Too much of a good thing

In the article below, Dr Ray Moynihan explores some of the reasons why tackling the complex problem of too much medicine remains a big priority in the COVID era.

This article is published as part of the TOO MUCH of a Good Thing series, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration between Wiser Healthcare and Croakey.

To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.

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Ray Moynihan writes:

A couple of weeks back, in the midst of the global pandemonium, there was one particularly surreal moment. A colleague had emailed me about a new opportunity to apply for research funding.

Nothing out of the ordinary there. As an academic researcher, those opportunities are my bread and butter, and they always generate great interest. This call for research proposals though turned out to be truly extraordinary.

While thousands were dying, health systems were flailing and economies folding, Britain’s biggest medical research funding body had released a new call for research titled “reducing overtreatment.”

More specifically the National Institutes for Health Research was calling for proposals to study “the evaluation of strategies and interventions to identify and de-intensify overtreatment.”

An initial reaction

As someone deeply engaged for a long time with the problem of too much medicine, my initial reaction was unexpected. The call for research on overtreatment somehow felt wrong. It seemed like a disrespectful distraction from the urgent need to respond to the pandemic.

Surely this was not the time to be worrying about medical excess. Perhaps anticipating reactions like mine, the funding body had a strong disclaimer up-front.

It stressed that COVID-19 research “should always be the priority” at this time. But then went on to explain that the new call was part of a wider plan “to keep the future research pipeline healthy.”

On further reflection there are of course very strong reasons to continue to investigate and tackle medical excess. Much has changed in recent months.

Yet as with the climate crisis, the facts about too much medicine remain the same. There are reliable estimates, from the United States  and from the OECD, that around one in five dollars spent on healthcare is wasted, including on unnecessary tests, diagnoses and treatments.

The problem with overdiagnosis

A key driver of the problem of too much medicine is overdiagnosis, which happens when people receive an unnecessary diagnosis, defined as a diagnosis that will cause them more harm than good.

New Australian research from early 2020 estimates a whopping one in five major cancers may be overdiagnosed cancers.

In other words, those cancers would not have gone on to cause the person diagnosed any harm if they were left undetected. According to that paper – published in the Medical Journal of Australia – around 29 000 Australians may be overdiagnosed with these cancers every year.

Most of them will also be treated unnecessarily, so they will suffer untold harms from the anxiety of a frightening label, as well as the complications of invasive tests and treatments.

The epidemic of unnecessary care

Just last month, as the COVID lock downs took hold in many places, authors of an article in the New England Journal of Medicine reminded us of the epidemic of unnecessary care caused by screening healthy men for prostate cancer, using the PSA test.

“PSA screening represents a textbook case of overdiagnosis and overtreatment in medical care” they wrote.

As they explained, in recent decades in the United States, alongside the many men who have benefited from a screening test picking up a deadly cancer early, “more than a million men were diagnosed with a clinically insignificant ‘cancer’ and received treatment for pathologic findings not destined to cause symptoms or death.”

Alongside the incalculable harm to individuals there is also the massive costs of this problem to health systems. Yet to be calculated in Australia, one estimate from the United States suggested the overdiagnosis of breast cancer alone was costing that nation US$1.2 billion a year.

If you add in the costs from false positives from breast cancer screening, the figure is US $4 billion annually.

And apart from the harm to individuals and costs to health systems, too much medicine is also clearly contributing to excess greenhouse gases, helping to fuel the climate crisis.

Determining harms and costs

There are strong indications that overdiagnosis and overtreatment occurs across many conditions, way beyond cancers. One of the world’s oldest and most prestigious medical journals, The BMJ, is running an on-going campaign to tackle Too Much Medicine.

The campaign has a focus on raising awareness about the problem of overdiagnosis, across a wide range of conditions, from ADHD to gestational diabetes, from osteoporosis to polycystic ovary syndrome.

Often overdiagnosis occurs because definitions of disease have been expanded so much that many healthy people are labelled as sick.

Determining the extent of harms and costs from the overdiagnosis of cancer, and non-cancer conditions, remains a major research question, which will take years to properly answer.

Perhaps more importantly, we also need research to determine the best strategies to wind back all this harmful excess and try to redirect the wasted resources to genuine unmet need.

Thanks in large part to several research grants from the National Health and Medical Research Council, Australia is now at the forefront of research on overdiagnosis internationally.

It was Australia which initiated a new global scientific conference on overdiagnosis, which has become the key forum for discussing the science of the problem and its solutions.

The 8^th Preventing Overdiagnosis conference is scheduled to go ahead at Oxford University in September this year, with a special theme on healthcare post-COVID.

A win-win situation

A lack of effective treatments is obviously a huge and on-going challenge in managing COVID-19 right now. But it’s already clear that medical excess is simultaneously a concern, when poorly evaluated, ineffective or dangerous treatments are widely promoted.

More profoundly, as the world seeks ways to fund the extraordinary costs of responding to the pandemic, tackling medical excess may offer a win-win-win situation.

Effectively reducing overdiagnosis and overuse can decrease harm to people, save money for health systems, and wind back healthcare’s contribution to the climate crisis.

Britain’s special call for research on how to reduce overtreatment is perhaps more relevant now than ever.

Dr Ray Moynihan is an Assistant Professor at Bond University’s Institute for Evidence-Based Healthcare, and an NHMRC Early Career Fellow researching overdiagnosis. As a journalist and author, he has published 4 books on the business of medicine.

We hear increasingly about the importance of tackling overtreatment, but less often about how overtreatment plays out in the lives of patients and their families.

In the article below, Brooke Nickel describes how the use of the word ‘cancer’ can lead to so many issues for people affected, and how it is time to re-think its use.

This article is published as part of the TOO MUCH of a Good Thing series, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration between Wiser Healthcare and Croakey.

To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.

Brooke Nickel writes:

No medical diagnosis has historically evoked such universal fear as ‘cancer’. For decades the word cancer has mostly been associated with intense illness and death. This has been further ingrained in society by public health messaging that cancer screening saves lives, coupled with images of cancer patients undergoing chemotherapy and stories of loved ones struggling with the disease. The clinical definition of cancer underpins this image by describing a disease that, if left untreated, will grow relentlessly and spread to other organs, killing the host. For some, this is the unfortunate reality. However, over the past few decades, our understanding and knowledge of cancer have progressed.

Now, the evidence indicates that some low risk cancers are non-growing or so slow growing that they will never cause harm if undetected and untreated. The strongest evidence for this has been shown in localised prostate cancer, low grade ductal carcinoma in situ (DCIS) of the breast, and low risk papillary thyroid cancer. Evidence has also begun to emerge in melanoma in situ, small lung cancer and certain small kidney cancers. Recent evidence estimates that 1 in 5 major cancers in Australia may have been overdiagnosed between 1982 and 2012. The consequence of overdiagnosing low risk cancer is that the diagnosis can cause more harm than good, through unnecessary stress and anxiety to individuals and their families, unnecessary side-effects associated with surgery or radiation and unnecessary medical costs.

Active surveillance as an option

Given the harms of overdiagnosis and overtreatment of these low risk cancers, active surveillance is now recognised as a safe and effective management option for some cancers. Active surveillance consists of closely monitoring the person affected and only providing treatment if there are changes in test results that show the cancer is getting worse. In localised prostate cancer, active surveillance has been a recommended management option for many years, and in low risk papillary thyroid cancer active surveillance has recently been recommended for very low risk tumours. Trials are currently being conducted across the world to assess active surveillance in low grade DCIS (here, here and here).

Although active surveillance and other more conservative treatments are recommended for the management of some cancers, people have a strong perception that aggressive immediate treatments are always required. It has been shown that the majority of men with localised prostate cancer still prefer radical prostatectomy or radiation therapy, rather than active surveillance to manage their diagnosis. Similarly, in DCIS it has been shown that women are increasingly opting for more aggressive treatments such as mastectomy and bilateral mastectomy rather than lumpectomy, even though these treatments do not improve breast cancer-specific survival.

Assumption that surgery is best

The label ‘cancer’ may make it harder for clinicians to recommend, and for patients to choose, active surveillance as a management option because of an overall strong fear of cancer and the longstanding assumption that aggressive surgery is the best treatment option. This has led to experts in the cancer community to question the label ‘cancer’. Otis W. Brawley, former chief medical officer of the American Cancer Society, has been quoted saying that: “We need a 21st-century definition of cancer instead of a 19th-century definition of cancer, which is what we’ve been using.” Furthermore, the World Health Organisation (WHO) currently states “there is an urgent need to integrate [new understanding of cancer] into cancer classifications internationally.”

Over the past five years our research group has tried to understand how the label ‘cancer’ may impact patients’ experience of diagnosis, psychological outcomes, and, importantly, treatment preferences in the context of the low risk cancers which may never cause harm. Our qualitative work has shown that some patients with very low risk papillary thyroid cancer describe being constantly worried after their diagnosis and treatment, and report continuously thinking that they are going to die. We have also found that patients report wide-ranging quality of life issues related to their diagnosis and treatment across physical, psychological and lifestyle domains. We have conducted a systematic review and two experimental studies (here and here) which demonstrated that use of the label ‘cancer’ in reporting a patients diagnosis (compare to a non-cancer label), significantly increased preferences for invasive surgery as treatment compared to active surveillance, and also significantly raised levels of anxiety, and willingness to accept more side-effects and harms from treatment.

Re-naming low risk cancers

We recently wrote an analysis article in The BMJ which collated some of the above evidence and proposed renaming and re-classifying low risk cancers for which there is evidence of overdiagnosis and calls from international experts to change the terminology and definition of cancer. Historically, there are some precedents for removing the label ‘cancer’ and re-classifying conditions where tumours have clearly been shown to be indolent and unlikely to cause harm. These include in 1998 in low risk bladder cancer, in 2001 in low grade cervical cancer cells, and more recently in 2016 for a variant of papillary thyroid cancer.

While a system-wide change for a number of other low risk cancers has and will create controversy, and will take time, we are now trying to understand what the community thinks of the idea of renaming and reclassifying low risk cancers by conducting community juries (a deliberative democratic method). We are also trying to work with pathologists to understand and consider re-calibrating diagnostic thresholds and/or alternative labels for low risk cancers.

There is no easy solution, so for now we should all be aware that for some the label ‘cancer’ may be doing more harm than good.

Dr Brooke Nickel is a Postdoctoral Research Fellow in The University of Sydney School of Public Health. Her research focuses on understanding the psychosocial impact of cancer diagnosis and treatment, and how to improve cancer communication and decision making.

We all understand the role of clinical trials in testing new medicines but many people would  be surprised to find out that there are different regulatory processes in place for the introduction of new medical devices and surgical techniques and procedures.

This can mean that the evidence-base for these components of health care is less than those for medicines and therefore there is potential for them to cause unnecessary harm.

Below Professor Ian Harris, Professor of Orthopaedic Surgery at UNSW, discusses the problems with the current regulatory environment and suggests changes to improve the safety and quality use of devices and surgery.

This article is published as part of the TOO MUCH of a Good Thing series, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration between Wiser Healthcare and Croakey.

To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.

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Ian Harris writes:

Most people have some idea of the rigorous testing that is required for any drug to be accepted for clinical use and government reimbursement: the drug must be compared to other drugs or a placebo in a rigorous scientific trial in terms of potential benefits and harms – usually a randomised trial and often with patients ‘blinded’ to what treatment they are receiving.

And only when these tests have been reviewed in detail by expert panels will they be approved for any kind of government reimbursement. It’s a high bar and it needs to be, otherwise public money may be wasted and/or people may be unnecessarily harmed.

Regulation of medical devices

How high is the ‘bar’ for surgery to clear before acceptance? Well, it depends. For a start, there are two different pathways: one for devices (things that are implanted in the body, like joint replacements, stents and heart valves) and one for procedures. Implantable devices are not required to have high quality (randomised trial) evidence comparing them to previously approved devices or placebo. In fact, they just need to show that they are “similar” (structurally) to existing (already approved) devices and that they are safe.

This ‘low bar’ for devices has led to problems like the worldwide recall of some hip replacement devices after being used in thousands of people. The mechanical properties and structural design of these hip replacement devices were very similar to already-approved devices and they passed the approval process based on that similarity. Unfortunately, however, the subtle differences in design in these new hip replacement devices were enough to cause catastrophic failure in a large number of cases – something that would have been easily detected if clinical evidence of actual effectiveness in real people had been required, like it is for drugs.

Some years ago, partly in response to such cases as described above, the government made “clinical evidence” for new devices a requirement for acceptance for clinical use, yet the type or standard of clinical evidence has never been made clear. Simply showing that the device has been implanted in some people without terrible early failures seems to be enough – nothing about comparative studies where the device is tested against a successful device.

Regulation of techniques and procedures

Separate to devices is the ‘bar’ that techniques and procedures are required to clear. Here, there is almost no bar if the procedures falls within an existing description. As an example, orthopaedic surgeons recently started doing hip replacements using a new technique: the anterior approach, which involves literally coming at (“approaching”) the hip from the front rather than the back or the side.

There was a bit of a learning curve involved, as there were more complications associated with using this new technique (for example, the thigh bone would break more often when trying to insert the hip). Eventually, things worked out and this new technique is commonly used and probably not any worse than other techniques. For a while however, it looked like a potential disaster, with no regulatory or ethical oversight involved, just individual surgeons trying a new technique.

In fact, the regulatory environment that does exist around new techniques is not only inadequate, it is actually counter-productive. For example, for a surgeon to invent and perform a new technique (perhaps yet another way to perform hip replacements), there is no regulatory oversight, either from the government or from institutional ethics committees: it is not necessary to get ethics committee approval to trial new procedures or techniques.

However, if the surgeon wanted to gather information on the effectiveness of a new technique by performing a comparative study against the old technique or contacting patients to accurately measure the results of surgery, that surgeon would not be permitted to do so without approval from an ethics committee. So it is OK to try new things without measuring the outcome or studying it scientifically, but if you want to find out if it works or is not harmful, you are faced with an onerous process of getting ethics approval to contact the patients and publish the findings. Many would argue the exact opposite, that ethical approval should be required if a surgeon did not measure and report the results of a new technique.

Changing the paradigm

This problem reflects our underlying tendency to assume that something is effective when it has not been tested: we end up with wasteful, ineffective and often harmful procedures and devices being approved and used. At best, we end up with procedures with unknown effectiveness.

There is no good reason to have such a low bar for the introduction of new devices and techniques. The reason we have such a low bar is tradition, which is almost never a good reason.

The reason for this low bar is that many (probably most) of the currently performed surgical procedures listed in the Medical Benefits Schedule (MBS) were “grandfathered” in when the scheme began in the 1980s. Many have never been subjected to rigorous testing against non-surgical alternatives or no treatment at all. The only time rigorous evidence (an appropriate bar) is required for a new surgical procedure or device is if it does not lie within descriptions currently listed in the MBS. In these cases, applications for listing new surgeries are frequently rejected for failing to have sufficient high-quality evidence.

The system needs overhauling, but the inertia inherent in the current systems is such that this may never occur. It may be a massive task to test (already approved) surgical procedures that lack good evidence for effectiveness, but that doesn’t mean we should never start. It wouldn’t be too hard to begin with a few procedures and build up the evidence over time.

For example, instead of funding spine fusions for back pain indefinitely, why not put the money into trials of effectiveness? This could potentially save billions of dollars and patient harms. Any resulting savings could be put into testing the next procedure on the list. This could be done with one simple decision from the government: to make the bar for procedures currently on the MBS (that were grandfathered in in the 1980s) the same as the bar for newprocedures to be listed on the MBS. Otherwise, it must justify having such a paradoxical system of approval.

Ian Harris is Professor of Orthopaedic Surgery at UNSW and the author of Surgery, The Ultimate Placebo

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This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare and Croakey.org.

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

Bookmark this link and follow #WiserHealthcare on Twitter.