Faulty cancer kits-HSE reaction to tests not good enough

Cancer is a leading cause of deaths among men in this country, with more than 2,500 men diagnosed with prostate cancer annually. The risk rises with age, as men of 70 or older are almost seven times more likely to suffer from prostate cancer than men under 50.

It is vitally important, therefore, that men should be aware of the dangers and be checked for early symptoms, because the prognosis is so much better if the problem is detected early. It is disturbing to learn that a flawed test was being used at one of the largest hospitals in the country for over a year.

The Siemens Prostate Specific Antigen test kit — being used as an aid in detecting prostate cancer at James Connolly Memorial Hospital in Dublin — was withdrawn at the end of June, because it was giving elevated readings that were 20% to 23% too high in relation to the World Health Organisation standard. The PSA test, which measures the level of a protein produced by the prostate gland, can provide a warning of cancer, because a high PSA reading may indicate the presence of the disease.

Hence the false readings may have led to a substantial number of unnecessary biopsies. Those would have been stressful for patients and may in some cases lead to urinary tract infections and mild prostatitis. Serious complications may even occur leading to septicaemia (blood poisoning) and even death.

In June, Siemens Healthcare Diagnostics issued a statement recalling the PSA test kits that it issued from Feb 2012 to May 2013. Discrepancies in testing results had already been recognised.

Dr JC Forde of the Urology Department at Beaumont Hospital, Dublin, presented a paper in 2011 comparing six different testing methods being used at nine different hospitals in the country. He found the PSA readings were inflated at eight of the nine hospitals.

Previously, general practitioners had significant leeway in interpreting when test results warranted further diagnostic investigation. But the introduction of the Rapid Access Prostate Clinics in 2011 led to a rigid cut-off point in PSA readings above which doctors automatically sent patients for further investigation.

Many people underwent unnecessary biopsies as a result of high PSA levels on two successive tests that were within the “average positive bias” in the flawed Siemens kits.

One patient informed the Irish Examiner of undergoing PSA tests at Connolly Hospital, which produced very high readings, but when his third sample was analysed under the different system at Beaumont Hospital, the reading was 40% lower. He was angry at the unnecessary stress and anguish that he endured.

The HSE should be upfront and transparent about such mistakes because, when these are exposed first by the media, it inevitably fuels speculation that things are even worse than people fear. There is also an obvious need to ensure that the tests used are carefully analysed in advance.

A faulty system was in place for 16 months, but the HSE is only reviewing tests for two of those months. This is not good enough.