Untested Stem Cell Study

 

The Guardian – Friday 5 August 2016  by Melissa Davey

Australia has among the world’s highest concentrations of stem cell businesses advertising medical and cosmetic treatments online, despite a lack of evidence about the efficacy or safety of many of those procedures, a study has found.

A senior author on the paper, Prof John Rasko from the University of Sydney, has called on Australia’s medical regulator, the Therapeutic Goods Administration (TGA), to close a loophole that, he said, was allowing the businesses to promote and offer potentially ineffective or harmful treatments.

Websites frequently made implausible claims, were vague about the medical conditions for which they could treat or only offered information “on request” and used inconsistent terminology, the researchers found.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat some cancers, and blood and immune diseases, but those are among the few proven treatments. Clinical trials by academic centres are exploring the potential of stem cells to treat a wider range of diseases, including multiple sclerosis and diabetes.

However, some operators not affiliated with academic institutions are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

“Over the past decade the public has been very excited about the publicity surrounding stem cells, which are being advertised as nature’s own way of repairing the body,” Rasko said.

“We found an increasing number of operators that appear to be preying on the public’s vulnerability and advertising treatments without any proof that the thing they’re selling is actually working or even safe.”

What had shocked the researchers, Rasko said, was that so many clinics were now operating in Australia. They charged consumers thousands of dollars.

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Untested stem cell treatments proliferate in Australia, study finds | Australia news | The Guardian 5/08/2016, 12:51 PM

“It used to be that stem cell tourism was the only way to get these treatments, forcing Australians to fly to developing countries with less stringent medical regulations to get them,” he said.

Rasko said the reason stem cell clinics had been able to proliferate in Australia was due to a regulatory loophole that had never been closed.

Autologous treatments involve moving a person’s tissue or cells. For example, a vein would be removed from a patient’s leg and transferred into their heart to bypass a blocked blood vessel. The TGA declared that such treatments could not be considered therapeutic goods and, therefore, did not regulate their use.

It means stem cells taken from and used in the same patient fall into the category of autologous when the donor and the recipient are the same.

“It allowed doctors to take cells from any parts of the body, manipulate them and reinject them into the body,” Rasko said.

“It took shonky clinics years to realise they could take advantage of this but take advantage they certainly now have.”

Complicating matters is that stem cells used for medical practice and therapeutic purposes are overseen by different regulatory frameworks.

Following pressure from people like Rasko and concerns about the lack of regulation for unproven stem cell treatments, the TGA sought comments from a range of stakeholders and interested parties on whether the regulation applied to some autologous cells would be appropriate. Consultation closed in March last year but no action has been taken.

“A total of 80 submissions were received,” a TGA spokeswoman told Guardian Australia.

“Following this there were a large number of face-to-face meetings with healthcare professionals and other stakeholders and, based on these consultations, a second consultation paper will shortly be released by the TGA to try to resolve these concerns without constraining normal medical practice.”

Rasko hopes the research by him and his team, published on Friday in the journal Cell Stem Cell, will prompt the TGA to act with more urgency. He believes the World Health Organisation should also develop a policy to ensure guidelines were consistent between countries.

Australians have already died from undergoing expensive and unproven stem cell treatments. In June, a New South Wales coroner found that a 75-year-old woman, Sheila Drysdale, died after undergoing experimental stem cell treatment for her severe dementia.

Coroner Hugh Dillon found that Drysdale died as a direct result of blood loss suffered following the liposuction stem cell procedure that doctors claimed might improve her quality of life by reducing her symptoms.

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Untested stem cell treatments proliferate in Australia, study finds | Australia news | The Guardian 5/08/2016, 12:51 PM

The procedure was performed by a cosmetic physician at a private facility and Drysdale died shortly after arriving home.

Dillon said the death “highlights the vulnerability of elderly sick people and their families, desperate for help, to ‘quack’ medicine”.

“I recommend that the TGA and the NSW Ministry of Health consider how best to manage and regulate the provision of ‘experimental’ or ‘innovative’ medical or surgical procedures that have not yet been approved following clinical trials or other recognised peer-reviewed evaluation processes,” he said.

“Among the issues to considered, I recommend that the questions of potential conflict of interest and informed consent be given high priority.”

Do you know more? melissa.davey@theguardian.com

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Topics

Health (Australia) Medical research Stem cells Regulators New South Wales

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