I am going to be on vacation from this afternoon through next Friday, so I won't be posting anything until at least then.

When I return, I will be attending the annual meeting of the American Society of Clinical Oncology.  Hopefully, there will be much to report from those sessions.

Have a safe and pleasant Memorial Day holiday!!!

A couple of months ago I mentioned that I attended a conference in Toronto where we discussed the topics of ultraviolet radiation, vitamin D and health.

Today, the Canadian Cancer Society released the first public information from the conference, which was cosponsored by the American Cancer Society, the World Health Organization and other organizations from Canada, the United States and Australia.

Although we did our best to craft concise messages to help explain what we know and what we don’t know about vitamin D and your health, there is concern that those messages will not be understood by many folks. 

And, worse, there is the risk the messages may be deliberately misinterpreted to promote behaviors that are associated with significant increased risks to one’s health, particularly with respect to skin damage.

For an actual copy of the statement, please go to the posting on the Canadian Cancer Society website.

There is no dispute among medical professionals that vitamin D is beneficial for our health, and there is no dispute that sun exposure is the major source of vitamin D for most of us.

But there is also no dispute that exposure to ultraviolet rays type A and B (UVA and UVB) from the sun and other commercial sources can be harmful.  Skin cancers, melanoma and cataracts are all increased by UV exposure. 

In this country, over 1 million cases of non-melanoma skin cancer will be diagnosed in 2006.  Although many people think that skin cancers are simple and relatively “benign,” (have you heard the phrase, “If you are going to get a cancer, skin cancer is the one to get?”), the reality is that the treatment for some of these skin cancers can be disfiguring and devastating.

There will be about 62,000 folks diagnosed with melanoma, and 7910 people will die from this disease.  There will be close to 50,000 people diagnosed with melanoma in-situ, which means it is very early and doesn’t invade deeply into the skin.

And if you are young and still feel immortal, you need to be aware that the incidence of melanoma among young folks, although still rare, is increasing.  And, if that doesn’t scare you, take a look at your close relatives who have had a lot of sun exposure and admire their wrinkles.  They are in no small part due to the aging effects of the sun on the skin.

I think it is fair to say that there are many experts who are very concerned about the risks of sun exposure.

But does that mean that we should avoid the sun completely?  Should we slather ourselves in sunscreen every day before we walk out the door?   Should we not engage in outdoor activities that promote good health and well being, and which may be one of our key strategies to deal with the epidemic of overweight and obesity in this country?

The answer to that is a simple no. 

If we do elect to take a walk, play a sport, or go to the beach or the pool, we should pay attention to what the experts recommend for sun safe/sensible behaviors.  Using sunscreen, wearing a hat, wearing long sleeve shirts (when practicable), and wearing sunglasses are all recommendations that I believe are prudent.

It is also sensible to avoid the sun at the most intense times of the day, and if you must be outside during those times try to seek the shade.

But avoiding the sun at all costs, for most of us (there are people who are extremely sun sensitive) simply doesn’t make sense.

There is a simple index that is available that can give you a clue as to when the sun is too intense, and that is called the UV index.  The Australians and the Canadians pointed out during our discussions that this information is readily available in their country through radio and TV broadcasts, and I explained to them that it is much less available here.

But that doesn’t mean it is not a useful guide.  You can find the information on a variety of weather related sites, such as the Environmental Protection Agency.  A UV index of 3 or greater is the danger zone.

Given the fact that the sun is dangerous when exposure is excessive (the problem here is that some people think excessive means when you blister with a sunburn; to a “skin expert,” it is the dose of sun that is required to develop minimal redness in the skin.  That can be 30 minutes for me and 5 minutes for you, in no small part due to the type of skin you have and where you live), how does that relate to vitamin D?

Sun exposure is the one generally accepted means of getting vitamin D into our bodies. 

Fortified foods, such as fortified milk, are another.  There are some other foods that may contain vitamin D, such as certain types of fish, but my hunch is that most of us don’t eat those foods on a regular basis.  And, if a dairy product doesn’t specifically say it is fortified with vitamin D, it isn’t—and should be relied on as a source of vitamin D.  So those of you who like ice cream, sour cream, cottage cheese, cheese or whatever—if it doesn’t say fortified, it doesn’t have vitamin D.

The third source of vitamin D is vitamin supplements, which should be “vitamin D3” or cholecalciferol.  Other forms of vitamin D supplements don’t work as well. 

The potential problem here is the quality of manufacture of the vitamins and whether in fact they contain the vitamin in a formulation that will allow it to be absorbed by our bodies.

Also, if you take a multi-vitamin or a calcium supplement, check to see if and how much vitamin D is contained in the pill or liquid.

We know that vitamin D is proven to be good for musculoskeletal health and the prevention of fractures in the elderly.  It may also reduce the risk of certain cancers, including colon cancer (additional data has recently been reported in the Journal of the National Cancer Institute, and somewhat buried in the data from a recent report in the New England Journal of Medicine on a follow-up of the Women’s Health Initiative study).

We also know that we don’t know a whole lot about how much vitamin D we have in our bodies.  What evidence we do have suggests that those numbers are too low for many folks.  In particular, African Americans have a high frequency of vitamin D insufficiency, as do other people of color.

Now we come to the part that is difficult for many to understand.

If vitamin D is good for you, and exposure to the sun can be bad for you, what do you do?

What you do NOT do is seek the sun.  That would be absolutely the wrong message to send, and that is what has so many of us in the skin cancer prevention community so concerned.

In very real terms, what can be one person’s benefit can be another person’s poison. 

There are simply too many factors that have to be considered in making a “one size fits all recommendation.”  Factors to be considered include age, diet, skin pigmentation (as mentioned above), where you live (there is a big difference between Florida and northern Maine), and intensity of the sun (think Phoenix and Toronto in the summertime).

For some people, when we say a “small amount” of sun exposure, they may incorrectly interpret that to mean two hours.  For others, even 5 minutes of exposure in the wrong place on the wrong day can lead to a burn (I once got mild sunburn sitting at an outdoor restaurant eating a salad at lunch.  I have to admit that I was very surprised, to say the least, since I really didn’t sit there that long.).

So, although exposure to the sun may be an acceptable way to get vitamin D, it isn’t the safest way.  And if you decide to pursue this approach, make certain you use sensible behavior as discussed above.

And, above all, in my opinion and that of others, tanning beds are not acceptable ways to get vitamin D.  Put aside the risks of burning, and the harms of tanning.  The reality is that many dermatologists and others are very concerned about the lack of adequate controls on tanning beds, and the potential for long term harms of what is basically a social behavior.  In fact, the World Health Organization recommends that people under the age of 18 not be allowed to use tanning beds.  In my opinion, I can’t understand why anyone would want to expose themselves to a tanning bed.

For me, my recommendation is that supplements are the way to go, especially if you are in one of the categories “at risk.”  The elderly, exclusively breast fed babies, people who don’t get much time in the sun (like me and many of my colleagues whose only routine sun exposure is through the window at work), and those who live in the northern parts of the United States and Canada are examples of such groups who need special attention to their vitamin D intake.

But the right dose of vitamin D supplements still remains uncertain.  The consensus is that it is greater that the current recommendations of 200 IU/day up to age 50 and 400 IU/day through age 70, and 600 IU per day for those age 70 and older.  But we don’t know the answer yet.  One organization, Osteoporosis Canada, recommends 800 IU/day for adults over 50.

Also, we don’t know the truly toxic daily dose of vitamin D, which is now pegged at 2000 IU/day.

We still have much more research to do.  We need to know more about individual blood levels and how much vitamin D we need to maintain health.

We need to know more about what to recommend to the public about sun exposure.  The reality is that there are many variables to consider, so there is no likelihood that anyone can make a sound, science based argument that there is a single “sun prescription” that will be right for everyone in every place.

We need to know the long term risks of taking vitamin D supplements over a long time.

And we need to know the level of vitamin D that will reduce our risk of various health problems, including cancer.

The reality is that we know more about vitamin D and health today than we did a year ago.   But we still have much to learn.

But one thing has not changed over the past year, and that is our firm recommendation that if you decide to go outside, know the risks and protect yourself.  It’s up to you to be “sun safe and sun sensible.” 

Increasing your levels of Vitamin D is no excuse to ignore common sense.

During the extensive media coverage of the sad and untimely death of Dana Reeve from lung cancer, I was intrigued by the many experts who were interviewed on national news shows or in the newspapers and magazines proclaiming there was an epidemic of lung cancer in non-smokers. 

Invariably, the comment was made that lung cancer was becoming a particular problem for non-smoking women compared to men who were non-smokers.  This comment would then be followed with a series of theoretical discussions as to why this was the case, including genetic differences, hormonal susceptibility, and so on.

When reporters would speak to me, I told them I couldn’t substantiate these differences, and I wasn’t going to guess as to why non-smoking women were more susceptible to lung cancer than non-smoking men.

I can tell you I wasn’t comfortable with my apparent ignorance.  As it turns out, I may not have been so ignorant after all.

This week, colleagues of mine from our epidemiology department at the American Cancer Society and the University of California San Diego published an article in the Journal of the National Cancer Institute which is the most definitive analysis of lung cancer incidence in non-smokers.

Their conclusions?  Non-smoking men are at greater risk of getting lung cancer than non-smoking women, and non-smoking African American women have a greater chance of dying from lung cancer than non-smoking white women.

This discussion is important because lung cancer is the leading cause of cancer death in this country.  Of the people who die from lung cancer, somewhere around 85-90% of them are either smokers or former smokers (in fact, in the United States today there are now more former smokers than current smokers).

That means there are still many thousands of people in this country every year who die from lung cancer even though they never regularly smoked cigarettes.  My colleagues estimate this number is between 17,000 and 26,000 deaths a year from lung cancer in non-smokers.

The cause of these deaths, for the most part, has been attributed to a number of factors including second-hand smoke, smoking other forms of tobacco products, exposure to other carcinogens, and occupational, environmental and even medical exposures.

At various times over the past 45 years, the American Cancer Society has studied about 2.2 million people who have participated in two long term programs called CPS (for Cancer Prevention Study) I and CPS II.  These folks have been followed for many years, and their various habits, medications, and disease status have been reported and analyzed.  Their causes of death have been recorded and verified for accuracy.

What makes studies of this type so important is that the participants provide information prospectively.  That means we look at the people going forward, not retrospectively where we take a look backwards to figure out what the facts may be.

There is a lot less bias and much better recall of information in prospective data gathering, and the results have enabled my colleagues to report many breakthrough studies on various cancer causes and relationships which have been considered critically important in our understanding about the causes of cancer.

For example, a study they reported a couple of years ago established the link between the role of being overweight and obese with the significantly increased risk of developing a number of cancers in both men and women.  This breakthrough study allowed us to understand that obesity affects cancer risk just as it increases the risk of diabetes and heart disease, among other illnesses.

In the current lung cancer study, they examined the records from CPS I and II to find out how often lung cancer affects non-smoking men and women of both races. 

Of the 2.2 million people who participated in the two prevention studies, 940,000 were non-smokers.  The overwhelming majority of the participants were white.

The researchers found that in both studies the risk of dying from lung cancer was greater for non-smoking men than non-smoking women, although the differences were less more recently.

Although death rates from lung cancer for both sexes were higher in African Americans than whites, the only difference that appeared significant after making statistical adjustments was for increased rates of death in non-smoking African American women compared to white women.

Finally, there was no evidence that the rate of death from lung cancer in non-smokers has increased over time.

What does all of this mean?

Contrary to public perception and expert misinformation, there has been no increase in deaths from lung cancer in people who are non-smokers, and male non-smokers die more often from lung cancer than women.

This does not diminish the importance or the impact of lung cancers in non-smokers.  Lung cancer is a serious disease, and if lung cancer in non-smokers was ranked as a cause of cancer deaths, my colleagues say that it would be the sixth to eighth most common cause of deaths from cancer.

Why would people, including the experts, think that lung cancer was a more important issue for non-smoking women than men?

There may be many reasons, but the reality is that there simply were not studies available that had the strength of numbers and duration of follow-up that the CPS studies provided.  The researchers indicate in the article that it is difficult to obtain this information on as broad a basis as needed to ensure accuracy.

But there is another, perhaps more complicated reason why people have the perception that lung cancer is a more serious problem for women than men.

Historically, more men smoked than women.  That in turn means there are fewer non-smoking men than non-smoking women.  That means, numerically, there is a larger population of non-smoking women than men who would be susceptible to getting lung cancer.  The net result is more women do die from lung cancer if they are non-smokers.

But that is not the way we measure risk.  We measure risk by the number of people who die of a condition per 100,000 people (or men and women).  And when we measure the risk of dying from lung cancers for non-smokers, it is the risk per 100,000 that is important.  In this circumstance, the risk is higher for men than women.

As to why the situation is worse for African-American women than white women, we do not have an answer. 

Unequal access to treatment, differences in diet and/or exposure to environmental carcinogens, differences in rates of tuberculosis (a disease whose scars can result in an increased risk of lung cancer) or possibly underlying genetic differences are all reasons the researchers offer to explain their findings.

As time goes on, and more men become lifelong non-smokers, eventually there will be a larger number of non-smoking men dying from this disease.

As I have mentioned previously in these blogs, we need to do a better job of understanding lung cancer, and how to treat it. 

We need to acknowledge that for many the diagnosis of lung cancer is the result of an overpowering addiction that some have been able to overcome and others have not. 

We need to acknowledge that we must do a better job of reducing the risk of lung cancer for both smokers and former smokers alike, and we need to do a better job of understanding the causes of lung cancer in non-smokers.

But in all of this understanding, we need to do a better job of getting our facts right.  We need to be able to say, “I don’t know” when we really don’t know.

And, we should pay special attention to not letting our opinions get in the way of the facts, no matter how heart-rending the circumstance may be.

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The American Cancer Society's Cancer Prevention Studies described in today's blog have been of incredible value in our understanding of cancer and its risk factors.

We are presently in the process of recruiting volunteers who are willing to participate in our new CPS-III study which is just getting underway.

Recruiting is ongoing at our Relay for Life events in communities nationwide.

If you are interested in learning more about CPS-III, and especially if you are thinking about volunteering for this study, please go to our website, email us at cps3@cancer.org, or call us at 1-888-604-5888.

If you want to help and if you qualify, you will be part of something very special.

Thanks!

During this week when we celebrate the launch of the American Cancer Society’s 2006 Great American Eat Right Challenge, it’s a good time to revisit the fact that all of us could do a better job of taking care of our diet, our weight, and our health. 

And, I believe that many of us understand the sense of accomplishment that comes from setting right something that has gone wrong with ourselves.

In that context, there are some messages I feel strongly about, and I would like to share them with you today:

·        Just because you are a doctor and believe in prevention doesn’t mean you necessarily follow your own good advice.

·        Even people like me, who are supposed to know better, can lose their way on the path to staying healthy. 

·        Ultimately, it’s not that you have fallen off the wagon that counts.  What counts is that you get back on.

Maybe what has happened to me recently will strike a chord with you or someone you know, and move them along to commit to improving their own health.

There is a euphemism about tall people who are overweight: “they carry it well.”  So when you are tall and overweight like me, you frequently may not look like it.

Despite my height, I have always had a problem with my weight, starting from when I was a young child.  I knew that being overweight had its set of risks, and despite a regular exercise program and trying to “eat right,” my weight generally was higher than it should have been.

Theoretically, I should have known better.  I have a family history of obesity and hypertension.  I lost my father to hypertension and kidney failure when I was very young.

When you are younger and you concentrate on weight loss, it tends to be an easier proposition to lose a few pounds, especially (or so it seems) if you are a man

As you grow older, at least in my experience, forget about it!!!!  Diet, exercise, more diet, more exercise—it never seems to work as easily as it used to.

So you start to remove some of the offenders from your diet: chips and dip, burgers and fries, peanuts and popcorn, ice cream—you know the litany of things you try to cut out of your daily eating regimen when you want to lose those “unsightly pounds.”

You try a variety of diet regimens.  Scarsdale, Atkins, grapefruit, magic over-the-counter pills that get rid of ugly belly fat. 

Short term successes, but no long term results.

And, still the pounds pile on and on. 

Somehow the diet plans don’t work as easily as they used to.  Exercise becomes more miss than hit (as in “hit or miss”).  Your job and your life become more sedentary.  Even parking further away from the grocery store so you walk more doesn’t do the trick.

In my situation, there was another major variable, and that was travel and meetings.  Lots of travel, lots of meetings, lots of missed or irregular meals and virtually no control of your diet while on the road.  Too many social hours, too many snacks

There are those chocolate chip cookies or some such delight which seem to be everywhere.  After hours in a meeting room, what harm is a cookie going to do?

The answer: plenty of harm.

I truly believe it is not massive overeating that gets us.  It’s a little bit extra every day, day after day.   And then the you-know-what accumulates around your waist or your thighs, depending on your genetics and your sex.

Personally, I did pretty well until my fifties.  My blood pressure was normal, as was my cholesterol.  I remained in good health, my weight notwithstanding.

But then my life changed a bit, with an increasing amount of travel and various forms of stress. And the pounds slowly but surely piled on.

Instead of exercising every day, it became a couple of times a week.  I tried to maintain an exercise schedule on the road, but that didn’t work out (pardon the pun). And then exercise became a luxury (or so I thought) because I simply didn’t have time.

About a year ago my body started heading south—literally and figuratively.  Pain in my foot limited my ability to walk or exercise.  Fluid in my arm required drainage.  

And then one day last December I ended up in the doctor’s office with severe pain and swelling in my knee and we discovered my blood pressure was somewhere between high and higher.

That was a horrible day for me.

Let’s face the facts.  I am a physician who believes in prevention.  I have made prevention my mantra my entire professional life.  I have preached prevention to my patients, and I have preached prevention in my lectures. I have preached prevention every chance I get.

There is at least one person I preached to who did not get the message: me. 

Here I am, sitting in the doctor’s office, and I am making a rapid transition from being a doctor to being a patient.  And it was not a happy or comfortable transition to make.  I also discovered that my cholesterol was up to unacceptable levels, and I likely had gout.

Medically, I had become my dad.  And that was not a pleasant thought.

There are two ways to face a challenge in life: ignore it or take it on.  Being the optimist that I am, despite my age, I chose the latter over the former.

In fact, that day in the doctor’s office was in a real sense a rebirth for me.  It was a day that I made a commitment never to be in that situation again.  If I was going to get sick, it was going to be on terms over which I had some control.  I never wanted to be in a place where I knew I had not done my best to take care of myself.

All of us are going to become ill, and, yes, all of us are mortal.  There is much about our health over which we have no control.   We are born with genetic pre-dispositions and family histories that in part direct our fate.

But we are also born with the ability to direct many of the factors that influence our health and our lives.

So although we may be prone to various diseases, in many circumstances we can influence what happens to us medically.

For example, we know that being overweight and obese increases our risk of heart disease, diabetes, elevated cholesterol and stroke.

But did you know that being overweight and obese also influences our risk of cancer?  The reality is that it does, and not many of us know it.

The American Cancer Society estimates that almost 2 out of 3 cancer deaths could be prevented if we just did took some simple steps: don’t smoke (1/3 of cancer deaths), eat a healthy diet, be physically active, and maintain a healthy body weight (the other 1/3).

This begins the good part of my story.

After sitting out a good portion of my Christmas vacation while the dose and number of my blood pressure medications increased, my wife (who is also a physician and shares the same problems I do when it comes to weight and exercise) and I made a joint commitment to do something about our state of affairs (actually, she had previously made her commitment a couple of months before my event, but we both pledged to support each other in our efforts).

We knew the holidays would be a difficult time under the best of circumstances, but we managed to change our dietary habits and patterns, and begin a regular physical exercise program.

We made what changes we could to our schedules to be certain we exercised virtually every day. We worked hard to limit our portions, and eat better foods (we have done better with the foods than with the portions).  We increased the fruits and vegetables we eat every day (five a day is no longer a challenge for me).  We reduced the salt in our diet (although when we travel, we inevitably “get salted”, which is somewhat like “getting slimed” on those kids shows—you never know when some chef somewhere is going to “salt up” the food without you knowing it).  We have substituted sliced tomatoes and a single slice of whole wheat toast for bacon and grits with butter on our Saturday morning breakfast at Waffle House.  We have become occasionally obnoxious when we give our orders to a server at a restaurant as we change the ingredients and the side dishes (as in, “Please put the sauce or the salad dressing or the whatever on the side, thank you.” Once I almost leapt at the chef making my omelet when he started to put some cheese on top of my Egg Beaters.).  I record my daily diet and exercise programs in my Weight Watchers online program.

You get the idea.

I believe most of us know what we should be doing to eat a healthy diet.  Most of us know where our problems lie.  Most of us know we should be getting more exercise.

But it is difficult to do.  It is a commitment.  It is one step at a time.  And it is slow.

As someone once told me, life is a journey, not a sprint.

There is an editorial that hangs over my desk, which discusses the value of weight loss.  It basically says that for those who make the commitment, who can take the time it takes, who can overcome the many barriers that inevitably fall in one’s path--for those people the benefits are immeasurable.

So here are the results:  My cholesterol is now down to very satisfactory levels.  I have reduced my blood pressure medicines from three to one.  I can walk without pain.  I have been able to exercise at least 5 days a week, frequently for at least one hour.  I have lost about 20 pounds.

My wife and I still have a long way to go, but we are both personally proud of our accomplishments over these past six months.

We aren’t perfect, and we still have lapses.  But those lapses are fewer than they were, and they don’t prevent us from facing ourselves every day, and trying to be better today than we were yesterday, and better tomorrow than we were today.

So this week, make the commitment to do something for yourself, and for your family.  You may have tried before, just like me, and not been successful.  Don’t be discouraged, because bad habits are hard to break.  It may take many efforts to achieve success.

Set some simple goals.  You can’t remake yourself in a day or a week or a month.  Your health and your body are long term investments, with short term gains along the way.

This is an investment, after all, where the returns are found when the numbers go down, not up.  And, they will go down!!!

We wish you every success as you begin to create your own culture of health.

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For more information on the American Cancer Society’s 2006 Great American Eat Right Challenge, go to our website at www.cancer.org/eatright 

For years I have had at least one consistent answer to the question, “What is the single most important thing I can do about my health?”

And the answer is, “If you are a smoker, stop.  And if you are not a smoker, don’t start.”

But the  major barrier for smokers who want to quit, despite all of the news and information about the incredible dangers of cigarette and cigar smoking, is the fact that cigarette and cigar smoke is so incredibly addicting.

Once hooked, many people simply can’t do anything about it.  That’s not their fault, given the fact that the nicotine in cigarettes and cigars is one of the most addicting substances we know of.

Today, a new form of targeted therapy has been approved by the Food and Drug Administration that may just be the answer for many chronic smokers who have failed quit attempts in the past.

The name of the drug is varenicline (trade name: Chantix) that has been developed and will be marketed by Pfizer.

The reason so many of us are hopeful about this new medication is because it has a different mechanism of action than other smoking cessation aids such as nicotine patches and gum (which provide the body with nicotine without the dangerous cancer-causing substances found in cigarette smoke), and the medication bupropion (trade name: Zyban) which is an antidepressant that has a particular anti-smoking effect not found in other antidepressants.

Although the mechanism of nicotine addiction is a complex process in our bodies, understanding how it works is relatively simple.

People who smoke become addicted to the nicotine.  No cigarette, no nicotine, and about 4-6 hours after your last puff you need another fix.

That is a classic addictive behavior process.

What happens is that we have something called a nicotine receptor that is located in several parts of our brain.  According to a recent article in the International Journal of Clinical Practice, there are an increased number of these receptors in the part of our brain that deals with what we can call “pleasurable responses.” 

When you inhale nicotine, it travels through your body into your brain and latches on to these receptors.  That then stimulates the brain cell to which the receptor is attached to secrete a substance called dopamine.  When the amount of dopamine in the spaces around the cells in this part of the brain increases, the smoker feels good.

Voila! Another chronic smoker is introduced to the habit.

As people smoke, according to the author of the article, the number of nicotine receptors in the brain increases, as does the pleasurable response.  This is all associated with a “learned behavior” of connecting the functions associated with smoking a cigarette with the sense of pleasure.  We learn to relate the opening of the pack of cigarettes and lighting the cigarette with the pleasurable response that is going to follow.  And we learn that there are certain things we do, such as smoke while drinking an alcoholic beverage or eating a meal, will also result in the same effect.

This is all very complicated, but the net result is that a number of changes occur in our bodies and our brains that create habits that can be very difficult to change without a very concerted effort.

Varenicline is a new approach to dealing with this problem. 

As I mentioned before, we can provide nicotine substitutes and antidepressants.  But varenicline is actually a targeted therapy, based on principles similar to the targeted therapies I have discussed in other blogs (for example, Herceptin) except in this case it is targeting a receptor on a nicotine-vulnerable cell as opposed to a cancer cell.

The net effect is the same: block the receptor with varenicline, and the nicotine can’t get to the receptor and can’t cause its triggering effect on the dopamine levels in our brains.

However, varenicline itself does stimulate the production of dopamine, so there is still some of the same positive feelings that nicotine would produce.

So, in effect, you can get the boost you need similar to what you would get from a cigarette without having to smoke a cigarette, or taking a nicotine substitute for that matter.

In essence, the chains of dependence are broken.

But that is not all you would have to do to be successful with this new medication.  You also need to learn to break the other bad habits that reinforce your dependence.  You need to avoid places you associate with smoking (such as bars and restaurants), or at least have to learn how to deal with those stimuli and challenges.

Programs such as the American Cancer Society’s Quitline ™ are designed to help you with your efforts, and Pfizer has announced they too will provide a support program.

How successful will varenicline be?

We really don’t know the answer to that as I write this.

According to information I have been provided, this drug was tested in relatively healthy smokers (if there is such a thing) who had no cardiac disease or problems with depression.  The smokers in the clinical trial spanned a reasonable age range similar to typical smokers.

According to a Pfizer news release, 20% of smokers who used the medicine remained smoke free for over a year.  The drug was four times as effective as a placebo, or dummy pill, and it was twice as effective as bupropion.

That may not sound like much, but it is fair to say that many of these folks had made multiple attempts to quit (we need to remember that, like any difficult habits, stopping smoking can take many, many attempts until you are successful.  Pfizer says it takes on average 10 quit attempts before a smoker is successful in stopping).

We also need to remember that smoking is an addiction, and a chronic disease.  So it is one that will be with a smoker for a lifetime, and the cravings don’t quit even many years after stopping.

So if we have a population of folks in this country who are hard core smokers (22% of our population, or 45 million Americans smoke) and we are able to keep 20% of them off of cigarettes for a year, then that is probably a considerable success under those conditions.

And, if the first effort isn’t effective, and they keep trying, eventually the odds are they are going to be successful.  Over half the people in the United States who ever smoked and are alive today are former smokers.

What about side effects? 

The official Food and Drug Administration announcement says the most common side effects are nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams and a change in taste.

The frequency of nausea is not insignificant, and affected a majority of the participants in the clinical trial for a number of days after they started the medicine.  That said, if the participants continued the medication, the nausea did resolve.

The bottom line is that the news of varenicline’s approval today is exciting.  How quickly this medication is going to work its way into clinical practice is uncertain at this time.

We need to make a much better effort as doctors and clinicians to remind our patients about the dangers of smoking, and encourage them to quit.  We need to provide and take advantage of the resources and medications available to smokers to help them stop smoking.  We need to create environments (such as through clean air laws) where smoking is prohibited.

This new approach to smoking cessation is probably going to fairly quickly become part of our treatment programs if we are able to get folks into their doctors’ offices and have the doctors work with them by prescribing the medication and getting their patients into support programs.

But there are some cautions in my opinion that we also need to be aware of.

Recall that I mentioned above that the smokers in the clinical trials were relatively healthy.   That makes them a select population of folks who smoke.

When we get into the real world with any new medication we have large numbers of people taking it who are not subject to the careful monitoring that occurs in a clinical trial.

That means that people with lung disease, heart disease, diabetes, hypertension and depression to name but a few conditions are going to be taking this medicine.  That also means they will be taking a number of other medications at the same time.

Although it is obvious that the experts who developed the drug are knowledgeable about these considerations and have taken this into consideration, I always am a bit cautious about any new medicine and its potential other unanticipated side effects that may be found as the medicine becomes part of standard clinical practice. 

If you are a “healthy” smoker similar to those studied in the clinical trial, you have a reasonably good idea of what to expect from varenicline.  If you have many other serious medical conditions and take a number of other medications you need to be aware of any additional symptoms you develop if you start the medicine.

This advice is no different than I provided my patients when I was in practice, and is not unique to this medicine.

Many medicines have come to market and been extremely effective.  But I have learned from experience that we do not learn everything we need to know about a drug like this from a clinical trial.  The consequence is that “post marketing surveillance” is very important.

(By the way, as a piece of general information, if you have any unusual side effect from any prescription medication, you or your health care clinician can report it directly to the FDA on their website at MedWatch.

My sincere hope is that this medication is effective in helping those who are chronically addicted and possessed by their smoking habit.  We need new advances like this to help these folks achieve the goal that many of them desire.

Time will tell if it is as effective as the studies suggest.

In the meantime, call us at 1-800-ACS-2345 24/7 and talk to us if you are ready to make the attempt, even if you have not been successful 10 times before.

It seems as though we have been bombarded with estrogen stories over the past several months.

It was just a couple of weeks ago that I discussed a report from the Women's Health Initiative that estrogen-only hormone replacement therapy in post-menopausal women did not increase the risk of breast cancer.

Now there is a new report published in the Archives in Internal Medicine yesterday which has the potential to add to women’s confusion regarding the risks of estrogen therapy to treat menopausal symptoms.

The headlines may say that the study shows that estrogen increases breast cancer risk.

My interpretation is that in fact the study gives us information that rounds out our knowledge about the risks of estrogen and breast cancer, and confirms that if the drug is used as intended there is less cause for concern than was the case previously.

The study provides information on the breast cancer risk of 28,835 women in the Nurses Health Study, a long term follow-up study of nurses conducted by the Harvard Medical School and the Harvard School of Public Health.

These outstanding and highly regarded investigators have reported numerous studies on the various groups they have followed over time including nurses, doctors and other health professionals.  As a result, we have learned much about what impact various factors, such as estrogen therapy, have had on the incidence of cancer.

In this particular study they examined the breast cancer rates of post-menopausal women who had taken estrogen continually over various periods of time as compared to post-menopausal women who never took the medication.

All of the women in the study who took estrogen had had a hysterectomy. 

The women were followed from 1980 through 2002.  At the beginning of the study, there were 11,508 women participating.  Additional women who started estrogen therapy and/or had become menopausal were added every two years as further updated information was obtained.  By the end of the study, almost 29,000 were included.

A “snapshot” of the women who were in the study as of 1990 showed that almost 4500 of the participants had taken the medication for over 10 years.  3255 of the women had taken estrogen replacement for less then 5 years and 5006 women had taken estrogen for 5 to 10 years.  3288 women never took estrogen.

Some of the women had taken estrogen for 20 years or more.  If that seems strange to you, you are correct in your observation.

That change in perception about the value of long term hormonal replacement therapy has occurred over the past 4 years since the publication of the original Women’s Health Initiative study in 2002. 

We need to recall that prior to the publication of that article, there was a general consensus among physicians that hormonal replacement therapy for menopausal women not only helped them feel better, but it also had several health benefits as well.

The WHI trial demonstrated that was not the case, and a series of articles have confirmed that the consensus of experts and practicing physicians was plain incorrect.  In fact, HRT had detrimental or no effects for a number of conditions, and there were associated dangers of using the medication including an increased risk of breast cancer in women who took combined treatment with estrogen and progestin.

The results were dramatic, and the usage of the medications dropped dramatically.

As a result, the new consensus is that these medications have risks, and should be used only for symptom relief and for the shortest time possible.

Although some women may remain on HRT (including combined therapy for women who have not had a hysterectomy, since the progestin part of the regimen reduces the increased risk of uterine cancer that occurs when only estrogen is used in women whose uterus has not been removed) for a long time because they have difficulty functioning without it, the reality is they do so with an understanding that there are definite risks.

So what did the investigators find in the new Harvard study?

Basically, a post-menopausal woman on estrogen-alone treatment does not have an increased risk of developing breast cancer until she has taken the medication for more than 10 years.  Beyond that time, there is a trend of increasing risk of developing breast cancer, but the authors could not say with certainty that the risk increased until a woman had taken estrogen therapy for 20 years or more.

For women taking estrogens for 10 to 19.9 years, the authors found a “suggestion” that the risk was real, and it would be inappropriate to conclude that there was no increased risk.  But the statistics were simply not conclusive enough to say that the increased risk was real.  For these women, it would be wrong to ignore this concern, however.

To put it into other terms, for women who took estrogens for 10-14.9 years, there was an average 5% increased breast cancer risk.  For women on the medication for 15-19.9 years, there was a 19% increase in risk, and for women on estrogens 20 years or more there was an average 41% increased risk of developing breast cancer.

The other interesting observation was that thinner women taking estrogens were at greater breast cancer risk than overweight or obese women who took the hormone replacement. 

This may be because overweight and obese post-menopausal women are known to have higher blood levels of natural estrogen.  Therefore, the impact of additional estrogen from pills would have a greater net effect on the thinner women, thus increasing their risk of breast cancer.

This latter observation is interesting to me, since in a recent blog on the effects of hormonal replacement in African American women based on a report also published in the Archives of Internal Medicine had a similar finding.

So what should you do?

My first recommendation, as always, is to talk with your doctor or health care professional if you need hormone replacement therapy.  The discussion should be open and honest, and you should have a clear understanding of the potential risks and benefits that pertain to you.

You probably shouldn’t take hormone therapy if you don’t have to.  There are safer drugs, for example, to treat osteoporosis.

If you do need to take hormones, you will be prescribed a combination of estrogen and progestin if you have not had a hysterectomy, and estrogen if your uterus has been removed.

For either medication, use it only for the shortest time possible to control your symptoms.

Although there may be some benefits from hormone replacement (such as for some women a decreased risk of breast and colorectal cancer), the potential harms far outweigh those benefits.

And if you are on long term therapy with either estrogens or combination treatment, talk with your doctor whether or not you can stop them.

What we do know based on the evidence available to us is that taking hormones to improve your health is not “good medicine” based on current recommendations.  It is a symptomatic treatment, and that is the only generally accepted indication at this time.

And, although some experts believe that the data from the WHI needs to be reexamined for a variety of reasons, there is no reason today to ignore what we already know when it comes to the safest use of these medications.

Once again, if you do have to take estrogen alone for whatever reason, increased breast cancer risk is no longer a major concern for many women, but only if you are taking the estrogen for a limited period of time.

Hopefully, as these studies have accumulated, we now have a much better, consistent and scientifically sound basis for what we tell our patients about the benefits and risks of hormonal replacement therapy.

An article in the Wall Street Journal earlier this week caught my attention.

It discussed the current use of the targeted therapy Herceptin as an adjuvant treatment for breast cancer, and how is faring in the marketplace both in the United States and in Europe.

The article highlighted for me the stark contrasts between how we approach the availability of new medicines and new indications for established medicines in this country and in the rest of the world.

Those differences are real, and have implications for the type of health care and health insurance “system” we are willing to accept in this country.

Herceptin is probably the first real targeted therapy drug.  It is a drug that, until recently, was used solely to treat women who had recurrent breast cancer, and whose breast cancer tissue contained a gene called “HER 2.”  It is a very expensive drug.

Women with an HER2 positive breast cancer generally have a poorer prognosis than women without this genetic marker, and tend to relapse sooner after primary treatment for their cancer even when they receive appropriate adjuvant therapy.

You may recall that last year there were presentations at the American Society of Clinical Oncology meetings regarding the use of Herceptin as part of adjuvant treatment studies in women who were HER2 positive.  These research papers were subsequently published in the New England Journal of Medicine, and commented on in this blog.

The results were stunning, reducing the risk of recurrence by about half.  Doctors whispered about the possibility that this might actually represent a curative treatment for these women, something that was unheard of prior to these studies.

Doctors were excited about the results, and there were comments made that this would change the standard of care for treatment with this type of breast cancer literally overnight.

Now it is one year later, and the question is whether or not women are getting the benefit of this breakthrough in the treatment of breast cancer. 

It is also an opportunity to reflect on the different approaches regulators and health insurers take in the United States and Europe, and what the deeper implications are for the care provided to patients in these different locations.

After the presentations at ASCO, the manufacturer of the drug applied for a new indication approval both in the United States and in Europe.   

The Genentech website made the announcement of the submission to the Food and Drug Administration (FDA) on February 15.  The hope is that the FDA’s approval decision will be made by August.

According to the Journal article, the European commission that reviews new drug requests approved the use of Herceptin as an adjuvant therapy last week with final approval within “a few months.”

In the meantime, until that final approval is obtained, women in Europe have essentially no access to the drug.  In contrast, women in the United States at least have the possibility of getting this medication which, for many of them, may be lifesaving.

Why the difference? 

The answer to that question highlights not only the cultural differences between Europe and the United States and how we pay for health care, it also puts the spotlight on a debate that is currently ongoing in this country of which new medications we should receive and when we should have access to them.

Approving drugs and getting them to market is complex and lengthy.  Essentially, a new drug is studied during which time its benefits and risks are assessed.  The manufacturer then goes to the FDA and seeks the agency’s approval to market the drug as “safe and effective.”  Once the FDA says OK, the manufacturer can proceed with selling the medication.

The interesting part, especially when it comes to cancer treatment, is that the company may only study the drug in one or two particular cancers.  But, the research doesn’t stop at the initial trials and it is very possible that the drug may be studied further and found to be effective in other cancers or other conditions.

If that is the case, based on the literature and reports at scientific meetings, doctors in the United States may start prescribing the drug in an “off label” status.  Basically, that means that the doctor has decided the drug is good for the patient but the FDA has not approved the drug for that particular indication.  Traditionally, at this point, the manufacturer can decide whether they want to submit an application for approval for the new indication, or not make the investment in such a project.

In Europe, for the most part, there is no “off-label” status, because national health systems will only pay for those drugs which have been approved by the health care regulators in that country.

Essentially, equal access for all usually means no access for everything else if the national health system hasn’t given a particular drug its blessing.

In this country, as we have moved into increasing regulation and monitoring of the distribution and use of medicines by managed care organizations, and because of the increasing costs of many of the newer medicines, government and private insurers have become increasingly strict in what drugs they will pay for.

Generally, if a drug is approved by the FDA most companies will pay for it if it is on their formulary.

But when it comes to off-label usage, there is no generally accepted rule of what should be covered and what should not be covered.  What a doctor thinks is good for the patient is not necessarily the case in the eyes of many insurance companies.

The end result is that there is no national standard about what is acceptable treatment and what is not, if some of those drugs are “off-label”.

The use of Herceptin in the adjuvant treatment of breast cancer remains “off-label” as of this writing in the United States.  That means that women covered by private insurers may or may not have access to the treatment through their insurers depending on the decision of that particular company (the drug is way too expensive for most of us to afford it without insurance coverage).

Medicare coverage is dependent on what is called local coverage decisions.  This means that each Medicare carrier in different parts of the country makes a determination about whether or not Herceptin for the adjuvant treatment of breast cancer is a medically necessary treatment.  (Contrary to what most people think, most Medicare coverage decisions are actually made through this “local” level review.  However, this process is no longer really local since many Medicare carriers now cover several states.  A minority of coverage decisions are made through a uniform national process.)

If the FDA approves the indication, then probably most if not all carriers would cover the treatment, and they may do so right now. 

The problem today is that there is no place you can go to easily find out how each of the Medicare carriers (and for that matter, state Medicaid programs) has ruled on this coverage.

The end result of all of this is that we have no way of knowing in the United States who has access to Herceptin and who does not.  And we certainly have no idea of how women who have either inadequate health insurance or no insurance are coping with this situation.

How do the Europeans deal with this dilemma?

Most (if not all) European countries have national health insurance programs run by the government.  According to the Journal reporter, their decisions are easier: no approval, no coverage.  One advocate told the reporter that in England the government is using any excuse not to provide Herceptin for adjuvant breast cancer treatment because of the medication’s cost.

If and when approved by the European commission there will be another level of scrutiny awaiting Herceptin in the United Kingdom.  The National Health Insurance system has to make a decision whether the cost of covering the drug is justified by the benefit.  For the Brits, it is basically a zero sum game: put more money into the treatment of cancer and you may deny other folks access to more basic services.

In fact, there was an editorial recently in the well-respected British medical journal The Lancet which advocated for NOT covering Herceptin.  Whether or not the cost factor influenced the editorialist remains uncertain.

In the meantime, women in Europe are apparently having a very difficult time getting access to this expensive but effective medication.

So that brings us to some fundamental questions: Which system would you prefer?  Who ultimately should have the final say in your health care: you or your insurer?

Would you be willing to forgo this treatment because a national health plan said “no” to everyone, or have multiple private and governmental payers making that decision, and offering you the option of paying for the medication on your own if your insurer said no, and you could afford the medicine?

We have a problem reigning in health care costs in this country because for many of us we want and expect access to the latest therapies and medical advances.  And we want it now.  We don’t want to wait, and we don’t want to be told “no.”

Neither the European nor the American health care systems are perfect.  Both have their benefits and both have their drawbacks.

But the Herceptin example highlights some of those differences.  At least in this country, there remains some option of getting access to Herceptin for adjuvant treatment.  For European women, there are few options.

Ultimately, and perhaps in the not too distant future, we are going to have to make a decision in this country which option is best for us.

I spent much of the past week sitting in a room participating on a committee that advises the Medicare folks on their physician fee schedule.

I enjoy my work on this committee, but thinking about how we as a society are going to pay for the many new procedures and technologies we discuss can be daunting.

During the meeting I had a chance to get an early look at a report on Medicare spending patterns for 2005.  I was particularly interested in the costs of chemotherapy drugs.

It was not a pretty picture. To be honest, it was somewhat depressing.

Medicare, in my opinion, is going to face a real challenge in getting adequate funding to pay for the newer cancer chemotherapy drugs while still providing all of the medical services that doctors order and patients and their families have come to expect.

There are two parts to the Medicare program.  Medicare Part A covers hospital costs, and Part B covers physician visits and chemotherapy drugs, among many other services.

Part A costs are covered by the Medicare program.  Part B is supported 25% by the monthly premiums that are paid by the beneficiaries and 75% out of general tax revenues.

Part B is what we call “budget neutral.”  That is, if one part of Medicare Part B becomes more costly, then physician payments go down to make up the difference. 

There is every reason to believe that the costs of Medicare services including the drugs the doctors give in their offices and the tests they order are going to continue increase in cost every year.

That means, according to law, the monthly premiums paid by the beneficiaries will have to increase.

And, payments to doctors will decrease every year.  As a result, Medicare patients may have increasing difficulty finding a physician who will treat them.

Not every Medicare cost went up last year.  The cost of drugs given in doctors’ offices and covered by Medicare actually went down a bit (by 3%) due to new payment rules that took full effect in 2005. 

Doctors used to be reimbursed at what was called the average wholesale price for their drugs.  It turned out they could buy them in many situations for much less than that.  The difference either allowed the doctors to provide more services in their offices, or take a higher salary. 

In 2004 that began to change, and in 2005 the payment for drugs was the average sales price—the actual price the drug companies and their distributors charged the doctors—plus 6%.   This brought the Medicare payment for the drugs much more in line with what the doctor actually paid, thus reducing the doctors’ profits from the sale of drugs.

But that decrease is only a temporary one in my opinion, as targeted therapies and other expensive chemotherapy drugs are more widely accepted and used, and as more of these drugs are used to treat cancer.

For example, 2005 was the first year that Medicare provided data on how much they spent on some of the newer chemotherapy drugs.  And those amounts are nothing to sneeze at:

Bevacizumab    (Avastin)          $280 million

Bortezimab       (Velcade)         $73 million

Cetuximab        (Erbitux)           $112 million

Pemetrexed      (Alimta)            $91 million

I expect these costs to increase significantly next year.

Other drugs that have been around for a couple of years have a significant impact on Medicare costs as well.

Epoetin alpha (Procrit) and darbepoeitin alfa (Aranesp) which are used to treat anemia in cancer patients cost Medicare a total of $912 million.  (That number would have been higher if the new drug payment rules had not gone into effect.  In 2004, the total for these two drugs were $1.04 billion.)  That is close to 1% of the ENTIRE Part B budget in 2005 going to one type of drug.

Spending on rituximab (Rituxan), a drug that is used to treat lymphoma and has recently been approved in the treatment of rheumatoid arthritis went from $595 million in 2004 to $787 million in 2005.

Some drugs went down significantly in price. That is particularly true for the drugs used to treat prostate cancer, which decreased in cost by over 50% for the Medicare program. 

My prediction is that in 2007, those costs are going to start increasing once again since the major savings from the new drug payment rules have already been realized.

What I don’t know as I write this is what the impact of all of this will be on Part B premiums charged to beneficiaries. 

Because of all of the increased costs of the Part B program, that number is likely to be significant.  It is now $88.50/month, and there is talk of it going over $100 which is likely going to be very unacceptable to politicians and beneficiaries alike.

I know this is complicated information.

But I suspect you get the message: we are going to face a significant increase in the costs of treating cancer and I am not certain where the money is going to come from to afford this care.  This is particularly true for the Medicare population.

We need to get a better understanding of the impacts of these costs, so we can put real faces together with some of these numbers. 

And then we need to figure out how to be certain that people who need care can get it, without bankrupting themselves, their families and everyone else who needs medical care.