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Statins: A Critical Appraisal

May 9, 2023 Philip Miller Comments 1 comment

You can find a number of well written books with articulate statistical analyses over the years questioning the results of statin therapy. What is the true value and efficacy of statins (HMG-CoA reductase inhibitors) in treating and preventing heart disease? The statistics can be overwhelming. What is the real risk benefit ratio?

Lipids and the Emergence of Statin Therapy

Lipid research actually started sometime in the early 1920’s. It gained more momentum in the 1950’s with John Gofman at the Laurence Radiation Lab in Berkeley. Then the interest waned, so the field languished for another few decades. John Gofman turned his energies to examining and warning us of the dangers of constant low level radiation therapy

In the 1950’s and 1960’s the cholesterol theory was gaining more adherents. Anyone over 50-60 remembers well the exhortation to eat less fat. No eggs. Skimmed milk. Substitute margarine for butter. It was much healthier. Cholesterol was bad. Turns out margarine is literally the bottom of the barrel stuff. Highly hydrogenated oils. Much less healthy. Personally, I never believed the cholesterol theory even in Medical School and was labeled a heretic. “Dummy, everyone believes the cholesterol story.”

One of the most erudite and gentlemanly Professors at UCSD Medical School was Dr. Daniel Steinberg, a prominent lipid researcher. He wrote a wonderful book The Cholesterol Wars which is one of the best historical accounts of the lipid research over the past 80 years. He even admits “we almost lost the cholesterol debate if it had not been for the emergence of Statins.”

The Framingham Study was a large study begun about 45 years ago in a small town outside of Boston where a majority of the population has been studied annually. It is the best cross sectional study we have.

Interestingly, even the Framingham study proved that cholesterol is a bad predictor of heart disease. 50% of those who suffered heart attacks had totally “normal” cholesterol levels. By the way, the term “normal” is a moving target and subject to standards committee declarations. There is no “normal” cholesterol, only declared “acceptable levels.” A GP, an internist or a cardiologist will have different and increasingly aggressive definitions of “normal.”

Association vs causality is an ancient debate which is not well settled. Aristotle proposed four postulates for causality. Many centuries later, David Hume, the great Scottish Enlightenment philosopher expounded about this in detail.

Cholesterol does not cause heart disease. …

The Pandemic of Fear

October 18, 2020 Philip Miller Comments 2 comments

The Pandemic of Fear

So here we are 10 months into a worldwide pandemic. How are we doing? How was public policy formulated? How is it being implemented today? We can be ruled by fear or we can be ruled by reason and example. Fear is the coinage and watchword today. Fear destroys our capacity for critical and rational thinking and decision-making. You know the old expression, “I was so nervous I couldn’t think straight.” That is where we are today. Pursuing The Middle Path.

My pick for one of the all-time great football coaches was Bill Walsh of the 1980’s 49ers. He always scripted the first 15 plays. Everything by the book for the first 15 plays. Then he would reassess based the opposing team’s read and creative reaction. Reassess, call new plays based on today’s game. Here is where we are today. However we got here, despite all missteps, what do we do now going forward?

When I hear politicians say, “let’s follow the science” I say ridiculous. There is no such thing as “the science.” Science is a messy affair. Science is a method of inquiry and derivation of truth in the world. Science is the alternative to myth, superstition and belief. It is a matter of developing hypotheses testing all possibilities, including counterintuitive possibilities and deriving conclusions based on the results of rigorous testing.

Dissenting viewpoints

There is a definite air of medical arrogance from Dr. Fauci and the CDC. This has not been a fair and open debate. Dissenting views and approaches have been censored and arrogantly dismissed. We shun the courageously crafted Swedish approach.

My glimmer of hope is the Great Barrington Declaration. You should fully read this statement by three highly respected academic epidemiologists.

Dr. Martin Kulldorff, professor of medicine at Harvard University, a biostatistician, and epidemiologist with expertise in detecting and monitoring infectious disease outbreaks and vaccine safety evaluations.

Dr. Sunetra Gupta, professor at Oxford University, an epidemiologist with expertise in immunology, vaccine development, and mathematical modeling of infectious diseases.

Dr. Jay Bhattacharya, professor at Stanford University Medical School, a physician, epidemiologist, health economist, and public health policy expert focusing on infectious diseases and vulnerable populations.

We will return to this in a minute.

The Total Picture

So it is time for reassessment. What we are doing is not comprehensive. We are not looking at the total picture. It is a series of fitful and reactive decisions. It started with unrealistic and wildly pessimistic assumptions from Prof Neil Ferguson of Imperial College. We have not anticipated the unintended consequences — the collateral damage. As I have said from the very beginning:

The fallout from our decisions and public policy will dwarf the virus.

Please watch my Covid 19 video. From beginning to end. You cannot scan it.

Bottom line. Highly communicable. Low virulence. Please understand this. It is not about “cases.” That is the daily drone.

Contrary to what you hear, this is not the worst pandemic in our lifetime. AIDS has claimed the lives of 35,000,000 people worldwide. 1,000,000 people die of tuberculosis, worldwide every year. More people, and especially teenagers, have taken their lives in suicide since the beginning of this pandemic. Watch Childhood 2.0. Most hospitals are actually underutilized not over utilized. Cancer diagnoses, treatment and elective surgeries are being subordinated and delayed. Homelessness is on the rise. Airline travel down 90%. And the entire restaurant business endangered.

There is a Middle Way

What do we know about this virus? Quite a bit. But it eludes public policy. And it has degenerated into hopeless hyper-political hyperbolic rhetoric. If you are on the Blue Team, you are all for masks and severe restrictions. Protect me at all costs. If you are on the Red Team you don’t believe in masks or restrictions. “Don’t tread on me.”

So here is the first problem. So much of today’s discussion and debate is a series of binary choices. It’s Pink Floyd’s Us or Them.

Us (us, us, us, us) and them (them, them, them, them)
And after all we’re only ordinary men
Me
And you (you, you, you)
God only knows
It’s not what we would choose (choose, choose) to do (to do, to do)

Carl Sagan, in his wonderful book the The Demon Haunted World:Science as a Candle in the Dark lays out a series of logical propositions. In Chapter 12: Baloney Detection he talks about the excluded middle or false dichotomy – considering only 2 extremes in a continuum of intermediate possibilities. We are looking for simple answers. Science is more messy. It takes time. It takes testing. Thesis, antithesis, synthesis.

The most salient warning Carl Sagan gave us:

Arguments from authorities carry little weight – “authorities” have made mistakes in the past. They will do so again in the future. Perhaps a better way to say it is that in science there are no authorities; at most, there are experts.

And, finally, watch this a stunning interview with WHO special envoy, Dr. David Nabarro. He was former Special Adviser to the United Nations Secretary-General on the 2030 Agenda for Sustainable Development and Climate Change; He is now advocating the Middle Way. A more sustainable path that avoids all the economic strife and dislocation that we have been suffering.

We need to change course! Lock-downs do not work. It only amplifies human suffering.

Are Masks Protective?

If you will remember early during this pandemic there was a raging debate about the shortage of ventilators. Do you hear this plea or argument any longer? No. Then you were hearing a cry for PPE – personal protective equipment. Masks and other garments. There was a unholy shortage. Why? And then there was no longer shortage. In fact, probably a surplus. So what is the actual science of masks? This can become quite technical. And we can talk about the finer points of aerosolization, micro-droplet size, and N95 masks etc.

In the end, there is no good definitive scientific evidence that masks are fully protective. It is just another assertion.

If masks are fully protective, then why do we need to wear masks and socially distance at the same time? Why are health workers still contracting Covid 19 if they are fully protected by masks and gowns and gloves?

Sidewalk cafe without masks — A mixed message

If masks are fully protective why do we walk down the street wearing a mask, but alongside is a row of restaurant tables with people not wearing masks? Since you cannot wear a mask while eating. In other words, worry about the virus in one lane, but not in the adjacent Lane.

Masks have become overly politicized. Another example of the Blue Team promotes masks. The Red Team shuns masks.

The best you can say, in the end, is masks have some utility. That’s it. That is a qualitative and not a quantitative statement. It is better than nothing. Let me repeat. It’s better than nothing.

You see people wearing masks in the center of a field. You see people wearing masks driving around in cars.

Most unfortunately, masks have become a scarlet letter. Subject to vitriolic and self-righteous indignation. Why is it that person not wearing a mask? He is a super spreader. There is a self-righteousness that supersedes rationality.

Back to the Future – The Middle Way

Just to round out this story line read How to Survive a Pandemic by Michael McGregor. Among other voluminous sources he cites the former WHO Director of Communicable Disease Surveillance Response,

history has told is that no one can stop a pandemic.

Is this true or not?

Further, he quotes,

but experts feel that not only would quarantines be wholly impractical and ineffective, they would make matters worse.

To which I fully agree.

The World Health Organization recommends against such measures, in part, given the impracticality of enforcement.

Amplifying Dr. Nabarro’s recent WHO statement and interview.

And finally, he quotes

following the 1916 polio epidemic in New York City, the head of the health department wrote that given the “countless instances of inconvenience, hardship, yes real brutal inhumanity which resulted from the application of the general quarantine, it was no wonder that so many people developed a real and most perverse ingenuity in discovering automobile detours.”

The point of McGregor’s book is, this pandemic is a dress rehearsal for a future pandemics of much more serious proportions involving the H5N1 flu virus. Really? Whoa!

So What Can You Do Now?

All disease is a host response. It’s not the virus as much as how you respond. It’s up to you to enhance your own internal health, well being and immune vigilance. This simple suggestion and admonition is so sadly missing from current public debate and policy enforcement. This is about personal responsibility and action.

The Warp speed Vaccine is not going to stop this pandemic. It is not going to save you. Remdesivir is not saving lives. Flu vaccines do not save lives.

In fact, kind reader, if you have read this so far, your chances of contracting serious illness from this virus is vanishing small.

Isolating kids from the pandemic is unnecessary — This is insane

This is not a pandemic of childhood or younger adults. Send all children back to school immediately. Open up all restaurants and travel.

Reason (his pen name) suggests in this weeks FightAging.org Covid-19 as a disease of aging.

Stop all these country to country and state to state restrictions. We are going to have to learn to co-exist with this virus. It is like a wild land forest fire. Fire fighters know a simple fact. All they can do is contain a massive fire. Only nature eventually stops and ends massive wild land fires. So too with massive world wide pandemics.

Turn off the news. It’s no longer news. It’s groundhog day over and over. 7-8 hours sleep. Get some fresh air. Some exercise. You can safely visit your friends, children and grand kids.

Daily immune enhancement:

Vitamin D 5000-10,000 units daily
Zinc 30 mg daily
Selenium 200 mcg daily
High quality protein

And finally don’t buy into the frenzy of widespread media sensationalized fear. Strive for courageous and kind actions.

Philip Lee Miller, MD
Carmel, CA Oct 2020

CoronaVirus: The Unintended Consequences

April 4, 2020 Philip Miller Comments 2 comments

The Set-up

CoronaVirus aka SARS-CoV-2 aka Covid-19. It has become everything. It has consumed our daily lives. The constant daily, nay hourly, haranguing of “breaking news.” The media talks about nothing else. As if life had stopped. I want to give you a different view and projection. A medical / epidemiologic / economic view. A more global and comprehensive take. The view from 10,000 feet as it were. This is going to be a longer blog.

This Virus is Striking High Density Cities

Is there a Middle Path? We know the stories about China, Italy, and now the United States. When in reality, statistical analysis tells a more sophisticated story. It is never black-and-white. In China 80% of all cases were in the city of Wuhan – Hubei Province. Virtually no cases in Beijing or in Shanghai. In Italy the vast majority of cases were confined to Lombardi. And now the United States, the vast majority of cases are confined to New York City. What is common to all of these? High density populations. In fact, there is a paucity of cases and fatalities in the entire Southern Hemisphere.

Background Resources and Historical Perspective

I want to give you more specifics about this CoronaVirus with a list of resources and technical details. This is a variant of the CoronaVirus group which has been well studied since the 1960’s. It is not new. The current mutation is the Novel CoronaVirus, SARS-CoV-2. The disease caused by this virus is Covid-19. Do you remember the SARS and MERS epidemics? Sudden Acute Respiratory Syndrome.

Let’s revisit my previous blog by putting this in proper historical perspective. This pandemic is here. It is worldwide. It is real. It has been predicted. But we must see it in perspective. Because you are being overwhelmed and I want you to see some daylight and hope.

This is not to ignore or in any way diminish the current suffering or stresses on our health delivery systems. But the world has suffered from far greater pandemics and plagues in the past. Watch this brief YouTube video from South Front – a necessary overview. You can barely see Covid-19 in this graphic. It’s like comparing Mercury to the Sun. You will have a difficult time even finding Covid-19 in this graphic.

Now look at another fine series from The VisualCapitalist worth bookmarking. It illustrates the same. Just how massive previous pandemics and plagues have engulfed the world.

And here is an up-to-the-minute link for real-time stats from WorldOMeter.

Finally, another long video graphically detailing the apocalyptic Spanish flu of 1918, following the end of World War I. It was a time of massive troop movements between America and Europe associated with widespread poverty and the devastation of war throughout Europe.

Why am I showing you all the videos links? To give you a sense of how pervasive and absolutely devastating prior pandemics were.

So why are we so fearful? How did we become so subordinated, freaked out and frantic over this current pandemic, as opposed to previous pandemics that were manifestly larger and more deadly?

Because we are overwhelmed with a sense of the unknown. Heightened by a pervasive media and social amplification. We are developing an entirely new lexicon. Newspeak. Social distancing. Shelter-in-place. We want zero risk in our daily lives.

The Bottom line: this is still a minor pandemic compared to the Black Death Plague of 1348, or the Spanish Flu Pandemic of 1918, and even more recent epidemics such as the cumulative deaths worldwide from HIV/AIDS.

What Exactly is this CoronaVirus – SARS-CoV-2?

SARS-CoV-2 originates from an animal vector – bats. We suspect it travels to Pangolins whose scales are prized in Traditional Chinese Medicine. Then humans are infected. That seems to be characteristic of so many modern flu-like and viral pandemics. Jumping from an animal reservoir to humans. Like swine flu, bird flu, SARS (civet cats), MERS (camels) and now Covid-19.

We know that this virus spreads rapidly. Scientifically and epidemiologically we look at R₀ values, how many people are infected by a single person. In other words, its multiplication factor. The ideal is R₀= 1. That flattens the curve. The current R₀ is assumed to be about 2.5. But these numbers are estimates, subject to complex differential mathematical models. We do not know how accurate these models are.

80% of all cases are considered mild cases. That is the source of herd immunity. Let me return to this concept later.

This may be a sidebar but highly recommended. If you really want to know the science beyond the headlines here is the best lecture series I have seen. He explains and shows you all aspects of this viral origin and pandemic spread. It is produced by Ninja Nerds, an unlikely face of academic knowledge. But if you watch this Ninja Nerds series on Covid-19 you will learn everything you need to know about the epidemiology and the pathology of this virus. You will be well schooled after finishing this series.

Controversies in Containment Strategies

I always look at the outliers. Why are there so few cases in India, Australia, Africa, South America, and Scandinavia? And why the differences in approach? We are told the approach in China and in Korea was draconian. Cell phones were being monitored. And yet look at this recent story showing Korea did not shut down their entire economy like we have.

from NPR news:

How South Korea Reined In The Outbreak Without Shutting Everything Down

“We’ve seen examples in places like Singapore and [South] Korea, where governments haven’t had to shut everything down,” said Mike Ryan, head of the World Health Organization’s Health Emergencies Programme. “They’ve been able to make tactical decisions regarding schools, tactical decisions regarding movements, and been able to move forward without some of the draconian measures.”

An article in Science:

Mathematics of life and death: How disease models shape national shutdowns and other pandemic policies

“Long lockdowns to slow a disease can also have catastrophic economic impacts that may themselves affect public health. “It’s a three-way tussle,” Leung says, “between protecting health, protecting the economy, and protecting people’s well-being and emotional health.”

“I’m not really sure whether the theoretical models will play out in real life.” And it’s dangerous for politicians to trust models that claim to show how a little-studied virus can be kept in check, says Harvard University epidemiologist William Hanage. “It’s like, you’ve decided you’ve got to ride a tiger,” he says, “except you don’t know where the tiger is, how big it is, or how many tigers there actually are.”

And more from the New York Times. Dr. Katz is president of True Health Initiative and the founding director of the Yale-Griffin Prevention Research Center.

Is Our Fight Against CoronaVirus Worse Than the Disease?

“So long as we were protecting the truly vulnerable, a sense of calm could be restored to society. Just as important, society as a whole could develop natural herd immunity to the virus. The vast majority of people would develop mild CoronaVirus infections, while medical resources could focus on those who fell critically ill…

A pivot right now from trying to protect all people to focusing on the most vulnerable remains entirely plausible. With each passing day, however, it becomes more difficult. The path we are on may well lead to un-contained viral contagion and monumental collateral damage to our society and economy. A more surgical approach is what we need.”

If you are still with me, you will find this YouTube with Dr. Jay Bhattacharya, professor of medicine at Stanford University most enlightening. Subsequent to his editorial in the Wall Street Journal. He is asking the right questions. Is our draconian approach based on faulty assumptions?

Sweden and Holland have taken a different approach. What I call the middle path. Isolate and quarantine known cases. That is what is traditionally done. That is how you treat infected patients in a hospital. Isolate and contain.

Adverse Consequences of Flattening the Curve

What has been missing in the United States is the mobilization of a centralized strategic plan. It was all in place. Now we have a patchwork of federalized responses. These are tactics, with states scrambling for limited resources. This is not a strategic plan, which flows from a designated and recognized incident commander. What we used to call a Czar. One who directs and executes the strategic plan.

Dr. Anthony Fauci is a vaunted virologist and epidemiologist. Epidemiologists are not policymakers. He should not be the face of this pandemic.

There are some very sophisticated models of viral spread based on R₀ values. This is illustrated below, with an animated graphic. Here is the link the more interactive dynamic graphic model. Please take the time to play with the interactive graph for a few minutes.

If you look at this model of increasing isolation (shelter in place) 3 critical questions arise. What is the goal?

Reduce all cases – incidence?
Reduce and mitigate hospitalizations and stress on our entire EMS system?
Reduce and mitigate fatalities — mortality rate?

Containment Time line — Containment Duration — Light color is incidence, medium color is hospitalizations, dark color is fatalities

The answer to each of these questions might lead to entirely different strategic plans.

The incidence decreases the most. Then you see a decrease in hospitalizations. But the mortality rate decreases the least.

Our Ultimate Goal in Increasing Herd Immunity

As counter-intuitive as this may appear, decreasing the case incident rate may have negative consequences. Our goal with natural wild type immunity antibody production vs. acquired immunity through vaccination programs is to increase “herd immunity.” That is, increase the greatest number of people who have been exposed to a virus and are now immune. They can no longer spread the disease to other people. It is a firebreak. The current policy of “dampening the curve” actually diminishes herd immunity. In the long run, that is the real goal. That is what prevents the spread – enhancing herd immunity.

Dampening the curve will lower the incidence of new cases, lower hospitalizations, and slightly lower fatalities. But lengthening this curve is at the expense of prolonging economic and financial distress. That is the key concept. That is why you are seeing Congress hurriedly passing historic and unimaginable emergency legislation. Remember Andrew Yang’s promise to give us each $1000? How ridiculous that sounded? Here we are.

What is missing from these epidemiologic models is a balance between containing the viral spread and prolonging economic dislocation and total financial/economic collapse.

The Economic Fallout will Dwarf the Medical Tragedies

We will see a rise in unemployment to historic levels. Look at this graphic representation of the most precipitous DJIA slide in the stock market in history. Even if you have no interest in the stock market or have nothing invested, it is an indicator of financial distress and a prediction of economic calamity.

The more important statistic is the VIX indicator. The VIX is a measure of volatility — of panic. And this level is equal to or greater than 2008. It is a perfect storm with other indicators that I will leave to later.

What is the point? It is a plea for a middle path. What is the least amount of time of widespread quarantining vs. a disastrous total shutdown of local commerce, business and economic vitality? This cannot go on much longer. So many small businesses will fail as unemployment figures skyrocket.

This will exceed our experience of 2008. The economic consequences will eventually dwarf the medical consequences.

Prevention, Treatment, and Therapeutics

This is what all my patients are asking. What can I do for prevention? What can I do if I become sick?

The most important set of preventatives is concentrating on your optimal health and immune support. 7 to 8 hours of sleep daily. Some degree of day exercise. Healthy eating. Decreasing carbohydrate intake. Increase in your protein intake. A good nutritional supplement program. This includes adequate a quality multivitamin, Vitamin D, Vitamin K, extra selenium, extra zinc, and a good probiotic at the very least. All my patients are taking much more. as part of a robust daily routine.

Good hormonal balance, which includes optimal thyroid balance. Thyroid is the seat of your immunity.

I am not convinced that wearing masks are effective. The most effective N95 masks are in short supply and should be saved for medical workers. Washing hands and possibly wearing surgical gloves may be beneficial. I have always been wary of ATM pin pads and handle bars on shopping carts. These are simple precautions that are easy and beneficial. Avoiding all possible contaminated surfaces.

I now recommend stop watching the news! It is no longer healthy, educational or informative. You will see your stress levels fall immediately. Watch all your old favorite movies or all those new ones you have not seen yet. Read more. Take the time to do those things you have been putting off for years.

There is no definitive drug treatment for this virus except for pulmonary support, fluid resuscitation, and some possible advanced therapies directed to the loss of alveolar surfactant and accumulation of alveolar consolidation.

Many of you have asked me about the combination of Chloroquine and Azithromycin. There have been very limited studies that show some promise. But these are more anecdotal. Although I personally favor empirical approaches to medical problem solving, I do not support the use of these drugs for casual and unsupervised use. This combination should be limited for very sick hospitalized patients.

There are a number of problems with Chloroquine. Hydroxychloroquine (Plaquenil) is less toxic than Chloroquine. And in the mad rush to sequester and hoard Chloroquine or Hydroxychloroquine you are stealing vital medications from patients with advanced rheumatoid arthritis, lupus, scleroderma, or CREST syndrome who rely on these drugs for their significant disease modifying benefit.

And by the way, behind the scenes, there are conflicting policy decrees. The CDC is trying to approve “off label” use of Chloroquine and Azithromycin for life-threatening disease. On the other hand, the Medical Board of California has issued warnings that physicians using these drugs off label are being warned. We do not know whether that includes sanctions or some other bureaucratic intervention. It all muddies the waters further.

It is very interesting that in the medical profession, we have been chided for the last 20-30 years not to use antibiotics for viral syndromes. The standard dogma is “antibiotics do not treat viruses.” And yet the addition of Azithromycin is now being advocated as an adjunct. There are some theoretical aspects of Azithromycin and Chloroquine enhancing zinc absorption which enhances antiviral activity.

There is also a theoretical discussion in medical journals regarding the potentially harmful effect of ACE inhibitors and ACE blockers. This would include Lisinopril, Vasotec, Cozaar (Losartan), and Valsartan (Diovan) to name a few. It is postulated that the CoronaVirus attaches to ACE2 receptors facilitating viral penetration and cellular infection. This ultimate effect of this mechanism is an unknown at this time. But you may hear various discussions regarding this mode of activity. Do not stop these anti-hypertensives.

I fall back on my anti-viral routine which has been successful in the past. At the very first sign of any viral infection. I highly recommend:

Vitamin D 50,000 units for five days.
Astragalus 1000 mg daily for five days.
Thymic protein A (Pro boost) 2 packets 3 times daily for 5 days

Now having made that recommendation, I am seeing major backorders for virtually all nutritional supplements and most especially, zinc, Astragalus and Pro boost. My recommendations still stands as soon as they are available.

In Summary:

It did not have to be this draconian. So many missteps and failures of leadership. But here we are.

One more quote from Max Brooks, son of the great Mel Brooks and Author of World War Z :

I think right now we have to be so careful about who we listen to, because panic can spread much faster than a virus. And I think in addition to social distancing, we have to practice good fact hygiene.

Take care of your own health. Don’t watch the news any longer. Watch great movies. Be with your family. Read my past blogs on nutritional routines. Support clear thinkers. You will be OK.

Send me a list of your favorite movies or books. Every one will have their own. If enough people respond I will publish later.

For sure another CoronaVirus blog will follow soon.

Philip Lee Miller, MD
Carmel, CA
April 2020

Influenza and CoronaVirus: A Thoughtful Response

March 3, 2020 Philip Miller Comments 1 comment

How should you respond to the spread of the Coronavirus? Renamed COVID-19. What is the most rational and sane response? Should we close off all the borders? Should we cancel all conferences and outdoor events? Should we cancel the Olympics? What is the real prevalence and mortality rate? The answer: this is a time for vigilance, preparation, with calmness.

This is your grand sweep of time overview. This series will be updated as this is a fast moving story.

CoronaVirus Requires Organized Incident Command

Great leaders exhibit calmness and reassurance while at the same time exhibiting the qualities of a effective incident commander. That is how massive wild land fires are fought. An incident commander is identified and the command structure is assembled. Plans are coordinated and executed purposefully with determination.

So the problem with the Coronavirus is the fear of the unknown. In the end this will portend far greater economic, commercial and societal consequences than epidemiologic or medical outcomes. We have already seen a precipitous fall in the stock market, amounting to $5 trillion ($5,000,000,000,000) in paper losses. It will rebound, but will fall again.

We should heed the words of Franklin Delano Roosevelt. The only thing we have to fear is fear itself. You will not die. You simply need to take modest precautions.

Disease Outbreaks — Four Horseman of the Apocalypse

We are always faced with the Malthusian Four Horsemen of the Apocalypse. War, famine, pestilence and disease. They will never fully disappear.

Throughout all of human history we have witnessed great epidemiologic challenges and disasters. Leprosy, tuberculosis, the plague (the Black Death), smallpox, the pandemic flu of 1918, AIDS, SARS, swine flu, MERS, Ebola virus and now Coronavirus. It will never end.

There were numerous recurrences of the plague through out the middle ages. The worst in 1348 where an estimated 40% of population throughout Europe succumbed. That must have seemed like the end of the world. It was centuries before the germ theory of contagious disease. No one knew the source. So there were religious incantations. There were whole groups who were shunned or dispossessed. And then it stopped.

Half of Paris’s population of 100,000 people died. In Italy, the population of Florence was reduced from 110,000–120,000 inhabitants in 1338 down to 50,000 in 1351. At least 60% of the population of Hamburg and Bremen perished,^[81] and a similar percentage of Londoners may have died from the disease as well.^[67] In London approximately 62,000 people died between 1346 and 1353.^[19] — Wikipedia

During the Spanish flu Pandemic of 1918, it is estimated that nearly 1/3 of the world’s population contracted the flu. More than 500,000,000 people. It followed the end of WWI, with mass troop movements. With massive shifts in human populations. The flu actually lasted 2 years. There was a ping-pong effect between America and Europe. The stories are legion of physicians working around the clock, tending to patients without antibiotics or antivirals as we have today. That also was a draconian period of time.

But we survived.

Annual Influenza Review

Each year I compose a blog detailing the ineffectiveness of the influenza vaccine, because the flu mutates each year. The vaccine is always based on last year’s virus. It is always a guess. Effectiveness varies between 10-60%. But a more detailed look at vaccine effectiveness shows a distinct stratification according to age. Where the effectiveness of the vaccine is even dramatically less in older and frail individuals. That is why we are now giving triple or quadruple strength vaccines to older individuals.

And currently the number of fatalities from the flu, even this year, far exceeds the Coronavirus. But the flu has become displaced as the topic du jour.

CoronaVirus in Perspective

Even last week a more detailed look at the viral spread in China is quite revealing. At least 80% of all cases originated in one province. From Wuhan. Virtually no fatal cases in Shanghai or Beijing. High density populations where you expect higher incident and mortality rates. You never hear about this. And with draconian infection control the rate of spread is beginning to diminish.It’s interesting a whistleblowers complaint about known Coronavirus patients disembarking from a ship in Vallejo may have been the source of the recent death. But what about all of the unprotected team members who were sent home? As far as we know none of these have succumbed.

In the end all viral and bacterial infections are a host response. If you are healthy and vigorous, your chances of contracting any illness are diminished. Those that are older and frail are more subject to pneumonia and perishing.

I am not reassured by the current administration’s haphazard and amateurish approach. This appears to be a Keystone Cops approach. There are some stars. Dr. Anthony Fauci is highly respected at the CDC.

Treatment Modalities

So here are my annual recommendations.

These were formulated for the flu but may pertain to the Coronavirus. Influenza vaccines are ineffective. Anti-virals such as Tamiflu and Relenza have immediate value if taken within the first 48 hours.

My recommendations each year are effective. [Although the usual FDA disclaimers for advocating treatment therapies are acknowledged.]

At the first sign of the flu or any viral syndrome:

50,000 units of vitamin D daily for 5 days.
Astragalus 1000 mg daily for 5 days.
Thymic protein A (ProBoost) 1-2 packets 3 times daily for 5 days.

The effectiveness of vitamin D against viral syndromes is well demonstrated. Similarly should there be any doubt of high dose vitamin effectiveness, the only known cure for severe life-threatening measles is – vitamin A.

Wash your hands. As Ignaz Semmelweis demonstrated in the mid 19^th century, washing the hands prevents dissemination of disease. He was able to decrease the rate of postpartum death (Puerperal Sepsis) from 40% to 1% simply by washing hands (in carbolic acid).

Stay calm. Get plenty of rest and sleep. Don’t panic.

Let me know your own observations.

Philip Lee Miller, MD

Carmel CA

March 3, 2020

Telomeres, Telomerase and Senolytics

October 21, 2019 Philip Miller Comments 1 comment

Telomeres, telomerase and senolytics is ushering in a new era of longevity medicine and vital health. These are exciting times.

In 1994 the first ever world conference on Anti-Aging Medicine was held in small “off the strip” hotel in Las Vegas. An exciting prospect under the auspices of American Academy on Anti-Aging Medicine (A4M). The goal of that time was to aggregate the best of medical science and information into a cohesive body of high-tech preventive medicine. With the aim of prolonging life and health span. It was a heady proposal with its share of critics. It was the beginning of a new paradigm.

So many terms have been used over the years, including Integrative Medicine, Complementary Medicine, Functional Medicine, Anti-Aging Medicine, Age Management Medicine and Longevity Medicine. They share one common goal. Improving optimal health and well-being and increasing a healthy lifespan — HealthSpan.

It is all based on optimizing physiological function and cellular health and vibrancy. Through the use of micronutrients, vitamins, minerals, hormone replacement therapy, rational and scientific approaches to exercise, our focus has always been directed toward a higher goal.

Nutritional Medicine Pioneers

There have been a series of widely acclaimed nutritional constructs. Starting with Nathan Pritikin and Julian Whitaker’s advocacy of complex carbohydrates, to Michael and Mary Eades advocacy of high-protein diets (Paleo), to Dean Ornish vegan diets, to low carbohydrate diets most successfully advocated by Robert Atkins. Enter David Asprey of Bulletproof fame with refinements and banner success. Each rock star has held center stage in their time.

So where are we today? The current consensus is a low carbohydrate, ketosis generating diet with healthy fat intake as the most beneficial pursuit. This can be elaborated elsewhere.

The Holy Grail throughout human history, has been the search for eternal youth and immortality. The Shangri-La effect. In the modern age, we have been seeking “the master controller” of aging. Does this exist? Is there one gene or one gene locus that controls aging? We are closer to some vital answers. And our efforts have increased dramatically in the last 20 years and even more so in the last 3 to 5 years.

We have shifted from Anti-aging Medicine to full Regenerative Medicine. What I term Anti-Aging 2.0. A shift from high-tech preventive medicine to truly regenerative therapies. Now what form does this take?

Epigenetics Controls our DNA

Since the discovery of the structure of DNA by Watson and Crick (which should have been Linus Pauling and Rosalind Franklin), we have all been inured in the concept that genetics controls everything. But are we slave to our genetics? The answer is no.

The concept of nature or nurture was used to explain why genetics is not the master arbiter. Or incomplete penetrance with age. But exciting re-thinking of genetics has led to the new field of Epigenetics.

We now know our DNA is merely a blueprint. A blueprint alone cannot build a house or skyscraper. Architects, general contractors and workers execute the master blueprint.

So the field of epigenetics is an effort to explain how various interactions and signaling processes turn on or off master genetic controllers or suppressors. And … who controls the controllers?

The most important concept to keep in mind is balance throughout our life. There is always the process of “blastic” vs. “clastic” activities. A blastic activity build muscle and bones whereas is “clastic” activities clear away old dead tissue. Our bones throughout life are constantly being remodeled. Hormones must be balanced.

This higher level of balance throughout life is delicately controlled by repressor or suppressor genes or expressive genes. As we age, this balance is subject to environmental and psychological stress, foods, EMF, chemicals, inflammation, oxidation and glycation. Such is our modern environment.

Telomeres and Telomerase Hold Great Promise

There are two highly innovative threads of exciting research and experimentation in small innovative groups. Telomeres and telomerase is based on the concept that our DNA loses ability to replicate at a cellular level because of frayed end caps. The telomeres. This explains the vaunted Hayflick limit — that cells cannot divide indefinitely.

Teleologically a specific gene (hTERT) controls the expression of telomerase that can repair these end caps by lengthening our telomeres. It is not normally expressed. It does seem to be expressed in high amounts in tumor cells, but not all. And it is expressed in the germ cell line — the immortal cells that we pass from generation to generation.

Senolytics — Clearing Senescent Zombie Cells

At the other end is a highly dedicated group of experimenters and researchers in the rapidly expanding field of senolytics and senescent medicine. Ergo the SENS project by Aubrey de Grey. Based on the concept that as we age, we accumulate more and more “zombie cells”. These are senescent cells that lose vital function, but “hang around” expressing inflammatory and potentially toxic influences.

If we could only clear these senescent cells, the current thinking is revitalization and growth of healthy, normal cells is enhanced. This is a simplified view worth expanding in later blogs.

Mayo Clinic Research with Dasatinib and Quercetin.

The Mayo Clinic has conducted seminal research and experiments with Dasatinib and Quercetin (D&Q) in mice studies showing significant repair of the aging process. Further work with senolytics has been carried out at the Buck Institute in Marin. Now we know there are additional Senolytic agents including Fisetin and Rapamycin. When used in small doses at infrequent intervals, experiments have shown either age regression or repair of aging effects.

Telomerase and Senolytics – A Unified View

The most elegant approach to synthesizing these major trends and pathways is to visualize a continuum. Combining the effects of telomeres, telomerase and senolysis.

Telomere shortening and effects with age

As we age, there is a critical time that no one has specifically identified where genomic instability is most critical. I think this is probably at age 50-60 years of age. At this critical juncture cells could be rejuvenated with telomerase inducers or senolytics, thereby preventing cancer progression and enhancing regeneration and rejuvenation. I want to thank Michael Fossel for the kind use of this most powerful graphic. His work at Telocyte is really exciting. Start by reading his latest book — The Telomerase Revolution. And even today more late breaking stories from Marie Blasco’s lab in Madrid

I am synthesizing this unified theory and vision of age regression and regenerative therapies. Can we now think about living to 120 or more? What are the challenges? You can start by reading the weekly blog by “Reason”: fightaging.org. Future blogs to expand this discussion in more detail.

Calling all seekers and discoverers. A video production will be available soon.

Philip Lee Miller, MD

Carmel, CA

Oct 2019

Migraine headache in postmenopausal women

Estrogen and Migraine Headaches

August 6, 2019 Philip Miller Comments 1 comment

Does estrogen benefit or exacerbate migraine headaches? Common knowledge in the medical literature is that estrogen may increase the frequency and severity of migraine headaches. This has not been our experience.

Estrogen is a vasodilator. And, therefore, should prevent the constricted phase of migraine headaches.

So let me tell you a clinical story. A 52-year-old postmenopausal female patient went to see her gynecologist. On pelvic ultrasound her endometrial (uterine lining) thickness was 4 mm. At her age a “normal” endometrial thickness is <4 mm. Anything greater > 4 mm is considered “thickened” and therefore some cause for concern. It is assumed that her age there is no hormonal stimulation of the endometrium. This requires an expanded discussion.

She was advised to stop her estradiol estrogen therapy. So she weaned herself off her estrogen over 1 to 2 weeks. But then began experiencing an increased frequency of migraine headaches. So much so that she began taking the anti-migraine medication, Imitrex, every day. Now the upper recommended frequency of Imitrex is no greater than 9 tablets monthly. That is because Imitrex is a vasoconstrictive that can cause significant systemic vascular ischemia — lack of oxygen delivery.

And sure enough she began to experience a rapid heart rate with some chest pain. She went to her local emergency room where she was diagnosed as a sudden and new case of atrial fibrillation. She was given some intravenous Diltiazem which should have slowed and reconverted her heart rhythm. This was unsuccessful after two doses. So the attending staff decided she should be cardioverted. This requires sedation and an electrical shock to the chest to convert the heart to a normal rhythm. She was then referred to a cardiologist for further workup.

Needless to say, a dreadful and “shocking” series of events. OK. Pun intended.

I have postulated over the last 25 years that the final common pathway of estrogen is choline production. Choline is vagotonic. That will slow the heart and increases normal and healthy secretions. During menopause estrogen levels decline and so do choline levels. The body reactively increases dopamine levels. This is what we call a sympathetic discharge. This is experienced as hot flashes, night sweats, nervousness, anxiety, cognitive difficulties, itching and in this case cardiac arrhythmias. All of these have been reported in postmenopausal women in their fifties.

We reinstituted her estradiol (Minivelle) patch, changing every 3 days to maintain consistent levels. And in this situation prescribed very low dose Inderal – a beta blocker.

The headaches have ceased. An unfortunate situation where estrogen withdrawal was ill advised leading to a series of rather distressing and significant consequences.

Lessons to be learned. Estradiol estrogen has over 400 vital functions.

Philip Lee Miller, MD
Carmel, CA
Aug 2019

Relative Risk vs Absolute Risk Reduction

May 26, 2019 Philip Miller Comments 2 comments

I have written often and spoken repeatedly to so many of my patients about relative versus absolute risk. This is so widespread in the medical literature, scientific literature and even in all advertising. I am always waiting for that “aha moment” when you understand how relative risk management is chicanery. It is used to sell you product. To amplify, inflate or conflate results.

I am prompted to write this blog by a recent meta-analysis published in JAMA Neurology May 13, 2019 with the title Frequency of Intracranial Hemorrhage With Low-Dose Aspirin in Individuals Without Symptomatic Cardiovascular Disease A Systematic Review and Meta-analysis. Sounds ominous, doesn’t it? Low-dose aspirin, increasing the risk of brain hemorrhage? Especially to all of you are using low-dose aspirin (81 mg) as a preventive measure.

In June 2015, I had previously published on my own analysis of all the major statin studies showing negligible benefit. So let’s expand upon this discussion. Let me bombard you with numerous examples.

Analyzing Statin Studies and Efficacy

My favorite reference is Calculated Risks by Gerd Gigerenzer. This is such a powerful book. Simply stated and elegantly presented examples of the misuse of risk analysis, and other statistical games. Let me quote briefly from his analysis on use of Pravastatin — a commonly used statin for “prevention of cardiovascular disease.”

“Absolute risk reduction: the absolute risk reduction is the proportion of patients who die without treatment (placebo) minus those who die with treatment. Pravastatin reduces the number of people who died from 41 to 32 in 1000. That is the absolute risk reduction is 9 and 1000, which is 0.9%.

Relative risk reduction: the relative risk reduction is the absolute risk reduction divided by the proportion of patients who die without treatment. For the present data, the relative risk reduction is 9÷41, which is 22%. Thus, Pravastatin reduces the risk of dying by 22%

The relative risk reduction looks more impressive than absolute risk reduction. Relative risks are larger numbers than absolute risk and therefore suggest higher benefits than really exist. Absolute risks are a mind tool that makes the actual benefits more understandable. – Gerd Gigerenzer

This really drives the point home. Exactly as I had previously written.

Low Dose Aspirin and Intra-Cranial Hemorrhage

Now let’s look at the recent JAMA Neurology 2019 article.

I will quote the results showing relative risk ratios (RR). Hazard ratio (HR) is nearly the same measure often quoted. A RR or HR value of 1.5 = 50% increased risk. Either of these are the most commonly cited statistics in all the medical studies.

Here is an abstract of the results of the study. And so frequently that is all you will see and believe. Because most people, including even most physicians, will not read or analyze the paper. We are too busy.

RESULTS: The search identified 13 randomized clinical trials of low-dose aspirin use for primary prevention, enrolling 134,446 patients.

Pooling the results from the random-effects model showed that low-dose aspirin, compared with control, was associated with an increased risk of any intracranial bleeding (8 trials; relative risk, 1.37; 95%CI, 1.13-1.66; 2 additional intracranial hemorrhages in 1000 people), with potentially the greatest relative risk increase for subdural or extradural hemorrhage (4 trials; relative risk, 1.53; 95%CI, 1.08-2.18) and less for intracerebral hemorrhage and subarachnoid hemorrhage.

CONCLUSIONS AND RELEVANCE Among people without symptomatic cardiovascular disease, use of low-dose aspirin was associated with an overall increased risk of intracranial hemorrhage, and heightened risk of intracerebral hemorrhage for those of Asian race/ethnicity or people with a low body mass index. — Meng Lee et al

The key phrase here is overall increased risk.

So let me excerpt just one portion of data from the study to show you why the conclusion is inaccurate and essentially bogus. The true incidence was tiny. So relative comparisons are nearly meaningless.

Pay attention to the extreme right hand column, highlighted in yellow, which shows my added absolute risk. This column is absent from all medical papers.

Relative vs Absolute Risk Graphic

Now let me illustrate even more graphically. It is all dependent on the sample size and true incidence. What is the difference between relative and absolute risk or statistics with a sample size of 10, 100, or 1,000? It is the entire story. This first graphic shows a relative risk reduction of 50% across 3 sample sizes. The large yellow arrow shows an equal risk reduction across these sample sizes.

This is how they fool you. The relative risk reduction is independent of the sample size.

Now let’s look at the absolute risk reduction across these 3 sample sizes.

It should become much clearer. The absolute risk reduction (large yellow arrow) becomes almost invisible as the sample size increases. That is the take-home message today. Absolute risk reduction is entirely dependent on the sample size and incidence. It is also, incidentally, what is necessary to determine the “numbers needed to treat (NNT).” How large a sample size is necessary in order to arrive at meaningful results? To find at least one event.

Poor Medical Reporting

I had previously quoted work by the highly respected Douglas Altman, D.Sc., in a short editorial in JAMA 2002. Where he writes:

there is considerable evidence that many published reports of randomized controlled trials (RCTs) are poor or even wrong. Despite their clear importance. The results of several reviews of published trials briefly summarized in table 1. Poor methodology and reporting are widespread. — Douglas Altman, D.Sc.

He was such a tireless advocate of improving medical reporting, improving peer review and exposing the inadequacy of most published papers.

Two months months later in the Aug 2002 Scientific American, Benjamin Stix quoted this erudite statistician with his own comments on poor medical reporting. Essentially lambasting (or exhorting) the entire medical literature community

MEDICAL REPORTING
Only the Best

Advertising campaigns routinely hype the most flattering claims to sell their products. Evidently so do papers in medical journals. Researchers at the University of California at Davis School of Medicine found too much emphasis given to favorable statistics in five of the top medical journals: the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, the Annals of Internal Medicine and the BMJ. The study, which looked at 359 papers on randomized trials, found that most researchers furnish a statistic only for “relative risk reduction”–the percentage difference between the effect of the treatment and a placebo. Just 18 included the more straightforward absolute risk reduction. If a treatment reduced the absolute risk from, say, 4 to 1 percent, it appears more impressive to present only the relative reduction of 75 percent. Researchers also failed to show other statistics that provide a more nuanced picture of the results of clinical trials. The article is in the June 5 Journal of the American Medical Association.(full pdf) —Benjamin Stix [emphasis added for clarity – ed.]

Coda

Those of you who are followers of Dr. Peter Attia have also been treated to this same discussion of risk management, risk analysis, and poor statistical methodology.

So next time you read a headline — drug reduces risk 43%, a vitamin increases risk 14%, this car now accelerates 30% faster, or whatever, you will have a better appreciation of risk and performance.

“We won’t get fooled again” — The Who

Philip Lee Miller, MD

Carmel CA 93923

Cholesterol, triglycerides and heart disease

Is Cholesterol the Culprit?

December 10, 2018 Philip Miller Comments 4 comments

Probably as long as you can remember, cholesterol is “known” to be the cause of cardiovascular (heart and blood vessel) disease. Does dietary cholesterol cause heart disease? What about familial super high cholesterol? Does that cause heart disease? The short answer is – probably not. Let’s expand. I have written extensively on the subject in the past.

Cholesterol has been studied since the early 1900s. Initially in fits and starts. John Goffman studied cholesterol in the 1950s at Donner labs in Berkeley. There was no interest. So he turned to other pursuits. The cumulative effects of low level radiation. Lipid research picked up in the 1970′ and 80’s.

Remember, the admonition to limit your egg consumption consumption? Or fats? You should reduce fats to reduce your weight. We have now found it didn’t work. My good friend Dr. Ron Rothenberg famously quips, “cholesterol: found at the scene of the crime – not guilty.” How do we prove this assertion?

cholesterol: found at the scene of the crime – not guilty. — Dr. Ron Rothenberg

Rudolph Virchow in the 19^th century postulated that most human disease is a result of inflammation. Most especially cancer, but probably vascular disease as well. Later Sir Thomas Sydenham postulated, “a man is as old as his arteries.” So we have historical precedents for the cause of cardiovascular disease– inflammation.

“a man is as old as his arteries.” — Sir Thomas Syndenham

When I was young medical student, we looked at total cholesterol. Over time the entire picture has evolved with more and more refinements and “precision.” So we now look at LDL, HDL, and VLDL. These are actually lipoprotein carriers of cholesterol and not cholesterol itself. LDL cholesterol is transported to the heart initially for repair. HDL is the reverse cholesterol transport system carrying cholesterol away from the heart. This has come under more intensive scrutiny in the last few years.

Further refinements have followed, including Lp(a), LpPLA2, myeloperoxidase, hs-crp, homocysteine, uric acid, and now particle counts. Let me return to this in a minute.

The goal of conventional cardiologists is reducing LDL numbers to less than 100 mg/dl or for “at risk” patients – as low as 60-80 mg/dl. Does this make any difference?

Dr. Daniel Steinberg was one of the most notable researchers in lipidology while I was at UCSD School of Medicine. He wrote The Cholesterol Wars. A good read for its historical content. At one point, he notes, “we almost lost the battle until statins arrived.” Which implied that severe dietary restriction alone was insufficient to reduce cardiovascular morbidity and mortality. Statins were much more potent. We could lower LDL more aggressively. But is reduction of LDL successful? I contend not. Statins are anti-inflammatory. They do not work by simply lowering LDL levels as much as mitigating inflammation.

That is why statins may actually have the greatest effect and benefit surrounding the acute period of a myocardial infarction.

Berkeley Heart Lab (BHL) pioneered the concept of LDL particle sizing. This has drawn more recent attention and acclaim. BHL developed the notion of pattern typing using an expensive and laborious gel electrophoresis process. Which, in its day, superseded the expensive and neglected ultracentrifuges used by John Goffman. He had access to the warehoused ultracentrifuges that were originally designed to refine uranium during the super secret Manhattan Project at Berkeley Lawrence Lab and Sandia Labs.

Pattern A is characterized by low triglycerides, high HDL and large, fluffy LDL particles which are presumably less atherogenic. That is, they cause less vascular disease. A pattern B is characterized by high triglycerides, low HDL and small dense atherogenic LDL particles.

So we think particle sizing and LDL size may be a good marker of future pathology or disease. Again, large and fluffy LDL particles are less dangerous. Small dense LDL particles are far more pathogenic and atherogenic. This may be an impaired paradigm.

Dr. Robert Superko, co-founder of BHL, has been lecturing and advocating since the early 1990s on the danger and pathogenicity of Pattern B. He was aggressively trying to raise HDL and thereby lower heart disease with high dose Niacin. Empirically, we do see patients who have high HDL’s are at less risk. Unfortunately, therapeutic trials to increase HDL with niacin or experimental drugs (torcetrapib) have not been successful. I have often asked why is that? That may be the subject of a future blog. Milano A1 and HDL2b.

It is very likely we are missing or misinterpreting this picture. The real risk is high triglycerides which are carbohydrate induced, increasing the risk of diabetes and glycation. A series of events leads to increasing hemoglobin A1c levels (glycation), arterial stiffening, hypertension, and increased cardiovascular disease.

The most unfortunate, but glaring example was Tim Russert. He was known to have normal cholesterol but very high triglycerides. He died at the age of 58. Quite premature. What is the lesson here? Pattern B may be a biomarker for glycation because of its increase in triglycerides which are associated with higher carbohydrate intake. We see this as increased hemoglobin A1c levels.

Glycation is the end result of AGE products – Advanced Glycation End-Products. Which, by the way, was one of the postulates of my book the Life Extension Revolution: Growing Older without Aging.

Now let’s add another seriously overlooked cause of cardiovascular disease. Adhesion molecules. VCAM-1 is the most notable. Vascular Cell Adhesion Molecule. These adhesion molecules are highly active in cancer and in cardiovascular disease. It initiates a cascade of inflammatory responses where white cells and macrophages are drawn (recruited) into an inflammatory process forming arterial plaque. The end result of this inflammatory process is aggregated white blood cells and macrophages. That is soft plaque. This is, in essence, a pustular aggregation within the arterial wall. Somewhat like acne on the face, but rather in the intimal-medial aspect of your arteries.

Most unfortunately, Medicare and most insurance companies who follow suit, do not reimburse or recognize advanced cardiovascular risk factors. Most of the medical community does not see cardiovascular disease as an inflammatory process. We are stuck in an old paradigm that overindulgence of fat and cholesterol causes heart disease. There is no incentive economically or even medically to go beyond simple LDL measurements. Guideline derived, algorithmic medicine is short-circuiting our progress.

“without deviation from the norm, progress is not possible” – Frank Zappa

The real test of pathogenicity is imaging studies. Carotid intimal medial thickness (CMIT) measures arterial wall thickness and developing plaque. Superfast (EBT) CT scans (HeartScan) scores calcium load in your coronary (heart) arteries. Even a simple blood pressure measurement gives you valuable clues about arterial compliance and glycation. This is directly visualizing actual disease.

LDL and cholesterol is a bad predictor of eventual cardiovascular disease and events.

Empirically, I have seen this most vividly in specific cases. Extremely high familial LDL levels with entirely normal vascular studies. And extremely low LDLs associated with repeated coronary artery blockages requiring stents.

Now, I want you to read my detailed review of the major cholesterol studies that I published here in June 2015. This shows the results of all the major statin induced cholesterol lowering studies using absolute statistics and not relatives statistics. There was virtually no survival advantage on a population basis from statins. On an individual basis, there may be lives saved. But on a population wide basis there was no change. Totally contrary to what you have heard. What physicians believe or “know.” But it is based on rigorous statistical analysis using absolute and not relative statistics.

Bottom line: We need to change the paradigm.

We should be using new and more appropriate biomarkers for risk determination based on an inflammatory profile.

Triglycerides may be more pathogenic than cholesterol.

Low carbohydrate intake. Carbs are killing us. Don’t overeat.

Moderate exercise.

Stress reduction.

Update and revise our entire therapeutic protocols.

Look at diabetic risk using HgA1c as a glycation biomarker.

High dose fish oils.

Appropriate anti-oxidants.

Prevent heart attacks and strokes with my natural anti-coagulant routine.

Let me know what you think.

Philip Lee Miller, MD

Carmel , CA

December 7, 2018

2018-2019 Flu Vaccine, Prevention and Treatment

November 14, 2018 Philip Miller Comments 2 comments

This is my seasonal flu post. One that I update each year. Here are current recommendations and controversies regarding influenza vaccinations, prevention and treatment. I am going to give you a slightly expanded version this year related to last year’s flu vaccine post. In short, I have never been a proponent of flu vaccinations. I am middle of road on vaccinations. You really want polio, measles and mumps and tetanus every 10 years. For high risk exposures you want Hepatitis B vaccination. But we are over vaccinating our children and even pets.

Influenza is a seasonal epidemic viral syndrome that usually starts in December and lasts until approximately February or March. In the past, I would begin to see large number of acutely ill patients pouring into my Urgent Care clinics in October and November. I eventually termed this the “pre-flu” syndrome. Something approximating the flu but not the full-blown symptom complex. The true flu is manifest as fever, shaking chills, severe achiness (myalgias), and malaise. You feel really sick. This is more than a common cold.

Now the problem with flu vaccination recommendations is dependent on who makes the recommendation and for what population. I am going to make a recommendation for you specifically. This is in contradistinction to a public health official who epidemiologically makes decisions for large populations. They are concerned about “herd immunity.” Higher rates of immunized people decreases the spread. At least that is the theory.

There is no universal flu vaccine

The challenge has always been how to formulate this year’s flu vaccination. There is no universal flu vaccination. That is the basic dilemma. Influenza A is the more virulent strain mainly affecting adults. Influenza B affects mainly children. Influenza mutates by “antigenic drift” from year to year. It can even mutate during incubation. In most years, there is a “minor antigenic drift.” In some years there is a “major antigenic drift,” in which case far more people fall ill because they have not never been exposed to the current strain. And thus it is more virulent. A pandemic.

Flu Strains

Epidemiologists classify influenza with two attributes. H attribute (hemaglutinin). And N attribute (neuraminidase). H1N1 and H3N2 are targeted this year. So the recommended quadravalent (4 strains) flu vaccine being manufactured this year targets:

A/Michigan/H1N1

A/Singapore/H3N2

B/Colorado 2017 B/Victoria 87

B/Phuket 2013 B/Yamagata 88

Because we do not know the precise strain that will prevails this 2018-2019 season, it becomes our best educated guess. What is the most likely strain based on recent world wide observations. The selection process may begin in February of the current year. This gives enough lead time for sufficient vaccination stocks to be replenished each year. This takes time. It is all the guess. Again, the primary dilemma is – there is no universal flu vaccine. That is the holy grail. Research scientists are busy trying to develop this.

Vaccine Effectiveness Rates

CDC Seasonal Flu Vaccine effectiveness — Seasonal Influenza Vaccine Effectiveness, 2004-2018

Last year it was said that the flu vaccine was only 10% effective. In retrospect, the CDC published an average for all age groups of 40%. Here are the reported rates of effectiveness for the last 14 years [link is no longer available]. A more detailed breakdown by age for 2016-2017 shows even more variability. All these statistics are somewhat irrelevant. What is more relevant is the flu vaccination most often less than 40% effective. So the recommendation is based on, “well, it’s better than nothing.” I can’t think of hardly any other medication in use today were the rationale is, “well, it’s better than nothing.” Surely there must be a stronger argument and rationale to the widespread public campaign to “get your flu shot now.”

Recalling my days in Urgent Care once again in the early 1990s, it was common knowledge that “there is no medical treatment for the flu.” So you must get a flu vaccination. This always puzzled me because there was indeed a medication that treated the flu. Symmetrel (Amatidine). This was discovered by happen stance when so many Parkinson’s patients who were treated with Symmetrel for “the shakes” had a much lower incidence of the flu. I began using Symmetrel with rewarding success.

Anti-Virals now available

Today, we have a developing stable of anti-influenza virals. That is Tamiflu, Relenza, Rapivab and the newest Xofluza (Baloxavir). So you have a choice. You can have the flu vaccine in various forms. You can defer any vaccination and be treated with any of a number of antiviral drugs. Or there is a natural routine that I have developed over the years. Empirically quite effective.

My recommendation for a natural approach

Miller Anti-Viral Regimen ™

Vitamin D 50,000 daily x 5 days

Astragalus 1000 mg daily x 5 days

Thymic Protein A (TPA) 1-2 packets 3 times daily x 5 days

So what do I recommend? I have been a proponent of aggressive doses of vitamin D which is known to prevent seasonal flu syndromes. At the first sign of any viral illness or especially the flu, start taking vitamin D 50,000 units for 5 days. Yes that is high dose. Astragalus 1000 mg daily for 5 days and a proprietary product called Thymic Protein A (ProBoost). One packet 2-3 times daily for 5 days. This is a highly effective routine. And most effective when started in the first 48 hours. Sometimes this routine is so effective that after one or day, you may feel totally resolved and stop the routine. 2 to 3 days later, the virus is even stronger. So a 5 day routine is highly recommended.

Now let me know your thoughts and experiences.

Philip Lee Miller, MD
Carmel, CA 93923
Nov 2018

Vitamin D and Osteoporosis Prevention

October 8, 2018 Philip Miller Comments 1 comment

Vitamin D is back in the news again.

You may have seen recent news claiming vitamin D supplementation fails to prevent osteoporosis, fractures or falls. Published in the Lancet — a Systematic Review and Meta Analysis paper dated October 04, 2018 from the Department of Medicine, University of Auckland, New Zealand and the Health Services Research Unit, University of Aberdeen, Scotland, UK. They conclude and state at the end of a complex meta-analysis

“we believe there is no justification for more trials of vitamin D supplements with musculoskeletal outcomes because there is no longer equipoise about the effects of vitamin D on these outcomes.”

Rather strong conclusion designed to forestall any further investigation or discussion. Really?

Now personally, I owe my interest in vitamin D supplementation to my good friend Dr. William Grant of SunArc. And work that has been done by Dr. John Cannell, who founded the Vitamin D Council headquartered in Marina del Rey, California. Both are superb sources of ongoing vitamin D research.

A meta-analysis is a literature review of all relevant resource papers. It suffers from specificity and accuracy of database key words, capture and design. It is limited by various assumptions, and highly intricate statistical conventions. Studies are excluded or included based on assumptions of the authors.

One of my current criticisms of all these citations is failure of a popular news article to actually cite the source. So we cite here. Effects of Vitamin D supplementation on musculoskeletal health: a systematic review, meta-analysis and trial sequential analysis. You will have to pay to actually read this paper. So, I will summarize for you.

The paper is exhaustively written and detailed. But suffers from a number of limitations and dubious pharmacologic assumptions.

First, it is stated that there was no difference between high-dose vitamin D and low dose vitamin D. What defines high-dose and low dose? Low dose was <800 units per day. High-dose was >800 units per day. I always have issue with “greater than” or “less than” because of a lack of specificity. >800 could be 801, 1000, 5000 or 50,000. You don’t know. <800 could be 799, 700 or 100. To be somewhat facetious. But it is highly important because we don’t know from their study. What would be the ideal dose of vitamin D? Who decided on this magical 800 units number?

In fact, that is where 80% of all medical and scientific studies fail. Who chooses the ideal dose? On what basis is an ideal dose determined?

I often use a facetious example of Lipitor. Lipitor will lower your cholesterol. More specifically, your LDL values. I could design an experiment using 1 mg of Lipitor for one year. You will see no benefit. It is too low. A study using 1 mg would conclude Lipitor is a worthless drug. In the other hand, let’s use an arbitrary dose of 100 mg of Lipitor for a study. After one year I would conclude this is a highly toxic drug causing muscle pains, memory losses and liver abnormalities. A drug that is too dangerous. So at some point, scientists determined that the ideal dose of Lipitor is 10 to 40 mg. With a certain segment of the cardiology community is using extremely high doses of 80 mg.

Dose-response. A fundamental tenant of good pharmacologic design and use.

Now back to vitamin D. We are told that the levels achieved were were either >50 nmol/l or >75 nmol/l. Again we have the problem with the specificity of “greater than.”

Furthermore, most commercial clinical labs report in ng/ml not nanomoles/l. So >50 nmol/l = >20 ng/mL and >75 nmol/l = >30 ng/mL. What does this mean?

Vitamin D testing (using GC/MS/MS) is one of the lab tests that that is rationally graded on a continuum. Not simply high or low cutoffs. <15 ng/ml is (severely) deficient. 15 to 30 ng/ml is insufficient. 30 ng/ml to 100 ng/ml is sufficient. > 100 ng/ml is excess. And >150 is considered toxic. Never mind, that it is not toxic.

So that this meta-analysis using a “high value” of >75 nmol/ml ( >30 ng/mL ) is not high. It is barely therapeutic. Just barely at the very lower limits of therapeutic. Like driving a car with a 1/4 tank of gas.

Personally, and in the Anti-aging / Nutritional Medicine community a consensus seems to be a daily dose of 5000 units is the average starting dose for the overwhelming majority of our patients. Aiming for 60-80 ng/ml blood values. That seems to be the ideal dose and value. There are individual variations so that some of our patients will require 10,000 and 15,000 or as high as 20,000 units daily to achieve good therapeutic levels. In rare cases patients only need 3000 units. But clearly 800 units is nearly useless.

So this meta-analysis suffers from so many shortcomings. A meta-analysis is a poorly controlled study because it is a retrospective look at a host of studies all probably suffering from experimental design weakness. Then there is the highly intricate retrospective statistical conventions excluding and including various studies for capricious reasons. Starting with a completely capricious and arbitrary dose and level. And finally, we have no idea whether blood levels were drawn at one time during a study or weekly or monthly or the beginning or the end. Most likely levels were drawn very infrequently and then assumed to be constant through the study. Probably None of these studies were carried longer than one year.

Finally, Vitamin D alone is probably insufficient to enhance bone integrity and prevent osteoporosis. Empirically, I have observed osteoporosis is prevented by a combination of estrogen or testosterone vigor, vitamin D3, vitamin K2, the right balance of calcium and magnesium, and light weight bearing exercises. A study simply looking at the efficacy and levels in potency vitamin D will never prove the assertion that osteoporosis cannot be prevented by vitamin D.

There are some political considerations. The US Preventive Services Taskforce specifically recommended against Vitamin D supplementation to prevent fractures or falls. They intentionally excluded all of the known experts in vitamin D. Of which there are only 4 or 5 notable vitamin D researchers in the world.

So beware. This meta-analysis or study does not prove that vitamin D is either inadequate or useless. I personally recommend vitamin D at least 5000 units daily, Vitamin K2 15 mg, 800-1000 mg calcium 200-600 magnesium, weight-bearing exercises and evaluation of your hormonal status. This is simply a starting point. There is considerable variation from patient to patient. That is why you need expert advice and counsel. Reference my earlier blogs on Osteoporosis Prevention. And the importance of Vitamin K2.

Reader beware.

Philip Lee Miller, MD

Carmel CA