Archive for the ‘Uncategorized’ Category

Petition: 2017 Lyme Case Definition

First, the new 2017 Lyme Case Definition as defined by the CDC below, then the petition started by Carl Tuttle who rightly has an issue with the fact that the following is missing:

“This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis”

https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/

Lyme Disease (Borrelia burgdorferi)
2017 Case Definition
CSTE Position Statement(s)

16-ID-10
Clinical Description

A systemic, tick-borne disease with protean manifestations, including dermatologic, rheumatologic, neurologic, and cardiac abnormalities. The most common clinical marker for the disease is erythema migrans (EM), the initial skin lesion that occurs in 60%-80% of patients.

For purposes of surveillance, EM is defined as a skin lesion that typically begins as a red macule or papule and expands over a period of days to weeks to form a large round lesion, often with partial central clearing. A single primary lesion must reach greater than or equal to 5 cm in size across its largest diameter. Secondary lesions also may occur. Annular erythematous lesions occurring within several hours of a tick bite represent hypersensitivity reactions and do not qualify as EM. For most patients, the expanding EM lesion is accompanied by other acute symptoms, particularly fatigue, fever, headache, mildly stiff neck, arthralgia, or myalgia. These symptoms are typically intermittent. The diagnosis of EM must be made by a physician. Laboratory confirmation is recommended for persons with no known exposure.

For purposes of surveillance, late manifestations include any of the following when an alternate explanation is not found:

Musculoskeletal system . Recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints. Manifestations not considered as criteria for diagnosis include chronic progressive arthritis not preceded by brief attacks and chronic symmetrical polyarthritis. Additionally, arthralgia, myalgia, or fibromyalgia syndromes alone are not criteria for musculoskeletal involvement.
Nervous system . Any of the following signs that cannot be explained by any other etiology, alone or in combination: lymphocytic meningitis; cranial neuritis, particularly facial palsy (may be bilateral); radiculoneuropathy; or, rarely, encephalomyelitis. Headache, fatigue, paresthesia, or mildly stiff neck alone, are not criteria for neurologic involvement.
Cardiovascular system . Acute onset of high-grade (2nd-degree or 3rd-degree) atrioventricular conduction defects that resolve in days to weeks and are sometimes associated with myocarditis. Palpitations, bradycardia, bundle branch block, or myocarditis alone are not criteria for cardiovascular involvement.
Laboratory Criteria for Diagnosis

For the purposes of surveillance, laboratory evidence includes:

A positive culture for B. burgdorferi, OR
A positive two-tier test. (This is defined as a positive or equivocal enzyme immunoassay (EIA) or immunofluorescent assay (IFA) followed by a positive Immunoglobulin M1 (IgM) or Immunoglobulin G 2 (IgG) western immunoblot (WB) for Lyme disease) OR
A positive single-tier IgG2 WB test for Lyme disease3.
1 IgM WB is considered positive when at least two of the following three bands are present: 24 kilodalton (kDa) outer surface protein C (OspC)*, 39 kDa basic membrane protein A (BmpA), and 41 kDa (Fla). Disregard IgM results for specimens collected >30 days after symptom onset.

2 IgG WB is considered positive when at least five of the following 10 bands are present: 18 kDa, 24 kDa (OspC)*, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa flagellin (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa.

3 While a single IgG WB is adequate for surveillance purposes, a two-tier test is still recommended for patient diagnosis.

*Depending upon the assay, OspC could be indicated by a band of 21, 22, 23, 24 or 25 kDA.

Criteria to Distinguish a New Case from an Existing Case

Case not previously reported to public health authorities.

Exposure

Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) of Lyme disease vectors. Since infected ticks are not uniformly distributed, a detailed travel history to verify whether exposure occurred in a high or low incidence state is needed. An exposure in a high-incidence state is defined as exposure in a state with an average Lyme disease incidence of at least 10 confirmed cases/ 100,000 for the previous three reporting years. A low-incidence state is defined as a state with a disease incidence of <10 confirmed cases/100,000 (see https://www.cdc.gov/lyme/stats/tables.html). A history of tick bite is not required.

Case Classification

Suspected

A case of EM where there is no known exposure (as defined above) and no laboratory evidence of infection (as defined above), OR
A case with evidence of infection but no clinical information available (e.g., a laboratory report).
Probable

Any other case of physician-diagnosed Lyme disease that has laboratory evidence of infection (as defined above).

Confirmed

A case of EM with exposure in a high incidence state (as defined above), OR
A case of EM with laboratory evidence of infection and a known exposure in a low incidence state, OR
Any case with at least one late manifestation that has laboratory evidence of infection.
Case Classification Comments

Lyme disease reports will not be considered cases if the medical provider specifically states this is not a case of Lyme disease, or the only symptom listed is “tick bite” or “insect bite.”

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/19051457

Federal Public Law 107-116 passed by the Senate and House and signed by President Bush on January 10, 2002; Wording on that bill states that the CDC’s case surveillance definition is “misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases.” It also instructs the CDC to correct this misuse.

Please sign petition at the change.org site above.

 

Category:

Uncategorized

Lyme & Reason Up For Three Emmys

1st nomination for entire 22 minute special report.  2nd nomination for “Gone in a Heartbeat,” Dr. Spector’s story of how undiagnosed Lyme necessitated a heart transplant.  3rd nomination in the category of “Interactivity,” due to how Fox5NY impacted the entire country by these Lyme broadcasts.

Here they are again

Lyme & Reason:  The Cause & Consequence of Lyme Disease.  June 30,2016

Brian A. Fallon, MD, Steven Phillips, MD, Paul Mead, MD, singer and songwriter Dana Parish, Lyme patient and advocate Susan Green, oncologist Neil Spector, MD, actress and TV personality Marla Maples, author, artist and designer Ally Hilfiger, Patricia De La Mora, Associate Professor, Lawrence Putter, MD, and 12-year-old Julia Bruzzese all speak on MSIDS.

Lyme & Reason 2.0:  The Voices of Change.  Nov 18, 2016

Focuses on the use of social media as a tool to inform and open the door to change on the Lyme disease front, and how patients, advocates, physicians and others are moving the conversation forward. Plus, host Teresa Priolo sits down with TV personality and Lyme disease patient and advocate Yolanda Hadid about her ongoing battle with Lyme.

Category:

Activism, Lyme, Uncategorized

Lyme & Reason Interview with Lorraine Johnson

LymeDisease.org  CEO Lorraine Johnson’s extended “Lyme & Reason” interview
where she discusses the power of social media and technology to help change the national conversation about Lyme disease.

Only parts of her interview were included in Lyme & Reason 2.0. However, Fox5NY has generously made the uncut interview available to the public as well.

Published on Jul 1, 2016

“LYME AND REASON: THE CAUSE AND CONSEQUENCE OF LYME DISEASE” presents an in-depth look at the cause and effect of Lyme disease, including the controversy over testing, the issues of misdiagnosis, and the personal struggles of medical professionals and patients contending with this life-changing illness.

-Brian A. Fallon, MD, MPH, Director of the Center for Neuroinflammatory of the Lyme and Tick-Borne Diseases Research Center at Columbia University talks about the cause of Lyme disease and what you should do if you’re bitten by a tick!

-Yale-trained Lyme disease expert Steven Phillips, MD, addresses the controversy surrounding Lyme disease, while Paul Mead, MD, Chief of Epidemiology and Surveillance Activity of The Bacterial Diseases Branch of the Centers for Disease Control and Prevention, offers the perspective from the country’s lead public health agency.

-Singer and songwriter Dana Parish describes how Lyme disease temporarily derailed her music career during the prime of her life, and how she is now raising awareness about this debilitating illness!

-Lyme patient and advocate Susan Green of the non-profit The National Capital Lyme and Tick-Borne Disease Association (NatCapLyme) talks about the burden placed on families in terms of costs for the treatment of Lyme disease!

-Renowned oncologist Neil Spector, MD, shares his own personal story of his transition from doctor to patient, and how Lyme disease led to an emergency heart transplant!

-Actress and TV personality Marla Maples talks about her own diagnosis of Lyme disease, and how she is encouraging other celebrities to share their stories to put the spotlight on Lyme!

-Author, artist and designer Ally Hilfiger, the daughter of fashion icon Tommy Hilfiger, reflects on how Lyme disease stole her childhood, and her mind after being committed to a psychiatric hospital!

-Patricia De La Mora, Associate Professor of Clinical Pediatrics, Weill Cornell Medical College talks about prevention and how to keep your children safe, while Lawrence Putter, MD – Medical Director Lenox Hill Veterinarians discuss pet safety when it comes to ticks!

-12-year-old Julia Bruzzese shares her heartbreaking story of how Lyme disease has left her unable to walk, and how a blessing from Pope Francis on his visit to NYC last year has given her and her family hope for recovery!

Category:

Uncategorized

MiraLAX & Behavioral Issues in Children

http://abc7chicago.com/video/embed/?pid=1776754“>http://abc7chicago.com/video/embed/?pid=1776754

ABC 7 Eyewitness News Video News report

http://abc7chicago.com/news/update-more-families-speak-out-over-miralax-side-effects-for-kids/1777380/

By Wendy Saltzman

Tuesday, February 28, 2017 11:38AM
An Action News Investigation making national headlines has revealed parents’ concerns that a popular over the counter medication is sickening kids.

Following our report, we heard from families across the country who are also voicing claims that their children have developed neuro-psychiatric problems and other troubling side effects after taking MiraLAX.

Lots of parents have reached out to us asking what to do, desperate for answers, because some say after their children were prescribed MiraLAX off label, the behavioral issues started – from depression to anger, anxiety and mood swings.

Now, we have some answers from the experts, including new details on the Children’s Hospital of Philadelphia study, and resources where parents can turn.

“I didn’t feel like a normal kid,” Nicole Oerkfitz from North Wales, Pa. told Action News.

Oerkfitz was placed on MiraLAX when she was just 3-1/2 years old.

“I would be very aggressive towards my sister; I would want to kill my sister, and I was 4,” Oerkfitz said.

Her mother Jeanie Ward said she was horrified to see her once care-free daughter change drastically after she says she took MiraLAX for just ten days.

“Near psychiatric events with paranoia, mood swings, aggression, rage, the OCD repetitive chewing,” Ward said.

It was similar to the stories other families shared with Action News, after they say doctors prescribed MiraLAX off label to treat their children’s constipation.

“After six days on MiraLAX, we noticed overnight he acted out of character,” parent Sarah Locatelli said.

As Action News reported, MiraLAX is made up of Polyethylene Glycol or PEG 3350. The label says for use in “adults and children 17 years of age and older” and for “no more than 7 days.”

But our investigation found many doctors prescribe MiraLAX for young kids, and in some cases for long term use.

Now, doctors at CHOP are speaking out to Action News for the first time, defending the safety of MiraLAX.

“Since MiraLAX came out, we found it so effective, currently it is the go to medication to start with,” CHOP pediatric gastroenterologist Dr. Ritu Verma said.

Dr. Verma admits some of her own patients have claimed their children experienced concerning side effects from the medication, but she says there is no evidence as of yet that it causes any harm.

“We do not at this time have any information at all to say that this is an unsafe medication,” Verma said.

The FDA previously told Action News there was “insufficient data to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children” – citing only 167 adverse events reported to the FDA.

But we dug through a 3,900 page document of 14,688 adverse event reports through 2016 and found more than five times as many. The FDA’s own records actually document 950 children who have reported adverse events to the FDA after taking MiraLAX, ranging from mouth ulcers, to suicidal thoughts, mood swings, aggression and seizures.

The Administration confirmed these numbers, but says there are several limitations including that adverse event reports don’t necessarily prove a relationship between the product and the event. And said, “the FDA has considered these reports…and at this time does not believe additional warnings or other changes are warranted.”

“If a parent is extremely concerned about the side effects of MiraLAX or any other medication, they should stop the medicine,” Verma said.

Osteopathic pediatrician, Dr. Kristen Berry, says she’s anxious to see the results of CHOP’s study.

“We should not be using something off label that’s not approved in children. I definitely have a great concern over that,” Berry said.

CHOP wouldn’t talk about the $325,000 study they are conducting for the FDA, which was commissioned back in 2014.

But to our surprise, apparently it hasn’t started yet.

After our report, they published a statement online, which says, “Researchers…have not begun enrolling children, but once enrollment begins, an announcement will be made.”

“To me, there is definitely what I would call a red flag,” civil attorney Derek Braslow told Action News.

Braslow says he is now reviewing more than 500 families’ claims and is considering filing a lawsuit against Bayer, the maker of MiraLAX.

“The manufacturer has a duty to give an adequate and fair warning of what the benefits of the drug are, and what the risks of the drug are and if they are not doing that then they are liable,” Braslow said.

But for now, for the families we spoke with, questions still remain.

“The rage lasted about 13 years, like it just stopped,” Oerkfitz said.

Oerkfitz, now 19, says the side effects – anger, paranoia, and anxiety – have just recently subsided. And while her memories are filled with pain, she hopes other families will think twice before giving their children MiraLAX.

“I don’t feel like I got to live a normal childhood,” Oerkfitz said.

Bayer previously told Action News there have been many clinical studies conducted with PEG 3350 in pediatric populations which have demonstrated safety for short and long term use in children.

Link to CHOP study: http://heuckeroth.research.chop.edu/peg-3350-study

FDA Statement:

Response to your question on adverse events reported to the FDA:
It is important to note that over-the-counter products containing PEG 3350 are not labeled for use in pediatric patients (other than to direct parents to consult a doctor) or for extended periods of time. However, the agency has undertaken comprehensive reviews of adverse event reports and medical literature. These reviews have indicated that the approved labeling for PEG 3350 products accurately conveys their risks, and additional warnings regarding neuropsychiatric issues in children are not warranted at this time. However, we understand that many parents and physicians rely on these products to treat serious constipation. Because the FDA takes the health and welfare of pediatric populations very seriously, the agency is funding research at Children’s Hospital of Philadelphia (CHOP) to better determine the benefits and risks associated with the use of these products in children. The study is ongoing.

With respect to adverse events, the FDA confirms that, as found in the provided FOIA report which dates up to September 16, 2016, there are nearly 1,100 reports of adverse events in FAERS referencing MiraLAX and pediatric patients. However, it is important to understand that adverse event reports (FAERS data) do have limitations. First, there is no certainty that the reported event was actually due to the product. For a safety report, the FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to fully evaluate an event. Reports are often duplicates or updates of previously reported events, and therefore a raw count of reports may not accurately convey the number of unique events that have actually been reported to FDA. Further, the FDA does not receive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about a drug or event. Therefore, FAERS cannot be used to calculate the incidence of an adverse event in the U.S. population. In addition, while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product. Sometimes after further analysis, the adverse events may inform agency decisions to take regulatory action. Other times, further analysis shows that the adverse events were not attributable to a problem with the product but to other factors, such as a patient’s underlying health conditions. It also is important to note that the number of adverse events identified may fluctuate with our growing understanding of an issue, as well as through identification and elimination of duplicate reports.

For more information regarding FAERS: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm

As mentioned above, the FDA has considered these reports as part of its review and at this time does not believe additional warnings or other changes are warranted. We look forward to results of the CHOP study, to further determine the benefits and risks associated with the use of these products in children.

I also refer you to the previous responses FDA has provided you, and the FDA’s response to the 2012 Citizen Petition from the Empire State Consumer Project, available at http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0566-0006

REPORT AN ADVERSE EVENT TO THE FDA:

For information on how to submit an adverse event, see here:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of medical products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

BAYER STATEMENT:

Bayer Consumer Health has a long history as a leader in the manufacture and marketing of a broad range of over-the-counter (OTC) healthcare products and nutritional supplements. The health of our consumers is our top priority.

The MiraLAX brand became part of Bayer’s OTC portfolio in the United States in October 2014 with the acquisition of Merck Consumer Care. MiraLAX is an osmotic laxative that relieves occasional constipation. MiraLAX was introduced as a prescription laxative in February 1999 and was approved by the FDA as an OTC medication in 2006. OTC labeled dosing applies to adults and children 17 years and older for up to 7 days, unless otherwise directed by a doctor.

While MiraLAX is not labeled for use in the pediatric population, there have been many clinical studies conducted with PEG 3350 in pediatric populations which have demonstrated safety for short and long term use in children with a history of chronic constipation.

As part of Bayer’s ongoing commitment to consumer well-being, we regularly track, analyze and report all adverse event data related to the use of the product. Results of this ongoing monitoring support the continued safe use of MiraLAX.

With regard to the clinical study in question, it is a government-funded study by the National Institute of Health being conducted by the Children’s Hospital of Philadelphia. As Bayer is not involved in the study, any inquiries should be directed to them.

Category:

Detoxing, Uncategorized

Lyme Event in Chicago

Want to hear from doctors what Lyme is, what it isn’t, symptoms and risk, and be able to ask questions?

https://globallymealliance.org/events/evening-of-art-and-education-chicago-lyme-disease/

The Matthew Rachman Gallery in Chicago has graciously opened their space for a special evening. Two respected, Lyme-literate doctors, Dr. Casey Kelley and Dr. Chris Janson, will each present helpful information with a Q & A after.

The event will also serve to support GLA. 100% of ticket proceeds will go to GLA. In addition, 10% of all proceeds from art purchased at the Matthew Rachman Gallery, in person, March 9, 2017 – Sept 9, 2017, will be donated to GLA; simply mention “GLA”.

WHEN: March 9, 2017 – 6 pm to 8:30 pm

WHERE: Matthew Rachman Gallery, 1659 W Chicago Avenue, Chicago

ON EXHIBIT: SERIOUS/Play – Artwork by Amanda Gentry & Maura Segal

COST: $40 per ticket

Space is limited; purchase your tickets today (go to link above).

Category:

Uncategorized