In this excerpt from their new book, two physicians dissect one of the most notorious failures to ‘do no harm’.
Doctors (and modern medicine) are generally held in high regard, yet you might be surprised to learn that much of the success of modern medicine is more apparent than real.
Most of the major advances in health and life expectancy over the past couple of hundred years weren’t due to modern medicine, but to public health, political and industrial achievements, such as clean water supply, sewerage separation, having enough food and avoiding war.
Medical care has not universally or consistently improved health or quality of life. There are, of course, highly successful medical therapies, such as chemotherapy for childhood leukaemias, which have saved lives; and hip replacement and cataract surgery, which have improved quality of life for millions. But many other medical interventions, despite having proven ineffective and even harmful, remain in common use. Astoundingly, it has been estimated that about one-third of medical care is of no value, while another 10 per cent is actually harmful.
While most people would agree that we should be cautious about introducing new medical advances into routine medical practice before they have been properly evaluated, we repeatedly fail to do so.
Although driven by the well-intentioned desire to pass on the presumed benefits to society that new advances in treatment promise, their rapid introduction into routine care often backfires.
Solving a non-existent issue: the opioid epidemic
Perhaps the strongest current example of how our best intentions have led to massive harm is the opioid epidemic. It has been most prominent in the United States, but has also affected Canada, Australia and Europe. It’s also ravaging the developing world, including India, Africa and the Middle East, in what the United Nations has dubbed the ‘other opioid crisis’, as it has generated far less publicity. This tragedy is an ‘iatrogenic’ epidemic, meaning it was caused by doctors and the medical system. It has been called the biggest mistake ever made in the history of modern medical pain management. These drugs were given with the best intention – to relieve pain – but the estimates of how effective they were, as well as their possible harms, were way off.
In the early 1990s, there was widespread concern that there was an epidemic of untreated acute pain in American hospitals. Studies were showing that emergency department nurses and others were significantly underestimating patients’ pain compared to patient self-report. By the middle of the decade, the American Pain Society had floated the idea that pain should be the fifth ‘vital sign’, essential information to be collected at every encounter with a patient, alongside the other vital signs of pulse rate, blood pressure, temperature and respiration (breathing) rate. This concept caught on rapidly, and the rating of a patient’s pain on a numerical scale became mandatory. At the same time, it became obligatory to treat the pain. No large studies were ever performed to determine whether the assessment of a person’s pain on a routine basis either improved pain assessment or significantly reduced patients’ pain levels.
While there were some early concerns about whether there was really a need to screen all patients for the presence of pain and whether this might lead to overuse of opioids, others made it a human rights issue. There was even a Global Day Against Pain campaign held in 2004 to promote pain relief as a human right. The measurement of pain became one of the ‘quality of care’ indicators used in the accreditation of hospitals, and rather than treating pain on an as-needed basis, treatment algorithms were developed to ensure pain would be ‘eliminated’. While it was well intentioned, making pain a vital sign has had profound unintended consequences.
Although doctors had traditionally been very cautious in their use of opioid analgesia (pain relief) for people with chronic non-cancer pain due to concerns about tolerance, dependence and addiction, the number of prescriptions for opioids in the United States started to increase on an annual basis from the early 1990s, and in the late 1990s it accelerated. Doctors were falsely reassured by weak evidence and industry claims that addiction rates were very low. In 1995 a new sustained-release longer-acting opioid called oxycodone (marketed as OxyContin) was approved by the US FDA for treating pain. The approved labelling stated that addiction from the drug was ‘very rare’ and the delayed absorption reduced the potential for abuse. These unsubstantiated claims weren’t removed until 2001.
In fact, the maker of the drug, Purdue Pharma, ensured that these claims were greatly reinforced, using paid expert doctors to speak on the subject. By 2012, 255 million prescriptions for opioids were being filled annually by US retail pharmacies, which equates to 81.3 prescriptions per 100 people. According to the US National Institute on Drug Abuse, data from 2018 indicated that more than 128 Americans were dying every day after overdosing on opioids, including prescription opioids, heroin and synthetic opioids such as fentanyl (also a prescribed medicine). According to the US Centers for Disease Control and Prevention, more than 42 000 Americans died from opioid overdose in 2016, the last year for which data are available.
About 2 million people are estimated to suffer from substance abuse disorders related to prescription opioids, while another half a million suffer from heroin addiction – there’s overlap in the use of these drugs. About a quarter of patients prescribed opioids for chronic pain misuse them. This means they might take them in a way other than prescribed, including in a higher dose, or they might take them to get high. About one in ten people prescribed opioids develop an opioid addiction, and about 80 per cent of people who use heroin first misused prescription opioids. There’s also no sign that this public health tragedy in the United States (or elsewhere) is abating – opioid overdoses continue to increase in most US states by more than 30 per cent annually and over 50 per cent in some large cities. In fact, while the US comprises just under 5 per cent of the world’s population, it uses more than 80 per cent of the world’s supply of opioids.
But this doesn’t mean other countries are immune. Australia saw a 15-fold increase in opioid dispensing between 1992 and 2012, and, as in the US, the increase has been greatest in regional and rural areas. This has been accompanied by an increase in prescription opioid deaths which now account for about a quarter of all drug-related deaths, about a third of which are due to fentanyl (which is 100 times stronger than morphine). While in the 1990s, heroin deaths were 2.5 times more common than prescription opioid deaths, the reverse is now true.
Over the years, Purdue Pharma has settled numerous US federal and state charges for millions of dollars. It has pleaded guilty to deceptively claiming that OxyContin is less addictive, less subject to misuse and less likely to cause dependence than other pain medicines; promoting off-label use of the drug; and deceptive marketing. In an effort to increase revenue after it had declined following a reformulation of the drug to make it more difficult to misuse, and with clear knowledge of its detrimental effects including many preventable opioid-related deaths, the company focused on marketing the drug to high-prescribing doctors. These doctors make up less than 7 per cent of all prescribers but prescribe more opioids than the other 93 per cent of doctors combined. The company provided kickbacks to the highest prescribers (almost US$500,000 in one case) as well as to pharmacies willing to fill prescriptions other pharmacies declined to fill, and also conspired with an electronic health records company to create alerts suggesting OxyContin in medical software.
The latest settlement, in October 2020, resulted in resolution of all current US federal criminal and civic charges against both Purdue Pharma and its owners, the Sackler family, after they were allowed to enter plea agreements. Only three company executives have ever been fined, while no member of the Sackler family has ever confessed to doing anything wrong.
So how did this all happen? Once pain was mandated as a vital sign, doctors were expected to ask patients if they had any pain. If any pain was reported, doctors were expected to prescribe treatment to either reduce the pain or eliminate it completely. And they conditioned patients to expect that this would occur.
At the same time, however, most clinicians lacked adequate knowledge about how to assess and manage pain. They didn’t recognise that for many people, prescribing opioids wasn’t the correct response. Yet prescribing opioids, and in high and escalating doses, became the mantra to alleviate pain and suffering. They had forgotten about ‘first, do no harm’.
As doctors, we’ve seen the effects in our day-to-day practices of this expectation that all pain must be eliminated. We regularly see patients who were prescribed opioids for an acute episode of pain, such as an injury, and it simply gets continued. After a short time, the patient finds they are irritable, in more pain, sometimes have nausea, and have difficulty sleeping if they stop taking the drug, so their doctor prescribes more, not realising that the symptoms are not from the original injury, but from the opioids themselves. Paradoxically, opioids are the cause and the cure for the problem of opioids, so they keep getting prescribed.
Perhaps the biggest twist in this tale of opioids is that the drugs aren’t all that effective in the first place for non-cancer pain. They often don’t relieve pain any more than other (non-opioid) drugs and they nearly all have terrible effects on people, both physically (drowsiness and constipation are very common) and psychologically. Seeing this problem in patients discharged after surgery, we conducted a blinded scientific study (a randomised controlled trial) comparing the usual, strong opioid (OxyContin) prescribed to patients at discharge from hospital following surgery, to a much milder type of opioid-plus-paracetamol drug, then available over the counter.
We gave patients either the OxyContin or the milder drug, and both were identically packaged, so they didn’t know which one they were taking. The study showed no difference in the levels of pain in the days and weeks following discharge, and no difference in the numbers of pills taken (patients were allowed to adjust the dose according to their pain). In fact, the only difference between these two groups of patients was that the rate of complications was much higher in the patients who took the stronger drug.
Why do we keep getting it so wrong?
A core problem, and the reason behind much of the excess in health care, lies in the mismatch between perceptions of the benefits and harms of medical care and their true effects. There’s considerable evidence that doctors’ estimates of the benefits of what they do aren’t accurate, they’re overestimated; while at the same time their estimates of the harms coming from what they do are also wrong – they’re underestimated.
We love our roles as doctors. We regularly experience the joy of healing – for example, by watching a fracture heal in good alignment after surgical fixation, or seeing a case of severe inflammatory arthritis resolve with modern drugs – and we want to preserve the trust we enjoy. We also want to make it clear that we believe that most, if not all doctors, are trying to help their patients, not harm them.
We haven’t set out to deliberately erode trust in doctors. Rather, our aim has been to bring knowledge of the problems with modern medicine to a wider audience in the hope that by understanding the problems, we can focus on what needs to change. We would like many more doctors (and patients) to experience that ‘joy of healing’ that comes from a more science-informed understanding of the true benefits of medicine and its true harms.
Rachelle Buchbinder is a physician specialising in rheumatology, Director of the Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology at Cabrini Hospital and a Professor of Clinical Epidemiology at Monash University.
Ian Harris is an orthopaedic surgeon at Liverpool, St George and Sutherland hospitals, Professor of Orthopaedic Surgery at UNSW Sydney.
Edited extract from Hippocrasy – How Doctors Are Betraying Their Oath, by Rachelle Buchbinder and Ian Harris, (NewSouth $32.99), out now.