Stepping Stones

I vividly remember walking into my grad school mentor's office, sitting down at the table and chairs, and fretting, "Dr. Schramm, I'm so torn about what to do: do I pursue the post-doc or do I take the position at this start-up in the city?”

I absolutely loved bench research, adored biochemistry, and hated cancer. My thesis research entailed characterizing the mechanism of action of a transition state analog inhibitor as a potential chemopreventive agent in various cancer models.

There was nothing like watching cancer cells die in culture or mouse models. It was intoxicating. Generating data that could be replicated and was statistically significant was the most incredible high. I would have worked 24 hours a day running experiments if some version of sleep wasn’t required daily.

But there was a tangible void. Research left me wanting for so much more. I philosophically struggled with mainly concentrating on one aspect of a metabolic mechanism out of potentially thousands and thousands of others out there. This narrow focus left me hungry for intersectionality and cross-functionality, which my work didn't provide.

As a kid, I faithfully watched Nickelodeon’s Mr. Wizard’s World. I tried replicating a bread mold experiment when I was about 5. It was a huge success (until my mother found the moldy mess under her bed where I had chosen to incubate it.)  

As a teenager, I helped too many loved one’s navigate their cancer diagnosis and witnessed immense suffering. I grew up down the road from Hoffman La Roche US headquarters, and every time I drove by there, I remember peering through the back seat window of my mom’s car dreaming about going to go into pharmaceutical research in hopes of developing new drugs for cancer.

Bench research seemed like the way to go until I came across an opportunity while randomly searching Monster.com for positions with a Ph.D.  

The words “Medical Strategist” glared at me from the screen. I remember clicking on the opportunity to read the job description. There was no turning back from that job description.

The medical strategy opportunity was a start-up in the heart of Manhattan at a data analytics company building competitive intelligence platforms for Pharma and Biotech. 

There were many technical aspects to the work, including query development and natural language processing. I remember thinking at the time, what the heck was natural language processing?! I submitted my resume and cover letter.

I started polling my colleagues, mentors, as well as professors in the coming days on their perspectives: do I leave the ivory towers and pursue an opportunity with a start-up? One of my closest mentors, Dr. John Blanchard, looked at me when I asked for his opinion and laughed out loud as he took a drag of his cigarette. "A start-up? Why the *uck would you go for a start-up?!".

The responses included:

·      That's a waste of a Ph.D.

·      Scoffing, eye-rolling, looks of disgust.

·      It's OK if you can't handle post-doc and need a way out (ouch).

·      I guess if you want to have a family, a start-up is a safer choice (double ouch).

·      That's career suicide (good grief).

·      You'll never get to the National Academy of Sciences.

That last one stung. I had a deep admiration for my boss, Dr. Vern Schramm, who was just elected to the National Academy of Sciences. It was a dream I aspired to one day myself.

In the meantime, I received an invitation for an interview and then an offer for the medical strategy position.

In one final conversation with my boss, I said, “I know nothing about natural language processing, query development, or business strategy.”

I'll never forget what he said, "Say yes to any opportunity that comes your way and figure it out later." 

I made my final decision. I traded my white lab coat and post-doc for a new pair of heels that walked me right to my office next to the Chrysler Building.  

My life has been a series of unconventional stepping stones to the unknown, where each stepping stone was an opportunity I welcomed with uncertainty accompanied by a determination to figure it out.

The stepping stones haven't been easy. Some stones were in the middle of a flash-flooded Colorado River.

A diagnosis of advanced lymphoma brought my world crashing down in 2008. Ironically the start-up I worked at was a few blocks from Sloan Kettering Cancer Center, where I went for my second opinion. I was able to manage a flurry of incessant doctor appointments, lab work, imaging, biopsies, and eventually video-assisted thoracic surgery (VATS), and recovery from surgery due to proximity and the immense support of my new boss and team.  

After four months of all types of care at Sloan, I was discharged post-op and cleared of a cancer diagnosis, now diagnosed with a fungal infection I had gotten on my honeymoon called histoplasmosis. I was stunned by the miraculous news but grappled with why it was me that was spared.

I met so many other patients while at Sloan. Why was I given a clean bill of health and not the mother in the waiting room with two young kids, the grandma trying to make it to her grandson's wedding, or the teenage soccer player in high school? I cried with guilt.

I remember feeling embarrassed when I walked the halls of my hospital floor while recovering from surgery when I ran into other patients walking in the halls, and they asked me what my cancer was. I held back tears and hung my head as I said, "It's not cancer; it's a fungal infection." Each patient genuinely congratulated me. I wished there was a way I could take their suffering away.

I slowly healed and eagerly returned to work, where I was quickly promoted to Director of Medical and Scientific Affairs. Turns out I had a natural knack for medical strategy and competitive intelligence. I became obsessed with data analytics, market landscapes, NLP, query development with the help of an amazing colleague who was a linguist, and helping companies best position their pipeline agents to go through trials and get to market.

One day, I randomly read an article in the New York Times about patient advocacy as a profession. I was intrigued. I had been a patient advocate since I was a kid. You could do this professionally?! I filed this away in my mind for another time. 

Fast forward a few months later, my daughter was born and was a colicky baby that had silent reflux, cried for 12+ hours a day, and did NOT sleep like a baby.  I quickly learned how little sleep a human body could (sort of) truly function on. An aspiration and scary 911 call ensured I’d never sleep again, constantly checking her breathing each night.

As maternity leave came to an end and the sleepless nights and crying persisted, I knew I couldn’t go back to commuting to the city and my long hours. I resigned from my position. The mix of postpartum blues and exhaustion made the resignation feel, indeed, like career suicide.

The next stepping stones presented themselves: working from home and diving into patient advocacy as a profession. My practice, Enlightening Results, was born. Patients started calling for help.

I've been presented with many stepping stones over my years in advocacy. I've had the privilege of working with countless patients and families over 20 years. I've had the opportunity to represent the patient voice in many collaborations with national organizations and federal agencies.

If I'm faced with a new opportunity, I cross-examine it with:

·      Will saying yes help improve the lives of patients?

·      Will it bring meaningful change?

I don't take walking out of Sloan Kettering cleared of my cancer diagnosis lightly and intend to use my time wisely and intentionally.

Most recently, I accepted the opportunity to serve on the National Academy of Medicine's Artificial Intelligence Code of Conduct steering committee.

 As I approached the front of the National Academy of Science’s building, I couldn't help but smirk as I was greeted by the ivory stairs. I may not have taken the post-doc much to the dismay of my mentors and colleagues, but ironically, I made it to the National Academy of Science through an unexpected series of stepping stones.

As I left what was an exceptional steering committee meeting filled with hours of thought-provoking and illuminating discussions on crystallizing a framework for the responsible use of AI in healthcare, my life came full circle as I crossed the front lawn of the National Academy of Sciences. There I was, face-to-face with a 12-foot statue of Albert Einstein.

 My life had come full circle. 

I completed my Master's and Ph.D. at Albert Einstein College of Medicine in the Bronx. When I graduated from Albert Einstein, I received an acrylic plaque that is still on my desk. It reads, "A life lived for others is a life worthwhile," a quote by Albert Einstein.

In that moment, as I stood looking at the statue of Albert, I reflected that I still don't know all the reasons why I'm here, but my work brings me joy, and I know I am right where I'm supposed to be.

I'm grateful for all the stepping stones that have led me here. I look forward to the stepping stones still yet to come.

The Silence is Deafening

In the last few days, I have reached out to 4 different clinical trial study information support lines and individual study sites for patients to potentially enroll.

Not one reply or call back.

No auto-response messages.

No chatbot.

Nothing.

For all the efforts and hype on the latest digital health innovations in patient clinical trial matching, expediting patient recruitment, increasing population diversity, as well as efforts towards decentralized trials, we repeatedly don't get the basics right.

Individuals searching for clinical trials, for themselves or for loved ones, are often desperately seeking options when a diagnosis, like cancer, has shattered a life.

Is it too much to ask to get a reply when someone reaches out about wishing to possibly enroll in a clinical trial?

Not only do we not do enough to proactively educate and introduce patients to the potential of clinical trials significantly earlier in treatment planning, we fail patients by not ensuring that the basics of customer support are functioning and on standby 24 hours a day.

Cancer doesn't have off-hours, holidays, or go OOTO. Most individuals are working or occupied with life’s obligations and commitments during “regular business hours”. Most individuals are likely searching for clinical trials during business off-hours, weekends, holidays, and their own personal time-off. How are we meeting these individuals where they are?

Imagine spending hours searching clinicaltrials.gov, narrowing down potential studies, having questions about eligibility, reaching out and NO ONE CALLS OR EMAILS YOU BACK.

Imagine not even getting a generic auto-response email acknowledging that your inquiry was received. What an unbelievably lonely, hopeless, and abandoned place this is!

For the record, this is not:

·      Patient-Centered

·      Patient-Focused

·      Patient First

·      Putting the Patient at the Center

but rather in strict contrast with what is typically touted at most pharma and biotech industry clinical trial focused conferences & company websites. 

We hear the grim statistics about how globally more than 80% of clinical trials fail to enroll,  resulting in study extensions, addition of new study sites, or complete termination.

We know how poor the lack of diversity is in enrollment and clinical trials in general. 

Explain to me how we repeatedly don't answer the door when patients come knocking? Stop saying patients are reluctant to participate. Please, please, open the door and pick up the phone when we call. Our life, our the life of our loved ones’, may depend on it.

Study sponsors, are you calling and contacting your information hotlines regularly to check on response times or to see if you even get a response? Do you have continuous coverage during off business hours and holidays?

Study coordinators, have you tried reaching out to see if you can get emails and calls back? Do you recognize that not everyone celebrates the same holidays or closes for end of year with OOTO messages? Life-altering, life-limiting diseases have no days off.

 Any patient inquiries should be triaged to a human being to directly follow-up as soon as the inquiry for possible enrollment hits. In our hyperconnected world, there is no excuse for not having real-time support 24 hours a day, 365 days a year.

You can't only market 24/7/365. For clinical trials to be successful, you have to be ready to connect and welcome in real-time. This is not a technology issue. It is a clear lack of priorities and not meeting people where they are.

Patients reaching out with interest in clinical trials is authentic patient engagement.

If I repeatedly run into this problem in my patient advocacy work as a seasoned professional, what hope does the average individual have in connecting to trials? As we look to 2022 for priorities and goals in the clinical trial arena, please make sure to make answering the knock on the door and picking up the phone when it’s ringing an essential fix.

 

 

What is a Carepartner?

The words we use matter. The word caregiver is often confusing for patients and their families, especially in the context of limited English proficiency and language barriers, as the word “caregiver” in health care is used interchangeably to refer to the doctor as well as to non-clinical individuals who are caring and supporting a patient.

Patients living with chronic illness, disability, rare disease,  life-altering, and life-limiting diagnoses often describe feeling a sense of a loss of autonomy and independence. They may feel guilt for needing the support of loved ones and not being able to fully care for one’s self or fulfill household obligations due to their health conditions. Many patients say they dislike needing a caregiver and despise the word. Needing a caregiver is a constant reminder of their illness and loss of dignity. The word “carepartner” is more positively received. A carepartner is a spouse, life partner, sibling, parent, family member, friend, or colleague who is there to support a person living with their diagnosis(es). A carepartner can be thought of as a team mate and support who is there, in sickness or in health; their actions defined by love and empathy, not sickness.

FDA Approves First COVID-19 Vaccine

More than 92 million individuals in the US have received the Pfizer/BioNTech COVID-19 Vaccine under emergency use authorization (EUA). The vaccine has repeatedly demonstrated to be safe and effective in reducing the risk of severe disease, hospitalization, and death.

After reviewing hundreds of thousands of pages of data, the FDA has officially granted the Pfizer/BioNTech vaccine full approval for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will now be formally referred to as Comirnaty.

Official FDA press release here: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

At this time, the vaccine will continue to be available under emergency use authorization (EUA) for individuals 12-15 years of age and for the administration of the third dose in certain immunocompromised individuals.

See all FDA details here: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

See all Frequently Asked Questions (FAQs) here: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/comirnaty-and-pfizer-biontech-covid-19-vaccine-frequently-asked-questions

Pfizer has said it expects to have vaccine trial data on children ages 5-11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.

Moderna submitted its data about a month later for formal FDA review so stay tuned.

Safe and effective vaccines are critical public health tools that we in the United States are very privileged to have access to. Vaccines backed by rigorous science have historically eliminated some of the world's most horrific diseases. Vaccination is critical for public health, individual health, protection of the most vulnerable, the immune-compromised, and those who can not get vaccinated yet such as children. Vaccination also prevents the development of future variants that may one day be completely vaccine resistant, a grave concern we hope to never see. Lastly, vaccination prevents the overwhelming strain on our nation's health systems, many of which are at capacity with COVID cases and can not care for regular emergencies and critical care such as accidents, heart attacks, strokes, cancer, surgeries, etc.

Please get vaccinated. #ThisIsOurShot

USCDI Task Force

Truly humbled and beyond thrilled to be invited to serve on the U.S. Core Data for Interoperability (USCDI) Task Force, a subgroup of the Health Information Technology Advisory Committee (HITAC). The USCDI is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.

The USCDI Task Force is currently charged with reviewing and making recommendations on the Draft USCDI Version 2 content and process. I am committed to ensuring that the patient and carepartner perspective and unmet needs are amplified throughout this rigorous and critical review process.

I look forward to listening, learning from, and collaborating with my esteemed colleagues on the Task Force who have been tirelessly leading the way to a world where health information flows seamlessly and actionably, to a place where data silos no longer exist.

https://www.healthit.gov/hitac/member/grace-cordovano

My First COVID19 Vaccine: What to Expect

My First COVID-19 Vaccine: What to Expect  

Last week I had the opportunity to do something surreal. I received my first dose of the COVID-19 vaccine. Here’s a step-by-step look at my experience and what to expect.

With my mask on, I walked through parking lot M of the Meadowlands Complex where there was a good number of cars. An officer from the National Guard greeted me at the gate (note: don’t forget to thank all the National Guards for their service!) at the entrance to the ramp leading to the Meadowlands Racing & Entertainment Complex which has been converted into the Bergen Country Vaccination Mega Site.  He directed me up the ramp and assured me that officers from the National Guard would be inside to help guide each step of the way.

I had a copy of my eligibility confirmation for tier 1A and my appointment confirmation ready in hand as I walked through the Vaccination Entrance door. Make sure to bring yours with you to make things go smoothly!

It was 12 pm. There was no line. (Amazing!)

Inside at the first counter, I was greeted by 3 officers, one of which verified my confirmation forms and asked to see my driver’s license. I was given a credit card-sized plastic white card with a QR square and told to stay to the left and walk down the length of the corridor marked “Registered”. There was another line for “Unregistered”. When I inquired for more information, I was told that this allowed people to register on-site if they did not do so already. In NJ, you can pre-register for the COVID19 vaccine here: https://covidvaccine.nj.gov/

I walked down the long corridor until I reached another National Guard officer who directed me to an area with about a dozen tables in 2 rows with Hackensack Meridian Health (HMH) representatives helping individuals.  I waited about a minute for the next available table and was asked by the associate for my confirmation forms, driver’s license, and insurance information. The associate was very friendly and offered a complementary HMH mask and hand sanitizer. (definitely grabbed a mask.)

I was given a small index-sized card,  COVID-19 Vaccination Record Card, to fill out my first and last name and date of birth. I was instructed to keep this card safe as it would be the records of my vaccinations and the vaccine details. (In 2021, it is very disappointing that I can’t have this easily digitally stored. This is not the vaccination site’s fault but a bigger problem in healthcare called lack of interoperability. Today is not the day for that conversation.)

Next, I was asked to fill out a form with COVID19 Vaccine Discussion Questions. As someone with a history of anaphylaxis that needed emergency treatment in the hospital, I marked “YES” for question 2 “Have you ever had an anaphylactic or severe reaction to any vaccine or injectable medication?”.

I was given handouts on:

1.     the Pfizer vaccine (which was the brand that this site was administering; the Moderna vaccine was not available here today.)

2.     post-vaccination facts, with details such as common symptoms to expect

3.     v-safe, the after vaccine health checker. This is an easy-to-use smartphone app that helps track vaccine safety.

 The representative scheduled my 2nd vaccination appointment and wrote it on the COVID-19 Vaccination Record Card and I was told to walk down to the next checkpoint.

Sure enough, a short walk later, another National Guard officer greeted me, scanned my QR card, and directed me to the next stop.

This took all of 5 minutes from the moment I walked through the front door.

At the next checkpoint, I could see the vaccination area and felt my stomach sink. As a well-documented vasovagal (AKA fainter), I prayed to all that was holy that I didn’t faint and then have an anaphylactic reaction.

When it was my turn, I was asked to sit at the next open seat at one of the tables. One of the volunteers reviewed my paperwork and we discussed my history of anaphylaxis and fainting. A nurse was called over, we discussed the protocol. She instructed me that the injection had to be administered while sitting as there were no beds to accommodate lying down (as is often the alternative when faced with a fainter…like me.) The nurse went to get an epi-pen. The nurse was wonderful and kept me in conversation and to focus on my breathing. I closed my eyes while I received the injection in my left upper arm (no, I don’t watch).

The woman administering the injection was fantastic. There wasn’t even a pinch. Completely painless. I was asked to sit for a few minutes to see how I was feeling. I felt fine.

 I received a sticker that said “I made COVID-19 History” with the time 12:25 pm.

My COVID-19 Vaccination Record Card was filled out with the lot number for my Pfizer vaccine, today’s date, and the name of the volunteer that administered my shot. I was reminded to not lose the card. I took a picture of it with my phone just in case.

The nurse walked me over to the next checkpoint for the observation area where she let the National Guard officer know that I needed to be monitored for 30 minutes due to my history of anaphylaxis. All others are monitored for 15 minutes. All the chairs were well spaced apart and there were only a handful of people there waiting. I was given a seat in the corner of the first row of the observation area where two National Guard officers were stationed. They checked in with me to ensure I was feeling ok every few minutes. There was also a volunteer that was walking around to briefly see how everyone was doing and feeling after their shot. He shared in conversation what his experience was with his first dose (which was very positive).

While I waited, I scanned the v-safe QR code and registered myself in about 2 minutes.

 There was no pain or discomfort at the injection site. The band-aid was the only indicator anything had taken place.

 After a half hour, I walked towards the exit checkpoint where I thanked the officer for their service and my plastic card was collected.

 There was a banner for a photo-op and you know how the saying goes, if you didn’t take a photo, did it even happen?

Immediately after the shot, I drove home minutes just in time to be only a few minutes late for my next Zoom meeting at 1:30 pm.

 The only immediate side effect to report was hunger because I missed lunch.

After about 6 hours after my vaccination and I had a tiny bit of soreness (scale of 1-10, the soreness was a 1.) The next day the soreness was more noticeable at about a pain of 4. But I still managed to go through my day with no restrictions. I reported my mild soreness and updates daily via the v-safe app and still do.

Next dose: Feb 9th.

 Thank you to everyone at Hackensack Meridian Health for a seamless COVID-19 vaccination experience. All of your hard work shone through.

 Thank you to the wonderful nurse, I believe Michelle, who carefully reviewed everything regarding my history of anaphylaxis and fainting, stayed with me through the injection and ensured I got over to the observation area without any issues.  

Thank you to all of the NJ National Guard officers who are working to ensure all goes smoothly and we move the needle on getting NJ to herd immunity as soon as possible. Thank you for your service!

#ThisIsOurShot #VaccinesWork #PatientAdvocacy

 

 

 

 

 

Navigating Medicare Open Enrollment

Open enrollment periods are often overwhelming for many patients, carepartners, and families. With the Medicare open enrollment deadline approaching on Dec 7th, below is an excellent guide from the Patient Advocate Foundation on navigating original Medicare and Medicare Advantage.

Looking for more personalized advice & an actual person to speak to? Check the open enrollment letter from your local hospital where you may receive your care. Near the bottom of the letter, there may be a number that will connect you with an expert insurance agent that can address any specific questions you may have.

Do you have other tips? Share them below!

https://www.npaf.org/wp-content/uploads/2020/11/Medicare-Guide.pdf?sourceid=1065075&emci=d2bd429b-b825-eb11-9fb4-00155d03affc&emdi=4199801e-c329-eb11-9fb4-00155d03affc&ceid=751853



Over My Dead Body

If you died today, who would you want to have access, or not, to your medical records? The Health Insurance Portability and Accountability Act (HIPAA) ensures that personal health information (PHI) is not wrongfully used, improperly accessed, or shared. Did you know that HIPAA also protects an individual’s right to privacy for up to 50 years after their death?

Read on to learn about:
👉why your loved ones may need access to your medical records after your death. (**THIS IS A MUST READ LIFE-HACK**)
👉what guardrails are in place guiding access to a deceased individual's medical records.
👉challenges and information blocking routinely encountered by families.
👉how to prevent access being denied when it's needed the most.

https://www.unblock.health/blog/over-my-dead-body/

SalivaDirect: Spitting Is Now Encouraged

SalivaDirect received emergency use authorization (EUA) FDA approval today.

What's the big deal about SalivaDirect:


👉uses saliva that can be collected in any sterile container; no more long, uncomfortable swabs. (PS- there are reported shortages of the preferred thinner swabs, which means larger, thicker swabs are being used. Not fun.)

👉it's an approved protocol, not a kit. Any approved lab will be able to run these tests with materials they already have. A huge positive considering all the challenges we face with supply chain shortages.

👉costs a few dollars to run, not $150+ per test. This is important bc we need inexpensive testing so people can opt to test as frequently as needed. Think schools, universities, essential workers, and those returning to their offices in the coming months.

👉most accurate of currently available saliva tests at about 90% accuracy. Take 2 tests in a row if you need to be sure and boost accuracy to 99%. Think about pregnancy tests: does anyone ever really take just one?

👉rapid turnaround time, with about 90 results processed in about 3 hours. Laboratory tests can be pooled for processing: think a whole class or office can be pooled into a single test & we'd only need to test individually if the pooled test comes up positive. Currently, swab tests are taking 5-7 days to get results. We haven't even started school yet, hit flu season, nor do we have high cases like other parts of the country.

👉 it's being studied with the NBA, one of the most frequently tested groups of individuals in the world.

More about SalivaDirect here: https://covidtrackerct.com/about-salivadirect/

What's all the Buzz about Convalescent Plasma?

Vaccine development is not the only effort science is racing to develop and evaluate as part of our toolkit against COVID19.

Four former FDA Commissioner's have collaborated on this piece highlighting the latest on the study of convalescent plasma: https://www.washingtonpost.com/opinions/2020/08/03/4-former-fda-commissioners-blood-plasma-might-be-covid-19-treatment-we-need/?utm_content=buffer634f9&utm_medium=social&utm_source=twitter

The basis behind convalescent plasma is to use the defense system of antibodies from a person who has recovered from COVID19 to boost the immune response of a newly infected person.

If you have recovered from COVID19, consider donating plasma: https://thefightisinus.org/en-us#home

Donated plasma may be used for 2 different powerful routes:

1) Direct transfusion to a patient critically ill with COVID19

2) Development of plasma derived therapy

Excellent graphic detailing these 2 routes here: https://thefightisinus.org/images/TwoPaths.pdf

The federal government’s ACTIV program, also part of Operation Warp Speed, is standing up trials of promising treatments, including convalescent plasma and synthetic antibodies that work through mechanisms similar to plasma to neutralize the virus. For more information on the details of COVID19 trials: https://www.nih.gov/research-training/medical-research-initiatives/activ