A couple of years ago I participated in a small group discussion as part of a larger conference on the problems of getting more people to take cancer screening seriously.

During the course of that discussion the topic turned to prostate cancer early detection, a topic that I have covered previously.

I distinctly remember the comment of one of the members of the group, who happened to be the director of a large national employer based group interested in health care issues.  This representative, who happened to be very knowledgeable and very influential, was also very direct.

Her comment was to the effect that when it came to prostate cancer screening there were so many different recommendations and so much “noise” that it was confusing to her constituents, not to mention their employees as to what the right thing was to do with respect to prostate cancer screening.

Get your messages straight, she said, and then we (the employer community) will know what to do.  In the meantime, don’t blame us if we don’t seem too enthralled with encouraging prostate cancer screening.

You may or may not agree with such a blunt assessment, but it is an honest one.

Over the past several years, there has been a sea-change developing in medicine demanding that we develop evidence based information to guide the care decisions that we make for our patients.  We want to be able to provide clear, evidence-based information to our patients about what the best treatment is for their particular condition.

That’s not to say there isn’t a lot of art in the practice of medicine.  There is still much we don’t know, and there are many treatments offered to patients that have't been confirmed in well done, rigorously designed clinical trials.

Which brings me to my topic today regarding the treatment of prostate cancer.

The sad fact is that the same confusion that exists for the screening of prostate cancer applies to the treatment of prostate cancer as well.  We don't have the evidence we need to provide the clarity of message that our patients expect and want in their time of need.

There are many different ways to approach the treatment of a man who has been diagnosed with prostate cancer.  A number of variables are factored into the equation, including the man’s age, his overall health and life expectancy, and the grade, size and extent of his cancer, for example.

Then there comes the question of what type of treatment should be used.  Should it be radical surgery? With or without robotic assistance?  How about external beam radiation therapy?  Or should you have radioactive seeds implanted into the prostate?  How about a combination of both radiation types?  And what about IMRT (intensity modulated radiation therapy), which concentrates the radiation beam, allows higher doses to be administered with fewer side effects?  Or should you travel to a center that uses proton therapy which is even more focused and intense radiation?  And don’t forget the newest wrinkle, which is using CT scans on a regular basis to reposition the radiation beam.

And after you, the patient and your family, digest all of that information, there is the real decision: should you receive treatment at all?  If you are older, infirm, or have a small, low grade prostate cancer there is a reasonable probability that your prostate cancer may never bother you again.  So no treatment or “watchful waiting” may be right for you.

If you decide to receive surgery or radiation, the reality is that the treatment may in fact be worse than the disease in your particular case.

This can all be very, very confusing to someone who has just been diagnosed with prostate cancer. 

There are these days no shortages of professional, knowledgeable medical opinions available.  Unfortunately, from my experience, you usually get one recommendation from a surgeon, another from a radiation oncologist, and your family doctor probably doesn’t have the knowledge basis on which to make an absolute firm decision.

There are also databases available which may help you decide what to do.  Fortunately, some doctors are collecting the results of thousands of cases and keeping track of treatments and results.  That may give some idea of what the best treatment may be for you. 

The problem is that treatment at times can be a moving target.  For example, take robotic surgery.  There is a long history of surgery in the treatment of prostate cancer, so the doctors have a pretty good idea of what the outcomes are going to be percentage wise.  But along comes robotic surgery, and now more doctors are doing radical prostate cancer surgery.  We won’t know for many years whether or not this new technique is going to significantly impact the results in prostate cancer surgery—for better or worse.

And the radiation techniques keep changing, so we don’t have a decades long experience with any radiation treatment approach to know, again, what the long term results are going to be.

This past weekend, at a prostate conference sponsored by the American Society of Clinical Oncology in San Francisco, a new bit of information was added.

A researcher from Philadelphia examined data from a nationwide, government sponsored cancer registry called SEER which they merged with Medicare data to determine the answer to a simple question: does treatment make a difference?  Do men who receive radiation or surgery live longer having undergone some form of therapy?

Sounds somewhat elementary and simple, but recall my earlier comment that “watchful waiting” was appropriate for some men depending on their disease status and other considerations.

In this study, which examined the medical records  of nearly 50,000 men, they found that treatment (either with radiation or surgery) did in fact make a difference and that the men who were treated—even older men over 75 years of age—did better if they received some treatment.  The researchers said in their abstract that they considered whether or not there were any differences in the medical conditions of the men that might account for the difference they observed, and could find none.

The study wasn’t designed to find out whether one form of treatment was better than another.  But the data was sufficient for them to conclude, “In the absence of randomized studies comparing radical prostatectomy and radiation therapy, eligible men should be considered for (treatment).”

I don’t know that this study is going to change anything that doctors do or that I would recommend to a patient.  But it is going to increase the debate, especially about men ages 75-80 at the time of diagnosis.

There have been other studies reported recently that came to different or opposing conclusions.

One study in the Journal of the American Medical Association reported in 2004 concluded that their findings supported treatment of men with early stage prostate cancer early in the disease, especially if the man had a life expectancy over 15 years.

Another study, reported in the same journal in 2005, said that is not the case because they could in fact not find evidence that men with low grade prostate cancers showed a benefit from early treatment.   These men did not have an increased rate of death from prostate cancer if they lived more than 15 years.

So who is correct in this debate?

The reality is there is no right and wrong here.

Clearly we need to keep studying the issue and develop better information. And we need to see the abstract presentation come out in a peer reviewed medical journal so we have more information to look at and help us understand better how well the study was done and whether it should have a significant impact on how we treat our patients.

In the meantime, being informed is your best friend.  Learn what you can from your doctors, and get information from reputable web sources hosted by organizations such as the American Cancer Society, the National Cancer Institute, and the National Comprehensive Cancer Network,  where you can find both professional and patient-friendly information discussing your treatment options. 

Don’t ignore the fact that your personal physician—the person that knows you best—may be able to walk you through some of the decisions.  They may be able to help you sort out your options and what is best for you.

Ultimately, I hope that we eventually get to the point when we can find our way through the noise and the clutter.  We have done a lot of excellent work in prostate cancer over the past couple of decades.  We can find the disease earlier, and we have more men surviving prostate cancer than ever before.

But our journey is not going to be over until we are able to tell which men really need treatment, and which treatment is best for them. 

We still have a long way to go.

Not so long ago I commented on a study that demonstrated the effectiveness of a vaccine against the human papilloma virus, or HPV, that is now considered responsible for causing almost all cases of cervical cancers here in the United States and throughout the world.

What was exciting about the research report that prompted the blog entry was that the vaccine, tested in other countries in young women, was 100% effective in preventing HPV infection.  In addition, although the duration of the study was short, there was already a discernible decrease in the number of vaccinated women who developed cervical cancer compared to those women who did not.

At that time, it was apparent to most folks that the company that had sponsored the clinical trial and who had developed this particular vaccine was probably going to move quickly to get the vaccine approved by the FDA.

The company, Merck, did in fact submit a new drug application to the FDA in late 2005, and the approval process is moving forward.  Merck has recently announced that the vaccine has been given a priority review status with an anticipated decision by June 8.

Hand in hand with the approval process is another important deliberation, which is review by the Advisory Committee on Immunization Practices (ACIP) that provides guidance as to who should receive the vaccine, and when.  The opinions of this committee are crucial, since their recommendations are key in determining the population to be immunized, as well as how payment for the vaccine will be handled by various federal programs.

Organizations like the American Cancer Society are involved on another level as well, namely educating opinion leaders and the public on the vaccine, its value and effectiveness, as well as addressing some of the issues that will become front and center as this vaccine moves through the approval process.

The potential value of this vaccine is nothing short of incredible, and its impact will be significant.

Cervical cancer, fortunately, has become uncommon in the United States.  There will be about 9710 new cases diagnosed in this country in 2006, and 3700 women will die from this disease.

However, many, many more women every year will be told they have an abnormal pap smear and will have to undergo follow-up, which can vary from repeating the Pap test at a particular time, up to having surgery to remove areas of abnormal (but not cancerous) cells.  There is the possibility with some of the more advanced surgeries that a woman’s ability to carry a pregnancy to term may be adversely affected. 

This is no small matter.   An effective vaccine against the virus that causes cervical cancer has the potential over the next several decades to change the face of gynecology practice as we know it today. The total cost in health care dollars spent in this country annually for the treatment of HPV related cervical disease is $3.5 billion.  That’s a lot of money that could be used in many other areas of prevention and treatment in our health care system.

But I am getting ahead of myself.  We don’t yet have a vaccine approved for use, and we can’t say for certain when that approval is going to be forthcoming from the FDA.  The best guestimates are sometime in late spring or early summer.

If you follow this issue closely, you are probably aware that there is already considerable discussion in the media and among various groups that have an interest in this vaccine as to when vaccination should start and who should receive it. 

For now, I am going to put aside the question of whether or not young men should receive the vaccine. One of the properties of the vaccine is that it is effective against ano-genital warts, and that is a disease that afflicts both men and women. 

There is also the question of whether we can also reduce transmission of the virus by inoculating young men, who are also carriers of the HPV virus (which, by the way, is completely asymptomatic in men and women.  This is a virus that is almost universal among sexually active men and women at some time in their lives. There are many strains of the virus, just like the flu virus.  Only a couple cause cancer, and of those even fewer are responsible for most of the cancers.  The current vaccine from Merck contains virus antigens for 2 strains that cause cancer and 2 that cause warts; another vaccine, from GlaxoSmithKline, contains the 2 cancer causing strains and not the 2 that cause warts).

The experts tell me that once you are infected with an HPV virus it is too late for the vaccine to be effective.  That means that to get the results from the vaccine, it should be administered before a woman becomes sexually active. Experts are focusing on young women in their pre-teens as the most appropriate group that should be vaccinated.

The decisions made by the FDA and the ACIP are going to be very important in determining what the right age will be.  And that means it is important for parents to understand the pros and the cons of providing this vaccine for their daughters, and possibly their sons.

There are some who are concerned that the use of this vaccine may promote sexual activity among teens (which I found out recently was much greater than I had thought).  Others say it is like wearing a safety belt, in that you don’t wear a safety belt because you believe you are going to cause an accident, but rather to protect you from someone else’s carelessness.

My purpose here is not to get into the middle of that particular discussion.  But I do want to stress how important it is for everyone who is involved in the discussion, or has a child who may be a candidate for the vaccine, to learn objective, valid information about the vaccine. The American Cancer Society is one source that will have accurate information available when you want it.

Fortunately, to date, there haven’t been reports of serious side effects associated with the vaccine.  But, as I have told my colleagues, I have never seen a vaccine or a medicine that is free of side effects, no matter how good it looks in pre-release trials.  It is one thing to vaccinate a couple of thousand people as part of a study; it is quite another to vaccinate millions of folks.  Side effects are, unfortunately, part of medicine.  We can’t avoid them, and the expectation here is that we will eventually see them with this vaccine as well.  But the early reports are certainly very encouraging that this vaccine is well tolerated.

Another point that has to be kept in mind is that cervical cancer cases and deaths are higher in medically underserved women, as well as women of color to don’t have access to regular Pap tests. 

For these reasons, the HPV vaccine has the potential to be of even greater value in these communities. This requires (demands would be a better word) that we start the dialogue and educational processes now to engage these communities.  Failure to do so will once again result in suspicion and slow acceptance of what could be a life-saving vaccination. 

If we have learned anything from past mistakes, it is that community engagement and education is needed so we can work through the process together, not pronounce it one day as a fait accompli. We need to be partners in this process if we are going to achieve the potential this vaccine has to offer everyone.

We are approaching the moment of approval with anticipation, and although no one can predict whether or not any particular vaccine or medication will be approved by the FDA, we are hopeful this application will be successful. 

Merck, as noted has already submitted its NDA.  A GlaxoSmithKline representative announced at the ACIP meeting here in Atlanta yesterday that they expect their NDA to be submitted in 2006 (no additional information was available about this comment on the company’s website).

And, if FDA approval comes before the next ACIP meeting in late June, it is possible that widespread vaccination programs could be in place shortly thereafter.

Here is hoping that we have a true success on the horizon.

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I would like to acknowledge one of my colleagues here at the Society for her efforts in keeping the society current and engaged as the vaccine story has unfolded. 

Debbie Saslow, PhD is our director for breast and gynecologic cancer and is the point "science person" responsible for helping put into place much of the Society's current activities with respect to the HPV vaccines. She has done an excellent job of preparing the Society for this issue, and helping us anticipate what we need to know and what we need to do as the hoped for approval becomes a reality. 

Dr. Saslow has also provided much of the content and knowledge on which this posting is based.

This week we had another report from the Women’s Health Initiative (WHI), a federally sponsored long term study which has looked at a number of issues, such as hormones, diet and cancer prevention. 

This report, appearing in the New England Journal of Medicine, studied the value of calcium and vitamin D in the prevention of colorectal cancer. 

Last week, I was less than enthusiastic about their research report on the value of a low fat diet in reducing the risk of breast and colorectal cancer.

This week, different scenario, but the same conclusion.  

Once again, we will not have the answer to the specific question about whether or not calcium and vitamin D reduce the risk of colorectal cancer.  And this is after many, many years of study, in a research program that one of my colleagues called "the Rolls Royce of studies”.

I don’t mean to sound critical.  These are very well designed studies, by leading investigators who have contributed a heck of a lot more than their time to this effort for the past 15+ years.  These researchers are highly regarded, and are very knowledgeable. 

Sometimes, though, in science as in life, for whatever reason, situations change, knowledge changes, and new ideas need to be investigated.  When you have a study of this size and complexity you cannot change your plans or your design in mid-stream.  You have to deal with the hand you are dealt, in other words.

These women were part of a large cohort of women who were in fact able to participate in several studies at once: the value of hormone replacement therapy, the ability of a low fat diet to reduce the risks of breast and colorectal cancer, and whether taking calcium and vitamin D would reduce the risks of colorectal cancer, among other areas of medical interest. 

You have possibly heard the results of this portion of the study by now: postmenopausal women who took 1000 mg of calcium and 400 IU of vitamin D (or perhaps we should say were assigned to take those doses) did not have fewer cases of colorectal cancer than those who were given placebos, or sugar pills.

As noted in an editorial in the same issue of the New England Journal of Medicine that accompanied the research article, reducing the risk or preventing colorectal cancer is an important goal, in no small part because this cancer is the second leading cause of cancer deaths in this country. 

That translates into a lot of interest in finding a medicine, vitamin, mineral, herb or whatever (hopefully something that is simple and well tolerated with few short term and no long term side effects) that will reduce the risk of getting colorectal cancer and/or dying from it.  (Of course, this ignores the fact that if we did early detection tests that we currently have available and know work, we could reduce the number of deaths from this cancer by half.  Yes, that is correct: by half!!!!  But that is a topic for a different day.)

But as the editorial also noted, the fact that this study was “sliced and diced” (my words) into so many compartments may have in fact diminished its ability to answer the question it was designed to ask.  And, the doses of vitamin D and calcium may have been insufficient to have the desired effect, as these recommended doses (especially for vitamin D) have increased over the years.

The same basic criticism applies here as I mentioned in my blog last week on the low fat study: would you expect any intervention short of a miraculous one to reduce the risk of colorectal cancer in a group of older post-menopausal women who were followed for 7 years on average?  After all, these women were entering the prime age to develop a disease whose beginnings probably started many, many years previously.

In this paper, unlike the last one, the researchers were a bit more forthcoming in this regard.  They wrote, “If the benefit of calcium with vitamin D supplementation is to prevent or slow the progression of colorectal cancer in its early stages and if colorectal cancer has a latency of 10 to 20 years, the average intervention and follow-up of 7 years in our study may have been insufficient to demonstrate an effect.” 

In my opinion, that is a true statement.  And it was not offered in the low fat study, where the same criticism was valid. 

In contrast, there were numerous media interviews by experts who proclaimed the low fat diet was of no benefit in reducing the risk of colorectal or breast cancer based on that research report.  That may in fact be a true statement—but based on prior research, not the results of the study that was reported last week. 

As I have written previously, my colleagues tell me the evidence has been reasonably well established that a low fat diet on its own was proven years ago not to be effective in lowering the risk of colorectal and breast cancer.  In other words, to those in the scientific community, this new research report was not news.

There was an important subtext to this research that cannot be overlooked and that is the issue of vitamin D alone and colorectal cancer prevention. (See a related blog entry from early January for a more detailed discussion of this topic.)

The researchers measured the blood levels of vitamin D in participants at the start of the trial.  What they found was that women who had higher vitamin D levels in their blood test at the beginning of the trial had a significantly reduced risk of developing colorectal cancer during the course of the trial.  They also found that it didn’t make any difference which group the women were assigned to during the trial (remember, some of the women received vitamin D and calcium, and the others received sugar pills or placebos).  So, there was something about their initial vitamin D levels that was important in decreasing the chances that a particular woman would develop the disease.

Maybe the next trial should look at vitamin D as a colorectal cancer prevention strategy.  But my hunch is now that the “gold standard” trial was completed at great expense with less than clear findings, there won’t be much incentive to repeat the effort and invest the substantial cost.

So for now we will continue our confusing messages to the public about the role of calcium, vitamin D, aspirin, non-steroidal anti-inflammatory drugs, and whatever in reducing the risk of colorectal cancer.  My confession here is that even I am confused on what the evidence shows, and this study certainly did provide me any help.

As the doctors who wrote the editorial commenting on the study concluded, “Thus, the conclusion of Wactawski-Wende et al. about the role of calcium plus vitamin D supplementation in the prevention of colorectal cancer needs to be interpreted in the light of the complexities of the WHI study and the probability that the doses of these substances may have been too low to achieve the desired effect.”

I couldn’t have said it better myself.

There is some considerable excitement at the American Cancer Society.   

For the first time since 1930, when statistics measuring the number of deaths from cancer in the United States were started, the actual number of people dying from cancer decreased from one year to the next.

I think that bears repeating so it is very clear: fewer American died from cancer in 2003 than in 2002.

That is a historic milestone.

I try not to get caught up in what I refer to as the “hope and hype” cycle of reporting cancer related news and information that has been so prevalent in the past When you deal with a life threatening illness, however, it’s hard not to grab on to bits of good information and try to make them sound better than they really are.

This is no such situation, so let’s try to put it into perspective.

We have known that since the early 1990s there has been a slow, steady decline in the rates of cancer deaths. For some of the major cancers, there has been a steady decline in the rate of death from those specific cancers, such as lung and prostate cancer in men and breast and colon cancer in women. 

At the same time, for some cancers, there has been an increase in the incidence of the disease, such as breast cancer in women and prostate cancer in men.   So, although more people were getting cancer, fewer were dying from it.

The result was that the outlook for the person who developed cancer was much better today than it was in 1990.  The percentage of people alive with cancer has increased significantly.

But although the rates of cancer deaths declined, the absolute number of people dying from the disease each year in this country was increasing.

The key to appreciating why we are excited about today’s news is to understand the differences between the rate of a disease or death from the disease compared to the actual number of people dying from the disease.

A rate of disease is the number of people who develop or die from a disease per constant number, such as 50 people out of every 100,000 people will develop a particular disease.  That way, we can compare the rates in one place to another, or similarly we could compare the rate from one year to the next.

So, if there are 500,000 people in a city, we would expect 250 would develop the disease.  If 50,000 people lived in another city, we would expect 100 cases of the disease.

Let’s say our city of 500,000 souls grew to 600,000 people over one year, and the rate of our hypothetical disease decreased to 45 per 100,000.  That would mean in year #2 there would be 270 people who got the disease instead of 250.  So, the rate went down, but the number of people who became ill increased.  Although the situation looks worse by the numbers, it is actually better.

Up until now, it is the rate of death from cancer that has been falling.  That is good news.

But, since our population has been growing (more people) and getting older (more people who would be expected to get the disease since cancer is more commonly a disease of aging), the actual number of folks getting cancer and dying from it has been increasing, which seems to be bad news.

Confusing?  You bet.  That's why today's report that the actual total number of people dying from cancer is so important. 

We are no longer limited to talking about decreasing rates, but can now talk about a decrease in actual numbers of people dying from cancer.  We are, in a sense, moving forward faster to decrease the deaths from cancer than the growth in the population and the aging of the population in this country would be expected to increase that number.

Admittedly, the decrease wasn’t much.  In fact, 778 fewer men died from cancer in 2003 than in 2002, but 409 more women died of the disease.  In total numbers, there were 557,271 deaths from cancer in 2002 and 556,902 in 2003*.

That doesn’t sound like much, but it is—really.  It is the first time, as I mentioned before, that there has been an absolute decline of any magnitude in the number of people dying from cancer from one year to the next since the statistic has been collected and recorded.

This didn’t happen in a vacuum. 

I was reminded yesterday of all of the hard work put in by American Cancer Society volunteers and staff over the past decades that made this happen.

Over the past two days I was attending a meeting which brings together a large number of senior ACS staff from around the country and our National Home Office in Atlanta.

One moment in particular during our group meeting brought home the incredible dedication of our volunteers and staff. 

Many of the people in the room were medical professionals who have been with the Society for many years, even decades.

When we were discussing the news about the decrease in the number of deaths (which we had just heard), one of the people in the room started remembering all of the different initiatives that the Society had put into place over the years.  Efforts to increase Pap smears, mammograms and colorectal cancer screening among others were recalled.  And each recollection brought acknowledgement from the group in rising tones, somewhat like parishioners in church during an inspired sermon. 

These folks had participated in these efforts along with the Society’s dedicated volunteers, and now the results of those hours, weeks, months and years of effort had resulted in an accomplishment of palpable significance. There are literally millions of people over many decades whose efforts made this day possible.

There will be other milestones over the coming years that will help continue to decrease the burden of cancer.  The new vaccine to prevent transmission of the virus that causes cervical cancer is currently under review by the FDA.  We anticipate that it will not only reduce the number of cervical cancer deaths in this country and throughout the world, but also have a significant impact on gynecology care and treatment of precancerous lesions as more young women become vaccinated.

There is clearly much, much more to do. 

If you are a regular reader of this blog you have seen the comments about the need for screening to prevent and detect cancer at its earliest stages.  The need for research to develop new therapies, including targeted drugs and vaccines, continues.  We need to increase access to care, especially among our populations in need who are so vulnerable to this disease.

Probably the most important “next question” is whether we believe this decline in the number of cancer deaths will continue.

The obvious answer is that we hope so.  The honest answer is we don’t know.

We know why some cancer death rates have fallen.  For example, the lung cancer death rate for men has dropped considerably, as men have stopped smoking.  And we hope the same will occur for women.  But there is a hard core of smokers that won’t or can’t quit, and eventually the decline will level off unless we become very successful at enrolling these folks in quitline programs or other smoking cessation aids become available (there are medications under study that may have better success than those used to date).

For some cancers, we know that increased screening could bring great success in reducing the deaths from cancer.  For example, mammography can find breast cancer in most cases when it cannot be felt.  But not enough women get their mammogram every year.  For colorectal cancer, we could cut the deaths from the disease by 50% if people followed our screening guidelines.

And for some diseases, we simply don’t know why they are becoming less lethal.  Stomach cancer is one such example.

So despite the excitement, there is no rest or respite in continuing our efforts to make this report the norm and not the exception. 

If we make the commitment to do all we already know, we will see continued reduction in the absolute number of cancer deaths.  If we don’t make that commitment, then this may one isolated observation in an uphill battle.

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You may question why we are talking about deaths from cancer in 2003 compared to 2002, when we have just completed 2005.

In fact, it takes a number of years for the appropriate government agencies to compile the number of deaths in a given year and make them available.  2003 data has just been provided, and is the most current that we have.

There is little doubt that two articles and an editorial just published in JAMA about the lack of benefit of a low fat diet in reducing the risk of breast and colorectal cancer in post-menopausal women are going to make big news. 

The media is already in a frenzy, ready to trumpet the information that watching your diet, if you are a post menopausal woman, doesn’t make any difference in the chance that you will get breast or colorectal cancer.

On the other hand there are a lot of people active in the cancer prevention, epidemiologic, and nutrition communities among others, who are afraid that the message the study appears to send will derail years of efforts to get people more involved in their diets and their lifestyles as they relate to the prevention of disease.

And there are some who are wondering how we ended up with a study that has been about 15 years in the making, involved almost 50,000 women, and didn’t give us a definitive answer to a very important question.

I still recall back in the very early 1990’s, as I attended a number of medical meetings and heard the presentations from the researchers who were going to initiate a massive, government funded study of 50,000 women.

They were planning on studying hormone replacement therapy as the main objective, but there were other issues on the table as well.  The effect of diet was on the agenda, and I specifically recall wondering to myself (and occasionally asking the question of the experts in public) did they really think they were going to be able to get women to commit to this study and change their habits?

My experience in my primary care practice was not much different from many colleagues at that time.  It was just plain difficult to get people to stick to dietary interventions and maintain them for any length of time.  Rare was the person—man or woman—who made the commitment to change their diet, and stick with it long enough to make a difference.

It turned out the recruitment for the study was reasonably successful, and thousands of women were enrolled.  Many of us were anxious to hear the results, especially whether the interventions worked as planned.  Now we all have an opportunity to examine what has been the largest undertaking of its type and measure its impact and its success.

You may recall hearing about this study before.  It is the same study that several years ago led to the conclusion that routine, almost unrestricted use of hormone replacement therapy (HRT) in post-menopausal women caused more harm than good.  This report resulted in recommendations that women should stop their HRT because of the risks of continuing the treatment.

The gynecologists who cared for these women didn’t quite see it that way, and their experience suggested that there were some women who still needed HRT. 

Patterns of practice and the way hormones were prescribed did change.  But not until there were a number of questions raised about the fact that the average age of the women on the study was north of 60 years old—not exactly the type of woman you would want to start on hormones in the first place if she didn’t require them previously.

The result was that in a number of meetings I attended with my gynecologist wife I heard critic after critic claim that, for this reason among others, the study was not applicable to standard practice.  The experts called into question the value of the study in terms of assessing the risks and benefits of HRT for the usual woman.

So what did the current studies about the role of low fat diets in reducing the risks of breast and colorectal cancer find? 

There were actually two reports on cancer (and a third on heart disease, but I will leave that to others to discuss).

The women who participated in the study were randomly assigned to continue a regular diet, or begin a program to reduce their dietary fat intake to 20% of their daily calorie intake, increase their intake of fruits and vegetables, and eat more servings of grains on a daily basis.  Reducing food intake and losing weight were not goals of the study.

The women in the “control” group did not have any further discussions or meetings about their diets, while the women in the intervention group were counseled on a regular basis and encouraged to maintain their dietary intervention program over the course of the study.

The women who were advised about their diet did in fact lower their fat intake, but not as much as the researchers had hoped.  And they did increase their fruit, vegetable and grain intakes, although the degree of success varied over the time of the study.

The results of  having a group of women commit to a low fat diet program was that, after being followed for an average of about 8 years, there was no detectable difference in the risk of getting colorectal cancer or breast cancer. 

(It should be noted that in the breast cancer group the data suggest that perhaps with additional follow-up over time there may be a benefit of the low fat diet in reducing the risk of breast cancer.  But as of right now, the researchers could not conclude with certainty that there is a real difference present.)

The women in the study group had lost a small amount of weight compared to the control group. But, as the authors noted, weight loss was not the goal of the study. 

Now let’s ask the obvious question: if you took a group of women where about 12,000 out of about 19,000 in the study group were age 60 and over (up to age 79), and you put them on a low fat diet, would you expect to see an effect in either breast or colorectal cancer incidence?  Would you expect them to adhere for a long time to a diet that was very low in fat content?

And, if you followed these women for about 8 years, knowing that colorectal cancer in the usual case takes about 10 years to develop from a polyp to a cancer and probably starts well before that time, would you expect to see a benefit? 

The same questions can be asked about breast cancer, which is a disease that increases with age, but probably starts many years before it is detected by mammography.

That’s the problem we face in interpreting this study and assessing its implications and its impact.

My colleagues here at the American Cancer Society have made the point to me that we have not been enamored of the theory that fact intake is related to either breast or colorectal cancer for some time.  And there has been some question as to whether fruits and vegetables make a difference in breast cancer. 

These were questions when the study was conceived, but research over time has indicated that they are probably not a primary factor in the development of the diseases under study.

We have been fans of advising women to maintain a healthy body weight, and exercising regularly, both of which are associated with decreased rates of colorectal and breast cancer.  There is nothing in this study that goes against these recommendations.

And, in a study published in 2003 in the New England Journal of Medicine, researchers from the American Cancer Society clearly pointed out the relationship between obesity and a number of cancers, including breast and colorectal cancer.

So, what we knew then and what we know now has changed.  It is important that we keep this perspective in mind as we evaluate these reports.

The current study, according to my colleagues and I suspect others as well, is not going to have us change our guidelines or our public guidance on this subject.  And there may be criticisms that for reasons beyond the investigators’ control the group that was studied may have been too old to have derived any benefit from the low fat diet.

There is, unfortunately, the potential that there may be some unintended harm that comes from this report, namely that women may abandon a healthy diet and the need to maintain a healthy body weight as part of a comprehensive cancer (and other disease) prevention program.

If that occurs, and if that is the message the media carries, then a well done, well intentioned, well written scientific report may result in some unfortunate consequences.

Hopefully, we won’t end up with misunderstandings about some very important recommendations about what we need to do to reduce the risk and burden of cancer in ourselves and in our communities.

So, you are not off the hook.  Following a healthy diet, getting regular exercise and maintaining a healthy weight are still the rule of the day.

 Sorry about that (Well, maybe not so sorry).

Every year the American Cancer Society releases an update to our guidelines for the prevention and early detection of cancer in our journal CA: A Cancer Journal for Clinicians, and this year is no different.

As far as our guidelines are concerned, there are no new or revised guidelines this year. 

But there are some interesting bits of information in the text of the article that bear emphasis, if for no other reason than they provide a “state of the nation” on where we are with respect to how well we are doing getting folks screened for cancer.

When you look at the data as to how many people are getting screened for cancer, you can see that we do a pretty good job of screening women for cervical cancer, and not so good for colorectal cancer.  You can also see that for some cancers, in particular breast cancer, the screening rates have actually decreased a bit for reasons that are not clear.

My colleagues who are the experts in this area tell me they aren’t certain if this is a leveling off for mammography, or reflects an actual trend downwards.  Either situation, however, is not good.

Mammography as a service is under pressure.  There are some quality issues that have been raised, and fewer radiologists are becoming specialists in mammography.  There are fewer sites available around the country where a woman can get a mammogram.  Women may be coming complacent about getting screened every 12 months.

All of these are important, but there may be more significant issues at play as well.

As noted in the article, there are two paramount conditions that increase screening for cancer.  One is having a doctor or health care provider say that getting screened for cancer is something that is important for your health.  This goes hand-in-hand with having a “medical home,” that is a doctor, a clinic or a practice that you can identify as your regular source of medical care. 

The other condition is having health insurance.  As shown in the tables in the articles, people without health insurance have a very low rate of screening. 

And, although there are federal programs to provide mammograms and cervical cancer screening to underserved women, there aren’t enough funds to provide this service to every eligible woman in this country.

There may be some other more subtle factors at work here as well.

For example, I suspect many of my primary care doctor colleagues (for whom I have great respect and admiration) have “prevention fatigue.”  They forget how important their recommendation is to their patients.  So, they either don’t make the recommendation to get screened, or if they do, they don’t put the “oomph” behind it that would send the signal to the patient that this is something they need to do.

Another reason is that much of our health care in this country is episodic and opportunistic.  That means you go see the doctor when you have a problem, but don’t go when you don’t. 

The annual physical that was so much a part of my practice and my medical upbringing back in the 1970’s has been basically put out of business for many folks.  There are many reasons for that, but the bottom line is that when you see the primary care doc these days you probably have a problem, have 7-10 minutes to review that problem, and then may or may not see them again depending on what the problem is. 

There really is no time—and no payment—for the doctor to talk to you about preventive health care.

That leads me to another thought: we live in a health care environment that emphasizes illness, not health and prevention.  Our entire system for the most part is geared to getting you well, not keeping you there in the first place.

Wellness is a frustrating business for the doctor.  I know, because I have “been there, done that.”  I hate to say this, but as a doctor you don’t do well (financially) by keeping people well (unless you own one of those high end prevention clinics).  The more illness you treat, the more surgery you perform, the more x-rays you do, the better off you are.

I started off my professional career as a full time medical oncologist.  For several reasons, I shifted over into primary care internal medicine after a little over a decade as an oncologist.

One of the reasons I changed my practice was that I wanted to carry the message of health to my patients.  Don’t smoke, eat right, keep off the weight—you are probably familiar with the drill. I believed in treating hypertension first with a diet (which would work for most folks if they could stick to it).   Ditto for early diabetes and elevated cholesterol.

So how did it work?  Let’s just say that despite my best efforts and patients that were hard working, committed people, there were only a handful that could sustain a genuine long term commitment to losing weight and altering their diet.

I had a bit better luck convincing people to get screened for cancer, based on the knowledge and recommendations that were known at that time.

If we fast forward to today, my suspicion is that patients are better informed, but there are so many other things “on their plates”, so to speak, that getting screened just doesn’t rise to the top of their “to do” list.  It is difficult to take the time, pay the money and go through the process of getting screened for several cancers where recommendations exist.

And then there are the recommendations themselves.  They are not easy to understand for many people and many doctors for that matter.

I did a spot on ABC News Now with Tim Johnson yesterday (this is a subscription service, and I cannot provide a link directly to the interview).  We had plenty of time to discuss the issue about screening for cancer.  But when it came to saying what needed to be done for each cancer, there was no way we could provide all of the pertinent information. 

I think we did a pretty good job of getting some basic information to the viewers (Dr. Tim is excellent at this).  We made the point that you should consult with your doctor (I hope your doctor knows the current recommendations).  We also said you could call the Cancer Society (800 ACS 2345) or go to our website at www.cancer.org for more detailed information (information on guidelines and prevention is found on another location on the website). 

But, even if you do that, I doubt that many folks would be able to recall all of the information and nuances in the guidelines, let alone realize that there are special situations for certain people at higher risk for certain cancers.

Which brings me back to the central point of this discussion:  We could do a much, much better job of helping people through this process.  We could develop reminder systems, as suggested by the authors of the CA article noted above.  We could improve data collection so we can really tell whether or not people are getting screened and monitor our progress in something close to real time (once again as suggested in the article).

What we really need is a national commitment to health that is data and information driven, backed up by public messaging and reinforced by commitments of medical professionals, their associations, the voluntary non-profit health organizations (such as the American Cancer Society), government, insurers and the business community.  We need to get people screened and keep them healthy.

I suspect I am dreaming.  But the enormity of the task should not be a barrier to getting started on turning around our attitudes about health.

As we age, we are vulnerable.  It behooves us to understand that, and work on our health before the proverbial horse gets out of the barn.  We can take charge of our lives.  But it takes commitment, and these days it seems especially difficult to take on that responsibility for ourselves when so many others are making their demands and entreaties for our time and our attention.

Do yourself a favor, and take charge of your health now, before it’s too late.  Whether it’s screening for cancer, losing some weight or eating right—do it now. 

Prove my skepticism is misplaced, please!!!!