Archive for July, 2022

Hydrogen Peroxide for COVID Shown to Work in Hospital Study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9113766/

2022 Aug; 126: 103–108.
Published online 2022 May 18. doi: 10.1016/j.jhin.2022.05.007
PMCID: PMC9113766
PMID: 35594985

Further observations on hydrogen peroxide antisepsis and COVID-19 cases among healthcare workers and inpatients

Abstract

Background

The use of prophylactic antisepsis to protect against coronavirus disease 2019 (COVID-19) has been suggested. This study investigated hydrogen peroxide antisepsis (HPA) at two hospitals in Ghana.

Methods

Cases of COVID-19 among healthcare workers (HCWs) using hydrogen peroxide (HP-HCWs) or not using hydrogen peroxide (NHP-HCWs), vaccinated or unvaccinated, were recorded at Shai-Osudoku Hospital (SODH), Dodowa, and Mount Olives Hospital (MOH), Techiman, between May 2020 and December 2021. The effect of HPA in all inpatients at MOH was also observed. Permutation tests were used to determine P values.

Findings

At SODH, there were 62 (13.5%) cases of COVID-19 among 458 NHP-HCWs but no cases among eight HP-HCWs (P=0.622) from May to December 2020. Between January and March 2021, 10 (2.7%) of 372 NHP-HCWs had COVID-19, but there were no cases among 94 HP-HCWs (P=0.206). At MOH, prior to HPA, 17 (20.2%) of 84 HCWs and five (1.4%) of 370 inpatients had COVID-19 in July 2020. From August 2020 to March 2021, two of 54 (3.7%) HCWs who stopped HPA had COVID-19; none of 32 NHP-HCWs contracted COVID-19. At SODH, none of 23 unvaccinated HP-HCWs and 35 (64%) of 55 unvaccinated NHP-HCWs had COVID-19 from April to December 2021 (P<0.0001). None of 34 vaccinated HP-HCWs and 53 (13.6%) of 390 vaccinated NHP-HCWs had COVID-19 (P=0.015). No inpatients on prophylactic HPA (total 7736) contracted COVID-19.

Conclusion

Regular, daily HPA protects HCWs from COVID-19, and curtails nosocomial spread of SARS-CoV-2.

Results

The use of HPA was beneficial to both vaccinated and unvaccinated HCWs, and offered significant protection for both groups at SODH. HPA also curtailed nosocomial spread of COVID-19 at MOH. No COVID-19 deaths occurred among HCWs during the period of observation. No adverse events of the use of HPA were reported.

The concentration of hydrogen peroxide used for mouthwashing/gargling was 1%, and the concentration used for nasal rinsing (two drops per each nostril) was 0.5%. The duration of mouthwashing and gargling, and nasal rinsing was 1 min. At SODH, HPA was practised daily, except during peak periods of SARS-CoV-2 transmission when some HCWs resorted to twice-daily application.

Hospital Study Shows This Can Prevent COVID-19 Infection

Analysis by Dr. Joseph Mercola
July 23, 2022

Story at-a-glance

  • A hospital study published in June 2022 revealed that hydrogen peroxide (H2O2) mouthwash, gargle and nasal rinse protected against COVID-19 better than the jab
  • When food grade H2O2 is nebulized for approximately 30 minutes in normal saline it also reaches your sinuses and lungs where it can kill the virus, augment your natural defense system and may help stop an ongoing infection in the lungs and upper respiratory tract
  • Taxpayers recently spent $275 million, or $1,833 per dose, on a new monoclonal antibody drug. It is approved for people who are most vulnerable and at high risk for progression to severe disease despite the risks not being known at this time
  • Paxlovid is another drug purchased with taxpayer dollars at up to $530 per five-day course of treatment. People are requiring a second course of treatment when the infection rebounds with worse symptoms, as it did with quadruple-vaccinated Dr. Anthony Fauci
  • Although health authorities would like to keep you chained to new and not thoroughly tested drugs, you have choices including highly successful protocols that cost less and use supplements and drugs that have been sold for many years

Most health experts agree that early and aggressive treatment for COVID-19 helps to reduce the potential for long COVID symptoms and reduces the risk of severe disease. From the beginning, the pharmaceutical industry has sought to develop new and expensive antiviral drugs to treat the coronavirus responsible for COVID-19 with an aim at profits. The newest drug — monoclonal antibody treatment bebtelovimab from Eli Lilly1 — is no exception.

For example, Dr. Anthony Fauci’s favorite drug used early in the pandemic on hospitalized patients — remdesivir — cost the taxpayers over $70.5 million to develop.2 A five-day course of treatment costs private insurance companies $3,120 and the government $2,340,3 which is doubled at $6,240 for private companies and $4,680 for the government for a 10-day course.

This is well above the drug maker’s estimated cost for production, which is between $10 and $600 for a 10-day course.4 Fauci, who is the director of the National Institute of Allergy and Infectious Disease (NIAID), has been the face of the public health initiatives against COVID since the pandemic was announced by the World Health Organization in March 2020.

In the first year or more of the pandemic, patients were told to suffer at home until they were near death and then go to the hospital where they were placed on deadly ventilator treatment.5,6

In my interview with Dr. Pierre Kory,7 one of the leaders in the movement to provide early treatment for COVID infection, he recalled how he refused to remain in leadership at the University of Wisconsin Medical Center where the hospital insisted on providing supportive care only to their patients.8

However, as the pharmaceutical industry has released a variety of drugs or treatments, including monoclonal antibodies, Paxlovid and remdesivir, the perspective has changed.

Hospitals and physicians now offer pharmaceutical treatments approved under emergency use authorization (EUA) with unknown long-term side effects but continue to refuse to use well-established drugs with known side effect profiles that have proven to be effective. Hydrogen peroxide is one of those preventive measures and treatments.

Hospital Study Shows H2O2 Prevents COVID-19

In August 2022, a study9,10 of over 4,000 patients and 89 health care staff in a hospital in Ghana revealed the results of those who used hydrogen peroxide (H2O2) mouthwash, gargle and nasal rinse daily as a preventive against COVID-19.11

The researchers compared the data between two hospitals in Ghana where individuals who were vaccinated or not vaccinated either used H2O2 prophylactically or did not. The effect on inpatients was also recorded. They found that in the 89 health care staff members who used the H2O2 preventively, only one contracted COVID-19 and that person had discontinued using the rinses.

None of the greater than 4,000 patients who were treated with H2O2 got COVID-19. In another hospital, 424 staff members were fully vaccinated; 34 of those used hydrogen peroxide and none developed COVID-19. Of the remaining 390 health care staff, 53 developed COVID-19.

In another group of 78 unvaccinated staff, 23 used hydrogen peroxide and none of them contracted COVID-19. In the remaining group, 35 got COVID-19. The results from this study suggested that H2O2 was more effective at preventing COVID-19 than the jab.

The participants used 1% hydrogen peroxide mouthwash and diluted hydrogen peroxide to 0.5% for the nasal cavity rinse. The treatment was done only once daily.

The researchers concluded, “Regular, daily HPA [hydrogen peroxide antisepsis] protects HCWs [health care workers] from COVID-19 and curtails nosocomial spread of SARS-CoV-2.”12 This is important since infections in the hospital are more easily transmitted when staff have greater face-to-face exposure with patients and each other.

The data from the August 22 study confirmed an earlier observational report13 by the same team on two groups of health care workers. In the earlier results, the researchers found that 89 of 944 health care workers who did not use hydrogen peroxide tested positive for COVID-19 in the study period. During the same time, 154 health care workers used the hydrogen peroxide treatment and 100% of those tested negative.

A Nebulizer Drives the Hydrogen Peroxide Even Deeper

In April 2021, I interviewed Dr. Thomas Levy,14 board-certified cardiologist who is best known for his work with vitamin C. We discussed the use of nebulized hydrogen peroxide, which has become my favorite intervention for the treatment and prevention of viral illnesses.

H2O2 is part of your body’s natural defense system, so using nebulized H2O2 just augments your body’s natural defense system. However, as I discuss in the video above, it’s essential that you mix the solution appropriately, use normal saline to protect your lung tissue and use the treatment until all the fluid in the chamber has evaporated, often taking approximately 30 minutes.

Nebulized hydrogen peroxide also requires the use of a food-grade product that does not have the stabilizers and chemical preservatives found in the H2O2 bottle on drugstore shelves. It is also important to use distilled water or saline, since tap water can contain a deadly amoeba.15 Your gastrointestinal tract can adequately take care of this pathogen but inhaling it into your lungs can cause significant damage.

One of the benefits of nebulizing hydrogen peroxide is that it disperses the H2O2 throughout your mouth, nasal cavity, sinuses, throat and lungs. This is especially powerful if you have been exposed to a viral illness or are sick.

Nebulized H2O2 can help kill viral particles in your respiratory tract but does not reach any viral particles in the rest of your body. Therefore, using nebulized H2O2 after exposure or in the early hours of a respiratory infection may help stop an infection in its tracks.

If you miss the early window to prevent an infection, using the treatment also helps to protect your lungs from developing pneumonia, which can be deadly in those with COVID-1916,17 or flu.18

Taxpayers Spend $1,833 per Dose on Monoclonal Antibody Drug

In February 2022, the FDA19 approved an EUA for a new monoclonal antibody treatment for the COVID-19 omicron variant. The drug — bebtelovimab — was developed by Eli Lilly. The government immediately ordered 600,000 doses, spending $1.08 billion or $1,800 per dose.20 According to Endpoint News,21 another order for 150,000 doses was approved for $275 million, the equivalent of $1,833 per dose.

The $33 per dose increase in price occurred in just four months. While this may not sound like a lot of money for a single dose, spread over 150,000 doses it means the U.S. taxpayers shelled out an extra $4.9 million for the same drug just four months later.

According to the announcement by the FDA,22 the EUA was approved for the treatment of mild to moderate infection in adults and children 12 years of age and older who are at least 88 pounds. The individuals must have a positive COVID-19 test and have indications that they are:

“… at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.”

In other words, for an illness that has a track record of 99% recovery,23 the U.S. government has thus far spent $1.35 billion on 750,000 doses of a drug that by the FDA’s own evaluation should only be used for individuals who are at high risk of severe COVID-19.

According to CDC data24 there were a total of slightly over 1 million deaths from COVID-19 over a 2.5-year period. However, as even the CDC has admitted, many of the deaths attributed to COVID-19 have actually been people died WITH COVID-19, not FROM it.

One of the more infamous cases of death certificates recording a COVID death was from a motorcycle accident,25 which may have been following the CDC’s own guideline for reporting deaths:26

“In cases where a definite diagnosis of COVID cannot be made but is suspected or likely (e.g. the circumstances are compelling with a reasonable degree of certainty) it is acceptable to report COVID-19 on a death certificate as ‘probable’ or ‘presumed.'”

As has been widely reported, while the omicron virus is more transmissible, it is also less virulent and doesn’t cause the severe illness that the variants before it.27 Additionally, if the government drinks their own Kool-Aid, those who are vaccinated are protected from severe disease.28

Thus, there should be no need for 750,000 doses of a monoclonal antibody that should only be prescribed to those at “high risk”29 of severe illness. Added to this, Drugs.com reports, “Not many people have received bebtelovimab. Serious and unexpected side effects may happen. All of the risks are not known at this time.”30

Rebound Illness After Antiviral Paxlovid

Fierce Pharma31 reported that Pfizer also scored a huge deal when the U.S. doubled their order for the antiviral Paxlovid from 10 million to 20 million courses of treatment. The first 10 million cost the U.S. taxpayers $5.29 billion and contributed to Pfizer’s anticipated revenue of $101.3 billion in 2022.

Fierce Pharma32 also reported that one analyst, writing to clients, reported that Paxlovid had a “leg up” on molnupiravir because of its “superior efficacy and safety profile.”

Paxlovid joins a long list of drugs developed specifically for COVID-19 that have not proven to be effective. Reports are emerging33 that patients treated with a five-day course will sometimes experience severe rebound when the course is completed. Government officials are planning to study the rate of rebound, the extent to which the drug causes rebound and whether a longer regimen will reduce the effect.

Virologist David Ho described the post-Paxlovid rebound he experienced in April to Bloomberg.34 After getting sick, his doctor prescribed Paxlovid. Days later his symptoms dissipated, and the tests were negative. However, 10 days after getting sick, the symptoms returned and the tests were positive again.

He sequenced the virus in his body and found that the infection before and after taking Paxlovid were from the same strain, confirming that the virus didn’t mutate or become resistant to the drug. Pfizer, meanwhile, insists the increase in viral load post-treatment “is unlikely to be related to Paxlovid” because viral rebound was found in “a small number” of both the treatment and placebo groups in Pfizer’s final-stage study.35

Subsequently, quadruple-vaccinated Fauci reported that he tested positive for COVID-19 and experienced mild symptoms.36 Reportedly his age placed him at high risk for complications and he was then prescribed Paxlovid.37 CNN reported he described the “interesting course” of his COVID-19 infection during an appearance at Foreign Policy’s Global Health Forum.

Fauci told the group that after five days he was negative for three consecutive days on an antigen test. Apparently, three negative tests weren’t enough, so he tested himself again on the fourth day “just to be absolutely certain.” By that time, he had reverted to a positive test. “It was sort of what people are referring to as a Paxlovid rebound,” he said.38

Low Cost, Low Side Effect, Effective Treatment Available

Fauci reported that his symptoms were worse when they returned the second time after treatment. He was prescribed another course of Paxlovid and at the time of the interview, he was on day 4 of a 5-day course. He reportedly felt “reasonably good” although “not completely without symptoms.”39

The cost of Paxlovid can be as much as $53040 for a five-day course, but consumers get it for “free” since it was purchased with their tax dollars. During these past two years, the government has spent billions of dollars buying medication for an infectious illness that has been proven to be successfully treated at home using far less expensive medications and supplements.

For example, the overall survival rate across all age groups and all risk strata is 99%, but the Zelenko Protocol41 has demonstrated a 99% survival rate in high-risk patients. His published treatment protocol includes over-the-counter supplements vitamins C and D3, elemental zinc and quercetin for low-risk patients.

Patients who have a moderate or high risk of severe disease are treated with vitamin C and D3, elemental zinc, azithromycin, doxycycline, hydroxychloroquine and ivermectin.

The Front Line COVID-19 Critical Care Alliance42 has developed several protocols43 aimed at prevention, early treatment, long-haul COVID treatment, post-vaccine recovery and hospital treatment. First-line therapies in early treatment include over-the-counter zinc, vitamin C, melatonin, quercetin, probiotics, curcumin, aspirin, mouthwash and nasal spray. Prescription medications include ivermectin and hydroxychloroquine.

Both protocols are highly successful with known side effect profiles since the medications and supplements have been used for many years. Both protocols are based on the premise that early treatment can reduce the risk of long-haul COVID symptoms and the potential to develop severe disease. Most of the therapies are inexpensive and easily purchased over the counter.

The Front Line COVID-19 Critical Care Alliance44 also maintains a list of physicians who follow the protocols and provide in-office and telehealth services. I believe one of the most powerful strategies you can use preventively and in early treatment is nebulized hydrogen peroxide.

As the featured study demonstrated, even with store-bought hydrogen peroxide diluted for nasal wash, mouthwash and gargling once daily, you can effectively prevent infection. Although health authorities would like to limit your treatment choices and keep you chained to new and not thoroughly tested drugs where “all the risks are not known at this time,”45 you have choices and can take control of your health.

For more:

To TBDWG: Pay Attention to Gestational Lyme & New ICD-11 Codes

https://www.lymedisease.org/bauer-gestational-icd11-tbdwg/?

To TBDWG: Pay attention to gestational Lyme and new ICD-11 codes

Kristina Bauer gave the following public comments at the July 19 meeting of the federal Tick-Borne Disease Working Group.

July 21. 2022

I’m Kristina Bauer, Executive Director of Texas Lyme Alliance,  mom of four gestational Lyme kids. This is my fourth opportunity to address Congress and provide public comments to the TBDWG, thank you for giving patients and advocates a voice!

I have been advocating for gestational and pediatric Lyme over five years, yet still don’t see treatment guidelines updated to avoid this health risk. I went 32 years misdiagnosed as autoimmune diseases and hearing, “I don’t know how to help you.”

My family is finally in remission after 10 years of treating by using immune therapies and integrative medicine, spending too much money. I also serve on the board of Mothers Against Lyme, and am the Texas state captain for Center for Lyme Action.

* The Affordable Care Act established that 90 days of antibiotic treatments, repeated as necessary, are essential health benefits for cases of persistent and recurring Lyme infection.

* Dr Bruce Patterson’s work from Incelldx on chronic inflammation has inferred Lyme persists, but others may need treatment for high inflammation. Separating these two can help patients identify what is going on and reduce symptoms to improve quality of life.

* I invite the listeners to view my YouTube channel at Kristina Bauer that contains interviews regarding how PTLDS is being expressly used to deny treatment for ongoing infection.

* Human rights violations have been documented to include denying the right to the highest attainable standard of health, personal security, right to life and the protections against torture and cruel, inhuman and degrading treatment.

* Doctors who take an oath but don’t understand Lyme, do nothing for patients, therefore in fact do harm. Improving education to all medical providers would help improve a patient’s quality of life.

ICD-11 Diagnostic Codes

The World Health Organization’s ICD-11 now recognizes a significant number of Lyme complications which can become chronic, cause severe disability, and in some cases, result in death.

The new codes now include: 1C1G.10 Lyme Neuroborreliosis. 1C1G.11 Lyme Carditis. 1C1G.12 Ophthalmic Lyme borreliosis. 1C1G.1Y Other specified disseminated Lyme borreliosis. 1C1GY Other specified Lyme borreliosis. 6D85.Y Dementia due to Lyme Disease. 8A45.0Y Central Nervous System demyelination due to Lyme borreliosis and WHO recommended that “KA6Y Other specified infections of the fetus or newborn” be coordinated with “XN13C Borrelia Burgdorferi” to represent congenital Lyme.

Thank you to all TBDWG members. To all the patients, things ARE getting better, keep your chin up and never give up!

View a recording of Kristina’s comments here:

Kristina Bauer can be contacted via her website, TXLymeAlliance.org.

________________

**Comment**

Moms like Kristina are true, unrecognized heroes.  Having a bevvy full of infected kids, while being infected yourself is a underappreciated challenge.  Rock on!

That said, here’s a few points for consideration:

  1. The TBDWG does NOT give patients a voice – unless you consider ONE patient advocate enough of a voice.  As knowledgeable as LDA’s Pat Smith is, one voice hardly registers against a literal Cabal biased against the severity and persistence of Lyme/MSIDS.
  2. Being misdiagnosed for 32 years is unacceptable but nothing is changing in Lyme-land and the exact same thing is happening to thousands of others daily.
  3. This brave mom discusses having FOUR children with gestational Lyme, yet the CDC still says this is rare.  As Tuttle asks, how can they know when they aren’t counting?
  4. Doctors saying “I don’t know how to help you” is also unacceptable.  They are either too afraid to treat due to the politicization of the disease OR are completely ignorant due to public health ‘authorities’ who are  propagating a false narrative that has been regurgitated by mainstream medicine, including medical professional organizations (they come after doctors for thinking for themselves) and medical schools (which are in bed with Big Pharma) – all of which are slowly turning into a monopolized business that is completely destroying health care.
  5. Working with the corrupt WHO is unfruitful at best and harmful at worst.  70% of its funding comes from Big Pharma and the rest comes from the Gates Foundation and China.  Hello?  A WHO whistleblower has stated the WHO is the “tip of the spear for world tyranny.”  Why do we continue to craw in bed with the enemy?  If we haven’t learned from 40 years of stagnation and lies, we never will.
  6. The Affordable Care Act (aka: ACA, Obamacare, PPACA) is not affordable.  Further, this monopoly has caused untold damage.  Again, why would you continue to trust the very people and agencies behind all the corruption?  It defies all sound logic and reason.  Untold thousands have died and continue to die, due to ACA interference with COVID treatment. I can only imagine the suffering due to the standard Lyme guidelines in place for over 40 years.
  7. Things are NOT getting better.  There is a delusion in the land and people have stopped thinking critically.  We need to quit aligning ourselves with corrupt bureaucrats who care more about their position, power, and money than patients. Any forward progress has been solely due to independent researchers/doctors who conduct their own research with their own funds and/or share with the world what they have learned in their clinical experience That’s it.  If we were smart, we would fund these individuals and organizations.  The government is beyond help.  Time to move on and get real answers for patients. “Insanity is doing the same thing over and over and expecting different results.”  Truer words were never spoken and never more applicable than in Lyme-land.
  8. Always keep your chin up and never give up.  But we also must get wiser and realize what is working and what is not, and stop enabling corrupt organizations to continue to do what they’ve gotten away with for decades.

Neurologist Weighs in on Spate of SADS: “We Should Be Doing Autopsies on Every Single One”

https://jennifermargulis.substack.com/p/we-should-be-doing-autopsies-on-every

“We Should be Doing Autopsies on Every Single One”

A neurologist weighs in on the spate of sudden adult deaths

Robert Lowry, M.D., is a concussion and musculoskeletal expert who has been practicing medicine for over 25 years. When I spoke with him by phone last week, Lowry told me he’s seen an upsurge in young patients—adults under 40—coming to him with neurological problems.

These problems, he said, include everything from severe headaches to Bell’s palsy (facial paralysis) to strokes.

In every case he has seen, Lowry said, his patient was vaccinated. For this reason, he believes these neurological issues are actually COVID-19 vaccine adverse events.

Data From Mexico

Lowry pointed me to a 2021 article in Clinical Immunology that analyzed vaccine injury data from Mexico.

The study authors found that about 1 percent of people who got the first dose of the Pfizer vaccine reported having adverse neurological events afterwards.

Less than one percent. No problem. Right?

But, Lowry argued, that number is likely underreported by a factor of 10. And, he insisted, even if it is accurate, that percentage of adverse neurological events is simply too high to justify vaccination in otherwise healthy young adults.

(See link for article)

____________________

SUMMARY:

  • If 2/3 of the population got one dose, that is 5.3 billion people.  1% of 5.3 billion equals 53 MILLION who have likely already suffered from neurological injury.
  • You can calculate your risk of dying from COVID-19 by entering your age, place of residence, and underlying health issues into an online risk calculator.
  • Since the risk of dying from COVID for young adults is less than 1%, risk of injection damage outweighs any supposed benefit.
  • Healthy people are suddenly dying (SADS) in numbers never seen before.
  • When the deaths are “unexplained” but a history of vaccination within the past 12 months, Dr. Lowry believes the cause is likely the mRNA vaccines.
  • Physicians are seeing many more severe reactions and neurological and cardiac injuries after the second dose.
  • The most likely ways include micro-clots in the brain that result in neuron necrosis; myocarditis, pericarditis and other heart damage; and vasculitis (inflammation of the blood vessels), but is compounded by immuno-sensitivity.
  • The best way to find out the cause of these cases is by doing autopsies, and Lowry believes autopsies should be done on every single one of these healthy people who died suddenly.

Please note that Fauci told the government to tell others to NOT do autopsies on COVID patients.  Doctors are asking where the autopsies are of those who died after the COVID shots. Embalmers are showing blood clots and white, fibrous structures in the “vaxxed,” and that hospitals are covering up the deaths of babies by cremating them in house.

Autopsies would also give answers in Lyme-land.

FDA Still Working to Stifle Lab Testing Options

https://anh-usa.org/fda-working-to-stifle-lab-testing-options/

FDA Working to Stifle Lab Testing Options

FDA Working to Stifle Lab Testing Options

Another dangerous policy has been slipped into legislation that must pass Congress by the end of September. Action Alert!

For months now, we’ve been telling you about the dangers of mandatory product registration for supplements; one key threat is that this policy has been snuck into the reauthorization of drug user fees which must be approved by the end of September. Another bad policy has been tacked on to this must-pass legislation. It represents another attempt by the FDA to extend its power over laboratory developed tests (LDTs). This is a critical threat, as LDTs are crucial tools used in personalized medicine because labs can create custom diagnostic tests for all sorts of diseases. We cannot allow the FDA to stifle innovation in this sector and regulate these tests out of existence.

LDTs are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, companion diagnostics, and also diseases like COVID-19.

The LDT policy that has been snuck into PDUFA is the VALID Act. It creates a risk-based framework for the FDA to regulate LDTs in which “high-risk” LDTs would undergo premarket review, whereas LDTs determined to be “low-risk” would have less scrutiny and could qualify for exemptions to premarket review. High-risk tests are those for which an inaccurate result has a high likelihood of resulting in serious harm or death to patients or is likely to delay life-supporting treatment. The policy allows FDA to revoke pre-market exemptions if new information comes to light indicating greater risks to patients. Generally, LDTs currently being offered are grandfathered in and would not need to undergo premarket review, though they would need to adhere to the bill’s other requirements.

Premarket review for these tests is a big mistake. We saw this in stark relief during the COVID-19 pandemic. At the beginning of the pandemic, labs were held up from developing their own COVID tests because they needed to get emergency use authorization—in essence, pre-approval—to deploy their tests. This was a major missed opportunity; accurate testing is important, but the FDA prioritized red tape over getting people reasonably accurate means of testing for COVID that could have helped reduce transmission rates and hospitalizations at an earlier date.

Premarket review for LDTs will also stifle innovation in an exciting medical sector. Regulators are often suspicious of new products. The agency is also more influenced by older firms offering old technology. Protecting them can also lead to lucrative jobs after leaving government. This is the old crony capitalist conundrum.

The policy comes with a litany of other requirements for LDTs. For example, the FDA can require labeling, advertising, post market surveillance, and other things it deems necessary to detect and mitigate adverse events. Like Sen. Durbin’s mandatory product listing for supplements, the policy also requires all LDTs to register with the FDA—a requirement that will pose a significant time and personnel burden on laboratories that are already stretched thin and short-staffed.

The policy also calls for the development of a user fee program whereby testing companies pay the FDA to review their tests. This is another bad idea, as it privileges large, commercial test developers over smaller labs (non-profit labs, academic labs, etc.).

The FDA has tried before to put LDTs under its thumb. It claims to have some statutory authority over LDTs, but for decades chose not to regulate them as other diagnostic devices. LDTs have historically been regulated by the Centers for Medicare and Medicaid Services (CMS). But in 2014, the FDA issued a draft guidance saying it would regulate LDTs as medical devices. Congress pushed back, with some legislators arguing that the FDA’s approach to LDTs was “redundant, [would] raise costs and stifle innovation, and [would] require additional taxpayer funding to the FDA.”

To us, it seemed clear that the FDA wants to take over LDTs in order to maintain the monopoly enjoyed by hospitals together with two companies: LabCorp and Quest Diagnostics. Given new authorities over LDTs, the agency would likely approve only those tests that big companies have a legal right to perform and are inclined to offer, and which insurance companies and Medicare will pay for.

LDTs are the future of medicine. People are already able to test for and spot cancers long before they manifest themselves using current methods. These tests are improving at a rapid rate. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases. LDTs are not only the future of general medicine—they are also the future of individualized medicine, which is an exciting and important development. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—this information could not be gathered and analyzed otherwise.

We cannot let the FDA regulate these tests out of existence.

Action Alert! Write to Congress and tell them to oppose the VALID Act’s inclusion in the FDA user fee reauthorization bill. Please send your message immediately.

Go to top link to fill out a form to send to your representatives.

__________________

**Comment**

Hopefully the past few years have clearly demonstrated the problem with centralized, monopolized, government sanctioned testing under the auspice of “public health” that can and will be used to take away your freedoms and rights. This faulty testing has kept people from working, going to school, and partaking in society in general.

Lyme-land has similarly been in a testing juggernaut for 40 years – clearly showing the outcome of CDC/FDA propaganda and the underlying conflicts of interest that drives everything about public health.  Similarly to COVID, Lyme testing was created (and is still being used) that eliminated the most specific band for Lymedue to vaccine development.  A case definition (also still being used) was created to fit this faulty, unscientific paradigm that has ruled like an Iron Curtain ever since.  Truthcures has met with the FDA in an attempt to ameliorate this but 40 years is a long time to suffer with no change.

And speaking of testing corruption: A NYC company, owned by family who donated $300K to NY governor Hochul, paid $637 MILLION to manufacture at home COVID tests without considering bids from competing manufacturers and without a contract.

The FDA has been coming after CLIA-certified labs such as IgeneX since it opened its doors.  The CDC also has maligned these smaller specialized labs from the top down.  Their website used to have a paragraph that called them “home-brewed” tests.  I actually heard a pediatrician speak at the Wisconsin state capital who used this exact phrase.  Doctors have been brain-washed that these CLIA-certified labs, which undergo far more rigorous lab requirements than Lab Corp or Quest, are quackery.  The pediatrician’s statement is indicative of this propaganda process.

Ask yourself one question: why won’t doctors in mainstream medicine utilize Galaxy or IgeneX testing? 

The answer is clear: they’ve been told not to.  Who is telling them?  The CDC/FDA and other government agencies are monopolizing medicine through the CARES Act, which in turn controls doctors like puppets.  This is why people are not being treated with ivermectin, HCQ/zinc, IV vitamin C, and other known, effective treatments and why people are resorting to the court system to save their loved ones in the nick of time.

This exact scenario plays out in Lyme-land on a daily basis.

Lyme/MSIDS, similarly to COVID, has become so politicized that doctors are afraid to treat patients. Instead, they fearfully toe the CDC/FDA line by using their sanctioned tests, treatments, and guidelines – all of which are completely and utterly worthless.

Our only hope are brave, independent doctors who have chosen to step outside the corrupt, fraudulent medical monopoly to do what they started out to do: uphold the Hippocratic oath by treating patients as they see fit according to their medical training and experience, and defying the corrupt professional organizations that are in bed with the government. These doctors are being harassed, censored, and threatened at every turn but refuse to be silenced. 

The Physical & Financial Devastation of Unrecognized Lyme Disease

https://www.lymedisease.org/ciocca-tbdwg-devastation-lyme/

03 MAY 2022

The physical and financial devastation of unrecognized Lyme disease

Caroline Ciocca delivered the following public comment to the federal Tick-Borne Disease Working Group on April 27.

My name is Caroline and I am 25 years old. I grew up in Pennsylvania and moved to North Carolina after graduating from Temple University with a degree in Risk Management and Insurance in 2019.

I first became ill when I was 9 years old. I presented with mostly gastrointestinal and neuropsychiatric symptoms, which my pediatricians dismissed as mental illness despite the recommendation from my child psychiatrist that I be tested for Lyme.

Despite years of unexplainable symptoms that frequently debilitated me, I went undiagnosed for 15 years until the age of 23. At this time my symptoms progressed to the point that I could barely stand up without passing out and I would get to the end of the day and have no recollection of what happened, and still I was told I was just anxious.

The results of my Western Blot still left me in a gray area. The hospital called me weeks later to tell me my test was “not positive, but not exactly negative,” with no guidance on what to do about that.

Alongside Lyme disease, I have also been diagnosed with associated infections of Babesia, Bartonella, and mycoplasma. It is extremely common for patients to be infected with multiple pathogens, yet the co-infections are rarely recognized for how common and also how damaging they are.

I struggle every day with regional pain in my ankles, knees, and hips that leaves me unable to walk. Nausea to the point I lost 35 pounds in a year and dropped to 95 lbs, so underweight I stopped getting my period. I had to have my gallbladder removed. Headaches, jaw pain, eye problems, mood instability, panic attacks, and PTSD from my traumatic experiences trying to navigate the medical system for so many years.

The disease has impacted my neurological system, causing severe memory loss, brain fog, failure to recall words, confusion, executive functioning issues, and disorientation.

Financial devastation, too

Like so many other patients, I not only suffer from the physiological devastation, but also the financial devastation of this illness. I have spent hundreds of thousands of dollars on medical costs throughout the years.

I am now unable to work and had to leave my first full time job out of college. I have had more than $15,000 in out of pocket medical costs in the last MONTH alone, which is a continuation of ongoing treatment that is expected to cost $60-80k out of pocket.

There are a number of things that could have been done differently to impact my journey with this disease. The Working Group should consider the following action items:

  • Investigating what role co-infections and other commonly associated vector-borne diseases such as Bartonella play in the clinical presentation and pathogenesis
  • Funding to update education and guidelines on government-funded sites for healthcare professionals on all aspects of this illness- especially neuropsychiatric manifestations
  • Outreach to communities to stress the importance of prevention, early intervention and treatment, and potential long term health impacts – especially for at-risk demographics such as children

I am confident that had measures like this been put into place, I would not be here speaking on this topic right now. I would not have had my childhood robbed from me or had to put the last two years of my life on hold while accumulating tens of thousands of dollars in medical debt.

There is a unique opportunity here to change the lives of the hundreds of thousands of people being diagnosed every year. Thank you for your time.

Caroline can be contacted via ciocca.caroline@gmail.com.

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Seriously, how many more stories must be shared before this becomes recognized for the global plague it truly is?