The Black Liszt

Summary: The Medical-Industrial Complex

Modern medicine can do wonderful things. I benefited from remission of an extremely rare form of cancer that was made possible by advances in the last couple of decades. At the same time, a great deal of what is done in medicine is controlled by the Medical-Industrial Complex, which causes untold waste and harm. These posts document the tip of that iceberg as my health journey has led me.

I've long had a concern that what doctors do often doesn't follow the clear evidence. For example, here's a case of blatantly ignoring standard practice with something simple.

https://www.blackliszt.com/2016/12/what-can-cats-teach-us-about-healthcare.html

No big deal. But then I encountered something far more serious. I tell the start of my story here, about heart symptoms caused by blood pressure pills.

https://www.blackliszt.com/2022/07/the-destructive-treatment-of-hypertension.html

The next part of my story is when I discovered there’s a large study demonstrating that taking blood pressure pills more than doubles your chances of getting AMD, which makes you blind.

https://www.blackliszt.com/2022/07/blood-pressure-pills-can-make-you-blind.html

It’s a study that none of the relevant doctors ever tells you about.

I backed up and studied hypertension. Expert opinion on the subject is united.

https://www.blackliszt.com/2022/05/the-experts-are-clear-control-your-blood-pressure.html

When you dig past the pronouncements of authorities, you discover that hypertension isn’t even a disease.

https://www.blackliszt.com/2022/06/the-facts-are-clear-hypertension-is-not-a-disease.html

So what happens when you stop taking the pills? At least in one anecdotal case, things change in good ways, and in any case, no harm.

https://www.blackliszt.com/2022/11/how-to-cure-amd-macular-degeneration.html

More digging led me to the bogus, incredibly destructive diet-heart hypothesis, proven false by the evidence but promoted on food packages and everywhere else.

https://www.blackliszt.com/2021/12/trusting-science-the-whole-milk-disaster.html

The idea is that eating red meat and full-fat dairy leads to heart disease.

https://www.blackliszt.com/2022/02/the-experts-are-clear-dont-eat-much-saturated-fat.html

When you dig past the propaganda, you learn that saturated fat is an essential and healthy part of your diet.

https://www.blackliszt.com/2022/03/the-facts-are-clear-eat-lots-of-saturated-fat.html

Eating saturated fat is supposed to increase your blood cholesterol, which leads to heart trouble, they say.

https://www.blackliszt.com/2022/02/the-experts-are-clear-keep-your-cholesterol-low.html

The widely-prescribed drugs that lower cholesterol don’t help with heart disease and cause problems of their own.

https://www.blackliszt.com/2022/04/the-facts-are-clear-dont-take-cholesterol-drugs.html

There is strong evidence that bad diet recommendations based on the bogus diet-heart hypothesis is a leading cause of the obesity epidemic that continues to worsen.

https://www.blackliszt.com/2022/04/the-forbidden-question-what-caused-the-obesity-epidemic.html

The current recommendations for diet and medical treatment of obesity continue the madness.

https://www.blackliszt.com/2022/09/the-medical-treatment-of-obesity.html

Exactly what ingredients are in the food you eat is crucial. Places that advertise that they're healthy can be tricky and require careful study of ingredients:

https://www.blackliszt.com/2021/06/ingredients-whole-foods-sneaks-in-sugar.html

The ingredients of things that aren't food should be read carefully:

https://www.blackliszt.com/2021/04/ingredients-and-truth.html

Many people receive reminders to get things like blood pressure and cholesterol checked so that drugs can be prescribed “if necessary.”

https://www.blackliszt.com/2023/02/be-healthy-and-dont-schedule-your-heart-health-visit.html

Disease Prevention and Testing

Disease prevention sounds like a great idea. So does early detection of bad things. When you dig into the evidence and the numbers, a different picture emerges.

Screening for colon cancer is a multi-billion dollar industry. The only large-scale study that’s ever been done shows that it doesn’t result in longer life.

https://www.blackliszt.com/2023/01/value-of-colon-cancer-screening.html

Everyone is supposed to get an annual flu shot. The CDC’s own numbers and massive studies show that you’re better off without it.

https://www.blackliszt.com/2022/12/flu-shots-propaganda-reality.html

Vaccine efficacy is often mentioned. Its technical meaning can be found, but the authorities rarely mention it. A large efficacy can still mean that you only have 1 chance in a hundred of being helped by the drug.

https://www.blackliszt.com/2022/09/does-vaccine-efficacy-of-95-mean-i-wont-get-sick.html

Your chances of being helped (NNT, Number Needed to Treat) must be considered along with the chances of being harmed, a thing that is too-often ignored.

https://www.blackliszt.com/2022/09/nnt-for-benefits-and-for-harms.html

The studies that are supposed to show treatment effectiveness are too often biased, and (shockingly) backed by data that is kept secret by law. If the treatment is wonderful, why keep the data secret?

https://www.blackliszt.com/2022/11/revolutionize-health-by-making-medical-data-and-studies-open-source.html

There is a proven path to make drug discovery and testing a quantum leap better. All the authorities and experts ignore it.

https://www.blackliszt.com/2017/01/using-software-methods-to-speed-drug-discovery.html

Given the results, the common-sense idea of wellness visits stops making sense in most cases.

https://www.blackliszt.com/2023/02/be-healthy-and-schedule-your-annual-wellness-visit.html

Of course there is a great deal more to be said on this subject. There are true experts, far more qualified than I am, some of whom are referenced in the above posts. My intention is these posts was to detail the journey that a normal patient took from trusting and naive to the opposite. Again, there are wonderful benefits for patients from doctors and hospitals; but not everything that is recommended is wise to take/do.

The Value of Colon Cancer Screening

The health experts are united in proclaiming the importance of preventative health in general, and regular colonoscopies in particular. Get one so you can avoid dying of colon cancer! As is sadly all-too-usual, the colon cancer early detection campaign is propaganda to cajole people into putting lots of money into the pockets of doctors and health systems -- with no provable benefit to the patients who do their best to patiently put up with the pointless nonsense.

Do people who get colonoscopies avoid getting colon cancer? Yes, the vast majority of tested people avoid it; but then the vast majority of untested people also avoid getting it. Does getting colonoscopies as recommended help you live longer? All the authorities say it does, but the recently published RCT (random controlled trial) with over 80,000 subjects -- the ONLY such gold-standard trial EVER conducted -- shows that colonoscopies do NOT help the people who get them live longer.

It's no wonder that the medical-industrial complex has united to discredit this trial that threatens their revenue stream. Experts are speaking out, waving their arms wildly and pronouncing with deep-voiced authority that the trial is misleading. I guess all the people and organizations drinking from the fire hose of tens of billions of dollars a year in testing fees have been too busy to conduct a trial of their own to demonstrate that what they do actually helps people.

Colon cancer is a big deal

There is no doubt that colon cancer is something to be avoided, if at all possible. It's the fourth leading cause of cancer deaths, behind breast, prostate and lung cancer. Lots of people are diagnosed with it and die from it, according to the National Cancer Institute:

Getting colon cancer isn't a death sentence -- look at the survival rate above -- but we would all like to avoid getting it.

An ever-increasing number of people are screened for this terrible disease. According to the National Cancer Institute:

This adds up to over 16 million colonoscopies in 2019! The cost? Good numbers are hard to find, but it's probably in the range of $30 to $60 Billion dollars a year for screening.

The Voice of the Experts

Here is the summary recommendation of the U.S. Preventative Services Task Force:

The Grade A is primarily because the screening has "substantial net benefit." (Bold in the original.)

This organization has plenty of prestigious company in making this recommendation. For example, they say:

There is a general consensus that average-risk adults aged 50 to 75 years should be screened. The American Academy of Family Physicians (AAFP),⁴² American College of Physicians (ACP),⁴³ American Cancer Society (ACS),⁴⁴ and the US Multi-Society Task Force (which includes the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy)³¹ all recommend routine colorectal cancer screening in this age group, although specific recommended tests and frequency of screening may vary.

It's not just the big organizations. Doctors and health systems on the front lines pitch the same message. Mount Sinai hospital in New York City recently put up a strong pitch on the subject. They lead their long article with this:

Colonoscopy is one of those important, routine medical procedures that most people would rather avoid. But experts say the test is a highly effective tool for both preventing colorectal cancer and diagnosing it at an early stage.

Along with the American Cancer Society, they recommend that screening start at age 45.

The trouble is, when you read all this carefully, particularly the extensive review that led to the USPST report above, you find a complete lack of RCT's for the effectiveness of colonoscopies. Nothing but modeling and authoritative-sounding guessing.

Experts attack the skeptics

Every once in a while, someone pops up who says that colonoscopies don't do any good. Fortunately for concerned patients, the experts tend to jump on such baseless assertions and tear them apart with facts and sound reasoning. Most of the Mount Sinai article just mentioned is devoted to this. It says:

Those looking for an excuse to put off a colonoscopy might now point to a large study conducted in Europe and published in September 2022 in The New England Journal of Medicine (NEJM) that appeared to question the benefits of colonoscopies.

For some reason, the Mt Sinai article fails to give a link to the study in question, which is here. I guess they feel that readers don't need to waste their time, since Dr. Greenwald's  take-down is authoritative. It continues with this:

In this Q&A, Dr. Greenwald, Immediate Past-President of the American College of Gastroenterology, and Co-Chair of New York’s Citywide Colorectal Cancer Control Coalition (C5), discusses the recent study and why the value of colonoscopies remains unchanged.

Here's the man himself. He is a seriously authoritative-looking guy:

The NordiCC Study and the response of the Experts

The NordiCC study is the one described in the recent New England Journal of Medicine article that Dr. Greenwald tore apart in the Mt. Sinai article promoting colonoscopies. The study followed over 84,000 "presumptively healthy men and women 55 to 64 years of age drawn from population registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014."

The article seems to support performing colonoscopies. Here's the conclusion of the Abstract at the beginning of the paper:

In this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy than among those who were assigned to no screening.

I guess Dr. Greenwald and others were concerned about the fact that the numbers weren't strong. The Mt. Sinai article said the study "appeared to question the value of colonoscopies." Dr. Greenwald is quoted by Mt Sinai as saying

This study, along with prior studies, shows that colonoscopy decreases your chances of getting and dying from colorectal cancer. Getting sick and dying from colorectal cancer—especially due to delayed screening—is real. Screening with colonoscopy saves lives.

Done!

The NordiCC Study

Why would multiple European national governments go the trouble and expense of such a massive trial if the value of colonoscopies had been conclusively proven? Hmmm. The answer is simple: colonoscopies are expensive and highly unpleasant, and there have been NO RCT's that show a causal relationship between getting them and avoiding getting and dying from colon cancer. So before taking on all the cost and trouble, those groups figured they'd better get some real evidence on the subject.

First, let's see what the expert from Mt Sinai drew from the study:

Most importantly, in the section of the study that analyzed people who actually had a colonoscopy, the risk of developing colorectal cancer decreased by 31 percent and the risk of dying from colorectal cancer decreased by 50 percent, which is huge.

Wow. Why would anyone be worried about the NordiCC study scaring people from getting a colonoscopy, when it has such a huge benefit -- and the doctor claims that in the US it is performed better, yielding even stronger preventative results!

When you read the NordiCC study itself, aided by understanding of the statistical tricks that are used to distort the results, a whole different message emerges. This is why the medical-industrial complex goes to great lengths to hide the truth.

In this case, the core trickery is a biased sub-group created from the group invited  to have a colonoscopy that they call an "adjusted per-protocol analysis." The other main tricks are widely used: reporting "efficacy" (relative risk); ignoring NNT (absolute risk); and endpoint selection (dying of cancer vs. dying of any cause).

Here is a brief summary of the real results of the trial by Dr's John Mandrola and Vinay Prasad. I have verified that this summary accurately reflects data in the NEJM paper (see Table 2 of the paper):

• Over 10 years of follow-up, an invitation to screening colonoscopy modestly reduced the risk of being diagnosed with colorectal cancer, but it did not significantly reduce the risk of dying from colorectal cancer. Survival from cancer was nearly identical in both groups.  And all-cause mortality was the same.

The specific numbers of the primary outcome:

• The chance of getting (diagnosed with) colorectal cancer in the invited group was 0.98% vs 1.2% in the usual care group. This represents an 18% reduction in relative terms, and an absolute risk reduction of 0.22% or 22 per 10,000.

• The chance of dying from colorectal cancer in the invited group was 0.28% vs 0.31% in the usual care group. This 10% reduction in relative terms amounted to a difference in 3 in 10,000 and did not reach statistical significance.

• In the invited group, 11.03% of patients died; in the usual care group, 11.04% of patients died.

Here is a key chart from the paper, showing the risk of dying from colon cancer. Note that the real data is a barely noticeable squiggle along the X axis at the bottom; most of the chart is a big blow-up of the bottom 1% of the Y axis.

The tiny difference (3 in 10,000) in dying of colon cancer was not statistically significant. And the most-important-of-all measure, all-cause death, was identical.

Those are the indisputable facts from the study itself.

The authors of the study did their best to fiddle with the results -- they declared themselves to be "disappointed" in the study results. They put their fiddling in the paper.

The most significant game they played involved the fact that 42% of the subjects who were invited to have a colonoscopy actually had one. They recalculated the results for just the people in the invited group who actually had the procedure, trying to get better results; in the study, they call this a "per-protocol analysis." This shows the desperation of the authors, since doing this violates all the randomness and invites a host of what statisticians call "confounding factors," exactly the thing that a RCT avoids by being random. Naturally, this improved the results. By a small amount.

The authors and all the establishment defenders of colonoscopies do the classic thing that people who want to promote a drug or procedure do to mislead patients: they focus on relative risk instead of absolute risk. Relative risk, often called "efficacy," makes you think that the procedure is terrifically effective. What do you think when you read that your risk of death is "decreased by 50 percent?" It's huge, right? See this post on vaccine efficacy for a detailed explanation. What most people care about is absolute risk, which is how likely it is that the feared thing will happen to you. This is sometimes called NNT (Number Needed to Treat), which is the number of people who have to undergo the procedure in order for just one of them to benefit.

The per-protocol analysis (the best case) showed the risk of dying from colon cancer to be 0.15% in the invited group and 0.30% in the control group. This is a 50% improvement in relative terms which sounds great!  But in real-life absolute terms, it's a different of 0.15%, which is 15 for each 10,000 people And again, the difference of dying from any cause between these two groups was effectively zero. Here is a detailed discussion of per-protocol fiddling and the results of a statistically sound approach, which reduces the statistical significance of the colonoscopy benefit to zero ... as shown in a table of the supplement of the NEJM study.

And then there are the harms. What can go wrong with a colonoscopy? The USPST, the government group quoted above that recently recommended that colonoscopies start earlier than before, at age 45, discusses them deep in the supporting material. They report: "Harms from screening colonoscopy have been reported in 67 observational studies (n = 27,746,669)." You have to read carefully, Here's what they report:

14.6 major bleeding events per 10,000 colonoscopies (95% CI, 9.4-19.9; 20 studies; n = 5,172,508) and 3.1 perforations per 10,000 colonoscopies (95% CI, 2.3-4.0; 26 studies; n = 5,272,600)

That is a high confidence result of harm based on millions of patients, vs. the nearly identical low-confidence results of benefit from the NordiCC study.

Conclusion

The authors of the NordiCC study wanted to find that colonoscopies are effective -- they say so! They did their best to slant the results and obscure the real results. Experts reporting on the study in the US cherry pick and criticize the slanted results and confidently proclaim that colonoscopies are essential to health and longevity, when the clear numbers in the published study of over 80,000 subjects show no such thing. This is yet another example of self-serving advice from a medical establishment that depends on trusting, gullible patients to keep the money rolling in. For more, read these posts about flu, diet, saturated fat, cholesterol and blood pressure.

Why do insurance companies jack up premiums to shell out big bucks for drugs and procedures that don't help?

 

Flu Shots Propaganda and Reality

The drumbeat happens every year, echoing far and wide: It's flu season! Protect yourself and others -- get a flu shot right away! Roughly half of the population heeds the message and gets the shot.

The reality of the flu and flu vaccines can be found, but it's elusive. Once you find out what's really going on, you can't help but wonder why public authorities and provider groups keep pounding everyone to take these shots.

What we're told about the flu and flu shots

I got an email from my primary care provider. Here was the attention-grabber:

And here was the lead paragraph:

They go on to give lots of detail in an FAQ.

It's pretty clear: get a flu shot and you won't get the flu. It's not just my medical group; they all seem to say it, along with major pharmacies like CVS. The FDA is equally clear: "A flu vaccine can be given to anyone who wants to avoid the flu (persons over 6 months of age."  The CDC pushes it hard:

The message is similar to "shovel the snow off your snowy walk, and you won't slip and fall." 

The flu is awful!

The CDC makes repeated strong claims about how awful flu is and how flu shots protect you from getting the flu. Surely those claims are backed by solid data, gathered by some of the more than 10,000 employees of that organization.

First, the CDC collects and presents highly detailed data about what they call the "burden" of flu, by which they mean the number of people made ill, hospitalized or killed by it. While the numbers vary from year to year, the totals are massive:

For example, for the last flu season entirely unaffected by Covid, here are the annual numbers from the CDC:

The overall burden of influenza (flu) for the 2018-2019 season was an estimated 29 million flu illnesses, 13 million flu-related medical visits, 380,000 flu-related hospitalizations, and 28,000 flu deaths (Table 1)

Huge, right? It makes sense that everyone should be protected against these consequences of the terrible disease of flu.

Let's dig a little deeper into those catastrophically bad outcomes. Again, we'll use the CDC's own data.

First, let's look at the flu disease burden by age. The CDC, quite sensibly, presents these next numbers as a rate per 100,000, so that you can get how likely the outcome is to actually affect you.

For little kids, age 4 and under, the rate of catching the flu is a whopping 15,238 per 100,000 -- about 15% of little kids got the flu! For people aged 5 to 64, it was in the range 7- 12,000 for most older kids and adults; less for those 65 and older. Lots of people get the flu, around 10%.

With so many people catching the flu, it makes sense that the flu shot is pushed by health authorities. It's not rare, it's widespread! The numbers back it up.

What about all those hospitalizations and deaths?

While getting the flu, going to the doctor and even getting hospitalized aren't great, the thing you really want to avoid is death.

So what happens after you get the flu? For the vast, vast majority, not much. For young kids and older adults, only 0.1% end up in the hospital, and for most it's less than half of that. Death? The death rate for adults 18 to 49 is 1.2 per 100,000. That's a rate of 0.001%. The rate for younger people is even lower.

How the the flu rank among the other causes of death? The CDC has the numbers.

Flu ranks number nine out of the top ten, about the same as kidney disease. Things like accidents, strokes and the ever-present heart disease and cancer are way more dangerous. And the chart says "flu and pneumonia," without getting specific. Chances are it's mostly pneumonia. From another CDC data table, I find that the rate of death due to suicide in 2019 was 14.5 per 100,000. So the chances of dying from the flu or pneumonia were about the same as killing yourself!

But wait! Something's wrong! The deaths per 100,000 are listed as about 13, while we learned from the CDC (table 2 above) that the flu deaths for kids and adults per 100,000 were only about 1 -- truly tiny!

Putting the death rate for kids and most adults into the chart above, the rate of dying of the flu is less than one tenth that of the least likely of the top ten, way under 1% of dying from one of the top two causes. For kids and most adults, dying of the flu is not even close to being a leading cause of death.

Old people and the flu

Let's read the stats about flu burden by age (table 2 above) more carefully. Go down to the bottom and look at the numbers for older people, 65 and over. Only 4% of older people get the flu (way less than other ages), but for those who do, the rates of hospitalization and death are dramatically higher. Roughly 10% of those who get the flu end up in the hospital and 10% of the hospitalizations result in death! That's a mortality rate of 40 per 100,000. So it's the old people dying of flu (and pneumonia) that puts flu into the top ten causes of death! Without the old people, not only would the flu death rate not make the top ten causes of death, it would be less than 10% of the bottom cause, kidney disease! And way lower than other things such as accidents and suicide.

Let's understand the death rate for old people. Yes, it's forty times larger than the rate for most younger people. Scary, right? But running out the numbers, 0.4% of old people are hospitalized due to flu, and 0.04% of old people die of the flu. That's according to the CDC. Here's a chart from the CDC's annual report (a PDF file) of the leading causes of death for older people:

See flu and pneumonia there on the left? Pretty low on the list of things for older people to be worried about.

The charts for younger people are also interesting. For ages 10 to 24, accidents, suicide and homicide cause more than two thirds of deaths, while flu is less than a percent. For adults aged 25 to 44, flu is one percent, while for ages 45 to 64, flu doesn't even make the chart.

What about the flu shots?

The CDC and the rest of the health establishment may flash warning lights with loud warning sounds about the flu and how we need protection from it, but we now know that the numbers aren't compelling. But getting a flu shot isn't a big deal. shouldn't we get it anyway so that we're protected against the flu?

Flu shots: the CDC

First, let's look at the CDC's own numbers. They went to the trouble of assembling patient panels so they could get good numbers. The numbers have increased over the years; the recent 2018-19 panels are over 10,000 people. Here is the chart from the 2018-19 panel for effectiveness of flu shot against by age:

This is tough to make sense of at a glance. First, look at the top line, for all ages. 2763 people got the flu -- and almost half of them (48%) were vaxed! Meanwhile, 7249 people were flu-free, with a bit over half (56%) vaxed. Clearly, the vax didn't make much difference.

The numbers for older people are interesting. As we saw above, people 65 and older are the least likely to get the flu but the most likely to be hospitalized or die from it. The table shows that the older were far more likely than the rest to be vaxed, over 80%. But the number vaxed was nearly identical in the groups with and without the flu. Let's dig in.

The last column, CI (confidence interval) will be mysterious to most people. The CDC has an explanation in its section on vaccine effectiveness  It's standard statistics. They give the effectiveness number based on a tiny fraction of the number of people who could get the flu. How likely is it to be the true value? The CI is the range of values it would be, with 95% statistical confidence. See the negative numbers in the far right for teens and adults age 50 and older? According to the CDC (and statistics in general) that means:

...if a confidence interval crosses zero, for example, (-20% to 60%), then the point value estimate of VE provided is considered “not statistically significant.”

Not only was the VE tiny, the number is effectively meaningless -- the flu vax could increase your chances of getting it, or decrease your chances. The CDC's main flu vax effectiveness ongoing study can't tell the difference! Which means ... getting the flu shot has no impact on whether you get the flu.

Flu shots: published controlled trials

There have been dozens of published controlled trials of flu vaccines in multiple countries. Reviews of the many trials have been conducted and published. This is an updated version published in 2018 of the prior review.

We included 52 clinical trials of over 80,000 people assessing the safety and effectiveness of influenza vaccines.

The effectiveness they found:

Inactivated influenza vaccines probably reduce influenza in healthy adults from 2.3% without vacination to 0.9% (risk ratio (RR) 0.41

"Risk ratio" is what is called the "efficacy" of the vaccine, normally reported as a percent; in this case it would be 41%. Most people when they read a number like that think it means they've reduced their chances of getting the flu by about 40%. Not so. Read the quote again: "2.3% of the unvaccinated got the flu, while 0.9% did get it." This means that most people didn't get the flu, whether vaxed or not. The study translates this into NNV (number to treat NNT, which is NNV for vaccines -- see this for an explanation)

71 healthy adults need to be vaccinated to prevent one of them experiencing influenza,

What about other consequences?

Vaccination may lead to a small reduction in the risk of hospitalization in healthy adults, from 14.7% to 14.1%

What do they conclude?

Healthy adults who receive inactivated parenteral influenza vaccine rather than no vaccine probably experience less influenza, from just over 2% to just under 1% (moderate-certainty evidence). They also probably experience less ILI following vaccination, but the degree of benefit when expressed in absolute terms varied across different settings. Variation in protection against ILI may be due in part to inconsistent symptom classification. Certainty of evidence for the small reductions in hospitalizations and time off work is low. Protection against influenza and ILI in mothers and newborns was smaller than the effects seen in other populations considered in this review. Vaccines increase the risk of a number of adverse events, including a small increase in fever, but rates of nausea and vomiting are uncertain. The protective effect of vaccination in pregnant women and newborns is also very modest. We did not find any evidence of an association between influenza vaccination and serious adverse events in the comparative studies considered in this review. 

Makes you want to run right out and get the shot, doesn't it?

Flu shots: Huge UK study on older people

There was a massive study in the UK on the extent to which getting flu shots helps older people. This is the background they give:

Observational studies using traditional research designs suggest that influenza vaccination reduces hospitalizations and mortality among elderly persons. Accordingly, health authorities in some countries prioritize vaccination of this population. Nevertheless, questions remain about this policy's effectiveness given the potential for bias and confounding in observational data.

They studied adults aged 55 to 75 in England and Wales during 2000 to 2014. Here is what they found:

The data included 170 million episodes of care and 7.6 million deaths. Turning 65 was associated with a statistically and clinically significant increase in rate of seasonal influenza vaccination. However, no evidence indicated that vaccination reduced hospitalizations or mortality among elderly persons. The estimates were precise enough to rule out results from many previous studies.

Flu shots: are they harmless?

The data says clearly that flu shots don't do much good. But it's no big deal to get one, it might help, so why not? It turns out there are good reasons to avoid getting the flu vaccine, based on how vaccines work and supported by data. The CDC even explains some it, buried away.

Let's start with a little-discussed fact: vaccines do not in themselves prevent anything. Everyone has an immune system. Immune systems are amazing things. They fight against a huge variety of invaders to the body, defeating the vast majority of them most of the time. What vaccines do is "trick" the immune system into strengthening its defenses against a particular invader by sending things that look like the real attackers, except they've been neutered. Here's the issue: immune systems don't have endless defensive "weapons," so increasing defenses against one thing means decreasing them for others. Also the defenders aren't endlessly energetic. If they've been mobilized against an attack that doesn't occur, they don't have as much energy for the next mobilization.

This means that if you trick the immune system into shifting weapons for a threat and a different one occurs, the defense against the real attackers isn't as strong. This happens every year with flu vaccines as the variants change and particularly older peoples' immune strength fades. It also happens with covid.

Here is a summary of the most important studies.

The CDC has claimed that influenza vaccines do confer this benefit to older people. However, to support that claim, the CDC relies on observational studies that have been discredited by the scientific community.

In fact, as observed in a 2005 study in Archives of Internal Medicine (which is now JAMA Internal Medicine), despite a considerable increase in vaccination coverage among the elderly between 1980 and 2001, pneumonia and influenza mortality rates actually rose substantially. A 2008 review in Virology Journal similarly observed that “influenza mortality and hospitalization rates for older Americans significantly increased in the 80’s and 90’s, during the same time that influenza vaccination rates for elderly Americans dramatically increased.”

The effect of influenza vaccines on influenza mortality—much less their effect on all-cause mortality—was never studied in clinical trials, and later studies showed that the studies relied upon by the CDC to support its claim were fatally flawed due to a selection bias known as “healthy user bias”. In short, it wasn’t that elderly people who got a flu shot were less likely to die that flu season but that elderly people who were so frail that they were likely to soon die were less likely to get a flu shot. As a 2006 article in the International Journal of Epidemiology observed, the magnitude of this demonstrated selection bias “was sufficient to account entirely for the associations observed”.

In other words, there is no good evidence to support the claim of a mortality benefit of influenza vaccination for elderly people.

Unlike some vaccines, flu vaccines don't seem to do much active harm to those who get them. However, they do little to no good, and getting them repeatedly weakens your immune system, making you more likely to get the disease you are supposedly protected from. The fact that as more elderly people get the flu shot the more of them die of the flu is unsettling, to say the least. Doesn't sound like a boat I'd like to jump on to.

Conclusion

Why does the entire health establishment keep banging away at promoting flu shots? What is it exactly that causes the medical establishment to heavily promote treatments that not only don't help but can seriously hurt you? Things like diet, cholesterol, blood pressure and flu? If your goal is to promote trust in government and medical health advice, this is the last thing you should be doing.

Revolutionize health by making medical data and studies open source

Medical studies are essential to knowing what works and what doesn't work in medicine. There are a few problems, though. There aren't nearly enough studies, they are expensive and cumbersome, the funding is often by groups seeking an outcome, there isn't enough follow-up, most of the data is secret and they are rarely crafted for personalization. Among other things. What can we do?

Often the cure for a problem isn't isolated genius, but finding a field that had a similar problem that got solved and adapting the solution. I propose that the problem of building software (expensive, cumbersome, takes too long, etc.) is similar to that of medical studies, and the solution of making software open source can be adapted to the problem of medical studies. If medical research and data were open source, most of the problems I listed could be solved.

Open Source Software

The open source software movement has revolutionized the industry. Operating system software, for example, was the proprietary crown jewel of computer manufacturers. IBM's 360 mainframe operating system software, for example, took over 1,000 people years to build. A well-known book by one of its leaders, Fred Brooks' "The Mythical Man-Month" went into detail explaining the nightmare.

There's been a revolution since then. The Linux operating system completely dominates the operating system market; for example, it runs on over 95% of the top million web servers. This isn't new news -- Linux was started over 30 years ago! Since then, even major profit-making software companies such as Google (Android, Chrome, Kubernetes) and Facebook (React) sometimes open-source valuable software they've built internally.

Much (not all) open source software is built by volunteers and the resulting software is freely available. Sometimes company employees work on open source that is valuable to their employers. There are hybrid models such as Red Hat, which charge for services they offer to companies that want to use the open source software. After the early years of resistance and skepticism by traditional programmers and managers, open source software is broadly accepted as a fact of life -- and a good fact! -- in the software world.

Open Source Medical Data

The data from a research study is incredibly important to the people whose disease or condition is studied, to the medical professionals who treat it and to the device or pharma company that creates the new device or drug. The results of the study cause the patients (guided by medical providers) to take drugs, change their behavior or undergo procedures that can have a major impact on their lives. Shouldn't that data be freely available to anyone who cares to study it? Just as open source software hugely benefits by having large numbers of volunteers pore over the code looking for errors, limitations and omissions, so would open source medical test data benefit by having large numbers of people who are even more motivated than software contributors comb through the data -- in software, we're talking about annoying bugs, while in medical data we're talking about life and death.

Anyone with software experience knows that no amount of software testing in a lab environment can match what happens to the software when it's widely distributed. When things go wrong with open source software in the field, open source contributors have a real-life test case of error and have a reasonable shot of finding and fixing the problem, contributing their fix to the central source code. With thousands upon thousands of copies of the software working all over the world and motivated engineers responding to issues and pooling their solutions, open source software achieves a quality that can't be matched by dedicated groups of employees working for a company. Much less a government agency.

The equivalent of this for medical testing is to start with opening all the test data to volunteer analyzers, withholding nothing. Releasing all the data that is now kept secret would be a big step forward.

But that's the equivalent of lab testing.The huge value in open source data will come from extending it to more people than were included in the study, and to include much more data about them, both before the formal start of the study to continuous aggregation of data over time. Among other things, this will enable surfacing factors that weren't considered by the original study designers, both from patient history and from medical events that take place after the formal end of the study. For example, this kind of extended data could surface the facts about the relationship between blood pressure pills and going blind, as I describe here and here.

Open Source Medical Studies

There is no reason why paid medical researchers couldn't continue to define and run medical studies in much the same way as they do today, much the same way as for-profit tech companies create software that they then open source. However, they would have to make 100% of their data open source and fully available anyone to investigate.

The "open source" version would be first to expand the selected participants in the study far beyond what would normally be done with volunteers, and second to extend the data collected to everything that is knowable about the participants, both before the start of the study and continuing long after what would normally be its conclusion. I don't claim to know how best to accomplish this, but I know that today the cost of running study sites, qualifying participants and so on is high. A way would have to be found to enable participants to volunteer remotely, and to enable local volunteers to perform whatever actions like drug injection that have to be performed locally and physically.

This process really kicks in when the new drug or procedure gets past the test environment and becomes more widely deployed. It would be good to emulate the open source software practice of having a careful staged roll-out of a new release instead of the current medical practice of unlimited distribution after approval. This would enable reports from the field, enhancing the open source data, to surface problems that weren't clear in the earlier, more limited testing of the new drug or procedure.

Once the distribution gets very broad, there still needs to be a way to surface and report issues. For example, here is a message from Google to enable broad data reporting about one of their products:

Why shouldn't such permission be added to patient medical records, so that as those records are updated for any reason, the updates are added to any relevant open source data collections? This would make longitudinal tracking automatic and painless to everyone involved.

Conclusion

Medical studies and associated data strongly resemble the proprietary operating systems of computer vendors in the 1960's and 70's. Each body of code was created at great expense by employees of the companies. The code (like medical data) was considered a trade secret, never to be revealed to an outsider. Problems usually surfaced after the code was shipped, just as many problems with approved drugs only surface after they are distributed. Manufacturers kept spending more time and money to make their software bug-free in the lab before shipment, but never got it right -- just as drug makers jump through endless FDA hoops prior to approval, and there are still problems. Makers of proprietary software have huge quality problems to this day, as I have documented, which the "free" open source software largely avoids.

Applying open source software concepts to medical drug and procedure testing and tracking could greatly enhance the safety and effectiveness of augmenting the toolkit available to patients who have medical issues. As it became understood and widely used, patients would have reason to have confidence and trust in the medical profession far beyond what many of them have today. Instead of being constantly hammered about how some drug is "safe and effective," which kinda tells many patients that it probably isn't, the open source method would create a level of transparency and openness that would let people draw their own conclusions.

I have been thinking of this issue for a long time; a discussion with Jonathan Bush at the recent HLTH conference inspired me to write it up.

 

NNT for Benefits and for Harms

In a previous post, I described the difference between relative risk (efficacy), absolute risk and the related concept of NNT (number needed to treat). In that post I focused on the NNT to get the benefit of the treatment. In this post I will focus on the essential other half of NNT: the NNT to be harmed.

I will mostly focus on the direct harms of the treatment itself. However, in some cases, there are harms that come from other actions taken to treat or avoid a medical problem. Sometimes the harms can be large. The study of these indirect harms is not as advanced in the scientific literature as the direct harms, but given how large the scale of the indirect harms can be, they should be made standard. practice.

NNT for Harms

NNT is a simple way to understand how probable a given outcome is likely to be in absolute terms.

Sometimes there aren't any harms, as in this meta-analysis of over 240,000 patients in 18 studies.

What's important to note is that the researchers looked not only for the benefit of fever reduction, but also for the harms that had been suspected for one of the treatments.

Here is one where the NNT for harms is crucially important -- because the treatment that is supposed to prevent heart attacks caused more of them than it prevented!

The case above illustrates an important aspect of NNT: it should cover (if appropriate) multiple possible benefits and multiple types of harms.

Just because NNT harms outweigh benefits for a treatment doesn't mean that medical practice responds appropriately. For a long time, high blood cholesterol was thought to cause heart attacks. Statins became widely prescribed to lower the number. But now it is scientifically proven that blood cholesterol should not be lowered and therefore statins should not be taken. In spite of the fact that NNT harms are strong with no benefits, it remains standard practice for doctors to prescribe statins to lower the cholesterol level to meet now-disproven standards..

Sadly, this raises the issue of conflicts of interest and transparency in scientific research, and the readiness of the medical profession to update practices when the science demonstrates that it should. It's even trickier when a pharmaceutical company conducts studies to prove that a drug it developed has important benefits and minimal harms.

NNT Harms for covid vaccination

The FDA's EUA (Emergency Use Authorization) Issued in December 2020 for Pfizer's covid drug claimed 95% effectiveness, and listed minor side effects which lasted just a couple days. The FDA gave full approval for the drug in August 2021.

The full approval document stated that "the vaccine was 91% effective in preventing COVID-19 disease." No explanation was given for the reduced effectiveness. Unlilke the EUA document, the absolute numbers of infections were not disclosed, therefore giving a highly misleading impression of how likely any person who got the vaccine would be helped by it, implying that 90% of the vaxed would be protected vs. the actual number of under 1%.

For harms, most of the minor harms of the EUA were repeated. However, they disclosed that myocarditis and pericarditis were suffered by young males: "Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes." Sadly, they provided no data, no NNT for Harm.

I have yet to find good numbers for NNT Harms for covid. This should be easy, but as it turns out, the vast majority of the relevant data is secret. Yes, secret by approval of the FDA.

However, I've dug into a couple of issues based 100% on published scientific data. For example, I found a paper published in April 2021 in the New England Journal of Medicine on Vaccine Safety in Pregnant Persons. The paper showed that the mRNA vaccines were safe for pregnant people to receive. Here is Table 4 from the original paper, showing that there were 104 spontaneous abortions out of 827 vaccine recipients, about 12%, which is within a normal range.

Here is the footnote to the last column, about the numbers of people involved.:

A correction was published in October 2021 in the same journal, after the FDA's full approval had been issued. A casual reading of the correction, including the summary and abstract, makes it seem as though nothing significant was changed.

Here is Table 4 in the corrected paper:

The number of spontaneous abortions remained at 104, but the totals and percentages were dropped. The explanation is found in the footnote:

The footnote leaves the impression that nothing can be concluded. However, returning to the footnote in the original paper, we read "...based on 827 participants ... who received a Covid-19 vaccine ... A total of 700 participants (84.6%) received their first eligible dose in the third trimester..." So 700 participants could not have had spontaneous abortions, since all those took place in the first 20 weeks of pregnancy.

The arithmetic leads us to 827-700=127 participants were vaccinated earlier, and 104 of those participants had spontaneous abortions. The vast majority. This is clearly something that the authors should have pointed out and explained. Maybe my logic here is wrong.

This leads us to wondering what should happen:

What should happen

First of all, the authors should have made clear the implications of their correction. If indeed the data shows that spontaneous abortions were excessive, they should have said so, and promised further study to confirm.

Second, data about medical treatments of all kinds, including drugs, should be fully open source, the way some software is. That way, others could do the job that the authors of the study failed to do. The developer of the drug should open its data to the public, just like the source code to software like Linux is 100% open for copying, testing and use. This by itself will solve many problems. It will also enable problems to be surfaced quickly, so that a minimum of people are hurt by the problems. If drug makers were truly interested in safety and effectiveness, they would welcome the additional scrutiny.

Conclusion

NNT is an essential measure for treatment effectiveness. Every time a treatment is proposed to a patient, NNT should be part of the discussion. Certainly NNT for benefits is important -- that's the whole point of the treatment. But NNT for harms is regularly left out of the discussion. Instead, it should be brought to the forefront.

Does Vaccine Efficacy of 95% mean I won't get sick?

The Moderna and Pfizer Covid vaccines have 90-95% efficacy, but the studies submitted for their approval showed they helped only about 1% of the people who took them. This is news to most people. How can this be?

We are constantly told that vaccines are safe and highly effective, for example by the CDC. Numbers like 90% efficacy are thrown around, which most people understand to mean that getting vaccinated means there's only a 1 chance in 10 that you'll get sick. You're really protected!

What the CDC and major authorities fail to disclose is that standard statistical methods applied to the vax vendors' own data shows that only about one in a hundred people who get the jab would be protected from getting covid! The tests did indeed show 90% or better "efficacy" (relative risk improvement), but what's more relevant is "absolute risk" (AR), which their own data showed was around 1%.

Read on to understand these industry-standard measures that are mostly ignored; if widely understood and acted on, they would transform not just vaccines, but pharma and public health in general.

Winter Coats and Vaccines

Winter coats are a standard solution to protect people from getting cold when the weather outside is cold. Kind of like when the air is suffused with invisible vaccine particles, you want to help your body defend itself.

There are a wide variety of coats available to protect against the cold. What would happen to a new coat vendor that promoted its coats as being highly effective against the cold, protecting most people who wear them, but it turned out that the maker and seller knew that 99% of the people who wear them on a cold winter day wouldn't be helped by them -- word would get out quickly and the coat maker's reputation would be in the cellar.

What would happen if major authorities had subsidized the coat making, regulated their testing, and then promoted them as "safe and effective?" And then what would happen if all the authorities demanded that you buy and wear the coats, to the point refusing to let you enter a football stadium on a cold day unless you were wearing one of the approved coats? There would be mass revolt. Which is what would have happened with covid if people knew the facts that were so carefully concealed from them.

When locations like restaurants and performance halls opened, authorities in places like New York City declared that only people with proof of vaccination would be admitted. People were eager to eat out and be entertained, so this was another reason to get the jab. Vaccination cards were checked on entry so that everyone could be "safe."

While covid is the most current example of this grotesque propaganda/misinformation, it is all too common in healthcare and pharma, as I have shown for example here for saturated fat, here for cholesterol and here for hypertension. What's new in covid is the level of coercion involved.

Relative risk, absolute risk and Number Needed to Treat (NNT)

The widely used number for a vaccine called "efficacy" is technically "relative risk" (RR). In scientific papers, it's typically a number like .05, which means that compared to the number of people who got sick without the vax, just .05 of the vaxed got sick. This is translated to saying 95% of the vaxed avoided sickness compared to the unvaxed who got sick. While technically true, it is NOT about your chances of getting sick or staying well. It means relative risk, which is how much better the vax is compared to those who had no vax and got sick, independent of the number of people in the study.

Let's go back to winter coats. When people go out in the cold, they put something on to keep warm. Sometimes the coat doesn't keep some of them warm enough. Suppose the august health authorities got real worried about people dying of the cold without adequate protection. Huge amounts of time and money were spent developing what the developers thought was a great winter coat. Never mind that, for various reasons, the vast majority of people weren't getting cold. They went to a northern football stadium near the end of play-off season (winter). They got everyone entering at half the entrance gates to wear their wonderful coat and everyone who entered at the other half to wear a fake, ineffective version of the coat (the placebo) on top of whatever they were already wearing. At the end of the game, they briefly interviewed and temperature-measured everyone who left, noting which version of the coat they wore.

Let's suppose that 20,000 people went to the football game, with 10,000 getting fancy new coats and the other 10,000 getting fake coats. Suppose 10 people wearing the fancy new coat got cold, while 100 people in the fake coat group got cold.

First let's calculate the number everyone talks about, efficacy, technically known as Relative Risk (RR). RR in this case is 100 minus 10 divided by 100 = 90% efficacy. The wonderful coat did much better when added to what people were already wearing, about ten times better than the fake coat (placebo)! This is the number everyone thinks means that 90% of the people who take the vax won't get sick. Except it doesn't mean that. The key to understanding that is that RR has NOTHING to do with the size of the group, the number of people getting poked.

So let's calculate Absolute Risk (AR). In this case, of the 10,000 in the fake coat (placebo) group, 100 got cold, which is 1 in 100, for an AR of 1.0%. Your chances of avoiding getting cold without the fancy coat were excellent -- 99 out of 100! For the 10,000 people in the fancy coat group, just 10 got cold, which is 1 in 1,000, an AR of 0.1%. The relative difference between the fake and real coats was truly big -- ten times! But the absolute difference means that 10,000 people had to get the fancy coat in order to avoid just 90 of them getting cold. The reduction in absolute risk was 1.0% - 0.1% = 0.9%.

How many people have to get the fancy coat in order for one to benefit? Scientists have a name for this. It's NNT: Number Needed to Treat, sometimes called NNTV (Number Needed To Vaccinate) when a vax is involved. While "efficacy" focuses on "relative" risk, NNT turns the absolute risk (AR) into a more relevant number -- of those getting the treatment, how many will benefit? In this case, all 10,000 football fans would have to wear the fancy coat so that about 100 wouldn't be cold, ignoring the 10 who got cold anyway. In other words, in order for one person to benefit, 100 people have to get the treatment, an NNT of 100. For the other 99, the fancy coat made no difference -- they would have been warm without it.

Getting back to reality, this means that the coats most people choose to wear protect them from getting cold remarkably well. Anyone surprised? What's the normal reaction to being in the stands and getting cold? Doing something to warm up! Jump up and down. Wave your arms. Drink a cup of hot cocoa. Get hugged. Sit on someone's lap, get wrapped in their coat. If worse comes to worse, leave for someplace warm. There are "treatments" that work just fine.

Why would anyone bother accepting and wearing the authorized coat on top of what they already have? In the vast majority of cases, they'll be fine without it, and there are things they can do if they start to feel cold. Not to mention the risk of side effects of the fancy new thing. Here and here are more detailed explanations with examples.

ARR and NNT for Covid

I used round numbers above to make sure the concept was clear. But the whole point is the real world. There is a wonderful scientific website that provides NNT's for many treatments, based completely on scientific studies. For example, here is their article on cholesterol-reducing statins. which makes it clear that no one should be taking these widely used but destructive drugs.

Let's turn to the NNT for covid. What's amazing about this is that the information about NNT for covid is hidden in plain sight. Let's look at the FDA's announcement of their EUA (Emergency Use Authorization) for the Pfizer covid vaccination. The FDA states:

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.

Later in the same announcement, the FDA gives the details about how good the vaccine is. Here is the start of the key paragraph:

FDA Evaluation of Available Effectiveness Data 

The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants ...

This gives the key point of (relative) effectiveness: it's 95% effective! Hooray, we've got it! See what happens when you keep reading:

... with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. 

First, let's look at the chance of getting covid without getting vaccinated; it's 162/18,325 = 1 in 113. Fewer than 1% of the placebo group got covid! And of those 162 cases, just 3 were classified as severe, so just 1 in over 6100 unvaxed people got severe covid. The numbers to achieve the benefit of vaccination aren't much different. The NNT is over 1 in 110 -- over 110 people had to take the vaccine for one person to avoid getting covid! Yes, the relative benefit is huge, but in absolute terms, less than 1% of people are actually helped by getting jabbed.

Note also that there was zero evidence that the vaccine prevents an infected person spreading the infection.

Is this the case only for Pfizer? A group of French scientists calculated ARR and NTT for the leading Covid drugs, based solely on the published studies of the trials of those drugs. Here is a summary and here is the study published in a scientific journal. It deserves much more attention than it seems to have gotten because of its focus on NNT.

Let's jump right to the key table.

The first drug, Pfizer, has a terrific efficacy (RR), listed there as 0.05, but normally reported as 95%. Everyone (including me, when I first saw it), thinks that means that taking the Pfizer vax means there's only a 5% chance of getting covid, right? It works great! Now look at the NNT, 141. That means that for each 141 people who are vaxed, just one benefits by not getting covid!! It makes common sense: there were 21,728 people in the control group (people who got shots that were placebos), and only 162 of them got covid,

You might think that relative and absolute risk are related, but the third drug, AstraZeneca, makes clear that they're not. AstraZeneca had efficacy (RR) of 0.30, normally reported as 70%, which is dramatically worse than Pfizer's -- why would anyone choose it? But AstraZeneca has an NNT of 83, which means that your chances of the AstraZeneca vax helping prevent covid were much better than the Pfizer vax. But even with the better NNT, chances are extremely high that you wouldn't get covid, with or without the vax.

The issues I describe here are not radical or new. The paper above was notable only in that it covered all the major covid vaccines; other doctors and scientists have publicly pointed out the same facts. For example, here is a note by a doctor published in the BMJ shortly after the trial results were first published.

Conclusion

After learning about efficacy, absolute risk and NNT, your understanding of what it means for a treatment to be "effective" changes radically. Absolute risk and NNT are at least as important. Authorities should discuss all these number prominently.

 

Blood Pressure Pills can make you Blind

As a direct result of ridiculous, anti-scientific standards, pills to lower blood pressure are the mostly widely prescribed pills in the US, with over 100 million people supposedly cursed by the “disease” of hypertension. Did you know that there’s a never-refuted medical study published by the American Academy of Ophthalmology and sponsored by the National Eye Institute (part of NIH) showing that taking those pills greatly increases the risk of going blind? I didn’t think so.

AMD: Age-related Macular Degeneration

More than 11 million people in the US have this disease. It mostly affects people 60 and older. The most common variety of it – dry AMD – is progressive and has no cure. Eventually it leads to complete loss of vision. Here is the NEI description of the disease, its causes, prevention and non-cures. You will notice that there is NO mention of blood pressure medication.

I have described the largely suppressed side effects of blood pressure medication, and my path to freedom, with the result that I'm not taking the pills and I'm healthier. Two years ago I was diagnosed with early stage AMD. After resolving the issue with harmful blood pressure pills, I decided to see if the pills also impacted AMD. While it wasn't too hard to find out about the side effects of blood pressure medications, including the ones related to heart health I experienced, I hadn't seen anything about vision in general, much less AMD. I decided to look harder.

I mostly found things like this from the Cedars-Sinai website:

In other words, they don't really know. And they clearly state that "uncontrolled high blood pressure" -- in other words, failure to take blood pressure medicine when you "should" -- is a cause.

OK, let's go to the professionals. the American Academy of Ophthalmology. What do they say about blood pressure drugs and AMD?

This blows me away. The very first risk factor they list is the garbage about saturated fat. Totally wrong. This is the cornerstone of the explosion of obesity that harms so many and has nothing to do with AMD. I'm suspicious. Scanning down the list, I see one of the causes they list is "have hypertension (high blood pressure)." Not "treating" it or "taking blood pressure medications," but simply "have" it. In the linked article about high blood pressure, they simply declare that it can lead to big trouble, and "can cause permanent vision loss." OMG! I'd better start taking pills to get my blood pressure under control!

I guess it's clear. Whatever the cause of my AMD, it can't be the blood pressure pills I took for eight years.

The Beaver Dam Eye Study

Stubborn guy that I am, I kept looking. I found a little eye group in the DC area that promotes its services. I found them because my search engine surfaced two closely related blog entries on the site, one of them titled "The Link between Blood Pressure Drugs and AMD," a close match to my search string. Score! The second sentence of the post is: "If you take medication to lower your blood pressure, it’s important to know that you could be increasing your risk of developing AMD, or age-related macular degeneration." The bold was in the original!

Both blog posts give a reference to the 2014 study and extract some details, all of which I have verified. Here is the attention-grabbing sentence from the blog post: "For residents who were not taking blood pressure drugs, only 8.2 percent of them developed early AMD. For residents who took medication for high blood pressure, nearly 20 percent of them developed AMD."

The chances of getting AMD were more than doubled by taking the drugs.

Here are the highlights of the study.

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In short, thousands of people in a Wisconsin town were followed over 20 years, tracking their use of blood pressure medication and the incidence of AMD. Here is the conclusion at the top of the paper:

Conclusions: Use of vasodilators is associated with a 72% increase in the hazard of incidence of early AMD, and use of oral b-blockers is associated with a 71% increase in the hazard of incident exudative AMD. If these findings are replicated, it may have implications for care of older adults because vasodilators and oral b-blockers are drugs that are used commonly by older persons. Ophthalmology 2014;121:1604-1611 ª 2014 by the American Academy of Ophthalmology.

Whatever the chances of you getting leads-to-blindness AMD are, you increase them by about three quarters by taking widely-prescribed blood pressure pills. Still think lowering your blood pressure is worth it, particularly considering the proven facts I describe here?

So where are the headlines? Where are the cautions about the vision-killing side effects of blood pressure drugs? Where are the follow-up studies? Where are they on the websites of major public and private healthcare organizations? Nowhere, that's where they are. Nowhere!!

It's clear that this isn't just ignorance. It's suppression. Just above I showed how there's no hint of a problem with blood pressure pills on the official AAO website. When I did a full search on Google for "AMD blood pressure," instead it showed me results for "And blood pressure." I corrected it and mostly found propaganda, but did find a reference to the Beaver Dam study. When I used my favorite non-Google search engine, which I like because they don't have thousands of engineers hard at work adding bias to the results, the very first result was a direct link into ... the AAO website! ... to a news item about the Beaver Dam study! The Expert-fueled AAO organization put a brief post on their site about the study, but failed to mention it anywhere else! Not only that, when you use their embedded (Google) search facility on the site, their own post fails to appear in the results!

Why do you suppose that is? Pharma money? What about the ethics of the healing profession, not to mention their self-respect? Given the near-total suppression of the information, I suppose simple ignorance could explain the actions of most providers, along with "standards of care" that demand regular taking of blood pressure and prescribing medications according to standards. Which are wrong, not to mention destructive.

I paid to get a copy of the full study. It had important information not included in the brief summaries. Look at this extract from Table 4 near the end of the paper:

The first line is the one often quoted. Let me show the math. Of the 2714 people in the study, 295 of them (more than 10%) got AMD because they were taking the BP pills.

I took two pills for eight years. One was Amlodipine, a calcium channel blocker, which in the study nearly doubled the chance of getting AMD. I also took Losartan, an ARB, which had zero percent AMD -- not because it was innocent, but because as shown in an earlier table, almost none of the participants took it. It could be awful, but the study was too small to know.

An earlier table also showed the incredible extent of BP medication use. About a third of the participants in the youngest age group (under 64 years) took medications, while over two thirds of those over 85 were taking them. Most of whom shouldn't have been taking them at all! I  wonder, just wonder, if this could have something to do with the increasing incidence of AMD with age -- you think that's a possibility that should be studied?

Conclusion

I used to think that the pharma and the industrial food industries make mistakes, like any industry, and you have to take the good with the bad. There is certainly some good. But the more I learn, the more I discover the all-too-widespread shameless self-dealing of the industries, strongly supported by government agencies and professional authorities. They force through regulation putting misinformation on our food and our diets in hospitals, and are making billions of dollars selling pills that are standard procedure for preventative care that, instead of keeping us healthy, actively make us sick -- even to the point of making us blind -- along with numerous other problems I have briefly touched on in prior posts.

 

The Facts are Clear: Hypertension is not a Disease

The medical community, organizations and government agencies couldn't be clearer: hypertension (high blood pressure) is a silent killer. You may not feel anything wrong, but if you've got it, your risk of strokes and heart failure goes way up. Therefore it's essential to monitor and treat this deadly condition.

They're all wrong. Hypertension is not a disease that needs to be cured. It may be a symptom of a problem, but not a problem itself, just like fever is a symptom, not the underlying problem. By treating it as a disease and giving drugs to lower blood pressure, the medical establishment makes patients less healthy and raises costs substantially. With a few exceptions, we would all be better off ignoring blood pressure and most of the associated advice.

Drugs for "Curing" Hypertension

The single most prescribed drug in the US is for lowering cholesterol. But most prescriptions for a disease are to reduce blood pressure.

Here's the story with blood pressure pills.

In fact, a majority of the most prescribed drugs in the U.S. are used to treat high blood pressure or symptoms of it. That’s because 108 million or nearly half of adults in the U.S. have hypertension or high blood pressure.

Is Hypertension a Disease?

There is no doubt that blood pressure can be measured and that it varies greatly. What is hypertension? As I describe here, currently it's a systolic pressure reading above 120 (until 2017 it was above 140). There are lots of things you can measure about people. What makes this measurement bad?

There's a clue buried deep in Doctor-language, a clue that is nearly always missed -- but it's one that doctors with a basic education should know. The official name for high blood pressure is essential hypertension. What's that? Let's ask Dr. Malcolm Kendrick, a long-experienced cardiologist:

At medical school we were always taught – and this has not changed as far as I know – that an underlying cause for high blood pressure will not be found in ninety per cent of patients.

Ninety per cent… In truth, I think it is more than this. I have come across a patient with an absolute, clearly defined cause for their high blood pressure about five times, in total, and I must have seen ten thousand people with high blood pressure. I must admit I am guessing at both figures and may be exaggerating for dramatic effect.

Whatever the exact figures, it is very rare to find a clear, specific cause. The medical profession solved this problem by calling high blood pressure, with no identified cause, “essential hypertension”. The exact definition of essential hypertension is ‘raised blood pressure of no known cause.’ I must admit that essential hypertension certainly sounds more professional than announcing, ‘oh my God, your blood pressure is high, and we do not have the faintest idea why.’ But it means the same thing.

Hypertension = your blood pressure number is high. Kind of like having a high temperature, which we call a "fever," right? Wrong. When you get a fever, doctors first make an effort to determine the cause of the fever! What an idea! The fever is a clue that something is wrong, not the problem itself! Here's the real, bottom-line clue: When you treat fever you treat the underlying cause e.g. bacterial infection, NOT the fever itself! If we treated fever the way we treat hypertension, we would give drugs whose sole purpose was to lower the body temperature, ignoring the underlying bacterial infection that caused the fever. Wouldn't do any good! Maybe we'd sweat less, but the bacteria would rage away inside our bodies. But high blood pressure? Doctors ignore the cause and "treat" the symptom, which can often do more harm than good -- except of course for the drug makers, who make out just fine.

Makes me sick.

Causes of hypertension

From Kendrick:

So, why does the blood pressure rise in some people, and not in others. It is an interesting question. You would think that, by now, someone would have an answer, but they don’t. Or at least no answer that explains anything much.

Just as fever is caused by an infection (or something else), could it be possible that hypertension results from some underlying problem? Kendrick again:

Looking at this from the other direction, could it be that cardiovascular disease causes high blood pressure. Well, this would still explain why the two things are clearly associated, although the causal pathway may not be a → b. It could well be b → a.

I must admit that I like this idea better, because it makes some sense. If we think of cardiovascular disease as the development of atherosclerotic plaques, leading to thickening and narrowing of the arteries then we can see CVD is going to reduce blood flow to vital organs, such as the brain, the kidneys, the liver, the heart itself.

These organs would then protest, leading to the heart pumping harder to increase the blood flow and keep the oxygen supply up. The only way to increase blood flow through a narrower pipe, is to increase the pressure. Which is what then happens.

Over time, as the heart is forced to pump harder, and harder, the muscle in the left ventricle will get bigger and bigger, causing hypertrophy. Hypertrophy means ‘enlargement.’ So, in people with long term, raised blood pressure, we would expect to see left ventricular hypertrophy (LVH). Which is exactly what we do see.

He goes on to give lots of detail about how this takes place, if you're interested.

Correlation and Causation

There's a little problem that everyone who knows about science and statistics is supposed to know. It's the difference between correlation and causation. Two things seem to happen at the same time. They are correlated. No problem. But does one of the cause the other? That's a whole other thing, and it's super-important. At McDonald's, burgers and fries are often seen together. They're correlated. Did the burger cause the fries? Fries cause the burgers? Nope. They're just listed together on the menu and lots of people like them together.

How about knife cuts and bleeding? Definitely correlated. Causation? By looking at repeated cases of knives making cuts, you can determine that putting a knife into someone's skin nearly always causes bleeding.

This is the problem at the heart of hypertension -- except perhaps in extreme cases, hypertension can be correlated with heart attacks and strokes -- but it can't be shown to cause them in the vast majority of cases.

The range of blood pressure

The authorities don't like to talk about this, but blood pressure varies HUGELY not just from person to person, but also by age and for a single person during the day!

Here's something to give you the idea from a scientific paper:

The range of pressure for a single person can be rather larger. I just took my pressure this morning. The systolic was 126. In the previous days the readings were 159 and 139.I have taken my pressure with different devices over a year, and that variation is not unusual. It can vary that much in a couple hours, depending on my activity level.

It is well-known in the medical community that blood pressure varies naturally with age, generally rising as you get older. Has anyone documented this statistically? If they have, I can't find it. Generally, what is normal is roughly 100 plus your age, so a 50 year old man would have 150, roughly 10 less for women. Here is an interesting description of the age factor from a former NASA astronaut and doctor.

The assumed causation fails to hold

A surprising amount of modern medical misinformation goes back to the diet-heart hypothesis put forward by Ancel Keys and supported by the seven countries study. It's what led to the obesity-causing fat-is-bad diet recommendations and the ongoing harm of reducing blood cholesterol using statins. Out of the same witch's brew came the notion that high blood pressure causes heart disease.This notion was supposedly locked down by the famous Framingham study, which continues to this day.

In the year 2000, the edifice crashed when a careful review was published in the journal of the European Society of Cardiology, "There is a non-linear relationship between mortality and blood pressure." It includes references to the original Keys study and many following journal articles.

The article is prefaced by a quote that is so appropriate, I can't help but share it with you:

"For every complicated problem there is a solution that is simple, direct, understandable, and wrong." H. L. Mencken

The authors start by explaining the current paradigm:

"the relation of SBP (systolic blood pressure) to risk of death is continuous, graded and strong..." The formulation of this "lower is better" principle ... forms the foundation for the current guidelines for hypertension.

They point out that Ancel Keys himself concluded that "the relationship of overall and coronary heart disease death to blood pressure was unjustified."

They went on to examine the detailed Framingham study data.

Shockingly, we have found that the Framingham data in no way supported the current paradigm to which they gave birth.

...

Systolic blood pressure increases at a constant rate with age. In sharp contrast to the current paradigm, we find that this increase does not incur additional risk. More specifically, all persons in the lower 70% of pressures for their age and sex have equivalent risk.

Cardiologist Kendrick in his recent book Doctoring Data points out

Has this paper ever been refuted? No, it has not. Sadly, it was given the worst possible treatment that can be dished out by the medical establishment. It was completely ignored.

...

The benefits of blood-pressure lowering, whatever the level, became so widely accepted years ago that it has not been possible, ethically,[viii] to do a placebo-controlled study for a long time. I am not aware of any placebo-controlled trials that have been done in the last twenty years, or so.

A bit of sanity

The same year (2017) the AHA and cardiologists were lowering the target blood pressure for everyone from 140 to 120, a group representing family physicians published an official guideline for treating hypertension in adults age 60 and over. Their method was rigorous, taking into account all available studies. Here is their core recommendation:

ACP and AAFP recommend that clinicians initiate treatment in adults aged 60 years or older with systolic blood pressure persistently at or above 150 mm Hg to achieve a target systolic blood pressure of less than 150 mm Hg to reduce the risk for mortality, stroke, and cardiac events. (Grade: strong recommendation, high-quality evidence).

What a breath of fresh air! And completely in line with this data-driven review that showed that a large number of people taking anti-hypertensive drugs just 1 in 125 were helped (prevented death), while 1 in 10 were harmed by side effects. Also in line with this careful study of people with elevated blood pressure in the range of 140-160; the study showed that none were helped by drugs, while 1 in 12 were harmed.

BTW, if you're not familiar with the concept of NNT, you should learn about it. It's crucial.

Hypertension Drugs can hurt you

Doctors dish out hypertension drugs like candy. It's often the case that two different kinds of drugs will be required to get your blood pressure to "safe" levels. For reasons that don't seem to be studied, it's rare indeed for doctors to mention side effects; yet in repeated studies, the generally data-suppressing researchers can help but mention that the side effects are so bad that roughly 10% of study participants drop out of the study! (See above for references.)

There are good lists of side effects at Drugs.com. Here's some information about Amlodipine:

Side effects requiring immediate medical attention

Along with its needed effects, amlodipine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine:

More common

• Swelling of the ankles or feet

Less common

• Chest tightness
• difficult or labored breathing
• dizziness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest

Rare

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chills
• cold and clammy skin
• cold sweats
• confusion
• cough
• dark yellow urine
• diarrhea
• dilated neck veins
• dizziness or lightheadedness when getting up from a lying or sitting position
• extra heartbeats
• fainting
• fever
• itching of the skin
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• numbness and tingling of the face, fingers, or toes
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• painful or difficult urination
• pale, bluish-colored, or cold hands or feet
• pinpoint red or purple spots on the skin
• red, irritated eyes
• redness of the face, neck, arms, and occasionally, upper chest
• redness, soreness or itching skin
• shakiness in the legs, arms, hands, or feet
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• sudden sweating
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• trembling or shaking of the hands or feet
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weak or absent pulses in the legs
• weakness in the arms, hands, legs, or feet
• weight gain
• yellow eyes or skin

Then there are the ones judged to be less severe:

Side effects not requiring immediate medical attention

Some side effects of amlodipine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach
• belching
• feeling of warmth
• heartburn
• indigestion
• lack or loss of strength
• muscle cramps
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain

Those are the issues with just one of the many hypertension drugs, one of the most widely prescribed!

Conclusion

Blood pressure varies greatly, reflecting the human body's amazing self-regulation systems. In the vast majority of cases, blood pressure goes up with age. Lowering it by drugs does more harm than good. Except perhaps in extreme cases, high blood pressure does not cause disease. When pressure is extremely high, a search for the cause should be made. The ongoing focus on hypertension as a disease reflects nothing but the stubborn refusal of the medical establishment to admit that they were wrong, and of the pharma companies to give up a lucrative market.