Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

The American Cancer Society

Early Detection for Breast Cancer: No More Doubts

by Dr. Len October 26, 2005

No sooner had I posted my Tuesday blog on the role of tamoxifen in the adjuvant treatment of women with breast cancer than the New England Journal of Medicine comes out with an article detailing the benefits of screening and adjuvant treatment.  In my opinion, this is a very important if not momentous article summarizing the real advances in the treatment of breast cancer that have been made over the past 30 years.

 

Let’s try to put this in perspective (it may be worthwhile to go back to my posting of 10/12/05, where I talk about the real measure of progress in the treatment of breast cancer). 

 

In the past, I used to give talks to doctors and occasionally patient groups about the treatment of breast cancer.  What confounded me and my audience during those talks was the fact that despite our best efforts to provide mammography and adjuvant treatment to women with breast cancer, we didn’t see any decrease in the rate of death from the disease going back, many, many years.  The death rate remained flat on the graph, meaning no improvement despite all of the advances we thought we were making.

 

Couple that observation with the stinging criticism some experts and the American Cancer Society (along with other reputable groups with an interest in breast cancer) were subjected to claiming that there was no real change in mortality as a result of breast cancer early detection screening with mammograms. 

 

Well respected experts said that we were seeing what is called lead time bias, not real changes in the disease process when we claimed that mammograms were saving lives.  In simpler terms, we could diagnose a cancer early, but in fact the end result remained the same: women still died from the disease at the same time they would have otherwise.  Basically, the critics claimed, we didn’t change the date of death despite all of our treatments and “early” diagnoses.

 

There were others (and they remain) who were very vocal critics of the whole concept of mammography based on their various analyses of the clinical trials that suggested mammograms reduced deaths from breast cancer.  The studies weren’t well done, they claimed.  There were errors in the interpretation of the studies.  We had been duped by our own enthusiasm, according to the critics.

 

But something started to change around the early 1990’s.  Despite a rising incidence of breast cancer, the rate of death did indeed start to decline.  And that has continued to the present day.  The American Cancer Society has predicted a continuing decline in the rate of death from breast cancer, so long as women continue to get mammograms and have access to appropriate adjuvant therapy.

 

The arguments began to shift.  More people were convinced that mammography was beneficial in reducing deaths from breast cancer, while others said it was the benefits of new adjuvant treatment programs with hormone agents and chemotherapy.   It was interesting to hear these discussions (disputes, if you would).  From my point of view, it made no difference which was responsible.  What was important was that change was happening, and the cure rates for women detected with localized breast cancer were climbing to levels that never would have been dreamed of 20 or 30 years ago.  Women were being treated with smaller cancers, and fewer of them had lymph node involvement at the time of diagnosis.  These are the factors that have a real impact on survival from this disease.

 

Now we have an elegant research paper that tries to estimate the impact of mammography and adjuvant treatment on the rates of death from breast cancer.   They start from point zero, which was the case 30 years ago when we didn’t have widespread available mammography, and adjuvant chemotherapy was a research interest only (I recall participating in some of the early group trials of adjuvant therapy in breast cancer.  I have often wondered what happened to the women we treated in those early programs, and whether or not they were helped.  They were certainly brave pioneers in uncharted waters at the time).

 

The paper uses some very fancy statistical models, and a novel level of cooperation between different groups to develop their models.  But all agreed that the impact of screening and treatment had been significant and that the benefit of mammograms and adjuvant treatment reduced the rate of death from breast cancer from about 25 to 38% from 1975 to 2000.

 

To my colleagues who have been at the forefront of this revolution, our admiration.  To organizations such as the American Cancer Society, the National Cancer Institute, and many others who funded the research and promoted the benefits, our thanks.  And to the women who participated in the trials that made this happen, we couldn’t have done it without your help and understanding.

 

There is, once again, a core message that cannot be overstated:  If you are a woman age 40 or over, and are at average risk (without a family history or some other indication of increased risk for breast cancer), you need to get a mammogram every 12 months.

 

None of this research, and none of these advances mean a thing if you don’t do everything you need to do to find the cancer early.  And the best way we know of doing that is a regular, annual mammogram.

 

If you are a woman, there are no longer any excuses to not take care of yourself.

 

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Tamoxifen and Adjuvant Therapy for Breast Cancer

by Dr. Len October 25, 2005

An article was just released yesterday by the journal Cancer, which is published by the American Cancer Society.   It deals with the question of whether or not adjuvant therapy with tamoxifen extends the lives of post-menopausal women treated with tamoxifen after primary treatment for breast cancer.

 

Ordinarily, I wouldn’t have paid much attention to the article for a variety of reasons, some of which are noted below.  But several calls in response to a press release from the journal prompted me to take a closer look. 

 

Tamoxifen is a drug that has been around for many years.  I recall in the mid 1970’s when it first became available for the treatment of postmenopausal breast cancer.  It was the first real alternative to estrogen therapy.  Yes, you read that correctly:  high dose estrogens were one of the primary hormonal treatments for women with breast cancer.  And, they were effective although they did have side effects.  We also used progesterone, and, not infrequently, prednisone.  All of these were effective, and all had limiting side effects.

 

Then, along came tamoxifen.  For oncologists at that time, it was close to a wonder drug:  few side effects, a high degree of effectiveness, and a high degree of acceptance by patients.  As an alternative to some of the other hormonal agents, and especially as an alternative to chemotherapy drugs with all of their attendant side effects, it was truly a blessing for many of our patients.

 

As years went on, side effects from tamoxifen became evident.  Most notable were the increased incidences of venous thromboembolism (blood clots forming in the veins of the legs and traveling to the lungs) as well as cancer of the uterus.  Although these side effects were and remain uncommon, they became of concern. 

 

Eventually, a new class of hormonal-type agents called aromatase inhibitors was developed.  These drugs are now demonstrated to be effective in both the adjuvant setting after the primary treatment of breast cancer, as well as for recurrent disease in post-menopausal women who have hormone sensitive breast cancer.  They are moving into the mainstream, and for post-menopausal women they represent another viable option for the treatment of breast cancer.

 

As clinical trials for the adjuvant treatment of women with breast cancer progressed, it became evident that tamoxifen was effective for women with early stage breast cancer in preventing recurrence after primary treatment. One trial, reported in 1996 by the National Surgical Adjuvant Breast and Bowel Project, found that tamoxifen was effective in both pre- and post-menopausal women with truly early stage breast cancer (no lymph node involvement with cancer at the time of primary treatment). It significantly decreased the risk of recurrent breast cancer in all age groups. They also found that five years of treatment with the drug was sufficient to see the benefit and that, in fact, more treatment may be detrimental. 

 

Tamoxifen is now considered a standard adjuvant treatment for many pre- and post-menopausal women who have primary breast cancer that is hormone sensitive.

 

The current study in Cancer, from a group of Italian investigators, looks at women who were treated with either two or five years of adjuvant tamoxifen in a study that took place in 1989 through 1996.  In this report, the researchers “looked back” at these women and determined whether there was any difference in their death rates 12 years later after they had been treated on one of the two regimens.  The women who participated were ages 50-70, and assumed to be post-menopausal.

 

Previous reports from this trial had demonstrated that there was in fact a benefit to 5 years of treatment with tamoxifen, compared to women treated for only 2 years, but there was no increase in overall survival.

 

The current study now reports that, on further analysis, women who were under 55 at the time they started the treatment had both an improved disease free survival and overall survival, but that women ages 55 and over had a similar improvement in disease free survival, but not overall survival.  And, they report, it took 9 years for the difference in survival to appear in the younger women.

 

If this information confuses you, you are not alone.  There are experts who understand the nuances of these various studies and somehow can keep all of them in mind and in some sort of order when they try to analyze the totality of the information and what it means. Make no mistake: there is a lot of digesting of a lot of information before it gets to the point where it is really needed, and that is in the care and decision making for a single patient.

 

The phone calls from the reporters were asking me what does this study really mean and how will it impact the care of women currently taking tamoxifen for the adjuvant treatment of breast cancer.  My response was that it was hard to tell. 

 

From a scientific point of view, there were several problems with how the study was constructed.  We know more now about how to do these types of studies than we did 15 or 20 years ago.  How we randomize patients into a trial, how we analyze the data using what we call “intent to treat” (that is, if you are randomized to a treatment you are considered part of that group no matter if you stop the treatment after the first dose), how we carefully pick out our primary goals of the study and how we determine in advance how many participants we need to best answer the question under investigation are some of the considerations in trial design that may not have been as rigorously followed in the past.

 

As a result, we now have more confidence in the results of our trials than may have been the case in some circumstances in the past.

 

Unfortunately, this trial didn’t have the benefits of currently accepted trial design, as was the case for many trials of that era.  And the follow-up, although thorough for the question of whether the participants were alive or deceased, didn’t tell us whether the patient died from breast cancer or another cause.  This could have told us if the women treated with tamoxifen may have died from causes other than breast cancer and may have avoided the pain and suffering that can come along with recurrent disease.

 

So what did I tell the reporters?  First, in my opinion, this study really doesn’t add much to our current thinking about the treatment of breast cancer.  Second, we are moving into a new and more complicated era in the adjuvant treatment of women with breast cancer who are post-menopausal and have hormone sensitive disease.  This is especially true given the more recent reports of the effectiveness of the aromatase inhibitors.

 

My bottom line message was this: it is important for a woman to be informed about what her choices for treatment may be.  And if she senses some confusion when confronted with all of the available information, she shouldn’t feel alone.  Even people like me (who hopefully have some knowledge about this condition) can’t remember everything that has been written.  But, most importantly, aside from a woman herself being informed, she needs to have a physician who is also informed and can explain rationally what treatment she or he is recommending, and why. It is the doctor’s responsibility to help guide you through the thicket of information so you can make the best decision for yourself.  That’s what a good doctor is supposed to do.

 

What I also told the reporters was that I hope their stories on this report will underscore the need for women to speak with their physicians about their treatment, and not take this report as a signal that tamoxifen is not an effective drug.  Far from it.  Tamoxifen has withstood the test of time and served us well.  There may be other therapies that appear to be more effective used either alone or following several years of tamoxifen, but in the right place, in the right time, for the right woman tamoxifen has proven itself again and again.

 

We’ll see what the news reports say.  Hopefully, they will “get it right.”  But, then again, they may not. In situations such as these, your oncologist should be your best guide.  If they are not, maybe it’s time for a talk.  And if you are still confused, give us a call at 1-800-ACS-2345 or check us out on the web at www.cancer.org and we will be glad to help.

 

 

Another source of information that I turn to repeatedly regarding the treatment of cancer is the National Comprehensive Cancer Center Network site at www.nccn.org.  They have professional guideline algorithms which in my opinion represent the best example of what I call a “living guideline.” These are regularly updated and represent the best consensus recommendations of highly regarded oncologists and cancer centers.  There is also some rather direct comment in the “manuscript section” when the experts don’t agree, which is unusual in any published guideline report. 

 

Patient-friendly versions of their guidelines are also available for several different types of cancers through NCCN and the American Cancer Society contacts noted above.

 

 

One other brief postscript:

 

I took a look at my schedule yesterday and noted that I will be traveling for the next several weeks.  I will do my best to put up regular postings during this time.  For the next several days I will be out of the country, and will hopefully be able to find time and a safe internet connection.  If I don’t, I hope you will understand.

Filed Under:

Saving Lives, Saving Worlds

by Dr. Len October 21, 2005

I attended a meeting today where there was discussion between American Cancer Society staff and an outside organization with whom we work very closely.  The purpose of the meeting was to review a number of projects we work on together, and review the progress being made on those projects.

 

I was struck during that meeting about how much cooperation has to occur in so many ways in order to make progress in reducing the burden of cancer.  I was also impressed about how necessary it is to pay attention to so many details and so many programs and opportunities, if we are going to be successful in our efforts.

 

It is sometimes difficult to get one’s arms around all of the different elements that must come together in order to do something successfully.  This isn’t a concept unique to the American Cancer Society.  You can probably relate to this in your daily work or other activities.  You have an idea, you develop the idea, you get buy-in, and that’s only the beginning.  The road to successful implementation is arduous and frequently the barriers can overcome the good intent.

 

It’s no different when we talk about concepts such as screening for the prevention and early detection of cancer, which occupies the major focus of the department I manage at ACS and was one of the core purposes of the meeting I mentioned above.

 

I’ve had the opportunity on a number of occasions recently to step back and consider the incredible series of events that have had to occur in order to get to the point where you can say that the scientific evidence is sufficient to create a guideline for the prevention and early detection of cancer, and the follow-up that has to occur to get the guideline accepted to the point where is actually impacts people’s lives.

 

Take mammography, for example. First the science had to develop to show that mammograms actually reduced the burdens associated with breast cancer. That started in the 1960’s.  Then a guideline had to be created and publicized. Insurance companies had to be persuaded to cover screening mammograms.  We needed to put quality programs in place to insure that mammograms were performed to a reasonable standard.  Congress and Medicare had to be convinced to authorize the screening benefit under the Medicare program, and women had to understand how life-saving the test can be.  Then there were the doubters and naysayers who said it didn’t make a difference.  And now we have to be certain that every woman who should have a mammogram and wants a mammogram can get a mammogram. 

 

This has taken us over 30 years!

 

In order to have successes like this, I am convinced that everyone must participate in the process.  It’s not just about doctors and patients.  It is  about communities, employers, insurers, local, state and federal governments, the CDC, the Cancer Society, the National Cancer Institute, other voluntary not-for-profit health organizations and anyone else who is concerned about this or any similar issue.  More often than not, the pieces of the puzzle don’t fall into place by chance.

 

Another example of partnerships resulting in action based on science was research that demonstrated doctors were not doing a routine screening test for colon cancer properly. 

 

After the report, the next step was to figure out how to change doctors’ behaviors. After all, this test (called fecal occult blood test or FOBT) is actually the only test that has been proven to reduce deaths from colorectal cancer.

 

The CDC, ACS and others worked together on performing and reporting the research, and a leading medical journal confirmed the importance of the research in a sharply worded editorial that basically called physicians to task for their failing to follow current recommendations.  Here is a situation where there is scientific evidence that we can reduce the pain and suffering from colorectal cancer, and actually may be able to prevent the disease in some circumstances (there is one estimate that 30,000 lives a year could be saved if we screened properly for colorectal cancer).

 

In response, another coalition formed to promote a code used by doctors for payment for medical services that specifically defines the right way to do the test.   This was the result of an effort by a number of people, including government agencies, insurers, and medical associations.  The code was passed, and we anticipate it will highlight to doctors how to do the test properly. 

 

Hopefully, lives will be saved.  But, once again, no one can rest on their laurels:  insurers have to pay the code properly, Medicare needs to adopt it as the standard code for the service, and national accrediting organizations have to change their quality measures to require this code as opposed to any other in order to prove that proper colorectal cancer screening has been done.

 

I could go on, but I suspect you get the point.  These events don’t happen by chance or without a lot of thought.  They can take a long time to work themselves through the “system.”  It takes constant attention and vigilance by a significant number of people and organizations to keep the focus on the issue and the program.  It requires frequent reminders and publicity to keep the issues and the recommendations in front of people and the medical community.  And maybe, just maybe, when everything is said and done you will have had some impact on the lives of people and their families.

 

I am reminded of a phrase that was on the wall of the hospital where I worked in Baltimore a number of years ago.   It said, "He who saves a single life, saves the entire world." 

 

I doubt the participants in this morning's meeting were thinking in those terms, but I suspect their persistent efforts have saved a whole lot of worlds in ways they will never know.

 
 

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Herceptin (Again) and the News is Still Terrific

by Dr. Len October 19, 2005

The American Society of Clinical Oncology held its annual meeting in Orlando this past May.  There were a number of papers presented that were very interesting, especially in the area we call “targeted therapies.”  My impression of that meeting was that we had finally reached a watershed moment in cancer treatment, and in fact had seen the validation of these targeted therapies as a legitimate, effective new treatment strategy for patients with cancer.

 

But one session in particular was, to say it mildly, incredible.  I have attended these meetings since the early 1970’s.   I had never seen anything like I saw that day in Orlando when there were presentations by several research groups describing the results of their clinical trials with a drug called Herceptin.  I have been to concerts and theaters in the past, and the exultation of the audience following each of these presentations was hard to believe for a medical research meeting.

 

What these various research groups had done was to treat women with a particularly aggressive form of breast cancer with a targeted therapy called Herceptin as a preventive therapy.  Their studies showed that the use of Herceptin in these women decreased the chances of recurrence by around 50%, or one half, in a relatively short period of time.

 

Having heard the presentations, my sense was that we had seen a moment in medicine and patient care that happens rarely: a study (or studies) that are so compelling that they truly change the standard of care for the treatment of our patients overnight. 

 

But there is always that nagging caution that maybe the results were premature, or that perhaps the data wasn’t accurately analyzed, or that the study had not been as well done as it seemed at that time.  Remember, we were reacting to a presentation that lasts for a couple of minutes, with some time left over for questions.

 

Experience has taught us that it is usually best to wait until the study is published in a peer-reviewed journal before accepting it as truly legitimate.  Peer review offers the opportunity for experts in the field to meticulously review the information and the data from the study, see if there are problems, and decide whether or not the study should be published.

 

The wait is now over for the Herceptin studies.  They were published, along with an editorial, in today’s edition of the New England Journal of Medicine, which is arguably the leading clinical medical journal in the United States if not the world.  And we were not disappointed by the results.

 

Let me try to put this event into perspective.  About 211,000 women will be diagnosed with breast cancer in the United States in 2005 according to estimates from the American Cancer Society.  Of those 211,000 women, about 15-20% will have a cancer which is positive for a receptor found on the surface of their cancer’s cells called HER2, according to another paper in the same issue of the Journal.  Women who are HER2 positive have a more aggressive form of breast cancer, and are known to have a poorer prognosis, poorer response to chemotherapy, less responsiveness to available hormone treatments, and relapse earlier than women who are not HER2 positive.

 

Herceptin is a drug (in fact, an antibody) that was developed to “attack” this HER2 receptor.  It has been used for several years as a treatment for advanced, recurrent breast cancer in women who have had the receptor identified in their breast cancer tumor by sophisticated laboratory tests.

 

If the drug was effective for women with advanced breast cancer, then it is reasonable to ask whether it might be even more effective if used in women as part of an adjuvant, or preventive, treatment program after the woman had received her primary treatment for breast cancer and before the cancer recurred.

 

The problem with this approach, aside from whether or not it would be effective, was that this drug is known to cause heart failure and sometimes heart-related deaths in a small but significant number of women.  From a medical perspective, it is one thing to have heart failure occur in someone who has had their disease spread and there is little else available which might help control her cancer.  It is a different circumstance when a woman may be young and otherwise helpful aside from her breast cancer. 

 

That is the question that was addressed and answered in these studies.  The details are frankly fairly intricate as to how these clinical trials were constructed and conducted.  But the bottom line is that Herceptin did indeed reduce the chance that the cancer would come back in both studies. 

 

In one international study, about 3400 women participated in a trial where ½ of the women received Herceptin after standard adjuvant chemotherapy, while the others did not receive Herceptin.  In that study, the women treated with Herceptin had about 46% fewer recurrences than the women who did not receive Herceptin.  These women had been followed for up to 36 months, which is important since many of the recurrences in women with HER2 positive breast cancer relapse within 18 to 24 months after their primary treatment.

 

In the other study, done primarily in the United States, about 3500 women participated in two similar clinical trials.  In this study, there were 52% fewer recurrences in the Herceptin treated group.

 

In both groups, there were women who developed congestive heart failure, which occurred in up to 4.1% of the women in one of the trials despite careful monitoring of heart function.  In the United States trial, almost one out of three patients did not complete the one year of Herceptin treatment for a variety of reasons.

 

As to improved survival, the international study still hasn’t shown a difference, but that may be because it is still too early to see this benefit of the treatment.  The United States study clearly shows a survival benefit.

 

In words that are rarely used in a medical journal, the editorial says, “The results are simply stunning.”  And I certainly agree.

 

Here we have a situation where doctors had something to offer, but that “something” was not as effective as we would like.  And, then, reports such as these come along and we have a treatment that may not just delay the recurrence of breast cancer but in fact just might mean a cure for some of these women.  As noted by the editorial, “This observation suggests a dramatic and perhaps permanent perturbation of the natural history of the disease, maybe even a cure.”

 

Dr. Hortobagyi from M.D. Anderson Hospital in Houston, who wrote the editorial and is a highly regarded expert in the treatment of breast cancer, is not alone in his enthusiastic endorsement of these reports.  He also cautions that the studies raise as many questions as they answer, and he emphasizes the need for additional clinical trials to answer those questions.

 

I can’t go further in discussing these exciting developments without acknowledging the contribution made to science, medicine, and the women with breast cancer who will benefit from this new knowledge without making a special mention of the women, their families and their physicians who participated in the clinical trials that made this research possible.  Without them, we never would have made this significant piece of progress.  And without the women who follow, we will not be able to advance our knowledge and care of women with breast and other cancers.

 

So there it is: a “rock star” moment.  It may not appear so in the dry words of this blog on the internet, but I can assure you there are doctors, patients, families and friends who have reason to celebrate that there is confirmation of some very exciting news they first heard about in May.

 

The applause may not be deafening, but the impact is immeasurable.

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Tobacco and Smoking: It Just Won't Quit

by Dr. Len October 18, 2005

It just won’t go away, this tobacco thing.  I wish there was something else as interesting to write about today, but I guess this is probably as important as it gets.

 

My day started out at breakfast with a newspaper article discussing the Supreme Court ruling indicating that the tobacco companies once again escaped the noose.  They are off the hook for $280 billion in potential damages for their past wrongs.

 

The CEO of the American Cancer Society, Dr. John Seffrin, said it well: “Tobacco companies must be held appropriately responsible for deceiving the American public about the health risks of smoking and exposure to secondhand smoke, the addictiveness of their products, and their marketing to children.”

 

How many lives, how much in wages, and how many years of life and love lost do we need to make us get this right?  $280 billion, believe it or not, probably wasn’t enough given the magnitude of the problem.  And now that opportunity is lost on a legal ruling.

 

But that isn’t the only issue that got my attention today. 

 

For example, there was the story in USA Today about the benefits in Ireland from their smoking ban.  According to the story, there were 17% fewer non-smoking bar workers who had respiratory illnesses.  Employees had lower levels of nicotine byproducts in their blood, which means inhalation of less tobacco smoke.  And, surprise, the vast majority of Irish folks thought the ban was a good idea.

 

Counter that with the information out of Chicago where Crain’s Chicago Business reported the money the restaurant association has taken from the tobacco companies for a number of years.

 

In another opinion piece in the same newspaper, the president of Blue Cross and Blue Shield of Illinois noted the increase in tax receipts and employment in restaurants in New York after they instituted a city-wide ban.

 

Even Japan is getting the message.  There has been a decline in the number of smokers, although 45.8% of men still smoke.  But, progress is sometimes slow—as the lessons of the past many years have shown us here in the United States.

 

Another story highlighted the decrease in tobacco sales to youth in New Mexico.  They attributed the decrease to education of merchants and increased enforcement of the law.

 

In Buffalo, New York a restaurant owner is suing a county health commissioner because the commissioner enforced the state’s smoking ban, and the owner says the ban is responsible for destroying his business.

 

And there is more…

 

Here in Georgia, we are have another twist on a familiar story: how strict should a smoking ban be?  Some counties had put into place strict smoking bans, which meant no smoking in a public place.  Then, the state legislature passed a law which was not as comprehensive and allowed smoking if you kept out customers and employees if they were under age 18. 

 

Challenges to the stricter laws are currently underway in Gwinnett and DeKalb Counties, which are both in the Atlanta area. There are some very creative arguments on the table, which conveniently forget the fact that it isn’t just the kids who are at risk from second hand smoke.

 

I am left to conclude, since I am older than 18, that it’s ok for me to be exposed to second hand smoke.  But I don’t want to have a drink and a meal where I am exposed to tobacco smoke.  And I don’t want to have to smell like a cigarette after going out for dinner.  And I don’t think I am alone, especially since for every smoker, there are 4 people who don’t smoke. 

 

Who’s in charge here????  I bet many of these establishments don’t provide health insurance for their employees, so they don’t have to bear the indirect healthcare costs of workplace smoking exposure except through the taxes they pay to support a failing Medicaid system here in my home state.

 

My daughter lives in New York, and supports herself working in restaurants and bars while she pursues her acting career.  I asked her how she felt about the smoking ban, since her livelihood depends on customers patronizing these businesses.

 

Her response was immediate and direct: she was thrilled that she didn’t have to work in a smoke-filled environment, and she was glad she didn’t have to smell like a cigarette when she left work.  And, as her dad, I’m thrilled that she isn’t exposed to what I consider a clear and present damage from second-hand smoke.

 

So, these are thoughts from just one day’s coverage in the press.  Quite a collection, but it demonstrates how important and critical this issue is here in the United States and internationally as well.

 

Political manipulations being what they are, my advice is for you to speak your mind, call your councilman, your senator, your representative, your whatever wherever you live and where you have these issues on the table.  If you agree that a smoking ban is the right thing to do, then your elected folks need to hear from you.  It can make a difference.

 

And, as to Chicago, which is one of my favorite cities in the country, I implore you to think this through very carefully.  I love the city, I love the people, and I love the restaurants.  But I’m having a problem enjoying myself when I try to cut through the smoke with a knife.  Do the right thing.  New York clearly has you beat on this one.  Maybe Georgia should be listening too.

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Measuring Quality: It's About Time

by Dr. Len October 14, 2005

A research article recently appeared in the journal Cancer (which is published by the American Cancer Society) which reviewed errors in cancer diagnosis.  The research, performed at four reputable hospitals, made an effort to determine the number and impact of errors in cancer diagnoses made by pathology labs in those hospitals.

 

The title of the article was “Clinical Impact and Frequency of Anatomic Pathology Errors in Cancer Diagnoses.”  The authors went on to say that about 300,000 patients were harmed as a result of basically botched diagnoses.  In fact, they said that if different parameters were used to calculate the error rates, the number of people harmed would be much greater.

 

This is the type of article that points up several of the flaws in our medical care system, and highlights the difficulties the media has in trying to make sense of a complex story in the limited amount of space or time they have to provide their reports.

 

Basically, what these researchers did was look at the diagnoses that resulted from a cytology (think Pap smear) or needle biopsy specimen, and compared them to  subsequent surgical specimens biopsied from the same lesion.   If the two diagnoses agreed, fine.  If they didn’t, they further examined the specimen and the circumstances to determine what was the cause of the discrepancy, and how much harm actually occurred.  (What I call a “discrepancy” they called an “error.”)

 

The doctors tried to determine whether the error was caused by a true misinterpretation by the pathologist, or by what is called a sampling issue (which means when the needle was stuck through the skin into a nodule, for example, it missed the area with the cancer so no cancer cells showed up on the pathology slide, when in fact the lesion was cancerous).  They then looked at the medical records, and tried to determine whether or not the error made a real difference in the care of the patient.

 

What they found was that sometimes even the pathologists couldn’t agree on whether or not an error had been made on some of the specimens.  Some of the hospitals had high error rates based on where the specimen was obtained (for example, there was a high rate of error in one hospital for samples obtained from the lining of the lung, while another hospital had no errors in specimens from this area).  Another problem was that some hospitals thought a significant number of the errors caused real harm, while other hospitals couldn’t seem to find any errors that caused serious harm.

 

What this suggested to the authors was that, despite their best efforts, not everyone looked at the reviewed material the same way, and different hospitals and pathologists came to different conclusions.

 

This confusion doesn’t mean the study was a failure.  Far from it.  In fact, it represents an excellent initial effort to try and define what we mean by quality in this particular type of medical practice, how we can accurately measure that quality, and how we can use the data to improve the care we offer our patients.

 

So, rather than looking at this as a completed project, I agree with the authors that it represents a beginning.  As to the large numbers of patients “harmed,” when I took a look at the criteria used to define harm, the differences in rates of harm of different severities at the different hospitals, and tried to determine what the real risk was, I came out with smaller numbers.  Probably this was because I was most concerned about the patients who had what the authors called grade 2 (moderate) or grade 3 (severe) harm, where treatment was delayed, unnecessary invasive tests or biopsies were performed, or the patient lost their life as a result of the doctor’s mistake.  Looked at in this way, the real harm was substantially less than the numbers noted above and likely a lot more realistic.

 

What gets lost in the translation of an article like this is that doctors who care for patients don’t work in a vacuum.  Just because they get a diagnosis that suggests no cancer is present doesn’t mean they are necessarily satisfied.  They use their judgment, and make decisions based on all of the clinical evidence they have at their disposal.  They know that if they needle a suspicious mass in a breast, for example, and it comes back without evidence of cancer, that they may still go ahead with another procedure because the negative result doesn’t fit with their clinical sense of what is really going on.

 

Some other points are also worth making, however, that go beyond the comments of the authors and that the study actually brings into focus.

 

First, getting this study done was no small task.  It was funded by a grant from a federal agency and was put together very thoughtfully.  In the real world, however, we don’t have grants to hospitals and labs to help defer the costs of doing this type of review, which is very labor intensive.   In this era of decreased reimbursement for medical services, no one wants to pay for this type of quality management program.

 

What we have is an elegant research effort, but we still have to figure out how to improve it, how to make it more practical, and how to make it more acceptable to those who have to pay for it and those who have the quality of their work measured by such a program.

 

That brings me to the second point, which has concerned me for some time.  If we are going to improve the quality of patient care, we need to figure out a system that lets us do just that.  We need to be able to measure quality, to give feedback to the doctors and the hospitals on the results of those measurements, and allow the doctors and hospitals to engage in efforts to improve the quality of our medical care.

 

I mentioned a similar theme in my posting last week regarding the Report to the Nation.  And I’ll repeat it again:  unless we take this seriously, and find a way to permit doctors and others to engage in quality improvement programs, we will find progress in this arena to be slow-moving and unsatisfactory.

 

My personal opinion is that it is time to establish federal legislation that will move this process forward.  Perhaps we can do it state by state, and if that works, so be it.  But right now the atmosphere regarding the quality of health care is so poisoned that it may be impossible in any venue to get this problem resolved.  We need an environment that allows us to speak openly without fear about the problems we discover.  We need a way to look at those problems honestly, and figure out how to fix our systems and processes so they won’t happen again.

 

If we don’t find a way to create a culture of quality analysis and improvement, we will have great difficulty getting systems in place to truly improve the care physicians and health care professionals provide their patients.  We need to be able to utilize the wealth of data that is now being accumulated by many participants in health care delivery (including, believe it or not, the insurance and managed care companies) which could allow us to reach out to physicians and patients in a very positive way.

 

We can’t be scared to move forward, and right now many physicians and hospitals are just that: scared.  We need to adopt a model that allows to carefully examine our problems, just as the doctors in the Cancer article did, and as have others who have reported the results of their quality efforts.  And then we need to act on those findings and improve the care we offer.

 

Cooperation, collaboration, and improvement are the goals.  We now have the tools and the incentives to do the job right.  Let’s hope we have the will to make it happen soon.

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The Real Measure of Progress in Breast Cancer

by Dr. Len October 12, 2005

I had the opportunity to appear on MSNBC yesterday.  The topic was Breast Cancer Awareness Month, which the American Cancer Society sponsors along with other organizations every October.

 

The interview dealt with several questions, including common misconceptions about breast cancer, whether women under the age of 40 are at risk for the disease, and how to get information about breast cancer.

 

What I didn’t have a chance to say is what I think is the key message women at average risk for breast cancer need to hear loud and clear:

 

All of the advances in screening, all of the research, and all of the new treatments don’t mean a thing unless you get screened for breast cancer every year—every 12 months—if you are a woman age 40 or over.

 

That simple message and that simple commitment is the key to taking advantage of everything we have learned about this disease, and how to have the best chance of curing it.

 

As you may know by now, I like to reflect on the relatively recent past (which simply stated is the duration of my medical training and medical career) as a measure of the progress we have made in medicine and the care of patients.  I firmly believe we sometimes have a tendency to lose sight of the progress we have made, and frequently fail to understand what simple steps the past has taught us to carry forward and improve the care we provide today.

 

When I started my oncology career, there was no mammography.  There were studies underway to demonstrate whether or not mammography saved lives, but that took a while and even then the studies and the technologies were crude by today’s standards.

 

The only way a woman or her doctor found breast cancer was by physical examination, or by the unusual event where a breast biopsy or procedure was done for an unrelated reason and a cancer was found by chance.

 

We were pleased when we found a small cancer by palpation (examining the breast as part of a physical examination), or when a woman did careful breast self-examination and came to us immediately for follow-up.  We praised the woman and ourselves for our diagnostic acumen and told her how lucky she was to have found the cancer “early.”

 

To us, “early” meant the cancer was around 2 centimeters, or about ¾ of an inch, in diameter.  Early meant, as I recall, there was about a 50-50 chance the lymph nodes in the axilla, or armpit, were involved with cancer.  But that only meant the woman had “regional” disease, and we had interrupted the spread of the cancer beyond the lymph nodes.  We knew with surgery we could “get it all.”

 

Once we had felt the nodule, we sent the woman for a biopsy of the breast.  She frequently was admitted to the hospital, put to sleep, and the biopsy was done.  If the frozen section was negative for cancer, she was awakened and went home with an incision, but an intact breast.  If the nodule was positive, she immediately underwent a mastectomy which meant removing the breast, occasionally some of the muscles under the breast, and had an extensive dissection of the axilla.  This procedure is known as a modified radical mastectomy, less disfiguring than the older radical mastectomy where much of the chest wall muscles were removed, but nonetheless disfiguring.

 

During the early part of my medical career and training, and following through to the present day, we have been fortunate to have our knowledge of breast cancer behavior and treatment advance exponentially. 

 

We learned through research that lymph nodes were not a “stepping stone” in the path and progress of the cancer, but in fact indicated more advanced disease.  In fact, when there was cancer in the lymph nodes, what that really meant was that the cancer had an increased likelihood it had spread to other parts of the body.

 

If lymph node involvement meant there was already an increased chance the cancer had spread, could we do something about that?  Research began into the new science of adjuvant chemotherapy.  Revolutionary at that time, and common today, was the concept that if we had chemotherapy that was somewhat effective in treating advanced disease, why wouldn’t it be more effective in treating women at risk of recurrence earlier in their disease?

 

Another question was whether less disfiguring procedures, such as a “quadrantectomy” of the breast (where essentially a large portion of breast tissue around the cancer was removed), or the subsequent “lumpectomy” (where the cancer and a reasonable margin of tissue around the tumor was removed) would be as effective a treatment for breast cancer as the prior modified radical mastectomy?  And could radiation therapy be used to improve the results, by treating other unseen areas of cancer that may have co-existed in the breast with the observed, primary cancer?

 

The answers to these questions, after much research and effort (not to mention the essential and much appreciated participation of patients, their families and their doctors), was yes. We could improve the outlook of women at increased risk of recurrence after primary treatment for breast cancer by giving them adjuvant chemotherapy, and yes, a less disfiguring surgical procedure followed by radiation therapy was equivalent in results to the modified radical mastectomy.

 

These advances have had a practical implication for women.  More women are getting screened for breast cancer—although we could do better.  More women are having their breast cancer diagnosed at an early stage—before it gets to the lymph nodes.  More women are having lumpectomies followed by radiation therapy—although for uncertain reasons a number of women still opt for the mastectomy, and other women are not receiving the recommended radiation after their surgery.  And more women are receiving appropriate adjuvant chemotherapy.

 

Until relatively recently, when I gave a talk about breast cancer, I mentioned all of the advances but pointed out that there had not been an impact on the rates of death from breast cancer in the United States.  That is, fortunately, no longer the case.  The rate of death from breast cancer in this country has been declining from the early 1990s and continues to decline, while the numbers of breast cancers continue to increase.

 

Unfortunately, not everyone is participating in the success to as great a degree as possible.  African American women, for example, have a lower incidence rate of breast cancer, but a higher death rate.  That is not acceptable.  

 

Medically underserved women and women who live in certain parts of the country have access to a program run by the states and the Centers for Disease Control and Prevention called Breast and Cervical Cancer Early Detection Program (BCCEDP) which has done a marvelous job of providing screening and treatment for breast and cervical cancer for underserved women—but only for 1 out of 5 potential beneficiaries.  The American Cancer Society through its Cancer Action Network and others are advocating strongly that this very special, and effective, program be fully funded so it can reach every eligible woman.

 

With all of the successes we have had, I continue to ask myself why every eligible woman in this country should not be able to receive a mammogram every year, and get treatment for her breast cancer as appropriate, when the chances of cure are greatest. 

 

The suffering and losses that my colleagues and I saw 30 years ago are no longer the norm.  We really have come a long way, and there should be no barrier in the way of any woman who needs screening, and no barrier in the way of any woman with the diagnosis of breast cancer for her to receive the best available treatment.

 

In my opinion, to do less in this day and age is not acceptable.

 

 

For more information on breast cancer, I suggest you consult the information on www.cancer.org and for more detailed information check out the booklet Breast Cancer Facts and Figures 2005-2006, which is also available online.

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Vaccines in Melanoma: Perhaps Some Success At Last

by Dr. Len October 10, 2005

A number of years ago, when I began my training as an oncologist, I had a special interest in the treatment of patients with metastatic melanoma and non-small cell lung cancers.

 

Both of these diseases were difficult to treat with chemotherapy, and even modest success with treatment was elusive.  One of my younger colleagues turned to me one day, and in a moment I haven’t forgotten, asked me if I had some sort of need to give hope where none existed.

 

Today, not much has changed.  For melanoma, there hasn’t been much material progress in the treatment of advanced disease.  Despite much effort, as noted on the NCI website, we have only a handful of treatments for patients with advanced disease and those treatments haven’t been particularly effective.  Survival for patients diagnosed with Stage IV melanoma remains dismal.  (It should be noted where we have made progress is in the early detection of melanoma.  That is a topic for another day.)

 

Parallel to my interest in melanoma was the development of vaccines to treat patients with cancer.  Because we could identify tumor antigens on melanoma that theoretically could stimulate the immune system, there has been interest for many years in treatment programs and models that relied in part or totally on developing ways to stimulate the immune system to recognize melanoma as a foreign cell in the body.

 

Despite the excitement, there hasn’t been meaningful evidence that developing vaccines has had any positive effect on the course of patients with metastatic melanoma.  When I am asked about this topic, and the periodic suggestions that effective vaccines may be in the works, I generally provide my conservative “I’m from Missouri: show me” response.

 

Bottom line, after so many claimed successes that turned out not to work on patients, I have become a bit cynical about new developments suggesting that vaccines are effective in the treatment of melanoma.

 

This is not to say that there haven’t been some exciting developments along the way.  My sense is that we know much more about the immune system and how it reacts to cancer cells than we dreamed of knowing 30 years ago.  We know more about tumor antigens and how to identify them in cancer cells.  We know more about how to present those antigens to the immune system of a patient with cancer to get a measurable response which might suggest there is some activity.  But we don’t have the evidence that it makes a whole lot of difference in the outcome for patients with melanoma.

 

This morning there was an announcement from a company named Antigenics that they had preliminary evidence that there may be effectiveness of their vaccine in the treatment of a set of patients with advanced melanoma.

 

In this study, using a protein called “heat shock proteins” derived from surgically removed melanoma samples from patients with advanced disease and reinjected back into the same patient after processing, there was some evidence that patients did better with the vaccine compared to those patients who received what I would call best available chemotherapy and/or immunotherapy.  According to Antigenics press release, the survival of these patients was increased more that 50%, a truly stunning report.  However, although the treatment was used in patients with advanced disease, the particular group that benefited from the vaccine had spread of disease limited to the skin and lymph nodes.

 

Unfortunately, for patients with advanced disease that had spread beyond the skin and lymph nodes (lung, liver, brain, etc.), the vaccine did not improve survival.

 

As exciting as this information may be, there are several cautions that you should be aware of.  First, not every patient who was randomized to receive the treatment actually did receive the vaccine.  Some of the patients had progression of the disease while waiting for the vaccine, so they were moved on to chemotherapy before being vaccinated.  For other patients, because of a manufacturing problem, no vaccine could be produced from their cancer.  (My understanding is that those problems have been resolved.)  Finally, although the data look interesting, they have not yet reached what we call “statistical significance.”  What that means is that there is not enough certainty in the data as of today to say that the results are as solid as we would like.  We need that certainty before we can say we have a reasonable degree of comfort that the benefits of the vaccine are due to the vaccine and not to some other uncertain factor.

 

The company has indicated they are going to move forward with another trial in the next several months to address these questions.

 

Perhaps, at long last, the drought of truly effective treatment for a certain subset of patients with metastatic melanoma is nearing an end.  Perhaps we will finally have a vaccine that truly and meaningfully extends the lives of a group of patients with advanced cancer, and holds out hope that other cancers will respond similarly in similar circumstances.

 

But those are big “perhaps.”  We have been down this road so many times in the past that caution and conservatism is warranted.  We hope the suggestions turn out to be right, but we still can’t say that with conviction needed to make this available to all patients without further study.

 

Needless to say, we are all waiting with anticipation for the next trial to begin.  I hope that my colleague’s pessimism of 30 years ago will finally be addressed with some solid results indicating real improvement in the treatment of patients with this disease.  I am certain there are many people with melanoma who feel the same way.

 

Note: For the record, I have had conversations with staff from Antigenics in the past.  We have had no previous discussions of the results of this or any other trial, and I have no relationship of any kind with the company.   The comments in this blog entry are mine alone, and do not represent any position or opinion of the American Cancer Society.

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The Vaccine for Cervical Cancer: What It Means

by Dr. Len October 07, 2005

My entry yesterday about information, how it is acquired, judged and utilized in advancing medical treatments mentioned the conservatism factor.  This is one of the reasons that it takes such a long time for information to get “from the bench to the bedside”, to borrow a professionally popular description.

 

No sooner had I completed the entry than I received a news release about Merck’s new vaccine for cervical cancer.  Although I had planned on continuing a general discussion of information and how it is used in medicine to move treatments forward (or not, as the case may be), I quickly decided that the cervical cancer vaccine should be today’s topic, since it is both of interest to many of us as well as an excellent example of how information flows.

 

The reduction in the incidence and deaths from cervical cancer in the United States is one of the true medical and cancer-related success stories of the past 40+ years.  The development of the Pap smear, which was until recently the standard test to detect cervical cancer and its precursors, has been the hallmark example of what can be accomplished through appropriate cancer screening.

 

Today, the American Cancer Society estimates that in 2005 there will be 10,370 new cases of cervical cancer diagnosed in the United States and 3710 deaths.  Those figures do not include the large numbers of women who are diagnosed with precancerous lesions as a result of screening and in whom cervical cancer can actually be prevented by currently available medical procedures (see this link for a further discussion of the Society’s guidelines for the early diagnosis of cervical cancer).

 

More recently, there has been considerable research leading to the conclusion that many, if not all, cervical cancers are in fact caused by a virus called HPV.  There are many different types of HPV, some of which are more likely to cause cancer than others.  But research demonstrated that, without doubt, this virus and its specific subtypes 16 and 18 are responsible for a majority of these cancers.

 

The first practical breakthrough came with the development of a screening test for detecting HPV.  As a result, ACS and others changed their guidelines for cervical cancer detection to include the option of testing for HPV.

 

As we all know, we have been able to develop vaccines to prevent some bacterial and viral infections.  Here we have one of the few cancers to have been proven to cause cancer (another common one is liver cancer, caused by certain hepatitis viruses, which can be prevented in susceptible people with early childhood immunization).  Why couldn’t we develop a vaccine to do the same for the HPV virus?

 

The answer is that we have developed such vaccines, and that is what Merck and another company (GSK) have reported yesterday and previously.  In fact, research has shown that the use of these vaccines can decrease the infection rate from HPV.  But what had not been shown until yesterday’s report was that a vaccine could also prevent the precursor lesions for cervical cancer, and cervical cancer itself.

 

The implications of this report are significant.  First, it is important to note that although we have done a reasonably good job of screening for cervical cancer (we need to do better, especially for women who are medically underserved or who live in certain areas of this country), cervical cancer remains a leading cause of death for women throughout the world.  This is especially true in underdeveloped countries where they do not have access to screening techniques available in countries like the United States and Europe.

 

Second, if this vaccine shows durability (that is, the protection lasts a long time) it will have considerable affects on what women have to go through when a pap smear is suspicious for cancer.  The anxiety, the procedures themselves and the costs of those procedures are not insignificant, and the possibility exists that the vaccine could significantly reduce all of these.  (I should emphasize, however, that we are a long way from that decision.  And, we are also a long way from finding out whether or not this vaccine will have an impact on our guidelines recommendations for cervical cancer.)

 

There remain many unanswered questions at this time, such as the durability of the vaccine.  Perhaps most prominent, and yet to be decided, is who should get the vaccine and when

 

As the company has noted in their press release, they are planning on asking for an FDA review of the vaccine in the very near future.  There is little question that, despite some of the more complicated issues to be decided, this vaccine is likely going to have a substantial impact for women in the United States and throughout the world.

 

As a side note, what I found interesting was how quickly the vaccine demonstrated that it was effective in preventing cervical cancer.  In the report of the study, about 3 women out of every 1000 developed either a significant precursor lesion or actual cervical cancer.  And this was after only 2 years of follow-up!!!  That means that the HPV virus (at least in this study) caused cervical cancer and its precursors to develop very soon after infection.  The finding emphasizes the importance of women getting screened in accordance with the Society’s guidelines which means every year for younger women.

 

This is the type of research report that will change medical practice.  I suspect it won’t take 17 years to accomplish that change.  It is the type of event that grabs the attention of the medical profession and the public who I anticipate will consider the evidence and move forward quickly once the vaccine becomes available.  It also has the possibility of significantly changing the practice of medicine, especially for gynecologists who do a substantial amount of evaluation and treatment for women who have suspicious or positive Pap smears and HPV tests.

 

There will be questions that women will have to answer for themselves once the vaccine is available.  Fortunately, at this time, there do not appear to be serious side effects to the vaccine. (We must always remember that it takes time in general use before some of these problems become apparent.)  And there will likely be considerable discussion around the question of what the age should be when we recommend starting vaccinations with this vaccine.

 

But, getting back to the information issue, this development demonstrates one of the very valuable aspects of this age of rapid information dissemination.   People will quickly develop awareness of what the vaccine is all about, and be able to make their own decisions about how they want to proceed with getting vaccinated, and what to do about their children who may be eligible for the vaccine.

 

I hope we can all agree that it is not a bad thing to have access to information which makes us better informed and allows us to make the right decisions for ourselves and our families.

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Information: How We Get It and How We Use It

by Dr. Len October 06, 2005

One of my colleagues asked me the other day to prepare some comments regarding the American Cancer Society’s role in disseminating results of research, and how we impact the movement of research information into clinical practice.

 

This is no small task. I could write a lot about this issue, since “information” is one of our organization’s nationwide priorities as well a longstanding key competency of the Society. 

 

We live in a world of information.   There is an ad currently playing on television which shows the old fashioned version of information where the newspaper delivery boy delivers the single daily paper.  Then, as the ad progresses, it shows literally hundreds of different types of information and entertainment being thrown at the house.  This is a very clear, effective example that shows how our lives have been changed by the information revolution and the impact computers and broadband have had—and will increasingly have—on our way of life.

 

What has also changed, as your kids can show you, is that there is an increasing expectation of access to information at little or no cost.  We’ve gone through the Napsterization of our information and entertainment, with the outcome that entertainment files and information are being exchanged over the internet with a fair degree of ease at little or no cost (legalities notwithstanding, which is not the focus of this discussion).

 

This evolution has produced a “free flow of information,” where people expect to have access to information.  In the worlds of science and medicine, my colleagues are concerned that this access is not accompanied by an expectation that the information is correct or valid.  The “free flow” folks would argue that it is not our role as scientists or doctors to validate the information that is available, but rather to trust the universe of people who access the information to validate it on their own terms.  In other words, it is the exposure to the information that is important, not its validity.

 

Within this free flow of information, there still have to be arbiters that commit themselves as individuals or organizations to present the information as accurately as possible.  Scientific information is complex enough for those of us who deal with it every day, let alone most people who are not familiar with statistics or the scientific process.

 

And that brings me back to the role of the American Cancer Society.  We have invested significantly in information related activities.  This investment takes a number of forms, including: brochures; a website that is loaded with useful information for the public and medical professionals; a 24/7/365 call center that is staffed by highly trained and experienced cancer information specialists who can answer (or find the answer) to almost any question related to cancer and its treatment, as well as prevention and early detection; a corporate communications department that works regularly with the media to provide accurate interpretations of current research reports; and volunteers and staff experts who provide background information to many people who have questions on a specific issue related to cancer.

 

But there is more to this information story, such as how the Society impacts the dissemination of research into clinical practice, as I noted at the beginning of this blog entry.  Or, how we incorporate scientific information into our everyday organizational activities.

 

This is a bit more complicated.  There is a number that circulates in the medical community which states that it takes 17 years for a scientific development to impact medical practice on a widespread basis.

 

17 years is a long time, as we all acknowledge.  And with the volume of scientific research increasing, along with the number of reports of that research growing rapidly, you can probably appreciate the task at hand.

 

How does one evaluate research for its potential impact on the treatment of patients?  In truth, there is no judge or panel of experts who make such decisions.  It is more reliant on a “natural” process that assimilates the information and either decides that it is not relevant, or can move it along in some deliberative, natural evolution to get to the point where your doctor may use it in her/his everyday activity.  This is the “17 years” I referred to above.

 

This conservatism usually has some value, because it means that every time some expert says their research is the “new standard of care,” there are many others who need to be convinced of that.  More often than not, in my opinion, that is a good thing.  I have seen too many “breakthroughs” result in serious problems that could have been avoided by a more thorough vetting process, or eventually be proven not to have been as valuable as originally thought.

 

On the other hand, we shouldn’t ignore other research that really does have (and should have) an immediate impact on how we practice medicine.  The recent research regarding the value of Herceptin in the adjuvant treatment of women with HER2 positive breast cancer is a good example.  Gleevec in the treatment of chronic myelogenous leukemia is another.  In general, these types of breakthroughs deserve immediate dissemination and implementation in everyday practice.  But those events are the exception rather than the rule.

 

The conclusion is that when the research is strong enough and compelling enough, the information will move quickly to promptly and dramatically affect the standard of care for patients with cancer and other diseases.  The information quickly passes the “muster” of the scientific and medical communities, and is rapidly disseminated to the public in a variety of ways including through the information activities of the Society, the media, and others.

 

There is a lot more to this story, in particular how the Society uses information to guide its processes, and how we help others understand information and scientific reports.  I plan on continuing this discussion in my next posting.

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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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