Direct-To-Consumer Genetic Tests: Who Are They REALLY Benefitting?

The FDA approved the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants), the first direct-to-consumer BRCA test by 23andMe that may be performed in the comfort of one’s home without the need for a prescription. Press releases and even the FDA announcement do not thoroughly detail the many limitations and conditions associated with the test. Individuals many incorrectly interpret what the test’s results may show or may over-extrapolate how the test is meant to be used. In healthcare, it is of essence to be considerate of people’s health literacy levels so as to encourage informed decision-making based on factual, credible information. It’s also important to be fully transparent as to how the test’s results are benefitting the actual company, in this case 23andMe, as well as other third party companies. This needs to be spelled out front and center. Not just buried in the legalese of the terms and conditions and privacy policy.

Here are the limitations, caveats, and fine print that everyone needs to know about regarding the latest FDA approved 23andMe offering:

  1. The test only detects 3 out of more than 1000 BRCA mutations. BRCA1/BRCA2 breast cancer gene mutations are most common in Ashkenazi Jewish populations. This test does not benefit the general population.
  2. A negative result does NOT rule out the possibility of other BRCA mutations which may pose an increased risk in cancer.
  3. Not all cancers are BRCA mutation driven or hereditary. Some cancers develop sporadically. A negative result does NOT mean one has no risk for developing cancer.
  4. People who test positive should seek the guidance of a medical professional and understand that they will most likely be retested in a supervised, clinical setting.
  5. A positive test result may lead to fear, anxiety, and distress.
  6. Patients and clinicians should NOT make medical decisions, such as opting for prophylactic surgery or anti-hormone therapy, based on 23andMe test results.
  7. This test is NOT a substitute for consulting with your doctor for cancer screenings, genetic counseling, or managing lifestyle factors that may impact one’s cancer risk.
  8. Anyone with a strong family history of cancer should seek professional medical guidance for appropriate management.
  9. Your web behavioral, genetic, or self-reported information may be used by the company internally to improve their services or sold to third party companies for research, marketing and advertising, or commercial purposes. Read the privacy policy and the terms and conditions.

The test may only benefit a very small population of people, specifically those of Ashkenazi Jewish descent, however it is being marketed and offered to the general public. People will purchase the test for a variety of reasons. Regardless of what their reasons are, who the test benefits (or doesn’t), all of the people who submit their saliva samples for testing will have their data and results utilized in one way or another or sold to third party vendors for commercial purposes. Any improvements in company services, commercial, or research advancements that happen as a consequence of using customer data offers zero recognition or compensation for their “participation”. In the end, who really gets the most benefit?

Pharma's 50 Shades of Gray: Including Patients in the Clinical Trial Life Cycle

“Is there a form I could fill out to provide my feedback?”

The silence in the room was deafening.

I exhaled with a furrowed brow, feeling extremely disappointed, wanting to stand up and apologize on behalf of the entire room that was seated so quietly. Apologize for the practices, procedures, and ideologies that had failed this woman panelist on stage, and so many others. Apologize on behalf of an industry that is advancing on so many levels, yet dropping the ball in too many priceless ways.

“Is there a form I could fill out to provide my feedback?”.

This simple question came from a vibrant young woman who just delivered a powerful narrative that brought a quiet room to a roar with the applause of a standing ovation.  This young woman detailed her harrowing patient experience of dying of advanced cancer to a tremendous success story reveling in the miraculous power of personalized medicine. She is years post the clinical trial that saved her life.

“Is there a form I could fill out to provide my feedback?”.

If she hadn’t stood at the podium and told us her story, no one would’ve known the horrors she witnessed, felt, experienced, or thought. If she hadn’t stood on the stage and articulated her story, no one would have known about her difficulties of finding the trial that saved her life. Without her story, no one would’ve heard her suggestions for improvement. If she just sat in her seat like every other member of the audience, no one would’ve known how scary, how exhausting, and how painful her journey was. Thank goodness she was invited to share her story! Otherwise, she’d just be another anonymous clinical trial endpoint successfully met.

It’s gravely concerning that after participating in a successful trial, no one invited her to help improve the process. If an educated, well-spoken, personable individual with a miraculous response to a cutting-edge therapy isn’t included in the enhancement, refinement, and co-design of clinical trials, who will be?

It’s common to hear from patients that they are not asked for their insights during or after participation in clinical trials. There is an aura of reverence surrounding people who have participated in trials. These individuals have made a profound sacrifice and leap of faith. Trial participants have agreed to introduce a foreign substance, a hypothesis, into their body, realizing that this unknown may save their life, end it, or run the gamut of all of the possibilities in between.

Imagine being diagnosed with terminal cancer, being sent home to die. Shattered. In physical, mental, and spiritual pain. Would you risk trusting an unknown therapy and introducing it into your frail, already dying body? Could you picture yourself taking an experimental agent and hoping for the best? How many of us are truly brave enough to put our trust and fate into the hands of science? Wouldn’t you agree that these experiences are profound, rare, and worth their weight in gold to thoroughly comprehend?

There are over 21,000 clinical trials listed in as recruiting in the US.  Were these trials designed to be tailored to the lives of the people living with a diagnosis and inclusive of all lives with a diagnosis? It depends on whether the expertise of patients and carepartners were included throughout the continuum of the clinical trial life cycle.

Over the last year, it’s been my personal curiosity to ask members of pharma if their company includes patients in the clinical trial life cycle. When I broach the subject, there is a broad spectrum of reactions, the majority of which are accompanied by clear discomfort, agitation, defensiveness, dismay, and confusion. These responses all fall into an ambiguous gray area. Here are 50 answers I have received in response to the question: Does your company include patients’ expertise and insights in the clinical trial life cycle, from study design planning, during trial implementation, after trial closeout, and post-launch of product?

1.     There are compliance issues.

2.     There are regulatory hurdles.

3.     What business incentive is there to do that?

4.     Patients don’t know anything about clinical trial design, management, or operations.

5.     We don’t have a budget for that!

6.     The FDA doesn’t require patient feedback or insights in the clinical trial process for drug approval.

7.     (Look of confusion)

8.     Our company is patient-centered. We don’t need patient insights.

9.     We don’t have the staffing to do that.

10. Pharma doesn’t traditionally speak with patients.

11. Our stringent timelines cannot accommodate this.

12. Where would we find patients to participate?

13. (eyes narrowing) Are you one of those patient activists?

14. Patients aren’t well spoken.

15. Patients aren’t professional enough to participate in these conversations

16. Our legal team would go into cardiac arrest.

17. We do not have the technology in place to do this.

18. It sounds like a great idea but upper management would never approve.

19. Our marketing team is working on a campaign.

20. We only work with non-profits.

21. It’s on the backburner for this fiscal year.

22. This is a conflict of interest.

23. We’re one of the top biopharmaceutical companies in the industry. We know what we are doing.

24. Do you know how much it costs to execute a clinical trial?

25. (eye roll)

26. Our clinical operations team runs like a well-oiled machine.

27. Do you have any references or data to support the benefit of including patients in clinical trial design?

28. Patients are unreliable and volatile.

29. That’s a waste of time.

30. Working with patients is a pain in the @ss.

31. How could pharma work with patients? They don’t trust us!

32. Sounds great in an ideal world, but we have pressing deadlines to meet.

33. Patients have their own agenda and won’t collaborate.

34. We can’t base our clinical trials on patient complaints.

35. Our company runs successful trials and gets approvals without patients involved in the process.

36. That’s another trend that will phase out soon.

37. Whose responsibility would that even fall under at our company?

38. We are watching to see how other companies are doing it.

39. Those tactics are for companies that can afford the “bells and whistles”.

40. We tried. It didn’t work.

41. We are too small of a company to implement this.

42. We don’t need more paperwork.

43. What is the return on investment?

44. We’ll talk to patients but we can’t pay them.

45. We are too big of a company, with locations all over the world. How could we coordinate this?

46. We are so overwhelmed, we can’t take on another initiative.

47. Is there a standard operating procedure for implementing this?

48. What happens if they all start talking about the adverse events of their treatments?

49. How can we trust patients?

50. Our investors don’t care about patient-centered practices and co-design. They want drugs going to market.

Pharma’s 50 shades of gray does not run industry wide. There are pioneers who are committed to changing the status quo, actively working with patients and including them on many fronts. It is evident that these trailblazers are excited by their partnerships with patients. They speak loudly and proudly about their patient-centered initiatives, with an enthusiasm that is invigorating and resounding. They acknowledge that this isn’t a just a nice gesture or outreach program. Partnering with patients is solid business sense.  Collaborating with patients bridges silos, brings meaning to daily work, and creates unique opportunities for experiential learning.

It is important to note that those within pharma who collaborate with patients are more open to leveraging technology and machine learning, discussing mobile health, digital platforms, and telehealth, exploring benefits of utilizing blockchain, as well as recognizing the importance of patient-reported outcomes. Coincidental? Absolutely not.  There is unprecedented value and power in including patients in optimizing the drug lifecycle. Augmenting trials to patients’ values, preferences, and needs is a solid win on all fronts. Do not mistake this as another passing trend!

Is your company somewhere in the 50 shades of gray? What is holding you back? Is your company a pioneer in being authentically patients first and collaborating with patients? How can early adopters share best practices to eliminate every single one of these 50 gray areas so as to collectively move the industry forward to being truly patients first?

The Need for Healthcare Experience Literacy

As an advocate and carepartner for over 20 years, I have seen things I can not unsee. I have experienced things I can not forget. I have heard things I can not unhear. I have come to understand all of my experiential learnings as reflection of a single, major omission in US healthcare. We don't teach anyone how to be a proactive member of the US healthcare system. I'm not just talking about patients or their carepartners. What about healthcare policy decision makers? How about those within pharma designing new medications? What about innovators creating new solutions to advance healthcare?  Shouldn't we all have the same foundation of knowledge to be members of our healthcare system? How are we preparing the next generation for healthcare?

Our pre-K through grade 12 public education is lacking severely in healthcare experience literacy. Literacy alone is not enough. Health literacy not enough. This is a call-to-action for healthcare experience literacy. Imagine the possibilities of ingraining the essentials of the healthcare system incrementally from early childhood through young adulthood! See my latest publication for more details:



Book Review: In Shock by Rana Awdish, MD

This May at the Cleveland Clinic Patient Experience Summit , I had the opportunity to hear a mind-blowing talk by a physician named Dr Rana Awdish. Her story was a personal account of how she literally died at her own hospital, losing her entire blood volume into her abdomen due to a ruptured liver tumor. Pregnant at the time, she lost the baby. She continued with her journey of pain, suffering, recovery, and healing while the audience sat pin drop silent, tears and sobbing audible. Her experiences as a patient transformed her understanding of medicine and how it should in actuality be practiced; with compassion, with empathy, and through making space for suffering and vulnerability. Needless to say, I couldn't wait to dive in to the pages of her book. Here's my review. 

Dr. Awdish tears down the walls housing her personal experiences as a doctor turned patient. She masterfully guides the reader through multiple vantage points: as a doctor expecting a child, to the loss of a child and her own “death”, to miraculous survival, painful determined recovery, multiple set backs, surgeries, and medical emergencies, with victories and profound revelations throughout.  You will need to put the book down to dry the tears that fall out of pure sympathy. The reader will experience complete disbelief that a single person could possibly endure such devastation, pain, and grief.  The story captivates with a raw authenticity, transporting the reader through a broad spectrum of emotions the reader couldn’t possibly be prepared to experience: disbelief, grief, devastation, sadness, victory, joy, and true hope.  Dr. Awdish’s deep inner reflections are juxtaposed with her seemingly endless battle for life, providing a thought-provoking framework for redefining the terms patient experience, patient engagement, doctor satisfaction, and the meaning of true healthcare. There is no doubt that medical education must be refreshed after experiencing this harrowing account.

Readers will undoubtedly leave this book permanently changed and rocked to the core. In Shock professes a convincing perspective on the need for compassion and human connection in medicine.  Dr. Awdish makes a clear case for the need for more empathy for doctors, patients, and their carepartners. She is a visionary enlightened by her profound experiences as a patient. This should be required reading by every medical and nursing student, every hospital administrator, technician, and staff member. There isn’t a single person who wouldn’t benefit from reading In Shock and experiencing the consequent opening of the soul first-hand. 


Pausing to reflect can be a powerful, grounding moment. I’m grateful for all that I am blessed with. A loving, supportive family. Happy, healthy children. A comfortable home. More than enough food to eat. A circle of incredible friends. A career path that is challenging and rewarding. Health and a mind filled with burning curiosity.

If I had to narrow my focus and more clearly define what I’m most grateful for, it would be the people in my life. They are priceless. My children, my husband, my family and friends. Additionally, there are the people I’ve met through my advocacy work. The patients. The carepartners. The advocates. The physicians. The nurses.  The students. The academics. The innovators. The disruptors. The challengers of the status quo.  The endless numbers of people who inspire me and leave me speechless with their works. For the people who disagree with me and challenge me to continuously consider other points-of-view.  For the many who continue to push and motivate me, and show me there is good happening in the world.

On this Thanksgiving, I’m eternally grateful for all of the people in my life.  For the people who make time to be a part of my life. For the people who continue to welcome me into theirs.

Wishing all of you and yours a very Happy, Happy Thanksgiving!


Photo by Pro Church Media on Unsplash

My (REJECTED) Letter to the Editor

          As a researcher, I can fully appreciate the review process and recognize that there is simply only so much space allotted in any given journal. My recent submission was a Letter to the Editor of the New England Journal of Medicine (NEJM) regarding a perspective “Saying Goodbye to Lectures in Medical School- Paradigm Shift or Passing Fad?” by Schwartzstein et al, on alternatives to traditional teaching formats in medical school.  Given the elite status of the NEJM, I wasn’t entirely surprised to receive a rejection. Perhaps my simple little opinion wasn’t written in cream-of-the-crop style. The more concerning alternative is that the submission was rejected because it was not representative of the masses of submissions received or the popular vote. Perhaps no one else feels strongly about incorporating patients and care partners in the design and delivery of medical education. I find this gravely alarming.

            Revising the manner in which knowledge is delivered, i.e., virtually, in Q&A sessions, flipped classrooms, augmented reality, etc., addresses only part of the issue of sustained learning in medical trainees. It is important to incorporate the power and influence of storytelling to enhance the medical education experience. It is important for curated curricula to foster life-long learning not only in students, but also in the medical experts responsible for shaping young minds.  Current medical curricula offer learning as a 1 way street with information being disseminated from professors to students. Medical education is missing patient and care partner stories and experiences. More on that here:

            Here’s my formal rejection from NEJM in response to my submission below. Does anyone else believe in the power of incorporating patient and care partner stories to enhance medical education?

Dear Dr. Cordovano,

I am sorry that we will not be able to publish your recent letter to the editor regarding the Schwartzstein article of 17-Aug-2017.  The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received.  Many worthwhile communications must be declined for lack of space.

Thank you for your interest in the Journal.




(Original Submission) To the Editor,

It was disappointing Schwartzstein et al. (Aug 17 issue)1 did not include patients and care partners in the design, development, and delivery of medical education. Students are only learning part of the story from cadavers and medical experts at respective institutions. We must foster the creation of curricula that are not only engaging, thought provoking, and evidence-based, but also unite patients and physicians, promote shared-decision making2, and delivery of compassionate care. Patients and care partners bring an authentic breathe of experience and perspective3 that textbooks and medical experts cannot impart or convey. It’s time to invest in participatory medicine and welcome patients and care partners to share their experiences living with disease significantly earlier into the careers of medical trainees. This model offers a unique opportunity to foster interactive, collaborative learning for all involved: medical trainees, seasoned medical experts, and patients and care partners. A change in the culture of medical education is more profound than revising curricula alone.


1.     Schwartzstein R, Roberts D. Saying Goodbye to Lectures in Medical School- Paradigm Shift or Passing Fad? N Engl J Med 2017; 377: 605-607

2.     Barry M, Edgman-Levitan S. Shared Decision Making- The Pinnacle of Patient-Centered Care. N Engl J Med 2012; 366: 780-781

3.     Awdish R. A View from the Edge. N Eng J Med 2017; 376: 7-9

The Glaring Omission in Kymriah Drug Approval Press Releases

Novartis received F.D.A. approval for Kymriah (tisagenlecleucel), as the first CAR-T gene therapy approved in the US for pediatric and young adult patients with relapsed B-cell acute lymphoblastic leukemia (ALL).  Kymriah is being hailed as a paradigm and life changing therapy. Clinical studies have shown that within 3 months of treatment, patients achieved overall remission rates of 83%, survival of at least six months by 89%, with a 79% chance of survival of at least a year. These are tremendous clinical feats for patients with limited to no treatment options. The price for the single treatment therapy is $475,000. Novartis is working with the Centers for Medicaid and Medicare Services where patients will only be responsible for payment if they respond after 1 month of treatment. The company has also reported it would provide assistance to those without insurance and the underinsured.

The CEO of Novartis Oncology, Bruno Strigini, said, “We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program(1). The majority of press releases (2-14) reporting the approval all had one glaring omission. Not a single press release formally recognized the importance of the patients that volunteered to participate in the trials. Not a single one expressed gratitude for the dedication of the care partners that committed their time to the success of these trials. Many trials fail to recruit and retain enough patients (15), leading to early termination, delays, or inadequate data for statistical reporting. Considering Kymriah is a treatment geared to a very specific subset population of ALL, it is incredible that these trials were able to accrue and retain the necessary numbers of patients to generate statistically significant findings.  Clinical trial participation requires dedication, sacrifice, and an uncanny belief in the unknown.  Imagine the degree of mental, physical, emotional, and spiritual duress a parent or guardian experiences in deciding whether their child, who is in the throes of a terminal cancer diagnosis, should participate in a clinical trial.  In the cases of pediatric and young adults patients, one parent, if not both, often need to significantly decrease the number of hours they may work, take an unpaid leave of absence, or leave their job permanently to assume the role of care partner for the patient so as to follow trial protocol. One can only imagine the impact on a single parent household. While there were clearly never seen before successes, with many precious lives saved, it wasn’t a miraculous ending for ever patient that was treated.  There are also life-threatening sides that come with treatment. Even the success stories may have had many dark moments along the way.

At a time when the healthcare industry is exploring and investing in initiatives to promote patient-centricity, it is important to acknowledge all stakeholders involved in successes such as these.  While Kymriah is undoubtedly a groundbreaking approval representative of the epitome of exceptional science, dedication, and innovation, let’s not forget to credit the patients and care partners who made this innovation and approval a reality as well. While researchers may have dedicated years of their careers developing the basic science and pharma may have invested close to a billion dollars to bring this living drug to market, the most invaluable part of Kymriah’s product lifecycle was patients’ volunteering their lives to the development of what’s being hailed as historic breakthrough science.


1.     Novartis. (2017, Aug 30). Novartis received first ever FDA approval for a CAR-T cell therapy, Kymriah (tisagenlecleucel, CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice [Press Release]. Retrieved from

2.     Berkrot, B. (2017, Aug 30). Novartis gene therapy approval signals new cancer treatment era [Press Release]. Retrieved from

3.     Cortez, M., Edney, A., &Paton, J. (2017, Aug 30). Breakthrough cancer therapy for dire cases gets FDA approval [Press Release]. Retrieved from

4.     The Food and Drug Administration. (2017, Aug 30). FDA approval brings first gene therapy to the United States [Press Release]. Retrieved from

5.     Garde, D. (2017, Aug 30). Pioneering cancer drug, just approved, to cost $475,000- and analysts say it’s a bargain. [Press Release]. Retrieved from

6.     Glenza, J. (2017, Aug 30). US approves first cancer drug to use patient’s own cells- with a $475,000 price tag [Press Release]. Retrieved from

7.     Grady, D. (2017, Aug 30). FDA approves first gene-altering leukemia treatment, costing $475,000 [Press Release]. Retrieved from

8.     Herper, M. (2017, Aug 30). Novartis CEO’s dilemma: Is $475,000 too much for a leukemia breakthrough? Or is it not enough? [Press Release]. Retrieved from

9.     Nedleman, M. (2017, Aug 30). FDA announces first US gene therapy approval for cancer treatment [Press Release]. Retrieved from

10. NPR. (2017, Aug 30). FDA approves first gene therapy for leukemia [Press Release]. Retrieved from

11. Ramsey, L. (2017, Aug 30). A medical breakthrough that hacks genes to fight cancer just got approved, and it’s the beginning ‘of a big new field of medicine’ [Press Release]. Retrieved from

12. Scotti, A. (2017, Aug 31). New cancer drug’s ‘astronomical price’ only affordable for the 1% [Press Release]. Retrieved from

13. Smith, M., Goodman, B. (2017, Aug 30). FDA approves first-of-its kind cancer treatment [Press Release]. Retrieved from

14. Univeristy of Pennsylvania. (2017, Aug 30). FDA approves personalized cellular therapy for advanced leukemia developed by University of Pennsylvania and Children’s Hospital of Philadelphia Retrieved from

15. Kolata, G. (2017, Aug 30).  A cancer conundrum: Too many drug trials, too few patients [Press Release]. Retrieved from


Robotics, Technology, and the Patient’s Clipboard

As a little girl, The Jetsons used to be one of my favorite shows to watch. An animated sitcom produced by Hanna-Barbera, The Jetsons featured a quaint family of 4 living in a space-age, futuristic era where daily life was rendered simpler by the glories of robotics, whimsical advancements, and high-tech innovations. I can still close my eyes and picture myself as a 6 year old, daydreaming about what the future would be like. 

Fast forward to August 2017. I’m watching a client struggle to wrestle their insurance card out of their wallet while juggling a clipboard with patient intake papers, her phone, and a water bottle.  Peripheral neuropathy stemming from many cancer treatments has made grasping things difficult and excruciatingly painful.  “But nothing has changed since last week, do you still need another copy of my insurance card?” asks the exasperated patient, still trying to free the pesky card from the tiny pocket in her wallet. “Office policy”, replies the receptionist curtly without looking up, “And fill out the forms because we are updating the records in our system”. There are 3 pages of forms. The patient has been coming here for over 2 years. All of the information is EXACTLY the same. She slowly fills out everything as diligently and neatly as she can, refusing my offer to help do it for her.

As a private patient advocate, I often accompany patients and their care partners to a broad spectrum of appointments, spanning follow-ups with their primary care physicians to specialists such as oncologists, cardiologists, or rheumatologists, to imaging centers for MRI’s, CAT scans, PET scans, and mammograms, to hospitals for pre-admission testing, surgical consultations, or procedures, or to phlebotomy labs for routine blood draws. I’ve observed hundreds, if not thousands, of patient encounters with front desk receptionists. No matter what the setting, there’s a common denominator routine that unites most of these experiences:

(front desk receptionist):  “Please fill out this paperwork (handing a clipboard to the patient) and I’ll need a copy of your insurance card.”

The moments that follow can be filed under “Complete Waste of Time”.

  • Patients can’t get their insurance card(s) out of their wallet.
  • Patients can’t find their insurance card in their wallet because the last time they were asked for it they were so flustered juggling the clipboard they shoved in a random spot.
  • Patients begin filling out the intake forms they’ve filled out many times before.
  • Patients realize they didn’t bring their glasses so they can’t actually read the form that’s also  often poorly photocopied.
  • The pen starts running out of ink a third of the way through.
  • Patients start looking for a new pen.
  • Some patients continue writing, pressing harder on the paper in hopes of reactivating the pen. Many curse, press harder, and rip the form.
  • Patients wait for the receptionist to return their insurance card so they may proceed to fill out the insurance information on the intake form.
  • Patients try to write their insurance information (ID number, group number, address, member phone number, etc.) on the miniscule lines on the form.
  • Patients can’t find the group number on the insurance card. (Insurance companies, take note!)

We are in a fascinating era of robotics, artificial intelligence, virtual/augmented reality, and digital technologies that fulfill people’s wildest imaginations.  The cancer surgical landscape is being transformed by advancements such as the da Vinci System (Intuitive Surgical), a robotically assisted surgical device bringing surgeons enhanced precision, dimension, and control while extending the possibility of minimally invasive surgery to patients  Robear (Riken), a bear-like nursing robot, can perform care-giving tasks such as lifting patients from their bed, transferring them to a wheelchair, and helping patients stand from a sitting position  Hospital acquired infections may have met their match with Xenex, the germ-zapping robot, which uses high intensity pulsed ultraviolet light from xenon lamps to significantly decrease microbial loads in hospital patient rooms  And who can resist the cuteness of the PARO seal (AIST), a therapeutic robot that fulfills unmet needs within the animal-assisted therapeutic space  This is just a sampling of the wonders out there. There are even wide spread reports anticipating a robotic takeover and fears of automation replacing humans in a variety of sectors. With all of this pure genious rocket science and technology, can someone please explain to me how the hell patients are dealing with clipboards, insurance cards, fax machines, and paper chart folders with 3-hole punched paper records? Dear technology, you’ve missed the mark. You need to go back to the basics and fill in the (MAJOR) gaps before aspiring to have robots take over the world.

Many aspects of healthcare are not the futuristic Jetsons-like encounter I daydreamed of as a little girl. Dear Apple, for the love of all that is holy, please tell me there is an solution in the making that will allow patients to wave their phone Apple Pay-style to confirm basic demographic patient and insurance information so we can simplify the patient in-take process at every healthcare facility touch point. And while you are at it, lets have the capability to pay any co-pays with a second wave of the phone.  I mean enough with this cash, checks, or digging for a credit card nonsense.

Alternatively, at this juncture, it may be easier to perhaps bring in Pepper (SoftBank Robotics), the humanoid robot, into waiting rooms across the nation as an acting patient assistant to fill out the damn paperwork and get the insurance cards out for patients I’ll bet you a dollar it may easier than solving the current shortcomings and interoperability issues surrounding electronic health records (EHR) and patient portals.  It may also be more pleasant of an experience than many of the interactions I’ve witnessed with some front desk receptionists. Dear tech companies, looking forward to what you come up with. In the meantime, excuse me while I go find a pen that works for my client.

The Fix for Healthcare: A Tsunami

Dearest Medical Schools,

            Recently, at the 8th Annual Patient Experience Summit, Adrienne Boissy, MD, MA, Chief Experience Officer at Cleveland Clinic Health System, encouraged conference attendees to “dream bigger”.  Since then, I’ve been plagued with many sleepless nights and perhaps what many will consider borderline insanity.  I assure you that what I’m going to ask of you today is truly my version of dreaming bigger.  So here goes.  It’s time for you to invite patients to speak to promising young doctors during their time at your respective schools.  Not just for a volunteer opportunity.  Not just for a Patients’ Day event.  Not just for a photo-op for your quarterly donors newsletter.  You need to invite patients for regularly scheduled story sharing.  Don’t roll your eyes at me just yet.  It’s time to invest in patients and their stories to enrich your curated curriculums.  To clarify, by invest I mean not only to welcome patients to your exceptional facilities but to compensate them for their time as well.  Please don’t stop reading just yet.

            Your students are only learning half of the story from the cadavers and medical experts at your prestigious facilities.  For medical students to truly learn and understand the other half of the story, you will need to depart from the way things have always been done and revamp the medical school experience.  My dearest medical schools, you need to change the lens your students are looking through to learn. They need to understand the human repercussions of the diseases they so astutely diagnose.  They need to share and revel in the joys and tribulations of a parent whose child was miraculously saved.  Your young doctors need to experience the recollections of a spouse who tragically lost their loved one to a difficult battle with cancer.  Your knowledge hungry students need to hear first-hand the accounts of those living with painful, chronic diseases. Your students need to see the effects of avoiding difficult end-of-life conversations and the unnecessarily prolonged deaths adult children see their aging parents endure.  Students need to hear about successes of truly delivering consistent, quality care and the difference simple eye contact and active listening to a patient truly makes.  Young doctors-to-be need to hear first hand about near death or true back-from-the-dead experiences. It’s one thing to learn about death from a textbook or to see a patient code in the hospital. It’s another thing to be in a pin-drop silent room and hear the riveting account of those who have experienced their own death and have shockingly fought all odds to come back to tell their story.  These young, curious, motivated minds need to hear the accounts of everyday patients and the challenges they routinely face.

            There are two sides to every story.  Your students need to hear from those “non-compliant” patients that show poor medication adherence to understand their financial struggles, their difficulties getting to appointments and to the pharmacy, their challenges with suffering from debilitating side effects.  We can’t continue to ignore the impact of social determinants of health on patients.  Your young doctors also need to hear stories about wonderful care that’s being delivered across the nation, care that nurtures, supports, and empowers patients because there are incredible things happening everyday.  We need to inspire them because not all is lost and forsaken.  Your students also need to hear about terrible, undermining, exploitive care.  Care that left patients hurting, feeling lost, abandoned, taken advantage of, and hopeless.  Poor care and communication that brought patients back to the ER or ended up in medical errors and death.  Don’t forget about including doctors and nurses who have reversed roles and become patients themselves.  Their experiences will be uniquely different yet completely eye-opening.  Their takeaways will be pertinent.  I can assure you, the gut-wrenching emotional roller coaster that comes with the accounts of patients, such as Dr. Rana Awdish, Director of the Pulmonary Hypertension Program at Henry Ford Hospital and author of “In Shock”, Mary Elizabeth Williams, author of “A Series of Catastrophes & Miracles”, or of Dr. Lucy Kalanithi, widow and caregiver of Dr. Paul Kalanithi, “When Breath Becomes Air”, are priceless.  But these accounts only scratch the surface.  We shouldn’t only focus on well-published stories.  We need to seek the activated patients in our local communities, amplify their voices, and listen.   Really listen.  It’s in their messages that we will find solutions to heal our broken healthcare system.  Dearest medical schools, I ask you to be the early adopters our healthcare system is crying out for so desperately.  Give your students a medically cutting-edge education that is bathed in the human experience.  We need to dispel the myth that there simply isn’t time for such initiatives.  Time is always there.  It’s priorities that need to be adjusted. Be the disrupters in healthcare that reintroduce empathy into the sanctity of the doctor-patient relationship at it’s earliest kindling.

            Let’s not forget to include patient caregivers as they are the boots-on-the-ground at home when there isn’t a doctor or nurse in sight. (Don’t roll your eyes at me again.)  They dedicate more time to the patient than any individual doctor or nurse ever will.  Caregivers know the patient better than any doctor or nurse, and sometimes, even better than the patient themselves.  Invite them to share their stories, their trials, their heartaches, their happiness, and their grief.  I assure you the results will be lasting and profound.  If you still need convincing, you need to listen to Regina Holliday, founder of the Walking Gallery, speak.  Regina’s passion is fueled from her experiences advocating and caring for her husband, Fredrick Allen Holliday II, who died at 39 years of age from kidney cancer.  Together they faced endless complications stemming from poor care coordination, medical errors, lack of transparency, and poor access to his medical records.  Regina’s words will reverberate through your soul.  Again, there is a sea of caregivers waiting to share their stories.  I urge you, don’t wait a second longer to start reaching out to them.

            We need to start a movement, incorporating patients’ and caregivers’ stories and experiences into medical education and healthcare design. It’s a blatantly missing piece.  As you can see, without it healthcare is falling apart at the seams.   This can’t start and stop at medical schools.  We need to extend this to nursing students and medical technicians.  Anyone that plans on working in healthcare, from the chief of the department to the nurses, to the phlebotomy technician, to the custodial or food and beverage staff, every individual needs to hear patient and caregiver stories. Dearest medical schools, I’m asking you to be the drop of water that disrupts the surface of healthcare, the ripple of which will reach far and wide, outside of medical and nursing schools, outside of hospitals. If many medical schools participate, that ripple can become a tsunami. As far as I know, tsunamis are unstoppable.

            Empathic design and patient-centered care are buzzwords of all the rage. Empathic design isn’t about the soothing shade of white paint selected for a new hospital building.  It isn’t about incorporation of more natural light and miniature indoor gardens into hospital foyers. Patient-centered care isn’t just about improving Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. Dearest medical schools, do you want an innovative, esteemed educational program that truly embraces empathic design and patient-centered care?  Invest in patients and their caregivers and let me know how it goes.  I bet you a dollar it’s going to be simply earth shattering and amazing.  Looking forward to witnessing the tsunami.

Best wishes,

Grace Cordovano, PhD

Aid-In-Dying: A Declaration of Independence from Terminal Cancer

          In February 2017, in the case of Arthur v. Dunn, the Supreme Court rejected the appeal of death row inmate, Thomas D. Arthur, to be executed by a firing squad, which offered a potentially less painful, faster death in comparison to lethal injection. In a dissent to the Supreme Court’s decision, Justice Sonia Sotomayer wrote, “In addition to being near instant, death by shooting may also be comparatively painless. Justice Sotomayer also stated, “Condemned prisoners, like Arthur, might find more dignity in an instantaneous death rather than prolonged torture on a medical gurney.”

         After reading the quoted statements, I was mentally consumed by the juxtaposition of the concept of dying with dignity in death row inmates vs. patients with terminal cancer. Lethal injection has been criticized as inhumane due to shortcomings in executions where inmates have experienced pain and suffering on the approximate scale of an hour or two from the time of initial drug administration.  Many terminally ill cancer patients suffer difficult, painful deaths for significantly longer than the “prolonged torture on a medical gurney” death row inmates have experienced as stated by Justice Sotomayer.

         Medical aid in dying (MAID) is the prescription of a lethal dose of medication by a physician to be taken voluntarily by a mentally competent, terminally ill patient. Oregon, Washington, Vermont, California, Colorado, and Washington D.C. have Death with Dignity statutes. Montana has the end-of-life option via Supreme Court ruling.  Safeguards require patients to be terminally ill adults who reside in of one of the participating states. Patients must be mentally competent, not depressed, capable of making medical decisions for themselves, and determined to be acting voluntarily. Patients must make 2 oral requests, 15 days apart followed by a written request.  Patients must ingest the medication themselves. Even if a patient is approved for a MAID prescription, they are under no obligation to ever use it. MAID is not euthanasia, which is illegal throughout the entire United States, as physicians do not directly administer the medication to patients. MAID is not assisted suicide. These patients are not suicidal and must be medically cleared of any mental health illness or potential depression as part of the vetting process.

         Terminally ill cancer patients are a unique subset of patients with distinctive unmet needs. Chemotherapy, radiation, immunotherapy, and surgery are associated with a broad spectrum of side effects, some which are permanently debilitating. The collateral damage ensued by these treatments are often silently accepted to be the price to pay for choosing to fight cancer in hopes of preserving life. Unfortunately, some cancers continue to ravage on in utter defiance of every gold-standard treatment and medical strategy that is employed. When all options have been exhausted, patients are referred to hospice for comfort care. Hospice provides significant benefits to both the patient and their loved ones. But what happens when hospice fails to bring comfort, pain relief, and peace to terminally ill cancer patients?

          Opponents of MAID state the practice is unnecessary as hospice can manage all pain associated with end-of-life. Unfortunately, it is well known that many terminal cancer patients die after prolonged suffering in pain while in the care of hospice. Cancer pain management is complex, comprised of a collection of cancer pain syndromes that may require multidisciplinary expertise for management. Hospice staff may not be adequately trained to manage multifaceted situations presented by terminally ill cancer patients. Hospice also has limitations that impact their level and quality of care. Medicare may not cover services and medications that are most needed in terminally ill cancer patients. Restrictive enrollment policies prevent enrollment of patients utilizing palliative chemotherapy or radiation.  It’s interesting to note that in a society that values life, terminally ill patients are required to forego all curative therapies in order to qualify for hospice. Many facilities are understaffed, with many reports of lack of continuous support by hospice during times of patient crisis. Distressed cancer patients receiving hospice care at home are often transported to the emergency room and admitted. There they are subjected to needles and IV’s, often over-treated and over-medicated. Doctors may resuscitate, crack ribs, intubate, perhaps do an emergency surgery or procedure, or place the person on a ventilator. Hospitalized for their remaining days or weeks, patients develop bedsores, pneumonia, delirium, and increased risks for falls. They are heavily medicated and hooked up to more monitors and machines than they ever could have imagined.

          Physicians who are opponents of MAID state the practice violates the doctor-patient relationship and their Hippocratic vow to do no harm.  Perhaps in subsets of cancer patients with terminal disease, the harm has already been done. These are patients who have followed the recommendations of evidence-based medicine, often having endured multiple rounds of chemotherapy and are now consequently plagued by side effects such as crippling bone and joint pain or excruciating peripheral neuropathy. These are patients who may have endured multiple rounds of radiation and consequently may have permanent, unbearable damage to the esophagus, brain, or heart. These terminally ill cancer patients may have endured numerous surgeries and resections of their tumors, often sacrificing healthy organs and tissue in pursuit of life. On top of mounting chronic treatment side effects and uncontrolled disease, perhaps they have lost control of their bowels or have a colostomy bag. Some patients experience severe nausea and vomiting requiring a percutaneous endoscopic gastronomy (PEG) tube for relief. A previous client of mine with terminal cancer referred to himself as a medically altered, part artificially functioning version of his pre-cancer self, forced to endure prolonged and unnatural suffering.        

            Most patients seeking MAID are not primarily looking for relief of physical pain and suffering. At the time they request MAID, they greatly value their lives and quality of life and are seeking to preserve the authenticity of their life. Many seek preservation of autonomy, dignity, and compassion, virtues that elude the tangible framework of medical treatment and care. Many fear the loss of control and medical manipulation described above. In the cases when medicine cannot cure a cancer, where palliative care is not enough to manage treatment side effects, where hospice cannot provide solace and support, and hospitals continue to admit and readmit, prolonging death unnaturally in the last days and weeks of a cancer patient’s life, what choices do terminal cancer patients truly have at the end of their life?

          Not all terminally ill cancer patients will seek or need MAID.  MAID should not be viewed as the primary resource for end-of-life care, but rather another choice in the delicate decision process. For many terminally ill cancer patients, MAID will never be a consideration due to personal, cultural, or religious beliefs. For those with access, palliative care may be enough to manage cancer patients’ treatment side effects while they are undergoing cancer treatment. For most patients, hospice will be a beautiful experience and should lead to a supported, peaceful death. We cannot, however, continue to turn a blind eye to the populations of terminally ill cancer patients that wish for another choice. Terminally ill cancer patients should have a right to be given the choice to request MAID within the proper safeguards. And even if they are granted the choice, not all will exercise that right.  But having the choice and option may make all the difference. Doctors should not be forced to participate in writing lethal prescriptions and in the same respect, doctors who do should not be ostracized by the medical community, accused of homicide, or slandered by the media. Legal, medical, and religious organizations all have a responsibility to contribute and continue to improve end-of-life care. But let’s empower the actual terminal cancer patient with a choice FIRST.