FDA At It Again – Attacking Natural Thyroid

October 6, 2022

https://anh-usa.org/fda-attacks-natural-thyroid/

FDA Attacks Natural Thyroid

 By ANH-USA 0
FDA Attacks Natural Thyroid

For years the FDA has wanted natural thyroid replacement off the market. Now the agency is moving to eliminate individualized versions of this medicine. Action Alert!

The FDA has declared natural desiccated thyroid (NDT) to be a “biologic” and thus ineligible for pharmacy compounding. This is the latest in a decades-long effort by the agency to remove natural thyroid medicines from the market in favor of FDA-approved thyroid drugs that many patients cannot use. This threatens access for millions of patients who need individualized NDT to stay healthy. We need push back against this attack.

The FDA announced this position not in a public statement or guidance, but in a letter to the National Association of Boards of Pharmacy (NABP). The FDA encouraged NABP to share the letter with its members, the state boards of pharmacy, probably hoping that they will do the agency’s dirty work by restricting the compounding of NDT.

We cannot overstate how crucial compounded NDT is to patient health. Almost 30 million Americans are estimated to have a thyroid condition, and about 5 million Americans just haven’t been diagnosed and are not aware they have a thyroid condition. One woman in eight will develop a thyroid condition during her lifetime. So will many men. One of the most common thyroid disorders is hypothyroidism, where the thyroid gland does not produce enough thyroid hormone, causing symptoms such as extreme fatigue, depression, weight gain, and forgetfulness.

Patients with hypothyroidism need medicine that will supplement the body with sufficient thyroid hormone. The human body produces five different thyroid hormones. There are two main treatment options: 1) FDA-approved hormones that are synthetic and only contain one of the hormones, either T3 or T4, and 2) NDT, made from the thyroid gland of pigs, which contains T1, T2, T3, T4, and calcitonin. Note that, to be of any help, T4 must be converted to T3, and many of us cannot do this efficiently.

Mainstream medicine preaches that it is sufficient to supplement only with T4; that the body will convert an appropriate amount of T4 into T3; and that T1, T2 and calcitonin aren’t needed. While this may be true for some hypothyroid patients, there are many others who get better only when they take NDT.

Compounded versions of NDT are crucial because pharmacies can individualize doses and delivery systems to meet individual patient needs. When thyroid glands are not functioning properly, they rarely stop producing hormones completely—they are producing the wrong levels of hormones. Doctors must determine how to correct these imbalances based on observed hormone levels in each patient. Additionally, hormone levels can fluctuate. This is why the one-size-fits-all FDA-approved options are not sufficient for many patients.

Note that compounded sustained-release T3 medications appear to be safe (for now) because they are made from a synthetic version of T3, not the natural version which is now considered a biologic and effectively banned from compounding.

Armour and other commercially available NDT products that are not compounded also appear safe for the time being, but that could change. Note that Armour and other brands of NDT are considered “grandfathered”; that is, they were in use before drugs were required to prove safety and efficacy and are allowed to remain on the market without adhering to those requirements as long as they are labeled with the same conditions for use. But the FDA has an “Unapproved Drug Initiative” to try to get these grandfathered drugs to go through FDA approval. In 2021, the FDA released a “Consumer Update” on thyroid medications, essentially warning patients from taking natural thyroid because these products have not been reviewed by the agency for safety and efficacy. Clearly, these medicines are on the FDA’s radar, and it wouldn’t be surprising to see the agency move against Armour and other commercially available NDT products in the future.

Some patients get Armour and other products from compounding pharmacies because they are more readily available than at chains like CVS or Walgreens. This should not be interrupted for the time being. Armour and other commercially available NDT products are still legal; the threat is to compounded NDT products.

Compounding allows doctors to custom-fit thyroid medications based on what you need as an individual, whether it’s a specific dose not found in FDA-approved drugs, or a time-released version, different combinations of T3 and T4, etc. It’s hardly surprising, then, that studies have found many, many patients prefer natural thyroid to synthetic options.

In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either:

  1. appear on an FDA pre-approved list (the Bulk Drug list);
  2. have a USP monograph; or
  3. be a component of an approved drug.

NDT has a USP monograph. So, what’s the problem? The FDA is now claiming that NDT meets the definition of a “biologic” (medications that come from living sources, like vaccines, monoclonal antibodies, etc.) because it contains thyroglobulin, an amino acid found in the pig glands used to make NDT. Biologics are not able to be compounded unless there is an approved biological license application (BLA), which is akin to a new drug application requiring clinical trials. The FDA is using a back-door method to ban medicines it has attacked for years.

This is, of course, absurd. Clinical trials cannot be conducted on compounded medicines given the highly varied and individualized doses and delivery mechanisms used. As explained above, this is the whole point behind compounded medicine, to customize medicines to meet individual patients’ needs. With this move, the FDA is in effect banning compounded NDT. What remains to be seen is how swiftly the agency will move to enforce this position.

We will return to this in subsequent coverage, but this is part of a years-long FDA campaign against natural thyroid. This stems from the fact that natural thyroid competes with Big Pharma’s FDA-approved T4 thyroid drugs, which include Levothyroxine and Synthroid. The market size of Levothyroxine alone is $2.3 billion, expected to grow to $3.5 billion by 2027. In a list of the top 300 most prescribed drugs of 2020, Levothyroxine was listed at number two with over 20 million patients and just under 99 million prescriptions. For many years, Synthroid was the top prescribed medicine in the US. Natural thyroid, and the compounding pharmacies that produce it, therefore represent an annoyance to the government-sponsored monopolists running Big Pharma.

As we’ve seen with the FDA’s campaign against other compounded bioidentical hormones, the agency also has an innate distrust of anything not FDA-approved. The FDA claims that these medicines, having not gone through FDA approval, cannot be guaranteed to be safe or effective, nor can hormone levels be guaranteed from batch to batch. We believe this is all a smoke screen. Natural thyroid has been compounded for years without any apparent safety issues. The FDA simply doesn’t like that it doesn’t have authority over natural thyroid and that there is significant competition for Big Pharma’s synthetic drugs.

The Alliance for Pharmacy Compounding, a trade group for compounding pharmacists, is holding a town hall event on this issue on October 13, 2022. Pharmacists and consumers interested in learning more are welcome to attend.

This is also concerning given the separate process by which the FDA is deciding whether bioidentical estriol, progesterone, and estradiol can continue to be compounded. This action is further proof that the FDA wants to see these hormones disappear. We can’t let that happen.

In the big picture, this is a direct threat to the very future of traditional compounding pharmacies. If they can’t make thyroid medications, or estriol, or estradiol, or progesterone, or curcumin, or many of the other natural medicines the FDA is attempting to ban from compounding, these pharmacies will go out of business. By all accounts, this appears to be the FDA’s goal. Time and time again in the agency’s communications on compounding, the FDA bemoans the lack of clinical trials that would attest to the safety and efficacy of compounded medicines—the standard used to approve new drugs. But legally compounded drugs are exempted from new drug approval requirements. What the agency is really saying is that it does not want compounded drugs to exist, period, because the agency doesn’t control them and they compete with Big Pharma’s drugs. We cannot let the FDA wipe out traditional compounding pharmacies.

Action Alert! Write to Congress and the FDA, telling them to retain consumer access to compounded natural thyroid medications. Please send your message immediately.

Go to top link to act against this government tyranny and overreach.

FDA Corruption:

FDA’s long history of coming against anything it considers competition:

Category:

Activism, Supplements

Comments Off on FDA At It Again – Attacking Natural Thyroid

Chronic Lyme Disease & Insurance: Why Patients Can’t Get the Care They Need

https://www.lymedisease.org/chronic-lyme-disease-insurance/

Chronic Lyme Disease and Insurance: Why Patients Can’t Get the Care They Need

By Lyme Policy Wonk

Previous studies have shown that patients who have persistent or chronic Lyme disease (PLD/ CLD) have a hard time obtaining the medical care they need to get well (Johnson 2011). A new study has found that clinicians who treat this population face significant challenges in providing patients care that is local, timely, and affordable (Johnson 2022).

Between September 23 and December 1, 2021, LymeDisease.org conducted a survey of U.S. clinicians who treat PLD/CLD patients. One hundred and fifty-five clinicians from 30 states responded to the survey and 45 provided comments in the open text survey item. The results of this survey were published this week: Access to Care in Lyme Disease: Clinician Barriers to Providing Care. The primary goal of this survey was to identify the difficulties that clinicians face when caring for patients with PLD/CLD.

The CDC estimates that 476,000 cases of Lyme disease occur annually (Kugeler 2021). Even when diagnosed and treated early, up to 44% of patients fail treatment, with only 56% considered to have returned to health (Aucott 2022). In later disease, treatment failure rates are higher. Lyme disease patients who remain ill after antibiotic treatment are regarded as having persistent or chronic Lyme disease. These patients may have been diagnosed early or late.

Chronic Lyme disease definition

Clinicians who treat PLD/CLD

Clinicians treating patients with PLD/CLD have developed significant clinical expertise. Most clinicians (55%) are  medical doctors (MD) or doctors of osteopathy (DO); the remainder are naturopaths with prescription privileges (15%), nurse practitioners (12%) or physician assistants (6%).

Over half of the clinicians (56%) have treated more than 500 patients and 38% have treated more than 1000 patients. Most (57%) dedicate more than half of their practice treating Lyme disease. Almost all (98%) have taken continued medical education for Lyme disease treatment. Eighty-nine percent belong to the International Lyme and Associated Diseases Society (ILADS) and most belong to other medical societies as well.

How many patients have you treated with Lyme disease?

Why Clinicians Who Treat Chronic Lyme Disease Find it Difficult to Provide Care

Despite their considerable expertise, clinicians report that providing care to PLD/CLD patients is challenging. In particular, the complexity of the care provided and the time it takes to provide that care make it difficult for clinicians to provide care using the traditional insurance-based healthcare model. This increases the cost of care provided to patients and makes it difficult for patients to pay for the care that can be given.

Why treating Lyme disease is hard

The complexity of care needed requires longer clinician visits than treatment for other conditions. For example, 25% of clinicians said their first consultations took more than two hours, and 44% said their follow-up visits took between one and two hours.

Clinicians reported that the length of healthcare visits for PLD/CLD coupled with the additional insurance administrative burdens and reimbursement payment issues make it hard for care to be given under a traditional insurance-based model, which typically relies on clinicians seeing a high volume of patients for short office visits. As one clinician explained:

“The most difficult problem is the cost of providing this amount of complex care on a cash basis. To really review hundreds of records, spend time with the patient and do a proper workup, takes hours. I’d like to see more support for patients and clinicians who choose to help this set of patients.”

As a result of these challenges, most PLD/CLD providers do not accept insurance:

  • 74% do not participate in insurance networks
  • 76% do not directly bill insurers
  • 77% do not participate in Medicare, Medicaid, or other government supported plans

Another reason the insurance model of providing care does not work for PLD/CLD is that the risk of legal or regulatory action by medical boards, insurance companies, and other organizations is heightened for clinicians who accept insurance. Three-quarters of the clinicians who answered the survey say that they have been professionally stigmatized. More than a third (39%) report that they have been threatened with actions by medical boards, insurance companies, or hospital quality improvement committees.

One clinician commented:

“While my patients are generally very supportive, some of my colleagues have stopped speaking to me and I worry about the medico-legal repercussions of what I do.”

39 percent reported to medical board

Another said:

“I used to practice in a state where physicians who treat complex patients, including people with chronic Lyme, were specifically targeted by health insurance companies for medical board complaints and other attacks ESPECIALLY WHEN THEY HELPED PATIENTS OTHER DOCTORS GAVE UP ON. Eventually I elected to move to [a state] where there is less interruption of care and more protection of vulnerable patients from predatory insurance entities.”

One way clinicians can avoid targeting by insurance companies and other groups is by opting out of insurance networks, Medicare, and Medicaid. Clinicians who are stigmatized or don’t participate in insurance networks have fewer chances to share office space and overhead costs. This increases the cost of providing care. Treating PLD/CLD also imposed additional insurance related burdens that increase the cost of providing care exist even for clinicians who do not participate in insurance networks. These include prior authorization of medications (77%), insurance denials (71%), and other insurance-related problems (49%).

When clinicians do not participate in insurance networks, the economic burden of shouldering the cost of care is shifted to patients. This makes care more expensive for patients who have to pay for care out-of-pocket. It doesn’t come as a surprise then that 75% of clinicians say that a central problem in their practice is the patients’ inability to pay out of pocket costs. One clinician commented:

“I knew that at some point I would be forced to stop taking insurance and move forward on a cash pay only basis. Looking at the numbers, taking commercial insurance for these patients just doesn’t make any sense. I believe that the main issue that causes many of these patients to be without access to care is the amount they need to spend on their practitioners plus the out of pocket costs for out of network testing, labs, and treatment. For most of these patients that is anywhere from $10 to $20K per year. It is a huge burden.”

Essentially, the insurance model of providing healthcare is broken for patients with PLD/CLD. Not only does this increase the costs of providing care for providers and shift the cost burden to patients, it also means that patients can’t get care from their regular provider, must obtain care from places that don’t take their insurance, and need to navigate a complex healthcare maze to even find the care they need. Patient surveys published previously also identify the high cost of out-of-pocket care (Johnson 2011).

In addition, previous surveys have found that patients incur substantial diagnostic delays, misdiagnosis, see many clinicians before being diagnosed, and travel significant distances to receive care (Johnson 2011, 2014, 2020). To obtain care, 49% of patients report traveling more than 50 miles; 31% report traveling 100 miles or more for care (Johnson 2011). Because obtaining care can be expensive, inconvenient, and interfere with work responsibilities, many patients may choose not to get care at all (Johnson 2022).

Clinicians here reported that patients with PLD/CLD often had to wait a long time for their first appointments, and that many of their patients traveled from outside their state of practice to obtain care. These factors point to a supply/demand crisis in the treatment of PLD/CLD. There are simply not enough clinicians to supply the amount of care required by patients to get well. The challenges identified by clinicians here—a broken insurance model of care, professional stigma, and heightened liability exposure—also discourage other clinicians from providing care to people with PLD/CLD.

Not enough Lyme disease clinicians

Why Early Diagnosis and Avoiding Misdiagnosis is Important

To address the supply/demand crises, it is important to reduce the number of patients who develop PLD/CLD. This requires early diagnosis and treatment. Clinicians identified inadequate physician education about tick borne diseases, false negative lab tests, and misdiagnosis as key causes of delayed diagnosis.

Delayed Lyme disease diagnosis

Nearly three quarters of patients report having initially been misdiagnosed. Misdiagnosis is often caused by the lack of education of other clinicians about tick-borne diseases (Johnson 2011, 2018). In a case series of people who might have had early Lyme disease but didn’t have a rash, 54% of Lyme disease patients who didn’t have a rash were given the wrong diagnosis (Aucott 2009). Because of this, misdiagnosis should be seen as a major risk factor for PLD/CLD.

Conclusion

The challenges identified here related to insurance and professional stigma make it hard to keep and hire clinicians who can care for the rapidly growing number of people with PLD/CLD, which is currently estimated to be slightly less than 2 million cases (Delong 2019). They also make care more costly for patients. Diagnostic delays and misdiagnosis increase the number of patients who develop PLD/CLD, exacerbating the supply/demand problem.

As Lyme disease cases rise, the demand for PLD/CLD providers will rise. The limited number of educated practitioners and the expanding number of PLD/CLD patients have created a substantial supply and demand imbalance that must be addressed.

Resolving the supply/demand imbalance is vital for PLD/CLD patients to become healthy. To do this we must:

  • improve clinician education to prevent diagnostic delay and misdiagnosis
  • retain and recruit more clinicians to address the supply demand crises by reducing professional stigma and recognizing that divergent treatment approaches exist in PLD/CLD
  • develop insurance reimbursement models that take into account the complexity of care and the time it takes to provide care.

Failing to address these issues will leave patients unable to access or afford the care that they need.

If you are a patient who is not enrolled in MyLymeData,  please enroll today. If you are a researcher who wants to collaborate with us, please contact me directly.

The MyLymeData Viz Blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org. You can contact her at lbjohnson@lymedisease.org. On Twitter, follow her @lymepolicywonk. 

Category:

Lyme, research

Comments Off on Chronic Lyme Disease & Insurance: Why Patients Can’t Get the Care They Need

Misdiagnosed For 30 Years – Had Lyme Disease

https://www.lymedisease.org/some-thoughts-about-30-years-of-misdiagnosed-lyme-disease/

Some thoughts about 30 years of misdiagnosed Lyme disease

Sept. 29, 2022

Kat Garza is what’s known in the industry as a “mature model”–pretty much any model over the age of 30.

One look at her photos easily demonstrates that women with gray hair can still be beautiful. But you have to dig a little deeper to find the life experiences that helped shape who she is.

Among other challenges, she suffered from unrecognized Lyme disease for three decades.

She also raised seven children, got divorced in her early 60s, and three years ago, at age 64, began her career as a model and Instagram “influencer.”

Here’s something she posted on Instagram the other day:

by Kat Garza

Can we talk about Lyme disease?

“But you look so healthy,” they say.

I was chatting with with my son today and he asked how I was doing. I had to answer that today – Lyme disease was kicking my butt.

Many days I feel just fine. Some days, not so good. But almost all days, I have to push myself and I do push.

Just last week I read an article about a 22 year old women who ended her life because she could no longer deal with the pain associated with Lyme disease. It hurts my heart to think that someone so young was in so much pain – a pain that was not taken seriously.

I know far too many others with Lyme disease who are not being listened to. They are not taken seriously and pushed aside with a misdiagnosis. I know I was. I was told:

• get tested for MS

• it’s your gallbladder

• it’s your heart

• it’s fibromyalgia

• it’s your diet

• it’s in your head

• it’s stress

• it’s lupus

#adnauseam tests after tests.

I was bitten by ticks 30 years ago and misdiagnosed, over and over and over again. I even had a massive brain tumor 23 years ago ago – something, I’m finding, that many with Lyme disease have also experienced. After multiple scans and tests almost three years ago, I finally found a doctor who listened and discovered it.

Why is it so difficult for a doctor to find it? Because they aren’t looking. If Lyme disease isn’t dealt with early on, it will attack the major organs of the body.

We are not told to see a doctor immediately when bitten by a tick. I have had people literally roll their eyes at me. It’s time for those ‘in the know,’ those in power, to take us seriously and listen to our plight, and believe us.

Do we need to march on Washington? Our congressional representatives aren’t listening. Certainly doctors aren’t listening. This disease needs to be brought to the forefront now. Maybe Amélie Champagne, age 22, would still be with us. If only someone would have listened.

You can follow Kat Garza here on Instagram.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, Board President of LymeDisease.org. She is co-author of When Your Child Has Lyme Disease: A Parent’s Survival Guide. Contact her at dleland@lymedisease.org.

Category:

Activism, Lyme

Comments Off on Misdiagnosed For 30 Years – Had Lyme Disease

Former EcoHealth Alliance VP Says Fauci-Funded Group ‘Developed’ COVID-19

October 5, 2022

http://  Approx. 44 Min

Sept. 23, 2022

“Everyone needs to know the truth” ~ Former EcoHealth Alliance VP turned whistleblower

Dr Andrew G. Huff, former EcoHealth Alliance VP turned whistle-blower spoke exclusively to Trial Site News about his tenure at the controversial organization, which has been at the centre of the Covid-origin lab leak theory. Huff, who is an expert in the field of bioterrorism and biosurveillance worked at EcoHealth Alliance from 2014-2016. He reviewed the research proposal “Understanding the risk of Bat Coronavirus Emergence” that was submitted to the NIH which detailed gain of function virology work, which he attests led to the creation of SARS-CoV-2. He warned Dr Peter Daszak, his former boss, about the biosafety and biosecurity risks but Daszak was dismissive of his concerns. Huff also revealed the fact there was no biological security officer and institutional biosafety committee at EcoHealth Alliance, which was a violation of NIH guidelines.

https://sharylattkisson.com/2022/09/former-ecohealth-alliance-vp-says-fauci-funded-group-developed-covid-19

Former EcoHealth Alliance VP says Fauci-funded group ‘developed’ Covid-19

by

The following is an excerpt from Just the News.

A former vice president for the EcoHealth Alliance, a major funder of the Wuhan Institute of Virology, claims that his organization “developed” SARS-CoV-2 through gain-of-function research that makes viruses more dangerous.

“The process of developing SARS-CoV-2 was also described in detail in the proposal submitted to, and ultimately funded by, the National Institutes of Health (HHS NIH), The National Institute of Allergy and Infectious Diseases (NIAID), by EcoHealth Alliance with the WIV and [University of North Carolina] listed as collaborators,” according to the sworn declaration of Andrew Huff, who is represented by the attorney Thomas Renz.

The statement is included in a much larger packet dated Sept. 12 posted by Renz, who represents clients challenging Covid-19 mandates, apparently directed to Wisconsin GOP Sen. Ron Johnson, whose name is in the file name.

“Anthony Fauci funded the creation of SARS-COV2 and lied to Congress about funding Gain-of-Function work,” Renz wrote in the summary – a claim also recently made by former CDC Director Robert Redfield.

Huff, a former U.S. Army infantryman in Iraq and former research fellow in the Department of Homeland Security, shared the full packet on Twitter, saying it was “sent to the US Senate and Congress last week.”

Read more here.

For more:

Category:

Activism, Viruses

Comments Off on Former EcoHealth Alliance VP Says Fauci-Funded Group ‘Developed’ COVID-19

Army Whistleblower: DOD, FDA, Violate Federal Code & Falsify Vaccine Injury Records

https://rumble.com/v1lbl6l-army-ltcol-theresa-long-md-full-testimony.html  Video Here (Approx. 32 min)

Army LtCol Theresa Long MD – Full Testimony 09/17/22

Exclusive testimony of Army Whistleblower LtCol Theresa Long MD (flight surgeon). Her testimony shows how the DOD, FDA and many other organizations are violating federal code and how the jabs are causing vaccine injuries to fighter pilots as well as their medical records are being falsified to cover up jab injuries. Injuries from brain tumors, cancer, and deadly heart conditions she shows how the jabs are injuring and grounding many young military pilots. Find out the dangers they are facing.

LtCol Theresa Long MD gave her “Whistleblower” testimony to the Alaska Medical Freedom Symposium in Palmer, Alaska. Hundreds were in in attendance with many more watching live online across the state and throughout the U.S and Canada.

Army LtCol Theresa Long MD give her heartfelt testimony just days after the passing of her Father.

For more:

Category:

Activism, vaccines, Viruses

Comments Off on Army Whistleblower: DOD, FDA, Violate Federal Code & Falsify Vaccine Injury Records