Dr. Len's Cancer Blog

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Dr. Len's Cancer Blog

The American Cancer Society

Thank You, Mr. President!

by Dr. Len June 25, 2009

Last night was a special moment for me: I was one of those 164 people representing the “face of America” that was in the East Room of the White House as Charlie Gibson and Dianne Sawyer from ABC News interviewed the President as he answered questions about health care reform.

 

My bottom line conclusion?  This guy knows his stuff.

 

You may have already seen the telecast or snippets on the morning shows (if you can get past the lead story about the Governor from South Carolina).  If so, there isn’t much I can add to what you have already heard.  But what I can say is that—aside from the glamour and imposing “presence” of the room itself—I was overwhelmingly impressed with the President’s grasp of the issues and his ability to respond effectively if not always completely to the questions he was asked.

 

I have been through this before.  I have been “in the room” when political figures address audiences and promote their policies.  And, like you, I watch television from time to time, see the debates, listen to the Sunday morning talk shows, and draw conclusions as to whether I agree or disagree or whether I like or don’t like (or don’t really care) about the person who is the target of an interviewer’s probes.

 

I have over the years become somewhat blasé and perhaps a bit cynical about “the show”.  The answers are frequently scripted and perfunctory, repeating the same sound bites again and again.  They are—in a word—predictable.

 

One could make the argument that the President’s responses last night had some of that same predictability.  But although the interviewers and the questioners had their scripts in hand (it appeared that the people who appeared on camera had been selected after having submitted the questions in advance, since the hosts knew who they were looking for and those people were positioned in certain accessible parts of the room), I don’t believe the President knew what was coming.

 

That’s why I believe his presentation was in fact what I would call a “tour d’ force” on health care reform.  You may not agree with him (I won’t tell you here which parts I thought were right on target and which ones gave me pause), but you can’t fault him for not knowing his topic. 

 

This man sat there for 90 minutes and took on every question he was asked.  And although some of us in discussions after the show recognized where he did a little bobbing and weaving, almost to a person we thought he was masterful in his ability to articulate his position.  And those comments came from some of the most knowledgeable Washington health care “players” that I know.

 

That, my friends, is what I would call “high praise.”

 

It is clear that this President means what he says about advancing health care reform.  Looking at him up close and personal—and I was close if not personal—I can tell you he didn’t flinch, didn’t recoil, and didn’t react adversely to any question (although I did think his answer about basing health care policy decisions on a person’s “spirit” to live put him in a tough spot).

 

So, if I had the opportunity, what questions would I have asked?

 

First and foremost, I would have thanked him on behalf of the Society and the millions of people and their families who are confronting cancer today for making the issue of accessible, affordable, quality health care a priority of this administration, this Congress and this nation.

 

I would have asked how his proposal would have helped the Americans who spend themselves into poverty treating cancer and other chronic diseases. 

 

Our advocacy affiliate, the American Cancer Society Cancer Action Network recently completed a survey that showed 20% of American families spend most or all of their life savings when faced with paying for cancer treatment, and one out of seven families accumulate thousands of dollars of uncompensated debts as a result of a cancer diagnosis. 

 

The diagnosis of cancer not infrequently—and unfortunately—brings with it huge personal financial burdens and all too often outright bankruptcy.  We can’t have people going through their life savings while fighting for their lives.  It’s almost like being in a fight with one hand tied behind your back, although in the case of cancer the consequences are much more serious.

 

I would have asked how we can make certain that everyone has access to preventive services, so we can find cancer early when it is most treatable and offers the best prognosis.  Too many people have to put off or never get recommended screenings for cancer because they simply can’t afford them or don’t have health insurance that covers them.

 

My next question would have been about the portability of insurance coverage, and how to maintain affordable, effective health insurance even if you are too sick to work. 

 

The platitudes about COBRA and how it protects us makes me want to…. (fill in the blank, because I can’t write the words I would like to say here).  I have been out of work in the past, and even 10 years ago the cost of maintaining health insurance for my family was over $12,000.  Without an income and not much savings, that was a very, very large number.  A member of my family recently graduated from college, and the cost to insure her was enormous.  She is now among those 46 or 47 million uninsured they talked about last night.

 

Being sick with cancer and losing your job is bad enough.  Paying through the nose for health insurance after you lose your job makes it worse.  Talking dispassionately about how people can maintain their coverage in those circumstances as though this was a simple mechanism at a reasonable cost just doesn’t cut it with me.  I guess you could say that this particular issue is personal.

 

The final question would have been what protections will be put into place to be certain that people have health insurance that is adequate to meet their needs if they have to be treated for cancer.

 

Too many folks find out too late that their health insurance has a variety of limitations and maximums that simply don’t cut it in today’s expensive treatment environment.  When you have drugs that cost over $100,000 a year each, and scans that cost over $3000 each, you find out that what you thought was a lot of coverage can disappear very, very quickly.  We need to provide assurance to the American people that they have adequate coverage for the prevention, diagnosis and treatment of cancer, from the very first step to the very end of life.  No one—and I mean no one—wants to have cancer.  And no one should be left unable to afford effective, quality based, adequate treatment for their disease.

 

So those were the questions I would have asked the President, and you can decide for yourself whether or not he answered those questions in response to the ones he was asked last night.  And if you didn’t hear the answers, maybe you can ask those same questions yourself and decide whether or not the various plans you are hearing about every day meet the tests outlined above.

 

Let’s finish here on a perhaps more humorous note, which is the “other comment” that I was prepared to make.

 

If you know me, you are aware that I look somewhat like Phil Jackson, the coach of the Los Angeles Lakers who recently won the NBA championship. Knowing that the President is a basketball fan, I was prepared to respond if he made the comment I have heard many times before, namely “Do you know you look like Phil Jackson?”

 

My response to the President would have been, “Sorry, Mr. President, but I’m not Phil.  However, my colleagues at the American Cancer Society, our advocacy affiliate the American Cancer Society Cancer Action Network, and our millions of volunteers across the country would like to bring home a more important championship, which is accessible, affordable, and adequate health care reform for everyone in this country.”

 

That is something all of us could celebrate.

 

Mr. President, thanks for inviting me to your “House.”

Filed Under:

Cancer Care | Medicare | Treatment

Workers Also Count In Reforming Personal Health

by Dr. Len June 24, 2009

I have been in Washington the past several days primarily to participate in a congressional staff briefing on the importance of funding for research and to attend the discussion with the President on ABC’s “Prescription for America” which will air this evening at 10PM EDT. 

 

But something I saw yesterday really bothered me, and brought me back to reality when it comes to understanding the barriers our country faces in achieving true personal health reform. 

 

The issue?  The extent of overweight and obesity in this country and its impact on our health and our health care costs.

 

The moment occurred in my hotel, which was hosting a meeting of a well-known nationwide union.  I don’t know the topic of the meeting, but there were a lot of folks in the hotel, all wearing their shirts with the same logo and message.

 

When I looked over the crowd I saw something that shook me to my physician core.  These were working people—I suspect many of them hard working people—but the number of them who were overweight and obese was astonishing.  The personal impact of the sight surprised me.  It was unmistakable that this group of folks was—from a medical view—in serious trouble, if not already there.

 

When I recovered, and tried to understand why I reacted the way I did, I got to thinking about the implications of the observation. 

 

Here I was just the other day writing a blog about the success of employers in improving the health of their workers.  What I hadn’t given much thought to was what the “other side” of that equation (the unions) was doing to help their members—their lifeblood and their future—address the same issues involved in creating a culture of health.

 

This is not a commentary that is pro-union or anti-union.  This is about the millions of people in this country who go to work every day to get the job done. It is a commentary that is pro-health and pro-people.  It is a commentary that all of us are in this together.  If we don’t fix this problem as a nation, whether you are an employer or an employee, we are going to be in a heap of trouble.

 

Health care costs affect unions just like they do employers.  This is, in a sense, a one-size-fits all type of issue.  More money on health care means less money for wages and other benefits.  And, for unions that run their own health insurance plans, it impacts the fiscal health of their organization just the same way health care costs impact the bottom line of a large corporation.

 

 

I spend a good deal of time traveling around the country, and in particular from my office in Atlanta to my home in southwest Georgia.  I frequently stop at truck stops for the obvious reasons, and as a result get to see a lot of truckers and other travelers.  These men and women do work hard, and they work crazy hours.  And many of them are—you guessed it—overweight and obese.  How do you reach out to them and get them to make healthier choices?

 

They certainly aren’t going to get there with a giant burger and a super-large helping of French fries.  (You can only imagine how exciting it is to see a truck stop that actually offers healthy choices—and see the truckers who do take the message to heart.  But as I have said previously, I lead a strange life when it takes things like that to make me feel good.)

 

These are just small examples of a much larger issue: how are we going to change our living environment to make healthier choices the norm, get more exercise, get down to a healthier weight, and avoid the metabolic catastrophe that is engulfing you, and me and everyone we know?

 

I don’t have a simple answer to this problem, and heaven knows I have my own daily struggle with trying to eat right, exercise and get rid of the extra pounds I have carried around most of my life.  And if I am having trouble staying the course, then how the heck are others going to be able to do this if they don’t live and breathe this message???

 

So to those of you out there who are everyday folks putting in your best effort to make ends meet, maybe you have some suggestions on how to answer the challenges to our health that we all face.  It would be great to hear from you, and have you share your thoughts and your experiences.

 

And maybe the unions will stand up (maybe they already have, although I don’t have any examples at hand) and work with their members beyond the basic issues of pay, work rules and health insurance, and make overall health an important goal as well.

 

I like people.  I believe the best in people.  I believe that most of us have the power within us to change. All of us should be able to do well and prosper medically, spiritually, and financially.

 

I have no doubt that those folks in the hotel were good people who believe in their cause.  I just wish they had a little extra left over to commit to a greater cause, which is to regain our health along with our optimism.

 

To me, that would be a something that all of us should negotiate for.

Filed Under:

Diet | Exercise | Prevention

Workplace Solutions: Creating A Culture of Health

by Dr. Len June 23, 2009

I had the opportunity last week to participate in a conference sponsored by the American Cancer Society and others that brought together companies to talk about changing the course of cancer through innovative corporate programs and policies.

 

The take home message for me was that if we are going to solve the health care crisis in this country, we are going to have to learn about the unique and successful corporate health focused initiatives that are happening all around us.

 

I have given a lot of thought to our health care system (or should I say non-system) over the years. I came to the conclusion years ago that there are always better ways to do things if only we were able to sift the wheat from the chaff, and move the best ideas forward. There are examples out there, but all too frequently they don’t get much notice.

 

This conference pointed out that corporate America has not been standing still when it comes to trying to find solutions to improving the health of our country while holding down the incessant spiral of health care costs.

 

There were numerous examples of program successes presented at the meeting. 

 

A representative from Safeway highlighted their company’s efforts to rein in health care expenses while improving the health of their employees.  That plan has received a lot of attention recently, including a prominent article in a recent Wall Street Journal. They have incorporated financial incentives into a workplace solution that helps people meet their goals for their own health and has resulted in significant improvements in several measures of health, such as a decline in smoking rates. They have held health care expenses in line, while improving the health of their employees.

 

Another company that has taken the proverbial “bull by the horns” is Caterpillar, where they have instituted a “pay for quality” initiative for colorectal cancer screening in their major manufacturing location of Peoria, Illinois.  They negotiated rates for colonoscopy with the local gastroenterologists and hospitals, and worked with them to develop quality measures for colorectal cancer screening.  The program has been successful at reducing costs and improving quality, a goal that many seek nationwide. 

 

The reality is that in Peoria, Caterpillar has enough employees who need colonoscopy to make a “market solution” work.  The same would probably not be true elsewhere for many other companies when it comes to negotiating a fixed fee for the procedure, but the bottom line for me is that when it comes to quality medical care there is no reason their same “quality indicator” process for colonosocopy should not be in place voluntarily nationwide.

 

Then there was what I would call the “stunner moment” when the medical director from Caterpillar mentioned that the food service for the company has been placed under the direction of the medical department, not a more traditional food service organization.  Now, that may not get you very excited—and may make you wonder what kind of a life I lead—but in my book that is a real innovation. 

 

The end result is the availability of healthier food choices, and a tiered cost structure both in the cafeteria and the vending machines that moves people to make those healthier choices.  And, I understand the economics have worked out as well.

 

There were a number of other presentations, but I think you get the point.  Solving the health care crisis is not going to be done in one sweeping motion.  We need to be innovative, creative, and supportive.  We need to put our minds together and figure out ways to do this better. 

 

Our large companies may in fact have some of the answers.  Where paying health insurance premiums was their prime interest a number of years ago, they are now realizing that they have to pay creative attention to health care and lifestyle solutions since many of them are footing rapidly escalating costs in providing insurance for their workers.

 

Simply paying the insurance premiums no longer works, according to some of the people I spoke with at the conference.  However, to be fair, there are others who noted that their corporate managements are still not fully on board.  Getting traction with health care initiatives within a company bureaucracy can be a daunting task, especially when the effort is not tied directly to the core mission of the company and adding dollars to the bottom line.

 

Someone pointed out during the meeting that when you think about it, many of us spend 40 hours or more at our work every week.  In a 168 hour week, when we are supposed to spend 8 hours a night sleeping, that means a good portion of our waking hours are spent somewhere other than in our homes with our families.

 

That means that there is enormous potential for our workplaces to be our “health places” and influence our health behavior.  Not that health is the primary focus of a company.  It’s their product or their service that is obviously paramount to their mission.  But it is by creating a “culture of health” and helping to subtly direct our healthy choices and our healthy behaviors that our companies can really make a difference.  And, as noted by several participants, when senior management sends a healthy message and participates in healthy behaviors it has a huge impact on the workforce.

 

Think about it for a moment: how many meetings do you go to where your company serves lunch or a snack?  How many times do they make healthy choices available, or even feature a healthy choice?  How many times do you see the cookies and the chips as opposed to the apples and the popcorn?

 

Even I had to take a second look at the bag of “healthy chips” served as a snack at one of our American Cancer Society meetings the other day.  A quick calculation told me that innocent bag of “healthy chips” had close to 300 calories.  I opted for the smaller bag of pretzels which checked in closer to 100.  It’s those small choices that add up to big differences over time.

 

Temptation is all around us.  If we thought about it, we should be working to make certain that healthy choices should be all around us instead.  It wouldn’t take much of an effort for our pre-meeting breakfasts to have low or non-fat milk, non-sugared cereals and low fat/low calorie yogurt instead of bacon eggs and potatoes.

 

So here is a “tip of the hat” to those companies that are trying to do something to improve the health of their employees, and maybe giving us some clues as to how we can improve the health of America as well.  Your efforts are not going unnoticed. 

 

We are one of the greatest innovative societies ever known, and our companies are very much a part of that culture.  Putting their corporate minds to work improving our health is not such a far-fetched idea when you think about it.

 

Sharing those ideas, as we did last week in Chicago, is simply a first step. That’s what we need to do on a larger scale if we are going to make progress in moving from a culture of illness in this country to a true culture of health. 

 

Innovations like these are a vital part of moving us down the path to getting our arms around the problems we face today if we are to develop the solutions we need for tomorrow.

Filed Under:

Cancer Care | Diet | Prevention

CT Colonography and Medicare: Are We The Enemy?

by Dr. Len June 17, 2009

A recent article in the New England Journal of Medicine praising the decision by the Centers for Medicare and Medicaid Services to not cover CT colonography for the prevention and early detection of colon cancer for Medicare patients left me with a great deal of concern—especially since it was written by some of the same people who made the decision in the first place.

 

I consider myself a fairly reasonable, experienced and tolerant person when it comes to the legislative and regulatory decision-making processes.  You win some, you lose some, you reevaluate and generally you move on to the next issue.  But this time, for me at least, it’s different.

 

The article, which was published online on May 27, 2009 in the New England Journal of Medicine, reviewed the basis for the decision denying coverage for CT colonography in the Medicare program, an issue I have covered previously in this blog.

 

Here are the opening paragraphs from that article.  Remember, these are the words of the authors, some of whom had either participated in or wrote the final CMS regulation denying coverage for the test:

 

“In an unprecedented endorsement of evidence-based medicine, the Centers for Medicare and Medicaid Services (CMS) recently decided to deny coverage of computed tomographic (CT) colonography for cancer screening, concluding that ‘the evidence is inadequate.’ The CMS emphasized that the ‘pivotal, overarching concern’ in its decision was the fact that the findings of trials showing a benefit of screening with this method were not necessarily generalizable from the study populations to other groups of patients. In particular, the CMS noted that the mean age of participants in the studies that were cited in support of coverage was significantly lower than that of Medicare beneficiaries. There were no studies evaluating this technology in the elderly, nor were there analyses of subgroups of participants over 65 years of age.

 

“Does the CMS’s strict application of evidence-based analysis herald a shift in its approach to national coverage decisions? We hope so.”

 

My friends, these comments have serious implications.  These are not the words of some outside experts or editorialists who are offering an opinion about how Medicare should make coverage decisions.  These are words of the decision makers themselves.  

 

The key words here are “evidence based analysis.”  Just remember that one person’s conclusion about the results of such “evidence based analysis” may not be the same as someone else’s.  Tweak the data inputs on the models and your evidence-based analysis may go right out the window if you don’t have accurate, up-to-date information.  An analysis is only so good as the quality, validity, and “timeliness” of the data you have to analyze.  Sometimes you have to acknowledge that the data in your model may not be good enough.

 

In the case of CT colonography, I would argue (as I have previously) that the data used in this analysis was, shall we say, a bit dated.  In included studies that looked at old technology, did not consider the new huge costs of treating advanced colorectal cancer with targeted therapies, and didn’t address the question of what happens if more people end up getting effectively screened for colorectal cancer and prevent the disease, as opposed to simplistically concluding that CT colonography vs. traditional colonoscopy is an “either/or” decision.  And, it ignored the fact that you can’t compute the cost of the test if you have not yet determined what the payment will be for that test in the Medicare fee schedule.

 

The authors go on to say that the quality of evidence for many of the treatments we use for Medicare patients is weak.  That is a very true statement, and an unfortunate reality.

 

In fact, I would maintain that if we applied strict evidence criteria to the diagnosis and treatment of Medicare patients today—as suggested by this article—then we could solve the shortfall in the Medicare program tomorrow, because virtually no drug, no test or any procedure would survive this rigorous “evidence based analysis” that was applied to CT colonography.

 

I assure you I am no wild-haired doctor who thinks that the government should pay for anything I want to do for my patients, regardless of cost or other consideration.  It is no secret that I believe we must carefully evaluate what we do for our patients, and that we must move to a paradigm where we provide the right care to the right patient in the right place at the right time.  Simply stated, in the United States we spend way too much money on medical care and don’t get sufficient benefit in return.  I firmly believe that we need to address the overuse of tests and procedures of little or marginal value, if we are going to “bend the curve” of rising Medicare and medical expenditures.

 

But when it comes to saving lives, I think we need to be a bit more careful about the conclusions we draw from the evidence that we have as well as the evidence we don’t have. 

 

When there are significant and substantive disagreements about the evidence and the impact of a particular screening test or treatment that is used in the Medicare population, we need to develop approaches that are designed to resolve those ambiguities before concluding that the test doesn’t work.  We must seek the answers to the questions we must ask.  We can do that through the Medicare program, through the judicious use of a process called “coverage with evidence” or CED.

 

The American Cancer Society and the medical professional organizations that approached CMS about coverage for CT colonography recommended such a CED process be used in this circumstance.  The professional societies agreed to put a rigorous process in place to answer the very questions that CMS was asking.  That wouldn’t result in wide and unfettered use of the test.  Rather, it would continue evaluation of the test while allowing the opportunity to get screened with the test to move forward under very controlled conditions.  They have already done that with other radiology tests, specifically PET scans.

 

CMS denied that request, although they didn’t mention that in their “evidence based” article.  They claimed to us that they couldn’t use CED under their regulatory procedures since—unlike PET scans which are used in to treat of cancer, and which is there is substantially less well done evidence-based research—CT colonography is used to prevent cancer.

 

Other very knowledgeable experts disagreed on their interpretation of the law and their regulations, but the CMS folks were—in my personal opinion—too anxious to “just say no” and prove their point that they could stand up to the “special interests” that were pressuring them to do otherwise.  Their “article” in the NEJM—which appeared surprisingly quickly in a journal that is known for very long lead times for publication of scientific articles--suggests that there may indeed be some foundation to my opinion.

 

Here is another quote from the article:

 

“These findings suggest that many previously approved interventions may lack evidence of benefit in the Medicare population — the group for which U.S. taxpayers are footing the bill. We believe that the CMS’s decision in the CT colonography case, therefore, is a long-overdue step toward meaningful validation of clinical-trial evidence in Medicare beneficiaries.”

 

But here is what I would call the “zinger” paragraph, the one that gave me pause and the greatest concern.  Remember, these authors are in part the “judges” of the decision.  Some of them are or were employees of the agency at the time the decision was under consideration, and had influence on that decision:

 

“Our optimism, however, is cautious. Powerful pressure will inevitably

be applied to the CMS. Indeed, after the agency published its draft decision in February, proponents of CT colonography, in a now-familiar pattern, quickly mobilized. More than 350 comments were submitted to the CMS by interest groups, many with a financial stake in use of the technology. Radiologist groups

and manufacturers of CT equipment, among others, launched a write-in campaign, conducted congressional briefings, and persuaded 56 members of the U.S. House of Representatives to sign letters urging the CMS to reconsider.

Advocates for the medical device industry asserted that the agency lacked the authority to consider data on cost-effectiveness in its decisions. Already at least

one representative, Kay Granger (R-TX), has issued a press release expressing the hope that the CMS will reconsider its decision.”

 

Maybe this is the place where I should be grateful that the authors didn’t offer full discussion of the events that went on prior to the final decision, but here is the fact:  One of those groups who participated “in a now-familiar pattern” was the American Cancer Society.  We submitted comments, we participated in public and private meetings with CMS, and we participated in a congressional briefing where I personally presented a discussion about colon cancer and the potential value of cancer prevention and early detection, which in our opinion includes CT colonography.  But maybe mentioning the American Cancer Society would suggest that not everyone who promoted coverage of this test had a direct financial interest in the outcome.  Maybe we aren’t viewed to be as villainous as the others the regulators singled out in their article.  Whatever the reason, we were there because we have come to the conclusion that this test would save lives from a preventable disease.

 

(By the way, to my knowledge, we have made no direct contact with any legislator about this issue, nor participated in any group which asked Congress to approach CMS on this issue.)

 

After all, we had published a guideline in March 2008 and came to the conclusion that CT colonography was a useful test—in fact, a preferred test—to prevent and detect colorectal cancer. We did so independently.  We don’t make CT scanners, we are not a medical device manufacturer, we have no patents on the technology, and we don’t earn our living from doing the test.  We just represent the ordinary person out there who may want to avoid a fatal disease.

 

One more thing: you should not be singled out as a scoundrel for pleading your case to federal regulators. 

 

Last time I checked, this is a democracy.  You are allowed to let your elected representatives know your position, and you are allowed to submit your comments to regulators about pending regulation and even to speak to them about your concerns.  It is not illegal, unethical, inappropriate, inconsiderate or anything else.  It is part of the way we make decisions in this country.

 

Here’s more from the article:

 

“Indeed, it is worth asking why the CMS has acted differently this time. Perhaps the agency is responding to the current economic reality: with the Medicare hospital insurance trust fund projected to become insolvent by 2017, the CMS no doubt recognizes the need to ensure that we are spending Medicare dollars, first and foremost, on improving the lives of Medicare beneficiaries. With Medicare expenditures increasing at an unsustainable pace, the CMS appropriately —

indeed, necessarily — considered whether the procedure is effective in its beneficiaries.”

 

I don’t want to sound cynical here, but last time I checked Medicare was supposed to provide coverage for reasonable and necessary medical care.  The fiscal issues are nothing to sneeze at.  They are very real, very legitimate and for many of us immediate concerns.  But that is a legislative issue.  The key words for Medicare are “reasonable and necessary.” 

 

I would propose that we need to move forward with CT colonography under a CED process, and answer the legitimate disputed question about cost effectiveness.  The American Cancer Society obviously believes the test is “reasonable and necessary” and in fact considered it “preferred” as a means of finding colorectal polyps before cancer develops and invasive cancers at an early stage.

 

There is no question but that the costs of medical care are a real and pressing concern.  We are in the midst of an intense debate about the financing of health care in this country.  Part of that debate includes a discussion at the political/legislative level about what treatments and medical services we will pay for going forward, and how we will make those decisions.  That is part of the public debate, as it should be.  But now we have the regulators stepping out in front of everyone else in claiming they will solve the problem, even if the premises on which they base their decision may be subject to criticism.

 

What is the problem with their premises?  The technology on which many of the effectiveness studies have been done was old technology.  Assumptions regarding the use of the test may be flawed.  The cost data was from a past era in the treatment of colorectal cancer.

 

Even the President acknowledged in his speech to the American Medical Association the other day that one of the measures that will save us billions of dollars in health care costs over the next decade will be making biologic therapies—read that “targeted therapies” in cancer care—available as generics as soon as possible.

 

What you may not know is that the costs of biologics is rising and rising quickly in the Medicare program.  And these drugs are used to treat advanced colorectal cancer.  And the “cost effective analysis” done by Medicare gave the costs of those drugs no consideration, since it was based on data from earlier in this decade before biologics were even available to treat this disease.

 

So, the President knows this issue.  His regulators obviously do not.  Prevent a colon cancer and you may just save the system a whole lot of money, not to mention someone’s life.

 

As to CMS’ cost effectiveness analysis itself, I heard another presentation at the recent meeting of the American Society of Clinical Oncology that disputed the CMS’ “definitive” conclusion.  Although the presenter acknowledged the issue, he concluded that the data on the newer CT colonography technology is simply insufficient to draw meaningful, firm conclusions.  And, my friends, he is not a gastroenterologist, a radiologist or a medical device manufacturer.   He is a highly respected chairman of a department of internal medicine at a major medical center.

 

Here is the concluding paragraph from the article:

 

“We applaud this landmark decision, and we hope that the agency remains firm

in its evidence-based approach and extends its application as health care reform proceeds.”

 

Given the fact that two of the authors on this article were directly involved in the CMS decision, it sounds more like a pat on the back than applause from the audience.

 

My bottom line concern?  We need to fix this system and this process, but we need to do so in a way that is realistic and not absolutist. 

 

Those of us who tried to work with CMS to get this done the right way (and offered concrete suggestions on how to do that) ended up being vilified in the pages of the world’s leading medical journal.  That is not a comfortable place to be.

 

If this is the attitude that we are going to have to deal with as we move forward in tackling these difficult issues, then that portends real difficulties as all of us try to work together to solve the very real problems we face when it comes to improving the quality and costs of our health care delivery system.

 

Simply stated, there has to be a better way.  Publicly questioning and criticizing the motives of others in the pages of the New England Journal of Medicine is not going to get us where we need to be.

Filed Under:

Colon Cancer | Medicare | Screening

For The President, Cancer Is Personal

by Dr. Len June 15, 2009

Ok, Ok. I must admit that sitting about 40 or 50 feet from President Obama as he delivered his talk this morning at the annual meeting of the American Medical Association House of Delegates was pretty special (I even have the pictures to prove it).

 

The talk, surprisingly, included a number of comments about cancer and the importance of health care reform as it related to the treatment of cancer and the impact of cancer on the lives of ordinary people.  The difference here, perhaps, is that this President knew and loved one of those “ordinary people.” That person was his mother.  He used the opportunity of this address to once again remind us of his family’s personal travail trying to pay for her medical care and the impact that had on their lives at a very difficult time.

 

I must admit that when I heard that the President was coming to Chicago to address the AMA House of Delegates I was a bit surprised.  After all, the House is filled with physicians who are very committed to the care of their patients, but are also very politically savvy.  They are for the most part doctors in private practice, and it is no secret they are generally conservative in their political views and don’t welcome government involvement in medical care payment and decision-making.

 

So I give the President a great deal of credit for his willingness to face this audience.  Not surprisingly, he was masterful. He articulated his positions clearly and effectively even if some of them were not warmly received. To me, that is not a sign of confrontation but a sign of strength.  It gives the parties an opportunity to clearly understand the limits of the discussions and where negotiations are possible.  In other words, you may not like what you hear but you know where you stand.

 

However, that is not what this blog is about.  This blog is about where we are headed with health care reform, how that is going to impact the care we physicians offer our patients, the care our patients receive—especially our patients with cancer.  This discussion is all about access to quality, affordable health care and how we get there.

 

The President’s comments contained many of the positions that have been articulated elsewhere.  I don’t follow the President’s speeches closely, but I have read and heard some of these sound bites previously.

 

The basic themes?

 

·        The status quo is unacceptable. 

·        We need to make investments in health information technology and create effective standards to transfer information from one place to another electronically. 

·        We need to adjust our Medicare payment system and make it more stable. 

·        We need to address medical liability issues and costs. 

·        Controlling spiraling health care costs is one essential step to the road to prosperity for our country.

 

The President also made reference to the same basic observation that I make regularly in my lectures and writings:  we spend far more money for health care per person in this country than other developed countries, and we have a life expectancy that is near the bottom of the list for developed economies.  We are not getting value for the money we are spending on health, and it is going to bankrupt us as a nation if we do not “bend the curve” of constantly increasing spending for health care. 

 

Then there were the references to the burdens placed on patients and their families by our current health care payment system.  He noted that we are “paying more, getting less, and going broke.  The status quo is unsustainable.”  Health care is not a luxury, but a necessity.  The costs of fixing the system are considerable, but the cost of inaction is greater.  If we don’t act, health care costs will consume 20-30% of our gross domestic product in the foreseeable future.

 

For a long time, I have been an advocate for preventive care.  I have also been an advocate for improving the quality of care we provide our patients.  Clearly these are items on the President’s agenda.

 

He highlighted the passage recently of the bill which will move control of tobacco to the jurisdiction of the Food and Drug Administration. The President wants to invest more in preventive care, which he emphasized starts with individual responsibility, including not smoking or stopping smoking, getting screened for diseases including cancer where early detection and prevention is known to work, decreasing junk foods, and getting kids more active including playing outside once again instead of sitting in a room watching TV.  He even highlighted the vegetable garden he and his wife planted at the White House (although he gave most of the credit to his wife).

 

There was obviously a lot of discussion in the speech about his suggestions about how to reform health care, but those are more political and currently in flux so I am not going to discuss them here.  He did get the attention of the doctors when he said he wanted to reverse the trend of taking medicine from a profession to a business.  “That’s not what made you a doctor.  You entered this profession to be a healer.”

 

When he talked about specific measures to reduce the costs of medical care, one of the items that caught my attention was his recommendation to speed up availability of generic biologic therapies—such as targeted cancer therapies—quickly.  That, he said, would save billions of dollars over the next ten years..

 

And then the conclusion: “I don’t want your children and their children to be talking about a health care crisis 50 years from now.”

 

The reference to his mom was poignant and personal.  As the President noted, he has talked about this before, and he has obviously included cancer patients in his past discussions and his presentations.  His goal? To change the system so others don’t have to experience what his family experienced in their time of need.

 

That led me to thinking about the story a good friend of mine told me a couple of months ago.  His mother had melanoma, diagnosed at a late stage, and her days were short.  His father had worked three jobs a week, for years, yet couldn’t afford his wife’s medical care.  Not a slouch, not uninsured, just a hard working man with a dying wife.  My friend recounted with anger that his mother could deal with her fate, but got very upset day after day as she was dying when another bill arrived and she didn’t know how it was going to be paid.  After her death, his father was advised by an attorney to file bankruptcy—one of the many who have done so every year as a result of health care costs.

 

And then there was the young couple I met while I was here in the meeting in Chicago. They are both working professionals in their field.  After I talked with the wife, I found out her husband had cancer.  He is young, in his 30’s and the cancer is advanced.  Yet he keeps on working, and is going to receive treatment on a clinical trial.  They certainly didn’t expect this, and there was no family history of colon cancer.  The husband told me he had insurance, and the bills could be handled so far.  But imagine what it must be like to be a young couple, diagnosed with advanced cancer, and need intensive treatment to at least delay the disease. 

 

No one, my friends, plans for that personally, psychologically, or financially.

 

So the problems are all around us.  And I suspect the solutions are also all around us.

 

The President came to Chicago to state his case, and asked for collaboration and engagement going forward.  He received a more enthusiastic reception than I would have expected.

 

It is the personal stories that bring the message home.   We can talk theoretically about rebuilding information technology, redesigning payment systems, whether or not a public plan is going to be part of the solution and if so how that plan is going to be designed.

 

However, my friends, at the end of the day, it’s all about the people.  The people we know, the people we love and the people we care for.

 

The President knows that up close and personal.  My friend knows that up close and personal, and that young couple I met by sheer coincidence knows that up close and personal.  In fact, most of us know that up close and personal.

 

Moving forward, we know that there are times we are going to have to agree to disagree if we are going to get health care reform done.  The President reached out to the doctors here in Chicago, honestly and openly.  And for once, a politician came into this House of Delegates and told the story reasonably straight, even the difficult parts.

 

However, ultimately, it’s the people we have to think about.  For the doctors in this country, those people are our patients, our friends and our families.  And I suspect that many of those doctors are willing to take that next step and join in partnership to do what must be done.

 

Mr. President, thanks for coming to Chicago.

Filed Under:

Cancer Care | Treatment

My Kingdom For A Pen: Who Is Kidding Who?

by Dr. Len June 03, 2009

I realized last night while reflecting on the annual meeting of the American Society of Clinical Oncology that concluded yesterday in Orlando that my luggage on the trip home was much lighter than in years past. 

 

The reason?  New pharmaceutical regulations prohibited the drug companies from giving me “anything of value,” namely pens, bags, calendars or whatever they could come up with to give to me and other attendees at the conference to gain attention for their products.

 

I must admit that I now feel much more pure than I have in years past, and much less conflicted since I haven’t been able to gather my supply of pens for the coming year.

 

But there is another side to this story; a story of unintended consequences that has not been told and that may have far reaching implications for clinical practice and even for groups like ours that work to defeat cancer.

 

If I seem a bit cynical about this, it’s because I am.  While I can’t get a free pen, I have colleagues out there who are paid a lot of money to speak on behalf of these same companies, “consult” for the companies, and do other activities that provide a substantial income.   But I can be swayed by a pen.  Folks, we need to get real here.

 

If truth be told, I never spend much time in the exhibit area at these meetings.  And, I really don’t take much of this stuff passed out by the drug companies, some of which can be very useful.  It just doesn’t interest me and I would sooner pay for my own pens anyway.  I must also admit that many of my colleagues like these things.  I particularly remember one year where the meeting rooms were filled with large bright yellow rolling bags boldly emblazoned with the name of the drug company and their highlighted product.  Sales zoomed shortly afterward, although I have no evidence that the yellow bags truly made that happen.

 

Here is what ASCO wrote in their daily newspaper last Saturday about these new bans on “giveaways”:

 

“For this year’s Annual Meeting, ASCO changed its policies for exhibitors in order to comply with the rules governing marketing practices in the 2009 Pharmaceutical Researchers and Manufacturers of America (PhRMA) Code. The changes will enhance the ASCO Annual Meeting educational experience and allow all exhibitors an equal opportunity for delivering a substantive, informative message to attendees.

“Under the new policy, all promotional items used by commercial exhibitors must be designed primarily for the education of patients or health care professionals. Items such as textbooks, informational CDs or brochures, and journal reprints all are considered acceptable for distribution. Noneducational giveaways, such as pens or mouse pads, are permitted only for patient advocacy groups and other nonprofit exhibitors. According to a press release from PhRMA, the 2009 code recognizes that, despite the minimal value of these noneducational items, they ‘may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues.’ ”

 

Let me be clear: I don’t blame ASCO for this.  These rules apply to—and are affecting—every medical meeting in the country.

 

This is a story that has received some attention in the national press.  Yesterday’s Wall Street Journal Health Blog had an article which noted that the traffic in the exhibit area at the ASCO meeting was down considerably from past years, which confirmed my own anecdotal impression.

 

The doctors visiting the exhibit area may have been fewer in number, but the booths (if we can call them that) the drug companies built for the conference were pretty spectacular.   And some of the companies even had separate booths, one for a doctor to speak to a representative, and another one far away (about half a city block) if there was a question about drugs currently under development and not yet approved by the Food and Drug Administration.

 

And the “little rooms” I wrote about last year appeared to be gone as well.  Instead, there were wide open lounges labeled “international,” right next to other lounges labeled United States.  You could get a pen or another “promotional item” in the international area, but not in the United States section.

 

Now the other  side to this story, the part that shows even the best intentions can have some not so good results.

 

In a comment on Twitter this morning, Jessica Arnold—who is the Director of Development for the National Children’s Cancer Society—wrote, “ASCO was a disappointment.  Didn’t have the exposure we did last year.  New pharma regs had larger impact than people thought—even for charities.” It appears fewer giveaways meant less traffic on the floor, which meant less chance for doctors to interact with advocacy groups and others, and perhaps fewer opportunities to learn about areas of oncology that could help their practice and their patients.

 

And it goes beyond ASCO.

 

I happen to be involved in a number of medical organizations, both state and national in focus.  The reality—for better or worse—is that pharmaceutical companies have spent considerable sums supporting these organizations and their annual meetings, even smaller statewide educational meetings here in my home state of Georgia.

 

In one particular situation recently, one of those groups I work with could not get pharmaceutical companies to buy booth space.  Their rationale was that since they couldn’t give anything away (and in this situation, I promise you the value of the “gifts” was very, very modest and didn’t exceed a keychain or a pen), they felt they couldn’t attract attention to their booth.  No booth, no payment to the organization, and the net result was a substantial financial loss for the meeting.

 

The sad reality in this circumstance was that the meeting really was educational, with great lengths taken (as currently required by the agency that grants educational credits to doctors for attending these meetings) to avoid any influence from any drug company.  Now, without funding for this multi-day educational session—which may be the one continuing educational gathering that some doctors attend for the year—there may not be the financial support necessary to continue the meeting.  It would be prohibitively expensive.

 

You may not think that is a problem, but for some of us well-meaning, ethical physicians, it is.   And it comes down to pens and key chains, which may itself seem ridiculous.

 

But it is the implication that I can be bought for a dime that really bothers me and my colleagues.  Yet when a research paper is presented at ASCO and every author (and there were many on this particular report) are either stockholders in the company, employees of the company or receive considerable compensation from the company, no one raises an eyebrow. It is simply the way business gets done.

 

This issue is not going to go away.  But reducing it to a promotional pen reflects how far we have come, and how far the consequences of these “regulations” have yet to take us.

Filed Under:

Cancer Care | Medications | Treatment

Megadatabases: The Future of Cancer Research?

by Dr. Len June 02, 2009

Sometimes research reports are as interesting to me for the story behind the story as much as the actual story itself.  Such is the case with two abstracts presented at the annual meeting of the American Society of Clinical Oncology here in Orlando, which closes today.

 

The two reports deal with the impact of anti-depressants on the effectiveness of tamoxifen, a drug that has been used for decades in the adjuvant (preventive) treatment of breast cancer after surgery and radiation, as well as for the treatment of breast cancer that has spread to other parts of the body.

 

But the “story behind the story” is that the research was done through the analysis of large medical data banks, one of which is owned by a public company which happens to be a major prescription benefit manager here in the United States. 

 

The relatively recent development of these megadatabases will, in my opinion, become something we will see used more and more in health care going forward, hopefully for good purposes.

 

First, the concept behind the research:

 

Tamoxifen is a drug which is commonly described as an “anti-estrogen”, and essentially blocks the effects of estrogen on breast cancer cells which are hormonally sensitive, or estrogen positive on biopsy.  There is an enzyme in the body which converts tamoxifen into its active form.  The levels of this breakdown product in the blood directly predict the effectiveness of the drug in treating the cancer.  Some women do not have this enzyme, so they have lower levels of this “converted” form of the drug, and therefore do not get as much benefit.

 

There are also some drugs which are known to block this particular enzyme that breaks down tamoxifen.  The enzyme is called CYP2D6.  Among those drugs are anti-depressants.  Women take anti-depressants not only for depression, but also because they are effective in treating the symptoms of menopause and may also block the menopausal-like symptoms associated with tamoxifen.

 

In one of the studies, researchers in the Unites States used the prescription records of their company to look at the question of whether women who took both tamoxifen and certain anti-depressants had poorer outcomes with their breast cancer compared to women who only took tamoxifen.  They reported that women who took both drugs had a recurrence rate of 13.9% over two years, while women who took only tamoxifen had their breast cancer recur at a lower rate of 7.5% over the same time period.

 

In the other study, which was from the Netherlands, the researchers used their national health system records to determine that among 2000 women with breast cancer using tamoxifen from 1994 to 2006, 215 also used a drug that could inhibit the CYP2D enzyme.  However, unlike the United States study, they did not find that the women fared poorly if they took an anti-depressant.

 

There are reasons why the studies may differ in their outcome, but the net result is that we still don’t know for certain whether or not it is safe to use the drugs together.  The Dutch study clearly looked at women who used tamoxifen for the adjuvant therapy of breast cancer, and they also had computer based medical records which are likely more specific in defining when the breast cancer recurred.

 

The United States study examined the computer records of women  with breast cancer who started taking tamoxifen between 2003 and 2005 and took the medicine for over two years.  There was no independent confirmation of medical records, and no independent confirmation that this drug was used for adjuvant therapy.  Recurrence was determined based on medical insurance claims that used certain codes to suggest that the disease had progressed.

 

The other interesting point about the United States study was that the database used in the research was developed as part of the actual daily business model of the pharmacy benefit manager.  It contained the records of 10.7 million health plan members for whom the company administered the drug benefit portion of the client companies’ insurance program.  The information was “deidentified,” so the researchers could not link the record to any specific patient, and could only look at the larger trends.

 

Using these large megadatabases for medical research and improving medical care has intrigued me for some time.  What you may not know is that insurers, health plans, pharmacy benefit managers, health information technology companies and large medical group practices are now accumulating this data at an accelerating rate.

 

Although this information has long been used for business purposes and to some degree to manage the medical care of the patients included in these databases, the opportunity to mine this information for research purposes and looking at medical care trends is only now beginning to take hold.

 

The opportunities are—in my opinion—enormous.  If we could get these databases to operate in “real time,” they could be used to look at potentially alarming trends in illness, such as the recent flu outbreak, to get an early warning signal about a rapidly spreading epidemic.  They could be used to find unexpected side effects from drugs, as we have seen with medicines such as blood-thinners which can result in an increased number of emergency visits.  The Food and Drug Administration is beginning a pilot program to test the theory that we may be able to use these large databases to screen for side effects from new and established drugs that are on the market, to find out if there are serious unanticipated problems.

 

For me, the dream has always been to establish seamless health care monitoring systems that help us improved the quality of care we offer our patients.  For example, did an eligible woman have a mammogram? Was it positive or negative? Did she get a biopsy? How long did it take to get her surgery? What surgery did she have? Did she get the right follow-up treatment? And did she come back the next year for her follow-up?

 

We could also monitor physician performance, and get away from the crude measures we use today to really determine in some circumstances whether or not doctors meet certain standards.

 

For example, in the above scenario, how about measuring the performance of the radiologist doing the mammogram?  How many mammograms does the doctor read a year (the number read is an indicator of quality.  Too few is not good.)? How many mammograms does the doctor read as positive?  How many biopsies are performed because of the doctor’s interpretation of the mammogram?  How many were positive? How many were negative?  Does the doctor miss too many lesions that subsequently are diagnosed as cancer?

 

So, here we have some research studies that unfortunately don’t give us a clear answer to the question about the use of anti-depressants in women with breast cancer who take tamoxifen. 

 

But we do have a window on the future as to how we may get clues about the problems we face in health care, and perhaps develop a more rational, less intrusive way to spot early safety signals about our drugs and treatments, while at the same time be able to finally measure the quality of the health care we provide in real time.

 

I feel compelled to add that I don’t think we are not there yet.  Even in the United States study described above the researchers had to rely on what we call “administrative claims data,” which is frequently not as accurate as we would like.  It is also one very large step away from the actual “source” data which is the medical record.

 

But make no mistake: the next decade will see a substantial increase in the availability of this type of information.  The real question is whether we have the skills to use that data wisely and effectively to improve the care we offer our patients.

Filed Under:

Breast Cancer | Research | Treatment

New Hope In Treating Triple Negative Breast Cancer

by Dr. Len June 01, 2009

One of the papers presented during yesterday afternoon’s plenary session at the annual meeting of the American Society of Clinical Oncology (ASCO) captured my attention for a couple of reasons.

 

The study reported on a new drug code named BSI-201 in a trial where the researchers treated women with a form of breast cancer called “triple negative.”  Triple negative breast cancers (or TNBC) are called that because they don’t have estrogen or progesterone hormone receptors and are negative for a genetic marker called HER2. As a result, they can’t be treated with some of the more successful breast cancer treatments such as hormonal therapy or targeted drugs such as trastuzumab (Herceptin ™),  They tend to occur in younger women and especially in African American women.  Unfortunately, they tend to be more aggressive than other forms of breast cancer.

 

This new drug acts against something called poly(ADP-ribose) polymerase-1, or PARP-1.  If you think that is a mouthful and don’t understand what it is, don’t feel bad.  Neither do I and neither did much of the audience at yesterday’s presentation.  In fact, this was so new to the doctors in the audience that they had a special tutorial in PARP-1 before they presented the data from the paper, so everyone could learn something about the science behind the drug.  Basically, this enzyme is involved in gene repair and cell proliferation, two key targets to control cancer cells.  BSI-201 inhibits PARP-1, and it is thought that it works best by adding it to certain chemotherapy drugs as opposed to using it by itself.

 

In this trial, women with TNBC with metastatic disease—a particularly difficult situation to treat—received chemotherapy with two drugs (gemcitabine and carboplatin).  Half the women received just the chemotherapy, and the other half received the drugs with the addition of BSI-201.

 

The results, in my opinion, were impressive: 62% of the women who got BSI-201 responded to the treatment compared to 48% in the “control” group that got just the standard therapy.  The time it took for the disease to progress on treatment in the women who received BSI-201 was 6.9 months, compared to 3.3 months for the women on the standard treatment arm.  The overall survival increased from 5.7 months in the control arm to 9.2 months in the BSI-201 arm.  There was no apparent increase in side effects from adding BSI-201 to the treatment program.

 

Those improvements are all significant, although obviously don’t represent the types of increased survivals we would like to see.  But as I mentioned, women with TNBC who have metastatic disease unfortunately don’t do well with current treatments, and this new drug represents a true ray of hope in a frequently hopeless situation.  I would also note that some of these women had already received prior chemotherapy, which in effect stacked the deck against seeing any success with this new drug regimen.

 

I was so intrigued by the results that I tried to find out more about the company that invented the drug.  The name of the company is BiPar Sciences.  You would think that this would be a large company to have made such a significant discovery of a drug that represents an entirely new class of therapy.

 

What I found out was that in fact the company had recently been purchased by a larger pharmaceutical company, so it is no longer a “stand alone.”  I also was told that the company still pretty much works on its own, free of much of the constraints that usually come along with being part of a much larger organization.  The number of employees who worked on this exciting discovery and clinical trial?  About 20, according to my source.

 

And, on another front, it appears that this clinical trial was done in large part through member practices of US Oncology, a nationwide oncology practice organization, not through a major university or university consortium.  So it reinforces the fact that private practices (and their patients) that commit to clinical cancer research can make significant contributions to advancing our knowledge and capabilities in cancer care.  If we could see more of this type of commitment and participation by non-academic, community based oncologists we could dramatically increase access to clinical trials and get more cancer drugs tested nationwide.

 

So here we have one of the more exciting advances in chemotherapy that I have seen in a while, and it didn’t take a giant company or major universities to get the job done.

 

For women with TNBC there is now a bit more hope that we can help them in their time of need.  The trial reported here at ASCO was what we call a phase II trial, which is essentially early stage proof-of-concept.  The next step is a phase III trial, which will treat more women, and that is scheduled to start this month.  The drug is also under investigation in other cancers as well.

 

Here's hoping that this research opens the door to a new and exciting frontier in cancer research and cancer treatment.  It clearly looks that way to me.

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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