In an episode of ABC’s Four Corners this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

What does the evidence say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

What about the harms?

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”.

We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

High costs

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000. With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

It’s not all bad news

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, Professor of Orthopaedic Surgery, UNSW Sydney; Adrian C Traeger, Research Fellow, Institute for Musculoskeletal Health, University of Sydney, and Caitlin Jones, Postdoctoral Research Associate in Musculoskeletal Health, University of Sydney

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

Corporations have used feminist language to promote their products for decades. In the 1980s, companies co-opted messaging about female autonomy to encourage women’s consumption of unhealthy commodities, such as tobacco and alcohol.

Today, feminist narratives around empowerment and women’s rights are being co-opted to market interventions that are not backed by evidence across many areas of women’s health. This includes by commercial companies, industry, mass media and well-intentioned advocacy groups.

Some of these health technologies, tests and treatments are useful in certain situations and can be very beneficial to some women.

However, promoting them to a large group of asymptomatic healthy women that are unlikely to benefit, or without being transparent about the limitations, runs the risk of causing more harm than good. This includes inappropriate medicalisation, overdiagnosis and overtreatment.

In our analysis published today in the BMJ, we examine this phenomenon in two current examples: the anti-mullerian hormone (AMH) test and breast density notification.

The AMH test

The AMH test is a blood test associated with the number of eggs in a woman’s ovaries and is sometimes referred to as the “egg timer” test.

Although often used in fertility treatment, the AMH test cannot reliably predict the likelihood of pregnancy, timing to pregnancy or specific age of menopause. The American College of Obstetricians and Gynaecologists therefore strongly discourages testing for women not seeking fertility treatment.

Despite this, several fertility clinics and online companies market the AMH test to women not even trying to get pregnant. Some use feminist rhetoric promising empowerment, selling the test as a way to gain personalised insights into your fertility. For example, “you deserve to know your reproductive potential”, “be proactive about your fertility” and “knowing your numbers will empower you to make the best decisions when family planning”.

The use of feminist marketing makes these companies appear socially progressive and champions of female health. But they are selling a test that has no proven benefit outside of IVF and cannot inform women about their current or future fertility.

Our recent study found around 30% of women having an AMH test in Australia may be having it for these reasons.

Misleading women to believe that the test can reliably predict fertility can create a false sense of security about delaying pregnancy. It can also create unnecessary anxiety, pressure to freeze eggs, conceive earlier than desired, or start fertility treatment when it may not be needed.

While some companies mention the test’s limitations if you read on, they are glossed over and contradicted by the calls to be proactive and messages of empowerment.

Breast density notification

Breast density is one of several independent risk factors for breast cancer. It’s also harder to see cancer on a mammogram image of breasts with high amounts of dense tissue than breasts with a greater proportion of fatty tissue.

While estimates vary, approximately 25–50% of women in the breast screening population have dense breasts.

Stemming from valid concerns about the increased risk of cancer, advocacy efforts have used feminist language around women’s right to know such as “women need to know the truth” and “women can handle the truth” to argue for widespread breast density notification.

However, this simplistic messaging overlooks that this is a complex issue and that more data is still needed on whether the benefits of notifying and providing additional screening or tests to women with dense breasts outweigh the harms.

Additional tests (ultrasound or MRI) are now being recommended for women with dense breasts as they have the ability to detect more cancer. Yet, there is no or little mention of the lack of robust evidence showing that it prevents breast cancer deaths. These extra tests also have out-of-pocket costs and high rates of false-positive results.

Large international advocacy groups are also sponsored by companies that will financially benefit from women being notified.

While stronger patient autonomy is vital, campaigning for breast density notification without stating the limitations or unclear evidence of benefit may go against the empowerment being sought.

Ensuring feminism isn’t hijacked

Increased awareness and advocacy in women’s health are key to overcoming sex inequalities in health care.

But we need to ensure the goals of feminist health advocacy aren’t undermined through commercially driven use of feminist language pushing care that isn’t based on evidence. This includes more transparency about the risks and uncertainties of health technologies, tests and treatments and greater scrutiny of conflicts of interests.

Health professionals and governments must also ensure that easily understood, balanced information based on high quality scientific evidence is available. This will enable women to make more informed decisions about their health.

Brooke Nickel, NHMRC Emerging Leader Research Fellow, University of Sydney and Tessa Copp, NHMRC Emerging Leader Research Fellow, University of Sydney

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