There are some things that are hard to believe, like a prediction that Martians will land in Atlanta tomorrow.

Even harder to accept is the fact that some folks, including people in positions of substantial responsibility--such as mayors, governors and other politicians—don’t believe that exposure to second-hand smoke is harmful.

It is, and the evidence is very clear that exposure to second-hand smoke causes illness and death. 

Despite all of that evidence, we still seem to have barriers put into place which prevent us from enacting laws which would protect those of us who are non-smokers (and I would also include former smokers) from the harmful effects of environmental tobacco smoke.

One of the remaining issues regarding the harms of second-hand smoke has been the question of how much lung cancer risk exists for non-smokers who are exposed to second-hand smoke in the workplace.

A study reported today in the American Journal of Public Health answers that question, and takes us one step closer to understanding how dangerous second-hand smoke can be.

As the authors point out, most research on the topic of second-hand smoke and the risk of developing lung cancer have been done with the non-smoking spouses of smokers.

Where we don’t have a clear picture is the lung cancer risk you face if you are a non-smoker and work in a place that permits smoking.  For many folks, that means in restaurants and bars, and casinos among other locations.

To answer this question, the researchers examined a number of scientific papers published on the topic of lung cancer risk and second-hand smoke in the workplace.

They took the information from those papers and pooled the numbers so they could get an idea of whether or not non-smoking workers in those workplaces faced an increased risk of getting lung cancer.

The answer simply stated was, “Yes.”

When combining all of the papers and all of the people studied as part of those 22 reports, the researchers found there was a 24% increased risk of developing lung cancer in non-smoking employees who were exposed to second-hand smoke in the workplace.

However, they also noted that if you were a worker considered to be “highly exposed” to environmental tobacco smoke at work, then your risk of getting lung cancer was doubled compared to people who did not smoke.

That may not seem like much.  After all, we know that almost all lung cancers are related to cigarette smoking.  About 10%-15% of lung cancers occur in people who don’t smoke.

The chances of any one man getting lung cancer during his lifetime are 1 in 12, and for women the risk is 1 in 16.

If you are a non-smoker, your odds of getting lung cancer are much less than that. 

But, if you work in a smoky bar for a length of time, and you don’t smoke yourself, then your chances of getting lung cancer increase significantly according to this study.

The reason this is such a problem, as pointed out in the article, is that many folks—even today—work in smoky places.  That means that many folks are at risk are at unnecessary risk of getting lung cancer. 

Let’s not forget that a diagnosis of lung cancer is no minor issue.  Most of the folks with this disease are diagnosed at late stages, and frequently the disease is fatal.

Lung cancer screening with CT scans—for which the jury is still out for most smokers and former smokers—isn’t even on the radar for people who are non-smokers.  That translates into no early signs, no early symptoms, and a poor prognosis once diagnosed.

As pointed out in the article, there is a long list of distinguished organizations that all agree on one thing: second-hand smoke causes cancer in people.

The list includes, among others, the Surgeon General, the National Institute for Occupational Safety and Health, the US Environmental Protection Agency and the International Agency for Research on Cancer.

The American Cancer Society certainly believes that second-hand smoke causes lung cancer, and has worked hard for the passage of strong smoke-free laws nationwide.

Today, 21 states, the District of Columbia and more than 2500 communities have smoke-free laws in place.

That means that 52.9% of the population in the United States is now protected from second-hand smoke.

According to my American Cancer Society colleagues, all top 10 tourist destinations in the United States have some form of smoke-free law. 

However, as I reported recently in my blog, I am not certain that Las Vegas—which certainly fits into the Top 10 category-- will solve its problems since their smoke-free ordinance exempts casino floors.  (The experience of my physician colleagues at a November meeting of the American Medical Association in Las Vegas was so bad that we voted never to have a meeting in a smoky hotel ever again.)

The impact of smoke-free laws has been studied extensively, especially in New York which had the guts to go smoke-free in the face of significant opposition, and made it work.  New York serves as an example to any community in this country which thinks people won’t support a decision to create a healthy indoor environment.

By many measures—including economic ones—the decision by New York to go smoke-free was a huge success. 

In fact, as a result, the New York State Department of Health estimates that there are 140,000 fewer smokers in New York today than when the regulation was enacted in 2003.

In June 2006, the Surgeon General produced a report which provided overwhelming evidence that second-hand smoke is a danger to our health.

Beyond causing lung cancer, the Surgeon General noted that second-hand smoke “has immediate adverse effects on the cardiovascular system and causes coronary heart disease and lung cancer.”

He went on to conclude:

“The scientific evidence indicates that there is no risk-free level of exposure to second-hand smoke.

“Many millions of Americans, both children and adults, are still exposed to second-hand smoke in their homes and workplaces despite substantial progress in tobacco control.

“Eliminating smoking in indoor spaces fully protects nonsmokers from exposure to second-hand smoke.  Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot eliminate exposures of nonsmokers to second-hand smoke.”

Despite all that we know, there are still 126 million Americans who are non-smokers (many of whom are children) who are regularly exposed to second-hand smoke.

And so I conclude where I started: 

• What is it that our elected leaders don’t understand?  

• Why do they continue to pay homage to those who say it is their “right” to smoke? 

• Why are they so afraid that economies will suffer, when the evidence says that not only will businesses survive, but many have found their revenues increased?

It bears repeating that there are a lot of angry folks out there who agree with former Surgeon General C. Everett Koop, who said, “The right of smokers to smoke ends where their behavior affects the health and well-being of others.”

There is no “right” to smoke except in your own private space. 

There is no “right” to harm me and my family.

There is no “right” to risk the lives of your workers.

To me, the conclusion of this report is clear: no one should have to pay with their lives for the right to earn a living.

It is time for many parts of this country to take this message seriously, and do the right thing.

It was a small statistic in a straightforward report.  But its impact and implications are potentially huge:

From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4% to 74.6%, or 1.8%.

1.8% doesn’t seem like much, so why all the fuss?

Because in real terms, this means that thousands of women may have undetected breast cancer and will potentially miss the opportunity to save their lives.

This really wasn’t unexpected by those of us who try to keep up with current mammography practices.

My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography screening compliance.  We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer.

During the course of the past year, we have had discussions with several different groups, including insurers and quality assurance organizations, who were concerned about their own observations that mammography screening rates were dropping.

Then, at the San Antonio breast cancer conference in December, there was a stunning report that from 2002 to 2003 the number of new breast cancer cases diagnosed in the United States had actually decreased 7% (For my comments on this study, please see my blog entry for December 15.)

How does all of this fit together?

We have been making considerable progress in reducing deaths from breast cancer, despite what has been up until recently a continuing increase in the number of women diagnosed with this disease.  More recently, the American Cancer Society has reported that the number of new cases diagnosed in year to year comparisons has actually appeared to be leveling off, the San Antonio report of a large decrease notwithstanding.

But what will happen in the future with respect to deaths from breast cancer, if the trend detected by the CDC continues, is a source of great concern. 

We know that annual mammograms for women at risk for breast cancer significantly decrease deaths from this disease.

As I have mentioned in other blogs, none of the advances we have made in the treatment of breast cancer even begin to have value in the treatment of a woman’s breast cancer unless she starts by taking care of herself and getting a mammogram every year.

As a result of the widespread availability and uptake of mammography in the United States, we have been able to increase survival from breast cancer.  Today, for a woman whose breast cancer is found early and has not spread to regional lymph nodes, the five year survival is 98%.

Let’s take a quick look at some numbers.  These are just estimates for discussion purposes, but they at least will give you some perspective on the problem.

My colleagues tell me there are approximately 80 million women in the United States who should be getting a mammogram every year as recommended by the American Cancer Society.

But of those 80 million women, not all get an annual mammogram.  In fact, we estimate that about 60% of women currently follow that recommendation (the CDC study looked at women getting a mammogram within the previous two years, which is why their numbers are higher than ours).

So, if there is a decrease in mammography compliance (as measured by the CDC standards), that would mean about 1.44 million fewer eligible women had a mammogram in 2005 compared to 2000.

Now, let’s take the next important step in this analysis.

My colleagues also tell me that the rate of breast cancer found on mammograms is about 4 to 6 per 1,000 mammograms per year. 

If 1.44 million fewer women had mammograms, that translates into about (and these are very, very rough estimates) 5760 to 8640 women having a breast cancer that was not found in 2005.

Read that sentence again carefully:  thousands of women have undiagnosed breast cancer that would likely have been found if they had a mammogram in 2005, as compared to 2000. 

(Of course, we can’t forget that based on the CDC survey there are still another 20 million women who aren’t getting mammograms, and within that group there are many more thousands of women with undiagnosed breast cancer.  But here we are trying to put into perspective only the impact of the decline in mammography.)

These aren’t breast cancers that don’t exist.  These are breast cancers that exist and are not being diagnosed.

Why are we seeing this decline?  Frankly, we don’t have all of the answers.

We know that the number of doctors specializing in mammography is declining.  

We know that in some areas of this country women are having problems getting access to mammograms in a timely manner. 

We know that women who don’t have health insurance or are less educated have a lower rate of mammography.

When the large decline in breast cancer incidence from 2002 to 2003 was reported in December, there was much speculation by experts interviewed in the media that this was due to the fact that women discontinued hormone replacement therapy as a result of a report in July 2002.

My own opinion, as I expressed in my blog entry at the time, was that although this may have had some impact, it wasn’t logical to assume that every woman stopped her hormones right after the article was published, and that breast cancers stopped occurring.

I thought that, although the decrease in HRT may have had something to do with declining diagnosis, there were likely additional explanations, including a decrease in the growth rate of some already-existing cancers. 

And, I noted, declining mammography utilization was quite possibly one of those reasons.

So what is going to happen as a result of the observations in this current CDC report?

First, and most concerning, is that this may be just the tip of the iceberg and that this may be a very unwelcome trend.  In a sense, these numbers may be the canary in the coal mine.  We will certainly want to follow this very carefully.

Next, we need to understand exactly what is behind this decline.  Is it limited to certain groups of women?  The need to know why this is occurring is critical to our understanding of what we need to do to fix the problem.

For example, we know that only 1 in 5 eligible women in this country are able to take advantage of the CDC’s National Breast and Cervical Cancer Early Detection Program, which provides access to mammography and cervical cancer screening for underserved women.  This program has proven its effectiveness, and it saves lives but it is underfunded and underutilized.

One of the issues that has not been talked about frequently is the possibility of compliance fatigue.

I have observed among my doctor colleagues that they are not doing all they could to see that their patients get recommended screening and prevention studies.  After all, they have a lot on their plates, and prevention has a tendency to fall to the bottom of the priority scale in our current health care system.  It is hard for docs to quantify the benefit to society of the screening recommendations they make to their patients.

Well, if that is happening to doctors, why would we think it couldn’t happen to patients as well?

Women who are 60 or 70 today and have been compliant with screening recommendations have been getting a mammogram every one or two years since the 1990’s or perhaps earlier.  After a while, it would seem logical to most people that you just don’t have to go every year.  It is inconvenient to go to the doctor’s office, and a mammogram is not the most fun thing a woman can do with her spare time.

But that is a dangerous assumption.  Breast cancer is a disease of aging, and the risk increases as you age.  So if you think you don’t have to go because the last 20 studies have been fine, you are misleading yourself when it comes to your risk of breast cancer.

Mammograms don’t prevent breast cancer—they find it early in most cases.  So, the more mammograms you have doesn’t mean you are at less risk of finding breast cancer on the next study as you get older. (I am assuming for this comment that a woman goes every year, as opposed to a woman who goes every 5 years, for example.)

A comment on my blog from a breast cancer survivor noted that she was concerned that women were becoming complacent about getting a mammogram because they stopped their hormone therapy.

First, let’s point out that the increased risk of breast cancer was found with combination hormones and not so much with estrogen alone.

Second, the risk of breast cancer for the average woman is only slightly increased because of the hormones.  Almost all of the risk of getting breast cancer for any one woman is simply due to the fact she is a woman, and is getting older (assuming there is no significant family or genetic history).

And then there is the final issue that needs to be addressed:  Is all of the publicity that has questioned the value of mammography having a negative impact on the behavior of women?

Study after study has demonstrated the value of mammography.  We have seen declines in death rates from breast cancer, in no small part due to the contributions of mammography.  The American Cancer Society stands behind its firm recommendation that women need to get mammograms.

But we also know that when the public message gets muddled, people react by ignoring the recommendations.  That is one of the problems we face in public health.

Despite very clear recommendations by many authoritative organizations, the negative publicity in the recent past may have confused the public and contributed to complacency.

If that’s the case, that is unfortunate because women will pay with their lives.

Going forward, as I mentioned above, these breast cancers are not going to go away.   They will continue to grow, and they will eventually be diagnosed.

But I for one would hate to see us slide back to the good old days when almost every breast cancer patient I saw in my practice found their cancer by feeling it in their breast.

Those good old days were associated with larger cancers that spread into the lymph nodes and not infrequently into other parts of the body.  They were beyond hope of cure, or certainly at greater risk of recurrence following diagnosis.

That is one part of the good old days that I would like to leave behind.

But if we continue to see fewer women getting mammograms, then it is inevitable that we will see the tides turn in the wrong direction.

That won’t be evident for several years, but it is likely going to happen unless we reverse this trend.

And that would be tragic.

Last February I wrote a blog about the decrease in the number of people dying from cancer in the United States from 2002 to 2003.

This was the first time since records have been kept that such a decline was ever seen, despite the fact that we have a population in this country that is growing and becoming older.

One of my conclusions from that posting was the following:

 “Probably the most important ‘next question’ is whether we believe this decline in the number of cancer deaths will continue.  The obvious answer is that we hope so.  The honest answer is we don’t know.”

Now we do know the answer to that question, and we can say with certainty that, for the second consecutive year, the absolute number of people dying from cancer in this country has continued to decrease.

And, my friends, that is wonderful news.

Every year the American Cancer Society publishes an article titled “Cancer Statistics.”  

In that publication, we do two things:

First, we estimate what the number of new cancer cases and cancer deaths will be in the United States for the coming year using sophisticated statistical models.  You frequently see that information quoted in the media as, “The American Cancer Society estimates that “x” number of cases of a particular cancer will occur in the United States this year.”

The other part of the annual report is to provide an update on the actual number of cancer deaths that occurred for the latest year when the information is available for analysis.  That data usually lags several years because of the need to collect accurate statistics.

Last year in our Cancer Facts and Figures 2006 report, we announced there were 369 fewer deaths from cancer in 2003 than 2002.  Most of this was due to fewer deaths in men; there actually had been an increase in the number of women who died from cancer.

This year, when the data from 2004 and 2003 were analyzed, we found there was a decrease of 3,014 deaths from cancer in 2004 compared to the previous year.  This included 1,160 fewer deaths in men, and 1,854 fewer deaths in women.

The authors of the report also noted that the largest change in the number of deaths was from colorectal cancer, decreasing by 1,110 in men and 1,094 in women.  Also contributing to the decline was a decrease of 333 deaths from lung cancer in men, 666 breast cancer deaths in women, and 552 deaths from prostate cancer in men.

When the authors of the article looked to see which cancers showed the greatest decline in death rates from 1990 to 2003, they found that for men most of the decrease was in lung cancer (down 38.4%), prostate cancer (down 24.8%) and colorectal cancer (down 16.1%).

For women, the greatest decline in death rates from cancer was in breast cancer (down 39.4%) and colorectal cancer (down 22.3%).

Unfortunately, not all of the news is good.

Although many cancers death rates in men and women have been declining from 1990 to 2003, there are some that are increasing, including primarily cancers of the esophagus, liver and bile ducts in men (accounting for about 75% of the increase in men), and lung cancer in women (accounting for about 86% of the increase in women).

If there is any good news about lung cancer and women, it is that the death rates appear to be leveling off and hopefully will begin to decline within the next several years as women start catching up to the significant decreases in lung cancer death rates that men began to experience in the 1990’s.

No doubt, we still have a long way to go.

There will be an estimated 1.44 million new cases of cancer diagnosed in this country in 2007.  And that doesn’t include the more than 1 million new cases of “benign” squamous and basal cell cancers of the skin, or the estimated 62,030 “in situ” (non-invasive) cases of breast cancer in women, or the 48,290 “in situ” cases of melanoma.

And, despite our progress, an estimated 559,650 Americans will lose their lives to cancer in 2007, which is over 1500 deaths every day of the year.

Common cancers are still common: 

• In men, prostate cancer alone will account for 29% of new cancer cases, lung cancer 15% and colorectal cancer 10% in 2007.

• For women, breast cancer will represent 26% of new cancer cases, lung cancer 15%, and colorectal cancer 11% this year.

• Many women are not aware that lung cancer is the leading cause of death for women in this country, accounting for 26% of cancer deaths.  In contrast, but still too high, breast cancer is responsible for 15% of cancer deaths in women, followed by colorectal cancer with 10% of all cancer deaths in women.

Cancer still remains—unfortunately—the leading cause of death in this country of people under the age of 85.  In that group, approximately 59,000 more people died in this country from cancer than heart disease in 2003.

And the news is not acceptable when we consider race and ethnicity as the defining factor.

The report indicates that for all cancer sites combined, African American men have a 15% higher incidence rate and a 38% higher death rate compared to white men.

African American women actually have a 9% lower incidence rate of cancer compared to white women, but their death rate is 18% higher for all cancer sites combined, according to the study.

Although there may be a number of factors that explain these sad differences, the reality is that access to screening and access to timely diagnosis and treatment for many cancers for African Americans in this country is thought to be responsible for much of the discrepancy.

What we do know is that, for several cancers that have been studied, equal access means equal outcome.

As our population in the United States becomes more diverse, there can be little question but that we must address these issues directly.  To not do so may mean that, at some time in the not too distant future, we will inevitably see cancer deaths resume climbing.

My conclusions this year are not that dissimilar to my comments last year:

• We have seen a significant decline in the number of cancer deaths in this country for the second consecutive year.  Although we hope that this decline will continue (and possibly accelerate) in future years, we can’t be certain until the data is available.

• Much of that decline is due to better screening and better treatment, as well as a decrease in the number of people who smoke.

• We still have much we could do to improve these successes, as reflected in the decline in the number of colorectal cancer deaths.  Many people who need to be screened for cancer, whether it be mammography, cervical cancer screening or colorectal cancer screening, for example, either aren’t taking advantage of the opportunity or don’t have the opportunity.  We need to do better.

• We must solve the access issue.  We spend over $2 trillion dollars on health care in this country every year, and yet lives are being lost for the most simple and basic lack of medical care.  For example, can we take pride in our health care delivery system when only 1 in 5 eligible women are able to take advantage of the CDC sponsored breast and cervical cancer early detection program for women who lack adequate access to cancer screening, a program that has been shown to save lives?

So, while we congratulate ourselves on our successes, we must not ignore our inadequacies.  If anything, we must take note of those problems and redouble our efforts.

This is a journey of sometimes small and sometimes simple steps.

Our research moves forward, developing better understanding of cancer and what we can do to improve our ability to prevent, detect, and treat the many diseases that we call cancer.  However, much of our success will be in a succession of small steps, and not huge breakthroughs (although, fortunately, those do happen from time to time).

Simple steps include what you can do for yourself, your family and your community by following straightforward recommendations about nutrition, physical activity, smoking and screening, and by making our environments safe through such actions as eliminating second hand smoke.

We must understand that only through our control of our health, through our investment in research, and through making access to medical care a priority for our nation will we be able to make this successful report on decreasing deaths from cancer in this country an annual event.

I want to follow-up on the blog I posted earlier today about the Erbitux announcement.

No, I haven’t heard from the company, so there is no further information to report as to the effectiveness of Erbitux in the “first line” treatment of patients with advanced colorectal cancer.

What is interesting is that I am not the only one having some difficulty today about how companies report the information from their clinical trials.

This afternoon the New England Journal of Medicine published two studies on new drugs for the treatment of advanced renal cell carcinoma (kidney cancer). 

These reports reviewed two clinical trials for two different targeted therapies, sorafenib and sunitinib.

In both cases, these drugs delayed the time it took for the kidney cancer to progress.

The sorafenib studies had been completed in early 2005, and in December 2005 the drug was approved by the FDA for the treatment of advanced kidney cancer.

The sunitinib data was presented at the ASCO annual meeting in June 2006.

One of these papers almost did not get published in the New England Journal, which is considered one of the premier—if not the premier—medical journals because the drug company which sponsored the study did not comply with open disclosure requirements.

In an editorial written by the editors of the Journal, they point out that it wasn’t the scientific quality of the paper on sunitinib that led to its initial rejection by the Journal. 

It was the fact that the trial had not been registered for public disclosure and review. 

That is a no-no among certain medical journals that have agreed to follow standard procedures, including requiring clinical trials to be publicly registered in advance, if the results of those trials were eventually to be considered for publication in those particular journals.

The editors noted that the drug company which had sponsored the trial stated the following on their trial registration form:

“Primary (Secondary) outcome information was omitted due to [its] commercial sensitivity and will be revealed at a later date.”

Fortunately for the study authors, another investigator had in fact registered all of the appropriate information in a public clinical trials database, so the paper was accepted for publication after all.

The editors conclude, “Before you enroll a patient in a study, be sure that there is a full and appropriate registration of the trial in a public database approved by the ICMJE…It could salvage a study report that otherwise would not be published.”

Why is this registration so important?

Until recently, there was no required public record of clinical trials.  And, there is still no requirement that such trials be registered.

As a result, there is no audit trail that would allow someone to find out the results of a privately financed clinical trial, if the sponsor of that trial did not want the results released. 

That is one of the reasons a number of leading medical journals got together and made the decision to require public registration of the trial if the results were eventually going to be published in one of their journals.

This would allow the public to know about the trial, the design of the trial and the planned outcomes of the trial.

And, if someone decided to “bury” a trial, there would be a public record that the results of the trial had not been reported.

So here we are, today, getting a taste of how the results of new medical interventions and innovations are disseminated.

In one example, as noted in my earlier blog, a clinical trial was done and a “teaser” provided to the public (and investors) that this drug was effective as an initial treatment of advanced colorectal cancer.  Nothing further was (officially) provided.

In the other example, a company had declined to provide the end points of their trial, and that would have prevented maximum dissemination of the results of the clinical trial in a respected medical journal, but for the “mistake” of another investigator.  (In fairness, the editors point out that the particular company in question has improved its behavior considerably, and since 2006 has registered almost all of its trials, providing complete information.)

Again, there are no simple answers to these dilemmas. 

But these examples point out that our ethical responsibility is to be certain that people get accurate information and full disclosure in a timely fashion, and not at the expense of their emotions or their lives.

How pharmaceutical companies and the media handle stories of importance to cancer patients can have great impact, particularly on the emotions and decisions that patients and their families face when trying to make a decision on what is the best treatment is for their particular illness.

Imagine my surprise today when I heard a headline on a national TV show this morning that one of the newer targeted therapy drugs had proven effective in the treatment of metastatic colorectal cancer, and I couldn’t get the facts behind the news.

Colorectal cancer is one the common forms of cancer in the United States.

In 2006, the American Cancer Society estimated that 148,610 people will be diagnosed with colorectal cancer in the United States, and 55170 people would die from this disease (updated estimates for 2007 will be released on January 19).

Of those diagnosed between 1995 and 2002, according to the SEER database, 39% will have disease confined to the colon, 37% will have regional disease (meaning the cancer will have spread to the lymph nodes), and 19% will have distant (or metastatic) disease that has spread beyond the lymph nodes (the remaining 5% did not have staging information in the database).

When the disease has spread beyond the colon, the odds of surviving decrease.  When colorectal cancer spreads to distant organs, according to SEER data for 1988-2002, the five year survival is 9.1% for patients who are diagnosed with distant disease.

So, it is no small matter to folks either diagnosed with metastatic disease or who develop distant disease after their primary treatment as to what is the best treatment option for them when they receive this difficult news from their doctors.

Human nature suggests that patients, families and doctors alike are all very interested in knowing the latest treatment advances, and whether a particular treatment is better than another one.

There is a process that is generally followed in medicine that allows the profession to learn the latest information about a particular treatment, provides the profession the opportunity to evaluate the quality of the information, and then act on the results when it comes to the care of a particular patient.

In cancer treatment, many of these clinical trial results with new drugs or new approaches to the treatment of cancer are presented at the annual meeting of the American Society of Clinical Oncology. 

Held in various cities in late May or early June, this meeting provides many of the “breakthrough” reports in cancer treatment that have become part of the oncology landscape over the past several years.

For example, a couple of years ago, there were several reports on the effectiveness of Herceptin in the treatment of certain women with a more aggressive form of breast cancer.

The results of those studies showed that the use of Herceptin as an adjuvant—or preventive—therapy in the treatment of these women with breast cancer decreased the relapse rate from their disease, and significantly increased their survival. 

As noted previously in this blog, these presentations changed the standard of care for the treatment of about 20% of the women diagnosed with breast cancer overnight, at least in the United States.

The results of these studies were eventually published in medical journals, including the New England Journal of Medicine and more recently in The Lancet (direct link to abstract is not generally available. The article information for the Lancet: Vol. 369, Issue 9555, 06 January 2007, Pages 29-36).

Another example was the initial presentation of data on the value of Avastin (bevacizumab) in the treatment of patients with metastatic colorectal cancer at an ASCO meeting in 2003, which subsequently led to approval of the drug for the treatment of this illness.

In that circumstance, the data was clear-cut and compelling, and doctors once again had the opportunity to listen to the information, analyze the data, and make an informed decision as to what to recommend to their patients.

In fact, one of the problems that ASCO has faced in the past is the preliminary release of information from abstracts to be presented at their meeting, insofar as the abstract book is published and distributed to members and attendees prior to the meeting. 

It is one thing to print an abstract.  It is quite another to stand up in front of your peers and present your findings, knowing that if you overstate or misrepresent your data someone in the audience will almost inevitably stand up and challenge you.

Despite that risk of premature distribution of abstracts, there has been no news coverage of presentations (for the most part) prior to the embargo date for a particular presentation.

Now we come to today’s news.

The core of the press release is so brief that I will copy it here (you should review the entire release if you are interested, which contains a number of comments about the current medical indications for the drug, the side effects, a comment about colorectal cancer, and information about the companies that distribute the drug):

That’s it.  No abstract, no published paper, and as I write this, no additional information available from the company.

There are over 60 articles that have appeared so far today according to Google—primarily in the business press—that discuss this news release.  Several of them are longer than the press release copied above.  None have additional information about the study—how much disease free survival increased, how much longer the patients lived, or how toxic the therapy was for those patients who received it.

Nada. Nothing. Zero.

So here I am, a doctor who wants to know the substance of the information, who wants to be able to counsel patients on what to do.  After all, if this drug provides a meaningful increase in survival for patients with metastatic colorectal cancer, I want to know that.

For patients, they don’t have time to wait to find out.  They need to know now.

I have that information for Avastin.  I don’t have it for Erbitux.

The other factor at work here is that, even though the drug is not FDA approved for the “first line” treatment of metastatic colorectal cancer (except for a very limited number of patients who meet certain conditions), it can still be used “off-label” by oncologists for initial treatment (although reimbursement from insurance companies may be problematic). 

But such a decision should be based on facts, not guesswork.

I think you can get the drift of my thoughts:

Without having all of the information, what are patients and physicians supposed to do? 

If there was a huge breakthrough here, we need to know that, and we need to know that now.

You might argue that these companies, since they are public companies, must release information as soon as it is available.  But it should be noted this is a financial disclosure requirement, not a medical one.

And, you might add, the medical review system is set up in such a way as to disadvantage patients when a successful new treatment becomes available.

If you read the press release carefully, you will see the comment that the study results “have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.” 

That is almost 5 months from today.

If you are a patient, and you asked me today what you should do, I would have to tell you that I honestly don’t know.   And I am very uncomfortable in having to tell you that.

I am not impugning these companies for making this announcement, since I am not privy to their reasons as to why they did this today, instead of waiting for the presentation at ASCO—assuming the abstract will be accepted (which is probably a reasonable expectation).

I have called one of the companies to get more data, but was told that the information they could provide was limited to the information in the press release.  Their representative did say that they were going to try to get me more information if that was possible, and when they provide that to me I will post that information on this blog.

I am trying to point out what I think is the logical question, which is that information which provides hope without substance is more than problematic for patients with cancer and the doctors who treat them. 

It is, after all, about their lives and their survival.

We need a better process than what has happened here today.

How many times have you or someone you know complained about the time you spend in the doctor’s office waiting for an appointment or a test of some sort?

There are even folks who let it be known that their time is valuable, too—and if the doctor can’t keep the appointment on time, maybe they (the patient) should send the doctor a bill for their wasted time in the office.

An article in this week’s Journal of the National Cancer Institute takes that concept one step further, and shows that for cancer patients, at least, the time spent in the doctor’s office, the hospital, and getting to and from various appointments has real value. 

In fact, the article suggests that if we invested more effort in finding cancers early and developing better treatments for cancers, more people would be able to spend more of their time doing what they would rather be doing that having to sit in an office or lying in a hospital bed getting medical care.

With an expanding array of drugs and other treatments for cancer, there is no question that the cost of cancer care is becoming incredibly expensive.  With some of the newer drug treatments which are so expensive, patients and families are having detailed discussions whether the cost of taking the drug is worth the few extra months these drugs provide.

Health care economists and researchers have, for some time, used a calculation to determine whether or not a particular treatment or intervention is in fact beneficial for patients on a cost basis.  They have arrived at a number which they apply to certain treatments, and if the treatment provides “value” according to this approach, then it is more readily acceptable to insurers and those who pay the medical bills.  If the treatment is too expensive by this guideline, then the payors are more likely to balk at covering the treatment.

But researchers have generally not given much thought to the other factors that merit consideration when talking about the economic impact of treatment for medical conditions, particularly treatments for cancer.

Among those factors are the “costs” the patient experiences to receive medical care, when they have to spend time in the doctor’s office or the radiology suite or the lab instead of, perhaps, working at their job or doing something with their friends and families that they would find of more value.

And then there are the “costs” incurred by caregivers, who are frequently the children of older folks, and who themselves have to take time off from work to take their parents to the doctor or the lab.

Including these factors in the “cost” of medical care would seem a reasonable thing to do, but the fact is it is not so simple to measure and most economists and health insurers would rather ignore the question.

The authors of the JNCI article did in fact undertake such a study, looking at the time costs for patients diagnosed with the 11 most common forms of cancer in the United States, including breast, colorectal, uterine, gastric, head and neck, lung, melanoma, ovarian, prostate, renal and bladder cancers.

They estimated the time patients took traveling to, waiting for, and receiving care for three periods of time after diagnosis, including the year after diagnosis, continuing care, and last year of life.  They studied patients age 65 and older, and looked at over 760,000 patients, measuring the number of doctor visits, the various tests they received, the treatments provided, and the time they spent in the hospital.

The researchers also compared these times with a control group that did not have cancer to determine the specific impact of time costs for patients with cancer compared to those who did not have cancer.

Admittedly, the comparisons the researchers were able to make were crude.  They selected arbitrary travel times, for example, and based the “hourly wage” on a fixed dollar amount of $15.23 per hour.

Nonetheless, they assembled a substantial amount of information that provides a reasonable insight into what the differences in time costs would be between different types of cancer.

So what did they find?

Some of the information may not surprise you.

Patients with colorectal cancer, gastric cancer, lung cancer and ovarian cancer had the longest hospital stays the first year after diagnosis; patients with melanoma, prostate cancer and breast cancer had the fewest days in the hospital.

For physician visits during the first year, patients with ovarian, lung, gastric and colorectal cancer had the most; patients with melanoma, prostate, bladder and uterine cancer had the fewest office visits.

In the last year of life, patients with gastric, lung, ovarian and renal cancers spent the most days in the hospital.  They also had the largest number of office visits with a doctor.

When the researchers looked at the number of hours cancer patients spent receiving and traveling to medical care compared with the control group that did not have cancer, they found the most time was spent by patients with gastric, lung, ovarian and colorectal cancer in the first year after diagnosis.  For patients with ovarian cancer, they spent a total of 410 hours receiving medical care, compared to the control group (without ovarian cancer) that spent 42.4 hours.

In their last year of life, patients with gastric, lung, ovarian and renal cancers spent the most time receiving medical care.  The largest number of hours spent in medical care for patients with gastric cancer was 614, and for the control group the number of hours was 102.

When you do the calculations, that means that gastric cancer patients in their last year of life spent 512 more hours receiving their medical care than patients without cancer.  That amounts to three weeks.  (In fact, the actual difference is probably much greater.  The researchers counted a hospital day for only 16 hours instead of 24, since theoretically 8 hours would be spent sleeping no matter what illness a patient had or didn’t have.  Since gastric cancer patients spent an average of 35 days in the hospital in their last year of life, that means there is an additional 280 hours not accounted for in the above calculation.  That translates into an additional 11.7 days.)

In all, when the total dollar value of the time spent traveling to and receiving care for cancer was determined, the researchers concluded that for the eleven most common cancers the value of the patients’ time was $2.28 billion for the first year after diagnosis,

What the study does not tell us is the time cost associated with the caregivers who provide assistance to these patients, and help them get to and from their doctor visits, treatments, and other tests that they require.

The study also did not include time spent in hospice or home health care.

In an editorial which accompanied this article, the authors of the editorial point out that patients with cancers which are generally found early—such as breast, uterine, melanoma, prostate and bladder cancer— and can be treated for cure, generally have less time spent receiving care.

By finding cancers early, patients can spend more of their valuable time doing what they want to do, rather than having to spend time receiving medical care.

But what was surprising was that this lower time spent receiving care carried over into the last year of life for reasons that are not certain. 

In other words, if patients with a particular cancer spent less time receiving care during the first year of diagnosis, it was likely that those same patients with those same cancers would also spend less time receiving care in their last year of life.

The editorial also points out that if we are able to develop more treatments—such as targeted therapies—that can be given with fewer visits to the doctor (such as to receive chemotherapy or get blood tests), then this has real value and should be considered in the cost calculations for treatment effectiveness.

In short, what may be a more expensive therapy at first glance could, when all costs are considered, in fact be a less expensive treatment in the long run.

As the editorial notes, “Treatments that reduce time costs while maintaining or improving efficacy should be encouraged.  Manufacturers of new cancer therapies that reduce patient time costs should quantify these benefits because they improve the value of the products.  Similarly, health insurers should consider rewarding manufacturers of therapies that reduce both direct medical and direct nonmedical costs, even though the latter do not enter in to their bottom line.”

It is unlikely that we will be able to get our arms around all of the direct and indirect costs of cancer treatment any time in the near future.

But that doesn’t mean we shouldn’t continue our efforts to understand all of the costs associated with cancer care, so that we can make the best decisions as to what works and what doesn’t work, and what we can afford and what we can’t afford.

We must never forget that patients want to live their lives, and that being able to live that life without having to spend time in a doctor’s office or a hospital bed has real personal and economic value