Finally, unproven stem cell clinic practices might be curtailed

October 27, 2017 by Megan Munsie, Cameron Stewart And Ian Kerridge, The Conversation
There’s some good research being done in stem cells. But clinics peddling stem cell treatments largely lack evidence. Credit: www.shutterstock.com

In a welcomed move, the Therapeutic Goods Administration (TGA) has this week announced reforms will be introduced in 2018 to address long held concerns about the provision of unproven stem cell treatments to increasing numbers of Australian and international patients.

Regulation of stem cell treatments being offered outside hospitals will be increased. It will acknowledge the risks of these treatments, and advertising of certain treatments will be prohibited.

While more specific details are not yet available, it seems at last possible the most egregious practices of suburban stem cell clinics will be severely curtailed.

Stem cell marketing

Over the last six years, the number of private "stem cell" clinics operating across Australia has grown from a handful to more than 60. These clinics offer treatments for myriad conditions, from anti-ageing "facial rejuvenation" to treatment for osteoarthritis, lung diseases, infertility, motor neurone disease, dementia and multiple sclerosis.

Advertising their services online and in social media, the clinics use claims of efficacy and expertise to lure patients. But they offer little, if any, scientific proof their treatments work, and charge patients exorbitant fees for their services.

How is it these clinics have been able to flourish in Australia and provide unproven, expensive and potentially risky treatments to such a wide group of potential patients?

Stem cell clinics often rely on anecdotes and patient ‘testimonials’. Credit: Swiss Medica website

They have been able to exploit a loophole in TGA regulations that permits doctors to "transplant" a patient's own tissue back into their body, without that tissue having been subjected to ordinary controls and standards that apply to the transplantation of biological tissue products.

This "exclusion" was intended to enable doctors to use patients' own tissue to repair bone, joint, ligament and other injuries.

Stem cell risks

Some may argue adults should be able to make choices about their own health care, including to use innovative or unproven treatments. But there are harms in allowing stem cell clinics to operate as they do.

First, the collection and administration of stem is not without risk – some are very serious. In 2013, an Australian woman, Sheila Drysdale, died following complications from a liposuction used to the extract "fat stem cells" to treat her dementia – an indication that is not supported by any evidence.

More recently, three women have been left blind following "" in Florida for a type of retinal disease with their own "".

Second, stem cell "treatments" may cause other harms – including the financial burdens of these treatments (which are not Medicare rebated) on patients and their families, and the psychological harms vulnerable patients may feel from being tricked into paying for something that didn't work.

Private clinics shouldn’t be able to make claims without evidence. Credit: ASC Treatment website

Third, there are broader societal harms, including the erosion of public trust in established stem cell science, medical research and health care more generally.

This doesn't mean all stem cells are bad

The TGA has recognised the importance of enabling research and innovation in stem cell medicine. There is good work being done within hospitals and laboratories around the country, and patients should still have access to unapproved treatments through clinical trials and special access schemes.

But there remain some concerns. The TGA's loophole may have provided the impetus for the explosion in clinic numbers, but it's not the cause of some of the questionable behaviours engaged in by some clinics.

Laws exist to stop misleading and deceptive advertising, and there are strict regulations on the advertising of medical services. To date, these existing regulations haven't been employed by regulators such as the Australian Competition and Consumer Commission or the Australian Health Practitioner Regulation Agency to crack down on dodgy practices.

Mechanisms for registering clinical trials are already being manipulated by stem cell clinics and the stem cell industry more widely, to cloak themselves in the authority of science and "satisfy" regulatory and ethical concerns about their practices.

The dangers here are clear. While regulatory reform is welcome, they will remain ineffective unless the TGA and other regulatory bodies have the will, power and resources to enforce them. And unless this happens – patients will continue to be harmed.

Selling has been a big business in Australia for too long. After two public consultations and much deliberation, we have some action. Researchers, health practitioners, patients and regulators have an interest in making sure the proposed changes to the regulations work.

Explore further: FDA cites 'Significant deviations' at florida stem cell clinic

Related Stories

FDA cites 'Significant deviations' at florida stem cell clinic

August 29, 2017
(HealthDay)—A Florida stem cell clinic has received a warning letter from the U.S. Food and Drug Administration about what the agency describes as serious problems that could pose health risks to patients.

Medical tourism in spotlight as experts call for tighter regulation

July 5, 2017
Countries should unite to tackle unscrupulous advertising of unproven therapies involving stem cells, experts say.

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Stem cell clinics and businesses are registering for-profit, pay-to-participate

July 19, 2017
The Future Science Group (FSG) journal Regenerative Medicine, today announces the publication of a new Perspective article, in which Leigh Turner (University of Minnesota, MN, USA) discusses the urgent need for careful screening ...

US clinics avoiding government oversight of 'stem cell' treatments

May 1, 2015
Clinics across the United States are advertising stem cell treatments that attempt to take advantage of what they perceive as exceptions in FDA regulations, according to bioethicist Leigh G. Turner, PhD, Associate Professor, ...

Advanced economy nations have high rates of online marketing of stem cell therapies

August 4, 2016
Advanced economy nations led by Ireland, Singapore, Australia, Germany, Italy, Japan, and the United States have the highest per capita number of clinics engaging in direct-to-consumer marketing of stem cell therapies, according ...

Recommended for you

How defeating THOR could bring a hammer down on cancer

December 14, 2017
It turns out Thor, the Norse god of thunder and the Marvel superhero, has special powers when it comes to cancer too.

Researchers track muscle stem cell dynamics in response to injury and aging

December 14, 2017
A new study led by researchers at Sanford Burnham Prebys Medical Discovery Institute (SBP) describes the biology behind why muscle stem cells respond differently to aging or injury. The findings, published in Cell Stem Cell, ...

'Human chronobiome' study informs timing of drug delivery, precision medicine approaches

December 13, 2017
Symptoms and efficacy of medications—and indeed, many aspects of the human body itself—vary by time of day. Physicians tell patients to take their statins at bedtime because the related liver enzymes are more active during ...

Time of day affects severity of autoimmune disease

December 12, 2017
Insights into how the body clock and time of day influence immune responses are revealed today in a study published in leading international journal Nature Communications. Understanding the effect of the interplay between ...

Estrogen discovery could shed new light on fertility problems

December 12, 2017
Estrogen produced in the brain is necessary for ovulation in monkeys, according to researchers at the University of Wisconsin-Madison who have upended the traditional understanding of the hormonal cascade that leads to release ...

3-D printed microfibers could provide structure for artificially grown body parts

December 12, 2017
Much as a frame provides structural support for a house and the chassis provides strength and shape for a car, a team of Penn State engineers believe they have a way to create the structural framework for growing living tissue ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.