"There's more to it of course, but I wanted to give the flavor of the choices you can be faced with way before you think you'll need to."

That, my friends, is a message from Curt.  Read it carefully, because it is a message from a young man who is facing a circumstance that none of us ever want to contemplate.  His need to make decisions about his life and death came upon him without warning at a time when no one would have ever expected this to happen.

I don't know Curt personally.  I have "met" him through a good friend and colleague, who in turn was concerned about his good friend who suddenly found himself facing his mortality.  Otis Brawley-who is the American Cancer Society's chief medical officer-and I were consulted several times to provide advice to Curt and his wife during his time of need.

Curt is a young man with a loving, concerned wife and family who had just started a new job which I suspect he was looking forward to with enthusiasm.  He had been engaged in this new position for about a month when suddenly one day he had a seizure and was taken to the emergency room.

The doctors treated the immediate medical problem, but then did their initial evaluation and delivered terrible news: it looked like cancer had spread throughout Curt's body, with hundreds of tumors in his brain, his lungs, his liver and probably elsewhere.

The seizures were stabilized, treatment was started.  More complications came quickly thereafter, and then Curt-in a time of lucidity-had to make the ultimate decision:  whether or not to continue his treatment, or pursue care with comfort.

Curt wrote a blog, and this was his entry (reprinted with permission):

"Real Life (and Death) Choices

Posted by Curt Ewald on August 26, 2010 at 12:38pm

"Sudden New Situation: Aggressive blood-clots in both legs and both lungs that will eventually cause breathing to get worse and worse. The lung clots will kill me in days or weeks.

"Choice A: Start blood thinners to help the lung clots dissolve, but will surely cause bleeding of my brain mets and a seizure-filled, painful death experience for the kids/family. Oncologist says he has never seen so many brain mets in a single patient (100's)

"Choice B: Switch to a "comfort & care" approach in a professional home hospice environment that is already proven and I like & trust. Choose DNR status and make it clear we're not going back to the hospital. Install a little cage (already done) in my blood vessel to catch any more clots rising from the leg. This is not giving up, it's managing the death process.

"BTW - Pain relief is very well covered. I get to play with morphine, marijuana and anything else that helps!

"There's more to it of course, but I wanted to give the flavor of the choices you can be faced with way before you think you'll need to."

When I read this blog, I stopped for several minutes and just stared, contemplating its power and its guidance, coming from someone whose life had so shortly before been so promising, and was now so mortal.

Perhaps you will be as impacted by Curt's words as I have been.  But if I had my wish, I would want everyone to contemplate Curt's message, especially that last sentence.  It's worth reading again:

"I wanted to give the flavor of the choices you can be faced with way before you think you'll need to."

Curt is now sedated, and probably unable to say much.  But his words are profound, his message from the heart, and in this moment of sorrow for Curt and his family, perhaps there is solace in his words for others who have-and who will-face their own mortality at a moment when it is least expected.

Thank you, Curt.  You are in our thoughts and prayers.

If a study in the current issue of the New England Journal of Medicine was a report about a new treatment that extended the lives of patients with advanced lung cancer by almost 3 months, the crowds would be cheering.  But it isn't a study of a new chemotherapy drug, targeted therapy or vaccine.  And I doubt there are lots of cheers in the audience.

It's much simpler than an expensive, complicated new treatment for a devastating disease.  It's about starting palliative care to help patients deal with the symptoms from their disease and its treatment early in the course of that disease leading to a dramatic improvement in survival in a cancer that is almost always fatal.

Non-small cell lung cancer is a killer for many people.  Lung cancer is the leading cause of cancer death in this country, although the numbers are declining with the decrease in smoking, especially among men.  But once diagnosed as having spread outside the primary area of the cancer, the outlook is grim and for most folks is less than one year.

That one year is difficult enough knowing that you have a fatal illness.  But the treatments for the disease-and the disease itself-can be devastating.  Those treatments may buy a couple of months, but there is no dramatic impact for most people and the inevitable outcome can't be avoided.

Couple that very sad fact with the other reality that we don't do much in this country to help people through the process.  Dealing with pain, treatments, nausea, vomiting, weight loss-the common effects of cancer treatment and the illness-is very difficult under the best of circumstances.  And these folks-since they have usually (but not always) been smokers for much of their lives-have other serious medical problems with their hearts and lungs which complicates the situation further.

Palliative care is designed to help people and their families address these symptoms, along with the other issues that come along with a diagnosis of a fatal cancer.  How to make the right medical decision for the individual is one example.  What about end-of-life care, and whether or not they want to be aggressively treated with chemotherapy and even resuscitated if they should stop breathing or their heart stop functioning?  When is the best time to seek hospice care? What are the advantages and disadvantages of continuing chemotherapy in the face a relentless progression of the cancer?

These are some of the issues that palliative care teams-composed of doctors, nurses, social workers, dietitians and other professionals-can address with patient and families.  In fact, according to the article, over 80% of large (greater than 300 bed) hospitals in this country have such teams.  But unfortunately for the most part these teams don't get called in to help until very late-and maybe too late-in the course of the illness.

The study reported in the New England Journal addressed the question of whether or not calling in the palliative care team to help patients and their families early in the course of treatment made a difference compared to what usually is done, which frequently means a consultation when a patient is in great pain, severely depressed, or near the end of life.

The researchers found that by engaging the palliative care experts early on made a substantial difference in the quality of life of the patients. 

Those patients who received early palliative care had a better quality of life, less depression, and most remarkably lived 2.7 months longer than those who had routine care (it is important to point out that all patients in the study, including those who received early palliative care and those who did not, were treated by the same group of doctors and had the same access to chemotherapy treatments).  The net difference was 11.6 months for the palliative care patients, compared to 8.9 months median survival (that means half lived less and half lived more) for those patients not receiving the early palliative care intervention.  This improvement occurred despite the fact that the palliative care patients had less aggressive care at the end of life.

If that degree of improvement in life expectancy was seen in a clinical trial looking at survival after treatment with a new chemotherapy drug, there would be applause all over the place.  Instead, I fear that many physicians will just yawn and say something to the effect of "Here they go again with that pain stuff."

How did this simple, straightforward approach result in such a remarkable outcome?  The answer is that no one is really certain.

Years ago, there was a genuine question as to whether or not chemotherapy made any benefit in the outlook for patients with non-small cell lung cancer that had spread through the body. 

It took a number of years of research and clinical trials to come to the conclusion that chemotherapy did in fact improve survival for patients with this disease.  It took more years to determine that we didn't have to throw every drug we knew worked in lung cancer at our patients in order to lengthen their days.   Yet even though the treatments have been shown to have genuine value and increase survival, they come with a huge price in side effects and quality of life.  And, we still remain hugely frustrated as patients, families and doctors at the lack of a true breakthrough in the treatment of metastatic lung cancer.

Now, along comes a study that says if we just paid a bit more attention to our patients' symptoms, offered them more support, answered their questions about their treatment options, and helped them plan for their near-term future and outcome by understanding their wishes and respecting their decisions, and give that care in addition to standard chemotherapy, then we could significantly improve and prolong their lives.

This is not an especially expensive approach to medical care, my friends. 

The investment in palliative care certainly pales in comparison to the costs of the drugs we use in treating cancer, and lung cancer in particular.  But the returns on that investment-at least according to this study and a recent exellent article in The New Yorker magazine by Atul Gawande--are obviously immense.

Maybe it's time to realize that with all of our powerful medicines and other treatments we still have one medicine that we don't utilize often enough, and that is genuine caring and support for someone in distress.

As a young physician years ago, I learned to never underestimate the impact of a healing hand, a willingness to listen and an opportunity to provide support and guidance. It can truly make a world of difference. 

This study shows that rediscovering the value of what we used to do before we were able to do what we can do is a lesson well worth relearning. 

There they go again, trying to ruin my day.  The "they" in question are my epidemiology colleagues down the hall at our American Cancer Society offices in Atlanta. 

The topic a couple of weeks ago that got me going was an article they published suggesting that I had a higher chance of premature death because I sit at a desk most of the day.  Today's "offense" was a report published in the Archives of Internal Medicine showing that the larger your waist size-for the most part, with a couple of exceptions-the greater your chance of premature death.  And even if your body mass index (BMI) was normal-which is a measure of your height relative to your weight, and is used to classify people as normal, overweight or obese-you could still have an increased chance of death if your paunch is, uh, oversized.

The study has garnered a lot of media attention, probably because of the increasing concern surrounding the impact of obesity in this country. 

As noted by the researchers, this is not a new topic.  We have known for some time that an increased waist size-40 inches for men and 35 for women-is associated with poorer health outcomes.  The reason for this isn't clear, but there is increasing evidence linking a number of chronic illnesses--including cancer, diabetes and heart disease to name a few-with increased abdominal fat. 

There is reason to believe that fat stored in our abdomens has a worse impact on health compared to fat stored elsewhere.  So if you are a man or a woman shaped like an apple-carrying your weight around your middle--you are worse off healthwise compared to a man or a woman shaped like a pear, where you carry your weight mostly around your hips (as you might have observed, men are more likely to be apples, while women are more likely to be pears).

In this report, the researchers examined information that has been collected for many years as part of an American Cancer Society research program called Cancer Prevention Study II Nutrition Cohort.  They were able to examine records from about 105,000 men and women, including about 14,600 people who died from 1997 and 2006.

They found that-after adjusting for body mass index-that the larger your waist the more likely you were to die prematurely.  In fact, the risk of death for people with very large waists was about doubled.  The disturbing finding was that even if you had a normal BMI-which means that you would not be considered overweight or obese-the larger your waist, the greater your chances of early death. Larger waist size was more related to increased deaths from respiratory disease than cardiovascular disease and cancer.

This isn't the first time researchers have looked at this question of waist size in relation to chances of early death.  There have been other studies, but this one looked at people with very large waists unlike some of the previous reports.  This study also appears to be the first one that looked at the impact of waist size within each of three categories of BMI, including normal, overweight and obese.

The reason that is so important is because this study shows that you can have a normal BMI, be told by your doctor that your weight is "fine," but be at increased risk of death since your weight is carried right there around your midsection. 

One other point of note: for men, the impact of waist size on death was greater for men 70 years and older compared to men under the age of 70.  For women, age did not have as much of an impact on the results of the study.

Why am I so concerned about the results of this study?  You may have already guessed: my waist hovers around 40 inches, give a couple of pounds or so.  Eat too much, waist goes up; starve a bit, waist comes down.  The center point is right there around the magical 40 inches.

Now, I would also offer the thought that a waist of 40 inches on a man (I would never, never, never comment about a waist of 40 inches on women) can mean different things in different settings.

Take for example my experience a couple of years ago when I was looking for a pair of blue jeans.  I am one of those tall guys with a 40 inch waist.  I quickly discovered shortly after moving down South that there were plenty of jeans that would fit me with respect to the 40 inch waist, or 42 or 44 for that matter.  It was the length that was a problem.  They were all 30 inches or less in the inseam.

Travelling to the west-I think it was Texas or Arizona-I walked into one of those Western wear stores looking for another pair of blue jeans.  Now I was in luck-lots of long inseams.  But the waist size?  Try 36 and under.

The moral of the story?  I figure that there are a lot of men in my hometown who are a bit on the short size with large waists, while out West they are more likely tall with smaller waists.

Based on today's report, the Western guys are probably better off than the Southern guys-even if their body mass index is normal (which is not likely with a 44 inch waist and a 30 inch inseam).

So ladies and gentleman, you now have something else to worry about when you think about your health.  The size of your waist is likely directly related to the length of your years.  And if you take comfort that your weight in your 70's is the same as it was in college, forget about it.  The chances are your body has simply redistributed itself into the wrong places, and put you at greater risk of death.  No comfort is available anymore to those who looked the other way as their muscles turned into fat while their weight remained steady.

As to my friendly research colleagues here at the American Cancer Society, I can't wait to see what piece of information they are going to analyze next.  I suspect they have plenty of things to study that will not make my day (and maybe yours) any better. So far-in one month alone--they are two for two. 

So, my congratulations to my colleagues on producing some interesting and timely research reports. I may not like what they tell me, but what they tell me is based on high quality evidence and research.  It's up to me (and you) to take the messages and incorporate them into our everyday lives.

In the meantime can we get something positive for a change, like maybe ice cream is good for your health?  Now, that would be something to talk about.

1)The son in law came in at 1:35, #11 in his class.

2) The wife came in at around 2:35, but she did finish after walking a portion of the 5k run at the end.  And just finishing was a terrific accomplishment in our eyes.

3) The 19 yo daughter finished around 2:25, running strong at the end. She won 3rd place in her group.  There were only 3 entrants.

4) The real hero was in the 15 yo son. He is in good shape and was doing well until the final run when he developed terrible leg cramps. He had to walk the entire 5k, part of it "straight legged" and the last 1/2 mile limping severely. He made it across the finish line--unassisted--at 2:56, which was 4 minutes before he would have been disqualified. He got a second place award, since there were only two entrants in his age class. He showed incredbile determination.  We are very proud of him.

A lot of experts write and talk about getting more exercise and making the commitment to a healthier lifestyle.  I am one of those folks who think staying active is important, especially as we get older.

But there are many out there who just can't seem to get it done.  One excuse or another, whether it is time, work, travel or other obligations-whatever, we just can't seem to get where we need to be when it comes to our health.

So forgive me while I take a personal moment to share with you my pride and admiration of someone very close to me who has made that commitment for the sake of her health and well-being to do something special, something they never dreamed they would be able to do.

As I write this, it is a little before 6AM on Sunday morning.  I have just dropped my wife and family off at the starting point of one of those mini-triathalon types of races.  My wife has never done one, and never thought she would.  Today, she is on her way to achieving her goal of completing one of these races, along with the support of her family and friends, some of whom are right beside her competing in the same race.

Sandra reached one of those milestone birthdays earlier this month (she probably doesn't want me to tell the world, so I will leave you guessing which one it is.  Hint: not the first one, and not the last one.  Sort of in-between.)  We have a friend here in north Georgia who challenged her a couple of months ago to celebrate her milestone by competing in this race, and my wife took up the challenge.

So it was "off to the races" so to speak, including getting a bike, learning about the race and training as often as possible.  It wasn't easy, and it certainly wasn't convenient.  It helped that our north Georgia friend and our son-in-law had done it before, so they became not only coaches but reservoirs of information about how to do this insane event. And, as she competes in today's race, her son, daughter and son-in-law will be in there with her, supporting her in her quest.  (Not to mention the other family members and me who will be greeting her as she crosses the finish line, whenever that may be.)

The "official" race is going to start in about an hour.  But my wife has already won the race as far as I am concerned.  She made the effort, she trained whenever she could (within the confines of a very busy schedule as a practicing doctor), and now she is ready to go.  She kept her promise to herself.

But this tale is not only about my wife and about today's race.  As I said, in my heart, she has already won.  Hopefully she will finish the race, which will be victory itself.  She isn't out there to actually win this race, and we all know she certainly won't be in the top 10.  The real victory is making the effort, keeping the commitment, and fulfilling the promise and the dream.

Now, let's take a moment to let me share with you my thoughts about why I think this story could mean to you and the significant people in your life, and why I wanted to share it with you.

You don't have to participate in a triatholon to be a winner.  Maybe for you your victory will be taking the time every day to walk a little further, to eat a little better, to do something different that is positive for your health.  It is the act of doing something special for yourself-maybe something you never thought you could do.  That can be your commitment, that can be your "race", and that can be your victory.

And maybe-just maybe--if you set your own goals, you too can achieve your dreams.  I know my wife already has, and the starting gun hasn't even sounded.

Good luck!

PS: For those of you who may be interested, the American Cancer Society sponsors endurance events through DetermiNation events.  If you are an endurance athlete--or want to be--this may be a way to meet your personal goals while helping support the programs of the American Cancer Society.

It's off to the North Georgia mountains to spend some time celebrating family, friends and birthdays (July was a prolific month in our family).  Will be back August 2.

In the meantime, be well and be safe. 

Dr. Len

 Yes, this is me doing what I love to do: barbecuing (my friends picked this picture as one of their favorites).  Maybe we'll throw in a little fishing also.

In early June I appeared on a nationwide news show and in a very brief comment indicated that I thought a new approach to radiation therapy in the treatment of primary breast cancer was "not ready for prime time."  Subsequently, later in the month, I wrote a blog on the treatment-called TARGIT-where I further outlined my concerns.  My primary issue-among some other more technical matters--were that the results of the trial were being promoted to suggest that the treatment was "ready" for moving into clinical use.  I wasn't so certain.

During this period of time, I was contacted by someone affiliated with the company that manufacturers the machine used to deliver the radiation, and offered an opportunity to have a discussion with some of the researchers involved in the clinical trials of TARGIT.  We accepted their offer.

Last week we had our follow-up call, and I think now is a good time to offer some information regarding that discussion.

First, let me briefly summarize what this is all about.

Radiation therapy to the whole breast after surgery has been a mainstay of "breast conserving treatment" for women with breast cancer for many years.  It has allowed doctors to offer women a lumpectomy-assuming the tumor is a reasonable size-at the time of primary treatment, followed by a multiple week course of radiation therapy.

The radiation therapy in this situation is designed to reduce the risk of local recurrence of the breast cancer, and also to essentially "pre-treat" any other small areas of cancer that may be lurking elsewhere in the breast.  This treatment approach has proven successful, and reasonable estimates are that about 5-6% of the women treated in this fashion may eventually have a recurrence of the cancer in the treated breast, or perhaps develop a new cancer some time afterwards.  That means that the vast majority of women with early stage breast cancer do well after lumpectomy and radiation therapy, with respect to the breast where the initial cancer was diagnosed and treated.

There have been efforts over the past number of years to simplify the radiation therapy for these women with breast cancer.  Going back and forth to the radiation center over a 6 or 7 week period of time isn't easy for most women, and impossible for some women who may be disabled, not have transportation or live a great distance from a radiation therapy center.

As a result, alternate approaches have been tried which either give the radiation over a shorter period of time, or use devices placed at the time of surgery which can give the radiation more efficiently or quickly, usually over about a week.  The result is that there has been considerable discussion within the medical community over the use of what is called "partial breast radiation," with some doctors using it routinely and others waiting for the results of clinical trials which are currently underway.

The TARGIT treatment takes a somewhat different approach.  The treatment itself is again reasonably straightforward, and certainly a lot simpler than traditional radiation therapy in breast cancer.

A women has the cancerous lump removed, and at the time of surgery the TARGIT device-which generates a fairly low level radiation output compared to standard radiation therapy machines-is placed in the site from where the tumor has just been taken out.  The radiation is given over a fairly short period of time, as a single dose.  After the radiation is administered and while the woman is on the operating table, the surgeon comes back and finishes the operation.  That's it. No more radiation is needed for many women, or so the press releases and news reports seemed to indicate.

That's where I started to have some concerns.  It was my impression that the reports on TARGIT were underemphasizing the fact that a fair number of women (my rough "back of the envelope" estimate was 22%) who received TARGIT during primary surgery would still have to go on and get whole breast radiation.  This was as a result of having more aggressive cancers that the researchers felt would benefit from more intensive treatment.  The problem is that for many women, the doctors couldn't know their cancers were more aggressive until looking at the cancer under the microscope.  And that usually doesn't happen until after the cancer has been removed and the TARGIT treatment given (there is an alternate approach, but I don't want to repeat here what I have already written in my earlier blog).

Turns out I wasn't far off.  The researchers on the phone call agreed that 22% was not an unreasonable number.  They agreed that somewhere between 20 and 25% of the women treated with TARGIT in the manner that would probably be the routine practice in the United States would still have to go on to get the traditional radiation therapy over several weeks.  But they also emphasized that 75-80% would not.

The other observation that I made in my blog was that this was a group of women who had what we call "favorable" breast cancers.  That is, in many of the women the cancers were fairly small, were hormone sensitive, and lymph nodes were not involved. 

Again, the researchers on the call agreed.  Having such a "select" group of women with more favorable breast cancer was not their intent at the beginning of the trial-as reported in their research paper in the Lancet-but that's the way it worked out, for a number of reasons.  They agreed that the results of their trial could not be used to support the use of TARGIT in breast cancer patients who may have larger cancers or other signs of more serious disease.

Perhaps the most contentious issue is whether or not TARGIT is ready for routine deployment as a treatment for breast cancer in this country.  In fact, one of the investigators on the call indicated that he was preparing to routinely offer TARGIT treatment for his patients with breast cancer who met the criteria discussed above.

That is still an area where I am not quite comfortable.  The researchers make an excellent argument that they have treated enough women over a sufficient period of time to conclude that the treatment is most likely effective.  However, there is a long "tradition" of treating early stage breast cancer with whole breast radiation and changing that pattern of care takes very solid evidence-especially since the use of whole breast radiation has been based on prior clinical trial results which are widely accepted and have withstood the test of time.

Please understand that I am not saying that just because we have always done something means we should continue doing it the same way forever,   If the evidence is good, then we should change what we are doing.  But we shouldn't be quick to abandon a treatment that was built on a foundation of evidence and has proven successful for so many years just because a new gadget comes along.  We need to be certain the new approach really works.

In the background of this discussion is the fact that we don't regulate machines that treat patients the same way we regulate medicines used to treat patients.

The FDA has very strict criteria when it comes to approving medicines to treat cancer and other diseases (as reflected in the Avastin® discussion earlier this week).  For drugs, companies have to prove both safety and efficacy.  For machines, safety and performance-but not necessarily efficacy-are the criteria used for approval.  So, there is no process by which the FDA reviews the data and deems the machine effective for use in treating patients with cancer.

It would be great to hear some of the discussions of experts in breast cancer regarding their views on the adequacy of this new TARGIT approach.  That might help inform all of us as to whether or not the data are sufficient and compelling to warrant making TARGIT available to more women.

For now, I suspect I am going to remain a bit more conservative and say that a couple of more years of follow-up would be helpful (although the trial has been ongoing for over 10 years, the number of women who have been entered into the trial have increased considerably over just the past couple of years, so the majority have not been followed for a very long time).  But I will admit that I am willing to listen to the thoughts of others more expert than I, assuming they do not have a personal interest (financial or otherwise) in this debate.

My bottom line?

The conversation with the researchers was worthwhile, and they acknowledged the validity of some of my concerns-which in fact they had done in their research report, but had not made it into the press releases that accompanied the presentation of the report at the cancer meetings in early June. 

I think the most important issue is that women understand that just because they get TARGIT during their surgery, doesn't mean they don't have a fair chance of still requiring whole breast radiation over several weeks if their cancer appears more aggressive when examined under the microscope.

Where we disagree is whether the data is adequate to offer TARGIT as a standard treatment for small, early stage breast cancers at this time.  I am not certain it is, but willing to listen to the thoughts of others.  What I don't want to have happen is see this treatment (or any other treatment, for that matter) "bootstrapped" into legitimacy, where doctors say they think it works often enough that they believe it works rather relying on the evidence that it works.

Time will tell the outcome of this discussion, but I do think if the trial data remains the same as it is today, and we have a couple of more years of follow-up, it is likely that TARGIT may well become a routine treatment option.  And for the women with breast cancer who wouldn't have to come back and forth over weeks for their radiation that would be a huge step forward in the treatment of this disease.

We shall see...

Sometimes you just can't get a break...

That's the way I feel after reading an article my colleagues from the American Cancer Society and other experts wrote in today's edition of the American Journal of Epidemiology.  The topic? The relationship between the time you spend sitting during the day and your chances of premature death.

The bottom line? If you sit all day, you are in real trouble even if you exercise regularly.  For those of us who try to exercise regularly, it's possibly one of the most discouraging reports I have read in a long time.

Let's get personal for a moment. 

If you follow this blog, you know that I have had a life long battle with weight.   One of the keystones of trying to keep my body under control (my genes notwithstanding) has been to exercise regularly.  I am pretty good at the commitment-most of the time-especially if I am working from my office as opposed to "road warrioring" around the country.  But when I work from the office, it is not unusual for me to spend 8-10 hours a day sitting on my you-know-what. 

OK, so there are the occasional walks to get a cup of coffee or whatever.  But the rest of my day is spent looking at a computer on my desk and trying to make some sense out of the world around me.

Then there is my "leisure time" at home.  Usually, it's about 2 or 3 hours at the end of the day, including dinner and watching some television before it's off to bed and starting another day.  Stuck in between all of this excitement is hopefully an hour a day plus/minus on a Precor machine, trying to get my daily step total over 10,000 (I wear a pedometer to keep me honest).

Now, I thought I was doing myself some good with the exercise thing.  Exercise helps me feel better and helps control my weight (doesn't seem to take it off, however.  That relies mainly on eating less, which is sometimes difficult to do).  Exercise also makes me feel that I have been doing something for my overall health, or at least that's what I thought the research has been telling me: more exercise leads to better health, and less risk of bad diseases like diabetes, heart disease, cancer, and so on.

So what did my dear colleagues write that has me so upset?

They noted that current public health guidelines say a lot about increasing physical activity but don't say much about sitting around watching TV, or working on the computer. 

Since they are the excellent researchers that they are, they decided to study the question by examining data in our CPS II cohort, which has followed 1.2 million people since 1982.  Of that group, they had detailed activity information on about 123,000 people.  Then, they carefully examined how much physical activity those folks had on a regular basis along with how much time they sat during the day, and compared that to their risk of death from any cause.

They found that men and women who spent the least time sitting around were thinner, less likely to be smokers, more likely to be employed, and ate less.  People in this large group didn't do a lot of strenuous activity.  For the most part, walking was their exercise of choice.

The researchers reported that there was a direct relationship between leisure time sitting and a higher risk of death, more so in women than men.  And, for physical activity, the more you exercised the lower your chances of death.

However (and this is the big "however" that has me so upset), time spent sitting trumped physical activity when you looked at the impact of both of these factors together.  So no matter that you were physically active, the longer you sat the greater the chances you would die.  When I looked at numbers that would characterize me (sitting more than 6 hours a day, exercising about 35 "met hours" a week), my increased risk of death is about 23%.

I wouldn't exactly call that news to brighten your day.

Maybe I should rethink my philosophy about how much I prefer to be able to sit in my office rather than travelling on the road. 

Truth be told, I spend a lot of time travelling.  Granted, much of that time is spent sitting on an airplane or going to meetings, but I clearly am on my feet a lot more under those circumstances than I am when I spend time at the office.   And then there are weekends and holidays, where fortunately I am reasonably active and on my feet most of the time (except for those wonderful opportunities to take a nap on a Saturday and/or Sunday afternoon).

Now, to be honest, there is a big "hook" in my assessment of this research. 

The participants were asked the question about their leisure sitting time, not their time sitting at work.  I don't know that that gives me a lot of comfort, but there remains the outside possibility that I am overreacting to this thing (I have been known to do that from time to time).  But to me, sitting is sitting, no matter where or when you do it.  I can't imagine that sitting between 8 AM and 7PM is much different than sitting between 7PM and midnight.  And anyone who spends on average more than 6 hours a day of their leisure time sitting clearly has too much leisure time and needs to get a life.

My friends who wrote this study also pointed out that the more you sit and watch TV the chances are you will eat more and gain weight.  They go on to report that we are watching more TV than we were in the past.  They also note that the workplace is changing, and there are more people like me sitting at their desks than engaged in heavy physical labor, as was the case in the past.  And while we are less physically active at work, we haven't picked up the slack by exercising more in our leisure time.   (Yes, there is legitimate scientific research that backs up every one of those observations.)

Their solution to this weighty problem?

"Public health messages and guidelines should be refined to include reducing time sitting in addition to promoting physical activity.  Because a sizeable fraction of the population spends much of their time sitting, it is beneficial to encourage sedentary individuals to stand up and walk around as well as to reach optimal levels of physical activity."

I could have said it a bit more simply: "Time to get off your butt if you want to save your life."  But that would not have been quite as scientific.

The news this afternoon that an FDA advisory panel recommended removing approval for bevacizumab (Avastin®) as a treatment for advanced breast cancer is certainly going to be difficult for patients, their families, supporters and doctors alike.

The unfortunate reality is that despite earlier reports that this targeted therapy (which has been successful in treating a number of other cancers and works by inhibiting the growth of new blood vessels that feed cancer tumors) was successful in treating advanced breast cancer didn't hold up when studied in further clinical trials.

Bevacizumab in the treatment of breast cancer has followed a long, somewhat tortuous course beginning as early as 2005 with an announcement by the National Cancer Institute that the drug was successful in a clinical trial where women with advanced breast cancer were treated with the drug.

Following that announcement, it took an additional almost 3 years until the FDA approved bevacizumab as a treatment for breast cancer.  However, that approval was not a "slam dunk", after another FDA advisory panel had recommended against approval on a close vote.  The FDA overrode the panel's recommendation, and gave the drug a conditional approval while further clinical trials were underway.

It was the results of those clinical trials that were presented to the FDA's cancer drug advisory panel today, resulting in an overwhelming (12-1) vote to remove approval of bevacizumab as an effective treatment for advanced breast cancer.

The trials in question used standard chemotherapy with or without bevacizumab, and looked to see how long the treatment(s) delayed the progression of breast cancer (what we call "progression free survival", or PFS) as well as how long the women lived after they received their treatment ("overall survival" or OS).

The reports from a couple of years ago showed the addition of bevacizumab almost doubled progression free survival from 5.8 months to 11.3 months.  However, the data at that time did not show that bevacizumab increased survival, which up to this point in time has been the "gold standard" for approving almost all cancer treatment drugs.  That is one of the reasons the FDA asked for more information.

For some of us, the core question at that time was whether or not women had a better quality of life during that period of extended progression free survival, even if the drug did not increase the length of their days.  The thinking was that even if total survival wasn't improved, at least if they had better function and less pain, it would still be worthy to consider the drug effective.  Unfortunately, the studies were not designed to give an answer to that question.

Now come the two new studies, and the news wasn't particularly impressive that bevacizumab made a real difference in the treatment of the women in the trials.

According to an FDA report, although the drug was effective in increasing the progression free survival, the duration of that effect was around 0.82 to 0.88 months in one study and 1.2 months in the other. When looking at survival, there was no real difference in women who received bevacizumab compared to those who did not.  In fact, if anything, the data suggested (but did not prove) that women who did not get bevacizumab lived longer than those who did.

The safety review of the drug also showed many more severe adverse side effects when bevacizumab was added to the treatment regimens. 

So where does this leave us?

Although there were suggestions that bevacizumab had some effect in increasing response rates in breast cancer treatment, that did not translate into particularly long increases in how long it took breast cancer to progress.  It clearly did not increase the survival for these women.  In fact, the overall survival appeared to be shorter in women who took the drug.  The reasons for that are not clear, and the possibility remains that some known or unknown side effect of the drug could have contributed to this outcome.

The panel was overwhelming in its decision, but that does not mean the FDA will withdraw the drug for this particular treatment indication.  The panel voted previously in December of 2007 not to approve the drug, but the vote then was much closer (5-4) and the FDA eventually overrode that recommendation and provided the conditional approval.  So one should not draw conclusions based on today's reports alone as to what the FDA will do in this particular situation.

There are clearly women out there who have had significant responses to bevacizumab when used either alone (during clinical trials) or with other chemotherapy.  And for them and their families today's reports are going to be difficult to accept.  But the information is what it is, and given the FDA's published concerns about the earlier clinical trials, it may be that today's evidence is a bit more solid than that presented previously.

There are several real issues that patients and their physicians will have to address immediately, such as what do you do if you are currently receiving bevacizumab as part of a treatment program?  And, especially, what if you are a woman with advanced breast cancer and have had a response to your chemotherapy regimen which contains bevacizumab? 

For women currently on the drug, it is vital that you have an open and honest conversation with your oncologist who knows you best.  The FDA has not withdrawn approval of the drug, and no one should take any drastic action (such as insurance companies stopping payment for this treatment) based on today's committee vote. 

For women with advanced breast and their doctors who may be contemplating treatment options, situation has become a bit more complex, and there is no easy answer.  I suspect there will be a lot of experts who will be offering their thoughts in various media and other reports from respected medical organizations which might give some guidance to oncologists as to what their next steps should be.

And-and this is a very important "and"-this recommendation does not apply to other cancers such as colon cancer and lung cancer where bevacizumab has shown to be effective.  Nothing about today's recommendation has anything to do with the approved use of bevacizumab in the treatment of other cancers.

Ultimately, this committee vote reflects some of the difficulties we have in determining which drugs are truly effective in treatment which cancers.  With all of the new targeted therapies on the horizon, the situation is becoming even more complicated.  Think back to Iressa®-another targeted therapy that was conditionally approved for lung cancer and then withdrawn-and the recent events surrounding the approval of Provenge® for advanced prostate cancer, and you have a sense of what I mean.

In the meantime, it is critical that we make our best efforts to design clinical trials in such a way that interpretation of the results leaves little to chance.  We can't go through too many of these events before we begin to question why we got into this situation in the first place.  When it comes to bevacizumab and breast cancer, we have had reports of success, followed by tempering of those reports, followed by a limited success resulting in a conditional approval, to today's decision to recommend withdrawing approval for treatment in advanced breast cancer be removed.

During the swing and sway of all of these decisions and recommendations over the past 5 years there have been patients, families and their doctors looking for some hope that a new drug was effective in treating a deadly disease.  Too much back and forth that never should have happened.  Too many lives have been caught in the crossfire of indecision that has enveloped this drug in the treatment of this disease.

I suspect the FDA won't take a long time to make its final decision, but no one knows for sure.  In the meantime too many women and their families are left hanging, wondering whether the cost in human and financial terms is worth it for a drug that may or may not work.

We need to do better.

How do you know if you or a loved one are getting quality cancer care? 

That's an interesting question, although it isn't a new one.  I have been asked that question on a number of occasions and in several media interviews, and quite frankly it's difficult to answer.  In no small part because like many other things we do in medicine, true quality is difficult to measure with any certainty.

I was reminded of this dilemma last week in a posting by Gary Schwitzer (someone who is highly regarded in the medical media field) on his "Health News Review" blog .  He related the story originally published in the St. Paul Pioneer Press of a woman with leukemia who wanted to get her care at one university hospital, but was told by her insurer that she had to go to another highly regarded hospital because the outcomes were better at the other institution.  This was despite the fact that-according to the information provided in the blog-she had received all of her care to that point at university hospital #1.

The story went on to relate how the insurance company said they had the data to show that outcomes for her treatment were better at hospital B compared to hospital A.  The assumption-and this is the key part of the discussion-was that the insurance company data was accurate and told the story truthfully.  The blog went on to make the point that usually when a doctor or a hospital is subject to some outside measure of "quality" that the doctor or hospital who has the "inferior" measures of quality always blames the measuring system for failing to demonstrate their (the inferior doctor/hospital's) more difficult or complex patients, or taking into consideration other circumstances that may explain the discrepancy.

To a degree, that is a point appropriately taken.  For years, as quality reports have been provided by various programs including insurance companies and Medicare, for example, the argument has always been made that "my/our patients are sicker and more complicated than their patients."  Supposedly the results are corrected for this, but there remains considerable discussion within the medical and health outcomes research communities whether or not in fact all of the variables measured can be put into a simple formula that truly reflects quality differences between doctors and hospitals.

But the major question that has to be addressed is when an insurance company says "we have the data" that in fact they do "have the data"-beyond what it costs to treat a patient at a particular hospital or by a particular doctor.   That's at the heart of the issue, since many hospitals and doctors believe that what the insurers are measuring is in fact the cost of care (dressed up as "resource utilization") as opposed to true outcomes, such as how many patients go into remission and perhaps are cured of their diseases, as would the case in the treatment of a patient with leukemia.

Getting our arms around true measures of quality has proven to be very, very difficult.  It could be that we should be looking at how well doctors and hospitals adhere to some set of standard guidelines in their processes of providing care.  Perhaps we should be looking at remissions and/or survival, adjusted for disease stage and severity.  But gathering these types of data points is very difficult and beyond the capabilities of most of the systems currently in place.  Not to mention that any one oncologist or hospital-with some exceptions-probably doesn't take care of a sufficient number of patients to provide a statistically valid sample for the quality treatment of any particular type of cancer.

What about survival statistics?  Wouldn't that be the best measure of quality cancer care?

That would seem logical, but in fact it is much more complicated than it appears at first glance.  There are questions of what we call "case mix," such as the specific diagnosis of the patient, the stage of their disease, where they live, whether or not they have insurance and what kind of insurance, and so on.  There is the reality that many doctors and hospitals may be involved in the care of one particular patient, so their outcome may not reflect the decisions and recommendations of a specific oncologist.  And then there is the question of tracking particular patients and linking them to specific physicians over years of time, in some cases decades.

We are left with the proverbial "head scratcher" question on this one.  That doesn't mean there aren't many excellent researchers, committed doctors and dedicated organizations that are trying to work through these issues.  It is just that accurately measuring the quality of cancer care is much more complicated than it seems at first glance.  The National Quality Forum, the American Society of Clinical Oncology's QOPI® program (which is a voluntary program that measures the quality of care in oncologists' offices) and the widely accepted guidelines of the National Comprehensive Cancer Network (NCCN) are but three examples of organizations trying to address the quality of care for cancer patients

For better or worse, too frequently insurance companies want to give the impression that quality is associated with lower costs.  Sometimes that may be the case, but not always.  And more and more often I suspect we are going to see networks of care restricted on cost alone under the guise of "quality care", rather than making the best decision for the treatment of a particular patient based on their specific needs.

What we are probably going to be offered in the future is a method that at some level is looks at the processes of care offered by a particular doctor or hospital.  That is pretty straightforward in some circumstances-such as at the very beginning of diagnosis and treatment of a particular cancer patient by answering the question "Are the right tests done and is the right treatment given at the right dose given for this particular patient with this particular cancer?"-but gets more complicated as the disease and its treatment continue down their respective paths.

So that leaves me with emphasizing that just because someone says one place is better than another, or one doctor is better than another it is important to keep in mind what information stands behind those statements, and how much transparency there is in the methods and the meaning of what they say. If "quality" it is based on lower costs alone, then that frequently is a non-starter since spending more or less money is not necessarily associated with "quality outcomes." 

Ultimately-in my personal opinion--it is spending money appropriately and wisely that is the key to success in cancer treatment.  How we measure that accurately and consistently continues to be a significant problem.  The good news-as mentioned above-is many of us are aware of that and are trying to do something about it. 

We can't let perfection be the enemy of the good, but as I have maintained for years, it would be terrific if the medical profession stood up and took charge of this issue, offered transparency into what they do and how they do it, and accept that we have a responsibility to our patients to hold ourselves accountable in some reasonable way to offer the assurances the care we provide our patients meets some fundamental measure of quality care.  I believe our patients are entitled to no less.  We need to measure and demonstrate our commitment to our mission and our patients' expectations.  Just saying we give quality medical care does not make it so.

In the meantime, we will have to settle for whatever quality measures someone offers-even if they aren't necessarily the quality measures that really define the quality of care we offer or receive.  A little transparency into the process would go a long way in providing insight into the accuracy of the data and the assumptions that are made based on that data. 

Just saying you measure quality cancer care does not necessarily make it so.