Why are medical care guidelines kept behind journal paywalls?

Think you and your doctor can access the latest expert knowledge about your medical condition?  Think again.

Imagine you have cancer and receive chemotherapy. You develop a complication–a life-threatening blood clot, the second leading cause of death in cancer patients after the cancer itself. You’re frightened. What should your doctor do to save your life? Are there drugs available? If so, which one is best? At what dose? For how long? Will it interfere with your chemotherapy? How will you prevent a future clot? Where will you and your doctor look to find the answers to guide your treatment decisions?

You are in luck. You and your doctor don’t have to begin from scratch. In fact, an international team of experts in your very condition have reviewed all the research literature. Research which was likely tax-payer funded. Research which recruited patients like you to be volunteers in the clinical trials. At great time, effort and expense, this expert group met and debated about what is best to do in your very situation.

And extra lucky for you, this expert group after they reached a consensus wrote up their recommendations in a concise document and published it online in a major medical journal just so patients like you could one day benefit from their work—exactly what you and your doctor need to inform the next steps of your treatment

Sadly, this is where your luck runs out. Despite this wonderful life-saving document being published by a major, reputable medical journal, neither you nor your doctor has permission to read it. It is behind a website paywall and you lack access.

Welcome to the world of medical journal publishing, where a handful of corporations control public access to scientific research and evidence-based health care protocols.

Limited physician access

Institutional subscriptions are the most common way medical journals disseminate information and costs vary by customer. As example, the Annals of Internal Medicine quotes an annual access rate for a community library of $1,273 while the fee for a large hospital network is $6,207. This is merely for one journal subscription; there are hundreds of medical journals one must subscribe to for a comprehensive collection.  As journal subscriptions rise, libraries and individuals have been forced to cut back on the depth and breadth of journals purchased.

To download individual articles, fees ranging from $30–$50 for a single article are commonly charged.

It may come as a shock to those behind ivy walls, but there are still physicians in America who own their own practice, hire their own staff, pay their own bills, and must tap their own resources to keep up with the latest medical research. Nearly half of all US physicians are self-employed.

While some physicians enjoy subscriptions provided by their academic institutions many more do not. It may come as a shock to those behind ivy walls, but there are still physicians in America who own their own practice, hire their own staff, pay their own bills, and must tap their own resources to keep up with the latest medical research. Nearly half of all physicians are self-employed and not part of a hospital or academic teaching institution, according to the American Medical Association.

These physicians do not have the benefit of enjoying the deeper pockets of a large academic institution where journals are a comparatively smaller budget line-item.

No patient access

Price for 24 hours of online access

Patients engagement is the current buzz word in health care. We patients like to be informed and proactive in our care. We call upon Dr. Google without hesitation. Medical journals are the most reliable, scientifically-sound, evidence-based source of medical information available on the internet. Yet patients cannot access them.

Publishers say they support patient access, but fail to provide a clear pathway for it.

When queried, editors of major medical journals indicated to me they will send any article to a patient upon request. Yet, they fail to mention this at all on their website nor provide instruction as to whom or how a patient can request an article. The only option offered to patients is the ‘Pay-per-view’ option, which allows only 24 hours of access to view 1 article. See the fee chart above for a sampling of fees requested of patients.

For optimal health outcomes, it takes and informed patient partnering with an informed health care provider.  yet, patients are unable to access evidence-based medical information and scientific research results online.  Without access to quality publications, patients cannot contribute to informed decision making.

Record publisher profits

Medical journals are a for-profit publishing business. Yet, the product they provide often falls within the realm of public good. Can they afford to give more of their product away? Let’s go back to my initial example of the cancer patient and physician needing information about treating a blood clot complication. Where would one go to learn the answer?  And, could the publisher of that answer afford to provide free access to the information?

Lancet Oncology, published by Elsevier, recently published online a guideline titled 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer.  This guideline was written by an independent academic working group aimed at establishing a global consensus for the treatment and prevention of blood clots in patients with cancer. These blood clots, known as venous thromboembolism (VTE) are the second leading cause of death in patients with cancer, after the cancer itself. Ninety-nine clinicians are named among this guideline’s authors and it 16-pages cover every imaginable cancer and clotting situation; so it’s a comprehensive and highly reputable—a gold standard guideline.  This guideline will answer our example patient and physician questions.

Yet, this guideline sits behind a paywall. A patient or physician trying to read the guideline will be prompted to either subscribe to the journal–at $195.00 for online-only–or pay $31.50 for 24 hours of online access of this one article.

Why? It clearly is not because the publisher Elsevier needs the additional cash flow. Last year, Elsevier charged its customers enough to yield a 37.1% profit–a margin higher than that of Apple, Google or Amazon. (Apple= 21.5%, Google= 21%, Amazon= 4.8%)

Medical journal publisher’s profit margin = higher than that of Apple, Google or Amazon

What does the journal say about access?

Since I could not read the guideline and knowing that fifty-five percent of cancer patients receive their care from a community oncology practice not affiliated with an academic institution which would provide journal access, I was compelled to ask the journal to make this and other guidelines publicly available. I emailed the Editor-in-chief and Publishing-Director of The Lancet Oncology, Dr. David Collingridge, asking him to drop the paywall for the above referenced guideline, as well as all guidelines. He declined to do so.

Elsevier is not alone with its profitable business model.  All five of the largest medical journal publishers have posted continued growth with high profit margins–Elsevier, Springer Nature, SAGE, Taylor & Francis and Wiley-Blackwell.

Further troubling is that many medical journals–such as Circulation and JAMA–are affiliated with nonprofit organizations whose very missions are to improve health care.  Yet, if a patient or physician wants to read an article, a pops up box appears requesting payment. 

Informed decision making…it’s a good thing.

Clinical care guidelines offer concise instructions on various clinical situations with a goal of improving the quality of care and improving patient outcomes. Why on earth would anyone not want all physicians and patients to have equal access to that? Yet that is exactly what is happening and for no discernible reason other than profit-motive.

It calls into question larger issues of: Who owns the results of medical research? What are the rights of patients and physicians to access the results of medical research? Is there an obligation to make public medical research which is funded by public sources..ie taxpayers? These are the issues our society has yet to full address.

Expert knowledge should not be kept hidden but widely disseminated–to both clinicians and patients. Clinical care guidelines are but one type of journal content and unique enough in nature that they should be considered a public good. Given the high profit margins of parent companies, it would seem medical journals could quite easily choose to place clinical care guidelines outside their paywalls as a public service. Publishers have a window of opportunity to do the right thing on their own before public pressure will invite government intervention.

I call upon each of the major medical journals–Elsevier, Springer Nature, SAGE, Taylor & Francis and Wiley-Blackwell–to make clinical care guidelines open access in their medical journals.  It’s a small step which can have great impact. The public deserves easy access to life-saving clinical care guidance.



Pre-existing condition: a palatable term for government sanctioned discrimination

We tend to think of health care as complicated.  Here’s a little secret:  it’s not.  It’s only evolved to be a complex system because we’ve made it that way.  When a physician sees a Medicare patient, an estimated 130,000 pages of rules and regulations influence that relationship. The Affordable Care Act and it’s supporting regulations are defined in over 20,000 pages.  Private insurance policies are as varied as the millions of firms offering employee health plans. Add to the mix that these coverage rules are in a state of constant revision.

Any interaction that is managed with volumes of legal-ease is bound to be one the ‘average American patient’ will not understand and with new health care proposals coming from Congress with little notice in rapid succession, it is next to impossible to comprehend how provisions buried in tens of thousands of pages may impact us far down the road.  It need not be this way.

At its core, our complex health system governs one very simple fact of life:  we get sick and need help to get better.   The devil in the details comes in how government chooses to manage this basic need of its populace.  It’s disheartening that the current health policy mentality doesn’t seem to appreciate this basic fact.

Humans are frail living creatures.  We don’t live forever.  We each die of something biological that causes our bodies to stop functioning. None of us will live our entire lives without having a single illness or accident.  Cut us and we bleed.  If we fall, our bones break. Our vision and hearing decline over time.  Our teeth rot.  And if we live enough years our hearts will eventually tire and fail.  Our cells easily mutate and multiply…cancer.  If you think of it, our bodies are so subject to ailments that it’s a wonder in ancient times we lived long enough to advance civilization at all!

Yet, this natural propensity towards illness is now given the ominous regulatory label of ‘pre-existing condition’, which has come to carry a negative connotation with penalize-the-patient policy proposals.  Don’t think illness is the natural order?  Health and Human Services analysis shows up to half of Americans under age 55 have a pre-existing condition and that number rises to 86 percent for those over age 55.  Fact is, most of us have already experiences some form of major illness in our lives and for those who haven’t, live long enough and your time is surely coming!

But alas, all is not lost!  Here comes science and medicine as the saviors of humanity.  Modern health care compensates for our physical frailties. Until this century, life was nasty, brutish and short. We now have the mind-blowing ability to have our vision corrected, repair our dental cavities, remove cancerous cells, mend a broken bone, treat a failing heart and stop a serious bleed.  Science and medicine extend not just our life, but improve the quality of that life.  That’s huge.

The rub is that life-extending scientific achievement comes with a price tag.  Our entire, complex health system is set up for no other reason than to sort out who in society can easily access these scientific accomplishments, when and how much they should pay for it.  That’s it. There is no other reason for private insurance, Medicare or Medicaid to exist…they are the more palatable modern version of ancient gladiatorial fights, with the winners (those who can access and afford care) being able to live another day.

The larger question is whether government’s rules for the fight should be applied equally to all persons regardless of age, gender, geography or any other criteria.  If we truly believe in equality, it must. To create layers of complex code which creates conditions in which only seniors, only the disabled, only the poor, only those without pre-existing conditions can access government facilitated care is contrary to ensuring the general Welfare as defined as an essential role in the Preamble of the US Constitution.

To create layers of complex code which creates conditions in which only seniors, only the disabled, only the poor, only those without pre-existing conditions can access government facilitated care is contrary to ensuring the general Welfare as defined as an essential role in the Preamble of the US Constitution.

There’s a fundamental inequity when government intervention results in a playing field in which a 68 year old cancer patient, retired with Medicare can access life-saving treatment, potentially, without paying a single dollar out of pocket but a 38 years old cancer patient, working full-time with employer sponsored insurance, cannot.  And, if the younger patient is lucky enough to survive, go back to work and pay off medical debt, they are penalized by not ever being able to get insurance again due to now having a ‘pre-existing condition’.  Such inequality created and endorsed by the federal Government via thousands of pages of regulation unintelligible to the ‘average American’ runs counter to its purpose of promoting the general Welfare.

If we accept as a fundamental starting place that we are all equal then why would this equality not apply to everything the government does, including insurance?  Otherwise, the federal Government is favoring one segment of people over another…the well over the sick, seniors over the middle aged and the young, the poor over the middle class, those who have lived long enough that the natural frailty of the human body has manifested in a “pre-existing condition” and those who have not.

To draw a line and say ‘this group is worthy of easily accessible and affordable medical care and this group does not’ is truly rather arbitrary.  It is not the federal Government’s role to divide us into segments, but rather to treat us all equally in its exercise of power.  If one segment deserves medical care, then we all do.  Few of us will escape this life without encountering an illness, accident or frailty. Any policy which does not reflect this undeniable fact is doomed to eventual failure.

Call it ‘Medicare for all’, call it ‘single payer’, call such a health system by any name you wish….but call our only fair option what it should be, an equal right to enjoy government’s promotion of the general Welfare.  That’s not socialism, it’s equality and that’s about as democratic as it gets.

Direct to consumer thrombophilia testing approved–a good thing?

Approved list from FDA Press Release

On April 6, 2017, the FDA  approved marketing of 23andMe Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions.(FDA Press Release 4-6-17) No prescription or physician needed. These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical conditions.  Among them, hereditary thrombophilia.

The “hereditary thrombophilia” wording used in the FDA release is a very broad term. There are multiple genetic variants which have been shown to correlate with increased clot risk including heterozygous & homozygous Factor V Leiden, prothrombin 20210 and deficiencies of antithrombin, protein C and protein S.

So a question I posed to both the FDA and the company 23andMe was 1) Which specific thrombophilias does the panel test for and 2) to what specificity—ie do results only indicate the presence of a gene mutation or does it report whether the mutation is heterozygous or homozygous.

Two most common thrombophilias included

The company replied with the following information:

“The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person’s overall risk of developing harmful blood clots. This report is most relevant for people of European descent.”

The FDA responded with identical wording and indicated more details may be in the de novo pathway Decision Summary for the product, which may not be publicly posted for some time due to the need for review by the Freedom of Information staff.

What does this mean?  23andMe’s genetic test will include the 2 most common thrombophilias–Factor V Leiden and Prothrombin 20210 mutations.

Factor V Leiden thrombophilia is the most common thrombophilia in the United States. “Between 3 and 8 percent of people with European ancestry carry one copy of the factor V Leiden mutation in each cell (heterozygous mutation), and about 1 in 5,000 people have two copies of the mutation (homozygous mutation). The mutation is less common in other populations.” (Source: NIH Genetics Home Reference, US National Library of Medicine)  The heterozygous mutation increases clot risk 5 fold, the homozygous mutation increases clot risk 18 fold. (see chart source below)

Prothrombin thrombophilia is the second most common inherited form of thrombophilia after factor V Leiden. “Approximately 1 in 50 people in the white population in the United States and Europe has prothrombin thrombophilia. This condition is less common in other ethnic groups, occurring in less than one percent of African American, Native American, or Asian populations.” (Source:  NIH Genetics Home Reference) The heterozygous form of the mutation increases clot risk 4 fold; no data was available on homozygous risk.(See source chart below)

Why testing may (or may not) be helpful.

First, to be clear, when we are talking about a genetic thrombophilia, what we’re truly talking about is not a disease but rather a specific gene mutation that results in an increased tendency to form abnormal blood clots known as deep venous thrombosis (DVT). DVTs are fairly common–impacting ~900,000 Americans annually–and occur most often in the legs, although they can also occur in other parts of the body such as the arm, brain or abdomen. DVTs which travel to the lungs result in pulmonary embolism (PE), which is a potentially life-threatening condition. In the US, pulmonary embolism deaths outnumber those from breast cancer, AIDS and car accidents combined.

Inherited thrombophilias are found in around half of all DVT/PE patients.

Inherited thrombophilias are found in around half of all DVT/PE patients.(Source) So what a thrombophilia test does is look for a gene mutation which is correlated with an increased risk for developing these types of deadly clots.  Sounds desirable, yes?  The rub is that not everyone with the genetic mutation will develop a blood clot.  In the most common thrombophilia, Factor V Leiden, only about 10 percent of individuals with the factor V Leiden mutation ever develop abnormal clots. (Source)  Blood clots are often the result of a combination of risk factors–such as hospitalization, cancer, long-duration travel, surgery, pregnancy, estrogen containing oral contraceptives in addition to thrombophilia.(Source)

With that said, there is a subpopulation of thrombophilia patients at very high risk for developing a blood clot.  These are the patients for whom access to thrombophilia testing would potentially be life-altering. The following chart (Source ) is helpful to illustrate:

Lim, Moll,Thrombophilia Vasular Medicine, 2015
Put into perspective

I have publicly disclosed previously that I have a high-risk thrombophilia–homozygous Factor V Leiden.  You will notice in the chart above, that means my risk for developing a blood clot is 18 times greater than someone without the mutation.  Indeed, the statistics bore out and I developed both DVT and PE in 2003 for which I was hospitalized 9 days and, without exaggeration, nearly died from my clot. I am now on life-long treatment to prevent a recurrence. Most folks would agree that’s something pretty bad to avoid if possible.

The question then is:  If I’d known I carried this high-risk mutation years earlier, could I have taken steps to reduce my risk and avoid the clot? Absolutely. Effective prevention strategies exist. For one, I would not have chosen to take an estrogen based oral contraceptive (which further increased my clot risk) and when I suffered from pregnancy complications, my physician and I would have better understood the potential cause and managed it better as a high risk pregnancy. (pregnancy and c-section both increase clot risk). So, in theory, if I’d known earlier I had a high-risk thrombophilia, it would have altered my lifestyle and medical decisions in such a way that, perhaps, my eventual DVT/PE episode as well as pregnancy complications could have been avoided.  There is of course no way to know for certain since for some people, despite best prevention efforts, clots and complications still happen.

Views from the medical community

For the past 2 years, I have served as a patient representative and voting member of a thrombophilia evidenced-based guideline panel of the American Society of Hematology.  And while I cannot disclose the group’s findings until publication, I can make some general observations.

The medical community is conflicted about when and why to do thrombophilia testing. There is inconsistency in daily practice from clinician to clinician and hospital to hospital as to when tests are orders, for what patients and how those are used to inform decisions. Research studies tend to be few, with small study size and therefore of limited quality.  Decisions based on such weak data translates into a diversity of opinions and practices. Thrombophilia testing as it correlates to outcomes is an area in which further clinical research is sorely needed.

What is clear, is that we are at a crossroads for thrombophilia testing and the FDA approval of a direct-to-consumer test reflects this change in thinking.  A decade ago, thrombophilia testing was considered rather routine following a DVT/PE.  More recently, the pendulum  swung to an opposite extreme to where few clinicians routinely test for thrombophilia. (See the ACCP guideline for current recommendations & evidence)

Based upon recent data, I suspect we will eventually end up somewhere in the middle of these two extremes—to where there will be a certain patient population in which thrombophilia testing is warranted and helpful in informing decisions, patients such as myself for example.   The challenge will be in how to screen and find those persons at high-risk for clotting, without over-testing and creating undue worry in those patients who are lower-risk for clotting.  It is the shared challenge of every screening test really–from breast cancer to PSA–how to maximize helping the most numbers of patients and minimize potential harms. In my view, this is where education of both patient and provider is essential.

Patient & provider education gaps

Unfortunately, patient education is an area of great concern and where we fail badly. Very badly. Ideally, every person who receives a genetic test would receive counseling before and after.  As this doesn’t always happen with diagnostic thrombophilia tests, it is unrealistic to expect it will happen with direct-to-consumer tests either.  I, myself, received no genetic counseling before or after my thrombophilia test–it was never offered. In fact I never even knew my clinician had ordered a genetic test until the results were given to me by a different provider who really, in hindsight, didn’t articulate accurately what the results meant.  My understanding of the impact of the test was very much a process of self-education and searching for a knowledgeable clinician, in my case a thrombosis-specialized hematologist.

A 2008 Surgeon General report found clinical gaps in thrombosis  knowledge and the inconsistent application of evidence based interventions.  My personal experience is that little has changed since the report’s release. While any provider in any specialty can order a thrombophilia panel, not every provider is skilled in interpreting them. Thrombophilia specialists are few. With direct-to-consumer testing, there is the potential for patients to have a difficult time finding a professional well-versed in thrombophilia and its implications for thrombosis risk management.

Why are there still gaps in thrombosis knowledge?  There is no line-item funding in the federal budget for venous blood clot education…without it and engagement of federal public health agencies, the dissemination of patient and provider education is severely hampered.  So whether a patient is able to access accurate information in interpreting a positive thrombophilia test is going to be entirely dependent upon how knowledgeable their individual provider is with interpreting such tests and his/her willingness to refer a patient with no prior thrombosis, but a positive thrombophilia home test, to a specialist for a more thorough thrombophilia evaluation and discussion.   It will also reflect the patient’s ability to pay–and insurance company’s willingness to reimburse—for such specialized consultation and additional testing in the absence of an acute clotting event.

My recommendation

To put the finding of a positive thrombophilia test into perspective,  patients need solid information and my concern is that they won’t easily get it. Yet despite this limitation, at the moment, I would recommend the 23andMe service and here’s why:

  1.  Knowledge empowers.  Everyone should know their clot risk.  I am a strong advocate that the public needs greater awareness and education of their blood clot risk.  This test will serve that goal.  Is it diagnostic?  No.  It is not meant to replace diagnostic testing. Perfect solution?  No.  But it is a start in the right direction and if it informs and empowers 1 person to take steps to reduce their clot risk such that a future clotting event is avoided…it is well worth it.
  2. Cost considerations.  A typical ‘thrombophilia panel’, consisting of 5-8 diagnostic tests, ordered by a physician costs around $3,000 in the US and would include tests for all the 5 mutations discussed above plus a few others which are considered ‘acquired’ thrombophilias.  Currently, 23andMe markets a genetic test panel of 65 genetic reports for $199 US.   That’s an incredible cost difference.  While the 23andMe is not meant to be a diagnostic test–it won’t replace the $3000 panel—it holds potential as a first line screening tool to allow for greater public screening of lower risk individuals.  Cost is one of the biggest drawbacks as to why we don’t see more public health screenings of all types of conditions, thrombophilia is no exception.
  3. Privacy and genetic discrimination.  Direct-to-consumer thrombophilia testing may provide a way for people to learn more about their thrombophilia status without it becoming part of their formal medical record. This may be most helpful to 2nd or 3rd degree relatives of those already diagnosed with thrombophilia or a DVT/PE event to where there is curiosity if they share a trait but don’t wish to, for whatever reason, undergo diagnostic thrombophilia testing.  The degree of privacy of both forms of testing is still unclear.  In the US, when a patient goes to a physician and a thrombophilia test is ordered, those results become part of the patients permanent medical record.  A positive thrombophilia test has implications far beyond clinical decisions.  The Genetic Information Nondiscrimination Act (GINA) protects individuals from discrimination based upon a genetic test result. However, it’s protections are limited.  While a person with a positive thrombophilia result cannot be denied health insurance or employment, it is still legal for a person with inherited thrombophilia to be denied life or disability insurance based upon the positive test and if they do get insurance, it is allowable to pay higher life, disability, or long-term care insurance premiums.  Existing GINA protections with respect to health insurance and employment are also under threat…several recent Congressional proposals call into question the long-term protections of one’s genetic results. Laws can always be changed.  Protections provided today may not be in place tomorrow. For that reason, patients should not treat genetic testing as a light decision, but rather be aware that both traditional clinic based testing and direct-to-consumer testing carries potential discrimination risks and these risks should be weighed with the benefits of testing.
  4. Peace of mind.  I can foresee a negative result from a direct-to-consumer test providing peace of mind without the cost and potential hassles of diagnostic testing. Any positive test will need to be followed up with a clinician and perhaps a confirmatory diagnostic test to confirm herto- or homozygous status….but this should be a smaller number of people as even the most common thrombophilia is found in less than 10 percent of the population.  In other words, the 23andMe could be used as an inexpensive, personal first step screen test for the most common thrombophilias, because statistically the majority of people will have a negative result.  Only those positive need to move on to the more expensive, diagnostic panel.

There is no 100% right or wrong answer when it comes to testing for genetic thrombophilia. In the end, it comes down to individualized patient decisions..decisions hopefully made with full information in hand.   It will be interesting to see how this new era of consumer driven thrombophilia testing evolves.

Snapshot of how immigration policy impacts healthcare

Immigrants are an integral part of our health care system.  I’ll let the statistics speak for themselves:


Nationally, 1 in 4 physicians, 1 in 5  nurses and home health aides and 1 in 6 dentists & pharmacists are foreign-born. (Reference source 1, source 2 ) Women account for 75% of these foreign-born health care employees and are the majority gender (among immigrants) in every health care field except as physician and surgeons.(ref)

In addition to front-line clinicians, health care researchers play a vital role in the study of disease and the development new treatments and drugs. Nationally, 24.89 percent of medical scientists working in the US are foreign-born. (ref)

Data from 2014 shows 24.2% of US physicians graduated from an international medical school, reflecting a population that is predominately immigrant.(ref)   Among medical residents and fellows, 25.4% attended an international medical school.(ref)

Most foreign-born health care workers become naturalized US citizens–2/3 (66 percent) have obtained citizenship.(ref)

Why do these statistics matter to patients?

One additional statistic sums up why immigration policy should matter to all patients, of all political perspectives:  Current estimates suggest that the United States will face a shortage of 46,100 to 90,400 physicians by 2025.(ref) This figure is only physicians–when you account for shortages in nursing and home health, the problem become far more acute and hits rural and traditionally under-served areas the hardest. Quite simply, US-born students are not entering the health care professions at rates high enough to meet the patient population demand.

The result should be common sense…no matter how great your insurance might be, if there isn’t a health professional readily available, you will not be able to access timely care.  Regardless of how you feel about immigration policy politically, your health and ability to access health care will be impacted by both more restrictive and unpredictable immigration laws. It is a bi-partisan statistical fact that the degree of quality care we have come to expect from our health institutions depends heavily upon foreign-born professionals.  To ignore this obvious truth is to put patient lives at greater risk.

*EXCLUSIVE* Flawed federal reports used for health policy and funding decisions



wp-cdc-reportThis week, several national news organizations ran a story on a new CDC study which showed rural Americans were more likely to die from the top 5 causes of death than their urban counterparts. Per the study, “the five leading causes of death in the United States during 1999–2014 were heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke”. While the report results shocked, the data upon which the conclusion is based is deeply flawed, containing a statistical error–an error which my investigation found to be contained in other far more critical HHS reports provided by mandate to the President and Congress.

In short, the error result is a significant over-inflation of the mortality burden of heart disease in America while under-reporting the impact of venous thromboembolism.  To understand the life-and-death implications of how one tiny error can cascade throughout the health system without question, first let’s clearly define what we mean by these two medical terms, both in lay terms and in statistical analysis.

What is considered heart disease?

When you hear the term ‘heart disease’, what do you think of?  Heart attack and cardiac arrest, right?   That’s also what our health agencies educate the public.  From the NIH’s National Heart, Lung, and Blood Institute:

“Coronary heart disease—often simply called heart disease—is the main form of heart disease. It is a disorder of the blood vessels of the heart that can lead to heart attack. A heart attack happens when an artery becomes blocked, preventing oxygen and nutrients from getting to the heart. Heart disease is one of several cardiovascular diseases, which are diseases of the heart and blood vessel system. Other cardiovascular diseases include stroke, high blood pressure, angina (chest pain), and rheumatic heart disease.”

Clinical researchers define heart disease more precisely using the International Classification of Diseases, Tenth Revision (ICD-10), a system used by healthcare providers to code all diagnoses and procedures.  All Health Insurance Portability and Accountability Act-covered entities are mandated by the U.S Department of Health and Human Services to use this classification system. It’s primary application is for billing and reimbursement purposes, but the data collected also provides epidemiological researchers a way to look for the incidence and distribution of specific medical conditions.  Here’s how the CDC researchers in the referenced study used ICD-10 codes to define ‘heart disease’:

Heart disease here is defined as ICD-10 codes: I00-I09, I11, I13, and I20–I51.

The problem with this definition is that these ICD-10 codes capture far more than merely heart attack and cardiac arrest.   For example, this range includes code I26, the code for pulmonary embolism.

icd-10-peA pulmonary embolism (PE) is a blood clot in the lung.  Per the NIH National Heart, Lung and Blood Institute:

“PE most often is a complication of a condition called deep vein thrombosis (DVT). In DVT, blood clots form in the deep veins of the body—most often in the legs. These clots can break free, travel through the bloodstream to the lungs, and block an artery.”

“If a blood clot is large, or if there are many clots, PE can cause death.”

While a pulmonary embolism is a blood clot which lodges in a pulmonary artery of the lung to block blood flow, it’s etiology is venous.  “A PE occurs when a blood clot breaks off from a DVT and travels through the blood stream, traversing the right atrium and right ventricle, and lodging in the lung.” Why is this distinction important?  Because….

All blood clots are not equal

Clots in arteries and clots in veins have different risk factors, treatments and risks for recurrence. They are therefore prevented in different ways.

  • Blood clots which form in arteries lead to: stroke, TIA (mini-stroke), heart attack (myocardial infarction), and peripheral arterial clots.
  • Blood clots which form in veins lead to: venous thromboembolism (VTE) which is a term used for both pulmonary embolism-PE (lung clot) and deep vein thrombosis-DVT (most commonly leg).  VTE =  DVT + PE.

Why this matters:  follow the money

In practical terms, if you are a public health official and you want to design a program to prevent blood clots, you’ll need a very different educational tact for tackling heart attack and stroke (arterial clots) than you will deep vein thrombosis and pulmonary embolism (venous clots).  Different causes = different prevention strategies.

For a heart attack prevention program, you’d focus your educational outreach on risk factors such as cholesterol, blood pressure, obesity, and smoking.  For VTE prevention, you’d focus education on risk factors such as hospitalization, cancer, pregnancy, oral contraceptive use and travel.   Very different messages. Very different audiences to educate.

CDC Division of Heart Disease & Stroke Prevention

Even though the CDC includes pulmonary embolism in the ICD-10 codes it pulls to define ‘heart disease’, in policy practice, PE is excluded from heart disease prevention efforts. The CDC has an entire division dedicated to heart disease and the prevention of heart attack and stroke–the Division for Heart Disease and Stroke Prevention.  Absolutely no where will you find a single mention of pulmonary embolism on the Divisions’s website–no prevention information, no programs in place, no resources allocated. 

This exclusion simply reflects how most non-researchers think of what constitutes ‘heart disease’–it is heart attack and stroke, not deep vein thrombosis or pulmonary embolism.

Yet because researchers do include pulmonary embolism in their statistical definitions of ‘heart disease’, their data over-inflates both the incidence and burden of true heart disease (heart attack and stroke) while downplaying the significance of PE and it’s underlying cause, DVT.   The data makes heart disease look much bigger than it is which translates into  a stronger policy  case for tax-funded  programs aimed at heart disease…which in practice are  programs exclusively targeting heart attack and stroke.

A widespread error in numerous reports used by the President, Congress, reporters and the public

cdc-health-reportThe  flawed definition of ‘heart disease’ is not limited to this week’s small CDC report.  The same definition appears in the 461 page benchmark report, Health, United States, 2015, “submitted by the Secretary of the Department of Health and Human Services to the President and the Congress of the United States in compliance with Section 308 of the Public Health Service Act”.  This mandated report is compiled annually by the CDC to present national trends in health statistics.  It’s data, provided by the CDC Center for Health Statistics, is often used to make the cases for many critical policy and funding decisions.

This report, and the companion monthly vital statistics data update reports, do not present all causes of death, but rather only 113 select causes of death.  VTE is not one of them, but heart disease is.  Unfortunately,  heart disease is also wrongly defined in these reports by including the ICD-10 codes for pulmonary embolism.


source: CDC National Vital Statistics Report

To sum:  The key reports provided to the President and Congress for the purpose of making critical health policy and funding decisions are flawed.  It overstates the burden of heart disease and under-reports deadly, preventable pulmonary embolism. 

What are the true top 5 causes of death?

Because pulmonary embolism is wrapped up in the statistical definition of ‘heart disease’, it does not get it’s own attribution as a ’cause of death’. If VTE were pulled out and reported separately, where might it rank?

If VTE were included, it would be the 3rd top cause of death
Table Source:  CDC https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

The CDC estimates upwards of 900,000 new VTE cases each year, with 300,000 deaths from pulmonary embolism.  This would place VTE among the top 3 causes of death…more than AIDS, breast cancer and car accidents combined. VTE deaths in America even exceed (by 26 times more!) those due to firearm homicides which we hear more about, which the CDC places at 11,208.  Even opiods–which just weeks ago in December 2016 both President Obama and CDC Director Thomas Freiden called ‘an epidemic’–kills far fewer persons at 52,000 Americans annually.

Another implication:  if you take away the pulmonary embolism cases from the ‘heart disease’ category, then cancer would move up the list as a cause of death, likely making it the true #1 cause of death among Americans rather than heart disease.

Implication:  A public health threat goes ignored

That heart disease figures are over-stated might not be cause for alarm if VTE was being addressed in other meaningful ways.  It isn’t.

The CDC’s FY 2017 Congressional budget justification includes $87 million by name for two other thrombotic conditions, heart disease and stroke,  there is no line-item specifically for VTE which by the CDC’s own mortality figures, kills more Americans annually than stroke

CDC’s FY 2017 Congressional budget justification

While there is no line-item funding allocation for VTE as you find with other conditions and it’s not included in the mission of the Division for Heart Disease and Stroke Prevention, that is not to say there is not some effort to address VTE by the CDC within its budgetary constraints.   Found within the CDC National Center on Birth Defects and Developmental Disabilities (NCBDDD) is a $4.5 million line-item titled “Public Health Approach to Blood Disorders”.  It is from a portion of these funds and within this division that current CDC efforts to address VTE arise. Past efforts have included creating a Flickr album of patient stories and hosting a webinar for health care professionals. As a VTE survivor and thrombosis educator, I was pleased to contribute to both these educational efforts.  However, despite good intentions to do the most possible with the available resources, we must admit that these are relatively low-impact, virtual based efforts when held in comparison to the more interventional-type methodologies employed to address other preventable medical conditions. For comparison, take a look at the national, hands-on network of programs the CDC has implemented for stroke.

 Impact on public perceptions and lives

A consequence of the current flawed methodology is that it is difficult to advocate for what isn’t reported correctly. What is reported widely as the ‘top causes of death’ influences public perceptions and more importantly, it impacts where policymakers choose to focus limited public health funding.

If we want to call VTE ‘heart disease’, fine, but then our public health agencies whose mission is to tackle heart disease should be utilizing their funds to develop VTE prevention programs. But to present a false picture to the public (and funding lawmakers) of the burdens of both heart disease and venous thromboembolism…well, that’s just plain wrong and people are dying as a result.

How?  Because funds are not being invested on conditions where they are truly most needed. Most VTE are preventable. Nearly a third of VTE result in death. The Agency for Healthcare Research and Quality (AHRQ) calls VTE “the most common preventable cause of hospital death”.  There are effective prevention, diagnostic and treatment strategies. Yet, it is hard to argue that VTE is a serious problem which needs funding and dedicated efforts when it doesn’t even show up on on the most commonly utilized and widely distributed lists of causes of death and disability.

Needed action

I do not like to point out a problem without offering a solution.

A 2008 Surgeon General Call to Action report found VTE was “a major public health problem, exacting a significant human and economic toll on the Nation”. The report found gaps existed in the systematic application of clinical knowledge and that the condition itself suffered from low public awareness….both ideal preconditions for a coordinated public health intervention to have impact. But we’re so far off from where we need to be that it is going to take funding attached to a Congressional mandate to create one.

While we would like to ideally think that our public health agencies prioritize those medical conditions which pose the greatest threat to American’s morbidity and mortality, this is not the case. While there are effective strategies to prevent and treat VTE, it is a largely ignored public health concern.

CDC is the agency charged with protecting the public health from preventable conditions. The problem with the current CDC approach to VTE is 2 fold:

  1. VTE is not a blood disorder. It is also not heart disease.  VTE is a cardiovascular event. There are identifiable risk factors for VTE–such as hospitalization, immobility, cancer, long-distance travel, oral contraceptives, pregnancy, advanced age. So it doesn’t fit neatly within the mission scope and skill set of an administrative unit at CDC which primarily addresses conditions acquired at birth, which is where the topic is languishing now. To capitalize on existing expertise and tap economies of scale, it should be addressed by the same administrative unit as the other 2 major thrombosis-related conditions–heart disease and stroke–within the National Center for Chronic Disease Prevention and Health Promotion.
  2. Because VTE is not mentioned by name, with a line-item expressly for it, funds in the ‘Public Health Approach to Blood Disorders’ line can easily be diverted and utilized on non-VTE educational activities, which has been seen in past years. The only way to ensure funds are utilized for VTE is for it to have its own, clearly named line-item allocation.
To clean up our health data  and target VTE, the President and Congress need to:
  1. Establish a task force (as has been done for other conditions)  to review, consolidate and coordinate all US VTE efforts across federal agency stakeholders–CDC, CMS, AHRQ, NIH, FDA, HRSA, Veterans Affairs, Rural Health.  Currently, efforts are siloed reflecting a lack of cross-agency collaboration.
  2. Make a clearly named VTE line-item funding allocation.
    1. Funds should carry the mandate that they can only be utilized for VTE, prohibiting the ability to divert funds towards other conditions.
    2. A clear line of reporting and accountability should be implemented with attached funds to ensure results.
      1. If it is determined that CDC should maintain responsibility for public health prevention of VTE, then a clearly named VTE line-item funding allocation must be made within the same CDC administrative unit that addresses other thrombotic conditions–the National Center for Chronic Disease Prevention and Health Promotion.  If another agency is chosen, VTE should be paired with related thrombotic conditions to take advantage of existing expertise.  If VTE is going to be statistically treated like heart disease, it should get the corresponding resources to go with it.
  3. Establish a work group to review current health data reports and decide upon a consistent methodology for data definitions.  I recognized the coding issue with pulmonary embolism because I know this condition very well, but it calls into question…could there be flaws in the definitions of other medical conditions?   We have become such a data-driven system for decision making, we need to have confidence in the quality of the data.  A thorough review and revision is in order.


  1. Moy E, Garcia MC, Bastian B, et al. Leading Causes of Death in Nonmetropolitan and Metropolitan Areas — United States, 1999–2014. MMWR Surveill Summ 2017;66(No. SS-1):1–8. DOI: http://dx.doi.org/10.15585/mmwr.ss6601a1.

I corresponded with the CDC study author, Dr. Enest Moy, who was promptly responsive, polite and helpful (emails copied below).  He confirmed that indeed, the codes for pulmonary embolism are included in the statistical definition of heart disease. However  I’m told the fix may be difficult and their data shows that even if PE were pulled out separately it would only account for 7,000-9,000 deaths which is far fewer than reported by other HHS agencies (CDC,AHRQ,CMS)and independent academic researchers funded by HHS (CDC,NIH) to study the epidemiology and incidence of VTE.(Significant CDC and NIH funded work in the field of modeling VTE incidence data has been led by Dr John Heit of the Mayo Clinic, see publication citation) Without digging further to understand the disparity, I cannot say for certain why different agencies have different death figures, but clearly  not all these figures can be correct…the disparity is too wide.  I suspect the difference may be due to how a cause of death is defined between various datasets. Additionally, death certificate data is notoriously inaccurate when it comes to pulmonary embolism.  Again, I cannot say based upon the information at hand, but this makes a stronger case for my recommendation #3:  that a consistent methodology is needed across federal health data reports. If we’re making policy and funding decisions based upon data, we need clean, trustworthy data. At the moment, I don’t have full confidence in the data I’ve seen.  BW

If everything is called a ‘crisis’ or ‘epidemic’, is anything?    What gets the most attention (and funding) isn’t what is most likely to kill you.

Crisis.  Epidemic.  Public health treat.   These words are routinely bandied about to describe a host of conditions that can kill you.  A quick Google news search of January 6, 2017 returned nearly 4 million results of headline making ‘epidemic’ articles; the top 4 topics:  opioids, flu, stress and gun violence.

Google news search results 1/6/17
Google news search results 1/6/17

Without reading a single word, intuition alone tells us that anything called ‘epidemic’ or ‘threat’ surely must be a bad thing and ‘crisis’ denotes an urgent peak of activity that should not be ignored.  The mental fear seed is planted.

headline-nytTo get the public to rally around a public health issue—and to accept why it warrants government effort and funding—the case if often made in terms of how many Americans are killed by it.pink-white-house

  • Example:  In December, the CDC announced that opiods now kill 52,000 Americans annually, prompting CDC Director Thomas Frieden to describe it as a “crisis” and an “epidemic”. “It is urgent and critical that we rescue people whose lives are at immediate risk,” wrote Frieden in a Fox News opinion piece, adding “More providers need to be trained and offer this evidence-based, life-saving treatment.”headline-rs
  • In November, when the health topic-du-jour was the HIV/AIDS epidemic on World AIDS Day, a giant red ribbon was hoisted up on the White House’s North Portico to draw attention to the condition attributed to 6,721 annual deaths. President Obama issued a video statement and proclamation calling upon people to  “rededicate ourselves to ending this epidemic once and for all”headline-medscape
  • In October, when the White House was illuminated all in pink for breast cancer awareness, it honored the 40,860 Americans who die annually from the condition because as a Presidential Proclamation said “too many are touched by the pain and hardship caused by breast cancer.”
  • Per the CDC, gun violence killed 10,945 Americans in 2014. In a January 7, 2016 op-ed for the New York Times, President Obama said  in the first sentence “The epidemic of gun violence in our country is a crisis.”

These highly visible PR efforts are fine and proper to rally the public’s attention so we all will agree ‘wow, that’s huge, let’s throw some funding towards fighting that’.   But there is a dark reality: for every potential cause of death which rises to the top of the public health PR playbook, it is at the cost of other preventable conditions which get no attention or funding, some which kill far greater scores of citizens.

Now, this next part involves fun with statistics and science, but hang with me a tad and you might not be so alarmed by the next fear-inducing health headline you read about what’s going to kill you.

Consider one condition:  venous thromboembolism (VTE).  Don’t let the name scare you…it’s just a big medical term for a blood clot that occurs in a vein.  It includes, among others, clots you may have heard about like deep vein thrombosis (DVT) and pulmonary embolism.

VTE is fairly common.  The Center for Disease Control and Prevention (CDC) says it impacts upwards of 900,000 Americans each year.

And it’s also deadly.  According to the Agency for Health Care Research and Quality—that would be the government agency who produces evidence to make healthcare safe and equitable—VTE is “the most common preventable cause of hospital death.”

Betcha didn’t know that factoid the last time you were lying in a hospital bed more worried about whether the doctor washed her hands than if a clot was growing in your leg.

CDC says VTE “can happen to anybody at any age and cause serious illness, disability, and in some cases, death.”

Egads!  Healthy, young people get clots too!

The Surgeon General way back in 2008 said VTE “represent a major public health problem, exacting a significant human and economic toll on the Nation.”


So three government sources have cast VTE as serious, deadly and common.  But where do VTE deaths rank among the conditions which have received the ‘crisis’, ‘epidemic’ and ‘threat’ labels?

VTE  is, in fact, the #3 cause of overall death in America—more than opiods, AIDS and gun violence combined. Yet it is excluded from benchmark federal vital statistics reports.  No reporting = no funding.

According to a 2015 CDC study, exact figures are difficult to come by because there is no national surveillance system for VTE.  In other words, since we’re not formally counting, we don’t know. But estimates from the various government funded researchers place VTE deaths anywhere from as few as 100,000 to as much as 600,000 annually.  The consensus estimate is around 300,000 preventable deaths.  If accurate, then VTE would be the #3 cause of overall death in America—more than opiods, AIDS and gun violence combined.  It’s even more than stroke, diabetes, Alzheimer’s disease, breast cancer and the flu.

If VTE were included, it would be the 3rd top cause of death
If VTE were included, it would be the 3rd top cause of death

Yet you’ll never see this acknowledged in any government-issued report on what’s killing Americans.  Why?  Because the benchmark CDC National Vital Statistic Report includes only 113 ‘select’ causes of death and VTE is not one of them.  Since VTE is excluded from the source dataset as a defined cause of death, it doesn’t make it into the final reporting.

The implications of VTE being excluded are enormous.  Public health policy is being made based upon bad data.  Funding decisions are based on reports which policymakers assume are a complete and accurate report of public health needs.  It isn’t.

As a result, VTE get $0 named funding allocation in the federal budget.  Zero. By comparison, a condition such as AIDS gets $31.7 billion.  The recently passed 21rst century’s cures act included $1 billion expressly for opiods.

This inequity must stop if we are to truly allocate limited resources in the most efficient way possible to address the preventable causes of death causing the greatest public harm. It is nothing short of a statistical abomination that the #3 cause of death in America is intentionally not reported in taxpayer funded reports to policymakers who determine the nation’s public health priorities.

While VTE is a common and serious condition, effective evidence-based prevention and treatment strategies exist.  Yet these life-saving measures cannot be implemented if both the public and clinicians aren’t adequately educated about them.  Knowledge alone cannot save lives without action; we can’t act upon that which is kept from us.

Fishing for patient plaintiffs

My caller id revealed I received numerous calls in the past few weeks from multiple phone numbers and area codes, but all with the same name of “Xarelto Claims”.  Of course, I knew from the start this had to be one of those ‘Have you been harmed?’ law firms but as a patient advocate, I was curious and decided to talk to them.

What is Xarelto?  Xarelto is the brand name for the FDA approved anticoagulant (blood thinner) rivaroxaban. It is used to treat and prevent blood clots: to reduce the risk of stroke in patients with atrial fibrillation and to treat/prevent venous thromboembolism (deep vein thrombosis and pulmonary embolism).  It is marketed in the US by Janssen Pharmaceuticals. 

When ‘Xarelto Claims’ called next time, I answered.  A recording indicated the call was from the nebulous name ‘Legal System Review’ and I was then transferred to speak with someone who had important information related to my health.

A nice, but scripted woman, came on the line–with classic call center sounds in the background.  She informed me that I could be a VICTIM and was due COMPENSATION because I’d been exposed to a BAD DRUG and that if after her screening questions I was found to be eligible for FREE LEGAL SERVICES I would be put in touch with a case manager and injury attorney in my area.

I asked her how her company obtained my personal medical information to know I’d taken a blood thinner.  She said that I’d indicated I wanted to received information from them.

Nope, I certainly did no such thing…try again. I asked again, how do you know my prescription history?

Again, she was insistent I had somehow opted in to receive a call from her company.  She then asked me to confirm that I’d taken Xarelto.

As a blood clot patient for 13 years, I’ve taken six different anticoagulants (oral and injectible) and so I could honestly answer yes in going along with this call.  I asked her ‘Is there a problem with this drug?”

She said, “oh you’ve obviously not heard about the issues” and with such great concern for me and my health she informed me about how it is ‘under investigation’ for numerous harms.

She next asked me if I’d experienced any excessive bleeding resulting in a whole host of nastily described issues (including death).  Um, nope I’m on the call and alive and well, thanks.  No issues to report.

< CLICK >  She hung up.   As soon as I said I’d not had any major bleeding, she didn’t even say goodbye but disconnected the line.

Clearly these companies are not truly concerned about the health of the people they call when they intentionally put the fear of injury and death into a patient and then drop them like hot lava when they find out they can’t get a litigation dime out of them.  Yet far too many patients are lured in by the scam and become afraid to take their medication not understanding that ALL anticoagulants (blood thinners) can cause bleeding.  Bleeding is a known, fundamental side effect of ANY blood thinner…they work to help prevent clots in your body because they increase the time it takes for blood to form a clot. Now, there are differences in potential risk for bleeding among the various anticoagulants and differences in their ability to be reversed in the event of an emergent situation. And, some drugs are newer and thus there is less real-world experience in their management.  Still, on the most basic level, all anticoagulants come with a risk of bleeding.

You can’t escape the ads and the message they instill. I even had a family member call me once to ask “please tell me you’re not taking XYZ drug” because she had seen an ad in the newspaper about ‘serious side effects’.  What makes me truly sad is that far more money in our society goes towards mis-educating patients than towards educating patients.  I can say this with confidence as I directed a thrombosis patient education program until funds for such ran out because ‘education isn’t profitable’.  I rather doubt the injury attorneys have this problem…if they can afford to buy lists of patients to robocall and take out prolific media ads, they are clearly finding enough plaintiffs to make the endeavor profitable.

To be clear, patient harm is a real thing and I don’t wish to diminish that fact.  Yet my observation is that following a legitimate harm, it is the patient and family who are fired up enough to proactively go out and seek resolution and restitution. They don’t sit by and wait for an attorney to robocall them before deciding to take action…they find their own counsel, they get engaged with nonprofits, they promote education, they try to make the system safer for the next patient coming along.

These aggressive personal injury attorneys are merely seeking warm bodies to add to their portfolio–to convince patients who were otherwise perfectly ok with their treatment regime that if they merely say the right thing, they might be able to profit. Such activity is a detriment to patients who are truly harmed and it increases the health care costs for all of us.

So how did a personal injury attorney learn my prescription history or at least narrow me down as a person who ‘might’ be taking an anticoagulant?  No way to know for certain, but it will surprise many to know that prescription history is not necessarily private.  According to the nonprofit Patient Privacy Rights:

“Q. Are my prescriptions private?
A. No. All 51,000 pharmacies in the U.S. are wired for data mining. You cannot keep your prescriptions private, even if you pay cash. Selling prescription records is a multi-billion dollar a year industry: In 2006 IMS Health reported revenues of $2 Billion for selling prescription records (that’s just one company!).”

In fairness, data mining information is supposed to be stripped of personal identification..such as name….yet, even with allowable aggregate data (prescription, town, physician name) it is not difficult for a marketer to do some cross referencing and narrow down a target demographic profile.

Blood clot facts relevant to the 2016 Presidential campaign

There is one issue which has not yet received much scrutiny during the primary season which is sure to gain focus during the general election–the physical fitness of each candidate.  If elected, Trump would become our oldest President while Clinton would become the first Commander-in-Chief on long-term anticoagulation to prevent the recurrence of venous blood clots. While there was a time when the health of a candidate was considered too personal to broach, in this election season where the most personal of attacks are the norm, pre-existing conditions will certainly be on the table for discussion.

Clinton has the largest elephant in the room with three documented clotting events—in 1998, 2009 and 2012; according to the statement of health issued by her personal physician.(REF 1)  I’ve read much mis-information about these events…most people don’t appreciate the nuances between various types of blood clots (arterial, venous), their location (leg, lung, brain, etc), the various treatment options, risk factors for recurrence, etc. And when we inevitably hear the clotting history brought up again during the general campaign, we are sure to hear even more mis-information.  So I’m going to lay out some facts about these types of blood clots now and connect it to what is known about Clinton’s clotting experience.

Blood clots defined

For greater understanding, let’s get a few basics out of the way first.   Arteries are the blood vessels that carry blood away from the heart to the extremities.  Veins are the blood vessels which carry blood back to the heart from the extremities.

Clots in arteries and veins are different.  Blood clots which form in arteries lead to stroke, TIA (mini-stroke), heart attack (myocardial infarction), and peripheral arterial clots.  Blood clots which form in veins lead to venous thromboembolism (VTE) (2). VTE is the broad term which encompasses clots which form in a deep vein of the body and they may go by several names, depending on the location of the clot:  deep vein thrombosis (DVT), pulmonary embolism (PE), sinus vein thrombosis (SVT), cerebral vein thrombosis(CVT), portal vein thrombosis (PVT), mesenteric vein thrombosis (MVT).  Clots in arteries and clots in veins have different risk factors, treatments and risks for recurrence.

  • Note that each of Clinton’s clots have been in a vein:  2 DVT and 1 SVT.   Importantly, contrary to some misinterpretations, not all clots in the brain are stroke.  A SVT (sinus vein thrombosis) is NOT the same as stroke (stroke is an arterial clot) nor does it occur in the sinuses!  The ‘sinus vein’ is a deep vein in the brain.(15)SVT is therefore a venous clot (VTE).

Around 900,000 Americans a year are diagnosed with VTE, according to the CDC.(2)  VTE is the third leading cause of death, with an estimated 300,000 deaths annually.(16) VTE can happen to anyone—from young athletes and pregnant women to cancer patients and the elderly. There are identifiable risk factors for VTE such as recent hospitalization, cancer, pregnancy, hormone replacement therapy, long-distance travel, clotting disorders, past history of clot. More information and statistics can be found at the end of this article, but for now let’s simply establish that VTE is a serious, sudden, potentially life-threatening condition with long-term health and psychological implications.(3)

Risk of recurrence

The statistics are unnerving—around 30% of patients die within the first 3 months following diagnosis of VTE, most deaths are immediate with no warning.(4) Once you have a VTE, you are at increased risk for another.  Repeat clotting episodes are not unusual—nearly half of VTE survivors will experience another clot within ten years.(5)  Clinton’s history of 3 clots within 13 years exemplifies this increased threat rather well.

HRC lovenoxThe release of Clinton’s emails earlier this year provided some detail on how she has previously managed her clot risk.  A December 22, 2011 email from aide Huma Abedin to Clinton while she was traveling in Prague reminders her to take Lovenox.(17) Lovenox is the brand name for a low-molecular weight herparin which goes by the generic name enoxaparin, an injectible anticoagulant (blood thinner). Taking an anticoagulant during higher clot risk situations (like long-distance travel) as a prophylaxis is not unusual for persons with a previous VTE history.

Post-thrombotic limitations

Around half of deep vein thrombosis survivors will experience some level of post-thrombotic complication due to blood vessel damage caused by the clot, such as chronic pain, swelling and reduced mobility.(5)  For most patients, these long-term effects mainly pose mild to moderate quality of life effects. However, for around 10% of patients, complications can be severe and disabling.(6) It is unknown if Clinton experiences any post-thrombotic issues; none have been mentioned.

Almost 80% of patients with sinus or cerebral vein thrombosis fully recover (Ref 14) while around 50% of deep vein thrombosis patients recover without chronic issues (Ref 15).

Treatment risks

While effective strategies exist to treat and prevent clots, none are fully benign and without risk. Clinton takes an anticoagulant medication (sometimes referred to as a ‘blood thinner’) to prevent a clot recurrence.  While these medications are truly life-saving, they also come with their own worrisome issues, namely an increased risk of bleeding.  Anticoagulants increase the time it takes for the blood to form a clot; which is a desirable thing if the goal is to prevent a VTE from forming. Yet, there are situations when we need our blood to clot quickly, such as with injury.

All anticoagulants increase the risk for bleeding, but the level of this risk varies depending on the specific drug.  Clinton’s physician says she currently takes warfarin (Coumadin) which has a bleeding frequency of 15-20% per year and a life-threatening bleeding rate of 1-3% per year.(7) Managing anticoagulation well is crucial to avoid such complications.  Unfortunately, warfarin is notoriously difficult to manage because its blood thinning effect is highly influenced by diet, medications and lifestyle factors. For this reason, frequent blood testing and dosage changes are necessary to ensure just the right balance of drug.  Too little drug metabolized puts one at increased risk of clotting while with too much, one is at higher risk of bleeding.(8)

There are four additional oral anticoagulants which have been FDA approved in recent years as alternatives to warfarin to treat and prevent VTE.(9) While they are easier to manage than warfarin, these too come with their own unique risks, namely that for 3 of the 4, no FDA approved reversal agent currently exists in the event of a major, life-threatening bleed.  So the choice of treatment for patients like Clinton is not an easy one—an established, but  finicky drug that is difficult to manage or an easy-to-manage drug which is so new that it has no reversal agent.   And with all choices, a risk of bleeding and clotting remains.  No drug is a 100% sure fire bet.

Psychological impact

High levels of anxiety, depression and psychological stress have been reported among patients with VTE.(3)   Numerous studies have found that the psychological consequences of experiencing VTE are considerable and it is no wonder given the many fears associated with diagnosis, cause, recurrence, bleeding, impact on family, coupled with any chronic complications or clotting disorders.(10)  I have published work in this area, writing for the medical journal Circulation that “it is normal to feel shock, anxiety and fear following the diagnosis of a blood clot.”(11)  How an individual responds to their VTE event and treatment regime is as variable as the type of persons who experience VTE.  For some patients, VTE is perceived as ‘no big deal’; for others, it is a life-altering event. What is Clinton’s patient perspective? We don’t know, she has not publicly talked about her clot experience.

Inaccuracy of medical statement

HRC health letter snipMuch of what we know about Clinton’s clot history comes from her physicians medical statement, released by the Clinton campaign in July 2015.  It should be noted that one detail in thepublic letter  is inaccurate.  In detailing the 2012 episode, Dr. Lisa Bardack says

“Mrs. Clinton was found to have a transverse sinus venous thrombosis and began anticoagulation therapy to dissolve the clot.

The problem with this statement is that anticoagulants DO NOT dissolve blood clots. Anticoagulants prevent existing clots from growing larger and new clots from forming. It is the body itself which, over time, naturally breaks down blood clot material. Put differently…As I wrote in the peer-reviewed medical journal Circulation:

Anticoagulants  “increase the time it takes for blood to clot. They prevent new clots from forming and existing clots from growing larger. Anticoagulants do not dissolve a clot. The body naturally dissolves a clot over time, sometimes completely, sometimes only partially.” (11)

Clot-dissolving drugs do exist, called thrombolytics. For venous clots,  a fibrinolytic drug is given via an intravenous line. (14)  There is nothing in Dr. Bardack’s statement referencing such fibrinolytic drugs, only anticoagulants. This is not surprising because fibrinolytic drugs are typically not used in cerebral or sinus vein thrombosis (the type of clot which Mrs Clinton had in 2012) due to the risk of bleeding in sensitive brain tissue.(15)

As I have written, once again in the peer-reviewed medical journal Circulation, on this very topic of treatment of sinus vein thrombosis: “Clot busting drugs (known as fibrinolytic drugs) are typically not given, because they may increase the risk of bleeding into the brain. Radiological or surgical procedures with catheters to break up and extract the clot (called thrombectomy and endovascular therapy) are done only in severe cases and in patients who get worse despite adequate blood thinning therapy.”) (15)

Therefore the statement that “Mrs. Clinton was found to have a transverse sinus venous thrombosis and began anticoagulation therapy to dissolve the clot” is inaccurate.

Policy implications

If Clinton were President, would this have an impact on funding for blood clot education and research?  Let’s look at the past as a guide.

The Surgeon General in a 2008 Call to Action identified VTE as “a major health problem, exacting a significant human and economic toll on the Nation“. (4) The report said few problems are as serious as VTE, yet there was low public awareness and clinician adherence to effective prevention and treatment strategies.  The report laid out a blueprint for change to serve as a catalyst for future VTE policy activity.

Unfortunately, little happened after the Surgeon General’s report was released, especially in the priority area of federal funding.  President Obama’s Fiscal Year 2017 budget proposal includes no named funding at all to address VTE.(12) By comparison, a more publicly aware condition such as HIV/AIDs gets a $3.3 billion allocation yet there is not a single budgetary mention of VTE which kills more Americans annually than AIDs, breast cancer and car crashes COMBINED.(13)

Could Clinton play a key role in changing that funding inequality?  Perhaps, but we’ve not witnessed this during past opportunities. Clinton’s first clot occurred in when she was First Lady.  Her second episode occurred the year she transitioned from the US Senate to the State Department.  Her third VTE episode happened while she was Secretary of State.  All of Clinton’s clots occurred while she held positions of great public influence.  It could be argued that if at any of those junctures, she had stepped up to share her clotting experience in a public way, perhaps even become a VTE advocate and encouraged Congress or the President to increase funding, millions of lives could have potentially been positively impacted or saved. Whether she might advocate differently as President is unknown.

The mere presence of a Commander-in-Chief on anticoagulation with a clotting history may help change federal viewpoints related to military members with similar clotting concerns. Hypercoagulable states which require chronic anticoagulation are grounds for service members to be classified nondeployable, thus impacting their ability to remain on active duty status.(29) If Clinton’s example increases awareness of blood clots, there is the potential to educate and change individual perceptions of what is considered acceptable risk for anticoagulated persons.

It is also unlikely that Former President Bill Clinton would take advantage of renewed public spotlight to advocate for VTE as he has intentionally avoided the topic when given past good opportunities with speeches and foundation work.

Conclusion: Past Presidents & Vice-presidents with Clots

PresidentsClotHistoryI hope this has provided some fact based perspective to a topic which I suspect will be given more attention prior to the general election.  As a VTE survivor on long-term anticoagulation myself, it is of course difficult for me to be objective–it’s something I live with daily.  I personally would very much like to see Clinton speak up about her clot experience and advocate for patients, help bring about a VTE funding line-item in the federal budget, and push for more coordinated federal efforts…but realistically, I just don’t think that’s going to happen.

Interesting side note: Clinton is not the first politician with a VTE history–Richard Nixon (1965 & 1974) and Dick Cheney (2007) are two with a DVT history that immediately come to mind, Dan Quayle had a pulmonary embolism (1994) and Teddy Roosevelt died of a pulmonary embolism (1919).  Nor would Clinton be the first anticoagulated President–Eisenhower was treated with warfarin in1955 following a heart attack (arterial clot) andGeorge HW Bush was placed on warfarinto manage atrial fibrillation in 1991 (to prevent stroke/arterial clot). Clinton would however be the first (to my knowledge) President with a SVT history on long-term anticoagulation.


Facts about VTE

VTE is a leading cause of death and disability:

  • Over 900,000 Americans have a VTE event each year and it causes more deaths than breast cancer, AIDS and car crashes combined.(18, 19)
  • VTE is the third leading cause of death, but is not widely known because VTE is excluded from CDC Vital Statistic reports which reflect only 113 select causes of death.(20)
  • Upwards of a third of VTE patients die within one month of diagnosis.(21)
  • Even with optimal medical care, half of VTE patients will have long-term complications and one-third will have a recurrent clot within 10 years.(22)
  • VTE is the leading cause of preventable hospital deaths in the United States. ~60% of VTE are associated with hospitalization.(23)
  • VTE is the leading cause of maternal death in the United States.(24)
  • An estimated $7-12 billion in medical costs in the US each year can be attributed to DVT and PE.(25)
  • High levels of anxiety, depression and psychological stress have been reported among patients with VTE.(26)

By comparison to other better known conditions:

  • AIDS funding = $31.7 billion[11], CDC portion of AIDS funding = $927.8 million(27)
  • Breast & cervical cancer funding (in 1 combined line-item), CDC = $169 million


  1. Clinton physician letterJuly 28, 2015
  2. CDC statisticshttp://www.cdc.gov/ncbddd/dvt/data.html
  3. Simon Noble “Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study” BMJ Open http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987719/
  4. 2008 Surgeon General Call to Action reporthttp://www.ncbi.nlm.nih.gov/books/NBK44178/pdf/Bookshelf_NBK44178.pdf
  5.  Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern.Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501. http://www.ncbi.nlm.nih.gov/pubmed/20331949
  6. Clive Kearon, Natural history of VTE, Circulation http://circ.ahajournals.org/content/107/23_suppl_1/I-22.full
  7. US National Action Plan for Adverse Drug Events, page 50-51, http://www.health.gov/hcq/pdfs/ADE-Action-Plan-Anticoagulants.pdf
  8.  Munir Pirmohamed,  Warfarin:  almost 60 years old and still causing problems. Br J Clin Pharmacol.http://circ.ahajournals.org/content/107/23_suppl_1/I-22.full
  9. Calvin Yeh Evolving use of new oral anticoagulants for treatment of venous thromboembolism Blood Journalhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133479/
  10. Waldron, Psycological impact of VTE,UNC,Clot Connecthttp://professionalsblog.clotconnect.org/2012/02/28/psychological-impact-of-dvt-and-pe/
  11. Beth Waldron, Stephan Moll  A patients guide to recovery after deep vein thrombosis or pulmonary embolism Circulation 2014; 129: e477-e479
  12. http://www.whitehouse.gov/omb/budget
  13. http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2016_CDC_CJ_FINAL.pdf
  14. Radha Krishna Popuri, Suresh Vedantham “  The Role of Thrombolysis in the Clinical Management of Deep Vein Thrombosis ”  Arteriosclerosis, Thrombosis, and Vascular Biology.
    2011; 31: 479-484
  15. Stephan Moll, Beth Waldron “Cerebral and sinus vein thrombosis” Circulation,  2014;130:e68-e70
  16. Selective statistics diminish VTE burden http://bethwaldron.com/selective-statistics-diminish-vte-burden/
  17. Email December 22, 2011 https://wikileaks.org/clinton-emails/emailid/24804
  18. CDC Statistics on DVT/PE (VTE) http://www.cdc.gov/ncbddd/dvt/data.html
  19. 2008 Surgeon General Call to Action reporthttp://www.ncbi.nlm.nih.gov/books/NBK44178/pdf/Bookshelf_NBK44178.pdf
  20. Selective statistics diminish VTE burden http://bethwaldron.com/selective-statistics-diminish-vte-burden/
  21. CDC Data and Statistics, DVT/PE, 12/4/2015 http://www.cdc.gov/ncbddd/dvt/data.html
  22. Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern.Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501.  http://www.ncbi.nlm.nih.gov/pubmed/20331949
  23. AHRQ, Preventing Hospital Associated Vhttp://cpol.army.mil/library/mobil/docs/CEW-Guide-Attach-IX-C.pdfenous Thromboembolism: A Guide for Effective Quality Improvement, October 2015, Publication: 16-0001-EF  http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/vtguide/index.html and Greg Maynard, Venous Thromboembolism (VTE) Prevention in the Hospital (Text Descript: Slide Presentation. June 2010. Agency for Healthcare Research and Quality, Rockville, MD.http://archive.ahrq.gov/professionals/quality-patient-safety/quality-resources/value/vtepresentation/maynardtxt.html
  24.  Berg CJ, Atrash HK, Koonin LM, Tucker M. “Pregnancy-related mortality in the United States 1987-1990”. Obstet Gynecol 1996;88(2):161-7 Also see Marik. P.E. and Plante, L.A. “Venous Thromboembolic Disease and Pregnancy”. New England Journal of Medicine, volume 359, number 19, November 6, 2008, pages 2025-2033
  25. Gross, Scott et al The economic burden of incident venous thromboembolism in the United States: A review of estimated attributable healthcare costs, Thrombosis Research, November 24, 2015,  http://www.thrombosisresearch.com/article/S0049-3848(15)30209-7/abstract
  26. Simon Noble “Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study” BMJ Open http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987719/
  27. CDC FY 2016 budgethttp://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2016_CDC_CJ_FINAL.pdf CDC FY 2017 Request http://www.cdc.gov/budget/fy2017/congressional-justification.htm
  28. Kaiser Family Foundation U.S. Federal Funding for HIV/AIDS: The President’s FY 2016 Budget RequestApr 13, 2015 http://kff.org/global-health-policy/fact-sheet/u-s-federal-funding-for-hivaids-the-presidents-fy-2016-budget-request/#footnote-148589-1
  29. Army policy: http://cpol.army.mil/library/mobil/docs/CEW-Guide-Attach-IX-C.pdf