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.

Women and Venous Blood Clots: Life saving information on International Women’s Day

Today is International Women’s Day.  One way to honor women is to share life-saving knowledge.  So let’s talk about venous blood clots because far too many women do not realize they are uniquely at risk for developing this common, potentially life-threatening condition.

What is it?

Venous thromboembolism (VTE) is a blood clot which forms in a deep vein of the body. It may go by several names depending on the physical 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)

Each year, 10 million people worldwide experience venous thromboembolism (VTE). It is a leading cause of death and disability in both low-income and high-income countries. (7)

  • In the United State alone, deaths from venous thromboembolism (VTE) are greater than those of AIDS, breast cancer, and crashes combined.
  • In Europe, VTE causes half a million deaths annually.

Effective prevention strategies exist. Yet studies show few people worldwide even know what VTE is or how it can be prevented.

How do they impact women?

While venous blood clots affect both men and women, there are unique considerations for women:

  • Blood clots can be life-threatening during pregnancy and are the leading cause of maternal death in the United States. (1)
  • A woman is at increased risk for developing blood clots during pregnancy and that risk remains elevated for up to six-weeks following childbirth.  Pregnancy increases the risk of a blood clot fivefold, with the risk even higher in the postpartum time period. (2)
  • Post-menopausal women undergoing hormone replacement therapy have a two to four fold increase in the risk for clots. (3)
  • Women with a clotting disorder (thrombophilia) have increased clot risk.  About 8% of the US population is estimated to have a clotting disorder and a clotting disorder is found in upwards of 50% of women who have a blood clot during pregnancy.
  • Women with a clotting disorder experience a higher rate of pregnancy complications including repeated miscarriage or stillbirth.(4)
  • Estrogen containing oral contraceptives increase clot risk.  Some contraceptives significantly increased risk more than others, 2-3x more.   More information on specific contraceptives and clot risk. (5)
  • Cancer patients are at increased venous clot risk.  Cancer, chemotherapy and surgery can each increase clot risk.  Women treated with tamoxifen to prevent or treat breast cancer are also at increased risk. (6)
What can you do?

Educate yourself and then pass along what you’ve learned to those persons closest to you. If you’ve been impacted by blood clots, share your story. Silence about venous blood clot risk helps no one. If we wish to save lives, we first must talk openly about it.

Above all, know the symptoms, risk factors and prevention strategies for the most common form of venous blood clots, deep vein thrombosis and pulmonary embolism.

How can you learn more?

For more information about clotting concerns unique to women:

Women and blood clots – from the National Blood Clot Alliance and the Rowan Foundation

Thrombophilia and pregnancy – from the March of Dimes

Contraceptives and blood clots – From the University of North Carolina’s Clot Connect campaign

Pregnancy and blood clots – from Duke University’s This is Serious campaign

Cancer and blood clots – from Duke University’s This is Serious campaign

Clinical practice bulletins and guidelines:

ACCP:   VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Bates et al  Chest. 2012;141(2_suppl):e691S-e736S

ACOG:  Practice Bulletin 123:  Thromboembolism in Pregnancy Guidelines from the American College of Obstetricians and Gynecologists regarding the prevention, management and treatment of blood clots during pregnancy.  Obstetrics & Gynecology. 118(3):718-729, September 2011.  Note: journal license required to view full article

ACOG: Practice Bulletin 124:  Inherited thrombophilias in Pregnancy  Review of common thrombophilias and their association with maternal venous thromboembolism risk, adverse pregnancy outcomes, indications for screening to detect these conditions and management options during pregnancy. Obstetrics & Gynecology. 118(3):730-740, September 2011.  Note: journal license required to view full article. 

REFERENCES

1. 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.

2.Heit JA, Kobbervig CE, James AH, Petterson TM,Bailey KR, Melton LJ, 3rd. Trends in the incidenceof venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med 2005;143(10):697-706

3. Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism US Department of Health and Human Services 2008

4.  March of Dimes

5. http://www.clotconnect.org/patients/what-do-i-need-to-know/i-m-a-woman-on-contraceptives

6. NBCA, Cancer and Blood Clots,  https://www.stoptheclot.org/faq_blood_clots_cancer.htm

7. Thrombosis:  a major contributor to the global disease burden.  Journal of Thrombosis and Haemostatis, 12: 1580-1590 Oct 2014

 

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:

immigration-table-4

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

 

bw-tag-4

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’:
cdc-def-1

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-heart

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.

cdc-monthly

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-fy2017-blood-disorders

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.

Reference

  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.
POST UPDATE:

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.”

Yikes!

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.

Blog in transition…new content coming

I’m currently transferring the site to a new host & moving over select past content. Apologies for any broken links in the interim. …expect new content soon.

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

One Presidential candidate has a history of venous thromboembolims (VTE). How relevant is that to the campaign and have past Presidents had this condition?

Blood clot facts show need for greater advocacy

It’s the most common, deadly preventable condition which is totally ignored.

Coumadin from Canada: the dark side of internet medicine

Like 4 million Americans, I take an anticoagulant drug, also known as a ‘blood thinner’. Anticoagulants are used to treat and prevent blood clots in patients with thromboembolic disorders, such as atrial fibrillation and venous thromboembolism (VTE).

They’re also very dangerous drugs.  Anticoagulants are the most common medication to cause adverse drug events, with bleeding being the most common side-effect.(Ref 1)  Ten percent of all drug-related adverse outcomes are from anticoagulants and they are the most frequently implicated drug in adverse events resulting in emergency room visits and hospitalization with the resulting costs running into the hundreds of millions of dollars.(2)  Anticoagulants are not a drug to be dispensed without thought and oversight.

I started anticoagulation therapy 13 years ago, when I was 34 years old, following an episode of deep vein thrombosis and pulmonary embolism.  I’m a rarity however…the majority of anticoagulant patients are over age 65. (Ref 3)  While I’m fortunate to have prescription drug insurance, many do not. Even with prescription drug coverage, medications can still be unaffordable. Approximately 1 in 5 people don’t take a medication a doctor has prescribed because they can’t afford to pay for it. (4)  So it’s no wonder that patients, especially older patients on fixed incomes, are tempted to seek out cheaper sources of prescription drugs. It is a question I’m often asked…how do I afford my medication?  I did some research to see what resources were available to patients like myself on anticoagulants.  What I found was alarming.

A search quickly led me to the account of Dr. Frank Evans (@frankevans111) who has over 109,000 Twitter followers.  Dr Evans promotes many drugs, all linking to a Canadian pharmacy. One of the drugs he promotes is Coumadin (warfarin), a prescription anticoagulant.

CanPharm

The Canadian pharmacy

When I followed the link to the Canadian website, I was easily able to place an order for Coumadin.  No prescription required to be presented.  No medical questions of any kind asked.

I was even offered a bonus FREE medication to go with my Coumadin purchase…my choice of 4 pills of Viagra or Cialis.  How thoughtful, freebies. Screenshot of my cart:

CanPharmCart

But don’t worry…being a savvy consumer, I see this is clearly a legitimate pharmacy as none other than the US Department of Health and Human Services and Better Business Bureau logos are featured along the bottom of each page:

canpharmlogos

When I click on the HHS logo, this ‘official’ HHS certificate pops up to reassure me:

canpharmseal

 

There is even a handy link to their Canadian pharmacy license:

canpharmcert

Of course, none of these documents are legitimate.  HHS does not issue such certificates.  Even the license number isn’t found in the Ontario College of Pharmacists registry.

Yet it certainly looks impressive.  Least you laugh and think ‘who on earth would think such a site is legitimate?’, keep in mind only 12% of US adults have proficient health literacy. Many patients lack the skills needed to vet health information, making them easier health scam targets.

A doctor promoting online drugs?  Maybe, maybe not.

canpharmdoc1I found myself wondering…what kind of medical doctor encourages people to get a dangerous drug online from a clearly questionable pharmacy?  It is near-to-impossible to determine the true identity of a Twitter account or their true location, NSA types not-withstanding perhaps.  Dr. Evans Twitter profile lists his location as Los Angeles, California, which may or may not be accurate. I checked theMedical Board of California database and found that indeed, a Frank Evans is currently licensed to practice by the state of California.  And that this licensed Frank Evans is from Canada and he once held a fellowship in addiction medicine at Loma Linda University, which it not too far from Los Angeles.  But there is absolutely no evidence beyond these coincidences to suggest that they are one and the same person. Because this internet pharmacy is utilizing the same name of a real, licensed physician,  any basic online verification of credentials by a patient may lead to the false assumption that they are connecting with a reputable clinician.

Is there a real Dr. Evans behind this twitter account? Probably not. Surely someone would not be so naive as to use his or her real name when perpetrating a scam.  The headshot photo of Dr. Evans on the Twitter feed appears to be a generic stock photo; it shows up as in marketing uses on multiple websites, across a range of medical products.

All that glitters

canpharmbill

My receipt for coumadin from internet pharmacy

The question remains:  Why would a patient buy Coumadin (wafarin) over the internet?

Cost?   It can’t be cost.   While there is the perception that Canadian drugs are cheaper than in the United States, this is not always the case. Generic Coumain, warfarin, is actually cheaper if purchased from your corner pharmacy in the US than from this Canadian pharmacy.

2 mg warfarin 30 tabs at Wal-Mart = $4.

2 mg warfarin 30 tabs from Canadian Pharmacy = $38.55

Convenience?  It can’t be convenience.  If you are a patient on Coumadin (warfarin), obtaining a prescription is easy. This is a medication which requires very close management…necessitating an office visit to check optimal blood thinning levels (INR), on average, once per month with more frequent visits sometimes required.  The clinician managing a patient’s INR is also likely the one writing the scripts.  There should never be a time in which a patient is not under the care of a clinician to be able to access a new script.

Illicit use?  When you order online and a prescription is not required to be presented, it leaves the door wide open for people who don’t really need a drug to gain access.  What is the benefit of this for Coumadin?  To my knowledge there is no reason for anyone to take an anticoagulant if they don’t need to.  You can’t get high from it.  There is no resale value. This is such a dangerous drug that there is only potential harm from taking it…and therein is a disturbing possibility, that it could be utilized for self-harm. On websites which provide guidance for those contemplating suicide, Coumadin is mentioned by name with suggested dosing to ensure a fatal result. (I will not link to this material)

While I can’t fathom why patients would order anticoagulants over the internet, it surely must be happening by enough people;  if there wasn’t a profitable market, then online pharmacies would not do it.

Beyond one pharmacy and Coumadin

xareltoMultiple anticoagulants can be purchased on the internet, not just Coumadin (warfarin).  I found multiple internet pharmacies willing to sell the newer (and far more expensive) anticoagulants where no generic is yet available–Pradaxa, Xarelto, Eliquis, Savaysa.  In some cases, an internet pharmacy will advertise one of the newer drugs and then redirect the consumer to a ‘better, cheaper alternative’ to purchase warfarin.  One can only hope that patients understand that anticoagulant drugs have very different dosing and management and are not self-interchangable. You cannot sub out 10mg of one Xarelto for 10mg of warfarin and all will be fine!pradaxa

The lesson

My takeaway from this research:

  1. It pays to do your homework.  Something advertised as ‘cheaper’ isn’t always. Nor is it equally safe and effective..you have no way of knowing what you’re truly getting in the mail from a source you don’t know personally. If at all possible, deal with your local pharmacy where you can talk to someone with known expertise, face-to-face. If you can’t afford your medications, talk to your pharmacist and physician who can help identify appropriate cheaper alternatives, coupons, and patient assistance programs.
  2. Just because someone has ‘MD’ behind their name, it unfortunately doesn’t mean they are a reputable source of information. Nor does it mean they actual possess the credentials they claim.  Be skeptical.  Give special scrutiny to anyone online using their credentials as a method of trying to sell you something.
  3.  Despite efforts. the ability of regulators to close down illegal pharmacies is limited. The ‘Frank Evans MD’ Twitter account first began sending people to this particular Canadian pharmacy in March 2015, so I presume this domain/pharmacy has been in business at least since that time…long enough that its surprising its still operating. Regulation can only do so much; the best protection is to be an informed consumer and take the advice of the FDA:  “Don’t order medicines from web sites that claim to be Canadian pharmacies. Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.”

 

REFERENCES

  1. Piazza G, Nguyen TN, Cios D, et al. Anticoagulation-associated adverse drug events. The American journal of medicine. 2011;124(12):1136-1142.
  2. HHS National Action Plan for Adverse Drug Events, 2014 http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf
  3. Kirley et al National Trends in Oral Anticoagulant Use in the United States, 2007 to 2011 Circulation: Cardiovascular Quality and Outcomes. 2012; 5: 615-621
  4. Mazer, M., Bisgaier, J., Dailey, E., Srivastava, K., McDermoth, M., Datner, E. and Rhodes, K. V. (2011), Risk for Cost-related Medication Nonadherence Among Emergency Department Patients. Academic Emergency Medicine, 18: 267–272.

Fighting for Blood Clot Patients?

HRC Durham

Hillary Clinton, Durham NC 3/10/2016

I want to like Hillary Clinton.  I do. I’d love to see a female president one day. It’s just that every time I see and hear the Hillary Clinton campaign slogan “Fighting for Us”, I can’t help but think of the one population Clinton is not fighting for:   her fellow patients at risk for venous blood clots, medically known as venous thromboembolism (VTE).(definition at end)

VTE can happen to anyone, at any age—from healthy athletes and pregnant women to cancer patients and the elderly. It happened to me at age 34, my father at age 77 and it happens to nearly 900,000 Americans every year.  Clinton is also one of us, having been stricken with three VTE clotting eventswithin the past 13 years–deep vein thrombosis in 1998 and again in 2009 and transverse sinus vein thrombosis in 2012.

The good news is that most VTE and their complications are preventable—effective prevention, diagnostic and treatment strategies exist.

The bad news is there is no coordinated federal effort to push this life-saving educational information out into the hands of patients and clinicians where it can be actionable.

Unfunded prevention

President Obama’s FY 2017 Budget Proposal reflects national priorities of $4.1 trillion in federal spending.  Absent from the budget:  line-item funding for the #3 overall cause of death in the US and the #1 cause of preventable hospital death, VTE.

For perspective, VTE kills more Americans annually than breast cancer, AIDS and motor vehicle accidents combined—issues which receive targeted federal funding to address.  It even kills more than firearm homicides—something we hear far much more often about from both candidates and the media.

The CDC is the federal agency responsible for protecting the public’s health through the prevention of disease. While 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.

“A major health problem”

More shocking when you realize the government itself has said VTE needs to be targeted. Because most VTE are preventable and it is a problem projected to worsen as the population ages, it has been identified as a national health priority by the Surgeon General’s 2008 Call to Action, the CDC, the CMS Partnership for Patients and Healthy People 2020. The 2008 Surgeon General Call to Action report sounded the loudest alarm on VTE, calling it as “a major health problem, exacting a significant human and economic toll on the Nation” and acknowledging that “there are few public health problems as serious.”

Yet no direct line-item funding allocation specifically for VTE has been made to support these designations.  It is a public health priority in name-only–a preventable, potentially life-threatening public health issue which lacks both attention and government funding to adequately address.

Clinton Silence

Clinton could have played a key role in changing that.  Clinton’s first clot occurred 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 visibility and policy influence.  If at any of those junctures, she had stepped up to share her clotting experience, taken-up clot advocacy or encouraged Congress or the President to increase dedicated funding, millions of lives could have potentially been saved or at the very least, positively impacted.

She didn’t. To this day, Clinton has not spoken publicly about her thrombotic experience nor engaged those of us in the VTE patient community.

Avoiding the ‘clot’ word

Worse still, there seems to be a concerted effort by those closest to her campaign to NOT address blood clots.  Her spouse, former President Bill Clinton, has given four paid speeches to the Patient Safety Movement Foundation’s annual conference whose mission is to address sources of preventable hospital death.  The most common cause of preventable hospital death is VTE clots, according to Agency for Healthcare Research and Quality (AHRQ).  Yet oddly, rather than bring attention to VTE in his $315,000 fee talks (according to a financial disclosure statement filed by Hillary Clinton and the PSM Foundation’s IRS 990 tax filing), Bill Clinton chose to recount the medical story of a cousin with sepsis and never once mentioned his wife’s three-time VTE experience.

What is troubling to me as an advocate, is why the continued cone of silence on blood clots from both Clintons?  Given both the personal impact and their influential positions, both Clintons should be speaking out–without the auspices of a paid speech–for greater blood clot awareness and funding.  I’m not sure from the campaign rhetoric who Hillary Clinton is fighting for, but past experience shows clearly it is not for blood clot patients like myself.


About VTE

What is VTE?

Venous thromboembolism (VTE) is the medical term for a blood clot occurring a deep vein of the body. Depending on the location (leg, arm, lung, abdomen, brain), VTE may be referenced by multiple names such as: deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis, splenic vein thrombosis, mesenteric vein thrombosis, renal vein thrombosis, sinus vein thrombosis, cerebral vein thrombosis–all are under the VTE umbrella.

Public health scope of VTE

“Deep Vein Thrombosis and Pulmonary Embolism (DVT/PE) represent a major public health problem, exacting a significant human and economic toll on the Nation.”-US Surgeon General 2008 Call to Action

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.[1],[2]
  • 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.[3]
  • Upwards of a third of VTE patients die within one month of diagnosis.[4]
  • 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.[5]
  • VTE is the leading cause of preventable hospital deaths in the United States. ~60% of VTE are associated with hospitalization.[6]
  • VTE is the leading cause of maternal death in the United States.[7]
  • An estimated $7-12 billion in medical costs in the US each year can be attributed to DVT and PE.[8]
  • High levels of anxiety, depression and psychological stress have been reported among patients with VTE.[9]

Funding

By comparison to other better known conditions:

  • AIDS funding = $31.7 billion[11], CDC portion of AIDS funding = $927.8 million10
  • Breast & cervical cancer funding (in 1 combined line-item), CDC = $169 million

Learn more


My Suggestions on Federal Action Needed to Change These Statistics

To 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.
  3. 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.
  4. Require HHS/CDC to update the National Vital Statistics reporting to add VTE to the current list of 113 select causes of death.  Neither the public nor Congress can be aware of the true scope of a condition which is not reported.

REFERENCES

[1] CDC Statistics on DVT/PE (VTE) http://www.cdc.gov/ncbddd/dvt/data.html

[2] 2008 Surgeon General Call to Action reporthttp://www.ncbi.nlm.nih.gov/books/NBK44178/pdf/Bookshelf_NBK44178.pdf

[3] Selective statistics diminish VTE burden https://bethwaldron.com/selective-statistics-diminish-vte-burden/

[4] CDC Data and Statistics, DVT/PE, 12/4/2015 http://www.cdc.gov/ncbddd/dvt/data.html

[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] AHRQ, Preventing Hospital Associated Venous 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

[7] 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.

[8] 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

[9] Simon Noble “Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study” BMJ Open http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987719/

[10] 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.html

[11] Kaiser Family Foundation U.S. Federal Funding for HIV/AIDS: The President’s FY 2016 Budget Request

Apr 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

Budget fails patients

How the #1 cause of hospital patient death & #1 cause of maternal death in the US gets $0 funding in the federal budget.

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