How We Do Harm (31 page)

Ralph is emotionally crushed and worried he might still have cancer.
Now he really wants radiation therapy to the pelvis to kill all the cancer and rid his body of the problem once and for all.

Salgado is reluctant to irradiate immediately.
He orders a CT scan of the pelvis and looks for any evidence of prostate cancer.
He performs a ProstaScint scan and finds some PSA uptake in the pelvis.
The scan is hard and uncomfortable for Ralph, as he has to stay still for quite a while.
Salgado sees a “shadow” there.
This could be a residual piece of the prostate.
But the test results aren’t so bad.
There is no sign of disease in the bone, nothing in the lymph nodes.

Ralph is emotionally out of control, growing more and more anxious, reaching the boiling point.
Salgado senses his patient’s anxiety and frustration and suggests something else to consider: salvage radiation therapy to the pelvis.
He doesn’t try to sell the treatment, just mentions it as a possibility.
He describes this as a shotgun blast to the pelvis in the hopes of killing the cancer that may be there.
In technical terms, Ralph would get a radiation dose of 7,000 cGy (cGy is the abbreviation for centigray, which is a unit of radiation energy absorbed) to the prostatic fossa, the area of the pelvis where the prostate used to be.

Ralph likes this.
He just can’t contemplate that he might have cancer and that it is not being treated.
He wants radiation therapy to start immediately.

Salgado tells Ralph that radiation can have significant side effects, and that success is uncertain.
Ralph wants radiation and he gets it.
About six months after surgery, Salgado starts daily therapy, Monday through Friday, for six weeks.
Ralph continues to have impotence and incontinence.
Four weeks into the radiation, Ralph sees blood in his stools.
This is due to radiation proctitis, radiation damage to the rectum.
He continues having incontinence, but also develops a burning sensation upon urination.
These symptoms exasperate Ralph.
He has growing anxiety and fear.
He is depressed.

Ralph ends up stopping his radiation with one week to go.
For rectal proctitis he goes to a gastroenterologist, who prescribes steroids in a rectal foam that Ralph has to put up his rectum four times a day.

About three weeks after stopping the radiation, Ralph realizes that when he passes gas, some of it comes out of his urethra.
He also senses liquid from his rectum soiling his diaper.
Drs.
Salgado and Barrish both confirm the diagnosis: Ralph has a rectal fistula into the bladder.
There is a hole between Ralph’s rectum and his bladder.

After several urinary infections, when the fistula doesn’t seem to be healing, Ralph has to see a GI surgeon.
He performs a colostomy to keep stool off the inflamed rectum and the hole into the bladder.
The next step will be a ureterostomy, a surgery that will bring urine to his abdominal wall and collect it in a bag, just like his bowel movements.

Chapter 21

Behind the Blue Curtain

RALPH CALLS ME
one day in 2005.
He leaves a message with an administrative assistant that he wants to talk about prostate-cancer screening and treatment.
He says he had seen my name in the press and has some questions.
I get several calls a week from patients who have questions about prostate-cancer screening.
They seek me out because I am an often-quoted, outspoken skeptic.

I view it as part of my mission in life to return every one of these calls.

Ralph says he has read my interview in the online publication PSA Rising, and it’s the first time that he has heard that the effectiveness of screening for prostate cancer and its treatment has been questioned.
I explain that there is significant controversy, and that I worry that men aren’t informed about what is known, what is not known, and what is believed.
Ralph asks me to go on.

I tell him that most major organizations that have made statements about prostate-cancer screening have either said they don’t recommend it, as it is not proven to save lives, or recommend that men be told of the known and proven harms and the possible benefits before being screened.

Often, people who had been diagnosed through screening believe that their lives have been saved and are grateful to the doctors who have, in fact, harmed them.
Ralph seems to be different.
Something remarkable is in his voice.
He sounds vulnerable, sincere, open to self-examination.
During our first conversation, he notes that I have already given him more time than the doctors he paid for advice.

After Ralph tells me his story, I tell him that I should be the one getting billed for our conversation.
He laughs.
But I am dead serious.
I learn a lot every time I talk with a patient who is ready to question the system.
Ralph and I end up having at least forty conversations over the following five years.

In our first chat, I explain that ever since screening for prostate cancer was first suggested, prostate-cancer experts have been debating its efficacy.
Willet Whitmore, a famous urologist who died of the disease, summarized the quandary this way: “When cure is possible, is it necessary, and when cure is necessary, is it possible?”

Another famous and wise urologist, Paul Schellhammer, who, ironically, also has the disease, said that two kinds of prostate cancer definitely exist, and we hope there are three: “There is the kind of prostate cancer that can be cured, but does not need to be cured; there is the kind of prostate cancer that needs to be cured and cannot be.
We all hope there is a kind of prostate cancer that needs to be cured and can be cured.”

Treatment can have severe side effects, and we desperately need to find a test that distinguishes a cancer that needs treatment from a cancer that needs observation.

*

I
tell Ralph about a clinical trial I helped design, the Prostate Cancer Prevention Trial (PCPT).
The trial was intended to determine whether the drug finasteride has the potential to prevent prostate cancer.
It’s an interesting question (the answer is yes, sort of), but to me, the most important finding came from follow-up of the group of men who got the placebo.

These were men at average risk of prostate cancer.
Until that trial, no one knew how prevalent the disease is in average-risk guys, how likely it is to be detected through PSA, and what the risk of death would be.
Us TOO, the urologists, and the Prostate Cancer Coalition thought they knew the answer: “PSA saves lives.”

PCPT gave us a very different answer.
It told us that the majority of prostate cancers found through screening fall into the category of not needing to be cured if left alone.
In that trial, men of median age of sixty-two with a PSA of less than 3.0 were consented and randomized to receive seven years of finasteride or a placebo.

Both groups were screened with PSA annually for seven years, and an abnormal screen led to a biopsy of the prostate.
At the end of seven years of screening, those with all normal screens (eight total screens) were biopsied anyway.

The study showed that 14 percent of men in the placebo arm were diagnosed with prostate cancer through screening, and another 14 percent of men in the placebo arm who had seven years of normal screening results were diagnosed with prostate cancer by biopsy.
So, PSA screening missed as many cancers as it found.

When the trial began, proponents of screening blasted it, arguing that enrolling men with PSAs of 3.0 or less was trying to prevent prostate cancer in men at low risk for the disease.
Yet, the study found that 28 percent of these purportedly low-risk men did indeed have prostate cancer.

I have a friend, Rocky Feuer, who became famous for developing a computer program that uses cancer and population data to estimate risk in a population.
His most famous work resulted in the phrase “one in seven women will be diagnosed with breast cancer.”

If you plug prostate mortality data into Rocky’s program, you come up with the prediction that one in thirty-three men, or 3 percent, will die of prostate cancer.
In other words, if a screening practice diagnoses 28 percent of men with prostate cancer when we know that only 3 percent of these men will die of their disease, it’s pretty obvious that we are overdiagnosing and overtreating.

“So why is screening so popular?”
Ralph asks.

“Many people have been told ever since they were on their mother’s knee that finding cancer early and cutting it out is the best therapy for cancer,” I say.
“I was taught in high school that wise men question what they learn on Mother’s knee, and most men are not wise.”

People think screening is beneficial, which it can be—for some cancers, in some populations—but not uniformly.
For prostate cancer, some large trials are under way to find out if screening is beneficial, but those trials have not been completed.
I tell Ralph that I am not convinced that they will be completed.

He asks why I am so pessimistic.
I tell him the truth.
So many people have decided that screening is beneficial and encourage it that the American trial designed to measure the PSA test’s impact on mortality has been hard to accrue to and hard to run.
You can perform a clinical trial—or take part in it—only when you don’t know the answers.
In this instance, too many men and too many of their doctors believe that they know the answers.

Some men who would be candidates for the study are so upset about prostate cancer that they want to do something.
They say it’s better to do something—even if it doesn’t work—than to let men die of prostate cancer.
These well-meaning folks don’t understand that screening can be harmful by leading to anxiety and mental anguish over abnormal findings.

Screening can lead to unnecessary treatment that can have its own terrible side effects.
These things are proven, whereas the health benefit of screening is only theoretically possible.

The financial benefits of screening for a long chain of medical businesses have been measured almost to a penny.
This is a game with a predetermined outcome: everyone but the patient wins.

I tell Ralph about a conversation I had with a marketing guy at a major American cancer center.
He explained that they ran free screenings at a local mall every September as part of Prostate Cancer Awareness Month.
As I struggled to control my anger, this gentleman explained the business formula:

“First, free screening provides free good publicity for the health system.
People really feel good about us, because this is a community service.
It will cause women to come to our women’s center and men to come to our chest-pain center.
It increases almost all our product lines.
It’s cheap, effective advertising.

“For every thousand men over age fifty who volunteer for free screenings, one hundred and forty-five will have an abnormal screen.
Given the demography of the mall, ten of the one hundred and forty-five will have insurance that our health system doesn’t take.
So, one hundred and thirty-five will come to us to see why they have an abnormal screen.
We make up the cost of offering free screening by charging for evaluation of the abnormal screens.
About forty to forty-five will have cancer.
We hit bingo with them.
We know the number who will get radical prostatectomy, the number who will get radiation therapy, the number who will get hormones.

“We know the number who will have incontinence so bad that they will want an artificial urethral sphincter implanted.
We even know the number who will not be able to get erections and will want Viagra.
We know for how many Viagra won’t work.
We know how many penile prostheses we will sell.”

Realizing that I have been granted an audience with Lucifer, I asked the fundamental question: “How many lives will you save if you screen a thousand men?”

The marketer took his glasses off and looked at me as if I were a fool.
“Don’t you know, no one knows if this stuff saves lives?
I can’t give you a number on that.”

Ralph is shocked.
“You mean it’s a big business?”

“Yes,” I say.
“Unfortunately, it’s a big business that’s easy to get into because of the prejudice that screening must be beneficial.
Consumers—and even many doctors—just don’t understand the science and why screening can be a very bad thing.
Some choose to stay uninformed.
Many actually believe in screening and have no doubts—contrary to the science.
Screening is like a religion to them.
They believe it—they get screened themselves.
If they thought it was purely a scam, they wouldn’t get screened.”

In one study, 80 percent of male urologists over age fifty reported having chosen to get screened.
The same study shows that 50 percent of male internal medicine specialists get prostate-cancer screening.
It seems that most urologists have come to believe their own stories, while internists are more skeptical.

Ralph and I start talking about the scam.
He asks good questions and I answer bluntly.
As a result of our conversations, Ralph ends up understanding prostate cancer and prostate-cancer screening better than most physicians.

We talk about other screening disasters.
I tell him about lung-cancer screening with chest X-rays.
A number of organizations encouraged it because it found disease at an earlier, more treatable stage.
These organizations used false logic to justify screening.
This led to increased survival times among those who got screen-detected and still died of lung cancer.
These endorsements actually discouraged the completion of the randomized prospective trials that showed that chest X-ray screening at best did not save lives and may well have increased risk of death.

“Those who cannot remember the past are condemned to repeat it,” I say, quoting George Santayana.

Ralph asks me about the guys at Us TOO, the pro-screening patient group he first encountered at the health fair.
I am well aware of that group and the information it provides.
(They know me, too.
Hank Porterfield, a leader of Us TOO in the 1990s, had nicknamed me the Prince of Darkness.)

Most of these organizations see the cancer problem as being much simpler than it is and push prostate-cancer research without knowing anything about good research.
They tend to gather and relish in the brotherhood and commonality of having cancer.
Support is important.
I am sure some well-meaning people can be found in these groups, but most just don’t get it.