PART E, DOCTOR MATH: IF I CAN FIGURE THIS OUT, SO CAN YOU

The first principle is: you must not fool yourself, and you are the easiest person to fool.
--Richard Feynman, Nobel Laureate in physics
It's easier to fool people than to convince them that they have been fooled.
--Often attributed to Mark Twain

Here is medical science explained in four paragraphs. First, our knowledge of what
is happening at a molecular, microscopic, or even conceptual level is close to
nonexistent. Theories about mechanisms are nearly worthless for patient treatment. For
example, we have little understanding of what causes most back pain. Usually,
pretending scan or x-ray abnormalities is the origin or worse, operating on them, is
misguided.
Also, our idea of coronary artery blockage as a simple issue to be solved with
surgical plumbing makes 'sense.' But coronary bypass grafting has been carefully
studied and hardly works. Furthermore, cholesterol is present in artery disease, but
blood cholesterol--and lowering it with drugs--has scant relationship to coronary artery
disease. Another example: the low serotonin theory of depression and the idea that
Prozac and its ilk raise serotonin have been entirely discredited. Marketers, not
scientists concocted the SSRI theory, yet it achieved viral credibility and had been
circulated for decades by both doctors and patients.
Proper medical science is concerned with what we can see and measure rather than
explanations, which can rarely be proven and may be bogus. This means that study
results are vastly more important than speculative commentary about causes. Ever
since I understood this, listening to theoretical discussions causes a buzzing in my head
which makes it hard for me to hear. I get the same buzzing when someone is lying to
me.
But we have commanding weapons in our struggle to untangle fact from ignorance:
our humble mathematicians. They set up and conduct studies which can reveal what
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works for patients, which is the only thing that makes a difference. Their simple ideas
about NNT and relative versus absolute risk can help anyone understand what works.
And they all know, many treatments and tests do not work or at best work poorly.
Unfortunately, like anyone, mathematicians can be bribed. In many cases, our well-
intended rules for drug approval have been gamed by profiteers and cooperative
scientists.

Dr. Yoho has spent his life in a dark rooms looking at powerpoint presentations with his head
buzzing. The complexity of this slide means it is likely useless theory with no relevance to patient
care.

Like most doctors, my statistics training was rudimentary. Compared to 'real docs,'
like Nortin Hadler, a respected biostatistician, I am just a journalist-entertainer. His
profession believes if more than 50 people need to be treated to create one person's
improvement, such a result is barely measurable and would not be likely replicated in
further studies. In his book Worried Sick (2008), he says the following therapies are
worthless as measured using that standard, with the best studies available:

Coronary artery bypass grafts, angioplasties, or stents to save lives or improve symptoms
Arthroscopy for knee pain
Any surgery for backache
Statin therapy to reduce cholesterol and thereby save lives
Newer antidepressants for situational depression
Drugs for decreased bone density
PSA screening and radical prostatectomy to save lives
Screening mammography to save lives
Many a cancer treatment to save lives

He goes on: '... if I have to treat more than twenty patients to do something really
meaningful for one, I regard the treatment as marginal... Furthermore, designing trials to
test whether new or old treatments meet this one-in-twenty level of effectiveness is not
difficult, expensive, or time-consuming.' His point is that statisticians believe only half of
what doctors do works. The congressional budget office agrees; they estimate 30
percent of medical care is 'unnecessary.' Other authorities using the 'Milliman Health
Waste Calculator' say useless medical activities are 48 percent. Since many treatments
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are risky, this is more critical than just squandered money. Most doctors never learn this
simple math, and I discovered it only recently. Bear with me beating this horse a few
times, and you will understand healthcare.

Idea one: the 'number needed to treat' (NNT). Dr. Hadler's message--worth
repeating--is that treating more than twenty patients--fifty at the very most--to produce
one effect is witchcraft, not medicine.
Much of what we do does not meet this standard. When you understand the NNT,
you will effortlessly see through deceptive numbers and confidently judge medical
studies. TheNNT.com explains more and explains hundreds of therapies using this
simple measure. Nortin Hadler makes it more clear in his book Stabbed in the Back
(2009):

What NNT does one need in order to declare the effectiveness clinically meaningful? I, and most
others who are students of this exercise, would argue that an NNT of fifty is the upper limit of
reliability and of meaningfulness. This means that a physician would need to treat fifty people for
one of them to stand a good chance of benefiting. I would personally be more comfortable with an
NNT of twenty or less for my cutoff. ...These cutoffs are defensible when the outcome is "hard"
(unequivocal), such as death, heart attack, end-stage renal disease, and the like. But ... the effect has
to be clinically meaningful ... If the intervention spares one in twenty from death by colon cancer
but spares none of these from death by something else at the same time (all-cause mortality), the
clinically meaningful NNT is not twenty, since there is no meaningful result. Death is death. NNTs
for "soft" outcomes are to more problematic. How much better do you have to make patients with
rheumatoid arthritis feel, and how many patients must you treat, before you would consider the
effectiveness clinically meaningful? ...NNTs of five are likely.

Idea two: Relative versus absolute risks. To illustrate this, consider colonoscopy
screening of asymptomatic patients used to find a new cancer. At 40 years old, a
person might have a two percent chance of dying from colon cancer before he is 80, the
RELATIVE risk. However, his chances of dying from all other causes before 80 is about
60 percent, the ABSOLUTE risk. Even if we had a cheap, easy procedure which
identified then cured all colon cancers, it could only make a two percent improvement in
ABSOLUTE deaths. But our testing and treatment do not work that well.
The gastroenterologists talk about RELATIVE RISK improvement and even fool
other doctors. Here is how it works. Suppose out of the two percent who would die of
colon cancer, they save one percent if we tolerate all the risk, expense, and discomfort
of using the scope every five to ten years, and everyone cooperates with the test. This
is a lot of 'ifs,' but suppose it were true. A gastroenterologist might say he was
decreasing the RELATIVE death rate by 1/2 = 50 percent.
It sounds impressive. But the improvement in ABSOLUTE risk, the only thing that
matters, is 1/60 = 1.6 percent, which is almost unmeasurable (the reciprocal is 62, the
NNT, which is high).
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COMMENT:
Explaining absolute risk like this makes it way more confusing than it needs to be.

When the dangers, costs, and ineffectiveness of colonoscopy are considered, risk
improvement is negligible. And, we still have no randomized controlled trial showing it is
effective at all.
Endoscopy doesn't find all the tumors, and it causes bleeding or colon perforation
five times every thousand cases. These require hospitalization and possibly surgery,
and there are even rare fatalities.
Also, there are sedation, colon preparation, expensive scopes, facility fees, and
expert gastroenterologists' time to be considered. There are stress, expense, and
patient hassles. When the above is factored into the 60 percent ABSOLUTE death rate
between 40 and 80 years old, colonoscopies do not make patients live longer: there is
no improvement in ABSOLUTE death risk. A stool blood testing program does not find
all cancer either, and it promotes colonoscopies. The math is the same.
For further confirmation of ideas like these, see a paper in the most prestigious
medical journal in the world, the New England Journal of Medicine. This study said
sigmoidoscopy (scoping the lower half of the colon) saves lives because 50 percent
fewer died of colon cancer, the RELATIVE risk. But the math does not support
sigmoidoscopy, either. The improvement in all causes of death or ABSOLUTE risk was
shown only to be 1/1000.
This means the NNT was 1000 over an eleven-year period to save a single life.
David H. Hoch, M.D., Ph.D., concluded in a published follow-up letter, 'Studies that are
purporting to influence public health policy should be required to compare the relative
and absolute benefits of the proposed treatment.' But the learned editors somehow
gave the original article a pass.
Also note: sigmoidoscopy is cheap, safe, and easy compared to colonoscopy.
Physicians are closer to painters than engineers: our whole thing is artwork. We must
not make unequivocal arguments. Dr. Hadler, for example, had a friend who died of
colon cancer. A sigmoidoscopy at 55 years old would have saved him. So he believes
sigmoidoscopy screening is reasonable, even though the numbers do not support this
idea.
People who find blood in their stools are not part of these numbers. They get
discovered because of the symptom. We then do an endoscopy and possibly surgery
for them as appropriate. There are others, such as Crohn's disease, ulcerative colitis, or
people with a family history of colon cancer in a sibling or parent (a 'first-degree'
relative), who should be scoped at intervals because their chance of getting cancer is so
much higher.
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Relative versus absolute risk and the NNT says screening mammograms are likely
worthless if a large enough study was done. The problem is the same as with
colonoscopy. We spend enormous time, energy, money and even the (slightly risky)
follow-up surgery, but positive effects are so small that the math does not work.
J. Michael Dixon, a breast surgeon and vocal advocate of mammograms, says that
for every 400 women screened for ten years--4000 years of screening!--one woman
would be spared a breast cancer death. Is this an NNT of 400 or 4000? Well, no matter.
It is a meaninglessly small number, but he somehow thinks it is worth it. His opinion
must be discredited because he makes money on the procedures. And he obviously
has no understanding of 'doctor math.'
One more time, with real figures. If we screen 1000 women with mammograms for
ten years, six will die from breast cancer anyway. And if another 1000 women have no
mammograms for ten years, nine will die from breast cancer. We have 'saved' three, a
theoretical RELATIVE risk improvement of 3/9, a third. But the ABSOLUTE
improvement is only 3/1000, a loser. The NNT is 1000/3, or 333.
This program spawns expense, anxiety, thousands of mammograms 1, numerous
biopsies, chemotherapy, radiation exposure, and even a few deaths from surgery. And
we are screening them for ten years... 10,000 patent-years! The identification of the
tumors forces us to treat some insignificant cancers. Neither the patient nor the doctor
would ever notice many slow-growing tumors. If we left them alone, many of these
women would die 'with and not from' breast cancer. Dr. Gøtzsche lays out the story in
his book, Mammography Screening (2012).

Mammograms sometimes direct a surgeon to do a biopsy which shows ductal

carcinoma in situ (DCIS). Also called intraductal carcinoma, it was initially thought to be
pre-cancerous or non-invasive breast cancer.
A double mastectomy is sometimes performed for DCIS, and most authorities
recommend at least lump removal and possibly radiation therapy. A study of 120,000
patients undergoing various surgery and radiation choices (there was no control group
without treatment) showed 'The choice of locoregional treatment had a strikingly small
impact on breast cancer-specific survival, calling for a more thoughtful and restrained
treatment approach for this disease.' What has not been carefully studied, but is likely
true, is that not treating at all probably has the same outcome for ABSOLUTE (all-
cause) death rate after a DCIS diagnosis as treatment.

1. Mammograms have a huge literature in which they are proven to be an inaccurate predictor of cancer
anyway. Radiologists cannot consistently read the tests, even when given the same films over and over,
and there are many false positives and negatives. But the current theory goes, a biopsy is necessary for
anything suspicious.
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I will go one step further: DCIS seems like a scam to me. The following are very
simpleminded and approximate DCIS statistics comparing DCIS with real breast cancer.

✪ Twelve percent (.12) of all women get breast cancer.

✪ After a breast cancer diagnosis, 10-20 percent die within ten years.
✪ So if you have no breast cancer, your chances of dying of breast cancer within ten years are
about: .12 x 10-12 percent = 1.2-1.4 percent. Nearly all fatalities occur in this period.
✪ After DCIS diagnosis, 1.1 percent die within ten years, the same. Lifetime death rates are
about 2 percent. This is pretty close to the same thing.

Some studies even say that ten years after a DCIS diagnosis, a patient is slightly
more likely to have died from breast cancer but less likely to have died overall. All this
seems to make DCIS a fake diagnosis. Treatments and patient age may confound my
schoolyard analysis somewhat, so do your reading and use your judgment; I am not an
oncologist or a statistician.
Jason is a neurosurgeon who explains relative and absolute risk to his patients:
a.
a. THEY GET IT IMMEDIATELY (Emphasis his). I speak from personal experience. My
mother had a biopsy showing DCIS of her breast. Her very patient doctor gave her a
bunch of options. When I explained absolute risk to her, she understood. She made a
great choice. More importantly, she felt relieved. The scare was over. What's
unfortunate is that many doctors don't appreciate the difference.'

There are many opinions about mammography--and everyone admits there is

controversy. Unfortunately, it is now a 'feminist issue,' acquiring a patina of political
correctness, despite the dearth of scientific support. But when the utility of a test is
unclear, when there are many different ideas, we should spend the money on
something else. The following story tells of a person who followed standard medical
advice. She ignored me when I said that the breast cancer screening and prevention
strategies are barely credible and that most of the supposed 'advances' were due to
earlier identification of a heterogeneous and unpredictable process. And that even if the
cancer was identified the treatment strategies were poor.

Jane was 38 and already had a hysterectomy for adenomyosis which caused bleeding and
cramping. She was never offered birth control pills, uterine ablation or uterine artery embolization.
Although her ovaries were not removed, her energy declined, and her testosterone levels were
zero. Testosterone cream helped.
Her general surgeon has been chopping out her breast lumps for years. Her mammograms were
normal, but he said he was preventing breast cancer. When she complained, she was sent for an
MRI ($1850). The radiologist said she had a 'very worrisome' new area.
He told her he would do an MRI-guided needle biopsy ($3500, plus a facility fee), but would
likely puncture her breast implants. She went for a second opinion and was referred 2800 miles
away to Miami where she had the ten-minute procedure for $8700 ($3200 out-of-pocket). The
biopsy showed nothing, but the radiologist recommended a repeat MRI every six months.
Jane's lumps were 1/4 inch in diameter and right under the skin, but the local surgeons all
refused to remove them unless she went to their certified surgical centers and used general
anesthesia. Medicines make her sick, so she found a surgeon who told her he would use local. But an
anesthesiologist gave her a lot of medication anyway ($21,500 for the day with the anesthesia and
surgicenter). Her incision was 3/4 inch long.
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Relative versus absolute risk shows the statin anti-cholesterol drugs do not work for
'primary prevention' of those without prior heart disease. For example, Pravachol® is
expensive and sometimes toxic, with potential for brain, muscle, and other damage. But
it supposedly decreases the chance of a nonfatal heart attack by 2 percent after five
years. The placebo group's heart attack rate was 6.5 percent in the group studied, so
the manufacturers describe RELATIVE risk reduction in heart attacks as 2/6.5 or nearly
third.
Does this sound good? If you like it, you must also believe there was no study
fakery. But the ABSOLUTE risk reduction--the heart attack reduction considering all the
people in the study group--is two percent (NNT of 50). And there was no impact on
deaths (an actual hard endpoint), so the ABSOLUTE risk reduction for death is zero. So
is it worth taking this toxic stuff for five years for a two percent reduction of non-fatal
heart attacks, with no impact on mortality? Forget it.
Another example of statistical frauds with statins is Crestor. This very successful
drug is heavily marketed: $170 million in direct-to-consumer advertising was spent in
2007 alone. The manufacturer then sought another market: people with normal
cholesterols! Their "JUPITER" trial used 18,000 patients in 1200 centers. It was run by
academic physicians mostly with declared interests in the statin industry, including
Crestor. They monitored heart attacks, strokes, coronary artery surgery, and heart
deaths.
After less than two years of the five years, they stopped the trial. They found the
relative risk of some of the above factors was 56 percent less for the group taking
Crestor, based on an event rate of .77 for those taking Crestor and 1.36 for those on
placebo: .77/1.36 = .56. Then they broadcast the 'lifesaving' properties of the medicine.
That is what they are supposed to do, right?
Not exactly. Nortin Hadler calculated an NNT of 400 to cut out one stroke and one
heart attack (he says there was no evidence of decreased deaths in the data). This is
too small to measure adequately and likely not reproducible. Also, during a years-long
experiment like this, the statistics swing back and forth. When such a trial is stopped
prematurely, before the planned finish, a temporary aberration in the numbers might be
used to obtain a desired result. This is a bias similar to the 'data torturing' described
below.

Osteoporosis treatment with bisphosphonates is nearly the same story. The often-
quoted relative risk reduction is about 40 percent, but the NNT is 100 women for three
years, which means the absolute risk reduction is 1 percent or less. If they work at all,
the effects of the drugs are too small to make up for the chance of the patient's jaw
rotting or having some other absurd complication from the toxicity.
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This dirty little secret of medical studies is there for anyone to see. Nearly all trumpet
their results for RELATIVE risk rather than ABSOLUTE risk, which is almost
meaningless. Refuse to trust abstracts, summaries, and interpretations of medical
literature, as they commonly present only these RELATIVE risk findings.

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BEATING THE DOCTOR MATH HORSE: USELESS 'SCREENING' TESTS

Medical testing is traditionally--and quite reasonably--used to clarify what is

happening after a patient has developed a problem. However, tests are now often
employed for 'screening:' an attempt to diagnose conditions before they have
happened, hoping to prevent them. Although this sounds reasonable, it is mostly
ineffective, especially in older people. In particular, after about 75 years of age, very
little medical care is likely to impact the absolute risk of death. These patients have
limited time, and usually fall prey to something else not under consideration even if we
'save' them from a disease. These patients need our respect and support, but using
medical technology on them may border on assault.
Many drugs (such as blood pressure, blood sugar, or cholesterol medications) are
used in a similar attempt to prevent rather than treat diseases. These activities are
hugely profitable and have transformed nearly everyone into a patient.
To review the last chapter: suppose a diagnostic test, procedure, or drug produces a
50 percent reduction in the chances of a disease (the 'relative' risk). This sounds
impressive, and it is how researchers generally present--or inflate--their findings.
However, since many diseases account for one percent of ALL deaths, such an
improvement might account for only 1/2 percent actual reduction in total deaths,
generally the most important consideration (the 'absolute' risk). This is too small to be
measurable or reproducible.
Once you understand this, commonly used routines like colonoscopy,
mammograms, cholesterol medicine, and even checking the stool for blood in healthy
patients can be seen as a waste of time and money. Worse, they spawn further useless,
expensive and sometimes hazardous medical activity.

Although little mathematical support exists for screening tests on asymptomatic

patients, the United States Preventive Services Task Force (USPSTF) has produced
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'state of the art' recommendations for every imaginable testing issue. A lot of it is
sensible--they often recommend no screening. To their credit, they debunked PSA
screening for prostate cancer. But refer to what they say about depression screening
and compare it to what you now know about psychiatry:

The USPSTF recommends screening for depression in the general adult population, including
pregnant and postpartum women. Screening should be implemented with adequate systems in
place to ensure accurate diagnosis, effective treatment, and appropriate follow-up.

So draw their own conclusions about the USPSTF. Likewise, be careful about
believing other medical authorities. The following are cautionary tales about medical
screening.

Doctor math does not support colonoscopy on asymptomatic patients looking for
colon cancer. Patients who have known problems are different. Those with bleeding,
Crohn's disease, ulcerative colitis, hereditary polyposis, (people with hundreds of polyps
inside their colons), and those with siblings or parents with colon cancer all likely have
their lives extended by colonoscopies.
This procedure costs billions of dollars every year in the US. There are risks
including bleeding, colonic puncture, and even, rarely, death. In private,
gastroenterologists (GIs) refer to colonoscopy as 'grabbing a $1000 bill out of there'
(overheard by a nurse who worked in a gastrointestinal laboratory). Some of them bring
patients back as soon as they can, rather than relying on standardized intervals for
repeating the procedure. Variations by region also give evidence of overuse.
Recently, the American Cancer Society has recommended starting screening at only
45 years old. Other countries keep better control over their profiteering
gastroenterologists. Most of their standards are to check the stool and only if there is
blood to do a colonoscopy.
"Snaring polyps" is the removal of nipple-like fleshy lumps sticking out of the inside
of the bowel using wire loops. Since they are sometimes pre-cancerous, taking them out
has been theorized to decrease chances of real cancer developing later. The money
from this alone can be half a gastroenterologist's income. Turning this trick is the GI's
main lucrative procedure. But with the pay comes temptations. An anonymous
gastrointestinal lab nurse working in a revered Los Angeles hospital said this:

About half the gastroenterologists (GI) dos here are crooks. With every single colonoscopy, they
suck a little piece of bowel wall into the scope and snip off this normal tissue and send it to the lab.
The call it a polyp and bill thousands for the removals. The pathologists cooperatively report it as
"polyp with non-specific dysplasia" when they look at the specimen under the microscope. These
GI's are one-trick ponies when it comes to making money. Colon scoping is all they have besides an
occasional ERCP (Endoscopic Retrograde Cholangio-Pancreatography), which is a lot harder.
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Sigmoidoscopy, looking at the bottom half of the colon rather than the whole thing, is
much safer, a tenth of the price, and requires little skill and no sedation. Nortin Hadler
wrote, 'Recent trials suggest that screening colonoscopy offers no improvement in risk
reduction over flexible sigmoidoscopy. Furthermore, polyps have such prolonged "dwell
times" that the only clinically meaningful risk they impart is in the seduction of removal.'
John Abrahamson, the author of Overdosed America, agrees and cites the studies. He
says he does not want anyone touching his polyps.
We now have Cologuard®, a simple $600 stool test now reimbursed by Medicare. It
is typical corporate pricing: as high as they can get away with. But when compared to
colonoscopy, which costs $2000 and has risks, it seems almost reasonable. Cologuard
detects 92 percent of colon cancers and 42 percent of advanced polyps each time with
each use. Since colon cancer is slow-growing, with a reasonably predictable history, this
potentially gives doctors time to determine what is happening with a colonoscopy, and
usually time to cut out a colon cancer before it spreads beyond the wall of the colon.
After two uses, the cancer discovery rate might be better than a colonoscopy, according
to the author's math. The gastroenterologists are not enthusiastic.

Urology has undergone an embarrassing outing by the rest of the medical

community. The specialty has traditionally recommended checking men's prostates
using the doctor's finger and a prostate-specific antigen (PSA) blood tests to screen for
prostate cancer. After this, they follow up with painful biopsies and perilous surgeries if
the biopsies show anything. But after close analysis, none of this improved death rates,
and it has been discredited.
Prostate cancer is present but inactive in most men over 50. But available
treatments do not make men live longer on average. Described another way, ignoring all
of these tumors has same ultimate fatality rates as treating it, but without the horrific
surgical complications. With the operation, called a 'radical prostatectomy,' there are
many cases of impotence and incontinence, which is peeing yourself with diapers
required.
Most of these tumors grow so slowly that they do not become symptomatic before
death occurs from other causes. For some, the disease is metastatic before the surgery
so that they would have died from it anyway. PSA does not identify cancer very well,
anyway. Prostate irritations such as prostate infection (prostatitis) are common and
cause the PSA to rise. Prostate irritations such as prostate infection (prostatitis) are
common and cause the PSA to rise. Antibiotics are used to treat this rather than
surgery.
The American Veterans Administration 'PIVOT' trial compared surgery versus
observation for localized prostate cancer over a 13-year period. There was no
statistically or clinically significant difference in either all-cause or disease-specific
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mortality. A Scandinavian study published in the NEJM compared 695 men with prostate
cancer and divided them into two groups. Some had radical prostatectomy surgery, and
the rest had 'watchful waiting.' Although with radical prostatectomy, men are less likely
to die of prostate cancer (RELATIVE death rate), their overall death rates five or ten
years later was the same (the ABSOLUTE death rate). The average age at death was
the same.
These authors have the gall to claim various benefits from the surgery, but it
amounts to hand-waving considering what the horrible hassles of an operation. Their
study shows the procedure only reduces a man's (RELATIVE) risk of dying from
prostate cancer at best by half (another study, the 'ERSPC' showed only 20 percent
improvement).
The USPSTF rejected checking the PSA in healthy men after evaluating the
studies2. The best path is to pretend you do not have a prostate unless you have
symptoms.
The most favorable spin for this: controversy rages about whether there is any
benefit from the billions of dollars of mutilating surgeries and painful biopsies produced
by prostate cancer diagnosis and treatment.
Greedy doctors using these mistaken ideas attacked my friend Jack, but fortunately,
his 'caregivers' were unable to justify a radical prostatectomy:

Jack is72 and goes to the 'best' urologists in San Francisco. He had a PSA of only two, but his
doctors recommended an MRI of the prostate (the urologists' 'standard' is to biopsy only if the PSA
is over 4). It supposedly found areas of concern, so they biopsied his prostate in sixteen places,
which was very painful. Since the biopsy, he has had swelling, which caused problems urinating.
They then gave him Flomax®, a drug to make urinating easier. It has the side effect of 'retrograde
ejaculation.' This means the sperm goes into the bladder instead of out of the body, and Jack hates it.
He has the 'best' insurance, and they paid $16,000 for all this.

Urologists continued to aggressively recommend PSA screening for anyone over 40

with a prostate through 2009. But they partially responded to the heckling from the rest
of the medical community by 2013. Their guidelines that year recommended
'individualizing' this test using patient input for ages 55 to 69:

For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening
involves weighing the benefits of preventing prostate cancer mortality in 1 man for every 1,000 men
screened over a decade against the known potential harms associated with screening and
treatment. For this reason, the Panel strongly recommends shared decision-making for men age 55

2. They have analyzed the data from the PLCO, ERSPC, and other trials and estimated that, for every
1,000 men ages 55 to 69 years who are screened every 1 to 4 years for a decade, a single death from
prostate cancer would be avoided. 100 to 120 men would have a false-positive test result that leads to a
biopsy, and about one-third of the men who get a biopsy would experience at least moderately
bothersome symptoms from the biopsy. 110 men would be diagnosed with prostate cancer. About 50 of
these men would have a complication from treatment, including erectile dysfunction in 29 men, urinary
incontinence in 18 men, serious cardiovascular events in 2 men, deep vein thrombosis or pulmonary
embolism in 1 man, and death due to the treatment in less than one man.
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to 69 years that are considering PSA screening, and proceeding based on a man's values and
preferences.

Since most doctors do not understand these issues, I am not sure how any patient
possibly could. As you see, they confirmed the NNT was far too high for the treatment to
be useful. It was virtually identical to colonoscopy: 1000, or was it 5,000 or 10,000?
Were the patients checked every year or two years?
N.B. The PSA test when used for purposes other than screening may be useful.
Monitoring the therapy of metastatic prostate cancer is an example.

Screening mammograms are a terrific waste of time and money and are a net
negative for health after accounting for the invasive procedures they spawn. A massive
Cochrane review concluded they are without merit. Hippocrates Shadow (2008) by
David Newman and an excellent NY Times article also describe the situation. Recently
the French joined Switzerland in entirely abolishing the recommendation for any
screening mammography.
A JAMA study showed increased pick-up of breast cancers (incidence) with
mammograms but no change in deaths. They said, 'these findings suggest widespread
overdiagnosis.' In other words, for all the frenzied activity around mammograms and
breast biopsies after them, this program does little good. Even breast cancer
chemotherapy is becoming discredited: a recent NEJM study said it did not help the
early stages. As can be seen in the following graph from the National Cancer Institute,
neither deaths nor new breast cancer diagnoses in the USA have been changing much.

The charities supporting breast cancer prevention are money machines serving little
useful purpose: their premise is an intellectual fraud. Additionally, they spend a jumbo
proportion of their revenue on expenses such as advertising and payroll, perpetrating
their administration rather than serving their purported purpose. For example, the
American Cancer Society and the United Breast Cancer Foundation each spend 40
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percent on overhead, earning them a dismal two out of four-star rating at

charitynavigator.org.
The physician specialists such as radiology which support mammograms are lining
their own pockets. The surgeons who do the biopsies are wasting resources and taking
risks with their patients' health. The congressional committees which support
mammograms are grandstanding.

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EASY DOCTOR MATH UNMASKS THE FOUR HORSEMEN OF STUDY TREACHERY

1) Studies with a cast of thousands are attempting to find tiny differences, but this
sort of 'discovery' is of no practical importance--and might turn out differently in another
study. The drugs in the Fraudulent Medicines chapter are examples. They were
promoted after massive study, which showed them to be nearly worthless. When
thousands of patients are required to see 'statistical significance,' they actually show the
treatments barely work.
Cancer trials, for example, use gargantuan numbers to 'prove' therapies work. Dr.
Hadler in his Worried Sick (2008) elaborates: 'The literature on adjuvant (chemotherapy)
medical interventions is extensive. There are multiple trials. Some are designed to
recruit thousands of patients for randomization. Whenever I see a trial with thousands of
subjects, I bridle.... in large trials seeking tiny effects, randomization errors can never be
avoided. The very fact that the Canadian and Swedish investigators (of mammogram
screening for breast cancer) felt compelled to design trials with tens of thousands of
subjects followed for decades says to me that the health effect they target is too tiny to
measure and too small to be meaningful. I don't think such trials should ever be done.
They are not necessary.'
Hadler admits his peers love the humongous studies, and that he is in the minority.
Also, the reader does not have to understand the math to see the conflicts of interests.
Tragically vulnerable patients, sometimes at the end of their lives, are being tortured for
money.

2) Randomized controlled trials (RCT) are now regarded as the gold standard for
establishing medical knowledge. Unfortunately, they are being distorted by industry.
These are studies where groups of patients are selected for a therapy and then
compared to either placebo or another treatment. The subjects are ideally chosen
based on chance, and the investigators and patients are 'blinded.' This means neither
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patients nor doctors know which was the real drug treatment and which was the 'fake'
until after the study was over. 'Statistical significance' is the standard by which the
results are judged.
Controlled trials are complicated, expensive operations, lousy with opportunities for
manipulation by those with money to make. One commonly used lie is saying findings
which are not statistically significant do not exist. But if there are more deaths in the
treatment group, this must be investigated. Sometimes new figures are even cooked up,
or the patients in the study groups are changed at the end.
Marcia Angell was the editor of The New England Journal of Medicine (NEJM). She
reported in The Truth About the Drug Companies (2004) that companies sponsoring
studies often required placebo controls rather than active controls. This guarantees a
new drug cannot look bad against an old one.
The first principle of research should always be, 'Does it make sense?' Many times,
this is absent. When the purpose of a study is to justify selling drugs, and there is a
desired predetermined result, the process is marketing and not science. This is the
situation Mark Twain was referring to when he said, 'There are three kinds of lies: lies,
damned lies, and statistics3.'
Gordon Smith in the BMJ wrote the classic parody of RCTs. He said that studies of
parachutes with randomized controlled trials have not yet been performed. Such a test
would, of course, involve a control group without parachutes. He suggested that the
most rabid advocates of statistical studies should participate, with and without
parachutes.
Much of medical knowledge does not need statistical study. Relocating a dislocated
shoulder is an example. It works, and the pain vanishes. The short-term benefit of
morphine, used for centuries, is obvious. And at one time, penicillin worked for
pneumonia in nearly every patient.
Charlie Poole, professor of statistics and epidemiology at University of North
Carolina said, 'Controlled trials, which began as a means of protecting patients from the
biases of doctors, have become instead a method to enhance business in great part
because drug companies have managed to hook doctors to the crack pipe of statistical
significance.' And Dr. Healy says, 'statistical significance should be abandoned
immediately and universally.'

3) 'Data torturing' is a commonly practiced intellectual fraud. Large studies have

many variables, such as patient age, sex, different medical problems and so forth. After
the finish of a study, computer analysis may be used to examine many 'relationships'
between these variables. 'Statistical significance' is supposedly credible if there is only
one chance in twenty of a relationship happening by chance. But if a hundred
3. Twain was quoting Disraeli, possibly misquoting him.
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relationships are studied, five (one in twenty) will look like they have a statistically
significant connection, but it would be due to chance alone.
If investigators do not carefully define what is being looked at before a study starts,
this idiocy is inevitable. Many papers are published, and conclusions are drawn based
on this data torturing, or 'subset analysis,' which is a meaningless fishing trip looking for
something to promote careers after a study is over. Data torturing must be prohibited by
international law, like real torture. Successful treatments do not need armies of study
subjects and Ph.D. mathematicians 'torturing data' to find 'statistical significance.'

4) The FDA has been approving most drugs in recent years based on studies
measuring 'soft' or surrogate endpoints. These include blood sugar, blood pressure,
bone density, cholesterol, or tumor size reduction. In psychiatry, the evaluations are
even weaker because they are subjective. Examples of 'hard' endpoints, on the other
hand, are stroke, death, blindness or bone fracture.
Death is the most accurate 'hard endpoint' for medical research. No equivocation is
possible. Stroke or heart attack rate or even hospital stay days might seem like
reasonable hard endpoints, but if the death rate is not affected, the true patient benefit
must be carefully evaluated. Measures such as laboratory values are called 'surrogate'
or soft endpoints. Researchers claim they 'validate' the surrogates' relationship to the
hard outcomes. Gøtzsche summarizes it best in Deadly Medicines and Organised
Crime: 'Sometimes, researchers declare they have validated a surrogate marker. Don't
believe them, as it cannot be done. All drugs have many effects, and we cannot pick just
one of them and say that this effect will tell us what we need to know.' When
researchers use hard endpoints, their conclusions typically do not match those found
with soft ones.
This is a crucial debate because if improper endpoints are used, study conclusions
are erroneous. The surrogate endpoint hoax has legitimized toxic, horrifically expensive
drugs and therapies, and sabotages our health and finances. The FDA, unfortunately,
permits medication approval based solely on surrogate endpoints, which undermines
medical knowledge.
For example, for diabetes, the surrogates used are blood sugar or hemoglobin A1C,
which measures average blood sugar. But Sameer A. Kassem, MD, Ph.D., in The
American Diabetes Association Journal says, '...there is no compelling evidence that
improving glycemic control has, in itself, beneficial effects on macrovascular
complications and cardiovascular clinical endpoints.' This means better blood sugar
control does not improve chances of heart disease and stroke.
The simplest explanation is: a surrogate endpoint is when the patient does not know
there is an improvement until the doctor tells them. Now you get it.
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We cannot blame lousy research entirely on industry. John P. A. Ioannidis discussed

a discouraging array of scientific confusions and biases in 'Why Most Published
Research Findings Are False' (2005). Among many other issues, 'publication bias' is a
big problem. It is the tendency to print 'news' of recent findings, and leave unpublished
boring stories of 'negative' studies which don't show an exciting outcome. He says:

Simulations show that for most study designs and settings, it is more likely for a research claim
to be false than true. Moreover, for many current scientific fields, claimed research findings may
often be simply accurate measures of the prevailing bias.

He is not writing about conflicts of interests or supported medical industries trying to

develop evidence for their profitable drugs or devices, but about the ways our
publication system confounds truth.

MAY I TELL YOU WHAT I REALLY THINK?

Physicians try to be ethical. Most of us--including myself until recently--know no

more doctor math than a house cat. Even surgeons who appear to be carving for dollars
are mostly guileless and naive. With a few exceptions, the press is even more clueless.
Their currency is what people say: social proof. To sell their stories, they always present
the 'two sides of the issue' rather than analysis, which does not seem to be in their job
description. So medical stories reported in the media, particularly about cures, are
entirely unreliable. But this is not news.
The sick part of the story is that brilliant adults are observing everything these
children are doing without intervening or drawing limits of any kind. I once again present
the journal editors. They fully understand 'evidence-based medicine' is smoke and
mirrors, but have been paid to stay silent and continue to publish whatever pays. Jason
Fung says the following in a blog:

Does the CEO of Phillip Morris (maker of Marlboro cigarettes) smoke? That tells you all you
need to know about the health risks. Do the editors of the NEJM and the Lancet believe (evidence-
based medicine) anymore? Not at all. So neither should we. We can't believe evidence-based
medicine until the evidence has been cleaned up from the corrupting influence of commercial
interests.

Journal editors should be water-boarded by a committee of readers each time they

disgrace themselves by publishing data torturing. The penalty for approving surrogate
endpoint studies or claiming that an NNT over 50 was meaningful might be ten lashes
delivered in Singapore. The same goes for each mention of relative risk, for which the
sentence should be a year in a Thailand jail. Am I barbaric, or are these punishments
mild? Think of the harm done by these publications, billions of wasted dollars and
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possibly hundreds of thousands of lives lost each year. The editors know what they are
doing, they do it for the money, and they fool nearly everyone.