GP’s experimental procedure leads to patient death

In a reported case, a GP was found guilty of professional misconduct by a state tribunal for his treatment of multiple patients including one who died after his treatment.

Five complaints were brought against the GP for inappropriate and unethical administration of stem cell therapy and prescribing of compounded peptides, as well as inadequate record keeping.

While this is an unusual case, it is a reminder to always ensure patient safety and comply with accepted standards when prescribing medications or performing experimental or non-standard procedures.

Stem cell therapy results in inquest

The GP, who had worked in cosmetic practice for two decades, performed stem cell therapy on patient A to improve frontal lobe dementia. Patient A resided permanently in a nursing home, and had dementia, as well as hypertension and atrial fibrillation.

Prior to the procedure, performed at the practice, patient A’s own GP, completed a medical history form which stated she was taking aspirin. Her GP had intended that she stop taking the aspirin four days before undergoing stem cell therapy. However, on the day of surgery, the GP in question did not check the patient’s medication chart which showed she had continued taking aspirin up until that morning.

After the procedure, records showed she had a fluctuating blood pressure and heart rate. Despite concerns raised by her relative, the GP did not consider that hospitalisation was necessary and discharged her to the nursing home. A few hours later, she died.

An inquest into patient A’s death, found she died from hypovolaemic shock, following uncontrolled blood loss due to stem cell therapy.

The lack of evidence of likely benefit and high risk of an adverse outcome led the tribunal to conclude it was completely inappropriate and unethical to administer stem cell therapy to a frail patient with advanced stage dementia.

Procedures performed without therapeutic indication

The GP was also scrutinised for performing stem cell therapy on a second patient (B) to treat bilateral vestibular dysfunction (BVD).

Evidence was accepted from patient B that he had not informed him stem cell therapy was an experimental procedure. The patient also said he had told him the procedure could repair damage in the body and was one hundred percent safe.

The tribunal accepted stem cell therapy was unproven in treating BVD and found its administration to patient B was improper and demonstrated a lack of appropriate care.

Lack of informed consent

The tribunal also found the informed consent process fell significantly below the expected standard in respect to patients A and B.

Evidence indicated patient A lacked capacity to provide informed consent. Patient A’s relative had signed a consent form but the GP did not check the relative’s authority to give consent. Although her relative held an Enduring Power of Attorney, this only gave the relative power to deal with financial matters, not medical consents. The consent form was a generic consent form that failed to disclose the material risks inherent in the procedure, including haemorrhage and death.

The tribunal accepted patient B’s evidence that he was not given any information sheets and was told the stem cell therapy was 100% safe. There was no note regarding a discussion about consent in the medical records, nor a signed consent form.

Improper and unethical prescribing

The complaints also centred on the GP’s prescribing of peptides to three patients with pudendal neuralgia, motor neurone disease and advanced osteoarthritis, as well as extensive self-prescribing of peptides and Schedule 4 and Schedule 8 drugs.

The tribunal found the peptides prescribed were not clinically indicated for muscle growth or improving pudendal nerve function, tender hamstrings and muscle weakness. Furthermore, there was a lack of clinical trials to support the safe and efficacious prescribing of peptides, and contraindications and recommended doses were unknown.

Evidence showed the GP had failed to keep adequate records regarding his prescribing of peptides. This included failing to document the patient’s medical history and examination, and written consent.

His self-prescribing was also found to be improper and unethical, and breached the Medical Board of Australia’s Code of Conduct, which stipulates doctors should seek independent objective advice for their own medical care and be aware of the risks of self-diagnosis.

Doctor voluntarily surrenders registration

The tribunal found the majority of the complaints against the GP were proven and represented a “reckless disregard for patient safety.” The tribunal endorsed comments from the State Deputy Coroner, in the findings of the inquest into patient A’s death, describing the stem cell therapy as being comparable to “quack” medicine. Ultimately, he was found guilty of professional misconduct.

The GP was not registered at the time of the hearing. Nevertheless, the tribunal declared that if he had been, his registration would have been cancelled. He was precluded from seeking a review of the decision for seven years and ordered to pay the complaint body’s costs.

Key lessons

This case emphasises the importance of providing patients (or, if they lack capacity, their substitute decision-makers) with sufficient information to ensure they can make an informed decision about their treatment. This includes informing patients you are using a new, non-standard or experimental approach. Ensure you:

• Discuss with the patient the place of the experimental treatment or procedure among the options available, including the evidence supporting it and any clinical experience using it.
• Explain your rationale for recommending the treatment in comparison with other options.
• Outline your experience and training using the new approach and whether you will be supervised or assisted.
• Cover potential risks and complications, as well as potential benefits.
• Explore with the patient what is important to them in terms of outcomes – what would they be prepared to live with?
• Make it clear that long term outcomes and expectations may be unknown.

Finally, comprehensively document the discussion in the patient’s records and obtain signed consent. If the patient does not have capacity, ensure you have identified the correct substitute decision-maker to make the treatment decision on behalf of the patient. View our flowcharts on substitute decision-making outlining how to do this in your state or territory and our factsheet, ‘Capacity: the essentials’.

It is also important for doctors to regularly assess their prescribing habits. This means only prescribing medications that are therapeutically indicated and not unnecessarily exposing patients to adverse side effects.

Be thorough when recording your consultations – note down the therapeutic indication as well as the dosage, frequency and period of prescription. Complete our e-Learning modules,  and .

Good medical practice involves having your own GP and seeking independent, objective advice when you need medical care, and being aware of the risks of self-diagnosis and self-treatment.

More information

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