‘Devastated and sad’ after 36 years of research — early detection of ovarian cancer doesn’t save lives

Posted on May 25, 2021 by particularkev

Ian Jacobs, UNSWMy colleagues’ and my efforts to develop a screening test for the early detection of ovarian cancer capable of saving lives arrived at a sad moment last week. The final trial results of the research I’ve focused on for 36 years, published in The Lancet, found early ovarian cancer detection doesn’t save lives.

The advances we have seen in science and technology over the past three decades have been nothing short of phenomenal. Each smartphone has more computational power than NASA had at its disposal during the moon landings. In medicine, researchers have sequenced the human genome, created life-saving treatment for HIV and rapidly developed vaccines for COVID-19.

There have been significant improvements in ovarian cancer treatment involving surgery and chemotherapy, but the sad and frustrating truth is of the four women diagnosed with ovarian cancer in Australia each day, three will eventually die from the disease.

The diagnosis of ovarian cancer is dependent on women reporting symptoms to their doctor. However, few develop symptoms until they have advanced stage cancer, by which time the outlook is poor. Of all women’s cancers, ovarian cancer has the lowest survival rate, with just 46% of patients in Australia surviving five years. For breast cancer, it’s now 91%.

Back in the 80s

I was motivated to improve the outcome for women with ovarian cancer by my experience as a junior doctor in London in 1985. I was training with a brilliant surgeon who undertook operations for many women with ovarian cancer. In spite of the exhaustive surgery and the chemotherapy that followed, we saw far too many women suffer and die from ovarian cancer.

That experience inspired me to initiate a program of research designed to find a screening test to detect this cancer early. Women with the earliest stage of ovarian cancer had survival rates of 70%, but less than 20% of women with ovarian cancer were diagnosed that early.

My hypothesis was that if we could detect more cancers at an early stage it would save lives.

We saw too many women suffer and die from ovarian cancer.
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Based on evidence from other cancers, there was reason to be hopeful and two potential tests were available – a blood test called CA 125 and the use of ultrasound scanning which was then widely used in obstetrics.

Over the next 15 years, working with colleagues in the United Kingdom and United States, I developed and refined the screening tests and had great hope for what we called “multimodal screening”. This involved a “risk of ovarian cancer algorithm” for interpreting the change in blood levels of CA 125 over time to identify women who had a rising pattern, indicating an elevated risk of ovarian cancer. Women with an elevated risk could then have a secondary test involving ultrasound scanning.

During those 15 years, we published convincing evidence in studies involving over 50,000 women that this approach to screening was safe, acceptable to women, could detect over 85% of the cancers early and would probably be cost effective if sufficient lives were saved.

Promising early results

Before advocating screening of the general population, a massive trial would be needed to determine whether the screening would actually save lives.

The trial needed to involve screening and follow up of approximately 200,000 women for around 20 years. This would eventually include 2,000 women with ovarian cancer – enough to determine whether or not screening saved lives.

The trial involved great numbers of participants.
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Work got underway in the United Kingdom in 2000 and optimism grew as initial results confirmed the ability of multimodal screening to detect cancer early in over 85% of cases.

By 2015, the preliminary mortality data were available and were tantalising. The curves hinted at a 20% or more reduction in deaths from ovarian cancer, but the findings did not quite reach statistical significance. So another five years of painstaking follow up was needed.

Disappointing final results

The final results of the UK Collaborative Trial of Ovarian Cancer Screening showed the multimodal screening approach could detect cancers early and increase the number of early-stage ovarian cancers by almost 50%.

But to our surprise and despair, that did not reduce the number of deaths from ovarian cancer. All it seemed to do was to bring forward the time of diagnosis of the cancers in these women, without improving their survival.

Woman has blood taken for a blood test. — Under the multimodal screening program, women were first given a blood test for levels of CA 125.
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This is deeply disappointing. Disappointing of course for those who like myself have dedicated much of their professional lives to this effort, but much more importantly for the women across the world who we had hoped would have access to an effective screening test able to save lives.

The hope had been to deploy ovarian cancer screening for women in the general population alongside breast and cervical cancer screening, but that will not happen – for a while at least.

Why didn’t early detection save lives?

To answer that, we need to further analyse samples and data from the trial. Our suspicion is that the women whose cancers were detected early by screening had more aggressive cancers than those (the 10%) whose cancers were detected early without screening, on the basis of symptoms.

So even with early detection, their cancers progressed relentlessly despite them receiving the best available surgery and chemotherapy.

If that is the case, we are likely to require screening tests which can detect ovarian cancer even earlier than our algorithm, which we estimate picks up ovarian cancer 18 to 24 months early. Saving lives may require a test capable of picking up the cancers five or more years early.

Fortunately, there are exciting avenues of research involving advances in protein and DNA technologies which researchers in Australia and around the world are exploring. So there is hope.

But realistically, given the five-plus years needed to develop better screening tests and the ten to 15-plus years needed to have enough cases to conduct another large randomised trial, the solution is likely to be more than 20 years away.

Still, we’ve learnt a lot

This massive commitment of expertise, time, energy and funding has most definitely not been wasted. Much has been achieved along the way in this 36-year journey in developing ways to assess risk, diagnose cancer and prevent ovarian cancer which are now used in clinical practice.

New generations of researchers have been trained. The data and the blood bank collected is available to all researchers seeking new and better screening tests and is a unique resource. And the ability to detect ovarian cancer early may be invaluable in assessing new treatments.

I feel privileged to have led this effort and will always be grateful to the collaborators, researchers, health professionals, funding agencies and above all the 200,000 women who took part in the trial.

I feel a deep sadness that lives will not yet be saved by ovarian cancer screening, but I’m confident the next generation of researchers will build on our work and find approaches to screening and treatment of ovarian cancer which dramatically reduce the loss and suffering caused by this insidious disease.

Ian Jacobs, President and Vice-Chancellor, UNSW

This article is republished from The Conversation under a Creative Commons license. Read the original article.

A disease that breeds disease: why is type 2 diabetes linked to increased risk of cancer and dementia?

Posted on May 29, 2020 by particularkev

Rachel Climie, Baker Heart and Diabetes Institute and Jonathan Shaw, Baker Heart and Diabetes Institute

In Australia, more than 1.1 million people currently have type 2 diabetes.

A host of potential complications associated with the disease mean a 45-year-old diagnosed with type 2 diabetes will live on average six years less than someone without type 2 diabetes.

This week we published a report bringing together the latest evidence on the health consequences of type 2 diabetes.

Aside from demonstrating the complications we know well – like the link between diabetes and heart disease risk – our report highlights some newer evidence that suggests type 2 diabetes is associated with an increased risk of cancer and dementia.

Common complications of type 2 diabetes

Type 2 diabetes, which typically develops after the age of 40, is usually due to a combination of the pancreas failing to produce enough of the hormone insulin, and the cells in the body failing to adequately respond to insulin.

Since insulin is the key regulator of blood glucose (sugar), this causes a rise in the blood sugar levels.

Risk factors for developing type 2 diabetes include being overweight, being physically inactive, having a poor diet, high blood pressure and family history of type 2 diabetes.

Being overweight is a risk factor for type 2 diabetes – but not all people with type 2 diabetes are overweight.
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People with type 2 diabetes are about twice as likely to develop heart disease than people without type 2 diabetes.

While heart attacks, due to blockages in the coronary arteries, are perhaps the better recognised form of heart disease, heart failure, where the heart muscle is unable to pump enough blood around the body, is becoming more common, especially in people with type 2 diabetes.

This is due to a number of factors, including better treatment and prevention of heart attacks, which has allowed more people to survive long enough to develop heart failure.

People with type 2 diabetes are up to eight times more likely to develop heart failure compared to those without diabetes.

Meanwhile, diabetes is the most common cause of kidney failure and vision loss in working age adults, and accounts for more than 50% of foot and leg amputations.

But beyond these common and familiar complications of diabetes, there’s mounting evidence to suggest type 2 diabetes increases the risk of other diseases.

Emerging complications of type 2 diabetes

People with type 2 diabetes are approximately two times more likely to develop pancreatic, endometrial and liver cancer, have a 30% higher chance of getting bowel cancer and a 20% increased risk of breast cancer.

Increased cancer risk is of particular concern for the growing number of people under 40 living with type 2 diabetes. In Australia, this group saw a significant increase in deaths from cancer between 2000 and 2011.

Dementia, too, is a recently recognised complication of type 2 diabetes. A meta-analysis involving data from two million people showed people with type 2 diabetes have a 60% greater risk of developing dementia compared to those without diabetes.

Why the increased risk?

It’s important to acknowledge the studies we looked at are observational and can’t tell us diabetes necessarily caused these conditions. But they do suggest having diabetes is associated with an increased risk.

The two leading theories for why cancer risk is increased in people with type 2 diabetes relate to glucose and insulin.

Many types of cancer cells use glucose as a key fuel, so the more glucose in the blood, potentially, the more rapidly cancer will grow.

Alternatively, insulin can promote the growth of cells. And since in the early stages of type 2 diabetes insulin levels are elevated, this might also promote the development of cancer.

It’s especially important people with diabetes take up cancer screening programs.
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There are several possible explanations for the link between diabetes and dementia. First, strokes are more common in people with type 2 diabetes, and both major and repeated mini-strokes can lead to dementia.

Second, diabetes affects the structure and function of the smallest blood vessels throughout the body (the capillaries), including in the brain. This may impair the delivery of nutrients to a person’s brain cells.

Third, high glucose levels and other metabolic disturbances associated with diabetes may, over time, directly affect the way certain types of brain cells function.

Room for improvement

Despite well-established recommendations for the management of type 2 diabetes, such as guidelines for medication use, healthy diet and regular physical activity, there remains a significant gap between the evidence and what happens in practice.

A study from the US showed only one in four patients with type 2 diabetes met all the recommended targets for healthy levels of glucose, cholesterol and blood pressure.

Australian data has shown having diabetes is associated with 14% increased likelihood of discontinuing cholesterol medication after one year.

In our report, we showed increasing the use of a range of effective medications would prevent many hundreds of people with diabetes developing heart disease, strokes and kidney failure each year.

With the burden of diabetes complications in our community casting such a large shadow in terms of death rates, disability and impact on the health system, we need greater education and support for people with living diabetes, as well as health professionals treating the condition.

For people with type 2 diabetes, close monitoring for other diseases such as cancer through screening programs is particularly important.

And alongside managing their blood sugar levels, it’s essential Australians with type 2 diabetes are supported to keep risk factors for complications, such as blood pressure and cholesterol, at healthy levels.

A healthy diet and regular physical activity is a good place to start.

Rachel Climie, Exercise Physiologist and Research Fellow, Baker Heart and Diabetes Institute and Jonathan Shaw, Deputy Director, Baker Heart and Diabetes Institute

This article is republished from The Conversation under a Creative Commons license. Read the original article.

29,000 cancers overdiagnosed in Australia in a single year

Posted on February 7, 2020 by particularkev

Men are 17% more likely to be diagnosed with cancer than they were 30 years ago.
fizkes/Shutterstock

Alexandra Barratt, University of Sydney; Katy Bell, University of Sydney; Mark Jones, Bond University; Paul Glasziou, Bond University, and Thanya Pathirana, Griffith University

Almost one in four cancers detected in men were overdiagnosed in 2012, according to our new research, published today in the Medical Journal of Australia.

In the same year, we found that approximately one in five cancers in women were overdiagnosed.

Overdiagnosis is when a person is diagnosed with a “harmless” cancer that either never grows or grows very slowly. These cancers are sometimes called low or ultra-low-risk cancers and wouldn’t have spread or caused any problems even if left untreated.

This level of overdiagnosis means Australian men are 17% more likely to be diagnosed with cancer in their lifetime than they were 30 years ago, while women are 10% more likely.

Cancer overdiagnosis can result in people having unnecessary treatments, such as surgery, radiotherapy and hormone therapy. Being diagnosed with cancer and having cancer treatments can cause physical, psychological and financial harms.

How many cancers were overdiagnosed?

In 2012, 77,000 cancers were diagnosed among Australian men. We estimated that 24% of these (or 18,000 in total) were overdiagnosed, including:

8,600 prostate cancers
8,300 melanomas
860 kidney cancers
500 thyroid cancers.

Some 55,000 cancers were diagnosed in women; 18% of them (11,000) were overdiagnosed. This includes:

4,000 breast cancers
5,600 melanomas
850 thyroid cancers
660 kidney cancers.

These calculations are based on changes since 1982 in the lifetime risk of cancers, after adjusting for other causes of death and changing risk factors.

Mammograms sometimes detect cancers that wouldn’t grow, spread, or cause the woman any harm.
GagliardiPhotography/Shutterstock

Because they are more common, prostate and breast cancer and melanoma accounted for the greatest number of overdiagnosed cancers, even though larger percentages of thyroid cancers were overdiagnosed.

In women, for example, 73% of thyroid cancers were overdiagnosed, while 22% of breast cancers were overdiagnosed.

The harms to patients come from the unnecessary surgery, and other treatments, as well as the anxiety and expenses.

Three in four patients with thyroid “cancers” that are overdiagnosed, for example, will almost all have their thyroid completely removed, risk complications, and have to take replacement thyroid medication for the rest of their life.

In addition, there are substantial costs to the health system, and delays in necessary surgery.

Some “good news” is that overdiagnosis appears to be largely confined to the five main cancers mentioned above.

What causes cancer overdiagnosis?

The cause of overdiagnosis differs for each cancer.

For prostate cancer, the cause is the quest for early detection of prostate cancer using the prostate specific antigen (PSA) blood test. A downside of PSA testing is the risk of detecting large numbers of low-risk prostate cancers which may be overtreated.

For breast cancer, the cause is also early detection, through mammography screening which can detect low-risk cancers.

Likewise, detection of low-risk melanoma accounted for most of the melanoma overdiagnosis we observed. Early detection activities again are the likely cause, with many times more skin biopsies being done today than 30 years ago.

Overdiagnosis of kidney and thyroid cancer is due largely to “incidentalomas” – abnormalities found incidentally on imaging done for other reasons – or through over-investigation of mild thyroid problems.

What can we do about it?

Some level of overdiagnosis is unavoidable in a modern health-care system committed to screening to reduce the disease and death burden from cancer.

We want to maximise the timely detection of high-risk cancers that allows the best chance of cure through early surgery and other treatments.

But this is still possible while taking measures to prevent overdiagnosis and overtreatment of low-risk cancers that are better left undetected.

Take South Korea, for example. Following the introduction of a screening program for thyroid cancer, the country saw a 15-fold increase in small, low-risk thyroid cancers. Then it cut back on early detection. This led to a major drop in thyroid cancer rates without any change in death rates.

Rates of PSA testing are comparatively high in Australia.
ariadna de raadt/Shutterstock

Rates of PSA testing in Australia are among the highest in the world. Countries where there is less PSA testing, such as the United Kingdom, detect less low-risk prostate cancer, and therefore have less overtreatment.

Rather than simply accepting PSA testing, a wiser strategy is to make an informed decision whether to go ahead with it or not. Tools to help you choose are available here and here.

A decision aid is also available for Australian women to consider whether to go ahead with mammogram screening or not.

Trials to wind back treatment of low-risk prostate cancer have resulted in clinical practice guidelines which recommend men with low-risk prostate cancer be offered active surveillance as an alternative to immediate surgery or radiation therapy.

Trials to evaluate less treatment for low-risk breast cancer are now under way and should help wind back breast cancer overtreatment one day.

New screening tests that identify clinically important cancers, while leaving slow- and never-growing cancers undetected, are the holy grail. But they could be some time coming.

In the meantime, health services need to be vigilant in monitoring new areas of overdiagnosis, particularly when investing in new technologies with potential to further increase overdiagnosis.

Alexandra Barratt, Professor of Public Health, University of Sydney; Katy Bell, Associate in Clinical Epidemiology in the School of Public Health, University of Sydney; Mark Jones, Associate Professor, Biostatistician, Institute for Evidence-Based Healthcare, Bond University; Paul Glasziou, Professor of Medicine, Bond University, and Thanya Pathirana, Senior Lecturer, School of Medicine, Griffith University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Does eating dairy foods increase your risk of prostate cancer?

Posted on November 2, 2019 by particularkev

If you’re a male who enjoys dairy, there’s no reason to stop having it.
From shutterstock.com

Rosemary Stanton, UNSW

Research Checks interrogate newly published studies and how they’re reported in the media. The analysis is undertaken by one or more academics not involved with the study, and reviewed by another, to make sure it’s accurate.

Recent headlines have warned a diet high in dairy foods may increase men’s risk of prostate cancer.

The news is based on a recent review published in the Journal of the American Osteopathic Association which claimed to find eating high quantities of plant-based foods may be associated with a decreased risk of prostate cancer, while eating high quantities of dairy products may be associated with an increased risk.

But if you’re a man, before you forego the enjoyment and known nutritional benefits of milk, cheese and yoghurt, let’s take a closer look at the findings.

What the study did

This study was a review, which means the researchers collated the findings of a number of existing studies to reach their conclusions.

They looked at 47 studies which they claim constitute a comprehensive review of all available data from 2006-2017. These studies examined prostate cancer risk and its association with a wide variety of foods including vegetables, fruits, legumes, grains, meat (red, white and processed), milk, cheese, butter, yoghurt, total diary, calcium (in foods and supplements), eggs, fish and fats.

Some studies followed groups of men initially free of prostate cancer over time to see if they developed the disease (these are called cohort studies). Others compared health habits of men with and without prostate cancer (called case-control studies). Some studies recorded the incidence of prostate cancer in the group while others concentrated on the progression of the cancer.

For every potential risk factor, the reviewers marked studies as showing no effect, or an increased or decreased risk of prostate cancer. The results varied significantly for all the foods examined.

For cohort studies (considered more reliable than case-control studies), three studies for vegan diets and one for legumes recorded decreased risk of prostate cancer. For vegetarian diets and vegetables, some reported decreased risk and some recorded no effect. Fruits, grains, white meat and fish appeared to have no effect either way.

An increased risk was reported for eggs and processed meats (one study each), red meat (one out of six studies), fats (two out of five), total dairy (seven out of 14), milk (six out of 15), cheese (one out of six), butter (one out of three), calcium (three out of four from diet and two out of three from supplements) and fats (two out of five).

Notably, some very large cohort studies included in the review showed no association for milk or other dairy products. And most case-control studies, though admittedly less reliable, showed no association.

The authors also omitted other studies published within the review period which showed no significant association between dairy and prostate cancer.

A person’s weight likely has more influence on their risk of developing prostate cancer than whether or not they eat dairy.
From shutterstock.com

So the inconsistency in results across the studies reviewed – including large cohort studies – amount to very limited evidence dairy products are linked to prostate cancer.

Could it be vitamin D?

In earlier research, a link between milk and prostate cancer has been attributed to a high calcium intake, possibly changing the production of a particular form of vitamin D within the body.

Vitamin D is an important regulator of cell growth and proliferation, so scientists believed it may lead to prostate cancer cells growing unchecked. But the evidence on this is limited, and the review adds little to this hypothesis.

Perhaps the review’s most surprising omission is mention of the World Cancer Research Fund (WCRF) Continuous Update Project report on prostate cancer. This rigorous global analysis of the scientific literature identified much stronger risk factors that should be considered as possible confounding factors.

For example, the evidence is rated as “strong” that being overweight or obese, and being tall (separate to weight), are associated with increased risk of prostate cancer. The exact reasons for this are not fully understood but could be especially significant in Australia where 74% of men are overweight or obese.

A new Australian study found a higher body mass index was a risk factor for aggressive prostate cancer.

For dairy products and diets high in calcium, according to the WCRF, the evidence remains “limited”.

It’s about the whole diet

It’s not wise to judge any diet by a single food group or nutrient. A healthy diet overall should be the goal.

That being said, milk, cheese and yoghurt are included in Australia’s Dietary Guidelines because of evidence linking them with a lower risk of heart disease, type 2 diabetes, bowel cancer and excess weight. These dairy products are also sources of protein, calcium, iodine, several of the B complex vitamins, and zinc.

Evidence about dairy products and prostate cancer remains uncertain. So before fussing about whether to skip milk, cheese and yoghurt, men who wish to reduce their risk of prostate cancer would be better advised to lose any excess weight. – Rosemary Stanton

Blind peer review

I agree with the author of this Research Check who highlights there is a high degree of variability in the results of the studies examined in this review.

While the authors searched three journal databases, most comprehensive reviews search up to eight databases. Further, the authors did not undertake any assessment of the methodological quality of the studies they looked at. So the results should be interpreted with caution.

Although the authors concluded higher amounts of plant foods may be protective against prostate cancer, the figure presented within the paper indicates more studies reported no effect compared to a decreased risk, so how they came to that conclusion in unclear. For total dairy they present a figure showing there were as many studies suggesting no effect or lower risk as there were showing higher risk.

Importantly, they did not conduct any meta-analyses, where data are mathematically pooled to generate and overall effect across all studies.

As the reviewer points out, many other important sources of high quality data have not been included and there are a number of recent higher quality systematic reviews that could be consulted on this topic. – Clare Collins

Rosemary Stanton, Visiting Fellow, School of Medical Sciences, UNSW

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Do new cancer drugs work? Too often we don’t really know (and neither does your doctor)

Posted on September 28, 2019 by particularkev

The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn’t necessarily equate to improved survival rates.
From shutterstock.com

Barbara Mintzes, University of Sydney and Agnes Vitry, University of South Australia

It’s hard to find anyone who hasn’t been touched by cancer. People who haven’t had cancer themselves will likely have a close friend or family member who has been diagnosed with the disease.

If the cancer has already spread, the diagnosis may feel like a death sentence. News that a new drug is available can be a big relief.

But imagine a cancer patient asks their doctor: “Can this drug help me stay alive longer?” And in all honesty the doctor answers: “I don’t know. There’s one study that says the drug works, but it didn’t show whether patients lived longer, or even if they felt any better.”

This might sound like an unlikely scenario, but it’s precisely what a team of UK researchers found to be the case when it comes to many new cancer drugs.

A look at the research

A study published last week in the British Medical Journal reviewed 39 clinical trials supporting approval of all new cancer drugs in Europe from 2014 to 2016.

The researchers found more than half of these trials had serious flaws likely to exaggerate treatment benefits. Only one-quarter measured survival as a key outcome, and fewer than half reported on patients’ quality of life.

Of 32 new cancer drugs examined in the study, only nine had at least one study without seriously flawed methods.

The researchers evaluated methods in two ways. First, they used a standard “risk of bias” scale that measures shortcomings shown to lead to biased results, such as if doctors knew which drug patients were taking, or if too many people dropped out of the trial early.

Second, they looked at whether the European Medicines Agency (EMA) had identified serious flaws, such as a study being stopped early, or if the drug was compared to substandard treatment. The EMA identified serious flaws in trials for ten of the 32 drugs. These flaws were rarely mentioned in the trials’ published reports.

From clinical trials to treatment – faster isn’t always better

Before a medicine is approved for marketing, the manufacturer must carry out studies to show it’s effective. Regulators such as the EMA, the US Food and Drug Administration (FDA) or Australia’s Therapeutic Goods Administration (TGA) then judge whether to allow it to be marketed to doctors.

National regulators mainly examine the same clinical trials, so the findings from this research are relevant internationally, including in Australia.

There’s strong public pressure on regulators to approve new cancer drugs more quickly, based on less evidence, especially for poorly treated cancers. The aim is to get treatments to patients more quickly by allowing medicines to be marketed at an earlier stage. The downside of faster approval, however, is more uncertainty about treatment effects.

One of the arguments for earlier approvals is the required studies can be carried out later on, and sick patients can be given an increased chance of survival before it’s too late. However, a US study concluded that post-approval studies found a survival advantage for only 19 of 93 new cancer drugs approved from 1992 to 2017.

If the evidence for a new cancer drug is flawed, this leaves patients vulnerable to false hope.
From shutterstock.com

So how is effectiveness measured currently?

Approval of new cancer drugs is often based on short-term health outcomes, referred to as “surrogate outcomes”, such as shrinking or slower growth of tumours. The hope is these surrogate outcomes predict longer-term benefits. For many cancers, however, they have been found to do a poor job of predicting improved survival.

A study of cancer trials for more than 100 medicines found on average, clinical trials that measure whether patients stay alive for longer take an extra year to complete, compared to trials based on the most commonly used surrogate outcome, called “progression free survival”. This measure describes the amount of time a person lives with a cancer without tumours getting larger or spreading further. It’s often poorly correlated with overall survival.

A year may seem like a long wait for someone with a grim diagnosis. But there are policies to help patients access experimental treatments, such as participating in clinical trials or compassionate access programmes. If that year means certainty about survival benefits, it’s worth waiting for.

Approving drugs without enough evidence can cause harm

In an editorial accompanying this study, we argue that exaggeration and uncertainty about treatment benefits cause direct harm to patients, if they risk severe or life-threatening harm without likely benefit, or if they forgo more effective and safer treatments.

For example, the drug panobinostat, which is used for multiple myeloma patients who have not responded to other treatments, has not been shown to help patients live longer, and can lead to serious infections and bleeding.

Inaccurate information can also encourage false hope and create a distraction from needed palliative care.

And importantly, the ideal of shared informed decision-making based on patients’ values and preferences falls apart if neither the doctor nor the patient has accurate evidence to inform decisions.

In countries with public health insurance, such as Australia’s Pharmaceutical Benefits Scheme (PBS), patients’ access to new cancer drugs depends not just on market approval but also on payment decisions. The PBS often refuses the pay for new cancer drugs because of uncertain clinical evidence. In the cases of the drugs in this research, some are available on the PBS, while others are not.

New cancer drugs are often very expensive. On average in the US, a course of treatment with a new cancer drug costs more than US$100,000 (A$148,000).

Cancer patients need treatments that help them to live longer, or at the very least to have a better quality of life during the time that they have left. In this light, we need stronger evidence standards, to be sure there are real health benefits when new cancer drugs are approved for use.

The article has been updated to reflect Agnes Vitry’s current role at the University of South Australia.

Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of Sydney and Agnes Vitry, Senior lecturer, University of South Australia

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Here’s what you can eat and avoid to reduce your risk of bowel cancer

Posted on September 14, 2019 by particularkev

It’s not certain why, but fibre has protective effects against bowel cancer.
http://www.shutterstock.com

Suzanne Mahady, Monash University

Australia has one of the highest rates of bowel cancer in the world. In 2017, bowel cancer was the second most common cancer in Australia and rates are increasing in people under 50.

Up to 35% of cancers worldwide might be caused by lifestyle factors such as diet and smoking. So how can we go about reducing our risk of bowel cancer?

What to eat

Based on current evidence, a high fibre diet is important to reduce bowel cancer risk. Fibre can be divided into 2 types: insoluble fibre, which creates a bulky stool that can be easily passed along the bowel; and soluble fibre, which draws in water to keep the stool soft.

Fibre from cereal and wholegrains is an ideal fibre source. Australian guidelines suggest aiming for 30g of fibre per day for adults, but fewer than 20% of Australian adults meet that target.

Wheat bran is one of the richest sources of fibre, and in an Australian trial in people at high risk of bowel cancer, 25g of wheat bran reduced precancerous growths. Wheat bran can be added to cooking, smoothies and your usual cereal.

It’s not clear how fibre may reduce bowel cancer risk but possible mechanisms include reducing the time it takes food to pass through the gut (and therefore exposure to potential carcinogens), or through a beneficial effect on gut bacteria.

Once bowel cancer is diagnosed, a high fibre diet has also been associated with improved survival.

Dairy is ‘probably’ protective against bowel cancer.
from http://www.shutterstock.com

Milk and dairy products are also thought to reduce bowel cancer risk. The evidence for milk is graded as “probably protective” in current Australian bowel cancer guidelines, with the benefit increasing with higher amounts.

Oily fish may also have some protective elements. In people with hereditary conditions that make them prone to developing lots of precancerous growths (polyps) in the bowel, a trial where one group received a daily supplement of an omega 3 polyunsaturated fatty acid (found in fish oil) and one group received a placebo, found that this supplement was associated with reduced polyp growth. Whether this is also true for people at average risk of bowel cancer, which is most of the population, is unknown.

And while only an observational study (meaning it only shows a correlation, and not that one caused the other), a study of bowel cancer patients showed improved survival was associated with daily consumption of coffee.

What to avoid

It’s best to avoid large quantities of meat. International cancer authorities affirm there is convincing evidence for a relationship between high meat intake and bowel cancer. This includes red meat, derived from mammalian muscle such as beef, veal, lamb, pork and goat, and processed meat such as ham, bacon and sausages.

Processed meats have undergone a preservation technique such as smoking, salting or the addition of chemical preservatives which are associated with the production of compounds that may be carcinogenic.

Evidence also suggests a “dose-response” relationship, with cancer risk rising with increasing meat intake, particularly processed meats. Current Australian guidelines suggest minimising intake of processed meats as much as possible, and eating only moderate amounts of red meat (up to 100g per day).

What else can I do to reduce the risk of bowel cancer?

The key to reducing cancer risk is leading an overall healthy lifestyle. Adequate physical activity and avoiding excess fat around the tummy area is important. Other unhealthy lifestyle behaviours such as eating lots of processed foods have been associated with increased cancer risk.

And for Australians over 50, participating in the National Bowel Cancer Screening program is one of the most effective, and evidence-based ways, to reduce your risk.

Suzanne Mahady, Gastroenterologist & Clinical Epidemiologist, Senior Lecturer, Monash University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Shorten promises $2.3 billion package to relieve costs for cancer patients

Posted on April 25, 2019 by particularkev

Michelle Grattan, University of Canberra

Bill Shorten has promised his government would introduce a A$2.3 billion four year package to slash cancer patients’ out-of-pocket costs, and has committed $1 billion to give extra tax relief for low income earners, above what they would get from Tuesday’s budget.

In his budget reply on Thursday night, the opposition leader pitched to voters on a Labor strength – health – declaring his cancer care plan would be the “most important investment in Medicare since Bob Hawke created it”.

Shorten rejected the government’s second and third tranches of tax cuts, due to start in 2022-23 and 2024-25 and worth about $143 billion of the $158 billion ten year package. The last stage was a “radical, right-wing, flat tax experiment”, far off in time and skewed disproportionately to a relative few, he said.

Stressing Labor’s economic responsibility, Shorten recommitted to delivering “stronger surpluses, paying down debt faster” than the government.

“What we need is a fighting fund for the country, a strong surplus to protect us from international shocks”, he said.

He attacked the government – which has a $7.1 billion surplus in its budget for next financial year – for “shortchanging the NDIS [National Disability Insurance Scheme] by $1.6 billion, to prop up a flimsy surplus forecast”.

Shorten – who in his speech referred to his late mother Ann’s battle with breast cancer – said the cancer care plan would provide for millions of free scans and consultations, and cheaper medicines.

Cancer “is frightening, it’s isolating, it’s exhausting”. And all too often, it was impoverishing, he said.

“For so many people, cancer makes you sick and then paying for the treatment makes you poor. And that’s a fact that I think a lot of Australians would be surprised to learn.

“Because if you haven’t been through it yourself, you might not realise that all those vital scans and tests and consultations with specialists aren’t fully covered by Medicare. Instead, they cost hundreds of dollars, adding up to thousands, out of your own pocket,” he said.

One in four women with breast cancer paid more than $10,000 for two years of scans and tests, he said. Some men with prostate cancer were paying more than $18,000. Most people with skin cancer – and Australia has the highest rates of this cancer in the world – paid more than $5000 for the first two years of treatment.

Each year 300,000 people who needed radiology did not get it, because they couldn’t afford it.

People needing treatment for cancer were often not well enough to work, so they were already under massive financial strain, Shorten said. Those living in regional areas had the extra costs of travel and accommodation.

A Labor government would:

invest $600 million towards eliminating all out-of-pocket costs for diagnostic imaging, with up to six million free cancer scans funded through Medicare – reducing out-of-pocket costs from hundreds of dollars to zero. This would include MRIs too. At present only half the MRI machines were covered by Medicare, and regional patients often had to drive for hours or pay thousands of dollars. “If we win the election, not only will we provide more MRI machines to communities where they are needed most, but Labor will guarantee that every single MRI machine in Australia that meets a national quality standard is covered by Medicare for cancer scans.”
invest $433 million to fund three million free consultations with oncologists and surgeons. Over four years this would mean an extra three million appointments were bulk billed, reducing costs of hundreds of dollars to nothing
guarantee that every drug recommended by independent experts would be listed on the Pharmaceutical Benefits Scheme.

On tax, Shorten said people earning between $48,000 and $126,000, no matter who they voted for in May, would get the same tax refund.

But the Liberal plan did not do enough for the 2.9 million people who earned less than $40,000 – about 57% of whom were women.

In Labor’s first budget Labor would provide a bigger tax refund for low earners than the Liberals proposed.

“6.4 million working people will pay the same amount of income tax under Labor as the Liberals – and another 3.6 million will pay less tax under Labor,” he said. “All told, an extra billion dollars, for low income earners”.

Under further details provided by Labor, it said workers earning up to $37,000 a year would receive a tax cut of up to $350. For workers earning between $37,000 and $48,000 the value of the tax offset would increase up to the maximum tax offset of $1,080.

A worker on $35,000 would get a tax cut of $255 a year under the Liberals, compared to $350 under Labor. A worker on $40,000 would receive a cut of $480 under the Liberals compared to $549 under Labor.

On TAFE Shorten promised to double the size of Labor’s rebuilding TAFE program – up to $200 million – to renovate campuses.

Labor is committed to paying the upfront fees for 100,000 TAFE places to get more Australians in high priority courses. “I am proud to announce that 20,000 of these places will be allocated to a new generation of aged care workers and paid carers for the NDIS,” Shorten said.

Finance minister Mathias Cormann said Shorten had put forward an agenda for $200 billion in higher taxes that would weaken the economy and bring higher unemployment.

Michelle Grattan, Professorial Fellow, University of Canberra

This article is republished from The Conversation under a Creative Commons license. Read the original article.

As Mediscare 2.0 takes centre stage, here’s what you need to know about hospital ‘cuts’ and cancer funding

Posted on April 16, 2019 by particularkev

Stephen Duckett, Grattan Institute

Health is proving a bone of contention in the 2019 election campaign. Labor has positioned health as a key point of difference, and the Coalition is arguing that Labor’s promises are untrue in one case and underfunded in another.

This cheat sheet will help you sort fact from fiction in two key health policy areas: public hospital funding and cancer care.

Public hospitals

In his budget reply, Opposition Leader Bill Shorten promised that Labor would restore every dollar the government had “cut” from public hospital funding.

The government counter-claimed that hospital funding has increased. So who is right?

The short answer is both.

In 2011, the then Labor government negotiated a funding agreement with the states for the Commonwealth to share 45% of the growth in the cost of public hospital care, funded at the “national efficient price”. This price is based on the average cost of the procedure, test or treatment.

The funding share was to increase to 50% of growth from July 1, 2017.

At the 2013 election, the then Liberal opposition agreed to match that promise and, indeed, claimed they were the only ones who could be trusted to keep the promise:

A Coalition government will support the transition to the Commonwealth providing 50% growth funding of the efficient price are hospital services as proposed. But only the Coalition has the economic record to be able to deliver.

However, in the 2014 budget the Coalition scrapped its promise. The 2014 budget papers list the savings that were made by the decision. It was a clear and documented cut that the Coalition was proud to claim at the time.

The green line represents the Gillard hospital funding agreement; the blue line is the revised projection from the 2014 budget.
Budget 2014-15

Since then, the Turnbull government has backtracked on the 2014 cuts to health but only to restore sharing to 45% of the costs of growth.

Labor has estimated the impact of the gap between 45% and 50% on every public hospital in the country, and spruiks the difference at every opportunity.

Hospital costs increase faster than inflation because of growth and ageing population, the introduction of new technologies, and new approaches to treatment.

As a result, the Commonwealth’s existing 45% sharing policy drives increased spending, and so Commonwealth spending is now at record levels, albeit not at the even higher levels that Labor had promised.

Labor’s promise is, appropriately, phrased as an additional quantum of money to the states, sufficient to restore the 50% share in the cost of growth.

The public hospital funding gap comes down to how much of the growth in hospital funding each party has committed to.
Shutterstock

The details of how this funding should be operationalised to the states should be left to detailed negotiations after the election as it is not good practice for all the details of your negotiating position to be aired in the heat of a campaign.

So Labor is right to say hospital funding is lower than it would have been if the 50% growth share commitment had been maintained. But the Coalition is right to say the Commonwealth is spending more on hospital care than when it came to office.

Cancer care

The second major element of the Labor campaign was a high-profile A$2.3 billion package to address high out-of-pocket costs for Australians with cancer. The package has three key components:

additional public hospital outpatient funding to reduce waiting times
a new bulk-billing item for consultations
more funding for MRI machines for cancer diagnosis.

Labor did not promise to eliminate out-of-pocket costs for cancer, not even for consultations. It claimed bulk-billing would increase from 40% to 80% of consultations.

This promise has led to another showdown between Labor and the Coalition. Health Minister Greg Hunt claims to have found a A$6 billion black hole in Labor’s cancer policy.

The Coalition has produced a list of 421 Medicare items used for cancer treatment – including treatment in private hospitals – and noted Labor has not allocated funds to cover the fees specialists charge for these items.

But Labor rightly claims the 421-item list is not what it promised. Labor’s promise was about increasing the rate of bulk-billing for consultations and is based on a new item which is only available if the specialist bulk-bills.

Expect more claims and counter-claims in the weeks ahead.

Stephen Duckett, Director, Health Program, Grattan Institute

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Cutting cancer costs is a worthy policy, but we need to try to prevent it too

Posted on April 9, 2019 by particularkev

Terry Slevin, Australian National University and Simone Pettigrew, Curtin University

Removing the financial worries from Australians diagnosed with cancer is bound to be a popular move.

The Opposition’s A$2.3 billion cancer care plan – announced in Bill Shorten’s budget reply speech on Thursday night – aims to ensure cancer treatment costs for scans, specialists and drugs are bulk billed or subsidised under the Pharmaceutical Benefits Scheme (PBS). It would be a hard heart indeed that did not welcome such a move.

Maybe even better than avoiding the out-of-pocket costs of treatment is preventing future cases of cancer. Around one-third of all cancers are preventable by not smoking, staying at a healthy weight, eating healthy food, being physically active, minimising alcohol consumption, and avoiding excessive sun exposure.

But apart from a small commitment to tobacco control in the 2019 budget, neither the government or opposition has made even the vaguest commitment to, or investment in, cancer prevention.

So far we have heard virtually nothing from either party on efforts to tackle obesity, promote healthy eating, encourage more physical activity, reduce alcohol consumption, promote sun protection, or boost efforts to increase participation in cancer screening and vaccination programs.

The government currently spends around A$2 billion a year on “public health”, which includes monitoring, regulation, as well as prevention and vaccination. This amounts to less than 2% of the nation’s total health expenditure of A$170 billion. That is about half of what we spend on patient transport.

A boost to 5% – or closer to A$8.5 billion – could make enormous strides in better prevention programs, driven by high-quality research.

Poor track record

When it comes to investment in disease prevention, the story is not strong for the Coalition.

The Rudd Labor government established the Australian National Preventive Health Agency (ANPHA) in 2009, with funding of around A$60 million a year. The agency ran national programs focusing on tobacco, alcohol, healthy eating and reducing alcohol consumption.

But the new Abbott government axed the agency in 2014, after drafting legislation to expunge it from the books.

From 2008 to 2014, the National Partnership Agreement on Preventive Health (NPAPH) funded programs in Australia tackling unhealthy eating, physical inactivity, drinking too much, and smoking, via a funding pool of A$872 million.

Programs such as Live Lighter and Foodcents, for example, provided evidenced-based and practical help for people to live healthy lives. Other programs improved the availability of nutritious foods, and ensured walking and cycling were safe and viable components of transport planning.

In 2012, the then Labor government committed to the continuation of the NPAPH to 2018, but it was axed by the Abbott government in the 2014 federal budget.

Prevention programs aim to make it easier for people to make healthy choices, such as being physically active and eating a nutritious diet.
Annie Spratt

This took hundreds of millions of dollars otherwise committed to prevention efforts out of the federal budget calculations.

All of these discontinued efforts were likely to have had a major effect on reducing future generations of Australians from hearing those awful words: you have cancer.

Like any human endeavour that aims for big changes in systems and behaviours, stopping and starting the programs that lead these changes diminishes the prospect of success.

So why is it hard to get governments to invest in prevention?

Strong and influential industries consistently lobby governments to protect their commercial interests. That’s what happens in a market economy democracy. The alcohol, processed food and even tobacco industries continue to exercise an influential voice in the halls of power.

Unsurprisingly, industry aggressively opposes higher taxes on these products (“sin taxes”) and programs discouraging their use.

It is common to hear politicians tell stories of individuals, “real people” who benefit from a new treatment or access to new life-saving medical care or drugs. We all connect with these heart-warming stories and they illustrate the importance of the public funding investment.

Such stories are harder to tell in prevention. How do we find the 64-year-old enjoying his granddaughter’s first day at school, largely because he did not die of a smoking-related disease in his 50s because tobacco control efforts in his youth meant he did not take up smoking?

To tell of our success, we revert to dry and dusty but impressive statistics, with one estimate of 500,000 premature deaths prevented over the past 20 years.

Effective prevention policies, such as putting a minimum floor price on alcohol, work to reduce alcohol-related harm. But making it more difficult to reduce the price of alcohol is politically unpopular.

Reforms such as expanding smoke-free areas are taken for granted now, but were opposed when first introduced.

Tobacco control measures are now accepted and welcomed, but that wasn’t always so.
Patrick Brinksma

Finally, the benefits of prevention often take many years, even decades, to arrive. Political timeframes are often linked to election cycles of three or four years.

A long-term view is vital. Each dollar invested in skin cancer prevention, for example, returns about A$2.20 in cost saving in avoiding cost of treating the disease. But there are decades between reducing kids’ sun exposure and avoiding treatment when those kids reach their 50s and 60s.

As the election campaign unfolds, let’s hope both aspiring Australian governments continue to show a genuine interest in the health of Australians and commit to preventing disease. Is 5% of the health budget too much to ask for that?

Terry Slevin, Adjunct Professor, School of Psychology, Curtin University and College of Health and Medicine, Australian National University and Simone Pettigrew, Professor, School of Psychology, Curtin University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Labor’s cancer package would cut the cost of care, but beware of unintended side effects

Posted on April 8, 2019 by particularkev

File 20190408 2909 1dbbi9k.jpg?ixlib=rb 1.1 — The median out-of-pocket expenses for breast cancer treatment is A$4,192.
ESB Professional/Shutterstock

Kees Van Gool, University of Technology Sydney and Jane Hall, University of Technology Sydney

Labor’s big-ticket election promise is a A$2.3 billion package to provide free medical scans and specialist consultations for cancer patients, plus automatic listing of new cancer therapies on the Pharmaceutical Benefits Scheme (PBS) once they’re recommended by the nation’s expert advisory panel.

One in two Australians will be diagnosed with cancer by the age of 85, and around 145,000 new diagnoses are made each year. So most of us have a close relative or friend who will be affected by the policy.

But there are some important policy considerations a Shorten government would need to plan for to ensure the package provides optimal care, improves patient outcomes, and does actually reduce out-of-pocket costs.

What’s the problem with cancer care?

New therapies for cancer are rapidly evolving, and are often extremely expensive. Seeking treatment involves navigating a complex array of public and private providers across multiple health care sectors, often leaving patients with high out-of-pocket costs.

These costs are highly dependent on which providers the patients choose (and the fees they charge), the level of private insurance cover, and the volume of services used.

A recent Queensland study found the median out-of-pocket expenses for a breast cancer patient, for example, was A$4,192.

It’s possible but very time-consuming for patients to “shop around” to reduce costs. But this is an unreasonable burden to place on patients.

The Labor proposal provides an opportunity to develop a comprehensive cancer control program that encompasses prevention, early diagnosis, treatment and follow-up – at a reasonable cost.

Better care for cancer patients

Cancer treatment is well researched; there are clear evidence-based guidelines that establish clinical pathways for the best treatment.

Nevertheless, there is substantial variation in treatments given to cancer patients. This difference cannot always be explained by their clinical conditions, and sometimes the care is not evidence-based.

It’s important that the proposed reforms do not just fund more care, but support more of the best care.

The approach that has shown promise in other countries is known as “bundled payments”.

Under bundled payments, a series of health care services – that can span over time and across multiple health care sectors and providers – are bundled together for funding purposes. This gives providers or institutions greater flexibility in how they spend money delivering care to the patient.

There is a danger that bundling can provide incentives to skimp on care, because the provider receives the same amount of funding no matter how much care is provided. But this can be addressed by monitoring the quality of care and the patients’ outcomes.

Ensuring the financial benefits flow to patients

Australian governments have made several attempts to provide better safety nets that cushion patients from extra charges.

Study after study shows that, in these circumstances, providers are likely to raise their fees. So while patients get some financial benefit, the doctors benefit also.

Under current Medicare rules, the Australian government does not and cannot determine doctors’ fees. It can only determine the amount of the Medicare benefit.

In general practice, most consultations are bulk-billed implying that the fee the doctor charges is equivalent to the Medicare benefit.

Only 31% of specialist consultations are bulk-billed, leaving more patients with an out-of-pocket payment.

What can government do to encourage cancer care providers to bulk-bill?

Labor has announced they will add a bulk-billing incentive payment, as occurs in primary care. Specialists will receive an additional payment if they bulk-bill a cancer-related service.

This will not guarantee that every patient will not incur any out-of-pocket costs – although it should increase the likelihood that they will. Indeed, the Labor target is that 80% of patients will be bulk-billed.

However, previous research has shown that while the GP bulk-billing incentive led to a reduction in costs for those eligible (concession card holders), it also increased costs for those not eligible.

Careful monitoring is required to ensure the volume of services – and their fees for non-cancer patients – do not go up.

Not all cancer care is based on the best available evidence.
Napocska/Shutterstock

A further unprecedented complication is that for some services, it will be necessary to differentiate Medicare payments on the basis of the patient’s cancer status.

To guarantee patients face no out-of-pocket costs would require more radical reform. Again, the bundled payment system could be a vehicle for such reforms whereby payments are conditional on all the patient’s service providers agreeing to deliver care with no additional fee to the patient.

Depending on whether a patient is privately insured, the bundled payment could be financed by private health funds and Medicare.

Of course, it’s not yet clear that bundled payment schemes can be directly applied to the Australian setting.

The Labor cancer package requires careful and rigorous research effort to inform and guide the policy development.

A new vision for Medicare

Medicare is now 35 years old. It was built on fee-for-service payment, and focused on short, acute episodes of illness.

Now it’s time to move to new funding mechanisms that provide better care for complex, ongoing conditions, at a cost patients and the country can be sure represent efficient use of resources.

Cancer is a good place to start and it could indeed be the most significant reform of Medicare so far.

Imagine a health system where every Australian was assured of optimal care, no matter what their illness or economic circumstances. That is a health system worth paying taxes for.

Kees Van Gool, Health economist, University of Technology Sydney and Jane Hall, Professor of Health Economics and Director, Centre for Health Economics Research and Evaluation, University of Technology Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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How many cancers were overdiagnosed?

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What the study did

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Public hospitals

Cancer care

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Poor track record

So why is it hard to get governments to invest in prevention?

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What’s the problem with cancer care?

Better care for cancer patients

Ensuring the financial benefits flow to patients

A new vision for Medicare

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