The hard sell of stem cells: we need a better way to protect patients from harm

As ABC’s 7.30 revealed last night, Australia has a flourishing stem cell treatment market. During these procedures, cells are taken from a patient and re-administered to them.

These “therapies” are being sold to patients with a wide range of debilitating and chronic conditions with little or no evidence of benefit. It’s also unclear whether stem cells are even being used in these treatments, despite the advertising claims.

Due to a lack of effective regulations, there is little oversight of these procedures and the businesses that provide them.

Regulatory loopholes

Operating in a regulatory loophole, these clinics and businesses are not required to meet the usual stringent standards required for therapeutic use of cells and tissues in Australia.

In response to concerns about unscrupulous and potentially harmful practices, and after years of inaction, the Therapeutic Goods Administration (TGA) is currently conducting a public consultation to gauge support for a change in how treatments involving the use of patient’s own cells and tissues are regulated.

Such a review is urgently needed. A recent quantitative survey revealed a dramatic increase in the number of Australian clinics marketing and providing these therapies. Australia currently has one of the highest concentrations of clinics per capita.

In the absence of effective regulation, business is booming. But it’s exposing people to unnecessary procedures – just look at the aggressive sales techniques of self-claimed entrepreneurs and the possibility of harm.

Such businesses also run the risk of compromising legitimate efforts in Australia to translate promising stem cell-based research into effective and safe therapies.

Read more:Stem cell therapies are advancing, but will Australian patients be left behind?

Flawed investigation process

Investigations of medical misconduct or false or misleading advertising are treated on a case-by-case basis after the patient, their family member or medical practitioner make a complaint to the TGA, the Australian Competition and Consumer Commission or the Australian Health Practitioner Regulation Agency.

Policing unproven stem cell treatments and their marketing based on this individualised process is problematic for a number of reasons.

Most significantly, it assumes people have the resources, will and empowerment to pursue a complaints process. It also assumes consumers will know which authority to turn to.

People who seek and undergo unproven or experimental stem cell treatment do so for a range of debilitating, often chronic, health conditions. They do so in the hope of a better quality of life and for some relief from day-to-day suffering.

They often have more urgent priorities beyond pursuing a complaint after being treated poorly or not getting the outcome they had hoped for. This is especially the case when such treatment has involved feelings of extreme disappointment, embarrassment and disempowerment by an exploitative process.

The family whose experience featured in the 7.30 report, for instance, did not wish to formally pursue a complaint despite being subjected to misleading, unethical and exploitative practices. Having raised concerns with Stem Cells Australia, the peak body representing stem cell science in Australia, they wished to put the unfortunate experience behind them.

Psychological harm

Our research indicates that the positive relationship patients forge with their stem cell treatment provider makes it unlikely they will lodge a formal complaint.

In our recent study, people described experiences of harm and concern about their care yet did not act. In addition to the financial difficulties associated with undergoing treatment (procedures generally cost A$9,000), concerns included:

• not being effectively anaesthetised during liposuction procedures to extract stem cells from fat

• experiencing extreme pain and the treating doctor (a cosmetic surgeon) refusing to stop the procedure in spite of repeated requests

• not consenting to what happened to their stem cells after procedures and then being invited to return for subsequent procedures at considerable cost

• concern that stem cells were not administered correctly into sites of injury

• being influenced to undertake procedures due to heavily reduced costs (A$4,000 reduced from A$10,000).

But patients remained grateful to their “stem cell doctor” despite these experiences. They were happy to have found someone who promised them treatment that could help and who was prepared to do something.

Following the tragic preventable death of Sheila Drysdale, who bled to death following a stem cell treatment for Alzheimer’s disease, the NSW Deputy Coroner ruled that Sheila died as a result of the poor performance of the doctor.

Yet the NSW Coroner’s Report stated Sheila’s husband bore the doctor “no ill-will”. As he explained to ABC’s Background Briefing, he still believed the treatment could have worked:

Had Sheila survived that night and not bled to death, we may have seen something very positive.

This story raises concerns ranging from ethical issues associated with lack of informed consent, to physical and psychological harm.

Diversion from mainstream medicine

These therapies may also cause harm by diverting people away from effective therapies.

A doctor in Western Australia recently described his serious concern about the harm inflicted on his patient who went off her medication for rheumatoid arthritis in order to undergo an unproven stem cell treatment.

As a result, she experienced a painful and sustained flare-up that may have caused permanent and avoidable damage to her joints. It is unlikely that indirect harms such as these are being reported to authorities.

A reliance on individual consumer complaints to a number of different agencies is an unsatisfactory approach to assessing and addressing harm associated with the exponentially growing Australian unregulated stem cell treatment industry. The TGA consultation closes on October 6. The TGA then needs to act swiftly to introduce meaningful regulatory reform.

Claire Tanner receives funding from the Australian Research Council.

Alan Petersen receives funding from from the ARC.

Megan Munsie receives funding from the Australian Research Council. She is Head of the Education, Ethics, Law & Community Awareness Unit at Stem Cell Australia.