Author Archive

70% of TN Embalmers Still Seeing White Fibrous Clots in 1 Out of Every 6 Corpses

https://gregreese.substack.com/p/70-of-tennessee-embalmers-still-seeing?

70% of Tennessee Embalmers Still Seeing Death by Clot Shot

And 39% are seeing a fourteen percent increase in Infant Death

Greg Reese
Jun 24, 2025

Just around three years ago, as millions of people around the world were dying from strokes and heart attacks shortly after getting the experimental gene editing COVID shots, coroners and embalmers began finding large dense clots in the vascular system of the dead. Clearly large enough to explain the cause of death, but ignored by government and media. And the public, including children, are still getting these clot shots.

During the winter of 2023/2024, Thomas Haviland conducted the, “Worldwide Embalmer Blood Clot Survey,” where in embalmers from the United States, Canada, Australia and the UK were surveyed about the blood clots. The study found that the “White Fibrous Clots” were not seen by anyone Pre-Covid/jab, and over seventy percent were seeing them after the Covid/jab in twenty percent of their corpses. And about twenty percent of embalmers saw a twenty-five percent increase in Infant Death after the Covid/jab. (See link for article and video)

_______________

**Comment**

Yet crickets from ‘public health,’ mainstream media, and mainstream medicine.

For more:

Category:

Activism, Heart Issues, research, vaccines

MAHA Betrayal. RFK’s Public Plan? Get Every American to Buy a Wearable Device

https://rumble.com/v6vd5af-maha-betrayal-bureaucracy-and-vaccine-silence  Video Here (Approx. 12 Min)

MAHA: Betrayal, Bureaucracy & Vaccine Silence

Dr. Peter McCullough on The Shannon Joy Show.

Bobby Kennedy Jr. fired ACIP’s old guard and replaced eight of the 17 members with researchers and physicians.

According to Senator Bill Cassidy (R-La) many of the new members do not have significant experience studying microbiology, epidemiology or immunology.

The other six new members tapped by Kennedy are:

  • Dr. Joseph R. Hibbeln, a psychiatrist and neuroscientist with a career in clinical research, public health policy and federal service.
  • Retsef Levi, Ph.D., a professor of operations management at the MIT Sloan School of Management and a leading expert in healthcare analytics, risk management and vaccine safety.
  • Dr. Robert Malone, a physician-scientist and biochemist known for his early contributions to mRNA vaccine technology.
  • Dr. Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth and a nationally recognized expert in pediatric infectious diseases and vaccine policy.
  • Dr. James Pagano, a board-certified emergency medicine physician with over 40 years of clinical experience following his residency at UCLA.
  • Vicky Pebsworth, Ph.D., a registered nurse who holds a doctorate in public health and nursing from the University of Michigan.

Although most in mainstream medicine, including the beholden American Academy of Pediatrics, is going ballistic over the change, no vaccine mandates have been repealed, no liability from vaccine manufacturers has been lifted, and there is still no justice for the vaccine-injured.

Just more committees, more pharma-friendly advisors, and more gaslighting.

On a positive note: the new committee announced plans to look at the cumulative effect of all ‘vaccines’ given during childhood.

(See link for 12 Min video)

For more:

UPDATE: Scroll to 10:00 to listen to Michael Kane (TeachersforChoice.com) interview Aimee (FirstHandMedia.substack.com) on “Wearables: Incentives for the Health Data Trap.”

Her Substack article is here.  Key quotes:

The problem is, the civil liberties and privacy risks this new infrastructure poses are equally significant. A system that is able to constantly collect health data on individuals through biometric devices and make our health records accessible everywhere to anyone who has the authority to access them raises crucial questions about how that authority is granted and how the information is owned and controlled.

As it stands, both federal and state laws give public health officials the authority to access individuals’ health information without their knowledge or consent for public health purposes. A patchwork of state consumer health data privacy laws is gradually coming together to give individuals more control over how businesses can use their data, but it’s far from complete or cohesive.

And that’s not all. With the integration of social determinants of health data into health records, a vast catalog of detailed information about all aspects of an individual’s life can be encoded, stored, and made accessible to authorized users via the internet of health information.

Remember, what starts out as choice can be turned into mandate or force.

https://childrenshealthdefense.org/defender/maha-report-falls-short-wireless-radiation-chronic-disease-emr/

MAHA Report ‘Falls Short’ on Linking Wireless Radiation to Chronic Disease, Experts Say

“The MAHA Report” only briefly mentioned electromagnetic radiation and failed to accurately convey the scientific literature showing harm. “Nonetheless, it has broken ground as the first formal acknowledgement by the executive branch that there is a problem,” said Odette Wilkens, a technology attorney.

by Suzanne Burdick, Ph.D.
June 3, 2025
maha report cover and 5g cell tower

The Make America Healthy Again (MAHA) report briefly mentioned  electromagnetic radiation (EMR), but failed to accurately convey the scientific literature revealing how it harms human health, according to EMR experts and safe technology advocates who spoke with The Defender.

“The MAHA Report,” released May 22, identified four “key drivers” behind the childhood chronic disease epidemic. EMR, which wasn’t included as a main driver, was mentioned only briefly in the report’s section on environmental chemicals.

Miriam Eckenfels, director of Children’s Health Defense’s (CHD)  Electromagnetic Radiation (EMR) & Wireless Program, said EMR should have been listed as a fifth main driver.

“The report’s discussion of EMR serves as a conversation-starter,” Eckenfels said. “But it misses the mark in terms of acknowledging the impact of wireless radiation on the childhood chronic disease epidemic.” (See link for article)

https://www.pcmag.com/news/rfk-jrs-public-health-plan-get-every-american-to-buy-a-wearable-device

RFK Jr.’s Public Health Plan? Get Every American to Buy a Wearable Device

Wearables can save lives, and the HHS secretary plans to kick off a major advertising campaign to encourage Americans to use them. Will this lead to the government collecting your health data?

By Emily Forlini
June 24, 2025
Health and Human Services Secretary Robert F. Kennedy Jr. wants everyone to wear a smartwatch, fitness tracker, or other piece of wearable health tech as part of his “Make America Healthy Again” (MAHA) agenda.

“My vision is every American is wearing a wearable within four years,” he told a House subcommittee today. “It’s a way of people taking control over their own health. They can take responsibility. They can see…what food is doing to their glucose levels, their heart rates, and a number of other metrics as they eat it.”

(See link for article)

_______________

**Comment**

This website has been posting on the dangers of digitization for years and it’s far, far bigger than health.  It encompasses everything on planet earth – but health and convenience are simply being used as tools to push it further down the road.  After all, who doesn’t want better health?

The problem is there are many issues wearable health tech presents: privacy, ethics, safety, and control.

In 2022, we were warned about a new biomedical research agency modeled after DARPA that will merge national security and health ‘security,’ with the potential to criminalize both mental and physical illness as well as ‘wrongthink.’

All of this merging, monopolizing, and digitizing makes it very easy for a government to wield extraordinary power and control against its citizens through a digital dictatorship.

This diabolical trend is bipartisan and began in 2019 for the purpose of stopping mass shootings before they happen through monitoring of the public for ‘neuropsychiatric’ warning signs.

Lyme/MSIDS patients should pause and reread that sentence. Those of us suffering with a life-altering a systemic infection that affects the brain and that can cause all sorts of psychiatric manifestations should be on high alert as if this had happened while we were struggling mentally, we’d probably all be sitting in jail.

Category:

Activism

Complaint Against Dr. Paul Gisbert Auwaerter License Number: D0041413

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/33656237?

Complaint against Dr. Paul Gisbert Auwaerter License Number: D0041413

Carl Tuttle
Hudson, NH, United States
Jun 27, 2025

Please see the following complaint submitted to the Maryland Board of Physicians along with their response. I followed up in disgust as the disinformation continues year after year decade after decade by the same deceitful individuals who have been propagating the false Lyme disease narrative.

If you agree with my complaint, please voice your concerns by writing to Wes Moore, Governor of Maryland where Dr Paul Auwaerter practices medicine. Reference this Petition Update link and lets flood his inbox with emails! (No matter where you live!!)

governor.mail@maryland.gov

lt.governor@maryland.gov

Picture of Governor Moore found here: https://www.mbp.state.md.us/

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “mdh.mbp_intake@maryland.gov” <mdh.mbp_intake@maryland.gov>
Cc: “oag@oag.state.md.us” <oag@oag.state.md.us>, “cquattrocki@oag.state.md.us” <cquattrocki@oag.state.md.us>, “musa.eubanks@oag.state.md.us” <musa.eubanks@oag.state.md.us>
Date: 06/21/2025 7:56 AM EDT
Subject: Complaint against Dr. Paul Gisbert Auwaerter License Number: D0041413

June 21, 2025

Maryland Board of Physicians
Complaint Intake Unit
4201 Patterson Avenue
Baltimore, MD 21215

Re: Dr. Paul Gisbert Auwaerter, License Number: D0041413

To whom it may concern,

I would like to file a complaint against Dr. Paul Gisbert Auwaerter for propagating false/misleading statements regarding the testing and treatment of tick-borne diseases as there exists a substantial risk of serious harm to public health, safety, and welfare from his misinformation.

Please see the following correspondence with Dr Auwaerter and Medscape’s Editorial Staff regarding the misinformation Auwaerter has been allowed to spread (and viewed by physicians across the country) essentially downplaying the threat of tick-borne disease co-infections while claiming serology for Lyme disease is a “good test.” This deliberate misrepresentation is an ethical concern as Auwaerter, past president of the Infectious Diseases Society of America, is considered an “expert” in the field.

This is not an isolated case. The IDSA has had a history of misinformation; In 2021, the Patient Centered Care Advocacy Group demanded the removal of an inaccurate statement by the IDSA which excluded maternal-fetal transmission of Lyme disease. Congenital transmission was fist described in 1985.

Advocate asks IDSA to remove false statement about Lyme transmission
https://www.lymedisease.org/fries-idsa-remove-false-statements/

Auwaerter was the lead author of the deplorable Lancet Infectious Disease article:

Antiscience and ethical concerns associated with advocacy of Lyme disease
https://pubmed.ncbi.nlm.nih.gov/21867956/

Please consider sending a cease-and-desist letter to Dr. Auwaerter demanding an end to his engaging in this harmful misinformation campaign and require a correction and/or retraction of the statements identified in the correspondence that follows.

A response to this complaint is requested.

Respectfully submitted,

Carl Tuttle
Independent Researcher
Hudson, NH

Cc: Anthony G. Brown, Attorney General
Carolyn A. Quattrocki, Chief Deputy Attorney General
Musa L. Eubanks, Principal Counsel Maryland Department of Health

Correspondence with Dr Auwaerter and Medscape’s Editorial Staff:

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “pauwaert@jhmi.edu” <pauwaert@jhmi.edu>, “pgauwaerter@gmail.com” <pgauwaerter@gmail.com>
Cc: “aaguilar@webmd.net” <aaguilar@webmd.net>, “DFlapan@Medscape.net” <DFlapan@Medscape.net>, “lkane@medscape.net” <lkane@medscape.net>, “gamiller@medscape.net” <gamiller@medscape.net>, “dolmos@webmd.net” <dolmos@webmd.net>, “sarah.wright@webmd.net” <sarah.wright@webmd.net>, “editor2@webmd.net” <editor2@webmd.net>, “mmcnutt@nas.edu” <mmcnutt@nas.edu>, “jliao@nas.edu” <jliao@nas.edu>, “news@medscape.net” <news@medscape.net>
Date: 06/15/2025 12:13 PM EDT
Subject: Medscape: Chronic Lyme Infection-Associated Illness in Urgent Need of Symptom-Targeted Treatments

June 15, 2025

The IDSA Foundation
1300 Wilson Boulevard Suite 300
Arlington, VA 22209
Attn:  Paul Auwaerter, vice chair of the IDSA Foundation

Dr Auwaerter,

I would like to call attention to the following Medscape article referencing the recent National Academies of Sciences review of Lyme disease through a recommendation of the Tick Borne Disease Working Group calling for a review of all the literature.

Medscape Medical News June 10, 2025

Chronic Lyme Infection-Associated Illness in Urgent Need of Symptom-Targeted Treatments
https://www.medscape.com/viewarticle/chronic-lyme-infection-associated-illness-urgent-need-2025a1000fhv

Regarding laboratory testing…

“The current two-tier serologic testing approach based on the Dearborn criteria has limitations and may not detect all cases of Lyme disease, particularly in patients with early or late disease or those who remain symptomatic after treatment.”

In contrast Dr. Auwaerter you continue to promote serology as a “Good Test” with your recent recorded interview for the so-called “Clinician Toolkit” promoted by the American Medical Association which just so happened to be paid five million dollars to buy into this misinformation through CDC grant#  NU50CK000597

Oct 3, 2024
Improving Care for Patients with Prolonged Symptoms and Concerns about Lyme Disease: A Clinician Toolkit 
https://www.ama-assn.org/delivering-care/public-health/improving-care-patients-prolonged-symptoms-and-concerns-about-lyme

Imbedded recording:

Understanding Lyme Disease with Dr. Paul Auwaerter (@12:30 into the recording)

“If you have symptoms for more than a few weeks it’s a very good test and I think there’s a common misconception it’s not a good test. And what is true is it’s not a good test if you’ve only been infected for a week or two because the body hasn’t mounted enough time to develop antibodies. But if people have had symptoms for three, four weeks or longer, it is a good blood test to help assess these later symptoms that could be neurologic, muscular, skeletal, or occasionally cardiac.” – Paul Auwaerter

Serology is so unreliable that in 2013 Virginia Governor Bob McDonnell signed HB1933 into law requiring healthcare providers to notify those tested that current laboratory testing can produce false negatives.

Governor Chris Sununu’s 2020-2021 commission to study diagnostic testing for Lyme disease concluded that the FDA approved two-tier serologic immunoassay for Lyme was not reliable in all stages of disease; no better than a coin toss.

Peer-reviewed evidence of “Seronegativity in Lyme borreliosis and Other Spirochetal Infections” 16 September 2003
https://www.dropbox.com/s/3d6m45jzlhhwalu/Seronegativity.pdf?dl=0

And yet Dr. Auwaerter you continue to promote serology as a “good test”

Furthermore, you refused to answer my inquiry regarding your Medscape commentary of Oct 2023

Medscape COMMENTARY

New Federal Oversight of Lab Developed Tests
https://www.medscape.com/viewarticle/997365

Excerpt:

“I often see patients who are concerned they might have Lyme disease, or they’ve been told by other physicians that they have a tickborne or multiple infections. I’ve had patients who claim to have five or six infections: Lyme disease, Babesia, Bartonella, Mycoplasma, or Epstein-Barr virus. They bring LDT results from outside laboratories, which often have a proviso that these tests are only for research or educational purposes. Yet, they purport finding analytes (antibodies or proteins) that suggest the patient has an active infection. These patients may have been treated but are not improving, so they are referred to me.” – Paul Auwaerter

Carl Tuttle’s Inquiry: (which remains unanswered and posted to that commentary)

Dr. Auwaerter… I would like to call attention to the following 2009 tick study conducted here in New Hampshire:
 
Correlation between Tick Density and Pathogen Endemicity, New Hampshire
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671416/
 
The study found deer ticks were carrying multiple pathogens (co-infections) that could be transmitted in a single bite.
 
What FDA approved Tick-Borne Disease Panel are you recommending so as not to miss any of these infections?
 
A response to this inquiry is requested.
 
Carl Tuttle
Hudson, NH
___________________

Dr. Auwaerter,

Are you aware of the following announcement? IGeneX is finding those “multiple infections” you claim do not exist….

IGeneX Lyme ImmunoBlot test kit receives FDA clearance
https://www.lymedisease.org/lyme-immunoblot-fda-clearance/

GETTING STARTED WITH IGENEX
https://igenex.com/wp-content/uploads/getting-started-with-igenex.pdf

A 2018 study of 10,000+ patient samples from nearly every state:
 
37.3% were positive for Babesia species
32.1% for Lyme Borrelia
27.7% for TBRF Borrelia
19.1% for Bartonella
16.7% for Anaplasma
12.8% for Rickettsia
6.9% for Ehrlichia

Co-infections:

40% tested positive for two pathogens
15% tested positive for three pathogens
4.6% tested positive for four pathogens
0.7% tested positive for five pathogens

What is going on here Dr. Auwaerter? Are you completely uninformed or deliberately promoting misinformation? Will you be correcting/retracting your statements?

A response to this inquiry is requested.

Carl Tuttle
Independent Researcher
Hudson, NH

Cc: MEDSCAPE EDITORIAL STAFF
Marcia McNutt, President of the National Academy of Sciences and Chair of the National Research Council
Send comments and news tips to news@medscape.net

_________________________________________________________________

To the Maryland Board of Physicians:

Additional complaints against Auwaerter:
 
1. The Mayday Project Responds to Dr. Paul Auwaerter’s Defense of IDSA Guidelines for Lyme Disease
https://www.webwire.com/ViewPressRel.asp?aId=192558

2. Hopkins Physician Says Lyme Disease Patients Create Conspiracy Theories About Their Illnesses
https://www.webwire.com/ViewPressRel.asp?aId=197392

3. Mothers Against Lyme Calls for Retraction of False Information on Congenital Lyme in IDSA, AAN, ACR Guidelines
Retraction request cites harm to pregnant women and children
https://www.webwire.com/ViewPressRel.asp?aId=281005

4. Detailed patient experience because of the false information (Please read)
https://www.facebook.com/photo/?fbid=30451510191160844

Excerpt:

“I’ve tried explaining this a few times and I won’t stop until people get it. This isn’t like cancer or any other disease where I can go to a Dr that’s covered by my insurance and receive treatment. What is happening here is criminal and if you don’t believe me, ask ANYONE with Lyme.”

Response from the Maryland State Board of Physicians

———- Original Message ———-
From: MDH mbp_intake -MDH- <mdh.mbp_intake@maryland.gov>
To: CARL TUTTLE <runagain@comcast.net>
Date: 06/26/2025 11:09 AM EDT
Subject: Re: Complaint against Dr. Paul Gisbert Auwaerter License Number: D0041413

Good morning, Mr. Tuttle:

Please see the attached.

Thank you,
Intake Unit
Maryland State Board of Physicians

The Board of Physicians is committed to customer service.  Please visit https://www.doit.state.md.us/selectsurvey/TakeSurvey.aspx?agencycode=MBP&SurveyID=86M2956 to take our Customer Satisfaction Survey.

My reply to the Maryland State Board of Physicians:

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: MDH mbp_intake -MDH- <mdh.mbp_intake@maryland.gov>, “jennifer.saylor-florio@maryland.gov” <jennifer.saylor-florio@maryland.gov>
Cc: “Harbhajan.Ajrawat@maryland.gov” <Harbhajan.Ajrawat@maryland.gov>, “Christine.Farrelly@maryland.gov” <Christine.Farrelly@maryland.gov>, “hajrawat@gmail.com” <hajrawat@gmail.com>, “oag@oag.state.md.us” <oag@oag.state.md.us>, “cquattrocki@oag.state.md.us” <cquattrocki@oag.state.md.us>, “governor.mail@maryland.gov” <governor.mail@maryland.gov>, “lt.governor@maryland.gov” <lt.governor@maryland.gov>
Date: 06/27/2025 8:31 AM EDT
Subject: Re: Complaint against Dr. Paul Gisbert Auwaerter License Number: D0041413

Intake Unit
Maryland State Board of Physicians,
via   <jennifer.saylor-florio@maryland.gov>

Dr. Saylor-Florio,

I would like to call attention to the following statement found in the attached response to my complaint against Dr Paul Auwaerter:

“The Board of Physicians is responsible for assuring that licensed physicians and allied health practitioners render competent medical care to the citizens of Maryland”

Isn’t that statement a bit hypocritical when you allow a physician to claim serology for Lyme disease is a “good test” when in fact it is no better than a coin toss while using his position of authority as past president of the IDSA to propagate that falsehood?

I question the credibility of this medical board willing to turn a blind eye to Auwaerter’s misleading statements. How could he possibly provide competent medical care believing that serology is a good test while tick-borne co-infections are of little concern? The potential for harm or negative outcomes is substantial and noteworthy.

Carl Tuttle
Independent researcher
Hudson, NH

Cc: Harbhajan Ajrawat, M.D. Chair
Anthony G. Brown, Attorney General
Carolyn A. Quattrocki, Chief Deputy Attorney General
Wes Moore, Governor
Aruna Miller Lt Governor

_______________

**Comment**

I find it quite telling that the Maryland Board of Physicians claims it does not have legal authority to investigate Dr. Auwaerter’s patently false statements about Lyme testing.  State Boards over Physicians had no trouble whatsoever investigating and persecuting any doctor during COVID who advocated for treatments (ivermectin, HCQ, vitamins, etc.) other than what the top-down accepted narrative had to offer (ventilators, remdesivir, the clot shot, etc), or whom questioned the clot shot gene therapy which was touted as ‘safe and effective,” like a mantra.

Do not expect justice from these ‘professional’ medical groups.

They are on the wrong side of the fence.

For More:

Category:

Activism, Lyme, Testing

Breaking: TN Funeral Directors Association Confirms White Fibrous Clots Are Real & Prevalent

**UPDATE**

Go here to see Greg Reese‘s work on the clots in a video that’s under 5 minutes long.

https://www.thefocalpoints.com/p/breaking-tennessee-funeral-directors?  Video Here (Approx. 30 Min)

BREAKING: Tennessee Funeral Directors Association Confirms White Fibrous Clots Are Real and Prevalent

Former USAF Major Tom Haviland Joins to Discuss the First State-Level Acknowledgment of White Fibrous Clots

Jun 16, 2025

By Nicolas Hulscher, MPH

Former USAF Major Tom Haviland joins me to discuss his presentation at the 2025 Tennessee Funeral Directors Association (TFDA) Convention—marking the first time a U.S. state funeral directors association has publicly acknowledged that white fibrous clots are real, prevalent, and ongoing.

Invited by TFDA President Taylor Moore, Haviland conducted an in-person survey with 28 embalmers and funeral directors during the convention in Franklin, TN:

  • 64% reported seeing white fibrous clots in corpses during the first half of 2025
  • The white clots appeared in an average of 17% of all corpses
  • 70% reported signs of micro-clotting (“coffee grounds” or “dirty blood”)
  • 39% of embalmers observed an increase in infant deaths, with an average 14% rise over pre-2020 levels

This public acknowledgment demands immediate investigation into the potential link between the COVID-19 mRNA injections, SARS-CoV-2 infection, and the formation of these anomalous clots. It’s time our public health agencies respond.

You can find all of Tom Haviland and Laura Kasner’s work from the past three years on their Substack: Clotastrophe

According to Dr. Kevin McCairn et al’s intensive biochemical and microscopic analysis, the white fibrous clots appear to be amyloidogenic fibrin aggregates—abnormal, protease-resistant protein structures likely formed through pathological remodeling of fibrin in the presence of spike protein. The clots exhibit dense, rubbery morphology, strong autofluorescence, beta-sheet-rich domains confirmed by Thioflavin T staining, and ultrastructural features consistent with amyloid fibrils under electron microscopy. Elemental analysis confirmed their organic, protein-based composition, and PCR detected human origin with preliminary markers suggestive of recombinant spike protein exposure.  (See link for video, article, and pictures)

_______________

**Comment**

Nobody’s talking about it, but Dr. Ben Marble recently posted that we need to quit accepting blood from people who took the COVID gene therapy shots because the spike protein is a serious toxin – not to mention all the other contaminants in the shots.

Proving this, a baby died of a large blood clot after a doctor ignored parents’ request for unvaccinated transfusion and a man developed Bells Palsy and other vaxxed symptoms after a blood transfusion, yet the American Red Cross put out a statement in 2023 that all of this is just misinformation.

It all continues to be safe and effective.

It’s your life.  You decide.

For more:

I could go onto infinity with this…..

Category:

Activism, Heart Issues, vaccines

FDA Approved Hundreds of Drugs With No Evidence They Work

https://childrenshealthdefense.org/defender/fda-approved-hundreds-drugs-no-evidence-they-work/?

FDA Approved Hundreds of Drugs With No Evidence They Work

A two-year investigation by The Lever found the FDA approved hundreds of drugs over the last several decades with little to no evidence that they work. The investigation found that many of the approved drugs that provided no benefit were allowed to stay on the market, despite evidence that they cause serious harm.

by Brenda Baletti, Ph.D.
June 5, 2025
pills and fda approved logoThis article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

The U.S. Food and Drug Administration (FDA) has approved hundreds of drugs over the last several decades with little to no evidence that they work, according to a new investigation by The Lever.

Many of the drugs are permitted to stay on the market, despite ample evidence that they don’t work and that they cause serious and irreparable harm.

The Lever’s two-year investigation into the FDA-approved drugs analyzed government reports, internal FDA documents, investigators’ notes, congressional testimony, court records and more than 100 interviews with researchers, federal officials and patients.

The investigation found that from 2013 through 2022, 73% of drugs approved by the FDA didn’t meet the agency’s four foundational standards required to show the drugs work as expected. Fifty-five of the approved drugs met only one of those four standards, and 39 met none of them.

More than half of drug approvals were based on preliminary data, which meant the pharmaceutical companies didn’t submit evidence that patients had fewer symptoms, showed improvement or had their lives extended.

The approval rate of such drugs has accelerated over the last decade, according to the U.S. Department of Health and Human Services Office of Inspector General.

Cancer treatments, in particular, raised serious red flags. Only 2.4% of the 123 cancer drugs met all of the criteria, and 29 met none. The FDA approved 81% of cancer drugs based on preliminary data.

The report did not evaluate any vaccines.

The Lever wrote:

“These statistics come after billions of dollars and years of lobbying by the pharmaceutical industry and patient advocacy groups pressuring Congress to loosen the FDA’s scientific standards.

“The resulting seismic shift from proving drugs work before they are approved to showing they work only after approval — if ever — has been quietly accomplished with virtually no awareness by doctors or the public.

“Insurers and taxpayers effectively pay for research after drugs hit the market as pharmaceutical companies reap the profits. Patients serve as the unwitting guinea pigs — with very real consequences.”

The outlet also reported that an estimated 128,000 people are killed each year by side effects from prescription drugs prescribed as indicated.

Demand for drugs during the AIDS epidemic led to lowered standards

The FDA regulates $3.9 trillion worth of products each year, including drugs, food, supplements, tobacco and medical devices, according to The Lever.

Until the AIDS epidemic in the 1980s, the agency had stricter regulatory procedures. However, demands by activists seeking faster access to new drugs in the context of the AIDS crisis, with the support of the pharmaceutical industry, resulted in the loosening of requirements for some drugs.

For example, requirements that pharmaceutical companies submit more than one randomized controlled clinical trial showing that a drug is effective meant that researching drugs took time — the entire approval process could take up to 12 years.

In 1992, the FDA created the “accelerated pathway,” allowing companies to submit only preliminary data showing AIDS drug effectiveness. Companies were expected to submit further evidence of effectiveness after the drugs were on the market.

The new rules also allowed companies to win approval without showing clinical outcomes — evidence that a drug positively affected a patient’s life. Instead, they could test for “surrogate outcomes,” considered “reasonably likely to predict” a clinical benefit.

For example, instead of a medication for strokes showing that it stops strokes, it can show a surrogate endpoint, such as controlling blood pressure. The AIDS drug AZT won approval on that basis — it increased the number of T-cells needed to fight viruses, but had no effect on AIDS and instead proved extremely toxic to those who took it.

GSK, the original manufacturer of AZT, reaped $2 billion in profits.

In 1992, Congress formalized the reduced standards in the Prescription Drug User Fee Act, which explicitly directed the FDA to allow approvals based on lower standards.

Pharmaceutical contributions to political campaigns shot up before the bill passed, from $1.9 million in 1990 to $3.6 million in 1992.

FDA approves drugs based on ‘flimsy, contradictory, and inadequate’ evidence

The Lever identified four key criteria drugmakers should meet, according to FDA standards, to assess whether drugs are safe and effective. They are:

  • Control group: Patients taking the drug were compared to a control group that was given a placebo or a comparator drug.
  • Replication: At least two “well-controlled” trials showed the drug was effective.
  • Blinding: Subjects in the studies and the doctors who cared for them don’t know which patients are on the drug and which are in the control group.
  • Clinical endpoint: The studies measured the drug’s effect on patients’ survival or function rather than a surrogate measure.

The authors note that these criteria don’t guarantee “sound scientific evidence,” but make up the minimum criteria to determine whether the drugmakers have provided “substantial evidence” to support their claims.

Only 28% of drugs approved over the 10 years studied met the four criteria. Twenty-nine percent met three criteria and more than 9% didn’t meet any of them.

“That doesn’t mean these drugs don’t work, but it does mean the FDA approved them without knowing whether they are more likely to help patients than hurt them,” the authors wrote.

More than a quarter of the drugs were for cancer, and one in four of those drugs didn’t meet any of the criteria. That’s because companies commonly get cancer drugs approved based on surrogate outcomes, like tumor shrinkage, rather than on clinical outcomes, such as reduced mortality or decreased symptoms.

“Experts say the FDA should have no illusions regarding the unreliability of such surrogate outcomes, especially since these outcomes fail to take into account the harms a drug may cause, such as liver failure and anemia,” the authors wrote.

A notable example includes the agency’s accelerated approval in 2008 of the drug Avastin to treat metastatic breast cancer.

Made by Genentech and marketed by Roche, Avastin netted $6.8 billion by 2010. Eventually, five clinical trials failed to show any clinical improvements for patients on the drug. Instead, they showed the drug caused blood clots, perforated intestines, stroke, heart problems and kidney malfunction.

The FDA eventually withdrew its approval of the drug in November 2011, but in the process, the agency and patients were attacked and harassed by the drugmakers. The FDA has since been reluctant to withdraw approval for drugs, according to The Lever.

Drugmakers that get drugs approved today on the accelerated pathway are supposed to conduct post-marketing trials to confirm the safety and effectiveness. However, more than one-third of those approved drugs have never had such a trial.

“The FDA continues to approve medicines based on evidence as flimsy, contradictory, and inadequate,” the authors wrote. “Citing the need for ‘flexibility’ and the importance of encouraging drug development when there are few treatment options, the agency has all but abandoned its hard-won standards for sound science, according to numerous experts.”

What about vaccines? 

The Lever created a database that readers can search to determine how many of the four criteria drugs approved between 2013 and the end of 2022 meet.

The list — and the investigation — does not include vaccines.

Children’s Health Defense Senior Research Scientist Karl Jablonowski said vaccine trials have similar variability in meeting the criteria laid out in The Lever investigation.

He added that even clinical trials that might claim to meet the criteria often do so “in name only.”

For example, testing against placebos that are other vaccines or that include the adjuvant contained in the vaccine doesn’t provide true safety data.

He said:

“A placebo specifically does not have a medical effect, except in vaccine research where the ‘placebo’ may constitute all the excipients [components added as preservatives or to increase effectiveness] less the antigen. The excipients contain the chemicals, or adjuvants, that agitate the immune system and get it to pay attention to the antigen.

“The more alarming the adjuvant is to the immune system, the more likely it is to create durable immunity to the co-administered antigen. But adjuvants are really nasty chemicals, and are by no means a healthy baseline.”

Jablonowski also said clinical trials aren’t always blinded, even if they claim to be. For example, the Pfizer-BioNTech study of the COVID-19 vaccine shows that the number of patients who withdrew from the study was 45% greater in the placebo group than in the vaccinated group.

“Statistically, there is a 0.02% chance that the study was actually blinded, or 99.98% chance it was unblinded,” Jablonowski said.

Many vaccines test for antibodies, rather than for protection against disease. “The more uncommon a disease is, the larger a trial must be to capture statistical significance,” according to Jablonowski.

Other vaccines, like Merck’s HPV vaccine Gardasil, which the company touts as protecting women against cervical cancer, were never clinically tested against cancer outcomes, because it takes such cancers a long time to develop.

“There is no such thing as a prospective 30-year clinical trial, so the HPV vaccine was approved without establishing the primary clinical outcome,” he said.

Related articles in The Defender 

Brenda Baletti, Ph.D.

Brenda Baletti, Ph.D.

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

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