A devastated Vince alleged that in the readiness to enrol him there had been a lack of informed consent about uncommon but serious toxicities. He thought that he had been given the fine print to read ‘but the spoken emphasis was on the good outcomes’. Subsequently, deficient communication with the principal researcher had led to his complaints not being taken seriously.
He lodged a formal complaint and received a modest financial compensation. The researcher was reprimanded, and the trial governance was strengthened. Vince died shortly afterwards, having lost his zest for life.
Vince’s story is not an argument against clinical trial participation but a reminder to understand our options fully and not hesitate to ask questions.
In recent times, a prominent Australian trial was retracted by the Journal of the American Medical Association, a full two years after publication, when it emerged that the principal researcher had concocted patients and fabricated data about a common blood pressure drug. Given the high prevalence of cardiovascular disease, the impact of a positive study in a prestigious journal is substantial and wide-reaching and this finding was quoted more than thirty times. Many doctors read the original conclusion and changed the way they managed patients but failed to see the retraction.
The story of promising trial results being retracted or unable to be replicated is all too common. Notorious retracted studies include one that claimed a link between the measles vaccine and autism, whose ripple effect continues to harm children who are not vaccinated. The author of an influential study on human cloning and stem cells was found dead soon after his findings were debunked as fabricated. Other fraudulent researchers have been barred from government funding, sometimes decades after their actions.
Most patients and doctors are unaware of the ugly underbelly of clinical trials, the practice of unscrupulous researchers and large pharmaceutical companies prioritising sales over patient welfare. Upstanding scientists rightly bristle at this broad generalisation and point out the greater good from well-conducted trials which advance the cause of all patients, but there is truth to both sides.
Finally, there is another important but invisible aspect of clinical trials that should matter to everyone: deception by volunteers who participate in paid studies. In a recent finding, a quarter of volunteers exaggerated their symptoms to qualify for a paid study and fourteen percent pretended to have a health condition in order to join the study. The latter would be difficult in the case of cancer but less so in trials studying pain, fatigue or anxiety.
By falsifying their account, participants undermine the integrity of the entire study by biasing the data. Whether a trial is studying the value of a test or the toxicity of a drug, participants who report their experience with anything less than total honesty can substantially alter findings, leading to the discontinuation of a valuable trial or conversely, continuation of an unsafe one. Serious toxicity can be attributed to the experimental medication when the culprit is an illicit drug or a drug interaction. Alternatively, a drug trial that mistakenly includes patients suffering from a given condition instead of healthy volunteers may be biased in favour of the drug.
Despite some of the obstacles associated with clinical trials, evidence is our best friend when it comes to selecting the most appropriate painkiller, the best chemotherapy, or the safest surgical technique.
Before recommending a clinical trial, doctors must consider if it is the right move for their most seriously ill patients. We must apply a ceaselessly enquiring mind to the reams of data thrust upon us every day and not be afraid to acknowledge that in many areas of medicine, there is no one right answer. Importantly, for patients, it means having a curious mind and being unafraid to ask questions. With the power imbalance between doctors and patients this isn’t easy but, more than ever, it’s necessary. Ironically, sometimes being ineligible for a trial provides the closure someone needs.
It’s human nature to want to explore every possible avenue of hope. When it comes to searching for a clinical trial towards the end of life, these considerations take on profound meaning. The stakes are higher when time is limited – many of us desire to cherish our time with family and friends but some people find satisfaction from pursuing treatments until the end of life. As long as we are fully informed, it is for each of us to decide what matters most.
Protecting our health
The first wealth is health.
Ralph Waldo Emerson
TWENTY YEARS OF EXPERIENCE in medicine has taught me that dying well has a necessary precedent, living well. And while living well doesn’t guarantee a good death, it definitely helps to guard against some of the complications that befall those who suffer from the so-called ‘lifestyle’ diseases that are on the rise.
I was quite fond of my patient Ron, who jokingly referred to himself as a couch potato although I could always sense his self-consciousness. Short and morbidly obese, Ron hated moving and loved to talk about his love of fat and sugar, preferably together. The first time we met he struggled to walk the short distance to my room before crashing into a chair and clutching its sides to regain his breath. I watched him with dismay because he was only in his mid-fifties.
I’d told Ron when I met him that his cancer was inoperable but there was a good chance of inducing a remission with chemotherapy. However, I knew that his poor fitness would hamper his ability to cope with intensive therapy.
Patients with obesity, uncontrolled diabetes, poor cardiovascular fitness, excessive alcohol and cigarette consumption and other chronic diseases experience a significantly higher risk of complications and death. Even ordinary setbacks take on heavy meaning and it can be extremely challenging to guide such patients back to health.
Ron joked that he’d try not to be my ‘nightmare’ patient but his wife, Sue, looked worried. One week before starting chemotherapy, Ron developed pneumonia. He responded to antibiotics but even I was surprised by how quickly he became deconditioned. The effort of walking to the bathroom exhausted him and he needed a hand to get out of bed. Sent to rehabilitation, he developed a urinary tract infection there and nearly died from sepsis. But he rallied and must have seen the relief written all over my face. When every week mattered, there was no room for delay.
With a marathon effort, Ron got home, began chemotherapy, and survived the first month. But just as I relaxed, he landed in hospital with a bowel obstruction and I dreaded what would surely follow. He was prescribed pain relief and started on artificial nutrition to help rest his bowel, but his poor general health meant he had no reserve left.
Some days later, his surgeon called me to share her dilemma over the obstinate bowel obstruction. She felt he would die without an operation but had an equal risk of dying as a result of the operation. The decision about what to do had to involve us all and, most of all, the deteriorating patient.
Despite his obvious unwellness, I was touched by Ron’s usual good humour. People kept entering his room to adjust his intravenous lines, monitor his vital signs and check on his comfort – he raised his hand to acknowledge each one. I sat down next to him and told him we needed to talk. Drawing a picture to illustrate his predicament, I told him I’d understand his decision to have surgery but would support him unequivocally if he chose to avoid surgery and be palliated. No matter how many times I have this conversation, it never feels easy, but by now I have learnt its value.
Ron decided to take a chance at surgery. He hugged me for supporting him and I felt glum at our last good exchange. I couldn’t help thinking of his surgeon and the emotional toll of such a risky undertaking for the entire surgical team.
Thanks to modern anaesthetics and a skilled team, Ron’s blockage was cleared and he survived the surgery. However, he developed another infection and this time failed to regain consciousness. Three days later, with the writing on the wall, his heartbroken wife made the decision to withdraw intensive care. I visited Ron with enormous regret shortly before he died. His many tubes had been removed and the machines surroun
ding him had fallen silent. He looked grey and had suddenly aged many years, but flanked by his family, I thought he appeared more restful than in all the time I had known him.
While the ultimate cause of Ron’s death was cancer, his dismal state of fitness had caused his untimely death. Not for the first time, I thought about how little people understand the deadly impact of the benign-sounding term ‘lifestyle factors’.
A growing body of evidence supports the role of lifestyle modifications in preventing chronic illness. For instance, reflecting on the untold grief and heartache that cancer causes, researchers recently found that that even small improvements in our lifestyle have the potential to translate into important health gains. Nearly forty per cent of cancers are thought to be preventable. Of course, there are many other causes of ill health we ought to be concerned about, not only cancer. Silent diseases that shorten our lives and that the majority of us will experience, either for ourselves or through our loved ones, include heart disease, diabetes, organ failure and dementia.
Some lifestyle risk factors are modifiable, which means we can reduce our personal risk, and others are fixed, such as age, gender, race and family history. We have the power to reduce the risk of developing chronic disease by making better dietary choices, eating a little less, moving a little more, not smoking, curbing alcohol and maintaining a healthy weight. Fostering close relationships and safeguarding our emotional health are other important aspects of living well. All this might make for a tough prescription, but health clinics and hospitals are overflowing with people who face the serious impact of having neglected their health.
In hospitals that are the seat of so much bad news, one instantly uplifting thing is to meet ninety-year-old patients – and even some centenarians – in better health than people half their age. Doctors and nurses marvel at their well-being and good-naturedly enquire about their secret. I note some broad attributes in such patients: they have usually avoided smoking, used alcohol with restraint, and have maintained a healthy weight through a balanced diet and exercise. They’ve adjusted their expectations with age, remained socially engaged and found a different purpose with passing years. This contentment is infectious. When their health deteriorates, many die peacefully and their loved ones describe a quiet sense of closure. Of course, not every death is the same and there can be surprise, grief and controversy at all ages. But being a doctor at the end of life is to be reminded of the relationship between living well and dying peacefully.
We cannot control every aspect of our life but on top of our list ought to be our physical health and emotional well-being. Our death may be inevitable, but we have a role in making our lives better and longer. There are abundant guidelines on weight management, safe alcohol consumption and how to stop smoking, and many of us have access to public space for exercise. These changes need not be expensive or complicated, or require a professional; they simply require us to acknowledge that the cost of making these changes pales in comparison to that of dealing with a chronically poor quality of life.
We all know people who pledge to change their behaviour in response to a wake-up call. It’s far better to benefit from the experience of others and protect our health from the outset. As an old saying goes, he who has health has hope; he who has hope has everything.
Tackling pain at the end of life
Do not mock a pain you have not endured.
The Quran
‘SO, YOU’RE SAYING there is nothing you can do.’
‘That’s not what I said,’ I gently reminded Milos. ‘Chemotherapy will be harmful, but I want to treat your pain.’
‘But without chemo, I’ll die.’
Perhaps the most common conversation I have with patients in the last phase of their life is whether forgoing treatment equates to giving up, and hence inviting premature death. In fact, this couldn’t be further from the truth. In most cases, aggressive interventions at the end of life are known to do more harm than good and can lead to a poorer quality of life and potentially reduced survival.
‘I’m afraid you’re too unwell for chemotherapy, though reducing your pain is a good goal.’
At eighty-eight, Milos was frail and worn-out merely from the effort of walking to my room. Small-statured, bony and painfully thin, it seemed a gust of wind might tilt his balance were it not for his sturdy walking frame. He was so desperate to have more treatment that I felt I had but one chance to convince him otherwise. It’s easy to extinguish the flickering hope of dying patients but it will never be more important to care about their holistic needs.
As he looked at me sceptically, I feared I’d lost. I watched him squirming in his chair, brusquely downplaying his pain, noticing how people tried to disguise their discomfort to protect their loved ones and present their best side to the doctor.
His daughter looked upset, having seen his desperation and sensed my caution. She explained that he couldn’t fathom having an incurable illness and I sympathised that, while I couldn’t alter its prognosis, I could confidently ease his symptoms.
‘Let me prescribe you a small dose of morphine,’ I suggested.
He recoiled in horror. ‘Oh no, I’m not touching morphine!’
His daughter’s face filled with consternation, as if the mention of morphine had made the news even worse.
I reassured them that morphine and related opioids weren’t simply used at the very end of life; they could also ease pain and improve quality of life, helping people function better.
At this, Milos fretted that he didn’t want to become an ‘addict’ and I quickly moved to dismantle a misconception that might compromise his eventual end-of-life care.
I differentiated opioid abuse from its judicious use to relieve severe pain. He listened attentively but without conviction, so I left the door open for discussion and his daughter agreed to update me. Just days later, she rang a nurse to explain that Milos was at crisis point and, this time, too despondent and fed up to protest at having morphine.
Within two days, his pain had receded, and he was sleeping without interruption, reducing his irritability and improving his appetite. Relief from the constant pain of the past several weeks made for lucid thoughts and he accepted a home visit from palliative care. I was gratified to note that a patient who had until recently disavowed all supports quickly accepted all advocacy. The palliative care team monitored his comfort, counselled his wife, and became a reassuring presence in the family’s life. On subsequent hospital visits, Milos never referred to chemotherapy again but often mentioned his gratitude at being largely free of pain.
His situation fragile but stable, Milos could venture into his garden, which lifted his spirits. His wife was especially happy at this and I found myself thinking that no other treatment could have brought greater relief than a small dose of morphine. This is why the World Health Organisation lists morphine on the essential drugs list for end-of-life care.
As his illness advanced, so did the need for higher doses of morphine, which created the added effects of constipation and drowsiness. But knowing what to expect made it easier to deal with these symptoms.
Milos lived for three months after his diagnosis. He died comfortably, surrounded by his wife, children and grandchildren, as he had hoped.
PAIN IS A UNIVERSALLY feared symptom at the end of life. Many people find the courage to ask if they will experience pain, others worry but are too afraid to say anything. This is why I believe that professionals have a duty to specifically address it and caregivers must be attuned to pain.
I reassure my patients that there are many ways to relieve pain, depending on its location, frequency and available resources. Unfortunately, large parts of the world lack access to pain relief but, elsewhere too, pain relief is often hampered by a lack of recognition, deficient expertise and widely prevalent misconceptions. As someone who prescribes opioids nearly every day, I have acquired a healthy respect for their efficacy as well as their dangers. Here are some practical tips everyone should know
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Opioids shouldn’t be vilified. Morphine is virtually irreplaceable in situations of severe burns, postoperative recovery, cancer pain and palliative care but there is good evidence that it provides no additional benefit over simple drugs like paracetamol and ibuprofen when taken for migraines, back pain, arthritis and other conditions associated with chronic pain. The opioid epidemic has been fuelled by the inappropriate use of opioids, which researchers now recognise can worsen the experience of pain and even prove fatal. When it comes to dying with comfort, however, morphine can be invaluable.
Some of my terminally ill patients report being allergic to morphine. On closer questioning, they have usually experienced nausea, vomiting or drowsiness after taking the drug in an emergency or after surgery.
These symptoms rarely point to a true allergy and may not be necessarily related to the drug. Since morphine can make an indisputable difference to quality of life, it’s important for patients to recall a thorough history of morphine use. Now that opioids are available in many different types and formulations, it’s almost always possible to help patients derive their benefit while being spared the side effects. The need for painkillers can fluctuate and many people must try different opioids before finding one that suits. It’s also important to ensure a sufficient supply of opioids to avoid the stress of suddenly running out and a relationship with the family doctor is important in ensuring up-to-date scripts.
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