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Posts Tagged ‘NZ Guidelines Group’

PROSTABLOG NZ: It’s almost a year since the first hearings were held by the NZ Parliament’s Health Select Committee inquiry into the early detection and treatment of prostate cancer.

The obvious question now is when will it report back.

Since it published its terms of reference in August last year, the committee has received 33 submissions, four of them from the influential health lobby group, the NZ Guidelines Group, whose last submission was made in December.

This document made it clear that the group – an independent incorporated society originally set up by the government in 1996 – is opposed to population-based PSA screening.

To save one life, up to 41 men could incur significant harm.

It bases this view on its assessment of numerous NZ and international studies, including two large randomised trials (one European, the other American) that were reported last year.

Here are some of the last pages of the group’s December, 2009, submission (RCT = random controlled trial):

This also appears to be the main thrust of submissions on PSA testing from other health authorities (although the Guidelines Group is at pains to stress it is independent from the Ministry of Health).

Another “official” organisation, the National Health Committee, said in its submission (August 26, 2009) that it has seen nothing to change its 2005 advice to the MOH that population-based PSA screening is not an acceptable option.

However, it did favour targeted screening of high-risk groups, such as men with a family history of prostate cancer.

The NHC is aware that since providing its advice in 2005, clinical practice has found
that targeted screening for men at high risk of prostate cancer appears to be useful
and potentially cost effective. These are men who have a family history of prostate
or related cancers.

The Royal NZ College of General Practitioners – presumably speaking on behalf of doctors on the frontline – said in its submission it would go along with the NZ Guidelines Group’s views.

It did make a couple of pleas, however, calling for up-to-date information to hand out to patients, and for treatment to be available to all:

It is important that inequities in access relating to follow up after positive
screening results, and for symptomatic men, are identified and eliminated.

The Cancer Society agreed with the Guidelines Group, and backed this up by quoting from selected organisations in other Western countries.

Most agencies around the world have some form of recommendation that decisions for screening for prostate cancer should be made on an individual basis and in consultation with a medical professional:

The Australian Cancer Council states that:
“In the absence of direct evidence showing a clear benefit of population based screening for prostate cancer, a patient centred approach for individual decisions about testing is recommended. Screening discussions and decisions should always include and take into account, age and other individual risk
factors such as a family history of the disease” (Cancer Council Au 2005).

The American Cancer Society states that:
“The American Cancer Society (ACS) does not recommend routine testing for prostate cancer at this time. ACS believes that doctors should discuss the pros and cons of testing with men so each man can decide if testing is right for him. If a man chooses to be tested, the tests should include a PSA blood test and
DRE (digital rectal exam) yearly, beginning at age 50, for men at average risk who can be expected to live at least 10 more years.” (American Cancer Society 2009).

The UK Cancer Research Council states:
“in the UK, there is no national screening programme for prostate cancer because trials have not yet shown clear evidence that screening will reduce deaths from this disease. Also, many men diagnosed with
prostate cancer have very slowly growing cancers that will never cause any symptoms or problems in their lifetime. So at the moment there is no clear benefit in diagnosing prostate cancer early and it may actually cause harm for some men.”(Cancer Research UK 2009).

Urological Society of Australia and New Zealand states:
“Individual men aged 50 to 70 years with at least a 10 year life expectancy should be able to be screened by annual DRE and PSA testing, after appropriate counselling regarding the potential risks and benefits of investigations and the controversies of treatment.”(Urological Society ANZ 1999).

The majority of submissions – from prominent medical practitioners, prostate cancer lobby groups and patients – urged the committee to recommend PSA testing, if not on a population (all men) screening basis, then at least as a service offered routinely by GPs, without men having to ask (the current MOH policy).

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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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PROSTABLOG NZ: The battle lines were drawn at yesterday’s first hearing of the  NZ Parliamentary inquiry into prostate cancer – “vested interests” versus those who guard the country’s public medical system.

The former group, apparently, comprises prostate cancer patients and some medical professionals who operate in the field of prostate cancer; the latter, the NZ Guidelines Group, a committee from the medical fraternity and bureaucracy on whom the Ministry of Health relies for expert advice on health policy.

According to the Guidelines Group, the vested interests (a term they used at today’s hearing before the Health Select Committee) must be excluded from the process of deciding how or whether prostate cancer testing should be funded and implemented.

InquiryDay1 1

PROSTATE INQUIRY: Barry Young gives his submission.

This proposition alarmed some members of the select committee, who asked if the reference to “vested interests” referred to drug companies or other commercial interests who might benefit from prostate screening and testing.

The Guidelines Group – represented by chair Professor Cindy Farquhar, chief executive Steve Caldwell and a Nelson GP, Dr Jim Vause – seemed reluctant to spell out exactly what they meant, but when pressed conceded it was, in part, people who suffer from the disease being discussed.

It was a crucial moment at yesterday’s hearing, a three-hour session during which the committee of MPs heard evidence from mostly those in the “vested interests” corner – prostate survivors and their medical advocates.

It threw into sharp relief the attitude of those whose opposition to screening and testing have influenced the government’s position on prostate cancer for more than a decade, a decade during which medical science has moved rapidly to outflank some of their views.

The battleground was forcefully defined from the start of the hearings, when Prostate Cancer Foundation president Barry Young (see video) gave a passionate outline of what he termed the unnecessary loss of men’s lives because of confused communications between the Ministry of Health, GPs and patients.

He and Professor Brett Delahunt – an eminent Wellington pathologist who specialises in urology – claimed earlier attempts (in 2004) by the NZ Guidelines Group to produce policy on prostate cancer testing were a fiasco, which dishonestly misrepresented the outcome as the consensual work of the specialists involved (who included Delahunt).

The MPs were taken aback by these claims and will provide the Guidelines Group with a recording of what Young and Delahunt said so the group can respond (interestingly, the Guidelines people were last up today, so they didn’t attend the earlier submissions to hear what was said).

InquiryDay1 2

Health Select Committee chair Paul Hutchison (right) guides the hearing.

All the submissions yesterday were effective.

Three prostate survivors – one a former medic with the NZ army in Vietnam – gave different perspectives on their experiences, and were questioned closely by the MPs on what they think the committee can do to meet the challenges.

The most affecting presentation came from Kim Cook (Mary on this blogsite), whose story about partner Brian’s saga with advanced prostate cancer deeply affected those listening to her by teleconference.

RoyVeteran MP Eric Roy (right) could be seen wiping tears from his eyes, and most in the room were not far removed from such a show of emotion.

Kim’s efforts to empower herself in the face of a seemingly implacable medical profession were accorded great respect by the committee.

As second man up, Barry Young told the committee that “some members of the medical profession have not distinguished themselves at all” in the way they have dealt with prostate cancer.

“The attitude of some members has indeed led to the death of men in this country,” he said. These were men who had been refused the option of PSA tests or rectal exams or both.

When men came to the foundation in desperation in such circumstances, the foundation’s advice was for them to find another GP.

“We need an education programme not only for the public but for the medical profession as well.”

He was critical of the process used by the Ministry of Health to formulate its policies on prostate cancer screening.

He described an earlier instance when he and prominent prostate specialists were invited on to a Ministry-funded committee to investigate research and best practice.

When it was completed, the committee was disbanded and to his alarm the Ministry’s advisors declined to have the resulting policy peer-reviewed.

“None of us recognised a single paragraph of the policy report that was produced. I can understand why GPs are confused.”

Later, he was asked by Eric Roy why some GPs were not offering screening.

“I think it’s because they are confused. Even the information given to urologists is less than clear. We need to remove the ambiguity – from the medical profession, from the Ministry of Health.”

BrettDelahuntBrett Delahunt (left) was even more condemnatory of the Ministry’s policy advice process, describing the last instance by the NZ Guidelines Group in 2004 as a “fiasco”.

He was invited onto that review committee late in the procedure and went to its last two meetings.

He felt his views and those of other specialists involved were largely ignored.

“The recommendations of the Guidelines Group [for GPs not to recommend PSA testing to asymptomatic male patients] were not a consensus. They were inflicted on the committee after the meetings.”

The problem with such a policy was that in most cases, by the time men showed symptoms, the cancer had spread and metastasised, which meant it was too late to treat them: “If you wait for symptoms to occur you’ve left it too long.”

The PSA (prostate-specific antigen) was the most sensitive of all cancer markers. The false negative rate was “quite low” if the procedures were properly handled.

What the clinician should look for is change in the level of PSA. If the level began to double in less than a year, the approach should be aggressive.

He believes it is now possible to tell the difference between indolent and aggressive tumours.

He described the confusion initially caused when researchers used data including the early use of the Gleason score (for cancer aggression) which once included grades 1 and 2.

It has since been found that samples showing such low scores were not cancers at all (so the Gleason scale no longer includes them), but treatment and mortality data used to compare trends had been muddied as a result.

He said other governments (Canada, US and some in Europe) show a much more positive approach than New Zealand’s to screening and to making men aware of the dangers of slow-growing prostate cancer.

Evidence of the success of opportunistic screening (as opposed to population-based) was now overwhelming.

Hutchison2Chair Paul Hutchison (right) asked for elaboration about Delahunt’s Guidelines Group comments, saying he was under the impression the group was independent and very anxious to take an evidence-based approach.

Delahunt: “That’s fair – but the evidence base was out of date.” He also said he became a member only through accident, after a colleague in Australia mentioned to him the process was under way and asked why he was not part of it.

He said when the group’s guidelines were published his name was listed on the document, something he objected to, since he disagreed with its negative tenor: “There was an element of dishonesty in the Guidelines Group thanking us for the work done.”

DysonChallenged by MP Ruth Dyson (left) on what she perceived to be an allegation the medical profession was deliberately not doing its best, Delahunt said he did not believe anyone went out of their way to deter men from being diagnosed.

His assertion was that some men with the potential to have the diagnosis and cure were missing out.

Asked by Green MP Kevin Hague who should make the decision about a screening programme, Delahunt said he was not proposing a national population-based programme. The need was to encourage opportunistic screening.

“This committee should tell the medical profession there is a need for more clearcut guidelines.”

Hutchison asked who would be in a position to achieve that.

Delahunt: “A balanced group could be appointed.”

Later, he added that some men were not getting a fair deal. Roughly the same number of men died from prostate cancer as women from breast cancer.

The Guidelines Group trio was last to speak (rather mysteriously “welcomed back” by the committee), with GP Jim Vause leading the committee through a series of PowerPoint slides.

These included simplified graphics illustrating what he perceived to be the main thrust of results from the two randomised studies: ie. that many men (more than 1400) need to be screened for prostate cancer before a single life is saved.

He did not mention that many more women (thousands) need to be screened for breast and cervical cancer before their single lives are saved.

Hutchison pointed out that there were known problems with the two trials. Vause said he would get to that later, but didn’t.

He showed that the NZ prostate cancer death rate has been stable since 1961, but that since the early to mid-1990s, the number of diagnoses has risen steeply.

He put that down largely to the prostate awareness programme (but Bret Delahunt would give a big share of the credit to the introduction of the PSA test in 1993).

He was at pains to warn of the risks of treatment – especially death.

A key slide shown to the committee said: “[There is a] need for presenting information free of bias from vested interests in an (sic) manner that a man can understand.”

He said he believed the key point in all this is informed consent.

Cindy.Guidelines Group chair and surgeon Cindy Farquhar (right) said it was vital to have reliable evidence when introducing a new strategy.

This involved trade-offs between:

  • benefits of intervention (in this case a screening programme to detect early prostate cancer);
  • risk of the intervention (harms from the additional biopsies, downstream treatments);
  • cost of intervention;
  • patient preferences.

She mentioned the downside of “just doing it”, listing three examples from the past when such an approach proved  disastrous.

Her last slide elaborated the Guideline Group’s processes:

  • systematic approach;
  • researchers with expertise in clinical studies, critical appraisal, combining studies, developing recommendations, grading evidence;
  • developing guidelines – how to apply the international evidence to the NZ health sector.

The main message from her group was that its review of the two overseas studies (reported in the New England Journal of Medicine last March) was still going on and would not report until November.

Hutchison asked for an assurance that would be done on time, got it, and said the committee would look forward to hearing from the group once that had happened.

The MPs were impressive during yesterday’s hearing.

It was obvious they had done their reading. Their questions showed they have a sound grasp of the issues they must somehow try to resolve.

In the end, it came down to a couple of straight-forward questions:

  • How can the confusion that seems to abound between patients and doctors over prostate cancer be resolved?
  • What can be done to break through Kiwi males’ “I can tough it out” attitude to getting themselves checked out?

The committee made it clear that sorting out the vast morass of conflicting data about prostate cancer detection and treatment is not its job – it will probably recommend this be done by a truly independent group representing all stakeholders, “vested interests” and all.

The only thing everyone seems agreed on at this stage is that population-based mass screening of all men for prostate cancer is not a starter.

But neither is the status quo acceptable. Leaving men without symptoms out of the equation (the medical bureaucracy’s current stance) won’t do.

FOOTNOTE: Committee chair Dr Paul Hutchison said after the hearings that he would write to Barry Young and ask him to provide details to the Health and Disability Commissioner of any cases the foundation knows about of men being refused PSA tests by their GPs.

NEWS COVERAGE of the hearing

NZPA : Hundreds of men are unnecessarily dying of prostate cancer every year because doctors refuse to test them, a parliamentary select committee has been told.  READ MORE>

TVNZ: New Zealand specialists say men as young as 40 should have regular prostate checks, because they believe waiting until 50 is just too risky. READ MORE>

RADIO NZ: Parliament’s health select committee has distanced itself from accusations some doctors are responsible for the deaths of hundreds of men from prostate cancer. READ MORE>

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mohPROSTABLOG NZ: Maori and Pacific people living in NZ suffer big disparities in the way cancer is detected and treated, and how well they survive it. READ MORE>

This has been known for some time, but the problem is newly highlighted in the Ministry of Health-funded cancer guidelines for GPs that have just been released.

For example, it reminds us that as many as 17% of Maori cancer cases and 6% of deaths are never reported.

It also points out that health statistics tend to be five years old before they are published, which suggests that in the rapidly changing detection/treatment environment for prostate cancer, decision-making on how best to screen and treat is seriously hampered by lack of knowledge.

While the overall, 174-page report, avoids discussion of population-based screening, it does touch on the issue in the ethnicity section:

Cormack et al. noted that national screening programme data have identified that equitable screening for breast and cervical cancer has not been achieved for Mäori women.

However, BreastScreen South Limited’s results (70% of eligible Mäori women screened in 2005) suggest that the inclusion of focused efforts and leadership are the key to achieving equity in screening.

The report analyses available data on ethnic disparities in cancer detection and treatment, and makes a number of suggestions, including more “cultural competence” training for health workers.

For the full report, CLICK HERE>

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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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tony ryall_29JUNE 5: PROSTABLOG NZ:  Prostate cancer is a priority for the new National Government, says Minister of Health Tony Ryall (right).

The fact prostate cancer is not specifically listed as one of the six new Health Targets does not mean the issue is no longer a priority, he says in reply to a query from Prostablog.

He was asked to explain why prostate cancer did not rate a mention when he announced six new Health Targets in May, after he told media in January that prostate cancer was a priority for the Government.

“The health targets I announced focus on six measurable targets, one of which is shorter waiting times for patients needing radiation therapy,” he says in a letter received by Prostablog author Jim Tucker today. “Therefore some men with prostate cancer will benefit from this new target.”

The Cancer Control Strategy was still in place with its focus on improving services for all types of cancer.

The work on prostate cancer included the provision of good information for men considering having a PSA test.

“There are differing opinions about the value of population screening of men without symptoms using PSA testing,” says Mr Ryall.

“NZ’s present policy on screening our population for prostate cancer is the same as those of Australia, the UK, the US, Canada and European countries, and aligns with the recommendations of the World Health Organisation.”

Analysis of data on PSA testing volumes and practice in NZ showed that about 50% of men in the older age group were already being tested “on an opportunistic basis”.

This was comparable to participation rates in screening programmes in other countries.

“The Ministry of Health continues to review the international evidence about PSA screening, including the latest evaluations of tests and screening programmes,” he says.

The NZ Guidelines Group, with the Royal NZ College of GPs, had developed a resource called Testing for Prostate Cancer: a consultation resource, which aided the discussion between a man and his general practitioner as part of a consultation.

The advice provided in the resource was consistent with international approaches and advice (see MOH website: www.moh.govt.nz )

Mr Ryall says the MOH and the Health Research Council were planning research into prostate cancer treatment outcomes in NZ: “When completed, this research will provide quantifiable data around successful treatment and any detrimental side effects.”

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