The Black Liszt

Summary: The Business of Healthcare, Medicine and Insurance

After spending years learning about the software used in medical offices, hospitals and insurers, I came to the conclusion that healthcare technology is the trailer park of the computer world.

I have since realized that I was wrong in the comparison; trailer parks actually work to house their inhabitants, effectively and inexpensively, unlike most medically-related computer systems. Trailer parks of the world, I humbly apologize.

https://www.blackliszt.com/2015/12/healthcare-problems-and-opportunities.html

 

Healthcare Computers and Software

Hospitals have trouble keeping their computers working. When they fail, they often try to hide the failure, which puts patients at risk.

https://www.blackliszt.com/2015/05/healthcare-it-disfunction-the-secret-computer-outage-at-mount-sinai-hospital.html

In contrast, other institutions let their customers know about computers failures and even apologize for the inconvenience.

https://www.blackliszt.com/2015/05/computer-troubles-at-the-hospital-and-at-the-symphony.html

The contrast between putting meals on the table and assuring that data is available for use on providers’ screens couldn’t be more stark.

https://www.blackliszt.com/2015/05/meals-at-downton-abbey-and-it-in-healthcare.html

Even when their computers are working, the people in charge brag about the fancy new things they’re doing instead of assuring that basic processes like patient scheduling work as intended.

https://www.blackliszt.com/2014/07/innovation-made-simple.html

There’s no doubt that hospital computer systems are a horror show that hurt patients and that managers try to hide. But there’s a far worse largely hidden problem leading to patient deaths.

https://www.blackliszt.com/2017/05/hospital-computer-disasters-and-iatrogenic-disease.html

Is making systems work reliably and well a wide-spread problem? Yes. Are there proven solutions? Yes. Hospitals do an outstanding job of ignoring them.

https://www.blackliszt.com/2023/04/summary-software-quality-assurance.html

 

Electronic Medical Records (EMR)

The data about your health and health history are essential for guiding medical interactions of any kind.  The quality of the data is essential. All too often, the data is wrong or missing.

https://www.blackliszt.com/2016/06/healthcare-innovation-emrs-and-data-quality.html

Most medical organizations have EMR’s and also loads of paper records, which both patient and provider fill out.

https://www.blackliszt.com/2016/06/healthcare-innovation-emrs-and-paper.html

Have you ever tried to get your own medical records from the institution that has them – your records?? Nightmare.

https://www.blackliszt.com/2016/06/healthcare-innovation-getting-our-data-out-of-emr-prison.html

They all say they have easy-to-use systems to enable patients to get their own records. Hah. Just try it.

https://www.blackliszt.com/2018/01/who-owns-your-health-data.html

Here are details of the horrible obstacles a major systems places between the patient and his “easy-to-access” data.

https://www.blackliszt.com/2018/10/medical-testing-getting-the-results.html

https://www.blackliszt.com/2018/10/medical-testing-getting-the-results-2.html

Most people have been to more than one institution, each with its own records about you. EMR interchange is supposed to make it easy for the place you’re visiting to get your records from other places.

https://www.blackliszt.com/2016/10/healthcare-emr-why-portability-matters.html

https://www.blackliszt.com/2016/07/healthcare-innovation-how-to-achieve-emr-interchange.html

EMR interchange works? Patients sometimes have to go to ridiculous lengths to get essential data from where it is to where it’s needed.

https://www.blackliszt.com/2016/09/healthcare-emr-interchange-breakthrough.html

The bottom line is that medical institutions should prioritize giving patients their data. There should be an EMR app for your data just like there are money apps like Venmo and Zelle for your money.

https://www.blackliszt.com/2016/01/i-want-an-emr-app.html

One of the many reasons for EMR nightmares is that the software is a huge problem and “just” buying and installing it is a job of “epic” proportions.

https://www.blackliszt.com/2016/05/healthcare-innovation-emr-procurement-is-broken.html

 

Healthcare Business: Scheduling, Testing, Billing and Payment

Medicine is all about helping people get and stay healthy, but it’s also a business.

https://www.blackliszt.com/2018/07/medicine-as-a-business-overview.html

Scheduling, billing and payment are different for medical care than any other service we require. Here are highlights of the differences.

http://www.blackliszt.com/2018/07/medicine-as-a-business-billing-overview.html

You need to get a simple test like an X-Ray? No problem. Bad data at the provider, the insurer and the EMR will ensure that lots of time is wasted.

https://www.blackliszt.com/2017/01/my-cat-taught-me-about-the-state-of-healthcare-provider-data.html

Scheduling sounds simple, right? Maybe for a cat at a vet, but not for a person at a hospital.

https://www.blackliszt.com/2019/04/whats-wrong-with-medical-scheduling-and-why-it-matters.html

The amount of time and effort on everyone’s part to schedule a medically-required MRI is amazing. Without patient persistence, it won’t happen.

https://www.blackliszt.com/2018/09/medical-testing-scheduling-the-test.html

Covid testing illustrated the widespread problems with scheduling – it was about the systems and software, not Covid.

https://www.blackliszt.com/2021/12/the-nightmare-of-covid-test-scheduling.html

Once you’re scheduled, you have to go to the right place, which can be its own adventure. Fortunately, you can usually rest afterwards by filling out reams of paperwork.

https://www.blackliszt.com/2016/10/hospital-wellness-innovation-breakthrough.html

For costlier tests like MRI’s, the extent of useless, costly processes is mind-boggling.

https://www.blackliszt.com/2018/09/medical-testing-doing-the-test.html

MRI’s are an amazing technology. The reports from the specialists are something else again. It turns out that in spite of endless years of training, there are no standards for reading and reporting – even “simple” things like the size of a tumor.

https://www.blackliszt.com/2018/11/medicine-as-a-business-medical-testing-5-the-results.html

What I’ve described aren’t one-off’s. The problems from scheduling to getting the results are business-as-usual in the world of medicine.

https://www.blackliszt.com/2022/02/medicine-as-a-business-medical-testing-6-another-test.html

And then there’s billing. I went for an MRI, and got bills from different places with bad information and a broken online payment system.

http://www.blackliszt.com/2018/07/medicine-as-a-business-billing-1.html

The second bill was also a mess of bad data, with an offer to pay online but the bad data prevented me from paying. So I wrote a check.

http://www.blackliszt.com/2018/07/medicine-as-a-business-billing-2.html

When you dive into the insurance payment part, the nightmare morass of bad data and bad software is overwhelming. Business as usual.

http://www.blackliszt.com/2018/07/medicine-as-a-business-billing-3-insurance.html

My health insurer announced a major new service to help patients pay provider bills. Strike out.

https://www.blackliszt.com/2019/02/giant-health-insurer-reveals-patient-billing-break-through-or-is-it-a-break-down.html

Here is a summary of what’s wrong with medical billing and insurance payments.

https://www.blackliszt.com/2018/08/medicine-as-a-business-billing-4-whats-wrong.html

 

Medical Costs

Medical costs are outrageous. They don’t have to be.

Hospitals could stop spending money on useless fancy innovations and concentrate on simplifying and automating the everyday nuts and bolts of the business.

https://www.blackliszt.com/2014/07/innovation-made-simple.html

Removing the regulatory straight-jacket on medical equipment would be huge.

https://www.blackliszt.com/2016/12/regulations-that-enable-innovation.html

https://www.blackliszt.com/2020/05/heres-how-the-fda-can-reduce-medical-device-costs-while-improving-healthcare.html

https://www.blackliszt.com/2023/01/how-to-reduce-the-cost-of-medical-imaging-and-pacs.html

Some of the same principles apply to drug discovery and costs.

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

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

 

Health insurance

Health insurance companies maintain a huge trove of your personal data. They are incapable of keeping it secure, and bungle the response when there’s a major breach they can’t cover up.

https://www.blackliszt.com/2015/02/my-anthem-account-was-hacked.html

https://www.blackliszt.com/2015/02/the-anthem-of-cyber-insecurity.html

Health insurers think providing patients incentives to keep healthy is a win all around. Sadly, their incentives tend to be embarrassing failures. Here’s an example with giving a Prepaid debit card.

https://www.blackliszt.com/2018/11/patient-incentives-in-healthcare.html

The marketing departments of health insurers want to communicate with patients to make good things happen. Most of them appear never to have heard of the concept of personalization.

https://www.blackliszt.com/2019/02/patient-outreach-by-health-insurers-case-study.html

https://www.blackliszt.com/2022/04/health-insurance-company-tries-to-keep-me-healthy.html

The same marketing gurus reach out to patients for feedback and reveal that they flunked Marketing 1.01

https://www.blackliszt.com/2021/05/anthem-needs-my-feedback-reveals-deep-problems.html

Here’s an example of why they get terrible response rates when asking for customer feedback.

https://www.blackliszt.com/2019/02/adventures-with-health-insurance-software-customer-feedback.html

Every serious company has to have an app, right? It makes sense that the insurer would spend piles of money to build one that customers hate.

https://www.blackliszt.com/2021/02/why-cant-big-companies-build-or-even-buy-sofware-that-works.html

 

AI and fashionable algorithms in Medicine

There are many examples of AI in healthcare in this summary of AI in general.

https://www.blackliszt.com/2023/07/summary-ai-machine-learning-big-data-math-optimization.html

Here are some of the AI posts relevant to healthcare. A major theme of AI in healthcare is that well-paid managers are desperate to keep up with the AI fashion, and spend lots of money and generate lots of publicity about how wonderful they are. The trouble is that there are simpler, common-sense things that are fully understood that could be done right away that would yield major improvements in patient health; these things are too often ignored or neglected.

https://www.blackliszt.com/2015/07/cognitive-computing-and-healthcare.html

https://www.blackliszt.com/2015/08/human-implemented-cognitive-computing-healthcare.html

https://www.blackliszt.com/2016/05/healthcare-innovation-can-big-data-and-cognitive-computing-deliver-it.html

https://www.blackliszt.com/2016/09/healthcare-innovation-from-washing-hands-to-ai.html

https://www.blackliszt.com/2017/06/how-to-avoid-cutting-off-breasts-by-mistake.html

https://www.blackliszt.com/2018/08/getting-results-from-ml-and-ai-4-healthcare-examples.html

Be Healthy and Don't Schedule Your Heart Health Visit

As I write this, it's Valentine's Day and my doctor is after me! Valentine's Day is all about hearts getting together, so it makes sense that my heart should be healthy and ready for whatever comes along, right? I found this email in my inbox:

Awww, it's American Heart month too...

They even took the trouble to make a pretty graphic, with lovers getting together, hopefully with healthy hearts:

What are these numbers they're talking about?

Ah, so it's those nasty numbers you hear about so often: blood pressure, glucose and cholesterol. Oh well, who wants to die of a heart attack? Not me! Let's see what I'm in for.

They talk about the three numbers I've got to know.

All the major authorities agree that high blood pressure is a horrible thing that must be measured regularly and controlled. They really want us to be healthy -- that number of 120 was just lowered to that about 6 years ago from the 140 number it had been for many years. A huge number of people take blood pressure medications to control the pressure and get the number down.

But there's a problem. Not only is hypertension NOT a disease, taking the pills more than doubles your chances of going blind. The more "routine" side effects of the pills can be awful, even harming the heart. And they don't even help you live longer!

Let's hope the next number is worth checking.

With rare exceptions, measuring this is a way of telling how far you are to having diabetes. Which is mostly caused by bad diet and life habits a.k.a. being fat. So what does the doctor do? Maybe they'll talk about that. But the usual practice is to put you on a drug.The data shows that almost no one is helped and that a large number taking drugs are harmed.

Now we've gotten to the last number, the most mysterious of all, the one about "bad" cholesterol.

Like blood pressure, this is one where ALL the medical authorities are united: it's bad and you've got to do something about it -- basically take pills.

There's just one little problem: taking the pills and lowering your cholesterol does NOT help you. It does help pharma -- to the tune of billions of dollars. But you? Nope, sorry. And let's not talk about the fact that serious side effects are experienced by something like 10% of the people who take the pills, and that it demonstrably (by the numbers), shortens the life of women. See this for the numbers, facts and studies that demonstrate this, studies that have never been refuted.

Is it just my provider? No, they're all into it. I got this random email from ZocDoc, a place that tries to "help" you find a doctor and make appointments:

They're all in on it.

Conclusion

I admit it's hard to think that all these prestigious doctors and major institutions could be so wrong. But this isn't an exception. A massive study on hundreds of thousands of people has shown that checks of this kind -- including these specifically -- do not help people live longer, healthier lives. See this for context and summary, and this for the study itself.

There are many wonderful, health-making things doctors can do to help patients. The items mentioned in these Valentine's Day emails don't happen to be among them.

Be Healthy And Don't Schedule Your Annual Wellness Visit

It came again. Of course it did. It always does. What came?

The polite command to get into my doctor for what used to be called a "physical" and now most often is called something like an "annual wellness visit." Why do I have to visit a doctor to "make sure you're up-to-date on all health checks and screenings?" Simple: we patients don't care about our own health and fail to track elementary things. So we need to be told and then have our arms twisted to submit to various forms of testing. It's important -- early detection saves lives!!

What's included?

Here's what was in my annual thingy, which is probably similar to the one you got:

Draw some blood. Ask how depressed you are. Check whether you're had all the covid and other shots you're supposed to get. Colon cancer is terrible -- make sure you've had the colonoscopy you're supposed to have!

It's interesting that I also sometimes get something like this from my medical insurance company. It costs them money -- why would they send me to the doctor? I guess they really care -- or maybe they think prevention will be cheaper than cure. That seems to be what everyone thinks.

Houston, we've got a problem

Let's step back. Why this emphasis on health checking? It wasn't a big deal decades ago. Has something happened?

You bet something has happened. In spite of all the things pushed by public medicine, it's getting worse instead of better. Here are some highlights.

U.S. life expectancy fell to 76.4 years in 2021, the lowest since 1996, erasing a quarter-century of progress. By the end of 2021, the life-expectancy gap between the U.S. and Germany had widened to 4.3 years, and between the U.S. and France to six years.

...

The U.S. 2020 death rate from overdoses of 277 per million compared unfavorably with ... Germany’s 19 per million, and France’s 7 per million.

...

Between 2000 and 2020, the rate of obesity in the U.S. has risen from 30.5% to 41.9%. It is now the highest of any developed country and a stunning 10 times the rate in the lowest, Japan.

This is awful! No wonder we're getting harangued about getting to the doctor's office -- we're getting sicker and dying younger! Better do something about it!

What good does this checking do?

Has anyone run a trial to see if this massive testing and prevention actually makes anyone live a longer, healthier life? You'd think it would -- after all, doing sensible things like preventing getting too cold In the winter seems like it's better than trying to fix frost-bitten fingers and toes. It turns that many such trials have been run! And there's even a meta-analysis of all the trials, involving over 182,000 patients! Let's see what was discovered:

(NNT = Number Needed to Treat, i.e., the number of people who need to be treated in order for a single person to benefit. For more see this and this.)

Here are the highlights:

This Cochrane Collaboration review compared health checks, defined as “screening general populations for more than one disease or risk factor in more than one organ system,” to no health checks in a general, non-geriatric adult population. The authors included 14 trials of 182,880 subjects, testing three outcomes primarily: overall mortality, cardiovascular mortality, and cancer-related mortality.

Nine trials found no difference in overall mortality (7.4% in the intervention group and 7.5% in the control groups) with no observed heterogeneity across studies. Subgroups included less than or greater than five year follow up, old versus recent trials, USA versus European cohorts, and others, with no differences noted.

Health checks also failed to improve cardiovascular-specific mortality in eight trials, at 3.8% in the intervention group and 3.7% in the control group, though heterogeneity for this comparison was substantial. This was attributed to varying definitions of cardiovascular disease (myocardial infarction, stroke, etc).

For cancer-specific mortality rates were 2.1% in both intervention and control groups with moderate heterogeneity.

For secondary outcomes no difference was found in morbidity, hospitalizations, disability, physician visits, specialist referrals, absence from work, or patient worry, however there was a slight increased sense of self-health among those assigned to checkups.

You would think that an ounce of prevention is worth a pound of cure. There's no doubt that preventing getting cold is better than recovering from frostbite, but apparently it's not the same for medical testing.

What's being checked?

Everyone's list is probably a bit different, but let's check out the one I got as a typical wellness list as shown above.

First on the list was cancer screenings.

• Breast cancer. Getting a mammography seems to make sense, since catching something early sounds like a good idea. Bottom line: no one has a longer life because of the tests and lots of people are hurt by them. See this.
  
• Colon cancer. It's a terrible disease. you don't want to get it. Colonoscopies are supposed to not only detect it early and even help prevent it. Good idea! Sorry, not a good idea. In spite of tens of billions a year spent on prevention, the only controlled trial ever conducted, a big multi-country one, clearly shows that colonoscopies do NOT help you live longer. See this for the facts.
  
• Cervical cancer. According to the National Cancer Institute, cervical cancer was only 0.7% of all new cancer cases and deaths in 2022. Most women who get it survive 5 years or more. It's a tiny fraction, for example of liver cancer. And the recommended test, for HPV, has huge numbers of false positives. Why is this even on the list?
  
• Lung cancer if you've been a smoker. There have been lots of trials, careful tests. People have tried safer methods of testing than X-rays.  They don't work. See this and this for the details.
  

Second was vaccinations.

• The one they mention is the "yearly flu shot." This may be the mostly highly promoted shot on the planet. Sadly, there is conclusive evidence from scientific studies, including the CDC, that flu shots do not help. The studies show that not only are flu shots useless, they are a bad idea for old people. See this for my review of the details.
  
• Here is a discussion of "efficacy" in vaccines and what it really means, with specific illustration of covid vaccines. Unless you go into NNT for benefits and harms, you won't understand vaccines.

Third amounts to a blood test.

• Blood pressure. Everybody seems to accept that so-called hypertension (a.k.a. high blood pressure) is a disease. A huge fraction of the population take pills to "control" it. Not only is hypertension NOT a disease, taking the pills more than doubles your chances of going blind. The more "routine" side effects of the pills can be awful.
  
• Diabetes. Type 2 diabetes is not a good thing. Often it can be controlled by losing weight. Drugs are often prescribed. The data shows that almost no one is helped and that a large number taking drugs are harmed.
  
• Cholesterol. High cholesterol in the blood is supposed to lead to heart attacks. Why not take pills to keep it down and live longer? Simple: random controlled trials conclusively show that not only doesn't reducing cholesterol help, the pills are actively harmful in serious ways. See this.
  

Bottom line: these things shouldn't be tested for or, worse, "cured."

Conclusion

If you've got a medical problem and need help, by all means contact your doctor! There may be preventative or screening things I haven't covered here that are valuable, particularly with inheritable conditions. But screening overall doesn't help as the study I quoted above shows, and the screening things I've covered here as examples are the most common, and the data shows they do more harm than good. Your health is ... owned by you -- own it! And get help when you need it.

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.

 

How to Cure AMD Macular Degeneration

AMD is the leading cause of visual impairment in the US. It hits many people as they age and causes vision to worsen to the point of blindness.

First the bad news: all I have is some evidence and common-sense logic that there MAY be a cure. Now the good news: there is a never-refuted major study that shows that people who take pills to reduce their blood pressure get AMD at more than twice the rate of those who don't, and there is anecdotal evidence (needs more study to confirm) that stopping taking the pills causes the AMD to reverse (not stop or slow down -- reverse) its progression. Do you think that's worth digging into? And at least letting everyone who takes BP medications that there is a good chance that at least 10% of them will needlessly go blind with AMD?

Blood Pressure Pills

All the medical authorities are united in the importance of fighting the “silent killer” of blood pressure that’s too high, i.e., hypertension. I’ve described in detail that what doctors call ‘essential hypertension” is NOT a disease.

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.

I started taking them eight years ago as a small part of my fight against a cancer that I had.  Last year I started experiencing symptoms that could have been evidence for heart problems. I had extensive testing and did research on my own. My heart was good but I discovered that my symptoms were side effects of BP pills, widely reported by people but ignored by doctors. I stopped taking the pills and my symptoms faded away to nothing. I tell the story here.

Blood Pressure Pills and AMD

Then I wondered if the pills could possibly have something to do with my AMD that was first diagnosed about three years ago. I studied hard and came up with nothing. Big authorities said that having "uncontrolled" hypertension could cause it along with "bad" diet. In a story I tell here, I discovered here’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.

The study remains on-line but is shockingly difficult to find. I found only one eye doctor group that mentions it. You would kinda think that they would recommend getting off of BP pills, don't you think?

Blood Pressure Pills and AMD

I had detailed pictures of my macula clearly showing the drusen that are the things in the eye that hurt vision in AMD. I just went to the same doctor, who took another set of careful pictures so we could compare them to the ones from a year ago, while I was still taking BP meds. I stopped taking the pills a bit more than six months ago.

Below are pictures my doctor took of a section of the left eye. (You may have to click the picture to see it all, particularly the wavey drusen on the right.) The top picture is from a year ago and the bottom a couple days ago. The drusen are the wavey parts of the two white curves on the right.

As she said, the central drusen got larger but the ones in the periphery diminished significantly.

Generally speaking, drusen either stay the same size or they grow. Mostly grow. That's why AMD is progressive and no one has found a way to make it stop or slow down, much less reverse course. Here's an example of drusen shrinking. Why?

If you smoke, your chances of getting lung cancer are high. If you stop smoking, the chance of getting cancer goes down. If you're an alcoholic, your chances of terrible liver damage go up the longer you drink. If you stop drinking, your liver usually stops getting worse and often gets better. Is it reasonable to think that if taking BP pills doubles your chances of getting AMD as demonstrated by the Beaver Dam study, that stopping taking the pills would result in good things happening with AMD? We need a study to prove it, but it's a reasonable assumption. It's particularly reasonable given the proven fact that taking BP pills more than doubles the chance of getting AMD as you age.

Conclusion

I thought blood pressure pills were benign, something you probably had to take when you got older to lengthen your stay on earth. It's what the whole medical establishment and nearly every doctor says. What's a visit to the doctor without taking your BP?

They're wrong. The evidence that they're wrong is available, but they're no more willing to change than they were in the cases of antiseptic surgery or blood-letting.

That the horrible side-effects of BP pills are universally denied by doctors and bad enough. But making you blind? If there were any conscience in the medical establishment, they would defy the pharma companies and immediately create studies to validate this. Serious mining of the RWE in centralized medical charts that should show the relevant data points would be a good start.

 

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.

 

The Medical Treatment of Obesity

In a prior post I asked why there is no search for the origins of the widely-acknowledged obesity epidemic that harms so many people. I suggested that the data shows that there is an obvious cause: the government nutrition recommendations that pervade our society and prominently stated on packaged food. The overweight/obesity numbers started their steady growth shortly after these were promulgated and people followed the recommendations.

Ignoring overwhelming evidence, the authorities continue the health-destroying drumbeat of bad eating advice. Now, the medical people who are charged with dishing out this destructive nonsense are being criticized for making the people who follow their advice feel bad. When will it end??

Smoking

When I was growing up, I saw advertisements and commercials for smoking.

The Marlboro Man was particularly memorable. The ad campaign generated billions of dollars of sales.

The tobacco industry was always concerned about their image; throat irritation from smoking was a well-known side effect, not to mention the growing number of deaths by lung cancer. So ads were created and widely shown claiming the support of the medical profession for smoking, for example:

We know today that smoking causes lung cancer. It wasn't until 1964 that the Surgeon General declared it the cause, and many years passed before other measures were taken. For example, United Airlines was the first to create a non-smoking section of the plane, in 1971. It took until 1990 for smoking to be banned on domestic flights in the US, and later for international flights.

Obesity

So where do we stand with obesity compared to smoking? I would estimate we're at about 1960. The government is hard at work revising the nutritional guidelines most recently updated in 2017, and the drafts that have come out strongly resemble the equivalent for nutrition of what for smoking would be: "smoking unfiltered cigarettes is just fine, but don't smoke too many a day, and make sure you practice breathing exercises regularly to keep your throat and lungs healthy."

As a reminder, the science is solidly behind consuming whole-fat dairy, eggs and meat, while minimizing sugar and carbs. Here is an example of the current version of nutritional insanity:

Sugar-loaded Frosted Mini Wheats and Lucky Charms are better than a whole egg, and ice cream with nuts is better than ground beef. Sure! I wonder what the role of the processed food industry has been in all this...?

Doctors and obesity

Doctors are required to dish out their profession's broken nutritional recommendations to one and all. They are particularly supposed to give good advice to the obese people those recommendations continue to harm. But now there's a new twist -- doctors are being blamed for the on-going troubles of their obese patients!

Obese people are often “weight-shamed” by doctors and nurses — worsening their problem and causing them to wrongfully blame themselves for the condition, according to a new study.

Fat-shaming by medical professionals leads patients to feel humiliated and anxious about appointments — making them more likely to overeat, according to research from the University of London.

Researchers examined 25 previous studies centered on 3,554 health professionals and found evidence of “strong weight bias” — including that doctors and nurses tend to assume overweight people are lazy, according to the report, published in the journal of Obesity Reviews.

“[They] believe their patients are lazy, lack self-control, overindulge, are hostile, dishonest, have poor hygiene and do not follow guidance,” Dr. Anastasia Kalea, who authored the study, told the UK Guardian.

So what should physicians do?

The study concludes that medical professionals should be trained in “non-stigmatizing weight-related communication.”

Tam Fry, the chairman of the National Obesity Forum, said doctors and nurses should take responsibility for the role they play in the UK’s obesity epidemic.

“It is shameful that the condition continues to be regarded by health professionals as being solely a personal problem, little to do with them and it’s disgraceful that they stigmatize patients for being overweight,” said Fry, who was not involved in the study. 

“This is the last thing a patient wants to hear from professionals who they trust will help them.”

It's clear that physicians are stuck between a rock and a hard place. If they dish out their profession's nutritional advice, the obese person will stay over-weight. If they dish out the limit-calories-exercise-more stuff, most people just can't keep it up -- as we know from the obesity numbers. And if they bend over backwards to make sure to avoid giving obese people the slightest impression that their own actions might, just maybe, have something to do with their condition, then they've really blown it! Can't talk and what they're told to talk doesn't work.

Conclusion

Remember what happened with smoking -- the decades it took for the cancer-causing truth about it came out, got proven, and the more decades it took for it to be acted on. We're still in the early innings here with nutrition in general, and saturated fat in particular. We can only hope that sanity and science can move more quickly this time.

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.

T

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 Destructive Treatment of Hypertension

I’ve talked about how all the medical authorities are united in the importance of fighting the “silent killer” of blood pressure that’s too high, i.e., hypertension. I’ve described in detail that what doctors call ‘essential hypertension” is NOT a disease. Fighting the non-disease of hypertension is an ongoing bonanza for doctors and the drug companies while leading to serious problems for patients.

In this post I’ll describe my personal experiences that led me to these observations. What happened to me was not unusual, and others have had it worse than I have.

Getting Cancer and Hypertension

Eight years ago I developed a rare form of cancer, desmoid tumor, of which there are about a thousand cases a year. I was treated with drug infusions. The drugs sometimes have bad effects on the heart, so I received tests and a consultation with a NYC cardiologist. She told me I had high blood pressure that must be treated immediately. I was surprised since my reading had always been low, but complied, ending up taking daily doses of Amlodipine and Losartan.

This was unusual for me, because I normally dive in and check for myself everything that’s important to me. I didn’t in this case. I was consumed with my study of my rare cancer and the ineffective early advice I got. I found the one doctor in the country who knew how to treat it. The blood pressure seemed like a bump in the road at the time. My bad.

I kept up with the daily drugs after that, with new prescriptions issued by my primary care doctor with minor adjustments. Not once did any doctor mention anything about side effects. I felt OK and did no research.

About a year ago I started monitoring my blood pressure myself because I began experiencing symptoms it was hard to put a finger on. I knew the drugs I was taking were generics and had discovered the widespread corruption of generic drug makers and the ineffectiveness of the quality monitoring conducted by the FDA. I asked my primary care doctor for prescriptions for the branded versions of the drugs, which I hoped were more carefully monitored. I discussed in detail with my local CVS pharmacist, who ultimately was unable to get the drugs.

Symptoms of Heart Trouble

The symptoms increased. In March 2022 I had a tough time driving with symptoms that included being light-headed and a heart pulse rate that was high for me, as though I were exercising. I went to my primary doctor who gave me some tests including an EKG. With inconclusive results, she referred me to a cardiologist. The cardio guy gave me lots of tests, including an electro-cardiogram, a nuclear stress test, a week-long Holter monitor. This all took a few weeks.

Meanwhile, I did what I should have done eight years ago – dove in and studied heart function and blood pressure. It didn’t take long for me to discover – surprise! – that the symptoms I experienced were the same as side effects of the drugs I was taking, and were widely reported by patients online. I tried to get FDA data on them and discovered the great lengths the FDA goes into order to keep drug adverse reactions as secret as possible – kind of like the way medical offices say you have full access to your medical records, except that they prevent it, as I have described in detail.

I brought up the subject on my next visit with the cardiologist. He immediately dismissed the possibility. He refused to discuss it or take seriously the possibility that my symptoms were due to the drugs that he and all the other members of his profession profusely prescribe.

After that I took matters into my own hands. I stopped taking the drugs after the last test was conducted, in order to avoid confusing the results. I continued daily blood pressure readings, sometimes more often.

I finally got the results of all the tests. Nothing was wrong with me – except of course when you monitor for seven days straight, sometimes your heart beats fast. It’s scary! It’s called supraventricular tachycardia (SVT). Once or twice a day, for a dozen beats at a time and on the low end of the "fast" scale. Call 911! My valves are fine, no blockages, no Afib, etc. etc. His recommendation? Consult one of his friends to get either a pacemaker or a six hour operation to zap random bits of my heart in hopes that the scary SVT would go from 0.001% to zero. Maybe. NFW, thanks anyway, esteemed board-certified cardiologist.

My first step after stopping the drugs was to start taking a well-reviewed natural heart-health additive based on L-Arginine. After 3 weeks I was better, but not satisfied. So I just stopped messing with my body and its extremely complex mechanisms. After my body cleared out, I was much better.

The blood pressure numbers are interesting:

Average        Systolic         Diastolic

with drugs     137              64

L-Arg only     157              74

nothing          144              65

Taking no blood pressure or other drugs resulted in Diastolic numbers that were unchanged and Systolic numbers that were 7 points higher, well within a healthy range, though not according to current cardiologist drug-pushing fashion.

Side effects of blood pressure control drugs

There are lots of non-government places to learn about the side effects of the awful blood pressure drugs -- thanks, internet! No thanks at all, cardiologists! -- and even published studies that show 10% of participants in studies dropping out due to the intolerable side effects.

Here are a few samples of problems with Amlodipine from a data-rich site.

fast, irregular, pounding, or racing heartbeat or pulse

Common (1% to 10%): Palpitations, ankle edema

Amlodipine has an average rating of 3.7 out of 10 from a total of 571 ratings for the treatment of High Blood Pressure. 20% of reviewers reported a positive experience, while 61% reported a negative experience.

41% gave it 1 star out of 10

Common in reviews below: “feeling lightheaded, heart palpitations and arrhythmia”

After 35 years of taking it, “I took myself off of 2 years ago, but could not get through the withdrawals. It caused my heart to feel like it was beating out of my chest”

After starting “suddenly I felt dizziness I went to ER they admitted me to the heart hospital. I was told I needed a pacemaker. I declined.”

After strong heart beat “I attended a pre-operative assessment where I was given a routine ECG and this confirmed that I had become tachycardic while taking amlodipine. My pulse was racing at over 100 BPM”

After stopping “Five weeks later I still have the tinnitus”

After 6 years, “worse side effects have been; heart pounding/palpitations, fatigue, and increased anxiety…. I stopped taking the Amlodipine Besylate 10 mg. over 3 weeks ago and and have noticed that my energy level has increased, anxiety lessened and heart pounding decreased.”

After 18 months “… anxious. Couldn't sleep, couldn't concentrate. I noticed muscle tics all the time, heart palpitations, more joint pains, memory loss and more. …I had myself convinced I had contracted some fatal condition (ALS, MS, etc...). After every specialist I could find, we decided it was anxiety. Then one day I read someone's account of anxiety and amlodipine. …try a switch. Today I am back to my old self.”

Conclusion

I have re-learned one of life’s most important lessons: if you want to be healthy, take charge of your own health. It’s your health, no one else’s. You own it, you have to live with it. There are experts and authorities all over the place who are lined up to tell you what to do. They want you to pay them, take drugs and undergo invasive procedures. Most of these people are highly trained and well-meaning. They sometimes know things that are worth knowing. They can be of great help. It’s worth listening. But it is not worth mindlessly following their orders, because their profession’s best, standard advice is all too often wrong. WRONG. And not just wrong – actively harmful.

Once I took my health into my own hands eight years ago, I found a truly expert doctor who brought my nasty rare cancer into remission, a place where I hope it’s happy. On the path, I stupidly and without examination followed doctor’s orders about blood pressure, following advice given to nearly half the population of the US. How could it possibly be bad? Easy. The same way the nutrition advice given to ALL the US population was and remains highly destructive, leading to the ongoing obesity epidemic and widespread avoidable suffering. The same way bad science about blood cholesterol has led to the most profitable drug in pharma history, treatment which shortens lives and makes patients less healthy.

The good news is that you’re not alone. There are dedicated people devoted to discovering and putting out the facts so that diligent, self-reliant people can find out what’s best for their health, most importantly for those cases where the medical profession stubbornly clings to destructive error, as it has so often in the past. It’s your health. Own it!

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.

The Experts are Clear: Control your Blood Pressure

Most of us have heard about high blood pressure. It's one of those conditions that afflict a large number of people. Nearly half of American adults are said by the AHA to have it! You may be able to control it by maintaining a healthy lifestyle, things like avoid eating saturated fats, salt and alcohol, keeping your weight down and getting exercise. Fortunately, there are drugs that can help keep it under control.

Why should anyone care? Strokes! Heart attacks! Premature death!

Is this one of those things that floats in the air but isn't real? Let's take a look at what people who know what they're doing say about it.

The American Heart Association (AHA)

Blood pressure is all about the heart, right? So let's start with the medical association that's all about keeping our hearts healthy. They make it very clear why we should care:

Those folks at the AHA may be doctors who can't write legible prescriptions, but they were sure able to rope someone into producing a scary diagram! OK, you've got my attention. Here's the facts with blood pressure:

What can I do?? What if I maintain a good weight, eat a heart-healthy diet, cut back on salt and the rest and my BP is still scary? There are medications.

How long will you have to take your medication? Perhaps for the rest of your life.

OK, then. If that's what has to be done to avoid the things in the scary diagram above, then so be it.

More American Heart Association (AHA)

I decided to dig a bit deeper. When did they come to this conclusion?

Here is a chart from the AHA as it was in May 2010:

Compare this to the same chart on the same site in April 2022, shown earlier.

It appears some things have changed! Basically they've decided to crank up the alarm level on most of the numbers. You can observe the differences yourself; Stage 2 hypertension is a good example. In 2010 you had it if your numbers were more than 160/100, while now it's 140/90. In 2010, if your pressure was below 140, you didn't "have" hypertension -- just "prehypertension." Now, stage 1 hypertension starts at 130.

I did some research. The change happened in 2017. Here is the AHA's news release on the subject:

High blood pressure should be treated earlier with lifestyle changes and in some patients with medication – at 130/80 mm Hg rather than 140/90 – according to the first comprehensive new high blood pressure guidelines in more than a decade. The guidelines are being published by the American Heart Association (AHA) and the American College of Cardiology (ACC) for detection, prevention, management and treatment of high blood pressure.

The guidelines were presented today at the Association’s 2017 Scientific Sessions conference in Anaheim, the premier global cardiovascular science meeting for the exchange of the latest advances in cardiovascular science for researchers and clinicians.

Rather than 1 in 3 U.S. adults having high blood pressure (32 percent) with the previous definition, the new guidelines will result in nearly half of the U.S. adult population (46 percent) having high blood pressure, or hypertension.

A whole lot more people have high blood pressure! I sure hope they did their homework on this. Reading on we find:

The new guidelines were developed by the American Heart Association, American College of Cardiology and nine other health professional organizations. They were written by a panel of 21 scientists and health experts who reviewed more than 900 published studies. The guidelines underwent a careful systematic review and approval process.

OK, it looks like a whole team of experts was in on this one. 

Harvard Medical School

Better check with the people who train the best doctors. Let's make sure this is really up to date.

Here's what they have to say:

Arteries that are tensed, constricted, or rigid offer more resistance. This shows up as higher blood pressure, and it makes the heart work harder. This extra work can weaken the heart muscle over time. It can damage other organs, like the kidneys and the eyes. And the relentless pounding of blood against the walls of arteries causes them to become hard and narrow, potentially setting the stage for a heart attack or stroke.

Most people with high blood pressure (known medically as hypertension) don't know they have it. Hypertension has no symptoms or warning signs. Yet it can be so dangerous to your health and well-being that it has earned the nickname "the silent killer." When high blood pressure is accompanied by high cholesterol and blood sugar levels, the damage to the arteries, kidneys, and heart accelerates exponentially.

Sounds scary. Can I do anything about it?

High blood pressure is preventable. Daily exercise, following a healthy diet, limiting your intake of alcohol and salt, reducing stress, and not smoking are keys to keeping blood pressure under control. When it creeps into the unhealthy range, lifestyle changes and medications can bring it down.

They agree. There are pills I can take.

Department of Health and Human Services (HHS)

Let's make sure the government is on board. After some looking it was very clear that HHS is in favor of keeping blood pressure under control. Finding out exactly what they think and what they're doing proved to be a bit of a challenge. Here's some of the things I learned our government is doing to help us:

• They have published standards and require reports requiring health providers to specify the frequency of visits and other things they are performing with their patient population to control blood pressure.
• They sponsored the Million Hearts Risk Check Challenge, asking developers to create a new consumer app that informs consumers of their general heart risk, motivates them to obtain a more accurate risk assessment by entering their blood pressure and cholesterol values, and directs them to nearby community pharmacies (and other locations) offering affordable and convenient blood pressure and cholesterol screenings.
  
• The Surgeon General issued a Call for Action to Control Hypertension. It's a major document issued in 2020. Sadly, the link to the document was broken, so I wasn't able to read this important initiative. But here's a helpful diagram about it:

The fact that the document was issued is impressive. The section introducing it has a stirring ending: "We must act to preserve the nation’s cardiovascular health now and into the future. Together, we’ve got this!"

Conclusion

Governments and the big authorities in the field are united in the effort to keep us all more healthy by encouraging us all to address the "silent killer" of hypertension. They want us to address it first of all by lifestyle changes, but if that fails, medication is available to keep things under control. Even if we have to take a couple pills a day for the rest of our lives, that's a small price to pay for having a longer, healthier life.

 

This is an issue that similar in many ways to the goal of maintaining a heart-healthy diet that minimizes saturated fat in meat and dairy products, and to combating LDL, the "bad" cholesterol in our blood; they all contribute in their own ways to keeping us healthy.

 

We should all have our blood pressure checked and do what we have to do to keep it under control. If, that is, we want to live a long, heart-healthy life. Naturally there are contrasting views on this seemingly settled topic, for example here.

 

Most of us have heard about high blood pressure. It's one of those conditions that afflict a large number of people. Nearly half of American adults are said by the AHA to have it! You may be able to control it by maintaining a healthy lifestyle, things like avoid eating saturated fats, salt and alcohol, keeping your weight down and getting exercise. Fortunately, there are drugs that can help keep it under control.

Why should anyone care? Strokes! Heart attacks! Premature death!

Is this one of those things that floats in the air but isn't real? Let's take a look at what people who know what they're doing say about it.

The American Heart Association (AHA)

Blood pressure is all about the heart, right? So let's start with the medical association that's all about keeping our hearts healthy. They make it very clear why we should care:

Those folks at the AHA may be doctors who can't write legible prescriptions, but they were sure able to rope someone into producing a scary diagram! OK, you've got my attention. Here's the facts with blood pressure:

What can I do?? What if I maintain a good weight, eat a heart-healthy diet, cut back on salt and the rest and my BP is still scary? There are medications.

How long will you have to take your medication? Perhaps for the rest of your life.

OK, then. If that's what has to be done to avoid the things in the scary diagram above, then so be it.

More American Heart Association (AHA)

I decided to dig a bit deeper. When did they come to this conclusion?

Here is a chart from the AHA as it was in May 2010:

Compare this to the same chart on the same site in April 2022, shown earlier.

It appears some things have changed! Basically they've decided to crank up the alarm level on most of the numbers. You can observe the differences yourself; Stage 2 hypertension is a good example. In 2010 you had it if your numbers were more than 160/100, while now it's 140/90. In 2010, if your pressure was below 140, you didn't "have" hypertension -- just "prehypertension." Now, stage 1 hypertension starts at 130.

I did some research. The change happened in 2017. Here is the AHA's news release on the subject:

High blood pressure should be treated earlier with lifestyle changes and in some patients with medication – at 130/80 mm Hg rather than 140/90 – according to the first comprehensive new high blood pressure guidelines in more than a decade. The guidelines are being published by the American Heart Association (AHA) and the American College of Cardiology (ACC) for detection, prevention, management and treatment of high blood pressure.

The guidelines were presented today at the Association’s 2017 Scientific Sessions conference in Anaheim, the premier global cardiovascular science meeting for the exchange of the latest advances in cardiovascular science for researchers and clinicians.

Rather than 1 in 3 U.S. adults having high blood pressure (32 percent) with the previous definition, the new guidelines will result in nearly half of the U.S. adult population (46 percent) having high blood pressure, or hypertension.

A whole lot more people have high blood pressure! I sure hope they did their homework on this. Reading on we find:

The new guidelines were developed by the American Heart Association, American College of Cardiology and nine other health professional organizations. They were written by a panel of 21 scientists and health experts who reviewed more than 900 published studies. The guidelines underwent a careful systematic review and approval process.

OK, it looks like a whole team of experts was in on this one. 

Harvard Medical School

Better check with the people who train the best doctors. Let's make sure this is really up to date.

Here's what they have to say:

Arteries that are tensed, constricted, or rigid offer more resistance. This shows up as higher blood pressure, and it makes the heart work harder. This extra work can weaken the heart muscle over time. It can damage other organs, like the kidneys and the eyes. And the relentless pounding of blood against the walls of arteries causes them to become hard and narrow, potentially setting the stage for a heart attack or stroke.

Most people with high blood pressure (known medically as hypertension) don't know they have it. Hypertension has no symptoms or warning signs. Yet it can be so dangerous to your health and well-being that it has earned the nickname "the silent killer." When high blood pressure is accompanied by high cholesterol and blood sugar levels, the damage to the arteries, kidneys, and heart accelerates exponentially.

Sounds scary. Can I do anything about it?

High blood pressure is preventable. Daily exercise, following a healthy diet, limiting your intake of alcohol and salt, reducing stress, and not smoking are keys to keeping blood pressure under control. When it creeps into the unhealthy range, lifestyle changes and medications can bring it down.

They agree. There are pills I can take.

Department of Health and Human Services (HHS)

Let's make sure the government is on board. After some looking it was very clear that HHS is in favor of keeping blood pressure under control. Finding out exactly what they think and what they're doing proved to be a bit of a challenge. Here's some of the things I learned our government is doing to help us:

• They have published standards and require reports requiring health providers to specify the frequency of visits and other things they are performing with their patient population to control blood pressure.
• They sponsored the Million Hearts Risk Check Challenge, asking developers to create a new consumer app that informs consumers of their general heart risk, motivates them to obtain a more accurate risk assessment by entering their blood pressure and cholesterol values, and directs them to nearby community pharmacies (and other locations) offering affordable and convenient blood pressure and cholesterol screenings.
  
• The Surgeon General issued a Call for Action to Control Hypertension. It's a major document issued in 2020. Sadly, the link to the document was broken, so I wasn't able to read this important initiative. But here's a helpful diagram about it:

The fact that the document was issued is impressive. The section introducing it has a stirring ending: "We must act to preserve the nation’s cardiovascular health now and into the future. Together, we’ve got this!"

Conclusion

Governments and the big authorities in the field are united in the effort to keep us all more healthy by encouraging us all to address the "silent killer" of hypertension. They want us to address it first of all by lifestyle changes, but if that fails, medication is available to keep things under control. Even if we have to take a couple pills a day for the rest of our lives, that's a small price to pay for having a longer, healthier life.

 

This is an issue that similar in many ways to the goal of maintaining a heart-healthy diet that minimizes saturated fat in meat and dairy products, and to combating LDL, the "bad" cholesterol in our blood; they all contribute in their own ways to keeping us healthy.

 

We should all have our blood pressure checked and do what we have to do to keep it under control. If, that is, we want to live a long, heart-healthy life. Naturally there are contrasting views on this seemingly settled topic, for example here.

 

The forbidden question: What caused the obesity epidemic?

There is an obesity problem. Everyone knows it. Public health authorities proclaim it. Over half the population in the US is now obese. The consequences of being obese in terms of health are serious. Solutions are proposed, but they don’t seem to work. The question that’s almost never asked, the answer to which would help us understand AND FIX the problem, is pure common sense: what started the epidemic? What changed to cause the steady rise of overweight and obese people?

The reason no one wants to ask the question is because the most probable answer is something our major institutions, Experts and Authorities don’t want us to know: Their nutrition recommendations, widely promoted and visible on most food labels that you buy, are based on bad, corrupted science.

We now know how and why the science was wrong. After much study and careful trials, we know what's right. But because of the refusal of the authorities to admit and correct their error, millions of people continue to suffer and die of diseases they would not have if our Medical Health Elites would suck it up, admit error, and fix it.

There is an epidemic of obesity

The epidemic. Well known, accepted. Here's the FDA:

Here's the CDC:

Obesity is a serious chronic disease, and the prevalence of obesity continues to increase in the United States. Obesity is common, serious, and costly. This epidemic is putting a strain on American families, affecting overall health, health care costs, productivity, and military readiness.

Is it under control? The CDC again:

From 1999 –2000 through 2017 –2018, US obesity prevalence increased from 30.5% to 42.4%. During the same time, the prevalence of severe obesity increased from 4.7% to 9.2%.

What's bad about being obese?

According to the CDC, here are some of the consequences of being obese:

What are the medical costs resulting from obesity?

A highly detailed study was published in 2021 going into depth to determine the direct medical costs of obesity.

RESULTS: Adults with obesity in the United States compared with those with normal weight experienced higher annual medical care costs by $2,505 or 100%, with costs increasing significantly with class of obesity, from 68.4% for class 1 to 233.6% for class 3. The effects of obesity raised costs in every category of care: inpatient, outpatient, and prescription drugs. ...  In 2016, the aggregate medical cost due to obesity among adults in the United States was $260.6 billion.

In other words, obese people have more than double the medical care costs compared to those who are not obese. More important, the obese people themselves suffer the poor health resulting from their condition!

How are we told to prevent and/or fix it?

From the CDC:

Obesity is a complex health issue resulting from a combination of causes and individual factors such as behavior and genetics.

Healthy behaviors include regular physical activity and healthy eating. Balancing the number of calories consumed from foods and beverages with the number of calories the body uses for activity plays a role in preventing excess weight gain.

A healthy diet pattern follows the Dietary Guidelines for Americans which emphasizes eating whole grains, fruits, vegetables, lean protein, low-fat and fat-free dairy products, and drinking water.

In other words, exercise more, eat less, and follow the official diet guidelines which emphasize avoiding fat in meat and dairy.

The origins of the obesity epidemic

Did the obesity epidemic appear out of nowhere, for no reason? Nope. The key to understanding and responding to any epidemic is to trace its origins to the time and place of its start. Only then can you understand the problem and often get good ideas about how to mitigate the epidemic and prevent similar ones from getting started.

Look at this chart from the CDC:

A sharp upwards turn in Obesity and Severe Obesity took place in 1976-1980 and has continued rising. From the tables in the document from which this chart was taken, Obesity was about 14% and has risen to 43%, while Severe Obesity was about 1% and has risen to over 9%. That's about 3X and 9X increases. Total Obesity is now over 50% of the population! During this period the Overweight share has remained about the same (about 32%), which means that a large number of people "graduated" to higher levels of weight, probably many normals becoming Overweight while as many Overweights became Obese.

What happened when the "hockey stick" upwards trend in obesity started? It turns out something big happened, with lots of public attention. According to the government website on the history of nutritional guidelines:

A turning point for nutrition guidance in the U.S. began in the 1970s with the Senate Select Committee on Nutrition and Human Needs....

In 1977, after years of discussion, scientific review, and debate, the U.S. Senate Select Committee on Nutrition and Human Needs, led by Senator George McGovern, released Dietary Goals for the United States. ...

The recommendations included:

Increase the consumption of complex carbohydrates and “naturally occurring” sugars...

Reduce overall fat consumption...

Reduce saturated fat consumption to account for about 10 percent of total energy intake...

The widely publicized recommendations were followed up by the first in the series of official expert-approved documents:

In February 1980, USDA and HHS collaboratively issued Nutrition and Your Health: Dietary Guidelines for Americans,

It's important to note that the focus was NOT on obesity. It was on diet-related health, with a particular focus on heart disease. The consensus of Expert opinion at the time was that eating saturated fat causes heart disease. In an effort to reduce heart disease, the authorities started the drum-beat of "Stay healthy! Eat less saturated Fat!"

Obesity took off when we obeyed the Experts

The new dietary advice was shouted from the hill tops. It was pushed by government agencies. It was endorsed by every major health institution, and pushed by nutritionists and doctors everywhere. It was emblazoned on food packaging by law, each package stating how much of the evil, heart-killing saturated fat was in each serving, and how much of your "daily allowance" it used up.

The food that was offered in grocery stores and restaurants changed to reflect the "scientific" consensus. Bacon was bad. If you had to eat meat (even though you shouldn't), you should eat lean (no fat) meat. All these things are still what we see!

Here is a study based on the US National Health and Nutrition Examination Survey (NHANES) that demonstrates the strong linkage between the diet recommendations and the growth of obesity.

From a valuable study on obesity (behind a paywall):

When we put together the following…

1) Obesity is not a simplistic imbalance of energy in and energy out, but a far more complex matter of how, biochemically, the body can store or utilize fat. Carbohydrate is the best macronutrient to facilitate fat storage and prevent fat utilization.

2) Fat/protein calories have jobs to do within the body – they can be used for basal metabolic repair and maintenance. Carbohydrate is for energy alone; it needs to be burned as fuel or it will be stored as fat.

… carbohydrates can be seen as uniquely suited to weight gain and uniquely unsuited to weight loss. The macronutrient that we have been advising people to eat more of is the very macronutrient that enables fat to be stored and disables fat from being utilized.

Increasingly people ate what they were told to eat. Young people grew up eating in the new style, with vastly more packaged foods, sugar and carbohydrates than earlier generations. No surprise, they got fat early in life, and stayed fat.

Marty Makary MD, surgeon and Professor at Johns Hopkins,
treats this from a different angle in his recent book.

Dr. Dariush Mozaffarian, dean of Tufts University’s Friedman School of Nutrition—the nation’s leading nutrition school ... recently wrote in the Journal of the American Medical Association, “We really need to sing it from the rooftops that the low-fat diet concept is dead, there are no health benefits to it.” As a gastrointestinal surgeon and advocate for healthful foods, I’m well aware how this low-fat teaching is based on the medical establishment’s embarrassing, outdated theory that saturated fat causes heart disease. A landmark 2016 article in the Journal of the American Medical Association found that the true science was actually being suppressed by the food industry. Highly respected medical experts like my former Johns Hopkins colleague Dr. Peter Attia are now correcting the medical establishment’s sloppy teachings. He and many other lipidologists know that the low-fat bandwagon has damaged public health. It was driven by an unscientific agenda advanced by the American Heart Association and the food industry, which sponsored the misleading food pyramid. These establishment forces spent decades promoting addictive, high-carbohydrate processed foods because the low-fat foods they endorsed require more carbohydrates to retain flavor. That 40-year trend perfectly parallels our obesity epidemic. Medical leaders like Dr. Attia have been trying to turn this aircraft carrier around, but it’s been a challenge. Despite the science, the dogma remains pervasive. In hospitals today, the first thing we do to patients when they come out of surgery, exhausted and bleary-eyed, is to hand them a can of high-sugar soda. Menus given to hospitalized patients promote low-fat options with a heart next to those menu items. And when physicians order food for patients in electronic health records, there’s a checkbox for us to order the “cardiac diet,” which hospitals define as a low-fat diet. Despite science showing that natural fats pose no increased risk of heart disease and that excess sugar is the real dietary threat to health, my hospital still hands every patient a pamphlet recommending the “low-fat diet” when they’re discharged from the cardiac surgery unit, just as we have been doing for nearly a half century. But nowhere is that now debunked low-fat recommendation propagated as much as in wellness programs.

For more study

The experts are clear on this subject. You already know this, but here are highlights of their views on fat and on cholesterol. Here is background on how saturated and cholesterol became menaces. Here is why you should eat lots of saturated fat and why should not take drugs to lower your cholesterol.

With the billion-dollar-revenue American Heart Association continuing to villanize saturated fat, this insanity is unlikely to stop soon.

Before all this nonsense began...

We had a sensible approach to obesity:

Conclusion

The cause of the obesity epidemic is clear. No one talks about it because the people in charge refuse to admit their role in causing it. As the evidence from RCT's continues to pile up, careful reading shows that the emphatic language about saturated fat has lightened up a bit, but we're not even close to the equivalent of acknowledging, for example, that smoking cigarettes is bad for you. We should be shouting "eat lots of natural saturated fat, the kind in meat, milk, cheese and eggs." We're not there yet. Educated people can nonetheless make their own decisions and do just that -- and improve their health as a result.

 

The Facts are Clear: Don't Take Cholesterol-lowering Drugs

I have described the background and evidence of the diet-heart fiasco -- the hypothesis-turned-fake-fact that you shouldn't eat saturated fat because it raises your "bad" LDL cholesterol, which causes hearts disease. Not only is it wrong -- eating saturated fat is positively good for you!

This deadly farce has generated a medical effort to lower the cholesterol of patients in order to keep them healthy. There have been over a trillion dollars in sales for cholesterol-lowering statin drugs so far.The entire medical establishment has supported this as a way to prevent heart disease.There's just one little problem, now proved by extensive, objective real-world evidence and biochemical understanding: Cholesterol, including the "bad" LDL, is NOT a cause of heart disease. Even indirectly. Lowering LDL via diet change or statins does NOT prevent heart disease. So don't avoid saturated fats or take statins!

Here's the kicker: higher cholesterol is associated pretty strongly with living longer, particularly in women! And the side effects of the drugs are widespread and serious!

Basic facts

Let's start with a few facts:

• Eating fat will NOT make you fat. Eating sugar will make you fat.
• The human brain is 70% fat.
• 25% of all cholesterol in the body is found in the brain.
• All cells in your body are made of fat and cholesterol.
• LDL is not cholesterol! HDL isn't either! They are proteins that carry cholesterol and fat-soluble vitamins. Lowering it lowers your vitamins.

To get the big picture about the diet-heart hypothesis (the reason why you're supposed to take statins in order to lower your cholesterol in order to prevent heart disease), see this post on the Whole Milk Disaster. For more detail, see the post on why you should eat lots of saturated fat.

To get lots of detail, read this extensive review of Cholesterol Con and this extensive review of The Clot Thickens -- and by all means dive into the books. Here is an excellent summary written by an MD explaining the situation and the alternative thrombogenic hypothesis. Here is a recent paper in a peer-reviewed journal reviewing to what extent blood cholesterol causes heart disease.

The Bogus Hyposthesis

How did thing get started? Stupidity mixed with remarkably bad science. Here is a brief summary of a PhD thesis examination of the build-up to the Cholesterol-is-bad theory:

The cholesterol hypothesis originated in the early years of the twentieth century. While performing autopsies, Russian pathologists noticed build-up in the arteries of deceased people. The build-up contained cholesterol. They hypothesised that the cholesterol had caused the build-up and blocked the artery leading to a sudden death (the term “heart attacks” was not much used before the end of World War II).

An alternative hypothesis would be that cholesterol is a substance made by the body for the repair and health of every cell and thus something else had damaged the artery wall and cholesterol had gone to repair that damage. This is the hypothesis that has the memorable analogy – fire fighters are always found at the scene of a fire. They didn’t cause the fire – they went there to fix it. Ditto with cholesterol. The alternative hypothesis did not occur to the pathologists by all accounts.

The pathologists undertook experiments in rabbits to feed them cholesterol to see if they ‘clogged up’ and sure enough they did. However, rabbits are herbivores and cholesterol is only found in animal foods and thus it’s not surprising that feeding animal foods to natural vegetarians clogged them up. When rabbits were fed purified cholesterol in their normal (plant-based) food, they didn’t clog up. That should have been a red flag to the hypothesis, but it wasn’t.

Then Ancel Keys got involved, and the bad idea became gospel.

Population studies

Before taking drugs like statins to reduce cholesterol, doesn't it make sense to see if people with lower cholesterol lead longer lives? The question has been examined. Short answer: people with higher cholesterol live longer. 

Here is data from a giant WHO database of cholesterol from over 190 countries:

More cholesterol = longer life for men, a strong correlation. Even more so for women, who on average have HIGHER cholesterol than men:

When you dive into specific countries and history, the effect is even more striking. Check out the Japanese paradox

To illustrate the Japanese paradox, he reported that, over the past 50 years, the average cholesterol level has risen in Japan from 3.9 mmol/l to 5.2 mmol/l. Deaths from heart disease have fallen by 60% and rates of stroke have fallen seven-fold in parallel. A 25% rise in cholesterol levels has thus accompanied a six-fold drop in death from CVD (Ref 6).

And the strange things going on in Europe led by those cheese-loving French:

The French paradox is well known – the French have the lowest cardiovascular Disease (CVD) rate in Europe and higher than average cholesterol levels (and the highest saturated fat consumption in Europe, by the way). Russia has over 10 times the French death rate from heart disease, despite having substantially lower cholesterol levels than France. Switzerland has one of the lowest death rates from heart disease in Europe with one of the highest cholesterol levels.

Hard-core RCT's (Randomized Controlled Trials)

RCT's are the gold standard of medical science and much else. You divide a population into a control group for which nothing changes and a test group, which is subjected to the treatment you want to test. It's hard to do this with anything like diet! But it has been done in controlled settings a few times at good scale. The results of the RCT's that have been done did NOT support the fat-cholesterol-heart-disease theory and so were kept hidden. But in a couple cases they've been recovered, studied and published.

A group of highly qualified investigators has uncovered two such studies and published the results in the British Medical Journal in 2016: "Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73)." They summarize the results of their earlier study:

Our recovery and 2013 publication of previously unpublished data from the Sydney Diet Heart Study (SDHS, 1966-73) belatedly showed that replacement of saturated fat with vegetable oil rich in linoleic acid significantly increased the risks of death from coronary heart disease and all causes, despite lowering serum cholesterol.14

Lower cholesterol meant greater risk of death. Clear.

The Minnesota study was pretty unique:

The Minnesota Coronary Experiment (MCE), a randomized controlled trial conducted in 1968-73, was the largest (n=9570) and perhaps the most rigorously executed dietary trial of cholesterol lowering by replacement of saturated fat with vegetable oil rich in linoleic acid. The MCE is the only such randomized controlled trial to complete postmortem assessment of coronary, aortic, and cerebrovascular atherosclerosis grade and infarct status and the only one to test the clinical effects of increasing linoleic acid in large prespecified subgroups of women and older adults.

Moreover, it was sponsored by the most famous proponent of the diet-heart hypothesis: Ancel Keys. So what happened? Here's a brief summary from an article in the Chicago Tribune after the 2016 BMJ study was published:

Second, and perhaps more important, these iconoclastic findings went unpublished until 1989 and then saw the light of day only in an obscure medical journal with few readers. One of the principal investigators told a science journalist that he sat on the results for 16 years and didn't publish because "we were just so disappointed in the way they turned out."

From the BMJ 2016 paper:

The traditional diet heart hypothesis predicts that participants with greater reduction in serum cholesterol would have a lower risk of death (fig 1⇑, line B). MCE participants with greater reduction in serum cholesterol, however, had a higher rather than a lower risk of death.

...

The number, proportion, and probability of death increased as serum cholesterol decreased

Wowza. The "better" (lower) your blood cholesterol levels, the more likely you were to die. In fact, "For each 1% fall in cholesterol there was a 1% increase in the risk of death."

Problems with Statins

Not only do statins not work to lengthen lives, taking them is a bad idea because of their side effects. This is a starting place. For example, check the side effects of a leading statin:

Good effects vs. side effects

We know for a fact that lowering your blood cholesterol is a bad idea. We know the drugs that do it have side effects. It's natural to think that the drugs normally do their thing and in rare cases there are side effects. Often, this is far from the truth. Here are excerpts from an article that explains the basic medical math concept of NNT

Most people have never heard the term NNT, which stands for Number Needed to Treat, or to put it another way, the number of people who need to take a drug for one person to see a noticeable benefit. It's a bit of a counterintuitive concept for people outside medicine, since most people probably assume the NNT for all drugs is 1, right? If I'm getting this drug, it must be because it is going to help me. Well, wrong.

What about the side effects of statins?

Many people who take the drug develop chronic aches and pains. The drug also causes noticeable cognitive impairment in a proportion of those taking it, and some even end up being diagnosed with dementia - how big the risk is unfortunately isn't known, because proper studies haven't been carried out that could answer that question. Additionally, the drug causes blood sugar levels to rise, resulting in type 2 diabetes in around 2% of those taking the drug - it is in fact one of the most common causes of type 2 diabetes.

NNT applied to statins:

Well, if you've already had a heart attack, i.e. you've already been established to be at high risk for heart attacks, then the NNT over five years of treatment is 40. In other words, 39 of 40 people taking a high dose statin for five years after a heart attack won't experience any noticeable benefit. But even if they're not the lucky one in 40 who gets to avoid a heart attack, they'll still have to contend with the side effects.

How many patients are told about NNT? If you haven't had a heart attack, the NNT is vastly greater than 40, and yet statins are prescribed when cholesterol is "too high" no matter what. Many of the side effects happen in 10% of the cases, which is four times greater than the number of people who are "helped." Doctors who do this are indeed members of the "helping profession;" the question is, who exactly are they helping?

Here, here and here are more details about NNT for statin use.

Conclusion

If you value science, you should not worry about lowering your cholesterol. If you value your life and health, you should be happy to have high cholesterol. Likewise, you should avoid taking cholesterol-lowering drugs because in the end they hurt you more than they help you. If you're worried about pharma companies losing profits, it's a much better idea to just send them a monthly check -- forget about their drugs!

 

The Facts are Clear: Eat Lots of Saturated Fat

The experts and authoritative institutions are clear: you should eat a low-fat diet and take drugs to reduce your blood LDL cholesterol to safe levels in order to make your heart healthy.  Here is their advice about saturated fat and about blood cholesterol. The capital-E Experts are wrong. They were wrong from the beginning. There was never any valid evidence in favor their views, in spite of what you might read. The quantitative and biochemical evidence is now overwhelming.  Here is my summary of the situation. In this post I’ll cover more of the evidence.

Origins and growth of the saturated fat – cholesterol – heart hypothesis

How did such a bogus theory get started? An experiment with intriguing results was one start. Here's a summary:

The hypothesis harks back to the early part of the twentieth century, when a Russian researcher named Nikolai Anitschkow fed a cholesterol [animal fat] rich diet to rabbits and found that they developed atherosclerosis (hardening of the arteries, the process which in the long run leads to cardiovascular disease). … Rabbits, being herbivores, normally have very little cholesterol in their diets, while humans, being omnivores, generally consume quite a bit of cholesterol. Regardless, the data was suggestive, and led to the hypothesis being formulated.

A paper titled “How the Ideology of Low Fat Conquered America” was published in the Journal of the History of Medicine and Allied Sciences in 2008. Here is the abstract:

This article examines how faith in science led physicians and patients to embrace the low-fat diet for heart disease prevention and weight loss. Scientific studies dating from the late 1940s showed a correlation between high-fat diets and high-cholesterol levels, suggesting that a low-fat diet might prevent heart disease in high-risk patients. By the 1960s, the low-fat diet began to be touted not just for high-risk heart patients, but as good for the whole nation. After 1980, the low-fat approach became an overarching ideology, promoted by physicians, the federal government, the food industry, and the popular health media. Many Americans subscribed to the ideology of low fat, even though there was no clear evidence that it prevented heart disease or promoted weight loss. Ironically, in the same decades that the low-fat approach assumed ideological status, Americans in the aggregate were getting fatter, leading to what many called an obesity epidemic. Nevertheless, the low-fat ideology had such a hold on Americans that skeptics were dismissed. Only recently has evidence of a paradigm shift begun to surface, first with the challenge of the low-carbohydrate diet and then, with a more moderate approach, reflecting recent scientific knowledge about fats.

The early chapters of The Big Fat Surprise book provide a good summary with details of the rise to dominance of the low-fat & cholesterol-is-bad theory.

Strong Data Showing that Saturated Fat is Good

There were problems with the diet-heart hypothesis from the beginning.

The first chapters of The Big Fat Surprise have summaries of studies that were made on peoples around the world who subsisted almost exclusively by eating animals and/or dairy, all of them strongly preferring fatty organs over lean muscle.

A Harvard-trained anthropologist lived with the Inuit in the Canadian Arctic in 1906, living exactly like his hosts, eating almost exclusively meat and fish. “In 1928, he and a colleague, under the supervision of a highly qualified team of scientists, checked into Bellevue Hospital  … to eat nothing but meat and water for an entire year.” “Half a dozen papers published by the scientific oversight committee that scientists could find nothing wrong with them.”

George Mann, a doctor and professor of biochemistry, took a mobile lab to Kenya with a team from Vanderbilt University in the 1960’s to study the Masai. They ate nothing but animal parts and milk. Their blood pressure and body weight were 50% lower than Americans. Electrocardiograms of 400 men showed no evidence of heart disease, and autopsies of 50 showed only one case of heart disease.

Similar studies and results came from people in northern India living mostly on dairy products, and native Americans in the southwest. There were many such studies, all of them showing that the native peoples, eating mostly saturated fat, were not only heart-healthy, but free of most other modern afflictions such as cancer, diabetes, obesity and the rest.

Of course the question was raised of other factors that might lead to these results. The questions have been answered by intensive studies. For example, some formerly meat-eating Masai moved to the city and lost their health. For example, Inuit who changed their diet to include lots of carbohydrates supplied by government were studied by doctors who determined they lost their health.

From the book:

In 1964, F. W. Lowenstein, a medical officer for the World Health Organization in Geneva, collected every study he could find on men who were virtually free of heart disease, and concluded that their fat consumption varied wildly, from about 7 percent of total calories among Benedictine monks and the Japanese to 65 percent among Somalis. And there was every number in between: Mayans checked in with 26 percent, Filipinos with 14 percent, the Gabonese with 18 percent, and black slaves on the island of St. Kitts with 17 percent. The type of fat also varied dramatically, from cottonseed and sesame oil (vegetable fats) eaten by Buddhist monks to the gallons of milk (all animal fat) drunk by the Masai. Most other groups ate some kind of mixture of vegetable and animal fats. One could only conclude from these findings that any link between dietary fat and heart disease was, at best, weak and unreliable.

One of the foundational studies in the field is the Framingham Heart Study, started in 1948 and still going on.

In 1961, after six years of study, the Framingham investigators announced their first big discovery: that high total cholesterol was a reliable predictor for heart disease.

This cemented things. Anything that raised cholesterol would lead to heart disease. The trouble came thirty years later, after many of the participants in the study had died, which made it possible to see the real relationship between cholesterol and mortality due to heart disease. Cholesterol did NOT predict heart disease!

The Framingham data also failed to show that lowering one's cholesterol over time was even remotely helpful. In the thirty-year follow-up report, the authors state, "For each 1% mg/dL drop of cholesterol there was an 11% increase in coronary and total mortality."

Only in 1992 did William P. Castelli, a Framingham study leader, announce, in an editorial in the Archives of Internal Medicine:

In Framingham, Mass, the more saturated fat one ate ... the lower the person's serum cholesterol ... and [they] weighed the least.

Game over! No wonder they've kept it quiet. And not just about heart health -- about weight loss too!

Here is an excellent article with references to and quotes from many journals. Here is the introduction:

Many large, government-funded RCTs (randomized, controlled clinical trials, which are considered the ‘gold-standard’ of science) were conducted all over the world in the 1960s and 70s in order to test the diet-heart hypothesis. Some 75,000 people were tested, in trials that on the whole followed subjects long enough to obtain “hard endpoints,” which are considered more definitive than LDL-C, HDL-C, etc. However, the results of these trials did not support the hypothesis, and consequently, they were largely ignored or dismissed for decades—until scientists began rediscovering them in the late 2000s. The first comprehensive review of these trials was published in 2010 and since then, there have been nearly 20 such review papers, by separate teams of scientists all over the world.

Far from believing that saturated fat causes heart disease, we can be quite certain that it's positively healthy on multiple dimensions to eat it -- it's people who don't eat enough saturated fat who end up overweight and sickly!

Sadly, there are still Pompous Authorities who assure us with fancy-sounding studies that we really should avoid eating fat. This study from 2021 dives into just such a fake study -- a RCT (random controlled trial) study -- that purported to show that eating fat remains a bad idea. Wrong. Here's the summary:

Hiding unhealthy heart outcomes in a low-fat diet trial: the Women’s Health Initiative Randomized Controlled Dietary Modification Trial finds that postmenopausal women with established coronary heart disease were at increased risk of an adverse outcome if they consumed a low-fat ‘heart-healthy’ diet.

These books by Dr. Malcolm Kendrick dive in more deeply and are moreover a pleasure to read. Among other things, The Clot Thickens explains the underlying mechanisms of arteriosclerosis (blood clots, heart disease) and what actually causes them.

Here are several articles with evidence from many scientists on the subject of saturated fat.

Latest Results

The evidence continues to pour out -- not that the vast majority of "professionals" change their tune about what constitutes a healthy diet. Here is a new paper published by Oxford written by cardiologists.

The authors asked exactly the right question:

Cardiovascular disease (CVD) is the leading global cause of death. For decades, the conventional wisdom has been that the consumption of saturated fat (SFA) undermines cardiovascular health, clogs the arteries, increases risk of CVD and leads to heart attacks. It is timely to investigate whether this claim holds up to scientific scrutiny.

They found and went through more than ten years of recent published studies, p through 2021. Here is their conclusion:

Findings from the studies reviewed in this paper indicate that the consumption of SFA is not significantly associated with CVD risk, events or mortality. Based on the scientific evidence, there is no scientific ground to demonize SFA as a cause of CVD. SFA naturally occurring in nutrient-dense foods can be safely included in the diet.

Here is a summary in a journal of the history and latest research on the subject, focused on the national nutrition guidelines, which maddeningly fail to reflect the facts about this subject.

What more needs to be said?

 Conclusion

This is an incredibly important issue regarding the health of people. It's also an in-progress example of the difficulty of shifting a paradigm, even when the evidence against the dominant paradigm (avoid eating saturated fat, use drugs to keep your cholesterol low) is overwhelming. Could it be possible that billions of dollars a year of statins and related cholesterol-lowering drug sales has something to do with it? Then again, when was the last time you heard a prestigious Expert or institution say "Sorry, we were wrong, we'll try hard not to blow it again; we won't blame you if you never trust us again."

Barriers to Software Innovation: Radiology 2

Value-creating innovations are rarely the result of a bright new A-HA moment, though an individual may have that experience. A shocking number of innovations are completely predictable, partly because they've already been implemented -- but put back in the vast reservoir of ready-to-use innovations, or implemented in some other domain. This fact is one of the most important patterns of software evolution.

Sometimes the innovation is created, proven and fully deployed in production, like the optimization method Linear Programming, which I describe here. In other cases, like this one, the innovation is built as a functioning prototype with the cooperation of major industry players -- but not deployed.

In a prior post I described how I went to the San Francisco bay area in the summer of 1971 to help a couple of my friends implement a system that would generate a radiology report from a marked-up mark-sense form. We got the system working to the point where it could generate a customizable radiologist's report from one of the form types, the one for the hand. Making it work for all the types of reports would have been easy -- we demonstrated working software, and wrote a comprehensive proposal for building the whole system. It was never built.

True to the nature of software evolution, the idea probably pounded on many doors over the years, always ignored. But about 10 years ago, a pioneering radiologist in Cleveland came up with essentially the same idea. Of course, instead of paper mark-sense forms, the radiologist would click on choices on a screen, and would usually look at the medical image on the computer screen. This enabled the further benefit of reducing the work, and letting doctors easily read images that were taken in various physical locations. Tests showed that doctors using the system were much more productive than those who worked in the traditional way. Finally, they decided that mimicking the radiologist's normal writing style was a negative, and that the field would be improved by having all reports follow a similar format, with content expressed in the same order in the same way. This was actually a detail, because the core semantic observations would be recorded and stored in any case, enabling a leap to a new level of data analytics. It also, by the way, made the report generation system much easier to build than the working prototype we had built decades earlier, which enabled easy customization to mimic each radiologist's style of writing.

The founding radiologist was a doctor, of course, and knew little about software. He did his best to get the software written, got funding, and got the system working. Professional management was hired. My VC group made an investment. Many people saw the potential of the system; it was adopted by a famous hospital system in 2015. But in the end, the company was sold off in pieces.

Nearly 50 years after software was first written that was able to produce medical imaging diagnostic reports quickly and reliably while also populating a coded EMR to enable analytics, the system is sitting in the vast reservoir of un-deployed innovations. It can be built. It saves time. It auto-populates an EMR.

Many people have opined on why this particular venture failed to flourish. It's a classic example of the realities of software innovation and evolution. The reasons for failure were inside the company and outside the company. For the inside reasons, let's just say that the work methods of experienced, professional managers in the software development industry lead to consistently expensive, mediocre results. Nonetheless, the software worked and was in wide production use, delivering the advertised benefits. For the outside reasons, let's say that, well, the conditions weren't quite right just yet for such a transformation of the way doctors work to take place.

The conditions that weren't right just yet for this and uncountable other innovations add up to the walls, high and thick, behind which a reservoir of transformative innovation and "new" software awaits favorable conditions. In other words, the reservoir of innovations wait for that magic combination of software builders who actually know how to build software that works, with a business/social nexus that accepts the innovation instead of the standard no-holds-barred resistance.

Corporations promote what they call innovation. They are busily hiring Chief Innovation Officers, creating innovation incubation centers, hanging posters about the wonders of innovation, etc. etc. They continue to believe the standard-issue garbage that innovation needs to be invented fresh and new.

The reality is that there is a vast reservoir of in-old-vations that are proven and frequently deployed in other domains. All that's needed is to select and implement the best ones. HOWEVER, a Chief Innovation Officer is STILL needed -- to perform the necessary function of identifying and breaking down the human and institutional barriers that have prevented the in-old-vations from being deployed, in many cases preventing roll-out for -- literally! -- decades!!

Barriers to Software Innovation: Radiology 1

There is a general impression that software innovation in one of its many forms e.g. “Digital Transformation” is marching ahead full steam. There are courses, consultants, posters hanging in common spaces and newly-created Chief Innovation Officer positions.  What’s new? What’s the latest in software?

The reality is that there are large reservoirs of proven, tested and working software innovations ready to be rolled out, but these riches are kept behind the solid walls of dams, with armies of alert guardians ready to leap in and patch any holes through which these valuable innovations may start leaking into practice. Almost no one is aware of the treasure-trove of proven innovations kept dammed up from being piped to the many places that could benefit from them; even the guardians are rarely fully conscious of what they’re doing.

If anyone really wanted to know what was coming in software, all they would have to do is find the dams and peer into the waters they hold back.  In spite of the mighty dams, it sometimes happens that the software finds its way into practice, normally in a flood that blankets a small neighborhood. Sometimes the flood has been held back for decades. There are cases I know of where an innovation was proven 50 years ago, and is still not close to being rolled out.

The dams are built in many ways with many materials. The raw materials appear to include aspects of human nature: ignorance, sloth, greed -- you know, the usual. The really high, solid dams have broad institutional support, in which “everyone” is fine with things as they are, and won’t so much as give the time of day to an amazing innovation that would change many things for the better – except of course for a key interest group.

Here is one of the examples I personally know about. It was one of my introductions to what innovation is all about, and the sad fact that creating a valuable innovation is generally the easy part – the hard part is usually overcoming the human and institutional barriers to deploying it.

Automating Medical Image Reading and Reporting

When a radiologist gets an X-ray, there are two phases of work. The first is to “read” the X-ray and observe anything non-typical that it shows, anything from a broken bone to a tumor. The second is to generate a report of the findings. Most radiologists, then and now, dictate their findings; then someone transcribes the dictated report and sends it as needed. The details of the report can vary depending on the purpose of the X-ray and the kind of person for whom it’s intended.

There has been technology first tested decades ago that appears to show that software is capable of “reading” an X-ray at least as accurately as a human radiologist. I will ignore that work for now, and focus on what should be the less threatening technology, which is translating the doctor's observations to an appropriate report.

While I was in college, I worked on the early ARPAnet with an amazing group of people, one of whom was an MIT student from the San Francisco area who later went on to fame making major advances in integrated circuits, among other things. The summer after we did most of our ARPAnet work, he got involved with a new initiative to transform the way radiologist reports of X-rays were created. He knew that some of my skills in automated language parsing and generation were relevant, so he invited me out to pitch in. I went.

GE, then and now, was a major maker of medical imaging systems. They were seriously experimenting with ways of enhancing their systems to make it easier for radiologists to produce reports of their findings. They created a set of mark sense forms, of the kind widely used at the time for recording the answers to tests, to enable a radiologist to quickly mark his observations of the part of the body in question. Here is the form for a person's guts:

Here is part of the form for the hand, showing how you can mark your observations:

Here is part of the form for the spine, showing how you can customize the report output as needed:

My friends had gotten most of the system together -- all I had to do was build the software that would create the radiologist's report. Because of uncertainty about radiologist's accepting the results, I had to make the report generator easily customizable, so that the radiologist's typical style of writing was created.

Leaving out the details, in a few weeks I created a domain-specific language resembling a generative grammar and rules engine to do the job -- along with the necessary interpreter, all written in PDP-8 assembler language, which was new to me. My friends wrote a clear and compelling report describing our work and included an example of our working software in it. Here was the sample filled-out form:

And here was part of the report that was generated by the software we wrote from the input of that form:

The software worked! And yes, the date on the report, 1971, is the date we did the work.

A major company, prominent in the field, had taken the initiative to design mark-sense forms, incorporating input from many radiologists. A few college kids, in contact with one of GE's leading partners, created a working prototype of customization report-generating software, along with a proposal to bring the project to production.

Just as a side effect, this project would have done something transformative: capture the diagnostic observations of radiologists into fully coded semantic form. This is a form of electronic medical record (EMR) that still doesn't exist, even today! For all the billions of dollars that have been spent on EMR's, supposedly to capture the data that wil fuel the insights that will improve medical care, a great deal of essential medical observation is still recorded only in un-coded, narrative form -- including medical imaging reports!

The bottom line is that this project never got off the ground. Not because the software couldn't be written, but because ... well, you tell me.

See the next post for the continuation of this sad but typical story.

Medicine as a Business: Medical Testing 2: Doing the Test

This is the pinnacle post of the series on medical testing, which starts here.

It's the pinnacle because I've finally climbed the mountain of scheduling, and I'm going to the radiation center for my test. Hooray! I'm at the top of the mountain! It will be easy after this, just getting the results and the bill.

I've been to the imaging center before. I'm well aware of their attempts to hide behind misleading signage:

Its nearly-secret location is several floors deep in the basement -- only those who really want to get there, and have the persistence to get there, make it.

I arrive more than the half hour early they requested, to allow plenty of time for the front-office staff to do their work. What's there to do? I've been there before; how can there possibly be anything about me they don't already know?

First of all, it's an iron-clad tradition to give entering patients a clip board full of paper that needs to be filled out, with lots of boxes to check. Have I been through this before? Yes. Every single time I visit. There's a simple explanation for this. Think back to cop shows you've seen where there's a witness or suspect the cops think might be lying or leaving something out. Or where there are two people who they think have concocted a story, and they interview them separately, trying to trip them up. The cop usually starts by saying, "I know you've been through this with my doughnut-eating colleague X, but I need you to take me through it again slowly, step by step." If it works for the cops, it should work even better for the medical staff, right? They carefully check every answer I give and cross-check it with all the previous answers I've given and analyze the differences. This way they can tell when a patient is lying, or when their memory is crashing because of whatever is wrong with them. Or simply to gauge the patient's intelligence and memory, to rank all the patients and do something wonderful with the results that only members of the doctors' cabal know about. AlI I know is that I have to waste time on each visit, only to have the staff glance at the first page, and file it.

I end up waiting for about an hour. Finally someone calls my name, and I follow her out of the waiting room through the trackless maze of hallways. After a bit of walking, I'm introduced to a person who, she tells me, will take my blood for testing.

The pre-MRI blood test

I've been through this before, and nothing bad happened. It just caused, as usual, another delay in starting the MRI, because they wait for the results of the blood test. Which results (of course) no one gives to me, the person blood was tested.

But there are a couple things to note about this practice.

• The main purpose of the test is to see if I'm likely to have an adverse reaction to the extremely safe contrast material that will be injected for some of the images.
  • The main concern is with the few subjects who have abnormal kidney function.
    
  • I had an MRI with contrast just 3 months prior. How likely is it that my renal function went south during the interval?
  • Doing the test for everyone is just not needed. See this, for example.
  • Doing the test for me was a waste of time and money.
  • In any case, it's clear that there are no standards that are followed here!
• Given that you're going to do a test, of course my blood needs to be drawn.
  • My blood was drawn by ... an RN.
    • Registered Nurses are amazing people with years of training, often including an undergraduate degree and more.
  • My blood could just as well have been drawn by a phlebotomist.
    • You can train to become a phlebotomist by having a high school diploma, taking a month-long full time course, and taking a certification test. Boom, you're done.
  • I don't think I need to comment about the different in cost.

After more waiting in a special waiting room, I'm finally called into the MRI room.

The MRI itself

The MRI nurse/technician was courteous and professional, like everyone else I encountered during the testing process. But the process was inexcusably bad, wasting time and money and reducing quality.

First, the nurse asked me where the tumor was that was to be imaged. This could have been good. It's classic checklist, the sort of thing you should do to avoid error. See this for details. Why wasn't it good here? She wasn't double-checking to make sure the computer-based instructions were correct -- she was asking to find out!

Imaging studies have been done on me of this area. Multiple times. Including at Mount SInai. Mount Sinai has incredibly detailed information about exactly where the tumor is, more accurate by far than anything I know. Nonetheless, I was the nurse's primary source of information about exactly where the pictures should be taken! She placed pieces of tape on my body indicating the limits, and those pieces of tape were her only source about where to take pictures.

Next, I laid down on the MRI bed. The nurse had me slide my shoulder into a little compartment, something which had never happened on any prior MRI. Clearly the dial on my paranoia control was set way too low, because I just vaguely thought, hmm, this is different, well she must know what she's doing. After adjusting me a couple times, I got to enjoy the usual loud noises in a confined space during which I was to remain rock-solid motionless; this pleasure went on for 20 minutes or so. Then I got rolled out.

The nurse tells me that the compartment my shoulder is in is a "camera." Unfortunately, the camera wasn't capturing all the area of the tumor, so she would have to use a different camera and do everything again. She gets out a thick, flexible plastic sheet and places it on my shoulder. I recognize it immediately, because it's exactly the same device that has been used on each MRI I've had, regardless of the imaging center that has done the work.

Amazing. Frightening. When I go a hair-cutting place, they record my visit and the choices and selections I made for getting a cut. When I go again, even if it's a different person, they'll ask something like "same as last time?" And then they'll normally do the checklist thing of confirming their understanding of what last time was. The point is: they know what I got last time. They recorded it. A hair-cut place. The only thing I can imagine is that the advanced technologies that hair salons use for keeping information about their customers haven't yet made it to the world of medicine. The plain fact was that Mount Sinai had either not recorded (probable) or not used (possible) key information about the image that was taken and how to take it. I would use the word "inexcusable" for this, but without a few choice 4-letter words, such a word would be far too mild to describe what went on here.

About 3 hours after I arrived, the MRI had been taken and I was free to go.

The MRI technology and equipment

This isn't part of my test specifically, but it's on my mind every time I encounter medical equipment. I'm a computer guy since forever (see this for details of my background), and I know too much about the technologies and the companies that are used in this equipment, and the hardware and software processes that create it.

The highly regulated companies using highly regulated processes to build this hardware and software are unique in technology. The regulation is supposed to protect the public and assure high quality. In fact what it does is assure that only a couple companies can supply the equipment in a government-protected monopoly, at absurdly high cost.

The net result of this is that specialized equipment and software are built to meet the regulations, even when COTS (commercial off-the-shelf) equipment is widely available to do the job with high quality and great performance at a fraction of the price. A prime example of this is the PACS (Picture Archiving and Control System) that all medical imaging systems include. This is basically a standard file storage system with a database that logs everything put in and enables access to images.

At the heart of the MRI is a body of software that could be built, maintained and enhanced at a tiny fraction of today's cost -- a 10X improvement is the minimum one could expect under a rational set of rules. Here is a detailed post with examples of the insanity and, just as important, a specific proposal for how to fix it.

Conclusion

I got the MRI. Nothing awful happened to me. I'm grateful that medical science/engineering has gotten to the point that something as truly amazing as an MRI is even possible. I can certainly imagine things being much worse than they were.

That being said, the opportunities for improvement on multiple fronts are HUGE. The patient's time and inconvenience could be greatly improved. The operational cost of performing the MRI could be considerably reduced, and the quality and consistency improved. Finally, the capital cost and rate of innovation of imaging machines in general could be HUGELY enhanced by drastic changes to the regulations controlling the design and manufacturing of the devices.

Even more good news: my saga was not yet over. I don't have the results yet! Wait until you read about what I went through to get them...

Getting Results from ML and AI 4: Healthcare Examples

While the success patterns laid out in the prior posts in this series may seem clear in the abstract, applying them in practice can be hard, because nearly everyone who thinks or talks about AI (these sets over overlap very little, sadly) takes a different approach.

http://www.blackliszt.com/2018/03/getting-results-from-ml-and-ai-1.html

http://www.blackliszt.com/2018/04/getting-results-from-ml-and-ai-2.html

http://www.blackliszt.com/2018/04/getting-results-from-ml-and-ai-3-closed-loop.html

So here are a couple examples in healthcare to illustrate the principles.

The spectrum of problems

One useful way of understanding the winning patterns in AI is to understand the range of problems to which it may be applied. It's not difficult to arrange the problems as a spectrum. While there are many ways to characterize the spectrum -- here's a prior attempt of mine to characterize the spectrum in healthcare -- perhaps it's easiest to understand it in terms of the typical salary of the person whose work is being replaced or augmented by the AI technology.

At one end of the spectrum are low-paid people performing relatively mundane, repetitive tasks. These people have relatively little education and minimal certifications compared to those higher on the spectrum. Think back-office clerical staff.

At the other end of the spectrum are highly paid, educated and certified people performing what are understood to be highly skilled and consequential tasks. Think doctors.

The very name "artificial intelligence" tells you at which end of the spectrum AI is normally applied. The popular image, supported by the marketing of the relevant vendors, is that AI is amazingly smart, smarter than the smartest person in the room, just like the way that IBM's Deep Blue (predecessor of Watson) beat the human world champion playing "Jeopardy," and beat the then-reigning world champion playing chess.

To put it plainly, while these achievements of Deep Blue were amazing, they were victories playing games. They were not victories "playing" in the real world. Games are 100% artificial. The data is 100% clear and unambiguous. There are no giant seas of uncertainty, ignorance or unknowability -- unlike the real world, which is chock full of them. Nonetheless, IBM and whole piles of people who self-identify as being "smart," and are widely perceived as being smart, jumped on the "AI does what smart people do" bandwagon.

This was and is incredibly stupid and 100% bone-headed wrong. Not only is it bone-headed in terms of intelligent application of AI, it violates simple common sense. If you knew a talented high school kid who played a mean game of chess, would you drop them into a hospital and give them a white coat? Even after the kid claimed to have read and understood all the medical literature?

The smart thing to do is to apply AI to tasks that are relatively simple for humans, at the "low" end of the spectrum, and see if you can get a win. If you can make it work, by all means graduate to the next more complicated thing. It turns out that replacing/augmenting human tasks that are mundane, "simple" and repetitive is amazingly challenging! Yes, even for super-advanced AI!

IBM Watson in healthcare

I know I've made some strong statements here. It's little old me vs. a multi-billion dollar effort by that world-wide leader in AI technology, IBM. Who's going to win that one? Turns out, it's easy. See this, for example.

IBM claims to get many billions of dollars in revenue from Watson. But everything about getting it to do what doctors can do has proven to be vastly more challenging than anyone thought, and its advice rarely makes any difference, even when it's not wrong. And this, after years of work by top doctors at top institutions doing their best to help IBM "train" it!

Here is a summary of the situation:

Let's note: the Watson effort is built on the most famous "smart computer" technology ever, funded to the tune of billions of dollars, with technology acquisitions and expert help from all corners. The "disappointing" outcomes are not the result of having picked the wrong algorithm or something easily fixed. The failures are a direct result of not following the success patterns described in the earlier posts of this series, combined with applying AI to the wrong end of the job-complexity spectrum described earlier in this post.

Olive in healthcare

If IBM can't manage to pull off a win in healthcare, after years of applying the most advanced AI and spending billions of dollars with the best help that money can buy, I guess it's impossible, right?

Wrong. IBM made a fatal strategic mistake. They used AI to attack the hardest problem of all, at the wrong end of the complexity spectrum. Has anyone done this the right way? Applied modern AI and related automation technology to the right end of the complexity spectrum? Yes! Olive has!

Olive is making a positive difference today (please note the use of the present tense here) in many hospital systems by reducing costs, reducing error rates and getting patient information where it needs to go more quickly and efficiently, saving time and aggravation of medical workers along the way. The money and time it saves in the back office may not seem glamorous or "leading edge," but every minute and dollar it saves is time and money that can go to making patients healthier, instead of disappearing down the "overhead" sink-hole.

Getting a pre-auth for a key procedure so it can be performed. Submitting all the right information so a claim can be paid. Getting information to pharmacies so patients can get the life-saving drugs they need. Getting all the information from incompatible, hard-to-navigate EMR's so doctors have all the information they need to give patients the most appropriate care. These absolutely essential tasks are largely performed in windowless rooms far removed from patient settings by people who work hard at largely thankless jobs that aren't well-paid -- but are absolutely essential to providing care to patients. And they're harder than they look! Anyone who's spend any time with a modern EMR can't help but think of the endless meetings attended by skilled professionals at the software vendor trying to find yet new ways to confuse and confound the users. And anyone who has dealt with getting insurance companies the information they demand can't help but think of a cranky three-year-old who lost emotional maturity when he grew up. Bottom line: this stuff is hard!

Olive gets it done, using an exotic collection of works-today technology, silently learning from the people who do the work today. And gets it done without having to upgrade or replace existing computer systems. Amazing.

The founders at Olive are doing AI the right way, attacking the right end of the complexity spectrum. They follow most of the rest of the success patterns laid out in the prior posts of this series, above all attention to data and detail, working from the bottom up in terms of algorithmic complexity, and using closed loop. It's a hard problem, and it was hard work to get it done. But they did it, without the massive armada IBM fruitlessly assembled.

Disclosure: Olive is an investment of Oak HC/FT, the venture firm at which I'm tech partner.

 

Who Owns your Health Data?

You own all the data about yourself, right? It's your blood pressure, your date of birth and your test results, after all.

Forget about owning your data -- just try to get your hands on it! You may think you own it, but the sad fact is that you don't possess it! (Remembering hearing about how possession is nine tenths of the law? It applies here in spades.)

Health systems like to appear to be great folks who really care about you. These days, they all talk about how great their patient information portal (or whatever) is. Hah. Just try to use it!

I've talked about how essential it is to have a personal EMR. I've sarcastically described a big break-through in EMR interchange with details from a personal example. And most recently why portability is essential for the EMR.

I've just had another MRI and want to get my hands on it, so I can see the details. So I went to the hospital system website, and found right on the first page that they offer a patient portal that lets you get your information. Great! Here's what they say:

I took the next step and immediately ran into a bit of a problem:

Hmmm. I wonder which of these my doctor uses? And which one the MRI will be under?

After lots more work, I finally got to the right portal that had my stuff. I dove right in. I found my list of test results:

Hmmm, something is wrong here. There's got to be more than that! And what's that second item, the path report?

The path report, somehow dated both 11/23/2016 and 1/06/2017 is actually a copy of a report that was done at my first hospital, Mount Sinai, shortly after the biopsy procedure on Feb 21, 2014:

Bad data!

The first item is the most recent MRI I had done at Northwell. When you read the report:

You find that Northwell has a prior MRI they did dated 9/14/2016, and two earlier "outside examinations" dated 9/24/15 and 1/22/2015, in other words, MRI's done at some other hospital they choose not to name. But they had those MRI's in their system! They just chose not to show them to me.

Even worse, they admit that they performed a prior MRI themselves on 9/14/2016, and somehow it isn't made available to me, though it was in the system and available to the person who wrote this report less than a month ago.

They've thrown away or (more likely) withheld from me, either maliciously or incompetently or some combination, a report they did and two reports sent to them by Mount Sinai, helped in part by the miraculous digital system I described here.

Well, at least I should be able to go to the Mount Sinai portal and get the two missing MRI's, right? Let's see. Here is the top of the Mount Sinai patient portal test results page:

Score: one out of two. The MRI from 1/22/2015 is available, but Mount Sinai has decided I don't deserve to have the latest one, 9/24/2015. The reason is clear. That is the very MRI that was transferred to Northwell by the amazing digital process I described. When I removed the MRI from Mount Sinai on the DVD, I guess it was no longer there, right? That's how computer data works, right, when you take it from someplace it's no longer in the original place? How can it be???

Just in case, I decided to put in a request to the portal to supply the missing information. I was constructive, polite and provided the facts. Here was the cheerful, non-helpful response:

In other words, not my problem. As though the providers had anything to do with what information in the EMR makes it into the patient portal.

The only possible explanation for all this madness is that the hospitals involved are using some cheap new software written by a bunch of hacks. They can't possibly be using any of the most famous, widely used, expensive enterprise software systems, can they?

Let's see. Here's what you see at Northwell:

And here's what you see at Mount Sinai:

Oops. Two of the premier, widely used, non-cheap vendors. Each of whom is committed to modern, state-of-the-art EMR's with rich portals to enable patients to access their own data. Except on days that end in "y." Or when it's too hot or too cold outside. Or something.

Oh, I know! Their backs must be against the wall, humping to get all those wonderful features into their EMR's so that doctors can spend even more time staring at screens instead of being bothered by patient contact. They must be stretched so thin, they just can't afford to get the work done, and all my sarcasm is just nasty and uninformed!

Let's see. Here's AllScripts:

Lack of money is not the issue at Allscripts. Epic is privately held, so there's no way of knowing their profitability, but by every indication, they're doing just fine. 

I guess it all comes down to the simple fact of who owns the data: possession being 9/10's of the law, the fact that they have it means that we patients can have what we fantasize to be our own data when we are able to pry it out of their cold, dead hands.

 

How to Avoid Cutting off Breasts by Mistake

I think we can all agree that if a breast is not diseased, it should not be removed. High on the list of modest, achievable healthcare goals should be avoiding misdiagnosing breast cancer, and avoiding cutting off healthy breasts.

There are widely known methods and proven technologies that are available for achieving this goal. Instead of applying them, the leading minds in the healthcare technology field ignore them, and instead invest billions of dollars in exotic, cool-sounding AI software that may deliver benefits sometime in the future. Something is deeply wrong here.

Yes, breasts are cut off by mistake

Perhaps you think I'm exaggerating? Here is a recent cover from the NY Post:

The woman felt a lump and had a biopsy. The diagnosis was cancer. She was sent to another hospital for surgery.

Makes, sense, right? Someone should double-check. The rule in carpentry is "measure twice, cut once." When breasts are involved? Double-check should be the minimum; triple-check would be nice.

Checklists

Wait, hasn't someone gone into this already? For healthcare, specifically? Oh, yeah, there's that book written by that famous doctor on this very subject, Atul Gawande:

He dives real deep into checklists in many fields, medicine in particular. Here's a partial summary by Malcolm Gladwell he puts on his site:

The hospital at which the healthy breast was removed knew about checking.They wrote a procedure for it!

What was the procedure? More paperwork. Another in the long list of things doctors have to plow through before they can do their jobs. If doctors actually took all the paperwork seriously, they'd get nothing done. In other words, the "procedure" was just paperwork created by lawyers and bureaucrats that makes life harder and helps nothing. As usual.

Effective, automated workflow checklists

What the healthy-breast-removing hospital did was not what Gawande had in mind, of course. He was thinking group meetings at which everyone goes through each step and signs off. Something meaningful. But that doesn't exactly apply here, since the double-check pathology exam should have taken place before surgery was scheduled. Thinking about it, there are many similar situations in which the checklists are spread out.

There's a concept and proven technology that applies here: workflow. Think of a flowchart with worksteps, lines and conditional branches. Here's a trivial example:

Think of the workflow as being driven not by paper diagrams like this, but implemented in software that interacts with EMR's and people, and tells them what to do.

In this case, when the patient was referred for breast surgery, a proper workflow would have scheduled the pathologist to examine the cancer biopsy data before anything else happened. If the results were negative, as they would have been, the patient would have been notified and that would be the end of it. Only if the results were positive would the system allow breast surgery to be scheduled.

Workflow systems assure that all the work that should be done is done. They eliminate paperwork by putting the checking and doctor sign-offs into the system. No lawyers. No bureaucrats. Near-zero errors. Corrections and enhancements can be made to the workflow without massive re-training and human error. Workflow is like a system-wide, automated checklist, with all the checklist benefits and more.

Let's do AI instead!

Workflow software exists. It's implemented in many industries, even sometimes in healthcare. It works. It reduces human labor and improves outcomes. Why isn't it ubiquitous in healthcare?

Workflow works, solves problems and is understandable. AI, by contrast, is cool, the coming thing and few of the people yakking about it understand it. AI is exploding:

I see a recurring pattern here: people jumping on the new trend, the leading edge, the cool new stuff that "everyone says" is the coming thing, that none of them really understands. And ignoring relatively prosaic technology that works and can provide real benefits today.

Conclusion

Cutting off healthy breasts tells us everything we need to know about exotic new AI, which is at the far end of the innovation spectrum I've described for healthcare here, and illustrated here. Workflow is at the simple end of the spectrum: proven, works, understandable and understood, delivers immediate benefits. I guess that's why the leading thinkers ignore it and all the "smart money" avoids it. 

Hospital Computer Disasters and Iatrogenic Disease

I finally figured out why hospital administrators (1) don’t care that their computer systems go down, and (2) refuse to admit that they go down. It’s been driving me nuts. When the systems are down, patient health and lives are put at risk! Why the lack of concern and the secrecy?

The answer is simple: people die in hospitals all the time! And on top of the people who would have died anyway, hospitals kill people all the time! Yes, “kill” – either through negligence (such as failure to sterilize) or positive error (wrong treatment). In fact, medical error is the fourth leading cause of death in the US! And how often do you hear about that?! In that context, a few more people dying because of an unavailable computer system is a drop in the bucket. And refusing to talk about it fits the pattern.

Hospital Computer Failures

Hospitals know they have to have computers. They know computers are complicated and they know software is hard. So nearly all use a couple simple, common-sense strategies:

• Give high salaries to the top IT people to make sure they’re getting the best
• Spend lots of money on computing for the same reason
• Buy only what the best places are buying to reduce risk

Sounds good, right? Sure, if you don’t know the facts. The result of these common strategies is consistent: most hospitals use incredibly expensive, generations-old technology that regularly fails. Comforted by the fact that they’re no worse than most of their peers, the hospital big-wigs nonetheless keep a solid lid on the problems and outages that are so severe, they would cripple any other business.

Here are details about disastrous computer systems decisions in hospitals. Here is the story of my personal encounter with outages and keeping the problems secret. Since hospitals know they can’t count on their computers, in practice they’re all about the paper.

BUT … when real people are dying, the “death” or severe crippling of a piece of electronics is, like, who cares?

Causes of Death: the Public Information

Tracking causes of death makes perfect sense. It’s something we want to know for each person who dies; it’s recorded on the death certificate. Here is the relevant section from my great-grandfather’s death certificate in 1923:

It’s something we want tracked, so we can see trends and know where to put our efforts to reduce the causes of death. Here is recent data from the CDC, the US government agency that is supposed to track these things:

Heart disease and cancer are the biggies, right?

Unfortunately, that’s not the whole picture. Hospital executives and government bureaucrats go to great lengths to make sure we don’t know the full story. People might get upset if they knew how many of them had relatives who died in the hospitals as a direct result of negligence and/or medical error! Important people could conceivably lose their jobs!!

Causes of Death: the Information they try to Hide

Even hospitals that have great doctors and special experts can have horrible levels of medical error. But the ones that are really bad? They’re really, REALLY bad. Here’s an example of a death-trap masquerading as a hospital in Brooklyn:

Unfortunately, it’s not just a couple of bad eggs that are the problem. We know it’s widespread and big, but unfortunately because of all the secrecy, it’s hard to know exactly how bad it is. We know it’s bad enough that the equivalent of a jumbo jet of people die of medical error every day:

This makes medical error the fourth-leading cause of death, shown here in terms of deaths per 100,000 in 2010:

Because the people in charge are so anxious to keep the facts from us, the only thing we can be confident about is that, whatever the reported data on medical errors is, the actual number is far greater.

Then there are preventable deaths. Even when there are strict rules about reporting problems, hospitals break them. Reuters did some investigating in 2016:

Among other things, they discovered that there was a superbug outbreak in a New Mexico nursing home the January 2014 that was supposed to be reported. There was repeated delay and denial. In the end, here’s what happened:

What about the CDC? The agency that publishes the bogus statistics that ignores all the hospital-caused deaths? They don’t seem to care:

Things are getting worse:

A book has just come out by Dr. Robert Pearl, CEO of the Permanente Medical Group, responsible for the health care of 3.8 million Kaiser Permanente members. He states that medical error is directly responsible for more than 200,000 deaths per year, and another 200,000 preventable deaths as a result of substandard care.

The theme is clear: suppress the information and focus elsewhere.

Conclusion

With so much energy going into suppression and denial of hospital-caused deaths of human beings, it’s finally clear to me why hospital administrators, bureaucrats and most of the “big thinkers” in the medical profession can’t give the time of day to concerns about computer systems. First, they use paper anyway. Second, it’s someone else’s problem. Finally, however bad the computer systems are, they don’t hold a candle to the ongoing death-and-destruction horror show of real human beings dying. Human beings who, except for the incompetence and ineptitude of some doctors, hospital staff and administrators, would be alive today.

Use Advanced Software Methods to Speed Drug Discovery

Drug discovery is like the worst imaginable, old-style software development process, guaranteed to take forever, cost endless amounts of money, and far under-achieve its potential. There are methods that the most advanced software people use to build effective software that works in the real world, quickly and inexpensively. These small groups invent all the new things in software, and then get bought by the big companies.

Can these fast, agile, effective methods be applied to invent and test new, life-saving drugs and get them to the patients who are dying without them? Yes. The obstacles are the usual ones: the giant regulatory bureaucracies and the incumbents who would be disrupted. Yes, the very people who claim to keep you healthy and cure your ills are the very ones standing between us and speedy drug discovery.

Drug Discovery and Software

While I'm not an expert in drug discovery, I've learned more than I wish to know about the regulations through the software providers to the industry. And like many other people, I've learned from being a patient with a disease that could be addressed by drugs that I am not allowed to take, because they are deep in the labyrinth of the years-long approval process.

I've explained elsewhere how a revolution in medical device innovation could be enabled by transforming the applicable regulations from complex, old-style software prescriptions to simple, goal-oriented ones.

A similar concept can be applied to the process of drug discovery itself.

Old-style Software is Like the FDA's New Drug Regulations

The classic software development process is a long, expensive agony. It's an agony that sometimes ends in failure, and sometimes ends in disaster. It most resembles carefully constructing Frankenstein's monster. It starts with requirements and goes on to various levels of design, planning and estimation. Finally the build takes place. But wait -- we can't "release" the software until we know that its quality is top-notch. And that it meets all the requirements. It's gotta work! So let's make absolutely sure that it's up to snuff before inflicting it on the innocent users. Here are details.

Yes, those innocent users -- who are, by the way, chomping at the bit to get at the long-awaited new software whose requirements they signed off on years ago, and that they actually need to get their jobs done.

So is software development like drug discovery? Let's see.

• Development that's a long, expensive agony. Check.
• Don't release it until its adequacy is PROVEN. Check.
• People who are just dying to use it. Check.

But here's the difference: for software, usually one company both builds it and decides whether and when to release it. That means the business leaders of the company can balance the tension between adequacy and getting it out there. In the case of drugs, it is adversarial: the FDA declares how each step of drug discovery and testing has to be done, and has armies of people to impose its will on the companies that do the work.

The FDA Nightmare

The FDA nightmare has two main parts.

The first nightmare assures that development and testing is performed in what is claimed to be the "safest" way possible -- it's all about protecting patient health! In fact, this means incredibly slow and incredibly expensive. The overhead is far more burdensome than the work itself, which really tells you something. There is a multi-billion company, Documentum, that got started with and still is the leading provider of software to the pharmaceutical industry for handling the documents required by the FDA. Right away, this expense and overhead burden assures that no group of brilliant people will create a start-up and create a new cure for a disease.

The second nightmare is that the process is incredibly high risk. The FDA can kill your new drug at any time, including near the end, after all the time and money is gone. This again reduces the number of groups performing new drug development to a tiny number of rich, giant, risk-averse corporations.

This is like big-corporate software development -- only far worse.

Wartime Methods for Drug Discovery

I've written a lot about wartime software development. A good way to understand it is to look at bridges in peace and war. In wartime, we build effective bridges while under fire in a tiny fraction of the time needed in peace. And the bridges work.

The methods translate well to software. They are practical. They work. They are in regular use by groups that are driven to innovate and get stuff done. There are details in my book on the subject, with lots of examples and supporting material in my other books.

It's very clear that the methods also apply to the FDA's regulation of software. Here is an example. There is no reason other than the usual obstacles to innovation that the principles couldn't be applied to drug discovery in general.

Wartime Drug Development

What we should try is Wartime Software Development morphed into Wartime Drug Development. Here are the principles:

• Grow the baby.

Instead of going through a whole long process and supposedly coming out with perfection at the end, you start with something that sort of works, try it (on volunteers), see how it goes, make changes and iterate.

• Principles of e-commerce and social media

When you think of buying a product, do you just walk into a store and trust the salesperson? If so, you're probably in your 100's and hope to get a computer someday. Everyone else goes on-line, checks reviews, and above all checks comments from real users. The sheer number of comments tells you how popular something is. Of course, you don't blindly believe everyone, and of course you translate what people say to your own situation. There could be awful risks and side effects, but if it sometimes works and your alternative is misery shortly followed by death, you might decide it's worth the risk.

It's a decision that should be in your hands, informed by full sharing and disclosure, not decided on your behalf by a bunch of bureaucrats sitting in offices.

• Open source and full disclosure.

Of the top million servers on the internet, over 95% run linux, an open source operating system. Linux was created by an interesting nerd, and developed by an evolving band of distributed volunteers. It is superior to any commercial operating system. And operating systems are complex; linux contains more than 12 million lines of code! Why shouldn't we make drug discovery open to a similar process? With open source, everything about a drug and its results so far would be open and available for anyone, including patients, to see. Patients and researchers would all be active participants in the open discussions.

• Continuous release

The most advanced sites first bring up their software in extremely limited, volunteer-only releases. Everything is tracked. If things go well, more people can be invited in. Incredible tracking, lots of feedback, explicit and implicit. As software goes into wider release, a new version of it may be made available to a combination of new and existing users. Its use may be expanded, or it may be withdrawn. The process is continuous and iterative. It's called continuous improvement. We use it in lots of domains, ever since its use was formalized by W Edwards Deming in car manufacturing. It's not exactly weird or marginal. We simply refuse to apply its proven principles to drug discovery.

Conclusion

The FDA says its mission is to keep us safe. The gigantic bureaucratic monolith in practice assures that new drug development is performed by a tiny number of elite corporations at great expense, and rarely. Let's at least try a better way of doing things!

My Cat Taught me about the state of Healthcare Provider Data

My daughter's cat taught me a major lesson about healthcare as I described here. Pretty amazing. But Jack the cat also thought I should learn about the advanced databases that providers and insurers maintain about each other. While not as brilliant as the inter-provider EMR interchange breakthrough I've described, the databases have a similar effect to the brilliant gamification strategies for wellness implemented by leading hospitals, but take a whole different approach. The depth and extent of innovation in this industry never fails to amaze me.

Jack's learning environment

As I described before, the terrified cat was outdoors and I had to pick him up to bring him inside. He was scared, so he scratched and bit me. I saw my doctor and got a mis-prescription for antibiotics. Then I needed an X-ray to see what was going on inside the hand that was painful after weeks. That's the situation.

Jack the cat decided this was an opportunity for me to learn about databases and get some extra exercise, no doubt as penance for failing to pet him well or often enough.

The search for the X-ray provider

First, I got a referral to a provider that was way far away from where I live. How did this happen? The doctor claims she called me to find where I live twice and got no answer. Hmmm. I guess the information was mysteriously missing from my records and no one thought it was important to get it, and I guess the fact that I only got one message, and it had no request for where I live was just ... whatever. So I decided I better get active, rather than waiting another couple of days for a referral.

I went onto the Anthem site -- the provider of my health insurance in spite of their horrible computer security track record. I discovered a provider that is covered by them just a couple blocks from where I live:

That should be an easy walk. After more fumbling with the doctor's office, I finally got them to give me a referral.

Here's the place to which I was referred:

Same place. Good. I called them up, and they said no appointments were required, just show up with the referral. I walked right over, but they weren't in the building directory. Hmmm. I asked the person at the desk, who had clearly seen confused and lost people like me before. She told me they've moved, and gave me the new location. Great!

I went back home, and discovered that someone else at my doctor's office had also given me a referral, only to a place that actually has an X-ray machine. So out I walked again, and got my medicinal dose of radiation.

Anthem didn't know that they'd moved. The people on the phone at the X-ray place had no idea. One person at my doctor's office did know -- but another one didn't. In normal life, companies that acted like these did -- my doctor, the X-ray place and the insurer -- would be out of business. But as we all know, healthcare isn't normal life.

Big Data and Blockchain

What happened with me was no big deal. Business as usual in healthcare, and in this case had no consequences beyond getting me to walk more, which is a good thing whether I decide to do it or I'm tricked into doing it.

But let's consider the consequences of this trivial episode.

Where are the Big Minds, the elite in healthcare, spending their oh-so-valuable time and effort? Lots of things, of course, but two of the big obsessions are Big Data and Blockchain. Each of these, for different reasons, is a holy grail of technology for healthcare, if you pay attention to the talks, conferences, articles and real dollars invested.

Big Data is a focus because the leading thinkers and influential, powerful people are convinced that if all this healthcare data is poured into a giant Hadoop data lake and poured over by ultra-modern machine learning tools, we'll discover important things that will make us all healthier.

We already knew that EMR's are riddled with data problems; now Jack has shed light on problems elsewhere:

• If the data is missing or wrong, no amount of bathing in Data Lakes will cause accurate results to pop out. Bad data in, bad results out.
• If there are protocols that have been proven to be the best for treating patients and doctors simply refuse to follow them, nothing improves.

Blockchain has attracted the attention of leading figures among the healthcare elites because of its awesome promise to solve the problem of data interchange and effortlessly created universal health data -- on which Big Data can proceed to work its magic.

BUT ... if no ones cares or is allowed the time to get the data accurate and complete and the data is no good, spreading it around hardly helps anything.

As usual, all the attention goes to the highly visible frosting on the cake, while the underlying layers of the cake rot from inattention.

The consequences of extraordinary cat knowledge

This valuable knowledge about provider databases and the reliability of doctor decision making came from just a couple days of cat-sitting our daughter's cat. The experience was so rich that we decided to get a cat of our own, Priss:

We eagerly await the medical knowledge that Priss will bring our way!

What can Cats Teach us about Healthcare?

If you had asked me what cats can teach me about healthcare a year ago, I would have answered, probably nothing. Well, live and learn. My daughter's cat has just taught me a couple major lessons about healthcare. Who would have thought cat-sitting could lead to valuable knowledge about how doctors prescribe drugs?

Here's Jack:

Jack is a good cat. He knows how to relax, and is definitely not anxious about things:

Jack is a rescue cat. Something bad involving men wearing boots must have happened to him in his early days, because he gets really scared and is desperate to get away from any man wearing boots.

Jack sets up the learning environment

A few weeks ago we were cat-sitting him. He had been outside for too long; workers came onto our property to work on an extended project. It was getting dark. Jack wasn't responding to the usual "come home" inducements. I spotted him hunched down in a hiding spot intensely watching the workers. I went to him. He was too scared to follow me home, since that would bring him out of his hiding place and closer to the scary men. So I picked him up. He got really scared. He scratched and bit my hand pretty well. I managed to hold onto him and get him into the house. Now that he was safe, he was OK, and I just had to treat my badly hurt and bleeding hand, which I did with a thorough wash and bandaging.

First Lesson: Doctors, prescribing and protocols

By the next day my hand had swollen up pretty badly. I got an appointment with my primary care doctor. I provided all the details. She put in an order for antibiotics in case the swelling and redness continued. It did, and I filled the order. I took it as directed, and after 5 days there was still lots of pain and swelling. So she gave me a different kind of antibiotic, which was supposed to cover the kinds of things the first one doesn't.

After a couple days, things weren't improving by much. Here's my hand at that point -- notice the lack of knuckles showing how swollen it still was:

My daughter, who's an MD, had been following the events and asked to see my medications. She then sent me information that made it clear that my doctor had given me the wrong antibiotic! Just as bad, the doctor had advised a wait and see approach, while the literature clearly shows that the right approach is to give the drug right away. I gave this information to my doctor; the only appropriate reaction would have been embarrassment and apology, and that is not what happened.

Finally, I wondered what if you didn't have an amazing daughter who happened to be an MD with access to the literature? This makes it even worse for my doctor: Dr. Google came up with the right answer -- the answer to the question MY doctor got wrong. And wouldn't admit it.

I've had an incurable form of cancer. As my cancer doctor said, I've won the lottery, and I'm OK for now. That was hard. The cat bite was easy. There's no excuse for failing to learn the right approach if you don't already know it and following the approved protocol. My trust in doctors other than my daughter for doing simple things is now below zero.

Details of the first lesson

The points been made. If you are skeptical or want details, here we go:

First prescription:

Second prescription:

The article on UptoDate (a resource used by doctors to make sure they're up to date) recommending Augmentum (commercial name of a combination of amoxicillin and calvulanate):

The part of the article on prophylaxis:

I gave the information to my doctor. Here is the key part of her response:

In other words, she decided to violate the authoritative protocol because of "anecdotes." Not because there's an emerging body of evidence-based thought. Anecdotes.

Here's what I should have done before accepting her treatment. I should have asked Dr. Google. Here's the question:

The first result is Google's attempt at giving the answer:

Prophylactic Augmentin. How about that? But the article's 10 years old. Let's check the first "regular" result:

Same thing. Respectable source. But undated. Check the next result:

Just two years old, in a real medical journal, same advice. We're done here.

Conclusion

Too many doctors just do the wrong thing. Even when they know it's the wrong thing, they do it anyway! Doctors increasingly complain about having everyone second-guess them and look over their shoulders. Well, guess what: when you screw up, you deserve that and more.

I've long since preferred to get my cash from an ATM rather than a teller. I'm now at the point where, for anything that's at all routine, I will strongly prefer an automated medical knowledge agent to a doctor who can't be bothered to do the right thing. Until that's available, I will just have to endure doctors not liking me because I check each and every thing they do to make sure it's the right thing.

The best thing is -- Jack the cat wasn't done! I'll tell the next important thing he taught me in a post soon to come.

Hospital-based Innovation in Wellness

I was shocked to discover on a recent visit that a giant but innovative local hospital system has implemented a break-through in wellness. They have adapted some of the industry's leading-edge employee wellness techniques and made them work for patients visiting their hospital, thus adding a whole new dimension in the way they make their patients healthy. Much like my previous report of a EMR interchange break-through, it's so radical and unexpected I wouldn't have believed it unless I had experienced it myself.

Employee Wellness

There has been growing recognition that healthy, happy employees are productive and good for business. There has also been growing recognition that being healthy goes way beyond responding effectively when you get sick. People increasingly understand that when you're active, fit, engaged and have good eating habits, you are more likely to be healthy and happy.

There's an amazing Oak HC/FT company that's at the forefront of this movement, Limeade. Here's their summary of what they do:

You can see that they clearly understand the relationship between wellness and health.

Even the picture implies that getting people moving, fit and engaged is a major key to success.

Wellness for patients in the hospital

Hospitals are all about old-style health, i.e., responding effectively when people get sick. But some hospitals are really innovative. I visited one today, and the banner they had proudly hanging in a busy central hallway made their commitment to innovation clear.

I admit I thought their innovations were limited to "just" making sick people better. Hah! They are actually pioneering the application of modern wellness techniques to patients visiting for treatment!

Wellness techniques

I guess it's worth reviewing briefly what some of the most important techniques are. I don't think it's mysterious; most people know what they are:

• Exercise. Without exercise, good things don't happen. You've got to move those muscles!
  
• Heart Rate. Yes, you can lazily move your muscles. But that's not exercise -- you've got to elevate your heart rate, so that key muscle also gets exercise!
• Mental exercise. Particularly as you age, exercising your mind in new ways helps keep you young. But even for young people, learning new things and thinking outside your normal comfort zone can give you a major boost.

Wellness during a hospital visit

It would be one thing for a stodgy old hospital to put up signs that encouraged wellness. No big deal! But that's not what these guys did. The very best techniques are ones that don't feel like a burden. They "trick" you into doing something you might think is fun, and along they way, something good takes place, like wellness in this case. It's called "game-i-fi-cation." And that's exactly what I experienced during the course of a normal, every-day visit for a diagnostic procedure at this amazing hospital.

The game started before I got in the door. I was given the address: right on Fifth Avenue, that can't be too hard. But right away, I couldn't find it! I walked up and down the street, finding addresses that are larger and smaller than the one I had been given, and finally concluded that this numberless entrance was probably the right one.

You might think that this is just someone having trouble finding an address. But it's really the low-key start of the game -- they draw you in slowly. I looked and looked, and there just was no number! In retrospect, the conclusion is obvious: this is the building in which wellness is slyly delivered to improve everyone's health.

I walked in and found myself in a huge open space. Where should I go?

I walked and turned my head as I went and finally noticed the place where it had to be:

This is surely it -- it's clearly labelled cardio-vascular repeatedly, and I was having a heart test. Done. Still clueless about the wellness being delivered to me, I walked in and talked with the nice ladies at the counter. After they determined that I wasn't in the process of dying in front of them, they returned to what they were doing and eventually found out who I was and what I wanted. Oops. I'm in the wrong place. I should return to the giant hall and ask the guard.

Eventually, the helpful guard pointed and gave directions involving walking, turning left and/or right, and going through various doors. Here's the view at this point:

It's a good thing I paid attention, because part of the game is the absence of signs and directions. The theme of finding the right building was intensified once you were inside. And I was beginning to get anxious. While I had left lots of time, this was taking a while, and I didn't want to be late.

I followed the directions carefully and eventually found myself at another counter with friendly people. After identifying myself, I received another set of directions involving things like going straight that way until you get to the grey doors, then go through them and immediately turn right until you get to the end of the hall ... well, leaving out details, I found another counter.

Please pay attention to the pattern here, and notice the clear and obvious relationship to wellness techniques:

• Exercise. Definitely.
• Heart rate. I didn't walk that fast, but those clever people managed to get my heart rate up by inducing anxiety!
• Mental exercise. Definitely. Finding the place was at least as good as a Pokemon search! Not having signs or directions is part of the plan! They're really committed to this wellness thing -- imagine the trouble they took to assure that all the old signs were removed.

Finally I got to what turned out to be the right place:


But needless to say, my adventure wasn't over. What's a visit to a health professional without a good solid dose of papers with minuscule print, the obvious result of welfare work for lawyers and bureaucrats? But I got a break. Whoever designed the system decided that after such a large and unexpected dose of wellness, the patient should be given a light load of paperwork.
It was laughably small.

And to put it in context, dealing with it was a good way to "cool down" after my adventure in exercise, heart rate elevation and mind stretching achieved by next-generation, gamified wellness techniques.

With any luck, other hospitals will copy this amazing innovation. Who knows, maybe some of them already are!

But that's how hospitals are!

Yes, you're right. But it doesn't have to be that way. Retail stores, for example, compete for customers. They compete on multiple dimensions -- product selection, quality and price, but also convenience and overall customer experience. There is no reason why hospitals couldn't pay some moderate amount of attention to the people who are, after all, their paying customers.

Giant, multi-national companies like Ikea, which is many times larger than any hospital, show that it's possible. Ikea puts real effort into creating a good customer experience. Which includes helping customers go where they need to go. They have a mobile app which helps you. They have maps:

And they have signs in the stores, even on the floor and hanging from the ceiling:

Hospitals aren't too big. Their executives are not under-paid. They just have to care.

Investing in Healthcare Innovation

There is a clear spectrum of innovation in healthcare. I've described the spectrum here, ranging from simple, blocking-and-tackling at one end to exotic AI-related things at the other end, with smart, data-driven ventures in the middle. The exotic end of the spectrum gets most of the money and attention, while the simple end is largely ignored. The middle of the spectrum is occupied by smart, data-driven people who see a problem in the way healthcare works today, and build here-and-now solutions to make it better. Even though there are sometimes structural obstacles to overcome, these entrepreneurs find ways to work with the system and overcome the obstacles, because their solutions benefit everyone involved: payers, providers and above all patients.

Oak HC/FT invests in this kind of middle-spectrum venture, ventures that are bold and smart, but also practical with right-now benefits. Here are a couple of examples.

Aspire Health    

Aspire Health uses analytics to identify patients who may be approaching the end of their lives, often as shown by increasingly serious health problems. In the normal course of events, these patients would spend an increasing fraction of their time bouncing from one facility to another, each provider doing his or her best, but each acting in completely isolated silos. With Aspire, the patient has the opportunity to have a dedicated care team that meets with them and their families, understands their situation and their desires, and takes charge of each aspect of their care from that point on, making adjustments as required. The Aspire team is a true, takes-charge primary care team, assuring that your needs are met. Typically, patients spend more time at home and less time in hospitals and ER's. The result is that patients and their families are much happier and less stressed, with a primary care team that takes responsibility and gets things done.

Limeade    

At first glance, Limeade may not seem like a healthcare company. But what else would you call a company that works with a group of employees to encourage them to eat, exercise and generally act in ways that promote health? While many diseases just happen to people regardless of their actions, many others either start or are exacerbated by behaviors. Limeade applies analytics and smart technology to identify, support and promote healthy behavior. Result? Employees that are not only healthier, but happier and more productive. Everyone wins.

 Quartet Health    

Quartet Health applies analytics to identify people who have behavioral problems and significant non-behavioral health problems that could be interacting with each other to make things worse for the patient. They pay special attention to these patients, and apply an evolving set of automated tools and human intervention to understand the interaction among the issues. In particular, they identify particular combinations for which intervention can make things better for the patient, and then guide the concerned parties to take the actions that will lead to a better outcome, involving the patient and care providers as appropriate. Net result: patients get healthier than they otherwise would have been. And by the way, costs are lower.

VillageMD    

When you have a problem, the first person you're supposed to see is your primary care doctor. Founded by visionary, award-winning Dr. Clive Fields, VillageMD has done extensive longitudinal analytics on patient outcomes, and discovered things the primary care physician can do to improve care while reducing costs by an average of over 20%. Having proven the methods in their own practice, VillageMD is now delivering their techniques to other primary care practices in a highly systematic, targeted way. Everyone wins: payers pay less, patients are healthier, and primary care doctors have greater impact and make more money. The VillageMD techniques are evolving and becoming more powerful with additional experience.

Conclusion

Oak HC/FT has invested in excellent companies in healthcare. The four companies briefly described here are particularly good examples companies in the center of the "simple-to-exotic spectrum" that I have described. These companies deliver here-and-now results using advanced but non-exotic technology combined with win-win business models. Companies like this that use "big data" in practical ways are out of fashion in the world of healthcare IT investment for reasons that are a mystery to me. All I can say is that they're all the rage in the world of Oak HC/FT.

 

The Healthcare Innovation Spectrum: From Washing Hands to AI

There's a spectrum of ways to innovate in healthcare. On one end is simple stuff, like making sure things are clean and germ-free. On the other end is exotic stuff, like using AI: Artificial Intelligence and Cognitive Computing. Obvious questions: (1) where is the money going? (2) where is the value? (3) Is the money going where the value is? Simple answer: the "smart" money is going to exotic gee-gaws, ignoring near-term value and patient health.

Where the Money is going

The money is clearly going to exotica. Ignoring for the moment the billions IBM and others are pouring into what they call Cognitive Computing, VC's are investing heavily in healthcare-directed AI. See this:

We're talking serious money here:

While there are loads of conferences, trials, talks and articles talking about the great future here, there is an obvious conclusion to be drawn: while the money is being spent now, the benefits (if any) are in the future.

That's about all you need to say about it.

The middle of the spectrum

While things like AI are clearly at one far end of the spectrum of healthcare innovation, there are intelligent, educated things in the middle of spectrum. Lots of people are pursuing these innovations with great energy. I've discussed an example of one such approach here.

The Oak HC/FT portfolio company VillageMD is another clear example of data-driven innovation in healthcare. No new math or fancy computers are required. "Just" educated, dedicated people looking at the data and making required behavioral changes based on those facts. The founder of VillageMD, Clive Fields, just won a major award for his work, using all-organic and natural intelligence -- no artificial ingredients! Guess what: it's here and now! The outcomes of real patients are being improved as you read this!

The basic end of the spectrum

On the other end of the spectrum from AI, we've got things that shouldn't need "innovation." They should be standard practice. They have huge impact. They are the shocking, scandalous modern equivalent of antiseptic surgery -- things that no one seriously disagrees with, but which the important experts and leadership type people somehow can't lower themselves to pay serious attention to. Or when they pay attention, it's with actions that do nothing to solve the problems.

A good candidate for the poster child of this end of the spectrum is what the CDC calls healthcare-associated infections, HAI's. In other words, getting sick from going to the hospital. Here is the CDC's summary of the situation:

I don't know about you, but this makes me sick. 75,000 preventable deaths in a year, preventable using non-exotic methods. No Cognitive Computing required! There are cures, demonstrated at multiple hospitals that have put serious effort into it. This article summarizes the efforts and approaches, ranging from simple changes of cleaning practices to fancy new machines.

Conclusion

There's a clear spectrum of innovation in healthcare, ranging from blocking-and-tackling basics at one end, to exotic new things based on various forms of Artificial Intelligence at the other end, with smart, non-exotic, data-driven methods occupying the middle ground. Most of the "smart" money appears to be going to the fancy exotic end, with results sometime in the indefinite future, while the rest of the spectrum trundles along, largely under the radar, delivering results to patients today.

Healthcare Innovation: How to Achieve EMR Interchange

EMR interchange has been a major goal of the tens of billions of dollars that have been spent to buy and install EMR's. The theory is that making it easy for the next medical provider you see to have access to your complete health record will improve health. It might! But the current methods for achieving integration are not working. Not. Working. It's easy to understand why they will NEVER work, and what can be done to achieve the same result.

Not to be mysterious about it, here's how: forget EMR interchange. It's not working because it's hard and none of the people who build and control EMR's really want it to work. Instead, enable a new generation of personal EMR's. It's literally hundreds of times easier.

My EMR vs. Integrated EMR's

Everything is great if I go to a single integrated hospital system that uses a single EMR. I go from place to place in the hospital complex, and everyone knows who I am, where I've been and what's going on:

No problem.

The problem happens when I go to an office, a clinic and a hospital. They each have EMR's. What all the "experts" think is best, backed by tens of billions of dollars, is for the systems to talk with each other. What I suggest instead is MyEMR app, which gets the latest information from each EMR and uploads everything to the next place I visit. Here's the choice:

They look pretty similar, right? There are three unique lines (data paths) connecting my EMR to each of the places I've visited, and there are three unique lines connecting each of the providers (H-C, H-O and C-O).

When the numbers grow, they start looking not quite so equivalent. Let's look at six distinct EMR's. With My EMR, there are just six possible connections:

But if the six have to interchange with each other, we're up to 15 possible connections.

Hmmm. Not a good trend. What about when the number gets bigger? What if 100 EMR's had to talk with each other? How many unique connections (data paths) would there be then? Here it is:

You may say there aren't that many vendors. But getting two different installations of EMR software from the same vendor to talk is still a lot of work! Not to mention the fact that there are many different versions, configurations and customizations of each piece of software. The real number is likely to be much larger!

Conclusion

Just installing an enterprise EMR tends to be an incredibly expensive, years-long disaster. There's a good reason based on simple arithmetic that many years and tens of billions of dollars have yet to achieve any meaningful amount of interchange between EMR's -- there's a combinatorial explosion. The same arithmetic strongly favors the personal EMR approach.

Incentives also favor the personal EMR as the center point of integration. How eager is one hospital CEO to make it real painless for patients to go to the competitor? Patients, on the other hand, are highly incented to want the data in their hands; not only would it save endless hours filling out paperwork and avoiding yet another history interview with its inevitable misinformation, but it's likely to help their providers avoid errors and keep them healthier. Of course, the vendors and systems have a death-grip on patient data, and really don't want to give it to patients, regardless of what they might say. But at least sending data to personal EMR's is a solvable problem without a combinatorial explosion of work to get it done.

I want a personal EMR!