There is an article on the front page of this morning’s Wall Street Journal describing the experiences of a Texas woman diagnosed with acute leukemia who had to come up with hundreds of thousands of dollars before she could be treated for her life-threatening disease.

The basic premise of the article is that hospitals are no longer going to treat first and bill later.  The rising number of uninsured patients and those who do not pay their bills is reportedly creating an increasingly severe burden on non-profit hospitals, which in the past would have absorbed the costs.

I can’t say that I am surprised that this is going on.  I am surprised that it has taken so long for the issue to get attention.

The costs of cancer treatment are escalating, in some cases--such as with the newer targeted therapies—substantially.

For example, based on some preliminary data that I have seen recently, the Medicare Part B program experienced a 36% increase in expenditures for bevacizumab (Avastin) from 2006 to 2007.  This drug is widely used in the treatment of an increasing number of cancers (it was recently approved, for example in the treatment of advanced breast cancer).  The actual numbers went from $456 million in 2006 to $621 million in 2007.  This was in the face of a decreasing number of Medicare part B beneficiaries.

Other new drugs had similar large increases in costs to the Medicare program year over year.  For one drug, natalizumab (Tysabri, which is used in the treatment of multiple sclerosis), although the numbers were smaller in absolute terms, the relative increase in cost to Medicare went up almost 800% year over year.

On the other hand, because of increased concerns and scrutiny of ESAs—which are drugs used to increase red blood cell counts in patients with cancer—Part B Medicare payments for these drugs decreased from $1.79 billion in 2006 to $1.47 billion, or about 18%, from 2006 to 2007.

(If there is any good news here, it is that the increase in costs of chemotherapy in the Medicare program “only “ went up $1.9 billion from 2006 to 2007 compared to an increase of $2 billion from 2205 to 2006.  But that doesn’t take into account the decline in the number of beneficiaries who have transferred out of part B to Medicare Advantage HMO programs.)

These are big numbers, but more importantly, these are costs that are much less easy for hospitals and doctors to ignore, since they have to pay for the drug themselves before they can give it to a patient.

At hundreds of thousands of dollars of out-of-pocket costs, it doesn’t take long for a hospital or doctor to become much more concerned about their unreimbursed costs of care.

Health care professionals have always given their time for charitable care.  However, as the demands for charity increase or people don’t have any health insurance or that insurance is inadequate, the margins available from other patients who pay for their services are decreasing, in no small part because of declining Medicare payments and managed care contracts. 

If people decide they don’t want to pay a medical bill—maybe they don’t have the money, or maybe they think the charge is outrageous (as may be the case with the $20 pair of latex gloves described in the WSJ article), or maybe they just don’t want to pay for their own reasons—then there is less opportunity for those who depend on those payments to extend charity.

But when it comes to handing out expensive drugs with no or little chance someone is going to pay for those drugs, then the doctor or the hospital really have to question whether that is something than can afford to do.  The expected reaction may well end up being the type of situation described in today’s newspaper article.

I am not here to make the judgments as to who is right and who is wrong.  You can read the facts and come to your own conclusions.

What I do want to highlight is the fundamental issue, namely that we are going to see more and more circumstances where patients are going to have to quickly come up with large amounts of money on a moments notice to get care.  The good old days are gone.

The best example in the article of how radically things have changed was the description of how the blocks and barriers were put into place for the patient before she could get an office visit with her doctor, or even during the midst of her receiving chemotherapy. 

Personally, I can’t imagine being in the situation described in the article where a chemotherapy infusion was started and then interrupted until the patient or her family went to the finance office to pay the bill. 

When I was in practice a number of years ago, it would have been unthinkable for a financial/billing representative to enter a patient’s examining room with me to first confront the patient about her bill before I could discuss her medical needs.

I am not saying these are not important issues.  They are.  But they don’t belong in the examining room or the treatment room.  My advice: move it outside.

But that won’t make the problems go away. 

Drugs are expensive.  Wages—especially for nurses and other specialized health care professionals who are in increasingly short supply while demand continues to expand—are rising.  Malpractice insurance is high.  Maintaining the buildings, sophisticated medical equipment and information technology which are necessary for today’s modern medical practice are all expensive.

What concerns me is that I am not aware of anyone who is looking at this issue on a nationwide, comprehensive basis. 

In my personal opinion, it is shameful that we do not have accurate, objective, community-based information on how patients, doctors and hospitals are dealing with the issues of cost in cancer care.

Are insurers covering these new drugs?  Are Medicaid programs providing adequate coverage?   Are people able to get access to evidence-based, effective cancer care?  How are they coping with the high costs of targeted therapies?  Are they making trade-offs with their lives because they can’t afford care?

If you think this is a problem for poor people, think again. 

Take a close look at your health insurance—especially the chemotherapy and drug benefits—as well as your financial assets and see if you could afford thousands of dollars out of pocket tomorrow if you were diagnosed with an illness such as acute leukemia which requires immediate, intensive treatment to save your life.  

These are not common illnesses, but they do occur.  And the treatments and the payments won’t wait for you to sell your assets such as investment properties, especially in a market where the value of those assets have diminished considerably.

My friends, I hate to say this, but I suspect many of you are ignorant of the financial risks you face when it comes to getting treated for cancer. 

You are employed and you rely on your insurance, but you probably have no idea of the deductibles and co-payments, or the limits that have been put into place on the maximum amounts that will be paid for chemotherapy or perhaps radiation therapy.  Or you don’t know that the co-pay for your blood pressure medicine is $15, but for chemotherapy is 25%--which amounts to thousands and thousands of dollars.  Or your lifetime total benefit is $1M, a number which disappears quickly if you have a serious cancer that becomes chronic with remissions and relapses requiring expensive treatments over the course of several years.

My bet is that you are closer to the situation described in today’s Wall Street Journal than you realize, and there will be no safety net to catch you.

You may be a wonderful person, with a wonderful family, who has worked hard your entire life.  You have paid off your home, and saved some money.  But, if current trends continue, no one will take that into account if you can’t come up with the co-payment or additional money for the costs of care not paid for by your insurance.  Hospitals and doctors will be forced into situations where “Mr. Nice Guy” no longer applies.

If you haven’t been sick, then you probably don’t know that the safety net isn’t there anymore.

I had a conversation this past weekend with a physician colleague where we discussed our concerns about the rapidly increasing costs of medical care.  Both of us have been involved in physician payment issues for many years, always trying to do the right thing to make certain that the payment structure made sense and was reasonable.

The conversation shifted to the costs of care, and how people can afford to pay their medical bills.

My colleague’s statement (which echoed my own thoughts) was a profound commentary on the times, when he said, “It is no longer whether THEY can afford to pay for medical care.  Now WE have to worry how we can pay for our medical care.”

My friends, when the doctors—who are obviously as a group economically well-off and usually have excellent health insurance--start worrying about having enough money to pay for their care, then you know we are all in serious trouble.

There is a quiet, early revolution going on in medicine.  We are beginning to redefine how we provide primary care, moving from a traditional “one on one” patient/doctor relationship to a new model which emphasizes a medical team providing patient focused care.

The name of this new model of care is usually referred to as a “patient centered medical home,” or some variation of those words.  The impact of this change—which will take years to better define much less accomplish—has the potential to be enormous and transformational.

If done right, this effort has the potential to vastly improve the care we provide our patients, emphasizing prevention as well as more effective, evidence-based primary care medicine when someone develops an illness or a chronic medical condition such as diabetes or heart disease.

In my personal opinion, we have the most technologically advanced medical care system in the world.  What we don’t have is the most effective medical care system, based on a variety of measures.  We can provide excellent care, but there is no systematic way to evaluate what we do, there is no way to get needed preventive services to those who need them, and too many people have either no access to medical care, have inadequate access, or can’t afford to get the care they need.

Otis Brawley, MD—who is the American Cancer Society’s Chief Medical Officer—has a slide that he uses in his lectures on access to care which shows the average life expectancy in many countries around the world.  Superimposed on this data is another line which shows the relative costs of medical care in those same countries.

What you see on that slide would probably startle many of you:  Yes, there is a relationship between life span and the amount of money spent on medical care.  In those countries that spend larger amounts, life expectancy is longer—with one glaring exception: the United States.

The countries with the longest life expectancy are on the left side of the graph.  Down towards the right end of the same graph sits the United States.  Yes, our life expectancy is significantly lower than many other countries on this planet.  But the cost line goes way, way up for the United States—higher than any other country in the world.

We spend a whole lot of money providing medical care in this country, but our life expectancy is less than many others including some of which many would consider economically much poorer and much less developed than the United States.

Something simply doesn’t make sense.  We spend money, but don’t improve the quality of care for our citizens or their quality of life, or the length of their years.

These aren’t new concerns, but there is now a growing realization that our medical care non-system is seriously overloaded with specialist physicians and grossly inadequate when it comes to having enough physicians and related health professionals providing primary care. 

We know that having a relationship with a regular source of primary care leads to better outcomes.  We know that where there are more specialists practicing medicine, the costs of medical care are higher and the outcomes no better.

We also know that new doctors don’t want to become primary care physicians.  Those that practice primary care are getting older and rapidly retiring.  In many places—including my home town in southwest Georgia--primary care practices are limiting the number of new Medicare patients they take into their practice (or not taking any new patients at all) since they can’t find more primary care doctors, nurse practitioners and physician assistants to fill the need.

In some locations, “concierge” primary care practices are becoming the next new thing, where patients pay large retainers to doctors for access to the practice.  Most patients can’t afford these fees, so effectively there are fewer opportunities in some communities to get primary care unless you happen to be reasonably well-off financially.

Primary care isn’t viewed as “glamorous” by young doctors and many of my medical colleagues compared to some other specialties, and the economics of practice don’t work.  Bottom line, when a young medical student looks at a future career they see that many of the considerations that influence their professional career choices—such as income and life style--weigh heavily in favor of specialty medicine as opposed to primary care.

The net result is that as our population gets older, we have fewer and fewer primary care physicians to care for them.

There are a variety of solutions that have been proposed or have moved forward to address this issue.  Clinics in stores staffed by nurses is one approach.  Using more nurses and physician assistants in doctors’ offices is another.

A couple of years ago, several leading medical professional societies including the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics and the American Osteopathic Association proposed a new model of medical care delivery.

The approach would be patient centered and focused, team oriented, and provide a true holistic approach to primary care.  Prevention would be a primary focus, trying to prevent illness before the ravages of obesity, hypertension, diabetes and heart disease would take hold.  Care would be coordinated with specialists, and no longer would patients wonder who is in charge when they get sick.  We would move to an electronic-based system, so we could monitor the health of populations of patients, as opposed to the current patchwork approach used in most primary and specialty medical care practices.

What has happened subsequently is that this model has moved from the theoretical to the development stage.  The medical societies have continued to increase awareness of the concept, and gather support from numerous sources.  Insurers and foundations are funding patient centered medical home demonstration projects around the country.

Congress has passed legislation directing Medicare to develop a primary care medical home demonstration project.  For the past several months, I have been part of a committee that has been working with Medicare to define the medical home services, and make our best estimate of how much it will cost to provide those services. This demonstration project will likely move forward in the next several months.

Several large medical groups around the country have already implemented the medical home model, using teams of doctors, nurses, social workers and others to take care of their patients.  They have installed needed technology support including advanced electronic medical records.  They have regular care conferences with the medical team and families as appropriate, and carefully evaluate what they do and how they do it.  They have applied the holistic principles and global approach needed to make the medical home a success.

This transformation is not going to be an easy process, and is likely going to take years if not more than a decade to accomplish.  Change in well established medical care patterns are going to be difficult to alter. 

That has always been the case in medicine.  Change takes a long time to accomplish in my profession. But that should not deter us from our goal of making our medical care system truly a medical care system.

No one knows whether or not we are going to save money doing this. That should not be the ultimate goal, but it certainly wouldn’t hurt. 

If we could coordinate medical care, make certain patients take the medicines they are prescribed, encourage patients to get preventive medical care and provide a place they can go to for not only visits but also education on how they can better care for themselves, then we would accomplish a great deal.  The investment would pay for itself many times over in many ways, including economically and personally.

Ultimately, however, it’s the outcomes that count. 

It has been my dream for years that we could somehow get this thing we call medical care “right”: The right care for the right person in the right place at the right time at the right cost.

It would especially rewarding in years to come if we were able to see the United States’ life expectancy move up the scale on Dr. Brawley’s slide.  Maybe we might even see the cost comparison line come down a bit.

It is going to take a lot of effort on the part of a lot of people to get where we need to go when it comes to improving primary care in this country.

As a realist, I also know this is not going to be easy.  As an optimist, I will bet on success. 

If you want to understand why some of us are concerned about conflicts of interest, you need go no further than an article that appeared in last Friday’s edition of the Cancer Letter.

The article, written by Paul Goldberg, goes into great detail to explain why a scientific review on vitamin D, sun exposure and tanning booths which appeared in the New England Journal of Medicine last July may have been influenced by tanning industry funding.

The fallout from this conflict, in my opinion, may have substantial negative impact on how we are able to regulate tanning bed use, especially among young women who are putting their health at risk from the adverse effects of articial tanning.

The story is not new to regular readers of this blog.  I covered it in July 2007 when the review article first appeared in the New England Journal.

Essentially, the article was a review article on vitamin D and its potential role in health and disease.  As I noted at that time and on many occasions subsequently, I admired the depth of the science in the report regarding vitamin D and how it relates to human health.

Where I had a problem was that the author, who is widely known to be supported by and supportive of the indoor tanning industry, failed to make any comment in the article about the potential harms and risks of his recommendation that we should get regular sun exposure to get adequate amounts of vitamin D.  He also recommended tanning salons as an effective and safe means of getting vitamin D.

What he didn’t do was comment on the fact that there are many well-qualified experts in this field who disagree with his recommendations.  These experts don’t dispute the need to better understand vitamin D as it applies to our population, or that there is a role for vitamin D as part of being healthy.  The evidence is strong that vitamin D plays a role in muscle and bone health.  There is evidence that suggests vitamin D may play a role in cancer prevention. 

These experts feel that the recommendations for sun exposure and using tanning salons to increase vitamin D levels in our bodies do not take into account the risks of skin cancer that would result.  Nor do these recommendations take into consideration the realities that we are all different in where we live, the color of our skin, and our individual sensitivity to sun.  All of these factors and others influence our sensitivity to sun and how much vitamin D we produce in our bodies from sun exposure.

These experts feel that there is a safe alternative to get vitamin D into our bodies, either through our diets (which admittedly is difficult to accomplish) or through inexpensive, safe dietary supplements which are available at virtually every supermarket, drug stores and many other retail outlets throughout the country.

The Cancer Letter article makes the same points I did in my blog last July, and expands in greater detail to show how a conflict that is not recognized or declared can influence a host of subsequent events.

Basically, what happened in the New England Journal article was that the author acknowledged his research was supported by the Ultraviolet Foundation.

Google the Ultraviolet Foundation and its tax filings and you find out that it is funded by the Indoor Tanning Association. 

And that is not a conflict that should be considered in editing or publishing an article on vitamin D and health?

The Cancer Letter notes that the amount of support in question is small when viewed as a totality of the research support for the author.  But it was significant enough in this circumstance to be noted as a source of funding for the research that led to the publication of the article.

One needs to take a look at what I call “second level effects” of such events.

Maybe the author and the New England Journal consider the conflict of interest to be immaterial.   The potential fallout and damage is not.

Here is a possible scenario of how these things play out, and what in fact is happening right now:

The New England Journal of Medicine is one of—if not the—finest and most highly regarded medical journals in the world.  It is viewed as an authoritative source of medical information, and its influence in scientific, medical and legislative arenas is without peer.

As a result, having research published in the New England Journal provides a widely accepted “stamp of approval” on the research reported, or the information provided in a review article.

Since the editors and reviewers of the article did not see any reason for the author to address the concerns of many experts regarding the risks of tanning and sun exposure—even a sentence or two would have been sufficient—the article stands alone as a firm recommendation on the value of sun exposure and tanning beds as a means of getting vitamin D into our bodies.  (I should note that supplements were also offered as an option.  I am concentrating here on the absence of comment by the author on the risks of tanning beds and sun exposure.)

There are a number of states that are considering or have implemented legislation and regulation of tanning bed use, particularly by young women who represent a population at risk that use these services.

If you have watched legislation and public policy being formulated and debated, you know it is not always a pretty process.  It is usually not very deliberative—legislators always have many items on their agendas, and too little time to do much independent research or investigation.

That’s where this article comes in.  

An article in a prestigious medical journal which makes positive comments about tanning booths is invaluable when lobbying legislators. What could be more authoritative in making the case that effective regulation of this potentially life-threatening device is unnecessary? 

Now maybe you can appreciate why I am so concerned about this particular conflict of interest.

This scenario is not so far fetched. 

The Indoor Tanning Association has embarked on a nationwide advertising campaign to influence people--including state legislators--that tanning is safe, and actually healthy for you. 

Unfortunately, I can’t link to a copy of an ad which recently appeared in the New York Times.  What you see, in large print, is the statement, “Tanning Causes Melanoma.”  Superimposed over that is a “stamp” that says, in bold letters, “HYPE.”  At the bottom of the ad is a link to a website called “SunlightScam.com.”

Although I can’t find much in the way of true scientifically valid supportive evidence on the website, I can’t help but think somewhere someone is using the New England Journal article to support the claims of “hype” and “scam.”

Maybe I am moving with the wrong crowd on this one. 

My problem is that the experts I rely on don’t think that the claims of increased risk of skin cancer and melanoma are a hype or scam.  They do acknowledge that not all melanoma is caused by sun exposure, but they do note that sunburns in youth are a major risk factor for melanoma later in life.  And ultraviolet light—definitely UVB and quite possibly UVA—are the major risk factor for skin cancer.  Skin cancer is not always “benign”.  It can be fatal (melanoma) or very disfiguring when treated (squamous cell and basal cell carcinomas).

Perhaps you can now appreciate why understanding conflicts of interest are important, and that they are not trivial.  Many of us involved in medical science and medical leadership have conflicts.  They are almost unavoidable.

It’s not the conflicts that are always the problem (although in an increasing number of circumstances, they are in fact problematic).  It’s the recognition of the conflict, the declaration of the conflict, and the mitigation of the conflict that offer us the best hope to enable us to continue to maintain our trust in our most valued institutions, researchers, and leaders in medicine.

As I have said recently in another blog, it is up to the professions to deal with conflicts of interest issues and give them the visibility they deserve. 

Only through awareness, discussion and full disclosure will we be able to move forward and maintain the trust that the public has vested in us as physicians and medical scientists.

The headline on the CBSNews.com website is loud and clear: “The Kanzius Machine: A Cancer Cure?”

The story goes on to promote an interview which is being broadcast this Sunday night on 60 Minutes.  The interviewer is Lesley Stahl, and the interviewee is John Kanzius.

Mr. Kanzius’ story is an interesting one.  According to various news stories, Mr. Kanzius has terminal leukemia, which has been under treatment for six years.  His experience with his disease and his treatments has focused him on developing a treatment for cancer that will be more effective and less toxic.

Unfortunately, in my opinion, the headline is terribly misleading for patients whose lives may be hanging in the balance.

Mr. Kanzius is not a cancer researcher; he’s a retired TV engineer and inventor. His other invention of note was the discovery that exposing salt water to radiowaves resulted in a flame and the production of heat.  Even Mr. Kanzius admitted the process could not be considered an effective energy source, since it took far more energy to produce the radiowaves than was produced by the burning salt water.  Still, the news media could not resist suggesting that this approach could someday be an alternative for fossil fuels. (http://www.youtube.com/watch?v=aGg0ATfoBgo)

Mr. Kanzius’ cancer invention was to realize that if you exposed ultra small carbon tubes called “single-walled carbon nanotubes,” or SWNTs, to external radiofrequency waves, you could basically heat them up inside a cell, and effectively kill the cell.  This could possibly be a treatment for cancer in humans, if one could figure out how to effectively get these small tubes into cancer cells while not having them taken up by otherwise normal cells.

So far so good.  Many investigators have been looking at the properties of nanoparticles as part of cancer research.  Investigators, some who are now working with Mr. Kanzius, have been using other approaches, such as using gold particles instead of carbon tubes to kill cancer cells using radiofrequency waves. The American Cancer Society’s journal Cancer recently published a research paper co-authored by Mr. Kanzius, in which MD Anderson researchers used the technology to kill cancer cells in laboratory cell culture dishes. The researchers also reported that they were able to kill transplanted tumors in the livers of rabbits using the same approach.

I first heard about Mr. Kanzius’ experiments when I was interviewed by several newspapers around the time of the publication in Cancer, with reporters asking what the impact of this treatment would be.  Those reports also noted that desperate cancer patients were calling Mr. Kanzius for help, although they didn’t mention what advice was offered.

I am even aware of people who have insisted that Mr. Kanzius’ research is so close to producing a cure for cancer that they want all of their donated money directed to his effort.

All of that is well and good, and the story is one that should be told. 

However, as with the burning salt water, there is more than a little oversimplifying going on in any reporting that would suggest that that this research is moments away from producing spectacular results for many patients with cancer.  It’s the false hope thing that has me concerned—as it has from the days I started my practice as an oncologist 30 years and saw the impact of false hope and dashed hopes on the faces of my patients time and again.

When a headline from a major, respected news organization shouts “Cure,” all of us need to stop  and take a breath.

Here is what Mr. Kanzius and the cancer researchers had to say in the Cancer article:

“Our results demonstrate that SWNTs can be used as a therapeutic agent to treat malignant tumors through RF-induced thermoablation, not just as a vector for the delivery of anticancer agents.”

They concluded their article by noting, “The results of the current study strongly suggest that the development of targeted delivery of SWNTs to malignant cells in vitro and in preclinical models should be investigated rigorously to determine whether there is a role for noninvasive RF treatment to effect thermal destruction of malignant cells.”

It is my opinion that what the researchers wrote in that article is directly on target.

We are not aware of any additional more recent published reports on the use of carbon nanotubules and radiofrequency to treat cancer by the research team that wrote the initial scientific paper. 

What frequently gets lost in translation is the immense amount of research that has to be done, and the level of difficulty of that research, before something can be translated from the lab to the bedside of the patient.

For example, there are several approaches currently that use radiofrequency waves to destroy cancerous tumors in various parts of the body, including the liver.  The difference is that the doctors have to insert probes into the tumors, heat up the tumor, and possibly cause damage to the surrounding liver.

With the carbon particles, we still have to figure out how to get the tubes into the tumors and what will happen to the body when the radiofrequency waves are applied.  Although the rabbit experiments used direct carbon particle injections into the tumors, and although needles don’t have to be put into the tumors to heat them up (since they use a radiowave source outside the body), and although the experiments did not show damage to the normal liver in the rabbits, I promise you it is a huge step to take that approach from treating a rabbit liver with a transplanted tumor to a human being with extensive cancer.

Another alternative would be to coat the tubes in some way and inject them into the blood, and hope they hone in on the cancer.  There are ways that may be accomplished, but it is difficult to take that thought from theory to practice.

Last year around this time the world became suddenly very excited about a research report using an off-the-shelf chemical called DCA to treat cancer cells in culture dishes, and effectively treat tumors in animals.  There were millions of internet exchanges, worldwide publications, and many patients who thought a cure for their cancer was at hand.  

I reported on this development on my blog, and you can read the comments for yourself. 

I wasn’t flattering about the immediate treatment potential of this approach and suggested once again that there was additional work to be done before the first patient could be treated with DCA.  That didn’t stop many patients from seeking DCA for their cancer.  Testimonial websites abounded, but you don’t hear much about DCA any more.

I will say the same thing here that I have said many times before:

We see many experiments that work in the laboratory that have the potential to help reduce the burden and suffering from cancer.

Unfortunately, very few of these translate effectively into the clinic.  The sad fact is that during my own lifetime I have seen several manias that have resulted from overextended expectations about the value or effectiveness of a particular treatment.

That doesn’t mean that a particular treatment will not work.  What it does mean is that there is a lot of research that has to be done in the lab and in the clinic before we understand the potential value and risks of novel treatments and approaches to the many diseases known as “cancer.”

Mr. Kanzius’ experiment may well translate into something that is effective in the treatment of cancer.  However, I suspect that the conclusion of the research phase of this endeavor is some time away.

When I gave those interviews a couple of months ago, I actually mentioned some circumstances where I thought the researchers could take advantage of the theory to see if this would work, such as superficial malignant tumors.

I also endorse the comments made on the CBS website, where they write, “That this will eventually cure cancer is still a big if, as there have been many treatments that worked on animals but failed on human patients.”  They go on to say, “It will be at least four years before any human clinical trials will begin for the treatment.”

I hope that those words, as true as they are, won’t be lost somewhere in translation.  I won’t be surprised if desperate people fail to hear them.

Dashing the hopes of patients with a fatal disease is in no one’s best interest.

As part of a policy review today, I discovered that I had posted an incomplete entry to one of my March 13 blogs describing the outcomes of the Onocologic Drug Advisory Committee meeting for the Food and Drug Administration.  These hearings were held for the FDA to get the committee's opinions on a number of issuses related to erythropoiesis stimulating drugs, called ESAs.

Because several I have written several blogs on the topic, I thought it important to correct the original blog with the additional information.  I have pasted the exact copy that I had prepared that day, with no futher edits or changes.  You can follow this link to the blog, which was written on 3/13/08 and titled "And Now, The End of the ESA Story (For Today).  I have clearly indicated which material has been added.

I regret this oversight.

As I write this, I am returning from a trip to Boston where I had the opportunity yesterday to participate in a hearing hosted by the Social Security Administration. 

The topic was “Compassionate Allowance Outreach,” and the issue was how to hasten Social Security disability benefits to patients diagnosed with cancer.

Disability is something that many of us don’t like to think about.  In particular, Social Security disability usually means that you are completely disabled and that the disability is long term, as noted in a Social Security booklet entitled “Disability Benefits.”

The problem for certain cancer patients is that the benefits they have earned and deserve may not show up until it is too late to be of help.

When I started my oncology practice in Baltimore over 30 years ago, I quickly learned as a young physician caring for very sick patients about the problems with Social Security Disability.

The forms were long, the paperwork significant, and the time it took to get a benefit determination seemed interminable for my patients.  Medicare didn’t become effective for two years after a patient was declared disabled, which was long after they needed help paying their medical bills.

The delays—particularly for Medicare—didn’t make sense to me then, and they don’t make sense to me now.

The landscape may be changing, however, since the current Social Security Administration Commissioner—Michael Astrue—has taken a very direct and personal interest in this issue.

The result is a series of hearings nationwide to hear testimony regarding the impact of these delays on those who find themselves disabled.  One of those hearings was held yesterday in Boston.

The Social Security disability booklet points out that if you are a 20 year old worker, you have a 3 out of 10 chance that you will become disabled before you retire.  For Social Security to become effective, you have to have a disability that is expected to last at least one year, or result in death.

There are some specific requirements that must be met to get Social Security disability:

1) You cannot earn more than a minimal amount of money as a result of your illness, which is defined by the Social Security Administration each year.

2) Your medical condition must be severe, which means you have significant limitations on basic work related activities, such as walking, sitting and remembering for at least one year.

3) Your condition is pre-defined as being associated with severe disability, or

4) A state agency must decide if your condition prevents you from being able to do the work you did before.  If you can do that work, then you are not disabled according to the booklet.  If you can’t do your prior occupations, then…

5) Could you do other work?  If you cannot, then you are disabled.

The issue we addressed yesterday was specifically about what can be done to accelerate benefits for patients with cancer, especially those who have poor prognoses or are facing intensive, prolonged treatments.

As noted in our testimony, once someone hears that they have cancer they frequently have their lives completely upended.  What were routine expenses can quickly become insurmountable.   At a time of great need, another burden results from having to deal with the financial impact of a serious and life-threatening illness.

As we told Mr. Astrue and his colleagues, it is the opinion of the American Cancer Society that the delays in getting supplemental Social Security income benefits to patients in need are a serious matter, especially when one considers our concerns regarding to access to care.  We noted many cancer patients face intensive treatment, and have to simultaneously cope with the fact that they are suddenly disabled, watching their income and savings disappear while they desperately do what they can to save their lives.

What you may not know is that there is a five month waiting period to get Social Security disability income (SSDI).  But this is a best case scenario, since the SSA gets millions of disability claims every year, and a backlog is inevitable giving staffing and data limitations (much of the medical information they have to go through, for example, is paper based, not electronic).

Another barrier is that once you are declared disabled, you become eligible for Medicare benefits—but Medicare won’t start until you go through a two year waiting period. 

These delays are far too long for many patients under retirement age who develop cancer.

The solution, however, is not simple.  Many of these requirements have been enacted in the past through Congressional legislation.

As a result, changing the law on waiting periods would require Congress to act. You had better believe that someone is going to raise the question of how we could pay for reducing or eliminating the waiting periods, especially for cancer patients who have extremely poor prognoses.  It would not be an inexpensive proposal, especially given the well known concerns about the lack of financial stability for the Social Security and Medicare programs.

The good news is that Mr. Astrue and his staff are working to do something about this.  That is why these hearings are being held across the country, and why they have put programs in place to reduce the backlogs and improve the initial disability review process.

As we testified yesterday, the American Cancer Society will do what it can to assist in this effort.  The Society is also committed to reducing the two year waiting period for Medicare eligibility for cancer patients in need.

As I mentioned during my comments yesterday, we have to understand the interface where science meets public policy.  It is not always a pretty sight.

Our science is becoming more refined, but our legislative and regulatory policies--in the words of one of the participants yesterday--are “rough cut.” It is not an easy task to bring the two together effectively and in a timely manner.

We did suggest that for certain diagnoses, where the outlook is particularly poor, that the disability process be accelerated and benefits hastened.  We could accomplish this goal through legislative and regulatory efforts, and by using expert panels to determine which diagnoses, stages of disease and treatments could qualify for these accelerated benefits.

I concluded our testimony yesterday with the following comments:

“If we applied a rule of reason, I doubt there are any of us who could object to making certain that hard working people and their families, in their moment of greatest need, should have access to benefits they have worked for, paid for, and deserve. Faced with the diagnosis of a near term fatal illness, frequently anticipating debilitating and expensive medical care, or perhaps requiring end-of-life care, we could at least offer them some comfort in knowing that we cared enough to provide some of the help that they desperately need and deserve.  And spare them the fear of significant debt.”

As the American Cancer Society moves forward with our Access to Care campaign, we cannot forget that there are many facets to the problem. 

Having access to affordable medical care is one of those facets.  Being able to survive financially once you are diagnosed is another.

Speeding up the process to get Social Security disability income and Medicare benefits is not a total solution, but for many in need it certainly would be a welcome step forward.

These are not gifts or handouts.  These are benefits all of us pay for every time we get a paycheck.

Maybe the time is right to address the issue.  After all, thirty years has been a long time to wait.

+++++++

If you are interested, here is the text of our statement:

Commissioner Asture, fellow panel members and guests:

I am honored to speak with you today on behalf of the American Cancer Society, the nation’s largest voluntary non-profit health organization, and our millions of dedicated volunteers in communities across the country.  As you know, the Society is committed to reducing the suffering and burden of cancer, so we applaud your willingness to have this hearing to discuss approaches to streamlining the disability process for those most in need.

We have been fortunate over the past 25 years to substantially reduce the risk of death from cancer through advances in prevention, early detection and treatment.  There are now almost 11 million cancer survivors in the United States and countless lives have been improved by our nation’s efforts to treat this deadly disease.

Despite our progress, unfortunately, there are still many who are diagnosed too late for effective treatment, or who have a form of cancer that is not responsive to many of the treatments we currently have available. For those individuals and their families, the words “you have cancer” carry an even greater burden.

For these people, the burden extends beyond the diagnosis and treatment of their cancer.  There are serious financial concerns for many people faced with a diagnosis of cancer, including access to care, the costs of treatment, and the inevitable financial difficulties associated with daily living, including the loss of employment income.  For many, what may have been routine expenses prior to their diagnoses suddenly and quickly can become almost insurmountable.

The American Cancer Society has made access to health care a top priority.  We recognize that without access, our efforts to promote prevention, early detection and treatment can become meaningless if people can’t afford to get the care they need.  The problem is obviously a serious one for the nation’s 47 million uninsured.  But it is also a problem for millions of people who have health coverage but discover too late that it is inadequate—the cost of full treatment for their cancer is beyond their means because of high deductibles and co-pays, limits on benefits, or the lack of coverage of necessary services.

In 2001, an estimated 2 million Americans experienced bankruptcy caused by illness and medical bills.  Approximately ten percent of these cases were caused by cancer-related costs.  Cancer was the highest cost diagnosis with average out-of-pocket medical costs of $35,878 compared to the next highest cost diagnosis, neurologic diseases, at $15,560.  We know that 25% of cancer patients used up all or most of their savings during the course of their treatments.  One in five of these individuals had health insurance.  For many people, cancer presents an ever-increasing mountain of bills for themselves and their families.

We can only imagine the distress that many patients and their families experience when they discover that there is no safety net to catch them financially once they are diagnosed with cancer.  Facing intensive treatment to save their lives, they may also have to cope with the fact that they are truly disabled and unable to perform their daily work-related activities.  Their jobs disappear, their income and savings disappear, and for many, their short term outlook is dismal.

For some of these individuals and their families, we have the opportunity to address and correct what has become a burdensome and cumbersome system—the Social Security Disability Insurance program (SSDI).  This program, if better structured, could provide a vital level of financial support in a time of great need.

Our purpose here today is to address how we might streamline and improve the process by which Social Security disability benefits are determined and initiated.  We would also like to put on the table for discussion the question of the two year waiting period for Medicare for those who become disabled prior to their 65^th birthday.

Many in this room today are all too familiar with the laws and rules and regulations surrounding Social Security Disability Income and Medicare programs for the disabled.

The five month waiting period for SSDI (which is in reality frequently substantially longer than that because of administrative backlogs) and the two year waiting period for Medicare benefits for those who are disabled are legendary to those of us in the cancer community who see first hand the devastating impact of these requirements.

The American Cancer Society is committed to eliminating the two-year waiting period for cancer patients to obtain Medicare coverage and eliminating other administrative hurdles that prevent timely and essential medical and financial support.  Currently, individuals under age 65 with disabilities, including late stage cancers, can technically obtain Medicare coverage based on their disability.  However, the two-year waiting period makes it extremely difficult for a cancer patient to obtain coverage. The two-year waiting period is particularly detrimental to those individuals with late stage cancer or more deadly cancers like pancreatic cancer where the probability of surviving two years is very low.

Aggravating the coverage delay is the fact that before an individual with late stage cancer can acquire SSDI or Medicare coverage, he or she must first receive a disability determination from the Social Security Administration (SSA), which can take months.  Only then, after the determination from the SSA, does the two year wait to obtain Medicare coverage begin.

As I mentioned previously, the unfortunate reality is that for many patients diagnosed with cancer, their outlook is grim.  The waiting periods are especially onerous for these patients under the age of 65 who present with certain cancer diagnoses and/or advanced disease, those for which the probability of survival is known to be low.  These patients not infrequently go through their diagnoses and treatments without ever having been able to receive a final disability determination.  Even within my own family, there have been circumstances where the time from diagnosis to death was measured in months, too short a period to get either disability coverage or Medicare benefits.

We do believe there are certain criteria which could be applied that would help accelerate the disability determination process and thereby provide a more reasonable approach to getting benefits to beneficiaries in need in a more expeditious manner.

When you review the data from the Surveillance Epidemiology and End Results database of the National Cancer Institute (commonly known as SEER), you can quickly find diagnoses that are associated with particularly onerous prognoses, where a majority or close to a majority of the patients diagnosed with particular cancers have a survival of less than one year. Examples include lung cancer, the most common cause of death from cancer for both men and women in the United States in 2008, where the majority of patients present with advanced disease.  For patients under the age of 65 diagnosed with lung cancer, the one year survival is under 50%, or 46.9%.

For patients with acute myeloid leukemia under the age of 65, the one year survival is 52.7% for men and 59.3% for women.

For patients with localized esophageal cancer, the one year survival ranges from 38.7% for black men to 51.5% for white women.

Pancreatic cancer is particularly deadly.  In 92% of patients, it is a disease that is usually diagnosed beyond the moment when it can be successfully resected.  For all patients under age 64, the one year survival ranges from 21.7% for black men to 32.4% for white women.

I believe the point is clear: there is much more we can do to make certain that, at a time of the greatest need that any of us can imagine, we do not increase the burden of suffering for those with cancer and their families by continuing to impose inordinate approval and waiting periods to get benefits to those who all of us agree need them most.

We propose that Congress and the Social Security Administration work legislatively and through regulation to establish a process which, under certain defined circumstances, would eliminate the waiting periods to receive SSDI and Medicare benefits for patients with certain cancer diagnoses.  These patients would meet redefined and more appropriate disability criteria which reflect their medical need and expected survival.

We could base these criteria on survival probabilities as determined by diagnosis, stage at presentation, and treatments.  The criteria could be established through an expert panel and public comment, and could serve at least as an initial “filter” to be certain that those in most need are moved to the head of the line for disability determination.

If we applied a rule of reason, I doubt there are any of us who could object to making certain that hard working people and their families, in their moment of greatest need, should have access to benefits they have worked for, paid for, and deserve. Faced with the diagnosis of a near term fatal illness, frequently anticipating debilitating and expensive medical care, or perhaps requiring end-of-life care, we could at least offer them some comfort in knowing that we cared enough to provide some of the help that they desperately need and deserve.  And spare them the fear of significant debt.

Again, we appreciate having the opportunity to appear before you today and look forward to answering your questions.  We look forward to working with you, Congress and the Administration to provide whatever help we can to address a need that is so obvious but has been ignored for so long. 

Your willingness to provide a forum and focus for this topic is much appreciated.

Thank you.

It has been a pretty hectic and busy couple of weeks, with travel, meetings, work, and a short vacation.

While I have been otherwise occupied, a lot has been happening.  Unfortunately, much of it hasn’t had to do with advancing the treatment and science of cancer.  Instead, we have learned more than we should need to know about the inner workings of our profession and how research and practice are being supported in the new millenium.

My last comments on this blog had to do with erythropoiesis stimulating agents, or ESAs.  These are the drugs which stimulate the production of red blood cells in patients receiving cancer treatment.  Recent evidence, as outlined on several occasions in this blog, suggests that they may be harmful as well as helpful.

The FDA hearings a couple of weeks ago led to a lot of press, but at the end of the day there may be some more restrictions put onto the use of these drugs.  However, they will continue to be appropriately available for patients who need them while receiving chemotherapy.

The FDA panel did suggest that these drugs not be used in patients who are being treated with curative intent, such as women receiving adjuvant chemotherapy for breast cancer.  The reason for this is that the drugs increase the risk of deep vein thrombophlebitis and pulmonary emboli (blood clots to the lungs), which can be fatal.  The panel concluded that the risk of harm outweighed the benefits for patients where the treatment could lead to cure of the patient’s cancer.

One of the more bizarre moments in the hearing was the occasion where one of the physicians on the FDA panel asked repeatedly whether the drug companies had been giving financial rebates to doctors to prescribe these drugs.

Now, this was not new information.  The topic had been previously reported in the New York Times back in May.

Despite that public knowledge, including verification of one modestly sized practice having received a couple of millions of dollars as part of these rebate programs, the pharmaceutical representative did everything he could not to answer the question.

Instead, there were long winded and obviously pre-planned responses which were designed to deflect an answer.  Comments such as there is no evidence that these rebates influenced practice, and so on.

The doctor had to reask the same question several times before getting a simple, “Yes.”

It was very demoralizing to watch this in person and realize that if you need to work so hard to hide something then you must realize that it doesn’t look particularly good in the light of day.  If that’s the case, then why do it at all, especially when Medicare beneficiaries are forking over their money (and the government is forking over our money) to pay for these so-called rebates?   Why not just reduce the price of the drug so everyone can benefit?

The behavior I saw at that hearing makes me wonder whether more “rebate” programs are out there, and how much is being paid to doctors to prescribe these expensive drugs.  I hope the answer is “none” and “zero,” but after what I saw at those hearings I am no longer so certain.

And, from my perspective, it was difficult to watch the hearing avoid the entire question of the off-label use of these drugs in treating the anemia of cancer patients not receiving active treatment.  Since that is not an approved use, the FDA has no jurisdiction over their use and could not address that question as part of this hearing.

Yet, who knows how many patients are receiving these drugs at what cost in a circumstance where there is no scientific evidence of benefit and where there may be substantial risk? 

I guess silence is supposed to be preferable to sunlight, but that is difficult for me to accept.

The other distracting event of the past couple of weeks was the publication of a front page story in the New York Times on March 26 which revealed that the physician who has been the leader of research into the effectiveness of CT scanning for the early detection of lung cancer in fact headed a foundation that had received $3.6 million from one of the tobacco companies from 2000 to 2003.

That money, in turn, has helped fund a major international lung cancer screening trial that, in the opinion of the investigators, demonstrated remarkable survival in patients who had their lung cancers detected by CT scans.

As noted in the Times’ article, the American Cancer Society has also made grants in excess of $100,000 to the same study, some to support part of the research program and part to support the meetings held regularly by the investigators to update the results of the research.  We did not know that tobacco money was involved in this project.

This same researcher was recently called to task because she and her colleagues have patents that are related to her research program, yet she had failed to disclose that information on the articles she had authored which appeared in leading medical journals and in lectures she has given in multiple venues.

Now the hordes are swarming, claiming that the research she has performed may be tainted.  Although I personally hope that is not the case, it has raised a cloud over what up until now has been a vigorous discussion among experts about the effectiveness of lung cancer screening.

The conflict was uncovered because a footnote appeared in a study that was published in the New England Journal in October 2006.  An enterprising reporter followed up on the notation that the research project had been supported by Foundation for Lung Cancer: Early Detection, Prevention and Treatment.  That’s when they found out about the tobacco connection.

In our world, any connection to tobacco money is as taboo as it gets.

This particular story and its fallout continue to unfold as I write this, as witness the editorial just posted by the editor of the New England Journal.

I guess you might say that I am a bit despondent that we are now spending more of our time dealing with peripheral issues than promoting a common agenda against cancer, either through improving access to care or advancing cancer research and treatment.

Conflicts are all around us.  Even I have become more aware of my own conflicts, and realize that I need to pay more attention to how my various activities may in fact raise conflicts with one another.

But I am concerned that many otherwise well meaning and well intentioned researchers and scientists don’t perceive their activities as creating conflicts, and that we are dealing with may be the tip of the iceberg.

Taking large amounts of money from tobacco companies then doing research on lung cancer is a conflict.  Taking large amounts of money from drug companies then touting their drugs is a conflict. 

I could go on and on about these types of situations.  They are ubiquitous, and are far more serious that taking a doctor taking a  pen from a drug company at a medical meeting.  My friends, the conflicts that I am talking about are insidious, ubiquitous and becoming an integral part of our professional and research landscape.

I certainly don’t have an answer as to how we get ourselves back on track.  Exposes such as those in the New York Times and the Cancer Letter are unavoidable if we behave the way we do.

What will it take for us to regain the high ground? 

It is infinitely better for us to straighten our own house as opposed to have others do it for us.   But if we don’t get busy, we will have only ourselves to blame.