October 2011, Week 2


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Sun, 9 Oct 2011 13:43:00 -0400
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To Portside:

For those of you in possession of a prostate gland who
have been urged to have it tested - and those of you
concerned with the explosion of screening tests from
mammograms to colonoscopies now recommended routinely by
doctors, you might want to see an article my colleague,
Shannon Brownlee, and I wrote that just appeared online
in the New York Times Magazine

[moderator: the article is reprinted following this 

(it will appear in this Sunday's print edition). In the
article we examine the science behind prostate cancer
screening, with mention of the potential harms of other
screening tests.

Many men have reacted strongly to our article and to the
recent announcement that the United States Preventive
Services Task Force is now recommending against prostate
cancer screening for men of any age. Many relate their
personal history of being screened with the prostate
specific antigen (PSA) test for prostate cancer and they
say their lives were saved. Without the test they would
be dead. In light of this sort of outpouring of
reaction, it can seem impossible to believe that so many
men could be wrong.

But to understand how it could be that the test could be
useless and even harmful -- yet so many men can dominate
the comment boards at the New York Times, one must
understand Big Pharma, Big Medicine, it's largesse, and
exactly how they have cultivated faith-based and not
science-based medicine.

I won't reprise our article here; please read it to
understand how the claims that the test "saves lives"
has been misreported, misleading, and just plain wrong.
But to understand how so many men can testify, one needs
to understand how people are alerted to articles, how
they respond, and why their response seems to be so
relatively uniform (with notable exceptions). First, Big
Pharma funds many "lay" disease-oriented groups. It
provides a wonderfully effective end-run around
advertising costs, FDA regulations, and provides a tax-
deductible benefit for the companies. Excellent
investigative articles have already revealed the
extensive funding of many lay psychiatric survivor
groups that promote psychiatric medicines. The same
process is at play with many men's groups, like UsToo
and Zero, that have promoted testing.

When an article comes out like ours, these groups are
activated and very well meaning and heart-felt messages
are posted by men who have come to believe that in fact,
if they hadn't had their prostates removed, radiated or
treated with chemicals, that they would be dead. But who
tells them they would be dead? Surely some would, but
the vast majority would never have died anyway.

And what of the men who are dead because despite
screening they died anyway - or because they died from
the biopsies and treatments? Yes, what of them? They can
hardly post counter arguments on the New York Times
website. Instead, it is left to people like my colleague
and me who are hardly as compelling as a man writing in
to say how cancer had spread throughout his prostate
gland and just in time, the doctors cut it out, and now,
now I am cured.

Others have posted their belief that screening skeptics
are "deathers" just trying to "ration care" to spare the
government money.

Nothing could be further from the truth.  Our concern in
writing the article is first and foremost the medical
harm done by unproven screening tests that can suck many
people into a cascade of further invasive testing and
treatments that carry substantial risks - risks that are
too often ignored by researchers who report narrowly
defined benefits without reporting harms - and who make
enormous profits in the process.

The real money in the game has been the extraordinary
profits accrued to those who have promoted the belief
that every single healthy person is only seemingly
healthy until they have every organ, every gland, every
inch of our body tested, invaded, and scrutinized
because we might be harboring some unknown disease. They
exaggerate the risks to scare us into action when
ultimately, what matters, and the question we examine in
our article is very simple: Does the test help - or
doesn't it?

Jeanne Lenzer and Shannon Brownlee

Can Cancer Ever Be Ignored?
New York Times
October 5, 2011

As chief medical and scientific officer of the American
Cancer Society, Otis Webb Brawley - who is also a
professor of oncology and epidemiology at Emory
University - is the public face of the cancer
establishment. He operates in a world of similarly high-
achieving, multiple-credentialed, respectable
professionals, where insults tend to be delivered,
stiletto-style, in scientific language that lay people
aren't meant to understand. So it can be more than a
little jarring to hear, for example, James Mohler,
chairman of the urology department and associate
director of the Roswell Park Cancer Institute in
Buffalo, say of his friend: "I have known Otis for over
20 years. He doesn't come off as being ignorant or
stupid, but when it comes to prostate-cancer screening,
he must not be as intelligent as he seems." Or Skip
Lockwood, the head of Zero, a prostate-cancer patient
advocacy group, charge that Brawley is more concerned
about saving men's sex lives than about saving the men

Brawley has become the target of these attacks because
of his blunt and very public skepticism about the
routine use of the prostate-specific antigen, or P.S.A.,
test to screen men for early prostate cancer. "I'm not
against prostate-cancer screening," Brawley says. "I'm
against lying to men. I'm against exaggerating the
evidence to get men to get screened. We should tell
people what we know, what we don't know and what we
simply believe."

The P.S.A. test, which was approved by the U.S. Food and
Drug Administration in 1986, has become an annual ritual
for millions of middle-aged men who assume that finding
prostate cancer early will prevent death. By 2008,
nearly half of men over 50 reported that they were
screened in the previous 12 months. Despite the seeming
logic of the P.S.A. test, the evidence that it saves
lives is far from conclusive, and Brawley is not the
only one questioning it. A growing cadre of doctors,
epidemiologists, patients and cancer biologists are
rethinking its value. And the most recent studies, while
not ending the debate, indicate that routine P.S.A.
testing appears not to reduce the number of deaths, and
if it does, the benefit is exceedingly modest.

Patients and their doctors are now faced with radically
polarized views about the logic of routine testing. On
one side are physicians like Mohler, who argue that the
test can reduce a man's chances of dying of prostate
cancer, plain and simple. This side of the debate is
passionate, backed by the persuasive conviction of men
who have survived prostate cancer and well financed by
the multibillion-dollar industry that has grown up
around the testing and treatment of the disease.

The other camp makes a less emotionally satisfying
argument: on balance, scientific studies do not support
the claim that screening healthy men saves lives.
Screening, Brawley and others argue, can lead healthy
men into a cascade of further testing and treatments
that end up injuring or even killing them. As Richard
Ablin, who discovered a prostate-specific antigen, put
it in an Op-Ed in The New York Times, using the P.S.A.
test to screen for cancer has been "a public health

So what should a man do when his doctor suggests a
routine P.S.A. test? The U.S. Preventive Services Task
Force, a panel of independent experts that evaluates the
latest scientific evidence on preventive tests and
treatments, is charged with making recommendations in
just such situations. It already recommends against
routine screening for men over 75. According to an
internal document, in 2009 the task force conducted an
in-depth analysis of data and seemed poised to give
routine P.S.A. testing a "D" rating - "D" as in don't do
it - for any man of any age. But this was around the
time that the task force stated that routine mammography
for women ages 40 to 50 was not necessary for every
woman. That recommendation caused a public uproar, and
the P.S.A. recommendation back for review. One year
later, in November 2010, just before midterm elections,
the task force was again set to review its
recommendation when Calonge canceled the meeting. He
says that word leaked out that if the November meeting
was held, it could jeopardize the task force's
financing. Kenneth Lin, the researcher who led the
years after its initial finding, it remains uncertain
when the task force will release its rating for P.S.A.

Cancer screening is a growing field; existing tests are
becoming more sensitive, and new tests are constantly
developed. We now have CT scanning for lung cancer, and
there is also a blood test marketed by Johnson & Johnson
known as a "liquid biopsy," which searches for stray
cancer cells in the bloodstream. More testing inevitably
brings more treatment, because the urge to correct every
cellular anomaly, no matter how small or potentially
harmless, is practically irresistible. But if there is
one lesson from the P.S.A. test, it is that more
information and intervention do not always lead to less

The popularity of the P.S.A. test as the main weapon
against prostate cancer is due in large measure to the
earnest and passionate advocacy of William Catalona, a
urologist from Northwestern University Feinberg School
of Medicine. During his residency training at Johns
Hopkins Hospital in the mid-1970s, Catalona set up a
clinic for late-stage prostate-cancer patients. Back
then, the only tool for finding prostate cancer was a
digital rectal exam - actually feeling the prostate
through the rectal wall. By the time many tumors could
be detected, the cancer was already advanced, and
removing the prostate surgically did not offer a
reliable cure.

Catalona grew close to many of the men he treated, as
well as to their families. "Prostate cancer is a
terrible death," he said. "They developed bone
fractures, they had a lot of pain, they lost weight.
They required heavy doses of narcotics."

Catalona wanted to catch these cancers early, when they
might be curable. He noticed that men with more advanced
cancers at the time of surgery tended to have the
highest P.S.A. levels. Could there be a bright line, a
"safe" level of P.S.A. that could distinguish healthy
men from those with prostate cancer? After reviewing his
own patient records, he decided the cutoff level should
be 4 nanograms of P.S.A. per milliliter of blood. He
followed up with a study of 1,653 patients. The results,
published in 1991 in The New England Journal of
Medicine, showed that P.S.A. testing could detect
prostate cancer several years earlier than a digital
rectal exam.

The test quickly gained powerful support: Gerald Murphy,
who held the position at the American Cancer Society now
held by Brawley, pushed the society to endorse the test.
In 1996, Gen. H. Norman Schwarzkopf, a prostate-cancer
survivor, appeared on the cover of Time magazine over
the statement "There's a simple blood test everyone
should know about."

By then, doctors were using the test for routine
screening. "P.S.A. testing was so easy," says H. Gilbert
Welch, a professor of medicine at the Dartmouth
Institute (full disclosure: one author of this article
is an instructor at Dartmouth). Doctors were predisposed
to use the test for several reasons. First and foremost,
there was the perception that early detection could save
lives. It was also easy to administer. "It was a blood
test," Welch says. "You didn't need equipment. . . . You
didn't need to put any scopes up any part of the body.
Heck, you didn't even need to ask the patient if he
wanted it; you could just check off the box on a list of
tests, like cholesterol, when you did a blood draw."
Today it's common for doctors to order the P.S.A. test
and patients to take it without talking about what it
might really mean.

At one time, Otis Brawley, too, assumed that routine
screening was the best medical practice. Sitting in his
living room in an Atlanta suburb, Brawley recounted his
transformation from believer to skeptic. In 1988, after
medical school at the University of Chicago, Brawley
landed a prestigious fellowship at the National Cancer
Institute in Bethesda, Md. There he came under the
tutelage of Barnett Kramer, an oncologist and
epidemiologist who went on to become the associate
director of the institute's early detection and
community oncology program. Kramer walked Brawley
through a short history of screening, beginning with the
Pap smear, which has been an unqualified success,
significantly cutting cervical-cancer deaths.

But other cancer screening tests had not worked out so
well. For example, researchers at the Mayo Lung Project
conducted a study between 1971 and 1983 to determine
whether frequent chest X-rays could help reduce deaths
from lung cancer. Chest X-rays detected lots of
suspicious spots and shadows on the lungs and probably
led to some cures of early lung cancers, but the study
ultimately found no difference in death rates between
the patients who were screened and those who were not.
Kramer suggested one probable explanation: diagnosing
the spots picked up by X-ray often requires surgery,
which carries a small but definite risk. Brawley knew
that many spots seen on X-rays are simply old scars or
minor abnormalities commonly seen in healthy people.
With so many innocent blips detected, complications from
lung biopsies and other invasive tests, along with
treatment complications, could kill enough patients to
negate any benefit from early detection.

Prostate cancer is the second-leading cause of cancer
death among men, after lung cancer. In 2009, it was
diagnosed in approximately 192,000 men. A small number
of tumors are very aggressive, but the majority of
prostate tumors are not likely to cause death. They grow
very slowly, and only a fraction break out of the
prostate, seed new tumors in other parts of the body and
kill the patient. The current thinking is that about 30
percent of men in their 40s have prostate cancer, 40
percent of men in their 50s and so on, right up to 70
percent of men in their 80s. Yet only 3 percent of all
men die from the disease. In other words, far more men
die with prostate cancer than from it, and only a tiny
fraction of prostate cancers ever cause symptoms, much
less death.

But here is the tricky part: Unless there are symptoms
or a finding on a physical exam, doctors generally
cannot accurately predict which cancers are destined to
be indolent, to sit around for years growing slowly, if
at all, and those that will ultimately prove lethal.

In his discussions with Kramer, Brawley saw that these
two pieces of information - the fact that a certain
number of prostate cancers will never cause harm, and
that doctors can't reliably predict which cancers will
be dangerous - had powerful and potentially devastating
consequences for men. The first implication was that
using the P.S.A. test to screen men who had no symptoms
would uncover a huge reservoir of indolent cancers. Most
of those cancers that men previously died with - and not
from - would now theoretically be detectable. And once
detected, the majority of those cancers would be

The most frequent treatment then, as it is now, was the
surgical removal of the entire prostate gland. The
prostate sits at the base of the penis, wrapped around
the urethra, which is the tube that carries urine and
semen out of the penis. Trying to separate gland from
urethra is a difficult job, and even the best of
surgeons can damage the urethra or the bundle of nerves
that initiate erections. About half of men who undergo
radiation or surgery will have permanent side effects
like impotence and incontinence. Up to 1 in 200 men die
within 30 days from complications related to the

"You didn't have to be brilliant to see that history was
repeating itself," Brawley says. "Doctors were just
substituting a blood test for chest X-rays."

Tim Glynn, a self-described country lawyer from
Setauket, N.Y., was 47 in 1997 when he went to his
primary-care doctor, troubled by a vague feeling of
being down. After his physical exam, Glynn was sent to
have his blood drawn. Along with thyroid and cholesterol
levels, the doctor ordered a P.S.A. test. A week later,
Glynn returned to hear the results. His P.S.A. was
elevated. He was told to get a biopsy as soon as

After the biopsy, he walked into a bar in the middle of
the afternoon and ordered a martini. A few weeks later,
Glynn's urologist told him the biopsy showed prostate
cancer and recommended that he have his prostate removed
immediately. Glynn chose to do some homework first.

One of Glynn's clients happened to be Richard Ablin, the
scientist. Ablin told him that not all prostate cancers
are alike, and that he could wait; if he developed
symptoms, or if his P.S.A. shot up, he could always opt
to be treated at that time. (Some doctors recommend
"active surveillance," in which the patient is
periodically given P.S.A. testing and biopsies, rather
than immediate treatment.) Glynn chose to hold off on

Kerri Glynn, Tim's wife of now 39 years, was terrified
by her husband's decision. "I felt as if an ax had
fallen," she says. In her mind it was better to be safe
than sorry, and safe meant being treated immediately.
"She was a wreck," Glynn says. "She was scared witless."

His colleagues were also worried about his decision to
forgo treatment. "My business partner was clearly very
anxious, and my assistant asked if she should look for a
new job," Glynn recalls. "And there was the fear that if
this became public knowledge, there would be clients who
wouldn't want to deal with us because they wouldn't want
to engage a lawyer who was going to be dead the next
day. When you see the people around you falling apart,
you sort of have to get treated for them, so you can go
back to a normal life."

For many people, not being treated after a diagnosis of
cancer is psychologically unbearable. Our view of
cancer, says Barnett Kramer, is still shaped by the fact
that until relatively recently, cancers were only
discovered when they were causing symptoms. Before
current treatments were available, such cancers were
often fatal. We can now screen for cancers long before
they become symptomatic, but it's still very difficult
to imagine that they can safely be left untreated.
Brawley says, "I have had patients say, `Damn it, I'm an
American - you can't tell me I have cancer and we're
going to watch - you have to treat it.' "

Glynn had the surgery. Fourteen years later, he still
takes drugs for impotence. It would be more than a year
following surgery before he had the energy to play a set
of tennis again. "The toll that this took on energy and
physicality was like being aged five years," he says.

One way to look at Glynn's story is as a success. His
cancer was removed. His impotence is being managed. But
Glynn sees it differently, and so do many other men who
have been treated for prostate cancer. Darryl Mitteldorf
is the executive director of Malecare, a cancer-patient
support group. He says it is not uncommon for men to
regret their decision to be tested and treated for
prostate cancer. "We have men come in very upset, week
after week, telling us what they're not telling their
doctors," he says. One-third of men who are given a
P.S.A. test were never asked if they wanted it. Of men
who are asked, more than half say their doctor failed to
mention possible side effects that result from

Brawley tells the story of a patient who had surgery and
then underwent radiation, which left him with severe
damage to both his rectum and ureter. "He had every side
effect known to man," Brawley says. "He had a bag for
urine, a bag for stool, he was a terrible mess, in and
out of the hospital with infections." The man died six
years after his surgery, from an overwhelming infection.
Yet cancer statistics would list such a man as a success
story, Brawley says, "because he survived past the five-
year mark." Would an untreated prostate cancer have
killed him within six years, too? There is simply no way
to know.

Many doctors suggest that African-American men and those
with a family history should be tested as early as age
40, because they are at increased risk of dying of
prostate cancer. But Brawley, who is African-American
and has declined P.S.A. screening himself, says this
recommendation is based on conjecture, and even for men
at higher risk, the test may cause more harm than good.
Until the proper studies are done, he asserts, "We just
don't know."

The dueling narratives of P.S.A. testing boil down to
the way each side frames the potential for harm from the
disease compared with the collateral damage from the
test and subsequent treatment. Mohler says, "P.S.A.,
when used intelligently to detect prostate cancer early
in men after proper education . . . performs pretty
well; it actually performs better than a mammogram."
P.S.A. advocates are concerned that statistics play down
the value of each life saved. Some also argue that the
statistics will validate their view as men are followed
beyond 14 years. More important, they worry that if men
reject screening, malignant cancers will go undiagnosed.

David Newman, a director of clinical research at Mount
Sinai School of Medicine in Manhattan, looks at it
differently and offers a metaphor to illustrate the
conundrum posed by P.S.A. screening.

"Imagine you are one of 100 men in a room," he says.
"Seventeen of you will be diagnosed with prostate
cancer, and three are destined to die from it. But
nobody knows which ones." Now imagine there is a man
wearing a white coat on the other side of the door. In
his hand are 17 pills, one of which will save the life
of one of the men with prostate cancer. "You'd probably
want to invite him into the room to deliver the pill,
wouldn't you?" Newman says.

Statistics for the effects of P.S.A. testing are often
represented this way - only in terms of possible
benefit. But Newman says that to completely convey the
P.S.A. screening story, you have to extend the metaphor.
After handing out the pills, the man in the white coat
randomly shoots one of the 17 men dead. Then he shoots
10 more in the groin, leaving them impotent or

Newman pauses. "Now would you open that door?" He argues
that the only way to measure any screening test or
treatment accurately is to examine overall mortality.
That means researchers must look not just at the number
of deaths from the disease but also at the number of
deaths caused by treatment.

Many experts agree with Newman, and two large studies of
P.S.A. screening, published in The New England Journal
of Medicine in 2009, came to the same conclusion: There
was no difference between the screened and unscreened
groups in overall deaths. One trial, conducted in the
United States, showed no reduction in prostate-cancer
deaths over a period of up to 10 years when men 55 and
older were screened. The other, which was carried out in
several European countries, showed that screening
reduced mortality from prostate cancer by 20 percent,
yet the overall number of deaths in each group was the
same. Newman gives one possible reason for this: the
benefit of early diagnosis could be offset by
complications from diagnostic tests and subsequent

Each study has been criticized for design and execution
issues that might have skewed the results, but the
failure to reduce overall mortality reported in the
European study is probably no fluke, Newman says. An
analysis of six studies of screening involving nearly
400,000 men, published last year in the British medical
journal BMJ, found no significant difference in overall
mortality when screened men were compared with controls.
Philipp Dahm, a professor of urology at the University
of Florida College of Medicine and lead investigator for
the analysis, says the study shows that P.S.A. screening
"does not have a clinically important impact" on overall
mortality. Or as Kramer, an author of the U.S. study,
crisply puts it, "Men may be trading one cause of death
for another."

For Brawley, the greatest tragedy of P.S.A. screening is
that it has been a distraction from making greater
progress in reducing deaths with the one clear helpful
thing: distinguishing between the prostate tumors that
really need to come out and those that are better left
alone. Instead, new types of P.S.A. screening are being
promoted. "We live in a time when our failure to define
questions properly has delayed our progress and harmed
health," he says. "We keep pursuing son of, son of

As it stands, each man must decide for himself how he
wants to play the odds. "Let's put this in perspective,"
says Welch, whose most recent book is "Overdiagnosed:
Making People Sick in the Pursuit of Health." "The
European trial says 50 men have to be treated for a
cancer that was never going to bother them to reduce one
death. Fifty men. That's huge. To me, prostate screening
feels like an incredibly bad deal."

Other men, Welch acknowledges, may arrive at a different
conclusion, and he is careful to avoid pushing his own
patients in one direction or the other. The answer is
ultimately personal, he says, and while studies of
groups of people can feel unhelpful if you could be the
one in the group with cancer, that is all we have to go

The solution, in Welch's view, and in that of a growing
number of physicians, including Brawley, is to make sure
men fully grasp the downstream decisions they may face
as a result of screening - the risk of knowing too much.
Studies have found that when men are given balanced
information about both the cons and pros of P.S.A.
testing, they are less likely to opt for screening than
men who were merely offered the test. Given this,
Brawley asks, how can it be ethical for a doctor not to
inform men of the risks - or to fail to even tell a man
that the test has been ordered? "If a man understands
the risks and benefits and does not want to be screened,
that decision should be supported," he says. "But just
saying that gets you in trouble."

Shannon Brownlee ([log in to unmask]) is acting
director of the New America Foundation Health Policy
Program and an instructor at Dartmouth Institute for
Health Policy and Clinical Practice.

Jeanne Lenzer ([log in to unmask]) is a freelance
journalist and a frequent contributor to the British
medical journal BMJ.

Editor: Vera Titunik ([log in to unmask])


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