FDA At it Again By Threatening MS Treatment

August 19, 2022

As most of you are aware, MS can be undiagnosed Lyme, and/or other infections.

https://anh-usa.org/fda-threatens-multiple-sclerosis-treatment/

FDA Threatens Multiple Sclerosis Treatment

 By ANH-USAOn 0
FDA Threatens Multiple Sclerosis Treatment

Clinical trials testing estriol for the treatment of multiple sclerosis show great promise…but the FDA is threatening to ban the only way patients can access this critical medicine. Action Alert!

Estriol is one of three main estrogens produced by the body, alongside estrone and estradiol. It is often used by integrative practitioners for its benefits to menopausal women, but recent investigations show that it may be effective in the treatment of multiple sclerosis (MS). Despite these health benefits, the FDA is poised to eliminate access to estriol and other bioidentical hormones made at compounding pharmacies. We cannot let this happen.

Estriol levels skyrocket during pregnancy, and many MS patients go into remission during pregnancy. Researchers have noted estriol’s anti-inflammatory and neuroprotective properties. This has culminated in clinical trials testing estriol as a treatment for MS, and the lead researcher on this trial recently said that so far, results have been “promising.”

Many studies have shown that estriol offers many other potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer.

Unfortunately, such a breakthrough may become moot if the FDA goes through with a ban on estriol and other compounded bioidentical hormones. Currently there are no FDA-approved estriol products; the only way patients can get estriol is through a compounding pharmacy.

Recall that the FDA is currently in the process of determining whether to ban estriol and other hormones from being made at compounding pharmacies. After ANH and other stakeholders mounted a massive grassroots campaign pushing back against this threat, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to evaluate the “clinical utility” of treating patients with compounded bioidentical hormones like estriol. We explained previously how NASEM’s process was heavily influenced by the FDA and outrageously biased against compounded hormones. In its final report, NASEM concluded, unsurprisingly, that widespread use of compounded hormones poses a “public health concern.”

This has no factual basis at all.  A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. What seems to be underway is an attempt to create drug company monopolies. The result may be that women may not be able to obtain estriol at all, even though estriol protects against cancer.

The FDA still has hurdles to overcome before a ban can be issued: the agency has to issue a proposed rulemaking to add these hormones to the Difficult to Compound List. It’s also possible that the FDA could issue a draft guidance that restricts the use of cBHRT as outlined by NASEM’s recommendations.

The time to send a clear message to Congress and the FDA is now. We beat the FDA when they tried to ban estriol in 2008, and we can beat them again, but only if the entire community rises up and holds the agency’s feet to the fire. We cannot let the federal government interfere with our health.

Action Alert! Write to Congress and the FDA urging continued access to estriol and other important compounded bioidentical hormones. Please send your message immediately.

Go to top link to send a message to your representatives.

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**Comment**

The FDA is at it again.  Doing everything but what it should.

The FDA has a long and sordid history of colluding with Big Pharma by attempting to monopolize medicine by erasing anything it considers competition or a threat to its power:

Category:

Activism, Lyme, Viruses

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Lyme Disease & The Effects of Vitamin D

https://www.globallymealliance.org/blog/lyme-and-vitamin-d

Lyme Disease and The Effects of Vitamin D

by Jennifer Crystal on August 16, 2022

<img src="https://www.globallymealliance.org/hubfs/Gala%20PR%20Image%20%2829%29.jpg&quot; alt="Lyme Disease and The Effects of Vitamin D“>
Lyme disease can deplete your vitamin D levels–which ironically, are essential in your recovery. Read about the positive effects of Vitamin D and techniques to increase it.

While kayaking recently, a friend noticed that I was getting a lot of sun on my face and asked if I wanted a hat. “No thanks,” I replied. “I’m wearing sunscreen, and I want to soak up as much vitamin D as I can.”

There were summers during my convalescence from tick-borne illness when I couldn’t be in the sun at all, due to the phototoxicity of the medication I was on. Doxycycline, the most common antibiotic used to treat Lyme disease, can cause you to be very sensitive to the sun. When I was on doxycycline or other antibiotics in the same family, my face would feel like it was on fire if I was exposed for more than five minutes. I spent summers bundled in protective shirts, under hats and umbrellas in the shade.

A former camp counselor who spent every day in the sun before I got sick, summers in the shade were not my style. Now that I am in remission, I want to (carefully) get as much sun as possible, making up for lost time and summer glow. But it’s not just sun-kissed cheeks that I’m after. I literally am trying to soak up vitamin D, provided by the sun, because I know that Lyme disease can cause a deficiency in that vitamin.

The Lyme disease bacteria, Borrelia burgdorferi, directly reduces vitamin D receptor expression in immune cells. Low vitamin D can be involved in immune dysfunction and autoimmunity, so Lyme patients who are already struggling with compromised immune systems may be further compromised by a vitamin deficiency. As Clinical Nutritionist Lindsay Christensen, MS, CNS, LDN, CKNS explains in her blog post “Lyme Disease Nutrition Tips for Optimal Immune Function,” Vitamin D3 is “essential for healthy immune function. Within the innate immune system, vitamin D3 supports the production of cathelicidin, an antimicrobial peptide (protein) that protects the body against bacteria, viruses, and fungi. Vitamin D3 also regulates dendritic cells, which are immune cells that ‘bridge the gap’ between the innate and adaptive immune system branches and may help defend the body against Borrelia.”

In other words, the very vitamin that can be depleted by Lyme disease is also necessary to help fight it.

So what should Lyme patients do? First, make sure your doctor is monitoring your vitamin D levels. A blood test can tell you whether you have a deficiency. If you do, sunshine, and certain foods like egg yolks and fatty cold-water fish, can help you get vitamin D. You also may need to supplement with vitamin D3 to maintain what Christensen describes as “an optimal vitamin D3 level of 40-60 ng/mL, which is higher than the 30-60 ng/mL range suggested by most labs.”

Testing vitamin D levels can also help a Lyme Literate Medical Doctor (LLMD) determine if you have Lyme disease, if you have symptoms but have not yet been diagnosed. Though not a definitive diagnostic marker (low vitamin D is also seen in other conditions like multiple sclerosis), low vitamin D can be a tip-off that Lyme disease could be the cause of your symptoms.

Vitamin D is not the only vitamin that can be affected by Lyme disease, or that you may need more of to help fight tick-borne illness. Many Lyme patients have a vitamin B12 deficiency. Others have anemia or low ferretin. It’s important that your doctor do regular blood work to check for any nutritional deficiencies, and then you can determine together how to best supplement them, to support your overall healing. In the meanwhile, as long as you’re not on a phototoxic drug, sticking your face in the sun can’t hurt!

The above material is provided for information purposes only. The material (a) is not nor should be considered, or used as a substitute for, medical advice, diagnosis, or treatment, nor (b) does it necessarily represent endorsement by or an official position of Global Lyme Alliance, Inc. or any of its directors, officers, advisors or volunteers. Advice on the testing, treatment or care of an individual patient should be obtained through consultation with a physician who has examined that patient or is familiar with that patient’s medical history. *Make sure to protect your skin when in the sun.
Writer

Jennifer Crystal

Opinions expressed by contributors are their own. Jennifer Crystal is a writer and educator in Boston. Her work has appeared in local and national publications including Harvard Health Publishing and The Boston Globe. As a GLA columnist for over six years, her work on GLA.org has received mention in publications such as The New Yorker, weatherchannel.com, CQ Researcher, and ProHealth.com. Jennifer is a patient advocate who has dealt with chronic illness, including Lyme and other tick-borne infections. Her memoir about her medical journey is forthcoming. Contact her via email below.

Email: lymewarriorjennifercrystal@gmail.com

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**Comment**

This is a perfect example of Lyme/MSIDS patients needing to be their own advocates and learning about their own bodies and what they require for optimal health.  It’s a road that never ends so buckle up and enjoy it.

There are times in the journey when this revelation can be overwhelming.  Accept it for the time being and don’t allow it to bog you down.  When you are capable of reading, comprehending, remembering, and searching yourself – do it – you won’t regret learning and improving.  There are many stages to the journey.  You can’t learn it all at once – your head would explode.  So, bit by bit, piece by piece – accrue your knowledge and use it for yourself and to help others.  This is, BTW, the best way to learn.

For more on vitamin D:

Category:

Lyme, Supplements

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September Lyme Support Meeting

When: Sept. 24, 2022

Time: 2:30-4:45

Where:  Pinney Library, Room B, 516 Cottage Grove Rd. Madison, WI

What:  Support and education for Lyme/MSIDS patients

This will be our last support group meeting unless someone steps up to volunteer.  I moved two years ago and have started a group here.  Please consider volunteering for this as support is a vital part of the journey.

I will continue running the website, fielding phone calls, keeping the doctor list updated, and helping anyone that requests it.

I look forward to meeting with all of you and hearing how you are doing.  Please share with the group things that are working for you.

See you soon!

Category:

Meetings

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FDA Buries Head in Sand as 44% of Pregnant Trial Participants Suffer Miscarriages – Then Has the Audacity to Re-categorize Them As “Recovered” Adverse Events

August 18, 2022

https://rumble.com/v1g5nmf-pfizer-buried-their-heads-in-the-sand-as-44-of-pregnant-trial-participants  Video Here (Approx. 3 Min)

44% of Pregnant Trial Participants Suffer Miscarriages

A document released under court order reveals that 44% of pregnant women participating in Pfizer’s mRNA COVID vaccine trial suffered miscarriages.

Dr. Naomi Wolf:

“Over a year ago, the FDA received this report that out of 50 pregnant women, 22 of them lost their babies, and they did not say anything. Thus the FDA was aware of the horrifying rate of fetal death by the start of April 2021 and were silent.”

“If you extrapolate, globally, to all the pregnant women who are injected, it could explain what we’re seeing now of a baby die-off.”

https://rumble.com/v1g5qnt-the-monsters-at-pfizer-recategorized-miscarriages-as-resolved-or-recovered  Video Here (Approx. 1.5 min)

Pfizer Recategorized Miscarriages as “Recovered or Resolved” Adverse Events

Dr. Naomi Wolf:

“Pfizer notes the miscarriages as serious adverse events with moderate or severe toxicity ratings. However, all of them were recategorized, by Pfizer, in the internal documents under the category of adverse events that were ‘recovered’ or ‘resolved.’

The miscarriage is in the same category as a headache that went away. If you lost your baby, Pfizer said, ‘Your adverse event was recovered or resolved.'”

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**Comment**

Remember, the FDA wanted 75 years to release this information, but thanks to a non-profit who sued, a judge has ordered the agency to release 12,000 documents immediately, and then 55,000 pages a month until all documents are released — totaling more than 300,000 pages.

Predictably, Pfizer has stated that deaths in trial participants are “not related” to the ‘vaccine.’ #ABV

They have purposely been obscure and have buried the data making it very difficult to find, but scores of volunteers are pouring through the mountain of documents to unearth the unfathomable.  The icing on the cake is when Pfizer asked the court to dismiss a whistleblower lawsuit because the government was aware of the fraud.  Yes, you read that correctly.  Our government’s collusion with Big Pharma is that blatant.

Now, since data evidently doesn’t even matter, the FDA has waived clinical trials altogether for boosters.  Why even bother?

Please read Dr. Wolf’s Substack article: “Dear Friends, Sorry to Announce a Genocide” where she points out the lies:

  • FDA and Pfizer knew by Dec. 2020 that the mRNA shots waned in efficacy, presented “vaccine failure”, and that a side effect was infection with COVID
  • Pfizer knew by May 2021 that minors can experience heart damage a week after the shot, but the FDA rolled out the jab for teens anyway and parents didn’t receive a press release until August – after thousands were already “vaccinated.”
  • Pfizer knew that the spike protein and the lipid nanoparticles do not stay at the injection site but go directly into the bloodstream and then lodge in the liver, spleen adrenals, lymph nodes, testes, and ovaries.
  • The FDA knew that the Moderna shot has more than three times the 30mcg of the adult Pfizer dose of lipid nanoparticles and spike protein.
    • Pfizer knew there was a higher rate of adverse events with the 100mcg dose so they stopped experimenting with it internally due to its “reactogenicity” but nobody bothered to tell the American people who got the first and second 100mcg Moderna dose AND boosters.
    • Pfizer not only lost hundreds of records of trial subjects but chose females for 3/4 of the subjects because they are less prone to cardiac damage.
    • There were over 42,000 adverse events and more than 1,200 people DIED. Four died on the day they were injected.
    • The FDA and Pfizer knew about blistering, rashes, shingles, and herpetic conditions (blistering conditions oddly foreshadowing monkeypox symptoms)
    • The shots contain PEG, an allergen that causes some to go into anaphylactic shock but nobody, especially those with a PEG allergy, was warned or even watched by their doctor
    • Pfizer’s documents show that “exposure” to the ‘vaccine’ was defined as sexual and skin contact, inhalation, or via lactation.
    • Pfizer BioNTech’s SEC filing shows a fainting side effect so violent you may hurt yourself.  Please consider this when you hear of people “slipping and falling” and hitting their heads.  #ABV

For more:

Category:

Activism, Pregnancy, vaccines, Viruses

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FOIA Request Uncovers Lab Rat Offspring Got Rib Malformations After COVID Shots

https://www.theepochtimes.com/lab-rats-got-rib-malformations-from-covid-vaccine-moderna-trial-documents

Lab Rat Offspring Got Rib Malformations After COVID Vaccination: Moderna Trial Documents

By Enrico Trigoso
August 16, 2022

Moderna documents regarding their COVID vaccine trial on animals, obtained via a Freedom of Information Act request by Judicial Watch, showed that some of the offspring of rats that were injected with Moderna’s mRNA shot developed rib malformations.

The 700 pages contain a portion of the formal Biologics Licensing Application (A) package that a manufacturer is required to submit to the FDA for approval.

The documents have not yet been made public, but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times.  (See link for article)

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SUMMARY:

  • No study report was given, only Moderna’s interpretation of the results done as part of the singular reproductive toxicology test
  • The injection manufacturers didn’t give any dose calculations or justification information for dosage selection
  • Despite results the FDA issued a statement on Jan. 30 saying that there were no adverse effects on postnatal developments
  • The Pfizer shot also caused a 295% increase in abnormal ribs in the offspring of “vaccinated” rats
  • A board-certified OBGYN states that this is an extremely dangerous warning signal which was never brought to the light of day – which means the CDC, Pfizer, Moderna, and prominent medical journals are guilty of lying to the American public and should be held accountable
  • Thorp recently analyzed and verified the most recent Vaccine Adverse Event Reporting System (VAERS) data related to COVID-19 vaccines and compared them to the influenza vaccines, finding numerous abnormalities.  A summary of his findings:
    • increases in menstrual disorders, miscarriage, fetal chromosomal abnormalities, fetal cystic hygroma, fetal malformations, fetal cardiac arrest, fetal cardiac arrhythmias, fetal cardiac disorders, fetal vascular malperfusion abnormalities, abnormal fetal surveillance testing, abnormal fetal growth patterns, placental thrombosis, and fetal death.Compared to influenza vaccines, COVID-19 shots posed the following risks:
      • Abnormal uterine bleeding (menstrual irregularity), 1,000 times greater than for influenza vaccines
      • Miscarriages, 50 times greater
      • Fetal chromosomal abnormalities, 100 times greater
      • Fetal malformation, 50 times greater
      • Fetal cystic hygroma (a major malformation), 90 times greater
      • Fetal cardiac disorders, 40 times greater
      • Fetal arrhythmia, 50 times greater
      • Fetal cardiac arrest, 200 times greater
      • Fetal vascular malperfusion, 100 times greater
      • Fetal growth abnormalities, 40 times greater
      • Fetal abnormal surveillance tests, 20 times greater
      • Fetal placental thrombosis, 70 times greater

Category:

research, vaccines

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