Sometime patience pays off.  And sometimes patience means you think you have come to the end of the road, only to find that someone has built an extension for the highway.

That’s the outcome from the next study, which reported that the use of a tumor vaccine in patients with a non-Hodgkin lymphoma called follicular lymphoma were found to have longer remissions after chemotherapy if they received the vaccine when compared to patients who received the same treatment but did not get the vaccine.

This research was no flash in the pan.  The basic research which led to this study was first reported in a well-known medical journal back in 1999.  Ten years later, we have a report that the use of the vaccine in a select group of patients who were able to have their disease successfully treated and remain in remission for at least six months increased the time to progression of 44.2 months, compared to 30.6 months for the patients who also achieved a complete remission for at least six months but did not receive the vaccine.  That is over a 14 month improvement.

But this was a very select group of patients.  First, they had to have a lymph node large enough to make the vaccine.  Then, they had to achieve a complete remission of their disease on chemotherapy.  Then, they had to remain in remission for at least six months before the vaccine could be started.

Each of those requirements puts in place another filter that might influence the results of the trial.  And, as the author points out, when you look at the entire patient population with this disease, and given the effectiveness of newer for this disease treatments (which became evident during the time this trial was in progress), there in fact is not that much difference in the “real world” results in survival for both groups.

The researchers concluded that the vaccine did work.  The side effects were limited, and the vaccine may be useful in treating these patients in practice.  But we are now in a different era in the treatment of this disease, so it is basically back to the drawing board to see if the vaccine still helps in the face of newer, more successful drugs for this lymphoma.  Discussions with the Food and Drug Administration for drug approval are ongoing.

In discussing the presentation, Dr. Ron Levy from Stanford University School of Medicine made the point that lymphoma cells have unique markers not common to other cells in the body.  That is what makes this cancer a disease where a vaccine may be useful.

We now have antibodies against this target, and we have therapies based on these antibodies that are successful in treating follicular lymphoma. We can use that same target to make a vaccine.

Dr. Levy went on to ask several questions in his discussion, including: Is this result a positive result?  Could there be a role for active vaccination in patients with this disease?

He noted that this was a small study with 117 vaccinated patients.  The chemotherapy was not a “popular” chemotherapy.  Not every patient achieved a complete response and others could not maintain a complete response.  There were other unanswered questions about that study that, according to Dr. Levy, could have led to unintended biases in the results.  Finally, he concurred with the same comment that I noted above, namely that these patients were the “best of the best” in terms of the opportunity for long-term remissions for their cancer after their treatment.

Will vaccination be part of standard treatment?

As noted by Dr. Levy, the world of treating follicular lymphoma has not stood still.  The use of rituxumab (Rituxan) has shown a “powerful advantage” in improving the treatment of follicular lymphoma.  In order to find out whether this current vaccine has any value in today’s treatment program to improve the outlook for patients with follicular lymphoma, a new trial would have to be done.

Dr. Levy’s conclusions: a “qualified yes” that the trial is a positive result.  But there is much more work to do.

Which brings me back to my first comment: After years and years of work, we have a success but it is a qualified one.  It demonstrates the concept, but we don’t know if it will make a real difference in the outlook of patients treated with more modern approaches to follicular lymphoma.  We still need to travel further along that extended highway.

That, my friends, is what we call a conundrum.

It is day two of the annual meeting of the American Society of Clinical Oncology in Orlando.  Over the next three hours, we will hear the four papers which have been selected for the plenary session of the meeting for presentation to thousands of researchers, doctors, and other cancer professionals.  These are, in one sense, the best of the best—the ones which will likely get the most media coverage and be of interest to largest number of meeting attendees.

The first paper that is being presented in an interesting one, if for no reason other than for its seeming simplicity (I promise you, nothing in cancer medicine is simple).  The bottom line: trying to seek out evidence of ovarian cancer recurrence after successful treatment for  metastatic disease and starting immediate treatment made no difference in survival when compared to waiting until a woman had symptoms related to that recurrence and starting treatment at that time.

Talking to patients and getting an idea of how they are doing is becoming a lost art in this age of medical technology.  The history and physical is becoming a lost art.  Yet surgeons knew a long, long time ago—well before CT scans and other fancy things were routinely available—that looking at a patient after an operation could tell them a lot about how that patient was coming along post-operatively.

And as a practicing internist, I can’t tell you how many patients would ask me during an office visit how they were doing.  My stock reply was basically that they already had told me through their initial discussion.  Listening to them told me how they were doing with their illness, well before I had the results of the lab tests. 

The bottom line: if we listen to ourselves and listen to our bodies when we are ill, we can frequently get a clue as to how our health is progressing—at least if we are reasonably honest with ourselves.

So what did today’s research report show?

In this study, the doctors followed women who had an excellent response to chemotherapy for their advanced ovarian cancer over time with a blood test called CA-125.  CA-125 is a blood test that is associated with ovarian cancer, but occasionally can be elevated for other reasons.  Sometimes CA-125 is used to screen women at high risk of developing ovarian cancer, and it has not been shown to an effective screening method for ovarian cancer. Its main use has been to follow women already diagnosed with ovarian cancer to get an idea of how their cancer is responding to treatment or if it is recurring.

The women in this study had already responded to chemotherapy and were off therapy.  They had serial blood tests, but the results of the tests were not released to the women or their physicians.  When the CA-125 started increasing, the women participating in the study were randomly assigned to either telling them and their doctors that the cancer was relapsing while the other women and their doctors were not told about the rising CA-125.

The women  in the first group were started on new chemotherapy.  The other women were not started on additional chemotherapy until they developed symptoms.  It turned out that it made no difference in survival whether or not treatment was started as soon as there was early evidence of cancer recurrence.

This study was simple in its construction, and straightforward in what it shows us: earlier chemotherapy in this particular situation did not make a difference.

This study is certain to get a lot of comment.  But I must say that I am not particularly surprised. 

Years ago, I used to have conversations with many patients who had advanced cancer who were otherwise feeling reasonably well.  Our treatments at that time were fairly simple, and not very effective.

There were a significant number of patients who had certain types of cancer—frequently breast cancer or colon cancer—who had progression of disease, but in whom the progression was moving slowly.  Symptomatically, they felt well.  They were going about their business, enjoying life, working daily—despite knowing that their cancers had returned.

When the rate of progression picked up, and when we thought (through mutual discussion) that chemotherapy might have a chance in improving their outlook either through symptom control or increasing their survival, we would start chemotherapy.

I was never convinced at that time that we hurt the quality of life or the length of life for those patients.  Some of them went on for a considerable time before they needed treatment.

That’s not much different from the results of this study.  We are “primed” to do everything possible to find the earliest possible recurrence or progression of various cancers and treat or change treatment at that exact moment.  In no small part, PET scans have had the greatest impact in this regard.  A new lesion found on a routine PET scan performed for surveillance and a little new lesion is found, and whamo!!! it’s off to the next treatment—even when the patient is feeling perfectly fine.

It’s not clear to me and many of my colleagues that we are necessarily helping our patients when we do that.  This study—although limited to ovarian cancer—pretty much reinforces that conclusion.

The study was not without criticism, including the way the patients were treated according to current surgical and chemotherapeutic standards.

A commenter at the meeting pointed out that in ovarian cancer, despite the best treatment, contains areas of cancer cells that resist therapy and grow over time.  Those cells continue to grow despite prior treatment.  So when the cancer is treated a second time with chemotherapy—as was the case here—it would be expected to have less effect than the first time around.  The conclusion from this discussant was in fact that we don’t have evidence that monitoring CA-125 every three months produces any real benefit, and we should no longer monitor women with this test after their primary treatment for metastatic ovarian cancer. 

The outcome, in her opinion, would be a reduction in the costs of care and an improvement in the quality of life.  But, she asked, “What will patients accept?”  She noted that normal CA-125 levels lift patients’ spirits, while small increases induce depression.  And, in some women second and third surgeries to remove recurrent cancer can produce meaningful increases in survival.

The unfortunate logic is that the outcome of this research is not unanticipated or surprising.  And, with more chemotherapy—as pointed out in the study—there are more side effects, a poorer quality of life, and risk the possibility of increasing the risk of premature death.

Our technology is terrific, but the question persists as to whether or not it really improves the outcomes of our care.  I would suspect that we will see more of these types of studies, especially in this era of health reform and very, very expensive cancer treatments.

So maybe those old docs were right all along: listen to your patient, and you will hear how they are doing.   Maybe in some respects, it wouldn’t be a bad idea in certain situations to go back to the future, after all.  But we cannnot forget that there is still much we have to learn about cancer in general, and ovarian cancer in particular.

This morning I am in Orlando at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, listening to an address by the outgoing President of ASCO, Dr. Richard Schilsky from the University of Chicago.

Although these types of talks are generally perfunctory and organizationally oriented, this one actually made some interesting points that show how far cancer care has come, how far it has to go, and how many obstacles stand in the way of progress.

For example, do you know that there are currently over 700 drugs currently in the testing pipeline for cancer care? 

Dr. Schilsky pointed out that we simply do not have the resources to test all these drugs.  On top of this despairing thought, the fact remains that only 5-8% of those drugs will actually go through the clinical trial gauntlet and get to the clinic and help cancer patients in their quest to survive their disease.

There are a lot of reasons for this dilemma, but one of the most serious is the amount of work it takes before a clinical trial cooperative group such as the CALGB, a large national research organization of major cancer treatment centers dedicated to testing treatments for cancer, can develop and launch a clinical trial for cancer treatment, let along complete it.

Dr. Schilsky pointed out that the first cooperative clinical trial run by the Cancer and Acute Leukemia Group B (CALGB) and reported in the late 1950’s took about 18 months from conception, to completion and report in the medical literature.

Today, with all the requirements and paperwork associated starting a new clinical trial, it takes 2 years of planning before the trial can ever admit the first patient.

And then there is the question of whether or not patients’ costs for clinical trials will be covered if they elect to participate in a clinical trial.  Putting aside the question of whether or not they even are aware or have potential access to such trials,  patients quickly discover that some insurance plans cover the routine care costs associated with such clinical trials, but many do not.  ERISA plans and (surprisingly) the Federal Employee Health Benefit Plan—which is being touted as a model for our healthcare reform going forward—do not cover costs for participation in clinical trials.

Imagine 700 drugs in the pipeline, and 2 years of planning to get each one tested, and a high failure rate of 92-95% and you begin to get an idea of why moving cancer treatment forward is so darned difficult and slow.

There are some hopeful signs on the horizon, as pointed out by Dr. Schilsky. 

For example, as noted in the theme of this conference which is “Personalizing Cancer Care,” we are learning more about what characteristics of a person’s cancer will predict their future course, whether or not they require preventive (adjuvant) chemotherapy, and whether or not certain drugs and targeted therapies will work for a particular patient’s cancer.

We are also now on the threshold of finding genetic markers which will predict which patients will benefit from which supportive treatments, and who will have excessive side effects such with drugs used to manage cancer.

At the same time, we are also going to have to learn how to apply all the technology we have at our disposal.  We cannot continue to spend with abandon without expecting a return for that investment in patient care.  Will it help?  Will it work?  Will it make a real difference in the care we provide our patients?  We need to do a better job of asking those questions, and restraining ourselves (both patients and physicians) when the answer is “no”.  We need to be better stewards of our limited financial resources when what we do won’t make a real difference in the outcomes of our care.

Weaving this complex fabric with basic research, development of new drugs and treatments, clinical trials, health information and technology and many other aspects of cancer care, overlaid on the issues of health care costs, access to care, disparities and regulatory/legislative issues is a monumental task.  But we must address all of these important areas if we are to move forward in our progress in reducing the burden and suffering from cancer.

These next several days here at ASCO will see a massive exchange of information about cancer, in all its dimensions.  Thousands of abstracts will be presented, hundreds of smaller meetings will occur, and uncountable small discussions will transpire. Much of this exchange will be lost in the volume of information to be absorbed, and a few elements will rise to the top and truly impact cancer care now and in the future.  Progress is clearly slow and incremental.  “Overnight breakthroughs” (which actually take years to accomplish) are clearly the exception and not the rule.

Ultimately, this complex interaction occurring on so many levels results in progress in cancer care.  But—as outlined by Dr. Schilsky--we must do a better job of reducing the barriers and increasing the opportunities.  Otherwise we will not realize the potential of the incredible progress that is now within our grasp.

When it comes to communicating, the world has certainly changed a great deal.  Instant access, instant information, immediate worldwide coverage of events—these are just a few of the things that we now take for granted.

Today, cancer patients, their families, friends and colleagues can take one step forward in that information world as the American Cancer Society in partnership with Microsoft’s HealthVault unveils a new internet tool on our website called “Circle Of Sharing™” that will help cancer patients take charge of their care, and communicate information more effectively to those friends, families and others who support them through the difficulties of their illness.

The Circle of Sharing™ will help cancer patients, their families, care partners, friends, colleagues and medical team put the information they need in one place.  It is designed to organize the information, control the communication flow, and avoid the need to repeatedly answer the same questions or give the same information.  It is designed to help catalogue important medical information, get support when you need it and want it, get reliable answers to important questions all while keeping you as the patient in control of everything.

(You can access Circle of Sharing™ at www.cancer.org/circleofsharing.)

I remember a time when the word cancer wasn’t even uttered in polite company.  Mentioning the word in my family when I was young would draw a rebuke or even worse.  You just didn’t talk about it.  The “sharing index” was somewhere below zero when it came to cancer.

When I was older, and was training to be a doctor and then a specialist in internal medicine, I met patients all the time who knew they had cancer, but couldn’t let their families know they knew.  That’s because the families didn’t want them to know the diagnosis, as though having a conversation about the topic might otherwise depress or irreparably injure the patient’s psyche.  The charades would go on and on and on.

And then I became an oncologist.  In training, we saw patients from all over the globe who came to our center for cancer treatment.  When I completed my training and went into practice, I actually had referring physicians threaten to withhold patients from me if I told them they had cancer—even when I was putting them on toxic treatments where I needed the patient’s and family’s full cooperation.

Changing that paradigm was a huge task, and it frequently wasn’t a pleasant one.  My rule was that if I couldn’t talk to a patient about their diagnosis and their treatment, then I couldn’t have them in my office as a patient.  It was a tough year or so, but the ground was broken and we all moved forward to what was then a new era of openness about cancer.

The world fortunately has moved on.  Patients and families know the diagnosis, hopefully know their treatment options, and also hopefully have more honest discussions about their future and their wishes.  It isn’t easy by any stretch of the imagination, but it is much more supportive and opens the door to caring and sharing, which is such an important part of cancer care today.

At the same time, we have the means to communicate instantly with so many people and access information from resources throughout the world.  Usually that’s a good thing, but sometimes it can be overwhelming. 

Circle Of Sharing™ is designed to help make those tasks less complicated and more reliable. Getting our arms around all the information, all the communicating, all the sharing, all the “best wishes” can sometimes be a daunting task—especially when we are seriously ill and undergoing difficult treatment programs.

The Society and HealthVault have gone to great lengths to protect your privacy, and allow you to control who sees what information on your Circle of Sharing™ website.  It is no secret that one of the major concerns of those who keep medical information on line is whether or not it is safe, secure, and under the individual’s control.  On Circle of Sharing, you create your own customized internet “world”, recording your medical information as you obtain it (such as diagnosis, side effects, important treatment dates), create your email lists and records, look for articles on the Society’s highly respected and authoritative website (www. Cancer.org), and decide which parts of the record you want to share with whom.

Ultimately, we will see the day when our medical records system will allow us to automatically build our individual websites, as information is uploaded directly into the system.  In this somewhat utopian world, your medical information will in turn trigger various prompts and reminders about your health to get you well and keep you well, it will provide you with options to get reliable information about your health, and will serve as a resource for those who provide your medical care so you don’t have to keep repeating the same information again and again.

Some places in this country are moving closer to that ideal.  For many, it is still a dream.  For cancer patients, the Circle Of Sharing™ takes us much further down the path of helping them regain control of their lives at a very difficult time. 

My colleagues and I at the American Cancer Society hope that the Circle Of Sharing™ will help make life just a bit better and a bit easier for patients with cancer at a time when everything may seem so complicated and difficult.

We look forward to hearing from you about your experiences with the Circle Of Sharing™.

Every year the American Cancer Society publishes a detailed analysis on the incidence and deaths from cancer in the United States. This year’s report—released today—is no exception.  It shows in clear and graphic detail the impact of cancer in terms of the number of times each cancer is diagnosed, and how many deaths we can expect. 

Once again, I keep coming back to that figure as a clear and convincing demonstration that we have made real progress against these terrible diseases we collectively refer to as “cancer.”

What has happened?

In short, many of the gains have been in a limited number of cancers.  For men, we have had significant decreases in the rate of cancer deaths because of declines in tobacco related cancers (especially lung cancer), colorectal and prostate cancer.  For women, the decreases in deaths are due primarily to declines in death rates from breast and colorectal cancer.  (Unfortunately for women, since they took up the smoking habit about 20 years later than men, the decline in female death rates has leveled off but not declined since there is a considerable lag time from when a population stops smoking until they see a decline in deaths from cancer.)

When you look at the total numbers of deaths from cancer, you see another remarkable statistic.  Despite the fact that we have become much larger and older as a country when comparing 1990 to 2005, the number of cancer deaths has not increased as dramatically as the age and size of the population.  In 1990, there were 478,888 deaths from cancer.  In 2006, the number was 505,322.  When you consider that the most significant risk factor in general for cancer is age, and you consider that there are a lot more of us now than back in 1990, this relative stability in cancer deaths is truly remarkable.

But not all the news is good news.  Cancer still remains the leading cause of death in this country for men and women ages 60 to 79 and for women ages 40 to 59. (It is the second leading cause of death—after heart disease—for men and women age 80 and older.)

There are also significant differences in cancer deaths across this country, which is most dramatically underscored by the lung cancer death rate in Utah (39.6/100,000 in men and 22.4/100,000 in women) compared to Kentucky (136.2 in men and 76.2 in women, respectively).  The reason is no mystery: Utah ranks the lowest in smoking prevalence and Kentucky is the highest.

And although we have seen a significant decline in some cancers such as those related to tobacco, stomach cancer, cervical cancer and lymphomas among others, we are seeing increases in death rates from other cancers such as esophagus, liver and melanoma in men and lung, pancreas and liver cancer in women.

Education and ethnicity also play a role in your risk of dying from cancer.  If you went to college, your chances of dying from cancer have decreased significantly from 1993 to 2001.  But if you have a high school education or less, death rates from cancer remained stable or increased.  And these patterns persisted no matter your race or your sex.  Consider this finding an “educational disparity”, one that cuts across all lines of race and gender.

The impact of this “educational disparity” is striking.  According to the report:

“If everyone ages 25 to 64 years experienced the same cancer death rates as the most educated, 17,650 cancer deaths in women and 30,940 cancer deaths in men could have been averted or postponed in 2001, accounting for over 30% of the total number of cancer deaths in this age group.” (emphasis mine)

How does this happen?  Probably it is related to a higher prevalence of risk factors among the less educated, according to our American Cancer Society researchers.   Smoking, obesity and limited access to medical care are most likely responsible for this striking and significant difference.

We also can’t forget that substantial differences in 5 year cancer survival persist in this country between whites and African Americans.  Although both groups have seen improvements in 5 year survivals for a number of cancers between 1975 and 2004, the sad reality is that for many cancers the 5 year survivals for African Americans woefully trails the 5 year cancer survival for white Americans.

Here is another piece of information you may find interesting: if you are a man, your chance of developing an invasive cancer if you live in the United States is now about 1 in 2 (44%).  For a woman, it is about 1 in 3 (37%).  But women have a slightly higher chance of developing cancer earlier (before 60 years) in large part because of their risk of breast cancer.

So what does it all mean?

If you are a statistics wonk, there is a lot of material for you to review by going to the article and reading it through. 

However, I suspect most of you are not.  So let me narrow all of this information down into a couple of bite size pieces:

1)      We have made a lot of progress in reducing deaths from cancer in this country over the last 15 to 20 years.  Much of that improvement is because we have cut down the use of tobacco, improved early detection (especially for breast cancer) and ramped up prevention (primarily colorectal and cervical cancer).  We have improved our treatments as well, especially adjuvant therapies for breast and colorectal cancer.

2)      Because of this progress, hundreds of thousands of Americans are alive today that would not be with us, if we hadn’t made the improvements in cancer care and cancer treatment since 1990.  Who knows how many more will never even hear the words “you have cancer” because they had a Pap smear, or got screened for colorectal cancer before a polyp turned cancerous, or because they didn’t smoke, or because they chose to lead a healthier lifestyle?  I suspect that number—although difficult to measure—is much greater.

3)      There is so much more we could do to reduce the burden and suffering from cancer if we only did what we already know: don’t smoke, eat a healthy diet, maintain a healthy weight and get screened.  And, of course, make certain that you can get to see a health care professional for your medical care, and even more important have access to adequate and appropriate preventive health services.

4)      Despite our progress, there still remain too many cancers that we can’t find early and can’t treat effectively, and too many people that we are simply not able to help despite our best efforts.

5)      And let’s not forget that we need to address the disparities in this country that are based on race and education, and which clearly impact the quality and quantity of our years.

We have made considerable progress in our efforts to reduce the burden and suffering from cancer.  We still have a long way to go.  That’s what these numbers tell us.

In releasing this report, Dr. John Seffrin, the Chief Executive Officer of the American Cancer Society, noted:

“Because the rate (of cancer deaths) continues to drop, it means that in recent years, about 100,000 people each year who would have died if cancer death rates had not declined are living to celebrate another birthday.  That is undeniable evidence of the lifesaving progress that we as a country must dedicate ourselves to continuing.”

That, my friends, is a thought worth holding on to.

It is hard to reconcile the raindrops falling outside my office window this morning with the fact that this weekend marks the beginning of the summer vacation season.  But that is what it is, and I know that somewhere someone(s) will be trekking off to a beach, a lake, a mountain, or an outdoor activity for a couple of days of fun and relaxation. 

So today is still a good day (the rain notwithstanding) to remind all of you that sun safety should be at the top of your mind as you head off to your well deserved and well earned weekend of fun.

Today is also a good day to introduce you to something new, which hopefully will remind you throughout the summer that sun safety is an important part of your outdoor lifestyle.  That “something new” is the first annual “Don't Fry Day” sponsored by the National Council on Skin Cancer Prevention, and its 45 member organizations who are dedicated to the cause of doing just what the organization’s name implies: preventing skin cancer.

“Don't Fry Day” may be formally acknowledged on the Friday before Memorial Day weekend, but every day you spend in the sun should be a “Don't Fry Day,” especially for the children and young adults in your family.

Skin cancer is far and away the most common form of cancer in the United States.  And, although fortunately for most of us it is treated simply and effectively, for others it can be very disfiguring and fatal.

Practicing sun safety is the one proven way to decrease your risk of skin cancer.  And, although prevention through sun safety is important throughout your life, it is especially important for young children and young adults.  Sunburns as a child or young adult are one of the major risk factors for skin cancer later in life.

What are the sun safety recommendations? 

You can keep this simple slogan in mind, and you won’t forget: Slip! Slop! Slap!...and Wrap.  Translated, it means: slip on a shirt (preferably one that has dark colors), slap on a hat (one with a wide brim is best), slop on the sunscreen (broad spectrum with an SPF of 15 or higher, applied liberally and OFTEN when swimming, sweating, or spending more than 2 hours out of doors), and wrap on a pair of UV protective sunglasses.

Take these simple steps now—especially when you are young—and you can likely avoid skin cancer later.  The more you sunburn, the higher your risk of developing not only the relatively “benign” skin cancers (called squamous cell and basal cell skin cancer) but also the much more dangerous and deadly form of skin cancer called melanoma.

Please note carefully what “Don’t Fry Day” does NOT mean.  It does NOT mean don’t go outside.  It does NOT mean don’t enjoy the outdoors.  It does NOT mean become a hermit in your house, or dress top to bottom in dark heavy clothes when you are hiking, fishing, or spending a day at the beach.  Good health includes spending time outdoors, where you are more likely to exercise and enjoy yourself.  Taking that away from people or suggesting that they should avoid the outdoors simply doesn’t make sense and isn’t realistic.  But it DOES mean that by taking some simple precautions, you can enjoy the outdoors and not pay a big immediate penalty with a horrible burn or later in life have a doctor lop off tens of cancers from your body, including from your ears and your nose.

If you want more information about “Don’t Fry Day” or sun safety in general, you can go to our website at www.cancer.org or to the website of the National Council on Skin Cancer Prevention at www.skincancerprevention.org.  The American Cancer Society has also posted a sun safety podcast on our website.  In addition. there are a number of organizations that are supporting Don’t Fry Day, including the American Cancer Society, the Environmental Protection Agency, the Centers for Disease Control and Prevention,  the American Academy of Dermatology and the Skin Cancer Foundation, among many others.

For the National Council on Skin Cancer Prevention we look forward to growing “Don't Fry Day” and making it part of our vacation season “celebration” every year for many years to come.

For you, we hope that you will take the message to heart that every day in the sun should be a “Don't Fry Day.”

Now, go have some (sun safe) fun!!!

Events of the past three weeks have left me thinking once again about what we do as oncologists and the impact of our decisions on our patients and their families for better or worse.

The primary driver of these thoughts was something that happened in my own family.  But the recent news about the boy in Minnesota with Hodgkin disease and his mother’s decision to forgo additional chemotherapy serves as a stark contrast to the circumstances that my own family has had to deal with around the very same question.

The person in question was my wife’s uncle.  He lived in a rural part of Georgia, and was a farmer, an educator and a counselor.  His greatest professional pride, however, was his work as a minister and evangelist.  He was in the ministry for 60 years, travelling across this part of the country, preaching his gospel.  He was indeed a man of faith, committed to his family, his community, his church and his religion.

Uncle Chester appeared to be a taciturn man, but his friends and colleagues were aware of an impish sense of humor that he apparently used often.  I will remember him most for the beautiful service and eulogy he delivered just a couple of weeks ago when another member of our family (my wife’s grandfather) passed away in his early 90’s.

Shortly after that service, we got a phone call.   Chester had cancer.  What should he do?

These discussions are never easy under the best of circumstances (and there really are never any “best circumstances” when it comes to cancer).  They are even more difficult when the person is someone you know personally, and is a member of the family.

The cancer probably started in the stomach.  It had spread to the liver.  Chester was rapidly losing weight. Earlier that week he had a CT scan which showed a mass in the stomach and tumors in the liver.  An endoscopy was performed, and the diagnosis was a poorly differentiated aggressive stomach cancer.

When I asked the day of that conversation whether he would be able to preach the eulogy now, the answer was a definite “no.”  He was pretty much bed-ridden, able to get out of bed from time to time with considerable assistance from his devoted (and wonderful) wife, but no, he could not preach the eulogy he had given just a couple of weeks before.  He had just been diagnosed, but the cancer was exceptionally aggressive and he was failing rapidly.

What do you say in a situation like that?  I talk and write a lot about cancer prevention, about finding cancer early, about new drugs and treatments and new ways of approaching cancer treatment.   I talk and write about the progress we had made over the past 35 years, how far we have come, yet understanding we have far to go. 

Yet here I was, with a respected and loved member of my own family, unable to offer anything meaningful.  There was no treatment, there was no clinical trial, and there was no cancer center that had a miracle to offer. Surgery was out of the question, radiation therapy had nothing to offer, and chemotherapy had limited benefit and certainly couldn’t offer cure or a significant chance of remission.

Chester was, as noted, a man of faith.  He believed in his Lord, he had worked a lifetime preparing for this moment.  He clearly was not afraid.  He knew his time had come.

In balance, I knew that chemotherapy would rob Chester of his dignity during his last days and may even hasten his end.  He knew that too, and being able to have that conversation with his family, his friends and his colleagues was truly the mark of a man in comfort, and not in distress.  He saw a local oncologist, who essentially confirmed what I had said.  He and his family chose to enter the local hospice program, and two weeks later—this past Sunday—he passed on.

The funeral was yesterday, led by three ministers from the Church of God of Prophecy.  They all spoke eloquently of their relationship with Chester, and what he meant to them, his parishioners and to his faith.  The stories were sometimes actually funny, especially the one about him preaching from the rooftop of a house.  He obviously touched many lives.

But one story stuck in my mind.  It was from one of the ministers who is a leader in the church.  He told of how he came to visit Chester, sat in the room with him, and talked.  He told the story of how Chester was at peace with himself and his God, how he accepted his death after a life lived well.  The minister marveled at Chester’s ability to sit in a chair and have that conversation, even when so near death.

The funeral was a celebration of life.  Sadness was present, to be certain.  But Chester wanted his family to wear brightly colored clothes, and that they did, since he knew this time would be a celebration of what he had accomplished with his life.  He was a proud man.

And for him, the decision he made was the right one.  Death came quickly, probably more quickly than even I anticipated.  My family went to see him the week before, and although weak he was still able to talk.  We could have recommended or encouraged chemotherapy, but it wouldn’t have been right.  It wouldn’t have given him much time, and it certainly would have made his final days a lot more difficult than they were. 

Chester Williams was a man of dignity who died with dignity.

Contrast Uncle Chester with the recent reports in the news about the young 13 year old boy with Hodgkin disease whose mother has decided to have him treated—according to those reports--with “natural healing methods” as opposed to chemotherapy.

Although it is always risky to comment about a medical case where you are not personally familiar with all the facts, what we do know that if this is indeed a stage II Hodgkin disease in a young person, then the chance of having a long term remission and even a clinical cure are substantial.  This is one of the very first diseases where we had successful treatment with radiation and chemotherapy.  Over the past several decades we have learned much about treating the disease, especially in young people.  Success is never assured, but unlike Uncle Chester, this boy has a real chance of living a normal life once he concludes his treatment.

This is a situation I would have handled much differently from Uncle Chester’s.  This is a boy at the beginning of his life, who may well have much to offer and much to accomplish.  This is a boy who has an excellent (although not guaranteed) chance of success with his treatment.  This is a boy who should be treated, in my personal opinion.

As I mentioned above, I have counseled many people over the course of my career.  I understood a long time ago that living to see the sun rise and have a heart beat is not necessarily living, if one is in pain, can’t eat, is bed-ridden, and suffering.  I know there are adults who make decisions that sometimes seem contrary to what we think are in their best interests.  I know that many adult children of older parents can’t understand why their parents won’t take advantage of every opportunity no matter the cost or location to get the best treatment for their cancer.

But I also know this is a boy with hope, and in my opinion his parents don’t appear to be acting in his best interests.  This is a situation that is the polar opposite of Uncle Chester’s.

Where Chester had little hope of recovering, this boy has much hope of a successful outcome.  Where the side effects of chemotherapy would have been debilitating for Chester, the benefits were limited.  For this boy, the side effects are serious and could likely be controlled, but the upside would be worth it.

When I talk about the progress we have made in the fight against cancer, I talk about the hundreds of thousands of people who have not died from their disease because of prevention, early detection and effective treatment.  I talk about the immeasurable impact they have on all of us, the “leveraging” of their existence and the value they bring to themselves, their families and all of us through their lives, their accomplishments and their good works.

When I think of this young man, I wonder what future value he may bring to himself, his family and society if he wins his battle with his cancer.  And I think what it must be like to stand in the way of that opportunity and encourage him not to pursue his life or his dreams.

So here we are: the older pastor who appropriately declined treatment and died with dignity, although much too quickly, and the young man with a life ahead of him that has now been made much more complicated and less certain by the course his mother has chosen. And I ask if anyone has the right to take away that opportunity, to take away that potential, to take away that dream.

There is an expression that I think about often: “He who saves one life is as if he saved an entire world. He who destroys one life is as if he destroyed an entire world.”

Uncle Chester saved many worlds.  This boy’s mother, unfortunately, seems intent on destroying them.

I suspect most of us appreciate the former.  I hope that most of us disdain the latter.

We now have the “final answer” from Centers for Medicare and Medicaid Services as to whether or not they will provide coverage for colorectal cancer screening with CT colonography under the Medicare program.  And the answer is: no.

To say the least, I am personally very disappointed.  Not that my opinion should be the driving force on a decision that may affect the lives of thousands of people.  But this is something that became a bit of a “cause” for me, in no small part because I felt it represented an opportunity to advance our medical science and knowledge at a time when lives could be saved.  It was an opportunity in my view to start setting the stage on how we can do things the right way in health care going forward, which will be a critical part of any reform effort.

In my opinion, we have failed to meet the challenge.

For me, the issue was reasonably straight forward.  We lose close to 50,000 people every year in this country from colorectal cancer.  We could save thousands of lives if we were able to get people screened for this disease.  The American Cancer Society believes that we should favor tests that prevent cancer, and has endorsed CT colonography as a reasonable test for this purpose.

For the most part, colorectal cancer is a disease of the Medicare population.  We can’t cheat death forever, but we could prevent needless suffering and deaths from colorectal cancer if we were able to screen more Medicare beneficiaries.

We aren’t making the grade with the screening tests we already have, for a variety of reasons.  If we were going to embrace a “prevention strategy” for colorectal cancer through the use of routine colonoscopy, research has shown that it would us years to have everyone screened.  There are simply not enough gastroenterologists around to get the job done nationwide.

CT colonography isn’t perfect, but it certainly appears to be a very reasonable test.  It is my opinion and the opinion of others that it would expand the opportunity for colorectal cancer prevention and early detection strategy to more people throughout the country.

Yes, there are questions as pointed out by CMS in their decision about detection of small polyps.  And there are questions about what happens if the scan shows an abnormality elsewhere, such as an unexpected lesion in the kidney or an aneurysm in the aorta.  And there are questions about radiation dosage.

Perhaps the most significant question as to what to do if a polyp is found and the patient has to undergo a se cond bowel prep for a colonoscopy on another date.  Not a pleasant thought, for sure.

How to solve the dilemma on what to do when opinions among respected experts differ?

We made a proposal to CMS that they consider a “coverage with evidence” decision (CED).  This would have allowed CMS and respected professional organizations perhaps along with the American Cancer Society to set up strict rules to follow patients who got screened for colorectal cancer with CT colonography so we could get the data, measure the effectiveness of the test, and answer the questions that have been raised.

CMS said repeatedly they couldn’t do a CED for CT colonography because it is a screening test.  They did have such a program for PET scans, but that was OK in their opinion because PET scans are used in the diagnosis and treatment of disease.

So much for preventing cancer as opposed to treating it.

There were other issues, such as how much CT colonography costs.  Truth be told, CMS knows there is no answer to that question, because they haven’t established a payment for the test.  That process is currently underway, and may now be stalled because of the agency’s decision not to cover the test.  And, more gastroenterologists are requiring their patients to have general anesthesia for a routine screening colonoscopy, which can substantially increase the costs for the procedure.

So any statements about the cost of CT colonography in comparison to routine colonoscopy is a pure guess in my opinion.

And when the experts looked at the costs of treating colorectal cancer in their cost-effectiveness analysis, they used old data that didn’t use the expense of the newer targeted therapies and other chemotherapy drugs used in treating advanced colorectal cancer.  These newer costs can quickly run into the hundreds of thousands of dollars, tilting the balance clearly in favor of screening and prevention as opposed to treatment of advanced disease.

So the argument goes on. 

In its comments released today, CMS frequently cites the lack of medical data on the use of this test in patients aged 65 and over.  With this decision today, it is likely we will never develop such data.

We need a better way in this country to find out what works and what doesn’t in medical care.  When it comes to saving lives, we have a problem when we can’t get the answers we need.  We need a system that can look at procedures that could have a major impact on saving lives and answer the questions that have been asked, rather than just dumping it on the heap of “non-coverage” to hopefully be reexamined another day, maybe within the next ten or fifteen years.

If I seem a bit angry, maybe I am.  I thought this would be the opportunity to do something right, to answer the questions that have been asked, and address a major public health need.

Goodness knows I don’t have all the answers, but I do hope that I have the common sense to understand that when there are significant disagreements by respected experts, and when the issue at hand is saving lives and saving people, that we would look beyond questionable assessments and find a path to get to the right conclusion, whatever that may be.

It’s ok to say “no,” but it is much better to say “how do we resolve the questions for our better health?” Here was a chance to do just that, and we have failed to meet the challenge.

Unfortunately, if this is a harbinger of things to come this is not a good sign for the future of reforming healthcare in this country.

I participated in a meeting convened by the Food and Drug Administration this past Monday that addressed a new program the FDA has to put in place to address problems with certain pain medicines. 

The purpose of the program—called Risk Evaluation and Mitigation Strategy, or REMS—is to deal with the two conflicting goals of adequately and effectively treating pain with powerful medicines while making certain these medicines are used as intended and don’t end up in the wrong hands causing harm. 

Depending on how this program is designed and implemented—and those decisions are a long way off—we could either enhance pain control or significantly reduce access to these medications for patients who truly need them, frequently at the end of life.

On one hand, there is the need to be certain that patients in pain have access to adequate and appropriate pain control using effective medications as safely as possible.  On the other hand, there are the legitimate concerns of the FDA, the DEA (Drug Enforcement Administration) and many, many interested organizations and others concerned about the diversion and abuse of these medicines throughout the country.

How to balance those concerns and get this “right” is going to be an interesting and—I suspect—hotly debated topic over the next months and probably years.

The cancer community—physicians, other health care professionals, patients and their caregivers—are acutely aware that we do not do a particularly good job of diagnosing and adequately treating cancer pain. 

• Part of the problem is that some patients believe that pain is part of the disease (unfortunately, it frequently is) and not much can be done to help (frequently not the case).  
• Part of the problem is that health care professionals either don’t ask or don’t listen when their patients are in pain. 
• Part of the problem is that patients don’t have access to pain medicines for various reasons. 
• Part of the problem is found in communities where pharmacies don’t stock these medicines for a variety of reasons. 
• Part of the problem is that there are some states where large areas are subject to intense controls on pain medicines because of illicit use and crime. 
• And part of the problem is that health professionals are not particularly well trained when it comes to pain control and management.

Into this morass, the FDA now must design a REMS program to target the use and abuse of certain pain medicines. 

REMS programs involve the education of patients and health care professionals on the proper use and risks of some medicines.  These programs may also include registries of doctors and patients who can prescribe and receive certain medicines.   One example is the REMS program for isotretinoin which is used to treat acne and can cause birth defects, which includes education for doctors and patients, and a registry to track those doctors who prescribe the medicine and the patients who take it.  Don’t participate in the program and you cannot legally prescribe the medicine or receive it.

The FDA did indicate this week that it is probably not going to establish a patient registry to record the names and illnesses of those patients who receive opioid medicines for pain.  But it is reasonably clear that someone is going to be charged with developing educational and registry programs for health care professionals who will be allowed to prescribe these medicines.

There were all sorts of opinions at the Monday afternoon meeting (there were actually several of these meetings Monday and Tuesday where the FDA reached out to various groups that have an interest in this topic) as to what the FDA should do, from requiring education as part of a doctor’s professional license renewal to setting up quality improvement projects in doctors’ offices to making this part of a professional specialty board recertification process.

For me, the overriding question is how do you balance the need to improve the knowledge and quality of care provided by health care professionals who treat pain with the public interest in making certain that these medicines are used appropriately as intended by those who need them and don’t end up addicting others needlessly?

If the program is too restrictive, then doctors will say the heck with it and simply not participate in the program. The result would be that patients in severe pain will have increased difficulty getting a prescription for the pain medicines they need, making the situation even more complicated than it is today. On the other hand, if the program is too easy we won’t be able to change the culture of how we evaluate and treat pain. 

Looked at in the best possible light, this is a rare opportunity to truly improve the quality of care we provide our patients. 

Maybe I am a bit “pollyanish” and too optimistic, but it would seem to me—as I mentioned at the meeting—that we have the opportunity here to bring a number of interested parties together to do something right and something good while addressing the public interest in this topic.

Already, voluntary organizations are talking to medical professional societies as to how to increase awareness of appropriate pain evaluation and treatment.  There are also various states that have implemented technology based solutions to more seamlessly and non-intrusively address the diversion and abuse issues.

As I mentioned, we are at the threshold of an opportunity to improve the quality of medical care, or simply continue to bumble along with business as usual.  Which path we take will require commitment and effort, as well as open and honest discussion.

If we succeed, we will do good.  We will improve the care we offer our patients, and save lives through a reduction in the illicit use of these drugs.

If we fail, cancer patients will suffer even more than they already do. That would be a very painful and needless tragedy.