The Medical News Report
October, 2021, #117
Samuel J LaMonte,M.D., FACS
Welcome to Fall!
Subjects for October, 2021:
The autumn leaves
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.
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) 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 expect more out of them. Always write down your questions before going for a visit.
Thank you, Dr. Sam
10 major points
a- The pandemic has killed 684,000 people in the U.S. with over 42 million cases, and is being touted as deadly as the Flu epidemic of 1918. However, the Spanish flu occurred when our country was ¼ the size it is now.
If those previously infected and asymptomatic individuals without tests proving it, you could easily add another 8 million, therefore, I would accept 50 million cases.
We are close to getting on top of this virus, and the delta variant is expected to peak shortly and as unvaccinated people get the shot, we continue to get closer to universal herd immunity. 178 million Americans have been fully vaccinated, as of September, 2021.
This pandemic will go down as one of the worst health crises ever, and it could have been prevented if only the Chinese Communist Party would have been honest from the beginning allowing their Wuhan scientists to announce the outbreak as early as December, 2019. More information continues to be exposed.
b- The FDA has chosen not to approve the Pfizer booster (brand name Comirnaty) for the general population, only those over 65 and those at high risk for a severe illness regardless of age above 18 (not 12). The brand name is approved for initial vaccination 16 and above. Why the difference in age? 16 vs 18?? If the old emergency use vaccine is used it is available 12 and older. AND THE PUBLIC WONDERS WHY WE ARE CONFUSED!
This authorization doesn’t include Moderna and J&J yet, as these vaccines are not fully FDA approved.
Can the vaccines be mixed? The CDC has no research on the answer, but other countries in short supply have mixed and matched from the beginning, with no reports of added harm. Check with your pharmacy!
Being at higher risk is very ambiguous, and has led the CDC to override their own committee that did not approve the booster for healthcare providers, first responders, and teachers, because the science did not support it. Once again, the government has gone against the science. These special groups are at higher risk but not necessarily for severe disease. So another mixed message. For the CDC to override their own expert vaccine committee because of White House pressure is pointing to a common theme from them….they do what they want.
Certainly anyone eligible with an underlying serious illness should get vaccinated when their time comes (6 months after last dose of Pfizer), and in fact, those truly immunocompromised are being considered even sooner, based on the physician’s decision.
Even a booster is only mildly effective in raising the antibody titers in a study on kidney transplant patients. I hope those people are super cautious about venturing out for now. JAMA Network, August 23, 2021
The pharmacy seems to determine the eligibility. There is no mention of a doctor’s note to receive the booster.
6 months from the last dose is approved by the FDA, while most of the research quoted 8 months as the best timing to get the booster. Thank God for Israeli studies, as our country’s research has been lacking in this area.
c- As we get further into this pandemic, research is creating as many questions as answers. Following the science has become a matter of choice based on the needs of the governing bodies. The White House announced boosters would be available Sept. 13, when the FDA hadn’t even decided whether to approve the booster for anyone.
d- For those who want to hear from the former FDA Commissioner until 2019, how poor our response has been to the pandemic and gross lack of preparedness for decades, read Dr. Scott Gottlieb, MD. Book titled “Uncontrolled Spread”. Most importantly, the information for future crises is well thought out, and will become a leading discussion in the near future.
e- As vaccines are being pressured on millions of Americans through mandates, those who choose to want more answers are not going to follow the “Pied Piper”. Yet, thankfully, more unvaccinated individuals are choosing to be vaccinated (now 64% of eligible residents). Mandates don’t change vaccine hesitancy, education does!!
A new concept and perhaps more inclusive and acceptable to the public rather than requiring proof of a vaccine, would be to require proof of immunity!!
Antibody tests would have to be performed and are not necessarily insurance covered, but it would include those who were infected, and vaccines ignore this major section of the population plus those who do not get a good immune response from the vaccines (even after 3 doses in some immunocompromised. Medpage Today, 2021, September 20, 2021
Those who have had the COVID infection continue to be ignored since many experts feel their immunity is quite good (will be explained later in the report). However, there is now more scientific clarity to the effectiveness of the vaccines and even the possible advantage of a booster in the medical literature just this month. However the strength of the dose is still under investigation. Children are clearly not needing an adult dose, possibly ¼ dose.
JAMA, August 30, 2021
f- We still do not know what level of immunity is adequate to prevent hospitalization and death. We still don’t have a cheap simple antibody test that can tell whether an individual is safe. We still are questioning if a person can carry the virus in their nose and be COVID test negative.
Pfizer has announced that their half dose vaccine is effective on 5-11 year olds. They will be seeking FDA approval very soon.
g- The B and T cell lymphocytes ( a type of white blood cell) are the main stay of the immune response against infection.
We also know that neutralizing antibodies are responsible for creating the vaccine immunity against the COVID virus. This is produced by B-cell lymphocytes. If a person is infected with COVID-19, T-cell immunity kills off infected cells limiting the extent of the infection. That is why the CDC recommends masks, because without the vaccine, there is not a lot of neutralizing antibodies to fight the infection, while the T-cells only limit the infection, therefore, we need both our body’s defenses and the added protection of the vaccine. But given an overwhelming amount of viral load in even a vaccinated individual, there will be breakthrough infection, albeit usually mild. Unvaccinated people are totally vulnerable unless they had the infection.
There are suggestions that it is more of people’s behavior rather than a waning immunity level that may cause breakthrough infections.
Israel has the best research and sadly, little is coming from our U.S. academicians this year. Masks are being used as if they are some panacea for protection without scientific clinical support except for surgical masks and N-95 masks. Clearly, it is the addition of other protective methods that give a decent chance of protection.
Those who have chosen to be unvaccinated are being shamed by the administration and many of their loyal followers are piling on, while 200,000+illegals per month are crossing our border with 15-20% infected and close to 100% unvaccinated. You can add over 100,000 Afghans to the list. They are filling the beds of some state’s hospitals, certainly in Texas and increases the number of cases which is being criticized by the Whit House. Where are the mandates for them??
h- Mandates will get a significant number vaccinated if backed by businesses (which is legal), but should include those coming to our country legally or illegally.
It has been clear for some time that vaccines work and everyone possible should be vaccinated, but shaming and bullying hasn’t worked. Now, we have mandates, which create more dissention. We must somehow get this virus under control, and now with the delta variant, there is more pressure on our country to reach for more stringent rules, even though it should still follow scientific proof that it works, otherwise, it just appears as the federal government is essentially signally their desire to create an authoritarian country than one of democracy.
We have not mandated vaccines since small pox in 1898-1904 outbreak, when people were literally dragged out of their house and police held them down to be vaccinated.
It wasn’t until 1972 that mandated vaccination was stopped in the U.S. Smallpox killed a high percentage, while even though the COVID-19 is highly transmittable (contagious), it is not very lethal. Don’t be surprised that mandated vaccines are coming again for the future.
About the only thing we all can agree on is wanting to get America back on its feet, control the virus, get people to work (most who are still at home has lost the zest for working),and try and enjoy this beautiful country we live in. I hope and pray we can!
i- Most experts feel COVID-19 will become just another influenza issue, needing possible boosters at unknown intervals. There is still a lot unknown. Even though the Pfizer vaccine (brand name—Comirnaty, experts warn not to vaccinate anyone under 12 years of age, as they will need a smaller dose when it is FDA approved and it is not approved.
Most experts admit that all humans will be exposed to COVID-19 eventually, and we will either have an asymptomatic, mild, moderate, or severe infection. COVID-19 will become endemic*. Meeting this virus one time or another should mean we need to be as protected as we can, which includes vaccination. Once we all come to grips with this, the world and its restrictions will be changed including governmental over-controls, and we can get on with our lives. That is not to say, we need to be careless or stupid. This virus will become endemic for the forseeable future, returning as influenza and many other viruses do in certain areas and certain times. Travel is always a culprit in infectious diseases.
You can hide but you can’t run….. Your behavior will determine how you deal with this virus.
j- Imervectin is not approved by the FDA for COVID-19
For the last time, imervectin is not approved for COVID-19 prevention or treatment, only for certain skin diseases (rosacea, etc.) head lice, and parasitic infestation in animals, and parasitic worms in humans.
There is no dose known even if an individual was willing to try it. There are multiple reports from the FDA for hospitalizations from side effects and overdoses, therefore, once again, follow the science (clinical trials show no value) and stay away from imervectin. www.fda.org
Also don’t forget to protect yourself from the flu, shingles, pneumonia, etc. with vaccines, especially those over 65 and vulnerable. MedPage Today, September 22, 2021
2- Mask effectiveness study! Wear the right one!
The CDC still recommends those over 2 years to wear a mask inside. A non-peer reviewed and poorly controlled study is being touted as the study that finally proves masks prevent infection, from Bangledesh!
Only surgical masks (similar to N-95) were effective in reducing the number of symptomatic test positive volunteers from various villages in a third world country, however, only by 9.3%.
3 layer cloth masks were also compared in half the study, while surgical masks were used in the other half; controls wore no mask. Only 9.3% fewer symptomatic infections occurred in those with surgical masks and only half of that percentage in 3 ply cloth masks. The study lasted only 8 weeks. The masks passed out were free, and it is not known if they changed their masks daily or where they wore them.
The number of volunteers wearing the masks properly (tight fitting, nose in, etc.) was only 20% of the sample, as witnessed by the study staff. There was extensive education for all volunteers including adding 5 feet social distancing, even in mosques.
They also were not able to test asymptomatic people and only 1/3 of the participants volunteered to have blood tests to prove antibody response from the infection. PCR nasal swab tests were used (60-70% effectiveness) to prove infection.
This study found that only fewer infections occurred in older people (50-60 years old) wearing surgical masks, since typically younger people rarely wear their mask properly and are not as compliant or consistent. This implies that younger people, in any country, won’t be helped much by masks, even surgical masks. Just look around you, and see how many noses are sticking out of their masks, mostly employees.
People older than 60 who were wearing surgical masks had the best results--35% reduction in cases, pointing to older people having more at stake with infections and more motivated to wear masks properly and at all times when necessary.
The CDC does not recommend the general public wear N-95 or other surgical masks, but wear 3 ply cloth masks as the surgical masks and N-95 masks are in short supply.
Since I have been to stores where masks are not mandatory, it is amazing how friendly those without masks are. Our socialization has suffered greatly with this pandemic. Children are suffering much more, and have lost the understanding of facial expression as a form of communication. Think about lip readers and their suffering.
The CDC has this drawing below on their website:
Multiple layers of different protective methods (not just masks) are necessary for potential prevention of transmission or contraction of infection.
Proper masks, social distancing, proper ventilation, avoiding large groups, and compulsive hygiene are necessary to have any chance of prevention. And no matter which mask is chosen, whether valuable or not, it must fit tightly on the face and cover both nose and mouth. If a man wears a beard, he is not protected at all and is transmitting the virus!!!
Do not wear the same mask for days, as people often do. You breathing bacteria and fungus growing on the mask. Wash the cloth masks often and replace any other type daily. Where is the research on an effective mask that is standardized for the public? Masks have become less about public health and more of a political statement, sadly.
Read the study for yourself found in the editoral section in Medscape, September 3, 2021, by Masters level reporter Brenda Goodman, MA.
I have also cited in previous updates, the only clinical study performed in the medical literature (Scandanavian) that was published in the European journal, Lancet, and found no difference in mask (masks were cloth) wearing regarding the rate of infection over a three month period (300 in study with and without masks). Of course, trying to maintain surveillance over people’s willingness to properly wear a mask every time they went out of the house is only one of several limiting factors in any study which human behavior is hard to control.
Another study found that ¾ of people with COVID-like symptoms test negative for COVID-19. And trying to study people in different parts of the U.S. (much less a third world country such as Bangledesh) will likely provide different results. This article makes it very clear that providing mixed messages regarding masks does not get good results.
If the federal government had performed adequate studies (outside a lab in real people) on masks early in the pandemic, we would not making it so controversial. Where is the message that cloth and paper masks don’t work??? The CDC will not recommend N-95 or surgical masks because the first responders and healthcare people need them more, and they are in short supply and expensive, thanks to most of them not being produced in this country (guess where they are produced???).
Medpage Today, September 8, 2021
3- Federal COVID Recommendations and following medical science?
The COVID-19 vaccine is the greatest scientific advance in medicine. The spread of the pandemic without an effective vaccine would have been catastrophic.
2 FDA officials have resigned (retired) and leave in October from the Office of Vaccines and Research because of undo pressure from the White House to pressure them in their analysis of issues relating to the current vaccines. (Dr. Marion Gruber lead this office while Dr. Philip Krause is a member and had decades of experience in vaccines. ) This is the office that provides the major input to the FDA on vaccines. Medicinenet.com
The politicians just won’t let medicine stay impartial and non-political. They must be independent organizations free of administrative powers. As we go forward many questions continue to go unanswered. There are groups who will not even accept good solid science and have been declared Antivaxxers if they don’t reach the right conclusions.
When we were early in the pandemic, both political sides insisted on following the science, since the virus was so new and we had little information. Things have certainly changed.
We had experience with previous epidemics, SARS, MERS, and severe Flu epidemics (1918, 2003,etc.). We did not learn much of a lesson, because the federal government had no significant plans for the next one, which had been predicted.
No PPEs(personal protective equipment) made in this country, inadequate ventilators, and no backup plans when hospitals were overwhelmed by COVID patients, while other sick individuals could not receive adequate care. Preventive care and elective surgeries were greatly postponed.
Still, when an entire hospital was built for NYC, they didn’t use it, and the Navy hospital ship specifically designed for COVID patients, while sick nursing home patients were sent back to their senior centers causing 15,000 deaths.
We need an independent task force created to deal with our inadequate preparation for national crises.
Even if this pandemic came from a bat, we should have been better prepared for a crisis of the magnitude of this pandemic.
Most honest experts now feel the liklihood of this novel coronavirus came from the Wuhan Chinese Communist Party labs is much more likely (because of the manipulation of that virus to make it more deadly and highly transmissible—“gain of function” research, which was different from the sequencing of the original virus). The latest information divulged by the press is that this modified coronavirus was actually put in Chinese bat caves to see how they would handle the more aggressive virus. Where is that data? What happened?? China must be called out and disciplined by the rest of the world. But with U.S. fingerprints all over the “gain of function” research in our country and China, you will hear nothing….crickets!!
The Chinese people are not at fault and should not be bullied, thought badly of, and treated with respect as we should all people. Radical rights and lefts are so injurious to the health and welfare of our blessed country.
Spreading fear backed up by politically motivated public health experts (some of these are political advisors more than trusted medical experts) were more interested in counting cases rather than doing more research to provide the public with better diagnostic tests, antibody tests to prove immunity, and better treatments. Thank God, the “warp speed program” got things going much faster than the typical bureaucratic snail pace that would have been so bogged down in paper work, that it would have cost millions more lives.
Many of the early treatments were modeled after a severe respiratory disease called ARDS (acute respiratory distress syndrome), which for many was dead wrong, causing the death of hundreds if not thousands of patients with too high pressure from ventilators, wrong treatments, etc. Clinical doctors actually taking care of these patients figured it out, not the academicians, and turned the ICU and death rate around.
The booster research has yet to prove a third dose is safe or necessary except for those who did not respond well to the first round of vaccines.
Because of emergency authorization use to get the vaccines produced and distributed at a rapid pace thankfully, many of us took it mostly on faith that we be vaccinated, however, about 30% questioned the research including the safety. Just in the last month the FDA finally fully approved Pfizer vaccine (with tremendous federal pressure), which was the main reason for the resignation of those FDA experts. They and many experts want solid answers before recommending next steps. We still have 25% unvaccinated.
For trust in the government (12%) to improve, there must be honest, open, transparent, and understandable messages that don’t change by the month. I am thankful, we have had as many Americans get the vaccine, but we can forget those who have refused vaccines all their lives.
Space between doses of vaccine questioned
Space between the first and second dose of a 2 dose vaccine is being questioned. Dr. Marty Makary*, a trusted expert, feels 3 months between the first and second dose would have been much better than 3-4 weeks.
He and others also continue to question why the administration (CDC too) do not acknowledge the immune response from those infected with COVID-19. And now the need for a booster and its timing is also in question, especially for healthy individuals, that children need to be vaccinated by mandate, that federal employees are singled out as being mandated to receive the vaccine, that masks are necessary outside in certain circumstances, that most masks prevent spread, that lockdowns work (and don’t), and that keeping people unemployed with federal stimulus checks will bring us out of this economic crisis, etc.
*Dr. Marty Makary. M.D., MPH is in the Department of Public Health at Johns Hopkins Medical Center, one of the top center for public health monitoring and research and chief editor of the internet journal Medpage.
Previously infected individuals have good immune repsonses
The latest information coming from Israel, which has been the leading country with the most reliable research, found that infected people are 27X more likely to have adequate immunity against COVID-19 than those unvaccinated. Of course, their levels will wane just as those vaccinated, but the timing is still in question. The consensus is 8-12 months.
Will the administration use this science to finally admit that previously infected people may not need vaccination or at most one dose? When further mandates are dictated, these people will be considered in violation, and fined or fired, or require weekly testing. Will they be allowed on public transportation, go to restaurants, and be included in those who just refuse vaccination?
Now companies with 100 or more employees must get vaccinated or be tested weekly affecting 100 million workers. How many will quit their job and live off the government?
When abortion is brought up, it is all about “my body, my choice”, but when it comes to mandates for vaccines, it doesn’t apply. The public just isn’t that stupid. We can’t have it both ways!
Of course, lawsuits will be forthcoming. The states, not the federal government have to power to compel residents to be vaccinated.
Experts feel based on the pace of the delta variant in other countries that the U.S. is about to peak and we will experience less infections within the next month. We will see!! Other variants are being watched to see if there is a chance of more resistant strains coming our way (Mu and R-1).
References mdlinx, Sept. 14, 2021; White House Briefing found on Medicine.net
President Biden is also lifting restrictions in November on fully vaccinated foreign travelers to travel to the U.S., just when we are desperately trying to control this virus. This includes China and Iran. Requirements include proof of vaccination (forgery easy to come by) with a negative test within 3 days of travel. What about the southern border crisis and refugees from Afghanistan???......crickets!
4- Vaccine side effects and long term COVID infection syndrome-update
Vaccine safety is on the minds of all of us. Fortunately, the risk of serious side effects are only known for the first year, since the vaccines have not been around much longer than that. The usual side effects of almost all vaccine can cause fever, muscle ache, headache, and fatigue. Of course there are other constitutional symptoms that occur rarely.
However, studies have concluded that myocarditis in young males, rarely Gullain-Barre’ syndrome, a paralyzing illness that usually resolves. The COVID infection can cause these more serious illnesses too, but it has been declared that the two above illnesses are increased in COVID vaccines, and most of the studies centered on Moderna. These black box warnings on the label are required.
The second dose carries a higher risk, and has inititiated many studies to determine the necessity for a second dose, even though the immunological response is higher with the second dose, but that is the reason the side effects are higher too.
There is a small percentage of COVID patients that continue to have symptoms after they recover from active infection and are test negative. It is call the Long term COVID syndrome. Headache, fatigue, muscle and joint pain are the most common symptoms reported. Of course, these symptoms are highly subjective, but a recent study found that chronic fatigue continues to be a prominent symptom. In a support group of long termers (239), 87% continued to experience chronic fatigue 11 weeks after symptoms onset, reported in the Netherlands, presented at a European Respiratory Society meeting. At week 24, 79% still reported fatigue. The concern with these patients is winding up with classic chronic fatigue syndrome, now in a group of symptoms termed Central Sensitivity Syndrome. I have discussed this syndrome in a previous report which can be found in my subject index on the homepage of the website.
This syndrome is a real diagnosis, but too soon to assume these patients will continue to have a permanent syndrome. This study came out of a support group of long COVID termers, so we will see how this progresses.
If people continue to have long term symptoms, it is imperative they seek evaluation from their physicians, as there could be other diagnoses hiding in this situation.
Medpage Today, September 7, 2021
5- Effectiveness of the vaccine against the Delta Variant; what about those previously infected and have immunity?
The Delta variant is more contagious but less virulent! (more cases but not a high death rate compared to other outbreaks)
COVID vaccination percentage-- Fully vaccinated--64% of adults, and 80% over 65. 65% of Floridians and 57% of Georgians. Some Southern states are still 47%
The Pfizer and Moderna vaccines (and probably the J&J) have all shown over 90% effectiveness against the original viral mutant (alpha variant), but how do they stack up against the delta variant? The CDC study states that the Pfizer vaccine is 66% effective against the delta variant, still very good protection, while Moderna remains at 80+%, and J&J holds at 66%. These are all still good effectiveness.
The data shows similar rates against the alpha variant, but Moderna and Johnson and Johnson vaccines still do not have full FDA approval, although studies actually show Moderna vaccines create even higher immunity than Pfizer (still don’t know what that actually means, since both are over 90% effective initially, but against the delta variant is.
This effectiveness for all vaccines was for symptomatic and asymptomatic infection. The delta variant is twice as contagious as the alpha variant causing twice the number of hospitalizations according to MedPage Today. Most of this study found almost ¾ were unvaccinated. Medpage Today, August 27, 2021 it should be noted that people can still be quite sick and stay at home, usually requiring 1-2 weeks to get over the symptoms.
Pfizer is still the only vaccination FDA fully approved, while Moderna and J&J has emergency use authorization only. The English study showed about a fourth of cases were delta variant, but the U.S. is seeing greater numbers of delta.
This delta variant is twice as contagious (transmissible) but may be slightly more virulent (deadly) than previous variants. It is reported the unvaccinated that have these more serious infections, not the vaccinated. The delta variant is the predominant strain now in the U.S. and is the reason we are seeing more cases and hospitalizations in the invaccinated. It has been detected in 150 countries. Children are more susceptible to the delta variant but still much less likely to have a symptomatic infection.
Most of the credible research does not address “memory immunity”, and until we find out more about that, we will not have a full picture of effectiveness. It turns out, the body’s memory T-cells become effective about the 8th month after infection or vaccination. This plays a role in the question of need and timing of a booster.
The CDC performed a study on healthcare professionals and is published on the CDC website under the Morbidity and Mortality Weekly Report, August 27, 2021. The lead author was Dr. Ashley Fowlkes, Department of Virology, CDC, my daughter! Nice to see her name in lights.
89% of the infections were symptomatic, and the effectiveness was 66% in the delta variant compared to the alpha variant at 90%. One study stated that the J&J vaccine was 77%.
Those unvaccinated outside this study still are getting infected 5X more likely over the fully vaccinated, 30X more likely to be hospitalized. This underscores the need for vaccination, according to the CDC.
Many hospitals quote 95% of COVID infections are unvaccinated. What does that tell anyone??? Get vaccinated!!
Breakthrough infections in fully vaccinated
It is also known now that even though there are breakthrough infections in those fully vaccinated, they can transmit the virus but not for as long. The rate is 0.2% chance, so the vaccination have an amazing protective rate.
This means the body is fighting the virus in the nose and nasopharynx and quickly can drop the viral load making them less infectious. Breakthrough infections are much less likely to be hospitalized and routinely have only mild symptoms (unknown how many may be asymptomatic). Use common sense and realize you could infect a vulnerable person who could have severe disease and die including those unable to be vaccinated.
Johnson and Johnson Vaccine
For the 14 million Americans who received the J&J vaccine, the latest study from South Africa is that it is 71% (66% in another study) effective against the delta variant for hospitalization and 95% against the risk of death.
American Association of Medical Colleges, August 31, 2021
Moderna vaccine more effective than Pfizer….a little
There are studies proving the Moderna vaccine causes a higher immune response than Pfizer for the delta variant (93% against hospitalizations compared to Pfizer at 88% and 71% for J&J). These are all extremely high percentages, and rarely seen in vaccines for other diseases. We still need to know the antibody levels and what they actually mean regarding preventing disease and hospitalizations.
Moderna reported more cases of myocarditis (and pericarditis) in young males (average age of 33 in a Canadian study) and caused a pause in production earlier this year, but was cleared with the warning that there is small but significant risk in all vaccines. These pauses are not uncommon when a drug or vaccine is in clinical trials. 10 cases per 10,000 doses for both vaccines. The question is what % effectiveness could be attained and not cause any of these serious side effects. There is always a tradeoff for more highly effective vaccine.
Most of these myocarditis cases did not progress to severe cardiac complications and even though there were significant symptoms of chest pain, shortness of the breath, and fatigue occurring within 2-3 weeks after vaccination, most had complete recovery, but may take weeks.. MedRxiv, September 16, 2021
For more information on myocarditis log on to my last report under the subject cardiomyopathy: www.themedicalnewsreport.com #115
Nasal spray vaccine research in animal laboratories are being performed in a few centers, however, it is amazing to me that such a simple way to introduce a vaccine into the very area of infection beginning is not being aggressively undertaken. Flumist is a FDA approved nasal spray that uses attenuated live virus. Why don’t we have a nasal spray vaccine to combat this virus right now?? So simple….. It is clear that intramuscular vaccines are far from perfect. Medpage Today, September 5, 2021
Combination vaccines are being tested and can add the flu vaccine to the COVID vaccine in one shot. Novavax and Moderna are leading the way. Hopefully it will be approved. Medpage, September 18, 2021
This is nothing new as childhood shots are combined (DPT and MMR)* for example.
*Diphtheria, Pertussis, tetanus, and measles, mumps and Rubella
Pfizer states vaccine is safe and effective for children 5-11
There were few side effects and no cases of myocarditis. Pfizer will apply for FDA approval in near future. News Release, September 20, 2021
Kids being hospitalized usually have obesity, diabetes, or brain disorders followed by asthmatics. Most are older than 12, so the vaccines should be protective, since as in adults, most are not vaccinated. They present with pneumonia, vomiting or diarrhea. Fortunately, few children die. Medicine.net, Sept. 22, 2021
The strength of the dose for younger children will definitely be reduced if approved, but that may be different for different vaccines.
Previously infected individuals have better immunity
Medpage Today, August 28, 2021 cited a Israeli study that those who got vaccinated with the Pfizer vaccine had a 13-fold increase in contracting a breakthrough infection than someone who was actually infected previously with the virus and then got re-infected. However those previously infected who got one dose of Pfizer conferred even greater protection against re-infection And none of these groups studied no deaths.
So I ask you, why isn’t this information common knowledge?……we know!
Side effects of vaccines are often used as an excuse when the latest scientific proof has announce these vaccines are some of the safest vaccines ever produced. Only 1 in 6800 develop myocarditis in young males primarily, while headache, fever, myalgia, and fatigue are the usual side effects of most vaccines.
Guillain Barre’ Syndrome, a neurological paralysis, which can happen in many vaccines has been found to occur in the J&J vaccination in 0.0008% of the 12 million doses administered. Pfizer and Moderna does not have a statistically significant number.
GB syndrome can occur following certain other viral infections as well. Most fully recover regardless of the cause. Lower extremity weakness usually is the first symptom with progression upward, and is a very scary paralysis until it starts to resolve, still requiring a lot of rehabilitation.
6- FDA limits approval for the Pfizer booster, but then the White House steps in!
The FDA only approved the Pfizer vaccine for those immunocompromised initially, and then included those 65 and over (that excludes Moderna and J&J recipients).
Later they infection also included those at higher risk to contract severe infection, which is synonymous with those with underlying illnesses. However, in his news conference, Biden stated groups like teachers are eligible as are healthcare workers, who may or may not be at risk based on their pre-existing conditions. That is not what the FDA said.
I am tired of non-medical people twisting the recommendations of medical institutions. Basically all federal employees have already been mandated to get the vaccine, and I would assume the booster will follow.
As usual, there is political interference with an agency (FDA) that should be independent of the executive branch, but just like the CDC, they are all federal employees, under control of the federal government. That is the problem!
If a person is immunocompromised and under 65, they would be eligible, but should consult with their doctor, as many of that group may have had a good immune response from vaccination, while certain conditions and medication may have lowered the immunological response in others.
The delta virus was the main stimulus to go forward with boosters from data in Israel. From June to August, their cases went from 20 per day to 10,000. They stated that 2 factors caused this issue—waning immunity and resistance to the delta variant. Those who did not receive the booster were 11X more likely to get infected than those with the booster. The booster also reduced more severe infection in that group vs the non-booster group. Israel is the only other country authorizing a booster besides the U.S. in the world. However, untilall countries gets the virus under control, transmission from one country to another will continue.
Most third world countries have barely vaccinated their citizens, and of course the WHO and other countries are complaining that our countries are getting a third shot while many countries haven’t even received enough vaccine to make a dent in their population.
NEJM, September 15, 2021
The vaccine companies can’t even decide what is the right actual dose for a booster. Pfizer states the full dose is necessary. Moderna says a half a dose is plenty effective. Obviously the smaller the dose, the fewer the side effects.
It was reported in this Medpage Today communication that Moderna has known since early this year that a half dose of their vaccine is as effective as the whole dose, and even a quarter dose may enough. This is the first time I have seen this information and is not common knowledge.
Booster doses for vaccines are often lower doses, because it is meant to remind the body’s immune system to be at full strength to fight any exposure to the virus. Examples stated are tuberculosis, meningitis, and yellow fever.
Pfizer and Moderna have lower dose research going on currently, obviously to reduce side effects.
Lower doses could reduce complications from the vaccine. Fewer cases of myocarditis in younger individuals receiving the COVID-19 vaccine would be welcome. However, for now, no one is eligible for the booster under 65 except for the immunocompromised or at high risk for a severe infection, which should mean the same thing. The FDA actually required Pfizer to look at their dose strength as a condition for fully approving the two shot series.
Side effects and safety are the main reason for vaccine hesitancy plus distrust in government, but with emergency use authorization, the FDA was able to approve the vaccine in a matter of months rather than years thanks to the Trump Administration. Otherwise we would still be waiting for a vaccine.
Crises require fast action even when it their actions may be more risky, and in this case prevented millions of cases and deaths. Thankfully, studies on side effects continue to show very small numbers of serious side effects.
There is no doubt that the immune system may begin to slow after 8 months to 1 year, and the feds feel that is enough reason to recommend the booster with an interval of 6 months since the last dose of vaccine. But solid science is lacking.
Interval between first and second dose now questioned
There is still debate and some science to prove that getting the second dose of the COVID-19 vaccine was too soon (3-4 weeks), and Dr. Marty Makary of Johns Hopkins not only stated that in Medpage (also Editor of Medpage, the internet journal), stated that the interval between doses should have been 3 months instead of 3-4 weeks, which would have given the body more time to mount a solid lasting immune response. His contention is that getting the second dose so soon as we did may be the reason the immune levels started to wane after 8-10 months and now requires a booster. Pfizer only made $89 billion dollars this year.
There is plenty of data to prove that there is good immunity even at a year in most healthy people, but those who may have not had a good immune response with the first 2 doses (immunosuppressed), getting a booster at 6-8 months may make sense.
Double blind peer reviewed studies are the only way to make a science based decision, and that has not been completed on boosters.
We have no scientific evidence that a third dose will give better protection against the virus and its variants. There is a some early evidence from Israel that boosters diminish the risk of getting infected and having severe disease in people over 60 as stated earlier, but only suggestion in their data, and we need to see the data, not yet published.
Pfizer hasn’t provided the public with data regarding side effects from a third dose either.
As always, discuss this issue with your doctor before getting a booster.
Medpage Today, August 24, 2021, Vinay Prasad, MD, MPH
If the FDA approved the Pfizer vaccine for only immunocompromised individuals, under the PREP ACT, the vaccine companies are protected from liability and according to the CDC, and that is only the immunocompromised.
Biden has confused doctors and the public alike that these boosters are available September 20, but I am aware of many individuals who have had their booster long before September 20. The pharmacist is being responsible for deciding who gets the booster. ??
As always, check with your doctor before receiving the booster! And know your rights! CDC website, Medpage Today, August 30, 2021
7- Monoclonal antibody centers open throughout Florida in over 20 sites for prevention (if exposed) and early treatment; now being rationed do to overuse
Monoclonal antibodies (Regeneron) given in an IV infusion or as a subcutaneous injection treatment that will keep 70% of newly infected individuals out of the hospitals and reduce the chance of death by 70% as well, according to infectious disease experts Dr. Shifki and Dr. Battacharyan interviewed on a One America News television special. I am sure this effort will be duplicated in other states, especially those with higher rates. It is available in even smaller towns such as Clayton, Georgia (North Georgia) in medical facilities. But there is now a shortage of these shots.
This is free from the federal government. It hits the delta variant just as well as the other variants. The brand name is Regeneron and should be given to anyone who has recently been infected…the sooner the better. Most people will note considerable symptomatic improvement with 24-48 hours.
It can be given as a preventative if you are exposed to an obviously infected individual. It will prevent infection in 82% of patients. Nursing homes, spouses, etc. should take advantage of this treatment.
Allergic reactions are very rare, but can be handled in emergency facilities (rash, swelling, shortness of breath).
Why has the federal government and media not been promoting it. They are limiting distribution in Florida for political reasons, some say.
Once again, the private physician has been left out of the equation, and even some of them are not familiar with the value of the treatment.
This treatment or preventative can be used in anyone including those vaccinated or not. This should not prevent someone from proceeding with vaccination, but I suspect the feds didn’t promote it because of that very fear that some would not get vaccinated.
Once again, the truth about all aspects of diagnosis, prevention, and treatment have been politicized, and there is no place for this in healthcare.
8- Mu Variant
Most of you have heard about the Mu variant (the next after Llamba in the Greek letters), and it is too soon to know much about it, but after it appeared in Colombia, South America, it has not come to the U.S. in any major numbers, according to experts from the University of Washington and Baylor Medical Center. The Mu mutation is considered a variant of interest by researchers. I doubt it can compete with the delta variant. Now in Japan, the R-1 variant has been discovered. Too soon to know if it will be of interest in the U.S.
Regardless of the variant, it is predicted to be well covered by current vaccines especially against hospitalized cases. The fewer people unvaccinated, the lower the chance for predominance of any future variant.
Medscape, September 9, 2021
9- Cases rising in children; vaccines for 5-12 year olds being studied
As school has begun, there has been a rise in the number of cases in children, in contrast to earlier in the pandemic. Since the beginning of this viral challenge they have represented 14.8% of the cases, but in this August, their rate rose to 22.4% of the total cases, according to the American Academy of Pediatrics. Most of these kids are not yet eligible for vaccination. However, it is very clear that severe illness is quite low unless they have underlying medical conditions similar to adults.
Universal masks by the CDC for all indoor school activities is recommended, although there are states still not making it mandatory. After all, it is a recommendation not a law. States still have the authority to decide such an issue. While most children’s cases are very mild, the states not complying do have higher rates.
Certain cities are mandating vaccines for all school staff (New York City, Chicago, and all of California). While certain experts insist there is scientific proof that masks work, I have addressed that fallacy many times, and only surgical masks and N-95 masks help some, while cloth and other porous fabrics, and paper masks provide no protection unless 3 ply.
And at the same time, boosters are being recommended for all 12 and above, many pediatricians stated that the immune system of younger people are adequately protected with the standard doses and don’t necessarily need a booster.
10. Who has not vaccinated?
1. 12 million children under 12 not eligible.
2. 29% of those unvaccinated are between 12-24.
3. Texas has the highest number of unvaccinated counting thousands of illegals. (9% of the U>S. population and 10% of cases).
4. There are twice as many uninsured people who refuse the vaccine, when the vaccine is free (22% of uninsured while 13% are insured in a study by the CDC).
USA Facts website
Stroke is the fifth leading cause of death in the U.S. with annual costs of $70 billion+. Nearly 800,000 experience stroke per year. If not treated in the first few hours with anti-blood clot therapy (anticoagulants) or removal of certain selected clots, strokes may be permanent.
TIA—transient ischemic attack
Stroke symptoms may occur for a few hours and then totally dissipate, which is a warning sign that certain parts of the brain are not receiving adequate blood flow perhaps temporarily and are usually of the ischemic type. This is caused by a blood clot or narrowing of a vessel followed by clotting. 240,000 Americans experience a TIA every year.
7.5% to 17.4% of patients with transient ischemic attack (TIA) experience a stroke within 3 months with half the risk occurring within 48 hours of experiencing a TIA.
1 in 3 TIAs will eventually have a stroke. It is imperative these transitory symptoms are not ignored. If a person experiences any neurological symptoms, they should consider seeking assistance immediately.
The classic symptoms of a stroke or TIA include weakness of one side of the body, slurred speech, vision difficulty including temporary blindness or double vision. Vertigo or imbalance can also occur.
This reminder will help patients and families be on the alert for an impending stroke.
700,000 out of the 800,000 strokes annually are ischemic (lack of blood flow) in nature (the other is hemorrhagic type—bleeding in the brain).
A TIA has specific symptoms that occur and usually fade over hours with no evidence of CT scan ischemia or infarction.
Cause of TIAs
The most common causes of TIAs and strokes is vasoconstriction, atherosclerotic disease of the vessels, emboli, hypercoagulability (thick blood), low blood pressure or reduced flow to a specific part of the brain (microvascular blockage). Other causes include vasculitis (type of inflammation of blood vessels usually autoimmune).
During a TIA, arterial flow to brain tissue is temporarily disrupted causing, for example, localized (focal) signs including hemiparesis (weakness of a limb), however, with spontaneous flow restoration, the result reverses the signs and symptoms without permanent tissue injury or evidence of any sign of the symptoms. Otherwise, a stroke will occur with progression of ischemia (loss of blood flow) and infarction (death of tissue).
Brain imaging (MRI or CT with contrast) should not show evidence of damage if only a TIA, otherwise, it would be defined as a stroke, ischemic type. If symptoms last longer than 24 hours, there will likely be a stroke.
Hypoglycemia (low blood sugar), stroke (hemorrhagic type), and a seizure must be ruled out.
MRI should be performed immediately and certainly within the first 24 hours. A non-contrast CT scan is second best, but much less expensive and more readily available. If a TIA is suspected, a CT scan may be performed first. As many as 25% of areas of ischemia or evidence of hemorrhage can be seen with CT. These tests must be performed as soon as a patient is seen, so that anticoagulant therapy can be started or should not. If a stroke from bleeding in the brain (hemorrhagic) is seen, anticoagulants would not be used, as it would further the bleeding.
A blood count, including blood clotting studies, and electrolytes must be ordered. An EKG to rule out heart attack, arrhythmia especially atrial fibrillation is routine. An EEG might be recommended if a seizure is suspected.
Those with known cardiovascular disease including hypertension, metabolic diseases such as diabetes, age over 60 all increase the liklihood of a cerebrovacular accident (CVA)-stroke.
Hospitalization is usually recommended to accelerate the workup and treatments depending on the cause. Treatment must be started in the first 4-6 hours for best results, if an ischemic stroke is diagnosed.
Intravenous blood thinners
Patients frequently have atrial fibrillation and or carotid stenosis, however, if not present, patients need dual anticoagulant therapy (aspirin and clopidigrel-Plavix) for 3 weeks. Heparin short term or Dipyridamole (Persantine) are also options in selected cases.
Atrial fibrillation must be addressed in a timely manner to prevent blood clots forming in the heart and creating emboli to either the lungs or the brain.
The atria of the heart quiver instead of contracting regularly because of an electrical disturbance in the heart wall. This causes the blood to swirl in the atrium and tiny clots are prone to occur. Single therapy anticoagulants must be started immediately as the arrhythmia treatment is decided.
If the patient has symptomatic carotid stenosis, carotid revascularization (endarterectomy) should be performed, and both atrial fibrillation and carotid stenosis patients anticoagulants should be started on single therapy anticoagulant until surgery can be performed.
For non-embolic TIAs, aspirin (50-325mg), dipyridamole, clopidogrel (Plavix) are first options.
For patients with a clinical stroke and severe disability, they should be started on intravenous alteplase, which can improve the disabilities in 39% of the cases or tissue plasminogen activator (tPA) which increased recovery by 26% when administered within 3-4.5 hours of the stroke.
Mechanical removal of blood clot (thrombectomy)
When a clot is found in one of the larger cerebrovascular vessels, mechanical thrombectomy within 6 hours in comparison to medical therapy or when treated within 6-24 hours, results are superior.
Intravenous blood thinners only in patients with carotid artery or middle meningeal artery blood clot will reverse a stroke in 10-15% and 25-50% respectively.
There are two techniques to remove a clot:
a) a stent retriever (2 images) is run up from the groin in the femaoral artery right up in the brain blood vessels and the basket like apparatus grabs the clot and it is removed.
b) aspiration catheter—if the clot can be aspirated, it can removed, or a laser may be able to drill a hole in the clot allowing blood flow to be restored.
These devices are threaded from the femoral artery (groin) or the radial artery (wrist). These techniques performed in the first 6 hours give almost twice the relief of stroke, although both mechanical and medical treatment still fails in almost 50% of the cases.
There is a lot of decision making in a very short time, so patients and family’s must decide with the treating doctors what route to take.
JAMA, March 16, 2021
Careful management of blood pressure elevation, EKG monitoring, monitoring of symptoms, and treatment modalities with follow up blood studies are indicated.
Long term management
Management of weight, underlying diseases, blood pressure, lipid reduction, glucose control, smoking cessation, alcohol control, and exercise programs are necessary to reduce the chances of another TIA or sroke.
A new report from the United Nations estimates 29 million women and children are living in slavery of some type including a massive issue as thousands per month are passing into our country through the porous southern border. A spokesman for Walk Free antislavery organization, a UN organization, says this means 1 in every 130 women are affected globally, more than any time in recorded history.
They define slavery as a person who is removed from freedom and exploited for money or personal gain.
Women account for 99% of victims of forced sexual exploitation, 84% of forced marriages often as a child, and 58% of forced labor.
They state that the face of slavery has radically changed. COVID-19 has accelerated this problem and become a “normalized exploitation in our economy. The sex trade has exploded across borders with a transnational supply chain and migration pathways for the modern slave trade.
These numbers are very conservative according to these spokesmen. Forced and child marriages have skyrocketed since the pandemic.
The Walk Free organization and the UN are launching an international campaign to eliminate modern slavery.
136 countries still do not criminalize forced and child marriages.
The campaign wants to eliminate a legalized system called keyfala, for which legally binds a migrant worker’s immigration status to an employer or sponsor for the contract period. They also are calling for transparency between countries and accountability for multinationals.
This occurs in “sweat shops” around the world making clothing, coffee, and technology.
Will our country join this campaign, since slavery issues is an ever-present concern in our country especially as the current administration turns their back on border control.
Human Trafficking Hotline 1-888-373-7888.
The Trafficking Victims Protection Act of 2000. With bipartisan support, the Congress appropriated $250 million toward these efforts in 2019 with a 3 pronged effort toward sex trafficking, labor trafficking, prevention, prosecution, and protection. Through the Department of Health and Human Resources, they are providing direct services to children including children used in child pornography.
It also includes school education about these issues. It has been mandated that any information toward these issues be reported to the U.S. Embassies. It supports the national hotline, informing law enforcement, requirements for victim screening. This immigration issue has skyrocketed across our borders and deserves more attention regarding rampant trafficking.
An extensive report is available at: www.polarisproject.org
34 million Americans have type 2 diabetes and 1 in 5 don’t know it. 88 million have prediabetes and 84% of them don’t know it, according to the CDC. The rate of diabetes has more than doubled over the past 20 years because of aging of our population and obesity. Type 1 diabetes is increasing as well.
There are many advances in the diagnosis and treatment. Here are some of the highlights.
A) Diabetic drug effective for weight loss in non-diabetics
B) Other diabetic drugs reduce heart failure and kidney disease
C) USPSTF lowers age for diabetic screening as diabetes increases in children and adults
D) The natural course of prediabetes
A) Diabetic drug effective for weight loss
It has been reported that the FDA approved injectible drug, semiglutide 2.5 mg (Ozempic), given weekly, does create significant weight loss when type 2 diabetics limit calories, are on an exercise program along with the medication. The average weight has been 35-40lbs.
Now a double blind clinical trial (2000 participants in 129 centers) tested the effects on non-diabetic overweight participants and found essentially the same. The weekly injection was performed for 68 weeks. NEJM, Feb. 10,2021
Hypoglycemia was no more common in the medication group than those receiving the placebo (but still were on the same diet and exercise program). However, gastrointestinal symptoms and even pancreatitis can occur.
The goal for most diabetics is to lose 5% of body weight to assist the control of their diabetes.
This regimen is showing loss of 15-20% of body weight. However, it appears that those overweight can benefit from this diabetic drug without dropping their blood sugar to low levels. This provides new hope for overweight people to possibly prevent cardiovascular disease and prevent type 2 diabetes. No oral weight loss pill can achieve these results (phentermine-7.5%). Only bariatric surgery, a very invasive procedure, can achieve similar or even better results.
It has to be kept in mind that the medication must be used in association with proper dietary and exercise behavior. But it is well known that diet and exercise alone are not enough to lose significant amounts of weight and maintain it.
The cost is an issue-- $1000 a month. Insurance usually covers it for diabetics, but others would be out the money, but it should be covered for all considering the enormous cost of diabetic complications, cardiovascular disease, and other obesity related complications.
This study will give renewed hope in losing weight for those who are significantly over weight regardless of being diabetic or not. It is not FDA approved for non-diabetics.
I recently discussed all the diabetic medications at length, and if interested, click on Medical Report 106
B) Other Anti-diabetic meds have major value too
Canagliflozin (Invokana, Farxiga, Jardiance), a sodium glucose cotransporter 2(SGLt-2), is another subgroup of medications used to treat type 2 diabetes that have been found to have far reaching value in type 2 diabetics.
This medication has been discovered not only to manage diabetes, but reduce the heart failure, hospitalizations, and slow the progression of kidney disease. It also helps reduce weight in diabetics.
It is now being used off label for non-diabetics with cardiovascular and kidney disease.
C) USPSTF lowers age for diabetic screening in overweight and obese individuals
The rate of diabetes is rising the fastest in those 20 and younger as the rate of obesity is rapidly rising in children and adults. There are 120 million diabetics and 88 million prediabetics.
The U.S. Preventative Services Task Force has lowered the age to 35 (to 70) for overweight or obese individuals (was 40-70) to be screened for prediabetes and type 2 diabetes every 3 years.
Especially prone to developing diabetes are blacks, Native Americans and native Alaskans, Native Hawaiians, Pacific Islanders, Latino, and Asians. These groups might benefit screening for diabetes even before age 35, according to the federal agency.
Metformin is recommended if the blood sugar is at a prediabetic level or greater (100mg/dl or greater), and counseling should be offered including diet and exercise.
It was pointed out that starting Metformin may prevent the development of diabetes but is not FDA approved for that use.
Being overweight or obese has become epidemic in the U.S. and has necessitated screening for such weight related diseases at earlier and earlier ages.
In the U.S.,18.5% of children and adolescents (2-19) are obese (22% in blacks and 25% in Latinos), according to the CDC.
D) The natural course of prediabetes and how to change it
Diabetes is a neurovascular disease and is associated with an elevated incidence of heart attacks, strokes, kidney disease, and other microvascular events. The key is to diagnose this disease at the prediabetes level.
About one half of older Americans are prediabetic. This
was defined as a HbA-1c (hemoglobin A-1c) of 5.7-6.4% and a glucose level of 100-125mg/dl
On average between 9-13% progessed to a diagnosis of type 2 diabetes over a 6.5 year follow up.
This is an excellent reason to have annual exam and testing of the blood glucose. It is in the prediabetes range, now is the time to manage this issue with lifestyle modifications, diet, weight loss, exercise, and better nutrition.
It is well known as the average weight of U.S. individuals continue to rise, diabetes will become epidemic without major behavior modification in our country. The current pandemic has packed on between 10-15 pounds average on average, another risk factor for increasing diabetes.
We have so many crisis we are dealing with, but keep in mind diabetes is one of the most potent underlying diseases that increase the risk of heart disease, kidney failure, and worsening of COVID-19.
Prediabetes is usually symptom-free, while early symptoms as they appear can range from abnormal thirst and hunger with increased urination, vision change, numbness and tingling in the feet, slower healing of skin wounds, and leg ulcers and phlebitis leading to amputation.
There are certain factors that influence the progression of pre-diabetes to type-2 diabetes.
1- The level of fasting blood sugar (>100-125mg/dl for prediabetes). Persistent elevated blood sugar will progress to diabetes and the complications of the disease.
2- High BMI (waist size)
3- Weight gain
4- Younger age
5- High plasma insulin
6- Insulin resistance (poor response of insulin on blood sugar)
7- High blood fats (cholesterol and triglycerides)
9- Poor function of the pancreatic islet cells that make insulin, caused by persistent elevations of blood glucose and lipids, inflammation in the body, amyloid, and oxidative metabolic stress.
10- Choice of treatment
With 11% of Americans diagnosed with diabetes and 27% over 65, this is an epidemic. 79 million Americans have prediabetes and 7 million with type-2 diabetes. Once oral therapy is initiated, it is estimated that progression requiring more intensive therapy takes an average of 7 years with complications showing up in 7-10 years.
But prediabetes can be treated and reverse the inevitable progression to clinical diabetes. There is a movement to treat prediabetes earlier than before, since metformin (sulfonyureas) and other drugs can lower the blood sugar with diet, weight loss, and exercise, and many cases prevent progression.
Early diabetes treated with insulin can potentially reverse the trend within a year according to studies discussed in a great article by the ADA*. In fact, studies note that insulin therapy outpaces the benefits of sulfonyureas in keeping the blood sugar near 95mg/dl. It is therefore critical to diagnose this disease as early as possible. Early diagnosis and early intervention with a treatment regimen is making a difference in reversing the progression of pre-diabetes to type-2 diabetes.
Treatment must include management of the above 10 factors to realize prevention of progession and complications of diabetes. A-1c (keeping it less than 5.7%) is a good indication of whether there is maximum benefits to prevent microvascular deterioration, but not to be used as indication of daily treatment.
Also it is critical to not only maintain fasting blood sugars at 95mg/dl but also keeping the post-meal blood sugar from spiking. If this can be accomplished, there is evidence that pancreatic beta (islet cell) cells can regenerate allowing better function of insulin production and less resistance.
As always, the program by the treating physician is critical to match these protocols with specific types of patients willing to follow the program, monitor blood sugars regularly and compulsively manage blood sugars. Without a very motivated patient and treating physician, there is little liklihood of accomplishing these goals.
*ADA=American Diabetes Association
JAMA-Internal Medicine, Feb 6, 2021
Everyone is familiar with our sleep wake cycle, but there are many mechanisms going on in our body that occur of medical importance. Besides the ones well known, intrinsic clocks determine most all circadian cycles in physiology including daily variation in blood pressure, heart rate, hormone levels, respiratory and exercise capacity, and even blood clotting.
It is now known that during the day certain pathologic events occur at specific times of the day indicating it contributes to disease processes. The central function of the clock system is to drive periods of energy acquisition and use in anticipation of the day/night cycle. Understanding these mechanisms give medicine a chance to prevent and perhaps treat disease.
Light drives the 24 hour hour cycle that coincides with the daily rotation of the earth.
The word circadian is derived from Latin meaning “about a day”-circa diem. Diurnal means active during the day and nocturnal means active at night.
This complicated drawing shows how all of these organs are governed by internal clocks which come from the brain (hypothalamus), which are connected to internal clocks in all the major organs. Think of this internal system as a pacemaker with neural connections to all these sites. Metabolic signals control these clocks on the cellular level.
All this starts with light stimulating certain eye retinal cells (rods and cones photoreceptors). This stimulates those brain receptors that set off a cascade of coordinated moves through the pituitary for endocrine organs, and other organs. These are the central pacemaker sensors, but there are peripheral sensors as well.
Feeding can trigger sensors in the kidney and liver.
Sleep is regulated by a combination of the rhythm of the blood pressure and postural changes that are connected to sympathetic/parasympathetic vagal system.
Disruption of sleep, artificial light, travel across time zones, and shift work can create a setup for a variety of diseases. A serious disruption occurs in blind people. Even the one hour change in the “spring forward” causes a variety of diseases including an increase in heart attacks and impaired performance creating increase in car accidents.
These issues are aggravated by blue light emitted from electronic devices and can affect melatonin levels which are integral in allowing proper sleep patterns. NO BLUE LIGHTS IN THE BEDROOM.
Neurodegenerative disorders are especially prone to disruption of sleep wake cycles (Alzheimer’s, Parkinson’s disease, etc.) and in certain psychiatric disorders such as schizophrenia, bipolar disorder, depression, seasonal behavior disorders, etc. Antidepressants target the circadian cycle that influence the dopamine, nor-epinephrine neuroreceptor system.
Even cancer in some ways is connected to the circadian cycle system and diseases caused by inflammatory diseases, emitting more cytokines in the morning which accumulate at nighttime. Cardiovascular and clotting diseases are inflammatory in origin influencing clotting factors (more heart attacks at night from platelet clumping, release of clotting factors, etc. to increase these events). Even cardiac arrhythmias occur more often during the day when catecholamines are released more readily.
Abnormal drop in blood pressure during the night increases risk for strokes.
Feeding at abnormal times can increase insulin resistance and abnormal lipid disorders. Impaired glucose metabolism can interfere with the circadian rhythm as well.
Much research is ongoing with these circadian rhythm disorders and how they affect disease and have led to many recommendations of when to take certain medications such as aspirin and statins at night.
NEJM, Feb. 11, 2021
Colorectal screening guidelines
The guidelines for beginning screening for colorectal cancer was changed from 50 to 45 by the American Cancer society several years ago, when I was privileged to be on the cancer guidelines committee to analyze the data to change the age for general screening from 50 to 45 years of age, primarily because a significant number of individuals before age 50 with COLON cancer and at a later stage. This is because the diagnosis was delayed because screening was not recommended and Medicare and other insurance companies would not pay for earlier screening. CA Cancer J Clin 2018, 68:250
The U.S.P.S.T.F. finally came up to speed with other medical organizations and the ACS by recommending the switch from 50 years of age to 45. The influence of this federal advisory committee has great influence on insurance companies, therefore, more coverage will come with this change.
The task force also felt that screening should continue to age 85 instead of 75, however, it confers little advantage if the individual has had negative results on previous colonoscopies. Over 86, they consider it to be of no value.
Keep in mind, this screening is for asymptomatic individuals with no family history of colorectal cancer. They recommend screening be performed using a wide variety of tests:
a) direct visualization—
CT colography (every 5 years)
Colonoscopy (every 10 years)
Flexible sigmoidoscopy (every 5 years)
b) stool based tests
FOBT (fecal occult blood tests)---every year
FIT (fecal immunochemical tests)---every 1-3 years
c) stool DNA tests (Cologuard)---every 3 years
NEJM, Journal Watch June 15, 2021
Family history of colon polyps and increased risk of colorectal cancer (CRC)
Families with a history of colon polyps confer an increased risk of colorectal cancer from a new study of 68,000 people in Swedish national registries with CRC with 330,000 matched controls. People with a hereditary colorectal cancer syndromes, and histories of inflammatory bowel disease were excluded as they have higher risk.
Being diagnosed with colon polyps before age 50 was a strong factor and conferred an even higher risk.
Knowing a person’s family history has never been more important as genetic markers are being discovered often in cancers. If a first degree relative has a history of colon polyps and or younger relatives have this history, screening should begin earlier. This study came out before the above revised screening guidelines, and recommended screening begin before 50. The time for screening should certainly switch to 45, and even earlier if the family history is strong.
BMJ*, 2021, May 4; 373 *British Medical Journal
That completes the October, 2021 report. Enjoy the leaves.
Next month, the November report will include:
1. Further updates on COVID-19
2. shorter courses of antibiotics may be just as good
3. Veggie and fruit capsules-hype or help?
4. Brain fog from COVID to chemotherapy-review
5. FDA wants menthol out of cigarettes
6. growing up in Foster Homes
Stay healthy and well, my friends, and be nice to one another!! Dr.Sam