I was at a trade show when Stacey called me back. She’s a nurse who I met though mutual appreciation of music, and who had lost her mother earlier in the year. My Mom wasn’t doing well, and had already lost 40 pounds between March and July, and she had spent the summer trying to get a University to accept her for an experimental drug trial. The University decided not to participate in the trial, and her doctor didn’t know how to obtain the drug, even though he had been a doctor for over 40 years.
I said I would help, but my career was now in business, and I really didn’t know what to do. So I reached out to Stacey because I knew she was a nurse who specialized in oncology, and had maybe heard of this experimental drug, Palbociclib. I couldn’t pronounce it any better than I could remember that it was designed to treat ER-positive, HER2-negative breast cancer, which was my Mom’s condition. But, this was complicated by lymphoma that was diagnosed a year prior, signs of potential bone cancer, and by Colon Cancer that had been detected in March of that year. Stage 4 Colon Cancer.
I was standing outside a trade show social reception when she said “Andy, I really think the best thing for your Mom to consider is hospice.”
The reality of that word hits you like a truck. I explained to Stacey that earlier in the summer, I had pleaded with my parents to consider just stopping all of the pharmaceuticals for just a week, just to see if her appetite improved. But the reaction was strong – they felt the drugs were what was keeping her alive. And, my Dad suggested that it would equate to giving up – and my Mom was a fighter.
There was something in Stacey’s voice. The calm, the directness, and the compassion that is both in the tone and choice of words. And, knowing what Stacey had just gone through, I knew and trusted that she was right.
But, this wasn’t my decision. My mission, at the moment, was to consider the promise or potential of the drug and seek out information to determine how it could be obtained because that is what my Mom wanted. Her doctor was convinced that if it was combined with the other drug she was taking, it could extend her life up to 20 months.
I did my research online. While the drug was currently in a Phase 2 study, I was surprised to find out that this was only tested on 179 people. While the drug did show promise of extending life, once you looked at the statistical graphs, you could see that it was a bell curve, with 20 months being the peak in the middle. But, there were people who died after a month, and others who lived 36 months. But, even that wasn’t definitive, because the origination was only a little more than 36 months prior – meaning some of them were still alive.
But, what really stuck out was the fact that those who took no drug at all (placebo) had a similar bell curve. Palbociclib simply pushed that bell curve out a little bit. But, by no means did it promise to give anyone 20 extra months of life.
Between March and July, my Mom was slowly eliminating foods one by one, to see what would bring her relief from the progression of the Colon cancer. By August, all food had been eliminated, and her doctor was recommending that she simply drink high-calorie protein shakes.
A close friend of ours worked for a Pharmaceutical Company that made ones that were 600 calories per 8oz shake, but had the consistency of pancake batter. She got us a few complimentary cases and had them shipped to my parents. I think that’s something often missed – within these companies are most certainly compassionate individuals who know better than most what patients are going through. And, when there’s a good-will opportunity, they actually go out of their way. It’s under-reported, and under-appreciated.
But, no matter what she did, the severe digestive issues persisted. She was suffering every day, and the choice seemed to be to live with the side effects of the drugs that were supposed to extend her life. It’s a question many before us have wrung their proverbial hands over – quantity over quality?
When my Mom finally came to me and asked for help, she said that the University had been considering participating in the Phase 2 study for 3 months. A week later, she got a letter saying that they simply didn’t have the resources to comply with the FDA study. They told her to find an ombudsman at the hospital.
That turned out to be a stumper.
When I called Swedish Covenant Hospital, the hospital nearest to my parents, the guy on the phone answered like he was one of Da Bears guys. I asked him for the Ombudsman, and he was like “I dunno no if we got one of dem. What’s they supposed to do?”
Fortunately, I got transferred to someone who gave me an education. Basically, that’s a word that describes what they now label Patient Advocates. Many hospitals now have staff who are not doctors or nurses, but administrative professionals who do the bureaucratic legwork that involves making calls, sending faxes or letters, and doing all of the mundane things that fall outside of regular medical practice.
The problem was that my Mom’s doctor was not actually affiliated with any hospital group. He was an independent doctor, who was 79 years old, and who got his education and experience in a different era. He was supported by two assistants, also in their 70s, but they spent most of their days dealing with a never-ending stream of people that often waited weeks for their appointments with them. Even if they had the experience, they didn’t have the time to take on the extra tasks.
I quickly realized that since the University and Doctor were not able to take on the task of applying for an experimental drug, that I’d have to step up and become a Patient Advocate myself. It wasn’t what I imagined I’d be doing, but I couldn’t deny my skills and talents were a fit. Regardless, I knew it was something I had to do.
I was able to make contact with a Cancer center in Northern Illinois that had some wonderful people who explained the job to me. I’d have to work with the company that produced the drug, Pfizer, and the FDA. The doctor would be required to fill out forms, write a letter, and in general recommend that the potential benefits of this new drug outweighed the risks to deliver a positive patient outcome.
This was a test for me. I can be triggered into anger by incompetence and approaching deadlines. Not to mention ignorance and stupidity. I had done years of work to keep my emotions suppressed, and my focus on the goal at hand. But this required working with an industry I despised, and a government I did not trust, and an agency of that government that I felt was corrupted by the industry I despised.
When I called Pfizer, the first hurdle was getting the form. The doctor had to request it. I wasn’t allowed to get the copy and give it to him. I had to get the doctor to actually call in to the company to make a direct request for the blank form. It wasn’t available online, and even if there was a leak, Pfizer would not accept the submission from the doctor unless they had previously received the request from the doctor for the form.
This, in turn, required the doctor, who already had a schedule with patents that went from early morning to early evening every business day, but that didn’t actually allow him to have any business hour breaks to make this call. And his two assistants weren’t allowed to do it on his behalf. It took about 2 weeks for those stars to align, and get Pfizer to send the form.
After another 2 weeks, I was calling the doctor’s office daily asking when the form would be filled out. It was only 2 pages long, I learned later, but no one would let me see a copy, or even help fill it out. We had to be patient with the patient, and they certainly knew the urgency and suffering that was going on with my Mom.
Once the form was submitted to the FDA, I then had to work with two people there – Alice and Molly. Some will appreciate the coded humor and irony. They were both responsive, articulate, and kind.
But, my Mom’s condition was getting more desperate by the day. She continued to lose weight, and cocktail of 19 other pharmaceuticals was creating other health oscillations from all their side effects. I urged Alice and Molly to help expedite the process – and they did.
In fact, Alice taught me about the emergency process for approval from the FDA that could, if necessary, give immediate approval by phone. It’s called the Emergency Compassionate Use Act, and is statutory. I wrote to the FDA:
“Her doctor, has deemed my Mother’s condition to be urgent enough to make contact directly, while the formal application is being submitted today. Our understanding of CFR – Code of Federal Regulations Title 21, Part 312.310 makes Kathleen a qualified individual patient:
She meets the Criteria required in 312.305(a), and her physician has determined the probably risk is not greater than the probable risk of the disease/condition. She also is unable to obtain the drug under the existing IND available programs, having most recently attempted to get Northwestern University to participate in the study. They told her that it would be more than a year before they would consider the study, which is likely beyond her timeline.
Under Section 312.310 (d) Emergency Procedures, we are given the option to have the Doctor contact the FDA for approval of immediate dispersement of Palbociclib so that Kathleen can start taking the drug as soon as possible. I would like to coordinate the communications to facilitate this approval as quickly as possible. If this can be done by email, phone, or fax, please advise as to the method that will be convenient to the Doctor, as well as be expedient in regards to any processes at the FDA or Pfizer, the manufacturer of the drug.”
Alice called me the night I sent the email, long after she had gone home from work. She called me from her cell phone, and didn’t block the number. She gave me advice on how to talk to Pfizer. She could have been a relative. The compassion was clear and evident, and was coming from a stranger working for the Government.
I followed that advice, and called the gentleman at Pfizer, and it took a couple days to get him on the phone. I overcame every objection, in some cases having to cite the law and educate him on why the normal month delay for dispersal should be expedited to immediate. He eventually dropped his guard, and started to relate to me on a human level. I could tell he cared, but needed to make sure we followed the regulations properly, which I made sure he knew I respected.
And, they eventually complied. My Mom got palbociclib, and we all celebrated overcoming the obstacle that appeared to be overwhelming. My Mom and Dad treated me like I was a hero, but I refused to think I did anything more than any good Patient Advocate would do. I knew this because several of them helped me informally join their ranks. And, I knew I was just a beginner, humbled by those that do this day after day, for many people the don’t know, and in some cases, never meet face-to-face.
Those are the true heroes. And, they probably never get the appropriate gratitude.
The celebration, however, was short-lived.
My Mom only only took the drug for 3 weeks before she was rushed to the hospital on Thanksgiving Day, dehydrated from all the pharmaceuticals, and complicated by an ulcerative esophagus that was mis-diagnosed as thrush. The anti-biotics prescribed pushed her over the edge. It exacerbated the digestive issues, and accelerated her dehydration.
A week later, at a family meeting, the doctors recommended hospice – only 3 months after my friend Stacey had recommended the same thing.
The reaction from our family was to be expected. Hospice equates to mean “you’ve got a few days”. I drove 1000 miles on a pot of coffee, and a parade of everyone visited my Mom to say their last goodbyes. None of us thought she’d last more than a week. I had my suit with me in case it was the precursor to a wake and funeral.
We spent a week looking at other options, but there really weren’t any. One by one, we all came to terms, and on December 16, my Mom was admitted to in-patient hospice care. To our surprise, she suddenly started to improve in her condition, and just 4 days later, they were looking to discharge her to at-home hospice care.
Over the next months, and then a year, and then 17 months in all, my Mom was treated by some of the most compassionate people I have ever met. Absolute angels whose first priority was the comfort of both my Mom and Dad. And, my Mom’s condition actually improved dramatically. She never regained the weight lost during the prior year, but she had good says that countered the bad days.
We got to celebrate a Valentine’s Day, Mother’s Day, and I got to celebrate my birthday with her. Then her birthday. And, then my Sister’s wedding, which was by all accounts, miraculous given where we were a year prior.
Then another Thanksgiving and Christmas. And Valentine’s Day.
The last time I saw my Mom was on Mother’s Day, 2016. It was fully 17 months after entering hospice, and almost exactly 20 months after we had chased the promise of an experimental drug.
When I looked back over this period of time, I realize that whatever opinions I had held that were negative about those who work in healthcare as a stereotype could no longer be sustained. While I am certain there are people that do their job poorly, we definitely had the good fortune of meeting dozens of healthcare practitioners that demonstrated compassion that you could see in their eyes, and hear in their voices when that wasn’t possible.
I went from considering all of the people to be adversaries who were part of this failed system, to being the partners in advocacy that worked like salmon swimming upstream in a system that they had neither created nor defended. It was simply the medium in which their compassion was delivered, flawed as it was. All doubt in my mind was erased that within this system were people who cared about people more than they cared about money.
And, I realized, more than anything, by becoming a patient advocate, I had, for better or worse, become part of that system myself. My training is not to be compared, but my compassion is and was shared. While they have skills I do not, I bring to the table something that they may not have the time, inclination, or knowledge to do on their own.
As for the people at the FDA, who could be argued are government regulators who are a drag on the system, were an absolute pleasure to work with. They went out of their way to go above and beyond. For whatever the organization gets wrong as a whole, the words and actions of the two I worked with more than balanced the downside.
I am grateful to everyone of these people, and as we had into another period of attempted reformation of a system that causes so much anxiety and grief, I can tell you that my experiences give me the energy to fight for every one of these folks who do so much for so many every single day. They earned by respect, admiration, and loyalty.
I can’t imagine having this attitude or approach the first time around. And, I truly hope that by sharing my experience that it has the chance of helping someone else change their mind and attitude about those who work in healthcare as well.
In fact, maybe that’s the best place to start – if you want to participate in the process of repealing, replacing, or repairing the ACA, then a good place to start is by spending a little time being an advocate for a patient in need. Get to know how the process affects them, the costs that stress them, and how sometimes, just a smile while looking them in the eye while saying “How can I help?” is all that’s needed to help make their day just a little easier.
Maybe, if we all became patient advocates to a degree, we could stop fighting over the lesser details. Because, really, what is the purpose of healthcare anyways?