It's Groundhog Day, and that means millions of people will focus their attention on a furry little creature in Punxsutawney PA to see whether or not the animal sees its shadow. Breaking news bulletins say that he did, so we have six more weeks of winter to look forward to.

I--on the other hand--think there is a greater significance to Groundhog Day. It is the day when I check on my own shadow, and determine whether or not I have kept my commitment to keeping my weight steady during the past year, which has proven to be a difficult accomplishment. The answer this year is mostly yes, partly no.

A brief history:

A couple of years ago I took a look at my weight charts for the past decade (yes, Virginia, there are some of us who do that). What I saw disturbed me: for the three previous years, my weight would go down in January and February when I would rigorously diet, only to rise over the remaining months of the year. And, on top of that, when I looked back I saw that both the peaks and valleys were becoming higher and higher, so that each year my weight at the bottom of the trough was higher, and so was the peak in December. And that, my friends, would not suggest a healthy outcome.

So I dubbed this observation my "Groundhog Day Diet," based on the Bill Murray film of the same name. You may remember the picture: Murray relives Groundhog Day every day until he gets it right. Much like Mr. Murray, I decided that I would get it right by not going through the same cycle year after year.

Finally, this year I met with some success: I did gain some weight, but the peak was lower. And the numbers on the scale were steadier over the course of the year. I partly accomplished my goal. Where I missed was that I still weigh too much, just like lots of you. And, as any good doctor would tell you, over time weight takes its toll on things like our joints, our blood pressure, our cholesterol, you name it.

And here is another thought about Groundhog Day: every January many of us make a commitment to lose weight, be healthier, exercise more, etc. etc. Why not reinforce that commitment on Groundhog Day? Maybe next year you won't relive the same life. Maybe you can promise again that you are going to stick with your resolution to take better care of yourself.

Why should I do this, you might ask? And I reply why not?

Overweight and obesity is ravaging this country. A report in the Journal of the American Medical Association released yesterday tells us that over 1 in 3 adult men and women in this country are obese. Not just overweight, but obese. The toll that takes on us as people is enormous. Our health and our futures are at stake, and we all need to take a hard look at what is happening, and determine how each of us is going to address the problem. If we don't, we stand to move backwards in terms of our health, the quality of our lives and the very length of our years.

I will share with you that back in December I started to experience the effects of my weight, when my knees started to develop increasing pain. I had put on some December pounds (who doesn't?), my diet was out of control, and my exercise program became less of a priority. Six weeks later-and still working on getting back on track by being careful in what and how much I eat and exercising daily--the symptoms have abated somewhat. For me, weight gain made a very real and immediate difference in how I felt and how I could function. Losing some unnecessary pounds has made a meaningful difference in how I feel and how I function. (There are probably other contributing factors explaining my symptoms: my life is probably complicated a bit more than most because of my frequent auto and plane trips, not to mention sitting at my desk for hours on end. It certainly doesn't help.)

So what should you do?

You can commit to yourself and those you love that suffering through all the maladies associated with overweight and obesity (the polite term is "metabolic syndrome") isn't worth it, and you can do something about it. You can commit to improving your diet, increasing your exercise, and getting up out of the chair to take a walk every couple of hours around the office. Drink too much sugar in your soda or juice? Cut it down. Drink alcohol frequently? Those are empty calories also, so cut it down or cut it out. Like snacks? How about some air-popped popcorn? Maybe more fish in your diet will help. And on and on and on.

So here is to Groundhog Day, to you and to your shadow. Punxsutawney Phil only has to worry about the next six weeks of winter. You need to worry about your life. Hopefully next year your shadow will be a smaller one. And you will be much more satisfied with what you have accomplished for your health.

Quite honestly, I don't think you will miss your shadow all that much.

Sometimes science is not as convenient as we would like it to be. We want answers, we want clarity, we want direction--especially when it comes to the treatment of patients with cancer.

So when I read two articles and an editorial released Wednesday in the New England Journal of Medicine, I was struck as to how studies seeking to answer similar questions could come to different conclusions. And, as I struggled to explain the research findings to reporters prior to their release to the general public, I found myself searching for words that would adequately explain the message of the research. Quite frankly, determining that message proved to be difficult.

The studies were done by well-recognized and accomplished researchers, one group from Germany and one from a group based in the United States. The goals of the studies were to demonstrate whether or not the addition of Avastin® (bevacizumab) to chemotherapy treatment given before a woman with breast cancer had surgery improved the rate of complete response of the cancer at the time of surgery (meaning that when the surgeon did the surgery and the pathologist reviewed the specimens there was no evidence of cancer in the breast). Both studies rely on the premise that achieving a complete response in this fashion improves the outlook for women with breast cancer. In addition, the American study sought to answer the question as to which of several chemotherapy regimens were better than the others.

In the German study, women with HER-2 negative breast cancer received this treatment program (called neoadjuvant chemotherapy, meaning before surgery) using a combination of drugs including epirubicin and cyclophosphamide, followed by docetaxel. Half the women were also treated with Avastin®, and half were not.  The women who received the additional Avastin® did have a higher rate of complete response in the breast as determined at the time of surgery, particularly in women with so called "triple negative" breast cancers (which means that they were not only HER-2 negative, but also didn't have evidence of hormone receptors in their cancers). These cancers are considered to have a poorer outlook. Women who did have hormone sensitive cancers did not do better with the addition of Avastin®, and their rate of response to the treatment was less than the triple negative group. As might be expected, the addition of Avastin® increased the number of toxic side effects of the treatment.

In the American study, women were randomly assigned to one of three treatment groups, one receiving only docetaxel, another receiving docetaxel plus gemcitabine and a third group receiving the docetaxel with capecitabine. All women received additional treatment with doxorubicin and cyclophosphamide. Within each of the three treatment groups, half the women also received Avastin® and half did not.

The addition of gemcitabine or capecitabine did not improve the complete response rate of the tumors when evaluated at the time of surgery, so there was clearly no benefit to adding either drug to docetaxel. However, in the women who also received Avastin®, there was a higher complete response rate (34.5%) compared to no Avastin® (28.2 %). However, unlike the German study where women who had hormone negative tumors did better, in the US study those with hormone sensitive tumors had a more pronounce benefit from the addition of Avastin®. And, when the three "basic" chemotherapy groups were evaluated, the addition of Avastin® to the docetaxel/capecitabine arm was beneficial, but there was no effect on docetaxel alone group or the docetaxel/gemcitabine group. Once again, as in the German study, the side effects were more pronounced with the addition of Avastin®.

If all of this discussion leaves you scratching your head (assuming you have waded through the dense and very condensed descriptions of the trial above) you are not alone.

In the editorial that accompanied the research articles, the authors write:

"Subgroup analysis in the (US) and (German) trials revealed contradictory results. In the (German) trial, the rates of pathological complete response were significantly increased with bevacizumab therapy in patients with hormone-receptor-negative ("triple negative") breast cancer, whereas in the (US) trial, there was only a trend favoring bevacizumab in that population. In contrast, the (US) trial showed a significant increase in the rate of pathological complete response in patients with hormone-receptor-positive cancer, whereas in the (German) trial, no differences were noted in that population."

The writers go on to explain why those differences may have been observed, and how further studies and research may help us understand the differing results. They conclude:

"However, in the context of unsustainable expenditures for cancer care in the United States, any survival benefit of bevacizumab, or other molecularly targeted drugs, will be balanced against the considerable development costs of modern molecularly targeted oncology drugs."

So where does that leave us, when we try to explain to patients how this research might impact their lives?

First, I think it is fair to say that based on these results there is not going to be a rush to change current practice by most oncologists. There is no clear direction here, the side effects are greater, the cost not inconsiderable, and the results are in conflict. This is clearly a situation where--as noted in the editorial--we need to see further results over time, and additional research to help us understand which patients are in fact most likely to benefit from the addition of Avastin® to breast cancer treatment for women before surgery.

But to me there is a larger lesson, namely that as I mentioned earlier science and research are not always convenient. Sometimes research gives conflicting results, and sometimes the direction we need to take is not clear once the results are available. We sometimes find that research raises as many--if not more--questions than it answers. And sometimes that research cannot be easily translated into convenient sound bites (or as I like to say these days, Twitter bites since so much of our information is conveyed in messages of 140 characters or less).

It is in circumstances such as these that the thoughts of experts are important in putting research into perspective. And, for patients with cancer facing decisions about what treatment they should undertake, this type of situation underscores how important their care can be in the hands of a knowledgeable oncologist, especially one who carefully reads and understands the literature, is able to discuss the information intelligently with their patients, and is willing to spend the time to do so. It still comes down to the relationship between you and your doctor to understand what all of this means, and what is best for you. And I don't expect that truism to change any time soon, no matter how sophisticated our research may be now or in the foreseeable future.

Welcome to the New Year!

And as has been the case for many years in the past, the American Cancer Society takes the New Year opportunity of providing the nation with the latest estimates of cancer incidence and deaths, along with a measure of how well we are doing in reducing the burden of cancer in the United States.

The data is contained in two reports released today by the Society: the consumer oriented Cancer Facts and Figures 2012 and the more scientifically directed Cancer Statistics 2012. Both are available online. 

It is never "good news" to realize that the burden of cancer in this country is immense. And with the country gaining in population and age, the extent of that burden is inevitably going to increase. But this year's report does contain some welcome information, namely that cancer death rates have declined in men and women of every racial/ethnic group over the past 10 years, with the sole (and unfortunate) exception of American Indians/Alaska Natives. In addition, the Society now estimates that a bit more than one million cancer deaths (1,024,400 to be exact) have been avoided since 1991-1992.

That one million number is actually more significant than it seems. Many of the people in that 1 million never heard the words "you have cancer." Maybe they had a colon polyp removed before it became cancerous, maybe they stopped-or never started-smoking. Maybe they had a pap smear that found a pre-cancerous lesion. And then there are the patients who have benefitted from the advances in cancer treatment that have occurred over the past number of decades.

But the 1 million number also means that these are people who have hopefully remained active and engaged in life, loved by their families, productive in their communities. In economic terms, the return on investment on avoiding those one million deaths may likely be incalculable. In human terms, it is an amazing accomplishment.

However, the burdens of cancer remain significant. Excluding common skin cancers and non-invasive, very early stage cancers, the American Cancer Society estimates there will be 1,638,910 new cases of invasive cancer diagnosed in the United States in 2012. The Society also estimates that 577,190 cancer deaths will occur this year.

We continue to see decreasing death rates in more common cancers, including lung, colon, breast and prostate. For men, 40% of the decline in cancer deaths is due to the decline in lung cancer. For women, 34% of the decline is due to decreases in deaths from breast cancer.

Compared to white men and women, African American men and women still suffer disproportionately from the impact of cancer. In almost all types of cancer, 5 year survival is lower for African Americans than whites with comparable stages of cancer at diagnosis. African American men have a 15% higher incidence rate of cancer compared to white men, and a 33% higher death rate. African American women actually have a 6% lower incidence rate, but a 10% higher death rate when compared to white women. However, it is important to note that despite the grim comparisons, the most rapid decline in death rates year over year have been in African American men, at 2.4% per year. (Hispanic men have also had a rapid decline in cancer death rates of 2.3% per year.)

In addition, minorities in general tend to have higher cancer death rates from cancers linked to infectious agents-such as cervical cancer (HPV), stomach cancer (bacteria called H. Pylori), and liver cancer (hepatitis B and C virus)--compared to whites.

As has been recent custom, the reports also review a particular cancer topic of interest. This year, the special section focuses on cancers where there has an increase in incidence. These cancers include cancer of the pancreas, liver, thyroid, kidney, melanoma (the most serious form of skin cancer), cancer of the oropharynx related to HPV infection, and adenocarcinoma of the esophagus (swallowing tube).

The reasons for the increases in each of these cancers-to the degree we can understand the cause of the increase--are different, and are reviewed in detail in the online reports. For example in thyroid cancer it may be that we are better able to detect smaller cancers with ultrasound and that there is increased awareness of the disease. On the other hand, according to the authors, other studies suggest that the increase is real, and due to factors other than improved diagnosis.

Obesity may also play a role in the increased incidence of some of these cancers, particularly adenocarcinoma of the esophagus and cancers of the pancreas, liver and kidney. That explains why many experts in the field are concerned that the rising rates of obesity in our country may supplant some of the gains we have made in prevention, diagnosis and treatment of cancer over the past two decades.

One particularly interesting observation is the rising incidence of oral cancers related to HPV infection, especially in white men and to a lesser degree in white women. In fact, from 1999-2008 (the last year for which reliable data is available), HPV-related oral cancers have increased 4.4% per year in white men and 1.9% per year in white women. In an interesting contrast, rates for this type of cancer have not increased in other ethnic groups. Many experts are now focused on sexual practices as the explanation for this increase, which is caused in 90% of the cases by a single subtype of the HPV virus (16). This raises the interesting question whether the relatively recently introduced HPV vaccine-which is effective in decreasing the incidence of HPV 16 infection in women if given before the onset of sexual activity-would also reduce the frequency of these oral cancers. But the jury remains "out" on that particular question.

So, as is frequently the case, Cancer Facts and Figures offers some hopeful news and some questions. We have certainly made progress, although there is much further to go. And for some cancers and for some groups among us, there remains the sad reality that there is much more we could do. Whether it is access to improved preventive, early detection and treatment options, or whether it is a better understanding of how we can effectively prevent or treat some cancers which we are seeing more frequently, it remains a fact that we cannot look back at the million deaths averted and rest on our laurels.

Yes, we have made considerable progress. But as these reports demonstrate so clearly, we still have a long way to go.

This week I decided to read a section in the newspaper I don't ordinarily have time for and came across an article that described all the wonderful technology and social media that is being applied to the science of getting people to, into, and out of the shopping mall parking lot-especially during this season of holiday joy.

There appear to be several premises driving parking lot technology. Among them: 1) get them to the parking lot. If the lot is too full, maybe having them come later might be customer-friendly. You know, build mall parking lot loyalty and all that stuff through serving the customer (remember that thought). 2) Once they get to the lot, get them to the closest parking spot which is what everyone wants. (Except me. I like to park far away and tote up the steps on my pedometer. My wife is not a fan of that strategy.) 3) Provide them valet services that work, including having the car ready and waiting for you when you set back to the front door laden with packages by using beepers that can signal the valet you are on your way.

There are other aspects of this wondrous technology, including special lights that show you where there was an available place just for you, social media apps that transmit this information to your smart phone, big signs that tell you the same thing so you don't have to be distracted from driving looking at your smart phone while you are trying to find a parking spot.

As I said, fascinating stuff. But what could this possibly have to do with health care?

Maybe we should have a contest to see who comes up with the best answer to the question about why technology and social media for the parking lot is more important than saving lives and treating people?

One cynical response would be that a big chunk of the economy is driven by the consumer, so it would be natural that we would want to make their shopping experience more pleasant with less exertion or worry. That might be a winner, until you figure out that health care isn't exactly a small chunk of the economy. And right now it's growing a lot faster than consumer spending.

Here is the bottom line: we can get you a space in a parking lot, but we can't get a system in place to avoid you having to fill out the pesky paper patient information forms every time you go to a new doctor-and even periodically when you are going to the same doctor. We can't have your medical records in a single place, such that you don't have to repeat every test every time. We can't figure out how to routinely take the sophisticated lab test or x-ray you had in one place come up in another place. Ditto on pathology slides, genetic tests, even routine blood tests.

And then there is the business side of the house.

I am becoming more and more convinced that there are literally armies of clerks sitting behind telephones prepared to confuse you and your doctor and deny you medical care for no reasonable reason (promise you, we had a situation like that in our family this past year, and my wife-an ob/gyn-faces bizarre situations like this regularly). Oh, yes, there are indications for various tests and procedures, but your doctor has to call in first. And if the clerk doesn't understand the test or procedure-or it doesn't fit a neat algorithm sitting in front of her or him-it gets bumped up another level and then another level. Eventually it may get to a doctor or nurse who may be trained to understand the particular issue, but then that doctor or nurse has to talk to your doctor or nurse who may be busy doing something else like brain surgery when the insurance doctor or nurse demands to talk to them (actually, that little scenario is based on a true story from a major cancer center. Maybe we should have all the doctors and nurses who are busy taking care of patients during the day call the insurance doctors and nurses at the same time, like 3AM in the morning.).

There is fraud and waste in medicine. We agree. But the burden of this oversight process on the typical patient and doctor's office is getting beyond ridiculous. There are not enough people in the world to make this work, and make it work economically.

Again, back to the parking lot question: You don't think if they really wanted to the insurers couldn't streamline this process electronically? You don't think they could focus on the outliers as opposed to trying to tease apart almost every single decision made between doctors and patients to determine if it is medically necessary? Do you think this has done a lot to bring down or control medical costs (has your insurance decreased recently???? Do you think we have improved the health care system while all this is going on? Are we really giving more effective and appropriate care?). Do you think it is possible-just possible-that creating a simple, information based electronic system to handle this nonsense might help streamline this system for doctors, patients and insurers? Is every doctor a thief mistreating their patients? I don't think so, but it is appearing more and more that that is the philosophy driving this system, and that is not good.

And now the reason why I am writing this blog in the first place.

There is a battle going on in Washington having to do directly with the questions I raised above. And the American Cancer Society has been quoted extensively this past week raising the flag on this particular issue.

Whether or not you are a fan of the Affordable Care Act, it is the law and barring some event over the next 12 months (or perhaps later), we are going to be subject to that law. And when you have a law, there is the need to write regulations. And those regulations for the ACA are being fought over and written write now. If we don't pay attention today, then we will find ourselves in a not-so-good place later on when the Act actually has most of its major provisions go into effect.

One of those provisions deal with medical loss ratios. Medical loss ratios in human terms means the amount of money actually spent on true patient care vs administrative expenses.

Guess what? The insurers are supposed to spend 80% of their dollars on actual medical care and 20% max on administrative expenses under the new law. So what is a medical expense and what is an administrative expense becomes a very important topic.

So a prize goes to the person who gets this question right: You are an insurer, and you have an army of people reviewing everything your doctor or other health professional does to the people you insure, every test, every x-ray, every hospital admission, every surgery, etc. etc. In short you have an army of approvers sitting at your desks doing their deeds. It's a lot of money.

Now, which bucket do you think you want those expenses to fall in? The 80% bucket that provides for medical care or the 20% bucket that pays for administrative expenses? As an insurer if they go in to the larger bucket, you win. If it goes into the 20% bucket you lose. You lose because what you have created is expensive, cumbersome, and is not focused on the places where you really have a problem. It just gums up the works, makes people angry, and doesn't do much to save lives most of the time. You may actually have to reduce some salaries and stock options if you have to squeeze the money to pay for all of this nonsense from the 20% bucket. You may actually have to deliver on the promise of developing effective, electronic simple to use medical approval processes. You may actually have to streamline an arcane, obtuse and incredibly expensive and inefficient system.

So there is this big argument going on in Washington as to where the money is going to go, and ultimately it will impact the amount of real medical care you will receive. I don't think people are of the impression that someone sitting on a phone in a distant place responding to your questions in a dull tone, or our doctors and their offices spending scads of time doing the same thing really counts as medical care. I think patients would rather have their doctors and their staff spending time taking care of them.

Which brings us back to the parking lot. If we can automate the parking lot, why can't we automate medical practice? The answer is: we can, if we wanted to. And if the insurers wanted to, they could get the job done instead of finding all sorts of excuses to plod on like Luddites in the wilderness.

Will we ever see the day of true efficiency in medical care? Maybe. And getting these gobs of administrative expenses into the right bucket-as a true administrative expense, as if there is any question-may just be the catalyst this bizarre situation requires.

It isn't much of a road, really. A single lane gravel covered path through the National Forest near our home in North Georgia. It isn't a grand road, like an interstate where cars go about their business at 70 MPH or more, or large trucks haul their goods from coast to coast. It isn't a grand boulevard, like Park Avenue in New York or Michigan Avenue in Chicago.

No, it's just a country road. But for me, it's a beautiful road. It's a place to take a long walk pretty much undisturbed, especially on a Thanksgiving Day like today. It's a road through hardwoods that have lost most of their leaves, which make a beautiful reddish brown canopy on the forest floor, awaiting the inevitable decay that comes with winter. The pine trees and the holly bushes stand their green guard, awaiting the spring when the oaks, mountain laurel and rhododendron will make their reappearance to joys of many.

This morning was an especially pretty time to take a walk along the road. It was cold (32 degrees), the sky was covered in mist, with puffs of smoke rising from the river that runs along much of my path. As the sun rose, the mist gave way to cloudless blue skies, with the sound of the overnight frost dripping water onto the leaves of the trees below. And the river made its gurgling sound, occasionally punctuated by the report of a hunter's rifle.

What is so special about this road on this particular day?

We live in difficult times. Washington is in rancor, the world is in distress, many are struggling every day to meet basic needs. We are all affected by the turmoil and distress that confronts us. But somehow, walking along this road lets me clear my mind, think more soundly, and put some of the "other stuff" aside, at least for this special Thanksgiving Day. It gives me a moment to think about how thankful I really am for what I have in my life.

Oh, for sure, as I take my walk I can't not think about what this day has in store for me, my family and our friends who will gather with us tonight for dinner. Turkey, duck, barbecue, brunswick stew, and pumpkin everything from morning pancakes to a side dish of pumpkin squash during the main meal to the pie that signals the end of the festivities.

But the country road is about a lot more than food. It is about the beauty in our lives, the friendships we enjoy, the accomplishments of our families. It is about being thankful for so many things--so many things that we frequently don't have the time to think about. The things that make our lives special, even in times of difficulty.

Think of the gold miner who sifts the dirt in the river for days on end to find that one nugget of gold. That precious piece of gold makes it all worthwhile. In a sense, many of us work through so many situations at work and at home to seek that gold, appreciate it, treasure it.

So on this special day of Thanksgiving, I hope you will find the time to enjoy our successes, our pieces of gold. For me, my family, my friends, my colleagues, the organization I work for are all moments of gold in my life. They make it all worthwhile.

But to appreciate that gold in your life, you may first need to find your country road. It doesn't have to be an actual road. It may be a special chair in a special place. It may be in a place where you can be with friends and family and find a quiet moment to reflect on how fortunate you really are. It may be in a park on a bench, or a boat on a lake. But it is somewhere in your life, and on this Thanksgiving Day, take a moment to find it, savor it, and appreciate the blessings that all of us have in our lives.

So from my road to yours, Happy Thanksgiving!

The announcement today from Canada that women should severely curtail their use of screening mammograms for the early detection of breast cancer and discontinue regular clinical examinations and self-breast examinations was interesting in and of its own. But the editorial that accompanied that announcement-from a long-time avowed skeptic of the benefits of screening mammograms-took the debate to a new level. Whether that level was higher or lower is a matter of personal interpretation, but in the editorial was the statement that abandoning breast cancer screening is the most effective way we have to reduce the risks of breast cancer. The statement, highlighted in an accompanying press release (http://www.eurekalert.org/pub_releases/2011-11/cmaj-nbc111611.php) was, in short a stunner.

What is even more amazing is that there hasn't been much reaction to that statement. And keep in mind that just two days earlier, the medical journal The Lancet published a letter from an international  group of experts in breast cancer screening who raised the issue of an organized anti-mammography campaign orchestrated in part by the head of the Nordic Cochrane Centre, headed by none other than the physician who wrote the editorial. But from where I sit-a place that is usually the epicenter of these discussions-there has in fact been very little reaction. No media, no frantic calls, no running to man the barricades. Essentially, nothing.

I find that hard to understand for a story with this degree of impact. Maybe we are all just worn out from the screening debates, after several years of indecision about the benefits of mammograms, the frequency of pap tests, and the big debate recently about whether or not prostate cancer screening really saves lives.

For me and others I know, there is increasing concern that the value of screening for the prevention and early detection of cancer will get lost in the morass of conflicting comments, and that we might be at risk of turning off the public to the benefits of screening for cancer, and perhaps lives will be lost in the process. And that would be shameful.

When I started medical school in the late 1960's, we were told by our professors about the number of cancers that were found on autopsy that were not detected during life and were "incidental" to the death of the patient. Prostate cancer was particularly common as men aged. Thyroid cancers were also common as "incidentalomas", and there were breast cancers as well as other cancers that never came to a diagnosis during a patient's life.

From a cancer point of view, we had the "early warning signs of cancer," which unfortunately were the "late signs of cancer." Blood in the stool, a cough that wouldn't go away, and a bleeding lesion on the skin were on the list.

So, it wasn't much of a leap for all of us to truly believe that if we could find a cancer before we could feel the cancer, we would be much better off.

As time went on, that is exactly what happened. Research in the 1960's showed that an x-ray of the breast could detect a cancer before we could feel it. Before that, a woman would present to the doctor after she felt a lump or perhaps the doctor would feel the lump on a physical examination. We would tell the woman we "caught the cancer early," usually after she went to surgery and woke up without her breast. More often than not, the lesion was fairly large and had spread to the lymph nodes. "We got it all" was a common refrain, but in fact we learned that frequently we did not. The cancer had spread, and disability and death was the outcome for too many women.

Fast forward to today, and where do we stand?

The mammography debates go on and on: does mammography really make a difference, or is it the improvements in breast awareness and self-detection and treatment that account for the significant reductions in deaths from breast cancer that we have seen since the early 1990's? When do you start getting a mammogram? At age 40 as the American Cancer Society recommends, or at age 50 as recommended by the USPSTF? Do you get a mammogram every year, every other year, or every 3 years?

So now back to the history lesson:

Before we had screening, we had nothing. We would sit and scratch our heads, telling ourselves that if we could find cancer before it found our patients, wouldn't that be terrific? It was axiomatic that if we found a cancer early, there was no question we would help our patients.

Well, our prayers were answered. We developed and improved screening mammography. We continue to move the threshold of detection to smaller and smaller cancers, and I have no doubt that we will continue to move that threshold even lower still.

But what we didn't consider was that in some cases treatments would improve, saving lives that could not have been saved before. We developed adjuvant treatments for breast cancer that reduced deaths from that disease, especially for women who had lymph node involvement--which we learned was in fact not a step along the way for the spread of breast cancer but in fact a signal that cancer cells had spread elsewhere in the body.

We also relearned some biologic truths: just because we found a cancer, that didn't mean that that particular cancer was destined to cause harm to a person during their lifetime. We are now able to routinely find cancers that our professors were previously only able to see on autopsy.

So where does that leave us today?

First, our science moves on. We have better detection methods, and we also have better treatment methods. We have some glimmers that we can define which cancers may be aggressive and which may be more indolent (especially for breast cancer and unfortunately not to clearly for prostate cancer). We have drugs that have dramatically reduced the risk of death from some forms of breast cancer, particularly HER-2 positive breast cancers where research shows that treated early deaths decline about 50%.

Forty-five years ago we sat around and wondered how we could find cancer early and save lives. Today we sit around and argue about whether finding cancer early makes a difference.

So who is right?The people who believe that they have never seen a screening test they didn't like? Or the people who say screening for certain cancers at best has been oversold and at worst doesn't work?

Actually there is a little truth for everyone.

We now find cancers we never dreamed of finding back in 1970. And our research suggests that not every one of those cancers is a killer. Our treatments for certain cancers--especially adjuvant therapies for breast and colorectal cancer--are saving lives. And, yes, we are overtreating people who would never have been bothered by their cancer.

The problem is we frequently can't tell what made a difference in a particular person's life once they have been diagnosed with a cancer detected through screening. We can't tell a woman with breast cancer whether or not her particular cancer is a killer or just an incidental event in her life that will have no impact if left alone.

What does the American Cancer Society believe?

We still believe that mammography saves lives, as does the United States Preventive Services Task Force, incidentally. We also believe that mammography allows treatments that are less disfiguring and equally effective to what women used to go through, which was mutilating.

However, we also believe that mammography is not the only thing that saves lives. Treatments have improved, and lives have been saved. Women are more aware, although I am not certain that that awareness leads to finding smaller cancers in the breast.

Our science has moved on, and sometimes that creates as much confusion as it does clarity.

The biggest lessons for patients is the need to understand the benefits and risks of the screening tests we are offered. We really need to become educated and to be our own advocates. We need to understand--and our health professionals need to help us understand--the nuances of the tests we are offered.

Many of us would like to live in an "all or nothing" world. Either screening works or it doesn't. Uncertainties are viewed with suspicion.

But real life is not so convenient. And it's up to us to understand that dogma doesn't get us where we need to be, especially when it comes to our health and in particular regarding the early detection and prevention of cancer.

And then we end up with the editorial published today suggesting that no screening for breast cancer is the best screening. And I say that such a position may not take us back to the 1960's, but not far from that. We will have more women having more mastectomies because the cancers are larger. And more women will have chest wall invasion, and more women will have lymph node involvement and our use of radiation and post-operative adjuvant chemotherapy will not get us back to baseline. Not to mention that the decline in breast cancer death rates in the United States that we have seen year over year since the early 1990's would likely stop at some point over the next 10 years.

I am not a Luddite. At least I hope I am not. But this is one journey I do not want to take back to the future- -for my wife, my family, my friends, my colleagues or anyone else for that matter. It is a future I and others have seen, and we don't want to or need to revisit that past. It was awful then and it would be awful now.

Right now I will admit to feeling very worn down by the constant barrage of anti-screening statements that I have seen. But saying that no screening is the answer to breast cancer is a new level I never thought we would reach. And to not see a peep of criticism raised is perhaps more disconcerting than the statement itself. Allowing such thoughts to go unchallenged is not acceptable. It demeans the other side of the argument, and suggests in fact there is no other side.

So we will continue to wander in in the morass of conflicting recommendations enhanced by illogical rhetoric. Instead of having rational discussions of the benefits and risks of cancer screening, we will have the populace turning off to breast cancer early detection entirely. And over a decade from now, in my personal opinion, we will see the impact of our choices. And I do not believe it will be a pretty picture.

The sad part is that by ignoring all of the science, we will have only ourselves to blame.

Today the Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, announced that the FDA is withdrawing approval of Avastin® (bevacizumab) for the treatment of metastatic breast cancer.

This announcement culminates a highly watched process where the FDA determined that although it had granted accelerated approval for the use of this drug in treating breast cancer, subsequent studies did not demonstrate in any group of women that Avastin® actually helped patients in any meaningful way, while causing significant harms-including death.

In the accelerated approval process, the FDA permits a company to market a drug for a specific indication, usually in a life threatening disease, while allowing the company to perform additional trials to confirm the value of the drug. After those trials are done, under this form of approval, the FDA reserves the right to revoke that approval if the original promise of the drug is not confirmed. That is what has happened with Avastin® in breast cancer.

As difficult as this decision has been for the FDA, it is even more difficult for women (and their loved ones and their doctors) who believe that Avastin® has saved their lives. The Commissioner emphasized that she was acutely aware of that concern in making her determination, but she underlined the fact that when the science was carefully reviewed, there was no evidence of meaningful benefit of Avastin® in breast cancer treatment.

The full impact of this decision is difficult to determine at this time.

First and foremost are the women who are currently receiving Avastin® as part of their treatment program. In those circumstances, they must have discussions with their treating oncologists to determine what the best course of action may be. It is important to note that-as the Commissioner stated several times in a telephone conference this morning-the FDA does not practice medicine. Doctors remain free to use Avastin® as a treatment for metastatic breast cancer, with the understanding that they have a careful and thoughtful discussion with their patients about the findings regarding the benefits of the drug, weighed against the possibility of severe side effects. The use of Avastin® in other cancers where it is approved-including lung, colon, kidney and brain cancers-is not affected by today's order.

This decision will obviously lead insurance companies to review their payment policies regarding Avastin® in breast cancer. Other experts have made their opinions known that in their experience Avastin® has proven beneficial for breast cancer patients. Whether those opinions will provide sufficient reason for insurers and government programs such as Medicare and Medicaid to pay for this treatment remains unknown at this time (A news report that appeared as I was writing this blog says that Medicare has stated it will continue coverage. I have not been able to verify that report). At the least, we would hope that insurers will continue to cover treatment with Avastin® in those women currently on the drug and who are showing a benefit from its use.

Ultimately, as noted by the Commissioner, this was a difficult decision to make, but one that had to be made based on the science. She expressed her hope that Genentech-the company that developed and distributes the drug-will continue its research studies to find out if there are particular groups of women that can be identified who will show greater benefits than have been seen to date.

This may not be the end of the long and tortured path for the story of Avastin® and breast cancer, which actually started well before the FDA initially provided approval in 2008. There were delays of several years between the first research reports that Avastin® was effective in treating advanced breast cancer and the time the FDA actually granted accelerated approval for the drug. Then there were the additional studies that had to be completed as an outgrowth of the accelerated approval process, to show whether or not the early promises of benefit were confirmed in further studies.

When the FDA announced a preliminary determination that they had reviewed the results of those additional studies and concluded that their prior approval should be withdrawn, Genentech requested a formal hearing from the FDA. That hearing was held in June, where women and their physicians made it painfully clear that they thought Avastin® worked, and in some cases had saved their lives. On the other side of the discussion were the scientists from the FDA who were steadfast in their analysis and opinions that Avastin® not only did not save lives, it actually may have caused more serious harms (including deaths) than justified by the potential but difficult to demonstrate benefit of the drug. A group of cancer experts who voted at the end of the presentations sided unanimously with the FDA.

Now we have the final determination from the FDA Commissioner. But that may not be the end of the story.  The Commissioner indicated this morning that although regulatory review of this issue has been completed, there remains the possibility this could be taken to the courts for further adjudication.

As we move forward in the era of targeted therapies, there are bound to be more situations where the initial optimistic expectations of scientists, doctors and patients may not be borne out with further investigation.

We can all hope for success, but when success is not confirmed by the science we must be willing to reconsider whether our hopes were in fact realities. That is neither simple nor easy, especially when dealing with human life. But it is a principle to which we must adhere if we are to be honest with ourselves, our patients and those we serve.

It's that time of year again.

Thanksgiving is just a week away (go turkey!!!), which means today is the American Cancer Society's annual Great American Smokeout (or GASO for short). In fact, 2011 is the 36th year for the Smokeout, which makes it a longstanding (and successful) tradition in our world.

What, you may ask, is GASO?

Well, GASO is a day to focus on the opportunity--if you are a smoker or know someone who is--to make a commitment to quit, or perhaps a day to choose as your "quit day" if you were alert enough to plan ahead. It is a day when you can take a step that could be one of the most important ones you can make, a pledge to do something which could be the single greatest thing you can do for your health, a day to reduce your risk of death from cancer and many other diseases related to smoking.

Quitting isn't easy. We all know that. Cigarettes and other forms of tobacco are among the most addicting substances we can take into our bodies. And the sad reality is that if you decide to smoke, the chances are about 1 in 2 that smoking will have a role in causing your death. And to make matters even worse, that death is likely to be premature.

In fact, every year in this country, 443,000 people die from tobacco related illnesses.

If that number doesn't scare you, think about it this way (maybe because I am on an airplane as a write this):

If we lost three 747 airliners (which can carry over 400 passengers) every day for a year, we would be in an uproar. But we allow that same thing to happen every day without getting all that upset about it. And, by the way, 49,400 of those 443,000 people are non-smokers.

In addition, 30% of cancer deaths in the United States are related to smoking--as are 87% of lung cancer deaths. And it's not just lung cancer: it is 14 other cancers as well, such as bladder cancer, head and neck cancer, cervical cancer, pancreatic cancer, and colon cancer among others. We know that if you quit tobacco your risk of lung cancer will go down. In fact, in 10 years, your risk will be half what it would have been had you continued to smoke. And, if you stop smoking, you will on average live 10 years longer than someone who didn't quit.

We have made progress in this country against tobacco. We have many fewer smokers now than we did decades ago, but we have stalled at the number of smokers with about 20 -21% of the population still smoking. And kids continue to pick up the habit despite our best efforts. We have smoke free laws throughout the United States, and have been successful in many states at increasing the cost of a pack of cigarettes enough to make some people think twice about starting smoking and others thinking seriously about quitting.

We have medications to help people quit, and counseling services that have been shown to increase the odds you will be successful in your efforts. And there are prescription medicines available that will help you quit if you haven't been successful with over-the-counter products that are readily available everywhere.

Despite all of this, we still have people who smoke. Maybe that person is you or someone you love.

So what's holding you back? We know that many smokers want to quit, and that many smokers have tried to quit many times. But we also know that failing to maintain a smoke-free life does not mean failure. It may well be the next "quit effort" that could be the charm.

The American Cancer Society wants to help you make good on your pledge. Check out  the information on our website at www.cancer.org/smokeout  or give us a call at 1-800-227-2345. We are here to help whenever you need us.

And, if you make the pledge today, perhaps  on next year's 37th Great American Smokeout you will be able to celebrate your one year anniversary of being free from the shackles of tobacco.  And that would make next Thanksgiving a great occasion.

So, why not go for it? Make the promise today for you and those who love you. Nothing could make your family more thankful next Thanksgiving than knowing you cared enough about yourself to do something as important for your health than getting off tobacco.

Even the turkey and stuffing would be glad to be a second act to that celebration.

As you know, my posts to the blog have been missing in action for the past several weeks. Nothing bad or wrong, mind you. Just lots of travel, lots of meetings, lectures and getting to know some very wonderful people across the country.

So I am sitting here on a Sunday afternoon, trying to catch up on emails while attending yet another meeting (yes, on a Sunday. Maybe it's time to get a life). And I came across the message below about our Hope Lodge in Manhattan which celebrated its fourth anniversary this past week. And when you think about it, it is a very special story:

"This past Saturday, November 5, Hope Lodge NYC celebrated its 4th birthday! We are proud to report that, since opening our doors, we have served 6,900 cancer outpatients and their caregivers (55% patients; 45% caregivers)...Here are some highlights (cumulative figures):

* Representation from 29 countries and 46 states

* Average length of stay: 3 weeks

* 60% Female; 40% Male

* 26 referring institutions

* Daily wait list

* 63,000 nights of lodging provided

* Savings to patients in hotel costs of nearly $20 million!

* 580 wellness and educational programs conducted

* 475 social activities held thousands of hospitality, wellness and employee/community group volunteers

"We are grateful to all those who work with us to make introductions to Hope Lodge NYC, continue to help us complete our capital campaign (still a ways to go), raise funds to support our annual budget, volunteer time and talent, and create awareness about our home-away-from home for cancer patients and their caregivers. We are truly giving individuals a chance to survive...another birthday....and we all join together in taking great pride in this "gem" in the heart of Manhattan.

"Mamie, a patient from Georgia, left behind these thoughts: 'Arriving here at Hope Lodge was truly an incredible experience, beyond anything I could have imagined. I had a long, hard journey....cancer treatments, congestive heart failure and other complications. I am so happy to say that I have completed my treatments and I am cancer free! Hope Lodge helped me to be optimistic and to realize that cancer does not mean that you have to be alone. There are so many people willing to lend a helping hand. Hope Lodge brought me peace during a very difficult time in my life. I thank the American Cancer Society, the staff, volunteers and donors who make it possible. You helped me more than words can express....' "

There are a number of programs that the American Cancer Society offers to help people with cancer get well and celebrate more birthdays. Yet I suspect that many of you don't know about many of those activities--until you or someone you know or love is diagnosed and treated for cancer. It may be a call to our information center, a visit to our website, or help getting back and forth from your cancer treatment.

Hope Lodge is one of those very special programs. Our Lodge in Manhattan is just one of 31 Lodges around the country, frequently associated with major cancer centers or in cities where several cancer centers are located. These lodges provide housing at no cost to patients and their caregivers as they receive their treatment, which is frequently highly specialized cancer care at locations far from their homes as was the case with Mamie whose comments are offered above.

At a time of great need, patients are able to receive care that they may not have otherwise been able to consider because the costs of housing would have made such care far beyond their means. And the ability of the Society to provide that incredible service is a direct result of the efforts of people just like you, people who care and make it possible for the American Cancer Society to do what we do.

So I add my congratulations to the Hope Lodge in Manhattan as they celebrate their anniversary, and to the many Hope Lodges, their dedicated staffs and volunteers around the country who make this wonderful program available to so many.

But most of all I thank those of you who do so much all year long to help us fund these programs and make them possible. Hope Lodge is but one program of the Society which for eases the burdens of people from across the country at a moment in their lives when their needs are the greatest.

You are truly their angels for making these services possible. Many people are going to celebrate more birthdays because of you. So, thank you for all that you do!

To screen or not to screen for prostate cancer, that is the question. Or is it?

A report from the venerable United States Preventive Services Task Force (USPSTF) made it to the media yesterday--a bit ahead of schedule--and it not only says we aren't certain whether a man should get a PSA test to find prostate cancer early, it came flat out and said, effectively, "Don't do it!"

Now that is a recommendation that is going to create a good deal of discussion, I would think.

Whether PSA testing to find prostate cancer early really saves lives is not certain. The test has been around for over two decades, but it wasn't until recently that there were any scientific studies that could provide evidence whether or not the test actually worked. And those two studies produced conflicting results, or so it seemed.

One study done in several European countries found that PSA screening reduced deaths from prostate cancer by about 20%. Another study done in the United States concluded that PSA screening did no such thing. In fact, in the US study, the deaths from prostate cancer were greater during the period of the study in men who were screened vs. those who were not, but that difference was not found to be statistically significant.

Basically, what has happened is that the Task Force reviewed all of the evidence as to whether or not PSA screening decreased death rates from prostate cancer, and whether or not the harms from early diagnosis and treatment outweighed the benefits.

In reviewing the available studies, they found studies that tried to answer the question, but didn't find any that were really well done. So they had to rely on a lesser level of evidence, and among that evidence were the two studies noted above.

In the European study, they pointed out that for ALL of the men included in the study, ages 50-74, there was no reduction in deaths in the group with PSA testing. They also pointed out that the European study was in fact a "compilation" of trials in several centers in several countries, and that the frequency of PSA testing differed considerably from center to center (every 2-7 years, not every year as is commonly done in the United States).

The USPSTF researchers also pointed out that the group where the reduced death rates were found was in fact a "select" group of men ages 55-69. Furthermore, not all men in that study were treated equally: men who were in the "PSA testing arm" were treated in academic centers, where they would have arguably received better care, compared to the untested control group who were treated in community hospitals.

Another wrinkle was highlighted by the researchers who pointed out that one of the Swedish centers that participated in the trial had exceptionally good results (in fact the only center in the study that had such great results). Take that center out of the analysis, and voila! the benefits of screening in the European study miraculously vanishes.

Then there was the United States study, were many of the men in the "untested" control arm had PSA tests anyway, thus making the results of "no benefit" less than clear cut.

I could go on, but I think you can begin to understand the dilemmas all of us have faced in trying to figure out whether or not PSA testing really works. And let's not ignore the question of what happens to men after they receive treatment for their prostate cancer, problems that are not insignificant such as incontinence of urine, difficulty with bowel movements, impotence and more. These are not minor issues.

So here is a test that has strong advocates, not the least of whom are the truly well-meaning men and their loved ones, friends and colleagues who truly believe that PSA testing saved their lives. And not a few of those men are in positions of influence, including a number of Congressmen and Senators, senior executives, celebrities, you name it. They were told that PSA testing saved their lives and I would expect they would take that advice to heart. Hear it often enough, and you believe it.

But just saying something often enough, loud enough and clear enough does not make it so. Just ask the women who took all those hormones for all those years, and all those doctors who thought they were doing the right thing for their patients by prescribing those medications. They too thought hormones were good for their health, until the evidence proved it wasn't so. (Hormone therapy remains a useful treatment, but only with a clear understanding of the risks and benefits of those treatments.)

So, now we find ourselves on the horns of a dilemma. The Task Force is on record as recommending that men NOT get PSA testing. They conclude there is no real proof of benefit, and real proof of harms. Too many men go through too many treatments with too many long -lasting complications without a clear expectation that it will save their lives.

That's pretty radical, and is certain to raise a firestorm of criticism among those who believe that PSA testing saves lives.

The American Cancer Society went through the same evidence a couple of years ago and had the same discussions. We elected to say to men that we did not know whether or not PSA testing saved lives, but thought the best approach was for men and their health professionals to have a clear discussion, outlining the benefits and risks before embarking on a program of PSA testing. And that remains our recommendation today.

But I will say that even then, the evidence of benefit from PSA screening was certainly not overwhelming, if it existed at all. We knew then about the issues with the United States trial; there were whispers about some problems with the European study that are now more clearly discussed in the Task Force report. But the bottom line remains for both organizations that the evidence is not firm that the test makes a real difference.

After all this, you know what really gets me upset?

We have invested over 20 years of belief that PSA testing works. Catch it early, treat it early, and get it out. Save a life. That's the mantra many of us--including me, as a practicing physician--believed. And here we are all of these years later, and we don't know for sure. That is not an acceptable situation. Plain and simple, we have not done our homework to prove our point. And the chickens are coming home to roost.

Unfortunately, those "chickens" are men like me who dutifully get our blood tested every year. We have been poked and probed, we have been operated on by doctors and robots, we have been radiated with fancy machines, we have spent literally billions of dollars. And what do we have? A mess of false hope?

Back in the early part of this decade, researchers came to the conclusion that although there were some benefits to hormone therapies for post-menopausal women, there were more harms that outweighed their routine use. Almost a decade later, there has been a significant decline in hormone usage, we are more aware of the risks, we counsel our patients carefully about the use of these medicines, and we recommend the lowest dose for the shortest period of time.

Now we are about to face similar issues with prostate cancer screening. We will argue, we will refute the other persons science, yet I suspect we will come to an understanding that just because experts, doctors and grateful patients and their families say it often enough and loud enough does not make it so.

As someone reminded me recently, anecdote is not a form of evidence. And for PSA screening, unfortunately, according to the Preventive Services Task Force, the evidence just isn't there.

It's always hard to learn that the emperor in fact has no clothes. The sad reality, however, is that this debate is not about a fairly tale. It's real life, my friends. And people have been hurt, and doctors have been deceived. At least, that's what the Task Force is saying.

Maybe it's time to listen to evidence instead of hope. Sometimes that's hard to do.