A legend in life, a moment in death.  Such is the passing of Senator Edward Kennedy.

For many of us, this is not just the passing of a man.  It is the end of an era, and undoubtedly a new beginning.  This was the last survivor of a family that did not so much live out loud as it lived in view.  This was a family that knew unimaginable heights, yet suffered unspeakable losses.  And now the last is gone.

I don’t have personal recollections of the Senator.  Like you, I viewed him from afar.  But as I listened to the broadcasts this morning, it came to mind that he had been so many personae to so many people.  He was a champion, he was a legend, he was humane.  He was also frail, and he was human.  He achieved great things, and caused great sorrow.  But he also was offered forgiveness, found his way, and touched the lives of millions.  In a sense he was different from us while at the same time he was like so many of us.

To the health community, he was a champion. He was a politician to be certain, representing the interests of his constituents with vigor and passion.  But he was also known as a conciliator, someone who could reach out for solutions when reaching out was the right thing to do.

For the cancer community, he was a strong advocate.  He recently was honored by the American Cancer Society with our Medal of Honor and the National Distinguished Advocacy Award.  Not only did he honor our cause with his commitment and his efforts, he knew personally the travesties of the disease.  How sad that he lost his life in a battle that has been shared by so many, and for which he had tried to do so much.

There is no question but that his heart was in health care reform.  It was a longstanding dream for him, and he was indeed a champion for the hope that we could achieve access to quality care for all.  His loss has already been felt, and our prayer is that his legacy will bring reason and honor to the table to accomplish what so many believe is so necessary for the well-being of our country.

Life is to be lived, and passing is inevitable.  Our lives don’t follow straight and narrow paths, and who among us has not strayed from that path at some time in our journey?

To be noble is to never forget the errors of our ways, and to seek to do better.  We measure our present and our future against where we have been.  We must always strive to do more than we can, to be better than we have been.

In this light, we can be thankful for the life of Senator Kennedy. 

May God grant his family comfort in his memory in this moment of their loss.  May we celebrate the memory of this man for what he has done for the humanity of us all.

Once again, we have an example of when the news isn’t exactly news. 

A study reported today in the journal Cancer Research  says that treatment to prevent breast cancer recurrence with the drug tamoxifen  increases the risk of a woman developing a second, more aggressive of breast cancer in the opposite breast over 400%.

That’s the headline.  But the fact is we have basically known that since 2001, and frankly the way we treat women with breast cancer has changed considerably in between the two reports.  So the practical implications of the article aren’t new information, and the unfortunate unintended consequence is that many women with breast cancer may become unnecessarily alarmed.

Women with breast cancer are frequently put on preventive therapy to avoid a recurrence or spread of their cancer.  That treatment can include hormone-related medicines, such as tamoxifen or drugs called aromatase inhibitors, and may also include chemotherapy drugs which frequently have to be given intravenously.

We know these treatments—which may also include radiation therapy--are very effective in reducing the risk of cancer returning in the breast where it was diagnosed, as well as in the opposite breast and in more distant location.

In this current study, the researchers examined medical records of women diagnosed with breast cancer from the Seattle area between January 1990 and September 2005.  They looked for women who had or had not received preventive treatment with tamoxifen.  They spoke with many of those women, and examined their medical records to find out how long they had taken tamoxifen along with other information.  They then compared the histories of those women to others who also had breast cancer but had not received tamoxifen.

The goal of the study was to look at how often these women developed a second cancer in the opposite breast (women with cancer of one breast are at greater risk of developing a second cancer in the opposite breast), and whether or not that cancer was hormone sensitive (the cancer in the first breast had to be hormone sensitive, or otherwise the woman would not have been placed on taxmoxifen).

They found—as expected—that the women on taxmoxifen had a 40% decrease in the risk of developing a hormone-sensitive breast cancer in the opposite breast in they had taken tamoxifen for five or more years.  However, if the women took the tamoxifen for five years or more, then the researchers report that the risk of developing a second hormone-negative breast cancer—which is likely more aggressive than a hormone-sensitive breast cancer—increased 440%.

But here is where it gets tricky:

If you look at the number of cases of hormone-sensitive breast cancer avoided with tamoxifen compared to the increase in hormone-insensitive breast cancers, you find out the number avoided far outweighs the number increased.  And that doesn’t mean the women who developed these second cancers died from their disease.  It simply means those were the cancers diagnosed, and then treated.

And then there is the question of how precise and predictable the numbers really are.

Take that 440% number.  That means the women who took tamoxifen had 440% greater chance of developing a more aggressive, hormone insensitive tumor compared to women who did not take the drug.

But wait a moment…

In statistics, there is something we call the “confidence interval.”  In simple terms, it means if you kept repeating the same experiment in different populations or with more women in the same population, what is the chance you would come up with the same result?  What are the possible other numbers that may show up?

Sitting down?

In this study, the confidence intervals for that 440% number vary from 1.03 (a 3% increased risk) up to 19 (a 1900% risk).  In our world, that is what we call “not very tight.”  That 1.03 number—in reality—just gets you over the line of what we call statistical significance.

Much of this discussion would be academic if not for a couple of other issues.

First, this research was focused on women who were supposed to be post-menopausal, even though there were a number of subjects that were between 40 and 50.  In today’s practice, most of these women are not treated with tamoxifen.  Instead, they receive an aromatase inhibitor, and this study says nothing about their risk.  Most of the women who get preventive treatment with tamoxifen today are pre-menopausal breast cancer patients.

Secondly, this really isn’t new news.  It is a further refinement of a study previously reported—in 2001.  That study, which was written up on cancer .org when it was published had almost the exact same result, although at that time more women were being started on tamoxifen as a preventive treatment since we didn’t have as clear evidence that aromatase inhibitors were more effective in post-menopausal women.  In that study, the increased risk was 4.9 times greater for an ER negative tumor on women who had taken tamoxifen.

But I probably would have left this whole issue of “alarm” alone, were it not for a press release that promoted the study. 

Here’s the headline:

Long-term tamoxifen use increases risk of an aggressive, hard to treat type of second breast cancer

Study finds a more than four-fold increased risk of ER negative second cancers

Sounds pretty scary, but in fact it’s not new news.

The study is fine, and the results are what the results are.  But for women out there who are taking tamoxifen, it will inevitably cause them distress and panic and they certainly don’t need more of that.

Especially when we have played this song before.

By the way, here is what we recommended 8 years ago:

"Tamoxifen now has over 25 years of widespread use throughout the world, and it has clearly been documented as saving many, many thousands of lives from breast cancer," says Eyre (Dr. Harmon Eyre, our chief medical officer at the time). “Additionally, it has been documented to prevent many, many contralateral cancers of the breast in women who have had breast cancer, and it now prevents breast cancer in women who are at high risk from the disease," he emphasizes.

Patients and doctors will continue to benefit from using tamoxifen under appropriate circumstances, Eyre says, while exercising the cautions appropriate to a drug carrying some serious side effects.

"I believe that better drugs that have fewer side effects will eventually replace it," he suggests; "however, the use of tamoxifen should not be changed at the present time based on this one study."

And here is what my colleague Victor Vogel, MD, who is our National Vice President for Research—and is an expert on this issue—had to say today:

"The other very important point to make is that tamoxifen reduces the risk of recurrence in half, and also cuts the risk of dying by half among women who take it for only five years. That fact should not be lost: the benefits of tamoxifen among women who take it for five years are significant. Even if a woman were to take it for longer than five years and increase her risk of an ER-negative contralateral breast cancer, there would still be positive net benefit. Tamoxifen also reduces the risk of contralateral, ER-positive breast cancer by 50 percent, a fact that is not sufficiently emphasized in this article, in my opinion.

"So this study, while identifying a small risk only among women who take more than five years of therapy, does not sufficiently identify the benefits of taking up to five years of therapy. Women should not stop taking tamoxifen as a result of this study. Postmenopausal women should ask their doctors to switch them to an aromatase inhibitor (AI) if they are taking tamoxifen, and an AI should be used as first line therapy in postmenopausal women being treated for early breast cancer. Premenopausal women should still receive five years of tamoxifen and switch to an aromatase inhibitor when they are postmenopausal. These women will not be at increased risk for an ER-negative contralateral breast cancer."

It is time to move on.  And in the process, let’s not scare people with news that is not new.

Two articles and an editorial in the current issue of the Journal of the American Medical Association (JAMA) about the side effects and marketing of the cervical cancer vaccine are probably going to raise questions.  They may also fuel the fires of concerns among some groups that have raised thorny political questions about the vaccine, especially as to whether or not this vaccine should be mandatory for young girls.

The primary “scientific” report in JAMA describes the results of a post-marketing surveillance program that monitors the side effects of new vaccines. 

The study, written by researchers from the Centers for Disease Control and Prevention and the Food and Drug Administration is fairly straightforward. 

In order to monitor reports of subsequent adverse reactions, the CDC and the FDA sponsor an adverse event reporting system called the US Vaccine Adverse Event Reporting System (VAERS).  Anyone can submit a report of a suspected vaccine-related adverse event to this system, even if they are not the patient, a family member, a physician or other health care professional.  Once the vaccine has been in widespread use for a sufficient period of time, those reports can be evaluated and researchers can determine whether or not there are any unsuspected safety signals, or if certain adverse events occur more frequently than would have been anticipated based on the initial clinical trials.

More than 23 million doses of the cervical cancer vaccine had been distributed in the United States between the date it was approved in June 2006 and December 31, 2008.

During that period of time, the VAERS had received 12,424 reports of adverse events following vaccination with the HPV vaccine.  Most of the reports came from the manufacturer, but unfortunately those reports did not have patient information so they could not be verified.  Also, many of the reports included multiple adverse reactions in single patients.

The most common reactions were syncope (fainting) in 15% of the reports, followed by dizziness, nausea, headache and reactions at the injection site.

772 of the reports--or 6.2%--were considered “serious.”  These reports included 32 deaths.  There were eight reports of serious allergic reactions, nine episodes of blood clots (deep vein thrombophlebitis or DVT) 31 episodes of ascending paralysis (Guillain-Barre Syndrome, or GBS) in addition to spinal cord inflammation, pancreatitis, blood clots to the lungs, convulsions, allergic skin reactions, and autoimmune disorders.

There were 1896 reports of fainting, and 15% of those reports included a fall.  Of the people who fell, about 2/3 had a head injury as a result of the fall.

The researchers tried to verify many of the more serious events, but were stymied by the lack of medical information that was available.  In addition, a number of the reports of serious events were based on hearsay, where the person who reported the event did not have first hand knowledge of the reaction.

Obviously, the greatest concern is with the reports of 32 deaths that may have been associated with the vaccine.  Of those cases where data was available, there were several different causes of death including four that were unexplained. 

The authors conclude that the safety profile was in line with what would have been expected from the initial clinical trials of the vaccine.  They did point out, however, that there was a higher rate of syncope and blood clots (DVT) than was expected.  They also noted that surveillance is continuing.

Syncope after vaccination is not a new problem with vaccinations.  The authors note that fainting after a shot is not unusual in young people, especially young women between the ages of 11 and 18. They emphasized the need for patients, families, and health care professionals to follow recommended precautions after giving this vaccine, in order to prevent more serious injury.

The authors also noted that this reporting system is “passive.”  That means it relies on people letting the CDC and the FDA know about adverse events.  They also think publicity increased the number of adverse events that were reported since there were three times the number of reports for this vaccine compared to the rate seen for all other vaccines combined.

Their conclusion?

“The post licensure safety profile presented here is broadly consistent with safety data from pre-licensure trials.  Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and (adverse events), post licensure monitoring will continue and identified signals may be evaluated using epidemiologic observational studies.”

So that’s the science.  Now for the more controversial part of this report, which calls into question how this vaccine was marketed and what role medical associations may have played into misleading their physician members about the vaccine.

The authors of this article, from the Columbia College of Physicians and Surgeons in New York, refer to “critical and unresolved questions” about the vaccine in terms of how it was marketed, whether the vaccine was being targeted to those young women who need it most, and whether the medical societies were really unbiased in their presentations about the vaccine.

The authors maintain that by marketing this vaccine to prevent cervical cancer as opposed to preventing infection with a virus resulted in the vaccine gaining greater acceptance in the community and among physicians.  The authors claim that the public was led to believe that every young girl was at equal risk of getting cervical cancer, as opposed to focusing on young girls at greater risk of getting cervical cancer.  Those girls at risk are frequently economically and educationally disadvantaged which results in a lower likelihood that they will follow cervical cancer screening recommendations as they grow into adulthood.

To me, the most disconcerting allegations in this article are leveled at “professional medical associations” (PMAs) which are physician membership organizations that are highly regarded and have a significant nationwide presence.  The authors suggest that some of these organizations altered their professional focus and messaging surrounding cervical cancer as a result of corporate funding.  They established well-resourced speaker bureaus funded by the manufacturer to provide continuing medical education lectures, including carefully designed scripts and slides.  Even potentially controversial or difficult questions had very specific responses crafted as part of these kits. 

The authors conclude:

“As marketing of this HPV vaccine demonstrates, pharmaceutical company campaigns can undercut the most cost-effective and appropriate use of new agents to the detriment of adolescent health.  By making this vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored…Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor.”

These are serious comments. And don’t forget that they appear in JAMA, which is the medical journal published by the American Medical Association, the granddaddy of professional medical associations (although there is no suggestion that the AMA was engaged in any of these activities).

The editorial also discusses the complexity of decision making when it comes to evaluating the risks and benefits of a new medical treatment, such as the cervical cancer vaccine.  The writer points out persistent lack of knowledge about the vaccine, such as the impact on cervical cancer rates 20 or 40 years from now, and the fact that more long term studies about the vaccine were needed but have not yet been reported.

The opinion of the editorialist is bound to be the topic of discussion in the medical community:

“The net benefit of the HPV vaccine to a woman is uncertain.  Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened.  So rationally she should be willing to accept only a small risk of harmful effects from the vaccine. 

“When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit.  Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed.  The balance will also tilt if the adverse events are not calculated correctly.”

So what does the American Cancer Society recommend? 

Our guidelines call for routine vaccination of girls ages 11 and 12, and as young as 9.  We also recommend the vaccine for women ages 13 through 18 to “catch up” missed vaccines or to complete the series of three shots.  We do not believe there is sufficient evidence to recommend for or against routinely vaccinating women between the ages of 19 and 26, and those women should have an informed discussion with their health care professional about the benefits and risks of the vaccine.

All of this discussion led me to go back to our original guidelines publication.  We make every effort to have the best experts participate in our guidelines panels.  We do not take funding from industry to support our guidelines efforts, and we do not gain financially from producing our guidelines.  I do know that our panel spent countless hours reviewing the evidence, and discussing and debating many aspects of the HPV vaccine before they made their recommendations.

That said, I would be remiss if I didn’t note that a number of the experts on the panel do in fact have industry relationships related to the cervical cancer vaccine.  These are, after all, the experts that everyone seeks for their opinions.  I know many of them personally and by reputation, and all are highly regarded.  But as I noted in last week’s blog on whether or not physicians routinely recommend the vaccine, there are situations where I feel obligated to note potential conflicts, and this is one of those situations.

Ultimately, you will have to make your own decisions and conclusions about what all of this means—especially if you have a daughter who is eligible to receive the vaccine.  Far be it from me to tell you what to do, but I do continue to support our guideline recommendation. 

There is nothing in these articles that would make me change my mind.  Controversy is one thing, but good medicine is another.  And many experts I know and trust believe this vaccine continues to be “good medicine.”

The debate about euthanasia has gone too far.

Someone’s intent to do a good and necessary deed has now been transformed into a hideous misrepresentation that not only affects our humanity and dignity as a nation, but goes to the heart of the physician/patient relationship and the responsibility that physicians have to provide healing and comfort as well as treatment. 

That’s our oath, and that’s what we are supposed to do.  Recognizing that imperative is not something that should be punished as an evil act.

Perhaps some background would be helpful in framing the issue:

Medicare is supposed to only pay for medically necessary and effective care.  It is not allowed to provide other services such as screening or prevention unless specifically authorized by Congress.  End of life counseling falls under the category of non-covered services, but probably gets into the payment mix as part of other billing codes which doctors use to get paid for more routine “evaluation and management” services. 

Providing explicit payment for this service will encourage appropriate and needed discussions between physicians and patients on this very important, difficult and humanitarian topic.

For years, many of us have been concerned about end-of-life issues, such as living wills, pain management and hospice care.  Counseling our patients as they age about their options—and equally important, understanding what our patients’ wishes may be—is an honored part of the physician/patient relationship, especially for primary care internists, family physicians and oncologists.  The reality is that we have not been as successful as we need to be in encouraging these discussions.

We have tried for years to get people to sign living wills and provide durable powers of attorney for health care.  Medical professionals need guidance—preferably in advance of the moment--on what patients want done, either at the time when their lives are coming to an end or when they may not be able to speak for themselves.

There is nothing inhumane or inappropriate about that discussion.  It is a discussion that no one wants to have, and one that is never easy.  But it is the right thing to do, and there are plenty of medical and patient organizations who have devoted considerable effort to encourage these discussions.  There is nothing about the discussion that is preordained to limit care.  In fact, some patients and families want “everything done” even when medical professionals find that directive to be against their own ethical instincts.

I learned these lessons early in my career as a medical oncologist.  Having discussions about end-of-life is an unfortunate reality in cancer care.

What surprised me at the time—when there was less I could do for many patients than is the case today—was the number of patients and families who told me they were more interested in comfort than they were in treatment.  They wanted to be certain someone would be there to care for them through their last days or months and ease their pain and suffering more than they were concerned about getting the next drug which more likely than not would have given them more discomfort that hope and relief from their suffering.

Those discussions had an incredible impact on me as a person and a physician, and the experiences remain with me today.

I didn’t euthanize anyone, and never, never would such a thought enter my mind.  My patients taught me that having a heart beat and being alive to see the sun rise another day was not living and was not life.  That was their decision, not mine.  I would do what they wanted, but almost always what they wanted was care, compassion and relief from pain. That is what we tried to offer.

When I recently heard the gross misrepresentation surrounding the portion of the health care bill that referred to paying health care professionals for these end-of-life discussions, I couldn’t help but be concerned and confused.  When I heard the rhetoric stormed up to a level of “death panels” and “Nazis” I knew we had gone too far.

I have stayed out of the politics of health care reform in these blogs, and will continue to do so.  But as I mentioned in my comments the other day, someone has to be an honest broker of what is going on out there, dealing with some of the rhetoric that is coming from both sides and which is designed to inflame rather than inform.

If you are a physician who has cared for a patient for years or even decades, you know that person as a friend as well as a patient.  Your goal is to provide the best care you can, but also to provide comfort when cure is no longer the goal.  You counsel your patient and their family on what you think the best path may be at that moment and in the future, whether it be treatment or comfort.  You act as protector for their wishes, the guardian of their health, and at the appropriate time the minister for their comfort.

You are not a Nazi.  You are not triaging who will live and who will die.  You are not some thoughtless bureaucrat who is concerned about how much it will cost to keep someone alive.

I have stood in the places of remembrance for people who were killed without cause.  I have cried my tears over those who were lost by senseless murders.  I have read the writings of those who survived.  And I will never forget.

So please do not dehumanize the memories of those who suffered from terminal illnesses or the ravages of age by suggesting that somehow our great country, our great people, and our great physicians and health professionals are somehow going to become agents of the state and in turn agents of death. 

Please understand that dignity in our lives must always be paramount in our thoughts.  Discussing end-of-life wishes is humane and appropriate.  Providing counseling, care, hospice and pain control is in the noblest traditions of our profession and our country.  Listening to our patients and their families is what we do, and what we pledge to do.

Continue with the debate and the discussion, make your case and make your points, but do not dishonor those of us who have tried to do the right thing for our patients, families and friends and the memories of those who have died in peace, honor and dignity by make the choices that were best for them.

For once, some good news: Plain and simple, prevention works. 

“The message from our analysis of the data from the EPIC-Potsdam study is clear: adopting a few healthy behaviors can have a major impact on the risk of morbidity.  The participants with all 4 healthy lifestyle factors had a reduced risk of major chronic disease of almost 80% compared with those with none.  These results applied equally to men and women.”  So say the authors of a new research report that appears in today’s issues of the Archives of Internal Medicine.

But wait a moment.  As pointed out in an editorial in the same issue, this really isn’t news.  We’ve known this for a long time. 

So if we know so much, why can’t we do something about it?  That, my friends, is the $64,000 question.  Or perhaps that figure is really outdated.  Today, it’s the multibillion dollar question.  Just go ask the folks in Washington.

The research took a lot of effort, but is stunningly simple in its theory. 

The researchers followed over 23,000 people in Potsdam, Germany for around 8 years.  They measured four markers of a healthy lifestyle, including: never smoking, a body mass index less than 30, performing 3 ½ hours a week of legitimate physical activity such as bicycling or sports, and following a healthy diet including a high intake of fruits, vegetables, whole grain bread and low red meat consumption.

After entering the study, the researchers followed the participants to see if they developed cancer, diabetes, a heart attack or a stroke.

The good news was that almost everyone had at least one healthy behavior “marker,” and only 4% had none.  On the other end of the scale, 9% had practiced all four elements of a healthy lifestyle.

The impact of doing the right things for one’s health was dramatic:

• If you had all four healthy behaviors, your chance of getting a serious illness was reduced by 78%.  The impact of a healthy lifestyle was the same for men and women.

• Having a BMI less than 30 had the greatest overall impact, followed by never smoking, physical activity for 3 ½ hours a week or more, and adhering to good dietary habits.  Having a BMI less than 30 was a very strong protective factor with respect to diabetes.

• Never smoking exerted a stronger protective effect on heart attack and diabetes than on stroke and cancer.

• Physical activity reduced diabetes and heart attack more than cancer

• A healthy diet decreased the risk of cancer, diabetes, stroke and cancer.

• If you never smoked and had a BMI les than 30, you had a risk reduction of 78%, similar to someone who practiced all four healthy behaviors.

• You can mix and match the healthy behaviors, but all of the combinations had a benefit in reducing serious, chronic disease.  The combination with a surprising effectiveness on reducing risk was physical activity and healthy diet, which was greater than the researchers had expected. Even current and former smokers reduced their risk of serious illness if they practiced other healthy behaviors.

So what does this study tell us?

First, as noted at the beginning of the blog, prevention works.  No surprise there, I guess, since the authors themselves point out there have been several studies which all point in the same direction.

But it also leaves open the question that frustrates so many of us:  If we know so much, why is it that we accomplish so little when it comes to diet, exercise, smoking cessation and maintaining a healthy body weight?

As the authors note, “Although improvements in some behaviors have occurred, notably the decline in the prevalence of smoking, substantial proportions of the population still engage in behaviors that are not conducive to achieving and maintaining health.”

They go on to say, “The data from the EPIC-Potsdam study show the unfulfilled potential of preventing chronic diseases.  Adhering to the recommendations for the 4 lifestyle factors considered in our analyses can potential yield enormous reductions in the onset of major chronic disease such as (cardiovascular disease), diabetes and cancer…”

“Our results and these of others emphasize the importance and urgency of continuing vigorous efforts to convince people to adopt healthy lifestyles.  Because the roots of these factors often originate during the formative stages of life, it is especially important to start early in teaching the important lessons concerning healthy living.”

Not exactly what I would call a news flash, but nonetheless a very important message for all of us to hear and incorporate into our daily lives.

The editorial which accompanied the article, written by David Katz, MD from the Yale University School of Medicine, points out that we have known for some time that tobacco use, diet and physical activity account for a huge number of premature deaths in the United States every year.

As noted by the writer, “If ever a matter of public importance belied the notion that knowledge is power, this decade of underutilized knowledge was it.  And if we are once again to be updated in 2013 (regarding the number of premature deaths),there is little cause to think, based on our progress to date, that we will have fared much better across an informed expanse of 2 decades, although progress in tobacco control warrants honorable mention.”

Not a very ringing endorsement of our progress in helping people lead healthier lives, is it?

Some people say we are trapped by our genes.  Dr. Katz points out that “even gene expression submits to the power of lifestyle…With the knowledge we have already in hand, we can nurture nature.”

“Across an expanse of policies, practices, programs, personal responsibility, and political will yet to be mustered and some cases yet to be devised—we have miles to go before we sleep.”

Couldn’t have said it better myself.  Now that I think about it, I have said it myself, time and again and again and again.  And so have many others.

We are frustrated in our efforts to change behaviors, and clearly need to find better ways to get to the goal. 

Hopefully—and this is the political message of this blog—our current national debate about health care reform will get back to the core issues facing us as a nation, one of which is how we pay for and encourage prevention.

Knowing you can reduce one’s risk of getting a serious disease by 78% to me sounds like a very powerful incentive to make changes. Now all we need is the personal and national will to get the job done.

Somehow, we need a huge attitude adjustment around prevention and healthy lifestyles. 

How we get there is the billion(s) dollar question.

I suspect I am one of many who are not unhappy that Congress has finally taken their August recess.  I suspect I am also one of many who are alarmed and upset by the next act in this play, which is the rancor and near-violence we are seeing on our TV sets every day at the various town hall meetings when health care reform is the topic of discussion.

This isn’t what health care reform—or whatever you choose to call it—is supposed to be about.  This is a serious matter for our nation and for many of our fellow citizens. It deserves thoughtful and deliberate discussion.

The events of the past several days have left me distressed and concerned.  The anger, the accusations, the lack of decorum and the distortions and occasional “untruths” being promoted by all sides have left me dismayed.  It is even beginning to affect relationships among friends and families.

All of this has led me to think about what is important to me, and for my family.  What do I really want from health care reform? 

1)      I want to know that I can get health insurance.

Sound simple?  It really isn’t. 

I have been in a medical practice or otherwise employed most of my adult life.  I have always had health insurance for me and my family.  I have had the opportunity to pick my plan, and pay more to my employer and a bit more in co-pays and deductibles so I could get the coverage I wanted. 

But I can not let go of the thought that I am one step away from disaster.

If I had to go out into the private market today, I would have difficulty getting insurance.  Why?  I have a couple of fairly common medical problems.  I am older.  Members of my family also have some medical problems.  I suspect we would be “rated” and pay through the nose if we had to purchase our own insurance, if I could even get it. 

I have “pre-existing conditions” and despite my efforts to take my medications and exercise regularly to keep those chronic conditions under control, there aren’t many companies who would welcome me with open arms.  I am a “high risk”, despite doing what I am supposed to do to avoid a more serious medical problem. 

But what if I had cancer?  What if I had heart disease?  What if I had type 2 insulin dependent diabetes?  Do you honestly think I could get insurance anywhere other than through my employer?  And if I was in a small business—such as a medical practice—can you imagine what my illness would do to the premiums of my company?

We know that these scenarios are not unusual or unique.  Listen to the stories, read the studies, talk to the people who have faced the problems.  These are real issues, and these are everyday occurrences for honest, hard working people that are right there in your community.  They are your neighbors, they may be your friends, and they may be your family.  They are not fictional, and they have a very real interest in the outcome of this debate.

2) I want to be able to afford insurance.  I want the system to be more effective in terms of quality and less expensive (or at least reasonable) in terms of cost.

We are out of control when it comes to spending on health care.  That’s it, plain and simple. 

People who want insurance and need care can’t get it; some people who have insurance want everything.  Doctors say that they have to do all the tests they do because of “defensive medicine,” yet we don’t talk seriously about tort reform.  And even if we had tort reform, I don’t believe that it will resolve the issue of over-ordering tests and procedures. 

Quality of health care is not top of mind for the medical profession in this debate.  We order too many tests and studies too often without evidence that they make much difference.  We can spend thousands of dollars on scans, but can’t afford dollars for vaccinations or “well care.”  We install imaging machines in offices to make more money, because our physician payment system distorts the incentives substantially in favor of doing more tests.

We talk about the “savings” that will come from the widespread use of health information technology, yet we don’t have standards that will allow computers to talk to each other.

We pay lots of money for doctors and hospitals to do things.  We pay a pittance for those who try to prevent disease, and we pay relatively even less to those who are charged with trying to coordinate the complex medical care of seriously ill patients. 

We need to promote preventive medical services, pay adequately for our necessary (and at the very least) basic medical care including primary care, obstetrics/gynecology, and general surgery.  We are losing doctors in these specialties, and it will take decades to replace them.

3) I want to know what I am being charged for when I receive a medical service, what my insurance covers, and what I owe in clear, understandable language. I want to know those fees are reasonable for the service provided.

We are charged substantial fees for some medical services, and as ordinary people we have no idea whether or not that fee is reasonable or the service is appropriate. 

I recently got a bill for the treatment of a member of my family.  Two 1 centimeter superficial lacerations resulted in a $1700 bill, including a remarkable physician charge which was in fact “upcoded” (that means the doctor “coded” for a service that was a higher level code than appropriate for the service that was performed.  I assume it was an “honest” mistake, because if it wasn’t it would be fraudulent).  The skin glue was charged out at about 9 times the purchase cost available to me on the internet.

I get hospital bills that simply say “pay us money”.  No itemized bill. No insurance bill or statement, just pay us the money. 

Patients go to doctors, who look at you sideways if you ask in advance what their charges are for their services.  Keeping their fees secret has been a long tradition among my colleagues, and in private conversations they tell me they should be able to charge whatever they want to.

Some physicians say that we should individually contract or negotiate the costs of our medical care. The man I cared for a couple of weeks ago on an airplane was in no position to negotiate the costs of his care as the emergency medical technicians wheeled him off the plane on his way to the hospital.

Hey, folks, here’s a bulletin: there IS no private market in health care, except for cosmetic and concierge services.  Patients are at an incredible disadvantage in understanding the costs of their services. There is no transparency regarding the costs of medical care and services. The prices are jacked up for those who pay because others can’t—or don’t—pay their bills. 

My personal experience confirms that you have to go to incredible lengths to get answers to even simple questions, and I am considered an expert in this stuff.  If you are an “ordinary patient,” I can’t even begin to imagine how you would understand the charges and the payments.

4) I want to know what treatments and medicines work, what doesn’t work, and if we know whether or not it works.  I want to know that I am getting appropriate, quality care for my medical problem

That is NOT rationing.  It is information.  We need more of it.  We are doing too much of what doesn’t work, too little of what does work, and who knows how much of what may or may not work.

It may be a surprise to some of you, but there are many thoughtful physicians and top-tier medical professional organizations who have been clamoring for this type of research.  I have said this publicly and will say it here: It is time to understand that just because a doctor recommends something, doesn’t mean it works or is the right treatment for you.  But you (and too frequently even your doctor) don’t know that, because the research hasn’t been done. Think about hormone replacement therapy, and you will understand what I am saying.

Here’s another bulletin: In too many circumstances, you have no way of knowing whether or not you are getting quality medical care. 

Too often you as a patient have no way of knowing if you are receiving the right recommendations for your health, whether or not there is a less invasive or less expensive treatment option, or whether the treatment has been shown to effectively treat the condition you have.

The medical profession should embrace quality, quality improvement, transparency, and accountability to demonstrate they are providing the best medical service.  Unfortunately, this has not been exactly at the forefront of the discussion about health system reform.  If it was, I would venture that patients and those who foot the bills for these services would greet the effort enthusiastically and reward health care professionals appropriately.

5) I want confidence that my insurance will be there when I need it for a serious medical illness.

We have too many instances—and too many bankruptcies—where “satisfied” people suddenly found themselves not so “satisfied.”  I am willing to bet that you (and me) have no idea whether or not your insurance will be a facilitator or a barrier to your care if you or someone you love becomes seriously ill with a disease like cancer.  You just don’t know. 

So don’t stand there and rail against your Congressman or Senator because you are “happy” with your health insurance.  I wonder how many of you have had a serious, prolonged illness in your family.  If your experiences have been positive, terrific.  But don’t discount that many others have not been so fortunate.

I am looking for someone who is a “trusted voice” or “honest broker” who can bring this discussion and debate about health care reform back to the center, who can tell us what is in the bills and what is not.  Too many lies, too many untruths and too many distortions have me feeling there is no such voice being heard in the land today.

Then there is the question of what we are really talking about anyway.  There isn’t one bill about health care reform; there are several.  And there is one that hasn’t even made it to the public.  (I find myself hoping against hope that those six senators will have the wisdom to get this close to “right” so we can have something that will ignite the passion of those of us who want something done, yet want it done with balance and the participation of both sides of the aisle.)

When this discussion started several years ago, the American Cancer Society had four principles that were core to the Society’s efforts surrounding health care reform.  On reflection, those four principles articulated at that time are consistent with what many of us want today: 

• Adequate—Timely access to the full range of evidence-based health care, including prevention and early detection.
• Affordable—Costs are based on the person’s ability to pay.
• Available—Coverage is available regardless of health status or prior claims.
• Administratively simple—Processes are easy to understand and navigate.

Aren’t those principles what this is all about?  Can’t we focus on those principles and move this process forward?  Is it really that difficult to get this done?

We need some sanity in this discussion.  We need to think as individuals, communities and as a nation about what is important to us when it comes to health care reform and our health care in general.

I suspect there is a sense in the country that many of us are willing to “pitch in” if everyone pitches in.  This shouldn’t be about us against them.  This shouldn’t be about “I’ve got mine and you can go to h---.”  We are better than that as people and as a nation.

It’s time our public discourse and our political/legislative process should reflect the best of what we are as a nation.  We need to get this done.

The headline on the press release says, “More Than Half of Texas Physicians Do Not Always Recommend HPV Vaccine to Girls.”  That sounds bad. 

The “sub headline” in the press release says, “Approximately 50 percent do not recommend the vaccine.”   That sounds really bad.

The problem is that the headline is misleading and the “sub headline” isn’t true.

When you read the actual research paper, you find out that 75-87% of the doctors are making the right recommendation most of the time. 

Given the strong social and political interest in this topic, those differences have significant implications, especially given the headline and sound bite world we live in today.  And that could influence how this paper may be used to drive public policy.

First, a bit of background:

We know that the majority of cervical cancers in the United States are caused by two types of human papilloma virus, or HPV. 

A cervical cancer vaccine was introduced in the United States in 2006 which could significantly reduce the risk of cervical cancer from these viruses.  We also know that the vaccine has not been used as often as was predicted, with somewhere between  6% and 25% of 11 to 18 year old girls in this country having been vaccinated to date.  We also know that routine vaccination is recommended for 11-12 year old girls by several reputable organizations and federal panels. 

The reason for the young age is that the vaccine is not effective once a girl becomes sexually active.  Additional recommendations, including those from the American Cancer Society, include offering the vaccine for girls as early as 9 years old, and as a “catch-up” for girls ages 13-18.  The Society also recommends a discussion between a woman and her health care professional about cervical cancer vaccination if she is between the ages of 19-26.

The current report appears in the August issue of the journal Cancer Epidemiology Biomarkers and Prevention. 

The researchers had three primary questions they wanted to answer with their study:

First, they wanted to find out whether or not physicians were recommending cervical cancer vaccination to 11 and 12 year old girls.  Second, they wanted to know if physicians would recommend the same vaccine to 11 and 12 year old boys if it became available, understanding that studies have shown the same vaccine now used in girls will also reduce genital infections with HPV in boys.  Finally, the researchers wanted to know if physicians agreed that HPV vaccination in 11-12 year old girls should be mandatory.

The study was conducted in Texas, which has an interesting political history with regard to cervical cancer vaccination.  Briefly, after the vaccine became available, the Texas governor issued an order that the vaccine would be mandatory in 2007 for girls entering the sixth grade in Texas.  However, after strong political protests, the legislature voted to rescind that order.

The researchers conducted an email survey to answer the questions they had posed above.

Focusing on just the physician recommendations to vaccinate 11 and 12 year old girls, the study concluded, “Half of the physicians in this study did not follow current recommendations for universal HPV vaccination of 11-to-12 year-old girls.”

Doesn’t sound too good, does it?

But wait a moment.  In a graph in the paper, it says that 75.4 of the doctors “always/usually recommend vaccine to girls” in the primary target population of 11-12 years old. If you look at the same number for girls ages 13-17, the percentage actually climbs to 87.5%.

As a physician who has been in practice, and as someone who is very interested in the need to get doctors to recommend appropriate cancer screening tests to patients, that number actually sounds pretty good.  In fact, I think it would be very difficult to get much better than that, especially in the 13-17 year old category.

Essentially, the headline all depends on whether you think there is much practical difference between “always” and “usually.”  Frequently, researchers combine those categories into a single number because of the practical implications.  Indeed, in their own graphical presentation of the data, the researchers in this paper combined the data.  It’s when they wrote the conclusions that they elected to highlight that differences.

And that “sub headline” which says that approximately 50% of the physicians in Texas do not recommend the vaccine should just go away. It is a serious misstatement of the facts in the paper.

Using this information, the authors conclude that “additional efforts are needed to improve clinicians’ awareness of and adherence to national recommendations.”

The study also noted that the most effective way to get these girls vaccinated is to mandate the vaccine.  “State vaccination requirements that would ensure high uptake of HPV vaccines also have the potential to narrow existing racial, ethnic, and economic disparities in cervical cancer incidence and mortality…(More than) 40% of Texas physicians in this 2008 study supported mandatory HPV vaccination.”

The authors do point out that there are several barriers to vaccination, including costs and misperceptions of safety and effectiveness—as well as personal parental beliefs—that may impact the rate of vaccination.  But they also imply that doctors aren’t doing their job as well as they should. 

I simply don’t agree that the data on its face supports that conclusion, and I don’t agree that the data necessarily reflect the opinions and/or practices of physicians across the country.  When I dug deeper into the study, I found I had questions about how representative the sample was of all practicing physicians, not to mention questions about how many internists and gynecologists actually treat 11 to 12 year old girls in their practices.  I also thought the study was (unintentionally) biased towards younger physicians whose opinions may not reflect the larger (and older) primary care physician workforce.

Some final items:

I want to make it clear that in my opinion this vaccine is useful in preventing cervical cancer.  I have no personal opinion (nor does the American Cancer Society) as to whether or not the vaccine should be mandatory.  The Society does recommend routine vaccination of girls 11-12 years old.

As I mentioned to a reporter during an interview yesterday, I believe that readers of this blog should be aware of potential conflicts of interest when I write about particular research reports.

In this case, one of the senior authors on the paper lists the following conflicts:

She is a co-Principal investigator on an investigator-initiated grant funded by the company that currently is the sole supplier of the cervical cancer vaccine in the United States; serves as a research consultant/collaborator on a research project sponsored by that company; and sits on one of that company’s advisory boards.

I would add that the study was funded by the Texas Medical Association Foundation.  I applaud them for supporting this research, as well as their efforts to vaccinate children in areas of the state with low vaccination rates.

I could not find any indication that the company which makes the vaccine directly or indirectly supported this research, or made some type of grant which helped get the study completed.

The key “take away” message for me is that this particular study is a case example of how one can get attention by emphasizing the problem, as opposed to applauding the success.  In my personal opinion, it shows how you can tilt the impact of a scientific paper depending on the message you want to send and the headlines (and sub headlines) that you write. 

To sum it all up, whether you think this glass is half empty or half full may just depend on your point of view.

A recent headline saying that prevention is under attack as part of health care reform really bothered me.

One of my core principles as a physician has been that preventing illness when possible is much better than treating illness.  I can’t even begin to imagine a revamped health system that does not shift emphasis and money to prevent disease. Billions (if not trillions) for technology and machines and pennies for prevention is unbelievable and unacceptable.

Is our health care in this country technologically outstanding? Absolutely. You can’t find anywhere in the universe that has more fancy medical machines per person that the good old US of A. Giving us good value, effective care and long, healthy lives for the amount of money we are spending?  No way.

The only solution I have to improve my odds of living longer and healthier is to do whatever I can to take care of myself, and that means incorporating prevention into my daily life.  I happen to think that prevention is also the right prescription for the country.

Prevention has always been close to my heart professionally as well.

Years ago, I started my practice as a medical oncologist.  I transitioned from cancer medicine to primary care internal medicine because I believed in prevention.  I encouraged “primary” prevention (weight loss, healthy diet, exercise, stop smoking), and quickly came to realize that it was difficult to get people (including yours truly) to change their ways.  I accepted (and still do, since I need some help myself) that much of what I did as a doc had to be “secondary” prevention, including treating high blood pressure and cholesterol. But that didn’t diminish my efforts to encourage my patients to practice primary prevention as well.

Combined with screening, counseling, and a lot of cajoling I believed then and believe now that nothing works better to improve the health of large numbers of people than a focus on prevention through a culture of health.  People need to be encouraged to take charge of their health and surround themselves with a commitment to prevention and living a healthy lifestyle. 

But we don’t, and the results show up in all sorts of statistics: we are fatter, we are more sedentary, and we have increasing amounts of disease related to lifestyle issues. 

“Metabolic syndrome” is a term that didn’t exist in my dictionary when I was in practice.  Now we recognize it as one of the leading causes of diabetes, heart disease, elevated cholesterol and maybe even indirectly to cancer (14% of cancer deaths in men are related to overweight and obesity.  For women, the number is 20%).

So as we build our hospital beds larger and our fancy scanners bigger and as we fatten up as a nation and expect doctors to pull us back from the brink of disaster after disaster, we have lost sight of the fact that medicine can’t fix everything—even if we had all of the money in the world going to health care.  The path, as they say, is unsustainable and in no small part “we being us” is responsible.

There are many of us who believe the only way to get us back on track is to emphasize prevention as an intrinsic part of health care. We can’t prevent every illness or disease, and we can’t cure everything.  We could do a much better job on both counts, but ultimately it starts with us.

I promise you I know how tough it is to try to do the right things when it comes to prevention. 

I have tried and tried to lose weight, but keep getting stuck (I call it the “Groundhog Diet” after the Bill Murray movie “Groundhog Day” because I keep losing and gaining the same weight month after month).  But I won’t give up and I keep hoping that one day I will get it right. 

I try to exercise whenever possible, and now incorporate 10,000 aerobic steps into my day, even when I am travelling (which I do regularly).  I take my own cereal and fruit on my trips, so I don’t have to eat the hotel buffet breakfast—a sure place for disaster and pounds. On occasion I even pack some vegetables so I can eat better when I get to the hotel late at night. 

I avoid those little snack packs on the plane, which can add up if you have one of them on each leg of each flight.  I don’t have to worry about smoking (thankfully), but alcohol consumed wisely still adds on the pounds (2 jiggers of alcohol—which is about 3 fluid ounces-- provides 240 calories.  If you do that 3 times a week, that’s 720 calories.  There are approximately 3500 calories per pound. That adds up to 11 pounds a year.  If you “pour heavy” or drink more than that, you can quickly see that’s a lot of weight.)

Why do all this?  And why keep trying even though I shamefully admit I am not successful in everything I try to do when it comes to prevention?

It’s real simple: I want to do what I can to stay well.  I am terrified of becoming another statistic in the large maw of our health care “system.”  If I do, I want to know that I did what I could to avoid the problem.  And I will keep on trying despite my very human limitations.

Prevention simply makes sense.  Is it free?  Some is, some isn’t.  Can we afford it?  My answer is how can we NOT afford it?  Does it belong in whatever health care reform we adopt? You betcha.

There are also community aspects to health-related prevention, and that in fact is what those headlines were about.

It turned out that the prevention issue in question was regarding funding for community construction projects designed to improve health, such as parks, bike paths, and local farmer’s markets. 

I can understand why there might be debate on that item, since some might think such infrastructure projects don’t belong in a health reform bill.  But that doesn’t mean they don’t work—they do.  There is research to back it up, and the public health and nutrition folks have been clamoring for attention to these “healthy community” investments for years.  So, in my personal opinion, it doesn’t make much difference where the funding comes from, so long as it comes from somewhere.

My hometown in southwest Georgia recently built just such a walkway (they also do an annual community-wide weight loss program which has been very successful). It surrounds a large water reservoir, and is exactly one mile in length.  My wife and I make it part of our weekend routine—weather permitting—whenever we are home, walking five or more miles on Saturday and Sunday.  And we aren’t alone, not to mention the families, friends and church groups that get together in the park for a picnic or to fish or just watch the birds or the other people.

We are also fortunate in our town to have a farmers’ market which has a large selection of inexpensive, fresh vegetables—another “prevention” strategy that works, especially for people on limited budgets.

These strategies may sound simplistic to some of you, but they are not. And they are all part of “prevention” and a culture of health.

Think about your community, and whether or not you have parks, bicycle paths, or places to walk safely. 

You are fortunate if you do, because many people don’t have access to these amenities.  Too many people live in communities where they don’t even have access to a grocery store, and many of those same people live in places where they don’t feel safe walking outside their door.  This is, unfortunately, a reality in this country.  It doesn’t have to be this way nor should it be.

Prevention in its encompassing form is the one thing we can do to get this mess under control. 

Making communities safer and healthier, reversing our love affair with watching ourselves get larger and larger, getting screened for cancer and other diseases, getting treated for blood pressure and cholesterol (and taking our medicines) as well as stopping smoking among other things is the  commitment we can make to ourselves, our children and future generations.

The reality is that if we don’t take care of prevention, there won’t be enough money in the world to take care of us.  It is just that simple.

Prevention is a key part of health care reform.  Let’s keep it that way.