Much of the discussion around health care reform, whether in Australia or the US, seems to be based upon an assumption that more medicine is better.
This recent article at The Drum by the ABC’s Michael Brissenden doesn’t quite get to the crux of the problems with the US system of “Cadillac care” (ie that a specialist-driven health system doesn’t deliver the best population health outcomes, quite apart from the costs involved).
Prostate cancer screening is an example of how too much medicine can be to the detriment of the public’s health, according to a Melbourne cancer specialist, Dr Ian Haines. He writes:
“The discovery of the Prostate Specific Antigen (PSA) test 40 years ago fostered the dream that early detection of prostate cancer would dramatically reduce the death rate from this leading killer of mature men.
In the ensuing 40 years, tens and probably hundreds of millions of men have had the blood test. A vast number of these men have been diagnosed with prostate cancer as a result of the test and have proceeded to have debilitating treatments such as radical prostatectomy or high-dose radiation with the frequent associated side-effects of life-long impotence and incontinence of urine. Current projections are that if we continue to screen for prostate cancer that almost 20% of men will ultimately be diagnosed with it.
These men were all led to believe that their early diagnosis and treatment, with all its associated suffering and side-effects, had saved their lives. Some were high-profile politicians, media figures and sports stars and wanted to share their incredible luck with the rest of us. The media and blogosphere has been bombarded by these people and their surgeons exhorting all males to have the test regularly in the belief that it may save lives. But after 40 years, despite the general belief that this test was improving public health overall, it had never been proven scientifically.
Unfortunately, the two large and definitive randomised clinical trials designed to properly assess whether this test (that many Australian men over 50 years old have had performed at least once) can significantly reduce the death rate from early prostate cancer were published in 2009 and have shown close to zero benefit for having the test (see here and here).
The results confirmed the long-held views of many clinicians that 85% of all prostate cancers are so low grade and slow-growing and indolent that they will not cause a problem to the patient even if he otherwise lives to a 100 years old. Patients with these cancers have been filling our x-ray departments, hospital beds, operating theatres and outpatient, GP and specialist waiting rooms for 40 years having biopsies and operations and then lifelong treatments and counselling for complications of their unnecessary treatments. Is it any wonder that our hospital beds and GP clinics are full to overflowing? And the first baby-boomers are still only 65 years old. What will it be like in 10 years?
Ok you say, all those traumatic and unnecessary biopsies and operations are acceptable “collateral damage” for those 85% if it means that we are curing some of the remaining 15% of men with the more aggressive and potentially lethal prostate cancer with our debilitating treatments.
Unfortunately it does not achieve that. Almost all of those 15% will still die of their cancer irrespective of how early it is diagnosed and how aggressively it is treated.
Overall, one of these two trials from the USA showed that no-one benefits from treatment of early PSA-detected prostate cancer and the other large European study showed that for every 48 men who have radical surgery for the disease, one will be prevented from dying of the cancer and 47 will have incurred no benefit but all the side-effects from the treatment.
Some, including many with a vested interest, will argue with the methodology in these trials or use emotive diversions such as “cadavers never complain of impotence” but the facts have changed and irrespective of what we used to hope and believe, we now have to accept that early diagnosis and treatment of prostate cancer is debilitating, both physically and emotionally, as well as very expensive and, most importantly, ineffective. The much awaited PIVOT (Prostate Intervention Versus Observation Trial) results may change that but as it now well past its potential early stopping points, that appears unlikely.
Ah! say some urologists, but the new (and much-hyped and very expensive) robotic surgery is more effective and has fewer side-effects. Unfortunately a major study from Harvard University in 2009 showed that even though the immediate post-operative course was less complicated, the major long-term side-effects such as impotence and incontinence were actually MORE frequent after ‘minimally invasive robotic surgery.’
In addition, more detailed and sophisticated assessments of patients before and after any radical prostate surgery have shown that the incidences of severe incontinence and impotence are actually far higher than previously believed, especially for men who had no pre-existing problems in these areas. The results discussed here have moved some academics to call for a radical change to how we screen for and treat prostate cancer.
Professor Anthony Zietman, a radiotherapist from Harvard University, wrote in an editorial in the Journal of Clinical Oncology in 2009 entitled “Evidence-based medicine, Conscience-based medicine, and the management of low-risk prostate cancer”:
Delayed treatment remains an option should the cancer ever prove the need. The evidence is mounting, the advocates of surveillance are finding their voice, and the economic incentives are changing. I am optimistic that we can break our cultural addiction to immediate treatment for all and move toward discriminating, selective, and more socially responsible behavior in this challenging disease. Sadly, it may take structural changes to our physician reimbursement system that currently incentivizes intervention and high technology before we see any substantial shift in practice patterns.
Professor Richard Ablin from Arizona University, the person who discovered PSA, wrote an op-ed in the New York Times on March 9, 2010: “The test’s popularity has led to a hugely expensive public health disaster… The test is hardly more effective than a coin toss. As I’ve been trying to make clear for many years now, P.S.A. testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t. I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster. The medical community must confront reality and stop the inappropriate use of PSA. screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.”
He then asked: “So why is it still used? Because drug companies continue peddling the tests and advocacy groups push “prostate cancer awareness” by encouraging men to get screened. Shamefully, the American Urological Association still recommends screening, while the National Cancer Institute is vague on the issue, stating that the evidence is unclear”.
Regrettably, this sounds awfully like the position of our Australian Urological Society of Australia and New Zealand PSA testing policy 2009. In Australia, we even have “Movember” for a month every year to make sure no male avoids their “PSA punishment”.
I am yet to meet a urologist who has had a radical prostatectomy himself although there must be some somewhere. However, I do know that most oncologists I speak to will not have a PSA themselves. Fifteen years ago a relative of mine was very strongly advised by his urologist to have a radical prostatectomy for his biopsy-proven prostate cancer. With my advice and advocacy he declined. He is now on hormone therapy for a suspected isolated bone metastasis but remains very well, independent, continent and was, until commencing hormone therapy, sexually active and potent.
Regular PSA testing of otherwise asymptomatic Australian men has been a public health disaster that threatens to consume vastly more of our precious health dollars in the next twenty years. In the future, for the sake of Australian men and their families and our health system, I hope that more and more men will be given the correct information on PSA before agreeing to board ‘the PSA roller-coaster’ because it is extremely difficult to disembark once you are strapped in.
For many of those lured onto this roller-coaster, I hope that they will be offered the option of “watch and wait” if they are diagnosed with early prostate cancer in the future.”
• Dr Ian E Haines is a physician at Monash University at Cabrini Health, Malvern, Victoria
I’m intrigued by your comment Ian that “most oncologists I speak to will not have a PSA themselves.” I recently tried to survey the membership of COSA (the Clinical Oncology Society of Australia) about members’ cancer protective behaviours (including PSA testing) but unfortunately received a disappointing response rate from men, leaving a cloud above this question. This Victorian study shows 45% of male drs aged 49+ have been tested http://www.ncbi.nlm.nih.gov/pubmed/12036219 but a 2006 US study shows 95% of urologists and 78% of non-urologists have been tested there.
Is this any more than an impression?
Simon
Ian Haines asked me to post this comment on his behalf: “Thank you for the question Simon and for your ongoing and important contributions to the research and discussions about this important topic. My impressions are purely anecdotal and based on conversations within my circle of oncologists. I think it would very interesting to see how many responses you receive, if you put the question again via COSA, and what those responses would be It would also be interesting to compare how many doctors pursue screening for bowel cancer, for which there is high-level evidence for benefit,with whether those same doctors have a PSA for which there is no good evidence.”
The screening for Bowel Cancer is a little bit messier and therefore more complicated than the PSA screening. So a direct comparison is not all that good.
Much easier for a oncologist or urologist to grab a quick PSA test at work on a whim than to grab a quick FOBT or Colonoscopy.
Well except I guess if the rates screening were higher for Bowel Cancer.
Ian Haines’ comment is prefaced by the following: “Much of the discussion around health care reform, whether in Australia or the US, seems to be based upon an assumption that more medicine is better.” Yes – but better for whom?
As someone who quickly stepped off ‘the PSA roller coaster’, might I suggest some research on EBM and SID (supplier induced demand).
1. On EBM I hypothesise that urologists will have reduced their PSA testing in the wake of the publication of the results of the two trials in 2009.
2. On SID I hypothesise that urologoists will not have reduced their PSA testing in the wake of the publication of the results of the two trials in 2009.
The evidence must be there to test these hypotheses.
Hi Gavin, perhaps I should have made my meaning a little more explicit at the start… I meant: a “misplaced” assumption that more medicine is better for the population’s health…Cheers, Melissa
I think that occult blood screening for bowel cancer has been demonstrated to provide some benefit in terms of outcomes.
This is in comparison to PSA testing. Although I am a doctor I still seem to be able to become recurrently confused by this test. I try to explain to patients the pros and cons of the test but most seem to have already made up their mind before they see me. They still want it. I imagine that they would rather know than not know, yet they could be doing themselves harm by having it. People have their radical prostatectomy and then think they have been “cured”, or they know of someone who has.
For me, I would rather not have it. And if it has not been shown to have benefit why are we still doing them even if the patient asks for it, because if they ask for it this would likely imply that they do not understand the test, and so how can they give informed consent?
Anyone seeking to ascertain the viability of the conditional PSA tests bulk-billing terms ought to peruse 18-01-10 dated attachment received by me on 22-01-10 within the email dispatched from Canberra as a consequence of my complaint emailed to the Minister for Health on 15-11-09. Incredibly though, respondent claimed that she replied to 18-01-10 dated email, supposedly received on the day of her “prompt response”! To find out all about the shocking state of affairs have a look at … http://blogs.crikey.com.au/croakey/2009/09/24/for-another-view-on-prostate-cancer-screening/#comment-830
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Australian Government
Department of Health and Ageing
GPO Box 9848 Canberra ACT
Tel: (02) 6289 1555
Fax: (02) 6289 8509
Mr Leo Braun
conscientious_citizen@yahoo.com.au
Dear Mr Leo Braun
Thank you for your email of 18 January 2010 to the Minister for Health and Ageing, the Hon Nicola Roxon MP, concerning Prostate Specific Antigen (PSA) blood testing prostate cancer. The Minister has asked me to reply on her behalf.
The Pathology Services Table (PST) of the Medicare benefits Schedule lists the pathology tests for which Medicare benefits are available, their Schedule fees and conditions for use. The Government is advised on the composition of the PST by the Pathology Services Table Committee (PSTC) which includes experts in pathology from private industry and public hospital practice. The Committee keeps the Table under review to ensure that the services, fees and conditions for use are appropriate, and consults with professional and other expert groups on these issues.
In order to encourage pathology providers to bulk bill, from 1 November 2009, the government introduced new bulk billing incentives for all pathology episodes at a cost of $348 million over four years. This will encourage pathologists to maintain their current high rate of bulk billing.
Under the Medicare Benefits Schedule, medical practitioners, including pathologists, are free to set their own value on the services they provide. While the government is responsible for setting the Schedule fee on which Medicare benefits are based, there is nothing to prevent pathologists or any other medical practitioner setting fees that exceed those in the Schedule. The government encourages bulk billing, but it is at the provider’s discretion whether or not to bulk bill.
The government encourages medical service providers to discuss with patients the likely costs of all their treatment. If you are dissatisfied with the billing arrangements from your current pathology provider, you may wish to consider asking your doctor to refer you to a pathology provider that bulk bills. Patients are entitled to chose their own pathology provider, so I hope that you can feel comfortable asking your doctor to refer you to a provider who better meets your needs.
From the information provided in your email it is not possible to determine which item numbers your tests were billed under. However, I am able to provide information on items which are applicable to the tests you had. There are four items on the Medicare Benefits Schedule for the quantitation of PSA — items 66655, 66656, 66659 and 66660.
Item 66655 is the standard item providing a rebate for a PSA test if there is no previous diagnosis of prostatic disease and is restricted to being claimed once in a twelve month period. Item 66659 is a follow up item to 66655 if a PSA result lies in the equivocal range of the particular method of assay used to determine the level. The range applied is dependent on the method used and the age of the patient, since PSA levels will vary with these factors.
Items 66659 and 66660 are more in-depth tests that can be used when an initial PSA result is not conclusive. Item 66659 can be claimed once in a 12 month period and item 66660 can be claimed four times, it is used when initial test returns a result well outside the normal range.
Item 66656 is the test used in the monitoring of previously diagnosed prostatic disease and there is no restriction on the number of items this test can be claimed for a Medicare rebate in a 12 month period providing that the treating practitioner deems it to be appropriate.
It is not clear from your letter whether you have in fact been diagnosed with prostatic disease. If that is the case, then you should have been billed for either item 66656 or item 66660. In order for the pathology provider to bill the correct item number, they need to be provided with sufficient information in the clinical notes on the request form. You may like to discuss this with your requesting practitioner and ask them to make it clear to the pathology provider that you have previously been diagnosed with prostatic disease (if that is the case). You may then wish to discuss with the pathology provider having your account amended to reflect the correct item number.
In clarifying the information provided by QML in their May 2009 newsletter on their website, prior to 1 May 2009 three items were available for PSA testing on the PST of the Medicare Benefits Schedule — items 66655, 66656 and 66659. Item 66659 provided for one test of PSA fractions in a 12 months period, if a previous PSA test was equivocal.
The changes introduced on 1 May 2009 clarified the conditions that define an equivocal result. Item 66659 now provides for follow-up testing of PSA fractions when the initial result lies within a certain range. The range applied is dependent on the method used and the age of the patient, since PSA levels will vary with these factors. In addition, item 66660 was introduced to allow for up to four tests of PSA fractions within a 12 months period if each follows a total PSA result that is in a higher range but still not definitive.
For your information, Australia does not have an organised prostate cancer screening program. In determining whether there is sufficient evidence to establish an organised screening program, the Government has developed a Population Based Screening Framework, based on the World Health Organization (WHO) screening principles, to provide guidance for decision makers when considering potential population based screening programs in Australia. Currently, there is limited evidence to indicate improved health outcomes or a mortality decline to benefit from routine prostate cancer testing through a national population based screening program, using either the Prostate Specific Antigen (PSA) test or any other available method.
There is no generally accepted population screening test for prostate cancer. Research has shown that screening for prostate cancer using existing test options would result in frequent false positive results (a positive result when there is actually no cancer present) leading to unnecessary patient anxiety and treatments that may affect patients’ health, including sexual, urinary and bowel dysfunction. Researchers continue to seek better ways of detecting prostate cancer at an early stage. The decision to undertake a PSA test is a personal choice to be made by men, in consultation with their doctor, who can advice on the risks and benefits of testing in relation to their specific circumstances.
In the future, it may be advisable for you to contact the provider or discuss the items with your referring practitioner to identify the conditions for Medicare rebates. I assure you that the Government is committed to making high quality and affordable healthcare, available to all Australians. I hope this information has been useful to you.
Yours sincerely
A/g Assistant Secretary
Diagnostic Services Branch
18 January 2010
I have immense trust in Ian. he was my wife’s oncologist over the last five years during her battle with breast and ovarian cancer. Ian won our admiration for his professionalism, friendship and consideration for his patients. He became our trusted friend and companion in our fateful battle with cancer. He ensured that my wife (Madeleine) maintained to the utmost her quality of life, despite the odds of beating both genetic breast & ovarian cancer. Thank you Ian.