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Doctors Communications to Patient’s Family

By Michael D. Miller MD
February 10th, 2010

The great writer John McPhee’s article in the February 8th issue of the New Yorker is primarily about his experiences fishing for pickerel in New Hampshire, but the subtext is his connecting to his dying father who is in the hospital after a severe stroke.

While the article is extremely warm and heart-felt, two short sections stand out because of his visceral reaction to his father’s doctor:

“His room had a south-facing window.  My mother, in a flood of light, eighty-seven, looked even smaller than she was, and space was limited around her, with me, my brother, my sister and a young doctor together beside the bed. I was startled by the candor of the doctor.  He said the patient did not have many days to live, and he described cerebral events in language only the patient, among those present, was equipped to understand.  But the patient did not understand: ‘He can’t comprehend anything, his eyes follow nothing, he is finished,’ the doctor said, and we should prepare ourselves.

“Wordlessly, I said to him, ‘You fucking bastard.’ My father may not have been comprehending, but my mother was right there before him, and his words, like everything else in those hours, were falling upon her and dripping away like rain.  Nor did he stop. There was more of the same, until he finally excused himself to continue on his rounds.”
……
“The young doctor returned, twenty-four hours exactly after his earlier visit. He touched the patient with his fingers and steel, and qualified for compensation. [emphasis added] He said there had been no change and not to expect any; the patient’s comprehension would not improve. He went on as had the day before.  My father, across the years, had always seemed incapable of speaking critically of another doctor, perhaps in a paradoxical way, because he had been present in the operating room where the mistake of another doctor had ended his mother’s life. Even-tempered as he generally appeared to be, my father could blow his top, and I wondered, with respect to his profession, to what extent this situation would be testing him he were able to listen, comprehend, and speak.”

To be fair - and maybe overly fair - perhaps the physician taking care of Dr. McPhee was focused on the outcome of his patient, and realizing that improvement would not happen wanted to set realistic expectations for the family. However, what is clear from John McPhee’s prose is that the physician didn’t see the patient’s family within his care continuum.  He didn’t treat them as if they were his patients who needed his compassion.  If he had, he might have realized that while he - and medical science - could do very little for Dr. McPhee after his stroke, there was a lot that he could do for the family by being more compassionate and empathetic in his interactions as he was explaining the diagnosis and prognosis.

In addition - although John McPhee doesn’t mention it in his article - hopefully there were other components of the care team besides the one physician, since a well-coordinated care team should provide additional information and support to the family.  It would be unrealistic for a single physician to provide all the information and support to a critically ill patient and their family - even when there is no hope and no interventions to ease the patient’s condition. Expecting a physician to do all this alone is like asking an NBA basketball player to go 1 on 5 against another team.  Even the greats of Chamberlain,  Jordan, or Bryant wouldn’t have been able to do that.

I applaud John McPhee for his great writing and for including his direct feelings about his encounter with the medical care system.  His article would be good reading for clinicians in training and practice since it so deeply illuminates how patients and their families can view clinicians, their words, and how they deliver them. Similarly, his article would be a great reading for students and policy makers interested in the relationships and communications between clinicians and patients - and their families - as well as for those interested in improving compassionate caregiving.

Posted in Clinician-Patient Relationships, Delivery of Healthcare, Information & Communications | 2 Comments »

Congressional Accomplishments for 2009

By Michael D. Miller MD
February 9th, 2010

Why the Democrats are increasingly becoming politically vulnerable is a topic that pundits are dissecting in great detail.  A general consensus is that the root cause of the public’s growing discontent is a lack of progress on the economy and jobs.

While the economy and the job market have stabilized somewhat - even if they haven’t rapidly rebounded - the President and Congress haven’t gotten much credit for not letting the ship sink.  In addition, most of the President’s and Congress’ major accomplishments occurred in the first part of 2009, while towards the end of the year the focus shifted to the very slow moving health care bill - which also included many real and concocted controversies.

Even the most recent Saturday Night Live’s Weekend Update took a shot at the lack of accomplishments by quickly scrolling past these three items:

  • Cash for Clunkers
  • Defunding the F-22
  • Credit Card Accountability Act

However, National Journal’s January 16th issue had a side-bar with a much more extensive list of 2009 accomplishments:

  1. Protections against wage discrimination (President signed on January 29)
  2. Expansion of the State Children’s Health Insurance Program (signed on February 4)
  3. The economic stimulus package (signed on February 17)
  4. A fiscal 2009 omnibus appropriations bill covering unfinished work from the previous Congress (signed March 11)
  5. A public lands package designating more than 2 million acres as protected wilderness (signed March 30)
  6. Expansion of national service programs (signed April 21)
  7. A fiscal 2010 budget resolution (Congress approved on April 29; President does not sign)
  8. Home mortgage reforms and foreclosure assistance measures (signed on May 20)
  9. Curbs on abusive credit card practices (signed on May 22)
  10. Pentagon acquisition reforms (signed on May 22)
  11. Sweeping tobacco regulations (signed on June 22)
  12. A fiscal 2009 supplemental appropriations bill to fund the Iraq and Afghanistan wars, flu-prevention efforts, and the “cash for clunkers” auto-rebate program (signed on June 24)
  13. Confirmation of Sonia Sotomayor to the Supreme Court (sworn in on August 8 )
  14. The fiscal 2010 Defense authorization bill, including an expansion of hate crime laws to cover offenses based on a victim’s sexual orientation, gender identity, or disability (signed on October 28)
  15. Extensions of unemployment benefits and the homebuyer tax credit (signed on November 6)
  16. The fiscal 2010 appropriations bills (signed on various dates in October and December)

So while the SNL skit was good comedy, it only picked up 3 pieces of 16 substantive Congressional actions - which were not just political talking points that could be written on the palm of a hand.

Palin Hand’s Crib Notes - Tea Party Convention February 2010

The bottom line seems to be that the President and the 111th Congress got handed a bucket of turds at the starting line, (e.g. crashing economy, dramatically deepening Federal deficit, and two wars),  and they’ve been aggressively trying to keep things from stinking too much while making as much fertilizer as possible.

But no matter how much sugar and sweet smelling spices anyone could toss over the bucket, it still has a bunch of turds.  Despite the progress made and the sweeteners tossed about to help people and companies maintain themselves through the economic crisis, the public still perceives that something is rotten and smelly with the government, (as well as financial institutions and some other large companies and organizations), and their response is to want to throw out anyone they can connect to the ongoing stink.


 

 

 

 

 

 

 

 

 

Posted in Information & Communications, Miscellaneous, Politics | No Comments »

What “Will” Happen With Health Reform

By Michael D. Miller MD
November 29th, 2009

With the Senate scheduled to start debating (and likely amending) health reform legislation this coming week, speculation is rampant about what will happen with health reform.  Since the title of this blog is “health policy and communications,” I want to focus on the use of language in discussing health issues, studies, proposals and legislation - specifically the word “will.”

The word “will” is very strong and it implies a high degree of certainty about predicting future events, such as “The Sun will come up tomorrow morning.”   And while I have no problem with predicting the future - as my friends know, I have a great reputation for predicting the future, particularly about sporting events like fake punts and winning 8 straight games to win a World Series - but using the word “will” to describe the implications of scientific studies, or legislation and policy proposals, can be misleading.

Specifically, the word “will” is often used loosely as a stand in for the phrases, “is projected to be” or “is estimated to be.” For example, in a recent press release for a study about diabetes in the US it was reported that, “The diabetes population in the United States will almost double over the next 25 years…” Interestingly, the next part of that sentence states, “and annual medical spending on the disease is projected to hit $336 billion, up from $113 billion today…”  So apparently future costs can only be projected, but future cases of diabetes can be predicted with much greater certainty. [emphasis added]

Assumptions v. Future Reality
The reason to be concerned about the use of this type of language is because although the methodology for any study or projection may be valid and reasonable, its conclusions are only as good as its assumptions. And as ever researcher and policy person knows, many, many, many things can occur that cause reality to differ from what is projected based upon those assumptions - particularly over the course of 25 years. Think about it, how accurate do you think the predictions about 2009 were in 1984?

Media Contributes to Impression of Inevitability with Language
The media also tends to propagate some misleading impressions.  For example, the phraseology about the implications of the diabetes study was copied by multiple new sources - such as Time Magazine - and even expanded upon by the Chicago Tribune to imply that costs will also dramatically increase, “…diabetes cases will nearly double in the U.S. in the next 25 years and the cost of treating the disease will almost triple…” and CNN, “The number of Americans with diabetes will nearly double in the next 25 years, and the costs of treating them will triple…”[emphasis added]

What Will Happen With Legislation
It is also common so see the word “will” used when referring to legislation.  Many politicians and pundits use it in asserting that various bills and provisions “will do” something specific, such as expanding coverage, controlling costs, etc… when actually they are referring to projections or estimates - often from the Congressional Budget Office which is generally very careful about describing their work as projections or estimates.

The reason politicians, pundits, and others use the word “will” is because it is very effective in rallying support for (or against) specific bills or proposals, since it increases the impact on the listener (or reader), makes them feel more concerned about the issue, and increases the likelihood that they will  take some desired action.  Thus politicians and PR people use the word “will” rather than “projected” or “estimated.”  So the next time you hear a speech or news report about legislation that states the bill “will” do something in terms of changing the number of people with some benefit, or it “will” cost or save so much, substitute the phrase, “is projected to” for “will” in your mind, and see how much less impact and traction the message has - and you’ll see why the word is used.

The only drawback for politicians of making such statements, is that 5-10 years later when the actual results are different than what was projected or estimated, there can be rhetorical battles about why someone “promised” that the legislation “would” do something, yet the actual results were different.  (A great example of this was the provisions in the Balanced Budget Act of 1997 that were intended to expand options for Medicare HMO plans, but it actually reduced the options for such plans.)

Next Up: Implementing Health Reform - What Will Happen

Posted in Access to Healthcare, Information & Communications, Politics | No Comments »

Thanksgiving Conversations About Health - Engage With Grace Blog Rally

By Michael D. Miller MD
November 24th, 2009

For many years I’ve used the Thanksgiving dinner table conversation as a model for discussions about healthcare - but usually I’ve put it in the context of people who work for healthcare companies, (e.g. pharmaceutical or managed care), trying to address, rebuff and rebut the criticisms they might get from family members, (e.g. Aunt Lilly), about the problems with the US healthcare system and the actions or positions of various companies or industries.  However, last year - and again this year - several bloggers have been cooperating to promote Thanksgiving weekend discussions about end of life care issues.  This effort has been called the Engage with Grace, and last year it was a great success, with over 100 bloggers participating.

The original mission of this “blog rally” was to get more and more people talking about their end of life wishes. But because this year has had quite intensive public debate about health reform, the decision was made for this year to do something a bit different and add a bit of levity to the efforts to promote discussions.

At the heart of Engage With Grace are five questions designed to get the conversation started, but to put a slightly lighter spin on these questions, the first set below has a less serious tone - the “real” Engage With Grace questions are at the end of this post - and I’ve interjected five other humorous ones in between. They’re not easy questions, but they are important - and the goal of both the serious and lighter questions are to get people talking, since if you can’t talk about the funny questions, then how can families and friends expect to seriously talk about the difficult and important ones?

Engage With Grace Questions - Set 1

  1. Which one of your family members would you trade for a celebrity or professional athlete, and who would you trade them for?
  2. After you made that trade, would you want the celebrity or professional athlete to cook or do the dishes at your holiday meal?
  3. Would you want that celebrity or professional athlete to be on your post holiday meal team for Charades or Monopoly?
  4. Would you want that celebrity or professional athlete to be named on your advanced directive or living will so they could make decisions about your healthcare needs and choices if you were unable to do so?
  5. Would you want that celebrity or professional athlete to represent you in the US Congress to make decisions about Medicare and health reform?

Engage With Grace Questions - Set 2

Have a good holiday season - and go with grace.

Posted in Clinician-Patient Relationships, Delivery of Healthcare, Miscellaneous | 3 Comments »

Off-Label Communications: Is More Less?

By Michael D. Miller MD
October 4th, 2009

Allergan corporation has filed a law suit against the Federal government challenging the FDA’s limits for companies discussing or promoting off-label uses of approved medicines.  This is not a new issue, but the news reports indicate that Allergan is going very old school and basing their legal challenge on Constitutional freedom of speech rights.

The issue is not can doctors and patients use approved medicines for conditions, (or in ways), which are not specifically approved by the FDA, but can companies discuss these off-label uses with physicians or provide them with published information about these off-label uses?

Competing Risk-Benefit Perspectives
The competing risk-benefit perspectives that surround this issue are nearly identical to the trade-offs that all stakeholders in biomedical research and development face - including the FDA, companies, patients, clinicians, and legislators:

  • Creating a landscape that protects individuals and public safety
  • Being flexible enough to provide clinicians and patients access to the best available treatment possibilities
  • Providing companies a reasonable market environment that creates incentives for developing new treatments and investigating new uses for already approved medicines, which also has marketing rules that are as clear as possible so companies can conduct business without being excessively concerned about straying into regulatory gray zones

Off-label use is common in clinical practice - particularly for disease areas like cancer - because it often represents the standard of care.  And in situations where a medicine approved to treat a common condition has an off-label use for a rare condition, the company has very little incentive to conduct the expensive and time-consuming clinical research to get the FDA to approve that rare off-label use.

There are a few key points underlying the issue of communicating information about off-label uses:

  1. The Constitutional freedom of speech rights for a company are not as expansive as for an individual
  2. The FDA’s regulatory authority focuses on the approval for sale and marketing of medicines, (and some other product areas), and not their use in clinical practice - with some very rare exceptions
  3. The FDA’s position about companies disseminating information about off-label uses has not be fixed in stone

On this last point, the 1997 FDA Modernization Act included a provision to expand the ability of companies to give physicians journal articles and similar material about off-label uses of approved medicines.  After that the Washington Legal Foundation brought a law suit seeking to expand off-label information dissemination.  And when the FDAMA provisions expired in 2006, the FDA proceeded with rule-making guidance to replace the FDAMA provisions, and this final guidance became effective in January 2009.

Not having read the details of Allergan’s legal challenge - and since the FDA doesn’t comment on current suits - it’s hard to assess the specific pros and cons of their positions.  But considering the extensive legislative and case law involving this issue, the company certainly seems to have a very steep hill to climb.  On the other hand, it would seem unusual that they would spend the time and money to bring a legal challenge unless they felt they had a chance to prevail. However, Allergan’s suit may have implications for the FDA, industry, clinicians, and patients for several or many years - even if they lose - because they may be making a pretty big splash in the policy pond with such a public challenge to change the rules for off-label promotion, and this will likely alter the landscape for any future actions.

I was involved with a somewhat analogous situation in the mid-1990s where a lot of groundwork had been done to prepare for a substantive debate about reforming a fundamental life sciences policy issue.  However, one company had an urgent and particular need for a legislative change, and they proceeded to pursue every reasonable and extraordinary avenue for getting the change they wanted.  The end result was that all our subsequent discussions were short-circuited because every policy stakeholder’s response upon raising this issue, was “Oh, I know about THAT issue,” with the implication that it was something they wanted nothing to do with because of the controversy the one company had stirred up with their expansive activities.  (I’ve purposefully not named the issue so as to not perturb anyone or any company about something that happened years ago.)

Collective Sausage Making
The moral of this story is that to make productive changes stakeholders within and across groups frequently need to work together. And if they don’t, the well can easily get polluted for everyone when policy makers avoid any action because they connect the issue to a nasty smell.  This may be another manifestation of the old adage, “the two things that shouldn’t be seen being made are laws and sausages.”

Happy Sausage Making - 2009

Posted in Delivery of Healthcare, FDA, Information & Communications, Quality of Care & Safety | No Comments »

Encouraging Communications About Patients’ Goals

By Michael D. Miller MD
September 18th, 2009

I attended a great event yesterday where experts discussed how to improve healthcare quality and safety by increasing patients’ involvement in making healthcare decisions.

This seminar, “Patient-Centeredness and Patient Safety: How Are They Interconnected,” was organized by the Kenneth B. Schwartz Center and sponsored by the Massachusetts Medical Society and CRICO/RMF.  Don Berwick (President & CEO of the Institute for Healthcare Improvement) was the main speaker followed by a panel consisting of two patient safety leaders from local hospitals and a patient involved with promoting patient engagement in quality improvement.

To start the event, Dr. Berwick discussed how his thinking about healthcare quality had evolved over several decades, and his increasing belief in the importance of patient involvement. He discussed his Health Affairs article on Patient-Centered care, and summarized his current thinking about how to design patient-centered care in 8 bullets:

  1. Place the patient at the center
  2. Individualize
  3. Welcome family and loved ones
  4. Maximize health influences within care
  5. Maximize health influences outside of care
  6. Rely on sophisticated, disciplined evidence
  7. Use all relevant capabilities - waste nothing
  8. Connect helping influences with each other

Communications Is Crucial for Achieving Patient-Centerdness and Goal Sharing
The essence of the panel’s discussion was about how to improve communications among patients and their clinicians so that each others’ goals were shared and understood.  One example raised by a panelist was initiatives to prevent patients from falling in the hospital.  Patients may see nurses being in bathrooms with them as intrusive or uncomfortable, but discussing their shared goal of not having patients fall and hurt themselves shifts the context of the nurse’s action and enables it to be embraced by the patient rather than resisted.

From the patient’s perspective too often clinicians may have their own ideas about what the goals of the treatment should be, but without understanding the patient’s life interests and goals the two may be disconnected.  For example, clinicians often ask patients what they do for work to understand if the treatment or the outcomes will be compatible with their jobs, but often patient’s happiness or life fulfillment is related to something outside of work, such as playing the piano, playing with grandchildren, rollerblading, hiking with their dogs in the mountains, or hang-gliding.  Treating a patient’s injury or illness so they can do (or be able to try to do) those activities may be very different than what would be indicated if the goal was to enable them to work in an office.

Creating Policies to Promote Communications and Goal Sharing
Dr. Berwick’s presentation also included a brief discussion of how evidence based medicine (EBM) can improve patient safety by avoiding unnecessary care and setting realistic expectations about the outcomes for chosen treatments.  This is captured in his 6th bullet above. One of the challenges in the current push towards more EBM - and comparative effectiveness research (CER) - is what to actually measure in this research. Combining the health system’s desire for optimal outcomes with patient-centeredness, (i.e., his 2nd bullet - “Individualize”), could be achieved by including the patient’s goals for their treatment as one of the outcomes measured in EBM and CER programs.

Benefits of Measuring Achievement of Patients’ Goals as an “Outcome”
Process measures, (such as percentage of patients who’ve received a recommended treatment), are usually easier to evaluate, but are really proxies for clinical outcomes.  Actual outcomes like mortality or hospitalization can be harder to evaluate, in part because of individual patient differences and thus the raw data needs to be risk adjusted. However, measuring achievement of the patient’s goals could be very important and valuable to add to these evaluations - and could be a rough way to inherently risk adjust the data, i.e. the “goals” of treating a broken hip may be different for a 50 year old person than someone who is 70.  The actual measurement of such goal achievement could be done based upon answering the question of “how well were the patient’s goals met?”  Clearly this would have to be quantified in some way - and perhaps that could be done by the patients themselves on an 11 point scale from 0-100%.

Not only would measuring this “patient goal achievement” outcome add a useful dimension to some research, but it would also put the question of “what are the patient’s goals?” right at the front of the patient-clinician conversation.  And in the context of health reform and system improvement, by using the dictum of, “we manage what we measure,” measuring how well delivery systems and clinicians are achieving patients’ goals could be an important force for transforming care delivery.

Bottom Line for Patients and Clinicians
The next time you’re a patient talking to a clinician, be sure to talk about your goals for treating whatever ailment caused you to see that clinician.  And clinicians need to tell their patients what goals they expect to achieve from the treatment they’re recommending.  This is the start of a conversation since the patient’s expectations may not be realistic - such as for a patient with a severe fracture who wants to run a marathon in three weeks.  But by understanding each others goals and expectations they can agree on what should be done and how to proceed.

Need for Continuity of Care and Primary Care Clinicians
Of course some patients may seek to “doctor shop” looking for a clinician who will promise to achieve their goals.  This can be good if the first clinician isn’t attuned to the patient’s wishes, but it can also be bad if the patient’s expectations are unrealistic.  That is why having a trusted relationship with a primary care clinician can be so important, since their PCC can help them evaluate and digest other clinicians’ recommendations.  Again, it comes down to ongoing and two-way communications to understand goals and jointly develop treatment plans and decisions.

Posted in Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Information & Communications, Quality of Care & Safety | No Comments »

Miscommunicating Health Reform

By Michael D. Miller MD
August 14th, 2009

Anyone following the debate about health reform knows that the discourse has become increasingly uncivil.  While it is easy to blame those opposing the proposals being developed in Congress for this situation, supporters of the proposals have been validating their adversaires’ messages by repeating the misrepsentative labels in their rebuttals.

Specifically, critics of the overall proposal have mischaracterized a provision that would pay clinicians for discussing end of life care preferences with their patients enrolled in Medicare.  (See below for information about the provision.)  Unfortunately, in responding to these attacks, health reform supporters have repeated the false claims about the provision, (and the label “Death Panels”), and thus perpetuated the fear their opponents have created.

The problematic nature of the messaging by health reform proponents has even been highlighted by the newsamedian Jon Stewart, who noted on his Daily Show, “You know a sales pitch is in trouble when it starts with, ‘Look, you gotta trust me, we’re not going to kill your grandparents.’”

Using Campaign Strategies Against “Death Panels”
While the Administration has adopted a campaign-style strategy to support health reform, unfortunately, they haven’t also consistently applied campaign communications strategies  - particularly the rule about not naming your opponent, i.e. referring to that person as “my opponent” rather than by name, so that their name doesn’t get additional public or media exposure.  Therefore, saying “death panels” in explaining why they don’t exist  violates this rule because it helps perpetuate the label and provides the media with video of leading advocates uttering that phrase.  This perpetuates the opponents message, giving it longer and larger life, and preventing advocates from talking about the positive aspects of the proposals they support.

Power of Positive Messaging
A much better strategy is to describe the positive aspects of mischaracterized provisions without referring to the false label.  In this case, that would involve explaining that the allegedly controversial provision is an extension of - and an improvement upon - current Medicare law, and it is  designed to strengthen patient-physician relationships and communications.  (Current Medicare law* requires hospitals, nursing homes, hospice programs, home health agencies, and HMO’s to give adult individuals, at the time of admission or enrollment, information about living wills.**)  The proposed provision improves upon current law - which can be fulfilled by handing a person a stack of papers - because it would encourage clinicians to talk to their patients about their wishes involving serious medical problems BEFORE they occur.

——————————————————————–

Footnotes:
* This part of Medicare law was created in 1990 as part of the Patient Self Determination Act -  which was included in the Omnibus Reconciliation Act of 1990.
** “Living wills” are also referred to as advanced directives or durable power of attorney for healthcare.  These documents express the individual’s preferences for certain types of health care interventions, and empower a person (or persons) to make decisions about their medical care should they be incapable of doing so themselves.

 ——————————————————————–

Summary of Section 1233 from HR 3200, “America’s Affordable Health Choices Act” (Full text of section available here.)

Sec. 1233. “Advance Care Planning Consultation.” Provides payment to clinicians for discussing with Medicare enrollees issues and their preferences - including the role of clinicians - related to life-sustaining treatment.  Payment will only be made for such consultations once very 5 years unless there is a significant change in the enrollees’ health. CMS will also modify the ‘Medicare & You’ handbook to incorporate information on end-of-life planning resources, and incorporate measures on advance care planning into the physician’s quality reporting initiative.

Posted in Health System Reform, Information & Communications, Politics | No Comments »

Unfortunate Diversion from Health Reform Message

By Michael D. Miller MD
July 23rd, 2009

It was unfortunate that President Obama answered the question about Professor Gates at his news conference last night because it has dramatically diluted the focus of his message from health care reform to this unrelated story.  Many news organizations are covering his remarks on that one subject with less recognition of his health care reform message.  While the Washington Post and NY Times lead with the health message, they also include articles about the Professor Gates.  Conversely, the Boston Globe (not surprisingly) and CNN.com highlight the Professor Gates story over healthcare.  (MSNBC.com and cbsnew.com have health reform coverage more prominently that the Professor Gates story, while abcnews.com and foxnews.com have Gates>health reform.)

Since the need for speed on moving health reform legislation through Congress was a large point the President was trying to make, this diversion has greatly diluted that message and shows how difficult and delicate message delivery can be about contentious issues - and how easily the media’s focus can be shifted from what you want to something else.  For example, I once had a series of media interviews about advances in treating heart diseases swept aside in a local area by coverage of the gangland style murder of the owner of a popular local fast food chain.

So while all the possible stories the media may cover can’t be controlled, keeping focused on the top health reform messages will be key for continuing to move legislation through the Congressional process.

Posted in Health System Reform, Information & Communications, Politics | 2 Comments »

Diabetes Updates - New Diagnostics, Increasing Rates, and Implications for Health Reform, CER, etc.

By Michael D. Miller MD
June 17th, 2009

Changes in the diagnosis and treatment of diabetes is a great example for understanding how healthcare delivery constantly evolves based upon new discoveries.  And the history of these changes may help illuminate some thinking about health reform and the development and use of comparative effectiveness research (CER).

First, a little background on diabetes.

Diabetes Background
Diabetes mellitus (or “sugar diabetes”) occurs when the body has problems regulating the level of sugar (specifically glucose) in the blood.  This can be because the body’s pancreas doesn’t produce enough insulin, or for some reason the person’s organs become resistant to the actions of the insulin that is present - or sometimes both occur simultaneously.  Impaired control of glucose means that the levels get too high, which produces problems in the eyes, (leading to blindness), in the kidney, (leading to kidney failure), and in the small blood vessels elsewhere in the body, which can lead to nerve damage and low oxygen delivery to the extremities - particularly the legs and feet, (leading to amputations).

In olden times, diabetes could be diagnosed by sugar in the urine.  (Medical lore says this was done by taste….)  However, until insulin was discovered in 1921 there were no therapies for severe insulin deficiency.  And even once insulin became available, sugar in the urine was still the way diabetes was diagnosed and monitored - usually with a dipstick that changed color depending on the sugar concentration.

It wasn’t until the 1960s that measuring blood glucose levels became possible - and only then in the doctors’ offices because the machines were large and expensive.  In the 1980s machines small and cheap enough for patients to monitor their blood sugar levels at home became available.  This enabled patients to start adjusting their own insulin dosages based upon their blood sugar levels.  (Before this it was too dangerous for patients to significantly alter their insulin dosages because while too little insulin leads to too high sugar levels causing long-term damage, too much insulin can drop sugar levels too low and lead to confusion, coma and death.)

In more recent years it was discovered that keeping diabetics’ sugar levels near normal could prevent essentially all the adverse consequences of diabetes, i.e. blindness, renal failure and amputations. But doing this based upon finger-stick blood sugar levels even 3 and 4 times a day was tricky - and those were just single data points.  So in the mid 1970s it was proposed that monitoring the amount of hemoglobin in the blood that had combined with glucose would give a measure of the average blood sugar level for the 2-3 month life of the red blood cells.  (It was known that glucose irreversibly connects to the hemoglobin in red blood cells in a way that directly correlates to the blood sugar level.)  This test, known as “glycosylated hemoglobin, (or HbA1C, or simply A1C), has been increasingly used over the past few decades to monitor diabetics and adjust their treatments, with the goal to keep A1C levels below 7%, since the level in people without diabetes is 4-6%.

Care Lags Discovery and Development of Innovations
Despite improved ability to monitor diabetes, it is still under diagnosed, and poorly managed.  It is estimated that there are about 6 million people in the US who have diabetes, but don’t know it - which is about 25% of all people with diabetes.  And in 2003-2004, only about 57% of people with diabetes had A1C levels <7%.  (The medical and lost productivity costs for all people with diabetes may be approaching $200 Billion.)

And the prevalence of diabetes is increasing - and with it so are the costs of treating people with diabetes. Last year I wrote about this, and now the CDC has updated information showing the continuing growth in the number of people in the US diagnosed with diabetes:

Increasing Rate Diabetes in the US 1980-2006
Source: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm

The treatment of diabetes has also changed.  After insulin was discovered, different forms and modifications where developed to change how quickly it acted, and beef and pork sources have been replaced with biotech “human” insulins grown in bacterial cultures. Many different types of non-insulin treatments for diabetes have also been developed - these act primarily by increasing insulin production from the pancreas or the action of the insulin in the body.

Which brings us back to the A1C test.  An International Expert Committee from the American Diabetes Association is now recommending that the A1C test be used to diagnose diabetes.  This would replace (or supplement) the traditional fasting blood glucose diagnostic test, and the A1C test would still be used for twice yearly monitoring of the adequacy of treatment for people with diabetes.

These developments in diagnosis and treatment have progressed in tandem - each leveraging off the knowledge gained from the other - with the A1C test being part of the continuing evolution of tests for diagnosing diabetes.  For example, the fasting blood glucose level for diagnosing diabetes has changed over the years.  It was originally set at 140mg/dl in 1979, and then lowered to126 in 1997, when it was also decided that a level between 110-126 should be considered pre-diabetic, or “impaired fasting glucose.” And in 2003 the lower bound for “prediabetes” was lowered to 100.

Why A1C Now?
While A1C testing has been used for years, there have been problems in standardizing the measurement. (This is discussed in the ADA paper linked to above.) But now A1C measurement inconsistencies, (which occur for all lab tests), have been narrowed sufficiently so that the ADA committee is recommending that an A1C level of >6.5% be used to diagnose diabetes, (for patients who are not pregnant and do not have hemoglobin abnormalities - these can change HbA1C levels significantly), and that people with A1C levels >6.0% and <6.5% be considered to have “subdiabetic hyperglycemia” because they have a significant risk of progressing to diabetes.

So Back to Health Reform and CER - The Challenges Ahead
The challenges ahead are to make sure that we continue to utilize future discoveries in a timely and intelligent way. Which finally brings us to health reform and CER. Health reform that expands insurance coverage should dramatically improve the diagnosis and treatment of people with diabetes - which should also help control other healthcare and societal costs because poorly controlled diabetes leads to many other costly problems.  However, immediate cost pressures present barriers to using the best diagnostic and therapeutic interventions.

Comparative effectiveness research is supposed to provide information about the best interventions, but as has been seen with advancements in diabetes, what is best often changes in progressive leaps based upon new discoveries.  And one of the limitations of CER, (and all research for that matter), is that it takes time to do the work and analyze the results.  Therefore, research really provides information about what was the best when the research started - which could have been several years before the results are known and disseminated.  And this time lag effect can be even longer when the research is based upon previously published studies or analyses of clinical records.

The lesson here is that while CER and similar research can provide very important and useful information, it must be put into the proper historical and clinical contexts.  What was state-of-the-art when the research protocols were developed may be 2, 3, 4 or more years out of date when the data is analyzed.  This reality needs to be considered when such information is used for coverage and reimbursement, and decisions about health delivery and financing system redesign.

I am confident that most insurers are not paying for A1C tests to screen people for diabetes - and that it will likely take a year or more for even the most progressive insurers to do so…. but they eventually will.  Which raises the question, what did they gain by waiting?  And what did they, (and the patients), lose?

Addendum: The hospital lab my doctor uses charges $59 for a HbA1C test.  So assuming that price doesn’t come down if more people are getting the test, the calculation needs to be made as to what is the ROI for using HbA1C as a screening test?  And the CER questions are how to identify people who would most likely benefit from HbA1C screening, and how to determine how frequently the screening should be done?

Posted in Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Health System Reform, Information & Communications, Quality of Care & Safety | No Comments »

Savings from Comparative Effectiveness Research

By Michael D. Miller MD
May 28th, 2009

The May 23rd issue of National Journal has two very interesting pieces about Comparative Effectiveness Research.

Scoring Savings from CER:
The first is in an interview with CBO Director Doug Elmendorf which includes this Q&A about scoring savings from CER:
“NJ: In the first five years after studying comparative effectiveness, are the savings that CBO can find relatively small?
Elmendorf: The estimates that we’ve done in the past suggest that by the 10th year, you are saving about as much as the cost of the research itself.  By the fifth year, you are not.  We would expect there to be savings in the private sector.  The federal government captures only a piece of that through the tax effect.  What I haven’t told you about is the net effect of comparative effectiveness research on national health expenditures.  That will tend to be a net saver for the country sooner.”

CER in Health Reform:
The next article in the NJ issue, (“The Risk of Comparing Treatments”), is about the possible inclusion of a new agency or independent institute to conduct or oversee CER. The legislative fate of such organization may hinge upon how CBO scores increased or continued funding for CER, and as seen above, it seem unlikely that CBO will attribute large savings to CER.

While scored savings from CER may be small, the fight about how CER should be used is getting hot.  The NJ article also discusses two new organizations that sound somewhat similar, but are actually on opposite sides of this issue: The Partnership to Improve Patient Care, and the Alliance for Better Health Care.  The former includes innovative companies and groups from industries such as biotech, pharmaceuticals and medical devices. While the latter includes health insurance plans, physicians and others.

Interestingly, patient organizations are divided between the two, with more disease specific groups who place a high value on the discovery of new treatments are aligning with PIPC, while broader “consumer” organizations that prioritize better information about existing therapies have signed on with ABHC.  Similarly, biomedical researchers could be viewed as split about CER, with academic researchers viewing the $1.1Billion in new CER money in the stimulus bill as a great opportunity for more funding, while industry researchers understand that the use of CER to make reimbursement and coverage decisions could reduce the incentives for investors to fund innovative private sector R&D.

So stay tuned.  The next event in the CER skirmishes will likely be around what the Finance Committee includes in their legislation about a new agency or institute for CER in the bill they are expected to unveil in a week or two.  Look for this issue, and other aspects of CER, to fuel one of the more interesting controversies within the health reform debate this summer.

Posted in Comparative Effectiveness, Economics & Financing, Health System Reform, Information & Communications | No Comments »

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