Are your patients involved in a clinical trial?

A 90-year-old patient of mine has given me two invitations sent to her by her surgery and signed by her GP, to participate in the STAREE trial.
She has (one year ago) diagnosed early-onset Alzheimer’s and was unsuccessfully given one of the usual drugs which worsened her mental state.
Interestingly, before that prescription was offered, she was also invited to join another trial, but when she asked the geriatrician if he would recommend his own mother to participate, his reply was “no way!”

Anyway, the STAREE trial is the fancy name for “STAtins in Reducing Events in the Elderly”.
I wonder if there’s a special research department that comes up with these names?
The letter she received was lovely.
It pointed out the value of participating and helping others – the perfect pitch to the older Australian!

The STAREE Study is a world-first clinical trial investigating the effects of using statins for the prevention of dementia, heart attacks, strokes, and the need for long-term residential care in people aged 70 and above” says the opening paragraph.
A noble gesture?
Or a sweet-talking con-job?

This patient of mine is on low-dose thyroid hormone, low dose Atacand from the GP and from me, krill oil 1000mg, Strath tonic, magnesium capsules, cranberry and ginseng.
Her health, at 52 Kgs, is reasonable.
Her physical state is sound for her age, and she is quite mobile.

She lives independently but the GPs call at her retirement village on an every-changing basis from within their group clinic.
Ten years ago, one GP insisted on a statin, until I intervened.
When commenced, her confusion became more apparent, especially with the additional anti-cholinergic for bladder issues.
The latter was ceased after two days – her confusion was out of control.

The first STAREE invitation came last year.

Just last week, she was seen by a different GP from the clinic.
No offer of a statin but a second invitation from that clinic to participate in the trial arrived.
It seems that each “new” patient has the privilege of being invited.

I pose the following questions:

  • Are you ever asked by your patients for guidance as to participating in a clinical trial?
    I do remember a grand old male patient who died a week after starting a trial years ago, and his wife has never recovered from the shock.

  • Are you happy, on behalf of your older patients, with the ethical standards that are in place for trials using older Australians as guinea pigs?

  • In this particular case, does the invitation fall into line with a recent guideline suggesting that Australians over 65 aren’t really going to benefit from “preventative” statin therapy?

  • Might the referring clinic get some sort of rebate based on accepting numbers of participants?

I know that clinical trials can play a role, and human guinea pigs are an important part of that.
However, the coordinating bodies (all very, very prestigious and NMHRC funded) must be held accountable where older Australians are jeopardizing their own long-term wellness.

Or am I too “patient-centric” ?

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