IVERMECTIN: A Covid-19 Game-Changer?

Update: 12/17/2020

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. 

Dr Pierre Kory of FLCCC @ Congressional Hearing (12/8/2020) from LG on Vimeo.

DR. PIERRE KORY'S FULL CONGRESSIONAL TESTIMONY TRANSCRIPT (Dec 8, 2020)

I didn't think I'd have to say this, but I want to register my offense at the ranking members opening statement. I was discredited as a politician. I am a physician and a man of science. I've done nothing… nothing but commit myself to scientific truth and the care of patients. And, and to hear that I'm here because of a political angle, I am not a politician. I'm a physician. I want to start out by saying that I'm not speaking as an individual. I'm speaking on behalf of the organization, that I'm a part of. We are a group of some of the most highly published physicians in the world. We have near 2000 peer reviewed publications among us led by Professor Paul Marek who is our intellectual leader. We came together early on in the pandemic and all we have sought is to review the world's literature on every facet of this disease, trying to develop effective protocols.

You just mentioned that I was here in May and I recommended that it was critical that we use corticosteroids in this disease when all of the national and international healthcare organizations said, “we cannot use those”-- that turned out to be a life-saving recommendation.  I am here again today with a new recommendation. 

In the last nine months in our review of all of the literature (as a group… again, we are some of the most highly published physicians in our specialty and the world) -we have done nothing, but try to figure out how to identify a repurposed and available drug to treat this illness. We have now come to the conclusion after nine months (and I have to point out, I am severely troubled by the fact that the NIH, the FDA and the CDC) I do not know of any task force that was assigned or compiled to review repurposed drugs in an attempt to treat this disease.

Everything has been about novel and or expensive pharmaceutically, engineered drugs, things like Tocilizumab and Remdesivir and monoclonal antibodies and vaccines. We have (a) hundred years of medicine developed… we are experts in all the medicines we use, and I do not know of a task force that has been focused on repurposed drugs. I will tell you that my group /organization (has) filled that void. That is all we have done is focus on the things we know and things we do- and I'm here to tell you Dr. Rider- he just presented, he has one study of the many that I want to talk about. We have a solution to this crisis. There is a drug that is proving to be of miraculous impact. And when I say miracle, I do not use that term lightly.

And I don't want to be sensationalized; when I say that that is a scientific recommendation based on mountains of data that has emerged in the last three months. When am told (and I just had to hear this in the opening sentence) that we are touting things that are not FDA or NIH recommended. Let me be clear; the NIH-- their recommendation on ivermectin, which is to not use it outside of controlled trials is from August 27th. We are now in December. This is three to four months later. Mountains of data have emerged from many centers in countries around the world, showing the miraculous effectiveness of ivermectin. It basically obliterates transmission of this virus. If you take it, you will not get sick.

I want to briefly summarize the data. My manuscript-- we have contributed more to the medical knowledge of our specialty in our careers than anyone else can claim as a group and our manuscript, which was posted on medicine pre-print server details all of this evidence.  I want to briefly summarize it. 

#1. We have evidence that ivermectin is effective not only in prophylaxis (in the prevention). If you take it, you will not get sick. We just came across a trial last night from Argentina by the lead investigatoror ivermectin in Argentina, Dr. Hector Carbayo. They prophylaxed 800 healthcare workers--not one got sick.  In the 400 that they didn't prophylax with ivermectin, 58% got like 237 of those 400 got sick. If you take it, you will not get sick. It has immense and potent antiviral activity. We know that from the first study, it has made the bench to the bedside. Prophylaxis-- we now we have four large randomized controlled trials totaling over 1500 patients- each trial showing that as a prophylaxis agent, it is immensely effective. You will not get sick. You will be protected from getting ill if you take it.

In early outpatient treatment, we have three randomized control trials and multiple observation, as well as case series showing that if you take ivermectin, the need for hospitalization and death will decrease. The most profound evidence we have is in the hospitalized patients. We have four randomized control trials there, multiple observation trials, all showing the same thing. You will not die, or you will die at much, much, much lower rates. Statistically, significant, large magnitude results if you take ivermectin, it is proving to be a wonder drug. It has already won the Nobel prize in medicine in 2015 for its impacts on global health in the eradication of parasitic diseases.  It is proving to be an immensely powerful antiviral and anti-inflammatory agent. It is critical for its use in this disease. 

We, again, stand by our manuscript. It is a scientific management it's been submitted for peer review, but please recognize peer review takes time. It takes months. We do not have months. We have a hundred thousand patients in the hospital right now dying. I'm a lung specialist. I'm an ICU specialist. I've cared for more dying COVID patients than anyone can imagine. They're dying because they can't breathe. They can't breathe. They're on high-flow oxygen delivery devices. They're on non-invasive ventilators and or they're sedated and paralyzed and attached to mechanical ventilators that breathe for them. And I watched them every day. They die. By the time they get me in the ICU already dying, they're almost impossible to recover. Early treatment is key. We need to offload the hospitals. We are tired. I can't keep doing this. If you look at my manuscript and if I have to go back to work next week, any further deaths are going to be needless deaths. And I cannot be traumatized by that. I cannot keep caring for patients when I know that they could have been saved with earlier treatment and that drug that will treat them and prevent the hospitalization is ivermectin.

I am here today calling to action. The NIH, their last recommendation was August 27th. I want to be clear. I am not here as a politician or a dramatist or sensationalizing what I'm recommending. I'm going to be very clear and very simple. All I ask is for the NIH to review our data that we've compiled of all of the emerging data. We have almost 30 studies. Everyone is reliably and reproducibly positive showing the dramatic impacts of ivermectin. Please. I'm just asking that they review our manuscript. It is a serious manuscript by serious, highly experienced physicians and researchers. I cannot call on more credibility than we have. We're not just a random doctor who's saying that we have a cure. I don't want to say I have a cure. I'm just asking review our data. We have immense amounts of data to show that ivermectin must be implemented and implemented now.

Senator, the last thing I want to say is- you know, who's dying here? It's, it's our African-American and Latino and elderly. It's some of the most disadvantaged and impoverished members of our society. They are dying at higher rates than anyone else. It's the most severe discrepancy I've seen in my medical career. And we are responsible to protect those disadvantaged members. We have a special duty to provide countermeasures. The amount of evidence to show that ivermectin is life-saving and protective is so immense. And the drug is so safe. My colleagues have talked about it. It must be instituted implemented. I'm asking the NIH to review our data and come up with recommendations for society.

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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.

source: www.covid19criticalcare.com

I-MASK+ PROHYLAXIS / EARLY OUTPATIENT TREATMENT PROTOCOL & Ivermectin Suggested dose by body weight for prophylaxis and treatment of Covid-19

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

Review of the Emerging Evidence Supporting the Use of

Ivermectin in the Prophylaxis and Treatment of COVID-19

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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/

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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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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 comes 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 show up in the lymph nodes or 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 a genetic instability.

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. And so if that cancer cell recurs in the bone, the liver, the brain, the lungs it's left the Cedar breadcrumb. So we know it's more than just a cubic centimeter. That's already a billion cancer cells. So even if you cut it out, there's all these breadcrumbs that are already seated everywhere that we can't see.  There's going to be at least one resistant cell because it changes every DNA and 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 the drug or series of drugs, that 0.1% of eventually is going to come back. 

And that point we're 1% as it comes back, it 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 a new taste and change. HIV is the same way. So, but 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.

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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

 

EUROPEAN MEDICAL CONFIRM LUNG ULTRASOUND BENEFITS FOR COVID-19 TRIAGE

April 2, 2020 - Dr. Robert L. Bard, NYC imaging specialist collaborates with an international group of medical leaders including Dr. Danilo Buonsenso (Rome, Italy) who recently published reports about "ultrasound equipment as an effective replacement of the stethoscope.”  Dr. Buonsenso's review presents the valid uses and benefits of Lung Ultrasound in identifying respiratory disorders that may be associated with Covid-19.

Currently, front line physicians in Italy and Spain are reportedly triaging with portable ultrasound units that reduce logistical problems of a chaotic environment and healthcare worker exposure. Since imaging with CT or ultrasound is not diagnostic, determining who needs hospitalization is essential in a pandemic overwhelming medical providers.  Dr. Buonsenso, at the viral epicenter in Rome, uses sonograms to decide who requires a CT scan.

Sonogram taken under rib cage shows liver (grey) with curved diaphragm-
lung border (white) Arrows point to vertical B lines (white) demonstrating
diseased lung tissue.  The more B lines the worse the disease. Healing is
measured by reduction in the number of B lines

The use of CT lung imaging for COVID-19 has been recognized as the diagnostic standard during our current epidemic. Meanwhile, experts find CT to have  disadvantages like radiation exposure. Respiratory distress creates motion artifacts on images that may simulate pulmonary inflammation. Also, viral pneumonia is not diagnostically distinguishable from other viral inflammations in the lung so the argument for a screening modality is useful to separate the critically ill from those needing outpatient treatment.  This review was stated by Dr. Klaus Lessnau, author of "Atlas of Chest Sonography" (Springer 2003), employs both CT and ultrasound imaging in clinical practice.

Dr. Bard reviews international healthcare and technology updates as part of his continued research in the radiological society. This includes Dr. Buonsenso's national reports about the Covid crisis and the expanded use of lung ultrasound as part of his investigation of children as clinically unaffected carriers.  “The global pandemic demands effective answers toward a cure as well as protection of healthcare workers on duty", says Dr. Bard. "I have the highest regard for the European approach to problem solving both clinically and technologically… applying Dr. Buonsenso’s concept makes perfect sense to me and carries great value in our war against Covid-19.”

Ultrasound probes study the lungs between the ribs to
read the lung surface where most Covid pathology is situated

According to Dr. Bard, Lung ultrasound has been used in emergency rooms since it was introduced to the Mt Sinai Medical School in 2014 and is now used nationwide to diagnose pneumonia (viral or bacterial) in children which spares them unnecessary x-rays since it is so accurate. “It is like an electronic stethoscope since lung disease and heart failure producing pulmonary fluid buildup are diagnosed or confirmed with portable ultrasound units at the bedside. This is considered the best imaging tool to diagnose a collapsed lung in seconds which has proven lifesaving as a time saver for on the spot detection.”

In a recent telehealth conference, Dr. Bard explains how ultrasound probes study the lungs between the ribs to read the lung surface where most Covid pathology is situated.  (Image 1) Portable units have the advantage of containment within a sterile sleeve, preventing accidental viral spread to imaging equipment necessitating full decontamination procedures.  All clinical imaging was correlated with the patient’s oxygen saturation and clinical setting.     The virus has known cardiac toxicity so the same sonogram unit may image the heart for fluid buildup and weakened contraction. This may differentiate heart failure from pulmonary infection in some cases which may have similar clinical presentations.

About Dr. Bard

Dr. Robert Bard currently runs a private imaging center in NYC specializing in advanced 3-D sonography to detect cancer tumors and other health disorders.  He lectures in medical conferences worldwide, runs a cancer awareness program for first responders and is also a publisher of countless educational books and articles about cancer imaging and other health/wellness related materials.

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References

1) Is there a role for lung ultrasound during the COVID‐19 pandemic?  - Danilo Buonsenso https://onlinelibrary.wiley.com/doi/abs/10.1002/jum.15284

2) The Lancet: COVID-19 outbreak: less stethoscope, more ultrasound" https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30120-X/fulltext

Danilo Buonsenso | Davide Pata | Antonio Chiaretti - Published:March 20, 2020

3) Dr. Klaus Lessnau, author of "Atlas of Chest Sonography" (Springer 2003) https://link.springer.com/book/10.1007%2F978-3-662-05278-5

CANCER TREATMENT TECHNOLOGY REVIEW: ADVANCEMENTS IN PROTON THERAPY

By: Dr. Robert L. Bard & Cheri Ambrose
Edited by: Lennard M. Gettz / NY Cancer Resource Alliance

Medical researchers and developers have historically pursued many similar considerations in the path to improving cancer treatment solutions—much more than simply "killing cancer tumors."  The highest priority is typically given toward patient safety and well-being during and after treatment due to the use of highly powerful foreign elements like radiation and chemicals with heavy toxicity levels.

Such is the case with conventional X-ray (photon) treatments like intensity-modulated radiation therapy (IMRT), which has proven to be successful in killing targeted tumors but also can damage nearby tissue, thus causing injury to the patient.  IMRT applies high doses of irradiation in order to penetrate the body and reach the depths of the targeted tumor. This powerful beam of energy exposes all tissues along its entire path to radiation, including the normal tissues before the tumor and the normal tissues past the tumor.

 An upgrade from using x-rays in radiation therapy came with the delivery of charged (proton) particle beams (originated by Dr. Robert R. Wilson, 1946) to irradiate cancer. This dose is deposited within a controlled range of depth, affecting specific coordinates in the body so most of the dose is delivered to the actual tumor and little or no radiation is delivered to tissues beyond the tumor (called the Bragg peak). This technique, therefore, maximizes the chances of curing patients without cause debilitating side effects, as proton research shows promising results in reducing the damage to healthy tissues and better preserving patient quality of life.

The National Association for Proton Therapy (NAPT) reports that both standard radiation therapy and proton therapy to work on the same principle of damaging cellular DNA of tumor, with the major difference that proton therapy deposits the majority of the radiation dose directly into the tumor and travels no further through the body.  According to NAPT spokesperson Jennifer Maggiore, “The FDA approved this technology over 30 years ago, so it's not necessarily new, but recent advancements have made it more accessible in hospitals, and versions are also developed for single-room systems.” There are large “big scale” installations with a cyclotron that feeds three to four gantries. This takes up a big footprint of space and a major investment of time and money, which has led to the increase in smaller, single-room centers in recent years.

IMPROVING TRENDS IN CANCER TREATMENT
It is commonly observed that surgeons are increasingly using minimally invasive procedures.  Whether it's robotic or video assisted surgeries, we can identify the pattern of new treatment protocols to result in higher quality of life and a reduction in toxicity. In doing so, it allows us, in some cases, to actually improve survival through those same methods of reducing toxicities for patients.

According to Dr. Charles B. Simone II, Chief Medical Officer of the New York Proton Center, “We’re going to see more and more customized treatment; it's not a one size fits all approach to cancer. We are going to have individualized ways to deliver radiation therapy, individualized drugs or immune agents—and then, potentially more synergy between modalities such as radiation with systemic therapies.”

The concept of the pencil beam scanning or IMPT (intensity-modulated proton therapy) has grown widely accepted as the ‘new future’ in radiation therapy.  Originally recognized to treat brain tumors, proton therapy has since found global success in treating prostate, breast, liver, lung, head and neck, and other cancers.

In the recent past, proton therapy has continued to advance in its design and performance. Over the past two decades, the number of academically affiliated proton therapy centers in the United States has grown from zero to 31.  Over the past six years, newer centers have come onboard with pencil beam scanning proton therapy that has enabled IMPT. This new generation of proton therapy allows the radiation to be focused and deposited directly at the tumor, while avoiding normal tissues to an even greater extent than the first generation of proton therapy. Another unique advantage of the pencil beam scanning includes its ability to better sculpt the beam or dose.  To match the beam into the shape of the tumor (which is usually not a perfectly square, circle or rectangle shape) allows the deposit of more radiation into the tumor, as it travels into the patient, with even less radiation deposited in the normal tissues in front of and also after the tumor.

According to Dr. Simone, another recent advancement in proton therapy is the ability for physicians to apply volumetric imaging—or the ability to conduct low dose CT scans daily and immediately (in 3D) before treatment—to the targeted area. Volumetric imaging allows radiation oncologists to directly visualize the tumor, or the area that needs the treatment, without having to rely on bony anatomy as a surrogate, as most proton treatment installations do. Most proton facilities still use X-ray or KV images, rather than a cone beam CT image, limiting the ability to have millimeter precision.

Unlike devices such as the CyberKnife system with a regular linear accelerator that essentially plugs into the wall and generates its own radiation, proton therapy requires its own source of energy to generate the proton therapy. The most common model used by proton centers to generate protons, including at the New York Proton Center, is through a cyclotron—a 10-foot-wide machine that accelerates particles about two-thirds of the speed of light to generate protons. From there, the radiation gets siphoned out of the cyclotron through a beam line that's just a few inches wide, and goes into each of the clinical treatment rooms.

Proton therapy has been shown to reduce the risk of secondary cancers in patients, while decreasing the chance of any long-term complications from the treatment. For some cancers, including for most pediatric cancers, it has grown to be called the de facto standard of care, while for other cancers clinical trials are being conducted to determine it as the preferred treatment for specific patient populations.

FROM THE PATIENTS’ SIDE

After the patient’s radiation oncologist determines that they are qualified for proton therapy, patients would come in for a single preparation appointment, what's called a simulation or radiation mapping appointment.  This is generally done with an image (like a CT scan, a PET scan or an MRI), where the physician will work with a radiation physicist, as well as treatment planning dosimetrist, to map out the tumor in three or four dimensions.  This helps identify how to deliver radiation to that tumor while avoiding irradiation the normal tissues.

“There are several factors that help us determine the right form of treatment: the type of cancer, the tumor location and other patient characteristics. The length of the treatment varies depending on the case,” explained Dr. Simone. “Some patients will go through stereotactic proton therapy, which is generally between one and five day, and others will experience a more conventional treatment that's every day, Monday through Friday, for several weeks. While most treatments with proton therapy are the same number of days as with traditional x-ray therapy, because of the ability for protons to limit side effects, in some cases proton therapy can be administered to patients in high doses per day, leading to shorter treatment times, decreased cost, more patient convenience, and in some cancers better chances of cure.”

THE NEW YORK PROTON CENTER
July 2019 marked the opening of the 140,000 square ft. state of the art proton treatment facility on East 126th Street.  Managed by ProHealth medical group, the New York Proton Center was established under a joint partnership between Memorial Sloan Kettering Cancer Center, Mt. Sinai Health and Montefiore Health System. The New York Proton Center is projected to treat approximately 1,400 patients annually, receiving patients from its consortium partner institutions and from patients throughout the New York metro area and beyond who are looking for the most effective radiation care possible. The center will be one of the few worldwide that is equipped with the newest and most effective proton therapy technology, provided by globally renowned Varian Medical Systems, the worldwide leader in developing multidisciplinary, integrated cancer solutions.

ABOUT DR. SIMONE
Dr. Charles B. Simone, II is the Chief Medical Officer of the New York Proton Center. He is an internationally recognized expert in the use of proton therapy to treat thoracic malignancies and for reirradiation, and in the development of clinical trial strategies and innovative research in thoracic radiation oncology and stereotactic body radiation therapy. He is a National Institutes of Health, National Science Foundation, and Department of Defense funded investigator who performs clinical and translational research investigating the benefits of proton therapy as part of multi-modality therapy for thoracic malignancies. After years of dedication and service to the American College of Radiation Oncologists, Dr. Simone has been named a Fellow of ACRO, recognizing his highly valued contributions to the field. He has published over 340 scientific articles and chapters, given over 210 scientific lectures to national and international audiences, and is the national Principal Investigator or Co-Chair of 7 NIH-funded cooperative group trials (see complete bio- link https://www.nyproton.com/charles-simone/)


CONTRIBUTORS /  EDITORIAL TEAM

ROBERT L. BARD, MD, PC, DABR, FASLMS - Advanced Imaging & Diagnostic Specialist
Having paved the way for the study of various cancers both clinically and academically, Dr. Robert Bard 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 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, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. It is used as a complement to find anomalies and help diagnose the causes of pain, swelling and infection in the body’s internal organs while allowing the diagnostician the ability to zoom and ‘travel’ deep into the body for maximum exploration.

CHERI AMBROSE, Co-editor/outreach coordinator for NYCRA
Cheri is the associate editor for various publications such as PinkSmart News, the Journal for Modern Healing and First Responders Cancer News.  She is a patient advocate for many cancer-related programs and often contributes her time in cancer research fundraising events.  As the communications director for the NY Cancer Resource Alliance, she manages community outreach, partnership missions with other cancer foundations and research organizations and attends educational functions for cancer awareness. Her latest public projects include the launch of ImmunologyFirst.org and ImplantScan.org.  She stands as the current President of the male Breast Cancer Coalition (MaleBreastCancerCoalition.org).



Special Thanks
The NY Cancer Resource Alliance writing team and AngioMedical Publishing wishes to express its deepest and most heartfelt thanks to Dr. Charles B. Simone II for his kind generosity in sharing his vast knowledge about the science and technology of Proton Therapy.  Special added appreciation also belongs to the staff at The NY Proton Center including Patrick Curry and Miriam Mond for their support, and also to Nathaniel Goehring of Berlin Rosen Public Relations and Jane Fort and Jennifer Maggiore of the National Association of Proton Therapy (NAPT) - without whose coordinated efforts this project would not have been possible. 


References:
1) https://www.modernhealthcare.com/providers/proton-center-set-open-new-york
2) https://www.itnonline.com/article/trends-proton-therapy-%E2%80%94-faster-therapy-delivery-single-room-installs
3) https://www.manhattantimesnews.com/proton-powerpoder-de-protones/
4) https://www.mevion.com/newsroom/press-releases/mevion-s250-becomes-first-proton-therapy-system-approved-treat-cancer
5) Video: https://www.youtube.com/watch?time_continue=7&v=MS590Xtq9M4&feature=emb_title

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