Author Topic: (Lancet) Dangers of unregulated stem-cell marketing  (Read 59 times)

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Offline agate

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(Lancet) Dangers of unregulated stem-cell marketing
« on: October 20, 2017, 04:29:32 pm »
From The Lancet, October 20, 2017:

The dangers of unregulated stem-cell marketing

Dara Mohammadi

In 2014, reality TV star Kim Kardashian had a high-profile facial. The beauty treatment was publicised to millions through social and general media and was reported to be able to rejuvenate the skin, thanks to one special ingredient—stem cells.

“It's ridiculous, the level of pseudo-science nonsense that the public are exposed to around stem cells”, says Timothy Caulfield, a professor of health law at the University of Alberta, Canada. “If it's not celebrities getting facials, it's sport stars going off for radical stem-cell treatments. The perception that people get is that stem cells are like little magic helpers that can do all sorts of things. That idea is dangerous.”

The danger is that it legitimises and feeds an altogether darker problem—the growth of unregulated clinics selling risky, untested, and unproven stem-cell treatments to patients. “We're not talking about a few rogue clinics”, adds Caulfield, “we're talking probably hundreds of clinics around the world, advertising, exaggerating benefits, and selling services for everything from anti-ageing procedures to treatments for backaches, multiple sclerosis, and [amyotrophic lateral sclerosis]”. He says that only few stem-cell treatments have been approved for use, including for some types of cancers and for severe burns.

In July, with a group of international researchers, Caulfield published a call to action for the development of international regulations to crack down on the marketing of unproven stem-cell treatments. Given the nature of the market, nobody knows the true scale of the problem, but Caulfield estimates that tens of thousands of patients (including many children) have already been affected. With patients paying up to US$100 000 per treatment, this unregulated global market is worth hundreds of millions of dollars.

The treatments can be dangerous. In the USA, for example, recipients of such treatments have developed painful bone fragments in their eyelids or mucous secreting nasal tissue in the spine. Increasing the risk of cancers is an ever-present concern with stem-cell treatments.

The most experimental and invasive procedures are done in clinics in countries such as India and China, says Caulfield, but loopholes in US regulation allow North American clinics to get away with offering treatments. Clinics argue that if a treatment uses autologous cells (stem cells obtained from the same patient who will receive them), they are not pharmaceuticals and thus fall outside of the US Food and Drug Administration's (FDA's) remit.

This loophole was used by a private clinic in Sunrise, FL, which, on inspection by the FDA this year, was found to be processing adipose tissue into stem cells and injecting them into patients with diseases such as Parkinson's disease, chronic obstructive pulmonary disease, or pulmonary fibrosis. On Aug 28, the FDA posted a warning letter to the clinic for marketing stem-cell products without its approval. In the public warning, FDA Commissioner Scott Gottlieb sent a shot across the bows of other clinics selling similar treatments, saying that the Association is stepping up enforcement actions against clinics abusing the trust of patients and potentially endangering their health with unapproved cell therapies.

Walking the line between over and under regulation

The argument for less restrictive regulations is that it could help speed up the translation of promising research to clinically useful treatments. However, balancing the desire to help patients as soon as possible with making sure that treatments are properly tested is tricky for doctors such as Paolo De Coppi, a paediatric surgeon at Great Ormond Street Hospital and Head of University College London's Institute of Child Health Centre for Stem Cells and Regenerative Medicine in London, UK.

“I have parents of patients coming to me after they have read about a stem-cell treatment online, usually on social media, and asking me if they can try the treatment”, he says, “…you feel you are not helping by pointing out that the treatment they read about is not a valid treatment, sometimes not even scientifically plausible. As a doctor you can feel like you let them down a bit.”

The regulatory environment in the UK and Europe, he says, is better than that in the USA, given that, whether autologous or not, stem-cell treatments fall under the jurisdiction of the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency. “We have a compassionate exception here that, for patients with no other treatment possibilities, they can potentially have access to a one-off cellular therapeutic, provided the application passes an ethical and scientific board”, he says. “These types of single-use therapies can then become justification to run a trial.”

Unregulated international clinics, he says, might claim they are part of this translational process, but that treatment decisions do not go through ethical and scientific committees puts patients at risk. Also, the data—positive or negative—go unpublished.

Stem-cell treatments hold undoubted potential, says De Coppi. “Recent work with stem cells reversing blindness in macular degeneration is a huge leap forward that I would not have predicted 2–3 years ago”, he says. He adds that stem cells for cardiac and neurological disorders are also exciting areas.

The UK Stem Cell Foundation, a funding organisation and charity based in London, UK, was set up in 2005 to speed up the translation of promising stem-cell-based therapies to the clinic. Brendon Noble is a stem-cell scientist who sits on the Foundation's board. “Some stem cells do have the potential to turn into any cell and to remain as that cell type but one has to know how to make them do that first”, he says. “You don't just squirt them around the body and hope that, first, they find the right place to repair and, second, that they turn into the right cell when they get there. The vast majority of unregulated activities don't even have a credible scientific basis, it's not just that they haven't gone through process—they simply don't make a lot of sense.”

A worry for Noble and the UK Stem Cell Foundation is that serious setbacks such as deaths and cancers in patients who receive unregulated treatments can have a negative effect on the whole field. “I harken back to the gene-therapy debacle [the 1999 death of a patient in a gene-therapy trial], which set the gene therapy field back almost 10 years”, he says. “I honestly believe that stem cells can be the next major development in medicine—we're talking organ transplantation and penicillin level change—which could potentially be destroyed or seriously set back by unregulated activity.”

Need for an international standard

That progress in stem-cell research could be hindered by unregulated activity prompted Caulfield and colleagues' call to action. “I'm not naive, I know that regulation at an international level is going to be really tough”, says Caulfield. “This is an internet-based phenomenon with direct marketing to patients, testimonials on websites. There are so many different kinds of regulatory bodies involved and it will be hard to coordinate. In addition, you've got a need for international collaboration to stop stem-cell tourism. That'll be logistically, as well as politically, difficult as you'll have some jurisdictions trying to position themselves as leaders in stem-cell translation. We're going to need international standards to stick to.”

Noble agrees with the need for standards, and says that, given that stem-cell technology is a potential game changer, it will need a new set of regulatory rules. “It doesn't help that we are trying to regulate stem-cell therapy development in an environment designed primarily for pharmaceuticals”, he says. “There are important diffe-rences between stem-cell therapies and pharmaceuticals, that mean this isn't necessarily appropriate or efficient.” On Aug 28, Gottlieb said the FDA will be advancing a policy framework bespoke to cellular therapies this autumn.

The differences, Noble says, are that unlike drugs, no two batches of stem- cell treatments will be absolutely the same, giving more variability in the product. That you inject live cells into the body means that the treatment cannot be reversed easily, and the technology needed to monitor cell migration and keep track of cells once in the body is not yet as advanced as pharmacokinetic techniques.

Caulfield feels that the fraudulent nature of unregulated activities might offer leverage for the development of international policing. “I don't know what every provider believes, but somewhere along that food chain, for a lot of these products, there is someone who knows the stuff doesn't work and there's someone who knows that they're not being honest about the efficacy”, he says. “That's more than just wishful thinking, it's fraud.”

Doctors and medical associations have a part to play. “My own research has shown that regulated health professionals are associated with these clinics, so bodies that regulate medical professionals have leverage there”, he says. “In North America for a start, let's get the colleges of physicians and surgeons to make sure that their members aren't making false promises about stem-cell therapies.”

More aggressive control on advertising is easier said than done. “Doctors and scientists need to get involved in that online conversation and set it straight when they see erroneous information—whether that's through social media or going on talk radio, they mustn't shy away from the conversation”, he says. “If the scientific community don't get involved in the education of the public it's a win for the people selling and promoting these bunk treatments.” Given the potential consequences of an unregulated stem-cell industry spiralling out of control, a win for the clinics will, ultimately, be a loss for patients.

The article can be seen here.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.


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