Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

The American Cancer Society

Let's Get It Right About MRI In Breast Cancer

by Dr. Len March 28, 2007

An article in a major newspaper this morning confirmed a concern that I had regarding how the media might interpret the guidelines the American Cancer Society released today regarding the use of MRI as a screening tool for women at high risk of breast cancer.

The headline said that women at high risk of breast cancer should use MRI as a screening tool instead of mammography.

Simply stated, that is not correct.  MRI is intended to be used in addition to mammography to screen women at high risk of breast cancer.

I quickly checked someof the articles that appeared in other newspapers, and they got the story right.  But I remain concerned that the continued importance of mammography as a screening tool in women at high risk will get lost in the discussion.

So, let's be clear: the American Cancer Society is not recommending that MRI be used in place of a mammogram in women at high risk, but is to be used as a complementary test in this situation.

I hope this information is helpful in understanding the continued importance of mammography in addition to MRI as a screening tool in women who are at high risk of breast cancer, as detailed in the paper published today in CA: A Cancer Journal for Clinicians.

 

MRI In The Early Detection Of Breast Cancer

by Dr. Len March 28, 2007

 

Two reports—one in the New England Journal of Medicine and the other in the American Cancer Society’s CA A Journal for Clinicians—have been published that will go a long way towards helping patients and doctors make reasoned recommendations regarding the appropriate use of MRI as a screening tool for breast cancer. (Links for these articles were not available at the time this blog was posted.)

 

We have known for some time that mammography has its limitations, especially in the evaluation of certain groups of women.  We have also known that MRI, which is an expensive and occasionally distressing test, can sometimes pick up early breast lesions that might otherwise be missed by conventional mammography, even when done by very competent radiologists.

 

As good as MRI might be, it also has significant limitations.  Chief among those limitations was the fact that MRI picks up many lesions in the breast that turn out not to be cancerous, requiring additional biopsies that may otherwise have been avoidable.

 

Although the increased risk of what we call a false positive lesion might be acceptable in some women at high risk of breast cancer, it would not be acceptable if applied to the population at large.

 

As experience with MRI has progressed, and as the techniques became more refined and additional tools such as MRI-guided breast biopsy have become available in some parts of the country, it became appropriate to revisit some of the questions about MRI and its appropriate use as a breast cancer screening tool.

 

The article and an editorial in the New England Journal discuss recent research in evaluating the effectiveness of MRI in women who themselves have already been diagnosed with breast cancer.

 

As the authors of the paper note, a woman with a diagnosis of breast cancer in one breast is known to be at increased risk of developing breast cancer in the opposite breast.

 

If doctors could find that breast cancer at the same time as the original diagnosis in the primary breast (instead of at a later date which is all too frequently the case), then it could mean a single episode of treatment for both cancers, instead of having to come back and retreat a woman at some time in the future when the second breast cancer appeared.

 

In addition, if the MRI could provide some level of reassurance that no cancer is present in the opposite breast, it may influence some women and their doctors not to do a prophylactic—or preventive—mastectomy on the breast opposite from where the original cancer was diagnosed.

 

The researchers represented a panel of 25 institutions and private practices that specialized in MRI of the breast.

 

They examined the results of doing a breast MRI in the breast opposite (or contralateral) to where the primary breast cancer was diagnosed in 969 women who had recently been diagnosed with breast cancer.

 

None of these women had a breast cancer detected by mammogram or clinical breast exam before the MRI was done.

 

The researchers found a total of 33 breast cancers in the contralateral breast with MRI within 1 year after entry into the study.  30 of these were the result of a positive breast MRI examination.  Three were not found on MRI: one in a woman who had a biopsy of a lesion that was reported to be probably benign on the MRI, and two in women who had a prophylactic (or preventive) mastectomy of the contralateral breast where the MRI was read as negative for cancer.

 

All three of these cancers were ductal carcinomas in situ, which means they did not invade the breast tissue and were very early cancers.  They measured 1, 3 and 4 mm in diameter (There are 254 mm in an inch, so they were very, very tiny cancers.)

 

Looking at the data another way, the doctors recommended a biopsy based on a positive MRI scan in 135 women (or 13.9%), and 121 had the biopsy performed as recommended.  Of these, 30 (24.8%) of the biopsies showed cancer.  91 of the lesions biopsied were benign.

 

For the 30 cancers diagnosed by MRI, of the 27 were information was available, none had lymph node involvement.  The average diameter was 1.09 cm (again, an inch is 2.54 cm).  96.7% of the cancers were stage 0 or stage 1, which have an excellent prognosis, and one cancer was larger and was stage 2.

 

The authors concluded that their study showed that MRI can improve the detection of breast cancer in the contralateral breast in a woman who has just been diagnosed with breast cancer, even when a mammogram and clinical examination is negative.

 

The editorial which accompanied the article in the New England Journal (written by Dr. Robert Smith, who is my colleague at the American Cancer Society) noted the progress that has been made in the early detection and treatment of breast cancer over the past 14 years from 1989 through 2003.

 

Dr. Smith also emphasized that to a woman with recently diagnosed breast cancer, the knowledge that there is a low likelihood of breast cancer in the opposite breast is also a matter of great importance.

 

The editorial extends the discussion, however, to another topic that is also crucial when it comes to the use of MRI in the early diagnosis of breast cancer, and that is making certain that this valuable test is used only for women for whom it may have the most benefit. 

 

In short, this is not a test to be applied routinely to all women at this time in place of a mammogram.

 

Perhaps you have seen some of the ads advertising breast MRI imaging centers as being superior to mammography.  This is probably more common in large cities like Atlanta and elsewhere, and less common in rural towns where it is less likely that the expertise and equipment to perform an appropriate MRI can be found.

 

There are several criteria that should be applied to an MRI center to determine if it is a quality operation.

 

For example, if a center says it can perform a breast MRI, it should also have the capability to do an MRI guided breast biopsy if a suspicious lesion is found.  If the center doesn’t have that capability, it is probably in your interest to go elsewhere.

 

Dr. Smith, in his editorial, emphasizes the need for standardized quality programs to assure women that the center performing their MRI meets certain recognized standards, much as was the case a decade ago in setting standards for mammography to assure at least a baseline level of quality for that procedure as well.

 

The New England Journal article focuses on one very important high risk group of women who should consider an MRI for the early detection of breast cancer.

 

There are many other women at high risk who also could benefit from adding an MRI to their breast cancer screening program—in addition to a mammogram and clinical breast examination once annually.

 

Until now, however, there have not been any clear-cut guidelines as to which women at high risk are likely to benefit from the addition of a breast MRI once a year.

 

Simultaneously with the release of the New England Journal article, my colleagues and volunteers from the American Cancer Society published another article which outlined specific recommendations for women and their physicians as to when an MRI should be performed for screening, in addition to an annual screening mammogram.

 

This report, in the current issue of CA: A Journal for Clinicians, updates our prior recommendations from 2003, when the evidence about MRI screening in breast cancer was not sufficient to make specific recommendations.

 

The expert panel who wrote the article now makes very specific recommendations for MRI screening for breast cancer.

 

(The recommendations are too detailed to provide in this blog, but you can find them by going to the actual article.)

 

Among the groups included where screening is recommended are:

 

--Women who are BRCA positive;

 

--The first degree relatives (that is, mother, sister, daughter) of someone who is known to be BRCA positive, but the woman declines to get the test, and

 

--Women whose lifetime risk of developing breast cancer is 25% or greater, as measured by one of the available breast cancer risk models.  These models include the Gail, Claus and Tyrer-Cusick models, as described in the article.

 

The expert panel also recommended that women who had radiation therapy to the chest as part of cancer treatment (in particular, Hodgkin’s disease patients) when they were between ages 10 and 30 should have an MRI as part of their breast cancer screening program.

 

There are some situations where there is not enough evidence to recommend for or against the use of MRI as part of a screening program. 

 

These include women where the models mentioned above show a 15-20% lifetime risk of getting breast cancer, where the woman has lobular carcinoma in situ or atypical lobular hyperplasia, or if she has a history of atypical ductal hyperplasia.

 

Also of note is that the panel was “indeterminate” in making a recommendation regarding women who have dense breasts on mammography, or in women who themselves had a personal history of breast cancer including DCIS (in contrast to the prior article, where MRI was studied ONLY at the time of primary diagnosis).

 

And, perhaps of considerable importance, is the recommendation that women who have a lifetime risk of breast cancer that is less than 15% should not have MRI included in their breast screening program.

 

There is obviously much more to this report than can be listed in this blog.  For example, there is a discussion whether the MRI and mammogram should be done at the same time, or staggered every six months (mammogram on day 1, MRI in 6 months, mammogram in one year, and so on).

 

In addition, there is a very detailed discussion about MRI quality and the fact that if the MRI is not done right by someone who has considerable experience doing breast MRI, it should not be done at all.

 

This discussion has very practical implications.

 

A couple of weeks ago I had a conversation with a friend whose young wife had just been diagnosed with breast cancer.   One of the topics we reviewed was whether or not she should have an MRI of the breast not involved with the cancer to see if another tumor was present in that breast as well.

 

This past week, during a casual conversation with another friend, the topic of breast cancer risk in his wife, who was a Hodgkin’s disease survivor, came up.  Again, the question was raised whether or not she should have an MRI as part of her routine surveillance for the early detection of breast cancer.

 

Both of these discussions highlighted what we know and what we do not know about the use of MRI in the early detection and screening for breast cancer.

 

Until now, we simply have not had good evidence upon which we could make reasonable recommendations to women with these types of histories, and many other women who had similar questions about the use of MRI as a screening tool for breast cancer.

 

Now, with the evidence at hand, I can tell my friend that his wife with recently diagnosed breast cancer that she should have an MRI of the opposite breast before she undergoes her breast cancer surgery (she did, and it was negative).

 

And my other friend’s wife—who had Hodgkin’s Disease and is now in her 50’s—should also consider adding an MRI to her annual screening.

 

We still don’t have all of the answers, and both articles point out the issues that remain to be clarified.

 

But we are much further along in developing the evidence that will guide us in making the best recommendations we can to women and their doctors on how to use an important imaging technique for the right women at the right time, when it counts the most in reducing the potential burden and suffering from breast cancer.

 

Tony Snow: The Impact Of Recurrent Colon Cancer

by Dr. Len March 27, 2007

This has been a week notable for people in the public eye who have had a recurrence of cancer.

 

Last week, as widely reported, Elizabeth Edwards was diagnosed with recurrent breast cancer.

 

No sooner had that announcement swept through the media than Tony Snow, the President’s press secretary, announced that tests revealed he also may have a recurrence of his recently diagnosed and treated colon cancer.

 

The information released Friday by Mr. Snow indicated that follow-up studies had shown a small area of possible cancer recurrence in his abdomen. 

 

Through an abundance of aggressive caution, as he put it, he announced that he was going to undergo exploratory abdominal surgery on Monday to take a closer look at whether or not this in fact was a recurrence.

 

This morning we heard that in fact his cancer recurred and involved his liver. 

 

I decided to wait until this evening to find out if more information was forthcoming.  In fact, that is about all that we know.

 

I made a comment last week about Ms. Edwards that what we know is what we know, and we don’t know everything.

 

That is the same situation that exists with Mr. Snow.  We simply have little information other than what has been provided. 

 

Doctors who treat patients with cancer are aware that there is more we could hear about both of these cases.

 

But that begs the question in my mind, because I’m not certain that it would be appropriate or reasonable to expect either of these folks to release all of the details of their cases.

 

Colon cancer is common in this country, and is the second most common cause of cancer deaths (it is third for both men and women, but combined it is number two after lung cancer).

 

We know that we could do more to save lives from colorectal cancer if people only did what we know works: begin screening for colorectal cancer at the appropriate time which, for people at average risk, is age 50.

 

But Mr. Snow is in a special circumstance.  He is 51, and he had inflammatory bowel disease according to some reports.  We know he previously had surgery and chemotherapy.  He has been forthcoming in the past about the fact he had the disease, and giving of his time and effort to speak to people about his experience.

 

Now the cancer has recurred and once again the speculation has begun in the media.

 

We know the situation is not good.  Mr. Snow knows the situation is not good.

 

There are several treatment options that are going to be considered for him, including chemotherapy, additional surgery, tumor embolization and possibly using radiofrequencies to try and ablate the cancer among other options.

 

His treatment is going to be determined by his physicians based on their findings at the time of surgery and by the results of tests which will show the extent of the recurrence.

 

We can speculate ad nauseum, but ultimately Mr. Snow is an individual who is going to have access to the best medical care available.  His treatment and the subsequent course of his disease are both unknown at this moment, and the latter is going to be unknown for some time as he proceeds through the various phases of his treatment.

 

Beyond commenting that each individual is unique with respect to their outcomes in a situation like this, I can also say with some confidence that the course of recurrent colon cancer today is much different than it was 30 years ago.

 

New drugs—many of which were not available even a decade or even a couple of years ago—have contributed to substantial progress in the treatment of patients with recurrent colon cancer.

 

New techniques—and a better understanding of older ones, such as the value of surgically removing metastatic disease in the liver when that is possible—have resulted in long term remissions and even apparent cures in patients with colorectal cancer.

 

All of these factors account for the optimism expressed in the various news stories I had a chance to see today about Mr. Snow’s outlook.

 

At the same time, I feel compelled to say that we need to respect and understand his need for some personal space to deal with this illness, its treatment and its prognosis.

 

I know that sounds naive.   After all, we live in a media-dominated world, and this gentleman is right up there in terms of media exposure.

 

But this is not a situation where a celebrity decides to cut off her hair or go and get a tattoo.

 

Both Ms. Edwards and Mr. Snow are going through intensely personal experiences. 

 

Depending on the information gathered through the various surgeries and tests and the recommendations of their doctors, they may be going through very intensive treatment for the foreseeable future.  They are certainly going to face significant uncertainties as they go about living their lives.

 

No one—not me, not anyone—can predict the outcome of their treatment or the course of their diseases.

 

All of us offer our prayers to them in their time of need, as we do for every person and every family member, friend, and colleague of anyone who has been so afflicted.

 

I was struck last week about how intensely interested the media was in coming up with a number regarding Ms. Edwards’ chances of survival.  I personally felt compelled to be cautious, and professionally I was comfortable with being modestly optimistic (as were many of my colleagues who commented in the public record).

 

However, during one interview, I was talking with a reporter and made a similar observation that no one—not even the American Cancer Society—could reasonably opine as to Ms. Edwards’s outlook, and suggested that the media should respect this uncertainty. 

 

The slight chuckle at the other end of the phone let me know that the speculation game was on, and nothing I said was going to influence that pursuit.  (I will say that, in the end, much of the initial speculation was adjusted and became more consistent with what we reasonably know and can offer in such a situation.)

 

The occasion of Mr. Snow’s diagnosis is no different.  I still hold the same opinions, and would make the same plea.

 

These two politically active individuals have accepted the limelight as part of the process of being who they are and where they are.  They know they live in the public spotlight, and they have both commendably shared with us what has to be one of the most personally intense events of their lives.

 

They are both facing the stark reality that they have incurable diseases.  They are both facing their treatment and their prognoses with candor and public bravery.   They both must be struggling with the realization that they and the people who love them and admire them are going to go through an intense and emotional period of time.

 

Both Elizabeth Edwards and Tony Snow represent more than their individual lives. 

 

They have given visibility to the situations faced by thousands of patients with cancer in this country. 

 

Those patients, their families, friends and colleagues know the personal anguish that has engulfed both of these public figures. 

 

Those patients understand what it means to hear that a cancer once hoped to be cured has now returned, and that treatment can only contain—but not cure—their disease.

 

Both Ms. Edwards and Mr. Snow also reflect what many of us who treat patients with cancer have known for many years: Our patients are very special people. 

 

Many of them face their disease and their lives with bravery and fortitude, knowing that the treatments may work, or they may not. 

 

Somehow, these special people find strength within themselves that they did not know they had.  They are able to reach within themselves to fight on, to comfort those around them, and realize they need to make the maximum personal effort.

 

I don’t know how they do it, but I admire them with all my heart.

 

When Elizabeth Edwards and Tony Snow let people know they are moving forward, that they are going to continue their lives to the best of their abilities, and that they understand what they are about to face, they represent the best that is in all of us, and they represent those among us who fight this battle every day.

 

They are not alone, and our prayer is that no patient who is fighting cancer is alone. 

 

They share, and we share.  We are all better for having the opportunity, no matter how difficult the circumstance.

Elizabeth Edwards: Information About Statistics

by Dr. Len March 22, 2007

There is some significant misinterpretation by the media with respect to the survival data for women with stage IV breast cancer.

In light of the importance of this to Senator and Ms. Edwards, as well as everyone interested in her story, I want to make certain that you understand that the numbers being quoted as coming from the American Cancer Society do not relate to Ms. Edwards situation.

We publish a monograph every year called Cancer Facts and Figures. In that booklet, we provide a wealth of information regarding cancer incidence, mortality, prevention and early detection along with a considerable number of statistics  related to cancer in the United States.

In that booklet there is a table titled "Five-Year Relative Survival Rates by Stage at Diagnosis, 1996-2002."

In that table, the five year survival data for breast cancer is listed as:

All Stages:      88.5%

Local:              98.1%

Regional:          83.1%

Distant:            26.0%

Local disease is confined to the breast, regional disease includes the breast and adjacent lymph nodes, and distant disease includes the spread of breast cancer to other organs, including the bone.

This data is obtained from a comprehensive cancer statistical database called SEER, which is published by the National Cancer Insitute in conjunction with other partners.

What the media has stated incorrectly, based on this data, is that Ms. Edwards has a 26% chance of living five years.

The survival statistics on the American Cancer Society web site and in Cancer Facts & Figures apply to a woman who presents initially with a stage IV breast cancer, not a woman who has a recurrence after primary treatment.

The outlook for a woman who walks into the doctor's office with metastatic disease is significantly worse than for a woman, like Mrs Edwards, who presents initially with disease confined to the breast and adjacent lymph nodes.

The survival statistic for patients who present with Stage IV disease has no meaning in Ms. Edwards' case, and should not be interpreted as a suggestion of her survival chances.

Although we keep excellent national statistics on cancer incidence, mortality and stage at presentation in this country broken down by age, gender, ethnicity and region, we do not have a national, validated database which provides information on the probability of survival when the cancer recurs after primary treatment.

As I noted in my blog posting earlier today, there is too much individual variability with respect to treatment and other factors to make any meaningful estimate regarding a particular woman's survival after a recurrence has been diagnosed.

Although some experts and centers may be willing to provide that information based on their experience, we simply do not have data of a national scope that can be reasonably and appropriately applied to a particular woman such as Ms. Edwards.

One other fortunate and realistic consideration is that we are in the midst of a revolution in the treatment of metastatic breast cancer.  No one today can predict the impact of the new developments in the treatment of recurrent breast cancer over the next five or ten years.

So here is my bottom line:

The Edwards' have made a decision to share her illness with the public.  We don't know all of the facts yet, in no small part because not all of the information is available as of today.

Let's respect them for what they have done, and avoid the speculation.  Let's be certain that we say what we know, and be cautious about what we don't know, especially when it comes to prognosis.

I doubt there is anyone out there who would want to be treated any differently.

Elizabeth Edwards: What We Know And What We Don't

by Dr. Len March 22, 2007

Since arriving in the office this morning and learning of Elizabeth Edwards’ breast cancer recurrence, I have been trying to piece together the story of what happened and what the impact may be on Senator Edwards’ presidential campaign.

 

I have been fascinated (if that is the correct word) at the guessing games that have been going on both about her health and his campaign.

 

Now that I have had a chance to see the news conference, it is clear that all of this speculation about the Senator suspending his campaign was way off the mark.

 

In the same vein, I think it is important from a medical point of view that we bring a sense of rational discussion to the situation surrounding Ms. Edwards’ disease and her potential treatment.

 

A high profile person in the public spotlight always has to deal with the issues of health, especially when there are serious illnesses involved.  I have learned from experience that trying to guess about a particular person’s situation is a dangerous game, and frequently incorrect.

 

One also learns to respect the privacy of celebrities when it comes to matters of their health.  Should they wish to share information, fine.  But when they don’t, it is equally important to take note of that decision and act accordingly.

 

The Edwards’ were very open today about what is transpiring in their lives.  There is still much that is unknown, and much that is unknowable. 

 

What is clear, both from their comments and the comments of her physician, is that they have apparently provided us with all the information that they know, and perhaps even more than some of us would have expected.

 

Let’s take a look at what we do know.

 

Elizabeth Edwards is 57 years old.  She had breast cancer diagnosed in 2004 during the presidential campaign.  I have heard that she had chemotherapy and radiation therapy for her cancer, but we don’t know the actual type of chemotherapy that she received nor do we know the characteristics of her breast cancer. 

 

I do not know if Ms. Edwards received any additional adjuvant therapy beyond the primary treatment course.

 

At today’s news conference, as it was initially presented, Ms. Edwards indicated that she developed pain on her left side after an apparent rib fracture following a hug from her husband (some hug!!!).  That in turn led to a bone scan, which showed a lesion on the right side which was subsequently biopsied.

 

I have been told that her doctor has now said that there may be other lesions present, so we really don’t know at this time what the extent of the disease is.   What we can say is that it has recurred, and at the least has metastasized to the one area of bone.

 

And, more importantly, we don’t know yet what treatment will be prescribed. 

 

What the doctors are going to do (in fact, are already doing) is perform a number of studies to get an idea of where the disease has spread.  They have already taken a biopsy, and they are going to do additional tests on that biopsy to get a sense of the characteristics of the recurrent disease.

 

Once that analysis is done, they will make recommendations regarding therapy.  However, based on the comments by Ms. Edwards, it would appear that the treatment would have only modest side effects.  That suggests a treatment other than intensive chemotherapy.

 

But, with these comments I find myself falling into the same speculative trap that I warned about.

 

Decisions about treating recurrent breast cancer are complex, and it takes time to complete the studies, obtain the results of the biopsies, and analyze the tissue.

 

What does impress me is the openness and the honesty the Edwards family displayed today in talking with the media.

 

This is an intensely personal situation.  It is one that is experienced by thousands upon thousands of cancer patients every year in this country.  It is not unlike what many folks have to go through in their daily lives.  The difference is that this man is running for President of the United States.

 

Ms. Edwards looks well and feels well, and that in my professional opinion is a very important observation.   In fact, given current guidelines, we do not do routine bone scans to look for recurrence at the earliest possible moment.  Instead, we usually let a woman’s symptoms and sense of well-being guide us into looking for recurrent disease. 

 

In Ms. Edwards’ circumstance, the lesion on the bone where the cancer was found was asymptomatic.  Under usual circumstances, it may not have been found for some time.

 

The Edwards’ have already crossed the biggest hurdle of this discussion, and that was their comment that her disease is treatable, but not curable.

 

We do not know as I write this what the future holds for Ms. Edwards.  I have seen patients do very well under these circumstances, and I have seen patients not do as well.

 

What I do know is that I have had many patients with more serious and more extensive recurrent breast cancer who have done well for extended periods—and that was well before we had access to many of the more effective drugs and targeted therapies that are available today.

 

I will not provide a statistic as to Ms. Edwards' prognosis.  I believe that is inappropriate in this type of circumstance, for all the reasons I have mentioned above.  Each woman with breast cancer, at the time of recurrence, is an individual.  The extent of their disease, the characteristics of their disease, their treatment options and many other considerations must be considered in making such a prediction.

 

You may see survival statistics quoted in various reports, and these statistics may be attributed to the American Cancer Society.  However, those statistics refer to the stage of disease at the time of initial diagnosis, which for Ms. Edwards was in 2004.  They do not apply to recurrent breast cancer, which for Ms. Edwards occurred in 2007.

 

I admire the Edwards and their physician for being so forthcoming.  Had they not been, I would not have provided as much commentary as I have here. They have made this task much easier, and more honest than it would have been otherwise.

 

We must remember that Ms. Edwards is one woman—like so many women—who has a disease that may take one of many paths.  The Edwards appear to understand that, as reflected in their statements, their experience and their demeanor.  This is not the first time they have had to deal with serious personal life-altering issues.

 

Our hopes and prayers go out to Ms. Edwards and her family, as they do to all the women and families who have faced this disease with similar strength, love and support.

 

What we saw on camera today was exemplary, but it is no less an example than the one experienced in many homes in this country every day.

 

This is one woman, who represents many.  We should never forget that as we follow Ms. Edwards through the upcoming campaign and her personal battle to fight this disease. 

Filed Under:

Breast Cancer | Treatment

Aranesp & Procrit: What Is The Danger?

by Dr. Len March 22, 2007

It started as a report in a cancer professionals’ “insider” newsletter.  It is becoming one of the most important cancer stories of the past several years.

 

It is a story that has already affected how patients with cancer are treated, and is destined to shed light on how drug companies reveal information about the side effects of their drugs, how insurers and Medicare make their decisions about paying for drugs, and perhaps how doctors are reimbursed for their treatments.

 

It is about to enter the national spotlight through a Congressional inquiry.

 

The story is about a class of drugs called erythropoiesis-stimulating agents, which increase red blood cells in our bodies. 

 

You are most likely familiar with them through their trade names Procrit and Aranesp.  The generic names of these drugs are epoetin alfa (Procrit) and darbepoetin alfa (Aranesp).  They are commonly used in cancer treatment to reverse the anemia that results from chemotherapy and radiation therapy, as well as the chronic anemia that is related to the cancer itself.

 

If you watch TV regularly, it would have been difficult to miss the direct to consumer advertising over the past couple of years that touted the benefits of these drugs, especially for patients undergoing treatment for cancer.

 

This all started on February 2, 2007 when “The Cancer Letter” published a front page story headlined “Study Finds More Deaths On Aranesp Arm In Cancer Anemia Study, No Benefit Seen.”

 

The story reviews an FDA announcement from January 27, 2007 which indicated that in a clinical trial Aranesp, manufactured by Amgen, increased the risk of death when used to elevate red blood cell counts in patients with cancer if it was used at a time when the patients were not receiving active treatment with radiation or chemotherapy.  This condition is called the “anemia of cancer.”  (It is important to note that this discussion does not apply to the use of these drugs when used to boost red blood cell counts in patients who are undergoing active radiation therapy and/or chemotherapy for their cancer.)

 

As the article reported, doctors had difficulty putting the announcement into proper clinical context because very little information about the actual study itself was made available in the FDA announcement or elsewhere.  In fact, the writer had to go to another website to find a description of the clinical trial.  This description had been posted as part of a public repository of clinical trials.  But this site provides no information on the results of those trials.

 

Here is the statement in The Cancer Letter story that got my attention:

 

“If the findings of the recently reported study hold up, more than one in 10 Americans getting Aranesp without chemotherapy has no chance of benefiting from the agent and could be harmed or killed by it, experts say.”

 

According to the article, the company was slow to release the information, saying that the study was designed to measure a reduction in the need for red blood cell transfusions and not to look at the actual causes of death of the patients in the study. 

 

As a result, doctors weren’t able to determine whether or not these deaths were more likely or less likely related to the use of the drug as opposed to other causes, such as the underlying cancer.

 

This was no trivial matter.  The article cites estimates that up to 12% of the use of these drugs in the United States was for this particular indication.  That meant that many patients were in fact at risk, and neither they nor their doctors knew about it.

 

It was reasonably clear from the analysis in the Cancer Letter story that there was a considerable “off label” use of Aranesp for the cancer anemia indication, and the quotes from company officials essentially said that it would be up to doctors to decide whether or not they wanted to use this drug under these circumstances, the risk of death notwithstanding.

 

This high usage of erythropoietin agents for an “off label” indication that had not been supported by clinical trials did not happen in a vacuum. 

 

Various well-established and respected professional organizations provided guidelines to use these medications in the treatment of cancer related (not treatment related) anemia at various red blood cell levels.  This was a widely used and widely accepted indication in the oncology community, even though the FDA had never directly approved the use of these drugs for this particular indication.

 

The companies kept the names of the drugs well in the public view through direct to consumer advertising, although that advertising did conform with FDA guidelines.

 

The report in The Cancer Letter set off a series of events which continues to increase in intensity and concern.  This issue has clearly caught the attention of the cancer community, as well as others—including Congress.

 

A Medicare carrier (Noridian) indicated that they would no longer cover the use of Aranesp in cancer patients with chronic anemia that is not related to their treatment.

 

(A little known fact is that many decisions to cover or not cover certain procedures or drugs in the Medicare program are carried out by Medicare carriers that are located in different parts of the country, and not by Medicare on a national basis.  This process is called the Local Medical Review Program, or LRMP.  For many situations, such as coverage with these types of drugs, there is no national coverage policy that is applied uniformly across the country by Medicare.)

 

The FDA, in collaboration with the manufacturers of these drugs, has moved to alert doctors and patients to the increased risks associated with this treatment for these types of cancer patients.

 

On the FDA website there is now a statement regarding the possible hazards of the off-label use of erythropoietin drugs in patients with anemia related to their cancer.  The FDA now cautions that the use of these drugs only to treat anemia of cancer is not appropriate.

 

Here is a portion of the FDA statement: 

For cancer patients:

  • Use of an ESA in anemic cancer patients who are not on chemotherapy offered no benefit and may shorten the time to death.
  • ESAs are not FDA approved to treat anemia in cancer patients not receiving chemotherapy
  • There is a potential risk of shortening the time to tumor progression or disease-free survival
  • ESAs are administered only to avoid red blood cell transfusions in cancer patients.  ESAs do not improve the outcome of cancer treatment and do not alleviate fatigue or increase energy.

In a letter from Ortho Biotech dated March 12, 2007, the manufacturer of Procrit announced the new FDA safety information, and the addition of what is called a “black box warning” to the prescribing information for their drug.  A black box warning is the highest level of warning provided by the FDA and drug manufacturers to warn physicians and patients of very serious risks regarding the use of that particular drug.

 

The letter continues, “The results of the following studies have not been previously communicated to physicians in an Amgen or Ortho Biotech Dear Health Care Professional Letter.” 

 

The letter goes on to outline the poorer outcomes and increased risk of death in patients treated with head and neck and lung cancer if treated with these medications.  In one study, the survival was less than half for patients treated with the drug, compared to patients who did not receive the drug.

 

The letter concludes with a comment that the FDA is going to have an advisory drug panel meeting on May 10, 2007 to review the safety and effectiveness of these medicines.

 

In the current issue of the Journal of Clinical Oncology, there is a study that reports on the use of erythropoietin in patients with non-small cell lung cancer who could not receive curative treatment.

 

The study concludes, “An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC (non-small cell lung cancer) treated with epoetin alfa. Although infrequent, other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely.”

 

An editorial which accompanied this study acknowledged the report in The Cancer Letter. 

 

The author of the editorial stated, “The study (as reported in The Cancer Letter) brings forth common themes; the study was evaluating erythropoietin treatment outside standard guidelines, safety concerns have been raised, and further scrutiny is needed.”

 

The editorial goes on, “…I would draw the reader’s attention to the importance of following practice guidelines in the management of patients with cancer related anemia, with respect to the target hemoglobin level of 12 g/dl.  Meanwhile, preclinical and clinical investigation has been enhanced by this controversy, which should help us in our common goal to use this high profile/high scrutiny paradigm to achieve the highest benefit possible for our patients.”

 

The American Society of Clinical Oncology, which publishes the Journal of Clinical Oncology, has not updated its guidelines regarding the use of these drugs in the treatment of cancer related anemia  It does refer the reader to the FDA website for more information.

 

The National Comprehensive Cancer Network (another guidelines-setting group whose opinions I highly value) acknowledges the issues that arose from the trial reported by The Cancer Letter in their current guidelines for the use of these agents in the treatment of cancer patients. 

 

They conclude, “Until new research evidence changes current benefit: risk estimates, physicians should be advised not to administer erythropoietin to patients similar to those enrolled in the Amgen trial.” 

 

According to information from Amgen, that would be the following: Patients with active cancer not receiving or not expected to receive chemotherapy or radiation therapy. (Note: I cannot provide a direct link to their letter since it is on an area of their website restricted to health care professionals.)

 

As you can tell, that description encompasses a lot of people who have cancer.  60% of the patients on this trial had stage IV disease.

 

On March 14th, the Centers for Medicare and Medicaid Services (CMS) posted a notice on their website that they were initiating a public comment period regarding the use of these drugs for non-kidney related indications.

 

(That includes cancer.  What I haven’t begun to get into in this blog is the other major controversy that is part of this total package, and that is the use of erythropoietin drugs in patients with chronic kidney disease, including those on dialysis.  The drug that is used in these patients is called Epogen, but it is the same class of drugs as those used in cancer patients.)

 

What this means is that CMS has now decided it is going to make a national coverage determination on whether it will pay for these drugs in this situation, as opposed to the LMRP approach I discussed previously in this posting.

 

This decision is of significance beyond the safety issues. 

 

Erythropoietin is the most expensive drug—by far—used in cancer treatment in the Medicare population.  And, physicians who administer the drug receive payment for their services, which is likely not inconsequential (there are no immediately available data that I am aware of that would quantify the administration costs—exclusive of the drug costs—for administering these drugs in doctors’ offices).

 

One insurance company representative stated at a conference I attended recently that their charges for the administration of erythropoietin decreased by 44% in one pilot study when they asked the doctors to provide a red blood cell count along with their bill for administering the drug.  

 

The clear implication was that physicians were giving this drug to many patients whose red blood cell counts were otherwise within acceptable (or at least reasonable) limits.

 

Finally, not to be outdone, letters went out yesterday from the House of Representatives Committee on Energy and Commerce to the CEOs of both companies that manufacture these drugs.

 

The letters state, “…We note with increasing alarm reports indicating that Erythropoiesis-Stimulating Agents (ESAs), commonly known as EPO products, when used at higher than recommended doses, appear to cause increases in blood clots, seem to grow tumors and are associated with significantly higher mortality rates than placebo.”

 

The letter continues, “There has been, however, no indication that (name of company) will forego its direct to consumer advertising which drives off-label uses of prescription drugs.  Nor has there been any public announcement of a cessation of financial incentives to physicians to increase the prescription of (name of erythropoietin drug) to their patients.

 

The letters go on to say that the Committee requests the companies to cease their direct to consumer advertising and physician incentives until the FDA has had time to study the issue.  The letters conclude with a series of questions relating to who knew what and when and what they did about it.

 

I would caution that the story is not complete at this time.   There is more to learn, and more to discuss.

 

Knowledgeable professionals are guarding their reactions, awaiting further data and guidance. 

 

Undoubtedly, patients are confused and probably frightened about what they should be doing if they are taking these drugs.  I suspect their doctors are confused as well as to what they should be recommending to their patients with cancer related anemia.

 

It is clear that the FDA, Medicare, and now Congress are all going to be making some decisions about what happened here and how important this really is. The professional organizations that we look to for guidance in these matters will also be monitoring this situation very carefully, so they can adjust their treatment guidelines as appropriate.

 

I suspect that insurers are going to tighten their payment policies when it comes to paying for this treatment for this indication.

 

In the meantime, what should you do?  On the one hand, if you are a cancer patient who is anemic and not receiving current treatment with chemotherapy and/or radiation therapy, you have the FDA saying that you should not be taking these drugs.

 

Other experts are not so certain.

 

Ultimately, any determination about whether or not you should be taking Procrit or Aranesp rests on a discussion with your oncologist about your specific situation, and a mutual decision about what you should do about your treatment.  No one knows you better than your doctor, and you should work together to become fully informed and make the best educated decision that is right for you.

 

We still have much to learn about what happened here, and even more importantly what the implications are for our patients and their medical care.

 

What concerns me is that there remains the possibility this picture will not be a pretty one once all the investigating is finished and the dust has settled.

 

And, it would be a very serious matter indeed if patients were put at risk because of someone’s reluctance to make everyone aware of these serious side-effects as soon as they knew there was a problem with these treatments.

 

As I have said before, stay tuned.

 

Filed Under:

Cancer Care | Medications | Treatment

Is Tykerb A Major Advance, A Step Forward Or Both?

by Dr. Len March 13, 2007

The media is abuzz today about the approval of Tykerb (also known by its generic name “lapatinib”) by the Food and Drug Administration (FDA).

 

Reporters are asking about how important this new targeted therapy really is and what will be its impact on the treatment of women with breast cancer.

 

The answers we provide to these questions today are fairly straightforward.  But the impact over time is a bit more uncertain.

 

Breast cancer is not one single disease.

 

When breast cancer is diagnosed, the doctors examine the cancer specimen for several different markers which give us clues as to how the cancer will behave, and what treatments may be helpful in preventing its recurrence.  These tests also provide clues as to what treatments may be most effective if the breast cancer relapses.

 

For many years, we have measured hormone receptors (estrogen and progesterone) in the breast cancer tissue, and more recently have added another genetic marker called HER2.

 

When this HER2 marker is present in the cancer tissue (as is the case in approximately 20% of the estimated 178,480 invasive breast cancers that will be diagnosed in women in the United States in 2007), it signals a cancer that is usually more aggressive than the typical breast cancer.  It also usually occurs in a younger population.

 

Herceptin (also known by its generic name trastuzumab) is a drug that targeted this abnormality in breast cancer tissue.  When it was first approved by the FDA in 1998, it represented a significant step forward in the treatment of advanced breast cancer in women who had this particular genetic marker. 

 

Trastuzumab improved response rates and lengthened survivals for many women who found themselves in a grim situation. It wasn’t a cure, but it was a major step forward.  It represented not only an effective cancer therapy but also proof that targeted therapies could be very helpful in the treatment of a variety of cancers.  (The American Cancer Society has taken great pride in the fact that it provided financial support early in the career of the scientist who went on to develop this drug.)

 

More recently, in 2005, research was presented at a major cancer meeting and then published in the New England Journal of Medicine that trastuzumab was very effective when used in the adjuvant treatment of breast cancer when women were HER2 positive. 

 

Adjuvant treatment is used after the primary treatment of breast cancer, which usually includes surgery and radiation therapy. 

 

These studies demonstrated that trastuzumab, as part of a regimen of adjuvant chemotherapy, decreased recurrences and decreased deaths in women with breast cancer who were HER2 positive at the time of initial diagnosis.

 

The impact of these reports was dramatic.  They literally changed the standard of care for breast cancer treatment overnight in the United States and elsewhere.

 

But for those women who could not tolerate trastuzumab, or whose disease progressed after taking this intravenous drug, there have been few effective options, and certainly no new targeted therapies that honed in on the particular genetic marker in question.

 

That’s where lapatinib fits in, and that is why there is so much excitement.

 

Lapatinib is a drug that is taken by mouth, and works in the same women who are candidates for trastuzumab—namely, those who are HER2 positive.

 

In a study and editorial reported in the New England Journal of Medicine in December of 2006, researchers reported the results of a clinical trial where women with breast cancer who were HER2 positive and had failed treatment with intensive chemotherapy and trastuzumab were randomly assigned to be treated either with another chemotherapy drug as a single agent, or with the same chemotherapy drug with the addition of lapatinib.

 

The chemotherapy drug was capecetibine, which is another oral drug and similar to an old intravenous chemotherapy standby called 5-FU (or 5-fluorouracil).

 

The results in this study of 324 women showed that, in the women who received capecetibine with lapatinib, the time it took for the cancer to resume its advance after starting the new treatment was 8.4 months on average.  For the women who received just the chemotherapy without lapatinib, the time to disease progression was 4.4 months.

 

In other words, the women who received the additional new targeted therapy had their disease remain at least stable for about twice as long when compared to the women who received only chemotherapy.

 

Also of interest was the observation that women treated with lapatinib had fewer recurrences in the brain compared to the chemotherapy-alone group, however this observation did not meet the test for statistical significance.  This means that this could have happened by chance alone.

 

Unfortunately--and this is an important observation--the overall survival for both groups, whether treated with chemotherapy alone or chemotherapy with the addition of the targeted therapy, was equivalent.

 

Side effects with the addition of lapatinib to the chemotherapy were modest, with diarrhea, dyspepsia and rash seen more often in the women treated with the new drug.  No one had to stop treatment with lapatinib because of heart problems, which has been a concern with trastuzumab.

 

So what does this mean?  Is this really a great new breakthrough in the treatment of breast cancer?  Is this drug going to replace trastuzumab in the treatment of women with HER2 positive breast cancer?  Where does it fit today in the treatment of breast cancer, and what are lapatinib’s future prospects?

 

The answers to these questions as of today are fairly straightforward.  Interestingly, the answers may be more difficult as time goes on and we learn more about the benefits, risks and effectiveness of both lapatinib and trastuzumab.

 

First, is this a great breakthrough?

 

Yes, and no.

 

Yes, it is a significant step forward because it once again demonstrates the promise of targeted therapies, where we take our understanding of how cancer cells work and apply that knowledge to new drug development.

 

Yes, because we now have a new drug that offers promise and hope to women who have a more aggressive form of breast cancer, where until very recently we had little to offer.  Now, we have two drugs that are effective in treating this particular form of the disease.

 

Will this change the way we treat breast cancer patients today?  

 

For the most part, no. Women who have surgery or recurrence of their disease will still be tested for HER2.  If they are positive for the marker, and are candidates for trastuzumab, they will still most likely (and appropriately) receive trastuzumab as their first-line choice of treatment. 

 

I do not see lapatinib being used today in the adjuvant therapy of breast cancer, except perhaps in those women who cannot tolerate trastuzumab.

 

We need to remember that lapatinib was tested only in women with advanced and progressing breast cancer where other treatments—including chemotherapy and trastuzumab—had been tried and failed.  So, these were the types of situations where any response was welcome news, even if it didn’t prolong survival.

 

Over time, I have no doubt that studies will be done to look at lapatinib’s effectiveness earlier in the treatment of breast cancer, such as at the time of first recurrence and possibly even in a head-to-head comparison with trastuzumab.  There may even come a time when both drugs will be used together to find out if the combination is more effective than either drug alone.

 

But for now, lapatinib is going to be used to treat women with breast cancer where trastuzumab is no longer effective, or where a woman cannot tolerate trastuzumab.

 

There have also been several preliminary reports on the use of lapatinib in the treatment of other cancers.  Some of those reports have been promising and others less so.   But it is too early to know which other cancers—if any—are going to respond to this new drug.

 

Advances in the treatment of cancer rarely come in big, giant steps.  They come in a series of smaller advances that, when grouped together over time, result in significant progress.

 

That has been the case with the treatment of colorectal cancer and breast cancer, and this  announcement regarding the approval of lapatinib will have a similar impact.

 

But that does not diminish the fact that we are in the midst of a revolution where we are rapidly developing and using targeted therapies for targeted cancers.

 

The era of truly personalized medicine in the treatment of cancer is just beginning.

 

Our research efforts of the past three to four decades are making the significant advances of today not only possible, but very real in terms of saving lives and improving the quality of life and outlook for people with cancer.

 

As I have said before, and will repeat many times in the future, these are very exciting times in the oncology community.

 

Lapatinib is but one example of this revolution in progress.  We are fortunate to be able to take advantage of the investments we have made in the past, and we look forward to continue making those investments for our future.

 

 

Should We Screen For Lung Cancer, Or Not?

by Dr. Len March 06, 2007

It wasn’t but a couple of months ago that an article was published in the New England Journal of Medicine that claimed spiral CT scans for the early detection of lung cancer could significantly decrease deaths from this disease.

 

Now, a study reported in this week’s Journal of the American Medical Association says that there is no evidence screening for lung cancer with chest CT scans does anything to reduce deaths from lung cancer.  In fact, this study claims, it substantially increases the number of cancers detected, the number of surgeries performed, and exposes patients to significant risks for no net gain in survival.

 

Why all the confusion?

 

This past October, as discussed on this blog, the New England Journal study indicated spiral CT scans were in fact able to reduce deaths from lung cancer by finding nodules early.  The survival of the patients where lung cancers were found had been outstanding, according to the report—much better than had ever been seen previously.

 

Although hailed by many experts and advocates as the answer to our prayers to reduce the suffering and loss of life from this terrible disease, there were those at the time who felt the study did not provide sufficient evidence to recommend universally that current and former smokers rush out to get screened.

 

Left unanswered in that study was the possibility that in fact the investigators were diagnosing lung cancers that never would have made a difference to the patient.

 

That’s hard to believe, but it is a real concern.

 

This week’s JAMA report adds some credibility to that argument, claiming that the evidence does not support the conclusion that lung cancer screening with CT scans reduces deaths from lung cancer.

 

In this study, the authors reported on the results of spiral CT scanning performed on over 3200 patients screened at three academic medical centers, two in the United States and one in Italy.

 

They carefully examined the number of lung cancers diagnosed, the number of surgeries performed, the stage of the lung cancer at diagnosis, and the rates of death from lung cancer in the patients who were screened.  They then compared these rates with a set of data based on previous lung cancer trials to find out how many surgeries and deaths were observed compared to how many were expected.

 

There results were astonishing, to say the least.

 

In patients screened with spiral CT scans for the early detection of lung cancer, over 3 times more lung cancers were diagnosed than would have been expected.

 

The number of surgeries to remove a lung cancer was ten times (yes, ten times) greater than what was expected.

 

Even with all of those lung cancers that were diagnosed and all those surgeries that were performed, there was no evidence that fewer people were diagnosed with advanced lung cancers than were expected. 

 

Most important, the number of deaths from lung cancer was almost exactly the number of deaths predicted.

 

We have always thought of lung cancer as an almost uniformly fatal disease.  That’s because chest x-rays don’t find these small nodules early, and most patients aren’t diagnosed with lung cancer until they develop symptoms.  When that happens, the disease is usually advanced and beyond the hope of cure with currently available treatments.

 

The spiral CT scan gave new hope to those who thought that finding lung cancers early would improve the outlook for patients with this disease. These scans can find small lesions in the lung earlier than chest x-ray. The thinking has been we should be able to do for lung cancer what we’ve done to breast cancer using mammography, for example, and prevent many cancer deaths.

 

But here’s the twist: More recent evidence suggests that in fact there may be lung cancers present which do not cause a person significant problems through their lifetimes.  This is not unlike the situation that occurs with prostate cancer, where many of the cancers we diagnose through screening—and treat—may never cause a man harm or death.

 

The problem is that we can end up treating many more people than really necessary to help a few. 

 

In fact, as pointed out in an editorial in the same issue of JAMA, the cancers diagnosed by CT scan are indeed slow growing.  That may explain why they are less likely to cause symptoms and harm, perhaps even death.

 

If CT scans were catching tumors that were precursors of significant, even deadly cancer, then we would have expected to see the risk of dying from lung cancer diminish over time after CT scans started being used, when an initial rise in the number of lung cancers was detected.  That simply did not happen in this study.

 

The editorial concluded that we need to be cautious before we wholeheartedly and enthusiastically embrace CT screening for the early detection of lung cancer.

 

If this study is correct, the practical implication is that we would see many more people diagnosed with lung cancer. 

 

Already the American Cancer Society predicts there will be 213,380 people diagnosed with lung cancer in the United States in 2007, and 160,390 deaths.

 

If you apply the findings of this study, we theoretically could diagnose more than 500,000 people with lung cancer (assuming every smoker and former smoker was screened, which is not likely to happen), and still see the same number of deaths.

 

As a result, we would have many more lung cancer survivors, and many more people grateful that we were able to save their lives. 

 

But the fact is we would have done nothing to reduce the number of people who died from the disease, and that is really where we need to focus our efforts.

 

I suspect that, in the end, neither the optimism of the first report nor the pessimism of the second report will prevail.  There are other trials underway which I believe will give us a better insight into whether or not screening has a benefit in decreasing deaths from lung cancer.

 

In the meantime, if you are a heavy smoker or a former heavy smoker and want to get a chest CT scan to look for early lung cancer, it is important that you know the facts as they exist.  And, you need to have a very careful and complete discussion with your health care professional regarding the potential risks and benefits of getting screened.

 

But for the nation as a whole, it is simply too premature to make a blanket recommendation that everyone at risk be screened.

 

We look forward to more information from the ongoing clinical trials to provide us with the guidance that we really need to answer this paradox and resolve the dilemma these two studies have created.

Virginia Is For Smokers, Not Lovers

by Dr. Len March 04, 2007

 

A simple moment last week made me realize that I really don’t appreciate having cigarette smoke along with my lunch.

 

Maybe I’m just getting older and, in some ways, a bit less tolerant.  But this little episode reminded me how far we have come in terms of our expectations regarding second-hand smoke in public places.

 

As I have mentioned before in this blog, my wife and I travel quite a bit for various professional and personal activities. Last weekend, we happened to be in Pentagon City, Virginia while she was attending a medical organizational meeting.

 

On Sunday, we were caught in the middle of an ice and snow storm.  Although seated on the plane at 6AM, the flight was cancelled because of the weather and we trooped back to the hotel to wait out the storm.  The hotel happened to be attached to a large shopping mall.

 

That afternoon, we decided to go to lunch at a well-known chain restaurant which was located in the mall.

 

When we were seated, we asked for a non-smoking section, knowing full well that Virginia is far behind other states when it comes to controlling public smoking, including in restaurants.

 

We were seated near the bar, which in itself wasn’t a problem.  The time was about 2:40PM.   There were 3 or 4 other tables seated in the same area.

 

And, then it happened.

 

Shortly after 3PM, the host sat a table of four a couple of spots away from us and the other guests.

 

Out came the cigarettes, and the puffing promptly started.  Soon the area was filled with cigarette smoke (which was an accomplishment, since there was no wall between the smokers’ table and the mall.  So, in a sense, it was a very open space).

 

The next event was at the table next to the smokers, where two young women were sitting.  It became evident quickly that they were very, very uncomfortable with the cigarette smoke.  They promptly began waving their hands through the air to dispel the smoke, and complained to their server.

 

Another table next to us promptly asked to close out their tab, and left the restaurant.

 

Our lunch was served, and we ate our meal under duress.

 

The puffers puffed on.

 

As we left the restaurant, I asked the host why he sat us in a smoking area when we specifically asked for a non-smoking section.

 

His answer floored me.  He told us when he sat us at about 2:45, the area was non-smoking.  It became a smoker’s area at 3PM.   Too bad.

 

To say the least, I thought this was one of the most ridiculous things I have heard in a restaurant in a long time.  By then, the manager was with us, and I told her also what I thought of their bizarre policy.

 

So much for taking care of the customer.  “Caveat emptor” appears to be the rule of their day.

 

We then went back into our hotel, which happened to be one of those nicer chains that is known for being very accommodating for their guests.

 

I realized then that we were in Virginia—a notorious smokers’ paradise—and we hadn’t had a similar experience in this particular hotel.

 

We came across one of the hotel managers as we walked in, and I asked him what their policy was.

 

He proudly declared that, since they are a member of an international chain that has gone smoke-free, they had to ban smoking in their hotel.

 

Prior to that time, he told us, they had limited smoking to a few tables in their restaurants and lounge area. He indicated that one of his greatest job-related stresses was that he had numerous guests complaining about the smoke while he was trying to accommodate some of his regular clientele who were smokers (I found out later that this particular hotel has hosted a number of very well known international figures).

 

When the hotel smoking ban went into effect, he continued, his stress level eventually went way down, and his business went way up.

 

His non-smoking customers no longer pestered him.  His smoking customers asked if he no longer liked them, but they eventually understood the policy was real and was going to be enforced.  They adapted.

 

He also admitted that he was a smoker and had to learn to go outside to consume his cigarettes.

 

This episode reminded me of another similar eye-opener that happened to us back in September in a hotel not far away in Alexandria, Virginia back in September.

 

Once again, my wife and I were attending a committee meeting.  The hotel was part of another chain, and was more of a business meeting oriented type of place.  This chain has not gone smoke free.

 

In this particular venue, we were in meetings downstairs when we realized we smelled tobacco smoke throughout the public spaces.

 

Once again, we realized, the great state of Virginia allows smoking in public places, including the wide open lounge area one story up.  The air—and the smoke—circulated throughout all of the public spaces.

 

Eyes were tearing, people were annoyed, and the attendees once again advised our staff that our meeting should never come back to a non-smoking venue.

 

Las Vegas is another episode that still sticks in my mind, and I have written about that previously.  There, again, the meeting attendees made it very clear through a successful resolution that we never wanted to come back to a hotel or meeting space that permitted smoking.

 

I must admit that this is an issue that has grown on me.

 

When I was younger, smoking was generally acceptable in all sorts of public spaces.  Restaurants, grocery stores, offices—you name it, you could smoke.

 

But now I am older, and I cringe whenever I smell tobacco smoke in a public place.  I just don’t like it.  My wife doesn’t like it.  My friends don’t like it.  And it certainly can screw up a good meal.

 

One of the more amusing sights that I have seen with increasing frequency while driving is smokers in cars holding their cigarettes outside the car through a wide open window while they are driving and smoking.  Heck, even they don’t seem to like it.

 

So, Virginia, you may proclaim you are for lovers, but I think you are for smokers.  I understand the politics you face, especially since you are home to a lot of tobacco farmers and cigarette makers who have employed your citizens, filled your coffers with taxes (although not so much on cigarettes) and spent considerable sums on philanthropic endeavors—not to mention the probable sizeable donations they make to your politicians.

 

But the air in some of your restaurants and some of your hotels stinks.

 

You are one of the cradles of liberty.  “Give me liberty or give me death” was your rallying cry.

 

Now, I suggest, maybe it is time you rethink the meaning of those hallowed words.  I no longer have the freedom to enjoy myself in your restaurants, and you may be sowing the seeds of death with exposure to second-hand smoke. 

 

More surreptitiously, you may be sowing seeds of financial difficulties when a few more people like me start to stay away with our meetings and our money.

 

Plain and simple: We may be lovers, but we don’t want to come back.  We no longer want to smell your smoke.

Filed Under:

Prevention | Tobacco

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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