Is Disulfiram the Magic Bullet For Chronic Lyme Disease?

July 26, 2019

https://www.treatlyme.net/guide/antabuse-disulfiram-chronic-lyme-disease-treatment

Disulfiram_3D_ball

Disulfiram: Wikipedia

Please see above link for the following:

Marty Ross MD on Antabuse for Chronic Lyme Disease

This is mainly a video article. You will need to listen to the whole video for my thoughts on Antabuse (disulfiram) as a new treatment for chronic Lyme disease. Below this video I provide additional points I did not mention during Conversations with Marty Ross MD on 7/18/19 when I recorded these comments.

For more: https://madisonarealymesupportgroup.com/2019/06/03/disulfiram-in-the-treatment-of-lyme-babesiosis-3-case-reports/

https://madisonarealymesupportgroup.com/2019/07/14/disulfiram-breakthrough-drug-for-lyme-other-tick-borne-diseases/

 

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FDA Approves Generic Versions of Lyrica

https://www.workerscompensation.com/news_read.php?id=33193

FDA Approves Generic Versions of Lyrica

07/25/19

Leah King

On Monday, the FDA issued a press release announcing the approval of generic versions of the drug Lyrica (pregabalin). Those of us operating in the workers compensation industry are all too familiar with Lyrica. It’s a high-priced medication utilized for the treatment of pain related to nerve damage, and its inclusion within Workers’ Compensation Medicare Set-Asides (WCMSAs) has become more common and problematic in recent years. You may recall that last October, we published a detailed blog article on the inclusion of Lyrica within WCMSAs submitted to CMS for approval. However, our concerns mounted when CMS’ published its most recent WCMSA reference guide in January, 2019, which specifically noted Lyrica as an example in the WCMSA Reference guide for off-label medication inclusion, as

Example 1: Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. Lyrica is considered acceptable for pricing as a treatment for WCMSAs that include diagnoses related to radiculopathy because radiculopathy is a type of neuropathy related to peripheral nerve impingement caused by injury to the supporting structures of the spinal cord.

Lyrica was initially approved by the FDA in December of 2004 for a single indication of neuropathic pain associated with diabetic peripheral neuropathy. Lyrica was developed by Pfizer, a large pharmaceutical manufacturing company. Over the course of the next fourteen years, Pfizer was successful in securing FDA approval for additional indications including fibromyalgia, neuropathic pain associated with spinal cord injury, post-herpetic neuralgia and adjunctive therapy for adult patients with partial onset seizures. In addition, Lyrica has seemed to gain medical acceptance for the treatment of low back pain and radiculopathy in an off-label capacity, hence the inclusion of this medication in many CMS approved WCMSAs, as we mentioned in our earlier blogs. Pfizer’s patent protection for Lyrica was scheduled to expire in December of 2018. However, in November of 2018, Pfizer secured a six-month patent extension for a new pediatric indication of Lyrica. At that time, there was a collective sigh of disappointment, because news of the patent extension meant that a generic version of Lyrica would be delayed.

In Monday’s press release, the FDA announced that it had approved generic drug applications for pregabalin submitted by eight manufacturers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals and Teva Pharmaceuticals. The multitude of manufacturers who are entering the market at this early stage could have significant implications for the price of pregabalin in the coming months. A common regulatory scenario for generic drugs is that the first generic manufacturer to secure FDA approval of a generic drug application will receive a 180-day period of marketing exclusivity. During this 180-day period of exclusivity, other generic manufacturers are precluded from entering the market. The potential for six months of exclusive generic drug marketing was incorporated into the Hatch-Waxman Amendments in 1984 with the best of intentions. The exclusivity period was established to stimulate the development of generic medications in an effort to lower drug costs. In more recent years, however, the award of exclusivity to a generic manufacturer has come under fire because exclusivity can have the unintended result of delaying the entrance of the generic product into the market. Generic manufacturers sometimes enter into reverse payment arrangements with the brand name manufacturer, whereby the generic manufacturer accepts payment from the brand name manufacturer in exchange for an agreement to delay the production of the generic product for a certain length of time. In the pharmaceutical industry, these agreements are known as “pay-to-delay” or “pay-for-delay” arrangements.

In the case of pregabalin, the FDA did not grant a period of generic exclusivity to a single manufacturer. This will likely produce favorable market conditions over the next few months, as these eight manufacturers will begin to distribute the generic pregabalin products. With several manufacturers entering the market sooner rather than later, the increased competition for market share will likely result in price decreases over the course of the next several months. Of course, we’ll continue to monitor the average wholesale price (AWP) of pregabalin products and post noteworthy developments here on our blog. Pregabalin will be available in generic formulations of all commercially available formulations of Lyrica: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules. It will also be available as a 20mg per ml oral solution.

By Leah King

Courtesy of MedVal

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Recent Discoveries & Advancements in Research on the Lyme Disease Spirochete Borrelia Burgdorferi

July 25, 2019

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545822/

Version 1. . 2019; 8: F1000 Faculty Rev-763.
Published online 2019 May 31. doi: 10.12688/f1000research.18379.1
PMCID: PMC6545822
PMID: 31214329

Recent discoveries and advancements in research on the Lyme disease spirochete Borrelia burgdorferi

Christa Winslow, Writing – Original Draft Preparation1 and Jenifer Coburn, Writing – Review & Editinga,1,2

Abstract

This review highlights some of the highest-profile developments and advancements in the research on Borrelia burgdorferi, the Lyme disease spirochete, that have emerged in the last two years. Particular emphasis is placed on the controversy surrounding genus nomenclature, antigenic variation at the vlsE locus, genes involved in infectivity and virulence, membrane characteristics of B. burgdorferi, and developments in experimental approaches.

__________________

**Comment**

Research hailing from Milwaukee, WI.

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Lyme, research

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Oppose Wisconsin Rule Change to Mandate Meningitis Vaccines & Require Documentation of Chicken Pox Infection

image001

OPPOSE Wisconsin Rule Change to Mandate Meningitis Vaccines and Require Documentation Of Chicken Pox Infection

Submit Comments before 5:00 p.m. Friday 7/26/2019

Attend or Call in to Hearing on Friday7/26 from 8:30-9:30 a.m.

Dear Wisconsin NVIC Advocacy Team Members,

This is a critical action alert for Wisconsin families who care about vaccine choice.

The Wisconsin Department of Health Services is seeking to use the rule making process to increase vaccine mandates for students. This is different from a bill that passes through the legislature, though adopted rules have the same force as law.

If these regulations pass, 7th graders will be required to get a meningitis vaccine and parents will no longer be allowed to confirm that their children had chicken pox, requiring medical personnel to verify it.  These rules are another step toward taking away parental choice in medical decisions for their family and YOUR input is necessary to stop additional government overreach.

The most important way to stop these changes is to SUBMIT PUBLIC COMMENTS OPPOSING the proposed rule change by 5:00 pm on Friday, JULY 26.  It is critical that large numbers of opposition comments are received to stop this rule from passing.

ACTION TO TAKE:

  1. Submit public comments before 5:00 p.m. on Friday 7/26! Talking points below.

Use  web-site form: Select DHS 144 from “Rulemaking Projects” box.

OR

Written comments can be mailed (postmarked by 7/26) or e-mailed by 5:00 p.m. on 7/26:

Susan Uttech

Division of Public Health

Department of Health Services

1 W. Wilson St.

Madison, WI 53703

Email: susan.Uttech@dhs.wisconsin.gov

  1. Attend the public hearing in Madison on 7/26 – testify to oppose the changes.

            Friday, July 26th at 8:30 am-9:30 am.

Conference Room 751

1 Wilson Street

Madison WI  53703 Map 

  1. Call into the hearing to give public comment. Call (608) 316-9000 and use Conference ID: 7313694
  2. Send a copy of this email to your friends and encourage or assist them in writing and submitting public comments.
  3. Please send a copy of your comments to your own state legislators in the house and senate asking them to oppose these rules if they make it to the legislature for approval.  Your legislators can be found HERE:  Enter your address in the web-form.
  4. Continue monitoring the NVIC Advocacy Portal NVICAdvocacy.org to track the status of these rules or other legislation. From here, the Rules will later go before both the House & SenateHealth and Human Services Committees for approval or rejection.  Please save copies of your comments submitted to the department so you can send a copy of your comments to these committee members, with a request that they STOP these Rules when/if they are presented if the health department does not withdraw them.  

DESCRIPTION OF PROPOSED RULES & REASONS TO OPPOSE THEM

  • Proposed changes to Immunization Requirements: HERE.
  • Analysis of the rule and the additional documents: HERE
  • The most recent version of the proposed rule text: HERE.   DHS 144
  • The fiscal estimate and economic impact analysis: HERE.
  • The public hearing notice can be found HERE.

There are several proposed rule changes.  1, 2, 4 and 5 cause the most concern, with 4 and 5 being the most concerning.

1) The Department proposes to change the “substantial outbreak” classification of chicken pox and meningitis.

2) The Department proposes to change the “substantial outbreak” classification of mumps due to mumps outbreaks in “highly-vaccinated populations.”

4) Meningitis vaccine is mandated for 7th grade students.

5) Parents are no longer able to provide confirmation of their children’s case of chicken pox/varicella, requiring a health care provider to now confirm it.

TALKING POINTS:  These are listed in order of importance.  Please use your own words to state your opposition to the proposed changes and include any personal stories that support your concerns.

OPPOSE Proposed Change 4. Meningitis vaccine requirement for 7th graders.

  • There is no urgent public health crisis to justify the expensive and potentially dangerous meningitis vaccine mandate for all Wisconsin 7th graders.
  • Meningitis is very rare in the United States, with the CDC reporting a total of only 350 cases in 2017.  The 2017 US population of approximately  325.7 million, meant that 1 in 931,000 people got meningitis and 1 in 7.2 million died.  Of the 45 deaths, ONLY 14 cases were in the age group 0-23.  These numbers do NOT indicate a public health crisis.  The mandate is unnecessary.
  • Meningococcal vaccine is currently available to any family who wants it.
  • According to the CDC, Wisconsin recorded only 6 meningococcal cases in 2016 and 4 cases in 2017. The state records are slightly different, yet, in 2015, there were only 3 cases in the 14-23 age group, with one of those being in college or technical school.
  • The vaccine only has an 80-85% efficacy rate. After two years to five years, the vaccine has been found to be, at best, only about 58 percent effective. Due to the  vaccine’s effectiveness waning, the only recommendation is that ADDITIONAL vaccines be given.
  • The package inserts for meningitis vaccines, Menactra and Menveo, indicate that   “serious adverse events” occur in 1 percent of recipients.
  • According to the CDC Pink Book, 0.3 percent of those with “serious adverse events” from meningitis vaccines will die.
  • If approximately 63,000 7th graders are given the Menactra or Menveo meningitis vaccines, Wisconsin can reasonably expect 630 serious adverse events and possibly 2 (1.89) deaths.
  • This is significant since the 2015 Wisconsin data only shows 2 cases of meningitis in high school age students with NO deaths.
  • The federal Vaccine Adverse Events Reporting System (VAERS), which includes only a small fraction of the health problems that occur after vaccination in the U.S., reports 32,453 adverse events as of July 2019.  Of these, 3,955 were considered serious and there were 186 deaths, with 90 of those being in children under 17 years of age. www.medalerts.org
  • The meningitis vaccines contain neurotoxins such as formaldehyde, aluminum hydroxide, polysorbate 80, and thimerosal, a mercury derivative.
  • Meningitis vaccines list documented side effects including death, anaphylaxis/anaphylactic reaction, difficulty breathing, upper airway swelling, Guillain-Barré syndrome, dizziness, convulsion, acute disseminated encephalomyelitis, irritability, abnormal crying, fever, drowsiness, fatigue, injection site pain and swelling, sudden loss of consciousness (syncope), diarrhea, headache, joint pain, brain inflammation, and facial palsy.   Bexsero,  Menveo,Menomune, Menactra

OPPOSE Proposed Change 5. Parental reporting of chicken pox will no longer be acceptable.  Instead, a health care provider must confirm infection.

  • It is irresponsible of the Department to insist that a child with a highly contagious, yet often a generally mild disease, visit a medical facility where other children, including those who are medically fragile, will likely be present and thus at higher risk to contract it and become one of the rare adverse outcomes.
  • Not all families have existing relationships with the list of specified medical workers, and this provision could force a family to enter into a new unwanted contractual relationship with unknown medical staff.
  • Most families will also have the financial burden of all charges, or co-pays as well as laboratory fees.
  • This change would create an environment of distrust between the school staff and the parents as the parents’ word is questioned.
  • There is no provision for a titer test to be used as proof.

The Department’s claims of “little to no economic impact” in their justification for the rule change doesn’t reflect the strong negative economic impact on Wisconsin Families

  • Wisconsin families will be required to pay for doctor visits and vaccine costs to receive newly mandated vaccines.
  • The annual cost for approximately 63,000 Wisconsin 7th graders to receive meningitis vaccines will be over $10.7 million as the CDC vaccine price list for Bexsero shows the private sector cost at $170/dose.  Add in office visit expenses and there is little doubt why there is significant support for this vaccine by those who gain financially for its mandated use.
  • Requiring Wisconsin families to pay for doctor visit to have chicken pox verified will be expensive.  For generations, many families have treated chicken pox at home, as it is generally mild.  Arranging an office visit for a case of the chicken pox would add drastically to the economic impact on the families of a sick child.

OPPOSE Proposed Change 2. Change the “substantial outbreak” classification of mumps

  • The mumps component of the MMR used in the US has been the subject of a federal whistleblower fraud suit since 2010.  Two manufacturer (Merck) virologists claimed they were forced to create fraudulent efficacy results by adding rabbit antibodies so that the vaccine could remain on the CDC schedule and Merck could retain its monopoly.
  • The reason for this change is due to mumps outbreaks in “highly-vaccinated populations,” showing the vaccine’s ineffectiveness.  A few years, 1676 Arkansas school age children had mumps and 1536 (92%) had previously received at least two doses of a vaccine containing the mumps virus.  A recent mumps outbreak amongst  100% vaccinated Navy sailors on the USS Ft. McHenry, kept it in quarantine for over 5 months.
  • The Health Department should educate families on the risks of catching mumps and how to treat it due to an ineffective vaccine.

OPPOSE Proposed Change 1. Change the “substantial outbreak” to include meningitis and chicken pox. OPPOSE the inclusion of chicken pox in the “substantial outbreak” classification due to it generally being a mild infection that can be treated at home.

OPPOSE Department’s lack of notifying the public, the MAIN STAKEHOLDER, when publishing these proposed rules changes.

  • The Department claims they contacted all stakeholders which would be impacted by the proposed rule including, “Schools, school-aged children and parents, school boards, and public and private health care providers.”
  • Parents were not included as stakeholders, neither were they adequately informed.  The Department’s effort to inform the primary stakeholder, parents of school age children, was completely inadequate.  If not for the attention by watch dog groups, this rule would be implemented without parents knowing of their ability to participate in the process to oppose it.
  • Using the Rule process to change vaccine mandates removes the process from legislators who are accountable to their voting constituents.

Sincerely,

NVIC Advocacy Team
National Vaccine Information Center
http://NVIC.org and http://NVICAdvocacy.org
https://nvicadvocacy.org/members/Members/ContactUs.aspx

The National Vaccine Information Center (NVIC) works diligently to prepare and disseminate our legislative advocacy action alerts and supporting materials.  We request that organizations and members of the public forward our alerts in their original form to assure consistent and accurate messaging and effective action. Please acknowledge NVIC as originators of this work when forwarding to members of the public and like-minded organizations. To receive alerts immediately, register  at http://NVICAdvocacy.org, a website dedicated to this sole purpose and provided as a free public service by NVIC. 

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Activism, vaccines

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Avoiding Direct Detection Methods For the Purpose of Concealing Chronic Lyme Disease Is A Crime

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/24842662?

Avoiding direct detection methods for the purpose of concealing chronic Lyme disease is a crime

JUL 19, 2019 — 

The letter below from Dr. Paul Auwaerter (Past president of the IDSA) is third in a series of correspondence over my request for proficiency testing for Nested PCR And DNA Sequencing For The Detection Of Lyme Disease And Related Borreliosis; the direct detection of the spirochete causing Lyme disease. Previous communication can be reviewed in recent Petition Updates.

The real reason the CDC stopped communication with Drs Lee and Shearer is because they published a case of chronic Lyme where a so-called Lyme disease specialist condemned a sixteen year old to a psychiatric ward because his Western blot only had 4 out of the 5 IgG bands required for positive test result. It is no secret that the US Centers for Disease Control is in bed with the IDSA.

Lyme Bumper Stickers (Public Service Announcement)
https://www.ebay.com/itm/123659578861

WAKE UP AMERICA!
Today’s letter to the Tick-borne Disease Working Group……

——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: tickbornedisease@hhs.gov, chris.smith@mail.house.gov
Cc:(98 Undisclosed recipients)
Date: July 19, 2019 at 9:16 AM
Subject: Re: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics

To the Tick-Borne Disease Working Group,

Please see the final response from Dr. Paul Auwaerter who is not interested in proficiency testing for direct detection of Lyme disease. My reply to Dr. Auwaerter immediately follows his note below:

Response from Dr. Paul Auwaerter:

——— Original Message ———-
From: Paul Auwaerter <pauwaert@jhmi.edu>
To: CARL TUTTLE <runagain@comcast.net>
Cc: psax@bwh.harvard.edu, jli@bwh.harvard.edu, cbusky@idsociety.org, Takaaki Kobayashi <tkobayashi@jhmi.edu>, jmstiglich@healio.com, infectiousdisease@healio.com
Date: July 18, 2019 at 9:23 PM
Subject: RE: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics

Dear Mr. Tuttle,

I’d like to close our correspondence to make clear the Foundation doesn’t have funds currently to entertain your specific area of research.  You may get a sense of the funding priorities of the IDSA Foundation from our website; however, if philanthropic funds are made available with disease-specific areas, the IDSAF would entertain such research funding.

I have read your other concerns with our paper and approach, and I do hear your disagreement.

Sincerely,

Paul Auwaerter MD

Vice-Chair, IDSA Foundation

__________________________________

Carl Tuttle’s reply to Dr. Auwaerter:

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: Paul Auwaerter <pauwaert@jhmi.edu>
Cc: psax@bwh.harvard.edu, jli@bwh.harvard.edu, cbusky@idsociety.org, Takaaki Kobayashi <tkobayashi@jhmi.edu>, jmstiglich@healio.com, infectiousdisease@healio.com
Date: July 19, 2019 at 8:58 AM
Subject: RE: Lyme disease often misdiagnosed, resulting in unnecessary antibiotics

Dear Dr. Auwaerter,

In conclusion of our correspondence I would like to offer the following publication:

DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139787/

Faulty/misleading antibody tests landed a sixteen year old male in a psychiatric ward when his lab results did not meet the CDC’s strict criteria for positive results. His Western blot had only four of the required five IgG bands. Subsequent DNA sequencing identified a spirochetemia in this patient’s blood so his psychiatric issues were a result of neurologic Lyme disease misdiagnosed by antiquated/misleading serology. This patient was previously treated with antibiotics.

Current antibody tests for Lyme disease cannot be used to gauge treatment failure or success which makes them the ideal tool for concealing persistent infection.

I want to make this perfectly clear Dr. Auwaerter; avoiding direct detection methods for the purpose of concealing chronic Lyme disease is a crime.

Sincerely,

Carl Tuttle

Lyme Endemic Hudson, NH

__________________

**Comment**

This unfortunate story of someone being admitted to the psych ward due to not testing “positive enough” is only one of thousands…

This has been going on for over 40 years all over the world.

I’ve posted this before, but it bears repeating:  https://madisonarealymesupportgroup.com/2017/07/09/idsa-founder-used-potent-iv-antibiotics-for-chronic-lyme/

“Setting arbitrary level of antibodies to diagnose a disease that has not been amenable to Koch’s postulates seems open to question.  By the same token, ignoring antibody results unless they meet arbitrary levels seems suspect.  The vast majority of patients in this series showed some WB antibody exposure, but many did not meet the arbitrary limits set….in our present state of knowledge, the diagnosis of chronic Lyme disease is a clinical one.  Many of the patients in this series have suffered serious ‘hurts’ when they have been told that they could not have LD because their WB did not meet arbitrary limits.”  Dr. Waisbren

Horrific antibody testing has been dooming patients for literally 4 decades. Time for change.

https://madisonarealymesupportgroup.com/2018/09/12/lyme-testing-problems-solutions/

https://madisonarealymesupportgroup.com/2018/01/16/2-tier-lyme-testing-missed-85-7-of-patients-milford-hospital/

 

Category:

Activism, Lyme, Testing

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