Standard of care. It’s a phrase that gets tossed around a lot. Let me tell you a story about what it should not be, especially for a person in a drug research trial.
Before I begin, a note on my background. I grew up as the daughter of a clinician-researcher who is to this day, in his so-called retirement, in demand around the world, whose patients think he walks on water, and who has never in his entire academic career been denied a research grant (see my page on him, a bit outdated because I can’t keep up). During my university days, I used to talk to him a lot about research work, medical care, medical education. It never surprised me when he’d come home excited about some new research finding – and not just in his field or from research done by himself. His curiosity just about matched my own. I also wrote a book on Judy Taylor, the patient who launched his career into the stratosphere and who demanded all his skills as a researcher and physician to save her life and to give her good quality of life. So I know what good standard of care is.
I have a brain injury. Since the brain controls the entire body, mind, and emotions and since we know little about brain operations, caring for me is complex. But good standard of care even for someone like me is not.
I met a new specialist a little over six weeks ago. Seems like forever ago. He enrolled me immediately into a research study as he believed that the research drug would decrease my pain and so improve my sleep. I have pain from many sources, including fibromyalgia and the lingering effects of the seat belt injuries I sustained (again) in a three-impact car crash back in 2000 (the same crash that gave me my brain injury). The hypothesis made sense to me, and having conducted or been involved in a few research studies as the researcher, I was game to be the guinea pig for once. He sent me to his research team as they would instruct me. But he was in charge and would keep in touch with my progress through them. And I was given another appointment to see him end of May to follow up on all the tests and study results.
The first week was baseline week. Tedious but necessary. The second began the drug trial itself. I saw the research team each week as the dosage increased up to the highest dose. I have no idea what the highest dose is, or rather was. Every day I had to phone in a 24-hour diary on my pain, fatigue, and sleep. As I understand it now, the crucial parameter was my pain level over the previous 24 hours. Every evening when I took the drug, I had to fill in a paper diary, noting the time, which bottle(s), and when in relation to supper, snack, or breakfast. I was a good girl. I took my drug as instructed. Each weekly meeting was slightly different, but they always covered off two things: suicide ideation and/or actions and side effects. Apparently the suicide thing is de riguer for any drug, no matter how unlikely it was to cause suicide. I worried about it in the beginning, but as I got used to the process and the drug, I forgot about it.
Once I was stabilized on the highest dose, I went for three weeks without seeing them while still keeping all the diaries and taking the drug daily and wearing my Actiwatch, butt ugly thing that it was.
I wasn’t really feeling any different as the weeks went by. And then all of a sudden, things changed. But not the things the researchers were looking for. Problem number one for me.
They wanted to know about pain and sleep. But it wasn’t my pain and sleep that had changed dramatically, so dramatically that even my parents noticed. So dramatically that when I brought it up with my parents to discuss what I should do as today approached, they said categorically that I should not come off it. As I mentioned above, my father has conducted many research studies, many that involved his own patients. He knows the drill. He indicated that a patient knows when a drug is having an effect because it’s obvious to the patient. He’s seen and heard about it lots of times. Was it obvious to me? Yes. He indicated that his patients have been able to speak to him about what to do when they don’t want to come off it. And he explained the kinds of options available to someone like me when a drug is not commercially available.
So I called the specialist’s office last week to talk to him about the changes and about my options. Burgeoning problem number two for me.
The specialist wasn’t in. The specialist was busy. His assistant would let him know I’d called, and she suggested I try again on his patient day or I could fax a note. I’d learnt from previous experiences with others that faxing notes gets me nowhere. Physician reads it (maybe), files it, doesn’t talk to me. So I called again on his patient day. Gave my cell number. Ensured I was available to take his call anytime that day. No call. Friday I was at the hospital. I tried doing the really annoying ambush thing (but to be absolutely honest, another specialist had suggested it since time was ticking down) and asked him politely for two minutes to discuss what to do as I could not come off this drug Tuesday. The changes were too dramatic, too important to my quality of life. I didn’t get that far. He looked peeved and interrupted me. Well, okay maybe he was having a bad day and obviously stopping him in front of his office would not be the happiest moment of his life. But he hadn’t called me back.
Let’s talk about that for a moment. Physicians today do not call patients back because OHIP doesn’t pay them to. Medicare used to pay physicians and surgeons to telephone patients because the bean counters understood phone calls were part of patient care. But no longer. I had heard that if a patient initiates a call that OHIP will pay but don’t quote me on that. So if a physician calls a patient today they’re doing it pro bono, and they’re doing it because patient care is that important to them. To compare: lawyers don’t even talk to clients for five minutes sans billing them, and lawyers can have as big an effect, if sometimes not bigger, on a person’s life as a doctor can. However, I’m not just a patient, I’m a guinea pig. In a drug trial. For a drug that’s not commercially available. It doesn’t matter whether or not it’s derived from one that’s out in the marketplace, they still don’t know its full effect. Thus when a patient-guinea pig calls saying that there have been dramatic changes that have affected internal body functioning and cognition, it’s important from both a clinical and research point of view – and most of all for good patient care – to take the effing call.
He agreed to speak with me after his meeting. I stared at posters in the waiting room, made queries about an advertised non-drug research study (I need money), and was finally called in to “discuss” it with him. He’d spoken to the chief researcher about my changes – who, by the way, did not know about them all to say the least, but neither the researcher or the specialist knew that – and to his assistant – who also knew only some of the details – but he didn’t speak to me. And so he knew only part of the story because I was waiting to speak to him to tell him the discreet details. I didn’t feel like bandying them all over the place. I’d had enough of that during my insurance fight. The two people he spoke to were also unaware of my financial situation, and not being my physicians they didn’t understand how much this drug was changing my life. Problem number three; blew up in my face today.
After speaking to them about my situation and only them, he told me that I would be enrolled in the second half of the trial, that if I was enrolled in the placebo portion and after a couple of weeks didn’t feel too good, they’d discuss what to do about drug options then. It’s the best way. Bye. What about the changes? Have you seen them before? Bonus. Bye.
To recap: zero discussion with me, the primary source, about my pain levels, dramatic changes, staying on the drug, and taking and paying for its approximation.
Today, the computer told the researchers I was ineligible for the second half of the study. Big surprise. Well, it seemed to be for them. Not to me. I knew what my pain levels were. I knew that once I was no longer reminded of being in pain every verse end, I’d go back to my ignore-it-and-it-will-not-interfere-with-my-life attitude, which would not actually drop the pain levels in my diary entries enough for it to show that the drug had affected them, if you follow that. So I don’t know why they were so sure last week I’d remain in the trial. They could see my diary entries in real time, but I guess they’re not good ballparkers whereas numbers being my friend and having saved my ass many a time since my brain injury, I’d sensed it.
All of a sudden, they had to figure out how to meet my needs. They had to figure out how to get a prescription for a commercially available approximation of what I was one from the specialist. They said my pharmacist would explain to me how to take it. I said point blank how about discussing it with me now. I mean seriously, since when does a physician not discuss a prescription with their patient? They couldn’t, only the specialist could, and after awhile it became apparent, he would not be available for some time, like, hours and hours even though last week I’d received the impression he would be reachable. Well, what does it cost? Oh, no worries, insurance will cover it. I pointed out I didn’t have private insurance. Did the Ontario Drug Benefit Program or Trillium cover it? That threw them for a loop. I’d have to ask my pharmacist, they said. What do I do if I can’t afford it? Well, I was on the tapering dose since they couldn’t get me a prescription right away anyway, that would hold me for awhile. (Like, for barely a week. Maybe.)
So I trooped off to my pharmacy. The drug is not covered by any Ontario drug program for anyone at any dosage. It should be, maybe it will be, but it isn’t. What would it cost me? Well, that depends on the dosage. A bit of a problem there. The research team hadn’t told me the dosages of the research drug; had refused to discuss the prescription with me; the specialist had not yet written it; and I had no clue. So we played with some numbers. I thought about what I could give up after I heard the dollar figures. The pharmacist suggested asking for compassionate care or use whereby the pharmaceutical company would provide me the drug gratis. She explained that the specialist has to apply and how it would work in practical terms. Problem number four.
Last week I was upset, worried, stressed. This week I’m mad. This is how the problems that arose for me translate to bad standard of care:
Problem number one:
Bad or what-has-become-acceptable standard of care is that when a patient says they are experiencing changes different than what is expected – ignore them.
Good standard of care means that when a patient indicates that a drug is affecting them differently, you discuss it immediately, not at their next appointment time. You discuss it so that the patient first and foremost feels safe because a drug can be a dangerous thing and the patient needs to know the clinician researcher has their back. You discuss it also so that you can learn from it, think about how that patient differs from the other guinea pigs, and most importantly, how best to help the patient so as to maintain and maybe even improve on the good changes. The patient’s health is top priority.
Problem number two:
Bad or what-has-become-acceptable standard of care is that when a patient-guinea pig calls, you don’t return their call because it is protocol to speak to patients only during scheduled appointment times. Then be impatient with them when they do whatever they can to get your attention because they’re that desperate.
Good standard of care means that when a patient-guinea pig calls, you return their call as soon as possible because even good changes require immediate attention to ensure the patient is not hiding side effects or is not at risk of unforeseen consequences. And if they button-hole you because you didn’t call back after their repeated calls, realise it must be really important to their life and health and well-being for them to make that extra effort. You listen; you discuss; you reassure them.
Problem number three:
Bad or what-has-become-acceptable standard of care is that when a patient-guinea pig tells you that they don’t want to come off a research drug, you don’t discuss the financial details, figuring it’s their problem not yours or you’ll deal with it when you must.
Good standard of care means that when a patient-guinea pig tells you that they don’t want to come off a research drug, you discuss what is available and ask if they have insurance. You know all about how lack of money stops treatment; you’re aware if the drug is covered or not by the Ontario Drug Benefit Program or Trillium so that you don’t send them haring back and forth between the pharmacy and hospital just to figure out how to pay for it. Even better you’re willing to discuss these things over the phone. You appreciate it when a patient has given you notice so that both you and the patient have time to find out how the patient will pay and if they need you to fill out an application for compassionate care.
Problem number four:
Bad or what-has-become-acceptable standard of care is that you’ll be caught unawares by the patient’s need for financial help and refuse to discuss it outside of scheduled appointment times, long after the research drug has left their system and they have gone back to their sucky pre-drug quality of life. Stress them too so badly that no amount of Valium will relax them.
Good standard of care is that you’ll have discussed it when the patient called in advance of the study possibly ending and be ready to resolve this problem expeditiously, or if not, to be available when the patient needs to discuss what comes next, how it works from your point of view, how long it will take. In short, make the patient feel safe, assure them they have a partner in their care and are not alone, and that things will work out. Most important: shorten their time off the drug as much as possible.
To sum up: good standard of care is predicated on a physician being able to think laterally, vertically, diagonally (not relies on preconceived notions or guidelines based on the “average” patient), sees medicine as an art not strictly a science, sees the patient’s health as the highest priority, and appreciates a patient involved in their own care. One of these days I’ll receive good standard of care. But as of now I’m on the tapering dose.