The Medical News Report

August, 2021 # 115

Samuel J. LaMonte, M.D., FACS

www.themedicalnewsreport.com

Subjects:

1. COVID-19 update, spikes, Delta variant, school guidelines, new treatments, immunity good for those previously infected; weekly changes in mask guidance

2. Cardiomyopathy  

3. Changes in medications for asthma inhalers

4. Gouty Arthritis

5. New oral drug for daytime drowsiness from obstructive sleep apnea

 6. The polypill

IMPORTANT REMINDER!!!! PLEASE READ!!!

  I remind you that any medical information provided in these reports is just that…information only!! Not medical advice!! I am not your doctor, and decisions about your health require consultation with your trusted personal physicians and consultants.

  The information I provide you is to empower you with knowledge, and I have repeatedly asked you to be the team leader for your OWN healthcare concerns.  You should never act on anything you read in these reports. I have encouraged you to seek the advice of your physicians regarding health issues. Feel free to share this information with family and friends, but remind them about this being informational only. You must be proactive in our current medical environment and help the doctors an dother providers to keep you as healthy as possible.

  Don’t settle for a visit to your doctor without them giving you complete information about your illness, the options for treatment, care instructions, possible side effects to look for, and plans for follow up. Be sure the prescriptions you take are accurate (pharmacies make mistakes too) and always take your meds as prescribed. The more you know, the better your care will be, because your doctor will sense you are informed and you expect more out of them. Always write down your questions before going for a visit.

  Thank you, Dr. Sam

I donated 2 units of blood (one whole blood and one red cells only)! The country is in great need of donated blood. Give the gift of life!!!

1. COVID-19 updates, variants, vaccines, school rules, new therapies, mandates, and much more

So much has happened in July, that I have had to revise this report almost weekly. The past few days has been a game changer, and like it or not, there will be more restrictions coming. The Delta variant has been the difference, but may not be around a whole lot longer, as it is waning in India and the UK, which was ahead of us. We will see. But the administration is making major changes assuming it is going to be around for a while.

  Please read the entire report as it is filled with new data and does raise some questions about the use or misuse of medical data and governmental overreach!

A. Vaccinations

  The number of cases of COVID-19 is 95% less than when it was at its highest in the U.S. in January 2021, however the delta variant is changing that some. The delta variant now accounts for 83% of cases in the U.S. and is much more infectious (more transmittable) than the other variants.

  Now there is concern that those with natural infection are not well protected from the delta variant without much medical data to back it up. I have data in this report to refute that, but it was before the delta variants. The CDC says that vaccinated people are as easy to transmit the virus as those who are not. Where is the data?? Assumptions are being made without hard data.

  What they don’t state, which is proven, is that if a vaccinated person transmits the illness, it will likely be very mild, except in those with underlying disease.

  The rate of those previously vaccinated that have had a breakthrough infection is 0.04%. The COVID rates are rising and some areas of the country and have increased hospitalizations but few deaths, much different than before. 95% are unvaccinated.

  It is known that the best way to prevent infection is to be vaccinated and very likely will keep a person out of the hospital if a breakthrough infection occurs. This virus is not going away, so we need to respect it.

  The rising cases are 95% in unvaccinated are mainly in the low vaccination states (the South including Florida) between ages 29-40 and rates are said to be rising across the country, since there still is a large number who are not vaccinated (100 million). 163 million have been vaccinated, but the fear of the delta variant is motivating some to get the vaccine.

  Children are not being infected at a greater rate especially under 12, and yet the CDC is recommending masking all school children with little science to back it up other than it being difficult to police who is vaccinated and who is not.

  This age group (29-40) that have low vaccination rates and milder disease forget they may have an underlying medical disorders or someone at home who could face a more severe case. However, the delta variant is well covered by the vaccines (88% from the AMA News), especially in preventing hospitalizations and death.

  100 million Americans are eligible for the vaccine, who have not received it. Come on America!!

Breakthrough infections in the vacccinated

  Those vaccinated who are frail, older, and immunosuppressed are more likely to get the variant if their vaccine did not create a strong immunologic response, so these individuals must more be cautious and may require boosters in the future. Certainly these people if unvaccinated need to have a serious discussion with their doctor about getting vaccinated.

  The delta variant data does show that one person now infected could potentially infect 10 people compared to previous variant cases that could infect potentially 3-4 people.

  The unvaccinated are still clearly the most vulnerable. Florida is now called the epicenter of cases, with rising hospitalizations in those ages 20-50, who are unvaccinated.

  The last week of July Florida had 110,724 new cases up 40% from the previous week. Sarasota Memorial Hospital just reinstated a no visitor rule, because of the high transmission statistics.

  If one looks at the underlying diseases of these unvaccinated people, they are mostly overweight, diabetic, or have other medical illnesses that need monitoring more than the actual COVID itself. If you are vaccinated and healthy, you should be safe, but still need to be smart about exposures.

  The people who filled our hospitals early on in this pandemic were over 60, but they got vaccinated (80% over 60) and continue to be more cautious than younger people.

  Medscape Medical News, July 19, 2021

Why do we let illegals with COVID-19 come to our country??

  25% (of those selectively tested) of the younger people coming over our border are COVID-19 positive, according to some news media, while the majority are not even being tested, and they are being sent all over our country (2 million illegals by year end) primarily to the South and Southwest to spread COVID-19!! This is in the face of our administration stating that the border is closed.  

  Why would this administration allow individuals into our country carrying this virus when they want people safe and vaccinated?? And those illegals who were offered the vaccine, only 30% agreed to it, according to one report.

 Mask guidance from the CDC

  Dr. Rochelle Walensky, Head of the CDC, did not give us medical data that was sufficient to back up their decisions on masks, and pushing for near mandates. Now they recommend that all people should wear masks indoors (including all school children) if they live in an area that is seeing a surge. I expect lockdowns to follow, sadly!! People not vaccinated or those even vaccinated with underlying disease or older should consider masks, but now the rest of us (who are vaccinated and healthy) may be required to wear masks inside!!! Where is the medical data? Mannequin studies at Mayo Clinic are not sufficient, and one outbreak at a Cape Cod resort does not meet the national standards for flipping on guidance.

    With mask requirements for the vaccinated, it is going to discourage a number of those considering vaccination, but the delta variant will motivate some.

  Mandating vaccines is going to be a hard sell and Biden is on the verge of mandating vaccination or punishing all federal employees who are not vaccinated(requiring them to get tested weekly, socially distancing, with no official travel allowed). The VA has already mandated vaccination for all healthcare workers, and in my opinion those who care for patients should be vaccinated. First responders and hospital employees continue to report 30-40% of these people are not vaccinated, which is about the national average. No excuses!

B. Immunity in the previously infected  

  The same antibodies rise in infected and vaccinated individuals including memory T and B cells, and neither those vaccinated or infected is it known how long the immunity will last for sure (now estimated to be 1 year), but it does raise the question of boosters yearly just like the flu.

  The Journal, Cell Reports Medicine, July 21, 2021,  reported that infected individuals* (mostly mild and moderate cases) have a sustained and good antibody response (>250 days=8 months) which to date appears to be as good as the vaccine, according to this published journal article. Neither is for more than a year, and only time will tell with the delta variant. THERE IS NO DATA TO PROVE THAT PREVIOUSLY INFECTED INDIVIDUALS ARE NOT PROTECTED.

*these study groups were selected from Fred Hutchinson Center in Seattle, Wash., and Emory Medical Center in Atlanta

  Small studies have proven that infected and vaccinated individuals have essentially the same number of breakthrough infections. That may change as the delta variant travels through our country. This virus is changing and we must adjust our thinking as it changes. That is the true value of public health.

  This study states that their results refute the assumption that infection causes only short term antibody response. The fact that memory T- and B-cells and plasma cells are formed coincides with long term protection from future exposures. We will see how the delta variant stands up to this research.

? Home Antibody Testing; PCR testing for the virus

  It would be valuable to have a home (reliable) antibody test to prove immunity or not, but since the FDA states that these tests for the general public are unreliable for determining immunity or protection. Antibody levels can’t prove degree of protection with testing. They are only reliable in detecting exposure to COVID-19. Essentially it is a research tool, which is cited in most research papers. Medscape Medical News, May 19, 2021

  I remnd the reader that our best diagnostic test for whether an individual is test positive or not, is only 60-70% effective. Sad that both the antibody levels and even the gold standard for testing has so many false negatives.

CDC recommendations for those previously infected    

  The CDC currently recommends vaccination for those who have been infected (3 months after the infection). Regardless, these individuals who have been previously infected make up 30-40% of the population, and so many never knew they were infected.

  Considering 50% of the population (66% of adults) have been vaccinated plus the estimate of 30-40% of the population who have been infected, that meets the criteria for herd immunity for some independent experts. The delta variant could change that issue, but we need published peer reviewed data to make decisions on, not bureaucracy.

  Studies do show the immune response can rise even higher with the addition of a vaccine if an individual is previously infected (50-100% higher), but, as stated, there is no specific level of immunity known to be more or less protective.  Science Journal, June 14,2021

Boosters

  No study has answered the question about the need for boosters, but experience and observational studies in Israel suggest boosters will be needed on or before a year after initial vaccination. First, lets get vaccinated now and choke out the delta variant.  

Mixing vaccines

  On another note, Lancet, July 17, 2021 reported in a Spanish study mixing Astra Zenica vaccine followed by a second dose of Pfizer had a good and maybe even better immunologic response as the same vaccine.

C. Current vaccination rates in the U.S.-where are we? Mandates from the Biden Administration?

  Pfizer should have full FDA approval of their vaccine by the fall. Children under 0-12 should be approved in the next month or so, according to the AMA News. There is still controversy whether whole populations of this youngest age group should be vaccinated considering the low rate of infection.

  President Biden sought a 70% vaccination rate initially (currently 51% of all Americans)because his experts stated that it would essentially attain herd immunity at that rate. Why leave out those who have natural immunity from COVID-19 infection?? It is the combination that will attain herd immunity which some experts feel has already been attained in most of the country now, but again, the delta variant may change the thinking on this once we have studies on these two groups. And now the federal employees are facing vaccination, attesting to having had the vaccine, or if not vaccinated, having to wear a mask at work, socially distancing, and not allowed to travel for official federal business. That goes for federal contractor companies.

  Dr.Walensky, in a press conference on June 30 on Fox News, had no hard data to back up the CDC’s new recommendations (I remind you these are guidelines not rules), but the feds take it as gospel, and I am sure are putting major pressure on the CDC to come out with these more stringent guidelines.

   Only 66% of those over age 18 have had at least one dose of vaccine, while 80% of those over 60 have been fully vaccinated. I wonder how many CDC employees are vaccinated?  CDC Director, Dr. Rochelle Walensky  

  Of course the government wants everyone vaccinated, but it should be an INFORMED decision preferably with a physician. Unfortunately the information changes by the week, and makes hesitant people even more concerned and confused. The evidence is overwhelming….get vaccinated, not because the government says so, but because the science does. Regarding the masks and mandates, the science is not yet there.

Biden and Facebook censorship

  I must comment on the administration now partnering with Facebook to determine what COVID misinformation should be deleted that might interfere with considering a vaccine. Since I have noted many times, there is always room for interpretation with medical data, and it can change month to month, do we want the government defining what is COVID misinformation or independent medical experts? Censorship by the government is danger business.

D. More on the Origin of COVID--Seattle scientist discovers deleted sequences of the COVID-19 virus in early December, 2019

  Why do we not hear anything from our government about the COVID-19 origin? This may explain it.

  Dr.Jesse Bloom, Professor at Fred Hutchinson Cancer Institute, University of Washington, Seattle, announced that he had discovered 13 deleted genetic sequences of the original COVID-19 virus in patients as early in December, 2019, in Wuhan, China. This was long before the viral outbreak was disclosed. Those deleted viral sequences disappeared from the online data base when published by Wuhan scientists.

  Dr. Bloom felt that the virus was circulating much earlier than was reported (long before the reports that there was an initial outbreak in a Wuhan seafood market linking it to bats).

  Deleting the sequencing of those viruses raises a serious question about the timing of the reported initial viral outbreak in Wuhan, and when and where it actually started in China.

  This information comes at a time when it was reported that Wuhan scientists asked the NIH (Nat’l Health Institute) to remove this particular research at a time when the world was about to experience the worst pandemic in over 100 years. Dr. Bloom who wrote the report suggested that the deletion of these sequences were done to “obscure their existence”. It is a fact that the Chinese Communist Party who run this lab lied to the world about it existence and that it was infectious.

  On July 22, 2021, the Communist Chinese Party officially stated they would not cooperate with the WHO (World Health Organization) investigating the origin and timing of the pandemic.

  Dr. Michael Worobey, evolutionary virologist at the University of Arizona, and not involved with this particular research, stated that this information “significantly advances efforts to understand the origin of the SARS-CoV-2”. (formal name of the COVID-19 virus)

  Drs. Bloom and Worobey are 2 of several U.S. researchers interested in calling for more research into how the pandemic began, as stated in the New York Times, June 23, 2021

  Dr. Bloom found that the samples studied were missing 241 sequences* in the coronavirus from a follow up report.

*sequences are the amino acids in the viral genome; these different sequences can make the original virus more infectious and virulent and is the basis of “gain of function research”.

  The viral samples were collected several weeks before  the outbreak occurred in December, 2019, according to Dr. Bloom.  He stated that, with his evidence, the virus had been circulating in Wuhan Province before the virus had reached the seafood market.

  There is clearly more work to be done to analyze the similarity of the original virus and the “gain of function” version, to better understand the origin of the virus. But without Chinese cooperation, where is this investigation going?? Without global economic sanctions on China, nothing will happen. Why is our administration silent? Meanwhile,  Dr. Woboley and his colleagues are using the 13 recovered sequences from Dr. Bloom that at least prove the virus was “doctored” in a lab and not from natural sources (bats).

  Dr. Bloom also stated that the Chinese Communist Party destroyed a number of early viral samples and barred any publication of papers on the coronavirus without its approval. They also lied about any possible laboratory leak, which is not an uncommon occurrence in labs unfortunately, and happened with the SARS virus as well.

  It is still not known the motivation for deleting these sequences and demands an explanation. Were they just covering up their carelessness in the lab or was their some other motivation?

   What creates a serious issue for the U.S. is that it is now known that the U.S. Government’s National Institute of Health (Institute of Allergies and Infectious disease-headed by Dr. Anthony Falci) was discovered to be  involved with the Wuhan Labs financially and scientifically.

  There is documented evidence that the U.S. invested 9 grants (starting in 2010) through an intermediary non-profit organization-- EcoHealth Alliance* to the coronavirus research Virology Institute of Wuhan . Dr. Fauci, head of that institute denied twice of any funding by the government to the Wuhan Institute of Virology in congressional meetings a few months ago and on July 20 as well. The world needs answers! But the Speaker of the House of Representatives refuses to create an a committee to investigate this pandemic’s origin. 

*EcoHealth Alliance organization, a non-profit organization

E. Kids back to school—mask guidelines just changed include all!

  Science supports children being able to go to school face to face. However, because the FDA does not recommend vaccination (yet) under the age of 12, the CDC changed its mind and now will require mask wearing for all children in all grades. Universities are already requiring them. Florida has declared them optional as other states have. However, with pressure from the delta variant cases rising, states may get pressured into mask mandates. Political pressure will fill the airways and newspapers.

The WHO advises against wearing masks below age 5, and minimally in those age 6-11, while the CDC recommends masks on all 2 and over.

  All variables considered, there is still no good clinical science about the benefits and risks of children wearing masks, no matter what “expert” says so.

  The CDC just published the latest guidelines on going back to school face to face with revisions. Here are some of the highlights:

1. In-person schooling is recommended and a high priority.

2. Promoting vaccination on eligible individuals is recommended.

3. Children age 2 and older should wear a mask while inside at school and crowded events outside when physical distancing (3 feet) cannot be maintained.

4. Every child, teacher, or maintenance person should stay home if symptomatic of any infectious disease. These individuals must notify the school regarding when it is safe to return.

5. COVID prevention strategies remain critical to the prevention, transmission, and outbreaks especially in areas of the country where transmission is high.

6. Members of the school administration and parents must keep lines of communincation open, and if a child is exposed at home, the school must be notified and proper isolation is a must.

7. Localities should monitor community transmission, outbreaks, local vaccination coverage, and screening testing need to be performed to guide adjustments in school guidelines.

8. Multiple forms of protection include the combination of masks, 3 foot physical distancing, proper room air ventilation, hand washing, coughing into the elbow, and washing surfaces. Plexiglass screens have proven of little value. Ventilation is very important to prevent aerosol spread. Screening tests at schools will be used, staying home when sick, getting tested when symptomatic, and contact tracing in combination with quarantining and isolation are all critical to controlling transmission.

  Buy-in of parents and students requires education and team work, but mandates will create great controversy.

  If you want want more information please log on to the CDC website for Guidance for COVID-19 for K-12 schools at www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-guidance.html

  The good news is that children transmit the virus very rarely (1% of the time), and if sick, are rarely hospitalized.

Clinical proof masks work?

  There has never been any clinical*study to prove masks prevent infection. There is only one clinical Scandanavian study published that has proven masks do not prevent infection comparing a large group of mask individuals vs unmasked individuals over 3 months. I have reported on this study previously.

*clinical studies use humans, not machines in labs may be valuable, but do not prove that in the real world masks work. The latest this week came from Mayo Clinic using mannequins to test the protection of masks from aerosol transmission. They can’t account for a major percentage of people wearing masks improperly or wearing a mask that is not protective. We need a standardization of masks if we are stuck with them.

  Medpage Today, July 9, 2021

F. Side effects from certain vaccines-Myocarditis, Guillain-Barre’ Syndrome

  Most of the known side effects occur with the second dose especially in young people and in those previously infected. There are studies to prove one dose is as effective as two.  Some countries only recommend one dose below 18, because the infection rate is low or those infected are primarily asymptomatic or have mild symptoms. Other countries don’t vaccinate below 18, while the CDC differs.

 Myocarditis caused by vaccine

  This myocardiopathy has been underdiagnosed as pointed out by some experts, but the CDC still feels that the good outweighs the potential harm regarding young people and accepting the small risk that has been reported (Moderna reported 323 cases 12-27, with most 12-17 in 12 million doses). Further there is no distinction made between those totally healthy, obese, and with other underlying health issues who had the side effect.

  Myocarditis occurs at a much higher rate as a complication in infected patients, thus allowing the CDC to decide the benefit far outweighs the risk. Yet, there is a package warning that myocarditis is a risk by the FDA.

  It is stated that younger people have such good immunity, when they are challenged with a second dose of vaccine, that the immune response goes overboard and causes the immune myocarditis. Taking only one dose prevents most of these cases (70-80% vs 94% with the second dose). Studies are still ongoing on this issue. Talk to your trusted doctor about this and other issues in deciding vaccination.

  In this report, I discuss myocarditis under the subject of myocardiopathy later in this report.

Guillain-Barre’ Syndrome caused by vaccine

  Johnson and Johnson (J&J) vaccine reported 100 cases of Guillain-Barre’ Syndrome, a neurologic paralysis that can be permanent, although the company notes almost all have recovered. This is in the face of 12.5 million doses given. This is a demyelinating polyneuropathy usually starting in the lower legs with weakness, numbness and tingling. This side effect has not been reported by other vaccines. The FDA plans on stating it is a possible side effect of the J&J vaccine. Medscape Medical News, july 12, 2021. This is not reported by other vaccines.

G. Newer combined medications reduce mortality in more severe cases and may prevent symptoms

  The treatment of severe cases of COVID-19 has improved with further studies using combination medications including the known medications such as corticosteroids, tocilizumab (a monoclonal antibody), antivirals, supportive care, convalescent serum, and now Regeneron.

  Regeneron, an antiviral monoclonal antibody produced in the lab, has reduced the severity of early hospitalized patient, but not in many severe cases. Now a study has reported good response in severe cases as well.

Regeneron contains casirivmab and imdevimab, both monoclonal antibodies. The combo binds to two different sites on the coronavirus spike protein neutralizing the ability of the virus to infect cells. Regeneron is an  intravenous infusion reducing chances of dying by 20% in more severe cases, shortening hospital stay, and reduces the need for mechanical ventilation.

  This week a study was reported that Regeneron is preventing disease progression on those who have been just exposed. So now it is a treatment for early and late cases, and now a preventative prior to a positive COVID-19 test.

  Patients with already high levels of antibody (using testing) from the infection will not improve mortality rates, but is reserved for those who can’t generate a good antibody response.

  Those most likely to have a less robust antibody response are those that are older, have serious underlying disease, and are extremely overweight. These are the patients who respond better with Regeneron.

  This study on combination therapy reported dropping the mortality rate from 36% to 24%, a much better rate than early in the pandemic, when these meds were not even being used, and the treatment was mainly supportive. Now we have better ammunition.

Medscape News, June 16, 2021  

H. Issues that play a role in deciding to be vaccinated

Here are some of the issues:

  -There continues to be uncertainty about vaccine necessity for children under 12 and currently is not recommended but being studied (should be cleared for vaccination in the fall).

  -There has been great concern about fertility after vaccination. Female studies have proven no evidence of decreased fertility in the first year. Now a small study on men found no change in character, amount, number of sperm, motility, etc. 70 days after vaccination. These are short periods and clearly need longer term studies. JAMA, July 17, 2021

  -Pregnant women are quite hesitant but there is no proof the vaccine causes any neonatal issues. Long term effects are not known.

  -There is some evidence that younger people may not need 2 doses of vaccine, yet to be proved.

  -There are those who have been infected with the virus and have natural immunity, and question whether a vaccine is necessary. There is also a study published on June 25, 2021 in the Journal Science that reported a 100 fold increase in antibody levels (T and B cell antibody, and 10 fold increase in memory B cells) if vaccinated after being infected. The level of circulating antibodies has not been dertemined what is required for prevention.

  -There are some who have a significant reaction to the first dose and decide not to receive the second dose.

  -There are those who were extremely ill from COVID and still have not recovered completely or have the prolonged syndrome, who aren’t strong enough for the vaccine.

  -There are those who are immunosuppressed from illness and disorders and can’t adequately respond to the vaccine (and it has been suggested that they even need a booster).

  -Politics have, as usual, has stuck its ugly face in this issue. Some feel it is patriotic to get vaccinated and others feel since this is a free country, and they have the right to decide for themselves whether they and their families should get vaccinated. Some just don’t trust the government or do not want them mandating a vaccine.

  -There are the Antivaxxers (24%) that refuse all vaccines, and further spread mistrust and misinformation throughout the country. They are responsible for most of the misinformation about COVID on the internet (a microchip is in the shot, it could make one sterile, gives a person the infection, etc.).

  -Younger people have the highest rate of not getting vaccinated, because they think they are very likely to not to get infected or have an asymptomatic or mild case. To many of them, that is safer than risk a side effect of a vaccine.

  - Some minorities are easily convinced that the vaccine is unnecessary, or that only one dose is necessary, or that since they became symptomatic with COVID-like symptoms, they are already protected. There also could be a significant number who were infected and never came forward, got tested, and were not counted.

  -We still don’t know how long the immunity will last (most likely a year), and if a future dose might be recommended, it will be even harder to convince individuals to get vaccinated. Boosters are being studied as well.

  -Because of the emergency use approval of the vaccine, there are those who feel and have wrongly been told that the vaccine makers skipped safety steps by antivxxers. That is categorically false. But the vaccine still officially has not been approved, which has created hesitancy. By Fall, I hope that will change with formal FDA approval.

  -A large number of people have no primary care doctor, and have no trusted source to reach out to, giving individuals the confidence to be vaccinated. In fact, if doctors had the vaccine in their offices, more would get the vaccine. In these cases, it is important to trust a pharmacist to help individuals make the decision.

  -One of the biggest reasons for vaccine hesitancy is lack of good credible consistent health knowledge without mixed messages and different guidelines changing weekly. I think if doctors were supplied with the vaccine in their offices, more would be likely to accept a vaccine.

  -Certain communities (especially rural) need more outreach programs to make the vaccine more easily accessible (mobile blood centers). Black and Hispanics are less likely to get vaccinated partly because of this issue.

  -Physicians and other healthcare professionals need to be better advocates for the vaccine, as close to 90% have been vaccinated, but other healthcare workers have some of the highest rates (30-40%) of “wait and see”. Even over 25% of CDC employees have not been vaccinated.

  -20-30% of people are not against the vaccine, they just are not going to get a vaccine because the government says to. 12% are wait and seers.

  -The delta variant rise in cases may motivate some hesitant individuals. Fear works….sadly!

Medpage, June 29, 2021

2. Cardiomyopathy—see next page

The anatomy of the heart consists blood (coronary) vessels, 4 heart valves, and the heart muscle . The most common disease affects the heart’s blood vessels, the coronary arteries, created by atherosclerosis (hardening of the arteries). Valvular diseases cause serious problems as well and have different causes, while diseases can also affect the heart muscle—termed cardiomyopathy.

  Symptoms include chest pain, shortness of breath, dizziness, palpitations, etc. regardless of type of cardiomyopathy.   

  Types of cardiomyopathy include hypertrophic,  arrhythmogenic (heart irregularities), dilated and restrictive (scarring) caused by certain medical diseases, and the symptoms are similar depending on the pathology of disease. The symptoms, complications, and workup are similar for all of these types. The key is to finding the underlying cause(s).

  Causes of cardiomyopathy include genetic, infectious, autoimmune (i.e.lupus), coronary disease and heart attacks, various diseases that damage the heart muscle, endocrine diseases such as thyroid or diabetes, substance abuse including alcohol, and muscle conditions such as muscular dystrophy, and pregnancy.

Hypertrophic cardiomyopathy

  This genetic disease creates thickening of the heart muscle especially the ventricular septum (partition between the heart chambers), as seen in the drawing below. This condition makes the entire heart muscle work harder and the heart enlarges and can go into heart failure, cause heart irregularities, and cause the heart valves to malfunction as well.

A thickened heart muscle makes it harder for the heart to pump blood. Often without symptoms, the diagnosis goes for years until the process has worsened, with shortness of breath and chest discomfort.

First degree relatives need to be tested for genetic markers.

This is usually a genetic disease, and families must alert their relatives.

Arrhythmogenic cardiomyopathy (heart beat irregularities causng heart damage)

This type is also usually genetic in cause affecting 1 in 5000 people, although all of these cardiomyopathies can cause heartbeat irregularities. This genetic type causes deposition of scar and fat leading to deterioration of heart muscle function. This usally becomes clinically apparent in adolescence in 50% of the time.

Dilated cardiomyopathy

Note the thinning of the heart wall from a dilated heart.

This rarer type can occur at any age but usually age 20-40s is most common. This type leads to heart failure because a dilated thinner heart muscle can’t pump adequate blood around the body, but also heart irregularities (arryhthymias), blood clots, and sudden death. Although this also can be inherited and run in families, there are many medical causes such as diabetes, obesity, arrhthymias, hypertension, substance abuse, and certain infections.

Restrictive cardiomyopathy

  This is the rarest pure form of cardiomyopathy, and the most common cause is not discoverable, but there are certain diseases that can cause scarring and diminished heart function such as amyloidosis, sarcoidosis, chemotherapy or radiation to the chest.

  This can be confused with constrictive pericarditits, which is the covering of the heart that can be inflamed or infected from many of the same causes that occur in myocarditits.

  If this is not improved over time, a heart transplant may be the only option.

Complications of any cardiomyopathy

  This includes atrial fibrillation, heart failure, valvular insufficiency, and possible cardiac death.

Key points:

  1) echocardiography is central to defining the severity, which may demonstrate left ventricular outflow obstruction, mitral regurgitation, and left ventricular ejection fraction abnormalities. This needs to be repeated every 1-2 years when clinical symptoms dictate.

  2) Cardiac MRI can be performed when the ECHO is inadequate.

  3) Exercising tests are valuable to assess the potential for using advanced heart failure treatments.

  4) An implantable cardioverter-defibrillator in those with sustained arrhythmias are recommended.

  5) Initial treatment includes beta blockers or calcium channel blockers, and diuretics. Surgery may be recommended in refractory cases.

  6) If atrial fibrillation is present, oral anticoagulants are recommended to prevent clots forming in the atria of the heart and embolizing to the body and brain.

  7) Mild to moderate exercise is recommended in most cases and is beneficial.

  9) Myocardial infarction without coronary obstruction can occur in 15% of cases, and cardiomyopathy is one of the causes.

 10) An extensive search for an underlying cause is in order.

J. American College of Cardiology, Nov. 20, 2020

COVID-19 Vaccine can cause myocarditis

  Myocarditis and pericarditis be a side effect of the COVID-19 vaccine or the disease (more common with infection). It is usually mild and the symptoms are mild, with recovery expected and affects usually male age 16-30. It usually occurs a few days after the vaccine is administered.

  Pfizer Pharmaceuticals report it occurs 12 times for every million doses of vaccine, but much more often if infected by COVID-19. The CDC continues to recommend the vaccine for everyone 12 and older.

  Viruses are the most common cause of myocarditis especially in children.

  It can be more severe from other causes such as Staph and Strept bacteria, gastrointestinal infections, and rubella (German measles). Lyme disease, autoimmune causes such as lupus, sarcoid, amylodosis, and other viral causes must be looked for. Fungal and parasite disease can also cause this cardiomyopathy.

  The inflammation can cause interference with the electrical system of the heart (arrhythmias)

  Chemical exposure, carbon monoxide, radiation treatments for the chest (and breast), and a host of medications including antibiotics all are causes.

Mayo Clinic, CDC, The American Heart Association

NIH

3. Changes in recommendations for the use of medication inhalers for mild to moderate asthma

The mainstay of asthmatic treatment for people 12 years or older has been the use of inhalers containing corticosteroids for inflammation combined with a bronchodilator for muscle relaxation of the lungs smaller tubes called bronchioles, keeping the airway open allowing normal aeration and oxygenation through the lungs.

  Corticosteroids (budenoside, fluticasone, etc.) used along with beta 2 agonists are the standard treatment and other medications can becombined as needed.

  There are 2 types of smooth muscle relaxation in the bronchioles to bronchodilate—beta-2 agonist and muscarinic antagonists:

   1- Beta 2 agonists* stimulate the beta cells in the smooth muscles of the bronchioles and provide quick relief of wheezing.

*beta agonists examples are formoterol (Perfororomist, Foradil), albuterol (Ventolin), Maxan, Brethaire, Bronkosol, and Xopenex

   2- Muscarinic antagonists* also relax smooth muscle, but by a different mechanism…it is an anticholergic drug blocking the neuromuscular junction where acetylcholine acts on smooth muscles, glands, and cardiac cells.

*muscarinic antagonists examples:  Spiriva, Ellipta, Tudorza, and Atrovent

Some of these products come in powder form to better adhere to the lining of the airway, however, it can cause irritation of the airway and a liquid form can be prescribed (i.e. Symbicort).

  Recent research has allowed for some changes in the treatment regimen depending on the circumstances and response from the medications. As always guidance or recommendations are nothing more…..they are not fast and hard rules.

Children may do better with mask and nebulizer (above)

  The 2020 National Asthma Education and Prevention Program has made these changes, having revised their 2007 recommendations.

  Asthma therapy is based on whether the asthma is intermittent or persistent asthma,  mild, moderate, or severe. For those 12 years and older, no drug changes have been recommended for intermittent asthmatics, however, there are some changes for varying degrees of persistent asthma.

  1- Intermittent asthma--they still recommend as needed short acting beta-2 agonists* as a rescue therapy.

  2- Mild persistent attacks—2 choices—a) daily low dose corticosteroid inhaler plus as-needed beta-2 agonist or as needed combination of these 2 medications.

  3- Moderate persistent asthma--Formoterol—low dose in combination with a beta-2 agonist.

  4- Worsening asthma—a medium dose corticosteroid with formoterol. Adding a long acting muscarinic antagonists is recommended if the steroid is unsuccessful by itself.

  5- Fractional exhaled nitric acid testing is also recommended to measure the level of nitric acid in the exhaled air, and is used if the diagnosis is in question.

  Nitric acid is released by the body to fight inflammation and relax tight smooth muscles present in the bronchioles that constrict with asthma. High levels in the exhaled breath means there is inflammation present in the airway. The test can be also used to determine the progress of asthma treatment.

Nitric acid testing

6- Allergy evaluation (immunotherapy)—recommended to see an allergist for those symptomatic.  Allergy shots are now recommended over sublingual meds. Shots are recommended in addition to standard allergy oral medications (antihistamines).

7- Indoor allergy mitigation—strict house cleaning, removal of cotton drapes and bedding, rugs, no feather pillows, keep windows closed, no animals, monitor foods, HEPA filters, no smoking in the house, etc.

Signs there is an underlying asthmatic condition going on include shortness of breath, tightness in the chest, or cough.

Asthma inhalers for COVID-19 patients with pulmonary symptoms

  Bronchospasm can occur with any pulmonary condition. In patients with and without asthma, the use of steroid medihalers. An example is being prescribed for patients with COVID-19 having any pulmonary symptoms, as soon as symptoms begin, but also after intravenous corticosteroids are used. For patients who remain outpatient, there may be a role if any pulmonary symptoms occur. Of course, the use of these medihalers with and without bronchodilators must be discussed with the treating doctor. This was discussed by three pulmonary specialists on Medscape, an internet medical journal on December 22, 2020.

  These same medihalers are prescribed for patients with chronic types of lung disease especially COPD (chronic obstructive pulmonary disease).

4. New Guidelines for treating gout

Gout is a form of arthritis, and can be diagnosed with testing for an elevation of uric acid in the blood. Clinical signs and symptoms of pain, swelling, and with redness of extremity joints especially the classic big toe (podagra).

  Uric acid is the final product of the breakdown of an amino acid purine (actually guanine and adenine). Foods (organ meats, alcohol, seafood, and sweetened beverages) high in purines can create an acute attack of gout, kidney stones, and joint damage. They must be avoided in the diet.

  3% of adults suffer from gout. In one study from Minnesota (J. Rheumatolgy, April, 2018) the authors found high rates of comorbidities (hypertension-69%, type 2 diabetes-25%, renal disease-28%, elevated cholesterol-61%, and obesity-29%). The incidence has doubled over the last 20 years thought primarily because of the rapid increase in Americans being increasingly overweight or obese.

  Gouty arthritis is the most common inflammatory form of arthritis. It is caused by the deposition of urate crystals in the joints causing severe pain in acute stages, destruction of joints over time (podagra is the classic big toe inflammation seen in the above photo), damage to the kidneys from deposition of crystals, and kidney stones and renal failure evetnually.  

   Elevation of uric acid can occur without joint or kidney symptoms (stones), but if elevated and is correlated with joints issues, a diagnosis of gout can be made. The diagnosis is made clinically with a blood test for uric acid levels. Gout is more common in males with different normal values men-4.0-8.5mg/ml; women-2.7-7.3mg/ml

  Treating asymptomatic elevation of uric acid has been controversial for some time. Studies have disproven the value of treating elevated levels with uric acid lowering drugs such as allopurinol to prevent kidney damage  NEJM-Internal Medicine, July 15, 2020

  Deposit of uric acid crystals under the skin create skin nodules (tophi). Hand left and ear right!

There are new guidelines put out by the American College of Rheumatolgy as reported in the NEJM. Included in the new guidelines are for symptomatic uric acid elevation as follows—uric acid lowering meds should be prescribed for anyone who has more than 2 acute gouty attacks per year or tophi as demonstrated in this Xray.  

However, if there is an elevation of the uric acid over 9mg/dl with at least one attack, they conditionally recommend allopurinol, 100-300mg daily up to 800mg daily. Allopurinol will not treat an acute attacks.

  Also individuals with acute attacks can choose 750 mg of naproxen (Aleve) initially followed by 250 mg. three times a day for 4 days in addition to allopurinol. Otherwise, colchicine is required.

  Traditionally, colchicine has been used for gouty attacks, however, it is extremely irritating to the stomach. Recent studies have found that naproxen is as effective as colchicine in relieving pain and inflammation. Naprosyn can be prescribed as well.

  Corticosteroids are also recommended with either drug regimen. 2/3 of the patients were pain free in 7 days based on studies.

  Podagra (classic big toe inflamed joint) is as painful as any pain that can be endured. Other extremity joints can be involved as well including ankles, knees, elbows, wrists and of course fingers and toes.

  There is a disease called pseudogout, which can be indistinguishable from gout, except the crystals deposited in the joints and soft tissue are calcium pyrophosphate. Examining joint fluid will distinguish the uric acid from the calcium crystals in the joint fluid.

  The risk factors for gout are included in the metabolic syndrome, which are hypertension, elevated blood sugar, overweight especially abdominal fat, elevated cholesterol (or triglceride), all of which raise the risk for heart attack and stroke.

The risk factors for gout also include:

1) diet rich in meat, seafood, and alcohol especially beer.

2) obesity

3) family history of gout

4) Recent mental or physical trauma

5) Certain medications including diuretics, aspirin, levodopa, cyclosporine, niacin, etc.

6) Medical conditions—untreated hypertension, heart disease, diabetes, or kidney disease

  This disease is not curable, and can only be controlled without further damage to the joints and kidneys with proper diet with prevention of high purine foods.

  Clearly, attention to a proper diet, management of medical conditions, and using medications for symptoms and acute attacks plus uric acid lowering agents such as allopurinol will reduce symptoms and number of attacks.

  WebMD; NIH;

5. New medication for daytime drowsiness--Sunosi oral medication   

  The ads have begun on a new medication actually designed for narcolepsy, but the market is clearly focusing on a much larger group--in people with obstructive sleep apnea. 28% of adults suffer from some daytime drowsiness primarily from lack of sleep, sedatives, narcolepsy, and obstructive sleep apnea.

  I have reported and discussed this subject numerous times, and the main symptom of apnea patients is daytime drowsiness, due to low oxygen levels every time an episode occurs during sleep (the average number can be from 20-40+ episodes per hour).

  An apneic episode is defined as breathing obstruction from airway blockage for 10 seconds or more. Mild (4-10 per hour), moderate (11-38), and severe 39 or greater).

The physiologic effects of apnea are quite serious and must be diagnosed and treated. Most people are over weight, have shorter necks, small airways from jaw abnormalities, and snore loudly. Most of these people are sleeping alone, because of loud snoring mixed with what sounds like breath holding. 

  Having performed hundreds of surgeries on those people who can’t tolerate CPAP or dental prostheses, I can assure the reader apnea is a medical disaster waiting to happen. Please read my previous extensive reports on this syndrome, by looking at special reports in the subject index and also in alphabetical order under apnea. www.themedicalnewsreport.com

  Because narcolepsy is another separate brain disorder characterized by sudden episodes of extreme drowsiness and even falling asleep, there are several stimulants that improve their symptoms. But these medications are often abused (Adderal, Provigil, Nuvigil, Moddafinil, armodafinil, and Ritalin). The newer drugs cause less stimulation of the person with less raising of the blood pressure, excitability, irritability, etc., but are often abused by truck drivers, and others who demand total alertness, etc.

  Now a new drug is being marketed, Sunosi. The generic drug is solriamfetol, and is meant to be used for narcolepsy, but due to the fact that those with sleep apnea are drowsy during the day, they are marketing it off label and physicians are being asked to prescribe it. There are no studies regarding effectiveness, but it in no way helps apnea at night.

  Sunosi is the first dopamine/norepinephrine reuptake inhibitor (so are most antidepressants), and one must discuss the wisdom of going on essentially an anti-depressant, especially if one is already taking one.

  The initial reviews are terrible with only 21% reporting a positive effect even in narcolepsy. A report in Medscape had different findings. and reports from a sleep specialist, Dr. Atul Malhotra (could have ties to the drug company) cited a legitimate randomized double blind 12 week study in the Journal of Respiratory and Critical Care Medicine, Dec. 8, 2018.

These authors reported 89% of those with sleep apnea had a significant improvement in daytime drowsiness compared to 49% of the placebo group, which in my opinion is masking an underlying disease. In another small study of narcolepsy patients, 78% were improved compared to 40% of placebo. These improvements are subjective, since there is no way to measure drowsiness.

  I would like to see more studies to prove the value of these drugs due to the potential addictive nature of any stimulant. These studies took the word of the participants making it less than perfect and only observational.

  Like many antidepressants, it affects the dopamine and norepinephrine neurochemicals, but it in no way treats the underlying cause of obstructive sleep apnea due to airway anatomical abnormalities.

Side effects are many

  All narcolepsy medications are dangerous for people who have hypertension, heart disease, kidney problems, diabetes, and mental disorders. MAO inhibitors must not be taken as they will cause a hypertensive crisis in the face of this and many narcolepsy medications.

   All these medications act similar to benzadrine and amphetamines.  These above named diseases are extremely common in patients in patients with obstructive sleep apnea, and deserve a sleep study in a certified sleep laboratory and proper medical and airway evaluation for evidence of nasal and oral potential abnormalities.

  Sunosi cost $700 for 30 pills, and makes it one of the most expensive products for narcolepsy. It is only available as a brand name prescription. I do not know if it would be covered by insurance for sleep apnea patients.

  The reader must discuss any abnormal drowsiness issues with their physician to rule out narcolepsy, obstructive sleep apnea, or other rarer causes with a legitimate sleep issues.  Trying to cover up an underlying medical problem is dangerous business. All of these drugs are habit forming and must be monitored carefully.

  The FDA recommends only 1 dose per day and before 9 hours of sleep.

  Sunosi is also a Schedule IV controlled substance and can easily be abused, even more than diet pills such as phenteramine.  

WebMD, Medscape, www.medicalnewstoday.com

6. The polypill

For years, scientists have been experimenting on pills to give to a population of people to slow down the incidence of cardiovascular disease and the mortality rate in those who have already been diagnosed. It is really more of a global attempt to provide a cheap pill to curb disease. It has been a noble attempt, but proving the value of such a treatment in a diverse group of humans is really challenging.

  Recently, there have been a few published papers regarding the “polypill” directed at those 55 and older diagnosed with some type of cardiovascular disease (hypertension, coronary disease, cardiomyopathy, heart failure, TIA or stroke).

  Cardiovascular disease accounts for 18 million deaths each year worldwide. It is more prevalent in poorly developed countries. It would be quite advantageous for a solitary pill to be admininstered to huge populations to reduce disease burden if really effective in reducing morbidity and mortality.

  The polypill consists of:

 One baby aspirin (81mg), 20mg of atorvastatin, 12.5mg hydrochlorothiazide (a water pill and antihypertensive), and either valsartin 40 mg. or 5mg of enalapril (treats blood pressure and improves heart muscle function). Other studies used similar but slightly different medications (atenolol, simivastatin, and vitamin D).

  In 2003, a publication proposed the use of a fixed dose combination pill and stated that it could reduce the disease burden by 80%. However, studies today have not been able to come close to that figure. Yet, international studies are reporting 30-34% reduction, a sizable number as in these studies.

  The reduction of blood pressure (drop of 6mm), LDL-cholesterol (drop of 20mg/dl) was significant and were thought to be the reason for reducing cardiovascular events in those who stayed on the regimen for the required 4-5 years; pretty amazing that just a small reduction in these factors can make a difference. Encouraging!

  Although there was a slight increase in the number of polypill participants with side effects (dizziness, hypotension) 2.7% vs 1.1% placebo, it was still quite small. Aspirin with the polypill also demonstrated better reductions in cardiovascular events.

  Physicians are trained to treat signs and symptoms individually, and for physicians in this country, it could be a stretch, and the polypill is not widely available around the world and the USA, but it does keep the dialogue going to globally reduce cardiovascular disease burden.

  For now, it is clear that people with known cardiovascular disease need to manage their blood pressure, cholesterol (and triglycerides), and other signs and symptoms of cardiovascular disease.

  If using a polypill can reduce the number of cardiovascular events by 30%, imagine how effective it would be to adequately address the other elephants in the room.

  Weight continues to be an enormous problem driving this disease, and until the medical profession (and the public) are serious about maintaining a healthy weight, eating a healthy balanced diet, stop smoking, reducing the amount of alcohol intake, and manage other co-morbidities, especially diabetes, we are just putting a bandaid on the problem, when prevention will always be the key. NEJM, Jan 21, 2021 (Canadian study)

This completes the August, 2021 report:

Enjoy your summer, and stay healthy and well, my friends, Dr. Sam

The subjects for September, 2021:

1. COVID-19 udates

2. Updates in cancer

3. Pregnancy Issues affecting health-early and late

4. Updates in Diabetes

5. Diverticular disease

6. NSAIDs may be ok for older people (Aleve, ibuprofen, etc.)

Stay healthy and well, my friends, Dr. Sam