Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

The American Cancer Society

Happy Holidays--And Don't Forget Your Health

by Dr. Len December 22, 2007

I hope you are having a wonderful holiday season, enjoying shopping for gifts, visiting with friends and family, and making great resolutions and promises for the New Year.

 

What have I been doing?

 

My vacation started about a week ago.  But I don’t know that many people would envy what I did during the first week of my long awaited and much needed respite from my daily routine: I had a screening colonoscopy.

 

Yup, that’s right: a screening colonoscopy.

 

I write and lecture a lot about the importance of preventive medicine. 

 

I previously wrote a blog about my holiday experience two years ago, when I found out I had some fairly serious but common medical problems as a result of not following my own good medical advice.  My bottom line: I was stuck in “do as I say and not as I do.”

 

Two years later, fortunately all is much better and under control.  I made a commitment at that time to myself and my family to take care of myself, and I have done reasonably well—although like everyone else, I am certainly not perfect.

 

But my wife reminded me recently there were still some “unmet needs,” and colorectal cancer screening was at the top of the list (wives are like that from time to time).

 

So, being the good doctor that I try to be, two months ago I made an appointment with my friendly local gastroenterologist to get screened in December on the first day of my holiday vacation.

 

I can’t say that it was a fun way to start my “time off.”  I don’t know anyone who relishes the idea of having a long tube put you-know-where.

 

But it really wasn’t all that bad. 

 

The prep was much simpler than it was when I had my first screening ten years ago (however, I wouldn’t exactly say the liquid that I had to drink was particularly tasty).

 

The staff at our local hospital’s outpatient procedure area were exceptionally friendly and accommodating (I especially appreciated the warmed blankets they offered while I was waiting.  That was a very nice touch, I must say.).

 

The GI doc was also pleasant, especially when I volunteered the fact that I was very familiar with the procedure and the need to have it done.  It isn’t easy dealing with me at times, and this was definitely one of those times.

 

Then came the fun part—although I have no recollection whatsoever of the procedure.  A couple of milligrams of Versed and I was out like a light (although I understand that it was in fact a bit more than a couple of milligrams).

 

Maybe it’s a good thing I don’t remember, since I have had a couple of reports subsequently that I was a bit chatty during and after the procedure.

 

I guess the good news is that everything went well—including the finding of a small polyp which was benign.

 

And that brings me to the serious part of this discussion: why the American Cancer Society recommends screening for colorectal cancer in the first place.

 

Although I may sound like I am making “light” of a serious matter, the reality is that many people in this country—especially men—are reluctant to get screened for colorectal cancer.

 

The net result is that we have thousands of people dying every year whose lives may have been saved if they followed the Society’s screening recommendations for this disease.

 

You may choose to screen using other methods, including laboratory examinations to look for blood in the stool, or by having a sigmoidoscopy with annual stool tests.

 

But the end message is still the same: if you are 50 years of age and older, and at average risk of getting colorectal cancer, you need to be screened on a regular basis, consistent with the choice of test you select.  Remember, that the test you get is the best test for you.

 

This isn’t something you should put off for another day. 

 

Hearing that I had been screened, an acquaintance of my wife asked her to ask me to write about my experience in the hope that she could persuade her husband to be screened.

 

This couple had made an agreement with each other to get colonoscopies.  Apparently, she kept her part of the bargain.  The mistake, however, was that she didn’t make hubby go first.  He is now making excuses and hasn’t scheduled the test.

 

My mother had colon cancer at an advanced age.  That puts me at increased risk for this disease.

 

My first screening 10 years ago was negative.  This time, there was a very small polyp, and consistent with the American Cancer Society guidelines for follow-up, I will get screened again in five years.

 

No one can say for certain whether or not that little polyp would have grown to become something more serious, and turn into a cancer.  But now we do know for certain that it is gone and will not cause a problem.

 

Having endured the prep and the “event,” I can assure you that the piece of mind is worth far more than the inconvenience.  And, based on conversations I have had with many others, the odds are overwhelming that your experience will be similar to mine.

 

Taking some time to get some “preventive health maintainence” isn’t a bad idea for anyone.  Maybe you won’t take time from your holidays to go through a colonoscopy, but you can make a commitment and get an appointment now to do it early next year.

 

So my wish to you this season is that you have a wonderful holiday, and that you and yours have a happy, prosperous, and (especially) healthy New Year.

 

And, while you are out there spending money and spreading joy, take a moment to take care of yourself and your family.

 

That could turn out to be the greatest gift of all.

Health Insurance And Cancer: The Sad Reality

by Dr. Len December 21, 2007

An article published online yesterday in the American Cancer Society’s CA: A Journal for Clinicians  which reviews in detail the relationship between health insurance (or lack thereof) and cancer outcomes has received a good deal of press attention over the past 24 hours.

 

The article, written by my colleagues from our Department of Epidemiology and Surveillance Research here at the Society, is an in-depth review of published research which correlates the presence or absence of adequate health insurance with access to cancer care, cancer screening, and cancer outcomes.

 

On a logical basis, the conclusions are not surprising. 

 

As noted by the authors, “There is substantial evidence that lack of adequate health insurance coverage is associated with less access to care and poorer outcomes for cancer patients.  As our nation’s investments in cancer research provide greater understanding of how to prevent cancer, detect it early, and treat it effectively, access to health care becomes even more important to the American Cancer Society’s goal of eliminating cancer as a major public health problem.”

 

The statistics in the article are mind numbing in their detail.  They outline a system that is in fact a broken non-system of medical care, where those with adequate insurance and financial resources may wonder what the fuss is all about.

 

But if you take the time to read the article, you quickly see that we have serious problems in our health care system, particularly where it pertains to the early diagnosis and effective treatment of patients with cancer.

 

The authors acknowledge that “it is important to recognize that barriers to receipt of optimal cancer care are complex and involve patient-level, provider and health system factors.  Even among individuals with adequate health insurance, variation in receipt of optimal care and outcomes can be observed by race and ethnicity, sex, age, income, education, urban versus rural area of residence, and other sociodemographic and geographic factors.”

 

The authors actually provide an extensive and detailed description (with many accompanying statistics and references) which summarizes the various health insurance options available today in the United States.

 

They also provide considerable information on the strengths and weaknesses of each of these insurance options, such as what can happen when a person loses a job, divorces, or has a spouse die.  They also discuss the unfortunate reality that health insurance frequently is not adequate to provide effective coverage at times when people need it the most.

 

When it comes specifically to issues related to cancer, the authors point out clearly that health insurance relates to the probability of having a regular source of medical care, or medical home.  This factor correlates directly with the likelihood of having counseling regarding lifestyle factors which can reduce the risk of cancer, or having access to appropriate cancer screening for prevention and early detection, such as is the case with colorectal cancer screening and mammography.

 

Ultimately, it is the outcomes that count.  And this paper makes it very clear that no insurance or inadequate insurance or “too-late insurance,” such as the case for many people who receive Medicaid after their cancer is diagnosed, leads to later diagnosis and poorer survival.

 

I must admit that in this season of joy, happiness and optimism for a new year that reading this paper was exceptionally depressing. 

 

I began to wonder how anybody can effectively navigate the health care system when they needed care, if it is so complicated, so expensive and so non-responsive to those in need.

 

But the evidence takes us to where we need to be, and for many people in this country, according to this research, this is their grim reality.

 

An editorial which accompanies the paper, written by the new American Cancer Society president Elmer Huerta, MD, comments on the relationship between the facts presented in the paper described above and the Society’s current advertising campaign regarding access to health care.

 

Dr. Huerta has experienced first hand the problems faced by those without health insurance. 

 

He writes, “Some people will dispute or ignore these statistics, perhaps because of cognitive dissonance with their rosy internal image of health care in the United States.  One prevalent misconception is that only the poorest of the poor have trouble accessing health care and that even these poorest Americans can received high quality care (albeit with a little inconvenience) through hospital emergency departments and a patchwork of public and private safety-net programs.”

 

Dr. Huerta continues, “The truth is that there are gaping holes in our health care safety net and that most of these safety-net services are neither effective nor efficient in providing chronic-disease prevention, detection or treatment.  The truth is that our national reluctance to face these facts is condemning thousands of people to die from cancer each year and thousands more to die of other diseases.  And for those who are unmoved by this shameful injustice, the data also show that for many hard-working, middle-class families, a diagnosis of cancer sets in motion a series of unfortunate events, including job loss, los of employer-based insurance, bankruptcy, and all too often, premature death.”

 

In this time of the year, when so many of us focus on the blessings we have and the joy of our families, perhaps it isn’t asking too much to reflect on the results of this research, and the moving comments of Dr. Huerta.

 

As we make our rounds of buying and giving gifts, and celebrating the year past and the year to come, we must be mindful that there are those among us who will be facing a season of little joy because of events that are frequently beyond their control.  They may have lost a loved one to illness, or may be facing insurmountable medical debt, or can’t afford or gain access to adequate medical care at a time of need.

 

Somehow, that just doesn’t seem right, and maybe this is the best time to make a nationwide commitment to do something about it.

Avastin And Breast Cancer: It's Not Over Yet

by Dr. Len December 06, 2007

The decision yesterday by the FDA’s Oncology Drug Advisory Committee to recommend that Avastin (bevacizumab) not be approved for the treatment of metastatic breast cancer is one more step in a discussion that has significant implications not only for the use of Avastin in breast cancer, but also how this type of decision-making is going to influence cancer treatment in the future.

 

Avastin is a type of drug that we call “targeted therapy.”  These newer drugs generally target a specific process in a cancer cell that can then influence the function of the cell and lead to its death.  In the case of Avastin, the targets are the blood vessels that cancers need to grow.  Avastin interferes with that process, and has been demonstrated to be effective in a number of cancers, including colon and lung cancers.

 

In April, 2005, the National Cancer Institute announced that a clinical trial of Avastin with chemotherapy used in the treatment of women with recurrent breast cancer (compared to a “control” group that received only the chemotherapy) resulted in such positive results that the oversight committee monitoring the study ordered it to be stopped and the results released immediately.

 

This study showed that women who received the combination therapy extended the time for the cancer to progress by an average of four months, according to one news report.  The design of the study had anticipated about two months of improvement.

 

Although this increase sounds modest, the reality is that when applied to large numbers of women receiving treatment for recurrent breast cancer, the impact for some women can be far greater.

 

The results were so positive that the then director of the National Cancer Institute, Dr. Andrew von Eschenbach, called a news conference to be help disseminate the information as widely as possible.

 

The trial results were presented soon thereafter at the annual meeting of the American Society of Clinical Oncology, and expectations were high that Avastin would quickly be approved by the FDA.

 

But that was not to be.

 

In September 2006, the Food and Drug Administration asked for more information from the drug’s developer, Genentech, before the drug could be approved.

 

Then, yesterday, the FDA committee decided to recommend to the FDA that the drug not be approved for treating recurrent breast cancer.  The vote was close at 5-4.

 

Why the turnabout for a drug that held such promise for the treatment of an unfortunately common situation faced by breast cancer patients and their doctors?

 

The data presented to the committee apparently showed that for these patients, in this more current analysis, the drug delayed progression of their breast cancer by 5.5 months.  The women who took Avastin in addition to the chemotherapy went 11.3 months before their disease progressed compared to 5.8 months for women who took only the chemotherapy.

 

But the Avastin group also had more side effects, including 6 deaths attributed to Avastin treatment, or 1.7% of the women who participated in the study.

 

The key determining factor, according to press reports, was that the women who received Avastin did not live significantly longer than women who did not receive it.  And, this is considered an important statistic.

 

No prolonged survival, no approval.

 

Or will that be the eventual outcome?

 

The same Dr. von Eschenbach who held the news conference announcing the results of the trial in 2005 is the same doctor who now heads the FDA making the decision regarding approval.

 

To me, the more important question is whether a delay in progression-free-survival really has no value, even in the face of a small but definite risk of significant side effects?

 

Progression-free-survival is a very sterile, clinical way of saying that the patients’ breast cancers either regressed or at least stabilized.  And, the increase in this survival may have meant for many women that they remained more functional, and less symptomatic—with potentially less pain.

 

Personally, I am not so certain that an almost doubling in progression-free-survival with less pain should be ignored.   But the problem in this situation is that the researchers apparently didn’t measure this factor during the course of the study.  So, for all anyone knows, the patients may have lived longer, but their quality of life may or may not have been improved.  We have no evidence either way.

 

There is clearly a bias among doctors that if a cancer drug increases the time until the cancer recurs, that it is almost certainly associated with an improved quality of life.  And, I suspect, if that had been clearly been demonstrated, the drug would have been approved by the panel—the serious side effects notwithstanding.

 

But it wasn’t measured, and the vote was negative. 

 

The FDA has until late February to make a decision and I suspect that in this situation there is going to be a great deal of discussion within the agency as to whether or not they should follow the panel’s recommendation.

 

I think it is fair to say that doctors have been using Avastin to treat women with metastatic breast cancer since the first announcement in 2005.  This is what we call an “off label indication,” which means that there have been reports in the scientific literature that a drug is effective in a particular situation but hasn’t been approved by the FDA for that indication.

 

If the FDA doesn’t approve the drug, will off-label usage continue? 

 

I feel comfortable in predicting that insurers may well balk at paying for the drug under this scenario if the FDA looks at the evidence and decides not to approve Avastin for treatment of metastatic breast cancer.

 

In no small part, this decision will be driven by the high cost of the drug (tens of thousands of dollars) and the frequency with which it could be used.

 

And that has the potential to set off a cascade of events, likely even litigation, pitting patients and their doctors against the insurers and the government.  The heart of the argument will be whether a patient should be able to receive a drug that may improve the quality of their lives, even if there is no evidence that it may prolong their survival.

 

So, the end of the story has not been written and probably won’t be for some time.

 

In the meanwhile, there is likely to be intense discussion about how we got into the mess we are in, and what we need to do in the future to avoid repeating this scenario with other drugs and other clinical trials.

 

 

 

 

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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