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Dr. Len's Cancer Blog

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Alcohol Is A Clear Danger To Women's Health

by Dr. Len February 24, 2009

A study released today by the Journal of the National Cancer Institute is certain to give women pause when they find out that drinking alcohol of any type significantly raises their lifetime risks of being diagnosed with certain cancers. 

 

The research, performed in the United Kingdom and involving over 1.2 million women is likely going to be the definitive answer to the questions regarding the harms of alcohol when it comes to the risk of getting cancer.

 

This is no small question, since this issue has dogged cancer researchers for many years.

 

The American Cancer Society, for example, currently advises women that they should limit their alcohol intake to at most one drink daily.  Other studies have suggested that alcohol has significant positive health benefits, especially when it comes to reducing the risk of heart disease.  Resveratrol—a chemical found in red wine—is all the rage these days as researchers try to demonstrate that it is the “life-extending” component in red wine.

 

But this study puts all of that to rest with its findings that any alcohol consumption by women is likely going to increase their risk of certain cancers. 

 

The authors followed these women for an average of 7.2 years.  Overall, as they reported in the study, the average age of the participants was 55years old at the start of the study, which recruited the women from 1996 through 2001.  Most of the women had a low to moderate alcohol consumption which meant that 24% were nondrinkers, 29% had 2 or fewer alcoholic drinks per week, 23% had 3-6 drinks per week and the remainder more than 6 drinks weekly.  The overwhelming majority (98%) consumed less than 21 drinks weekly, or an average of 3 or fewer daily.

 

If a woman drank alcoholic beverages, the study found that she had an increased risk of several cancers, including cancers of the oral cavity and pharynx, the larynx, the esophagus, the rectum and the breast.  When further studied, the increased risk of cancers of the esophagus (or swallowing tube) was limited to cancers related to smoking (squamous cell cancers), not to those thought to be related to reflux and obesity (adenocarcinomas).

 

The increased risks for cancers of the head and neck and esophagus were increased only in those women who were current smokers in addition to alcohol consumers.  Women who only drank alcohol did not have the increased risk of head and neck and esophageal cancers.

 

(I should also note that there were several cancers were risk was actually decreased with increasing alcohol consumption.  These cancers included thyroid, non-Hodgkin lymphoma, and kidney cancer.)

 

For those cancers where the risk was increased, the amount of that increase was substantial.

 

The researchers found that the risk increased for every drink a woman took.  So, the more alcohol a woman consumed, the greater her risk of getting the cancers associated with alcohol consumption.

 

When the researchers calculated the impact of alcohol on the total number of cancers diagnosed each year in women in the United Kingdom, they found that alcohol consumption accounted for 11% of all breast cancers in that country, 22% of liver cancers, 9% of rectal cancers and 25% of all head and neck and squamous cell cancers of the esophagus.

 

Granted, some of those cancers such as liver cancer aren’t particularly common, so even a 22% increase isn’t that noticeable (there were 250 extra liver cancers due to alcohol in the UK every year, according to the authors).

 

But 11% of all breast cancers—or 5000 women every year in the United Kingdom—developed as a result of alcohol consumption.

 

In an editorial which accompanied this study, the authors point out that there is now a conflict between the reported health benefits of alcohol, and the increased cancer risk for women as reported in this study.

 

They emphasized the finding of the study that about 13% of all cancers of the breast, head and neck, esophagus liver and rectum in women could be attributed to alcohol:

 

“From a standpoint of cancer risk, the message of this report could not be clearer.  There is no level of alcohol consumption that can be considered safe… (Emphasis mine)

 

“It might be reasonable to suspect that many women in the lay public who are asking physicians about any possible safe effects of alcohol are middle aged; for this large group, the only reasonable recommendation we can make is that there is no clear evidence that alcohol has medical benefits.”

 

So, women take note:

 

The evidence from this study is detailed and compelling.  According to experts, there is little doubt that this research shows conclusively that alcohol in any amount is clearly a danger to your health when it comes to increasing your risk of cancer.  There is simply no way to avoid that conclusion.  And, it doesn’t make any difference what type of alcohol you drink, whether it is beer or hard liquor, red or white wine.  They are all the same when it comes to increasing the risk of these cancers.

 

Anyone for a club soda with lime?

 

 

Filed Under:

Breast Cancer | Diet | Prevention

Is Information Bad For Your Health?

by Dr. Len February 23, 2009

You are diagnosed with cancer.  You remember some of what the doctor said, but not much.  So, following the recommendations of the American Cancer Society, you do everything you can to get information online and elsewhere that may help you better understand your treatment and your disease.

 

That’s the right thing to do, isn’t it?

 

Maybe yes and maybe no, if you agree with the findings of a paper published today in the journal Cancer.

 

The article, which describes research on how patients with colon cancer sought information about their disease and how that information-seeking behavior influenced their treatment, looked at survey responses from 633 patients in Pennsylvania initially diagnosed with colon cancer in 2005.

 

The researchers measured a number of items including the patients’ general health, education, age, marital status, race/ethnicity and disease stage.  They then determined which patients used the new targeted therapies Avastin and Erbitux for the treatment of their disease.   They further broke down the survey group as to whether or not the treatment with these drugs was “on-label” (that is, the patients received these drugs when the disease had spread to other parts of their body) or was “off-label” (which means they received either of these drugs before there was evidence of disease spread beyond the primary cancer site).

 

They then determined whether or not the patients used information sources to find out more about their disease.  Newspaper articles, internet, television and radio, telephone hotlines and books or pamphlets were among the types of sources examined.

 

What the authors found was that 14% of the colon cancer patients had heard about targeted therapies, and that 10% of the patients had actually received one of the two drugs in question.  Of the 102 patients in the survey whose disease had spread at the time of diagnosis, 51% had received either Avastin or Erbitux (which was considered appropriate treatment) while 3% of the 527 patients diagnosed with localized disease received the drugs even though their disease had not spread (which was considered inappropriate treatment). 

 

As noted by the authors, “approximately 25% of those who reported receiving the drugs were receiving it for non-FDA-approved indications.”  To me, that means that one out of four patients who received these drugs shouldn’t have had that treatment.

 

The results of the study showed that “high levels of treatment information seeking were associated strongly with both hearing about…and receiving…targeted therapy for cancer.”  Information seeking increased both on-label and off-label usage of these targeted therapies.

 

The authors go on to draw several conclusions about their study and its implications.

 

First, they suggest that patients who seek information influence doctors’ decisions as to what treatment to prescribe.

 

Then, they go on to say that this information seeking could persuade doctors to use a drug even when it is not appropriate, as was the case with off-label usage in this study. 

 

“Adjuvant use of targeted therapy is an area of active research, but some experts fear that oncologists may inappropriately consider using adjuvant targeted therapy in selected patients…The diffusion of information may be a key factor in off-label use and that media exposure and direct to consumer advertising (DTCA) may alter the demand for new technologies…

 

“However, if patient information seeking leads to an increase in inappropriate access, then we may find overall reductions in the quality of care or, worse still, an increase in patient harm.”

 

The authors conclude their report by noting that their study shows that most cancer patients are trying to get information about their disease and that once they get that information they may receive both appropriate and inappropriate treatment.

 

That is a pretty important statement, because it suggests that all types of information seeking from different places may not be such a good thing.

 

But a couple of things need to be kept in mind before assuming that these findings are necessarily the final answer to this question.

 

Let me point out some information that may help put this study and my concerns into perspective.

 

Erbitux and Avastin are both drugs that have shown benefit in the treatment of advanced colorectal cancer.   They were both approved for this indication by the FDA in February 2004.  Neither drug has been reported so far to be of benefit in treating patients with localized disease in an adjuvant or preventive fashion to decrease the chances of recurrence.  So, I agree that any use of the drug in this fashion outside of a clinical trial is not appropriate.

 

Both of these drugs are very expensive, and there are few patients who could afford them if they didn’t have adequate health insurance or significant money in the bank to pay for them or the co-pay. 

 

The median age of the patients surveyed for this study was 70 (the age range was 26 to 99 years old), which means the majority of the patients were on Medicare.

 

Medicare patients still have to pay 20% of the allowed charge for these drugs, which could easily amount to thousands of dollars.  Many Medicare patients don’t have co-insurance that would cover these out-of-pocket costs.

 

Having a college education was a factor that stands out for patients who heard about and received these drugs, which leads me to believe that the same patients who were seeking information were better educated, probably better off financially and probably had better insurance.  Which of these factors actually influenced their ability to access these drugs is uncertain.

 

Finally, 3% of the patients in the study—or 19 people—got one of these drugs “off label.”  That actually is not a particularly large number. 

 

What if these patients had in fact been misclassified as to the stage of their disease?  What if in fact their disease had progressed between their first diagnosis when it was localized and the time the survey was done a year or more later?  And, we should note that there were clinical trials started in 2004—before these patients were diagnosed or surveyed—to study the value of adjuvant treatment of colorectal cancer with these drugs. 

 

What if some of these “off-label” patients in fact had decided to participate in one of these trials?  In that case, the use of these drugs would have been perfectly appropriate and in keeping with good clinical practice.

 

The risk here is that we create relationships and draw conclusions that may not reflect the actual cause for the observation.

 

It is my personal opinion that patients should be informed about their disease and their treatment options.  It is also my opinion that it is the responsibility of the doctor treating a patient with cancer to provide appropriate treatment recommendations, and avoid succumbing to patient pressure to use a drug that is not appropriate.

 

Cancer drugs are serious business.  Just ask any patient who has received them.  They are not the same as an antibiotic that a doctor may give you for a cold, or an expensive antihistamine advertised on television when a cheaper over-the-counter version will work just as well.

 

Cancer drugs should not be used when the clinical research or FDA approval does not support their use.  Using these targeted therapies in the adjuvant treatment of colon cancer outside a clinical trial is not good medicine.

 

Having said that, there is now an increasing focus on the off-label use of cancer medicines as reflected in several past and recent postings on this blog.  There certainly are situations where the off-label use of cancer drugs is wrong, and has led to harm, such as the use of ESAs to treat the anemia of cancer that is not related to treatment for the disease.

 

But to draw the conclusion that information-seeking from organizations such as the American Cancer Society and other reputable organizations can lead to patients demanding their doctors treat them inappropriately is something that needs to be supported with very firm and clear evidence.

 

As you can probably tell from my comments, I am not convinced that this research supports that conclusion.

 

In the meantime, I am going to stick with my basic premise about information and cancer: Get the information you need so you are informed about your disease and its treatment.  Get that information from reliable sources.  Know that your doctor is recommending chemotherapy that meets appropriate guidelines for your cancer, whether or not that treatment is on-label or off-label.

 

Hopefully as we learn more about how patients and doctors get information and apply that information we will be able to get a clearer picture of all the considerations that go into making a treatment decision.

 

Until then, keep on seeking.

Filed Under:

Cancer Care | Medicare | Treatment

Dr. Jeanne Calle

by Dr. Len February 18, 2009

The start of our day here at the American Cancer Society was quickly punctuated by the rumor—and then the confirmation—that one of our friends, a valued colleague and mentor lost her life to a horrific crime sometime yesterday in Atlanta.

 

Jeanne Calle was a member our Society family since 1989.  She was Vice President of Epidemiology here at our National Home Office in Atlanta.  Just two weeks ago she was feted by her coworkers as she began the next journey in her life, which was marked by her retirement from the Society at the age of 57.  She lost her first husband to cancer several years ago, and recently became engaged to a local attorney.

 

As noted by Dr. John Seffrin, the Society’s chief executive officer, “Jeanne brought a formidable intellect and passion for finding answers to cancer through her research.  We are shocked and deeply saddened by the senseless loss of this tremendously talented friend and colleague.”

 

Those words can only be a small reflection of what Jeanne meant to those of us who knew her and worked with her.

 

You probably didn’t know Jeanne by her name, but you did know her by her work.  She was an epidemiologist who worked incessantly to unlock the secrets of what population-based information can tell us about the causes and risk factors that lead to cancer.  There are few researchers in this country who have labored so hard and been so successful at bridging the gap between what we learn from epidemiology research and how we apply that information to our everyday lives.

 

Jeanne was widely known in her professional community for the outstanding research that she accomplished and published during her too-short life on this earth.  She was one of the lead researchers on a report published several years ago that made the case for the link between obesity and cancer.  But that was one of only many, many articles that she published in collaboration with her colleagues here at the American Cancer Society and elsewhere.

 

Jeanne was instrumental in developing data from our CPS II study, which has monitored over one million healthy people since 1982 to look for those elusive clues that help us understand what increases our risk of cancer.  She was a guiding light in developing and initiating our successor CPS 3 study, which is continuing to recruit volunteers to take these studies forward into the 21st century.

 

Jeanne was more than a scientist.  She was a friend to many, a valued colleague, and a committed mentor.  She constantly challenged those she worked with to get to the truth, to refine and define their arguments, and always put science first and opinion second.  There was never any question about her motivation: she was devoted to the pursuit of excellence in her work and those around her.  Her goals were always much loftier than her personal concerns.

 

We have lost someone very special.  Her death was tragic and needless, and defies explanation.

 

Jeanne Calle was a star in our sky, a sky that tonight and forever more will be missing the brightness of a life so tragically ended.

Filed Under:

Revisiting Off-Label Cancer Drugs In Medicare

by Dr. Len February 17, 2009

No sooner had the ink dried on my blog from last week about the problems controlling the costs and off-label uses of cancer chemotherapy drugs than the Annals of Internal Medicine published three articles and an editorial on the topic of off-label drugs in cancer treatment.

 

And the Annals’ conclusions weren’t any too kind to our current system of determining what drugs Medicare will or will not pay for when it comes to cancer treatment: we are—according to the journal—in a world of hurt.

 

The reason all of this is so important is that many of the newer cancer drugs are very expensive.  In addition, probably a majority of cancer treatments today are already “off-label”, which means the drugs are being used for treating diseases or conditions which were not part of the original approval from the Food and Drug Administration.

 

As I mentioned in last week’s blog on this topic, Medicare relies on books called compendia to determine whether or not they are going to pay for a drug to treat a particular cancer.  These compendia are published by private organizations, each with different approaches to reviews of the evidence and how the data is assessed and presented.

 

In the most detailed of the articles in the Annals, the authors do an in-depth analysis of these compendia to determine whether they provide “comprehensive, research-based, and timely information for off-label prescribing in oncology.”

 

In short—according to the research—they don’t.  The bottom line finding was that these compendia lack transparency as to how they reach their conclusions and do not follow a detailed, systematic approach to review or update the evidence.

 

The result, according to the authors, is essentially a hodge-podge of information and recommendations that may conflict with each other and not reflect our current knowledge about which drugs work for which cancer.

 

A couple of comments from the article:

 

“These compendia have essentially functioned as gatekeepers; it is critical to examine their processes for evidence review, the reliability of the evidence they include, their decision-making pathways for adding new drugs, and their practices with regard to timely updating…

 

“We found little agreement between the results of systematic reviews of 14 off-label indications of cancer drugs and the evidence cited for those indications in these commonly used compendia.  Cited evidence was scanty and inconsistent across compendia, which raises questions about the processes by which evidence is identified and selected to generate recommendations, the potential biases or conflicts of interest that affect decisions of whether to include an indication or how to present the evidence, and the comprehensiveness and quality of the evidence that the compendia include.”

 

I could go on with more quotes, but I suspect you get the idea: the researchers thought there was considerable room for improvement.

 

Two additional articles make recommendations on how to improve the process.

 

One of the articles recommends that the Centers for Medicare and Medicaid Services (which administers the Medicare and Medicaid programs) centralize the decision making process for drug payment approval.  Right now, as noted in last week’s blog, that function is handled for the most part by regional companies that administer the Medicare program.  They are supposed to use the compendia to standardize their decisions for drug payment, but that still leaves room for variation in different parts of the country.

 

In the current paper, the author suggests that we need to have better control over the use of off-label cancer treatments, particularly the newer, more expensive targeted therapies.  To get this control, she suggests that after a drug is approved by the FDA that it undergo a separate review by CMS as to whether or not it is “reasonable and necessary” for the treatment of a particular cancer.

 

Although the author blends the issues of approval for devices as compared to drugs, there is some merit to considering a national coverage decision for chemotherapy drugs under some circumstances, as I suggested last week. (Devices can be approved by the FDA if they are safe, but the FDA does not demand the same level of proof of effectiveness for devices as they do for drugs.  As a result, I agree that it is appropriate for CMS to make payment decisions for medical devices such as defibrillators.  Drugs, on the other hand, have to demonstrate more rigorous evidence of safety and effectiveness for FDA approval, which suggests to me that a separate review of drugs for FDA-approved uses is not necessary.)

 

That said, I think it is unfair to suggest that all off-label uses of cancer chemotherapy drugs need close government scrutiny.  The process could end up being too ponderous to respond efficiently, particularly when evidence of new value for a drug is substantial, such as was the case with Herceptin used in the adjuvant treatment of HER2 positive breast cancer.  Another more recent example is the success of Avastin in treating a highly malignant form of brain cancer.

 

The third article in this series  written by CMS staff details how the compendia make their recommendations, including some of the problems with their processes, such as disclosing conflicts of interest among the decision-making experts who sit on the publications’ panels. 

 

That article concludes that “Congress has provided a broader authority to CMS to pay for anti-cancer chemotherapy drugs that may have indications that the FDA has not approved (or considered) but that compendia have listed as having some benefit.  Given the high stakes involved in cancer chemotherapy, the public should know about the process by which Congress gives compendia the authority to approve specific indications for these drugs.”

 

The editorial in the Annals which accompanied these three articles was blunt and to the point: “In short, the compendia were inconsistent, incomplete, and out-of-date.  (The) findings speak for themselves in making the case for change…In this context, clinical policies for off-label uses of drugs are a throwback to earlier, less rigorous times…

 

“The articles in this issue shine a bright light on a weak point in our efforts to inform clinical practice by the best possible evidence. The present system seems wanting.  We have the tools to do much better.”

 

All of these comments are relevant and important to consider.  Cancer chemotherapy drugs are expensive.  They are frequently used in off-label situations, hopefully more often than not in circumstances that have been vetted through appropriate scientific research.  There are situations where the use of off-label drugs such as erythropoietin (ESAs) have gathered steam and caused harm to patients, unfettered by the lack of FDA oversight.

 

In the interest of full disclosure, the American Cancer Society did support the use of compendia several years ago in a letter to CMS.  The alternative was a non-system, where there was no reasonably current means to address the question of what drugs are effective in a rapidly changing research driven world. 

 

That issue remains relevant today, especially in an era when new drugs and new drug uses are reported regularly—especially at the annual meeting of the American Society of Clinical Oncology.  And some of these drugs are literal lifesavers which can take months to get approval from the FDA. 

 

Just because a cancer drug is used “off-label” is not to say that it is bad medicine.  To suggest otherwise is not appropriate and may even be harmful.

 

In the meantime, what are cancer patients and their doctors supposed to do when clinical trials show that a drug is effective in treating a particular cancer?  Should we require that everyone wait for a detailed evidence analysis before the FDA or CMS can approve these drugs if they are already available?  What do we do as doctors and patients if the evidence is overwhelmingly positive, as was the case with Herceptin?  Do we invoke a system similar to that used in the United Kingdom where women couldn’t receive a drug that saved lives?

 

There is no easy answer to this dilemma and I certainly don’t purport to have all the answers.  Right now, the compendia with all of their faults and warts are the best reference resources that we have. 

 

Maybe we could and should do better.  Inevitably, however, we will need to figure out some process that recognizes we cannot let the perfect be the enemy of the good. 

 

If we don’t have that flexibility—as recent experience has shown us—we run the risk of not providing the best evidence-based care for our patients with cancer that we can offer as quickly as possible.

 

That, too, would be a tragic outcome.

 

 

 

Filed Under:

Cancer Care | Medications | Treatment

Controlling Cancer Chemotherapy Costs in Medicare

by Dr. Len February 13, 2009

An article in a recent issue of the New England Journal of Medicine once again raises the question of how are we going to afford our cancer treatments now and in the years to come?

 

The report, written by Peter Bach MD who is currently on the faculty of Memorial Sloan Kettering Cancer Center in New York and in the recent past served as a special advisor for oncology to the Administrator of the Medicare program, highlights the difficulties that the Medicare program has controlling the increasingly substantial costs of new cancer drugs.

 

As acknowledged in the article, we have made advances in the treatment of advanced cancers, such as colorectal cancer.  But these advances have come at huge costs.

 

For example, the costs to Medicare of injectable cancer drugs given in doctors’ offices increased from $3 billion in 1997 to $11 billion in 2004, an increase of 267% at a time when the costs for the entire Medicare program increased  47% (which itself is not exactly chump change).

 

Dr. Bach goes into great detail about how Medicare could control  chemotherapy drug costs, such as only paying for the least expensive effective drug, or averaging out the costs of drugs that are similar.  But he also points out that the newer cancer drugs are “sole source” for specific diseases, which essentially means that Medicare must pay the costs for whatever drugs the doctor chooses.

 

The article also comments on the huge reduction in Medicare expenses that occurred when the off-label use of ESAs—which are drugs used by medical and radiation oncologists to increase the red blood cell counts of patients either undergoing active treatment or if they have anemia related to their disease process alone—was found to actually cause harm to patients.  The net result was that use of these drugs quickly dropped and the costs to Medicare dropped from over $1 billion a year to just $200 million.

 

What Dr. Bach did not point out was that these drugs—which are for supportive care, not the active treatment of cancer—were the leaders in outpatient drug costs for cancer patients in the Medicare program.  You would have been wrong until recently if you thought that typical chemotherapy drugs led the pack when it came to Part B Medicare chemotherapy expenses.  In fact, it was the ESAs.

 

The article does review several of the options available to the Medicare program to control costs, such as bundling all the charges for cancer care into a single payment and let doctors and patients decide how to best spend that money.  Another would be to fund a comparative effectiveness program to assess whether or not these newer treatments (based for the most part on targeted therapies) are really better than older treatments.

 

And, then, there is always the possibility that Medicare could be given responsibility to determine which treatments are acceptable, based on cost-effectiveness criteria.

 

None of these options is particularly appealing to doctors and patients, who in the United States have been generally unencumbered by financial constraints in making cancer treatment decisions if the patients have excellent insurance and unlimited finances.

 

For the rest of us, decisions about what cancer treatments we actually use are being made every day across the country based on whether or not people can afford the drugs.  Some people simply don’t have any insurance, others have inadequate insurance, and those who thought they had enough insurance find out quickly that they have outspent the limits of their health insurance policy.  And few have the additional savings to pay for the high deductible and co-pay costs of these drugs.

 

There are some additional points that should be considered in this analysis, some of which are unique to the Medicare program and some that are broadly applicable to insurance in general.  All reflect the difficulties we face as a nation going forward as we seek to craft solutions for this very vexing problem.

 

For example, you probably think that cancer drugs used for Medicare patients are “approved” for payment by a central Medicare office based on a detailed analysis of their effectiveness for a particular cancer treatment regimen.

 

Well, that is not the case.  Many of the decisions made to cover medical procedures and treatments for Medicare patients are made by companies around the country that have contracts to administer the Medicare program in different locations.  These companies used to be regional and fairly large in number.  Over the past number of years, there has been consolidation in these carriers and some of them are no longer regional but may cover many different states, even in different parts of the country.

 

These “local medical review policies” have the potential to create different rules in different parts of the country as to what drugs and procedures will be covered for some Medicare patients and not covered for others.  Instead of this catch-as-catch can approach to cancer treatment, some experts have recommended—especially for very expensive cancer treatment drugs—that the coverage decisions be made centrally rather than locally. 

 

I’m not going to comment on which approach is better—there are arguments on both sides of this one—but only say that we must have consistency in the decision-making process when it comes to cancer treatments.  There is simply too much at stake.

 

Recently, Medicare has decided to use four resources called compendia to determine which drugs cancer drugs should be covered for payment.   These are the guides that the regional/national carriers are now supposed to use to make these coverage decisions.

 

The reason this is so important is because many of the drugs used in treating cancer are “off-label.” That means they were not evaluated or approved by the FDA to be used as they are today in various combinations or doses for the treatment of a particular cancer.

 

The problem is that much valid cancer treatment which is state-of-the-art and perfectly appropriate is “off-label.”  The compendia are supposed to evaluate these off-label uses and keep the data up-to-date so that patients aren’t denied access to necessary and appropriate treatment.  (Why the drug companies don’t seek these additional approvals from the FDA is a topic for another day.)

 

But what happens when a lot of the use of a particular drug used in treating cancer patients for a particular disease or condition—such as ESAs in the anemia of cancer, which led to premature deaths—is beyond FDA oversight and approval?  How do we find out whether those treatments are in fact acceptably safe and effective?

 

Maybe what we need to do is continue to monitor these drugs and how they are used after approval, and if there is a significant increase in off-label usage perhaps they should be reviewed through some process that can in fact evaluate their effectiveness and safety. 

 

If we don’t do something to keep an arm around off-label use to be sure there is some rationale to use a particular drug to treat a particular patient with a particular cancer-- especially with very expensive targeted therapies-- then the money will run out while we offer treatments to patients that have no basis in science and little expectation of meaningful success.

 

Another interesting point is that the Medicare part B program—which is where the payments for chemotherapy drugs given in the doctors’ offices come from along with payments for physician services and durable medical equipment—is “budget neutral.”

 

“Budget neutral” means that if money needed to pay for expensive cancer drugs and other outpatient medicines under Part B goes up, then payment for something else in Part B must go down. 

 

Where does that money come from?  It comes from payments to doctors for services to Medicare patients.

 

Because of these budget neutrality rules—which are supposed to be very strict but in fact have been “broken” by Congress every year for the past several years—payments to physicians are projected to decline 21% beginning January 2010.  That in turn will impact access to care for Medicare patients. 

 

Already in my hometown in Southwest Georgia no primary care internist or family physician will take a new Medicare patient.  And this is a community that has been touted in several magazines recently as a desirable place to retire, in part because of its high quality medical care.  If these proposed cuts go into place, there is a virtual certainty in my personal opinion that access problems for Medicare patients are going to increase dramatically nationwide.

 

The costs of chemotherapy drugs in the Medicare program are not solely responsible for the problem of finding a primary care physician in Thomasville, Georgia.  But this is an example of how so many of these seemingly unrelated issues are in fact intertwined, not only in Medicare but in Medicaid and private insurance as well.

 

The complexities of Medicare drug costs are simply a metaphor for what we face as a nation when it comes to the costs of medical care.  The net result is that we need to take a hard look at how we are going to solve the problems of access to quality, affordable medical care in this country, a cause that has been vigorously championed by the American Cancer Society.

 

This is not something that is going to be solved by waving a magic wand and hoping it will go away.  It will take hard work and hard compromises to find solutions that are equitable for all. 

 

Yes, there are momentary urgencies that require our immediate attention, but we cannot ignore our responsibilities to address this fundamental and very necessary issue. 

 

Filed Under:

Medicare | Medications | Treatment

Your Insurance Can Disappear When Cancer Strikes

by Dr. Len February 05, 2009

You work hard, take good care of your family, and although of modest means you manage to put up a couple of dollars for your retirement.  You do all the right things for your health, including avoiding tobacco, eating a healthy diet and getting recommended cancer screenings.

 

And then one day you wake up and feel a lump in your neck.  You make an appointment to see your doctor, and after a number of tests and biopsies you get the news no one wants to hear: you have an aggressive form of lymphoma and will require extensive treatment that has a reasonable chance of saving your life.

 

You are beginning a journey that no one chooses to take, but you commit to doing everything you can to get well.   And then you start getting the bills, wondering what happened to that health insurance you pay for at work?

 

That’s when many folks just like you find out the grim news: your insurance isn’t enough to pay the medical bills for your lifesaving medical care.  Your savings are gone, your retirement is gone, and you don’t know where to turn.

 

That is, unfortunately, not an unusual story as borne out in a detailed report on cancer and health insurance released today by the American Cancer Society and the Kaiser Family Foundation.

 

The report, “Spending To Survive: Cancer Patients Confront Holes in the Health Insurance System”, details the real life stories of people like you and me who contacted the American Cancer Society through our National Cancer Information Center hotline desperate for help in paying their medical bills.

 

For the majority, the Society was able to do something to get them assistance, but for many there was no place to turn.

 

The report also goes into great detail—in clear and understandable language—about the problems many cancer patients and their families face in paying for the not-infrequently catastrophic costs of cancer care.  It explains how people get to where they are when it comes to paying their medical bills.  It describes the options and barriers to dealing with these unexpected events that can play havoc with even the best of us who try to prepare for the unexpected in our lives.

 

What is clear from this report is that we must confront this issue now.  The frequently invoked “safety net” for those facing serious illness simply isn’t there. 

 

As a doctor, I have long believed that the “safety net” for the most part doesn’t exist for many of us.  You can’t get cancer care in an emergency room, and even the best intentioned physician can’t survive for long in an oncology practice by providing expensive drugs without getting reimbursed.

 

Medicaid isn’t the answer until you spend everything you have.  I doubt that many of you—all decent people who mean to do well and not be a burden to anyone—would want to willingly dive into the morass of Medicaid and the absolute spend down that you must complete before being eligible for assistance.

 

As the report also points out, most of us who lose jobs can’t afford to purchase health insurance from our former employers under COBRA plans, especially if we stop working because of a sudden, unexpected serious illness.  It is simply too expensive.

 

And if you become disabled with a diagnosis of cancer, Medicare doesn’t become an option for at least two years after you are determined to be eligible.  (Although, as previously noted in this blog, the Social Security Administration has recently reduced the waiting period for Social Security disability payments for patients with certain cancer diagnoses resulting in quicker disability benefits.  Unfortunately, the Commissioner doesn’t have the authority to do the same thing for the Medicare waiting period.).

 

State-based high risk insurance pools also aren’t the answer for many patients as noted in the report.  Again, they are very expensive, and the various co-pays and deductibles are nothing to sneeze out, especially when the annual costs of some cancer chemotherapy drugs and treatment costs run into multiples of $100,000.

 

So what do we do? 

 

I certainly don’t have the answers, but it would seem to me and many of my colleagues that sitting on our hands or otherwise ignoring the problem is going to make this issue go away.

 

I believe it is important to emphasize that we aren’t talking about handouts here, or individual bailouts for that matter.  We are talking about all of us and all of our families. 

 

Many of us are one step away from financial and insurance disaster if we are diagnosed with cancer.  I suspect there aren’t a lot of our fellow citizens out there who are so emotionally and politically cold that they can’t understand the dynamics of this issue.  Solving this problem is core it is to our sensibility and humanity as a nation.

 

There are no easy answers, and there will be no easy answers when it comes to solving the problems related to access to health care.  Granted, economic realities have superseded many other political and social issues these days.  But this is one reality that isn’t going to solve itself. 

 

Take a couple of minutes and read the report, look at the photos, and think about the stories.  I suspect that you will then agree with me, the American Cancer Society, the Kaiser Family Foundation and many others that resolving the health insurance dilemma deserves our full attention and the sooner the better.

 

 

 

Filed Under:

Cancer Care | Medicare | Treatment

World Cancer Day: A Focus On Childhood Obesity

by Dr. Len February 04, 2009

Cancer is a worldwide disease, and in recognition of that fact the International Union Against Cancer (UICC) has designated today as World Cancer Day. What’s interesting about this is the theme they have designated for their next year’s focus: “I love my healthy active childhood.” 

 

Why, you might ask, is a leading international cancer organization choosing to emphasize children and obesity as a target for this campaign?

 

I think many of us tend to underestimate cancer as a global health issue.  Poverty, education, and limited financial resources make cancer a much different disease in many parts of the world, particularly in underdeveloped economies.  The sad truth is that many people in underdeveloped countries don’t live long enough to develop cancer.  And those that do all too often simply don’t have access to effective treatments, even those we take for granted such as chemotherapy and radiation therapy.

 

What we take for granted—including prevention and treatment, such as mammograms, colonoscopy, and pap smears—are essentially luxuries in too many countries.  Tobacco use is on the increase internationally, and millions worldwide will die from tobacco related diseases in the coming decades.  The spread of this scourge—due in no small part to companies based or started here in the United States—is happening just as we are seeing decreasing disease and deaths from tobacco as we stop smoking.

 

But there is another interesting dynamic going on throughout the world that is in no small part due to our culture influencing both developed and underdeveloped countries: we are also sending our very unhealthy eating styles to all parts of the globe.

 

The net result is an increase in obesity, especially among children.  And that explains why the UICC has decided to focus on obesity in children as part of a larger cancer awareness campaign.

 

We know—as I have often recited in the pages of this blog—what we can do to significantly reduce our burden of suffering from cancer: avoid tobacco (either directly or indirectly), eat a health diet, maintain a healthy body weight, engage in physical activity on a regular basis, and follow the American Cancer Society guidelines for the prevention and early detection of cancer.

 

Unfortunately, when it comes to our diet, too many of us aren’t doing such a good job. 

 

The net result has been a significant increase in overweight and obesity in this country and elsewhere, in places far and wide.  And that, my friends, means not only more heart disease, diabetes, hypertension and strokes, but also an increase in the number of many cancers as well.

 

Surveys have been done in the United States that show very few of us are aware that there is a link between our weight and our risk of cancer. 

 

As part of the UICC campaign, they did an international survey on awareness regarding the relationship between obesity and cancer risk and found that 40% of the people in the Americas, western Asia and Australia and New Zealand were not aware of this risk.  As reported by the UICC, even more people in other countries did not know about this relationship.

 

But here are the more staggering numbers from their survey and calculations: an estimated 22 million children around the world are overweight or obese right now.  And, according to the UICC, 3 to 4 million new cancer cases could be prevented every year by reducing overweight and obesity.  That is a truly impressive number.

 

The UICC is correct in noting that we develop our eating habits (and many other habits and behaviors) during childhood, so the place to really start influencing our health begins when we are young.  Thus, the reason for this year’s campaign.

 

The American Cancer Society is fully supportive of this new initiative.  Our Chief Executive Officer, Dr. John Seffrin—who recently served as President of the UICC—noted that ten percent of school-age children in the world are overweight, including up to 45 million who are classified as obese.

 

Dr. Seffrin emphasized in his remarks about the UICC campaign that organizations like the UICC and the American Cancer Society need to make it possible for everyone to develop good habits and carry them into adulthood.  The inevitable benefit will be better health, and fewer deaths from cancer.

 

As the oft-quoted statement reminds us, it takes a village to provide support for all of us to do what we need to do.

 

When it comes to decreasing the burden of cancer through developing healthy habits and reducing our risk of cancer and other diseases, we now know it clearly takes a world.

Filed Under:

Diet | Exercise | Prevention

About Dr. Len

Dr. Len

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

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