nonsense.” Mainstream and social media giants then began a smear campaign against it.
  • His family members in Sweden understood his divergent tack as Sweden had a much more sane approach.
  • He stated that if you speak out against Fauci’s views, you lose funding.  If you agree with him, you get the funding.  There is currently a lot of fake science.
  • Four prominent scientists who were instrumental in shaping the COVID-19 “natural origin” narrative received substantial increases in grant money from Fauci’s NIAID in the subsequent two years.
  • Kulldorff is currently working with the Brownstone Institute as the scientific director, and is also part of Hillsdale College’s new Academy for Science and Freedom to promote and defend the importance of open, free scientific discourse.

“We shouldn’t have those conflicts. Research should be very broad, and we should fund broadly different ideas, and some pan out and some don’t, but that’s how you do good science.” Dr. Kulldorff

For more on the corrupt CDC:

FDA Exec: ‘Biden Wants to Inoculate As Many People As Possible’ & ‘Almost a Billion Dollars a Year Going into FDA’s Budget from the People We Regulate’. Califf to Head FDA: Corruption Continues…

What you are about to read will make perfect sense when you know that two high-level regulatory officials with the FDA involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation. This is not the first time issues have been raised with the FDA’s “revolving door”—a concept defined in an October 2005 paper by the Revolving Door Working Group (RDWG) as the “movement of individuals back and forth between the private sector and the public sector.”

http://  Approx. 7 Min

Feb. 15, 2022

FDA Exec on Camera Reveals Future COVID Policy “Biden Wants To Inoculate As Many People As Possible”

FDA Executive Officer, Christopher Cole:

“You’ll have to get an annual shot [COVID vaccine].  I mean, it hasn’t been formally announced yet ‘cause they don’t want to, like, rile everyone up.”

  • Cole on President Joe Biden: “Biden wants to inoculate as many people as possible.”
  • Cole on plans to approve vaccine for toddlers: “They’re not going to not approve [emergency use authorization for children five years old or less].”
  • Cole on pharmaceutical companies: “There’s a money incentive for Pfizer and the drug companies to promote additional vaccinations.”
  • Cole on the financial incentive for pharmaceutical companies: “It’ll be recurring fountain of revenue. It might not be that much initially, but it’ll be recurring — if they can — if they can get every person required at an annual vaccine, that is a recurring return of money going into their company.”
  • FDA Official Statement: “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.”
  • [WASHINGTON, D.C. – Feb. 15, 2022] Food and Drug Administration [FDA] Executive Officer, Christopher Cole, inadvertently revealed that his agency will eventually announce that annual COVID-19 vaccinations will become policy.
  • Cole is an Executive Officer heading up the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made the revelations on a hidden camera to an undercover Project Veritas reporter.
  • Cole indicates that annual COVID-19 shots isn’t probable — but certain. When pushed on how he knows an annual shot will become policy, Cole states, “Just from everything I’ve heard, they [FDA] are not going to not approve it.”
  • The footage, which is part one of a two-part series on the FDA, also contains soundbites from Cole about the financial incentives pharmaceutical companies like Pfizer have to get the vaccine approved for annual usage. “It’ll be recurring fountain of revenue,” Cole said in the hidden camera footage. “It might not be that much initially, but it’ll recurring — if they can — if they can get every person required at an annual vaccine, that is a recurring return of money going into their company.”
  • Perhaps the most explosive part of the footage is the moment where Cole brazenly talks about the impact that an Emergency Use Authorization has on overcoming the regulatory concerns of mandating vaccines on children. 

“They’re all approved under an emergency just because it’s not as impactful as some of the other approvals,” Cole said when asked if he thought there was “really an emergency for kids.”

Cole, who claims his role with the FDA is to ensure the agency uses a framework of safety, security, and effectiveness as a part of its preparedness and response protocol, specifically cited concerns over “long term effects, especially with someone younger.”

http://  Approx. 8 Min

FDA Executive Officer Exposes Close Ties Between Agency and Pharmaceutical Companies:

‘Almost a Billion Dollars a Year Going into FDA’s Budget from the People we Regulate’

• FDA Executive Officer Chris Cole: “The drug companies, the food companies, the vaccine companies. So, they pay us hundreds of millions of dollars a year to hire and keep the reviewers to approve their products.”
• Cole on FDA fees: “Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers which will speed up the approval process. So, they [pharmaceutical companies] make more money.”
• Cole: “They [FDA] tone down the impact of the user fees on their operations because they know they’re dependent on the drug companies, and the vaccine companies, and these other companies for their agency to operate.”
• Cole on blowing the whistle: “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it.”
• Cole on retaliation in government: “You’ll be marked from getting other jobs because another office is not going to want to hire you if you’ve spoken out about something, right or wrong. They don’t look at what you’ve spoken out about. They’re just not willing to- government’s about rocking the boat and they don’t want to- which is the problem I have with- one of the problems I have with government is, like, they don’t like people rocking the boat, for right or wrong, at all costs. They want to hire a safe person that can do the job but doesn’t necessarily- is a great hire.”

[WASHINGTON, D.C. – Feb. 16, 2022] Project Veritas published Part Two of its series on the FDA on Wednesday night which featured FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses.

In the footage, Cole talks about the impact that pharmaceutical companies have on the agency including the process for approving drugs.

“A long time ago, Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers, which will speed up the approval process, so they make more money,” Cole says in the hidden camera footage.

He then reveals that the FDA tones down the impact that these user fees have on the agency’s operations because, “they’re dependent on the drug companies, and the vaccine companies and these other companies for their agency to operate.”

The incendiary footage, which features Cole talking about how the additional money the FDA brings in “gets banked” to be spent on “whatever you can, whether it’s right or wrong,’’ also features Cole discussing reasons why it’s difficult for anyone in government to speak out about practices he sees as “probably excessive.”

“I don’t think there’s enough people saying — they’re, like, ‘Look, that’s fine, but that’s not right. So, we’re not going to charge that.’ You don’t want to be that person. You’re not going to have a long shelf life in the agency if you’re always that person,” Cole said.

“There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it. The whistleblower, well, it’s high-profile whistleblower statutes and everything, that’s kind of ridiculous,” Cole said before adding “it’s better to just stay quiet and accept.”

Cole’s LinkedIn page lists him as an Executive Officer within the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made these revelations on a hidden camera to an undercover Project Veritas reporter.

A spokesperson for FDA issued a statement yesterday saying, “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.”

This statement appears to contradict a phone call released Wednesday afternoon by Project Veritas wherein Cole reiterated, during the conversation with Project Veritas Founder and CEO, James O’Keefe, that he is “a manager in the office that helps oversee the approval of the COVID vaccines for emergency approval.”

Please see below in the link that indeed, Dr. Robert Califf was voted in to head the FDA.  We can only expect the corruption to continue under his reign.

For more:

Apparently Robert Califf did such a good job of helping Big Pharma shield themselves from any liabilities due to the opioid crisis that destroyed the lives of so many Americans while he was head of the FDA under President Obama, that he is being brought back to lead the FDA again to help Big Pharma continue growing in record profits and sales as they get ready to expand the market for the COVID-19 gene-altering shots by having Americans get vaccinated every year, along with the already profitable flu shots.

While he was approved to lead the FDA by the Senate in an overwhelming vote of support with an 89-4 Senate vote on his confirmation in 2016, this time around he barely survived the confirmation vote which was 50-46, facing bi-partisan opposition to his confirmation.

Senators Joe Manchin and Republican Senator Mike Braun from Indiana paired up to write an op-ed piece published at USA Today to voice their opposition to Califf’s confirmation as head of the FDA.

Since OxyContin was approved by the Food and Drug Administration in 1995, more than 500,000 Americans have died from overdoses related to opioids and synthetic opioids.

Nearly three decades later, more than 101,000 Americans – over 1,500 West Virginians and nearly 2,500 Hoosiers – died between June 2020 and June 2021. It’s clear that not much has changed in the way the FDA approves and manages these highly addictive, destructive drugs killing Americans at an astonishing rate.

In fact, it has become increasingly clear that the FDA has stood by, and even enabled, the pharmaceutical industry’s decision to choose profits over American lives.

High overdose rates, not enough treatment facilities

Many families across the United States have been impacted by the drug epidemic that continues to ravage our nation. In our beloved states of West Virginia and Indiana, our communities continue to face disproportionately high overdose rates, with not nearly enough treatment facilities to care for our neighbors in need.

However, instead of reining in opioid prescribing, the agency in charge of regulating these substances continues to approve even more deadly opioids. It is crystal clear that the FDA has not done enough to address the drug epidemic ravaging our nation.

Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address this crisis in any meaningful way.

A poor record on opioids

The current FDA commissioner nominee, Dr. Robert Califf, has significant ties to the pharmaceutical industry, and his leadership of the FDA would take us backward, not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.

During Dr. Califf’s previous tenure as FDA commissioner, drug-related overdoses went up, a clear indicator the FDA hadn’t made any necessary, meaningful changes to address the crisis facing our country. In 2016, then-Commissioner Califf announced the FDA’s plan to overhaul its opioid policies.

But between 2016 and 2017, the FDA approved five new opioids and only removed a single opioid from the market. Dr. Califf also commissioned a report on opioids, but the report failed to review the flawed enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids.

Reports have also indicated that Dr. Califf intends to keep Dr. Janet Woodcock on board as a senior adviser if confirmed to lead the FDA. During her tenure at the FDA, Dr. Woodcock has directly overseen the approval of numerous highly addictive drugs to market.

She also decided to ignore the advice of an FDA advisory committee when she chose to approve Zohydro, a questionable pure hydrocodone drug with strong risk of overdose and death.

The pharmaceutical industry has benefitted from the status quo at the FDA under the leadership of Dr. Califf and Dr. Woodcock, and the American people have suffered for it. (Full article.)