ClinicalTrials.gov is run by the National Institutes of Health to give a comprehensive list of all registered clinical studies around the world. But the site, mandated by an act of Congress, doesn’t properly vet these studies for legitimacy, said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics.
Turner described what he called serious abuses of the site in an article to be published Wednesday in the journal Regenerative Medicine. The paper will be available online at http://bit.ly/2uZl7XR (free registration is required).
Among the website’s questionable listings are those from companies charging for experimental stem cell treatments — including 11 where the fees aren’t even disclosed, Turner said. Most legitimate clinical trials don’t charge patients for experimental treatment, he and other experts have said.
In addition, some studies marketed on the website don’t follow proper ethical and scientific procedures. Therapies can be hyped beyond what the scientific evidence supports, and some patients selected for participation actually don’t qualify for the treatment.
To stop such abuses, the NIH needs to perform more extensive checks of the clinical trials it lists, Turner said. And that effort would require money.
“You probably need human beings putting actual eyeballs on these studies and making sure if they are complying with federal law,” Turner said.
For example, in some cases cash-poor companies with promising treatments are allowed to charge patients to recover costs, he explained. But they aren’t allowed to make a profit on it. These exceptions are granted by the Food and Drug Administration, which authorizes clinical trials in the United States.
ClinicalTrials.gov is meant to provide a central place of reference for the vast numbers of clinical trials offered. The portal allows users to easily search for clinical trials by the therapy used, disease to be treated, location of treatment and other criteria.
The results can be daunting in their abundance, leaving patients with many choices but little to guide them on determining which therapies might be most appropriate for them. A keyword search for active clinical trials involving stem cells turned up more than 1,800 results Tuesday, and on the same day, the site listed nearly 200,000 trials for all medical conditions.
Currently, it’s up to patients and their caregivers to conduct their own research to verify whether a study is legitimate, Turner said.
Misplaced trust?
Over the years, stem cell scientists have voiced concerns about ClinicalTrials.gov. Because the website is operated by a federal health agency, it’s widely viewed as a trusted place for information. Companies that use the site as a marketing tool feed off that trust, Turner said.“One such company was recently the subject of considerable news media scrutiny after clinicians independent from the business published a study documenting that three of its patients suffered severe vision loss after paying $5,000 per person for stem cell interventions that were supposed to treat their age-related macular degeneration,” his new article said.
At least one of the blinded patients reportedly learned of the company from a listing on ClinicalTrials.gov.
On Tuesday, the NIH issued a statement saying it agrees that patients should know the risks and benefits before participating in a clinical trial, and that it provides resources to help them do so.
“We continue to evaluate ways to improve our outreach and engagement with stakeholders, including making our resources more prominently available and easier to digest,” the agency said.
“We added a prominent disclaimer on the (ClinicalTrials.gov) homepage in March 2017 stating that, ‘Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study,’” the NIH said.
Go to j.mp/nihstem for more of the agency’s information on stem cell clinical trials.
At the University of Southern California, medical researcher Katja Reuter said she hadn’t been aware of the extent of the problem, but agreed with Turner’s messaging after reading his new paper.
“The success or the usefulness of ClinicalTrials.gov depend on whether investigators and sponsors make a diligent effort to submit complete and accurate information. It was not intended as a system where the NIH and other groups that are involved have full oversight over the information,” said Reuter, ???an assistant professor of clinical preventive medicine at USC’s Keck School of Medicine.
“In defense of the NIH, they have no capacity to really look at the information in detail. It’s not possible,” she said. “They don’t have the resources. And they make it very clear that it’s the responsibility of the sponsor and investigator to provide that information.”
Reuter also said patients interested in any of these therapies should talk them over with a trusted health-care professional.
She’s tackling a different problem in clinical trials: recruiting enough patients so they can be conducted. Some clinical trials fail because of a lack of patients, meaning that potentially valuable new treatments never get a chance.
Patients on their own
Clinicaltrials.gov was created under the 1997 Food and Drug Administration Modernization Act. The law mandates listing of all registered clinical trials, whether conducted by public agencies or private companies. The intent was to give patients and health care professionals a single point to find potential therapies.The need for more oversight is especially great for stem cell therapies because of the great expectations for this relatively new branch of medicine. Stem cell therapy has great potential to cure diseases and injuries not now effectively treated, and this potential is slowly being demonstrated in regulated clinical trials.
However, a vast number of unregulated treatments — some legitimate and some not — are being offered by doctors and clinics around the world. Discerning what’s legitimate and what’s dubious can be extremely complex for people not familiar with the science.
Stem cell offerings proliferate
In a study published in June 2016, Turner and UC Davis stem cell researcher Paul Knoepfler documented at least 351 companies that advertise unauthorized stem cell treatments at their clinics. While many of the therapies offered may be beneficial, others can be harmful.California had 113 of these clinics, the most of any state, the study found. And Southern California was the epicenter. Beverly Hills had the most of any city in the country, with 18 such clinics.
As an example of this marketing push to patients, Turner linked on Twitter to a job advertisement for a stem cell sales representative.
“Are you a motivational speaker?” the ad began. “Are you interested in educating the public about a new and exciting field of medicine? Do you have experience as a sales professional?”
“This job is for a proven salesperson/public speaker/clinic rep who has charisma and charm, who can connect with and educate older clientele, doctors and nurses,” the ad continued. “The ideal candidate is a quick learner, passionate about helping people and financially driven.”
“This job involves 2 days per week in the clinic, educating and teaching prospective patients about Stem Cell Therapy and then getting them to commit and buy this amazing treatment.” (Capitalization style as in the ad). “Each sale earns a 1%, 3% or 5% commission.”
Toward the end, the ad stated that applicants, “must have a verifiable history of sales and either public speaking or motivational speaking.”
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