Saturday, November 28, 2020

RE-ACCESSING UNUSED CANCER DRUG$ - A COST-CONSCIOUS INITIATIVE

"FACT: CANCER DRUGS ARE VERY EXPENSIVE AND NOT EVERYONE CAN AFFORD THEM! Just check out some price tags in this link @ GOODRX.com"

NYCRA News connected with Mr. Kirby Lewis, a 2x cancer victim and a survivor-crusader.  He and a handful of community leaders are framing a grassroots outreach program to explore new solutions to making cancer drugs accessible and affordable. "I came from a family that did not believe in hording, excess or wasting anything useful.  This is why it hurts to see my massive stockpile of unused cancer drugs from my episodes of treatment under the bathroom sink.  When I think about so many people out there who truly need and cannot afford any of this, I am compelled to find a way to save those lives through the redistribution of these meds.  I'd like to add that as a military vet, I am blessed with benefits to acquire my treatments and these drugs at no charge or a much reduced charge than most- where some of these doses cost in excess of $20-30,000 a shot."

Aptly called THE KIRBY PROJECT, Kirby's initiative speaks for the countless cancer patients in this country that do not have his type of medical support.  He added, "Insurance never covers everything- especially when it comes to drastic cases like cancer. If you're lucky, most insurance covers 50% - or even at the very best, 90% - and a vial of chemo that might be $20,000 you still have to pay a balance or a copay that can easily wipe your family out!" 

From his recent collaborative discussion with MBCC president Cheri Ambrose, references of drug prices and insurance coverage caps where heavily referenced to launch this point. "If you think about a range of drugs that cost anywhere between $71,000 to $27,000 for a 30-day supply, no insurance company would enjoy covering such a bill and chances are, they won't.  Carriers have been bankrupted, have DROPPED patients for situations like this or have simply rejected claims for this brand, replacing it with a lower cost (and possibly not as effective) alternative", states Ambrose.  


Diagram (L)- courtesy of goodrx.com/ data & report by: Lauren Chase & GoodRx research team -(8/11/2020). In an effort to continue to shed light on drug prices and increase transparency, the GoodRx Research Team regularly tracks the most expensive drugs in the U.S. Since 2018, we have tracked the list price and dosing requirements to identify the most expensive drugs. Here we look at the most expensive drugs that patients can get at a pharmacy and administer themselves. This list does not include medications that must be administered by a healthcare practitioner. In March, the GoodRx Research team put together the list of the most expensive drugs including those that must be administered by a medical professional. 

 See complete article.


According to recent NIH reports, pharmaceutical donation and reuse programs are distinct prescription drug programs providing for unused prescription drugs to be donated and re-dispensed to patients since 1997. -- but the operative term here is UNUSED. Once a drug touches the home and the hands of a consumer, the value, safety and guarantee of that drug for its intended function DISAPPEARS (see complete details below/ Plan B)


THE KIRBY PROJECT:
 
UNITING TO RESOLVE THE DEADLY PRICE TAG OF CANCER MEDS

According to a report from the NIH, "the cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase. 

Recently, first started a discussion with a handful of cancer survivors and org leaders from the NY Cancer Resource Alliance and Dr. Robert Bard (CancerScan Center) who were very supportive of my idea and were willing to help me convert this into a real initiative.  Before I knew, it, more and more people joined in to brainstorm about how to appeal to the pharma companies and (hopefully) discover the WIN-WIN together.  We looked into the many legal parameters and even searched for the right legislators to help build an awareness platform that might help leverage change from the top down.  It was clear that we were going to need a lot more friends to make a dent at this.  A sensible first base was to connect with all the community groups and cancer foundation leaders or anyone in a leadership role who recognizes this economic dilemma and "the real price of cancer". 

WHY CAN'T WE REUSE EXPENSIVE (UNUSED) DRUGS?
In a series of panel discussions to explore opportunities to address the astronomical cost of cancer medication, we kept returning to a plan of SUSTAINABILITY.  We explored the policy of re-purposing, re-selling or donating what is commonly identified as USED, UNWANTED or SURPLUS DRUGS.  

https://www.pbs.org/newshour/health/tylenol-murders-1982 

While carrying tremendous merit, in accordance with laws about recycling drugs, this concept in its raw form violates various public safety guidelines.  ANY drug that has left the authorized distributor and whose seal is broken are called this, hold a tremendous liability for safety, leaving open to massive potential lawsuits from the manufacturer, the distributor and the prior owner- should any issues/side effects or injury occur upon re-use. (source: https://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx)

PLAN B:  According to the NSCL (National Conference of State Legislatures),  pharmaceutical companies are able to subscribe to the national Pharmaceutical Donation and Reuse Programs - providing unused prescription drugs to be donated and re-dispensed to patients. Since 1997, 38 states have participated in this program. (See complete NSCL news). Safety restrictions carry strict guidelines as to who can donate and what types of prescription products may be donated.  


QUESTIONING HIGH-COST DRUGS

Excerpted from "The Cost of Oncology Drugs: A Pharmacy Perspective, Part I"

"Health care costs are the fastest growing financial segment of the U.S. economy. The Centers for Medicare and Medicaid Services (CMS) estimates health care spending in the U.S. will increase from $3.0 trillion in 2014 to $5.4 trillion by 2024.1 About 19.3% of the U.S. gross domestic product is consumed by health care, which is twice that of any other country in the world. It is often stated that the increasing cost of health care is the most significant financial threat to the U.S. economy. The cost of medications, including those for treating cancer, is the leading cause of increased health care spending."

See this complete report on NIH/PubMed




VIEWPOINTS: FROM THE PROS

Robert L. Bard, MD, PC, DABR, FASLMS
Like Kirby, I am a former military physician with global experience in pharmaceutical kinetics.  We have long known that the effective life of many medications extends months and possibly years after the expiration date (artificially mandated by governmental agencies).  With copycats [from other countries], faulty manufacturing practices or careless packaging, many products found on the market are either ineffective or harmful.  An example, I recently learned about foreign copycats are drug formulas that have been stolen and replaced - like “hair crème” being passed off as penicillin at some US bases. Prices in the US or overseas facilities are significantly higher than in most hosting nations. While initial cost of creation and FDA acceptance is staggering, so is the payback of a successful launch for such drugs as anticholesterol agents. One must recognize that individual tolerance and therapeutic delivery vary greatly so a personal validation of the treatment is useful.  Many “cures” may kill the disease but devastate the patient as well in the process, both economically and healthwise.  Caveat emptor- make sure it works and investigate the side effects.

Cheri Ambrose
(President, Male Breast Cancer Coalition)
I hear from survivors all the time who have lost their jobs, their homes, and in some cases their families while navigating a cancer journey. The stress of the diagnosis and treatment alone can be insurmountable.  Add to that the startling cost of drugs needed to fight the disease and you have the makings of a Perfect Storm.   Patients should never have to make the decision to choose between putting food on their table or treating their disease.  Pharmaceutical companies can and should do more to help those uninsured, underinsured, or otherwise financially stressed patients.  I also feel the Insurance industry should do more to ease the burden of cost on patients being treated for cancer. After all, people don't choose cancer, Cancer chooses them. 








MICHAEL'S CHOICE:
A Different End-of-Life Plan
By: Lorraine S. Davi (San Francisco, CA)

Every cancer advocate carries a story that inspired their personal mission to help others.  A rare and compelling one is about accepting and surviving the passing of a cancer victim who chose the uncommon path of facing their fate and living the rest of his days without any cancer-fighting treatment.










MORE:

1) https://canceradvocacy.org/kirby-lewis-cpat-symposium-hill-day-experience/

Please email us your comments on this article at: editor.prevention101@gmail.com

Disclaimer: The NY Cancer Resource Alliance publishes subscription based non-commercial news articles, educational reports and feature coverage for web distribution in the healthcare and cancer communities. All contributors are volunteers and submissions are provided to us at the discretion of the writer.   Prevention101.org, Fightrecurrence.com and The HealthNews section of NYCRANEWS are free public educational programs published by The New York Cancer Resource Alliance (NYCRA) - a self-funded network of volunteers comprised of caregivers, accredited medical professionals, cancer educators, publishers and published experts, patient support clinicians and non-profit foundation partners whose united mission is to bring public education and supportive resource information to the community of patients, survivors and any individual(s) seeking answers about cancer. NYCRA is an exclusive, non-commercial private network originally established on the LINKEDIN digital society and is supported in part by the AngioFoundation whose mission is to share informative materials to the community. For more information, visit: www.NYCRAlliance.org. Our VIEWPOINTS section shares editorial perspectives supporting the main topic(s) in is issue and the contributors credited may expand on the current topic, sharing other views that may or may not align directly with said topic, such that the publishers of this newsletter does not necessarily agree with, share or endorse.


Monday, November 16, 2020

IVERMECTIN: A Covid-19 Game-Changer?

The publisher(s) and editor(s) of this publication does not necessarily reflect the views presented in this segment and does not guarantee any data or technical content referenced herein. All excerpts, article links or video segments are provided with express approval from their direct sources.


TOP-SPOT NEWS:


Front Line Covid Specialists: "NIH- Please Read our Data!"

On Dec 8, 2020, committee chairman Republican Sen. Ron Johnson called ICU Pulmonary specialist Dr. Pierre Kory of the Aurora St. Luke’s Medical Center (WI) and president of the FLCCC to the US Senate Homeland Security and Governmental Affairs Committee.  The hearing was called “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II.”  Dr. Kory gave his testimony on behalf of frontline physicians about the current state of care in the Covid pandemic and what his group specifies as the logic-based treatment with scientifically proven data that he pleads the NIH to review.  (See complete video and Transcript of Dr. Kory's Testimony)





November, 2020, the world is almost one year deep into the CoronaVirus pandemic, falling into a third infection surge.  The global health community floats the latest report of a near-ready deployment of the Covid vaccine while ICU reports a new spike in cases in all 50 states.

WHAT IS IVERMECTIN?
According to health officials at the FLCCC (Front Line Covid-19 Care Alliance), a new report of a prophylactic solution & a treatment protocol for Covid-19 infection is available in the global market NOW. This community of intensivists in FLCCC expresses tremendous confidence in this clinical strategy with climbing evidence of success domestically and abroad., "... in keeping with the robust and emerging evidence reviewed above, the Front Line COVID-19 Critical Care Alliance recently created a prophylaxis and early treatment approach for COVID-19 called “I-MASK+”. This protocol includes IVERMECTIN as a core therapy in both early treatment and prophylaxis of both high-risk patients and post-exposure to household members with COVID-19 . The Front Line COVID-19 Critical Care Alliance is committed to measuring outcomes in those treated with ivermectin and reviewing all emerging results from the current and any future clinical trials of Ivermectin in COVID19"

Will ivermectin interfere with the vaccine and can I continue to take ivermectin once vaccinated?
Our understanding of the importance of ivermectin in the context of the new vaccines, is that ivermectin prophylaxis should be thought of as complementary bridge to vaccination until the vaccines are made available to all those in need. At this time and speaking with the vaccine experts we do not believe that ivermectin prophylaxis interferes with the efficacy/immune response to the vaccine, however it must also be recognized that no definitive data exists to guide use more specifically on this question. However, given that maximal immunity from the vaccines is only achieved 2 weeks after the second dose of vaccine, it is reasonable to take bi-weekly ivermectin until this time point. The “New’ mutated strain of SARS-CoV-2 appears to be less susceptible to pre-existent neutralizing antibodies; this may have potential implications for the current vaccination program.

For complete information on IVERMECTIN, see the FAQ section of the FLCCC site (link)


NOT JUST FOR SCABIES... IVERMECTIN FOR COVID-19 SHOWS SUCCESS FROM ICU DOCS
By: Dr. Robert L. Bard 


If you looked up IVERMECTIN in 2019 or earlier (pre-pandemic), you may find it as a topical anti-bacterial to popularly treat SCABIES (and kill scabies mites).  It is also known as an oral antiparasitic agent approved for the treatment of worm infestations. Evidence suggests that oral ivermectin may be a safe and effective treatment for scabies; however, ivermectin is not FDA-approved for this use.  [4-cdc]. Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei var. hominis). The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Scabies is found worldwide and affects people of all races and social classes. Scabies can spread rapidly under crowded conditions where close body and skin contact is frequent. Institutions such as nursing homes, extended-care facilities, and prisons are often sites of scabies outbreaks. Child-care facilities also are a common site of scabies infestations. [5-cdc]

In addition, Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular species for which they are labeled. Using these products in humans could cause serious harm. [6-fda

Today, a unified global voice in the medical community for alternative care of Covid-19 infection is offering new scientific data supporting the surprising benefits of Ivermectin. The FLCCC (Front Line COVID-19 Critical Care Alliance) reported over 30 countries from Europe, the Americas, Asia and Africa now have growing communities of subscribers to this protocol, employing and attesting to the positive response that Ivermectin appears to provide in the prevention or care of Covid patients. According to Dr. Paul Marik of Eastern Virginia Medical School, "There is no one silver bullet... there are a few things that we should be doing simultaneously to control the virus. There is now overwhelming evidence is profoundly efficient in treating this disease- in preventing it early and in the late phase... what makes Ivermectin truly a remarkable drug is that not only is it a potent antibacterial and an anti-viral drug (but) it is a potent anti-inflammatory drug. So it's all the 'magic' you want in one pull" (see Dr. Marik's complete video interview)

 Also: see Prophylaxis & Early Outpatient Treatment Protocol for Covid-19 (source: FLCCC)

Contributor:

ROBERT L. BARD, MD, PC, DABR, FASLMS
Recipient of nationally acclaimed Ellis Island Award (2020) for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 


The following overview is a repost of the current feature published by the FLCCC Alliance and Dr. Pierre Kory. 

Review of the Emerging Evidence Supporting the Use of Ivermectin in the Prophylaxis and Treatment of COVID-19

In March 2020, an expert panel called the Front Line COVID-19 Critical Care Alliance (FLCCC) was created and led by Professor Paul E. Marik with the goal of continuously reviewing the rapidly emerging basic science, translational, and clinical data in order to gain insight into and to develop a treatment protocol for, COVID-19. At the same time, many centers and groups employed a multitude of novel therapeutic agents empirically and within clinical trials, often during inappropriate time points during this now well-described multi-phase disease. Either as a result of these frequent trial design failures or due to the lack of their insufficient anti-viral or anti-inflammatory properties, nearly all trialed agents have proven ineffective in reducing the mortality of COVID-19. Based on a recent series of negative published therapeutic trial results, in particular the SOLIDARITY trial, virtually eliminates any treatment role for Remdesivir, hydroxychloroquine, lopinavir/ritonavir, interferon, convalescent plasma, tocilizumab, and mono-clonal antibody therapy.

Despite this growing list of failed therapeutics in COVID-19, the FLCCC recently discovered that ivermectin, an anti-parasitic medicine, has highly potent real-world, anti-viral, and anti-inflammatory properties against SARS-CoV-2 and COVID-19. This conclusion is based on the increasing numbers of study results reporting effectiveness, not only within in-vitro and animal models, but also in numerous randomized and observational controlled clinical trials. Repeated, consistent, large magnitude improvements in clinical outcomes have now been reported when ivermectin is used not only as a prophylactic agent but also in mild, moderate, and even severe disease states from multiple, large, randomized and observational controlled trials. However, the review that follows of the existing evidence for ivermectin relies on “emerging” data in that, although convincing, as of November 14, 2020, only a minority of studies have been published in peer-reviewed publications with the majority of results compiled from manuscripts uploaded to medicine pre-print servers or posted on clinicaltrials.gov. 
The most recent paper, currently in production, reports a 6.1% hospital mortality rate in COVID-19 patients measured in the two U.S hospitals that systematically adopted the MATH+ protocol, a markedly decreased mortality rate compared to the 23.9% hospital mortality rate calculated from a review of 39 studies including over 165,000 patients (unpublished data; available on request). For a review of the therapeutic interventions comprising the current MATH+ protocol.

source: www.covid19criticalcare.com
Although the adoption of MATH+ has been considerable, it largely occurred only after the RECOVERY and other trials were published which supported one of the main components (corticosteroids) of the combination therapy approach created at the onset of the pandemic.4-9 Despite the plethora of supportive evidence, the MATH+ protocol for hospitalized patients has not yet become widespread. Further, the world is in a worsening crisis with the potential of again overwhelming hospitals and ICU’s. As of November 10th, 2020, the number of deaths attributed to COVID-19 in the United States reached 245,799 with over 3.7 million active cases, the highest number to date. Multiple European countries have now begun to impose new rounds of restrictions and lockdowns. Further compounding these alarming developments was a wave of recently published negative results from therapeutic trials done on medicines thought effective for COVID-19, that now virtually eliminate any treatment role for remdesivir, hydroxychloroquine, lopinavir/ritonavir, interferon, convalescent plasma, tocilizumab, and mono-clonal antibody therapy, particularly in later phases.

One year into the pandemic, the only therapy considered “proven” as an effective treatment in COVID-19 is the use of corticosteroids in patients with moderate to severe illness.18 Similarly most concerning is the fact that little has proven effective to prevent disease progression to prevent hospitalization.

Ivermectin, an anti-parasitic medicine whose discovery won the Nobel Prize in 2015, has proven, highly potent, anti-viral and antiinflammatory properties in laboratory studies. In the past 4 months, numerous, controlled clinical trials from multiple centers and countries worldwide are reporting consistent, large improvements in COVID-19 patient outcomes when treated with ivermectin.




Despite this growing list of failed therapeutics in COVID-19, it now appears that ivermectin, a widely used anti-parasitic medicine with known anti-viral and anti-inflammatory properties is proving a highly potent and multi-phase effective treatment against COVID-19. Although much of the trials data supporting this conclusion is available on medical pre-print servers or posted on clinicaltrials.gov, most have not yet undergone peer-review. Despite this limitation, the FLCCC expert panel, in their prolonged and continued commitment to reviewing the emerging medical evidence base, and considering the impact of the recent surge, has now reached a consensus in recommending that ivermectin for both prophylaxis and treatment of COVID-19 should be systematically and globally adopted.

The FLCCC recommendation is based on the following set of conclusions derived from the existing data, which will be comprehensively reviewed below:

1) Since 2012, multiple in-vitro studies have demonstrated that Ivermectin inhibits the replication of many viruses, including influenza, Zika, Dengue and others 

2) Ivermectin inhibits SARS-CoV-2 replication, leading to absence of nearly all viral material by 48h in infected cell cultures

3) Ivermectin has potent anti-inflammatory properties with in-vitro data demonstrating profound inhibition of both cytokine production and transcription of nuclear factor-κB (NF-κB), the most potent mediator of inflammation 

4) Ivermectin significantly diminishes viral load and protects against organ damage when administered to mice upon infection with a virus similar to SARS-CoV-232

5) Ivermectin prevents transmission and development of COVID-19 disease in those exposed to infected patients

6) Ivermectin hastens recovery and prevents deterioration in patients with mild to moderate disease treated early after symptoms 




7) Ivermectin hastens recovery and avoidance of ICU admission and death in hospitalized patients 

8) Ivermectin reduces mortality in critically ill patients with COVID-19

9) Ivermectin leads to striking reductions in case-fatality rates in regions with widespread use

10) The safety, availability, and cost of ivermectin is nearly unparalleled given its near nil drug interactions along with only mild and rare side effects observed in almost 40 years of use and billions of doses administered 

11) The World Health Organization has long included ivermectin on its “List of Essential Medicines”

Exposure prophylaxis studies of Ivermectin’s ability to prevent transmission of COVID-19

Data is also now available showing large and statistically significant decreases in the transmission of COVID-19 among human subjects based on data from three randomized controlled trials (RCT) and one retrospective observational study (OCT); however, none of the studies have been peer-reviewed yet.

The largest RCT was posted on the Research Square pre-print server on November 13, 2020 while the two other RCT’s have submitted data to clinicaltrials.gov, which then performed a quality control review and posted the results. The OCT was posted on the pre-print server medRxiv on November 3, 2020.

The largest RCT by Elgazzar and colleagues at Benha University in Egypt randomized 200 health care and households contacts of COVID-19 patients where 100 patients took a high dose of 0.4mg/kg on day 1 and repeated the dose on day 7 in addition to wearing personal protective equipment (PPE), while the control group of 100 contacts wore PPE only.52 There was a large and statistically significant reduction in contacts tesing positive by RT-PCR when treated with ivermectin vs. controls, 2% vs 10%, p<.05.

The second largest RCT, conducted in Egypt by Shouman et al. at Zagazig University, included 340 (228 treated, 112 control) family members of patients positive for SARS-CoV-2 via PCR.

Ivermectin, (approximately 0.25mg/kg) was administered twice, on the day of the positive test and 72 hours later. After a two-week follow up, a large and statistically significant decrease in COVID-19 symptoms among household members treated with ivermectin was found, 7.4% vs. 58.4%. Similarly, in another RCT conducted by Carvallo et al. in Argentina involving 229 healthy citizens, 131 were randomized to treatment with 0.2mg of ivermectin drops taken by mouth five times per day. After 28 days, none of those receiving ivermectin prophylaxis group had tested positive for SARS-COV-2 versus 11.2% of patients in the control arm (p<.001).53 More recently, in a large retrospective observational case-control study from India, Behara et al. reported that among 186 casecontrol pairs (n=372) of health care workers, they identified 169 participants that had taken some form of prophylaxis, with 115 that had taken ivermectin prophylaxis (n=38 of the COVID-19 cases and n=77 of the controls). After matched pair analysis, they reported that in the workers who had taken two dose ivermectin prophylaxis, the odds ratio for contracting COVID-19 was markedly decreased (0.27, 95% CI, 0.15–0.51). Notably, one dose prophylaxis was not found to be protective in this study.

Based on both their study finding and the Egyptian prophylaxis study, the All India Institute of Medical Sciences included a consensus statement in the manuscript recommending health care workers take two 0.3mg/kg doses of ivermectin 72 hours apart and to repeat monthly.

Further data supporting a role for ivermectin in decreasing transmission rates can be found from South American countries where, in retrospect, large “natural experiments” appear to have occurred. For instance, beginning as early as May, various regional health ministries and governmental authorities within Peru, Brazil, and Paraguay initiated “ivermectin distribution” campaigns to their citizen populations. In one such example from Brazil, the cities of Itajai, Macapa, and Natal distributed massive amounts of ivermectin doses to the city’s population, where, in the case of Natal, 1 million doses were distributed.45 The data in Table 2 below was compiled on September 14, 2020 and was obtained from the official Brazilian government site (https://covid.saude.gov.br) and the national press consortium by an engineer named Alan Cannel whose findings were published on the website TrialSiteNews and are thus not peer-reviewed. 

For the complete report, visit: www.covid19criticalcare.com



VIEWPOINTS

CONRAD G. MAULFAIR, DO. - Osteopathic Physician | Allentown, PA 
"
Dr. Kory's testimony to a Congressional Hearing on the benefits of a 40 year history in clinical medicine of a simple and inexpensive drug repurposed for the treatment of his current Covid 19 patients could not be more important in these times.  The clinical experience and research of a physician who cares passionately about his patients, as well as the current state of worldwide treatment for Covid victims, is critical in overcoming our problems.  He is an inspiration to all physicians and patients alike.  It is common practice for us to utilize available drugs in "off label" application where our patient's health is our responsibility and clinical experience as well as the literature supporting our prescription.  What he is recommending has been done continually for years and years by physicians who care for patients. He uses ivermectin because it helps his patients.  We need to use ivermectin in the manner recommended as well as any other effective protocol shown to be helpful in patient care for our patients."

ROBERTA KLINE, MD  - Obstetrics/Gynecology & Genomic Education |  Santa Fe, NM
"This is an amazing SUCCESS story of using science to guide a collaborative effort to solve clinical challenges quickly. From my perspective of supporting each person's biochemistry for health, I'm glad to see they included antioxidant and vitamin support to enhance efficacy. But this story is also one that highlights the frustration around politics, money and power controlling low-cost, innovative solutions that are more effective than pricey designer drugs. This information needs to get out. NOW. We may now have a vaccine that can help in the long term, but people are getting sick and dying in record numbers. My neighbor is a nurse administrator at our local hospital here, where COVID is finally overwhelming them and they have shut down elective surgeries for the first time in the pandemic. I have reached out to her to share this information and hope approval can be expedited so this can make a difference." 

ANNELIES MOONS, MD - Gen. Practitioner & Lifestyle Medicine | Belgium
"I have reviewed all of the testimonials before the US Senate Homeland Security and Governmental Affairs Committee and was very impressed with Dr. Kory's emotional testimony. Today it is difficult to decide who to believe, but this doctor takes the Hippocratic Oath very seriously. I am a general practitioner living in Belgium. ... I have my doubts about the new vaccine as long as there is no more data about its efficacy in the long term. In recent weeks I have posted links on articles about Ivermectin in response to articles about the covid pandemic in medical press. Ivermectin is only on the market here in Belgium in cream form.  I hope your work is rewarded and more and more doctors are discovering the potential of this drug for covid19. But you can imagine, the new vaccine is produced here in Belgium. Ivermectin can serve the patients at risk in addition to the vaccine. Humanity owes the corona crisis to itself, more will come if we don't change course. I wish you and your team success, but I am sure,  if you are right, you will achieve your goal." 

RAKHIM TOJIBOEV, MD - Cardiac Anesthesia / Intensive Care | Uzbekistan
"
I am a cardiac anesthesiologist and intensivist which allows me to work on a different level with critical patients. I am the only member of FLCCC from former Soviet Union countries and am the only one in my country who uses this (MATH+) protocol. I am very proud that I started using this protocol in many patients and I can see faster recovery from Covid-19. Unfortunately, we do not have Ivermectin in our country but I would like to say that the MATH+ protocol works very well even without Ivermectin.  My whole work is based in world standards. This war urged us to work differently... in order to get good results."

NOELLE L. CUTTER, Ph.D  - Molloy College | Assoc. Professor of Biology & Chemistry | NY
"The incredible work that has emerged from the group of scholars working on the MATH+ formula for patient care reminds me of the importance of collaboration in medicine.  This treatment formula was designed with patient care in mind, during an unprecedented time in our history.  The formula has clearly been shown to be an effective treatment to combat the virus.  The combination of Corticosteroids, Ascorbic acid and Heperin has effectively been shown to reduce severity of patient symptoms and greatly reduce the need for the ventilator.  This is certainly a step forward in treatment options for COVID19 patients."   - 

ELIZABETH BANCHITTA - EMT / Medical Student - NY
"I feel 
Dr. Kory's testimonial - it comes from the deep end of the ICU where most of the patients are extremely critical and there's not that many interventions that would make much of a difference.  I can't imagine being so highly trained and knowing exactly how something works and thinking, 'I know this will work but I can't give it to my patients and they're going to die possibly for no reason'.  Meanwhile, we don't know how the vaccine is going to play out, but regardless of that, there needs to be other resources."



COUNTERPOINT

FROM THE NIH

COVID-19 TREATMENT GUIDELINES: IVERMECTIN Last Updated: August 27, 2020

"Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.1 It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.2 For these indications, ivermectin has been widely used and has demonstrated an excellent safety profile. Recommendation: The COVID-19 Treatment Guidelines Panel recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial (AIII). The available clinical data on the use of ivermectin to treat COVID-19 are limited."  See complete NIH report and references: https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/

 




RELATED FEATURES:

Methylprednisolone or Dexalmethazone? A Strategic Treatment Challenge From The Field
T
eams of American physicians like Dr. Pierre Kory, Pulmonary and Critical Care Specialist (Milwaukee, WI) and his team of front-line Covid care providers (the Front Line Covid-19 Critical Care Alliance) challenged Dexamethasone as the exalted panacea of the pandemic.  Dr. Kory’s team dedicated their life’s work to the research and treatment of infectious diseases in critical illness, and recently published a battle-tested and proven Hospital Treatment Protocol called MATH+,  a combination of medicines designed to counteract the injurious hyperinflammation, hypercoagulability, and hypoxemia in COVID-19 using synergistic actions. Their group strongly recommends a different corticosteroid called METHYLPREDNISOLONE.   Work done by members of the group, in particular, Dr. G. Umberto Meduri, one of the worlds experts on the use of corticosteroids in critical illness, discovered key findings establishing the rationale in support of the preferred use of Methylprednisolone, while also providing a wider scope of evidence supporting corticosteroid therapy for Covid-19 critical cases. 



ON PREVENTION: Survival Guide from ICU Docs + THE FOUR D'S of Airborne Transmission

"Arguably, most doctors are not like INTENSIVISTS (ICU specialists)... they are the last line with the dying and (those with) the most severe illnesses. They are conditioned to work creatively and more aggressively under a major time limit... to reverse life threatening disorders." Read about how front line ICU docs maintain their health through the Covid pandemic.  Review their latest safety protocols in  INFECTION CONTROLS of routine mask wearing, regular hand-washing and gown donning. Get additional insight on supplements and a comprehensive review of how to truly manage airborne pathogens. (see complete article)





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Sunday, November 8, 2020

CANCER RECURRENCE: Viewpoints and Strategies




INTRODUCTION:
WHY CANCER COMES BACK
(Source: NIH- National Cancer Institute)

When cancer comes back after treatment, doctors call it a recurrence-  or recurrent cancer. Finding out that cancer has come back can cause feelings of shock, anger, sadness, and fear. But you have something now that you didn’t have before—experience. You’ve lived through cancer already and you know what to expect. Also, remember that treatments may have improved since you were first diagnosed. New drugs or methods may help with your treatment or in managing side effects. In some cases, improved treatments have helped turn cancer into a chronic disease that people can manage for many years.

Recurrent cancer starts with cancer cells that the first treatment didn’t fully remove or destroy. This doesn’t mean that the treatment you received was wrong. It just means that a small number of cancer cells survived the treatment and were too small to show up in follow-up tests. Over time, these cells grew into tumors or cancer that your doctor can now detect. [1]


RECURRENCE & METASTASIS- THE MOVING TARGET   By: Dr. Ben Ho Park

There are two flavors of recurrence- one being LOCAL recurrence and the other is METASTATIC. Local recurrence means that should for whatever reason some cancer tissue or cells get left behind, cancer can come back (a curable situation). In the case of breast cancer (per se), recurrence can also mean METASTATIC- where it can re-appear outside the breast area and outside of the lymph nodes in the armpit.  Now it doesn't mean it's not treatable, but it essentially means that the cancer now has traversed from the local area to a distant site, set up shop and grown to a point where it's now detectable in higher numbers.

Recurrence is really a math game. The numbers would tell you that by the time that happens, there's so many cells and so many cell divisions that the heterogeneity of cancer (the main treatment challenge) prevents us from being able to cure metastatic disease, because we don't currently have enough drugs that can get rid of all of those different cancer cells. A patient's breast cancer, as an example, is not uniform. It's a dynamic process. Every time a cancer cell grows and divides those two daughter cells (if you will) are slightly different from one another.  Whereas normal cells are exactly the same when they grow and divide-- they have to be (they're identical twins), this is the problem with cancer; it is a disease of DNA gone bad, but it's also underlying of what we call genetic instability that leads to heterogeneity making cancer cells resistant to many drugs.

As far as heterogeneity, by the time you can see a cancer tumor at one centimeter, that's a billion cancer cells, and they're all a little bit different from one another. And so if that cancer cell recurs in the bone, the liver, the brain, the lungs it's left a trail of breadcrumbs. So we know it's more than just a cubic centimeter. That's already a billion plus cancer cells. So even if you cut it out, there's all these breadcrumbs that are already seeded everywhere that we can't see.  There's going to be at least one cancer cell resistant to a given therapy, because of all the changes in DNA as cancer cells divide, meaning the cancer cell from one to the next is a little bit different. And that's what makes cancer so tough to beat because we're not dealing with a static target. We're dealing with a moving target. And even though we can get 99.9% of the cells with a drug or series of drugs, that 0.1% of cells left behind is eventually going to come back.

And that point when it comes back, cancer cells gets even more heterogeneity and more changes and more, again, evolution of different subclones as we call it. That's the fundamental crux and problem with cancer and why it's so tough to beat. And this is not different when you think about some infectious diseases like tuberculosis, right? I mean, that's why we need four drugs to cure patients with tuberculosis because it evolves and changes. HIV is the same way. So, I also use those examples to point out we've controlled those diseases. In some cases, we cured those diseases and we can do the same for cancer.


OUTSMARTING CANCER WITH SELF-AWARENESS   Dr. Robert L. Bard

Once you do enough Google-searching-especially for key terms like "CANCER PREVENTION" and "STAY IN REMISSION", you'll learn how to come up with a simple plan to keep cancer away- or increase the likelihood of beating cancer with the comprehensive Early Detection & Prevention plan. In each case, much can be done to prevent the current stage. The first step is to GET MORE FAMILIAR WITH YOURSELF.

• Be aware of your genetic lineage: risk of cancer increases upon heredity. The first place to look is within your own dna or family history. Many cancers tend to travel down generations. It can also have the tendency to skip one generation and appear in the next one.

• Periodic Checking of your body for any anomalies like lumps, bumps, discolored bruises or growths. Self-checking is the first base. Also stay on top of unusual feelings like frequent headaches, unique pains and strains- anything that feels out of the ordinary. Take nothing for granted when it comes to your body.

• Know your environment: Many health issues are known to be caused by environmental toxins. Where you sleep, eat and work could be affecting how you feel later. Some health hazards are fairly visible and apparent while others may need some historical research in your area where there may have been potential chemical wastes or spills in the past. If you know of such issues, further research, demographic studies, protective measures and targeted checkups may be your next step.



METASTASIS: RECURRENCE WITH A VENGEANCE
By: Kirby Lewis

 In 2012, I was diagnosed with stage two (male) breast cancer.  Standard operating procedure was having me undergo a mastectomy to my left breast.  It came with all the physical impact of treatments and surgery but I wasn't too worried about the outcome. I was sure that it wasn't going to kill me because I found that most people don't die from stage one, two or three.

 Then, by 2016, I had recurrence. As a lot of people know, recurrence is about 30% of early stagers.  I sensed the first time that it was going to come back-- and that when it did, it was going to be metastatic.   Metastasis is when those rogue cancer cells that are in the area of the breast tissue decide to venture out into another neighborhood of the body. When that happens, they tend to go to the liver or the pancreas or, the kidneys or the bones or even the brain. I had metastases in both lungs and in my spine so it was quite alarming.  

Through a battery of testing, it was unnerving to find out how fast it went from being non-present in my body to being everywhere-- in my lungs and in my spine. Basically, I was looking at a six week period where I went from clear lungs, clear scans and within six weeks, my, my lungs lit up like Christmas trees.

I think that what people can learn from this is that you should never take the changes in your body lightly. Do self exams. And if you find something that is unusual, go have it checked out. It's $50 for a doctor visit and that's $50 well spent rather than buying a coffin. If your body has propensity to turn on those cancer cells, flip that switch, then (my thinking is that) it's likely that it is going to come back in some other form. And I hope that it doesn't. When someone is designated cancer free, I would love for them to think that that's it. But they do need to be diligent. And they do need to be cognizant and aware of the fact that the possibility will always exist.

References:

1) https://www.cancer.gov/types/recurrent-cancer




The New York Cancer Resource Alliance is committed to seeking out SMART SCIENCE from the top sources of current and most helpful solutionists. Because there is no SILVER BULLET to cancer, a recent article from our generous friends at Boehringer-Ingelheim shed some light into some of their greatest cancer findings from recent research work about "undruggable" targets and their views on how to approach them.

Despite significant progress over recent decades, many key molecular drivers for a wide range of cancers remain undruggable. Only 10-15% of cancer patients currently benefit from drug treatment targeting the genomic aberrations driving their cancer. Our mission is to change this. We’re taking cancer on by working on pioneering approaches to identify key cancer cell dependencies that drive the growth and proliferation of cancer cells. Our scientists are developing novel therapies to turn these drivers off, and combining them with specially selected partners to switch off multiple drivers, as well as with immunotherapy to harness the patient’s immune system to fight cancer cells.

FINDING SMART COMBINATIONS TO TACKLE ‘UNDRUGGABLE’ TARGETS
 
We’re digging deep into the science and taking a precision approach to develop smart combinations to bring the greatest benefit to patients. The first step is to find cancer-cell directed therapies that induce rapid tumor shrinkage. But we know that the long-term efficacy of current targeted therapies has been limited by the development of resistance, leading to relapse and disease progression. Cancer cells quickly find ways to circumvent the effects of targeted drugs by mutating or re-routing along alternative pathways. So we’re using a smart science approach to understand molecular pathways at a deep level to identify the ‘Achilles heels’ where we can potentially outwit the cancer cells at the same time as finding innovative ways to increase and prolong anti-cancer effects with combination partners.

Immune therapies often take longer to act than cancer cell-directed therapies but can achieve much more long-lasting responses. So part of our smart combination strategy is exploring how to transform ‘cold’ tumors, which have no, or limited, immune system activity, making them unresponsive to immuno-therapy, into ‘hot’ tumors so that the patient’s immune system can be recruited to fight cancer with immuno-oncology therapies. By combining both approaches, patients gain the immediate benefit and high responses of cancer-cell targeted therapies and the longer-term survival benefit of immunotherapy. (See complete article: A Smart Science Approach to Cancer Combinations- by Norbert Kraut, Ph.D., Global Head of Cancer Research, Boehringer Ingelheim)

Thursday, November 5, 2020

INHERITING CANCER

CANCER HEREDITY
Cancer is a genetic disease—that is, cancer is caused by certain changes to genes that control the way our cells function, especially how they grow and divide. Genes carry the instructions to make proteins, which do much of the work in our cells. Certain gene changes can cause cells to evade normal growth controls and become cancer. For example, some cancer-causing gene changes increase production of a protein that makes cells grow. Others result in the production of a misshapen, and therefore nonfunctional, form of a protein that normally repairs cellular damage.  

Inherited genetic mutations play a major role in about 5 to 10 percent of all cancers. Researchers have associated mutations in specific genes with more than 50 hereditary cancer syndromes, which are disorders that may predispose individuals to developing certain cancers. Genetic tests for hereditary cancer syndromes can tell whether a person from a family that shows signs of such a syndrome has one of these mutations. These tests can also show whether family members without obvious disease have inherited the same mutation as a family member who carries a cancer-associated mutation. [1]


Everyone has two copies of each set of genes from both parents. If a person inherits a mutation in a Lynch syndrome gene, they still have the normal copy of the gene from the other parent. Cancer occurs when a second mutation affects the normal working copy of the gene, so that the person no longer has a copy of the gene that works properly. Unlike the inherited Lynch syndrome mutation, the second mutation would not be present throughout the person’s body, but would only be present in the cancer tissue. However, not everyone with Lynch syndrome will get cancer. You and your family members are more likely to have Lynch syndrome if your family has a strong history of colorectal cancer. Family members who inherit Lynch syndrome usually share the same mutation. If one of your family members has a known Lynch syndrome gene mutation, other family members who get genetic testing should be checked for that mutation. (source: CDC.gov)

GENETICS VS. GENOMICS

Excerpted from www.genomicmedicineworks.com

Genetics and genomics sound alike and are often used interchangeably, yet important scientific and clinical distinctions exist between these two scientific fields of study. The classical definition of genetics is the study of heredity, how characteristics and traits (phenotypes) of a living organism are transmitted from one generation to the next. This occurs via deoxyribonucleic acid (DNA), a double helix molecule in the cell’s nucleus that comprises genes—the basic unit of heredity. Many of the early principles and rules of heredity were discovered by an Augustinian monk and scientist, Gregor Mendel. His seminal research with pea plants in the mid-1800’s laid the foundation for modern-day genetics.

Genomics is the next evolution of classical genetics, and became possible only in recent decades due significant advances in DNA sequencing and computational biology. In 1976, Belgian scientists succeeded in fully sequencing the genome of bacteriophage MS2, a bacteria-infecting virus. They identified all 3,569 DNA base pairs, and the 4 nucleotides (Adenosine, Cytosine, Guanine and Tyrosine) that make up the DNA code. The first animal genome was completely sequenced in 1998. Five years later, with more than 1,000 researchers from six countries collaborating on the Human Genome Project, all 3.2 billion DNA base pairs in the human genome were identified.  Genomics is the study of the entirety of an organism’s genes—the genome. Genomic researchers analyze enormous amounts of DNA-sequence data to find variations that affect health, disease or drug response. In humans, that means searching through about 3.2 billion units of DNA across 23,000 genes.


In a clinical sense, genetics is the study of single genes or parts of genes and their effects on a person’s development, disease risk or response to drugs. This is generally referred to as a “monogenic” approach, since the focus is on a single gene. In contrast, genomics is the study of the function and interactions of all the genes in the genome.

While genetics and genomics are still quite distinct in how they impact health and disease, scientists are starting to view genetics and genomics as part of a continuum. On one end of the spectrum are single gene disorders with high penetrance – meaning if you have the mutation, you get the disease. On other end are genomic SNPs, which are common, low penetrance gene variants from multiple locations interacting with environmental factors, leading to complex diseases. Unlike genetic mutations, SNPs don’t automatically cause disease.

Genomic Medicine: It is now possible to use results from clinically-based genomic testing to evaluate a person’s disease susceptibility, and develop evidence-based, personalized intervention strategies to reduce those risks. These strategies include DNA-directed lifestyle modifications, dietary recommendations, nutritional supplements and/or exercise, all of which influence how these genes function to create health or disease. Biomarker testing can then be used to evaluate whether the intervention is efficacious. With this approach, the guess-work and inefficiencies of trial-and-error strategies are greatly reduced, leading to better health more quickly and cost-effectively.

Our comprehensive Ultimate Wellness genomic test provides gender-specific reports to create personalized programs for many health conditions, including:

  • Prevent ER+ breast cancer or its recurrence in women diagnosed with the condition
  • Reverse osteopenia and osteoporosis
  • Prevent or treat Type II diabetes, heart disease, stroke, metabolic syndrome and obesity.
  • Optimize athletic performance
  • Customize nutrient requirements and resolve nutritional paradoxes
  • Prevent, treat and manage depression and anxiety
  • Plus many more health and wellness issues
  • Genomic Medicine is personalizing healthcare with precision. 

To see complete article, visit: https://genomicmedicineworks.com/genetics-genomics/


About the Author

ROBERTA KLINE MD
Co-Founder & CEO of Genomic Medicine Works. Board-certified Ob-Gyn physician, author, educator, genomics expert and entrepreneur, Dr. Kline is passionate about helping others harness the power of personalized, DNA-directed healthcare. Dr. Kline graduated magna cum laude and Phi Beta Kappa from the University of Connecticut. She received her medical degree from the University of Connecticut School of Medicine under an Air Force Health Professions scholarship, and completed her Obstetrics and Gynecology residency at Wright Patterson AFB earning multiple honors. Today, she brings her expertise in healthcare, practice development, genomic science and education, clinical and genomic medicine along with Human Design to Genomic Medicine Works.



Directory of Inherited Cancer Syndromes source: NIH LINK
• BRCA1 / BRCA2 - breast & ovarian cancer
• Cowden Syndrome
• Diaphyseal medullary stenosis
• Duodenal carcinoid syndrome
• Endolymphatic sac tumor
• Familial adenomatous polyposis
• Familial isolated pituitary adenoma
• Gardner syndrome
• Hereditary diffuse gastric cancer
• Hirschsprung disease ganglioneuroblastoma
• Langerhans cell histiocytosis
• Li-Fraumeni syndrome
• Lynch syndrome
• Multiple endocrine neoplasia:
- (type 1
 | type 2A | type 2B)
• MYH-associated polyposis
• Oslam syndrome
• Paraneoplastic Neurologic Disorders
• Perlman syndrome
• Pheochromocytoma | islet cell tumor synd.
• Premature aging Okamoto type
• Stewart Treves syndrome
• Von Hippel-Lindau disease
• WAGR syndrome

 LYNCH SYNDROME is a hereditary cancer condition in which a mismatched repair gene, which ordinarily repairs errors in DNA duplication, is defective. As a result, individuals are predisposed at a very high lifetime risk of cancer, including an up to 85% risk for colorectal cancer, 65% risk for uterine cancer, 19% risk for gastric cancer, 13% risk for ovarian cancer and a higher than average risk for other cancer including cancers of the liver, gallbladder, kidney, bladder, prostate, pancreas, skin, brain and breasts. With genetic testing, there is hope...once diagnosed, annual cancer screenings take place and cancers can be treated or removed before becoming life threatening. By knowing our family history and having a great medical team, we live longer than ever before...as long as anyone else!




An Introduction to Lynch Syndrome
By: Lindy Bruzzone

I was diagnosed in 2007 with colorectal cancer which was tied to my having Lynch Syndrome.  There are tens of thousands of people now diagnosed with this genetic disorder which means this is NOT a RARE disorder like most might think.  It came from a defective mismatch repair gene, where instead of repairing errors in DNA replication, it puts in different proteins and create more errors than it tries to keep doing. 

I produced this video 10 years after I lost lost my father. It was just so difficult for me to lose him that way. The day before he died, he said to me, "the doctors think it's hereditary, go get checked and tell your brother and sister, to get checked."  After his funeral, my brother and I started looking for the right cancer center to get help. Knowing my father's reports, my surgeon and other doctors jumped in to get me tested, and sure enough--- it was positive. 

That's why Lynch Syndrome International was developed because nobody was getting diagnosed. NOW they are! And then when Color Genomics was developed (a Steve Jobs startup offering for FREE genetic testing), suddenly everybody started getting tested because they could finally afford it. They didn't want insurance companies involved. It took care of every barrier that we have to testing for hereditary cancers. 

tbc


References

1) Cancer Heredity / NIH: https://www.cancer.gov/about-cancer/causes-prevention/genetics