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It's Time For Medicine To Make Quality Job #1

by Dr. Len March 30, 2009

At first glance, a scientific paper presented at the 58th Annual Scientific Meeting of the American College of Cardiology in Orlando on Saturday is reasonably straightforward.  Dig a bit deeper, and the presentation highlights some of the serious issues facing us as we try to reconstruct our health care non-system here in the United States.


At heart (pardon the pun), the paper is reasonably straight forward: cancer specialists use drugs that can damage the heart.  What the researchers found is that those same specialists don’t do as well as they could when it comes to detecting and treating heart failure in those same cancer survivors who have received those same drugs.


The larger question is what are we going to do to address this issue and the quality of  all medical care we deliver and receive, when we don't have the strong commitment and the systems in place to get the job done?  Maybe it's time for the doctors in this country to step up to the plate, admit we have a systematic problem, and commit to getting the job done.


The authors examined the records of patients treated with cancer chemotherapy drugs known to have heart failure as a significant side effect.  The patients were treated at a major, highly regarded university hospital from October, 2005 through October 2007.  13% of the patients had a poorly functioning heart before they ever got the medicines, and 41% had their heart function decline either during or after they were treated.


Of the patients who either had or who developed heart failure during their treatment (75% of the patients with heart failure had no symptoms), less than half received medicines recommended for treating heart failure.  Only 37% were seen by a heart specialist.


One of the authors of the study commented, “Most oncology trials that look at (heart failure)…pay very little attention to asymptomatic (heart failure).  This is something that cardiologists, and certainly heart failure specialists, take extremely seriously.”  Another author commented that patients need to be aware of the side effects of the drugs, and that doctors need to better screen patients for these known complications of treatment.


We have known for years, ever since some of these drugs were introduced into cancer treatment, that certain medicines can cause heart failure when used as intended to treat cancer.  The first one that I am aware of that was recognized to cause this serious complication was adriamycin, which has proven to be a key drug in the treatment of several cancers since it was first introduced to researchers and then more widely used in the late 1960’s and early 1970’s.


We knew the drug was dangerous, and we began limiting the dose.  We knew the drug could cause heart failure, and were alert to the symptoms.  We used echocardiograms—which is a straightforward, non-invasive way to monitor heart function—routinely. 


Despite all of our knowledge, patients still developed heart failure.  Some have even developed heart failure years after completing the drug.


Now there are more drugs that are known to have the same complication.  Perhaps the best known is Herceptin, or trastuzumab, which is used to treat advanced breast cancer as well as a preventive treatment after primary surgery, radiation and standard chemotherapy in women who have a particular genetic abnormality in their tumors (called HER2).


So it’s not that doctors don’t know about these risks. They do.  But the new research implies they aren’t doing all they should be doing to evaluate and treat patients who develop congestive heart failure, especially if no symptoms are present.


And that to me is the larger message and implication of this paper: how do we create a process of care that helps medical professionals, patients and their families easily and effectively understand the risks they face from their treatments, and that they get the right follow-up care at the right time to detect and treat those complications?


This is by no means a problem unique to oncology.  Similar problems with treating patients following heart attacks and those with congestive heart failure have been known for years.  Those issues were in fact used as some of the first quality indicators in rudimentary efforts to measure quality medical care.


I can tell you that if you asked a room full of doctors if they do what they are supposed to do for their patients, every one would raise their hands.  But studies such as this one show is that even the most well-meaning physician—and I do believe that most medical professionals are sincere in their beliefs that they put their patients’ care and interests first—still don’t do all the things they need to do for their patients.


The message, therefore, is that we need to develop systems of care that enhance the quality of medical practice in the United States.  We need to do it in a way that is pro-active, non-punitive and gets the job done.  Unfortunately, we remain far from that goal as I write this despite efforts underway to address these concerns.


I also believe that we as a medical profession have to take the first step in admitting that we could do better.  Imagine how far that would take us in the eyes of our patients: saying that we understand we could do better, then develop the systems that enable us to do better, and hold ourselves accountable to our patients to demonstrate that in fact we are doing better.


It is my personal opinion—and has been for many years—that if we as doctors took charge of the “quality paradigm,” our image and our reputations would increase dramatically.


The other part of this equation, especially for cancer patients and their families, is to give them the information they need so they understand what needs to be done as they transition from active cancer patient to long term survivor.


We can’t lose sight of the fact that we have grown from a nation of 3 million cancer survivors in the early 1970’s to over 12 million cancer survivors today.  And, in the future, as our country gets older and we see the number of cancer patients increase, we will have even millions more survivors to care for in an overtaxed medical system.


We need tools and information to allow everyone—primary care professionals, oncologists, nurses, patients, families—to have the information they need in real time to help understand the next steps in their care.


That to me is the goal we should target.  It’s not just about making care more accessible or more affordable.  Those are certainly important goals.  But it is also about making care more effective in a process that is built on partnership, trust, and accountability through the use of information technologies and resources that are available to us right now, if we only took the time to develop them further and take advantage of them.


And let’s not leave out the need for more research like this current report, which helps us understand better the long-term consequences of our treatments and what we need to do to address the gaps that inevitably will be discovered in the future.


As a physician, I frequently hear about the incredible safety record of airlines and pilots (for which I am personally very grateful, since I fly a lot) and how we need to take some of that learning and attitude and apply it to medicine.  And then I hear from the doctors that medicine is an art as much as a science, and that we shouldn’t have to practice “cookbook medicine” accordingly to some impersonal guideline that doesn’t apply to “my patient.”


Well, I think we need more of the science while we maintain the art and the sensitivity of our care (which unfortunately may be disappearing as we continue to fractionate our health care delivery).  We need to “seize the day” and commit ourselves to quality care.  We need to develop information systems that work, both for providing information when needed to those who need it, and monitor the outcomes and adherence to the recommendations.  And, of course, we need to do this in the context of being able to provide access to affordable, effective health care.


I know it’s a tall order.  I have been hoping that we would embrace this approach ever since I was a much younger medical student.  I still maintain that every day we can do better.  That thought remains very much alive for me, and perhaps for you as well.


When it comes to improving our health, we should never give up that hope.

Filed Under:

Cancer Care | Medications | Treatment

Screening For Prostate Cancer: Jury Still Out

by Dr. Len March 18, 2009

Have you ever wanted something for such a long time that when it finally arrived you found yourself terribly disappointed? 


Maybe that’s the best way I can summarize my feelings about two studies reported today in the New England Journal of Medicine on the topic of prostate cancer screening and whether or not it really makes a difference.


For years we have been saying that there wasn’t sufficient evidence to prove that screening for prostate cancer saved lives.  That was almost always followed by a statement that we were waiting for the results of two trials in the United States and Europe.  “They will show us the answer” we said. In the meantime, millions of men continued to get tested and undergo treatment, even though no one could really say if we were saving lives, or just sending millions more men to unnecessary treatment with all sorts of side effects.


Well, my friends, the waiting is over.  The day has arrived.  And I don’t know that we now have any better idea whether or not prostate cancer screening actually works. 


Prostate cancer in the United States in 2008 was estimated to occur in 186,320 men (we haven’t made our 2009 estimates yet, due to a delay in getting 2006 mortality data from the Centers for Disease Control (CDC), in part because of budget cutbacks.  But that is a story for another day.)  The American Cancer Society estimated that 28,660 men would die from prostate cancer in the United States in 2008.  Prostate cancer is the most common  cancer in men, accounting for 25% of cancers diagnosed in men in 2008.  It is the second leading cause of cancer death in men—behind lung cancer—accounting for 10% of cancer deaths.  A man in this country has a 1 in 6 chance of being diagnosed with prostate cancer during his lifetime, with most of those diagnoses occurring at ages 70 and older. Importantly, and not mentioned as often, is the fact that only one in 34 men will die of the disease.


The two research papers in the New England Journal of Medicine describe early results from two different trials—one in the United States and one in Europe—which were designed to find out whether or not tests to find prostate cancer early reduced deaths in men from the disease.


In the United States trial, 76,693 men between the ages of 55 and 74 years were randomly assigned to be screened or receive “usual care” from 1993 to 2001.  The men in the screened group had annual PSA testing for 6 years and digital rectal examinations every year for 4 years. 


The good news is that the men in this trial who were in the screened group did a reasonably good job of following the directions of the trial: 85% of them had their PSA blood test and 86% did the rectal exam as requested. 


The not so good news is that by the sixth year of the trial, 52% of the men in the control group—who were left to their own devices as to whether or not they should get the PSA blood test—had the test.  46% of these men had a rectal exam.


What that leaves us with is a clinical trial where the men who were asked to get screened did get screened.  And of the men who were not told to get screened, about half of them got screened anyway. 


The end result was that after 7 years of follow-up (the follow-up ranged from 7.2 to 14.8 years, with half of the men followed for 11.5 years or more), there were more cancers diagnosed in the screened group (no surprise there: go looking for prostate cancer in a man and you have a pretty good chance of finding it) compared to the “control group,” but the deaths were a bit higher in the screened group compared to the supposed no-screening group (although these numbers were not significantly different).


The conclusion? “After 7-10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups.”


The authors acknowledged some limitations in their study, including the fact that treatment for prostate cancer may have improved so much as to negate any benefit that screening may have had.  They also point out that it may yet be too early to draw a definite answer from the study, and that further follow-up of the men participating in this study may be warranted:


“Risks incurred by screening, diagnosis and resulting treatment of prostate cancer are both substantial and well documented in the literature. To the extent that overdiagnosis occurs with prostate cancer screening, many of these risks occur in men in whom prostate cancer would not have been detected in their lifetime had it not been for screening.  The effect of screening on quality of life is a subject of an ongoing substudy and should be completed within the next several years.  Follow-up in the PLCO trial (the name of this study) is planned to continue until all subjects reach at least 13 years.  A final report will be presented once the planned duration of follow-up is completed.”


What about the European trial? That one is even a bit more confusing to understand.


182,000 men between the ages of 50 and 74 in seven European countries were randomly assigned to get a PSA test “at an average of once every 4 years” or to a control group that did not get screened.  Of this group, 162,387 were actually part of the current report, and these men were between the ages of 55 and 69 years.


Half the men were followed for more than 9 years, and half less than 9 years.  82% of the men who were offered screening got at least one PSA test.  Of those who had at least one PSA test, 8.2% were diagnosed with prostate cancer, and of those who did not have the test, 4.8% had a diagnosis of prostate cancer made during the period of the study.


The end result was that the risk of death in the men who were screened was 20% less than those who were not screened.  In more plain terms, according to the authors, “1410 men would need to be screened and 48 additional cases of prostate cancer would need to be treated to prevent one death from prostate cancer.”


When one considers all of the problems (urine incontinence, impotence, pain and bleeding among others) associated with treatment for prostate cancer, that is a lot of men left with a lot of symptoms to save one life.


In this study, the authors concluded, “PSA-based screening reduced the rate of death from prostate cancer by 20% but was associated with a high risk of overdiagnosis.” 


When you dig deeper into the study, you begin to see some inconsistencies that may have influenced the results. 


Recruitment and randomization procedures were not the same in every country that participated.  Portugal stopped participating, and France joined late.  All countries included men ages 55-69, but Sweden also included men who were 50-54.  The Netherlands, Italy, Belgium and Spain included men up to the age of 74, and in Switzerland men were screened up to the age of 75.  In all countries except Finland, men were randomly assigned on a “50-50” chance basis to screening or no screening.  Finland decided to screen 2 men for every one in the control group.


Some other interesting tidbits:  In the United States trial, men had to have a PSA level of 4 or more before being referred for further diagnostic studies.  In the European trial, the PSA level that triggered diagnostic studies was 3.  The result is that fewer men would be diagnosed in the US, while more men would be diagnosed in Europe.  But, the rate of overdiagnosis in the European trial was likely greater, and the possibility exists that there was underdiagnosis in the US.


Here is another interesting piece of information:  In the European trial, 75.9% of the men who underwent prostate biopsy because of a PSA of 3 or greater did NOT have prostate cancer.


The conclusion of this study?


“Although the results of our trial indicate a reduction in prostate-cancer mortality associated with PSA screening, the introduction of population based screening must take in to account population coverage, overdiagnosis, overtreatment, quality of life, cost and cost-effectiveness.  The ratio of benefits to risks that is achievable with more frequently screening or a lower PSA threshold than we used remains unknown.  Further analyses are needed to determine the optimal screening interval in consideration of the PA value at the first screening and of previously negative results on biopsy.”


Sounds like a draw to me.


There was an editorial that accompanied these two articles, which reported that—in the mode of “do as I do”—95% of male urologists and 78% of primary care physicians who are age 50 or over have had their own PSA tested.  The author also noted that there has been a significant decline in deaths from prostate cancer since the early 1990’s.


The editorialist goes on to say:

“Neither set of findings seems definitive; that is, there was neither a clear declaration of futility in the PLCO trial (United States) nor an unambiguous net benefit in the ERSPC (European) trial.  Both studies are ongoing, with future updates promised…(The) decisions to publish now can be criticized as premature, leaving clinicians and patients to deal with the ambiguity…


“The implications of the trade-offs reflected in these data, like beauty, will be in the eye of the beholder.  Some well-informed clinical and patients will still see these trade-offs as favorable; others will see them as unfavorable.  As a result, a shared decision-making approach to PSA screening, as recommended by most guidelines, seems more appropriate than ever.”


Shared decision making about getting a PSA test and digital rectal examination for the early detection of prostate cancer is exactly what the American Cancer Society recommends.  You need to talk about prostate cancer screening with your doctor or other health care professional. You need to know the risks, benefits and harms that can occur as a result of screening for prostate cancer before you embark on getting these tests as part of your routine medical care. 


What is the impact of these reports? 


Unfortunately, now armed with the knowledge I have been waiting for, I am completely underwhelmed. 


Our recommendation regarding prostate cancer screening is no different now than what the Society has been saying for years.  Men need to talk with their health care professionals about the test.


The only difference now is that the long awaited studies have been reported.  And our message hasn’t changed.


Maybe more men will give some thought as to whether or not they really want or need a PSA test and rectal examination.  I don’t think that is a bad thing.


I suspect the “gung-ho go forward at any cost” attitude of those in the medical and advocacy communities who have promoted prostate cancer screening with a vengeance—absent evidence that it really saved lives—is going to calm down just a bit. 


At first blush, my reaction was that these studies don’t really give us the answer we were waiting for.  But on further reflection, maybe they did—sort of like not making a decision is in fact a decision. Perhaps not getting a clear answer to the question as to the value of prostate cancer screening is in fact a clear answer. 


At the end of the day, each of us will have to be our own judge on the merits of the case and what we want to do for ourselves when it comes to the early detection of prostate cancer.

Setting The Record Straight About Cancer Screening

by Dr. Len March 12, 2009

This must be the week for cancer screening stories and reports, some of which are clearly crafted to alarm people who read them or watch them.  A segment on this morning’s NBC Today Show is a case in point, along with the original story on the Reader's Digest website which served as the basis for the TV segment. A report earlier this week about the “over diagnosis” of prostate cancer as a result of screening was another.


What was missing from these various presentations and reports is a sense of balance about who has said what, which organization has made what recommendation, and an honest commentary that is meant to inform rather than frighten.


When I read the original article and watched the video of this morning’s segment, I began to wonder how many people who viewed that information came away truly informed about the issues, the science and the facts (Matt Lauer’s concerns notwithstanding).


Let me make something perfectly clear: comments that screening for cancer isn’t the answer to reducing deaths from every cancer are not new.  Also untrue is the implication that those of us who advocate screening for certain cancers aren’t aware of the risks of screening. 


We have always known that there are a variety of ways that cancers behave in our bodies.  We have known for decades that there are cancers found on autopsy studies or incidentally through other means that never caused anyone any problem.  The classic examples I learned about in medical school over 30 years ago included thyroid cancer, breast cancer and prostate cancer.


Now, with our improved abilities to search our bodies with advanced imaging techniques such as ultrasound, CT scans, and MRI scans, we are indeed finding more and more cancers that fit the definition of an “indolent” cancer. 


To say that we are not aware of the variability of the natural history of cancer, or the fact that we will pick up cancers that would never cause a problem, or that there may be harms from the biopsies and treatment for cancer is a misrepresentation of what we know and what we do when it comes to recommendations for cancer screening.  We think about those issues every day, at least here at the American Cancer Society.  We talk about them, we argue about them, we write about them.


Yes, we do believe that the scientific evidence shows that mammograms save lives.  We do believe that colorectal cancer screening saves lives (and could save a lot more if we had more people screened).  We do believe the Pap smear has been incredibly successful in reducing deaths from cervical cancer in the United States and other developed countries.  Just take a look at what happens in the rest of the world when it comes to cervical cancer, and the fact that women all over this planet are dying from this disease because they don’t have access to any form of screening or treatment for what is now a largely preventable disease.


The reason we accept the risks of over diagnosis and treatment is that we believe the evidence shows that these screening procedures—when applied to large numbers of men and women—do save lives.  But, we are not blind to the questions that must be raised and must be answered before a population-based recommendation is made.


Then we find ourselves presented with anecdotes such as those shown on television where a woman says she has decided against mammography, or someone decides they don’t want to undergo colonoscopy.  Those are individual decisions that all of us make at one time or another in our lives.  Even I have declined to get certain recommended tests from time to time based on my knowledge and considerations of benefits and risks.


Those are personal decisions. But when the American Cancer Society makes recommendations for the prevention and early detection of cancer, we have to consider what is the best course of action that applies to hundreds of millions of people.


We don’t know who is going to get cancer and who is not.  We don’t know which cancers are potentially lethal and which ones are not.  We don’t know which cancers are going to be impacted in a good way by being found early and which ones are not. 


All of those questions are legitimate to ask.  But all of those questions also require further research—which is ongoing and funded by a number of organizations—to help us get the answers.


Until we have those answers, we also realize that our approach to screening and treatment sometimes is a lot more “rough-cut” than we would like.  But we are also of the opinion that we need to accept that significant limitation, understanding that lives hang in the balance.


We also recognize very clearly that when we don’t have the evidence that screening works, we say so.  Such is the case with prostate cancer screening, where we clearly advocate that men have a discussion with their doctors or other health care professionals to discuss the pros and cons of prostate cancer screening, as outlined in my blog earlier this week.


If I seem a bit angry and perturbed about this debate, it’s not because I am a true believer that every cancer could be caught early (they can’t; screening isn’t perfect) or that every cancer caught early represents a cure (that’s not the case).  But I have been around long enough—unlike some folks—to remember what life was like in the 1960’s and 1970’s before we had any of this evidence about screening.


I remember what it was like to treat women with “early” breast cancer in the days before effective mammograms were available, when a lump was palpated by the woman or her doctor and we told her it was “early” cancer.  Many of those women went on to die from their disease.  The cancer wasn’t early, and we didn’t have particularly effective treatments.


I remember women walking into the emergency department with towels wrapped around their breasts, bleeding from a mass or having discharge from the nipple.  There was no screening, and living five years for many of these women was considered a miracle.


I remember the data from a large national breast cancer treatment research group published in 1969.  Their report discussed the size of the average breast cancer, and the number of lymph nodes involved at the time of diagnosis for a large number of women.  The bottom line: the overwhelming majority of breast cancers approached an inch or larger in size, and the majority of women had lymph nodes involved with cancer.  The verdict was in before the treatment could be applied.


We used to take women to the operating room telling them they may wake up without their breasts, and routinely did extensive surgery under their arm to take out their lymph nodes.  We thought that doing this type of surgery would save lives.  And then we learned over the next number of years how wrong we were.


I remember caring for people who developed rectal bleeding and were found to have colon cancer.  We didn’t have screening tests back then, and it wasn’t until some time later that we learned—through a clinical trial—that checking the stool for blood could reduce deaths from the disease.  Now we have effective tests to reduce deaths from colon cancer, yet we still have too many people dying from the disease.


To suggest that we have hurt more than we have helped through screening for those cancers where the evidence shows otherwise is in my personal opinion ludicrous.  Problems with early detection that need to be recognized and discussed? Yes. Worthless or overall dangerous? No, not when the benefits and risks are carefully considered.


I have no desire to go back to the good old days before we screened for various cancers.


I too look at data and I see the decline in deaths from colorectal cancer, breast cancer and cervical cancer.  And, as I point out in my lectures every time I discuss this issue, I see the decline in stomach cancer which I point out cannot be attributed to screening (it may be attributed to other lifestyle changes, or perversely to the overuse of antibiotics).


But I also show a slide which shows the dramatic decline in cancer death rates beginning in the early 1990’s which has occurred in large part because of a reduction of smoking and more effective screening and treatment for some of the common forms of cancer.


I also use slides that show the disparities in deaths among whites and African Americans in this country for breast cancer and colorectal cancer.  Those disparities did not exist before screening for those diseases became widely adopted.  Now, we try to pacify ourselves that there must be a biologic difference in disease related to race.  I will leave it to the experts to argue that point, but from where I sit it sure looks suspiciously like an access to care issue, with difficulty for too many in the African American community to get appropriate screening and treatment.


I would suggest that cancer screening—as imperfect as it may be—is not the place to start cutting back on your health care. 


Yes, we need to make certain that we understand the benefits and risks of screening before making recommendations to everyone as to what they should do.  We need to make certain that men understand what we know and what we don’t know about prostate cancer screening.  We need to complete the clinical trials to find out whether or not lung cancer screening and prostate cancer screening really saves lives.  We need to fund research to help us develop better approaches to screening which will hopefully help us pinpoint which cancers we need to worry about, and which ones we can leave alone.


But until that time of perfection comes, please do not provide us with scare stories or horror stories that strike fear into our hearts.  Inform us, educate us, guide us.  But do not scare us.  That is a terrible disservice, in my opinion.


Please, please, please do not take us back to the days of yore when the word cancer was spoken in hushed tones and no one dared discuss it with their loved ones because the outcome was almost always horrific.


I have been there, done that, and don’t want to do it again.


The Overdiagnosis of Prostate Cancer: Is It News?

by Dr. Len March 10, 2009

An article and editorial in today’s edition of the Journal of the National Cancer Institute about prostate cancer screening highlight the differences between the messages of science and the expectations of the media and the public, and how the two intersect.


The end result is that the science message from the article may be converted into a bit more sensational story than suggested by the conclusions of the research.  After all, talking about science simply isn’t sexy.  Talking about how medical tests harm patients is a surefire way to capture the attention of the public.


The research, which is interesting and well done from a science point of view, deals with the difficulty we have getting our arms around the fundamental question of how many prostate cancers are diagnosed by screening for the disease  to find it early that would otherwise not cause a man harm or death.  This is what doctors call “over diagnosis.”


The paper starts out by noting that previous studies claim the over diagnosis rate for prostate cancer—which is the percentage of prostate cancers diagnosed that never would have been a problem for a man—has ranged from 25% to over 80% of cancers diagnosed by prostate cancer screening.  That is a lot of men who apparently have no benefit from having been diagnosed with this disease.


The researchers then took a more careful look at the question of what the real number should be, by using different complex mathematical models and standardizing various definitions as part of the study.  They found that from 42% to 66% of prostate cancers were “over diagnosed.” 


The other interesting observation was that these cancers were diagnosed from 6.9 to 7.9 years earlier than would have been the case without screening.  This is what we call “lead time bias.”


The conclusion?  According to authors, “The precise definition and the population used to estimate lead time and over diagnosis can be important.”


The authors go on to say, “ The lead time and the likelihood of over diagnosis are quantities that are critical in the assessment of the likely benefits and costs of any screening test; yet, in the case of PSA screening, results have been variable and confusing. This article is the first, to our knowledge, to closely examine the reasons for discrepancies across studies. Our results clearly show that the context or population used to derive the estimates, the definition of lead time used, and the estimation methodology all have important roles.”


Now, I am not saying that this research isn’t good work.  It is, and it is important work.  But it is important to scientists who study this problem, and probably not very interesting to most of the lay public.


The editorial which accompanied the article did in fact go on to relate the study itself to the questions surrounding the impact of prostate cancer screening. 


The editorialist concluded—as does the American Cancer Society—that we really aren’t certain how many men we are helping by screening for this cancer.  Until the evidence is in, both the editorial and the American Cancer Society along with a number of other highly regarded professional and science-based organizations recommend that men review the pros and cons of prostate cancer screening with their doctors.


This question is important, because since the advent of prostate specific antigen testing (PSA) in the late 1980’s, there has been a considerable spike in the number of men diagnosed with prostate cancer.  There was also an initial surge in deaths from prostate cancer in the United States after we began using the PSA test, followed by a substantial decline in prostate cancer deaths in this country that continues through the present day.


The problem is that we can’t specifically tie the two events together in a cause and effect relationship.   The same trends have been seen in other countries that do not regularly screen for prostate cancer.  There are also discrepancies here in the United States when you compare areas where men are regularly screened for prostate cancer and other areas where they are not.  Death rates have been dropping under both scenarios.


In the meantime, long term (and I mean long term) clinical trials to find out whether or not screening for prostate cancer saves lives have been ongoing in the United States and Europe, and we are still awaiting the results.


On top of this dilemma we have the fact that we are ramping up the war against prostate cancer.  We are employing new surgical techniques such as robotic surgery and engaging proton beams to treat the disease.  These approaches may be saving lives, but we don’t know for certain which man actually benefits from these treatments.  And they come at a not insignificant financial and personal cost.


Inevitably, as you treat a man for prostate cancer—especially an older gentleman who may have other significant medical condition—you run into situations that are not pleasant.  Pain, bleeding, incontinence, and impotence are not uncommon.  Surgical deaths do occur. 


When we screen for a particular cancer, we want to know that we are helping more than hurting.  We call this the “benefit vs. risk” ratio.  When the benefits outweigh the risks, it’s a good thing because we save lives.  Screening for breast, colorectal and cervical cancers on a routine basis are examples of effective use of screening.


On the other hand, if we hurt more than we help when we screen for a particular cancer, it is not a good thing.  Prior studies suggested that was the case for lung cancer.  Newer clinical trials are underway using CT scans to find out whether our current technology may improve that situation.


Prostate cancer screening may fall somewhere in between.  There are strong voices on both sides of the argument whether or not prostate cancer screening works.  That’s why the American Cancer Society recommends you have an informed conversation with your health care clinician before embarking on a course of routine annual screening with the PSA test and a rectal exam to look for prostate cancer.


Another factor we consider when making a screening recommendation is how many people will we treat where it wouldn’t have made a difference?


That may sound strange to some, because it is the commonly held belief that every cancer is a bad cancer that will cause harm.  But that’s not quite true.


We have known for decades that there are several different types of cancers that may exist in our bodies but never become apparent to us or our doctors. 


For example, we know that many people have thyroid cancer that in the past would never have been diagnosed and never caused harm.  Now, with our newer methods to look at the thyroid gland, we are finding many more cancers.  We may be diagnosing more thyroid cancer on a population basis because we can find them, but it isn’t clear that there are in fact more thyroid cancers being found that would have led to serious medical consequences if they had never been discovered in the first place.


We have also known for decades that prostate cancer was close to universal in men who approached the century mark in their lives.  But those cancers were found incidentally at autopsy, and never caused a problem.  Even men like me (I am not going to reveal my age here, but my hair is a bit gray) have a fairly high percentage of prostate cancer that would be found if one decided to go looking for it, even with a very normal PSA test.


So here we are on the horns of the dilemma which I mentioned earlier in this blog.


There are many, many men out there who firmly believe that prostate cancer screening saved their lives.  There are many expert physicians who agree with them. There are many expert physicians who do not agree.


There are many hospitals and community organizations that regularly run “prostate cancer screening fairs” as a means of finding men with this cancer (who then go on to spend thousands of dollars at the hospital and/or the medical practice or elsewhere when they receive treatment for their prostate cancer).


But here is what we know and have known for some time:


We test a lot of men for prostate cancer.  We find a lot of men with prostate cancer.  There are many men we treat who probably would have been fine without finding their prostate cancer.  There are many men we treat where our treatment didn’t make any difference, and they would have died from their prostate cancer no matter when we diagnosed it or how we treated it.  There are some men we treat where finding the cancer through screening probably did save their lives.  And for many of the men in each of these groups, we have changed the quality of their lives forever and not necessarily for the better.


The problem is we don’t know which men belong in which category.


So I come back to my initial thought: here is a well done research study published by reputable investigators in a reputable scientific journal that makes a legitimate scientific point.  And the editorial expounds appropriately on the implications of the research relative to the impact of prostate cancer screening.


That’s important, but it isn’t really news to many of us familiar with this issue.


I suspect you will be hearing about this story and its implications in an entirely different context, and probably in a way that will cause you concern and lead you to ask questions that really in fact are not related to the primary purpose of the research.  In fact, the reports may actually frighten many of you.


Hopefully the news stories will lead you or someone you love to have a better understanding of the controversy surrounding the “early” diagnosis of prostate cancer.  Hopefully that will lead you to have an honest discussion with your doctor.  Hopefully you will become more informed about this aspect of your health care.  Someone who is informed about their health will likely be someone in better health.


Maybe that isn’t such a bad thing after all. 

Public Health Meets Policy: Colon Cancer Screening

by Dr. Len March 09, 2009

It’s fitting that during Colorectal Cancer Awareness Month there is an intense discussion in the medical and regulatory communities and elsewhere about whether or not we should offer Medicare patients the option of a new screening test for colorectal cancer (CRC).


The test is called CT colonography (CTC), or virtual colonoscopy.  In short, it is a CT scan that can find polyps and cancers in the colon with x-rays.


As of now, the odds are against coverage for this test by Medicare.  But there is still time for the Centers for Medicare and Medicaid Services (or CMS, which runs the Medicare program) to review comments from interested parties and perhaps reconsider its recent preliminary “non-coverage” decision.


I previously wrote about CTC in 2007 when an article was published in the New England Journal which supported the use of this test as an alternative to traditional colonoscopy for CRC screening.  Another article published more recently in September 2008 reported on the results from a carefully done trial where CTC was compared with traditional colonoscopy as a screening test, and fared well.


In March of 2008, the American Cancer Society published new guidelines for the prevention and early detection of colorectal cancer.  The Society was joined by other professional organizations in writing these guidelines.


One of the key recommendations in that report was that we should favor tests that can prevent colorectal cancer, primarily through the detection of pre-cancerous polyps which, when removed, do not go on to become cancers.  It was in this vein that CT colonography was recommended as another option to find these pre-cancerous polyps as part of those guidelines. 


But despite this recommendation, concerns about CTC have persisted.


One key issue surrounding CTC is that if a polyp or lesion suspicious for cancer is found on the x-ray, then the patient still has to undergo a traditional colonoscopy to remove the polyp or biopsy the abnormal lesion.  


Some centers can do this immediately “on demand.”  But many cannot, so it means the patient would have to undergo another bowel cleansing and colonoscopy on a different day.  Going through a bowel prep for colonoscopy—whether CTC or traditional—is not anyone’s idea of a fun time.


The good news is that with improving technology, CTC has become much more effective at finding polyps that are more commonly associated with a higher risk of becoming cancer.  And that technology continues to improve.


Unlike traditional colonoscopy, a CTC does not require anesthesia and has a much lower risk of perforating the bowel, which can happen with the traditional study more often than most people realize.


On the other hand, CTC can be an uncomfortable test.  It requires that air be forced into the colon while the patient lies on their stomach.  Some people find that actually painful.  There is also concern about the radiation dose associated with CTC.


Looming over all this is the fact that CTC is essentially a CT scan, and CT scans of the abdomen will find other things that may or may not be significant.  That could lead to further diagnostic tests and surgery that might otherwise not have been needed for something that would never have caused a problem for the patient.


The American Cancer Society and its collaborators reviewed the evidence and thought that CTC should be an option for patients to consider “on the menu” for colorectal cancer screening, along with testing the stool for blood, routine colonoscopy, barium enema and sigmoidoscopy.


Others have reviewed the same evidence and came to different conclusions.  They did not think the evidence was sufficient to support CTC as an alternative for CRC screening.


More recently, Medicare was asked to review the evidence on CTC and make a nationwide determination as to whether or not it should be available for people on Medicare.


There is a very specific approach called a “national coverage decision” (or NCD) used by CMS to make these determinations.  (Much of Medicare coverage is in fact based on “local” determinations by Medicare carriers, but that is beyond the scope of this discussion.  In this case, the determination was going to be made by the central office in Baltimore).


As part of that determination, they reviewed a significant amount of evidence including a recent review and recommendation from the United States Preventive Services Task Force that there was insufficient evidence to support CTC as an effective screening procedure for CRC.


The result is a preliminary conclusion from CMS that the test will not be covered.


Why is this so important, and why are so many organizations—including the American Cancer Society—working to have this decision reconsidered, or at least subject to further careful ongoing evaluation to answer some of the questions raised by CMS and the USPTF?


Colorectal cancer is the second leading cause of cancer death in this country.  It affects both men and women, and overwhelmingly occurs in people age 65 and older.  It increases in frequency the older we get.


We know that colorectal cancer—which currently takes the lives of almost 50,000 people a year in the United States—could be prevented in many cases or at least found early if we followed the current recommendations to screen for the disease. 


Right now, some estimates are that about one-half of the people age 50 and older are getting screened.  My personal hunch is that number is actually inflated.  But even so, if only 1 in 2 people are taking advantage of screening for colorectal cancer, then we could do much better.


“Much better” in this case means that we could save thousands of lives every year when it comes to colorectal cancer if we only applied the knowledge we already have about screening for this disease.  Even if we were perfect, we wouldn’t find every case.  But, we would be a lot better off than we are now.


When you look at the age when colorectal cancer is diagnosed in the Medicare population, and realize that it takes 10 years or longer for many polyps to develop and become cancerous, then you wonder how many lives could be saved or at least relieved from the suffering that colorectal cancer brings, even if it occurs near the end of life.


It is my opinion and that of my colleagues here at the American Cancer Society that CTC could help reduce the disability and death from this disease.  I suspect it will encourage more people to be screened for this cancer.  Some of those people—especially those in rural America--may not have access to colonoscopy, given the shortage of trained colonoscopists in this country.  CTC would probably assure 60-70% of the people screened with this new “virtual” test that they don’t have a problem and don’t need to go on to routine colonoscopy.


Treating colon cancer—especially when it spreads—is becoming more and more expensive, with the newer chemotherapy and targeted therapies that have become available.  Reduce the incidence of CRC by finding a polyp in the colon before it becomes cancer and you not only reduce suffering but you reduce costs as well (by the way, estimates used to look at the cost effectiveness of CTC as part of this process used data from 2003, which was well before the newer expensive drugs became available).


So, we find ourselves on the horns of a dilemma. 


The American Cancer Society and others say CTC is an effective test and should be available from appropriately trained physicians and centers.  Others look at the same data and conclude the test is not ready for prime time, calling for additional studies.  Still others say we can do those studies while we are providing access to CTC with appropriate quality controls, yet there is no money to do the studies.


In the meantime, lives literally hang in the balance.  And the people whose lives are hanging have no idea that they will be victims of colorectal cancer 5, 10 or 15 years down the line.


We need to take a careful look at how we spend money for health care in this country.  That is no secret and no surprise.  But here we have an opportunity to do this the right way, while at the same time working together to answer the questions and be certain we do get it right.


Maybe CT colonography as a screening test is just the right place to start asking those questions and getting the answers, while saving lives as part of the process.


I don’t think from a public health or public policy point of view it gets any better than that.  But first, we need Medicare’s help to get it done.

Filed Under:

Colon Cancer | Medicare | Screening

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.