Saturday, November 28, 2020

RECYCLING EXPEN$IVE CANCER DRUG$ - A SUSTAINABLE CONCEPT

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

My name is Kirby Lewis and I am a 2x cancer victim (and a survivor-for-now). I was raised from a family that does not believe in excess or wasting resources.  This is why it hurts to see my massive stockpile of unused cancer drugs under my bathroom sink, when I think about so many people out there who truly need and cannot afford any of this.  

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 cost in excess of $20-30,000 a bottle. But for so many cancer patients in this country that do not have this form of help, how on earth can anyone afford this?  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! 

If you think about a range of drugs that cost within $71,000 to $27,000 for a 30-day supply, no insurance company enjoys covering such a bill.  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.  At the end of the day, "something's gotta give!" 

According to 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).


FRAMING THE KIRBY PROJECT: LOOKING FOR THE "WIN-WIN"
 
Recently, I reached out to Cheri Ambrose, president of Male Breast Cancer Coalition and top partner of the NY Cancer Resource Alliance and Dr. Robert Bard (NY CancerScan Center) who were very supportive of my idea and were willing to help me explore the imbalance of all this. We brainstormed at how to appeal to the decisionmakers at the pharma companies and (hopefully) bring them onto our side.  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.  Unfortunately, this raised many  safety concerns of potential injury to the end user from countless means (ie. malicious drug tampering or accidental contamination). 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 below.  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)

  • Only professionally-designated persons are allowed to make a donation. Some states do allow individuals patients to donate directly. Pills in opened or partly used bottles are never accepted.  Old drugs are never accepted.  Expiration dates must be visible, and often at least six months later than the date of donation.
  • Commonly, donated drugs must be delivered to a specific type of medical or pharmacy facility.  Some may require the donor to sign a form or waiver. 
  • Financial compensation or payment to the donor is usually prohibited. Donations may be tax-deductible if paid for by the individual patient and taxpayer.  Beyond donation programs, patients and other individuals may not sell any prescription drugs; such transactions are strictly regulated by State Boards of Pharmacy and other state and federal laws.
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.  No unsealed bottles of pills are accepted. Expiration dates must be visible, and often at least six months later than the date of donation.  Though other initiatives concerning the re-purposing medicines for affordability to the less fortunate are not evident, it appears this Reuse Program shows varying flexibility per state and may be open to expansion.


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.



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.

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.3 Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government. However, that discussion is outside the scope of this article.

Charles Moertel and colleagues published a landmark trial 25 years ago, which reported that treatment with fluorouracil and levamisole for 1 year decreased the death rate of patients with stage C (stage III) colon cancer by 33% following curative surgery.7 Although this trial was clinically significant, there was as much discussion about the high cost of levamisole (Ergamisol) tablets as there was about its clinical benefit for patients.

In a 1991 letter to the New England Journal of Medicine, Rossof and colleagues questioned the high cost of the levamisole in the treatment regimen.  Rossof and colleagues were surprised at the drug’s price on approval, about $5 for each tablet, and detailed their concerns on how this price was determined. “On the basis of the cost to a veterinarian, the calculated cost of a hypothetical 50-mg tablet should be in the range of 3 to 6 cents,” they argued. The total cost to the patient of 1 year of treament was nearly $1,200. Their conclusion was that “…the price chosen for the new American consumer is far too high and requires justification by the manufacturer.” A reply from Janssen Pharmaceutica, the drug’s manufacturer, offered many justifications for the price.8 According to the company, Ergamisol was supplied free to 5,000 research patients prior to FDA approval. It was also given for free to indigent patients...  The cost of levamisole was $1,200 per year in 1991, and after adjustment for inflation would cost about $1,988 in 2015, or $166 per month. If these prices caused outrage in 1990, it is easy to see how current prices of well over $10,000 per month for therapies, which often render small clinical benefits, can seem outrageous by comparison.

See this complete report on NIH/PubMed





MICHAEL'S CHOICE:
THE STORY BEHIND THIS AD
By: Lorraine S. Davi (San Francisco, CA)

In April of 2008, my (then) fiancée Michael received his colonoscopy report showing scans of a golf ball-sized tumor in his colon.  Michael was always a bit closed about his family, but it was then that I learned about his parents' history of hereditary cancers and the rare genetic disorder that ran through his father's side called Lynch Syndrome.  

As shocking as the diagnosis was, we were even more stunned to receive Michael's reaction-- what seemed like a pre-written plan to something that he seemed to expect was going to happen.  "My whole family is a ticking time-bomb and I guess now is my turn", he said, with an icy calm. "Since I was a kid, I've been thinking about how to handle this if and when it was going to come. I made a simple plan to live out the rest of my life the best way I can-- not putting ANY attention to (this) cancer.  This means NO treatments or spend a second fighting the inevitable".

At first, I found his view to be bold, yet selfish. How could he do this to his loved ones? But the more I thought about it, maybe WE were the selfish ones to make him undergo all those horrible exposures to painful chemotherapies and radiation at the hopes of keeping him around indefinitely.  Either way, this was unlike any other reaction I have ever heard of when someone gets diagnosed.

Just so happens, I spent years as a volunteer fundraiser to a handful of cancer organizations and knew then that there was no shortage in cancer research programs for any kind of cancer.  I have read and reported about so many treatment protocols, clinical trials and diagnostic innovations where the race for a cure is definitely at the highest point ever.  By this, there is always hope.  But regardless of generations of advancements at our grasp, Michael's decision was firm.  He always believed that his limited TIME and MONEY should be best spent living each moment, and not "gamble on hope."

By the fall of 2009, Michael passed away, but not without fulfilling his so called "set of Hurrahs".  The crescendo of this final days left behind a stark silent emptiness in the hearts of many.  But to some of us, the fight for a cure is even more prevalent than ever. I may not be an oncologist or a genetic specialist, but Michael's story shaped my crusade to PREVENT anyone else from quitting this way.  I became a resource fiend, researching and cataloguing all available resources for cancer patients.  From personal grants to treatment alternatives to  housing help to the smallest wish and possible need - literally everything is available and accessible!



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

Is IVERMECTIN the New Covid-19 Game-Changer?

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.

 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"

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.

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.



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




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.

Results

  • Ivermectin administration was reportedly consistent with hospital guidelines: a single dose of 200 µg/kg, with repeat dosing on Day 7 if the patient was still hospitalized (13 patients received a second dose). Ninety percent of the ivermectin group and 97% of the usual care group received hydroxychloroquine (the majority received hydroxychloroquine in conjunction with azithromycin).
  • All-cause mortality was lower among the patients in the ivermectin group than among patients in the usual care group (OR 0.27; P = 0.03). The mortality benefit appeared to be limited to the subgroup of patients with severe disease.
  • There was no difference between the groups for the median length of hospital stay (7 days in both groups) or the proportion of mechanically ventilated patients who were successfully extubated (36% in the ivermectin group vs. 15% in the usual care group; P = 0.07).

Limitations

  • This was a retrospective analysis.
  • The study included little or no information on oxygen saturation or radiographic findings. It was also unclear whether therapeutic interventions other than hydroxychloroquine, such as remdesivir or dexamethasone, were used in the study.
  • The timing of therapeutic interventions was not standardized; if the timing is not accounted for, it can bias the survival comparison.
  • The analyses of the durations of ventilation and hospitalization do not appear to account for death as a competing risk.
  • No virologic assessments were performed.
See complete NIH report and references: https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/

 




RELATED FEATURES:

METHYLPREDNISOLONE OR DEXALMETHAZONE?: STRATEGIC TREATMENT CHALLENGE FROM THE FIELD Teams 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.


VIEWPOINTS: "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 the 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."   Dr. Noelle Cutter (Molloy College | Associate Professor of Biology and Chemistry) 


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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

 


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)


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!



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

 


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

Wednesday, November 4, 2020

Reduce Your Exposure to Harmful Chemicals - by Dr. Aly Cohen


Dr. Aly Cohen, founder of The Smart Human®, discusses many of the everyday chemicals in our food, drinking water, cookware, cleaning products, personal care products, and even in the air we breathe are not tested for safety that can cause both short and long-term health issues. 

Here are five things you can do right now to reduce exposure from harmful chemicals.

1) DECREASE CANNED FOOD AND DRINKS. Canned food and drinks, yes soda too, all have a lining of plastic material made from BPA or bisphenol-A, a compound that was found to mimic estrogen and other hormones in the body. Resulting in a variety of hormone related health issues like thyroid disease, developmental issues in children, insulin resistance in diabetes, high blood pressure, obesity, and some cancers. Try buying fresh foods or frozen produce and prepared meals, and heat them up in glass containers and not the steam bag that they came in.

2) AVOID COOKING IN NON-STICK PANS. The chemicals used on these pans break down and get into the foods that you're cooking. These non-stick chemicals, also called perfluoralkyls have been shown to cause cancer in laboratory animals, and are made using fluorine, an element which takes decades to breakdown in our bodies and in our environment. You may have to use a bit more elbow grease to clean your pans, but stick with cast iron or stainless steel and look for 18/8 on the bottom that let's you know it's food grade steel. Use real olive or coconut oil instead of synthetic non-stick sprays.

3) NO MORE PLASTIC for storage and microwave use. Ever wonder why clear plastic containers turn cloudy after running through the dishwasher a few times? Plastic breaks down over time, from high heat from dishwashers and microwaves and even from scratches. This breakdown can release harmful chemicals into your food in the container, especially food that has high fat content because many of the plastic chemicals are lipophilic or fat loving. It's well worth your time to take a few extra seconds to transfer prepared foods into a glass container before heating it up in the microwave, and store foods in glass or stainless steel too.

4) CREATE A WATER SYSTEM no matter if your water comes from an in-ground well or city water from a water treatment plant. Always filter your water at the point of use, which is your faucet. This allows you the greatest control of what you and your family drink. Now there are simple carbon filters that are used in pitchers, on refrigerator doors, as well as those you can actually install onto your sink faucet. Then there are more complicated filters such as reverse osmotic, ion exchange, and distillers. Choosing the right filter for you and your family is very important, and the best resource for this is ewg.org guide to buying a water filter. Whichever type of filter drinking water system you choose, remember to change your filters regularly and carry your water in glass or stainless steel.

5) DUST, MOP & VACUUM WEEKLY. In many studies household dust has been found to contain hundreds of chemicals that come from products we use in our homes every day. Children and household pets have been shown to have the highest levels of many harmful chemicals such as flame retardants, plasticizers, smoking chemicals, cleaning product chemicals in their bodies because they're on the floor where dust collects and sticks to toys, fingers, and paws.

Of course making all of these changes doesn't happen overnight. Try making one healthy change per month. Taking the time to think about the products we use everyday can help minimize chemical exposures and create a safer and healthier home and human body.

I share these prevention tips and more on TheSmartHuman.com website and on Facebook, Twitter, and Instagram. Thanks for joining me, I'm Dr. Aly Cohen and remember, when it comes to our environment and our health, you too can be the smart human.

The Smart Human LLC. seeks to educate, coach, and empower everyday people to make safer, smarter choices for human health. Our goal is to help hospitals, schools, and manufacturers, make changes to reduce unsafe chemical exposure of  the children and adults that they serve. It’s a lofty goal, but it has to start somewhere! I hope you will join us on this mission.


Additional videos are available with topics including: Chemicals in Personal Care Products, Improving Poor Air Quality and Making our Drinking Water Safer. Check out the complete set of episodes of THE SMART HUMAN Video Channel.






IMMUNOLOGY AND THE SCIENCE OF SELF-HEALING  By: Dr. Jesse A. Stoff
To help restore our health and to help restore harmony, it's a matter of rebuilding the immune response. A functional immune system is based upon an intact biochemistry, which means our biochemistry, the system of biochemical substances, hormones, enzymes and the like in our body has to be intact, functional and in balance, one to the other, in order to support the immune system as efficiently as is possible. Together, they work together to protect us from all sorts of illnesses and keep us above ground on the shiny side of the grass that much longer. When we're looking at the immune system, it's actually a bridge. A bridge where? A bridge between our biochemistry and a bridge in the sort of metaphysical sense to our higher self... -go to full article


RESPIRATOR vs. SURGICAL MASK - What's the Difference?  
By: Dr. Robert L. Bard
Fact: ANY PPE is better than NO PPE!  The science of prevention states that measures toward a reduction in risk can greatly support life-saving others - and yourself.  Meanwhile, discerning the difference between face coverings, specifically MASKS vs RESPIRATORS can be useful in identifying which situation to use which type of mask. There is a significant difference between the two, and wearing one vs. the other provides differing results. The FDA defines a surgical mask as a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment... -go to full article






This newsletter series is produced by: The New York Cancer Resource Alliance (NYCRA) -- a self-funded union 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


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