‘Pay-to-Participate’ stem cell clinical studies, the ugly stepchild of ClinicalTrials.gov

When patients are looking for clinical trials testing new drugs or treatments for their disease, one of the main websites they visit is ClinicalTrials.gov. It’s a registry provided by the National Institutes of Health (NIH) of approximately 250,000 clinical trials spanning over 200 countries around the world.

ClinicalTrials.gov website

If you visit the website, you’ll find CIRM’s 28 active clinical trials testing stem cell-based therapies for indications like spinal cord injury, type 1 diabetes, heart failure, ALS, cancer and more. These are Food and Drug Administration (FDA)-approved trials, meaning that researchers did the proper preclinical studies to prove that a therapy was safe and effective in animal models and received approval from the US FDA to test the treatment in human clinical trials.

As the largest clinical registry in the world, ClinicalTrials.gov is a very valuable resource for patients and the public. But there are studies on the website that have recently surfaced and taken on the role of ‘ugly stepchild’. These are unapproved stem cell therapies from companies and stem cell clinics that are registering their “pay-to-participate treatments”. And they are doing so in clever ways that don’t make it obvious to patients that the trials aren’t legitimate. The reason this is so troubling is that unproven therapies can be dangerous or even life-threatening to patients.

Leigh Turner

Leigh Turner, an associate professor of bioethics at the University of Minnesota, has written extensively about the serious problem of stem cell clinics marketing unproven stem cell therapies to desperate patients. Turner, in collaboration with UC Davis professor Dr. Paul Knoepfler, published a study in Cell Stem Cell last year that identified over 550 clinics in the US that promote unproven treatments for almost any condition, including diseases like Alzheimer’s where research has shown that cures are a long way off.

Today, Turner published an article in Regenerative Medicine that shines a light on how companies and clinics are taking advantage of ClinicalTrials.gov to promote their “pay-to-participate” unproven stem cell studies. The article is available for free if you register with RegMedNet, but you can find news coverage about Turner’s piece through EurekAlert,  Wired Magazine and the San Diego Union Tribune.

In an interview with RegMedNet, Turner explained that his research into how businesses promote unproven stem cell therapies led to the discovery that these studies were being listed as “pay-to-participate” on ClinicalTrials.gov.

“Many of these businesses use websites, social media, YouTube videos, webinars and other tools to engage in direct-to-consumer marketing of supposed stem cell therapies. To my surprise, at one point I noticed that some of these companies had successfully listed “pay-to-participate” studies on ClinicalTrials.gov. Many of these “studies” look to me like little more than marketing exercises, though of course the businesses listing them would presumably argue that they are genuine clinical studies.”

While FDA-approved trials can charge study participants, most don’t. If they do, it’s motivated by recovering costs rather than making a profit. Turner also explained that organizations with FDA-approved studies “need to prepare a detailed rationale and a budget, and obtain approval from the FDA.”

Companies with unproven stem cell therapies are ignoring these regulatory requirements and listing their studies as “patient-funded” or “patient-sponsored”. Turner found seven such “pay-to-participate” studies sponsored by US companies on ClinicalTrials.gov. He also identified 11 studies where companies don’t indicate that patients have to pay, but do charge patients to participate in the studies.

Turner is concerned that these companies are using ClinicalTrials.gov to take advantage of innocent patients who don’t realize that these unproven treatments aren’t backed by solid scientific research.

“Patients have already been lured to stem cell clinics that use ClinicalTrials.gov to market unproven stem cell interventions. Furthermore, some patients have been injured after undergoing stem cell procedures at such businesses. Many individuals use ClinicalTrials.gov to find legitimate, well-designed, and carefully conducted clinical trials. They are at risk of being misled by study listings that lend an air of legitimacy and credibility to clinics promoting unproven and unlicensed stem cell interventions.”

Having identified the problem, Turner is now advocating for a solution.

“ClinicalTrials.gov needs to raise the bar and perform a proper review of studies before they are registered. Better screening is needed before more patients and research subjects are harmed. It’s astonishing that officials at the NIH and US FDA haven’t already done something to address this obvious matter of patient safety. Putting a disclaimer on the website isn’t sufficient.”

The disclaimer that Turner is referring to is a statement on the ClinicalTrials.gov website that says, “Listing of a study on this site does not reflect endorsement by the National Institutes of Health (NIH).”

Turner argues that this disclaimer “simply isn’t sufficient.”

“Patients and their loved ones, physicians, researchers, journalists, and many other individuals all use ClinicalTrials.gov because they regard the registry and database as a source of meaningful, credible information about clinical studies. I suspect most individuals would be shocked at how easy it is to register on ClinicalTrials.gov studies that have obvious methodological problems, do not appear to comply with applicable federal regulations or have glaring ethical shortcomings.”

While Turner acknowledges that the NIH database of clinical trials is a “terrific public resource” that he himself has used, he regards it “as a collective good that needs to be protected from parties willing to misuse and abuse it.” His hope is that his article will give journalists the starting material to conduct further investigators into these pay-to-participate studies and the companies behind them. He also hopes that “such coverage will help convince NIH officials that they have a crucial role to play in making ClinicalTrials.gov a resource people can turn to for information about credible clinical trials rather than allowing it to become a database corrupted and devalued by highly problematic studies.”

Convincing is one thing, but implementing change is another. Turner said in his interview that he knows that “careful screening by NIH officials will require more resources, and I am making this argument at a time when much of the political discourse in the U.S. is about cutting funding for the CDC, FDA, NIH and other federal agencies.”

He remains hopeful however and concluded that “perhaps there are ways to jolt into action people who are in positions of power and who can act to help prevent the spread of misinformation, bad science, and marketing packaged as clinical research.”

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7 thoughts on “‘Pay-to-Participate’ stem cell clinical studies, the ugly stepchild of ClinicalTrials.gov

  1. People who contact me about stem cell treatments often have looked at the clinicaltrials.gov site or at another site (such as the Michael J. Fox foundation) that pulls information from the .gov site. It’s painful for me to explain that the NIH does not vet the entries. I have a suggestion for the NIH- why not create a peer-review system for clinicaltrials.gov entries? Send the information to a group of scientists with appropriate expertise, and ask them to critique the entry. The NIH would, as it does for grants, provide guidance for the review. If the entries are rejected, they couldn’t be listed without responding to the critique and resubmitting. It’s what we do to obtain NIH grants, so it shouldn’t be very difficult.

  2. It is disappointing that someone of Leigh Turners standing and scientific background can be so unscientific.
    Comments such as ” many of these “studies” look to me like…”. He does not produce any objective evidence to support this conjecture but passes it off as scientific research.
    They may in some instances be true but he has no data to help decide whether they are or are not.These sorts of statements reduce his articles to gossip and rumour mongering.
    It is true that all trials should be subject to ethics committee approval. If this has happened then any short comings are not with the registry they are with the ethics committee.

  3. Problems with Clinicaltrials.gov surfaced a few years ago in terms of stem cell clinics using it.
    See here my heads up on the problem back in 2014: https://ipscell.com/2014/10/clinicaltrials-gov-mission-at-risk-from-proliferating-for-profit-trials/
    and a first sign of trouble in my interview a month earlier with the Director of Clinicaltrials.gov Dr. Zarin:
    https://ipscell.com/2014/09/behind-the-scenes-at-clinicaltrials-gov-with-director-deborah-zarin/
    Paul

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