Medicopolitical

Verdict delivered for medical oncologist in chemo under-dosing scandal


Dr John Grygiel, the medical oncologist accused of underdosing cancer patients at Sydney’s St Vincent’s Hospital has been found guilty of professional misconduct and given a two year deregistration penalty.

A case brought by the Healthcare Complaints Commission related to events that occurred prior to 2015, when Dr Grygiel had a standard practice of prescribing a flat dose of 100mg carboplatin as part of adjuvant chemoradiotherapy for patients with head and neck squamous cell carcinoma.

The Civil and Administrative Tribunal of NSW heard from expert witnesses that this practice was at variance with the recommended prescribing protocol of doses based on area under the curve (AUC).

Dr Grygiel argued that his approach was aimed at minimising toxicity to patients, and he asserted there was no evidence that patients were harmed by the use of flat doses.

The tribunal heard different expert opinions about whether the dosing used was significantly below standard, but noted that Dr Grygiel was alone in adopting the schedule. Crucially he did not inform his patients that he was using a non-standard treatment or that other options were available.

“Notwithstanding the practitioner may have had good intentions and believed he was correct in prescribing as he did with the aim of reducing toxicity or potential adverse toxicity he was isolated in his beliefs and practices, being the only Australian practitioner prescribing as he did,” it noted.

“He did not conform to well recognised prescribing supported by appropriate peer reviewed studies and/or meta-analysis or even prescribing adopted by a small but reputable body of the profession. If he wished to prescribe as did, he should have done so in a clinical trial setting with all the necessary ethical safeguards in place.”

“Failure to adhere to a proper consent process lies at the heart of these proceedings,” it concluded.

“His lack of explanation denied his patients the opportunity to enquire about standard treatments or to seek a second opinion.”

In his submissions, Dr Grygiel said he had acted in the best interest of each of his patients and believed that the most effective treatment was based on a combination of scientific evidence and clinical judgment.

He argued there was no evidence that a 100mg dose of carboplatin was inferior as a radio-sensitiser than other doses in clinical trials with radiotherapy and said he saw no need to increase the dosage to AUC “in circumstances where was no evidence that this would increase the efficacy of treatment, but would increase the side effects my patients suffered”.

Expert witnesses acknowledged that Dr Grygiel was a highly experienced medical oncologist and treatment adequacy should not be judged simply on the basis of compliance with guidelines.

“To suggest that clinical experience and acumen can be simply replaced by following guidelines and that compliance with guidelines is some quasi index of clinical appropriateness is insulting to medical oncologists, including me, who have spent years in clinical practice,” said one.

However there were also conflicting claims about whether the multidisciplinary team at St Vincent’s was aware of and endorsed Dr Grygiel’s dosing philosophy.

“We conclude, at the relevant time … there was not a vigilant, collegiate, cohesive culture operating in the MDT at St Vincent’s. This circumstance, no doubt, contributed to the practitioner’s practises remaining undiscussed or unchallenged until mid-2015,” the tribunal stated.

The HCCC called for a disqualification period of eight years, but the tribunal noted that Dr Grygiel had been subject to considerable stress from being sacked, stripped of his professorship and subject to abuse including death threats as a result of media attention including the broadcast of an ABC 7.30 Report. It also noted character references from numerous medical oncologists attesting to Dr Grygiel’s integrity and trustworthiness.

Since he had already cancelled his medical registration the tribunal ordered that he be banned from seeking re-instatement for two years.

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