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.

How one bird improves public health

We love penguins.  We make blockbuster movies about them–Happy Feet, March of the Penguins, Madagascar Penguins, Mr Popper’s Penguins.  And the penguin related merchandise…wow.   But vultures?    Not so much. When a vulture makes an appearance in a movie, they add a sense of foreboding…something bad’s looming about.

Grant it, vultures might not have the cutest face among the birds of the world–put a turkey vulture up beside a barn owl and it’s not a fair match—but I suggest that like so many things in life, you can’t judge a book by its cover.   Today is International Vulture Awareness Day (oh yes, there IS such a thing!)  So indulge me and let me hit you with a few tidbits about these often misunderstood creatures who are an essential part of our ecosystem.

Vultures prevent the spread of disease.
King Vulture..how can you not love this face?

Vultures eat dead stuff.   It’s one reason they get a bad reputation–people find disgusting the notion of eating rotten flesh.  Yet, this act provides a valuable service.  Nature is full of dead animals who succumb to sickness, diseases, accidents, cars, starvation or are the leftover remains of predators.  Vultures are great at sniffing out these dead animals.  And, they get rid of these health hazards for us!

I will not get into a stomach-turning detail of how carcasses rot and attract nasty bacteria and how that makes it way to human populations–just trust me that if you leave enough dead flesh outside long enough, it becomes a catalyst for disease spread.

Vultures excel at gobbling up putrid flesh that would kill any other creature.  Their stomach acid is incredibly corrosive which allows them to safely consume some truly deadly disease-causing organisms like botulism, anthrax, and cholera.

Endangered and essential:  a lesson in what happens without them

Consider a real-life example of what happens when vultures disappear from an ecosystem.  Among the Hindu culture of India, cattle are considered sacred. Of an estimated 500 million cows in India, only 4% are consumed by people.(Ref 1) That means there’s a whole lot of cow carcasses to deal with, around 12 million tons annually.  When cow dies,  it is not consumed by people, but rather by the vultures. They are the waste-disposal system.

The problem for vultures began in the 1990’s when cattle in India began to be widely treated with an anti-inflammatory drug called diclofenac. (This drug is an NSAID and is also used in humans to treat inflammation such as with arthritis) The drug effectively poisoned the vultures who ate the cow’s flesh, causing them to die of kidney failure within hours (Ref 2).  Between 1992 and 2007, the population of one vulture species–the oriental white-rumped vulture–is estimated to have declined by 99.9%. (Ref 3).  Where there were once over 80 million of these vultures, the numbers are now only several thousand–the fastest population collapse of any wild bird in history, including the Dodo.(Ref 4)

What happened when the vultures disappeared and were no longer consuming dead cattle?

  • There was a build-up of carcasses which both contaminated water supplies and harbored diseases like anthrax (3)
  • The disappearance of vultures allowed other scavenger animals to take their place–namely rats and feral dogs. which carried pathogens and therefore spread diseases throughout human populations such as rabies, anthrax and plague.(1)
    • Today in India, there are an estimated 18 million feral dogs, the largest population in the world.  30,000 people die from rabies each year, more than half the world’s total.(1) 70% are children under age 15.

In response to the ‘vulture crisis’, India officially removed the drug diclofenac from market in 2006, but it continues to be available illegally in some areas.  Unfortunately, the damage has been done and it will take some time for the vulture population to rebound, if at all, to levels which will improve public health.

Note that diclofenac continues to be available in the EU and US, however it has not been linked to significant declines in vulture populations in these areas.

Take-away:  we are interconnected

While the lessons of what happened in India with the vulture population has many implications for other countries, the biggest is that it illustrates just how interconnected our ecosystems truly are. What on first glance appears to be an ugly, disgusting, ‘useless’ bird turned out to be an absolutely essential element in public health..and in ways no one would have ever predicted.   So next time you see a vulture by the side of the road enjoying some roadkill, don’t be repulsed. Rather, rejoice in the great service nature has provided–that ugly, bald bird is actually in a very real way out there improving your health!

Tidbits:

There are 23 species of vultures worldwide (14 are considered endangered or threatened). They are found on every continent except Australia & Antarctica.

Vultures are among the longest living birds in the wild–around 30 years.

Vultures mate for life.

They reproduce very slowly–they don’t reach sexual maturity until 5-7 years old and produce 1 chick every 1-2 years.

What’s a group of vultures called?  A committee, venue or volt. In flight, a flock of vultures is a kettle, and when the birds are feeding together at a carcass, the group is called a wake. So many names!

Spooky warning? Nah, they’re just enjoying sunning themselves.

REFERENCES

  1. What is a Vulture Worth?  PBS
  2. The Population Decline of Gyps Vultures in India and Nepal Has Slowed since Veterinary Use of Diclofenac was Banned, Nov 2012, Journal PLOS
  3. The truth about vultures BBC Earth
  4. Conserving South Asia’s Threatened Vultures,Save our Species
  5. BNHS, Société zoologique de Londre, 2007

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.

When the sun doesn’t shine for patients: the glaring loophole in the Sunshine Act

If you or a family member are prescribed a medication, you’d like to think the decision was based solely upon medical evidence that the specific drug chosen was the one which would provide the best health outcome.  So how would you feel knowing this was transpiring behind the scenes among the clinic’s staff:

A1 PhRMA Sunshine Act ACA Obamacare anticoagulant anticoagulants blood thinner

Such activities could easily chip away at any patient’s confidence that the brand drug prescribed to them or a family member was based upon clinical evidence alone.

Lest you think this is an isolated incident, keep reading.

If you’re saying right now ‘but aren’t there rules to prevent drug companies from influencing physician decisions?’  Yes, there are but as with any rule there are creative ways around them.  I’ll get into those in detail shortly, but first you need to understand a bit of background about the drugs in question.


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 Anticoagulants:  life-saving yet dangerous

The drugs referenced in the exchanges cited are anticoagulants (commonly called ‘blood thinners’).  Anticoagulants are used to treat and prevent blood clots in around 4 million American patients each year with thromboembolic disorders, such as atrial fibrillation and venous thromboembolism. (Ref 1) The majority of anticoagulant patients are over age 65.(8)

There is good reason to take special care during the prescribing and management of these drugs: anticoagulants are the most common medication to cause adverse drug events, with bleeding being the most common side-effect.(2)  Ten percent of all drug-related adverse outcomes are from anticoagulants.(1) Why? Anticoagulants are finicky medications to manage—too little drug in the body can cause clotting while too much can cause bleeding and both these extremes bring potentially fatal consequences.(1)

Such bleeding and clotting risks are influenced by a multitude of factors, such as age, co-morbidities, concomitant medications, and even diet and pharmacogenetics.(1) For these reasons,  a one size fits all approach to anticoagulation management isn’t applicable; rather, an individualized approach to patient care must be taken to determine which drug to use, at what dose and for how long.

As evidence of just how difficult it can be to manage anticoagulants, consider that 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.(1)  In one study of Medicare beneficiaries, anticoagulants accounted for one-third of all adverse drug events in the hospital, a place with the closest medication supervision of any setting. (Ref 1).

When it comes to anticoagulants, there are currently multiple choices–five FDA approved oral anticoagulants are on the US market.  It wasn’t always this way.  For over 50 years, there was only one oral drug–Coumadin® (warfarin).  Since 2010, four additional oral anticoagulants have been FDA approved:  Pradaxa® (dabigatran), Xarelto® (rivaroxaban), Eliquis® (apixaban) and Savaysa®(edoxaban). While each drug is used for the same indication–in the treatment and prevention of clots–they are also different with varying pharmodynamics, ease of use, frequency, side-effects, contraindications and timing (ie whether an injectible anticoagulant must be given during the acute clot time period prior to start).  Each has unique advantages and disadvantages and it is appreciating these differences which further leads to complexity in anticoagulation management.  With greater choice comes the greater potential for errors to occur, thus necessitating increased education and vigilance.

To sum a key-point:  optimal anticoagulation management depends heavily on an individualized approach to prevent potentially life-threatening side-effects. 


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Sunshine Act and the health professional/pharma relationship

With five oral anticoagulants available, there is fierce competition among the various manufactures to claim a share of the $5 billion a year US market.  To illustrate the level of competition, consider that three of these anticoagulant makers spent $19.4 million on physicians and teaching hospitals during just the last 5 months 2013, reflecting the most recent federal data available.(3)

Payments and gifts valued at over $10 are regulated as of  August 1, 2013 under the Physician Payments Sunshine Act, a part of the Affordable Care Act which requires manufacturers of drugs, medical devices, and biologicals that participate in  federal health care programs (such as Medicare) to report certain payments and items of value given to US physicians and teaching hospitals.

The Sunshine Act defines a “physician” as any of the following types of professionals who are legally authorized to practice(6):

Doctor of Medicine
Doctor of Osteopathy
Doctor of Dentistry
Doctor of Dental Surgery
Doctor of Podiatry
Doctor of Optometry
Doctor of Chiropractic Medicine

Note that this list does not include all health professionals with prescribing ability.  While payments and gifts to physicians must be disclosed, there are no requirements to report payments and gifts to persons who work closely with physicians such as nurses, medical assistants and office staff. Health professionals who often manage anticoagulation such as Doctors of Pharmacy (PharmD), Nurse Practitioners (NP) and Physician Assistants (PA) also do not fall under the Sunshine Act provisions.  While these persons are not physicians, they do have prescribing ability in most states.(4) Nurse practitioners and physician assistants write about 15% of all prescriptions.(4) These persons are allowed to receive payments and gifts from anticoagulant makers and those are not required to be attributed to the physician they are affiliated with.

These payments are off the radar–a concern because both the NPs and PAs who do have prescribing ability (as well as the RNs and nurse assistants who don’t), all have direct care contact with patients in which they can mention specific products. All have close working relationships with physicians.  Their viewpoints can potentially influence prescribing practice on both the patient and physician side of the shared decision making model.

Going back to the first example above, this person is not a physician.  Further public statements reveal him to be a pre-med student working as a medical assistant in a facility that cares for a high degree of frail, elderly persons (ie persons statistically most likely to be on anticoagulants.)  I must admit that trying to influence the opinions of future doctors is a new tactic I had not yet seen.  It is also does not appear to be an isolated, one-time event, according to social media posts where I found  ample examples of medical, pharmacy and nursing students citing drug company hospitality.


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Industry attempts to self-police

To stave off federal rules in its relationship with medical professionals, the pharmaceutical industry’s trade group Pharmaceutical Research and Manufacturers of America  (PhRMA) first embraced voluntary guidelines in 2002 which prohibit the very type of enticement gifting I’ve cited.  Under the current PhRMA Code of Interactions with Health Care Professionals issued in 2008, enforcement falls to each pharmaceutical company to “adopt procedures to assure adherence”.(7) Companies who choose to accept the voluntary code of conduct have an annual survey in which they certify they have “policies and procedures in place to foster compliance with the Code”.(7)  In other words, companies are entirely self-policing their interactions with health professionals.  It is akin to the fox guarding the henhouse and it clearly isn’t working.

What does this mean?  My bias disclosure, needed steps

I bring this activity to light because I think informed patients make better decisions.  We have a right to know the factors which impact our care.  I fully realize that healthcare is a business and businesses must make a profit.  I am not anti-pharma nor am I against physicians taking pharma funds.  Rather, I am for greater transparency and disclosure.

If an anticoagulated elderly family member is in a nursing facility and the medical assistant tells her about a great drug and encourages her to ask the doctor about it,  I’d like to know if that person received pro baseball tickets and a parking pass to do that.  I’d also like to know if that person gave any of those tickets to the physician who oversees his/her work.  The rules exempting staff from reporting creates a very easy mechanism whereby the physician’s staff can serve as legal 3rd party pass-thru for pharma gifting.

Let me be clear:  I am in no way suggesting that all health professionals are influenced by pharma contact.  But those of us who work closely in healthcare have to admit that influence does happen.

I’ve worked in and around the healthcare field for some 24 years; the last 12 I have been taking an anticoagulant myself.   Have I eaten free meals provided by pharma while attending meetings?   Yes, and it was nearly every time quite delicious.  Have I accepted pharma funds?  Yes.  Programs I worked with and/or volunteered with received educational grants and donations from pharma. As for personal payments, a company paid my expenses to travel and speak at a conference they hosted—one time.    Will I do it again?   No.  That is a promise.  What I have learned along the way, not only from personal experience but from observing those around me who try to be self-policing,  is that even if you tell yourself ‘I’ll take XYZ because it’s being offered but it won’t influence my behavior, I’m my own independent person, etc’ you are still on a level compromised.  Rarely in life do you get something for nothing.  Even when it is stated that ‘no strings are attached’, there often are.  It is simply human nature to not bite the hand that feeds you.

What I’d like to see:

  • Eliminate the $10 minimum threshold for Sunshine Act reporting.  The value of a gift is irrelevant to the degree of face-time and influence it provided.  If a physician receives a pumpkin spice latte and a ham biscuit, we should know.
  • Expand reporting to include all prescribing clinicians–nurse practitioners, medical assistants, etc
  • Prohibit payments and gifts to any staff employed by a medical practice or their family members—nurses and office staff too. No free meals, tickets or gifts–nothing, period. Offices can go get their own pens at Staples.
  • Prohibit contact of medical students by pharma, both on campus and off.  Any education about a drug that an aspiring doctor, nurse or pharmacist needs while in school should come first from their professor, not from a company sales rep. Past study has shown that half of all medical students have received gifts from pharma, often off campus where they are outside institutional control.(5)
  • All health professionals should publicly post a Conflict of Interest statement–website, waiting room wall, wherever–disclosing their relationships with pharma including consulting, speaking,clinical trials, etc.  At present, a patient can go (at great labor) and research those relationships and depending if the practitioner is a MD, RN, NP, etc they’ll find a wide range of professional society and state reporting standards. They may or may not find any information.  When clinicians publish, serve on a board or guideline panel or other such professional activity they often must make COI disclosure.  A COI is a routine, accepted practice in these settings.  Why not do this in a standardized format for patients as well?

Do I expect these things to happen?  Not really, but I’d like to see the discussion about greater transparency started.  I’ve heard the position that pharma reps provide an invaluable service to clinicians by educating them on new drugs.  Yet, consider what actions would promote evidence-based medicine.  Industry can provide clinicians with documentation about their product—brochures, clinical trial data, research publications–all would demonstrate in a more objective manner why their product is 1) safe 2) effective and 3) better than the competitive alternatives.  Or they can educate clinicians by plying the office staff with lattes and hockey tickets.   Not a tough call here.

How exactly does providing sporting tickets to the physician’s assistant improve patient safety or lead to better health outcomes?  It doesn’t.  At best, it simply creates good will among the persons who surround the physician (and thus who may put in a good word) or at worst, it is the direct manipulation of prescribing practice.

So much money goes towards marketing drugs that it also needs to be considered how much this gifting adds to the drug’s retail price.  The newer anticoagulants are fairly expensive and do not have generic equivalents.  I am very grateful for these drugs…they are life-saving and quality-of-life altering. Yet, when I see the marketing budgets and hear the stories from patients who cannot afford their medication, it makes me rather uneasy.  It makes me wonder if there isn’t a better way to educate health professionals, their staff as well as patients about potential therapies.


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If references cited are not enough and as I know this will be asked….here are my credentials on this topic, with links to cross-reference to confirm:

I am a venous thromboembolism (VTE) survivor on long-term anticoagulation therapy.  I am the founder and former director of a  VTE education program at the University of North Carolina in Chapel Hill. I have published on the VTE patient experience including anticoagulation options in peer-reviewed medical journals. I have also given speeches on ‘VTE from the patient perspective’ to government agencies and industry and served on CDC and CMS workgroups, including reducing anticoagulation harm as anticoagulants are a top cause of adverse drug events in the US. Most recently I have been invited by the American Society of Hematology to serve as a patient representative on a ASH Guideline Panel on Thrombophilia to assist in the development of evidence based clinical practice guidelines on VTE.  I have been called by CMS “a leading national patient advocate for action and progress on VTE”.

Good enough to have a reasoned opinion?

REFERENCES

  1. HHS National Action Plan for Adverse Drug Events, 2014 http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf 
  2. Piazza G, Nguyen TN, Cios D, et al. Anticoagulation-associated adverse drug events. The American journal of medicine. 2011;124(12):1136-1142.
  3. Charles Ornstein,Ryann Grochowski Jones Vying for market Share, Companies heavily promote ‘me too’ drugs, ProPublica January 9, 2015
  4. Charles Ornstein, Industry Payments To Nurses Go Unreported In Federal Database, NPR July 6, 2015
  5. Pauline Chen MD, For med students, love from drug reps , New York Times October 3, 2013
  6. CMS Fact Sheet for Physicians on the Sunshine Act
  7. Pharmaceutical Research and Manufacturers of America  Code on Interactions with Health Professionals 
  8. 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
  9. Note:  All above Twitter post screen grabs occurred on 9/10/2015

And going on the world beyond anticoagulant specific mentions…..

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