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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