Dying woman and ethical doubts spark probe into cannabis cancer ‘cure’

A project researching the use of cannabis to treat cancer is under investigation amid allegations of inadequate ethical approvals in the use of human tissue and potentially improper tests being run on a dying woman.

The project was a partnership between ASX-listed cannabis company Ecofibre and the University of Newcastle, and involved taking tissue samples from hospital patients for cannabis-based drug tests.

Credit: Monique Westerman

Ecofibre and the university launched the research partnership in 2021 to study the effect of the company’s cannabis formulation on gynaecological disorders including endometriosis.

In October that year, Ecofibre issued a press release claiming its researchers had discovered their drug “completely eradicated” diseased cells in several gynaecological conditions, including cancer.

Now, this masthead can reveal, the university is investigating the project as former laboratory members express concern the research may have lacked necessary consent and ethics approvals.

Patent applications stemming from the project and lodged in 2021 also reveal the cannabis-based drugs were “tested” on human cancer patients – despite a formal clinical trial not slated to launch until later this year.

“This strikes me as probably unethical behaviour, and possibly very unethical behaviour, but there is not enough information to know which,” said Professor David Vaux, a leading expert on research integrity.

The University of Newcastle’s investigation is centred on the project’s ethical approval and use of so-called “organoid” human tissue, say two sources with knowledge of the process who spoke anonymously to detail confidential information.

Organoids are small cellular models of reproductive organs, grown from patient cells, which for this project were harvested at the hospitals surrounding the University of Newcastle.

The federal government’s National Statement on Ethical Conduct in Human Research requires scientists collecting human tissue samples to obtain both ethical approval from a human research ethics committee and consent from the patient.

The University of Newcastle

One former laboratory member, speaking on condition of anonymity to protect their employment, told this masthead they believed they had been working with samples before ethics approval was in place.

“I started definitely before the approval,” they said. “The human ethics, I don’t think it was approved at that time, because we were writing it.”

University of Newcastle Pro Vice-Chancellor of Research Professor Juanita Todd said it would be inappropriate to comment until the review was completed.

Hunter New England Local Health District, which runs hospitals in the Newcastle area, said it had contacted all patients involved in the studies and was fully co-operating with the investigation.

“Participation in the studies did not impact any patient’s treatment, and all patients received appropriate, safe care within our hospitals,” a health district spokesman said.

Ecofibre said in a statement it did not have details of the university’s investigation or any outcomes.

“We have, however, been advised that the efficacy of the research itself is not impacted, and the research outcomes were not part of the investigation,” it said.

Ecofibre was once among Australia’s biggest medicinal cannabis firms, listing on the Australian Securities Exchange in 2019, and at its peak of $3.79 per share, valued at well over $1 billion. Its shares now trade at just 3¢.

The company promotes the cancer research in marketing its cannabinoid vaginal suppositories known as “Endo Relief Melts”.

“It was not a clinical trial. This was like: ‘Hey, these things are legal-ish, right?’”

Source involved in the project

Testing on humans begins

In late 2021, the university and Ecofibre filed four applications to the US Patent Office for treating endometriosis and ovarian cancer with various cannabis and hemp formulas.

One application said the research had progressed to “further testing within human patients” despite Ecofibre telling this masthead it planned to start human trials on the cannabis product it was testing with the university only this year.

The application describes the 2021 human tests as beginning after the research team was approached that year by a 31-year-old woman with end-stage endometrial cancer seeking “help”.

“I was connected to her, through a person within [Ecofibre] in Australia,” said a person directly involved in the research project.

“And I said, ‘f---, we have no idea, we don’t know’. If you want to try something, here’s a best-guess. It was not a clinical trial. This was like: ‘Hey, these things are legal-ish, right?’”

This masthead is not naming the woman, who has since died, after her family asked that she not be identified.

The university grew organoids from her cancer, before testing them against various combinations of chemotherapy and cannabis extract, the person with direct involvement in the project said.

The research project source said she was not part of the official organoid study.

A university employee contacted Ecofibre to get the woman access to the formulation “we are testing for you”, an email seen by this masthead shows.

The patient was then treated with the combination, which the patent applications say led to a “complete metabolic response”, meaning the woman’s cancer was nearly completely resolved.

The patents note that the woman still died due to earlier rounds of chemotherapy causing extensive organ damage.

“There is no telling whether she could have achieved earlier remission and prevented extensive organ damage due to numerous unsuccessful rounds of chemotherapy, had she utilised [cannabis extract] treatment,” the research team wrote in the patent.

A second patient with head and neck cancer was also advised to try a full-spectrum cannabis extract and achieved remission, the patents say.

Merle Spriggs, a bioethicist and former member of the Royal Children’s Hospital Clinical Ethics Committee, said the case seemed to raise ethical questions, including whether the researchers had appropriate approvals from a human research ethics committee.

“What is the point of the pre-clinical research? The researchers seem to be already offering advice or guidance. The scientific basis for doing research seems to have been ditched,” she said.

While not commenting on the specific case at Newcastle, a National Health and Medical Research Council spokesperson said researchers were “not permitted to offer treatment advice to ‘members of the general public’ or even to specific patients with a life-threatening medical condition based on the results of a test conducted as part of pre-clinical research”.

Ecofibre said the case was not part of the research agreement between it and the university, despite it being mentioned in the patent jointly submitted by both parties.

An Ecofibre spokesman said the company operated under the “fundamental principle that we do not conduct or endorse testing on humans outside of ethically approved clinical trials”.

‘Egregious financial misconduct’: EcoFibre lawsuit

Separately, Ecofibre is being sued by its former chief scientific officer and two other former senior executives, with allegations of egregious financial misconduct at one of its US companies.

Ecofibre’s former chief scientific officer, Alex Capano, who was directly involved in the University of Newcastle research project and is named on some of the patents, is now suing the company in the US courts.

She claims in court filings made earlier this year that the company sacked her after she brought to the board’s attention examples of “egregious financial misconduct”.

Capano says a senior manager and others at Ecofibre intentionally overvalued EOF Bio, the subsidiary company she led, at $30 million.

In its legal response, Ecofibre denied the allegations. The company has asked for her complaint to be dismissed outright.

It is also trying to strike out legal action taken against it in the United States by two other former executives.

“Ecofibre considers the civil complaint commenced by three former employees relies on assertions that are factually incorrect and without foundation,” an Ecofibre spokesman said. “The company is vigorously defending the litigation and has filed its motion to dismiss.”

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