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Posts Tagged ‘population-based screening’

PROSTABLOG NZ: The debate within medical circles about the benefits – or not – of mass screening for prostate cancer just got a little more foggy in NZ.

Parliament’s Health Select Committee inquiry into prostate cancer was due today to hear from Lannes Johnson, medical director for the Harbour Health PHO, who – if a report in last week’s NZ Doctor magazine/website is to be believed – would enthuse about the results of a “new” study just released from Sweden.

Prostablog reported (also somewhat breathlessly) on the Göteborg study back in July after it appeared in Lancet Oncology, pointing to commentary by Mike Scott at the New Prostate Cancer Infolink.

Despite the positive tone of the NZ Doctor article – the majority of whose sources depicted the study as proof that population-based screening is fully justified – Scott’s analysis does not support that.

And neither does an editorial (represented by one paragraph in the NZ Doctor article) by Cambridge University’s Prof David Neal, which appeared at the time of the Lancet Oncology report.

After rehearsing the contents of the Goteborg study, Scott had this to say:

  • This study appears to show clearly that, in a screening-naïve population of men aged between 50 and 70 years of age, biannual PSA testing can lower the risk for prostate cancer-specific mortality by at least 40 percent.
  • In addition, the study shows that the proportion of patients diagnosed with prostate cancer and requiring hormone therapy in the screening group (103/1,138 or 9.1 percent) was much less than half that of the patients in the control group (182/718 or 25.3 percent), implying that early detection also reduced the risk for metastatic disease.
  • However … the study also shows clearly that (at 14 years of follow-up) biannual PSA screening has no impact whatsoever on the overall mortality rate in the same population.

We are therefore potentially faced with the difficult question of whether mass, population-based screening that does affect disease-specific mortality but does not affect overall mortality is justifiable based on the costs, the effort, and the potential harms to the men who are over-treated.

The single most important fact about this study, as far as The “New” Prostate Cancer InfoLink is concerned, is that it finally has provided us with a highly structured, ongoing assessment of the potential value of mass, population-based screening for prostate cancer in a previously screening-naïve population.

The study also includes full treatment information on all men diagnosed with prostate cancer over the course of the study.

This means that at last we have a real baseline against which to assess the data from all other screening studies, and we can use this baseline to recognize the inherent problems of the PLCO and ERSPC studies, which include short follow-up (to date) in both studies, variation in protocols (within the ERSPC cohorts), and data adulteration resulting from PSA testing among the “unscreened” patient cohort (in the PLCO study).

The data from the Göteborg study may still not provide a convincing rationale for mass, population-based screening based on use of the PSA test, but it certainly does set the standard for what must be expected from any new test that may come along and show promise as a true screening test for prostate cancer in the future.

The one regrettable fact about this study is that if it had included just one additional age cohort (of men born between 1945 and 1950), we might have been able to gain real insight over time into the benefits of even earlier detection for a period of up to 30 years.

A much more cautious note here, then, than these comments in NZ Doctor:

“The Government can hardly say they won’t screen for prostate cancer if the science supports it,” Dr Johnson says, referring to an ongoing Parliamentary inquiry into the early detection and treatment of prostate cancer.

Auckland urologist Robin Smart says the bottom line for him is that the study shows prostate cancer screening could prevent 300 of the 600 deaths from prostate cancer that occur every year in New Zealand. “All of the results strongly suggest that PSA screening is a really good idea,” Dr Smart says.

NZ Doctor concluded:

The results of the Göteborg trial are due to be presented to the Health Select Committee next week (today, September 15) as part of its inquiry into prostate cancer. Dr Johnson will talk about the results during a presentation by Harbour Health on PHO capability for reducing the burden of cardiovascular disease, smoking and diabetes.

Let’s hope the committee takes the time to read more widely about the study.

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PROSTABLOG: When can we expect a report from the NZ parliamentary inquiry into the early detection and treatment of prostate cancer, which was launched a little over a year ago?

No word on that from the committee, but perhaps two of the most powerful “words” in the debate on screening were submitted to the committee just before last Christmas (unreported in the news media, so far as I can tell).

They came from eminent pro-screening urologist Robin Smart and from the Ministry of Health’s expert panel, the NZ Guidelines Group, which has been strongly anti-screening (population-based).

Here’s a couple of quotes from Smart’s submission, which discussed the inconclusive results of the two large international screening trials published in March last year:

The conclusion is that it is now very difficult if not impossible to conduct trials of controls having no testing versus screened having PSA/DRE (PSA tests/digital rectal examinations) testing with endpoints of death or metastases in advanced countries especially the United States.

This is largely due to the international improvements in these aspects because of PSA/DRE testing and consequent reluctance of men to remain in control groups.

This in turn means that it is going to continue to be difficult for authorities and governments responsible for making decisions concerning setting up national prostate cancer screening programmes who are waiting for more information before doing so.

These decisions will have to be made largely on current information from existing trials, studies and experience…

The weight of evidence in favour of PSA/DRE testing is now irrefutable after almost two decades of international experience.

To go back to the time before PSA testing would now be unthinkable.

Of course we hope for the perfect tests, perfect treatment and continue to look for improvements. But men today need the benefit of current technology which the evidence shows is saving between a third to a half of those who would otherwise die of prostate cancer where it is applied.

In its final submission (dated the same day as Smart’s, December 16), the guidelines group gave a contrary view.

It looked at nearly 10,000 research abstracts and chose 166 it says were relevant to the brief given to it by the Ministry of Health.

Its analysis concluded that the potential harm from population-based screening outweighs benefits.

The best case scenario it could find estimated that a screening programme conducted on all men aged 50 to 74 for nine years would save about 40 lives a year (from the 600 who die from the disease in NZ each year).

Those 360 lives saved over nearly a decade had to be weighed against the following “harm” that could be done:

  • An estimated 41 men would suffer significant treatment complications for every one life saved.
  • Of the additional 1953 men per year requiring prostate cancer treatment (presumably on top of the 2500 now), 43% to 88% would have sexual dysfunction, 10% to 35% urinary dysfunction and 8% to 43% bowel dysfunction (the range depending on whose research is consulted)
  • Each year, there would be the following additional complications – 838 to 1677 cases of sexual dysfunction; 156 to 838 cases of bowel dysfunction; and 195 to 682 cases of urinary dysfunction.

Meantime, international debate on screening continues.

HERE> is a report on a pro v con panel discussion at the recent American Urological Association annual conference.

And, Mike Scott, sitemaster of the New Prostate Cancer Info-Link in the US, says he agrees with an April article in the Australian Medical Journal that said population-based screening (that is, screening of all men) cannot be sanctioned until something more accurate than the PSA test is developed. READ MORE>

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OPINION

PROSTABLOG NZ: For now, the debate about whether all men should be screened for prostate cancer is dead.

For now.

For sure, it will re-ignite at some future time, as prognostic tests are improved to the point where doctors can tell when  a prostate tumour discovered in a man needs treatment and when it can be left alone.

Why is the debate dead in the meantime?

Two studies published by the British Medical Journal today back up what most analysts have been saying since the March publication of early results of the two big randomised trials that have been looking at PSA/digital testing.

That mass screening will uncover a lot of cancers that are harmless. Over-treatment will result. It has already.

Even the NZ Prostate Cancer Foundation appears to have conceded this is the case.

At last week’s initial hearings by the Parliamentary inquiry into prostate cancer, Foundation president Barry Young said the organisation was “not dogmatic” about screening.

So where does this leave things?

Should we abandon PSA and rectal exams?

Hardly. They are reliable tools for diagnosis and must still be available to men who ask for them, men whose families have a history of prostate or breast cancer, men with symptoms like reduced urination, unexplained pains, blood in the urine, etc.

Where the debate still needs to continue is in the arena of primary health: how can the confusion that appears to reign among GPs and their patients be clarified.

And does all this rule out a marketing campaign urging men to be checked?

No way. It just needs to be done with a clear message.

Not a lot to ask.

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mohPROSTABLOG NZ: New guidelines for general practitioners on how to handle men presenting with possible symptoms of prostate cancer (and other cancers) were released today by the NZ Ministry of Health.  READ MORE> and HERE (summary)>

The advice is contained in a 174-page report from the Ministry-backed NZ Guidelines Group called Suspected Cancer in Primary Care – Guidelines for investigation, referral and reducing ethnic disparities, which sets out background data and guiding principles on a range of cancers.

The report avoids getting into population-based screening – a major issue in detecting prostate cancer – saying:

Cancer screening, health promotion and prevention, case-finding in asymptomatic people, recurrence of a previous cancer and metastatic cancer were beyond the guideline scope and therefore are not included.

However, it does relent a little in the section on ethnicity and cancer treatment disparity:

Addressing the issue of cancer screening is outside the broad scope of this guideline. However, because of the impact that screening uptake can potentially have on disease outcomes, it is briefly included as part of this disparity chapter.

In the section on prostate cancer, it outlines the following advice for GPs seeing patients:

  1. A man presenting with macroscopic haematuria (blood in urine) should be referred urgently to a specialist;
  2. A man found to have an enlarged, smooth prostate on digital rectal examination and a normal PSA should only be referred to a specialist if they have macroscopic haematuria;
  3. An older man presenting with lower urinary tract symptoms (frequency, hesitancy, nocturia) should be recommended to have a digital rectal examination and a PSA test.

Men with erectile dysfunction are excluded from the referral guidelines.

The report also contains the latest data on cancer trends and explores in some depth the detection, care and mortality disparities between Maori, Pacific people and European Kiwis.

On the page listing organisations that endorse the report (so presumably have seen it already), the Cancer Society of NZ (which opposes population-based prostate cancer screening) is included – but not the Prostate Cancer Foundation of NZ (which supports it).

The report comes just a week before the Government’s Parliamentary inquiry into prostate cancer detection and treatment, which will hear its first submissions on Wednesday.

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JULY 3: PROSTABLOG NZ: In what seems to be exquisite timing, NZ’s parliamentary select committee on health is starting an inquiry into prostate cancer screening – just as some of the best recent analysis of screening emerges in the US.

The latest informative discussion comes from Mike Scott at the New Prostate Cancer Infolink website, one of the leading American aggregators of up-to-date information.

As global debate hots up following recent publication in a medical journal called CA: A Cancer Journal for Clinicians of an article about screening and an accompanying editorial, Scott today makes some interesting points:

  • Media reporting of this latest look at the two large randomised studies is well wide of the mark.
  • What the article actually makes clear is we just do not know how best to use the tools currently available to test an individual man so as to ascertain with accuracy his real risk for clinically significant prostate cancer.
  • So — surprise, surprise — we need better tests, as America’s Prostate Cancer Organizations have already clearly stated.
  • A critical element, covered in the article, is the importance of taking account of the patient’s age, life expectancy, family history, race/ethnicity, and other personal health factors in making the decision whether testing for prostate cancer is appropriate or not.
  • The article does not discuss, at all, the potential merits of  “baseline” PSA testing (at any specific age).
  • The journal’s accompanying editorial uses some “loaded” language in making the correct recommendation that regular, mass, population-based screening is not currently justified based on the available evidence. That “loaded” language is centered around the use of the terms “over-diagnosis” and “over-treatment.”
  • There is excellent evidence today that “mass, population-based screening” using mammograms to look for breast cancer is no more justified that prostate cancer screening, on any good statistical basis. Some 2,970 women must be screened once to find 27 cancers and save one life (in women aged between 40 and 65 years of age). The editorial repeats the finding of the European trial that it would be necessary to screen 1,410 men and find an additional 48 cancers to prevent one prostate cancer-specific death.
  • There are simple answers to the issue of “over-reaction” (to screening findings from doctors and patients), and they start with greater honesty — among the clinical community and among the survivor community — about what we really do and don’t know.
  • Over the past 30 years, prostate cancer deaths have dropped 20% in the US, but…”We still can’t tell [which patients are at real risk] beforehand, and so fear and  ‘standard practice’  tell us that we should proceed with treatment ‘to be on the safe side’. We need to do better. And it doesn’t help to demonize the problem with terms like ‘over-diagnosis’ and ‘over-treatment’.”
  • In all truth, we do not have good enough information to allow us to know the best thing to do for the vast majority of men who are at only a statistical (as opposed to a clinically evident) risk for prostate cancer.

It’s to be hoped someone draws the Health Select Committee‘s attention to this latest development in the debate, which has rumbled along since late March, when the results of the long-awaited studies were published in the New England Journal of Medicine – and failed to resolve anything.

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PROSTATE INQUIRY: What’s caused NZ government to revisit prostate screening issue?

JUNE 21: PROSTABLOG NZ: While the hopes of those pushing for prostate cancer screening were buoyed by last week’s NZ Government announcement of a select committee inquiry, the chances anything will change are uncertain.

Politicians, even those with medical backgrounds, must rely heavily on the advice of experts when it comes to health policymaking, and any signs the experts are about to change their views on this complex issue are not encouraging.

Medical people with an interest in prostate cancer have been waiting for most of this century to hear the results of a couple of massive, long-term, random studies on PSA testing and screening, which were expected to prove one way or another whether population-based screening is the right thing to do.

Mention of the trials, in the US and Europe, peppers the research papers of medical academics, especially those most opposed to screening all men, the epidemiologists.

The trial results are now in (published in the New England Journalism of Medicine in March) and those looking for irrefutable evidence either way will have been disappointed. The Australian Prostate Cancer Foundation went so far as to say the trials were flawed and the results suspect.

NZ’s Ministry of Health has been keeping an eye on all this, it says, and one of its committees met last month to discuss these and other recent findings.

The MOH promised a statement after this process, but has kept quiet, and instead the prostate community on June 18 got news of the new parliamentary inquiry.

The announcement, incidentally, came more than a month after the Health Select Committee actually made its inquiry decision, which on Parliament’s official website is dated May 27.Select committee

So what’s happened?

It seems a confluence of the following has produced the right conditions for something to happen, a perfect storm:

•    a new government, Minister of Health, and Health Select Committee;
•    a five-year gap back to the last official review of NZ’s prostate screening policy;
•    the release of the randomised studies’ results;
•    and with that, an upsurge in world-wide debate;
•    the Prostate Cancer Foundation of NZ’s quiet and consistent lobbying in favour of some sort of screening;
•    continuing horrific statistics for Maori men, who die of prostate cancer at twice the rate of non-Maori;
•    and high current interest in prostate cancer from researchers and drug companies, especially in the US.

The political aspect of this development is the most under-reported (NZ media coverage of prostate cancer tends to be sporadic and superficial) and therefore potentially the most interesting.

The Health Select Committee last examined prostate screening in 2006.

The then-committee – comprising MPs Sue Kedgley (chairperson), Maryan Street (deputy chairperson), Dr Jackie Blue, Dr Jonathan Coleman, Jo Goodhew, Ann Hartley, Sue Moroney, Hon Tony Ryall (now Minister of Health), Lesley Soper, Barbara Stewart and Tariana Turia – considered a 2005 petition from ACT MP Muriel Newman (signed by 585 others) calling for a change in screening policy.

After hearing Ministry of Health advice, the committee rejected Newman’s call for population-based screening, but recommended the government develop up-to-date guidelines to assist GPs and their patients make decisions about testing and treatment. The MOH produced these in 2007.

In its report, the committee also said:  “We recommend that the Government evaluate the evidence of the two trials that are presently being conducted into whether screening can reduce the incidence of death from prostate cancer, and re-assess its policies as soon as they are completed.”

In opposition over the past decade, National MPs and one of their natural allies, ACT, have been vociferous in questioning what they saw as lack of action by the Labour-led government.

Many of these parliamentarians – Muriel Newman and NZ First list MP Barbara Stewart notable among them – are now out of Parliament, but two remain who have voiced their concerns in Parliament about prostate cancer.

One is chairman of the new Health Select Committee, former clinician Dr Paul Hutchison, who featured in the House on September 14, 2004, when he pushed then Labour Minister of Health Annette King to concede the Government wasn’t doing enough about prostate cancer.

She conceded nothing, and stuck with her MOH advice.

Here’s how Hansard recorded the exchange:

September 14, 2004: Dr Paul Hutchison to the Minister of Health: Does the Ministry of Health have a view on the value of initiating a ‘prostate awareness’ campaign; if not why not?

Hon Annette King (Minister of Health): Yes. The Ministry supports the views of the National Health Committee which does not recommend prostate screening for asymptomatic men because of its lack of proven benefit and the potential for harm arising from unnecessary radiotherapy, surgery or other treatment at this stage, but we will continue to monitor international trends and research.

The committee has, however, published information regarding issues men need to consider when seeking prostate screening tests in the brochure Checking for Prostate Cancer, Information for men and their families. This brochure is available on the New Zealand Guidelines Group’s website: http://www.nzgg.org.nz.

Hutchison: Is she satisfied that the April 2004 report of the National Health Committee relating to prostate cancer screening provided up to date and best practice advice; if not why not?

King: Yes.

Hutchison: What specific public health programmes are available to alert men to health problems such as prostate cancer; if there are none, why not?

King: There are no specific health programmes to alert men to prostate cancer because routinely checking men without symptoms of prostate cancer is not recommended. However, I refer the member to written question No 13279 regarding the National Health Committee and New Zealand Guidelines Group’s brochure on this issue. For initiatives in other health programmes, I refer the member to written question No 13269 (2004).

Hutchison: What advice does the Health Ministry recommend to men, specifically to help prevent and achieve early detection of prostate cancer, and if not why not?

King: The Ministry of Health endorses the guidance produced by the National Health Committee, which states that men who have concerns should see their GP. These guidelines are available on the National Health Committee website (http://www.nhc.govt.nz/publications.html).

The second is National list MP Dr Blue (another former clinician), who questioned the government in 2006 and 2007.

Here’s how she is recorded in Hansard:

October 16, 2006: Dr Jackie Blue to the Minister of Health: Has any preliminary work been done by the Ministry of Health on the costing and logistics of a prostate cancer screening programme; if so what are the results of any preliminary work?

Hon Pete Hodgson (Minister of Health) replied: In April 2004 the National Health Committee (NHC) published its report to the Minister of Health on prostate screening in New Zealand. The report did not recommend population based screening for prostate cancer. No further work has been done by the Ministry of Health on the costing and logistics of an organised population based screening programme.

Blue: When did PSA or prostate specific antigen testing become available in New Zealand?

Hodgson: The Ministry of Health is not aware of the exact date the PSA test became available in New Zealand. However, statistics in the publication Cancer Trends and Projections indicate that the PSA test was being more widely used from the 1990s onwards.

Blue: How does New Zealand’s current prostate cancer screening guidelines compare to Australia, United Kingdom, United States, Canada and European countries?

Hodgson: New Zealand’s current policy on prostate cancer screening is the same as Australia, United Kingdom, United States, Canada and European countries, and aligns with the recommendations of the World Health Organization.

Blue: Have the interim results of the prostate cancer screening trials involving hundreds of thousands of men in Europe and the United States been made available to the Ministry of Health; if so, what are the preliminary results; if they are not available, when are they expected to be available?

Hodgson: The Ministry of Health is aware of two large randomised trials occurring in Europe and the United States. The first interim results of these studies are expected by the end of this year.

Blue: What resources does the Ministry of Health provide to general practitioners regarding prostate cancer screening; when were they last updated?

Hodgson: The Ministry of Health has published a pamphlet Screening for Prostate Cancer for health care practitioners, which is currently being updated. The pamphlet was produced by the New Zealand Guidelines Group in 2004 and is available on the Group’s website (www.nzgg.org.nz).

Blue: What are the current guidelines for prostate cancer screening; when were these last updated?

Hodgson: There are no New Zealand guidelines for prostate cancer.

February 27, 2007: Dr Jackie Blue: Can the Minister guarantee that updated breast cancer surgical guidelines will be forthcoming, or will it be like the long-awaited update of the prostate cancer guidelines on the Ministry of Health website, which were promised 16 months ago but still nothing has happened?

Hon PETE HODGSON: The guidelines are under development now.

How do others on the eight-member committee stand?

One, Green Party list MP Kevin Hague, has declared his opposition to the inquiry even before it’s begun. The deputy-chair, Ruth Dyson, has on occasion been a defender of Labour’s “no-screening” policy over the past three terms.

The views of the other four might become apparent in a thorough search of Hansard, but are not prominent.

What are those in favour of screening up against as they prepare their submissions for the committee’s hearings, whose terms of reference will be announced this coming Wednesday (June 23)?

One of the strongest opponents is Ann K Richardson, Associate Professor, Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, University of Otago, whose 2005 paper for the NZ Medical Journal said the following:

“The results from autopsy studies and the Finasteride trial are a warning.

“If healthy men have PSA tests, some will be diagnosed with prostate cancer that they would otherwise never have known about, and that would never have threatened their lives. This would be bad enough, but many men who are diagnosed with prostate cancer are offered treatment such as radiotherapy or surgery, and these treatments have significant side effects. The potential side effects include impotence, incontinence, diarrhoea, and death.

“Some of the men who suffer these side effects would never have known they had prostate cancer in the absence of screening, so they will have been directly harmed as a consequence of being screened.

“Although it is possible to understand and perhaps explain opposing views on prostate cancer screening, examining the risks and benefits shows that prostate cancer screening is not justified at present.

“Whether there is any benefit from prostate cancer screening is unknown. It is inappropriate to support screening in the hope that it will be found to be beneficial, since this would be gambling with men’s health.

“Prostate cancer screening fails to meet criteria for screening, and carries potentially serious risks. In the absence of conclusive evidence of benefit, it is entirely possible that prostate cancer screening could cause more harm than good. Therefore, at present, it is unethical to offer prostate cancer screening.

“In the future, screening should only be offered if the randomised controlled trials of prostate screening that are currently underway, demonstrate a benefit.”

The debate about prostate cancer screening has been quiet for a while.

One of it’s most memorable moments came on April Fool’s Day, 2004, when a Ministry of Health-hosted body called the National Health Committee made the following announcement: ‘No, not yet, to prostate cancer screening.’

The question remains: will those who didn’t get the joke then have any reason to laugh sometime later this year when the latest examination of this controversy that won’t go away reports back?

Making submissions to select committee: http://www.parliament.nz/en-NZ/PB/SC/MakeSub/

Email committee chair: paul.hutchison@parliament.govt.nz

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JUNE 14: PROSTABLOG NZ: Ministry of Health officials and their medical advisers have been mulling over findings from the two large randomised studies of prostate screening in the US and Europe, and the ministry is due to make an announcement on the matter soon.

The Ministry has long advised the government that population-based screening has no proven benefits in terms of preventing death from prostate cancer, a stance echoed by the NZ Cancer Society, and some researchers, as well as by governments throughout the world.

Did the two big studies (published in March) find anything that will change their minds? And meantime, what should the average NZ patient do about screening (getting a GP to do a PSA blood test and a digital examination), and what treatment choice should someone make if a diagnosis is positive?

The Harvard Medical School website has a video discussing some of the issues. SEE IT HERE>Harvard

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