Category Archives: Access to Healthcare

Issues and analysis related to health care access

Groups Seeking Funds in Health Reform

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With all the anticipation about health reform happening soon, many groups are expecting increased Federal funding for different things, e.g. electronic medical records, expansion of SCHIP and Medicaid (or at least great funding assistance to States), more emphasis on personalized medicine, more resources for FDA to help them with their expanding domestic and international responsibilities, closing the donut hole in the Medicare outpatient prescription drug benefit, fixing Medicare’s physician payment formula, etc.

Another area looking for increased emphasis and funding – both as part of health reform and economic/jobs stimulus – are biomedical researchers.  The Boston Globe and Mass High Tech had articles last week describing how the Massachusetts Life Sciences Collaborative is lobbying for more NIH grant money.  The reason for this being particularly important for Massachusetts is the state’s leadership in receiving NIH funding, receiving NIH funding of $344 per resident in 2007.  The Boston Globe’s on-line article contains these numbers, but the print edition also had a great graphic – the data from which is in the chart below:

NIH State Funding 2007 Source: Boston Globe/National Institutes of Health.  “Note: Data is preliminary and excludes some research contracts.”

NIH supporters were successful in doubling the NIH budget over 5 years, (from ~$13B to ~$27B from FY1998-2003), and this resulted in a significant increase in the number of researcher grants and the likelihood of grants proposals being funded. However, since then, the increases have not been as significant – See chart below:

NIH Funding 1993-2008
Source: National Institutes of Health (Years are Federal Fiscal Years)

The challenge of the new Congress and Administration will be to allocate dollars for both the stimulus package and health reform to have the greatest effect in the shortest amount of time.  Fortunately, the last Congress deferred many funding decisions e.g., the SCHIP program authorization expires in March, and the Continuing Appropriations law (PL 110-329) funds large parts of the government – including the NIH – until March 6, 2009.  Therefore, this Congress will need to – and have the “opportunity” – to address many funding issues sooner rather than later.

Health Reform – Achieving Universal Coverage

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During the holidays the Obama Health Transition Team urged people to organize discussions about health care in their homes and communities – and then to report back. Reading about these discussions – including the one that Secretary Designee Tom Daschle attended in Indiana – made me think about what things are going to be needed to make health reform actually work.

My end-of-year reflections and ruminations led me to conclude that one of the most challenging parts of health reform will be to actually get more people enrolled in whatever expanded coverage plans are developed and implemented.  Enrollment barriers are not new, but they are frequently not highlighted because they may present great political and fiscal risks.

Eligible But Not Enrolled
Medicaid experts have long known that a significant number of people who are eligible for Medicaid but are not enrolled. According to a 2006 Report from the Commonwealth Fund, 62% of “uninsured children and two-thirds of uninsured, poor parents qualify for publicly funded health coverage programs but are not enrolled.”  And enrollment barriers have been seen in Massachusetts as it has implemented its health insurance coverage expansion program.  For example, Bill Walczak, the CEO of the Codman Square Health Center in Roxbury, (a low-income section of Boston), has stated that they have 1400 patients who are eligible for free health insurance, but they can’t get them enrolled because of paperwork barriers.

For several years, Washington DC has also had a health insurance expansion program called the Health Alliance.  Unlike the Massachusetts program, there are no mandates or penalties for not enrolling.  But, Bread for the City, which runs two free clinics in DC, has seen the same enrollment problems as Codman in Boston.  Both Codman and Bread have staff dedicated to helping people collect and submit all the necessary paperwork, but they still have significant enrollment barriers because of clients moving, not following up on mail, chaotic lives and trouble finding the right proofs.  I also suspect that literacy may be a problem for some people – since how can people respond to mail or find the right documents if they cannot read them?

Cost of Enrollment Barriers
Although the uninsured clients at Codman and Bread receive care when they show up, not having insurance makes it much more difficult for them to get needed medicines and specialty care.  And of course, not having health insurance hurts people in the form of poorer health.  This situation also hurts the clinics financially since they would be getting paid for this care if the patients were insured.  Codman’s CEO wrote that if their 1400 uninsured patients had insurance, they would receive an additional $250,000 per year – An amount that would make a significant difference in their ability to provide care to patients.  They face the quandary of whether or not to hire more people to help clients apply for free insurance, since this only makes sense if it brings in more money than it costs to hire someone.

In Massachusetts, Codman is not the only healthcare organization suffering financially from this problem.  The Cambridge Health Alliance recently noted that they may have to scale back services or close one of their hospitals because of shortfalls they are seeing under the new health program – some of which is due to their not getting paid for care they provide to patients eligible for insurance.

Uninsured in Massachusetts
The paperwork barriers to enrollment in Medicaid, (and other free or very low cost insurance programs), also raises questions about the number of uninsured in Massachusetts.  The number of people without insurance has certainly declined, with the latest report indicating that 2.6% of people don’t have insurance – a very significant decline from 7.4% in 2004 before the State’s new program began.

However, I’m curious about how well the surveys that generate these numbers are actually capturing the lack of insurance in vulnerable low-income populations – both because of the paperwork barriers and their higher rate of churning – even though the report indicates that rate of uninsurance for people below 300% of the Federal Poverty Level is more than 5% [See Chart below, and also see page 9 of Kaiser Family Foundation’s Medicaid Primer for discussion of the effects of “churning” on Medicaid enrollment.]

Uninsured in Massachusetts in 2008 Source: “Health Insurance Coverage in Massachusetts: Estimates from the 2008 Massachusetts Health Insurance Survey,” December 18, 2008

Solutions and Challenges
Certainly one solution would be easy and automatic enrollment.  Basically, this could be as simple as the patient signing a form stating that they meet the eligibility requirements for the health insurance program.  [Click here to see the Massachusetts Medicaid application]

The problem with a simple form is that it could lead to fraud – either by people who are not eligible so they can get free health insurance, or clinicians enrolling people so that they can just get bill Medicaid for services they aren’t providing.  One possible solution to this fraud problem would be to require that the form be signed by both the patient (or their guardian) and the clinician (or someone in their office that they designate), BUT only clinicians that the State has pre-authorized could sign and submit the auto-enrollment forms.  That way the State could limit the authorization to clinicians who already are providing care to large numbers of Medicaid patients, and thus reduce the number of organizations it would need to examine for fraud.  And of course these clinicians would be responsible for attesting that these patients are believed to be eligible for the Medicaid program.

Such a system could work by having the enrollment counselor at an authorized clinic go over the eligibility criteria with the patient, and if they meet the requirements, then together they would fill out a one page form.  Such a form could have the patient sign a single line which reads something like: “I believe my income is below the level required to be in the Medicaid program, as it has been explained to me by _________________ [Name of person signing below].”

And the person assisting them from the clinic would sign below stating, “I attest that, to the best of my ability and in good faith, I believe that __________________ [Name of person filling out top part of form] meets the requirements to be eligible for Medicaid.  I also understand that signing this form without having discussed the actual requirements with this person or reviewing any documents they have provided or are otherwise available to me which may indicate whether or not they meet the eligibility requirements, constitutes fraud and may subject me and _________________ [Name of organization] to financial and  criminal penalties – including imprisonment.  In addition, if the person signing the top of this form is found to be fraudulently enrolled in Medicaid, they could also be subject to financial and criminal penalties.  Thank you for assisting with this process.  Your contribution to improving our healthcare system is greatly appreciated. Have a great day!”

I’m sure there are problems with such a simple form, and that other people could improve on that language.  And I invite comments, edits and criticisms to this suggestion because unless we figure out how to actually enroll eligible people in free health insurance programs, then universal coverage will remain a vision outside our grasp. [Also see the Commonwealth Fund Report on how auto-enrollment might work and what Federal policies would facilitate auto-enrollment.]

Closing Observation
Anticipating that someone will suggest that other countries – like England – have figured out how to do universal enrollment and don’t seem to have the fraud I’m concerned about, I would like to note that a major operational difference between our system and England’s National Health Service is that the NHS employs the physicians and owns the hospitals, whereas Medicaid reimburses for specific clinical services.  What this means in terms of financial fraud, is that the NHS has a fixed amount of money to spend each year, (like the Veterans Health System here in the US), and if they run short of money at the end of the year they have to cut back on the care they provide.  Conversely, Medicaid just keeps paying the bills.  So in England, if people are fraudulently enrolled in their system, they are just “stealing” resources from others in the form of preventing or delaying other people from getting the care they need.  Conversely, Medicaid fraud results in Medicaid spending more money, but access to care for those who are legitimately enrolled isn’t significantly compromised because Medicaid doesn’t “run out of money” the way the NHS or the VA can.

Health Reform – How Much Expansion?

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Morton Kondracke, a columnist for Roll Call newspaper, (sorry on-line subscription required to read the full article), had a very interesting and insightful piece yesterday where he outlines some of the reasons that health reform in 2009 will be more expansive than in might have been a few years ago.

He makes two very concrete and connected observations.  First, that the economic downturn will increase the number of people without health insurance by 5-6 million, and probably add a similar number to the rolls for Medicaid and SCHIP – which will add to States’ budgetary problems.  And second, that the costs of health reform are likely to be much greater than expected – assuming of course that there isn’t a dramatic economic rebound.  The number he puts forward is “more than $3 trillion” over 10 years.

Higher costs are largely due to a greater number of people without health insurance, which would be consistent with the experience in Massachusetts:  In Massachusetts the initial estimates of the number of uninsured were too low, and more people than projected enrolled in subsidized plans resulting in higher than expected costs.  More people having health insurance is a good result from the perspective of moving towards universal coverage, (and for all the benefits it provides to individuals and society), but it is a bad result from the budgetary perspective.

How these expanding challenges are met in what is actually agreed to for health reform in the coming months, (for the legislation), and years, (for the regulation and implementation), will be important for both our individual and national health and finances.  While it would be nice to say that it is important that health reform be done “right,” because so much of what will be done is new – either in substance or scope – that I think it is more realistic to hope that the specifics of health reform don’t include too many missteps or components that need to be significantly revised in the future to correct unexpected outcomes.

What do you think?

Personalized Medicine – Fulfilling the Promise of Genetic Research

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It has been 55 years since the discovery of the structure of DNA, and 40 years since James Watson published his account of that discovery in his book, “The Double Helix.”  (A picture of my autographed copy is below.)

Double Helix - James Watson - Signed Copy

Ever since DNA was discovered to code for the structure of most living things, there has been the hope that understanding abnormal genetics would lead to the ability to treat or cure a vast array of illnesses.  Unfortunately, that progress hasn’t been as rapid as originally hoped.  But medical science is now beginning to put genomic research discoveries into actual medical practice, and start customizing medical treatments based upon each individual patient’s genetic makeup – the fundamental concept of “Personalized Medicine.”

What are genetic tests and how are they used?
The simplest genomic tests are those that inform a clinician about the choice and/or dosage for a medicine to treat an individual patient.  This type of test is generally easy for clinicians understand and use since it provides information that it is very similar to antibiotic resistance testing – a test that clinicians have used for decades.  Currently, this type of genetic testing to guide pharmaceutical treatments is being used to guide chemotherapy for cancer – where the genomic make-up of the cancer cells can indicate susceptibility or resistance to certain medicines.  It is also being used in a few other ways, including identifying individuals whose genetic make-up indicates that they should receive lower (or sometimes higher) dosages of certain medicines.

New Reports on Personalized Medicine
Several publications and reports have come out recently about advances in Personalized Medicine.  The most recent of these was three articles in the November/December issue of Health Affairs.  These articles point out the challenges for turning scientific advances into better clinical and economic outcomes.  In discussing this very broad issue these articles emphasize the progression from the laboratory, to clinical research tools, to clinically useful tests that can provide information to guide medical care, to actual treatments designed to interact with or alter the individual’s genetic makeup.

There are obviously many additional facets and nuances to this progression, and it is a very challenging road on which reimbursement plays a very important part in determining speed of development and research priorities.  That is, reimbursement amounts and policies not only influence access to genetically-based tests and treatments, but they also create incentives that guide the development of future tests and treatments.

Another recent publication is from FasterCures, titled “Patients’ and Consumers’ Interests and Perspectives in Personalized Healthcare.”  This paper provides patient perspectives – which are not overtly addressed in the Health Affairs articles.   To present a broad picture of patients’ perspectives, FasterCures surveyed various groups and individuals, and they found that:

  • Patients are just beginning to understand the concept and potential of “personalized medicine” – although the term may not be recognized or fully understood by many people.
  • Many see personalized healthcare as an advancement that should be consistent with and support “patient-focused care,” and that it should help improve the quality and cost-effectiveness of healthcare.  However, many also recognized that new tests and treatments have the potential for increasing total healthcare costs – at least in the short-term.
  • Patients want to be educated and involved, not only in their direct clinical decisions, but also in the research and development process that relates to their particular health concerns.  And there was also a recognition of the tension between genetic testing being available, and the results of those tests being meaningful and useful.  (This tension was also discussed in the Health Affairs papers.)
  • And of course, patients are concerned about the privacy of their genetic information.

The FasterCures paper concludes with a 4 point Action Plan for speeding the process of making personalized healthcare a reality:

  1. Involve Patients in Medical Research
  2. Transform the Drug Development Process
  3. Protect Patient Privacy
  4. Focus on and Deliver Patient-Centered Care

Growing Interest and Meeting Information Demands
Interest in applying genomic research to clinical medicine is clearly growing, and genetic tests and treatments will increasingly become standards of care.  For this to happen, clinicians, patients, and other key stakeholders will need a greater understanding of these tests and treatments, and their proper role in clinical care:

Clinicians will need to keep up-to-date about the latest clinical applications involving genetic tests and treatments so they can educate patients in their role as “learned intermediaries” – the term sometimes used to describe how clinicians explain to patients what is causing their medical problems and what are the best treatment options.

Patients will need to be educated about the value and meaning of possible genetically based tests and treatments. And while physicians can do some of this educating, they have limited time.  This gap has begun to be filled by Genetics Educators – a masters level clinician who can work with patients to help them understand the implications of the results of any genetic tests or family history. While there is currently a shortage of Genetics Educators, in the future they may fill a role much like nutritionists do for diabetics, but for a wide range of genetically based tests, treatments and conditions.

And lastly, recognizing that there is a rapidly expanding need to educate other key stakeholders about genomic issues, the Personalized Medicine Coalition (PMC) was formed just over 4 years ago to “to foster understanding and adoption of personalized medicine for the benefit of patients.”  The PMC was started by a couple of dozen biotechnology, pharmaceutical and information technology companies and groups, but has grown into a much larger coalition that includes academic institutions, government agencies, patient advocacy groups, payers, clinical testing companies, and others.  Collaboration among these types of groups that will be necessary for developing, validating, determining appropriate uses and reimbursements for genetically based tests and treatments so that Personalized Medicine will become part of the solution for increasing the quality and cost-effectiveness of healthcare.

Medical Homes, Hammers and Nails

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Medical homes are being promoted as a way to improve health care delivery by increasing the coordination of patient’s primary and specialty medical care.  The goal of medical homes is to ensure that patients’ care is comprehensive, appropriate and patient-focused.

One of the benefits to the patients and the healthcare system is that medical homes can help sort out the confusion that can arise from the phenomenon sometimes described as, “When you’re a hammer, everything looks like a nail.”

Hammer & Nails

In healthcare delivery what this means is that sometimes the diagnoses or treatment recommendations from specialized clinicians will reflect their expertise – and thus their may be inconsistencies or conflicts in the recommendations coming from several  specialists. The challenge for the patient is to determine the best course of action for them.  And that’s where the value of their primary care clinician in a medical home – they have access to all the patient’s information and can help coordinate and translate all this information for the patient, so together they can make the most informed and appropriate decision.

This coordinating and translating task is important for acute and serious illnesses, as well as for chronic conditions – particularly when their is no generally agreed upon standard of care, of if the accepted course of treatment does not prove satisfactory for the patient.

This situation arose recently for a friend at the same time there was an article in the New York Times where the author described her nearly identical series of interactions (and frustrations) with the medical care system when dealing with hallux limitus or rigiditus – basically, limited motion of the big toe, accompanied by pain caused by bone spurs and/or arthritis.  The “hammer sees a nail” phenomenon here is that the surgeon sees primarily a problem that can be solved with surgery, while the podiatrist sees primarily a problem that can be helped by an orthotic.  As the New York Times author discovered, there may be other options that could work for her.  But from her writing – and my friend’s experience – this was discovered because of the patient’s diligence and not from the coordinating role of her primary care clinician in a medical home.

Another way to view the function of the medical home is to look at a medical home as trying to replicate the close interpersonal relationship between each patient and their primary care clinician that existed decades ago, while still enabling the patient to take full advantage of medical advances.  In addition, such relationship building could help reduce malpractice costs since it should improve both the quality of care, and patient-clinician communications about the goals and expectations from possible treatment options.

Challenges to Creating Medical Homes
Building these homes faces several challenges, including the shortage of primary care clinicians who need to be at the center of the coordination process working with patients and other clinicians to define realistic and patient-specific goals and treatment plans. Another challenge to creating well-run medical homes is that specialists may balk at being part of such a formal coordination process.

Implications for Health Care Reform
What this mean for health care reform is that while medical homes should be promoted, they cannot easily be created for everyone from our existing resources.  Therefore, they should first be built where they can have the greatest impact – for people with chronic and multiple medical problems, while at the same time our overall capacity of primary care clinicians is increased.  These two initiatives can be complementary because creating successful medical homes should increase the economic attraction of primary care as a medical career, while also demonstrating to medical students and residents the value and attractiveness of primary care when practiced in a medical home type setting.

In addition, other important health reform initiatives such as electronic medical records, and turning the findings from comparative effectiveness research into actual medical practice, will support of the creation of medical homes that can improve the quality of medical care, help reduce waste and improve the overall efficiency of health care delivery.

And lastly, it is clear that there is a desire for medical home type services since this is basically the concept underlying concierge medical practices.  For those not familiar with concierge medicine, this is where the primary care clinician signs up a limited number of patients who pay $1,500 – $25,000 per year, and the clinicians commits to spending more time with them, will explain in greater detail their medical issues and options, and take on the role of coordinating their care amongst all needed specialists.  While I don’t have the data, I’m guessing that individuals who are are paying for these concierge services are not the patients who would receive the most clinical benefit from medical homes.  And clearly, with too few primary care clinicians, having these physicians limiting the number of patients they will see doesn’t alleviate that shortage.  So, while I understand the motivations and market forces driving the creation of concierge medical practices, given the current problems in our healthcare system, I don’t think they are pushing the use of limited resources in the best direction to benefit society overall.

Communicating Health Information and this Blog’s Goals

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Noting that I’ve written about a wide variety of health and biomedical research issues, someone recently asked me about the focus of this blog.  My response was that my goals are two-fold:  First, to present synthesized information – created by combining different sources and analyses – in ways that provide new perspectives on important issues so that people have both broader and deeper understanding of these issue.  And second, to reach multiple audiences with this information and perspectives so that the spectrum of healthcare stakeholders can better communicate and understand each other.  Which is just stating in a different way what I wrote in my first posting, that the reason I started this blog was “to provide stakeholders of all types, (such as patients, clinicians, administrators, payers, researchers, regulators, legislators, etc.) a forum for discussing healthcare policy issues. The focus of these discussions will be about how the development and use of innovations can effect clinical and economic outcomes.”

I view these two goals are complimentary, since together they help people crystallize insights about issues and make them more able to consider what specific actions would be most productive.

Sometimes my analyses take the form of questioning how information is presented to different stakeholder groups, and how that could be done more effectively.  For example, in the last two days I saw that the FDA notified a company about selling two unapproved over-the-counter medicines (asprin plus nutritional supplements), and issued a warning about a banned ingredient in a food product (Mexican “vanilla”). The challenge for the average person is to first hear about this information, so they can be aware of any risks, and second, to put it into a context useful for them -  such as the potential problem with “Mexican vanilla” if they are taking blood thinning medicines.

For both these situations the FDA issued a press release and notices intended for consumers.  Newspapers generally pick up these stories, and print them in ways that appropriate for the scope of the issue – usually a few inches on an inside page.  My concern is that some people who should know this informaiton might not be made aware of it because the FDA’s very broad mandate and limited resources means that different outside advocacy groups and the media need to spread the word.  Certainly better internet communications and increased FDA funding should help improve this, but as I’ve said before, I think there needs to be broader evaluations of how people get their health informaiton and what they do with it.

We clearly have a health information gap this country – and if this gap was in medical technology or military capabilities then the general public, the media, and politicians would be more engaged and upset.  Thus, the challenge for our country is to expand our discussion of the development and delivery of useful, (some would say actionable – but I don’t like that word), information to people so they can change the decisions they make that affects their health and wellness.

Another example of communications challenges involved the start of Medicare’s new system for paying physicians in the early 1990s.  While the methodology was very complicated – and is still somewhat contentious – the communications issue that rankled many physicians was how the new system was described as distinguishing between what were called “cognitive” and “non-cognitive” services. What this really came down to was differentiating between health care delivery involving a procedure, (like an operation), and testing, talking and prescribing.  As you might imagine, surgeons were not too pleased to be told that what they did was “non-cognitive.”  The reason I raise this old example, is that one of the major challenges facing the US healthcare system is the shortage of primary care clinicians.  And I can imagine that there will be some communications challenges with both patients and clinicians about how to improve this situaiton in the future.  While any policy changes might not pit surgeons v. non-surgeons, it very well might find specialists and primary care clinicians at odds over terminology, status, and of course….. money.

So those have been my goals for this blog, and a couple of examples of the challenges of communicating health related information to different stakeholder groups.  I hope that my postings have at least partly fufilled my goals, and from the comments left here, the emails I’ve received, and direct feedback from readers, I think there’s been some success.  I will continue working to build on those successes, and if you have any comments or suggestions, please let me know – either as a comment here, or via email.

Direct to Consumer Advertising: Drugs, Hospitals, Research….

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A very contentious health policy issue is that of advertising.  Usually the specific topic is the advertising of medicines directly to patients – known as “Direct to Consumer Advertising.”  There have been proposals to limit or ban this activity, and some states have, (or have proposed), limiting or requiring disclosure of other marketing activities by pharmaceutical companies – such as marketing directly to doctors and hospitals.

However, I’ve found it intriguing that many other components of the healthcare industry advertise directly to patients.  For example, the Boston area free daily paper, Metro, contains lots of ads recruiting people to participate in medical research trials.  There are also many ads in the newspapers and on the radio about local hospitals – generally touting their expertise in one area or another that is lucrative for the hospital, such as joint replacement surgery.  And unlike pharma products, these other types of advertising aren’t regulated by the FDA – although they may be overseen by other Federal or State agencies.

Another very large vat of health related advertising is done by the herbal and nutritional supplement industry. This is a huge area of medical related advertising.  It is overseen by the FDA and FTC, but I have an entire talk about how this type of advertising fits in with the other information patients receive about their illnesses.  So I’m not going to expand upon this area here – perhaps in another blog posting.

And of course physician advertising was generally seen as unethical until about 10-20 years ago. But now, while still uncommon, (I’m not counting web-sites for physicians offices that tell people the address and phone number, and describe the clinical service the practice offers), it is not unknown for physician practices to advertise.  (Some physician related advertising is also probably partly incorporated into that done by hospitals and others.)

Issue Advertising
Another form of advertising that is quite prolific is issue advertising directed toward policy makers.  Although health care can’t seem to break out of 3rd place in the public opinion polls about the Presidential election, the healtcare industry is still paying about $10,000 per page for advertising in publications like National Journal.  And while the pharmaceutical industry certainly accounts for a portion of these ads, many other groups with healthcare interests are doing this too.  For example, flipping through some recent issues of National Journal I found ads from the following organizations (in alphabetical order) with these headers:

  • American Academy of Family Physicians – “If you health care isn’t working, neither are your employees”
  • American Health Care Association – “Home is not just where you live.  It is where people care for you”
  • American Vetinary Medical Association – “Isn’t a child’s health worth more than a penny?”
  • AstraZeneca – “What does AstraZeneca stand for? Patients”
  • BlueCross BlueShield Association- “When you cover one in three Americans you don’t just offer coverage, you offer solutions”
  • National Association of Realtors – “Soaring Health Care Costs Have America’s Small Businesses on Life Support”
  • Novartis – “People say driving a truck is dangerous.  What about high blood pressure?”
  • Office of National Drug Control Policy – “Rebuild After Meth”
  • Pfizer – “Working together to improve the health of individuals, and the health coverage of the nation”
  • Pfizer helpuful answers - “Prescription assistance for uninsured Americans, from sea to shinging sea”
  • Science Applications International Corporation – “He tells cancer cells to starve themselves to death”
  • SEIU & Greater NY Hospital Association – “Our Nation’s Teaching Hospitals”

Conclusions
I wish I had a simple set of solutions for what troubles people about about both issue advertising and healthcare organizations advertising directly to consumers.  My one overarching conclusion is that assessing the impact of paid advertising directed at patients and policy makers needs to be done in the context of what other information they are being bombarded with from healthcare professionals, the media, family, friends, academic and policy researchers, and others.  Examining the influence of one area of information without evaluating what other types of information may be effecting patients’ and policy makers’ attitudes and actions is like blaming the ocean for hurricane Katrina’s  devastating flooding – I’m not a meteorologist, but I think the wind and atmospheric pressure had something to do with it too.

Pfizer Exiting Heart Disease Research – What about Heart Failure?

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It was reported yesterday that Pfizer will stop doing research and development in heart disease, anemia and osteoporosis to concentrate in other areas such as cancer, diabetes, and immunology/inflammatory diseases.

This is interesting since Pfizer has (and had) a large number of products in heart disease, including Lipitor, and pharmaceutical companies have typically continued to do research in areas where they have had products because they have established sales people who are knowledgeable about the disease area and have relationships with clinicians in those areas.  The countervailing force is that many effective medicines to treat heart conditions (like high blood pressure and high cholesterol) are available in generic forms and thus the value bar (benefit/cost ratio) that new medicines must reach to be competitive is much higher than when they competing against other non-generic medicines.

However, one common and very expensive heart condition where better medical treatments are needed is heart failure – often called congestive heart failure (CHF).  According the the National Heart Lung and Blood Institute, 5 million Americans have heart failure, and 300,000 die from it each year.  The costs for these patients are very significant: Total costs for treating heart failure in the US are estimated to be $34.8 billion in 2008, and Medicare spent $4.7 billion for hospitalizations related to CHF in 2006.

The chart below from the Centers for Disease Control and Prevention shows the rate of hospitalization (per 1000 people) for heart failure in the US by age group over the years 1979-2004 – clearly a growing problem.

 Hospitalization Rate (per 1000 people) by Age Group for Heart Failure
1979-2004

CHF Hospitalization Rates

So what does this mean for better treatments for CHF? According to the pharmaceutical industry’s web site database, there are currently 35 therapies in clinical trials for heart failure or congestive heart failure – including 3 based upon stem cell therapies, 1 based upon cell transplantation, and 1 using gene therapy.  (This compares to the 105 therapies in development for cancer, and 81 for pain.)  So I guess there will continue to be new treatments developed for heart failure, just probably not by Pfizer.  But, recognizing that there are lots of medical problems and limited resources need to be prioritized, will this be OK for current and future patients with heart failure?

Companies allocate and prioritize research and development resources according to three fundamental factors:

  1. Unmet Medical Need
  2. Scientific Opportunities and Discoveries
  3. Market Potential

It is this last one that apparently Pfizer has decided has decreased, so they will be putting their resources into other areas where the combination of all three factors looks more appealing.  As long as all the research-based biopharma companies don’t make those decisions in the same direction (i.e. into and out of the same diseases), then research resources will likely be allocated in a reasonable way to meet societal needs. In that way the needs of people with heart failure will be balanced against those with cancer, chronic pain, diabetes, neurological diseases and immune dysfunctions – which is what society and patients really should want, since people often have multiple diseases or medical problems, so they should want new and better treatments for all of them.

Addendum: The memo from Pfizer’s R&D leadership about their strategic realignment has been posted by Forbes – click here.

3 Months Late – Massachusetts Waiver Extended

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Just a quick FYI – Today’s Boston Globe reports that the Federal Government has approved a new 3 year Medicaid demonstration waiver for Massachusetts – with $10.6 billion to enable the continuation and growth of the state’s health insurance coverage expansion program.  The original 3 year waiver expired at the end of June, and the state and Federal officials had been discussing a new 3 year waiver for many months before that deadline.  Since the end of June, the state’s program has been running on a series of several week extensions to the old waiver granted by the Federal Government.

More on Employer-Based Health Benefits

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A couple of weeks ago in writing about ERISA, I included some data on the stability of health benefits provided by large companies.  The Kaiser Family Foundation just released their 2008 Employer Health Benefits Survey.  Below is the updated chart from my earlier post.

Large Companies (>199 employees) Offering Health Benefits:
Eligibility, Take-Up and Coverage Rates

KFF Annual Survey 1999-2008

The Kaiser Family Foundation’s Report also included an interesting table that provides some insight into what I wrote earlier this week about the differences in employer health benefits between high and low turn-over industries.  The relevant information from  the Kaiser report’s Exhibit 2.3 is below:

Percentage of Firms Offering Health Benefits by Industry in 2008
Agriculture/Mining/Construction                                                67%
Manufacturing                                                                           73%
Transportation/Communications/Utilities                                    89%*
Wholesale                                                                                74%
Retail                                                                                        40%*
Finance                                                                                    81%*
Service                                                                                     58%
State/Local Government                                                           97%*
Health Care                                                                              71%
ALL FIRMS                                                                          63%

[* Estimate is statistically different (p<.05) from all other firms not in the industry category.]

Given the findings of the research discussed in my other post, these industry differences shouldn’t be surprising.  However, I do wonder if after this week the Finance Industry will still be on the high end of providing health benefits.  Of course, it also raises the question of whether financial firms that survive through a federal “bailout” or “takeover” (whatever the end result is) will offer health benefits 97% of the time like state and local governments?  If so, then the number of employees that have access to health benefits may increase – although I also suspect that the number of employees in that industry may decline overall, and possibly add to the number of people without health insurance.

In any case, I’m confident that the issue of employees’ health benefits will not be a significant concern for those trying to work out stabilizing solutions for the upheaval in the financial industry.  This would be consistent with the priorities that led to the famous statement about the 1992 Presidential campaign, “It’s the economy stupid.”  Or was it, “It’s the stupid economy”?